WO2024170786A1 - Système d'administration de médicament - Google Patents

Système d'administration de médicament Download PDF

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Publication number
WO2024170786A1
WO2024170786A1 PCT/EP2024/054086 EP2024054086W WO2024170786A1 WO 2024170786 A1 WO2024170786 A1 WO 2024170786A1 EP 2024054086 W EP2024054086 W EP 2024054086W WO 2024170786 A1 WO2024170786 A1 WO 2024170786A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
infusion needle
arm
stylet
housing
Prior art date
Application number
PCT/EP2024/054086
Other languages
English (en)
Inventor
Peter Forsell
Original Assignee
Medicaltree Patents Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/EP2023/053894 external-priority patent/WO2023156523A1/fr
Application filed by Medicaltree Patents Ltd. filed Critical Medicaltree Patents Ltd.
Publication of WO2024170786A1 publication Critical patent/WO2024170786A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0267—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body comprising sensors or electrical contacts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • A61M2205/8243—Charging means by induction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids

Definitions

  • the present invention relates generally to the infusion of a substance, in particular drugs, into a patient’s body, in particular into a patient’s blood circulation system or in order to stimulate penis erection, by means of an at least partly implantable drug delivery system.
  • the present disclosure particularly relates to systems for injecting a substance into the patient's body and also to methods of using the system and methods of implanting the system.
  • the infusion needle is movably arranged in a housing so that it can be advanced in order to penetrate with a tip end thereof a septum, such as a silicone membrane, in the housing’s outer wall. Arranging the infusion needle inside the housing prevents any fibrosis from growing into the infusion needle. However, frequent piercing of the same body part may cause irritation, eventually making further piercing difficult or even impossible.
  • a plurality of infusion needles or a single laterally displaceable infusion needle is provided so as to penetrate the housing’s outer wall at different penetration sites. This allows for variation of the injection sites and penetration of different injection sites at different times, thereby giving the human tissue time to recover from the piercing by the infusion needle.
  • a drive unit is provided for advancing and retracting as well as for laterally displacing the infusion needle or needles accordingly.
  • a part of the drive unit may be provided for implantation remote from the injection area and may comprise a pull wire guided in a sheath to cause lateral movement of the infusion needle upon pulling the remote end of the wire.
  • pulling the wire may cause the tip end of the infusion needle or needles to displace laterally from a first to a second penetration site.
  • a single pulling wire may be sufficient to cause lateral movement of the infusion needle in one direction, whereas a spring element urges the infusion needle back to a starting position, or two pulling wires may be provided to move the infusion needle laterally back and forth.
  • a further pulling wire may be arranged to advance or retract the infusion needle and, again, a spring element may be provided to urge the infusion needle back to a starting position.
  • the drive unit may comprise one or more rotating shafts, with a worm screw at the end of the shaft cooperating with a gear for advancing and/or or retracting the infusion needle and/or for laterally moving the tip end of the infusion needle.
  • the rotating shafts are flexible and guided in a sheath so as to transmit kinetic energy from a remote position towards the implantable infusion device.
  • the system may further comprise one or more electric motors inside and/or outside the housing for driving the drive unit or parts of the drive unit, such as the wire/wires or drive shaft/shafts, and may further comprise at least one reservoir adapted for implantation inside the patient’s body and being in fluid connection with the infusion needle or needles so as to supply to the infusion needle the substance to be injected.
  • a pump which is also adapted for implantation inside the patient’s body, may be provided to advance the substance from the reservoir to the infusion needle or needles.
  • the drive unit is configured to advance and retract the infusion needle or needles. In WO 2010/040548 Al, this is generally achieved by mounting the infusion needle in a slidable manner and urge it back into a rest position by means of a return spring.
  • the drive unit is configured to laterally displace the tip end of an infusion needle to different penetration sites or to actuate different ones of a plurality of infusion needles.
  • first aspect a cross-guide for lateral translation of the injection needle between different injection sites
  • second aspect a translating frame for advancing and retracting the infusion needle
  • third aspect a cable driven injection needle with a block -and-tackle setup of the cable
  • fourth aspect a cable driven injection needle with a combined advancement and displacement cable
  • fifth aspect an infusion needle with a lateral port for feeding infusion liquid to the needle
  • first new aspect a short distance between a lateral needle injection port and the tip end of the needle
  • second new aspect an inclined arrangement of the infusion needle, in particular a curved infusion needle (as a sub-aspect for which priority is claimed herein from WO 2023/156523 Al)
  • third new aspect an arrangement of the infusion needle in a tube which liquid-tightly seals an
  • a tip end of the infusion needle penetrates, upon advancement, said penetration area so as to allow for injecting the substance through the penetration area via the needle or needles.
  • penetration of the penetration area by the tip end upon advancement of the infusion needle does not necessarily mean that, prior to such advancement, the tip end resides inside the housing spaced apart from the internal side of the housing’s or casing’s outer wall. Rather, the infusion needle may even extend with its tip end into the outer wall prior to its advancement and, upon advancement, penetrate the wall so as to extend from the external side of the wall. This is at least an option in those embodiments where the infusion needle is not displaced laterally between successive injection cycles.
  • the tip end of the infusion needle or needles may extend from the penetration area when the infusion needle or needles is/are in the retracted position.
  • the penetration area may preferably be formed from a membrane which may be made of a material that can be easily penetrated by the infusion needle, in particular of an elastomeric polymer material, such as silicone, in some instances the penetration area may simply be a hole in the wall through which the needle can be advanced from inside of the housing or casing to the outside thereof, i.e. only the hole needs to be penetrated, rather than a membrane closing such hole.
  • At least one of the motor or motors of an at least partly implantable system for injecting a substance into a patient’s body is a piezoelectric motor and/or at least one of the pump or pumps of such system is a piezoelectric pump.
  • the motor or motors for driving an injection needle may involve one or more piezoelectric motors
  • the pump or pumps for delivering infusion liquid to the patient may involve one or more piezoelectric motors for driving the pump or pumps or may involve one or more piezoelectric pumps.
  • the motors and pumps of the at least partly implantable systems for injecting a substance into a patient’s body as disclosed in WO 2010/040548 Al and WO 2023/156523 Al may comprise one or more piezoelectric motors and/or one or more piezoelectric pumps.
  • Piezoelectric motors are advantageous in that they may have high precision, low power consumption, may be made small and lightweight, may provide high motion accuracy, and may be made from materials which are relatively immune to interference, such as electromagnetic interference.
  • piezoelectric motors can be manufactured without magnetic and/or metallic parts.
  • piezoelectric motors can be made MRI-safe, meaning that the patient can undergo Magnetic Resonance Imaging (MRI) while having the piezo motor implanted.
  • MRI Magnetic Resonance Imaging
  • the piezoelectric motor is a piezoelectric inchworm motor.
  • the piezoelectric motor is a piezoelectric inertial motor.
  • the piezoelectric motor is a piezoelectric walk -drive motor.
  • the piezoelectric motor is a piezoelectric ultrasonic motor.
  • the piezoelectric motor may be a linear piezoelectric motor, which may operate with at least one of: a speed in the range of 1 mm/s - 10 mm/s, a stroke length in the range of 4 mm - 30 mm, and a force in the range of 2 N - 30 N, or the piezoelectric motor may be a rotary piezoelectric motor, which may operate with at least one of: a rotational speed in the range of 1 mrad/s - 100 mrad/s and a torque in the range of 100 Nmm - 900 Nmm.
  • the piezoelectric ultrasonic motor may be a linear piezoelectric ultrasonic motor, which may operate with at least one of: a speed in the range of 4 mm/s - 100 mm/s, a stroke length in the range of 4 mm - 30 mm, and a force in the range of 0.006 N - 40 N, or it may be a rotary piezoelectric ultrasonic motor which may operate with at least one of: a rotational speed in the range of 10 mrad/s - 10,000 mrad/s, and a torque in the range of 20 Nmm - 450 Nmm.
  • piezoelectric motors have a relatively complex structure and control system, they may feature a linear resolution as low as 0.21 pm.
  • the piezoelectric motor comprises at least one bimorph piezoelectric actuator.
  • the piezoelectric motor according to any one of the variants is preferably substantially nonmagnetic and/or non-metallic.
  • the piezoelectric motor may be a reversible piezoelectric motor.
  • the piezoelectric motor may form part of a drive unit for driving the at least one infusion needle.
  • the piezoelectric motor may be configured to drive a pump for injecting a substance into the patient’s body via the at least one infusion needle
  • a piezoelectric pump comprising a first wall portion, a first diaphragm, a first chamber and a driving element.
  • the first diaphragm and the first wall portion enclose the first chamber.
  • the first wall portion comprises an inlet configured to connect the first chamber to a first inlet reservoir and an outlet configured to connect the first chamber to a first outlet reservoir.
  • the first diaphragm is configured to bend in response to operation of the driving element, and the driving element comprises a piezoelectric actuator, or is configured to be operated by a piezoelectric motor.
  • Piezoelectric pumps are advantageous in that they are miniaturized and energyefficient implantable devices. Piezoelectric pumps may precisely deliver fluid with a flow rate in the range of 0.01 ml/min to 35 ml/min and a pressure in the range of 0.2 kPa to 36 kPa.
  • a piezoelectric pump wherein the inlet of the first wall portion comprises an inlet valve and the outlet of the first wall portion comprises an outlet valve.
  • Any of the inlet valve of the first wall portion and outlet valve of the first wall portion may be a check valve or an active valve.
  • the check valve may be a ball valve. The inlet valve and outlet valve are useful to stabilize the flow rate in the first chamber.
  • the inlet of the first wall portion comprises an inlet static element and the outlet of the first wall portion comprises an outlet static element, wherein any of the inlet static element and outlet static element is configured to act as a nozzle or a diffuser.
  • Nozzles and diffusers are advantageous in that they are more resistant to wear and fatigue failure as compared to check valves and active valves.
  • the first diaphragm comprises a first movable wall portion.
  • the first movable wall portion may comprise elevated and lowered portions, wherein the elevated and lowered portions enable at least one of compression and expansion for moving the first movable wall portion.
  • the first movable wall portion may comprise a substantially stiff portion.
  • the first movable wall portion may comprise a bellows.
  • the bellows may comprise metal.
  • the bellows may comprise at least one of an oval cross section, an elliptic cross-section and a circular cross-section.
  • Metals are generally dense, which is advantageous as fluids do not diffuse through metals as easily. This reduces the risk that fluid diffuses from the first chamber or that fluids diffuse into the first chamber.
  • a piezoelectric pump which further comprises an auxiliary wall portion and an auxiliary chamber sealed from the first chamber.
  • the auxiliary wall portion and the first diaphragm enclose the auxiliary chamber.
  • the sealing of the auxiliary chamber from first chamber is advantageous in that a component unsuitable to be in contact with the fluid in the first chamber may be hosted by the auxiliary chamber. Such a component may be the driving element.
  • a piezoelectric pump which further comprises an auxiliary wall portion, an auxiliary chamber sealed from the first chamber, and an auxiliary diaphragm configured to bend in the same direction as the first diaphragm in response to operation of the driving element.
  • the auxiliary wall portion and the auxiliary diaphragm enclose the auxiliary chamber.
  • the auxiliary chamber is configured to be connected to a pressure adapter enabling variation of pressure in the auxiliary chamber.
  • the pressure adapter may comprise an elastic portion having a surface area, and the elastic portion may be configured to maintain substantially the same surface area while enabling variation of pressure in the auxiliary chamber. This is advantageous in that a fibrotic tissue which at least partially covers the elastic portion may easily adapt to the elastic portion.
  • a piezoelectric pump which further comprises a second wall portion, a second diaphragm and a second chamber.
  • the second diaphragm and the second wall portion enclose the second chamber.
  • the second wall portion comprises an inlet, configured to connect the second chamber to a second inlet reservoir, and an outlet, configured to connect the second chamber to a second outlet reservoir.
  • the second diaphragm is configured to bend in the same direction as the first diaphragm in response to operation of the driving element.
  • the embodiment is advantageous in that the piezoelectric pump is configured to be operated in a double mode.
  • the inlet of the second wall portion comprises an inlet valve and the outlet of the second wall portion comprises an outlet valve.
  • Any of the inlet valve of the second wall portion and outlet valve of the second wall portion may be a check valve or an active valve.
  • the check valve may be a ball valve. The inlet valve and outlet valve are useful to stabilize the flow rate in the second chamber.
  • the inlet of the second wall portion comprises an inlet static element and the outlet of the second wall portion comprises an outlet static element, wherein any of the inlet static element and outlet static element is configured to act as a nozzle or a diffuser.
  • Nozzles and diffusers are advantageous in that they are more resistant to wear and fatigue failure as compared to check valves and active valves.
  • the piezoelectric pump comprises at least two portions connected in series, wherein each portion is a piezoelectric pump.
  • the series connection allows for larger pressure compared to piezoelectric pumps in which fluid is transferred from an inlet to an outlet reservoir via a single chamber.
  • the piezoelectric pump comprises at least two portions connected in series, wherein each portion is a piezoelectric pump configured to be operated in a double mode.
  • the series connection allows for larger pressure as compared to piezoelectric pumps configured to be operated in a double mode in which a first fluid is transferred from a first inlet reservoir to a first outlet reservoir via a single first chamber and a second fluid is transferred from a second inlet reservoir to a second outlet reservoir via a single second chamber.
  • the piezoelectric pump comprises at least two portions connected in parallel, wherein each portion is a piezoelectric pump.
  • the parallel connection allows for a higher flow rate as compared to piezoelectric pumps in which the inlet reservoir is configured to be connected to a single inlet and the outlet reservoir is configured to be connected to a single outlet.
  • the piezoelectric pump comprises at least two portions connected in parallel, wherein each portion is a piezoelectric pump configured to be operated in a double mode.
  • the parallel connection allows for a higher flow rate as compared to piezoelectric pumps configured to be operated in a double mode in which the first inlet reservoir and second inlet reservoir are configured to be connected to a single first inlet and single second inlet, respectively, and the first outlet reservoir and second outlet reservoir are configured to be connected to a single first outlet and single second outlet, respectively.
  • the drug delivery system further comprises a controller configured to control the piezoelectric pump.
  • the drug delivery system further comprises a sensor configured to measure a parameter of the piezoelectric pump, and a feedback unit.
  • the sensor is further configured to transmit the measured parameter to the feedback unit.
  • the feedback unit is configured to transmit a conditioning signal to the controller based on the measured parameter received from the sensor and based on a set value of the parameter.
  • the controller is configured to adjust the control of the piezoelectric pump based on the conditioning signal received from the feedback unit in order for the measured parameter to achieve the set value.
  • the piezoelectric pump may be provided for injecting the substance into the patient’s body via the at least one infusion needle when the infusion needle is in the advanced position.
  • the system may further comprise a needle cooperating member arranged to cooperate with the at least one infusion needle upon the advancing or retracting of the at least one infusion needle and a cross guide to which the needle cooperating member is coupled so as to be movable into different positions in a displacement direction which is different to the advancing and retracting directions.
  • advancing or retracting the infusion needle may involve prior lateral displacement of the needle cooperating member along the cross guide to different injection site positions.
  • the cross guide is fixedly held between two opposing fixing points in order to provide a structure which is sufficiently stiff to ensure proper alignment of the needle cooperating member relative to the injection sites independent of the needle cooperating member’s position on, or relative to, the cross guide.
  • the cross guide may comprise a shaft on which the needle cooperating member is slidably mounted.
  • the cross guide preferably extends in a displacement direction that is perpendicular to the advancing and retracting directions of the needle or needles, but may alternatively extend in a direction that is inclined relative to the advancing and retracting directions of the needle or needles if the space where the housing is to be implanted in the patient’s body so requires.
  • the system comprises a translating frame arranged to move in the advancing and retracting directions of the needle or needles, wherein the cross guide is fixed to the translating frame so as to move together with the translating frame.
  • the needle cooperating member may be moved in the advancing and retracting directions of the needle or needles so as to advance or retract the needle or needles.
  • the arrangement is such that a single needle is advanced or retracted upon movement of the translating frame.
  • the needle cooperating member is preferably arranged to cooperate with a respective one infusion needle of the array of infusion needles at a time.
  • the needle cooperating member may be arranged for acting on the array of infusion needles so as to advance or retract, depending on its position relative to the cross guide, the respective one infusion needle.
  • the needle cooperating member may be separate from the array of infusion needles. That is, in a rest position, the needle cooperating member may be disengaged from the infusion needles and, upon movement of the translating frame, it may engage the respective one of the infusion needles.
  • the infusion needles of the array of infusion needles may be mounted in a mounting block so as to be slidable in the advancing and retracting directions, wherein the needle cooperating member is preferably arranged to advance the respective one infusion needle by pushing it in the advancing direction.
  • the needle cooperating member may comprise a needle driver part and a positioning part, wherein the needle driver part and the positioning part are arranged to disengage from each other when the translating frame moves in the advancing direction.
  • a secondary cross guide member may be arranged in parallel to the cross guide, wherein the positioning part is movably, preferably slidably, mounted on the main secondary cross guide member and the needle driver part is movably, preferably slidably, mounted on the (main) cross guide.
  • the arrangement is such that, when the positioning part and the needle driver part are engaged, the positioning part may be moved along the secondary cross guide member in the displacement direction, thereby moving the needle driver part along the main cross guide also in the displacement direction into a desired position, and, when the needle driver part has been positioned, the aforementioned translating frame may be moved in the advancing or retracting direction so that the needle driver part and the positioning part disengage from each other and so that the needle driver part may cooperate with the respective one infusion needle of the array of infusion needles.
  • a displacement cable which will be described in further detail hereinafter, may be provided for pulling the needle cooperating member along the cross guide in the displacement direction and may be connected to the positioning part of the needle cooperating member.
  • the single infusion needle may be attached to the needle cooperating member so as to be movable in the displacement direction together with the needle cooperating member.
  • the single infusion needle may be welded or potted to the needle cooperating member so as to securely hold the infusion needle in place.
  • the single infusion needle may have a curved section by which it is attached to the needle cooperating member. This may facilitate mounting of the infusion needle at a correct position of the needle cooperating member when the system is being assembled. More specifically, the curved section may be fixedly held in a correspondingly curved recess of the needle cooperating member. The curved recess provides a counter-force to forces acting on the needle when the needle is advanced to pierce with its front end through the penetration area in the wall of the housing.
  • a needle-reinforcing tube may be placed around the single infusion needle to help minimize any deflection of the infusion needle when penetrating the penetration area of the housing’s wall.
  • a tubing for supplying the substance to be injected through the single infusion needle may be connected to an end of the single infusion needle and looped inside the housing to allow the tubing a required range of motion.
  • At least one motor may be provided, in particular a piezoelectric motor, such as a first motor for advancing and/or retracting the needle or needles in opposite advancing and retracting directions and a second motor for displacing the needle or needles or the needle cooperating member in a different lateral displacement direction.
  • a piezoelectric motor such as a first motor for advancing and/or retracting the needle or needles in opposite advancing and retracting directions and a second motor for displacing the needle or needles or the needle cooperating member in a different lateral displacement direction.
  • two motors may be provided for, in cooperation, advancing and/or retracting the needle or needles in the opposite advancing and retracting directions and for displacing the needle or needles or the needle cooperating member in the different lateral displacement direction.
  • the motor or motors may be arranged within the housing in which the needle or needles are arranged. However, depending on the space that is available for implanting the housing within the patient’s body, it may be desirable to keep the housing small. In that case, one or more pull cables may be provided to extend from one or more motors, which are remotely arranged inside or even outside the patient’s body, into the housing in order to transfer kinetic energy into the housing for moving the needles or needles that are arranged in the housing. Also, one or more cables or belts may be provided inside the housing to transmit energy between components that are arranged inside the housing.
  • a motor or cable is arranged to advance the infusion needle or needles in the advancing direction and, e.g., resilient means, such as a spring element, are provided for urging the needle or needles back into a rest position
  • the arrangement may likewise be opposite such that the motor or cable is arranged to retract the infusion needle or needles into the rest position and, e.g., resilient means, such as a spring element, are provided for advancing the needle or needles into an operating position.
  • the cable is preferably a Bowden cable so that it can transmit pulling forces while being bendable. This is particularly advantageous in situations where a part of the drive unit is remote from the housing and where the cable extends into the housing from a remotely arranged motor, in particular from a piezoelectric motor.
  • a cable is typically understood as comprising a coated set of wires
  • a cable in the sense of the present disclosure may comprise one or more wires, uncoated or preferably coated, such as a single uncoated wire, a single coated wire, a set of uncoated wires, a set of coated wires, or a coated set of wires.
  • the wires are preferably made of metal, but may alternatively be made or comprise one or more polymer wires.
  • the system may comprise a displacement cable or a displacement belt for pulling the needle cooperating member along the cross guide in the displacement direction.
  • a tensioning spring may be arranged to provide a counter-force counteracting the pulling force of the displacement cable that may be acting on the needle cooperating member.
  • the tensioning spring thus helps to hold the needle positioning member in position relative to the cross guide.
  • the counter-force provided by the tensioning spring is strong enough to move the needle cooperating member in a direction opposite the displacement direction when there is no pulling force of the displacement cable acting on the needle cooperating member.
  • the pulling force of the displacement cable may be released so that the counter-force of the tensioning spring causes the needle cooperating member to return to a starting position.
  • the tensioning spring is designed as a constant-force tensioning spring.
  • the pulling force required to move the needle cooperating member along the cross guide, and thus the power provided by an associated motor, in particular by a piezoelectric motor is constant independent of the position of the needle cooperating member relative to the cross guide.
  • the tensioning spring may comprise a metal band which winds on itself when it is not tensioned. One end of the metal band may be attached to a reel and the other end may be connected to the needle cooperating member. Then, when the needle cooperating member is pulled step by step along the cross guide with the aid of the displacement cable, the tensioning spring creates a constant counter-force.
  • the tensioning spring When the pulling force of the displacement cable is released, the tensioning spring winds automatically back onto the reel, thereby pulling the needle cooperating member back into its starting position.
  • the tensioning spring provides a tensioning force of between 0.5 N and 2 N, preferably between 0.8 N and 1.2 N, most preferably about 1 N.
  • the displacement cable or displacement belt may be arranged for pulling the needle cooperating member along the cross guide in opposite first and second displacement directions.
  • a tensioning spring as described above is not required in this case because the needle cooperating member may be returned to its starting position by means of the displacement cable.
  • a first wheel and a second wheel may be provided, the first wheel having a first axis of rotation and the second wheel having a second axis of rotation in parallel to and spaced apart from the first axis, wherein the displacement cable or displacement belt winds around the first and second wheels.
  • the displacement cable or displacement belt is endless.
  • it may be provided in the form of a loop extending from the first wheel to the second wheel, winding around the second wheel by 180° or preferably - in order to prevent sliding of the cable or belt - by 180° and a number of additional complete revolutions, extending back from the second wheel to the first wheel, and winding around the first wheel by 180° or - again - preferably by 180° and a number of additional complete revolutions.
