Drug delivery system

Abstract

The present disclosure relates to an at least partly implantable system for injecting a substance into a patient's body, comprising: - 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.

Description

DRUG DELIVERY SYSTEMTechnical field

[0001] 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.Background

[0002] Intestinally implantable drug delivery systems using one or more implantable infusion needles are known, e.g., from WO 2010 / 040548 Al which is particularly designed for the stimulation of penis erection. According to the teaching of WO 2010 / 040548 Al as well as according to the disclosure which will be presented hereinafter, 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. Therefore, 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. More specifically, 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. Instead of one or more pulling wires, 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. Also, 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.

[0003] As set out above, in WO 2010 / 040548 Al as well as according to the present disclosure, 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. However, there is no specific disclosure in WO 2010 / 040548 Al of how the drive unit needs to be configured in order to achieve this. As further set out above, in WO 2010 / 040548 Al as well as according to the present disclosure, 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. In WO 2010 / 040548 Al, this is generally achieved by mounting the infusion needle or needles on a movable carriage, such as a turntable and / or a slide. However, again, there is no specific disclosure in WO 2010 / 040548 Al of how the drive unit needs to be configured in order to achieve this.

[0004] These and other aspects are addressed in the at least partly implantable drug delivery system disclosed in WO 2023 / 156523 Al. The following “aspects”, “new aspects” and “new sub-aspects” are described therein: 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 injection port of the infusion needle, fourth new aspect: a pre-configured elastic opening in the penetration area for penetration by the infusion needle, fifth new aspect: a rounded or beveled injection port of the infusion needle, sixth new aspect: an infusion needle, in particular the curved infusion needle, with a stylet (for which priority is likewise claimed herein from WO 2023 / 156523 Al), further aspect: a coating on the outer surface of the system, even further aspects: various communication aspects.According to one variant, 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. In this context, 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. In another variant, instead of the tip end of the infusion needle or needles penetrating, upon advancement, said penetration area, the tip end is never retracted entirely backwards into the housing or casing. For instance, 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. Also, while 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.Summary

[0005] It is an object of the present disclosure to further improve the system, in particular in view of the safety of the patient.MRT-RESISTANT MOTORS AND PUMPS

[0006] Accordingly, 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. For instance, the motor or motors for driving an injection needle may involve one or more piezoelectric motors, and 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. More particularly, 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 MOTOR

[0007] 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. In particular, piezoelectric motors can be manufactured without magnetic and / or metallic parts. Thus, piezoelectric motors can be made MRI-safe, meaning that the patient can undergo Magnetic Resonance Imaging (MRI) while having the piezo motor implanted.

[0008] According to a first variant, the piezoelectric motor is a piezoelectric inchworm motor. According to a second variant, the piezoelectric motor is a piezoelectric inertial motor. According to a third variant, the piezoelectric motor is a piezoelectric walk -drive motor. According to a fourth variant, the piezoelectric motor is a piezoelectric ultrasonic motor.

[0009] 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.

[0010] 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 piezoelectricultrasonic 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. Although piezoelectric motors have a relatively complex structure and control system, they may feature a linear resolution as low as 0.21 pm.[Oi l] According to one sub-aspect, the piezoelectric motor comprises at least one bimorph piezoelectric actuator.

[0012] The piezoelectric motor according to any one of the variants is preferably substantially nonmagnetic and / or non-metallic.

[0013] In all of the variants, the piezoelectric motor may be a reversible piezoelectric motor.

[0014] The piezoelectric motor may form part of a drive unit for driving the at least one infusion needle.

[0015] 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 needlePIEZOELECTRIC PUMP

[0016] According to one embodiment, a piezoelectric pump is provided 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.

[0017] According to one embodiment, a piezoelectric pump is provided 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.

[0018] According to one embodiment, 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 theinlet 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.

[0019] According to one embodiment, 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.

[0020] According to one embodiment, a piezoelectric pump is provided 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.

[0021] According to one embodiment, a piezoelectric pump is provided 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.

[0022] According to one embodiment, 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.

[0023] According to one embodiment, a piezoelectric pump is provided 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. Theembodiment is advantageous in that the piezoelectric pump is configured to be operated in a double mode.

[0024] According to one embodiment, 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.

[0025] According to one embodiment, 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.

[0026] According to one embodiment, 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.

[0027] According to one embodiment, 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.

[0028] According to one embodiment, 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.

[0029] According to one embodiment, 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, andthe first outlet reservoir and second outlet reservoir are configured to be connected to a single first outlet and single second outlet, respectively.

[0030] According to one embodiment, the drug delivery system further comprises a controller configured to control the piezoelectric pump.

[0031] According to one embodiment, 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.

[0032] 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.FIRST ASPECT - Cross guide with needle cooperating member

[0033] According to a first aspect of the present disclosure, 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. Thus, 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.

[0034] Preferably, 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. To this end, the cross guide may comprise a shaft on which the needle cooperating member is slidably mounted.

[0035] 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.

[0036] Preferably, 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. This way, once the needle cooperating member has been brought in a desired position relative to the cross guide, it may be moved in the advancing and retracting directions of the needle or needles so as to advance or retract the needle or needles. Preferably the arrangement is such that a single needle is advanced or retracted upon movement of the translating frame.

[0037] Where the at least one infusion needle comprises an array of infusion needles, the needle cooperating member is preferably arranged to cooperate with a respective one infusion needle of the array of infusion needles at a time.

[0038] More specifically, 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. To this end, 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. In one embodiment, 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.

[0039] In a particular embodiment, 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. In this case, 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.

[0040] Preferably, 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.

[0041] 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.

[0042] Where the at least one infusion needle comprises only a single infusion needle, 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.

[0043] 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.

[0044] Also, 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.

[0045] Finally, 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.

[0046] 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. Alternatively, 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.

[0047] 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 theneedles 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.

[0048] In all embodiments where 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.

[0049] In all embodiments where a cable is employed, 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.

[0050] While 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.

[0051] As mentioned before, 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.

[0052] In a first embodiment, 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. Preferably, 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. That is, when, after a certain number of injections, the needle cooperating member has been displaced step by step relative to the cross guide so that it has reached a final position, 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.

[0053] It is advantageous when the tensioning spring is designed as a constant-force tensioning spring. This way, 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, isconstant independent of the position of the needle cooperating member relative to the cross guide. For instance, 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. 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. Preferably, 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.

[0054] In a second embodiment, 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. In this case, 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.

[0055] Preferably, the displacement cable or displacement belt is endless. For instance, 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. Then, the needle cooperating member moves in the first and second displacement direction depending on the direction of rotation of the first and second wheels.

[0056] 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.

[0057] 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. However, as mentioned, when the space for implantation is limited and, therefore, the housing must be kept small so that a motor cannot be fitted into the housing, it may be preferable to arrange a drive cable to rotate the first or second wheel, the drive cable accordingly extending out of the housing to a remote motor. In this context, 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.

[0058] Alternatively, 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. In this case, 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.

[0059] In the case where the drive cable is arranged to wind on and off the first or second wheel or on and off 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. In the alternative case where the drive cable is arranged to wind around the first or second wheel or around the third 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.

[0060] In all embodiments, 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.

[0061] In a preferred embodiment, 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. Thus, when the needle cooperating member is moved relative to the cross guide in the displacement direction from one position to the next position, 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.SECOND ASPECT - Translating frame

[0062] According to a second aspect of the present disclosure, 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. Most preferably, 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 movedtogether with the translating frame in the needle advancing and retracting directions. Providing two parallel linear bearings increases the stability and accuracy of the system. The two linear bearings preferably take the form of two parallel shafts to which the translating frame is slidably mounted.

[0063] Further at least one return spring may be arranged to urge the translating frame into a rest position. For instance, 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.

[0064] 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. For example, 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.THIRD ASPECT - Cable with block-and-tackle setup

[0065] According to a third aspect of the present disclosure, 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.

[0066] In the case that the advancement cable is arranged to move the above-mentioned translating frame along the above-mentioned linear bearing or bearings in the advancing and retracting directions, 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. In addition, one end of the advancement cable is either fixed to the housing or to the translating frame. Thus, 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. By providing two first and two second pulleys, the pulling force may be further divided in half once again.FOURTH ASPECT - Combined advancement and displacement cable

[0067] According to a fourth aspect of the present disclosure, 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. For example, 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.

[0068] 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.

[0069] In this case, 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. Thus, when the opposite ends of the advancement and displacement cable are pulled in opposite first and second pulling directions over the same distance, 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. While 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. Again, 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.

[0070] 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 theadvancement and displacement cable, causes the displacement of the at least one infusion needle in the displacement direction.

[0071] In this case, when the system comprises the above-mentioned needle cooperating member to which the at least one infusion needle is attached and the above-mentioned cross guide to which the needle cooperating member is coupled, 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. Thus, when the advancement and displacement cable is pulled in the one or in the other pulling direction, the needle cooperating member is accordingly pulled along the cross guide towards a respective one of the two second pulleys, namely in a displacement direction of the infusion needle or needles.

[0072] In one embodiment, the advancement and displacement cable may comprise two separate cable sections, each cable section having one end thereof connected to the needle cooperating member. However, the advancement and displacement cable may alternatively be continuous with a central portion thereof being fixedly connected to the needle cooperating member.

[0073] As becomes clear from the foregoing, in this fourth aspect, 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.

[0074] In particular, also in this fourth aspect, 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. Again, 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. Also, 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.FIFTH ASPECT - Infusion needle with lateral feeding port

[0075] According to a fifth aspect of the present disclosure, 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. Thus, according to this aspect, the substance to be injected is fed sideways into the needle body. This way, 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.

[0076] In either case, 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. In the case of a plurality of infusion needles, they may be arranged so that 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.

[0077] Preferably, 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. This way, the feeding port is hermetically closed by the material of the septum when the infusion needle is not in use and retracted. Alternatively, 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. Again, in the case of a plurality of infusion needles, each of the infusion needles is arranged in this way, preferably in a side-by-side arrangement.

[0078] Further preferably, also 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. Alternatively, 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.

[0079] As regards a supply lumen for supplying the substance to be injected to the internal reservoir, in the cases where the system comprises the above-mentioned one or more linear bearings and translating frame arranged to move along the linear bearings in the advancing and retracting directions so as to advance and / or retract the infusion needle by respective movement of the translating frame, 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.

[0080] Preferably, in this embodiment as well as in all other embodiments described so far, (also) 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. Thus, 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. Thus, when the infusion needle penetrates 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.

