Drug Delivery Systems

Abstract

The present invention provides an at least partially implantable system for injecting a substance into a patient's body, comprising: a housing for implantation within the patient's body, the housing having an outer wall with a penetration portion; at least one infusion needle disposed within the housing; and a drive unit arranged to advance and retract the at least one infusion needle in opposite directions such that, upon advancement of the at least one infusion needle, a tip of the at least one infusion needle penetrates the penetration portion and a substance can be injected through the penetration portion via the at least one infusion needle.

Description

[Technical Field]

[0001] The invention relates generally to an at least partially implantable drug delivery system, and the present disclosure particularly relates to a system for injecting a substance into a patient's body, and to methods of using and implanting the system, for injecting a substance, particularly a drug, into a patient's body, particularly into the patient's blood circulatory system, or to stimulate penile erection. [Background technology]

[0002] An intestinal implantable drug delivery system using one or more implantable infusion needles is known, for example, from WO 2010 / 040548 A1, which is specifically designed for stimulating penile erection.

[0003] According to the teachings of WO 2010 / 040548 A1 and the disclosure provided below, an infusion needle is movably positioned within a housing so that its tip can advance to penetrate a septum, such as a silicone membrane, provided on the outer wall of the housing. Positioning the infusion needle within the housing can prevent fibrosis from developing within the infusion needle. However, frequent penetration into the same body site can cause inflammation, eventually making further penetrations difficult or even impossible. Therefore, multiple infusion needles, or a single laterally displaceable infusion needle, can be provided to penetrate the outer wall of the housing at different penetration sites. This allows for varying the infusion site, penetrating different infusion sites at different times, thereby allowing the body tissue time to recover from penetration by the infusion needle. A drive unit is provided for advancing and retracting the infusion needle or needles and for laterally displacing the infusion needle or needles as appropriate. A portion of the drive unit may be provided for implantation at a location remote from the infusion area and may consist of a pull wire guided within a sheath so that pulling the distal end of the wire causes lateral movement of the infusion needle. More specifically, pulling the wire laterally displaces the infusion needle or needle tip from the first insertion site to the second insertion site. A single pull wire may be sufficient to cause the infusion needle to move laterally in one direction, while a spring element urges the infusion needle back to its starting position, or two pull wires may be provided to move the infusion needle back and forth laterally. Additional pull wires may be provided to advance and retract the infusion needle, again with spring elements to urge the infusion needle back to its starting position. Instead of multiple pull wires, the drive mechanism may consist of one or more rotating shafts, the ends of which are provided with worm screws that cooperate with gears to advance and / or retract the infusion needle and / or laterally move the distal end of the infusion needle. The rotating shafts are flexible and guided within a sheath to transfer kinetic energy from a remote location to the implantable infusion device.The system may further include one or more electric motors located inside and / or outside the housing for driving a drive unit or part of the drive unit, such as the wires / wires or drive shaft / shafts, and may further include at least one reservoir adapted for implantation in a patient's body and in fluid communication with the infusion needle or needles for supplying the infusion needle with a substance to be injected. A pump, also adapted for implantation in a patient's body, may be provided for delivering the substance from the reservoir to the infusion or injection needle. Summary of the Invention

[0004] As noted above, in WO 2010 / 040548 A1 and the present disclosure, the drive unit is configured to advance and retract the infusion needle. In WO 2010 / 040548 A1, this is generally achieved by slidably mounting the infusion needle and biasing it back to a resting position with a return spring. However, WO 2010 / 040548 A1 does not specifically disclose how the drive device must be configured to achieve this. As further noted above, in WO 2010 / 040548 A1 and according to the present disclosure, the drive unit is configured to laterally displace the distal end of the infusion needle to different insertion sites or to actuate different ones of multiple infusion needles. In WO 2010 / 040548 A1, this is generally achieved by mounting the infusion needle or needles on a movable carriage, such as a turntable and / or slide. However, again, WO2010 / 040548A1 does not provide any specific disclosure as to how the drive unit should be configured to achieve this.

[0005] These and other aspects are addressed, at least in part, in the implantable drug delivery system disclosed in WO2023 / 156523A1. 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 translation frame for advancing and retracting the injection needle; Third aspect: Cable-driven injection needle with cable block-and-tackle setup; Fourth aspect: Fourth aspect: Cable-driven injection needle with combined advancement and displacement cable; Fifth embodiment: An injection needle provided with a side port for supplying injection fluid to the injection needle; First new aspect: a short distance from the lateral needle port to the tip of the needle; Second new aspect: an inclined arrangement of infusion needles, in particular curved infusion needles (as a sub-aspect in which priority is claimed herein from WO2023 / 156523A1); Third new aspect: placement of the infusion needle within a tube that provides a fluid-tight seal to the infusion needle's inlet; Fourth new aspect: a pre-set elastic opening in the penetration part for the infusion needle to penetrate; Fifth new aspect: rounded or beveled injection port of infusion needle; Sixth new aspect: an infusion needle with a stylet, in particular a curved infusion needle (priority is also claimed from WO 2023 / 156523 A1); Further aspects: a coating on the exterior surface of the system; Further aspects: various communication aspects.

[0006] According to one variant, the tip of the infusion needle is such that, when advanced, its tip end penetrates said piercing area, allowing the injection of a substance through the needle or through the piercing area via the needle.

[0007] In this context, the penetration of the penetration portion by the tip as the infusion needle advances does not necessarily mean that the tip is located inside the housing, spaced from the inner side of the outer wall of the housing or casing, prior to such advancement. Rather, the infusion needle may even penetrate the wall so that its tip extends into the outer wall prior to its advancement and extends from the outer surface of the wall upon advancement. This is at least an option in embodiments in which the infusion needle is not laterally displaced during successive infusion cycles.

[0008] In another variation, instead of the distal end of the infusion needle or needle penetrating said penetration portion when advanced, the distal end does not retract completely rearward into the housing or casing, for example, when the infusion needle or needle is / are in the retracted position, the distal end of the infusion needle or needle may extend from the penetration area.

[0009] The pierceable area may also preferably be formed from a membrane made of a material that can be easily penetrated by an injection needle, in particular an elastomeric polymer material such as silicone, although in some cases the pierceable area may simply be a hole in the wall that allows the needle to be advanced from inside the housing or casing to its outside.

[0010] overview An object of the present disclosure is to further improve the system, particularly from the patient safety aspect.

[0011] MRT-resistant motors and pumps Thus, the motor or at least one of the motors of an at least partially implantable system for injecting a substance into a patient's body may be a piezoelectric motor, and / or the pump or at least one of the pumps of such a system may be a piezoelectric pump. For example, a motor or motors for driving an injection needle may include one or more piezoelectric motors, and a pump or pumps for delivering infusion fluids to a patient may include one or more piezoelectric motors for driving the pump or pumps, or may include one or more piezoelectric pumps. More specifically, the motors and pumps of the at least partially implantable systems for injecting a substance into a patient's body disclosed in WO 2010 / 040548 A1 and WO 2023 / 156523 A1 may include one or more piezoelectric motors and / or one or more piezoelectric pumps.

[0012] Piezoelectric motor Piezoelectric motors are advantageous in that they have high precision, consume low power, can be small and lightweight, provide high movement accuracy, and can be made from materials that are relatively immune to interference, such as electromagnetic interference. In particular, piezoelectric motors can be manufactured without the use of magnetic and / or metallic components. Piezoelectric motors can therefore be MRI-safe, i.e., allow a patient to undergo magnetic resonance imaging (MRI) with a piezoelectric motor implanted.

[0013] According to a first variant, the piezoelectric motor is a piezoelectric inchworm motor. According to a second variant, the piezoelectric motor is a piezoelectric inertia 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.

[0014] The piezoelectric motor may be a linear piezoelectric motor operating at at least one of a speed in the range of 1 mm / s to 10 mm / s, a stroke length in the range of 4 mm to 30 mm, and a force in the range of 2 N to 30 N, or the piezoelectric motor may be a rotary piezoelectric motor operating at at least one of a rotational speed in the range of 1 mrad / s to 100 mrad / s, and a torque in the range of 100 Nmm to 900 Nmm.

[0015] The piezoelectric ultrasonic motor may be a linear piezoelectric ultrasonic motor, or a rotary piezoelectric ultrasonic motor operating at a speed ranging from 4 mm / s to 100 mm / s, a stroke length ranging from 4 mm to 30 mm, and a force ranging from 0.006 N to 40 N, or a rotational speed ranging from 10 mrad / s to 10,000 mrad / s, and a torque ranging from 20 Nmm to 450 Nmm. Piezoelectric motors have relatively complex structures and control systems, but can feature a low linear resolution of 0.21 μm.

[0016] According to one sub-embodiment, the piezoelectric motor comprises at least one bimorph piezoelectric actuator.

[0017] The piezoelectric motor according to any one of the variations is preferably substantially non-magnetic and / or non-metallic.

[0018] In all variants, the piezoelectric motor may be a reversible piezoelectric motor.

[0019] The piezoelectric motor may form part of a drive unit for driving at least one infusion needle.

[0020] The piezoelectric motor may be configured to drive a pump for injecting a substance into a patient's body through at least one infusion needle. Piezoelectric Pump

[0021] According to one embodiment, a piezoelectric pump is provided, comprising a first wall, a first diaphragm, a first chamber, and a drive element. The first diaphragm and the first wall enclose the first chamber. The first wall 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 a drive element, and the drive element comprises a piezoelectric actuator or is configured to be operated by a piezoelectric motor. The piezoelectric pump is advantageous in that it is a miniaturized, energy-efficient implantable device. The piezoelectric pump can accurately pump fluid at flow rates ranging from 0.01 ml / min to 35 ml / min and pressures ranging from 0.2 kPa to 36 kPa.

[0022] According to one embodiment, a piezoelectric pump is provided in which the inlet of the first wall portion constitutes an inlet valve and the outlet of the first wall portion constitutes an outlet valve. Either the inlet valve of the first wall portion or the 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 the outlet valve are useful for stabilizing the flow rate in the first chamber.

[0023] According to one embodiment, the inlet of the first wall comprises an inlet static element and the outlet of the first wall comprises an outlet static element, either of which is configured to function as a nozzle or a diffuser. Nozzles and diffusers are advantageous in that they are more resistant to wear and fatigue failure than check valves and active valves.

[0024] According to one embodiment, the first diaphragm includes a first movable wall portion. The first movable wall portion may be comprised of an elevating portion, which allows for at least one of compression and expansion to move the first movable wall portion. The first movable wall portion may be comprised of a substantially rigid portion. The first movable wall portion may be comprised of a bellows. The bellows may be comprised of metal. The bellows may be comprised of at least one of an elliptical cross section, an elliptical cross section, and a circular cross section. Metal is advantageous because it is generally dense and fluids do not easily diffuse through metal. This reduces the risk of fluid diffusing from or into the first chamber.

[0025] According to one embodiment, a piezoelectric pump is provided, further comprising an auxiliary wall and an auxiliary chamber sealed from the first chamber. The auxiliary wall and the first diaphragm enclose the auxiliary chamber. Having the auxiliary chamber sealed from the first chamber is advantageous in that components not suitable for contact with the fluid in the first chamber can be housed in the auxiliary chamber. Such components may be drive elements.

[0026] According to one embodiment, there is provided a piezoelectric pump further comprising an auxiliary wall, 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 drive element, the auxiliary wall and the auxiliary diaphragm enclosing the auxiliary chamber.

[0027] According to one embodiment, the auxiliary chamber is configured to be connected to a pressure adapter that can vary the pressure within the auxiliary chamber. The pressure adapter may be comprised of an elastic portion having a surface area, and the elastic portion may be configured to allow for variations in pressure within the auxiliary chamber while maintaining substantially the same surface area. This is advantageous in that fibrous tissue at least partially covering the elastic portion may easily conform to the elastic portion.

[0028] According to one embodiment, a piezoelectric pump is provided, further comprising a second wall, a second diaphragm, and a second chamber. The second diaphragm and the second wall enclose the second chamber. The second wall 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 drive element. Advantageously, this embodiment allows the piezoelectric pump to operate in a dual mode.

[0029] According to one embodiment, the inlet of the second wall comprises an inlet valve, and the outlet of the second wall comprises an outlet valve. Either the inlet valve of the second wall or the outlet valve of the second wall may be a check valve or an activated valve. The check valve may be a ball valve. The inlet valve and the outlet valve are useful for stabilizing the flow rate in the second chamber.

[0030] According to one embodiment, the inlet of the second wall comprises an inlet stationary element and the outlet of the second wall comprises an outlet stationary element, either of which is configured to function as a nozzle or a diffuser. Nozzles and diffusers are advantageous in that they are more resistant to wear and fatigue failure than check valves and active valves.

[0031] According to one embodiment, the piezoelectric pump comprises at least two sections connected in series, each section being a piezoelectric pump. The series connection allows for greater pressure compared to piezoelectric pumps in which fluid is transferred from an inlet to an outlet reservoir through a single chamber.

[0032] According to one embodiment, the piezoelectric pump comprises at least two sections connected in series, each section configured to operate in a double mode, where the series connection allows for greater pressure than a piezoelectric pump configured to operate 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.

[0033] According to one embodiment, the piezoelectric pump comprises at least two sections connected in parallel, each section being a piezoelectric pump, the parallel connection allowing for a higher flow rate compared to a piezoelectric pump configured with an inlet reservoir connected to a single inlet and an outlet reservoir connected to a single outlet.

[0034] According to one embodiment, the piezoelectric pump comprises at least two sections connected in parallel, each section being a piezoelectric pump configured to operate in double mode, the parallel connection allowing for a higher flow rate compared to a piezoelectric pump configured to operate in double mode, in which the first inlet reservoir and the second inlet reservoir are connected to a single first inlet and a single second inlet, respectively, and the first outlet reservoir and the second outlet reservoir are connected to a single first outlet and a single second outlet, respectively.

[0035] According to one embodiment, the drug delivery system further comprises a controller configured to control the piezoelectric pump.

[0036] 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 an adjustment 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 control of the piezoelectric pump based on the conditioning signal received from the feedback unit so that the measured parameter achieves the set value.

[0037] A piezoelectric pump may be provided for injecting a substance into the patient's body through the at least one infusion needle when the infusion needle is in the advanced position.

[0038] First embodiment - Cross guide (with needle cooperating member) According to a first aspect of the present disclosure, the system may further include a needle cooperating member arranged to cooperate with the at least one infusion needle during advancement or retraction of the at least one infusion needle, and a cross guide to which the needle cooperating member is coupled so as to be movable to different positions in a displacement direction different from the advancement direction and the retraction direction, so that advancement or retraction of the infusion needle may be accompanied by a prior lateral displacement of the needle cooperating member along the cross guide to a different injection site position.

[0039] Preferably, the cross guide is fixedly held between two opposed fixed points to provide a structure that is rigid enough to ensure proper alignment of the needle cooperating member with respect to the injection site, regardless of the position of the needle cooperating member 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.

[0040] The cross guide preferably extends in a displacement direction perpendicular to the direction of advancement and retraction of the needle or acupuncture needle, but may also extend in a direction oblique to the direction of advancement and retraction of the needle or acupuncture needle if the space required for implanting the housing in the patient's body so requires.

[0041] Preferably, the system comprises a translation frame arranged to move in the needle or needles' advance and retract directions, the cross guide being fixed to the translation frame for movement therewith. In this way, once the needle cooperating member has been motorized into a desired position relative to the cross guide, it can be moved in the needle or needles' advance and retract directions 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 translation frame.

[0042] If the at least one infusion needle comprises an array of infusion needles, the needle cooperating member is preferably arranged to cooperate with each one infusion needle of the array of infusion needles at a time.

[0043] More specifically, the needle cooperating member can be arranged to act on the array of infusion needles to advance or retract each one of the infusion needles depending on its position relative to the cross guide. For this purpose, the needle cooperating member can be separated from the array of infusion needles. That is, in the rest position, the needle cooperating member can be spaced apart from the infusion needles and can engage each one of the infusion needles upon movement of the translation frame. In one embodiment, the infusion needles of the array of infusion needles can be mounted on the mounting block so as to be slidable in the forward and retracted directions, and the needle cooperating member is preferably arranged to advance each one of the infusion needles by pushing in the forward direction.

[0044] In a particular embodiment, the needle cooperating member may consist of a needle driver and a positioner, which are arranged to disengage from each other when the translation frame moves in the forward direction. In this case, a secondary cross guide member may be arranged parallel to the cross guide, the positioner being movably, preferably slidably, mounted on the main secondary cross guide member and the needle driver being movably, preferably slidably, mounted on the (main) cross guide.

[0045] Preferably, the arrangement is such that when the positioning component and the needle drive component are engaged, the positioning component is moved in the displacement direction along the secondary cross guide member, thereby moving the needle drive component also in the displacement direction along the primary cross guide to a desired position, and when the needle drive unit is positioned, the engagement between the needle drive unit and the positioning component is released and the needle drive unit can be moved in the forward or backward direction so that it cooperates with a respective one of the infusion needles in the array of infusion needles.

[0046] A displacement cable, which will be described in more detail below, is provided for pulling the needle cooperating member in the direction of displacement along the cross guide and may be connected to the positioning portion of the needle cooperating member.

[0047] If 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, and the single infusion needle may be welded or potted to the needle cooperating member so as to hold the infusion needle securely in place.

[0048] The single infusion needle may have a curved portion attached to the needle cooperating member, which may facilitate correct positioning of the infusion needle on the needle cooperating member when assembling the system. More specifically, the curved portion may be fixedly held in a corresponding curved recess in the needle cooperating member. The curved recess provides a counter force to the force acting on the needle when the needle is advanced with its front end through the penetration region in the wall of the housing.

[0049] A needle stiffening tube may also be placed around the single infusion needle to minimize deflection of the infusion needle as it passes through the penetration in the wall of the housing.

[0050] Finally, the tubing for supplying the substance to be injected through the single infusion needle is connected to the end of the single infusion needle and can be looped inside the housing to allow the necessary range of motion of the tubing.

[0051] At least one motor, in particular a piezoelectric motor, may be provided, for example 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 needle or needle cooperating member in a different lateral displacement direction, or two motors may be provided which cooperate to advance and / or retract the needle or needles in opposite advancing and retracting directions and to displace the needle or needle or needle cooperating member in a different lateral displacement direction.

[0052] The motor or motors can be located within a housing in which the needle or needles are located. However, depending on the space available for implanting the housing within the patient's body, it may be desirable to keep the housing small. In this case, one or more pull cables can be provided within the housing from one or more motors located remotely within or outside the patient's body to transfer kinetic energy into the housing for moving the needle or acupuncture needles located within the housing. One or more cables or belts can also be provided within the housing to transfer energy between components located within the housing.

[0053] In all embodiments in which a motor or cable is arranged to advance the infusion needle or needles in a forward direction and resilient means, e.g., a spring element, is provided to bias the needle or needles back to a rest position, the arrangement may equally be reversed, such that the motor or cable is arranged to retract the infusion needle or needles to a rest position and resilient means, e.g., a spring element, is provided to advance the needle or needles to an actuated position.

[0054] In all embodiments where a cable is employed, the cable is preferably a Bowden cable so that it can transmit tensile forces while being flexible, which is particularly advantageous when part of the drive is remote from the housing and the cable runs into the housing from a remotely located motor, particularly a piezoelectric motor.

[0055] Although a cable is typically understood to consist of a set of coated wires, a cable within the meaning of this disclosure may also consist of 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 set of coated wires. The wires are preferably metallic, but may alternatively be made of or consist of one or more polymer wires.

[0056] As previously mentioned, the system may consist of a displacement cable or a displacement belt for pulling the needle cooperating member in a displacement direction along the cross guide.

[0057] In a first embodiment, a tension spring may be arranged to provide a counter force that counteracts the tension of the displacement cable acting on the needle cooperating member. The tension spring thus serves to hold the needle positioning member in a predetermined position relative to the cross guide. Preferably, the counter force provided by the tension spring is strong enough to move the needle cooperating member in the direction opposite to the displacement direction when the tension of the displacement cable is not acting on the needle cooperating member. That is, after a certain number of injections, when the needle cooperating member has been displaced step by step relative to the cross guide to its final position, the tension of the displacement cable can be released, and the reaction force of the tension spring can return the needle cooperating member to its starting position.

[0058] Advantageously, the tension spring is designed as a constant-tension tension spring. In this way, the tension force required to move the needle cooperating member along the cross guide, and therefore the power provided by the associated motor, particularly a piezoelectric motor, is constant regardless of the position of the needle cooperating member relative to the cross guide. For example, the tension spring may consist of a metal band that reels around itself when not tensioned. One end of the metal band is attached to a reel, and the other end is connected to the needle cooperating member. Then, as the needle cooperating member is pulled step by step along the cross guide with the help of the displacement cable, the tension spring generates a constant reaction force. When the tension force of the displacement cable is released, the tension spring automatically rewinds onto the reel, thereby returning the needle cooperating member to its starting position. Preferably, the tension spring provides a tension force between 0.5 N and 2 N, preferably between 0.8 N and 1.2 N, and most preferably about 1 N.

