Drug Delivery Systems

Abstract

The present disclosure provides an at least partially implantable system for injecting a substance into a patient's body, comprising: - a housing (12) for implantation within a patient's body, the housing having an outer wall with a penetration region (14); - at least one injection needle (11) arranged in the housing; - a drive unit (D; 100; 200; 700) 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, a tip of the at least one injection needle penetrates said penetration area and a substance can be injected through said penetration area via the at least one injection needle.

Description

[Technical field]

[0001] The present invention relates generally to the injection 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 WO2010 / 040548A1, which is designed in particular for stimulating penile erection. According to the teachings of WO2010 / 040548A1 and the invention described below, the infusion needle is movably arranged in the housing so that it can be advanced to penetrate the outer wall of the housing with its tip. By arranging the infusion needle in this way in the housing, it is possible to prevent the infusion needle from developing fibrosis. However, frequent puncturing of the same body site can cause inflammation and eventually make further puncturing difficult or even impossible. Therefore, multiple infusion needles, or a single infusion needle that can be displaced laterally, are provided so that the outer wall of the housing can be punctured at different puncture sites. This allows the injection site to be varied, with different injection sites being pierced at different times, thereby giving the body tissue time to recover from the penetration by the injection needle. A drive unit is provided for the advancement and retraction as well as the laterally displacement of the infusion needle accordingly. Part of the drive unit may be provided for implantation at a location remote from the infusion area and may consist of a pull wire for triggering the movement of the infusion needle when pulling the remote end of the wire. More specifically, by pulling the wire, the tip of the infusion needle may be displaced laterally from the first puncture site to the second puncture site. A single pull wire may be sufficient to trigger the movement of the infusion needle in one direction, while a spring element urges the infusion needle back to the starting position, or two pull wires may be provided to move the infusion needle back and forth. Further pull wires may be arranged to advance and retract the infusion needle, and again a spring element may be provided to urge the infusion needle back to the starting position. The system may further include a drive unit or part of the drive unit, e.g. one or more electric motors provided inside and / or outside the housing for driving the wire or wires, and may further include at least one reservoir adapted for implantation in the patient's body and in fluid communication with the injection needle or needles to supply the injection needle with the substance to be injected.A pump, also adapted for implantation within the patient's body, may also be provided for pumping the substance from the reservoir to the infusion or injection needle.

[0003] As mentioned above, also in WO2010 / 040548A1, according to the present disclosure, the drive unit is configured to advance and retract the infusion needle. In WO2010 / 040548A1, this is generally achieved by slidably mounting the infusion needle and biasing it back to a rest position by a return spring. However, there is no specific disclosure in WO2010 / 040548A1 as to how the drive should be configured to achieve this. As further noted above, also in WO2010 / 040548A1, according to the present disclosure, the drive unit is configured to laterally displace the distal end of the infusion needle to different puncture sites or to actuate different ones of a plurality of infusion needles. In WO2010 / 040548A1, this is generally achieved by mounting the infusion needle on a moveable carriage, such as a turntable and / or slide. However, again, there is no specific disclosure in WO2010 / 040548A1 as to how the drive unit should be configured to achieve this.

[0004] It is therefore an object of the present disclosure to provide an improved drive for moving an infusion needle, such as in an advancement / retraction direction, a lateral displacement direction, or both an advancement / retraction direction and a lateral displacement direction.

[0005] As mentioned above, in WO2010 / 040548A1, multiple injection needles may also be provided in accordance with the present disclosure, and in WO2010 / 040548A1 valves are used to distribute the substance to be injected to each of the multiple injection needles, which requires valve actuation and complicates the operation of the system.

[0006] Therefore, another object of the present disclosure is to facilitate a method for supplying the substance to be injected to each individual injection needle when the system is comprised of multiple injection needles. Summary of the Invention

[0007] Thus, an at least partially implantable system for injecting a substance into a patient's body according to the present disclosure comprises: - a housing adapted to be implanted within a patient's body, the housing having an outer wall with a penetration region; - at least one infusion needle disposed within the housing; - a drive unit arranged to advance and retract the injection needle or multiple injection needles in a reverse advance / retract direction such that, on advancement, a tip of the injection needle or multiple injection needles penetrates said penetration area so that a substance can be injected through the penetration area via the injection needle or multiple injection needles.

[0008] In this context, the penetration of the penetration area by the tip as the infusion needle advances does not necessarily mean that the tip is present inside the housing, spaced apart from the inner side of the outer wall of the housing, prior to such advancement. Rather, the infusion needle may even penetrate the wall such that its tip extends into the outer wall prior to its advancement and extends from the outer side of the wall upon advancement. This is at least an option in embodiments in which the infusion needle is not laterally displaced during successive injection cycles.

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

[0010] According to a first aspect of the present disclosure, the system may further comprise a needle cooperating member arranged to cooperate with the at least one infusion needle 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 and retraction directions. Advancement or retraction of the infusion needle may thus involve a prior lateral movement of the needle cooperating member along the cross guide to a position of a different injection site.

[0011] Preferably, the cross guide is fixedly held between two opposed fixed points to provide a structure having sufficient rigidity to ensure proper alignment of the needle cooperating member with respect to the injection site, independent of the position of the needle cooperating member on or relative to the cross guide. To this end, the cross guide may consist of a shaft on which the needle cooperating member is slidably mounted.

[0012] The cross guide preferably extends in a displacement direction perpendicular to the direction of advancement and retraction of the needle or needles, but may also extend in a direction oblique to the direction of advancement and retraction of the needle or needles if the space in which the housing is implanted within the patient's body so requires.

[0013] Preferably, the system comprises a translation frame arranged to move in the needle advancement and retraction directions, 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 needle advancement and retraction directions to advance or retract the needle. Preferably, the arrangement is such that a single needle is advanced or retracted upon movement of the translation frame.

[0014] In case 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.

[0015] More specifically, the needle cooperating member can be arranged to act on the array of infusion needles so as 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, i.e. in a rest position, the needle cooperating member can be spaced apart from the infusion needles and can engage with 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 retract directions, the needle cooperating member being preferably arranged to advance each one of the infusion needles by pushing in the forward direction.

[0016] 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.

[0017] Preferably, the arrangement is such that, when the positioning part and the needle drive part are engaged, the positioning part is moved in the displacement direction along the secondary cross guide member, whereby the needle drive part is also moved in the displacement direction along the primary cross guide to a desired position, and, when the needle drive part is positioned, the engagement between the needle drive part and the positioning part is released and the needle drive part can be moved in a forward or backward direction such that the needle drive part cooperates with a respective one of the infusion needles of the array of infusion needles.

[0018] A displacement cable, which will be described in more detail below, is provided for pulling the needle cooperating member in a displacement direction along the cross guide and may be connected to a positioning portion of the needle cooperating member.

[0019] If the at least one infusion needle consists only of a single infusion needle, the single infusion needle may be attached to the needle cooperating member such that it is movable in the displacement direction together with the needle cooperating member. The single infusion needle may be welded or potted to the needle cooperating member so as to hold the infusion needle securely in place.

[0020] The single infusion needle may have a curved portion attached to the needle cooperating member. This may facilitate mounting the infusion needle in the correct position 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 it is advanced with its front end through the penetration area of ​​the wall of the housing.

[0021] 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 area in the wall of the housing.

[0022] Finally, a tube for supplying the substance to be injected through the single injection needle may be connected to the end of the single injection needle and looped inside the housing to allow the necessary range of motion of the tube.

[0023] 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 needles 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 needles or needle cooperating member in different lateral displacement directions.

[0024] The motor may be located within the housing in which the needle is 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 that case, one or more pull cables may be provided extending within the housing from one or more motors located remotely within or even outside the patient's body to transfer kinetic energy into the housing for moving the needle or needles located within the housing. One or more cables or belts may also be provided within the housing to transfer energy between components located within the housing.

[0025] 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, are provided to bias the needle or needles back to the rest position, the arrangement may also be reversed, such that the motor or cable is arranged to retract the infusion needle or needles to the rest position and resilient means, e.g. a spring element, are provided to advance the needle or needles to the activated position.

[0026] In all embodiments where a cable is employed, the cable is preferably a Bowden cable so that it can transmit pulling forces while still being flexible. This is particularly advantageous where part of the drive is remote from the housing and the cable runs into the housing from a remotely located motor.

[0027] Although a cable is usually understood to be composed of a set of wires that are covered, a cable in the sense of this disclosure may be composed of one or more wires, uncovered or preferably covered, such as a single uncovered wire, a single covered wire, a set of uncovered wires, a set of covered wires, or a set of covered wires. The wires are preferably metallic, but may alternatively be composed of or include one or more polymer wires.

[0028] 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.

[0029] In a first embodiment, the tension spring may be arranged to provide a counter force against the tension of the displacement cable which may act 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 in the absence of the tension of the displacement cable acting on the needle cooperating member. That is to say, when, after a certain number of injections, the needle cooperating member has been displaced step by step relative to the cross guide to reach its final position, the tension of the displacement cable can be released and the needle cooperating member can be returned to its starting position by the reaction force of the tension spring.

[0030] It is advantageous if 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, independent of the position of the needle cooperating member relative to the cross guide. For example, the tension spring may consist of a metal band which winds itself around 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, when 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 drawing the needle cooperating member back to its starting position. Preferably, the tension spring provides a tension force between 0.5 N and 2 N, preferably between 0.8 N and 1.2 N, most preferably about 1 N.

[0031] In a second embodiment, the displacement cable or belt can be arranged to pull the needle cooperating member along the cross guide in the opposite first and second displacement directions. In this case, no tension spring is required as the needle cooperating member can be returned to its starting position by the displacement cable. 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.

[0032] Preferably, the displacement cable or belt is endless, for example in the form of a loop that runs from the first wheel to the second wheel, wraps around the second wheel by 180°, or preferably wraps around 180° and rotates several more full revolutions to prevent slippage of the cable or belt, and runs back from the second wheel to the first wheel, wraps around the first wheel by 180°, or also preferably wraps around 180° and rotates several more full revolutions, and the needle interaction member then moves in the first and second displacement directions depending on the direction of rotation of the first and second wheels.

[0033] A tensioning element may be provided for generating tension in the displacement cable or belt transversely to the longitudinal axis of the displacement cable or belt so as to reduce slack in the displacement cable or belt.

[0034] A motor may be located inside or outside the housing to provide power to rotate the first or second wheel. However, as mentioned above, if the motor cannot be mounted on the housing because of limited space for embedding and therefore the housing must be kept small, it is preferable to locate a drive cable to rotate the first or second wheel, which accordingly extends outside the housing and is connected to a remote motor. In this case, the drive cable is connected to one of the first and second wheels and can be wound on or off the first or second wheel, or wrapped around the first or second wheel.

[0035] Alternatively, at least one of the first and second wheels may be mounted on a drive shaft for rotation by rotation of the drive shaft, and a drive cable may be connected to the drive shaft for driving the drive shaft, in which case a third wheel may be mounted on the drive shaft, and the drive cable may wrap around, off, or around the third wheel.

[0036] 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.

[0037] 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 when the needle cooperating member is moved to different positions along the cross guide, the first and second alignment structures engage with each other and define different stationary positions of the needle cooperating member. This arrangement supports accurate positioning of the needle cooperating member.

[0038] 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 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 spring is urged rearwardly to disengage from the detents or protrusions and then snaps forward again to re-engage one or more adjacent detents or protrusions.