[0081] In all embodiments, the maximum size of the housing is preferably 30 mm x 40 mm x 6 mm.COMMUNICATION ASPECT

[0082] According to a further aspect of the present disclosure, security of the system against fraudulent third-party intervention may be increased. This is particularly important in the context of wireless communication, which can easily be intercepted and then misused by third parties. Accordingly, 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.

[0083] Preferably, 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. Preferably, 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.

[0084] Similarly, as regards the signing of the data transmitted wirelessly by a controller, such as by the aforementioned external controller or remote controller to the internal controller, the signing may involve a private key, whereas subsequent verification of the signed data may involve a corresponding public key.

[0085] Preferably, 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. For the encryption / decryption process, 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.

[0086] As regards the authentication of a user which involves input of authentication data of the patient, the system may comprise a verification unit which is configured to obtain the authentication data of the patient. For instance, 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.

[0087] Alternatively or in addition, the system may comprise a sensation generator for generating a sensation which is detectable by a sense of the patient. In this course, the patient may input into the system authentication data which relate to what the patient has sensed. Then, 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. Again, 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 certaindata or may open a communication channel between two controllers of the system, such as a wireless communication channel.

[0088] In this context, 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.General Communication Housing

[0089] Further, an external device configured for the communication with the implantable medical device when implanted in a patient is provided, 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.

[0090] According to one embodiment, the external device comprises a handheld electronic device.

[0091] According to one embodiment, 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.

[0092] According to one embodiment, 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.

[0093] According to one embodiment, 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 deviceusing 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.

[0094] According to one embodiment, the second communication unit is configured to communicate wirelessly with the implantable medical device using electromagnetic waves at a frequency below 100 kHz.

[0095] According to one embodiment, 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.

[0096] According to one embodiment, 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.

[0097] According to one embodiment, 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.

[0098] According to one embodiment, 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.

[0099] According to one embodiment, 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.

[0100] According to one embodiment, 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.

[0101] According to one embodiment, 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.

[0102] According to one embodiment, 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.

[0103] According to one embodiment, 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.

[0104] According to one embodiment, 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.

[0105] According to one embodiment, 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.

[0106] According to one embodiment, 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.

[0107] According to one embodiment, 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.

[0108] According to one embodiment, 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.

[0109] According to one embodiment, 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.

[0110] According to one embodiment, 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.

[0111] According to one embodiment, 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.

[0112] According to one embodiment, 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.

[0113] According to one embodiment, 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.

[0114] According to one embodiment, 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.

[0115] According to one embodiment, the second communication unit of the housing unit comprises a Bluetooth transceiver.

[0116] According to one embodiment, 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.

[0117] According to one embodiment, 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.

[0118] According to one embodiment, 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.

[0119] According to one embodiment, 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.

[0120] According to one embodiment, 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.

[0121] According to one embodiment, 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. The advantage of the embodiment is that energy is saved by selecting the first communication unit when its range suffices.

[0122] According to one embodiment, 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. The advantage of the embodiment is that energy is saved by selecting the first communication unit when its range suffices.

[0123] According to one embodiment, 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.

[0124] According to one embodiment, 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.

[0125] According to one embodiment, 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.

[0126] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communication received from the display device. The advantage of the embodiment is that the encrypted communication is protected against unwanted third party access.

[0127] According to one embodiment, 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.

[0128] According to one embodiment, 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.

[0129] 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.

[0130] According to one embodiment, 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.

[0131] Further, 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.

[0132] According to one embodiment, the display device is a wearable device or a handset and the housing unit comprises a case for the wearable device or handset.

[0133] According to one embodiment, the first communication unit is a wireless communication unit for wireless communication with the display device.

[0134] According to one embodiment, 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 deviceusing a second communication frequency, wherein the first and second communication frequencies are different.

[0135] According to one embodiment, the housing unit is configured to transmit information pertaining to the display of a user interface to the display device.

[0136] According to one embodiment, the housing unit is configured to receive patient input from the display device.

[0137] According to one embodiment, the housing unit is configured to display a user interface to the patient.

[0138] According to one embodiment, 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.

[0139] According to one embodiment, 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.

[0140] According to one embodiment, 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.

[0141] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communication received from the display device.

[0142] According to one embodiment, the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit.

[0143] According to one embodiment, 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.

[0144] According to one embodiment, 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.

[0145] According to one embodiment, 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.

[0147] According to one embodiment, at least a part of the housing is configured to clasp the display device.

[0148] According to one embodiment, the housing is configured to cover at least one side of the display device when it is mechanically connected to the display device.

[0149] According to one embodiment, 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.General Security Module

[0150] Further, an implantable controller for the implantable medical device is provided. The implantable controller 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.

[0151] According to one embodiment, the security module comprises a set of rules for accepting communication from the central unit.

[0152] According to one embodiment, 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.

[0153] According to one embodiment, 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.

[0154] According to one embodiment, the central unit is configured to verify a digital signature of the received communication from the external device.

[0155] According to one embodiment, 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.

[0156] According to one embodiment, the central unit is configured to verify the size of the received communication from the external device.

[0157] According to one embodiment, 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.

[0158] 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.

[0159] According to one embodiment, 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.

[0160] According to one embodiment, 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.

[0161] According to one embodiment, 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.

[0162] According to one embodiment, 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.

[0163] According to one embodiment, the set of rules comprises a rule related to the rate of data transfer between the central unit and the security module.

[0164] 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.

[0165] 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.

[0166] According to one embodiment, 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.

[0167] According to one embodiment, 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.

[0168] According to one embodiment, 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.

[0169] According to one embodiment, the non-encrypted portion comprises at least a portion of the at least one instruction to the implantable medical device.

[0170] 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.

[0171] The physiological parameter of the patient may comprise at least one of: a temperature, a heart rate and a saturation value.

[0172] 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.

[0173] According to one embodiment, 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.

[0174] According to one embodiment, 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.

[0175] According to one embodiment, 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.

[0176] In any of the preceding embodiments, the implantable controller may comprise at least one crypto-processor.

[0177] The wireless transceiver may in any of the embodiments be configured to receive communication from a handheld external device.

[0178] According to one embodiment, the at least one instruction to the implantable medical device may comprise an instruction for changing an operational state of the implantable medical device.

[0179] 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.

[0180] According to one embodiment, the wireless transceiver is configured to communicate wirelessly with the external device using a first communication protocol, and the central unit is configured to communicate with the security module using a second different communication protocol.

[0181] In any of the embodiments , the wireless transceiver may be configured to communicate wirelessly with the external device using a standard network protocol. The standard network protocolmay 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.

[0182] The wireless transceiver may in some embodiments be configured to communicate wirelessly with the external device using a proprietary network protocol.

[0183] According to one embodiment, the wireless transceiver comprises a UWB transceiver.

[0184] According to one embodiment, the security module and / or the central unit and / or the wireless transceiver are comprised in the controller.

[0185] 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.

[0186] Further, 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.

[0187] According to one embodiment, the controller is configured to vary the variable impedance in response to when the measured parameter exceeds a threshold value.

[0188] According to one embodiment, the measurement unit is configured to measure a parameter related to the energy received by the coil over a time period.

[0189] According to one embodiment, the measurement unit is configured to measure a parameter related to a change in energy received by the coil.

[0190] According to one embodiment, the first switch is placed at a first end portion of the coil, and 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.

[0191] According to one embodiment, the receiving unit is configured to receive transcutaneously transferred energy in pulses according to a pulse pattern, and the measurement unit is configured to measure a parameter related to the pulse pattern.

[0192] According to one embodiment, the controller is configured to control the variable impedance in response to when the pulse pattern deviates from a predefined pulse pattern.

[0193] According to one embodiment, 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.

[0194] According to one embodiment, 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.

[0195] According to one embodiment, the variable impedance comprises a resistor and a capacitor, a resistor and an inductor and / or an inductor and a capacitor.

[0196] The variable impedance may comprise a digitally tuned capacitor. The variable impedance may comprise a digital potentiometer. The variable impedance may comprise a variable inductor.

[0197] According to one embodiment, the variation of the impedance is configured to lower the active power that is received by the receiving unit.

[0198] According to one embodiment, the variable impedance is placed in series with the coil.

[0199] According to one embodiment, the variable impedance is placed parallel to the coil.

[0200] According to one embodiment, 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 - SURFACE COATING

[0201] 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. As is well known, 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 theformation 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.

[0202] In general, 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.

[0203] Thus, 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. However, implants not in contact with flowing blood can still malfunction due to fibrin creation. Here the foreign body reaction may be the underlying factor for the malfunction. Further, the implantation of a foreign body into the human body may cause an inflammatory response. The response generally persists until the foreign body has been encapsulated in a relatively dense layer of fibrotic connective tissue which protects the human body from the foreign body. The process may start with the implant immediately and spontaneously acquiring a layer of host proteins. The blood protein -modified surface enables cells to attach to the surface, enabling monocytes and macrophages to interact on the surfaceof the implant. The macrophages secrete proteins that modulate fibrosis and in turn develop the fibrosis capsule around the foreign body, i.e., the implant. In practice, a fibrosis capsule may be formed of a dense layer of excess fibrous connective tissue. The inelastic properties of the fibrotic capsule may lead to hardening, tightness, deformity, and distortion of the implant, which in severe cases may result in revision surgery.

[0204] 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.

[0205] Thus, according to this further aspect of the present disclosure, in order to mitigate fibrin creation caused by contact between components of the above-discussed implantable system, and the tissue or flowing blood of a patient, 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.

[0206] There may be provided a second coating arranged on the first coating. The second coating may be a different biomaterial than said first coating. In particular, the first coating may comprise a layer of perfluorocarbon chemically attached to the surface and the second coating may comprise a liquid perfluorocarbon layer.

[0207] Further preferably, the surface may comprise a metal, such as at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.

[0208] Finally, 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.FURTHER ASPECT - SECURE INJECTION OF DRUGS

[0209] 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 asystem according to any one of the embodiments disclosed herein, i.e. involving an infusion needle which is advanced into and retracted from the vessel.FIRST SUB-ASPECT - Short distance of needle injection port

[0210] According to a first sub-aspect of this further aspect, as already mentioned previously, the infusion needle may comprise an injection port on a side surface thereof. Preferably, 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. Namely, due to the injection port being 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. In this context, 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.

[0211] Further preferably, 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. This way, the cross-sectional area of the injection port can be kept large while reducing the longitudianl extension of the injection port, thereby ensuring that, upon advancement of the infusion needle into the vessel, the injection port is fully contained in the lumen of the vessel due to the injection port’s short longitudinal extension.