[0059] In a second embodiment, the displacement cable or belt can be arranged to pull the needle cooperating member along the cross guide in opposite first and second displacement directions. In this case, the displacement cable can return the needle cooperating member to its starting position, eliminating the need for a tension spring. In this case, a first wheel and a second wheel can be provided, the first wheel having a first rotation axis and the second wheel having a second rotation axis parallel to and spaced apart from the first rotation axis, and the displacement cable or belt can be wound around the first wheel and the second wheel.

[0060] Preferably, the displacement cable or belt is endless, for example in the form of a loop extending from the first wheel to the second wheel, wrapping around the second wheel 180° or preferably—to prevent slippage of the cable or belt—180° plus a number of additional full revolutions, returning from the second wheel to the first wheel, and wrapping around the first wheel 180° or—again preferably—180° plus a number of additional full revolutions, such that the needle interaction member moves in the first and second displacement directions depending on the direction of rotation of the first and second wheels.

[0061] A tensioning element may be provided to generate tension in the displacement cable or displacement belt transverse to the longitudinal axis of the displacement cable or displacement belt so as to reduce slack in the displacement cable or displacement belt.

[0062] A motor, particularly a piezoelectric motor, can be disposed inside or outside the housing to provide power for rotating the first or second wheel. However, as mentioned above, if the installation space is limited and the housing must be kept small, and therefore a motor cannot be attached to the housing, it is preferable to dispose a drive cable to rotate the first or second wheel, which accordingly extends outside the housing and is connected to a remote motor. In this case, the drive cable can be connected to one of the first and second wheels and wrapped around or around the first or second wheel.

[0063] Alternatively, at least one of the first and second wheels may be mounted on a drive shaft to rotate with rotation of the drive shaft, and a drive cable may be connected to the drive shaft to drive the drive shaft, in which case a third wheel may be mounted on the drive shaft, and the drive cable may be wound around, on, or off the third wheel.

[0064] If the drive cable is arranged to wrap around and off the first or second wheel, or around and off the third wheel, the drive cable may have one end attached to the respective wheel such that when the drive cable is pulled in a first direction, the drive cable unwinds and a portion of the drive cable moves out of the housing, and a tension spring is arranged to pull the drive cable into the housing in an opposite second direction and back onto the respective wheel. If the drive cable is arranged to wrap around the first or second wheel, or around the third wheel, the drive cable may be arranged such that when the drive cable is pulled, a portion of the drive cable moves into the housing and another portion of the drive cable moves out of the housing.

[0065] In all embodiments, the first alignment structure may be arranged on the needle cooperating member and the second alignment structure may be arranged stationary, such that as the needle cooperating member is moved to different positions along the cross guide, the first and second alignment structures engage with each other to define different stationary positions for the needle cooperating member, which supports accurate positioning of the needle cooperating member.

[0066] 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 a plurality of detents or protrusions and the second alignment structure may comprise one or more stationary leaf springs arranged to cooperate with the detents or protrusions. Thus, as the needle cooperating member is moved relative to the cross guide in a displacement direction from one position to the next, the leaf springs are urged rearward to disengage from the detents or protrusions and then snap forward again to re-engage one or more adjacent detents or protrusions.

[0067] Second Aspect - Frame Translation According to a second aspect of the present disclosure, a system includes at least one linear bearing, preferably two parallel linear bearings, and a translation frame arranged to move along the linear bearing or bearings in the advancement and retraction directions of at least one infusion needle, such that the respective movements of the translation frame advance, retract, or both advance and retract the infusion needle or needles. Most preferably, the cross guide, to which the needle cooperating member is coupled, is fixed to the translation frame and moves together with the translation frame in the advancement and retraction directions of the needle. The provision of two parallel linear bearings improves the stability and precision of the system. The two linear bearings preferably take the form of two parallel shafts to which the translation frame is slidably mounted.

[0068] At least one return spring may further be arranged to bias the translation frame to a rest position, for example, the at least one return spring may consist of a coil spring arranged around one linear bearing, or more preferably, two coil springs arranged around each of two parallel linear bearings.

[0069] The drive unit may include an advancement cable arranged to advance or retract at least one infusion needle by pulling the advancement cable. For example, the advancement cable may be arranged to move the translation frame in an advancement and retraction direction along at least one linear bearing, thereby advancing and / or retracting the infusion needle. The advancement cable may be guided through a wall of the housing toward a motor, in particular a piezoelectric motor, located at a location outside the patient, remote from the housing, or more preferably somewhere inside the patient.

[0070] Third variant - Cable in block-and-tackle setup According to a third aspect of the present disclosure, the advancement cable can form part of a block-and-tackle setup, which reduces the amount of power required to advance the needle or acupuncture needle through the penetration area in the housing wall. Therefore, the motor, particularly a piezoelectric motor, for driving the advancement cable can be relatively small.

[0071] When an advancement cable is arranged to move the translation frame along the linear bearing or bearings in forward and reverse directions, a block-and-tackle setup can be comprised of at least one first pulley, preferably two first pulleys, fixed to the translation frame so as to move with the translation frame, and at least one second pulley, preferably two second pulleys, fixed to the housing so as to be stationary. Furthermore, one end of the advancement cable is fixed to the housing or translation frame. Thus, when one end of the advancement cable is fixed to the housing and the advancement cable is pulled to move the translation frame, it winds around the first pulley, which moves with the translation frame, thereby splitting the pulling force required to move the translation frame in half.

[0072] 4th mode: Combined advance and displacement cable According to a fourth aspect of the present disclosure, the drive unit may include a combined advance / retract cable arranged to cause both advancement / retraction of at least one infusion needle and displacement of at least one infusion needle in a displacement direction different from the advance / retraction direction by pulling the advance / retraction cable. For example, a first actuator may be attached to a first end of the advance / retraction cable and a second actuator may be attached to a second end of the advance / retraction cable, the first actuator being arranged to pull and move the advance / retraction cable in a first pulling direction, and the second actuator being arranged to pull and move the advance / retraction cable in a second pulling direction opposite to the first pulling direction.

[0073] This arrangement can be adapted to advance or retract at least one infusion needle by simultaneously actuating the first and second actuators to move the advancement and displacement cables in opposite first and second retraction directions.

[0074] In this case, when the advance / retract cable is arranged to move the translation frame along the linear bearing or bearings in an advance / retract direction, movement of the advance / retract cable in opposite first and second pulling directions can move the translation frame along the linear bearing or bearings. This can be achieved, for example, by at least two first pulleys fixed to the housing so as to be stationary, with the advance / retract cable being guided over one of the two first pulleys fixed to the housing, then guided by the translation frame, and then guided over another of the two first pulleys fixed to the housing. Thus, when the opposite ends of the advance and displacement cables are pulled in opposite first and second pulling directions over the same distance, the translation frame is pulled along the linear bearing or bearings in a direction toward the two first pulleys, such as the advance direction of the infusion needle or needles. The block and tackle setup described above may similarly be provided for the advancement and displacement cables, but in this case this is less critical as twice the power is available as two motors may be used instead of just one, one on each end of the advancement and displacement cables. Again, the return springs described above may be arranged to bias the translating frame towards a rest position so that when the tension on the advancement and displacement cables is reduced, the return springs will automatically return the translating frame to the rest position.

[0075] The arrangement may further comprise actuating either one of the first and second actuators to move the advancement and displacement cables in a first or second retraction direction, while the other of the first and second actuators does not move the advancement and displacement cables to displace the at least one infusion needle in a displacement direction.

[0076] In this case, when the system comprises the needle cooperating element, to which at least one infusion needle is attached, and the cross guide to which the needle cooperating element is coupled, the forward / backward displacement cable can be connected to the needle cooperating element so as to pull and move the needle cooperating element along the cross guide to different positions in the displacement direction. This can be achieved, for example, by at least two second pulleys fixed to the translation frame on opposite sides of the needle cooperating element, with the forward and backward displacement cables being guided over the two second pulleys. Thus, when the forward and displacement cables are pulled in one or the other pulling direction, the needle cooperating element is pulled correspondingly along the cross guide toward each of the two second pulleys, i.e., in the displacement direction of the infusion needle or needles.

[0077] In one embodiment, the advancement and displacement cable may be comprised of two separate cable portions, each connected at one end to the needle cooperating member, however, the advancement and displacement cable may also be a continuous cable with its central portion fixedly connected to the needle cooperating member.

[0078] As is clear from the above, in this fourth aspect, two motors, in particular piezoelectric motors, may be arranged to cooperate to advance or retract at least one infusion needle in an advancing or retracting direction and to individually displace the needle cooperating member in respective opposite displacement directions.

[0079] In particular, in this fourth embodiment, the at least one infusion needle may consist of 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. In this case, the single infusion needle may be welded or potted to the needle cooperating member, or may have a curved portion attached to the needle cooperating member, and the curved portion may be fixedly held in a corresponding curved recess in the needle cooperating member. A needle reinforcement tube may be disposed around the single infusion needle to minimize deflection of the infusion needle when passing through the penetration in the housing wall. A tube for supplying a substance to be injected through the single infusion needle may be connected to the end of the single infusion needle and looped within the housing to have a required range of motion.

[0080] 5th embodiment - infusion needle with lateral supply port According to a fifth aspect of the present disclosure, at least one infusion needle may include a tubular needle body having a distal end, an injection port located at the distal end to allow a substance to be injected through the at least one infusion needle, a supply port located at a position away from the distal end to allow the substance to be received, and a needle lumen inside the tubular needle body connecting the injection port and the supply port, the supply port being a side port located on the side of the tubular needle body. Thus, according to this aspect, the substance to be injected is supplied laterally within the needle body. In this way, the supply lumen does not collide with the rear end of the needle. This rear end is particularly suitable for use in moving the infusion needle in the forward or backward direction. While this aspect is certainly applicable when only a single infusion needle is present, so that only a single supply lumen is required, it may also be advantageously employed in systems including multiple infusion needles. Generally, when multiple needles are provided, the infusion needles may be spaced apart from one another by a distance of between 1 mm and 2 mm, preferably 1.5 mm.

[0081] In either case, the system may include an internal reservoir within the housing that is positioned to hold the substance to be injected. When the infusion needle is in an advanced position that penetrates the penetration area, the supply port is located within the internal reservoir and the injection port is located outside the housing. Thus, in this position, a substance such as an infusion solution can enter the infusion needle through the supply port located on the side of the tubular needle body. When appropriate pressure is applied to the substance in the internal reservoir, the substance flows from the internal reservoir through the supply port, the needle lumen, and the injection port into the patient. In the case of multiple infusion needles, each infusion needle can be positioned to be individually advanced to a position that penetrates the penetration, with each supply port located inside the internal reservoir and each injection port located outside the housing.

[0082] Preferably, the penetration comprises a septum, and the internal reservoir is disposed within the septum such that when the infusion needle is in the retracted position, the supply port is outside the internal reservoir and inside the septum. In this way, when the infusion needle is not in use and not stored, the supply port is hermetically closed by the material of the septum. Alternatively, the internal reservoir within the septum may be dimensioned such that the supply port is located within the internal reservoir when the infusion needle is in the retracted position. This is advantageous so that the needle lumen is filled with substance from the internal reservoir before the infusion needle is moved from the retracted position to the advanced position. Again, in the case of multiple infusion needles, the infusion needles are disposed in this manner, preferably side-by-side.

[0083] More preferably, the injection port on the infusion needle or needle tip can also be located inside the septum when the infusion needle is in the retracted position. In this way, the injection port is safely protected. In this retracted position, the injection port may be located inside the septum but outside the internal reservoir. In this way, the injection port is also hermetically closed by the septum material when the infusion needle is not in use or stored. Furthermore, such an arrangement enhances the stability of the infusion needle and provides some guidance for needle movement. Alternatively, the injection port may be located inside the septum and inside the internal reservoir when the infusion needle is in the retracted position. This is again advantageous for ensuring that the needle lumen is already filled with substance from the internal reservoir before the infusion needle is moved from the retracted position to the advanced position.

[0084] Regarding the supply lumen for supplying the infusion substance to the internal reservoir, if the system comprises one or more linear bearings as described above and a translation frame arranged to move in an advancing or retracting direction along the linear bearings, and each movement of the translation frame advances or retracts the infusion needle, the supply lumen can be arranged to run along the lumen of the linear bearing. In this way, the overall size of the housing can be kept small. The lumen preferably connects directly to the aforementioned internal reservoir.

[0085] Preferably, in this embodiment, as in all other embodiments described so far, the injection port of the infusion needle is designed as a lateral port located at the side of the tubular needle body, as will be explained in more detail below. Thus, the infusion needle is closed at its tip, and the lateral injection port is used for delivering a drug to a specific body site. Therefore, the infusion needle does not cut any material but simply splits upon penetration. Therefore, even if the infusion needle penetrates a substance such as a septum, which may be in the form of fibrosis and / or a self-sealing piercing membrane, the substance will not enter and block the drug delivery passage.

[0086] In all embodiments, the maximum size of the housing is preferably 30mm x 40mm x 6mm.

[0087] Communication mode According to further aspects of the present disclosure, the security of the system against unauthorized third-party intervention can be increased. This is particularly important in the context of wireless communications, which can be easily intercepted and exploited by third parties. Accordingly, the system is preferably configured to do at least one of the following: - wireless communications to and from the controller of the system are encrypted; - Signing data sent by the controller via wireless communication, - Authentication of users of the system involves inputting patient authentication data.

[0088] Preferably, the encrypted wireless communication involves public key encryption and private key decryption, such as the well-known RSA encryption. Other encryption methods may be implemented as well. Preferably, a further level of security is provided in that the private key may be a composite key derived by combining at least a first key and a second key.

[0089] Similarly, with regard to signing of data transmitted wirelessly from a controller, such as from the external or remote controller described above to an internal controller, the signature may involve a private key and subsequent verification of the signed data may involve a corresponding public key.

[0090] Preferably, the data communication includes both encryption and signing. RSA encryption technology allows for both data encryption and digital signing. In the encryption / decryption process, the sender encrypts the data using the receiver's public key, and the receiver subsequently decrypts the data using the receiver's private key. Meanwhile, in the signing / authentication process, the sender signs the (encrypted) data using their private key, and the receiver authenticates the signature using the sender's public key.

[0091] Regarding user authentication involving input of patient authentication data, the system can include a verification unit configured to obtain the patient authentication data. For example, the verification unit can include at least one of a fingerprint reader, a retina scanner, a camera, a graphical user interface for entering a code, and a microphone. Only after positive verification by the verification unit is a specific function of the system enabled. For example, positive verification can enable a controller to process specific data or open a communication channel between two controllers of the system, such as a wireless communication channel.

[0092] Alternatively or additionally, the system may include a sensory generator for generating sensations detectable by the patient's senses. In this case, the patient can input authentication data related to what the patient senses into the system. Authenticating the user then involves verifying, by a verification unit, that the authentication data entered by the user matches data from the sensory generator related to the sensation generated by the sensory generator. Again, certain system functions are enabled only after positive verification by the verification unit. For example, positive verification may enable a controller to process certain data or open a communication channel between two controllers of the system, such as a wireless communication channel.

[0093] In this context, the sensation generator is configured to generate at least one of the following sensations detectable by the patient's senses: - the vibration may include, for example, a mechanical vibration of a fixed frequency; This sound may involve the superposition of mechanical vibrations of fixed frequencies, for example The optical signal may comprise a non-visible light pulse, such as an infrared pulse, The optical signal comprises, for example, a visual light pulse; - an electrical signal, such as a current pulse; The thermal signal may for example comprise a heat pulse.

[0094] Communication and Housing Further provided is an external device configured to communicate with an implantable medical device when implanted in a patient, the external device comprising a display device and a housing unit configured to mechanically and detachably connect to the display device, the housing comprising a first communication unit for receiving communications from the display device and a second communication unit for wirelessly transmitting communications to the implantable medical device.

[0095] According to one embodiment, the external device comprises a portable electronic device.

[0096] According to one embodiment, the external device is configured to communicate with the implantable medical device to change the operational state of the implantable medical device. An advantage of this embodiment is that the operational state of the implantable medical device can be changed remotely.

[0097] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device, an advantage of this embodiment is that communication with the display device can be achieved without the need for wires.

[0098] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using a first communication frequency, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication frequency, wherein the first and second communication frequencies are different. An advantage of this embodiment is that the possibility of interference is reduced.

[0099] According to one embodiment, the second communication unit is configured to wirelessly communicate with the implantable medical device using electromagnetic waves at a frequency of 100 kHz or less.

[0100] According to one embodiment, the second communication unit is configured to wirelessly communicate with the implantable medical device using electromagnetic waves with a frequency of 40 kHz or less. An advantage of this embodiment is that titanium, which is commonly used in medical devices, is transparent to electromagnetic waves with a frequency of 40 kHz or less.

[0101] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using electromagnetic waves with a frequency above 100 kHz, an advantage of this embodiment is that the frequency spectrum below 100 kHz remains noise-free for communication with the medical implantable device.

[0102] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using a first communication protocol, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication protocol, the first and second communication protocols being different. An advantage of this embodiment is that the protocols for communication of the first and second communication units can be independently selected depending on which protocol is more suited to the needs of the communication units.

[0103] 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, an advantage of this embodiment being that the antennas for communication of the first and second communication units can be independently selected depending on which antenna better suits the needs of the communication units.

[0104] According to one embodiment, the first communication unit is a wired communication unit for wired communication with the display device. An advantage of this embodiment is that the communication of the first communication unit is reliable and secure.

[0105] According to one embodiment, the display device comprises a first communication unit for communicating with the housing unit and a second communication unit for wirelessly communicating with a second external device, an advantage of this embodiment being that it allows communication with additional external devices, thereby providing redundancy and reliability.

[0106] According to one embodiment, the second communication unit of the display device is configured to communicate with a second external device via the Internet. An advantage of this embodiment is that the display device can communicate with devices at a distance.

[0107] According to one embodiment, the first communication unit of the display device is a wireless communication unit for wireless communication with the housing unit, an advantage of this embodiment being that the communication unit can be connected to the housing unit without wires.

[0108] According to one embodiment, the first communication unit of the display device is configured to wirelessly communicate with the housing unit using a first communication frequency, and the second communication unit of the display device is configured to wirelessly communicate with a second external device using a second communication frequency, the first and second communication frequencies being different. An advantage of this embodiment is that the possibility of interference is reduced and the signal-to-interference and noise ratio is improved.

[0109] According to one embodiment, a first communication unit of the display device is configured to wirelessly communicate with the housing unit using a first communication protocol, and a second communication unit of the display device is configured to wirelessly communicate with a second external device using a second communication protocol, the first and second communication protocols being different. An advantage of this embodiment is that the first and second communication units can independently select a protocol for communication depending on which protocol is more suitable for the needs of the communication units.

[0110] 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 a second external device, an advantage of this embodiment being that the antennas for communication of the first and second communication units can be independently selected depending on which antenna better suits the needs of the communication units.

[0111] According to one embodiment, the first communication unit is a wired communication unit for wired communication with the housing unit, an advantage of this embodiment being that the communication of the first communication unit is reliable and secure.

[0112] According to one embodiment, the display device is configured to display a user interface to the patient. An advantage of this embodiment is that the patient can communicate with the housing unit using a display device that is familiar to them.

[0113] According to one embodiment, the housing unit is configured to transmit information regarding the display of the user interface to the display device, an advantage of this embodiment being that the patient can receive the information using a display device that is familiar to them.

[0114] According to one embodiment, the display device is configured to receive input from the patient regarding communication between the implantable medical device and the display device and to transmit a signal to the housing unit based on the received input. An advantage of this embodiment is that the patient can communicate with the housing unit using a familiar display device.

[0115] According to one embodiment, the display device comprises a tooth cleaner configured to display a user interface and receive input from the patient. An advantage of this embodiment is that the patient can interact with the information in a familiar manner.

[0116] According to one embodiment, the housing unit is configured to display a user interface to the patient. An advantage of this embodiment is that the housing unit can receive user input.

[0117] According to one embodiment, the first communication unit of the housing unit is configured to receive, using the second communication unit, a communication from the implantable medical device relating to an input from the patient and to wirelessly transmit a signal to the implantable medical device based on the received input. An advantage of this embodiment is that the housing unit acts as an extra node in the communication between the display device and the implantable medical device, thereby allowing for communication monitoring.

[0118] According to one embodiment, the second communication unit of the housing unit is configured to communicate wirelessly with the implantable medical device using a standard network protocol, with the advantage of this embodiment being that the communication unit is inexpensive to implement and the protocol is reliable.

[0119] According to one embodiment, the standard network protocol is one of the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, a GSM type protocol.

[0120] According to one embodiment, the second communication unit of the housing unit comprises a Bluetooth transceiver.

[0121] According to one embodiment, the second communication unit of the housing unit is configured to wirelessly communicate with the implantable medical device using a proprietary network protocol. An advantage of this embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.

[0122] According to one embodiment, the second communication unit of the housing unit comprises an UWB transceiver, which has the advantage that high data rates can be communicated via the second communication unit.

[0123] According to one embodiment, the first communication unit of the housing unit is configured to communicate wirelessly with the display device using a standard network protocol, the advantages of this embodiment being that the communication unit is inexpensive to implement and the protocol is reliable.

