System for treating hypertensive patients

Abstract

The present invention relates to an at least partially implantable system for injecting a substance into a patient's body, the system comprising: a housing for implantation into a 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 the infusion of substances, particularly drugs, into a patient's body, particularly into the patient's blood circulatory system, or to stimulate penile erection, by means of an at least partially implantable drug delivery system. [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, the infusion needle is movably positioned within the housing so that it can be advanced with its tip 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 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] A general object of the present disclosure is to improve upon the implantable drug delivery systems described above.

[0005] 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, WO 2010 / 040548 A1 does not provide any specific disclosure as to how the drive unit should be configured to achieve this.

[0006] It is therefore a particular object of the present disclosure to provide an improved drive device for moving an infusion needle or needles, such as movement in an advancing / retracting direction, a lateral displacement direction, or both an advancing / retracting direction and a lateral displacement direction.

[0007] As mentioned above, WO2010 / 040548A1 also provides multiple injection needles according to the present disclosure. In WO2010 / 040548A1, valves are used to distribute the substance to be injected to each of the multiple injection needles. This requires valve actuation, thus increasing the operational complexity of the system.

[0008] Therefore, another object of the present disclosure is to facilitate a method for supplying the substance to be injected to each of the injection needles when the system is comprised of multiple injection needles.

[0009] As noted above, in WO2010 / 040548A1 and in accordance with the present disclosure, the infusion needle is advanced so that its tip penetrates a septum in the outer wall of the housing, which may result in material from the septum being introduced into the patient's body.

[0010] It is therefore a further object of the present disclosure to improve the system and / or infusion needle to prevent, or at least minimize the risk of, material from the septum in the outer wall of the housing through which the needle extends being introduced into the patient's body.

[0011] Thus, an at least partially implantable system for injecting a substance into a patient's body according to the present disclosure is 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 disposed within the housing or casing 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, wherein when the at least one 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 at least one 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; and - According to one variant, a drive unit arranged to advance and retract the injection needle or needles in opposite forward and retraction directions so that, on advancement, their distal end penetrates said penetration area so as to be able to inject a substance through the penetration area via the needle or needles.

[0012] 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.

[0013] 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.

[0014] 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. First embodiment - Cross guide (with needle cooperating member)

[0015] 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.

[0016] 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.

[0017] 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.

[0018] Preferably, the system comprises a translation frame arranged to move in the direction of advancement and retraction of the needle or needles, the cross guide being fixed to the translation frame for movement therewith. In this way, once the needle cooperating member has been brought into a desired position relative to the cross guide, it can be moved in the direction of advancement and retraction of the needle or needles 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] If the at least one infusion needle consists of 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 securely hold the infusion needle in place.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] At least one 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. Alternatively, 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.

[0029] 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.

[0030] 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.

[0031] In all embodiments where a cable is employed, the cable is preferably a Bowden cable so that it can transmit pulling forces while being flexible, which is particularly advantageous when part of the drive is remote from the housing and the cable extends into the housing from a remotely located motor.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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, 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 upon 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 of between 0.5 N and 2 N, preferably between 0.8 N and 1.2 N, and most preferably about 1 N.

[0036] 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 axis of rotation and the second wheel having a second axis of rotation parallel to and spaced apart from the first axis of rotation, and the displacement cable or belt can be wound around the first wheel and the second wheel.

[0037] Preferably, the displacement cable or belt is endless, for example in the form of a loop that extends from the first wheel to the second wheel, wraps around the second wheel 180°, or preferably—to prevent slippage of the cable or belt—180° plus a number of additional complete revolutions, returns from the second wheel to the first wheel, and wraps around the first wheel 180°, or—again preferably—180° plus a number of additional complete 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.

[0038] 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.

[0039] A motor can be located 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 arrange a drive cable to rotate the first or second wheel, which accordingly extends outside the housing and connects to a remote motor. In this case, the drive cable can be connected to one of the first and second wheels and wrapped around the first or second wheel, or wrapped around the first or second wheel.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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 a 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 located at a location outside the patient, remote from the housing, or more preferably somewhere inside the patient.

[0047] 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. Thus, the motor for driving the advancement cable can be relatively small.

[0048] When an advancement cable is arranged to move the translation frame along the linear bearing or bearings in forward and reverse directions, the block-and-tackle setup can comprise 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.

[0049] 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.

[0050] 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.

[0051] In this case, when the advance / retract cable is arranged to move the translation frame in an advance / retract direction along the linear bearing or bearings, 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 the other 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.

[0052] 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.

[0053] 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 one of the two second pulleys, i.e., in the displacement direction of the infusion needle or needles.

[0054] 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.

[0055] As is apparent from the foregoing, in this fourth aspect, two 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 a needle cooperating member in each of the opposite displacement directions.

[0056] 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.

[0057] 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 there is only a single infusion needle, so that only a single supply lumen is required, it may also be advantageously employed in a system consisting of 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] In all embodiments, the maximum size of the housing is preferably 30mm x 40mm x 6mm.

[0064] Communications Applications: Further aspects of the present disclosure may increase the security of the system against unauthorized third-party intervention. 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 includes inputting patient authentication data.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] For 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.

[0069] 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 input by the user matches data from the sensory generator related to the sensation generated by the sensory generator. Again, certain functions of the system 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.

[0070] 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.

[0071] 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.

[0072] According to one embodiment, the external device comprises a portable electronic device.

[0073] 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.

[0074] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device, an advantage of which is that communication with the display device can be achieved without the need for wires.

[0075] 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, the first and second communication frequencies being different. An advantage of this embodiment is that the possibility of interference is reduced.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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 between the first and second communication units can be independently selected depending on which antenna better suits the needs of the communication units.

[0081] 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.

[0082] 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 is that it allows communication with additional external devices, thereby providing redundancy and reliability.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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 between the first and second communication units can be independently selected depending on which antenna better suits the needs of the communication units.

[0088] 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.

[0089] 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.

[0090] According to one embodiment, the housing unit is configured to transmit information related to 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.

[0091] 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.

[0092] According to one embodiment, the display device comprises a touchscreen configured to display a user interface and receive input from the patient. An advantage of this embodiment is that it allows the patient to interact with information in a familiar manner.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] According to one embodiment, the standard network protocol is one from 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.

[0097] According to one embodiment, the second communication unit of the housing unit comprises a Bluetooth transceiver.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device.

[0116] 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.

[0117] According to one embodiment, the housing unit is configured to transmit information regarding the display of the user interface to the display device.

[0118] According to one embodiment, the housing unit is configured to receive patient input from a display device.

[0119] According to one embodiment, the housing unit is configured to display a user interface to the patient.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communications received from the display device.

[0124] According to one embodiment, the housing unit is further adapted to transmit encrypted communications to the implantable medical device using the second communications unit.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] According to one embodiment, at least a portion of the housing flexes to mechanically connect to the display device.

[0129] According to one embodiment, at least a portion of the housing is configured to sandwich a display device.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] According to one embodiment, the security module comprises a set of rules for accepting communications from a central device.

[0134] 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.

[0135] 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.

[0136] According to one embodiment, the central device is configured to verify the digital signature of the communication received from the external device.

[0137] 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.

[0138] According to one embodiment, the central device is configured to check the size of the communication received from the external device.

[0139] 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.

[0140] 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 first and second layers 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.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] According to one embodiment, the set of rules includes rules relating to data transfer rates between the central unit and the security modules.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] According to one embodiment, the implantable controller is configured to receive, using a wireless transceiver, a message from an external device that includes a first unencrypted portion and a second encrypted portion, decrypt the encrypted portion, and verify the authenticity of the unencrypted portion using the decrypted portion.

[0150] 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.

[0151] According to one embodiment, the unencrypted portion comprises at least a portion of at least one instruction to an implantable medical device.

[0152] 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.

[0153] The patient's physiological parameters may include at least one of body temperature, heart rate, and saturation value.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] In any of the foregoing embodiments, the implantable controller may include at least one cryptographic processor.

[0159] The wireless transceiver, in either embodiment, may be configured to receive communications from a portable external device.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] 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 the list consisting of 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.

[0164] The wireless transceiver, in some embodiments, is configured to wirelessly communicate with external devices using a proprietary network protocol.

[0165] According to one embodiment, the wireless transceiver comprises a UWB transceiver.

[0166] According to one embodiment, the security module and / or the central unit and / or the radio transceiver are configured within the controller.

[0167] 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.

[0168] 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.

[0169] According to one embodiment, the controller is configured to vary the variable impedance in response when the measured parameter exceeds a threshold value.

[0170] 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.

[0171] According to one embodiment, the measurement unit is configured to measure a parameter related to the change in energy received by the coil.

[0172] 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.

[0173] 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.

[0174] 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.

[0175] 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.

[0176] 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.

[0177] 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.

[0178] 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.

[0179] According to one embodiment, the variation in impedance is configured to reduce the effective power received by the receiving unit.

[0180] According to one embodiment, a variable impedance is placed in series with the coil.

[0181] According to one embodiment, the variable impedance is placed in parallel with the coil.

[0182] 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.

[0183] 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 bloodstream. Implanting 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 complications for the patient. 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.

[0184] Fibrin is an insoluble protein produced in part in response to bleeding and is the main component of blood clots. It 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 fibrinogen-to-fibrin formation begins with attracting 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. The 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.

[0185] 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.

[0186] 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.

[0187] 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 outer surface of each of the components. This 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.

