EP4395703A1 - A device for treatment of aneurysm of a blood vessel - Google Patents

A device for treatment of aneurysm of a blood vessel

Info

Publication number
EP4395703A1
EP4395703A1 EP22765165.0A EP22765165A EP4395703A1 EP 4395703 A1 EP4395703 A1 EP 4395703A1 EP 22765165 A EP22765165 A EP 22765165A EP 4395703 A1 EP4395703 A1 EP 4395703A1
Authority
EP
European Patent Office
Prior art keywords
blood vessel
vessel
segment
vessel member
aorta
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22765165.0A
Other languages
German (de)
French (fr)
Inventor
Peter Forsell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Implantica Patent Ltd
Original Assignee
Implantica Patent Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/EP2021/073893 external-priority patent/WO2022043555A1/en
Application filed by Implantica Patent Ltd filed Critical Implantica Patent Ltd
Publication of EP4395703A1 publication Critical patent/EP4395703A1/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00221—Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00734—Aspects not otherwise provided for battery operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00889—Material properties antimicrobial, disinfectant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A61B5/02014—Determining aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels

Definitions

  • the present invention relates to a device for treating a vascular aneurysm of a human or mammal patient.
  • An aneurysm is a blood-filled dilation (balloon-like bulge) of a blood vessel, caused by a weakened vessel wall.
  • the weakened vessel wall can be congenital, or be a result from a gradual weakening by for example high blood pressure (hypertension).
  • the bulge extends radially perpendicular to the direction of the blood flow in the vessel.
  • the aneurysm will naturally grow larger with time, thus, increasing the fatal risk of rupturing the vessel. If left undetected and given enough time, the aneurysm will inevitably grow and reach its bursting point.
  • the abdominal aorta is the part of the aorta supplying blood to the abdominal cavity. It begins at the aortic hiatus at the level of the T12 vertebra in the diaphragm, and ends approximately 15 cm inferior with the aortic bifurcation at the level of the L4 vertebra, at which location the width of the aorta is approximately 2-3 centimeters.
  • the arteries supplying the abdominal organs arise from the abdominal aorta in branches being visceral (pertaining to the internal organs) or parietal (relating to the walls of the abdominal cavity), and paired or unpaired.
  • the paired parietal inferior phrenic arteries stem from the abdominal aorta at T12 and supply the inferior surface of the diaphragm.
  • the visceral celiac trunk is unpaired and also emerges at T12. It divides into three branches (left gastric, splenic and common hepatic arteries) and supplies the stomach, liver, pancreas, spleen and a part of the small intestine.
  • the visceral, unpaired superior mesenteric artery arises which supplies a large part of the intestines.
  • the visceral suprarenal arteries are paired, located at LI and supplies the adrenal glands above the kidneys.
  • the visceral renal arteries emerge. They are paired and supply the kidneys.
  • the paired visceral gonadal arteries arise at L2 and extend into the scrotum in males, and pelvis in females.
  • the visceral inferior mesenteric artery is located, which is unpaired and the final major branch of the abdominal aorta.
  • the parietal lumbar arteries arise horizontally in four pairs from the lumbar region (the region pertaining to the abdominal section between the diaphragm and torso) of the aorta and support the abdominal wall.
  • the abdominal aorta splits into the common iliac arteries which supply the inferior part of the abdominal wall as well as the pelvis and lower limbs.
  • the median sacral artery emerges from the most inferior part of the abdominal aorta. It is unpaired and supplies the sacrum and coccyx.
  • the existing treatments include a surgical procedure in which a tube-like sleeve is implanted from the groin of the patient.
  • the sleeve acts as an artificial artery and is placed at the site of the aneurysm where it allows the blood flow to by-pass the aneurysm.
  • This method however has the drawback of embolism possibly forming due to the introduction of alien material in the bloodstream.
  • an implantable system for handling an aneurysm in a blood vessel of a patient comprises at least one adjustable vessel member configured for at least partially contacting a portion of the aorta at the aortic arch of the patient.
  • the system further comprises an implantable operation device for post-operatively adjusting the at least one adjustable vessel member.
  • the aortic arch has a curvature in the direction of the length extension of the aorta, and the at least one adjustable vessel member comprises an inner surface configured to face an outer surface of the aorta.
  • the inner surface of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension of the aorta, such that the inner surface follows the curvature of the aortic arch, and/or, the inner surface of the at least one adjustable vessel member comprises at least a first and a second portion, the first and second portions are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension of the aorta.
  • the adjustable vessel member has an inner portion and an outer portion.
  • the inner portion is configured to be placed proximal to the heart of the patient and the outer portion is configured to be placed distal to the heart of the patient.
  • the inner portion has an inner length in the direction of the length extension of the aorta
  • the outer portion has an outer length in the direction of the length extension of the aorta.
  • the outer length is longer than the inner length.
  • the outer length may be at least 1,2 times the length of the inner length, or at least 1,4 times the length of the inner length, or at least 1,6 times the length of the inner length, or at least 2 times the length of the inner length.
  • the outer length is at least 2 mm and the inner length is at least 4 mm. According to one embodiment, the outer length is at least 3 mm and the inner length is at least 6 mm.
  • the adjustable vessel member may comprise a first part comprising the inner portion and a second part comprising the outer portion, and the first and second parts may be adapted to be connected to each other to form at least a portion of the adjustable vessel member.
  • at least one portion of the adjustable vessel member formed by the connection of the first and second parts is adapted to enclose a portion of the aorta at the aortic arch of the patient.
  • the first and second parts are adapted to be connected to each other such that the joint between the first and second parts is more parallel than perpendicular to the direction of the blood flow.
  • the inner surface of the vessel member comprises a first curvature configured to follow the curvature of the aortic arch in the direction of the length extension of the aorta, and a second curvature configured to follow a curvature of the circumference of the aorta, in a cross-sectional plane perpendicular to the length extension of the aorta.
  • the first radius is in the range 12mm - 45mm, preferably in the range 15mm - 40mm, and more preferably in the range 20mm - 40mm.
  • a third straight line extends on the inner surface of the first portion, and a fourth straight line extends on the inner surface of the second portion.
  • the third straight line is connected to the fourth straight line, the third straight line is angled with a second angle in relation to the fourth straight line, and the first angle is different from the second angle.
  • the first angle is smaller than the second angle.
  • the first angle is more than 3° smaller than the second angle, and according to one embodiment, the first angle is more than 5° smaller than the second angle.
  • the first straight line and the third straight line are configured to extend on opposite sides of the aorta.
  • the first and second segments forms a bent channel configured to be placed around at least a portion of the aorta in the region of the aortic arch.
  • the first segment comprises at least one recess and the second segment comprises at least one protrusion, and the first segment is connectable to the second segment by the at least one protrusion being placed in the at least one recess.
  • the adjustable vessel member further comprises a third segment configured to be connected to the second segment.
  • the first segment has a length in the range 3mm - 30mm and the second segment has a length in the range 3mm - 30mm, more preferably, the first segment has a length in the range 5mm - 20mm and the second segment has a length in the range 5mm - 20mm.
  • a first portion of the adjustable vessel member comprises a first enclosing cross-sectional area perpendicular to the direction of the length extension of the aorta, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the aorta.
  • a second portion of the adjustable vessel member comprises a second enclosing cross-sectional area perpendicular to the direction of the length extension of the aorta.
  • the second enclosing cross-sectional area is configured for at least partially enclosing a portion of the aorta, and the second enclosing cross-sectional area is larger than the first enclosing cross- sectional area.
  • the at least one opening or the at least one recess in positioned at a joint between two or more segments of the adjustable vessel member, or at a joint between two or more parts of the adjustable vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
  • the adjustable vessel member can be at least partially opened for being introduced over the aorta for at least partially enclosing the aorta.
  • the adjustable vessel member comprises at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the aorta for at least partially enclosing the aorta.
  • the adjustable vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other, or radially displaced at an angle in the range 20° - 120° in relation to each other.
  • the adjustable vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other, or radially displaced at an angle in the range 20° - 120° in relation to each other.
  • the first and second segments comprises the recess for accommodating the blood vessel connected to the aorta.
  • the first and second segments comprises a furrow.
  • the at least one opening or the at least one recess in positioned at a joint between two or more segments of the vessel member, or at a joint between two or more parts of the vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
  • the vessel member comprises at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the aorta.
  • the at least one branch supporting element may be configured to encircle a branching blood vessel.
  • the inner surface of the adjustable vessel member is configured to engage the outer surface of the aorta.
  • the inner surface of the adjustable vessel member may comprise at least one inflatable portion at least partially facing the outer surface of the aorta.
  • the adjustable vessel member may be adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
  • the inflatable portion is connected to a valve for controlling the flow of a fluid to and from the inflatable portion.
  • the first segment may comprise a first inflatable portion and the second segment may comprise a second inflatable portion.
  • the first inflatable portion may be connected to a first valve for controlling the flow of a fluid to and from the first inflatable portion and the second inflatable portion may be connected to a second valve for controlling the flow of a fluid to and from the second inflatable portion.
  • the implantable system further comprises a conduit for creating a fluid connection between the first and second inflatable portion.
  • the adjustable vessel member comprises an elastic material, and the vessel member may be adapted to exert a mechanical pressure by the elastic properties of the elastic material.
  • the first segment is configured to exert a first pressure on the aorta and the second segment is configured to exert a second pressure on the aorta, and wherein the first and second pressures are individually adjustable.
  • the adjustable vessel member may be configured to exert an adjustable pressure on the aorta, and the system may further comprise an implantable controller for adjusting the pressure exerted on the aorta by the adjustable vessel member.
  • the operation device in any of the embodiments herein may comprise a hydraulic operation device, and the implantable system may further comprise an expandable hydraulic reservoir.
  • the implantable system further comprises a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion via the fluid connection for adjusting the pressure exerted on the aorta from the inflatable member.
  • the pump may be connected to the controller such that the controller can control the operation of the pump.
  • the inner surface comprises a first curvature configured to follow the curvature of the curvature of the blood vessel in the direction of the length extension of the blood vessel, and a second curvature configured to follow a curvature of the circumference of the blood vessel, in a cross-sectional plane perpendicular to the length extension of the blood vessel.
  • the first radius is at least 2 times the second radius.
  • the distance between an edge of the at least one opening and the at least one branching blood vessel connected to the blood vessel is configured to be between 1mm and 10mm.
  • the at least one branch supporting element is configured to encircle a branching blood vessel.
  • the hydraulic operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area.
  • a sensor configured to sense a parameter related to strain in the implantable system is configured to sense a strain in the vessel member connected to the expansion of the aneurysm.
  • the physiological parameter could be related to the blood pressure of the patient.
  • the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
  • the implantable controller is configured to transmit information based on sensor input to a source external to the body of the patient. The transmission could be done wirelessly.
  • the soft tissue is muscle tissue, such as the right or left crus, the psoas minor, the psoas major, the quadratus lumborum, the transverse abdominal, the obliques, the iliacus or the diaphragm.
  • the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising connective tissue, ligaments or fibrous tissue.
  • the system may comprise a first attachment device for attaching the first segment to a first portion of the body of the patient and a second attachment device for attaching the second segment to a second portion of the body of the patient.
  • the implantable system according to any of the preceding embodiments could further comprise a remote unit connected to the vessel member.
  • a major portion of the remote unit could be configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
  • the remote unit could comprise at least a portion of the operation device.
  • the implantable system could further comprise a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
  • the vessel member could comprise at least part of the operation device, and the part of the operation device comprised in the vessel member could comprise a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel.
  • the receiving portion could be configured to receive a linear mechanical force, or a rotating mechanical force which may be transformed into a liner mechanical force.
  • the implantable system may further comprise a gear system configured to reduce the velocity and increase the force of the received mechanical force.
  • the portion of the operation device placed in the remote unit may comprise an electrical motor.
  • the portion of the operation device placed in the remote unit may further comprise a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
  • the portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel.
  • the transmission may comprise at least one hydraulic cylinder.
  • the remote unit may further comprise a hydraulic reservoir for holding a hydraulic fluid and may comprise an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
  • the implantable system could further comprise at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member.
  • the remote unit may comprise a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to engage a first tissue surface of the tissue portion.
  • the remote unit may further comprise a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion.
  • the first, second and third planes are parallel to each other, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
  • At least one of the first portion may be detachably connected to the connecting portion, and the second portion may be detachably connected to the connecting portion.
  • An implantable system for handling an aneurysm in a blood vessel of a patient comprising at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, and an implantable operation device for post-operatively adjusting the at least one adjustable vessel member.
  • the at least one adjustable vessel member may comprise at least one of an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
  • the at least one opening may comprise at least one through- hole for accommodating the at least one branching blood vessel connected to the blood vessel.
  • the through-hole may have a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2, preferably in the range 16mm2 - 80mm2.
  • the at least one opening comprises at least one slit for accommodating the at least one branching blood vessel.
  • the slit adapted to accommodate at least one branching blood vessel may extend substantially in the direction of the length extension of the blood vessel.
  • the slit adapted to accommodate at least one branching blood vessel may extend in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
  • the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm, preferably in the range 1mm - 5mm.
  • the adjustable vessel member may comprise at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
  • the vessel member of the implantable system comprises at least one furrow adapted to accommodate at least one branching blood vessel.
  • the furrow adapted to accommodate the at least one branching blood vessel may extend substantially in the direction of the length extension of the blood vessel, or may extend in a direction at an angle in relation to the direction of the length extension of the blood vessel, being an angle in the range 10° - 45°.
  • the recess extends on an inner surface of the adjustable vessel member, such that the recess accommodates the branching blood vessel between the adjustable vessel member and the blood vessel.
  • the adjustable vessel member may comprise at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other.
  • the adjustable vessel member comprises at least one recess connected to at least one opening, such that a branching blood vessel can extend in the recess and further through the opening.
  • the first segment may comprise a first portion configured to encircle the blood vessel and the second segment may comprise a second portion comprising the opening for accommodating the at least one branching blood vessel, and/or the recess for accommodating the at least one branching blood vessel.
  • the first and second segments may be adapted to be assembled such that the joint between the first and second segments is more perpendicular than parallel to the direction of the length extension of the blood vessel.
  • the first segment is displaced in relation to the second segment, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
  • the first and second segments comprises an opening, which may be a through hole and/or a slit.
  • the at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess may be radially displaced at an angle in relation to each other, in relation to the blood vessel, along a center axis of the blood vessel.
  • the angle may be an angle in the range 10° - 180°.
  • a first portion of the adjustable vessel member may comprise a first enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel
  • a second portion of the adjustable vessel member may comprise a second enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the second enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, and the second enclosing cross-sectional area is larger than the first enclosing cross-sectional area.
  • a first segment of the adjustable vessel member may comprise the first enclosing cross-sectional area
  • the second segment of the adjustable vessel member may comprise the second enclosing cross-sectional area
  • the third segment of the vessel member may comprise a third enclosing cross-sectional area.
  • the third enclosing cross-sectional area may be larger than the second enclosing cross- sectional area.
  • the at least one opening or the at least one recess in positioned at a joint between two or more segments of the adjustable vessel member, or at a joint between two or more parts of the adjustable vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
  • the adjustable vessel member can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
  • the adjustable vessel member may comprise at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
  • the adjustable vessel member comprises an inner surface configured to face an outer surface of the blood vessel.
  • the inner surface of the adjustable vessel member may comprise at least one curvature configured to be placed in the direction of the length extension of the blood vessel, such that the inner surface can follow a curvature of the blood vessel.
  • the adjustable vessel member comprises an inner surface configured to face an outer surface of the blood vessel.
  • the inner surface of the adjustable vessel member could comprises at least a first and a second portion, and the first and second portions could be angled relative to each other, such that the adjustable vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
  • the adjustable vessel member comprises an inner surface configured to face an outer surface of the blood vessel.
  • the inner surface of the adjustable vessel member comprises at least a first and a second portion, and the first and second portions are displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
  • the adjustable vessel member comprises a first part and a second part.
  • the first and second parts are adapted to be connected to each other to form at least a portion of the adjustable vessel member.
  • the first and second parts may be assembled such that the joint between the first and second parts is more parallel than perpendicular to the direction of the length extension of the blood vessel.
  • the first and second parts are adapted to be assembled such that the joint between the first and second parts is substantially parallel to the direction of the length extension of the blood vessel.
  • the inner surface of the vessel member comprises a first curvature configured to follow a curvature of the blood vessel in the direction of the length extension of the blood vessel, and a second curvature configured to follow a curvature of the circumference of the blood vessel, in a cross-sectional plane perpendicular to the length extension of the blood vessel.
  • the first curvature has a first radius
  • the second curvature has a second radius.
  • the first radius may be larger than the second radius.
  • the first radius is at least 2 times the second radius.
  • the first radius may be in the range 12mm - 45mm, or in the range 15mm - 40mm, or in the range 20mm - 40mm.
  • the second radius is in the range 3mm - 25mm, or in the range 4mm - 15mm, or in the range 6mm - 12mm.
  • a first straight line extends on the inner surface of the first portion, and a second straight line extends on the inner surface of the second portion.
  • the first straight line is connected to the second straight line, and the first straight line is angled with a first angle in relation to the second straight line.
  • the first angle may be is in the range 3° - 90°, or in the range 5° - 45°.
  • the operation device may comprise at least one valve for controlling the flow of a fluid to and from the inflatable portion.
  • the first segment may comprise a first inflatable portion and the second segment mat comprise a second inflatable portion.
  • the operation device may comprise a first valve for controlling the flow of a fluid to and from the first inflatable portion, and a second valve for controlling the flow of a fluid to and from the second inflatable portion.
  • the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising soft tissue.
  • the attachment device could comprise at least one elastic member for connecting to a region of the body comprising soft tissue, which could be multiple elastic members connected to different regions of the body comprising soft tissue.
  • the operation device comprises a mechanical operation device for mechanically adjusting the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and/or a pressure exerted by the vessel member on the blood vessel.
  • the adjustable vessel member comprises an enclosing cross- sectional area perpendicular to the direction of the length extension of the blood vessel, the enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel.
  • the adjustable vessel member is configured for adjusting at least one of the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and a pressure exerted by the vessel member on the blood vessel, by the adjustable vessel member altering the size of the enclosing cross-section area.
  • the adjustable vessel member comprises a cuff configured to encircle a portion of the blood vessel.
  • the inner circumference of the cuff forms the outer circumference of the enclosing cross-sectional area.
  • the adjustable vessel member is configured to alter the size of the enclosing cross-section area by altering the inner circumference of the cuff.
  • the adjustable vessel member comprises a first portion configured to be positioned such that an inner surface of the first portion faces a first portion of the outside of the blood vessel, and a second portion configured to be positioned such that an inner surface of the second portion faces a second portion of the outside of the blood vessel.
  • the first and second portions are individually adjustable.
  • the implantable system further comprises an implantable controller for controlling the operation device.
  • the implantable controller may be configured to control the operation device to adjust the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and/or the pressure exerted by the vessel member on the blood vessel.
  • the implantable system further comprises at least one sensor configured to sense a connection between the inner surface of the vessel member and the outer surface of the blood vessel, and/or a pressure or force exerted by the blood vessel on the inner surface of the vessel member.
  • the implantable system further comprises at least one sensor configured to sense a parameter related to the expansion of the aneurysm.
  • the sensor configured to sense an expansion of the aneurysm may be a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
  • the sensor may be configured to sense at least one of: a pressure in an inflatable portion of the vessel member, a volume in an inflatable portion of the vessel member, a strain in the vessel member, an electrical connection or change in resistance, an optical change, and a temperature change.
  • the senor configured to sense a pressure may be configured to sense a pressure in at least one inflatable portion of the vessel member.
  • the inner surface of the vessel member comprises the sensor or is connected to the sensor.
  • the sensor may be connected to a hydraulic reservoir connected to the inflatable portion, and the sensor may be configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
  • the implantable system further comprises at least one sensor configured to sense at least one physiological parameter of the patient.
  • the physiological parameter of the patient could be one or more of: expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
  • the vessel member comprises an attachment device for attaching the vessel member to a portion of the body of the patient.
  • the attachment device may be configured to attach the vessel member to a portion of the body of the patient comprising bone.
  • the vessel member can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
  • the adjustable vessel member may thus comprise at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
  • the implantable system according to any one of the embodiments may comprise a vessel member having an inner surface comprising at least one curvature configured to be placed in the direction of the length extension of the blood vessel, such that the inner surface can follow a curvature of the blood vessel.
  • the inner surface of the vessel member comprises at least a first and a second portion being displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
  • the vessel member comprises a first part and a second part, and the first and second parts are adapted to be connected to each other to form at least a portion of the vessel member.
  • the first and second parts are adapted to be assembled such that the joint between the first and second parts is more parallel than perpendicular to the direction of the length extension of the blood vessel.
  • the vessel member comprises an opening for accommodating at least one branching blood vessel connected to the blood vessel, and/or a recess for accommodating at least one branching blood vessel connected to the blood vessel.
  • the at least one opening comprises at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel.
  • the through-hole has a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2, preferably in the range 16mm2 - 100mm2.
  • the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm.
  • the recess may comprise at least one furrow adapted to accommodate at least one branching blood vessel.
  • the implantable system further comprises a remote unit connected to the vessel member.
  • a major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
  • the remote unit comprises at least a portion of the operation device
  • the implantable system may further comprise a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
  • the vessel member comprises at least part of the operation device.
  • the part of the operation device comprised in the vessel member may comprise a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel.
  • the receiving portion is configured to receive a linear mechanical force and according to an alternative embodiment, the receiving portion is configured to receive a rotating mechanical force.
  • the transmission may be configured to transform the received rotating mechanical force into a liner mechanical force.
  • the transmission comprises a gear system configured to reduce the velocity and increase the force of the received mechanical force.
  • the portion of the operation device placed in the remote unit may comprise an electrical motor which may be connected to, or have an integrated gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
  • the portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel.
  • the transmission may comprise at least one hydraulic cylinder.
  • the portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
  • the portion of the operation device placed in the remote unit may comprise at least one hydraulic pump and may comprise a hydraulic reservoir for holding a hydraulic fluid and may comprise an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
  • the remote unit may further comprise an energy storage unit for directly or indirectly energizing the implantable system.
  • the remote unit may further comprise the implantable controller and the implantable controller may comprise a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
  • the implantable system further comprises at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member.
  • the implantable system further comprises a housing configured to enclose the remote unit.
  • a first portion of the housing may be made from titanium and a second portion of the housing may be made from a ceramic material.
  • the portion of the housing made from a ceramic material may comprise at least one coil embedded in the ceramic material.
  • the remote unit comprises a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, and a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion.
  • the first, second and third planes are parallel to each other, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
  • the first portion may be detachably connected to the connecting portion, and the second portion may be detachably connected to the connecting portion.
  • a device for treating an aneurysm of a mammal patient comprises an operable implantable member adapted to be placed in connection with the blood vessel having the aneurysm.
  • the implantable member is adapted to partially enclose the circumference of the aneurysm in a cross section such that at least one branch arising from the artery is not enclosed by the implantable member.
  • an implantable member that is adapted to be placed in connection with an aneurysm located at the aorta.
  • the implantable member is Y -shaped, thus, enabling for a better fit at Y -shaped vessel portions such as the aorta bifurcation.
  • the implantable member may comprise at least two segments adapted to be assembled. Having multiple segments adapted to be assembled ensures that the aneurysm treating device is adaptable with respect to the size, placement of the aneurysm and number of branches. Each segment may have a height parallel to the direction of the blood flow being 0.1cm to 5cm.
  • two segments at least partially encloses different circumferences of the blood vessel. This allows for an aneurysm treating device that can be adapted according to the different circumferences of the aneurysm.
  • a plane of the inner surface of a first segment of the at least two segments is adapted to have a first angle in relation to the center axis
  • a plane of the inner surface of a second segment of the at least two segments is adapted to have a second angle in relation to the center axis, and the first and second angles are different.
  • the at least one bendable member is adapted to penetrate the at least two segments through slots located at the at least two segments.
  • the first portion comprises at least one recess and the second portion comprises at least one protrusion
  • the first and second portions are adapted to be connected to each other by the at least one protrusion being placed in the at least one recess.
  • the implantable member comprises at least one opening adapted to receive at least one branch arising from a blood vessel.
  • the distance between the opening and the at least one branch is between 0.1cm and 1cm.
  • the at least one opening is rectangular.
  • the at least one rectangular opening has a width perpendicular to the direction of the blood flow being 0.1cm to 1cm, and a height parallel to the direction of the blood flow being 0.1cm to 1cm.
  • the at least one rectangular opening has a width perpendicular to the direction of the blood flow being 0.1cm to 5cm, and a height parallel to the direction of the blood flow being 0.1cm to 5cm.
  • the at least one opening is a flexible slit.
  • the implantable member is adapted to exert a pressure on the aneurysm. By applying a pressure, the aneurysm is kept from bursting.
  • the implantable member is adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
  • the device further comprises an implantable pump for increasing the pressure of a hydraulic fluid.
  • the implantable member is connected to a valve.
  • Fig. 5F shows a schematic, exploded view of a vessel member according to one embodiment.
  • Fig. 9E shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
  • Fig. 10B shows a schematic, cross-sectional view of a vessel member when it is placed on a blood vessel having an aneurysm.
  • Fig. 18A shows a lateral view of a patient’s thorax when a vessel member has been placed on the aorta at the aortic arch and fixated to the posterior side of the sternum.
  • Fig. 19A shows a schematic view of a patient’s aortic arch, when a vessel member comprised of three separate parts has been placed around the aorta at the artic arch.
  • Fig. 19 shows a schematic view of a patient’s aortic arch, when a vessel member comprised of three separate parts have been placed around the aorta at the artic arch.
  • Fig. 20B shows a schematic cross-sectional view of a vessel member or a segment of a vessel member.
  • Fig. 26B shows a cross-sectional view of an implantable remote unit for powering a vessel member with hydraulic force.
  • Fig. 28A shows a detailed cross-sectional view of a first unit of an implantable remote unit for powering a vessel member with hydraulic force.
  • Fig. 28D shows a detailed cross-sectional view of a first unit of an implantable remote unit for powering a vessel member with hydraulic force.
  • Figs. 29A - 3 IB shows alternative embodiments of connecting portions for an implantable remote unit.
  • Fig. 32 shows, schematically, a kit of components forming an implantable remote unit.
  • Fig. 34 shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 35 shows a perspective elevated view from the right of a portion of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 37A shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 37C shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 37D shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 38A shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 39 shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
  • Figs. 43A - 43C illustrates three stages of insertion and fixation of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 44 shows a detailed cross-sectional view of an embodiment of an implantable remote unit for powering an implantable system.
  • Fig. 45A shows, schematically, a portion of an implantable remote unit for powering an implantable system.
  • Fig. 45B shows, schematically, a portion of an implantable remote unit for powering an implantable system.
  • Fig. 46A shows a plain view of an embodiment of a hydraulic pump for operating an implantable medical device.
  • Fig. 46B shows a side view of the hydraulic pump of fig. 46A, for operating an implantable vessel member.
  • Fig. 46C shows a plain view of an embodiment of a hydraulic pump for operating an implantable medical device.
  • Fig. 47A shows a top view of a gear system for an implantable system.
  • Fig. 47B shows a partially sectional side view of a gear system for an implantable system.
  • Fig. 48 shows a sectional side view of an embodiment of a hydraulic pump for an implantable medical device.
  • Fig. 49A shows a sectional side view of an embodiment of a hydraulic pump for an implantable system.
  • Fig. 49D shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
  • Fig. 49E shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
  • Fig. 50 shows an elevated perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
  • Fig. 5 IB shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
  • Fig. 5 IE shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
  • Fig. 52 shows an overview of a system for handling an aneurysm on a blood vessel of a patient, including an electrode arrangement for electrical stimulation of a tissue portion of the blood vessel.
  • Fig. 53A shows an embodiment of an electrode arrangement, for inclusion in an implantable system.
  • Fig. 54 shows an embodiment of a stimulation cycle for electrical stimulation of a tissue wall.
  • Fig. 56 is a block diagram schematically describing the function of the system for electrical stimulation of a tissue wall of the patient.
  • Figs. 57A - 57N show embodiments and describes various functions of an implantable controller for controlling the implantable system and external devices used for control and communication with the implantable system for handling an aneurysm of the patient.
  • Fig. 570 shows an elevated perspective view from the left of a housing unit.
  • Fig. 57P shows a plain view from the left of a housing unit.
  • Fig. 57Q shows an elevated perspective view from the left of a housing unit.
  • Fig. 57R shows a plain view from the left of a housing unit.
  • Figs. 58A - 58C describes the reaction that takes place when a blood vessel is damaged.
  • Fig. 59 shows an implantable medical device comprising an implant surface and a coating arranged on the surface.
  • the arteries supplying the organs of the thorax arise from the thoracic aorta TA in branches. If the thoracic aorta TA is travelled from the heart, the illustrated branch most proximal to the heart is the Brachiocephalic artery 29, which is placed at the aortic arch 30 and bifurcates into the right carotid artery 29” which supplies the head and neck, and the right subclavian artery 29’ which supplies the right arm.
  • the next branch is the left common Carotid artery 28 which is also placed at the aortic arch 30 and also supplies the head and neck.
  • the left Subclavian artery 27, also placed at the aortic arch 30 supplies the left arm.
  • the aorta 20 then continues downward as the abdominal aorta AA (or abdominal portion of the aorta) from the diaphragm D to the aortic bifurcation 2.
  • the abdominal aorta AA is the part of the aorta 20 supplying blood to the abdominal cavity. It begins at the aortic hiatus 32, which is the orifice in the diaphragm D through which the aorta 20 travels between the thorax and the abdomen, at the level of the T12 vertebra 15.
  • the vessel member 100 comprises several segments 120a - 120e assembled along the direction of the length extension LE of the aorta 20, and the connection/attachment device 650 is in this embodiment fixedly connected to one of the segments 120c, which in turn connects to and stabilizes the segments, directly connecting to segment 120c, 120e and indirectly connecting to segments 120a and 120b.
  • the connection/attachment device 650 branches off into several attachment devices, each connecting to a segment of the vessel member, such as for example shown in figs. 15A,19A,24B.
  • the vessel member consists of only one segment, such as shown in for example figs. 8 - 9D.
  • the vessel member 100 could be placed at other blood vessels, such as the gastric, renal, iliac and brachial vessels.
  • the vessel member may be placed at other locations of the aorta, such as the aorta bifurcation 2, in which case the implantable member is Y -shaped, such as described in fig. 8B or at the aortic arch such as described with reference to figs. 18A - 23B in which case the vessel member is suitably adapted.
  • the first segment 120a of the vessel member 100 comprises a first enclosing cross-sectional area 126a perpendicular to the direction of the length extension LE of the blood vessel, for enclosing one portion of the blood vessel
  • the second segment 120b of the vessel member 100 comprises a second enclosing cross-sectional area 126b perpendicular to the direction of the length extension LE of the aorta, for enclosing another portion of the blood vessel.
  • the first and second segments 120A,120B are adapted to be assembled such that the joint between the first and second segments 120A,120B is more perpendicular than parallel to the direction of the length extension LE of the blood vessel, and in fig. 4A the joint between the first and second segments 120A,120B is substantially perpendicular to the direction of the length extension LE of the blood vessel.
  • Fig. 4B shows a vessel member 100 in an embodiment similar to the embodiment shown in fig. 4A, with the difference that the second segment 120b in fig. 4B comprises a first and second part 127a, 127b adapted to be connected to each other to enclose a portion of the blood vessel.
  • the first and second parts 127a, 127b are adapted to be connected to each other such that the joint between the first and second parts (127a, 127b) is substantially parallel to the direction of the length extension LE of the blood vessel and to the direction of the blood flow.
  • the second segment 120b in fig. 4B comprises a first and second part 127a, 127b adapted to be connected to each other to enclose a portion of the blood vessel.
  • the first and second parts 127a, 127b are adapted to be connected to each other such that the joint between the first and second parts (127a, 127b) is substantially parallel to the direction of the length extension LE of the blood vessel and to the direction of the blood flow.
  • Fig. 4C shows a vessel member 100 in an embodiment similar to the embodiment shown in fig. 4A, with the difference that the first segment 120a can be partially opened for being introduced over the blood vessel.
  • the first segment 120a in the embodiment of fig. 4C comprises at least one pivot joint 130 for enabling the segment 120a to be partially opened for being introduced over the blood vessel.
  • the pivot joint comprises an elastic material, such as a biocompatible silicone or polyurethane material. It is however equally conceivable that the joint comprises a hinge-like structure.
  • a first curvature cl having a first radius rl is configured to follow a curvature of the aorta 20 in the direction of the length extension LE of the aorta 20, and a second curvature c2 is configured to follow a curvature of the circumference of the aorta 20, in a cross-sectional plane perpendicular to the length extension LE of the aorta 20.
  • the first radius rl is larger than the second radius r2, more specifically, the first radius rl is more than 2 times the second radius r2.
  • the first radius rl is in the range 12mm - 45mm, more specifically in the range 15mm - 40mm, and even more specifically in the range 20mm - 40mm.
  • the second radius r2 is in the range 3mm - 25mm, more specifically in the range 4mm - 15mm, and even more specifically in the range 6mm - 12mm.
  • the opening 110 has a cross sectional area 129, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
  • the first, upper segment 120a is configured to completely encircle a first portion of the aorta
  • the second, lower segment 120b is configured to only partially encircle the aorta 20
  • the lower segment 120b comprises an opening 110 configured to accommodate at least one branching blood vessel.
  • the opening in fig. 5A is in the form of the second, lower segment 120b having a discontinuous circumference such that a square-shaped opening 100 is formed in the lower segment 120b of the vessel member 100.
  • the distance dl between an edge of the at least one opening 110 and the at least one branching blood vessel 1 connected to the aorta 20 is between 1mm and 10mm, more specifically between 2mm and 7 mm.
  • Fig. 5B shows an embodiment of the vessel member 100 similar to the embodiment shown in fig. 5A, the difference being that in the embodiment of fig. 5B, the vessel member further comprises a third segment 120c comprising a third connection interface 125c, in the form of a upwards facing connection recess, configured to mate with a downwards facing connection protrusion of the second segment 120b.
  • the first, second and third segments 120a, 120b, 120c
  • the first, second and third segments can be connected to each other for creating the vessel member 100 configured to follow the shape of the aneurysm 50 of the aorta 20 in the direction of the length extension LE of the aorta.
  • the first segment 120a of the vessel member 100 is configured to completely encircle the aorta
  • the second segment 120b comprises the opening 110 for accommodating at least one branching blood vessel 1 connected to the aorta 20
  • the third segment 120c of the vessel member 100 is configured to completely encircle the aorta 20.
  • the uppermost portions of each of the first, second and third segments 120a, 120b, 120c each comprises an enclosing cross-sectional area 126a, 126b, 126c configured for the cross-sectional area of the aorta 20 at that particular portion. In the embodiment shown in fig.
  • the second enclosing cross-sectional 126b area is larger than the first enclosing cross-sectional area 126a and the third enclosing cross-sectional 126c area is larger than the second enclosing cross-sectional area 126b, and as such the vessel member 100 is adapted for enclosing an aneurysm having an increasing diameter or cross-sectional area.
  • Fig. 5C shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5B.
  • the difference in relation to the embodiment shown in fig. 5B is that the opening 110 in fig. 5 C is an annular though-hole which has a larger cross-sectional area than the square-shaped opening in the segment of fig. 5B.
  • the opening 110 has a cross sectional area 129, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
  • the distance d2 between the annular edge of the through-hole and the branching blood vessel 1 connected to the aorta 20 is between 3mm and 10mm and the diameter of the annular through hole is in the range 8mm - 22mm, more specifically in the range 10mm - 18mm, i.e. the annular though-hole has a cross sectional area 129, in a plane perpendicular to the radius of the aorta 20, in the range 50mm2 - 380mm2, more specifically in the range 78mm2 - 254mm2.
  • the opening could have an equal cross sectional area but have a different shape, such as an oval or square shape.
  • the opening is comprised in the first, second and third segments 120a, 120b, 120c. In alternative embodiments it is however conceivable that the opening is comprised in only two segments, such as in the first and second segment, or in the second and third segments.
  • Fig. 5D shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5C.
  • the vessel member additionally comprises a fourth and fifth segment 120d,120e, where the fourth segment 120d is connectable to the third segment 120c in the same way as the first, second and third segments 120a, 120b, 120c are connected, and the fifth segment 120e is connectable to the fourth segment 120d in the same way.
  • the second enclosing cross- sectional area 126b is larger than the first enclosing cross-sectional area 126a
  • the third enclosing cross-sectional area 126c is larger than the second enclosing cross-sectional area 126b
  • the fourth enclosing cross-sectional area 126d has the same size as the third enclosing cross-sectional area 126c
  • the fifth enclosing cross-sectional area 126e is smaller than the fourth enclosing cross- sectional area 126d.
  • the first, second, fourth and fifth segments 120a, 120b, 120d,120e all have the shape of a conical frustum
  • the third segment 120c has a cylindrical shape.
  • the second segment 120b comprises a first opening 110a for accommodating a first branching blood vessel 1’ connected to the aorta 20
  • the fourth segment 120d comprises a second opening 110b for accommodating a second branching blood vessel 1” connected to the aorta 20.
  • the two openings 110a, 110b are radially displaced at an angle in the range 10° - 180° in relation to each other, more specifically at an angle in the range 30° - 90° in relation to each other.
  • Fig. 5E shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5C.
  • the first and third segments 120a, 120c are longer in the direction of the length extension LE of the aorta 20.
  • the first segment 120a has a length LI in the direction of the length extension LE of the aorta 20
  • the second segment 120b has a length L2 in the direction of the length extension LE of the aorta
  • the third segment 120c has a length L3 in the direction of the length extension LE of the aorta 20.
  • the first and third lengths L1,L3 are both more than two times the length of the second length L2.
  • the inner surface 121a of the first segment 120a has a first curvature cl in the direction of the length extension LE of the aorta, adapted to correspond to an upper portion of an aneurysm 50, for enabling the vessel member 100 to follow the contour of the aneurysm 50.
  • the inner surface 121b of the second segment 120b has a second curvature c2 in the direction of the length extension LE of the aorta, adapted to correspond to a middle portion of an aneurysm 50, for enabling the vessel member 100 to follow the contour of the aneurysm 50
  • the inner surface 121c of the third segment 120c has a third curvature c3 in the direction of the length extension LE of the aorta, adapted to correspond to a lower portion of the aneurysm 50, for enabling the vessel member 100 to follow the contour of the aneurysm 50.
  • the first curvature cl has a first radius rl
  • the second curvature c2 has a second radius r2.
  • the second radius r2 is larger than the first radius rl, in particular, the second r2 is at least 2 times the first radius rl.
  • the first radius rl is in the range 10mm - 80mm, more specifically in the range 10mm - 60mm, and even more specifically in the range 20mm - 60mm.
  • the second radius r2 is in the range 30mm - 200mm, more specifically in the range 40mm - 150mm, and even more specifically in the range 50mm - 100mm.
  • the third curvature c3 has a third radius r3 being the same as the first radius rl.
  • the most upper portion of the first segment 120a of the vessel member 100 comprises a first enclosing cross-sectional area 126a
  • the lower most portion of the vessel member 100 comprises a second enclosing cross-sectional area 126b
  • the second enclosing cross-sectional area 126b is larger than the first enclosing cross-sectional area 126a such that the first segment 120a can accommodate the upper portion of a bulging aneurysm 50 on the aorta 20.
  • each of the annular openings 110a, 110b, 110c are positioned at the joints and as such, the connecting surfaces 128’ are placed on two sides of the respective openings 110a, 110b, 110c.
  • the segments 120a - 120e can be radially rotated in relation to each other, to adapt the rotational orientation of the openings 110a - 110c to the branching vessels, and as such the annular openings can be radially displaced in relation to each other, or aligned, all depending on the specific anatomy of the blood vessel at which the vessel member 100 is placed.
  • Fig. 6A shows an embodiment of a vessel member 100 in which the vessel member 100 comprises an opening 110 in the form of a slit extending in the direction of the length extension LE of the blood vessel BV.
  • the slit 110 is adapted for accommodating the at least one branching blood vessel 1 connected to the blood vessel BV.
  • the vessel member comprises a first enclosing cross- sectional area 126a perpendicular to the direction of the length extension LE of the blood vessel BV, placed at the upper most portion of the vessel member 100.
  • the first enclosing cross-sectional area 126a is configured for completely enclosing a portion of the blood vessel BV.
  • a second, central portion of the vessel member 100 comprises a second enclosing cross-sectional area 126b perpendicular to the direction of the length extension LE of the blood vessel BV.
  • the second enclosing cross-sectional area 126b has a larger area than the first enclosing cross-sectional area 126a, such that the vessel member 100 is adapted for a bulging aneurysm on the blood vessel BV.
  • any of the vessel members shown herein may have a first enclosing cross-sectional area having an area which is less than 0,9 times as large as an area of a second enclosing cross-sectional area.
  • any of the vessel members shown herein may have a first enclosing cross-sectional area having an area which is less than 0,8 times as large as an area of a second enclosing cross-sectional area, and even more preferably, any of the vessel members shown herein may have a first enclosing cross-sectional area having an area which is less than 0,6 times as large as an area of a second enclosing cross-sectional area.
  • Fig. 6B shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 6A, with the difference that the embodiment of fig. 6B, the slit 110 is adapted to accommodate two branching blood vessels 1’, 1” which are both radially and axially displaced in relation to each other.
  • the slit 110 is elongated and extends in a direction at an angle a in relation to the direction of the length extension LE of the blood vessel BV in the range 10° - 45°.
  • the two branching blood vessels l’,l” are radially displaced at an angle in the range 10° - 50° in relation to each other, more specifically at an angle in the range 10° - 30° in relation to each other.
  • each of the parts 140a - 140d comprises a connection recess 125, in the form of a groove extending in a direction parallel to the length extension LE of the blood vessel, and each of the parts comprises a connection protrusion 124, in the form of a an elastic tongue extending in a direction parallel to the length extension LE of the blood vessel and being configured to be placed in the groove for creating an interconnection between two parts for forming a portion of the vessel member 100.
  • the connected vessel member comprises three openings 110a, 110b, 110c each of which being configured to accommodate a branching blood vessel.
  • the openings 110a, 110b, 110c are positioned at the joints between the parts, such that both parts comprise a portion of the opening. This enables the parts to be placed around the branches when putting the vessel member 100 into place.
  • the upper most portion of the vessel member 100 of fig. 7A comprises a first enclosing cross-sectional area 126a, and a central portion of the vessel member 100, in the center of the openings 110a, 110b, 110c comprises a second enclosing cross-sectional area 126b.
  • the first enclosing cross-sectional area 126a is configured to completely encircle a first portion of the blood vessel
  • the second enclosing cross-sectional area 126b is configured to only partially encircle the blood vessel, as the second enclosing cross- sectional area 126b comprises the openings 110a, 110b, 110c, each configured to accommodate at least one branching blood vessel.
  • the second enclosing cross-sectional area 126b has a larger area than the first enclosing cross-sectional area 126a, such that the vessel member 100 is adapted for a bulging aneurysm on the blood vessel.
  • connection between the connecting protrusion 124 and the connecting recess 125 is locked by means of a locking member 132 insertable inside of the horseshoe-shaped cross-section, such that the connecting protrusion 124 is locked in the connecting recess 125 without the ability of being removed from the connecting recess 125.
  • the branch supporting elements 134’, 134 extends a distance in the range 1mm - 10mm from the outer surface of the vessel member 100, in a substantially radial direction in relation to the length extension LE of the blood vessel BV.
  • the branch supporting elements 134’, 134 are materially integrated with the vessel member 100, i.e. they are made from the same material as the vessel member.
  • the branch supporting elements 134’, 134” could be made from a different material and could be separate from the vessel member 100.
  • Fig. 8B shows an embodiment of the vessel member 100 configured to be placed at the aorta bifurcation 2.
  • the vessel member 100 is made like a three-way channel comprising a first main entry 119a aligned with the length extension LE of the aorta 20 and directed in the cranial direction.
  • the three-way channel further comprises a second and third entry 191b, 191c aligned with a second and third length axis LE’,LE” respectively.
  • the vessel member of the embodiment of fig. 8B further comprises an opening 110 for accommodating a branching blood vessel 1.
  • Fig. 9A shows an embodiment of the vessel member 100 in which the vessel member 100 comprises a recess 150 in the form of a furrow 150 adapted to accommodate a branching blood vessel 1.
  • the furrow 150 extends substantially in the direction of the length extension LE of the blood vessel BV and is in the embodiment shown in fig. 9A made by the vessel member 100 being shaped with a protruding portion 151 on the outer surface, which houses the recess 150 extending in the inner surface of the vessel member 100, such that the recess 150 accommodates the branching blood vessel 1 between the vessel member 100 and the blood vessel BV.
  • the vessel member 100 comprises a recess 150 in the form of a furrow 150 adapted to accommodate a branching blood vessel 1.
  • the furrow 150 extends substantially in the direction of the length extension LE of the blood vessel BV and is in the embodiment shown in fig. 9A made by the vessel member 100 being shaped with a protruding portion 151 on the outer surface, which houses the recess 150 extending in the
  • the recesses 150’, 150 extends along the entire length of the vessel member 100, parallel to the length extension LE of the blood vessel BV. In alternative embodiment it is however equally conceivable that one or both of the recesses extends only along a portion of the length of the vessel member 100. In the embodiment shown in fig.
  • the branching blood vessels 1 ’, 1 connects to the blood vessel BV in the same plane perpendicular to the length axis of the blood vessel BV. I.e. at the same vertical height in relation to the illustration of fig. 9C.
  • the branching blood vessels connect to the blood vessel BV at different heights and that the recesses are correspondingly adapted.
  • Fig. 9D shows an embodiment of the vessel member 100 similar to that shown in fig. 9A, with the difference that in the embodiment shown in fig. 9D a combination of a recess 150 and an opening 110 is shown.
  • the recess 150 in the form of a furrow 150 is connected to the opening 110, such that a branching blood vessel 1 can extend in the recess 150 and further through the opening 110.
  • the combination of recesses and openings enables the adaptation of the vessel member 100 to the anatomy of the blood vessel BV and the branching vessels, as well as a slight alteration of the path that such branching blood vessels.
  • the opening is an annular opening in the form of a through-hole, however in alternative embodiments the opening may be an opening according to any one of the embodiments of openings described herein.
  • the vessel member could in alternative embodiments comprise more than one recess and/or more than one opening.
  • Fig. 9E shows an embodiment of the vessel member 100 similar to that shown in fig. 9A, with the difference that in the embodiment shown in fig. 9E, the vessel member 100 comprises a first and second segment 120a, 120b (the features of which being similar to the embodiment disclosed with reference to fig. 4A).
  • the first and second segments 120a, 120b each comprises a portion of the recess 150 for accommodating the branching blood vessel 1, such that the joint between the first and second segments 120a, 120b passes the recess 150.
  • Fig. 9F shows an embodiment of the vessel member 100 similar to a combination of the embodiments shown in figs. 9C and 9E.
  • the vessel member 100 comprises a first and second segment 120a, 120b each comprising a recess 150’, 150” for accommodating a first and a second the branching blood vessel 1 ’, 1 ” .
  • the first and second recesses 150’, 150” are not connected to each other, rather, on the contrary, the first and second recesses 150’, 150” are radially displaced at an angle P in relation to each other, relative to the length extension LE of the blood vessel BV.
  • the embodiment of fig 10B shows two angled portions being parts of two different segments, a first and a second segment 120a, 120b, being configured to be connected for forming a connected vessel member 100.
  • the two portions are just two portions of the same, materially integrated, vessel member. I.e. a single segment having a first and a second portion being angled in relation to each other.
  • the second segment 120b is a cylindrical segment, while the first segment is a segment having a varying angle in relation to the second segment.
  • a second axis A2 in the form of a second straight line on the second inner surface 121b of the second segment 120b, extending on an axial plane AP intersecting the length extension LE of the blood vessel BV, which is parallel to the length extension LE of the blood vessel BV.
  • a first axis Al in the form of a first straight line on the first inner surface 121a of the first segment 120a extends on the axial plane AP intersecting the length extension LE of the blood vessel BV.
  • the first and second axis A1,A2 are connected and there is an angle P between the first and second axis A1,A2.
  • the first straight line and the third straight line, i.e. following the first and third axis Al, A3 are configured to extend on opposite sides of the blood vessel BV, i.e. the first and third axis Al, A3 are radially displaced in relation to the length extension LE of the blood vessel BV with 180°.
  • Fig. 12 shows a schematic illustration of an embodiment of a vessel member 100, similar to the embodiment described with reference to fig.l 1.
  • the vessel member 100 comprises a first and second portion/segment 120a, 120b, each having an inner surface 12 la, 12 lb.
  • the inner surface 121a of the first portion/segment 120a has a first curvature Cl with a radius Rl
  • the inner surface 121b of the second portion/segment 120b has a second curvature C2 with a radius R2.
  • the first and second curvatures C1,C2 enables the vessel member 100 to follow the curvature of the blood vessel BV.
  • Fig. 13A - 13C shows the vessel member according to the embodiment further described with reference to fig. 5D, when the third segment 120c of the vessel member is fixated to an attachment device 182 for attaching the vessel member to a portion of the body of the patient, more specifically in the embodiments of figs. 13A - 13C to a portion of the body of the patient comprising bone, and even more specifically in the embodiment of figs. 13A - 13C, to the spine of the patient.
  • the vessel member may be configured to be placed at a distance from the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel. As such, the vessel member does not risk damaging the blood vessel in situations in which connection between the vessel member and the blood vessel is not needed.
  • the distance between the vessel member and the blood vessel could be the distance between the blood vessel and a hydraulic cuff positioned on the inner surface of the vessel member, and this distance may be adjusted by adjusting the amount of hydraulic fluid in the hydraulic cuff 601a - 601e.
  • Fig. 15B is a cross sectional view of the fifth segment 120e in which it is shown in further detail how the conduit 15 le enters through the supporting structure 602 of the fifth segment and into the hydraulic cuff 601 such that a fluid connection between the conduit 15 le and the hydraulic cuff 601 is created.
  • the hydraulic cuff 601 in the embodiment shown in fig. 15B is made from a biocompatible elastomeric polymer material, such as a silicone or polyurethane based polymer material.
  • the conduit is integrated in the hydraulic cuff and as such made from essentially the same biocompatible elastomeric polymer material such that a material integration is created which reduces the risk of leakage.
  • the vessel member is an adjustable vessel member, and more particularly, a hydraulically adjustable vessel member.
  • the first part 140a comprises a first adjustable hydraulic element 601a and the second part 140b comprises a second hydraulic element 601b.
  • the parts of the vessel member 140a - 140d forms a kit, such that the connected vessel member 100 can be formed by connecting two parts from the kit of parts.
  • the connected vessel member 100 has a periphery P surrounding the blood vessel when implanted.
  • the kit comprises a first, second, third and fourth parts 140a, 140b, 140c, 140d.
  • the second, third and fourth parts 140b, 140c, 140d are all configured to be connected to the first part 140a for forming the connected vessel member 100.
  • the connected vessel member 100 can be made to match the particular blood vessel having the aneurysm of the particular patient.
  • the first part 140a comprises a first operable hydraulic element 601a configured to be inflated with a hydraulic fluid entering the first operable hydraulic element 601a through a first hydraulic fluid conduit 65 la via a tubing fixation portion 655a.
  • the second, third and fourth parts 140b, 140c, 140d all comprise a second operable hydraulic element 601b configured to be inflated with a hydraulic fluid entering the second operable hydraulic element 601b through a second hydraulic fluid conduit 651b via a tubing fixation portion 655b.
  • the first and second operable hydraulic elements 60 la, 60 lb may be connected to the same hydraulic system (hydraulic pump and/or valve) or may be connected to separate hydraulic systems.
  • the parts 140a - 140d are adapted to be assembled such that the joints between the parts 140a - 140d are substantially parallel to the direction of the length extension of the blood vessel to be enclosed by the connected vessel member 100.
  • the operable hydraulic elements faces the outer surface of the portion of the blood vessel enclosed by the connected vessel member 100.
  • the inner surfaces of the parts 140a, 140b together forms a circle with a radius Rl, i.e. the curvatures Ca,Cb of the circle has the radius Rl.
  • the curvatures Ca,Cb are configured to follow a curvature of the circumference of the blood vessel in a cross-sectional plane perpendicular to the length extension of the blood vessel.
  • the radius Rl is in the interval 3mm - 25mm, more specifically in the interval 4mm - 15mm, and even more specifically in the interval 6mm - 12mm.
  • third part 140c has an identical curvature and connecting portions 140c’, 140c” as the third part shown in fig. 16A.
  • the third part 140c of the embodiment shown in fig. 16B does not comprise an operable hydraulic element, instead the third part 140c comprises a cushioning element 630 configured to either contact or be placed at a distance from the blood vessel.
  • the cushioning element 630 is fixated to the inner surface of the third part 140c by means of an adhesive and is more resilient than the supporting structure 602 of the third part 140c.
  • the cushioning element 630 could be made from a medical grade silicone material and could be filled with a biocompatible gel which enables the cushioning element 630 to be shaped to suit the blood vessel which reduces the risk that the contact with the blood vessel damages the blood vessel.
  • the cushioning element 630 comprises a solid resilient material, such as a soft medical grade silicone of polyurethane material.
  • the aorta at the aortic arch 30 is a blood vessel having a substantially tube-shaped tissue having a length and an annular circumference in a cross-section perpendicular to the direction of the blood flow and perpendicular to the length extension of the aorta.
  • the implantable system of fig. 17 further comprises an implantable operation device placed in a remote unit 600 connected to the adjustable vessel member 100 for post-operatively adjusting the adjustable vessel member 100.
  • the connecting portion 642 connects the first and second portions 641 ’,641” though three layers of muscle tissue MT, namely tissue of the transverse abdominal muscle TM, the internal oblique muscle IM and the external oblique muscle EM.
  • the second portion 641 is placed in between layers of muscle, such as between tissue of the transverse abdominal muscle TM, the internal oblique muscle IM, or between the internal oblique muscle IM and the external oblique muscle EM.
  • the connecting portion 642 connects the first and second portions 641 ’,641” through two layers of muscle tissue MT, or through one layer of muscle tissue MT.
  • a major portion of the remote unit 600 is placed at a distance exceeding 80mm from a major portion of the adjustable vessel member 100, more specifically, a major portion of the remote unit 600 is placed at a distance exceeding 100mm from a major portion of the adjustable vessel member 100, even more specifically a major portion of the remote unit 600 is placed at a distance exceeding 140mm from a major portion of the adjustable vessel member 100, and even more specifically, a major portion of the remote unit 600 is placed at a distance exceeding 200mm from a major portion of the adjustable vessel member 100.
  • the embodiment shown in fig. 17 is a hydraulic embodiment in which the adjustable vessel member 100 is a hydraulically adjustable vessel member 100.
  • the hydraulically adjustable vessel member 100 is then operated by a hydraulic operation device comprising a hydraulic pump and optionally at least one hydraulic valve.
  • the hydraulic pump is placed in the remote unit 600 and as such, the remote unit 600 comprises at least a portion of the operation device and could for example be any of the hydraulic pumps 604 described with reference to figs. 46A - 50.
  • the remote unit 600 is connected to the adjustable vessel member via a connection/attachment device 650 comprising a hydraulic conduit for transferring force hydraulically from the remote unit 600 to the adjustable vessel member, for operating the adjustable vessel member.
  • the connection/attachment device 650 comprising a hydraulic conduit run between the peritoneum PT and the muscle tissue MT vertically until connection/attachment device 650 reaches the height of the major portion of the adjustable vessel member 100. At this height, the connection/attachment device 650 enters the peritoneum PT and travels substantially horizontally to the adjustable vessel member 100.
  • connection/attachment device 650 is placed inside of the intraperitoneal space for as short distance as possible which reduces the risk that implanted, foreign body elements disturb the intraperitoneal organs, reducing the risk of damage to organs, and reducing the risk that foreign body elements cause ileus.
  • the operation device also comprises at least one valve for controlling the flow of hydraulic fluid from the hydraulic pump to the adjustable vessel member 100
  • such valve may be placed in, or in close proximity to, the adjustable vessel member 100.
  • the adjustable vessel member 100 may comprise at least a part of the operation device. It may however also be so that at least one valve is placed in the remote unit 600, or that the operation device comprises valves in both the adjustable vessel member 100 and the remote unit 600.
  • connection/attachment device 650 further comprises at least one lead for transferring electrical energy and/or information from the remote unit 600 to the adjustable vessel member 100.
  • the information could be control signals to the adjustable vessel member 100 or sensor input or outer feedback from the adjustable vessel member 100 to the remote unit 600.
  • the operation device placed in the remote unit may comprise an electrical motor, which may be connected to a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
  • the implantable system may comprise a hydraulic/mechanical operation device in which a portion of the operation device is placed in the adjustable vessel member 100 and comprises a receiving portion configured to receive hydraulic force, such as described in relation to the embodiment shown in fig. 17.
  • the portion of the operation device is placed in the adjustable vessel member 100 could then further comprise a transmission for transforming the received hydraulic force into a mechanical force for exerting a pressure on the vessel.
  • Such transmission could for example be at least one hydraulic cylinder.
  • the adjustable vessel member could comprise bands comprising an elastic material, and the adjustable vessel member could be adapted to exert a mechanical pressure by the elastic properties of the elastic material.
  • Fig. 18A shows a lateral, sectional view of the heart H, the thoracic portion of the aorta 20, including the aortic arch 30, as well as the rib cage comprising the ribs R and the sternum S.
  • the vessel member 100 is in the embodiment of fig. 18A placed between the heart and the Brachiocephalic artery 29 at an area of an aneurysm on the aorta at the artic arch 30.
  • the vessel member 100 is fixated to an attachment device for attaching the vessel member 100 to a portion of the body of the patient, more specifically in the embodiment of fig. 18A to the sternum S of the patient.
  • the attachment device comprises an elongated distance element 185, connecting the vessel member 100 to a fixation plate 183 configured for fixation to the sternum S, on the posterior side thereof (inside).
  • the fixation plate 183 could be fixated to cortical bone of the sternum S with the use of orthopedic screws.
  • the elongated distance element 185 may be somewhat resilient for absorbing movements between the rib cage and the heart H created by the patient breathing.
  • Fig. 18B shows an embodiment similar to that of fig. 18A, the difference being that the elongated distance element 185 travels through a through-hole in the sternum S for fixation to a fixation plate 183 configured to be placed on the anterior side (outside) of the sternum S.
  • Fig. 18C shows an embodiment similar to that of fig. 18A, the difference being that the vessel member 100 comprises a first and second portion/segment 120a, 120b.
  • the first portion/segment 120a is fixated to a first elongated distance element 185a, connecting the first portion/segment 120a to a first fixation plate 183a configured for fixation to the sternum S, on the posterior side thereof (inside).
  • the second portion/segment 120b is fixated to a second elongated distance element 185b, connecting the second portion/segment 120b to a second fixation plate 183b configured for fixation to the sternum S, on the posterior side thereof (inside).
  • Fig. 18D shows an embodiment similar to that of fig. 18A, the difference being that the vessel member 100 comprises a first, second and third portion/segment 120a, 120b, 120c.
  • the first portion/segment 120a encircles the aorta 20 between the heart H and the Brachiocephalic artery 29
  • the second portion/segment 120b comprises an opening for accommodating the Brachiocephalic artery
  • the third portion/segment 120c encircles the aorta 20 between the Brachiocephalic artery 29 and the left common Carotid artery 28.
  • the first portion/segment 120a is fixated to an elongated distance element 185, connecting the first portion/segment 120a to a fixation plate 183 configured for fixation to the sternum S, on the posterior side thereof (inside).
  • the second portion/segment 120b is fixated to the first portion/segment and the third portion/segment is fixated to the second portion/segment.
  • the entire vessel member 100 is fixated by means of a single attachment device fixated to the first portion/segment 120a. I.e. the other segments of the vessel member 100 are attached to the sternum S indirectly by means their direct or indirect connection to the first segment 120a fixated with the attachment device to the sternum S.
  • Fig. 18E shows an embodiment similar to that of fig. 18A, the difference being that the elongated distance element 185 is fixated to a fixation plate 183 configured to be placed on the posterior side (inside) of a rib R.
  • the fixation plate 183 could be fixated to cortical bone of the rib R with the use of orthopedic screws.
  • the elongated distance element 185 may be somewhat resilient for absorbing movements between the rib cage and the heart H created by the patient breathing.
  • Fig. 19A shows an implantable system for handling an aneurysm in a blood vessel of a patient, when the system has been implanted in the body of the patient for handling an aneurysm at the aorta 20 of the patient, more specifically, at the aortic arch 30 of the patient.
  • the system comprises a vessel member 100, which is a hydraulically adjustable vessel member 100 positioned on the aorta 20 at the aortic arch 30 of the patient, in the thoracic portion of the aorta 20.
  • the vessel member 100 partially encloses the aorta 20 in a region of an aneurysman on the aortic arch 30.
  • the vessel member comprises a first, second and third segment 120a, 120b, 120c, being placed at different portions of the aortic arch 30.
  • Each of the first, second and third segment 120a, 120b, 120c comprises an enclosing cross-sectional area perpendicular to the direction of the length extension LE of the aorta 20, the enclosing cross- sectional area being configured for at least partially enclosing a portion of the aorta 20.
  • the distance between the inner surface of each of the segments 120a, 120b, 120c and the outer surface of the aorta 20, or the pressure exerted on the aorta by the segments of the adjustable vessel member 100 is altered by altering the size of the enclosing cross-section area.
  • the hydraulic operation device could be any of the hydraulic operation devices disclosed herein, and the hydraulic operation device could be controlled by an implantable controller according to any of the embodiments discloses herein, for adjusting the volume in the hydraulic cuffs, or pressure exerted by the hydraulic cuffs.
  • an implantable controller for adjusting the volume in the hydraulic cuffs, or pressure exerted by the hydraulic cuffs.
  • first, second and third segments 120a, 120b, 120c are individually connected to the hydraulic operation device(s), the pressure and/or amount of fluid in each of the first, second and third segments 120a, 120b, 120c can be individually adjusted.
  • the first segment 120a can exert a first pressure on the aorta 20
  • the second segment can exert a second pressure on the aorta 20
  • the third segment can exert a third pressure on the aorta 20.
  • the first segment 120a encircles the aorta 20 between the heart H and the Brachiocephalic artery 29, the second segment 120b encircles the aorta 20 between the Brachiocephalic artery 29, and the left common Carotid artery 28, and the third segment 120c encircles the aorta 20 after the left Subclavian artery 27, in the direction of the descending aorta.
  • the Brachiocephalic artery 29 can thus freely branch between the first and second segments 120a, 120b, and the left common Carotid artery 28 and the left Subclavian artery 27 can freely branch between the second segment 120b and the third segment 120c.
  • the first segment 120a has a width in the range 3mm - 15mm (in the direction of the length extension LE of the aorta 20), the second segment 120b has a width in the range 3mm - 10mm, and the third segment 120c has a width in the range 3mm - 20mm.
  • the aortic arch 30 has a curvature in the direction of the length extension LE of the aorta 20.
  • Each of the segments 120a, 120b, 120c of the adjustable vessel member 100 comprises an inner surface configured to face an outer surface of the aorta 20 and being adapted to accommodate the curvature in the direction of the length extension LE of the aorta 20.
  • Each of the segments 120a, 120b, 120c of the adjustable vessel member 100 could either be configured to be placed at a distance from the aorta, such that the inner surfaces of each of the segments 120a, 120b, 120c does not engage the outer surface of the aorta 20, or in the alternative, be configured to engage the outer surface of the aorta to exert a withholding force or pressure against the outer wall of the aorta, in a region of an expanding aneurysm on the aorta 20.
  • the adjustable vessel member 100 may be adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient, such that a counterforce can be exerted without risking hampering the blood flow and thereby the saturation of the tissue wall of the aorta.
  • the first, second and third segments 120a, 120b, 120c all comprises hydraulically inflatable cuffs for altering the distance between the inner surfaces of the segments and the outer surface of the aorta 20, or the pressure exerted on the outer surface of the aorta 20.
  • the first, second and third segments 120a, 120b, 120c of the vessel member comprises an elastic material and as such are capable of exerting a mechanical pressure on the outer surface of the aorta 20 by the elastic properties of the elastic material.
  • the first, second and third segments 120a, 120b, 120c of the vessel member comprises an elastic material and as such are capable of exerting a mechanical pressure on the outer surface of the aorta 20 by the elastic properties of the elastic material.
  • the first, second and third segments 120a, 120b, 120c of the vessel member comprises an elastic material and as such are capable of exerting a mechanical pressure on the outer surface of the aorta 20 by the elastic properties of the elastic material.
  • 120a, 120b, 120c of the vessel member each comprises mechanical operation devices for altering the distance between the inner surfaces of the segments 120a, 120b, 120c of the vessel member and the outer surface of the aorta 20, or the pressure exerted by the segments 120a, 120b, 120c on the outer surface of the aorta 20.
  • the mechanical operation devices could for example comprise electrical motors.
  • the vessel member 100 is a single vessel member 100 having a plurality of portions P1,P2,P3,P4,P5.
  • the portions are portions of the same single vessel member 100 and are materially integrated.
  • the single vessel member 100 has the shape of is a bent channel configured to be placed around a portion of the aorta 20 in the region of the aortic arch 30 and comprises openings 110a, 110b in the form of through holes for accommodating branching blood vessels 29,28,27 connected to the aorta.
  • the second portion P2 has a width in the range 8mm - 18mm, in the direction of the length extension LE of the aorta 20, and as such, the first opening 110a also has a width in the range 8mm - 18mm to be able to accommodate the Brachiocephalic artery 29.
  • the third portion P3 of the vessel member 100 encircles the aorta 20 and is positioned between the Brachiocephalic artery 29 and the left common Carotid artery 28. To be suitible for placement between the Brachiocephalic artery 29 and the left common Carotid artery 28, the third portion P3 has a width in the range 3mm - 15mm, in the direction of the length extension LE of the aorta 20.
  • Fig. 19C shows an embodiment similar to the embodiment shown in fig. 19A, the difference being that in the embodiment of fig. 19C, the connection 650 comprising the hydraulic conduit is connected to the third segment 120c.
  • the implantable system then comprises a second hydraulic conduit 65 lb for creating a fluid connection between the third segment 120c and the second segment 120b, and a first hydraulic conduit 651a for creating a fluid connection between the second segment 120b and the first segment 120a.
  • the first and second hydraulic conduits 65 la, 65 lb also comprise electric leads for transferring electrical signals to and from the first and second segments 120a, 120b, via the third segment 120c, to an implantable controller controlling the adjustment of the adjustable vessel member 100.
  • the electrical signals may be signals containing information from at least one sensor placed in the first and/or second segment 120a, 120b, the details of which are further described with reference to figs. 51 A - 5 IE.
  • Each of the first, second and third segments 120a, 120b, 120c comprises at least one control valve for controlling the flow of hydraulic fluid between the three segments 120a, 120b, 120c, such that the hydraulic cuffs of the first, second and third segments 120a, 120b, 120c can be individually adjusted.
  • connection between the first and second segments 120a, 120b, and between the second and third segments 120b, 120c are fluid conduits creating a fluid connection.
  • the connection may be a connection for transferring electrical or mechanical energy for mechanically or electrically operating cuffs for exerting force on the aorta 20.
  • Figs. 20A, 20B and 20C shows an embodiment of a vessel member 100 in which the vessel member 100 is configured to be placed around and follow a blood vessel having a curvature, such as the aortic arch.
  • the vessel member 100 has an inner portion IP and an outer portion OP.
  • the inner portion IP is configured to be placed proximal to the heart of the patient and the outer portion OP is configured to be placed distal to the heart of the patient.
  • the inner portion IP has an inner length IL in the direction of the length extension LE of the aorta
  • the outer portion OP has an outer length OL in the direction of the length extension LE of the aorta.
  • the outer length OL is longer than the inner length IL.
  • the vessel member 100 is configured to be placed on the aortic arch of the patient, and the inner length IL is the length placed most proximal to the heart of the patient, and the outer length OL is the length placed most distal to the heart of the patient, when the vessel has been implanted around the aorta at the aortic arch of the patient.
  • the outer length OL is more than 1,2 times the length of the inner length IL, more specifically, more than 1,5 times the length of the inner length IL.
  • the outer length OL is more than 2mm and the inner length IL is more than 4 mm, more specifically, the outer length is more than 3mm and the inner length is more than 6mm.
  • the inner portion IP, and thus the third curvature C3, is configured to be placed proximal to the heart of the patient, and the outer portion OP, and thus the first curvature Cl, is configured to be placed distal to the heart of the patient.
  • the aorta is placeable between the first and third curvatures C1,C3.
  • the first curvature Cl has a first radius rl and the third curvature C3 has a third radius r3.
  • the first radius rl is larger than the third radius r3. More specifically, in the embodiment shown in figs. 20A - 20C, the first radius rl is at least 1,5 times the third radius r3.
  • the first radius rl is in the range 8mm - 45mm, more specifically in the range 10mm - 40mm, and even more specifically in the range 12mm - 35mm
  • the third radius r3 is in the range 5mm - 25mm, more specifically in the range 6mm - 20mm, and even more specifically in the range 8mm - 20mm.
  • Fig. 20C shows a cross-sectional view A - A of the section of fig. 20b, i.e. showing half of the vessel member in a sectional side view, looking in the direction of the length extension LE.
  • the vessel member 100 has a second curvature C2 configured to follow a curvature of the circumference of the aorta, in a cross-sectional plane perpendicular to the length extension LE of the aorta.
  • the aorta is a tube shaped blood vessel with a circular circumference and the vessel member 100 is configured to follow the circular circumference by means of the second curvature C2 of the vessel member 100.
  • the second curvature has a second radius r2.
  • the second radius is in the range 3mm - 25mm, depending on the size of the patient and the anatomy of the aneurysm. More specifically, the second radius is in the range 4mm - 15mm, and even more specifically, the second radius is in the range 6mm - 12mm.
  • the segments 120a - 120e are connected to each other such that the joint between the segments 120a - 120e is more perpendicular than parallel to the length extension and thereby the direction of the blood flow in the aorta. More specifically, the joint between the segments 120a - 120e is substantially perpendicular to the direction of the length extension.
  • the first and second segments 120a, 120b has a width W1 (could also be expressed as length in the direction of the length extension LE of the aorta 20), in the range 3mm - 10mm and the third segment 120c has a width of 2*W1, thus being in the range 6mm - 20mm.
  • the third segment has a width which is at more than 1,2 times the width of the second segment 120b, more specifically, the third segment 120c has a width which is two times the width of the second segment 120b.
  • the resilient material is a silicone-based polymer material, such that the blood vessel 20 is not harmed by the inner surface 121a - 121c engaging the blood vessel.
  • the three curvatures C1,C2,C3 could be curvatures having the same radii, or could, as is the case in the embodiment shown in fig,. 24A, have different radii to follow the curvature of an aneurysm which in most cases is not uniform.
  • the inner surface 121a - 121c of the vessel member 100 comprises three inflatable portions in the form of three hydraulic cuffs 601a - 601c, each facing the outer surface of the blood vessel.
  • the inner circumference of the cuffs 601a - 601c forms the outer circumference of the enclosing cross-sectional area.
  • the hydraulic cuffs 601a - 601c are each connected to a hydraulic operation device comprising a control valve 660 by means of fluid conduits 65 la - 651c.
  • the hydraulic cuffs 601a - 601c are individually hydraulically adjustable.
  • the implantable system may further comprise a third sensor incorporated in the controller 300 (not shown) and configured to sense a parameter related to the power consumption of the implantable system, which could be used as a parameter to determine the pressure exerted on the blood vessel 20, or a parameter related to a status of the energy storage unit or related to a wireless transfer of energy from a source external to the body of the patient.
  • the status of the energy storage unit or wireless transfer of energy may be used for assessing the functional status of the implantable system to notify the patient or medical professional if anything is wrong with the device or if the implantable system needs charging or maintenance.
  • Fig. 25A shows an embodiment of the implantable system for handling aneurysm, in an embodiment in which the vessel member 100 is very similar to the vessel member 100 of the embodiment of fig. 24B.
  • the implantable system comprises a mechanical operation device for mechanically adjusting the distance between the inner surface 121a - 121c of the vessel member 100 and the outer surface of the blood vessel 20, and the pressure exerted by the vessel member 100 on the blood vessel 20, when the inner surface 121a - 121c of the vessel member is placed in engagement with the outer surface of the blood vessel 20.
  • the mechanical operation device is integrated with the vessel member 100, such that the operation device forms part of the vessel member 100.
  • the motors MOI - MO3 being part of the operation device are enclosed in a housing 484 integrated with the vessel member 100.
  • the operation device is thus integrated with the vessel member 100.
  • the operation device comprises an electrical connection 650 connecting the operation device with a remote member (such as further described with reference to figs. 3,17 and 26A - 45C) for providing the electrical motors MOI - MO3 with electrical energy.
  • Fig. 25B shows an embodiment of the implantable system for handling aneurysm, in an embodiment very similar to the embodiment described with reference to fig. 25A.
  • the vessel member 100 only comprises a first and a second individually adjustable band 656a, 656b, and the first and a second adjustable bands 656a, 656b are connected to force transferring elements in the form of flexible shafts in the form of Bowden cables 663a, 663b configured to transfer linear force from the remote unit 600 to the vessel member 100.
  • the motors MOI and MO2 are placed in a remote unit 600.
  • Fig. 25C shows an embodiment of the implantable system for handling aneurysm in an alternative mechanical embodiment similar to that described with reference to fig. 25 A.
  • the implantable system comprises a mechanical operation device for mechanically adjusting the distance between contacting elements 674 on the inner surface of the vessel member 100, and the outer surface of the blood vessel 20, and for mechanically adjusting the pressure exerted by the contacting elements 674 of the vessel member 100 on the blood vessel 20.
  • the mechanical operation device is integrated with the vessel member 100, such that the operation device forms part of the vessel member 100.
  • Fig. 25E shows an embodiment of the implantable system for handling aneurysm in an alternative electrical embodiment similar to that described with reference to fig. 25D.
  • the vessel member 100 comprises a stimulation device 677 comprises a plurality of electrodes adapted to be placed in close connection to the aneurysm.
  • the electrodes of the stimulation device 677 are adapted to provide an electrical stimulation pulse on a wall portion of the aneurysm.
  • the electrical stimulation pulse can for example be generated by a pulse generator which may be placed in the vessel member on in a remote unit.
  • the electrodes are adapted to stimulate the wall of the aneurysm at multiple stimulation points.
  • the multiple stimulation points may be organized in different stimulation groups which can stimulate independently of each other.
  • the electrical stimulation can be performed with positive and or negative voltage stimulation pulses.
  • the sequence of electrical pulses used to stimulation the wall of the aneurysm can be applied with a predetermined periodicity having periods of no stimulation therein between during which periods without stimulation the wall of the aneurysm is allowed to rest.
  • the electrical stimulation signal can also be Pulse Width Modulated to control the energy applied.
  • the electrical stimulation may be applied during the systolic phase to increase the tonus of the wall of the aneurysm.
  • the systolic phase can be detected by the sensors used to sense the pressure of the aneurysm as described above with reference to fig. 24A and 24B.
  • the stimulation can be controlled to be applied with a temporarily increased intensity and position during emergency situations when the aneurysm is detected to rapidly expands, to limit the expansion of the aneurysm.
  • Figs. 26a, 26b and 27 show an embodiment of a remote unit 600 which may be used in combination with any of the hydraulically operable implantable systems for handling an aneurysm and hydraulically operable adjustable vessel members of such systems.
  • the remote unit 600 is configured to be held in position by a tissue portion 610 of a patient, which may be a muscle tissue portion of the abdominal wall, such as further described with reference to fig. 17.
  • the remote unit 600 comprises a first portion 641 ’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641 ’ having a first cross-sectional area A 1 in a first plane PL 1 and comprising a first surface 614 configured to face a first tissue surface 616 of the first side 612 of the tissue portion 610.
  • the remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area A2 in a second plane PL2 and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610.
  • the remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610.
  • the connecting portion 642 here has a third cross- sectional area A3 in a third plane PL3 and a fourth cross-sectional area A4 in a fourth plane PL4 and a third surface 624 configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.
  • the connecting portion 642 is configured to connect the first portion 641’ to the second portion 641”.
  • the remote unit 600 is configured such that, when implanted, the first portion 641 ’ will be placed closer to an outside of the patient than the second portion 641”. Furthermore, in some implantation procedures the remote unit 600 may be implanted such that space will be available beyond the second portion, i.e. beyond the second side 618 of the tissue portion 610, whereas there may be as much space on the first side 612 of the tissue portion. Furthermore, tissue and/or skin may exert a force on the first portion 641” towards the tissue portion 610, and provide for that the second portion 641” does not travel through the hole in the tissue portion towards the first side 612 of the tissue portion. Thus, it is preferably if the remote unit 600 is primarily configured to prevent the first portion 641” from travelling through the hole in the tissue portion 612 towards the second side 618 of the tissue portion 610.
  • the first portion 641 ’ may further comprise one or several connections 605 for transferring energy and/or communication signals to the second portion 641” via the connecting portion 642.
  • the connections 605 in the illustrated embodiment are symmetrically arranged around a circumference of a protrusion 607 of the first portion 641 ’ and are arranged to engage with a corresponding connection 609 arranged at an inner surface of the connecting portion 642.
  • the protrusion 607 may extend in a central extension Cl of the central portion 642.
  • the second portion 641” may also comprise one or several connections 611, which may be similarly arranged and configured as the connections 605 of the first portion 641’.
  • any of the first surface 614 of the first portion 641’, the second surface 620 of the second portion 641’, the third surface 624 of the connecting portion 642, and an opposing surface 613 of the connecting portion 642, may be provided with at least one of ribs, barbs, hooks, a friction enhancing surface treatment, and a friction enhancing material, to facilitate the remote unit 600 being held in position by the tissue portion, and/or to facilitate that the different parts of the device are held in mutual position.
  • the opposing surface 613 of the connecting portion 642 and the first surface 614 of the first portion 641 ’ may provide, fully or partly, a connection mechanism to detachably connect the first portion 641’ to the connecting portion 642.
  • the opposing surface 613 may be provided with a recess configured to house at least part of the first portion 641 ’ .
  • such recess may be configured to receive at least a portion of the first portion 641’, including the first surface 614.
  • the first surface 614 may be provided with a recess configured to house at least part of the connecting portion 642.
  • such recess may be configured to receive at least a portion of the connecting portion 642, and in some embodiments such recess may be configured to receive at least one protruding element to at least partially enclose at least one protruding element or flange.
  • the first portion 641’ comprises a first energy storage unit 304a and a controller 300a comprising one or several processing units connected to the first energy storage unit 304a.
  • the first energy storage unit 304a may be rechargeable by wireless transfer of energy.
  • the first energy storage unit 304a may be non-rechargeable. Upon reaching the life-time end of such first energy storage, a replacement first portion comprising a new first energy storage unit may simply be swapped in place for the first portion having the depleted first energy storage unit.
  • the second portion 641” may further comprise a controller 300b comprising one or several processing units.
  • the first portion 641 ’ and the second portion 641 may comprise one or several functional parts, such as receivers, transmitters, transceivers, control units, processing units, sensors, energy storage units, sensors, etc.
  • the remote unite 600 may be non-inflatable.
  • the second portion 641 ” in the illustrated embodiment comprises a pump 604, the specific embodiment of which is disclosed with reference to fig. 49h.
  • the connecting portion 642 such as second portions 641” comprising a motor for providing mechanical work without the use of fluids or any of the other pumps described with reference to figs. 46a - 50.
  • the connecting portion 642 is illustrated in Fig. 26a as a separate unit, the connecting portion 642 may form part of the second portion 641” such that the portions forms part of a single unit.
  • the first portion 641 ’ may be detachably connected to at least one of the connecting portion 642 and the second portion 641”.
  • Fig. 26b shows an embodiment similar to that of the embodiment of fig. 26a, the only difference being that the first and second connection 650a, 650b comprising hydraulic conduits are connected to the hydraulic pump 604 such that hydraulic fluid can be conducted to a first and second receiver of hydraulic fluid (e.g. for hydraulically operating a first and second hydraulic member / hydraulic cuff for exerting pressure on a blood vessel).
  • the outflow from the hydraulic pump to the conduits 650a, 650b is controlled by two valves 660a, 660b which are electrically actuated and controlled from the controller 300 of the remote unit 600.
  • the first, second, third and fourth planes PL1, PL2, PL3 and PL4, are parallel to each other.
  • the third cross-sectional area A3 is smaller than the first, second and fourth cross-sectional areas Al, A2 and A4, such that the first portion 641’, second portion 641” and connecting portion 642 are prevented from travelling through the hole in the tissue portion 610 in a direction perpendicular to the first, second and third planes PL1, PL2 and PL3.
  • the second portion 641” and the connecting portion 642 can be held in position by the tissue portion 610 of the patient also when the first portion 641 ’ is disconnected from the connecting portion 642.
  • the connecting portion 642 illustrated in Fig. 26a may be defined as a connecting portion 642 comprising a flange 626.
  • the flange 626 thus comprises the fourth cross-sectional area A4 such that the flange 626 is prevented from travelling through the hole in the tissue portion 610 in a direction perpendicular to the first, second and third planes PL1, PL2 and PL3.
  • the flange 626 may protrude in a direction parallel to the first, second, third and fourth planes PL1, PL2, PL3 and PL4. This direction is perpendicular to a central extension Cl of the connecting portion 642.
  • the height Hl of the first portion 641 ’ in a direction perpendicular to the first plane may be less than a height H2 of the second portion 641” in said direction, such as less than half of said height H2 of the second portion 641 ”in said direction, less than a quarter of said height H2 of the second portion 641 ”in said direction, or less than a tenth of said height H2 of the second portion 641” in said direction.
  • Wireless energy receivers and/or communication receivers and/or transmitters in the first portion 141’ may be configured to receive energy from and/or communicate wirelessly with an external device outside the body using electromagnetic waves at a frequency below 100 kHz, or more specifically below 40 kHz, or more specifically below 20 kHz.
  • the wireless energy receivers and/or communication receivers and/or transmitters in the first portion 141’ may thus be configured to communicate with the external device using “Very Low Frequency” communication (VLF).
  • VLF signals have the ability to penetrate a titanium housing of the implantable energized medical device, such that the electronics of the implantable medical device can be completely encapsulated in a titanium housing.
  • first portion 141’ and second portion 141 may be made using VLF signals.
  • receivers and transmitters (for energy and/or communication) of the first portion 141’ and second portion 141” are configured accordingly.
  • the at least one protruding element 626 may have an annular shape, such as a disk shape. However, elliptical, elongated and/or other polyhedral or irregular shapes are also possible. In the illustrated embodiment, the at least one protruding element 626 extends a full revolution around the center axis of the connecting portion 642. However, other arrangements are possible, wherein the at least one protruding element 626 constitute a partial circle sector. In the case of a plurality of protruding elements, such plurality of protruding elements may constitute several partial circle sectors.
  • the connecting portion 642 may comprise at least two protruding elements 626, 627.
  • the connecting portion 642 may comprise at least three, four, five, fix, seven, eight, nine, ten protruding elements, and so on.
  • the at least two protruding elements 626, 627 may together comprise the fourth cross-sectional area, thus providing a necessary cross-sectional area to prevent the first portion and second portion from travelling through the hole in the tissue portion.
  • the first portion 641 ’ may comprise a first energy storage unit for supplying the remote unit 600 with energy.
  • the kit for assembling the remote unit comprises a first portion 641 ’, a group of three connecting portions 642a, 642b, 642c, and a group of two second portions 641”a,641”b.
  • first portions, second portions and connecting portions will not be illustrated or described in detail.
  • the different types of second portions 641” comprise a second portion 641’ ’b being configured to eccentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the first end of the second portion 641”b comprises or is configured for at least one connection for connecting to an implantable medical device for stretching the stomach wall of the patient, being located in a cranial direction from a location of the remote unit in the patient, when the device is assembled.
  • the at least one connection is visualized as a lead or wire.
  • the first end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
  • the remote unit may be modular, and different types of devices can be achieved by selecting and combining a first portion 641’, a connecting portion 642, and a second portion 641”, from each of the groups.
  • receivers and transmitters may be discussed and illustrated separately in the present disclosure, it is to be understood that the receivers and/or transmitters may be comprised in a transceiver. Furthermore, the receivers and/or transmitters in the first portion 641 ’ and second portion 641” respectively may form part of a single receiving or transmitting unit configured for receiving or transmitting energy and/or communication signals, including data. Furthermore, the internal wireless energy transmitter and/or a first wireless communication receiver/transmitter may be a separate unit 308c located in a lower portion of the first portion 641’, referred to as a proximal end of the first portion 641 ’ in other parts of the present disclosure, close to the connecting portion 642 and the second portion 641”. Such placement may provide for that energy and/or communication signals transmitted by the unit 308c will not be attenuated by internal components of the first portion 641 ’ when being transmitted to the second portion 641”. Such internal components may include a first energy storage unit 304a.
  • the first wireless energy receiver 308a is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the internal wireless energy transmitter 308a is configured to wirelessly transmit energy stored in the first energy storage unit 304a to the second wireless energy receiver 308b, and the second wireless energy receiver 308b is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter 308a and store the received energy in the second energy storage unit 304b.
  • the second controller may further be connected to a second wireless communication transmitter 308b for transmitting wireless communication to the first portion 641’.
  • the sensor could in alternative embodiment be configured to sense at least one physiological parameter of the patient.
  • the physiological parameter of the patient could be related to the blood pressure of the patient, the size of the aneurysm, the expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
  • the physiological parameter may also comprise a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
  • the sensor may be configured to sense a temperature of the implantable system to avoid excessive heating of tissue connected to the implantable system during operation, or during charging of an energy storage unit in the implantable system. Excessive heating may also damage the implantable system and/or the energy storage unit. Excessive heating may also be an indicator that something is wrong with the implantable system and may be used for triggering an alarm function for alerting the patient or physician.
  • the sensor may also be configured to sense a parameter related to the power consumption of the implantable system, to avoid excessive power consumption which may drain and/or damage the energy storage unit. Excessive power consumption may also be an indicator that something is wrong with the implantable system and may be used for triggering an alarm function for alerting the patient or physician.
  • the remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area A2 in a second plane PL2 and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610.
  • the remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610.
  • the connecting portion 642 here has a third cross-sectional area A3 in a third plane PL3.
  • the connecting portion 642 is configured to connect the first portion 641 ’ to the second portion 641”.
  • a connecting interface 630 between the connecting portion 642 and the second portion 641 ” is eccentric with respect to the second portion 641”.
  • the first portion 641’ has an elongated shape in the illustrated embodiment of Fig. 34.
  • the second portion 641” has an elongated shape.
  • the first portion 641’ and/or second portion 641” may assume other shapes, such as a flat disk e.g. having a width and length being larger than the height, a sphere, an ellipsoid, or any other polyhedral or irregular shape, some of these being exemplified in Figs. 34 - 36.
  • the connecting interface 630 between the connecting portion 642 and the second portion 641” may be eccentric, with respect to the second portion 641” in a first direction 631, but not in a second direction 633 being perpendicular to the first direction.
  • the first direction 631 is here parallel to the line A-A, to the second plane PL2, and to a length of the second portion 641”.
  • the second direction 633 is here parallel to the line B-B, to the second plane PL2, and to a width of the second portion 641 ”. It is also possible that the connecting interface between the connecting portion 642 and the second portion 641 ” is eccentric, with respect to the second portion 641 ”, in the first direction 631 as well as in the second direction 633 being perpendicular to the first direction 631.
  • a connecting interface between the connecting portion 642 and the first portion 641 ’ may be eccentric with respect to the first portion 641’ in the first direction 631 , and/or in the second direction 633.
  • the first portion 641’, connecting portion 642 and second portion 641” may structurally form one integral unit. It is however also possible that the first portion 641 ’ and the connecting portion 642 structurally form one integral unit, while the second portion 641” form a separate unit, or, that the second portion 641” and the connecting portion 642 structurally form one integral unit, while the first portion 641 ’ form a separate unit.
  • the term “flat” is related to the height of the first or second portion 641’, 641”, i.e. in a direction parallel to a central extension Cl of the connecting portion 642.
  • the term “oblong” is related to a length of the first or second portion 641’, 641”. A definition of such length is further discussed in other parts of the present disclosure.
  • the second portion 641 has a first end 632 and a second end 634 opposing the first end 632.
  • the length of the second portion 641” is defined as the length between the first end 632 and the second end 634.
  • the length of the second portion 641” is furthermore extending in a direction being different to the central extension C 1 of the connecting portion 642.
  • the first end 632 and second end 634 are separated in a direction parallel to the second plane PL2.
  • the first portion 641’ has a length between a first and a second end, the length extending in a direction being different to the central extension C 1 of the connecting portion 642.
  • the second portion 641 has a proximal region 636, an intermediate region 638, and a distal region 640.
  • the proximal region 636 extends from the first end 632 to an interface between the connecting portion 642 and the second portion 641”
  • the intermediate region 638 is defined by the connecting interface 630 between the connecting portion 642 and the second portion 641
  • the distal region 640 extends from the connecting interface 630 between the connecting portion 642 and the second portion 641 ” to the second end 634.
  • the proximal region 636 is shorter than the distal region 640 with respect to the length of the second portion, i.e. with respect to the length direction 631.
  • a heel the proximal region
  • a toe the distal region
  • Figs. 37C - 37D illustrate an embodiment similar to the one described in conjunction with Figs. 37A - 37B.
  • the embodiment of Figs. 37C - 37D lacks a proximal portion, i.e. the second portion 641” does not comprise a “heel”.
  • such embodiment may have a connecting portion 642 having a length and width, in directions 631 and 633 respectively, being equal to a height of the second portion in a direction parallel to the central extension Cl, as illustrated.
  • the connectiioOng portion 642 and the second portion 641” may be constituted by a substantially uniformly wide body.
  • the connecting portion 642 may have an elongated cross-section in the third plane. It may be particularly advantageous if the connecting portion 642 has a longer length 644 than width 648, said length 644 extending in the same direction as a length direction of the second portion 641”, i.e. in the same direction as an elongation of the second portion 641”.
  • the elongation of the connecting portion 642 may run in the same direction as an elongation of the hole in the tissue portion.
  • One and the same remote unit 600 may be capable of assuming several different arrangements with regards to rotational displacement of the first portion 641 ’ and the second portion 641 ” .
  • this is possible when the first portion 641 ’ and/or the second portion 641” is configured to detachably connect to the interconnecting portion 642.
  • a connection mechanism between the first portion 641 ’ and the connecting portion 642, or between the second portion 641” and the connecting portion 642 may possess a rotational symmetry to allow the first portion 641 ’ to be set in different positions in relation to the connecting portion 642 and in extension also in relation to the second portion 641”.
  • rotational symmetry may allow the second portion 642” to be set in different positions in relation to the connecting portion 642 and in extension also in relation to the first portion 641’.
  • the remote unit 600 is configured to be held in position by a tissue portion 610 of a patient.
  • the remote unit 600 comprises a first portion 641’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641’ having a first cross-sectional area in a first plane and comprising a first surface configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610.
  • the second portion 641 may comprise a removable and/or interchangeable portion 639 as described in other parts of the present disclosure.
  • Fig. 431 illustrate an embodiment wherein the lengthwise cross-sectional area decreases in a stepwise manner towards the second end 634 of the second portion 641”.
  • the second portion 641 has three major segments 692, 693, 694 having substantially constant diameter and each respective diameter being smaller moving towards the second end 634, being connected by intermediate segments 695, 696, wherein the diameter decreases along the first direction 631.
  • Other variations of major segments having substantially constant diameter, and intermediate segments, having a decreasing diameter along the first direction 632 are possible, such as at least two major segments connected by a single intermediate segment with decreasing diameter, at least four major segments connected by three intermediate segments with decreasing diameter, and so on.
  • FIG. 43 J an implantable energized medical device similar to the one illustrated in fig. 43H is illustrated.
  • the second portion 641 has a decreasing lengthwise cross-sectional area towards the second end.
  • the upper surface 697 is also visible in this view, being substantially flat and providing a contact area to the second tissue surface 622.
  • the first lengthwise cross-sectional area 689 is larger than the second cross-sectional area 690, as can be seen in figs. 43J - 43L, and the first lengthwise cross- sectional area 689 is located closer to the connecting interface between the connecting portion 642 and the second portion 641” with regard to the first direction.
  • the remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface of the second side 618 of the tissue portion 610.
  • the remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610.
  • the connecting portion 642 here has a third cross-sectional area in a third plane.
  • the connecting portion 642 is configured to connect the first portion 641’ to the second portion 641”.
  • At least one of the first portion and the second portion comprises at least one coil embedded in a ceramic material, the at least one coil being configured for at least one of: receiving energy transmitted wirelessly, transmitting energy wirelessly, receiving wireless communication, and transmitting wireless communication.
  • the first portion 641’ comprises a first coil 658 and a second coil 660
  • the second portion 641” comprises a third coil 662.
  • the coils are embedded in a ceramic material 664
  • the first portion 641 ’ may comprise a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter, and further the first portion 641 ’ may comprise a first wireless communication receiver.
  • the first wireless energy receiver and the first wireless communication receiver may comprise the first coil. Accordingly, the first coil may be configured to receive energy wirelessly, and/or to receive communication wirelessly.
  • the receiver/transmitter comprising the coil
  • said coil may form part of the receiver/transmitter
  • the first portion 641 ’ may comprise an internal wireless energy transmitter, and further a first wireless communication transmitter.
  • the internal wireless energy transmitter and/or the first wireless communication transmitter comprises the first coil 658.
  • the internal wireless energy transmitter and/or the first wireless communication transmitter comprises the second coil 660.
  • the second coil 660 is here arranged at the proximal end 665 of the first portion 641’. Such placement of the second coil 660 may provide for that energy and/or communication signals transmitted by the second coil 660 will not be attenuated by internal components of the first portion 641’ when being transmitted to the second portion 641”.
  • the first wireless energy receiver and the internal wireless energy transmitter comprises a single coil embedded in a ceramic material. Accordingly, a single coil may be configured for receiving energy wirelessly and for transmitting energy wirelessly. Similarly, the first wireless communication receiver and the first wireless communication transmitter may comprise a single coil embedded in a ceramic material. Even further, in some embodiments a single coil may be configured for receiving and transmitting energy wirelessly, and for receiving and transmitting communication signals wirelessly.
  • the second portion 641 comprises a distal end 668 and a proximal end 670, here defined with respect to the connecting portion 642.
  • the proximal end 668 is arranged closer to the connecting portion 642 and closer to the first portion 641 ’ when the remote unit 600 is assembled.
  • the third coil 662 is arranged at the proximal end 668 of the second portion 641”. Such placement of the third coil 662 may provide for that energy and/or communication signals received by the third coil 662 will not be attenuated by internal components of the second portion 641” when being received from the first portion 641’.
  • the first portion 641’ may comprise a first controller 300a connected to the first coil 658, second coil 660, and/or third coil 662.
  • the second portion 641” may comprise a second controller 300b connected to the first coil, 658, second coil 660, and/or third coil 662.
  • the first coil 658 is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the first coil 658 and/or the second coil 660 may be configured to wirelessly transmit energy stored in the first energy storage unit 304a to the third coil 662, and the third coil 662 may be configured to receive energy transmitted wirelessly by the first coil 658 and/or the second coil 660 and store the received energy in the second energy storage unit 304b.
  • the first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b.
  • charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow.
  • a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first and/or second coil and the third coil.