[0124] According to one embodiment, the standard network protocol is an NFC-type protocol. The advantage of this embodiment is that it limits the distance between communicating devices and therefore provides protection against eavesdropping attacks.

[0125] According to one embodiment, the first communication unit of the housing unit is configured to wirelessly communicate with the display device using a proprietary network protocol. An advantage of this embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.

[0126] According to one embodiment, the communication range of the first communication unit of the housing unit is smaller than the communication range of the second communication unit of the housing unit, an advantage of this embodiment being that energy is saved by selecting the first communication unit when its communication range is sufficient.

[0127] According to one embodiment, the communication range of the first communication unit of the display device is smaller than the communication range of the second communication unit of the display device, an advantage of this embodiment is that energy is saved by selecting the first communication unit when its communication range is sufficient.

[0128] 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 based on the distance between the housing unit and the display device. An advantage of this embodiment is that distance is used as a security and authorization factor.

[0129] According to one embodiment, at least one of the housing unit and the display device is configured to enable communication between the housing unit and the display device based on the housing unit being mechanically connected to the display device, an advantage of this embodiment being improved security against man-in-the-middle attacks.

[0130] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the implantable medical device based on the distance between the housing unit and the implantable medical device. An advantage of this embodiment is that distance is used as a security and authorization factor.

[0131] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communications received from the display device, an advantage of this embodiment being that the encrypted communications are protected from access by unwanted third parties.

[0132] According to one embodiment, the housing unit is further adapted to transmit encrypted communications to the implantable medical device using the second communication unit. An advantage of this embodiment is that the encrypted communications are protected from unwanted third-party access.

[0133] According to one embodiment, the second communication unit of the display device is configured to be disabled to allow at least one of communication between the display device and the housing unit and communication between the housing unit and the implantable medical device.

[0134] The display device in any of the embodiments described herein may be a wearable device or a handset, the advantage of this embodiment being that the device is mobile and can be used wherever needed.

[0135] According to one embodiment, the housing unit constitutes a case for the wearable device or handset, the advantage of which is that it can protect the wearable device or handset from mechanical damage.

[0136] Further provided is a housing unit configured to communicate with an implantable medical device when implanted in a patient, the housing unit being configured to mechanically connect to a display device and comprising a first communication unit for communicating with the display device and a second communication unit for wirelessly communicating with the implantable medical device.

[0137] According to one embodiment, the display device is a wearable device or a mobile phone and the housing unit constitutes a case for the wearable device or the mobile phone.

[0138] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device.

[0139] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using a first communication frequency, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication frequency, wherein the first and second communication frequencies are different.

[0140] According to one embodiment, the housing unit is configured to transmit information regarding the display of the user interface to the display device.

[0141] According to one embodiment, the housing unit is configured to receive patient input from a display device.

[0142] According to one embodiment, the housing unit is configured to display a user interface to the patient.

[0143] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the display device based on a distance between the housing unit and the display device.

[0144] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the display device based on the housing unit being mechanically connected to the display device.

[0145] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the implantable medical device based on a distance between the housing unit and the implantable medical device.

[0146] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communications received from the display device.

[0147] According to one embodiment, the housing unit is further adapted to transmit encrypted communications to the implantable medical device using the second communications unit.

[0148] According to one embodiment, when the housing is mechanically connected to the display device, the minimum bounding box of the housing unit and the display device is not more than 10% wider, not more than 10% longer, and not more than 100% taller than the minimum bounding box of the display device.

[0149] According to one embodiment, the housing unit includes one or more switches configured for use by the patient when the housing is not mechanically connected to the display device.

[0150] According to one embodiment, the switch is at least partially covered by the display device when the display device is mechanically connected to the housing unit.

[0151] According to one embodiment, at least a portion of the housing flexes to mechanically connect to the display device.

[0152] According to one embodiment, at least a portion of the housing is configured to sandwich a display device.

[0153] According to one embodiment, the housing is configured to cover at least one side of the display device when mechanically connected to the display device.

[0154] According to one embodiment, the housing is configured to be mechanically connected to a display device by means of a device that is mechanically connected to the housing and the display device.

[0155] General Security Module Also provided is an implantable controller for an implantable medical device. The implantable controller includes a wireless transceiver for wireless communication with an external device, a security module, and a central unit configured to communicate with the wireless transceiver, the security module, and the implantable medical device. The wireless transceiver is configured to receive a communication from the external device including at least one instruction for the implantable medical device and to transmit the received communication to the central unit. The central unit is configured to transmit a secure communication derived from the communication received from the external device to the security module, the security module being 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, the central unit being configured to communicate at least one instruction to the implantable medical device, the at least one instruction being based on the response communication or a combination of the response communication and the communication received from the external device.

[0156] According to one embodiment, the security module comprises a set of rules for accepting communications from a central device.

[0157] According to one embodiment, the wireless transceiver is configured to be placed in an off mode in which wireless communications cannot be sent or received by the wireless transceiver, and the set of rules includes a rule that provides that communications from the central unit are accepted only when the wireless transceiver is placed in the off mode.

[0158] According to one embodiment, the set of rules includes a rule that provides that the radio transceiver will only accept communications from the central unit if it has been in off mode for a specified period of time.

[0159] According to one embodiment, the central device is configured to verify the digital signature of the communication received from the external device.

[0160] According to one embodiment, the set of rules includes a rule that provides that a communication from the central unit is accepted only if the digital signature of the received communication is verified by the central unit.

[0161] According to one embodiment, the central device is configured to check the size of the communication received from the external device.

[0162] According to one embodiment, the set of rules includes a rule that provides that a communication from the central unit is accepted only if the size of the received communication is verified by the central unit.

[0163] The wireless transceiver of any of the preceding embodiments may be configured to receive a message from an external device that is encrypted with at least a first and a second layer of encryption, and the central unit may be configured to decrypt the first layer of encryption and transmit at least a portion of the message that constitutes the second layer of encryption to the security module. 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.

[0164] According to one embodiment, the central device may be configured to decrypt the portion of the message that includes the digital signature so that the digital signature can be verified by the central device.

[0165] According to one embodiment, the central device is configured to decrypt the portion of the message that includes the message size information so that the message size can be verified by the central device.

[0166] According to one embodiment, the central device is configured to decrypt the first and second parts of the message, the first part including a checksum for verifying the authenticity of the second part.

[0167] According to one embodiment, the response communication sent from the security module includes a checksum, and the central device may be configured to use the received checksum to verify the authenticity of at least a portion of the message decrypted by the central device.

[0168] According to one embodiment, the set of rules includes rules relating to data transfer rates between the central unit and the security modules.

[0169] The security module in any embodiment herein may be configured to decrypt the portion of the message containing the digital signature that was encrypted with a second encryption layer so that the digital signature can be verified by the security module.

[0170] The central unit may be configured to be able to decode some of the communications received from the external unit only when the wireless transceiver is placed in the off mode.

[0171] According to one embodiment, the central unit is capable of communicating at least one command to the implantable medical device only when the wireless transceiver is placed in the off mode.

[0172] According to one embodiment, the implantable controller is configured to receive, using a wireless transceiver, a message from an external device including a first unencrypted portion and a second encrypted portion, decrypt the encrypted portion, and use the decrypted portion to verify the authenticity of the unencrypted portion.

[0173] According to one embodiment, the central device is configured to transmit the encrypted portion to the security module, receive a response communication from the security module based on the information contained in the encrypted portion being decrypted by the security module, and verify the authenticity of the unencrypted portion using the response communication.

[0174] According to one embodiment, the unencrypted portion comprises at least a portion of at least one instruction to an implantable medical device.

[0175] The implantable controller may be configured to use the wireless transceiver to receive a message from an external device containing information related to at least one of a physiological parameter of the patient and a physical parameter of the implantable medical device, and to verify the authenticity of the message using the received information.

[0176] The patient's physiological parameters may include at least one of body temperature, heart rate, and saturation value.

[0177] The physical or functional parameters of the implanted medical device may include at least one of the current settings or values ​​of the implanted medical device, advance instructions sent to the implanted medical device, and an ID of the implanted medical device.

[0178] According to one embodiment, the portions of the message that make up the information are encrypted, and the central device is configured to transmit the encrypted portions to the security module and to receive a response communication from the security module based on the information decrypted by the security module.

[0179] According to one embodiment, the security module comprises a hardware security module including at least one hardware-based key, which may correspond to a hardware-based key in an external device or may be a hardware-based key on a key card connectable to the external device.

[0180] According to one embodiment, the security module comprises a software security module including at least one software-based key. The software-based key may correspond to a software-based key in an external device. The software-based key may correspond to a software-based key on a key card connectable to the external device. In either embodiment, the security module may comprise a combination of software-based keys and hardware-based keys.

[0181] In any of the foregoing embodiments, the implantable controller may include at least one cryptographic processor.

[0182] The wireless transceiver, in either embodiment, may be configured to receive communications from a portable external device.

[0183] According to one embodiment, the at least one instruction to the implantable medical device may include an instruction to change an operating state of the implantable medical device.

[0184] The wireless transceiver may be configured to wirelessly communicate with an external device using electromagnetic waves at frequencies below 100 kHz or frequencies below 40 kHz.

[0185] According to one embodiment, the wireless transceiver is configured to communicate wirelessly with the external device using a first communication protocol, and the central device is configured to communicate with the security module using a second, different communication protocol.

[0186] In any of the embodiments, the wireless transceiver may be configured to wirelessly communicate with the external device using a standard network protocol, which may be selected from a list comprising an RFID-type protocol, a WLAN-type protocol, a Bluetooth-type protocol, a BLE-type protocol, an NFC-type protocol, a 3G / 4G / 5G-type protocol, and a GSM-type protocol.

[0187] The wireless transceiver, in some embodiments, is configured to wirelessly communicate with external devices using a proprietary network protocol.

[0188] According to one embodiment, the wireless transceiver comprises a UWB transceiver.

[0189] According to one embodiment, the security module and / or the central unit and / or the radio transceiver are configured within the controller.

[0190] The external unit in any of the embodiments herein may be a wearable device or a handset. An advantage of this embodiment is that the device is mobile and can be used wherever needed.

[0191] The implantable medical device may further include a receiving unit comprising: at least one coil configured to receive transcutaneously transmitted 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; and a switch disposed between the variable impedance and the coil to turn 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 to vary the impedance and thereby adjust the coil based on the measured parameter and the switch to turn off the electrical connection between the variable impedance and the coil in response to the measured parameter exceeding a threshold.

[0192] According to one embodiment, the controller is configured to vary the variable impedance in response when the measured parameter exceeds a threshold value.

[0193] According to one embodiment, the measurement unit is configured to measure a parameter related to the energy received by the coil over a period of time.

[0194] According to one embodiment, the measurement unit is configured to measure a parameter related to the change in energy received by the coil.

[0195] According to one embodiment, a first switch is located at a first end of the coil, and the implantable medical device further includes a second switch located at a second end of the coil so that the coil can be completely disconnected from the rest of the implantable medical device.

[0196] According to one embodiment, the receiving unit is configured to receive the transcutaneously delivered energy in pulses according to a pulse pattern, and the measuring unit is configured to measure a parameter related to the pulse pattern.

[0197] According to one embodiment, the controller is configured to control the variable impedance in response to deviations of the pulse pattern from a predefined pulse pattern.

[0198] According to one embodiment, the controller is configured to control a switch to turn off an electrical connection between the variable impedance and the coil in response to the pulse pattern deviating from a predefined pulse pattern.

[0199] According to one embodiment, the measurement unit is configured to measure a temperature within the implantable medical device or within the patient's body, and the controller is configured to control the first and second switches in response to the measured temperature.

[0200] According to one embodiment, the variable impedance is comprised of a resistor and a capacitor, a resistor and an inductor, and / or an inductor and a capacitor.

[0201] The variable impedance may be comprised of a digitally tuned capacitor. The variable impedance may be comprised of a digital potentiometer. The variable impedance may be comprised of a variable inductor.

[0202] According to one embodiment, the variation in impedance is configured to reduce the effective power received by the receiving unit.

[0203] According to one embodiment, a variable impedance is placed in series with the coil.

[0204] According to one embodiment, the variable impedance is placed in parallel with the coil.

[0205] According to one embodiment, the implantable medical device further comprises an energy storage unit connected to the receiving unit, the energy storage unit configured to store the energy received by the receiving unit.

[0206] Alternative: Surface Coating Another aspect of the present disclosure relates to mitigating fibrin formation caused by contact between a medical implant, such as the implantable system described above, and a patient's tissue or bloodstream. As is well known, the body tends to react to medical implants, in part because the implant is a foreign body, in part because the implant mechanically interacts with the body's tissues and / or the bloodstream. The implantation of a medical device and / or biomaterial into a patient's tissue can trigger a foreign body response, leading to the formation of foreign body giant cells and the development of a fibrous capsule surrounding the implant. The formation of a dense fibrous capsule that isolates the implant from the host is a common underlying cause of implant failure. The implantation of a medical device and / or biomaterial in the bloodstream can also cause the formation of a fibrous capsule due to the attraction of certain cells in the bloodstream. Implants can cause blood clots due to fibrin formation, potentially leading to patient complications. Implants that come into contact with blood or remain in the body can also cause bacterial infections. One common method of combating blood clot formation is the use of various types of blood thinners. One commonly used blood thinner is heparin, but heparin has undesirable side effects.

[0207] Generally, fibrin is an insoluble protein produced in part in response to bleeding and is the main component of blood clots. Fibrin is formed from fibrinogen, a soluble protein produced in the liver and present in plasma. When bleeding occurs due to tissue injury, fibrinogen is converted to fibrin at the wound site by the action of the clotting enzyme thrombin. Fibrin, together with platelets, forms a hemostatic plug or clot at the wound site. The process of fibrinogenesis from fibrinogen first attracts platelets. Platelets have thrombin receptors on their surface that bind to serum thrombin molecules. These molecules convert soluble fibrinogen to fibrin. Fibrin then forms long chains of tough, insoluble protein bound to platelets. Fibrin then crosslinks, hardens, and contracts. This is made possible by factor XIII, an enzyme present in human blood. Fibrin is also produced in the foreign body response. When a foreign substance is detected in the body, the immune system is attracted to it and attempts to break it down. If this degradation is not successful, fibroblasts produce an envelope, which forms a physical barrier to isolate the body from the foreign body. This can further develop into a fibrin sheath. If the foreign body is an implant, this can interfere with the function of the implant.

[0208] Thus, when implants are implanted in the body, they may come into contact with flowing blood. This can lead to platelets adhering to the implant's surface. Platelets can then convert fibrinogen in the blood into fibrin, forming a sheath on and / or around the implant. This can cause the implant to malfunction and potentially lead to blood clots that are dangerous to the patient. However, even implants that do not come into contact with blood can malfunction due to fibrin formation. In this case, a foreign body reaction may be the underlying cause of the malfunction. Furthermore, the implantation of a foreign body into the human body can trigger an inflammatory response. This response generally persists until the foreign body is encapsulated in a relatively dense layer of fibrous connective tissue that protects the body from foreign bodies. This process may begin with the implant spontaneously acquiring a layer of host proteins. A surface modified with blood proteins allows cells to adhere to the surface and allows monocytes and macrophages to interact with the implant surface. Macrophages secrete proteins that regulate fibrosis and form a fibrotic capsule around the foreign body, i.e., the implant. In reality, the fibrous capsule can form a dense layer of excess fibrous connective tissue, whose inelastic properties can lead to hardening, tightening, deformation, and distortion of the implant, potentially leading to reoperation.

[0209] Implants can also cause various types of infections. Bacterial colonization leading to implant-related infections is a known problem with many types of implants. For example, Staphylococcus aureus and Staphylococcus aureus, which are normal skin bacteria, tend to colonize foreign bodies like implants and can cause infections. The problem with Staphylococcus aureus is that it forms a biofilm around the implant, sealing off the bacterial niche from the external environment. This makes it difficult for the host's defense system to deal with the bacteria. There are other examples of bacteria and processes that cause implant-related infections.

[0210] Thus, according to this further aspect of the present disclosure, to mitigate fibrin formation caused by contact between the components of the implantable system and the patient's tissue or flowing blood, the implantable components of the system may include a specific coating disposed on the exterior surface of each of the components. The coating may be composed of at least one layer of a biomaterial, preferably a fibrin-based material. The coating may include at least one drug or substance with antithrombotic, antibacterial, and / or antiplatelet properties. The drug or substance may be encapsulated in a porous material.

[0211] A second coating may be provided over the first coating. The second coating may be a different biological material from the first coating. In particular, the first coating may comprise a perfluorocarbon layer chemically attached to the surface, and the second coating may comprise a liquid perfluorocarbon layer.

[0212] More preferably, the surface may be comprised of a metal such as at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.

[0213] Finally, the surface may include a micropattern, which may be etched into the surface prior to insertion into the body. A layer of biomaterial may be coated onto the micropattern.

[0214] Further aspects - safe drug injection A further aspect of the present disclosure relates to a method for reliably injecting a drug into a patient's blood vessel, in particular a blood vessel, such as an artery or vein, using a system according to any one of the embodiments disclosed herein, i.e., a system with an injection needle that is advanced into and retracted from the blood vessel.

[0215] First aspect - short needle port distance. According to a first sub-aspect of this further aspect, as already mentioned above, the infusion needle can have an injection port on its side. Preferably, the injection port is spaced less than 2 mm, more preferably less than 1 mm, and even more preferably 0.5 to 1 mm, from the distal end of the at least one infusion needle. This is particularly useful when the diameter of the blood vessel to be punctured is small. That is, because the injection port is a side port and is located very close to the distal end of the infusion needle, the infusion needle needs to be advanced into the blood vessel only a very short distance to position the injection port within the blood vessel, thereby preventing the distal end of the infusion needle from extending out of the blood vessel through the opposite blood vessel wall. The above-mentioned spacing relates to the distance between the tip of the infusion needle and the end of the injection port closest to the tip. In this context, the injection port preferably extends in the longitudinal direction of the infusion needle by 0.5 mm or less, more preferably 0.3 mm or less, and even more preferably 0.2 mm or less.

[0216] More preferably, the injection port may have a larger extension in a direction perpendicular to the longitudinal direction of the infusion needle than the extension of the injection port in the longitudinal direction of the infusion needle, thereby reducing the longitudinal extension of the injection port while maintaining a large cross-sectional area of ​​the injection port, so that when the infusion needle advances into the blood vessel, the injection port is completely accommodated in the lumen of the blood vessel due to its short longitudinal extension.

[0217] Thus, an at least partially implantable system for injecting a substance into a patient's body may be configured as follows: a housing for implantation within a patient's body, the housing having an outer wall with a penetration; at least one infusion needle disposed within the housing; a drive unit arranged to advance and retract the at least one infusion needle in opposite directions so that, upon advancement of the at least one infusion needle, the tip of the at least one infusion needle penetrates said penetration portion and a substance can be injected through said penetration portion via the at least one infusion needle; -wherein the infusion needle is designed as described above, i.e., at least one infusion needle has an injection port on its side, said injection port being spaced from the tip end of the at least one infusion needle by less than 2 mm, preferably less than 1 mm, more preferably 0.5 to 1 mm, preferably 0.5 mm or less, more preferably 0.3 mm or less, even more preferably 0.2 mm or less, and even more preferably having an extension perpendicular to the longitudinal direction of the infusion needle greater than the extension of the injection port in the longitudinal direction of the infusion needle.

[0218] Second sub-aspect - Inclined needle According to a second sub-aspect of this further aspect, the infusion needle can be positioned so that, upon advancement, it enters the container in an oblique manner, i.e., non-perpendicularly. This can be achieved by positioning the infusion needle so that, upon advancement, it does not extend perpendicularly from the housing but rather at an oblique angle relative to the outer surface of the housing. To this end, the outer wall of the housing of the implantable system can have an outer surface extending in a first direction, configured so that a longitudinal blood vessel, such as a vein or artery, can be positioned adjacent to said outer surface with the central axis of the longitudinal blood vessel extending parallel to said first direction. If the direction of advancement / retraction of at least one infusion needle is in a plane defined by the first direction of the outer wall surface of the housing and the central axis of the longitudinal blood vessel, and is positioned at an oblique angle relative to said first direction, the infusion needle enters the blood vessel at such an oblique angle upon advancement / retraction. In other words, the infusion needle is positioned inside the housing at an angle relative to the outer wall of the housing, more specifically, relative to the outer surface of the outer wall of the housing. In any event, the infusion needle is inclined relative to the outer wall of the housing by an angle of preferably less than 90°, preferably within the range of 10° to 80°, more preferably within the range of 20° to 40°.

[0219] Thus, the infusion needle may be configured to inject into a blood vessel within a patient's body, with at least one side of the infusion needle closest to the blood vessel being configured to inject at an angle α of less than 45° toward the longitudinal axis of the blood vessel. More specifically, the infusion needle preferably has a chamfer toward the tip, the chamfer being oriented toward the blood vessel, and the angle β between the blood vessel and the chamfer being at least 15°.

