WO2024133956A1 - Traitement du reflux gastro-œsophagien pathologique - Google Patents

Traitement du reflux gastro-œsophagien pathologique Download PDF

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Publication number
WO2024133956A1
WO2024133956A1 PCT/EP2023/087772 EP2023087772W WO2024133956A1 WO 2024133956 A1 WO2024133956 A1 WO 2024133956A1 EP 2023087772 W EP2023087772 W EP 2023087772W WO 2024133956 A1 WO2024133956 A1 WO 2024133956A1
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WO
WIPO (PCT)
Prior art keywords
implantable medical
medical device
movement restriction
recess
restriction device
Prior art date
Application number
PCT/EP2023/087772
Other languages
English (en)
Inventor
Peter Forsell
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
Application filed by Implantica Patent Ltd filed Critical Implantica Patent Ltd
Priority to PCT/EP2024/050047 priority Critical patent/WO2024133974A1/fr
Publication of WO2024133956A1 publication Critical patent/WO2024133956A1/fr

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Classifications

    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
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    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
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    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
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    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
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    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00411—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like actuated by application of energy from an energy source outside the body
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
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    • A61B2017/00681—Aspects not otherwise provided for
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    • A—HUMAN NECESSITIES
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A61B2017/00827—Treatment of gastro-esophageal reflux
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/0084—Material properties low friction
    • A61B2017/00849—Material properties low friction with respect to tissue, e.g. hollow organs
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs
    • 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
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F2005/0016—Implantable devices or invasive measures comprising measuring means
    • A61F2005/002—Implantable devices or invasive measures comprising measuring means for sensing mechanical parameters
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A61F5/0079—Pyloric or esophageal obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0507—Electrodes for the digestive system
    • A61N1/0509—Stomach and intestinal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Definitions

  • the present inventive concept generally relates to medial implants. More specifically the inventive concept relates to medical implants for treating gastroesophageal reflux disease (GERD).
  • GEF gastroesophageal reflux disease
  • Gastroesophageal reflux disease is a condition resulting in mucosal damage in the esophagus caused by recurring occurrence of acid reflux in the esophagus.
  • GERD can be treated in a number of different ways, including both medical and surgical treatments.
  • An example of a surgical treatment is Nissen fundoplication surgery, in which the upper curve of the stomach (the fundus) is wrapped around the lower esophageal sphincter (LES) to strengthen the sphincter, prevent acid reflux, and repair a hiatal hernia. This method however risks causing a constriction of the food passageway, making it more difficult for the patient to swallow.
  • Anglechik prosthesis in which a device formed like a horseshoe is placed around the esophagus above the cardia.
  • the intended effect is to prevent the cardia from slipping up into the thorax cavity.
  • this device is associated with a number of complications, including migrating through and damaging the esophagus.
  • 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.
  • a method for treating reflux disease of a human patient by implanting a movement restriction device is provided.
  • the movement restriction device is arranged to restrict movement of the cardia of the patient’s stomach towards the diaphragm to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the method comprises attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position, attaching the fundus of the stomach of the patient to the esophagus of the patient in a second position, at a distance from the first position in a cranial-caudal direction, and positioning the movement restriction device between the first and second position, such that the movement restriction device is secured in the cranial-caudal direction by the attachments between the fundus and the esophagus in the first and second positions.
  • the step of attaching the fundus of the stomach of the patient to the esophagus of the patient in a second position is preceded by the step of positioning the movement restriction device between the first and second position.
  • At least one of the steps of: attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position, and attaching the fundus of the stomach of the patient to the esophagus of the patient in a second position comprises suturing or stapling the fundus to the esophagus.
  • the steps of attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position and attaching the fundus of the stomach of the patient to the esophagus of the patient in a second position are preceded by the step of dissecting the stomach of the patient.
  • At least one of the steps of attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position and attaching the fundus of the stomach of the patient to the esophagus of the patient in a second position is performed using a translaminar instrument configured to be inserted through the esophagus of the patient.
  • the step of positioning the movement restriction device between the first and second position is performed using an abdominal instrument configured to enter the abdomen of the patient through an incision made in the skin of the patient.
  • At least one of the steps of attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position and attaching the fundus of the stomach of the patient to the esophagus of the patient in a second position may be performed using an abdominal instrument configured to enter the abdomen of the patient through an incision made in the skin of the patient.
  • the step of attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position may comprise attaching the fundus of the stomach of the patient to the esophagus of the patient at a distance from the angle of His exceeding 5mm, or exceeding 10mm, or exceeding 20mm or exceeding 30mm.
  • the step of positioning the movement restriction device between the first and second position may comprise positioning the center of mass of the movement restriction device in a plane extending perpendicular to the cranial - caudal direction at a distance from the angle of His exceeding 20mm, or exceeding 30mm.
  • the step of positioning the movement restriction device between the first and second position may comprise positioning the upper-most point of the movement restriction device in a plane extending perpendicular to the cranial - caudal direction at a distance from an upper-most point of the cardia exceeding 5mm, or exceeding 10mm.
  • the step of positioning the movement restriction device between the first and second position may comprise positioning the center of mass of the movement restriction device in a plane extending perpendicular to the cranial - caudal direction at a distance from an upper-most point of the cardia exceeding 1mm, or exceeding 5mm, or exceeding 10mm.
  • the movement restriction device may in any of the embodiments herein have a rounded shape, which may be a spherical shape.
  • the step of positioning the movement restriction device may comprise positioning a movement restriction device encircling at least 1/3 of the esophagus in a plane extending perpendicular to the cranial
  • the step of positioning the movement restriction device may comprise positioning a movement restriction device comprising a curved outer surface, such that the curved outer surface faces the esophagus.
  • the curved outer surface may comprise a radius of curvature corresponding to or exceeding the radius of curvature of the esophagus, such that the curved outer surface comprises a radius of curvature corresponding to or exceeding the radius of curvature of the esophagus.
  • the step of positioning the movement restriction device may comprise positioning a movement restriction device comprising an electrode arrangement configured to electrically stimulate muscle tissue of the portion of the fundus and/or the serosa to improve the conditions for long term implantation of the movement restriction device.
  • the method may in any of the embodiments comprise implanting an implantable energy source configured to provide the electrode with electrical power.
  • the implantable energy source may be arranged inside the movement restriction device or may be placed subcutaneously.
  • the method may further comprise implanting an implantable charger configured to be electrically connected to the implantable energy source and enable charging of the implantable energy source by the external energy source.
  • the method may further comprise implanting a controller configured to be operably connected to the electrode arrangement for controlling the electrical stimulation of the muscle tissue.
  • the controller may be configured to control the electrical stimulation such that the muscle tissue is stimulated by a series of electrical pulses PL1, PL2, PL3, PL4.
  • the electrical stimulation signal may comprise a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms and a pulse amplitude of 3-10 mA.
  • the controller may comprise a wireless remote control.
  • the step of positioning the movement restriction device comprises positioning a movement restriction device having a constricting state for hindering fluid from passing from the stomach into the esophagus and an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the step of positioning the movement restriction device may comprise positioning a movement restriction device configured to exert an encircling pressure on the esophagus in the constricting state.
  • the step of positioning the movement restriction device comprises positioning a movement restriction device comprising at least one attractor for resiliently attracting adjacent portions of the movement restriction device to generate the encircling pressure.
  • the attractor may comprise an elastic element or at least two mutually attracting magnets.
  • the apparatus may further comprise a link connecting a first and a second one of said at least two magnets to each other.
  • the step of positioning the movement restriction device may comprise positioning a non- adjustable movement restriction device or in the alternative the step of positioning the movement restriction device may comprises positioning a movement restriction device having an adjustable volume.
  • the apparatus comprises an implantable movement restriction device having a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach, such that the movement restriction device is implanted at a position between the patient’s diaphragm and a portion of the fundus wall, and such that movement of the cardia of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the apparatus further comprises a first electrode arrangement configured to engage and electrically stimulate muscle tissue of the fundus wall portion to exercise the muscle tissue to improve the conditions for long term implantation of the movement restriction device, and a second electrode arrangement configured to engage and electrically stimulate the cardiac sphincter for causing contraction of the cardiac sphincter.
  • the first electrode arrangement is arranged on an outer surface of the movement restriction device.
  • the first electrode arrangement may comprise a plurality of electrode elements, each of which being configured to engage and electrically stimulate the muscle tissue.
  • the first electrode arrangement may comprise a coiled wire for increasing a contact surface between the first electrode arrangement and the muscle tissue and for allowing the first electrode arrangement to follow contraction and relaxation of the muscle tissue.
  • At least one of the first and second electrode arrangement may comprise a bare electrode portion configured to form a metal-tissue interface with the muscle tissue, thereby allowing faradaic charge transfer to the be predominant charge transfer mechanism over said interface.
  • At least one of the first and second electrode arrangement may comprise an electrode portion at least partly covered by a dielectric material configured to form a dielectric-tissue interface with the muscle tissue, thereby allowing for a faradaic portion of the charge transfer mechanism over said interface to be reduced.
  • the second electrode arrangement comprises at least two electrode elements configured to be arranged on opposing sides of the cardiac sphincter.
  • the apparatus may further comprise a holder configured to support the at least two electrode elements at the opposing sides of the cardiac sphincter.
  • the apparatus may further comprise an implantable energy source configured to provide the electrode with electrical power.
  • the implantable energy source may be arranged inside the movement restriction device or outside the movement restriction device, such as subcutaneously.
  • the implantable energy source may comprises a primary cell and/or a secondary cell.
  • the apparatus in any of the preceding embodiments may further comprise a controller configured to be operably connected to the electrode arrangement for controlling the electrical stimulation of the muscle tissue.
  • the controller may be configured to control the electrical stimulation such that the muscle tissue is stimulated by a series of electrical pulses PL1, PL2, PL3, PL4.
  • the controller may be configured to control the electrical stimulation such that a pulse of a first polarity is followed by a pulse of a second, reversed polarity.
  • the controller is configured to generate a pulsed electrical stimulation signal comprising a pulse frequency F of 0.01-150 Hz.
  • the electrical stimulation signal comprises a pulse duration D of 0.01-100 ms.
  • the electrical stimulation signal comprises a pulse amplitude A of 1-15 mA.
  • 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.
  • the electrical stimulation signal may comprise a build-up period XI of 0.01-2 s in which the amplitude is gradually increasing, a stimulation period X2 of 1-60 s, and a stimulation pause X4 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
  • the controller may comprise a wireless remote control and the controller may be configured to indicate a functional status of the implantable energy source. The functional status may indicate a charge level of the implantable energy source.
  • the functional status indicates a temperature of at least one of the implantable energy source, the muscle tissue and the electrode arrangement.
  • the implantable energy source is configured to be charged by an external energy source arranged outside the patient’s body.
  • the apparatus further comprises an implantable charger configured to be electrically connected to the implantable energy source and enable charging of the implantable energy source by the external energy source.
  • the charger may comprise an electromagnetic coil configured to receive electrical power wirelessly from the external energy source, and the charger may be configured to control the charging of the implantable energy source based on the functional status.
  • the charger is configured to control the charging of the implantable energy source by controlling a receipt of electrical power from the external energy source at the implantable charger.
  • the charger is configured to control the charging of the implantable energy source by controlling a transmission of electrical power from the external energy source to the implantable charger.
  • the apparatus may further comprise an implantable sensor S 1 configured to sense actions potentials generated by pacemaker cells of the muscle tissue, and wherein the controller is configured to control the electrical simulation based at least partly on the sensed action potentials, and according to one embodiment, the controller is configured to generate electrical pulses amplifying the sensed action potentials.
  • an implantable sensor S 1 configured to sense actions potentials generated by pacemaker cells of the muscle tissue
  • the controller is configured to control the electrical simulation based at least partly on the sensed action potentials, and according to one embodiment, the controller is configured to generate electrical pulses amplifying the sensed action potentials.
  • the volume of the movement restriction device may be non-adjustable after implantation, in the alternative, a volume of the movement restriction device is adjustable after implantation.
  • the movement restriction device may further comprise an injection port for allowing a fluid to be injected or extracted from the inside of the movement restriction device so as to vary a volume of the movement restriction device after implantation.
  • the movement restriction device may comprise a biocompatible outer surface configured to rest against the fundus wall portion.
  • the movement restriction device may be substantially spherical or egg-shaped.
  • the movement restriction device may be configured to be at least partially invaginated by the fundus wall.
  • the movement restriction device in any of the embodiment herein may be configured to be introduced in the patient’s body by means of a gastroscope or an intraluminal instrument.
  • the movement restriction device may be configured to change its shape to allow it to pass through a trocar during insertion into the patient’s body.
  • the movement restriction device is formed of at least two distinct and separable parts configured to be assembled into the movement restriction device after insertion in the patient’s body.
  • a minimum width of the movement restriction device in any of the embodiments herein, as measured from side to side, may be 20mm or larger, or 30 mm or larger, such as 40 mm or larger.
  • a minimum outer circumference of the movement restriction device may be 150 mm or less, such as 130 mm or less, such as 110 mm or less, such as 90 mm or less, such as 70 mm or less, such as 50 mm or less, such as 30 mm or less.
  • the apparatus comprises an implantable movement restriction device configured to be fixated between an upper portion of the stomach and the thoracic diaphragm of the patient, for restricting the movement of the cardia of the patient towards the thoracic diaphragm.
  • the implantable movement restriction device has a first cross-sectional distance and a second cross-sectional distance, and the movement restriction device is configured to be implanted such that the first cross-sectional distance is more parallel than perpendicular to the cranial-caudal axis of the patient, and the second cross-sectional distance is more perpendicular than parallel to the cranial-caudal axis of the patient.
  • the implantable movement restriction device is adjustable in situ, such that the shape of the implantable movement restriction device can be adjusted by the adjustment of the length of the first cross-sectional distance, such that the length of the first cross- sectional distance can be increased relative to the length of the second cross-sectional distance.
  • the shape of the implantable movement restriction device can be adjusted by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance while the length of a circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the coronal plane of the patient remains constant.
  • the shape of the implantable movement restriction device can be adjusted to an elongated shape by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance.
  • the shape of the implantable movement restriction device can be adjusted by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance, such that the length of the circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the coronal plane of the patient, is increased relative to the length of the circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the transverse plane of the patient.
  • the implantable movement restriction device comprises a lower portion configured to, directly or indirectly, engage the stomach of the patient in a region of the angle of his, such that the function of the implantable movement restriction device is supported by tissue of the stomach in the region of the angle of his.
  • the implantable movement restriction device comprises an upper portion configured to, directly or indirectly, engage the thoracic diaphragm of the patient, and wherein the upper portion comprises at least one curvature.
  • the implantable movement restriction device is configured to be at least partially invaginated by the stomach wall.
  • the implantable movement restriction device may be configured to be at least partially invaginated by the stomach wall of the fundus.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient.
  • the curve may be configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 1/3 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device is configured to encircle at least 1/2 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device comprises a C-shaped cross-section in a plane parallel to the transverse plane of the patient, and the C-shaped cross-section is configured to partially enclose the esophagus of the patient, in another embodiment, the movement restriction device is configured to encircle at least 2/3 of the esophagus in a plane parallel to the transverse plane of the patient.
  • a cross-section of the movement restriction device in a plane parallel to the transverse plane of the patient comprises a closed curve configured to enclose the esophagus of the patient.
  • the movement restriction device is hydraulically adjustable.
  • the movement restriction device may comprise a conduit configured to connect the hydraulically adjustable movement restriction device to an implantable injection port.
  • the movement restriction device may comprise an injection port, such that the hydraulically adjustable movement restriction device can be adjusted by the injection or withdrawal of a hydraulic fluid into the hydraulically adjustable movement restriction device.
  • a portion of the movement restriction device may comprise a bellows, and wherein the injection or withdrawal of a hydraulic fluid into the hydraulically adjustable movement restriction adjusts a length of the bellows.
  • the movement restriction device comprises a wall enclosing a hydraulic adjustment chamber, and the thickness of the wall varies, which affects the alteration of the shape of the movement restriction device as fluid is injected into or withdrawn from the movement restriction device.
  • the shape of the movement restriction device is altered by a thinner portion of the wall enclosing the hydraulic adjustment chamber being deformed more than thicker portions of the wall enclosing the hydraulic adjustment chamber.
  • the movement restriction device is mechanically adjustable and may comprise a mechanical operation device.
  • the movement restriction device comprises a transferring element configured to transfer at least one of: electrical energy, and mechanical force to the mechanically adjustable movement restriction device.
  • the transferring element comprises at least one of: an electrical lead, a shaft for transferring rotating force, and a shaft for transferring linear force.
  • the mechanical operation device comprises an electrical motor.
  • the mechanical operation device may comprise a transmission configured to transform a rotating force generated by the electrical motor into a linear force for adjusting the length of the first cross- sectional distance.
  • a portion of the movement restriction device comprises a bellows, and operation of the mechanical operation device adjusts a length of the bellows.
  • the movement restriction device is electrically adjustable.
  • the movement restriction device comprises at least one material configured to alter shape when exposed to an electrical current or an electrical voltage.
  • a material may comprise at least one electroactive polymer which could be an electroactive polymer selected from a list consisting of: ferroelectric polymers, electrostrictive graft polymers, electrostrictive paper, piezoelectric polymers and liquid crystal elastomers.
  • the movement restriction device further comprises a transferring element configured to transfer electrical energy to the movement restriction device.
  • the length of the first cross-sectional distance is adjustable in situ such that the length of the first cross-sectional distance is 1,2 times the length of the second cross- sectional distance, or 1,3 times the length of the second cross-sectional distance, or 1,5 times the length of the second cross-sectional distance.
  • the length of the first cross-sectional distance is adjustable in situ such that the length of the circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the coronal plane of the patient, is 1,2 times the length of the circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the transverse plane of the patient, or 1,3 times the length of the circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the transverse plane of the patient, or 1,5 times the length of the circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the transverse plane of the patient.
  • the length of the first cross-sectional distance is adjustable in situ such that the center of mass of the movement restriction device in a plane parallel to the transverse plane of the patient is positioned at a distance from the angle of His exceeding 20mm, or exceeding 30mm.
  • the length of the first cross-sectional distance is adjustable in situ such that the center of mass of the movement restriction device in a plane parallel to the transverse plane of the patient is positioned at a distance from an upper-most point of the cardia exceeding 5mm, or exceeding 10mm.
  • the movement restriction device may comprise at least two parts.
  • the apparatus may further comprise an implantable energy source configured to provide the adjustable implantable movement restriction device with electrical power.
  • the implantable energy source may be arranged inside the movement restriction device or arranged subcutaneously.
  • the apparatus may further comprise at least one electrode for electrically stimulating at least one tissue portion of the patient.
  • the movement restriction device comprises has a constricting state for hindering fluid from passing from the stomach into the esophagus and an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the movement restriction device may comprise at least one attractor for resiliently attracting adjacent portions of the movement restriction device to generate an encircling pressure on the esophagus and the attractor may comprise an elastic element.
  • the attractor comprises at least two mutually attracting magnets.
  • the apparatus comprises an implantable movement restriction device configured to be fixated between an upper portion of the stomach and the thoracic diaphragm of the patient, for restricting the movement of the cardia of the patient towards the thoracic diaphragm.
  • the implantable movement restriction device comprises a first portion having a first volume enclosed by material of the implantable movement restriction device, and a second portion, different from the first portion, having a second volume enclosed by material of the implantable movement restriction device.
  • the first volume and the second volumes are equally large and the first volume has a higher density than the second volume, and the second volume has a density below 1000 kg/m3.
  • the first volume comprises a first solid material
  • the first solid material may comprise a polymer material
  • the first solid material comprises at least one of silicone-based material and a polyurethane -based material.
  • the second volume comprises a second solid material
  • the second solid material may comprise a polymer material.
  • the second solid material may comprise at least one of a polypropylene-based and a polyethylene-based material.
  • the first volume may comprise a solid material having a density above 1000 kg/m3 and the second volume may comprise a solid material having a density below 1000 kg/m3.
  • the second volume comprises a fluid, which may be a liquid having a density a below 1000 kg/m3, such as a liquid selected from a list of oil-based liquids, and alcohol-based liquids.
  • the second volume comprises a gas
  • the second volume may comprise a plurality of volumes of gas enclosed by an enclosing material.
  • the second volume comprises a solid polymer material enclosing the enclosing material, and the enclosing material is harder than the solid polymer material.
  • the plurality of volumes of gas enclosed by an enclosing material makes up at least 10 volume percent of the second volume, more preferably at least 20 volume percent of the second volume, and even more preferably at least 30 volume percent of the second volume.
  • the enclosing material may comprise glass.
  • the movement restriction device has an average density below 1100 kg/m3, or below 1050 kg/m3, or below 1000 kg/m3.
  • the movement restriction device comprises a first cross-sectional distance and a second cross-sectional distance.
  • the movement restriction device may be configured to be implanted such that the first cross-sectional distance is more parallel than perpendicular to the cranial- caudal axis of the patient, and the second cross-sectional distance is more perpendicular than parallel to the cranial-caudal axis of the patient.
  • the implantable movement restriction device may be adjustable in situ, such that the shape of the implantable movement restriction device can be adjusted by the adjustment of the length of the first cross-sectional distance, such that the length of the first cross- sectional distance can be increased relative to the length of the second cross-sectional distance.
  • the shape of the implantable movement restriction device can be adjusted by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance while the length of a circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the coronal plane of the patient remains constant.
  • the implantable movement restriction device comprises a lower portion configured to, directly or indirectly, engage the stomach of the patient in a region of the angle of his, such that the function of the implantable movement restriction device is supported by tissue of the stomach in the region of the angle of his.
  • the implantable movement restriction device comprises an upper portion configured to, directly or indirectly, engage the thoracic diaphragm of the patient, and wherein the upper portion comprises at least one curvature.
  • the implantable movement restriction device may in any of the embodiments herein be at least partially invaginated by the stomach wall.
  • the implantable movement restriction device is configured to be at least partially invaginated by the stomach wall of the fundus. According to one embodiment, the implantable movement restriction device comprises at least one circular cross-section.
  • the implantable movement restriction device may in any of the embodiments herein comprise at least two parts, and the at least two parts may be configured to be assembled to form the implantable movement restriction device.
  • the at least two parts may be configured to be connected to each other to form the implantable movement restriction device.
  • the apparatus further comprising an interconnecting part configured to connect to the at least two parts, and at least one of the two parts and the interconnecting part comprises a connecting recess, and at least one of the two parts and the interconnecting part comprises a connecting protrusion, and wherein at least one connecting protrusion and one connecting recess are configured to be interconnected for forming the implantable movement restriction device.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient, and wherein the curve is configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 1/3 of the esophagus in a plane parallel to the transverse plane of the patient, or configured to encircle at least 1/2 of the esophagus in a plane parallel to the transverse plane of the patient, or configured to encircle at least 2/3 of the esophagus in a plane parallel to the transverse plane of the patient.
  • the movement restriction device comprises a C-shaped crosssection in a plane parallel to the transverse plane of the patient, and wherein the C-shaped cross-section is configured to partially enclose the esophagus of the patient.
  • a cross-section of the movement restriction device in a plane parallel to the transverse plane of the patient comprises a closed curve configured to enclose the esophagus of the patient.
  • the movement restriction device has a constricting state for hindering fluid from passing from the stomach into the esophagus and an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the movement restriction device may comprise at least one attractor for resiliently attracting adjacent portions of the movement restriction device to generate an encircling pressure in the esophagus.
  • the attractor may comprise an elastic element or at least two mutually attracting magnets.
  • the apparatus comprises an implantable movement restriction device configured to be at least partly invaginated by the stomach wall of the patient for restricting the movement of the cardia of the patient towards the thoracic diaphragm.
  • the implantable movement restriction device has a first cross-sectional distance and a second cross-sectional distance, the first cross-sectional distance has a first length and the second cross-sectional distance has a second length. The first length is more than 1,5 times the second length.
  • the movement restriction device is configured to be implanted such that the first cross-sectional distance is more parallel than perpendicular to the cranial-caudal axis of the patient, and the second cross-sectional distance is more perpendicular than parallel to the cranial -caudal axis of the patient.
  • the implantable movement restriction device comprises at least a first and a second part configured to be connected to form the implantable movement restriction device.
  • the center of gravity of the first part is positioned on a plane extending perpendicularly from a first half of the first cross-sectional distance and the center of gravity of the second part is positioned on a plane extending perpendicularly from a second half of the first cross- sectional distance, a lower portion of the first part comprises a first connecting portion and the upper portion of the second part comprises a second connecting portion.
  • the first and second connecting portions are configured to be connected to each other and the first and second connecting portions are configured to remain connected to each other by at least one of the first and second parts being supported or compressed by the invagination of the implantable movement restriction device in the stomach wall of the patient, and the first and second parts are capable of disconnecting and separating if the support or compression from at least one of the first and second parts the stomach wall decreases.
  • the first and second connecting portions may be configured to be directly connected to each other, or may be configured to be indirectly connected to each other by an interconnecting part.
  • At least one of: the first part, the second part, and the interconnecting part comprises a connecting recess, and at least one of: the first part, the second part, and the interconnecting part comprises a connecting protrusion and wherein at least one connecting protrusion and one connecting recess are configured to be interconnected for forming the implantable movement restriction device.
  • At least one of the first and second connecting portions comprises a resilient connecting portion and wherein the resilient connecting portion is, directly or indirectly, supported or compressed by the invagination of the implantable movement for connecting, directly or indirectly, the first part to the second part.
  • the resilient connecting portion comprises a resilient protrusion configured to engage a recess for connecting, directly or indirectly, the first part to the second part.
  • the resilient protrusion may be configured to connect and disconnect from a recess in a direction substantially perpendicular to the direction of the first cross-sectional distance.
  • first part comprises a first sub-part a second sub-part
  • second part comprises a first sub-part and a second sub-part
  • Each of the first and second sub-parts may comprise a connecting portion, and each of the first and second sub-parts may be configured to connect and disconnect from the connecting portion of the first part, or the second part of the interconnecting part in a direction substantially perpendicular to the direction of the first cross-sectional distance.
  • the first sub-part and the second sub-part are configured to remain connected to each other by at least one of the first and second parts being supported or compressed by the invagination of the implantable movement restriction device in the stomach wall of the patient, and wherein the first sub-part and the second sub-part are capable of disconnecting from each other and separating if the support or compression from the stomach wall on at least one of the first and second parts decreases.
  • the first part comprises a first and second sub-part, and the first and second sub-parts are configured to remain connected by the first and second sub-parts being supported or compressed by the connecting portion of the second part.
  • the second part is configured to exert a supporting or compressing force on the first part derived from a supporting or compressing force exerted by the stomach wall on the second part.
  • the first part comprises a first sub-part and a second sub-part
  • the second part comprises a first sub-part and a second sub-part
  • the first and second sub-parts of the first part are configured to remain connected to each other by a supporting or compressing force exerted by at least one of the second part and the stomach wall.
  • the first and second sub-parts of the second part are configured to remain connected to each other by a supporting or compressing force exerted by the stomach wall.
  • the implantable movement restriction device further comprises a third part, and the lower portion of the second part comprises a third connecting portion and the upper portion of the third part comprises a fourth connecting portion, such that the first, second and third parts can be connected for forming the implantable medical device.
  • the second part is configured to exert a supporting or compressing force on the first part derived from a supporting or compressing force exerted by the third part on the second part.
  • the third part may be configured to exert a supporting or compressing force on the second part derived from a supporting or compressing force exerted by the stomach wall on the third part.
  • the apparatus further comprises a second interconnecting part, and the third and fourth connecting portions are configured to be connected to the second interconnecting part, such that the first interconnecting part connects the first part to the second part and the second interconnecting part connects the third part to the fourth part.
  • the first and second resilient connecting portions are supported or compressed by a supporting or compressing force exerted by the third part on the second part.
  • the first part comprises a first sub-part and a second sub-part
  • the second part comprises a first sub-part and a second sub-part
  • the third part comprises a first sub-part and a second sub-part.