  • Figs. 45A and 45B illustrate a gear arrangement and magnetic coupling for coupling the remote unit to an implant exerting force on a body part, and in particular a gear arrangement for transferring mechanical movement through an outer housing of the device or an outer housing of the second portion 641”.
  • the remote unit may comprise at least part of a magnetic coupling, such as a magnetic coupling part 490a.
  • a complementary part of the magnetic coupling such as magnetic coupling part 490b, may be arranged adjacent to the remote unit 600, so as to magnetically couple to the magnetic coupling part 490a and form the magnetic coupling.
  • the magnetic coupling part 490b may form part of an entity not forming part of the remote unit 600.
  • the second portion 641” comprises several chambers being hermetically sealed from each other. Such chambers may be coupled via a magnetic coupling as discussed herein.
  • the magnetic coupling 490a, 490b provide for that mechanical work output by the remote unit 600 via e.g. an electric motor can be transferred from the device to an implantable medical device for stretching the stomach wall of the patient.
  • the magnetic coupling 490a, 490b provides for that mechanical force can be transferred through the housing 484.
  • the coupling between components may be achieved by e.g. a shaft or the like.
  • a force output of a motor MO in the second portion 641 is connected to the magnetic coupling part 490a.
  • the magnetic coupling part 490a transfers the force output from the motor MO to the magnetic coupling part 490b, i.e. via the magnetic coupling 490a, 490b.
  • the force output transferred via the magnetic coupling 490a, 490b here has a torque Tl, which is substantially the same torque as delivered by the motor MO.
  • the magnetic coupling part 490b is connected to a gear arrangement G, located external to the device, for example in a medical implant configured to exert force on a body part, or intermediate to a medical implant configured to exert force on a body part.
  • the gear arrangement G is configured to increase the torque of the force delivered via the magnetic coupling 490a, 490b to deliver a force with torque T2 being higher than torque Tl to a medical implant. Consequently, low torque may be provided by the motor MO, i.e. a relatively small force with high angular velocity, which is transferred via the magnetic coupling 490a, 490b before the torque is increased via gear arrangement G to achieve a relatively large force with low angular velocity.
  • the magnetic coupling 490a, 490b may utilize relatively weak magnetic forces to transfer the mechanical work through the housing 484 of the device without the risk of slipping between the magnetic coupling parts 490a, 490b.
  • a force output of a motor MO in the second portion 641” is connected to a first gear arrangement Gl, which in turn is coupled to the magnetic coupling part 490a.
  • the motor MO here provides a mechanical force with torque TO.
  • the magnetic coupling part 490a transfers the force output from the motor MO to the first gear arrangement Gl.
  • the first gear arrangement Gl is configured to increase the torque of the force delivered from the motor MO to deliver a force with a higher torque Tl to the magnetic coupling 490a, 490b.
  • the magnetic coupling part 490a transfers the force with torque Tl to the magnetic coupling part 490b.
  • the magnetic coupling part 490b is connected to a second gear arrangement G2, located external to the device, for example in a medical implant configured to exert force on a body part, or intermediate to a medical implant configured to exert force on a body part.
  • the second gear arrangement G2 is configured to increase the torque of the force delivered via the magnetic coupling 490a, 490b to deliver a force with torque T2 being higher than torque Tl, and thus higher than torque TO, to a medical implant. Consequently, low torque may be provided by the motor MO, i.e. a relatively small force with high angular velocity.
  • the torque of the force provided by the motor MO is then increased by the first gear arrangement Gl, before the force is transferred via the magnetic coupling 490a, 490b.
  • the torque of the force transferred via the magnetic coupling 490a, 490b is then yet again increased via the second gear arrangement G2 to achieve a relatively large force with low angular velocity.
  • the magnetic coupling 490a, 490b may utilize relatively weak magnetic forces to transfer the mechanical work through the housing 484 of the device without the risk of slipping between the magnetic coupling parts 490a, 490b.
  • the gear arrangements Gl, G2 may be sized and configured appropriately to share the work of increasing the torque.
  • Fig. 45C schematically illustrates an energy storage 304b connected to a wireless energy transmitter 308.
  • the energy storage 304b and the wireless energy transmitter 308 are arranged in one portion or chamber of the second portion 641”.
  • a wireless energy receiver 308e is arranged in another portion or chamber of the second portion 641”.
  • the portions or chambers may be separated or defined by respective housings, external walls and/or internal walls 484a, 484b.
  • the wireless energy transmitter 308d is configured to wirelessly transmit energy to the wireless energy receiver 308e.
  • the wireless energy transmitter 308d and wireless energy receiver 308e may comprise one or more coils, respectively.
  • the compression member 402 is propelled by the motor MO via a gear system G.
  • the hollow member 401 is placed inside a peristaltic pump housing 403, such that the hollow member 401 is compressed between the operable compression member 402 and the housing 403.
  • the peristaltic pump 604 is a sealed pump which means that fluid will not leak through the pump even at standstill. As the peristaltic pump 604 is a sealed pump no additional valve is needed to keep the fluid through the fluid conduits 65 la, 65 lb closed.
  • the deflectable hollow member 401 is connected to or integrated with fluid conduits 65 la, 65 lb, which in turn are connectable with fluid conduits of the hydraulic operation devices in any of the embodiments described herein.
  • the compression member 402 When the compression member 402 is propelled in a counterclockwise direction, it creates a peristaltic wave which presses hydraulic fluid through the hollow member 401 and further through the second portion of the fluid conduit 65 lb.
  • the compression member 402 When the compression member 402 is propelled in a clockwise direction, it creates a peristaltic wave which presses hydraulic fluid through the hollow member 401 and further through the first fluid conduit 651a.
  • the system could comprise several peristaltic pumps 604 of the embodiment of fig. 46A and 46B.
  • the electrical motor could be an electrical motor MO selected from an alternating current (AC), a linear electrical motor, an axial electrical motor, a piezo-electric motor, a multiple phase motor, such as a three-phase motor, a bimetal motor, and a memory metal motor.
  • AC alternating current
  • linear electrical motor linear electrical motor
  • axial electrical motor axial electrical motor
  • piezo-electric motor piezo-electric motor
  • multiple phase motor such as a three-phase motor, a bimetal motor, and a memory metal motor.
  • the controller 300, the energy storage unit 40 and the motor MO and gear system G may be enclosed by a housing 484 such that the controller 300 is protected from bodily fluids.
  • the housing 484 may be an enclosure made from one of or a combination of: a carbon based material (such as graphite, silicon carbide, or a carbon fiber material), a boron material, a polymer material (such as silicone, Peek®, polyurethane, UHWPE or PTFE,), a metallic material (such as titanium, stainless steel, tantalum, platinum, niobium or aluminum), a ceramic material (such as zirconium dioxide, aluminum oxide or tungsten carbide) or glass.
  • a carbon based material such as graphite, silicon carbide, or a carbon fiber material
  • a boron material such as silicone, Peek®, polyurethane, UHWPE or PTFE,
  • a metallic material such as titanium, stainless steel, tantalum, platinum, niobium or aluminum
  • the force output 449 of the gear system G is threaded 449t and engages a correspondingly threaded portion 45 It of the movable wall 451 such that the rotating force created by the motor MO and gear system G is transferred to a linear force moving the movable wall 451.
  • the threaded force output 449 is enclosed by pleated bellows portions 452 both above and below the movable wall 451 such that the threaded force output 449 is protected from the fluid in the lumens of the reservoirs 607a, 607b.
  • the force output 449 is, in the embodiment described in fig. 49A a hollow shaft equipped with inner threads (not shown) adapted to engage outer threads 453t of a threaded member 453, such that the interaction between the hollow shaft 449 and the threaded member 453 transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force.
  • the threaded member 453 is connected to a radially extending engaging member 454 adapted to engage the first and second reservoirs 607a, 607b containing a hydraulic fluid.
  • the motor MO is configured to generate force in a radial direction by rotation of the force output in the form of a shaft 481.
  • the shaft 481 is equipped with outer threads 48 It adapted to engage inner threads 483t of a compression member 483, such that the interaction between the threaded shaft 481, 48 It and the threaded portion 483t of the compression member 483 transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T.
  • the axial force acts on the compression member 483 which engages a first resilient wall 602a of the compressible reservoir 607 for compressing the compressible reservoir 607 and thus increasing the pressure on a hydraulic fluid in the compressible reservoir 607.
  • the first resilient wall portion 604a is more resilient than the second resilient wall portion 604b such that the compressible reservoir 604 can create a suction when the compression member 483 moves in the direction away from the compressible reservoir 604 thus enabling the compressible reservoir 604 to expand.
  • a major portion of the first resilient wall portion is made from a material having a modulus of elasticity (E) which is less than 70% or the modulus of elasticity (E) of the material of a major portion of the second resilient wall portion 604b.

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Abstract

According to a first aspect, a device for treating an aneurysm of a blood vessel of a mammal patient is provided. The device comprises an operable implantable member adapted to be placed in connection with the blood vessel having the aneurysm. The implantable member is adapted to partially enclose the circumference of the aneurysm such that at least one branch arising from the vessel is not enclosed by the implantable member.

Description

A DEVICE FOR TREATMENT OF ANEURYSM OF A BLOOD VESSEL
Field of the invention
The present invention relates to a device for treating a vascular aneurysm of a human or mammal patient.
Background
An aneurysm is a blood-filled dilation (balloon-like bulge) of a blood vessel, caused by a weakened vessel wall. The weakened vessel wall can be congenital, or be a result from a gradual weakening by for example high blood pressure (hypertension). The bulge extends radially perpendicular to the direction of the blood flow in the vessel. The aneurysm will naturally grow larger with time, thus, increasing the fatal risk of rupturing the vessel. If left undetected and given enough time, the aneurysm will inevitably grow and reach its bursting point.
The abdominal aorta is the part of the aorta supplying blood to the abdominal cavity. It begins at the aortic hiatus at the level of the T12 vertebra in the diaphragm, and ends approximately 15 cm inferior with the aortic bifurcation at the level of the L4 vertebra, at which location the width of the aorta is approximately 2-3 centimeters.
The arteries supplying the abdominal organs arise from the abdominal aorta in branches being visceral (pertaining to the internal organs) or parietal (relating to the walls of the abdominal cavity), and paired or unpaired. The paired parietal inferior phrenic arteries stem from the abdominal aorta at T12 and supply the inferior surface of the diaphragm. The visceral celiac trunk is unpaired and also emerges at T12. It divides into three branches (left gastric, splenic and common hepatic arteries) and supplies the stomach, liver, pancreas, spleen and a part of the small intestine. At LI, the visceral, unpaired superior mesenteric artery arises which supplies a large part of the intestines. The visceral suprarenal arteries are paired, located at LI and supplies the adrenal glands above the kidneys. Between LI and L2 the visceral renal arteries emerge. They are paired and supply the kidneys. The paired visceral gonadal arteries (called testicular arteries and ovarian arteries in males and females respectively) arise at L2 and extend into the scrotum in males, and pelvis in females. At L3 the visceral inferior mesenteric artery is located, which is unpaired and the final major branch of the abdominal aorta. It supplies the distal part of the large intestine, and branches out into the left colic, sigmoidal and superior rectal arteries. The parietal lumbar arteries arise horizontally in four pairs from the lumbar region (the region pertaining to the abdominal section between the diaphragm and torso) of the aorta and support the abdominal wall. At the aortic bifurcation at L4, the abdominal aorta splits into the common iliac arteries which supply the inferior part of the abdominal wall as well as the pelvis and lower limbs. From the most inferior part of the abdominal aorta, the median sacral artery emerges. It is unpaired and supplies the sacrum and coccyx.
Further details can be found in for example MARIEB E. N., MALLATT J., 2003, Human Anatomy, San Francisco: Benjamin Cummings, the content of which is hereby incorporated by reference.
Given the possibly fatal outcome of an undetected and untreated aneurysm, screenings are now commonly performed in order to enable early detection of the presence of an aneurysm. The existing treatments include a surgical procedure in which a tube-like sleeve is implanted from the groin of the patient. The sleeve acts as an artificial artery and is placed at the site of the aneurysm where it allows the blood flow to by-pass the aneurysm. This method however has the drawback of embolism possibly forming due to the introduction of alien material in the bloodstream.
At least for the reasons mentioned above, there exists a need for a treatment of an aortic aneurysm that brings about fewer complications.
Summary
It is an object of the invention to mitigate, alleviate or eliminate one or more of the deficiencies in the prior art. This and other objects, which will become apparent in the following, are accomplished by a device and system as defined in the accompanying independent claims.
According to one embodiment, an implantable system for handling an aneurysm in a blood vessel of a patient is provided. The system comprises at least one adjustable vessel member configured for at least partially contacting a portion of the aorta at the aortic arch of the patient. The system further comprises an implantable operation device for post-operatively adjusting the at least one adjustable vessel member. The aortic arch has a curvature in the direction of the length extension of the aorta, and the at least one adjustable vessel member comprises an inner surface configured to face an outer surface of the aorta.
The inner surface of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension of the aorta, such that the inner surface follows the curvature of the aortic arch, and/or, the inner surface of the at least one adjustable vessel member comprises at least a first and a second portion, the first and second portions are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension of the aorta.
The first and second portions may be materially integrated.
According to one embodiment, the adjustable vessel member has an inner portion and an outer portion. The inner portion is configured to be placed proximal to the heart of the patient and the outer portion is configured to be placed distal to the heart of the patient. The inner portion has an inner length in the direction of the length extension of the aorta, and the outer portion has an outer length in the direction of the length extension of the aorta. The outer length is longer than the inner length. The outer length may be at least 1,2 times the length of the inner length, or at least 1,4 times the length of the inner length, or at least 1,6 times the length of the inner length, or at least 2 times the length of the inner length.
According to one embodiment, the outer length is at least 2 mm and the inner length is at least 4 mm. According to one embodiment, the outer length is at least 3 mm and the inner length is at least 6 mm.
The adjustable vessel member may comprise a first part comprising the inner portion and a second part comprising the outer portion, and the first and second parts may be adapted to be connected to each other to form at least a portion of the adjustable vessel member. According to one embodiment, at least one portion of the adjustable vessel member formed by the connection of the first and second parts is adapted to enclose a portion of the aorta at the aortic arch of the patient.
According to one embodiment, the first and second parts are adapted to be connected to each other such that the joint between the first and second parts is more parallel than perpendicular to the direction of the blood flow.
According to one embodiment, the first and second parts are adapted to be connected to each other such that the joint between the first and second parts is substantially parallel to the direction of the blood flow.
According to one embodiment, the inner surface of the vessel member comprises a first curvature configured to follow the curvature of the aortic arch in the direction of the length extension of the aorta, and a second curvature configured to follow a curvature of the circumference of the aorta, in a cross-sectional plane perpendicular to the length extension of the aorta.
According to one embodiment, of the implantable system, the first curvature has a first radius (rl), the second curvature (c2) has a second radius (r2), and the first radius (rl) is larger than the second radius (r2).
According to one embodiment, the adjustable vessel member has an inner portion and an outer portion. The inner portion is configured to be placed proximal to the heart of the patient and the outer portion is configured to be placed distal to the heart of the patient. The first curvature is located on the inner surface of the outer portion, and the third curvature is located on the inner surface of the inner portion and is configured to follow the curvature of the aortic arch in the direction of the length extension of the aorta, such that the aorta is placeable between the first and third curvatures. The first curvature has a first radius, the third curvature has a third radius, and the first radius is larger than the third radius.
According to one embodiment, the first radius is at least 2 times the second radius. According to one embodiment, the first radius is at least 1,5 times the third radius. According to one embodiment, the third radius is at least 1,5 times the second radius.
According to one embodiment, the first radius is in the range 12mm - 45mm, preferably in the range 15mm - 40mm, and more preferably in the range 20mm - 40mm.
According to one embodiment, the second radius is in the range 3mm - 25mm, preferably in the range 4mm - 15mm, and more preferably in the range 6mm - 12mm.
According to one embodiment, the third radius is in the range 5mm - 25mm, preferably in the range 6mm - 20mm, and more preferably in the range 8mm - 20mm. According to one embodiment, a first straight line extends on the inner surface of the first portion, and a second straight line extends on the inner surface of the second portion. The first straight line is connected to the second straight line and the first straight line is angled with a first angle in relation to the second straight line. The first angle may be in the range 3° - 90°, or may be in the range 5° - 45°.
According to one embodiment, the first straight line has a length exceeding 4mm and the second straight line has a length exceeding 4mm.
The adjustable vessel member may have an inner portion and an outer portion. The inner portion may be configured to be placed proximal to the heart of the patient and the outer portion may be configured to be placed distal to the heart of the patient. The first straight line extends on the inner surface of the first portion of the outer portion, and the second straight line extends on the inner surface of the second portion of the outer portion.
According to one embodiment, a third straight line extends on the inner surface of the first portion, and a fourth straight line extends on the inner surface of the second portion. The third straight line is connected to the fourth straight line, the third straight line is angled with a second angle in relation to the fourth straight line, and the first angle is different from the second angle. According to one embodiment, the first angle is smaller than the second angle. According to one embodiment, the first angle is more than 3° smaller than the second angle, and according to one embodiment, the first angle is more than 5° smaller than the second angle.
According to one embodiment, the adjustable vessel member has an inner portion and an outer portion. The inner portion is configured to be placed proximal to the heart of the patient and the outer portion is configured to be placed distal to the heart of the patient. The third straight line extends on the inner surface of the first portion of the inner portion, and the fourth straight line extends on the inner surface of the second portion of the inner portion.
According to one embodiment, the first straight line and the third straight line are configured to extend on opposite sides of the aorta.
According to one embodiment, the at least one adjustable vessel member comprises a first segment comprising the first portion, and a second segment comprising the second portion.
According to one embodiment, the first segment comprises a first connection interface, and the second segment comprises a second connection interface configured to mate with the first connection interface, such that the first and second segments can be connected for creating the adjustable vessel member configured to follow the curvature in the direction of the length extension of the aorta.
According to one embodiment, the first and second segments, when assembled, cover a distance in the range 5mm - 100mm of the aorta in the direction of length extension of the aorta, preferably a distance in the range 10mm - 50mm of the aorta in the direction of length extension of the aorta.
According to one embodiment, the first and second segments forms a bent channel configured to be placed around at least a portion of the aorta in the region of the aortic arch.
According to one embodiment, the first segment is angled in relation to the second segment, such that the adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension of the aorta.
According to one embodiment, the first segment is displaced in relation to the second segment, such that the adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension of the aorta.
According to one embodiment, the first segment comprises at least one recess and the second segment comprises at least one protrusion, and the first segment is connectable to the second segment by the at least one protrusion being placed in the at least one recess.
According to one embodiment, the first and second segments are adapted to be assembled such that the joint between the first and second segments is more perpendicular than parallel to the direction of the blood flow.
According to one embodiment, the first and second segments are adapted to be assembled such that the joint between the first and second segments is substantially perpendicular to the direction of the blood flow.
According to one embodiment, the adjustable vessel member further comprises a third segment configured to be connected to the second segment.
According to one embodiment, the first segment has a length in the range 3mm - 30mm and the second segment has a length in the range 3mm - 30mm, more preferably, the first segment has a length in the range 5mm - 20mm and the second segment has a length in the range 5mm - 20mm.
According to one embodiment, the first segment has a length which is at least 1,2 times the length of a length of the second segment. According to one embodiment, the first segment has a length which is at least 1,5 times the length of a length of the second segment. According to one embodiment, the first segment has a length which is at least 2 times the length of a length of the second segment.
According to one embodiment, a first portion of the adjustable vessel member comprises a first enclosing cross-sectional area perpendicular to the direction of the length extension of the aorta, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the aorta. A second portion of the adjustable vessel member comprises a second enclosing cross-sectional area perpendicular to the direction of the length extension of the aorta. The second enclosing cross-sectional area is configured for at least partially enclosing a portion of the aorta, and the second enclosing cross-sectional area is larger than the first enclosing cross- sectional area.
According to one embodiment, the first segment of the adjustable vessel member comprises the first enclosing cross-sectional area, and the second segment of the adjustable vessel member comprises the second enclosing cross-sectional area.
According to one embodiment, a third segment of the vessel member comprises a third enclosing cross-sectional area, and according to one embodiment, the third enclosing cross- sectional area is larger than the second enclosing cross-sectional area, and according to another embodiment, the third enclosing cross-sectional area is smaller than the second enclosing cross- sectional area.
According to one embodiment, the at least one opening or the at least one recess in positioned at a joint between two or more segments of the adjustable vessel member, or at a joint between two or more parts of the adjustable vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
According to one embodiment, the adjustable vessel member can be at least partially opened for being introduced over the aorta for at least partially enclosing the aorta. In one embodiment, the adjustable vessel member comprises at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the aorta for at least partially enclosing the aorta.
According to one embodiment, the adjustable vessel member comprises at least one of an opening for accommodating at least one blood vessel connected to the aorta, and a recess for accommodating at least one blood vessel connected to the aorta.
The at least one opening could comprise at least one through-hole for accommodating the at least one blood vessel connected to the aorta, and/or could comprise at least one slit for accommodating the at least one blood vessel connected to the aorta.
According to one embodiment, the adjustable vessel member further comprises a third portion configured to encircle the aorta. In one embodiment, the second portion of the adjustable vessel member comprises at least one opening for accommodating at least one blood vessel connected to the aorta, and the third portion of the adjustable vessel member is configured to encircle the aorta.
In any of the embodiments herein, the at least one blood vessel connected to the aorta could be at least one branch from the aorta.
According to one embodiment, the at least one blood vessel connected to the aorta is at least one of the: brachiocephalic artery, the left common carotid artery and the left subclavian artery. The distance between an edge of the at least one opening and the at least one blood vessel connected to the aorta could be between 1mm and 10mm, to prevent the edge of the at least one opening from being placed in contact with the blood vessel and as such preventing damaging the blood vessel.
According to one embodiment, the at least one opening is annular and may have a diameter in the range of 1mm - 15mm, or preferably in the range 3mm - 12mm, or preferably in the range 3mm - 10mm.
According to one embodiment, the adjustable vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other, or radially displaced at an angle in the range 20° - 120° in relation to each other.
According to one embodiment, the recess comprises at least one furrow adapted to accommodate the at least one blood vessel connected to the aorta, and in one embodiment, the furrow extends substantially in the direction of the length extension of the aorta. The furrow may extend in a direction at an angle in relation to the direction of the length extension of the aorta being an angle in the range 10° - 45°.
According to one embodiment, the recess extends on an inner surface of the adjustable vessel member, such that the recess accommodates the blood vessel connected to the aorta between the adjustable vessel member and the aorta.
According to one embodiment, the adjustable vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other, or radially displaced at an angle in the range 20° - 120° in relation to each other.
According to one embodiment, the adjustable vessel member comprises at least one recess connected to at least one opening, such that the blood vessel connected to the aorta can extend in the recess and further through the opening.
According to one embodiment, the first and second segments of any one of the embodiments herein comprises the opening and according to one embodiment the first and second segments comprises a through hole and/or a slit.
According to one embodiment, the first and second segments comprises the recess for accommodating the blood vessel connected to the aorta.
According to one embodiment, the first and second segments comprises a furrow.
According to one embodiment, the first segment comprises at least one of a first opening and a first recess for accommodating at least one first blood vessel connected to the aorta, and the second segment comprises at least one of a second opening and a second recess for accommodating at least one second blood vessel connected to the aorta. According to one embodiment, the at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess are radially displaced at an angle in relation to each other, in relation to the aorta, along a center axis of the aorta. The angle may be an angle in the range 10° - 180°, or an angle in the range 20° - 120°.
According to one embodiment, the at least one opening or the at least one recess in positioned at a joint between two or more segments of the vessel member, or at a joint between two or more parts of the vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
According to one embodiment, the vessel member comprises at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the aorta. The at least one branch supporting element may be configured to encircle a branching blood vessel.
According to one embodiment, the adjustable vessel member is configured to be placed at a distance from the aorta, such that the inner surface does not engage the outer surface of the aorta. Having the adjustable vessel member normally being placed at a distance from the aorta, reduces the risk that the adjustable vessel member wears on the aorta and damages the tissue wall of the aorta. According to one embodiment, the adjustable vessel member is configured to be placed at a distance in the range 0,5mm - 5mm from the aorta, or at a distance in the range 1mm - 3mm from the aorta, such that the inner surface of the adjustable vessel member does not engage the outer surface of the aorta.
According to one embodiment, the inner surface of the adjustable vessel member is configured to engage the outer surface of the aorta. The inner surface of the adjustable vessel member may comprise at least one inflatable portion at least partially facing the outer surface of the aorta. The adjustable vessel member may be adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
According to one embodiment, the inflatable portion is connected to a valve for controlling the flow of a fluid to and from the inflatable portion. The first segment may comprise a first inflatable portion and the second segment may comprise a second inflatable portion. The first inflatable portion may be connected to a first valve for controlling the flow of a fluid to and from the first inflatable portion and the second inflatable portion may be connected to a second valve for controlling the flow of a fluid to and from the second inflatable portion.
According to one embodiment, the implantable system further comprises a conduit for creating a fluid connection between the first and second inflatable portion. According to one embodiment, the adjustable vessel member comprises an elastic material, and the vessel member may be adapted to exert a mechanical pressure by the elastic properties of the elastic material.
According to one embodiment, the first segment is configured to exert a first pressure on the aorta and the second segment is configured to exert a second pressure on the aorta, and wherein the first and second pressures are individually adjustable.
The adjustable vessel member may be configured to exert an adjustable pressure on the aorta, and the system may further comprise an implantable controller for adjusting the pressure exerted on the aorta by the adjustable vessel member.
The operation device in any of the embodiments herein may comprise a hydraulic operation device, and the implantable system may further comprise an expandable hydraulic reservoir.
The expandable hydraulic reservoir may be in fluid connection with an inflatable portion of the adjustable vessel member, and the pressure exerted on the aorta from the inflatable member can be controlled by controlling a flow of fluid from the expandable hydraulic reservoir to the inflatable portion.
According to one embodiment, the implantable system further comprises a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion via the fluid connection for adjusting the pressure exerted on the aorta from the inflatable member. The pump may be connected to the controller such that the controller can control the operation of the pump.
According to one embodiment, the operation device may comprise a mechanical operation device configured to adjust the pressure exerted by the adjustable vessel member on the aorta.
The mechanical operation device may comprise an electrical motor configured to adjust the pressure exerted by the adjustable vessel member on the aorta.
The at least one adjustable vessel member may comprise an enclosing cross-sectional area perpendicular to the direction of the length extension of the aorta, the enclosing cross-sectional area may be configured for at least partially enclosing a portion of the aorta.
According to one embodiment, the mechanical operation device may be adapted to adjust the pressure exerted by the adjustable vessel member on the aorta by altering the size of the enclosing cross-section area.
The hydraulic operation device may be adapted to adjust the pressure exerted by the adjustable vessel member on the blood vessel by altering the size of the enclosing cross-section area.
The implantable system may in any of the embodiments herein further comprise at least one sensor connected to the implantable controller. The sensor may be a sensor configured to sense a physical parameter of the implantable system. The physical parameter of the implantable system may comprise at least one of: a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
The sensor may configured to sense a parameter related to strain in the implantable system may be configured to sense a strain in the adjustable vessel member connected to the expansion of the aneurysm.
According to one embodiment, the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the adjustable vessel member.
According to one embodiment, the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the adjustable vessel member.
According to one embodiment, the inner surface of the adjustable vessel member comprises the sensor or is connected to the sensor. The sensor may be connected to the expandable hydraulic reservoir, and the sensor may be configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
According to one embodiment, the sensor is connected to the inflatable portion, and the sensor is configured to sense an expansion of the aneurysm by sensing at least one of a pressure change and a volume change in the inflatable portion.
The sensor may be configured to sense at least one physiological parameter of the patient, which may be an expansion of the aneurysm and/or a size of the aneurysm and/or a local temperature and/or a systemic temperature and/or blood saturation and/or blood oxygenation and/or blood pressure and/or a parameter related to an ischemia marker.
The sensor may be configured to sense an expansion of the aneurysm by sensing at least one of: a diameter or cross-sectional distance of the aorta, a wall thickness of the aorta, a flow rate through the aorta, or an optical parameter related to the state of the aorta.
The implantable controller may in any of the embodiments be configured to transmit information based on sensor input to a source external to the body of the patient, and the controller may be configured to transmit the information based on sensor input to a source external to the body of the patient, wirelessly.
According to one embodiment, the adjustable vessel member comprises an attachment device for attaching the adjustable vessel member to a portion of the body of the patient. The adjustable vessel member may comprise a first attachment device for attaching the first segment to a portion of the body of the patient and a second attachment device for attaching the second segment to a portion of the body of the patient. The attachment device may be configured to attach the adjustable vessel member to a portion of the body of the patient comprising bone.
According to one embodiment, the implantable system further comprises a remote unit connected to the adjustable vessel member, a major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the adjustable vessel member.
The remote unit may comprise at least a portion of the operation device.
According to one embodiment, the implantable system further comprises a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the adjustable vessel member, for operating the adjustable vessel member.
The adjustable vessel member may in any of the embodiments herein comprise at least part of the operation device, and the part of the operation device comprised in the adjustable vessel member may comprise a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the aorta. The mechanical force may be a linear mechanical force, or, the receiving portion may be configured to receive a rotating mechanical force and the transmission may be configured to transform the received rotating mechanical force into a liner mechanical force.
The transmission may comprise a gear system configured to reduce the velocity and increase the force of the received mechanical force. The portion of the operation device placed in the remote unit may comprise an electrical motor.
According to one embodiment, the portion of the operation device placed in the remote unit further comprises a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
The portion of the operation device placed in the adjustable vessel member may comprise a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the vessel. The transmission may comprise at least one hydraulic cylinder.
According to one embodiment, the portion of the operation device placed in the adjustable vessel member comprises a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
The portion of the operation device placed in the remote unit may comprise at least one operable valve for controlling a flow of hydraulic fluid. The operable valve may be configured to control the flow of hydraulic fluid between at least one of the expandable hydraulic reservoir and the first inflatable member, the expandable hydraulic reservoir and the second inflatable member, and the first inflatable member and the second inflatable member. The portion of the operation device placed in the remote unit may comprise at least one hydraulic pump and/or a hydraulic reservoir for holding a hydraulic fluid.
The remote unit may comprise an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
The remote unit may further comprise an energy storage unit for directly or indirectly energizing the implantable system.
The remote unit may further comprise and implantable controller, which in turn may comprise a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
The implantable system may further comprise at least one lead for transferring electrical energy and/or information from the remote unit to the adjustable vessel member.
The implantable system may further comprises a housing configured to enclose the remote unit. A first portion of the housing may be made from titanium and a second portion of the housing may be made from a ceramic material. The portion of the housing made from a ceramic material may comprise at least one coil embedded in the ceramic material.
The remote unit may comprise a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, the remote unit may further comprise a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion. The first, second and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
The first portion may be detachably connected to the connecting portion, and the second portion may be detachably connected to the connecting portion.
An implantable system for handling an aneurysm in a blood vessel of a patient is further provided. The system comprises a vessel member configured for at least partially contacting a portion of the blood vessel in a region of an aneurysm. The vessel member has an inner surface comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel. The vessel member comprises a first segment comprising the first portion, and a second segment comprising the second portion, wherein the first segment comprises a first connection interface, and the second segment comprises a second connection interface. The second connection interface is configured to mate with the first connection interface, such that the first and second segments can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension of the blood vessel. The inner surface of the vessel member may comprise at least one curvature extending over the first and second portions in the direction of the length extension of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel and/or the first and second portions may be angled or displaced relative to each other, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the first segment comprises a first connection interface, and the second segment comprises a second connection interface configured to mate with the first connection interface, such that the first and second segments can be connected for creating the vessel member configured to follow the curvature in the direction of the length extension of the blood vessel.
The first segment of the implantable system may comprise at least one recess and the second segment may comprise at least one protrusion. The first segment is connectable to the second segment by the at least one protrusion being placed in the at least one recess.
According to one embodiment, the first and second segments, when assembled, cover a distance of 5mm - 100mm of the blood vessel, in the direction of length extension of the blood vessel.
According to one embodiment, the first segment has a length which is at least 1,2 times the length of a length of the second segment.
According to one embodiment, the first segment has a length which is at least 2 times the length of a length of the second segment.
According to one embodiment, the first and second segments forms a bent channel configured to be placed around at least a portion of the blood vessel.
According to one embodiment, the first and second segments are adapted to be assembled such that the joint between the first and second segments is more perpendicular than parallel to the direction of the length extension of the blood vessel.
According to one embodiment, the first and second segments are adapted to be assembled such that the joint between the first and second segments is substantially perpendicular to the direction of the length extension of the blood vessel.
According to one embodiment, the vessel member further comprises a third segment configured to be connected to the second segment. According to one embodiment, the first segment has a length in the range 3mm - 30mm and the second segment has a length in the range 3mm - 30mm.
According to one embodiment, at least one of the first and second segments comprises a first part comprising the inner portion and a second part comprising the outer portion. The first and second parts are adapted to be connected to each other to enclose a portion of the blood vessel.
According to one embodiment, the first and second parts are adapted to be connected to each other such that the joint between the inner and outer parts is substantially parallel to the direction of the blood flow.
According to one embodiment, the inner surface comprises a first curvature configured to follow the curvature of the curvature of the blood vessel in the direction of the length extension of the blood vessel, and a second curvature configured to follow a curvature of the circumference of the blood vessel, in a cross-sectional plane perpendicular to the length extension of the blood vessel.
According to one embodiment, the first curvature has a first radius, the second curvature has a second radius, and the first radius is larger than the second radius.
According to one embodiment, the first radius is at least 2 times the second radius.
According to one embodiment, the first radius is in the interval 10mm - 80mm, or 10mm - 60mm, or 20mm - 60mm.
According to one embodiment, the second radius is in the interval 2mm - 25mm, or 4mm - 12mm, or 6mm - 12mm.
According to one embodiment, a first portion of the vessel member comprises a first enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, a second portion of the vessel member comprises a second enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the second enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, and the second enclosing cross-sectional area is larger than the first enclosing cross-sectional area.
According to one embodiment, the first segment of the vessel member comprises the first enclosing cross-sectional area, and the second segment of the vessel member comprises the second enclosing cross-sectional area.
According to one embodiment, a third segment of the vessel member comprises a third enclosing cross-sectional area, and the third enclosing cross-sectional area may be larger than the second enclosing cross-sectional area, or the third enclosing cross-sectional area may be smaller than the second enclosing cross-sectional area. According to one embodiment, a first straight line extends on the inner surface of the first portion, and a second straight line extends on the inner surface of the second portion. The first straight line is connected to the second straight line, and the first straight line is angled with a first angle in relation to the second straight line.
The first angle may be in the range 3° - 90°, or in the range 5° - 45°.
The first straight line may have a length exceeding 4mm and the second straight line has a length exceeding 4mm.
According to one embodiment, the vessel member of the implantable system has an inner portion and an outer portion. A first straight line extends on the inner surface of the first portion of the outer portion, and a second straight line extends on the inner surface of the second portion of the outer portion. A third straight line may extend on the inner surface of the first portion, and a fourth straight line may extend on the inner surface of the second portion. The third straight line is connected to the fourth straight line and the third straight line is angled with a second angle in relation to the fourth straight line. The first angle may be different from the second angle. In one embodiment, the first angle is smaller than the second angle, and in one embodiment the first angle is more than 3° smaller than the second angle.
According to one embodiment, the vessel member has an inner portion and an outer portion, and a third straight line extends on the inner surface of the first portion of the inner portion, and a fourth straight line extends on the inner surface of the second portion of the inner portion. The first straight line and the third straight line may be configured to extend on opposite sides of the blood vessel.
According to one embodiment, at least one of the segments can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
According to one embodiment, at least one of the segments comprises at least one pivot joint for enabling the at least one segment to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel. At least one of the segments may comprise at least one of an opening for accommodating the at least one branching blood vessel, and a recess for accommodating the at least one branching blood vessel.
The at least one opening may comprise at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel and/or at least one slit for accommodating the at least one branching blood vessel connected to the blood vessel.
According to one embodiment, the vessel member further comprising a third segment comprising a third connection interface configured to mate with the second connection interface of the second segment, such that the first, second and third segments can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension of the blood vessel. The first segment of the vessel member may be configured to encircle the blood vessel, and the second segment of the vessel member may comprise at least one opening for accommodating at least one branching blood vessel connected to the blood vessel, and the third segment of the vessel member may be configured to encircle the blood vessel.
According to one embodiment, the blood vessel is the aorta.
According to one embodiment, the at least one branching blood vessel is at least one of: the Brachiocephalic artery, the left common Carotid artery, the left Subclavian artery, the Intercostal arteries, the Bronchial arteries, the Mediastinal arteries, the Esophageal arteries, the Pericardial arteries, the Phrenic arteries, the Celiac trunk, the Suprarenal arteries, the Renal arteries, the Mesenteric arteries, the Gonadal arteries, and the Lumbar arteries.
According to one embodiment, the distance between an edge of the at least one opening and the at least one branching blood vessel connected to the blood vessel is configured to be between 1mm and 10mm.
According to one embodiment, the at least one opening is annular, and the annular opening may have a diameter in the range of 1mm - 10mm. According to one embodiment, the vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
According to one embodiment, the recess comprises at least one furrow adapted to accommodate at least one branching blood vessel. The furrow may be adapted to accommodate at least one branching blood vessel extending substantially in the direction of the length extension of the blood vessel. The furrow may be adapted to accommodate at least one branching blood vessel extending in a direction at an angle in relation to the direction of the length extension of the blood vessel, the angle being an angle in the range 10° - 45°. According to one embodiment, the recess extends on an inner surface of the vessel member, such that the recess accommodates the branching blood vessel between the vessel member and the blood vessel. According to one embodiment, the vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other. The vessel member may comprise at least one recess connected to at least one opening, such that a branching blood vessel can extend in the recess and further through the opening.
According to one embodiment, the first and second segments comprises the opening, which may be openings in the form of through hole(s) and/or slit(s).
According to one embodiment, the first and second segments comprises the recess for accommodating the at least one branching blood vessel.
According to one embodiment, the first and second segments comprises a furrow. According to one embodiment, the first segment comprises at least one of a first opening and a first recess for accommodating at least one first branching blood vessel, and the second segment comprises at least one of a second opening and a second recess for accommodating at least one second branching blood vessel.
The at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess may be radially displaced at an angle in relation to each other, in relation to the blood vessel, along a center axis of the blood vessel. The angle may be an angle in the range 10° - 180°.
According to one embodiment, the at least one opening or the at least one recess in positioned at a joint between two or more segments of the vessel member, or at a joint between two or more parts of the vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
According to one embodiment, the vessel member comprises at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the blood vessel.
According to one embodiment, the at least one branch supporting element is configured to encircle a branching blood vessel.
According to one embodiment, the vessel member may be configured to be placed at a distance from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel. The distance may be in the interval 0,5mm - 3mm from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel.
According to one embodiment, the inner surface of the vessel member is configured to engage the outer surface of the blood vessel. The inner surface of the vessel member may comprise at least one inflatable portion at least partially facing the outer surface of the blood vessel and the vessel member may be adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
According to one embodiment, the operation device may comprise at least one valve for controlling the flow of a fluid to and from the inflatable portion. The first segment may comprise a first inflatable portion and the second segment mat comprise a second inflatable portion. The operation device may comprise a first valve for controlling the flow of a fluid to and from the first inflatable portion, and a second valve for controlling the flow of a fluid to and from the second inflatable portion.
According to one embodiment, the system further comprises a conduit for creating a fluid connection between the first and second inflatable portion. According to one embodiment, the vessel member comprises an elastic material, and the vessel member may be adapted to exert a mechanical pressure by the elastic properties of the elastic material.
According to one embodiment, the first segment may be configured to exert a first pressure on the blood vessel and the second segment may be configured to exert a second pressure on the blood vessel. The first and second pressures may be individually adjustable.
The implantable system according to any one of the embodiment herein may further comprise an implantable controller for controlling the operation device. The implantable controller may be configured to control the operation device to adjust the pressure exerted on the blood vessel by the vessel member. The operation device may be a hydraulic operation device, and the implantable system could further comprises an expandable hydraulic reservoir.
The expandable hydraulic reservoir may be in fluid connection with the inflatable portion of the vessel member, and the pressure exerted on the blood vessel from the inflatable portion may be configured to be adjusted by the operation device creating a flow of fluid from the expandable hydraulic reservoir to the inflatable portion.
According to one embodiment, the operation device further comprises a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion for adjusting the pressure exerted on the blood vessel from the inflatable member. The pump may be connected to the implantable controller such that the implantable controller can control the operation of the pump. According to one embodiment, the operation device may comprise a mechanical operation device configured to adjust the pressure exerted by the vessel member on the blood vessel. The mechanical operation device may comprise an electrical motor configured to adjust the pressure exerted by the vessel member on the blood vessel.
The at least one vessel member may comprise an enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the enclosing cross- sectional area being configured for at least partially enclosing a portion of the blood vessel.
According to one embodiment, the mechanical operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area.
According to one embodiment, the hydraulic operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area.
The implantable system according to any one of the embodiments herein could further comprise at least one sensor connected to the implantable controller. The sensor could be a sensor configured to sense a physical parameter which comprise at least one of: a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
According to one embodiment, a sensor configured to sense a parameter related to strain in the implantable system is configured to sense a strain in the vessel member connected to the expansion of the aneurysm.
According to one embodiment, the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the vessel member.
According to one embodiment, the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the vessel member.
According to one embodiment, the inner surface of the vessel member comprises the sensor or is connected to the sensor.
According to one embodiment, the sensor is connected to the expandable hydraulic reservoir, and the sensor is configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
According to one embodiment, the sensor is connected to the inflatable portion, and the sensor is configured to sense an expansion of the aneurysm by sensing at least one of a pressure change and a volume change in the inflatable portion.
According to one embodiment, the sensor is configured to sense at least one physiological parameter of the patient, which may be a parameter related an expansion of the aneurysm, such as a circumference, diameter or cross-sectional area of the blood vessel. In the alternative, the physiological parameter of the patient could be related to the size of the aneurysm, such as the length, circumference, diameter or cross-sectional area of the aneurysm on the blood vessel.
According to one embodiment, the physiological parameter could be related to the blood pressure of the patient.
The sensor may in any of the embodiments herein be a sensor configured to sense at least one of: an expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
According to one embodiment, the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel. According to one embodiment, the implantable controller is configured to transmit information based on sensor input to a source external to the body of the patient. The transmission could be done wirelessly.
The implantable system could in any of the embodiments herein comprises an attachment device for attaching the vessel member to a portion of the body of the patient.
According to one embodiment, the portion of the body of the patient is a portion of the body of the patient comprising bone, such as the spine of the patient. By attaching to the spine, a stabile fixation is achieved. The attachment device could comprises an elastic member and the elastic properties of the elastic member could enable some movement in the attachment device which is necessary to compensate both for the general movement of the patient’s body as well as for the pulsation of the blood vessel and the patient’s respiration.
The elastic member could comprise a spring. By choosing a certain spring stiffness, the surgeon can control and adapt the amount of movement necessary in the device in order to keep the device in place, depending on location and size of the aneurysm.
The attachment may comprise an attachment plate which may have a curved shape adapted to fit the curvature of the spine.
According to one embodiment, the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising soft tissue. Also here, the attachment device could comprise at least one elastic member for connecting to a region of the body comprising soft tissue, which could be multiple elastic members connected to different regions of the body comprising soft tissue. By offering multiple elastic members, a more stable device is achieved, thus avoiding displacement of the device which could affect its result in treating the aneurysm.
According to another aspect, the soft tissue is muscle tissue, such as the right or left crus, the psoas minor, the psoas major, the quadratus lumborum, the transverse abdominal, the obliques, the iliacus or the diaphragm.
According to one embodiment, the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising fascia, which may be superficial fascia or deep fascia is deep. The fascia could be the transversalis fascia, the parietal peritoneum, the greater omentum, the lesser omentum, the linea alba.
According to one embodiment, the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising connective tissue, ligaments or fibrous tissue. The system may comprise a first attachment device for attaching the first segment to a first portion of the body of the patient and a second attachment device for attaching the second segment to a second portion of the body of the patient.
The implantable system according to any of the preceding embodiments could further comprise a remote unit connected to the vessel member. A major portion of the remote unit could be configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
The remote unit could comprise at least a portion of the operation device.
The implantable system could further comprise a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
The vessel member could comprise at least part of the operation device, and the part of the operation device comprised in the vessel member could comprise a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel. The receiving portion could be configured to receive a linear mechanical force, or a rotating mechanical force which may be transformed into a liner mechanical force.
The implantable system may further comprise a gear system configured to reduce the velocity and increase the force of the received mechanical force.
The portion of the operation device placed in the remote unit may comprise an electrical motor. The portion of the operation device placed in the remote unit may further comprise a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
The portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel. The transmission may comprise at least one hydraulic cylinder.
The portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
The operation device placed in the remote unit may comprise at least one operable valve for controlling a flow of hydraulic fluid between at least one of the expandable hydraulic reservoir and the first inflatable portion, the expandable hydraulic reservoir and the second inflatable portion, and the first inflatable member and the second inflatable portion. According to one embodiment, the portion of the operation device placed in the remote unit comprises at least one hydraulic pump.
The remote unit may further comprise a hydraulic reservoir for holding a hydraulic fluid and may comprise an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
The remote unit may further comprise an energy storage unit for directly or indirectly energizing the implantable system.
According to one embodiment, the remote unit further comprises the implantable controller, and the implantable controller may comprise a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
The implantable system could further comprise at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member.
The implantable system may further comprise a housing configured to enclose the remote unit. A first portion of the housing may be made from titanium and a second portion of the housing may be made from a ceramic material. The portion of the housing made from a ceramic material may comprise at least one coil embedded in the ceramic material.
The remote unit may comprise a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to engage a first tissue surface of the tissue portion. The remote unit may further comprise a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion. The first, second and third planes are parallel to each other, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
At least one of the first portion may be detachably connected to the connecting portion, and the second portion may be detachably connected to the connecting portion.
An implantable system for handling an aneurysm in a blood vessel of a patient is further provided. The implantable system comprising at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, and an implantable operation device for post-operatively adjusting the at least one adjustable vessel member. The at least one adjustable vessel member may comprise at least one of an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
According to one embodiment, the at least one opening may comprise at least one through- hole for accommodating the at least one branching blood vessel connected to the blood vessel. The through-hole may have a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2, preferably in the range 16mm2 - 80mm2.
According to one embodiment of the implantable system, the through-hole is annular, and may have a diameter in the range 1mm - 10mm, preferably in the range 3mm - 10mm.
According to one embodiment, the at least one opening comprises at least one slit for accommodating the at least one branching blood vessel. The slit adapted to accommodate at least one branching blood vessel may extend substantially in the direction of the length extension of the blood vessel.
The slit adapted to accommodate at least one branching blood vessel may extend in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
According to one embodiment, the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm, preferably in the range 1mm - 5mm.
The adjustable vessel member may comprise at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
According to one embodiment, the vessel member of the implantable system comprises at least one furrow adapted to accommodate at least one branching blood vessel. The furrow adapted to accommodate the at least one branching blood vessel may extend substantially in the direction of the length extension of the blood vessel, or may extend in a direction at an angle in relation to the direction of the length extension of the blood vessel, being an angle in the range 10° - 45°.
According to one embodiment, the recess extends on an inner surface of the adjustable vessel member, such that the recess accommodates the branching blood vessel between the adjustable vessel member and the blood vessel. The adjustable vessel member may comprise at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other.
According to one embodiment, the adjustable vessel member comprises at least one recess connected to at least one opening, such that a branching blood vessel can extend in the recess and further through the opening.
The implantable system may in any of the embodiments herein comprise a first segment and a second segment. The first segment may comprise a first connection interface and the second segment may comprise a second connection interface. The second connection interface may be configured to mate with the first connection interface, such that the first and second segments can be connected for at least partially forming the adjustable vessel member.
The first segment may comprise a first portion configured to encircle the blood vessel and the second segment may comprise a second portion comprising the opening for accommodating the at least one branching blood vessel, and/or the recess for accommodating the at least one branching blood vessel.
The first and second segments, when assembled, may cover a distance of 5mm - 100mm of the blood vessel in the direction of the length extension of the blood vessel..
According to one embodiment, the first and second segments forms a bent channel configured to be placed around at least a portion of the blood vessel.
The first segment could comprise at least one recess and the second segment could comprise at least one protrusion. The first segment may be connectable to the second segment by the at least one protrusion being placed in the at least one recess.
According to one embodiment, the first and second segments may be adapted to be assembled such that the joint between the first and second segments is more perpendicular than parallel to the direction of the length extension of the blood vessel.
According to one embodiment, the first and second segments may be adapted to be assembled such that the joint between the first and second segments is substantially perpendicular to the direction of the length extension of the blood vessel.
According to one embodiment, the first segment is angled in relation to the second segment, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the first segment is displaced in relation to the second segment, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the first segment has a length in the range 3mm - 30mm and the second segment has a length in the range 3mm - 30mm.
According to one embodiment, the first segment has a length which is at least 1,2 times the length of a length of the second segment, or a length which is at least 2 times the length of a length of the second segment.
According to one embodiment, the first and second segments comprises an opening, which may be a through hole and/or a slit.
The first and second segments may comprise the recess for accommodating the at least one branching blood vessel. The first and second segments may comprise a furrow, such as a furrow described in any of the embodiments herein. The first segment may comprise at least one of a first opening and a first recess for accommodating at least one first branching blood vessel, and the second segment may comprise at least one of a second opening and a second recess for accommodating at least one second branching blood vessel.
The at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess may be radially displaced at an angle in relation to each other, in relation to the blood vessel, along a center axis of the blood vessel. The angle may be an angle in the range 10° - 180°.
According to one embodiment, the adjustable vessel member may further comprise a third segment configured to be connected to the second segment. The third segment may comprise a third portion configured to encircle the blood vessel.
According to one embodiment, a first portion of the adjustable vessel member may comprise a first enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, a second portion of the adjustable vessel member may comprise a second enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the second enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, and the second enclosing cross-sectional area is larger than the first enclosing cross-sectional area.
According to one embodiment, a first segment of the adjustable vessel member may comprise the first enclosing cross-sectional area, and the second segment of the adjustable vessel member may comprise the second enclosing cross-sectional area.
The third segment of the vessel member may comprise a third enclosing cross-sectional area. The third enclosing cross-sectional area may be larger than the second enclosing cross- sectional area.
According to one embodiment, the third enclosing cross-sectional area is smaller than the second enclosing cross-sectional area.
According to one embodiment, the at least one opening or the at least one recess in positioned at a joint between two or more segments of the adjustable vessel member, or at a joint between two or more parts of the adjustable vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
According to one embodiment, the adjustable vessel member can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel. The adjustable vessel member may comprise at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel. According to one embodiment, the adjustable vessel member comprises an inner surface configured to face an outer surface of the blood vessel. The inner surface of the adjustable vessel member may comprise at least one curvature configured to be placed in the direction of the length extension of the blood vessel, such that the inner surface can follow a curvature of the blood vessel.
According to one embodiment, the adjustable vessel member comprises an inner surface configured to face an outer surface of the blood vessel. The inner surface of the adjustable vessel member could comprises at least a first and a second portion, and the first and second portions could be angled relative to each other, such that the adjustable vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the adjustable vessel member comprises an inner surface configured to face an outer surface of the blood vessel. The inner surface of the adjustable vessel member comprises at least a first and a second portion, and the first and second portions are displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the adjustable vessel member comprises a first part and a second part. The first and second parts are adapted to be connected to each other to form at least a portion of the adjustable vessel member. The first and second parts may be assembled such that the joint between the first and second parts is more parallel than perpendicular to the direction of the length extension of the blood vessel.
According to one embodiment, the first and second parts are adapted to be assembled such that the joint between the first and second parts is substantially parallel to the direction of the length extension of the blood vessel.
According to one embodiment of the implantable system, the inner surface of the vessel member comprises a first curvature configured to follow a curvature of the blood vessel in the direction of the length extension of the blood vessel, and a second curvature configured to follow a curvature of the circumference of the blood vessel, in a cross-sectional plane perpendicular to the length extension of the blood vessel. The first curvature has a first radius, and the second curvature has a second radius. The first radius may be larger than the second radius. In one embodiment, the first radius is at least 2 times the second radius. The first radius may be in the range 12mm - 45mm, or in the range 15mm - 40mm, or in the range 20mm - 40mm.
According to one embodiment, the second radius is in the range 3mm - 25mm, or in the range 4mm - 15mm, or in the range 6mm - 12mm.
According to one embodiment, a first straight line extends on the inner surface of the first portion, and a second straight line extends on the inner surface of the second portion. The first straight line is connected to the second straight line, and the first straight line is angled with a first angle in relation to the second straight line. The first angle may be is in the range 3° - 90°, or in the range 5° - 45°.
According to one embodiment, the first straight line has a length exceeding 4mm and the second straight line has a length exceeding 4mm.
The adjustable vessel member may have an inner portion and an outer portion, and a first straight line and a second straight line may extend on the inner surface of the inner portion. The first straight line is connected to the second straight line, and the first straight line is angled with a first angle in relation to the second straight line. A third straight line and a fourth straight line may extend on the inner surface of the outer portion, the third straight line may be connected to the fourth straight line, and the third straight line may be angled with a second angle in relation to the fourth straight line. The first angle may be different from the second angle. The first straight line and the third straight line may be configured to extend on opposite sides of the blood vessel. The adjustable vessel member may comprise at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the blood vessel. The at least one branch supporting element may be configured to encircle a branching blood vessel.
The vessel member in any one of the preceding embodiments may be configured to be placed in connection with the aorta of the patient, and the at least one branching blood vessel could be at least one of: the Brachiocephalic artery, the left common Carotid artery, the left Subclavian artery, the Intercostal arteries, the Bronchial arteries, the Mediastinal arteries, the Esophageal arteries, the Pericardial arteries, the Phrenic arteries, the Celiac trunk, the Suprarenal arteries, the Renal arteries, the Mesenteric arteries, the Gonadal arteries, and the Lumbar arteries.
According to one embodiment, the vessel member may be configured to be placed at a distance from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel. The distance may be in the interval 0,5mm - 3mm from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel.
According to one embodiment, the inner surface of the vessel member is configured to engage the outer surface of the blood vessel. The inner surface of the vessel member may comprise at least one inflatable portion at least partially facing the outer surface of the blood vessel and the vessel member may be adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
According to one embodiment, the operation device may comprise at least one valve for controlling the flow of a fluid to and from the inflatable portion. The first segment may comprise a first inflatable portion and the second segment mat comprise a second inflatable portion. The operation device may comprise a first valve for controlling the flow of a fluid to and from the first inflatable portion, and a second valve for controlling the flow of a fluid to and from the second inflatable portion.
According to one embodiment, the system further comprises a conduit for creating a fluid connection between the first and second inflatable portion.
According to one embodiment, the vessel member comprises an elastic material, and the vessel member may be adapted to exert a mechanical pressure by the elastic properties of the elastic material.
According to one embodiment, the first segment may be configured to exert a first pressure on the blood vessel and the second segment may be configured to exert a second pressure on the blood vessel. The first and second pressures may be individually adjustable.
The implantable system according to any one of the embodiment herein may further comprise an implantable controller for controlling the operation device. The implantable controller may be configured to control the operation device to adjust the pressure exerted on the blood vessel by the vessel member. The operation device may be a hydraulic operation device, and the implantable system could further comprises an expandable hydraulic reservoir.
The expandable hydraulic reservoir may be in fluid connection with the inflatable portion of the vessel member, and the pressure exerted on the blood vessel from the inflatable portion may be configured to be adjusted by the operation device creating a flow of fluid from the expandable hydraulic reservoir to the inflatable portion.
According to one embodiment, the operation device further comprises a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion for adjusting the pressure exerted on the blood vessel from the inflatable member. The pump may be connected to the implantable controller such that the implantable controller can control the operation of the pump. According to one embodiment, the operation device may comprise a mechanical operation device configured to adjust the pressure exerted by the vessel member on the blood vessel. The mechanical operation device may comprise an electrical motor configured to adjust the pressure exerted by the vessel member on the blood vessel.
The at least one vessel member may comprise an enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the enclosing cross- sectional area being configured for at least partially enclosing a portion of the blood vessel.
According to one embodiment, the mechanical operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area. According to one embodiment, the hydraulic operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area.
The implantable system according to any one of the embodiments herein could further comprise at least one sensor connected to the implantable controller. The sensor could be a sensor configured to sense a physical parameter which comprise at least one of: a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
According to one embodiment, a sensor configured to sense a parameter related to strain in the implantable system is configured to sense a strain in the vessel member connected to the expansion of the aneurysm.
According to one embodiment, the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the vessel member.
According to one embodiment, the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the vessel member.
According to one embodiment, the inner surface of the vessel member comprises the sensor or is connected to the sensor.
According to one embodiment, the sensor is connected to the expandable hydraulic reservoir, and the sensor is configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
According to one embodiment, the sensor is connected to the inflatable portion, and the sensor is configured to sense an expansion of the aneurysm by sensing at least one of a pressure change and a volume change in the inflatable portion.
According to one embodiment, the sensor is configured to sense at least one physiological parameter of the patient, which may be a parameter related an expansion of the aneurysm, such as a circumference, diameter or cross-sectional area of the blood vessel. In the alternative, the physiological parameter of the patient could be related to the size of the aneurysm, such as the length, circumference, diameter or cross-sectional area of the aneurysm on the blood vessel.
According to one embodiment, the physiological parameter could be related to the blood pressure of the patient.
The sensor may in any of the embodiments herein be a sensor configured to sense at least one of: an expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker. According to one embodiment, the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
According to one embodiment, the implantable controller is configured to transmit information based on sensor input to a source external to the body of the patient. The transmission could be done wirelessly.
The implantable system could in any of the embodiments herein comprises an attachment device for attaching the vessel member to a portion of the body of the patient.
According to one embodiment, the portion of the body of the patient is a portion of the body of the patient comprising bone, such as the spine of the patient. By attaching to the spine, a stabile fixation is achieved. The attachment device could comprises an elastic member and the elastic properties of the elastic member could enable some movement in the attachment device which is necessary to compensate both for the general movement of the patient’s body as well as for the pulsation of the blood vessel and the patient’s respiration.
The elastic member could comprise a spring. By choosing a certain spring stiffness, the surgeon can control and adapt the amount of movement necessary in the device in order to keep the device in place, depending on location and size of the aneurysm.
The attachment may comprise an attachment plate which may have a curved shape adapted to fit the curvature of the spine.
According to one embodiment, the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising soft tissue. Also here, the attachment device could comprise at least one elastic member for connecting to a region of the body comprising soft tissue, which could be multiple elastic members connected to different regions of the body comprising soft tissue. By offering multiple elastic members, a more stable device is achieved, thus avoiding displacement of the device which could affect its result in treating the aneurysm.
According to another aspect, the soft tissue is muscle tissue, such as the right or left crus, the psoas minor, the psoas major, the quadratus lumborum, the transverse abdominal, the obliques, the iliacus or the diaphragm.
According to one embodiment, the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising fascia, which may be superficial fascia or deep fascia is deep. The fascia could be the transversalis fascia, the parietal peritoneum, the greater omentum, the lesser omentum, the linea alba. According to one embodiment, the attachment device is configured to attach the implantable member to a portion of the body of the patient comprising connective tissue, ligaments or fibrous tissue.
The system may comprise a first attachment device for attaching the first segment to a first portion of the body of the patient and a second attachment device for attaching the second segment to a second portion of the body of the patient.
The implantable system according to any of the preceding embodiments could further comprise a remote unit connected to the vessel member. A major portion of the remote unit could be configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
The remote unit could comprise at least a portion of the operation device.
The implantable system could further comprise a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
The vessel member could comprise at least part of the operation device, and the part of the operation device comprised in the vessel member could comprise a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel. The receiving portion could be configured to receive a linear mechanical force, or a rotating mechanical force which may be transformed into a liner mechanical force.
The implantable system may further comprise a gear system configured to reduce the velocity and increase the force of the received mechanical force.
The portion of the operation device placed in the remote unit may comprise an electrical motor. The portion of the operation device placed in the remote unit may further comprise a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
The portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel. The transmission may comprise at least one hydraulic cylinder.
The portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
The operation device placed in the remote unit may comprise at least one operable valve for controlling a flow of hydraulic fluid between at least one of the expandable hydraulic reservoir and the first inflatable portion, the expandable hydraulic reservoir and the second inflatable portion, and the first inflatable member and the second inflatable portion.
According to one embodiment, the portion of the operation device placed in the remote unit comprises at least one hydraulic pump.
The remote unit may further comprise a hydraulic reservoir for holding a hydraulic fluid and may comprise an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
The remote unit may further comprise an energy storage unit for directly or indirectly energizing the implantable system.
According to one embodiment, the remote unit further comprises the implantable controller, and the implantable controller may comprise a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
The implantable system could further comprise at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member.
The implantable system may further comprise a housing configured to enclose the remote unit. A first portion of the housing may be made from titanium and a second portion of the housing may be made from a ceramic material. The portion of the housing made from a ceramic material may comprise at least one coil embedded in the ceramic material.
The remote unit may comprise a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to engage a first tissue surface of the tissue portion. The remote unit may further comprise a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion. The first, second and third planes are parallel to each other, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
At least one of the first portion may be detachably connected to the connecting portion, and the second portion may be detachably connected to the connecting portion.
An implantable system for handling an aneurysm in a blood vessel of a patient is further provided. The system comprises at least one vessel member configured for at least partially contacting a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel. The at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel. The system further comprises an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
According to one embodiment, the inner surface of the vessel member is configured to be placed at a distance from the outer surface of the blood vessel in the range 0,5mm - 10mm, or preferably at a distance from the outer surface of the blood vessel in the range 1mm - 5mm.
According to one embodiment, the inner surface of the vessel member comprises a resilient material, which may be a resilient polymer material such as a silicone-based material or polyurethane-based material.
According to one embodiment, the vessel member is an adjustable vessel member, for adjusting the distance between the inner surface of the vessel member and the outer surface of the blood vessel and/or a pressure exerted by the vessel member on the blood vessel.
According to one embodiment, the system further comprises an implantable operation device for postoperatively and non-invasively operating the adjustable vessel member, for adjusting the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and/or the pressure exerted by the vessel member on the blood vessel.
According to one embodiment, the implantable operation device is configured to adjust the adjustable vessel member such that the adjustable vessel member exerts a pressure on the outer surface of the blood vessel in the range between a systolic and a diastolic blood pressure of the patient.
According to one embodiment, the inner surface of the vessel member comprises at least one inflatable portion at least partially facing the outer surface of the blood vessel.
According to one embodiment, the operation device comprises a hydraulic operation device for hydraulically inflating the at least one inflatable portion at least partially facing the outer surface of the blood vessel.
According to one embodiment, the hydraulic operation device comprises at least one hydraulic pump for pumping a hydraulic fluid to and from the inflatable portion.
According to one embodiment, the hydraulic operation device comprises at least one valve for controlling the flow of a fluid to and from the inflatable portion.
According to one embodiment, the operation device comprises a mechanical operation device for mechanically adjusting the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and/or a pressure exerted by the vessel member on the blood vessel.
According to one embodiment, the operation device comprises an electrical operation device for electrically adjusting the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and/or a pressure exerted by the vessel member on the blood vessel.
According to one embodiment, the adjustable vessel member comprises an enclosing cross- sectional area perpendicular to the direction of the length extension of the blood vessel, the enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel. The adjustable vessel member is configured for adjusting at least one of the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and a pressure exerted by the vessel member on the blood vessel, by the adjustable vessel member altering the size of the enclosing cross-section area.
According to one embodiment, the adjustable vessel member comprises a cuff configured to encircle a portion of the blood vessel. The inner circumference of the cuff forms the outer circumference of the enclosing cross-sectional area. The adjustable vessel member is configured to alter the size of the enclosing cross-section area by altering the inner circumference of the cuff.
The adjustable vessel member comprises a first portion configured to be positioned such that an inner surface of the first portion faces a first portion of the outside of the blood vessel, and a second portion configured to be positioned such that an inner surface of the second portion faces a second portion of the outside of the blood vessel.
According to one embodiment, the first and second portions are individually adjustable.
According to one embodiment, the implantable system further comprises an implantable controller for controlling the operation device. The implantable controller may be configured to control the operation device to adjust the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and/or the pressure exerted by the vessel member on the blood vessel.
According to one embodiment, the implantable system further comprises at least one sensor configured to sense a connection between the inner surface of the vessel member and the outer surface of the blood vessel, and/or a pressure or force exerted by the blood vessel on the inner surface of the vessel member.
According to one embodiment, the implantable system further comprises at least one sensor configured to sense a parameter related to the expansion of the aneurysm. The sensor configured to sense an expansion of the aneurysm may be a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel. According to one embodiment, the sensor may be configured to sense at least one of: a pressure in an inflatable portion of the vessel member, a volume in an inflatable portion of the vessel member, a strain in the vessel member, an electrical connection or change in resistance, an optical change, and a temperature change.
The sensor may be connected to the implantable controller, and wherein the implantable controller may be configured to control the adjustable vessel member and/or transmit signals to a device external to the body of the patient and/or create a log entry - on the basis of a received input from the sensor.
According to one embodiment, the controller is configured to control the adjustable vessel member to increase the pressure exerted on the blood vessel by the adjustable vessel member in response to received input from the sensor. The at least one sensor may be configured to sense a parameter related to the power consumption of the implantable system and/or a parameter related to a status of the energy storage unit and/or a parameter related to a wireless transfer of energy from a source external to the body of the patient.
According to one embodiment, the sensor configured to sense a volume may be configured to sense a volume related to a volume of fluid in at least one inflatable portion of the vessel member.
According to one embodiment, the sensor configured to sense a pressure may be configured to sense a pressure in at least one inflatable portion of the vessel member.
According to one embodiment, the inner surface of the vessel member comprises the sensor or is connected to the sensor.
The sensor may be connected to a hydraulic reservoir connected to the inflatable portion, and the sensor may be configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
According to one embodiment, the implantable system further comprises at least one sensor configured to sense at least one physiological parameter of the patient. The physiological parameter of the patient could be one or more of: expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
According to one embodiment, the vessel member comprises an attachment device for attaching the vessel member to a portion of the body of the patient. The attachment device may be configured to attach the vessel member to a portion of the body of the patient comprising bone.
According to one embodiment, the vessel member can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel. The adjustable vessel member may thus comprise at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel. According to one embodiment, the implantable system according to any one of the embodiments may comprise a vessel member having an inner surface comprising at least one curvature configured to be placed in the direction of the length extension of the blood vessel, such that the inner surface can follow a curvature of the blood vessel.
According to one embodiment, the inner surface of the vessel member comprises at least a first and a second portion being angled relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the inner surface of the vessel member comprises at least a first and a second portion being displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
According to one embodiment, the vessel member comprises a first part and a second part, and the first and second parts are adapted to be connected to each other to form at least a portion of the vessel member.
According to one embodiment, the first and second parts are adapted to be assembled such that the joint between the first and second parts is more parallel than perpendicular to the direction of the length extension of the blood vessel.
According to one embodiment, the vessel member comprises an opening for accommodating at least one branching blood vessel connected to the blood vessel, and/or a recess for accommodating at least one branching blood vessel connected to the blood vessel.
According to one embodiment, the at least one opening comprises at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel. The through-hole has a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2, preferably in the range 16mm2 - 100mm2.
According to one embodiment, the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm. The recess may comprise at least one furrow adapted to accommodate at least one branching blood vessel.
According to one embodiment, the implantable system further comprises a remote unit connected to the vessel member. A major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
According to one embodiment, the remote unit comprises at least a portion of the operation device, and the implantable system may further comprise a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
According to one embodiment, the vessel member comprises at least part of the operation device. The part of the operation device comprised in the vessel member may comprise a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel. According to one embodiment, the receiving portion is configured to receive a linear mechanical force and according to an alternative embodiment, the receiving portion is configured to receive a rotating mechanical force. The transmission may be configured to transform the received rotating mechanical force into a liner mechanical force.
According to one embodiment, the transmission comprises a gear system configured to reduce the velocity and increase the force of the received mechanical force.
The portion of the operation device placed in the remote unit may comprise an electrical motor which may be connected to, or have an integrated gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
According to one embodiment, the portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel.
According to one embodiment, the transmission may comprise at least one hydraulic cylinder.
According to one embodiment, the portion of the operation device placed in the vessel member may comprise a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
According to one embodiment, the portion of the operation device placed in the remote unit may comprise at least one operable valve for controlling a flow of hydraulic fluid.
According to one embodiment, the portion of the operation device placed in the remote unit may comprise at least one hydraulic pump and may comprise a hydraulic reservoir for holding a hydraulic fluid and may comprise an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
The remote unit may further comprise an energy storage unit for directly or indirectly energizing the implantable system.
The remote unit may further comprise the implantable controller and the implantable controller may comprise a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
According to one embodiment, the implantable system further comprises at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member.
According to one embodiment, the implantable system further comprises a housing configured to enclose the remote unit.
A first portion of the housing may be made from titanium and a second portion of the housing may be made from a ceramic material.
The portion of the housing made from a ceramic material may comprise at least one coil embedded in the ceramic material. According to one embodiment, the remote unit comprises a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, and a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion. The first, second and third planes are parallel to each other, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes. The first portion may be detachably connected to the connecting portion, and the second portion may be detachably connected to the connecting portion.
According to a one aspect of the present inventive concept there is provided a device for treating an aneurysm of a mammal patient. The device comprises an operable implantable member adapted to be placed in connection with the blood vessel having the aneurysm. The implantable member is adapted to partially enclose the circumference of the aneurysm in a cross section such that at least one branch arising from the artery is not enclosed by the implantable member. This enables for an aneurysm treating device that is better adapted to the natural vessel structure at the site of the aneurysm. By not enclosing healthy parts, e.g. branches, of the vessel not having the aneurysm, the disruptions of their physiological functions are also kept to a minimum.
According to another aspect of the present inventive concept there is provided an implantable member that is adapted to be placed in connection with an aneurysm located at the aorta.
According to another aspect of the present inventive concept there is provided an implantable member that comprises an attachment device. The attachment device attaches the implantable member to a portion of the body of the patient. This enables support to the implantable member, both in the direction of the elongation of the blood vessel as well as in perpendicular, radial directions.
According to one embodiment, the implantable member is Y -shaped, thus, enabling for a better fit at Y -shaped vessel portions such as the aorta bifurcation.
The implantable member may comprise at least two segments adapted to be assembled. Having multiple segments adapted to be assembled ensures that the aneurysm treating device is adaptable with respect to the size, placement of the aneurysm and number of branches. Each segment may have a height parallel to the direction of the blood flow being 0.1cm to 5cm.
According to another aspect, two segments at least partially encloses different circumferences of the blood vessel. This allows for an aneurysm treating device that can be adapted according to the different circumferences of the aneurysm.
According to another aspect, the aneurysm treating device further comprises a first segment of the at least two segments, and a second segment of the at least two segments, wherein the first segment comprises a first attachment device, and the second segment comprises a second attachment device.
According to another aspect, a plane of the inner surface of the at least two segments is adapted to have an angle in relation to a center axis of the blood vessel in the direction of the blood flow.
According to another aspect, a plane of the inner surface of a first segment of the at least two segments is adapted to have a first angle in relation to the center axis, and a plane of the inner surface of a second segment of the at least two segments is adapted to have a second angle in relation to the center axis, and the first and second angles are different.
According to another aspect, a first segment comprises at least one recess and a second segment comprises at least one protrusion, and the first segment is connectable to the second segment by the at least one protrusion being placed in the at least one recess.
According to another aspect, the at least two segments comprise grooves in the joint between the at least two segments, adapted to fit the grooves of the at least one other segment.
According to another aspect the at least two segments comprise at least one bayonet mount adapted to assemble the at least two segments.
According to another aspect, the joint between the at least two segments is adapted to be assembled by a jigsaw joint.
According to another aspect, the jigsaw joint comprises a recess or through hole adapted to receive a bendable member extending in a direction parallel to the direction of the blood flow.
According to another aspect the at least two segments are adapted to be assembled by connecting the at least two segments with at least one bendable member extending in a direction parallel to the direction of the blood flow and penetrating the at least two segments.
According to another aspect the at least one bendable member is adapted to penetrate the at least two segments through slots located at the at least two segments.
According to another aspect the slots located at a segment are adapted to be aligned with slots located at another segment when penetrated by the at least one bendable member. This enables for a secure connection between the segments. According to another aspect, each segment comprises at least two portions configured to be connected to each other for partially enclosing the aneurysm.
According to another aspect, the first portion comprises at least one recess and the second portion comprises at least one protrusion, and the first and second portions are adapted to be connected to each other by the at least one protrusion being placed in the at least one recess.
According to another aspect, the at least two segments are adapted to be assembled such that the joint between the at least two segments is more perpendicular than parallel to the direction of the blood flow.
According to another aspect, the at least two segments are adapted to be assembled such that the joint between the at least two segments is perpendicular to the direction of the blood flow.
According to another aspect, the at least two segments are adapted to be assembled such that the joint between the at least two segments is more parallel than perpendicular to the direction of the blood flow.
According to another aspect, the at least two segments are adapted to be assembled such that the joint between the at least two segments is parallel to the direction of the blood flow.
According to another aspect, each segment comprises at least one pivot joint, such that the segment can be at least partially opened for partially enclosing the aneurysm.
According to another aspect, the pivot joint comprises a hinge. These aspects enable for an implantable member that can be adjusted and customized depending on for example the number of branches arising from the vessel, the placement of the aneurysm and the size of the aneurysm.
According to another aspect, the implantable member comprises at least one opening adapted to receive at least one branch arising from a blood vessel.
According to another aspect, the distance between the opening and the at least one branch is between 0.1cm and 1cm.
According to another aspect, the at least one opening is annular.
According to another aspect, the at least one annular opening has a diameter of 0. 1cm to 1cm.
According to another aspect, the at least one annular opening has a diameter of 0. 1cm to 5cm.
According to another aspect, the at least one opening is rectangular.
According to another aspect, the at least one rectangular opening has a width perpendicular to the direction of the blood flow being 0.1cm to 1cm, and a height parallel to the direction of the blood flow being 0.1cm to 1cm.
According to another aspect, the at least one rectangular opening has a width perpendicular to the direction of the blood flow being 0.1cm to 5cm, and a height parallel to the direction of the blood flow being 0.1cm to 5cm.
According to another aspect, the at least one opening is a flexible slit.
According to another aspect, the implantable member is adapted to exert a pressure on the aneurysm. By applying a pressure, the aneurysm is kept from bursting.
According to another aspect, the implantable member is adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
According to another aspect, the device further comprises an implantable pump for increasing the pressure of a hydraulic fluid.
According to another aspect, the device further comprises an implantable motor mechanically connected to the implantable pump.
According to another aspect, the implantable member is connected to a valve.
According to another aspect, each segment of the implantable member is connected to a valve.
According to another aspect, the valve is adapted to be located inside the body.
According to another aspect, the valve is adapted to be located inside the abdominal cavity.
According to another aspect, the device further comprises a valve system configured to direct hydraulic fluid to at least one segment of the implantable member for exerting a hydraulic pressure on the aneurysm.
According to another aspect, the valve system is enclosed in a biocompatible enclosure or housing. The enclosure or housing could comprise a carbon-based material, a metallic material, and/or a ceramic material.
According to another aspect, the pressure exerted by each segment is individually adjustable. This enables for a customized aneurysm treating device that applies the right amount of pressure to the right places of the vessel and aneurysm.
According to another aspect, the device further comprises an implantable controller for controlling the pressure exerted by the implantable member.
According to another aspect, the device further comprises at least one sensor for sensing at least one physiological parameter of the patient, and wherein the sensor is connected to the controller.
According to another aspect, the physiological parameter is the blood pressure of the patient. By taking physiological parameters into account, the right amount of pressure can be calculated and applied at all times, regardless of the patient’s activities. By compensating for the activity of the patient, no unnecessary pressure is exerted on the aneurysm, and correspondingly, there is no risk of too little pressure being applied.
According to another aspect, the physiological parameter is related to the size of the aneurysm. This again ensures that no unnecessary pressure is applied to smaller aneurysms, and that enough pressure is applied to big aneurysms.
According to another aspect, the device further comprises an expandable hydraulic reservoir connected to the sensor and adapted to hold a fluid.
According to another aspect, the volume of the fluid is related to the growth rate of the aneurysm. By compensating for growth rate, the pressure can be increased if the aneurysm grows.
According to another aspect, there is provided a medical kit for treating an aneurysm of a blood vessel of a human or mammal patient, the blood vessel being adapted for a blood flow therethrough and having a substantially tube-shaped tissue having a length and an annular circumference in a cross section perpendicular to the direction of the blood flow, and the aneurysm being a balloon-like bulge on said blood vessel. The medical kit comprises a first implantable segment adapted to be placed in connection with the blood vessel having the aneurysm and partially enclose the circumference of the aneurysm, in said cross section, such that at least one branch arising from the artery is not enclosed by the implantable segment, and a second implantable segment, connectable to the first implantable segment, and being adapted to be placed in connection with the blood vessel having the aneurysm and at least partially enclose the circumference of the aneurysm.
A method of implanting an implantable system for handling an aneurysm in a blood vessel of a patient according to any one of the preceding embodiments is further provided. The method comprising making an incision in the body of the patient for accessing a vessel having an aneurysm, dissecting a portion of the vessel, and placing at least one vessel member according to any one of the embodiments herein in connection with or adjacent to the blood vessel.
The method may further comprise the step of connecting two or more parts for forming the vessel member.
The method may further comprise the step of placing at least one branching blood vessel in an opening or recess in the vessel member.
The method may further comprise the step of placing a remote unit connected to the vessel member at a distance exceeding 80mm from a major portion of the vessel member.
The method may further comprise the step of attaching the adjustable vessel member to a portion of the body of the patient. According to one embodiment, the step of placing at least one vessel member according to any one of the embodiments herein in connection with or adjacent to the blood vessel may comprise placing at least one vessel member according to any one of the embodiments herein in connection with or adjacent to the aortic arch.
Brief descriptions of the drawings
The invention will by way of example be described in more detail with reference to the appended drawings, which shows embodiments of the invention.
Fig. 1 shows a schematic view of the thoracic and abdominal aorta and its branches.
Fig. 2 shows a schematic view of the abdominal cavity and some of its soft tissue.
Fig. 3 shows the abdominal cavity of a patient when an implantable system for handling an aneury sm according to an embodiment has been positioned.
Fig. 4A shows a schematic, exploded view of a vessel member according to one embodiment.
Fig. 4B shows a schematic, exploded view of a vessel member according to one embodiment.
Fig. 4C shows a schematic, exploded view of a vessel member according to one embodiment.
Fig. 5A shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 5B shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 5C shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 5D shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 5E shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 5F shows a schematic, exploded view of a vessel member according to one embodiment.
Fig. 6A shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 6B shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
RECTIFIED SHEET (RULE 91) ISA/EP Fig. 6C shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 7A shows a schematic, exploded view of a vessel member according to one embodiment.
Figs. 7B and 7C shows enlarged details of the embodiment of the vessel member shown in fig. 7A.
Fig. 8A shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 8B shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9A shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9B shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9C shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9D shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9E shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9F shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 9G shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 10A shows a schematic, cross-sectional view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 10B shows a schematic, cross-sectional view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 11 shows a schematic, cross-sectional view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 12 shows a schematic, cross-sectional view of a vessel member when it is placed on a blood vessel having an aneurysm.
Fig. 13A shows a schematic view of a vessel member and an attachment device according to one embodiment.
Fig. 13B shows a schematic view of a vessel member and an attachment device according to one embodiment. Fig. 13C shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm and fixated to the spine of the patient.
Fig. 14 shows a schematic view of a vessel member when it is placed on a blood vessel having an aneurysm and fixated to soft tissue of the patient.
Fig. 15A shows a schematic, exploded view of a vessel member according to one embodiment.
Fig. 15B shows an enlarged detail of the embodiment of the vessel member shown in fig. 15A.
Fig. 16A shows a schematic view of a kit of vessel members according to one embodiment.
Figs. 16B and 16C shows further elements of a vessel member compatible with the kit shown in fig. 16A.
Fig. 17 shows a view of a patient’s thorax and abdomen, when an implantable system for handling an aneurysm has been implanted. The implantable system comprising a vessel member having been placed on the aorta at the aortic arch, and a remote unit connected to the vessel member and fixated to muscle tissue of the abdominal wall of the patient.
Fig. 18A shows a lateral view of a patient’s thorax when a vessel member has been placed on the aorta at the aortic arch and fixated to the posterior side of the sternum.
Fig. 18B shows a lateral view of a patient’s thorax when a vessel member has been placed on the aorta at the aortic arch and fixated to the anterior side of the sternum.
Fig. 18C shows a lateral view of a patient’s thorax when a vessel member having a first and second segment has been placed on the aorta at the aortic arch with each segment fixated at different positions on the posterior side of the sternum.
Fig. 18D shows a lateral view of a patient’s thorax when a vessel member having a first and second segment has been placed on the aorta at the aortic arch and fixated at a single position on the posterior side of the sternum.
Fig. 18E shows a lateral view of a patient’s thorax when a vessel member has been placed on the aorta at the aortic arch and fixated to the posterior side of one rib.
Fig. 19A shows a schematic view of a patient’s aortic arch, when a vessel member comprised of three separate parts has been placed around the aorta at the artic arch.
Fig. 19B shows a schematic view of a patient’s aortic arch when a vessel member has been placed around the aorta at the artic arch.
Fig. 19 shows a schematic view of a patient’s aortic arch, when a vessel member comprised of three separate parts have been placed around the aorta at the artic arch.
Fig. 20A shows a schematic view of a vessel member or a segment of a vessel member.
Fig. 20B shows a schematic cross-sectional view of a vessel member or a segment of a vessel member.
Fig. 20C shows a detailed cross-section of the vessel member shown in fig. 20B. Fig. 21 shows a schematic view of a vessel member or a segment of a vessel member.
Fig. 22 shows a schematic cross-sectional view of a vessel member or a segment of a vessel member.
Fig. 23A shows a schematic view of a patient’s aortic arch, when a vessel member comprised of five segments have been placed around the aorta at the artic arch.
Fig. 23B shows an isolated view of the vessel member comprised of five segments shown in fig. 23A.
Fig. 24A shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising a vessel member placed on a blood vessel having an aneurysm.
Fig. 24B shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising a vessel member placed on a blood vessel having an aneurysm.
Fig. 25A shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising a mechanically adjustable vessel member placed on a blood vessel having an aneurysm.
Fig. 25B shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising a vessel member placed on a blood vessel having an aneurysm and a remote unit fixated to muscle tissue of the patient.
Fig. 25C shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising a mechanically adjustable vessel member placed on a blood vessel having an aneurysm.
Fig. 25D shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising an electrically adjustable vessel member placed on a blood vessel having an aneurysm.
Fig. 25E shows a schematic view of an implantable system for handling an aneurysm, the implantable system comprising a vessel member configured to electrically stimulate the blood vessel having an aneurysm.
Fig. 26A shows a cross-sectional view of an implantable remote unit for powering a vessel member with hydraulic force.
Fig. 26B shows a cross-sectional view of an implantable remote unit for powering a vessel member with hydraulic force.
Fig. 27 shows an exploded cross-sectional view of an implantable remote unit for powering a vessel member with hydraulic force.
Fig. 28A shows a detailed cross-sectional view of a first unit of an implantable remote unit for powering a vessel member with hydraulic force.
Fig. 28B shows a detailed cross-sectional view of a first unit of an implantable remote unit for powering a vessel member with hydraulic force. Fig. 28C shows a detailed cross-sectional view of a first unit of an implantable remote unit for powering a vessel member with hydraulic force.
Fig. 28D shows a detailed cross-sectional view of a first unit of an implantable remote unit for powering a vessel member with hydraulic force.
Figs. 29A - 3 IB shows alternative embodiments of connecting portions for an implantable remote unit.
Fig. 32 shows, schematically, a kit of components forming an implantable remote unit.
Fig. 33 shows a detailed cross-sectional view of an embodiment of an implantable remote unit for powering a vessel member.
Fig. 34 shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 35 shows a perspective elevated view from the right of a portion of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 36 shows a perspective elevated view from the right of a portion of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 37A shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 37B shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 37C shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 37D shows a cross-sectional plain side view of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 38A shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 38B shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 38C shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 38D shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Figs. 38E - 38Q shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 39 shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 40 shows a plain top view of an embodiment of an implantable remote unit for powering an implantable system. Figs. 41 and 42 shows, schematically, plain top views of two embodiments of implantable remote units for powering implantable system.
Figs. 43A - 43C illustrates three stages of insertion and fixation of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 44 shows a detailed cross-sectional view of an embodiment of an implantable remote unit for powering an implantable system.
Fig. 45A shows, schematically, a portion of an implantable remote unit for powering an implantable system.
Fig. 45B shows, schematically, a portion of an implantable remote unit for powering an implantable system.
Fig. 45C shows, schematically, a portion of an implantable remote unit for powering an implantable system.
Fig. 46A shows a plain view of an embodiment of a hydraulic pump for operating an implantable medical device.
Fig. 46B shows a side view of the hydraulic pump of fig. 46A, for operating an implantable vessel member.
Fig. 46C shows a plain view of an embodiment of a hydraulic pump for operating an implantable medical device.
Fig. 47A shows a top view of a gear system for an implantable system.
Fig. 47B shows a partially sectional side view of a gear system for an implantable system.
Fig. 48 shows a sectional side view of an embodiment of a hydraulic pump for an implantable medical device.
Fig. 49A shows a sectional side view of an embodiment of a hydraulic pump for an implantable system.
Fig. 49B shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 49C shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 49D shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 49E shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 49F shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 49G shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system. Fig. 49H shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 50 shows an elevated perspective view from the left of an embodiment of a hydraulic pump for an implantable system.
Fig. 51A shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
Fig. 5 IB shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
Fig. 51C shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
Fig. 5 ID shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
Fig. 5 IE shows an embodiment of a sensor for sensing the pressure in a hydraulic portion of the implantable system.
Fig. 52 shows an overview of a system for handling an aneurysm on a blood vessel of a patient, including an electrode arrangement for electrical stimulation of a tissue portion of the blood vessel.
Fig. 53A shows an embodiment of an electrode arrangement, for inclusion in an implantable system.
Fig. 53B shows an embodiment of an electrode arrangement, for inclusion in an implantable system.
Fig. 53C shows an embodiment of an electrode arrangement, for inclusion in an implantable system.
Fig. 53D shows an embodiment of an electrode arrangement, for inclusion in an implantable system.
Fig. 54 shows an embodiment of a stimulation cycle for electrical stimulation of a tissue wall.
Fig. 55 shows an embodiment of a stimulation cycle for electrical stimulation of a tissue wall.
Fig. 56 is a block diagram schematically describing the function of the system for electrical stimulation of a tissue wall of the patient.
Figs. 57A - 57N show embodiments and describes various functions of an implantable controller for controlling the implantable system and external devices used for control and communication with the implantable system for handling an aneurysm of the patient.
Fig. 570 shows an elevated perspective view from the left of a housing unit.
Fig. 57P shows a plain view from the left of a housing unit.
Fig. 57Q shows an elevated perspective view from the left of a housing unit. Fig. 57R shows a plain view from the left of a housing unit.
Fig. 57S shows a system overview of an external device comprising a housing unit and a display device in wireless communication with an implanted medical device.
Figs. 58A - 58C describes the reaction that takes place when a blood vessel is damaged.
Fig. 59 shows an implantable medical device comprising an implant surface and a coating arranged on the surface.
Fig. 60 shows an exemplary implantable medical device comprising an at least partially hollow implant body.
Fig. 61 shows an exemplary implantable medical device with a surface.
Figs. 62a and 62b shows different micropattems on the surface of an implant.
Detailed description
The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness, and fully convey the scope of the invention to the skilled person. All of the embodiments disclosed could be combined unless doing so is clearly contradictory.
Generally, an implantable system comprising a vessel member for handling an aneurysm of a patient is described herein. Aneurysm could principally occur on all blood vessels, but predominantly occurs on the and on the arteries leading to the brain. Handling an aneurysm could mean monitoring the state or expansion of the aneurysm, supporting the blood vessel by applying an external withholding force or exerting an external pressure on the blood vessel for countering the expansion of the aneurysm. The implantable system may thus be configured to monitor an expansion of an aneurysm and/or the state of the blood vessel (such as tissue thickness or saturation). The implantable system may be configured to communicate the expansion of an aneurysm and/or the state of the blood vessel to an external device operated by the patient and/or a health professional. The implantable system may be configured to take action to counter the expansion by initiating or increasing the withholding force or pressure applied to the outside of the blood vessel. Such action may be taken by the implantable system autonomously, or in response to a control signal sent from an external device by the patient, health professional or an automated external system.
The vessel member could be a passive device, or an active, adjustable vessel member and the implantable system could comprise an operation device for operating the adjustable vessel member. The operation device could be an electrical operation device for operating an electrically adjustable vessel member, a mechanical operation device for operating a mechanically adjustable vessel member, or a hydraulic operation device for operating a hydraulically adjustable vessel member. The operation device could be configured to be powered by means of wireless energy transfer from the outside of the body of the patient, or by means of an implantable battery adapted to store electrical energy in the body of the patient. The operation device may comprise an electrical motor for transferring electrical energy to mechanical work. The electrical motor could for example be an alternating current (AC) electrical motor, such as a three-phase electrical motor (which may be controlled using variable-frequency drive), a direct current (DC) electrical motor, a linear electrical motor, an AC or DC axial electricalv motor, a piezo-electric motor, a bimetal motor, or a memory metal motor, and the electrical motor may be connected to one or more gear systems for altering the velocity and/or force/torque and/or direction of the supplied force. The system may additionally comprise a controller for controlling the operation device and for communicating with portions of the implantable system and/or external units. The data communication with external units could comprise control signals from the external unit for controlling the implantable member or could comprise feedback signals from the implantable member, which for example could be sensor parameters such as physiological or physical sensor parameters related to the status of the body of the patient, or physical or functional parameters related to the status of the implantable member.
The adjustable vessel member in the embodiments described herein could all be adapted to exert a pressure in the range between the systolic and the diastolic blood pressure of the patient, such that a counter force is created without hampering the blood flow in the tissue wall of the blood vessel. The systolic blood pressure in a healthy patient should be below 120 mm Hg, and the diastolic blood pressure should be below 80 mm Hg. This means that the vessel member may be adapted to exert a pressure on the blood vessel in the range 80 mm Hg - 120 mm Hg, preferably in the range 90 mm Hg - 110 mm Hg.
A physical or functional parameter of the implantable system could throughout the description be an electrical parameter, such as voltage, current or impedance, a parameter related to a fluid, such as pressure, flow rate, temperature, volume, weight or viscosity. The physical or functional parameter could be related to energy received at the implantable system, energy delivered to the body of the patient, fluid received in the implantable system or delivered to a vessel member, force exerted on the body of the patient or time elapsed since an action performed in relation to the body of the patient.
Fig. 1 shows the aorta 20 and its branches. The aorta 20 is the main and largest artery in the human body, originating from the left ventricle of the heart, first ascending cranially into the aortic arch 30 (arch of the aorta, or transverse aortic arch), which is the essentially U-shaped portion of the aorta 20 between the ascending and descending aorta 20. After the aortic arch 30, the aorta 20 descends down into the abdomen, where it splits into two smaller arteries, the common iliac arteries 31,31’. The upper portion of the aorta 20 is called the thoracic aorta TA (or thoracic portion of the aorta). The thoracic aorta TA is a part of the aorta 20 supplying blood to a portion of the thorax. The thoracic aorta TA runs from the heart to the diaphragm D, where it descends into the abdomen though the aortic hiatus 32, which is the orifice in the diaphragm D through which the aorta 20 travels from the thorax to the abdomen, at the level of the T12 vertebra 15. The arteries supplying the organs of the thorax arise from the thoracic aorta TA in branches. If the thoracic aorta TA is travelled from the heart, the illustrated branch most proximal to the heart is the Brachiocephalic artery 29, which is placed at the aortic arch 30 and bifurcates into the right carotid artery 29” which supplies the head and neck, and the right subclavian artery 29’ which supplies the right arm. The next branch is the left common Carotid artery 28 which is also placed at the aortic arch 30 and also supplies the head and neck. The left Subclavian artery 27, also placed at the aortic arch 30 supplies the left arm.
The Intercostal arteries 21 supply the area between the ribs ("costae"), called the intercostal space. The Bronchial arteries 26 supply the lungs. Although there is much variation, there are usually two bronchial arteries 26 that run to the left lung, and one to the right lung. The Mediastinal arteries 25 supply the lymph glands and loose areolar tissue in the posterior mediastinum and the Esophageal arteries 24 supplies the esophagus. The Pericardial arteries 23 supply the fibrous pericardium and the Phrenic arteries 22 supply the diaphragm D.
The aorta 20 then continues downward as the abdominal aorta AA (or abdominal portion of the aorta) from the diaphragm D to the aortic bifurcation 2. The abdominal aorta AA is the part of the aorta 20 supplying blood to the abdominal cavity. It begins at the aortic hiatus 32, which is the orifice in the diaphragm D through which the aorta 20 travels between the thorax and the abdomen, at the level of the T12 vertebra 15. The abdominal aorta AA 15 cm inferior with the aortic bifurcation 2 at the level of the L4 vertebra 19, at which location the width of the aorta 20 is approximately 2-3 centimeters.
The arteries supplying the abdominal organs arise from the abdominal aorta 20 in branches being visceral (pertaining to the internal organs) or parietal (relating to the walls of the abdominal cavity), and paired or unpaired. The paired parietal inferior phrenic arteries 3, 3' stem from the abdominal aorta 20 at T12 15 and supply the inferior surface of the diaphragm D. The visceral celiac trunk 4 is unpaired and also emerges at T12 15. It divides into three branches (left gastric 6, splenic 7 and common hepatic arteries 5) and supplies the stomach, liver, pancreas, spleen and a part of the small intestine.
At LI 16, the visceral, unpaired superior mesenteric artery 8 arises which supplies a large part of the intestines. The visceral suprarenal arteries 9, 9' are paired, located at LI 16 and supplies the adrenal glands above the kidneys. Between LI 16 and L2 17 the visceral renal arteries 36, 36' emerge. They are paired and supply the kidneys. The paired visceral gonadal arteries 11, 11 ' (called testicular arteries and ovarian arteries in males and females respectively) arise at L2 17 and extend into the scrotum in males, and pelvis in females. At L3 18 the visceral inferior mesenteric artery 12 is located, which is unpaired and the final major branch of the abdominal aorta 20. It supplies the distal part of the large intestine, and branches out into the left colic, sigmoidal and superior rectal arteries. The parietal lumbar arteries 33 arise horizontally in four pairs from the lumbar region (the region pertaining to the abdominal section between the diaphragm and torso) of the aorta 20 and support the abdominal wall. At the aortic bifurcation 2 at L4 19, the abdominal aorta AA splits into the common iliac arteries 31,31 ’ which supply the inferior part of the abdominal wall as well as the pelvis and lower limbs. From the most inferior part of the abdominal aorta AA, the median sacral artery 13 emerges. It is unpaired and supplies the sacrum and coccyx.