[0188] A second coating may be provided on the first coating. The second coating may be a different biological material from the first coating. In particular, the first coating may consist of a perfluorocarbon layer chemically attached to the surface, and the second coating may consist of a liquid perfluorocarbon layer.

[0189] 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.

[0190] 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.

[0191] 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. First issue: The needle port distance is short.

[0192] 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.

[0193] 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.

[0194] 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; -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.

[0195] 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°.

[0196] 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.

[0197] 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.

[0198] 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.

[0199] 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 within a patient's body, the housing having an outer wall with a penetration; at least one infusion needle arranged within 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 patient's body 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 patient's body 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.

[0200] 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 around 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 involve rotation of the distal end portion of the infusion needle around a rotation axis that is perpendicular to the curved surface. It is further preferable to combine a curved needle with a curved surface on which a blood vessel is placed.

[0201] 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.

[0202] 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 herein consists of a rotation of a tip portion of the at least one infusion needle around an axis of rotation that is perpendicular to the plane of curvature.

[0203] 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.

[0204] 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 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.

[0205] 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;

[0206] Second Challenge - Pre-set Elastic Openings 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.

[0207] 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.

[0208] 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.

[0209] 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.

[0210] 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; 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.

[0211] 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.

[0212] 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 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 movement of the injection needle.

[0213] Fourth Aspect—Needle with Stylet According to the 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 this 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, in order to prevent fibrosis from growing within the infusion needle when the infusion needle is placed in a patient, and a 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 out the injection port.

[0214] 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.

[0215] 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.

[0216] 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.

[0217] 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.

[0218] 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.

[0219] 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 comprises 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 way, 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.

[0220] 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 to pass through the penetration; the drive unit may 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 and a hollow body, preferably having a supply port on the 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 the front face of the tip so that the substance can be expelled out of the 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.

[0221] 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.

[0222] An embodiment comprising 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 a 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, further comprising a stylet.

[0223] 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.

[0224] 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 arms in a retraction direction about the common rotation axis to retract the stylet within the infusion needle to a retracted position; - Rotating the needle arms in the retraction direction around the 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.

[0225] 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.

[0226] 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.

[0227] 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 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 tip of at least one infusion needle, which is a portion including the tip of at least one infusion needle, is curved within a curvature plane, and the tip is inclined at an inclination angle in the range 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 through which a substance can be supplied into the hollow body, and with an injection port in the front of the tip so that the substance can be dispensed out of an 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 substance - preferably from the delivery port - through the hollow body and out the injection port); wherein 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.

[0228] 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.

[0229] 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.

[0230] 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.

[0231] One end of the torque spring can be attached to the stylet arm and the other end of the torque spring can be attached 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 can be attached 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 stylet is moved from the infusion needle.

[0232] 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.

[0233] In this embodiment, where the driver comprises 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 where the infusion needle is not completely retracted into the housing, i.e., where at least the tip of the infusion needle is not retracted into the housing. In at least those embodiments where the tip of the infusion needle is also 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.

[0234] 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.

[0235] 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 in the same direction by the biasing element, 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 unit engages the stylet arm (or needle arm) or both the stylet arm and the needle arm, resulting in one or both of the two arms moving in opposite directions against the biasing force.

[0236] 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.

[0237] 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.

[0238] 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.

[0239] In this embodiment, in which the drive unit is composed of 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.

[0240] 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.

[0241] 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.

[0242] 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.

[0243] 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.

[0244] 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.

[0245] 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.

[0246] 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.

[0247] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the second end.

[0248] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the second end.

[0249] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the second end.

[0250] In some embodiments, the distal region of the second portion is conical.

[0251] In some embodiments, the second portion has rotational symmetry along the first direction.

[0252] In some embodiments, the second surface of the second portion is substantially perpendicular to the central extension of the connecting portion.

[0253] In some embodiments, the second surface of the second portion is substantially parallel to the second plane.

[0254] 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.

[0255] 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.

[0256] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the first end.

[0257] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the first end.

[0258] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the first end.

[0259] In some embodiments, the proximal region of the second portion is conical.

[0260] In some embodiments, the first end and the second end each comprise an elliptical point.

[0261] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0262] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0263] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0264] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0265] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0266] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0267] 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.

[0268] 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.

[0269] In some embodiments, the second direction is parallel to a second plane.

[0270] 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.

[0271] In some embodiments, the second portion tapers from the first end to the second end.

[0272] In some embodiments, the second portion tapers from an intermediate region of the second portion to each of the first and second ends.

[0273] 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.

[0274] 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.

[0275] 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.

[0276] 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.

[0277] 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.

[0278] 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.

[0279] In some embodiments, the distal region is configured to face downward in a standing patient.

[0280] 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.

[0281] 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.

[0282] 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.

[0283] 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.

[0284] 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.

[0285] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0286] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0287] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0288] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0289] In some embodiments, the second portion comprises a second wireless energy receiver.

[0290] In some embodiments, the first portion comprises a first energy storage unit.

[0291] In some embodiments, the second portion comprises a second energy storage unit.

[0292] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0293] In some embodiments, the solid state battery is a thionyl chloride battery.

[0294] 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.

[0295] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0296] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0297] 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.

[0298] 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.

[0299] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0300] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0301] 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.

[0302] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0303] 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.

[0304] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0305] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0306] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0307] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0308] In some embodiments, the second portion comprises at least one electric motor.

[0309] 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.

[0310] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0311] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0312] In some embodiments, the transmission comprises a gear system.

[0313] 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.

[0314] In some embodiments, the second part comprises at least one hydraulic pump.

[0315] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0316] 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.

[0317] 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.

[0318] 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.

[0319] 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.

[0320] 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.

[0321] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0322] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0323] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0324] 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 the patient.

[0325] In some embodiments, the walls of the first chamber are resilient to allow expansion of the first chamber.

[0326] In some embodiments, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuable implant element configured to exert a force on the patient's body part and a second hydraulic system in fluid communication with a second hydraulically actuable implant element configured to exert a force on the patient's body part, wherein the first and second hydraulically actuable implant elements are adjustable independently of one another.

[0327] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0328] In some embodiments, each of the first and second hydraulic systems includes a reservoir for holding hydraulic fluid.

[0329] 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.

[0330] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0331] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0332] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0333] 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.

[0334] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0335] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency above the frequency level to an external device.

[0336] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0337] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0338] 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.

[0339] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0340] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0341] 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.

[0342] 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.

[0343] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0344] 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.

[0345] In some embodiments, the second portion comprises an outer casing made of titanium.

[0346] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0347] 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 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 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 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, such 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 is configured to receive and / or transmit electromagnetic waves at a frequency less than a frequency level, the frequency level being 100 kHz.

[0348] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0349] 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.

[0350] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to an external device.

[0351] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0352] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0353] 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.

[0354] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0355] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0356] 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.

[0357] 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.

[0358] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0359] In some embodiments, the first portion comprises an outer casing made of titanium.

[0360] 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.

[0361] In some embodiments, the second portion comprises an outer casing made of titanium.

[0362] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0363] 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 being configured to face a third plane. and a connecting portion having a third cross-sectional area in the first plane and including a third surface configured to engage a first tissue surface of a first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter 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 to prevent the first portion, second portion, and connecting portion from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes, the first portion being made from a polymeric material and the second portion consisting of a casing made from titanium, the casing forming a complete housing.

[0364] 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.

[0365] In some embodiments, the first portion comprises a casing made from a polymeric material.

[0366] 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.

[0367] 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.

[0368] In some embodiments, the joint is disposed in the joint core such that it is sealed by the outer material of the joint.

[0369] In some embodiments, the coupling portion comprises a ceramic material.

[0370] In some embodiments, the connections are encapsulated in a ceramic material.

[0371] In some embodiments, the first portion comprises a first connecting portion configured to connect to a connecting portion of the connecting portion.

[0372] In some embodiments, the second portion comprises a second connecting portion configured to connect to the connecting portion of the connecting portion.

[0373] In some embodiments, the casing of the second part is hermetically sealed.

[0374] In some embodiments, the second connection is positioned such that the hermetic seal of the second portion remains intact.

[0375] In some embodiments, the casing of the first part is sealed.

[0376] 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 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 third surface configured to engage a first tissue surface on the first side of the tissue portion, the first portion is configured to connect to a 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, preventing the first portion, the second portion, and the connecting portion from moving through a hole 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 lengthwise 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 lengthwise direction, or the second portion has a cross-sectional area that decreases in a lengthwise direction.

[0377] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0378] In some embodiments, the connecting portion tapers along the central extension axis in a direction from the first portion to the second portion.

[0379] 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.

[0380] In some embodiments, the second portion is tapered in its length.

[0381] In some embodiments, the connecting portion has a circular or elliptical cross section that decreases in diameter along its length.

[0382] 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.

[0383] In some embodiments, the length direction extends substantially perpendicular to the central elongation axis.

[0384] 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 with a first cross-sectional area in a third plane; a connecting portion configured to be positioned 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, 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 fluids 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.

[0385] In some embodiments, the flexible structure is configured to allow the linking portion to flex in multiple directions.

[0386] In some embodiments, the flexible structure is configured to allow the linking portion to flex in any direction.

[0387] In some embodiments, the flexible structure comprises a bellows.

[0388] In some embodiments, the bellows is a metal bellows.

[0389] In some embodiments, the metal bellows is welded.

[0390] In some embodiments, the bellows is a titanium bellows.

[0391] In some embodiments, the bellows forms part of a hermetic seal arrangement.

[0392] In some embodiments, the flexible structure comprises an elevating portion that allows said deflection of the connecting portion.