[0212] Accordingly, 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. being provided with an 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.SECOND SUB-ASPECT - Inclined needle

[0213] According to a second sub-aspect of this further aspect, 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. To this end, 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. Then, when the advancing and retraction directions of the at least one infusion needle are arranged in a plane defined by said first direction of the outer surface of the housing’s outer wall and said central axis of the longitudinal vessel and at an inclination angle relative to said first direction, the infusion needle enters, upon advancement, the vessel at such an inclination angle. In other words, 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. In any case, 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°.

[0214] Thus, 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°.

[0215] In particular, in the case where the penetration area has at least one tubular opening for the infusion needle and the infusion needle 11 is liquid-tightly sealed against the at least one tubular opening, as will be described in more detail hereinafter,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°.

[0216] In the case where at least two infusion needles and two penetration area are provided having at least one tubular opening, one for each of the at least two infusion needles, 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.

[0217] 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.

[0218] It is further preferred to provide 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.

[0219] Preferably, 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. In this regard, 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.

[0220] More preferably, 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.

[0221] Accordingly, 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 said penetration area via the at least one infusion needle, wherein the outer wall of the housing may have an outer surface extending in a first direction and configured so that a longitudinal vessel is placeable adjacent said outer surface such that a central axis of the vessel extends in parallel to the first direction, and wherein the advancing and retraction directions of the at least one infusion needle are arranged in a plane defined by said first direction and said longitudinal axis of the vessel and at an inclination angle relative to said first direction, wherein said inclination angle is preferably in a range of 10° and 80°, more preferably in a range of 20° to 40°, wherein the system may further comprise the above-mentioned holder.Curved needle

[0222] According to a further preferred aspect, 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. This provides certain advantages. First, the effect of a curved needle is similar to the effect of the curved surface along which the vessel is placed, asdescribed 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. Accordingly, 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.

[0223] 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.

[0224] Accordingly, 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 infusion needle, which is a section including a tip end of the at least one infusion needle, is curved in a plane of curvature, wherein preferably advancement and retraction of the at least one infusion needle in the advancing and retraction directions comprises rotation of the tip end section of the at least one infusion needle about an axis of rotation which is vertical to the plane of curvature.EVEN FURTHER ASPECT - Needle passing diaphragm

[0225] 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. In this case, when the infusion needle passes through a diaphragm which separates the interior of the housing from the exterior, 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.FIRST SUB-ASPECT - Needle in tube

[0226] According to a first sub-aspect of this even further aspect, 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. This results in 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. Preferably, 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. That is, the sealing surfaces are constituted by these two surfaces. Preferably, the injection port is arranged in this sealing section of the infusion needle. In a preferred embodiment, 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. Rather, 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. Rather, when the needle is advanced to extend out of the tube, any fibrosis inside the tube will be pushed out and any fibrosis in front of the tube will be penetrated by means of the infusion needle.

[0227] Accordingly, 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 a tube, wherein an inner surface of the tube and an outer surface of the at least one infusion needle are liquid-tightly sealed against each other so as to prevent fluid ingress, e.g. blood ingress, through the tube and into the injection port, wherein preferably 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.SECOND SUB-ASPECT - Pre-configured elastic opening

[0228] According to a second sub-aspect of this even further aspect, 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. Thus, external forces are not required to keep the passage closed against ingress of body fluids or ingrowth of fibrosis. Then, when the infusion needle and its injection port are advanced through said pre-configured passage, the needle does not need to pinch a hole into the housing’s wall in order to penetrate it. Rather, the passage is already provided in the wall and needs only to be opened. For instance, 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.

[0229] In a preferred embodiment, the passage has a widened entrance section facing towards the housing. Thus, in the entrance section 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.

[0230] In other embodiments, 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.

[0231] Preferably, 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. In one embodiment, 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.

[0232] Accordingly, 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 through when the infusion needle is being advanced, the passage preferably being configured as a slit having a lengthwise extension and a widthwise extension, wherein a compressor may be provided to act upon opposite sides of the elastic material in opposite directions ofthe slit’s widthwise extension so as to open the passage for the at least one infusion needle when the infusion needle is being advanced.THIRD SUB-ASPECT - Needle injection port with rounded or beveled edge

[0233] According to a third sub-aspect of this even further aspect, there may be provided 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. In other words, 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. Prefereably, 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.

[0234] Accordingly, 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.FOURTH SUB-ASPECT - Needle with stylet

[0235] According to a third sub-aspect of this even further aspect, 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 ofthe 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.

[0236] 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.

[0237] In the advanced position of the stylet, the stylet may even extend from the tip end of the at least one infusion needle. In other words, 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.

[0238] In a general manner, in its retracted position, the stylet 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. For this purpose, 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.

[0239] In the embodiments described so far, the tip end of the infusion needle penetrates, upon advancement of the infusion needle, said penetration area, i.e. membrane, septum, diaphragm, etc. However, 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. For instance, the tip end of the infusion needle may extend from the penetration area when the infusion needle is in its retracted position. In either case, when the infusion needle is advanced from such retracted position into the patient, its tip end will pierce through any fibrosis that may have formed on or in front of the infusion needle. This has the advantage that forces required to piercethrough the penetration area are avoided and thus, any drive for advancing the infusion needle may be dimensioned accordingly smaller.

[0240] For the case where the tip end of the infusion needle extends 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. In the case of a plurality of needles arranged side by side for multiple piercing of the patient, 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.

[0241] Alternatively, where the infusion needle (with its tip end extending from the penetration area in the retracted position) is laterally displaceable for multiple piercing of the patient and wherein the penetration area in the housing’s outer wall comprises a septum through which infusion needle extends, 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.

[0242] Accordingly, 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 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 flow - preferably from the feeding port and - through the hollow body out of the injection port.

[0243] 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. Thus, 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 is advanced, whereas the tip end of the infusion needle may be blunt.Embodiments comprising curved needle with stylet

[0244] In a preferred embodiment, 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.

[0245] 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. This way, 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. Preferably, the conduit is flexible so as to enable the conduit to follow movement of the needle arm.

[0246] Furthermore, 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.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. However, at least for those embodiments where also the tip end of the infusion needle is retracted into the housing when the infusion needle returns to its retracted position, 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.

[0247] 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,

[0248] Preferably, 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 betweendifferent lateral positions. This way, variations of the injection site can be achieved with a single infusion needle. 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.

[0249] Accordingly, 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 to the outer wall by an inclination angle in a range of 10° and 80°, wherein the infusion needle comprises: the 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 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 flow - preferably from the feeding port and - through the hollow body out of the injection port, wherein the system further comprises a needle arm to which the infusion needle is mounted and a stylet arm to which the stylet is mounted, the needle arm and the stylet arm being rotatable about a common axis of rotation.RELEASABLE HOLDER

[0250] 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.

[0251] 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. In addition, 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.

[0252] 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.

[0253] 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.Alternatively, 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. This way, when stylet arm is connected to the needle arm and the needle arm is moved (rotated) so as to advance the infusion needle into the patient’s body by means of the drive unit, and then the stylet arm is released from the needle arm, the needle arm can return to its retracted position, i.e. the stylet moves out of the infusion needle, due to the biasing force of the torsion spring.

[0254] For this purpose, 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.

[0255] In this embodiment in which the drive unit comprises a biasing element and releasable holder, 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 fromthe retracted needle into the housing. While this is 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, at least for those embodiments where also the tip end of the infusion needle is retracted into the housing when the infusion needle returns to its retracted position, 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).CLUTCH

[0256] 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.

[0257] 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, whereas 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. Once the two arms have reached their end position, the drive unit may rotate the two arms in the opposite direction. Depending on the state of the clutch, 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.

[0258] In a preferred embodiment, 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. In this case, 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.

[0259] The at least one biasing element may comprise 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 for their simplicity. Preferably, the torque spring has a square or rectangular cross-section so as to provide maximum force on a minimum of space.

[0260] Preferably, one biasing element may be provided for each of the needle arm and stylet arm. For instance, when the construction is such that rotation of the stylet arm due to the biasing force causes the stylet arm to abut against the needle arm and, consequently, the stylet arm carries the needle arm toward the advanced position, a single biasing element acting on the stylet arm might be sufficient. But 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.

[0261] In this embodiment in which the drive unit comprises a biasing element and a clutch, 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. Thus, there is no danger in this case that residual body fluid drops out from the retracted infusion needle into the inside of the housing, because any such fluid is pushed out of the infusion needle by the stylet before the tip end of the infusion needle reaches the interior of the housing.

[0262] CAM DRIVE

[0263] 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.

[0264] 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, whereas 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. This way, by individually moving the needle crank arm and stylet crank arm, respectively, the positions of the infusion needle and its stylet, respectively, can be determined precisely at any point of time. That is, when the needle crank arm is moved along the needle guide pathway, the needle arm has to follow by rotating about the common axis of rotation. In a similar way, when the stylet crank arm is moved along the stylet guide pathway, the stylet arm has to follow by rotating about the common axis of rotation.

[0265] Now, such movement of the needle crank arm and stylet crank arm, respectively, may be controlled individually in a timely manner. For this purpose, 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. by means of a first cam follower, to the needle cam pathway in such a way that movement of the cam causes the needle arm to rotate about the common axis of rotation, whereas 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.

[0266] Preferably, the at least one cam is in the form of a cam disk which is rotatable about a central axis. Thus, 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. Preferably, 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.

[0267] Preferably, 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. In this case, 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.OTHER ASPECT - POP RIVET

[0268] 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 tissueportion, 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-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the connecting portion and second portion are configured to form a connecting interface between the connecting portion and the second portion, and the second portion extends along a first direction being parallel to the second plane, wherein the second portion has a lengthwise cross-sectional area along the first direction, wherein a second lengthwise cross-sectional area is smaller than a first lengthwise cross-sectional area and wherein the first lengthwise cross-sectional area is located closer to said connecting interface with regard to the first direction.

[0269] In some embodiments, 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.

[0270] In some embodiments, the lengthwise cross-sectional area of the second portion decreases continuously from an end of the intermediate region towards the second end.

[0271] In some embodiments, the lengthwise cross-sectional area of the second portion decreases linearly from an end of the intermediate region towards the second end.

[0272] In some embodiments, the lengthwise cross-sectional area of the second portion decreases stepwise from an end of the intermediate region towards the second end.

[0273] In some embodiments, the distal region of the second portion is conically shaped.

[0274] In some embodiments, the second portion has rotational symmetry along the first direction.

[0275] In some embodiments, the second surface of the second portion is substantially perpendicular to a central extension of the connecting portion.

[0276] In some embodiments, 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.