  • the first and second sub-parts of the first part are configured to remain connected to each other by a supporting or compressing force exerted by at least one of the second part and the stomach wall
  • the first and second sub-parts of the second part are configured to remain connected to each other by a supporting or compressing force exerted by at least one of the third part and the stomach wall
  • the first and second sub-parts of the third part are configured to remain connected to each other by a supporting or compressing force exerted by the stomach wall.
  • the first part comprises a first, a second and a third sub-part and/or the second part comprises a first, a second and a third sub-part, and/or the third part comprises a first, a second and a third sub-part.
  • the first part comprises a first, second, third and fourth sub-part
  • the second part comprises a first, second, third and fourth sub-part
  • the third part comprises a first, second, third and fourth sub-part
  • the movement restriction device is elongated and the first length is more than 2 times the second length, preferably more than 2,5 times the second length and even more preferably more than 3 times the second length.
  • the implantable movement restriction device comprises at least one circular cross-section.
  • the implantable movement restriction device may comprise a first, second and third crosssection in planes spaced apart and parallel to each other, wherein the first and third cross-sections have the same area, and the second cross-section is located between the first and third cross-section and have a smaller area.
  • the implantable movement restriction device further comprises a fourth and fifth cross-section in planes spaced apart and parallel to the planes of the first, second and third cross-sections, wherein the third and fifth cross-sections have the same area, and the fourth cross-section is located between the third and fifth cross-sections and have a smaller area.
  • the implantable movement restriction device may be configured to be fully invaginated.
  • a first portion of the implantable movement restriction device may have a first volume enclosed by material of the implantable movement restriction device, and a second portion of the movement restriction device, separate from the first portion, may have a second volume enclosed by material of the implantable movement restriction device,
  • the first volume and the second volumes are equally large and the first volume has a higher density than the second volume and the second volume has a density below 1000 kg/m3.
  • the first volume comprises a first solid material
  • the first solid material may comprise a polymer material, such as a silicone -based material or a polyurethane -based material.
  • the second volume comprises a second solid material.
  • the second solid material may comprise a polymer material, such as a polypropylene-based and a polyethylenebased material.
  • the first volume may comprise a solid material having a density above 1000 kg/m3 and the second volume may comprise a solid material having a density below 1000 kg/m3.
  • the second volume may comprises a fluid, which could be a liquid having a density a below 1000 kg/m3, such as an oil-based liquid or an alcohol-based liquid.
  • the second volume may comprise a gas, and the second volume may comprise a plurality of volumes of gas enclosed by an enclosing material.
  • the second volume may comprise a solid polymer material enclosing the enclosing material, and the enclosing material may be harder than the solid polymer material.
  • the plurality of volumes of gas enclosed by an enclosing material makes up at least 10 volume percent of the second volume, more preferably at least 20 volume percent of the second volume, and even more preferably at least 30 volume percent of the second volume.
  • the enclosing material may comprise glass.
  • the movement restriction device has an average density below 1100 kg/m3, or an average density below 1050 kg/m3, or an average density below 1000 kg/m3.
  • the movement restriction device comprises a first cross-sectional distance and a second cross-sectional distance.
  • the implantable movement restriction device may be adjustable in situ, such that the shape of the implantable movement restriction device can be adjusted by the adjustment of the length of the first cross-sectional distance, such that the length of the first cross- sectional distance can be increased relative to the length of the second cross-sectional distance.
  • the shape of the implantable movement restriction device can be adjusted by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance while the length of a circumference of a cross-section of the implantable movement restriction device, in a plane parallel to the coronal plane of the patient remains constant.
  • the first part may in any of the embodiments herein comprise an upper portion configured to, directly or indirectly, engage the thoracic diaphragm of the patient, and the upper portion may comprise at least one curvature.
  • the apparatus comprises an implantable movement restriction device configured to be at least partly invaginated by the stomach wall of the patient for restricting the movement of the cardia of the patient towards the thoracic diaphragm.
  • the implantable movement restriction device comprising sensor configured to sense at least one of a force and a pressure, for monitoring a pressure or force exerted by the implantable movement restriction device on the stomach wall of the patient.
  • the senor is fixated to a surface of the implantable movement restriction device and/or integrated in the implantable movement restriction device.
  • the sensor could comprise a strain gauge-based sensor, such as a piezoresistive or piezoelectric strain gauge-based sensor or an optical strain gauge-based sensor.
  • the sensor could comprise a capacitive sensor or an electromagnetic sensor.
  • the implantable movement restriction device comprises at least one enclosed chamber comprising a fluid, and the sensor is configured the sense a pressure in the fluid.
  • the apparatus may further comprise at least one conduit and a sensor unit configured to house the sensor, and the conduit could be in fluid connection with the enclosed chamber of the implantable movement restriction device and with the sensor unit, such that the sensor can sense the pressure in the fluid in the enclosed chamber of the implantable movement restriction device through the fluid connection provided by the conduit.
  • the apparatus further comprises an implantable energy source for powering the sensor and an implantable controller connected to the sensor.
  • the implantable controller may comprise a wireless transceiver configured to receive a sensor signal from the sensor and transmit a wireless signal derived from the sensor signal to a unit external to the body of the patient.
  • the implantable movement restriction device has a size such that the implantable movement restriction device can be fully invaginated by the fundus wall of the patient.
  • the apparatus may further comprise at least one lead connected to the sensor, and the lead may be configured to connect the sensor to an external device configured to remain outside the patient’s body.
  • the apparatus may further comprise a connector for detachably connecting the sensor to the lead, such that the lead can be disconnected from the sensor.
  • the sensor may be detachably attached to the implantable movement restriction device, such that the sensor can be detached from the implantable movement restriction device by pulling on the lead and the sensor may be detachably attached to the implantable movement restriction device using an adhesive.
  • the implantable movement restriction device may in any of the embodiments herein have a size of less than 200cm2, preferably less than 100cm2, and more preferably less than 50cm2.
  • the movement restriction device is elongated, and a first cross- sectional distance has a first length, and a second cross-sectional distance has a second length.
  • the first length is more than 1,2 times the second length, preferably more than 1,5 times the second length and even more preferably more than 2 times the second length.
  • the implantable movement restriction device comprises at least one circular cross-section.
  • the implantable movement restriction device comprises a first, second and third cross-section in planes spaced apart and parallel to each other.
  • the first and third crosssections have the same area, and the second cross-section is located between the first and third crosssection and have a smaller area.
  • the implantable movement restriction device comprises at least two parts, or at least three parts, or at least 4 parts. According to one embodiment, the at least two parts are configured to be assembled to form the implantable movement restriction device and the at least two parts may be configured to be connected to each other to form the implantable movement restriction device.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient, and the curve is configured to partially enclose the esophagus of the patient.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient.
  • the curve may be configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 1/3 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device is configured to encircle at least 1/2 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device comprises a C-shaped cross-section in a plane parallel to the transverse plane of the patient, and the C-shaped cross-section is configured to partially enclose the esophagus of the patient, in another embodiment, the movement restriction device is configured to encircle at least 2/3 of the esophagus in a plane parallel to the transverse plane of the patient.
  • a cross-section of the movement restriction device in a plane parallel to the transverse plane of the patient comprises a closed curve configured to enclose the esophagus of the patient.
  • the implantable movement restriction device may in any of the embodiments comprise at least one circular cross-section.
  • a surgical instrument for assisting in a surgical procedure for implanting an implantable movement restriction device is further provided.
  • the movement restriction device is configured to be at least partly invaginated by the stomach wall of the patient for restricting the movement of the cardia of the patient towards the thoracic diaphragm.
  • the surgical instrument comprises a handling portion configured to remain outside of the body of the patient in use, a distal portion configured to be inserted into the body of the patient, and a lead at least partially attached to the distal portion and configured to be connected to a sensor for sensing at least one of a force and a pressure, for monitoring a pressure or force exerted by the implantable movement restriction device on the stomach wall of the patient during implantation.
  • the distal portion comprises a holding device connected to the handling portion and configured to be inserted into the body of the patient and to engage the movement restriction device.
  • the holding device comprises an elongated portion configured to be inserted into the implantable movement restriction device.
  • the holding device comprises a gripping portion configured to grip the implantable movement restriction device.
  • the surgical instrument may be configured for placement of the implantable movement restriction device, and the surgical instrument further comprises a sleeve connected to the handling portion, and the holding device is configured to be partially placed within the sleeve and be displaceable in relation to the sleeve.
  • the handling of the handling portion creates relative displacement of the holding device in relation to the sleeve, which disengages the holding device from the movement restriction device for performing the placement of the movement restriction device.
  • the distal portion is bent in relation to the primary length axis of the surgical instrument, and the distal portion may be bent more than 20° in relation to the primary length axis of the instrument.
  • the distal portion is flexible or bendable.
  • the bending of the distal portion is controllable from the handling portion.
  • the surgical instrument is an abdominal instrument configured to be inserted into the abdomen of the patent during an open surgical procedure.
  • the surgical instrument is a laparoscopic instrument configured to be inserted into the abdomen of the patient through a trocar
  • the surgical instrument is a gastroscopic instrument configured to be inserted into the body of the patient through the esophagus of the patient.
  • the surgical instrument further comprises the sensor.
  • the sensor may be configured to be detachably attached to the implantable movement restriction device, such that the sensor can be detached from the implantable movement restriction device and removed from the body of the patient during the surgical procedure.
  • the senor is configured to be attached to a surface of the implantable movement restriction device or attached in the implantable movement restriction device.
  • the sensor may be configured to be detachably attached to the implantable movement restriction device using an adhesive.
  • the surgical instrument may further comprise a connector for detachably connecting the sensor to the lead, such that the lead can be disconnected from the sensor.
  • the sensor could comprise a strain gauge-based sensor, such as a piezoresistive or piezoelectric strain gauge-based sensor, or an optical strain gauge-based sensor, or a capacitive sensor, or an electromagnetic sensor.
  • the implantable movement restriction device comprises at least one enclosed chamber comprising a fluid
  • the sensor is a sensor configured the sense a pressure in a fluid
  • the surgical instrument further comprises an energy source for powering the sensor and a controller connected to the sensor.
  • the controller may be an external device configured to remain on the outside of the patient when the surgical instrument is in use, and the controller is configured to receive a sensor signal from the sensor via the lead and provide an output on the basis the sensor signal.
  • the controller comprises an output device configured to provide an output to a person, the output device comprises at least one unit selected from a list consisting of a unit providing audio output, a unit providing visual output, such as a lighting unit or a display unit, and a unit providing haptic output.
  • An apparatus for treating reflux disease of a human patient comprising an elongated core having a length allowing the core to at least partly encircle the esophagus of the patient.
  • the core comprises a first length variability function allowing the core to be arranged in a constricting state for hindering fluid from passing from the stomach 10 into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing; and a second length variability function for post-operatively adjusting the length that the core has in its constricting state.
  • the second length variability function comprises a hydraulic length variability function and may comprise at least one hydraulic chamber, and the length of the core can be post-operatively adjusted by injection of a fluid into, or withdrawal of a fluid from, the at least one hydraulic chamber.
  • the hydraulic chamber may comprise at least one pleated portion, such as at least one bellows.
  • the elongated core comprises a wall enclosing the hydraulic chamber, and the thickness of the wall varies affecting the alteration of the shape of the hydraulic chamber as fluid is injected into or withdrawn from the hydraulic chamber.
  • the hydraulic chamber comprises at least one implantable injection port, or is connected to at least one implantable injection port.
  • the second length variability function comprises a mechanical length variability function
  • the mechanical length variability function may comprise a powered mechanical length variability function
  • the powered mechanical length variability function may comprise at least one of: an electrical motor, an electromagnet, and an electroactive material.
  • the movement restriction device comprises a transferring element configured to transfer at least one of electrical energy, and mechanical force to the mechanical length variability function.
  • the transferring element comprises at least one of: an electrical lead, a shaft for transferring rotating force, and a shaft for transferring linear force.
  • the mechanical operation device may comprise a transmission configured to transform a rotating force generated by the electrical motor into a linear force for adjusting the length of the first cross- sectional distance.
  • the first length variability function comprises a plurality of portions that are movable relative to each other.
  • the first length variability function comprises an attractor for resiliently attracting adjacent portions of the elongated core to one another.
  • the attractor may comprise an elastic element or may comprise at least two mutually attracting magnets.
  • the apparatus further comprises a link connecting a first and a second one of said at least two magnets to each other.
  • the elongated core is configured to exert an encircling pressure on the esophagus in the constricting state.
  • the apparatus comprises two end portions configured to be coupled to each other to form a closed ring around the esophagus and the end portions may be configured to be releasably attached to each other and may comprise a respective interlockable attacher.
  • the elongated core comprises a plurality of bodies configured to be arranged in an annular array around the esophagus.
  • the elongated core further comprises a plurality of links, each of which extending between a respective pair of bodies arranged adjacent to each other.
  • At least one of the plurality of bodies comprises the second length variability function for post-operative ly adjusting the length of the core in its constricting state.
  • At least one of the plurality of bodies comprises the hydraulic chamber for post-operatively adjusting the length of the core in its constricting state.
  • the elongated core may have a size allowing at least a portion of the elongated core to protrude above the cardiac sphincter of the patient, when implanted, such that movement of the cardia towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening 32 into the patient’s thorax.
  • the elongated core has a maximum height exceeding 2 cm, as measured in a normal direction to the plane in which the elongated core extends when encircling the esophagus.
  • the maximum height may be 3 cm or more, such as 4 cm or more, such as 5 cm or more.
  • the elongated core is configured to be implanted such that a portion of the elongated core having the maximum height is arranged at the fundus side of the esophagus.
  • the elongated core has a first cross-sectional distance and a second cross-sectional distance, and wherein the elongated core is configured to be implanted such that the first cross-sectional distance is more parallel than perpendicular to the cranial-caudal axis of the patient, and the second cross-sectional distance is more perpendicular than parallel to the cranial -caudal axis of the patient, and the elongated core is adjustable in situ, such that the shape of the elongated core can be adjusted by the adjustment of the length of the first cross-sectional distance, such that the length of the first cross-sectional distance can be increased relative to the length of the second cross-sectional distance.
  • the shape of the elongated core can be adjusted by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance while the length of a circumference of a cross-section of the elongated core, in a plane parallel to the coronal plane of the patient remains constant.
  • the shape of a cross-section of the elongated core can be adjusted to an elongated shape by an increase of the length of the first cross-sectional distance relative to the length of the second cross-sectional distance.
  • the elongated core comprises a lower portion configured to, directly or indirectly, engage the stomach of the patient in a region of the angle of his, such that the function of the elongated core is supported by tissue of the stomach in the region of the angle of his.
  • the elongated core comprises an upper portion configured to, directly or indirectly, engage the thoracic diaphragm of the patient, and the upper portion comprises at least one curvature.
  • the elongated core in any of the embodiments herein may be configured to be at least partially invaginated by the stomach wall.
  • the elongated core is configured to be at least partially invaginated by the stomach wall of the fundus.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient.
  • the curve may be configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 1/3 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device is configured to encircle at least 1/2 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device comprises a C-shaped cross-section in a plane parallel to the transverse plane of the patient, and the C-shaped cross-section is configured to partially enclose the esophagus of the patient, in another embodiment, the movement restriction device is configured to encircle at least 2/3 of the esophagus in a plane parallel to the transverse plane of the patient.
  • the second length variability function may in any of the embodiments herein be configured for post-operatively adjusting the length that the core has in its constricting state with more than 5%, or with more than 10%, or with more than 15% or with more than 20%.
  • the apparatus may in any of the embodiments herein comprise at least one electrode for electrically stimulating at least one tissue portion of the patient.
  • the apparatus comprises an elongated core having a length allowing the elongated core to at least partly encircle the esophagus of the patient.
  • the elongated core comprises a first length variability function allowing the core to be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing; and a protruding portion configured to protrude from the first length variability function in a direction more parallel than perpendicular to the cranial -caudal axis of the patient, in a substantially cranial direction, when the elongated core is implanted.
  • the protruding portion is configured to protrude a distance of at least 10mm in a substantially cranial direction from a plane extending perpendicularly from the cranial -caudal axis of the patient and comprising the center of gravity of the elongated core, and the protruding portion is configured to directly or indirectly engage the thoracic diaphragm of the patient for restricting the movement of the cardia of the patient.
  • the protruding portion may protrude a distance of at least 20mm in a substantially cranial direction from a plane extending perpendicularly from the cranial -caudal axis of the patient and comprising the center of gravity of the elongated core.
  • the protruding portion may be configured to protrude in a substantially cranial direction from a plane extending perpendicularly from the cranial -caudal axis of the patient and comprising the center of gravity of the elongated core, a distance such that an upper portion of the protruding portion is placed at least 5mm above the cardiac sphincter.
  • the protruding portion may be configured to protrude in a substantially cranial direction from a plane extending perpendicularly from the cranial -caudal axis of the patient and comprising the center of gravity of the elongated core, a distance such that an upper portion of the protruding portion is placed at least 10mm above the cardiac sphincter.
  • the protruding portion may be configured to protrude in a substantially cranial direction from a plane extending perpendicularly from the cranial -caudal axis of the patient and comprising the center of gravity of the elongated core, a distance such that an upper portion of the protruding portion is placed at least 15mm above the cardiac sphincter.
  • the elongated core may have a first cross-sectional area in a first plane extending perpendicularly from the cranial-caudal axis of the patient, and the protruding portion may have a second cross-sectional area in a second plane parallel to the first plane, and the first cross-sectional area may be more than 1,5 times the size of the second cross-sectional area.
  • the second cross-sectional area is an average cross-sectional area of the protruding portion.
  • the protruding portion has a third cross-sectional area in a third plane parallel to the first plane, and the second plane is positioned between the first and third planes, and the third cross-sectional area is more than 1,5 times the size of the second cross-sectional area.
  • the apparatus further comprises a second elongated core having a length allowing the second elongated core to at least partly encircle the esophagus of the patient.
  • the protruding portion may connect the first elongated core to the second elongated core.
  • the elongated core comprises a lower portion configured to, directly or indirectly, engage the stomach of the patient in a region of the angle of his, such that the function of the elongated core is supported by tissue of the stomach in the region of the angle of his.
  • the protruding portion comprises an upper portion configured to, directly or indirectly, engage the thoracic diaphragm of the patient, and the upper portion comprises at least one curvature.
  • At least one of the first elongated core, the second elongate core and the protruding portion may be configured to be at least partially invaginated by the stomach wall.
  • the protruding portion is adjustable in situ, such that the length that the protruding portion protrudes from the plane extending perpendicularly from the cranial -caudal axis of the patient and comprising the center of gravity of the elongated core can be adjusted.
  • the protruding portion may be hydraulically adjustable and may further comprises a conduit configured to connect the hydraulically adjustable protruding portion to an implantable injection port.
  • At least one of the protruding portion and the elongated core comprises an injection port, such that the hydraulically adjustable protruding portion can be adjusted by the injection or withdrawal of a hydraulic fluid into the injection port.
  • the protruding portion comprises a bellows, and injection or withdrawal of a hydraulic fluid into the injection port adjusts a length of the bellows.
  • the protruding portion comprises a wall enclosing a hydraulic adjustment chamber, and the thickness of the wall varies affecting the alteration of the shape of the protruding portion as fluid is injected into or withdrawn from the protruding portion.
  • the shape of the protruding portion may be altered by the thinner portion of the wall enclosing the hydraulic adjustment chamber being deformed more than thicker portions of the wall enclosing the hydraulic adjustment chamber.
  • the protruding portion is mechanically adjustable and the apparatus may comprise a mechanical operation device for mechanically adjusting the protruding portion.
  • the movement restriction device comprises a transferring element configured to transfer at least one of: electrical energy, and mechanical force to the mechanically adjustable protruding portion.
  • the transferring element comprises at least one of an electrical lead, a shaft for transferring rotating force, and a shaft for transferring linear force.
  • the mechanical operation device may comprise an electrical motor, and may comprises a transmission configured to transform a rotating force generated by the electrical motor into a linear force for adjusting the length of the protruding portion.
  • a portion of the protruding portion comprises a bellows, and wherein the operation of the mechanical operation device adjusts a length of the bellows.
  • the protruding portion is electrically adjustable, and the apparatus may comprise at least one material configured to alter shape when exposed to an electrical current or an electrical voltage.
  • the material may be at least one electroactive polymer, which could be at least one electroactive polymer selected from a list consisting of: ferroelectric polymers, electrostrictive graft polymers, electrostrictive paper, piezoelectric polymers and liquid crystal elastomers.
  • the length of the protruding portion may be adjustable in situ more than 1,2 times, or more than 1,3 times, or more than 1,5 times.
  • the elongated core comprises a curved cross-section in a plane parallel to the transverse plane of the patient, and wherein the curve is configured to partially enclose the esophagus of the patient.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient.
  • the curve may be configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 1/3 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device is configured to encircle at least 1/2 of the esophagus in a plane parallel to the transverse plane of the patient, in another embodiment, the movement restriction device comprises a C-shaped cross-section in a plane parallel to the transverse plane of the patient, and the C-shaped cross-section is configured to partially enclose the esophagus of the patient, in another embodiment, the movement restriction device is configured to encircle at least 2/3 of the esophagus in a plane parallel to the transverse plane of the patient.
  • a cross-section of the elongated core in a plane parallel to the transverse plane of the patient may comprise a closed curve configured to enclose the esophagus of the patient.
  • the first length variability function comprises an attractor for resiliency attracting adjacent portions of the elongated core to one another.
  • the attractor may comprise an elastic element or at least two mutually attracting magnets.
  • the apparatus may further comprise a link connecting a first and a second one of said at least two magnets to each other.
  • the elongated core is configured to exert an encircling pressure on the esophagus in the constricting state.
  • the apparatus comprises two end portions configured to be coupled to each other to form a closed ring around the esophagus.
  • the end portions may be configured to be releasably attached to each other and may comprise a respective interlockable attacher.
  • the elongated core may comprise a plurality of bodies configured to be arranged in an annular array around the esophagus.
  • the elongated core further comprises a plurality of links, each of which extending between a respective pair of bodies arranged adjacent to each other.
  • the elongated core is configured to be implanted such that the protruding portion is arranged at the fundus side of the esophagus.
  • the apparatus may further comprise a second length variability function configured for post- operatively adjusting the length that the elongated core has in its constricting state with more than 5%, or with more than 10%, or with more than 15% or with more than 20%.
  • the apparatus may in any of the embodiments herein comprise at least one electrode for electrically stimulating at least one tissue portion of the patient.
  • a method for treating reflux disease of a human patient by implanting a movement restriction device is further provided.
  • the movement restriction device is arranged to restrict movement of the cardia of the patient’s stomach towards the diaphragm to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the movement restriction device comprises a curved inner surface configured to face the curved outer surface of the esophagus.
  • the method comprising positioning and fixating the movement restriction device such that the curved inner surface encircles at least 1/3 of the esophagus in a plane extending perpendicular to the cranial - caudal axis, and the center of mass of the movement restriction device is placed in a plane extending perpendicular to the cranial - caudal axis, and wherein the shortest distance from a point on the plane to the angle of His exceeds 20mm.
  • the method comprises the step of attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position below the center of mass of the movement restriction device, such that the movement restriction device is supported by the attachment of the fundus to the esophagus.
  • the step of attaching the fundus of the stomach of the patient to the esophagus of the patient in a first position may comprise attaching the fundus of the stomach of the patient to the esophagus of the patient at a distance from the angle of His exceeding 5mm.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating the movement restriction device such that the upper most point of the movement restriction device is placed in a second plane extending perpendicular to the cranial - caudal axis, and the shortest distance from a point on the second plane to the angle of His exceeds 40mm.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating the movement restriction device such that the upper most point of the movement restriction device is placed in a second plane extending perpendicular to the cranial - caudal axis, and wherein the shortest distance from a point on the second plane to the angle of His exceeds 50mm.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating the movement restriction device such that the lower most point of the movement restriction device is placed in a third plane extending perpendicular to the cranial - caudal axis, and wherein the shortest distance from a point on the third plane to the angle of His exceeds 10mm.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating the movement restriction device such that the lower most point of the movement restriction device is placed in a third plane extending perpendicular to the cranial - caudal axis, and wherein the shortest distance from a point on the third plane to the angle of His exceeds 20mm.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating the movement restriction device such that the upper most point of the movement restriction device is placed in a second plane extending perpendicular to the cranial - caudal axis, and wherein the shortest distance from a point on the second plane to an upper-most point of the cardia exceeds 5mm.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating the movement restriction device such that the upper most point of the movement restriction device is placed in a second plane extending perpendicular to the cranial - caudal axis, and wherein the shortest distance from a point on the second plane to an upper-most point of the cardia exceeds 10mm.
  • the step of positioning and fixating the movement restriction device comprises positioning the center of mass of the movement restriction device in the second plane extending perpendicular to the cranial - caudal direction, and wherein the shortest distance from a point on the second plane to an upper-most point of the cardia exceeds 5mm.
  • the step of positioning and fixating the movement restriction device comprises positioning the center of mass of the movement restriction device in the second plane extending perpendicular to the cranial - caudal direction, and wherein the shortest distance from a point on the second plane to an upper-most point of the cardia exceeds 10mm.
  • the step of positioning and fixating the movement restriction device comprises positioning a movement restriction device encircling at least 1/2 of the esophagus in a plane extending perpendicular to the cranial - caudal direction.
  • the step of positioning and fixating the movement restriction device comprises positioning a movement restriction device encircling at least 2/3 of the esophagus in a plane extending perpendicular to the cranial - caudal direction.
  • the step of positioning and fixating the movement restriction device comprises positioning a movement restriction device encircling the esophagus in a plane extending perpendicular to the cranial - caudal direction.
  • the curved inner surface configured to face the curved outer surface of the esophagus comprises a radius of curvature corresponding to or exceeding the radius of curvature of the esophagus, such that the curved inner surface comprises a radius of curvature corresponding to or exceeding the radius of curvature of the esophagus.
  • the step of positioning and fixating the movement restriction device comprises positioning a movement restriction device comprising an electrode arrangement configured to electrically stimulate muscle tissue of the portion of the fundus and/or the serosa to improve the conditions for long term implantation of the movement restriction device.
  • the method further comprises implanting an implantable energy source configured to provide the electrode with electrical power.
  • the step of positioning and fixating the movement restriction device comprises positioning a movement restriction device having a constricting state for hindering fluid from passing from the stomach into the esophagus and an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the step of positioning the movement restriction device comprises positioning a movement restriction device configured to exert an encircling pressure on the esophagus in the constricting state.
  • the step of positioning and fixating the movement restriction device comprises positioning a movement restriction device comprising at least one attractor for resiliently attracting adjacent portions of the movement restriction device to generate the encircling pressure.
  • the attractor may comprise an elastic element or at least two mutually attracting magnets.
  • the apparatus may further comprise a link connecting a first and a second one of said at least two magnets to each other.
  • the step of positioning and fixating the movement restriction device comprises positioning and fixating a movement restriction device having an adjustable volume.
  • Migration of the movement restriction device is generally undesirable as it may decrease the effectiveness of the treatment of reflux disease in a human patient receiving the movement restriction device.
  • an apparatus for treating reflux disease of a human patient comprising an implantable movement restriction device configured to be at least partly invaginated by the stomach wall of the patient for restricting the movement of the cardia of the patient towards the thoracic diaphragm.
  • the implantable movement restriction device is comprising a surface friction reducing coating covering at least a part of the surface of the implantable movement restriction device.
  • the surface friction reducing coating is configured to reduce the friction between the implantable movement restriction device and the tissue of the stomach wall by which the implantable movement restriction device is at least partially invaginated.
  • a surface friction reducing coating covering at least a part of the surface of the implantable movement restriction device advantageously prevents or reduces the risk of migration of the implantable movement restriction device.
  • the surface friction reducing coating maximizes contact with surrounding tissue, and it provides lubrication for the movement restriction device.
  • the surface friction reducing coating is covering at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, such as at least 95% of the surface of the movement restriction device.
  • the surface friction reducing coating is covering the entire surface of the movement restriction device. A higher degree of surface coverage is associated with a higher reduction of the risk of migration of the implantable movement restriction device.
  • the surface friction reducing coating is selected from natural polymers; polysaccharide coatings, oils, hydrogels, and lubricating jellies.
  • the surface friction reducing coating comprises one or more natural polymers dissolved in water.