Fig. 2 shows the aorta 20 in the abdominal cavity with a bulging aneurysm 50 above the aorta bifurcation. Fig. 2 further shows some of the abdominal soft tissue that the vessel member in any of the embodiments herein may be attached to. The muscles of the posterior abdominal wall: psoas minor 42, psoas major 42’, quadratus lumborum 43, iliacus 44, and the muscular portion of the diaphragm 45, may all work as attachment areas for the vessel member. The tendinous structure right crus 41 and left crus 41 ’ are two other options for attaching the vessel member. Further, the parietal peritoneum 47 attached to the abdominal wall is another possible attachment area, along with the transversalis fascia 46.
Fig. 2 further shows an aneurysm 50 on the aorta 20, which is illustrated as a balloon-like bulge on the aorta 20. The bulge extends radially R, perpendicular to the length extension LE of the aorta, being the direction of the blood flow in the aorta. In the abdomen, the aorta 20 extends in a cranial-caudal direction, which thereby if the direction of the length extension LE of the abdominal aorta 20.
Fig. 3 shows the abdominal cavity of a human patient when an implantable system for handling an aneurysm in a blood vessel of a patient has been implanted. The system comprises a vessel member 100 positioned on the abdominal portion of the aorta 20, such that the vessel member 100 partially encloses the aorta in a region of the aneurysm 50. The aorta 20 is a blood vessel having a substantially tube-shaped tissue having a length and an annular circumference in a cross-section perpendicular to the direction of the blood flow and perpendicular to the length extension LE of the aorta 20.
In the embodiment shown in fig 3, the vessel member 100 has an opening 110. In the crosssection of the aorta 20 at the opening 110, the vessel member 100 only partially enclose the circumference of the aorta 20, at the aneurysm 50, thus enabling a branching blood vessel connected to the aorta 20, in this embodiment being the visceral inferior mesenteric artery 12, to pass though the vessel member 100.
The vessel member 100 in fig 3. is in the embodiment of fig. 3 connected to and fixated by a connection 650 to a remote unit 600, which in turn is fixated to muscular layers of the abdominal wall (Further described with reference to fig. 17). In the embodiment shown in fig. 3, the connection 650 comprises a semi-rigid attachment device configured to support the vessel member 100 both in the direction of the length extension LE of the aorta 20, as well as in perpendicular, radial directions.
In the embodiment shown in fig. 3, the vessel member 100 comprises several segments 120a - 120e assembled along the direction of the length extension LE of the aorta 20, and the connection/attachment device 650 is in this embodiment fixedly connected to one of the segments 120c, which in turn connects to and stabilizes the segments, directly connecting to segment 120c, 120e and indirectly connecting to segments 120a and 120b. In alternative embodiments, it is however conceivable that the connection/attachment device 650 branches off into several attachment devices, each connecting to a segment of the vessel member, such as for example shown in figs. 15A,19A,24B. In alternative embodiments it is also plausible that the vessel member consists of only one segment, such as shown in for example figs. 8 - 9D.
The connection/attachment device 650 is in the embodiment shown in fig. 3 connected to the abdominal wall AW of the patient, which includes the muscular tissue, such as e.g. the rectus abdominis, fascia of the abdominal wall as well as the cutaneous and subcutaneous tissue. The connection/attachment device 650 is in the embodiment of fig. 3 fixated by means of two portions of the remote unit 600 clamping a portion of the abdominal wall and thus fixating the remote unit 600 (this is described in further detail with reference to fig. 17). It is in alternative embodiments conceivable that the fixation is performed or supported by sutures or staplers or by means of fixation facilitated by the in-growth of fibrotic tissue in e.g. a mesh structure connected to the connection/attachment device.
The connection/attachment device 650 in the embodiment shown in fig. 3 is made from a semi-rigid polymer-based material which enables some movement between the remote unit 600 and the vessel member 100 which is necessary to compensate both for the general movement of the patient’s body as well as for the pulsation of the aorta 20 and the patient’s respiration. In alternative embodiments, such as for example shown in figs. 13B and 13C, the attachment device may comprise a metallic or composite material, which could be elastic or flexible by means of an elastic element such as a spring.
In embodiments in which the vessel member 100 is an adjustable vessel member, the connection/attachment device 650 may comprise elements for transferring force, electrical energy or communication signals, i.e. the connection/attachment device 650 may e.g. comprise a fluid conduit configured for transferring hydraulic fluid, an electrical lead for transferring electrical energy or communications signals or a mechanical force transferring member for transferring kinetic energy.
Again, in fig. 3 the connection/attachment device 650 is attached to the abdominal wall. In alternative embodiments it could very well be attached to other portions of the body, such as bone, which can be seen in fig. 13C where the attachment device is attached to the spine. Alternatively, the attachment device could be attached to soft tissue, such as muscles, fascia, tendons, ligaments, connective tissue or fibrous tissue in vicinity to the blood vessel having the aneurysm.
Although the embodiment in fig. 3 shows the vessel member 100 being placed at the aorta 20, the vessel member 100 could be placed at other blood vessels, such as the gastric, renal, iliac and brachial vessels. Alternatively, the vessel member may be placed at other locations of the aorta, such as the aorta bifurcation 2, in which case the implantable member is Y -shaped, such as described in fig. 8B or at the aortic arch such as described with reference to figs. 18A - 23B in which case the vessel member is suitably adapted.
Fig. 4A shows an implantable system for handling an aneurysm in a blood vessel of a patient according to one embodiment. The implantable system comprises a vessel member 100 configured for enclosing a portion of the blood vessel in a region of an aneurysm, for monitoring, withholding and/or exerting pressure on the aneurysm, for preventing the aneurysm from rupturing or bursting. The vessel member 100 comprises a first and a second segment 120a, 120b, each having an inner surface 12 la, 12 lb comprising a first and a second portion 123a, 123b. The first and second portions 123a and 123b are configured to face an outer surface of the blood vessel, when the implantable vessel member 100 is implanted. In the embodiment shown in fig. 4A, the first segment 120a comprises the first portion 123a, and a second segment 120b comprises the second portion 123b. The first and second segments 120a, 120b are annular segments configured to be connected to each other in the direction of the length extension LE of the blood vessel, for creating the connected vessel member 100 configured to follow a shape of the blood vessel and/or the aneurysm. The first segment 120a comprises a first connection interface 124a positioned along an annular axial area facing a corresponding annular axial area of the second segment 120b. The first connection interface 124a is a connection interface in the form of a connection protrusion extending downwards in fig. 4A, along the entirety of the annular axial area. The connection protrusion of the first segment 120a is configured to mate with and connect to a connection interface 125b in the form of a connection recess facing upwards in fig. 4A, along the entirety of the corresponding annular axial area of the second segment 120b.
In the embodiment of fig. 4A, the first and second portions 123a, 123b are angled relative to each other, for enabling the inner surface of the connected vessel member 100 to follow a curvature of the blood vessel in the direction of the length extension LE of the blood vessel.
In the embodiment shown in fig. 4A, the first segment 120a has a cylindrical inner surface 121a, such that the upper most diameter d 1 ’ of the cylindrical inner surface 121 a of the first segment 120a is the same as the lower most diameter dl” of the cylindrical inner surface 121a of the first segment 120a. The second segment 120b, however, has an inner surface 121b with a conical frustum shape, such that the upper most diameter d2’ of the inner surface 121b of the second segment 120b is larger than the lower most diameter d2” of the inner surface 121b of the second segment 120b. As such, the first segment 120a of the vessel member 100 comprises a first enclosing cross-sectional area 126a perpendicular to the direction of the length extension LE of the blood vessel, for enclosing one portion of the blood vessel, and the second segment 120b of the vessel member 100 comprises a second enclosing cross-sectional area 126b perpendicular to the direction of the length extension LE of the aorta, for enclosing another portion of the blood vessel. The second enclosing cross-sectional area 126b is smaller than the first enclosing cross-sectional area 126a, such that the vessel member 100 is adapted to enclose an aneurysm having a larger cross-sectional area in the region to be enclosed by the first segment 120a and a smaller cross- sectional area in the region to be enclosed by the second segment 120b.
In the embodiment shown in fig. 4A, the first and second segments 120A,120B, when assembled, cover a distance of 5mm - 100mm of the blood vessel, more precisely, a distance of 10mm - 60mm of the blood vessel in the direction of the length extension LE of the blood vessel.
In the embodiment shown in fig. 4A, the first and second segments 120A,120B are adapted to be assembled such that the joint between the first and second segments 120A,120B is more perpendicular than parallel to the direction of the length extension LE of the blood vessel, and in fig. 4A the joint between the first and second segments 120A,120B is substantially perpendicular to the direction of the length extension LE of the blood vessel.
In the embodiment shown in fig. 4A, the first segment 120a has a length in the range 3mm - 30mm and the second segment 120b has a length in the range 3mm - 30mm. More specifically, the first segment 120a has a length in the range 3mm - 20mm and the second segment 120b has a length in the range 3mm - 20mm.
Fig. 4B shows a vessel member 100 in an embodiment similar to the embodiment shown in fig. 4A, with the difference that the second segment 120b in fig. 4B comprises a first and second part 127a, 127b adapted to be connected to each other to enclose a portion of the blood vessel. The first and second parts 127a, 127b are adapted to be connected to each other such that the joint between the first and second parts (127a, 127b) is substantially parallel to the direction of the length extension LE of the blood vessel and to the direction of the blood flow. In the embodiment shown in fig. 4B, connecting surfaces 128’, 128” of the first and second parts 120a, 120b are connected by means of the first and second parts 127a, 127b in turn being connected to the first segment 120a, by means of the connection interface 124a, 125b between the first and second segments 120a, 120b. However, in alternative embodiments, it is equally conceivable that the first and second parts 127a, 127b are connected to each other by means of a mating joint, for example comprising recesses and protrusions, in a similar manner as the joint between the first and second segments 120a, 120b.
Fig. 4C shows a vessel member 100 in an embodiment similar to the embodiment shown in fig. 4A, with the difference that the first segment 120a can be partially opened for being introduced over the blood vessel. The first segment 120a in the embodiment of fig. 4C comprises at least one pivot joint 130 for enabling the segment 120a to be partially opened for being introduced over the blood vessel. In the embodiment of fig. 4C, the pivot joint comprises an elastic material, such as a biocompatible silicone or polyurethane material. It is however equally conceivable that the joint comprises a hinge-like structure. In the embodiment shown in fig. 4C, the connecting surfaces 128’ of the first segment 120a are connected by means of the first segment 120a in turn being connected to the second segment 120b, by means of the connection interface 124a, 125b between the first and second segments 120a, 120b. However, in alternative embodiments, it is equally conceivable that the connecting surfaces 128’ of the first segment 120a are connected to each other by means of a mating joint, for example comprising recesses and protrusions, in a similar manner as the joint between the first and second segments 120a, 120b.
Fig. 5A shows an embodiment of the vessel member 100 in which the vessel member comprises a first and second segment 120a, 120b configured to be connected for enclosing a portion of the aorta of the patient in a region of an aneurysm formed on the aorta 20 of the patient. The first segment 120a has an inner surface 121a and the second segment 120b has an inner surface 121b. The inner surfaces 12 la, 12 lb of the first and second segments 120a, 120b forms a first and second portion of the combined inner surface 121a, 121b of the vessel member 100, which faces the outer surface of the portion of the aorta 20 enclosed by the vessel member 100. The combined inner surface 12 la, 12 lb of the vessel member 100 has a curvature cl with a radius rl, in the direction of the length extension LE of the aorta 20, and configured to follow the curvature of the aneurysm 50 of the aorta 20. The first segment 120a is annular and encircles the aorta 20. At one enclosing cross-sectional area 126a, the inner surface 121a of the encircling first segment 120a forms a circle with a radius r2, i.e. the curvature c2 of the circle having the radius r2. As such, a first curvature cl having a first radius rl is configured to follow a curvature of the aorta 20 in the direction of the length extension LE of the aorta 20, and a second curvature c2 is configured to follow a curvature of the circumference of the aorta 20, in a cross-sectional plane perpendicular to the length extension LE of the aorta 20. In the embodiment shown in fig. 5A, the first radius rl is larger than the second radius r2, more specifically, the first radius rl is more than 2 times the second radius r2. In the embodiment shown in fig. 5 A, the first radius rl is in the range 12mm - 45mm, more specifically in the range 15mm - 40mm, and even more specifically in the range 20mm - 40mm. In the embodiment shown in fig. 5 A, the second radius r2 is in the range 3mm - 25mm, more specifically in the range 4mm - 15mm, and even more specifically in the range 6mm - 12mm. The opening 110 has a cross sectional area 129, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
In the embodiment shown in fig. 5 A, the first, upper segment 120a is configured to completely encircle a first portion of the aorta, whereas the second, lower segment 120b is configured to only partially encircle the aorta 20, as the lower segment 120b comprises an opening 110 configured to accommodate at least one branching blood vessel. The opening in fig. 5A is in the form of the second, lower segment 120b having a discontinuous circumference such that a square-shaped opening 100 is formed in the lower segment 120b of the vessel member 100. The distance dl between an edge of the at least one opening 110 and the at least one branching blood vessel 1 connected to the aorta 20 is between 1mm and 10mm, more specifically between 2mm and 7 mm.
The branching blood vessel 1 connected to the aorta 20 could be one of the Intercostal arteries, the Bronchial arteries, the Mediastinal arteries, the Esophageal arteries, the Pericardial arteries, the Phrenic arteries, the Celiac trunk, the Suprarenal arteries, the Renal arteries, the Mesenteric arteries, the Gonadal arteries, and the Lumbar arteries.
Fig. 5B shows an embodiment of the vessel member 100 similar to the embodiment shown in fig. 5A, the difference being that in the embodiment of fig. 5B, the vessel member further comprises a third segment 120c comprising a third connection interface 125c, in the form of a upwards facing connection recess, configured to mate with a downwards facing connection protrusion of the second segment 120b. As such, the first, second and third segments (120a, 120b, 120c) can be connected to each other for creating the vessel member 100 configured to follow the shape of the aneurysm 50 of the aorta 20 in the direction of the length extension LE of the aorta. The first segment 120a of the vessel member 100 is configured to completely encircle the aorta, whereas the second segment 120b comprises the opening 110 for accommodating at least one branching blood vessel 1 connected to the aorta 20, and the third segment 120c of the vessel member 100 is configured to completely encircle the aorta 20. The uppermost portions of each of the first, second and third segments 120a, 120b, 120c each comprises an enclosing cross-sectional area 126a, 126b, 126c configured for the cross-sectional area of the aorta 20 at that particular portion. In the embodiment shown in fig. 5B, the second enclosing cross-sectional 126b area is larger than the first enclosing cross-sectional area 126a and the third enclosing cross-sectional 126c area is larger than the second enclosing cross-sectional area 126b, and as such the vessel member 100 is adapted for enclosing an aneurysm having an increasing diameter or cross-sectional area.
Fig. 5C shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5B. The difference in relation to the embodiment shown in fig. 5B is that the opening 110 in fig. 5 C is an annular though-hole which has a larger cross-sectional area than the square-shaped opening in the segment of fig. 5B. The opening 110 has a cross sectional area 129, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
In the embodiment shown in fig. 5 A, the first, upper segment 120a is configured to completely encircle a first portion of the aorta, whereas the second, lower segment 120b is configured to only partially encircle the aorta 20, as the lower segment 120b comprises an opening 110 configured to accommodate at least one branching blood vessel. The opening in fig. 5A is in the form of the second, lower segment 120b having a discontinuous circumference such that a square-shaped opening 100 is formed in the lower segment 120b of the vessel member 100. The distance d2 between the annular edge of the through-hole and the branching blood vessel 1 connected to the aorta 20 is between 3mm and 10mm and the diameter of the annular through hole is in the range 8mm - 22mm, more specifically in the range 10mm - 18mm, i.e. the annular though-hole has a cross sectional area 129, in a plane perpendicular to the radius of the aorta 20, in the range 50mm2 - 380mm2, more specifically in the range 78mm2 - 254mm2.
In alternative embodiments, the opening could have an equal cross sectional area but have a different shape, such as an oval or square shape.
In the embodiment of fig. 5C, the opening is comprised in the first, second and third segments 120a, 120b, 120c. In alternative embodiments it is however conceivable that the opening is comprised in only two segments, such as in the first and second segment, or in the second and third segments.
The annular through-hole forms a portion of the first, second and third segments 120a, 120b, 120c, and as such, the joints between the first and second segment 120a, 120b and between the second and third segments 120b, 120c are intersected by the annular through-hole.
Fig. 5D shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5C. However, in the embodiment of fig. 5D, the vessel member additionally comprises a fourth and fifth segment 120d,120e, where the fourth segment 120d is connectable to the third segment 120c in the same way as the first, second and third segments 120a, 120b, 120c are connected, and the fifth segment 120e is connectable to the fourth segment 120d in the same way.
The upper most portion of the first segment 120a comprises a first enclosing cross- sectional area 126a, the upper most portion of the second segment 120b comprises a second enclosing cross-sectional area 126b, the upper most portion of the third segment 120c comprises a third enclosing cross-sectional area 126c, the upper most portion of the fourth segment 120d comprises a fourth enclosing cross-sectional area 126d, and the upper most portion of the fifth segment 120e comprises a fifth enclosing cross-sectional area 126e. The second enclosing cross- sectional area 126b is larger than the first enclosing cross-sectional area 126a, the third enclosing cross-sectional area 126c is larger than the second enclosing cross-sectional area 126b, the fourth enclosing cross-sectional area 126d has the same size as the third enclosing cross-sectional area 126c, while the fifth enclosing cross-sectional area 126e is smaller than the fourth enclosing cross- sectional area 126d. As such, the first, second, fourth and fifth segments 120a, 120b, 120d,120e all have the shape of a conical frustum, whereas the third segment 120c has a cylindrical shape.
In the embodiment of fig. 5D, the second segment 120b comprises a first opening 110a for accommodating a first branching blood vessel 1’ connected to the aorta 20, and the fourth segment 120d comprises a second opening 110b for accommodating a second branching blood vessel 1” connected to the aorta 20. The two openings 110a, 110b are radially displaced at an angle in the range 10° - 180° in relation to each other, more specifically at an angle in the range 30° - 90° in relation to each other.
Fig. 5E shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5C. However, in the embodiment of fig. 5E, the first and third segments 120a, 120c are longer in the direction of the length extension LE of the aorta 20. In the embodiment shown in fig. 5E, the first segment 120a has a length LI in the direction of the length extension LE of the aorta 20, the second segment 120b has a length L2 in the direction of the length extension LE of the aorta 20, and the third segment 120c has a length L3 in the direction of the length extension LE of the aorta 20. The first and third lengths L1,L3 are both more than two times the length of the second length L2. In alternative embodiments however, it is equally conceivable that the first and third lengths are both more than 1,2 times the length of the second length, or that the first and third length are different, such that the first length is longer than the second and third length, or that the first length is shorter than the second and third length, or that the first length is longer than the second length but shorter than the third length. Having segments of different lengths enables the segments to be adapted to the curvature and dimensions of the blood vessel which the enclose, the aneurysm on the blood vessel, and/or branching blood vessels connected to the blood vessel having the aneurysm.
The inner surface 121a of the first segment 120a has a first curvature cl in the direction of the length extension LE of the aorta, adapted to correspond to an upper portion of an aneurysm 50, for enabling the vessel member 100 to follow the contour of the aneurysm 50. The inner surface 121b of the second segment 120b has a second curvature c2 in the direction of the length extension LE of the aorta, adapted to correspond to a middle portion of an aneurysm 50, for enabling the vessel member 100 to follow the contour of the aneurysm 50, and the inner surface 121c of the third segment 120c has a third curvature c3 in the direction of the length extension LE of the aorta, adapted to correspond to a lower portion of the aneurysm 50, for enabling the vessel member 100 to follow the contour of the aneurysm 50.
In the embodiment of fig. 5E, the first curvature cl has a first radius rl, the second curvature c2 has a second radius r2. The second radius r2 is larger than the first radius rl, in particular, the second r2 is at least 2 times the first radius rl. The first radius rl is in the range 10mm - 80mm, more specifically in the range 10mm - 60mm, and even more specifically in the range 20mm - 60mm. The second radius r2 is in the range 30mm - 200mm, more specifically in the range 40mm - 150mm, and even more specifically in the range 50mm - 100mm. In the embodiment of fig. 5E, the third curvature c3 has a third radius r3 being the same as the first radius rl.
The most upper portion of the first segment 120a of the vessel member 100 comprises a first enclosing cross-sectional area 126a, and the lower most portion of the vessel member 100 comprises a second enclosing cross-sectional area 126b, and the second enclosing cross-sectional area 126b is larger than the first enclosing cross-sectional area 126a such that the first segment 120a can accommodate the upper portion of a bulging aneurysm 50 on the aorta 20.
Fig. 5F shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 5D, with the difference that the embodiment of fig. 5F comprises a first, second and third annular openings 110a, 11 Ob, 110c configured to accommodate blood vessels 1 branching from the aorta 20. The vessel member 100 of fig. 5F is made up of five segments 120a - 120e, each of which being possible to partially open such that each of the segments 120a - 120e can be placed around and encircle a portion of a blood vessel. Just as with the first segment of the embodiment of fig. 4C, each of the segments 120a - 120e comprises a pivotable joint 130 enabling the partial opening of each of the segments 120a - 120e. Each of the annular openings 110a, 110b, 110c are positioned at the joints and as such, the connecting surfaces 128’ are placed on two sides of the respective openings 110a, 110b, 110c. This means that the connecting surfaces 128’ connects around the branching blood vessels enabling the openings 110a, 110b, 110c to completely encircle the branching blood vessels. The segments 120a - 120e can be radially rotated in relation to each other, to adapt the rotational orientation of the openings 110a - 110c to the branching vessels, and as such the annular openings can be radially displaced in relation to each other, or aligned, all depending on the specific anatomy of the blood vessel at which the vessel member 100 is placed. Just as in previous embodiments, the segments are connected to each other by means of connection interfaces 124a - 124d in the form or downwards protruding protrusions configured to mate with connection interfaces in the form of upwards facing recesses 125b - 125e. The recesses and protrusions of the embodiment of fig. 5F are in the form of bayonet-type joint, in which the recesses are axially insertable into the recesses, after which they are rotated in the recess to a position in which the protrusion cannot be separated from the recess by pulling the protrusion in an axial direction.
Fig. 6A shows an embodiment of a vessel member 100 in which the vessel member 100 comprises an opening 110 in the form of a slit extending in the direction of the length extension LE of the blood vessel BV. The slit 110 is adapted for accommodating the at least one branching blood vessel 1 connected to the blood vessel BV.
In the embodiment of fig. 6A, the vessel member comprises a first enclosing cross- sectional area 126a perpendicular to the direction of the length extension LE of the blood vessel BV, placed at the upper most portion of the vessel member 100. The first enclosing cross-sectional area 126a is configured for completely enclosing a portion of the blood vessel BV. A second, central portion of the vessel member 100 comprises a second enclosing cross-sectional area 126b perpendicular to the direction of the length extension LE of the blood vessel BV. The second enclosing cross-sectional area 126b is placed at the portion of the vessel member 100 comprising the slit 110, and as such only partially encloses a portion of the blood vessel BV, as the second enclosing cross-sectional area 126b is positioned in the region of the vessel member 100 comprising an opening 110 in the form of a slit, being elongated and extending in a direction perpendicular to the length extension LE of the blood vessel BV. The slit extends over more than half of the length of the vessel member, more specifically over more than 2/3 of the length of the vessel member 100. The slit is more than two times as long as it is wide, more specifically more than three times as long as it is wide, and even more specifically more than four times as long as it is wide. The slit is adapted to accommodate at least one branching blood vessel and is suitable for accommodating more than one branching blood vessel, provided that the first and second (and further) branching bloods vessels are positioned substantially radially aligned, parallel to the length extension LE of the blood vessel BV. As an example, the Brachiocephalic artery, the left common Carotid artery 28 and the left Subclavian artery are positioned substantially radially aligned, as well as the Intercostal arteries.
The second enclosing cross-sectional area 126b has a larger area than the first enclosing cross-sectional area 126a, such that the vessel member 100 is adapted for a bulging aneurysm on the blood vessel BV.
For accommodating a bulging aneurysm on a blood vessel, any of the vessel members shown herein may have a first enclosing cross-sectional area having an area which is less than 0,9 times as large as an area of a second enclosing cross-sectional area. Preferably, any of the vessel members shown herein may have a first enclosing cross-sectional area having an area which is less than 0,8 times as large as an area of a second enclosing cross-sectional area, and even more preferably, any of the vessel members shown herein may have a first enclosing cross-sectional area having an area which is less than 0,6 times as large as an area of a second enclosing cross-sectional area.
Not to engage and risk damaging the branching blood vessel 1, there is a distance d2 between the inner edges of the slit 110 and the branching blood vessel 1 in the range 3mm - 10mm.
Fig. 6B shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 6A, with the difference that the embodiment of fig. 6B, the slit 110 is adapted to accommodate two branching blood vessels 1’, 1” which are both radially and axially displaced in relation to each other. The slit 110 is elongated and extends in a direction at an angle a in relation to the direction of the length extension LE of the blood vessel BV in the range 10° - 45°. The two branching blood vessels l’,l” are radially displaced at an angle in the range 10° - 50° in relation to each other, more specifically at an angle in the range 10° - 30° in relation to each other.
Not to engage and risk damaging the branching blood vessels l’,l”, there is a distance d2 between the inner edges of the slit 110 and the branching blood vessels l’,l” in the range 3mm - 10mm.
Fig. 6C shows an embodiment of the vessel member 100 similar to that of the embodiment of fig. 6A, with the difference that in the embodiment of fig. 6C, the vessel member 100 comprises a first and second segments 120a, 120b configured to be connected to each other in the direction of the length extension LE of the blood vessel BV, for creating the connected vessel member 100 configured to follow a shape of the aneurysm on the blood vessel BV. Just as in several of the other embodiment described herein, the first segment 120a comprises a first connection interface positioned along an axial, downwards facing area, facing a corresponding axial, upwards facing area, of the second segment 120b. The first connection interface is in the embodiment shown in fig. 6C a connection interface in the form of a connection protrusion extending downwards, whereas the connection interface of the second segment 120b is in the form of a connection recess facing upwards.
The slit 110 runs over a portion of both the first and second segments 120a, 120b, and as such, both the first and second segments comprises the slit.
Fig. 7A shows an embodiment of the vessel member in which the vessel member comprises a first part 140a, a second part 140b, a third part 140c, and a fourth part 140d. The first - fourth parts 140a - 140d are adapted to be connected to each other to form the connected vessel member 100. The parts 140a - 140d, in the embodiment shown in fig. 7A, are adapted to be assembled such that the joints between the parts 140a - 140d are substantially parallel to the direction of the length extension LE of the blood vessel to be enclosed by the vessel member 100.
In the embodiment shown in fig. 7A, each of the parts 140a - 140d comprises a connection recess 125, in the form of a groove extending in a direction parallel to the length extension LE of the blood vessel, and each of the parts comprises a connection protrusion 124, in the form of a an elastic tongue extending in a direction parallel to the length extension LE of the blood vessel and being configured to be placed in the groove for creating an interconnection between two parts for forming a portion of the vessel member 100.
In the embodiment shown in fig. 7A, the connected vessel member comprises three openings 110a, 110b, 110c each of which being configured to accommodate a branching blood vessel. In the embodiment shown in fig. 7A, the openings 110a, 110b, 110c are positioned at the joints between the parts, such that both parts comprise a portion of the opening. This enables the parts to be placed around the branches when putting the vessel member 100 into place.
Each of the parts in the embodiment of fig. 7A has an inner surface 121 facing the outer surface of the portion of the blood vessel enclosed by the vessel member 100. The inner surfaces 121 of the parts 140a - 140d of the vessel member 100 has a curvature cl with a radius rl, in the direction of the length extension LE of the blood vessel and is configured to follow the curvature of an aneurysm on the blood vessel. The inner surfaces 121 of the parts 140a - 140d together forms a circle with a radius r2, i.e. the curvature c2 of the circle having the radius r2. As such, a first curvature cl having a first radius rl is configured to follow a curvature of the blood vessel in the direction of the length extension LE of the blood vessel, and a second curvature c2 is configured to follow a curvature of the circumference of the blood vessel in a cross-sectional plane perpendicular to the length extension LE of the blood vessel. In the embodiment shown in fig. 7A, the first radius rl is larger than the second radius r2, more specifically, the first radius rl is more than 2 times the second radius r2. In the embodiment shown in fig. 5A, the first radius rl is in the interval 12mm - 45mm, more specifically in the interval 15mm - 40mm, and even more specifically in the interval 20mm - 40mm. In the embodiment shown in fig. 7A, the second radius r2 is in the interval 3mm - 25mm, more specifically in the interval 4mm - 15mm, and even more specifically in the interval 6mm - 12mm.
The upper most portion of the vessel member 100 of fig. 7A comprises a first enclosing cross-sectional area 126a, and a central portion of the vessel member 100, in the center of the openings 110a, 110b, 110c comprises a second enclosing cross-sectional area 126b. In the embodiment shown in fig. 7A, the first enclosing cross-sectional area 126a is configured to completely encircle a first portion of the blood vessel, whereas the second enclosing cross-sectional area 126b is configured to only partially encircle the blood vessel, as the second enclosing cross- sectional area 126b comprises the openings 110a, 110b, 110c, each configured to accommodate at least one branching blood vessel. The second enclosing cross-sectional area 126b has a larger area than the first enclosing cross-sectional area 126a, such that the vessel member 100 is adapted for a bulging aneurysm on the blood vessel.
Fig. 7B shows a detailed view of the connection recess 125 and connection protrusions 124 for connecting the parts 140a - 140d of the vessel member 100 of the embodiment shown in fig. 7A. The connecting protrusion 124 has a horseshoe-shaped cross-section and is elastic by means of the horseshoe-shape being compressible, such that the outer periphery of the connecting protrusion 124 goes from having a circular shape to assuming an elliptical shape, such that the connecting protrusion 124 can enter into the connecting recess 125 for connecting the parts 140a - 140d to each other.
In the embodiment shown in fig. 7B, the connection between the connecting protrusion 124 and the connecting recess 125 is locked by means of a locking member 132 insertable inside of the horseshoe-shaped cross-section, such that the connecting protrusion 124 is locked in the connecting recess 125 without the ability of being removed from the connecting recess 125.
Fig. 7C shows a detailed view of the connecting recess 125 and connecting protrusion 124 for connecting the parts 140a - 140d of the vessel member 100 of the embodiment shown in fig. 7A, when an elastic locking member 132 is inserted into the center of the horseshoe-shaped crosssection of the connecting protrusion 124 and further follows a locking member channel 133 extending in the wall of the fourth part 140d, such that the locking member 132 bends around the opening 110 in the fourth part 140d enabling locking of the connecting protrusion 124 in the connecting recess 125 from one direction even in embodiments when the opening 110 is placed in the joint between two parts.
Fig. 8A shows an embodiment of the vessel member 100 comprises at least one branch supporting element 134’, 134” extending in a direction substantially radially in relation to the length extension LE of the blood vessel BV. The branch supporting elements 134’, 134” are configured to encircle the branching blood vessels 1 ’, 1 ” and make the transfer between the vessel member and the branching blood vessel smoother and reducing the risk that the branching blood vessels 1 ’, 1 ” are damaged as they bend relative to the surface of the blood vessel BV. In the embodiment shown in fig. 8, the branch supporting elements 134’, 134” extends a distance in the range 1mm - 10mm from the outer surface of the vessel member 100, in a substantially radial direction in relation to the length extension LE of the blood vessel BV. In the embodiment shown in fig. 8, the branch supporting elements 134’, 134” are materially integrated with the vessel member 100, i.e. they are made from the same material as the vessel member. However, in alternative embodiments, the branch supporting elements 134’, 134” could be made from a different material and could be separate from the vessel member 100. The branch supporting elements 134’, 134” could have a longitudinal slit in a direction perpendicular to a length extension of the branching blood vessel 1 ’, 1 ”, such that the branch supporting elements 134’, 134” could be placed over the branching blood vessel 1 ’ , 1 ” .
Fig. 8B shows an embodiment of the vessel member 100 configured to be placed at the aorta bifurcation 2. For the purpose of accommodating the aorta 20 at the aorta bifurcation 2, the vessel member 100 is made like a three-way channel comprising a first main entry 119a aligned with the length extension LE of the aorta 20 and directed in the cranial direction. The three-way channel further comprises a second and third entry 191b, 191c aligned with a second and third length axis LE’,LE” respectively. The second and third length axis LE’,LE” following the center of the right and left common iliac arteries 31,31’, such that the second and third entry 19 lb, 191c are placed at an angle relative to the first main entry 119a, an angle which corresponds and is adapted to the angle of the right and left common iliac arteries 31,31 ’ relative to the length extension LE of the aorta 20. The vessel member of the embodiment of fig. 8B further comprises an opening 110 for accommodating a branching blood vessel 1. The embodiment of the vessel member 100 configured to be placed at the aorta bifurcation could be combined with any of the adjustable or passive embodiments of vessel members 100 disclosed herein, and the vessel member 100 could be configured to be placed on the aorta by means of the vessel member being possible to open, such as in the embodiments disclosed with reference to figs. 4C,5F,13A and 13B, or by means of the vessel member 100 comprising a plurality of parts, such as in the embodiments disclosed with reference to figs. 4B and 7A, or by means of the vessel member 100 comprising a plurality of segments, such as in the embodiments disclosed with reference to figs. 4A - 5F. The vessel member my be adjustable, such as disclosed with reference to figs. 15A - 17 and 24A - 25E.
Fig. 9A shows an embodiment of the vessel member 100 in which the vessel member 100 comprises a recess 150 in the form of a furrow 150 adapted to accommodate a branching blood vessel 1. The furrow 150 extends substantially in the direction of the length extension LE of the blood vessel BV and is in the embodiment shown in fig. 9A made by the vessel member 100 being shaped with a protruding portion 151 on the outer surface, which houses the recess 150 extending in the inner surface of the vessel member 100, such that the recess 150 accommodates the branching blood vessel 1 between the vessel member 100 and the blood vessel BV. In the embodiment shown in fig. 9A, the branching blood vessel 1 is a branching blood vessel protruding in an upwards direction in relation to toe blood vessel BV form which it branches. The branching blood vessel is therefore further bent in the upwards direction such that the length extension of the branching blood vessel 1 becomes substantially parallel to the length extension LE of the blood vessel BV from which it branches. In the embodiment shown in fig. 9A, the branching blood vessel 1 branches from the blood vessel BV in a region of the aneurysm. However, in alternative embodiments, the branching blood vessel may branch from the blood vessel close to or in the vicinity of the aneurysm and thereby having to be placed in an accommodating recess.
Fig. 9B shows an embodiment of the vessel member 100 similar to that shown in fig. 9A, with the difference that in the embodiment shown in fig. 9B the furrow 150 adapted to accommodate the at least one branching blood vessel 1 extends in a direction at an angle a in relation to the direction of the length extension LE of the blood vessel BV, the angle a is an angle in the range 10° - 45°, more specifically, in the embodiment of fig. 9B of about 30°. The angled recess/furrow 150 of fig. 9B is thus adapted to accommodate a branching blood vessel 1 branching substantially at the angle a in relation to the length extension LE of the blood vessel BV.
Fig. 9C shows an embodiment of the vessel member 100 similar to that shown in fig. 9A, with the difference that in the embodiment shown in fig. 9C, the vessel member 100 comprises recesses 150’, 150” in the form of a first and a second furrow 150’, 150” adapted to accommodate a first and a second branching blood vessel 1 ’, 1 ” branching from two radially displaced locations on the blood vessel BV. As such, the first and second furrows 150’, 150” are radially displaced at an angle P in relation to each other, relative to the length extension LE of the blood vessel BV. I.e., a first radius extending from the center of the first branching blood vessel 1 ’ to the length extension LE of the blood vessel BV, and a second radius extending from the center of the first branching blood vessel 1 ’ to the length extension LE of the blood vessel BV, and the angle being the angle between the two radii in a plane perpendicular to the length extension LE of the blood vessel BV. In the embodiment shown in fig. 9C, the recesses 150’, 150” extends along the entire length of the vessel member 100, parallel to the length extension LE of the blood vessel BV. In alternative embodiment it is however equally conceivable that one or both of the recesses extends only along a portion of the length of the vessel member 100. In the embodiment shown in fig. 9C, the branching blood vessels 1 ’, 1 ” connects to the blood vessel BV in the same plane perpendicular to the length axis of the blood vessel BV. I.e. at the same vertical height in relation to the illustration of fig. 9C. In alternative embodiment it is however equally conceivable that the branching blood vessels connect to the blood vessel BV at different heights and that the recesses are correspondingly adapted.
Fig. 9D shows an embodiment of the vessel member 100 similar to that shown in fig. 9A, with the difference that in the embodiment shown in fig. 9D a combination of a recess 150 and an opening 110 is shown. The recess 150 in the form of a furrow 150 is connected to the opening 110, such that a branching blood vessel 1 can extend in the recess 150 and further through the opening 110. The combination of recesses and openings enables the adaptation of the vessel member 100 to the anatomy of the blood vessel BV and the branching vessels, as well as a slight alteration of the path that such branching blood vessels. In the embodiment shown in fig. 9D, the opening is an annular opening in the form of a through-hole, however in alternative embodiments the opening may be an opening according to any one of the embodiments of openings described herein. The vessel member could in alternative embodiments comprise more than one recess and/or more than one opening.
Fig. 9E shows an embodiment of the vessel member 100 similar to that shown in fig. 9A, with the difference that in the embodiment shown in fig. 9E, the vessel member 100 comprises a first and second segment 120a, 120b (the features of which being similar to the embodiment disclosed with reference to fig. 4A). In the embodiment shown in fig. 9E, the first and second segments 120a, 120b each comprises a portion of the recess 150 for accommodating the branching blood vessel 1, such that the joint between the first and second segments 120a, 120b passes the recess 150.
Fig. 9F shows an embodiment of the vessel member 100 similar to a combination of the embodiments shown in figs. 9C and 9E. In the embodiment shown in fig. 9F, the vessel member 100 comprises a first and second segment 120a, 120b each comprising a recess 150’, 150” for accommodating a first and a second the branching blood vessel 1 ’, 1 ” . The first and second recesses 150’, 150” are not connected to each other, rather, on the contrary, the first and second recesses 150’, 150” are radially displaced at an angle P in relation to each other, relative to the length extension LE of the blood vessel BV. I.e., a first radius extending from the center of the first recess 150’ to the length extension LE of the blood vessel BV, and a second radius extending from the center of the second recess 150” to the length extension LE of the blood vessel BV, and the angle being the angle between the two radii in a plane perpendicular to the length extension LE of the blood vessel BV. I.e. in fig. 9F, the plane in which the joint between the first and second segments 120a, 120b extend. As such, the two recesses 150’, 150” are adapted to accommodate a first and a second branching blood vessel 1 ’, 1 ” branching from two radially displaced locations on the blood vessel BV, and the first branching blood vessel 1 ’ extends in an upwards direction in relation to the orientation of fig. 9F, whereas the second branching blood vessel 1” extends in an opposite - downward direction. In the embodiment shown in fig. 9F, the recesses 150’, 150” extend along the entire length of the respective segments 120a, 120b, i.e. each recess 150’, 150” extends along half of the entire length of the connected vessel member 100, parallel to the length extension LE of the blood vessel BV.
In alternative embodiment it is however equally conceivable that one or both of the recesses 150’, 150’ ’extend only along a portion of the length of the respective segments 120a, 120b. In the embodiment shown in fig. 9F, the branching blood vessels 1 1 ” connects to the blood vessel BV in the same plane perpendicular to the length axis of the blood vessel BV. I.e. at the same vertical height in relation to the illustration of fig. 9F. In alternative embodiment it is however equally conceivable that the branching blood vessels connect to the blood vessel BV at different heights and that the recesses are correspondingly adapted.
Fig. 9G shows an embodiment of the vessel member 100, in which a first segment 120a comprises a first recess 150’ leading to a first opening 110a for accommodating a first branching blood vessel 1’. The vessel member 100 further comprises a second segment 120b comprising a second recess 150” for accommodating a second branching blood vessel 1”. The first opening 110a and the first recess 150’, and the second recess 150” are radially displaced at an angle P in relation to each other, relative to a length extension LE center axis of the blood vessel BV. The angle is in the embodiment shown in fig. 9G an angle in the range 10° - 180°, but could in other embodiments be in the range 20° - 100°.
Fig. 10A shows a schematic illustration of an embodiment of a vessel member 100 illustrating the principle of having a first portion of the vessel member 100 being angled in relation to a second portion of the vessel member. The illustration of this principle is applicable or possible to combine at least with the embodiment described with reference to figs. 4A,4B,4C,5A,5B,5C,5D,5E,5F,6A,6B,6C,7A,9A,9B,9C,9D,9E and 9F. In the embodiment shown in fig. 10A, the two angled portions are parts of two different segments, a first and a second segment 120a, 120b, being configured to be connected for forming a connected vessel member 100. However, it is equally conceivable that the two portions are just two portions of the same, materially integrated, vessel member, I.e. a single segment having a first and a second portion being angled in relation to each other. In the embodiment shown in fig. 10 A, the first inner surface 121a is a surface of the first portion, which in the embodiment of fig. 10A is the same as the first segment 120a. The first inner surface 121a is angled with an angle a in relation to the second inner surface 121b, which is a surface of the second portion, which in the embodiment of fig. 10A is the same as the second segment 120b. In the embodiment shown in fig. 10A, the first segment 120a has the shape of a conical frustum, while the second segment 120b is a cylindrical segment - and as such the inner surface 121b of the second segment 120b is cylindrical. As such, there is a second axis A2, in the form of a second straight line on the second inner surface 121b of the second segment 120b, extending on an axial plane AP intersecting the length extension LE of the blood vessel BV, which is parallel to the length extension LE of the blood vessel BV. Further, a first axis Al in the form of a first straight line on the first inner surface 121a of the first segment 120a extends on the axial plane AP intersecting the length extension LE of the blood vessel BV. The first and second axis A1,A2 are connected and there is an angle a between the first and second axis A1,A2. In the embodiment shown in fig. 10A, the first angle a is in the range 3° - 90°, more specifically in the range 5° - 45°, more specifically in the range 10° - 30°. In the embodiment of fig. 10A, the second segment 120b has a length in the direction of the length extension LE of the blood vessel BV exceeding 4mm. I.e., a second straight line extending on the inner surface 121b of the second segment 120b and following the second axis A2 has a length exceeding 4mm. In the embodiment of fig. 10A, the first segment 120a has a length in the direction of the length extension LE of the blood vessel BV exceeding 4mm. I.e., a first straight line extending on the inner surface 121a of the first segment 120a and following the first axis Al has a length exceeding 4mm.
Fig. 10B shows a schematic illustration of an embodiment of a vessel member 100, similar to the embodiment described with reference to fig. 10A, i.e. the embodiment of fig. 10B also illustrating the principle of having a first portion of the vessel member 100 being angled in relation to a second portion of the vessel member 100. The illustration of this principle is also applicable or possible to combine at least with the embodiment described with reference to figs. 4A,4B,4C,5A,5B,5C,5D,5E,5F,6A,6B,6C,7A,9A,9B,9C,9D,9E and 9F. Just as the embodiment of fig. 10A, the embodiment of fig 10B shows two angled portions being parts of two different segments, a first and a second segment 120a, 120b, being configured to be connected for forming a connected vessel member 100. However, it is just as in the embodiment of fig. 10A equally conceivable that the two portions are just two portions of the same, materially integrated, vessel member. I.e. a single segment having a first and a second portion being angled in relation to each other. In the embodiment shown in fig. 10B, the second segment 120b is a cylindrical segment, while the first segment is a segment having a varying angle in relation to the second segment. As such, there is a second axis A2, in the form of a second straight line on the second inner surface 121b of the second segment 120b, extending on an axial plane AP intersecting the length extension LE of the blood vessel BV, which is parallel to the length extension LE of the blood vessel BV. Further, a first axis Al in the form of a first straight line on the first inner surface 121a of the first segment 120a extends on the axial plane AP intersecting the length extension LE of the blood vessel BV. The first and second axis A1,A2 are connected and there is an angle P between the first and second axis A1,A2. In difference to the embodiment shown in fig. 10A, there is, in the embodiment shown in fig. 10B, also a fourth axis A4, in the form of a fourth straight line on the second inner surface 121b of the second segment 120b, extending on an axial plane AP intersecting the length extension LE of the blood vessel BV, which is parallel to the length extension LE of the blood vessel BV, and a third axis A3 in the form of a third straight line on the first inner surface 121a of the first segment 120a extending on the axial plane AP intersecting the length extension LE of the blood vessel BV. The third and fourth axis A3,A4 are connected and there is an angle a between the third and fourth axis A3,A4. The angle a is different from the angle .
In the embodiment shown in fig. 10B, the first straight line and the third straight line, i.e. following the first and third axis Al, A3 are configured to extend on opposite sides of the blood vessel BV, i.e. the first and third axis Al, A3 are radially displaced in relation to the length extension LE of the blood vessel BV with 180°.
In the embodiment shown in fig. 10B, the angle P is smaller than the angle a. Specifically, in the embodiment shown in fig. 10B, the angle is more than 3° smaller than the angle a, and more specifically more than 5° smaller than the angle a.
In the embodiment shown in fig. 10B, the angular difference between the angle P and the angle a is more than 3°, more specifically more than 5°, , and even more specifically more than 10°.
Fig. 11 shows a schematic illustration of an embodiment of a vessel member 100, similar to the embodiment described with reference to fig.lOA, i.e. the embodiment of fig. 11 also illustrating the principle of having portions of the vessel member 100 being angled in relation to each other. In the embodiment shown in fig. 11, the vessel member comprises a first, second third and fourth portion, being part of a first, second, third and fourth segment 120a, 120b, 120c, 120d. In alternative embodiments it is however equally conceivable that the portions are portions of the same, materially integrated, vessel member 100. The first and fourth segments 120a, 120d are cylindrical - and as such the inner surfaces 12 la, 12 Id of the first and fourth segments 120a, 120d are cylindrical. The second and third segments 120b, 120c both have the shape of a conical frustum. Each of the first, second, third and fourth portions here being portions of the first, second, third and fourth segments 120a, 120b, 120c, 120d have inner surfaces 121a, 121b, 121c, 12 Id facing the outer surface of the blood vessel BV. The inner surface 121a of the first portion/segment 120a of the vessel member is angled relative to the second portion/segment 120b, and the second portion/segment 120b is angled relative to the third portion/segment 120c, and the third portion/segment 120c is angled relative to the fourth portion/segment 120d. As such, the vessel member 100 can follow a curvature of the blood vessel BV in the direction of the length extension LE of the blood vessel BV. The inner surface 121a of the first portion/segment 120a of the vessel member is angled with an angle a relative to the second portion/segment 120b, and the third portion/segment 120c is angled with an angle a relative to the fourth portion/segment 120d, as such, the second portion/segment 120b is angled with an angle P relative to the third portion/segment 120c that equals 180°-2*a.
In the embodiment shown in fig. 11, the angles a are in the range 10° - 45°, and more specifically in the range 10° - 30°.
Fig. 12 shows a schematic illustration of an embodiment of a vessel member 100, similar to the embodiment described with reference to fig.l 1. The difference being that in the embodiment shown in fig. 12, the vessel member 100 comprises a first and second portion/segment 120a, 120b, each having an inner surface 12 la, 12 lb. The inner surface 121a of the first portion/segment 120a has a first curvature Cl with a radius Rl, and the inner surface 121b of the second portion/segment 120b has a second curvature C2 with a radius R2. The first and second curvatures C1,C2 enables the vessel member 100 to follow the curvature of the blood vessel BV. In the embodiment shown in fig. 12, the first and second curvatures C1,C2 have equal radii R1,R2, however, in alternative embodiments it is equally conceivable that the first radius R1 is larger than the second radius R2, or that the first radius R1 is smaller than the second radius R2. In the embodiment shown in fig. 12, the first and second radii R1,R2 are in the range 12mm - 45mm, more specifically in the range 15mm - 40mm, and even more specifically in the range 20mm - 40mm. In the embodiment shown in fig. 12, the vessel member is made up of a first and second segment. However, in alternative embodiments it is equally conceivable that the vessel member is a single, materially integrated, vessel member 100, which may comprise different curvatures along its inner surface to follow the curvature of the blood vessel BV.
Fig. 13A - 13C shows the vessel member according to the embodiment further described with reference to fig. 5D, when the third segment 120c of the vessel member is fixated to an attachment device 182 for attaching the vessel member to a portion of the body of the patient, more specifically in the embodiments of figs. 13A - 13C to a portion of the body of the patient comprising bone, and even more specifically in the embodiment of figs. 13A - 13C, to the spine of the patient. The attachment device 182 comprises an elongated distance element 185, connecting the third segment 120c of the vessel member to a curved fixation plate 183 comprising through- holes for receiving orthopedic screws 186 for fixating the curved fixation plate 183 to the cortical bone of at least one vertebra of the spine 80 of the patient. In the embodiment of the attachment device 182 shown in fig. 13B, the elongated distance element 185 comprises a flexible portion 184 placed between the vessel member and the fixation plate 183 for enabling movement between the vessel member and the fixation position at the spine of the patient. This may be necessary to not introduce stress in the blood vessel BV as the patient moves and the blood vessel moves relative to the spine of the patient. The flexible portion 184 may comprise an elastic structure, such as a spring, and/or elastic material, such as a biocompatible elastomeric polymer material.
Fig. 13C shows the vessel member when the third segment 120c of the vessel member 100 has been attached to the spine 80 of the patient by means of orthopedic screws 186 placed in through-holes in the fixation plate 183. In the embodiments shown in figs. 13A - 13C, the entire vessel member 100 is fixated by means of a single attachment device fixated to one segment of the vessel member. I.e. the other segments of the vessel member are attached to the spine 80 indirectly by means their direct or indirect connection to the segments fixated to the attachment device 182. In alternative embodiments however, the implantable system may comprise a plurality of attachment devices, such that several of the segments may be directly connected to an attachment device. This is for example disclosed in the embodiments shown in figs. 14 and 18C. In the embodiment shown in figs. 13A - 13C, the plate 183 has a curved shape adapted to fit the spine 80 of the patient. However, in embodiments where the attachment device 182 is attached to other portions of the body, the plate 183 could have any shape. Fig. 14 shows the vessel member 100 according to the embodiment further described with reference to fig. 5D, when the implantable system further comprises four attachment devices 182 ’,182 ”,182 ”’,182”” for attaching the vessel member 100 to a portion of the body of the patient, more specifically in the embodiment of fig. 14 to a portion of the body of the patient comprising soft tissue. The four attachment devices each comprising an elongated distance element 185’ - 185”” and a patch 187 fixated to the elongated distance elements 185. The patch 187 being configured to be fixated to soft tissue of the patient for example by means of suturing, stapling, growth-in of fibrotic tissue or a combination thereof. The first and second elongated distance elements 185’, 185” are fixated to the first segment 120a of the vessel member 100, while the third and fourth elongated distance element 185’”, 185”” are fixated to the fifth segment 120e of the vessel member 100. The elongated distance elements 185’ - 185”” are preferably made from an elastic material, such as a biocompatible elastomeric polymer material. The second, third and fourth segments 120b, 120c, 120d are fixated to the attachment devices 182’ - 182 ‘ ’ ” indirectly, by means of their direct or indirect fixation to the first and fifth segments 120a, 120e.
The soft tissue could in different embodiments be muscle tissue, such as the right or left crus, the psoas minor, the psoas major, the quadratus lumborum, the transverse abdominal, the obliques, the iliacus or the diaphragm. In the alternative, one or more of the attachment devices 182’ - 182 ‘ ’ ” may be configured to be attached to a portion of the body of the patient comprising fascia, which may be superficial fascia, deep fascia, the transversalis fascia, the parietal peritoneum, the greater omentum, the lesser omentum or the linea alba.
Fig. 15A shows an embodiment of the medical device in which all of the five segments 120a - 120e are individually hydraulically adjustable. Each of the five segments comprises an inflatable portion in form of a hydraulic cuff 601a - 60 le positioned on the inner surfaces of the segments 120a - 120e. The connection of the segments of the vessel member 100 of fig. 15A as well as the openings are the same as is further described with reference to fig. 5D.
The adjustable vessel member 100 encloses an enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel and a hydraulic operation device of the implantable system is adapted to adjust the pressure exerted by the adjustable vessel member on the blood vessel by altering the size of the enclosing cross-section area.
In the embodiment shown in fig. 15 A, the hydraulic cuffs 601a - 60 le of the five segments are each connected to a control valve 660 enclosed in a housing. The control valve 660 receives force in the form of pressurized hydraulic fluid from a connection 650 comprising a fluid conduit fluidly connecting the control valve 660 to a remote unit (such as further described with reference to figs. 3 and 17), which in turn comprises a hydraulic pump (for example any of the hydraulic pumps 604 described with reference to figs. 46A - 50) pressurizing the hydraulic fluid. The control valve controls and distributes hydraulic fluid via conduits 65 la - 65 le to the hydraulic cuffs 601a - 60 le, such that each of the hydraulic cuffs 601a - 60 le can be individually adjusted for altering the distance between the hydraulic cuff 601a - 60 le and the blood vessel and/or the pressure exerted on different portions of the blood vessel. The hydraulic pump and the control valve form part of the operation device for operating the adjustable vessel member. By having an individually adjustable system, the correct distance and/or pressure for a particular aneurysm and/or particular portion of the aneurysm can be applied. The system of individually adjustable cuffs 601a - 60 le as shown in fig. 15A may be implemented in any of the embodiments of vessel members shown herein, and especially in the vessel members described with reference to figs. 4A - 14.
In all of the embodiments described above, the vessel member may be configured to be placed at a distance from the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel. As such, the vessel member does not risk damaging the blood vessel in situations in which connection between the vessel member and the blood vessel is not needed. In hydraulic embodiments, the distance between the vessel member and the blood vessel could be the distance between the blood vessel and a hydraulic cuff positioned on the inner surface of the vessel member, and this distance may be adjusted by adjusting the amount of hydraulic fluid in the hydraulic cuff 601a - 601e.
The adjustable vessel member 100 of fig. 15A is in non-critical situations configured to be placed at a distance in the interval 0,5mm - 3mm from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel. However, if the aneurysm expands such that the situation goes from being non-critical to being critical, the adjustable vessel member is configured to engage the outer surface of the blood vessel for exerting a counter force or a pressure on the blood vessel to hinder or reverse the expansion of an aneurysm. The adjustable vessel member in the embodiment shown in fig. 15A is adapted to exert a pressure in the range between the systolic and the diastolic blood pressure of the patient, such that a counter force is created without hampering the blood flow in the tissue wall of the blood vessel. The systolic blood pressure in a healthy patient should be below 120 mm Hg, and the diastolic blood pressure should be below 80 mm Hg. This means that the vessel member should be adapted to exert a pressure on the blood vessel in the range 80 mm Hg - 120 mm Hg, preferably in the range 90 mm Hg - 110 mm Hg.
Fig. 15B is a cross sectional view of the fifth segment 120e in which it is shown in further detail how the conduit 15 le enters through the supporting structure 602 of the fifth segment and into the hydraulic cuff 601 such that a fluid connection between the conduit 15 le and the hydraulic cuff 601 is created. The hydraulic cuff 601 in the embodiment shown in fig. 15B is made from a biocompatible elastomeric polymer material, such as a silicone or polyurethane based polymer material. The conduit is integrated in the hydraulic cuff and as such made from essentially the same biocompatible elastomeric polymer material such that a material integration is created which reduces the risk of leakage.
As is further described with reference to figs. 3, 17 and 24 - 57N, the operation device operating the adjustable vessel member is controlled by an implantable controller. The implantable controller may be configured to receive sensor input and control the operation device on the basis of the sensor input. 80. The implantable system according to any one of claims 70 - 79, further comprising at least one sensor connected to the implantable controller. The sensor could be a sensor configured to sense a physical parameter of the implantable system, such as a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient. The sensor configured to sense a parameter related to strain in the implantable system could be configured to sense a strain in the adjustable vessel member connected to the expansion of the aneurysm. In the hydraulic embodiment of fig. 15 A, the sensor could be a sensor measuring the strain in the implantable system by measuring the volume or pressure in a hydraulic cuff (601a - 60 le), or in a conduit or fluid reservoir connected to the hydraulic cuff. In the alternative, the sensor could be a sensor configured to measure strain in the implantable system by measuring elongation of an element in connection with the blood vessel.
The sensor may be comprised in the inner surface of the adjustable vessel member, such as in the portion of the hydraulic cuff in connection with the blood vessel.
The implantable system comprising a vessel member according to any one of the embodiments herein could also comprise a sensor configured to sense at least one physiological parameter of the patient. The physiological parameter of the patient could be related to the blood pressure of the patient, the size of the aneurysm, the expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker. The physiological parameter may also comprise a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel. The implantable controller could be configured to transmit information based on sensor input to a source external to the body of the patient.
In alternative embodiments, the implantable system may further comprise a conduit for creating a fluid connection between the first and second inflatable portion, such as for example further described with reference to figs. 19C.
Fig. 16a shows a schematic illustration of an embodiment of a vessel member 100 illustrating the principle of having a first part 140a and a second part 140b adapted to be connected to each other to form a connected vessel member 100. The vessel member is shown in an axial view, along the length extension of the blood vessel on which the vessel member is to be placed.
The illustration of this principle is applicable or possible to combine at least with the embodiment described with reference to figs.
4A,4B,4C,5A,5B,5C,5D,5E,5F,6A,6B,6C,7A,9A,9B,9C,9D,9E,9F,9G,10A,I0B,I I,I2,I3A,I3B,I3 C,14,I5A and 15B. In the embodiment shown in fig. 16a, the vessel member is an adjustable vessel member, and more particularly, a hydraulically adjustable vessel member. The first part 140a comprises a first adjustable hydraulic element 601a and the second part 140b comprises a second hydraulic element 601b. The first and second hydraulic element 601a, 601b are together configured to form a hydraulic cuff enclosing the blood vessel onto which the vessel member is to be placed. The first and second hydraulic elements 60 la, 60 lb are fixated to a support structure 602 of the first and second parts 140a, 140b, e.g. by means of an adhesive.
In the embodiment shown in figs. 16a - 16c the parts of the vessel member 140a - 140d forms a kit, such that the connected vessel member 100 can be formed by connecting two parts from the kit of parts. The connected vessel member 100 has a periphery P surrounding the blood vessel when implanted. In the embodiment shown in figs. 16a - 16c, the kit comprises a first, second, third and fourth parts 140a, 140b, 140c, 140d. The second, third and fourth parts 140b, 140c, 140d are all configured to be connected to the first part 140a for forming the connected vessel member 100. By having a kit of exchangeable parts, the connected vessel member 100 can be made to match the particular blood vessel having the aneurysm of the particular patient. In the embodiment shown in fig. 16a, the second part 140b has a curvature Cb having the same radius R1 as a curvature Ca of the first part 140a. The third part 140c has a more U-shaped cross section perpendicular to the axial direction of the blood vessel and is adapted for a larger blood vessel, or a blood vessel having a more oblong cross-section. The third part 140c has a curvature Cc having a smaller radius R3. The fourth part 140d is adapted for a smaller blood vessel and has a shallower cross-section perpendicular to the axial direction of the blood vessel and thus has a curvature Cd having a larger radius R2 than the radii R1 and R3.
The first part 140a comprises a first operable hydraulic element 601a configured to be inflated with a hydraulic fluid entering the first operable hydraulic element 601a through a first hydraulic fluid conduit 65 la via a tubing fixation portion 655a. The second, third and fourth parts 140b, 140c, 140d all comprise a second operable hydraulic element 601b configured to be inflated with a hydraulic fluid entering the second operable hydraulic element 601b through a second hydraulic fluid conduit 651b via a tubing fixation portion 655b.
The first, second, third and fourth parts 140a, 140b, 140c, 140d all comprises connecting portions 140a’, 140b’, 140c’, 140d’, 140a”, 140b”, 140c”, 140d” for connecting the first part 140a to the second, third and fourth parts 140b, 140c, 140d respectively. The connections could be hinged connections or fixed connections and enables the connected vessel member to be placed around a blood vessel to be treated/monitored.
The first and second operable hydraulic elements 60 la, 60 lb may be connected to the same hydraulic system (hydraulic pump and/or valve) or may be connected to separate hydraulic systems. In the embodiment shown in figs. 16A - 16C the parts 140a - 140d are adapted to be assembled such that the joints between the parts 140a - 140d are substantially parallel to the direction of the length extension of the blood vessel to be enclosed by the connected vessel member 100.
In the embodiment shown in fig. 16A, the operable hydraulic elements faces the outer surface of the portion of the blood vessel enclosed by the connected vessel member 100. The inner surfaces of the parts 140a, 140b together forms a circle with a radius Rl, i.e. the curvatures Ca,Cb of the circle has the radius Rl. As such, the curvatures Ca,Cb are configured to follow a curvature of the circumference of the blood vessel in a cross-sectional plane perpendicular to the length extension of the blood vessel.
In the embodiment shown in fig. 16A, the radius Rl is in the interval 3mm - 25mm, more specifically in the interval 4mm - 15mm, and even more specifically in the interval 6mm - 12mm.
In the embodiment shown in fig. 16B, third part 140c has an identical curvature and connecting portions 140c’, 140c” as the third part shown in fig. 16A. The difference is that the third part 140c of the embodiment shown in fig. 16B does not comprise an operable hydraulic element, instead the third part 140c comprises a cushioning element 630 configured to either contact or be placed at a distance from the blood vessel. The cushioning element 630 is fixated to the inner surface of the third part 140c by means of an adhesive and is more resilient than the supporting structure 602 of the third part 140c.
The cushioning element 630 could be made from a medical grade silicone material and could be filled with a biocompatible gel which enables the cushioning element 630 to be shaped to suit the blood vessel which reduces the risk that the contact with the blood vessel damages the blood vessel. In alternative embodiments, it is conceivable that the cushioning element 630 comprises a solid resilient material, such as a soft medical grade silicone of polyurethane material.
Fig. 16C shows an alternative embodiment of the fourth part 140d. The fourth part 140d has an identical curvature and connecting portions 140d’,140d”, the difference is that the supporting element 140d of the embodiment shown in fig. 16C does not comprise an operable hydraulic element, instead the supporting element 140d comprises a cushioning element 630 just as in the embodiment shown in fig. 16B.
Fig. 17 shows the abdominal cavity of a human patient when an implantable system for handling an aneurysm in a blood vessel of a patient has been implanted. In the embodiment of fig. 17, the system comprises a vessel member 100 being an adjustable vessel member 100 positioned on the aorta at the aortic arch 30 of the patient, in the thoracic portion of the aorta, such that the vessel member 100 partially encloses the aorta in a region of an aneurysman on the artic arch 30. The aorta at the aortic arch 30 is a blood vessel having a substantially tube-shaped tissue having a length and an annular circumference in a cross-section perpendicular to the direction of the blood flow and perpendicular to the length extension of the aorta. The implantable system of fig. 17 further comprises an implantable operation device placed in a remote unit 600 connected to the adjustable vessel member 100 for post-operatively adjusting the adjustable vessel member 100.
The aortic arch 30 has a curvature in the direction of the length extension of the aorta, and the adjustable vessel member comprises an inner surface configured to face an outer surface of the aorta and is adapted to accommodate the curvature in the direction of the length extension of the aorta either by the inner surface of the adjustable vessel member 100 comprising at least one curvature configured to be placed in the direction of the length extension of the aorta, or by the inner surface of the adjustable vessel member 100 comprising at least a first and a second portion which are angled or displaced relative to each other.
The vessel member 100 illustrated in fig. 17 is clearly only an example of an embodiment possible to implant, fixate and connect in the way done in fig. 17 and it is clear that any of the embodiments of the vessel member 100 disclosed herein can be implanted, fixated and connected in the manner described with reference to fig. 17. In the embodiment shown in fig. 17, the vessel member 100 is operated by a remote unit 600 which may be any of the embodiments of remote units disclosed herein. The remote unit 600 comprises a first portion 64 T, a second portion 641 ”, and a connecting portion 642, mechanically connecting the first and second portions 641 ’,641”. The second portion 641” is in the embodiment shown in fig. 17 placed on the inside of muscular tissue MT of the abdominal wall AW of the patient, whereas the first portion 641 ’ is placed on the outside of the muscular tissue MT of the abdominal wall AW, in the subcutaneous tissue ST. As such, the connecting portion 642 travels through a created hole in, or natural orifice between, the muscles of the muscular tissue MT. A cross-sectional area of the connecting portion 642, in a plane in the extension of the muscular tissue MT is smaller than a cross-sectional area of the first and second portions 641 ’,641”, parallel to the cross-sectional area of the connecting portion 642. The cross-sectional areas of the first and second portions 641 ’,641 ” are also larger than the created hole or natural orifice though which the connecting portion 642 is placed. As such, the first and second portions 641 ’,641” are unable to pass through the created hole or natural orifice and is as such fixated to the muscular tissue MT of the abdominal wall. This enables the remote unit 600 to be suspended and fixated to the muscle tissue MT of the abdominal wall AW.
In the embodiment shown in fig. 17, the connecting portion 642, is a connecting portion 642 having a circular cross-section and an axial direction AD extending from the first portion 641 ’ to the second portion 641”. The plane in the extension of the muscular tissue MT, is in the embodiment of fig. 17 perpendicular to the axial direction AD of the connecting portion 642 extending from the first portion 641 ’ to the second portion 641”.
In the embodiment shown in fig. 17, the first portion 641’ is detachably connected to the connecting portion 642, and the second portion 641 ” is detachably connected to the connecting portion 642. The remote unit 600 is enclosed in a housing having a first portion made from titanium and a second portion made from a ceramic material. The portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material for communication and or energy transfer using wireless signals.
As is further described with reference to fig. 17, in the embodiment of fig. 17, a controller 300 and an implantable energy storage unit is placed in the second portion 641”. Further features and functions of the controller 300 and implantable energy storage unit are further described with reference to figs. 57A - 57N.
The abdominal wall AW is in most locations generally formed by a set of layers of skin, fat/fascia, muscles and the peritoneum. The deepest layer in the abdominal wall AW is the peritoneum PT, which covers many of the abdominal organs, for example the large and small intestines. The peritoneum PT is a serous membrane composed of a layer of mesothelium supported by a thin layer of connective tissue and serves as a conduit for abdominal organ’s blood vessels, lymphatic vessels, and nerves. The area of the abdomen enclosed by the peritoneum PT is called the intraperitoneal space. The tissue and organs within the intraperitoneal space are called "intraperitoneal" (e.g., the stomach and intestines). The tissue and organs in the abdominal cavity that are located behind the intraperitoneal space are called "retroperitoneal" (e.g., the kidneys), and tissue and organs located below the intraperitoneal space are called "subperitoneal" or "infraperitoneal" (e.g., the bladder).
The peritoneum PT is connected to a layer of extraperitoneal fat EF which is connected to a layer or transversalis fascia TF. Connected to the transversalis fascia TF, at the area of the abdominal wall AW at which the section is extracted, is muscle tissue MT separated by layers of deep fascia DF. The deep fascia DF between the layers of muscle is thinner than the transversalis fascia TF and the Scarpa’s fascia SF placed on the outside of the muscle tissue MT. Both the transversalis fascia TF and the Scarpa’s fascia SF are relatively firm membranous sheets. At the area of the abdominal wall AW at which the section is extracted, the muscle tissue MT is composed of the transverse abdominal muscle TM (transversus abdominis), the internal oblique muscle IM (obliquus intemus) and the external oblique muscle EM (obliquus extemus). In other areas of the abdominal wall AW, the muscle tissue could also be composed of the rectus abdominis and the pyramidalis muscle.
The layer outside of the muscle tissue MT, beneath the skin SK of the patient is called subcutaneous tissue ST, also called the hypodermis, hypoderm, subcutis or superficial fascia. The main portion of the subcutaneous tissue ST is made up of Camper’s fascia which consists primarily of loose connective tissue and fat. Generally, the subcutaneous tissue ST contains larger blood vessels and nerves than those found in the skin.
Placing the remote unit 600 at an area of the abdomen is advantageous as the intestines are easily displaced for making sufficient room for the remote unit 600, without the remote unit 600 affecting the patient too much in a sensational or visual way. Also, the placement of the remote unit 600 in the area of the abdomen makes it possible to fixate the remote unit 600 to the muscle tissue MT of the abdomen for creating an attachment keeping the remote unit 600 firmly in place. In the embodiment shown in fig. 17, the first portion 641’ of the remote unit 600 is placed on the left side of the patient in between the peritoneum PT and the muscle tissue MT. The first portion 641’ is placed in the subcutaneous tissue ST between the muscle tissue MT and the skin SK of the patient. Placing the first portion 641’ subcutaneously enables easy access to the first portion 641’ for e.g. wireless communication using a wireless transceiver placed in the first portion 641’, wireless charging of an implantable storage unit using a wireless energy receiver placed in the first portion 641’, injection of a hydraulic fluid (relevant when the operation device is a hydraulic operation device), into an injection port placed in the first portion 641’, manual manipulation of for example a push button placed in the first portion 641 ’, or maintenance or replacement of the first portion 641 ’ via a small incision in the skin SK at the first portion 641’.
In the embodiment shown in fig. 17, the connecting portion 642 connects the first and second portions 641 ’,641” though three layers of muscle tissue MT, namely tissue of the transverse abdominal muscle TM, the internal oblique muscle IM and the external oblique muscle EM. In alternative embodiments, it is however conceivable that the second portion 641 ” is placed in between layers of muscle, such as between tissue of the transverse abdominal muscle TM, the internal oblique muscle IM, or between the internal oblique muscle IM and the external oblique muscle EM. As such, it is conceivable that in alternative embodiments, the connecting portion 642 connects the first and second portions 641 ’,641” through two layers of muscle tissue MT, or through one layer of muscle tissue MT.
In alternative embodiments, it is furthermore conceivable that the first portion 641 ’ is placed in between layers of muscle, such as between tissue of external oblique muscle EM and the internal oblique muscle IM, or between the internal oblique muscle IM and the transverse abdominal muscle TM.
In the embodiment shown in fig. 17, a major portion of the remote unit 600 is placed at a distance exceeding 80mm from a major portion of the adjustable vessel member 100, more specifically, a major portion of the remote unit 600 is placed at a distance exceeding 100mm from a major portion of the adjustable vessel member 100, even more specifically a major portion of the remote unit 600 is placed at a distance exceeding 140mm from a major portion of the adjustable vessel member 100, and even more specifically, a major portion of the remote unit 600 is placed at a distance exceeding 200mm from a major portion of the adjustable vessel member 100.
The embodiment shown in fig. 17 is a hydraulic embodiment in which the adjustable vessel member 100 is a hydraulically adjustable vessel member 100. The hydraulically adjustable vessel member 100 is then operated by a hydraulic operation device comprising a hydraulic pump and optionally at least one hydraulic valve. The hydraulic pump is placed in the remote unit 600 and as such, the remote unit 600 comprises at least a portion of the operation device and could for example be any of the hydraulic pumps 604 described with reference to figs. 46A - 50.
The remote unit 600 is connected to the adjustable vessel member via a connection/attachment device 650 comprising a hydraulic conduit for transferring force hydraulically from the remote unit 600 to the adjustable vessel member, for operating the adjustable vessel member. The connection/attachment device 650 comprising a hydraulic conduit run between the peritoneum PT and the muscle tissue MT vertically until connection/attachment device 650 reaches the height of the major portion of the adjustable vessel member 100. At this height, the connection/attachment device 650 enters the peritoneum PT and travels substantially horizontally to the adjustable vessel member 100. As such, the connection/attachment device 650 is placed inside of the intraperitoneal space for as short distance as possible which reduces the risk that implanted, foreign body elements disturb the intraperitoneal organs, reducing the risk of damage to organs, and reducing the risk that foreign body elements cause ileus.
In embodiments in which the operation device also comprises at least one valve for controlling the flow of hydraulic fluid from the hydraulic pump to the adjustable vessel member 100, such valve may be placed in, or in close proximity to, the adjustable vessel member 100. As such, the adjustable vessel member 100 may comprise at least a part of the operation device. It may however also be so that at least one valve is placed in the remote unit 600, or that the operation device comprises valves in both the adjustable vessel member 100 and the remote unit 600.
The connection/attachment device 650 further comprises at least one lead for transferring electrical energy and/or information from the remote unit 600 to the adjustable vessel member 100. The information could be control signals to the adjustable vessel member 100 or sensor input or outer feedback from the adjustable vessel member 100 to the remote unit 600.
In alternative embodiments of the implantable system, the vessel member 100 is a mechanically adjustable vessel member and/or a vessel member configured to be operated by a mechanical operation device, such as for example disclosed with reference to figs. 25A and 25B. In such embodiments, the part of the operation device comprised in the adjustable vessel member 100 comprises a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on a blood vessel. The receiving portion may be configured to receive a linear mechanical force or may be configured to receive a rotating mechanical force and transform the received rotating mechanical force into a liner mechanical force for acting on the blood vessel. A mechanical operation device may further comprise a gear system configured to reduce the velocity and increase the force of the received mechanical force.
In a mechanical operation device, the operation device placed in the remote unit may comprise an electrical motor, which may be connected to a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor. In the alternative, the implantable system may comprise a hydraulic/mechanical operation device in which a portion of the operation device is placed in the adjustable vessel member 100 and comprises a receiving portion configured to receive hydraulic force, such as described in relation to the embodiment shown in fig. 17. The portion of the operation device is placed in the adjustable vessel member 100 could then further comprise a transmission for transforming the received hydraulic force into a mechanical force for exerting a pressure on the vessel. Such transmission could for example be at least one hydraulic cylinder.
In an alternative embodiment, the adjustable vessel member could comprise bands comprising an elastic material, and the adjustable vessel member could be adapted to exert a mechanical pressure by the elastic properties of the elastic material.
Fig. 18A shows a lateral, sectional view of the heart H, the thoracic portion of the aorta 20, including the aortic arch 30, as well as the rib cage comprising the ribs R and the sternum S. The vessel member 100 is in the embodiment of fig. 18A placed between the heart and the Brachiocephalic artery 29 at an area of an aneurysm on the aorta at the artic arch 30. The vessel member 100 is fixated to an attachment device for attaching the vessel member 100 to a portion of the body of the patient, more specifically in the embodiment of fig. 18A to the sternum S of the patient. The attachment device comprises an elongated distance element 185, connecting the vessel member 100 to a fixation plate 183 configured for fixation to the sternum S, on the posterior side thereof (inside). The fixation plate 183 could be fixated to cortical bone of the sternum S with the use of orthopedic screws. The elongated distance element 185 may be somewhat resilient for absorbing movements between the rib cage and the heart H created by the patient breathing.
Fig. 18B shows an embodiment similar to that of fig. 18A, the difference being that the elongated distance element 185 travels through a through-hole in the sternum S for fixation to a fixation plate 183 configured to be placed on the anterior side (outside) of the sternum S.
Fig. 18C shows an embodiment similar to that of fig. 18A, the difference being that the vessel member 100 comprises a first and second portion/segment 120a, 120b. The first portion/segment 120a is fixated to a first elongated distance element 185a, connecting the first portion/segment 120a to a first fixation plate 183a configured for fixation to the sternum S, on the posterior side thereof (inside). The second portion/segment 120b is fixated to a second elongated distance element 185b, connecting the second portion/segment 120b to a second fixation plate 183b configured for fixation to the sternum S, on the posterior side thereof (inside).
Fig. 18D shows an embodiment similar to that of fig. 18A, the difference being that the vessel member 100 comprises a first, second and third portion/segment 120a, 120b, 120c. The first portion/segment 120a encircles the aorta 20 between the heart H and the Brachiocephalic artery 29, the second portion/segment 120b comprises an opening for accommodating the Brachiocephalic artery 29, and the third portion/segment 120c encircles the aorta 20 between the Brachiocephalic artery 29 and the left common Carotid artery 28. The first portion/segment 120a is fixated to an elongated distance element 185, connecting the first portion/segment 120a to a fixation plate 183 configured for fixation to the sternum S, on the posterior side thereof (inside). The second portion/segment 120b is fixated to the first portion/segment and the third portion/segment is fixated to the second portion/segment. As such, the entire vessel member 100 is fixated by means of a single attachment device fixated to the first portion/segment 120a. I.e. the other segments of the vessel member 100 are attached to the sternum S indirectly by means their direct or indirect connection to the first segment 120a fixated with the attachment device to the sternum S.
Fig. 18E shows an embodiment similar to that of fig. 18A, the difference being that the elongated distance element 185 is fixated to a fixation plate 183 configured to be placed on the posterior side (inside) of a rib R. The fixation plate 183 could be fixated to cortical bone of the rib R with the use of orthopedic screws. The elongated distance element 185 may be somewhat resilient for absorbing movements between the rib cage and the heart H created by the patient breathing.
Fig. 19A shows an implantable system for handling an aneurysm in a blood vessel of a patient, when the system has been implanted in the body of the patient for handling an aneurysm at the aorta 20 of the patient, more specifically, at the aortic arch 30 of the patient. In the embodiment of fig. 19A, the system comprises a vessel member 100, which is a hydraulically adjustable vessel member 100 positioned on the aorta 20 at the aortic arch 30 of the patient, in the thoracic portion of the aorta 20. The vessel member 100 partially encloses the aorta 20 in a region of an aneurysman on the aortic arch 30.
In the embodiment of fig. 19A, the vessel member comprises a first, second and third segment 120a, 120b, 120c, being placed at different portions of the aortic arch 30. Each of the first, second and third segment 120a, 120b, 120c, comprises an enclosing cross-sectional area perpendicular to the direction of the length extension LE of the aorta 20, the enclosing cross- sectional area being configured for at least partially enclosing a portion of the aorta 20. The distance between the inner surface of each of the segments 120a, 120b, 120c and the outer surface of the aorta 20, or the pressure exerted on the aorta by the segments of the adjustable vessel member 100 is altered by altering the size of the enclosing cross-section area.
In the embodiment shown in fig. 19A, the first, second and third segments 120a, 120b, 120c, are not connected to each other, instead, the first, second and third segments 120a, 120b, 120c, are individually connected to one or more hydraulic operation devices by means of a first, second and third connection 650a, 650b, 650c, each comprising a hydraulic conduit for transferring force hydraulically to a hydraulic cuff placed on the inner surface of each of the first, second and third segments 120a, 120b, 120c. The hydraulic operation device could be any of the hydraulic operation devices disclosed herein, and the hydraulic operation device could be controlled by an implantable controller according to any of the embodiments discloses herein, for adjusting the volume in the hydraulic cuffs, or pressure exerted by the hydraulic cuffs. Features and functions of the hydraulic operation device and the implantable controller is further described with reference to figs.46A - 50 and 57A - 57N.
As the first, second and third segments 120a, 120b, 120c, are individually connected to the hydraulic operation device(s), the pressure and/or amount of fluid in each of the first, second and third segments 120a, 120b, 120c can be individually adjusted. As such, the first segment 120a can exert a first pressure on the aorta 20, and the second segment can exert a second pressure on the aorta 20, and the third segment can exert a third pressure on the aorta 20.
In the embodiment shown in fig. 19A, the first segment 120a encircles the aorta 20 between the heart H and the Brachiocephalic artery 29, the second segment 120b encircles the aorta 20 between the Brachiocephalic artery 29, and the left common Carotid artery 28, and the third segment 120c encircles the aorta 20 after the left Subclavian artery 27, in the direction of the descending aorta. As such, the Brachiocephalic artery 29 can thus freely branch between the first and second segments 120a, 120b, and the left common Carotid artery 28 and the left Subclavian artery 27 can freely branch between the second segment 120b and the third segment 120c.
In the embodiment shown in fig. 19A, to be able to be placed at the positions as shown in fig. 19A, the first segment 120a has a width in the range 3mm - 15mm (in the direction of the length extension LE of the aorta 20), the second segment 120b has a width in the range 3mm - 10mm, and the third segment 120c has a width in the range 3mm - 20mm.
The aortic arch 30 has a curvature in the direction of the length extension LE of the aorta 20. Each of the segments 120a, 120b, 120c of the adjustable vessel member 100 comprises an inner surface configured to face an outer surface of the aorta 20 and being adapted to accommodate the curvature in the direction of the length extension LE of the aorta 20.
Each of the segments 120a, 120b, 120c of the adjustable vessel member 100 could either be configured to be placed at a distance from the aorta, such that the inner surfaces of each of the segments 120a, 120b, 120c does not engage the outer surface of the aorta 20, or in the alternative, be configured to engage the outer surface of the aorta to exert a withholding force or pressure against the outer wall of the aorta, in a region of an expanding aneurysm on the aorta 20. Preferably, as described in other sections of this description, the adjustable vessel member 100 may be adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient, such that a counterforce can be exerted without risking hampering the blood flow and thereby the saturation of the tissue wall of the aorta.
In the embodiment shown in fig. 19A, the first, second and third segments 120a, 120b, 120c all comprises hydraulically inflatable cuffs for altering the distance between the inner surfaces of the segments and the outer surface of the aorta 20, or the pressure exerted on the outer surface of the aorta 20. However, it is equally conceivable that the first, second and third segments 120a, 120b, 120c of the vessel member comprises an elastic material and as such are capable of exerting a mechanical pressure on the outer surface of the aorta 20 by the elastic properties of the elastic material. It is also equally conceivable that the first, second and third segments
120a, 120b, 120c of the vessel member each comprises mechanical operation devices for altering the distance between the inner surfaces of the segments 120a, 120b, 120c of the vessel member and the outer surface of the aorta 20, or the pressure exerted by the segments 120a, 120b, 120c on the outer surface of the aorta 20. The mechanical operation devices could for example comprise electrical motors. Features and functions of the mechanically or elastically operable vessel members and the mechanical operation devices are further described with reference to figs. 24B - 25C and 26A - 50 Fig. 19B shows an embodiment similar to the embodiment shown in fig. 19 A, the difference being that in the embodiment of fig. 19B, the vessel member 100 is a single vessel member 100 having a plurality of portions P1,P2,P3,P4,P5. The portions are portions of the same single vessel member 100 and are materially integrated. The single vessel member 100 has the shape of is a bent channel configured to be placed around a portion of the aorta 20 in the region of the aortic arch 30 and comprises openings 110a, 110b in the form of through holes for accommodating branching blood vessels 29,28,27 connected to the aorta.
More specifically, in the embodiment shown in fig. 19B, the first portion Pl of the vessel member 100 encircles the aorta 20 and is positioned between heart H and the Brachiocephalic artery 29. To be suitible for placement between the heart H and the Brachiocephalic artery 29, the first portion Pl has a width in the range 3mm - 15mm, in the direction of the length extension LE of the aorta 20. The second portion P2 partially encircles the aorta 20 and comprises a first opening 110a for accommodating the Brachiocephalic artery 29. The second portion P2 has a width in the range 8mm - 18mm, in the direction of the length extension LE of the aorta 20, and as such, the first opening 110a also has a width in the range 8mm - 18mm to be able to accommodate the Brachiocephalic artery 29. The third portion P3 of the vessel member 100 encircles the aorta 20 and is positioned between the Brachiocephalic artery 29 and the left common Carotid artery 28. To be suitible for placement between the Brachiocephalic artery 29 and the left common Carotid artery 28, the third portion P3 has a width in the range 3mm - 15mm, in the direction of the length extension LE of the aorta 20. The fourth portion P4 partially encircles the aorta 20 and comprises a second opening 110b in the form of an elongated slit for accommodating both the left common Carotid artery 28 and the left Subclavian artery 27. The second portion P2 has a width in the range 25mm - 45mm, in the direction of the length extension LE of the aorta 20, and as such, the second opening 110b also has a width in the range 25mm - 45mm to be able to accommodate both the left common Carotid artery 28 and the left Subclavian artery 27. The fifth portion P5 encircles the aorta 20 after the left Subclavian artery 27, in the direction of the descending aorta.
The vessel member 100 of the embodiment shown in fig. 19B as a hydraulically adjustable vessel member 100 connected to a hydraulic operation device by means of a connection 650 comprising a hydraulic conduit for transferring force to a hydraulic cuff placed on the inside of the vessel member 100 for engaging the outside of the aorta 20 for treatment or monitoring of an aneurysm. The vessel member 100 could comprise a single hydraulic cuff, or a plurality of hydraulic cuffs, depending on the location and severity of the aneurysm.
Fig. 19C shows an embodiment similar to the embodiment shown in fig. 19A, the difference being that in the embodiment of fig. 19C, the connection 650 comprising the hydraulic conduit is connected to the third segment 120c. The implantable system then comprises a second hydraulic conduit 65 lb for creating a fluid connection between the third segment 120c and the second segment 120b, and a first hydraulic conduit 651a for creating a fluid connection between the second segment 120b and the first segment 120a. The first and second hydraulic conduits 65 la, 65 lb also comprise electric leads for transferring electrical signals to and from the first and second segments 120a, 120b, via the third segment 120c, to an implantable controller controlling the adjustment of the adjustable vessel member 100. The electrical signals may be signals containing information from at least one sensor placed in the first and/or second segment 120a, 120b, the details of which are further described with reference to figs. 51 A - 5 IE.
Each of the first, second and third segments 120a, 120b, 120c comprises at least one control valve for controlling the flow of hydraulic fluid between the three segments 120a, 120b, 120c, such that the hydraulic cuffs of the first, second and third segments 120a, 120b, 120c can be individually adjusted.
In the embodiment shown in fig. 19C, the connection between the first and second segments 120a, 120b, and between the second and third segments 120b, 120c, are fluid conduits creating a fluid connection. However, in alternative embodiments, the connection may be a connection for transferring electrical or mechanical energy for mechanically or electrically operating cuffs for exerting force on the aorta 20.
Figs. 20A, 20B and 20C shows an embodiment of a vessel member 100 in which the vessel member 100 is configured to be placed around and follow a blood vessel having a curvature, such as the aortic arch. The vessel member 100 has an inner portion IP and an outer portion OP. In embodiments where the curved vessel member of figs. 20A,20B,20C are configured to be placed on the artic arch, the inner portion IP is configured to be placed proximal to the heart of the patient and the outer portion OP is configured to be placed distal to the heart of the patient. The inner portion IP has an inner length IL in the direction of the length extension LE of the aorta, and the outer portion OP has an outer length OL in the direction of the length extension LE of the aorta. The outer length OL is longer than the inner length IL. In the embodiment shown in fig. 20A, the vessel member 100 is configured to be placed on the aortic arch of the patient, and the inner length IL is the length placed most proximal to the heart of the patient, and the outer length OL is the length placed most distal to the heart of the patient, when the vessel has been implanted around the aorta at the aortic arch of the patient.
In the embodiment shown in figs. 20A - 20C, the outer length OL is more than 1,2 times the length of the inner length IL, more specifically, more than 1,5 times the length of the inner length IL. In the embodiment shown in figs. 20A - 20C, the outer length OL is more than 2mm and the inner length IL is more than 4 mm, more specifically, the outer length is more than 3mm and the inner length is more than 6mm.
Fig.20B shows a sectional view of the curved vessel member 100 shown in figs. 20A, 20B and 20C. The curved vessel member 100 has a first inner surface 121’ within the outer portion OP having a first curvature C 1 configured to follow the curvature of the aortic arch in the direction of the length extension LE of the aorta. The curved vessel member 100 further has a second inner surface 121” within the inner portion IP having a third curvature C3 configured to follow the curvature of the aortic arch in the direction of the length extension LE of the aorta. The inner portion IP, and thus the third curvature C3, is configured to be placed proximal to the heart of the patient, and the outer portion OP, and thus the first curvature Cl, is configured to be placed distal to the heart of the patient. As such, the aorta is placeable between the first and third curvatures C1,C3. The first curvature Cl has a first radius rl and the third curvature C3 has a third radius r3. The first radius rl is larger than the third radius r3. More specifically, in the embodiment shown in figs. 20A - 20C, the first radius rl is at least 1,5 times the third radius r3.
To be able to accommodate the aortic arch of the aorta, in the embodiment of the vessel member 100 shown in the embodiment of figs. 20A - 20C, the first radius rl is in the range 8mm - 45mm, more specifically in the range 10mm - 40mm, and even more specifically in the range 12mm - 35mm, and the third radius r3 is in the range 5mm - 25mm, more specifically in the range 6mm - 20mm, and even more specifically in the range 8mm - 20mm.
Fig. 20C shows a cross-sectional view A - A of the section of fig. 20b, i.e. showing half of the vessel member in a sectional side view, looking in the direction of the length extension LE. In fig, 20C it is clearly seen that the vessel member 100 has a second curvature C2 configured to follow a curvature of the circumference of the aorta, in a cross-sectional plane perpendicular to the length extension LE of the aorta. I.e., the aorta is a tube shaped blood vessel with a circular circumference and the vessel member 100 is configured to follow the circular circumference by means of the second curvature C2 of the vessel member 100. The second curvature has a second radius r2. In the embodiment shown in figs. 20A - 20C the second radius is in the range 3mm - 25mm, depending on the size of the patient and the anatomy of the aneurysm. More specifically, the second radius is in the range 4mm - 15mm, and even more specifically, the second radius is in the range 6mm - 12mm.
In the embodiment shown in figs. 20A - 20C, the first radius rl is at least 1,5 times the third radius r3, more specifically, the first radius rl is at least 2 times the second radius r2.
In the embodiment shown in figs. 20A - 20C, the third radius r3 is at least 1,5 times the second radius r2.
Fig. 21 shows an embodiment similar to the embodiment shown in figs. 20A - 20C, with the difference that in the embodiment shown in fig. 21, the outer portion OP is a first part 140a and the inner portion IP is a second part 140b. The first and second parts 140a, 140b are configured to be connected by means of protrusions 135 on the first part 140a and corresponding recesses 136 on the second part 140b, for forming a connected vessel member 100. The separation of the first part 140a, from the second part 140b enables the vessel member to be opened for being introduced onto the aorta from opposite sides during implantation and placement of vessel member 100, such that the vessel member 100 can enclose the aorta when in place. The joint between the first and second parts 140a, 140b is substantially parallel to the direction of the blood flow in the aorta.
The first segment 120a comprising the outer portion OP is configured to be placed distal to the heart of the patient, and the second segment 120b comprising the inner portion IP is configured to be placed proximal to the heart of the patient. The inner portion IP has an inner length IL in the direction of the length extension, and the outer portion OP has an outer length OL in the direction of the length extension of the aorta, and the outer length OL is longer than the inner length IL.
Fig. 22 shows one embodiment of the implantable system similar to that of figs. 20A - 20C, the difference being that in the embodiment of fig. 22, the outer portion OP of the vessel member 100 comprises a first straight line 141a extending along a first axis Al on the inner surface 121a’ of the first portion Pl, and a second straight line 141b extending along a second axis A2 on the inner surface 121a” of the second portion P2. The first straight line 141a is connected to the second straight line 141b, and the first straight line 141a is angled with a first angle a in relation to the second straight line 141b. Further, the inner portion IP of the vessel member 100 comprises a third straight line 141c extending along a third axis A3 on the inner surface 121b’ of the first portion Pl, and a fourth straight line 14 Id extending along a fourth axis A4 on the inner surface 121b” of the second portion P2. The third straight line 141c is connected to the fourth straight line 14 Id, and the third straight line 141c is angled with a second angle P in relation to the fourth straight line 14 Id. The first straight line 141a and the third straight line 141c extends on opposite sides of the aorta. To accommodate the bend of the aortic arch, the first angle a is different than the second angle , more specifically, the first angle a is smaller than the second angle p. In the embodiment shown in fig. 22, the first angle a is more than 3° smaller than the second angle P, more specifically, the first angle a is more than 5° smaller than the second angle p. In the embodiment shown in fig. 22, the first angle a is in the range 3° - 90°, more specifically in the range 5° - 45°, and even more specifically in the range 10° - 45°. In the embodiment shown in fig. 22, the first straight line has a length exceeding 4mm and the second straight line has a length exceeding 4mm.
In the embodiment shown in fig. 22, the portions P1,P2 of the vessel member are portions of a single vessel member 100 which is materially integrated in a single piece. However, it is equally conceivable that the two portions are portions on different segments, such as for example described with reference to fig. 4A - 5F and fig. 23, in which case the first segment is angled in relation to the second segment, such that the adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension LE of the aorta.
Figs. 23A and 23B shows an implantable system for handling an aneurysm in a blood vessel of a patient. In the embodiment shown in figs. 23A and 23B, the system comprises an adjustable vessel member 100 comprised of five segments 120a, 120b, 120c, 120d,120e forming a connected vessel member 100 configured to enclose a portion of the aorta at the aortic arch of the patient. The five segments 120a, 120b, 120c, 120d,120e are displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension LE of the aorta. In the embodiment shown in fig. 23, the fifth segment 120e is parallelly displaced in relation to the fourth segment 120d with a distance Dil, and the fourth segment 120d is parallelly displaced in relation to the third segment 120c with a distance Di2. The distances Dil and Di2 both being in the range 0,5mm - 10mm. To accommodate the left Subclavian artery 27, the fourth and fifth segments 120d,120e both comprises openings 11 Od, 1 lOe.
Each of the segments 120a - 120e comprises connection interfaces for connecting to each other such that the connected vessel member can be formed. The first segment 120a comprises a connection interface in the form of connecting protrusions 135 connectable to connection recesses 136 in the second segment 120b. The second segment 120b comprises a connection interface in the form of connecting recesses 136 for receiving the connecting protrusions 135 of the first segment 120a and connecting protrusions 135 connectable to connection recesses 136 in the third segment 120c. The third segment 120c comprises a connection interface in the form of connecting recesses 136 for receiving the connecting protrusions 135 of the second segment 120b and connecting protrusions 135 connectable to connection recesses 136 in the fourth segment 120d. The fourth segment 120d comprises a connection interface in the form of connecting recesses 136 for receiving the connecting protrusions 135 of the third segment 120c and connecting protrusions 135 connectable to connection recesses 136 in the fifth segment 120c, and lastly, the fifth segment 120e comprises a connection interface in the form of connecting recesses 136 for receiving the connecting protrusions 135 of the fourth segment 120d.
The segments 120a - 120e are connected to each other such that the joint between the segments 120a - 120e is more perpendicular than parallel to the length extension and thereby the direction of the blood flow in the aorta. More specifically, the joint between the segments 120a - 120e is substantially perpendicular to the direction of the length extension.
When assembled, the connected adjustable vessel member covers a distance in the range 5mm - 100mm of the aorta in the direction of length extension LE of the aorta, in the region of the aortic arch. More specifically, the connected adjustable vessel member covers a distance in the range 10mm - 70mm, and even more specifically, the connected adjustable vessel member covers a distance in the range 20mm - 50mm. In the embodiment shown in figs. 23A and 23B, the first and second segments 120a, 120b has a width W1 (could also be expressed as length in the direction of the length extension LE of the aorta 20), in the range 3mm - 10mm and the third segment 120c has a width of 2*W1, thus being in the range 6mm - 20mm. As such, the third segment has a width which is at more than 1,2 times the width of the second segment 120b, more specifically, the third segment 120c has a width which is two times the width of the second segment 120b.
In the embodiment shown in figs. 23A and 23B, the first segment 120a of the adjustable vessel member 100 comprises a first enclosing cross-sectional area 126a, extending in a cranial- caudal direction, substantially perpendicular to the direction of the length extension LE of the aorta. The first enclosing cross-sectional area 126a is configured for enclosing a portion of the aorta 20. The third segment 120c of the adjustable vessel member 100 comprises a third enclosing cross- sectional area 126c parallel to the first enclosing cross-sectional 126a. The third enclosing cross- sectional 126c is configured for enclosing another portion of the aorta 20. The first enclosing cross- sectional area 126a is larger than the third enclosing cross-sectional area 126c, as the aorta 20 bends more at the portion enclosed by the first enclosing cross-sectional area 126a, and as such has a larger cross-sectional area. The difference in the size of the cross-sectional area may also depend on the anatomy of the aorta and the particular aneurysm.