[0278] In some embodiments, 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.

[0279] In some embodiments, the lengthwise cross-sectional area of the second portion decreases continuously from an end of the intermediate region towards the first end.

[0280] In some embodiments, the lengthwise cross-sectional area of the second portion decreases linearly from an end of the intermediate region towards the first end.

[0281] In some embodiments, the lengthwise cross-sectional area of the second portion decreases stepwise from an end of the intermediate region towards the first end.

[0282] In some embodiments, the proximal region of the second portion is conically shaped.

[0283] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0284] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0285] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0286] In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.

[0287] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.

[0288] In some embodiments, the second portion has said length in a direction being different to a central extension of the connecting portion.

[0289] In some embodiments, the connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0290] In some embodiments, 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.

[0291] In some embodiments, 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.

[0292] In some embodiments, the second direction is parallel to the second plane.

[0293] In some embodiments, 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.

[0294] In some embodiments, the second portion is tapered from the first end to the second end.

[0295] In some embodiments, the second portion is tapered from the intermediate region of the second portion to each of the first end and second end.

[0296] In some embodiments, 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.

[0297] In some embodiments, 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.

[0298] In some embodiments, 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.

[0299] In some embodiments, 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.

[0300] In some embodiments, 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.

[0301] In some embodiments, 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.

[0302] In some embodiments, the distal region is configured to be directed downwards in a standing patient.

[0303] In some embodiments, the first portion has a first height, and 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.

[0304] In some embodiments, 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.

[0305] In some embodiments, 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.

[0306] In some embodiments, 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.

[0307] In some embodiments, 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.

[0308] In some embodiments, the connecting portion comprises a protruding element comprising the fourth cross-sectional area.

[0309] In some embodiments, the first surface is configured to engage the first tissue surface of the first side of the tissue portion.

[0310] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive energy transmitted wirelessly from an external wireless energy transmitter.

[0311] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0312] In some embodiments, the second portion comprises a second wireless energy receiver.

[0313] In some embodiments, the first portion comprises a first energy storage unit.

[0314] In some embodiments, the second portion comprises a second energy storage unit.

[0315] In some embodiments, at least one of the first and second energy storage unit is a solid- state battery.

[0316] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0317] In some embodiments, 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, and 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.

[0318] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0319] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0320] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0321] In some embodiments, 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.

[0322] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0323] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0324] In some embodiments, 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.

[0325] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0326] In some embodiments, 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.

[0327] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0328] In some embodiments, 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.

[0329] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0330] In some embodiments, the second portion comprises at least a portion of an operation device for operating an implantable body engaging portion.

[0331] In some embodiments, the second portion comprises at least one electrical motor.

[0332] In some embodiments, the second portion comprises a transmission configured to reduce the velocity and increase the force of the movement generated by the electrical motor.

[0333] In some embodiments, the transmission is configured to transfer a week force with a high velocity into a stronger force with lower velocity.

[0334] In some embodiments, the transmission is configured to transfer a rotating force into a linear force.

[0335] In some embodiments, the transmission comprises a gear system.

[0336] In some embodiments, 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.

[0337] In some embodiments, 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.

[0338] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0339] In some embodiments, 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.

[0340] In some embodiments, 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.

[0341] In some embodiments, the second portion comprises a force transferring element configured to mechanically transfer force from the second portion to an implanted body engaging portion.

[0342] In some embodiments, the second portion comprises a force transferring element configured to hydraulically transfer force from the second portion to an implanted body engaging portion.

[0343] In some embodiments, 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.

[0344] In some embodiments, the first portion comprises an injection port for injecting fluid into the first portion.

[0345] In some embodiments, the connecting portion comprises a conduit for transferring a fluid from the first portion to the second portion.

[0346] In some embodiments, the conduit is arranged to extend through the hollow portion of the connecting portion.

[0347] In some embodiments, 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.

[0348] In some embodiments, a wall portion of the first chamber is resilient to allow an expansion of the first chamber.

[0349] In some embodiments, 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.

[0350] In some embodiments, 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 piezoelectricpump, and 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.

[0351] In some embodiments, each of the first and second hydraulic systems comprises a reservoir for holding hydraulic fluid.

[0352] In some embodiments, 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.

[0353] In some embodiments, the first surface is configured to engage the first tissue surface of the first side of the tissue portion.

[0354] In some embodiments, the first, second and third planes are parallel to a major extension plane of the tissue.

[0355] In some embodiments, the fourth plane is parallel to a major extension plane of the tissue.

[0356] 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 portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is configured to receive electromagnetic waves at a frequency above a frequency level, and / or to transmit electromagnetic waves at a frequency below the frequency level, wherein the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level, and wherein the frequency level is 100 kHz.

[0357] In some embodiments, wherein the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to the second portion.

[0358] In some embodiments, the first portion is configured to transmit electromagnetic waves at the frequency above the frequency level to an external device.

[0359] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0360] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communication.

[0361] In some embodiments, 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, 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.

[0362] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0363] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0364] In some embodiments, 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.

[0365] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion below the frequency level.

[0366] In some embodiments, the first portion comprises an outer casing made from a polymer material.

[0367] In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.

[0368] In some embodiments, the second portion comprises an outer casing made from titanium.

[0369] In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the second portion must travel through the casing.

[0370] 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 portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level, and wherein the frequency level is 100 kHz.

[0371] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0372] In some embodiments, the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to the second portion.

[0373] In some embodiments, the first portion is configured to transmit electromagnetic waves at the frequency below the frequency level to an external device.

[0374] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0375] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communication.

[0376] In some embodiments, 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.

[0377] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0378] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0379] In some embodiments, 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.

[0380] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion below the frequency level.

[0381] In some embodiments, the first portion comprises an outer casing made from a polymer material.

[0382] In some embodiments, the first portion comprises an outer casing made from titanium.

[0383] In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.

[0384] In some embodiments, the second portion comprises an outer casing made from titanium.

[0385] In some embodiments, the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the second portion must travel through the casing.

[0386] 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 portionhaving 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 portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is made from a polymer material, the second portion comprises a casing made from titanium, wherein the casing forms a complete enclosure.

[0387] In some embodiments, 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.

[0388] In some embodiments, the first portion comprises a casing made from the polymer material.

[0389] In some embodiments, 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.

[0390] In some embodiments, the connecting portion comprises a connection arranged to connect to the first and second portion respectively and carry electrical signals and / or energy.

[0391] In some embodiments, the connection is arranged in a core of the connecting portion such that it is encapsulated by outer material of the connecting portion.

[0392] In some embodiments, the connecting portion comprises a ceramic material.

[0393] In some embodiments, the connection is encapsulated within the ceramic material.

[0394] In some embodiments, the first portion comprises a first connection configured to connect to the connection of the connecting portion.

[0395] In some embodiments, the second portion comprises a second connection configured to connect to the connection of the connection portion.

[0396] In some embodiments, the casing of the second portion is hermetically sealed.

[0397] In some embodiments, the second connection is arranged such that the hermetical seal of the second portion is kept intact.

[0398] In some embodiments, the casing of the first portion is hermetically sealed.

[0399] 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 portion, wherein the connecting portion is configured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, second portion and connecting portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, and wherein the connecting portion is configured to extend between the first portion and the second portion along a central extension axis, and wherein the second portion is configured to extend in a length direction being divergent with the central extension axis, and wherein the connecting portion has a substantially constant cross-sectional area along the central extension axis, or wherein the connecting portion has a decreasing cross-sectional area in a direction from the first portion towards the second portion along the central extension axis, and / or wherein the second portion has a substantially constant cross-sectional area along the length direction, or wherein the second portion has a decreasing cross-sectional area in the length direction.

[0400] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0401] In some embodiments, the connecting portion is tapered in the direction from the first portion towards the second portion along the central extension axis.

[0402] In some embodiments, 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.

[0403] In some embodiments, the second portion is tapered in the length direction.

[0404] In some embodiments, the connecting portion has a circular or oval cross-section in the length direction with a decreasing diameter in the length direction.

[0405] In some embodiments, the length direction extends from an interface between the connecting portion and the second portion towards an end of the second portion.

[0406] In some embodiments, the length direction extends in a direction substantially perpendicular to the central extension axis.

[0407] 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 arrangement configured to enclose the connecting portion so as to prevent fluid from the patient to enter the connecting portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, and the connecting portion comprises a flexible structure enabling the connecting portion to flex.

[0408] In some embodiments, the flexible structure is configured to allow the connecting portion to flex in more than one direction.

[0409] In some embodiments, the flexible structure is configured to allow the connecting portion to flex in all directions.

[0410] In some embodiments, the flexible structure comprises a bellows.

[0411] In some embodiments, the bellows is a metallic bellows.

[0412] In some embodiments, the metallic bellows is welded.

[0413] In some embodiments, the bellows is a titanium bellows.

[0414] In some embodiments, the bellows form part of the hermetic seal arrangement.

[0415] In some embodiments, the flexible structure comprises elevated and lowered portions enabling said flexing of the connecting portion.

[0416] In some embodiments, the elevated and lowered portions are configured to enable the connecting portion to be compressed and / or expanded.

[0417] In some embodiments, the flexible structure has a substantially cylindrical shape.

[0418] In some embodiments, the flexible structure is configured to seal against the first portion and / or the second portion.

[0419] In some embodiments, the connecting portion and the second portion are hermetically sealed from the first portion.

[0420] In some embodiments, 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.

[0421] In some embodiments, 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.

[0422] In some embodiments, the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

[0423] In some embodiments, the second portion comprises a second energy storage unit connected to the second wireless energy receiver.

[0424] In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.

[0425] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0426] In some embodiments, 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, and 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.

[0427] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0428] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0429] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0430] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device,

[0431] 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.

[0432] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0433] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0434] In some embodiments, 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.

[0435] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0436] In some embodiments, 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.

[0437] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0438] In some embodiments, 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.

[0439] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0440] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0441] In some embodiments, 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.

[0442] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0443] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0444] In some embodiments, 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.

[0445] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.

[0446] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0447] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0448] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0449] In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.

[0450] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.

[0451] In some embodiments, 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.

[0452] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0453] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0454] In some embodiments, the gear arrangement comprises a gear system.

[0455] In some embodiments, 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.

[0456] In some embodiments, 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.

[0457] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0458] According to an embodiment of the inventive concept, an implantable energized medical device 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 asecond 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-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, wherein the connecting portion and the second portion are configured to form a unit having a central axis extending from a first end of said unit to a second end of said unit, the first end being proximal to the first portion and the second end being distal to the first portion, wherein a physical footprint of said unit perpendicular to the central axis decreases continuously or stepwise from the first end to the second end of said unit.