[0220] In particular, when the penetration has at least one tubular opening for an infusion needle and the infusion needle 11 is sealed fluid-tight against the at least one tubular opening, as will be explained in more detail below, the infusion needle is preferably positioned to inject into a blood vessel in the patient's body with the side of the needle closest to the blood vessel configured to inject at an angle of less than 45° to the long axis of the blood vessel; and / or The infusion needle has a chamfer toward the tip, and is configured to inject into a blood vessel in a patient's body, with the side of the infusion needle closest to the blood vessel angled less than 45° toward the long axis of the blood vessel, and the bevel is oriented toward the blood vessel, with an angle of at least 15° between the blood vessel and the bevel.

[0221] When at least two injection needles with at least one tubular opening and two penetrations, one for each of the at least two injection needles, are provided, each of the at least two injection needles is preferably sealed fluid-tight with respect to the at least one tubular opening, and the at least two injection needles may be configured to inject into a blood vessel in a patient's body, with the sides of the at least two injection needles closest to the blood vessel being angled at less than 45° towards the long axis of the blood vessel.

[0222] The at least one injection needle may further be configured to inject any of the following: a blood vessel in a patient's body, wherein the side of at least one injection needle closest to the blood vessel is configured to inject at an angle of less than 45° toward the longitudinal axis of the blood vessel; - adipose tissue by penetrating the fibrous tissue accumulated around at least one injection needle, - muscle tissue by penetrating the fibrous tissue formed around at least one injection needle.

[0223] It is further preferred to provide a holder configured to hold the longitudinal blood vessel positioned relative to the housing when the at least one infusion needle is advanced such that the central axis of the blood vessel extends parallel to said first direction on the outer surface of the outer wall of the housing, the holder ensuring on the one hand that the blood vessel is correctly positioned and on the other hand that the blood vessel does not move when it is pierced by the infusion needle.

[0224] Preferably, the holder is configured to surround part or preferably the entire circumference of the longitudinal container, i.e., to prevent the container from slipping out of the holder. In this regard, the holder may include a movable lid configured to open and close the holder to position and retain said part of the longitudinal container within the holder.

[0225] More preferably, the first direction may change in a curved manner. That is, as described above, the outer surface of the housing may extend in the first direction and may be configured so that a longitudinal container can be placed adjacent to said outer surface. When the first direction changes in a curved manner, i.e., when the surface on which the blood vessel is placed is curved in an appropriate direction, the distal end of the infusion needle being advanced into the blood vessel through the blood vessel wall is less likely to penetrate the opposing blood vessel wall upon further advancement.

[0226] Thus, an at least partially implantable system for injecting a substance into a patient's body may be configured as follows: a housing (or casing) for implantation in a patient's body, the housing having an outer wall with a penetration; at least one infusion needle arranged in the housing to penetrate the penetration region and configured to be advanced and retracted in opposite forward and retracted directions between an advanced position and a retracted position, the at least one infusion needle being adapted to inject a substance into the body of a patient through the at least one infusion needle when the infusion needle is in the advanced position and being unable to inject a substance into the body of a patient through the at least one infusion needle 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 opposite directions such that, upon advancement of the at least one infusion needle, a tip of the at least one infusion needle penetrates said penetration portion and a substance can be injected from said penetration portion via the at least one infusion needle; - the outer wall of the housing has an outer surface extending in a first direction, a longitudinal container can be placed adjacent to the outer surface, the central axis of the container is configured to extend parallel to the first direction, and the forward and backward directions of at least one infusion needle are arranged in a plane defined by the first direction and the longitudinal axis of the container at an oblique angle to the first direction, the oblique angle being preferably in the range of 10° to 80°, more preferably in the range of 20° to 40°, and the system may further include the holder.

[0227] Bent needle According to a further preferred embodiment, the beveled needle is a curved needle. More specifically, at least the distal end portion of the infusion needle (the portion including the distal end of the infusion needle) is curved within a curvature plane. This provides certain advantages. First, as described above, the effect of a curved needle is similar to the effect of a curved surface on which a blood vessel is placed. That is, when a curved needle is advanced into a blood vessel by rotating the infusion needle about an axis that substantially corresponds to the axis along which the distal end portion of the infusion needle is curved, the distal end portion of the infusion needle, which has been advanced into the blood vessel through the blood vessel wall, is less likely to penetrate the opposing blood vessel wall during further advancement. Therefore, the advancement and retraction of the infusion needle in the forward and retraction directions preferably involves rotation of the distal end portion of the infusion needle about a rotation axis that is perpendicular to the curved surface. It is further preferred to combine a curved needle with a curved surface on which a blood vessel is placed.

[0228] The second advantage is that the housing that houses the rotatable curved needle can be designed to be smaller than the housing that houses one or more straight infusion needles that can be displaced longitudinally in the direction of the infusion needle's advancement and retreat.

[0229] Thus, an at least partially implantable system for injecting a substance into a patient's body may be an at least partially implantable system for injecting a substance into a patient's body, comprising: a housing or casing adapted for implantation within a patient's body, the housing or casing having an outer wall with a penetration; at least one infusion needle arranged in the housing or casing to penetrate the penetration region and configured to advance and retract in opposite directions between an advanced position and a retracted position, wherein when the infusion needle is in the advanced position, the system is adapted to inject a substance into the patient's body through the at least one infusion needle, and when the infusion needle is in the retracted position, it is not possible to inject a substance into the patient's body through the at least one infusion needle; the infusion needle is inclined at an angle of inclination ranging from 10° to 80° relative to the outer wall, and the tip portion of at least one infusion needle, which includes the tip portion of the at least one infusion needle, is curved in a plane of curvature; Preferably, the advancement and retraction of the at least one infusion needle in the advancement and retraction directions comprises a rotation of a tip portion of the at least one infusion needle about an axis of rotation that is perpendicular to the plane of curvature.

[0230] Further aspects - needle through the diaphragm A further aspect of the present disclosure relates to a problem that can arise when an infusion needle has an injection port on its side. In this case, as the infusion needle passes through a diaphragm separating the interior and exterior of the housing, the needle punctures the diaphragm, causing the injection port on the side of the needle to move along the material of the diaphragm, such as a silicone material or other polymeric material. This can scratch the diaphragm, resulting in wear of the diaphragm material that can be carried into the patient's body.

[0231] First Sub-Aspect—Needle in Tube According to a first sub-aspect of this further aspect, the system may be configured such that, when the at least one infusion needle is in the retracted position, the distal end of the infusion needle is disposed within the tube, and the inner surface of the tube and the outer surface of the infusion needle are fluid-tightly sealed to each other. This results in a sealed injection port, i.e., reliably preventing fluids, such as blood, from entering the injection port through the tube. Preferably, the inner diameter of the inner surface of the tube and the outer diameter of the outer surface of the at least one infusion needle match each other to form a fluid-tight seal to prevent fluids from entering the injection port through the tube. That is, these two surfaces form a sealing surface. Preferably, the injection port is located at this sealing portion 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 constituting the portion where the injection port is located—are made of a ceramic material. Ceramics can be manufactured with high precision to provide opposing sliding surfaces with close tolerances, thereby creating a fluid-tight fit between the inner and outer surfaces. Thus, when the infusion needle and its injection port are advanced to extend from the tubing into the housing, the needle does not need to punch a hole to penetrate the wall of the housing. Rather, a hole is already provided in the wall by the tubing where the tip of the infusion needle resides. This reduces the risk of material being scraped off the wall by the edge of the injection port opening as the infusion needle advances. When the infusion needle is in the retracted position, one end of the tubing opens to the outside of the housing, but because the inner surface of the tubing and the outer surface of the infusion needle are or are fluid-tight sealed to each other, there is no risk of any bodily fluids or fibrosis entering or blocking the needle. Rather, as the needle is advanced to extend from the tubing, fibrosis within the tubing is pushed out, and fibrosis before the tubing is penetrated by the infusion needle.

[0232] Thus, an at least partially implantable system for injecting a substance into a patient's body may be configured as follows: a housing for implantation within a patient's body, the housing having an outer wall with a penetration; at least one infusion needle disposed within the housing; a drive unit arranged to advance and retract the at least one infusion needle in opposite directions so that, upon advancement of the at least one infusion needle, a tip of the at least one infusion needle penetrates said penetration portion and a substance can be injected through said penetration portion via the at least one infusion needle; an injection port is provided on a side of the at least one infusion needle, and when the at least one infusion needle is in the retracted position, the distal end of the infusion needle is disposed within the tube, and the inner surface of the tube and the outer surface of the at least one infusion needle are fluid-tight sealed against each other to prevent the infiltration of fluids, e.g., blood, preferably the inner diameter of the inner surface of the tube and the outer diameter of the outer surface of the at least one infusion needle match each other to provide a fluid-tight seal; preferably the inner diameter of the inner surface of the tube and the outer diameter of the outer surface of the at least one infusion needle match each other to provide a fluid-tight seal against each other to prevent the infiltration of fluids through the tube and further into the injection port, 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 the part of the infusion needle that constitutes the injection port, are made of a ceramic material;

[0233] Second aspect - Pre-set stretch opening According to a second sub-aspect of this further aspect, the penetration area of ​​the housing's outer wall, which is penetrated by the infusion needle, may be at least partially made of an elastic material having a pre-configured passage for at least one infusion needle to pass through. The passage is typically closed by an elastic force generated by the elasticity of the elastic material, such as silicone or any other elastic polymeric material. Therefore, no external force is required to keep the passage closed against the infiltration of bodily fluids or the development of fibrosis. Then, when the infusion needle and its injection port are advanced through the pre-configured passage, the needle does not need to puncture the housing wall to penetrate it. Rather, the passage is already provided in the wall and only needs to be opened. For example, the passage may automatically open as the tip of the infusion needle penetrates the passage, thereby widening and opening the passage. This reduces the risk of material being scraped off the wall by the edge of the injection port opening as the infusion needle advances.

[0234] In a preferred embodiment, the passageway has a flared entrance portion facing the housing, where the passageway is normally open for entry of at least one infusion needle into the passageway during advancement thereof, thereby facilitating insertion of the infusion needle into and through the passageway.

[0235] In other embodiments, the tip of the infusion needle can reside within the passageway when the infusion needle is in the retracted position, thereby avoiding the need to properly feed the infusion needle into the passageway as it is advanced. However, this is only an option for embodiments in which the tip end of the infusion needle is moved forward and backward, but not laterally, during successive infusions.

[0236] Preferably, the passageway is configured as a slit having a longitudinal extension and a widthwise extension through the wall. Such a slit can be compressed by acting on opposite sides of the elastic material in a direction opposite the widthwise extension of the slit to open the slit, thereby opening a passageway for at least one infusion needle as the infusion needle is advanced. In one embodiment, a compressor is operatively connected to the infusion needle and is arranged to compress the slit along its widthwise extension as the infusion needle is advanced.

[0237] Thus, an at least partially implantable system for injecting a substance into a patient's body may be configured as follows: a housing for implantation within a patient's body, the housing having an outer wall with a penetration; at least one infusion needle disposed within the housing; a drive unit arranged to advance and retract the at least one infusion needle in opposite directions so that, upon advancement of the at least one infusion needle, the tip of the at least one infusion needle penetrates said penetration portion and a substance can be injected through said penetration portion via the at least one infusion needle; The penetration part is at least partially made of an elastic material having a pre-configured passage for the passage of at least one infusion needle, the passage being normally closed by an elastic force generated by the elasticity of the elastic material, preferably the passage having an enlarged entrance part that is normally open for the entry of the at least one infusion needle into the passage and / or that automatically opens for the passage of the at least one infusion needle when the infusion needle is advanced, the passage preferably being configured as a slit having a longitudinal extension and a widthwise extension, and the compressor may be provided to act on the opposite side of the elastic material in the direction opposite to the widthwise extension of the slit so as to open the passage for the at least one infusion needle when the infusion needle is advanced.

[0238] Third sub-aspect—rounded or beveled edge needle port According to a third sub-aspect of this further aspect, an infusion needle may be provided, the injection port of which is again provided on its side, here with a rounded or chamfered edge at the transition between the injection port and the side. In other words, the edge surrounding the injection port on the outer surface of the infusion needle may be rounded or chamfered. This reduces the sharpness of the edge, thereby reducing the risk of material being scraped off by the edge of the injection port opening as the infusion needle advances. Preferably, the rounded or chamfered edge is provided on at least opposing side surfaces of the injection port, and an imaginary connecting line between the opposing side surfaces of the injection port extends along the forward and backward directions of the infusion needle. These are the areas of the injection port where material is most likely to be scraped off by the outer edge of the injection port.

[0239] Thus, an at least partially implantable system for injecting a substance into a patient's body may be configured as follows: a housing for implantation within a patient's body, the housing having an outer wall with a penetration; at least one infusion needle disposed within the housing; a drive unit arranged to advance and retract the at least one infusion needle in opposite directions so that, upon advancement of the at least one infusion needle, the tip of the at least one infusion needle penetrates said penetration portion and a substance can be injected through said penetration portion via the at least one infusion needle; - an injection port is provided on at least one side of the injection needle, said injection port having a rounded or chamfered edge at the transition between the injection port and the side, preferably the rounded or chamfered edge is provided on at least opposite side surfaces of the injection port, and an imaginary connecting line between said opposite side surfaces of the injection port extends along the direction of advancement and retraction of the injection needle.

[0240] Fourth embodiment - needle with stylet According to a third aspect of this further aspect, the injection port provided on the side of the infusion needle is omitted. Instead, the injection port is provided in the usual manner on the front surface of the distal end of the infusion needle, and a substance can be ejected from the injection port to the outside of the infusion needle. The stylet is movable within the hollow body of the infusion needle between an advanced position in which the stylet advances within the hollow body to close the injection port and an retracted position in which the stylet retracts within the hollow body to open a path for the substance to pass through the hollow body and exit the injection port, in order to prevent fibrosis from growing within the infusion needle when the infusion needle is placed in a patient.

[0241] The main advantage of a stylet closing the injection port is that it not only prevents fibrosis from growing within the injection needle, but also prevents material from being cut from the penetration area, i.e., the septum or membrane, through which the injection needle passes with its tip as it advances from the retracted position to the advanced position.

[0242] In the advanced position, the stylet may even extend beyond the tip of at least one infusion needle. In other words, because the tip of the stylet is the part that cuts open the insertion area, only the tip of the stylet needs to be sharp, while the tip of the needle body can be blunt. This reduces the risk of tissue damage if the needle remains in the patient's body for a long time.

[0243] In a typical embodiment, the stylet can be retracted from the hollow body of the infusion needle so as to be disengaged from the infusion needle in its retracted position, but it is preferred that the tip of the stylet remain within the hollow body when the stylet is in its fully retracted position to facilitate reinsertion into the infusion needle and to provide a seal against leakage of the drug from the infusion needle when the drug is injected into the patient's body through the infusion needle. For this purpose, a supply port can be provided in the side wall of the hollow body so that a substance can be supplied into the hollow body through the supply port.

[0244] In the embodiments described so far, the distal end of the infusion needle penetrates the penetration site, i.e., membrane, septum, diaphragm, etc., as the infusion needle advances. However, an infusion needle having an injection port on the front side of the distal end of the infusion needle and a stylet inside the hollow body of the infusion needle that closes the injection port to prevent fibrosis from growing inside the infusion needle when the infusion needle is placed in a patient offers additional possibilities in that the needle does not need to be fully retracted into the housing. For example, when the infusion needle is in the retracted position, the tip of the infusion needle may extend from the penetration area. In either case, when the infusion needle is advanced into the patient from such a retracted position, the tip penetrates any fibrosis that may have formed on or in front of the infusion needle. This has the advantage that the force required to penetrate the penetration site is avoided, and therefore the drive for advancing the infusion needle can be dimensioned accordingly smaller.

[0245] If the distal ends of the infusion needles extend from the penetration area when the infusion needles are in the retracted position, the housing may be provided with a protective wall, preferably opposite the distal ends of the infusion needles, to prevent the distal ends from contacting the patient's tissue when at least one infusion needle is in the retracted position. If multiple needles are arranged side by side for multiple punctures of the patient, the distal ends of the infusion needles may be located between two longitudinal walls, for example in a groove provided in the outer surface of the housing.

[0246] Alternatively, if the infusion needles (with their distal ends extending from the penetration region in the retracted position) are displaceable laterally for multiple punctures into the patient, and the penetration region of the outer wall of the housing includes a septum through which the infusion needles extend, the septum may be configured to move laterally along with the at least one infusion needle when the at least one infusion needle is displaced laterally. In this manner, when the infusion needle and the septum are moved laterally to change the injection site, fibrosis formed in both the infusion needle and the septum will move along with the infusion needle and the septum. The protective wall described above for protecting the tip of the infusion needle can also be provided in such cases.

[0247] Thus, an at least partially implantable system for injecting a substance into a patient's body may be configured as follows: a housing for implantation within a patient's body, the housing having an outer wall with a penetration; at least one injection needle arranged in the housing so as to pass through the penetration; the drive unit can be arranged to advance and retract the at least one infusion needle in opposite directions between an advanced position and a retracted position, the system being adapted to inject a substance into the patient's body through the at least one infusion needle when the infusion needle is in the advanced position, and not being able to inject a substance into the patient's body through the at least one infusion needle when the infusion needle is in the retracted position; wherein the injection needle comprises: a tip portion and a hollow body, preferably having a supply port on a side wall of the hollow body so that a substance can be supplied into the hollow body through the supply port, and an injection port on a front surface of the tip portion so that the substance can be discharged out of an injection needle; The stylet is movable within the hollow body between an advanced position and a retracted position, in which the stylet advances within the hollow body to close the injection port and prevent fibrosis from growing within the injection needle when the injection needle is implanted in a patient, and in the retracted position the stylet retracts within the hollow body to open a path for material - preferably from the delivery port - to flow through the hollow body and out the injection port.

[0248] The present disclosure also relates to the styletted infusion needle as such, i.e., system independent, since the principles of the styletted infusion needle may be used in other embodiments of the present disclosure when those embodiments are adapted accordingly. Thus, such an infusion needle comprises a tip portion and a hollow body, a supply port provided in the side wall of the hollow body so that a substance can be supplied into the hollow body through this supply port, and an injection port provided on the front surface of the tip portion so that a substance can be ejected outside the infusion needle through this injection port. In order to prevent fibrosis from occurring within the infusion needle when the infusion needle is placed in a patient, the stylet is movable within the hollow body between an advanced position in which the stylet advances within the hollow body to close the injection port, and a retracted position in which the stylet retracts within the hollow body to close the injection port. In the advanced position of the stylet, the stylet may extend from the tip of the infusion needle, and in this case, the stylet may be sharp so as to penetrate the patient's tissue when the infusion needle is advanced, while the tip of the infusion needle may be blunt.

[0249] Embodiments with a curved needle with a stylet In preferred embodiments, at least the distal portion of the infusion needle, i.e., the portion of the infusion needle that constitutes the distal end of the infusion needle, may be curved in the plane of curvature, i.e., the infusion needle is a curved needle. Curved needles are particularly advantageous in connection with systems for injecting substances into patients that have angled injection needles, as further described above. Some preferred embodiments of the present disclosure relating to at least partially implantable systems for injecting substances into a patient's body comprise such curved needles that further comprise a stylet.

[0250] A system using a curved needle with a stylet can comprise a needle arm to which the infusion needle is attached and a stylet arm to which the stylet is attached, the needle arm and the stylet arm being rotatable about a common axis of rotation. In this manner, the infusion needle and its stylet can be rotated together and / or independently, i.e., advanced and retracted between their respective advanced and retracted positions. A conduit can be connected to the needle arm to supply a substance to the needle. Preferably, the conduit is flexible enough to follow the movement of the needle arm.

[0251] Additionally, the system may include a drive unit for performing at least the following steps in sequence: -advancing the infusion needle and stylet by rotating the needle arm and stylet arm about a common axis of rotation; rotating the stylet arm in a retracting direction about the common rotation axis to retract the stylet within the infusion needle to a retracted position; - The needle arms are rotated in the retracting direction around a common rotation axis to retract the infusion needle. If the infusion needle is retracted into the housing during this series of steps without first reinserting the stylet into the needle body, there is a risk that bodily fluids or blood may drip into the housing from the retracted infusion needle. This is, of course, not a problem in embodiments in which the infusion needle is not completely retracted into the housing, i.e., at least the tip of the infusion needle is not retracted into the housing. However, in at least those embodiments in which the tip end of the infusion needle is also retracted into the housing when the infusion needle returns to its retracted position, the driver is preferably further configured to advance the stylet inside the infusion needle by rotating the stylet arms about a common rotation axis in the forward direction prior to retraction of the infusion needle.

[0252] The drive unit may include a first drive shaft extending from the housing (or casing), the first drive shaft configured to rotate the needle arm and the stylet arm about a common axis of rotation. To ensure that the above sequence of steps is achieved, i.e., that the needle arm and the stylet arm are rotated together at times and independently at other times, certain mechanisms may be provided, such as releasable holders, clutches, cam drives, etc., as described below.

[0253] Preferably, the needle arm and stylet arm are mounted on a carriage that is movable within the housing (or casing) to laterally move the tip of the at least one infusion needle between different lateral positions. In this way, a variety of injection sites 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 within the housing or casing to laterally move the at least one infusion needle between different lateral positions.