Fig. 24A shows an implantable system for handling an aneurysm in a blood vessel of a patient. The system of fig. 24 comprises a vessel member 100 similar to the vessel member disclosed with reference to fig. 5E, the difference being that in the embodiment of fig. 24A, the vessel member 100 is configured to, in a first state of the blood vessel 20, be positioned such that the inner surface 121a - 121c of the vessel member 100 is placed at a distance DS from the outer surface of the blood vessel 20, such that the inner surface 121a - 121c of the vessel member 100 does not engage the outer surface of the blood vessel 20. In a second state of the blood vessel, when the aneurysm on the blood vessel 20 expands, the inner surface 121a - 121c of the vessel member 100 is configured to engage the outer surface of the blood vessel 20, for supporting the blood vessel by withholding the expansion. The implantable system of fig. 24A further comprises an attachment device 182 for attaching the vessel member 100 to a structure in the patient’s body (such as a bone or tissue structure, for example further described with reference to figs. 13A - 14). By the attachment device holding the vessel member 100 in place, the distance DS between the inner surface 121a - 121c of the vessel member 100 and the outer surface of the blood vessel 20 can be maintained while the blood vessel 20 is in the first state.
In the embodiment shown in fig. 24A, the inner surface 121a - 121c of the vessel member 100 is configured to be placed at a distance from the outer surface of the blood vessel in the range 0,5mm - 10mm, more specifically, at a distance from the outer surface of the blood vessel in the range 1mm - 5mm. The inner surface 121a - 121c of the vessel member 100 of the embodiment of fig. 24A comprises a resilient material. The resilient material has a Young’s modulus of less than 200 MPa and/or a hardness of less than 100 Shore A.
In the embodiment shown in fig. 24A, the resilient material is a silicone-based polymer material, such that the blood vessel 20 is not harmed by the inner surface 121a - 121c engaging the blood vessel.
As the inner surface 121a - 121c, normally is placed at a distance from the outer surface of the blood vessel 20 the risk of harming the blood vessel 20 or hampering the saturation of the tissue wall of the blood vessel 20 is reduced, which is advantageous for long term placement of the vessel member. Long term connection with the blood vessel 20 creates a risk of the vessel member 100 migrating into the tissue wall, which increases the risk that the aneurysm will burst. The engagement also risks reducing the blood flow in the tissue wall itself, thus reducing oxygenation of the tissue wall, which risks weakening the tissue wall of the blood vessel 20 overtime.
The vessel member of the embodiment shown in fig. 24A can be partially opened for being introduced over the blood vessel 20 by means of a pivot joint (not shown).
The vessel member of the embodiment shown in fig. 24A is made up of a first, second and third segment 120a, 120b, 120 connected to each other for forming the vessel member. The first segment 120a comprises a first curvature Cl configured to be placed in the direction of the length extension LE of the blood vessel 20, such that the inner surface 121a can follow a curvature of the blood vessel 20. The second segment 120b comprises a second curvature C2 configured to be placed in the direction of the length extension LE of the blood vessel 20, such that the inner surface 121b can follow a curvature of the blood vessel 20. The third segment 120c comprises a third curvature C3 configured to be placed in the direction of the length extension LE of the blood vessel 20, such that the inner surface 121c can follow a curvature of the blood vessel 20.
The three curvatures C1,C2,C3 could be curvatures having the same radii, or could, as is the case in the embodiment shown in fig,. 24A, have different radii to follow the curvature of an aneurysm which in most cases is not uniform.
In the embodiment shown in fig. 24, the implantable system further comprises a sensor placed on the inner surface 121a of the first segment 120a of the vessel member 100. The sensor is a contact sensor measuring the expansion of the aneurysm by indicating when the aneurysm has expanded such that the outer surface has been placed in contact with the inner surface 121a of the vessel member 100. The sensor is an electrical sensor operating by sensing a change in resistance between two conducting elements when the outer surface of the blood vessel is placed in connection with the conducting elements of the sensor. The sensor is in electrical connection with a controller 300 by means of a lead 474 for transferring a sensor signal to the controller 300. When the implantable controller 300 receives sensor signal in response to the outside of the vessel connecting to the sensor, the implantable controller creates a log entry in a memory of the implantable controller and wirelessly transmits a signal to an external unit to notify the patient and/or a medical professional that an expansion of the aneurysm has occurred.
In alternative embodiments, the sensor may be configured to sense a diameter or cross- sectional distance of a blood vessel, e.g. by optical or ultra sound technology, or a wall thickness of the blood vessel e.g. by optical or ultra sound technology, or a flow rate through a blood vessel, e.g. by optical or ultra sound technology (doppler). All of the alternative sensor technologies may also be used for informing the patient and/or medical professional that an expansion of the aneurysm has occurred.
Further embodiments of the sensor, the function and design of implantable controllers and the communication between the implantable controller and the external unit is described with reference to figs. 57A - 57N.
Fig. 24B shows an implantable system for handling an aneurysm in a blood vessel 20 of a patient. The system of fig. 24 comprises a vessel member 100 similar to the vessel member 100 disclosed with reference to fig. 24A, the difference being that in the embodiment of fig. 24B, the vessel member 100 is an adjustable vessel member for adjusting the distance DS between the inner surface 121a - 121c of the vessel member 100 and the outer surface of the blood vessel 20, and the pressure exerted by the vessel member 100 on the blood vessel 20. The adjustable vessel member 100 encloses an enclosing cross-sectional area perpendicular to the direction of the length extension LE of the blood vessel. The enclosing cross-sectional area encloses a portion of the blood vessel 20. The adjustable vessel member is configured to adjusting the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and when placed in engagement with the blood vessel 20, adjust the pressure exerted by the vessel member on the blood vessel, by the adjustable vessel member altering the size of the enclosing cross-section area.
In the embodiment shown in fig 24B, the inner surface 121a - 121c of the vessel member 100 comprises three inflatable portions in the form of three hydraulic cuffs 601a - 601c, each facing the outer surface of the blood vessel. The inner circumference of the cuffs 601a - 601c forms the outer circumference of the enclosing cross-sectional area. The hydraulic cuffs 601a - 601c are each connected to a hydraulic operation device comprising a control valve 660 by means of fluid conduits 65 la - 651c. The hydraulic cuffs 601a - 601c are individually hydraulically adjustable. The adjustable vessel member 100 encloses an enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel 20 and the pressure exerted by the adjustable vessel member on the blood vessel is altered by altering the size of the cross-section area enclosed by the cuffs 601a - 601c. The hydraulic cuffs 601a - 601c of the three segments 120a - 120c are each connected to the control valve 660 enclosed in a housing. The control valve 660 receives force in the form of pressurized hydraulic fluid from a connection 650 comprising a fluid conduit fluidly connecting the control valve 660 to a remote unit (such as further described with reference to figs. 3 and 17), which in turn comprises a hydraulic pump (for example any of the hydraulic pumps 604 described with reference to figs. 46A - 50) pressurizing the hydraulic fluid. The control valve controls and distributes hydraulic fluid via conduits 65 la - 651c to the hydraulic cuffs 601a - 601c, such that each of the hydraulic cuffs 601a - 601c can be individually adjusted for altering the distance between the hydraulic cuff 601a - 601c and the blood vessel and/or the pressure exerted on different portions of the blood vessel. The hydraulic pump and the control valve form part of the operation device for operating the adjustable vessel member. By having an individually adjustable system, the correct distance and/or pressure for a particular aneurysm and/or particular portion of the aneurysm can be applied. The system of individually adjustable cuffs 601a - 601c as shown in fig. 24B may be implemented in any of the embodiments of vessel members shown herein, and especially in the vessel members described with reference to figs. 4A - 14.
In the embodiment shown in fig. 24B, the implantable system comprises a first, second and third sensor 606a, 606b, 606c connected to an implantable controller 300 by means of electrical leads 474a, 474b, 474c. The sensors 606a, 606b, 606c are configured to sense an expansion of the aneurysm by sensing connection between the sensors 606a, 606b, 606c placed on the inner surface 121a - 121c of the vessel member 100 and the outer surface of the blood vessel 20 and send sensor signals by means of the leads 474a - 474c to the implantable controller 300 indicating to the controller that expansion has occurred, and at what portion 120a - 120c of the vessel member 100 the expansion has occurred.
The controller 300 of the implantable system of fig. 24B is configured to, in response to the receipt of a sensor signal indicating an expansion of the aneurysm has occurred, create a log entry in a memory of the implantable controller, wirelessly transmit a signal to an external unit to notify the patient and/or a medical professional that an expansion of the aneurysm has occurred, and control the adjustable vessel member 100 to increase the pressure in the hydraulic cuff at the position at which the expansion has occurred, to withhold the expansion for hindering further expansion of the aneurysm.
In the embodiment shown in fig. 24B, the implantable system may further comprise a second sensor (not shown) configured to sense a pressure in the inflatable cuffs 601a - 601c and/or a volume in the inflatable cuffs 601a - 601c (or in a fluid connection to the inflatable cuffs).
In the embodiment shown in fig. 24B, the implantable system may further comprise a third sensor incorporated in the controller 300 (not shown) and configured to sense a parameter related to the power consumption of the implantable system, which could be used as a parameter to determine the pressure exerted on the blood vessel 20, or a parameter related to a status of the energy storage unit or related to a wireless transfer of energy from a source external to the body of the patient. The status of the energy storage unit or wireless transfer of energy may be used for assessing the functional status of the implantable system to notify the patient or medical professional if anything is wrong with the device or if the implantable system needs charging or maintenance.
The implantable system according to the embodiment shown in fig. 24B may additionally comprise a hydraulic reservoir connected to the inflatable cuffs 601a - 601c functioning as a source of hydraulic fluid for the hydraulic operation device (including the remote pump and the control calve 660).
The implantable system according to the embodiment shown in fig. 24B may additionally comprise a sensor configured to sense at least one physiological parameter of the patient, which could be: an expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker. All of which could be signs of detreating health which may be related to or affect the expansion of the aneurysm.
The controller 300 is in the embodiment shown in fig. 24B configured to control the operation device to adjust the pressure in the hydraulic cuffs 601a - 601c, such that the hydraulic cuffs 601a - 601c exerts a pressure on the outer surface of the blood vessel in the range between a systolic and a diastolic blood pressure of the patient.
In the embodiment shown in fig. 24B, the vessel member 100 comprises a first part in the form of a first segment 120a, a second part in the form of a second segment 120b, and a third part in the form of a third segment 120c. The first, second and third parts are adapted to be connected to each other to form the vessel member, and the first, second and third parts are assembled such that the joints between the parts are more parallel than perpendicular to the direction of the length extension LE of the blood vessel 20.
In the embodiment shown in fig. 24B, for the purpose of the vessel member 100 being able to follow a curvature of the blood vessel 20 in the direction of the length extension LE of the blood vessel 20, the inner surface 121a of the first segment 120a has a first curvature Cl, the inner surface 121b of the second segment 120b has a second curvature C2 and the third segment 120c has a third curvature. However, in other embodiments, an inner surface of a first segment may be angled in relation to an inner surface of a second segment, and an inner surface of a second segment may be angled in relation to an inner surface of a third segment (further described with reference to fig. 11). Also in other embodiments, parts or segments may be displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel. This is further described with reference to figs. 23 A and 23B.
In the embodiment shown in fig. 24B, the vessel member 100 comprises an opening 110 for accommodating at least one branching blood vessel 1 connected to the blood vessel 20. The opening is in the form of a rectangular through-hole having a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 16mm2 - 100mm2. The distance between an edge of the opening 110 and the branching blood vessel 1 is in the range 1mm - 5mm.
Fig. 25A shows an embodiment of the implantable system for handling aneurysm, in an embodiment in which the vessel member 100 is very similar to the vessel member 100 of the embodiment of fig. 24B. The difference in the embodiment of fig. 25 A, is that in the embodiment of 25A, the implantable system comprises a mechanical operation device for mechanically adjusting the distance between the inner surface 121a - 121c of the vessel member 100 and the outer surface of the blood vessel 20, and the pressure exerted by the vessel member 100 on the blood vessel 20, when the inner surface 121a - 121c of the vessel member is placed in engagement with the outer surface of the blood vessel 20. The mechanical operation device is integrated with the vessel member 100, such that the operation device forms part of the vessel member 100. The operation device comprises three motors MO1,MO2,MO3 each being connected to an adjustable element configured for engaging the outer surface of the blood vessel 20, in the form of adjustable bands 656a,656b,656c made from a resilient polymer material (such as a silicone-based material, a polyurethane-based material, or a polymer material comprising PE of PTFE). The electrical motors MO 1 - MO3 have integrated gear systems configured to reduce the velocity and increase the force of the movement generated by the electrical motors MOI - MO3. Each of the adjustable bands 656a - 656c encloses an enclosing cross-sectional area perpendicular to the direction of the length extension LE of the blood vessel 20. Each of the enclosing cross-sectional areas encloses a portion of the blood vessel 20. The adjustable bands 656a - 656c are configured to adjust the distance between the inner surface of the vessel member 100 and the outer surface of the blood vessel 20, and when placed in engagement with the blood vessel 20, adjust the pressure exerted by the adjustable bands 656a - 656c on the blood vessel 20, by the adjustable bands 656a - 656c altering the size of the enclosing cross-section areas.
The first and third adjustable bands 656a, 656c completely encircles and encloses respective portions of the blood vessel 20, whereas the second adjustable band 656b only partially encircles and encloses a portion of the blood vessel, as the second adjustable band 656b comprises the opening 110 for accommodating a branching blood vessel 1 connected to the blood vessel 20. The second adjustable band 656b is divided into two portions, an end portion of each being fixated to the edges of the opening 110. The adjustable bands 656a - 656c are each connected to electrical motors MOI - MO3, each comprising a transmission for transforming a rotating force into a linear force. The transmissions comprise nut-portions 659 comprising internal threads. The nut-portions 659 are connected to the drive shafts of the electrical motors MOI - MO3 and thereby rotates along with the drive shafts. The transmissions further comprise screw-portions 657 having external threads that correspond to the internal threads of the nut-portions 659. The screw portions 657 thus performs a linear movement when the motors MOI - MO3 rotates. The screw-portions 657 are connected to the adjustable bands 656a - 656c such that the operation of motors MOI - MO3 pulls of releases the adjustable bands 656a - 656c altering the size of the enclosing cross-section areas enclosed by the adjustable bands 656a - 656c. In the embodiment shown in fig. 25A, the motors MOI - MO3 being part of the operation device are enclosed in a housing 484 integrated with the vessel member 100. The operation device is thus integrated with the vessel member 100. The operation device comprises an electrical connection 650 connecting the operation device with a remote member (such as further described with reference to figs. 3,17 and 26A - 45C) for providing the electrical motors MOI - MO3 with electrical energy.
Fig. 25B shows an embodiment of the implantable system for handling aneurysm, in an embodiment very similar to the embodiment described with reference to fig. 25A. The difference from the embodiment of fig. 25 A is that the vessel member 100 only comprises a first and a second individually adjustable band 656a, 656b, and the first and a second adjustable bands 656a, 656b are connected to force transferring elements in the form of flexible shafts in the form of Bowden cables 663a, 663b configured to transfer linear force from the remote unit 600 to the vessel member 100. The motors MOI and MO2 are placed in a remote unit 600. Just as in the embodiments of fig. 25 A, the motors M01,M02 in the remote unit 600 are connected to nut-and-screw transmission elements transferring the rotating force created by the motors M01,M02 to a linear force to be transferred by means of the Bowden cables 663a, 663b to the adjustable bands 656a, 656b of the vessel member 100. The electrical motors M01,M02 have integrated gear systems configured to reduce the velocity and increase the force of the movement generated by the electrical motors M01,M02. The Bowden cables 663a, 663b run in protective covers 667a, 667b comprising an inner sleeve for reducing the friction between the Bowden cables 663a, 663b and the protective covers 667a, 667b. Next, the protective covers 667a, 667b comprise a structure providing support and protection and being configured to manage some level of external compression without that affecting the movement of the Bowden cable 663a, 663b. The outermost layer of the protective covers 667a, 667b is a protective cover for sealing the Bowden cables 663a, 663b against the environment in the body of the patient. The protective covers 667a, 667b comprise a biocompatible flexible material, such as a biocompatible flexible polymer material, such as a silicone-based material, or a polyurethane- based material.
In the embodiment shown in fig. 25B, the remote unit 600 is configured to be placed at a distance exceeding 80mm from the center of gravity of the vessel member. The remote unit 600 comprises a first portion 64 T, a second portion 641 ”, and a connecting portion 642, mechanically connecting the first and second portions 641 ’,641”. The second portion 641” is in the embodiment shown in fig. 25B placed on the inside of muscular tissue MT of the abdominal wall of the patient, whereas the first portion 641 ’ is place on the outside of the muscular tissue MT of the abdominal wall, in the subcutaneous tissue ST. As such, the connecting portion 642 travels through a created hole or natural orifice of the muscular tissue MT. A cross-sectional area of the connecting portion 642, in a plane in the extension of the muscular tissue MT is smaller than a cross-sectional area of the first and second portions 641 ’,641”, parallel to the cross-sectional area of the connecting portion 642. The cross-sectional areas of the first and second portions 641 ’,641” are also larger than the created hole or natural orifice though which the connecting portion 642 is placed. As such, the first and second portions 641 ’,641 ” are unable to pass through the created hole or natural orifice and is as such fixated to the muscular tissue MT of the abdominal wall. In the embodiment shown in fig. 25B, the connecting portion 642, is a connecting portion having a circular crosssection and an axial direction extending from the first portion 641 ’ to the second portion 641”. The plane in the extension of the muscular tissue MT, is in the embodiment of fig. 25B perpendicular to the axial direction of the connecting portion 642 extending from the first portion 641 ’ to the second portion 641”. In the embodiment of fig. 25B, the first portion 641’ is detachably connected to the connecting portion 642, and the second portion 641 ” is detachably connected to the connecting portion 642.
In the embodiment of fig. 25B, the controller 300 is placed in the second portion 641”, and the implantable energy storage unit 40 is placed in the second portion 641”. Features and functions of the remote unit 600 are further described with reference to figs. 3, 17 and 26A - 45C. In alterative embodiments, both the controller and energy storage unit may be placed id direct connection to, or integrated in the vessel member 100. Further features and functions of the controller 300 and the implantable energy storage unit 40 are further described with reference to figs. 57A - 57N.
In alternative embodiments, the operation device could be a combination of a hydraulic and a mechanical operation device. The remote unit may comprise a hydraulic pump and/or a control valve system. Hydraulic fluid could then be conducted to a receiving portion of the vessel member configured to receive hydraulic force, by means of force transferring elements in the form of hydraulic conduits. The hydraulic force may then be transformed into a linear force for pulling and releasing the adjustable bands by means of for example a hydraulic cylinder. The remote unit 600 may further comprise a hydraulic reservoir for holding a hydraulic fluid and an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
Fig. 25C shows an embodiment of the implantable system for handling aneurysm in an alternative mechanical embodiment similar to that described with reference to fig. 25 A. In fig. 25 A, the implantable system comprises a mechanical operation device for mechanically adjusting the distance between contacting elements 674 on the inner surface of the vessel member 100, and the outer surface of the blood vessel 20, and for mechanically adjusting the pressure exerted by the contacting elements 674 of the vessel member 100 on the blood vessel 20. The mechanical operation device is integrated with the vessel member 100, such that the operation device forms part of the vessel member 100. The operation device comprises solenoids 675 in a set-up such that each contacting element 674 is connected to e solenoid (which is connected to a controller and energy storage unit placed in the vessel member 100 or placed in a remote unit). The three contacting elements are made from a resilient polymer material (such as a silicone-based material, a polyurethane-based material, or a polymer material comprising PE of PTFE). The solenoids 675 are individually controllable by the implantable controller, such that the solenoids 675 can exert different pressure on different portions of the blood vessel 20, such that the applied pressure or distance can be adapted for the particular aneurysm.
Fig. 25D shows an embodiment of the implantable system for handling aneurysm, in an embodiment very similar to the embodiment described with reference to fig. 25A. The difference from the embodiment of fig. 25 A is that the vessel member 100 comprises a first, second and third electrically adjustable bands 654a, 654b, 654c comprising an electroactive polymer which contracts when stimulated by an electric field, such as when a voltage placed over the band or a current is run through the band. Each of the electrically adjustable bands 654a, 654b, 654c encloses a cross- sectional area perpendicular to the direction of the length extension LE of the blood vessel, and each of the electrically adjustable bands 654a, 654b, 654c are configured to adjust the distance between the inner surface 121a - 121c of the vessel member 100 and the outer surface of the blood vessel 20, and the pressure exerted by the electrically adjustable bands 654a, 654b, 654c on the blood vessel, by the electrically adjustable bands 654a, 654b, 654c altering the size of the enclosing cross-section area.
The electrically adjustable bands 654a, 654b, 654c are each connected to an electrical operation device 653a, 653b, 653c for generating the electrical field required to contract the electrically adjustable bands 654a, 654b, 654c. The electrical operation device 653a, 653b, 653c are in turn connected by means of electrical leads 652a - 652c, to a source of energy (such as an implantable energy storage unit), which may be placed locally in the vessel member 100 or may be placed in a remote unit (such as a remote unit further described with reference to figs. 3,17 and 26A - 45C.
Fig. 25E shows an embodiment of the implantable system for handling aneurysm in an alternative electrical embodiment similar to that described with reference to fig. 25D. In fig. 25E, the vessel member 100 comprises a stimulation device 677 comprises a plurality of electrodes adapted to be placed in close connection to the aneurysm. The electrodes of the stimulation device 677 are adapted to provide an electrical stimulation pulse on a wall portion of the aneurysm. The electrical stimulation pulse can for example be generated by a pulse generator which may be placed in the vessel member on in a remote unit. The electrodes are adapted to stimulate the wall of the aneurysm at multiple stimulation points. The multiple stimulation points may be organized in different stimulation groups which can stimulate independently of each other. The electrical stimulation can be performed with positive and or negative voltage stimulation pulses. The sequence of electrical pulses used to stimulation the wall of the aneurysm can be applied with a predetermined periodicity having periods of no stimulation therein between during which periods without stimulation the wall of the aneurysm is allowed to rest. The electrical stimulation signal can also be Pulse Width Modulated to control the energy applied. The electrical stimulation may be applied during the systolic phase to increase the tonus of the wall of the aneurysm. The systolic phase can be detected by the sensors used to sense the pressure of the aneurysm as described above with reference to fig. 24A and 24B. The stimulation can be controlled to be applied with a temporarily increased intensity and position during emergency situations when the aneurysm is detected to rapidly expands, to limit the expansion of the aneurysm.
Figs. 26a, 26b and 27 show an embodiment of a remote unit 600 which may be used in combination with any of the hydraulically operable implantable systems for handling an aneurysm and hydraulically operable adjustable vessel members of such systems. The remote unit 600 is configured to be held in position by a tissue portion 610 of a patient, which may be a muscle tissue portion of the abdominal wall, such as further described with reference to fig. 17. The remote unit 600 comprises a first portion 641 ’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641 ’ having a first cross-sectional area A 1 in a first plane PL 1 and comprising a first surface 614 configured to face a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area A2 in a second plane PL2 and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 642 here has a third cross- sectional area A3 in a third plane PL3 and a fourth cross-sectional area A4 in a fourth plane PL4 and a third surface 624 configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610. The connecting portion 642 is configured to connect the first portion 641’ to the second portion 641”.
The connecting portion 642 thus has a portion being sized and shaped to fit through the hole in the tissue portion 610, such portion having the third cross-sectional area A3. Furthermore, the connecting portion 642 may have another portion being sized and shaped to not fit through the hole in the tissue portion 610, such portion having the fourth cross-sectional area A4. Likewise, the second portion 641” may have a portion being sized and shaped to not fit through the hole in the tissue portion 610, such portion having the second cross-sectional area A2. Thus, the connecting portion 642 may cooperate with the second portion 641 ” to keep the device in place in the hole of the tissue portion 610.
In the embodiment illustrated in Fig. 26a, the first portion 641’ is configured to detachably connect, i.e. reversibly connect to the connecting portion 642 by a mechanical and/or magnetic mechanism. In the illustrated embodiment, a mechanic mechanism is used, wherein one or several spring -loaded spherical elements 661 lock in place in a groove 603 of the connecting portion 642 when the first portion 641’ is inserted into the connecting portion 642. Other locking mechanisms are envisioned, including corresponding threads and grooves, self-locking elements, and twist and lock fittings.
The remote unit 600 is configured such that, when implanted, the first portion 641 ’ will be placed closer to an outside of the patient than the second portion 641”. Furthermore, in some implantation procedures the remote unit 600 may be implanted such that space will be available beyond the second portion, i.e. beyond the second side 618 of the tissue portion 610, whereas there may be as much space on the first side 612 of the tissue portion. Furthermore, tissue and/or skin may exert a force on the first portion 641” towards the tissue portion 610, and provide for that the second portion 641” does not travel through the hole in the tissue portion towards the first side 612 of the tissue portion. Thus, it is preferably if the remote unit 600 is primarily configured to prevent the first portion 641” from travelling through the hole in the tissue portion 612 towards the second side 618 of the tissue portion 610.
The first portion 641 ’ may further comprise one or several connections 605 for transferring energy and/or communication signals to the second portion 641” via the connecting portion 642. The connections 605 in the illustrated embodiment are symmetrically arranged around a circumference of a protrusion 607 of the first portion 641 ’ and are arranged to engage with a corresponding connection 609 arranged at an inner surface of the connecting portion 642. The protrusion 607 may extend in a central extension Cl of the central portion 642. The second portion 641” may also comprise one or several connections 611, which may be similarly arranged and configured as the connections 605 of the first portion 641’. For example, the one or several connections 611 may engage with the connection 609 of the connecting portion 642 to receive energy and/or communication signals from the first portion 641’. Although the protrusion 607 is illustrated separately in Figs. 26a and 26b, it is to be understood that the protrusion 607 may be formed as one integral unit with the first portion 641’.
Other arrangements of connections are envisioned, such as asymmetrically arranged connections around the circumference of the protrusion 607. It is also envisioned that one or several connections may be arranged on the first surface 614 of the first portion 641’, wherein the connections are arranged to engage with corresponding connections arranged on the opposing surface 613 of the connecting portion. Such connections on the opposing surface 613 may cover a relatively large area as compared to the connection 609, thus allowing a larger area of contact and a higher rate and/or signal strength of energy and/or communication signal transfer. Furthermore, it is envisioned that a physical connection between the first portion 641’, connecting portion 642 and second portion 641” may be replaced or accompanied by a wireless arrangement, as described further in other parts of the present disclosure. Any of the first surface 614 of the first portion 641’, the second surface 620 of the second portion 641’, the third surface 624 of the connecting portion 642, and an opposing surface 613 of the connecting portion 642, may be provided with at least one of ribs, barbs, hooks, a friction enhancing surface treatment, and a friction enhancing material, to facilitate the remote unit 600 being held in position by the tissue portion, and/or to facilitate that the different parts of the device are held in mutual position.
The opposing surface 613 of the connecting portion 642 and the first surface 614 of the first portion 641 ’ may provide, fully or partly, a connection mechanism to detachably connect the first portion 641’ to the connecting portion 642.
The opposing surface 613 may be provided with a recess configured to house at least part of the first portion 641 ’ . In particular, such recess may be configured to receive at least a portion of the first portion 641’, including the first surface 614. Similarly, the first surface 614 may be provided with a recess configured to house at least part of the connecting portion 642. In particular, such recess may be configured to receive at least a portion of the connecting portion 642, and in some embodiments such recess may be configured to receive at least one protruding element to at least partially enclose at least one protruding element or flange.
In the illustrated embodiment, the first portion 641’ comprises a first energy storage unit 304a and a controller 300a comprising one or several processing units connected to the first energy storage unit 304a. The first energy storage unit 304a may be rechargeable by wireless transfer of energy. In some embodiments, the first energy storage unit 304a may be non-rechargeable. Upon reaching the life-time end of such first energy storage, a replacement first portion comprising a new first energy storage unit may simply be swapped in place for the first portion having the depleted first energy storage unit. The second portion 641” may further comprise a controller 300b comprising one or several processing units.
As will be described in other parts of the present disclosure, the first portion 641 ’ and the second portion 641” may comprise one or several functional parts, such as receivers, transmitters, transceivers, control units, processing units, sensors, energy storage units, sensors, etc.
The remote unite 600 may be non-inflatable.
In figs 26a and 27, the second portion 641 ” in the illustrated embodiment comprises a pump 604, the specific embodiment of which is disclosed with reference to fig. 49h. However, it is to be understood that other embodiments of the second portion 641” are able to be connected to the first portion 641 ’ via the connecting portion 642, such as second portions 641” comprising a motor for providing mechanical work without the use of fluids or any of the other pumps described with reference to figs. 46a - 50. Furthermore, although the connecting portion 642 is illustrated in Fig. 26a as a separate unit, the connecting portion 642 may form part of the second portion 641” such that the portions forms part of a single unit. The first portion 641 ’ may be detachably connected to at least one of the connecting portion 642 and the second portion 641”.
Fig. 26b shows an embodiment similar to that of the embodiment of fig. 26a, the only difference being that the first and second connection 650a, 650b comprising hydraulic conduits are connected to the hydraulic pump 604 such that hydraulic fluid can be conducted to a first and second receiver of hydraulic fluid (e.g. for hydraulically operating a first and second hydraulic member / hydraulic cuff for exerting pressure on a blood vessel). The outflow from the hydraulic pump to the conduits 650a, 650b is controlled by two valves 660a, 660b which are electrically actuated and controlled from the controller 300 of the remote unit 600.
As can be seen in Fig. 27, the first, second, third and fourth planes PL1, PL2, PL3 and PL4, are parallel to each other. Furthermore, in the illustrated embodiment, the third cross-sectional area A3 is smaller than the first, second and fourth cross-sectional areas Al, A2 and A4, such that the first portion 641’, second portion 641” and connecting portion 642 are prevented from travelling through the hole in the tissue portion 610 in a direction perpendicular to the first, second and third planes PL1, PL2 and PL3. Hereby, the second portion 641” and the connecting portion 642 can be held in position by the tissue portion 610 of the patient also when the first portion 641 ’ is disconnected from the connecting portion 642.
It is to be understood that the illustrated planes PL1, PL2, PL3 and PL4 are merely an example of how such planes may intersect the remote unit 600. Other arrangements of planes are possible, as long as the conditions above are fulfilled, i.e. that the portions have cross-sectional areas, wherein the third cross-sectional area in the third plane PL3 is smaller than the first, second and fourth cross-sectional areas, and that the planes PL1, PL2, PL3 and PL4 are parallel to each other.
The connecting portion 642 illustrated in Fig. 26a may be defined as a connecting portion 642 comprising a flange 626. The flange 626 thus comprises the fourth cross-sectional area A4 such that the flange 626 is prevented from travelling through the hole in the tissue portion 610 in a direction perpendicular to the first, second and third planes PL1, PL2 and PL3. The flange 626 may protrude in a direction parallel to the first, second, third and fourth planes PL1, PL2, PL3 and PL4. This direction is perpendicular to a central extension Cl of the connecting portion 642.
The connecting portion 642 is not restricted to flanges, however. Other protruding elements may additionally or alternatively be incorporated into the connecting portion 642. As such, the connecting portion 642 may comprise at least one protruding element comprising the fourth cross- sectional area A4, such that the at least one protruding element is prevented from travelling through the hole in the tissue portion 610, such that the second portion 641” and the connecting portion 642 can be held in position by the tissue portion 610 of the patient also when the first portion 641’ is disconnected from the connecting portion 642. The at least one protruding element may protrude in a direction parallel to the first, second, third and fourth planes PL1, PL2, PL3 and PL4. This direction is perpendicular to a central extension Cl of the connecting portion 642. As such, the at least one protruding element will also comprise the third surface configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.
The connecting portion 642 may comprise a hollow portion 628. The hollow portion 628 may provide a passage between the first and second portions 641’, 641”. In particular, the hollow portion 628 may house a conduit for transferring fluid from the first portion 641’ to the second portion 641”. The hollow portion 628 may also comprise or house one or several connections or electrical leads for transferring energy and/or communication signals between the first portion 641 ’ and the second portion 641”.
Some relative dimensions of the remote unit 600 will now be described with reference to Figs. 27 and 28A - 28D, however it is to be understood that these dimensions may also apply to other embodiments of the remote unit 600. The at least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane being less than a height Hl of the first portion 641’ in said direction. The height HF may alternatively be less than half of said height Hl of the first portion 641’ in said direction, less than a quarter of said height Hl of the first portion 641 ’ in said direction, or less than a tenth of said height Hl of the first portion 641 ’ in said direction.
The height Hl of the first portion 641 ’ in a direction perpendicular to the first plane may be less than a height H2 of the second portion 641” in said direction, such as less than half of said height H2 of the second portion 641 ”in said direction, less than a quarter of said height H2 of the second portion 641 ”in said direction, or less than a tenth of said height H2 of the second portion 641” in said direction.
The at least one protruding element 626 may have a diameter DF in the fourth plane being one of less than a diameter DI of the first portion 641’ in the first plane, equal to a diameter DI of the first portion 641 ’ in the first plane, and larger than a diameter D 1 of the first portion 641 ’ in the first plane. Similarly, the cross-sectional area of the at least one protruding element 626 in the fourth plane may be less, equal to, or larger than a cross-sectional area of the first portion in the first plane.
The at least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane being less than a height HC of the connecting portion 642 in said direction. Here, the height HC of the connecting portion 642 is defined as the height excluding the at least one protruding element, which forms part of the connecting portion 642. The height HF may alternatively be less than half of said height HC of the connecting portion 642 in said direction, less than a quarter of said height HC of the connecting portion 642 in said direction, or less than a tenth of said height HC of connecting portion 642 in said direction.
It is important to note that although the implantable energized medical device is disclosed herein as having a third cross-sectional area being smaller than a first cross-sectional area, this feature is not essential. The third cross-sectional area may be equal to or larger than the first cross- sectional area.
As shown in Fig. 28D, the first portion 141’ may have a first cross-sectional area Al being equal to or smaller than the third cross-sectional area A3 of the connecting portion 142. In particular, the first portion 141’ does not necessarily need to provide a cross-sectional area being larger than the third cross-sectional area of connecting portion 142, intended to pass through a hole in the tissue, if the connecting portion 142 provides an additional cross-sectional area being larger than the third cross-sectional area of the connecting portion 142. The first portion 141’ as illustrated in Fig. 28D may comprise the components discussed elsewhere in the present disclosure, although not shown, such as an energy storage unit, receiver, transmitter, etc.
Wireless energy receivers and/or communication receivers and/or transmitters in the first portion 141’ may be configured to receive energy from and/or communicate wirelessly with an external device outside the body using electromagnetic waves at a frequency below 100 kHz, or more specifically below 40 kHz, or more specifically below 20 kHz. The wireless energy receivers and/or communication receivers and/or transmitters in the first portion 141’ may thus be configured to communicate with the external device using “Very Low Frequency” communication (VLF). VLF signals have the ability to penetrate a titanium housing of the implantable energized medical device, such that the electronics of the implantable medical device can be completely encapsulated in a titanium housing. In addition, or alternatively, communication and energy transfer between the first portion 141’ and second portion 141” may be made using VLF signals. In such embodiments, receivers and transmitters (for energy and/or communication) of the first portion 141’ and second portion 141” are configured accordingly.
As shown in Figs. 29A - 29B, the at least one protruding element 626 may have an annular shape, such as a disk shape. However, elliptical, elongated and/or other polyhedral or irregular shapes are also possible. In the illustrated embodiment, the at least one protruding element 626 extends a full revolution around the center axis of the connecting portion 642. However, other arrangements are possible, wherein the at least one protruding element 626 constitute a partial circle sector. In the case of a plurality of protruding elements, such plurality of protruding elements may constitute several partial circle sectors.
As shown in Figs. 30A - 30B, 31A - 3 IB, the connecting portion 642 may comprise at least two protruding elements 626, 627. For example, the connecting portion 642 may comprise at least three, four, five, fix, seven, eight, nine, ten protruding elements, and so on. In such embodiments, the at least two protruding elements 626, 627 may together comprise the fourth cross-sectional area, thus providing a necessary cross-sectional area to prevent the first portion and second portion from travelling through the hole in the tissue portion.
The at least two protruding elements 626, 627 may be symmetrically arranged about the central axis of the connecting portion, as shown in Figs. 30a - 30b, or asymmetrically arranged about the central axis of the connecting portion, as shown in Figs. 3 la - 3 lb. In particular, the at least two protruding elements 626, 627 may be asymmetrically arranged so as to be located towards one side of the connecting portion 642, as shown in Figs. 3 la - 3 lb. The arrangement of protruding element(s) may allow the remote unit 600, and in particular the connecting portion 642, to be placed in areas of the patient where space is limited in one or more directions.
The first portion 641 ’ may comprise a first energy storage unit for supplying the remote unit 600 with energy.
Although one type or embodiment of the implantable remote unit 600, may fit most patients, it may be necessary to provide a selection of implantable remote units 600 or portions to be assembled into implantable remote units 600. For example, some patients may require different lengths, shapes, sizes, widths or heights depending on individual anatomy. Furthermore, some parts or portions of the implantable remote units 600 may be common among several different types or embodiments of remote units, while other parts or portions may be replaceable or interchangeable. Such parts or portions may include energy storage devices, communication devices, fluid connections, mechanical connections, electrical connections, and so on.
To provide flexibility and increase user friendliness, a kit of parts may be provided. The kit preferably comprises a group of one or more first portions, a group of one or more second portions, and a group of one or more connecting portions, the first portions, second portions and connecting portions being embodied as described throughout the present disclosure. At least one of the groups comprises at least two different types of said respective portions. By the term “type”, it is hereby meant a variety, class or embodiment of said respective portion.
In some embodiments of the kit, the group of one or more first portions, the group of one or more second portions, and the group of one or more connecting portions, comprise separate parts which may be assembled into a complete remote unit. The remote unit may thus be said to be modular, in that the first portion, the second portion, and/or the connecting portion may be interchanged for another type of the respective portion.
In some embodiments, the connecting portion form part of the first portion or the second portion.
With reference to Fig. 32, the kit for assembling the remote unit comprises a first portion 641 ’, a group of three connecting portions 642a, 642b, 642c, and a group of two second portions 641”a,641”b. For simplicity, all types and combinations of first portions, second portions and connecting portions will not be illustrated or described in detail.
Accordingly, the group of connecting portions 642a, 642b, 642c comprise three different types of connecting portions. Here, the different types of connecting portions comprise connecting portions 642a, 642b, 642c having different heights. Furthermore, the group of two different types of second portions 641 ”a,641 ”b are configured to eccentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the second end of the second portion 641 ”a comprises or is configured for at least one connection for connecting to an implant being located in a caudal direction from a location of the remote unit 600 in the patient, when the device is assembled. In the illustrated figure, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including the second end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Furthermore, the different types of second portions 641” comprise a second portion 641’ ’b being configured to eccentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the first end of the second portion 641”b comprises or is configured for at least one connection for connecting to an implantable medical device for stretching the stomach wall of the patient, being located in a cranial direction from a location of the remote unit in the patient, when the device is assembled. In the illustrated figure, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including the first end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Thus, the remote unit may be modular, and different types of devices can be achieved by selecting and combining a first portion 641’, a connecting portion 642, and a second portion 641”, from each of the groups.
In the illustrated example, a first remote unit 600a is achieved by a selection of the first portion 641’, the connecting portion 642a, and the second portion 641”a. Such remote unit 600a may be particularly advantageous in that the connecting portion 642a may be able to extend through a thick layer of tissue to connect the first portion 641 ’ and the second portion 641 ”a. Another remote unit 600b is achieved by a selection of the first portion 641’, the connecting portion 642c, and the second portion 641”b. Such device may be particularly advantageous in that the connecting portion 642c has a smaller footprint than the connecting portion 642a, i.e. occupying less space in the patient. Owing to the modular property of the remote units 600a and 600b, a practician or surgeon may select a suitable connecting portion as needed upon having assessed the anatomy of a patient. Furthermore, since remote units 600a and 600b share a common type of first portions 641’, it will not be necessary for a practician or surgeon to maintain a stock of different first portions (or a stock of complete, assembled devices) merely for the sake of achieving a device having different connections located in the first end or second end of the second portion respectively, as in the case of second portions 641”a, 641”b.
The example illustrated in Fig. 32 is merely exemplifying to display the idea of a modular implantable remote unit 600. The group of one or more first portions 641 ’ may comprise a variety of different features, such as first portions with or without a first energy storage unit, with or without a first wireless energy receiver unit for receiving energy transmitted wirelessly by an external wireless energy transmitter, with or without an internal wireless energy transmitter, and/or other features as described throughout the present disclosure. Other features include different height, width, or length of the first portion. It is to be understood that first portions having one or more such features may be combined with a particular shape or dimensions to achieve a variety of first portions. The same applies to connecting portions and second portions.
With reference to Fig. 41, an embodiment of an implantable remote unit 600, will be described. The remote unit 600 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 600 comprises a first portion 641 ’ configured to be placed on a first side of the tissue portion 610, the first portion 641’ having a first cross-sectional area in a first plane and comprising a first surface configured to face and/or engage a first tissue surface of the first side of the tissue portion 610. The remote unit 600 further comprises a second portion 641” configured to be placed on a second side of the tissue portion 610, the second side opposing the first side, the second portion 641” having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion 610. The remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides of the tissue portion 610. The connecting portion 642 here has a third cross-sectional area in a third plane. The connecting portion 642 is configured to connect the first portion 641 ’ to the second portion 641”. Here, the first portion 641’ comprises a first wireless energy receiver 308a for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter 308a configured to transmit energy wirelessly to the second portion. Furthermore, the second portion here comprises a second wireless energy receiver 308b configured to receive energy transmitted wirelessly by the internal wireless energy transmitter 308a.
Although receivers and transmitters may be discussed and illustrated separately in the present disclosure, it is to be understood that the receivers and/or transmitters may be comprised in a transceiver. Furthermore, the receivers and/or transmitters in the first portion 641 ’ and second portion 641” respectively may form part of a single receiving or transmitting unit configured for receiving or transmitting energy and/or communication signals, including data. Furthermore, the internal wireless energy transmitter and/or a first wireless communication receiver/transmitter may be a separate unit 308c located in a lower portion of the first portion 641’, referred to as a proximal end of the first portion 641 ’ in other parts of the present disclosure, close to the connecting portion 642 and the second portion 641”. Such placement may provide for that energy and/or communication signals transmitted by the unit 308c will not be attenuated by internal components of the first portion 641 ’ when being transmitted to the second portion 641”. Such internal components may include a first energy storage unit 304a.
The first portion 641’ here comprises a first energy storage unit 304a connected to the first wireless energy receiver 308a. The second portion comprises a second energy storage unit 304b connected to the second wireless energy receiver 308b. Such an energy storage unit may be a solid- state battery, such as a thionyl-chloride battery.
In some embodiments, the first wireless energy receiver 308a is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the internal wireless energy transmitter 308a is configured to wirelessly transmit energy stored in the first energy storage unit 304a to the second wireless energy receiver 308b, and the second wireless energy receiver 308b is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter 308a and store the received energy in the second energy storage unit 304b.
The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b. Hereby, charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow. Thus, a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first wireless energy transmitter 308a, c and the second wireless energy receiver 308b.
The first portion may comprise a first controller comprising at least one processing unit 306a. The second portion may comprise a second controller comprising at least one processing unit 306b. At least one of the first and second processing unit 306a, 306b may be connected to a wireless transceiver 308a, b,c for communicating wirelessly with an external device.
The first controller may be connected to a first wireless communication receiver 308a, c in the first portion 641’ for receiving wireless communication from an external device and/or from a wireless communication transmitter 308b in the second portion 641”. Furthermore, the first controller may be connected to a first wireless communication transmitter 308a, c in the first portion 641’ for transmitting wireless communication to a second wireless communication receiver 308b in the second portion 641”. The second controller may be connected to the second wireless communication receiver 308b for receiving wireless communication from the first portion 1
641’. The second controller may further be connected to a second wireless communication transmitter 308b for transmitting wireless communication to the first portion 641’.
In some embodiments, the first wireless energy receiver 308a comprises a first coil, and the wireless energy transmitter 308a, c comprises a second coil, as shown in Fig. 44.
The device may further comprise at least one sensor (not shown) for providing input to at least one of the first and second controller 300a, 300b. Such sensor data may be transmitted to an external device via the first wireless communication transmitter 308a and/or the second wireless communication transmitter 308b. The sensor may be or comprise a sensor configured to sense a physical parameter of the implantable system, including the vessel member, such as a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of at least one of the first and second energy storage units 304a, 304b, and a parameter related to a wireless transfer of energy from a source external to the body of the patient. The sensor configured to sense a parameter related to strain in the implantable system could be configured to sense a strain in the adjustable vessel member connected to the expansion of the aneurysm. In hydraulic embodiments, the sensor could be a sensor measuring the strain in the implantable system by measuring the volume or pressure in a hydraulic cuff or in a conduit or fluid reservoir connected to the hydraulic cuff. In the alternative, the sensor could be a sensor configured to measure strain in the implantable system by measuring elongation of an element in connection with the blood vessel. The sensor may be comprised in the inner surface of the adjustable vessel member, such as in the portion of the hydraulic cuff in connection with the blood vessel.
The sensor could in alternative embodiment be configured to sense at least one physiological parameter of the patient. The physiological parameter of the patient could be related to the blood pressure of the patient, the size of the aneurysm, the expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker. The physiological parameter may also comprise a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
The sensor may be configured to sense a temperature of the implantable system to avoid excessive heating of tissue connected to the implantable system during operation, or during charging of an energy storage unit in the implantable system. Excessive heating may also damage the implantable system and/or the energy storage unit. Excessive heating may also be an indicator that something is wrong with the implantable system and may be used for triggering an alarm function for alerting the patient or physician. The sensor may also be configured to sense a parameter related to the power consumption of the implantable system, to avoid excessive power consumption which may drain and/or damage the energy storage unit. Excessive power consumption may also be an indicator that something is wrong with the implantable system and may be used for triggering an alarm function for alerting the patient or physician.
With reference to Figs. 34, 37A and 37B, an embodiment of an implantable remote unit 600 will be described. The remote unit 600 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 600 comprises a first portion 641’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641’ having a first cross-sectional area Al in a first plane PL1 and comprising a first surface 614 configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area A2 in a second plane PL2 and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 642 here has a third cross-sectional area A3 in a third plane PL3. The connecting portion 642 is configured to connect the first portion 641 ’ to the second portion 641”. In the illustrated embodiment, a connecting interface 630 between the connecting portion 642 and the second portion 641 ” is eccentric with respect to the second portion 641”.
The first portion 641’ has an elongated shape in the illustrated embodiment of Fig. 34. Similarly, the second portion 641” has an elongated shape. However, the first portion 641’ and/or second portion 641” may assume other shapes, such as a flat disk e.g. having a width and length being larger than the height, a sphere, an ellipsoid, or any other polyhedral or irregular shape, some of these being exemplified in Figs. 34 - 36.
As illustrated in figs. 37A and 37B, the connecting interface 630 between the connecting portion 642 and the second portion 641” may be eccentric, with respect to the second portion 641” in a first direction 631, but not in a second direction 633 being perpendicular to the first direction. The first direction 631 is here parallel to the line A-A, to the second plane PL2, and to a length of the second portion 641”. The second direction 633 is here parallel to the line B-B, to the second plane PL2, and to a width of the second portion 641 ”. It is also possible that the connecting interface between the connecting portion 642 and the second portion 641 ” is eccentric, with respect to the second portion 641 ”, in the first direction 631 as well as in the second direction 633 being perpendicular to the first direction 631.
Similarly, a connecting interface between the connecting portion 642 and the first portion 641 ’ may be eccentric with respect to the first portion 641’ in the first direction 631 , and/or in the second direction 633.
The first portion 641’, connecting portion 642 and second portion 641” may structurally form one integral unit. It is however also possible that the first portion 641 ’ and the connecting portion 642 structurally form one integral unit, while the second portion 641” form a separate unit, or, that the second portion 641” and the connecting portion 642 structurally form one integral unit, while the first portion 641 ’ form a separate unit.
Additionally, or alternatively, the second portion 641” may comprise a removable and/or interchangeable portion 639. In some embodiments, the removable portion 639 may form part of a distal region which will be further described in other parts of the present disclosure. A removable portion may also form part of a proximal region. Thus, the second portion 641” may comprise at least two removable portions, each being arranged at a respective end of the second portion 641”. The removable portion 639 may house, hold or comprise one or several functional parts of the remote unit 600, such as gears, motors, connections, reservoirs, and the like as described in other parts of the present disclosure. An embodiment having such removable portion 639 will be able to be modified as necessary to circumstances of a particular patient.
In the case of the first portion 641’, connecting portion 642 and second portion 641” structurally forming one integral unit, the eccentric connecting interface between the connecting portion 642 and the second portion 641”, with respect to the second portion 641”, will provide for that the remote unit 600 will be able to be inserted into the hole in the tissue portion. The remote unit 600 may for example be inserted into the hole at an angle, similar to how a foot is inserted into a shoe, to allow most or all of the second portion 641 ” to pass through the hole, before it is angled, rotated, and/or pivoted to allow any remaining portion of the second portion 641 ” to pass through the hole and allow the remote unit 600 to assume its intended position.
As illustrated in figs. 34 - 36, the first portion 641’ may assume a variety of shapes, such as an oblong shape, a flat disk shape, a spherical shape, or any other polyhedral or irregular shape. Similarly, the second portion 641” may assume a variety of shapes, such as an oblong shape, a flat disk shape, a spherical shape, or any other polyhedral or irregular shape. The proposed shapes of the first and second portions 641’, 641” may be mixed and combined to form embodiments not exemplified in the illustrated embodiments. For example, one or both of the first and second portions 641’, 641” may have a flat oblong shape. In this context, the term “flat” is related to the height of the first or second portion 641’, 641”, i.e. in a direction parallel to a central extension Cl of the connecting portion 642. The term “oblong” is related to a length of the first or second portion 641’, 641”. A definition of such length is further discussed in other parts of the present disclosure.
With reference to Figs. 37A - 37B, the second portion 641” has a first end 632 and a second end 634 opposing the first end 632. The length of the second portion 641” is defined as the length between the first end 632 and the second end 634. The length of the second portion 641” is furthermore extending in a direction being different to the central extension C 1 of the connecting portion 642. The first end 632 and second end 634 are separated in a direction parallel to the second plane PL2. Similarly, the first portion 641’ has a length between a first and a second end, the length extending in a direction being different to the central extension C 1 of the connecting portion 642.
The second portion 641” may be curved along its length. For example, one or both ends of the second portion 641” may point in a direction being substantially different from the second plane PL2, i.e. curving away from or towards the tissue portion when implanted. In some embodiments, the second portion 641” curves within the second plane PL2, exclusively or in combination with curving in other planes. The second portion 641” may also be curved in more than one direction, i.e. along its length and along its width, the width extending in a direction perpendicular to the length. The first and second ends 632, 634 of the second portion 641” may comprise an elliptical point respectively. For example, the first and second ends 632, 634 may comprise a hemispherical end cap respectively. It is to be understood that also the first and second ends of the first portion 641’ may have such features.
The second portion 641” may have at least one circular cross-section along the length between the first end 632 and second end 634, as illustrated in fig. 34. It is however possible for the second portion 641 ” to have at least one oval cross-section or at least one elliptical cross-section along the length between the first end 632 and the second end 634. Such cross-sectional shapes may also exist between ends in a width direction of the second portion 641”. Similarly, such cross- sectional shapes may also exist between ends in a length and/or width direction in the first portion 641’.
In the following paragraphs, some features and properties of the second portion 641” will be described. It is however to be understood that these features and properties may also apply to the first portion 641’.
The second portion 641” has a proximal region 636, an intermediate region 638, and a distal region 640. The proximal region 636 extends from the first end 632 to an interface between the connecting portion 642 and the second portion 641”, the intermediate region 638 is defined by the connecting interface 630 between the connecting portion 642 and the second portion 641”, and the distal region 640 extends from the connecting interface 630 between the connecting portion 642 and the second portion 641 ” to the second end 634. The proximal region 636 is shorter than the distal region 640 with respect to the length of the second portion, i.e. with respect to the length direction 631. Thus, a heel (the proximal region) and a toe (the distal region) is present in the second portion 641”.
The second surface 620, configured to engage with the second tissue surface 622 of the second side 618 of the tissue portion 610, is part of the proximal region 636 and the distal region 640. If a length of the second portion 641 ” is defined as x, and the width of the second portion 641” is defined as y along respective length and width directions 631, 633 being perpendicular to each other and substantially parallel to the second plane PL2, the connecting interface between the connecting portion 642 and the second portion 641 ” is contained within a region extending from x>0 to x<x/2 and/or y>0 to <y/2, x and y and 0 being respective end points of the second portion 641” along said length and width directions. In other words, the connecting interface between the connecting portion 642 and the second portion 641 ” is eccentric in at least one direction with respect to the second portion 641 ”, such that a heel and a toe is formed in the second portion 641”.
The first surface 614 configured to face and/or engage the first tissue surface 616 of the first side 612 of the tissue portion 610 may be substantially flat. In other words, the first portion 641’ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion 641’, facing away from the tissue portion 610, may be substantially flat. Similarly, the second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 may be substantially flat. In other words, the second portion 641” may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion 641”, facing away from the tissue portion 610, may be substantially flat.
The second portion 641” may be tapered from the first end 632 to the second end 634, thus giving the second portion 641” different heights and/or widths along the length of the second portion 641”. The second portion may also be tapered from each of the first end 632 and second end 634 towards the intermediate region 638 of the second portion 641”.
Some dimensions of the first portion 641’, the second portion 641” and the connecting portion 642 will now be disclosed. Any of the following disclosures of numerical intervals may include or exclude the end points of said intervals.
The first portion 641’ may have a maximum dimension being in the range of 10 to 60 mm, such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the range of 10 to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such as in the range of 15 to 30 mm, such as in the range of 15 to 25 mm. By the term “maximum dimension” it is hereby meant the largest dimension in any direction.
The first portion 641’ may have a diameter being in the range of 10 to 60 mm, such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the range of 10 to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such as in the range of 15 to 30 mm, such as in the range of 15 to 25 mm.
The connecting portion 642 may have a maximum dimension in the third plane PL3 in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, such as in the range of 2 to 10 mm, such as in the range of 5 to 10 mm, such as in the range of 8 to 20 mm, such as in the range of 8 to 15 mm, such as in the range of 8 to 10 mm.
The second portion 641” may have a maximum dimension being in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, such as in the range of 30 to 60 mm, such as in the range of 30 to 40 mm, such as in the range of 35 to 90 mm, such as in the range of 35 to 70 mm, such as in the range of 35 to 60 mm, such as in the range of 35 to 40 mm.
The first portion has a first height Hl, and the second portion has a second height H2, both heights being in a direction perpendicular to the first and second planes PL1, PL2. The first height may be smaller than the second height. However, in the embodiments illustrated in Figs. 37A-37B, the first height Hl is substantially equal to the second height H2. Other height ratios are possible, for example the first height Hl may be less than 2/3 of the second height H2, such as less than 1/2 of the second height H2, such as less than 1/3 of the second height H2, such as less than 1/4 of the second height H2, such as less than 1/5 of the second height H2, such as less than 1/10 of the second height H2. As illustrated in Figs. 37A-37B, the proximal region 636 has a length 642 being shorter than a length 646 of the distal region 640. The intermediate region 638 has a length 644, and a width 648. In some embodiments, the length 644 of the intermediate region 638 is longer than the width 648. In other words, the connecting interface between the connecting portion 642 and the second portion 641” may be elongated, having a longer dimension (in the exemplified case, the length) and a shorter dimension (in the exemplified case, the width). It is also possible that the length 644 of the intermediate region 638 is shorter than the width 648 of the intermediate region 638.
The length 646 of the distal region 640 is preferably longer than the length 644 of the intermediate region 638, however, an equally long distal region 640 and intermediate region 638, or a shorter distal region 640 than the intermediate region 638, is also possible. The length 642 of the proximal region 636 may be shorter than, equal to, or longer than the length 644 of the intermediate region 638.
The length 644 of the intermediate region 638 is preferably less than half of the length of the second portion 641”, i.e. less than half of the combined length of the proximal region 636, the intermediate region 638, and the distal region 630. In some embodiments, the length 644 of the intermediate region 638 is less than a third of the length of the second portion 641”, such as less than a fourth, less than a fifth, or less than a tenth of the length of the second portion 641”.
The connecting portion may have one of an oval cross-section, an elongated cross-section, and a circular cross-section, in a plane parallel to the third plane PL3. In particular, the connecting portion may have several different cross-sectional shapes along its length in the central extension Cl.
Figs. 37C - 37D illustrate an embodiment similar to the one described in conjunction with Figs. 37A - 37B. However, the embodiment of Figs. 37C - 37D lacks a proximal portion, i.e. the second portion 641” does not comprise a “heel”. Furthermore, such embodiment may have a connecting portion 642 having a length and width, in directions 631 and 633 respectively, being equal to a height of the second portion in a direction parallel to the central extension Cl, as illustrated. Thus, the connectiioOng portion 642 and the second portion 641” may be constituted by a substantially uniformly wide body.
In some embodiments the distal region 640 is configured to be directed downwards in a standing patient, i.e. in a caudal direction when the remote unit 600 is implanted.
As illustrated in Figs. 38A - 38D, different orientations of the second portion 641” relative the first portion 641 ’ are possible. In some embodiments, a connection between either the first portion 641 ’ and the connecting portion 642, or between the second portion 641” and the connecting portion 642, may allow for a plurality of different connecting orientations. For example, a connection mechanism between the first portion 641 ’ and the connecting portion 642 (or between the second portion 641” and the connecting portion 642) may possess a 90-degree rotational symmetry to allow the second portion 641’ to be set in four different positions with respect to the first portion 641, each differing from the other by 90 degrees. Other degrees of rotational symmetry are of course possible, such as 30 degrees, 45 degrees, 60 degrees, 120 degrees, 180 degrees and so on. In other embodiments there are no connective mechanism between any of the first portion 641’, the connecting portion 642, and the second portion 641” (i.e. the portions are made as one integral unit), and in such cases different variants of the remote unit 600 can be achieved during manufacturing. In other embodiments, the connective mechanism between the first portion 641’ and the connecting portion 642 (or between the second portion 641” and the connecting portion 642) is non-reversible, i.e. the first portion 641’ and the second portion 641” may initially be handled as separate parts, but the orientation of the second portion 641” relative the first portion 641 ’ cannot be changed once it has been selected and the parts have been connected via the connecting portion 642.
The different orientations of the second portion 641” relative the first portion 641 ’ may be defined as the length direction of the second portion 641” having a relation or angle with respect to a length direction of the first portion 641’. Such angle may be 15 degrees, 30, 45, 60, 75 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270, 285, 300, 315, 330, 345 or 360 degrees. In particular, the angle between the first portion 641 ’ and the second portion 641” may be defined as an angle in the planes PL1 and PL2, or as an angle in a plane parallel to the tissue portion 610, when the remote unit 600 is implanted. In the embodiment illustrated in Figs. 38A - 38D, the length direction of the second portion 641 ” is angled by 0, 90, 180, and 270 degrees with respect to the length direction of the first portion 641’.
Referring now to Figs. 38e-k, 38m, 38n, 38p and 38q. The following will discuss some features of the first portion 141’, and in some cases additionally or alternatively of the connecting portion 142, which enable the first portion 141’ to increase its cross-sectional area in the first plane (i.e. to increase an area of the first surface configured to face the first tissue surface), and/or which enable the first portion 141’ to be rotated, translated, or otherwise moved in relation to the connecting portion 142. In some embodiments, the first portion 141’ will be configured to extend further away from the connecting portion 142 in or within the first plane. It is to be understood that these features can be combined with other features of the implantable energized medical device. In particular, the specific shape of the first portion, connecting portion and/or second portion in the illustrated embodiments are merely exemplary. Other shapes are possible, as discussed in the present disclosure. Accordingly, the elongated second portion 141” does not necessarily need to be elongated as shown for example in Fig. 38e, and furthermore, the first portion 141’ does not necessarily need to have a semicircular shape.
With reference to Fig. 38e, an implantable energized medical device 140 is shown, wherein the first portion 141’ is configured and shaped such that an edge 710 of the first portion 141’ is substantially aligned with the connecting portion 142 with regard to the first direction 631. In other words, no part of the first portion 141’ protrudes forward of the connecting portion 142 with regard to the first direction 631. Hereby, insertion of the implantable energized medical device 140 may be facilitated, in particular when angled downwards, since the first portion 141 ’ will not abut the tissue until most or all of the second portion 141” has been inserted through the hole in the tissue. Although the edge 710, as well as other edges of the first portion 141’, are hereby shown as having no radius, radiused edges are possible. Thus, the edge 710 may have a radius, and/or the first portion 141’, and/or the second portion 141”, and/or the connecting portion 142, may comprise radiused edges.
With reference to Figs. 38f and 38g, a first portion 141’ is shown being configured to have its surface area increased. Here, the first cross-sectional area is increased, thereby increasing an area of the first surface configured to face (and in some embodiments also configured to contact) the first tissue surface. In the illustrated embodiment, the first portion 141’ comprises a first element 712 and a second element 714 being hingedly interconnected to allow the first element 712 to assume a first state (not shown) wherein the first element 712 is arranged on top of the second element 714, and a second state wherein the first element 712 is folded to be located adjacent or next to the second element 714. A similar configuration may be achieved by other means of interconnection between the first element 712 and second element 714, i.e. the configuration is not limited to a hinge-type connection. For example, the first element 712 and second element 714 may be constructed of a single piece of material being flexible enough to be able to fold over itself to assume the first and second state respectively.
Preferably, the first and second element 712, 714 are interconnected and formed such that a transition between the first and second element 712, 714 along the first direction 631 is flush. Furthermore, while in the first state, the first portion 141’ may possess the same feature as discussed in conjunction with Fig. 38e, i.e. the first portion 141’ may be substantially aligned with the connecting portion 142.
With reference to Figs. 38h and 38i, a first portion 141’ is shown being configured to have its surface area increased. Here, the first cross-sectional area is increased, thereby increasing an area of the first surface configured to face (and in some embodiments also configured to contact) the first tissue surface. In the illustrated embodiment, the first portion 141’ comprises a first element 712 and a second element 714. The second element 714 here comprises a slot 715 configured to partially or fully house the first element 712. The first element 712 is configured to rotate about an axis to assume a first state, wherein the first element 712 is partially or completely housed in within the slot 715, and a second state wherein the first element 712 protrudes from the slot 715 to increase the first cross-sectional area. The first element 712 may be configured to rotate 180 degrees about the axis. In the illustrated example, the first and second elements 712, 714 are shaped as semi-circles and form a shape conforming to a full circle in the second state. However, it is also possible that the first element 712 only rotate about the axis up to 90 degrees, thus forming a shape conforming to three quarters of a circle in the second state. Other shapes are also possible, e.g. polygons.
With reference to Figs. 38j and 38k, a similar configuration as described with reference to Figs. 38h and 38i is shown. However, here the second element 714 does not comprise a slot, and the first element is thus not housed in a slot. Instead, the first element 712 is arranged on top of the second element 714 (similar to the embodiment of Figs. 38f and 38g). The first portion 141’ is here configured to have its surface area increased, in particular the first cross-sectional area is increased, thereby increasing an area of the first surface configured to face (and in some embodiments also configured to contact) the first tissue surface. The first element 712 is configured to rotate about an axis to assume a first state, wherein the first element 712 is partially or completely arranged on top of the second element 714. Here, “completely arranged on top of’ means that the first element 712 is confined within the borders of the second element 714. By rotation of the first element 712 about the axis, the first element 712 can assume a second state wherein the first element 712 protrudes over an edge or border of the second element 714 to increase the first cross-sectional area. The first element 712 may be configured to rotate 180 degrees about the axis. However, it is also possible that the first element 712 only rotate about the axis up to 90 degrees. Other shapes of the first and second element 712, 714 are also possible, e.g. polygons.
With reference to Figs. 38m and 38n, a first portion 141’ is shown being configured to have its surface area increased. Here, the first cross-sectional area is increased, thereby increasing an area of the first surface configured to face (and in some embodiments also configured to contact) the first tissue surface. In the illustrated embodiment, the first portion 141’ comprises a first element 712 and a second element 714. The first element 712 here comprises a slot configured to partially or completely house the second element 714. The first element 712 is configured to assume a first state, as shown in Fig. 38m, wherein the second element 714 is arranged partially or fully within the slot of the first element 712, and a second state, as shown in Fig. 38n, wherein the first element 712 has been moved in a first direction to cause the second element 714 to protrude from the slot of the first element 712, and to cause the first element 712 to extend further away from the connecting portion 142 in the first plane. As will be understood, other variations are possible, e.g. the second element 714 may comprise the slot, and the first element 712 may be partially or fully housed within such slot, and subsequently the first element 712 or the second element 714 may be moved to protrude from such slot.
With reference to Figs. 38p and 38q, a first portion 141’ is shown being configured to be moved in relation to the connecting portion 142. The expression “configured to be moved” may in this context be interpreted as the first portion 141’ being configured to assume at least two different positions with regard to the connecting portion 142 while still remaining in direct contact with the connecting portion. Here, the connecting portion 142 comprises a protruding element 717 and the first portion 141’ comprises a slot 718, wherein the protruding element 717 is configured to slide within the slot 718 along a predetermined path, e.g. in a first direction and a direction opposite said first direction. The protruding element 717 may be configured to be interlocked within the slot 718 such that the protruding element 717 can only be removed from the slot 718 in a preconfigured position. In other embodiments, the protruding element 717 may be permanently enclosed within the slot 718. By sliding the first portion 141’ in the first direction, an extension of the first portion 141 ’ in the first plane with respect to the connecting portion 142 will be able to be adjusted. Any position between the endpoints of the slot 718 may be able to be assumed by the first portion 141’. In particular, first portion 141’ and/or the connecting portion 142 may comprise a locking mechanism configured to secure a position of the first portion 141’ in relation to the connecting portion 142. Such locking mechanism may rely on flexible parts being biased towards each other to maintain the first portion 141’ and connecting portion 142 in a fixed position in relation to each other. Other possible locking mechanisms include the use of friction, snap-locking means, etc.
The second end 634 of the second portion 641” may comprise one or several connections for connecting to an implant being located in a caudal direction from a location of the remote unit 600 in the patient. Hereby, when the remote unit 600 is implanted in a patient, preferably with the distal region 640 and second end 634 pointing downwards in a standing patient, the connections will be closer to the implant as the second end 634 will be pointing in the caudal direction whereas the first end 632 will be pointing in the cranial direction. It is also possible that the second end 634 of the second portion 641” is configured for connecting to an implant, i.e. the second end 634 may comprise a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
Likewise, the first end 632 of the second portion 641” may comprise one or several connections for connecting to an implant being located in a cranial direction from a location of the remote unit in the patient. Hereby, when the remote unit 600 is implanted in a patient, preferably with the distal region 640 and second end 634 pointing downwards in a standing patient, the connections will be closer to the implant as the first end 632 will be pointing in the cranial direction whereas the second end 634 will be pointing in the caudal direction. It is also possible that the first end 632 of the second portion 641” is configured for connecting to an implant, i.e. the first end 632 may comprise a port, connector or other type of connective element for transmission of power, fluid, and/or signals.
With reference to figs. 39 and 40, an embodiment of an implantable remote unit 600 will be described. The remote unite 600 is configured to be held in position by a tissue portion 610 of a patient (such as for example further described with reference to fig. 17). The remote unit 600 comprises a first portion 641’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641 ’ having a first cross-sectional area in a first plane and comprising a first surface 614 configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 642 here has a third cross- sectional area in a third plane. The connecting portion 642 is configured to connect the first portion 641 ’ to the second portion 641”.
With reference to Fig. 41, the first cross-sectional area has a first cross-sectional distance CD la and a second cross-sectional distance CD2a, the first and second cross-sectional distances CD la, CD2a being perpendicular to each other and the first cross-sectional distance CD la being longer than the second cross-sectional distance CD2a. Furthermore, the second cross-sectional area has a first cross-sectional distance CD lb and a second cross-sectional distance CD2b, the first and second cross-sectional distances CD2a, CD2b being perpendicular to each other and the first cross- sectional distance CD lb being longer than the second cross-sectional distance CD2b. The first cross-sectional distance CD la of the first cross-sectional area and the first cross-sectional distance CD lb of the second cross-sectional area are rotationally displaced in relation to each other with an angle exceeding 45° to facilitate insertion of the second portion 641” through the hole in the tissue portion. In the embodiment illustrated in Fig. 41, the rotational displacement is 90°.
The rotational displacement of the first portion 641 ’ and the second portion 641” forms a cross-like structure, being particularly advantageous in that insertion through the hole in the tissue portion 610 may be facilitated, and once positioned in the hole in the tissue portion 610 a secure position may be achieved. In particular, if the remote unit 600 is positioned such that the second portion 641” has its first cross-sectional distance CD lb extending along a length extension of the hole 611 in the tissue portion 610, insertion of the second potion 641” through the hole 611 may be facilitated. Furthermore, if the first portion 641’ is then displaced in relation to the second portion 641” such that the first cross-sectional distance CD la of the first portion 641 ’ is displaced in relation to a length extension of the hole 611, the first portion 641 ’ may be prevented from travelling through the hole 611 in the tissue portion. In these cases, it is particularly advantageous if the hole 611 in the tissue portion is oblong, ellipsoidal, or at least has one dimension in one direction being longer than a dimension in another direction. Such oblong holes in a tissue portion may be formed for example in tissue having a fiber direction, where the longest dimension of the hole may be aligned with the fiber direction.
In the embodiment illustrated in Fig. 39, the first surface 614 of the first portion 641’ is flat, thus providing a larger contact surface to the first tissue surface 616 and consequently less pressure on the tissue portion. A more stable position may also be achieved by the flat surface. Also, the second surface 620 of the second portion 641” may be flat. However, other shapes, such as those described in other parts of the present disclosure, are possible.
As shown in Fig. 41, the connecting portion 642 may have an elongated cross-section in the third plane. It may be particularly advantageous if the connecting portion 642 has a longer length 644 than width 648, said length 644 extending in the same direction as a length direction of the second portion 641”, i.e. in the same direction as an elongation of the second portion 641”. Hereby, the elongation of the connecting portion 642 may run in the same direction as an elongation of the hole in the tissue portion.
With reference to Fig. 42, the rotational displacement of first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area is shown, here at an angle about 45°. Accordingly, there is a rotational displacement, in the first, second and third planes, between a length direction 633 of the first portion 641 ’ and a length direction 631 of the second portion 641”. Other angles of rotational displacement are possible, such as 60°, 75, 90°, 105°, 120°, 135°, etc.
One and the same remote unit 600 may be capable of assuming several different arrangements with regards to rotational displacement of the first portion 641 ’ and the second portion 641 ” . In particular, this is possible when the first portion 641 ’ and/or the second portion 641” is configured to detachably connect to the interconnecting portion 642. For example, a connection mechanism between the first portion 641 ’ and the connecting portion 642, or between the second portion 641” and the connecting portion 642, may possess a rotational symmetry to allow the first portion 641 ’ to be set in different positions in relation to the connecting portion 642 and in extension also in relation to the second portion 641”. Likewise, such rotational symmetry may allow the second portion 642” to be set in different positions in relation to the connecting portion 642 and in extension also in relation to the first portion 641’.
With reference to Figs. 43 A - 43C, a procedure of insertion of the remote unit 600 in a tissue portion 610 will be described. The remote unit 600 may be oriented such that a length direction 631 of the second portion 641” points downwards into the hole 611. Preferably, the second portion 641 ” is positioned such that it is inserted close to an edge of the hole 611. The second portion 641” may then be inserted partially through the hole 611, until the point where the first portion 641 ’ abuts the first tissue surface 616. Here, a 90° rotational displacement between the first portion 641’ and the second portion 641”, as described above, will allow a relatively large portion of the second portion 641 ” to be inserted before the first portion 641 ’ abuts the first tissue surface 616. Subsequently, the remote unit 600 may be pivoted to slide or insert the remaining portion of the second portion 641” through the hole 611. While inserting the remaining portion of the second portion 641”, the tissue may naturally flex and move to give way for the second portion 641”. Upon having fully inserted the second portion 641” through the hole 611, such that the second portion 641” is completely located on the other side of the tissue portion 610, the tissue may naturally flex back.
Figs. 43D - 43L shows embodiments of the remote unit 600. As illustrated, these implantable energized medical devices have a second portion 641” being shaped in a particular manner in order to facilitate removal of the remote unit 600 once it has been implanted for a period of time and fibrotic tissue has begun to form around the second portion 641’ ’. It is hereby disclosed that these types of second portions, as illustrated in Figs. 43D - 43L, and as disclosed below, may be combined with any of the other features of the remote units 600 in the present disclosure.
The remote unit 600 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 600 comprises a first portion 641’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641’ having a first cross-sectional area in a first plane and comprising a first surface configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The device 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 642 here has a third cross- sectional area in a third plane. The connecting portion 642 is configured to connect the first portion 641’ to the second portion 641”. In the illustrated embodiment, a connecting interface 630 between the connecting portion 642 and the second portion 641 ” is arranged at an end of the second portion 641”.
The first portion 641’ may have an elongated shape. Similarly, the second portion 641” may have an elongated shape. However, the first portion 641’ and/or second portion 641” may assume other shapes, such as a flat disk e.g. having a width and length being larger than the height, a sphere, an ellipsoid, or any other polyhedral or irregular shape, some of these being exemplified in Figs. 34 - 36.
To provide a frame of reference for the following disclosure, and as illustrated in Figs. 43D - 43L, a first direction 631 is here parallel to the line A-A, to the second plane, and to a length of the second portion 641”. A second direction 633 is here parallel to the line B-B, to the second plane, and to a width of the second portion 641”. The second portion 641” has a first end 632 and a second end 634 opposing the first end 632. The length of the second portion 641” is defined as the length between the first end 632 and the second end 634. The length of the second portion 641” is furthermore extending in a direction being different to the central extension Cl of the connecting portion 642. The first end 632 and second end 634 are separated in a direction parallel to the second plane. Similarly, the first portion 641’ has a length between a first and a second end, the length extending in a direction being different to the central extension C 1 of the connecting portion 642.
The first portion 641’, connecting portion 642 and second portion 641” may structurally form one integral unit. It is however also possible that the first portion 641 ’ and the connecting portion 642 structurally form one integral unit, while the second portion 641” form a separate unit, or, that the second portion 641” and the connecting portion 642 structurally form one integral unit, while the first portion 641 ’ form a separate unit.
Additionally, or alternatively, the second portion 641” may comprise a removable and/or interchangeable portion 639 as described in other parts of the present disclosure.
In the following paragraphs, some features and properties of the second portion 641” will be described. It is however to be understood that these features and properties may also apply to the first portion 641’.
The second portion 641” has an intermediate region 638, and a distal region 640. A proximal region may be present, as described in other parts of the present disclosure. The intermediate region 638 is defined by the connecting interface 630 between the connecting portion 642 and the second portion 641”, and the distal region 640 extends from the connecting interface 630 between the connecting portion 642 and the second portion 641” to the second end 634.
The first surface 614 configured to face and/or engage the first tissue surface 616 of the first side 612 of the tissue portion 610 may be substantially flat. In other words, the first portion 641’ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion 641’, facing away from the tissue portion 610, may be substantially flat. Similarly, the second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 may be substantially flat. In other words, the second portion 641” may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion 641”, facing away from the tissue portion 610, may be substantially flat.
The second portion 641” may be tapered from the first end 632 to the second end 634, thus giving the second portion 641” different heights and/or widths along the length of the second portion 641”. The second portion may also be tapered from each of the first end 632 and second end 634 towards the intermediate region 638 of the second portion 641”.
Still referring to Figs. 43D - 43L, the second portion 641” and connecting portion 642 here form a connecting interface 630. Furthermore, the second portion 641” has a lengthwise cross-sectional area along the first direction, wherein a second lengthwise cross-sectional area 690 is smaller than a first lengthwise cross-sectional area 689 and wherein the first lengthwise cross- sectional area 689 is located closer to the connecting interface 630 with regard to the first direction 631. Hereby, a tapered second portion is formed, being tapered towards the second end 634. The lengthwise cross-sectional area of the second portion 641” may decrease continuously from an end of the intermediate region 638 towards the second end 634, as illustrated for example in Fig. 43G. The decrease may be linear, as illustrated for example in Fig. 43G. However, other types of decreasing lengthwise cross-sectional areas are possible, such as a parabolic, exponential, stepwise, or stepwise with radiused edges between each step thus forming a smooth rounded contour.
Figs. 43E and 43F illustrate how the lengthwise cross-sectional area decrease over the length of the second portion 641” towards the second 634, as viewed along the line A-A. Fig. 43E illustrate the first lengthwise cross-sectional area 689, and Fig. 43F illustrate the second lengthwise cross-sectional area 690.
In some embodiments, the lengthwise cross-sectional area may decrease over a majority of the length of the second portion towards the second end 634. In some embodiments, a decrease of the lengthwise cross-sectional area over at least ! of the length of the second portion towards the second end 634 may be sufficient. In the example illustrated in Fig. 43G, the lengthwise cross- sectional area decrease over about 85% of the length of the second portion.
With the second portion 641” having rotational symmetry along the first direction 631 , as illustrated for example in Fig. 43D, the shape of the second portion 641” may be conical.
As illustrated in fig. 43H, the second portion 641” may have an upper surface, which include the second surface 620 configured to engage a second tissue surface of the second side of the tissue portion as discussed in other parts of the present disclosure, wherein the upper surface or second surface 620 is substantially flat and parallel to the second plane. In some embodiments the upper surface may be substantially perpendicular to the central extension C 1 of the connecting portion 642. Hereby, the second surface may be configured to lay flat against the second side of the tissue portion. In such embodiments, a lower surface of the second portion 641”, opposite the second surface 620 and facing away from the first portion 641’, may be configured to taper towards the second end 634, thus achieving the decreasing lengthwise cross-sectional area along the first direction 631 towards the second end 634.
Fig. 431 illustrate an embodiment wherein the lengthwise cross-sectional area decreases in a stepwise manner towards the second end 634 of the second portion 641”. Here, the second portion 641” has three major segments 692, 693, 694 having substantially constant diameter and each respective diameter being smaller moving towards the second end 634, being connected by intermediate segments 695, 696, wherein the diameter decreases along the first direction 631. Other variations of major segments having substantially constant diameter, and intermediate segments, having a decreasing diameter along the first direction 632, are possible, such as at least two major segments connected by a single intermediate segment with decreasing diameter, at least four major segments connected by three intermediate segments with decreasing diameter, and so on.
Referring now to figs. 43 J - 43L, an implantable energized medical device similar to the one illustrated in fig. 43H is illustrated. As can be seen in the perspective view of Fig. 43 J, the second portion 641” has a decreasing lengthwise cross-sectional area towards the second end. The upper surface 697 is also visible in this view, being substantially flat and providing a contact area to the second tissue surface 622. The first lengthwise cross-sectional area 689 is larger than the second cross-sectional area 690, as can be seen in figs. 43J - 43L, and the first lengthwise cross- sectional area 689 is located closer to the connecting interface between the connecting portion 642 and the second portion 641” with regard to the first direction.
With reference to fig. 44, an embodiment of an implantable remote unit 600, which may be referred to as a remote unit in other parts of the present disclosure, will be described. The remote unit 600 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 600 comprises a first portion 641’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 641’ having a first cross-sectional area in a first plane and comprising a first surface 614 configured to face and/or engage a first tissue surface of the first side 612 of the tissue portion 610. The remote unit 600 further comprises a second portion 641” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 641” having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface of the second side 618 of the tissue portion 610. The remote unit 600 further comprises a connecting portion 642 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 642 here has a third cross-sectional area in a third plane. The connecting portion 642 is configured to connect the first portion 641’ to the second portion 641”.
At least one of the first portion and the second portion comprises at least one coil embedded in a ceramic material, the at least one coil being configured for at least one of: receiving energy transmitted wirelessly, transmitting energy wirelessly, receiving wireless communication, and transmitting wireless communication. In the illustrated embodiment, the first portion 641’ comprises a first coil 658 and a second coil 660, and the second portion 641” comprises a third coil 662. The coils are embedded in a ceramic material 664
As discussed in other part of the present disclosure, the first portion 641 ’ may comprise a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter, and further the first portion 641 ’ may comprise a first wireless communication receiver. The first wireless energy receiver and the first wireless communication receiver may comprise the first coil. Accordingly, the first coil may be configured to receive energy wirelessly, and/or to receive communication wirelessly.
By the expression “the receiver/transmitter comprising the coil” it is to be understood that said coil may form part of the receiver/transmitter.
The first portion 641’ comprises a distal end 665 and a proximal end 666, here defined with respect to the connecting portion 642. In particular, the proximal end 665 is arranged closer to the connecting portion 642 and closer to the second portion 641” when the remote unit 600 is assembled. In the illustrated embodiment, the first coil 658 is arranged at the distal end 665.
The first portion 641 ’ may comprise an internal wireless energy transmitter, and further a first wireless communication transmitter. In some embodiments, the internal wireless energy transmitter and/or the first wireless communication transmitter comprises the first coil 658. However, in some embodiments the internal wireless energy transmitter and/or the first wireless communication transmitter comprises the second coil 660. The second coil 660 is here arranged at the proximal end 665 of the first portion 641’. Such placement of the second coil 660 may provide for that energy and/or communication signals transmitted by the second coil 660 will not be attenuated by internal components of the first portion 641’ when being transmitted to the second portion 641”.
In some embodiments, the first wireless energy receiver and the internal wireless energy transmitter comprises a single coil embedded in a ceramic material. Accordingly, a single coil may be configured for receiving energy wirelessly and for transmitting energy wirelessly. Similarly, the first wireless communication receiver and the first wireless communication transmitter may comprise a single coil embedded in a ceramic material. Even further, in some embodiments a single coil may be configured for receiving and transmitting energy wirelessly, and for receiving and transmitting communication signals wirelessly.
The coils discussed herein are preferably arranged in a plane extending substantially parallel to the tissue portion 610.
The second portion 641” may comprise a second wireless energy receiver, and/or a second wireless communication receiver. In some embodiments, the third coil 662 in the second portion 641” comprises the second wireless energy receiver and/or the second wireless communication receiver.
The second portion 641” comprises a distal end 668 and a proximal end 670, here defined with respect to the connecting portion 642. In particular, the proximal end 668 is arranged closer to the connecting portion 642 and closer to the first portion 641 ’ when the remote unit 600 is assembled. In the illustrated embodiment, the third coil 662 is arranged at the proximal end 668 of the second portion 641”. Such placement of the third coil 662 may provide for that energy and/or communication signals received by the third coil 662 will not be attenuated by internal components of the second portion 641” when being received from the first portion 641’.
The first portion 641’ may comprise a first controller 300a connected to the first coil 658, second coil 660, and/or third coil 662. The second portion 641” may comprise a second controller 300b connected to the first coil, 658, second coil 660, and/or third coil 662.
In the illustrated embodiment , the first portion 641’ comprises a first energy storage unit 304a connected to the first wireless energy receiver 308a, i.e. the first coil 658. The second portion comprises a second energy storage unit 304b connected to the second wireless energy receiver 308b, i.e. the third coil 662. Such an energy storage unit may be a solid-state battery, such as a thionyl-chloride battery.
In some embodiments, the first coil 658 is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the first coil 658 and/or the second coil 660 may be configured to wirelessly transmit energy stored in the first energy storage unit 304a to the third coil 662, and the third coil 662 may be configured to receive energy transmitted wirelessly by the first coil 658 and/or the second coil 660 and store the received energy in the second energy storage unit 304b.
The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b. Hereby, charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow. Thus, a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first and/or second coil and the third coil.
Figs. 45A and 45B illustrate a gear arrangement and magnetic coupling for coupling the remote unit to an implant exerting force on a body part, and in particular a gear arrangement for transferring mechanical movement through an outer housing of the device or an outer housing of the second portion 641”.
The housing 484 of the device or second portion 641” may be present in some embodiments of the device. In such embodiments, the housing 484 is configured to enclose, at least, the controller (not shown), motor M, any receivers and transmitters if present (not shown), and any gear arrangements G, Gl, G2 if present. Hereby, such features are protected from bodily fluids. The housing 484 may be an enclosure made from one of or a combination of: a carbonbased material (such as graphite, silicon carbide, or a carbon fiber material), a boron material, a polymer material (such as silicone, Peek®, polyurethane, UHWPE or PTFE,), a metallic material (such as titanium, stainless steel, tantalum, platinum, niobium or aluminum), a ceramic material (such as zirconium dioxide, aluminum oxide or tungsten carbide) or glass. In any instance the enclosure should be made from a material with low permeability, such that migration of fluid through the walls of the enclosure is prevented.
The remote unit may comprise at least part of a magnetic coupling, such as a magnetic coupling part 490a. A complementary part of the magnetic coupling, such as magnetic coupling part 490b, may be arranged adjacent to the remote unit 600, so as to magnetically couple to the magnetic coupling part 490a and form the magnetic coupling. The magnetic coupling part 490b may form part of an entity not forming part of the remote unit 600. However, in some embodiments the second portion 641” comprises several chambers being hermetically sealed from each other. Such chambers may be coupled via a magnetic coupling as discussed herein. The magnetic coupling 490a, 490b provide for that mechanical work output by the remote unit 600 via e.g. an electric motor can be transferred from the device to an implantable medical device for stretching the stomach wall of the patient. In other words, the magnetic coupling 490a, 490b provides for that mechanical force can be transferred through the housing 484.
The coupling between components, such as between a motor and gear arrangement, or between a gear arrangement and a magnetic coupling, may be achieved by e.g. a shaft or the like.
In some embodiments, for example as illustrated in Fig. 45A, a force output of a motor MO in the second portion 641 ” is connected to the magnetic coupling part 490a. The magnetic coupling part 490a transfers the force output from the motor MO to the magnetic coupling part 490b, i.e. via the magnetic coupling 490a, 490b. The force output transferred via the magnetic coupling 490a, 490b here has a torque Tl, which is substantially the same torque as delivered by the motor MO. The magnetic coupling part 490b is connected to a gear arrangement G, located external to the device, for example in a medical implant configured to exert force on a body part, or intermediate to a medical implant configured to exert force on a body part. The gear arrangement G is configured to increase the torque of the force delivered via the magnetic coupling 490a, 490b to deliver a force with torque T2 being higher than torque Tl to a medical implant. Consequently, low torque may be provided by the motor MO, i.e. a relatively small force with high angular velocity, which is transferred via the magnetic coupling 490a, 490b before the torque is increased via gear arrangement G to achieve a relatively large force with low angular velocity. Hereby, the magnetic coupling 490a, 490b may utilize relatively weak magnetic forces to transfer the mechanical work through the housing 484 of the device without the risk of slipping between the magnetic coupling parts 490a, 490b.
In some embodiments, for example as illustrated in Fig. 45B, a force output of a motor MO in the second portion 641” is connected to a first gear arrangement Gl, which in turn is coupled to the magnetic coupling part 490a. The motor MO here provides a mechanical force with torque TO. The magnetic coupling part 490a transfers the force output from the motor MO to the first gear arrangement Gl. The first gear arrangement Gl is configured to increase the torque of the force delivered from the motor MO to deliver a force with a higher torque Tl to the magnetic coupling 490a, 490b. The magnetic coupling part 490a transfers the force with torque Tl to the magnetic coupling part 490b. The magnetic coupling part 490b is connected to a second gear arrangement G2, located external to the device, for example in a medical implant configured to exert force on a body part, or intermediate to a medical implant configured to exert force on a body part. The second gear arrangement G2 is configured to increase the torque of the force delivered via the magnetic coupling 490a, 490b to deliver a force with torque T2 being higher than torque Tl, and thus higher than torque TO, to a medical implant. Consequently, low torque may be provided by the motor MO, i.e. a relatively small force with high angular velocity. The torque of the force provided by the motor MO is then increased by the first gear arrangement Gl, before the force is transferred via the magnetic coupling 490a, 490b. The torque of the force transferred via the magnetic coupling 490a, 490b is then yet again increased via the second gear arrangement G2 to achieve a relatively large force with low angular velocity. Hereby, the magnetic coupling 490a, 490b may utilize relatively weak magnetic forces to transfer the mechanical work through the housing 484 of the device without the risk of slipping between the magnetic coupling parts 490a, 490b. Furthermore, since some of the torque increase is made within the second portion 641”, and a remaining portion of the torque increase is made external to the device and the second portion 641”, the gear arrangements Gl, G2 may be sized and configured appropriately to share the work of increasing the torque.
Fig. 45C schematically illustrates an energy storage 304b connected to a wireless energy transmitter 308. The energy storage 304b and the wireless energy transmitter 308 are arranged in one portion or chamber of the second portion 641”. Furthermore, a wireless energy receiver 308e is arranged in another portion or chamber of the second portion 641”. The portions or chambers may be separated or defined by respective housings, external walls and/or internal walls 484a, 484b. The wireless energy transmitter 308d is configured to wirelessly transmit energy to the wireless energy receiver 308e. Hereby, an internal energy transfer is achieved within the second portion 641”. The wireless energy transmitter 308d and wireless energy receiver 308e may comprise one or more coils, respectively. The wireless energy receiver 308e may be connected to a further energy storage 680 arranged within the second portion 641”. Such energy storage 680 may be connected to a medical implant, such that the energy storage 680 can deliver energy to the medical implant. In some embodiments however, the wireless energy receiver 308e is directly connected to a medical implant to deliver energy directly to the medical implant, thus omitting the energy storage 680.
Fig. 46A shows an embodiment of a hydraulic pump 604 which may be used as a part of a hydraulic operation device for operating any of the hydraulic embodiments of the medical device disclosed herein. The hydraulic pump 604 may be placed in, or in direct connection with a vessel member of the system, or may be placed in a remote unit. In the embodiment of fig. 46a, the hydraulic pump 604 is a peristaltic hydraulic pump shown in cross-section. The implantable peristaltic pump 604 comprises a deflectable hollow member 401 for fluid transportation, in form of a tubing made from a resilient material, such as an elastomeric polymer material, such as silicone, Parylene® coated silicone, NBR, Hypalon, Viton, PVC, EPDM, Polyurethane or Natural Rubber. The deflectable hollow member 401 is placed between a first portion of a fluid conduit 65 la at the inlet of the hydraulic pump 604 and a second portion of a fluid conduit 65 lb at the outlet of the hydraulic pump 604. The deflectable hollow member 401 is adapted to be deflected by operable compression members 402 or “wipers”, adapted to engage and compress the hollow member 401, and thus transport the hydraulic fluid. The compression member 402 is propelled by the motor MO via a gear system G. The hollow member 401 is placed inside a peristaltic pump housing 403, such that the hollow member 401 is compressed between the operable compression member 402 and the housing 403. The peristaltic pump 604 is a sealed pump which means that fluid will not leak through the pump even at standstill. As the peristaltic pump 604 is a sealed pump no additional valve is needed to keep the fluid through the fluid conduits 65 la, 65 lb closed.
The deflectable hollow member 401 is connected to or integrated with fluid conduits 65 la, 65 lb, which in turn are connectable with fluid conduits of the hydraulic operation devices in any of the embodiments described herein. When the compression member 402 is propelled in a counterclockwise direction, it creates a peristaltic wave which presses hydraulic fluid through the hollow member 401 and further through the second portion of the fluid conduit 65 lb. When the compression member 402 is propelled in a clockwise direction, it creates a peristaltic wave which presses hydraulic fluid through the hollow member 401 and further through the first fluid conduit 651a. According to one embodiment, the system could comprise several peristaltic pumps 604 of the embodiment of fig. 46A and 46B. A first peristaltic pump 604 could be connected to a first hydraulic member or cuff and a second peristaltic pump 604 could be connected to a second hydraulic member or cuff and so on. As such, the different cuffs can be individually adjusted by running different peristaltic pumps 604 such that different pressures can be exerted on different portions of the blood vessel.
Fig. 46B shows the peristaltic pump 604 in accordance with the embodiment of fig. 46A in a side view in which the electrical motor MO and gear system G for propelling the compression member 402 is shown. The electrical motor MO is adapted to transform electrical energy to mechanical work. The electrical motor MO may receive electrical energy from a receiving unit receiving wireless energy transmitted from an energy transmitting unit external to the body of the patient, and/or may receive electrical energy stored in an implantable energy storage unit. The electrical motor MO is in the embodiment of figs. 46A and 46B a brush-less direct current electrical motor MO, but in alternative embodiment the electrical motor could be an electrical motor MO selected from an alternating current (AC), a linear electrical motor, an axial electrical motor, a piezo-electric motor, a multiple phase motor, such as a three-phase motor, a bimetal motor, and a memory metal motor.
The force output of the electrical motor MO is in connection with a force input of a gear system G adapted to receive mechanical work having a first force and first velocity, and output mechanical work having a different second force and a different second velocity, such that the high velocity movement supplied by the electrical motor MO is transformed to low velocity movement with increased force. The gear system G may for example comprise a gear system having the configuration such as the gear system G described with reference to figs. 47A and 47B. In alternative embodiments, it is conceivable that the gear system G comprises a transmission system of some other configuration, such as a conventional gear wheel system, a worm gear system or a belt transmission system.
Fig. 46C shows an alternative embodiment to the peristaltic pump 604 shown in fig. 46A, the difference being that in the embodiment of fig. 46C, the peristaltic pump comprises three rotating compression members 402 for successively compressing the deflectable hollow member 401.
Fig. 47A shows an embodiment of an implantable gear system G which may be used as a transmission for any of the electrical motors shown herein, for the purpose of transforming the high velocity movement supplied by the electrical motor to low velocity movement with increased force. The implantable gear system G of fig. 47A is adapted to receive mechanical work having a first force and first velocity, and output mechanical work having a second, different force and a second different velocity. The gear system G comprises a force input 442 connected to an operable element 443 ’ adapted to engage a first gear 444 having the shape of a hollow cylinder, comprising a first number of teeth 444t, for example 160, on the peripheral outside thereof, and a second gear 445 having the shape of a hollow cylinder, comprising a greater number of teeth 445t than the first gear, for example 462, on the inside surface thereof. The operable element 443 ’ is adapted to engage the inside 444a of the first gear 444, such that the outside 444b of the first gear 444 is pressed against the inside 445a of the second gear 445 such that the teeth 444t of the first gear 444 are interengaged with the teeth 445t of the second gear 445 in position POi interspaced by positions (for example the position PO2) at which the teeth are not interengaged. The operation of the operable element 443’ advances the position POi and thereby causes relative rotation between the first gear 444 and the second gear 445. In the embodiment shown in fig. 47A, the second gear 445 comprises two more teeth 445t than the first gear 444, resulting in the first gear 444 rotating 2/160 or 1/80 of a revolution for each revolution that the operable element 443’ performs, which results in a transmission of 80 times, i.e. the force output (449 of fig. 47B) provides a force with 1/80 of the velocity and 80 times the force, thus increasing the force which can be exerted on the stomach wall by the electrical motor, 80 times. In the embodiment shown in fig. 47A the operable element 443’ slides radially against the inner surface of the first gear 444. For reducing the friction a lubricating fluid may be present in the gear system G, it is further conceivable that the operable element 443’ or the surface against which the operable implant 443’ slides may comprise a selflubricating material, such as Graphalloy, Nyliol or PTFE.