  • the needle cooperating member moves in the first and second displacement direction depending on the direction of rotation of the first and second wheels.
  • a tensioning element may be provided to create a tensioning force on the displacement cable or displacement belt in a direction transverse to a longitudinal axis of the displacement cable or displacement belt so as to reduce any slack in the displacement cable or displacement belt.
  • a motor in particular a piezoelectric motor, may be arranged inside or even outside the housing to provide power for rotating the first or second wheel.
  • a drive cable to rotate the first or second wheel, the drive cable accordingly extending out of the housing to a remote motor.
  • the drive cable may connect to one of the first and second wheels and wind on and off the first or second wheel or around the first or second wheel.
  • At least one of the first and second wheels may be mounted on a drive shaft so as to rotate by rotation of the drive shaft and the drive cable may connect to the drive shaft in order to drive the drive shaft.
  • a third wheel may be mounted on the drive shaft and the drive cable may wind on and off the third wheel or around the third wheel.
  • the drive cable may be attached to the respective wheel with one end of the drive cable so that the drive cable unwinds and a section of the drive cable moves out of the housing when the cable is being pulled in a first direction, wherein a tensioning spring is arranged so as to pull the drive cable into an opposite second direction back into the housing onto the respective wheel.
  • the drive cable may be arranged so that, when the drive cable is being pulled, one section of the drive cable moves into the housing while another section of the drive cable moves out of the housing.
  • a first alignment structure may be arranged on the needle cooperating member and a second alignment structure may be arranged stationary so that the first and second alignment structures engage with each other and define different rest positions for the needle cooperating member when the needle cooperating member is moved along the cross guide into different positions. This arrangement supports exact positioning of the needle cooperating member.
  • the first alignment structure may be a leaf spring and the second alignment structure may comprise a plurality of stationary detents or protrusions arranged to cooperate with the leaf spring or, alternatively, the first alignment structure may comprise the plurality of detents or protrusions and the second alignment structure comprises one or more stationary leaf springs arranged to cooperate with the detents or protrusions.
  • the leaf spring is urged backwards to disengage from the detents or protrusions and then snaps forward again in order to reengage with one or more neighboring detents or protrusions.
  • the system comprises at least one linear bearing, preferably two parallel linear bearings, and a translating frame arranged to move along the linear bearing or bearings in the advancing and retracting directions of the at least one infusion needle so as to advance or retract or both advance and retract the infusion needle or needles by respective movement of the translating frame.
  • the cross guide described above to which the needle cooperating member is coupled may be fixed to the translating frame so that it can be moved together with the translating frame in the needle advancing and retracting directions.
  • the two linear bearings preferably take the form of two parallel shafts to which the translating frame is slidably mounted.
  • At least one return spring may be arranged to urge the translating frame into a rest position.
  • the at least one return spring may comprise a coil spring arranged around one linear bearing or, more preferably, two coil springs arranged around respective ones of two parallel linear bearings.
  • the drive unit may comprise an advancement cable which is arranged so that pulling the advancement cable causes the advancing or retracting of the at least one infusion needle.
  • the advancement cable may be arranged to move the translating frame along the at least one linear bearing in the advancing and retracting directions, thereby advancing and/or retracting the infusion needle or needles.
  • the advancement cable may be guided through the wall of the housing towards a motor, in particular to a piezoelectric motor, which is arranged remote from the housing at a location outside the patient or more preferably at a location somewhere inside the patient.
  • the advancement cable may form part of a block-and-tackle setup. This reduces the amount of power that is needed to advance the needle or needles through the penetration area in the wall of the housing. Accordingly, the motor for driving the advancement cable may be relatively small, in particular a piezoelectric motor.
  • the block-and-tackle setup may comprise at least one first pulley, preferably two first pulleys, fixed to the translating frame so as to move together with the translating frame and at least one second pulley, preferably two second pulleys, fixed to the housing so as to be stationary.
  • one end of the advancement cable is either fixed to the housing or to the translating frame.
  • the advancement cable when the advancement cable is fixed with one of its ends to the housing and the advancement cable is being pulled so as to move the translating frame, it winds along the first pulley which moves along with the translating frame, thereby dividing the pulling force necessary for moving the translating frame by 2.
  • the pulling force may be further divided in half once again.
  • the drive unit may comprise a combined advancement and displacement cable which is arranged so that pulling the advancement and displacement cable allows for causing both the advancing or retracting of the at least one infusion needle and the displacement of the at least one infusion needle in a displacement direction which is different to the advancing and retracting directions.
  • a first actuator may be attached to a first end of the advancement and displacement cable and a second actuator may be attached to a second end of the advancement and displacement cable, wherein the first actuator is arranged so as to allow pulling and moving the advancement and displacement cable in a first pulling direction and the second actuator is arranged so as to allow pulling and moving the advancement and displacement cable in a second pulling direction opposite to the first pulling direction.
  • the arrangement may be such that simultaneous actuation of the first and second actuators so as to move the advancement and displacement cable in opposite first and second pulling directions causes the advancing or retracting of the at least one infusion needle.
  • advancement and displacement cable when the advancement and displacement cable is arranged to move the above- mentioned translating frame along the above-mentioned linear bearing or bearings in the advancing and retracting directions, movement of the advancement and displacement cable in opposite first and second pulling directions may cause the translating frame to move along the linear bearing or bearings.
  • This may be achieved, for example, by means of at least two first pulleys fixed to the housing so as to be stationary, wherein the advancement and displacement cable is guided over one of the two first pulleys fixed to the housing, further to the translating frame and further over the other one of the two first pulleys fixed to the housing.
  • the translating frame is pulled along the linear bearing or bearings in a direction towards the two first pulleys, such as in the advancing direction of the infusion needle or needles.
  • the aforementioned block -and - tackle setup may likewise be provided for the advancement and displacement cable, this is not so important in this case, because here two motors instead of only one motor may be used, one at each end of the advancement and displacement cable, so that twice the amount of power is available.
  • the aforementioned return spring may be arranged to urge the translating frame towards a rest position so that, when the pulling force on the advancement and displacement cable is reduced, the return spring will cause automatic movement of the translating frame back into the rest position.
  • the arrangement may further be such that actuation of any one of the first and second actuators so as to move the advancement and displacement cable in the first or second pulling direction, while the respective other one of the first and second actuators is not caused to move the advancement and displacement cable, causes the displacement of the at least one infusion needle in the displacement direction.
  • the advancement and displacement cable may be connected to the needle cooperating member so as to pull and move the needle cooperating member along the cross guide into different positions in the displacement direction.
  • This may be achieved, for example, by means of at least two second pulleys fixed to the translating frame on opposed sides of the needle cooperating member, wherein the advancement and displacement cable is guided over the two second pulleys.
  • the advancement and displacement cable may comprise two separate cable sections, each cable section having one end thereof connected to the needle cooperating member.
  • the advancement and displacement cable may alternatively be continuous with a central portion thereof being fixedly connected to the needle cooperating member.
  • two motors in particular piezoelectric motors, may be arranged for, in cooperation, advancing or retracting the at least one infusion needle in the advancing or retracting direction and, individually, displacing the needle cooperating member in respectively opposite displacement directions.
  • the at least one infusion needle may comprise only a single infusion needle attached to the needle cooperating member so as to be movable in the displacement direction together with the needle cooperating member.
  • the single infusion needle may be welded or potted to the needle cooperating member and may have a curved section by which it is attached to the needle cooperating member, wherein the curved section may be fixedly held in a correspondingly curved recess of the needle cooperating member.
  • a needle-reinforcing tube may be placed around the single infusion needle to help minimize any deflection of the infusion needle when penetrating the penetration area of the housing’s wall, and a tubing for supplying the substance to be injected through the single infusion needle may be connected to an end of the single infusion needle and looped inside the housing to allow the tubing a required range of motion.
  • the at least one infusion needle may have a tubular needle body with a tip end, an injection port arranged at the tip end so as to allow for injecting the substance via the at least one infusion needle, a feeding port arranged distant from the tip end so as to allow for receiving the substance to be injected and a needle lumen inside the tubular needle body connecting the injection port with the feeding port, wherein the feeding port is a side port which is arranged on a side of the tubular needle body.
  • the substance to be injected is fed sideways into the needle body.
  • the supply lumen is not in conflict with the rear end of the needle, which end may be used and specifically adapted for moving the infusion needle in the advancing or retracting direction. While this aspect is certainly applicable in cases where only a single infusion needle is present so that only a single supply lumen is required, this aspect may advantageously be employed also in a system which comprises a plurality of infusion needles. In general, in cases where a plurality of needles is provided, the infusion needles may be spaced apart from each other by a distance of between 1 mm and 2 mm, preferably by a distance of 1.5 mm.
  • the system may comprise an internal reservoir inside the housing which is arranged for holding the substance to be injected, wherein, when the infusion needle is in an advanced position in which it penetrates the penetration area, the feeding port is positioned inside the internal reservoir and the injection port is positioned outside the housing. Accordingly, in this position the substance, such as an infusion liquid, may enter the infusion needle through the feeding port arranged on the side of the tubular needle body and, when an appropriate pressure is applied on the substance in the internal reservoir, the substance will flow from the internal reservoir through the feeding port, needle lumen and injection port into the patient.
  • the substance such as an infusion liquid
  • each of the infusion needles may be advanced individually into a position in which it penetrates the penetration area with its respective feeding port positioned inside the internal reservoir and its respective injection port positioned outside the housing.
  • the penetration area may comprise a septum and the internal reservoir may be arranged within the septum such that, when the infusion needle is in a retracted position, the feeding port is outside the internal reservoir and inside the septum.
  • the feeding port is hermetically closed by the material of the septum when the infusion needle is not in use and retracted.
  • the dimension of the internal reservoir inside the septum may be such that the feeding port is positioned inside the internal reservoir when the infusion needle is in the retracted position. This may be advantageous in order to ensure that the needle lumen is filled with substance from the internal reservoir before the infusion needle is moved from its retracted position to its advanced position.
  • each of the infusion needles is arranged in this way, preferably in a side-by-side arrangement.
  • the injection port at the tip end of the infusion needle or needles may be arranged inside the septum when the infusion needle is in the retracted position. This way, the injection port is safely protected. In this retracted position, the injection port may be arranged inside the septum and outside the internal reservoir. This way, again, also the injection port is hermetically closed by the material of the septum when the infusion needle is not in use and retracted. Furthermore, such arrangement increases the stability of the infusion needle and gives some guidance to the needle movement.
  • the injection port may be arranged inside the septum and inside the internal reservoir when the infusion needle is in the retracted position. Again, this may be advantageous in order to ensure that the needle lumen is already filled with substance from the internal reservoir before the infusion needle is moved from its retracted position to its advanced position.
  • the supply lumen for supplying the substance to be injected to the internal reservoir
  • the supply lumen may be arranged so as to run along an inner lumen of the linear bearing. This way the overall size of the housing may be kept small.
  • the inner lumen preferably connects directly to the aforementioned internal reservoir.
  • the injection port of the infusion needle is designed as a side port arranged on a side of the tubular needle body, as will be explained in more detail hereinafter.
  • the infusion needle may be closed at its tip end and the laterally arranged injection port is used for delivery of the drug into the particular body part. Therefore, the infusion needle will not cut out any material but will simply divide it during penetration.
  • any material such as fibrosis and/or the septum, which may be in the form of a self-sealing penetration membrane, there will be no material entering and blocking the drug delivery passageway.
  • the maximum size of the housing is preferably 30 mm x 40 mm x 6 mm.
  • the system is preferably configured such that at least one of: wireless communication from or to, or both from and to, a controller of the system is encrypted, data transmitted by a controller via wireless communication is signed, and authentication of a user of the system involves input of authentication data of the patient.
  • the encrypted wireless communication includes encryption with a public key and decryption with a private key, such as the well-known RSA encryption. Other encryption methods may likewise be implemented.
  • the security level is further increased in that the private key may be a combined key derived by combining at least a first key and a second key.
  • the signing may involve a private key, whereas subsequent verification of the signed data may involve a corresponding public key.
  • data communication involves both an encryption and a signature.
  • the RSA encryption technology allows for both, encrypting the data and adding a digital signature to the data.
  • the sender uses a public key of the recipient for encrypting the data and the recipient uses his private key for subsequently decrypting the data, whereas for the signing/authentication process, the sender uses his private key to sign the (encrypted) data and the recipient uses the sender’s public key to authenticate the signature.
  • the system may comprise a verification unit which is configured to obtain the authentication data of the patient.
  • the verification unit may comprise at least one of a fingerprint reader, a retina scanner, a camera, a graphical user interface for inputting a code, and a microphone. Only after a positive verification by the verification unit will certain functions of the system be enabled. For instance, the positive verification may enable the controller to process certain data or may open a communication channel between two controllers of the system, such as a wireless communication channel.
  • the system may comprise a sensation generator for generating a sensation which is detectable by a sense of the patient.
  • the patient may input into the system authentication data which relate to what the patient has sensed.
  • the authentication of the user may involve a verification by the verification unit that the authentication data input by the user matches data from the sensation generator which relate to the sensation generated by the sensation generator.
  • the positive verification may enable the controller to process certain data or may open a communication channel between two controllers of the system, such as a wireless communication channel.
  • the sensation generator may be configured to generate as the sensation detectable by the sense of the patient at least one of: a vibration, which may include e.g. a fixed-frequency mechanical vibration, a sound, which may include e.g. a superposition of fixed-frequency mechanical vibrations, a photonic signal, which may include e.g. a non-visible light pulse, such as an infrared pulse, a light signal, which may include e.g. a visual light pulse, an electrical signal, which may include e.g. an electrical current pulse, and a heat signal, which may include e.g. a thermal pulse.
  • a vibration which may include e.g. a fixed-frequency mechanical vibration
  • a sound which may include e.g. a superposition of fixed-frequency mechanical vibrations
  • a photonic signal which may include e.g. a non-visible light pulse, such as an infrared pulse
  • a light signal which may include e.g. a visual light pulse
  • an electrical signal which
  • an external device configured for the communication with the implantable medical device when implanted in a patient
  • the external device comprising: a display device and a housing unit configured to mechanically and disconnectably connect to the display device, wherein the housing comprises a first communication unit for receiving communication from the display device and a second communication unit for wirelessly transmitting communication to the implantable medical device.
  • the external device comprises a handheld electronic device.
  • the external device is configured for communicating with the implantable medical device for changing the operational state of an implantable medical device.
  • the advantage of the embodiment is that the operational state of the implantable medical device can be changed remotely.
  • the first communication unit is a wireless communication unit for wireless communication with the display device.
  • the advantage of the embodiment is that the display device can be communicated without the need of electric wires.
  • the first communication unit is configured to communicate wirelessly with the display device using a first communication frequency and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication frequency, wherein the first and second communication frequencies are different.
  • the second communication unit is configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 100 kHz.
  • the second communication unit is configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 40 kHz.
  • the advantage of the embodiment is that titanium, which is commonly used for medical devices, is transparent for electromagnetic waves below 40 kHz.
  • the first communication unit is configured to communicate wirelessly with the display device using electromagnetic waves at a frequency above 100 kHz.
  • the advantage of the embodiment is that the frequency spectrum below 100 kHz remains noise free for the communication with the medical implantable device.
  • the first communication unit is configured to communicate wirelessly with the display device using a first communication protocol and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication protocol, wherein the first and second communication protocols are different.
  • the advantage of the embodiment is that the protocol can be independently chosen for the communication of the first and second communication units, depending on which protocol suits the needs of the communication units better.
  • the housing unit comprises a first antenna configured for wireless communication with the display device and a second antenna configured for wireless communication with the implantable medical device.
  • the advantage of the embodiment is that the antenna can be independently chosen for the communication of the first and second communication units, depending on which antenna suits the needs of the communication units better.
  • the first communication unit is a wire-based communication unit for wire-based communication with the display device.
  • the advantage of the embodiment is that the communication of the first communication unit is reliable and secure.
  • the display device comprises a first communication unit for communication with the housing unit and a second communication unit for wireless communication with a second external device.
  • the advantage of the embodiment is that communication with an additional external device becomes possible, thereby introducing redundancy and reliability.
  • the second communication unit of the display device is configured for communicating with the second external device over the internet. The advantage of the embodiment is that the display device can communicate with devices far away.
  • the first communication unit of the display device is a wireless communication unit for wireless communication with the housing unit.
  • the advantage of the embodiment is that the communication unit can be connected to the housing unit without the use of wires.
  • the first communication unit of the display device is configured to communicate wirelessly with the housing unit using a first communication frequency and the second communication unit of the display device is configured to communicate wirelessly with the second external device using a second communication frequency, wherein the first and second communication frequencies are different.
  • the advantage of the embodiment is that the likelihood of interferences is reduced and the signal to interference and noise ratio is increased.
  • the first communication unit of the display device is configured to communicate wirelessly with the housing unit using a first communication protocol and the second communication unit of the display device is configured to communicate wirelessly with the second external device using a second communication protocol, wherein the first and second communication protocols are different.
  • the advantage of the embodiment is that the protocol can be independently chosen for the communication of the first and second communication units, depending on which protocol suits the needs of the communication units better.
  • the display device comprises a first antenna configured for wireless communication with the housing and a second antenna configured for wireless communication with the second external device.
  • the advantage of the embodiment is that the antenna can be independently chosen for the communication of the first and second communication units, depending on which antenna suits the needs of the communication units better.
  • the first communication unit is a wire-based communication unit for wire-based communication with the housing unit.
  • the advantage of the embodiment is that the communication of the first communication unit is reliable and secure.
  • the display device is configured to display a user interface to the patient.
  • the advantage of the embodiment is that the patient can use his familiar display device to communicate with the housing unit.
  • the housing unit is configured to transmit information pertaining to the display of the user interface to the display device.
  • the advantage of the embodiment is that the patient can receive information using his familiar display device.
  • the display device is configured to receive from the patient input pertaining to communication to or from the implantable medical device and transmit signals based on the received input to the housing unit.
  • the advantage of the embodiment is that the patient can use his familiar display device to communicate with the housing unit.
  • the display device comprises a touch screen configured to display the user interface and receive the input from the patient.
  • the advantage of the embodiment is that the patient can use a familiar way of handling the information.
  • the housing unit is configured to display a user interface to the patient.
  • the advantage of the embodiment is that the housing unit can receive user input.
  • the first communication unit of the housing unit is configured to receive communication from the implantable medical device pertaining to input from the patient and wirelessly transmit signals based on the received input to the implantable medical device, using the second communication unit.
  • the advantage of the embodiment is that the housing unit acts as an extra node in the communication between the display device and the medical implantable device, thereby enabling it to monitor the communication.
  • the second communication unit of the housing unit is configured for wireless communication with the implantable medical device using a standard network protocol.
  • the advantage of the embodiment is that the implementation of the communication units is cheap and the protocols are reliable.
  • the standard network protocol is one of the list of: Radio Frequency type protocol, RFID-type protocol, WLAN-type protocol, Bluetooth-type protocol, BLE- type protocol, NFC-type protocol, 3G/4G/5G-type protocol, and GSM-type protocol.
  • the second communication unit of the housing unit comprises a Bluetooth transceiver.
  • the second communication unit of the housing unit is configured for wireless communication with the implantable medical device using a proprietary network protocol.
  • the advantage of the embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.
  • the second communication unit of the housing unit comprises a UWB transceiver. The advantage is that high data rates can be communicated via the second communication unit.
  • the first communication unit of the housing unit is configured for wireless communication with the display device using a standard network protocol.
  • the advantage of the embodiment is that the implementation of the communication units is cheap and the protocols are reliable.
  • the standard network protocol is an NFC-type protocol.
  • the advantage of the embodiment is that the distance between the communicating devices is limited, thereby protecting against eavesdropping attacks.
  • the first communication unit of the housing unit is configured for wireless communication with the display device using a proprietary network protocol.
  • the advantage of the embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.
  • a communication range of the first communication unit of the housing unit is less than a communication range of the second communication unit of the housing unit.
  • a communication range of the first communication unit of the display device is less than a communication range of the second communication unit of the display device.
  • At least one of the housing unit and the display device is configured to allow communication between the housing unit and the display device on the basis of a distance between the housing unit and the display device.
  • the advantage of the embodiment is that the distance is used as a safety and authorization factor.
  • At least one of the housing unit and the display device is configured to allow communication between the housing unit and the display device on the basis of the housing unit being mechanically connected to the display device.
  • the advantage of the embodiment is that the safety against a man-in-the-middle attacks is increased.
  • the housing unit is configured to allow communication between the housing unit and the implantable medical device on the basis of a distance between the housing unit and the implantable medical device. The advantage of the embodiment is that the distance is used as a safety and authorization factor.
  • the housing unit further comprises an encryption unit configured to encrypt communication received from the display device.
  • an encryption unit configured to encrypt communication received from the display device.
  • the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit.
  • the advantage of the embodiment is that the encrypted communication is protected against unwanted third party access.
  • the second communication unit of the display device is configured to be disabled to enable at least one of: communication between the display device and the housing unit, and communication between the housing unit and the implantable medical device.
  • the display device in any of the embodiments described herein may be a wearable device or a handset.
  • the advantage of the embodiment is that the device is mobile and can be used where needed.
  • the housing unit comprises a case for the wearable device or handset.
  • the advantage of the embodiment is that the wearable device or handset can be protected from mechanical damage.
  • a housing unit configured for communication with the implantable medical device when implanted in a patient is provided, the housing unit being configured to mechanically connect to a display device and comprising a first communication unit for communication with the display device and a second communication unit for wireless communication with the implantable medical device.
  • the display device is a wearable device or a handset and the housing unit comprises a case for the wearable device or handset.
  • the first communication unit is a wireless communication unit for wireless communication with the display device.
  • the first communication unit is configured to communicate wirelessly with the display device using a first communication frequency and the second communication unit is configured to communicate wirelessly with the implantable medical device using a second communication frequency, wherein the first and second communication frequencies are different.
  • the housing unit is configured to transmit information pertaining to the display of a user interface to the display device.
  • the housing unit is configured to receive patient input from the display device.
  • the housing unit is configured to display a user interface to the patient.
  • the housing unit is configured to allow communication between the housing unit and the display device on the basis of a distance between the housing unit and the display device.
  • the housing unit is configured to allow communication between the housing unit and the display device on the basis of the housing unit being mechanically connected to the display device.
  • the housing unit is configured to allow communication between the housing unit and the implantable medical device on the basis of a distance between the housing unit and the implantable medical device.
  • the housing unit further comprises an encryption unit configured to encrypt communication received from the display device.
  • the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit.
  • the minimum bounding box of the housing unit and the display device, when the housing is mechanically connected to the display device is no more than 10 % wider, 10 % longer or 100 % higher than the minimum bounding box of the display device.
  • the housing unit comprises one or more switches configured to be used by the patient when the housing is not mechanically connected to the display device.
  • the switches are at least partly covered by the display device, when the display device is mechanically connected to the housing unit. [0146] According to one embodiment, at least a part of the housing bends in order to mechanically connect to the display device.