  • Preferred natural polymers are selected from polysaccharides, such as native and modified celluloses, native and modified starches, xanthan gum, guar gum, carrageenan, alginate, pectin, and combinations thereof.
  • a preferred polymer is methylcellulose, such as hydroxypropyl methylcellulose (HPMC) and carboxymethylcellulose.
  • Another preferred polymer is ethylcellulose, such as hydroxyethylcellulose.
  • An example of a useful hydrogel is a polypropylene fumarate-co-ethylene glycol) hydrogel.
  • the surface friction reducing coating is selected from racine oil, mineral oil, glycerin, and polyethylene glycol (PEG).
  • PEG polyethylene glycol
  • a preferred agent is PEG. It is further preferred to use PEG with larger size (> 5 kDa) as it remains in tissues for several days before being cleared.
  • the surface friction reducing coating may furthermore comprise an active agent selected from bactericides, antibiotics, bacteriostatics, analgesics and anesthetics.
  • antibiotics are naturally occurring or synthetic substances that are used to kill or inhibit the growth of bacteria.
  • antibiotics include penicillin (e.g. penicillin and amoxicillin), cephalosporins (e.g. cephalexin and cefuroxime), macrolides (e.g. erythromycin and azithromycin), tetracyclines (e.g. tetracycline and doxycycline), quinolones (e.g. ciprofloxacin and levofloxacin), sulfonamides (e.g.
  • bacteriophages examples include bacteriophages.
  • antiinflammatory analgesics e.g. acetaminophen, aspirin, COX inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen
  • opioids e.g. codeine, fentanyl, hydrocodone, meperidine, methadone, naloxone, naltrexone and oxycodone.
  • anesthetics which are useful in the surface friction reducing coating include local anesthetics which can be either ester- or amide-based.
  • ester local anesthetics include procaine, amethocaine, cocaine, benzocaine, tetracaine.
  • amide local anesthetics include lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine and etidocaine.
  • a preferred anesthetic is lidocaine, preferably in a concentration of 1-10 % (w/v), such as 1-5% (w/v), such as 1-3% (w/v), such as about 2% (w/v).
  • the surface friction reducing coating provides antiseptic properties to the movement restriction device.
  • the surface friction reducing coating may also contain pH-adjusting compounds, including weak acids, weak bases and buffers.
  • the surface friction reducing coating provides softening of adjacent tissues. This may further prevents or reduce the risk of migration of the implantable movement restriction device.
  • the surface friction reducing coating is a viscous medium.
  • a viscous coating composition is a type of liquid or semi-solid material that is used to create a protective layer or film on a surface. This type of coating is characterized by its thick, sticky consistency, which allows it to adhere to the surface and form a durable, long-lasting layer.
  • viscous coating compositions available, each with its own unique properties and characteristics.
  • the viscous medium is a viscous aqueous medium, such as a viscous aqueous liquid, such as a viscous aqueous solution.
  • the viscous aqueous medium may be a viscoelastic medium.
  • a preferred viscoelastic medium is a gel.
  • the viscous medium may also be a viscous liquid.
  • Viscosity can be e.g. determined at 20°C using a shear rate controlled rheometer (Model 302, Anton Paar, Germany), using a parallel plate geometry (plate diameter 50 mm, gap 100 pm). In this setup, the viscosity of water is approximately constant at 1 mPa s, at shear rates between 0 - 100 s-1. For avoidance of doubt, viscous media as defined herein are considerably more viscous than water. Viscous media as defined herein typically exhibit a viscosity of at least 10 mPa s, such as at least 50 mPa s at shear rates between 0 - 100 s-1, such as at 50 s-1.
  • viscous media as defined herein exhibit a viscosity of at least 100 mPa s, such as at least 200 mPa s at shear rates between 0 - 100 s-1, such as at 50 s-1.
  • the specific values above are relevant for this specific setup, but the skilled person can easily determine corresponding values for viscosity in other experimental setups.
  • the surface friction reducing coating has a higher viscosity than water.
  • the surface friction reducing coating may comprise preservatives.
  • preservatives include antimicrobial preservatives, e.g. sorbic acid, parabens and lactic acid.
  • antimicrobial preservatives e.g. sorbic acid, parabens and lactic acid.
  • a preferred type of preservatives is parabens, e.g. methylparaben and propylparaben.
  • the surface friction reducing coating is configured to remain in a pouch for housing the implantable movement restriction device for a time period exceeding 7 days, preferably exceeding 14 days, such as exceeding 21 days or 28 days.
  • the surface friction reducing coating are: (1) Xylocaine jelly, containing 0.1 - 10% (w/v) xylocaine (lidocaine hydrochloride).
  • the composition also contains methylparaben, propylparaben, hydroxypropyl methylcellulose, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0-7.0.
  • Xylocaine viscous composition containing 0.1 - 10% (w/v) xylocaine (lidocaine hydrochloride).
  • the composition also contains carboxymethylcellulose sodium, methylparaben, propylparaben, purified water and saccharin sodium.
  • Lubricating glycerin jelly containing water, PEG, glycerin, carbomer, sodium hydroxide, methylparaben, propylparaben.
  • Lidocaine jelly containing 0.1 - 10% (w/v) lidocaine hydrochloride.
  • the composition also contains glycerol, hydrochloric acid, hydroxyethylcellulose, sodium hydroxide, and water.
  • the implantable movement restriction device has a size such that the implantable movement restriction device can be fully invaginated by the fundus wall of the patient as set out herein.
  • the implantable movement restriction device has a size of less than 200 cm2, preferably less than 100 cm2, and more preferably less than 50 cm2.
  • the movement restriction device is elongated.
  • a first cross-sectional distance has a first length
  • a second cross-sectional distance has a second length, wherein the first length is more than 1,2 times the second length, preferably more than 1,5 times the second length and even more preferably more than 2 times the second length.
  • implantable movement restriction device (100) comprises at least one circular cross-section.
  • the implantable movement restriction device (100) comprises a first, second and third cross-section in planes spaced apart and parallel to each other, wherein the first and third cross-sections have the same area, and the second crosssection is located between the first and third cross-section and have a smaller area.
  • the implantable movement restriction device comprises at least two parts, or at least three parts, or at least 4 parts.
  • the at least two parts are configured to be assembled to form the implantable movement restriction device.
  • the at least two parts are configured to be connected to each other to form the implantable movement restriction device.
  • the movement restriction device comprises a curved cross-section in a plane parallel to the transverse plane of the patient, and wherein the curve is configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 1/3 of the esophagus in a plane parallel to the transverse plane of the patient, and preferably at least 1/2 of the esophagus in a plane parallel to the transverse plane of the patient.
  • the movement restriction device comprises a C-shaped cross-section in a plane parallel to the transverse plane of the patient, and wherein the C-shaped crosssection is configured to partially enclose the esophagus of the patient.
  • the movement restriction device is configured to encircle at least 2/3 of the esophagus in a plane parallel to the transverse plane of the patient.
  • a cross-section of the movement restriction device in a plane parallel to the transverse plane of the patient comprises a closed curve configured to enclose the esophagus of the patient.
  • the implantable movement restriction device (100) comprises at least one circular cross-section.
  • a method for treating reflux disease of a human patient by implanting a movement restriction device (100).
  • the method comprises: at least partially invaginating the movement restriction device in the stomach of the patient such that the movement restriction device restricts movement of the cardia (22) of the patient’s stomach (10) towards the thoracic diaphragm (30) to hinder the cardia from sliding through the diaphragm opening (32) into the patient’s thorax, wherein the surface of the movement restriction device is at least partially covered by a surface friction reducing coating.
  • a friction-reducing composition for use in the method as defined herein as a surface friction reducing coating.
  • a composition selected from natural polymers, polysaccharide coatings, oils, hydrogels, and lubricating jellies as a surface friction reducing coating of at least part of the surface of an implantable movement restriction device for treating reflux disease of a human patient, wherein the movement restriction device (100) is configured to be at least partially invaginated by a stomach wall of a patient and arranged to restrict movement of the cardia (22) of a patient’s stomach (10) towards the diaphragm (30) to hinder the cardia from sliding through the diaphragm opening (32) into the patient’s thorax.
  • the surface friction reducing coating maximizes contact with surrounding tissue, and it provides lubrication for the movement restriction device.
  • the method comprises the step of applying the surface friction reducing coating onto the movement restriction device prior to implantation in the body of the patient. This implies that the coating is applied ex vivo. In other embodiments, the method comprises the step applying the surface friction reducing coating in situ between the movement restriction device and tissue of the stomach wall of the patient.
  • the method comprises the steps of:
  • the step of at least partially invaginating the movement restriction device in the stomach of the patient comprises fully invaginating the movement restriction device in the stomach of the patient.
  • the method is a laparoscopic surgical method, and the method further comprises the step of introducing the movement restriction device into the body of the patient through a laparoscopic trocar after the surface friction reducing coating has been applied.
  • the method is a laparoscopic surgical method
  • the step of applying the surface friction reducing coating in situ between the movement restriction device and tissue of the stomach wall of the patient comprises applying the surface friction reducing coating in situ using a laparoscopic instrument inserted into the body of the patient though a laparoscopic trocar.
  • the method is a gastroscopic method, and the method further comprises the step of introducing the movement restriction device into the body of the patient through the esophagus of the patient after the surface friction reducing coating has been applied.
  • the method is a gastroscopic method
  • the step of applying the surface friction reducing coating in situ between the movement restriction device and tissue of the stomach wall of the patient comprises applying the surface friction reducing coating in situ using a gastroscopic instrument inserted into the body of the patient though the esophagus.
  • the surface friction reducing coating is covering at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, such as at least 95% of the surface of the movement restriction device.
  • the surface friction reducing coating is covering the entire surface of the movement restriction device. A higher degree of surface coverage is associated with a higher reduction of the risk of migration of the implantable movement restriction device.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising a surface friction reducing coating covering the entire surface of the movement restriction device.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising a surface friction reducing coating selected from natural polymers, polysaccharide coatings, oils, hydrogels, and lubricating jellies.
  • the surface friction reducing coating comprises one or more natural polymers dissolved in water.
  • Preferred natural polymers are selected from polysaccharides, such as native and modified celluloses, native and modified starches, xanthan gum, guar gum, carrageenan, alginate, pectin, and combinations thereof.
  • a preferred polymer is methylcellulose, such as hydroxypropyl methylcellulose (HPMC) and carboxymethylcellulose.
  • Another preferred polymer is ethylcellulose, such as hydroxyethylcellulose.
  • a useful hydrogel is a polypropylene fumarate-co-ethylene glycol) hydrogel.
  • the surface friction reducing coating is selected from racine oil, mineral oil, glycerin, and polyethylene glycol (PEG).
  • PEG polyethylene glycol
  • a preferred agent is PEG. It is further preferred to use PEG with larger size (> 5 kDa) as it remains in tissues for several days before being cleared.
  • the surface friction reducing coating may furthermore comprise an active agent selected from bactericides, antibiotics, bacteriostatics, analgesics and anesthetics.
  • antibiotics are naturally occurring or synthetic substances that are used to kill or inhibit the growth of bacteria.
  • antibiotics include penicillin (e.g. penicillin and amoxicillin), cephalosporins (e.g. cephalexin and cefuroxime), macrolides (e.g. erythromycin and azithromycin), tetracyclines (e.g. tetracycline and doxycycline), quinolones (e.g. ciprofloxacin and levofloxacin), sulfonamides (e.g.
  • bacteriophages examples include bacteriophages.
  • antiinflammatory analgesics e.g. acetaminophen, aspirin, COX inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen
  • opioids e.g. codeine, fentanyl, hydrocodone, meperidine, methadone, naloxone, naltrexone and oxycodone.
  • anesthetics which are useful in the surface friction reducing coating include local anesthetics which can be either ester- or amide-based.
  • ester local anesthetics include procaine, amethocaine, cocaine, benzocaine, tetracaine.
  • amide local anesthetics include lidocaine, prilocaine, bupivacaine, levobupivacaine, ropivacaine, mepivacaine, dibucaine and etidocaine.
  • a preferred anesthetic is lidocaine, preferably in a concentration of 1-10 % (w/v), such as 1-5% (w/v), such as 1-3% (w/v), such as about 2% (w/v).
  • the surface friction reducing coating provides antiseptic properties to the movement restriction device.
  • the surface friction reducing coating may also contain pH-adjusting compounds, including weak acids, weak bases and buffers.
  • the surface friction reducing coating provides softening of adjacent tissues. This may further prevents or reduce the risk of migration of the implantable movement restriction device.
  • the surface friction reducing coating is a viscous medium.
  • a viscous coating composition is a type of liquid or semi-solid material that is used to create a protective layer or film on a surface. This type of coating is characterized by its thick, sticky consistency, which allows it to adhere to the surface and form a durable, long-lasting layer.
  • the viscous medium is a viscous aqueous medium, such as a viscous aqueous liquid, such as a viscous aqueous solution.
  • the viscous aqueous medium may be a viscoelastic medium.
  • a preferred viscoelastic medium is a gel.
  • the viscous medium may also be a viscous liquid.
  • Viscosity can be e.g. determined at 20°C using a shear rate controlled rheometer (Model 302, Anton Paar, Germany), using a parallel plate geometry (plate diameter 50 mm, gap 100 pm). In this setup, the viscosity of water is approximately constant at 1 mPa s, at shear rates between 0 - 100 s-1. For avoidance of doubt, viscous media as defined herein are considerably more viscous than water. Viscous media as defined herein typically exhibit a viscosity of at least 10 mPa s, such as at least 50 mPa s at shear rates between 0 - 100 s-1, such as at 50 s-1.
  • viscous media as defined herein exhibit a viscosity of at least 100 mPa s, such as at least 200 mPa s at shear rates between 0 - 100 s-1, such as at 50 s-1.
  • the specific values above are relevant for this specific setup, but the skilled person can easily determine corresponding values for viscosity in other experimental setups.
  • the surface friction reducing coating has a higher viscosity than water.
  • the surface friction reducing coating may comprise preservatives.
  • preservatives include antimicrobial preservatives, e.g. sorbic acid, parabens and lactic acid.
  • antimicrobial preservatives e.g. sorbic acid, parabens and lactic acid.
  • a preferred type of preservatives is parabens, e.g. methylparaben and propylparaben.
  • the surface friction reducing coating is configured to remain in a pouch for housing the implantable movement restriction device for a time period exceeding 7 days, preferably exceeding 14 days, such as exceeding 21 days or 28 days.
  • Xylocaine jelly containing 0.1 - 10% (w/v) xylocaine (lidocaine hydrochloride).
  • the composition also contains methylparaben, propylparaben, hydroxypropyl methylcellulose, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0-7.0.
  • Xylocaine viscous composition containing 0.1 - 10% (w/v) xylocaine (lidocaine hydrochloride).
  • the composition also contains carboxymethylcellulose sodium, methylparaben, propylparaben, purified water and saccharin sodium.
  • Lubricating glycerin jelly containing water, PEG, glycerin, carbomer, sodium hydroxide, methylparaben, propylparaben.
  • Lidocaine jelly containing 0.1 - 10% (w/v) lidocaine hydrochloride.
  • the composition also contains glycerol, hydrochloric acid, hydroxyethylcellulose, sodium hydroxide, and water.
  • the implantable movement restriction device has a size such that the implantable movement restriction device can be fully invaginated by the fundus wall of the patient as set out herein.
  • the implantable movement restriction device has a size of less than 200 cm2, preferably less than 100 cm2, and more preferably less than 50 cm2.
  • the step of at least partially invaginating a movement restriction device may comprise at least partially invaginating a movement restriction device having a size such that the implantable movement restriction device can be fully invaginated by the fundus wall of the patient.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device having a size of less than 200 cm2, preferably less than 100 cm2, and more preferably less than 50 cm2.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device being elongated and having a first cross-sectional distance having a first length, and a second cross-sectional distance having a second length, and wherein the first length is more than 1,2 times the second length, preferably more than 1,5 times the second length and even more preferably more than 2 times the second length.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising at least one circular cross-section.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising a first, second and third cross-section in planes spaced apart and parallel to each other, wherein the first and third crosssections have the same area, and the second cross-section is located between the first and third crosssection and have a smaller area.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising at least two parts, or at least three parts, or at least 4 parts.
  • the step of at least partially invaginating a movement restriction device comprises assembling at least two parts for forming the implantable movement restriction device.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising a curved cross-section in a plane parallel to the transverse plane of the patient, and wherein the curve is configured to partially enclose the esophagus of the patient.
  • the step of at least partially invaginating a movement restriction device comprises at least partially invaginating a movement restriction device comprising at least one circular cross-section.
  • an apparatus for treating reflux disease of a human patient comprising an implantable movement restriction device and an electrode arrangement.
  • the implantable movement restriction device has a shape and size that allows it to be arranged to rest against a fundus wall portion of the patient’s stomach and to be at least partly invaginated by the fundus wall portion, such that the movement restriction device is implanted at a position between the patient’s diaphragm and a lower portion of the fundus wall, and such that movement of the cardia of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the electrode arrangement is configured to be arranged between the movement restriction device and the fundus wall portion and to engage and electrically stimulate muscle tissue of the fundus wall portion to exercise the muscle tissue to improve the conditions for long term implantation of the movement restriction device.
  • an apparatus for treating reflux disease of a human patient comprising an at least partly ring-shaped implantable movement restriction device and an electrode arrangement.
  • the implantable movement restriction device comprises a first portion configured to be at least partly invaginated by a first wall portion of the patient’s stomach and arranged such that at least a part of the first portion is arranged above the cardiac notch of the patient’s stomach, and such that movement of the cardia towards the diaphragm is restricted to prevent the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the electrode arrangement is configured to be arranged between the movement restriction device and the first wall portion and to electrically stimulate muscle tissue of the first wall portion to exercise the muscle tissue to improve the conditions for long term implantation of the movement restriction device.
  • an apparatus for treating reflux disease of a human patient comprising an elongated core and a tubular cover.
  • the elongated core has a length allowing the core to at least partly encircle the esophagus of the patient, wherein the length is variable to allow the core to be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the tubular cover is configured to encloses at least a part of the core and comprises a plurality of portions adapted to bend relative to each other to allow the core to change between the constricting state and the expanded state, when the cover is at least partly covered by fibrotic tissue, without being substantially hindered or impeded by the presence of said fibrotic tissue.
  • an apparatus for treating reflux disease of a human patient comprising an elongated core having a length allowing the core to at least partly encircle the esophagus of the patient, wherein the length is variable to allow the core to be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the apparatus further comprises an electrode arrangement comprising an electrode element supported by the core and configured to be arranged between the apparatus and the esophagus and to electrically stimulate muscle tissue of the esophagus.
  • an apparatus for treating reflux disease of a human patient comprising a tubular device having a length allowing the tubular device to at least partly encircle the esophagus of the patient, wherein the length is variable to allow the tubular cover to be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the outer surface of the tubular device may comprise a plurality of portions adapted to bend relative to each other to allow the tubular device to change between the constricting state and the expanded state, when the outer surface is at least partly covered by fibrotic tissue, without being substantially hindered or impeded by the presence of said fibrotic tissue.
  • an apparatus for treating reflux disease of a human patient comprising an elongated core having a length allowing the core to at least partly encircle the esophagus of the patient.
  • the length may be variable to allow the core to be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • the elongated core has a size allowing at least a portion of the elongated core to protrude above the cardiac sphincter of the patient, when implanted, such that movement of the cardia towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • an apparatus for treating reflux disease of a human patient which is adapted to at least partly encircle the esophagus (20) of the patient.
  • the apparatus comprises a first implantable portion and a second implantable portion, wherein the first implantable portion has a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach and to be at least partly invaginated by the fundus wall portion, such that the first implantable portion is implanted at a position between the patient’s diaphragm and a lower portion of the fundus wall, and such that movement of the cardia of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the second implantable portion is elongated to at least partly encircle the esophagus and has a variable length for allowing the apparatus be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing.
  • an apparatus for treating reflux disease of a human patient which is adapted to at least partly encircle the esophagus of the patient.
  • the apparatus comprises a movement restriction device, an elongated support device and an electrode arrangement.
  • the movement restriction device has a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach and to be at least partly invaginated by the fundus wall portion, such that the first implantable portion is implanted at a position between the patient’s diaphragm and a lower portion of the fundus wall, and such that movement of the cardia of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the elongated support device is connected to the movement restriction device and configured to at least partly encircle the esophagus.
  • the electrode arrangement comprises an electrode element supported by the support device and configured to electrically stimulate muscle tissue of the esophagus.
  • the support device comprises a rigidity that allows the position of the electrode element relative to the esophagus to be determined mainly by the position and orientation of the movement restriction device.
  • a method for treating reflux disease of a human patient involves implanting a movement restriction device such that the movement restriction device is arranged to restrict movement of the cardia of the patient’s stomach towards the diaphragm to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the method comprises placing the movement restriction device such that a lower portion of the movement restriction device rests against the serosa at the angle of His, and such that an upper portion of the movement restriction device defines a gap between the movement restriction device and the patient’s esophagus, when the lower portion rests against the angle of His.
  • the method further comprises arranging a portion of the fundus of the stomach in the gap and attaching the fundus to the patient’s esophagus to at least partly enclose the movement restriction device by the portion of the fundus.
  • an apparatus for treating reflux disease of a human patient comprising an implantable movement restriction device and an elongated attacher configured to be attached to the movement restriction device and to be at least partly invaginated by a wall portion of the patient’s stomach.
  • the attacher comprises a shape and size allowing it to be invaginated by the wall portion to hinder rotation of the movement restriction device.
  • the attacher is further configured to be invaginated by the wall portion such that the movement restriction device is arranged at a position between the patient’s diaphragm and the wall portion, distant from the patient’s esophagus, to restrict movement of the cardia of the patient’s stomach towards the diaphragm to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • an apparatus for treating reflux disease of a human patient comprising an at least partly ring-shaped implantable movement restriction device configured to be arranged such that at a first, lower portion of the movement restriction device is arranged at the cardia of the patient’s stomach and such that a second, upper portion of the movement restriction device is arranged to abut the diaphragm of the patient, such that movement of the cardia towards the diaphragm is restricted to prevent the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the apparatus is further configured to be arranged to define a gap or spacing between the second, upper portion of the movement restriction device and the outside of the esophagus when the apparatus is implanted.
  • the apparatus may be formed of the movement restriction device as disclosed herein, or at least comprise such a movement restriction device.
  • a method of treating reflux disease in a human patient involves implanting an apparatus comprising a movement restriction device and an elongated support device, such that the support device at least partly encircles the esophagus of the patient and such that the movement restriction device is at arranged on the fundus side of the esophagus to restrict the movement of the cardia in relation to the diaphragm to hinder the cardia to from sliding through the diaphragm opening into the patient’s thorax.
  • the method comprises the steps of introducing the apparatus into the abdominal cavity, placing the apparatus such that the movement restriction device rests against the outside of the stomach’s fundus, wrapping a portion of the fundus around at least a part of the movement restriction device, affixing the fundus to the esophagus such that the movement restriction device is arranged at a position between the diaphragm and the cardiac sphincter, and such that a part of the fundus is arranged between the movement restriction device and the esophagus and arranging the support device to at least partly encircle the esophagus.
  • the movement restriction device and the second portion form a ring-shaped body extending through the pouch to at least partly encircle the esophagus.
  • a method for affixing a fundus portion of the stomach of a human patient to the patient’s esophagus wherein the fundus portion extends from the angle of His and in a direction away from the esophagus.
  • the method comprises folding the fundus portion towards the esophagus such that the fundus portion rests against the esophagus, from the angle of His and upwards along the esophagus, and affixing the fundus portion to the esophagus by means of fasteners arranged along a first line and a second line.
  • the first line and the second line extend along the esophagus and are arranged such that a distance between the first line and the second line increases with an increasing distance from the angle of His.
  • an apparatus for treating reflux disease in a human patient comprises an electrode arrangement for electrically stimulating the patient’s muscle tissue to exercise the muscle tissue to improve the conditions for long term implantation of the apparatus, as outlined above.
  • the apparatus further comprises an implantable energy source configured to provide the electrode arrangement with electrical power, a controller operably connected to the electrode arrangement for controlling the electrical stimulation of the muscle tissue.
  • an apparatus for treating reflux disease of a human patient comprises an electrode arrangement, an implantable energy source configured to provide the apparatus with electrical power, an external energy source configured be arranged outside of the patient’s body and configured to provide energy to the implantable energy source, and an implantable charger configured to be electrically connected to the implantable energy source and enable charging of the implantable energy source by the external energy source.
  • an apparatus for treating reflux disease of a human patient comprising: an implantable movement restriction device having a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach (10), such that the movement restriction device is implanted at a position between the patient’s diaphragm (30) and a portion of the fundus wall, and such that movement of the cardia (22) of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax, wherein the implantable movement restriction device comprises an outer surface configured to rest against the stomach wall portion, and wherein an average surface roughness measured on the outer surface is no more than 0.5 pm.
  • an apparatus for treating reflux disease of a human patient comprising: an implantable movement restriction device having a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach, such that the movement restriction device is implanted at a position between the patient’s diaphragm and a portion of the fundus wall, and such that movement of the cardia of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax, wherein the implantable movement restriction device comprises an outer surface configured to rest against the stomach wall portion, and wherein an indentation hardness on the Shore A scale measured on the outer surface is at least 50.
  • an apparatus for treating reflux disease of a human patient comprising an implantable movement restriction device having a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach, such that the movement restriction device is implanted at a position between the patient’s diaphragm and a portion of the fundus wall, and such that movement of the cardia of the patient’s stomach towards the diaphragm is restricted to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax
  • the implantable movement restriction device comprises a plurality of segments, wherein the plurality of segments are comprised of a core part and a plurality of outer parts, and wherein the core part has an average density of above 1000 kg/m3
  • an apparatus for treating reflux disease of a human patient when comprises an electrode arrangement, and a controller configured to be operably connected to the electrode arrangement for controlling the electrical stimulation of the muscle tissue.
  • the controller comprises an implantable communicator for transmitting and/or receiving a signal to/from the outside of the patient’s body.
  • the electrode arrangement may be arranged on an outer surface of the movement restriction device.
  • the electrode arrangements may comprise a plurality of electrode elements, wherein each of the electrode elements is configured to engage and electrically stimulate the muscle tissue.
  • the electrode arrangement may further comprise a coiled wire for increasing a contact surface between the electrode arrangement and the muscle tissue and for allowing the electrode arrangement to follow contraction and relaxation of the muscle tissue.
  • the electrode arrangement may comprise a bare electrode portion configured to form a metal-tissue interface with the muscle tissue so as to allow faradaic charge transfer to the be predominant charge transfer mechanism over the interface.
  • the electrode arrangement may comprise an electrode portion that is at least partly covered by a dielectric material configured to form a dielectric-tissue interface with the muscle tissue so as to allowing a faradaic portion of the charge transfer mechanism over the interface to be reduced.
  • the electrode arrangement may be configured to be arranged to electrically stimulate the cardiac sphincter to cause the cardiac sphincter to contract.
  • the electrode arrangement may comprise at least two electrode elements configured to be arranged on opposing sides of the cardiac sphincter.
  • the apparatus may comprise a holder configured to support the at least two electrode elements at the opposing sides of the cardiac sphincter.
  • a volume of the movement restriction device may be non- adjustable after implantation.
  • the volume of the movement restriction device may be adjustable after implantation.
  • the volume may be adjustable invasively or non-invasively.
  • the movement restriction device comprises an injection port for allowing a fluid to be injected or extracted from the inside of the movement restriction device so as to vary the volume of the movement restriction device after implantation.
  • the movement restriction device may comprise a biocompatible outer surface configured to rest against the fundus wall portion.
  • the movement restriction device may be substantially spherical or egg-shaped.
  • the movement restriction device may have a portion configured to be arranged to point away from the esophagus when implanted.
  • a lower portion of the movement restriction device may be wider that an upper portion.
  • the movement restriction device may be configured to be invaginated when placed on the outside of the fundus wall portion. In another embodiment, the movement restriction device may be configured to be invaginated when placed on the inside of the fundus wall portion.
  • the movement restriction device may be configured to be introduced in the patient’s body by means of a gastroscope or an intraluminal instrument.