Fig. 47B shows the gear system G in a sectional side view, in an embodiment in which the gear system G comprises a third gear 446 having an inside 446a comprising the same amount of teeth 446t as the outside 444b of the first gear 444. The teeth 446t of the third gear 446 are adapted to interengage with the teeth of the first gear 444 such that the third gear 446 rotates in relation to the second gear 445, along with the interengaged position (POi of fig. 47A). The third gear 446 is in connection with a force output 449 of the gear system 440 by means of a radially extending connecting structure 447 for transferring force from the third gear 446 to the force output 449.
The gear system G of figs. 47A and 47B could for example be made of a metallic material, plastic material or ceramic material. In one embodiment, the gear system is made from non- metallic and/or non-magnetic material, such that the gear system G does not affect the energy transfer to an implantable energy receiver. The gear system G may be lubricated with a biocompatible lubricant, such as hyaluronic acid, and may, for that purpose, be placed inside a reservoir adapted to hold a hydraulic fluid, which also may serve as a lubricant. The gear system G may be encapsulated by an enclosure for preventing bodily fluids from affecting the gear system G and/or the in-growth of human tissue in the gear system and/or the leakage of hydraulic and/or lubricating fluids. The enclosure may be a non-metallic and/or non-magnetic enclosure, such that the material of the enclosure does not affect the ability of transferring wireless energy to a wireless energy receiver of the operable implant. The gear system may be encapsulated separately or may be encapsulated along with an electrical motor (such as shown in figs. 46A,46B) or alongside additional components (such as shown in figs. 48 and 49A).
Fig. 48 shows a cross-sectional view of an electrical motor MO in combination with a gear system G for propulsion of a hydraulic pump 604. The hydraulic pump described with reference to fig. 48 may be used as a part of a hydraulic operation device for operating any of the hydraulic embodiments of the medical device disclosed herein. The hydraulic pump 604 may be placed in, or in direct connection with a vessel member of the system, or may be placed in a remote unit, for example replacing part of the hydraulic operation device placed in the remote unit described with reference to fig. 27. The electrical motor MO is connected to the controller 300 which in turn is connected to an energy storage unit 40. The energy storage unit 40 may be a battery, a chargeable battery or a capacitor by means of which energy can be stored in the body of the patient.
The controller 300, the energy storage unit 40 and the motor MO and gear system G the may be enclosed by a housing 484 such that the controller 300 is protected from bodily fluids. The housing 484 may be an enclosure made from one of or a combination of: a carbon based material (such as graphite, silicon carbide, or a carbon fiber material), a boron material, a polymer material (such as silicone, Peek®, polyurethane, UHWPE or PTFE,), a metallic material (such as titanium, stainless steel, tantalum, platinum, niobium or aluminum), a ceramic material (such as zirconium dioxide, aluminum oxide or tungsten carbide) or glass. In any instance the enclosure should be made from a material with low permeability, such that migration of fluid through the walls of the enclosure is prevented.
Turning now to the hydraulic pump 604 shown in fig. 48. In the embodiment shown in fig. 48, the force output 449 of the gear system G is threaded 449t and engages a correspondingly threaded portion 45 It of the movable wall 451 such that the rotating force created by the motor MO and gear system G is transferred to a linear force moving the movable wall 451. The threaded force output 449 is enclosed by pleated bellows portions 452 both above and below the movable wall 451 such that the threaded force output 449 is protected from the fluid in the lumens of the reservoirs 607a, 607b. The reservoirs 607a, 607b has a common moveable wall 451 for changing the volume of the implantable fluid reservoirs 607a, 607b and thereby increasing fluid in the first fluid reservoir 607a simultaneously with decreasing fluid in the second fluid reservoir 607b and vice versa. The pump 604 is a sealed pump which means that fluid will not leak through the pump 604 even at standstill. As the pump 604 is a sealed pump no additional valve is needed to keep the fluid through the fluid conduits 65 la’, 65 lb closed. The movable wall pump 604 of fig. 48 is a sealed pump which means that fluid will not leak through the pump 604 even at standstill.
Fig. 49A shows a cross-sectional view of a hydraulic pump comprising two expandible reservoirs 607a, 607b. The hydraulic pump 604 described with reference to fig. 49A may be used as a part of a hydraulic operation device for operating any of the hydraulic embodiments of the medical device disclosed herein. The hydraulic pump 604 may be placed in, or in direct connection with a vessel member of the system, or may be placed in a remote unit, for example replacing part of the hydraulic operation device placed in the remote unit described with reference to fig. 27. The hydraulic pump 604 of fig. 49A comprises an encapsulated motor MO, gear system G, controller 300 and energy storage unit 40 being identical to that described with reference to fig. 48. Turning to the hydraulic pump 604, the force output 449 is, in the embodiment described in fig. 49A a hollow shaft equipped with inner threads (not shown) adapted to engage outer threads 453t of a threaded member 453, such that the interaction between the hollow shaft 449 and the threaded member 453 transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force. The threaded member 453 is connected to a radially extending engaging member 454 adapted to engage the first and second reservoirs 607a, 607b containing a hydraulic fluid. The reservoirs 607a, 607b may be fixated to the radially extending engaging members 454, for example by means of an adhesive, such that the reservoirs 607a, 607b are forced to expand when the radially extending engaging member 454 is moved upwards in the expanding direction of the reservoirs 607a, 607b. The first reservoir 607a is connected to a first fluid conduit and the second reservoir 607b is connected to a second fluid conduit 651b. The embodiment shown in fig. 49A further comprises a pleated bellows portions 452 for encapsulating and protecting the force output 449 and the threaded member 453 from bodily fluids. The reservoirs 607a, 607b are preferably made from medical grade implantable silicone or Parylene® coated medical grade implantable silicone, but may in alternative embodiments be made from another resilient material such as NBR, Hypalon, Viton, PVC, EPDM, Polyurethane or Natural Rubber. When the reservoirs 607a, 607b are compressed and expanded they function as hydraulic pumps for moving hydraulic fluid any of the hydraulic embodiments herein. According to one embodiment, the system could comprise several pumps 604 of the embodiments of figs. 48 and 49A. A first pump 604 could be connected to a first hydraulic member or cuff and a second pump 604 could be connected to a second hydraulic member or cuff and so on. As such, the different cuffs can be individually adjusted by running different pumps 604 such that different pressures can be exerted on different portions of the blood vessel.
Fig. 49B shows a cross-sectional view of a hydraulic pump 604 similar to the hydraulic pump or the embodiment of fig. 49A. The hydraulic pump 604 described with reference to fig. 49B may be used as a part of a hydraulic operation device for operating any of the hydraulic embodiments of the system disclosed herein. The hydraulic pump 604 may be placed in, or in direct connection with a vessel member of the system, or may be placed in a remote unit, for example replacing part of the hydraulic operation device placed in the remote unit described with reference to fig. 27. In the embodiment of fig. 49B, the hydraulic pump 604 comprises one expandable reservoir 607. The hydraulic pump 604 comprises an encapsulated motor MO, gear system G, controller 300 and energy storage unit 40. The motor MO is configured to generate force in a radial direction by rotation of the force output in the form of a shaft 481. The shaft 481 is equipped with outer threads 48 It adapted to engage inner threads 483t of a compression member 483, such that the interaction between the threaded shaft 481, 48 It and the threaded portion 483t of the compression member 483 transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T. The axial force acts on the compression member 483 which engages a first resilient wall 602a of the compressible reservoir 607 for compressing the compressible reservoir 607 and thus increasing the pressure on a hydraulic fluid in the compressible reservoir 607. The compression member 483 may be fixated to the first resilient wall portion 602a by means of an adhesive, such that the reservoir 607 is forced to expand when the compression member 483 moves in the expanding direction of the reservoir 607. The reservoir 607 is connected to a fluid conduit (not shown) for conducting hydraulic fluid from the compressible reservoir to the and from the reservoir 607. The reservoir 607 is preferably made from medical grade implantable silicone or Parylene® coated medical grade implantable silicone, but may in alternative embodiments be made from another resilient material such as NBR, Hypalon, Viton, PVC, EPDM, Polyurethane or Natural Rubber. When the reservoir 607 is compressed and expanded it functions as hydraulic pump for moving hydraulic fluid in any of the hydraulic embodiments herein.
The hydraulic pump 604 further comprises at least one bearing 482 for the shaft 481 placed between the gear system G and the compressible reservoir 607. The bearing 482 is configured to withhold at least half of the force in the axial direction, for reducing the axial load on the motor MO and the gear system G which is caused by the compression of the reservoir 607. In the embodiment shown in fig. 49B, the bearing 482 is a ball bearing, but in other embodiments the bearing may comprise a roller bearing or a plain bearing preferably including a self-lubricating material such as PTFE or HDPE.
The gear system G is connected to the motor MO, and placed between the motor MO and transmission T and adapted to receive mechanical work via the shaft 481 having a force and a velocity, and output mechanical work having a stronger force and a lower velocity. The compressible reservoir 607 comprises a first resilient wall portion 602a and a second resilient wall portion 602b, wherein the first resilient wall portion 602a is more resilient than the second resilient wall portion 602b.
In alternative embodiments, the compression member 483 may be directly connected to the first resilient wall portion 602a, and in such embodiments, the threaded portion 483t may be integrated in the first resilient wall portion 602a.
In the embodiment shown in fig. 49B, the hydraulic pump 604 further comprises a pressure sensor 606 connected to the compressible reservoir 607 and configured to sense the pressure in the compressible reservoir 607. The pressure sensor 606 is integrated in, and placed on the outside of, the second resilient wall portion 602b of the compressible reservoir 607. The pressure sensor 606 comprises a strain gauge-based pressure sensor 606 such as for example described with reference to figs. 51 A - 5 IE. It is important to measure strain or pressure in or exerted by the vessel member, as too high strain or pressure risks damaging the blood vessel having the aneurysm or hampering the blood flow to the tissue of the blood vessel, which in the long term could lead to damage of the tissue and in the worst-case lead to necrosis.
The compressible reservoir 607 in the embodiment shown in fig. 49B comprises a first and second resilient wall portion 602a, 602b in the form of a first and second circular diaphragm 602a, 602b. The first resilient wall portion 602a has a convex shape facing the compression member 483, and the second resilient wall portion 602b has a convex shape facing away from the compression member 483 and a lumen is formed between the two diaphragms 604a, 604b, and being enclosed by the concave surfaces of the diaphragms 604a, 604b. The first resilient wall portion 604a is configured to be compressed and thus inverted, such that the part of the first resilient wall portion 604a facing the compression member 483 assumes a concave shape facing the compression member 483, and as such, a convex shape is formed towards the lumen of the compressible reservoir 604. The inverted, convex, portion of the first resilient wall portion 604a thus enters the concave shape of the second resilient wall portion 604b. The portion of the compression member 483 configured to engage the first resilient wall portion 604a comprises a convex portion for facilitating the inversion of the convex portion of the first resilient wall portion 604a. In the embodiment shown in fig. 49B, the first resilient wall portion 604a is more resilient than the second resilient wall portion 604b such that the compressible reservoir 604 can create a suction when the compression member 483 moves in the direction away from the compressible reservoir 604 thus enabling the compressible reservoir 604 to expand. In the embodiment shown in fig. 49B, a major portion of the first resilient wall portion is made from a material having a modulus of elasticity (E) which is less than 70% or the modulus of elasticity (E) of the material of a major portion of the second resilient wall portion 604b. In alternative embodiments, it is conceivable that the first and second resilient wall portions 604a, 604b are made from the same material, but with the second resilient wall portion 604b being more than 1,5 times as thick as the first resilient wall portion 604a. In the embodiment shown in fig. 49B, the two diaphragms 604a, 604b are pressed against each other, for creating the sealed lumen between the first and second diaphragm, by means of a fixation ring 485, which is screwed into the housing 484.
In the embodiment shown in fig. 49B, the hydraulic pump further comprises a shaft sealing 486, which is a sealing engaging the shaft and thus creating a seal between the portion of the pump housing 484 comprising the motor MO, gear system G, energy storage unit 40 and controller 300, and the portion of the pump housing 484 comprising the compressible reservoir 604. The seal reduces the risk that hydraulic fluid that may leak from the compressible reservoir 604 will come in contact with any of the motor MO, gear system G, energy storage unit 40 and/or controller 300. In the embodiment shown in fig. 49B, the shaft sealing comprises a spring-loaded PTFE sealing 486. A spring engages the housing 484 of the hydraulic pump 604 and the PTFE sealing for creating a constant elastic pressure between the sealing and the shaft 481 which ensures a self-lubricating tight seal. In alternative embodiments, the spring may be replaced by a different type of elastic element, such as an elastic element made from an elastomer. In alternative embodiment, the shaft sealing 486 could be a shaft sealing made from another self-lubricating material such as HDPE.
The hydraulic pump 604 of fig. 49B is enclosed by a pump housing 484, which in the embodiment shown in fig. 49B is a titanium housing 484. In alternative embodiments, the housing could be made from another medical grade metal alloy, such as medical grade stainless steel or could comprise a ceramic material such as zirconium carbide, or a stiff medical grade polymer material such as Ultra-high-molecular-weight polyethylene (UHMWPE) or Polytetrafluoroethylene (PTFE) or a thermoplastic polyester such as polylactide (PLA). The housing could also comprise at least one composite material, such as any combination of metallic/ceramic and polymer materials or a polymer material reinforced with organic or inorganic fibers, such as carbon or mineral fibers.
Fig. 49C shows a cross-sectional view of a hydraulic pump 604 similar to the hydraulic pump of the embodiment of fig. 49B. In the embodiment of fig. 49C, the hydraulic pump comprises one expandible reservoir 604. The hydraulic pump 604 comprises a housing 484 comprising a first and a second chamber Cl, C2 separated from each other by a barrier 484’ . Just as in the embodiment of fig. 49C, the first chamber Cl comprises the motor MO configured for transforming electrical energy to mechanical work and the gear system gear system G adapted to receive mechanical work having a first force and first velocity, and output mechanical work having a different second force and a different second velocity, such that the high velocity movement supplied by the electrical motor MO is transformed to low velocity movement with increased force. The output mechanical work having the different second force and different second velocity acts on a shaft 481 which transfers the force to a magnetic coupling 490a, 490b for transferring mechanical work from the motor MO to an actuator in the form of a compression member 483 for compressing the expandible reservoir 604 for pressing a hydraulic fluid through the conduit 65 la. The magnetic coupling 490a, 490b comprises a first disc shaped member 490a mounted to the shaft 481 such that the first disc shaped member 490a rotates along with the shaft 481. The shaft 481 is supported by ball bearings 482 assisting in the centering of the shaft 481.
The first disc shaped member 490a comprises magnets (or a material susceptible to magnetic fields) 491 evenly distributed axially in a circular formation on the distal surface of the first disc shaped member 490a.
The barrier 484’ separates the first chamber Cl of the housing 484 from the second chamber C2 of the housing. In the embodiment shown in fig. 49C, the barrier 484’ is made from the same material as the outer wall of the housing 484, i.e. medical grade titanium. In the embodiment shown in fig. 49C the barrier is materially integrated with the portion of the outer wall of the housing 484 enclosing the second chamber C2. However, in other embodiments it is equally conceivable that the barrier is materially integrated with the portion of the outer wall of the housing 484 enclosing the first chamber Cl. In any event, the purpose is the both the first and second chambers C2 should be hermetically enclosed and separated from each other.
The second part of the magnetic coupling comprises a second disc shaped member 490b positioned in the second chamber C2 and held in place by a ball bearing 482b being fixated to the inside of the wall of the housing 484 enclosing the second chamber C2 by means of an internal wall portion 498. The second disc shaped member 490b comprises magnets (or a material susceptible to magnetic fields) 491b evenly distributed in a circular formation axially on the distal surface of the first disc shaped member 490b. The magnets 490b of the second disc shaped member 490b are configured to be magnetically connected to the magnets 491a of the first disc shaped member 490a such that the second disc shaped member 490b is dragged by the first disc shaped member 490a by means of the magnetic connection. As such, force from the motor MO is transferred from the first hermetically enclosed chamber Cl to the second hermetically enclosed chamber C2.
The second disc shaped member 490b comprises a threaded shaft which is configured to be placed in and engage with a sleeve of a compression member 483. The sleeve of the compression member 483 comprises inside threads 483t for creating a transmission T that transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T.
The compression member 483 is a disc shaped element having a distal surface engaging a first resilient wall portion 607a of the reservoir 607 for moving the first resilient wall portion 607a and thereby compressing the reservoir 607. The periphery of the compression member 483 comprises a flange 483f extending towards the first chamber Cl in the proximal direction creating a lateral surface area towards the housing 484. The lateral surface of the flange 483f is configured to engage the first resilient wall portion 604a for creating a rolling crease of the first resilient wall portion 604a. The disc shaped compression member 483 is rigid and made from titanium, just as the rest of the housing 484. That the compression member 483 is rigid makes the reservoir 604 stiff.
The reservoir 604 is further enclosed by a second wall portion 604b which is a rigid titanium wall portion through which the conduit 65 la enters the reservoir 604. Compression of the reservoir 604 thus forces the fluid from the reservoir through the conduit 651a. The housing 484 further comprises a transfer channel 478 creating a fluid connection between the second chamber C2 and a portion of the second chamber C2’ placed more distally. The transfer channel ensures that the pressure is the same in the second chamber C2 and distal portion of the second chamber C2’. The distal portion C2’ of the second chamber C2 comprises an expansion portion comprising a resilient membrane 495 configured to move to alter the volume of the distal portion C2’ of the second chamber C2 for compensating for the changes to the volume of the reservoir 604 which is created by the movement of the first resilient wall portion 604a of the reservoir 604. As such, the pressure in the second chamber C2 will be substantially constant. The resilient membrane 495 is in the embodiment shown in fig. 49C made from a medical grade elastic silicone material but may in alternative embodiments be made from another biocompatible polymer material, such as polyurethane.
The hydraulic pump of fig. 49C further comprises a pressure sensor 606 placed on the first resilient wall portion 607a of the chamber 607 for sensing the pressure in the chamber 607. The sensor 606, which may be a pressure sensor of the types described with reference to figs. 51A - 5 IE, is connected to electrical conduits 493 for transferring an electrical sensor signal from the pressure sensor 604 to the controller 300. The electrical conduits 493 passes from the second chamber C2 to the first chamber Cl through an electrically insulating ceramic grommet 494 integrated in the barrier 484’ wall such that the conduits 493 can pass the barrier 484’ without being further insulated which enables the conduits 493 to pass through the barrier 484’ whilst the barrier hermetically separates the first chamber Cl from the second chamber C2. It may be important to measure strain or pressure in or exerted by the medical device, as too high strain or pressure risks hampering the blood flow to the tissue of the stomach wall, which in the long term could lead to damage of the tissue and in the worst-case lead to necrosis.
A first portion 65 la of the fluid conduit is connected to an implantable hydraulic force transfer device 496 comprising a first chamber V 1 configured to house a first fluid, and as such the first portion 65 la of the fluid conduit forms a fluid inlet into the first chamber V 1. The first chamber VI is in connection with a movable wall portion 497 for varying the size of the first chamber V 1. The movable wall portion 497 is in turn connected to a second chamber V2 configured to house a second fluid. The second chamber comprises an outlet formed by a second portion 65 lb of the fluid conduit. The second portion 65 lb of the fluid conduit fluidly connects the second chamber C2 to a conduit (651) in any of the hydraulic embodiments described herein. As such, the implantable hydraulic force transfer device 496 transfers hydraulic force from a remote unit to the vessel member of the system without mixing the first and second fluids.
In the embodiment shown in fig. 49C, the implantable hydraulic force transfer device 496 comprises a cylinder-shaped housing in which the piston-like movable wall portion 497 moves linearly. The piston-like movable wall portion 497 seals against the inner side of the wall of the cylinder-shaped housing such that the first and second chambers VI, V2 remains separated. The implantable hydraulic force transfer device 496 enables the system to have a first fluid in the compressible reservoir 604 and in the first chamber VI of the implantable hydraulic force transfer device 496. This part of the system may be hermetically sealed in such a way that leakage is highly improbable, which enables this part of the system to use a fluid which cannot be allowed to escape into the body, such as an oil-based fluid, such as a silicone oil. The second part of the system, comprising the second chamber C2 of the implantable hydraulic force transfer device 496, the second portion 65 lb of the fluid conduit, and the rest of the hydraulic operation device of the medical device (not shown) will have a second fluid which must be a biocompatible fluid as some level of leakage or diffusion may be hard to avoid. In the second part of the system the fluid could for example be an isotone aqueous fluid, such as a saline solution.
In the embodiment shown in figs. 49a - 49h, the housing 484 and the housing of the implantable hydraulic force transfer device 496 is a titanium housing. However, it is equally conceivable that the housing is made from another biocompatible material such as a medical grade metal alloy, such as medical grade stainless steel or a ceramic material such as zirconium carbide, or a stiff medical grade polymer material such as Ultra-high-molecular-weight polyethylene (UHMWPE) or Polytetrafluoroethylene (PTFE) or a thermoplastic polyester such as polylactide (PLA).
In alternative embodiments, the magnetic coupling described with reference to figs. 49c and 49d could be used in connection with another type of pumps, such as the pumps described with reference to figs. 46A, 46B, 48 and 50. In the alternative, the magnetic coupling could be used in connection with a gear pump. It is also conceivable that the magnetic coupling could be used in connection with a mechanical actuator configured to transfer mechanical force from the magnetic coupling to a medical device to exert a force on a body portion of a patient. The mechanical actuator could be an actuator configured to transfer a rotating force into a linear force, such as the transmission (T) described with reference to figs. 48 - 49H.
Fig. 49D shows a hydraulic pump in an embodiment similar to the embodiment shown in fig. 49C. One difference with the embodiment of fig. 49D in comparison to the embodiment of fig. 49C is that the first coupling part 490a’ comprises magnets 491a’ or material susceptible to magnetic fields which are placed radially along an outer periphery, on the lateral surface, of the cylinder-like first coupling part 490a’. The magnets 491a’ of the first coupling part 490a’ are magnetically connected to magnets 491b’ placed radially on the inner letteral surface of the cylinder-shaped second coupling part 490b’. The magnets 49 la’, 49 lb’ of the first and second coupling parts 490a’, 490b’ are separated from each other by the barrier 484’. The second coupling part 490b’ is connected to a rotatable shaft which is supported by ball bearings 482b being fixated to the inside of the wall of the housing 484 enclosing the second chamber C2 by means of an internal wall portion 498. The rotatable shaft comprises a threaded portion which is configured to be placed in and engage with a sleeve of a compression member 483. The sleeve of the compression member 483 comprises inside threads 483t for creating a transmission T that transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T.
Another difference between the embodiment shown in fig. 49C and the embodiment shown in fig. 49D is in the implantable hydraulic force transfer device 496. In the embodiment shown in fig. 49D, the implantable hydraulic force transfer device 496 comprises a movable wall portion 497’ in the form of a bellows with a pleated flexible wall portion which can be compressed and expanded. The material of the flexible wall portion could be an elastic material, such as an elastic polymer material or a substantially inelastic material such as a metal material forming a metal bellows which is mainly flexible due to its shape. In an alternative embodiment, the flexible wall portion can be purely elastic and thus be without the pleats, which means that the expansion and contraction of the reservoir is done purely based on the elasticity of the material in the flexible wall. The flexible movable wall portion 497’ encloses the first chamber VI and keeps the chamber VI completely separated from the chamber V2. The implantable hydraulic force transfer device 496 enables the system to have a first fluid in the compressible reservoir 604 and in the first chamber VI of the implantable hydraulic force transfer device 496. This part of the system may be hermetically sealed in such a way that leakage is highly improbable, which enables this part of the system to use a fluid which cannot be allowed to escape into the body, such as an oil-based fluid, such as a silicone oil. The second part of the system, comprising the second chamber C2 of the implantable hydraulic force transfer device 496, the second portion 65 lb of the fluid conduit, and the hydraulic components of the implantable medical device (not shown) will have a second fluid which must be a biocompatible fluid as some level of leakage or diffusion may be hard to avoid. In the second part of the system the fluid could for example be an isotone aqueous fluid, such as a saline solution.
Fig. 49E shows an embodiment of a hydraulic pump 604 which is similar to the embodiment shown in fig. 49B. One difference in comparison to the embodiment of fig. 49B is that the compression member 483 has a flat circular surface engaging the first resilient wall portion 604a of the reservoir 604. The flat surface is bonded to the first resilient wall portion 604a such that the first resilient wall portion 604a moves along with the compression member 483. The compression member 483 has a diameter such that a distance 483d is created between the compression member 483 and the portion of the housing facing the compression member 483. The distance is slightly more than two times the thickness of the first resilient wall portion 607a, such that the first resilient wall portion 607a can be folded such that a rolling crease of the first resilient wall portion 607a is created which moves along with the compression member 483. The distance 483d is smaller than the radius (or half cross-sectional distance) of the compression member 483. The distance is 483d is also smaller than half the radius of the compression member 483. The first resilient wall portion 607a, towards the second chamber C2, being either folded or supported by the compression member means that ensures that the reservoir 604 will be substantially stiff which enables the fluid amount in the hydraulically operable medical device connected to the reservoir 604 to remain the same even as the pressure exerted on the hydraulically operable medical device increases.
The embodiment of fig. 49E differs from the embodiment of fig. 49C and 49D in that it only comprises a single chamber Cl. The housing 484 of the hydraulic pump 604 of fig. 49E comprises an expansion portion placed in the proximal portion of the hydraulic pump 604 (on the right side of the hydraulic pump of fig. 49E). The expansion portion comprises a first and second resilient membrane 495a, 495b with a silicone oil filling the space formed between the first and second resilient membranes 495a, 495b. The oil between the first and second resilient membrane 495a, 495b reduces the risk of diffusion of fluids through the expansion portion. The first and second resilient membranes 495a, 495b are placed on two sides of a portion 484” of the housing comprising a hole through which the fluid can travel as the expansion portion compensates for the changes to the volume of the reservoir 607 which is created by the movement of the first resilient wall portion 607a of the reservoir 607. As such, the pressure in the first chamber Cl will be substantially constant. The first and second resilient membranes 495a, 495b are in the embodiment shown in fig. 49E made from a medical grade elastic silicone material but may in alternative embodiments be made from another biocompatible polymer material, such as polyurethane.
Another aspect of having the housings of any of the embodiments herein, is that the atmospheric pressure that the patient exists in may vary. At sea level, the air pressure is about 101 kPa, in a commercial airplane at cruising altitude, the air pressure is about 80 kPa which is about the same as in Mexico city, whereas in La Paz, the highest situated city, air pressure is only 62 kPa. This difference in air pressure affects any gaseous fluid, such as the air present in the chamber Cl in the embodiment of fig. 49E. The reduced atmospheric air pressure means that the gaseous fluid inside of the housing needs to be able to expand if the pressure in the housing should remain the same. If the pressure in the housing would increase 20% - 40%, the motor would have to operate the hydraulic medical device against that pressure which would mean that the motor would have to be more powerful which would require more energy. As the expansion portion comprises a resilient membrane, the expansion portion allows the gaseous fluid in the housing to expand which at least reduces the pressure increase in the housing in response to a reduced atmospheric pressure.
Fig. 49F differs from the embodiment of fig. 49E only in that the chamber Cl is completely filled with a liquid dielectric silicone oil. The liquid fluid could in the alternative be a synthetic single-phase liquid dielectric fluid, such as ElectroCool EC- 100, from Engineered Fluids, or a 2- phase coolant such as Fluorinert or Novec from 3M. The fluid in the chamber Cl is non-conductive and as such does not risk damaging the electrical components placed in the chamber Cl, such as the energy storage unit 40. In the embodiment shown in fig. 49F, the expandible reservoir 604, the conduit 651 and the medical device configured to exert force on the body portion of the patient forms the second chamber and second hydraulic system configured to comprise a second liquid which is a hydraulic liquid configured to transfer force. The second liquid may be an isotone aqueous liquid, such as a saline solution.
In the embodiment shown in fig. 49F, the first chamber comprises the motor MO, the gear system G and the transmission T for transforming the rotating force generated by the motor MO to a linear force for pressing on the expandible reservoir 607. Advantages with having the housing and the first chamber Cl entirely filled with a liquid fluid includes the liquid acting as a cooling agent for components that may produce heat, such as the controller 300, the energy storage unit 40, the motor MO, gear system G, bearing 482 and transmission T, and as a lubricant for components that may require lubrication, such as the motor MO, gear system G, bearing 482 and transmission T
Just as in fig. 49E, the housing 484 of the hydraulic pump 604 comprises an expansion portion 495a, 484”, 495b placed in the proximal portion of the hydraulic pump 604 (on the right side of the hydraulic pump of fig. 49F), such that the housing can expand when the expandable reservoir 604 expands.
In alternative embodiments, the liquid filled first chamber Cl could be used in connection with another type of pump, i.e. the shaft 481 could be connected to another type of pump, such as the pumps described with reference to figs. 46A,46B,48 and 50, or a gear pump.
Fig. 49G shows an embodiment of a hydraulic pump 604 which is similar to the embodiment shown in fig. 49D. The main difference with the embodiment shown in fig. 49G is that it made more compact as the gear system is integrated in the magnetic coupling. The magnetic coupling thus comprises a magnetic gear which transfers a week force with a high velocity into a stronger force with lower velocity. The magnetic coupling/gear comprises a first coupling part 490a’ fixated to the shaft 481 connected to the electrical motor MO such that the first coupling part 490a’ rotates along with the electrical motor MO. The first coupling part 490a’ comprises a first number of magnets 491a’, which in the embodiment shown in fig. 49G is 6 magnets, 3 with each polarity (3 pole pairs). The magnets are placed radially along an outer periphery, on the lateral surface, of the cylinder-like first coupling part 490a’. The second coupling part 490b’ comprises a second number of magnets 491b’, placed radially on the inner letteral surface of the cylindershaped second coupling part 490b’. In the embodiment shown in fig. 49G the second coupling part 490b’ comprises 26 magnets, 13 with each polarity. Between the first coupling part 490a’ and the second coupling part 490b’ there is a stationary part, which is a portion of the barrier 484’. The stationary part comprises a plurality of intermediate ferromagnetic elements 499 thus placed between the first and second coupling parts 490a’, 490b’. The intermediate ferromagnetic elements 499 directs the concentration of the magnetic lines between the magnets 491a’, 491b’ of the first coupling part 490a’ and the second coupling part 490b’. The gear ratio between the first coupling part 490a’ and the second coupling part 490b’ is the number of magnetic pole pairs on the second coupling part 490a’ divided by the number of magnetic pole pairs on the second coupling part 490b’. In the embodiment shown in fig. 49G, the gear ratio is 13/3. The number of intermediate ferromagnetic elements 499 is equal to the sum of pole pairs on the first and second coupling parts 490a’, 490b’. In the embodiment shown in fig. 49G this means that the number of intermediate ferromagnetic elements 499 is 16 (13+3). In operation, this set up of magnetic gear changes the direction of rotation of the coupling, which means that that in operation the second coupling part 490b’ will rotate in the opposite direction and 4,33 times slower than the first coupling part 490a’. The embodiment having a magnetic gear have a number of advantages, for example, the magnetic gear is quiet, does not wear and does not need to be lubricated. In alternative embodiments it is conceivable that the magnetic gear is used in combination with a traditional gear wheel gear-system or a transmission of the kind described with reference to figs. 47A and 47B.
The second coupling part 490b’ is connected to a rotatable shaft which is supported by roller bearings 482 being fixated to the inside of the wall of the housing 484. The rotatable shaft comprises a threaded portion which is configured to be placed in and engage with a sleeve of a compression member 483. The sleeve of the compression member 483 comprises inside threads 483t for creating a transmission T that transforms the radially rotating force generated by the motor MO and the gear system G, to a linear force acting in the axial direction of the shaft 481, and thus makes up a transmission T.
Fig. 49H shows an embodiment of a hydraulic pump 604 which is similar to the embodiment shown in fig. 49G. The main difference with the embodiment shown in fig. 49H is that the expansion portion is replaced with two resilient reservoirs 607’, 607” which are placed in indentations in the housing, on respective two opposite sides of the housing. The two resilient reservoirs 607’, 607” are configured to expand and contract to compensate for the changes to the volume of the reservoir 604 which is created by the movement of the first resilient wall portion 607a of the reservoir 607. As such, the pressure in the second chamber C2 will be substantially constant. The two resilient reservoirs 607’, 607” are made from a medical grade elastic silicone material but may in alternative embodiments be made from another biocompatible polymer material, such as polyurethane. Fig. 50 shows and embodiment of a system comprising a motor MO, gear system G and two implantable pumps 460’, 460”. The implantable pumps 40’, 460” described with reference to fig. 50 may be used as a part of a hydraulic operation device for operating any of the hydraulic embodiments of the medical device disclosed herein. The hydraulic pump 604 may be placed in, or in direct connection with a vessel member of the system, or may be placed in a remote unit, for example replacing part of the hydraulic operation device placed in the remote unit described with reference to fig. 27. In the embodiment shown in fig. 50, the force output of the motor MO is connected to a force input of the gear system G. The gear system G is configured to reduce the velocity and increase the force of the movement generated by the motor MO, such that the movement exiting the gear system G at the force output of the gear system G is a mechanical force with a lower velocity and a greater force than the movement entering the force input of the gear system G. Typically, an implantable brushless DC motor, such as the motors provided by Maxon group or Dr. Fritz Faulhaber, typically produces a rotational velocity exceeding 10 000 rpm. For such a motor to be able to mechanically operate any of the hydraulic pumps described herein, a gear system G is needed. In the embodiment shown with reference to fig. 50, the gear system G reduces the rotational velocity 100 times, to about 100 rpm. The force output of the gear system G is mechanically connected to a common rotating shaft 463. The first hydraulic pump comprises a first gerotor pump 460’ and the second hydraulic pump comprises a second gerotor pump 460” . The common rotating shaft 463 is mechanically connected to an inner rotor 461’ of the first gerotor pump 460’ and an inner rotor 461 ” of the second gerotor pump, such that the motor MO propels the first and second gerotor pump 460’460”. A gerotor is a positive displacement pump comprising consists of an inner rotor 461 and an outer rotor 462. The inner rotor 461 has 6 teeth, while the outer rotor has 7 teeth (the importance being that the outer rotor 462 has one tooth more than the inner rotor 461. The axis of the inner rotor 461, which is the rotational center of the common rotating shaft 463, is offset from the rotational center or axis of the outer rotor 462. Both the inner and outer rotors 461, 462 rotate on their respective axes. The geometry of the two rotors 461, 462 partitions the volume between them into 6 different dynamically changing volumes. During the rotation cycle, each of these volumes changes continuously, so any given volume first increases, and then decreases. An increase creates a vacuum. This vacuum creates suction, and hence, this part of the cycle is where the inlet 651a is located. As a volume decreases compression occurs which pumps the fluid though the outlet 65 lb.
In the embodiment shown in fig. 50, the first gerotor pump 460’ is configured to be in fluid connection with a first hydraulic member or hydraulic cuff for pumping hydraulic fluid into the first hydraulic member or hydraulic cuff. The second gerotor pump 460” is configured to be in fluid connection with a second hydraulic member or hydraulic cuff for pumping hydraulic fluid into the second hydraulic member or hydraulic cuff. The inlets 65 la’, 65 la” of the first and second gerotor pumps 460 ’,460” are configured to be connected to a reservoir for holding hydraulic fluid, or in the alternative, the first inlet 65 la’ is configured to be connected to a first implantable reservoir and the second inlet 65 la” is configured to be connected to a second implantable reservoir.
In alternative embodiments, the first and second hydraulic pump mechanically connected to a common rotating shaft could be pump comprising at least one compressible hydraulic reservoir (such as the pump described with reference to fig. 49A), a pump comprising a displaceable wall (such as the pump described with reference to fig. 48), or a peristaltic pump (such as the pump described with reference to figs. 46A and 46B).
The embodiment of two pumps mechanically connected to a common rotating shaft, described with reference to fig. 50, could be implemented in any of the embodiments disclosed herein in which there are more than one operable hydraulic member or cuff, such as in embodiment disclosed with reference to figs. 15A,19A and 19C.
The hydraulic operation device or system could in any of the hydraulic embodiments disclosed herein (such as in the embodiments of figures 3,15A - 15B,16A - 16C,17 and 19A - 19C) further comprise pressure sensor(s) for sensing the pressure in the fluid flowing in the hydraulic system of the hydraulic operation devices, hydraulically adjustable vessel members, including hydraulically adjustable members or cuffs. The sensor(s) could for example be sensors such as the sensors described with reference to figs. 51A - 5 IE. The sensor values could be used as input to an implantable controller which then could be used for controlling an implantable pump and/or an implantable valve connected to the vessel member. It is important to measure pressure in or exerted by the vessel member, as too high pressure risks damaging the blood vessel having the aneurysm or hampering the blood flow to the tissue of the blood vessel, which in the long term could lead to damage of the tissue and in the worst case lead to necrosis. The controller could use a continuous or intermittent pressure signal to compute an average pressure over a time period, such as a period of more than 20 seconds, more than 1 minute, more than 3 minutes, more than 5 minutes or more than 10 minutes, as it is the average pressure over a time period that risks creating low oxygenation in the tissue and thus risks the damaging of the tissue. It may be ok that the pressure on the tissue exceeds the diastolic bold pressure, and even the systolic blood pressure, for a shorter period but not be ok if that period exceeds 20 seconds or 1 minute or 3 minutes or 5 minutes or 10 minutes. It is conceivable that the controller measures the average pressure as the integral of pressure values over a period of time. To act as a withholding force against the expanding aneurysm, the pressure exerted should be somewhere between the systolic and diastolic blood pressure. Preferably more than 5% higher than the diastolic blood pressure and preferably more than 5% lower than the systolic blood pressure.
Fig. 51A shows an embodiment of a pressure sensor 606 which could be implemented in any of the systems shown herein for sensing a pressure in a hydraulic fluid in the system. Pressure is an expression of the force required to stop a fluid from expanding and is stated in terms of force per unit area. The pressure sensor 606 acts as a transducer generating a signal as a function of the pressure imposed. In fig. 51A and 5 IB, a diaphragm is used as a force collector. However, it is equally conceivable that the diaphragm is replaced by e.g. a piston, a bourdon tube, or a bellows acting as force collector.
The pressure sensor 606 comprises a sensor housing 475 which comprises integrated channels. An inlet channel 470 is configured to conduct hydraulic fluid such that the hydraulic fluid is placed in contact with a diaphragm 471. The diaphragm 471 is resilient and could for example be made from a medical grade silicone material which is elastic enough such that the pressure exerted on the diaphragm 471 is transferred to a gel-like substance 473 which in turn presses on a pressure sensing element. The pressure sensing element is thus separated from the hydraulic fluid in the hydraulic operation device by the diaphragm 471. In the embodiment shown in fig. 51 A, the pressure sensing element 472 is a strain gauge which creates an electrical pressure sensor signal which is transferred to a controller by means of a lead 474. The strain gauge could be a resistive, piezoresistive or piezoelectric strain gauge, or an optical strain gauge or a capacitive strain gauge.
A resistive strain gauge uses a pressure sensing element 472 where metal strain gauges are fixated. The resistance through the metal strain gauges is changed with the elongation which is used to create the electrical pressure signal. A piezoresistive strain gauge uses the piezoresistive effect of strain gauges to detect strain due to applied pressure, resistance increasing as pressure deforms the material. Common technology types are Silicon (Monocrystalline), Polysilicon Thin Film, Bonded Metal Foil, Thick Film, Silicon-on-Sapphire and Sputtered Thin Film. A capacitive strain gauge uses the diaphragm 471 to create a variable capacitor to detect strain due to applied pressure as the capacitance decreases as pressure deforms the diaphragm 471. Common technologies use metal, ceramic, and silicon diaphragms. Electromagnetic strain gauges measure the displacement of the diaphragm 471 by means of changes in inductance (reluctance), LVDT, Hall Effect, or by eddy current principle. An optical strain gauge uses the physical change of an optical fiber to detect strain due to applied pressure. A common example of this type utilizes Fiber Bragg Gratings. The strain gauges may be connected to form a Wheatstone bridge circuit to maximize the output of the sensor and to reduce sensitivity to errors.
The pressure sensor, when implemented in any of the hydraulic operation devices shown herein, is ultimately configured to measure the pressure in the medical device which exerts pressure on the stomach wall for the purpose stretching the stomach wall to create a sensation of satiety. When a pressure is exerted on a portion of the stomach wall, the blood flow of that particular portion of the stomach wall is hampered, which creates a risk that the portion suffers from ischemia, which may cause irreversible necrosis of the restricted tissue. By measuring the pressure, the hydraulic pumps or electrically controllable valves of the system can be controlled to create pressure or strain against the stomach wall optimal for stretching the stomach wall, which in many instances is a mediation between the stretching effect while making sure that the stretching does not damage the tissue of the stomach wall.
The tissue wall is oxygenized through the circulatory blood system in which the blood pressure in a normal person is about 120mm Hg during systole and 80mm Hg during diastole. This means that a normal person is capable if oxygenizing tissue against a pressure not exceeding 120mm Hg. 120mm Hg equals 163cm H2O, which means that there is no risk, in a normal person, that tissue will suffer from ischemia as long as the pressure exerted is below 100cm H2O. As a short hampering of the blood flow in the tissue could be acceptable, but a longer could be damaging, the continuous sensing and control of the pressure exerted is important.
Fig. 5 IB shows an alternative embodiment of the pressure sensor, in which the pressure sensor 606 comprises a diaphragm 471 being an integrated part of the reservoir 607 in which the pressure is to be measured. A pressure sensing element 472 is connected to the diaphragm 471, such that the diaphragm 471 separates the pressure sensing element 472 from the hydraulic fluid. The pressure sensing element 472 comprises a strain gauge, for example a strain gauge functioning in accordance with one of the strain gauge principles described above. The strain gauge is connected to a controller by means of a lead 474, such that the measured pressure in the reservoir could be used in the control of the system.
In alternative embodiments, the pressure sensor could be used for measuring the pressure of a gaseous fluid. In this case, the diaphragm is in connection with an enclosed lumen configured to hold a gaseous fluid, and the pressure sensing element is configured to sense the pressure of the gaseous fluid. The enclosed lumen configured to hold a gaseous fluid may then be in connection with a part of the hydraulic system holding the hydraulic fluid, such that the pressure in the hydraulic system can be measured indirectly by measuring the pressure of the gaseous fluid in the enclosed lumen.
Fig. 51C shows an embodiment of a pressure sensor similar to the embodiment shown in fig. 5 IB, with the difference that in the embodiment of fig. 51C, the pressure sensor 606 comprises a first 472’ and second 472” pressure sensing element. The first pressure sensing element 472’ is configured to measure a pressure the implanted hydraulic system, e.g. by measuring the pressure in an implanted fluid reservoir 607 in fluid connection, or indirect fluid connection, with the implantable hydraulic operation device or hydraulic member of the vessel member (e.g. described with reference to fig. 15A and 15B.). The second pressure sensing element 472” is configured to measure the atmospheric pressure. The reservoir 107 comprises an elastic membrane 471 being integrated in the wall of the reservoir 107, and the first pressure sensing element 472’ is configured to measure the pressure in the reservoir 107 on the first, inner, side of the elastic membrane 471 and the second pressure sensing element 472” is configured to measure the atmospheric pressure on the second, outer, side of the elastic membrane 471. The pressure sensor 606 is connected to a controller 300, and the controller 300 is configured to derive an absolute pressure by subtracting the atmospheric pressure from the pressure in the reservoir 607. The controller then controls the pressure in the reservoir 607, and thus indirectly in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member, on the basis of the derived absolute pressure, or in the alternative on the basis of the received first and second input signals.
In the embodiment shown in fig. 51C, the pressure sensor is configured to derive the pressure in the reservoir 607 by measuring the pressure in the reservoir relative to the atmospheric pressure. However, in alternative embodiments it is equally conceivable that the pressure sensor is configured to derive the pressure in the reservoir or in any other part of the hydraulic system by comparing a pressure with vacuum.
Fig. 5 ID shows an embodiment of a pressure sensor similar to the embodiment shown in fig. 5 IB, with the difference that in the embodiment of fig. 5 ID, the implant comprises a second implantable pressure sensor 606” connected to the controller 300. The second implantable pressure sensor 606” is configured to sense the atmospheric pressure by means of a pressure sensing element 472”. The controller 300 is as such configured to receive a second input signal related to the atmospheric pressure from the second implantable pressure sensor 606”, not necessarily placed in direct connection with the reservoir 607. In the same way as in the embodiment described with reference to fig. 51C, the controller 300 is configured to control the pressure in the reservoir 607, and thus indirectly in the hydraulic system / hydraulic operation device, on the basis of a derived absolute pressure, or in the alternative on the basis of the received first and second input signals from the first and second pressure sensors 606’, 606”.
Fig. 5 IE shows an embodiment of a pressure sensor similar to the embodiment shown in fig. 5 ID, with the difference that in the embodiment of fig. 5 IE the system comprises a second pressure sensor 606”’ located external to the body of the patient. In the embodiment shown in fig. 5 IE, the external device 320 is an external controller or communicator (further described with reference to figs. 57A - 57N) comprising a wireless transceiver 328 configured to communicate wirelessly with an implantable transceiver of the implantable controller 300. The second pressure sensor 606’” located external to the body of the patient comprises a pressure sensing element 472” configured to sense the atmospheric pressure and communicate the atmospheric pressure to the implantable controller 300 by means of the wireless communication link (328, 308) between the external device 320 and the implantable controller 300. The external device 320 may communicate the atmospheric pressure each time the patient uses, controls, programs or adjusts the implantable medical device, i.e. a signal related the atmospheric pressure may be sent together with the signal for operating, controlling or programming the medical device. As such, the implantable controller 300 may control the pressure in the reservoir 607, and thus indirectly in the hydraulic system / hydraulic operation device on the basis of a derived absolute pressure, or in the alternative on the basis of the received first and second input signals from the first and second pressure sensors 606’, 606’”, such that differences in atmospheric pressure due to weather or altitude may be considered when setting the suitable pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member. This enables the pressure to be optimized to withhold the expansion of an aneurysm while not damaging tissue by for example hampering the blood flow.
In the alternative, the atmospheric pressure may be measured by means of the pressure sensor 606’ connected to the reservoir, or by means of a pressure sensor connected to the hydraulic system / hydraulic operation device hydraulic member / cuff of the vessel member. The method of measuring the atmospheric pressure comprises releasing the pressure from the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member before the pressure is measured. As no pressure is added to the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member, the atmospheric pressure will be the pressure that is measures. The pressure measured when the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member is without added pressure can be used as a reference value against which the pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member can be measured. This enables both the atmospheric (reference) pressure and the pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member to be measured using the same pressure sensor, which creates a compact and efficient design. The measured reference could also be compared with the atmospheric pressure measured by a second, external pressure sensor 606’”. This comparison/calibration can be used to establish that there is no pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member when the controller has released the pressure. The pressure applied to the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member can be controlled either by controlling the actual pressure, or by controlling the volume of fluid pumped and/or by controlling the cross-sectional distance of the constricted urethra. I.e. if the pressure is continuously calibrated it can be established that a certain fluid level or distance leads to a specific pressure, which could make control of the device easier then control using constant pressure measurement. The controller (a computing unit of the controller) could in one embodiment create an absolute pressure by subtracting the pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member, when substantially no pressure is exerted, from the pressure in the hydraulic system / hydraulic operation device when the pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member has been increased. The operation device could then control the pressure in the hydraulic system / hydraulic operation device / hydraulic member / cuff of the vessel member on the basis of the absolute pressure. In embodiments in which the fluid level or cross-sectional distance of the blood vessel is used as control value, the pressure may be used as a back-up or safety system, e.g. the pressure sensor can be set to give an alarm signal or take a specific action if the pressure increases over a set value (threshold). In all of the described sensor embodiments above, any of the pressure sensors 606 may be a strain gauge-based pressure sensor, such as a piezoresistive or piezoelectric pressure sensor, or an optical pressure sensor, a capacitive pressure sensor, or an electromagnetic pressure sensor.
As described with further reference to figs. 57A - 57N, the controller 300 referenced in any of figures 57A - 57N could be configured to control an electrically operable pump and/or valve to control the pressure in the hydraulic system / hydraulic operation device.
In the following a detailed description of a method and apparatus for electrically stimulating the tissue of the blood vessel and thereby improve the conditions for long term implantation of the vessel member will be given. The electrical electrode arrangement described and the electrical electrodes comprised in the arrangement may be implemented in any of the embodiments of the system described herein for the purpose of exercising the tissue wall which is in contact with the vessel member. The body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body. Exposing tissue to long-term engagement with, or pressure from, an implant may deprive the cells of oxygen and nutrients, which may lead to deterioration of the tissue, atrophy and eventually necrosis. The interaction between the implant and the tissue may also result in fibrosis, in which the implant becomes at least partially encapsulated in fibrous tissue. It is therefore desirable to stimulate or exercise the cells to stimulate blood flow and increase tolerance of the tissue for pressure from the implant.
Muscle tissue is generally formed of muscle cells that are joined together in tissue that can be either striated or smooth, depending on the presence or absence, respectively, of organized, regularly repeated arrangements of myofibrillar contractile proteins called myofilaments. Striated muscle tissue is further classified as either skeletal or cardiac muscle tissue. Skeletal muscle tissue is typically subject to conscious control and anchored by tendons to bone. Cardiac muscle tissue is typically found in the heart and not subject to voluntary control. A third type of muscle tissue is the so-called smooth muscle tissue, which is typically neither striated in structure nor under voluntary control. Smooth muscle tissue can be found within the walls of organs and in for example the stomach wall.
The contraction of the muscle tissue may be activated both through the interaction of the nervous system as well as by hormones. The different muscle tissue types may vary in their response to neurotransmitters and endocrine substances depending on muscle type and the exact location of the muscle.
A nerve is an enclosed bundle of nerve fibers called axons, which are extensions of individual nerve cells or neurons. The axons are electrically excitable, due to maintenance of voltage gradients across their membranes, and provide a common pathway for the electrochemical nerve impulses called action potentials. An action potential is an all-or-nothing electrochemical pulse generated by the axon if the voltage across the membrane changes by a large enough amount over a short interval. The action potentials travel from one neuron to another by crossing a synapse, where the message is converted from electrical to chemical and then back to electrical.
The distal terminations of an axon are called axon terminals and comprise synaptic vesicles storing neurotransmitters. The axonal terminals are specialized to release the neurotransmitters into an interface or junction between the axon and the muscle cell. The released neurotransmitter binds to a receptor on the cell membrane of the muscle cell for a short period of time before it is dissociated and hydrolyzed by an enzyme located in the synapse. This enzyme quickly reduces the stimulus to the muscle, which allows the degree and timing of muscular contraction to be regulated delicately.
The action potential in a normal skeletal muscle cell is similar to the action potential in neurons and is typically about -90 mV. Upon activation, the intrinsic sodium/potassium channel of the cell membrane is opened, causing sodium to rush in and potassium to trickle out. As a result, the cell membrane reverses polarity and its voltage quickly jumps from the resting membrane potential of -90 mV to as high as +75 mV as sodium enters. The muscle action potential lasts roughly 2-4 ms, the absolute refractory period is roughly 1-3 ms, and the conduction velocity along the muscle is roughly 5 m/s. This change in polarity causes in turn the muscle cell to contract.
The contractile activity of smooth muscle cells is typically influenced by multiple inputs such as spontaneous electrical activity, neural and hormonal inputs, local changes in chemical composition, and stretch. This in contrast to the contractile activity of skeletal and cardiac muscle cells, which may rely on a single neural input. Some types of smooth muscle cells are able to generate their own action potentials spontaneously, which usually occur following a pacemaker potential or a slow wave potential. However, the rate and strength of the contractions can be modulated by external input from the autonomic nervous system. Autonomic neurons may comprise a series of axon-like swellings, called varicosities, forming motor units through the smooth muscle tissue. The varicosities comprise vesicles with neurotransmitters for transmitting the signal to the muscle cell.
The muscle cells described above, i.e., the cardiac, skeletal and smooth muscle cells are known to react to external stimuli, such as electrical stimuli applied by electrodes. A distinction can be made between stimulation transmitted by a nerve and direct electrical stimulation of the muscle tissue. In case of stimulation via a nerve, an electrical signal may be provided to the nerve at a location distant from the actual muscle tissue, or at the muscle tissue, depending on the accessibility and extension of the nerve in the body. In case of direct stimulation of the muscle tissue, the electrical signal may be provided to the muscle cells by an electrode arranged in direct or close contact with the cells. However, other tissue such as fibrous tissue and nerves may of course be present at the interface between the electrode and the muscle tissue, which may result in the other tissue being subject to the electrical stimulation as well. In the context of the present application, the electrical stimulation discussed in connection with the various aspects and embodiments may be provided to the tissue in direct or indirect contact with the medical device. Preferably, the electrical stimulation is provided by one or several electrode elements arranged at the interface or contact surface between the medical device and the tissue. Thus, the electrical stimulation may, in terms of the present disclosure, be considered as a direct stimulation of the tissue. Particularly when contrasted to stimulation transmitted over a distance by a nerve, which may be referred to as an indirect stimulation or nerve stimulation.
Hence, an electrode arrangement comprising one or several electrode elements may be arranged in, partly in, on, or in close vicinity of the tissue that is to be exercised by means of an electrical signal. Preferably, the electrode may be arranged to transmit the electrical signal to the portions of the tissue that is affected, or risks to be affected, by mechanical forces exerted by the medical implant. Thus, the electrode element may be considered to be arranged between the implanted device and the tissue against which the device is arranged to rest when implanted.
During operation of the medical device, or the electrode arrangement, the electric signal may cause the muscle cells to contract and relax repeatedly. This action of the cells may be referred to as exercise and may have a positive impact in terms of preventing deterioration and damage of the tissue. Further, the exercise may help increasing tolerance of the tissue for pressure and mechanical forces generated by the medical device.
The interaction between the implanted electrode element and the tissue of the stomach wall is to a large extent determined by the properties at the junction between the tissue and the electrode element. The active electrically conducting surface of the electrode element (in the following referred to as “metal”, even though other materials is equally conceivable) can either be uncoated resulting in a metal-tissue interface, or insulated with some type of dielectric material. The uncoated metal surface of the electrode element may also be referred to as a bare electrode. The interface between the electrode element and the tissue may influence the behavior of the electrode element, since the electrical interaction with the tissue is transmitted via this interface. In the biological medium surrounding the electrode element, such as the actual tissue and any electrolyte that may be present in the junction, the current is carried by charged ions, while in the material of the electrode element the current is carried by electrons. Thus, in order for a continuous current to flow, there needs to be some type of mechanism to transfer charge between these two carriers.
In some examples, the electrode element may be a bare electrode wherein the metal may be exposed to the surrounding biological medium when implanted in, or at the muscle tissue that is to be stimulated. In this case there may be a charge transfer at a metal-electrolyte interface between the electrode element and the tissue. Due to the natural strive for thermodynamic equilibrium between the metal and the electrolyte, a voltage may be established across the interface which in turn may cause an attraction and ordering of ions from the electrolyte. This layer of charged ions at the metal surface may be referred to as a “double layer” and may physically account for some of the electrode capacitance.
Hence, both capacitive faradaic processes may take place at the electrode element. In a faradaic process, a transfer of charged particles across the metal-electrolyte interface may be considered as the predominant current transfer mechanism. Thus, in a faradaic process, after applying a constant current, the electrode charge, voltage and composition tend to go to constant values. Instead, in a capacitive (non-faradaic) process charge is progressively stored at the metal surface and the current transfer is generally limited to the amount which can be passed by charging the interface.
In some examples, the electrode element may comprise a bare electrode portion, i.e., an electrode having an uncoated surface portion facing the tissue such that a conductor-tissue interface is provided between the electrode element and the tissue when the electrode element is implanted. This allows for the electric signal to be transmitted to the tissue by means of a predominantly faradaic charge transfer process. A bare electrode may be advantageous from a power consumption perspective, since a faradaic process tend to be more efficient than a capacitive charge transfer process. Hence, a bare electrode may be used to increase the current transferred to the tissue for a given power consumption.
In some examples, the electrode element may comprise a portion that is at least partly covered by a dielectric material so as to form a dielectric-tissue interface with the muscle tissue when the electrode is implanted. This type of electrode element allows for a predominantly capacitive, or non-faradaic, transfer of the electric signal to the muscle tissue. This may be advantageous over the predominantly faradaic process associated with bare electrodes, since faradaic charge transfer may be associated with several problems. Example of problems associated with faradaic charge transfer include undesirable chemical reactions such as metal oxidation, electrolysis of water, oxidation of saline, and oxidation of organics. Electrolysis of water may be damaging since it produces gases. Oxidation of saline can produce many different compounds, some of which are toxic. Oxidation of the metal may release metal ions and salts into the tissue which may be dangerous. Finally, oxidation of organics in a situation with an electrode element directly stimulating tissue may generate chemical products that are toxic.
These problems may be alleviated if the charge transfer by faradaic mechanisms is reduced, which may be achieved by using an electrode at least partly covered by a dielectric material. Preferably, the dielectric material is chosen to have as high capacitance as possible, restricting the currents flowing through the interface to a predominantly capacitive nature.
Several types of electrode elements can be combined with the present disclosure. The electrode element can for example be a plate electrode, comprising a plate-shaped active part forming the interface with the tissue. In other examples, the electrode may be a wire electrode, formed of a conducting wire that can be brought in electrical contact with the tissue. Further examples may include needle- or pin-shaped electrodes, having a point at the end which can be attached to or inserted in the muscle tissue. The electrodes may for example be encased in epoxy for electrical isolation and protection and comprise gold wires or contact pads for contacting the muscle tissue. Some of these examples of electrodes, methods of stimulating using electrodes, and how the electrode arrangements can be arranged in connection with an implanted vessel member will be discussed below with reference to figs. 52 - 56.
Fig. 52 shows an embodiment of the implantable system for handling an aneurysm in a blood vessel 20 of a patient. The system comprises a vessel member 100 positioned on the abdominal portion of the aorta 20, such that the vessel member 100 partially encloses the aorta in a region of the aneurysm 50. The vessel member 100 comprises the features of the vessel member disclosed with reference to fig. 5B, but further comprises an electrode arrangement comprising two electrodes El, E2 for electrically stimulating the tissue of the blood vessel 20 for exercising the tissue of the blood vessel 20 to improve the conditions for long term implantation of the vessel member 100 in connection with the blood vessel 20. In the embodiment of fig. 52, the two electrodes El, E2 are arranged on the insides of the vessel member 100 and thus placed in abutment and in electrical connection with the tissue of the blood vessel 20. Each of the two electrode elements El, E2 are connected to a stimulation controller 350 by means of electrical conduits 652. The stimulation controller 350 is configured to be operably connected to the electrode arrangement for controlling the electrical stimulation of the tissue. In the embodiment shown in fig. 52, the stimulation controller 350 is configured to control the electrical stimulation such that the tissue is stimulated by a series of electrical pulses. In the embodiment shown in fig. 52, the pulses comprise a pulse of a first polarity followed by a pulse of a second, reversed polarity, and the pulsed electrical stimulation signal generated comprises a pulse frequency of 0.01-150 Hz. In the embodiment shown in fig. 52, the electrical stimulation signal comprises a pulse duration of 0.01-100 ms and a pulse amplitude of 1-15 mA. More specifically, in the embodiment of fig. 52, the electrical stimulation signal comprises a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms and a pulse amplitude of 3-10 mA. Further, in the embodiment of fig. 52, the electrical stimulation signal comprises a build-up period of 0.01-2 s in which the amplitude is gradually increasing, a stimulation period of 1-60 s, and a stimulation pause of 0.01-60 s, wherein the electrical signal comprises a pulse frequency of 1-50 Hz and a pulse duration of 0.1-10 ms.
The stimulation controller 350 of fig. 52 is integrated in an implantable controller, such as the implantable controller described with reference to figs. 57A - 57N, and the stimulation controller 350 may be configured to receive input from a wireless remote control, directly or via a receiver of the implantable controller, for controlling the stimulation or for programming a stimulation routine for exercising the tissue to improve the conditions for long term implantation of the vessel member 100. The programming of a stimulation routine could for example be the programming of the frequency of the stimulation, or the current and/or voltage of the stimulation. In the embodiment shown in fig. 52, the implantable system further comprises an implantable sensor 606 configured to sense actions potentials generated by pacemaker cells of the tissue of the blood vessel 20. The implantable sensor 606 is connected to the vessel member 100 and connected to the stimulation controller 350 by means of a sensor lead 474. The stimulation controller 350 is configured to control the electrical simulation based at least partly on the sensed action potentials and is configured to generate electrical pulses amplifying the sensed action potentials. The implantable sensor may be implemented in any of the embodiments of vessel members 100 for controlling the electrical stimulation by the electrode elements, which also may be implemented in any of the embodiments of systems described herein.
Fig. 53A is an example of a bipolar electrode arrangement, comprising a first and a second electrode element El, E2 that can be connected to different electrical potentials. Thus, the first electrode element El can be operated as an anode and the second electrode element E2 can be operated as a cathode. The electrode elements El, E2 may be attached directly to an outer surface of a member of the medical device, such as disclosed with reference to fig. 52. In some examples the electrode elements El, E2 may be arranged on a support, such as a flexible patch, which may be configured to be attached to the vessel member. The electrode arrangement 353 can be arranged between the vessel member and the tissue (such as disclosed with reference to fig. 52) and may in some examples be provided as a separate, physically distinct item and in other examples be integrated in the vessel member. The electrode arrangement 353 may comprise one or several contact pads for increasing the contact surface between the electrode and the tissue when implanted. During operation, the electrical signal may be delivered to the muscle tissue by means of the first and second electrode elements El, E2 so as to stimulate contraction of the muscle cells.
Fig. 53B is another example of an electrode arrangement 353, which in the present example may be a unipolar electrode element El. The electrode element El may for example be operated as a cathode when implanted. The electrode element El may be formed of a flat, coiled wire for increasing the contact surface between the electrode element El and the tissue. Further, the coiled configuration allows for a certain mechanical flexibility of the electrode element El such that it can follow the muscle tissue during contraction and relaxation.
Fig. 53C illustrates the end portion of a needle- or pin-shaped electrode arrangement 353, wherein the active portion of the electrode element El is provided as a bare electrode surface 354 at the end of the electrode element El, protruding from an insulation 355 covering the rest of the electrode element El. Thus, when implanted at or in the muscle tissue, the active, bare electrode surface 354 of the electrode element El may form a metal-tissue interface with the muscle tissue, wherein the interface may surround the end portion of the electrode element El so as to provide a relatively large contact surface. The present example is advantageous in that it can be inserted into the tissue, thereby allowing for a selective stimulation at a certain depth of the tissue. Fig. 53D shows a similar electrode element as the one in figure 53C, with the difference that the present electrode element El comprises an active portion that is covered by a dielectric material 356 so as to protect the electrode material from deterioration and to facilitate capacitive current transfer. The dielectric material 356 may for example be electrochemically deposited tantalum oxide, which allows the electrical charge to pass through the interface but reduces the risk for electrode corrosion, gas formation and metabolite reactions.
It will be appreciated that both faradaic and capacitive mechanisms may be present at the same time, irrespectively of the type of electrode used. Thus, capacitive charge transfer may be present also for a bare electrode forming a metal-tissue interface, and faradaic charge transfer may be present also for a coated electrode forming a dielectric-tissue interface. It has been found that the faradaic portion of the current delivered to the muscle tissue can be reduced or even eliminated by reducing the duration of the pulses of the electric signal. Reducing the pulse duration has turned out to be an efficient way of increasing the portion of the signal which can be passed through the interface as a capacitive current, rather than by a faradaic current. As a result, shorter pulses may produce less electrode and tissue damage.
The capacitive portion of the current may further be increased, relative to the faradaic portion, by reducing the amplitude of the current pulses of the electrical signal. Reducing the amplitude may reduce or suppress the chemical reactions at the interface between the electrode and the tissue, thereby reducing potential damage that may be caused by compounds and ions generated by such reactions.
In one example, the electrical stimulation may be controlled in such a manner that a positive pulse of the electrical signal is followed by a negative pulse (or, put differently, a pulse of a first polarity being followed by a pulse of a second, reversed polarity), preferably of the same amplitude and/or duration. Advantageously, the subsequent negative (or reversed) pulse may be used to reverse or at least moderate chemical reactions or changes taking place in the interface in response to the first, positive pulse. By generating a reversed pulse, the risk of deterioration of the electrode and/or the tissue at the interface between the electrode and the muscle tissue may be reduced.
Fig. 54 shows an example of a pulsed electrical signal to be applied to an electrode for electrically stimulating muscle tissue via an electrode-tissue interface as discussed above. The electrical signal may be generated by a stimulation controller arranged outside the body or implanted in the body (as described with reference to fig. 52). The stimulation controller may be operatively connected to the electrode element by means of a lead, and the electrical signal shown in the present figure may either reflect the signal as generated at the stimulation controller, or the signal as delivered to the electrode element at the electrode-tissue interface. The characteristics of the electrical signal may be selected and varied determined on the electrical and properties at the electrode-tissue interface and on the actual response of the tissue. The electrical stimulation delivered to the muscle cells may depend on several factors, such as the configuration and placement of the electrode element at the tissue, the presence of fibrous material at the interface, the composition of the electrolyte in the interface, accumulation of non-conducting material on the electrode surfaces, etcetera. It is therefore suggested that the characteristics of the electric signal, as shown in the present figure, be selected and varied based on an observed or estimated response from the stimulated tissue.
In the present example, the electrical signal is a pulsed signal comprising square waves PU1, PU2, PU3, PU4. However, other shapes of the pulses may be employed as well. The pulse signal may be periodic, as shown, or may be intermittent (i.e., multiple series of pulses separated by periods of no pulses). The pulses may have an amplitude A, which may be measured in volts, ampere or the like. Each of the pulses of the signal may have a pulse width D. Likewise, if the signal is periodic, the pulse signal may have a period F that corresponds to a frequency of the signal. Further, the pulses may be either positive or negative in relation to a reference.
The pulse frequency may for example lie within the range of 0.01-150 hertz. More specifically, the pulse frequency may he within at least one of the ranges of 0.1-1 Hz, 1-10 Hz, 10- 50 Hz and 50-150 Hz. It has been observed that relatively low pulse frequencies may be employed to imitate or enhance the slow wave potential associated with pacemaker cells of the smooth muscle tissue. Thus, it may be advantageous to use relatively low pulse frequencies, such as 0.01- 0.1 Hz or frequencies below 1 Hz or a few Hz for such applications.
The pulse duration may for example lie within the range of 0.01-100 milliseconds, such as 0.1-20 milliseconds (ms), and preferably such as 1-5 ms. The natural muscle action potential has in some studies been observed to last about 2-4 ms, so it may be advantageous to use a pulse duration imitating that range.
The amplitude may for example lie within the range of 1-15 milliamperes (mA), such as 0.5-5 mA in which range a particularly good muscle contraction response has been observed in some studies.
In a preferred, specific example the electrical stimulation may hence be performed using a pulsed signal having a pulse frequency of 10 Hz, a pulse duration of 3 ms and an amplitude of 3 mA.
Fig. 55 shows an example of a pulsed signal, comprising build-up period XI, in which the amplitude is gradually increasing, a stimulation period X2 during which the muscle tissue is exposed to a contracting stimulation signal, a ramp down period X3 in which the amplitude is gradually decreasing, and a stimulation pause X4 before a new build-up period is initiated. The build-up period may for example be 0.01-2 seconds, the stimulation period 1-60 seconds, the rampdown period 0.01-2 seconds, and the stimulation pause 0.01-60 seconds. The pulse frequency may for example be 1-50 Hz, the pulse duration 0.1-10 milliseconds and the amplitude during the stimulation period be 1-15 milliampere. The stimulation of skeletal muscle tissue may for example be performed using a frequency of 50 Hz and pulses having a duration of 100 ps. The current amplitude may be 1, 2.5, 7.5 or 10 mA. In particular, a desired muscle contraction response has been experimentally observed within a range of 0.5 to 5.0 mA. In the present example, a coiled electrode may be used as a cathode. Another example design is a multi-stranded wire arranged in a helical design. They can be imbricated in the tissue wall, such as the wall of a blood vessel, and can be stimulated in any desired pattern. The stimulus parameters may for example be biphasic pulses, 10 to 40 Hz, lasting 0.1 to 5 ms, with a current density of 3 to 5 mA/cm2.
Fig. 56 is a schematic outline of a system for electrically stimulating or exercising muscle cells to increase tolerance of the tissue for pressure from the vessel member. The system may be used in combination with the vessel members and may in some examples be comprised in such a vessel member and/or in a remote unit. The system comprises an electrode arrangement 353 which may be similarly configured as the electrode arrangements/electrode elements discussed above in connection with the previous examples, an energy storage unit 40 for providing the electrical energy required for generating the electrical signal, and a stimulation controller 350 controlling the generation of the electrical signal.
The electrode arrangement, which may comprise one or several electrode elements, such as a bare electrode or an electrode at least partly covered by a dielectric material, may be configured to be implanted in the muscle tissue to be stimulated, or to engage the muscle, so as to form an electrode-tissue interface through which the stimulating signal may be transferred. Alternatively, or additionally, the electrode element may be arranged in close vicinity to the muscle tissue such that an electrical coupling between the electrode element and the muscle tissue may be established. This may for example be the case when other tissue, such as connective tissue, is present between the electrode and the tissue.
The electrode may be electrically connected to the energy storage unit 40, for example by means of a wiring / lead, such that the electrical signal may be transferred to the electrode-tissue interface. In some examples, the electrode may be integrated with or attached to the vessel member, such that the electrode when implanted in the patient is arranged at the interface between the members and the muscle tissue. The electrode can thereby be used for exercising the tissue that is mechanically affected by the vessel member.
The energy storage unit 40 may for example be of a non-rechargeable type, such as a primary cell, or of a rechargeable type, such as a secondary cell. The energy storage unit 40 may be rechargeable by energy transmitted from outside the body, from an external energy storage unit, or be replaced by surgery. Further, the electrode arrangement 353 may be operably connected to a stimulation controller 353, which may comprise an electrical pulse generator, for generating the electrical pulse. The stimulation controller 350 may be integrated with the energy storage unit 40 or provided as a separate, physically distinct unit which may be configured to be implanted in the body or operate from the outside of the body. In case of the latter, is may be advantageous to allow the external control unit to communicate wirelessly with the stimulation controller for example by means of a communication unit of a more general controller (for example described with reference to figs. 57 A - 57E).
The system may according to some examples comprise a sensor 606 that is configured to sense a physical parameter of the body and/or the medical device. The sensor 606 may for example be employed to sense or detect a bodily response to the electrical stimulation, such as for example a contraction of the stimulated tissue. In an example, the sensor 606 may be configured to sense action potentials that are being sent to the tissue. The action potentials may for example be generated by pacemaker cells of the muscle tissue, which may be registered by the sensor 606 and transmitted to the stimulation controller 350. The stimulation controller 350 may use the received signal when controlling the energy storage unit 40, such that the generated electrical signal amplifies the sensed action potentials.
The function and features of the controller comprised in the system (such as comprised in the vessel member of the system, connected to the vessel member or comprised in a remote unit) for controlling the system will now described with reference to figures 57A - 57N. The features of the controller described with reference to figs. 57A - 57N may be implemented and combined with any of the embodiments of the system and vessel members (with and without remote units) disclosed herein. The features may for example be implemented in the controllers (300) shown and described with reference to figs. 17, 25B - 28C, 33, 44, 48, 49A - 49H, 51C - 5 IE and 57A - 57N. Any controller 300 may comprise an internal computing unit, also called a processor or processing unit, and it may comprise a communication unit and implement methods for communication, including verification, authentication and encryption of data, as described in the following.
The controller 300 may comprise a collection of communication related sub-units such as a wired transceiver, a wireless transceiver, energy storage unit, an energy receiver, a computing unit, a memory, or a feedback unit. The sub-units of the controller may cooperate with each other or operate independently with different purposes. The sub-units of the controller may inherit the prefix “internal”. This is to distinguish these sub-units from the sub-units of the external devices as similar sub-units may be present for both the implanted controller and the external devices. The sub-units of the external devices may similarly inherit the prefix “external”.
A wireless transceiver may comprise both a wireless transmitter and a wireless receiver. The wireless transceiver may also comprise a first wireless transceiver and a second wireless transceiver. In this case, the wireless transceiver may be part of a first communication system (using the first wireless transceiver) and a second communication system (using the second wireless transceiver).
In some embodiments, two communication systems may be implemented using a single wireless transceiver in e.g. the implant and a single wireless transceiver in e.g. an external device (i.e. one antenna at the implant and one antenna at the external device), but where for example the network protocol used for data transmission from the external device to the implant is different from the network protocol used for data transmission from the implant to the external device, thus achieving two separate communication systems.
Alternatively, the wireless transceiver may be referred to as either a wireless transmitter or a wireless receiver as not all embodiments of secure wireless communication discussed herein require two-way communication capability of the wireless transceiver. The wireless transceiver may transmit or receive wireless communication via wireless connections. The wireless transceiver may connect to both the implant and to external devices, i.e. devices not implanted in the patient.
The wireless connections may be based on radio frequency identification (RFID), near field charge (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The wireless connections may further be based on mobile telecommunication regimes such as 1G, 2G, 3G, 4G, or 5G. The wireless connections may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), or quadrature amplitude modulation (QAM). The wireless connection may further feature technologies such as time-division multiple access (TDMA), frequency-division multiple access (FDMA), or codedivision multiple access (CDMA). The wireless connection may also be based on infra-red (IR) communication. The wireless connection may feature radio frequencies in the high frequency band (HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF) as well as essentially any other applicable band for electromagnetic wave communication. The wireless connection may also be based on ultrasound communication to name at least one example that does not rely on electromagnetic waves.
A wired transceiver may comprise both a wired transmitter and a wired receiver. The wording wired transceiver aims to distinguish between it and the wireless transceiver. It may generally be considered a conductive transceiver. The wired transceiver may transmit or receive conductive communication via conductive connections. Conductive connections may alternatively be referred to as electrical connections or as wired connections. The wording wired however, does not imply there needs to be a physical wire for conducting the communication. The body tissue of the patient may be considered as the wire. Conductive connection may use the body of the patient as a conductor. Conductive connections may still use ohmic conductors such as metals to at least some extent, and more specifically at the interface between the wired transceiver and the chosen conductor.
Communication, conductive or wireless may be understood as digital or analogue. In analogue communication, the message signal is in analogue form i.e., a continuous time signal. In digital communication, usually digital data i.e., discrete time signals containing information is transmitted.
The controller may comprise a sensation generator. A sensation generator is a device or unit that generates a sensation. The sensation generated may be configured to be experienceable by the patient such that the patient may take actions to authenticate a device, connection or communication. The sensation generator may be configured to generate a single sensation or a plurality of sensation components. The sensation or sensation components may comprise a vibration (e.g. a fixed frequency mechanical vibration), a sound (e.g. a superposition of fixed frequency mechanical vibrations), a photonic signal (e.g. a non-visible light pulse such as an infrared pulse), a light signal (e.g. a visual light pulse), an electric signal (e.g. an electrical current pulse) or a heat signal (e.g. a thermal pulse). The sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm.
The sensations generated by the sensation generator may be configured to be experienceable by a sensory function or a sense of the patient from the list of tactile, pressure, pain, heat, cold, taste, smell, sight, and hearing. Sensations may be generated of varying power or force as to adapt to sensory variations in the patient. Power or force may be increased gradually until the patient is able to experience the sensation. Variations in power or force may be controlled via feedback. Sensation strength or force may be configured to stay within safety margins. The sensation generator may be connected to the implant. The sensation generator may be comprised within the implant or be a separate unit.
A motor, e.g. of the active device or unit of the implant, for controlling a physical function in the body of the patient may provide a secondary function as a sensation generator, generating a vibration or sound. Generation of vibrations or sounds of the motor MOay be achieved by operating the motor at specific frequencies. When functioning as to generate a sensation the motor MOay operate outside of its normal ranges for frequency controlling a physical function in the body. The power or force of the motor when operating to generate a sensation may also vary from its normal ranges for controlling a physical function in the body. The motor for use as an active device and a sensation generator could for example be an implantable brushless DC motor with integrated gear box, such as the motors provided by Maxon group or Dr. Fritz Faulhaber.
An external device is a device which is external to the patient in which the implant is implanted in. The external device may be also be enumerated (first, second, third, etc.) to separate different external devices from each other. Two or more external devices may be connected by means of a wired or wireless communication as described above, for example through IP (internet protocol), or a local area network (LAN). The wired or wireless communication may take place using a standard network protocol such as any suitable IP protocol (IPv4, IPv6) or Wireless Local Area Network (IEEE 802.11), Bluetooth, NFC, RFID etc. The wired or wireless communication may take place using a proprietary network protocol. Any external device may also be in communication with the implant using wired or wireless communication according to the above. Communication with implanted devices may be thus accomplished with a wired connection or with wireless radiofrequency (RF) telemetry. Other methods of wireless communication may be used to communicate with implants, including optical and ultrasound. Alternatively, the concept of intrabody communication may be used for wireless communication, which uses the conductive properties of the body to transmit signals, i.e. conductive (capacitive or galvanic) communication with the implant. Means for conductive communication between an external device and an implant may also be called “electrical connection” between an external device and an implant. The conductive communication may be achieved by placing a conductive member of the external device in contact with the skin of the patient. By doing this, the external device and/or the implant may assure that it is in direct electrical connection with the other device. The concept relies on using the inherent conductive or electrical properties of a human body. Signals may preferably be configured to affect the body or body functions minimally. For conductive communication this may mean using low currents. A current may flow from an external device to an implant or vice versa. Also, for conductive communication, each device may have a transceiver portion for transmitting or receiving the current. These may comprise amplifiers for amplifying at least the received current. The current may contain or carry a signal which may carry e.g. an authentication input, implant operation instructions, or information pertaining to the operation of the implant.
Alternatively, conductive communication may be referred to as electrical or ohmic or resistive communication.
The conductive member may be an integrated part of the external device (e.g. in the surface of a smartwatch that is intended to be in contact with the wrist of the person wearing it), or it may be a separate device which can be connected to the external device using a conductive interrace such as the charging port or the headphone port of a smartphone.
A conductive member may be considered any device or structure set up for data communication with the implant via electric conductive body tissue. The data communication to the implant may be achieved by e.g. current pulses transmitted from the conductive member through the body of the patient to be received by a receiver at the implant. Any suitable coding scheme known in the art may be employed. The conductive member may comprise an energy storage unit such as a battery or receive energy from e.g. a connected external device.
The term conductive interface is representing any suitable interface configured for data exchange between the conductive member and the external device. The conductive member may in an alternative configuration receive and transmit data to the external device through a radio interface, NFC, and the like.
An external device may act as a relay for communication between an implant and a remote device, such as e.g. second, third, or other external devices. Generally, the methods of relaying communication via an external device may be preferable for a large number of reasons. The transmission capabilities of the implant may be reduced, reducing its technical complexity, physical dimensions, and medical effects on the patient in which the implant is implanted. Communication may also be more efficient as direct communication, i.e. without a relaying device, with an implant from a remote device may require higher energy transmissions to account for different mediums and different rates of attenuation for different communication means. Remote communication with lower transmission energy may also increase the security of the communication as the spatial area or volume where the communication may be at all noticeable may be made smaller. Utilizing such a relay system further enables the use of different communication means for communication with the implant and communication with remote devices that are more optimized for their respective mediums.
An external device may be any device having processing power or a processor to perform the methods and functions needed to provide safe operation of the implant and provide the patient or other stakeholders (caregiver, spouse, employer etc.) with information and feedback from the implant. Feedback parameters could include battery status, energy level at the controller, the fluid level of the hydraulic restriction device, number of operations that the restriction device has performed, properties, version number etc. relating to functionality of the implantable system. The external device may for example be a handset such as a smartphone, smartwatch, tablet etc. handled by the patient or other stakeholders. The external device may be a server or personal computer handled by the patient or other stakeholders. The external device may be cloud based or a virtual machine. In the drawings, the external device handled by the patient is often shown as a smart watch, or a device adapted to be worn by the patient at the wrist of the patient. This is merely by way of example and any other type of external device, depending on the context, is equally applicable.
Several external devices may exist such as a second external device, a third external device, or another external device. The above listed external devices may e.g. be available to and controllable by a patient, in which an implant is implanted, a caregiver of the patient, a healthcare professional of the patient, a trusted relative of the patient, an employer or professional superior of the patient, a supplier or producer of the implant or its related features. By controlling the external devices may provide options for e.g. controlling or safeguarding a function of the implant, monitoring the function of the implant, monitoring parameters of the patient, updating or amending software of the implant etc.
An external device under control by a supplier or producer of the implant may be connected to a database comprising data pertaining to control program updates and/or instructions. Such database may be regularly updated to provide new or improved functionality of the implant, or to mitigate for previously undetected flaws of the implant. When an update of a control program of an implant is scheduled, the updated control program may be transmitted from the database in a push mode and optionally routed via one or more further external devices before received by the implanted controller. In another embodiment, the update is received from the database by request from e.g. an external device under control by the patient having the implant implanted in his/her body, a pull mode. The external device may require authentication to be operated in communication with other external devices or the implant. Passwords, multi-factor authentication, biometric identification (fingerprint, iris scanner, facial recognition, etc.) or any other way of authentication may be employed.
The external device may have a user interface (UI) for receiving input and displaying information/feedback from/to a user. The UI may be a graphical UI (GUI), a voice command interface, speaker, vibrators, lamps, etc.
The communication between external devices, or between an external device and the implant may be encrypted. Any suitable type of encryption may be employed such as symmetric or asymmetric encryption. The encryption may be a single key encryption or a multi-key encryption. In multi-key encryption, several keys are required to decrypt encrypted data. The several keys may be called first key, second key, third key, etc. or first part of a key, second part of the key, third part of the key, etc. The several keys are then combined in any suitable way (depending on the encryption method and use case) to derive a combined key which may be used for decryption. In some cases, deriving a combined key is intended to mean that each key is used one by one to decrypt data, and that the decrypted data is achieved when using the final key.
In other cases, the combination of the several key result in one “master key” which will decrypt the data. In other words, it is a form of secret sharing, where a secret is divided into parts, giving each participant (external device(s), internal device) its own unique part. To reconstruct the original message (decrypt), a minimum number of parts (keys) is required. In a threshold scheme this number is less than the total number of parts (e.g. the key at the implant and the key from one of the two external device are needed to decrypt the data). In other embodiments, all keys are needed to reconstruct the original secret, to achieve the combined key which may decrypt the data.
In should be noted that it is not necessary that the generator of a key for decryption is the unit that in the end sends the key to another unit to be used at that unit. In some cases, the generator of a key is merely a facilitator of encryption/decryption, and the working in behalf of another device/user.
A verification unit may comprise any suitable means for verifying or authenticating the use (i.e. user authentication) of a unit comprising or connected to the verification unit, e.g. the external device. For example, a verification unit may comprise or be connected to an interface (UI, GUI) for receiving authentication input from a user. The verification unit may comprise a communication interface for receiving authentication data from a device (separate from the external device) connected to the device comprising the verification unit. Authentication input/data may comprise a code, a key, biometric data based on any suitable techniques such as fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison, etc. The verification/authentication may be provided using third party applications, installed at or in connection with the verification unit. The verification unit may be used as one part of a two-part authentication procedure. The other part may e.g. comprise conductive communication authentication, sensation authentication, or parameter authentication.
The verification unit may comprise a card reader for reading a smart card. A smart card is a secure microcontroller that is typically used for generating, storing and operating on cryptographic keys. Smart card authentication provides users with smart card devices for the purpose of authentication. Users connect their smart card to the verification unit. Software on the verification unit interacts with the keys material and other secrets stored on the smart card to authenticate the user. In order for the smart card to operate, a user may need to unlock it with a user-PIN. Smart cards are considered a very strong form of authentication because cryptographic keys and other secrets stored on the card are very well protected both physically and logically, and are therefore hard to steal.
The verification unit may comprise a personal e-ID that is comparable to, for example, passport and driving license. The e-ID system comprises is a security software installed at the verification unit, and a e-ID which is downloaded from a web site of a trusted provided or provided via a smart card from the trusted provider.
The verification unit may comprise software for SMS-based two-factor authentication. Any other two-factor authentication systems may be used. Two-factor authentication requires two things to get authorized: something you know (your password, code, etc.) and something you have (an additional security code from your mobile device (e.g. a SMS, or a e-ID) or a physical token such as a smart card).
Other types of verification/user authentication may be employed. For example, a verification unit which communicate with an external device using visible light instead of wired communication or wireless communication using radio. A light source of the verification unit may transmit (e.g. by flashing in different patterns) secret keys or similar to the external device which uses the received data to verify the user, decrypt data or by any other means perform authentication. Light is easier to block and hide from an eavesdropping adversary than radio waves, which thus provides an advantage in this context. In similar embodiments, electromagnetic radiation is used instead of visible light for transmitting verification data to the external device.
Parameters relating to functionality of the implant may comprise for example a status indicator of the implant such as battery level, version of control program, properties of the implant, status of a motor of the implant, etc.
Data comprising operating instructions sent to the implant may comprise a new or updated control program, parameters relating to specific configurations of the implant, etc. Such data may for example comprise instructions how to operate the body engaging portion of the implantable medical device, instructions to collect patient data, instructions to transmit feedback, etc. The expressions “confirming the electrical connection between an implant and an external device” or “authenticating a connection between an implant and an external device”, or similar expressions, are intended to encompass methods and processes for ensuring or be reasonably sure that the connection has not been compromised. Due to weaknesses in the wireless communication protocols, it is a simple task for a device to “listen” to the data and grab sensitive information, e.g. personal data regarding the patient sent from the implant, or even to try to compromise (hack) the implant by sending malicious commands or data to the implant. Encryption may not always be enough as a security measure (encryption schemes may be predictable), and other means of confirming or authenticating the external device being connected to the implant may be needed.
The expression “network protocol” is intended to encompass communication protocols used in computer networks, a communication protocol is a system of rules that allow two or more entities of a communications system to transmit information via any kind of variation of a physical quantity. The protocol defines the rules, syntax, semantics and synchronization of communication and possible error recovery methods. Protocols may be implemented by hardware, software, or a combination of both. Communication protocols have to be agreed upon by the parties involved. In this field, the term “standard” and “proprietary” is well defined. A communication protocol may be developed into a protocol standard by getting the approval of a standards organization. To get the approval the paper draft needs to enter and successfully complete the standardization process. When this is done, the network protocol can be referred to a “standard network protocol” or a “standard communication protocol”. Standard protocols are agreed and accepted by whole industry. Standard protocols are not vendor specific. Standard protocols are often, as mentioned above, developed by collaborative effort of experts from different organizations.
Proprietary network protocols, on the other hand, are usually developed by a single company for the devices (or Operating System) which they manufacture. A proprietary network protocol is a communications protocol owned by a single organization or individual. Specifications for proprietary protocols may or may not be published, and implementations are not freely distributed. Consequently, any device may not communicate with another device using a proprietary network protocol, without having the license to use the proprietary network protocol, and knowledge of the specifications for proprietary protocol. Ownership by a single organization thus gives the owner the ability to place restrictions on the use of the protocol and to change the protocol unilaterally.
A control program is intended to define any software used for controlling the implant. Such software may comprise an operating system of the implant, of parts of an operating system or an application running on the implant such as software controlling a specific functionality of the implant (e.g. the active unit of the implant, feedback functionality of the implant, a transceiver of the implant, encoding/decoding functionality of the implant, etc.). The control program may thus control the medical function of the implant, for example the pressure applied by a member or the power of the electrical stimulation device. Alternatively or additionally, the control program may control internal hardware functionality of the implant such as energy usage, transceiver functionality, etc.
The systems and methods disclosed hereinabove may be implemented as software, firmware, hardware or a combination thereof. In a hardware implementation, the division of tasks between functional units referred to in the above description does not necessarily correspond to the division into physical units; to the contrary, one physical component may have multiple functionalities, and one task may be carried out by several physical components in cooperation. Certain components or all components may be implemented as software executed by a digital signal processor or microprocessor or be implemented as hardware or as an application-specific integrated circuit. Such software may be distributed on computer readable media, which may comprise computer storage media (or non-transitory media) and communication media (or transitory media). As is well known to a person skilled in the art, the term computer storage media includes both volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information, and which can be accessed by a computer. Further, it is well known to the skilled person that communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media.
A controller 300 for controlling the medical device according to any of the embodiments herein and for communicating with devices external to the body of the patient and/or implantable sensors will now be described with reference to figures 57A - 57C. Figure 57A shows a patient when an implantable system 10 for handling an aneurysm on a blood vessel of the patient has been implanted. The system 10 comprises a vessel member 100, which is an adjustable vessel member 100, and further comprises a hydraulic, mechanical or electrical operation device for operating the vessel member 100. The vessel member is constantly or intermittently connected to the blood vessel comprising the aneurysm for exerting force on the blood vessel when needed to avoid expansion of the aneurysm. The vessel member 100 is connected to the controller 300 via a connection 650, which could be an electrical connection, a hydraulic conduit, a mechanical connection, or a combination thereof. The controller 300 (further described with reference to figure 57B) is configured to communicate with an external device 320 (further described with reference to figure 57C). The controller 300 can communicate wirelessly with the external device 320 through a wireless connection WL1, and/or through an electrical connection Cl. Referring now to figure 57B, one embodiment of the controller 300 will be describe in more detail. The controller 300 comprises an internal computing unit 306 configured to control the function performed by the implantable system 10. The computing unit 306 comprises an internal memory 307 configured to store programs thereon. In the embodiment described in fig. 57B, the internal memory 307 comprises a first control program 310 which can control the function of the system 10. The first control program 310 may be seen as a program with minimum functionality to be run at the implantable system 10 only during updating of the second control program 312. When the implantable system 10 is running with the first control program 310, the implantable system 10 may be seen as running in safe mode, with reduced functionality. For example, the first control program 310 may result in that no sensor data is stored in the implantable system 10 while being run, or that no feedback is transmitted from the implantable system 10 while the first control program 310 is running. By having a low complexity first control program, memory at the implantable system 10 is saved, and the risk of failure of the implantable system 10 during updating of the second control program 312 is reduced.
The second control program 312 is the program controlling the implantable system 10 in normal circumstances, providing the implantable system 10 with full functionality and features.
The memory 307 can further comprise a second, updatable, control program 312. The term updatable is to be interpreted as the program being configured to receive incremental or iterative updates to it’s code, or be replaced by a new version of the code. Updates may provide new and/or improved functionality to the implant as well as fixing previous deficiencies in the code. The computing unit 306 can receive updates to the second control program 312 via the controller 300. The updates can be received wirelessly WL1 or via the electrical connection Cl . As shown in figure 57B, the internal memory 307 of the controller 300 can possibly store a third program 314. The third program 314 can control the function of the implantable system 10 and the computing unit 306 may be configured to update the second program 312 to the third program 314. The third program 314 can be utilized when rebooting an original state of the second program 312. The third program 314 may thus be seen as providing a factory reset of the controller 300, e.g. restore it back to factory settings. The third program 314 may thus be included in the controller 300 in a secure part of the memory 307 to be used for resetting the software (second control program 312) found in the controller 300 to original manufacturer settings.
The controller 300 may comprise a reset function 316 connected to or part of the internal computing unit 306 or transmitted to said internal computing unit 306. The reset function 316 is configured to make the internal computing unit 306 switch from running the second control program 312 to the first control program 310. The reset function 316 could be configured to make the internal computing unit 306 delete the second control program 312 from the memory 307. The reset function 316 can be operated by palpating or pushing/put pressure on the skin of the patient. This could be performed by having a button on the implant. Alternatively, the reset function 316 can be invoked via a timer or a reset module. Temperature sensors and/ or pressure sensors can be utilized for sensing the palpating. The reset function 316 could also be operated by penetrating the skin of the patient. It is further plausible that the reset function 316 can be operated by magnetic means. This could be performed by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 could be configured such that it only responds to magnetic forces applied for a duration of time exceeding a limit, such as 2 seconds. The time limit could equally plausible be 5 or 10 seconds, or longer. In these cases, the implant could comprise a timer. The reset function 316 may thus include or be connected to a sensor for sensing such magnetic force.
In addition to or as an alternative to the reset function described above, the implant may comprise an internal computing unit 306 (comprising an internal processor) comprising the second control program 312 for controlling a function of the implantable system 10, and a reset function 318. The reset function 318 may be configured to restart or reset said second control program 312 in response to: i. a timer of the reset function 318 has not been reset, or ii. a malfunction in the first control program 310.
The reset function 318 may comprise a first reset function, such as, for example, comprise a computer operating properly, COP, function connected to the internal computing unit 306. The first reset function may be configured to restart or reset the first or the second control program 312 using a second reset function. The first reset function comprises a timer, and the first or the second control program is configured to periodically reset the timer.
The reset function 318 may further comprise a third reset function connected to the internal computing unit and to the second reset function. The third reset function may in an example be configured to trigger a corrective function for correcting the first 310 or second control program 312, and the second reset function is configured to restart the first 310 or second control program 312 sometime after the corrective function has been triggered. The corrective function may be a soft reset or a hard reset.
The second or third reset function may, for example, configured to invoke a hardware reset by triggering a hardware reset by activating an internal or external pulse generator which is configured to create a reset pulse. Alternatively, the second or third reset function may be implemented by software.
The controller 300 may further comprise an internal wireless transceiver 308. The transceiver 308 communicates wirelessly with the external device 320 through the wireless connection W1. The transceiver may further communicate with an external device 320, 300 via wireless connection WL2 or WL4. The transceiver may both transmit and receive data via either of the connections Cl, WL1, WL2 and WL4. Optionally, the external devices 320 and 300, when present, may communicate with each other, for example via a wireless connection WL3. The controller 300 can further be electrically connected Cl to the external device 320 and communicate by using the patient’s body as a conductor. The controller 300 may thus comprise a wired transceiver 303 or an internal transceiver 303 for the electrical connection Cl.
The confirmation/authentication of the electrical connection can be performed as described herein in the section for confirmation and/or authentication. In these cases, the implanted medical device and/or external device(s) 320 comprises the necessary features and functionality (described in the respective sections of this document) for performing such confirmation/authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
In figures 57A - 57C the patient is a human, but other mammals are equally plausible. It is also plausible that the communication is performed by inductive means. It is also plausible that the communication is direct.