[0393] In some embodiments, the lifting portion is configured to allow the linking portion to be compressed and / or expanded.

[0394] In some embodiments, the flexible structure has a substantially cylindrical shape.

[0395] In some embodiments, the flexible structure is configured to seal against the first portion and / or the second portion.

[0396] In some embodiments, the connecting portion and the second portion are hermetically sealed from the first portion.

[0397] 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.

[0398] 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.

[0399] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0400] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0401] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0402] In some embodiments, the solid state battery is a thionyl chloride battery.

[0403] 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.

[0404] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0405] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0406] 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.

[0407] 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;

[0408] 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.

[0409] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0410] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0411] 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.

[0412] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0413] 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.

[0414] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0415] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0416] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0417] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0418] 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.

[0419] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0420] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0421] 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.

[0422] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0423] In some embodiments, the first end and the second end each comprise an elliptical point.

[0424] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0425] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0426] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0427] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0428] 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.

[0429] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0430] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0431] In some embodiments, the gear arrangement comprises a gear system.

[0432] 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.

[0433] In some embodiments, the second part comprises at least one hydraulic pump.

[0434] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0435] 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; 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, the first end being proximal to the first portion and the second end being distal to the first portion, and 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.

[0436] In some embodiments, the physical footprint comprises a cross-sectional area perpendicular to a central axis.

[0437] 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.

[0438] In some embodiments, the unit comprises a corner that forms a bend in the unit.

[0439] 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°.

[0440] 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.

[0441] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0442] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0443] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0444] In some embodiments, the solid state battery is a thionyl chloride battery.

[0445] 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.

[0446] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0447] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0448] 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.

[0449] 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.

[0450] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0451] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0452] 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.

[0453] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0454] 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.

[0455] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0456] 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.

[0457] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0458] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0459] 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.

[0460] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0461] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0462] 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.

[0463] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0464] In some embodiments, the first end and the second end each comprise an elliptical point.

[0465] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0466] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0467] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0468] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0469] 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.

[0470] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0471] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0472] In some embodiments, the gear arrangement comprises a gear system.

[0473] 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.

[0474] In some embodiments, the second part comprises at least one hydraulic pump.

[0475] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0476] 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 having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, 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, 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 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.

[0477] 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 second tissue surface on the second side of the tissue portion. a second surface configured to engage the first portion; a connecting portion configured to be positioned 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, the connecting portion configured to connect the first portion to the second portion; and an electric motor, 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 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, and at least a portion of the electric motor is disposed within the connecting portion.

[0478] 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.

[0479] 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.

[0480] 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.

[0481] 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.

[0482] 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.

[0483] 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.

[0484] In some embodiments, the electric motor extends through the coupling portion to the first portion and / or the second portion.

[0485] 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.

[0486] 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.

[0487] In some embodiments, the electric motor extends through 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.

[0488] 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.

[0489] 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.

[0490] 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.

[0491] 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.

[0492] In some embodiments, the gear arrangement extends through the linking portion to the first portion and / or the second portion.

[0493] 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.

[0494] 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.

[0495] 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.

[0496] 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.

[0497] In some embodiments, the gear arrangement is or consists of a worm drive.

[0498] 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.

[0499] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0500] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0501] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0502] In some embodiments, the solid state battery is a thionyl chloride battery.

[0503] 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.

[0504] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0505] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0506] 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.

[0507] 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.

[0508] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0509] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0510] 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.

[0511] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0512] 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.

[0513] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0514] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0515] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0516] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0517] 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.

[0518] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0519] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0520] 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.

[0521] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0522] In some embodiments, the first end and the second end each comprise an elliptical point.

[0523] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0524] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0525] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0526] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0527] 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.

[0528] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0529] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0530] In some embodiments, the gear arrangement comprises a gear system.

[0531] 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.

[0532] In some embodiments, the second part comprises at least one hydraulic pump.

[0533] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0534] 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.

[0535] 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.

[0536] In some embodiments, the implantable energized medical device further comprises a connecting portion.

[0537] In some embodiments, the connecting portion is integrally formed with the first portion.

[0538] 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.

[0539] 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.

[0540] In some embodiments, the first portion is configured to removably connect, directly or indirectly, to the second portion.

[0541] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter.

[0542] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0543] In some embodiments, the first energy storage unit is a solid-state battery.

[0544] In some embodiments, the solid state battery is a thionyl chloride battery.

[0545] 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.

[0546] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0547] In some embodiments, the first controller is connected to a wireless transceiver for wireless communication with an external device.

[0548] 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.

[0549] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0550] 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.

[0551] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0552] 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.

[0553] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0554] 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 tissue surface. a second portion facing the first side of the tissue portion, 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 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 the surfaces 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; 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 configured to transfer fluid between the implantable 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 reservoir, the implantable pump, and the implantable electric motor are disposed external to the implantable energized medical device.

[0555] 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 and second portions. a body-engaging implant comprising: an implantable energy storage unit 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 first portion and the second portion are configured to be prevented from moving through a hole 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 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 disposed external to the implantable energized medical device.

[0556] 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 and second portions. an implantable energy storage unit comprising: a connecting portion formed with the first portion; and 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 one another and the third cross-sectional area is smaller than the first and second cross-sectional areas to prevent the first portion and the second portion from moving through a hole in the tissue portion in a direction perpendicular to the first, second, and third planes; an implantable reservoir configured to hold a fluid; and an implantable pump configured to transfer fluid between the implantable reservoir and the body-engaging implant via a conduit, respectively; 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 disposed external to the implantable energized medical device.

[0557] 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 being configured to connect the first portion to the second portion. , connecting portion, or second portion, wherein: a body-engaging implant having first, second, and third planes parallel to one another, a third cross-sectional area smaller than the first and second cross-sectional areas, and configured to prevent movement of the first and second portions through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes, wherein the body-engaging implant is 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 configured to transfer fluid between the 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.

[0558] 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 pump disposed on the first portion, the connecting portion, or the second portion, 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 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 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; the implantable pump is configured to transfer fluid between the implantable reservoir and each of the body-engaging implants via conduits, and the implantable energy storage unit, the implantable reservoir, and the implantable electric motor are located external to the implantable energized medical device.

[0559] 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 configured to connect the first portion to the second portion, 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, the 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.

[0560] 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. 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 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 energy storage unit disposed on 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, the implantable electric motor coupled to an implantable energy storage unit; a body-engaging implant, 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 portion and the second portion from moving in a direction perpendicular to the first, second, and third planes through an opening in the tissue portion; 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 exert a force on a body tissue or a body organ; and an implantable pump 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 disposed external to the implantable energized medical device.

[0561] 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; and a fluid retaining member disposed in the first portion, the connecting portion, or the second portion. an implantable reservoir configured to move fluid through a hole in the tissue portion in a direction perpendicular to the first, second, and third planes; 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 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 at least one of stretch, contract, expand, stimulate, and bias the body tissue or body organ; and an implantable pump configured to transfer fluid between the implantable reservoir and the body-engaging implant via a conduit, respectively, 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 and the implantable pump are disposed external to the implantable energized medical device.

[0562] 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 part configured to be positioned on a first side of the tissue portion, the first part 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 part configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second part having a second cross-sectional area in a second plane and comprising a first surface configured to face a second tissue surface 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, the implantable reservoir being disposed in the first portion, the connecting portion, or the second portion; and an implantable pump disposed in the first portion, the connecting portion, or the second portion, wherein an implantable pump, the implantable pump being 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;

[0563] 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. a 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 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 pump disposed on the first portion, the connecting portion, or the second portion; and an implantable energy storage unit disposed in the first or 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 body-engaging implant is configured to prevent movement of the first and second portions 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 perform at least one of stretching, contracting, expanding, stimulating, and energizing on the body tissue or body organ; an implantable pump 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, and the implantable reservoir and implantable electric motor are disposed external to the implantable energized medical device.

[0564] 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 a connecting portion configured to connect to the portion; and 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 portion and the second portion 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 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.

[0565] 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 tissue surface. a second portion facing a first side, 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 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 in the first portion, the connecting portion, or the second portion; an implantable energy storage unit 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, the implantable electric motor coupled to the implantable energy storage unit; an implantable reservoir configured to hold a fluid, the implantable reservoir 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, so as 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 a body organ; an implantable pump configured to transport a fluid through a conduit to the implantable reservoir and the body-engaging implant, respectively;An implantable pump, wherein an implantable electric motor is configured to operate the implantable pump, the implantable pump being disposed external to the implantable energized medical device;

[0566] 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 second cross-sectional area in a second plane and comprising a second surface configured to face a first tissue surface of the second side of the tissue portion. a second portion having a second surface configured to engage a tissue surface of the tissue portion; a connecting portion configured to be disposed through an aperture 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 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; and an implantable pump disposed in the first portion, the connecting portion, or the second portion, a body-engaging implant configured such that 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 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; and a body-engaging implant and an implantable energy storage unit configured to perform at least one of stretching, contracting, expanding, stimulating, and biasing on a body tissue or a body organ, the implantable energy storage unit including an implantable pump configured to transport fluid through a conduit to the implantable reservoir and the body-engaging implant, respectively; an 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;

[0567] 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. 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 comprising: the first portion, the connecting 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; 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; and an implantable energy storage unit 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 configured to prevent the first portion and the second portion from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; 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 biasing on the body tissue or body organ, 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 electric motor is disposed external to the implantable energized medical device;

[0568] 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. a 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 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 pump disposed on the first portion, the connecting portion, or the second portion; and an implantable energy storage unit disposed in the first part, the connecting part or the second part; and an electric motor disposed in the first part, the connecting part or the second part, 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 body-engaging implant is configured to prevent the first part and the second part from moving through a hole in the tissue part in a direction perpendicular to the first, second and third planes; an implantable reservoir configured to hold a fluid and the body-engaging implant configured to perform at least one of stretching, contracting, expanding, stimulating and energizing on the body tissue or body organ; an implantable electric motor connected to the implantable energy storage unit, the implantable electric motor configured to operate an implantable pump; the implantable pump configured to transfer fluid to and from the implantable reservoir and the body-engaging implant, respectively, via a conduit, and the implantable reservoir is disposed external to the implantable energized medical device.