[0254] Thus, an at least partially implantable system for injecting a substance into a patient's body, the system comprising a curved needle with a stylet, may be configured as follows: a housing or casing adapted for implantation within a patient's body, the housing or casing having an outer wall with a penetration; at least one infusion needle arranged in the housing or casing to penetrate the penetration area and configured to advance and retract in opposite directions between an advanced position and a retracted position, wherein when the infusion needle is in the advanced position the system is adapted to inject a substance into the patient's body through the at least one infusion needle and when the infusion needle is in the retracted position it is not possible to inject a substance into the patient's body through the at least one infusion needle; - the tip of at least one infusion needle, which is a portion including the tip of at least one infusion needle, is curved within the curvature plane, and the tip is inclined at an angle of 10° to 80° relative to the outer wall; wherein the injection needle comprises: a tip and a hollow body, preferably with a supply port in the side wall of the hollow body so that a substance can be supplied into the hollow body through the supply port, and with an injection port in the front of the tip so that the substance can be dispensed outside the injection needle; The stylet is movable within the hollow body between an advanced position (where the stylet advances within the hollow body to close the injection port and prevent fibrosis from growing within the injection needle when the injection needle is placed in a patient) and a retracted position (where the stylet retracts within the hollow body to open a path for material—preferably from the delivery port—through the hollow body and out the injection port). Here, the system further comprises a needle arm to which the infusion needle is attached and a stylet arm to which the stylet is attached, the needle arm and the stylet arm being rotatable about a common axis of rotation.

[0255] Releasable Holder One mechanism for causing the needle arm and stylet arm to rotate together at times and independently at other times can be a drive device with a biasing element and a releasable holder, as described below.

[0256] The biasing element provides a biasing force that urges the needle arm and the stylet arm apart, while the releasable holder is configured to hold the needle arm and the stylet arm close together against the biasing force of the biasing element. Further, a release is arranged to release the releasable holder when the infusion needle reaches the advanced position or when the advanced position is reached, such that the stylet arm moves away from the needle arm due to the biasing force of the biasing element.

[0257] The biasing element may be a torque spring. However, other biasing elements are possible, such as other types of springs or biasing elements that provide magnetic and / or electromagnetic forces. However, torque springs are preferred due to their simplicity. Preferably, the torque spring has a square or rectangular cross section to provide maximum force in minimum space.

[0258] One end of the torque spring can be attached to the stylet arm and the other end to the needle arm to bias the two arms away from each other. Alternatively, one end of the torque spring can be attached to the stylet arm and the other end to the housing or casing, or, if the needle arm and stylet arm are attached to a carriage that is movable within the housing or casing to move the tip of at least one infusion needle laterally between different lateral positions, the torque spring can be attached to the carriage. In this manner, the stylet arm is connected to the needle arm, and the drive unit moves (rotates) the needle arm to advance the infusion needle into the patient's body. When the stylet arm is then released from the needle arm, the biasing force of the torsion spring allows the needle arm to return to its retracted position, i.e., the toothed stylet moves away from the infusion needle.

[0259] For this purpose, the releasable holder may consist of a flexible hook to which the needle arm and stylet arm are hooked together when the stylet arm rotates in concert with the needle arm about a common axis of rotation in the direction of advancement, while the release portion is a deflector configured to deflect the flexible hook laterally so as to unhook the flexible hook when the infusion needle reaches or has reached its advanced position.

[0260] In this embodiment, in which the driver includes a biasing element and a releasable holder, the infusion needle is retracted into the housing without first reinserting the stylet into the needle body. As previously mentioned, this presents a risk of bodily fluids or blood dripping into the housing from the retracted needle. This is not a problem in embodiments in which the infusion needle is not completely retracted into the housing, i.e., at least the tip of the infusion needle is not retracted into the housing. In at least those embodiments in which the tip of the infusion needle is retracted into the housing when the infusion needle returns to its retracted position, the driver is preferably configured to advance the stylet within the infusion needle by rotating the stylet arm in an advancing direction about a common axis of rotation prior to retraction of the infusion needle. This is achieved in the following embodiments (clutch; cam drive) described below.

[0261] clutch Another mechanism for causing the needle arm and stylet arm to rotate together at times and independently at other times is a drive device with at least one biasing element and a clutch, as described below.

[0262] At least one biasing element can provide a biasing force that urges the stylet arm in cooperation with the needle arm in either an advanced or retracted direction about a common axis of rotation, while a clutch can be configured to selectively couple the drive unit to at least one of the stylet arm, the needle arm, or both the stylet arm and the needle arm. In this manner, both the needle arm and the stylet arm are always biased by the biasing element in the same direction, i.e., toward the retracted position or toward the advanced position. The drive unit can support such movement (rotation) if necessary or at least useful to overcome certain counteracting forces, such as when the tip of an infusion needle penetrates the insertion site. When the two arms reach their end positions, the drive unit can rotate them in opposite directions. Depending on the state of the clutch, the drive device engages the stylet arm (or needle arm) or both the stylet arm and the needle arm, causing one or both of the two arms to move in opposite directions against the biasing force.

[0263] In a preferred embodiment, the at least one biasing element provides a biasing force that urges the stylet arm in an advanced direction in cooperation with the needle arm about a common axis of rotation, and the clutch can be configured to selectively connect the drive unit to the stylet arm to rotate the stylet arm about the common axis of rotation in a retraction direction to retract the stylet within the infusion needle toward its retracted position, or to the needle arm or both the needle arm and the stylet arm to retract the infusion needle by rotating the needle arm about the common axis of rotation in a retraction direction.

[0264] At least one biasing element may comprise a torque spring. However, other biasing elements are possible, such as other types of springs or biasing elements that provide magnetic and / or electromagnetic forces. However, torque springs are preferred due to their simplicity. Preferably, the torque spring has a square or rectangular cross-section to provide maximum force in a minimum space.

[0265] Preferably, one biasing element is provided for each of the needle arm and the stylet arm. For example, if the structure is such that rotation of the stylet arm by a biasing force causes the stylet arm to abut against the needle arm, thereby carrying the needle arm toward the advanced position, a single biasing element acting on the stylet arm may be sufficient. However, a separate biasing element may be provided to bias the needle arm toward the advanced position, i.e., to securely hold the needle arm in the advanced position as the stylet arm retracts the stylet into the hollow body of the infusion needle.

[0266] In this embodiment, in which the drive unit includes a bias element and a clutch, after the stylet is reinserted into the needle body, the infusion needle can be retracted into the housing by rotating the stylet arm in the forward direction about the common rotation axis before the infusion needle is retracted. Therefore, in this case, the bodily fluid is pushed out of the infusion needle by the stylet before the tip of the infusion needle reaches the inside of the housing, so there is no need to worry about residual bodily fluid dropping from the retracted infusion needle into the inside of the housing.

[0267] Cam Drive A further mechanism for allowing the needle arm and stylet arm to rotate together at times and independently at other times is a drive unit with a needle crank arm and a stylet crank arm, as described below.

[0268] The needle crank arm may have one end connected to the needle arm and the other end connected to the needle guide path, such that movement of the needle crank arm along the needle guide path and rotation of the needle arm about a common axis of rotation are interdependent. Meanwhile, the stylet crank arm may have one end connected to the stylet arm and the other end connected to the stylet guide path, such that movement of the stylet crank arm along the stylet guide path and rotation of the stylet arm about a common axis of rotation are interdependent. In this manner, by independently moving the needle crank arm and the stylet crank arm, the positions of the infusion needle and its stylet can be accurately determined at any given time. That is, as the needle crank arm moves along the needle guide path, the needle arm must rotate around a common axis of rotation to follow. Similarly, as the stylet crank arm moves along the stylet guide path, the stylet arm must rotate around a common axis of rotation to follow.

[0269] The movement of each of the needle crank arm and the stylet crank arm can be controlled individually and timely. To this end, the drive unit may further include at least one cam that defines a needle cam path and a stylet cam path. The needle crank arm may be connected to the needle cam path, for example, by a first cam follower, such that movement of the cam rotates the needle arm about a common axis of rotation, while the stylet crank arm may be connected to the stylet cam path, for example, by a second cam follower, such that rotation of the cam rotates the stylet arm about the common axis of rotation. The needle cam path and the stylet cam path may be in the form of grooves or ridges along which the cam followers are forced to move.

[0270] Preferably, at least one cam is in the form of a cam disc rotatable about a central axis. Thus, the needle arm and stylet arm can each be urged to rotate about a common axis of rotation simply by rotating at least one cam disc. That is, the needle and stylet crank arms engage the needle and stylet cam paths and are forced to move along these paths, particularly by their cam followers, so that rotation of the cam disc or discs causes movement of the crank arms, and consequently movement (rotation), of the needle arm and stylet arm to which they are connected. Preferably, a single cam disc is provided that defines both the needle cam path and the stylet cam path, so that only one cam needs to be actuated to advance and retract the infusion needle and its stylet, respectively.

[0271] Preferably, the needle arm and stylet arm are mounted on a carriage that is movable within the housing or casing to move the tip of at least one infusion needle laterally between different lateral positions, where the carriage may be rotatably mounted within the housing or casing, i.e., such lateral movement of the distal end of the infusion needle is actually movement about a common axis of rotation.

[0272] Other Aspects - Pop Rivet A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed implantable drug delivery system and that is configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; and a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a second portion configured to be disposed through a hole in the tissue portion extending between the first side and the second side of the tissue portion. a connecting portion configured to connect the first portion to the second portion, the connecting portion having a third cross-sectional area in a third plane, the connecting portion configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, and to prevent the first and second portions from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes; the connecting portion and the second portion configured to form a connecting interface between the connecting portion and the second portion, the second portion extending along a first direction parallel to the second plane, the second portion having a longitudinal cross-sectional area along the first direction, the second longitudinal cross-sectional area being smaller than the first longitudinal cross-sectional area, and the first longitudinal cross-sectional area being located closer to the connecting interface with respect to the first direction.

[0273] In some embodiments, the second portion has a first end and a second end opposite the first end along the first direction, the second portion has a length between the first end and the second end, the second portion has an intermediate region and a distal region, the intermediate region is defined by a connection interface between the connecting portion and the second portion, and the distal region extends from the connection interface between the connecting portion and the second portion to the second end.

[0274] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the second end.

[0275] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the second end.

[0276] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the second end.

[0277] In some embodiments, the distal region of the second portion is conical.

[0278] In some embodiments, the second portion has rotational symmetry along the first direction.

[0279] In some embodiments, the second surface of the second portion is substantially perpendicular to the central extension of the connecting portion.

[0280] In some embodiments, the second surface of the second portion is substantially parallel to the second plane.

[0281] In some embodiments, the second surface of the second portion is substantially flat and configured to form a contact area against the second tissue surface, and the second portion further comprises a lower surface facing away from the first portion configured to taper toward the second end.

[0282] In some embodiments, the second portion has a proximal region that extends from the first end to a connection interface between the connecting portion and the second portion.

[0283] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the first end.

[0284] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the first end.

[0285] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the mid-region toward the first end.

[0286] In some embodiments, the proximal region of the second portion is conical.

[0287] In some embodiments, the first end and the second end each comprise an elliptical point.

[0288] In some embodiments, the first and second ends each include a hemispherical end cap.

[0289] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0290] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0291] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0292] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0293] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0294] In some embodiments, the connection interface between the connecting portion and the second portion is eccentric relative to the second portion in a first direction but not in a second direction perpendicular to the first direction.

[0295] In some embodiments, the connection interface between the connection portion and the second portion is off-center relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0296] In some embodiments, the second direction is parallel to a second plane.

[0297] In some embodiments, the proximal and distal regions comprise a second surface configured to engage a second surface of a second side of the tissue portion.

[0298] In some embodiments, the second portion tapers from the first end to the second end.

[0299] In some embodiments, the second portion tapers from an intermediate region of the second portion to each of the first and second ends.

[0300] In some embodiments, the first portion has a maximum dimension in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0301] In some embodiments, the first portion has a diameter in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0302] 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, for example in the range of 5 to 10 mm.

[0303] In some embodiments, the second portion has a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 35 to 60 mm.

[0304] 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 flattened disk shape.

[0305] 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.

[0306] In some embodiments, the distal region is configured to face downward in a standing patient.

[0307] 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, and the first height being less than the second height.

[0308] 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.

[0309] In some embodiments, the second end of the second portion comprises a connection portion for connecting to an implant located caudally from the location of the implantable, energized medical device within the patient.

[0310] In some embodiments, the first end of the second portion comprises a connection portion for connecting to an implant located cranially from the location of the implantable, energized medical device within the patient.

[0311] In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second, and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0312] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0313] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0314] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0315] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0316] In some embodiments, the second portion comprises a second wireless energy receiver.

[0317] In some embodiments, the first portion comprises a first energy storage unit.

[0318] In some embodiments, the second portion comprises a second energy storage unit.

[0319] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0320] In some embodiments, the solid state battery is a thionyl chloride battery.

[0321] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0322] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0323] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0324] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0325] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0326] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0327] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0328] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0329] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0330] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0331] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0332] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0333] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0334] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0335] In some embodiments, the second portion comprises at least one electric motor.

[0336] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion produced by the electric motor.

[0337] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0338] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0339] In some embodiments, the transmission comprises a gear system.

[0340] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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 surrounding at least the second portion.

[0341] In some embodiments, the second portion comprises at least one hydraulic pump, which may include, be embodied as, or include a piezoelectric motor.

[0342] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0343] In some embodiments, the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor being configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0344] In some embodiments, at least one of the first and second portions comprises a sensation generator adapted to generate a sensation detectable by the patient's senses.

[0345] In some embodiments, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0346] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit force from the second portion to the implant engaging portion.

[0347] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted body engaging portion.

[0348] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0349] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0350] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0351] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of a patient.

[0352] In some embodiments, the walls of the first chamber are resilient to allow expansion of the first chamber.

[0353] In some embodiments, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuable implantable element configured to exert a force on a body part of the patient, and a second hydraulic system in fluid communication with a second hydraulically actuable implantable element configured to exert a force on a body part of the patient, wherein the first and second hydraulically actuable implantable elements are adjustable independently of each other.

[0354] In some embodiments, the first hydraulic system comprises a first hydraulic pump, which may include a piezoelectric motor, be embodied as a piezoelectric pump, or include a piezoelectric pump, and the second hydraulic system comprises a second hydraulic pump, which may include a piezoelectric motor, be embodied as a piezoelectric pump, or include a piezoelectric pump.

[0355] In some embodiments, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0356] 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.

[0357] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0358] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0359] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0360] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed implantable drug delivery system and that is configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; and a second portion configured to be disposed on a second side of the tissue portion, the second side facing 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 on the second side of the tissue portion; and a connecting rod configured to be disposed through an opening in the tissue portion extending between the first and second sides of the tissue portion. a connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface on a first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area such that the first portion, the second portion, and the connecting portion are prevented from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the first portion configured to receive electromagnetic waves at a frequency above a frequency level and / or transmit electromagnetic waves at a frequency below a frequency level, and the second portion configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level, the frequency level being 100 kHz.

[0361] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0362] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency above the frequency level to an external device.

[0363] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0364] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0365] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter at a higher frequency level and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion at a lower frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter at the lower frequency level.

[0366] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0367] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0368] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device above the frequency level, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion below the frequency level.

[0369] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion at or below the frequency level.

[0370] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0371] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0372] In some embodiments, the second portion comprises an outer casing made of titanium.

[0373] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0374] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed implantable drug delivery system and that is configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing 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 on the second side of the tissue portion. a connecting portion configured to be positioned through a hole in the tissue portion extending between a first side and a second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, so that the first portion, the second portion, and the connecting portion are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; and the first portion configured to receive and / or transmit electromagnetic waves at a frequency less than a frequency level, the frequency level being 100 kHz.

[0375] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0376] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency equal to or less than the frequency level to the second portion.

[0377] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to an external device.

[0378] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0379] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0380] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter below a frequency level, and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion below a frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter below a frequency level.

[0381] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0382] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0383] 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 at a frequency level below, and 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 at a frequency level below.

[0384] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion at or below the frequency level.

[0385] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0386] In some embodiments, the first portion comprises an outer casing made of titanium.

[0387] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0388] In some embodiments, the second portion comprises an outer casing made of titanium.

[0389] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0390] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed implantable drug delivery system and that is configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing 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 on the second side of the tissue portion. a connecting portion configured to be positioned through an opening in the tissue portion extending between the first side and the second side, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, so as to prevent the first portion, the second portion, and the connecting portion from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the first portion made from a polymeric material and the second portion comprised of a casing made from titanium, the casing forming a complete housing.

[0391] In some embodiments, the casing of the second part forms a complete enclosure when the second part is connected to the connecting part, such that the entire outer surface of the second part is covered by the casing.

[0392] In some embodiments, the first portion comprises a casing made from a polymeric material.

[0393] In some embodiments, the casing of the first part forms a complete enclosure such that the entire outer surface of the first part is covered by the casing.

[0394] In some embodiments, the connecting portion comprises a connector that connects to the first portion and the second portion, respectively, and is arranged to transmit electrical signals and / or energy.

[0395] In some embodiments, the joint is disposed in the joint core such that it is sealed by the outer material of the joint.

[0396] In some embodiments, the coupling portion comprises a ceramic material.

[0397] In some embodiments, the connections are encapsulated in a ceramic material.

[0398] In some embodiments, the first portion comprises a first connecting portion configured to connect to a connecting portion of the connecting portion.

[0399] In some embodiments, the second portion comprises a second connecting portion configured to connect to the connecting portion of the connecting portion.

[0400] In some embodiments, the casing of the second part is hermetically sealed.

[0401] In some embodiments, the second connection is positioned such that the hermetic seal of the second portion remains intact.

[0402] In some embodiments, the casing of the first portion is sealed.

[0403] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed implantable drug delivery system and that is configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed 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 comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion. a connecting portion having a third surface configured to engage a first tissue surface on one side, the connecting portion configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another, the third cross-sectional area is smaller than the second cross-sectional area, and the first, second, and connecting portions are prevented from moving through holes in the tissue portions in directions perpendicular to the first, second, and third planes; the connecting portion is configured to extend between the first and second portions along a central extension axis, and the second portion is configured to extend in a length direction diverging from the central extension axis; the connecting portion has a substantially constant cross-sectional area along the central extension axis or the connecting portion has a cross-sectional area that decreases in a direction from the first portion to the second portion along the central extension axis, and / or the second portion has a substantially constant cross-sectional area along the length direction or the second portion has a cross-sectional area that decreases in the length direction.

[0404] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0405] In some embodiments, the connecting portion tapers along the central extension axis in a direction from the first portion to the second portion.

[0406] In some embodiments, the connecting portion has a circular or elliptical cross-section along the central elongate axis that decreases in diameter in a direction from the first portion to the second portion.

[0407] In some embodiments, the second portion is tapered in its length.

[0408] In some embodiments, the connecting portion has a circular or elliptical cross section that decreases in diameter along its length.

[0409] In some embodiments, the length direction extends from the interface between the connecting portion and the second portion toward an end of the second portion.

[0410] In some embodiments, the length direction extends substantially perpendicular to the central elongation axis.

[0411] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed implantable drug delivery system, where a medical device configured to be held in place by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and configured to engage a second tissue surface on the second side of the tissue portion. a second portion having a second surface; a connecting portion configured to be positioned through an opening in the tissue portion extending between a first side and a second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane, the connecting portion configured to connect the first portion to the second portion; and an airtight seal arrangement configured to surround the connecting portion to prevent fluid from the patient from entering the connecting portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, so as to prevent the first and second portions from moving through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes, and the connecting portion comprises a flexible structure that allows the connecting portion to flex.

[0412] In some embodiments, the flexible structure is configured to allow the linking portion to flex in multiple directions.

[0413] In some embodiments, the flexible structure is configured to allow the linking portion to flex in any direction.

[0414] In some embodiments, the flexible structure comprises a bellows.

[0415] In some embodiments, the bellows is a metal bellows.

[0416] In some embodiments, the metal bellows is welded.

[0417] In some embodiments, the bellows is a titanium bellows.

[0418] In some embodiments, the bellows forms part of a hermetic seal arrangement.

[0419] In some embodiments, the flexible structure comprises a lift portion that allows said deflection of the linking portion.

[0420] In some embodiments, the lifting portion is configured to allow the linking portion to be compressed and / or expanded.

[0421] In some embodiments, the flexible structure has a substantially cylindrical shape.

[0422] In some embodiments, the flexible structure is configured to seal against the first portion and / or the second portion.

[0423] In some embodiments, the connecting portion and the second portion are hermetically sealed from the first portion.

[0424] In some embodiments, the hermetic seal arrangement surrounds the connecting portion and the second portion so as to hermetically seal the connecting portion and the second portion from the first portion.

[0425] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0426] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0427] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0428] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0429] In some embodiments, the solid state battery is a thionyl chloride battery.

[0430] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0431] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0432] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0433] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0434] In some embodiments, the first controller is connected in the first portion to a first wireless communication receiver for receiving wireless communication from an external device;

[0435] The first controller is connected to the first wireless communication transmitter of the first portion for transmitting wireless communications to the second wireless communication receiver of the second portion.