  • At least a part of the housing is configured to clasp the display device.
  • the housing is configured to cover at least one side of the display device when it is mechanically connected to the display device.
  • the housing is configured to be mechanically connected to the display device by a device which is mechanically connected to the housing and the display device.
  • an implantable controller for the implantable medical device comprises a wireless transceiver for communicating wirelessly with an external device, a security module, and a central unit configured to be in communication with the wireless transceiver, the security module and the implantable medical device.
  • the wireless transceiver is configured to receive communication from the external device including at least one instruction to the implantable medical device and transmit the received communication to the central unit.
  • the central unit is configured to send secure communication to the security module derived from the communication received from the external device, and the security module is configured to decrypt at least a portion of the secure communication and/or verify the authenticity of the secure communication.
  • the security module is configured to transmit a response communication to the central unit and the central unit is configured to communicate the at least one instruction to the implantable medical device, the at least one instruction being based on the response communication or on a combination of the response communication and the communication received from the external device.
  • the security module comprises a set of rules for accepting communication from the central unit.
  • the wireless transceiver is configured to be placed in an off- mode, in which no wireless communication can be transmitted or received by the wireless transceiver, and wherein the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the wireless transceiver is placed in the off-mode.
  • the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the wireless transceiver has been placed in the off-mode for a specific time period.
  • the central unit is configured to verify a digital signature of the received communication from the external device.
  • the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the digital signature of the received communication has been verified by the central unit.
  • the central unit is configured to verify the size of the received communication from the external device.
  • the set of rules comprises a rule stipulating that communication from the central unit is only accepted when the size of the received communication has been verified by the central unit.
  • the wireless transceiver of any of the preceding embodiments may be configured to receive a message from the external device being encrypted with at least a first and second layer of encryption and the central unit may be configured to decrypt a first layer of decryption and transmit at least a portion of the message comprising the second layer of encryption to the security model.
  • the security module may be configured to decrypt the second layer of encryption and transmit a response communication to the central unit based on the portion of the message decrypted by the security module.
  • the central unit may be configured to decrypt a portion of the message comprising a digital signature such that the digital signature can be verified by the central unit.
  • the central unit is configured to decrypt a portion of the message comprising message size information such that the message size can be verified by the central unit.
  • the central unit is configured to decrypt a first and second portion of the message, and the first portion comprises a checksum for verifying the authenticity of the second portion.
  • the response communication transmitted from the security module comprises a checksum, and the central unit may be configured to verify the authenticity of at least a portion of the message decrypted by the central unit using the received checksum.
  • the set of rules comprises a rule related to the rate of data transfer between the central unit and the security module.
  • the security module in any of the embodiments herein may be configured to decrypt a portion of the message comprising a digital signature, encrypted with the second layer of encryption, such that the digital signature can be verified by the security module.
  • the central unit may be configured such that it is only capable of decrypting a portion of the communication received from the external device when the wireless transceiver is placed in the off- mode.
  • the central unit is only capable of communicating the at least one instruction to the implantable medical device when the wireless transceiver is placed in the off- mode.
  • the implantable controller is configured to receive, using the wireless transceiver, a message from the external device comprising a first non-encrypted portion and a second encrypted portion, decrypt the encrypted portion, and use the decrypted portion to verify the authenticity of the non-encrypted portion.
  • the central unit is configured to transmit the encrypted portion to the security module, receive a response communication from the security module based on information contained in the encrypted portion being decrypted by the security module, and use the response communication to verify the authenticity of the non-encrypted portion.
  • the non-encrypted portion comprises at least a portion of the at least one instruction to the implantable medical device.
  • the implantable controller may be configured to receive, using the wireless transceiver, a message from the external device comprising information related to at least one of a physiological parameter of the patient and a physical parameter of the implanted medical device and use the received information to verify the authenticity of the message.
  • the physiological parameter of the patient may comprise at least one of: a temperature, a heart rate and a saturation value.
  • the physical or functional parameter of the implanted medical device may comprise at least one of: a current setting or value of the implanted medical device, a prior instruction sent to the implanted medical device and an ID of the implanted medical device.
  • the portion of the message comprising the information is encrypted, and the central unit is configured to transmit the encrypted portion to the security module and receive a response communication from the security module based on the information having been decrypted by the security module.
  • the security module comprises a hardware security module comprising at least one hardware -based key.
  • the hardware-based key may correspond to a hardwarebased key in the external device, which may be a hardware -based key on a key-card connectable to the external device.
  • the security module comprises a software security module comprising at least one software-based key.
  • the software-based key may correspond to a softwarebased key in the external device.
  • the software-based key may correspond to a software -based key on a key-card connectable to the external device.
  • the security module may in any of the embodiments comprise a combination of a software-based key and a hardware-based key.
  • the implantable controller may comprise at least one crypto-processor.
  • the wireless transceiver may in any of the embodiments be configured to receive communication from a handheld external device.
  • the at least one instruction to the implantable medical device may comprise an instruction for changing an operational state of the implantable medical device.
  • the wireless transceiver may be configured to communicate wirelessly with the external device using electromagnetic waves at a frequency below 100 kHz or at a frequency below 40 kHz.
  • the wireless transceiver is configured to communicate wirelessly with the external device using a first communication protocol
  • the central unit is configured to communicate with the security module using a second different communication protocol.
  • the wireless transceiver may be configured to communicate wirelessly with the external device using a standard network protocol.
  • the standard network protocol may be selected from a list comprising RFID-type protocols, WLAN-type protocols, Bluetooth type protocols, BLE-type protocols, NFC-type protocols, 3G/4G/5G-type protocols, and GSM-type protocols.
  • the wireless transceiver may in some embodiments be configured to communicate wirelessly with the external device using a proprietary network protocol.
  • the wireless transceiver comprises a UWB transceiver.
  • the security module and/or the central unit and/or the wireless transceiver are comprised in the controller.
  • the external unit in any of the embodiments herein may be a wearable device or a handset.
  • the advantage of the embodiment is that the device is mobile and can be used where needed.
  • the implantable medical device may comprise a receiving unit.
  • the implantable medical device comprises at least one coil configured for receiving transcutaneously transferred energy, a measurement unit configured to measure a parameter related to the energy received by the coil, a variable impedance electrically connected to the coil, a switch placed between the variable impedance and the coil for switching off the electrical connection between the variable impedance and the coil.
  • the implantable medical device further comprises a controller configured to control at least one of the variable impedance for varying the impedance and thereby tune the coil based on the measured parameter, and the switch for switching off the electrical connection between the variable impedance and the coil in response to when the measured parameter exceeds a threshold value.
  • the controller is configured to vary the variable impedance in response to when the measured parameter exceeds a threshold value.
  • the measurement unit is configured to measure a parameter related to the energy received by the coil over a time period.
  • the measurement unit is configured to measure a parameter related to a change in energy received by the coil.
  • the first switch is placed at a first end portion of the coil
  • the implantable medical device further comprises a second switch placed at a second end portion of the coil such that the coil can be completely disconnected from other portions of the implantable medical device.
  • the receiving unit is configured to receive transcutaneously transferred energy in pulses according to a pulse pattern
  • the measurement unit is configured to measure a parameter related to the pulse pattern.
  • the controller is configured to control the variable impedance in response to when the pulse pattern deviates from a predefined pulse pattern.
  • the controller is configured to control the switch for switching off the electrical connection between the variable impedance and the coil in response to the pulse pattern deviating from a predefined pulse pattern.
  • the measurement unit is configured to measure a temperature in the implantable medical device or in the body of the patient, and the controller is configured to control the first and second switch in response to the measured temperature.
  • variable impedance comprises a resistor and a capacitor, a resistor and an inductor and/or an inductor and a capacitor.
  • variable impedance may comprise a digitally tuned capacitor.
  • the variable impedance may comprise a digital potentiometer.
  • the variable impedance may comprise a variable inductor.
  • the variation of the impedance is configured to lower the active power that is received by the receiving unit.
  • variable impedance is placed in series with the coil.
  • variable impedance is placed parallel to the coil.
  • the implantable medical device further comprises an energy storage unit connected to the receiving unit.
  • the energy storage unit is configured to store energy received by the receiving unit.
  • Another aspect of the present disclosure relates to the mitigation of fibrin creation caused by contact between a medical implant, such as the above-discussed implantable system, and the tissue or flowing blood of a patient.
  • a medical implant such as the above-discussed implantable system
  • the body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body and/or blood flowing within the body.
  • Implantation of medical devices and/or biomaterial in the tissue of a patient may trigger the body’s foreign body reaction leading to the formation of foreign body giant cells and the development of a fibrous capsule enveloping the implant.
  • the formation of a dense fibrous capsule that isolates the implant from the host is the common underlying cause of implant failure.
  • Implantation of medical devices and/or biomaterial in a blood flow may also cause the formation of fibrous capsules due to the attraction of certain cells within the blood stream. Implants may, due to the fibrin formation, cause blood clotting leading to complications for the patient. Implants in contact with flowing blood and/or placed in the body may also lead to bacterial infection.
  • One common way of counteracting the creation of blood clots is by using blood thinners of different sorts. One commonly used blood thinner is called heparin. However, heparin has certain side effects that are undesirable.
  • fibrin is an insoluble protein that is partly produced in response to bleeding and is the major component of blood clots. Fibrin is formed by fibrinogen, a soluble protein that is produced by the liver and found in blood plasma. When tissue damage results in bleeding, fibrinogen is converted at the wound into fibrin by the action of thrombin, a clotting enzyme. The fibrin then forms, together with platelets, a hemostatic plug or clot over a wound site. The process of forming fibrin from fibrinogen starts with the attraction of platelets. Platelets have thrombin receptors on their surfaces that bind serum thrombin molecules. These molecules can in turn convert soluble fibrinogen into fibrin.
  • the fibrin then forms long strands of tough and insoluble protein bound to the platelets.
  • the strands of fibrin are then cross-linked so that it hardens and contracts. This is enabled by Factor XIII which is a zymogen found in the blood of humans.
  • Fibrin may also be created due to the foreign body reaction. When a foreign body is detected in the body, the immune system will become attracted to the foreign material and attempt to degrade it. If this degradation fails, an envelope of fibroblasts may be created to form a physical barrier to isolate the body from the foreign body. This may further evolve into a fibrin sheath. In case the foreign body is an implant, this may hinder the function of the implant.
  • implants can, when implanted in the body, be in contact with flowing blood. This may cause platelet adhesion on the surface of the implants. The platelets may then cause the fibrinogen in the blood to convert into fibrin creating a sheath on and/or around the implant. This may prevent the implant from working properly and may also create blood clots that are perilous for the patient.
  • implants not in contact with flowing blood can still malfunction due to fibrin creation.
  • the foreign body reaction may be the underlying factor for the malfunction.
  • the implantation of a foreign body into the human body may cause an inflammatory response. The response generally persists until the foreign body has been encapsulated in a relatively dense layer of fibrotic connective tissue which protects the human body from the foreign body.
  • the process may start with the implant immediately and spontaneously acquiring a layer of host proteins.
  • the blood protein -modified surface enables cells to attach to the surface, enabling monocytes and macrophages to interact on the surface of the implant.
  • the macrophages secrete proteins that modulate fibrosis and in turn develop the fibrosis capsule around the foreign body, i.e., the implant.
  • a fibrosis capsule may be formed of a dense layer of excess fibrous connective tissue.
  • the inelastic properties of the fibrotic capsule may lead to hardening, tightness, deformity, and distortion of the implant, which in severe cases may result in revision surgery.
  • Implants may also cause infections of different sorts. Bacterial colonization that leads to implant-associated infections are a known issue for many types of implants. For example, the commensal skin bacteria, Staphylococci, and the Staphylococcus aureus tend to colonize foreign bodies such as implants and may cause infections. A problem with the Staphylococci is that it may also produce a biofilm around the implant encapsulating the bacterial niche from the outside environment. This makes it harder for the host defense systems to take care of the bacteria. There are other examples of bacteria and processes that creates bacteria causing infection due to implants.
  • the implantable components of the system may comprise a specific coating arranged on the respective outer surface of the component.
  • the coating may comprise at least one layer of a biomaterial.
  • the biomaterial is preferably fibrin -based.
  • the coating may comprise at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.
  • the drug or substance may be encapsulated in a porous material.
  • the second coating may be a different biomaterial than said first coating.
  • the first coating may comprise a layer of perfluorocarbon chemically attached to the surface and the second coating may comprise a liquid perfluorocarbon layer.
  • the surface may comprise a metal, such as at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.
  • the surface may comprise a micro pattern, wherein the micro pattern may be etched into the surface prior to insertion into the body.
  • the layer of a biomaterial may be coated on the micro pattern.
  • a further aspect of the present disclosure relates to the manner of securely injecting drugs into a vessel of the patient, in particular into a blood vessel, for instance into an artery or a vein, using a system according to any one of the embodiments disclosed herein, i.e. involving an infusion needle which is advanced into and retracted from the vessel.
  • the infusion needle may comprise an injection port on a side surface thereof.
  • said injection port is spaced apart from the tip end of the at least one infusion needle by less than 2 mm, more preferably less than 1 mm, even more preferably between 0.5 and 1 mm. This is particularly helpful in situations where the vessel to be pierced has a small diameter.
  • the injection port is a side port and being arranged very close to the tip end of the infusion needle, the infusion needle needs to be advanced into the vessel only over a very short distance in order for placing the injection port inside the vessel, thereby preventing that the tip end of the infusion needle extends through and out of the vessel wall on the opposite side of the vessel.
  • the above-mentioned spacing relates to the distance between the tip end of the infusion needle and the end of the injection port closest to the tip end.
  • the injection port preferably has an extension of not more than 0.5 mm in a longitudinal direction of the infusion needle, more preferably not more than 0.3 mm, even more preferably not more than 0.2 mm.
  • the injection port may have an extension in a direction transverse to the longitudinal direction of the infusion needle which is greater than an extension of the injection port in the longitudinal direction of the infusion needle.
  • the at least partly implantable system for injecting a substance into a patient’s body may comprise: a housing adapted for implantation inside the patient’s body, the housing having an outer wall with a penetration area, at least one infusion needle disposed in the housing, and a drive unit arranged for advancing and retracting the at least one infusion needle in opposite advancing and retracting directions so that a tip end of the at least one infusion needle penetrates, upon advancement of the at least one infusion needle, said penetration area so as to allow for injecting the substance through said penetration area via the at least one infusion needle, wherein the infusion needle is designed as stated above, i.e.
  • injection port on a side surface of the at least one infusion needle, said injection port being spaced apart from the tip end of the at least one infusion needle by less than 2 mm preferably less than 1 mm, more preferably between 0.5 and 1 mm, and preferably having an extension of not more than 0.5 mm in a longitudinal direction of the infusion needle, more preferably not more than 0.3 mm, even more preferably not more than 0.2 mm, and further preferably having an extension in a direction transverse to a longitudinal direction of the infusion needle which is greater than an extension of the injection port in the longitudinal direction of the infusion needle.
  • the injection needle may be arranged so that it enters, upon advancement, into the vessel in an inclined manner, i.e. non -vertically.
  • This can be achieved by arranging the infusion needle such that it does not extend from the housing vertically, when advanced, but extends at an inclined angle relative to an outer surface of the housing.
  • the outer wall of the housing of the implantable system may have an outer surface which extends in a first direction and which is configured so that a longitudinal vessel, such as a vein or an artery, is placeable adjacent said outer surface in such a manner that a central axis of the longitudinal vessel extends in parallel to said first direction.
  • the infusion needle enters, upon advancement, the vessel at such an inclination angle.
  • the infusion needle is arranged inside the housing angularly with respect to the housing’s outer wall, more specifically with respect to the outer surface of the housing’s outer wall.
  • the infusion needle is preferably inclined relative to the outer wall of the housing by an inclination angle which is smaller than 90° and preferably in a range of 10° and 80°, more preferably in a range of 20° to 40°.
  • the infusion needle may be configured to inject into the blood vessel inside the patient’s body with a side of the at least one infusion needle closest to the blood vessel being configured to inject with an angle a of less than 45° towards the blood vessel length axis. More specifically, the infusion needle preferably has a chamfer towards the tip end, wherein the chamfer is placed towards the blood vessel and an angle [3 between the blood vessel and the chamfer is at least 15°.
  • the infusion needle is preferably arranged to inject into a blood vessel inside the patient’s body with a side of the needle closest to the blood vessel being configured to inject with less than 45° angle towards the blood vessel length axis and/or the infusion needle may have a chamfer towards the tip end and may be configured to inject into a blood vessel inside the patient’s body with a side of the infusion needle closest to the blood vessel being configured to inject with less than 45° angle towards the blood vessel length axis, wherein the chamfer is placed towards the blood vessel and an angle between the blood vessel and the chamfer is at least 15°.
  • each of the at least two infusion needles is preferably liquid-tightly sealed against the at least one tubular opening, and the at least two infusion needles may be configured to inject into the blood vessel inside the patient’s body with a side of the at least two infusion needles closest to the blood vessel being configured to inject with less than 45° angle towards the blood vessel length axis.
  • the at least one infusion needle may further be configured to inject into one of the following: a blood vessel inside the patient’s body with a side of the at least one infusion needle closest to the blood vessel being configured to inject with less than 45° angle towards the blood vessel length axis, fat tissue by penetrating any fibrotic tissue build-up around the at least one infusion needle, muscle tissue by penetrating any fibrotic tissue build-up around the at least one infusion needle.
  • a holder that is configured to hold, when the at least one infusion needle is being advanced, the longitudinal vessel in position relative to the housing such that the central axis of the vessel extends in parallel to said first direction of the outer surface of the housing’s outer wall.
  • the holder ensures, on the one hand, that the vessel is correctly positioned and, on the other hand, that the vessel cannot move away, when it is being pierced by the infusion needle.
  • the holder is configured to enclose a section of the longitudinal vessel either partly or preferably about its entire circumference, namely in manner so that the vessel cannot escape from the holder.
  • the holder may comprise a movable lid configured to open and close the holder for placing and holding said section of the longitudinal vessel inside the holder.
  • the first direction may change in a curve. That is, as mentioned above, the outer surface of the housing may extend in a first direction and may be configured so that a longitudinal vessel can be placed adjacent said outer surface. If the first direction changes in a curve, i.e. if the surface along which the vessel is placed is curved in an appropriate direction, then the tip end of the infusion needle being advanced through a vessel wall into the vessel is less likely to pierce through an opposing vessel wall upon further advancement.
  • the at least partly implantable system for injecting a substance into a patient’s body may comprise: a housing (or casing) adapted for implantation inside the patient’s body, the housing having an outer wall with a penetration area, at least one infusion needle disposed in the housing so as to penetrate the penetration area and configured for being advanced and retracted in opposite advancing and retraction directions between an advanced position and a retracted position, wherein the system is adapted to inject the substance into the patient’s body via the at least one infusion needle when the infusion needle is in the advanced position, and wherein injection of the substance into the patient’s body via the at least one infusion needle is not possible when the infusion needle is in the retracted position, and a drive unit may be arranged for advancing and retracting the at least one infusion needle in the opposite advancing and retracting directions so that a tip end of the at least one infusion needle penetrates, upon advancement of the at least one infusion needle, said penetration area so as to allow for injecting the substance through
  • the inclined needle is a curved needle. More specifically, at least a tip end section of the infusion needle, which is a section including the tip end of the infusion needle, is curved in a plane of curvature.
  • a curved needle is similar to the effect of the curved surface along which the vessel is placed, as described above. Namely, if the curved needle is advanced into the vessel by rotating the infusion needle about an axis which may substantially correspond with an axis about which the tip end section of the infusion needle is curved, then the tip end of the infusion needle being advanced through a vessel wall into the vessel is less likely to pierce through an opposing vessel wall upon further advancement.
  • advancement and retraction of the infusion needle in the advancing and retraction directions preferably comprises rotation of the tip end section of the infusion needle about an axis of rotation which is vertical to the plane of curvature. It is further preferred to combine the curved surface along which the vessel is placed with the curved needle.
  • a second effect is that the housing in which the rotatable curved needle is housed may be designed smaller as compared to a housing in which one or more straight infusion needles are accommodated which are longitudinally displaceable in the infusion needle’s advancing and retraction directions.
  • the at least partly implantable system for injecting a substance into a patient’s body may comprise an at least partly implantable system for injecting a substance into a patient’s body, comprising: a housing or casing adapted for implantation inside the patient’s body, the housing or casing having an outer wall with a penetration area, at least one infusion needle disposed in the housing or casing so as to penetrate the penetration area and configured for being advanced and retracted in opposite advancing and retraction directions between an advanced position and a retracted position, wherein the system is adapted to inject the substance into the patient’s body via the at least one infusion needle when the infusion needle is in the advanced position, and wherein injection of the substance into the patient’s body via the at least one infusion needle is not possible when the infusion needle is in the retracted position, wherein the infusion needle is inclined relative to the outer wall by an inclination angle in a range of 10° and 80° and wherein at least a tip end section of the at least one in
  • An even further aspect of the present disclosure relates to a problem which may arise when an infusion needle has an injection port on a side surface thereof.
  • the injection needle creates a hole in the diaphragm and the injection port on the side surface of the infusion needle moves along the material from which the diaphragm is made, such as silicon material or any other polymeric material. This may cause some scratching and, consequently, abrasion of the diaphragm material and transport thereof into the patient’s body.
  • the system may be configured such that, when the at least one infusion needle is in a retracted position, the tip end of the infusion needle is arranged in a tube, wherein an inner surface of the tube and an outer surface of the infusion needle are liquid-tightly sealed against each other.
  • a sealing of the injection port namely in a manner such that fluid ingress, such as blood ingress, through the tube and further into the injection port is securely prevented.
  • an inner diameter of the inner surface of the tube and an outer diameter of the outer surface of the at least one infusion needle match each other so as to liquid-tightly seal against each other in order to prevent fluid ingress through the tube and into the injection port.
  • the sealing surfaces are constituted by these two surfaces.
  • the injection port is arranged in this sealing section of the infusion needle.
  • one or preferably both of the inner surface of the tube and the outer surface of the infusion needle - preferably comprising the section where the injection port is arranged - is made of ceramic material. Ceramics can be manufactured with high precision so as to provide mutually opposing sliding surfaces with small tolerances, thereby allowing to produce a liquid-tight fit between said inner and outer surfaces. Then, when the infusion needle and its injection port are advanced from the tube so as to extend from the housing, the needle does not need to pinch a hole into the housing’s wall in order to penetrate it.
  • the hole is already provided in the wall by the tube within which the tip end of the infusion needle resides. This reduces the risk that material is scraped off of the wall by means of an edge of the injection port’s opening when the infusion needle is being advanced. While the tube has one end which is open to the exterior of the housing at the time when the infusion needle is in its retracted position, there is no danger that any kind of body fluid or fibrosis can get into the needle or block the needle, because of the inner surface of the tube and outer surface of the infusion needle being liquid-tightly sealed against each other or liquid tightly sealing against each other.