[0459] In some embodiments, said physical footprint comprises a cross-sectional area perpendicular to the central axis.

[0460] In some embodiments, 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.

[0461] In some embodiments, said unit comprises an angled section forming a bend in said unit.

[0462] In some embodiments, the bend is between 15° and 165°, such as between 30° and 150°, such as between 45° and 135°, such as substantially 90°.

[0463] In some embodiments, 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.

[0464] In some embodiments, the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

[0465] In some embodiments, the second portion comprises a second energy storage unit connected to the second wireless energy receiver.

[0466] In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.

[0467] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0468] In some embodiments, 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, and 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.

[0469] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0470] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0471] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0472] In some embodiments, 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.

[0473] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0474] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0475] In some embodiments, 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.

[0476] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0477] In some embodiments, 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.

[0478] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0479] In some embodiments, 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.

[0480] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0481] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0482] In some embodiments, 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.

[0483] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0484] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0485] In some embodiments, 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.

[0486] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.

[0487] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0488] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0489] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0490] In some embodiments, 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.

[0492] In some embodiments, 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.

[0493] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0494] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0495] In some embodiments, the gear arrangement comprises a gear system.

[0496] In some embodiments, 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.

[0497] In some embodiments, 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.

[0498] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0499] According to an embodiment of the inventive concept, an implantable energized medical device 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, 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-sectional area is smaller than the first and secondcross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, wherein the connecting portion is configured to extend between the first portion and the second portion along a central extension axis, and wherein the second portion is configured to extend in a length direction being divergent with the central extension axis, and wherein the connecting portion has a decreasing cross-sectional area in a direction from the first portion towards the second portion along the central extension axis, wherein a largest cross-sectional area of the second portion in the length direction is smaller than a smallest cross-sectional area of the connecting portion in said direction from the first portion towards the second portion along the central extension axis, and wherein the second portion further has a decreasing cross-sectional area in the length direction from a first end of the second portion proximal to the connecting portion to a second end of the second portion distal to the connecting portion.

[0500] According to an embodiment of the inventive concept, an implantable energized medical device 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 an electric motor, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, at least part of the electric motor is arranged within the connecting portion.

[0501] In some embodiments, 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.

[0502] In some embodiments, 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.

[0504] In some embodiments, 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.

[0505] In some embodiments, the electric motor is arranged such that its longest dimension extends in a direction between the first portion and the second portion.

[0506] In some embodiments, 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.

[0507] In some embodiments, the electric motor extends through the connecting portion into the first portion and / or the second portion.

[0508] In some embodiments, the electric motor extends through an imaginary boundary defined by the first surface of the first portion extending through the connecting portion.

[0509] In some embodiments, the electric motor extends through an imaginary boundary defined by the second surface of the second portion extending through the connecting portion.

[0510] In some embodiments, 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.

[0511] In some embodiments, 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.

[0512] In some embodiments, 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.

[0513] In some embodiments, 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.

[0515] In some embodiments, the gear arrangement extends through the connecting portion into the first portion and / or the second portion.

[0516] In some embodiments, the gear arrangement extends through an imaginary boundary defined by the first surface of the first portion extending through the connecting portion.

[0517] In some embodiments, the gear arrangement extends through an imaginary boundary defined by the second surface of the second portion extending through the connecting portion.

[0518] In some embodiments, 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.

[0519] In some embodiments, 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.

[0520] In some embodiments, the gear arrangement is a worm drive or comprises a worm drive.

[0521] In some embodiments, 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.

[0522] In some embodiments, the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

[0523] In some embodiments, the second portion comprises a second energy storage unit connected to the second wireless energy receiver.

[0524] In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.

[0525] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0526] In some embodiments, 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, and 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.

[0527] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0528] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0529] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0530] In some embodiments, 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.

[0531] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0532] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0533] In some embodiments, 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.

[0534] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0535] In some embodiments, 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.

[0536] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0537] In some embodiments, 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.

[0538] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0539] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0540] In some embodiments, 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.

[0541] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0542] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0543] In some embodiments, 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.

[0544] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.

[0545] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0546] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0547] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0548] In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.

[0549] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.

[0550] In some embodiments, the gear arrangement is configured to reduce the velocity and increase the force of the movement generated by the electric motor.

[0551] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0552] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0553] In some embodiments, the gear arrangement comprises a gear system.

[0554] In some embodiments, 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.

[0555] In some embodiments, 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.

[0556] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0557] According to an embodiment of the inventive concept, an implantable energized medical device 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 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.

[0558] In some embodiments, 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.

[0559] In some embodiments, the implantable energized medical device further comprises the connecting portion.

[0560] In some embodiments, the connecting portion is integrally formed with the first portion.

[0561] In some embodiments, 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.

[0562] In some embodiments, 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.

[0563] In some embodiments, the first portion is configured to detachably connect, directly or indirectly, to the second portion.

[0564] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy transmitted wirelessly by an external wireless energy transmitter.

[0565] In some embodiments, the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

[0566] In some embodiments, the first energy storage unit is a solid-state battery.

[0567] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0568] In some embodiments, 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.

[0569] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0570] In some embodiments, the first controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0571] In some embodiments, 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.

[0572] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0573] In some embodiments, 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.

[0574] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0575] In some embodiments, 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.

[0576] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0577] A system is provided, the 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 third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; an implantable reservoir configured to hold a fluid; an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured tooperate the implantable pump; wherein the implantable energy storage unit, the implantable reservoir, the implantable pump and the implantable electric motor are arranged externally to the implantable energized medical device.

[0578] A system is provided, the 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 second portion; wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross- sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable reservoir configured to hold a fluid; an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the implantable pump; wherein the implantable reservoir, the implantable pump and the implantable electric motor are arranged externally to the implantable energized medical device.

[0579] A system is provided, the 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 second portion; wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; an implantable reservoir configured to hold a fluid; an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; wherein the implantable electric motor is connected to the implantable energy storage unit, and the implantable electric motor is configured to operate the implantable pump; wherein the implantable energy storage unit, the implantable reservoir and the implantable pump are arranged externally to the implantable energized medical device.

[0580] A system is provided, the 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 arranged in the first portion, the connecting portion or the second portion wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the reservoir and the body engaging implant respectively via a conduit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate theimplantable pump; wherein the implantable energy storage unit, the implantable pump and the implantable electric motor are arranged externally to the implantable energized medical device.

[0581] A system is provided, the 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 be realized as or include a piezoelectric pump, arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; an implantable reservoir configured to hold a fluid; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; wherein the implantable energy storage unit, the implantable reservoir, and the implantable electric motor are arranged externally to the implantable energized medical device.

[0582] A system is provided, the 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 beingconfigured to connect the first portion to the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the body engaging implant; wherein the implantable energy storage unit and the implantable electric motor are arranged externally to the implantable energized medical device.

[0583] A system is provided, the 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 second portion, and - an implantable electric motor arranged in the first portion, the connecting portion or the second portion, the implantable electric motor being connected to the implantable energy storage unit, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable reservoir configured to hold a fluid; and an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; wherein the implantable electric motor is configured to operate the implantable pump; wherein the implantable reservoir and the implantable pump are arranged externally to the implantable energized medical device.

[0584] A system is provided, the system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - afirst 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 connecting portion or the second portion, and - an implantable electric motor arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit, and an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; wherein the implantable electric motor is connected to the implantable energy storage unit and configured to operate the implantable pump; wherein the implantable energy storage unit and the implantable pump are arranged externally to the implantable energized medical device.

[0585] A system is provided, the 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 in the first portion, the connecting portion or the second portion, and - an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, arranged in the first portion, the connecting portion or the secondportion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; and wherein the implantable energy storage unit and the implantable electric motor are arranged externally to the implantable energized medical device.

[0586] A system is provided, the 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 realized as or include a piezoelectric pump, arranged in the first portion, the connecting portion or the second portion, and - an implantable energy storage unit arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross- sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable reservoir configured to hold a fluid; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit wherein the implantable reservoir and the implantable electric motor are arranged externally to the implantable energized medical device.

[0587] A system is provided, the 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 second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit; wherein the implantable electric motor is connected to the implantable energy storage unit, the implantable electric motor being configured to operate the body engaging implant; wherein the implantable energy storage unit is arranged externally to the implantable energized medical device.

[0588] A system is provided, the 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 second portion, - an implantable electric motor arranged in the first portion, the connecting portion or the second portion, the implantable electric motor being connected to the implantable energy storage unit, and - an implantable reservoir configured to hold a fluid, the implantable reservoir being arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectionalarea is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; wherein the implantable electric motor is configured to operate the implantable pump; wherein the implantable pump is arranged externally to the implantable energized medical device.

[0589] A system is provided, the 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 connecting portion or the second portion, - an implantable electric motor arranged in the first portion, the connecting portion or the second portion, and - an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable energy storage unit, and wherein the implantable pump is configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; wherein the implantable electric motor is connected to the implantable energy storage unit and configured to operate the implantable pump; wherein the implantable energy storage unit is arranged externally to the implantable energized medical device.

[0590] A system is provided, the system comprising an implantable energized medical device configured to be held in position by a tissue portion of a patient, the medical device comprising: - afirst 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 in the first portion, the connecting portion or the second portion, - an implantable pump, which may include a piezoelectric motor or may be realized as or include a piezoelectric pump, arranged in the first portion, the connecting portion or the second portion, and - an implantable energy storage unit arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit; and wherein the implantable electric motor is arranged externally to the implantable energized medical device.

[0591] A system is provided, the 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 realized as or include a piezoelectric pump, arranged in the first portion, the connecting portion or the second portion, - an implantable energy storage unit arranged in the firstportion, the connecting portion or the second portion, and - an electric motor arranged in the first portion, the connecting portion or the second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable reservoir configured to hold a fluid; wherein the implantable electric motor is connected to the implantable energy storage unit, the implantable electric motor being configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid to and from the implantable reservoir and the body engaging implant respectively via a conduit wherein the implantable reservoir is arranged externally to the implantable energized medical device.

[0592] A system is provided, the 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 second portion, wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross- sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes; a body engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on body tissue or a body organ; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor being configured to operate the body engaging implant; wherein the implantable electric motor is arranged externally to the implantable energized medical device.

[0593] In some embodiments, the implantable energized medical device further comprises a first wireless communication receiver configured to receive communication signals from outside the patient’s body.

[0594] In some embodiments, 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.

[0595] In some embodiments, 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.

[0596] In some embodiments, 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.