[0039] According to a second aspect of the disclosure, the system comprises 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 forward and retraction directions of at least one infusion needle, the respective movements of the translation frame causing the infusion needle to be advanced or retracted or both advanced and retracted. Most preferably, the above-mentioned cross guide, to which the needle cooperating member is coupled, is fixed to the translation frame and is movable together with the translation frame in the forward and retraction directions of the needle. The provision of two parallel linear bearings increases the stability and precision of the system. The two linear bearings preferably take the form of two parallel shafts on which the translation frame is slidably mounted.

[0040] 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.

[0041] The drive unit may include an advancement cable arranged to advance or retract at least one infusion needle by pulling the advancement cable. For example, the advancement cable may be arranged to move the translation frame in an advancement and retraction direction along at least one linear bearing, thereby advancing and / or retracting the infusion needle. The advancement cable may be guided through a wall of the housing towards a motor located at a location outside the patient away from the housing, more preferably somewhere inside the patient.

[0042] According to a third aspect of the present disclosure, the advancement cable can form part of a block-and-tackle setup. This reduces the amount of power required to advance the needle or needles through the penetration area in the wall of the housing. Thus, the motor for driving the advancement cable can be relatively small.

[0043] If an advancement cable is arranged to move the translation frame along the linear bearing or bearings in a forward and reverse direction, the block and tackle setup may consist of at least one first pulley, preferably two first pulleys, fixed to the translation frame to move with the translation frame, and at least one second pulley, preferably two second pulleys, fixed to the housing 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 that moves with the translation frame, thereby splitting the pulling force required to move the translation frame in two.

[0044] 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 the at least one infusion needle and displacement of the at least one infusion needle in a displacement direction different from the advance / retract direction by pulling the advance / retract cable. For example, a first actuator may be attached to a first end of the advance / retract cable and a second actuator may be attached to a second end of the advance / retract cable, the first actuator being arranged to pull and move the advance / retract cable in a first pulling direction, and the second actuator being arranged to pull and move the advance / retract cable in a second pulling direction opposite to the first pulling direction.

[0045] 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.

[0046] In this case, when the advance / retract cable is arranged to move the translation frame along the linear bearing or bearing in an advance / retract direction, the movement of the advance / retract cable in the opposite first and second pulling directions can move the translation frame along the linear bearing or bearing. This can be achieved, for example, by at least two first pulleys fixed to the housing so as to be stationary, in which case the advance / retract cable is guided on one of the two first pulleys fixed to the housing and further on the translation frame and further on 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 the opposite first and second pulling directions over the same distance, the translation frame is pulled along the linear bearing or bearing in a direction towards the two first pulleys, such as the advance direction of the infusion needle or needle. The block and tackle set-up described above may be similarly provided for the advancement and displacement cables, however in this case this is less critical as twice the power is available as not only one motor but two motors may be used, 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 such that when the pulling force on the advancement and displacement cables is reduced the return springs automatically return the translating frame to the rest position.

[0047] 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.

[0048] In this case, when the system consists of said needle cooperating member, to which at least one infusion needle is attached, and said cross guide, to which the needle cooperating member is coupled, the forward and backward displacement cable can be connected to the needle cooperating member so as to pull and move the needle cooperating member 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 member, the forward and displacement cables being guided on the two second pulleys. Thus, when the forward and displacement cables are pulled in one or the other pulling direction, the needle cooperating member is pulled accordingly along the cross guide towards a respective one of the two second pulleys, i.e. in the displacement direction of the infusion needle.

[0049] 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 a central portion fixedly connected to the needle cooperating member.

[0050] 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 a forward or retraction direction and to individually displace a needle cooperating member in respective opposite displacement directions.

[0051] In particular, in this fourth embodiment, the at least one injection needle may be composed of only a single injection 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 injection needle may be welded or potted to the needle cooperating member, or may have a curved portion by being attached to the needle cooperating member, and the curved portion may be fixedly held in a corresponding curved recess of the needle cooperating member. In addition, in order to minimize the deflection of the injection needle when penetrating the penetration area of ​​the wall of the housing, a needle reinforcement tube may be arranged around the single injection needle, and a tube for supplying the substance to be injected through the single injection needle may be connected to the end of the single injection needle and looped in the housing so as to have a required range of motion.

[0052] According to a fifth aspect of the present disclosure, the at least one infusion needle may comprise a tubular needle body having a distal end, an injection port arranged at the distal end so as to be able to inject a substance through the at least one infusion needle, a supply port arranged at a position away from the distal end so as to be able to receive the substance to be injected, and a needle lumen inside the tubular needle body connecting the injection port and the supply port, the supply port being a lateral port arranged at a 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 may be used and particularly adapted to move the infusion needle in the forward or backward direction. While this aspect is certainly applicable in cases where there is only a single infusion needle such that only a single supply lumen is required, this aspect may also be advantageously employed in systems consisting of multiple infusion needles. In general, when multiple needles are provided, the infusion needles may be spaced apart from each other by a distance between 1 mm and 2 mm, preferably 1.5 mm.

[0053] In either case, the system may include an internal reservoir within the housing that is positioned to hold the substance to be injected, and when the infusion needle is in an advanced position penetrating the penetration area, the supply port is positioned within the internal reservoir and the injection port is positioned outside the housing. Thus, in this position, a substance such as an infusion solution can enter the infusion needle through a supply port positioned on the side of the tubular needle body, and when an 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 penetrating the penetration area with each supply port located inside the internal reservoir and each injection port located outside the housing.

[0054] Preferably, the piercing area is constituted by a septum and the internal reservoir is arranged 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 dimensions of the internal reservoir within the septum may be such that when the infusion needle is in the retracted position, the supply port is located within the internal reservoir. This is advantageous to ensure that the needle lumen is filled with substance from the internal reservoir before the infusion needle moves from the retracted position to the advanced position. Again, in the case of multiple infusion needles, each infusion needle is arranged in this way, preferably side-by-side.

[0055] More preferably, the injection port at the tip of the injection needle can also be located inside the septum when the injection 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 and outside the internal reservoir. In this way, the injection port is also hermetically closed by the material of the septum when the injection needle is not in use and not retracted. Furthermore, such an arrangement increases the stability of the injection needle and provides some guidance for the needle movement. Alternatively, the injection port may be located inside the septum and inside the internal reservoir when the injection needle is in the retracted position. This is also advantageous in order to ensure that the needle lumen is already filled with substance from the internal reservoir before the injection needle moves from the retracted position to the advanced position.

[0056] With regard to the supply lumen for supplying the injection substance to the internal reservoir, if the system is comprised of one or more linear bearings as described above and a translation frame arranged to move in an advancing and retracting direction along the linear bearings, with each movement of the translation frame advancing and retracting the injection needle, the supply lumen can be arranged to run along the inner lumen of the linear bearing. In this way, the overall size of the housing can be kept small. The inner lumen preferably connects directly to the aforementioned internal reservoir.

[0057] Preferably, the injection port of the injection needle is also designed as a side port located at the side of the tubular needle body. Thus, the injection needle is closed at its tip side, and the injection port located at the side is used to deliver the drug to a specific body site. Thus, the injection needle does not cut any material, but simply splits upon penetration. Thus, even if the injection needle penetrates a material such as a septum, which may be in the form of fibrosis and / or a self-sealing penetration membrane, the material does not enter and block the drug delivery passage.

[0058] In all embodiments the maximum size of the housing is 30mm x 40mm x 6mm.

[0059] [communication] According to further aspects of the present disclosure, the security of the system against unauthorized third-party intervention can be increased. This is particularly important in the context of wireless communications that can be easily intercepted and subsequently exploited by third parties. Thus, the system is preferably configured such that at least one of the following occurs: - wireless communications to and from the controllers of the system are encrypted; - Signing data sent from the controller via wireless communication - Authentication of users of the system includes the entry of patient authentication data.

[0060] 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. A further level of security is provided in that the private key may preferably be a composite key derived by combining at least a first key and a second key.

[0061] Similarly, with regard to signing of data transmitted wirelessly from a controller, such as from the external or remote controller described above to the internal controller, the signing may involve a private key and subsequent verification of the signed data may involve a corresponding public key.

[0062] 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. On the other hand, in the signing / authentication process, the sender signs the (encrypted) data using his private key, and the receiver authenticates the signature using the sender's public key.

[0063] Regarding authentication of a user with input of patient authentication data, the system may comprise a verification unit configured to obtain the patient authentication data. For example, the verification unit may comprise at least one of a fingerprint reader, a retina scanner, a camera, a graphical user interface for inputting a code, and a microphone. Only after a positive verification by the verification unit, certain functions of the system are enabled. For example, a 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.

[0064] Alternatively or additionally, the system may include a sensory generator for generating sensations detectable by the patient's senses. In this case, the patient may input authentication data into the system related to what the patient senses. Authentication of 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, only after a positive verification by the verification unit is a particular function of the system enabled. For example, a positive verification may enable a controller to process particular data or open a communication channel between two controllers of the system, such as a wireless communication channel.

[0065] In this context, the sensation generator is configured to generate at least one of the following sensations detectable by the patient's senses: - vibration, which may for example include mechanical vibration of a fixed frequency; - sound, which includes, for example, the superposition of mechanical vibrations of fixed frequencies; - a light quantum signal, which may include a non-visible light pulse, such as an infrared pulse, - Optical signals, including visual light pulses; - Electrical signals, including current pulses, etc. - Thermal signals, for example heat pulses.

[0066] [General Communications / 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.

[0067] According to one embodiment, the external device comprises a portable electronic device.

[0068] 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.

[0069] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device. An advantage of this embodiment is that it allows communication with the display device without the need for wires.

[0070] 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.

[0071] According to one embodiment, the second communication unit is configured to wirelessly communicate with the implantable medical device using electromagnetic waves at a frequency below 100 kHz.

[0072] According to one embodiment, the second communication unit is configured to wirelessly communicate with the implantable medical device using electromagnetic waves with frequencies below 40 kHz. An advantage of this embodiment is that titanium, which is commonly used in medical devices, is transparent to electromagnetic waves below 40 kHz.

[0073] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using electromagnetic waves with frequencies above 100 kHz. An advantage of this embodiment is that the frequency spectrum below 100 kHz remains noise-free in communication with the medical implantable device.

[0074] According to one embodiment, a first communication unit is configured to wirelessly communicate with a display device using a first communication protocol and a second communication unit is configured to wirelessly communicate with an implantable medical device using a second communication protocol, the first and second communication protocols being different. An advantage of the embodiment is that the protocols can be independently selected for communication of the first and second communication units depending on which protocol is more suitable for the needs of the communication units.

[0075] 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 is that the antennas can be independently selected for communication of the first and second communication units depending on which antenna is more suited to the needs of the communication units.

[0076] 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.

[0077] 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.

[0078] 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 a distant device.

[0079] According to one embodiment, the first communication unit of the display device is a wireless communication unit for wirelessly communicating with the housing unit, an advantage of this embodiment being that the communication unit can be connected to the housing unit without the use of wires.

[0080] 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 frequency, and a 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.

[0081] 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.

[0082] 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 can be independently selected for communication of the first and second communication units depending on which antenna is more suited to the needs of the communication units.

[0083] 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 is that the communication of the first communication unit is reliable and secure.

[0084] 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 familiar display device.