[0436] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0437] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0438] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0439] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0440] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0441] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0442] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0443] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0444] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0445] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0446] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0447] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0448] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0449] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0450] In some embodiments, the first end and the second end each comprise an elliptical point.

[0451] In some embodiments, the first and second ends each include a hemispherical end cap.

[0452] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0453] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0454] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0455] In some embodiments, the implantable energized medical device further comprises a gear arrangement and an electric motor, the gear arrangement configured to slow down and increase the force of the motion produced by the electric motor.

[0456] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0457] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0458] In some embodiments, the gear arrangement comprises a gear system.

[0459] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion.

[0460] In some embodiments, the second portion comprises at least one hydraulic pump, which may include, be embodied as, or include a piezoelectric motor.

[0461] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0462] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through an aperture in the tissue portion extending between the first and second sides of the tissue portion. the connecting portion has a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another, and the third cross-sectional area is smaller than the first and second cross-sectional areas, and is configured to prevent the first and second portions from moving through an opening 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 the unit to a second end of the unit, wherein the first end is proximal to the first portion and the second end is distal to the first portion, and wherein the physical footprint of the unit perpendicular to the central axis decreases continuously or in a stepwise manner from the first end to the second end of the unit.

[0463] In some embodiments, the physical footprint comprises a cross-sectional area perpendicular to a central axis.

[0464] In some embodiments, the linking portion and the second portion are either configured to reversibly link to each other to form the unit, or configured to irreversibly link to each other to form the unit, or configured as a single body to form the unit.

[0465] In some embodiments, the unit comprises a corner that forms a bend in the unit.

[0466] In some embodiments the bend is between 15° and 165°, such as between 30° and 150°, such as between 45° and 135°, for example substantially 90°.

[0467] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0468] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0469] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0470] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0471] In some embodiments, the solid state battery is a thionyl chloride battery.

[0472] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0473] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0474] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0475] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0476] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0477] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0478] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0479] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0480] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0481] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0482] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0483] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0484] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0485] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0486] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0487] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0488] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0489] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0490] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0491] In some embodiments, the first end and the second end each comprise an elliptical point.

[0492] In some embodiments, the first and second ends each include a hemispherical end cap.

[0493] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0494] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0495] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0496] In some embodiments, the implantable energized medical device further comprises a gear arrangement and an electric motor, the gear arrangement configured to slow down and increase the force of the motion produced by the electric motor.

[0497] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0498] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0499] In some embodiments, the gear arrangement comprises a gear system.

[0500] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion.

[0501] In some embodiments, the second portion comprises at least one hydraulic pump, which may include, be embodied as, or include a piezoelectric motor.

[0502] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0503] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through an opening 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 connecting the first portion to the the first, second, and third planes are parallel to one another, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the connecting portion is configured to extend between the first and second portions along a central extension axis, and the second portion is configured to extend in a longitudinal direction diverging from the central extension axis, the connecting portion having a cross-sectional area that decreases in a direction from the first portion to the second portion along the central extension axis, the maximum cross-sectional area of ​​the second portion in the longitudinal direction being smaller than the minimum cross-sectional area of ​​the connecting portion in the direction from the first portion to the second portion along the central extension axis; and the second portion further having a cross-sectional area that decreases in the longitudinal 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.

[0504] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a first surface configured to face a second tissue surface on the second side of the tissue portion. a second surface configured to engage the surface; a connecting portion configured to be positioned through a hole in the tissue portion extending between a first side and a second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane, the connecting portion configured to connect the first portion to the second portion; and an electric motor, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area so as to prevent the first portion and the second portion from moving through the hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane, and at least a portion of the electric motor is disposed within the connecting portion.

[0505] In some embodiments, the electric motor is disposed within the linkage portion within an imaginary boundary defined by a first surface of the first portion extending through the linkage portion.

[0506] In some embodiments, the electric motor is disposed within the coupling portion within an imaginary boundary defined by a second surface of the second portion extending through the coupling portion.

[0507] In some embodiments, the electric motor is disposed entirely within the coupling portion within an imaginary boundary defined by a first surface of the first portion extending through the coupling portion and a second surface of the second portion extending through the coupling portion, respectively.

[0508] In some embodiments, the electric motor is positioned such that its longest dimension extends in a direction substantially perpendicular to the first, second and third cross-sectional areas.

[0509] In some embodiments, the electric motor is positioned such that its longest dimension extends in a direction between the first portion and the second portion.

[0510] In some embodiments, the worm drive is configured to transmit mechanical power from the electric motor to an implantable body-engaging portion that is external to the implantable, energized medical device.

[0511] In some embodiments, the electric motor extends through the coupling portion to the first portion and / or the second portion.

[0512] In some embodiments, the electric motor extends through an imaginary boundary defined by a first surface of the first portion that extends through the coupling portion.

[0513] In some embodiments, the electric motor extends through an imaginary boundary defined by a second surface of the second portion that extends through the coupling portion.

[0514] In some embodiments, the electric motor extends through an imaginary boundary defined by a first surface of a first portion extending through the connecting portion and a second surface of a second portion extending through the connecting portion, respectively.

[0515] In some embodiments, the implantable energized medical device further comprises a gear arrangement operably coupled to the electric motor, the gear arrangement being partially or completely disposed in one of the first portion and the second portion.

[0516] In some embodiments, the gear arrangement is disposed within the linkage portion within an imaginary boundary defined by a first surface of the first portion extending through the linkage portion.

[0517] In some embodiments, the gear arrangement is disposed within the coupling portion within an imaginary boundary defined by a second surface of the second portion extending through the coupling portion.

[0518] In some embodiments, the gear arrangement is disposed entirely within the coupling portion within an imaginary boundary defined by a first surface of the first portion extending through the coupling portion and a second surface of the second portion extending through the coupling portion, respectively.

[0519] In some embodiments, the gear arrangement extends through the linking portion to the first portion and / or the second portion.

[0520] In some embodiments, the gear arrangement extends through an imaginary boundary defined by a first surface of the first portion that extends through the coupling portion.

[0521] In some embodiments, the gear arrangement extends through an imaginary boundary defined by a second surface of the second portion that extends through the coupling portion.

[0522] In some embodiments, the gear arrangement extends through an imaginary boundary defined by a first surface of the first portion extending through the connecting portion and a second surface of the second portion extending through the connecting portion, respectively.

[0523] In some embodiments, the gear arrangement is configured to transmit mechanical power from the electric motor to an implantable body-engaging portion external to the implantable energized medical device.

[0524] In some embodiments, the gear arrangement is or consists of a worm drive.

[0525] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0526] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0527] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0528] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0529] In some embodiments, the solid state battery is a thionyl chloride battery.

[0530] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0531] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0532] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0533] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0534] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0535] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0536] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0537] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0538] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0539] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0540] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0541] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0542] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0543] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0544] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0545] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0546] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0547] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0548] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0549] In some embodiments, the first end and the second end each comprise an elliptical point.

[0550] In some embodiments, the first and second ends each include a hemispherical end cap.

[0551] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0552] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0553] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0554] In some embodiments, the gear arrangement is configured to slow down the speed and increase the force of the motion produced by the electric motor.

[0555] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0556] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0557] In some embodiments, the gear arrangement comprises a gear system.

[0558] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion.

[0559] In some embodiments, the second portion comprises at least one hydraulic pump, which may include, be embodied as, or include a piezoelectric motor.

[0560] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0561] In accordance with one embodiment of the present concept, there is provided an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first surface configured to face a first tissue surface on the first side of the tissue portion, the first portion further configured to connect, directly or indirectly, to a second portion positioned on a second side of the tissue portion opposite the first side, the first portion comprising an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion.

[0562] In some embodiments, the first portion is configured to connect to the second portion, directly or indirectly, via a connecting portion configured to extend through a hole in the tissue portion, the hole extending between a first side of the tissue portion and a second side of the tissue portion.

[0563] In some embodiments, the implantable energized medical device further comprises a connecting portion.

[0564] In some embodiments, the connecting portion is integrally formed with the first portion.

[0565] In some embodiments, the linking portion is a separate component with respect to the first portion, and the linking portion is configured to be coupled to the first portion.

[0566] 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, the first and second planes being parallel to one another, and the second cross-sectional area being smaller than the first cross-sectional area, such that the first and second portions are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first and second planes.

[0567] In some embodiments, the first portion is configured to removably connect, directly or indirectly, to the second portion.

[0568] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter.

[0569] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0570] In some embodiments, the first energy storage unit is a solid-state battery.

[0571] In some embodiments, the solid state battery is a thionyl chloride battery.

[0572] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, and the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver of the second part.

[0573] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0574] In some embodiments, the first controller is connected to a wireless transceiver for wireless communication with an external device.

[0575] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0576] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0577] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0578] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0579] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion such that the flange is prevented from moving through the hole in the tissue portion, and such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is detached from the connecting portion.

[0580] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0581] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side. a tissue portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is greater than the first and second cross-sectional areas. the first and second cross-sectional areas of the body-engaging implant being smaller than the first and second cross-sectional areas and configured to prevent movement of the first and second portions through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes; an implantable energy storage unit configured to at least one of stretch, contract, expand, stimulate, and exert a force on the body tissue or body organ; an implantable reservoir configured to hold a fluid; an implantable pump that includes a piezoelectric motor or is embodied as a piezoelectric pump or may include a piezoelectric pump, and is configured to transfer fluid between the implantable reservoir and the body-engaging implant via a conduit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate the implantable pump; wherein the implantable energy storage unit, the implantable reservoir, the implantable pump, and the implantable electric motor are disposed external to the implantable energized medical device.

[0582] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be disposed 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 configured to connect the first and second portions; and a connecting portion configured to be disposed on the first portion, the connecting portion, or the second portion. the body-engaging implant comprises an implantable energy storage unit connected to the implantable energy storage unit; wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, and wherein the first and second portions are configured to be prevented from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; an implantable reservoir configured to hold a fluid; an implantable pump that may include, be embodied as, or may include a piezoelectric motor, and that is configured to transfer fluid through a conduit to the implantable reservoir and the body-engaging implant, respectively; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate the implantable pump; wherein the implantable reservoir, the implantable pump, and the implantable electric motor are located external to the implantable energized medical device.

[0583] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be positioned 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 configured to connect the first and second portions; an implantable energy storage unit configured to hold a fluid; and an implantable pump that may include a piezoelectric motor, be embodied as a piezoelectric pump, or may include a piezoelectric pump, and that is configured to transfer fluid between the implantable reservoir and the body-engaging implant via a conduit; wherein the implantable electric motor is connected to the implantable energy storage unit and configured to operate the implantable pump, and the implantable energy storage unit, the implantable reservoir, and the implantable pump are located external to the implantable energized medical device.

[0584] A system is provided, comprising an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side and the second part having a first surface. a second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed through an aperture 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 configured to connect the first portion to the second portion; and an implantable reservoir configured to hold a fluid, the implantable reservoir being disposed in the first portion, the connecting portion, or the second portion; In the following, we provide a body-engaging implant, the first, second, and third planes being parallel to one another, the third cross-sectional area being smaller than the first and second cross-sectional areas, and configured to prevent the first and second portions from moving through a hole in the tissue portion in a direction perpendicular to the first, second, and third planes, the body-engaging implant configured to perform at least one of stretching, contracting, expanding, stimulating, and biasing on the body tissue or body organ; an implantable energy storage unit; an implantable pump including, or embodied as, a piezoelectric motor, or which may include a piezoelectric pump, configured to transfer fluid between a reservoir and the body-engaging implant via a conduit, respectively; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate the implantable pump; wherein the implantable energy storage unit, the implantable pump, and the implantable electric motor are disposed external to the implantable energized medical device.

[0585] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a a second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed through an aperture 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 configured to connect the first portion to the second portion; and an implantable pump disposed on the first portion, the connecting portion, or the second portion, the pump including a piezoelectric motor or being embodied as a piezoelectric pump. or a piezoelectric pump, wherein the first, second, and third planes are parallel to one another, and the third cross-sectional area is smaller than the first and second cross-sectional areas, and the third cross-sectional area is adapted to prevent the first and second portions from moving through an opening 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 energize a body tissue or body organ; an implantable energy storage unit and an implantable reservoir configured to hold a fluid; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid between the implantable reservoir and each of the body-engaging implants via a conduit, and the implantable energy storage unit, the implantable reservoir, and the implantable electric motor are located external to the implantable energized medical device.

[0586] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned 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 including a second surface configured to engage a second tissue surface on the second side of the tissue portion. a connecting portion configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas and configured to prevent the first and second portions from moving through a hole in the tissue portion in a direction perpendicular to the first, second, and third planes; a body-engaging implant configured to perform at least one of stretching, contracting, expanding, stimulating, and exerting a force on a body tissue or body organ; an implantable energy storage unit; and an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to actuate the body-engaging implant; wherein the implantable energy storage unit and the implantable electric motor are disposed external to the implantable energized medical device.

[0587] A system is provided, comprising an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side and the second portion having a first surface configured to face a second tissue surface of the first side of the tissue portion. a second portion having a second cross-sectional area in a third plane and including a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed through an opening in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion; an implantable energy storage unit disposed on the first portion, the connecting portion, or the second portion; an implantable electric motor coupled to an implantable energy storage unit, wherein first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, and wherein the body-engaging implant is configured to prevent the first and second portions from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; an implantable reservoir configured to hold a fluid with the body-engaging implant configured to at least one of stretch, contract, expand, stimulate, and exert a force on a body tissue or body organ; and an implantable pump that may include a piezoelectric motor, be embodied as a piezoelectric pump, or include a piezoelectric pump, and configured to transfer fluid to the implantable reservoir and the body-engaging implant, respectively, via a conduit; wherein the implantable electric motor is configured to operate the implantable pump, and the implantable reservoir and implantable pump are located external to the implantable energized medical device.

[0588] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side and the second surface facing the first side. the second portion has a second cross-sectional area in a second plane and includes a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed 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 configured to connect the first portion to the second portion; an implantable reservoir configured to hold a fluid disposed in the first portion, the connecting portion, or the second portion; an implantable electric motor disposed in the first portion, the connecting portion, or the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, and wherein the body-engaging implant is configured to prevent the first and second portions from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the body-engaging implant and an implantable energy storage unit configured to perform at least one of stretching, contracting, expanding, stimulating, and biasing on the body tissue or body organ; and an implantable pump that includes a piezoelectric motor, is embodied as a piezoelectric pump, or may include a piezoelectric pump, and is configured to transfer fluid between the implantable reservoir and the body-engaging implant via a conduit, respectively; the implantable electric motor is connected to the implantable energy storage unit and configured to operate the implantable pump, and the implantable energy storage unit and the implantable pump are disposed external to the implantable energized medical device.

[0589] A system is provided, comprising an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a first surface. a second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed through an aperture 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 configured to connect the first portion to the second portion; and an implantable reservoir configured to hold a fluid, the implantable reservoir being disposed in the first portion, the connecting portion, or the second portion. an implantable reservoir disposed in the first portion, the connecting portion, or the second portion; an implantable pump disposed in the first portion, the connecting portion, or the second portion, the implantable pump including, being embodied as, or including a piezoelectric motor; a body-engaging implant, the first, second, and third planes being parallel to one another, the third cross-sectional area being smaller than the first and second cross-sectional areas, and configured to prevent the first and second portions from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the body-engaging implant, configured to at least one of stretch, contract, expand, stimulate, and exert a force on a 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 configured to operate the implantable pump; wherein the implantable pump is configured to transfer fluid between each of the implantable reservoir and the body-engaging implant via a conduit;and an implantable electric motor, wherein the implantable energy storage unit and the implantable electric motor are located external to the implantable energized medical device;

[0590] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be disposed 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 configured to connect the first portion to the second portion; an implantable pump disposed in the first part, the connecting part or the second part, the implantable pump including a piezoelectric motor, being embodied as a piezoelectric pump, or including a piezoelectric pump; an implantable energy storage unit disposed in the first part, the connecting part or the second part, the body-engaging implant having first, second and third planes parallel to one another and a third cross-sectional area smaller than the first and second cross-sectional areas, the body-engaging implant configured to prevent movement of the first part and the second part through an opening in the tissue part in a direction perpendicular to the first, second and third planes; an implantable reservoir configured to hold a fluid with the body-engaging implant configured to at least one of stretch, contract, expand, stimulate and bias a body tissue or a body organ; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor 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 the implantable reservoir and the implantable electric motor are located external to the implantable energized medical device;

[0591] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed 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 configured to connect the first portion to the second portion. a connecting portion configured to connect to the first portion; an implantable electric motor disposed on the first portion, the connecting portion, or the second portion, wherein the first, second, and third planes are parallel to each other and the third cross-sectional area is smaller than the first and second cross-sectional areas so as to prevent the first and second portions from moving through a hole in the tissue portion in a direction perpendicular to the first, second, and third planes; a body-engaging implant configured to perform at least one of stretching, contracting, expanding, stimulating, and exerting a force on a body tissue or body organ; an implantable energy storage unit; an implantable energy storage unit connected to the implantable energy storage unit, the implantable electric motor configured to operate the body-engaging implant, the implantable energy storage unit being disposed external to the implantable energized medical device.

[0592] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be disposed through a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and connecting the first portion to a hole in the tissue portion; an implantable energy storage unit configured to couple to the second portion; an implantable energy storage unit disposed in the first portion, the coupling portion, or the second portion; an implantable electric motor disposed in the first portion, the coupling portion, or the second portion, the implantable electric motor coupled to the implantable energy storage unit; and an implantable reservoir configured to hold a fluid, the implantable reservoir disposed in the first portion, the coupling portion, or the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, so as to prevent the first and second portions from moving through the opening 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 energize a body tissue or a body organ;, an implantable pump that includes, is embodied as, or may include a piezoelectric motor and is configured to transfer fluid through a conduit to an implantable reservoir and a body-engaging implant, respectively; , an implantable electric motor configured to operate the implantable pump, the implantable pump being located external to the implantable energized medical device;

[0593] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a a second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed through an aperture 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 configured to connect the first portion to the second portion; an implantable reservoir configured to hold a fluid disposed in the first portion, the connecting portion, or the second portion; an implantable electric motor disposed in the second portion; and an implantable pump disposed in the first portion, the connecting portion, or the second portion, the implantable pump including a piezoelectric motor, embodied as a piezoelectric pump, or which may include a piezoelectric pump, wherein the first, second, and third planes are parallel to one another, the third cross-sectional area is smaller than the first and second cross-sectional areas, and the first and second portions are configured to be prevented from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the body-engaging implant and an implantable energy storage unit configured to perform at least one of stretching, contracting, expanding, stimulating, and energizing on a body tissue or a body organ, the implantable energy storage unit configured to transfer fluid to the implantable reservoir and the body-engaging implant, respectively, via a conduit; the implantable electric motor connected to the implantable energy storage unit and configured to operate the implantable pump;an implantable energy storage unit, wherein the implantable energy storage unit is located external to the implantable energized medical device;

[0594] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing 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 on the second side of the tissue portion; a connecting portion configured to be disposed 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 configured to connect the first portion to the second portion; and an implantable reservoir configured to hold a fluid, the implantable reservoir configured to be disposed 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 on the first side of the tissue portion; an implantable reservoir disposed in the first portion, the connecting portion, or the second portion; an implantable pump, which may include a piezoelectric motor, be embodied as a piezoelectric pump, or include a piezoelectric pump, and which is disposed in the first portion, the connecting portion, or the second portion; and an implantable energy storage unit, which is disposed in the first portion, the connecting portion, or the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, and the body-engaging implant is configured to prevent the first and second portions from moving in a direction perpendicular to the first, second, and third planes through an opening in the tissue portion; and an implantable electric motor connected to the body-engaging implant and the implantable energy storage unit, configured to perform at least one of stretching, contracting, expanding, stimulating, and energizing on a body tissue or a body organ, the implantable electric motor being configured to operate the implantable pump;an implantable electric motor, wherein the implantable pump is configured to transfer fluid between the implantable reservoir and each of the body-engaging implants via a conduit; and an implantable electric motor, wherein the implantable electric motor is disposed external to the implantable energized medical device;

[0595] A system is provided, comprising an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side and the second portion having a first surface configured to face a second tissue surface of the first side of the tissue portion. a second portion having a second cross-sectional area in a third plane and including a second surface configured to engage a second tissue surface on a second side of the tissue portion; a connecting portion configured to be disposed through an opening in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion; and an implantable device disposed on the first portion, the connecting portion, or the second portion, which may include a piezoelectric motor, be embodied as a piezoelectric pump, or may include a piezoelectric pump. a body-engaging implant, comprising: an implantable pump; an implantable energy storage unit disposed in the first portion, the connecting portion, or the second portion; and an electric motor disposed in the first portion, the connecting portion, or the second portion, wherein the first, second, and third planes are parallel to one another, the third cross-sectional area is smaller than the first and second cross-sectional areas, and the first and second portions are configured to prevent movement of the body-engaging implant through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; an implantable reservoir configured to hold a fluid with the body-engaging implant, the body-engaging implant configured to at least one of stretch, contract, expand, stimulate, and bias the body tissue or body organ; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate the implantable pump; and the implantable pump configured to transfer fluid to and from the implantable reservoir and the body-engaging implant, respectively, via a conduit, the implantable reservoir being disposed external to the implantable energized medical device.