  • the movement restriction device may for example be configured to change its shape to allow it to pass through a trocar during insertion into the patient’s body.
  • the movement restriction device may be formed of at least two distinct and separable parts configured to be assembled into the movement restriction device after insertion in the patient’s body.
  • a minimum width of the movement restriction device may be 20 mm or larger, such as 30 mm or larger, such as 40 mm or larger, such as 50 mm or larger.
  • the movement restriction device may comprise a first and a second portion, wherein the first and second portions are configured to be arranged on opposite sides of the cardia.
  • the movement restriction device may be configured to be arranged such that a gap is formed between the second portion of the movement restriction device and the esophagus.
  • the second portion of the movement restriction device may be configured to be at least partly invaginated by a second wall portion of the stomach.
  • the movement restriction device may be configured to be arranged such that a portion of the first wall portion is arranged between the first portion of the movement restriction device and the esophagus.
  • the movement restriction device may be configured to be at least partly invaginated by the first wall portion along at least half of the toroidal length of the movement restriction device.
  • the movement restriction device may be configured to be invaginated when placed on the outside of the stomach wall.
  • the movement restriction device may comprise two end portions configured to be coupled to each other to form a closed ring.
  • the end portions may be configured to be releasably attached to each other.
  • a poloidal circumference of the movement restriction device may be larger for the first portion and for the second portion.
  • a minimum width of the first portion of the movement restriction device is 20 mm or larger, such as 30 mm or larger, such as 40 mm or larger, such as 50 mm or larger.
  • the width may be defined as a height measured along a normal to the plane in which the circumference extends.
  • the movement restriction device may have a shape conforming to a torus.
  • the movement restriction device may have C-shaped cross section.
  • an upper portion of the movement restriction device may comprise a recess defined in the outer surface of the movement restriction device.
  • a lower portion of the movement restriction device may comprise a curved outer surface, which may be arranged to face the esophagus.
  • the curved outer surface may comprise a radius of curvature corresponding to or exceeding the radius of curvature of the esophagus.
  • an elongated support protruding from the movement restriction device, may be at least partly invaginated in the fundus before the fundus is attached to the esophagus.
  • the support may be oriented along the esophagus.
  • the core may be configured to allow a transition from the constricting state into the expanded state caused by the food passing through esophagus.
  • the core may be configured to exert an encircling pressure on the esophagus in the constricting state.
  • the apparatus may further comprise an attractor for resiliently attracting adjacent portions of the core to one another to generate the encircling pressure.
  • the attractor may comprise an elastic element, and/or at least two mutually attracting magnets.
  • the apparatus may comprise a link connecting a first and a second one of said at least two magnets to each other. The link may be configured to extend into at least one of said magnets in response to said magnets moving towards each other.
  • the core may comprise two end portions configured to be coupled to each other to form a closed ring around the esophagus.
  • the end portions may be configured to be releasably attached to each other and may comprise a respective interlockable attacher.
  • the core may comprise a plurality of core elements configured to be arranged in an annular array around the esophagus.
  • the core may further comprise a plurality of links, wherein each link may extend between a respective pair of core elements arranged adjacent to each other.
  • the links may be configured to allow the respective core elements to move towards and away from each other, and may be configured to extend into at least one of the core elements of the respective pair of core elements as the core elements move towards each other.
  • the cover may comprise an array of tubular segments.
  • the cover may comprise a biocompatible outer surface for long-term implantation.
  • the cover may for example be configured to rest against an outer surface of the esophagus and may further comprise a surface for promoting tissue growth.
  • the cover may for example be formed of a polymer material, such as silicone.
  • the cover may be formed of or comprise a carbon-based material, such as carbon fiber material.
  • the cover may be formed of a material having a thickness of 0.1-10 mm, such as 1-5 mm.
  • the cover may comprise at least one predefined fold along which the cover is allowed to fold in response to the core varying its length.
  • the cover may in some examples comprise lowered and elevated portions allowing the cover to vary its length while maintaining its surface area.
  • the cover may be configured to be compressible and expandable in its length direction, wherein the length is varied mainly due to the folding of the cover rather than elastic properties of the material.
  • the cover may be considered to be formed of an inelastic material.
  • a length of the cover enclosing the at least a part of the core may exceed a length of the at least a part of the core when the at least a part of the core is arranged in the constricting state.
  • a first end portion of the attacher may be configured to be invaginated by the wall portion and a second end portion to be attached to the movement restriction device.
  • the first portion and the second portion may extend in different directions relative to each other, wherein the first portion may be configured to be invaginated by the wall portion to hinder rotation of the movement restriction device around a first axis, and wherein the second portion may be configured to be invaginated by the wall portion to hinder rotation of the movement restriction device around a second axis, different from the first axis.
  • the first and second portions of the attacher may be curved to follow a curvature of the wall portion.
  • the first portion and the second portion may be arranged at an angle to each other, the angle being in the interval of 60-120 degrees, such as 90 degrees.
  • the attacher may be configured to be releasably attached to the movement restriction device.
  • the attacher may be configured to allow a position of the movement restriction device to be adjusted after invagination of the attachment means.
  • the apparatus may be configured to allow a distance between the movement restriction device and the attacher to be varied to allow the position of the movement restriction device relative to the diaphragm to be adjusted.
  • the apparatus may be configured to allow an orientation of the movement restriction device relative to the attachments means to be varied to allow the position of the movement restriction device relative to the diaphragm to the adjusted.
  • the attacher may comprise a third portion, configured to be arranged to protrude from the wall portion when implanted, and to define a distance between the wall portion and the movement restriction device.
  • the third portion may comprise a curvature allowing the third portion to be arranged to point away from the esophagus when implanted.
  • the movement restriction device and the attacher may be integrally formed into a single piece.
  • each of the movement restriction device and the attachments means may comprise a biocompatible outer surface.
  • the attacher may comprises an outer surface configured to promote tissue growth.
  • the attacher may be formed of a metal.
  • the movement restriction device may be formed of a polymer.
  • an outer surface of the movement restriction device may comprise a material for hindering growth of fibrotic tissue.
  • the apparatus may be placed such that the movement restriction device rests against the outside of the fundus at a position between the cardiac sphincter and the portion of the fundus that is to be affixed to the esophagus.
  • the apparatus may be placed such that the portion of the fundus that is affixed to the esophagus is arranged between the cardiac sphincter and the movement restriction device.
  • the pouch may be formed to be open in a least two positions to form a tunnel through which the apparatus extends.
  • the portion of the fundus may be affixed to the patient’s diaphragm.
  • affixing the portion of the fundus to the esophagus may include suturing or stapling.
  • the support device may comprise a first and a second end portion between which the esophagus can be introduced. The first and second end portions can be coupled to each other so as to fixate the support device to the esophagus in an encircling manner.
  • the method may further comprise inserting a needle or a tube-like instrument into the patient’s abdomen, using the needle or tube-like instrument to fill the abdomen with a gas, placing at least two laparoscopic trocars in the abdomen, inserting a camera through one of the laparoscopic trocars into the abdomen, inserting at least one dissecting tool through one the laparoscopic trocars, dissecting a portion of the stomach, and at least partly closing the pouch by means of sutures, such as barbed sutures, or staples.
  • sutures such as barbed sutures, or staples.
  • the abdominal part of the esophagus and the fundus can be divided by a plane into a ventral and a dorsal side.
  • the method may comprise providing the first line on the dorsal side of the plane and the second line on the ventral side of the plane.
  • the first line may begin less than 1 cm above the angle of His and the second line began less than 3 cm above the angle of His.
  • the second line may in some examples begin at a distance less than 2 cm from the first line.
  • a separating angle between the first line and the second line may be in the range of 90-150 degrees.
  • the method may comprise providing an additional fastener between the first line and the second line, at the top of the fundus portion.
  • the fasteners may comprise staples.
  • the fasteners may comprise sutures, such as for example barbed sutures.
  • the first line of fasteners may for example comprise a first continuous suture, and the second line of fasteners a second continuous suture.
  • the method may further comprises placing a movement restriction device on the fundus, forming a pouch in the fundus, arranging the movement restriction device at least partly in the pouch, and invaginating the movement restriction device by the fundus by at least partly closing the pouch by fasteners.
  • the movement restriction device may be arranged at a position between the diaphragm and the cardiac sphincter to hinder the cardia from sliding through the diaphragm opening into the patient’s thorax.
  • the movement restriction device may be invaginated after affixing the fundus portion to the esophagus.
  • the pouch may be formed to be open in a least two positions to form a tunnel through which the movement restriction device may extend.
  • the fundus may be affixed to the diaphragm.
  • an energy source may be provided.
  • the energy source may be configured to be implanted in the body of the patient.
  • the energy source may be configured to provide energy consuming components of the implant with electrical power. Examples of energy consuming components include controllers, sensors, electrodes, and the like, as outlined above in connection with the previous embodiments and examples.
  • the energy source may be configured to provide the electrode arrangement, or electrode, as outlined above with electrical power.
  • the implantable energy source may be configured to be arranged inside, or integrated with, the implanted device, such as the movement restriction device, support device, attachment means, core, or cover according to any of the embodiments and examples described above.
  • the energy source, or a part of the energy source may be configured to be implanted outside the apparatus or implanted device, such as for example subcutaneously.
  • the energy source may comprise a primary cell, or galvanic cell, designed to be discarded after use, and not recharged like a secondary cell.
  • the energy source may comprise a secondary cell, or rechargeable battery, designed to be recharged repeatedly.
  • the implantable energy source may be configured to be charged by an external energy source, i.e., an energy source arranged outside the patient’s body.
  • an implantable charger which may be configured to be electrically connected to the implantable energy source and to enable charging of the implantable energy source by the external energy source.
  • the charger may be configured to transmit the electrical power from the outside of the patient’s body to the implanted energy source.
  • the transmission may for example be performed wirelessly from the external source, and the charger may in some examples comprise an electromagnetic coil for facilitating the transfer.
  • the charger may be configured to control the charging of the implantable energy source by controlling a receipt of electrical power from the external energy source at the implantable charger, and/or by controlling a transmission of electrical power from the external energy source to the implantable charger.
  • the charging of the implantable energy source may be controlled based on a functional status of the implanted energy source. This may for example be realized by controlling the electrical power delivered or emitted by an external energy source, or by controlling the electrical power received by a charger as outlined above. Further, the charging may in some examples be controlled by controlling the electrical power delivered by the charger to the implantable energy source, either by controlling the power output from the charger or by controlling the power received or absorbed by the implantable energy source. Thus, it will be appreciated that the charging of the implantable energy source may be controlled by varying or controlling the electrical power, supplied by the external energy source, at any point along the way to the implantable energy source. As exemplified above, the electrical power that is supplied to the implantable energy source may hence be controlled at the external energy source, at the charger or at the implantable energy source itself.
  • the functional status of the implanted energy source may for example include a charge level or a temperature.
  • the temperature may for example be related to the energy source, the muscle tissue, or a part of the implant such as the electrode arrangement.
  • the charging may be reduced or even stopped in case the charge level (or accumulated energy) reaches an upper limit, or in case the temperature exceeds a predetermined interval.
  • a controller for controlling various parts or functions of the implanted device or apparatus according to any of the embodiments described above.
  • the controller may for example be configured to include the functional status of the implanted energy source in a signal that is transmitted to the outside of the body.
  • the controller may be configured to be operable connected to the electrode arrangement for controlling the electrical stimulation of the muscle tissue.
  • the stimulation may for example be controlled such that the muscle tissue is stimulated by a series of electrical pulses.
  • the electrical pulses may be characterized by their voltage and/or current.
  • a pulse of a first polarity may be followed by a pulse of a second, reversed polarity.
  • the first polarity may for example be a positive current and the second polarity a negative current relative a current flow direction.
  • the first polarity may be characterized by a positive voltage relative to a reference such as ground, and the second polarity by a negative voltage.
  • the controller may be configured to generate a pulsed electrical stimulation signal comprising a pulse frequency of 0.01-150 Hz.
  • the pulse duration may be 0.01-100 ms, and the pulse amplitude in the interval 1-15 mA.
  • Specific examples of electrical stimulation signals may be characterized by a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms and a pulse amplitude of 3-10 mA.
  • the controller may further be configured to generate a pulsed electrical stimulation signal having a varying composition, including different periods including build-up periods in which the amplitude is gradually increasing, stimulation periods in which the stimulation is ongoing, and pause periods wherein the stimulation is paused.
  • the electrical stimulation signal may comprise a build-up period of 0.01-2 s, a stimulation period of 1-60 s, and a stimulation pause of 0.01-60 s.
  • the signal may comprises a pulse frequency of 1-50 Hz and a pulse duration of 0. 1-10 ms.
  • These periods may be varied and combined depending on the desired stimulation of the muscle tissue and may further be varied based on a response which fort example may be monitored by means of a sensor connected to the controller.
  • the sensor may for example be configured to measure a motoric response in the muscle tissue, which may be measured as a mechanical movement or an electrical response.
  • an implantable sensor for sensing action potentials generated by pacemaker cells of the muscle tissue.
  • the sensor may be communicatively coupled to the controller, which may be configured to control the electrical stimulation based at least partly on the sensed action potentials. This may be particularly advantageous when stimulating smooth muscle tissue, which may exhibit period contractions that are paced by the pacemaker cells.
  • the present embodiments thus allow for the electrical stimulation signal to be tailored to amplify the sensed action potentials.
  • the controller may comprise an external controller configured to be arranged outside the patient’s body, and an internal controller, or implantable controller, configured to be arranged inside the patient’s body.
  • the wireless remote control may comprise an external signal transmitter configured to communicate with the internal controller.
  • the internal controller may thus be configured to receive a signal transmitted by the external signal transmitter and to control an operation of the apparatus or medical implant based on the signal.
  • the signal may in some examples be selected from the group consisting of: a sound signal, an ultrasound signal, an electromagnetic signal, and infrared signal, a visible light signal, an ultra violet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal and a gamma radiation signal.
  • the average surface roughness is Ra as defined according to ISO 21920-2:2021.
  • the average surface roughness is Sa as defined according to ISO 25178-2:2021.
  • the average surface roughness is in the range of 0.1-0.5 pm.
  • the average surface roughness is in the range of 0.1-0.3 pm.
  • the implantable movement restriction device comprises a polymer material.
  • implantable movement restriction device comprises at least one of a silicone-based material and a polyurethane -based material.
  • second solid material comprises at least one of a polypropylene -based and a polyethylenebased material.
  • an indentation hardness on the Shore A scale measured on the outer surface is at least 50.
  • indentation hardness is measured by the durometer method defined in part 4 of ISO 48-4:2018.
  • an indentation hardness on the Shore A scale measured on the outer surface is no more than 70.
  • an indentation hardness on the Shore A scale measured on the outer surface is in the range of 55 to 65.
  • the implantable movement restriction device comprises a core part and at least one outer part, configured to be assembled to the implantable movement restriction device.
  • the core part comprises a fluid.
  • the core part comprises a liquid having a density a below 1000 kg/m3.
  • the liquid comprises at least one selected from a list of: oil-based liquids, and alcohol based liquids.
  • the core part comprises a gas.
  • the core part comprises a plurality of volumes of gas enclosed by an enclosing material.
  • the core part comprises a solid polymer material enclosing the enclosing material, and wherein the enclosing material is harder than the solid polymer material.
  • the plurality of volumes of gas enclosed by an enclosing material makes up at least 10 volume percent of the second volume, more preferably at least 20 volume percent of the second volume, and even more preferably at least 30 volume percent of the at least one outer part.
  • the enclosing material comprises glass.
  • the implantable movement restriction device comprises a contrast agent.
  • the implantable movement restriction device comprises the contrast agent BaSO4.
  • the implantable movement restriction device comprises the contrast agent in an amount of 1-15 % by weight of the implantable movement restriction device.
  • the implantable movement restriction device comprises the contrast agent in an amount of 1-6% by weight of the implantable movement restriction device.
  • the implantable movement restriction device comprises the contrast agent in an amount of 8-15 % by weight of the implantable movement restriction device.
  • the core part comprises the contrast agent in an amount of 8-15 % by weight of the core part.
  • the at least one outer part comprises the contrast agent in an amount of 1- 6% by weight of the implantable movement restriction device.
  • the indentation hardness is indentation hardness is measured by the durometer method defined in part 4 of ISO 48-4:2018.
  • an indentation hardness on the Shore A scale measured on the outer surface is no more than 70.
  • an indentation hardness on the Shore A scale measured on the outer surface is in the range of 55 to 65.
  • the core part comprises a fluid.
  • the core part comprises a liquid having a density a below 1000 kg/m3.
  • the liquid comprises at least one selected from a list of: oil-based liquids, and alcohol based liquids.
  • the core part comprises a gas.
  • the core part comprises a plurality of volumes of gas enclosed by an enclosing material.
  • the core part comprises a solid polymer material enclosing the enclosing material, and wherein the enclosing material is harder than the solid polymer material.
  • the plurality of volumes of gas enclosed by an enclosing material makes up at least 10 volume percent of the second volume, more preferably at least 20 volume percent of the second volume, and even more preferably at least 30 volume percent of the at least one outer part.
  • the enclosing material comprises glass.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a first part, a second part, and a first distance element.
  • the first and second part are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the first and second part are capable of disconnecting from each other, such that the first and second part individually can pass through the gastro-intestinal tract, and the first distance element is configured to create a space located between the first and second part.
  • the space is configured to allow in-growth of fibrotic tissue between portions of the first and second parts.
  • the space is confined at least partially by a first surface of the first part and a second surface of the second part and wherein the first and second surfaces are positioned opposite each other when the first and second parts are connected.
  • a line segment of a first straight line is bounded by a first point on the first surface and a second point on the second surface, the line segment of the first straight line is more than 1mm.
  • a line segment of a second straight line is bounded by a third point on the first surface and a fourth point on the second surface. The line segment of the second straight line is more than 1mm and the first straight line is parallel to the second straight line.
  • the first and second straight lines intersect a third straight line which also intersects the center of gravity of the functional movement restriction device, and a distance between the first and second straight lines is more than 2mm for allowing in-growth of fibrotic tissue for aiding in the fixation of the functional movement restriction device to the stomach wall.
  • the first distance element is integrated in at least one of the first and second part, and the first distance element may protrude from a surface of at least one of the first and second part.
  • the implantable medical device further comprises a first separate distance part comprising the first distance element.
  • At least one of the first and second part may further comprise a recess configured to receive a portion of the first distance element.
  • the first distance element may in any of the embodiments herein comprise at least a first and second portion configured to be placed at a distance from each other.
  • the implantable medical device further comprises at least a third part, and the first, second and third parts may be configured to be connected to each other for forming at least a portion of the functional movement restriction device.
  • the implantable medical device may further comprise a second distance element, and the first distance element may be configured to create a space between the first and second part and the second distance element may be configured to create a space between the first and third part.
  • the first and second distance element may be portions of a separate distance part.
  • At least one of the first, second and third parts may comprise a recess configured to receive a portion of the distance element.
  • the space created by the distance element may have a volume exceeding 100mm3.
  • the space forms a recess in the implantable medical device, and the recess has a depth exceeding 2mm and a width exceeding 1mm.
  • the distance element is configured to prevent at least one of: rotation between the first and second part, linear movement between the first and second part in a first direction, and linear movement between the first and second part in a first and second direction.
  • the first separate distance part is configured to be placed centrally in the functional movement restriction device, and the center of gravity of the first separate distance part may substantially coincide with the center of gravity of the functional movement restriction device.
  • the first separate distance part comprises at least one rim comprising at least a first and a second surface.
  • the first surface of the rim may be configured to engage a surface of the first part and the second surface of the flange is configured to engage a surface of the second part.
  • the first and second surfaces of the at least one rim may be parallel.
  • the first separate distance part may comprise at least two rims.
  • the first rim may comprise at least a first and a second surface, the first surface of the first rim may be configured to engage a surface of the first part and the second surface of the first rim may be configured to engage a surface of the second part.
  • the second rim may comprise at least a first and a second surface, and the first surface of the second rim may be configured to engage a surface of the first part and the second surface of the second rim may be configured to engage a surface of the third part.
  • the first surfaces of the first rim and the first surface of the second rim are angled relative to each other with an angle in the range 20° - 70°.
  • the first surfaces of the first rim and the first surface of the second rim are angled relative to each other with an angle in the range 40° - 50°.
  • the first surfaces of the first rim and the first surface of the second rim are perpendicular.
  • the first distance element may be configured to engage the recess in at least one of the first and second part in a direction of a length axis of the distance element, and the portion of the first distance element configured to enter the recess of the second part may comprise at least one surface being angled relative to the length axis of the distance element.
  • the surface of the first distance element being angled may be configured to face a surface of the recess in at least one of the first and second part being angled with an angle different from the angle of the first distance element, and wherein a point on the angled surface of the first distance element is configured to abut a point on the angled surface of the recess.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than half of the length of the angled surface of the first distance element.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than one third of the length of the angled surface of the first distance element.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the portion of the first distance element configured to enter the recess of the second part comprises a tapered portion.
  • the tapered portion is tapered with an angle in the range 20° - 100°.
  • the recess in at least one of the first and second part is tapered, such that two surfaces on opposite sides of the tapered portion of the first distance element faces two surfaces on opposite sides of the tapered recess, when the tapered portion of the first distance element is inserted into the recess.
  • the tapered recess may be tapered with an angle in the range 30° - 135°.
  • the tapered portion of the first distance element is tapered with a first angle and the tapered recess in at least one of the first and second part is tapered with a second angle, and the second angle is larger than the first angle.
  • the second angle may be more than 3° larger than the first angle, or more than 5° larger than the first angle, or more than 10° larger than the first angle.
  • the tapered portion of the first distance element, and the tapered recess in at least one of the first and second part is conical or frustum-conical.
  • the tapered portion of the first distance element has the shape of a pyramid with a polygonal base.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a curvature.
  • the surface of the first distance element having a curvature is configured to face a surface of the recess in at least one of the first and second part.
  • a point on the surface of the first distance element having the curvature is configured to abut a point on the surface of the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than half of the length of the angled surface of the first distance element, when the first distance element has been positioned in the recess in at least one of the first and second part.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than one third of the length of the angled surface of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than one third of the length of the angled surface of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the portion of the first distance element configured to enter the recess of the second part comprises at least one surface having a first and second curvature extending in perpendicular directions.
  • the portion of the first distance element configured to enter the recess of the second part may comprise at least one spherical surface.
  • the recess in at least one of the first and second part is tapered, such that two curved surfaces on opposite sides of the portion of the first distance element configured to enter the recess of the first or second part faces two surfaces on opposite sides of the tapered recess, when the portion of the first distance element configured to enter the recess of the first or second part is inserted into the recess.
  • the recess in at least one of the first and second part comprises at least one surface having a curvature.
  • the recess in at least one of the first and second part may comprise at least one surface having a first and second curvature extending in perpendicular directions.
  • the recess in at least one of the first and second part comprises at least one spherical surface.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a curvature with a first radius and the recess in at least one of the first and second part comprises at least one surface having a curvature with a second radius.
  • the second radius is according to one embodiment longer than the first radius.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a first and second curvature extending in perpendicular directions.
  • the recess in at least one of the first and second part comprises at least one surface having a first and second curvature extending in perpendicular directions, and the sum of the radii of the first and second curvatures of the recess in at least one of the first and second part is longer than the sum of the radii of the first and second curvature of the portion of the first distance element configured to enter the recess.
  • the functional movement restriction device or the boundary of the functional movement restriction device may be elongated.
  • the functional movement restriction device may be elongated such that a longest length is more than 1,5 times a widest width.
  • the functional movement restriction device comprises a bend
  • the functional movement restriction device comprises a bent center axis following the elongation of the functional movement restriction device.
  • a first portion of the functional movement restriction device is configured to be positioned such that a first portion of the bent center axis is parallel to the caudal -cranial axis of the patient, and a second portion of the bent center axis is angled relative to the caudal -cranial axis of the patient, with an angle exceeding 5°.
  • the second portion of the bent center axis is configured to be positioned in the stomach such that it is angled towards the esophagus.
  • At least one of the first and second part has a shape corresponding to an ellipsoid wedge or a truncated ellipsoid wedge.
  • At least one of the first and second part has a shape corresponding to a spherical wedge or a truncated spherical wedge.
  • At least one of the first and second part may have a shape corresponding to a portion of an ellipsoid wedge or a portion of a truncated ellipsoid wedge. According to one embodiment, at least one of the first and second part has a shape corresponding to a hemiellipsoid wedge or a truncated hemiellipsoid wedge.
  • At least one of the first and second part may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.
  • At least one of the first and second part has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.
  • At least one of the first and second part has a shape corresponding to an ellipsoid segment or a portion of an ellipsoid segment.
  • At least one of the first and second part has a shape corresponding to a spherical segment or a portion of a spherical segment.
  • the functional movement restriction device may in any of the embodiments have a shape corresponding to an ellipsoid or a truncated ellipsoid.
  • the functional movement restriction device or the boundary of the functional movement restriction device, has a shape corresponding to a sphere or a truncated sphere.
  • At least the periphery of at least one of the first and second part has a shape corresponding to a cylinder.
  • the combined periphery of the first and second part has a shape corresponding to a cylinder.
  • the periphery of the first part has a shape corresponding to a first cylinder having a first radius
  • the periphery of the second part has a shape corresponding to a second cylinder having a second radius
  • the first and second radii are different.
  • the functional movement restriction device or the boundary of the functional movement restriction device, comprises a stadium shaped cross-section, or a truncated stadium shaped cross-section.
  • the functional movement restriction device comprises a bent stadium shaped cross-section, or a truncated bent stadium shaped cross-section.
  • a periphery of the first part has a shape corresponding to a cylinder or an ellipsoid segment
  • a periphery of the second part has a shape corresponding to a cylinder or an ellipsoid segment
  • the first part comprises at least one protrusion protruding from a first base surface and the second part comprises at least one recess in a first base surface
  • the at least one protrusion is adapted to be placed at least partially in the at least one recess.
  • the at least one protrusion may be adapted to engage the at least one recess and the first part may further comprise at least one recess in a second base surface.
  • the position of the at least one protrusion may coincide with the position of the at least one recess, such that the recess overlaps the protrusion when the first part is viewed in a direction normal to the first base surface.
  • the at least one recess may recess into the at least one protrusion.
  • the at least one protrusion may have the shape of a pyramid with a polygonal base.
  • the first part further comprises at least one protrusion in a second base surface
  • the second part may further comprise at least one protrusion in a second base surface
  • the second part may further comprise at least one recess in a second base surface
  • the implantable medical device further comprises a third part
  • the first part further comprises a recess in a second base surface
  • the second part further comprises a protrusion protruding from a second base surface
  • the third part comprises a protrusion protruding from a first base surface and a recess in a second base surface
  • the protrusion of the first part is configured to be at least partially inserted into the recess of the second part
  • the protrusion of the second part is configured to be at least partially inserted into the recess of the third part
  • the first, second and third parts are configured to be assembled for forming at least a portion of a functional implantable medical device, and wherein the recesses and protrusions stabilize the parts relative to each other when assembled.
  • the area of the first base surface of the first part is smaller than the area of the first base surface of the second part.
  • the at least one protrusion protruding from the first base surface of the first part comprises the distance element.
  • the medical device is further configured to treat obesity by the movement restriction device being configured to protrude into the stomach and thereby reducing the volume of the cavity of the stomach.
  • the functional movement restriction device may have a volume in the range 100cm3 - 1000cm3, or in the range 100cm3 - 500cm3.
  • the functional implantable medical device may have a length in the range 2,5cm - 15cm or in the range 5cm - 15cm, or in the range 7cm - 15cm, or in the range 8cm - 15cm, or in the range 8cm - 12cm.
  • the movement restriction device may in any of the embodiments herein comprises a surface friction reducing coating covering at least a part of the surface of the movement restriction device.
  • the surface friction reducing coating may be configured to reduce the friction between the movement restriction device and the tissue of the stomach wall by which the movement restriction device is at least partially invaginated.
  • the implantable medical device may further comprise a sensor configured to sense at least one of a force and a pressure, for monitoring a pressure or force exerted by the implantable movement restriction device on the stomach wall of the patient.