[0085] According to one embodiment, the housing unit is adapted to transmit information for displaying 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.

[0086] According to one embodiment, the display device is configured to receive input from the patient for communication with the implantable medical 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.

[0087] According to one embodiment, the display device comprises a touch screen 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 the information in a familiar manner.

[0088] 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 is capable of receiving user input.

[0089] 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 based on the received input to the implantable medical device. 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 the communication to be monitored.

[0090] According to one embodiment, the second communication unit of the housing unit is configured to wirelessly communicate with the implantable medical 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.

[0091] 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.

[0092] According to one embodiment, the second communication unit of the housing unit comprises a Bluetooth transceiver.

[0093] 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 a proprietary network protocol.

[0094] According to one embodiment, the second communication unit of the housing unit is comprised of a UWB transceiver. The advantage is that it is possible to communicate at high data rates via the second communication unit.

[0095] According to one embodiment, the first communication unit of the housing unit is configured to wirelessly communicate with the display device using a standard network protocol, the advantage of this embodiment being that the communication unit is cheap to implement and the protocol is reliable.

[0096] According to one embodiment, the standard network protocol is an NFC type protocol. The advantage of this embodiment is that the distance between the communicating devices is limited, thus providing protection against eavesdropping attacks.

[0097] 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.

[0098] 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 is that energy is saved by selecting the first communication unit when its communication range is sufficient.

[0099] 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.

[0100] 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.

[0101] 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 increased security against man-in-the-middle attacks.

[0102] 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 safety and authorization factor.

[0103] 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 unwanted third party access.

[0104] According to one embodiment, the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit, an advantage of this embodiment being that the encrypted communication is protected from unwanted third party access.

[0105] According to one embodiment, the second communication unit of the display device is configured to be disabled to enable at least one of communication between the display device and the housing unit and communication between the housing unit and the implantable medical device.

[0106] 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.

[0107] 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.

[0108] 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 the 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.

[0109] 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.

[0110] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device.

[0111] 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.

[0112] According to one embodiment, the housing unit is adapted to transmit information related to the display of the user interface to the display device.

[0113] According to one embodiment, the housing unit is configured to receive patient input from a display device.

[0114] According to one embodiment, the housing unit is configured to display a user interface to the patient.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communications received from the display device.

[0119] According to one embodiment, the housing unit is further adapted to transmit the encrypted communication to the implantable medical device using the second communication unit.

[0120] 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.

[0121] 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.

[0122] According to one embodiment, when the display device is mechanically connected to the housing unit, the switch is at least partially covered by the display device.

[0123] According to one embodiment, at least a portion of the housing is flexed to mechanically connect to the display device.

[0124] According to one embodiment, at least a portion of the housing is configured to sandwich a display device.

[0125] 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.

[0126] According to one embodiment, the housing is configured to be mechanically connected to a display device, with the device being mechanically connected to the housing and the display device.

[0127] [General Security Module] Further provided is an implantable controller for an implantable medical device. The implantable controller comprises 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 configured to decrypt at least a portion of the secure communication and / or 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 at least one instruction to the implantable medical device, the at least one instruction being based on the response communication or based on a combination of the response communication and the communication received from the external device.

[0128] According to one embodiment, the security module comprises a rule set for accepting communications from a central device.

[0129] 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.

[0130] According to one embodiment, the set of rules includes a rule that provides that the wireless transceiver will only accept communications from the central unit if it has been placed in an off mode for a specified period of time.

[0131] According to one embodiment, the central device is configured to verify a digital signature of a communication received from an external device.

[0132] 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.

[0133] According to one embodiment, the central unit is adapted to check the size of a communication received from an external unit.

[0134] According to one embodiment, the set of rules includes a rule that provides for accepting a communication from the central unit only if the size of the received communication is verified by the central unit.

[0135] The wireless transceiver of any of the preceding embodiments may be configured to receive a message from an external device that is encrypted with at least a first and a second layer of encryption, and the central unit may be configured to decrypt the first layer of encryption and transmit at least a portion of the message that constitutes the second layer of encryption to the security module. The security module may be configured to decrypt the second layer of encryption and transmit a response communication to the central unit based on the portion of the message decrypted by the security module.

[0136] According to one embodiment, the central unit may be configured to decrypt the portion of the message that includes the digital signature so that the digital signature may be verified by the central unit.

[0137] According to one embodiment, the central unit is configured to decrypt a portion of the message that includes the message size information such that the message size can be verified by the central unit.

[0138] 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 authenticity of the second part.

[0139] According to one embodiment, the response communication sent from the security module may include 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.

[0140] According to one embodiment, the set of rules includes a rule relating to a data transfer rate between the central unit and the security module.

[0141] The security module in any embodiment of the present specification may be configured to decrypt a portion of a message including a digital signature that was encrypted with a second encryption layer such that the digital signature may be verified by the security module.

[0142] The central unit may be configured to only be able to decode some of the communications received from the external unit when the wireless transceiver is placed in the off mode.

[0143] 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 an off mode.

[0144] According to one embodiment, the implantable controller is configured to receive, using a wireless transceiver, a message from an external device including a first unencrypted portion and a second encrypted portion, decrypt the encrypted portion, and use the decrypted portion to verify authenticity of the unencrypted portion.

[0145] According to one embodiment, the central device is configured to send the encrypted portion to the security module, receive a response communication from the security module based on information contained in the encrypted portion being decrypted by the security module, and verify the authenticity of the unencrypted portion using the response communication.

[0146] According to one embodiment, the unencrypted portion comprises at least a portion of at least one instruction for the implantable medical device.

[0147] The implantable controller may be configured to receive, using the wireless transceiver, a message from an external device including 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.

[0148] The patient's physiological parameters may include at least one of body temperature, heart rate, and saturation value.

[0149] The physical or functional parameters of the implanted medical device may include at least one of a current setting or value of the implanted medical device, an advance instruction sent to the implanted medical device, and an ID of the implanted medical device.

[0150] According to one embodiment, portions of the message constituting 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.

[0151] 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.

[0152] 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. The security module may comprise a combination of software-based keys and hardware-based keys in any embodiment.

[0153] In any of the foregoing embodiments, the implantable controller may include at least one cryptographic processor.

[0154] The wireless transceiver, in either embodiment, may be configured to receive communications from a portable external device.

[0155] According to one embodiment, the at least one instruction to the implantable medical device may include an instruction to change an operational state of the implantable medical device.

[0156] The wireless transceiver may be configured to wirelessly communicate with an external device using electromagnetic waves at frequencies below 100 kHz or at frequencies below 40 kHz.

[0157] 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.

[0158] 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.

[0159] The wireless transceiver, in some embodiments, is configured to wirelessly communicate with external devices using a proprietary network protocol.

[0160] According to one embodiment, the wireless transceiver comprises a UWB transceiver.

[0161] According to one embodiment, the security module and / or the central unit and / or the wireless transceiver are configured within the controller.

[0162] 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.

[0163] Further, the implantable medical device may include a receiving unit. The implantable medical device comprises at least one coil configured to receive the transcutaneously transmitted energy, a measuring 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 when the measured parameter exceeds a threshold value.

[0164] According to one embodiment, the controller is configured to vary the variable impedance in response when the measured parameter exceeds a threshold value.

[0165] According to one embodiment, the measurement unit is adapted to measure a parameter related to the energy received by the coil over a period of time.

[0166] According to one embodiment, the measurement unit is adapted to measure a parameter related to the change in energy received by the coil.

[0167] According to one embodiment, a first switch is disposed at a first end of the coil, and the implantable medical device further includes a second switch disposed at a second end of the coil so that the coil can be completely disconnected from other portions of the implantable medical device.

[0168] 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.

[0169] According to one embodiment, the controller is configured to control the variable impedance in response when the pulse pattern deviates from a predefined pulse pattern.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] 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.

[0174] According to one embodiment, the variation in impedance is arranged to reduce the effective power received by the receiving unit.

[0175] According to one embodiment, a variable impedance is placed in series with the coil.

[0176] According to one embodiment, the variable impedance is placed in parallel with the coil.

[0177] 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.

[0178] [Surface coating] A further aspect of the present disclosure relates to mitigating fibrin formation caused by contact of a medical implant, such as the implantable system described above, with a patient's tissue or flowing blood. As is well known, the body tends to react to medical implants, in part because the implant is a foreign body, in part because the implant mechanically interacts with the body's tissues and / or the blood flowing through the body. Implantation of a medical device and / or biomaterial into a patient's tissue can trigger a foreign body response in the body, leading to the formation of foreign body giant cells and the development of a fibrous capsule that encases the implant. The formation of a dense fibrous capsule that isolates the implant from the host is a common underlying cause of implant failure. 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 clotting through fibrin formation, leading to complications for the patient. Implants can also cause bacterial infections when in contact with blood or when placed in the body. One common method of combating the formation of blood clots is the use of various types of blood thinners. One commonly used blood thinner is heparin, but heparin has undesirable side effects.

[0179] In general, fibrin is an insoluble protein produced in part in response to bleeding and is the main component of blood clots. Fibrin is formed by fibrinogen, a soluble protein produced in the liver and present in blood 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 fibrin formation from fibrinogen first attracts platelets. Platelets have thrombin receptors on their surface that bind serum thrombin molecules. These molecules convert soluble fibrinogen to fibrin. Fibrin then forms long chains of tough, insoluble protein that are bound to platelets. Fibrin is then cross-linked, hardening and shrinking. This is made possible by factor XIII, an enzyme present in human blood. Fibrin is also produced by foreign body reactions. When a foreign body is detected in the body, the immune system is attracted to it and tries to break it down. When this degradation goes wrong, an envelope of fibroblasts is produced, creating a physical barrier to isolate the body from the foreign body, which can develop into a fibrin sheath. If the foreign body is an implant, this can interfere with the function of the implant.

[0180] Thus, when implanted in the body, the implant may come into contact with flowing blood. This may result in platelets adhering to the implant surface. Platelets may then convert fibrinogen in the blood into fibrin, creating a sheath on and / or around the implant. This may cause the implant to not function properly and may also result in blood clots that are dangerous to the patient. However, implants that are not in contact with blood may also malfunction due to the production of fibrin. In this case, a foreign body reaction may be the underlying cause of the malfunction. Furthermore, the implantation of a foreign body in the human body may trigger an inflammatory response. This response generally lasts until the foreign body is engulfed in a relatively dense layer of fibrous connective tissue that generally protects the human body from foreign bodies. This process may begin with the implant instantly and naturally acquiring a layer of host proteins. A surface modified with blood proteins allows cells to attach to the surface and allows monocytes and macrophages to interact at 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 fibrotic 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, and in severe cases, to revision surgery.

[0181] Implants can also cause various kinds 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 such as 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.

[0182] Thus, according to this further aspect of the disclosure, in order to mitigate fibrin formation caused by contact between the components of the implantable system described above 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. The biomaterial is preferably fibrin-based. The coating may include at least one drug or substance having antithrombotic and / or antibacterial and / or antiplatelet properties. The drug or substance may be encapsulated in a porous material.

[0183] A second coating may be provided disposed on the first coating. The second coating may be a different biomaterial than said first coating. In particular, the first coating may consist of a layer of perfluorocarbon chemically attached to the surface and the second coating may consist of a liquid perfluorocarbon layer.

[0184] 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.

[0185] 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.