[0569] 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; 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. 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 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 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 actuate the body-engaging implant; wherein the implantable electric motor is disposed external to the implantable energized medical device.

[0570] 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.

[0571] 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.

[0572] 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.

[0573] 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.

[0574] 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.

[0575] 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.

[0576] In some embodiments, the implantable electric motor is operably connected to the implantable pump via a rotatable shaft.

[0577] In some embodiments, the implantable electric motor is operatively connected to the implantable pump via a magnetic coupling.

[0578] 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.

[0579] 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.

[0580] 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.

[0581] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0582] 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.

[0583] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0584] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0585] 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.

[0586] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0587] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0588] 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.

[0589] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0590] In some embodiments, the first end and the second end each comprise an elliptical point.

[0591] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0592] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0593] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0594] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0595] 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.

[0596] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0597] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0598] In some embodiments, the gear arrangement comprises a gear system.

[0599] 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.

[0600] In some embodiments, the pump is a hydraulic pump.

[0601] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0602] 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 having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, 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 a hole in the tissue portion in a direction perpendicular to the first, second and third planes, and the first portion is configured to be placed subcutaneously in the patient, and the first portion includes a connection interface arrangement for transmitting wired energy and / or wired communication signals and / or fluid to an additional implant in the patient.

[0603] 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.

[0604] In some embodiments the connection interface arrangement comprises a port for transferring fluid from the first portion to said additional implant.

[0605] 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.

[0606] 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.

[0607] In some embodiments, the height of the first portion is the maximum height.

[0608] 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.

[0609] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0610] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0611] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0612] In some embodiments, the solid state battery is a thionyl chloride battery.

[0613] 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.

[0614] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0615] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0616] 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.

[0617] 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.

[0618] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0619] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0620] 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.

[0621] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0622] 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.

[0623] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0624] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0625] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0626] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0627] 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.

[0628] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0629] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0630] 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.

[0631] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0632] In some embodiments, the first end and the second end each comprise an elliptical point.

[0633] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0634] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0635] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0636] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0637] 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.

[0638] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0639] In some embodiments, the gear arrangement is configured to convert rotational force into linear force.

[0640] In some embodiments, the gear arrangement comprises a gear system.

[0641] 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.

[0642] In some embodiments, the second part comprises at least one hydraulic pump.

[0643] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0644] 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.

[0645] 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.

[0646] 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%.

[0647] 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%.

[0648] 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.

[0649] 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.

[0650] 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.

[0651] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0652] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0653] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0654] In some embodiments, the solid state battery is a thionyl chloride battery.

[0655] 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.

[0656] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0657] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0658] 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.

[0659] 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.

[0660] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0661] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0662] 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.

[0663] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0664] 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.

[0665] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0666] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0667] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0668] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0669] 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.

[0670] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0671] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0672] 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.

[0673] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0674] In some embodiments, the first end and the second end each comprise an elliptical point.

[0675] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0676] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0677] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0678] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0679] 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.

[0680] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0681] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0682] In some embodiments, the gear arrangement comprises a gear system.

[0683] 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.

[0684] In some embodiments, the second part comprises at least one hydraulic pump.

[0685] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0686] 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 including 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 second portion, 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 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 second portion comprises or forms a reservoir for holding a fluid; The implantable medical device further includes a sealed container 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 into 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 portion and the second portion are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0687] In some embodiments, the actuator comprises an electric motor.

[0688] In some embodiments, the actuator is located at the linkage.

[0689] In some embodiments, the actuator is located partially or completely within the enclosed enclosure.

[0690] 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.

[0691] 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.

[0692] 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.

[0693] In some embodiments, the implantable energized medical device further comprises an internal conduit connecting the injection port to the reservoir.

[0694] In some embodiments, the enclosure is a bellows.

[0695] In some embodiments, the bellows is a metal bellows.

[0696] In some embodiments, at least a portion of the enclosed container configured to come into contact with the fluid is made of metal.

[0697] 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.

[0698] 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.

[0699] 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.

[0700] 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.

[0701] 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.

[0702] In some embodiments, the first energy storage unit is connected to the first wireless energy receiver.

[0703] In some embodiments, the second portion comprises a second energy storage unit, the second energy storage unit being connected to a second wireless energy receiver.

[0704] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0705] In some embodiments, the solid state battery is a thionyl chloride battery.

[0706] 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.

[0707] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0708] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0709] In some embodiments, the first controller and / or the second controller are configured to control the actuator.

[0710] 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.

[0711] 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.

[0712] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0713] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0714] 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.

[0715] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0716] 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.

[0717] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0718] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0719] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0720] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0721] 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.

[0722] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0723] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0724] 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.

[0725] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0726] In some embodiments, the first end and the second end each comprise an elliptical point.

[0727] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0728] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0729] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0730] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0731] 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.

[0732] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0733] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0734] In some embodiments, the gear arrangement comprises a gear system.

[0735] 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]

[0736] 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 consists of 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 consists of a housing and a display device that communicates wirelessly 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 porting the system. [Figure 27] FIG. 27 shows one embodiment of an implantable energized medical device. [Figure 28] FIG. 28 shows 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] Figure 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 components 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 an implantable medical device or body-engaged part. [Figure 57A]FIG. 57A is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57B] FIG. 57B is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57C] FIG. 57C is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57D] FIG. 57D is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57E] FIG. 57E is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57F] FIG. 57F is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57G] FIG. 57G is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57H] FIG. 57H is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57I] FIG. 57I is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57J] FIG. 57J is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57K] FIG. 57K is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57L] FIG. 57L is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57M] FIG. 57M is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57N] FIG. 57N is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57P] FIG. 57P is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 57Q]FIG. 57Q is a schematic cross-sectional plan view of a system comprising an implantable energized medical device. [Figure 58A] FIG. 58A is a cross-sectional plan view of an embodiment of an implantable energized medical device. [Figure 58B] FIG. 58B is a cross-sectional plan view of an embodiment of an implantable energized medical device. [Figure 59A] FIG. 59A is a cross-sectional plan view of an embodiment of an implantable energized medical device. [Figure 59B] FIG. 59B is a cross-sectional plan view of an embodiment of an implantable energized medical device. [Figure 60A] FIG. 60A shows a schematic representation of a variation of the overall system according to the first general aspect of FIG. 3, consisting of an angled injection needle. [Figure 60B] FIG. 60B shows a variation of FIG. 60A with a curved surface on the housing. [Figure 60C] FIG. 60C shows a variation of FIG. 60A with multiple infusion needles. [Figure 60D] FIG. 60D shows a variation of FIG. 60A with a curved needle. [Figure 60E] FIG. 60E shows a variation of FIG. 60A having a curved surface on the housing and a curved needle. [Figure 61] Figure 61 shows the principle of injecting a substance using a beveled injection needle. [Figure 62A] FIG. 62A shows a top view and a cross-sectional side view, respectively, of the front of the infusion needle, with the injection port located near the tip of the infusion needle. [Figure 62B] FIG. 62B shows a top view and a cross-sectional side view, respectively, of the front of the infusion needle, with the injection port located near the tip of the infusion needle. [Figure 63] FIG. 63 shows a schematic of the penetrations of the system with infusion needles placed in the respective tubes. [Figure 64] FIG. 64 shows a schematic representation of a penetration of the system having a pre-configured passageway with a widened entrance for entry of the infusion needle. [Figure 65]FIG. 65 shows a schematic representation of the penetrations of the system having preconfigured passages through which the infusion needles extend at their respective tips. [Figure 66] Figure 66 shows a schematic representation of a penetration of the system with width-extended passages and a pre-configured compressor for opening these passages. [Figure 67] FIG. 67 illustrates the principle of injecting a substance using an infusion needle consisting of a retractable stylet (the infusion needle is shown as angled, but need not be angled according to this principle). [Figure 68] FIG. 68 shows the principle of FIG. 67, with the stylet extending from the infusion needle. [Figure 69] FIG. 69 illustrates the principle shown in FIG. 67, with a styletted infusion needle extending from a laterally displaceable penetration. [Figure 70] FIG. 70 shows a variation of FIG. 60E with a curved infusion needle and stylet. [Figure 71A] FIG. 71A shows the first principle of the mechanism for rotating the needle arm and stylet arm, which involves a biasing element and a releasable holder. [Figure 71B] FIG. 71B shows the first principle of the mechanism for rotating the needle arm and stylet arm, which involves a biasing element and a releasable holder. [Figure 71C] FIG. 71C shows the first principle of the mechanism for rotating the needle arm and stylet arm, which involves a biasing element and a releasable holder. [Figure 71D] FIG. 71D shows the first principle of the mechanism for rotating the needle arm and stylet arm, which involves a biasing element and a releasable holder. [Figure 72] FIG. 72 shows the arrangement of FIGS. 71A to 71D implemented in an overall system according to a first embodiment of first principles. [Figure 73A] FIG. 73A shows the arrangement of FIGS. 71A to 71D implemented in an overall system according to a second embodiment of first principles. [Figure 73B] FIG. 73B shows the arrangement of FIGS. 71A to 71D implemented in an overall system according to a second embodiment of first principles. [Figure 74A] FIG. 74A shows a second principle of the mechanism for rotating the needle arm and stylet arm, which involves at least one biasing element and a clutch. [Figure 74B] FIG. 74B shows a second principle of the mechanism for rotating the needle arm and stylet arm, which involves at least one biasing element and a clutch. [Figure 74C] FIG. 74C shows a second principle of the mechanism for rotating the needle arm and stylet arm, which involves at least one biasing element and a clutch. [Fig. 74D] FIG. 74D shows a second principle of the mechanism for rotating the needle arm and stylet arm, which involves at least one biasing element and a clutch. [Figure 75A] FIG. 75A shows a clutch of a mechanism according to the second principle. [Figure 75B] FIG. 75B shows a clutch of the mechanism according to the second principle. [Figure 75C] FIG. 75C shows a clutch of the mechanism according to the second principle. [Figure 76] FIG. 76 shows the mechanisms of FIGS. 74A to 74D implemented in an overall system according to second principles. [Figure 77] FIG. 77 shows a third principle of the mechanism for rotating the needle arm and stylet arm, which now involves a needle crank arm and a stylet crank arm. [Figure 78] FIG. 78 shows a third principle mechanism which also includes a cam drive. [Figure 79A] FIG. 79A shows the different stages of the third principle mechanism including the needle crank arm, stylet crank arm, and cam drive. [Figure 79B] FIG. 79B shows the different stages of the third principle mechanism including the needle crank arm, stylet crank arm, and cam drive. [Figure 79C] FIG. 79C shows the different stages of the third principle mechanism including the needle crank arm, stylet crank arm, and cam drive. [Figure 80] FIG. 80 shows the mechanism of FIGS. 79A-79C implemented in an overall system according to the third principle. DETAILED DESCRIPTION OF THE INVENTION