  • the at least partly implantable system for injecting a substance into a patient’s body may comprise: a housing adapted for implantation inside the patient’s body, the housing having an outer wall with a penetration area, at least one infusion needle disposed in the housing, and a drive unit arranged for advancing and retracting the at least one infusion needle in opposite advancing and retracting directions so that a tip end of the at least one infusion needle penetrates, upon advancement of the at least one infusion needle, said penetration area so as to allow for injecting the substance through said penetration area via the at least one infusion needle, wherein an injection port is provided on a side surface of the at least one infusion needle and wherein, when the at least one infusion needle is in a retracted position, the tip end of the infusion needle is arranged in
  • an inner diameter of the inner surface of the tube and an outer diameter of the outer surface of the at least one infusion needle match each other so as to liquid-tightly seal against each other in order to prevent fluid ingress through the tube and further into the injection port, wherein more preferably one or both of the inner surface of the tube and the outer surface of the at least one infusion needle, preferably including a section of the infusion needle comprising the injection port, is made of ceramic material.
  • the penetration area of the housing’s outer wall to be penetrated by the infusion needle may be made at least partly of an elastic material in which a passage is pre-configured for the at least one infusion needle to pass through, said passage being normally closed by resilient forces that are generated by the elasticity of the elastic material, such as silicone or any other elastic polymeric material.
  • the elastic material such as silicone or any other elastic polymeric material.
  • the passage may automatially open by the tip end of the infusion needle diving into the passage, thereby expanding it to open. This reduces the risk that material is scraped off of the wall by means of an edge of the injection port’s opening when the infusion needle is being advanced.
  • the passage has a widened entrance section facing towards the housing.
  • the passage is normally open for the at least one infusion needle to enter into the passage when it is being advanced. This facilitates the insertion of the infusion needle into and further through the passage.
  • the tip end of the infusion needle may reside inside the passage when the infusion needle is in its retracted position. This avoids the need to properly feed the infusion needle into the passage when it is being advanced. This is, however, only an option forthose embodiments where the tip end of the infusion needle is moved forward and backward but not laterally between successive infusions.
  • the passage is configured as a slit having a lengthwise extension through the wall and a widthwise extension.
  • Such slit may be compressed by acting upon opposite sides of the elastic material in opposite directions of the slit’s widthwise extension so that the slit opens up, thereby opening the passage for the at least one infusion needle when the infusion needle is being advanced.
  • a compressor is operatively connected with the infusion needle and is arranged to compress the slit along its widthwise extension when the needle is beeing advanced.
  • the at least partly implantable system for injecting a substance into a patient’s body may comprise: a housing adapted for implantation inside the patient’s body, the housing having an outer wall with a penetration area, at least one infusion needle disposed in the housing, and a drive unit arranged for advancing and retracting the at least one infusion needle in opposite advancing and retracting directions so that a tip end of the at least one infusion needle penetrates, upon advancement of the at least one infusion needle, said penetration area so as to allow for injecting the substance through said penetration area via the at least one infusion needle, wherein said penetration area is at least partly made of an elastic material in which a passage is preconfigured for the at least one infusion needle to pass through, said passage being normally closed by resilient forces that are generated by the elasticity of the elastic material, wherein preferably the passage has a widened entrance section where the passage is normally open for the at least one infusion needle to enter into the passage and/or the passage opens automatically for the at least one infusion needle to pass
  • an infusion needle the injection port of which being again provided on a side surface thereof and, here, having a rounded or beveled edge at a transition between the injection port and the side surface.
  • the edge surrounding the injection port on the outer surface of the injection needle may be rounded or beveled. This way, sharpness of the edge is reduced, thereby reducing the risk that material is scraped off by means of an edge of the injection port’s opening when the infusion needle is being advanced.
  • the rounded or beveled edge is provided at least on opposite sides of the injection port, wherein a hypothetical connecting line between said opposite sides of the injection port extends along the advancing and retracting directions of the infusion needle. These are the areas of the injection port where scraping off of material by means of the injection port’s outer edge occurs most.
  • an at least partly implantable system for injecting a substance into a patient’s body may comprise: a housing adapted for implantation inside the patient’s body, the housing having an outer wall with a penetration area, at least one infusion needle disposed in the housing, and a drive unit arranged for advancing and retracting the at least one infusion needle in opposite advancing and retracting directions so that a tip end of the at least one infusion needle penetrates, upon advancement of the at least one infusion needle, said penetration area so as to allow for injecting the substance through said penetration area via the at least one infusion needle, wherein an injection port is provided on a side surface of the at least one infusion needle, said injection port having a rounded or beveled edge at a transition between the injection port and the side surface, wherein preferably the rounded or beveled edge is provided at least on opposite sides of the injection port, wherein a hypothetical connecting line between said opposite sides of the injection port extends along the advancing and retracting directions of the infusion needle.
  • an injection port on the side of the infusion needle is obviated. Instead, the injection port is provided in a front side of the tip end of the infusion needle, in the usual way, through which the substance is dispensable to the outside of the infusion needle.
  • a stylet is provided which is movable within the hollow body of the infusion needle between an advanced position, in which the stylet is so far advanced inside the hollow body that it closes the injection port so as to prevent fibrosis from growing into the infusion needle when the infusion needle is implanted in a patient, and a retracted position, in which the stylet is - at least - so far retracted inside the hollow body that a pathway is open for the substance to flow through the hollow body out of the injection port.
  • a main advantage of the stylet closing the injection port is not only that it prevents fibrosis from growing into the infusion needle but also that the infusion needle cannot cut out any material from the penetration area, i.e. a diaphragm or septum or membrane, through which the infusion needle passes with its tip end upon advancement of the infusion needle from its retracted position to it advanced position.
  • the stylet may even extend from the tip end of the at least one infusion needle.
  • the tip end of the stylet is the part which cuts through the penetration area, so that only the tip end of the stylet needs to be sharp, whereas the tip end of the needle body may be blunt. This may reduce the risk of tissue damage in cases where the needle stays advanced into the patient’s body over a longer time period.
  • the stylet in its retracted position, may even be retracted out of the hollow body of the infusion needle so that it disengages from the infusion needle, but it is preferable when the tip end of the stylet remains in the hollow body when the stylet is in its fully retracted position in order to facilitate its re-insertion into the infusion needle and in order to provide a seal against leakage of drugs from the infusion needle when the drugs are injected through the infusion needle into the patient’s body.
  • a feeding port may be provided in a side wall of the hollow body so as to allow for the substance to be fed through the feeding port into the hollow.
  • the tip end of the infusion needle penetrates, upon advancement of the infusion needle, said penetration area, i.e. membrane, septum, diaphragm, etc.
  • said penetration area i.e. membrane, septum, diaphragm, etc.
  • the infusion needle having the injection port in the front side of the tip end of the infusion needle and a stylet within the hollow body of the infusion needle which closes the injection port so as to prevent fibrosis from growing into the infusion needle when the infusion needle is implanted in a patient, offers further possibilities in that the needle need not be retracted entirely back into the housing.
  • the tip end of the infusion needle may extend from the penetration area when the infusion needle is in its retracted position.
  • protection walls may be provided on the housing, preferably on opposite sides of the tip end of the infusion needle, so as to prevent the tip end to get into contact with tissue of the patient when the at least one infusion needle is in its retracted position.
  • the tip ends of the infusion needles may be provided between two longitudinal walls, e.g. in a groove provided on the outer surface of the housing.
  • the septum may be configured such that it is movable in a lateral direction along with the at least one infusion needle when the at least one infusion needle is displaced laterally. This way, any fibrosis forming on both the infusion needle and the septum would move along with the infusion needle and septum when the infusion needle and septum are moved laterally for variation of the injection site.
  • the above-mentioned protection walls protecting the tip end of the infusion needle may be provided also in this situation.
  • an at least partly implantable system for injecting a substance into a patient’s body may comprise: a housing adapted for implantation inside the patient’s body, the housing having an outer wall with a penetration area, at least one infusion needle disposed in the housing so as to penetrate the penetration area, and a drive unit may be arranged for advancing and retracting the at least one infusion needle in opposite advancing and retraction directions between an advanced position and a retracted position, wherein the system is adapted to inject the substance into the patient’s body via the at least one infusion needle when the infusion needle is in the advanced position, and wherein injection of the substance into the patient’s body via the at least one infusion needle is not possible when the infusion needle is in the retracted position, wherein the infusion needle comprises: a tip end and a hollow body, wherein - preferably - a feeding port is provided in a side wall of the hollow body so as to allow for the substance to be fed through the feeding port into the hollow body and wherein an
  • the present disclosure also relates to the infusion needle with stylet as such, i.e. independent of the system, because the principle of the infusion needle with stylet can also be used in the other embodiments of the present disclosure if those embodiments are adapted accordingly.
  • such an infusion needle comprises a tip end and a hollow body, wherein a feeding port is provided in a side wall of the hollow body so as to allow a substance to be fed through the feeding port into the hollow body and wherein an injection port is provided in a front side of the tip end through which the substance is dispensable to the outside of the infusion needle, and a stylet which is movable within the hollow body between an advanced position, in which the stylet is so far advanced inside the hollow body that it closes the injection port so as to prevent fibrosis from growing into the infusion needle when the infusion needle is implanted in a patient, and a retracted position, in which the stylet is so far retracted inside the hollow body that a pathway is open for the substance to travel from the feeding port and through the hollow body out of the injection port, wherein, in the advanced position of the stylet, the stylet may extend from the tip end of the infusion needle, in which case the stylet may be sharp for piercing through tissue of the patient when the infusion needle
  • At least a tip end section of the infusion needle i.e. a section of the infusion needle comprising the tip end of the infusion needle, may be curved in a plane of curvature, i.e. the infusion needle is a curved needle.
  • a curved needle is particularly advantageous in connection with systems for injecting a substance into a patient’s having an inclined injection needle, as described further above.
  • Some preferred embodiments of the present disclosure relating to an at least partly implantable system for injecting a substance into a patient’s body comprise such a curved needle with further comprises stylet.
  • Those systems which employ a curved needle with a stylet may comprise a needle arm to which the infusion needle is mounted and a stylet arm to which the stylet is mounted, wherein the needle arm and the stylet arm are rotatable about a common axis of rotation.
  • the infusion needle and its stylet can be rotated together and/or individually, i.e. they can be advanced and retracted between respective advanced and retracted positions.
  • a conduit may be connected to the needle arm for supplying the substance to the needle.
  • the conduit is flexible so as to enable the conduit to follow movement of the needle arm.
  • the system may comprise a drive unit for carrying out at least the following steps, in sequence: advancing the infusion needle and stylet by rotating the needle arm jointly with the stylet arm about the common axis of rotation in the advancing direction, retracting the stylet inside the infusion needle towards its retracted position by rotating the stylet arm about the common axis of rotation in the retraction direction, retracting the infusion needle by rotating the needle arm about the common axis of rotation in the retraction direction.
  • the infusion needle When in this sequence of steps the infusion needle is retracted back into the housing without reinserting the stylet into the needle body beforehand, there may be a risk that some body fluid or blood drops from the retracted needle into the housing. This is, of course, not a problem in those embodiments where the infusion needle is not retracted entirely back into the housing, namely where at least the tip end of the infusion needle is not retracted into the interior of the housing.
  • the drive is preferably further configured to advance, before retraction of the infusion needle, the stylet inside the infusion needle by rotating the stylet arm about the common axis of rotation in the advancing direction.
  • the drive unit may comprise a first drive shaft which extends from the housing (or casing), the first drive shaft being configured to rotate the needle arm and the stylet arm about the common axis of rotation.
  • Certain mechanism may be provided in order to ensure that the above sequence of steps is realized, i.e. that the needle arm and the stylet arm are at some times rotated together and at other times rotated individually, such as a releasable holder, a clutch, a cam drive and the like, as will be described hereinafter,
  • the needle arm and stylet arm are mounted on a carriage which is movable inside the housing (or casing) so as to laterally move the tip end of the at least one infusion needle between different lateral positions.
  • a second drive shaft extending from the housing or casing may be provided to move the carriage inside the housing or casing so as to laterally move the at least one infusion needle between the different lateral positions.
  • an at least partly implantable system for injecting a substance into a patient’s body which system comprises a curved needle with stylet, may comprise: a housing or casing adapted for implantation inside the patient’s body, the housing or casing having an outer wall with a penetration area, at least one infusion needle disposed in the housing or casing so as to penetrate the penetration area and configured for being advanced and retracted in opposite advancing and retraction directions between an advanced position and a retracted position, wherein the system is adapted to inject the substance into the patient’s body via the at least one infusion needle when the infusion needle is in the advanced position, and wherein injection of the substance into the patient’s body via the at least one infusion needle is not possible when the infusion needle is in the retracted position, wherein at least a tip end section of the at least one infusion needle, which is a section including a tip end of the at least one infusion needle, is curved in a plane of curvature, with the tip end inclined relative
  • One mechanism to ensure that the needle arm and the stylet arm are at some times rotated together and at other times rotated individually may involve a drive unit with a biasing element and releasable holder, as described hereinafter.
  • the biasing element provides a biasing force which urges the needle arm and the stylet arm apart from each other, whereas the releasable holder is configured to hold the needle arm and stylet arm close to each other against the biasing force of the biasing element.
  • a release is arranged to release the releasable holder, when the infusion needle reaches or has reached its advanced position, such that the stylet arm is moved apart from the needle arm due to the biasing force of the biasing element.
  • the biasing element may be a torque spring. But other biasing elements are also possible, such springs of other type or biasing elements providing magnetic and/or electro -magnetic forces, to name only a few. However, torque springs are preferred fortheir simplicity. Preferably, the torque spring has a square or rectangular cross-section so as to provide maximum force on a minimum of space.
  • One end of the torque spring may be attached to the stylet arm and another end of the torque spring may be attached to the needle arm so as to urge the two arms apart from each other.
  • one end of the torque spring may be attached to the stylet arm and another end of the torque spring may be attached to the housing or casing or, where the needle arm and stylet arm are mounted on a carriage which is movable inside the housing or casing so as to laterally move the tip end of the at least one infusion needle between different lateral positions, to the carriage.
  • the releasable holder may comprise a flexible hook by which the needle arm and stylet arm are hooked together when the stylet arm rotates jointly with the needle arm about the common axis of rotation in the advancing direction, whereas the release is a deflector configured to deflect the flexible hook sideways so as to unhook the flexible hook when the infusion needle reaches or has reached its advanced position.
  • the infusion needle is retracted back into the housing without reinserting the stylet into the needle body beforehand. As mentioned before, this may create the risk that some body fluid or blood drops from the retracted needle into the housing.
  • the drive should preferably be configured to advance the stylet inside the infusion needle, by rotating the stylet arm about the common axis of rotation in the advancing direction, before retraction of the infusion needle. This is achieved with the embodiments described next (clutch; cam drive).
  • Another mechanism to ensure that the needle arm and the stylet arm are at some times rotated together and at other times rotated individually may involve a drive unit with at least one biasing element and a clutch, as described hereinafter.
  • the at least one biasing element may provide a biasing force which urges the stylet arm jointly with the needle arm about the common axis of rotation either in the advancing direction or in the retraction direction
  • the clutch may be configured for selectively connecting the drive unit with at least one of: the stylet arm, the needle arm, and both the stylet arm and needle arm. This way, both the needle arm and the stylet arm are always urged in the same direction by means of the biasing element, i.e. toward their retracted positions or toward their advanced positions.
  • the drive unit may support such movement (rotation) if this is needed or at least helpful to overcome certain counteracting forces, such as when the tip end of the infusion needle pierces the penetration area.
  • the drive unit may rotate the two arms in the opposite direction.
  • the drive unit engages either the stylet arm (or the needle arm) or both the stylet arm and the needle arm and, therefore, moves one or both of the two arms in the opposite direction against the biasing force.
  • the at least one biasing element provides a biasing force which urges the stylet arm jointly with the needle arm about the common axis of rotation in the advancing direction.
  • the clutch may be configured for selectively connecting the drive unit either with the stylet arm, for retracting the stylet inside the infusion needle towards its retracted position by rotating the stylet arm about the common axis of rotation in the retraction direction, or with either the needle arm or both needle arm and the stylet arm, for retracting the infusion needle by rotating the needle arm about the common axis of rotation in the retraction direction.
  • the at least one biasing element may comprise a torque spring.
  • biasing elements are also possible, such springs of other type or biasing elements providing magnetic and/or electro- magnetic forces, to name only a few.
  • torque springs are preferred for their simplicity.
  • the torque spring has a square or rectangular cross-section so as to provide maximum force on a minimum of space.
  • one biasing element may be provided for each of the needle arm and stylet arm.
  • a single biasing element acting on the stylet arm might be sufficient.
  • a separate biasing element may be provided to urge the needle arm toward its advanced position, namely in order to securely hold the needle arm in the advanced position at the time when the stylet arm retracts the stylet backwards inside the hollow body of the infusion needle.
  • the infusion needle can be retracted back into the housing after the stylet has been re-inserted into the needle body, by rotating the stylet arm about the common axis of rotation in the advancing direction, before retraction of the infusion needle.
  • An even further mechanism to ensure that the needle arm and the stylet arm are at some times rotated together and at other times rotated individually may involve a drive unit with a needle crank arm and a stylet crank arm, as described hereinafter.
  • the needle crank arm may be connected with one end thereof to the needle arm and with another end thereof to a needle guide pathway such that movement of the needle crank arm along the needle guide pathway and rotation of the needle arm about the common axis of rotation are interdependent
  • the stylet crank arm may be connected with one end thereof to the stylet arm and with another end thereof to a stylet guide pathway such that movement of the stylet crank arm along the stylet guide pathway and rotation of the stylet arm about the common axis of rotation are interdependent.
  • the drive unit may further include at least one cam which comprises a needle cam pathway and a stylet cam pathway. Then, the needle crank arm may be connected, e.g.
  • the stylet crank arm may be connected, e.g. by a second cam follower, to the stylet cam pathway in such a way that rotation of the cam causes the stylet arm to rotate about the common axis of rotation.
  • the needle cam pathway and the stylet cam pathways may be in the form of a groove or a ridge along which the cam followers are forced to move.
  • the at least one cam is in the form of a cam disk which is rotatable about a central axis.
  • the needle arm and the stylet arm, respectively may be urged to rotate about the common axis of rotation by simply rotating the at least one cam disk. That is, because the needle and stylet crank arms engage the needle and stylet cam pathways and are forced to move along these cam pathways, respectively, in particular by means of their cam followers, rotation of the cam disk or disks causes movement of the crank arms and, consequently, movement (rotation) of the needle arm and stylet arm, respectively, to which the crank arms are connected.
  • a single cam disk is provided exhibiting both the needle cam pathway and the stylet cam pathway, so that only one cam needs to be driven in order to move advance and retract the infusion needle and its stylet, respectively.
  • the needle arm and stylet arm are mounted on a carriage which is movable inside the housing or casing so as to laterally move the tip end of the at least one infusion needle between different lateral positions.
  • the carriage may be rotatably mounted inside the housing or casing, i.e. such lateral movement of the tip end of the infusion needle is in fact a movement about the common axis of rotation.
  • a further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed implantable drug delivery system and which is configured to be held in position by a tissue portion of a patient, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first,
  • the second portion has a first end and a second end opposing the first end along the first direction, wherein the second portion has a length between the first and second end, and wherein the second portion has an intermediate region and a distal region, wherein the intermediate region is defined by the connecting interface between the connecting portion and the second portion, and the distal region extends from the connecting interface between the connecting portion and the second portion to the second end.
  • the lengthwise cross-sectional area of the second portion decreases continuously from an end of the intermediate region towards the second end.
  • the lengthwise cross-sectional area of the second portion decreases linearly from an end of the intermediate region towards the second end.
  • the lengthwise cross-sectional area of the second portion decreases stepwise from an end of the intermediate region towards the second end.
  • the distal region of the second portion is conically shaped.
  • the second portion has rotational symmetry along the first direction.
  • the second surface of the second portion is substantially perpendicular to a central extension of the connecting portion.
  • the second surface of the second portion is substantially parallel to the second plane. [0277] In some embodiments, the second surface of the second portion is substantially flat and configured to form a contact area to the second tissue surface, and wherein the second portion further comprises a lower surface facing away from the first portion configured to taper towards the second end.
  • the second portion has a proximal region, wherein the proximal region extends from the first end to the connecting interface between the connecting portion and the second portion.
  • the lengthwise cross-sectional area of the second portion decreases continuously from an end of the intermediate region towards the first end.
  • the lengthwise cross-sectional area of the second portion decreases linearly from an end of the intermediate region towards the first end.
  • the lengthwise cross-sectional area of the second portion decreases stepwise from an end of the intermediate region towards the first end.
  • the proximal region of the second portion is conically shaped.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end.
  • the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the second portion has said length in a direction being different to a central extension of the connecting portion.
  • the connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • the connecting interface between the connecting portion and the second portion is eccentric, with respect to the second portion, in the first direction, but not in a second direction being perpendicular to the first direction.
  • the connecting interface between the connecting portion and the second portion is eccentric, with respect to the second portion, in the first direction and in a second direction being perpendicular to the first direction.
  • the second direction is parallel to the second plane.
  • the proximal region and the distal region comprises the second surface configured to engage the second surface of the second side of the tissue portion.
  • the second portion is tapered from the first end to the second end.
  • the second portion is tapered from the intermediate region of the second portion to each of the first end and second end.
  • the first portion has a maximum dimension being in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, such as in the range of 15 to 25 mm.
  • the first portion has a diameter being in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, such as in the range of 15 to 25 mm.
  • the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, such as in the range of 5 to 10 mm.
  • the second portion has a maximum dimension being in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, such as in the range of 35 to 60 mm.
  • the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flat disk shape.
  • the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section, in a plane parallel to the third plane.
  • the distal region is configured to be directed downwards in a standing patient.
  • the first portion has a first height
  • the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, wherein the first height is smaller than the second height.
  • the first height is less than 2/3 of the second height, such as less than 1/2 of the second height, such as less than 1/3 of the second height.
  • the second end of the second portion comprises connections for connecting to an implant being located in a caudal direction from a location of the implantable energized medical device in the patient.
  • the first end of the second portion comprises connections for connecting to an implant being located in a cranial direction from a location of the implantable energized medical device in the patient.
  • the connecting portion further comprises a fourth cross-sectional area in a fourth plane, wherein the fourth plane is parallel to the first, second and third planes, and wherein the third cross-sectional area is smaller than the fourth cross-sectional area.
  • the connecting portion comprises a protruding element comprising the fourth cross-sectional area.
  • the first surface is configured to engage the first tissue surface of the first side of the tissue portion.
  • the first portion comprises a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter.
  • the first portion comprises an internal wireless energy transmitter.
  • the second portion comprises a second wireless energy receiver.
  • the first portion comprises a first energy storage unit.
  • the second portion comprises a second energy storage unit.
  • At least one of the first and second energy storage unit is a solid- state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter, and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the second portion comprises at least a portion of an operation device for operating an implantable body engaging portion.