[0186] A further aspect of the present disclosure relates to a method for reliably injecting a medicament 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 advances into the blood vessel and retracts from the blood vessel.

[0187] According to a first sub-aspect of this further aspect, the infusion needle may include an injection port on its side, said injection port being spaced apart from the distal end of at least one of the infusion needles by less than 2 mm, preferably less than 1 mm, more preferably 0.5-1 mm. This is particularly useful when the diameter of the blood vessel to be punctured is small. That is, since 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 a very short distance in order to place the injection port in the blood vessel, thereby preventing the distal end of the infusion needle from extending out of the blood vessel through the opposite vessel wall of the blood vessel. The above 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 has an extension in the longitudinal direction of the infusion needle of 0.5 mm or less, more preferably 0.3 mm or less, even more preferably 0.2 mm or less.

[0188] More preferably, the injection port can have an extension in a direction 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, so that the longitudinal extension of the injection port can be reduced while still keeping its cross-sectional area large, so that upon advancement of the injection needle into the blood vessel, the injection port is completely contained within the lumen of the blood vessel due to its short longitudinal extension.

[0189] 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 region; - at least one injection needle disposed within the housing; 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 said penetration area and a substance can be injected through said penetration area via the at least one infusion needle; wherein the injection needles are designed as described above, i.e. at least one injection needle is provided with an injection port on its side, said injection port being spaced less than 2 mm, preferably less than 1 mm, more preferably 0.5-1 mm from the tip end of the at least one injection needle, preferably less than 0.5 mm, more preferably less than 0.3 mm, even more preferably less than 0.2 mm, and even more preferably having an extension perpendicular to the longitudinal direction of the injection needle that is greater than the longitudinal extension of the injection port of the injection needle.

[0190] According to a second sub-aspect of this further aspect, the infusion needles can be arranged such that, when advanced, they enter the container in an oblique manner, i.e. non-perpendicularly. This can be achieved by arranging the infusion needles such that, when advanced, they do not extend perpendicularly from the housing, but at an oblique angle relative to the outer surface of the housing. For this purpose, the outer wall of the housing of the implantable system can have an outer surface extending in a first direction, which outer surface is configured such that a longitudinal blood vessel, such as a vein or an artery, can be placed adjacent to said outer surface such that the central axis of the longitudinal blood vessel extends parallel to said first direction. And, if the direction of advancement and retraction of at least one infusion needle is in a plane defined by said first direction of the outer wall surface of the housing and said central axis of said longitudinal blood vessel, and is arranged at an oblique angle relative to said first direction, the infusion needles enter the blood vessel at such an oblique angle when advanced and retracted. In other words, the infusion needles are arranged 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. The inclination angle is less than 90°, preferably in the range of 10° to 80°, more preferably in the range of 20° to 40°.

[0191] It is further preferred to provide a holder configured to hold the longitudinal blood vessel in a position relative to the housing such that the central axis of the blood vessel extends parallel to said first direction of the outer surface of the outer wall of the housing when the at least one infusion needle is advanced, 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.

[0192] Preferably, the holder is configured to surround the longitudinal container, or preferably its entire circumference, i.e., the container cannot slip 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 portion of the longitudinal container within the holder.

[0193] Thus, an at least partially implantable system for injecting a substance into a patient's body comprises: - a housing for implantation within a patient's body, the housing having an outer wall with a penetration region; - at least one infusion needle disposed within the housing; - a drive unit arranged to advance and retract the at least one injection needle in a reverse direction such that, upon advancement of the at least one injection needle, a tip of the at least one injection needle penetrates the penetration area and a substance can be injected through the penetration area via the at least one injection needle; Equipped with - the outer wall of the housing has an outer surface extending in a first direction, a longitudinal container can be positioned adjacent to said outer surface, the central axis of the container is configured to extend parallel to said first direction, the direction of advancement and retreat of the at least one injection needle is arranged at an inclined angle to the first direction within a plane defined by said first direction and the longitudinal axis of the container, the inclination angle being within the range of 10° to 80°, more preferably within the range of 20° to 40°, and the system may further include the holder.

[0194] A further aspect of the present disclosure relates to a problem that may arise when the injection needle has an injection port on its side, whereby as the injection needle passes through the diaphragm separating the inside and the outside of the housing, the injection needle pierces the diaphragm and the injection port on the side of the injection needle moves along the material of the diaphragm, e.g. a silicone material or other polymeric material, which may scratch the diaphragm and result in the material of the diaphragm being worn away and carried into the patient's body.

[0195] 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 located in the tube and the inner surface of the tube and the outer surface of the infusion needle are sealed liquid-tight against each other. This results in a sealed injection port, i.e. it is ensured that fluids such as blood are prevented 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 so as to seal liquid-tight against each other to prevent the ingress of fluids through the tube into the injection port, i.e. a sealing surface is constituted by these two surfaces. Preferably, the injection port is located at this sealing part of the infusion needle. In a preferred embodiment, one or preferably both of the inner surface of the tube and the outer surface of the infusion needle - preferably constituting the part 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, which allows a liquid-tight fit to be created between said inner and outer surfaces. And, when the infusion needle and its infusion port are advanced to extend from the tube into the housing, the needle does not have to make a hole to penetrate the wall of the housing. Rather, a hole is already provided in the wall by the tube where the tip of the infusion needle is present. This reduces the risk that material will be scraped off the wall by the edge of the opening of the infusion port as the infusion needle advances. When the infusion needle is in the retracted position, one end of the tube opens to the exterior of the housing, but there is no risk of any body fluids or fibrosis getting into or blocking the needle, because the inner surface of the tube and the outer surface of the infusion needle are or are fluid-tight sealed to each other. Rather, as the needle is advanced to extend from the tube, fibrosis within the tube is pushed out and fibrosis in front of the tube is penetrated by the infusion needle.

[0196] Thus, an at least partially implantable system for injecting a substance into a patient's body comprises: - a housing for implantation within a patient's body, the housing having an outer wall with a penetration region; - 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 such that upon advancement of the at least one infusion needle, a tip of the at least one infusion needle penetrates said penetration area and a substance can be injected through said penetration area via the at least one infusion needle; Equipped with - an injection port is provided on the side of the at least one injection needle, when the at least one injection needle is in the retracted position, a distal end of the injection needle is disposed in the tube, an inner surface of the tube and an outer surface of the at least one injection needle are sealed liquid-tight against each other to prevent ingress of fluids, e.g. ingress of 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 injection needle match each other to seal liquid-tight against each other to prevent ingress 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 injection needle are preferably made of a ceramic material, including the part of the injection needle that constitutes the injection port.

[0197] According to a second sub-aspect of this further aspect, the penetration area of ​​the outer wall of the housing penetrated by the infusion needle is at least partially made of an elastic material in which a passage for the passage of at least one infusion needle is preconfigured, said passage being closed by an elastic force generated by the elasticity of the elastic material, such as silicone or any other elastic polymeric material. Thus, no external force is required to keep the passage closed against the ingress of body fluids or the development of fibrosis. Then, when the infusion needle and its infusion port are advanced through said preconfigured passage, the needle does not have to pierce the wall of the housing in order to penetrate it. Rather, the passage is already provided in the wall and only needs to be opened. For example, the passage may be automatically opened by the tip of the infusion needle diving into the passage, which may then widen and open it. This reduces the risk that material is scraped off the wall by the edge of the opening of the infusion port as the infusion needle advances.

[0198] In a preferred embodiment, the passage has a widened entrance portion facing towards the housing, where it is normally open for the entry of at least one infusion needle into the passage during advancement thereof, thereby facilitating the insertion and further passage of the infusion needle into the passage.

[0199] In other embodiments, the tip of the infusion needle can be in the passage when the needle is in the retracted position, thus avoiding the need to feed the infusion needle properly into the passage when it is being advanced, however this is only an option for embodiments in which the tip end of the infusion needle is moved forward and backward during successive infusions, but not laterally.

[0200] Preferably, the passage 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 the opposite direction of the widthwise extension of the slit so as to open the slit, thereby opening a passage for the at least one infusion needle when 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 when the infusion needle is advanced.

[0201] Thus, an at least partially implantable system for injecting a substance into a patient's body comprises: - a housing for implantation within a patient's body, the housing having an outer wall with a penetration region; - 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 such that upon advancement of the at least one infusion needle, a tip of the at least one infusion needle penetrates said penetration area and a substance can be injected through said penetration area via the at least one infusion needle; Equipped with The through area 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 elastic forces generated by the elasticity of the elastic material, preferably the passage having a widened inlet portion which is normally open for the entry of the at least one infusion needle into the passage and / or which automatically opens for the passage of the at least one infusion needle when the infusion needle is advancing, the passage being preferably configured as a slit having a longitudinal extension and a lateral extension, the compressor may be arranged to act on the opposite side of the elastic material in the opposite direction of the lateral extension of the slit so as to open the passage for the at least one infusion needle when the infusion needle is advancing.

[0202] 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 is rounded or chamfered. In this way, the sharpness of the edge is reduced, thereby reducing the risk of material being scraped off by the edge of the opening of the injection port when the infusion needle is advanced. Preferably, the rounded or chamfered edge is provided at least on opposite sides of the injection port, and the imaginary connecting line between said opposite sides of the injection port runs along the forward and backward directions of the infusion needle. These are the areas of the injection port where scraping off of material by the outer edge of the injection port most occurs.

[0203] Thus, an at least partially implantable system for injecting a substance into a patient's body includes: - a housing for implantation within a patient's body, the housing having an outer wall with a penetration region; - 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 such that upon advancement of the at least one infusion needle, a tip of the at least one infusion needle penetrates said penetration area and a substance can be injected through said penetration area via the at least one infusion needle; Equipped with an injection port is provided on a side of at least one 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 opposing side surfaces of the injection port, and an imaginary connecting line between said opposing side surfaces of the injection port extends along the direction of movement of the injection needle.

[0204] [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 comprises: a first portion configured to be disposed on a first side of a 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 a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and connecting the first portion to the second side of the tissue portion. a connecting portion configured to connect to a second portion, where a first plane, a second plane, and a third plane are parallel to one another, and a third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, 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 plane, the second plane, and the third plane; and the connecting portion and the second portion configured to form a connecting interface between the connecting portion and the second portion, where the second portion extends along a first direction parallel to the second plane, the second portion has 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 disposed closer to the connecting interface with respect to the first direction.

[0205] 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 having a length between the first end and the second end, the second portion having an intermediate region and a distal region, the intermediate region defined by a connection interface between the connecting portion and the second portion, and the distal region extending from the connection interface between the connecting portion and the second portion to the second end.

[0206] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion towards the second end.

[0207] In some embodiments, the cross-sectional area along the length of the second portion decreases linearly from the end of the midregion to the second end.

[0208] In some embodiments, the cross-sectional area along the length of the second portion decreases gradually from the end of the midregion towards the second end.

[0209] In some embodiments, the distal region of the second portion is conical.

[0210] In some embodiments, the second portion has rotational symmetry along the first direction.

[0211] In some embodiments, the second surface of the second portion is substantially perpendicular to the central extension of the connecting portion.

[0212] In some embodiments, the second surface of the second portion is substantially parallel to the second plane.

[0213] 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 an underside surface facing away from the first portion configured to taper towards the second end.

[0214] 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.

[0215] In some embodiments, the cross-sectional area along the length of the second portion decreases continuously from the end of the midregion towards the first end.