[0737] Detailed explanation Hereinafter, a detailed description of embodiments of the present invention will be provided with reference to the accompanying drawings. It will be understood that the drawings are for illustrative purposes only and do not limit the scope of the present invention in any way. Accordingly, references to directions such as "up" and "down" refer only to the directions shown in the drawings. It should be noted that features having the same reference numerals have the same functions, and therefore, features of one embodiment can be interchanged with features of other embodiments having the same reference numerals unless there is a clear contradiction. Therefore, descriptions of features having the same reference numerals should be considered as complementary in explaining the basic idea of ​​the features, thereby demonstrating the versatility of the features.

[0738] The entire system The overall system of the present disclosure will now be described in detail with reference to FIG. 1, which illustrates a first variant of the overall system. The overall structure corresponds to that disclosed in FIG. 1 of WO 2010 / 040548 A1. This variant specifically shows a housing 12 equipped with a single infusion needle 11 and a drive unit D. The drive unit D is shown with arrows to indicate that the needle or needles 11 can be moved in different directions. The housing 12 includes a self-sealing penetration 14 positioned adjacent to a patient's blood vessel 7, which here takes the form of a corpus cavernosum, but may also be other types of blood vessels, particularly veins or arteries. The infusion needle has a tubular body with a closed tip and may include a laterally positioned delivery outlet port for delivering a drug. Therefore, the needle does not cut any material but simply splits it during penetration. Therefore, when the needle penetrates material, such as fibrosis and / or the self-sealing penetration 14 positioned in the housing wall, the material does not enter and block the drug delivery passageway.

[0739] A motor M in the housing 12 is housed within the housing 12 for driving part of the drive unit D. The motor M in the housing 12 is controlled by a control unit C2 that forms the implantable part of the control system, which further comprises an external data processing device C1 that can send commands and any other kind of data to the control unit C2. For example, the external data processing device C1 can be used to initiate an injection cycle from outside the patient's body, which is done wirelessly as indicated by arrow 23. The implanted control unit C2 not only controls the motor M in the housing 12, but also controls the supply of energy from the accumulator A to the motor M in the housing 12.

[0740] The external data processing device C1 may also be used to program the implanted control unit C2, and the data transfer port for transferring data between the external data processing device C1 and the implanted control unit C2 may be adapted to transfer data bidirectionally.

[0741] A feedback sensor F, implanted within the patient's penis, is shown here connected to the motor M within the housing 12 and may also be connected to the implantable control unit C2. The feedback sensor F may sense one or more physical parameters of the patient, such as intracorporal drug levels, flow rate through the corpora cavernosa, or intracorporal pressure. Other feedback sensors may be provided at different locations to sense process parameters of the system, such as electrical parameters, distension, distance, etc.

[0742] A conduit 19 connecting the needle 11 to the reservoir consisting of compartments R1 and R2, and wiring 24 for transmitting electrical energy from the energy source A to the motor M in the housing 12 are led through a common conduit 25.

[0743] In this variant of the overall system, the reservoir comprises a first compartment R1, e.g., containing saline solution, and a second compartment R2, e.g., containing a powdered or lyophilized drug. A pump P, driven by a second motor M2, is arranged to pump the infusion solution from the reservoir R1 to the infusion needle 11. The pumped solution passes through a mixing chamber 26, into which the drug is released from the reservoir R2 in a timed manner. The motor M2 or another motor may also drive the release of the drug from the second reservoir R2. The motor M2 is also controlled by the control unit C2. The infusion solution pumped by the pump P from the relatively large first reservoir R1 through the mixing chamber 26 mixes with the drug released from the second reservoir R2 and reaches the infusion needle 11, which has penetrated the self-sealing opening 14 of the housing 12, and flows into the corpus cavernosum 7.

[0744] In addition to or instead of the control unit C2, a pressure sensitive switch may be placed subcutaneously within the housing 12 for actuating the motor M and / or the motor M2.

[0745] The entire system can be configured with one of many different reservoir types, but a specific reservoir type will be described here. The volume of reservoir R1 is divided into two sections by membrane 31: one filled with gas and the other with infusion solution (saline). An injection port 32 allows reservoir R1 to be refilled with infusion solution using a refill needle. When reservoir R1 is full, the gas section is at normal or overpressurized pressure. As pump P draws infusion solution from reservoir R1 during each infusion cycle, the pressure in the gas section drops below ambient pressure, i.e., to a negative relative value. Depending on the particular type of pump P, it may be advantageous to provide a single-acting ball valve to prevent backflow from pump P into reservoir R1.

[0746] There are various ways of supplying energy to motors M and M2. In the illustrated variation, energy is supplied from outside the patient's body for direct use by the motors and / or for charging accumulator A, which may be in the form of a rechargeable battery and / or capacitor. An external primary energy source E transmits a first form of energy through the patient's skin 10 to an energy conversion device T, which converts the first form of energy into a second form of energy, such as electrical energy. The electrical energy is used to recharge accumulator A, which supplies secondary energy to motor M on demand.

[0747] The external primary energy source E can be adapted to generate an external field, such as an electromagnetic field, a magnetic field, an electric field, or to generate a wave signal, such as an electromagnetic wave or a sound wave signal. For example, the energy conversion device T functions as a solar cell, but can be adapted to generate a wave signal of a particular type for the primary energy source E.

[0748] Instead of an external primary energy source E, an implantable primary energy source E may be used in place of the accumulator A, such as a conventional long-life battery.

[0749] The energy signal may also be used to transmit signals from the external data processing device C1 by appropriate modulation of the energy signal, whether the energy is transmitted wirelessly or by wire, so that the energy signal serves as a carrier signal for digital or analog control signals. More particularly, the control signals may be frequency-modulated, phase-modulated, and / or amplitude-modulated signals.

[0750] Figure 2 shows a second variant of the overall system, which essentially differs from the system of Figure 1 only in that the motor M in the housing 12 is completely omitted. This is achieved by a cable 33 which replaces the wiring 24 of the system shown in Figure 1.

[0751] general concept 3 and 4 show two different general concepts of how the infusion needle 11 can penetrate the penetration area 14 at different penetration sites. According to the first concept shown in FIG. 3, the infusion needle 11 is accommodated in a housing 12 and attached to a needle cooperating member 13, which is reciprocable in a first direction (X direction) by a first actuator 16 and in a second direction (Y direction) by a second actuator 17. The first direction corresponds to the displacement direction of the infusion needle 11, i.e., the direction in which the infusion needle 11 is displaced laterally relative to the penetration site from one penetration site to the next. For this purpose, the needle cooperating member 13 is attached along a...

Claims

1. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) or casing adapted for implantation within a patient's body, said housing (12) or casing having an outer wall with a penetration region (14); at least one injection needle (11) arranged in said housing (12) or casing so as to pass through the penetration area (14) and adapted to be advanced and retracted in opposite directions between an advanced position and a retracted position; Equipped with the system being adapted to inject a substance into a patient's body via the at least one injection needle (11) when the injection needle (11) is in an advanced position; it is not possible to inject a substance into the patient's body via the at least one injection needle (11) when the injection needles (11) are in the retracted position, - the injection needle (11) is inclined to the outer wall at an inclination angle (α) ranging from 10° to 80°; system.

2. a drive unit arranged to advance and retract the at least one injection needle in opposite directions; The system of claim 1 .

3. a tip of the at least one infusion needle penetrates said penetration area upon advancement of the at least one infusion needle; 3. A system according to claim 1 or 2.