[0596] A system is provided, comprising an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed 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 on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed 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. a connecting portion configured to connect the first portion to the second portion; an implantable energy storage unit disposed on the first portion, the connecting portion, or the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas so as to prevent the first and second portions from moving through a 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 a body tissue or body organ; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate the body-engaging implant; wherein the implantable electric motor is disposed external to the implantable energized medical device.

[0597] 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.

[0598] In some embodiments, the implantable energized medical device further comprises a second wireless communication transmitter disposed in the second portion, the second wireless communication transmitter configured to transmit a communication signal to the first wireless communication receiver.

[0599] In some embodiments, the implantable energized medical device further comprises a first wireless communication transmitter disposed in the first portion, the first wireless communication transmitter configured to transmit a communication signal outside the patient's body.

[0600] In some embodiments, the implantable energized medical device further comprises a second wireless communication receiver disposed in the second portion, and the first wireless communication transmitter is configured to transmit a communication signal to the second wireless communication receiver.

[0601] In some embodiments, the implantable energized medical device further comprises a wireless energy receiver configured to receive wirelessly transmitted energy from outside the patient's body and deliver the received energy to the implantable energy storage unit.

[0602] 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.

[0603] In some embodiments, the implantable electric motor is operably connected to the implantable pump via a rotatable shaft.

[0604] In some embodiments, the implantable electric motor is operatively connected to the implantable pump via a magnetic coupling.

[0605] In some embodiments, the system further comprises a gear arrangement disposed within the implantable energized medical device and operably connected to the electric motor, the gear arrangement configured to reduce the speed and increase the force of movement generated by the electric motor.

[0606] In some embodiments, the system further comprises a gear arrangement disposed external to the implantable energized medical device and operably connected to the electric motor, the gear arrangement configured to reduce the speed and increase the movement force generated by the electric motor.

[0607] In some embodiments, the system further includes a housing configured to enclose at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0608] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0609] In some embodiments, the system further includes a housing configured to enclose at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0610] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0611] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0612] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0613] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0614] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0615] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0616] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0617] In some embodiments, the first end and the second end each comprise an elliptical point.

[0618] In some embodiments, the first and second ends each include a hemispherical end cap.

[0619] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0620] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0621] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0622] In some embodiments, the system further includes a gear arrangement configured to decrease the speed and increase the force of the motion generated by the electric motor.

[0623] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0624] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0625] In some embodiments, the gear arrangement comprises a gear system.

[0626] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion.

[0627] In some embodiments, the pump is a hydraulic pump. The hydraulic pump may include, be implemented as, or include a piezoelectric motor.

[0628] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0629] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be disposed through an opening in the tissue portion extending between the first side and the second side of the portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first and second portions are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the first portion configured to be disposed subcutaneously in the patient, the first portion including a connection interface arrangement for transmitting wired energy and / or wired communication signals and / or fluid to an additional implant in the patient.

[0630] In some embodiments, the 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.

[0631] In some embodiments, the connection interface arrangement comprises a port for transferring fluid from the first portion to said additional implant.

[0632] In some embodiments, the implantable energized medical device further comprises at least one conduit or tube for transporting said fluid, the at least one conduit or tube being connected to the port.

[0633] In some embodiments, the implantable energized medical device further comprises at least one wire for energy and / or communication signals connected to the connection interface arrangement.

[0634] In some embodiments, the height of the first portion is the maximum height.

[0635] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0636] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0637] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0638] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0639] In some embodiments, the solid state battery is a thionyl chloride battery.

[0640] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0641] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0642] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0643] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0644] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0645] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0646] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0647] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0648] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0649] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0650] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0651] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0652] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0653] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0654] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0655] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0656] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0657] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0658] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0659] In some embodiments, the first end and the second end each comprise an elliptical point.

[0660] In some embodiments, the first and second ends each include a hemispherical end cap.

[0661] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0662] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0663] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0664] In some embodiments, the implantable energized medical device further comprises a gear arrangement and an electric motor, the gear arrangement configured to slow down and increase the force of the motion produced by the electric motor.

[0665] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0666] In some embodiments, the gear arrangement is configured to convert rotational force into linear force.

[0667] In some embodiments, the gear arrangement comprises a gear system.

[0668] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion.

[0669] In some embodiments, the second portion comprises at least one hydraulic pump, which may include, be embodied as, or include a piezoelectric motor.

[0670] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0671] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned 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 on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion. and a connecting portion configured to be positioned through an opening in the tissue portion extending between the first side and the second side, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, such that the first portion and the second portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the first portion and the second portion are configured to be positioned subcutaneously in a patient, such that an implantable energized medical device can be positioned with either the first portion or the second portion positioned on the first side of the tissue portion.

[0672] In some embodiments, the 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.

[0673] In some embodiments, the first portion has a length in a plane parallel to the first plane, and the second portion has a length in a plane parallel to the second plane, and the length of the first portion differs from the length of the second portion by no more than 30%, e.g., when the length of the first portion differs from the length of the second portion by no more than 15%, e.g., when the length of the first portion differs from the length of the second portion by no more than 5%, e.g., when the length of the first portion differs from the length of the second portion by no more than 1%.

[0674] In some embodiments, the first portion has a width in a plane parallel to the first plane, and the second portion has a width in a plane parallel to the second plane, and the width of the first portion differs from the width of the second portion by no more than 30%, e.g., when the width of the first portion differs from the width of the second portion by no more than 15%, e.g., when the width of the first portion differs from the width of the second portion by no more than 5%, e.g., when the width of the first portion differs from the width of the second portion by no more than 1%.

[0675] In some embodiments, the first portion has a height in a plane perpendicular to the first plane, and the height of the first portion differs from the height of the second portion by 30% or less, e.g., the height of the first portion differs from the height of the second portion by 15% or less, e.g., the height of the first portion differs from the height of the second portion by 5% or less, e.g., the height of the first portion differs from the height of the second portion by 1% or less.

[0676] In some embodiments, the 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.

[0677] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0678] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0679] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0680] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0681] In some embodiments, the solid state battery is a thionyl chloride battery.

[0682] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0683] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0684] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0685] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0686] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0687] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0688] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0689] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0690] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0691] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0692] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0693] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0694] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0695] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0696] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0697] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0698] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0699] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0700] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0701] In some embodiments, the first end and the second end each comprise an elliptical point.

[0702] In some embodiments, the first and second ends each include a hemispherical end cap.

[0703] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0704] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0705] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0706] In some embodiments, the implantable energized medical device further comprises a gear arrangement and an electric motor, the gear arrangement configured to slow down and increase the force of the motion produced by the electric motor.

[0707] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0708] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0709] In some embodiments, the gear arrangement comprises a gear system.

[0710] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion.

[0711] In some embodiments, the second portion comprises at least one hydraulic pump, which may include a piezoelectric motor, be embodied as a piezoelectric pump, or include a piezoelectric pump.

[0712] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0713] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed 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 second plane. an implantable, energized medical device comprising: a connecting portion having a third cross-sectional area in a plane and configured to connect the first portion to the second portion, the second portion comprising or forming a reservoir for holding a fluid; a sealed container further comprising the implantable, energized medical device and configured to protrude into the reservoir; and an actuator connected to the sealed container, the actuator configured to expand or contract the sealed container to change a volume of the sealed container to pump fluid to or from the reservoir; wherein: the first, second, and third planes are parallel to one another; the third cross-sectional area is smaller than the first and second cross-sectional areas; and the first and second portions are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0714] In some embodiments, the actuator comprises an electric motor.

[0715] In some embodiments, the actuator is located at the linkage.

[0716] In some embodiments, the actuator is located partially or completely within the enclosed enclosure.

[0717] In some embodiments, the second portion includes a port in fluid communication with the reservoir for transferring fluid between the reservoir and an additional implant within the patient.

[0718] In some embodiments, the implantable energized medical device further comprises a conduit connected to the port, the conduit configured to transfer fluid between the reservoir and the additional implant.

[0719] In some embodiments, the implantable energized medical device further comprises an injection port for introducing a fluid, the injection port being located in the first portion.

[0720] In some embodiments, the implantable energized medical device further comprises an internal conduit connecting the injection port to the reservoir.

[0721] In some embodiments, the enclosure is a bellows.

[0722] In some embodiments, the bellows is a metal bellows.

[0723] In some embodiments, at least a portion of the enclosed vessel configured to contact the fluid comprises a metal.

[0724] In some embodiments, the volume of the enclosed container can be varied such that the volume of the enclosed container is 60% or more of the maximum volume of the reservoir.

[0725] In some embodiments, the sealed container includes at least one flexible portion, the flexible portion allowing for at least one of compression and expansion of the sealed container.

[0726] In some embodiments, the sealed container includes at least one resilient portion, the resilient portion allowing for at least one of compression and expansion of the sealed container.

[0727] In some embodiments, the implantable energized medical device further comprises a first energy storage unit and / or a second energy storage unit for providing power to the actuator.

[0728] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0729] In some embodiments, the first energy storage unit is connected to the first wireless energy receiver.

[0730] In some embodiments, the second portion comprises a second energy storage unit, the second energy storage unit connected to a second wireless energy receiver.

[0731] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0732] In some embodiments, the solid state battery is a thionyl chloride battery.

[0733] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted 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 the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0734] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0735] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0736] In some embodiments, the first controller and / or the second controller are configured to control the actuator.

[0737] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0738] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0739] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0740] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0741] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0742] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0743] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0744] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0745] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0746] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0747] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0748] In some embodiments, the connecting portion includes a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, thereby allowing the second portion and the connecting portion to be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0749] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0750] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0751] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0752] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0753] In some embodiments, the first end and the second end each comprise an elliptical point.

[0754] In some embodiments, the first and second ends each include a hemispherical end cap.

[0755] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0756] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0757] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0758] In some embodiments, the implantable energized medical device further comprises a gear arrangement configured to slow down and increase the force of the motion produced by the electric motor.

[0759] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0760] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0761] In some embodiments, the gear arrangement comprises a gear system.

[0762] In some embodiments, the second portion comprises a magnetic coupling for transmitting 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, and a housing surrounding at least the second portion. [Brief explanation of the drawings]

[0763] The invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 shows the entire system of the present disclosure implanted in a patient's body according to a first variant. [Figure 2] FIG. 2 shows the entire system of the present disclosure implanted in a patient's body according to a second variant. [Figure 3] FIG. 3 is a first general concept showing how the penetration area can be penetrated by an infusion needle at different penetration sites. [Figure 4] FIG. 4 is a second general concept showing how an insertion site can be penetrated by an infusion needle at different insertion sites. [Figure 5] 5A and 5B are a front view and a rear view, respectively, of the drive device according to the first embodiment. [Figure 6]6A and 6B are a front view and a rear view, respectively, of the drive device according to the first embodiment. [Figure 7] FIG. 7 shows a needle cooperating member of a drive device according to a first embodiment to which an infusion needle is attached. [Figure 8] 8 is a perspective view of the needle cooperation member and base of FIG. 7. FIG. [Figure 9] 9A and 9B are a front view and a rear view, respectively, of the drive unit according to the second embodiment. [Figure 10] 10A and 10B are a front view and a rear view, respectively, of the drive unit according to the second embodiment. [Figure 11] 11A and 11B are a front view and a rear view, respectively, of a drive unit according to a third embodiment. [Figure 12] 12A and 12B are a front view and a rear view, respectively, of a drive unit according to a third embodiment. [Figure 13] FIG. 13 shows a needle cooperating member of a drive device according to a third embodiment, which comprises two separable parts. [Figure 14] FIG. 14 is a diagram showing an alignment structure of a driving device according to the third embodiment. [Figure 15] FIG. 15 is a diagram showing injection of a substance into a vein using the driving device according to the third embodiment. [Figure 16A] FIG. 16A generally illustrates a system for communicating with an implanted medical device. [Figure 16B] FIG. 16B generally illustrates a system for communicating with an implanted medical device. [Figure 16B] FIG. 16B' generally illustrates a system for communicating with an implanted medical device. [Figure 16C] FIG. 16C generally illustrates a system for communicating with an implanted medical device. [Figure 17] FIG. 17 illustrates one embodiment of a system for charging, programming, and communicating with a controller of an implantable medical device. [Figure 18] Figure 18 is an elevated perspective view from the left side of the housing unit. [Figure 19] FIG. 19 is a plan view of the housing as seen from the left. [Figure 20] Figure 20 is an elevated perspective view from the left side of the housing unit. [Figure 21] FIG. 21 is a plan view of the housing from the left side. [Figure 22] FIG. 22 shows an outline of a system of an external device that has a housing and a display device for wireless communication with an implantable medical device. [Figure 23] FIG. 23 shows an implant having a coating disposed on the surface of the implant. [Figure 24] FIG. 24 shows an implant with multiple coatings on the implant surface. [Figure 25A] FIG. 25A shows different micropatterns applied to the surface of the implant. [Figure 25B] FIG. 25B shows different micropatterns applied to the surface of the implant. [Figure 26] FIG. 26 is a flow chart of a method for implanting the system. [Figure 27] FIG. 27 illustrates one embodiment of an implantable energized medical device. [Figure 28] FIG. 28 illustrates one embodiment of an implantable energized medical device. [Figure 29A] FIG. 29A shows the first portion and connecting portion of the medical device of FIGS. [Figure 29B] FIG. 29B shows the first portion and connecting portion of the medical device of FIGS. [Figure 29C] FIG. 29C shows the first portion and connecting portion of the medical device of FIGS. [Figure 29D] FIG. 29D shows the first portion and connecting portion of the medical device of FIGS. [Figure 30A] FIG. 30A shows a modification of the elements of the connecting portion of FIGS. 29A to 29C. [Figure 30B]FIG. 30B shows a modification of the elements of the connecting portion of FIGS. 29A to 29C. [Figure 31A] FIG. 31A shows a modification of the elements of the connecting portion of FIGS. 29A to 29C. [Figure 31B] FIG. 31B shows a modified example of the elements of the connecting portion of FIGS. 29A to 29C. [Figure 32A] FIG. 32A shows a modification of the elements of the connecting portion of FIGS. 29A to 29C. [Figure 32B] FIG. 32B shows a modified example of the elements of the connecting portion of FIGS. 29A to 29C. [Figure 33] FIG. 33 shows a kit for assembling the medical device of FIGS. [Figure 34] FIG. 34 shows a further embodiment of an implantable energized medical device. [Figure 35] FIG. 35 shows a typical example of an implantable energized medical device. [Figure 36] FIG. 36 shows a first variant of the general embodiment of the medical device of FIG. [Figure 37] FIG. 37 shows a second variant of the general embodiment of the medical device of FIG. [Figure 38A] FIG. 38A shows a cross section of the medical device of FIG. [Figure 38B] FIG. 38B shows a cross section of the medical device of FIG. [Figure 39A] 39A shows a different relative arrangement of the first and second parts of the medical device of FIG. [Figure 39B] FIG. 39B illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39C] FIG. 39C illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39D] FIG. 39D illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39E] FIG. 39E illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39F]FIG. 39F illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39G] FIG. 39G illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39H] FIG. 39H illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39I] FIG. 39I illustrates a different relative arrangement of the first and second parts of the medical device of FIG. [Figure 39J] FIG. 39J illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39K] FIG. 39K illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39M] FIG. 39M illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39N] FIG. 39N illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39P] FIG. 39P illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39Q] FIG. 39Q illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 40] FIG. 40 shows a third variant of the general embodiment of the medical device of FIG. [Figure 41] FIG. 41 shows a third variant of the general embodiment of the medical device of FIG. [Figure 42] FIG. 42 shows the medical device of FIG. 35 with its first and second portions at different rotational displacements relative to one another. [Figure 43] FIG. 43 shows the medical device of FIG. 35 with its first and second portions at different rotational displacements relative to one another. [Figure 44A] FIG. 44A illustrates the procedure for inserting the medical device of FIGS. [Figure 44B]FIG. 44B illustrates the procedure for inserting the medical device of FIGS. [Figure 44C] FIG. 44C illustrates the procedure for inserting the medical device of FIGS. [Figure 45] FIG. 45 shows a further embodiment of an implantable energized medical device. [Figure 46A] FIG. 46A shows a gear arrangement and magnetic coupling for coupling an implantable energized medical device to an implant. [Figure 46B] FIG. 46B shows a gear arrangement and magnetic coupling for coupling an implantable energized medical device to an implant. [Figure 47A] FIG. 47A is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 47B] FIG. 47B shows a longitudinal cross section of the implantable medical device along line AA in FIG. 47A. [Figure 47C] FIG. 47C shows a longitudinal cross section of the implantable medical device along line AA in FIG. 47A. [Figure 48] FIG. 48 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 49] FIG. 49 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 50] FIG. 50 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 51A] FIG. 51A is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 51B] FIG. 51B shows a longitudinal cross-sectional area of ​​the implantable medical device along line AA in FIG. 51A. [Figure 51C] FIG. 51C shows a longitudinal cross-sectional area of ​​the implantable medical device along line AA in FIG. 51A. [Figure 52] FIG. 52 is a cross-sectional plan view of one embodiment of an implantable energized medical device. [Figure 53A] FIG. 53A is a cross-sectional planar side view of one embodiment of an implantable energized medical device. [Figure 53B] FIG. 53B is a cross-sectional planar side view of one embodiment of an implantable energized medical device. [Figure 53C] FIG. 53C is a cross-sectional planar side view of one embodiment of an implantable energized medical device. [Figure 54A] FIG. 54A is a cross-sectional planar side view of the embodiment of FIGS. 53A-53C as inserted into a tissue portion. [Figure 54B] FIG. 54B is a cross-sectional planar side view of the embodiment of FIGS. 53A-53C as inserted into a tissue portion. [Figure 54C] FIG. 54C is a cross-sectional planar side view of the embodiment of FIGS. 53A-53C as inserted into a tissue portion. [Figure 54D] FIG. 54D is a cross-sectional planar side view of the embodiment of FIGS. 53A-53C as inserted into a tissue portion. [Figure 55A] FIG. 55A is a cross-sectional planar side view of an embodiment of an implantable energized medical device. [Figure 55B] FIG. 55B is a cross-sectional planar side view of an embodiment of an implantable energized medical device. [Figure 55C] FIG. 55C is a cross-sectional planar side view of an embodiment of an implantable energized medical device. [Figure 55D] FIG. 55D is a cross-sectional planar side view of an embodiment of an implantable energized medical device. [Figure 55E] FIG. 55E is a cross-sectional planar side view of an embodiment of an implantable energized medical device. [Figure 55F] FIG. 55F is a cross-sectional planar side view of an embodiment of an implantable energized medical device. [Figure 56] FIG. 56 shows an embodiment of an implantable energized medical device for providing power to a...

Claims

1. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing adapted to be implanted in a patient's body, the housing having an outer wall with a penetration region; at least one injection needle arranged in the housing so as to pass through the penetration; a drive unit arranged for advancing and retracting the at least one infusion needle in opposite directions between an advanced position and a retracted position, the drive unit being adapted for injecting a substance into the body of a patient through the at least one infusion needle when the infusion needle is in the advanced position, and for injecting a substance into the body of a patient through the at least one infusion needle when the infusion needle is in the retracted position; Equipped with at least one of at least one piezoelectric motor and at least one piezoelectric pump; system.

2. at least one piezoelectric motor comprises a piezoelectric inchworm motor; The system of claim 1 .

3. At least one piezoelectric motor comprises a piezoelectric inertia motor. The system of claim 2.

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

5. the piezoelectric motor is a linear piezoelectric motor; A system according to any one of claims 2 to 4.

6. The linear piezoelectric motor operates on at least one of the following: - speeds ranging from 1 mm / s to 10 mm / s, - a stroke length ranging from 4 mm to 30 mm, and Forces in the range of -2N to 30N, The system of claim 5.

7. The piezoelectric motor is a rotary piezoelectric motor A system according to any one of claims 2 to 4.

8. The piezoelectric motor is a rotary piezoelectric motor that operates by at least one of the following: rotation speeds in the range of -1 mrad / s to 100 mrad / s, and Torque in the range of -100Nmm to 900Nmm, 6. A system according to any one of claims 2 to 5.

9. At least one piezoelectric motor comprises a piezoelectric ultrasonic motor. The system of claim 2.

10. Piezoelectric ultrasonic motors are traveling wave ultrasonic motors The system of claim 9.

11. The piezoelectric ultrasonic motor is a standing wave ultrasonic motor; The system of claim 9.

12. The piezoelectric ultrasonic motor is a rotary piezoelectric ultrasonic motor that operates in at least one of the following ways: a rotation speed in the range of -10 mrad / s to 10,000 mrad / s, and Torque range from -20Nmm to 450Nmm, 12. A system according to any one of claims 9 to 11.