[0216] In some embodiments, the cross-sectional area along the length of the second portion decreases linearly from the end of the midregion to the first end.

[0217] In some embodiments, the cross-sectional area along the length of the second portion decreases gradually from the end of the midregion towards the first end.

[0218] In some embodiments, the proximal region of the second portion is conical.

[0219] In some embodiments, the first end and the second end each comprise an ellipse point.

[0220] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0221] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0222] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0223] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0224] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0225] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0226] In some embodiments, the connection interface between the connection portion and the second portion is eccentric in a first direction relative to the second portion, but not eccentric in a second direction perpendicular to the first direction.

[0227] In some embodiments, the connection interface between the connection portion and the second portion is off-centered relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0228] In some embodiments, the second direction is parallel to a second plane.

[0229] In some embodiments, the proximal region and the distal region comprise a second surface configured to engage a second surface of a second side of the tissue portion.

[0230] In some embodiments, the second portion tapers from the first end to the second end.

[0231] In some embodiments, the second portion tapers from an intermediate region of the second portion to each of the first and second ends.

[0232] In some embodiments, the first portion has a maximum dimension in the range of 10-40 mm, such as in the range of 10-30 mm, for example in the range of 15-25 mm.

[0233] In some embodiments, the first portion has a diameter in the range of 10-40 mm, such as in the range of 10-30 mm, for example in the range of 15-25 mm.

[0234] In some embodiments the connecting portion has a maximum dimension in the third plane in the range of 2-20 mm, such as in the range of 2-15 mm, for example in the range of 5-10 mm.

[0235] In some embodiments, the second portion has a maximum dimension in the range 30-90mm, such as in the range 30-70mm, for example in the range 35-60mm.

[0236] 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.

[0237] In some embodiments, the connecting portion has one of an elliptical cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane.

[0238] In some embodiments, the distal region is configured to face downwardly in a standing patient.

[0239] 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.

[0240] 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.

[0241] 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.

[0242] 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.

[0243] 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.

[0244] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0245] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0246] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0247] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0248] In some embodiments, the second portion comprises a second wireless energy receiver.

[0249] In some embodiments, the first portion comprises a first energy storage unit.

[0250] In some embodiments, the second portion comprises a second energy storage unit.

[0251] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0252] In some embodiments, the solid state battery is a thionyl chloride battery.

[0253] 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 energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0254] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0255] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0256] In some embodiments, at least one of the first and second controllers is coupled to a wireless transceiver for wirelessly communicating with an external device.

[0257] 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.

[0258] In some embodiments, the second controller is coupled to a second wireless communication receiver for receiving wireless communications from the first portion.

[0259] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0260] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and to wirelessly transmit energy to a second wireless receiver in the second portion.

[0261] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0262] 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.

[0263] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0264] 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.

[0265] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0266] In some embodiments, the second portion forms at least a part of a manipulation device for manipulating the implantable body engaging portion.

[0267] In some embodiments, the second portion comprises at least one electric motor.

[0268] 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.

[0269] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0270] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0271] In some embodiments, the transmission comprises a gear system.

[0272] 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.

[0273] In some embodiments, the second portion comprises at least one hydraulic pump.

[0274] In some embodiments, the hydraulic pump comprises a pump that includes at least one compressible hydraulic reservoir.

[0275] 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 configured to be charged by at least one of the first and second energy storage units and to power the electric motor.

[0276] 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.

[0277] 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.

[0278] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit a force from the second portion to the implant engaging portion.

[0279] 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.

[0280] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0281] In some embodiments, the connecting portion comprises a conduit for transferring a fluid from the first portion to the second portion.

[0282] In some embodiments, the conduit is positioned to extend through a hollow portion of the connecting portion.

[0283] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of a patient.

[0284] In some embodiments, the walls of the first chamber are resilient to allow expansion of the first chamber.

[0285] In some embodiments, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuable implant element configured to apply a force to a body part of the patient, and a second hydraulic system in fluid communication with a second hydraulically actuable implant element configured to apply a force to the body part of the patient, wherein the first and second hydraulically actuable implant elements are independently adjustable from one another.

[0286] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0287] In some embodiments, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0288] In some embodiments, the implantable energized medical device further comprises a first pressure sensor configured to sense a pressure of the first hydraulic system and a second pressure sensor configured to sense a pressure of the second hydraulic system.

[0289] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0290] In some embodiments, the first, second and third planes are parallel to a primary plane of extension of the tissue.

[0291] In some embodiments, the fourth plane is parallel to the primary plane of stretch of the tissue.

[0292] 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 of 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 of the second side of the tissue portion, the 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 having a third cross-sectional area in a third plane and comprising 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 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 is configured to receive electromagnetic waves at a frequency above a frequency level and / or to transmit electromagnetic waves at a frequency below a frequency level, and the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level, the frequency level being 100 kHz.

[0293] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0294] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency above the frequency level to an external device.

[0295] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0296] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0297] 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.

[0298] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0299] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0300] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device above a frequency level, 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 below a frequency level.

[0301] In some embodiments, the second controller is coupled to a second wireless communication receiver for receiving wireless communications from the first portion below the frequency level.

[0302] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0303] In some embodiments, the outer casing forms the complete housing, and electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0304] In some embodiments, the second portion comprises an outer casing made of titanium.

[0305] In some embodiments, the outer casing forms the complete housing, and electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0306] A further aspect of the present disclosure relates to an implantable, energized medical device, which may be advantageously combined with the disclosed implantable drug delivery system, 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 of 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 of the second side of the tissue portion. a connecting portion configured to be positioned through a hole in the tissue portion extending between a first side and a second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, hereinafter the first plane, the second plane and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, and 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.

[0307] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0308] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0309] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to an external device.

[0310] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0311] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0312] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter below the frequency level and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion below the 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 the frequency level.

[0313] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0314] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0315] In some embodiments, the first controller is coupled to a first wireless communication receiver in the first portion for receiving wireless communications from an external device below a frequency level, and the first controller is coupled 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 a frequency level.

[0316] In some embodiments, the second controller is coupled to a second wireless communication receiver for receiving wireless communications from the first portion below the frequency level.

[0317] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0318] In some embodiments, the first portion comprises an outer casing made of titanium.

[0319] In some embodiments, the outer casing forms the complete housing, and electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0320] In some embodiments, the second portion comprises an outer casing made of titanium.

[0321] In some embodiments, the outer casing forms the complete housing, and electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0322] A further aspect of the present disclosure relates to an implantable, energized medical device, which may be advantageously combined with the disclosed implantable drug delivery system, 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 of 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 of the second side of the tissue portion. a connecting portion configured to be positioned through an opening in the tissue portion extending between the first portion and the second side, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, hereinafter the first plane, the second plane and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, to prevent the first portion, the second portion and the connecting portion from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane and the third plane, the first portion being made from a polymeric material and the second portion being composed of a casing made from titanium, the casing forming a complete housing.

[0323] In some embodiments, the casing of the second part forms a complete enclosure when the second part is coupled to the coupling part such that the entire outer surface of the second part is covered by the casing.

[0324] In some embodiments, the first portion comprises a casing made from a polymeric material.

[0325] In some embodiments, the casing of the first portion forms a complete enclosure such that the entire outer surface of the first portion is covered by the casing.

[0326] 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.

[0327] In some embodiments, the splice is disposed in the splice core such that it is sealed by the outer material of the splice.

[0328] In some embodiments, the coupling portion comprises a ceramic material.

[0329] In some embodiments, the connections are encapsulated in a ceramic material.

[0330] In some embodiments, the first portion comprises a first connecting portion configured to connect to a connecting portion of the connecting portion.

[0331] In some embodiments, the second portion comprises a second connecting portion configured to connect to the connecting portion of the connecting portion.

[0332] In some embodiments, the casing of the second part is hermetically sealed.

[0333] In some embodiments, the second connection is positioned such that the hermetic seal of the second portion remains intact.

[0334] In some embodiments, the casing of the first part is sealed.

[0335] 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 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 of 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 of 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 of the first side of the tissue portion; 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 the lengthwise direction.

[0336] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0337] In some embodiments, the connecting portion tapers along the central extension axis in a direction from the first portion to the second portion.

[0338] 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.

[0339] In some embodiments, the second portion is longitudinally tapered.

[0340] In some embodiments, the connecting portion has a circular or elliptical cross-section that decreases in diameter along its length.

[0341] In some embodiments, the length extends from the interface between the connecting portion and the second portion toward an end of the second portion.

[0342] In some embodiments, the length extends in a direction substantially perpendicular to the central elongate axis. [Brief description of the drawings]