4. When the at least one infusion needle is in the retracted position, a tip of the at least one infusion needle extends from the penetration region.

3. A system according to claim 1 or 2.

5. a protective wall is provided on the housing, preferably opposite the distal end of the at least one injection needle, to prevent the tip from coming into contact with the patient's tissue when the at least one injection needle is in its retracted position; The system of claim 4.

6. the at least one infusion needle is laterally displaceable, the penetration area of ​​the outer wall of the housing is provided with a septum through which the at least one infusion needle extends, the septum being laterally movable together with the at least one infusion needle when the at least one infusion needle is laterally displaced, A system according to any one of claims 3 to 5.

7. the outer wall of the housing has an outer surface extending in a first direction, the longitudinal container is arranged adjacent to said outer surface such that the central axis of the longitudinal container extends parallel to the first direction, and the advancement direction of at least one injection needle is arranged in a plane defined by said first direction and said central axis of the longitudinal container at an inclination angle in the range of 10° to 80° with respect to said first direction, A system according to any one of claims 1 to 6.

8. The first direction changes in a curve, The system of claim 7.

9. a holder configured to hold the longitudinal container in position such that a central axis of the longitudinal container extends parallel to the first direction of the outer wall surface of the housing when the at least one injection needle is advanced.

9. A system according to claim 7 or 8.

10. The holder is configured to surround a portion of the longitudinal container such that the container cannot escape from the holder. The system of claim 9.

11. the holder includes a movable lid configured to open and close the holder to position and retain the portion of the longitudinal container within the holder. The system of claim 10.

12. The inclination angle is in the range of 20° to 40°. A system according to any one of claims 1 to 11.

13. a tip portion of at least one injection needle (11), the tip portion including the tip portion (11C) of at least one injection needle (11), is curved in a plane of curvature; A system according to any one of claims 1 to 12.

14. the advancement and retraction of the at least one injection needle (11) in the forward and retraction directions consists of a rotation of a tip portion of the at least one injection needle (11) about an axis of rotation (11E) perpendicular to the plane of curvature, The system of claim 13.

15. The injection needle (11) - a tip (11C) and a hollow body, Preferably, a supply port (11D) is provided on a side wall of the hollow body, and a substance is supplied into the hollow body from this supply port (11D), and an injection port (11A) is provided on the front surface of the tip portion (11C), and the substance is discharged from this injection needle (11) to the outside, - 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) in order to prevent fibrosis from growing within the injection needle (11) when the injection 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 material to pass through the hollow body and out the injection port (11A); 15. A system according to claim 13 or 14.

16. In the advanced position of the stylet (99), the stylet (99) extends from the tip (11C) of the injection needle (11); The system of claim 15.

17. The tip of the stylet is sharp to penetrate the patient's tissue as the at least one injection needle is advanced, 17. The system of claim 16.

18. The tip of the injection needle is blunt, 20. The system of claim 17.

19. The device includes a needle arm (11F) to which the injection 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).

19. A system according to any one of claims 15 to 18.

20. a conduit connected to the needle arm (11F) for supplying the substance to the injection needle (11), the conduit preferably being flexible so that it can follow the movement of the needle arm (11F); 20. The system of claim 19.

21. a drive unit for sequentially carrying out the following steps: - advancing the injection needle (11) and the stylet (99) by rotating the needle arm (11F) and the stylet arm (99F) in an advancing direction about a common axis of rotation (11E); - retracting the stylet (99) in the injection 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 injection needle (11) by rotating the needle arm (11F) in the retracting direction about the common axis of rotation (11E); 21. A system according to claim 19 or 20.

22. The drive unit is configured to perform the following steps before retracting the infusion needle: - rotating the stylet arms about a common axis of rotation in an advancing direction to advance the stylet within the injection needle; 22. The system of claim 21.

23. 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; 23. A system according to any one of claims 19 to 22.

24. the needle arm and the stylet arm being mounted on a carriage movable within the housing or casing to move the tip of the at least one injection needle laterally between different lateral positions; 24. A system according to any one of claims 19 to 23.

25. a second drive shaft extending from the housing or casing, the second drive shaft configured to move a carriage within the housing or casing to move the distal end of the at least one infusion needle laterally between different lateral positions; 25. The system of claim 24.

26. The drive unit is a biasing element (41) for applying a biasing force to bias 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; a release part (43) arranged to release the releasable holder (42) when the injection needle (11) reaches the advanced position, so that the stylet arm (99F) moves away from the needle arm (11F) under the biasing force of the biasing element (41); 26. A system according to any one of claims 21 to 25.

27. the biasing element being a torque spring; 27. The system of claim 26.

28. The torque spring has a square or rectangular cross section; 28. The system of claim 27.

29. One end of the torque spring is attached to the stylet arm and the other end of the torque spring is attached to the needle arm.

29. A system according to claim 27 or 28.

30. one end of the torque spring is attached to the stylet arm and the other end of the torque spring is attached to the housing or casing, or, if the needle arm and the stylet arm are attached to a carriage that is movable within the housing or casing to move the tip of the at least one infusion needle laterally between different lateral positions, mounted to the carriage; 29. A system according to claim 27 or 28.

31. the releasable holder comprises a flexible hook to which the needle arm and the stylet arm are hooked together when the needle arm and the stylet arm rotate in concert with the needle arm about a common axis of rotation in the forward direction, and the release is a deflector configured to deflect the flexible hook laterally to unhook the flexible hook when the infusion needle reaches its forward position or when the infusion needle reaches its forward position; 31. A system according to any one of claims 26 to 30.

32. The drive unit is at least one biasing element providing a biasing force which biases the stylet arm (99F) in either an forward or a backward direction in cooperation with the needle arm (11F) about a common axis of rotation (11E); - a clutch configured to selectively connect at least one of the stylet arm (99F), the needle arm (11F), and both the stylet arm (99F) and the needle arm (11F) to the drive unit; Equipped with 26. A system according to any one of claims 21 to 25.

33. the at least one biasing element provides a biasing force urging the stylet arm in cooperation with the needle arm about a common axis of rotation in the forward direction, and the clutch is configured to selectively connect the drive unit to the stylet arm; the clutch is configured to selectively connect to the needle arm or to both the needle arm and the stylet arm to retract a stylet in an injection needle towards its retracted position by rotating the stylet arm about the common axis of rotation in a retraction direction, or to retract the injection needle by rotating the needle arm about the common axis of rotation in a retraction direction.

33. The system of claim 32.

34. At least one biasing element comprises a torque spring.

34. The system of claim 33.

35. The torque spring has a square or rectangular cross section; 35. The system of claim 34.

36. A biasing element is provided on each of the needle arm and the stylet arm.

36. A system according to any one of claims 33 to 35.

37. The drive unit is a needle crank arm (11G) connected at one end to the needle arm (11F) and at its other end to the needle guide passage (11H) in such a way that the movement of the needle crank arm (11G) along the needle guide passage (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; Equipped with 26. A system according to any one of claims 21 to 25.

38. the drive unit further comprising at least one cam including a needle cam path and a stylet cam path; - The needle crank arms are connected to the needle cam path such that movement of the cam causes the needle arms to rotate about a common axis of rotation. - the stylet crank arms are connected to the stylet cam pathway such that rotation of the cams causes the stylet arms to rotate about a common axis of rotation; 38. The system of claim 37.

39. At least one cam is a cam disc rotatable about a central axis.

39. The system of claim 38.

40. wherein the needle arm and the stylet arm are mounted on a carriage that is movable within the housing or casing to move the distal end of the at least one infusion needle laterally between different lateral positions, the carriage being rotatably mounted within the housing or casing; 40. The system of claim 39.

41. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) adapted to be implanted in a patient's body, said housing (12) having an outer wall with a penetration region (14); at least one injection needle (11) arranged in said housing (12); a drive unit arranged for advancing and retracting the at least one injection needle (11) in opposite directions such that, upon advancement of the at least one injection needle (11), a tip (11C) of the at least one injection needle (11) penetrates said penetration area (14) and a substance can be injected from said penetration area (14) via the at least one injection needle (11); Equipped with an injection port (11A) is provided on the side of the at least one injection needle (11), said injection port (11A) being spaced less than 2 mm from the tip (11C) of the at least one injection needle (11); the injection port (11A) has an extension transverse to the longitudinal direction of the at least one injection needle (11), which extension is greater than the extension of the injection port (11) in the longitudinal direction of the at least one injection needle (11); system.

42. the injection port is spaced less than 1 mm from the tip of at least one injection needle; 42. The system of claim 41.

43. The injection port is spaced 0.5 to 1 mm from the tip of at least one injection needle; 43. A system according to claim 41 or 42.

44. the injection port has an extension of 0.5 mm or less in the longitudinal direction of the injection needle; 44. A system according to any one of claims 41 to 43.

45. the injection port has an extension in a direction perpendicular to the longitudinal direction of the injection needle that is greater than an extension of the injection port in the longitudinal direction of the injection needle; 45. A system according to any one of claims 41 to 44.

46. an injection needle (11) having an injection port (11A) on its side, the injection port (11A) being spaced less than 2 mm from the tip end of the injection needle (11); injection needle.

47. The injection port is spaced less than 1 mm from the tip of the injection needle; 47. An injection needle as claimed in claim 46.

48. The injection port is spaced 0.5 to 1 mm from the tip of the injection needle; 48. An injection needle according to claim 46 or 47.

49. the injection port has an extension of 0.5 mm or less in the longitudinal direction of the injection needle; 49. An injection needle according to any one of claims 46 to 48.