The controller 300 of the implantable medical device 10 according to figure 57B further comprises a feedback unit 349. The feedback unit 349 provides feedback related to the switching from the second control program 312 to the first control program 310. The feedback could for example represent the information on when the update of the software, i.e. the second control program 312, has started, and when the update has finished. This feedback can be visually communicated to the patient, via for example a display on the external device 320. This display could be located on a watch, or a phone, or any other external device 320 coupled to the controller 300. Preferably, the feedback unit 349 provides this feedback signal wirelessly WL1 to the external device 320. Potentially, the words “Update started”, or “Update finished”, could be displayed to the patient, or similar terms with the same meaning. Another option could be to display different colors, where green for example could mean that the update has finished, and red or yellow that the update is ongoing. Obviously, any color is equally plausible, and the user could choose these depending on personal preference. Another possibility would be to flash a light on the external device 320. In this case the external device 320 comprises the light emitting device(s) needed. Such light could for example be a UED. Different colors could, again, represent the status of the program update. One way of representing that the update is ongoing and not yet finished could be to flash the light, i.e. turning the light on and off. Once the light stops flashing, the patient would be aware of that the update is finished. The feedback could also be audible, and provided by the implantable medical device 300 directly, or by the external device 320. In such cases, the implantable system 10 and external device 320 comprises means for providing audio. The feedback could also be tactile, for example in the form of a vibration that the user can sense. In such case, either the implantable system 10 or external device 320 comprises means for providing a tactile sensation, such as a vibration and/or a vibrator. As seen in figure 57B, the controller 300 can further comprise a first energy storage unit 40A. The first energy storage unit 40A runs the first control program 310. The controller 300 further comprises a second energy storage unit 40B which runs the second control program 312. This may further increase security during update, since the first control program 310 has its own separate energy storage unit 40A. The energy storage unit 40A can comprise a first energy storage 304a and/or a first energy receiver 305a. The second energy storage unit 40B can comprise a second energy storage 304b and/or a second energy receiver 305b. The energy can be received wirelessly by inductive or conductive means. An external energy storage unit can for example transfer an amount of wireless energy to the energy receiver 305a, 305b inside the patient’s body by utilizing an external coil which induces a voltage in an internal coil (not shown in figures). It is plausible that the first energy receiver 305a receives energy via a RFID pulse. The feedback unit 349 can provide feedback pertaining to the amount of energy received via the RFID pulse. The amount of RFID pulse energy that is being received can be adjusted based on the feedback, such that the pulse frequency is successively raised until a satisfying level is reached.
The controller 300 of the implantable system 10 according to figure 57B further comprises a feedback unit an electrical switch 309. The electrical switch 309 could be mechanically connected to the vessel member 100 and could be configured to be switched as a result of the force exerted on the blood vessel of the patient exceeding a threshold value. The switch 309 could for example be bonded to one of the hydraulic members being connected to the outside of the tissue wall of the blood vessel, in any of the embodiments herein, or to a portion of a fluid conduit, reservoir or hydraulic operation device, such as a pump, being in fluid connection with the vessel member and be switched by the expansion or movement of a hydraulic member of the vessel member. The switch 309 could alternatively be electrically connected to the operation device and being configured to be switched as a result of the current supplied to the operation device exceeding a threshold value. The switch 309 could for example be connected to the motor and be configured to be switched if the current to the motor exceeds a threshold value. Such a switch could for example be a switch 309 configured to switch if exposed to a temperature exceeding a threshold value, such as a bimetal switch which is switched by the heat created by the flow of current to e.g. the motor. In the alternative, the switch 309 configured to switch if exposed to a temperature exceeding a threshold value could be placed at a different location on the medical device 10 to switch in case of exceeding temperatures, thereby hindering the medical device from overheating which may cause tissue damage.
The switch 309 could either be configured to cut the power to the operation device or to generate a control signal to the processor 306 of the implantable controller 300, such that the controller 300 can take appropriate action, such as reducing power or turning off the operation device. The external device 320 is represented in figure 57C. The external device 320 can be placed anywhere on the patient’s body, preferably on a convenient and comfortable place. The external device 320 could be a wristband, and/or have the shape of a watch. It is also plausible that the external device is a mobile phone or other device not attached directly to the patient. The external device as shown in figure 57C comprises a wired transceiver 323, and an energy storage 324. It also comprises a wireless transceiver 328 and an energy transmitter 325. It further comprises a computing unit 326 and a memory 327. The feedback unit 322 in the external device 320 is configured to provide feedback related to the computing unit 326. The feedback provided by the feedback unit 322 could be visual. The external device 320 could have a display showing such visual feedback to the patient. It is equally plausible that the feedback is audible, and that the external device 320 comprises means for providing audio. The feedback given by the feedback unit 322 could also be tactile, such as vibrating. The feedback could also be provided in the form of a wireless signal WL1, WL2, WL3, WL4.
The second, third or fourth communication methods WL2, WL3, WL4 may be a wireless form of communication. The second, third or fourth communication method WL2, WL3, WL4 may preferably be a form of electromagnetic or radio-based communication. The second, third and fourth communication method WL2, WL3, WL4 may be based on telecommunication methods. The second, third or fourth communication method WL2, WL3, WL4 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G or 5G.
The external device 320 may be adapted to be in electrical connection Cl with the implanted system 10, using the body as a conductor. The electrical connection Cl is in this case used for conductive communication between the external device 320 and the implanted system 10.
In one embodiment, the communication between controller 300 and the external device 320 over either of the communication methods WL2, WL3, WL4, Cl may be encrypted and/or decrypted with public and/or private keys, now described with reference to Figs. 57A - 57C. For example, the controller 300 may comprise a private key and a corresponding public key, and the external device 320 may comprise a private and a corresponding public key.
The controller 320 and the external device 320 may exchange public keys and the communication may thus be performed using public key encryption. The person skilled in the art may utilize any known method for exchanging the keys.
The controller may encrypt data to be sent to the external device 320 using a public key corresponding to the external device 320. The encrypted data may be transmitted over a wired, wireless or electrical communication channel Cl, WL1, WL2, WL3 to the external device. The external device 320 may receive the encrypted data and decode it using the private key comprised in the external device 320, the private key corresponding to the public key with which the data has been encrypted. The external device 320 may transmit encrypted data to the controller 300. The external device 320 may encrypt the data to be sent using a public key corresponding to the private key of the controller 300. The external device 320 may transmit the encrypted data over a wired, wireless or electrical connection Cl, WL1, WL2, WL3, WL4, directly or indirectly, to the controller of the implant. The controller may receive the data and decode it using the private key comprised in the controller 300.
In an alternative to the public key encryption, described with reference to figs. 57A - 57C, the data to be sent between the controller 300 of the implantable implanted system 10 and an external device 320, 330 or between an external device 320, 330 and the controller 300 may be signed. In a method for sending data from the controller 300 to the external device 320, 330, the data to be sent from the controller 300 may be signed using the private key of the controller 300. The data may be transmitted over a communication channel or connection Cl, WL1, WL2, WL3, WL4. The external device 320, 330 may receive the message and verify the authenticity of the data using the public key corresponding to the private key of the controller 300. In this way, the external device 320, 330 may determine that the sender of the data was sent from the controller 300 and not from another device or source.
A method for communication between external devices and the controller 300 of the implantable implanted system 10 using a combined key is now described with reference to figs. 57A - 57C. A first step of the method comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, WL4 or otherwise, a first key from an external device 320, 330. The method further comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, a second key. The second key may be generated by a second external device, separate from the external device 320, 330 or by another external device being a generator of the second key on behalf of the second external device 320, 330. The second key may be received at the medical device from anyone of, the external device 320, the second external device 330, and the generator of the second key. The second external device may be controlled by a caretaker, or any other stakeholder. Said another external device may be controlled by a manufacturer of the implant, or medical staff, caretaker, etc.
In case the controller 300 is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from another external device (generator). The routing may be performed as described herein under the tenth aspect. In these cases, the implanted system and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information. The controller 300 a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller 300. The third key could for example be a license number of the implant or a chip number of the implanted system. The combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used for altering, by the computing unit 306 an operation of the implanted system. The altering an operation of the implanted system may comprise controlling or switching an active unit 302 of the implanted system 10. In some embodiments, the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the controller 300, and operating the implanted system 10 using operation instructions in the decrypted data.
Methods for encrypted communication between an external device 320 and the controller 300 are provided. These methods comprise: receiving, at the external device 320, by a wireless transceiver 328, a first key, the first key being generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 330, the first key being received from anyone of the second external device 330 and the generator of the second key, receiving, at the external device 320 by the wireless transceiver 328, a second key from the controller 300, deriving a combined key, by a computing unit 326 of the external device 320, by combining the first key and the second key with a third key held by the external device 320 (e.g. in memory 307), transmitting encrypted data from the implant to the external device and receiving the encrypted data at the external device by the wireless transceiver 328, and decrypting, by the computing unit 326, the encrypted data, in the external device 320, using the combined key.
As described above, further keys may be necessary to decrypt the data. Consequently, the wireless transceiver 328 is configured for: receiving a fourth key from a third external device, wherein the computing unit 326 is configured for: deriving a combined key by combining the first, second and fourth key with the third key held by the external device, and decrypting the encrypted data using the combined key.
These embodiments further increase the security in the communication. The computing unit 326 may be configured to confirm the communication between the implanted system and the external device, wherein the confirmation comprises: measuring a parameter of the patient, by the external device 320, receiving a measured parameter of the patient, from the implanted system 10, comparing the parameter measured by the implanted system 10 to the parameter measured by the external device 320, performing confirmation of the connection based on the comparison, and as a result of the confirmation, decrypting the encrypted data, in the external device, using the combined key.
The keys described in this section may in some embodiments be generated based on data sensed by sensors described herein under the twelfth or thirteenth aspect, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
Further, increased security for communication between an external device(s) and the implantable medical device is provided.
A method of communication between an external device 320 and an implanted system 10 is now described with reference to Figs. 57A - 57C, when the implanted system 10 is implanted in a patient and the external device 320 is positioned external to the body of the patient. The external device 320 is adapted to be in electrical connection Cl with the controller 300, using the body as a conductor. The electrical connection C 1 is used for conductive communication between the external device 320 and the implanted system 10. The implanted system 10 comprises the controller 300. Both the controller 300 and the external device 320 comprises a wireless transceiver 308, 208 for wireless communication Cl between the controller 300 and the external device 320. The wireless transceiver 308 (included in the controller 300) may in some embodiments comprise sub-transceivers for receiving data from the external device 320 and other external devices, e.g. using different frequency bands, modulation schemes etc.
In a first step of the method, the electrical connection Cl between the controller 300 and the external device 320 is confirmed and thus authenticated. The confirmation and authentication of the electrical connection may be performed as described herein under the fifth, thirteenth and fifteenth aspect. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
The controller 300 of the implanted system 10 may comprise a first transceiver 303 configured to be in electrical connection C 1 with the external device, using the body as a conductor. The controller 300 may further comprise a wireless transceiver 308 configured to transmit wireless communication W 1 from the controller 300. The first transceiver 323 of the external device 320 is a wired transceiver or a transceiver using the body as a conductor. The external device 32o further comprises a wireless transceiver 328 for wireless communication with the wireless transceiver 308 of the implantable controller 300.
The controller 300 may comprise a computing unit 306 configured to confirm the electrical connection between the external device 320 and the internal transceiver 303 and accept wireless communication WL1 (of the data) from the external device 320 on the basis of the confirmation.
Data is transmitted from the external device 320 to the controller 300 wirelessly, e.g. using the respective wireless transceiver 308, 328 of the controller 300 and the external device 320. Data may alternatively be transmitted through the electrical connection Cl. As a result of the confirmation, the received data may be used for instructing the implantable system 10. For example, a control program 310 running in the controller 300 may be updated, the controller 300 may be operated using operation instructions in the received data. This may be handled by the computing unit 306.
The method may comprise transmitting data from the external device 320 to the controller 300 wirelessly comprises transmitting encrypted data wirelessly. To decrypt the encrypted data (for example using the computing unit 306), several methods may be used.
In one embodiment, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller (by the first internal transceiver 303). The key is then used for decrypting the encrypted data.
In some embodiments the key is enough to decrypt the encrypted data. In other embodiments, further keys are necessary to decrypt the data. In one embodiment, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller 300 (by the first internal transceiver 303). A second key is transmitted (by the wireless transceiver 208) from the external device 320 using the wireless communication WL1 and received at the controller 300 by the wireless transceiver 308. The computing unit 306 is then deriving a combined key from the key and second key and uses this for decrypting the encrypted data.
In yet other embodiments, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller (by the first internal transceiver 303). A third key is transmitted from a second external device 330, separate from the external device 320, to the implant wirelessly WL2. The third key may be received by a second wireless receiver (part of the wireless transceiver 308) of the controller 300 configured for receiving wireless communication WL2 from second external device 330. The first and third key may be used to derive a combined key by the computing unit 306, which then decrypts the encrypted data. The decrypted data is then used for instructing the implantable system 10 as described above.
The second external device 330 may be controlled by for example a caregiver, to further increase security and validity of data sent and decrypted by the controller 300.
It should be noted that in some embodiments, the external device is further configured to receive WL2 secondary wireless communication from the second external device 330, and transmit data received from the secondary wireless communication WL2 to the implantable system 10. This routing of data may be achieved using the wireless transceivers 308, 328 (i.e. the wireless connection WL1, or by using a further wireless connection WL4 between the controller 300 and the external device 320. In these cases, the medical device and/or external device(s) comprises the necessary features and functionality for performing such routing. Consequently, in some embodiments, the third key is generated by the second external device 330 and transmitted WL2 to the external device 320 which routes the third key to the controller 300 to be used for decryption of the encrypted data. In other words, the step of transmitting a third key from a second external device, separate from the external device, to the implant wirelessly, comprises routing the third key through the external device 320. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.
In yet other embodiments, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the implant (by the first internal transceiver 303). A second key is transmitted from the external device 320 to the controller 300 wirelessly WL1, received at the at the controller 300. A third key is transmitted from the second external device, separate from the external device 320, to the controller 300 wirelessly WL4. Encrypted data transmitted from the external device 320 to the controller 300 is then decrypted using a derived combined key from the key, the second key and the third key. The external device may be a wearable external device.
The external device 320 may be a handset. The second external device 330 may be a handset. The second external device 330 may be a server. The second external device 330 may be cloud based.
In some embodiments, the electrical connection Cl between the external device 320 and the controller 300 is achieved by placing a conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication Cl with the implantable system 10. In these cases, the implantable system 10 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such conductive communication. The communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 321, conductive connection Cl, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient.
The keys described in this section may in some embodiments be generated based on data sensed by sensors described herein, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
Increased security for communication between an external device(s) and an implantable system 10 is provided, now described with reference to figs. 57A - 57C.
In these embodiments, a method for communication between an external device 320 and the implantable controller 300 is provided. The wireless transceiver 308 (included in the controller 300) may in some embodiments comprise sub-transceivers for receiving data from the external device 320 and other external devices 330, e.g. using different frequency bands, modulation schemes etc.
A first step of the method comprises receiving, at the implantable system 10, by a wireless transmission WL1 or otherwise, a first key from an external device 320. The method further comprises receiving, at the implantable system 10, by a wireless transmission WL1, WL2, WL3, a second key. The second key may be generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 330. The second key may be received at the implantable system 10 from anyone of, the external device 320, the second external device 330, and a generator of the second key. The second external device 330 may be controlled by a caretaker, or any other stakeholder. Said another external device may be controlled by a manufacturer of the medical device, or medical staff, caretaker, etc.
In case the implantable system 10 is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from the another external device (generator). In these cases, the implantable system 10 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information. The controller 300 comprises a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller. The combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used for altering, by the computing unit 306 an operation of the implantable system 10. The altering an operation of the implantable system 10 may comprise controlling or switching an active unit 302 of the implantable system 10. In some embodiments, the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the implant, and operating the implantable system 10 using operation instructions in the decrypted data.
In some embodiments, further keys are necessary to derive a combined key for decrypting the encrypted data received at the controller 300. In these embodiments, the first and second key are received as described above. Further, the method comprises receiving, at the implantable system 10, a fourth key from a third external device, the third external device being separate from the external device, deriving a combined key by combining the first, second and fourth key with the third key held by the controller 300, and decrypting the encrypted data, in the controller 300, using the combined key. Optionally, the decrypted data may be used for altering, by the computing unit 306, an operation of the implantable system 10 as described above. In some embodiments, the fourth key is routed through the external device from the third external device.
In some embodiments, further security measures are needed before using the decrypted data for altering, by the computing unit 306, an operation of the implantable system 10. For example, an electrical connection Cl between the implantable system 10 and the external device 320, using the body as a conductor, may be used for further verification of validity of the decrypted data. The electrical connection Cl may be achieved by placing a conductive member 321, configured to be in connection with the external device, in electrical connection with a skin of the patient for conductive communication Cl with the implantable system 10. The communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 321, conductive connection Cl, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient.
Accordingly, in some embodiments, the method comprising confirming the electrical connection between the controller 300 and the external device 320, and as a result of the confirmation, altering an operation of the implantable system 10 based on the decrypted data. The confirmation and authentication of the electrical connection may be performed as described herein under the general features section. In these cases, the implantable system 10 and/or external device(s) 320 comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
In some embodiments, the confirmation of the electrical connection comprises: measuring a parameter of the patient, by e.g. a sensor of the implantable system 10, measuring the parameter of the patient, by the external device 320, comparing the parameter measured by the implantable system to the parameter measured by the external device 320, and authenticating the connection based on the comparison. As mentioned above, as a result of the confirmation, an operation of the implantable system 10 may be altered based on the decrypted data.
Further methods for encrypted communication between an external device 320 and an implantable system 10 are provided. These methods comprise: receiving, at the external device 320 by a wireless transceiver 328, a first key, the first key being generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 320, the first key being received from anyone of the second external device 330 and the generator of the second key, receiving, at the external device 320 by the wireless transceiver 328, a second key from the controller 300, deriving a combined key, by a computing unit 326 of the external device 320, by combining the first key and the second key with a third key held by the external device 320 (e.g. in memory 327), transmitting encrypted data from the implant to the external device and receiving the encrypted data at the external device by the wireless transceiver 328, and decrypting, by the computing unit 326, the encrypted data, in the external device 320, using the combined key.
As described above, further keys may be necessary to decrypt the data. Consequently, the wireless transceiver 328 is configured for: receiving a fourth key from a third external device, wherein the computing unit 326 is configured for: deriving a combined key by combining the first, second and fourth key with the third key held by the external device, and decrypting the encrypted data using the combined key.
In some embodiments, the communication between the controller 300 and the external device 320 needs to be confirmed (authenticated) before decrypting the data. In these cases, the implantable medical device and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication. These embodiments further increase the security in the communication. In these embodiments the computing unit 326 is configured to confirm the communication between the implantable system 10 and the external device, wherein the confirmation comprises: measuring a parameter of the patient, by the external device 320, receiving a measured parameter of the patient, from the implantable system 10, comparing the parameter measured by the implantable system 10 to the parameter measured by the external device 320, performing confirmation of the connection based on the comparison, and as a result of the confirmation, decrypting the encrypted data, in the external device, using the combined key.
One or more of the first, second and third key may comprise a biometric key.
The keys described in this section may in some embodiments be generated based on data sensed by sensors, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
Further, increased security for communication between an external device(s) 320, 330 and an implantable medical device is provided, described with reference to Figs. 57A - 57C. The system being configured for enabling communication between an external device 320 and the controller 300 implanted in a patient. The system comprises a conductive member 321 configured to be in connection (electrical/conductive or wireless or otherwise) with the external device, the conductive member 321 being configured to be placed in electrical connection with a skin of the patient for conductive communication Cl with the implantable system 10. By using a conductive member 321 as defined herein, an increased security for communication between the external device and the implantable system 10 may be achieved. For example, when a sensitive update of a control program of the controller 300 is to be made, or if sensitive data regarding physical parameters of the patient is to be sent to the external device 320 (or otherwise), the conductive member 321 may ensure that the patient is aware of such communication and actively participate in validating that the communication may take place. The conductive member may, by being placed in connection with the skin of the patient, open the conductive communication channel Cl between the external device and the controller to be used for data transmission.
Electrical or conductive communication, such as this or as described under the other embodiments, may be very hard to detect remotely, or at least relatively so, in relation to wireless communications such as radio transmissions. Direct electrical communication may further safeguard the connection between the implantable system 10 and the external device 320 from electromagnetic jamming i.e. high-power transmissions other a broad range of radio frequencies aimed at drowning other communications within the frequency range. Electrical or conductive communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient, providing an extra level of security to the communication.
In some embodiments, the conductive member comprises a conductive interface for connecting the conductive member to the external device.
In some embodiments, the conductive member 201 is a device which is plugged into the external device 200, and easily visible and identifiable for simplified usage by the patient. In other embodiments, the conductive member 321 is to a higher degree integrated with the external device 320, for example in the form of a case of the external device 320 comprising a capacitive area configured to be in electrical connection with a skin of the patient. In one example, the case is a mobile phone case (smartphone case) for a mobile phone, but the case may in other embodiments be a case for a personal computer, or a body worn camera or any other suitable type of external device as described herein. The case may for example be connected to the phone using a wire from the case and connected to the headphone port or charging port of the mobile phone.
The conductive communication C 1 may be used both for communication between the controller 300 and the external device 320 in any or both directions. Consequently, according to some embodiments, the external device 320 is configured to transmit a conductive communication (conductive data) to the controller 300 via the conductive member 321.
According to some embodiments, the controller 300 is configured to transmit a conductive communication to the external device 320. These embodiments start by placing the conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication Cl with the controller 300. The conductive communication between the external device 320 and the controller 300 may follow an electrically/conductively confined path comprising e.g. the external device 320, conductive member 321, conductive connection Cl, controller 300.
For the embodiments when the external device 320 transmits data to the controller, the communication may comprise transmitting a conductive communication to the controller 300 by the external device 320.
The transmitted data may comprise instructions for operating the implantable system 10. Consequently, some embodiments comprise operating the implantable system 10 using operation instructions, by an internal computing unit 306 of the controller 300, wherein the conductive communication Cl comprises instructions for operating the implantable system 10. The operation instruction may for example involve adjusting or setting up (e.g. properties or functionality of) the active unit 302 of the implantable system 10.
The transmitted data may comprise instructions for updating a control program 310 stored in memory 307 of the controller 300. Consequently, some embodiments comprise updating the control program 310 running in the controller 300, by the internal computing unit 306 of the implantable system 10, wherein the conductive communication comprises instructions for updating the control program 310.
For the embodiments when the controller 300 transmits data to the external device 320, the communication may comprise transmitting conductive communication C 1 to the external device 320 by the controller 300. The conductive communication may comprise feedback parameters. Feedback parameters could include battery status, energy level at the controller, the fluid level of the hydraulic restriction device, number of operations that the restriction device has performed, properties, version number etc. relating to functionality of the implantable system 10. In other embodiments, the conductive communication C 1 comprises data pertaining to least one physiological parameter of the patient, such as blood pressure etc. The physiological parameter(s) may be stored in memory 307 of the controller 300 or sensed in prior (in real time or with delay) to transmitting the conductive communication C 1. Consequently, in some embodiments, the implantable system 10 comprises a sensor 606’ for sensing at least one physiological parameter of the patient, wherein the conductive communication comprises said at least one physiological parameter of the patient.
To further increase security of the communication between the controller 300 and the external device 320, different types of authentication, verification and/or encryption may be employed. In some embodiments, the external device 320 comprises a verification unit 340. The verification unit 340 may be any type of unit suitable for verification of a user, i.e. configured to receive authentication input from a user, for authenticating the conductive communication between the implantable system 10 and the external device. In some embodiments, the verification unit and the external device comprises means for collecting authentication input from the user (which may or may not be the patient). Such means may comprise a fingerprint reader, a retina scanner, a camera, a GUI for inputting a code, a microphone, device configured to draw blood, etc. The authentication input may thus comprise a code or any be based on a biometric technique selected from the list of: a fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison. The means for collecting the authentication input may alternatively be part of the conductive member which comprise any of the above examples of functionality, such as a fingerprint reader or other type of biometric reader.
In some embodiments, the security may thus be increased by receiving an authentication input from a user by the verification unit 340 of the external device 320, and authenticating the conductive communication between the controller 300 and the external device using the authentication input. Upon a positive authentication, the conductive communication channel Cl may be employed for comprising transmitting a conductive communication to the controller 300 by external device 320 and/or transmitting a conductive communication to the external device 320 by the controller 300. In other embodiments, a positive authentication is needed prior to operating the implantable system 10 based on received conductive communication, and/or updating a control program running in the controller 300 as described above.
Figs. 57A - 57C further shows an implantable system 10 implanted in a patient and being connected to a sensation generator 381.
The sensation generator 381 may be configured to generate a sensation. The sensation generator 381 may be contained within the implantable system 10 or be a separate unit. The sensation generator 381 may be implanted. The sensation generator 381 may also be located so that it is not implanted as such but still is in connection with a patient so that only the patient may experience sensations generated. The controller 300 is configured for storing authentication data, related to the sensation generated by the sensation generator 381.
The controller 300 is further configured for receiving input authentication data from the external device 320. Authentication data related to the sensation generated may by stored by a memory 307 of the controller 300. The authentication data may include information about the generated sensation such that it may be analyzed, e.g. compared, to input authentication data to authenticate the connection, communication or device. Input authentication data relates to information generated by a patient input to the external device 320. The input authentication data may be the actual patient input or an encoded version of the patient input, encoded by the external device 320. Authentication data and input authentication data may comprise a number of sensations or sensation components.
The authentication data may comprise a timestamp. The input authentication data may comprise a time stamp of the input from the patient. The timestamps may be a time of the event such as the generation of a sensation by the sensation generator 381 or the creation of input authentication data by the patient. The timestamps may be encoded. The timestamps may feature arbitrary time units, i.e. not the actual time. Timestamps may be provided by an internal clock 360 of the controller 300 and an external clock 362 of the external device 320. The clocks 360, 362 may be synchronized with each other. The clocks 360, 362 may be synchronized by using a conductive connection Cl or a wireless connection WL1 for communicating synchronization data from the external device 320, and its respective clock 362, to the controller 300, and its respective clock 360, and vice versa. Synchronization of the clocks 360, 362 may be performed continuously and may not be reliant on secure communication.
Authentication of the connection may comprise calculating a time difference between the time stamp of the sensation and the time stamp of the input from the patient, and upon determining that the time difference is less than a threshold, authenticating the connection. An example of a threshold may be Is. The analysis may also comprise a low threshold as to filter away input from the patient that is faster than normal human response times. The low threshold may e.g. be 50ms.
Authentication data may comprise a number of times that the sensation is generated by the sensation generator, and wherein the input authentication data comprises an input from the patient relating to a number of times the patient detected the sensation. Authenticating the connection may then comprise: upon determining that the number of times that the authentication data and the input authentication data are equal, authenticating the connection.
A method of authenticating the connection between an implantable system 10 implanted in a patient, and an external device 320 according includes the following steps.
Generating, by a sensation generator 381, a sensation detectable by a sense of the patient. The sensation may comprise a plurality of sensation components. The sensation or sensation components may comprise a vibration (e.g. a fixed frequency mechanical vibration), a sound (e.g. a superposition of fixed frequency mechanical vibrations), a photonic signal (e.g. a non-visible light pulse such as an infra-red pulse), a light signal (e.g. a visual light pulse), an electric signal (e.g. an electrical current pulse) or a heat signal (e.g. a thermal pulse). The sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm.
Sensations may be configured to be consistently felt by a sense of the patient while not risking harm to or affecting internal biological processes of the patient.
The sensation generator 381, may be contained within the controller 300 or be a separate entity connected to the controller 300. The sensation may be generated by a motor (denoted as M in several embodiments shown herein) of the implantable system 10, wherein the motor being the sensation generator 381. The sensation may be a vibration, or a sound created by running the motor. The sensation generator 381 may be located close to a skin of the patient and thus also the sensory receptors of the skin. Thereby the strength of some signal types may be reduced.
Storing, by the controller 300, authentication data, related to the generated sensation.
Providing, by the patient input to the external device, resulting in input authentication data. Providing the input may e.g. comprise an engaging an electrical switch, using a biometric input sensor or entry into digital interface running on the external device 320 to name just a few examples.
Transmitting the input authentication data from the external device to the controller 300. If the step was performed, the analysis may be performed by the controller 300.
Transmitting the authentication data from the implantable system 10 to the external device 320. If the step was performed, the analysis may be performed by the external device 320. The wireless connection WL1 or the conductive connection Cl may be used to transmit the authentication data or the input authentication data.
Authenticating the connection based on an analysis of the input authentication data and the authentication data e.g. by comparing a number of sensations generated and experienced or comparing timestamps of the authentication data and the input authentication data. If step was performed, the analysis may be performed by the implantable system 10. Communicating further data between the controller 300 and the external device 320 following positive authentication. The wireless connection WL1 or the conductive connection Cl may be used to communicate the further data. The further data may comprise data for updating a control program 310 running in the controller 300 or operation instructions for operating the implantable system 10. The further data may also comprise data sensed by a sensor 606’ connected to the controller 300. The controller may comprise at least one unit having a sleep mode and an active mode, and the unit consumes less energy in the sleep mode than in the active mode. The unit is configured to switch from the sleep mode to the active mode on the basis of at least one signal from the sensor. The unit could for example be a DSP (Digital Signal Processor), another type of processor or a wake-up circuit of the controller, which in turn activates the functions of the controller. The unit may be configured to switch from the sleep mode to the active mode on the basis of a signal from the sensor related to the patient swallowing a number of times and/or on the basis of a signal from the sensor related to the patient swallowing a number of times during a time period. The number of times the patient swallows and the time could be counted/measured and compared with a pre-set or moving threshold value. The controller could further comprise at least one filtering unit configured to filter signals related to at least one of: speech, the swallowing of saliva and chewing. The filter could be a digital filter implemented as hardware or software in the controller and could have the filter characteristics of a high, low or bandpass filter.
If the analysis was performed by the controller 300, the external device 320 may continuously request or receive, information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the external device 320, that the connection is authenticated, transmitting further data from the external device 320 to the controller 300.
If the analysis was performed by the external device 320, the controller 300 may continuously request or receive, information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the controller 300, that the connection is authenticated, transmitting further data from the controller 300 to the external device 320.
A main advantage of authenticating a connection according to this method is that only the patient may be able to experience the sensation. Thus, only the patient may be able to authenticate the connection by providing authentication input corresponding to the sensation generation.
The sensation generator 381, sensation, sensation components, authentication data, input authentication data, and further data may be further described herein. In these cases, the implantable system 10 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document). Further information and definitions can be found in this document in conjunction with the other aspects. The method may further comprise transmitting further data between the controller 300 and the external device, wherein the further data is used or acted upon, only after authentication of the connection is performed.
The analysis or step of analyzing may be understood as a comparison or a step of comparing.
In one method, increased security for communication between an external device(s) and an implanted controller is provided. Figs. 57A - 57C show an implantable system 10 comprising a controller 300 and an external device 320 which may form a system.
The controller 300 comprises a transceiver 308, 303 configured to establish a connection with an external device 320, i.e. with a corresponding transceiver 328, 323. The connection may be an electrical connection Cl using the transceivers 303, 323, or a wireless connection WL1 using the transceivers 308, 328. The controller 300 further comprises a computing unit 306 configured to verify the authenticity of instructions received at the transceiver 308, 303 from the external device 320. In this aspect, the concept of using previously transmitted instructions for verifying a currently transmitted instructions are employed. Consequently, the transmitting node (in this case the external device) need to be aware of previously instructions transmitted to the implantable system 10, which reduces the risk of a malicious device instructing the implant without having the authority to do so.
In an embodiment, the computing unit 306 is configured to verify the authenticity of instructions received at the transceiver 308, 303 by extracting a previously transmitted set of instructions from a first combined set of instructions received by the transceiver. The external device 320 may thus comprise an external device comprising a computing unit 326 configured for: combining a first set of instructions with a previously transmitted set of instructions, forming a combined set of instructions, and transmitting the combined set of instructions to the implantable system 10. The previously transmitted set of instructions, or a representation thereof, may be stored in memory 327 of the external device 320.
The combined set of instructions may have a data format which facilitates such extraction, for example including metadata identifying data relating to the previously transmitted set of instructions in the combined set of instructions. In some embodiments, the combined set of instructions comprises the first set of instructions and a cryptographic hash of the previously transmitted set of instructions. Consequently, the method comprises combining, at the external device, a first set of instructions with a previously transmitted set of instructions, forming a first combined set of instructions. A cryptographic hash function is a special class of hash function that has certain properties which make it suitable for use in cryptography. It is a mathematical algorithm that maps data of arbitrary size to a bit string of a fixed size (a hash) and is designed to be a oneway function, that is, a function which is infeasible to invert. Examples include MD5, SHA1, SHA 256, etc. Increased security is thus achieved. The first combined set of instructions is then transmitted to the implanted controller 300, where it is received by e.g. the transceiver 303, 308. The first combined set of instructions may be transmitted to the implantable system 10 using a proprietary network protocol. The first combined set of instructions may be transmitted to the controller 300 using a standard network protocol. In these cases, the controller 300 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing transmission of data. By using different communication protocols, at the external device 320, for communication with the controller 300 and with a second external device 330, an extra layer of security is added as the communication between controller 300 and the external device 320 may be made less directly accessible to remote third parties.
At the controller 300, the computing unit 306 verifies the authenticity of the received first combined set of instructions, by: extracting the previously transmitted set of instructions from the first combined set of instructions, and comparing the extracted previously transmitted set of instructions with previously received instructions stored in the implantable system 10.
Upon determining that the extracted previously transmitted set of instructions equals the previously received instructions stored in the controller 300, the authenticity of the received first combined set of instructions may be determined as valid, and consequently, the first set of instructions may be safely run at the controller 300, and the first combined set of instructions may be stored in memory 307 of the controller 300, to be used for verifying a subsequent received set of instructions.
In some embodiments, upon determining by the internal computing unit 306 that the extracted previously transmitted set of instructions differs from the previously received instructions stored in the controller 300, feedback related to an unauthorized attempt to instruct the implantable system 10 may be provided. For example, the transceiver 308, 303 may send out a distress signal to e.g. the external device 320 or to any other connected devices. The controller 300 may otherwise inform the patient that something is wrong by e.g. vibration or audio. The implantable system 10 may be run in safe mode, using a preconfigured control program which is stored in memory 307 of the controller 300 and specifically set up for these situations, e.g. by requiring specific encoding to instruct the implantable system 10, or only allow a predetermined device (e.g. provided by the manufacturer) to instruct the implantable system 10. In some embodiments, when receiving such feedback at the external device 320, the external device 320 retransmits the first combined set of instructions again, since the unauthorized attempt may in reality be an error in transmission (where bits of the combined set of instructions are lost in transmission), and where the attempt to instruct the implantable system 10 is indeed authorized.
The step of comparing the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300 may be done in different ways. For example, the step of comparing the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300 comprises calculating a difference between the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300, and comparing the difference with a threshold value, wherein the extracted previously transmitted set of instructions is determined to equal the previously received instructions stored in the controller 300 in the case of the difference value not exceeding the threshold value. This embodiment may be used when received instructions is stored in clear text, or a representation thereof, in the controller 300, and where the combined set of instructions, transmitted from the external device also includes such a representation of the previously transmitted instructions. This embodiment may be robust against error in transmission where bits of information are lost or otherwise scrambled.
In other embodiments, the combined set of instructions comprises the first set of instructions and a cryptographic hash of the previously transmitted set of instructions, wherein the method further comprises, at the controller 300, calculating a cryptographic hash of the previously received instructions stored in the controller 300 and comparing the calculated cryptographic hash to the cryptographic hash included in the first combined set of instructions. This embodiment provides increased security since the cryptographic hash is difficult to decode or forge.
The above way of verifying the authenticity of received instructions at the controller 300 may be iteratively employed for further sets if instructions.
To further increase security, the transmission of a first set of instructions, to be stored at the controller 300 for verifying subsequent sets of combined instructions, where each set of received combined instructions will comprise data which in some form will represent, or be based on, the first set of instruction, may be performed.
In one example, the external device 320 may be adapted to communicate with the controller 300 using two separate communication methods. A communication range of a first communication method WL1 may be less than a communication range of a second communication method WL2. A method may comprise the steps of: sending a first part of a key from the external device 320 to the controller 300, using the first communication method WL1 and sending a second part of the key from the external device 320 to the controller 300, using the second communication method WL2. The method may further comprise deriving, in the controller 300, a combined key from the first part of the key and the second part of the key and decrypting the encrypted data, in the controller 300, using the combined key. The encrypted data may also be sent from the external device 320 to the controller 300 using the second communication method WL2. The method may then further comprise confirming an electrical connection Cl between the controller 300 and the external device 320 and as a result of the confirmation, decrypting the encrypted data in the controller 300 and using the decrypted data for instructing the controller 300.
The method may also comprise placing a conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication with the controller 300. By means of the electrical connection an extra layer of security is added as a potential hacker would have to be in contact with the patient to access or affect the operation of the implantable system 10.
Using a plurality of communication methods, may increase the security of the authentication and the communication with the implantable system 10 as more than one channel for communication may need to be hacked or hijacked by an unauthorized entity to gain access to the implantable system 10 or the communication.
The electrical connection Cl the conductive member 321 and conductive communication may be further described herein in the general definitions section. In these cases, the controller 300 and/or external device 320 comprise the necessary features and functionality (described in the respective sections of this document).
It should also be noted that any one of the first and second communication methods WL1, WL2 may be needed to be confirmed in order to decrypt the encrypted data in the controller 300 and using the decrypted data for instructing the implantable system 10.
The method may further comprise the step of wirelessly receiving, at the controller 300, a third part of the key from the second external device 330. In this case, the combined key may be derived from the first part of the key, the second part of the key and the third part of the key.
The first communication method WL1 may be a wireless form of communication. The first communication method WL1 may preferably be a form of electromagnetic or radio-based communication however, other forms of communication are not excluded. The first communication method WL1 may comprise or be related to the items of the following list: Radio-frequency identification (RFID), Bluetooth, Bluetooth 5, Bluetooth Low Energy (BLE), Near Field Communication (NFC), NFC-V, Infrared (IR) based communication, Ultrasound based communication.
RFID communication may enable the use of a passive receiver circuit such as those in a RFID access/key or payment card. IR based communication may comprise fiber optical communication and IR diodes. IR diodes may alternatively be used directly, without a fiber, such as in television remote control devices. Ultrasound based communication may be based on the non- invasive, ultrasound imaging found in use for medical purposes such as monitoring the development of mammal fetuses.
The first communication method WL1 may use a specific frequency band. The frequency band of the first communication method WL1 may have a center frequency of 13.56 MHz or 27.12 MHz. These bands may be referred to as industrial, scientific and medical (ISM) radio bands. Other ISM bands not mentioned here may also be utilized for the communication methods WL1, WL2. A bandwidth of the 13.56 MHz centered band may be 14 kHz and a bandwidth of the 27. 12 MHz centered band may be 326 kHz. The communication range of the first communication method WL1 may be less than 10 meters, preferably less than 2 meters, more preferably less than 1 meter and most preferably less than 20 centimeters. The communication range of the first communication method WL1 may be limited by adjusting a frequency and/or a phase of the communication. Different frequencies may have different rates of attenuation. By implementing a short communication range of the first communication method, security may be increased since it may be ensured or made probable that the external device is under control of the patient (holding the external device close to the implant) The communication range of the first communication method WL1 should be evaluated by assuming that a patient’s body, tissue, and bones present the propagation medium. Such a propagation medium may present different attenuation rates as compared to a free space of an airfilled atmosphere or a vacuum.
By restricting the communication range, it may be established that the external device communicating with the implanted controller 300 is in fact on, or at least proximal to, the patient. This may add extra security to the communication.
The second communication method WL2 may be a wireless form of communication. The second communication method WL2 may preferably be a form of electromagnetic or radio-based communication. The second communication method WL2 may be based on telecommunication methods. The second communication method WL2 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G, 5G.
The second communication method WL2 may utilize the ISM bands as mentioned in the above for the first communication method WL1.
A communication range of the second communication method WL2 may be longer than the communication range of the first communication method WL1. The communication range of the second communication method WL2 may preferably be longer than 10 meters, more preferably longer than 50 meters, and most preferably longer than 100 meters.
Encrypted data may comprise instructions for updating a control program 310 running in the implantable system 10. Encrypted data may further comprise instructions for operating the implantable system 10.
In one embodiment, the implantable system 10 may transmit data to an external device 320 which may add an additional layer of encryption and transmit the data to a second external device 330, described with reference to figs. 57A - 57C. By having the external device add an additional layer of encryption, less computing resources may be needed in the implanted controller 300, as the controller 300 may transmit unencrypted data or data encrypted using a less secure or less computing resource requiring encryption. In this way, data can still be relatively securely transmitted to a third device. The transmission of data can be performed using any of the method described herein in addition to the method or in the system described below. Thus, in an embodiment, a system is provided. The system comprises an implantable controller 300 configured to transmit data from the body of the patient to an external device 320, and an encryption unit 382 for encrypting the data to be transmitted. The system further comprises an external device 320 configured to receive the data transmitted by the controller 300, encrypt the received data using a first key and transmit the encrypted received data to a third external device 330. The encryption can be performed using any of the keys described above or below. In some embodiments, the external device 320 is configured to decrypt the data received from the controller 300 before encrypting and transmitting the data. Alternatively, the external device 320 may encrypt and transmit the data received from the controller 300 without decrypting it first.
In one example, the encryption unit 382 is configured to encrypt the data to be transmitted using a second key. The first key or the second key may, for example, information specific to the implantable system 10, a secret key associated with the external device 320, an identifier of the implantable system 10 or an identifier of the controller 300. The second key could be a key transmitted by the external device 320 to the controller 300. In some examples, the second key is a combined key comprising a third key received by the controller 300 from the external device 320.
The first key may be a combined key comprising a fourth key, wherein the fourth key is received by the external device 320 from a fourth device. The fourth device may be a verification unit, either comprised in the external device, or external to the external device and connected to it. The verification unit may have a sensor 606” for verification, such as a fingerprint sensor. More details in regard to this will be described below. Alternatively, the verification unit may be a generator, as described above.
The system may be configured to perform a method for transmitting data using a sensed parameter. The method may comprise transmitting a parameter measured by the external device 320 from the external device 320 to the controller 300. In this case, the comparison of the parameter of the patient measured by the external device 320 and the parameter of the patient measured by the controller 300 may be performed by the controller 300. The implantable system 10 may comprise a first sensor 606’ for measuring the parameter of the patient at the implantable system 10. The external device 320 may comprise an external sensor 606” for measuring the parameter of the patient at the external device 320.
Authentication of the connection between the controller 300 and the external device 320 may be performed automatically without input, authentication, or verification from a user or patient. This is because the comparison of parameters measured internally and externally, by the internal and external sensors 606’, 606” respectively may be enough to authenticate the connection. This may typically be the case when the parameter of the patient is related to an automatically occurring physiological function of the patient such as e.g. a pulse of the patient. Certain types of authentication may however require actions from the patient, e.g. having the patient perform specific movements. In the embodiments described herein, the controller 300 may comprise or be connected to a sensation generator 381 as described above. In response to an event in the implantable system 10, such as a reset, a restart, receipt of new instructions, receipt of a new configuration or update, installation or activation of new instructions or configuration or update, the controller 300 may be configured to cause the sensation generator 381 to generate a sensation detectable by the patient in which the implantable system 10 is implanted. In some examples, the user may after the sensation verify an action, for example via a user interface of an external device 320.
The implantable system 10 may further implement a method for improving the security of the data transmitted from the controller 300. The method, for encrypted communication between a controller 300, when implanted in a patient’s body, and an external device 320, comprises encoding or encrypting, by the controller 300 or a processor 306 comprised in or connected to the controller 300, data relating to the implantable system 10 or the operation thereof; transmitting, by the controller 300, the data; receiving, by a second communication unit comprised the external device 320, the data; encrypting, by the external device 320, the data using an encryption key to obtain encrypted data; and transmitting the encrypted data to a third external device 330. In this way, the external device 320 may add or exchange the encryption, or add an extra layer of encryption, to the data transmitted by the controller 300. When the controller 300 encodes the data to be transmitted it may be configured to not encrypt the data before transmitting, or only using a light-weight encryption, thus not needing as much processing power as if the controller were to fully encrypt the data before the transmission.
The encrypting, by the controller 300, may comprise encrypting the data using a second key. The encryption using the second key may be a more light-weight encryption than the encryption performed by the external device using the second key, i.e. an encryption that does not require as much computing resources as the encryption performed by the external device 320.
The first or the second key may comprise a private key exchanged as described above with reference to encryption and authentication, or the first or the second key may comprise an information specific to the implantable system 10, a secret key associated with the external device, an identifier of the implantable system 10 or an identifier of the controller 300. They may be combined keys as described in this description, and the content of the keys, any combination of keys, and the exchange of a key or keys is described in the encryption and/or authentication section.
In an embodiment, the implantable system 10 comprises at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implantable system 10, now described with reference to figs. 57A - 57C. The sensor 606’ may, for example, be a pressure sensor, an electrical sensor, a clock, a temperature sensor, a motion sensor, an optical sensor, a acoustic sensor, an ultrasonic sensor. The sensor 606’ is configured to periodically sense the parameter and the controller 300 is configured to, in response to the sensed parameter being above a predetermined threshold, wirelessly broadcast information relating to the sensed parameter. The controller 300 may be configured to broadcast the information using a short to mid-range transmitting protocol, such as a Radio Frequency type protocol, a RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, a NFC type protocol, a 3G/4G/5G type protocol, or a GSM type protocol.
The controller 300 of the implant may be connected to the sensor 606’ and be configured to anonymize the information before it is transmitted. The transmission of data may also be called broadcasting of data.
In addition to or as an alternative to transmitting the data when the sensed parameter is above a predetermined threshold, the controller 300 may be configured to broadcast the information periodically. The controller 300 may be configured to broadcast the information in response to a second parameter being above a predetermined threshold. The second parameter may, for example, be related to the controller 300 itself, such as a free memory or free storage space parameter, or a battery status parameter. When the implantable system 10 comprises an implantable energy storage unit and an energy storage unit indicator, the energy storage unit indicator is configured to indicate a functional status of the implantable energy storage unit and the indication may be comprised in the transmitted data. The functional status may indicate at least one of charge level and temperature of the implantable energy storage unit.
In some embodiments the external device 320 is configured to receive the broadcasted information, encrypt the received information using an encryption key and transmit the encrypted received information. In this way, the external device 320 may add an additional layer of encryption or exchange the encryption performed by the controller 300.
In an embodiment, the controller 300 is configured to transmit the data using the body of the patient as a conductor Cl, and the external device 320 is configured to receive the data via the body. Alternatively, or in combination, the controller 300 of the implant is configured to transmit the data wirelessly to the external device WL2.
Thus, the controller 300 may implement a method for transmitting data from the controller 300 comprising a processor 306, comprising: obtaining sensor measurement data via a sensor 606’ connected to or comprised in the controller 300, the sensor measurement relating to at least one physiological parameter of the patient or a functional parameter of the implantable system 10, and transmitting by the controller 300 the sensor measurement data in response to the sensor measurement being above a predetermined threshold, wherein the sensor 606’ is configured to periodically sense the parameter. The method may further comprise broadcasting the sensor measurement data, to be received by an external device 320. The transmitting or broadcasting may comprise using at least one of a Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, or a GSM type protocol. The method may further comprise, at the processor 306, anonymizing, by the processor, the sensor measurement data before it is transmitted, or encrypting the sensor measurement data, using an encryptor 382 comprised in the processing unit 306, before it is transmitted. The transmitting of the data may further comprise to encode the data before the transmitting. The type of encoding may be dependent on the communication channel or the protocol used for the transmission.
The transmitting may be performed periodically, or in response to a signal received by the processor, for example, by an internal part of the implantable system 10 such as a sensor 606’, or by an external device 320.
The parameter may, for example, be at least one of a functional parameter of the implantable system 10 (such as a battery parameter, a free memory parameter, a temperature, a pressure, an error count, a status of any of the control programs, or any other functional parameter mentioned in this description) or a parameter relating to the patient (such as a temperature, a blood pressure, or any other parameter mentioned in this description). In one example, the implantable system 10 comprises an implantable energy storage unit 40 and an energy storage unit indicator 304c, and the energy storage unit indicator 304c is configured to indicate a functional status of the implantable energy storage unit 40, and the sensor measurement comprises data related to the energy storage unit indicator.
In one example, the transmitting comprises transmitting the sensor measurement to an internal processor 306 configured to cause a sensation generator 381 to cause a sensation detectable by the patient in which the implantable system 10 is implanted.
The method may be implemented in a system comprising the implantable system 10 and an external device 320, and further comprise receiving the sensor measurement data at the external device 320, and, at the external device 320, encrypting the sensor measurement data using a key to obtain encrypted data, and, transmitting the encrypted data. The transmitting may, for example, be performed wirelessly WL3 or conductively Cl.
In the examples or embodiments transmitting data from or to the implantable system 10, the following method may be implanted in order to verify the integrity of the data, described with reference to figs. 57A - 57C. By verifying the integrity of the data, an external device 320 or a processor 306 comprised in the controller 300 may verify that the data has not been corrupted or tampered with during the transmission. In some examples, data integrity for data communicated between a controller 300 and an external device 320 or between an external device 320 and the controller 300 may be performed using a cyclic redundancy check.
Thus, in a first example, a method for evaluating a parameter of a controller 300 implanted in a patient is described. The controller 300 comprises a processor 306 and a sensor 606’ for measuring the parameter. The method comprises measuring, using the sensor 606’, the functional parameter to obtain measurement data; establishing a connection between the internal controller 300 and an external device 320 configured to receive data from the implant; determining, by the processor 306, a cryptographic hash or a metadata relating to the measurement data and adapted to be used by the external device 320 to verify the integrity of the received data; transmitting the cryptographic hash or metadata; and transmitting, from the controller 300, the measurement data.
The parameter may, for example, be a parameter of the controller 300, such as a temperature, a pressure, a battery status indicator, a time period length, s pressure at a restriction device, a pressure at a sphincter, or a physiological parameter of the patient, such as a pulse, a blood pressure, or a temperature. In some examples, multiple parameters may be used.
The method may further comprise evaluating the measurement data relating to the functional parameter. By evaluating it may be meant to determine if the parameter is exceeding or less than a predetermined value, to extract another parameter from the measurement data, compare the another parameter to a predetermined value, or displaying the another parameter to a user. For example, the method may further comprise, at the external device 320, to determining, based on the evaluating, that the implantable system 10 is functioning correctly, or determining based on the evaluating that the implantable system 10 is not functioning correctly.
If it is determined that the implantable system 10 is not functioning correctly, the method may further comprise sending, from the external device 320, a corrective command to the controller 300, receiving the corrective command at the controller 300, and by running the corrective command correcting the functioning of the implantable system 10 according to the corrective command.
The method may further comprise, at the external device 320, receiving the transmitted cryptographic hash or metadata, receiving the measurement data, and verifying the integrity of the measurement data using the cryptographic hash or metadata. The cryptographic hash algorithm be any type of hash algorithm, i.e. an algorithm comprising a one-way function configured to have an input data of any length as input and produce a fixed-length hash value. For example, the cryptographic hash algorithm may be MD5, SHA1, SHA 256, etc.
In some examples, the cryptographic hash is a signature obtained by using a private key of the controller 300, and wherein the verifying, by the external device 320, comprises verifying the signature using a public key corresponding to the private key.
When using a cryptographic hash, the method may further comprise calculating a second cryptographic hash for the received measurement data using a same cryptographic hash algorithm as the processor, and determining that the measurement data has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal (i.e. have the same value).
When using a metadata the verifying the integrity of the data may comprises obtaining a second metadata for the received measurement data relating to the functional parameter, and determining that the data has been correctly received based on that metadata and the second metadata are equal. The metadata may, for example, be a length of the data or a timestamp. In some examples the measurement data is transmited in a plurality of data packets. In those examples, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmiting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets.
A similar method may be utilized for communicating instructions from an external device 320 to a controller 300 implanted in a patient. The method comprises establishing a first connection between the external device 320 and the controller 300, establishing a second connection between a second external device 330 and the controller 300, transmiting, from the external device 320, a first set of instructions to the controller 300 over the first connection, transmiting, from the second external device 330, a first cryptographic hash or metadata corresponding to the first set of instructions to the controller 300, and, at the controller 300, verifying the integrity of the first set of instructions and the first cryptographic hash or metadata, based on the first cryptographic hash or metadata. The external device 320 may be separate from the second external device 330.
The first connections may be established between the controller 300 and a transceiver of the external communication unit 323. In some examples, the communication using the second connection is performed using a different protocol than a protocol used for communication using the first communication channel. In some examples, the first connection is a wireless connection and the second connection is an electrical connection. The second connection may, for example, be an electrical connection using the patient’s body as a conductor (using 321). The protocols and ways of communicating may be any communication protocols described in this description with reference to Cl, and WL1-WL4. The establishing of the first and second connections are performed according to the communication protocol used for each of the first and the second connections.
When using a cryptographic hash, the verifying the integrity of the first set of instructions may comprise calculating a second cryptographic hash for the received first set of instructions using a same cryptographic hash algorithm as the processor 306, and determining that the first set of instructions has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal. The cryptographic hash may, for example, be a signature obtained by using a private key of the implantable system 10, and wherein the verifying comprises verifying the signature using a public key corresponding to the private key. In some examples, the cryptographic hash is a signature obtained by using a private key of the implantable system 10, and wherein the verifying comprises verifying the signature using a public key corresponding to the private key. The private keys and public keys, as well as the exchange or transmital of keys have been described in this description. Alternatively, other well-known methods can be used for transmiting or exchanging a key or keys between the external device 320 and the controller 300.
When using a metadata, and wherein the verifying the integrity of the data may comprise obtaining a second metadata for the received first set of instructions, and determining that the first set of instructions has been correctly received based on that metadata and the second metadata are equal. The metadata may, for example, be any type of data relating to the data to be transmitted, in this example the first set of instructions. For example, the metadata may be a length of the data to be transmitted, a timestamp on which the data was transmitted or retrieved or obtained, a size, a number of packets, or a packet identifier.
In some examples, the controller 300 may transmit data to an external device 320 relating to the data information in order to verify that the received data is correct. The method may thus further comprise, transmitting, by the controller 300, information relating to the received first set of instructions, receiving, by the external device 320, the information, and verifying, by the external device 320, that the information corresponds to the first set of instructions sent by the external device 320. The information may, for example, comprise a length of the first set of instructions.
The method may further comprise, at the controller 300, verifying the authenticity of the first set of instructions by i. calculating a second cryptographic hash for the first set of instructions, ii. comparing the second cryptographic hash with the first cryptographic hash, iii. determining that the first set of instructions are authentic based on that the second cryptographic hash is equal to the first cryptographic hash, and upon verification of the authenticity of the first set of instructions, storing them at the controller 300.
In some examples, the first set of instructions comprises a cryptographic hash corresponding to a previous set of instruction, as described in other parts of this description.
In some examples, the first set of instructions may comprise a measurement relating to the patient of the body for authentication, as described in other parts of this description.
A system and a method for communication of instructions or control signals between an external device 320 and an implantable system 10 will now be described with reference to Figs. 57A - 57C.
The system shown in Figs. 57A - 57C comprises a first external device 320, and a second external device 330. The implantable system 10 comprises a controller 300. The controller 300 is adapted to receive an instruction from an external device 320 over the communication channel WL1, Cl and run the instruction to control a function of the implantable system 10. The communication channel WL1, Cl may be any type of communication channel, such as a wireless connection WL1 or a conductive connection Cl described herein. For example, the wireless connection may comprise at least one of the following protocols: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, a BLE type protocol, a NFC type protocol, a 3G/4G/5G/6G type protocol, a GSM type protocol, and/or Bluetooth 5.
The first external device 320 is adapted to receive, such as through a user interface, or determine an instruction to be transmitted to the implantable system 10. The determination of the instruction may, for example, be based on received data from the implantable system 10, such as measurement data or data relating to a state of the implantable system 10, such as a battery status or a free memory status. The first external device 320 may be any type of device capable of transmitting information to the implantable system 10 and capable of determining or receiving an instruction to be transmitted to the implantable system 10. In a preferred embodiment, the first external device 320 is a hand-held device, such as a smartphone, smartwatch, tablet etc. handled by the patient, having a user interface for receiving an instruction from a user, such as the patient or a caregiver.
The first external device 320 is further adapted to transmit the instruction to a second external device 330 via communication channel WL3. The second external device 320 is adapted to receive the instruction, encrypt the instruction using an encryption key, and then transmit the encrypted instruction to the implantable system 10. The implantable system 10 is configured to receive the instruction at the controller 300. The controller 300 thus comprises a wired transceiver or a wireless transceiver for receiving the instruction. The implantable system 10 is configured to decrypt the received instruction. The decryption may be performed using a decryption key corresponding to the encryption key. The encryption key, the decryption key and methods for encryption/decryption and exchange of keys may be performed as described in the “general definition of features” or as described with reference to Figs. 57A - 57C. Further, there are many known methods for encrypting data which the skilled person would understand to be usable in this example.
The second external device 330 may be any computing device capable of receiving, encrypting and transmitting data as described above. For example, the second external device 320 may be a network device, such as a network server, or it may be an encryption device communicatively coupled to the first external device.
The instruction may be a single instruction for running a specific function or method in the implantable system 10, a value for a parameter of the implantable system 10, or a set of sub-steps to be performed by the controller 300 comprised in the implantable system 10.
In this way, the instruction for controlling a function of the implantable system 10 may be received at the first external device 320 and transmitted to the implantable system 10 via the second external device 330. By having a second external device 330 encrypting the instruction before transmitting it to the implantable system 10, the instruction may be verified by the second external device 330 and the first external device 320 may function so as to relay the instruction. In some alternatives, the second external device 330 may transmit the instruction directly to the implantable system 10. This may provide an increased security as the instruction sent to the implantable system 10 may be verified by the second external device 330, which, for example, may be a proprietary device managed by the medical professional responsible for the implantable system 10. Further, by having the second external device 330 verifying and encrypting the instruction, the responsibility authenticity and/or correctness of the instruction may he with the second external device 330, which may be beneficial for regulatory purposes, as the first external device 320 may not be considered as the instructor of the implantable system 10. Further, the second external device 330 may verify that the instruction is correct before encrypting or signing and transmitting it to the implantable system 10. The second external device 330 may, for example, verify that the instruction is correct by comparing the instruction with a predetermined set of instructions, and if the instruction is comprised in the predetermined set of instructions determine that the instruction is correct. If the instruction comprises a plurality of substeps, the second external device 330 may determine that the instruction is correct if all the substeps are comprised in the predetermined set of instructions. If the instruction comprises a value for a parameter of the implantable system 10, the second external device 330 may verify that the value is within a predetermined range for the parameter. The second external device 320 may thus comprise a predetermined set of instructions, or a predetermined interval or threshold value for a value of a parameter, stored at an internal or external memory.
The second external device 330 may be configured to reject the instruction, i.e. to not encrypt and transmit the instruction to the implantable system 10, if the verification of the instruction would fail. For example, the second external device 330 determines that the instruction or any sub-step of the instruction is not comprised in the predetermined set of instructions, or if a value for a parameter is not within a predetermined interval, the second external device 330 may determine that the verification has failed.
In some embodiments, the implantable system 10 may be configured to verify the instruction. The verification of the instruction may be performed in the same way as described with reference to Figs. 57A - 57C. If the verification is performed by comparing the instruction or any sub-steps of the instruction with a predetermined set of instructions, the controller 300 may comprise a predetermined set of instructions. The predetermined set of instructions may, for example, be stored in an internal memory of the controller 300. Similarly, the controller 300 may store predetermined reference intervals for any parameter that can be set, and the controller 300 may be configured to compare a received value for a parameter to such a predetermined reference interval. If the verification of the instruction would fail, the controller 300 may be configured to reject the instruction, i.e. not run the instruction.
In an alternative to encrypting and decrypting the instruction, the instruction may be signed by the second external device 330 using a cryptographic hash, and the controller 300 may be configured to verify that the signature is correct before running the instruction.
A corresponding method for transmitting an instruction will now be described with reference to Figs. 65a - 65c. The instruction may relate to a function of the implantable system 10, such as an instruction to run a function or method of the implantable system 10, or to set a value of a parameter of the implantable system 10. The method comprises: transmitting an instruction for the implantable system 10 from the first external device 300 to a second external device 320, the instruction relating to a function of the implantable system 10, encrypting, at the second external device 330 using a first encryption key, the instruction into an encrypted instruction, and transmitting the encrypted instruction from the second external device 330 to the implantable system 10, decrypting, at the implantable system 10, the instructions using a second encryption key corresponding to the first encryption key. The steps performed by or at the implantable system 10 may be executed by the controller 300.
The instruction may be any type of instruction for controlling a function of the implantable system 10. For example, the instruction may be an instruction to run a function or method of the implantable system 10 or controller 300, an instruction comprising a plurality of sub-steps to be run at the controller 300, or a value for a parameter at the controller 300. The first external device 320 may, for example, receive the instruction from a user via a user interface displayed at or connected to the first external device 320. In another example, the first external device 320 may determine the instruction in response to data received from the implantable system 10, such as measurement data, or from another external device. Thus, in some examples, the method may further comprise receiving, at the first external device 320, an instruction to be transmitted to the implantable system 10. The method may further comprise displaying a user interface for receiving the instruction. In another example, the method comprises determining, at the first external device 320, an instruction to be transmitted to the implantable system 10.
In some embodiments, the transmitting of the encrypted instruction from the second external device 330 to the implantable system 10 comprises transmitting the encrypted instruction from the second external device 330 to the first external device 320, and transmitting the encrypted instruction from the first external device 320 to the controller 300 of the implantable system 10. In other words, the first external device 320 may relay the encrypted instruction from the second external device 330 to the controller 300, preferably without decrypting the instruction before transmitting it.
The method may further comprise, at the controller 300, running the instruction or performing the instruction. The running of the instruction may be performed by an internal computing unit or a processor 306 comprised in the controller 300, and may, for example, cause the internal computing unit or processor 306 to instruct the implantable medical device 302 to perform an action.
The method may further comprise verifying, at the second external device 330, that the instructions are correct. The verifying may be performed as described above with reference to the corresponding system.
The method may further comprise verifying, at the controller 300, that the instructions are correct. The verifying may be performed as described above with reference to the corresponding system. The method may further comprise authenticating the connection between the first external device 320 and the controller 300 over which the encrypted instruction is to be transmitted. The authentication may be
As described above, a control program of the controller 300 may be updatable, configurable or replaceable. A system and a method for updating or configuring a control program of the controller 300 is now described with reference to figs. 57A - 57C. The controller may comprise an internal computing unit 306 configured to control a function of the implantable system 1, the internal computing unit 306 comprises an internal memory 307 configured to store: i. a first control program 310 for controlling the internal computing unit, and ii. a second, configurable or updatable, with predefined program steps, control program 312 for controlling said function of the implantable system 1, and iii. a set of predefined program steps for updating the second control program 312. The controller 300 is configured to communicate with an external device 320. The internal computing unit 306 is configured to receive an update to the second control program 312 via the controller 300, and a verification function of, connected to, or transmitted to the controller 300. The verification function is configured to verify that the received update to the second control program 312 comprises program steps comprised in the set of predefined program steps. In this way, the updating or programming of the second control program may be performed using predefined program steps, which may decrease the risk that the new or updated control program is incorrect or comprises malicious software, such as a virus, spyware or a malware.
The predefined program steps may comprise setting a variable related to a pressure, a time, a minimum or maximum temperature, a current, a voltage, an intensity, a frequency, an amplitude of electrical stimulation, a feedback mode (sensorics or other), a post-operative mode or a normal mode, a catheter mode, a fibrotic tissue mode (for example semi-open), an time open after urination, a time open after urination before bed-time.
The verification function may be configured to reject the update in response to the update comprising program steps not comprised in the set of predefined program steps and/or be configured to allow the update in response to the update only comprising program steps comprised in the set of predefined program steps.
The internal computing unit 306 may be configured to install the update in response to a positive verification, for example by a user using an external device, by a button or similarly pressed by a user, or by another external signal.
The authentication or verification of communications between the implant and an external device has been described above.
When updating a control program of the controller 300, it may be beneficial to transmit a confirmation to a user or to an external device or system. Such a method is now described with reference to figs. 57A - 57C. The method for updating a control program of a controller 300 comprised in the implantable system lOaccording to any of the embodiments herein. The controller 300 is adapted for communication with a first external device 320 and a second external device 330, which may comprise receiving, by the internal computing unit, an update or configuration to the control program from the first external device, wherein the update is received using a first communication channel; installing, by the internal computing unit 306, the update; and transmitting, by the internal computing unit, logging data relating to the receipt of the update or configuration and/or logging data relating to an installation of the update to the second external device 330 using the second communication channel; wherein the first and the second communication channels are different communication channels. By using a first and a second communication channels, in comparison to only using one, the security of the updating may be improved as any attempts to update the control program will be logged via the second communication channel, and thus, increasing the chances of finding incorrect or malicious update attempts.
The update or configuration comprises a set of instructions for the control program, and may, for examples comprise a set of predefined program steps as described above. The configuration or update may comprise a value for a predetermined parameter.
In some examples, the method further comprises confirming, by a user or by an external control unit, that the update or configuration is correct based on the received logging data.
The logging data may be related to the receipt of the update or configuration, and the controller 300 is configured to install the update or configuration in response to receipt of a confirmation that the logging data relates to a correct set of instructions. In this way, the controller 300 may receive data, transmit a logging entry relating to the receipt, and then install the data in response to a positive verification that the data should be installed.
In another example, or in combination with the one described above, the logging data is related to the installation or the update or configuration. In this example the logging data may be for information purposes only and not affect the installation, or the method may further comprise activating the installation in response to the confirmation that the update or configuration is correct.
If the update or configuration is transmitted to the controller 300 in one or more steps, the verification as described above may be performed for each of the steps.
The method may further comprise, after transmitting the logging data to the second external device, verifying the update via a confirmation from the second external device 330 via the second communication channel.
With reference to Fig. 57A - 57C there may further be provided an implantable controller 300. The controller 300 is connected to a sensor 351 wherein the sensor 351 is at least one microphone sensor 351 configured to record acoustic signals. For instance, the controller 300 may be configured to register a sound related to at least one of a bodily function of the patient and a function of the implantable system 1. The controller 300 comprises a computing unit 306 configured to derive at least one of a pulse of the patient from the registered sound related to a bodily function, such as information related to the patient swallowing, from the registered sound related to a bodily function. In the alternative, the controller 300 could be configured to derive information related to a functional status of the implantable system lOfrom the registered sound, such as RPM of the motor. To this end the computing unit 306 may be configured to perform signal processing on the registered sound (e.g. on a digital or analog signal representing the registered sound) so as to derive any of the above mentioned information related to a bodily function of the patient or a function of the implantable system 1. The signal processing may comprise filtering the registered sound signals of the microphone sensor 351.
The implantable controller is placed in an implantable housing for sealing against fluid, and the microphone sensor 351 is placed inside of the housing. Accordingly, the controller and the microphone sensor 351 do not come into contact with bodily fluids when implanted which ensures proper operation of the controller and the microphone sensor 351.
In some implementations, the computing unit 306 is configured to derive information related to the functional status of an active unit 302 of the implantable system 10, from the registered sound related to a function of the implantable system 10. Accordingly, the computing unit 306 may be configured to derive information related to the functional status of at least one of: a motor, a pump and a transmission of the active unit 302 of the implantable system 10, from the registered sound related to a function of the implantable system 10.
The controller may comprise a transceiver 303,308 configured to transmit a parameter derived from the sound registered by the at least one microphone sensor 351 using the transceiver 303,308. For example, the transceiver 303,308 is a transceiver configured to transmit the parameter conductively (303) to an external device 320 or wirelessly (308) to an external device 320.
A method of authenticating the implantable system 10, the external device 320 or a communication signal or data stream between the external device 320 and the implantable system 10 is also described with reference to figs. 57A - 57C. The method comprises the steps of registering a sound related to at least one of a bodily function and a function of the implantable system 10, using the at least one microphone sensor 351, connected to the controller 300. The method could in a first authentication embodiment comprise transmitting a signal derived from the registered sound, using the transceiver 303,308, receiving the signal in the external device 320, using the receiver 323,328 and comparing, in the external device 320, a parameter derived from the received signal with a reference parameter, using the computing unit 306. The method could in a second authentication embodiment comprise receiving a signal in the controller 300, from the external device 320, using the transceiver 323,328 and deriving a reference parameter from the received signal, using the computing unit 306 of the controller 300, and comparing, in the controller 300, a parameter derived from the received signal with the derived reference parameter, using the computing unit 306 of the controller 300. The methods further comprise the steps of the implantable controller 300 authenticating the external device 320, or the external device 320 authenticating the implantable controller 300, on the basis of the comparison. The registered sound could for example be related to the patient eating.
Embodiments relating to an implantable system 10 having a controller 300 having a processor 306 with a sleep mode and an active mode will now be described with reference to Fig. 65d. The implant, the internal communication unit and the external device(s) may have the features described above with reference to figs. 57A - 57C.
In an embodiment in which the controller 300 comprises a processor 306 having a sleep mode and an active mode, the controller 300 comprises or is connected to a sensor 606’ and a processing unit 306 having a sleep mode and an active mode. The sensor 606’ is configured to periodically measure a physical parameter of the patient, and the controller 300 is further configured to, in response to a sensor measurement preceding a predetermined value, setting the processing unit 306 in an active mode. That is, the controller 300 may “wake up” or be set in an active mode in response to a measurement from, for example, the body. A physical parameter of the patient could for example be a local or systemic temperature, saturation/oxygenation, blood pressure or a parameter related to an ischemia marker such as lactate.
By sleeping mode it is meant a mode with less battery consumption and/or processing power used in the processing unit 306, and by “active mode” it may be meant that the processing unit 306 is not restricted in its processing.
The sensor 606’ may, for example, be a pressure sensor. The pressure sensor may be adapted to measure a pressure in an organ of a patient, a reservoir of the implant or a pressure exerted by at least one member. The sensor 606’ may be an analog sensor or a digital sensor, i.e. a sensor 606’ implemented in part in software. In some examples, the sensor 606’ is adapted to measure one or more of a battery or energy storage status of the implantable system 10 and a temperature of the implantable system 10. In this way, the sensor 150 may periodically sense a pressure of the implantable system 10 or of the patient, and set the processing unit 306 in an active mode if the measured pressure is above a predetermined value. Thus, less power, i.e. less of for example a battery or energy storage comprised in the implant, may be used, thereby prolonging the lifetime of the implantable system 10 or increasing the time between charging occasions of the implantable system 10.
In some examples, the processor 306, when in set in the active mode, may cause a sensation generator 381 connected to the implant, comprised in the implantable system 10 or comprised in an external device 320, 330, to generate a sensation detectable by a sense of the patient. For example, the processor may cause the sensation generator to generate a sensation in response to a measure battery status, for example that the battery is above or below a predetermined level, that a measured pressure is above or below a predetermined level, or that another measured parameter has an abnormal value, i.e. less than or exceeding a predetermined interval or level. The sensation generator has been described in further detail earlier in this description.
The processing unit 306 may be configured to perform a corrective action in response to a measurement being below or above a predetermined level. Such a corrective action may, for example, be increasing or decreasing a pressure, increasing or decreasing electrical stimulation, increasing or decreasing power.
The controller 300 may comprise a signal transmitter 320 connected to the processing unit, and wherein the processing unit is configured to transmit data relating to the measurement via the transceiver 308 of the controller 300 or an additional internal signal transmitter 392. The transmitted data may be received by an external device 320.
The external device may have an external communication unit 390. The external device 320 may comprise a signal provider 380 for providing a wake signal to the controller 300. In some examples, the signal provider comprises a coil or magnet 371 for providing a magnetic wake signal.
The controller 300 may implement a corresponding method for controlling an implantable system 10 when implanted in a patient. The method comprises measuring, with a sensor of the controller 300 connected to or comprised in the controller 300, a physiological parameter of the patient or a parameter of the implantable system 10, and, in response to a sensor measurement having an abnormal value, setting, by the controller 300, a processor 306 of the controller 300 from a sleep mode to an active mode. The measuring may be carried out periodically. By “abnormal value” it may be meant a measured value exceeding or being less than a predetermined value, or a measured value being outside a predetermined interval. The method may further comprise generating, with a sensation generator 381 as described above, a sensation detectable by the patient. In some examples, the generating comprises requesting, by the processor, the sensation generator 381 to generate the sensation.
The method may further comprise to perform a medical intervention in response to a sensor measurement having an abnormal value, preferably after the processing unit has been set in the active mode.
According to one embodiment described with reference to fig. 57A - 57C, the communication unit or internal controller 300 or control unit 300 comprises a wireless transceiver 308 for communicating wirelessly with an external device, a security module 389, and a central unit, also referred to herein as a computing unit 306, which is to be considered as equivalent. The central unit 306 is configured to be in communication with the wireless transceiver 308, the security module 389 and the vessel member 100. The wireless transceiver 308 is configured to receive communication from the external device 320 including at least one instruction to the implantable system 10 and transmit the received communication to the central unit or computing unit 306. The central unit or computing unit 306 is configured to send secure communication to the security module 389, derived from the received communication from the external device 200, and the security module 389 is configured to decrypt at least a portion of the secure communication and verify the authenticity of the secure communication. The security module is further configured to transmit a response communication to the central unit or computing unit 306 and the central unit or computing unit is configured to communicate the at least one instruction to the vessel member 100. In the embodiment shown in fig. 57A - 57C, the at least one instruction is based on the response communication, or a combination of the response communication and the received communication from the external device 320.
In the embodiment shown in fig. 57A - 57C, the security module 389 comprises a set of rules for accepting communication from the central unit or computing unit 306. In the embodiment shown in fig. 57A - 57C, the wireless transceiver 308 is configured to be able to be placed in an off-mode, in which no wireless communication can be transmitted or received by the wireless transceiver 308. The set of rules comprises a rule stipulating that communication from the central unit or computing unit 306 to the security module 389 or to the vessel member 100 is only accepted when the wireless transceiver 308 is placed in the off-mode.
In the embodiment shown in fig. 57A - 57C, the set of rules comprises a rule stipulating that communication from the central unit or computing unit 306 is only accepted when the wireless transceiver 308 has been placed in the off-mode for a specific time period.
In the embodiment shown in fig. 57A - 57C, the central unit or computing unit 306 is configured to verify a digital signature of the received communication from the external device 320. The digital signature could be a hash-based digital signature which could be based on a biometric signature from the patient or a medical professional. The set of rules further comprises a rule stipulating that communication from the central unit 306 is only accepted when the digital signature of the received communication has been verified by the central unit 306. The verification could for example comprise the step of comparing the digital signature or a portion of the digital signature with a previously verified digital signature stored in the central unit 306. The central unit 306 may be configured to verify the size of the received communication from the external device and the set of rules could comprise a rule stipulating that communication from the central unit 306 is only accepted when the size of the received communication has been verified by the central unit 306. The central unit could thus have a rule stipulating that communication above or below a specified size range is to be rejected.
In the embodiment shown in fig. 57A - 57C, the wireless transceiver is configured to receive a message from the external device 320 being encrypted with at least a first and second layer of encryption. The central unit 306 the decrypts the first layer of decryption and transmit at least a portion of the message comprising the second layer of encryption to the security model 389. The security module 389 then decrypts the second layer of encryption and transmits a response communication to the central unit 306 based on the portion of the message decrypted by the security module 389.
In the embodiment shown in fig. 57A - 57C, the central unit 306 is configured to decrypt a portion of the message comprising a digital signature, such that the digital signature can be verified by the central unit 306, also the central unit 306 is configured to decrypt a portion of the message comprising message size information, such that the message size can be verified by the central unit 306.
In the embodiment shown in fig. 57A - 57C, the central unit 306 is configured to decrypt a first and second portion of the message, and the first portion comprises a checksum for verifying the authenticity of the second portion.
In the embodiment shown in fig. 57A - 57C, the response communication transmitted from the security module 389 comprises a checksum, and the central unit 306 is configured to verify the authenticity of at least a portion of the message decrypted by the central unit 306 using the received checksum, i.e. by adding portions of the message decrypted by the central unit 306 and comparing the sum to the checksum.
In the embodiment shown in fig. 57A - 57C, the set of rules further comprise a rule related to the rate of data transfer between the central unit 306 and the security module 389. The rule could stipulate that the communication should be rejected or aborted if the rate of data transfer exceeds a set maximum rate of data transfer, which may make it harder for unauthorized persons to inject malicious code or instructions to the medical implant.
In the embodiment shown in fig. 57A - 57C, the security module 389 is configured to decrypt a portion of the message comprising the digital signature being encrypted with the second layer of encryption, such that the digital signature can be verified by the security module 389. The security module 389 then transmits a response communication to the central unit 306 based on the outcome of the verification, which can be used by the central unit 306 for further decryption of the message or for determining if instructions in the message should be communicated to the vessel member 100.
In the embodiment shown in fig. 57A - 57C, the central unit 306 is only capable of decrypting a portion of the received communication from the external device 320 when the wireless transceiver 308 is placed in the off-mode. In the alternative, or as an additional layer of security, the central unit 306 may be limited such that the central unit 306 is only capable of communicating instructions to the vessel member 100 of the implantable system 10 when the wireless transceiver 308 is placed in the off-mode. This ensures that no attacks can take place while the central unit 306 is communicating with the active unit 301.
In the embodiment shown in fig. 57A - 57C, the implantable controller 300 is configured to receive, using the wireless transceiver 308, a message from the external device 320 comprising a first un-encrypted portion and a second encrypted portion. The implantable controller 300 (e.g. the central unit 306 or the security module 389) then decrypts the encrypted portion, and uses the decrypted portion to verify the authenticity of the un-encrypted portion. As such, computing power and thereby energy can be saved by not encrypting the entire communication, but rather only the portion required to authenticate the rest of the message (such as a checksum and/or a digital signature)
In the embodiment shown in fig. 57A - 57C, the central unit 306 is configured to transmit an encrypted portion to the security module 389 and receive a response communication from the security module 389 based on information contained in the encrypted portion being decrypted by the security module. The central unit 306 is then configured to use the response communication to verify the authenticity of the un-encrypted portion. The un-encrypted portion could comprise at least a portion of the at least one instruction to the implantable medical device 306.
In the embodiment shown in fig. 57A - 57C, the implantable controller 300 is configured to receive, using the wireless transceiver 308, a message from the external device 320 comprising information related to at least one of: a physiological parameter of the patient and a physical or functional parameter of the implanted system 10, and use the received information to verify the authenticity of the message. The physiological parameter of the patient could be a parameter such as a parameter based on one or more of: a temperature, a heartrate and a saturation value.
The physical or functional parameter of the implanted system 10 could comprise at least one of a current setting or value of the vessel member 100, a prior instruction sent to the implantable system 10 or an ID of the implanted system 10.
The portion of the message comprising the information related to the physiological parameter of the patient and/or physical or functional parameter of the implanted system 10 could be encrypted, and the central unit 306 may be configured to transmit the encrypted portion to the security module 389 and receive a response communication from the security module 389 based on the information having been decrypted by the security module 389.
In the embodiment shown in fig. 57A - 57C, the security module 389 is a hardware security module comprising at least one hardware-based key. The security module 389 may have features that provide tamper evidence such as visible signs of tampering or logging and alerting. It may also be so that the security module 389 is “tamper resistant”, which makes the security module 389 inoperable in the event that tampering is detected. For example, the response to tampering could include deleting keys is tampering is detected. The security module 389 could comprise one or more secure cryptoprocessor chip. The hardware-based key(s) in the security module 389 could have a corresponding hardware-based key placeable in the external device 320. The corresponding external hardware-based key could be placed on a key-card connectable to the external device 320.
In alternative embodiments, the security module 389 is a software security module comprising at least one software-based key, or a combination of a hardware and software-based security module and key. The software-based key may correspond to a software-based key in the external device 320. The software-based key may correspond to a software-based key on a keycard connectable to the external device 320.
In the embodiment shown in fig. 57A - 57C, the external device 320 is a handheld external device, however, in alternative embodiments, the external device may be a remote external device or a cloud based external device
In the embodiment shown in fig. 57A - 57C, the at least one instruction to the implantable system 10 comprises an instruction for changing an operational state of the implantable system 10, including an operational state of the vessel member 100.
In the embodiment shown in fig. 57A - 57C, the wireless transceiver 308 is configured to communicate wirelessly with the external 320 device using electromagnetic waves at a frequency below 100 kHz, or more specifically below 40 kHz. The wireless transceiver 308 is thus configured to communicate with the external device 320 using “Very Low Frequency” communication (VLF). VLF signals have the ability to penetrate a titanium housing of the implantable system 10, such a titanium housing of the remote unit, such that the electronics of the implantable system 10 can be completely encapsulated in a titanium housing.
The wireless transceiver 308 is configured to communicate wirelessly with the external device 320 using a first communication protocol and the central unit 306 is configured to communicate with the security module 389 using a second, different, communication protocol. This adds an additional layer of security as security structures could be built into the electronics and/or software in the central unit 306 enabling the transfer from a first to a second communication protocol. The wireless transceiver 308 may be configured to communicate wirelessly with the external device using a standard network protocol, which could be one of an RFID type protocol, a WLAN type protocol, a Bluetooth (BT) type protocol, a BLE type protocol, an NFC type protocol, a 3G/4G/5G type protocol, and a GSM type protocol. In the alternative, or as a combination, the wireless transceiver 308 could be configured to communicate wirelessly with the external device 320 using a proprietary network protocol. The wireless transceiver 308 could comprises a Ultra- Wide Band (UWB) transceiver and the wireless communication between the implantable controller 300 and the external device 320 could thus be based on UWB. The use of UWB technology enables positioning of the external device 320 which can be used by the implanted system 10 as a way to establish that the external device 320 is at a position which the implanted system 10 and/or the patient can acknowledge as being correct, e.g. in the direct proximity to the implanted system 10 and/or the patient, such as within reach of the patient and/or within 1 or 2 meters of the implanted system 10. In the alternative, a combination of UWB and BT could be used, in which case the UWB communication can be used to authenticate the BT communication, as it is easier to transfer large data sets using BT.
According to one embodiment described with reference to fig. 57A - 57C, the controller 300 of the implantable system 10 comprises a receiving unit 305 or energy receiver 305 comprising a coil 192 (specifically shown in fig. 57B’) configured for receiving transcutaneously transferred energy. The receiving unit 305 further comprises a measurement unit 194 configured to measure a parameter related to the energy received by the coil 192 and a variable impedance 193 electrically connected to the coil 192. The receiving unit 305 further comprises a switch 195a placed between the variable impedance 193 and the coil 192 for switching off the electrical connection between the variable impedance 193 and the coil 192. The controller 300 is configured to control the variable impedance 193 for varying the impedance and thereby tune the coil 192 based on the measured parameter. The controller 300 is further configured to control the switch 195a for switching off the electrical connection between the variable impedance 193 and the coil 192 in response to the measured parameter exceeding a threshold value. The controller 300 may further be configured to vary the variable impedance in response to the measured parameter exceeding a threshold value. As such, the coil can be tuned or switched off to reduce the amount of received energy if the amount of received energy becomes excessive. The measurement unit 194 is configured to measure a parameter related to the energy received by the coil 192 over a time period and/or measure a parameter related to a change in energy received by the coil 192 by for example measure the derivative of the received energy over time. The variable impedance 193 is in the embodiment shown in fig. 57B’ placed in series with the coil 192. In alternative embodiments it is however conceivable that the variable impedance is placed parallel to the coil 192.
The first switch 195a is placed at a first end portion 192a of the coil 192, and the receiving unit 305 further comprises a second switch 195b placed at a second end portion of the coil 192, such that the coil 192 can be completely disconnected from other portions of the implantable system 10. The receiving unit 305 is configured to receive transcutaneously transferred energy in pulses according to a pulse pattern. The measurement unit 194 is in the embodiment shown in fig. 57B’ configured to measure a parameter related to the pulse pattern. The controller 300 is configured to control the variable impedance in response to the pulse pattern deviating from a predefined pulse pattern. The controller 300 is configured to control the switch 195a for switching off the electrical connection between the variable impedance 193 and the coil 192 in response to the pulse pattern deviating from a predefined pulse pattern. The measurement unit is configured to measure a temperature in the implantable system 10 or in the body of the patient, and the controller 300 is configured to control the first and second switch 195a, 195b in response to the measured temperature.
The variable impedance 193 may comprise a resistor and a capacitor and/or a resistor and an inductor and/or an inductor and a capacitor. The variable impedance 193 may comprise a digitally tuned capacitor or a digital potentiometer. The variable impedance 193 may comprise a variable inductor. The first and second switch comprises a semiconductor, such as a MOSFET. The variation of the impedance is configured to lower the active power that is received by the receiving unit. As can be seen in fig. 57B’, the variable impedance 193, the first and second switch 195a, 195b and the measurement unit 194 are connected to the communication unit/controller 300 and the receiving unit 305 is connected to an energy storage unit 40 such that the energy storage unit 40 can store energy received by the receiving unit 305.
A system comprising an implantable system 10 having a controller 300 having a sleep mode and an active mode will now be described with reference to Fig. 57D. In one embodiment, the controller 300 comprises a sensor 150 adapted to detect a magnetic field and a processing unit 306 having a sleep mode and an active mode, now described with reference to figs. 57A - 57D. The external control unit 320 comprises a signal provider 380 adapted to provide a magnetic field detectable by the internal sensor 150. The controller 300 is further configured to, in response to a detected magnetic field exceeding a predetermined value, setting the processing unit 306 in an active mode. In this way, the external device 320 may cause a sleeping controller 300 or processor 306 to “wake up”.
The sensor 150 may, for example, be a hall effect sensor, a fluxgate sensor, an ultrasensitive magnetic field sensor, a magneto-resistive sensor, an AMR or GMR sensor, or the sensor may comprise a third coil having an iron core.
The magnetic field provider 380 may have an off state, wherein it does not provide any magnetic field, and an on state, wherein it provides a magnetic field. For example, the magnetic field provider 380 may comprise a magnet 371, a coil 371, a coil having a core 371, or a permanent magnet 371. In some embodiments, the magnetic field provider 380 may comprise a shielding means for preventing a magnet 371 or permanent magnet 371 from providing a magnetic field in the off state. In order to provide a substantially even magnetic field, the magnetic field provider may comprise a first and a second coil arranged perpendicular to each other.
After the processing unit 306 has been set in an active mode, i.e. when the processing unit 306 has been woken, the implant may determine a frequency for further communication between the controller 300 and the external device 320. The controller 300 may thus comprise a frequency detector 391 for detecting a frequency for communication between the controller 300 and the second communication unit 390. The frequency detector 391 is, for example, an antenna. The external device 320 may comprise a frequency indicator 372, for transmitting a signal indicative of a frequency. The frequency indicator 372, may, for example, be a magnetic field provider capable of transmitting a magnetic field with a specific frequency. In some examples the frequency indicator is comprised in or the same as the magnetic field provider 371. In this way, the frequency signal is detected using means separate from the sensor, and can, for example, be detected using a pin on a chip.
Alternatively, the controller 300 and the external device 320 may communicate using a predetermined frequency or a frequency detected by means defined by a predetermined method according to a predetermined protocol to be used for the communication between the controller 300 and the external device 320. In some embodiments, the sensor 150 may be used for the communication. The communication may in these embodiments be performed with such that a frequency of the magnetic field generated by the coil is 9-315 kHz, or the magnetic field generated by the coil is less than or equal to 125kHz, preferably less than 58kHz. The frequency may be less than 50Hz, preferably less than 20Hz, more preferably less than 10Hz, in order to be transmittable through a titanium box.
In some embodiments, the controller 300 comprises a receiver unit 392, and the internal controller and the external control unit are configured to transmit and/or receive data via the receiver unit 392 via magnetic induction. The receiver unit 392 may comprise a high-sensitivity magnetic field detector, or the receiver unit may comprise a fourth coil for receiving the magnetic induction.
The system may implement a method for controlling an implantable system 10. The method comprises monitoring for signals by a sensor 150 comprised in the controller 300 communicatively coupled to the active unit 302, providing, from a signal provider 380 comprised in an external device 320, a wake signal, the external device 320 being adapted to be arranged outside of the patient’s body, and setting, by the controller 300 and in response to a detected wake signal WS, a mode of a processing unit 306 comprised in the internal controller from a sleep mode to an active mode.
The method may also comprise detecting, using a frequency detector 391, a frequency for data communication between the controller 300 and a second communication unit 390 being associated with the external device 320. The frequency detector 391 is communicatively coupled to the controller 300 or the external device 320. The detection may be performed using a detection sequence for detecting the frequency. This detection sequence may, for example, be a detection sequence defined in the protocol to be used for communication between the controller 300 and the second communication unit 390. Potential protocols that may be used for communication between the controller 300 and the external device 320 has been described earlier in this description. Thus, the method may comprise determining, using the frequency detector 391, the frequency for data communication, and initiating data communication between the controller 300 and the second communication unit 390. The data communication can, for example, comprise one or more control instructions for controlling the implantable system 10 transmitted from the external device 320, or, for example, comprise data related to the operation of the implantable system 10 and be transmitted from the controller 300.
In some examples, the implantable system 10 may comprise or be connected to a power supply for powering the implantable system 10. This will now be described with reference to fig. 57E. The implantable system 10, the internal controller, and the external device(s) may comprise all elements described above with reference to figs. 57A - 57C and fig. 57D. The power supply may comprise an implantable energy storage unit 40 for providing energy to the implantable system 10, an energy provider 397 connected to the implantable energy storage unit 40 and connected to an energy consuming part of the implantable system 10, the energy provider 397 being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider 397 is configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical power during startup of the energy consuming part.
Alternatively, the implantable system 10 may comprise a first implantable energy storage unit 40 for providing energy to an energy consuming part of the implantable system 10, a second implantable energy storage unit 397 connected to the implantable energy storage unit 40 and connected to the energy consuming part, wherein the second implantable energy storage unit 397 is configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical power during startup of the energy consuming part. The second implantable energy storage unit 397 has a higher energy density than the first implantable energy storage unit 40. By having a “higher energy density” it may be meant that the second implantable energy storage unit 397 has a higher maximum energy output per time unit than the first implantable energy storage unit 40. The second energy storage 397 may be an energy provider as discussed below.
The energy consuming part may be any part of the implantable system 10, such as a motor for powering the hydraulic pump, a valve, a processing or computing unit, a communication unit, a device for providing electrical stimulation to a tissue portion of the body of the patient, a CPU for encrypting information, a transmitting and/or receiving unit for communication with an external unit (not shown as part of the energy consuming part in the drawings, that is, the communication unit may be connected to the energy storage unit 40 and to the energy provider 397), a measurement unit or a sensor, a data collection unit, a solenoid, a piezo-electrical element, a memory metal unit, a vibrator, a part configured to operate a valve comprised in the system 10, or a feedback unit.
In this way, an energy consuming part requiring a quick start or an energy consuming part which requires a high level or burst of energy for a start may be provided with sufficient energy. This may be beneficial as instead of having an idle component using energy, the component may be completely turned off and quickly turned on when needed. Further, this may allow the use of energy consuming parts needing a burst of energy for a startup while having a lower energy consumption when already in use. In this way, a battery or an energy storage unit having a slower discharging (or where a slower discharging is beneficial for the lifetime or health of the battery) may be used for the implant, as the extra energy needed for the startup is provided by the energy provider.
Energy losses may occur in a battery or energy storage unit of an implant if the battery or energy storage unit is discharged too fast. These energy losses may for example be in the form of heat, which may damage the battery or energy storage unit. By the apparatus described in these examples, energy may be provided from the battery or energy storage unit in a way that does not damage the battery or energy storage unit, which may improve the lifetime of the battery or energy storage unit and thereby the lifetime of the system 10.
In some examples, the discharging from the implantable energy storage unit 40 during startup of the energy consuming part is slower than the energy needed for startup of the energy consuming part, i.e. the implantable energy storage unit 40 is configured to have a slower discharging than the energy needed for startup of the energy consuming part. That is, there is a difference between the energy needed by the energy consuming part and the energy the implantable energy storage unit 40 is capable of providing without damaging the implantable energy storage unit 40. In other words, a maximum energy consumption of the energy consuming part may be higher than the maximum energy capable of being delivered by the implantable energy storage unit 40 without causing damage to the implantable energy storage unit, and the energy provider 397 may be adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy storage unit 40. The implantable energy storage unit 40 may be configured to store a substantially larger amount of energy than the energy burst provider 397, but may be slower to charge.
The implantable energy storage unit 40 may be any type of energy storage unit suitable for an implantable system 10, such as a re-chargeable battery or a solid-state battery, such as a tionyl- chlorid battery. The implantable energy storage unit 40 may be connected to the energy consuming part and configured to power the energy consuming part after it has been started using the energy provider 397.
The energy provider 397 may be any type of part configured to provide a burst of energy for the energy consuming part. In some examples, the energy provider 397 is a capacitor, such as a start capacitor, a run capacitor, a dual run capacitor or a supercapacitor. The energy provider 397 may be connected to the implantable energy storage unit 40 and be adapted to be charged using the implantable energy storage unit 40. In some examples, the energy provider may be a second energy provider 397 configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical energy. The implantable system 10 may further comprising a temperature sensor for sensing a temperature of the capacitor and the temperature sensor may be integrated or connected to the controller 300 such that the sensed temperature can be used as input for controlling the implantable system 10 or as feedback to be sent to an external device 320.
A corresponding method for powering a medical device may also be contemplated. The method comprises the steps of initiating an energy consuming part 302 of the implant, the energy consuming part being connected to an implantable energy storage unit 40, providing an initial burst of energy to the energy consuming part using an energy provider 397 connected to the implantable energy storage unit 40 and to the energy consuming part 302, the energy provider 397 being adapted to provide a burst of energy to the energy consuming part, and subsequently powering the energy consuming part 302 using the implantable energy storage unit 40.
In some examples, a maximum energy consumption of the energy consuming part is higher than the maximum energy capable of being delivered by the implantable energy storage unit 40 without causing damage to the implantable energy storage unit 40, and the energy provider 397 is adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy storage unit 40.
The method may further comprise the step of charging the energy provider 397 using the implantable energy storage unit 40.
Initiating an energy consuming part 302may comprise transitioning a controller of the medical device from a sleep mode to an operational or active mode.
The implantable energy storage unit 40 may be adapted to be wirelessly charged and the implantable energy storage unit may be connected to an internal charger 395 for receiving wireless energy from an external device 320 via an external charger 396, and the method may comprise wirelessly charging the implantable energy storage unit 40. In some examples, the method comprises controlling a receipt of electrical power from an external energy storage unit at the internal charger 395. The internal energy storage unit 40 may be charged via the receipt of a transmission of electrical power from an external energy storage unit 396 by the internal charger 395.
The embodiments described herein may advantageously be combined. For example, all the embodiments relating to the communication and controlling of the medical device may be combined with the embodiments relating to the programming of the system 10, the methods and systems for improving energy consumption or the power supply. The embodiments relating to the programming of the system 10 may be combined with any of the embodiments relating to improving the energy consumption or the power supply. The embodiments relating to the power supply maybe combined with the methods and systems for improving the energy consumption.
A computer program product of, or adapted to be run on, an internal computing unit or an external device is also provided, which comprises a computer-readable storage medium with instructions adapted to make the internal computing unit and/or the external device perform the actions as described in any embodiment or example above.
Fig. 57F shows one embodiment of a system for charging, programming and communicating with the controller 300 of the implanted system 10. Fig. 57F further describes the communication and interaction between different external devices which may be devices held and operated by the patient, by the health care provider (HCP) or by the Dedicated Data Infrastructure (DDI), which is an infrastructure supplier for example by the manufacturer of the implanted medical device 100 or the external devices 320’, 320”, 320’”. The system of the embodiment of fig. 57F comprises three external devices 320’, 320”, 320’” capable of communicating with the controller 300.