  • the movement restriction device comprises a first portion having a first volume enclosed by material of the implantable movement restriction device and a second portion, different from the first portion, having a second volume enclosed by material of the implantable movement restriction device.
  • the first volume and the second volumes may be equally large and the first volume may have a higher density than the second volume, and the second volume may have a density below 1000 kg/m3.
  • the implantable medical device may be configured to be fixated to the stomach wall of the patient to act as a movement restriction device for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a first part, a second part, and a distance element.
  • the first and second part may be configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the first and second parts are capable of disconnecting from each other if at least one of the first and second part becomes positioned inside of the stomach, such that the first and second part individually can pass through the gastro-intestinal tract, and the distance element is configured to create a space between the first and second part.
  • the space is configured to allow in-growth of fibrotic tissue between portions of the first and second parts, and the space forms a recess in the functional movement restriction device.
  • the recess may be more than 1mm wide and more than 2mm deep for allowing in-growth of fibrotic tissue for aiding in the fixation of the functional movement restriction device to the stomach wall.
  • the first distance element is integrated in at least one of the first and second part, and the first distance element may protrude from a surface of at least one of the first and second part.
  • the implantable medical device further comprises a first separate distance part comprising the first distance element.
  • At least one of the first and second part may further comprise a recess configured to receive a portion of the first distance element.
  • the first distance element may in any of the embodiments herein comprise at least a first and second portion configured to be placed at a distance from each other.
  • the implantable medical device further comprises at least a third part, and the first, second and third parts may be configured to be connected to each other for forming at least a portion of the functional movement restriction device.
  • the implantable medical device may further comprise a second distance element, and the first distance element may be configured to create a space between the first and second part and the second distance element may be configured to create a space between the first and third part.
  • the first and second distance element may be portions of a separate distance part.
  • At least one of the first, second and third parts may comprise a recess configured to receive a portion of the distance element.
  • the space created by the distance element may have a volume exceeding 100mm3.
  • the space forms a recess in the implantable medical device, and the recess has a depth exceeding 2mm and a width exceeding 1mm.
  • the distance element is configured to prevent at least one of: rotation between the first and second part, linear movement between the first and second part in a first direction, and linear movement between the first and second part in a first and second direction.
  • the first separate distance part is configured to be placed centrally in the functional movement restriction device, and the center of gravity of the first separate distance part may substantially coincide with the center of gravity of the functional movement restriction device.
  • the first separate distance part comprises at least one rim comprising at least a first and a second surface.
  • the first surface of the rim may be configured to engage a surface of the first part and the second surface of the flange is configured to engage a surface of the second part.
  • the first and second surfaces of the at least one rim may be parallel.
  • the first separate distance part may comprise at least two rims.
  • the first rim may comprise at least a first and a second surface, the first surface of the first rim may be configured to engage a surface of the first part and the second surface of the first rim may be configured to engage a surface of the second part.
  • the second rim may comprise at least a first and a second surface, and the first surface of the second rim may be configured to engage a surface of the first part and the second surface of the second rim may be configured to engage a surface of the third part.
  • the first surfaces of the first rim and the first surface of the second rim are angled relative to each other with an angle in the range 20° - 70°.
  • the first surfaces of the first rim and the first surface of the second rim are angled relative to each other with an angle in the range 40° - 50°.
  • the first surfaces of the first rim and the first surface of the second rim are perpendicular.
  • the first distance element may be configured to engage the recess in at least one of the first and second part in a direction of a length axis of the distance element, and the portion of the first distance element configured to enter the recess of the second part may comprise at least one surface being angled relative to the length axis of the distance element.
  • the surface of the first distance element being angled may be configured to face a surface of the recess in at least one of the first and second part being angled with an angle different from the angle of the first distance element, and wherein a point on the angled surface of the first distance element is configured to abut a point on the angled surface of the recess.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than half of the length of the angled surface of the first distance element.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than one third of the length of the angled surface of the first distance element. According to one embodiment, the angled surface of the first distance element abuts the angled surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the portion of the first distance element configured to enter the recess of the second part comprises a tapered portion.
  • the tapered portion is tapered with an angle in the range 20° - 100°.
  • the recess in at least one of the first and second part is tapered, such that two surfaces on opposite sides of the tapered portion of the first distance element faces two surfaces on opposite sides of the tapered recess, when the tapered portion of the first distance element is inserted into the recess.
  • the tapered recess may be tapered with an angle in the range 30° - 135°.
  • the tapered portion of the first distance element is tapered with a first angle and the tapered recess in at least one of the first and second part is tapered with a second angle, and the second angle is larger than the first angle.
  • the second angle may be more than 3° larger than the first angle, or more than 5° larger than the first angle, or more than 10° larger than the first angle.
  • the tapered portion of the first distance element, and the tapered recess in at least one of the first and second part is conical or frustum-conical.
  • the tapered portion of the first distance element has the shape of a pyramid with a polygonal base.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a curvature.
  • the surface of the first distance element having a curvature is configured to face a surface of the recess in at least one of the first and second part.
  • a point on the surface of the first distance element having the curvature is configured to abut a point on the surface of the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than half of the length of the angled surface of the first distance element, when the first distance element has been positioned in the recess in at least one of the first and second part.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than one third of the length of the angled surface of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than one third of the length of the angled surface of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the portion of the first distance element configured to enter the recess of the second part comprises at least one surface having a first and second curvature extending in perpendicular directions.
  • the portion of the first distance element configured to enter the recess of the second part may comprise at least one spherical surface.
  • the recess in at least one of the first and second part is tapered, such that two curved surfaces on opposite sides of the portion of the first distance element configured to enter the recess of the first or second part faces two surfaces on opposite sides of the tapered recess, when the portion of the first distance element configured to enter the recess of the first or second part is inserted into the recess.
  • the recess in at least one of the first and second part comprises at least one surface having a curvature.
  • the recess in at least one of the first and second part may comprise at least one surface having a first and second curvature extending in perpendicular directions.
  • the recess in at least one of the first and second part comprises at least one spherical surface.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a curvature with a first radius and the recess in at least one of the first and second part comprises at least one surface having a curvature with a second radius.
  • the second radius is according to one embodiment longer than the first radius.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a first and second curvature extending in perpendicular directions.
  • the recess in at least one of the first and second part comprises at least one surface having a first and second curvature extending in perpendicular directions, and the sum of the radii of the first and second curvatures of the recess in at least one of the first and second part is longer than the sum of the radii of the first and second curvature of the portion of the first distance element configured to enter the recess.
  • the functional movement restriction device or the boundary of the functional movement restriction device may be elongated.
  • the functional movement restriction device may be elongated such that a longest length is more than 1,5 times a widest width.
  • the functional movement restriction device comprises a bend
  • the functional movement restriction device comprises a bent center axis following the elongation of the functional movement restriction device.
  • a first portion of the functional movement restriction device is configured to be positioned such that a first portion of the bent center axis is parallel to the caudal -cranial axis of the patient, and a second portion of the bent center axis is angled relative to the caudal -cranial axis of the patient, with an angle exceeding 5°.
  • the second portion of the bent center axis is configured to be positioned in the stomach such that it is angled towards the esophagus.
  • At least one of the first and second part has a shape corresponding to an ellipsoid wedge or a truncated ellipsoid wedge.
  • At least one of the first and second part has a shape corresponding to a spherical wedge or a truncated spherical wedge.
  • At least one of the first and second part may have a shape corresponding to a portion of an ellipsoid wedge or a portion of a truncated ellipsoid wedge.
  • At least one of the first and second part has a shape corresponding to a hemiellipsoid wedge or a truncated hemiellipsoid wedge.
  • At least one of the first and second part may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.
  • At least one of the first and second part has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.
  • At least one of the first and second part has a shape corresponding to an ellipsoid segment or a portion of an ellipsoid segment.
  • At least one of the first and second part has a shape corresponding to a spherical segment or a portion of a spherical segment.
  • the functional movement restriction device may in any of the embodiments have a shape corresponding to an ellipsoid or a truncated ellipsoid.
  • the functional movement restriction device or the boundary of the functional movement restriction device, has a shape corresponding to a sphere or a truncated sphere.
  • At least the periphery of at least one of the first and second part has a shape corresponding to a cylinder.
  • the combined periphery of the first and second part has a shape corresponding to a cylinder.
  • the periphery of the first part has a shape corresponding to a first cylinder having a first radius
  • the periphery of the second part has a shape corresponding to a second cylinder having a second radius
  • the first and second radii are different.
  • the functional movement restriction device or the boundary of the functional movement restriction device, comprises a stadium shaped cross-section, or a truncated stadium shaped cross-section.
  • the functional movement restriction device comprises a bent stadium shaped cross-section, or a truncated bent stadium shaped cross-section.
  • a periphery of the first part has a shape corresponding to a cylinder or an ellipsoid segment
  • a periphery of the second part has a shape corresponding to a cylinder or an ellipsoid segment
  • the first part comprises at least one protrusion protruding from a first base surface and the second part comprises at least one recess in a first base surface
  • the at least one protrusion is adapted to be placed at least partially in the at least one recess.
  • the at least one protrusion may be adapted to engage the at least one recess and the first part may further comprise at least one recess in a second base surface.
  • the position of the at least one protrusion may coincide with the position of the at least one recess, such that the recess overlaps the protrusion when the first part is viewed in a direction normal to the first base surface.
  • the at least one recess may recess into the at least one protrusion.
  • the at least one protrusion may have the shape of a pyramid with a polygonal base.
  • the first part further comprises at least one protrusion in a second base surface
  • the second part may further comprise at least one protrusion in a second base surface
  • the second part may further comprise at least one recess in a second base surface
  • the implantable medical device further comprises a third part
  • the first part further comprises a recess in a second base surface
  • the second part further comprises a protrusion protruding from a second base surface
  • the third part comprises a protrusion protruding from a first base surface and a recess in a second base surface
  • the protrusion of the first part is configured to be at least partially inserted into the recess of the second part
  • the protrusion of the second part is configured to be at least partially inserted into the recess of the third part
  • the first, second and third parts are configured to be assembled for forming at least a portion of a functional implantable medical device, and wherein the recesses and protrusions stabilize the parts relative to each other when assembled.
  • the area of the first base surface of the first part is smaller than the area of the first base surface of the second part.
  • the at least one protrusion protruding from the first base surface of the first part comprises the distance element.
  • the medical device is further configured to treat obesity by the movement restriction device being configured to protrude into the stomach and thereby reducing the volume of the cavity of the stomach.
  • the functional movement restriction device may have a volume in the range 100cm3 - 1000cm3, or in the range 100cm3 - 500cm3.
  • the functional implantable medical device may have a length in the range 2,5cm - 15cm or in the range 5cm - 15cm, or in the range 7cm - 15cm, or in the range 8cm - 15cm, or in the range 8cm - 12cm.
  • the movement restriction device may in any of the embodiments herein comprises a surface friction reducing coating covering at least a part of the surface of the movement restriction device.
  • the surface friction reducing coating may be configured to reduce the friction between the movement restriction device and the tissue of the stomach wall by which the movement restriction device is at least partially invaginated.
  • the implantable medical device may further comprise a sensor configured to sense at least one of a force and a pressure, for monitoring a pressure or force exerted by the implantable movement restriction device on the stomach wall of the patient.
  • the movement restriction device comprises a first portion having a first volume enclosed by material of the implantable movement restriction device and a second portion, different from the first portion, having a second volume enclosed by material of the implantable movement restriction device.
  • the first volume and the second volumes may be equally large and the first volume may have a higher density than the second volume, and the second volume may have a density below 1000 kg/m3.
  • An implantable medical device for treating reflux disease comprising a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm is further provided.
  • the movement restriction device comprises a first part and a second part. The first and second parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the first and second parts are capable of disconnecting from each other, such that the first and second part individually can pass through the gastro-intestinal tract, and a periphery of the first part has a shape corresponding to a cylinder or an ellipsoid segment, and a periphery of the second part has a shape corresponding to a cylinder or an ellipsoid segment.
  • the first part comprises at least one protrusion protruding from a first base surface and the second part comprises at least one recess in a first base surface, and the at least one protrusion is adapted to be placed at least partially in the at least one recess for stabilizing the first and second parts relative to each other.
  • At least one protrusion of a first part the movement restriction device is adapted to engage at least one recess of a second part of the movement restriction device.
  • the first part further comprises at least one recess in a second base surface.
  • the position of the at least one protrusion coincides with the position of the at least one recess, such that the recess overlaps the protrusion when the first part is viewed in a direction normal to the first base surface.
  • the at least one recess may recess into the at least one protrusion.
  • the at least one protrusion is adapted to engage the at least one recess in a direction of a length axis of the protrusion, and the portion of the protrusion adapted to be placed at least partially in the at least one recess comprises at least one surface being angled relative to the length axis of the protrusion.
  • the surface of the protrusion is being angled is configured to face a surface of the recess in the second part being angled with an angle different from the angle of the protrusion.
  • a point on the angled surface of the protrusion is configured to abut a point on the angled surface of the recess.
  • the angled surface of the protrusion abuts the angled surface of the recess over a length being less than half of the length of the angled surface of the protrusion.
  • An angled surface of the protrusion may abut the angled surface of the recess over a length being less than one third of the length of the angled surface of protrusion.
  • the angled surface of the protrusion abuts the angled surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the protrusion, when the portion of the protrusion is inserted into the recess.
  • the portion of the protrusion configured to enter the recess of the second part comprises a tapered portion, and the tapered portion may be tapered with an angle in the range 20° - 150°.
  • the recess in at least one of the first and second part is tapered, such that two surfaces on opposite sides of the tapered portion of the protrusion faces two surfaces on opposite sides of the tapered recess, when the tapered portion of the first distance element is inserted into the recess.
  • the tapered recess may be tapered with an angle in the range 30° - 155°.
  • the tapered portion of the protrusion is tapered with a first angle and the tapered recess in at least one of the first and second part is tapered with a second angle, and the second angle is larger than the first angle.
  • the second angle may be more than 3° larger than the first angle, or more than 5° larger than the first angle, or more than 10° larger than the first angle.
  • the at least one protrusion has the shape of a pyramid with a polygonal base.
  • the first part further comprises at least one protrusion in a second base surface
  • the second part further comprises at least one protrusion in a second base surface
  • the second part may further comprise at least one recess in a second base surface
  • the implantable medical device further comprises a third part.
  • the first part further comprises a recess in a second base surface
  • the second part further comprises a protrusion protruding from a second base surface
  • the third part comprises a protrusion protruding from a first base surface and a recess in a second base surface.
  • the protrusion of the first part is configured to be at least partially inserted into the recess of the second part
  • the protrusion of the second part is configured to be at least partially inserted into the recess of the third part
  • the first, second and third parts are configured to be assembled for forming at least a portion of a functional implantable medical device, and wherein the recesses and protrusions stabilize the parts relative to each other when assembled.
  • the area of the first base surface of the first part is smaller than the area of the first base surface of the second part.
  • the functional movement restriction device may in any of the embodiments have a shape corresponding to an ellipsoid or a truncated ellipsoid.
  • the functional movement restriction device or the boundary of the functional movement restriction device, has a shape corresponding to a sphere or a truncated sphere.
  • At least the periphery of at least one of the first and second part has a shape corresponding to a cylinder.
  • the combined periphery of the first and second part has a shape corresponding to a cylinder.
  • the periphery of the first part has a shape corresponding to a first cylinder having a first radius
  • the periphery of the second part has a shape corresponding to a second cylinder having a second radius
  • the first and second radii are different.
  • the functional movement restriction device or the boundary of the functional movement restriction device, comprises a stadium shaped cross-section, or a truncated stadium shaped cross-section.
  • the functional movement restriction device comprises a bent stadium shaped cross-section, or a truncated bent stadium shaped cross-section.
  • the functional movement restriction device or the boundary of the functional movement restriction device may be elongated.
  • the functional movement restriction device may be elongated such that a longest length is more than 1,5 times a widest width.
  • the functional movement restriction device comprises a bend
  • the functional movement restriction device comprises a bent center axis following the elongation of the functional movement restriction device.
  • a first portion of the functional movement restriction device is configured to be positioned such that a first portion of the bent center axis is parallel to the caudal -cranial axis of the patient, and a second portion of the bent center axis is angled relative to the caudal -cranial axis of the patient, with an angle exceeding 5°.
  • the second portion of the bent center axis is configured to be positioned in the stomach such that it is angled towards the esophagus.
  • the protrusion comprises a first distance element configured to create a space located between the first and second part.
  • the space is configured to allow in-growth of fibrotic tissue between portions of the first and second parts, and wherein the space is confined at least partially by a first surface of the first part and a second surface of the second part and wherein the first and second surfaces are positioned opposite each other when the first and second parts are connected.
  • a line segment of a first straight line is bounded by a first point on the first surface and a second point on the second surface.
  • the line segment of the first straight line is more than 1mm.
  • a line segment of a second straight line is bounded by a third point on the first surface and a fourth point on the second surface.
  • the line segment of the second straight line is more than 1mm and the first straight line is parallel to the second straight line.
  • the first and second straight lines intersect a third straight line which also intersects the center of gravity of the functional movement restriction device, and a distance between the first and second straight lines is more than 2mm for allowing in-growth of fibrotic tissue for aiding in the fixation of the functional movement restriction device to the stomach wall.
  • the protrusion comprises a first distance element configured to create a space located between the first and second part.
  • the space is configured to allow in-growth of fibrotic tissue between portions of the first and second parts and the space forms a recess in the functional implantable medical device.
  • the recess is more than 1mm wide and more than 2mm deep for allowing in-growth of fibrotic tissue for aiding in the fixation of the functional implantable medical device to the stomach wall.
  • the medical device is further configured to treat obesity by the movement restriction device being configured to protrude into the stomach and thereby reducing the volume of the cavity of the stomach.
  • the functional movement restriction device may have a volume in the range 100cm3 - 1000cm3, or in the range 100cm3 - 500cm3.
  • the functional implantable medical device may have a length in the range 2,5cm - 15cm or in the range 5cm - 15cm, or in the range 7cm - 15cm, or in the range 8cm - 15cm, or in the range 8cm - 12cm.
  • the movement restriction device may in any of the embodiments herein comprises a surface friction reducing coating covering at least a part of the surface of the movement restriction device.
  • the surface friction reducing coating may be configured to reduce the friction between the movement restriction device and the tissue of the stomach wall by which the movement restriction device is at least partially invaginated.
  • the implantable medical device may further comprise a sensor configured to sense at least one of a force and a pressure, for monitoring a pressure or force exerted by the implantable movement restriction device on the stomach wall of the patient.
  • the movement restriction device comprises a first portion having a first volume enclosed by material of the implantable movement restriction device and a second portion, different from the first portion, having a second volume enclosed by material of the implantable movement restriction device.
  • the first volume and the second volumes may be equally large and the first volume may have a higher density than the second volume, and the second volume may have a density below 1000 kg/m3.
  • the apparatus comprising an implantable movement restriction device having a shape and size allowing it to be arranged to rest against a fundus wall portion of the patient’s stomach, such that the movement restriction device is implanted at a position between the thoracic diaphragm of the patient and a portion of the fundus wall, and such that movement of the lower esophageal sphincter of the patient’s stomach towards the thoracic diaphragm is restricted to hinder the lower esophageal sphincter from sliding through the opening in the thoracic diaphragm into the patient’s thorax.
  • the apparatus further comprising an electrode arrangement configured to engage and electrically stimulate the lower esophageal sphincter for causing contraction of the lower esophageal sphincter.
  • the apparatus further comprising an electric impedance sensor configured to measure a change in electrical impedance in the tissue of the lower esofageal sphincter or in the esophagus tissue for detecting the patient swallowing, and a stimulation controller configured to control the electrical stimulation of the lower esophageal sphincter in response to signals from the electric impedance sensor.
  • the apparatus further comprises a reference electrode connected to the stimulation controller, and wherein the stimulation controller is configured to generate the output from the sensor based on an electrical interaction between the electric impedance sensor and the reference electrode.
  • the stimulation controller is configured to generate a timevarying signal having a frequency component that varies in the range of 1-10 kHz.
  • the stimulation controller is configured to generate a timevarying signal having a frequency component that varies in the range of 2-8 kHz.
  • the stimulation controller is configured to generate a timevarying signal having a frequency component that varies in the range of 4-6 kHz.
  • the electrode arrangement comprises at least two electrode elements configured to be arranged on opposing sides of the lower esophageal sphincter.
  • the apparatus further comprises a holder configured to support the at least two electrode elements at the opposing sides of the cardiac sphincter.
  • the apparatus further comprises an implantable energy source configured to provide the electrode with electrical power.
  • the implantable energy source is arranged inside the movement restriction device.
  • the implantable medical device for treating obesity is further provided.
  • the implantable medical device is configured to be fixated to the stomach wall and protrude into the stomach and thereby reduce the volume of the cavity of the stomach.
  • the implantable medical device comprises a first part, a second part, and a first distance element.
  • the first and second parts are configured to be connected to each other for forming at least a portion of a functional implantable medical device.
  • the first and second parts are capable of disconnecting from each other, such that the first and second part individually can pass through the gastro-intestinal tract.
  • the first distance element is configured to create a space located between the first and second part.
  • the space is configured to allow in-growth of fibrotic tissue between portions of the first and second parts.
  • the space is confined at least partially by a first surface of the first part and a second surface of the second part.
  • the first and second surfaces are positioned opposite each other when the first and second parts are connected.
  • a line segment of a first straight line is bounded by a first point on the first surface and a second point on the second surface, and the line segment of the first straight line is more than 1mm.
  • a line segment of a second straight line is bounded by a third point on the first surface and a fourth point on the second surface, and the line segment of the second straight line is more than 1mm.
  • the first straight line is parallel to the second straight line, the first and second straight lines intersect a third straight line which also intersects the center of gravity of the functional medical device.
  • a distance between the first and second straight lines is more than 2mm for allowing ingrowth of fibrotic tissue for aiding in the fixation of the functional implantable medical device to the stomach wall.
  • the functional implantable medical device may have a volume in the range 100cm 3 - 1000cm 3 , or preferably in the range 100cm 3 - 500cm 3 .
  • the functional implantable medical device may have a length in the range 2,5cm - 15cm, or more preferably a length in the range 5cm - 15cm and even more preferably a length in the range 7cm - 15cm, or even more preferably a length in the range 8cm - 15cm, and even more preferably a length in the range 8cm - 12cm.
  • the first distance element is integrated in at least one of the first and second part, and the first distance element may protrude from a surface of at least one of the first and second part.
  • the implantable medical device further comprises a first separate distance part comprising the first distance element.
  • At least one of the first and second part may further comprise a recess configured to receive a portion of the first distance element.
  • the first distance element may in any of the embodiments herein comprise at least a first and second portion configured to be placed at a distance from each other.
  • the implantable medical device further comprises at least a third part, and the first, second and third parts may be configured to be connected to each other for forming at least a portion of the functional movement restriction device.
  • the implantable medical device may further comprise a second distance element, and the first distance element may be configured to create a space between the first and second part and the second distance element may be configured to create a space between the first and third part.
  • the first and second distance element may be portions of a separate distance part.
  • at least one of the first, second and third parts may comprise a recess configured to receive a portion of the distance element.
  • the space created by the distance element may have a volume exceeding 100mm3.
  • the space forms a recess in the implantable medical device, and the recess has a depth exceeding 2mm and a width exceeding 1mm.
  • the distance element is configured to prevent at least one of: rotation between the first and second part, linear movement between the first and second part in a first direction, and linear movement between the first and second part in a first and second direction.
  • the first separate distance part is configured to be placed centrally in the functional movement restriction device, and the center of gravity of the first separate distance part may substantially coincide with the center of gravity of the functional movement restriction device.
  • the first separate distance part comprises at least one rim comprising at least a first and a second surface.
  • the first surface of the rim may be configured to engage a surface of the first part and the second surface of the flange is configured to engage a surface of the second part.
  • the first and second surfaces of the at least one rim may be parallel.
  • the first separate distance part may comprise at least two rims.
  • the first rim may comprise at least a first and a second surface, the first surface of the first rim may be configured to engage a surface of the first part and the second surface of the first rim may be configured to engage a surface of the second part.
  • the second rim may comprise at least a first and a second surface, and the first surface of the second rim may be configured to engage a surface of the first part and the second surface of the second rim may be configured to engage a surface of the third part.
  • the first surfaces of the first rim and the first surface of the second rim are angled relative to each other with an angle in the range 20° - 70°.
  • the first surfaces of the first rim and the first surface of the second rim are angled relative to each other with an angle in the range 40° - 50°.
  • the first surfaces of the first rim and the first surface of the second rim are perpendicular.
  • the first distance element may be configured to engage the recess in at least one of the first and second part in a direction of a length axis of the distance element, and the portion of the first distance element configured to enter the recess of the second part may comprise at least one surface being angled relative to the length axis of the distance element.
  • the surface of the first distance element being angled may be configured to face a surface of the recess in at least one of the first and second part being angled with an angle different from the angle of the first distance element, and wherein a point on the angled surface of the first distance element is configured to abut a point on the angled surface of the recess.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than half of the length of the angled surface of the first distance element.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than one third of the length of the angled surface of the first distance element.
  • the angled surface of the first distance element abuts the angled surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the portion of the first distance element configured to enter the recess of the second part comprises a tapered portion.
  • the tapered portion is tapered with an angle in the range 20° - 100°.
  • the recess in at least one of the first and second part is tapered, such that two surfaces on opposite sides of the tapered portion of the first distance element faces two surfaces on opposite sides of the tapered recess, when the tapered portion of the first distance element is inserted into the recess.
  • the tapered recess may be tapered with an angle in the range 30° - 135°.
  • the tapered portion of the first distance element is tapered with a first angle and the tapered recess in at least one of the first and second part is tapered with a second angle, and the second angle is larger than the first angle.
  • the second angle may be more than 3° larger than the first angle, or more than 5° larger than the first angle, or more than 10° larger than the first angle.
  • the tapered portion of the first distance element, and the tapered recess in at least one of the first and second part is conical or frustum-conical.
  • the tapered portion of the first distance element has the shape of a pyramid with a polygonal base.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a curvature.
  • the surface of the first distance element having a curvature is configured to face a surface of the recess in at least one of the first and second part.
  • a point on the surface of the first distance element having the curvature is configured to abut a point on the surface of the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than half of the length of the angled surface of the first distance element, when the first distance element has been positioned in the recess in at least one of the first and second part. According to one embodiment, the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than one third of the length of the angled surface of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than one third of the length of the angled surface of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the surface of the first distance element having a curvature abuts the surface of the recess over a length being less than half of the depth of the recess, measured in a direction coinciding with the direction of the length axis of the first distance element, when the portion of the first distance element is inserted into the recess.
  • the portion of the first distance element configured to enter the recess of the second part comprises at least one surface having a first and second curvature extending in perpendicular directions.
  • the portion of the first distance element configured to enter the recess of the second part may comprise at least one spherical surface.
  • the recess in at least one of the first and second part is tapered, such that two curved surfaces on opposite sides of the portion of the first distance element configured to enter the recess of the first or second part faces two surfaces on opposite sides of the tapered recess, when the portion of the first distance element configured to enter the recess of the first or second part is inserted into the recess.
  • the recess in at least one of the first and second part comprises at least one surface having a curvature.
  • the recess in at least one of the first and second part may comprise at least one surface having a first and second curvature extending in perpendicular directions.
  • the recess in at least one of the first and second part comprises at least one spherical surface.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a curvature with a first radius and the recess in at least one of the first and second part comprises at least one surface having a curvature with a second radius.
  • the second radius is according to one embodiment longer than the first radius.
  • the portion of the first distance element configured to enter the recess of the first or second part comprises at least one surface having a first and second curvature extending in perpendicular directions.
  • the recess in at least one of the first and second part comprises at least one surface having a first and second curvature extending in perpendicular directions, and the sum of the radii of the first and second curvatures of the recess in at least one of the first and second part is longer than the sum of the radii of the first and second curvature of the portion of the first distance element configured to enter the recess.
  • the functional implantable medical device or the boundary of the functional implantable medical device may be elongated.
  • the functional implantable medical device may be elongated such that a longest length is more than 1,5 times a widest width.