[0597] In some embodiments, 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.

[0598] In some embodiments, 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.

[0599] In some embodiments, the implantable electric motor is operatively connected to the implantable pump via a rotatable shaft.

[0600] In some embodiments, the implantable electric motor is operatively connected to the implantable pump via a magnetic coupling.

[0601] In some embodiments, 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.

[0602] In some embodiments, 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.

[0603] In some embodiments, 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.

[0604] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0605] In some embodiments, 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.

[0606] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0607] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0608] In some embodiments, 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.

[0609] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0610] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0611] In some embodiments, 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.

[0612] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.

[0613] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0614] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0615] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0616] In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.

[0617] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.

[0618] In some embodiments, 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.

[0619] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0620] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0621] In some embodiments, the gear arrangement comprises a gear system.

[0622] In some embodiments, 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.

[0623] In some embodiments, the pump is a hydraulic pump, which hydraulic pump may include a piezoelectric motor or may be realized as or include a piezoelectric pump.

[0624] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0625] According to an embodiment of the inventive concept, an implantable energized medical device 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, and a connecting portion configured tobe 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-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion is configured to be placed subcutaneously in the patient, and wherein the first portion comprises a connecting interface arrangement for transferring wired energy and / or wired communication signals and / or fluid to an additional implant in the patient.

[0626] In some embodiments, 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.

[0627] In some embodiments, the connecting interface arrangement comprises a port for transferring fluid from the first portion to said additional implant.

[0628] In some embodiments, 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.

[0629] In some embodiments, the implantable energized medical device further comprises at least one wire for energy and / or communication signals connected to the connecting interface arrangement.

[0630] In some embodiments, the height of the first portion is a maximum height.

[0631] In some embodiments, 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.

[0632] In some embodiments, the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

[0633] In some embodiments, the second portion comprises a second energy storage unit connected to the second wireless energy receiver.

[0634] In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.

[0635] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0636] In some embodiments, 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, and 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.

[0637] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0638] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0639] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0640] In some embodiments, 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.

[0641] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0642] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0643] In some embodiments, 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.

[0644] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0645] In some embodiments, 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.

[0646] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0647] In some embodiments, 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.

[0648] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0649] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0650] In some embodiments, 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.

[0651] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0652] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0653] In some embodiments, 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.

[0654] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.

[0655] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0656] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0657] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0658] In some embodiments, 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.

[0660] In some embodiments, 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.

[0661] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0662] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0663] In some embodiments, the gear arrangement comprises a gear system.

[0664] In some embodiments, 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.

[0665] In some embodiments, 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.

[0666] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0667] According to an embodiment of the inventive concept, an implantable energized medical device 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, 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-sectional area is smaller than the first and secondcross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion and the second portion are configured to be placed subcutaneously in the patient, such that the implantable energized medical device can be placed with either of the first portion and the second portion on the first side of the tissue portion.

[0668] In some embodiments, 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.

[0669] In some embodiments, 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.

[0670] In some embodiments, 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.

[0671] In some embodiments, 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.

[0672] In some embodiments, 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.

[0673] In some embodiments, 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 secondportion comprises a second wireless energy receiver configured to receive energy transmitted wirelessly by the internal wireless energy transmitter.

[0674] In some embodiments, the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

[0675] In some embodiments, the second portion comprises a second energy storage unit connected to the second wireless energy receiver.

[0676] In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.

[0677] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0678] In some embodiments, 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, and 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.

[0679] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0680] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0681] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0682] In some embodiments, 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.

[0683] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0684] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0685] In some embodiments, 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.

[0686] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0687] In some embodiments, 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.

[0688] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0689] In some embodiments, 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.

[0690] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0691] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0692] In some embodiments, 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.

[0693] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0694] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0695] In some embodiments, 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.

[0697] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0698] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0699] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0700] In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.

[0701] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.

[0702] In some embodiments, 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.

[0703] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0704] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0705] In some embodiments, the gear arrangement comprises a gear system.

[0706] In some embodiments, 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.

[0707] In some embodiments, 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.

[0708] In some embodiments, the hydraulic pump comprises a pump comprising at least one compressible hydraulic reservoir.

[0709] According to an embodiment of the inventive concept, an implantable energized medical device 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, 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 second portion comprises or forms a reservoir for holding a fluid; the implantable energized medical device further comprising: a sealed container configured to protrude into the reservoir; an actuator connected to the sealed container, the actuator being configured to expand or retract the sealed container to change the volume of the sealed container for pumping fluid to or from the reservoir; wherein: the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and second portion are prevented from travelling through the hole in the tissue portion in a direction perpendicular to the first, second and third planes.

[0710] In some embodiments, the actuator comprises an electric motor.

[0711] In some embodiments, the actuator is arranged in the connecting portion.

[0712] In some embodiments, the actuator is partly or fully arranged inside the sealed container.

[0713] In some embodiments, 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.

[0714] In some embodiments, 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.

[0715] In some embodiments, the implantable energized medical device further comprises an injection port for introducing fluid, the injection port being arranged in the first portion.

[0716] In some embodiments, the implantable energized medical device further comprises an internal conduit connecting the injection port to the reservoir.

[0717] In some embodiments, the sealed container is a bellows.

[0718] In some embodiments, the bellows is a metallic bellows.

[0719] In some embodiments, at least a portion of the sealed container configured to be in contact with fluid comprises metal.

[0720] In some embodiments, 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.

[0721] In some embodiments, 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.

[0722] In some embodiments, 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.

[0723] In some embodiments, the implantable energized medical device further comprises a first energy storage unit and / or a second energy storage unit for powering the actuator.

[0724] In some embodiments, 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.

[0725] In some embodiments, the first energy storage unit is connected to the first wireless energy receiver.

[0726] In some embodiments, the second portion comprises the second energy storage unit, wherein the second energy storage unit is connected to the second wireless energy receiver.

[0727] In some embodiments, at least one of the first and second energy storage unit is a solid-state battery.

[0728] In some embodiments, the solid-state battery is a thionyl -chloride battery.

[0729] In some embodiments, 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, and 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.

[0730] In some embodiments, the first portion comprises a first controller comprising at least one processing unit.

[0731] In some embodiments, the second portion comprises a second controller comprising at least one processing unit.

[0732] In some embodiments, the first controller and / or the second controller is configured to control the actuator.

[0733] In some embodiments, at least one of the first and second controller is connected to a wireless transceiver for communicating wirelessly with an external device.

[0734] In some embodiments, 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.

[0735] In some embodiments, the second controller is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

[0736] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0737] In some embodiments, 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.

[0738] In some embodiments, at least one of the coils are embedded in a ceramic material.

[0739] In some embodiments, 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.

[0740] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0741] In some embodiments, 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.

[0742] In some embodiments, the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

[0743] In some embodiments, the first portion is detachably connected to at least one of the second portion and the connecting portion.

[0744] In some embodiments, 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.

[0745] In some embodiments, a connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0746] In some embodiments, a connecting interface between the connecting portion and the first portion is eccentric with respect to the first portion.

[0747] In some embodiments, 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.

[0748] In some embodiments, the first end and second end are separated in a direction parallel to the second plane.

[0749] In some embodiments, the first and second ends comprise an elliptical point respectively.

[0750] In some embodiments, the first and second ends comprise a hemispherical end cap respectively.

[0751] In some embodiments, the second portion has at least one circular cross-section along the length between the first and second end.

[0752] In some embodiments, the second portion has at least one oval cross-section along the length between the first and second end.

[0753] In some embodiments, the second portion has at least one elliptical cross-section along the length between the first and second end.

[0754] In some embodiments, 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.

[0755] In some embodiments, the gear arrangement is configured to transfer a force with a high velocity into a stronger force with lower velocity.

[0756] In some embodiments, the gear arrangement is configured to transfer a rotating force into a linear force.

[0757] In some embodiments, the gear arrangement comprises a gear system.

[0758] In some embodiments, 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.Brief description of the drawings

[0759] The invention is now described, by way of example, with reference to the accompanying drawings, in which: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 U...

Claims

CLAIMSPIEZOELECTRIC MOTOR or PUMP1. An at least partly implantable system for injecting a substance into a patient’s body, comprising: 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 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 system comprises at least one of: at least one piezoelectric motor and at least one piezoelectric pump.PIEZOELECTRIC MOTOR2. The system of claim 1, wherein the at least one piezoelectric motor comprises a piezoelectric inchworm motor.

3. The system of claim 2, wherein the at least one piezoelectric motor comprises a piezoelectric inertial motor.

4. The system of claim 2, wherein the at least one piezoelectric motor comprises a piezoelectric walk-drive motor.

5. The system of to any one of claims 2 to 4, wherein the piezoelectric motor is a linear piezoelectric motor.

6. The system of claim 5, wherein the linear piezoelectric motor operates with at least one of: a speed in a range of 1 mm / s to 10 mm / s, a stroke length in a range of 4 mm - 30 mm, and a force in a range of 2 N - 30 N.

7. The system of to any one of claims 2 to 4, wherein the piezoelectric motor is a rotary piezoelectric motor.

8. The system of claim 7, wherein the rotary piezoelectric motor which operates with at least one of: a rotational speed in a range of 1 mrad / s - 100 mrad / s, and a torque in a range of 100 Nmm - 900 Nmm.

9. The system of claim 2, wherein the at least one piezoelectric motor comprises a piezoelectric ultrasonic motor.

10. The system of claim 9, wherein the piezoelectric ultrasonic motor is a traveling wave ultrasonic motor.

11. The system of claim 9, wherein the piezoelectric ultrasonic motor is a standing wave ultrasonic motor.

12. The system of any one of claims 9 to 11, wherein the piezoelectric ultrasonic motor is a rotary piezoelectric ultrasonic motor which operates with at least one of: a rotational speed in a range of 10 mrad / s - 10,000 mrad / s, and a torque in a range of 20 Nmm - 450 Nmm.

13. The system of any one of claims 9 to 11, wherein the piezoelectric ultrasonic motor is a linear piezoelectric ultrasonic motor which operates with at least one of: a speed in a range of 4 mm / s - 100 mm / s, a stroke length in a range of 4 mm - 30 mm, and a force in a range of 0.5 N - 30 N.

14. The system of any one of claims 2 to 13, wherein the at least one piezoelectric motor comprises at least one bimorph piezoelectric actuator.

15. The system of any one of claims 2 to 14, wherein the at least one piezoelectric motor is substantially non-magnetic.

16. The system of any one of claims 2 to 15, wherein the at least one piezoelectric motor is substantially non-metallic.

17. The system of any one of claims 2 to 16, wherein the at least one piezoelectric motor is a reversible piezoelectric motor.