  • the second portion comprises at least one electrical motor.
  • the second portion comprises a transmission configured to reduce the velocity and increase the force of the movement generated by the electrical motor.
  • the transmission is configured to transfer a week force with a high velocity into a stronger force with lower velocity.
  • the transmission is configured to transfer a rotating force into a linear force.
  • the transmission comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electrical motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the second portion comprises at least one hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage unit and connected to the electrical motor, wherein the capacitor is configured to: be charged by at least one of the first and second energy storage units, and provide the electrical motor with electrical power.
  • at least one of the first and second portion comprises a sensation generator adapted to generate a sensation detectable by a sense of the patient.
  • the second portion comprises a force transferring element configured to mechanically transfer force from the second portion to an implanted body engaging portion.
  • the second portion comprises a force transferring element configured to hydraulically transfer force from the second portion to an implanted body engaging portion.
  • the second portion comprises at least one lead for transferring electrical energy and/or information from the second portion to an implanted body engaging portion.
  • the first portion comprises an injection port for injecting fluid into the first portion.
  • the connecting portion comprises a conduit for transferring a fluid from the first portion to the second portion.
  • the conduit is arranged to extend through the hollow portion of the connecting portion.
  • the second portion comprises a first and a second chamber separated from each other, wherein the first chamber comprises a first liquid and the second chamber comprises a second liquid, and wherein the second liquid is a hydraulic liquid configured to transfer force to an implantable element configured to exert force on the body portion of the patient.
  • a wall portion of the first chamber is resilient to allow an expansion of the first chamber.
  • the second portion comprises a first hydraulic system in fluid connection with a first hydraulically operable implantable element configured to exert force on the body portion of the patient, and a second hydraulic system in fluid connection with a second hydraulically operable implantable element configured to exert force on the body portion of the patient, wherein the first and second hydraulically operable implantable elements are adjustable independently from each other.
  • the first hydraulic system comprises a first hydraulic pump, which first hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump
  • the second hydraulic systems comprises a second hydraulic pump, which second hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • each of the first and second hydraulic systems comprises a reservoir for holding hydraulic fluid.
  • the implantable energized medical device further comprises a first pressure sensor configured to sense a pressure in the first hydraulic system, and a second pressure sensor configured to sense a pressure in the second hydraulic system.
  • the first surface is configured to engage the first tissue surface of the first side of the tissue portion.
  • the first, second and third planes are parallel to a major extension plane of the tissue.
  • the fourth plane is parallel to a major extension plane of the tissue.
  • a further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed implantable drug delivery system and which is configured to be held in position by a tissue portion of a patient, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue
  • the first portion is configured to transmit electromagnetic waves at the frequency above the frequency level to an external device.
  • the frequency level is 40 kHz or 20 kHz.
  • the electromagnetic waves comprise wireless energy and/or wireless communication.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter above the frequency level, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion below the frequency level
  • the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter below the frequency level.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device above the frequency level, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion below the frequency level.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion below the frequency level.
  • the first portion comprises an outer casing made from a polymer material.
  • the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.
  • the second portion comprises an outer casing made from titanium.
  • the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the second portion must travel through the casing.
  • a further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed implantable drug delivery system and which is configured to be held in position by a tissue portion of a patient, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue
  • the second portion is configured to receive and/or transmit electromagnetic waves at a frequency below the frequency level.
  • the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to the second portion.
  • the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to an external device.
  • the frequency level is 40 kHz or 20 kHz.
  • the electromagnetic waves comprise wireless energy and/or wireless communication.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter below the frequency level, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion below the frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter below the frequency level.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device below the frequency level, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion below the frequency level.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion below the frequency level.
  • the first portion comprises an outer casing made from a polymer material.
  • the first portion comprises an outer casing made from titanium.
  • the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.
  • the second portion comprises an outer casing made from titanium.
  • the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the second portion must travel through the casing.
  • a further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed implantable drug delivery system and which is configured to be held in position by a tissue portion of a patient, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue
  • the casing of the second portion forms a complete enclosure such that the entirety of the outer surface of the second portion is covered by the casing, when the second portion is connected to the connecting portion.
  • the first portion comprises a casing made from the polymer material.
  • the casing of the first portion forms a complete enclosure such that the entirety of the outer surface of the first portion is covered by the casing.
  • the connecting portion comprises a connection arranged to connect to the first and second portion respectively and carry electrical signals and/or energy.
  • connection is arranged in a core of the connecting portion such that it is encapsulated by outer material of the connecting portion.
  • the connecting portion comprises a ceramic material.
  • connection is encapsulated within the ceramic material.
  • the first portion comprises a first connection configured to connect to the connection of the connecting portion.
  • the second portion comprises a second connection configured to connect to the connection of the connection portion.
  • the casing of the second portion is hermetically sealed.
  • the second connection is arranged such that the hermetical seal of the second portion is kept intact.
  • the casing of the first portion is hermetically sealed.
  • a further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed implantable drug delivery system and which is configured to be held in position by a tissue portion of a patient, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a third surface configured to engage the first tissue surface of the first side of the tissue
  • the third cross-sectional area is smaller than the first cross-sectional area.
  • the connecting portion is tapered in the direction from the first portion towards the second portion along the central extension axis.
  • the connecting portion has a circular or oval cross-section along the central extension axis with a decreasing diameter in the direction from the first portion towards the second portion.
  • the second portion is tapered in the length direction.
  • the connecting portion has a circular or oval cross-section in the length direction with a decreasing diameter in the length direction.
  • the length direction extends from an interface between the connecting portion and the second portion towards an end of the second portion.
  • the length direction extends in a direction substantially perpendicular to the central extension axis.
  • a further aspect of the present disclosure relates to an implantable energized medical device, which may advantageously be combined with the disclosed implantable drug delivery system, configured to be held in position by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, and a hermetic seal
  • the flexible structure is configured to allow the connecting portion to flex in more than one direction.
  • the flexible structure is configured to allow the connecting portion to flex in all directions.
  • the flexible structure comprises a bellows.
  • the bellows is a metallic bellows.
  • the metallic bellows is welded.
  • the bellows is a titanium bellows.
  • the bellows form part of the hermetic seal arrangement.
  • the flexible structure comprises elevated and lowered portions enabling said flexing of the connecting portion.
  • the elevated and lowered portions are configured to enable the connecting portion to be compressed and/or expanded.
  • the flexible structure has a substantially cylindrical shape.
  • the flexible structure is configured to seal against the first portion and/or the second portion.
  • the connecting portion and the second portion are hermetically sealed from the first portion.
  • the hermetic seal arrangement encloses the connecting portion and the second portion so as to hermetically seal the connecting portion and the second portion from the first portion.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.
  • the first portion comprises a first energy storage unit connected to the first wireless energy receiver.
  • the second portion comprises a second energy storage unit connected to the second wireless energy receiver.
  • at least one of the first and second energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device,
  • the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end.
  • the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end.
  • the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the implantable energized medical device further comprises a gear arrangement and an electric motor, wherein the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the second portion comprises at least one hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • an implantable energized medical device configured to be held in position by a tissue portion of a patient
  • the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-section
  • said physical footprint comprises a cross-sectional area perpendicular to the central axis.
  • the connecting portion and the second portion are one of: configured to reversibly connect to each other to form said unit; or configured to irreversibly connect to each other to form said unit; or configured as a single body forming said unit.
  • said unit comprises an angled section forming a bend in said unit.
  • the bend is between 15° and 165°, such as between 30° and 150°, such as between 45° and 135°, such as substantially 90°.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.
  • the first portion comprises a first energy storage unit connected to the first wireless energy receiver.
  • the second portion comprises a second energy storage unit connected to the second wireless energy receiver.
  • At least one of the first and second energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end.
  • the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end. [0491] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the implantable energized medical device further comprises a gear arrangement and an electric motor, wherein the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the second portion comprises at least one hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • an implantable energized medical device configured to be held in position by a tissue portion of a patient
  • the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-section
  • an implantable energized medical device configured to be held in position by a tissue portion of a patient
  • the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, and an electric motor, wherein: the first, second, and third planes are parallel to each other, the
  • the electric motor is arranged within the connecting portion within an imaginary boundary defined by the first surface of the first portion extending through the connecting portion.
  • the electric motor is arranged within the connecting portion within an imaginary boundary defined by the second surface of the second portion extending through the connecting portion. [0503] In some embodiments, the electric motor is fully arranged in the connecting portion within imaginary boundaries defined by the first surface of the first portion extending through the connecting portion and the second surface of the second portion extending through the connecting portion respectively.
  • the electric motor is arranged such that its longest dimension extends in a direction substantially perpendicular to the first, second and third cross-sectional areas.
  • the electric motor is arranged such that its longest dimension extends in a direction between the first portion and the second portion.
  • the worm drive is configured to transfer mechanical force from the electric motor to an implantable body engaging portion being external to the implantable energized medical device.
  • the electric motor extends through the connecting portion into the first portion and/or the second portion.
  • the electric motor extends through an imaginary boundary defined by the first surface of the first portion extending through the connecting portion.
  • the electric motor extends through an imaginary boundary defined by the second surface of the second portion extending through the connecting portion.
  • the electric motor extends through imaginary boundaries defined by the first surface of the first portion extending through the connecting portion and the second surface of the second portion extending through the connecting portion respectively.
  • the implantable energized medical device further comprises a gear arrangement operatively connected to the electric motor wherein the gear arrangement is partly or fully arranged in one of the first portion and the second portion.
  • the gear arrangement is arranged within the connecting portion within an imaginary boundary defined by the first surface of the first portion extending through the connecting portion.
  • the gear arrangement is arranged within the connecting portion within an imaginary boundary defined by the second surface of the second portion extending through the connecting portion. [0514] In some embodiments, the gear arrangement is fully arranged in the connecting portion within imaginary boundaries defined by the first surface of the first portion extending through the connecting portion and the second surface of the second portion extending through the connecting portion respectively.
  • the gear arrangement extends through the connecting portion into the first portion and/or the second portion.
  • the gear arrangement extends through an imaginary boundary defined by the first surface of the first portion extending through the connecting portion.
  • the gear arrangement extends through an imaginary boundary defined by the second surface of the second portion extending through the connecting portion.
  • the gear arrangement extends through imaginary boundaries defined by the first surface of the first portion extending through the connecting portion and the second surface of the second portion extending through the connecting portion respectively.
  • the gear arrangement is configured to transfer mechanical force from the electric motor to an implantable body engaging portion being external to the implantable energized medical device.
  • the gear arrangement is a worm drive or comprises a worm drive.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.
  • the first portion comprises a first energy storage unit connected to the first wireless energy receiver.
  • the second portion comprises a second energy storage unit connected to the second wireless energy receiver.
  • At least one of the first and second energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end.
  • the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end.
  • the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the second portion comprises at least one hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • an implantable energized medical device configured to be held in position by a tissue portion of a patient
  • the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, the first portion being further configured to connect, directly or indirectly, to a second portion placed on a second side of the tissue portion opposing the first side, wherein the first portion comprises an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion.
  • the first portion is configured to connect, directly or indirectly, to the second portion, via a connecting portion configured to extend through a hole in the tissue portion, the hole extending between the first side of the tissue portion and the second side of the tissue portion.
  • the implantable energized medical device further comprises the connecting portion.
  • the connecting portion is integrally formed with the first portion.
  • the connecting portion is a separate component with regard to the first portion, the connecting portion being configured to be connected to the first portion.
  • the first portion has a first cross-sectional area in a first plane and the connecting portion has a second cross-sectional area in a second plane, wherein the first and second planes are parallel to each other, wherein the second cross-sectional area is smaller than the first cross- sectional area, such that the first portion and the second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first and second planes.
  • the first portion is configured to detachably connect, directly or indirectly, to the second portion.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter.
  • the first portion comprises a first energy storage unit connected to the first wireless energy receiver.
  • the first energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to a second wireless energy receiver in the second portion.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the first controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the connecting portion comprises a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, and - an implantable energy storage unit arranged in the first portion, the connecting portion or
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, and - an implantable electric motor arranged in the first portion, the connecting portion or the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, and - an implantable reservoir configured to hold a fluid, the implantable reservoir being
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, and - an implantable pump, which may include a piezoelectric motor or may
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable energy storage unit arranged in the first portion, the connecting portion or the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable reservoir configured to hold a fluid arranged in the first portion, the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable reservoir configured to hold a fluid, the implantable reservoir being arranged
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable pump, which may include a piezoelectric motor or may be
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, and - an implantable electric motor arranged in the first portion, the connecting portion or the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable energy storage unit arranged in the first portion, the connecting portion or the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable reservoir configured to hold a fluid arranged in the first portion, the
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable reservoir configured to hold a fluid, the implantable reservoir being arranged
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, - an implantable pump, which may include a piezoelectric motor or may be
  • a system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, - a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, - a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross- sectional area in a third plane and being configured to connect the first portion to the second portion, and - an implantable energy storage unit arranged in the first portion, the connecting portion or
  • the implantable energized medical device further comprises a first wireless communication receiver configured to receive communication signals from outside the patient’s body.
  • the implantable energized medical device further comprises a second wireless communication transmitter arranged in the second portion, wherein the second wireless communication transmitter is configured to transmit communication signals to the first wireless communication receiver.
  • the implantable energized medical device further comprises a first wireless communication transmitter arranged in the first portion, the first wireless communication transmitter being configured to transmit communication signals outside of the patient’s body.
  • the implantable energized medical device further comprises a second wireless communication receiver arranged in the second portion, wherein the first wireless communication transmitter is configured to transmit communication signals to the second wireless communication receiver.
  • the implantable energized medical device further comprises a wireless energy receiver configured to receive energy transmitted wirelessly from outside the patient’s body and deliver the received energy to the implantable energy storage unit.
  • the implantable energized medical device further comprises a control unit configured to control at least one of the body engaging implant, the implantable energy storage unit, the implantable pump, and the implantable electric motor.
  • the implantable electric motor is operatively connected to the implantable pump via a rotatable shaft.
  • the implantable electric motor is operatively connected to the implantable pump via a magnetic coupling.
  • the system further comprises a gear arrangement arranged in the implantable energized medical device and operatively connected to the electric motor, the gear arrangement being configured to reduce the velocity and increase the force of movement generated by the electric motor.
  • the system further comprises a gear arrangement arranged externally to the implantable energized medical device and operatively connected to the electric motor, the gear arrangement being configured to reduce the velocity and increase the force of movement generated by the electric motor.
  • the system further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the system further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end.
  • the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end.
  • the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the system further comprises a gear arrangement, wherein the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the pump is a hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • an implantable energized medical device configured to be held in position by a tissue portion of a patient
  • the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-section
  • a height of the first portion measured in a plane perpendicular to the first plane is 15 mm or less, such as 10 mm or less, such as 7 mm or less, such as 5 mm or less.
  • the connecting interface arrangement comprises a port for transferring fluid from the first portion to said additional implant.
  • the implantable energized medical device further comprises at least one conduit or tube for transferring said fluid, wherein the at least one conduit or tube is connected to the port.
  • the implantable energized medical device further comprises at least one wire for energy and/or communication signals connected to the connecting interface arrangement.
  • the height of the first portion is a maximum height.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.
  • the first portion comprises a first energy storage unit connected to the first wireless energy receiver.
  • the second portion comprises a second energy storage unit connected to the second wireless energy receiver.
  • At least one of the first and second energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end.
  • the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end. [0659] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the implantable energized medical further comprises a gear arrangement and an electric motor, wherein the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the second portion comprises at least one hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • an implantable energized medical device configured to be held in position by a tissue portion of a patient
  • the medical device comprising: a first portion configured to be placed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion, a second portion configured to be placed on a second side of the tissue portion, the second side opposing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion, and a connecting portion configured to be placed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and being configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-section
  • a height of the second portion measured in a plane perpendicular to the second plane is 15 mm or less, such as 10 mm or less, such as 7 mm or less, such as 5 mm or less.
  • the first portion has a length in a plane parallel to the first plane, wherein the second portion has a length in a plane parallel to the second plane, and wherein the length of the first portion differ no more than 30% with regard to the length of the second portion, such as wherein the length of the first portion differ no more than 15% with regard to the length of the second portion, such as wherein the length of the first portion differ no more than 5% with regard to the length of the second portion, such as wherein the length of the first portion differ no more than 1% with regard to the length of the second portion.
  • the first portion has a width in a plane parallel to the first plane, wherein the second portion has a width in a plane parallel to the second plane, and wherein the width of the first portion differ no more than 30% with regard to the width of the second portion, such as wherein the width of the first portion differ no more than 15% with regard to the width of the second portion, such as wherein the width of the first portion differ no more than 5% with regard to the width of the second portion, such as wherein the width of the first portion differ no more than 1% with regard to the width of the second portion.
  • the first portion has a height in a plane perpendicular to the first plane, and wherein the height of the first portion differ no more than 30% with regard to the height of the second portion, such as wherein the height of the first portion differ no more than 15% with regard to the height of the second portion, such as wherein the height of the first portion differ no more than 5% with regard to the height of the second portion, such as wherein the height of the first portion differ no more than 1% with regard to the height of the second portion.
  • a height of the first portion measured in a plane perpendicular to the first plane is 15 mm or less, such as 10 mm or less, such as 7 mm or less, such as 5 mm or less.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.
  • the first portion comprises a first energy storage unit connected to the first wireless energy receiver.
  • the second portion comprises a second energy storage unit connected to the second wireless energy receiver.
  • At least one of the first and second energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end. [0696] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end.
  • the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the implantable energized medical device further comprises a gear arrangement and an electric motor, wherein the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • the second portion comprises at least one hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.
  • the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.
  • the actuator comprises an electric motor.
  • the actuator is arranged in the connecting portion.
  • the actuator is partly or fully arranged inside the sealed container.
  • the second portion comprises a port in fluid communication with the reservoir for transferring fluid between the reservoir and an additional implant in the patient.
  • the implantable energized medical device further comprises a conduit connected to the port, the conduit being configured to transfer fluid between the reservoir and the additional implant.
  • the implantable energized medical device further comprises an injection port for introducing fluid, the injection port being arranged in the first portion.
  • the implantable energized medical device further comprises an internal conduit connecting the injection port to the reservoir.
  • the sealed container is a bellows.
  • the bellows is a metallic bellows.
  • At least a portion of the sealed container configured to be in contact with fluid comprises metal.
  • the volume of the sealed container can be altered such that the volume of the sealed container is more than 60% of the maximum volume of the reservoir.
  • the sealed container comprises at least one flexible portion, and wherein the flexible portion enable at least one of compression and expansion of the sealed container.
  • the sealed container comprises at least one elastic portion, and wherein the elastic portion enable at least one of compression and expansion of the sealed container.
  • the implantable energized medical device further comprises a first energy storage unit and/or a second energy storage unit for powering the actuator.
  • the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter configured to transmit energy wirelessly to the second portion, and the second portion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.
  • the first energy storage unit is connected to the first wireless energy receiver.
  • the second portion comprises the second energy storage unit, wherein the second energy storage unit is connected to the second wireless energy receiver.
  • At least one of the first and second energy storage unit is a solid-state battery.
  • the solid-state battery is a thionyl -chloride battery.
  • the first wireless energy receiver is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit
  • the internal wireless energy transmitter is configured to wirelessly transmit energy stored in the first energy storage unit to the second wireless energy receiver
  • the second wireless energy receiver is configured to receive energy transmitted wirelessly by the internal wireless energy transmitter and store the received energy in the second energy storage unit.
  • the first portion comprises a first controller comprising at least one processing unit.
  • the second portion comprises a second controller comprising at least one processing unit.
  • the first controller and/or the second controller is configured to control the actuator.
  • At least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.
  • the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.
  • the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.
  • the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.
  • the first portion comprises a combined coil, wherein the combined coil is configured to receive energy wirelessly from an external wireless energy transmitter, and transmit energy wirelessly to the second wireless receiver of the second portion.
  • At least one of the coils are embedded in a ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the first portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the implantable energized medical device further comprises a housing configured to enclose at least the second portion, and wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.
  • the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.
  • the first portion is detachably connected to at least one of the second portion and the connecting portion.
  • the connecting portion comprising a flange having a flange area being larger than a cross-section area of the hole in the tissue portion, such that the flange is hindered from travelling through the hole in the tissue portion, such that the second portion and the connecting portion can be held in position by the tissue portion of the patient also when the first portion is disconnected from the connecting portion.
  • a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.
  • a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.
  • the second portion has a first end and a second end opposing the first end, wherein the second portion has a length between the first and second end.
  • the first end and second end are separated in a direction parallel to the second plane.
  • the first and second ends comprise an elliptical point respectively.
  • the first and second ends comprise a hemispherical end cap respectively.
  • the second portion has at least one circular cross-section along the length between the first and second end.
  • the second portion has at least one oval cross-section along the length between the first and second end.
  • the second portion has at least one elliptical cross-section along the length between the first and second end.
  • the implantable energized medical device further comprises a gear arrangement, wherein the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.
  • the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.
  • the gear arrangement is configured to transfer a rotating force into a linear force.
  • the gear arrangement comprises a gear system.
  • the second portion comprises a magnetic coupling for transferring mechanical work from the electric motor through one of: a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing enclosing at least the second portion.