50. the injection port has an extension perpendicular to the longitudinal direction of the injection needle that is greater than the extension of the injection port in the longitudinal direction of the injection needle; 50. An injection needle according to any one of claims 46 to 49.

51. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) adapted for implantation within a patient's body, said housing (12) having an outer wall with a penetration region (14); at least one injection needle (11) arranged in said housing (12); a drive unit arranged for advancing and retracting the at least one injection needle (11) in opposite directions such that, upon advancement of the at least one injection needle (11), a tip (11C) of the at least one injection needle (11) penetrates the penetration area (14) and a substance can be injected from the penetration area (14) via the at least one injection needle (11); Equipped with an injection port (11a) is provided in the side of at least one injection needle (11); when the at least one injection needle (11) is in the retracted position, a tip (11C) of the at least one injection needle (11) is located within the tube, and the inner surface of the tube and the outer surface of the at least one injection needle (11) are fluid-tight sealed relative to each other to prevent infiltration of fluids through the tube into said injection port (11A); system.

52. an inner diameter of the inner surface of the tube and an outer diameter of the outer surface of the at least one injection needle match each other to provide a fluid-tight seal against each other to prevent infiltration of fluids through the tube and into the injection port; 52. The system of claim 51.

53. one or both of the inner surface of the tube and the outer surface of the at least one injection needle are made of a ceramic material; 53. A system according to claim 51 or 52.

54. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: An injection needle (11) having an injection port on its side, an injection needle (11) arranged to advance and retract in opposite forward and retract directions; When the injection needle (11) is in the retracted position, the tip (11C) of the injection needle (11) is located within the tube; When the injection needle (11) is in the forward position, the tip (11C) of the injection needle (11) extends from the tube so that a substance can be injected into the patient's body through the injection port (11A) of the injection needle (11); the inner diameter of the inner surface of the tube and the outer diameter of the outer surface of the injection needle (11) match each other so as to provide a fluid-tight seal against each other to prevent infiltration of fluid through the tube into the injection port (11A) when the injection needle (11) is in the retracted position; system.

55. one or both of the inner surface of the tube and the outer surface of the injection needle (11) are made of a ceramic material; 55. The system of claim 54.

56. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) adapted for implantation in a patient's body, said housing (812) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit arranged to advance and retract the at least one injection needle (11) in opposite forward and retraction directions such that, upon advancement of the at least one injection needle (11), a tip (11c) of the at least one injection needle (11) penetrates said penetration area (14) so ​​as to be able to inject a substance via the at least one injection needle (11) through said penetration area (14); Equipped with - said through area (14) is at least partially made of an elastic material and has predefined therein a passage (14A) for the passage of at least one injection needle (11), said passage (14A) being normally closed by elastic forces generated by the elasticity of the elastic material; system.

57. When the infusion needles are advanced, a passageway automatically opens for at least one infusion needle to pass through.

57. The system of claim 56.

58. the passageway having a flared entrance portion at which the passageway is normally open for entry of the at least one injection needle into the passageway; 58. A system according to claim 56 or 57.

59. When the at least one injection needle (11) is in its retracted position, a tip (11C) of the at least one injection needle (11) is inside said passage (14A); 59. A system according to any one of claims 56 to 58.

60. The passage (14A) is configured as a slit having a longitudinal extension and a lateral extension.

60. A system according to any one of claims 56 to 59.

61. a compressor configured to act on opposite sides of the elastic material on opposite sides of the lateral extension of the slit so as to open a passage for the at least one infusion needle when the infusion needle is advanced, 61. The system of claim 60.

62. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing for implantation inside a patient's body, the housing having an outer wall with a penetration; at least one injection needle arranged in the housing; a drive unit arranged to advance and retract the at least one injection needle in opposite directions such that, upon advancement of the at least one injection needle, the tip of the at least one injection needle penetrates said penetration portion and a substance can be injected through said penetration portion via the at least one injection needle; an injection port is provided on the side of at least one injection needle, said injection port having rounded or chamfered edges at the transition between the injection port and the side; system.

63. rounded or chamfered edges are provided at least on opposite sides of the injection port, an imaginary connecting line between said opposite sides of the injection port running along the advancement direction of the injection needle, 63. The system of claim 62.

64. an injection port on its side, said injection port having a rounded or chamfered edge at the transition between the injection port and the side; injection needle.

65. the injection needle extends in a longitudinal direction and is provided with a rounded or chamfered edge at least on the opposite side of the injection port, and an imaginary connecting line between said opposite edges of the injection port extends along the longitudinal direction of the injection needle, 65. An injection needle as claimed in claim 64.

66. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) adapted for implantation within a patient's body, said housing (12) having an outer wall with a penetration region (14); at least one injection needle (11) arranged in said housing (12) so as to pass through a penetration area (14); a drive unit arranged for advancing and retracting the at least one injection needle (11) in opposite forward and retraction directions between an advanced position and a retracted position, the drive unit being adapted to inject a substance into the patient's body via the at least one injection needle (11) when the at least one injection needle (11) is in the advanced position and being unable to inject a substance into the patient's body via the at least one injection needle (11) when the at least one injection needle (11) is in the retracted position; Equipped with The injection needle (11) - a tip (11C) and a hollow body, the tip (11C) being provided with an injection port (11A) on the front side of the tip (11C) through which a substance can be dispensed outside 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 injection needle (11) when the injection 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 material to pass through the hollow body and out the injection port (11A); Equipped with system.

67. A supply port (11D) is provided on the side wall of the hollow body, through which a substance is supplied into the hollow body, and an injection port (11A) is provided on the front surface of the tip end (11C), through which a substance is discharged to the outside of the injection needle (11); 67. The system of claim 66.

68. In the advanced position of the stylet (99), the stylet (99) extends from the distal end (11C) of the at least one injection needle (11); 68. A system according to claim 66 or 67.

69. a tip (99C) of the stylet (99) being sharpened to penetrate the patient's tissue upon advancement of the at least one injection needle (11); 69. The system of claim 68.

70. The tip (11C) of at least one injection needle (11) is blunt; 70. The system of claim 69.

71. a tip (11C) of the at least one injection needle (11) penetrates said penetration area (14) when the at least one injection needle (11) advances; 71. A system according to any one of claims 66 to 70.

72. when the at least one injection needle (11) is in the retracted position, a tip (11A) of the at least one injection needle (11) extends from said penetration area (14); 71. A system according to any one of claims 66 to 70.

73. said housing (12) is provided with a protective wall (12B), preferably opposite the tip (11C) of the at least one injection needle (11), to prevent the tip (11C) from coming into contact with the patient's tissue when the at least one injection needle (11) is in the retracted position; 73. The system of claim 72.

74. the at least one injection needle (11) is laterally displaceable, the penetration area (14) of the outer wall of the housing constitutes a partition through which the at least one injection needle (11) extends, the partition being laterally movable together with the at least one injection needle (11) when the at least one injection needle (11) is laterally displaced, 74. A system according to any one of claims 66 to 73.

75. Injection needle: a tip and a hollow body, the side wall of the hollow body being provided with a supply port through which a substance is supplied into the hollow body, and the front surface of the tip being provided with an injection port through which the substance is discharged outside the injection needle; the stylet is movable within the hollow body between an advanced position (wherein the stylet is advanced 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 (wherein the stylet is retracted within the hollow body to open a path for material to pass through the hollow body and out the injection port); injection needle.

76. In the advanced position of the stylet, the stylet extends from the tip of the injection needle.

76. An injection needle as claimed in claim 75.

77. The tip of the stylet is sharp to penetrate the patient's tissue as the injection needle advances.

77. An injection needle as claimed in claim 76.

78. The tip of the injection needle is blunt, 78. An injection needle as claimed in claim 77.

79. A tip side portion of the injection needle constituting the tip portion is curved within a curvature plane.

79. An injection needle according to any one of claims 75 to 78.

80. 46. ​​A method of implanting at least one component of the system of any one of claims 1 to 45, comprising the steps of: - Cutting the skin, - removing at least one area of ​​the patient's body at will; - placing a housing containing at least one injection needle in said region in such a way that the tip of the at least one injection needle penetrates the patient's tissue when penetrating the outer wall of the housing, and thus allows the injection of a substance through the at least one penetration region via the at least one injection needle; - closing at least the skin after implanting at least part of the system; The method includes:

81. The method further includes disposing one or more of the following components of the system within the patient's body separate from the housing that contains the at least one injection needle: at least part of the drive unit (D), - a 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 unit (C1); - Feedback sensor (F), - wireless energy conversion means, - an injection port for refilling the reservoir (R1); - at least one tube for injecting the substance to be injected by means of at least one injection needle, 81. The method of claim 80.

82. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) adapted for implantation within a patient's body, said housing (12) having an outer wall with a penetration region (14); at least one injection needle (11) arranged in said housing (12) to pass through the penetration area (14) and adapted to be advanced and retracted in opposite directions between an advanced position and a retracted position; Equipped with said system being adapted to inject a substance into the patient's body via the at least one injection needle (11) when the at least one injection needle (11) is in an advanced position, and wherein it is not possible to inject a substance into the patient's body via the at least one injection needle (11) when the at least one injection needle (11) is in a retracted position, a drive unit (D; 100; 200; 700) arranged to advance and retract at least one injection needle (11) between an advanced position and a retracted position, the tip of the at least one injection needle (11) penetrates said penetration area (14) when the at least one injection needle (11) is advanced, allowing a substance to be injected from said penetration area (14) via the at least one injection needle (11), or the tip of the at least one injection needle (11) protrudes from said penetration area (14) when the at least one injection needle is in a retracted position, Drive unit (D; 100; 200; 700), Equipped with system.

83. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: A housing (12) adapted to be implanted within a patient's body and having an outer wall with a penetration region (14); At least one injection needle (11) arranged in a housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract the at least one injection needle (11) in opposite forward and retraction directions, such that, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration area (14) and allows injection of a substance through said penetration area (14) via the at least one injection needle (11); an external device configured to communicate with an implantable medical device implanted in a patient; Equipped with the external device comprises a display device and a housing unit configured to be mechanically and detachably connected to the display device; the housing unit includes 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; system.

84. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: The device comprises a housing (12) adapted to be implanted inside a patient's body and having an outer wall with a penetration region (14), at least one injection needle (11) arranged within the housing (12), and a drive unit (D; 100; 200; 700) configured to advance and retract the at least one injection needle (11) in opposite forward and retraction directions, such that, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration region (14) and a substance can be injected through said penetration region (14) via the at least one injection needle (11). An implantable controller for an implantable medical device, comprising: a wireless transceiver for wirelessly communicating with an external device; a security module; and communication between the wireless transceiver, the security module and the implantable medical device, wherein the wireless transceiver is configured to receive a communication from the external device including at least one instruction to the implantable medical device, and to transmit the received communication to a 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 is configured to at least one of decrypt at least a portion of the secure communication and verify authenticity of the secure communication, the security module is configured to transmit a response communication to the central unit, the central unit is configured to communicate the at least one instruction to the implantable medical device, the at least one instruction being based on the response communication or a combination of the response communication and the communication received from the external device. system.

85. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising:

1. An implantable medical device adapted to be implanted in a patient's body, comprising: a housing (12) having an outer wall with a penetration area (14), at least one injection needle (11) arranged in the housing (12), a drive unit (D; 100; 200; 700) configured to advance and retract the at least one injection needle (11) in opposite forward and retraction directions, whereby, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration area (14) and allows for injection of a substance through said penetration area (14) via the at least one injection needle (11), and a receiving unit, the receiving unit comprising: at least one coil configured to receive energy to be transmitted transcutaneously, a variable impedance electrically connected to the coil, a switch arranged between the variable impedance and the coil and configured to turn off the electrical connection between the variable impedance and the coil, and a controller configured to control the variable impedance to vary the impedance and thereby adjust the coil based on a measured parameter, and to control the switch to turn off the electrical connection between the variable impedance and the coil in response to the measured parameter exceeding a threshold. system.

86. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: The device comprises a housing (12) adapted to be implanted in a patient's body and having an outer wall with a penetration region (14), at least one injection needle (11) arranged in the housing (12), and a drive unit (D; 100; 200; 700) configured to advance and retract the at least one injection needle (11) in opposite forward and retract directions, whereby, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration region (14) and injects a substance through said penetration region (14) via the at least one injection needle (11). and an implantable medical device comprising a receiving unit, the receiving unit comprising: at least one coil configured to receive transcutaneously transmitted energy; a coil; a first switch disposed at a first end of the coil and a second switch disposed at a second end of the coil, the coil being capable of completely disconnecting from other portions of the implantable medical device; and a controller configured to control the first switch and the second switch to completely disconnect the coil from other portions of the implantable medical device based on a measured parameter. system.

87. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising:

1. An implantable medical device adapted to be implanted inside a patient's body, comprising: a housing (12) having an outer wall with a penetration area (14), at least one injection needle (11) arranged in the housing (12), a drive unit (D; 100; 200; 700) configured to advance and retract the at least one injection needle (11) in opposite advancement and retraction directions, whereby, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration area (14) and allows injection of a substance through said penetration area (14) via the at least one injection needle (11), and a receiving unit, the receiving unit comprising: at least one coil configured to receive transcutaneously transmitted energy, a coil and a controller, the receiving unit configured to receive the transcutaneously transmitted energy in pulses according to a pulse pattern, the measuring unit configured to measure a parameter related to the pulse pattern, and the controller configured to control the receiving unit in response to a deviation of the pulse pattern of the received energy from a predefined pulse pattern. system.

88. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: the system comprises a housing (12) adapted to be implanted in a patient's body and having an outer wall with a penetration region (14), at least one injection needle (11) arranged in the housing (12), a drive unit (D; 100; 200; 700) configured to advance and retract the at least one injection needle (11) in opposite forward and retraction directions, whereby, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration region (14) and allows for injection of a substance through said penetration region (14) via the at least one injection needle (11); providing instructions to be transmitted to an implantable part of the at least partially implantable system, deriving a checksum from the instructions, electronically signing the instructions, the checksum forming a data packet from the instructions, the electronic signature and the checksum, the external system comprising a wireless transmitter configured to wirelessly transmit the data packet to the implantable part of the at least partially implantable system, system.

89. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: The device comprises a housing (12) adapted to be implanted in a patient's body and having an outer wall with a penetration area (14), at least one injection needle (11) arranged in the housing (12), a drive unit (D;100;200;700) configured to advance and retract the at least one injection needle (11) in opposite forward and retraction directions, such that, upon advancement of the at least one injection needle (11), a tip of the at least one injection needle (11) penetrates said penetration area (14) and allows injection of a substance through said penetration area (14) via the at least one injection needle (11), a wireless receiver configured to receive data packets wirelessly transmitted from an external system, and a calculation unit (D;100;200;700) configured to verify electronic signatures and verify integrity using checksums provided in the data packets. system.

90. a needle cooperating member (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), the needle cooperating member (13; 113; 213; 713) further comprising a cross guide (15; 115; 215; 715) to which the needle cooperating member (13; 113; 213; 713) is coupled so as to be movable to different positions in a displacement direction different from the advancement direction and the retraction direction, 90. A system according to any one of claims 82 to 89.

91. the device comprises two linear bearings (102) arranged in parallel, and a translation frame (103) connecting the two linear bearings (102) and arranged to move along the two linear bearings (102) in the forward and backward directions of the at least one injection needle (11) such that the at least one injection needle (11) is advanced or retracted or both advanced and retracted by the movement of the translation frame (103); 90. A system according to any one of claims 82 to 89.

92. a drive unit (100; 200; 700) comprising an advancement cable (130; 230; 730), the advancement or retraction of at least one injection needle (11) being caused by pulling the advancement cable (130; 230; 730), the advancement cable (130; 230; 730) forming part of a block and tackle set-up; 90. A system according to any one of claims 82 to 89.

93. the drive unit (200) comprises a combination of an advance / retract cable (230) and a displacement cable (230) arranged so as to be able to both cause the advance / retraction of the at least one infusion needle (11) by pulling the advance / retract cable (230) and cause the displacement of the at least one infusion needle (11) in a displacement direction different from the forward direction, 90. A system according to any one of claims 82 to 89.

94. At least one injection needle (11) comprises a tubular needle body having a tip portion (11C); an injection port (11A) arranged at the tip (11C) to allow injection of a substance via at least one injection needle (11); a delivery port (11D) located at a distance from the distal end (11C) so as to receive the substance to be injected; a needle lumen inside the tubular needle body connecting the injection port (11A) and the supply port (11D); Equipped with The supply port (11D) is a side port disposed on the side of the tubular needle body; 90. A system according to any one of claims 82 to 89.

95. An injection port (11A) is provided on the side of the at least one injection needle (11), and the injection port (11A) is spaced less than 2 mm from the tip (11C) of the at least one injection needle (11).

90. A system according to any one of claims 82 to 89.

96. the outer wall of the housing (12) has an outer surface (12A) extending in a first direction, a vertical container (V) is positionable adjacent to said outer surface (12A) and a central axis (VA) of the vertical container (V) is configured to extend parallel to said first direction, and the forward and backward directions of the at least one injection needle (11) are arranged in a plane defined by said first direction and the central axis (VA) of the vertical container (V) at an inclination angle (a) to said first direction, said inclination angle (a) being in the range of 10° to 80°; 90. A system according to any one of claims 82 to 89.

97. When the at least one injection needle (11) is in a retracted position, a tip (11C) of the at least one injection needle (11) is disposed within the tube, and an inner surface of the tube and an outer surface of the at least one injection needle (11) are fluid-tight sealed to each other to prevent fluid from entering the injection port (11A) through the tube.

90. A system according to any one of claims 82 to 89.

98. the through-hole area (14) is at least partially made of an elastic material and is provided with a passage (14A) for the passage of the at least one injection needle (11), the passage (14A) being normally closed by an elastic force generated by the elasticity of the elastic material; 90. A system according to any one of claims 82 to 89.

99. At least one injection needle (11) is provided with an injection port (11A) on its side, said injection port (11A) having rounded or beveled edges at the transition between the injection port (11A) and the side, 90. A system according to any one of claims 82 to 89.

100. the injection needle (11) comprises a tip portion (11C) and a hollow body, the tip portion (11C) being provided at its front with an injection port (11A) through which a substance can be injected outside the injection needle (11); the stylet (99) is movable within the hollow body between an advanced position (wherein the stylet (99) advances within the hollow body to close the injection port (11A) and prevent fibrosis from growing within the injection needle (11) when the injection needle (11) is implanted in a patient) and a retracted position where the stylet (99) retracts within the hollow body to open a path for the substance to flow through the hollow body and out of the injection port (11A); 90. A system according to any one of claims 82 to 89.

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