The basic idea is to ensure the security of the communication with, and the operation of, the system 10 by having three external devices 320’, 320”, 320’” with different levels of authority. The lowest level of authority is given to the patient operated remote control 320”. The remote control, also referred to as external device 320” is authorized to operate functions of the implanted system 10 via the implanted controller 300, on the basis of patient input. The remote control 320” is further authorized to fetch some necessary data from the controller 300. The remote control 320” is only capable of operating the controller 300 by communicating with the software currently running on the controller 300, with the currently settings of the software. The next level of authority is given to the Patient External Interrogation Device (P-EID) 320”’, which is a charging and communication unit which is held by the patient but may be partially remotely operated by the Health Care Provider (HCP) (Usually a medical doctor with the clinic providing the treatment with help of the implanted system 10). The P-EID 320’” is authorized to make setting changes by selecting pre-programmed steps of the software or hardware running on the controller 300 of the implanted system 10. The P-EID is remotely operated by the HCP, and receives input from the HCP, via the DDE
The highest level of authority is given to the HCP-EID 320’ and its controller, referred to as the HCP Dedicated Display Device (DDD). The HCP-EID 320’ is a charging and communication unit which may be located physically at the clinic of the HCP. The HCP-EID 320’ may be authorized to freely alter or replace the software running on the controller 300, when the patient is physically in the clinic of the HCP. The HCP-EID 320’ is controlled by the HCP DDD, which either may act on a “webview” portal from the HCP-EID or be a device closed down to any activities (which may include the absence of an internet connection) other than controlling and communicating with the HCP-EID. The webview portal does not necessarily mean internet based or HTML-protocol and the webview portal may be communicated over other communicating protocols such as Bluetooth or any other type of standard or proprietary protocol. The HCP DDD may also communicate with the HCP-EID over a local network or via Bluetooth or other standard or proprietary protocols.
Starting from the lowest level of authority, the patient remote control external device 320” beneficially may comprise a wireless transceiver 328 for communicating with the implanted system 10. The remote control 320” is capable of controlling the operation of the implanted system 10 via the controller 300, by controlling pre-set functions of the implantable system 10, e.g. for operating an active portion of the implanted system 10 for performing the intended function of the implanted system 10. The remote control 320” is able to communicate with the implanted system 10 using any standard or proprietary protocol designed for the purpose. In the embodiment shown in fig. 57F, the wireless transceiver 328 comprises a Bluetooth (BT) transceiver, and the remote control 320” is configured to communicate with implanted system 10 using BT. In an alternative configurations, the remote control 320” communicates with the implanted system 10 using a combination of Ultra-Wide Band (UWB) wireless communication and BT. The use of UWB technology enables positioning of the remote control 320” which can be used by the implanted system 10 as a way to establish that the remote control 320” is at a position in which the implanted system 10 and/or the patient can acknowledge as being correct, e.g. in the direct proximity to the medical device 100 and/or the patient, such as within reach of the patient and/or within 1 or 2 meters of the implanted system 10.
UWB communication may be performed by the generation of radio energy at specific time intervals and occupying a large bandwidth, thus enabling pulse-position or time modulation. The information can also be modulated on UWB signals (pulses) by encoding the polarity of the pulses, their amplitude and/or by using orthogonal pulses. A UWB radio system can be used to determine the "time of flight" of the transmission at various frequencies. This helps overcome multipath propagation, since some of the frequencies have a line-of-sight trajectory, while other indirect paths have longer delay. With a cooperative symmetric two-way metering technique, distances can be measured at high resolution and accuracy. UWB is useful for real-time location systems, and its precision capabilities and low power make it well-suited for radio-frequency-sensitive environments, such as health care environments.
In embodiments in which a combination of BT and UWB technology is used, the UWB technology may be used for location-based authentication of the remote control 320”, whereas the communication and/or data transfer could take place using BT or any other way of communicating different from the UWB. The UWB signal could in some embodiments also be used as a wake-up signal for the controller 300, or for the BT transceiver, such that the BT transceiver in the implanted system 10 can be turned off when not in use, which eliminates the risk that the BT is intercepted, or that the controller 300 of the implanted system 10 is hacked by means of BT communication. In embodiments in which a BT (or alternatives) / UWB combination is used, the UWB connection may be used also for the transmission of data. In the alternative, the UWB connection could be used for the transmission of some portions of the data, such as sensitive portions of the data, or for the transmission of keys for the unlocking of encrypted communication sent over BT.
The remote control 320” comprises a computing unit 326 configured to run a software application for communicating with the implanted system 10. The computing unit 326 can receive input directly from control buttons 335 arranged on the remote control 320” or may receive input from a control interface 334i displayed on a patient display device 334 operated by the patient. In the embodiments in which the remote control 320” receives input from a control interface 334i displayed on the patient display device 334 operated by the patient, the remote control 320” may transmit the control interface 334i in the form of a web-view portal, i.e. a remote interface running in a sandbox environment on the patient’s display device 334. A sandbox environment is understood as running on the display device 334 but only displaying what is presented from the remote control, and only using a tightly controlled set of commands and resources, such as storage and memory space as well as network access. The ability to inspect the host system and read or write from other input devices connected to the display device 334 may therefore be extremely limited. Any action or command generated by the patient display device may be similar to controlling a webpage. All acting software may be located on the remote control that only displays its control interface onto the patient display unit.
The computing unit 326 may further be configured to encrypt the control interface before transmission to the patient display device 334, and encrypt the control commands before transmission to the implanted system 10. The computing unit 326 is further configured to transform the received user input into control commands for wireless transmission to the implantable system 10.
The patient’s display device 334 could for example be a mobile phone, a tablet or a smart watch. In the embodiment shown in fig. 57f, the patient’s display device 334 communicates with the remote control 320” by means of BT. The control interface 334i in the form of a web-view portal is transmitted from the remote control 320” to the patient’s display device 334 over BT. Control commands in the form of inputs from the patient to the control interface 334i may be transmitted from the patient’s display device 334 to the remote control 320”, providing input to the remote control 320” equivalent to the input that may be provided using the control buttons 335. The control commands created in the patient’s display device 334 may be encrypted in the patient’s display device 334 and transmitted to the remote control 320’ using BT or any other communication protocol.
The remote control may normally not be connected to the DDI or the Internet, thereby increasing security. In addition, the remote control 320” may in one embodiment have its own private key. In a specific embodiment, the remote control 320” may be activated by the patient’s private key for a certain time period. This may activate the function of the patient’s display device and the remote wed-view display portal supplied by the remote control to the patient’s display device.
The patient’s private key may be supplied in a patient private key device compromising a smartcard that may be inserted or provided close to the remote control 320” to activate a permission to communicate with the implant 100 for a certain time period.
The patient’s display device 334 may (in the case of the display device 334 being a mobile phone or tablet) comprise auxiliary radio transmitters for providing an auxiliary radio connection, such as a Wi-Fi or mobile connectivity (e.g. according to the 3G,4G or 5G standards). The auxiliary radio connection(s) may have to be disconnected to enable communication with the remote control 320” . Disconnecting the auxiliary radio connections reduces the risk that the integrity of the control interface 334i displayed on the patient’s display device 334 is compromised, or that the control interface 334i displayed on the patient’s display device 334 is remotely controlled by an unauthorized device or entity.
In alternative embodiments, control commands are generated and encrypted by the patient’s display device and transmitted to the DDI 330. The DDI 330 could either alter the created control commands to commands readable by the remote control 320” before further encrypting the control commands for transmission to the remote control 320”, or could simply add an extra layer of encryption before transmitting the control commands to the remote control 320”, or could simply act as a router for relaying the control commands from the patients’ display device 334 to the remote control 320” . It is also conceivable that the DDI 330 adds a layer of end-to-end encryption directed at the implanted system 10, such that only the implanted system 10 can decrypt the control commands to perform the commands intended by the patient. In the embodiments above, when the patient remote display device 334 is communicating with the DDI, the patient’s display device 334 may be configured to only display and interact with a web-view portal provided by a section of the DDI. It is conceivable that the web-view portal is a view of a back-end provided on the DDI 330, and that in such embodiments the patient interacting with the control interface on the patient’s display device 334 is equivalent to the patient interacting with an area of the DDI 330.
The patient’s display device 334 could have a first and second application related to the implanted system 10. The first application is the control application displaying the control interface 334i for control of the implanted system 10, whereas the second application is a general application for providing the patient with general information of the status of the implanted system 10 or information from the DDI 330 or HCP, or for providing an interface for the patient to provide general input to the DDI 330 or HCP related to the general wellbeing of the patient, the lifestyle of the patient or related to general input from the patient concerning the function of the implanted system 10. The second application, which do not provide input to the remote control 320” and/or the implanted system 10 thus handles data which is less sensitive. As such, the general application could be configured to function also when all auxiliary radio connections are activated, whereas switching to the control application which handles the more sensitive control commands and communication with the implanted system 10 could require that the auxiliary radio connections are temporarily de-activated. It is also conceivable that the control application is a sub-application running within the general application, in which case the activation of the control application as a sub-application in the general application could require the temporary de-activation of auxiliary radio connections. In the embodiment shown in fig. 57f, access to the control application requires the use of the optical and/or NFC means of the hardware key 333’ in combination with biometric input to the patient’s display device, whereas accessing the general application only requires biometric input to the patient’s display device and/or a pin code. In an example, a two-factor authentication solution, such as a digital key in combination with a pin code could be used for accessing the general application and/or the control application.
In general, a hardware key may be needed to activate the patient display device 334 for certain time period to control the web-view portal of the remote control 320”, displaying the control interface 334i for control of the implanted system 10.
In the embodiments in which the patients display device 334 is configured to only display and interact with a web-view provided by another unit in the system, it is conceivable that the webview portal is a view of a back-end provided on the DDI 330, and in such embodiments, the patient interacting with the control interface on the patient’s display device is equivalent to the patient interacting with an area of the DDI 330.
Moving now to the P-EID 320’”. The P-EID 320’” is an external device used by the patient, patient external device, configured to communicate with, and charge, the implanted system 10. The P-EID 320’” can be remotely controlled by the HCP to read information from the implanted system 10. The P-EID 320’” is adapted to control the operation of the implanted system 10, control the charging of the implantable system 10, and adjust the settings on the controller 300 of the implanted system 10 by changing pre-defined pre-programmed steps and/or by the selection of pre-defined parameters within a defined range.
Similar to the remote control 320”, the P-EID 320” ’ may be configured to communicate with the implanted system 10 using BT or UWB communication or any other proprietary or standard communication method. Since the device may be used for charging the implant, the charging signal and communication could be combined. Similar to the remote control 320”, it is also possible to use a combination of UWB wireless communication and BT for enabling positioning of the P-EID 320” as a way to establish that the P-EID 320” is at a position which the implanted system 10 and/or patient and/or HCP can acknowledge as being correct, e.g. in the direct proximity to the correct patient and/or the correct system 10. Just as for the remote control 320”, in embodiments in which a combination of BT and UWB technology is used, the UWB technology may be used for location-based authentication of the P-EID 320”, whereas the communication and/or data transfer could take place using BT. The P-EID 320” comprises a wireless transmitter/transceiver 328 for communication and also comprises a wireless transmitter 325 configured for transferring energy wirelessly, which may be in the form of a magnetic field or any other signal such as electromagnetic, radio, light, sound or any other type of signal to transfer energy wirelessly to a wireless receiver 395 of the implanted system 10. The wireless receiver 395 of the implanted system 10 is configured to receive the energy in the form of the magnetic field and transform the energy into electric energy for storage in an implanted energy storage unit 40, and/or for consumption in an energy consuming part of the implanted system 10 (such as the operation device, controller 300 etc.). The magnetic field generated in the P-EID 320’” and received in the implanted system 10 is denoted charging signal. In addition to enabling the wireless transfer of energy from the P-EID 320”’ to the implanted system 10, the charging signal may also function as a means of communication. E.g., variations in the frequency of the transmission, and/or the amplitude of the signal may be uses as signaling means for enabling communication in one direction, from the P-EID 320’” to the implanted system 10, or in both directions between the P- EID 320’” and the implanted system 10. The charging signal in the embodiment shown in fig. 57F is a signal in the range 10 - 65kHz or 115 - 140 kHz and the communication follow a proprietary communication signaling protocol, i.e., it is not based on an open standard. In alternative embodiments, BT could be combined with communication using the charging signal, or communication using the charging signal could be combined with an UWB signal. The energy signal could also be used as a carrying signal for the communication signal.
Just as for the remote control 320”, the UWB signal could in some embodiments also be used as a wake-up signal for the controller 300, or for the BT transceiver, such that the BT transceiver in the implanted system 10 can be turned off when not in use, which eliminates the risk that the BT is intercepted, or that the controller 300 of the implanted system 10 is hacked by means of BT communication. In some examples, the charging signal could be used as a wakeup signal for the BT, as the charging signal does not necessarily travel very far. Also, as a means of locationbased authentication, the effect of the charging signal or the RSSI could be assessed by the controller 300 in the implanted system 10 to establish that the transmitter is within a defined range. In the BT/UWB combination, the UWB may be used also for transmission of data. In some embodiments, the UWB and/or the charging signal could be used for the transmission of some portions of the data, such as sensitive portions of the data, or for the transmission keys for unlocking encrypted communication sent by BT. Wake-up could be performed with any other signal.
UWB could also be used for waking up the charging signal transmission, to start the wireless transfer of energy or for initiating communication using the charging signal. As the signal for transferring energy has a very high effect in relation to normal radio communication signals, the signal for transferring energy cannot be active all the time, as this signal may be hazardous e.g., by generating heat.
The P-EID 320’” may communicate with the HCP over the Internet by means of a secure communication, such as over a VPN. The communication between the HCP and the P-EID 320’” is preferably encrypted. Preferably, the communication is sent via the DDI, which may only be relaying the information. The communication from the HCP to the implanted system 10 may be performed using an end-to-end encryption, in which case the communication cannot be decrypted by the P-EID 320’”. In such embodiments, the P-EID 320’” acts as a router, only passing on encrypted communication from the HCP to the controller 300 of the implanted system 10 (without full decryption). This solution further increases security as the keys for decrypting the information rests only with the HCP and with the implanted system 10, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device. The P-EID 320”’ may add own encryption or information, specifically for security reasons. The P-EID 320’” may hold its own private key and may be allowed to communicate with the implant 100 based on confirmation from the patient’s private key, which may be provided as a smartcard to be inserted in a slot of the P-EID 320’” or hold in close proximity thereto to be read by the P-EID 320’”. These two keys will add a high level of security to the performed communication between the implanted system 10 and the P- EID 320’” since the patient’s hardware key in this example on the smartcard may activate and thereby allow the communication and action taken in relation to the system 10. The P-EID 320’” may as previously described change the treatment setting of the system 10 by selecting preprogrammed steps of the treatment possibilities. Such pre-programmed treatment options may include for example to change: at least one of the level of pressure or a distance of a hydraulic, mechanic, and/or electric adjustable vessel member, a volume in a hydraulic adjustable vessel member or a reservoir connected to the hydraulic adjustable vessel member, parameters of an implant monitoring an aneurysm, such as pressure, aneurysm expansion, volume, reservoir volume, etc., parameters of an implant for hindering the expansion of an aneurysm, such as pressure, aneurysm expansion, volume, reservoir volume, etc., parameters of an implantable system communicating with a database outside the body, such as key handshake, new key pairing, signal amplitude etc., parameters of an implant able to be programmed from outside the body, parameters of an implant able to be programmed from outside the body with a wireless signal,
When the implanted medical device 100 is to be controlled and/or updated remotely by the HCP, via the P-EID 320’”, a HCP Dedicated Device (DD) 332 displays an interface in which predefined program steps or setting values are presented to the HCP. The HCP provides input to the HCP DD 332 by selecting program steps, altering settings and/or values or by altering the order in which pre-defined program steps is to be executed. The instructions/parameters inputted into the HCP DD 332 for remote operation is in the embodiment shown in fig. 57F routed to the P-EID 320’” via the DDI 330, which may or may not be able to decrypt/read the instructions. The DDI 330 may store the instructions for a time period to later transfer the instructions in a package of created instructions to the P-EID 320’”. It is also conceivable that an additional layer of encryption is provided to the package by the DDI 330. The additional layer of encryption may be a layer of encryption to be decrypted by the P-EID 330, or a layer of encryption which may only be decrypted by the controller 300 of the implanted system 10, which reduces the risk that unencrypted instructions or packages are intercepted by unauthorized devices. The instructions/parameters are then provided to the P-EID 320”, which then loads the instructions/parameters into the during the next charging/energy transfer to the implanted system 10 using any of the signal transferring means (wireless or conductive) disclosed herein.
The Health Care Provider EID (HCP EID) 320’ have the same features as the P- EID 320” and can communicate with the implanted system 10 in the same alternative ways (and combinations of alternative ways) as the P-EID 320”’. However, in addition, the HCP EID 320’ also enables the HCP to freely reprogram the controller 300 of the implanted system 10, including replacing the entire program code running in the controller 300. The idea is that the HCP EID 320’ always remain with the HCP and as such, all updates to the program code or retrieval of data from the implanted system 10 using the HCP EID 320’ is performed with the HCP and patient present (i.e. not remote). The physical presence of the HCP is an additional layer of security for these updates which may be critical to the function of the implanted system 10.
In the embodiment shown in fig. 57F, the HCP communicates with the HCP EID 320’ using a HCP Dedicated Display Device 332 (HCP DDD), which is a HCP display device comprising a control interface for controlling and communicating with the HCP EID 320’. As the HCP EID 320’ always stays physically at the HCP’s clinic, communication between the HCP EID 320’ and HCP DDD 332 does not have to be sent over the Internet. Instead, the HCP DDD 332 and the HCP EID 320’ can communicate using one or more of BT, a proprietary wireless communication channel, or a wired connection. The alteration to the programming is then sent to the implanted system 10 directly via the HCP EID 320’. Inputting into the HCP DDD 332 for direct operation by means of the HCP EID 320’ is the same as inputting directly into the HCP EID 320’, which then directly transfers the instructions into the implanted system 10.
In the embodiment shown in fig. 57F, both the patient and the HCP has a combined hardware key 333’, 333”. The combined keys 333’, 333” comprises a hardware component comprising a unique circuitry (providing the highest level of security), a wireless NFC-transmitter 339 for transmitting a specific code (providing mid-level security), and a printed QR-code 344 for optical recognition of the card (providing the lowest level of security). The HCP private key is supplied by a HCP private key device 333” adapted to be provided to the HCP EID external device via at least one of; a reading slot or comparable for the HCP private key device 333”, an RFID communication or other close distance wireless activation communication to both the HCP EID 320’ and the HCP DDD 332 if used. The HCP DDD 332 will be activated by such HCP private key device 333”, which for example may comprise at least one of, a smartcard, a key-ring device, a watch an arm or wrist band a neckless or any shape device.
The HCP EID external device may comprise at least one of; a reading slot or comparable for the HCP private key device, an RFID communication and other close distance wireless activation communication means
The HCP external device 320’ may further comprise at least one wireless transceiver 328 configured for communication with a data infrastructure server, DDI, through a first network protocol.
A dedicated data infrastructure server, DDI, is in one embodiment adapted to receive commands from said HCP external device 320’ and may be adapted to rely the received commands without opening said commands directed to the patient external device 320”, the DDI 330 comprising one wireless transceiver configured for communication with said patient external device 320”.
The patient EID external device 320” is in one embodiment adapted to receive the commands relayed by the DDI, and further adapted to send these commands to the implanted medical device 100, which is adapted to receive commands from the HCP, Health Care Provider, via the DDI 330 to change the pre-programmed treatment steps of the implanted system 10. The patient EID is adapted to be activated and authenticated and allowed to perform the commands by the patient providing a patient private key device 333’. The patient’s private key device is in one embodiment adapted to be provided to the patient external device by the patient via at least one of; a reading slot or comparable for the patient private key device 333’, an RFID communication or other close distance wireless activation communication.
The patient EID external device, in one or more embodiments, comprises at least one of; a reading slot or comparable for the HCP private key device, an RFID communication, or other close distance wireless activation communication
The patient EID external device may in one or more embodiments comprise at least one wireless transceiver configured for communication with the implanted system 10 through a second network protocol.
The patient’s key 333’ is in the embodiment shown in fig. 66A in the form of a key card having an interface for communicating with the P-EID 320’”, such that the key card could be inserted into a key card slot in the P-EID 320”. The NFC-transmitter 339 and/or the printed QR- code 344 can be used as means for accessing the control interface 334i of the display device 334. In addition, the display device 334 may require a pin-code and/or a biometric input, such as face recognition or fingerprint recognition.
The HCP’s key 333”, in the embodiment shown in fig. 57F is in the form of a key card having an interface for communicating with the HCP -EID 320’, such that in one embodiment the key card could be inserted into a key card slot in the HCP -EID 320’. The NFC-transmitter 339 and/or the printed QR-code 344 can be used as means for accessing the control interface of the HCP DDD 332. In addition, the HCP DDD 332 may require a pin-code and/or a biometric input, such as face recognition or fingerprint recognition. In alternative embodiments, it is however conceivable that the hardware key solution is replaced by a two-factor authentication solution, such as a digital key in combination with a PIN code or a biometric input (such as face recognition and/or fingerprint recognition). The key could also be a software key, holding similar advance key features, such as the Swedish Bank ID being a good example thereof.
In the embodiment shown in fig. 57F, communication over the Internet takes place over a Dedicated Data Infrastructure (DDI) 330, running on a cloud service. The DDI 330 in this case handles communication between the HCP DDD 332 and the P-EID 320”’. however, the more likely scenario is that the HCP DDD 332 is closed down, such that only the necessary functions of the control application can function on the HCP DDD 332. In the closed down embodiment, the HCP DDD 332 is only able to give the necessary commands to HCP EID 320’ to further update the pre-programmed treatment steps of the Implant 100 via the P-EID 320’” in direct contact, or more likely indirect contact via the DDI 332. If the patient is present locally, the HCP EID may communicate and act directly on the patient’s implant. However, before anything is accepted by the implant, a patient private key device 333’ has to be presented to the P EID 320”’ or HCP EID 320’ for maximum security.
The DDI 330 is logging information of the contact between the HCP and the remote control 320” via implant feedback data supplied from the implant to P-EID 320” ’ . Data generated between the HCP and the patient’s display device 334, as well as between the HCP and auxiliary devices 336 (such as tools for following up the patient’s treatments e.g. a blood pressure monitor) are logged by the DDI 330. In some embodiments, although less likely, the HCP DDD 332 may also handle the communication between the patient’s display device 334 and the remote control 320”. In fig. 57F, auxiliary devices 336 are connected to the P-EID as well and can thus provide input from the auxiliary devices 336 to the P-EID which can be used by the P-EID for altering the treatment or for follow up.
In all examples, the communication from the HCP to: the P-EID 320’”, the remote control 320”, the patient’s display device 334 and the auxiliary devices 336 may be performed using an end-to-end encryption. In embodiments with end-to-end encryption, the communication cannot be decrypted by the DDI 330. In such embodiments, the DDI 330 acts as a router, only passing on encrypted communication from the HCP to various devices. This solution further increases security as the keys for decrypting the information rests only with the HCP and with the device sending or receiving the communication, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device. The P-EID 320’” may also only pass on encrypted information.
In addition to acting as an intermediary or router for communication, the DDI 330 collects data on the implanted medical device 100, relating to the treatment and to the patient. The data may be collected in an encrypted form, in an anonymized form or in an open form. The form of the collected data may depend on the sensitivity of the data or on the source from which the data is collected. In the embodiment shown in fig. 66A, the DDI 330 sends a questionnaire to the patient’s display device 334. The questionnaire could comprise questions to the patient related to the general health of the patient, related to the way of life of the patient, or related specifically to the treatment provided by the implanted system 10 (such as for example a visual analogue scale for measuring pain). The DDI 330 could compile and/or combine input from several sources and communicate the input to the HCP which could use the provided information to create instructions to the various devices to be sent back over the DDI 330. The data collection performed by the DDI 330 could also be in the form a log to make sure that all communication between the units in the system can be back traced. Logging the communication ensures that all alterations to software or the settings of the software, as well as the frequency and operation of the implanted system 10 can be followed. Following the communication enables the DDI 330 or the HCP to follow the treatment and react it something in the communication indicates that the treatment does not provide the intended results or if something appears to be wrong with any of the components in the system. If patient feedback from the patient display device 334 indicates that a new treatment step of the implant is needed, such information must be confirmed by direct contact between HCP and patient.
In the specific embodiment disclosed in fig. 57F, the wireless connections between the different units are as follows. The wireless connection 411 between the auxiliary device 336 and the DDI 330 is based on WiFi or a mobile telecommunication regime or may be sent to the DDI 330 via the P-EID 320’” and the wireless connection 411 between the auxiliary device 336 and the patient’s display device 334 is based on BT or any other communication pathway disclosed herein. The wireless connection 412 between the patient’s display device 334 and the DDI 330 is based on WiFi or a mobile telecommunication regime. The wireless connection 413 between the patient’s display device 334 and the remote control 320” is based on BT or any other communication pathway disclosed herein. The wireless connection 414 between the patient remote control 320” and the implanted system 10 is based on BT and UWB or any other communication pathway disclosed herein. The wireless connection 415 between the remote control 320” and the DDI 330 is likely to not be used, and if present be based on WiFi or a mobile telecommunication regime. The wireless connection 416 between the P-EID 320’” and the implanted system 10 is based on BT, UWB and the charging signal or any other communication or energizing pathway disclosed herein. The wireless connection 417 between the P-EID 320’” and the DDI 330 is based on WiFi or a mobile telecommunication regime. The wireless connection 418 between the HCP-EID 320’ and the implanted system 10 is based on at least one of the BT, UWB and the charging signal. The wireless connection 419 between the P-EID 320’” and the HCP DD 332 is based on BT or any other communication path disclosed herein. The wireless connection 420 between the HPC-EID 320’ and the DDI 330 is based on WiFi or a mobile telecommunication regime. The wireless connection 421 between the HPC DD 332 and the DDI 330 is normally closed and not used and if so based on WiFi or a mobile telecommunication regime. The wireless connection 422 between the HCP-EID 320’ and the HCP DD 332 is based on at least one of BT, UWB, local network or any other communication path disclosed herein.
The wireless connections specifically described in the embodiment shown in fig. 57F may however be replaced or assisted by wireless connections based on radio frequency identification (RFID), near field communication (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The mobile telecommunication regimes may for example be 1G, 2G, 3G, 4G, or 5G. The wireless connections may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), or quadrature amplitude modulation (QAM). The wireless connection may further feature technologies such as time-division multiple access (TDMA), frequency-division multiple access (FDMA), or codedivision multiple access (CDMA). The wireless connection may also be based on infra-red (IR) communication. The wireless connection may feature radio frequencies in the high frequency band (HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF) as well as essentially any other applicable band for electromagnetic wave communication. The wireless connection may also be based on ultrasound communication to name at least one example that does not rely on electromagnetic waves.
Fig. 57G also discloses a master private key 333’” device that allow issuance of new private key device wherein the HCP or HCP admin have such master private key 333’” device adapted to be able to replace and pair a new patient private key 333’ device or HCP private key device 333” into the system, through the HCP EID external device 320’.
A system configured for changing pre-programmed treatment settings of an implantable system 10, when implanted in a patient, from a distant remote location in relation to the patient, will be discussed in the following.
Fig. 57G discloses a scenario in which at least one health care provider, HCP, external device 320’ is adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted system 10, further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333”. The HCP EID external device 320’ further comprising at least one wireless transceiver 328 configured for communication with a patient EID external device 320”’, through a first network protocol. The system comprises the patient EID external device 320’”, the patient EID external 320’” device being adapted to receive command from said HCP external device 320’, and to relay the received command without modifying said command to the implanted system 10. The patient EID external device 320’” comprises a wireless transceiver 328. The patient EID 320’” is adapted to send the command to the implanted system 10, to receive a command from the HCP to change said preprogrammed treatment settings of the implanted system 10, and further to be activated and authenticated and allowed to perform said command by the patient providing a patient private key 333’ device comprising a patient private key. Although wireless transfer is primarily described in the embodiment disclosed with reference to figs. 57G the wireless communication between any of the external device may be substituted for wired communication. Also, some or all of the wireless communication between an external device and the implanted system 10 may be substituted for conductive communication using a portion of the human body as conductor.
Fig. 57H shows a portion of fig. 57F, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 57H, the system is configured for changing pre-programmed treatment settings of an implantable system 10, when implanted in a patient, from a distant remote location in relation to the patient. The system of fig. 57H comprises at least one HCP EID 320’ external device adapted to receive commands from the HCP to change said pre-programmed treatment settings of an implanted system 10. The HCP EID 320’ external device is further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333” adapted to be provided to the HCP EID external device 320’. The private key device 333” is adapted to be provided to the HCP EID external device 320’ via at least one of: a reading slot or comparable for the HCP private key device 333”, and an RFID communication or other close distance wireless activation communication.
The HCP EID external device 320’ comprises at least one of: a reading slot or comparable for the HCP private key device 333”, an RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device 320’ further comprises at least one wireless transceiver 328 configured for communication with a dedicated data infrastructure server (DDI) 330, through a first network protocol. The system further comprises a dedicated data infrastructure server (DDI) 330, adapted to receive command from said HCP EID external device 320’, adapted to relay the received commands without modifying said command to a patient EID external device 320’”. The dedicated data infrastructure server (DDI) 330 further comprises a wireless transceiver 328 configured for communication with said patient external device. The system further comprises a patient EID external device 320”’ adapted to receive the command relayed by the dedicated data infrastructure server (DDI) 330 and further adapted to send commands to the implanted system 10 and further adapted to receive commands from the HCP EID external device 320’ via the dedicated data infrastructure server (DDI) 330 to change said preprogrammed treatment settings of the implanted system 10. The patient EID external device 320’” may further be adapted to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device 333’, which may be adapted to be provided to the patient EID external device 320’” by the patient via at least one of: a reading slot or comparable for the patient private key device 333’, an RFID communication or other close distance wireless activation communication or electrical direct contact. The patient EID external device 320’” further comprises at least one of: a reading slot or comparable for the HCP private key device, an RFID communication and other close distance wireless activation communication or electrical direct contact. The patient EID external device 320”’ further comprises at least one wireless transceiver 328 configured for communication with the implanted system 10 through a second network protocol. The implanted system 10 is in turn configured to treat the patient or perform a bodily function.
The scenario described with reference to fig. 57H may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 571 - 57K.
Fig. 571 shows a portion of fig. 57F, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 571, a system configured for changing pre-programmed treatment settings of an implantable system 10 is disclosed. The changing of the pre-programmed treatment settings is performed by a health care provider (HCP) in the physical presence of the patient. The system comprises at least one HCP EID external device 320’ adapted to receive commands from the HCP, directly or indirectly, to change said pre-programmed treatment settings in steps of an implantable system 10, when implanted. The HCP EID external device 320’ is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing a HCP private key device 333 ” comprising a HCP private key. The HCP private key device in the embodiment of fig. 571 comprises at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device. The HCP EID external device 320’ is adapted to be involved in at least one of: receiving information from the implant 100, receiving information from a patient remote external device 336, actuating the implanted system 10, changing pre-programmed settings, and updating software of the implantable system 10, when implanted. The HCP EID external device 320’ is adapted to be activated, authenticated, and allowed to perform said command also by the patient, the system comprises a patient private key device 333’ comprising a patient private key. The patient private key device 333’ may comprise at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device. The HCP private key 333” and the patient’s private key may be required for performing said actions by the HCP EID external device 320’ to at least one of: receive information from the implant 100, to receive information from a patient remote external device 336, to actuate the implanted system 10, to change pre-programmed settings, and to update software of the implantable system 10, when the implantable system 10 is implanted.
Fig. 571 also outlines a scenario in which the system is configured for changing preprogrammed treatment settings in steps of an implantable medical device, when implanted in a patient, by a health care provider, HCP, wherein the patient may be located at a remote location, or on a distance. The system may comprise: at least one HCP EID external device 320’ adapted to receive a command from the HCP, directly or indirectly, to change said pre-programmed treatment settings in steps of an implanted medical device The HCP EID external device 320’ is further adapted to be activated, authenticated, and allowed to perform said command by the HCP. The action by the HCP EID external device 320’ to change pre-programmed settings in the implant 100 and to update software of the implantable medical device 100, when the implantable medical device 100 is implanted, is adapted to be authenticated by a HCP private key device 333” and a patient private key device 333’.
The scenario described with reference to fig. 571 may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 57H, or 57J - 57K.
Fig. 57J shows a portion of fig. 57F, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 57 J, a system configured to change pre-programmed and pre-selected treatment actions of an implantable system 10 by a command from the patient is described. The system comprises an implantable system 10, a patient remote external device 320”, and a wireless transceiver 328 configured for communication with the implantable system 10, when the system 10 is implanted, through a second network protocol. The system further comprises a remote display portal interface 334i configured to receive content delivered from the patient remote external device 320” to expose buttons to express the will to actuate the functions of the implanted system 10 by the patient through the patient remote external device 320” . The remote external device 320” is further configured to present the display portal remotely on a patient display device 334 allowing the patient to actuate the functions of the implanted system 10 through the display portal of the patient remote external device 320” visualised on the patient display device 334. In fig. 57J, a further wireless connection 423 between the patient remote external device 320” and the patient EID external device 320’” is provided. This further wireless connection 423 could be a wireless connection according to any one of the wireless signaling methods and protocols described herein, and the communication can be encrypted.
The scenario described with reference to fig. 57J may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 57H, 571, or 57K.
Fig. 57K shows a portion of fig. 57F, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 57K, a system configured for providing information from an implantable medical system 10, when implanted in a patient, from a distant remote location in relation to the patient is described. The system comprises at least one patient EID external device 320’” adapted to receive information from the implant 100, and to send such information further on to a server or dedicated data infrastructure, DDI, 330. The patient EID external device 320’” is further adapted to be activated and authenticated and allowed to receive said information from the implanted system 10 by the patient providing a private key. The patient private key device comprises the private key adapted to be provided to the patient EID external device 320”’ via at least one of: a reading slot or comparable for the patient private key device, an RFID communication or other close distance wireless activation communication or direct electrical connection, The patient EID external device 320’” comprises at least one of: a reading slot or comparable for the patient private key device, an RFID communication and other close distance wireless activation communication or direct electrical contact. The patient EID external device 320’” further comprises at least one wireless transceiver 328 configured for communication with the DDI 330, through a first network protocol.
The scenario described with reference to fig. 57K may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 57H - 57J.
Fig. 57L shows a portion of fig. 57F, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 57L a system configured for changing pre-programmed treatment settings in steps of an implantable system 10, when implanted in a patient, by a health care provider, HCP, either in the physical presence of the patient or remotely with the patient on distance is described. The system comprises at least one HCP EID external device 320’ adapted to receive a command directly or indirectly from the HCP to change said preprogrammed treatment settings in steps of the implantable system 10, when implanted, wherein the HCP EID external device 320’ is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing a HCP private key device comprising a HCP private key. The HCP private key comprises at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device. The system further comprises a patient private key device comprising a patient private key comprising at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device. Both the HCP and patient private key is required for performing said action by the HCP EID external device 320’ to change the pre-programmed settings in the system 10 and to update software of the implantable system 10, when the implantable system 10 is implanted. The patient private key is adapted to activate, be authenticated, and allowed to perform said command provided by the HCP, either via the HCP EID external device or when the action is performed remotely via a patient EID external device 320’. In the embodiment shown in fig. 57L, the communication is routed over the DDI server 330.
The scenario described with reference to fig. 57L may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 57H - 57K.
Fig. 57M shows an overview of an embodiment of the system, similar to the one described with reference to fig. 57F, the difference being that the HCP EID and the HCP DDD are combined into a single device. Fig. 57N shows an overview of an embodiment of the system, similar to that described with reference to fig. 57F, the difference being that the HCP EID external device 320”’ and the HCP DDD 332 are combined into a single device and the P-EID external device 320’” and the patient remote control external device 320” are combined into a single device.
One probable scenario / design of the communication system is for the purpose of changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient. The system comprises at least one health care provider, HCP, external device 320’ adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted system 10. The HCP external device 320 ‘ is further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333”, which may be adapted to be provided to an HCP EID external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication or other close distance wireless activation communication. The HCP EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device further comprises at least one wireless transceiver configured for communication with a patient EID external device, through a first network protocol, wherein the system comprises the patient EID external device, the patient EID external device being adapted to receive command from said HCP external device, and to relay the received command without modifying said command to the implanted medical device. The patient EID external device comprising one wireless transceiver configured for communication with said patient external device. The patient EID is adapted to send the command to the implanted medical device, to receive a command from the HCP to change said pre-programmed treatment settings of the implanted medical device, and further to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device comprising a patient private key.
Although the different scenarios outlined in figures 57H - 57N are described with specific units and method of signaling, these scenarios may very well be combined with each other or complemented with additional units or communication connections. The embodiments described herein may advantageously be combined.
A computer program product of, or adapted to be run on, an internal computing unit or an external device is also provided, which comprises a computer-readable storage medium with instructions adapted to make the internal computing unit and/or the external device perform the actions as described in any embodiment or example above. [0001] Although the different scenarios outlined in figures 57F - 57N are described with specific units and method of signaling, these scenarios may very well be combined with each other or complemented with additional units or communication connections. [0002] As have been discussed before in this application, communication with a medical implant needs to be reliable and secure. For this purpose, it is desirable to have a standalone device as an external remote control (for example described as 320” in figs 57F - 57N) for the medical implant, such that no other programs or applications run on the same device which may disturb or corrupt the communication to the medical implant. However, the smartphone or tablet (for example described as 334 in figs 57F - 57N) has become an integrated part of everyday life for most people. This means that we almost always have our smartphones at hand. For this reason, it would have been convenient for the patient to communicate with the medical implant directly using the smartphone, such that no additional standalone device would have to be carried. However, as a lot of other applications are running on the smartphone, it does not fulfill the requirement of being a secure and reliable communication tool without interference from other communication. It is therefore desirable to split the tasks of providing secure communication between the external device and the implant from the task of communicating with the Internet and providing a familiar and intuitive user interface. For this purpose, and external device providing secure communication and tamperproof soft- and hardware, where the display device allows for intuitive and easy use is provided. In the embodiments described with reference to figs. 570 - 57S a device fulfilling these combinatory needs will be described in the form of a standalone remote control external device integrated in a housing unit 320” connectable to a smartphone or another display device 334, such as a smart watch or a tablet.
[0003] Figs. 57g shows the housing unit 320” in an elevated perspective view form the left, and fig. 57h shows the housing unit 320” in a plain view from the left. In the embodiment shown in fig. 57g, the housing unit 320” has a rectangular shape with rounded edges, having a height 1521 which is more than 1,5 times the width 1522. The housing unit 320” comprises recess 1525 configured to receive a display device 334, in the form of a smartphone, configured to be fitted in the housing unit 320” for mechanically, disconnectably connecting the display device 334 to the housing unit 320”. The boundaries of the recess 1525 in the housing unit 320” forms an edge 1528 configured to encircle the display device 334, when the display device 334 is inserted into the recess 1525. In the embodiment shown in fig. 57g, the recess 1525 has a depth 1526 configured to allow the display device 334 to be entirely inserted into the recess 1525. As such, the depth 1526 of the recess 1525 exceeds the depth 1531 of the display device 334. In the embodiment shown in figs. 57g and 57h, the edge is relatively thin, and has a width 1527 which is in the range 1/8 - 1/100 of the width of the display device 334, as such, the housing unit 320” has a width in the range 1,02 - 1,25 times the width 1522 of the housing unit 320”. In the same way, the housing unit 320” has a height 1521 in the range 1,01 - 1,25 times the height 1521 of the display device 334. In the embodiment shown in figs.57g - 57h, the edges 1528 are configured to clasp the display device 334 and thereby mechanically fixate the display device 334 in the housing unit 320”. The minimum bounding box of the housing unit 320” and the display device 334 when mechanically connected, is no more than, 10 % wider, 10 % longer or 100 % higher, than the minimum bounding box of the display device 334.
[0004] For creating a clasping fixation, the edges of the housing unit 320” is made from an elastic material crating a tension between the edge 1528 and the display device 334 holding the display device 334 in place. The elastic material could be an elastic polymer material, or a thin sheet of elastic metal. For the purpose of further fixating the display device 334 in the housing unit 320”, the inner surface of the edges 1528 may optionally comprise a recess or protrusion (not shown) corresponding to a recess or protrusion of the outer surface of the display device 334. The edges 1528 may in the alterative comprise concave portions for creating a snap-lock clasping mechanical fixation between the housing unit 320” and the display device 334.
[0005] In the embodiment shown in figs. 57g and 57h, the housing unit 320” functions as a remote control for communicating with an implanted medical device, including receiving information from, and providing instructions and updates to, the implanted medical device. Information could be information related to a state of the implanted medical device including any functional parameter of the implanted medical device or could be related to a state of the patient, including any physiological parameter pertaining to the body of the patient (further described on other sections of this disclosure). For the purpose of providing input to the implanted medical device and controlling and updating the functions of the housing unit 320”, the housing unit 320” comprises a control interface comprising switches in the form of control buttons 335. The control buttons 335 are configured to be used when the external device is disconnected from the display device 334. The control interface further comprises a display 1505, which is a smaller and typically less sophisticated display 1505 than the display of the display device 334. In an alternative embodiment, the control buttons 335 and display 1505 are integrated into a single touch-responsive (touchscreen) display on which the control buttons may be displayed. In the embodiment shown in figs. 57g and 57h, one of the control buttons 335 is a control button for activating the implanted medical device and another of the control buttons 335 is a control button for deactivating the implanted medical device. When the display device 334 is attached to the housing unit 320”, the control buttons 335 and the display is covered by the display device 334 and are as such not in an operational state. In the embodiment shown in figs 57g and 57h, the housing unit 320” is configured to transmit information pertaining to the display of the user interface to the display device 334 and the display device 334 is configured to receive input pertaining to communication to or from the implantable medical device from the patient, and transmit signals based on the received input to the housing unit 320” . The input may be a command to change the operational state of the implantable medical device. The display device 334 comprises a touch screen configured to display the user interface and receive the input from the patient. The display of the display device 334 may comprise one or more OLEDs or IPS LCDs elements. When the display device 334 is connected to the housing unit 320”, the display device 334 is configured to display a control interface which is used to communicate with the housing unit 320”, i.e. providing input to and receiving information from the housing unit 320”. The input provided the housing unit 320” is then relayed to the implanted medical device - and in the same way information communicated from the implanted medical device to the housing unit 320” may be relayed or displayed on the display device 334. Having an external device comprising a combination of a housing unit 320” comprising the communication means for communicating with the implanted medical device and a display device 334 basically only functioning as and Input/Output device connected to the housing unit 320” makes it possible to have a secure communication between the housing unit 320” and the display device 334, which is out of reach from the Internet connection of the display device 334, which makes it much harder for an external attacker to get access to any of the vital communication portions of the housing unit 320”. The communication between the housing unit and the display device 334 is very restricted and the only communication allowed from the display device 334 to the housing unit 320” is input from the patient or a healthcare professional, and authentication parameters created by an authentication application running on the display device 334. The authentication application running on the display device 334 could be a numbergenerating authenticator or a biometric authenticator for authenticating the patient or health care professional, and the authentication parameters could for example be parameters derived from a facial image or a fingerprint. In the opposite direction, i.e. from the housing unit 320” to the display device 334, the communication could be restricted to only communication needed for displaying information and/or a graphical user interface on the display device 334. The communication restrictions could for example be based on size of the communication packages or the frequency with which the communication takes place which reduces the risk that an unauthorized person makes multiple attempts to extract information from, or transit information to, the hand-held device.
[0006] In the embodiment shown with reference to figs. 57g and 57h, the housing unit 320” comprises a first communication unit providing a wireless connection 413 to the display device 334. The wireless connection 413 is in the embodiment shown in figs- 57g and 57h based on NFC, but could in alternative embodiment be based on Bluetooth or any other communication pathway disclosed herein. The housing unit 320” further comprises a second communication unit providing a wireless connection with the implanted medical device. The wireless communication between the housing unit 320” and the implanted medical device is in the embodiment shown in figs. 57g and 57h based on Bluetooth, but could in alternative embodiments be based on NFC or UWB or any other communication pathway disclosed herein.
[0007] As mentioned, in the embodiment shown in figs. 57g and 57h, the wireless communication between the housing unit 320” and the display device 334 is based on NFC, while the wireless communication between the housing unit 320” and the is based on Bluetooth. As such, the first communication unit of the housing unit 320” is configured to communicate wirelessly with the display device 334’ using a first communication frequency and the second communication unit of the housing unit 320” is configured to communicate wirelessly with the implantable medical device using a second different communication frequency. For this purpose, the first communication unit of the housing unit 320” comprises a first antenna configured for NFC-based wireless communication with the display device 334, and the second communication unit comprises a second antenna configured for Bluetooth-based wireless communication with the implantable medical device. The first and second antennae may be a wire-based antennae or a substrate-based antennae. As such, the first communication unit is configured to communicate wirelessly with the display device 334 on a first frequency and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second different communication frequency. Also, first communication unit of the housing unit 320’ is configured to communicate wirelessly with the display device 334 using a first communication protocol (the NFC-communication protocol), and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication protocol (the Bluetooth communication protocol). The first and second communication protocols are different which adds an additional layer of security as security structures could be built into the electronics and/or software enabling the transfer from a first to a second communication protocol.
[0008] In an alternative embodiment, the second communication unit may be configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 100 kHz, or preferably at a frequency below 40 kHz. The second communication unit may thus be configured to communicate with the implantable medical device using “Very Low Frequency” communication (VLF). VLF signals have the ability to penetrate a titanium housing of the implant, such that the electronics of the implantable medical device can be completely encapsulated in a titanium housing. In yet further embodiments, the first and second communication units may be configured to communicate by means of an RFID type protocol, a WLAN type protocol, a BLE type protocol, a 3G/4G/5G type protocol, or a GSM type protocol. [0009] In yet other alternative embodiments, it is conceivable that the mechanical connection between the housing unit 320” and the display device 334 comprises an electrical connection for creating a wire-based communication channel between the housing unit 320” and the display device 334. The electrical connection could also be configured to transfer electric energy from the display device 334 to the housing unit, such that the housing unit 320” may be powered or charged by the display device 334. A wired connection is even harder to access for a non-authorized entity than an NFC-based wireless connection, which further increases the security of the communication between the housing unit 320” and the display device 334.
[00010] In the embodiment shown with reference to figs. 57g and 57h, the display device 334 comprises a first communication unit providing a wireless connection 413 to the housing unit 320” based on NFC. The display device 334 further comprises a second communication unit providing a wireless connection with a further external device and/or with the Internet. The second external device may be far away, for example at a hospital or a place where a medical professional practice. The wireless communication between the display device 334 and a further external device is in the embodiment shown in figs. 57g and 57h based on WiFi, but could in alternative embodiments be based on for example Bluetooth.
[00011] As mentioned, in the embodiment shown in figs. 57g and 57h, the wireless communication between the display device 334 and the housing unit 320” is based on NFC, while the wireless communication between the display device and a further external unit is based on WiFi. As such, the first communication unit of the display device 334 is configured to communicate wirelessly with the housing unit 320” using a first communication frequency and the second communication unit of the display device 334 is configured to communicate wirelessly with a further external device using a second different communication frequency. For this purpose, the first communication unit of the display device 334 comprises a first antenna configured for NFCbased wireless communication with the housing unit 320”, and the second communication unit comprises a second antenna configured for WiFi-based wireless communication with a further external device. The first and second antennae may be wire-based antennae or substrate-based antennae. As such, the first communication unit is configured to communicate wirelessly with the housing unit 320” on a first frequency and the second communication unit is configured to communicate wirelessly with the further external device using a second different communication frequency. Also, the first communication unit of the display device 334 is configured to communicate wirelessly with the housing unit 320” using a first communication protocol (the NFC communication protocol), and the second communication unit is configured to communicate wirelessly with the further external device using a second communication protocol (the WiFi communication protocol). The first and second communication protocols are different which adds an additional layer of security as security structures could be built into the electronics and/or software enabling the transfer from a first to a second communication protocol.
[00012] In alternative embodiments, the second communication unit of the display device 334 may be configured to communicate with the further external device by means of, a WLAN type protocol, or a 3G/4G/5G type protocol, or a GSM type protocol.
[00013] In the embodiment shown in figs. 57g and 57h, the communication range of the first communication unit of the housing unit 320” is less than a communication range of the second communication unit of the housing unit 320’, such that the communication distance between the housing unit 320” and the medical implant may be longer than the communication distance between the housing unit 320” and the display device 334. In the embodiment shown in figs. 57g and 57h, the communication range of the first communication unit may be constrained to a length that is less than five times the longest dimension of the minimal bounding box of the display device 334, or more precisely constrained to a length that is less than three times the longest dimension of the minimal bounding box of the display device 334.
[00014] In the embodiment shown in figs. 57g and 57h, communication between the housing unit 320” and the display device 334 is only enabled when the housing unit 320” is connected to the display device 334. 1.e. at least one of the housing unit 320” and the display device 334 is configured to allow communication between the housing unit 320” and the display device 334 on the basis of the distance between the housing unit 320” and the display device 334. In the alternative, the housing unit 320” and/or the display device 334 may comprise a sensor configured to estimate whether the housing unit 320” is attached to the display device 334 or not, such as a mechanically activated switch or a photo resistive sensor which providing sensor input when the housing unit 320” and display device 334 are mechanically connected to each other. The signal from the at least one sensor then may be used to permit usage of the communication unit configured for communication with the display device 334.
[00015] In the embodiment shown in figs. 57g and 57h, communication between the housing unit 320” and the implantable medical device is only enabled on the basis of a distance between the housing unit 320” and the implantable medical device. In the embodiment shown in figs. 57g and 57h, the distance should be less than twenty times the longest dimension of the minimal bounding box of the display device, or more specifically less than ten times the longest dimension of the minimal bounding box of the display device. The distance between the housing unit 320” and the medical implant may be measured using electromagnetic waves, or acoustic waves. The process of measuring the distance may comprise triangulation.
[00016] In the embodiment shown in figs. 57g and 57h, the second communication unit of the display device 334 need to be disabled to enable communication between the display device 334 and the housing unit 320”, and further the second communication unit of the display device 334 needs to be disabled to enable communication between the housing unit 320” and the medical implant. Also, the second communication unit of the housing unit 320” needs to be disabled to enable communication between the housing unit 320” and the medical implant.
[00017] In the embodiment shown in figs. 57g and 57h, the housing unit 320” further comprises an encryption unit configured to encrypt communication received from the display device 334 before transmitting the communication to the implanted medical device. The encryption unit may for example be based on one of the following algorithms: AES, Blowfish, DES, Kalyna, Serpent or Twofish. For the purpose for handling the communication, I/O and encryption, the housing unit 320” comprises a processor which could be a general-purpose microprocessor and/or an instruction set processor and/or related chips sets and/or special purpose microprocessors such as ASICs (Application Specific Integrated Circuit). The processor also comprise memory for storing instruction and/or data. [00018] Figs. 57i and 57j shows an embodiment of the external unit similar to the embodiment described with reference to figs. 57g and 57h. The difference being that in the embodiment of figs. 57i and 57j, the housing unit 320” does not clasp the display device 334. Instead, the housing unit comprises two magnets 1510 for magnetically fixating the display device 334 to the housing unit 320”. In alternative embodiments, it is equally conceivable that the external device comprises an intermediate portion, which is fixedly fixated to the housing unit for providing a detachable connection with the display device 334. In the alternative, the intermediate device could be fixedly fixated to the display device 334 and provide a detachable connection with the housing unit 320”.
[00019] Fig. 57k shows a system overview of the external device (which could be the external device of the embodiment described with reference to figs 57g and 57h, or of the embodiment described with reference to figs 57i and 57j). The housing unit 320” is connected to the display device 334. A wireless connection 413 is provided between the housing unit 320” and the display device 334, and a further wireless connection 413 is provided between the housing unit 320” and the implanted medical device 100, such that the housing unit can send instructions and updates to the implanted medical device 100, and receive information, parameters (such as sensor values) and alarms from the implanted medical device 100. The communication between the external device and the medical implant 100 is further described in other portions of this disclosure. [00020] The implantable medical device 100 may be an active and/or operable implantable medical device 100 which may be an implantable medical device configured to exert a force on a body portion of the patient. The body portion of the patient may be a fluid carrying vessel, an organ, a joint, a membrane, a muscle, a bone or a nerve. The implantable medical device 100 may comprises an electrical motor and a controller for controlling the electrical motor and instructions transmitted to the implantable medical device 100 could be instructions pertaining to the control of the electrical motor. The controller may control, the velocity, the acceleration or the torque of the motor.
A system for mitigating fibrin creation caused by the contact between the implantable medical device and the tissue or flowing blood of a patient, will now be described with reference to figures 58A - 62B. The system can be used as a coating for any implantable component of the medical devices disclosed herein, in particular enclosures, operable members and conduits and leads.
All foreign matter implanted into the human body inevitably causes an inflammatory response. In short, the process starts with the implanted medical device immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface enabling monocytes and macrophages to interact on the surface of the medical implant. The macrophages secrete proteins that modulate fibrosis and in turn developing the fibrosis capsule around the foreign body. In practice, a fibrosis capsule is a dense layer of excess fibrous connective tissue. On a medical device implanted in the abdomen, the fibrotic capsule typically grows to a thickness of about 0,5mm - 2mm, and is substantially inelastic and dense.
The body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body and/or blood flowing within the body. Implantation of medical devices and or biomaterial in the tissue of a patient may trigger the body’s foreign body reaction (FBR). FBR leads to a formation of foreign body giant cells and the development of a fibrous capsule enveloping the implant. The formation of a dense fibrous capsule that isolates the implant from the host is the common underlying cause of implant failure. Implantation of medical devices and or biomaterial in a blood flow may also cause the formation of fibrous capsules due to the attraction of certain cells within the blood stream.
Implants may, due to the fibrin formation cause blood clotting leading to complications for the patient. Implants in contact with flowing blood and/or placed in the body may also lead to bacterial infection.
One common way of counteracting the creation of blood clots is by using blood thinners of different sorts. One commonly used blood thinner is called heparin. However, heparin have certain side-effects that are undesirable.
Fibrin is an insoluble protein that is partly produced in response to bleeding and is the major component of blood clots. Fibrin is formed by fibrinogen, a soluble protein that is produced by the liver and found in blood plasma. When tissue damage results in bleeding, fibrinogen is converted at the wound into fibrin by the action of thrombin, a clotting enzyme. The fibrin then forms, together with platelets, a hemostatic plug or clot over a wound site.
The process of forming fibrin from fibrinogen starts with the attraction of platelets. Platelets have thrombin receptors on their surfaces that bind serum thrombin molecules. These molecules can in turn convert soluble fibrinogen into fibrin. The fibrin then forms long strands of tough and insoluble protein bound to the platelets. The strands of fibrin are then cross-linked so that it hardens and contracts, this is enabled by Factor XIII which is a zymogen found in the blood of humans.
Figures 58A - 58C describes the reaction that takes place when a blood vessel is damaged. A blood vessel 700 is damaged and wound 710 appears. The blood contains many different cells and particles, for example red blood cells 720 and platelets 730. When the wound 710 appears red blood cells 720 and platelets 730 start to gather at the wound 710. Due to the thrombin receptors on the surface of the platelets 730 a fibrin sheath 740 starts to form which eventually creates a clot that stops the bleeding.
Fibrin may also be created due to the foreign body reaction. When a foreign body is detected in the body the immune system will become attracted to the foreign material and attempt to degrade it. If this degradation fails, an envelope of fibroblasts may be created to form a physical barrier to isolate the body from the foreign body. This may further evolve into a fibrin sheath, in case the foreign body is an implant this may hinder the function of the implant.
Implants can, when implanted in the body, be in contact with flowing blood. This may cause platelet adhesion on the surface of the implants. The platelets may then cause the fibrinogen in the blood to convert into fibrin creating a sheath on and or around the implant. This may prevent the implant from working properly and may also create blood clots that are perilous for the patient.
Implants not in contact with flowing blood can still malfunction due to fibrin creation. Here the foreign body reaction may be the underlying factor for the malfunction. Further, the implantation of a foreign body into the human body may cause an inflammatory response. The response generally persists until the foreign body has been encapsulated in a relatively dense layer of fibrotic connective tissue, which protects the human body from the foreign body. The process may start with the implant immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface, enabling monocytes and macrophages to interact on the surface of the implant. The macrophages secrete proteins that modulate fibrosis and in turn develop the fibrosis capsule around the foreign body, i.e., the implant. In practice, a fibrosis capsule may be formed of a dense layer of excess fibrous connective tissue. The inelastic properties of the fibrotic capsule may lead to hardening, tightness, deformity, and distortion of the implant, which in severe cases may result in revision surgery.
Any implant that is implanted into the body may trigger the formation of fibrin sheaths.
Figure 59 shows a portion of the implantable system, such as a portion of the vessel member comprising an implant surface 750 and a coating 760 arranged on the surface 750. The coating 760 may be configured to have antibacterial and/or antithrombotic characteristics. Depending on the use of the implantable medical device one or both of these effects may be advantageous. The coating 760 may be arranged on the surface 750 so that the coating shields the surface 750 from direct contact with the host body where the implantable system 10 is inserted.
The coating 760 may comprise at least one layer of a biomaterial. The coating 760 may comprise a material that is antithrombotic. The coating 760 may also comprise a material that is antibacterial. The coating 760 may be attached chemically to the surface 750.
Figure 60 shows a vessel member according to any of the embodiments herein, in crosssection. Since multiple surfaces of the vessel member is in contact with tissue of the body, it may comprise a first coating 760a on the surface facing the outside of the blood vessel and a second coating on the surface facing away from the blood vessel. The coatings 760a and 760b may be similar or have different properties.
Figure 61 shows a portion of a surface of the implantable system 10 with a surface 750. The implantable medical device 10 comprises multiple coatings, 760a, 760b, 760c arranged on the surface. The portion may comprise any number of coatings, the particular embodiment of Figure 61 discloses three layers of coating 760a, 760b, 760c. The second coating 760b is arranged on the first coating 760a. The different coating 760a, 760b, 760c may comprise different materials with different features to prevent either fibrin sheath formation or bacteria gathering at the surface 750. As an example, the first coating 760a may comprise a layer of perfluorocarbon chemically attached to the surface. The second coating 760b may comprise a liquid perfluorocarbon layer arranged on the first coating 760a. Perfluorocarbon is used in medicine application in a variety of fields and may be advantageous for using as a coating layer.
The coatings may comprise any type of substance with antithrombotic, antiplatelet or antibacterial features. Such substances include sortase A, perfluorocarbon and more.
The coatings presented in relation to the figures may also be combined with an surface comprising certain materials that are antibacterial or antithrombotic. For example, some metals have shown to be antibacterial. In case the implant, or at least the surfaces of the implant, are made out of such a metal it may be advantageous in order to reduce bacterial infections. The medical implant or the surface of the implant may be made out of any other suitable metal or material. The surface may for example comprise any of the following metals, or any combination of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.
An implantable medical device can also be coated with a slow releasing anti-fibrotic or antibacterial drug in order to prevent fibrin sheath creation and bacterial inflammation. The drug or medicament may be coated on the surface and be arranged to slowly be released from the implant in order to prevent the creation of fibrin or inflammation. The drug may also be covered in a porous or soluble material that slowly disintegrates in order to allow the drug to be administered into the body and prevent the creation of fibrin. The drug may be any conventional anti-fibrotic or antibacterial drug.
Figure 62A and 62B shows different micropattems on the surface 750 of an implant. In order to improve blood compatibility, the implant materials physical structure may be altered or controlled. By creating a certain topography on the surface 750 of an implant fibrin creation and inflammatory reactions may be inhibited. Figure 62A is an example of a micropattem that mimics the features of sharkskin. The micropattem may have many different shapes, many different depths into the surface 750 of the implant 10 and may be a complement to other coatings or be used individually. In Figure 62B another example of a micropattem is disclosed.
The micropattem may for example be etched into the surface 750 of the implantable system prior to insertion into the body. The surface of the implantable system may for example comprise a metal. The surface may for example comprise any of the following metals, or any combination of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead. This may be advantageous in that these metals have proven to be antibacterial which may ensure that the implant functions better when inserted into the host body. The different aspects or any part of an aspect or different embodiments or any part of an embodiment may all be combined in any possible way. For example, all the embodiments relating to the communication and controlling of the implantable system may be combined with the embodiments relating to the programming of the implantable system, the methods, and systems for improving energy consumption or the power supply. The embodiments relating to the programming of the implantable system may be combined with any of the embodiments relating to improving the energy consumption or the power supply. The embodiments relating to the power supply maybe combined with the methods and systems for improving the energy consumption. Any method or any step of method may be seen also as an apparatus description, as well as, any apparatus embodiment, aspect or part of aspect or part of embodiment may be seen as a method description and all may be combined in any possible way down to the smallest detail. Any detailed description should be interpreted in its broadest outline as a general summary description, and please note that any embodiment or part of embodiment as well as any method or part of method could be combined in any way within the scope of the inventive concept, as defined by the appended claims. All examples herein should be seen as part of the general description and therefore possible to combine in any way in general terms.
In the following, numbered aspect groups 424 - 427 of the present invention are provided. The different aspects are numbered individually within the groups and the references to other aspects relate to aspects within the same group. The scope of protection is however defined by the appended claims.
Aspect 424 - Aneurysm Arch
1. An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially contacting a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
2. The implantable system according to aspect 1, wherein the first and second portions (p 1 ,p2) are materially integrated.
3. The implantable system according to any one of aspects 1 and 2, wherein the adjustable vessel member has an inner portion (IP) and an outer portion (OP), wherein the inner portion (IP) is configured to be placed proximal to the heart of the patient and the outer portion (OP) is configured to be placed distal to the heart of the patient, and wherein the inner portion (IP) has an inner length (IL) in the direction of the length extension (LE) of the aorta, and the outer portion (OP) has an outer length (OL) in the direction of the length extension (LE) of the aorta, and wherein the outer length (OL) is longer than the inner length (IL).
4. The implantable system according to aspect 3, wherein the outer length is at least 1,2 times the length of the inner length (IL).
5. The implantable system according to aspect 3, wherein the outer length is at least 2 mm and the inner length is at least 4 mm.
6. The implantable system according to aspect 3, wherein the outer length is at least 3 mm and the inner length is at least 6 mm.
7. The implantable system according to any one of aspects 3 - 6, wherein adjustable vessel member comprises a first part (169a) comprising the inner portion (IP) and a second part (169b) comprising the outer portion (OP), and wherein the first and second parts (169a, 169b) are adapted to be connected to each other to form at least a portion of the adjustable vessel member (169).
8. The implantable system according to aspect 7, wherein the at least one portion of the adjustable vessel member (169) formed by the connection of the first and second parts (169a, 169b) is adapted to enclose a portion of the aorta at the aortic arch of the patient.
9. The implantable system according to aspect 7 or 8, wherein the first and second parts (169a, 169b) are adapted to be connected to each other such that the joint between the first and second parts (169a, 169b) is substantially parallel to the direction of the blood flow.
//CURVATURE//
10. The implantable system according to any one of the preceding aspects, wherein the inner surface (IS) comprises: a first curvature (cl) configured to follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta, and a second curvature (c2) configured to follow a curvature of the circumference of the aorta, in a cross-sectional plane perpendicular to the length extension (LE) of the aorta.
11. The implantable system according to aspect 10, wherein: the first curvature (cl) has a first radius (rl), the second curvature (c2) has a second radius (r2), and the first radius (rl) is larger than the second radius (r2).
12. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member has an inner portion (IP) and an outer portion (OP), wherein the inner portion (IP) is configured to be placed proximal to the heart of the patient and the outer portion (OP) is configured to be placed distal to the heart of the patient, and wherein the first curvature (cl) is located on the inner surface (ISb) of the outer portion (OP), and the third curvature (c3) is located on the inner surface (ISa) of the inner portion (IP) and is configured to follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta, such that the aorta is placeable between the first and third curvatures (cl,c3), and wherein: the first curvature (cl) has a first radius (rl), the third curvature (c3) has a third radius (r3), and the first radius (rl) is larger than the third radius (r3).
13. The implantable system according to any one of aspects 11 - 12, wherein the first radius (rl) is at least 2 times the second radius (r2).
14. The implantable system according to aspect 12, wherein the first radius (rl) is at least 1,5 times the third radius (r3).
15. The implantable system according to aspect 12, wherein the third radius (r3) is at least 1,5 times the second radius (r2).
16. The implantable system according to any one of aspects 11 - 15, wherein the first radius (rl) is in the range 8mm - 45mm.
17. The implantable system according to any one of aspects 11 - 16, wherein the second radius (r2) is in the range 3mm - 25mm. (4-15, 6-12)
18. The implantable system according to any one of aspects 11 - 17, wherein the third radius (r3) is in the range 5mm - 25mm.
//ANGLE//
19. The implantable system according to any one of the preceding aspects, wherein a first straight line (141a) extends on the inner surface (ISb’) of the first portion (pl), and a second straight line (141b) extends on the inner surface (ISb”) of the second portion (p2), wherein: the first straight line (141a) is connected to the second straight line, and the first straight line (141a) is angled with a first angle (a) in relation to the second straight line.
20. The implantable system according to aspect 19, wherein the first angle (a) is in the range 3° - 90°.
21. The implantable system according to aspect 19, wherein the first angle (a) is in the range 5° - 45°.
22. The implantable system according to any one of aspects 19 - 21, wherein the first straight line has a length exceeding 4mm and the second straight line has a length exceeding 4mm. 23. The implantable system according to any one of aspects 19 - 22, wherein the adjustable vessel member has an inner portion (IP) and an outer portion (OP), wherein the inner portion (IP) is configured to be placed proximal to the heart of the patient and the outer portion (OP) is configured to be placed distal to the heart of the patient, and wherein the first straight line (141a) extends on the inner surface (ISb’) of the first portion (pl) of the outer portion (OP), and the second straight line (141b) extends on the inner surface (ISb”) of the second portion (p2) of the outer portion (OP).
24. The implantable system according to any one of aspects 19 - 23, wherein a third straight line (141c) extends on the inner surface (ISa'. ISb') of the first portion (pl), and a fourth straight line (14 Id) extends on the inner surface (ISa”,ISb”) of the second portion (p2), wherein: the third straight line (141c) is connected to the fourth straight line (14 Id), the third straight line (141c) is angled with a second angle (P) in relation to the fourth straight line (14 Id), and the first angle (a) is different from the second angle (P).
25. The implantable system according to aspect 24, wherein the first angle (a) is smaller than the second angle (P).
26. The implantable system according to aspect 24, wherein the first angle (a) is more than 3° smaller than the second angle (P).
27. The implantable system according to aspect 24, wherein the first angle (a) is more than 5° smaller than the second angle (P).
28. The implantable system according to any one of aspects 24 - 27, wherein the adjustable vessel member has an inner portion (IP) and an outer portion (OP), wherein the inner portion (IP) is configured to be placed proximal to the heart of the patient and the outer portion (OP) is configured to be placed distal to the heart of the patient, and wherein the third straight line (141c) extends on the inner surface (ISa’) of the first portion (pl) of the inner portion (IP), and the fourth straight line (14 Id) extends on the inner surface (ISa”) of the second portion (p2) of the inner portion (OP).
29. The implantable system according to aspect 28, wherein the first straight line (141a) and the third straight line (141c) are configured to extend on opposite sides of the aorta.
//FIRST AND SECOND SEGMENT//
30. The implantable system according to any one of the preceding aspects, wherein the at least one adjustable vessel member comprises a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2).
31. The implantable system according to aspect 30, wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface configured to mate with the first connection interface, such that the first and second segments (S 1 ,S2) can be connected for creating the adjustable vessel member configured to follow the curvature in the direction of the length extension of the aorta. 32. The implantable system according to any of aspects 30 and 31, wherein the first and second segments (S1,S2), when assembled, cover a distance of 5mm - 100mm of the aorta in the direction of length extension (LE) of the aorta.
33. The implantable system according to any one of aspects 30 - 32, wherein the first and second segments (S1,S2) forms a bent channel configured to be placed around at least a portion of the aorta in the region of the aortic arch.
34. The implantable system according to any one of aspects 30 - 33, wherein the first segment (S 1) is angled in relation to the second segment (S2), such that the adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
35. The implantable system according to any one of aspects 30 - 34, wherein the first segment (SI) is displaced in relation to the second segment (S2), such that the adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
36. The implantable system according to any of aspects 30 - 35, wherein the first segment
(51) comprises at least one recess and the second segment comprises at least one protrusion, and wherein the first segment (SI) is connectable to the second segment (S2) by the at least one protrusion being placed in the at least one recess.
37. The implantable system according to any one of aspects 30 - 36, wherein the first and second segments (S 1 ,S2) are adapted to be assembled such that the joint between the first and second segments (S 1 ,S2) is more perpendicular than parallel to the direction of the blood flow.
38. The implantable system according to aspect 37, wherein the first and second segments (S 1 ,S2) are adapted to be assembled such that the joint between the first and second segments
(S 1 ,S2) is substantially perpendicular to the direction of the blood flow.
39. The implantable system according to aspect 38, wherein the adjustable vessel member further comprises a third segment (S3) configured to be connected to the second segment (S2).
40. The implantable system according to any one of aspects 30 - 39, wherein the first segment (SI) has a length in the range 3mm - 30mm and the second segment (S2) has a length in the range 3mm - 30mm.
41. The implantable system according to any one of aspects 30 - 40, wherein the first segment (SI) has a length which is at least 1,2 times the length of a length of the second segment
(52).
42. The implantable system according to aspect 41, wherein the first segment (SI) has a length which is at least 2 times the length of a length of the second segment (S2).
43. The implantable system according to any one of preceding aspects, wherein: a first portion of the adjustable vessel member comprises a first enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the aorta, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the aorta, a second portion of the adjustable vessel member comprises a second enclosing cross- sectional area perpendicular to the direction of the length extension (LE) of the aorta, the second enclosing cross-sectional area being configured for at least partially enclosing a portion of the aorta, and the second enclosing cross-sectional area is larger than the first enclosing cross-sectional area.
44. The implantable system according to aspect 43, wherein: the first segment of the adjustable vessel member comprises the first enclosing cross- sectional area, and the second segment of the adjustable vessel member comprises the second enclosing cross- sectional area.
45. The implantable system according to aspect 44, wherein: a third segment of the vessel member comprises a third enclosing cross-sectional area.
46. The implantable system according to aspect 45, wherein: the third enclosing cross-sectional area is larger than the second enclosing cross-sectional area.
47. The implantable system according to aspect 45, wherein: the third enclosing cross-sectional area is smaller than the second enclosing cross-sectional area.
48. The implantable system according to any one of the preceding aspects, wherein the at least one opening or the at least one recess in positioned: at a joint between two or more segments of the adjustable vessel member, or at a joint between two or more parts of the adjustable vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
//OPENINGS / FURROW//
49. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member can be at least partially opened for being introduced over the aorta for at least partially enclosing the aorta.
50. The implantable system according to aspect 49, wherein the adjustable vessel member comprises at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the aorta for at least partially enclosing the aorta.
51. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least one of: an opening for accommodating at least one blood vessel connected to the aorta, and a recess for accommodating at least one blood vessel connected to the aorta.
52. The implantable system according to aspect 51, wherein the at least one opening comprises at least one through-hole for accommodating the at least one blood vessel connected to the aorta.
53. The implantable system according to aspect 51, wherein the at least one opening comprises at least one slit for accommodating the at least one blood vessel connected to the aorta.
54. The implantable system according to any one of the preceding aspects, further comprising a third portion, wherein: the first portion (Pl) of the adjustable vessel member is configured to encircle the aorta, the second portion (P2) of the adjustable vessel member comprises at least one opening for accommodating at least one blood vessel connected to the aorta, and the third portion of the adjustable vessel member is configured to encircle the aorta.
55. The implantable system according to any one of aspects 51 - 54, wherein the at least one blood vessel connected to the aorta is at least one branch from the aorta.
56. The implantable system according to aspect 55, wherein the at least one blood vessel connected to the aorta is at least one of the: brachiocephalic artery, the left common carotid artery and the left subclavian artery.
57. The implantable system according to any one of aspects 51 - 56, wherein the distance between an edge of the at least one opening and the at least one blood vessel connected to the aorta is configured to be between 1mm and 10mm.
58. The implantable system according to any one of aspects 51 - 57, wherein the at least one opening is annular.
59. The implantable system according to aspect 58, wherein the annular opening has a diameter in the range of 1mm - 10mm.
60. The implantable system according to any one of aspects 51 - 59, wherein the adjustable vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
61. The implantable system according to any one of aspects 51 - 60, wherein the recess comprises at least one furrow adapted to accommodate the at least one blood vessel connected to the aorta.
62. The implantable system according to aspect 61, wherein the furrow extends substantially in the direction of the length extension (LE) of the aorta.
63. The implantable system according to aspect 61, wherein the furrow extends in a direction at an angle in relation to the direction of the length extension (LE) of the aorta, the angle being an angle in the range 10° - 45°. 64. The implantable system according to any one of aspects 51 - 63, wherein the recess extends on an inner surface of the adjustable vessel member, such that the recess accommodates the blood vessel connected to the aorta between the adjustable vessel member and the aorta.
65. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other.
66. The implantable system according to any one of aspects 51 - 65, wherein the adjustable vessel member comprises at least one recess connected to at least one opening, such that the blood vessel connected to the aorta can extend in the recess and further through the opening.
67. The implantable system according to any one of aspects 51 - 66, wherein the first and second segments of any one of aspects 30 - 42 comprises the opening.
68. The implantable system according to aspect 67, wherein the first and second segments comprises a through hole.
69. The implantable system according to aspect 67, wherein the first and second segments comprises a slit.
70. The implantable system according to any one of aspects 51 - 69, wherein the first and second segments of any one of aspects 30 - 48 comprises the recess for accommodating the blood vessel connected to the aorta.
71. The implantable system according to any one of aspects 51 - 70, wherein the first and second segments of any one of aspects 30 - 48 comprises a furrow.
72. The implantable system according to any one of aspects 51 - 71, wherein: the first segment of any one of aspects 30 - 48 comprises at least one of a first opening and a first recess for accommodating at least one first blood vessel connected to the aorta, and the second segment of any one of aspects 30 - 48 comprises at least one of a second opening and a second recess for accommodating at least one second blood vessel connected to the aorta.
73. The implantable system according to aspect 72, wherein: the at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess are radially displaced at an angle in relation to each other, in relation to the aorta, along a center axis of the aorta.
74. The implantable system according to aspect 73, wherein the angle is an angle in the range 10° - 180° .
75. The implantable system according to any one of aspects 51 - 74, wherein the at least one opening or the at least one recess in positioned: at a joint between two or more segments of the vessel member, or at a joint between two or more parts of the vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
76. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the aorta.
77. The implantable system according to aspect 76, wherein the at least one branch supporting element is configured to encircle a branching blood vessel.
//PRESSURE OR DISTANCE//
78. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member is configured to be placed at a distance from the aorta, such that the inner surface does not engage the outer surface of the aorta.
79. The implantable system according to aspect 78, wherein the adjustable vessel member is configured to be placed at a distance in the interval 0,5mm - 3mm from the aorta, such that the inner surface does not engage the outer surface of the aorta.
80. The implantable system according to any one of aspects 1 - 78, wherein the inner surface of the adjustable vessel member is configured to engage the outer surface of the aorta.
81. The implantable system according to any one of the preceding aspects, wherein the inner surface of the adjustable vessel member comprises at least one inflatable portion at least partially facing the outer surface of the aorta.
82. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member is adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
83. The implantable system according to any one of aspects 81 - 82, wherein the inflatable portion is connected to a valve for controlling the flow of a fluid to and from the inflatable portion.
84. The implantable system according to any one of aspects 30 - 83, wherein the first segment comprises a first inflatable portion and the second segment comprises a second inflatable portion.
85. The implantable system according to aspect 84, wherein the first inflatable portion is connected to a first valve for controlling the flow of a fluid to and from the first inflatable portion and the second inflatable portion is connected to a second valve for controlling the flow of a fluid to and from the second inflatable portion.
86. The implantable system according to any one of aspects 84 and 85, further comprising a conduit for creating a fluid connection between the first and second inflatable portion.
87. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises an elastic material.
88. The implantable system according to aspect 87, wherein the vessel member is adapted to exert a mechanical pressure by the elastic properties of the elastic material. 89. The implantable system according to any one of aspects 30 - 88, wherein the first segment is configured to exert a first pressure on the aorta and the second segment is configured to exert a second pressure on the aorta, and wherein the first and second pressures are individually adjustable.
90. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member is configured to exert an adjustable pressure on the aorta, and wherein the system further comprises an implantable controller for adjusting the pressure exerted on the aorta by the adjustable vessel member.
91. The implantable system according to any one of the preceding aspects, wherein the operation device comprises a hydraulic operation device, and wherein the implantable system further comprises an expandable hydraulic reservoir.
92. The implantable system according to aspect 91, wherein the expandable hydraulic reservoir is in fluid connection with an inflatable portion of the adjustable vessel member, and wherein the pressure exerted on the aorta from the inflatable member can be controlled by controlling a flow of fluid from the expandable hydraulic reservoir to the inflatable portion.
93. The implantable system according to aspect 92, further comprising a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion via the fluid connection for adjusting the pressure exerted on the aorta from the inflatable member, and wherein the pump is connected to the controller such that the controller can control the operation of the pump.
94. The implantable system according to any one of the preceding aspects, wherein the operation device comprises a mechanical operation device configured to adjust the pressure exerted by the adjustable vessel member on the aorta.
95. The implantable system according to aspect 94, wherein the mechanical operation device comprises an electrical motor configured to adjust the pressure exerted by the adjustable vessel member on the aorta.
96. The implantable system according to any one of the preceding aspects, wherein the at least one adjustable vessel member comprises an enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the aorta, the enclosing cross-sectional area being configured for at least partially enclosing a portion of the aorta.
97. The implantable system according to aspect 96, wherein the mechanical operation device is adapted to adjust the pressure exerted by the adjustable vessel member on the aorta by altering the size of the enclosing cross-section area.
98. The implantable system according to aspect 96, wherein the hydraulic operation device is adapted to adjust the pressure exerted by the adjustable vessel member on the blood vessel by altering the size of the enclosing cross-section area.
//SENSOR// 99. The implantable system according to any one of aspects 90 - 98, further comprising at least one sensor connected to the implantable controller.
100. The implantable system according to aspect 99, wherein the sensor is a sensor configured to sense a physical parameter of the implantable system.
101. The implantable system according to aspect 100, wherein the sensor is configured to sense a physical parameter of the implantable system comprising at least one of: a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
102. The implantable system according to aspect 101, wherein the sensor configured to sense a parameter related to strain in the implantable system is configured to sense a strain in the adjustable vessel member connected to the expansion of the aneurysm.
103. The implantable system according to aspect 101, wherein the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the adjustable vessel member.
104. The implantable system according to aspect 101, wherein the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the adjustable vessel member.
105. The implantable system according to any one of aspects 99 - 104, wherein the inner surface of the adjustable vessel member comprises the sensor or is connected to the sensor.
106. The implantable system according to any one of aspects 99 - 104, wherein the sensor is connected to the expandable hydraulic reservoir, and wherein the sensor is configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
107. The implantable system according to any one of aspects 99 - 106, wherein the sensor is connected to the inflatable portion, and wherein the sensor is configured to sense an expansion of the aneurysm by sensing at least one of a pressure change and a volume change in the inflatable portion.
108. The implantable system according to aspect 99, wherein the sensor is configured to sense at least one physiological parameter of the patient.
109. The implantable system according to aspect 108, wherein the sensor is a sensor configured to sense at least one of: an expansion of the aneurysm, a size of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
110. The implantable system according to aspect 109, wherein the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of the aorta, a wall thickness of the aorta, a flow rate through the aorta, or an optical parameter related to the state of the aorta.
111. The implantable system according to any one of aspects 99 - 110, wherein the implantable controller is configured to transmit information based on sensor input to a source external to the body of the patient.
112. The implantable system according to aspect 111, wherein the controller is configured to transmit the information based on sensor input to a source external to the body of the patient, wirelessly.
//ATTACHEMENT//
113. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises an attachment device (30) for attaching the adjustable vessel member to a portion of the body of the patient.
114. The implantable system according to any one of aspects 30 - 113, wherein the adjustable vessel member comprises a first attachment device (30X) for attaching the first segment to a portion of the body of the patient and a second attachment device (3 OX) for attaching the second segment to a portion of the body of the patient.
115. The implantable system according to any one of aspects 113 - 114, wherein the attachment device is configured to attach the adjustable vessel member to a portion of the body of the patient comprising bone.
//REMOTE UNIT//
116. The implantable system according to any one of the preceding aspects, further comprising a remote unit connected to the adjustable vessel member, wherein a major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the adjustable vessel member. 117. The implantable system according to aspect 116, wherein the remote unit comprises at least a portion of the operation device.
118. The implantable system according to any one of aspects 116 - 117, further comprising a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the adjustable vessel member, for operating the adjustable vessel member.
119. The implantable system according to any one of aspects 116 - 118, wherein the adjustable vessel member comprises at least part of the operation device.
120. The implantable system according to aspect 119, wherein the part of the operation device comprised in the adjustable vessel member comprises a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the aorta.
121. The implantable system according to aspect 120, wherein the receiving portion is configured to receive a linear mechanical force.
122. The implantable system according to aspect 121, wherein the receiving portion is configured to receive a rotating mechanical force, and wherein the transmission is configured to transform the received rotating mechanical force into a liner mechanical force.
123. The implantable system according to any one of aspect 120 - 122, wherein the transmission comprises a gear system configured to reduce the velocity and increase the force of the received mechanical force.
124. The implantable system according to any one of aspects 117 - 123, wherein the portion of the operation device placed in the remote unit comprises an electrical motor.
125. The implantable system according to aspect 124, wherein the portion of the operation device placed in the remote unit further comprises a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
126. The implantable system according to any one of aspects 119 - 125, wherein the portion of the operation device placed in the adjustable vessel member comprises a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the vessel.
127. The implantable system according to aspect 126, wherein the transmission comprises at least one hydraulic cylinder.
128. The implantable system according to any one of aspects 119 - 127, wherein the portion of the operation device placed in the adjustable vessel member comprises a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
129. The implantable system according to any one of aspects 117 - 127, wherein the portion of the operation device placed in the remote unit comprises at least one operable valve for controlling a flow of hydraulic fluid. 130. The implantable system according to any one of aspects 128 and 129, wherein the operable valve is configured to control the flow of hydraulic fluid between at least one of: the expandable hydraulic reservoir and the first inflatable member, the expandable hydraulic reservoir and the second inflatable member, and the first inflatable member and the second inflatable member.
131. The implantable system according to any one of aspects 117 - 130, wherein the portion of the operation device placed in the remote unit comprises at least one hydraulic pump.
132. The implantable system according to any one of aspects 116 - 131, wherein the remote unit comprises a hydraulic reservoir for holding a hydraulic fluid.
133. The implantable system according to any one of aspects 116 - 132, wherein the remote unit comprises an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
134. The implantable system according to any one of aspects 116 - 133, wherein the remote unit further comprises an energy storage unit for directly or indirectly energizing the implantable system.
135. The implantable system according to any one of aspects 116 - 134, wherein the remote unit further comprises the implantable controller.
136. The implantable system according to aspect 135, wherein the controller comprises a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
137. The implantable system according to any one of aspects 116 - 136, wherein the implantable system further comprises at least one lead for transferring electrical energy and/or information from the remote unit to the adjustable vessel member.
138. The implantable system according to any one of aspects 116 - 137, wherein the implantable system further comprises a housing configured to enclose the remote unit.
139. The implantable system according to aspect 138, wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
140. The implantable system according to aspect 139, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
141. The implantable system according to any one of aspects 116 - 140, wherein the remote unit comprises: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion, wherein: the first, second and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
142. The implantable system according to aspect 141, wherein at least one of: the first portion is detachably connected to the connecting portion, and the second portion is detachably connected to the connecting portion.
143. An implantable system according to aspect 1-141, wherein the at least one adjustable vessel member is configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient.
144. A method of implanting an implantable system for handling an aneurysm in a blood vessel of a patient, the method comprising: making an incision in the body of the patient for accessing a vessel having an aneurysm, dissecting a portion of the vessel, and placing at least one vessel member according to any one of aspects 1 - 143 in connection with or adjacent to the blood vessel.
145. The method according to aspect 144, further comprising the step of connecting two or more parts for forming the vessel member.
146. The method according to any one of aspects 144 and 145, further comprising the step of placing at least one branching blood vessel in an opening or recess in the vessel member.
147. The method according to any one of aspects 144 - 146, further comprising placing a remote unit connected to the vessel member at a distance exceeding 80mm from a major portion of the vessel member.
148. The method according to any one of aspects 144 - 147, further comprising attaching the adjustable vessel member to a portion of the body of the patient.
149. The method according to any one of aspects 144 - 148, wherein the step of placing at least one vessel member according to any one of aspects 1 - 143 in connection with or adjacent to the blood vessel, comprises placing at least one vessel member according to any one of aspects 1 - 143 in connection with or adjacent to the aortic arch. Aspect 425 - Aneurysm Segments
1. An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially contacting a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
2. The implantable system according to aspect 1, wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the curvature in the direction of the length extension (LE) of the blood vessel.
3. The implantable system according to aspect 2, wherein the first segment (SI) comprises at least one recess and the second segment (S2) comprises at least one protrusion, and wherein the first segment (SI) is connectable to the second segment (S2) by the at least one protrusion being placed in the at least one recess.
4. The implantable system according to any one of aspects 1 - 3, wherein the first and second segments (S1,S2), when assembled, cover a distance of 5mm - 100mm of the blood vessel, in the direction of length extension (LE) of the blood vessel.
5. The implantable system according to any one of the preceding aspects, wherein the first segment (SI) has a length which is at least 1,2 times the length of a length of the second segment (S2).
6. The implantable system according to aspect 5, wherein the first segment (SI) has a length which is at least 2 times the length of a length of the second segment (S2). 7. The implantable system according to any one of aspects 1 - 6, wherein the first and second segments (S1,S2) forms a bent channel configured to be placed around at least a portion of the blood vessel.
8. The implantable system according to any one of aspects 1 - 7, wherein the first and second segments (S 1,S2) are adapted to be assembled such that the joint between the first and second segments (S 1 ,S2) is more perpendicular than parallel to the direction of the length extension (LE) of the blood vessel.
9. The implantable system according to aspect 8, wherein the first and second segments (S 1 ,S2) are adapted to be assembled such that the joint between the first and second segments (S 1 ,S2) is substantially perpendicular to the direction of the length extension (LE) of the blood vessel.
10. The implantable system according to any one of the preceding aspects, wherein the vessel member further comprises a third segment (S3) configured to be connected to the second segment (S2).
11. The implantable system according to any one of the preceding aspects, wherein the first segment (SI) has a length in the range 3mm - 30mm and the second segment (S2) has a length in the range 3mm - 30mm.
12. The implantable system according to any one of the preceding aspects, wherein at least one of the first and second segments (S 1 ,S2) comprises a first part (169a) comprising the inner portion (IP) and a second part (169b) comprising the outer portion (OP), and wherein the first and second parts (169a, 169b) are adapted to be connected to each other to enclose a portion of the blood vessel.
13. The implantable system according to aspect 12, wherein the first and second parts (169a, 169b) are adapted to be connected to each other such that the joint between the inner and outer parts (169a, 169b) is substantially parallel to the direction of the blood flow.
14. The implantable system according to any one of the preceding aspects, wherein the inner surface (IS) comprises: a first curvature (cl) configured to follow the curvature of the curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel, and a second curvature (c2) configured to follow a curvature of the circumference of the blood vessel, in a cross-sectional plane perpendicular to the length extension (LE) of the blood vessel.
15. The implantable system according to aspect 14, wherein: the first curvature (cl) has a first radius (rl), the second curvature (c2) has a second radius (r2), and the first radius (rl) is larger than the second radius (r2).
16. The implantable system according to aspect 15, wherein the first radius (rl) is at least 2 times the second radius (r2). 17. The implantable system according to any one of aspects 15 - 16, wherein the first radius (rl) is in the interval 10mm - 80mm. (10-60, 20-60)
18. The implantable system according to any one of aspects 15 - 17, wherein the second radius (r2) is in the interval 2mm - 25mm. (4-12, 6-12)
19. The implantable system according to any one of preceding aspects, wherein: a first portion of the vessel member comprises a first enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the blood vessel, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, a second portion of the vessel member comprises a second enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the blood vessel, the second enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, and the second enclosing cross-sectional area is larger than the first enclosing cross-sectional area.
20. The implantable system according to aspect 19, wherein: the first segment of the vessel member comprises the first enclosing cross-sectional area, and the second segment of the vessel member comprises the second enclosing cross-sectional area.
21. The implantable system according to aspect 20, wherein: a third segment of the vessel member comprises a third enclosing cross-sectional area.
22. The implantable system according to aspect 21, wherein: the third enclosing cross-sectional area is larger than the second enclosing cross-sectional area.
23. The implantable system according to aspect 21, wherein: the third enclosing cross-sectional area is smaller than the second enclosing cross-sectional area.
//ANGLE//
24. The implantable system according to any one of the preceding aspects, wherein a first straight line (141a) extends on the inner surface (ISb’) of the first portion (pl), and a second straight line (141b) extends on the inner surface (ISb”) of the second portion (p2), wherein: the first straight line (141a) is connected to the second straight line, and the first straight line (141a) is angled with a first angle (a) in relation to the second straight line.
25. The implantable system according to aspect 24, wherein the first angle (a) is in the range 3° - 90°. 26. The implantable system according to aspect 25, wherein the first angle (a) is in the range 5° - 45°.
27. The implantable system according to any one of aspects 24 - 26, wherein the first straight line has a length exceeding 4mm and the second straight line has a length exceeding 4mm.
28. The implantable system according to any one of aspects 24 - 27, wherein the vessel member has an inner portion (IP) and an outer portion (OP), and wherein the first straight line (141a) extends on the inner surface (ISb’) of the first portion (pl) of the outer portion (OP), and the second straight line (141b) extends on the inner surface (ISb”) of the second portion (p2) of the outer portion (OP).
29. The implantable system according to any one of aspects 24 - 28, wherein a third straight line (141c) extends on the inner surface (ISa'. ISb') of the first portion (pl), and a fourth straight line ( 14 Id) extends on the inner surface (ISa”,ISb”) of the second portion (p2), wherein: the third straight line (141c) is connected to the fourth straight line (14 Id), the third straight line (141c) is angled with a second angle (P) in relation to the fourth straight line (14 Id), and the first angle (a) is different from the second angle (P).
30. The implantable system according to aspect 29, wherein the first angle (a) is smaller than the second angle (P).
31. The implantable system according to aspect 30, wherein the first angle (a) is more than 3° smaller than the second angle (P).
32. The implantable system according to any one of aspects 29 - 31, wherein the vessel member has an inner portion (IP) and an outer portion (OP), and wherein the third straight line (141c) extends on the inner surface (ISa’) of the first portion (pl) of the inner portion (IP), and the fourth straight line ( 14 Id) extends on the inner surface (ISa”) of the second portion (p2) of the inner portion (OP).
33. The implantable system according to aspect 32, wherein the first straight line (141a) and the third straight line (141c) are configured to extend on opposite sides of the blood vessel.
//OPENINGS / FURROW//
34. The implantable system according to any one of the preceding aspects, wherein at least one of the segments can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
35. The implantable system according to aspect 34, wherein at least one of the segments comprises at least one pivot joint for enabling the at least one segment to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
36. The implantable system according to any one of the preceding aspects, wherein at least one of the segments comprising at least one of: the opening for accommodating the at least one branching blood vessel, and the recess for accommodating the at least one branching blood vessel.
37. The implantable system according to aspect 36, wherein the at least one opening comprises at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel.
38. The implantable system according to aspect 36, wherein the at least one opening comprises at least one slit for accommodating the at least one branching blood vessel connected to the blood vessel.
39. The implantable system according to any one of the preceding aspects, further comprising a third segment comprising a third connection interface configured to mate with the second connection interface of the second segment, such that the first, second and third segments (S1,S2,S3) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, wherein: the first segment (SI) of the vessel member is configured to encircle the blood vessel, the second segment (S2) of the vessel member comprises at least one opening for accommodating at least one branching blood vessel connected to the blood vessel, and the third segment (S3) of the vessel member is configured to encircle the blood vessel.
40. The implantable system according to any one of the preceding aspects, wherein the blood vessel is the aorta.
41. The implantable system according to aspect 35, wherein the at least one branching blood vessel is at least one of: the Brachiocephalic artery, the left common Carotid artery, the left Subclavian artery, the Intercostal arteries, the Bronchial arteries, the Mediastinal arteries, the Esophageal arteries, the Pericardial arteries, the Phrenic arteries, the Celiac trunk, the Suprarenal arteries, the Renal arteries, the Mesenteric arteries, the Gonadal arteries, and the Lumbar arteries.
42. The implantable system according to any one of aspects 36 - 41, wherein the distance between an edge of the at least one opening and the at least one branching blood vessel connected to the blood vessel is configured to be between 1mm and 10mm.
43. The implantable system according to any one of aspects 36 - 41, wherein the at least one opening is annular.
44. The implantable system according to aspect 43, wherein the annular opening has a diameter in the range of 1mm - 10mm.
45. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
//RECESS//
46. The implantable system according to any one of the preceding aspects, wherein the recess comprises at least one furrow adapted to accommodate at least one branching blood vessel. 47. The implantable system according to aspect 46, wherein the furrow adapted to accommodate the at least one branching blood vessel extends substantially in the direction of the length extension (LE) of the blood vessel.
48. The implantable system according to aspect 46, wherein the furrow adapted to accommodate the at least one branching blood vessel extends in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
49. The implantable system according to any one of the preceding aspects, wherein the recess extends on an inner surface of the vessel member, such that the recess accommodates the branching blood vessel between the vessel member and the blood vessel.
50. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other.
51. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least one recess connected to at least one opening, such that a branching blood vessel can extend in the recess and further through the opening.
52. The implantable system according to any one of aspects 36 - 51, wherein the first and second segments comprises the opening.
53. The implantable system according to aspect 52, wherein the first and second segments comprises the through hole.
54. The implantable system according to aspect 52, wherein the first and second segments comprises the slit.
55. The implantable system according to any one of aspects 36 - 54, wherein the first and second segments comprises the recess for accommodating the at least one branching blood vessel.
56. The implantable system according to aspect 55, wherein the first and second segments comprises a furrow.
57. The implantable system according to any one of aspects 36 - 56, wherein: the first segment comprises at least one of a first opening and a first recess for accommodating at least one first branching blood vessel, and the second segment comprises at least one of a second opening and a second recess for accommodating at least one second branching blood vessel.
58. The implantable system according to aspect 57, wherein: the at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess are radially displaced at an angle in relation to each other, in relation to the blood vessel, along a center axis of the blood vessel. 59. The implantable system according to aspect 58, wherein the angle is an angle in the range 10° - 180°.
60. The implantable system according to any one of aspects 34 - 59, wherein the at least one opening or the at least one recess in positioned: at a joint between two or more segments of the vessel member, or at a joint between two or more parts of the vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
61. The implantable system according to any one the preceding aspects, wherein the vessel member comprises at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the blood vessel.
62. The implantable system according to aspect 61, wherein the at least one branch supporting element is configured to encircle a branching blood vessel.
//PRESSURE OR DISTANCE//
63. The implantable system according to any one of the preceding aspects, wherein the vessel member is configured to be placed at a distance from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel.
64. The implantable system according to aspect 63, wherein the vessel member is configured to be placed at a distance in the interval 0,5mm - 3mm from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel.
65. The implantable system according to any one of aspects 1 - 62, wherein the inner surface of the vessel member is configured to engage the outer surface of the blood vessel.
66. The implantable system according to any one of the preceding aspects, wherein the inner surface of the vessel member comprises at least one inflatable portion at least partially facing the outer surface of the blood vessel.