18. The system of any one of claims 2 to 17, wherein the at least one piezoelectric motor forms part of the drive unit.PIEZOELECTRIC PUMP19. The system of any one of claims 1 to 18, wherein the at least one piezoelectric pump is 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.

20. The system of claim 19, wherein the at least one piezoelectric pump is 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.

21. The system according to claim 19 or 20, wherein the piezoelectric pump comprises a first wall portion, a first diaphragm, a first chamber and a driving element, wherein 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.

22. The system according to claim 21, wherein the inlet of the first wall portion comprises an inlet valve and the outlet of the first wall portion comprises an outlet valve.

23. The system according to claim 22, wherein any of the inlet valve of the first wall portion and outlet valve of the first wall portion is a check valve or an active valve.

24. The system according to claim 23, wherein the check valve is a ball valve.

25. The system according to claim 21, wherein 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.

26. The system according to any one of claims 21 to 23, wherein the first diaphragm comprises a first movable wall portion.

27. The system according to claim 26, wherein the first movable wall portion comprises 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.

28. The system according to claim 27, wherein the first movable wall portion comprises a substantially stiff portion.

29. The system according to any one of claims 26 to 28, wherein the first movable wall portion comprises a bellows.

30. The system according to claim 29, wherein the bellows comprises metal.

31. The system according to claim 30, wherein the bellows comprises at least one of: an oval crosssection, an elliptic cross-section and a circular cross-section.

32. The system according to any one of claims 21 to 31, wherein the piezoelectric pump further comprises: an auxiliary wall portion and an auxiliary chamber sealed from the first chamber, wherein the auxiliary wall portion and the first diaphragm enclose the auxiliary chamber.

33. The system according to any one of claims 21 to 31, wherein the piezoelectric pump 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,wherein the auxiliary wall portion and the auxiliary diaphragm enclose the auxiliary chamber.

34. The system according to claim 32 or 33, wherein the auxiliary chamber is configured to be connected to a pressure adapter enabling variation of pressure in the auxiliary chamber.

35. The system according to claim 34, wherein the pressure adapter comprises an elastic portion having a surface area and wherein the elastic portion is configured to maintain substantially the same surface area while enabling variation of pressure in the auxiliary chamber.

36. The system according to any one of claims 21 to 31, wherein the piezoelectric pump further comprises a second wall portion, a second diaphragm and a second chamber, wherein 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, and the second diaphragm is configured to bend in the same direction as the first diaphragm in response to operation of the driving element.

37. The system according to claim 36, wherein the inlet of the second wall portion comprises an inlet valve and the outlet of the second wall portion comprises an outlet valve.

38. The system according to claim 37, wherein any of the inlet valve of the second wall portion and outlet valve of the second wall portion is a check valve or an active valve.

39. The system according to claim 38, wherein the check valve is a ball valve.

40. The system according to claim 36, wherein 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.

41. The system according to any one of claims 21 to 35, wherein the piezoelectric pump comprises at least two portions connected in series, wherein each portion is a piezoelectric pump according to any one of claims 21 to 35.

42. The system according to any one of claims 36 to 40, wherein the piezoelectric pump comprises at least two portions connected in series, wherein each portion is a piezoelectric pump according to any one of claims 36 to 40.

43. The system according to any one of claims 21 to 35, wherein the piezoelectric pump comprises at least two portions connected in parallel, wherein each portion is a piezoelectric pump according to any one of claims 21 to 35.

44. The system according to any one of claims 36 to 40, wherein the piezoelectric pump comprises at least two portions connected in parallel, wherein each portion is a piezoelectric pump according to any one of claims 36 to 40.

45. The system according to any one of the claims 21 to 44, comprising a controller configured to control the piezoelectric pump.

46. The system according to claim 45, wherein the system further comprises a sensor configured to measure a parameter of the piezoelectric pump, and a feedback unit, wherein: 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, and 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.

47. The system according to claim 46, wherein the parameter of the piezoelectric pump measured by the sensor comprises at least a flow rate or a pressure.INCLINED NEEDLE48. An at least partly implantable system for injecting a substance into a patient’s body, preferably the system of any one of claims 1 to 47, comprising: a housing (12) or casing adapted for implantation inside the patient’s body, the housing (12) or casing having an outer wall with a penetration area (14), at least one infusion needle (11) disposed in the housing (12) or casing so as to penetrate the penetration area (14) 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 (11) when the infusion needle (11) is in the advanced position, and wherein injection of the substance into the patient’s body via the at least one infusion needle (11) is not possible when the infusion needle (11) is in the retracted position, wherein the infusion needle (11) is inclined relative to the outer wall by an inclination angle (a) in a range of 10° and 80°.

49. The system of claim 48, wherein the inclination angle (a) is in a range of 20° to 40°.

50. The system of claim 48 or 49, comprising a drive unit arranged for advancing and retracting the at least one infusion needle in the opposite advancing and retraction directions between the advanced position and the retracted position.

51. The system of any one of claims 48 to 50, wherein the tip end (11C) of the at least one infusion needle (11) penetrates, upon advancement of the at least one infusion needle (11), said penetration area (14).

52. The system of any one of claims 48 to 50, wherein the tip end (11C) of the at least one infusion needle (11) extends from the penetration area (14) when the at least one infusion needle (11) is in its retracted position.

53. The system of claim 52, wherein protection walls (12B) are provided on the housing (12), preferably on opposite sides of the tip end (11C) of the at least one infusion needle (11), so as to prevent the tip end (11C) to get into contact with tissue of the patient when the at least one infusion needle (11) is in its retracted position.

54. The system of claims 52 or 53, wherein the at least one infusion needle (11) is laterally displaceable and wherein the penetration area (14) in the housing’s outer wall comprises a septum through which the at least one infusion needle (11) extends, wherein the septum is movable in a lateral direction along with the at least one infusion needle (11) when the at least one infusion needle (11) is displaced laterally.

55. The system of any one of claims 48 to 54, wherein the outer wall of the housing (12) has an outer surface (12A) extending in a first direction and configured so that a longitudinal vessel (V) is placeable adjacent said outer surface (12A) such that a central axis (Av) of the longitudinal vessel (V) extends in parallel to the first direction, and wherein the advancing and retraction directions of the at least one infusion needle (11) are arranged in a plane defined by said first direction and said central axis (Av) of the longitudinal vessel (V) and at the inclination angle (a) in the a range of 10° and 80° relative to said first direction.

56. The system of claim 55, wherein the first direction changes in a curve along.

57. The system of claim 55 or 56, comprising a holder (20) configured to hold a vessel (V) in position, when the at least one infusion needle (11) is being advanced, such that the central axis (Av) of the vessel (V) extends in parallel to said first direction of the outer surface (12A) of the housing’s outer wall.

58. The system of claim 57, wherein the holder (20) is configured to enclose a section of the longitudinal vessel (V) so that the vessel (V) cannot escape from the holder (20).

59. The system of claim 57 or 58, wherein the holder (20) comprises a movable lid (21) configured to open and close the holder (20) for placing and holding said section of the longitudinal vessel (V) inside the holder (20).CURVED NEEDLE60. The system of any one of claims 48 to 59, wherein at least a tip end section of the at least one infusion needle (11), which is a section including a tip end (11C) of the at least one infusion needle (11), is curved in a plane of curvature.

61. The system of claim 60, wherein advancement and retraction of the at least one infusion needle (11) in the advancing and retraction directions comprises rotation of the tip end section of the atleast one infusion needle (11) about an axis of rotation (1 IE) which is vertical to the plane of curvature.STYLET62. The system of claim 60 or 61, wherein the infusion needle (11) comprises: the tip end (11C) and a hollow body, wherein - preferably - a feeding port (1 ID) is provided in a side wall of the hollow body so as to allow for the substance to be fed through the feeding port (1 ID) into the hollow body and wherein an injection port (11A) is provided in a front side of the tip end (11C) through which the substance is dispensable to the outside of the infusion needle (11), and a stylet (99) which is movable within the hollow body between an advanced position, in which the stylet (99) is so far advanced inside the hollow body that it closes the injection port (11A) so as to prevent fibrosis from growing into the infusion needle (11) when the infusion needle (11) is implanted in a patient, and a retracted position, in which the stylet (99) is 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 (11A).

63. The system of claim 62, wherein, in the advanced position of the stylet (99), the stylet (99) extends from the tip end (11C) of the infusion needle (11).

64. The system of claim 63, wherein a tip end (99C) of the stylet (99) is sharp for piercing through tissue of the patient when the infusion needle (11) is being advanced.

65. The system of claim 64, wherein the tip end (11C) of the infusion needle (11) is blunt.NEEDLE ARM + STYLET ARM / MOVABLE CARRIAGE66. The system of any one of claims 62 to 65, comprising a needle arm (1 IF) to which the infusion needle (11) is mounted and a stylet arm (99F) to which the stylet (99) is mounted, the needle arm (1 IF) and the stylet arm (99F) being rotatable about a common axis of rotation (1 IE).

67. The system of claim 66, comprising a conduit connected to the needle arm (1 IF) for supplying the substance to the infusion needle (11), wherein - preferably - the conduit is flexible so as to enable the conduit to follow movement of the needle arm (1 IF).

68. The system of claim 66 or 67, comprising a drive unit for carrying out the following steps in sequence: advancing the infusion needle (11) and stylet (99) by rotating the needle arm (1 IF) jointly with the stylet arm (99F) about the common axis of rotation (1 IE) in the advancing direction, retracting the stylet (99) inside the infusion needle (11) towards its retracted position by rotating the stylet arm (99F) about the common axis of rotation (1 IE) in the retraction direction, andretracting the infusion needle (11) by rotating the needle arm (1 IF) about the common axis of rotation (1 IE) in the retraction direction.

69. The system of claim 68, wherein the drive unit is configured to carry out the following step before retracting the infusion needle (11): advancing the stylet (99) inside the infusion needle (11) by rotating the stylet arm (99F) about the common axis of rotation (1 IE) in the advancing direction.

70. The system of any one of claims 66 to 69, comprising a first drive shaft (45) extending from the housing (12) or casing, the first drive shaft (45) being configured to rotate the needle arm (1 IF) and the stylet arm (99F) about the common axis of rotation (1 IE).

71. The system of any one of claims 66 to 70, wherein the needle arm (1 IF) and stylet arm (99F) are mounted on a carriage (46) which is movable inside the housing (12) or casing so as to laterally move the tip end (11C) of the at least one infusion needle (11) between different lateral positions.