  • Fig. 1 shows the overall system of the present disclosure implanted in a patient’s body according to a first variation
  • Fig. 2 shows the overall system of the present disclosure implanted in a patient’s body according to a second variation
  • Fig. 3 shows a first general concept how a penetration area can be penetrated by an infusion needle at different penetration sites
  • Fig. 4 shows a second general concept how a penetration area can be penetrated by an infusion needle at different penetration sites
  • Figs. 5 and 6 show a front view and a rear view, respectively, of a drive unit according to a first embodiment
  • Fig. 7 shows a needle cooperating member of the drive unit according to the first embodiment to which an infusion needle is mounted
  • Fig. 8 shows a perspective view of the needle cooperating member of Fig. 7 and a base
  • Figs. 9 and 10 show a front view and a rear view, respectively, of a drive unit according to a second embodiment
  • Figs. 11 and 12 show a front view and a rear view, respectively, of a drive unit according to a third embodiment
  • Fig. 13 shows a needle cooperating member of the drive unit according to the third embodiment comprising two separable parts
  • Fig. 14 shows an alignment structure of the drive unit according to the third embodiment
  • Fig. 15 illustrates the injection of a substance into a vein using the drive unit according to the third embodiment
  • Figs.l6A, 16B, 16B’ and 16C generally illustrate a system for communicating with an implanted medical device
  • Fig. 17 shows an embodiment of a system for charging, programming and communicating with a controller of an implanted medical device
  • Fig. 18 shows an elevated perspective view from the left of a housing unit
  • Fig. 19 shows a plan view from the left of a housing unit:
  • Fig. 20 shows an elevated perspective view from the left of a housing unit
  • Fig. 21 shows a plan view from the left of a housing unit
  • Fig. 22 shows a system overview of an external device comprising a housing unit and a display device in wireless communication with an implanted medical device;
  • Fig. 21 shows an implant with an implant surface and a coating arranged on the surface
  • Fig. 24 shows an implant with an implant surface and multiple coatings arranged on the surface
  • Figs. 25A and 25B show different micro patterns on the surface of an implant
  • Fig. 26 shows a flow chart of a method of implantation of the system
  • Figs. 27 and 28 show an embodiment of an implantable energized medical device
  • Figs. 29A to 29D show a first portion and a connecting portion of the medical device of Figs. 27 and 28;
  • Figs. 30A to 32B show variants of an element of the connecting portion of Figs. 29A to 29C;
  • Fig. 33 shows a kit for assembling the medical device of Figs. 27 and 28;
  • Fig. 34 shows a further embodiment of an implantable energized medical device
  • Fig. 35 shows a general example of an implantable energized medical device
  • Fig. 36 shows a first variant of the general example of the medical device of Fig. 35;
  • Fig. 37 shows a second variant of the general example of the medical device of Fig. 35;
  • Figs. 38A and 38B show cross sections of the medical device of Fig. 35;
  • Figs. 39A to 39Q show different relative arrangements of first and second parts of the medical device of Fig. 35;
  • Figs. 40 and 41 show a third variant of the general example of the medical device of Fig. 35;
  • Figs. 42 and 43 show the medical device of Fig. 35 with first and second parts thereof being differently rotationally displaced relative to each other;
  • Figs. 44A to 44C illustrate a procedure of inserting the medical device of Figs. 40 and 41;
  • Fig. 45 shows an even further embodiment of an implantable energized medical device
  • Figs. 46A and 46B illustrate a gear arrangement and magnetic coupling for coupling the implantable energized medical device to an implant
  • Fig. 47A shows a perspective elevated view from the right of an embodiment of an implantable energized medical device for powering an implantable medical device
  • Figs. 47B and 47C show lengthwise cross-sectional areas of the implantable medical device along the line A-A in Fig. 47A;
  • Figs. 48 to 50 show cross-sectional plain side views of embodiments of an implantable energized medical device for powering an implantable medical device
  • Fig. 51A shows a perspective elevated view from the right of an embodiment of an implantable energized medical device for powering an implantable medical device
  • Figs. 5 IB and 51C show lengthwise cross-sectional areas of the implantable medical device along the line A-A in Fig. 51A;
  • Fig. 52 shows a cross-sectional plain side view of an embodiment of an implantable energized medical device;
  • Figs. 53A - 53C show cross-sectional plain side views of an embodiment of an implantable energized medical device
  • Figs. 54A - 54D show cross-sectional plain side views of the embodiment in Figs. 53A - 53C when inserted into a tissue portion;
  • Figs. 55A - 55F show cross-sectional plain side views of embodiments of an implantable energized medical device
  • Fig. 56 shows an embodiment of an implantable energized medical device for powering an implantable medical device or body engaging portion
  • Figs. 57A - 57N and 57P - 57Q show schematic cross-sectional plain side views of systems comprising an implantable energized medical device
  • Fig. 58A - 58B show cross-sectional plain side views of embodiments of an implantable energized medical device
  • Fig. 59A - 59B show cross-sectional plain side views of embodiments of an implantable energized medical device
  • Fig. 60A illustrates schematically a variant of the overall system according to the first general aspect of Fig. 3 comprising an inclined infusion needle;
  • Fig. 60B illustrates the variant of Fig. 60A with a curved surface of the housing
  • Fig. 60C illustrates the variant of Fig. 60A with a plurality of infusion needles
  • Fig. 60D illustrates the variant of Fig. 60A with a curved needle
  • Fig. 60E illustrates the variant of Fig. 60A with a curved surface of the housing and a curved needle
  • Fig. 61 illustrates the principle of injecting a substance using an inclined infusion needle
  • Figs. 62A and 62B show a front portion of an infusion needle in atop view and a cross-sectional side view, respectively, with an injection port arranged close to the tip end of the infusion needle;
  • Fig. 63 illustrates schematically the penetration area of the system with infusion needles being arranged in respective tubes
  • Fig. 64 illustrates schematically the penetration area of the system with pre -configured passages having a widened entrance section for the infusion needle to enter;
  • Fig. 65 illustrates schematically the penetration area of the system with pre -configured passages into which the infusion needles extend with their respective tip ends;
  • Fig. 66 illustrates schematically the penetration area of the system with pre -configured passages having a widthwise extension and a compressor for opening these passages;
  • Fig. 67 illustrates the principle of injecting a substance using an infusion needle which comprises a retractable stylet (although the infusion needle is shown as being inclined, it does not need to be inclined according to this principle);
  • Fig. 68 illustrates the principle as shown in Fig. 67, wherein the stylet extends from the infusion needle;
  • Fig. 69 illustrates the principle as shown in Fig. 67, wherein the infusion needle with stylet extends from a laterally displaceable penetration area;
  • Fig. 70 illustrates the variant of Fig. 60E with a curved infusion needle and a stylet
  • Fig. 71A to 7 ID illustrate a first principle of a mechanism for rotating a needle arm and a stylet arm, here involving a biasing element and releasable holder;
  • Fig. 72 illustrates the mechanism of Figs. 71A to 7 ID implemented in an overall system according to a first embodiment of the first principle
  • Figs. 73A and 73B illustrate the mechanism of Figs. 71A to 71D implemented in an overall system according to a second embodiment of the first principle
  • Figs. 74A to 74D illustrate a second principle of a mechanism for rotating a needle arm and a stylet arm, here involving at least one biasing element and a clutch;
  • Figs. 75A to 75C illustrate a clutch for the mechanism according to the second principle
  • Fig. 76 illustrates the mechanism of Figs. 74A to 74D implemented in an overall system according to the second principle
  • Fig. 77 illustrates a third principle of a mechanism for rotating a needle arm and a stylet arm, here involving a needle crank arm and a stylet crank arm;
  • Fig. 78 illustrates the mechanism according to the third principle further involving a cam drive;
  • Figs. 79A to 79C illustrate different stages of the mechanism according to the third principle involving a needle crank arm, a stylet crank arm and a cam drive;
  • Fig. 79D illustrates an angle between the infusion needle and a blood vessel
  • Fig. 80 illustrates the mechanism of Figs. 79A to 79C implemented in an overall system according to the third principle
  • Fig. 81 shows, schematically, an embodiment of an inchworm motor
  • Fig. 82 illustrates, schematically, an operation cycle of a piezoelectric inchworm motor
  • Fig. 83 shows, schematically, an embodiment of a piezoelectric inertial motor
  • Fig. 84 shows, schematically, an embodiment of a piezoelectric walk-drive motor
  • Fig. 85 illustrates, schematically, an operation cycle of a piezoelectric walk-drive motor
  • Fig. 86 shows, schematically, a Traveling Wave Ultrasonic Motor (TWUSM);
  • Fig. 87 shows, schematically, an embodiment of a Standing Wave Ultrasonic Motor (SWUSM);
  • SWUSM Standing Wave Ultrasonic Motor
  • Fig. 88 shows, schematically, an embodiment of a linear ultrasonic motor
  • Figs. 89A to 89C show, schematically, an embodiment of a piezoelectric pump
  • Figs. 90A to 90B show, schematically, an embodiment of a ball valve
  • Figs. 91A to 91B show, schematically, an embodiment of a piezoelectric pump wherein the inlet and outlet comprise static elements acting as nozzles or diffusers;
  • Fig. 92 shows, schematically, an embodiment of a piezoelectric pump configured to operate in a double mode
  • Fig. 93 shows, schematically, an embodiment of a piezoelectric pump comprising at least two portions connected in series;
  • Fig. 94 shows, schematically, an embodiment of a piezoelectric pump comprising at least two portions connected in parallel;
  • Fig. 95 shows, schematically, an embodiment of a piezoelectric pumping system. Detailed description
  • Fig. 1 shows a first variation of an overall system.
  • the overall structure corresponds to the structure as disclosed in Fig. 1 ofWO 2010/040548 Al.
  • a housing 12 with a single infusion needle 11 and a drive unit D.
  • the drive unit D schematically indicates by arrows that it is able to move the needle or needles 11 in different directions.
  • the housing 12 is implanted with a self-sealing penetration area 14 positioned adjacent a patient’s vessel 7 which is in the form of a corpus cavemosum here, but which may be any other kind of vessel, in particular a blood vessel, such as a vein or an artery.
  • the infusion needle or needles may have a tube-like body closed at the tip end and provided with a laterally arranged delivery exit port for delivery of the drug. Therefore, the needle will not cut out any material but will simply divide it during penetration. Thus, when the needle penetrates any material, such as fibrosis and/or the self-sealing penetration area 14 arranged in the housing’s wall, there will be no material entering and blocking the drug delivery passageway.
  • a motor M in particular a piezoelectric motor, is contained in the housing 12 for driving a part of the drive unit D.
  • the motor M within the housing 12 is controlled by means of a control unit C2 constituting an implantable part of a control system which further comprises an external data processing device Cl by which commands and any other kind of data can be sent to the control unit C2.
  • the external data processing device Cl may be used to initiate an injection cycle from outside the patient’s body, this being done wirelessly as indicated by arrow 23.
  • the implanted control unit C2 not only controls the motor M inside the housing 12 but also controls energy supply from an accumulator A to the motor M inside the housing 12.
  • the external data processing device Cl may likewise be used to program the implanted control unit C2.
  • a data transfer port for transferring data between the external data processing device Cl and the implanted control unit C2 may be adapted to transfer data in both directions.
  • a feedback sensor F implanted inside the patient’s penis is shown here as being connected to the motor M inside the housing 12 and may likewise be connected to the implantable control unit C2.
  • the feedback sensor F can sense one or more physical parameters of the patient, such as the drug level inside the corpora cavernosa, the flow volume through the corpora cavernosa, the pressure inside the corpora cavernosa and the like.
  • Other feedback sensors may be provided at different locations so as to sense process parameters of the system, such as electrical parameters, distention, distance and the like.
  • conduit 19 connecting the needle 11 with a reservoir comprising compartments R1 and R2 and wiring 24 for transmitting electric energy from the energy source A to the motor M inside the housing 12 are guided through a common conduit 25.
  • the reservoir comprises a first compartment R1 with e.g. a saline solution included therein, and a second compartment R2 with e.g. a drug in powder form or freeze-dried form included therein.
  • a pump P which may be realized as or include a piezoelectric pump or, as shown here, may be driven by a second motor M2, in particular a piezoelectric motor, is arranged to pump infusion liquid from the reservoir R1 to the infusion needle 11.
  • the infusion liquid pumped by the pump P will pass through a mixing chamber 26 into which drugs will be released from the reservoir R2 in appropriate time coordination.
  • the motor M2 or a different motor, in particular a different piezoelectric motor, may cause the drugs to be released from the second reservoir R2.
  • the motor M2 is also controlled by the control unit C2.
  • a pressure sensitive switch for activating the motor M inside the housing 12 and/or the motor M2 may be arranged subcutaneously.
  • the volume of the reservoir R1 is divided into two sections by means of a membrane 31. One section is filled with gas whereas the other section is filled with the infusion liquid (saline solution).
  • An injection port 32 allows for refilling the reservoir R1 with infusion liquid by means of a replenishing needle.
  • the gas section is at ambient pressure or over-pressurized.
  • the pressure in the gas section will decrease below ambient pressure, i.e. to a negative relative value.
  • energy is supplied from outside the patient’s body either for direct use by the motors and/or for charging the accumulator A, which may be in the form of a rechargeable battery and/or a capacitor.
  • An extracorporeal primary energy source E transmits energy of a first form through the patient’s skin 10 to an energy transforming device T which transforms the energy of the first form into energy of a second form, such as electric energy.
  • the electric energy is used to recharge the accumulator A which provides secondary energy to the motor M upon demand.
  • the external primary energy source E may be adapted to create an external field, such as an electromagnetic field, magnetic field or electrical field, or create a wave signal, such as an electromagnetic wave or sound wave signal.
  • the energy transforming device T may act as a solar cell, but adapted to the particular type of wave signal of the primary energy source E.
  • the energy transforming device T may also be adapted to transform temperature changes into electrical energy.
  • an implantable primary energy source E may be used, such as a regular long-life battery instead of the accumulator A.
  • the energy signal may also be used to transmit signals from the external data processing device C 1 by appropriate modulation of the energy signal, regardless of whether the energy is transmitted wirelessly or by wire, the energy signal thereby serving as a carrier wave signal for the digital or analog control signal.
  • the control signal may be a frequency-, phase- and/or amplitude-modulated signal.
  • Fig. 2 shows a second variation of the entire system which basically differs from the system of Fig. 1 only in that the motor M inside the housing 12 is completely dispensed with. Instead, the motor M2 is used to drive the drive unit D. This is achieved by means of a cable 33 replacing the wiring 24 of the system shown in Fig. 1.
  • Figs. 3 and 4 show two different general concepts of how a penetration area 14 can be penetrated by an infusion needle 11 at different penetration sites.
  • the infusion needle 11 is housed in a housing 12 and attached to a needle cooperating member 13 which is movable back and forth in a first direction (X direction) by means of a first actuator 16 and back and forth in a second direction (Y direction) by means of a second actuator 17.
  • the first direction corresponds to a displacement direction of the infusion needle 11, i.e. the direction in which the infusion needle 11 is laterally displaced with respect to the penetration area from one penetration site to the next penetration site.
  • the needle cooperating member 13 is mounted on a cross guide 15 along which the needle cooperating member 13 is movable in the displacement direction.
  • the second direction corresponds to the advancing and retracting direction of the infusion needle 11, i.e. the direction in which the infusion needle 11 is moved so as to penetrate the penetration area 14 whenever an infusion cycle is carried out.
  • the second concept as shown in Fig. 4 differs from the first concept in that, instead of a single laterally movable infusion needle, a plurality of infusion needles 11 is arranged side by side along the penetration area 14, of which only two exemplary infusion needles 11 are shown in Fig. 4.
  • the infusion needle 11 is not fixedly mounted to the needle cooperating member 13.
  • the needle cooperating member 13 comprises a positioning part 13A and a needle driver part 13B.
  • the positioning part 13A is movable along the cross guide 15 in the displacement direction as described above.
  • only the needle driver part 13B is moved in the displacement direction from one infusion needle 11 to the next infusion needle 11.
  • the needle driver part 13B Once the needle driver part 13B has been moved into a desired position adjacent to one of the infusion needles 11, it is advanced by means of the second actuator 17 so as to urge the infusion needle 11 to penetrate the penetration area 14. Thereafter, the respective infusion needle 11 may be retracted by the force of a counteracting spring element or by the needle driver part 13B which, at the end of the process, would need to be detached from the respective infusion needle 11 in order to be further laterally displaced to the next infusion needle 11.
  • the drive unit inside the housing 12 will be described by reference to three exemplary embodiments.
  • the first and second actuators 16, 17 comprise cables.
  • a single cable is used for both laterally displacing as well as advancing and/or retracting the infusion needle 11.
  • a drive unit 100 is shown in Figs. 5 and 6 in a front view and rear view, respectively.
  • the drive unit 100 may be mounted in the housing 12 shown in Figs. 3 and 4.
  • the drive unit 100 comprises a base 101, two parallel linear bearings 102 protruding from opposite ends of the base 101, a translating frame 103 which is slidably movable along the two linear bearings 102 towards and away from the base 101, and two return springs 104, here in the form of coil springs arranged about a respective one of the two linear bearings 102.
  • a needle cooperating member 113 to which the needle 11 is fixedly attached is mounted on a cross guide 115 along which it is movable in a (lateral) displacement direction.
  • the cross guide 115 is fixedly attached with its opposite ends to the translating frame 103 so that movement of the translating frame 103 along the linear bearings 102 towards and away from the base 101 causes the infusion needle 11 to advance and retract in the advancing and retracting direction, respectively.
  • the infusion needle 11 Upon advancement of the infusion needle 11, it penetrates a septum 116 which is arranged adjacent to the penetration area 14 in the housing 12 mentioned above in relation to Figs. 3 and 4.
  • the septum may be arranged in the wall of the housing and form the penetration area 14.
  • the base 101 is stationary with respect to the housing 12, e.g. bonded to or press-fitted into or mechanically held within the housing, so that within the context of the present disclosure elements being fixed to the base 101 and elements being fixed to the housing 12 are to be understood synonymously. This applies to all embodiments.
  • the displacement cable 120 winds around each of the first and second wheels 121, 122 a plurality of times in order to increase friction between the displacement cable 120 and the first and second wheels 121, 122, thereby avoiding slippage of the displacement cable 120.
  • a tensioning element 123 is fixedly held in the translating frame 103 so as to create a tensioning force on the displacement cable 120 in a direction transverse to the longitudinal axis of the displacement cable 120 so as to reduce any slack in the displacement cable 120.
  • the tensioning element 123 is a leaf spring placed in a pocket on the back of the translating frame 103 to maintain the cable tension in the loop.
  • the displacement cable 120 may be realized as a displacement belt, in particular as a toothed displacement belt winding around toothed first and second wheels 121, 122.
  • a drive cable 125 extends from a remote motor, which may be an electric motor, in particular a piezoelectric motor, through the wall of the housing 12 into the housing 12 (not shown).
  • the drive cable 125 may be looped around the first wheel 121 or the second wheel 122 so as to drive the one or the other wheel.
  • a remote motor which may be an electric motor, in particular a piezoelectric motor
  • the drive cable 125 winds around a third wheel 126 mounted on the linear bearing 102, here on the linear bearing 102 on which the first wheel 121 is mounted.
  • the corresponding linear bearing 102 is rotatably mounted in both the base 101 and the translating frame 103 so that turning the wheel 126 by means of the drive cable 125 causes rotation of the linear bearing 102 and first wheel 121 fixedly mounted thereon, thereby causing movement of the displacement cable 120 as described above.
  • the displacement cable 120 may be replaced with the drive cable 125 in that the drive cable 125 may be fixedly connected to the needle cooperating member 113.
  • the drive cable 125 would enter the housing on one side relative to the translating frame 103, loop around the second wheel 122, preferably a plurality of times, on the respective other side of the translating frame 103 and exit the housing again, e.g., on the first side relative to the translating frame 103.
  • the first wheel 121 can be dispensed with.
  • the drive cable 125 being fixedly connected to the needle cooperating member 113 may enter the housing on one side and exit the housing on the other side, in which case both the first and second wheels 121 and 122 can be dispensed with.
  • the displacement cable 120 and/or drive cable 125 winds around a corresponding wheel 121, 122 and/or 126, it may instead wind on and off the corresponding wheel.
  • the cable may be attached to the respective wheel with one end thereof. This will be described further below in relation to the second embodiment.
  • a separate advancement cable 130 is provided. Similar to the drive cable 125, the advancement cable 130 is connected to a remotely arranged motor, i.e. a second motor which may be an electric motor, in particular a piezoelectric motor, and the advancement cable 130 extends from the second motor through the wall of the housing 12 into the housing 12.
  • the basic principle is to connect the advancement cable 130 to the translating frame 103 in such a manner that pulling the advancement cable 130 causes the translating frame 103 to move along the linear bearings 102 towards the base 101.
  • one end of the advancement cable 130 is fixed to the translating frame 103 from which the advancement cable 130 extends downwards towards the base 101 and is further guided out of the housing 12 towards the remote second motor either directly or over a guide wheel.
  • the preferred embodiments shown in Figs. 5 and 6 include a block -and-tackle setup of which the advancement cable 130 forms a part. This setup reduces the amount of power needed to advance the infusion needle 11 through the septum 116 and the penetration area in the wall of the housing 12. Accordingly, the motor for driving the advancement cable 130 may be relatively small, in particular a piezoelectric motor.
  • the end 131 of the advancement cable 130 is crimped and grounded to the base 101.
  • the advancement cable 130 winds twice around one of the two second pulleys 133 so that this pulley is realized as a double pulley.
  • FIG. 7 shows the needle cooperating member 113 to which the infusion needle 11 is mounted. More specifically, the infusion needle 11 is curved and the curved section of the infusion needle 11 is placed in a correspondingly curved recess 114 of the needle cooperating member 113. This facilitates mounting of the infusion needle 11 in a correct position on the needle cooperating member 113 when the system is being assembled.
  • the curved recess 114 provides a counter-force to forces acting on the infusion needle 11 when the infusion needle 11 is advanced to pierce with its front end through the septum 116 and further through the penetration area 14 in the wall of the housing 12.
  • the infusion needle 11 is welded or potted to the needle cooperating member 113 in the area of the recess 114 so as to securely hold the infusion needle 11 in place.
  • An injection port 11A at the front end of the infusion needle 11 is designed as a side port arranged on a side of the tubular needle body 1 IB.
  • a needle-reinforcing tube 20 is placed around the infusion needle 11 to strengthen the tubular needle body 1 IB in order to minimize the deflection of the infusion needle 11 when it penetrates the septum 116 and the penetration area 14 of the housing 12.
  • FIG. 8 shows a perspective view of the needle cooperating member 113 with infusion needle 11 and the base 101.
  • a window 105 is provided in the base 101 to allow the tubing 19 to be routed to the infusion needle 11.
  • the base 101 offers sufficient space for the tubing 19 to be looped inside the housing 12 so that the tubing 19 can cover the full range of motion required when the needle 11 is laterally displaced and/or advanced and retracted.
  • the overall size of the drive unit 100 as shown in this first embodiment may be 40 mm in height, 30 mm in width, and 6 mm in depth, or smaller. This provides enough space for 15 injection sites assuming a space of one millimeter between the centers of adjacent injection sites. Increasing the width of the drive unit will increase the number of injection sites one-to-one, i.e. an increase by one millimeter will increase the number of injection sites by one.
  • the drive unit 200 comprises a base 201, two parallel linear bearings 202 extending from opposite ends of the base 201, a translating frame 203 slidably mounted on the two linear bearings 202 so as to be movable along the linear bearings 202 towards and away from the base 201, and two return springs 204 in the form of coil springs which are respectively mounted around the linear bearings 202.
  • a cross guide 215 is fixedly mounted with its opposite ends to the translating frame 203, and a needle cooperating member 230 is slidable along the cross guide 215 in opposite lateral displacement directions, the displacement directions being different, in particular perpendicular, to the extension direction of the linear bearings 202. Accordingly, by moving the translating frame 203 along the linear bearings 202 towards and away from the base 201, the needle cooperating member 230 is advanced and retracted in opposite advancing and retracting directions along with the infusion needle 11 which is fixedly attached to the needle cooperating member 213.
  • the second embodiment differs from the first embodiment essentially in that a single advanced and displacement cable 240 is provided and arranged to perform both advancement of the infusion needle 11 in the advancement direction and displacement of the infusion needle 11 in the displacement directions.
  • a first actuator such as a first electric motor (not shown), in particular a piezoelectric motor, may be attached to a first end of the advancement and displacement cable 240 and a second actuator, such as a second electric motor (not shown), in particular a piezoelectric motor, may be attached to a second end of the advancement and displacement cable 240.