[0343] 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 overall system of the present disclosure implanted in a patient's body according to a first variant. [Diagram 2] FIG. 2 shows the entire system of the present disclosure implanted in a patient's body according to a second variant. [Diagram 3] FIG. 3 is a first general concept showing how the puncture area can be punctured by the infusion needle at different puncture sites. [Figure 4] FIG. 4 is a second general concept showing how a puncture site can be punctured by an infusion needle at different puncture sites. [Diagram 5] FIG. 5 is a front view and a rear view of the drive unit according to the first embodiment. [Figure 6] FIG. 6 is a front view and a rear view of the drive unit according to the first embodiment. [Figure 7] FIG. 7 shows a needle cooperating part of a drive device according to a first embodiment to which an injection needle is attached. [Figure 8] 8 is a perspective view of the needle cooperating member and base of FIG. [Figure 9] FIG. 9 is a front view of the drive unit according to the second embodiment. [Figure 10] FIG. 10 is a rear view of the drive unit according to the second embodiment. [Figure 11] FIG. 11 is a front view of the drive unit according to the third embodiment. [Figure 12] FIG. 12 is a rear view of the drive unit according to the 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 drive 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] FIG. 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] FIG. 20 is a top 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 a system overview of an external device that is made up of a housing and a display device that wirelessly communicates with an implantable medical device. [Diagram 23] FIG. 23 shows an implant having an implant surface and a coating disposed on the surface. [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 illustrates one embodiment of an implantable energized medical device. [Figure 28] FIG. 28 illustrates one embodiment of an implantable energized medical device. [Figure 29A] FIG. 29A shows the first and connecting portions of the medical device of FIGS. [Figure 29B] FIG. 29B shows the first portion and the 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. 29 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 modification 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 modification of the elements of the connecting portion of FIGS. 29A to 29C. [Diagram 33] FIG. 33 shows a kit for assembling the medical device of FIGS. [Diagram 34] FIG. 34 illustrates a further embodiment of an implantable energized medical device. [Diagram 35] FIG. 35 shows a typical example of an implantable energized medical device. [Diagram 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 illustrates a different relative arrangement of the first and second components 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. [Fig. 39H] FIG. 39H illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39I] FIG. 39I illustrates a different relative arrangement of the first and second parts of the medical device of FIG. [Figure 39J] FIG. 39J illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39K] FIG. 39K illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39M] FIG. 39M illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39N] FIG. 39N illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39P] FIG. 39P illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 39Q] FIG. 39Q illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Diagram 40] FIG. 40 shows a third variant of the general embodiment of the medical device of FIG. [Diagram 41] FIG. 41 shows a third variant of the general embodiment of the medical device of FIG. [Diagram 42] FIG. 42 shows the medical instrument of FIG. 35 with its first and second portions at different rotational displacements relative to one another. [Diagram 43] FIG. 43 shows the medical instrument of FIG. 35 with its first and second portions at different rotational displacements relative to one another. [Figure 44A] FIG. 44A illustrates a procedure for inserting the medical device of FIGS. [Figure 44B] FIG. 44B illustrates a procedure for inserting the medical device of FIGS. [Figure 44C] FIG. 44C illustrates a procedure for inserting the medical device of FIGS. [Diagram 45] FIG. 45 illustrates a further embodiment of an implantable energized medical device. [Figure 46A] FIG. 46A shows a gear arrangement and magnetic coupling for connecting an implantable, energized medical device to an implant. [Figure 46B] FIG. 46B shows a gear arrangement and magnetic coupling for connecting an implantable, energized medical device to an implant. [Figure 47A] FIG. 47A is a right side top perspective view of one embodiment of an implantable energized medical device for providing power to an implantable medical device. [Figure 47B] FIG. 47B shows a longitudinal cross-section of the implantable medical device taken along line AA in FIG. 47A. [Figure 47C] FIG. 47C shows a longitudinal cross-section of the implantable medical device taken along line AA of FIG. 47A. [Figure 48] FIG. 48 is a cross-sectional plan 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 view of an embodiment of an implantable energized medical device for providing power to an implantable medical device. [Figure 50] FIG. 50 is a cross-sectional plan view of an embodiment of an implantable energized medical device for providing power to an implantable medical device. [Figure 51A] FIG. 51A is a right side top perspective view of one embodiment of an implantable energized medical device for providing power to an implantable medical device. [Figure 51B] FIG. 51B shows a longitudinal cross-section of the implantable medical device taken along line AA in FIG. 51A. [Figure 51C] FIG. 51C shows a longitudinal cross-section of the implantable medical device taken along line AA of FIG. 51A. [Figure 52] FIG. 52 shows diagrammatically a variation of the overall system according to the first general embodiment of FIG. [Figure 53] FIG. 53 illustrates the principle of injecting a substance using an angled injection needle. [Figure 54A]FIG. 54A is a top view showing the front of the infusion needle with the injection port located near the tip of the infusion needle. [Figure 54B] FIG. 54B is a cross-sectional side view showing the front of the infusion needle with the infusion port located near the tip of the infusion needle. [Figure 55] FIG. 55 shows a schematic of the penetration area of ​​the system with the infusion needles located within each tube. [Figure 56] FIG. 56 shows a schematic of the penetration area of ​​the system having a preconfigured passageway with a widened entrance for the infusion needle to enter. [Figure 57] FIG. 57 shows a schematic of the penetration area of ​​the system having preconfigured passages through which the infusion needles extend at their respective tips. [Figure 58] FIG. 58 shows a schematic of the penetration area of ​​the system with width-wise passages and a pre-configured compressor for opening these passages. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0344] [Detailed explanation] Hereinafter, a detailed description of the embodiments of the present invention will be given 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. Thus, 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 numbers have the same functions, and therefore features of one embodiment can be exchanged with features of other embodiments having the same reference numbers unless there is a clear contradiction. Therefore, the descriptions of features having the same reference numbers should be considered as complementary to each other in explaining the basic ideas of the features, thereby showing the versatility of the features.

[0345] [System Wide] The overall system of the present disclosure will now be outlined in relation to FIG. 1, which shows a first variant of the overall system. The overall structure corresponds to that disclosed in FIG. 1 of WO2010 / 040548A1. In particular shown in this variant is a housing 12 with a single infusion needle 11 and a drive unit D. The drive unit D indicates diagrammatically by means of arrows that the needle or needles 11 can be moved in different directions. The housing 12 is provided with a self-sealing penetration area 14 arranged adjacent to the patient's blood vessel 7, here in the form of a corpus cavernosum, but which may be other types of blood vessels, in particular blood vessels such as veins or arteries. The infusion needle has a tubular body with a closed tip and may be provided with a delivery outlet port arranged laterally for delivering the drug. Thus, the needle does not cut any material, but merely splits it during penetration. Thus, when the needle penetrates a material such as fibrosis and / or the self-sealing penetration area 14 arranged in the wall of the housing, no material enters and blocks the drug delivery passage.

[0346] A motor M in the housing 12 is accommodated in 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 constituting the implantable part of the control system, which further comprises an external data processing unit C1 capable of transmitting commands and any kind of other data to the control unit C2. For example, the external data processing unit C1 can be used to start an injection cycle from outside the patient's body, this is done wirelessly as indicated by the arrow 23. The implanted control unit C2 not only controls the motor M in the housing 12, but also the energy supply from the accumulator A to the motor M in the housing 12.

[0347] The external data processing device C1 may also be used to program the embedded control unit C2, and a data transfer port for transferring data between the external data processing device C1 and the embedded control unit C2 may be adapted to transfer data in both directions.

[0348] 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 drug level within the corpus cavernosum, flow rate through the corpus cavernosum, pressure within the corpus cavernosum, etc. Other feedback sensors may be provided at different locations to sense process parameters of the system, such as electrical parameters, distention, distance, etc.

[0349] The conduit 19 connecting the needle 11 and 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.

[0350] In this variant of the overall system, the reservoir consists of a first compartment R1, in which, for example, physiological saline is contained, and a second compartment R2, in which, for example, a powdered or lyophilized drug is contained. A pump P, driven by a second motor M2, is arranged to pump the infusion fluid from the reservoir R1 to the infusion needle 11. The infusion fluid pumped by the pump P passes through a mixing chamber 26 into which the drug is released in a timed manner from the reservoir R2. The motor M2 or a separate motor may also cause the release of the drug from the second reservoir R2. The motor M2 is also controlled by the control unit C2. The infusion fluid pumped from the relatively large first reservoir R1 through the mixing chamber 26 thus mixes with the drug released from the second reservoir R2, while reaching the infusion needle 11, which has penetrated the self-sealing piercing area 14 of the housing 12, and flows into the corpus cavernosum 7.

[0351] 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.

[0352] The entire system may consist of one of many different reservoir types, but a specific reservoir type will be described here. The volume of the reservoir R1 is divided into two sections by a membrane 31. One is filled with gas and the other with infusion fluid (saline). An injection port 32 allows the reservoir R1 to be refilled with infusion fluid using a refill needle. When the reservoir R1 is full, the gas section is at normal or overpressurized pressure. As the pump P draws fluid from the 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 the pump P into the reservoir R1.

[0353] There are various ways of supplying energy to the motors M and M2. In the illustrated variant, energy is supplied from outside the patient's body for direct use by the motors and / or to charge an accumulator A, which may take the form of a rechargeable battery and / or a capacitor. An external primary energy source E transmits energy in a first form 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 the accumulator A, which supplies secondary energy to the motor M on demand.

[0354] 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 a particular type of wave signal of the primary energy source E.

[0355] 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.

[0356] The energy signal may also be used to transmit signals from the external data processing device C1 by suitable modulation of the energy signal, whether the energy is transmitted wirelessly or by wire, the energy signal thereby serving as a carrier signal for digital or analog control signals. More specifically, the control signals may be frequency-modulated, phase-modulated and / or amplitude-modulated signals.

[0357] Figure 2 shows a second variant of the overall system, which differs essentially from the system of figure 1 only in the complete omission of the motor M in the housing 12. This is achieved by a cable 33 which replaces the wire 24 of the system shown in figure 1.

[0358] [General concept] Figures 3 and 4 show two different general concepts of how the puncture area 14 can be punctured by the infusion needle 11 at different puncture sites. According to the first concept of Figure 3, the infusion needle 11 is accommodated in a housing 12 and is mounted on 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 transversely to the puncture site from one puncture site to the next. For this purpose, the needle cooperating member 13 is mounted along a cross guide 15 along which the needle cooperating member 13 is movable in the displacement direction. The second direction corresponds to the advance / retraction direction of the infusion needle 11, i.e. the direction in which the infusion needle 11 is moved to penetrate the penetration area 14 each time an infusion cycle is performed.

[0359] The second concept as shown in FIG. 4 differs from the first concept in that instead of a single laterally movable infusion needle, several infusion needles 11 are arranged side by side along the penetration area 14, of which only two exemplary infusion needles 11 are shown in FIG. 4. In this concept, the infusion needles 11 are not fixedly attached to the needle cooperating member 13. Instead, the needle cooperating member 13 consists of a positioning part 13A and a needle driving part 13B. The positioning part 13A is movable in the displacement direction along the cross guide 15 as described above. However, instead of displacing the infusion needles 11 laterally, only the needle driving part 13B is moved in the displacement direction from one infusion needle 11 to the next infusion needle 11. Once the needle driving part 13B has been moved to the desired position adjacent to one of the infusion needles 11, it is advanced by the second actuator 17, urging the infusion needle 11 to penetrate the penetration area 14. The respective infusion needle 11 can then be retracted by the force of the counteracting spring element or by the needle drive 13B, which at the end of the process needs to be decoupled from the respective infusion needle 11 in order to displace it further laterally to the next infusion needle 11.

[0360] In the following, the drive in the housing 12 is described with reference to three exemplary embodiments, where the first and second actuators 16, 17 are constituted by cables. In one embodiment, a single cable is used to both advance and / or retract the infusion needle 11 as well as to laterally displace it. The present disclosure provides different aspects, which may be described with respect to one or two of the three embodiments, but which may also be realized in one or both of the other embodiments as well.

[0361] [First embodiment] A drive unit 100 according to a first embodiment is shown in front and rear views in Figures 5 and 6, respectively. The drive unit 100 can be mounted in a housing 12 shown in Figures 3 and 4. The drive unit 100 comprises a base 101, two parallel linear bearings 102 protruding from opposite ends of the base 101, a translation frame 103 slidably movable along the two linear bearings 102 towards and away from the base 101, and two return springs 104 in the form of coil springs arranged on one of each of the two linear bearings 102. A needle cooperating member 113, along which the needle 11 is fixedly attached, is mounted on a cross guide 115 movable in a (lateral) displacement direction along it. The cross guide 115 is fixedly attached at its opposite end to the translation frame 103 such that movement of the translation frame 103 along the linear bearings 102 towards and away from the base 101 advances and retracts the infusion needle 11 in forward and retract directions, respectively. As the infusion needle 11 advances, it penetrates a septum 116 located adjacent the penetration area 14 in the housing 12 described above in relation to Figures 3 and 4. Alternatively, the septum may be located in a wall of the housing to form the penetration area 14.

[0362] The base 101 is stationary with respect to the housing 12, e.g., glued to the housing, press-fitted into the housing, or mechanically held within the housing, and therefore within the context of the present disclosure elements fixed to the base 101 and elements fixed to the housing 12 are understood to be synonymous. This applies to all embodiments.

[0363] The lateral movement of the needle cooperating member 113, to which the infusion needle 11 is attached, in the opposing first and second displacement directions is realized by a displacement cable 120. The displacement cable 120 loops around a first wheel 121 and a second wheel 122, which are respectively mounted on the first and second linear bearings 102, as shown in FIG. 6. The opposing ends 124 of the displacement cable 120 are crimped and fixed in pockets of the needle cooperating member 113, as shown in FIG. 5. Thus, by moving the displacement cable 120 forwards or backwards, the needle cooperating member 113 and the infusion needle 11 are moved in the respective lateral displacement directions. The displacement cable 120 winds multiple times around each of the first and second wheels 121, 122 to increase friction between the displacement cable 120 and the first and second wheels 121, 122, thereby avoiding slippage of the displacement cable 120. The tension element 123 is fixedly held on the translation frame 103 to generate tension in the displacement cable 120 transversely to the longitudinal axis of the displacement cable 120 so as to reduce slack in the displacement cable 120. In the illustrated embodiment, the tension element 123 is a leaf spring arranged in a pocket on the rear side of the translation frame 103 to maintain the cable tension in the loop. It is to be noted that instead of being a cable, the displacement cable 120 may also be realized as a displacement belt, in particular as a toothed displacement belt wound around the first and second toothed wheels 121, 122.