72. The system of claim 71, comprising a second drive shaft (44) extending from the housing (12) or casing, the second drive shaft (44) being configured to move the carriage (46) inside the housing (12) or casing so as to laterally move the tip end (11C) of the at least one infusion needle (11) between different lateral positions.RELEASABLE HOLDER73. The system of any one of claims 68 to 72, wherein the drive unit comprises: a biasing element (41) providing a biasing force which urges the needle arm (1 IF) and the stylet arm (99F) away from each other, a releasable holder (42) configured to hold the needle arm (1 IF) and stylet arm (99F) close to each other against the biasing force, and a release (43) which is arranged to release the releasable holder (42), when the infusion needle (11) reaches or has reached its advanced position, such that the stylet arm (99F) is moved away from the needle arm (1 IF) due to the biasing force of the biasing element (41).

74. The system of claim 73, wherein the biasing element (41) is a torque spring.

75. The system of claim 74, wherein the torque spring has a square or rectangular cross-section.

76. The system of claim 74 or 75, wherein one end of the torque spring is attached to the stylet arm (99F) and another end of the torque spring is attached to the needle arm (1 IF).

77. The system of claim 74 or 75, wherein one end of the torque spring is attached to the stylet arm (99F) and another end of the torque spring is attached to the housing (12) or casing or, where the needle arm (1 IF) and stylet arm (99F) are mounted on a carriage (46) which is movable inside the housing (12) or casing so as to laterally move the tip end (11C) of the infusion needle (11) between different lateral positions, to the carriage (46).

78. The system of any one of claims 73 to 77, wherein the releasable holder (42) comprises a flexible hook by which the needle arm (1 IF) and stylet arm (99F) are hooked together when the stylet arm (99F) rotates jointly with the needle arm (1 IF) about the common axis of rotation(1 IE) in the advancing direction, and the release (43) is a deflector configured to deflect the flexible hook sideways so as to unhook the flexible hook when the infusion needle (11) reaches or has reached its advanced position.CLUTCH79. The system of any one of claims 68 to 72, wherein the drive unit comprises: at least one biasing element providing a biasing force which urges the stylet arm (99F) jointly with the needle arm (1 IF) about the common axis of rotation (1 IE) either in the advancing direction or in the retraction direction, and a clutch which is configured for selectively connecting the drive unit with at least one of: the stylet arm (99F), the needle arm (1 IF), and both the stylet arm (99F) and needle arm (1 IF).

80. The system of claim 79, wherein the at least one biasing element provides a biasing force which urges the stylet arm (99F) jointly with the needle arm about the common axis of rotation (1 IE) in the advancing direction, and wherein the clutch is configured for selectively connect the drive unit either with the stylet arm (99F), for retracting the stylet (99) inside the infusion needle (11) towards its retracted position by rotating the stylet arm (99F) about the common axis of rotation (1 IE) in the retraction direction, or with either the needle arm (1 IF) or both the needle arm(1 IF) and the stylet arm (99F), for retracting the infusion needle (11) by rotating the needle arm (1 IF) about the common axis of rotation (1 IE) in the retraction direction.

81. The system of claim 80, wherein the at least one biasing element comprises a torque spring.

82. The system of claim 81, wherein the torque spring has a square or rectangular cross-section.

83. The system of any one of claims 80 to 82, wherein a biasing element is provided for each of the needle arm (1 IF) and the stylet arm (99F).CAM DRIVE84. The system of any one of claims 68 to 72, wherein the drive unit comprises: a needle crank arm ( 11G) connected with one end thereof to the needle arm ( 1 IF) and with another end thereof to a needle guide pathway (11H) such that movement of the needle crank arm (11G) along the needle guide pathway (11H) and rotation of the needle arm (1 IF) about the common axis of rotation (1 IE) are interdependent, a stylet crank arm (99G) connected with one end thereof to the stylet arm (99F) and with another end thereof to a stylet guide pathway (99H) such that movement of the stylet crank arm(99G) along the stylet guide pathway (99H) and rotation of the stylet arm (99F) about the common axis of rotation (1 IE) are interdependent.

85. The system of claim 84, wherein the drive unit further comprises at least one cam comprising a needle cam pathway (11J) and a stylet cam pathway (99 J), wherein the needle crank arm (11G) is connected to the needle cam pathway (11J) in such a way that movement of the cam causes the needle arm (1 IF) to rotate about the common axis of rotation (HE), and a stylet crank arm (99G) is connected to the stylet cam pathway (99J) in such a way that rotation of the cam causes the stylet arm (99F) to rotate about the common axis of rotation (1 IE).

86. The system of claim 85, wherein the at least one cam is a cam disk (49) which is rotatable about a central axis.

87. The system of claim 86, wherein, where the needle arm (1 IF) and stylet arm (99F) are mounted on a carriage (46) which is movable inside the housing (12) or casing so as to laterally move the tip end (11C) of the infusion needle (11) between different lateral positions, the carriage (46) is rotatably mounted inside the housing (12) or casing.IMPLANTATION88. A method of implanting at least one component of the system for injecting a substance into a patient’s body according to any one of claims 1 to 87, comprising the steps of: cutting the skin, dissecting free at least one area within the patient’s body, placing the housing accommodating the at least one infusion needle within said dissected area such that the tip end of the at least one infusion needle, when penetrating the housing's outer wall, can penetrate the patient’s tissue so as to allow for injecting a substance through said at least one penetration area via the at least one infusion needle, and closing at least the skin after implantation of at least parts of the system.

89. The method of claim 88, further comprising the step of placing one or more of the following components of the system within the patient’s body remote from the housing accommodating the at least one infusion needle: at least part of the drive unit (D), a reservoir, a pump (P), at least one motor (M, M2) for actuation of one or more elements of the drive unit, the pump (P) or any other energy-consuming part of the system, energy storage means (A) for providing the at least one motor with energy, galvanic coupling elements between either an external energy source (E) or the energy storage means (A) and the motor (M, M2) for transmitting energy to the motor in contacting fashion,wireless coupling elements adapted to connect either the motor (M, M2) or the energy storage means (A) or both to an extracorporeal primary energy source for transmitting energy to either the motor or the energy storage means or both in non-contacting fashion, a control unit (Cl) for controlling the motor (M, M2), a data transmission interface for wirelessly transmitting data from an external data processing device (C2) to the control unit (Cl), a feedback sensor (F), wireless energy transforming means, an injection port for refdling the reservoir (Rl), and at least one tube for injecting thereinto a substance to be injected by means of the at least one injection needle.CROSS GUIDE90. The system of any one of claims 1 to 87, comprising a needle cooperating member (13; 113; 213; 713) arranged to cooperate with the at least one infusion needle (11) upon the advancing or retracting of the at least one infusion needle (11) and further comprising a cross guide (15; 115; 215; 715) to which the needle cooperating member (13; 113; 213; 713) is coupled so as to be movable into different positions in a displacement direction which is different from the advancing and retracting directions.TRANSLATING FRAME91. The system of any one of claims 1 to 87, comprising two linear bearings (102) arranged in parallel and a translating frame (103) connecting the two linear bearings (102) and arranged to move along the two linear bearings (102) in the advancing and retracting directions of the at least one infusion needle (11) so as to advance or retract or both advance and retract the at least one infusion needle (11) by movement of the translating frame (103).BLOCK-AND-TACKLE SETUP92. The system of any one of claims 1 to 87, wherein the drive unit (100; 200; 700) comprises an advancement cable (130; 230; 730), wherein pulling the advancement cable (130; 230; 730) causes the advancing or retracting of the at least one infusion needle (11), wherein the advancement cable (130; 230; 730) forms part of a block-and-tackle setup.COMBINED ADVANCEMENT AND DISPLACEMENT CABLE93. The system of any one of claims 1 to 87, wherein the drive unit (200) comprises a combined advancement and displacement cable (230) which is arranged so that pulling the advancement and displacement cable (230) allows for both causing the advancing or retracting of the at leastone infusion needle (11) and causing displacement of the at least one infusion needle (11) in a displacement direction which is different from the advancing and retracting directions.NEEDLE WITH LATERAL FEEDING PORT94. The system of any one of claims 1 to 87, wherein the at least one infusion needle (11) has a tubular needle body with a tip end (11C), an injection port (11 A) arranged at the tip end ( 11C) so as to allow for injecting the substance via the at least one infusion needle (11), a feeding port (1 ID) arranged distant from the tip end (11C) so as to allow for receiving the substance to be injected and a needle lumen inside the tubular needle body connecting the injection port (11A) with the feeding port (1 ID), wherein the feeding port (1 ID) is a side port which is arranged on a side of the tubular needle body.SHORT DISTANCE OF NEEDLE INJECTION PORT95. The system of any one of claims 1 to 87, wherein an injection port (11A) is provided on a side surface of the at least one infusion needle (11), said injection port (11A) being spaced apart from the tip end (11C) of the at least one infusion needle (11) by less than 2 mm.NEEDLE IN TUBE96. The system of any one of claims 1 to 87, wherein an injection port (11A) is provided on a side surface of the at least one infusion needle (11) and wherein, when the at least one infusion needle (11) is in a retracted position, the tip end (11C) of the at least one infusion needle (11) is arranged in a tube, wherein an inner surface of the tube and an outer surface of the at least one infusion needle (11) are liquid-tightly sealed against each other so as to prevent fluid ingress through the tube and into the injection port (11A).PRECONFIGURED ELASTIC OPENING97. The system of any one of claims 1 to 87, wherein said penetration area (14) is at least partly made of an elastic material in which a passage (14A) is pre -configured for the at least one infusion needle (11) to pass through, said passage (14A) being normally closed by resilient forces that are generated by the elasticity of the elastic material.ROUNDED OR BEVELED NEEDLE INJECTION PORT98. The system of any one of claims 1 to 87, wherein an injection port (11A) is provided on a side surface of the at least one infusion needle (11), said injection port (11A) having a rounded or beveled edge at a transition between the injection port (11A) and the side surface.NEEDLE WITH STYLET99. The system of any one of claims 1 to 87, wherein the infusion needle (11) comprises:a tip end (11C) and a hollow body, wherein an injection port (11A) is provided in a front side of the tip end (11 C) through which the substance is dispensable to the outside of the infusion needle (11), and a stylet (99) which is movable within the hollow body between an advanced position, in which the stylet (99) is so far advanced inside the hollow body that it closes the injection port (11A) so as to prevent fibrosis from growing into the infusion needle (11) when the infusion needle (11) is implanted in a patient, and a retracted position, in which the stylet (99) is 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 (11A).

Images