  • the first and second motors are preferably remote from the housing and, therefore, the first and second ends of the advancement and displacement cable 240 are guided through the wall of the housing 12.
  • the advancement and displacement cable 240 is guided over two first pulleys 232 fixed to the base 201 so as to be stationary and two second pulleys 233 fixed to the translating frame 203 so as to move with the translating frame 203 in the advancing and retracting directions. More specifically, since the advancement and displacement cable 240 is guided over one of the two first pulleys 232 fixed to the base, further to the translating frame 203 and further over the other one of the two first pulleys 232 fixed to the housing, the translating frame is pulled along the linear bearings 202 in a direction towards the two first pulleys 232, i.e.
  • the return springs 204 are arranged to urge the translating frame 203 towards a rest position so that, when the pulling force on the advancement and displacement cable 240 is reduced, the return springs 204 will cause automatic movement of the translating frame 203 back to its rest position shown in Figs. 9 and 10.
  • advancement and displacement cable 240 is not directly attached to the translating frame 203 but is rather attached to the needle cooperating member 213 which, in turn, is movable along the cross guide 215 attached to the translating frame 203, and since it is furthermore guided over the opposed two second pulleys 233 which are fixedly connected to the needle cooperating member 213, pulling the advancement and displacement cable 240 in the one or the other direction, e.g. pulling only one end of the advancement and displacement cable 240, causes the needle cooperating member 113 to move along the cross guide 215, thereby laterally displacing the infusion needle 11 in the displacement direction.
  • both ends of the advancement and displacement cable 240 should be pulled over the same distance in order to avoid that the infusion needle 11 moves laterally while being advanced. It is important to ensure that the return springs 204 are strong enough to prevent movement of the translating frame 203 along the linear bearings 202 when the advancement and displacement cable 240 is tensioned to cause lateral displacement of the needle cooperating member 213.
  • advancement and displacement cable 240 may have a continuous form with a central portion fixed to the needle cooperating member 213, in the embodiment shown in Figs. 9 and 10 the advancement and displacement cable 240 comprises two separate cable sections, each cable section having one end thereof connected to the needle cooperating member 213. Specifically, the respective ends are crimped and held in a crimp pocket 214 formed in the needle cooperating member 213.
  • the second embodiment corresponds to the first embodiment. For instance, upon advancement of the needle cooperating member 213, the infusion needle 11 will penetrate the septum 216 and further into the patient so that a drug may be delivered through the injection port 11A.
  • the infusion needle 11 is a bent needle which is attached and fixed to the needle cooperating member 213 in the same way as described in relation to the first embodiment.
  • a conduit applying the drug to be infused may be attached to the tubing connection 18 at the end of the infusion needle 11 opposite the injection port 11A.
  • the design of the drive unit 200 may be such that there is enough space for 18 injection sites with a distance of one millimeter between the centers of neighboring injection sites. By reducing the number of injection sites from 18 to 16, the width can be further reduced to 30 mm.
  • Figs. 11 and 12 show a front view and a rear view, respectively, of a third embodiment of a drive unit 700.
  • the third embodiment differs from the first and second embodiments mainly in that an array 705 of infusion needles 11 is provided rather than a single infusion needle.
  • the needle cooperating member 713 is moved laterally in the displacement direction to act on and thereby advance one infusion needle 11 of the array 705 of infusion needles 11.
  • the drive unit 700 of the third embodiment comprises a base 701, two linear bearings 702 arranged in parallel and extending from opposite ends of the base 701, a translating frame 703 which is slidably movable along the linear bearings 702 towards and away from the base 701, and two return springs 702 respectively arranged around the linear bearings 702 so as to urge the translating frame 703 away from the base 701 into a rest position.
  • a cross guide 715 in the form of a shaft is fixedly connected with its opposed ends to the translating frame 703.
  • a needle cooperating member 713 is mounted on the cross guide 715 so as to be slidable along the cross guide 715 in opposite displacement directions.
  • the needle cooperating member 713 comprises two components which are separable from each other, namely a needle driver part 713B, which is the component slidably mounted to the cross guide 715, and a positioning part 713A, which is slidably mounted on a secondary cross guide member 715A.
  • the cross guide 715 to which the needle driver part 713B of the needle cooperating member 713 is movably mounted constitutes a main cross guide
  • the secondary cross guide member 715A to which the positioning part 713A of the needle cooperating member 713 is movably mounted constitutes a secondary cross guide.
  • the positioning part 713A and the needle driver part 713B are engaged with each other so that movement of the positioning part 713A along the secondary cross guide member 715A causes a corresponding movement of the needle driver part 713B along the (main) cross guide 715.
  • a protrusion 707 of the positioning part 713A extends into a corresponding recess 708 of the needle driver part 713B.
  • the protrusion 707 can likewise be arranged on the needle driver part 713B and the recess 708 in the positioning part 713A, or any other engagement structure may be provided which holds the positioning part 713A and needle driver part 713B together in the lateral displacement direction but allows disengagement of the positioning part 713A and needle driver part 713B in a direction different, preferably perpendicular, to the displacement direction, i.e. in the advancing direction of the infusion needles.
  • a crimped end 724 of a displacement cable 720 is attached to the positioning part 713A and guided over a wheel 721 towards an actuator, which may be an electric motor outside the housing 12, in particular a piezoelectric motor.
  • Pulling the displacement cable 720 in a first displacement direction causes the positioning part 713A to slide along the secondary cross guide member 715A into the first displacement direction and, since the secondary cross guide member 715A engages the needle driver part 713B, also the needle driver part 713B is caused to move in the same displacement direction along the (main) cross guide 715.
  • a constant-force spring 709 is also attached to the positioning part 713A so as to create a counter-force to the pulling force acting on the displacement cable 720. This helps to hold the positioning part 713 A in position relative to the secondary cross guide member 715A and, thus, the needle driver part 713B relative to the (main) cross guide 715.
  • the spring 709 as a constant-force tensioning spring, the pulling force required to move the needle cooperating member 713 along the cross guide 715 and, thus, the power provided by an associated motor, in particular a piezoelectric motor, is constant independent of the position of the needle cooperating member 713 relative to the cross guide 715.
  • the constant-force tensioning spring 709 comprises a metal band which winds on itself when it is not tensioned. One end of the metal band is attached to a reel and the other end is connected to the positioning part 713A of the needle cooperating member 713.
  • the tensioning spring 709 creates a constant counterforce.
  • the tensioning force provided by the tensioning spring 709 may range between 0.5 N and 2 N, preferably between 0.8 N and 1.2 N, more preferably about 1 N.
  • first and second alignment structures which engage each other so as to define different rest positions for the needle cooperating member 713.
  • One of the alignment structures is stationary with respect to the displacement direction and the other alignment structure is movable along with the needle cooperating member 713.
  • the first alignment structure may be a leaf spring and the second alignment structure may comprise a plurality of stationary detents or protrusions arranged to cooperate with the leaf spring. This concept can likewise be provided in the described first and second embodiments.
  • the first alignment structure is a leaf spring 711 mounted on the needle driver part 713B of the needle cooperating member 713
  • the second alignment structure comprises a plurality of detents or protrusions 710 arranged on the translating frame 703 so as to cooperate with the leaf spring 711.
  • Fig. 14 shows in further detail in Fig. 14.
  • the needle driver part 713B of the needle cooperating member 713 has the protrusion 712 arranged closely to the infusion needles 11, namely slightly above the infusion needles 11, so that, when the translating frame 703 moves downwards in the advancing direction, the protrusion 712 pushes a respective one of the infusion needles 11 downwards in the advancing direction.
  • Fig. 11 relating to the third embodiment shows a block-and-tackle setup comprising an advancement cable 730 which is fixed with its free end 731 to the base 701 and which is guided along two first pulleys 732 mounted on the translating frame 703 and two second pulleys 733 fixedly mounted to the base 701 and, thus, to the housing 12.
  • the advancement cable 730 may be pulled so that the needle driver part 713B of the needle cooperating member 713 moves downwards along with the translating frame 703, thereby, on the one hand, disengaging from the positioning part 713A of the needle cooperating member 713 and, on the other hand, urging the respective one infusion needle 11 of the needle array 705 downwards in the advancing direction.
  • Fig. 15 shows only some relevant parts of the drive unit 700. Accordingly, the needle driver part 713B is shown in a disengaged position in which it has already pushed one infusion needle 11 of the needle array 705 through the penetration area 14 of the housing 12 (not shown) into a vein 2 of the patient. Once the tension on the advancement cable 730 is released, the advanced infusion needle 11 will automatically be retracted into its rest position by means of the return springs 704. More specifically, a crossbar 703 A of the translating frame 703 is arranged below a sideways extension 11C of the infusion needles 11, as is shown in Fig. 11, so that the crossbar 703A contacts the sideways extension 11C and moves the infusion needle 11 upwards when the translating frame 713 is urged back into its rest position.
  • Fig. 15 further illustrates how drugs may be delivered through the infusion needle 11 into the patient.
  • This concept utilizes infusion needles 11 having a feeding port 1 ID arranged distant from the tip end of the infusion needle 11 on a side of the tubular needle body 1 IB.
  • the substance to be injected is fed sideways into the tubular needle body 1 IB.
  • a needle lumen (not shown) inside the tubular needle body 1 IB connects the feeding port 1 ID with the injection port 11A, which is also realized as a side port, as discussed above.
  • the septum 716 comprises an upper septum 716A and a lower septum 716B as well as an internal reservoir 717 between the upper septum 716A and lower septum 716B.
  • the infusion needles 11 extend through the upper septum 716A, internal reservoir 717 and lower septum 716B. In their retracted positions, the feeding ports 1 ID are protected in the upper septum 716A and the injection ports 11A are protected in the lower septum 716B.
  • the feeding port 1 ID is positioned inside the internal reservoir 717 and the injection port 11A is positioned outside the housing 12, thereby allowing the substance to be injected to flow from the internal reservoir 717 through the feeding port 1 ID and inner lumen of the tubular needle body 1 IB towards and through the injection port 11A into the patient’s body.
  • the spacing between the feeding port 1 ID and injection port 11A is selected to ensure that the injection port 11A is fully inserted in the patient before the feeding port 1 ID accesses the internal reservoir 717.
  • a supply lumen 750 for supplying the substance to be injected to the internal reservoir 717 is arranged so as to run along an inner lumen of the linear bearing 702.
  • the inner lumen connects directly to the internal reservoir 717, as shown in Fig. 15.
  • the overall size of the drive unit 700 is preferably no more than 46 mm in height, 33 mm in width and 8.5 mm in depth. This allows about 14 discrete injection sites in the needle array 705 spaced by 1.5 mm center-to-center distance.
  • the communication between external devices or between an external device and the implant may be encrypted.
  • Any suitable type of encryption may be employed such as symmetric or asymmetric encryption.
  • the encryption may be a single key encryption or a multi -key encryption.
  • multi-key encryption several keys are required to decrypt encrypted data.
  • the several keys may be called first key, second key, third key, etc. or first part of a key, second part of the key, third part of the key, etc.
  • the several keys are then combined in any suitable way (depending on the encryption method and use case) to derive a combined key which may be used for decryption.
  • deriving a combined key is intended to mean that each key is used one by one to decrypt data, and that the decrypted data is achieved when using the final key.
  • the combination of the several keys results in one “master key” which will decrypt the data.
  • it is a form of secret sharing, where a secret is divided into parts, giving each participant (external device(s), internal device) its own unique part.
  • all keys are needed to reconstruct the original secret, to achieve the combined key which may decrypt the data.
  • the generator of a key for decryption is the unit that in the end sends the key to another unit to be used at that unit.
  • the generator of a key is merely a facilitator of encryption/decryption, and the working on behalf of another device/user.
  • a verification unit may comprise any suitable means for verifying or authenticating the use (i.e. user authentication) of a unit comprising or connected to the verification unit, e.g. the external device.
  • a verification unit may comprise or be connected to an interface (UI, GUI) for receiving authentication input from a user.
  • the verification unit may comprise a communication interface for receiving authentication data from a device (separate from the external device) connected to the device comprising the verification unit.
  • Authentication input/data may comprise a code, a key, biometric data based on any suitable techniques such as fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison, etc.
  • the verification/authentication may be provided using third-party applications, installed at or in connection with the verification unit.
  • the verification unit may be used as one part of a two-part authentication procedure.
  • the other part may e.g. comprise conductive communication authentication, sensation authentication, or parameter authentication.
  • the verification unit may comprise a card reader for reading a smart card.
  • a smart card is a secure microcontroller that is typically used for generating, storing and operating on cryptographic keys.
  • Smart card authentication provides users with smart card devices for the purpose of authentication. Users connect their smart card to the verification unit. Software on the verification unit interacts with the key’s material and other secrets stored on the smart card to authenticate the user. In order for the smart card to operate, a user may need to unlock it with a user PIN. Smart cards are considered a very strong form of authentication because cryptographic keys and other secrets stored on the card are very well protected both physically and logically, and are therefore hard to steal.
  • the verification unit may comprise a personal e-ID that is comparable to, for example, passport and driving license.
  • the e-ID system comprises is a security software installed at the verification unit, and an e-ID which is downloaded from a website of a trusted provider or provided via a smart card from the trusted provider.
  • the verification unit may comprise software for SMS-based two-factor authentication. Any other two-factor authentication systems may be used. Two-factor authentication requires two things to get authorized: something you know (your password, code, etc.) and something you have (an additional security code from your mobile device (e.g. an SMS or an e-ID) or a physical token such as a smart card).
  • verification/user authentication may be employed.
  • a verification unit which communicates with an external device using visible light instead of wired communication or wireless communication using radio.
  • a light source of the verification unit may transmit (e.g. by flashing in different patterns) secret keys or similar to the external device which uses the received data to verify the user, decrypt data or by any other means perform authentication.
  • Light is easier to block and hide from an eavesdropping adversary than radio waves, which thus provides an advantage in this context.
  • electromagnetic radiation is used instead of visible light for transmitting verification data to the external device.
  • Parameters relating to functionality of the implant may be subject of the communication and comprise sensitive information, for example a status indicator of the implant such as battery level, version of control program, properties of the implant, status of a motor of the implant, etc.
  • data comprising operating instructions may be subject of the communication and comprise other sensitive information, for example a new or updated control program, parameters relating to specific configurations of the implant, etc.
  • Such data may for example comprise instructions on how to operate the electrical stimulation device and/or implantable constriction device, instructions to collect patient data, instructions to transmit feedback, etc.
  • FIG. 16A shows a patient when an implantable medical device M comprising a controller 300 has been implanted, such as for example the constriction devices in the form of the exit and entry valves 30, 40 and/or electrical stimulation devices 10 with the controllers Ci and/or CE described above.
  • the implantable medical device M comprises an active unit 302, which is a part of the electrical stimulation devices and/or mechanical or hydraulic constriction device and which comprises the one or more operable elements, valves, ports, etc.
  • the active unit 302 is directly or indirectly connected to the body of the patient for acting on the intestine.
  • the active unit 302 is connected to the controller 300 via an electrical connection C2.
  • the controller 300 (further described with reference to Fig. 16B) is configured to communicate with an external device 320 (further described with reference to Fig. 16C).
  • the controller 300 can communicate wirelessly with the external device 320 through a wireless connection WL1 and/or through an electrical connection Cl.
  • the controller 300 comprises an internal computing unit 306 configured to control the function performed by the implantable medical device MD.
  • the computing unit 306 comprises an internal memory 307 configured to store programs therein.
  • the internal memory 307 comprises a first control program 310 which can control the function of the implantable medical device MD.
  • the first control program 310 may be seen as a program with minimum functionality to be run at the implantable medical device M only during updating of the second control program 312.
  • the implantable medical device M may be seen as running in safe mode, with reduced functionality.
  • the first control program 310 may result in that no sensor data is stored in the implantable medical device M while being run, or that no feedback is transmitted from the implantable medical device M while the first control program 310 is running.
  • memory at the implantable medical device M is saved, and the risk of failure of the implantable medical device M during updating of the second control program 312 is reduced.
  • the second control program 312 is the program controlling the implantable medical device M in normal circumstances, providing the implantable medical device M with full functionality and features.
  • the memory 307 can further comprise a second, updatable, control program 312.
  • the term updatable is to be interpreted as the program being configured to receive incremental or iterative updates to its code or be replaced by a new version of the code. Updates may provide new and/or improved functionality to the implant as well as fixing previous deficiencies in the code.
  • the computing unit 306 can receive updates to the second control program 312 via the controller 300. The updates can be received wirelessly via WL1 or via the electrical connection Cl. As shown in Fig. 16B, the internal memory 307 of the controller 300 can possibly store a third program 314.
  • the third program 314 can control the function of the implantable medical device M, and the computing unit 306 may be configured to update the second program 312 to the third program 314.
  • the third program 314 can be utilized when rebooting an original state of the second program 312.
  • the third program 314 may thus be seen as providing a factory reset of the controller 300, e.g. restore it back to factory settings.
  • the third program 314 may thus be included in the implant 300 in a secure part of the memory 307 to be used for resetting the software (second control program 312) found in the controller 300 to original manufacturer settings.
  • the controller 300 may comprise a reset function 316 connected to or part of the internal computing unit 306 or transmitted to said internal computing unit 306.
  • the reset function 316 is configured to make the internal computing unit 306 switch from running the second control program 312 to the first control program 310.
  • the reset function 316 may be configured to make the internal computing unit 306 delete the second control program 312 from the memory 307.
  • the reset function 316 can be operated by palpating or pushing/put pressure on the skin of the patient. This may be performed by having a button on the implant. Alternatively, the reset function 316 can be invoked via a timer or a reset module. Temperature sensors and/ or pressure sensors can be utilized for sensing the palpating.
  • the reset function 316 may also be operated by penetrating the skin of the patient. It is further plausible that the reset function 316 can be operated by magnetic means. This may be performed by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 may be configured such that it responds only to magnetic forces applied for a duration of time exceeding a limit, such as 2 seconds. The time limit may equally plausible be 5 or 10 seconds, or longer. In these cases, the implant may comprise a timer. The reset function 316 may thus include or be connected to a sensor for sensing such magnetic force.
  • the implant may comprise an internal computing unit 306 (comprising an internal processor) comprising the second control program 312 for controlling a function of the implantable medical device M, and a reset function 318.
  • the reset function 318 may be configured to restart or reset said second control program 312 in response to: i. a timer of the reset function 318 not having been reset, or ii. a malfunction in the first control program 310.
  • the reset function 318 may comprise a first reset function, such as, for example, a computer operating properly, COP, function connected to the internal computing unit 306.
  • the first reset function may be configured to restart or reset the first or the second control program 312 using a second reset function.
  • the first reset function comprises a timer, and the first or the second control program is configured to periodically reset the timer.
  • the reset function 318 may further comprise a third reset function connected to the internal computing unit and to the second reset function.
  • the third reset function may in an example be configured to trigger a corrective function for correcting the first 310 or second control program 312, and the second reset function is configured to restart the first 310 or second control program 312 sometime after the corrective function has been triggered.
  • the corrective function may be a soft reset or a hard reset.
  • the second or third reset function may, for example, configured to invoke a hardware reset by triggering a hardware reset by activating an internal or external pulse generator which is configured to create a reset pulse.
  • the second or third reset function may be implemented by software.
  • the controller 300 may further comprise an internal wireless transceiver 308.
  • the transceiver 308 communicates wirelessly with the external device 320 through the wireless connection WL1.
  • the transceiver may further communicate with an external device 320, 300 via wireless connection WL2 or WL4.
  • the transceiver may both transmit and receive data via either of the connections Cl, WL1, WL2 and WL4.
  • the external devices 320 and 300 when present, may communicate with each other, for example via a wireless connection WL3.
  • the controller 300 can further be electrically connected Cl to the external device 320 and communicate by using the patient’s body as a conductor.
  • the controller 300 may thus comprise a wired transceiver 303 or an internal transceiver 303 for the electrical connection Cl.
  • the controller 300 of the implantable medical device M according to Fig. 16B further comprises a feedback unit 349.
  • the feedback unit 349 provides feedback related to the switching from the second control program 312 to the first control program 310.
  • the feedback may for example represent the information on when the update of the software, i.e. the second control program 312, has started, and when the update has finished.
  • This feedback can be visually communicated to the patient, via for example a display on the external device 320.
  • This display may be located on a wristwatch, or a phone, or any other external device 320 coupled to the controller 300.
  • the feedback unit 349 provides this feedback signal wirelessly via WL1 to the external device 320.
  • the words “Update started”, or “Update finished”, may be displayed to the patient, or similar terms with the same meaning.
  • Another option may be to display different colors, where green for example may mean that the update has finished, and red or yellow that the update is ongoing. Obviously, any color is equally plausible, and the user may choose these depending on personal preference.
  • Another possibility would be to flash a light on the external device 320.
  • the external device 320 comprises the light emitting device(s) needed.
  • Such light may for example be an LED.
  • Different colors may, again, represent the status of the program update.
  • One way of representing that the update is ongoing and not yet finished may be to flash the light, i.e. turning the light on and off. Once the light stops flashing, the patient would be aware of that the update is finished.
  • the feedback may also be audible and provided by the implantable constriction device M directly, or by the external device 320.
  • the implantable medical device M and external device 320 comprise means for providing audio.
  • the feedback may also be tactile, for example in the form of a vibration that the user can sense.
  • either the implantable medical device M or external device 320 comprises means for providing a tactile sensation, such as a vibration and/or a vibrator.
  • the controller 300 can further comprise a first energy storage unit 40A.
  • the first energy storage unit 40A runs the first control program 310.
  • the controller 300 further comprises a second energy storage unit 40B which runs the second control program 312. This may further increase security during an update, since the first control program 310 has its own separate energy storage unit 40A.
  • the first power supply 40A can comprise a first energy storage 304a and/or a first energy receiver 305a.
  • the second energy storage unit 40B can comprise a second energy storage 304b and/or a second energy receiver 305b.
  • the energy can be received wirelessly by inductive or conductive means.
  • An external energy storage unit can for example transfer an amount of wireless energy to the energy receivers 305a, 305b inside the patient’s body by utilizing an external coil which induces a voltage in an internal coil (not shown in Figures). It is plausible that the first energy receiver 305a receives energy via an RFID pulse.
  • the feedback unit 349 can provide feedback pertaining to the amount of energy received via the RFID pulse. The amount of RFID pulse energy that is being received can be adjusted based on the feedback, such that the pulse frequency is successively raised until a satisfying level is reached.
  • the controller 300 of the implantable medical device M according to Fig. 16B further comprises an electrical switch 309.
  • the electrical switch 309 may be mechanically connected to an implantable element configured to exert a force on a body portion of a patient and being configured to be switched as a result of the force exerted on the body portion of a patient exceeding a threshold value.
  • the switch 309 may for example be bonded to a portion of the implantable medical device M in any of the embodiments herein.
  • the switch 309 may alternatively be electrically connected to the implantable medical device M and configured to be switched as a result of the current supplied to the implantable medical device M exceeding a threshold value.