[0364] To move the displacement cable 120, a drive cable 125 extends into the housing 12 from a remote motor, which may be an electric motor, through a wall of the housing 12 (not shown). The drive cable 125 may be looped around the first wheel 121 or the second wheel 122 to drive one wheel or the other. However, in the preferred embodiment shown in Figures 5 and 6, the drive cable 125 is wrapped around a third wheel 126 mounted on a linear bearing 102, here the linear bearing 102 on which the first wheel 121 is mounted. The corresponding linear bearing 102 is thus rotatably mounted on both the base 101 and the translation frame 103, and rotation of the wheel 126 by the drive cable 125 rotates the linear bearing 102 and the first wheel 121 fixedly mounted thereon, thereby causing movement of the displacement cable 120 as described above.

[0365] In a not shown embodiment, the displacement cable 120 may be replaced by the drive cable 125 in that the drive cable 125 may be fixedly connected to the needle cooperating member 113. In this case, the drive cable 125 enters the housing on one side relative to the translation frame 103, loops around the second wheel 122 on the respective other side of the translation frame 103, preferably multiple times, and exits the housing again, for example on the first side relative to the translation frame 103. In this case, the first wheel 121 may be unnecessary. As a further alternative, the drive cable 125, which is fixedly connected to the needle cooperating member 113, may enter the housing on one side and exit the housing on the other side, in which case both the first and second wheels 121, 122 may be omitted.

[0366] In all embodiments in which the displacement cable 120 and / or drive cable 125 are wound around the corresponding wheels 121, 122 and / or 126, they may instead be wound on or off the corresponding wheels, in which case the cables may have one end attached to the respective wheels, as will be further described below in connection with the second embodiment.

[0367] For the advancement and retraction of the infusion needle 11 in an advancement and retraction direction, preferably perpendicular to the lateral displacement direction, a separate advancement and retraction cable 130 is provided. Similar to the drive cable 125, the advancement cable 130 is connected to a remotely arranged motor, i.e. a second motor, which may be an electric motor, from which the advancement cable 130 extends through the wall of the housing 12 into the housing 12. The basic principle is to connect the advancement cable 130 to the translation frame 103 in such a way that by pulling the advancement cable 130, the translation frame 103 moves along the linear bearings 102 towards the base 101. According to the least complicated construction, one end of the advancement cable 130 is fixed to the translation frame 103, from which the advancement cable 130 extends downwards towards the base 101 and is further guided from the housing 12 towards the remote second motor, either directly or via a guide wheel.

[0368] However, because the pulling force of the advancement cable 130 required to insert and advance the infusion needle 11 through the septum 116 can be relatively large, the preferred embodiment shown in Figures 5 and 6 includes a block-and-tackle set-up of which the advancement cable 130 forms a part. This set-up reduces the amount of power required to advance the infusion needle 11 through the penetration area of ​​the septum 116 and the wall of the housing 12. Thus, the motor for driving the advancement cable 130 may be relatively small.

[0369] More specifically, as shown in the embodiment of Figs. 5 and 6, one or preferably two pulleys are fixed to the translation frame 103 so as to move therewith, and another one or preferably two second pulleys 133 are fixed to the base 101, i.e. the housing 12 so as to be stationary, as shown in the embodiment of Figs. 5 and 6. The end 131 of the advancement cable 130 is crimped to the base 101 and grounded. Alternatively, it may be fixed to the translation frame 103, in which case one of the first pulleys 132 can be omitted (thereby reducing the block-and-tackle effect) or a further second pulley 133 can be provided to the base 101 (thereby further increasing the block-and-tackle effect). In the embodiment shown, the advancement cable 130 is wound twice around one of the two second pulleys 133, so that this pulley is realized as a double pulley.

[0370] FIG. 7 shows the needle cooperating part 113 to which the infusion needle 11 is attached. More specifically, the infusion needle 11 is curved and the curved part of the infusion needle 11 is placed in a corresponding curved recess 114 of the needle cooperating part 113. This makes it easier to attach the infusion needle 11 in the correct position on the needle cooperating part 113 when assembling the system. The curved recess 114 provides a counter force to the force acting on the infusion needle 11 when it is advanced to penetrate with its front end through the bulkhead 116 and further through the penetration area 14 of the wall of the housing 12. Preferably, the infusion needle 11 is welded or potted to the needle cooperating part 113 in the area of ​​the recess 114 so as to hold the infusion needle 11 securely in place. The infusion port 11A at the front end of the infusion needle 11 is designed as a side port arranged on the side of the tubular needle body 11B. The opposite end of the injection needle 11 is provided with a tubing connection 18 for connecting a drug supply line, such as the conduit 19 shown in Figure 1. Finally, a needle stiffening tube 20 is disposed around the injection needle 11 to stiffen the tubular needle body 11B to minimize deflection as the injection needle 11 penetrates the septum 116 and penetration region 14 of the housing 12.

[0371] 8 is a perspective view of the needle cooperating part 113 with the infusion needle 11 and the base 101. As can be seen, the base 101 is provided with a window 105 for the passage of the tube 19 through the infusion needle 11. The base 101 provides sufficient space for the tube 19 to be wound in a loop within the housing 12 so that the tube 19 can cover the full range of motion required for the lateral displacement and / or advancement and retraction of the needle 11.

[0372] The overall dimensions of the actuator 100 shown in this first embodiment can be 40 mm high, 30 mm wide, and 6 mm deep, or less. This provides enough space for 15 injection sites, assuming a 1 mm space between the centers of adjacent injection sites. Increasing the width of the actuator increases the number of injection sites one-to-one, i.e., each additional millimeter increases the number of injection sites by one.

[0373] [Second embodiment] The front and rear views of a second embodiment of the drive unit 200 are shown in Fig. 9 and Fig. 10, respectively. Its structure is largely the same as the first embodiment described above. The drive unit 200 thus consists of a base 201, two parallel linear bearings 202 extending from opposite ends of the base 201, a translation frame 203 slidably mounted on the two linear bearings 202 so as to be movable along the linear bearings 202 towards and away from the base 201, and two return springs 204 in the form of coil springs mounted respectively around the linear bearings 202. A cross guide 215 is fixedly mounted at its opposite ends on the translation frame 203, and a needle-like cooperating member 230 is slidable along the cross guide 215 in opposite lateral displacement directions, which displacement directions are different from the extension direction of the linear bearings 202 and are in particular vertical. Thus, by moving the translation frame 203 along the linear bearings 202 towards and away from the base 201, the needle cooperating member 230, together with the infusion needle 11 which is fixedly attached to the needle cooperating member 213, is advanced and retracted in opposite forward and retraction directions.

[0374] The second embodiment differs essentially from the first embodiment in that a single advancement and retraction cable 240 is provided and is arranged to both advance the infusion needle 11 in the advancement direction and displace it in the displacement direction. A first actuator, such as a first electric motor (not shown), may be attached to a first end of the advancement and retraction cable 240, and a second actuator, such as a second electric motor (not shown), may be attached to a second end of the advancement and retraction cable 240. The first and second motors are preferably located remote from the housing, such that the first and second ends of the advancement and displacement cables 240 are guided through the wall of the housing 12.

[0375] The advance / retract cable 240 is guided over two first pulleys 232 fixed to the base 201 so as to be stationary, and two second pulleys 233 fixed to the advance / retract frame 203 so as to move in the advance / retract direction together with the advance / retract frame 203. More specifically, the advance / retract cable 240 is guided over one of the two first pulleys 232 fixed to the base, further to the translation frame 203, and further over the other of the two first pulleys 232 fixed to the housing, so that when the opposing ends of the advance / retract cable 240 are pulled the same distance in the opposing first and second pulling directions, the translation frame is pulled along the linear bearings 202 in a direction towards the two first pulleys 232, i.e. in the forward direction of the infusion needle 11. The return spring 204 is positioned to bias the advance / retract frame 203 towards the rest position such that when the tension on the advance / retract cable 240 is reduced, the return spring 204 causes automatic movement of the advance / retract frame 203 back to its rest position shown in Figures 9 and 10.

[0376] Furthermore, the forward / backward displacement cable 240 is not directly attached to the translation frame 203, but rather is attached to the needle cooperating member 213 which is movable along a cross guide 215 attached to the translation frame 203 and is further guided over two opposing second pulleys 233 which are fixedly connected to the needle cooperating member 213, so that pulling the forward / backward displacement cable 240 in one or the other direction, for example pulling only one end of the forward / backward displacement cable 240, causes the needle cooperating member 113 to move along the cross guide 215 and thereby displaces the infusion needle 11 laterally in the displacement direction. For example pulling only one end of the forward / backward displacement cable 240 causes the needle cooperating member 113 to move along the cross guide 215 and thereby displaces the infusion needle 11 laterally in the displacement direction. Thus, if a lateral displacement of the infusion needle 11 is desired while the translation frame 203 is in its rest position, only one end of the forward end displacement cable 240 should be pulled, since pulling both ends of the forward end displacement cable 240 simultaneously would also advance the infusion needle 11 towards the bulkhead 216. Similarly, if advancement of the infusion needle 11 is desired, both ends of the forward displacement cable 240 should be pulled over the same distance to avoid lateral movement of the infusion needle 11 during advancement. It is important to ensure that the return spring 204 is strong enough to prevent movement of the translation frame 203 along the linear bearing 202 when the forward / retract cable 240 is tensioned to cause a lateral displacement of the needle cooperating member 213.

[0377] 9 and 10, the advance / retract cable 240 is made up of two separate cable portions, each of which has one end connected to the needle cooperating member 213. Specifically, each end is crimped and held in a crimp pocket 214 formed in the needle cooperating member 213.

[0378] Otherwise, the second embodiment corresponds to the first embodiment. For example, when the needle cooperating member 213 is advanced, the injection needle 11 penetrates the septum 216 and further into the patient, so that the drug can be delivered through the injection port 11a. Furthermore, the injection needle 11 is a curved needle fixedly attached to the needle cooperating member 213, as described in connection with the first embodiment. Again, a conduit for applying the drug to be injected may be attached to the tube connection 18 at the end of the injection needle 11 facing the injection port 11A.

[0379] For a drive unit 200 having dimensions of 41 mm height, 32 mm width, and 7 mm depth, the drive unit 200 can be designed such that there is enough space for 18 injection sites with a center-to-center distance of 1 mm between adjacent injection sites. By reducing the number of injection sites from 18 to 16, the width can be further reduced to 30 mm.

[0380] [Third embodiment] 11 and 12 respectively show a front view and a rear view of a third embodiment of the drive unit 700. The third embodiment differs from the first and second embodiments mainly in that instead of a single infusion needle, an array 705 of infusion needles 11 is provided. Thus, instead of moving the infusion needle laterally in the displacement direction, only the needle cooperating member 713 is moved laterally in the displacement direction to act on one infusion needle 11 of the array 705 of infusion needles 11, thereby advancing the infusion needle 11.