  • the functional implantable medical device comprises a bend
  • the functional implantable medical device comprises a bent center axis following the elongation of the functional implantable medical device.
  • a first portion of the functional implantable medical device is configured to be positioned such that a first portion of the bent center axis is parallel to the caudal -cranial axis of the patient, and a second portion of the bent center axis is angled relative to the caudal -cranial axis of the patient, with an angle exceeding 5°.
  • the second portion of the bent center axis is configured to be positioned in the stomach such that it is angled towards the esophagus.
  • At least one of the first and second part has a shape corresponding to an ellipsoid wedge or a truncated ellipsoid wedge.
  • At least one of the first and second part has a shape corresponding to a spherical wedge or a truncated spherical wedge.
  • At least one of the first and second part may have a shape corresponding to a portion of an ellipsoid wedge or a portion of a truncated ellipsoid wedge.
  • At least one of the first and second part has a shape corresponding to a hemiellipsoid wedge or a truncated hemiellipsoid wedge.
  • At least one of the first and second part may have a shape corresponding to a portion of a spherical wedge or a portion of a truncated spherical wedge.
  • At least one of the first and second part has a shape corresponding to a hemispherical wedge or a truncated hemispherical wedge.
  • At least one of the first and second part has a shape corresponding to an ellipsoid segment or a portion of an ellipsoid segment.
  • At least one of the first and second part has a shape corresponding to a spherical segment or a portion of a spherical segment.
  • the functional movement restriction device may in any of the embodiments have a shape corresponding to an ellipsoid or a truncated ellipsoid.
  • the functional implantable medical device or the boundary of the functional implantable medical device, has a shape corresponding to a sphere or a truncated sphere.
  • At least the periphery of at least one of the first and second part has a shape corresponding to a cylinder.
  • the combined periphery of the first and second part has a shape corresponding to a cylinder.
  • the periphery of the first part has a shape corresponding to a first cylinder having a first radius
  • the periphery of the second part has a shape corresponding to a second cylinder having a second radius, and the first and second radii are different.
  • the functional implantable medical device or the boundary of the functional implantable medical device, comprises a stadium shaped cross-section, or a truncated stadium shaped cross-section.
  • the functional implantable medical device comprises a bent stadium shaped cross-section, or a truncated bent stadium shaped cross-section.
  • a periphery of the first part has a shape corresponding to a cylinder or an ellipsoid segment
  • a periphery of the second part has a shape corresponding to a cylinder or an ellipsoid segment
  • the first part comprises at least one protrusion protruding from a first base surface and the second part comprises at least one recess in a first base surface
  • the at least one protrusion is adapted to be placed at least partially in the at least one recess.
  • the at least one protrusion may be adapted to engage the at least one recess and the first part may further comprise at least one recess in a second base surface.
  • the position of the at least one protrusion may coincide with the position of the at least one recess, such that the recess overlaps the protrusion when the first part is viewed in a direction normal to the first base surface.
  • the at least one recess may recess into the at least one protrusion.
  • the at least one protrusion may have the shape of a pyramid with a polygonal base.
  • the first part further comprises at least one protrusion in a second base surface
  • the second part may further comprise at least one protrusion in a second base surface
  • the second part may further comprise at least one recess in a second base surface
  • the implantable medical device further comprises a third part
  • the first part further comprises a recess in a second base surface
  • the second part further comprises a protrusion protruding from a second base surface
  • the third part comprises a protrusion protruding from a first base surface and a recess in a second base surface
  • the protrusion of the first part is configured to be at least partially inserted into the recess of the second part
  • the protrusion of the second part is configured to be at least partially inserted into the recess of the third part
  • the first, second and third parts are configured to be assembled for forming at least a portion of a functional implantable medical device, and wherein the recesses and protrusions stabilize the parts relative to each other when assembled.
  • the area of the first base surface of the first part is smaller than the area of the first base surface of the second part.
  • the at least one protrusion protruding from the first base surface of the first part comprises the distance element.
  • the implantable medical device may in any of the embodiments herein comprises a surface friction reducing coating covering at least a part of the surface of the implantable medical device.
  • the surface friction reducing coating may be configured to reduce the friction between the implantable medical device and the tissue of the stomach wall by which the implantable medical device is at least partially invaginated.
  • the implantable medical device may further comprise a sensor configured to sense at least one of a force and a pressure, for monitoring a pressure or force exerted by the implantable medical device on the stomach wall of the patient.
  • the implantable medical device comprises a first portion having a first volume enclosed by material of the implantable medical device and a second portion, different from the first portion, having a second volume enclosed by material of the implantable medical device.
  • the first volume and the second volumes may be equally large and the first volume may have a higher density than the second volume, and the second volume may have a density below 1000 kg/m3.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • the outer surface of the functional movement restriction device comprises at least four flat surfaces separated from each other and interspaced by at least four curved surfaces, and the combined area of the at least four flat surfaces is in the interval 10% - 20% of the total surface area of the functional movement restriction device.
  • the functional movement restriction device comprises at least five flat surfaces.
  • the outer surface of the functional movement restriction device comprises at least six flat surfaces.
  • the outer surface of the functional movement restriction device comprises at least seven flat surfaces.
  • the outer surface of the functional movement restriction device comprises at least eight flat surfaces.
  • the flat surfaces in any of the embodiments may be elliptical or circular or polygonal.
  • An implantable medical device for treating reflux disease is further provided.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a volume in the range 10cm 3 - 30cm 3 and according to another embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a volume in the range 12cm 3 - 25cm 3 , and according to another embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a volume in the range 15cm 3 - 25cm 3 , and according to another embodiment, the functional movement restriction device or the boundary of the functional movement restriction device has a volume in the range 15cm 3 - 22cm 3 .
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm, the movement restriction device comprises at least two parts, wherein the parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device, and the at least two parts are capable of disconnecting from each other, such that the at least two parts individually can pass through the gastro-intestinal tract.
  • the functional movement restriction device has a height in the range 3cm - 6cm, or a height in the range 3cm - 5cm, or a height in the range 3,5cm - 6cm, or a height in the range 4cm - 6cm.
  • the implantable medical device may further comprise a central part, and the at least two parts may be configured to be connected to the central part for forming at least a portion of the functional movement restriction device.
  • the central part and the at least two parts may be capable of disconnecting from each other, such that the central part and the at least two parts individually can pass through the gastro-intestinal tract.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • At least one of the two outer parts comprises a wedge-shaped portion and the central part comprises a wedge-shaped portion.
  • the wedge-shaped portion of the at least one outer part is configured to be placed in the wedge-shaped portion of the central part, and the wedge- shaped portion of the at least one outer part is wedge-shaped with a first angle.
  • the wedge-shaped portion of the central part is wedge-shaped with a second angle, and wherein the first angle is more than 7° larger than the second angle.
  • the first angle is more than 10° larger than the second angle, and according to another embodiment, the first angle is more than 12° larger than the second angle, and according to another embodiment, the first angle is more than 15° larger than the second angle.
  • the wedge-shaped portion of the at least one outer part may comprise a wedge-shaped recess configured to engage a wedge-shaped protrusion of the central part, or the at least one outer part may comprise a wedge-shaped protrusion configured to engage a wedge-shaped recess of the central part.
  • the wedge-shaped portion of the central part may comprise a wedge-shaped recess or a wedge- shaped protrusion.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • At least one of the two outer parts comprises a wedge-shaped portion and the central part comprises a wedge-shaped portion.
  • the wedge-shaped portion of the central part is configured to be placed in the wedge-shaped portion of the central part, and the wedge-shaped portion of the at least one outer part is wedge-shaped with a first angle, and the wedge-shaped portion of the central part is wedge-shaped with a second angle, and the second angle is more than 7° larger than the first angle.
  • the second angle is more than 10° larger than the first angle, and according to another embodiment, the second angle is more than 12° larger than the first angle, and according to another embodiment, the second angle is more than 15° larger than the first angle.
  • the wedge-shaped portion of the at least one outer part may comprise a wedge-shaped recess or a wedge-shaped protrusion.
  • the wedge-shaped portion of the central part may comprise a wedge-shaped recess or may comprise a wedge-shaped protrusion.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • At least one of the two outer parts comprises a contacting surface configured to be placed in contact with a contacting surface of the central part, and at least one of the contacting surfaces of the at least one outer part and the contacting surface of the central part is curved.
  • the contacting surface of the at least one outer part and the contacting surface of the central part is convex.
  • At least one of the contacting surfaces of the at least one outer part and the contacting surface of the central part is concave. According to one embodiment, at least one of the contacting surfaces of the at least one outer part and the contacting surface of the central part comprises an elliptic point.
  • the contacting surface of the at least one outer part contacts the contacting surface of the central part over less than half of the area of the contacting surface of the at least one outer part.
  • the contacting surface of the at least one outer part contacts the contacting surface of the central part over less than one third of the area of the contacting surface of the at least one outer part.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • the central part comprises at least three vertically extending rims being spaced apart, and each the at least three vertically extending rims have at least one contacting surface configured to contact at least one surface of the at least two outer parts. At least a portion of the at least three vertically extending rims is wedge-shaped with an angle in the range 20° - 60°.
  • a portion of the at least three vertically extending rims is wedge- shaped with an angle exceeding 25°.
  • a portion of the at least three vertically extending rims is wedge- shaped with an angle exceeding 30°.
  • a portion of the at least three vertically extending rims is wedge- shaped with an angle exceeding 35°.
  • the wedge-shaped portion of the at least one vertically extending rim may be tapered in a direction away from the center of gravity of the central part.
  • the vertically extending rim has an elongated wedge-shaped portion, and wherein the elongated wedge-shaped portion of the vertically extending rim is tapered in a direction of the elongation of the vertically extending rim.
  • the implantable medical device may further comprise at least one horizontally extending rim extending substantially perpendicularly from at least one of the vertically extending rims, and the horizontally extending rim may comprise a wedge-shaped portion.
  • the wedge-shaped portion of the horizontally extending rim may be tapered in a direction away from the center of gravity of the central part.
  • the wedge-shaped portion of the horizontally extending rim is wedge-shaped with an angle in the range 20° - 60°.
  • An implantable medical device for treating reflux disease is further provided.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • the central part comprises at least one horizontally extending rim extending in a direction perpendicular to the vertical plane and wherein the central part has at least one contacting surface configured to contact at least one surface of the at least two outer parts.
  • a portion of the horizontally extending rim is wedge-shaped with an angle in the range 20° - 60°.
  • a portion of the horizontally extending rim is wedge-shaped with an angle exceeding 25°, or with an angle exceeding 30°, or with an angle exceeding 35°.
  • the wedge-shaped portion of the horizontally extending rim is tapered in a direction away from the center of gravity of the central part.
  • the implantable medical device further comprises at least two vertically extending rims extending substantially perpendicularly from the horizontally extending rim.
  • the vertically extending rims comprises wedge-shaped portions.
  • the wedge-shaped portion of the vertically extending rims are tapered in a direction away from the center of gravity of the central part.
  • the wedge-shaped portions of the vertically extending rims are wedge-shaped with an angle in the range 20° - 60°.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • the mass of the central part exceeds the mass of at least one of the outer parts.
  • the mass of the central part exceeds the mass of at least one of the outer parts by at least 10%.
  • the mass of the central part exceeds the mass of at least one of the outer parts by at least 20%.
  • the mass of the central part exceeds the mass of at least one of the outer parts by at least 30%.
  • the volume of the central part exceeds the volume of at least one of the outer parts by at least 10%.
  • the volume of the central part exceeds the volume of at least one of the outer parts by at least 20%.
  • the volume of the central part exceeds the volume of at least one of the outer parts by at least 30%.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises a central part, and at least two outer parts.
  • the central part and the at least two outer parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the central part and the at least two outer parts are capable of disconnecting from each other, such that the central part and the at least two outer parts individually can pass through the gastro-intestinal tract.
  • the longest cross-sectional distance of at least one of the outer parts exceeds the longest cross-sectional distance of the central part by at least 20%.
  • the longest cross-sectional distance of at least one of the outer parts exceeds the longest cross-sectional distance of the central part by at least 30%.
  • the longest cross-sectional distance of at least one of the outer parts exceeds the longest cross-sectional distance of the central part by at least 40%.
  • the longest cross-sectional distance of at least one of the outer parts exceeds the longest cross-sectional distance of the central part by at least 50%.
  • an implantable medical device for treating reflux disease comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • At least one of the movement restriction device and the boundary of the movement restriction device has a surface area in the range 20cm 2 - 50cm 2 .
  • At least one of the movement restriction device and the boundary of the movement restriction device has a surface area in the range 25cm 2 - 50cm 2 .
  • At least one of the movement restriction device and the boundary of the movement restriction device has a surface area in the range 25cm 2 - 40cm 2 .
  • At least one of the movement restriction device and the boundary of the movement restriction device has a surface area in the range 20cm 2 - 40cm 2 .
  • At least one of the movement restriction device and the boundary of the movement restriction device has a surface area in the range 20cm 2 - 35cm 2 .
  • the movement restriction device has a surface area in the range 20cm 2 - 30cm 2 .
  • the movement restriction device is elongated and has a height, being a longest cross-sectional distance, and a width, being a longest cross-sectional distance perpendicular to the height, and wherein the height is in the range 1,2 times - 2 times longer than the width.
  • the height is in the range 1,3 times - 2 times longer than the width.
  • the height is in the range 1,2 times - 1,8 times longer than the width.
  • the height is in the range 1,3 times - 1,6 times longer than the width.
  • the movement restriction device has a height in the range 3cm - 5cm, or a height in the range 3,5cm - 6cm, or a height in the range 4cm - 5cm, or a height in the range 4cm - 6cm.
  • At least one of the movement restriction device and the boundary of the movement restriction device has a volume in the range 10cm 3 - 30cm 3 and according to another embodiment, the movement restriction device or the boundary of the movement restriction device has a volume in the range 12cm 3 - 25cm 3 , and according to another embodiment, the movement restriction device or the boundary of the movement restriction device has a volume in the range 15cm 3 - 25cm 3 , and according to another embodiment, the movement restriction device or the boundary of the movement restriction device has a volume in the range 15cm 3 - 22cm 3 .
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm, the movement restriction device comprises at least two parts, wherein the parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device, and the at least two parts are capable of disconnecting from each other, such that the at least two parts individually can pass through the gastro-intestinal tract.
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a surface area in the range 20cm 2 - 50cm 2 .
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a surface area in the range 25cm 2 - 50cm 2 .
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a surface area in the range 25cm 2 - 40cm 2 .
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a surface area in the range 20cm 2 - 40cm 2 .
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a surface area in the range 20cm 2 - 35cm 2 .
  • At least one of the functional movement restriction device and the boundary of the functional movement restriction device has a surface area in the range 20cm 2 - 30cm 2 .
  • the functional movement restriction device is elongated and has a height, being a longest cross-sectional distance, and a width, being a longest cross-sectional distance perpendicular to the height, and wherein the height is in the range 1,2 times - 2 times longer than the width.
  • the height is in the range 1,3 times - 2 times longer than the width.
  • the height is in the range 1,2 times - 1,8 times longer than the width.
  • the height is in the range 1,3 times - 1,6 times longer than the width.
  • the functional movement restriction device has a height in the range 3cm - 5cm, or a height in the range 3,5cm - 6cm, or a height in the range 4cm - 5cm, or a height in the range 4cm - 6cm.
  • the implantable medical device further comprises a central part, and the at least two parts are configured to be connected to the central part for forming at least a portion of the functional movement restriction device.
  • the central part and the at least two parts are capable of disconnecting from each other, such that the central part and the at least two parts individually can pass through the gastro-intestinal tract.
  • the implantable medical device comprises a movement restriction device configured to be fixated to the stomach wall for hindering movement of the lower esophageal sphincter relative to the thoracic diaphragm.
  • the movement restriction device comprises at least two parts, wherein the parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device.
  • the at least two parts are capable of disconnecting from each other, such that the at least two parts individually can pass through the gastro-intestinal tract.
  • the functional movement restriction device is elongated and has a height, being a longest cross-sectional distance, and a width, being a longest cross-sectional distance perpendicular to the height, and wherein the height is the range 1,2 - 2 times longer than the width.
  • the height is in the range 1,3 - 2 times longer than the width.
  • the height is in the range 1,2 - 1,8 times longer than the width.
  • the height is in the range 1,3 - 1,6 times longer than the width.
  • the functional movement restriction device has a height in the range 3cm - 5cm.
  • the functional movement restriction device has a height in the range 3,5cm - 6cm.
  • the functional movement restriction device has a height in the range 4cm - 5cm.
  • the functional movement restriction device has a height in the range 4cm - 6cm.
  • the implantable medical device may further comprise a central part, and the at least two parts may be configured to be connected to the central part for forming at least a portion of the functional movement restriction device.
  • the central part and the at least two parts may be capable of disconnecting from each other, such that the central part and the at least two parts individually can pass through the gastro-intestinal tract.
  • a surgical method of treating reflux disease is further provided.
  • the surgical method comprises steps of dissecting the fundus at least partially on the posterior side thereof, dissecting the esophagus such that the esophagus is disconnected from the surrounding tissue at least 3cm in a cranial direction from the angle of his, connecting the fundus to the esophagus by: placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus, and placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus.
  • the surgical method further comprises the step of fixating an implantable movement restriction device to the fundus, such that the lower esophageal sphincter is prevented from sliding through the esophageal hiatus.
  • the surgical method step of dissecting the fundus at least partially on the posterior side thereof comprises at least partially freeing the fundus from at least one of the gastrophrenic ligament and the gastrosplenic ligament.
  • the step of dissecting the fundus at least partially on the posterior side thereof may comprise dissecting the fundus at least 0,5 cm posterior to a coronal plane intersecting a most cranial point of the fundus, or dissecting the fundus at least partially on the posterior side thereof at least 1 cm posterior to a coronal plane intersecting a most cranial point of the fundus.
  • the surgical method step of dissecting the fundus at least partially on the posterior side thereof may comprise dissecting the fundus at least 0,5 cm posterior to the most anterior fixation point of the gastrophrenic ligament on the fundus, or at least 1 cm posterior to the most anterior fixation point of the gastrophrenic ligament on the fundus.
  • the surgical method step of dissecting the fundus at least partially on the posterior side thereof comprises dissecting the fundus at least 0,5 cm posterior to an extension of the greater curvature of the stomach in the region of the fundus, or at least 1 cm posterior to an extension of the greater curvature of the stomach in the region of the fundus.
  • the surgical method step of dissecting the esophagus comprises dissecting the esophagus such that the esophagus is disconnected from the surrounding tissue at least 4 cm in a cranial direction from the angle of his, preferably at least 5 cm in a cranial direction from the angle of his and most preferably at least 6 cm in a cranial direction from the angle of his.
  • the surgical method step of dissecting the esophagus such that the esophagus is disconnected from the surrounding tissue comprises dissecting the esophagus into mediastinum.
  • the step of dissecting the esophagus into mediastinum may comprise dissecting the esophagus into mediastinum such that the esophagus is disconnected from the surrounding tissue at least 1 cm in a cranial direction from the distal edge of the esophageal hiatus, preferably at least 2 cm in a cranial direction from the distal edge of the esophageal hiatus and most preferably at least 3 cm in a cranial direction from the distal edge of the esophageal hiatus.
  • the step of dissecting the esophagus into mediastinum comprises dissecting the esophagus distally from a point 2 cm distally from the esophageal plexus of the vagus nerve, preferably from a point 1 cm distally from the esophageal plexus of the vagus nerve, more preferably from a point 0,5 cm distally from the esophageal plexus of the vagus nerve.
  • the step of dissecting the esophagus comprises freeing the esophagus from the crus muscles.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing at least two continuous sutures connecting the fundus to the esophagus, on the sinister- posterior side of the esophagus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing at least two continuous sutures connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus.
  • At least one of starting and ending of the continuous sutures may be performed in the serosa of the stomach wall for securing the sutures to the serosa of the stomach wall.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing at least two lateral sutures substantially along a cranial-caudal axis, on the sinister- posterior side of the esophagus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing at least two lateral sutures substantially along a cranial-caudal axis, on the sinister- anterior side of the esophagus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the at least two posterior sutures or staplers at least 0,5 cm posterior to a coronal plane intersecting a most cranial point of the fundus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the at least two anterior sutures or staplers at least 0,5 cm anterior from the coronal plane intersecting the most cranial point of the fundus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the most caudal suture or stapler at least 0,5 cm from the angle of His.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the most caudal suture or stapler at least 0,5 cm from the angle of His.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the most caudal suture or stapler at least 1,5 cm from the angle of His.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the most caudal suture or stapler at least 1,5 cm from the angle of His.
  • the surgical method step of placing the most caudal suture or stapler of the at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus at least 0,5 cm from the angle of His and placing the most caudal suture or stapler of the at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus at least 1,5 cm from the angle of His.
  • the surgical method step of placing the most caudal suture or stapler of the at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus at least 1,5 cm from the angle of His and placing the most caudal suture or stapler of the at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus at least 0,5 cm from the angle of His.
  • the surgical method step of connecting the fundus to the esophagus further comprises placing at least one central suture or stapler on a cranial -caudal axis extending between the at least two posterior sutures or staplers and the at least two anterior sutures or staplers.
  • the step of placing at least one central suture or stapler on a cranial-caudal axis may comprise placing at least one central suture or stapler being disconnected from the at least two anterior sutures or staplers and from the at least two posterior sutures or staplers, for maintaining the possibility of radial expansion the esophagus for limiting the disk of dysphagia.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus, and placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus comprises using an at least partially barbed suture.
  • the step of fixating the implantable movement restriction device to the fundus may comprise placing continuous purse-string roof sutures in the region of the greater curvature of the stomach, in the region of the fundus, such that the stomach tissue can be contracted by pulling the ends of the purse-string sutures.
  • the step of placing roof sutures may comprise placing at least one of the continuous purse-string roof sutures at least 1 cm behind the greater curvature of the stomach, in the region of the fundus.
  • the step of placing the continuous purse-string roof sutures may comprise placing the continuous purse -string roof sutures using an at least partially un-barbed suture.
  • the surgical method step of placing the continuous purse-string roof sutures may comprise starting or ending the continuous purse-string roof sutures at least 0,5 cm from the esophagus.
  • the surgical method step of placing the continuous purse-string roof sutures may comprise placing the continuous purse-string roof sutures using a suture ending with a loop, such that the suture can be drawn through the loop for contracting the stomach tissue.
  • the step of fixating the implantable movement restriction device to the fundus may comprise inserting the implantable movement restriction device into the abdomen of the patient.
  • the step of inserting the implantable movement restriction device into the abdomen of the patient may comprise inserting the implantable movement restriction device into the abdomen of the patient using an insertion instrument having an elongated abdominal portion.
  • the surgical method step of fixating the implantable movement restriction device to the fundus may comprise pushing the implantable movement restriction device into the fundus in a cranial-dorsal direction using the instrument having the elongated abdominal portion.
  • the step of pushing the implantable movement restriction device into the fundus in a dorsal-cranial direction using the instrument having the elongated abdominal portion may comprise pushing the implantable movement restriction device into the fundus in a dorsal-cranial direction using the instrument such that a portion of the implantable medical device ends up dorsal to the roof sutures for placing the movement restriction device in the fundus for facilitating the subsequent invagination in a high-up in fundus position.
  • the step of fixating the implantable movement restriction device to the fundus comprises placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device.
  • the step of placing continuous purse-string floor sutures in the region of the caudal end of the implantable movement restriction device may comprise placing at least two of the continuous purse-string floor sutures following an arc. In cases when the at least two continuous purse-string floor sutures are placed following an arc the continuous purse-string floor sutures may be placed following an arc below the elongated abdominal portion of the instrument holding the implantable movement restriction device.
  • the step of placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device may comprise placing the continuous purse-string base sutures such that the continuous purse-string base sutures forms a closed curve.
  • the step of fixating the implantable movement restriction device to the fundus may comprise placing at least one suture or stapler from stomach wall to stomach wall above the elongated abdominal portion of the instrument holding the implantable movement restriction device.
  • the step of placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device may comprise placing one of the continuous purse-string base sutures from stomach wall to stomach wall above the elongated abdominal portion of the instrument holding the implantable movement restriction device.
  • the step of fixating the implantable movement restriction device to the fundus may comprise releasing the elongated abdominal portion of the instrument from the implantable movement restriction device.
  • the step of fixating the implantable movement restriction device to the fundus may comprise placing at least one suture or stapler from stomach wall to stomach wall in the region from which the elongated abdominal portion of the instrument was removed, for closing the hole through which the elongated abdominal portion of the instrument passed.
  • the step of placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device may comprise placing continuous purse-string base sutures using an at least un-barbed suture for enabling the contraction and relaxation of the stomach wall during the surgical procedure.
  • the step of fixating the implantable movement restriction device to the fundus comprises contracting a first portion of the stomach wall by pulling on the purse-string roof sutures and contracting a second portion of the stomach wall by pulling on the purse -string base sutures.
  • the implantable movement restriction device may thus be fixated in the stomach wall between the first contracted portion and the second contracted portion.
  • the surgical method according to any one of the preceding embodiments may further comprise the step of fixating the implantable movement restriction device to the fundus by invaginating the implantable movement restriction device in the fundus wall from the outside thereof.
  • the step of invaginating the implantable movement restriction device in the fundus wall from the outside thereof may comprise placing at least two sutures or staplers from stomach wall to stomach wall for connecting stomach wall to stomach wall around the implantable movement restriction device and thereby enclose the implantable movement restriction device in a pouch formed by the stomach wall of the fundus.
  • the step of invaginating the implantable movement restriction device may comprise ending the invagination by fixating the suture to the serosa of the stomach wall for long term fixation.
  • the step of fixating the implantable movement restriction device to the fundus comprises contracting the first portion of the stomach wall by pulling on the purse-string roof sutures and determining the length of the loop formed by the purse-string roof sutures by securing the purse-string roof sutures to the serosa of the stomach wall.
  • a surgical method of treating reflux disease comprises the steps of connecting the fundus to the esophagus by: placing at least two posterior lateral sutures or staplers substantially along a cranial -caudal axis on the sinister-posterior side of the esophagus, connecting the fundus to the esophagus on the sinister-posterior side of the esophagus, and placing at least two anterior lateral sutures or staplers substantially along a cranial-caudal axis on the sinister- posterior side of the esophagus, connecting the fundus to the esophagus on the sinister-posterior side of the esophagus.
  • the surgical method further comprises the step of fixating an implantable movement restriction device to the fundus, such that the lower esophageal sphincter is prevented from sliding through the esophageal hiatus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing at least two continuous sutures connecting the fundus to the esophagus, on the sinister- posterior side of the esophagus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing at least two continuous sutures connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus.
  • At least one of starting and ending of the continuous sutures may be performed in the serosa of the stomach wall for securing the sutures to the serosa of the stomach wall.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing at least two lateral sutures substantially along a cranial-caudal axis, on the sinister- posterior side of the esophagus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing at least two lateral sutures substantially along a cranial-caudal axis, on the sinister- anterior side of the esophagus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the at least two posterior sutures or staplers at least 0,5 cm posterior to a coronal plane intersecting a most cranial point of the fundus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the at least two anterior sutures or staplers at least 0,5 cm anterior from the coronal plane intersecting the most cranial point of the fundus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the most caudal suture or stapler at least 0,5 cm from the angle of His.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the most caudal suture or stapler at least 0,5 cm from the angle of His.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the most caudal suture or stapler at least 1,5 cm from the angle of His.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the most caudal suture or stapler at least 1,5 cm from the angle of His.
  • the surgical method step of placing the most caudal suture or stapler of the at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus at least 0,5 cm from the angle of His and placing the most caudal suture or stapler of the at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus at least 1,5 cm from the angle of His.
  • the surgical method step of placing the most caudal suture or stapler of the at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus at least 1,5 cm from the angle of His and placing the most caudal suture or stapler of the at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus at least 0,5 cm from the angle of His.
  • the surgical method step of connecting the fundus to the esophagus further comprises placing at least one central suture or stapler on a cranial -caudal axis extending between the at least two posterior sutures or staplers and the at least two anterior sutures or staplers.