  • the switch 309 may for example be connected to the electrical stimulation devices 10 and/or the constriction devices in the form of the exit and entry valves 30, 40 and configured to be switched if the current to the implantable medical device M exceeds a threshold value.
  • a switch may for example be a switch 309 configured to switch if exposed to a temperature exceeding a threshold value, such as a bimetal switch which is switched by the heat created by the flow of current to e.g. the electrodes of the electrical stimulation devices 10 or a motor of the mechanical or hydraulic constriction devices.
  • the switch 309 configured to switch if exposed to a temperature exceeding a threshold value may be placed at a different location on the implantable medical device M to switch in case of exceeding temperatures, thereby hindering the implantable medical device M from overheating which may cause tissue damage.
  • the switch 309 may either be configured to cut the power to the operation device or to generate a control signal to the processor 306 of the implantable controller 300, such that the controller 300 can take appropriate action, such as reducing power or turning off the operation of the implantable medical device M.
  • the external device 320 is represented in Fig. 16C.
  • the external device 320 can be placed anywhere on the patient’s body, preferably at a convenient and comfortable place.
  • the external device 320 may be a wristband, and/or have the shape of a wristwatch. It is also plausible that the external device is a mobile phone or other device not attached directly to the patient.
  • the external device 320 as shown in Fig. 16C comprises a wired transceiver 323, and an energy storage 324. It also comprises a wireless transceiver 328 and an energy transmitter 325. It further comprises a computing unit 326 and a memory 327.
  • the feedback unit 322 in the external device 320 is configured to provide feedback related to the computing unit 326.
  • the feedback provided by the feedback unit 322 may be visual.
  • the external device 320 may have a display showing such visual feedback to the patient. It is equally plausible that the feedback is audible and that the external device 320 comprises means for providing audio.
  • the feedback given by the feedback unit 322 may also be tactile, such as vibrating.
  • the feedback may also be provided in the form of a wireless signal WL1, WL2, WL3, WL4.
  • the second, third or fourth communication method WL2, WL3, WL4 may be a wireless form of communication.
  • the second, third or fourth communication method WL2, WL3, WL4 may preferably be a form of electromagnetic or radio-based communication.
  • the second, third and fourth communication method WL2, WL3, WL4 may be based on telecommunication methods.
  • the second, third or fourth communication method WL2, WL3, WL4 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G or 5G.
  • the external device 320 may be adapted to be in electrical connection Cl with the implantable medical device M, using the body as a conductor.
  • the electrical connection Cl is in this case used for conductive communication between the external device 320 and the implantable medical device M.
  • the communication between controller 300 and the external device 320 over either of the communication methods WL2, WL3, WL4, Cl may be encrypted and/or decrypted with public and/or private keys, now described with reference to Figs. 16A to 13c.
  • the controller 300 may comprise a private key and a corresponding public key
  • the external device 320 may comprise a private and a corresponding public key.
  • the controller 320 and the external device 320 may exchange public keys and the communication may thus be performed using public key encryption.
  • the person skilled in the art may utilize any known method for exchanging the keys.
  • the controller may encrypt data to be sent to the external device 320 using a public key corresponding to the external device 320.
  • the encrypted data may be transmitted over a wired, wireless or electrical communication channel Cl, WL1, WL2, WL3 to the external device.
  • the external device 320 may receive the encrypted data and decode it using the private key comprised in the external device 320, the private key corresponding to the public key with which the data has been encrypted.
  • the external device 320 may transmit encrypted data to the controller 300.
  • the external device 320 may encrypt the data to be sent using a public key corresponding to the private key of the controller 300.
  • the external device 320 may transmit the encrypted data over a wired, wireless or electrical connection Cl, WL1, WL2, WL3, WL4, directly or indirectly, to the controller of the implant.
  • the controller may receive the data and decode it using the private key comprised in the controller 300.
  • the data to be sent between the controller 300 of the implantable medical device M and an external device 320, 330 or between an external device 320, 330 and the controller 300 may be signed.
  • the data to be sent from the controller 300 may be signed using the private key of the controller 300.
  • the data may be transmitted over a communication channel or connection Cl, WL1, WL2, WL3, WL4.
  • the external device 320, 330 may receive the message and verify the authenticity of the data using the public key corresponding to the private key of the controller 300.
  • a method for communication between an external device 320 and the controller 300 of the implantable medical device M using a combined key is now described with reference to Figs. 16A to 16C.
  • a first step of the method comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, WL4 or otherwise, a first key from an external device 320, 330.
  • the method further comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, a second key.
  • the second key may be generated by a second external device, separate from the external device 320, 330 or by another external device being a generator of the second key on behalf of the second external device 320, 330.
  • the second key may be received at the implant from any one of: the external device 320, the second external device 330, and the generator of the second key.
  • the second external device may be controlled by a caretaker or any other stakeholder. Said another external device may be controlled by a manufacturer of the implant, or medical staff, caretaker, etc.
  • the controller 300 is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from another external device (generator).
  • the routing may be performed as described herein under the tenth aspect.
  • the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing.
  • Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.
  • the controller 300 comprises a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller 300.
  • the third key may for example be a license number of the implant or a chip number of the implantable medical device MD.
  • the combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300.
  • the decrypted data may be used for altering, by the computing unit 306, an operation of the implantable medical device MD.
  • the altering of an operation of the implantable medical device M may comprise controlling or switching an active unit 302 of the implant.
  • the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the controller 300, and operating the implantable medical device M using operation instructions in the decrypted data.
  • Methods for encrypted communication between an external device 320 and the controller 300 may comprise: receiving, at the external device 320, by a wireless transceiver 328, a first key, the first key being generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 330, the first key being received from any one of the second external device 330 and the generator of the second key, receiving, at the external device 320 by the wireless transceiver 328, a second key from the controller 300, deriving a combined key, by a computing unit 326 of the external device 320, by combining the first key and the second key with a third key held by the external device 320 (e.g. in memory 307), transmitting encrypted data from the implant to the external device and receiving the encrypted data at the external device by the wireless transceiver 328, and decrypting, by the computing unit 326, the encrypted data, in the external device 320, using the combined key.
  • the wireless transceiver 328 is configured for: receiving a fourth key from a third external device, wherein the computing unit 326 is configured for: deriving a combined key by combining the first, second and fourth key with the third key held by the external device, and decrypting the encrypted data using the combined key.
  • the computing unit 326 may be configured to confirm the communication between the implant and the external device, wherein the confirmation comprises: measuring a parameter of the patient, by the external device 320, receiving a measured parameter of the patient, from the implantable medical device M, comparing the parameter measured by the implantable medical device M with the parameter measured by the external device 320, performing confirmation of the connection based on the comparison, and as a result of the confirmation, decrypting the encrypted data, in the external device, using the combined key.
  • the keys described in this section may in some embodiments be generated based on data sensed by sensors described hereinafter, e.g. using the sensed data as seed for the generated keys.
  • a seed is an initial value that is fed into a pseudo-random number generator to start the process of random number generation. The seed may thus be made hard to predict without access to or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.
  • FIG. 16A to 16C A method of communication between an external device 320 and an implantable medical device MD is now described with reference to Figs. 16A to 16C, when the implantable medical device MD is implanted in a patient and the external device 320 is positioned external to the body of the patient.
  • the external device 320 is adapted to be in electrical connection Cl with the controller 300, using the body as a conductor.
  • the electrical connection Cl is used for conductive communication between the external device 320 and the implantable medical device MD.
  • the implantable medical device MD comprises the controller 300.
  • Both the controller 300 and the external device 320 comprise a wireless transceiver 308 for wireless communication Cl between the controller 300 and the external device 320.
  • the wireless transceiver 308 (included in the controller 300) may in some embodiments comprise sub-transceivers for receiving data from the external device 320 and other external devices, e.g. using different frequency bands, modulation schemes, etc.
  • the electrical connection Cl between the controller 300 and the external device 320 is confirmed and thus authenticated.
  • the confirmation and authentication of the electrical connection may be performed as described hereinafter.
  • the implant and/or external device(s) comprise the necessary features and functionality (described in the respective sections of this document) for performing such authentication.
  • security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.
  • the controller 300 of the implanted medical device MD may comprise a first transceiver 303 configured to be in electrical connection Cl with the external device 320, using the body as a conductor.
  • the first transceiver 303 of the controller 300 may be wireless.
  • the external device 320 may comprise a first external transmitter 323 configured to be in electrical connection Cl with the implanted medical device M, using the body as a conductor, and a wireless transmitter configured to transmit wireless communication WL1 to the controller 300.
  • the first external transmitter 323 of the external device 320 may be wireless.
  • the first external transmitter 323 and the wireless transmitter of the external device 320 may be the same or separate transmitters.
  • the controller 300 may comprise a computing unit 306 configured to confirm the electrical connection between the external device 320 and the internal transceiver 303 and accept wireless communication WL1 (of the data) from the external device 320 on the basis of the confirmation.
  • Data is transmitted from the external device 320 to the controller 300 wirelessly, e.g. using the respective wireless transceivers of the controller 300 and the external device 320. Data may alternatively be transmitted through the electrical connection C 1. As a result of the confirmation, the received data may be used for instructing the implantable medical device MD. For example, a control program 310 running in the controller 300 may be updated or the controller 300 may be operated using operation instructions in the received data. This may be handled by the computing unit 306.
  • the method may comprise transmitting data from the external device 320 to the controller 300 wirelessly which may comprise transmitting encrypted data wirelessly.
  • To decrypt the encrypted data (for example using the computing unit 306), several methods may be used.
  • a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300.
  • the key is received at the controller (by the first internal transceiver 303).
  • the key is then used for decrypting the encrypted data.
  • the key is enough to decrypt the encrypted data. In other embodiments, further keys are necessary to decrypt the data.
  • a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller 300 (by the first internal transceiver 303). A second key is transmitted (by the wireless transceiver 208) from the external device 320 using the wireless communication WL1 and received at the controller 300 by the wireless transceiver 308. The computing unit 306 then derives a combined key from the key and second key and uses this for decrypting the encrypted data.
  • a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300.
  • the key is received at the controller (by the first internal transceiver 303).
  • a third key is transmitted from a second external device 330, separate from the external device 320, to the implant wirelessly via WL2.
  • the third key may be received by a second wireless receiver (part of the wireless transceiver 308) of the controller 300 configured for receiving wireless communication via WL2 from the second external device 330.
  • the first and third key may be used to derive a combined key by the computing unit 306, which then decrypts the encrypted data.
  • the decrypted data is then used for instructing the implantable medical device MD as described above.
  • the second external device 330 may be controlled by, for example, a care person to further increase security and validity of data sent and decrypted by the controller 300.
  • the external device is further configured to receive WL2 secondary wireless communication from the second external device 330, and transmit data received from the secondary wireless communication WL2 to the implantable medical device MD.
  • This routing of data may be achieved using the wireless transceivers 308, 208 (i.e. the wireless connection WL1), or by using a further wireless connection WL4 between the controller 300 and the external device 320.
  • the implant and/or external device(s) comprise(s) the necessary features and functionality for performing such routing. Consequently, in some embodiments, the third key is generated by the second external device 330 and transmitted via WL2 to the external device 320 which routes the third key to the controller 300 to be used for decryption of the encrypted data.
  • the step of transmitting a third key from a second external device, separate from the external device, to the implant wirelessly comprises routing the third key through the external device 320.
  • the external device 320 as a relay, with or without verification by the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.
  • a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300.
  • the key is received at the implant (by the first internal transceiver 303).
  • a second key is transmitted from the external device 320 to the controller 300 wirelessly via WL1, received at the controller 300.
  • a third key is transmitted from the second external device, separate from the external device 320, to the controller 300 wirelessly via WL4. Encrypted data transmitted from the external device 320 to the controller 300 is then decrypted using a derived combined key from the key, the second key and the third key.
  • the external device may be a wearable external device.
  • the external device 320 may be a handset.
  • the second external device 330 may be a handset or a server or may be cloud-based.
  • the electrical connection Cl between the external device 320 and the controller 300 is achieved by placing a conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication Cl with the implant.
  • the implant and/or external device(s) comprise(s) the necessary features and functionality (described in the respective sections of this document) for performing such conductive communication.
  • the communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 321, conductive connection Cl, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient.
  • the external device 320 comprises a verification unit 340.
  • the verification unit 340 may be any type of unit suitable for verification of a user, i.e. configured to receive authentication input from a user, for authenticating the conductive communication between the implant and the external device.
  • the verification unit and the external device comprise means for collecting authentication input from the user (which may or may not be the patient). Such means may comprise a fingerprint reader, a retina scanner, a camera, a GUI for inputting a code, a microphone, a device configured to draw blood, etc.
  • the authentication input may thus comprise a code or anything based on a biometric technique selected from the list of: a fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison.
  • the means for collecting the authentication input may alternatively be part of the conductive member 321 which comprise any of the above examples of functionality, such as a fingerprint reader or other type of biometric reader.
  • the security may thus be increased by receiving an authentication input from a user by the verification unit 340 of the external device 320 and authenticating the conductive communication between the controller 300 and the external device using the authentication input.
  • the conductive communication channel C 1 may be employed for comprising transmitting a conductive communication to the controller 300 by the external device 320 and/or transmitting a conductive communication to the external device 320 by the controller 300.
  • a positive authentication is needed prior to operating the implantable medical device MD based on received conductive communication and/or updating a control program running in the controller 300 as described above.
  • Figs. 16A to 16C further show that the implantable medical device MD is connected to a sensation generator 381.
  • the sensation generator 381 may be configured to generate a sensation.
  • the sensation generator 381 may be contained within the implantable medical device MD or be a separate unit.
  • the sensation generator 381 may be implanted.
  • the sensation generator 381 may also be located so that it is not implanted as such but still is in connection with a patient so that only the patient may experience sensations generated.
  • the controller 300 is configured for storing authentication data, related to the sensation generated by the sensation generator 381.
  • the controller 300 is further configured for receiving input authentication data from the external device 320.
  • Authentication data related to the sensation generated may be stored by a memory 307 of the controller 300.
  • the authentication data may include information about the generated sensation such that it may be analyzed, e.g. compared, to input authentication data to authenticate the connection, communication or device.
  • Input authentication data relates to information generated by a patient input to the external device 320.
  • the input authentication data may be the actual patient input or an encoded version of the patient input, encoded by the external device 320.
  • Authentication data and input authentication data may comprise a number of sensations or sensation components.
  • the authentication data may comprise a timestamp.
  • the input authentication data may comprise a timestamp of the input from the patient.
  • the timestamps may be a time of the event such as the generation of a sensation by the sensation generator 381 or the creation of input authentication data by the patient.
  • the timestamps may be encoded.
  • the timestamps may feature arbitrary time units, i.e. not the actual time. Timestamps may be provided by an internal clock 360 of the controller 300 and an external clock 362 of the external device 320.
  • the clocks 360, 362 may be synchronized with each other.
  • the clocks 360, 362 may be synchronized by using a conductive connection Cl or a wireless connection WL1 for communicating synchronization data from the external device 320, and its respective clock 362, to the controller 300, and its respective clock 360, and vice versa.
  • Synchronization of the clocks 360, 362 may be performed continuously and may not be reliant on secure communication.
  • Authentication of the connection may comprise calculating a time difference between the timestamp of the sensation and the time stamp of the input from the patient, and upon determining that the time difference is less than a threshold, authenticating the connection.
  • a threshold may be 1 s.
  • the analysis may also comprise a low threshold as to filter away input from the patient that is faster than normal human response times. The low threshold may e.g. be 50 ms.
  • Authentication data may comprise a number of times that the sensation is generated by the sensation generator, and wherein the input authentication data comprises an input from the patient relating to a number of times the patient detected the sensation.
  • Authenticating the connection may then comprise: upon determining that the number of times that the authentication data and the input authentication data are equal, authenticating the connection.
  • a method of authenticating the connection between the implantable medical device MD and the external device 320 accordingly includes the following steps.
  • the sensation generator 381 Generating, by the sensation generator 381, a sensation detectable by a sense of the patient.
  • the sensation may comprise a plurality of sensation components.
  • the sensation or sensation components may comprise a vibration (e.g. a fixed frequency mechanical vibration), a sound (e.g. a superposition of fixed-frequency mechanical vibrations), a photonic signal (e.g. a non-visible light pulse such as an infrared pulse), a light signal (e.g. a visual light pulse), an electrical signal (e.g. an electrical current pulse) or a heat signal (e.g. a thermal pulse).
  • a vibration e.g. a fixed frequency mechanical vibration
  • a sound e.g. a superposition of fixed-frequency mechanical vibrations
  • a photonic signal e.g. a non-visible light pulse such as an infrared pulse
  • a light signal e.g. a visual light pulse
  • an electrical signal e.g. an electrical current pulse
  • the sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm. Sensations may be configured to be consistently felt by a sense of the patient while not risking harm to or affecting internal biological processes of the patient.
  • Providing, by the patient, input to the external device, resulting in input authentication data may e.g. comprise engaging an electrical switch, using a biometric input sensor or entering the input into a digital interface running on the external device 320, to name just a few examples.
  • the wireless connection WL1 or the conductive connection Cl may be used to communicate the further data.
  • the further data may comprise data for updating a control program 310 running in the controller 300 or operation instructions for operating the implantable medical device M.
  • the external device 320 may continuously request or receive information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the external device 320, that the connection is authenticated, transmit further data from the external device 320 to the controller 300.
  • the controller 300 may continuously request or receive information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the controller 300, that the connection is authenticated, transmit further data from the controller 300 to the external device 320.
  • a main advantage of authenticating a connection according to this method is that only the patient may be able to experience the sensation. Thus, only the patient may be able to authenticate the connection by providing authentication input corresponding to the sensation generation.
  • the communication unit 300 or internal controller 300 or control unit 300 comprises a wireless transceiver 308 for communicating wirelessly with an external device, a security module 389, and a central unit, also referred to herein as a computing unit 306 306, which is to be considered as equivalent.
  • the central unit 306 is configured to be in communication with the wireless transceiver 308, the security module 389 and the implantable medical device or active unit 302.
  • the wireless transceiver 308 is configured to receive communication from the external device 320 including at least one instruction to the implantable medical device MD and transmit the received communication to the central unit or computing unit 306.
  • the central unit or computing unit 306 is configured to send secure communication to the security module 389, derived from the received communication from the external device 320, and the security module 389 is configured to decrypt at least a portion of the secure communication and verify the authenticity of the secure communication.
  • the security module is further configured to transmit a response communication to the central unit or computing unit 306 and the central unit or computing unit is configured to communicate the at least one instruction to the active unit 302.
  • the at least one instruction is based on the response communication, or a combination of the response communication and the received communication from the external device 320.
  • the security module 389 comprises a set of rules for accepting communication from the central unit or computing unit 306.
  • the wireless transceiver 308 is configured to be able to be placed in an off-mode, in which no wireless communication can be transmitted or received by the wireless transceiver 308.
  • the set of rules comprises a rule stipulating that communication from the central unit or computing unit 306 to the security module 389 or to the active unit 302 is only accepted when the wireless transceiver 308 is placed in the off-mode.
  • the set of rules comprises a rule stipulating that communication from the central unit or computing unit 306 is only accepted when the wireless transceiver 308 has been placed in the off-mode for a specific time period.
  • the central unit or computing unit 306 is configured to verify a digital signature of the received communication from the external device 320.
  • the digital signature could be a hash-based digital signature which could be based on a biometric signature from the patient or a medical professional.
  • the set of rules further comprises a rule stipulating that communication from the central unit 306 is only accepted when the digital signature of the received communication has been verified by the central unit 306.
  • the verification could for example comprise the step of comparing the digital signature or a portion of the digital signature with a previously verified digital signature stored in the central unit 306.
  • the central unit 306 may be configured to verify the size of the received communication from the external device and the set of rules could comprise a rule stipulating that communication from the central unit 306 is only accepted when the size of the received communication has been verified by the central unit 306.
  • the central unit could thus have a rule stipulating that communication above or below a specified size range is to be rejected.
  • the wireless transceiver is configured to receive a message from the external device 320 being encrypted with at least a first and second layer of encryption.
  • the central unit 306 the decrypts the first layer of decryption and transmit at least a portion of the message comprising the second layer of encryption to the security model 389.
  • the security module 389 then decrypts the second layer of encryption and transmits a response communication to the central unit 306 based on the portion of the message decrypted by the security module 389.
  • the central unit 306 is configured to decrypt a portion of the message comprising a digital signature, such that the digital signature can be verified by the central unit 306, also the central unit 306 is configured to decrypt a portion of the message comprising message size information, such that the message size can be verified by the central unit 306.
  • the central unit 306 is configured to decrypt a first and second portion of the message, and the first portion comprises a checksum for verifying the authenticity of the second portion.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente divulgation concerne un système au moins en partie implantable pour injecter une substance dans le corps d'un patient, comprenant : un boîtier conçu pour être implanté à l'intérieur du corps du patient, le boîtier comportant une paroi externe présentant une surface de pénétration ; au moins une aiguille de perfusion disposée dans le boîtier ; et une unité d'entraînement conçue pour déplacer vers l'avant et vers l'arrière ladite au moins une aiguille à perfusion dans des directions opposées, de façon à faire pénétrer l'extrémité de la pointe de ladite au moins une aiguille à perfusion dans ladite zone de pénétration, lors de son déplacement vers l'avant, afin de permettre l'injection de la substance à travers ladite zone de pénétration par l'intermédiaire de ladite au moins une aiguille à perfusion.
PCT/EP2024/054086 2023-02-16 2024-02-16 Système d'administration de médicament WO2024170786A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EPPCT/EP2023/053894 2023-02-16
PCT/EP2023/053894 WO2023156523A1 (fr) 2022-02-18 2023-02-16 Système d'administration de médicament

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010040548A2 (fr) 2008-10-10 2010-04-15 Milux Holding Sa Infusion de médicaments
US20120059349A1 (en) * 2009-02-17 2012-03-08 Pharmanova, Inc. Implantable drug delivery devices
WO2023031062A2 (fr) * 2021-08-30 2023-03-09 Medicaltree Patents Ltd Système d'administration de médicament
WO2023156523A1 (fr) 2022-02-18 2023-08-24 Medicaltree Patents Ltd. Système d'administration de médicament

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010040548A2 (fr) 2008-10-10 2010-04-15 Milux Holding Sa Infusion de médicaments
US20120059349A1 (en) * 2009-02-17 2012-03-08 Pharmanova, Inc. Implantable drug delivery devices
WO2023031062A2 (fr) * 2021-08-30 2023-03-09 Medicaltree Patents Ltd Système d'administration de médicament
WO2023156523A1 (fr) 2022-02-18 2023-08-24 Medicaltree Patents Ltd. Système d'administration de médicament

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ANONYMOUS: "Piezoelectric motor - Wikipedia", 14 January 2024 (2024-01-14), XP093162370, Retrieved from the Internet <URL:https://en.wikipedia.org/w/index.php?title=Piezoelectric_motor&oldid=1195596552> [retrieved on 20240514] *

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