13. The piezoelectric ultrasonic motor is a linear piezoelectric ultrasonic motor operating in at least one of the following ways: - a speed in the range of 4 mm / s to 100 mm / s, - a stroke length ranging from 4 mm / s to 30 mm, and Forces in the range of -5N to 30N 12. A system according to any one of claims 9 to 11.

14. the at least one piezoelectric motor comprises at least one bimorph piezoelectric actuator; 14. A system according to any one of claims 2 to 13.

15. at least one piezoelectric motor is substantially non-magnetic; A system according to any one of claims 2 to 14.

16. at least one piezoelectric motor is substantially non-metallic; 16. A system according to any one of claims 2 to 15.

17. at least one piezoelectric motor is a reversible piezoelectric motor; 17. A system according to any one of claims 2 to 16.

18. At least one piezoelectric motor forms part of the drive unit; 18. A system according to any one of claims 2 to 17.

19. at least one piezoelectric pump is provided for injecting a substance into the patient's body through the at least one infusion needle when the infusion needle is in the advanced position; 19. A system according to any one of claims 1 to 18.

20. at least one piezoelectric pump is provided for injecting a substance into the patient's body through the at least one infusion needle when the infusion needle is in the advanced position; 20. The system of claim 19.

21. a piezoelectric pump comprising a first wall, a first diaphragm, a first chamber, and a driving element; The first diaphragm and the first wall enclose a first chamber. the first wall 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 flex in response to operation of the drive element; The drive element consists of a piezoelectric actuator or is adapted to be actuated by a piezoelectric motor 21. A system according to claim 19 or 20.

22. the inlet of the first wall comprises an inlet valve, and the outlet of the first wall comprises an outlet valve; 22. The system of claim 21.

23. Either the inlet valve of the first wall portion or the outlet valve of the first wall portion is a check valve or an active valve.

23. The system of claim 22.

24. The check valve is a ball valve 24. The system of claim 23.

25. the inlet of the first wall comprises an inlet static element and the outlet of the first wall comprises an outlet static element, wherein either the inlet static element or the outlet static element is configured to act as a nozzle or a diffuser; 22. The system of claim 21.

26. The first diaphragm constitutes the first movable wall portion.

24. A system according to any one of claims 21 to 23.

27. the first movable wall portion comprises a raised portion and a lowered portion, the raised portion and the lowered portion capable of at least one of compression and expansion to move the first movable wall portion; 27. The system of claim 26.

28. the first movable wall portion comprises a substantially rigid portion; 28. The system of claim 27.

29. the first movable wall portion comprises a bellows; 29. A system according to any one of claims 26 to 28.

30. The bellows is made of metal.

30. The system of claim 29.

31. the bellows having at least one of an elliptical cross section, an elliptical cross section, and a circular cross section; 31. The system of claim 30.

32. Piezoelectric pumps also - Auxiliary wall and - an auxiliary chamber sealed from the first chamber Equipped with wherein the auxiliary wall and the first diaphragm enclose the auxiliary chamber.

32. A system according to any one of claims 21 to 31.

33. Piezoelectric pumps also - Auxiliary wall an auxiliary chamber sealed from the first chamber; an auxiliary diaphragm configured to bend in the same direction as the first diaphragm upon operation of the drive element; Equipped with an auxiliary wall and an auxiliary diaphragm surrounding the auxiliary chamber; 32. A system according to any one of claims 21 to 31.

34. the auxiliary chamber is configured to be connected to a pressure adapter that allows for variation of pressure within the auxiliary chamber; 34. A system according to claim 32 or 33.

35. the pressure adapter comprises a resilient portion having a surface area, the resilient portion configured to maintain substantially the same surface area while allowing for fluctuations in pressure within the auxiliary chamber; 34. The system of claim 33.

36. the piezoelectric pump further comprising a second wall, a second diaphragm, and a second chamber; a second diaphragm and a second wall enclosing a second chamber; the second wall 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 drive element; 32. A system according to any one of claims 21 to 31.

37. an inlet of the second wall portion forming an inlet valve and an outlet of the second wall portion forming an outlet valve; 37. The system of claim 36.

38. Either the inlet valve of the second wall portion or the outlet valve of the second wall portion is a check valve or an active valve; 38. The system of claim 37.

39. The check valve is a ball valve, 37. The system of claim 36.

40. an inlet of the second wall portion defining an inlet stationary element and an outlet of the second wall portion defining an outlet stationary element, wherein either the inlet stationary element or the outlet stationary element is configured to act as a nozzle or a diffuser; 37. The system of claim 36.

41. The piezoelectric pump comprises at least two sections connected in series, each section being a piezoelectric pump according to any one of claims 21 to 35.

36. A system according to any one of claims 21 to 35.

42. 41. The piezoelectric pump comprises at least two sections connected in series, each section being a piezoelectric pump according to any one of claims 36 to 40.

41. A system according to any one of claims 36 to 40.

43. The piezoelectric pump comprises at least two sections connected in parallel, each section being a piezoelectric pump according to any one of claims 21 to 35.

36. A system according to any one of claims 21 to 35.

44. 41. A piezoelectric pump comprising at least two sections connected in parallel, each section being a piezoelectric pump according to any one of claims 36 to 40.

41. A system according to any one of claims 36 to 40.

45. a controller configured to control the piezoelectric pump; 45. A system according to any one of claims 21 to 44.

46. 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 a feedback unit. the feedback unit is configured to send a conditioning signal to the controller based on the measured parameters received from the sensors and based on the setpoint values ​​of the parameters; the controller is configured to adjust the control of the piezoelectric pump based on the adjustment signal received from the feedback unit so that the measured parameter achieves the setpoint; 22. The system of claim 21.

47. The parameters of the piezoelectric pump measured by the sensor comprise at least a flow rate or a pressure; 47. The system of claim 46.

48. 1. An at least partially implantable system for injecting a substance into a patient's body, preferably comprising: - a housing (12) or casing adapted for implantation in a patient's body, said housing (12) or casing having an outer wall with a penetration area (14); - placed in the housing (12) or casing so as to pass through the penetration area (14) at least one injection needle (11) configured to advance and retract in opposite directions between an advanced position and a retracted position, the system being adapted to inject a substance into the patient's body through the at least one injection needle (11) when the injection needle (11) is in the advanced position and being unable to inject a substance into the patient's body through the at least one injection needle (11) when the injection needle (11) is in the retracted position; The infusion needle (11) is inclined with respect to the outer wall by an inclination angle (α) within the range of 10° to 80°.

48. A system according to any one of claims 1 to 47.

49. The inclination angle (α) is in the range of 20° to 40°.

49. The system of claim 48.

50. a driver arranged to advance and retract the at least one infusion needle in opposite forward and retraction directions between an advanced position and a retracted position; 50. A system according to claim 48 or 49.

51. When the at least one infusion needle (11) advances, the tip (11C) of the at least one infusion needle (11) penetrates the penetration region (14).

51. A system according to any one of claims 48 to 50.

52. When the at least one infusion needle (11) is in its retracted position, a distal end (11C) of the at least one infusion needle (11) extends from the penetration region (14); 51. A system according to any one of claims 48 to 50.

53. The housing (12) is provided with a protective wall (12B), preferably opposite the distal end (11C) of the at least one infusion needle (11), to prevent the distal end (11C) from contacting the patient's tissue when the at least one infusion needle (11) is in its retracted position.

53. The system of claim 52.

54. At least one infusion needle (11) is displaceable laterally, and the penetration (14) in the outer wall of the housing forms a partition through which the at least one infusion needle (11) extends, and when the at least one infusion needle (11) is displaced laterally, the partition is movable laterally together with the at least one infusion needle (11).

54. A system according to claim 52 or 53.

55. the outer wall of the housing (12) has an outer surface (12A) extending in a first direction, and the longitudinal container (V) is configured so that it can be placed adjacent to the outer surface (12A) so that the central axis (AV) of the longitudinal container (V) extends parallel to the first direction, and the direction of advancement and retreat of at least one injection needle (11) is arranged in a plane defined by the first direction and the central axis (AV) of the longitudinal container (V), at an inclination angle (α) in the range of 10° to 80° with respect to the first direction, 55. A system according to any one of claims 48 to 54.

56. the first direction varies along a curve; 56. The system of claim 55.

57. a holder (20) configured to hold the container (V) in place such that a central axis (AV) of the container (V) extends parallel to a first direction of the outer surface (12A) of the outer wall of the housing when the at least one injection needle (11) is advanced; 57. A system according to claim 55 or 56.

58. The holder (20) is configured to surround a portion of the container (V) in the longitudinal direction so that the container (V) cannot escape from the holder (20).

58. The system of claim 57.

59. the holder (20) comprises a movable lid (21) configured to open and close the holder (20) for placing and holding the portion of the longitudinal container (V) in the holder (20); 59. A system according to claim 57 or 58.

60. The tip end portion of at least one infusion needle (11), which is a portion including the tip end portion (11C) of at least one infusion needle (11), is curved within a plane of curvature.

60. A system according to any one of claims 48 to 59.

61. The advancement and retraction of the at least one infusion needle (11) in the advancement and retraction directions is performed by rotating the tip end portion of the at least one infusion needle (11) about a rotation axis (11E) perpendicular to the plane of curvature.

61. The system of claim 60.

62. The injection needle (11) consists of: a tip (11C) and a hollow body, preferably having a supply port (11D) in the side wall of the hollow body, through which a substance can be supplied into the hollow body, and an injection port (11A) in front of the tip (11C), through which a substance can be expelled outside the injection needle (11), and a stylet (99) movable within the hollow body between an advanced position (where the stylet (99) advances within the hollow body to close the injection port (11A) and prevent fibrosis from growing within the infusion needle (11) when the infusion needle (11) is placed in a patient) and a retracted position (where the stylet (99) retracts within the hollow body to open a path for substances to pass through the hollow body and out the injection port (11A)); 62. A system according to claim 60 or 61.

63. In the advanced position of the stylet (99), the stylet (99) extends from the distal end (11C) of the injection needle (11).

63. The system of claim 62.

64. The tip (99C) of the stylet (99) is sharp to penetrate the patient's tissue when the infusion needle (11) is advanced.

64. The system of claim 63.

65. The tip (11C) of the infusion needle (11) is blunt.

65. The system of claim 64.

66. The device comprises a needle arm (11F) to which an infusion needle (11) is attached, and a stylet arm (99F) to which a stylet (99) is attached, and the needle arm (11F) and the stylet arm (99F) are rotatable around a common rotation axis (11E).

66. A system according to any one of claims 62 to 65.

67. a conduit connected to the needle arm (11F) for supplying the substance to the injection needle (11), preferably - the conduit is flexible so that it can follow the movement of the needle arm (11F); 67. The system of claim 66.

68. A drive unit is provided to carry out the following steps in sequence: - advancing the infusion needle (11) and stylet (99) by rotating the needle arm (11F) together with the stylet arm (99F) about a common axis of rotation (11E) in the forward direction; - retracting the stylet (99) in the infusion needle (11) towards its retracted position by rotating the stylet arm (99F) in the retracting direction about the common axis of rotation (11E); - retracting the infusion needle (11) by rotating the needle arm (11F) in the retracting direction about a common axis of rotation (11E); 68. A system according to claim 66 or 67.

69. The drive unit is configured to perform the following steps before retracting the infusion needle (11): - Advancement of the stylet (99) within the infusion needle (11) by rotating the stylet arm (99F) about a common axis of rotation (11E) in the direction of advancement.

69. The system of claim 68.

70. a first drive shaft (45) extending from the housing (12) or casing, the first drive shaft (45) configured to rotate the needle arm (11F) and the stylet arm (99F) about a common axis of rotation (11E); 70. A system according to any one of claims 66 to 69.

71. The needle arm (11F) and stylet arm (99F) are mounted on a carriage (46) movable within the housing (12) or casing to move the distal end (11C) of at least one infusion needle (11) laterally between different lateral positions.

71. A system according to any one of claims 66 to 70.

72. A second drive shaft (44) extends from the housing (12) or casing, the second drive shaft (44) configured to move a carriage (46) within the housing (12) or casing to laterally move the distal end (11C) of the at least one infusion needle (11) between different lateral positions.

72. The system of claim 71.

73. The drive unit is - a biasing element (41) for biasing the needle arm (11F) and the stylet arm (99F) away from each other; a releasable holder (42) configured to hold the needle arm (11F) and the stylet arm (99F) in close proximity to one another against a biasing force; and a release portion (43) arranged to release the releasable holder (42) so that, when the infusion needle (11) reaches the advanced position, the stylet arm (99F) moves away from the needle arm (11F) under the biasing force of the biasing element (41); 73. A system according to any one of claims 68 to 72.

74. The biasing element (41) is a torque spring.

74. The system of claim 73.

75. The torque spring has a square or rectangular cross section; 75. The system of claim 74.

76. One end of the torque spring is attached to the stylet arm (99F), and the other end of the torque spring is attached to the needle arm (11F).

76. A system according to claim 74 or 75.

77. One end of the torque spring is attached to the stylet arm (99F) and the other end of the torque spring is attached to the housing (12) or casing, or the needle arm (11F) and the stylet arm (99F) are attached to a carriage (46) that is movable within the housing (12) or casing so as to move the distal end (11C) of the infusion needle (11) laterally between different lateral positions.

76. A system according to claim 74 or 75.

78. the releasable holder (42) comprises a flexible hook that hooks together the needle arm (11F) and the stylet arm (99F) when the stylet arm (99F) rotates together with the needle arm (11F) about a common rotation axis (11E) in the forward direction, and the release portion (43) is a deflector configured to deflect the flexible hook laterally so as to disengage the flexible hook when or if the infusion needle (11) reaches the forward position; 78. A system according to any one of claims 73 to 77.

79. The drive unit consists of: - at least one biasing element providing a biasing force for biasing the stylet arm (99F) in cooperation with the needle arm (11F) in a forward or backward direction about a common axis of rotation (11E); a stylet arm (99F), a needle arm (11F), and a clutch configured to selectively connect at least one of the stylet arm (99F) and the needle arm (11F) to a drive device; 73. A system according to any one of claims 68 to 72.

80. At least one biasing element provides a biasing force that urges the stylet arm (99F) in cooperation with the needle arm about a common axis of rotation (11E) in an advancement direction, and a clutch is configured to selectively connect the drive unit to the stylet arm (99F). configured to selectively connect with the needle arm (11F) or with both the needle arm (11F) and the stylet arm (99F) to retract the stylet (99) in the injection needle (11) towards its retracted position by rotating the stylet arm (99F) in the retraction direction about a common axis of rotation (11E), or to retract the injection needle (11) by rotating the needle arm (11F) in the retraction direction about a common axis of rotation (11E), 80. The system of claim 79.

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

82. The torque spring has a square or rectangular cross section; 81. The system of claim 80.

83. A biasing element is provided on each of the needle arm (11F) and the stylet arm (99F).

83. A system according to any one of claims 80 to 82.

84. The drive unit a needle crank arm (11G) connected at one end to the needle arm (11F) and at its other end to the needle guide channel (11H) such that the movement of the needle crank arm (11G) along the needle guide channel (11H) and the rotation of the needle arm (11F) about a common axis of rotation (11E) are interdependent; a stylet crank arm (99G) connected at one end to the stylet arm (99F) and at its other end to the stylet guide path (99H) such that the movement of the stylet crank arm (99G) along the stylet guide path (99H) and the rotation of the stylet arm (99F) about a common axis of rotation (11E) are interdependent; 73. A system according to any one of claims 68 to 72.

85. the drive device further comprises at least one cam consisting of a needle cam path (11J) and a stylet cam path (99J); - the needle crank arm (11G) is connected to the needle cam path (11J) so that the movement of the cam rotates the needle arm (11F) about a common axis of rotation (11E); - the stylet crank arm (99G) is connected to the stylet cam path (99J) such that rotation of the cam causes the stylet arm (99F) to rotate about a common axis of rotation (11E); 85. The system of claim 84.

86. At least one cam is a cam disc (49) rotatable about a central axis; 86. The system of claim 85.

87. the needle arm (11F) and the stylet arm (99F) are mounted on a carriage (46) that is movable within the housing (12) or casing so as to move the distal end (11C) of the infusion needle (11) laterally between different lateral positions, the carriage (46) being rotatably mounted within the housing (12) or casing; 87. The system of claim 86.

88. 88. A method of implanting at least one component of a system for injecting a substance according to any one of claims 1 to 87 into a patient's body, comprising: - Making an incision in the skin ablating at least one site within the patient's body; - placing a housing containing at least one infusion needle in the dissected area so that the tip of the at least one infusion needle penetrates the patient's tissue when penetrating the outer wall of the housing, allowing the injection of a substance through the at least one penetration area via the at least one infusion needle; - Closing at least the skin after implantation of at least part of the system Including, method.

89. The method further includes disposing one or more of the following components of the system within the patient's body separate from the housing containing the at least one infusion needle: - at least part of the drive unit (D), - Reservoir - pump (P), at least one motor (M, M2) for operating one or more elements of the drive, pump (P) or other energy-consuming part of the system; - energy storage means (A) for supplying energy to at least one motor; - a galvanic coupling element between an external energy source (E) or energy storage means (A) and the motor (M, M2), a wireless coupling element adapted to connect the motor (M, M2) and / or the energy storage means (A) to an external primary energy source for contactless energy transmission to the motor and / or the energy storage means; - a control unit (C1) for controlling the motors (M, M2), a data transmission interface for wirelessly transmitting data from an external data processing device (C2) to the control device (C1); - feedback sensor (F), - Wireless energy conversion means - an injection port for refilling the reservoir (R1), and at least one tube for injecting a substance to be injected by at least one needle; 89. The method of claim 88.

90. a needle cooperating element (13; 113; 213; 713) arranged to cooperate with the at least one injection needle (11) during advancement or retraction of the at least one injection needle (11), and further comprising a cross guide (15; 115; 215; 715) to which the needle cooperating element (13; 113; 213; 713) is coupled so as to be movable to different positions in a displacement direction different from the advancement direction and the retraction direction, 88. A system according to any one of claims 1 to 87.

91. The device comprises two linear bearings (102) arranged in parallel, and a translation frame (103) that connects the two linear bearings (102) and is arranged to move along the two linear bearings (102) in the advancing and retracting directions of at least one infusion needle (11) so that movement of the translation frame (103) advances or retracts, or both advances and retracts, at least one infusion needle (11); 88. A system according to any one of claims 1 to 87.

92. the drive unit (100; 200; 700) comprises an advancement cable (130; 230; 730), pulling the advancement cable (130; 230; 730) causes advancement or retraction of at least one infusion needle (11), the advancement cable (130; 230; 730) forming part of a block and tackle set-up; 88. A system according to any one of claims 1 to 87.

93. The drive unit (200) comprises a combination of an advance / retract cable (230) and a displacement cable (230) arranged so that the drive unit (200) can both advance or retract at least one infusion needle (11) by pulling the advance / retract cable (230) and cause displacement of the at least one infusion needle (11) in a displacement direction different from the advancement direction and the retraction direction.

88. A system according to any one of claims 1 to 87.

94. At least one injection needle (11) has a tubular needle body with a distal end (11C), an injection port (11A) arranged at the distal end (11C) so as to be able to inject a substance through the at least one injection needle (11), and a supply port (11D) arranged at a position remote from the distal end (11C) so as to be able to receive a substance to be injected; a needle lumen inside the tubular needle body that connects the injection port (11A) and the supply port (11D); Equipped with The supply port (11D) is a side port located on the side of the tubular needle body.

88. A system according to any one of claims 1 to 87.

95. An injection port (11A) is provided on the side of at least one infusion needle (11); The injection port (11A) is spaced less than 2 mm from the tip end (11C) of the at least one infusion needle (11).

88. A system according to any one of claims 1 to 87.

96. An injection port (11A) is provided on the side of at least one injection needle (11); When the at least one injection needle (11) is in the retracted position, the tip (11C) of the at least one transfusion needle (11) is positioned within the tube; the inner surface of the tube and the outer surface of the at least one infusion needle (11) are sealed fluid-tight to each other to prevent fluid from entering the injection port (11A) through the tube; 88. A system according to any one of claims 1 to 87.

97. The penetrating portion (14) is at least partially made of an elastic material, a passage (14A) for passing at least one injection needle (11) therethrough is pre-configured therein, the passage (14A) being normally closed by an elastic force generated by the elasticity of the elastic material; 88. A system according to any one of claims 1 to 87.

98. An injection port (11A) is provided on the side of at least one injection needle (11), The injection port (11A) has a rounded or chamfered edge at the transition between the injection port (11A) and the side surface; 88. A system according to any one of claims 1 to 87.

99. An infusion needle (11) an injection needle (11) consisting of a tip (11C) and a hollow body, the tip (11C) having an injection port (11A) in front thereof through which a substance can be expelled to the outside of the injection needle (11); a stylet (99) movable within the hollow body between an advanced position in which the stylet (99) advances within the hollow body to close the injection port (11A) to prevent fibrosis from growing within the infusion needle (11) when the infusion needle (11) is placed in a patient, and a retracted position in which the stylet (99) retracts within the hollow body to open a path for substances to pass through the hollow body and out of the injection port (11A); Equipped with 88. A system according to any one of claims 1 to 87.

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