  • the step of placing at least one central suture or stapler on a cranial-caudal axis may comprise placing at least one central suture or stapler being disconnected from the at least two anterior sutures or staplers and from the at least two posterior sutures or staplers, for maintaining the possibility of radial expansion the esophagus for limiting the disk of dysphagia.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus, and placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus comprises using an at least partially barbed suture.
  • a surgical method of treating reflux disease comprises the steps of dissecting the fundus at least partially on the posterior side thereof, wherein the step of dissecting the fundus at least partially on the posterior side thereof comprises at least partially freeing the fundus from at least one of the gastrophrenic ligament and the gastrosplenic ligament, and fixating an implantable movement restriction device to the fundus, such that the lower esophageal sphincter is prevented from sliding through the esophageal hiatus.
  • the step of dissecting the fundus at least partially on the posterior side thereof may comprise dissecting the fundus at least 0,5 cm posterior to a coronal plane intersecting a most cranial point of the fundus or dissecting the fundus at least partially on the posterior side thereof at least 1 cm posterior to a coronal plane intersecting a most cranial point of the fundus.
  • the surgical method step of dissecting the fundus at least partially on the posterior side thereof may comprise dissecting the fundus at least 0,5 cm posterior to the most anterior fixation point of the gastrophrenic ligament on the fundus, or at least 1 cm posterior to the most anterior fixation point of the gastrophrenic ligament on the fundus.
  • the surgical method step of dissecting the fundus at least partially on the posterior side thereof comprises dissecting the fundus at least 0,5 cm posterior to an extension of the greater curvature of the stomach in the region of the fundus, or at least 1 cm posterior to an extension of the greater curvature of the stomach in the region of the fundus.
  • the step of fixating the implantable movement restriction device to the fundus may comprise placing continuous purse-string roof sutures in the region of the greater curvature of the stomach, in the region of the fundus, such that the stomach tissue can be contracted by pulling the ends of the purse-string sutures.
  • the step of placing roof sutures may comprise placing at least one of the continuous purse-string roof sutures at least 1 cm behind the greater curvature of the stomach, in the region of the fundus.
  • the step of placing the continuous purse-string roof sutures may comprise placing the continuous purse -string roof sutures using an at least partially un-barbed suture.
  • the surgical method step of placing the continuous purse-string roof sutures may comprise starting or ending the continuous purse-string roof sutures at least 0,5 cm from the esophagus.
  • the surgical method step of placing the continuous purse-string roof sutures may comprise placing the continuous purse-string roof sutures using a suture ending with a loop, such that the suture can be drawn through the loop for contracting the stomach tissue.
  • the step of fixating the implantable movement restriction device to the fundus may comprise inserting the implantable movement restriction device into the abdomen of the patient.
  • the step of inserting the implantable movement restriction device into the abdomen of the patient may comprise inserting the implantable movement restriction device into the abdomen of the patient using an insertion instrument having an elongated abdominal portion.
  • the surgical method step of fixating the implantable movement restriction device to the fundus may comprise pushing the implantable movement restriction device into the fundus in a cranial-dorsal direction using the instrument having the elongated abdominal portion.
  • the step of pushing the implantable movement restriction device into the fundus in a dorsal-cranial direction using the instrument having the elongated abdominal portion may comprise pushing the implantable movement restriction device into the fundus in a dorsal-cranial direction using the instrument such that a portion of the implantable medical device ends up dorsal to the roof sutures for placing the movement restriction device in the fundus for facilitating the subsequent invagination in a high-up in fundus position.
  • the step of fixating the implantable movement restriction device to the fundus comprises placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device.
  • the step of placing continuous purse-string floor sutures in the region of the caudal end of the implantable movement restriction device may comprise placing at least two of the continuous purse-string floor sutures following an arc. In cases when the at least two continuous purse-string floor sutures are placed following an arc the continuous purse-string floor sutures may be placed following an arc below the elongated abdominal portion of the instrument holding the implantable movement restriction device.
  • the step of placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device may comprise placing the continuous purse-string base sutures such that the continuous purse-string base sutures forms a closed curve.
  • the step of fixating the implantable movement restriction device to the fundus may comprise placing at least one suture or stapler from stomach wall to stomach wall above the elongated abdominal portion of the instrument holding the implantable movement restriction device.
  • the step of placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device may comprise placing one of the continuous purse-string base sutures from stomach wall to stomach wall above the elongated abdominal portion of the instrument holding the implantable movement restriction device.
  • the step of fixating the implantable movement restriction device to the fundus may comprise releasing the elongated abdominal portion of the instrument from the implantable movement restriction device.
  • the step of fixating the implantable movement restriction device to the fundus may comprise placing at least one suture or stapler from stomach wall to stomach wall in the region from which the elongated abdominal portion of the instrument was removed, for closing the hole through which the elongated abdominal portion of the instrument passed.
  • the step of placing continuous purse-string base sutures in the region of the caudal end of the implantable movement restriction device may comprise placing continuous purse-string base sutures using an at least un-barbed suture for enabling the contraction and relaxation of the stomach wall during the surgical procedure.
  • the step of fixating the implantable movement restriction device to the fundus comprises contracting a first portion of the stomach wall by pulling on the purse-string roof sutures and contracting a second portion of the stomach wall by pulling on the purse -string base sutures.
  • the implantable movement restriction device may thus be fixated in the stomach wall between the first contracted portion and the second contracted portion.
  • the surgical method according to any one of the preceding embodiments may further comprise the step of fixating the implantable movement restriction device to the fundus by invaginating the implantable movement restriction device in the fundus wall from the outside thereof.
  • the step of invaginating the implantable movement restriction device in the fundus wall from the outside thereof may comprise placing at least two sutures or staplers from stomach wall to stomach wall for connecting stomach wall to stomach wall around the implantable movement restriction device and thereby enclose the implantable movement restriction device in a pouch formed by the stomach wall of the fundus.
  • the step of invaginating the implantable movement restriction device may comprise ending the invagination by fixating the suture to the serosa of the stomach wall for long term fixation.
  • the step of fixating the implantable movement restriction device to the fundus comprises contracting the first portion of the stomach wall by pulling on the purse-string roof sutures and determining the length of the loop formed by the purse-string roof sutures by securing the purse-string roof sutures to the serosa of the stomach wall.
  • a surgical method of treating reflux disease comprises the steps of: dissecting the esophagus such that the esophagus is disconnected from the surrounding tissue at least 3cm in a cranial direction from the angle of his and fixating an implantable movement restriction device to the fundus, such that the lower esophageal sphincter is prevented from sliding through the esophageal hiatus.
  • the surgical method step of dissecting the esophagus comprises dissecting the esophagus such that the esophagus is disconnected from the surrounding tissue at least 4 cm in a cranial direction from the angle of his, preferably at least 5 cm in a cranial direction from the angle of his and most preferably at least 6 cm in a cranial direction from the angle of his.
  • the surgical method step of dissecting the esophagus such that the esophagus is disconnected from the surrounding tissue comprises dissecting the esophagus into mediastinum.
  • the step of dissecting the esophagus into mediastinum may comprise dissecting the esophagus into mediastinum such that the esophagus is disconnected from the surrounding tissue at least 1 cm in a cranial direction from the distal edge of the esophageal hiatus, preferably at least 2 cm in a cranial direction from the distal edge of the esophageal hiatus and most preferably at least 3 cm in a cranial direction from the distal edge of the esophageal hiatus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing at least two continuous sutures connecting the fundus to the esophagus, on the sinister- posterior side of the esophagus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing at least two continuous sutures connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus.
  • At least one of starting and ending of the continuous sutures may be performed in the serosa of the stomach wall for securing the sutures to the serosa of the stomach wall.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing at least two lateral sutures substantially along a cranial-caudal axis, on the sinister- posterior side of the esophagus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing at least two lateral sutures substantially along a cranial-caudal axis, on the sinister- anterior side of the esophagus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the at least two posterior sutures or staplers at least 0,5 cm posterior to a coronal plane intersecting a most cranial point of the fundus.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the at least two anterior sutures or staplers at least 0,5 cm anterior from the coronal plane intersecting the most cranial point of the fundus.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the most caudal suture or stapler at least 0,5 cm from the angle of His.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the most caudal suture or stapler at least 0,5 cm from the angle of His.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus comprises placing the most caudal suture or stapler at least 1,5 cm from the angle of His.
  • the surgical method step of placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus comprises placing the most caudal suture or stapler at least 1,5 cm from the angle of His.
  • the surgical method step of placing the most caudal suture or stapler of the at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus at least 0,5 cm from the angle of His and placing the most caudal suture or stapler of the at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus at least 1,5 cm from the angle of His.
  • the surgical method step of placing the most caudal suture or stapler of the at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus at least 1,5 cm from the angle of His and placing the most caudal suture or stapler of the at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-anterior side of the esophagus at least 0,5 cm from the angle of His.
  • the surgical method step of connecting the fundus to the esophagus further comprises placing at least one central suture or stapler on a cranial -caudal axis extending between the at least two posterior sutures or staplers and the at least two anterior sutures or staplers.
  • the step of placing at least one central suture or stapler on a cranial-caudal axis may comprise placing at least one central suture or stapler being disconnected from the at least two anterior sutures or staplers and from the at least two posterior sutures or staplers, for maintaining the possibility of radial expansion the esophagus for limiting the disk of dysphagia.
  • the surgical method step of placing at least two posterior sutures or staplers, connecting the fundus to the esophagus, on the sinister-posterior side of the esophagus, and placing at least two anterior sutures or staplers, connecting the fundus to the esophagus, on the sinister- anterior side of the esophagus comprises using an at least partially barbed suture.
  • a surgical kit for performing a surgical procedure for treating reflux disease is further provided.
  • the surgical could include the movement restriction device according to any of the embodiments described herein.
  • the kit surgical kit further comprises a lubricant for use with the implantable movement restriction device, at least one partially barbed suture comprising a barbed portion and a portion without barbs, wherein the portion without barbs is at least 2cm long, or at least 3cm long, and at least one suture without barbs.
  • the surgical kit further comprises at least one barbed suture.
  • the at least one partially barbed suture comprises a loop for use in fixating the at least one partially barbed suture.
  • the at least one partially barbed suture comprises at least one of the following materials: PTFE, GoreTex®, PP, and Polyester.
  • the at least one barbed suture comprises at least one of the following materials: PTFE, GoreTex®, PP, and Polyester.
  • the at least one suture without barbs comprises at least one of the following materials: PTFE, GoreTex®, PP, and Polyester.
  • At least one of: the partially barbed suture, the at least one barbed suture, and the at least one suture without barbs, is a monofdament suture.
  • At least one of: the partially barbed suture, the at least one barbed suture, and at least one suture without barbs is a braided suture.
  • the suture comprises a coating.
  • the movement restriction device comprises at least two parts, wherein the parts are configured to be connected to each other for forming at least a portion of a functional movement restriction device, and the at least two parts are capable of disconnecting from each other, such that the at least two parts individually can pass through the gastro-intestinal tract.
  • the surgical kit further comprises a central part, wherein the at least two parts are configured to be connected to the central part for forming at least a portion of the functional movement restriction device, the central part and the at least two parts are capable of disconnecting from each other, such that the central part and the at least two parts individually can pass through the gastro-intestinal tract.
  • FIGs 1-11 are schematic views of various examples of apparatuses for treating reflux disease, wherein the apparatuses are implanted in the body of the patient.
  • Figures 12-18J are schematic views of further examples of apparatuses for treating reflux disease.
  • Figures 19A and 19B are schematic views of an example of an apparatus for treating reflux disease, wherein the apparatus is implanted in the body of the patient.
  • Figure 19A shows the apparatus in an expanded state and figure 19B shows the apparatus in a constricting state.
  • Figures 20A-21 are schematic views of various examples of apparatuses for treating reflux disease.
  • Figures 22A-23K are schematic views of various examples of methods for treating reflux disease and/or implanting an apparatus for treating reflux disease.
  • Figures 24-27 are schematic views of various examples of apparatuses for at least partly encircling the esophagus to treat reflux disease.
  • Figure 28 schematically illustrates how an apparatus for treating reflux disease can be implanted in the patient.
  • Figures 29-38B are schematic views of various examples of apparatuses for treating reflux disease.
  • Figure 39A is a schematic cross-section illustrating the anatomy of the stomach of a human patient.
  • Figure 39B is a schematic illustration of the anatomy of a human patient.
  • Figure 39B’ is a schematic illustration of the anatomy of the stomach of a human patient.
  • Figures 39C-39P are schematic views of various examples of apparatuses and methods for treating reflux disease.
  • Figures 39Q-39V’ are schematic cross-sectional views of various examples of movement restrictions devices for the treatment of reflux disease.
  • Figures 39W and 39W’ are schematic cross-sectional views of an apparatus for the treatment of reflux disease and obesity.
  • Figures 39X - 39Z’ are schematic views of apparatus for the treatment of reflux disease and obesity shown in further detail.
  • Figures 39AA and 39AB are schematic views of two examples of apparatuses and methods for treating reflux disease.
  • Figure 39AC is a schematic view of an instrument for use in a method for implanting a movement restriction device.
  • Figures 39AD - 39AG are schematic views of apparatus for the treatment of reflux disease shown in further detail.
  • Figures 39AH - 39AJ are schematic views of various examples of apparatuses and methods for treating reflux disease.
  • Figures 40AA is a schematic view of an apparatus for treating reflux disease, when the apparatus is implanted in the body of the patient.
  • Figures 40AB - 40AD are schematic views of an apparatuses for treating reflux disease in further detail.
  • Figures 40AE - 40AH are schematic views of details of distance elements of apparatuses for treating reflux disease.
  • Figures 40BA - 40ME are schematic views of an apparatuses for treating reflux disease in further detail.
  • Figures 40N - 40N shows a schematic view of an implanted apparated for treating reflux disease, when the movement restriction device of the apparatus migrates through the stomach wall in its invaginated position.
  • Figures 400 - 40SE’ shows schematic views of implantable medical devices for the treatment of reflux and/or obesity.
  • Figures 40TA - 40TC schematically shows the insertion of parts of implantable medical devices shown in figs. 40SA - 40SE’” for the treatment of reflux and/or obesity, as well as an instrument for use in such insertion.
  • Figures 40UA - 40UI’ schematically shows alternative shapes of implantable medical devices for the treatment of reflux and/or obesity and shapes of parts of implantable medical devices for the treatment of reflux and/or obesity.
  • RECTIFIED SHEET (RULE 91)
  • Figures 41A-D show various examples of electrode arrangements for electrically stimulating muscle tissue of the patient.
  • Figures 42A-42B illustrate a pulsed signal for electrically stimulating muscle tissue.
  • Figures 43-45 are schematic illustrations of systems for treating reflux disease.
  • Figure 46 shows a human patient in cross section when a system for treating reflux disease has been implanted.
  • Figures 47A-B show a cross-sectional view of an implantable remote unit for powering an implantable medical device.
  • Figure 48 shows an exploded cross-sectional view of an implantable remote unit for powering an implantable medical device.
  • Figures 49A-C show a detailed cross-sectional view of a first unit of an implantable remote unit for powering an implantable medical device
  • Figures 50A-B show alternative embodiments of connecting portions for an implantable remote unit.
  • Figures 51A-B show, schematically, a kit of components forming an implantable remote unit.
  • Figure 52A-B show a detailed cross-sectional view of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figure 53 shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figure 54 shows a perspective elevated view from the right of a portion of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figure 55 shows a perspective elevated view from the right of a portion of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figures 56-57 show cross-sectional plain side views of implantable remote units for powering an implantable medical device.
  • Figures 58A-D show cross-sectional plain side views of embodiments of an implantable remote unit for powering an implantable medical device.
  • Figures 59A-K, 59M, 59N, 59P and 59Q show embodiments of an implantable remote unit for powering an implantable medical device.
  • Figure 60 shows a perspective elevated view from the right of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figure 61 shows a plain top view of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figures 62A-B show, schematically, plain top views of two embodiments of implantable remote units for powering implantable medical devices.
  • Figures 63A-C illustrate three stages of insertion and fixation of an embodiment of an implantable remote unit for powering an implantable medical device.
  • FIG. 64 shows a detailed cross-sectional view of an embodiment of an implantable remote unit for powering an implantable medical device.
  • Figures 65A-E and 66A-N illustrate communication systems according to some embodiments.
  • the boundary of an element is to be understood as the outer periphery that encompasses all of the points of the element without creating recesses. It can be illustrated by the surface created by placing the element in a plastic bag and tightening the plastic around the element such that the surface of the plastic bag takes the shortest route between points in the periphery of the element which are separated by a recess.
  • Functional implantable medical device / functional movement restriction device is to be understood as the shape and state which the functional implantable medical device / functional movement restriction device is in when it can perform its intended function.
  • a functional implantable medical device configured to be assembled from a plurality of parts is not functional until assembled.
  • implantable medical devices described herein may function as a movement restriction device and/or as an obesity treatment devices.
  • FIG. 1 is a schematic illustration of an apparatus 100 according to some embodiments of the present disclosure.
  • the apparatus 100 may be used for treatment of a human patient suffering from gastroesophageal reflux disease (GERD), also referred to as reflux disease.
  • the apparatus 100 may comprise a movement restriction device 110 configured to be implanted in the stomach 10 for hindering the cardia 22 from sliding through the diaphragm opening 32, and an electrode arrangement 150 for stimulating and exercising muscle tissue of the stomach 10 to improve the conditions for long-term implantation.
  • GUD gastroesophageal reflux disease
  • the movement restriction device 110 may be arranged to rest against a fundus wall portion 14 of the stomach 10.
  • the movement restriction device 110 is arranged to rest against the outside of the stomach wall.
  • the movement restriction device 110 may in alternative examples and implementations be arranged to rest against the inside of the stomach wall.
  • the movement restriction device 110 may have a shape and size that allows it to be fully or at least partly invaginated by the fundus wall portion 14. This may be achieved by forming a pouch or recess in the fundus wall portion 14 and at least partly closing the opening of the pouch or recess so as to hinder the movement restriction device 110 to be removed from the fundus wall portion 14.
  • the invagination by the fundus wall portion 14 allows for the movement restriction device 110 to be implanted at a position between the patient’s diaphragm 30 and a lower portion of the fundus wall 12, such that movement of the cardia 22 towards the diaphragm 30 is restricted.
  • the cardia 22 may be hindered from sliding up towards, and possibly through, the diaphragm opening 32 into the patient’s thorax, and the supporting pressure against the cardiac sphincter 26 exerted from the abdomen can therefore be maintained.
  • the movement restriction device 110 may be coupled, of affixed to the esophagus 20 at a position above the cardiac sphincter 26.
  • the affixation of the movement restriction device 110 may preferably be of an indirect nature, achieved by affixing a part of the fundus 12 to the esophagus 20 such that the invagination can act as a mechanical stop against the diaphragm 30 when the esophagus is moving upwards through the diaphragm opening 32.
  • the movement restriction device 110 may be implanted such that a part of the fundus is arranged between the movement restriction device 110 and the outside of the esophagus 20.
  • the shape and size of the movement restriction device 110 is an important factor for allowing the invagination to act as a mechanical stop against the diaphragm 30.
  • the movement restriction device 110 may have a size and shape that allows for the invagination to be sufficiently large to hinder the fundus wall portion 14 to slide through the diaphragm opening 32 together with the cardia.
  • the movement restriction device 110 may have a size and shape that allows it to be invaginated by the fundus 12 of the stomach without causing an unjustified reduction of the total volume of the stomach cavity.
  • the movement restriction device 110 may at the same time be sufficiently small to allow it to generate a mechanical stop against the diaphragm muscle while leaving the food passageway substantially intact and unaffected.
  • the movement restriction device 110 disclosed herein advantageously allows for the symptoms of reflux disease to be addressed while reducing the risk for compressing the food passageway.
  • the movement restriction device 110 may have a substantially smooth outer surface. Any comers, edges, joints, or seams may be rounded so as not to damage or irritate the tissue against which the movement restriction device 110 may rest when implanted.
  • the movement restriction device 110 may have a rounded shape, for example conforming to a sphere, a spheroid, or an egg.
  • the minimum width of the movement restriction device 110, as measured from side to side, may in some examples be 30 mm or larger, such as 40 mm or larger. Additionally, or alternatively a minimum outer circumference of the movement restriction device 110 may be 150 mm or less, such as 130 mm or less, such as 110 mm or less.
  • the minimum outer circumference may be 90 mm or less, such as 70 mm or less, such as 50 mm or less, and such that 30 mm or less. It will however be appreciated that the dimensions of the movement restriction device may vary according to the anatomy of the actual individual into which the movement restriction device 110 is to be implanted. The size and shape of the movement restriction device 110 may be adapted to the individual patient to allow for the invagination to act as a mechanical stop as outlined above and thereby have an effect on reflux disease.
  • the movement restriction device 110 may be formed of a biocompatible material that is suitable for long-term implantation in the human body. Alternatively, or additionally, the outer surface of the movement restriction device 110 may be provided with a layer or coating of such a material.
  • biocompatible materials include titanium or a medical grade metal alloy, such as medical grade stainless steel.
  • movement restriction device 110 may be made from of 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).
  • UHMWPE Ultra-high- molecular-weight polyethylene
  • PTFE Polytetrafluoroethylene
  • PLA polylactide
  • Movement restriction device 110 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.
  • the movement restriction device may comprise 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,
  • the movement restriction device 110 may according to some examples be configured to be introduced into the patient’s body by means of a gastroscope or an intraluminal instrument, thereby allowing the apparatus 100 to be implanted by means of natural orifice transluminal endoscopic surgery (NOTES).
  • NOTES natural orifice transluminal endoscopic surgery
  • the movement restriction device 110 may have a shape and size allowing it to be introduced and pass through a tubular instrument.
  • the movement restriction device 110 may be configured to change its shape, preferably resiliently, to temporarily assume a smallest width that allows for the movement restriction device 110 to pass through such an instrument.
  • the apparatus 100 may further comprise an electrode arrangement 150 configured to be arranged between the movement restriction device 110 and the stomach wall portion 14 when the apparatus 100 is implanted.
  • the electrode arrangement 150 may be configured to electrically stimulate muscle tissue of the stomach wall portion 14 so as to exercise the muscle tissue and thereby improve the conditions for long term implantation of the movement restriction device 110.
  • the electrode arrangement 14 may comprise at least one electrode element 152, which may be configured to abut the tissue against which the movement restriction device 110 is arranged to rest when implanted and to transmit electrical impulses to the muscle tissue. It is appreciated that the electrode element 152 may be arranged in direct contact with the muscle tissue, or in indirect contact via intermediate tissue such as for example connective tissue or fibrous tissue.
  • the electrode arrangement 150 may be configured to rest against, abut or engage the tissue at least partly surrounding the implanted movement restriction device 110. The interaction between the electrode arrangement 150 and the muscle tissue will be described in greater detail in connection with figures 38-41.
  • the electrode element 152 may be attached directly to an outer surface of the movement restriction device 110, as shown in figure 1. In some examples, however, the electrode element 152 may be arranged on a support, such as a flexible patch, which may be configured to be attached to the medical implant. In further examples the electrode arrangement 150 may be provided as a separate item, physically distinct from the movement restriction device 110.
  • the apparatus 100 may further comprise an implantable energy source 160, which may be configured to supply the electrode arrangement 150 with electrical power for the electrical stimulation of the muscle tissue.
  • the energy source 160 may be integrated in the in the movement restriction device 110 as shown in the present figure, wherein the energy source 160 is placed inside the movement restriction device 110 and electrically connected to the electrode element 152 arranged between the outer surface of the movement restriction device 110 and the fundus wall portion 14.
  • the energy source 160 may in some examples be arranged outside the movement restriction device 110 as well, forming as a separate structural entity that can be implanted in the abdomen or elsewhere, such as subcutaneously.
  • the energy source 160 may comprise a primary cell, i.e., a battery designed to not be recharged.
  • the energy source 160 may comprise a secondary cell designed to be recharged, preferably by means of an external energy source located outside the patient’s body.
  • Various examples of charging of the energy source 160 and powering of the electrode arrangement 150 is described in connection with figures 42-44, together with examples of how to control and operate the electrode arrangement 150.
  • FIG. 2 is a schematic illustration of an apparatus 100 according to some embodiments, which may be similarly configured as the embodiments discussed with reference to figure 1.
  • the apparatus 100 is shown when implanted in a patient to treat reflux disease, and may comprise a movement restriction device 110 and an electrode arrangement 150 for generating an electric signal causing the muscle cells of the fundus wall portion 14 to contract and relax repeatedly.
  • This action, or exercising of the cells by means of the electrode arrangement as shown in figures 1 and 2 has been found to have a positive impact in terms of preventing deterioration and damage of the tissue and help increasing tolerance of the tissue for pressure and mechanical forces generated by the medical implant.
  • the present example differs from the one of figure 1 in that the movement restriction device is coupled to a user interface allowing the patient or persons, such as medical staff, to interact with the apparatus 100. More specifically, the user interface may allow for communication with the implant and/or control of the operation of the implant. It may also comprise means for supplying power to the implant.
  • the user interface may for example comprise a remote unit 140, such as a regulator or a pushbutton, that is connected to the movement restriction device 110 via a communication channel 172 such as a wiring or electrical lead.
  • the remote unit 140 may for example be implanted subcutaneously so as to facilitate access from outside the body. Features and functions of the remote unit 140 is further described with reference to figs. 46 - 64.
  • a user such as the patient himself or a medical staff may interact with the remote unit 140 to regulate or control the electrical stimulation of the muscle tissue.
  • the remote unit 140 may for example be used to initiate or end the stimulation, or to adjust the electrical signal used for the stimulation, as described in connection with figures 38-41.
  • the regulation and control of the electrical stimulation may be provided by a controller 170, which may be arranged within the movement restriction device 110, integrated in the remote unit 140, or implanted elsewhere in the body or arranged external to the body. In case of the controller being arranged outside the body, control signals may be sent to the implanted apparatus via the remote unit 140.
  • a controller may for example comprise an energy source, an electric switch, or an injection port for varying a volume of the movement restriction device, depending on actual circumstances and application of the implant.
  • the electrode arrangement 150 may comprise a plurality of electrode elements 152 distributed over the outer surface of the movement restriction device 110 so as to allow for the tissue abutting the movement restriction device to be electrically stimulated and exercised.
  • Each of the electrode elements 152 may comprise a contact pad, or contact surface, configured to form a junction with the surrounding tissue and which is electrically connected to a circuitry inside the movement restriction device 110.
  • the circuitry may be configured to generate an electrical signal, for example comprising a pattern of electrical pulses, that is transmitted to the muscle tissue via the electrode elements 152.
  • Figure 3 A and 3B illustrates an apparatus 100 for treating reflux disease of a human patient, when implanted in the patient.
  • the apparatus 100 may be similarly configured as the apparatuses disclosed in connection with figures 1-3B, with the difference of an elongated support device 120 which may be configured to at least partly encircle the esophagus 20.
  • the apparatus 100 of figures 3A and 3B may comprise a movement restriction device 110 configured to be implanted to hinder the cardia from sliding through the diaphragm opening as discussed above, and an elongated support device 120 that may be connected to the movement restriction device 110 in a manner that allows the elongated support device 120 to be held in place around the esophagus 20 by the movement restriction device 110.
  • the elongated support device 120 may comprise a mechanical stability, or rigidity that allows for its position relative to the esophagus 20 to be determined mainly by the position and orientation of the movement restriction device 110. Thus, the elongated support device 120 may be implanted and kept in position without having to be secured to the tissue of the esophagus 20. In fig. 3B, the elongated support device 120 incororates a lead for transferring the electrical stimulation signal from the controller 170 to the stimulation elements 152 and optionally to the suppression electrode 150’.
  • the elongated support device 120 travels from the invaginated movement restriction device 110 in the space between the fundus tissue and the esophagus tissue and in a caudal direction to the region of the lower esophageal sphincter.
  • the vertical portion of the elongated support device 120 may be placed between two the suture rows further elaborated on with reference to figs. 22A - 23K.