67. The implantable system according to any one of the preceding aspects, wherein the vessel member is adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
68. The implantable system according to any one of aspects 66 - 67, wherein the operation device comprises at least one valve for controlling the flow of a fluid to and from the inflatable portion.
69. The implantable system according to any one of the preceding aspects, wherein the first segment comprises a first inflatable portion and the second segment comprises a second inflatable portion.
70. The implantable system according to aspect 69, wherein the operation device comprises: a first valve for controlling the flow of a fluid to and from the first inflatable portion, and a second valve for controlling the flow of a fluid to and from the second inflatable portion.
71. The implantable system according to any one of aspects 69 and 70, further comprising a conduit for creating a fluid connection between the first and second inflatable portion.
72. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises an elastic material.
73. The implantable system according to aspect 72, wherein the vessel member is adapted to exert a mechanical pressure by the elastic properties of the elastic material.
74. The implantable system according to any one of the preceding aspects, wherein the first segment is configured to exert a first pressure on the blood vessel and the second segment is configured to exert a second pressure on the blood vessel, and wherein the first and second pressures are individually adjustable.
75. The implantable system according to any one of the preceding aspects, further comprising an implantable controller for controlling the operation device.
76. The implantable system according to aspect 75, wherein the implantable controller is configured to control the operation device to adjust the pressure exerted on the blood vessel by the vessel member.
77. The implantable system according to any one of the preceding aspects, wherein the operation device comprises a hydraulic operation device, and wherein the implantable system further comprises an expandable hydraulic reservoir.
78. The implantable system according to aspect 77, wherein the expandable hydraulic reservoir is in fluid connection with the inflatable portion of the vessel member, and wherein the pressure exerted on the blood vessel from the inflatable portion is configured to be adjusted by the operation device creating a flow of fluid from the expandable hydraulic reservoir to the inflatable portion.
79. The implantable system according to aspect 78, wherein the operation device further comprises a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion for adjusting the pressure exerted on the blood vessel from the inflatable member, and wherein the pump is connected to the implantable controller such that the implantable controller can control the operation of the pump.
80. The implantable system according to any one of the preceding aspects, wherein the operation device comprises a mechanical operation device configured to adjust the pressure exerted by the vessel member on the blood vessel.
81. The implantable system according to aspect 80, wherein the mechanical operation device comprises an electrical motor configured to adjust the pressure exerted by the vessel member on the blood vessel.
82. The implantable system according to any one of preceding aspects, wherein the at least one vessel member comprises an enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the blood vessel, the enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel.
83. The implantable system according to aspect 82, wherein the mechanical operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area.
84. The implantable system according to aspect 82, wherein the hydraulic operation device is adapted to adjust the pressure exerted by the vessel member on the blood vessel by altering the size of the enclosing cross-section area.
//SENSOR//
85. The implantable system according to any one of aspects 75 - 84, further comprising at least one sensor connected to the implantable controller.
86. The implantable system according to aspect 85, wherein the sensor is a sensor configured to sense a physical parameter of the implantable system.
87. The implantable system according to aspect 86, wherein the sensor is configured to sense a physical parameter of the implantable system comprising at least one of: a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
88. The implantable system according to aspect 87, wherein the sensor configured to sense a parameter related to strain in the implantable system is configured to sense a strain in the vessel member connected to the expansion of the aneurysm.
89. The implantable system according to aspect 87, wherein the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the vessel member.
90. The implantable system according to aspect 87, wherein the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the vessel member.
91. The implantable system according to any one of aspects 85 - 90, wherein the inner surface of the vessel member comprises the sensor or is connected to the sensor.
92. The implantable system according to any one of aspects 85 - 91, wherein the sensor is connected to the expandable hydraulic reservoir, and wherein the sensor is configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir. 93. The implantable system according to any one of aspects 85 - 92, wherein the sensor is connected to the inflatable portion, and wherein the sensor is configured to sense an expansion of the aneurysm by sensing at least one of a pressure change and a volume change in the inflatable portion.
94. The implantable system according to aspect 85, wherein the sensor is configured to sense at least one physiological parameter of the patient.
95. The implantable system according to aspect 94, wherein the sensor is configured to sense an expansion of the aneurysm.
96. The implantable system according to aspect 94, wherein the physiological parameter is related to the blood pressure of the patient.
97. The implantable system according to aspect 94, wherein the physiological parameter is related to the size of the aneurysm.
98. The implantable system according to aspect 94, wherein the sensor is a sensor configured to sense at least one of: an expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
99. The implantable system according to aspects 98, wherein the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
100. The implantable system according to any one of aspects 85 - 99, wherein the implantable controller is configured to transmit information based on sensor input to a source external to the body of the patient.
101. The implantable system according to aspect 100, wherein the controller is configured to transmit the information based on sensor input to a source external to the body of the patient, wirelessly.
//ATTACHEMENT//
102. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises an attachment device (30) for attaching the vessel member to a portion of the body of the patient. 103. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises a first attachment device (30X) for attaching the first segment (SI) to a portion of the body of the patient and a second attachment device (3 OX) for attaching the second segment (S2) to a portion of the body of the patient.
104. The implantable system according to any one of aspects 102 - 103, wherein the attachment device is configured to attach the vessel member to a portion of the body of the patient comprising bone.
//REMOTE UNIT//
105. The implantable system according to any one of the preceding aspects, further comprising a remote unit connected to the vessel member, wherein a major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
106. The implantable system according to aspect 105, wherein the remote unit comprises at least a portion of the operation device.
107. The implantable system according to any one of aspects 105 - 106, further comprising a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
108. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least part of the operation device.
109. The implantable system according to aspect 108, wherein the part of the operation device comprised in the vessel member comprises a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel.
110. The implantable system according to aspect 109, wherein the receiving portion is configured to receive a linear mechanical force.
111. The implantable system according to aspect 109, wherein the receiving portion is configured to receive a rotating mechanical force, and wherein the transmission is configured to transform the received rotating mechanical force into a liner mechanical force.
112. The implantable system according to any one of aspect 109 - 111, wherein the transmission comprises a gear system configured to reduce the velocity and increase the force of the received mechanical force.
113. The implantable system according to any one of aspects 106 - 112, wherein the portion of the operation device placed in the remote unit comprises an electrical motor.
114. The implantable system according to aspect 113, wherein the portion of the operation device placed in the remote unit further comprises a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor. 115. The implantable system according to any one of aspects 108 - 114, wherein the portion of the operation device placed in the vessel member comprises a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel.
116. The implantable system according to aspect 115, wherein the transmission comprises at least one hydraulic cylinder.
117. The implantable system according to any one of aspects 108 - 116, wherein the portion of the operation device placed in the vessel member comprises a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
118. The implantable system according to any one of aspects 106 - 117, wherein the portion of the operation device placed in the remote unit comprises at least one operable valve for controlling a flow of hydraulic fluid.
119. The implantable system according to any one of aspects 117 and 118, wherein the operable valve is configured to control the flow of hydraulic fluid between at least one of: the expandable hydraulic reservoir and the first inflatable portion, the expandable hydraulic reservoir and the second inflatable portion, and the first inflatable member and the second inflatable portion.
120. The implantable system according to any one of aspects 106 - 117, wherein the portion of the operation device placed in the remote unit comprises at least one hydraulic pump.
121. The implantable system according to any one of aspects 105 - 120, wherein the remote unit comprises a hydraulic reservoir for holding a hydraulic fluid.
122. The implantable system according to any one of aspects 105 - 121, wherein the remote unit comprises an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
123. The implantable system according to any one of aspects 105 - 122, wherein the remote unit further comprises an energy storage unit for directly or indirectly energizing the implantable system.
124. The implantable system according to any one of aspects 105 - 123, wherein the remote unit further comprises the implantable controller.
125. The implantable system according to aspect 124, wherein the implantable controller comprises a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
126. The implantable system according to any one of aspects 105 - 125, wherein the implantable system further comprises at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member. 127. The implantable system according to any one of aspects 105 - 125, wherein the implantable system further comprises a housing configured to enclose the remote unit.
128. The implantable system according to aspect 127, wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
129. The implantable system according to aspect 128, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
130. The implantable system according to any one of aspects 105 - 129, wherein the remote unit comprises: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion, wherein: the first, second and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
131. The implantable system according to aspect 130, wherein at least one of: the first portion is detachably connected to the connecting portion, and the second portion is detachably connected to the connecting portion.
132. An implantable system according to aspect 1-131, wherein the at least one adjustable vessel member is configured for at least partially enclosing a portion of the aneurysm.
133. A method of implanting an implantable system for handling an aneurysm in a blood vessel of a patient, the method comprising: making an incision in the body of the patient for accessing a vessel having an aneurysm, dissecting a portion of the vessel, and placing at least one vessel member according to any one of aspects 1 - 132 in connection with or adjacent to the blood vessel.
134. The method according to aspect 133, further comprising the step of connecting two or more parts for forming the vessel member.
135. The method according to any one of aspects 133 and 134, further comprising the step of placing at least one branching blood vessel in an opening or recess in the vessel member. 136. The method according to any one of aspects 133 - 135, further comprising placing a remote unit connected to the vessel member at a distance exceeding 80mm from a major portion of the vessel member.
137. The method according to any one of aspects 133 - 136, further comprising attaching the adjustable vessel member to a portion of the body of the patient.
138. The method according to any one of aspects 133 - 137, wherein the step of placing at least one vessel member according to any one of aspects 1 - 132 in connection with or adjacent to the blood vessel, comprises placing at least one vessel member according to any one of aspects 1 - 132 in connection with or adjacent to the aortic arch.
Aspect 426 - Aneurysm Branches
1. An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially contacting a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
//OPENING//
2. The implantable system according to aspect 1, wherein the at least one opening comprises at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel.
3. The implantable system according to aspect 2, wherein the through-hole has a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
4. The implantable system according to any one of aspects 2 - 3 , wherein the through-hole is annular.
5. The implantable system according to aspect 4, wherein the annular through-hole has a diameter in the range 1mm - 10mm.
6. The implantable system according to any one of the preceding aspects, wherein the at least one opening comprises at least one slit for accommodating the at least one branching blood vessel. 7. The implantable system according to aspect 6, wherein the slit adapted to accommodate at least one branching blood vessel extends substantially in the direction of the length extension (LE) of the blood vessel.
8. The implantable system according to aspect 6, wherein the slit adapted to accommodate at least one branching blood vessel extends in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
9. The implantable system according to any one of the preceding aspects, wherein the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm.
10. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
//RECESS//
11. The implantable system according to any one of the preceding aspects, wherein the recess comprises at least one furrow adapted to accommodate at least one branching blood vessel.
12. The implantable system according to aspect 11, wherein the furrow adapted to accommodate the at least one branching blood vessel extends substantially in the direction of the length extension (LE) of the blood vessel.
13. The implantable system according to aspect 11, wherein the furrow adapted to accommodate the at least one branching blood vessel extends in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
14. The implantable system according to any one of the preceding aspects, wherein the recess extends on an inner surface of the adjustable vessel member, such that the recess accommodates the branching blood vessel between the adjustable vessel member and the blood vessel.
15. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other.
16. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least one recess connected to at least one opening, such that a branching blood vessel can extend in the recess and further through the opening.
//FIRST AND SECOND SEGMENT//
17. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises a first segment (SI) and a second segment (S2), wherein the first segment (SI) comprises a first connection interface and the second segment (S2) comprises a second connection interface, and wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for at least partially forming the adjustable vessel member.
18. The implantable system according to aspect 17, wherein the first segment (SI) comprises a first portion (Pl) configured to encircle the blood vessel and the second segment comprises a second portion (P2) comprising at least one of: the opening for accommodating the at least one branching blood vessel, and the recess for accommodating the at least one branching blood vessel.
19. The implantable system according to any of aspects 17 and 18, wherein the first and second segments (S 1 ,S2), when assembled, cover a distance of 5mm - 100mm of the blood vessel in the direction of the length extension (LE) of the blood vessel.
20. The implantable system according to any one of aspects 17 - 19, wherein the first and second segments (S 1 ,S2) forms a bent channel configured to be placed around at least a portion of the blood vessel.
21. The implantable system according to any of aspects 17 - 20, wherein the first segment (SI) comprises at least one recess and the second segment comprises at least one protrusion, and wherein the first segment (SI) is connectable to the second segment (S2) by the at least one protrusion being placed in the at least one recess.
22. The implantable system according to any one of aspects 17 - 21, wherein the first and second segments (S 1 ,S2) are adapted to be assembled such that the joint between the first and second segments (S 1 ,S2) is more perpendicular than parallel to the direction of the length extension (LE) of the blood vessel.
23. The implantable system according to aspect 22, wherein the first and second segments (S 1 ,S2) are adapted to be assembled such that the joint between the first and second segments
(S 1 ,S2) is substantially perpendicular to the direction of the length extension (LE) of the blood vessel.
24. The implantable system according to any one of aspects 17 - 23, wherein the first segment (S 1) is angled in relation to the second segment (S2), such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
25. The implantable system according to any one of aspects 17 - 24, wherein the first segment (SI) is displaced in relation to the second segment (S2), such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
26. The implantable system according to any one of aspects 17 - 25, wherein the first segment (SI) has a length in the range 3mm - 30mm and the second segment (S2) has a length in the range 3mm - 30mm. 27. The implantable system according to any one of aspects 17 - 26, wherein the first segment (SI) has a length which is at least 1,2 times the length of a length of the second segment (S2).
28. The implantable system according to aspect 27, wherein the first segment (SI) has a length which is at least 2 times the length of a length of the second segment (S2).
29. The implantable system according to any one of aspects 17 - 28, wherein the first and second segments comprises the opening.
30. The implantable system according to aspect 29, wherein the first and second segments comprises the through hole of any one of aspects 2 - 5.
31. The implantable system according to aspect 29, wherein the first and second segments comprises the slit of any one of aspects 6 - 8.
32. The implantable system according to any one of aspects 17 - 31, wherein the first and second segments comprises the recess for accommodating the at least one branching blood vessel.
33. The implantable system according to any one of aspects 17 - 32, wherein the first and second segments comprises the furrow of any one of aspects 11 - 13.
34. The implantable system according to any one of aspects 17 - 33, wherein: the first segment comprises at least one of a first opening and a first recess for accommodating at least one first branching blood vessel, and the second segment comprises at least one of a second opening and a second recess for accommodating at least one second branching blood vessel.
35. The implantable system according to aspect 34, wherein: the at least one first opening and/or the at least one first recess, and the at least one second opening and/or the at least one second recess are radially displaced at an angle in relation to each other, in relation to the blood vessel, along a center axis of the blood vessel.
36. The implantable system according to aspect 35, wherein the angle is an angle in the range 10° - 180°.
37. The implantable system according to any one of aspects 17 - 36, wherein the adjustable vessel member further comprises a third segment (S3) configured to be connected to the second segment (S2).
38. The implantable system according to aspect 37, wherein the third segment comprises a third portion configured to encircle the blood vessel.
39. The implantable system according to any one of preceding aspects, wherein: a first portion of the adjustable vessel member comprises a first enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the blood vessel, the first enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, a second portion of the adjustable vessel member comprises a second enclosing cross- sectional area perpendicular to the direction of the length extension (LE) of the blood vessel, the second enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, and the second enclosing cross-sectional area is larger than the first enclosing cross-sectional area.
40. The implantable system according to aspect 39, wherein: the first segment of the adjustable vessel member comprises the first enclosing cross- sectional area, and the second segment of the adjustable vessel member comprises the second enclosing cross- sectional area.
41. The implantable system according to aspect 40, wherein: a third segment of the vessel member comprises a third enclosing cross-sectional area.
42. The implantable system according to aspect 41, wherein: the third enclosing cross-sectional area is larger than the second enclosing cross-sectional area.
43. The implantable system according to aspect 41, wherein: the third enclosing cross-sectional area is smaller than the second enclosing cross-sectional area.
44. The implantable system according to any one of the preceding aspects, wherein the at least one opening or the at least one recess in positioned: at a joint between two or more segments of the adjustable vessel member, or at a joint between two or more parts of the adjustable vessel member, such that the at least one opening or the at least one recess forms a portion of the connection interface between the segments or parts.
//ADJUSTABLE VESSEL MEMBER//
45. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
46. The implantable system according to aspect 45, wherein the adjustable vessel member comprises at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
47. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises an inner surface (IS) configured to face an outer surface of the blood vessel, wherein the inner surface (IS) of the adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the blood vessel, such that the inner surface (IS) can follow a curvature of the blood vessel. 48. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises an inner surface (IS) configured to face an outer surface of the blood vessel, wherein the inner surface (IS) of the adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are angled relative to each other, such that the adjustable vessel member can follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
49. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises an inner surface (IS) configured to face an outer surface of the blood vessel, wherein the inner surface (IS) of the adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
50. The implantable system according to any one of aspects 47 - 49, wherein the adjustable vessel member comprises an first part (169a) and an a second part (169b), and wherein the first and second parts (169a, 169b) are adapted to be connected to each other to form at least a portion of the adjustable vessel member (169).
51. The implantable system according to aspect 50, wherein the first and second parts (169a, 169b) are adapted to be assembled such that the joint between the first and second parts (169a, 169b) is more parallel than perpendicular to the direction of the length extension (LE) of the blood vessel.
52. The implantable system according to aspect 51, wherein the first and second parts (169a, 169b) are adapted to be assembled such that the joint between the first and second parts (169a, 169b) is substantially parallel to the direction of the length extension (LE) of the blood vessel.
53. The implantable system according to any one of aspects 47 - 52, wherein the inner surface (IS) comprises: a first curvature (cl) configured to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel, and a second curvature (c2) configured to follow a curvature of the circumference of the blood vessel, in a cross-sectional plane perpendicular to the length extension (LE) of the blood vessel.
54. The implantable system according to aspect 53, wherein: the first curvature (cl) has a first radius (rl), the second curvature (c2) has a second radius (r2), and the first radius (rl) is larger than the second radius (r2).
55. The implantable system according to aspect 54, wherein the first radius (rl) is at least 2 times the second radius (r2). 56. The implantable system according to any one of aspects 54 - 55, wherein the first radius (rl) is in the interval 12mm - 45mm. (15-40, 20-40)
57. The implantable system according to any one of aspects 54 - 56, wherein the second radius (r2) is in the interval 3mm - 25mm. (4-15, 6-12)
58. The implantable system according to any one of aspects 48 - 57, wherein a first straight line (141a) extends on the inner surface (ISb’) of the first portion (pl), and a second straight line (141b) extends on the inner surface (ISb”) of the second portion (p2), wherein: the first straight line (141a) is connected to the second straight line, and the first straight line (141a) is angled with a first angle (a) in relation to the second straight line.
59. The implantable system according to aspect 58, wherein the first angle (a) is in the range 3° - 90°.
60. The implantable system according to aspect 59, wherein the first angle (a) is in the range 5° - 45°.
61. The implantable system according to any one of aspects 58 - 60, wherein the first straight line has a length exceeding 4mm and the second straight line has a length exceeding 4mm.
62. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member has an inner portion (IP) and an outer portion (OP), wherein a first straight line (141a) and a second straight line extends on the inner surface of the inner portion (IP), the first straight line (141a) is connected to the second straight line, and the first straight line (141a) is angled with a first angle (a) in relation to the second straight line, a third straight line (141c) and a fourth straight line extends on the inner surface of the outer portion (IP), the third straight line (141a) is connected to the fourth straight line, and the third straight line (141a) is angled with a second angle (a) in relation to the fourth straight line, and the first angle is different from the second angle.
63. The implantable system according to aspect 62, wherein the first straight line (141a) and the third straight line (141c) are configured to extend on opposite sides of the blood vessel.
64. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least one branch supporting element extending in a direction substantially radially in relation to the length extension of the blood vessel.
65. The implantable system according to aspect 64, wherein the at least one branch supporting element is configured to encircle a branching blood vessel.
//BLOOD VESSEL//
66. The implantable system according to any one of the preceding aspects, wherein the blood vessel is the aorta.
67. The implantable system according to aspect 66, wherein the at least one branching blood vessel is at least one of: the Brachiocephalic artery, the left common Carotid artery, the left Subclavian artery, the Intercostal arteries, the Bronchial arteries, the Mediastinal arteries, the Esophageal arteries, the Pericardial arteries, the Phrenic arteries, the Celiac trunk, the Suprarenal arteries, the Renal arteries, the Mesenteric arteries, the Gonadal arteries, and the Lumbar arteries.
//PRESSURE OR DISTANCE//
68. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member is configured to be placed at a distance from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel.
69. The implantable system according to aspect 68, wherein the adjustable vessel member is configured to be placed at a distance in the interval 0,5mm - 3mm from the blood vessel, such that the inner surface does not engage the outer surface of the blood vessel.
70. The implantable system according to any one of aspects 1 - 67, wherein the inner surface of the adjustable vessel member is configured to engage the outer surface of the blood vessel.
71. The implantable system according to any one of the preceding aspects, wherein the inner surface of the adjustable vessel member comprises at least one inflatable portion at least partially facing the outer surface of the blood vessel.
72. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member is adapted to exert a pressure in the range between systolic and diastolic blood pressure of the patient.
73. The implantable system according to any one of aspects 71 - 72, wherein the operation device comprises at least one valve for controlling the flow of a fluid to and from the inflatable portion.
74. The implantable system according to any one of aspects 17 - 73, wherein the first segment comprises a first inflatable portion and the second segment comprises a second inflatable portion.
75. The implantable system according to aspect 74, wherein the operation device comprises: a first valve for controlling the flow of a fluid to and from the first inflatable portion, and a second valve for controlling the flow of a fluid to and from the second inflatable portion.
76. The implantable system according to any one of aspects 74 and 75, further comprising a conduit for creating a fluid connection between the first and second inflatable portion.
77. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises an elastic material.
78. The implantable system according to aspect 77, wherein the adjustable vessel member is adapted to exert a mechanical pressure by the elastic properties of the elastic material.
79. The implantable system according to any one of aspects 17 - 78, wherein the first segment is configured to exert a first pressure on the blood vessel and the second segment is configured to exert a second pressure on the blood vessel, and wherein the first and second pressures are individually adjustable.
80. The implantable system according to any one of the preceding aspects, further comprising an implantable controller for controlling the operation device.
81. The implantable system according to aspect 80, wherein the implantable controller is configured to control the operation device to adjust the pressure exerted on the blood vessel by the adjustable vessel member.
82. The implantable system according to any one of the preceding aspects, wherein the operation device comprises a hydraulic operation device, and wherein the implantable system further comprises an expandable hydraulic reservoir.
83. The implantable system according to aspect 82, wherein the expandable hydraulic reservoir is in fluid connection with the inflatable portion of the adjustable vessel member, and wherein the pressure exerted on the blood vessel from the inflatable portion is configured to be adjusted by the operation device creating a flow of fluid from the expandable hydraulic reservoir to the inflatable portion.
84. The implantable system according to aspect 83, wherein the operation device further comprises a pump for pumping fluid from the expandable hydraulic reservoir to the inflatable portion for adjusting the pressure exerted on the blood vessel from the inflatable member, and wherein the pump is connected to the implantable controller such that the implantable controller can control the operation of the pump.
85. The implantable system according to any one of the preceding aspects, wherein the operation device comprises a mechanical operation device configured to adjust the pressure exerted by the adjustable vessel member on the blood vessel.
86. The implantable system according to aspect 85, wherein the mechanical operation device comprises an electrical motor configured to adjust the pressure exerted by the vessel member on the blood vessel.
87. The implantable system according to any one of preceding aspects, wherein the at least one adjustable vessel member comprises an enclosing cross-sectional area perpendicular to the direction of the length extension (LE) of the blood vessel, the enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel.
88. The implantable system according to aspect 87, wherein the mechanical operation device is adapted to adjust the pressure exerted by the adjustable vessel member on the blood vessel by altering the size of the enclosing cross-section area.
89. The implantable system according to aspect 87, wherein the hydraulic operation device is adapted to adjust the pressure exerted by the adjustable vessel member on the blood vessel by altering the size of the enclosing cross-section area.
//SENSOR// 90. The implantable system according to any one of aspects 80 - 89, further comprising at least one sensor connected to the implantable controller.
91. The implantable system according to aspect 90, wherein the sensor is a sensor configured to sense a physical parameter of the implantable system.
92. The implantable system according to aspect 91, wherein the sensor is configured to sense a physical parameter of the implantable system comprising at least one of: a parameter related to strain in the implantable system, a volume, a pressure, a temperature of the implantable system, a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
93. The implantable system according to aspect 92, wherein the sensor configured to sense a parameter related to strain in the implantable system is configured to sense a strain in the adjustable vessel member connected to the expansion of the aneurysm.
94. The implantable system according to aspect 93, wherein the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the adjustable vessel member.
95. The implantable system according to aspect 92, wherein the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the adjustable vessel member.
96. The implantable system according to any one of aspects 90 - 95, wherein the inner surface of the adjustable vessel member comprises the sensor or is connected to the sensor.
97. The implantable system according to any one of aspects 90 - 96, wherein the sensor is connected to the expandable hydraulic reservoir, and wherein the sensor is configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
98. The implantable system according to any one of aspects 90 - 97, wherein the sensor is connected to the inflatable portion, and wherein the sensor is configured to sense an expansion of the aneurysm by sensing at least one of a pressure change and a volume change in the inflatable portion.
99. The implantable system according to aspect 90, wherein the sensor is configured to sense at least one physiological parameter of the patient.
100. The implantable system according to aspect 99, wherein the sensor is a sensor configured to sense at least one of: an expansion of the aneurysm, a size of the aneurysm a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
101. The implantable system according to aspects 100, wherein the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
102. The implantable system according to any one of aspects 87 - 101, wherein the implantable controller is configured to transmit information based on sensor input to a source external to the body of the patient.
103. The implantable system according to aspect 102, wherein the controller is configured to transmit the information based on sensor input to a source external to the body of the patient, wirelessly.
//ATTACHEMENT//
104. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises an attachment device (30) for attaching the adjustable vessel member to a portion of the body of the patient.
105. The implantable system according to any one of aspects 17 - 104, wherein the vessel member comprises a first attachment device (3 OX) for attaching the first segment (SI) to a portion of the body of the patient and a second attachment device (3 OX) for attaching the second segment (S2) to a portion of the body of the patient.
106. The implantable system according to any one of aspects 104 - 105, wherein the attachment device is configured to attach the vessel member to a portion of the body of the patient comprising bone.
//REMOTE UNIT//
107. The implantable system according to any one of the preceding aspects, further comprising a remote unit connected to the adjustable vessel member, wherein a major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the adjustable vessel member. 108. The implantable system according to aspect 107, wherein the remote unit comprises at least a portion of the operation device.
109. The implantable system according to any one of aspects 107 - 108, further comprising a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the adjustable vessel member, for operating the adjustable vessel member.
110. The implantable system according to any one of the preceding aspects, wherein the adjustable vessel member comprises at least part of the operation device.
111. The implantable system according to aspect 110, wherein the part of the operation device comprised in the adjustable vessel member comprises a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel.
112. The implantable system according to aspect 111, wherein the receiving portion is configured to receive a linear mechanical force.
113. The implantable system according to aspect 111, wherein the receiving portion is configured to receive a rotating mechanical force, and wherein the transmission is configured to transform the received rotating mechanical force into a liner mechanical force.
114. The implantable system according to any one of aspect 111 - 113, wherein the transmission comprises a gear system configured to reduce the velocity and increase the force of the received mechanical force.
115. The implantable system according to any one of aspects 108 - 114, wherein the portion of the operation device placed in the remote unit comprises an electrical motor.
116. The implantable system according to aspect 115, wherein the portion of the operation device placed in the remote unit further comprises a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
117. The implantable system according to any one of aspects 110 - 116, wherein the portion of the operation device placed in the adjustable vessel member comprises a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel.
118. The implantable system according to aspect 117, wherein the transmission comprises at least one hydraulic cylinder.
119. The implantable system according to any one of aspects 110 - 118, wherein the portion of the operation device placed in the adjustable vessel member comprises a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
120. The implantable system according to any one of aspects 108 - 119, wherein the portion of the operation device placed in the remote unit comprises at least one operable valve for controlling a flow of hydraulic fluid. 121. The implantable system according to any one of aspects 119 and 120, wherein the operable valve is configured to control the flow of hydraulic fluid between at least one of: the expandable hydraulic reservoir and the first inflatable portion, the expandable hydraulic reservoir and the second inflatable portion, and the first inflatable member and the second inflatable portion.
122. The implantable system according to any one of aspects 108 - 119, wherein the portion of the operation device placed in the remote unit comprises at least one hydraulic pump.
123. The implantable system according to any one of aspects 107 - 122, wherein the remote unit comprises a hydraulic reservoir for holding a hydraulic fluid.
124. The implantable system according to any one of aspects 107 - 123, wherein the remote unit comprises an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
125. The implantable system according to any one of aspects 107 - 124, wherein the remote unit further comprises an energy storage unit for directly or indirectly energizing the implantable system.
126. The implantable system according to any one of aspects 107 - 125, wherein the remote unit further comprises the implantable controller.
127. The implantable system according to aspect 126, wherein the implantable controller comprises a wireless transceiver for communicating wirelessly with a source external to the body of the patient.
128. The implantable system according to any one of aspects 107 - 127, wherein the implantable system further comprises at least one lead for transferring electrical energy and/or information from the remote unit to the adjustable vessel member.
129. The implantable system according to any one of aspects 107 - 128, wherein the implantable system further comprises a housing configured to enclose the remote unit.
130. The implantable system according to aspect 129, wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
131. The implantable system according to aspect 130, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
132. The implantable system according to any one of aspects 117 - 131, wherein the remote unit comprises: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion, wherein: the first, second and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
133. The implantable system according to aspect 132, wherein at least one of: the first portion is detachably connected to the connecting portion, and the second portion is detachably connected to the connecting portion.
134. An implantable system according to aspect 1-133, wherein the at least one adjustable vessel member is configured for at least partially enclosing a portion of a curved blood vessel of the patient.
135. A method of implanting an implantable system for handling an aneurysm in a blood vessel of a patient, the method comprising: making an incision in the body of the patient for accessing a vessel having an aneurysm, dissecting a portion of the vessel, and placing at least one vessel member according to any one of aspects 1 - 134 in connection with or adjacent to the blood vessel.
136. The method according to aspect 135, further comprising the step of connecting two or more parts for forming the vessel member.
137. The method according to any one of aspects 135 and 136, further comprising the step of placing at least one branching blood vessel in an opening or recess in the vessel member.
138. The method according to any one of aspects 135 - 137, further comprising placing a remote unit connected to the vessel member at a distance exceeding 80mm from a major portion of the vessel member.
139. The method according to any one of aspects 135 - 138, further comprising attaching the adjustable vessel member to a portion of the body of the patient.
140. The method according to any one of aspects 135 - 139, wherein the step of placing at least one vessel member according to any one of aspects 1 - 134 in connection with or adjacent to the blood vessel, comprises placing at least one vessel member according to any one of aspects 1 - 134 in connection with or adjacent to the aortic arch.
Aspect 427 - Distance 1. An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially contacting a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. The implantable system according to aspect 1, wherein the inner surface of the vessel member is configured to be placed at a distance from the outer surface of the blood vessel in the range 0,5mm - 10mm.
3. The implantable system according to aspect 2, wherein the inner surface of the vessel member is configured to be placed at a distance from the outer surface of the blood vessel in the range 1mm - 5mm.
4. The implantable system according to any one of the preceding aspects, wherein the inner surface of the vessel member comprises a resilient material.
5. The implantable system according to aspect 4, wherein the inner surface of the vessel member comprises a polymer material.
6. The implantable system according to aspect 5, wherein the inner surface of the vessel member comprises a material selected from a list comprising silicone-based materials and polyurethane-based materials.
7. The implantable system according to any one of the preceding aspects, wherein the vessel member is an adjustable vessel member, for adjusting at least one of: the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and a pressure exerted by the vessel member on the blood vessel.
8. The implantable system according to aspect 7, further comprising an implantable operation device for postoperatively and non-invasively operating the adjustable vessel member, for adjusting at least one of: the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and the pressure exerted by the vessel member on the blood vessel. 9. The implantable system according to aspect 8, wherein the implantable operation device is configured to adjust the adjustable vessel member such that the adjustable vessel member exerts a pressure on the outer surface of the blood vessel in the range between a systolic and a diastolic blood pressure of the patient.
10. The implantable system according to any one of aspects 7 - 9, wherein the inner surface of the vessel member comprises at least one inflatable portion at least partially facing the outer surface of the blood vessel.
11. The implantable system according to aspect 10, wherein the operation device comprises a hydraulic operation device for hydraulically inflating the at least one inflatable portion at least partially facing the outer surface of the blood vessel.
12. The implantable system according to aspect 11, wherein the hydraulic operation device comprises at least one hydraulic pump for pumping a hydraulic fluid to and from the inflatable portion.
13. The implantable system according to any one of aspects 11 and 12, wherein the hydraulic operation device comprises at least one valve for controlling the flow of a fluid to and from the inflatable portion.
14. The implantable system according to any one of aspects 8 and 9, wherein the operation device comprises a mechanical operation device for mechanically adjusting at least one of: the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and a pressure exerted by the vessel member on the blood vessel.
15. The implantable system according to any one of aspects 8 and 9, wherein the operation device comprises an electrical operation device for electrically adjusting at least one of: the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and a pressure exerted by the vessel member on the blood vessel.
16. The implantable system according to any one of aspects 7 - 15, wherein the adjustable vessel member comprises an enclosing cross-sectional area perpendicular to the direction of the length extension of the blood vessel, the enclosing cross-sectional area being configured for at least partially enclosing a portion of the blood vessel, and wherein the adjustable vessel member is configured to adjusting at least one of the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and a pressure exerted by the vessel member on the blood vessel, by the adjustable vessel member altering the size of the enclosing cross-section area.
17. The implantable system according to aspect 16, wherein the adjustable vessel member comprises a cuff configured to encircle a portion of the blood vessel, and wherein the inner circumference of the cuff forms the outer circumference of the enclosing cross-sectional area, and wherein the adjustable vessel member is configured to alter the size of the enclosing cross-section area by altering the inner circumference of the cuff.
18. The implantable system according to any one of aspects 7 - 17, wherein the adjustable vessel member comprises: a first portion configured to be positioned such that an inner surface of the first portion faces a first portion of the outside of the blood vessel, and a second portion configured to be positioned such that an inner surface of the second portion faces a second portion of the outside of the blood vessel.
19. The implantable system according to aspect 18, wherein the first and second portions are individually adjustable.
20. The implantable system according to any one of aspects 8 - 19, further comprising an implantable controller for controlling the operation device.
21. The implantable system according to aspect 20, wherein the implantable controller is configured to control the operation device to adjust at least one of: the distance between the inner surface of the vessel member and the outer surface of the blood vessel, and the pressure exerted by the vessel member on the blood vessel.
22. The implantable system according to any one of the preceding aspects, further comprising at least one sensor configured to sense at least one of: connection between the inner surface of the vessel member and the outer surface of the blood vessel, and pressure or force exerted by the blood vessel on the inner surface of the vessel member.
23. The implantable system according to any one of the preceding aspects, further comprising at least one sensor configured to sense a parameter related to the expansion of the aneurysm.
24. The implantable system according to aspect 23, wherein the sensor configured to sense an expansion of the aneurysm is a sensor configured to sense at least one of: a diameter or cross-sectional distance of a blood vessel, a wall thickness of the blood vessel, a flow rate through a blood vessel, or an optical parameter related to the state of the blood vessel.
25. The implantable system according to any one of aspects 22 - 24, wherein the sensor is configured to sense at least one of: a pressure in an inflatable portion of the vessel member, a volume in an inflatable portion of the vessel member, a strain in the vessel member, an electrical connection or change in resistance, an optical change, and a temperature change.
26. The implantable system according to any one of aspects 22 - 25, wherein the sensor is connected to the implantable controller, and wherein the implantable controller is configured to at least one of: control the adjustable vessel member, transmit signals to a device external to the body of the patient, and create a log entry, on the basis of a received input from the sensor.
27. The implantable system according to aspect 26, wherein the controller is configured to control the adjustable vessel member to increase the pressure exerted on the blood vessel by the adjustable vessel member in response to received input from the sensor.
26. The implantable system according to any one of the preceding aspects, further comprising at least one sensor configured to sense at least one of: a parameter related to the power consumption of the implantable system, a parameter related to a status of the energy storage unit, and a parameter related to a wireless transfer of energy from a source external to the body of the patient.
27. The implantable system according to any one of aspects 24 - 26, wherein the sensor configured to sense a volume is configured to sense a volume related to a volume of fluid in at least one inflatable portion of the vessel member.
28. The implantable system according to any one of aspects 24 - 26, wherein the sensor configured to sense a pressure is configured to sense a pressure in at least one inflatable portion of the vessel member.
29. The implantable system according to any one of aspects 22 - 28, wherein the inner surface of the vessel member comprises the sensor or is connected to the sensor.
30. The implantable system according to any one of aspects 22 - 29, wherein the sensor is connected to a hydraulic reservoir connected to the inflatable portion, and wherein the sensor is configured to sense the pressure or volume in the inflatable portion by sensing the pressure or volume in the expandable hydraulic reservoir.
31. The implantable system according to any one of the preceding aspects, further comprising at least one sensor configured to sense at least one physiological parameter of the patient.
32. The implantable system according to aspect 31, wherein the sensor is a sensor configured to sense at least one of: an expansion of the aneurysm, a local temperature, a systemic temperature, blood saturation, blood oxygenation, blood pressure, or a parameter related to an ischemia marker.
//ATTACHEMENT//
33. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises an attachment device for attaching the vessel member to a portion of the body of the patient.
34. The implantable system according to aspect 33, wherein the attachment device is configured to attach the vessel member to a portion of the body of the patient comprising bone.
35. The implantable system according to any one of the preceding aspects, wherein the vessel member can be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
36. The implantable system according to aspects 35, wherein the adjustable vessel member comprises at least one pivot joint for enabling the adjustable vessel member to be at least partially opened for being introduced over the blood vessel for at least partially enclosing the blood vessel.
37. The implantable system according to any one of the preceding aspects, wherein the inner surface comprises at least one curvature configured to be placed in the direction of the length extension of the blood vessel, such that the inner surface can follow a curvature of the blood vessel.
38. The implantable system according to any one of the preceding aspects, wherein the inner surface of the vessel member comprises at least a first and a second portion and wherein the first and second portions are angled relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
39. The implantable system according to any one of the preceding aspects, wherein the inner surface of the vessel member comprises at least a first and a second portion and wherein the first and second portions are displaced relative to each other, such that the vessel member can follow a curvature of the blood vessel in the direction of the length extension of the blood vessel.
40. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises a first part and an a second part, and wherein the first and second parts are adapted to be connected to each other to form at least a portion of the vessel member.
41. The implantable system according to aspect 40, wherein the first and second parts are adapted to be assembled such that the joint between the first and second parts is more parallel than perpendicular to the direction of the length extension of the blood vessel.
42. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
43. The implantable system according to aspect 42, wherein the at least one opening comprises at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel.
44. The implantable system according to aspect 43, wherein the through-hole has a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
45. The implantable system according to any one of aspects 42 - 44, wherein the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm.
46. The implantable system according to aspect 42, wherein the recess comprises at least one furrow adapted to accommodate at least one branching blood vessel.
//REMOTE UNIT//
47. The implantable system according to any one of the preceding aspects, further comprising a remote unit connected to the vessel member, wherein a major portion of the remote unit is configured to be placed at a distance exceeding 80mm from a major portion of the vessel member.
48. The implantable system according to aspect 47, wherein the remote unit comprises at least a portion of the operation device.
49. The implantable system according to any one of aspects 47 - 48, further comprising a force transferring element configured to transfer force hydraulically or mechanically from the remote unit to the vessel member, for operating the vessel member.
50. The implantable system according to any one of the preceding aspects, wherein the vessel member comprises at least part of the operation device.
51. The implantable system according to aspect 50, wherein the part of the operation device comprised in the vessel member comprises a receiving portion configured to receive mechanical force, and a transmission for transforming the received mechanical force into a force for exerting a pressure on the blood vessel.
52. The implantable system according to aspect 51, wherein the receiving portion is configured to receive a linear mechanical force.
53. The implantable system according to aspect 51, wherein the receiving portion is configured to receive a rotating mechanical force, and wherein the transmission is configured to transform the received rotating mechanical force into a liner mechanical force. 54. The implantable system according to any one of aspect 51 - 53, wherein the transmission comprises a gear system configured to reduce the velocity and increase the force of the received mechanical force.
55. The implantable system according to any one of aspects 48 - 54, wherein the portion of the operation device placed in the remote unit comprises an electrical motor.
56. The implantable system according to aspect 55, wherein the portion of the operation device placed in the remote unit further comprises a gear system configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
57. The implantable system according to any one of aspects 50 - 56, wherein the portion of the operation device placed in the vessel member comprises a receiving portion configured to receive hydraulic force, and a transmission for transforming the received hydraulic force into a force for exerting a pressure on the blood vessel.
58. The implantable system according to aspect 57, wherein the transmission comprises at least one hydraulic cylinder.
59. The implantable system according to any one of aspects 50 - 58, wherein the portion of the operation device placed in the vessel member comprises a receiving portion configured to receive hydraulic force conducted by a flow of hydraulic fluid, and at least one operable valve for controlling the flow of hydraulic fluid.
60. The implantable system according to any one of aspects 48 - 59, wherein the portion of the operation device placed in the remote unit comprises at least one operable valve for controlling a flow of hydraulic fluid.
61. The implantable system according to any one of aspects 48 - 60, wherein the portion of the operation device placed in the remote unit comprises at least one hydraulic pump.
62. The implantable system according to any one of aspects 48 - 61, wherein the remote unit comprises a hydraulic reservoir for holding a hydraulic fluid.
63. The implantable system according to any one of aspects 47 - 62, wherein the remote unit comprises an injection port for at least one of injecting and removing hydraulic fluid from the implantable system.
64. The implantable system according to any one of aspects 47 - 63, wherein the remote unit further comprises an energy storage unit for directly or indirectly energizing the implantable system.
65. The implantable system according to any one of aspects 47 - 64, wherein the remote unit further comprises the implantable controller.
66. The implantable system according to aspect 65, wherein the implantable controller comprises a wireless transceiver for communicating wirelessly with a source external to the body of the patient. 67. The implantable system according to any one of aspects 47 - 66, wherein the implantable system further comprises at least one lead for transferring electrical energy and/or information from the remote unit to the vessel member.
68. The implantable system according to any one of aspects 47 - 67, wherein the implantable system further comprises a housing configured to enclose the remote unit.
69. The implantable system according to aspect 68, wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
70. The implantable system according to aspect 69, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
71. The implantable system according to any one of aspects 47 - 70, wherein the remote unit comprises: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second portion having a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion, wherein: the first, second and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.
72. The implantable system according to aspect 71, wherein at least one of: the first portion is detachably connected to the connecting portion, and the second portion is detachably connected to the connecting portion.
73. An implantable system according to aspect 1-72, wherein the at least one adjustable vessel member is configured for at least partially enclosing a portion of the blood vessel of the patient.
74. A method of implanting an implantable system for handling an aneurysm in a blood vessel of a patient, the method comprising: making an incision in the body of the patient for accessing a vessel having an aneurysm, dissecting a portion of the vessel, and placing at least one vessel member according to any one of aspects 1 - 73 in connection with or adjacent to the blood vessel. 75. The method according to aspect 74, further comprising the step of connecting two or more parts for forming the vessel member.
76. The method according to any one of aspects 74 and 75, further comprising the step of placing at least one branching blood vessel in an opening or recess in the vessel member.
77. The method according to any one of aspects 74 - 76, further comprising placing a remote unit connected to the vessel member at a distance exceeding 80mm from a major portion of the vessel member.
78. The method according to any one of aspects 74 - 77, further comprising attaching the adjustable vessel member to a portion of the body of the patient.
79. The method according to any one of aspects 74 - 78, wherein the step of placing at least one vessel member according to any one of aspects 1 - 73 in connection with or adjacent to the blood vessel, comprises placing at least one vessel member according to any one of aspects 1 - 73 in connection with or adjacent to the aortic arch.
79. A method of implanting an implantable constriction device, the method comprises the steps of: making an incision in the body of the patient, for accessing the luminary organ, dissecting a portion of the luminary organ, inserting an implantable constriction device into the body of the patient, placing the implantable constriction device in connection with the luminary organ, such that the implantable constriction device can constrict the luminary organ to restrict the flow of fluid therethrough.
Aspect 307B Communication remote control
1. A system for controlling a medical implant implanted in a patient, comprising: an internal control unit adapted to be arranged within the patient’s body and communicatively coupled to the medical implant, the internal control unit comprising: a processing unit having a sleep mode and an active mode, and a sensor configured to detect a wake signal; and an external control unit adapted to be arranged outside of the patient’s body, the external control unit comprising: a signal provider configured to provide the wake signal; wherein the internal control unit is further configured to set the processing unit to the active mode in response to the sensor detecting the wake signal, and wherein the medical implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system for controlling a medical implant implanted in a patient, comprising: an internal control unit adapted to be arranged within the patient’s body and communicatively coupled to the medical implant, the internal control unit comprising: a processing unit having a sleep mode and an active mode, and a sensor configured to detect a wake signal; and an external control unit adapted to be arranged outside of the patient’s body, the external control unit comprising: a signal provider configured to provide the wake signal; wherein the internal control unit is further configured to set the processing unit to the active mode in response to the sensor detecting the wake signal, and wherein the medical implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system for controlling a medical implant implanted in a patient, comprising: an internal control unit adapted to be arranged within the patient’s body and communicatively coupled to the medical implant, the internal control unit comprising: a processing unit having a sleep mode and an active mode, and a sensor configured to detect a wake signal; and an external control unit adapted to be arranged outside of the patient’s body, the external control unit comprising: a signal provider configured to provide the wake signal; wherein the internal control unit is further configured to set the processing unit to the active mode in response to the sensor detecting the wake signal, and wherein the medical implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system for controlling a medical implant implanted in a patient, comprising: an internal control unit adapted to be arranged within the patient’s body and communicatively coupled to the medical implant, the internal control unit comprising: a processing unit having a sleep mode and an active mode, and a sensor configured to detect a wake signal; and an external control unit adapted to be arranged outside of the patient’s body, the external control unit comprising: a signal provider configured to provide the wake signal; wherein the internal control unit is further configured to set the processing unit to the active mode in response to the sensor detecting the wake signal, and wherein the medical implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any one of the preceding embodiments, wherein: the signal provider is an acoustic source configured to provide an acoustic signal as the wake signal.
6. The system according to any one of the preceding embodiments, wherein: the signal provider is a magnetic source configured to provide a magnetic signal as the wake signal.
7. The system according to any one of the preceding embodiments, wherein: the sensor is configured to detect the received signal strength of a signal; and the internal control unit is further configured to set the processing unit to the active mode in response to the sensor detecting a signal exceeding a threshold signal strength.
8. The system according to any one the preceding embodiments, wherein: the sensor is configured to provide a control signal indicative of a wake signal, the internal control unit is configured to set the processing unit to the active mode in response to the control signal, and the internal control unit is configured to control a supply of energy to the processing unit in response to the control signal.
9. The system according to any one of the preceding embodiments, wherein: the wake signal comprises a predetermined signal pattern; and the internal control unit is further configured to set the processing unit to the active mode in response to the sensor detecting the predetermined signal pattern.
10. The system according to any one of the preceding embodiments, wherein: the magnetic source comprises a first coil.
11. The system according to embodiment 10, wherein: the magnetic source further comprises a second coil arranged perpendicular to the first coil, whereby to collectively provide a substantially even magnetic field.
12. The system according to embodiment 10 or embodiment 11, wherein: the first coil and/or the second coil is configured to provide a signal as a magnetic field with a frequency of 9 to 315 kilohertz, kHz.
13. The system according to embodiment 12, wherein: the frequency is less than or equal to 125 kHz, preferably less than 58 kHz.
14. The system according to embodiment 13, wherein: the frequency is less than 50 kHz, preferably less than 20 kHz, more preferably less than 10 kHz.
15. The system according to any of embodiments 6 to 14, wherein: the magnetic source comprises a magnet.
16. The system according to embodiment 15, wherein: the magnet is a permanent magnet.
17. The system according to any of embodiments 6 to 16, wherein: the magnetic source has an off state in which the magnetic source does provides a magnetic field and an on state in which the magnetic source provides a magnetic field.
18. The system according to embodiment 17 wherein the magnetic source further comprises a shielding means for preventing, when the magnetic source is in the off state, the magnetic source from providing a magnetic field.
19. The system according to any of embodiments 6 to 18, wherein the sensor comprises a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor or a magneto-resistive sensor.
20. The system according to any of embodiments 16 to 19, wherein the sensor comprises a third coil having an iron core.
21. The system according to any one of the preceding embodiments, wherein: the internal control unit comprises a first communication unit for receiving and/or transmitting data from and/or to the external control unit; and the external control unit comprises a second communication unit for transmitting and/or receiving data to and/or from the internal control unit.
22. The system according to embodiment 21, wherein the sensor is comprised in the first communication unit.
23. The system according to embodiment 21 or embodiment 22, further comprising: a frequency detector communicatively coupled to the internal control unit and configured to detect a frequency for data communication between the first communication unit and the second communication unit.
Aspect 308B Energy Power-supply capacitor
1. An apparatus for powering an implant for a human patient, comprising: an implantable energy source for providing energy to the implant, an energy provider connected to the implantable energy source and connected to an energy consuming part of the implant, the energy provider being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider is configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power during startup of the energy consuming part, and wherein the medical implant comprises an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. An apparatus for powering an implant for a human patient, comprising: an implantable energy source for providing energy to the implant, an energy provider connected to the implantable energy source and connected to an energy consuming part of the implant, the energy provider being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider is configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power during startup of the energy consuming part, and wherein the medical implant comprises an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. An apparatus for powering an implant for a human patient, comprising: an implantable energy source for providing energy to the implant, an energy provider connected to the implantable energy source and connected to an energy consuming part of the implant, the energy provider being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider is configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power during startup of the energy consuming part, and wherein the medical implant comprises an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta. 4. An apparatus for powering an implant for a human patient, comprising: an implantable energy source for providing energy to the implant, an energy provider connected to the implantable energy source and connected to an energy consuming part of the implant, the energy provider being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider is configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power during startup of the energy consuming part, and wherein the medical implant comprises an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
5. The apparatus according to any preceding embodiment, wherein the discharging from the implantable energy source during startup of the energy consuming part is slower than the energy needed for startup of the energy consuming part.
6. The apparatus according to any preceding embodiment, wherein a maximum energy consumption of the energy consuming part is higher than the maximum energy capable of being delivered by the implantable energy source without causing damage to the implantable energy source, and wherein the energy provider is adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy source. 7. The apparatus according to any preceding embodiment, wherein the implantable energy source is a re-chargeable battery.
8. The apparatus according to any preceding embodiment, wherein the implantable energy source is a solid-state battery.
9. The apparatus according to embodiment 8, wherein the battery is a trionychoid battery.
10. The apparatus according to any preceding embodiment, wherein the implantable energy source is connected to the energy consuming part and configured to power the energy consuming part after it has been started using the energy provider.
11. The apparatus according any preceding embodiment, wherein the energy provider is a capacitor.
12. The apparatus according to any preceding embodiment, wherein the energy provider is a start capacitor.
13. The apparatus according to any preceding embodiment, wherein the energy provider is a run capacitor.
14. The apparatus according to any preceding embodiment, wherein the energy provider is a dual run capacitor.
15. The apparatus according to any preceding embodiment, further comprising a second energy provider configured to be charged by the implantable energy source and to provide the energy consuming part with electrical power.
16. The apparatus according to any preceding embodiment, wherein the energy provider is a supercapacitor.
17. The apparatus according to any preceding embodiment, wherein the energy consuming part is a motor for operating a device or function of the implant.
18. The apparatus according to any preceding embodiment, wherein the energy consuming part is at least one of:
• a device for providing electrical stimulation to a tissue portion of the body of the patient,
• a CPU for encrypting information
• a transmitting and/or receiving unit for communication with an external unit
• a measurement unit or a sensor
• a data collection unit
• a solenoid
• a piezo-electrical element
• a memory metal unit. 19. The apparatus according to any preceding embodiment, wherein the energy consuming part is motor for powering a hydraulic pump.
20. The apparatus according to any preceding embodiment, wherein the energy consuming part is a feedback unit.
21. The apparatus according to embodiment 20, wherein the feedback unit is a vibrator.
22. The apparatus according to any preceding embodiment, wherein the energy consuming part is configured to operate a valve comprised in the implant.
23. The apparatus according to any preceding embodiment, wherein the energy consuming part is a control unit for controlling at least a part of the implant.
Aspect 309B eHealth broadcasting data
1. An implant comprising: at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implant to obtain a sensed parameter, and a communication unit configured to broadcast data; wherein the sensor is configured to periodically sense the parameter and wherein the communication unit is configured to broadcast the data relating to the sensed parameter in response to at least one of
• the sensed parameter being above a predetermined threshold,
• the sensed parameter being below a predetermined threshold,
• the sensed parameter being outside of a predetermined range,
• a predetermined point in time,
• an expiry of a time period,
• a predetermined event, or
• a use of the implant, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. An implant comprising: at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implant to obtain a sensed parameter, and a communication unit configured to broadcast data; wherein the sensor is configured to periodically sense the parameter and wherein the communication unit is configured to broadcast the data relating to the sensed parameter in response to at least one of
• the sensed parameter being above a predetermined threshold,
• the sensed parameter being below a predetermined threshold,
• the sensed parameter being outside of a predetermined range,
• a predetermined point in time,
• an expiry of a time period,
• a predetermined event, or
• a use of the implant, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. An implant comprising: at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implant to obtain a sensed parameter, and a communication unit configured to broadcast data; wherein the sensor is configured to periodically sense the parameter and wherein the communication unit is configured to broadcast the data relating to the sensed parameter in response to at least one of the sensed parameter being above a predetermined threshold, • the sensed parameter being below a predetermined threshold,
• the sensed parameter being outside of a predetermined range,
• a predetermined point in time,
• an expiry of a time period,
• a predetermined event, or
• a use of the implant, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. An implant comprising: at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implant to obtain a sensed parameter, and a communication unit configured to broadcast data; wherein the sensor is configured to periodically sense the parameter and wherein the communication unit is configured to broadcast the data relating to the sensed parameter in response to at least one of
• the sensed parameter being above a predetermined threshold,
• the sensed parameter being below a predetermined threshold,
• the sensed parameter being outside of a predetermined range,
• a predetermined point in time,
• an expiry of a time period, • a predetermined event, or
• a use of the implant, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The implant according to any preceding embodiment, wherein the communication unit is configured to broadcast the information using a short to mid-range transmitting protocol.
6. The implant according to any preceding embodiment, wherein the information is broadcasted using at least one of:
Radio Frequency type protocol
RFID type protocol
WLAN type protocol
Bluetooth type protocol
BLE type protocol
NFC type protocol
3G/4G/5G type protocol
GSM type protocol.
7. The implant according to any preceding embodiment, wherein the implant further comprises a control unit connected to the sensor and to the communication unit, wherein the control unit is configured to anonymize the information.
8. The implant according to any preceding embodiment, wherein the implant further comprises a control unit connected to the sensor and to the communication unit, wherein the control unit is configured to encrypt the information. 9. The implant according to any preceding embodiment, wherein the communication unit further is configured to broadcast the information periodically.
10. The implant according to any preceding embodiment, further comprising a control unit configured to cause the communication unit to broadcast the information in response to a second parameter being above a predetermined threshold.
11. The implant according to any of the preceding embodiments, wherein the sensed parameter is at least one of a temperature, a pulse, a glucose level, an activity of an organ, or an acceleration.
12. The implant according to any of the preceding embodiments, further comprising an implantable energy source and an energy source indicator, wherein the energy source indicator is configured to indicate a functional status of the implantable energy source.
13. The implant according to embodiment 12, wherein the functional status indicates at least one of charge level and temperature of the implantable energy source.
14. The implant according to any preceding embodiment, wherein the functional parameter is a parameter relating to the internal control unit.
Aspect 310B eHealth double encryption
1. A system comprising: an implant comprising: a communication unit configured to transmit data from the body of the patient to an external device, and an encryption unit for encrypting the data to be transmitted, and an external device configured to receive the data transmitted by the communication unit, encrypt the received data using a first key and transmit the encrypted received data to a third device, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an atachment device for ataching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system comprising: an implant comprising: a communication unit configured to transmit data from the body of the patient to an external device, and an encryption unit for encrypting the data to be transmited, and an external device configured to receive the data transmited by the communication unit, encrypt the received data using a first key and transmit the encrypted received data to a third device, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system comprising: an implant comprising: a communication unit configured to transmit data from the body of the patient to an external device, and an encryption unit for encrypting the data to be transmited, and an external device configured to receive the data transmited by the communication unit, encrypt the received data using a first key and transmit the encrypted received data to a third device, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S 1 ,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system comprising: an implant comprising: a communication unit configured to transmit data from the body of the patient to an external device, and an encryption unit for encrypting the data to be transmitted, and an external device configured to receive the data transmitted by the communication unit, encrypt the received data using a first key and transmit the encrypted received data to a third device, wherein the implant comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any of the preceding embodiments, wherein the encryption unit is configured to encrypt the data to be transmitted using a second key. 6. The system according to any of the preceding embodiments, wherein the first key or the second key is implant specific information, a secret key associated with the external device, an identifier of the implant or an identifier of the communication unit.
7. The system according to any of the preceding embodiments, wherein the second key is a key transmitted by the external device to the internal device.
8. The system according to any of the preceding embodiments, wherein the second key is a combined key comprising a third key received by the implant form the external device.
9. The system according to any preceding embodiment, wherein the first key is a combined key comprising a fourth key, wherein the fourth key is received by the external device from a verification unit connected to or comprised in the external device.
10. The system according to any preceding embodiment, wherein the verification unit is configured to receive authentication input from a user, for authenticating the communication between the implant and the external device.
11. The system according to embodiment 10, wherein the authentication input is a code.
12. The system according to embodiment 10, wherein the authentication input is based on a biometric technique selected from the list of: a fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison.
13. The system according to embodiment 12, wherein the verification unit is configured to receive a fingerprint from a fingerprint reader.
14. The system according to any preceding embodiment, wherein the information is broadcasted using a short to mid-range transmitting protocol.
15. The system according to any preceding embodiment, wherein the information is transmitted using at least one of:
• Radio Frequency type protocol
• RFID type protocol
• WLAN type protocol
• Bluetooth type protocol
• BLE type protocol
• NFC type protocol
• 3G/4G/5G type protocol
• GSM type protocol.
• Bluetooth 5
16. The system according to any preceding embodiment, wherein the internal device comprises a first conductive member and the external device comprises a second conductive member, wherein the first and the second conductive members are configured to transmit the data using the body as a conductor. 17. The system according to any preceding embodiment, wherein the communication unit is configured to encrypt the data before transmitting the data.
18. The system according to embodiment 9 wherein the external device is configured to decrypt the received data and encrypt it before transmitting the data to the third device.
19. The system according to any preceding embodiment, wherein the external device is configured to transmit a request for data to the communication unit, and the communication unit is configured to in response to a request for data transmit the data to the external device.
20. The system according to any preceding embodiment, wherein the communication unit further is configured to broadcast the information periodically.
21. The system according to any preceding embodiment, further comprising an internal control unit configured to cause the communication unit to broadcast the information in response to a second parameter being above a predetermined threshold.
Aspect 31 IB Communication remote control
1. A system for communication instructions, the system comprising: an implant adapted to be implanted in a patient, the implant comprising an active unit, an internal communication unit and an internal controller, an external device comprising an external communication unit configured to transmit a first set of instructions to the internal communication unit over a first communications connection, a second external device comprising a third communication unit configured to transmit a first cryptographic hash to the internal communication unit, wherein the internal controller is configured to receive, via the internal communication unit, the first set of instructions and the first cryptographic hash and verify the integrity of the first set of instructions based on the first cryptographic hash, and wherein the active portion comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system for communication instructions, the system comprising: an implant adapted to be implanted in a patient, the implant comprising an active unit, an internal communication unit and an internal controller, an external device comprising an external communication unit configured to transmit a first set of instructions to the internal communication unit over a first communications connection, a second external device comprising a third communication unit configured to transmit a first cryptographic hash to the internal communication unit, wherein the internal controller is configured to receive, via the internal communication unit, the first set of instructions and the first cryptographic hash and verify the integrity of the first set of instructions based on the first cryptographic hash, and wherein the active portion comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system for communication instructions, the system comprising: an implant adapted to be implanted in a patient, the implant comprising an active unit, an internal communication unit and an internal controller, an external device comprising an external communication unit configured to transmit a first set of instructions to the internal communication unit over a first communications connection, a second external device comprising a third communication unit configured to transmit a first cryptographic hash to the internal communication unit, wherein the internal controller is configured to receive, via the internal communication unit, the first set of instructions and the first cryptographic hash and verify the integrity of the first set of instructions based on the first cryptographic hash, and wherein the active portion comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system for communication instructions, the system comprising: an implant adapted to be implanted in a patient, the implant comprising an active unit, an internal communication unit and an internal controller, an external device comprising an external communication unit configured to transmit a first set of instructions to the internal communication unit over a first communications connection, a second external device comprising a third communication unit configured to transmit a first cryptographic hash to the internal communication unit, wherein the internal controller is configured to receive, via the internal communication unit, the first set of instructions and the first cryptographic hash and verify the integrity of the first set of instructions based on the first cryptographic hash, and wherein the active portion comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any of the preceding embodiments, wherein the internal controller is configured to verify the integrity of the first set of instructions using a cyclic redundancy check.
6. The system according to any of the preceding embodiments, wherein the cryptographic hash or metadata comprises a cryptographic hash, and wherein the internal controller is configured to verifying the integrity of the first set of instructions by: calculating a second cryptographic hash for the received first set of instructions using a same cryptographic hash algorithm as the processor, and determining that the first set of instructions has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal.
7. The system according to embodiment 6, wherein the cryptographic hash algorithm comprises one of:
8. The system according to any of embodiments 6-7, wherein the cryptographic hash is a signature obtained by using a private key of the implant, and wherein the internal controller is configured to verifying the first set of instructions by the signature using a public key corresponding to the private key.
9. The system according to any of embodiments 6-8, wherein the cryptographic hash or metadata comprises a metadata, and wherein the internal controller is configured to verifying the integrity of the data by: obtaining a second metadata for the received first set of instructions, and determining that the first set of instructions has been correctly received based on that metadata and the second metadata are equal.
10. The system according to embodiment 9, wherein the metadata comprises: a length of the data, a timestamp, . . .
11. The system according to any of the preceding embodiments, wherein the external device is separate from the second external device. 12. The system according to any of the preceding embodiments, wherein the internal controller is configured to communicate with the second external device using a different protocol than a protocol used for communication with the external device.
13. The system according to any of the preceding embodiments, wherein the internal communication unit comprises a wireless transceiver for communication with the external device, and a conductive member for communicating with the second external device, wherein the second external device comprises a second conductive member.
14. The system according to embodiment 13, wherein the communication between the internal communication unit and the second external device is performed using the patient’s body as a conductor.
15. The system according to any of embodiments 1 - 14, wherein the internal controller is configured to transmit information relating to the received first set of instructions to the external device, and the external device is configured to confirm that the information relates to the first set of instructions transmitted by the external device.
16. The system according to any of embodiments 1 - 15, wherein the internal controller is configured to: calculating a second cryptographic hash for the first set of instructions, comparing the second cryptographic hash with the first cryptographic hash, determining that the first set of instructions are authentic based on that the second cryptographic hash is equal to the first cryptographic hash, and upon verification of the authenticity of the first set of instructions, storing them at the implant.
17. The system according to any of embodiments 1 - 16, wherein the external device is configured to transmit the first set of instructions, and wherein the first set of instructions comprises a cryptographic hash corresponding to a previous set of instructions.
18. The system according to any of embodiments 1 - 17, wherein the internal controller is connected to or comprising a first sensor adapted to obtain a measurement of a parameter relating to the body of the patient, the external device is connected to or comprising a second sensor adapted to obtain a measurement of the parameter relating to the body of the patient, wherein the first set of instructions comprises the second measurement, and wherein the internal controller is configured to verify the authenticity of the first set of instructions at least based on a comparison of the first and second measurements.
19. The system according to embodiment 18, wherein the first and second parameters relate to a pulse of the patient, a respiration rate of the patient, a temperature of the patient, a sound of the patient, or a physical movement of the patient. 20. The system according to any of embodiments 18 - 19, wherein the measured parameter by the external device is provided with a timestamp, and the measured parameter measured by the implant is provided with a timestamp, wherein the comparison of the parameter measured at the implant to the parameter measured by the external device comprises comparing the timestamp of the measured parameter received from the implant to the time stamp of the measured parameter by the external device.
Aspect 312B eHealth programming predefined steps
1. An implant comprising: an internal computing unit configured to control a function of said implant, said internal computing unit comprises an internal memory configured to store: i. a first control program for controlling the internal computing unit, and ii. a second, configurable or updatable, with predefined program steps, control program for controlling said function of said implant, iii. a set of predefined program steps for updating the second control program, an internal communication unit connected to said internal computing unit and configured to communicate with an external device, wherein said internal computing unit is configured to receive an update to the second control program via said internal communication unit, and a verification function of, connected to, or transmitted to said internal computing unit, said verification function being configured to verify that the received update to the second control program comprises program steps comprised in the set of predefined program steps, wherein the implant further comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. An implant comprising: an internal computing unit configured to control a function of said implant, said internal computing unit comprises an internal memory configured to store: i. a first control program for controlling the internal computing unit, and ii. a second, configurable or updatable, with predefined program steps, control program for controlling said function of said implant, iii. a set of predefined program steps for updating the second control program, an internal communication unit connected to said internal computing unit and configured to communicate with an external device, wherein said internal computing unit is configured to receive an update to the second control program via said internal communication unit, and a verification function of, connected to, or transmitted to said internal computing unit, said verification function being configured to verify that the received update to the second control program comprises program steps comprised in the set of predefined program steps, wherein the implant further comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. An implant comprising: an internal computing unit configured to control a function of said implant, said internal computing unit comprises an internal memory configured to store: i. a first control program for controlling the internal computing unit, and ii. a second, configurable or updatable, with predefined program steps, control program for controlling said function of said implant, iii. a set of predefined program steps for updating the second control program, an internal communication unit connected to said internal computing unit and configured to communicate with an external device, wherein said internal computing unit is configured to receive an update to the second control program via said internal communication unit, and a verification function of, connected to, or transmitted to said internal computing unit, said verification function being configured to verify that the received update to the second control program comprises program steps comprised in the set of predefined program steps, wherein the implant further comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. An implant comprising: an internal computing unit configured to control a function of said implant, said internal computing unit comprises an internal memory configured to store: i. a first control program for controlling the internal computing unit, and ii. a second, configurable or updatable, with predefined program steps, control program for controlling said function of said implant, iii. a set of predefined program steps for updating the second control program, an internal communication unit connected to said internal computing unit and configured to communicate with an external device, wherein said internal computing unit is configured to receive an update to the second control program via said internal communication unit, and a verification function of, connected to, or transmitted to said internal computing unit, said verification function being configured to verify that the received update to the second control program comprises program steps comprised in the set of predefined program steps, wherein the implant further comprises an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The implant according to any preceding embodiment, wherein the predefined program steps comprise setting a variable related to a pressure, a time, a minimum or maximum temperature, a current, a voltage, an intensity, a frequency, an amplitude of electrical stimulation, a feedback, a post-operative mode or a normal mode, a catheter mode, a fibrotic tissue mode, an time open after urination, a time open after urination before bed-time.
6. The implant according to any preceding embodiment, wherein the verification function is configured to reject the update in response to the update comprising program steps not comprised in the set of predefined program steps.
7. The implant according to any preceding embodiment, wherein the verification function is configured to allow the update in response to the update only comprising program steps comprised in the set of predefined program steps.
8. The implant according to any preceding embodiment, wherein the internal communication unit is configured to communicate with the external device via a first wireless connection for receiving the update to the second control program, and a second connection for performing an authentication of the communication with the external device.
9. The implant according to embodiment 8, wherein the second connection is a wireless short-range connection.
10. The implant according to embodiment 8 or 9, wherein the authentication second connection is an electrical connection using the patient’s body as a conductor
11. The implant according to any preceding embodiment, wherein the internal computing unit is further configured to, upon verification, installing the update.
12. The implant according to any preceding embodiment, wherein the internal computing unit has a sleep mode and an active mode, and the implant further comprises a sensor configured to detect a wake signal, and wherein the implant is configured to in response to a detected wake signal set the internal computing unit to the active mode. 13. The implant according to embodiment 12, wherein sensor is configured to detect an acoustic signal as wake signal or wherein the sensor is configured to detect a magnetic signal as the wake signal
14. The implant according to any of embodiments 12-13, wherein the sensor is configured to detect the received signal strength of a signal; and the implant is further configured to set the internal computing unit to the active mode in response to the sensor detecting a signal exceeding a threshold signal strength.
15. The implant according to any of embodiments 12-14, further comprising a second internal computing unit, and wherein the implant is configured to set the internal computing unit to the active mode via the second internal computing unit.
16. The implant according to any of embodiments 12-15, wherein the internal computing unit in the sleep mode is substantially without power, and wherein setting the internal computing unit in the active mode comprises providing the internal computing unit with power.
17. The implant according to embodiment 16, wherein the implant comprises an energy controller for controlling the power supplied to the internal computing unit.
18. The implant according to embodiment 17, wherein the sensor is configured to provide the energy controller with a second wake signal in response to detecting the wake signal, and wherein the energy controller is configured to set the computing unit in the active mode in response to the second wake signal.
19. The implant according to any preceding embodiment, wherein the sensor is configured to detect the received signal strength of a signal; and the internal control unit is further configured to set the internal computing unit to the active mode in response to the sensor detecting a signal exceeding a threshold signal strength.
20. The implant according to any preceding embodiment, wherein the wake signal comprises a predetermined signal pattern; and the implant is further configured to set the processing unit to the active mode in response to the sensor detecting the predetermined signal pattern.
21. The implant according to any preceding embodiment, wherein the sensor is a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor or a magneto-resistive sensor.
22. The implant according to any preceding embodiment, wherein the sensor comprises a third coil having an iron core.
23. The implant according to any preceding embodiment, wherein the sensor is comprised in the internal communication unit.
Aspect 313B eHealth watchdog
1. A system comprising an implant comprising: an internal processor comprising: a first control program for controlling a function of the implant, and a first reset function, said first reset function being configured to restart or reset said first control program in response to: a timer of the first reset function has not been reset, or a malfunction in the first control program the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system comprising an implant comprising: an internal processor comprising: a first control program for controlling a function of the implant, and a first reset function, said first reset function being configured to restart or reset said first control program in response to: a timer of the first reset function has not been reset, or a malfunction in the first control program the system further comprising An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system comprising an implant comprising: an internal processor comprising: a first control program for controlling a function of the implant, and a first reset function, said first reset function being configured to restart or reset said first control program in response to: a timer of the first reset function has not been reset, or a malfunction in the first control program the system further comprising An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system comprising an implant comprising: an internal processor comprising: a first control program for controlling a function of the implant, and a first reset function, said first reset function being configured to restart or reset said first control program in response to: a timer of the first reset function has not been reset, or a malfunction in the first control program the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any preceding embodiment, wherein the first control program comprises a second reset function for resetting the timer of the first reset function.
6. The system according to embodiment 5, wherein the first reset function comprises a timer and the second reset function is configured to reset the timer.
7. The system according to any preceding embodiment, wherein the reset function comprises a first reset function and a second reset function, wherein the first reset function is configured to trigger a corrective function for correcting the first control program, and wherein the second reset function is configured to restart the first control program after the corrective function has been triggered.
8. The system according to any preceding embodiment, wherein the first or second reset function is configured to invoke a hardware reset by activating an internal or external pulse generator which is configured to create a reset pulse for the internal computing unit or the first control program.
9. The system according to any preceding embodiment, wherein the internal computing unit is configured to have an active mode and a sleep mode, and wherein the first reset function is configured to have an active mode and a sleep mode corresponding to the active mode and the sleep mode of the internal computing unit.
10. The system according to any preceding embodiment, further comprising a sensor for measuring a physiological parameter of the patient or a parameter of the implant, and wherein the sensor is configured to invoke the reset function in response to the parameter being above or below a predetermined value.
11. The system according to embodiment 10, wherein the sensor is a pressure sensor adapted to measure a pressure in a part of the implant.
12. The system according to embodiment 11, wherein the pressure sensor is configured to measure a pressure in a reservoir or a restriction device of the implant.
13. The system according to embodiment 10, wherein the sensor is a pressure sensor adapted to measure a pressure in an organ of the patient’s body. 14. The system according to any preceding embodiment, wherein the reset function is configured to be invoked by an electrical reset pulse, and wherein the sensor is adapted to invoke the reset function by activating an internal or external pulse generator which is configured to create a reset pulse for the reset function.
15. The system according to any of embodiments 10-14, wherein the physiological parameter of the patient or a parameter of the implant is a temperature.
16. The system according to any preceding embodiment, wherein the reset function comprises invoking a second control program comprising a safety measure.
17. The system according to embodiment 16, wherein the safety measure comprises controlling a function of the implant.
18. The system according to any preceding embodiment, wherein the internal computing unit is configured to invoke the reset function periodically.
19. The system according to embodiment 18, wherein periodically comprises every 24 hours.
20. The system according to any preceding embodiment, wherein the internal computing unit further comprises a monitoring function for monitoring a function of the implant or the first control program, and wherein the reset function is configured to in response to an incorrect or absent response for the monitoring program, reset or restart the first control program.
21. The system according to any preceding embodiment, wherein the internal computing unit has an active mode and a sleep mode, the sleep mode having a lower energy consumption than the active mode, and wherein the implant further comprises an internal control unit connected to the internal computing unit and adapted to control the mode of the internal computing unit.
22. The system according to embodiment 21, wherein the implant further comprises a second sensor for measuring a physiological parameter of the patient or a parameter of the implant, the second sensor being connected to the internal control unit, and wherein, in response to a sensor measurement differing from, exceeding or being less than a predetermined value, setting the internal computing unit in the active mode.
23. The system according to embodiment 22, wherein the sensor is configured to measure the physical parameter periodically.
Aspect 314B eHealth logging
1. A system comprising an implant adapted for communication with a first external device and a second external device, when the implant is adapted to be implanted in a patient, the implant comprising: a communication unit comprising a wireless receiver configured to receive data from the first external device, and a transmitter configured to transmit data to the second external device, an internal computing unit comprising an updatable control program for controlling a function of said implant, the internal computing unit being connected to the communication unit, and being configured to receive an update or a configuration to the updatable control program from the first external via the communication unit, and the internal computing unit being configured to, when updating the control program, transmit logging data relating to the update to the second external device, and wherein the communication unit is configured to receive data from the first external device via a first communication channel and transmit data to the second external device via a second communication channel, the first and second communication channels being different communication channels the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system comprising an implant adapted for communication with a first external device and a second external device, when the implant is adapted to be implanted in a patient, the implant comprising: a communication unit comprising a wireless receiver configured to receive data from the first external device, and a transmitter configured to transmit data to the second external device, an internal computing unit comprising an updatable control program for controlling a function of said implant, the internal computing unit being connected to the communication unit, and being configured to receive an update or a configuration to the updatable control program from the first external via the communication unit, and the internal computing unit being configured to, when updating the control program, transmit logging data relating to the update to the second external device, and wherein the communication unit is configured to receive data from the first external device via a first communication channel and transmit data to the second external device via a second communication channel, the first and second communication channels being different communication channels the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system comprising an implant adapted for communication with a first external device and a second external device, when the implant is adapted to be implanted in a patient, the implant comprising: a communication unit comprising a wireless receiver configured to receive data from the first external device, and a transmitter configured to transmit data to the second external device, an internal computing unit comprising an updatable control program for controlling a function of said implant, the internal computing unit being connected to the communication unit, and being configured to receive an update or a configuration to the updatable control program from the first external via the communication unit, and the internal computing unit being configured to, when updating the control program, transmit logging data relating to the update to the second external device, and wherein the communication unit is configured to receive data from the first external device via a first communication channel and transmit data to the second external device via a second communication channel, the first and second communication channels being different communication channels the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S 1 ,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system comprising an implant adapted for communication with a first external device and a second external device, when the implant is adapted to be implanted in a patient, the implant comprising: a communication unit comprising a wireless receiver configured to receive data from the first external device, and a transmitter configured to transmit data to the second external device, an internal computing unit comprising an updatable control program for controlling a function of said implant, the internal computing unit being connected to the communication unit, and being configured to receive an update or a configuration to the updatable control program from the first external via the communication unit, and the internal computing unit being configured to, when updating the control program, transmit logging data relating to the update to the second external device, and wherein the communication unit is configured to receive data from the first external device via a first communication channel and transmit data to the second external device via a second communication channel, the first and second communication channels being different communication channels the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any one of preceding embodiments, wherein the update or configuration comprises a set of instructions for the control program.
6. The system according to any one of preceding embodiments, wherein the steps comprise a subset of a set of predefined steps.
7. The system according to any one of preceding embodiments, wherein the second external device is configured to confirm that the update or configuration is correct based on the received logging data.
8. The system according to any one of preceding embodiments, wherein the logging data is related to the receipt of the update or configuration, and the internal computing unit is configured to install the update or configuration in response to receipt of a confirmation that the logging data relates to a correct set of instructions.
9. The system according to any one of preceding embodiments, wherein the logging data is related to the installation of the update or configuration, and wherein the internal computing unit is configured to activate the installation in response to a confirmation that the update or configuration is correct.
10. The system according to any one of preceding embodiments, wherein the update or configuration comprises a plurality of steps, and the update or configuration is received by the internal computing unit in two or more sub steps.
11. The system according to any one of preceding embodiments, further comprising a sensation generator adapted to create a sensation detectable by the user.
12. The system according to any one of preceding embodiments, wherein the internal computing unit is configured to cause the sensation generator to create a sensation detectable by the user in response to the update or configuration being received, in response to the update or configuration being installer or in response to the update or configuration being confirmed.
13. The system according to any one of preceding embodiments, wherein the sensation generator is a vibrator or a speaker.
14. The system according to any one of preceding embodiments, wherein the configuration or update comprises a value for a predetermined parameter.
15. The system according to any one of preceding embodiments, wherein the configuration or update comprises a step from a set of predetermined steps.
16. The system according to any one of preceding embodiments, wherein communication over the first communication channel is performed using a first network protocol, and communication over the second communication channel is performed using a second network protocol, the first and second protocols being different.
17. The system according to any one of preceding embodiments, wherein the network protocol is one from the list of:
• Radio Frequency type protocol
• RFID type protocol
• WLAN type protocol
• Bluetooth type protocol
• BLE type protocol
• NFC type protocol
• 3G/4G/5G type protocol
• GSM type protocol.
18. The system according to any one of preceding embodiments, wherein the second network protocol is one from the list of:
• Radio Frequency type protocol
• RFID type protocol
• WLAN type protocol
• Bluetooth type protocol
• BLE type protocol
• NFC type protocol
• 3G/4G/5G type protocol
• GSM type protocol.
19. The system according to any one of preceding embodiments, wherein the second communication channel is an electrical connection.
Aspect 315B eHealth sleeping internal control unit
1. A system comprising an implant for implanting in a patient, comprising: a controller connected to or comprised in the implant, the controller comprising: a sensor, the sensor being a passive sensor; and a processor having a sleep mode and an active mode; wherein: the sensor is configured to measure a physiological parameter of the patient or a parameter of the implant, and the controller is further configured to, in response to a sensor measurement having a value outside of a predetermined interval, set the processor in the active mode, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system comprising an implant for implanting in a patient, comprising: a controller connected to or comprised in the implant, the controller comprising: a sensor, the sensor being a passive sensor; and a processor having a sleep mode and an active mode; wherein: the sensor is configured to measure a physiological parameter of the patient or a parameter of the implant, and the controller is further configured to, in response to a sensor measurement having a value outside of a predetermined interval, set the processor in the active mode, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system comprising an implant for implanting in a patient, comprising: a controller connected to or comprised in the implant, the controller comprising: a sensor, the sensor being a passive sensor; and a processor having a sleep mode and an active mode; wherein: the sensor is configured to measure a physiological parameter of the patient or a parameter of the implant, and the controller is further configured to, in response to a sensor measurement having a value outside of a predetermined interval, set the processor in the active mode, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system comprising an implant for implanting in a patient, comprising: a controller connected to or comprised in the implant, the controller comprising: a sensor, the sensor being a passive sensor; and a processor having a sleep mode and an active mode; wherein: the sensor is configured to measure a physiological parameter of the patient or a parameter of the implant, and the controller is further configured to, in response to a sensor measurement having a value outside of a predetermined interval, set the processor in the active mode, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any preceding embodiment, wherein: the sensor is configured to measure periodically.
6. The system according to any preceding embodiment, wherein the sensor is a mechanical sensor.
7. The system according to embodiment 6, wherein the sensor comprises a pressure sensor, a piezoelectric sensor, or a bimetal.
8. The system according to any preceding embodiment, wherein: the sensor is configured to measure a physiological parameter of the patient; and the sensor is a pressure sensor.
9. The system according to embodiment 8, wherein: the pressure sensor is adapted to measure a pressure in one or more of: an organ of a patient; a reservoir; and a restriction device.
10. The system according to any preceding embodiment, wherein: the sensor is configured to measure a parameter of the implant; and the sensor is adapted to measure one or more of: a battery status of a battery of the implant; and a temperature of the implant.
11. The system according to any preceding embodiment, wherein the sensor is an analog sensor or a digital sensor.
12. The system according to any preceding embodiment, further comprising a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient.
13. The system according to embodiment 12, wherein the sensation generator is configured to receive the request from the controller of the implant. 14. The system according to embodiment 13, wherein the request is generated by the controller in response to the sensor measurement having the value outside of the predetermined interval.
15. The system according to any of embodiments 12 to 14, wherein the sensation generator is configured to receive the request from an external controller.
16. The system according to any of embodiments 12 to 15, wherein the generated sensation comprises a plurality of sensation components.
17. The system according to any of embodiments 12 to 16, wherein the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; and a heat signal.
18. The system according to any preceding embodiment, further comprising an active unit, communicatively coupled to the processor, for performing controlling or monitoring a bodily function in the patient.
19. The system according to embodiment 18, wherein: the sensor is configured to measure a physiological parameter of the patient; and the active unit is configured to perform the controlling or monitoring in response to a sensor measurement having a value outside of the predetermined interval, after the processor has been set in the active state.
20. The system according to any preceding embodiment, wherein: the controller further comprises: a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit.
21. The system according to embodiment 20, further comprising: a frequency detector, communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit.
22. The system according to embodiment 21, wherein: the frequency detector comprises an antenna.
Aspect 316B eHealth relay instructions
1. A system for transmitting an instruction from a first external device to an implant, comprising: an implant implanted in a human patient, the implant comprising an internal control unit configured to control a function of the implant and configured to receive an instruction from an external device; a first external device configured to receive or determine an instruction to be transmitted to the implant, and to transmit the instruction to a second external device; and a second external device configured to receive the instruction transmitted from the first external device, encrypt the instruction, and transmit the encrypted instruction to the implant, wherein the implant is configured to received and decrypt the instruction, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state.
2. A system for transmitting an instruction from a first external device to an implant, comprising: an implant implanted in a human patient, the implant comprising an internal control unit configured to control a function of the implant and configured to receive an instruction from an external device; a first external device configured to receive or determine an instruction to be transmitted to the implant, and to transmit the instruction to a second external device; and a second external device configured to receive the instruction transmitted from the first external device, encrypt the instruction, and transmit the encrypted instruction to the implant, wherein the implant is configured to received and decrypt the instruction, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system for transmitting an instruction from a first external device to an implant, comprising: an implant implanted in a human patient, the implant comprising an internal control unit configured to control a function of the implant and configured to receive an instruction from an external device; a first external device configured to receive or determine an instruction to be transmitted to the implant, and to transmit the instruction to a second external device; and a second external device configured to receive the instruction transmitted from the first external device, encrypt the instruction, and transmit the encrypted instruction to the implant, wherein the implant is configured to received and decrypt the instruction, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S 1 ,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system for transmitting an instruction from a first external device to an implant, comprising: an implant implanted in a human patient, the implant comprising an internal control unit configured to control a function of the implant and configured to receive an instruction from an external device; a first external device configured to receive or determine an instruction to be transmitted to the implant, and to transmit the instruction to a second external device; and a second external device configured to receive the instruction transmitted from the first external device, encrypt the instruction, and transmit the encrypted instruction to the implant, wherein the implant is configured to received and decrypt the instruction, the system further comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (p 1 ,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any preceding embodiments, wherein the second external device is configured to transmit the encrypted instruction by transmitting the encrypted instruction to the first external device, and wherein the first external device is configured to transmit the encrypted instruction to the implant.
6. The system according to any preceding embodiments, wherein the second external device is configured to transmit the encrypted instruction by transmitting the encrypted instruction to a third external device, and wherein the third external device is configured to transmit the encrypted instruction to the implant.
7. The system according to any preceding embodiments, wherein the second external device is an encryption device communicatively coupled to the first external device, and wherein any communication between the implant and the second external device is relayed through the first external device. 8. The system according to any preceding embodiments, wherein the internal control unit is configured to run the decrypted instruction for controlling a function of the implant.
9. The system according to any preceding embodiments, wherein the first external device is configured to display a user interface for receiving the instruction.
10. The system according to any preceding embodiments, wherein the implant comprises a set of a predefined program steps, and wherein the implant is configured to verify that the received instruction is comprised in the predefined program steps.
11. The system according to embodiment 10, wherein the implant is configured to reject the instruction in response to the instruction not being comprised in the set of predefined program steps.
12. The system according to any preceding embodiments, wherein the implant is configured to allow the instruction in response to the instruction being comprised in the set of predefined program steps.
13. The system according to any preceding embodiments, wherein the first external device and the implant are configured to communicate over a wireless connection.
Aspect 317B Energy general microphone
1. A system comprising an implantable controller for controlling an energized implant, when implanted in a patient, the controller comprises: a computing unit, at least one microphone, wherein the at least one microphone is configured to register a sound related to at least one of: a bodily function, and a function of the implant, the system further comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, the vessel member comprising an inner surface configured to face an outer surface of the blood vessel, wherein the at least one vessel member is configured to: in a first state of the blood vessel, be positioned such that the inner surface of the vessel member is placed at a distance from the outer surface of the blood vessel, such that the inner surface of the vessel member does not engage the outer surface of the blood vessel, and in a second state of the blood vessel, when the aneurysm expands, engage the outer surface of the blood vessel, for supporting the blood vessel, and an attachment device for attaching the at least one vessel member to a structure in the patient’s body, such that the distance between the inner surface of the vessel member and the outer surface of the blood vessel can be maintained when the blood vessel is in the first state. 2. A system comprising an implantable controller for controlling an energized implant, when implanted in a patient, the controller comprises: a computing unit, at least one microphone, wherein the at least one microphone is configured to register a sound related to at least one of: a bodily function, and a function of the implant, the system further comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
3. A system comprising an implantable controller for controlling an energized implant, when implanted in a patient, the controller comprises: a computing unit, at least one microphone, wherein the at least one microphone is configured to register a sound related to at least one of: a bodily function, and a function of the implant, the system further comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising a vessel member configured for at least partially enclosing a portion of the blood vessel in a region of an aneurysm, the vessel member having an inner surface (IS) comprising at least a first and second portion, each portion being configured to face an outer surface of the blood vessel, the vessel member comprising a first segment (SI) comprising the first portion (Pl), and a second segment (S2) comprising the second portion (P2), wherein the first segment (SI) comprises a first connection interface, and the second segment (S2) comprises a second connection interface, wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S 1 ,S2) can be connected for creating the vessel member configured to follow the shape of the blood vessel in the direction of the length extension (LE) of the blood vessel, and wherein at least one of: the inner surface (IS) of the vessel member comprises at least one curvature extending over the first and second portions (P1,P2) in the direction of the length extension (LE) of the blood vessel, for enabling the inner surface of the vessel member to follow a curvature of the blood vessel, and the first and second portions (P1,P2) are angled or displaced relative to each other, for enabling the inner surface (IS) of the vessel member to follow a curvature of the blood vessel in the direction of the length extension (LE) of the blood vessel.
4. A system comprising an implantable controller for controlling an energized implant, when implanted in a patient, the controller comprises: a computing unit, at least one microphone, wherein the at least one microphone is configured to register a sound related to at least one of: a bodily function, and a function of the implant, the system further comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising an implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the aorta at the aortic arch of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, the aortic arch having a curvature in the direction of the length extension (LE) of the aorta, the at least one adjustable vessel member comprising an inner surface (IS) configured to face an outer surface of the aorta, wherein at least one of: the inner surface (IS) of the at least one adjustable vessel member comprises at least one curvature configured to be placed in the direction of the length extension (LE) of the aorta, such that the inner surface (IS) follows the curvature of the aortic arch, and the inner surface (IS) of the at least one adjustable vessel member comprises at least a first and a second portion (pl,p2), and wherein the first and second portions (p 1 ,p2) are angled or displaced relative to each other, such that the at least one adjustable vessel member can follow the curvature of the aortic arch in the direction of the length extension (LE) of the aorta.
5. The system according to any preceding embodiments, wherein the implantable controller further comprises at least one implantable housing for sealing against fluid, and wherein the computing unit and the microphone are placed inside of the housing. 6. The system according to any preceding embodiments, wherein the computing unit is configured to derive a pulse of the patient from the registered sound related to a bodily function.
7. The system according to any preceding embodiments, wherein the computing unit is configured to derive information related to the patient urinating from the registered sound related to a bodily function.
8. The system according to any preceding embodiments, wherein the computing unit is configured to derive information related to a bowel activity of the patient from the registered sound related to a bodily function.
9. The system according to any preceding embodiments, wherein the computing unit is configured to derive information related to a functional status of the implant from the registered sound related to a function of the implant.
10. The system according to embodiment 9, wherein the computing unit is configured to derive information related to the functional status of an operation device of the implant, from the registered sound related to a function of the implant.
11. The system according to embodiment 10, wherein the computing unit is configured to derive information related to the functional status of at least one of: a motor, a pump and a transmission of the operation device of the implant from, the registered sound related to a function of the implant.
12. The system according to any one of the preceding embodiments, further comprising a transceiver, and wherein the controller is configured to transmit a parameter derived from the sound registered by the at least one microphone using the transceiver.

Claims

1. An implantable system for handling an aneurysm in a blood vessel of a patient, the system comprising: at least one adjustable vessel member configured for at least partially enclosing a portion of the blood vessel of the patient, an implantable operation device for post-operatively adjusting the at least one adjustable vessel member, wherein the at least one adjustable vessel member comprises at least one of: an opening for accommodating at least one branching blood vessel connected to the blood vessel, and a recess for accommodating at least one branching blood vessel connected to the blood vessel.
2. The implantable system according to claim 1, wherein the at least one opening comprises at least one through-hole for accommodating the at least one branching blood vessel connected to the blood vessel.
3. The implantable system according to claim 2, wherein the through-hole has a cross sectional area, in a plane perpendicular to the radius of the blood vessel in the range 4mm2 - 100mm2.
4. The implantable system according to any one of claims 2 - 3 , wherein the through-hole is annular.
5. The implantable system according to claim 4, wherein the annular through-hole has a diameter in the range 1mm - 10mm.
6. The implantable system according to any one of the preceding claims, wherein the at least one opening comprises at least one slit for accommodating the at least one branching blood vessel.
7. The implantable system according to claim 6, wherein the slit adapted to accommodate at least one branching blood vessel extends substantially in the direction of the length extension (LE) of the blood vessel.
8. The implantable system according to claim 6, wherein the slit adapted to accommodate at least one branching blood vessel extends in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
9. The implantable system according to any one of the preceding claims, wherein the distance between an edge of the at least one opening and the branching blood vessel is configured to be between 1mm and 10mm.
10. The implantable system according to any one of the preceding claims, wherein the adjustable vessel member comprises at least two openings radially displaced at an angle in the range 10° - 180° in relation to each other.
11. The implantable system according to any one of the preceding claims, wherein the recess comprises at least one furrow adapted to accommodate at least one branching blood vessel.
12. The implantable system according to claim 11, wherein the furrow adapted to accommodate the at least one branching blood vessel extends substantially in the direction of the length extension (LE) of the blood vessel.
13. The implantable system according to claim 11, wherein the furrow adapted to accommodate the at least one branching blood vessel extends in a direction at an angle in relation to the direction of the length extension (LE) of the blood vessel, the angle being an angle in the range 10° - 45°.
14. The implantable system according to any one of the preceding claims, wherein the recess extends on an inner surface of the adjustable vessel member, such that the recess accommodates the branching blood vessel between the adjustable vessel member and the blood vessel.
15. The implantable system according to any one of the preceding claims, wherein the adjustable vessel member comprises at least two recesses radially displaced at an angle in the range 10° - 180° in relation to each other.
16. The implantable system according to any one of the preceding claims, wherein the adjustable vessel member comprises at least one recess connected to at least one opening, such that a branching blood vessel can extend in the recess and further through the opening.
17. The implantable system according to any one of the preceding claims, wherein the adjustable vessel member comprises a first segment (SI) and a second segment (S2), wherein the first segment (SI) comprises a first connection interface and the second segment (S2) comprises a second connection interface, and wherein the second connection interface is configured to mate with the first connection interface, such that the first and second segments (S1,S2) can be connected for at least partially forming the adjustable vessel member.
18. The implantable system according to claim 17, wherein the first segment (SI) comprises a first portion (Pl) configured to encircle the blood vessel and the second segment comprises a second portion (P2) comprising at least one of: the opening for accommodating the at least one branching blood vessel, and the recess for accommodating the at least one branching blood vessel.
19. The implantable system according to any of claims 17 and 18, wherein the first and second segments (S1,S2), when assembled, cover a distance of 5mm - 100mm of the blood vessel in the direction of the length extension (LE) of the blood vessel.
20. The implantable system according to any one of claims 17 - 19, wherein the first and second segments (S 1, S2) forms a bent channel configured to be placed around at least a portion of the blood vessel.
EP22765165.0A 2021-08-30 2022-08-26 A device for treatment of aneurysm of a blood vessel Pending EP4395703A1 (en)

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PCT/EP2021/073893 WO2022043555A1 (en) 2020-08-31 2021-08-30 Providing remotely energy for an implant comprising a capacitor for providing necessary energy bursts for the energy consuming parts of the implant
PCT/EP2022/073773 WO2023031036A1 (en) 2021-08-30 2022-08-26 A device for treatment of aneurysm of a blood vessel

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AU (1) AU2022340836A1 (en)
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CN117045303B (en) * 2023-08-16 2024-02-02 南京思脉德医疗科技有限公司 Wire changing device of embolic coil conveying system
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EP4670650A3 (en) * 2007-10-11 2026-01-21 Implantica Patent Ltd. A device for treatment of aneurysm
US8702776B2 (en) * 2010-04-26 2014-04-22 Paul Heltai Method for deploying a sleeve and tubing device for restricting and constricting aneurysms and a sleeve and tubing device and system
EP3849468A4 (en) * 2018-09-12 2022-05-25 Endologix LLC INFLATABLE INFLATING STRUCTURE AND INFLATABLE CUFF STENT GRAFT SYSTEMS AND PROCEDURES

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