  • the elongated support device 120 may be formed as a bracket or brace having a shape that allows it to follow at least a part of the outside of the esophagus 20. In some examples, the elongated support device 120 may have a shape conforming to a “C”
  • the elongated support device 120 may be formed of the same material as the movement restriction device 110, or by a different material. Examples of materials include metals and polymers. Further, the elongated support device 120 may comprise a surface layer or coating configured to hinder or reduce growth of fibrotic tissue.
  • the elongated support device 120 may be integrally formed with the movement restriction device 110, such that the movement restriction device 110 and the elongated support device 120 form a single piece.
  • the elongated support device 120 may hence be referred to as a protrusion of the movement restriction device 110, having a length and orientation relative to the body of the movement restriction device 110 that allows for the protrusion to be arranged at least partly around the esophagus 20.
  • the elongated support device 120 and the movement restriction device 110 may be formed as separate pieces that can be joined or attached to each other when implanted.
  • the elongated support device 120 may be formed of a biocompatible material that is suitable for long-term implantation in the human body. Alternatively, or additionally, the outer surface of the elongated support device 120 may be provided with a layer or coating of such a material. Examples of biocompatible materials include titanium or a medical grade metal alloy, such as medical grade stainless steel. In an alternative, support device 120 may be made from of 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).
  • UHMWPE Ultra-high-molecular-weight polyethylene
  • PTFE Polytetrafluoroethylene
  • PLA polylactide
  • the support device 120 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. Further, the support device 120 may comprise 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,
  • the apparatus 100 may further comprise an electrode arrangement 150 comprising an electrode element 154 that is supported by the elongated support device 120, or holder 120 and configured to electrically stimulate muscle tissue of the esophagus 20.
  • the electrode element 154 may hence be arranged between the holder 120 and the outside of the esophagus 20 and configured to transmit an electrical stimulation signal to the tissue of the esophagus 20.
  • the electrical stimulation of the tissue may be similar as the stimulation described above for the movement restriction device 110, i.e., for exercising the muscle tissue to improve the conditions for long term implantation. However, in additional or alternative examples the electrical stimulation may be configured to cause the cardiac sphincter 26 to contract.
  • the apparatus 100 may be provided with an electrode arrangement 150 for electrical stimulation of the muscle tissue close to the implanted movement restriction device 110 and for electrical stimulation of the cardiac sphincter muscle 26.
  • the electrode arrangement 150 may comprise an electrode element 154 for the stimulation of the cardiac sphincter 26 only.
  • the electrode arrangement 150 at the movement restriction device 110 may be optional.
  • the electrode arrangement 150 may comprise at least two electrode elements 154 that are supported by the elongated support device 120 at two different positions of the cardia 22, preferably at opposing sides, so as to allow for the cardiac sphincter 26 to be electrically stimulated.
  • the electrode arrangement 150 may be controlled to alternate between at least two modes, i.e., an operation mode in which the cardiac sphincter 26 is stimulated with electrical energy and a resting mode, in which the cardiac sphincter 26 is not stimulated to allow the muscle tissue to recover.
  • the electrode arrangement 150 may further be operable to apply a suppression signal for suppressing action potentials, which are induced by the electrical stimulation of the tissue at the movement restriction device or the cardiac sphincter, propagating in an antidromic direction, i.e., towards the brain.
  • the suppression signal may be employed to inhibit or block stimulation- induced action potentials from causing undesired responses in the patient when propagating towards the brain.
  • the suppressing signal may for example be delivered to the vagus nerve at a position cranial to the plurality of electrode elements 152 arranged between the holder 120 and the outside of the esophagus 20.
  • an optional suppression electrode 150’ is coupled to the outer wall of the esophagus 20, preferably at a position allowing the suppression signal to be delivered to the vagus nerve.
  • the suppression signal may be a time-varying signal, having a frequency component that varies in the range of 1-10 kHz, such as 2-8 kHz, such as 4-6 kHz, for which the nerve’s capability of conveying action potentials has been observed to be reduced or even eliminated.
  • Frequencies in the range of 1-10 kHz may be considered as relatively high frequencies, compared to the frequencies typically used for the electrical stimulation signal.
  • the electrical stimulation signal has showed to generate an effector response when comprising frequencies in the range of, e.g., 0.1-100 Hz.
  • the electrical stimulation signal may thus be referred to as a low-frequency signal, whereas the suppression signal may be referred to as a high-frequency signal.
  • a substantially unidirectional stimulation may be achieved, in which the effector tissue (such as the tissue at the movement restriction device or the cardiac sphincter) can be stimulated without causing undesired stimulation or responses in tissue cranial to the suppression electrode 150’.
  • the effector tissue such as the tissue at the movement restriction device or the cardiac sphincter
  • the controller 170 is configured to drive the electrode arrangement 150 such that the stimulation signal and the suppression signal are delivered in sequence, with a delay of the suppression signal timed to generally match a conduction velocity of the stimulation signal in the nervous tissue, such as the vagus nerve, between the electrode element(s) 152, 154 delivering the stimulation signal and the suppression electrode 150 delivering the suppression signal.
  • the controller 170 is configured to drive the electrode arrangement 150 such that each of the stimulation signal and the suppression signal is a time-varying signal, wherein the stimulation signal is a low-frequency signal (such as in the range of 0. 1-100 Hz) and the suppression signal is a high-frequency signal (such as in the range of 1-10 kHz).
  • the stimulation electrode element 152, 154 and the suppression electrode 150’ are configured to be arranged spaced apart along a nerve, such as the vagus nerve, and/or along the esophagus. As mentioned above, the suppression electrode 150’ may be arranged cranial to the stimulation electrode element 152, 154.
  • the suppression electrode 150’ may be a patch electrode configured to be attached to a portion of the stomach wall, a portion of the esophagus, and/or the vagus nerve.
  • the suppression electrode 150’ may be arranged in a cuff arranged to at least partly encircle the esophagus and to cause the suppression electrode 150’ to touch the tissue of the esophagus.
  • a sensor device may be provided, which is configured to generate a sensor signal indicating action potentials propagating in the vagus nerve, wherein the action potentials are induced by the electrical stimulation signal.
  • the controller may be configured to generate the suppression signal based on the sensor signal, thereby allowing the suppression signal to be adapted or fine-tuned based on the action potentials propagating in the nerve.
  • a sensor device may be provided to detect the patient swallowing.
  • the sensor device may be configured to sense actions potentials generated by pacemaker cells of the muscle tissue.
  • the stimulation controller (170) is then configured to control the electrical simulation based at least partly on the sensed action potentials, such that the electrical stimulation seizes when the patient swallows.
  • the sensor may sense swallowing by sensing other types of parameters.
  • the sensor could comprise a motility sensor, which could be a piezo electric or piezo resistive motility sensor, or an accelerometer.
  • a acoustic sensor such as a microphone, may be used to sense the patient swallowing by picking up the sound generated by the patient swallowing.
  • an optical sensor may be used for sensing the opacity alteration over the esophagus as food passes.
  • a strain sensor could also be used for sensing the expansion of the esophagus as food passes.
  • the sensor may be an EIM (Electrical Impedance Myography) sensor configured to measure a change in electrical impedance in the tissue of the lower esofageal sphincter or in the esophagus tissue to detect the patient swallowing or to detect the muscles response to the stimulation signal.
  • the electromyographic sensor may be configured to measure an electric activity in the the tissue of the lower esofageal sphincter or in the esophagus tissue.
  • the sensor device may also or instead comprise an electric impedance sensor configured to measure a change in electrical impedance in the the tissue of the lower esofageal sphincter or in the esophagus tissue.
  • the sensor electrode may be configured to be arranged at the tissue of the lower esofageal sphincter or in the esophagus tissue and may further comprise a reference electrode.
  • the sensor device or controller (170) may be configured to generate the sensor signal based on an electrical interaction between the sensor electrode and the reference electrode.
  • the sensor device may in the alternative be configured to measure mechanical movement in the lower esofageal sphincter or in the esophagus tissue in response to the stimulation signal.
  • the sensor device may comprise a strain gauge configured to measure a contraction or relaxation of the effector tissue in response to the stimulation signal.
  • swallowing may be measured by measuring parameters related to a heart rate of the patient, a blood pressure of the patient or a rate of respiration of the patient.
  • the response from the sensor may be determined by the controller (170) which may be configured to determine a response measure based on the sensor signal, the response measure being indicative of the response in the lower esofageal sphincter or in the esophagus tissue.
  • the controller may have a be configured to compare the response measure with a predetermined reference measure; and control the stimulation device to: increase an intensity of the stimulation signal in response to the response measure being below the reference measure, and reduce the intensity of the stimulation signal in response to the response measure exceeding the reference measure.
  • the controller (170) may be configured to: increase the intensity of the stimulation signal by increasing at least one of a frequency, current amplitude, and voltage amplitude of the stimulation signal; and reduce the intensity of the stimulation signal by reducing at least one of the frequency, current amplitude, and voltage amplitude of the stimulation signal.
  • the predetermined reference measure may be based on a previous measurement of the effector response in the patient.
  • the apparatus 100 may further comprise a user interface, comprising a remote unit 140 and a communication channel 172 which may be similarly configured to the example described above in connection with figure 2.
  • the user interface may allow for the patient, or medical staff, to choose when the electrode arrangement 150 should be in the operation mode and when it should be in the resting mode. For example, for some patients is may be sufficient to keep the stimulation temporarily “on” when the patient experiences reflux symptoms, such as at night the patient is lying down, whereas other patients may need the cardiac sphincter 26 to be stimulated continuously, with the exception of when eating.
  • the user interface may further allow for the power of the electrical signal to be adjusted over time.
  • the power used for the stimulation may be increased to compensate for an increased resistance at the junction between the electrode element 154 and the tissue caused by formation of fibrotic tissue.
  • the apparatus 100 may comprise an energy source 160 for supplying the electrode arrangement 150 with electrical power.
  • the energy source 160 may be implantable, for example at a location outside the movement restriction device 110, such as subcutaneously as illustrated in figure 3.
  • the communication channel 172 may hence be configured to convey the electrical power, i.e., the electrical signal, from the energy source 160 to electrode arrangement 150.
  • the communication channel 172 may for example comprise an electrical conductor for electrically connecting the electrode arrangement 150 of the elongated support device 120 (and, optionally, the movement restriction device 110) with the energy source 160.
  • the movement restriction device 110 may be implanted in the fundus wall portion 14 is a number of different ways, and that figures 1-3 are merely illustrative examples.
  • the movement restriction device 110 is invaginated in the fundus wall portion 14 from outside the stomach.
  • a plurality of stomach-to-stomach sutures or staples may be applied to maintain the invagination intact and the movement restriction device 110 in the desired position relative to the cardia 22 and the diaphragm 30 of a standing patient. This allows for a growth of fibrotic tissue for keeping the invagination intact over time.
  • an affixation may be provided between the fundus wall portion 14 and the diaphragm 30, and/or the fundus wall portion 14 and the esophagus 20 as illustrated in figure 4.
  • the movement restriction device 110 depicted in figure 4 may be similarly configured as the embodiments discussed in connection with figures 1-3, and figure 4 hence discloses a movement restriction device 110 implanted in in the fundus 12 and arranged at a position above the cardia 22 so as to provide a mechanical stop reducing the symptoms of reflux disease.
  • the movement restriction device 110 may also comprise an electrode arrangement 150 for electrically stimulating and exercising the muscle tissue affected by the implanted device 110, as described above.
  • the movement restriction device 110 is invaginated from the inside of the stomach 10, instead of from the outside of the stomach 10.
  • the movement restriction device 110 is hence adapted to rest against a portion of the inside wall of the fundus wall portion 14 in a position between the diaphragm 30 and at least a portion of the lower part of the invaginated stomach fundus wall 12.
  • a number of stomach-to-stomach sutures or staples may be applied from the inside of the stomach 10 to keep the invagination intact and to allow growth of tissue to keep the invagination over time. Additional affixations may be provided between the outside of the fundus wall portion 14 and the esophagus 20 and/or the diaphragm muscle 30 to hold the movement restriction device 110 in the desired position.
  • the movement restriction device 110 disclosed in figures 1-4 may have several different configurations and may not necessarily be limited to the schematic versions outlined therein. Other configurations and designs are conceivable within the inventive concept, as defined by the appended claims.
  • An example of such a variant is illustrated in figure 5, showing a movement restriction device 110 similar to the ones in figures 1-4 but formed of a plurality of segments 111 that are configured to be attached to be assembled into a complete movement restriction device 110.
  • the segments 111 may for example be secured to each other by means of mutually engaging structures such as protruding slits and receiving recesses/grooves 114, snap-fit connectors, or the like.
  • the movement restriction device 110 may be formed of five segments 111: four outer parts and an inner, core part around which the outer parts may be arranged to form a rounded and substantially smooth body suitable for invagination.
  • the segments 111 may be configured to be securely attached to each other, or to be loosely fitted and kept in their right position when invaginated by the surrounding fundus wall 12.
  • the segments 111 may be secured to each other by means of a wire.
  • the wire may be biodegradable and eventually dissolved.
  • the segments 111 may be configured to be introduced in the body of the patient separately, one by one, and assembled into the movement restriction device 110 in connection with being implanted.
  • a plurality of electrode elements 152 may be arranged on an outer surface of the segments 111, i.e., the surface of the outer parts that is to be arranged to rest against the fundus wall portion 14 when the assembled movement restriction device 110 is implanted.
  • the segments 111 may be electrically connected to each other to allow for an electrical stimulation signal to be transmitted to the electrode elements 152 on the outer surface of the movement restriction device 110.
  • the movement restriction device 110 may have a volume that is adjustable or non-adjustable after implantation.
  • the movement restriction device 110 may be formed of a body (or several segments) being solid, i.e., which is not hollow and/or comprises substantially the same material throughout. This may allow for the shape to be varied, for example during insertion into the body, such as through a tubular instrument, while the volume may be substantially the same.
  • the movement restriction device 110 is adjustable in terms of volume
  • the device may be formed of a body (or several segments) comprising one or several cavities or voids capable of accumulating an releasing a fluid for causing a corresponding expansion and reduction of the movement restriction device 110.
  • the fluid may for example be a gas or a liquid, such as a gel, which may be introduced and extracted from the movement restriction device 110 prior to implantation, during the implantation procedure, or after it has been implanted.
  • FIGS 6a and 6b illustrate an example of a movement restriction device 110, similar to the ones discussed with reference to figures 1-5, comprising a fluid communication port 115, or injection port, that can be used to add or remove a fluid to/from the inside of the movement restriction device 110 to thereby vary its volume. It may be desired to adjust the volume of the movement restriction device 110 post-operatively in order to fine tune or adjust the movement restriction device’s 110 capability of acting as a mechanical stop against the diaphragm. It may for example be determined after the implantation, in a subsequent evaluation of the results of the operation, that an implant of another size would have been more optimal for the specific patient. This may be solved by adjusting the volume of the implant posit- operatively.
  • the port 115 may be positioned such that it is accessible from outside the invagination, i.e., such that the port 115 can be accessed by an instrument or connection without having to penetrate the fundus wall portion 14.
  • the port protrudes to the outside of the invagination, passing between sutures or staples used for at least partly closing the pouch in which the movement restriction device 110 is arranged.
  • the port 115 may thus be available for connection to a tube or a syringe from the abdominal region of the patient.
  • the port 115 is positioned inside the invagination and accessed by a tube 116 that is connected to the port 115 and extends into the abdominal region of the patient.
  • the volume of the movement restriction device 110 may according to some examples be adjustable non-invasively after implantation.
  • a non-invasive adjustment may be allowed by means of the tube 116, that may be connected to the port 115 and led to the outside of the patient’s body or to an implanted volume regulator, such as a pump or a reservoir, for non-invasive regulation of the volume of the movement restriction device 110.
  • the volume of the movement restriction device 110 may be adjustable invasive ly, e.g. by means of an instrument that is inserted into the patient’s body and connected directly to the port 115 or the tube 116 for adding or removing fluid from the movement restriction device 110.
  • an instrument such as a syringe may be inserted directly into the inside of the movement restriction device 110, penetrating and passing through the surrounding fundus wall portion 14 on the way to the movement restriction device 110.
  • the adjustable and non-adjustable characteristics of the volume of the movement restriction device 110 generally refer to a permanent state of the movement restriction device 110.
  • an adjustment of the volume may, in the above context, result in a new volume that is substantially constant over time until the amount of fluid in the movement restriction device 110 is varied again.
  • temporary changes of the volume which for example may be caused by a temporary or resilient compression of the material forming the movement restriction device 110.
  • Such a temporary change in volume may for example occur during introduction of the movement restriction device 110 into the body, e.g. via a tubular instrument.
  • the movement restriction device 110 according to the examples outlined above with reference figures 1-6 may be flexible or elastic, allowing the device 110 to at least temporarily assume different shapes and, in some examples, volumes, in response to being exposed to external mechanical forces.
  • FIG. 7-13 schematically illustrate an apparatus 100 comprising an at least partly ringshaped implantable movement restriction device comprising a first portion 110 configured to be at least partly invaginated by a first wall portion of the patient’s stomach 10 and arranged such that at least a part of the first portion of the apparatus 100 is arranged above the cardia 22 of the patient’s stomach 10, and such that movement of the cardia towards the diaphragm is restricted to prevent the cardia 22 from sliding through the diaphragm opening 32 into the patient’s thorax.
  • the configuration and function of the first portion 110 of the apparatus 100 may hence be similar to the movement restriction devices 110 previously described with reference to figures 1-6.
  • the apparatus 100 may comprise an electrode arrangement 150 which may be similar to the electrode arrangement 150 described in connection with the examples of figures 1-6, and may hence be configured to be arranged between the first portion 110 of the apparatus 100 and the first wall portion 14 to electrically stimulate muscle tissue of the first wall portion 14 to exercise the muscle tissue and thereby improve the conditions for long term implantation of the apparatus 100.
  • an electrode arrangement 150 which may be similar to the electrode arrangement 150 described in connection with the examples of figures 1-6, and may hence be configured to be arranged between the first portion 110 of the apparatus 100 and the first wall portion 14 to electrically stimulate muscle tissue of the first wall portion 14 to exercise the muscle tissue and thereby improve the conditions for long term implantation of the apparatus 100.
  • the apparatus 100 may further comprise a second portion 120, which may be configured to be arranged on an opposite side of the cardia 22, as seen from the first portion 110.
  • the first portion 110 and the second portion 120 may together form the at least partly ring-shaped movement restriction device 110, 120, which as indicated in the present figures may be configured to be arranged to at least partly encircle the esophagus 20 of the patient.
  • the first portion 110 may for example be configured to be arranged on the fundus side of the esophagus 20, whereas the second portion 120 may be configured to be arranged on the side of the esophagus 20, i.e., the side opposing the fundus 12.
  • the movement restriction device 110 may in some examples be formed of a substantially smooth, ring-shaped body configured to encircle the esophagus 20.
  • the movement restriction device 110 may for example have a shape conforming to a torus, with the first portion 110 forming the part arranged at the fundus side of the esophagus and the second portion 120 forming the part arranged at the opposite side of the esophagus 20.
  • the ring-shaped body of the movement restriction device 110 may comprise an opening, or be possible to open, so as to allow the body to be arranged around the esophagus.
  • the movement restriction device 110 may be affixed in a desired position, preferably at least partly above the cardia 22, by for example invaginating at least one of the first portion 110 and the second portion 120 by the outer wall of the stomach 10, or by wrapping a part of the stomach wall around at least a part of the ring-shaped body.
  • the movement restriction device 110 is implanted such that a part of the stomach wall is arranged between the movement restriction device 110 and the outside of the esophagus 20 to as to protect the tissue of the esophagus from being damaged by the movement restriction device 110, 120 abutting the tissue of the esophagus 20.
  • a part of the fundus 12 may be arranged between the first portion 110 and the esophagus 20 and at the same time provide an affixation of the device to the stomach 10.
  • the movement restriction device may be provided with a shape and size allowing for a gap to be defined and maintained between the second portion 120 and the side of the esophagus opposite to the fundus side. Due to the affixation of the first portion 110 to the fundus 12, the separating gap between the second portion 120 and the tissue of the esophagus 20 may be maintained after implantation.
  • Figure 10 shows an alternative example, in which the second portion 120 of the movement restriction device 110, 120 is arranged with a part of the stomach wall between the second portion 120 and the esophagus 20, on the side of the esophagus 20 opposing the fundus 12.
  • the first portion 110 may be arranged to define a distance or gap to the esophagus 20, similar to what is described figures 7-9.
  • Figure 11 shows a further example, wherein the first portion 110 may be placed at the angle of His and the second portion 120 invaginated by a pouch protruding into the stomach wall on the opposite side of the esophagus 20.
  • the pouch may be arranged further down, compared to the example in figure 10.
  • the first portion 110 and the second portion 120 may in figure 10 be implanted at substantially the same height relative to the cardia, whereas in figure 11 only the first portion 110 is implanted at least partly above the cardia 12.
  • Figures 12 and 13 show various examples of at least partly ring-shaped movement restriction devices 110, 120, wherein the first portion 110 and the second portion 120 may be integrally formed into a single piece as shown in figure 12, or be formed of a plurality of core elements 213 arranged in a cover 220 as shown in figure 13.
  • the movement restriction devices 110, 120 may for example conform to a torus, which may be closed or at least partly closed when implanted. Similar to the apparatuses illustrated in figure 7-11, the apparatus may be implanted in a position wherein it at least partly encircles the esophagus 20 and may function as a movement restriction device.
  • the apparatuses may further comprise an electrode arrangement 150.
  • the electrode arrangement 150 of the examples shown in figures 7-13 may comprise one or several electrode elements 152, 154, which may be arranged between at least one of the first portion 110 and the second portion 120 and the tissue against which the respective portion 110, 120 rests and operate according to principles similar to the ones discussed with reference to figures 1-6.
  • the electrode arrangement 150 may be configured to electrically stimulate and exercise muscle tissue of the fundus wall 12 or the esophagus 20 to improve conditions for long term implantation, and in some examples to electrically stimulate the cardiac sphincter muscle 26 so as to cause the sphincter to contract.
  • the second portion 120 may be configured to act as an elongated support device for the electrode elements 154 for the cardiac sphincter stimulation, similar to the examples disclosed in connection with the previous figures.
  • the apparatus 100 may be configured to be at least partly invaginated, or covered, by the stomach wall along at least half of the toroidal length (i.e., the length as seen in the direction of the circumference encircling the esophagus).
  • An example is illustrated in figure 8, wherein a toroidally shaped apparatus is at least partly covered by the fundus 12 along at least half the toroidal length.
  • a similar arrangement is illustrated in figures 7, 9, 10 and 11, wherein at least 25%, such as for example 50%, of the circumferential length of the apparatus may be at least partly invaginated or covered by stomach wall tissue.
  • the apparatus 100 may be substantially ring-shaped and may comprises two end portions configured to be coupled to each other to form a closed ring.
  • the end portions are configured to be releasably attached to each other, for example by means of a locking mechanism 216 or a fastener 216.
  • the size of the apparatus may be characterized by its poloidal circumference and its toroidal circumference.
  • the poloidal direction may be understood as a direction following a small circular ring around the surface, while the toroidal direction follows a large circular ring around the torus or ring, encircling the central void in which the esophagus may be arranged.
  • the poloidal circumference of the apparatus may be larger for the first portion 110 than for the second portion 120, as shown in figures 12 and 13.
  • the first portion 110, forming the movement restriction device 110 may have a larger poloidal circumference so as to provide a mechanical stop hindering movement of the cardia towards and/or through the opening in the diaphragm.
  • the first portion 110 may have a minimal width or cross section, as measured orthogonal to the toroidal direction, being 30 mm or larger, such as 40 mm or larger.
  • a minimum poloidal circumference of the first portion 110 of the movement restriction device may be 150 mm or less, such as 130 mm or less, such as 110 mm or less, such as 90 mm or less, such as 70 mm or less, such as 50 mm or less, such as 30 mm or less.
  • a maximum width of a cross section taken across a length direction (i.e. across toroidal direction) of the first portion 110, or movement restriction device 110 may be larger than a maximum width of a cross section taken across a length direction of the second portion 120, or support device 120.
  • the apparatus 100 may be affixed to the stomach wall in several different ways, all of which may include to at least partly wrap the stomach wall 10 around at least a portion of the apparatus 100 and affixing the stomach wall 10 to itself and/or to the esophagus 20.
  • Some non-limiting examples of placing and affixing the apparatus 100 at the stomach wall 10 will now be discussed with reference to the ringshaped movement restriction device 110, 120 disclosed in figures 7-13.
  • the movement restriction device has been placed around the esophagus 20, such that the first portion 110 is arranged at the fundus side and the second portion 120 at the opposing side of the esophagus.
  • a part of the fundus wall 12 has then been wrapped around the first portion 110 of the movement restriction device, from the outside of the device and into the center hole of the ring-shaped body, such that the part of the fundus wall 12 is arranged between the inner periphery of the ring-shaped body and the esophagus 20.
  • the part of the fundus wall 12 that is wrapped around the first portion 110 may be considered as a “flap” formed of the fundus wall, which may be formed outside the ring-shape and pushed into the hole defined by the ring-shape and affixed to the esophagus 20.
  • Figure 8 shows a perspective view of an apparatus 100 which may be similar to the one in figure 7, illustrating the affixation of the first portion 110 of the movement restriction device 110, 120 to the fundus 12.
  • the part of the fundus that is wrapped around the first portion 110 and affixed to the esophagus may form a tunnel through which the ring-shaped body may extend on its way around the esophagus.
  • Figure 9 shows an another example, in which the fundus portion closest to the angle of His has been folded to rest against the esophagus, from the angle of His and upwards along the esophagus, and affixed to the esophagus with one or several lines of fasteners, such as staples or sutures, extending along the esophagus.
  • the first portion 110 of the movement restriction device may then be invaginated by another portion of the fundus, arranged further away from the angle of His, such that the movement restriction device is kept in place by the affixation to the esophagus and encircling the esophagus such that the second portion 120 is arranged on the opposite side of the esophagus 20.
  • the method according to figures 7 and 8 may result in the first portion 110 being arranged between the esophagus 20 and the portion of the fundus that is affixed to the esophagus 20, whereas the method according to figure 9 may result in the portion of the fundus 12 that is affixed to the esophagus 20 being arranged between the esophagus 20 and the first portion 110 of the movement restriction device.
  • a part of the fundus may be pushed into the hole of the ringshaped body from below, whereas in the latter example a part of the fundus may be pushed into the hole from above.

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Abstract

L'invention concerne un dispositif médical implantable pour le traitement d'un trouble de reflux. Le dispositif médical implantable comprend un dispositif de restriction de mouvement configuré pour être fixé à la paroi de l'estomac afin d'empêcher le mouvement du sphincter œsophagien inférieur par rapport au diaphragme thoracique. Le dispositif de restriction de mouvement comprend : une première partie (111a), une seconde partie (111b) et un premier élément séparateur (151). Les première et seconde parties sont configurées pour être reliées l'une à l'autre pour former au moins une partie d'un dispositif de restriction de mouvement fonctionnel. La première et la seconde partie peuvent se désolidariser l'une de l'autre, de sorte qu'elles peuvent passer individuellement dans le tractus gastro-intestinal, et le premier élément séparateur est configuré pour créer un espace situé entre la première et la seconde partie, l'espace étant configuré pour permettre la croissance du tissu fibreux entre les parties de la première et de la seconde partie.
PCT/EP2023/087772 2022-12-23 2023-12-22 Traitement du reflux gastro-œsophagien pathologique WO2024133956A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2024/050047 WO2024133974A1 (fr) 2022-12-23 2024-01-02 Traitement d'une maladie de reflux gastro-oesophagien

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE2251565 2022-12-23
SE2251565-4 2022-12-23

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WO2024133956A1 true WO2024133956A1 (fr) 2024-06-27

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PCT/EP2023/087772 WO2024133956A1 (fr) 2022-12-23 2023-12-22 Traitement du reflux gastro-œsophagien pathologique
PCT/EP2023/087773 WO2024133957A1 (fr) 2022-12-23 2023-12-22 Traitement d'un reflux gastro-œsophagien pathologique

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PCT/EP2023/087773 WO2024133957A1 (fr) 2022-12-23 2023-12-22 Traitement d'un reflux gastro-œsophagien pathologique

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WO2024133957A1 (fr) 2024-06-27

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