[0381] As in the first and second embodiments, the drive unit 700 of the third embodiment comprises a base 701, two linear bearings 702 arranged in parallel and extending from opposite ends of the base 701, a translation frame 703 slidably moving along the linear bearings 702 towards and away from the base 701, and two return springs 702 respectively arranged around the linear bearings 702 to bias the translation frame 703 to a rest position away from the base 701. Furthermore, as in the previous embodiments, a shaft-shaped cross guide 715 is fixedly connected at its opposite ends to the translation frame 703. A needle cooperating member 713 is attached to the cross guide 715 so as to be slidable along the cross guide 715 in opposite displacement directions.

[0382] In this third embodiment, the needle cooperating member 713 is composed of two parts separable from each other, namely the needle driving part 713B, which is a part slidably mounted on the cross guide 715, and the positioning part 713A, which is slidably mounted on the secondary cross guide member 715A. Thus, the cross guide 715 to which the needle driving part 713B of the needle cooperating member 713 is movably mounted constitutes the primary cross guide, and the secondary cross guide member 715A to which the positioning part 713A of the needle cooperating member 713 is movably mounted constitutes the secondary cross guide. As will be explained in more detail below, when the translation frame 703 is in its rest position shown in Figures 11 and 12, the positioning part 713A and the needle driving part 713B are engaged with each other such that movement of the positioning part 713A along the secondary cross guide member 715A causes a corresponding movement of the needle driving part 713B along the (primary) cross guide 715.

[0383] This is further illustrated in Fig. 13. As can be seen, the protrusion 707 of the positioning part 713A extends into a corresponding recess 708 of the needle driver 713B. Of course, the protrusion 707 could be arranged in the recess 708 of the needle driver 713B and the positioning part 713A as well, or any other engagement structure could be provided that holds the positioning part 713A and the needle driver 713B together in the lateral displacement direction, but allows disengagement of the positioning part 713A and the needle driver 713B in a direction different from the displacement direction, preferably perpendicular to it, i.e. in the advancement direction of the infusion needle.

[0384] A crimped end 724 of the displacement cable 720 is attached to the positioning part 713A and is guided on wheels 721 towards an actuator, which may be an electric motor outside the housing 12. Pulling the displacement cable 720 in a first displacement direction, to the left in Fig. 13, causes the positioning part 713A to slide in the first displacement direction along the secondary cross guide member 715A, which engages with the needle drive part 713B, so that the needle drive part 713B is also moved in the same displacement direction along the (primary) cross guide 715A.

[0385] A constant force spring 709 is also attached to the positioning part 713A so as to generate a force counteracting the pulling force acting on the displacement cable 720. This serves to hold the positioning part 713A in a relative position to the secondary cross-guide member 715A and thus the needle drive part 713B in a relative position to the (primary) cross-guide 715. By designing the spring 709 as a constant force tension spring, the tension force required to move the needle cooperating part 713 along the cross-guide 715, and therefore the power provided by the associated motor, is constant, regardless of the relative position of the needle cooperating part 713 to the cross-guide 715. In the illustrated embodiment, the constant force tension spring 709 consists of a metal band that winds on itself when not tensioned. One end of the metal band is attached to a reel and the other end is connected to the positioning part 713A of the needle cooperating part 713. The tension spring 709 exerts a constant reaction force when the needle cooperating member 713 is pulled step by step along the cross guide 715 with the aid of the displacement cable 720. When the tension of the displacement cable 720 is released, the tension spring automatically rewinds onto the reel, thereby pulling the needle cooperating member 713 back to its starting position. The tension force exerted by the tension spring 709 is between 0.5N and 2N, preferably between 0.8N and 1.2N, more preferably about 1N.

[0386] The accurate positioning of the needle cooperating member 713 is supported by first and second alignment structures which engage with each other to define different rest positions of the needle cooperating member 713. One of the alignment structures is stationary with respect to the displacement direction, while the other alignment structure is movable with the needle cooperating member 713. For example, the first alignment structure may be a leaf spring and the second alignment structure may consist of a number of stationary detents or protrusions arranged to cooperate with the leaf spring. This concept can be provided in the first and second embodiments described as well.

[0387] As shown in Figure 13, in the third embodiment, the first alignment structure is a leaf spring 711 attached to the needle drive 713B of the needle cooperating member 713, and the second alignment structure consists of a number of detents or protrusions 710 arranged on the translation frame 703 to cooperate with the leaf spring 711. This is shown in more detail in Figure 14. Thus, when the needle cooperating member 713 is moved relative to the cross guide 715 in the displacement direction from one position to the next, the free end of the leaf spring 711 is urged backwards to disengage from the detents or protrusions 710 and then snaps forward again to re-engage with an adjacent one of the detents or protrusions. As can also be seen in FIG. 14, the needle drive parts 713B of the needle cooperating members 713 have protrusions 712 arranged closely adjacent to the infusion needles 11, i.e. slightly above them, so that when the translation frame 703 moves downwards in the forward direction, the protrusions 712 push each one of the infusion needles 11 downwards in the forward direction.

[0388] The downward movement of the needle drive 713B in the forward direction is realized in the same way as described above in connection with the first embodiment. Thus, similar to Fig. 6 for the first embodiment, Fig. 11 for the third embodiment shows a block-and-tackle set-up consisting of an advancement cable 730 whose free end 731 is fixed to the base 701 and guided along two first pulleys 732 attached to the translation frame 703 and two second pulleys 733 fixedly attached to the base 701 and thus to the housing 12. Thus, when the needle cooperating member 713 is moved by the displacement cable 720 into a suitable position relative to one of the infusion needles 11 of the needle array 705, the advancement cable 730 can be pulled such that the needle drive 713B of the needle cooperating member 713 moves downward together with the translation frame 703, thereby, on the one hand, disengaging from the positioning part 713A of the needle cooperating member 713 and, on the other hand, urging each one of the infusion needles 11 of the needle array 705 downward in the forward direction.

[0389] This is further illustrated in Fig. 15, which shows only some relevant parts of the drive unit 700. Thus, the needle driver 713B is shown in a disengaged position having already pushed one infusion needle 11 of the needle array 705 through the penetration area 14 of the housing 12 (not shown) into the patient's vein 2. When tension on the advancement cable 730 is released, the advanced infusion needle 11 is automatically retracted to its rest position by the return spring 704. More specifically, as shown in Fig. 11, the crossbar 703A of the translation frame 703 is arranged below the lateral extension 11C of the infusion needle 11, such that when the translation frame 713 is returned to its rest position, the crossbar 703A comes into contact with the lateral extension 11C and moves the infusion needle 11 upwards.

[0390] 15 further illustrates a method of delivering a drug to a patient through an injection needle 11. This concept utilizes an injection needle 11 having a delivery port 11D located on the side of the tubular needle body 11B away from the tip of the injection needle 11. The substance to be injected is thus delivered sideways into the tubular needle body 11B. Inside the tubular needle body 11B, as described above, a needle lumen (not shown) is formed that communicates between the delivery port 11D and the injection port 11A, which is also realized as a side port.

[0391] As shown in FIG. 15, the septum 716 consists of an upper septum 716A and a lower septum 716B, and an internal reservoir 717 between the upper septum 716A and the lower septum 716B. The injection needle 11 extends through the upper septum 716A, the internal reservoir 717 and the lower septum 716B. In their retracted positions, the supply port 11D is protected by the upper septum 716A and the injection port 11A is protected by the lower septum 716B. In their forward positions, the supply port 11D is located inside the internal reservoir 717 and the injection port 11A is located outside the housing 12, thereby allowing the substance to be injected to flow from the internal reservoir 717 through the supply port 11D and the lumen of the tubular needle body 11B towards the injection port 11A and through the injection port 11A into the patient's body. The spacing between the delivery port 11D and the injection port 11A is selected such that the injection port 11A is fully inserted into the patient before the delivery port 11D accesses the internal reservoir 717.

[0392] A supply lumen 750 for supplying an infusion substance to the internal reservoir 717 is disposed to run alongside the lumen of the linear bearing 702. The lumen connects directly to the internal reservoir 717, as shown in FIG.

[0393] The overall dimensions of the driver 700 are preferably no greater than 46 mm in height, 33 mm in width, and 8.5 mm in depth, allowing for approximately 14 discrete injection sites in the needle array 705 spaced 1.5 mm on center.

[0394] [Communication (controller, encryption / decryption, authentication / verification)] Communications between the external devices or between the external devices and the implant may be encrypted. Any suitable type of encryption may be employed, such as symmetric or asymmetric encryption. The encryption may be single-key encryption or multi-key encryption. In multi-key encryption, multiple keys are required to decrypt the encrypted data. The multiple keys may be referred to as a first key, a second key, a third key, etc., or a first part of a key, a second part of a key, a third part of a key, etc. The multiple keys are combined in any suitable manner (depending on the encryption scheme and use case) to derive a combined key that can be used for decryption. In some cases, deriving a combined key means using each key one by one to decrypt the data, resulting in the decrypted data when the final key is used.

[0395] Also, multiple keys may be combined to result in one "master key" that decrypts the data. In other words, this is a form of secret sharing, where the secret is split into parts and each participant (external device, internal device) is given their own part. A minimum number of parts (keys) are needed to reconstruct (decrypt) the original message. In threshold methods, this number is less than the total number of parts (e.g., the implant's key and the keys of one of the two external devices are needed to decrypt the data). In other embodiments, all the keys are needed to reconstruct the original secret to achieve a combined key that may decrypt the data.

[0396] It should be noted that the generator of the key for decryption does not necessarily ultimately send the key to another device for use on that device - in some cases the generator of the key simply facilitates the encryption / decryption and performs operations on behalf of other devices / users.

[0397] The verification unit may constitute any suitable means for verifying or authenticating the use (i.e., user authentication) of a unit (such as an external device) constituting or connected to the verification unit. For example, the verification unit may constitute or be connected to an interface (UI, GUI) for receiving authentication input from a user. The verification unit may include a communication interface for receiving authentication data from a device (apart from the external device) connected to the device constituting the verification unit. The authentication input / data may consist of biometric data based on any suitable technology, such as a code, a key, a fingerprint, palm vein structure, image recognition, face recognition, iris recognition, retina scan, hand geometry, genomic comparison, etc. The verification / authentication may be provided using a third party application installed on or in association with the verification unit.

[0398] The verification unit can be used as part of a two-part authentication procedure, the other part consisting of, for example, conductive communication authentication, sensation authentication, or parameter authentication.

[0399] The verification unit may consist of a card reader to read smart cards. Smart cards are typically secure microcontrollers used to generate, store, and manipulate cryptographic keys. Smart card authentication involves providing a user with a smart card device for authentication. The user connects the smart card to the verification unit. Software on the verification unit interacts with the key material and other secrets stored on the smart card to authenticate the user. To activate the smart card, the user must unlock the smart card with a user PIN. Smart cards are considered a very strong form of authentication because the cryptographic keys and other secrets stored on the card are very well protected, both physically and logically, making them difficult to steal.

[0400] The verification unit can consist of a personal e-ID, comparable to a passport or a driver's license for example. The e-ID system consists of security software installed on the verification unit and an e-ID that is downloaded from a trusted provider's website or provided by the trusted provider via a smart card.

[0401] The verification unit may consist of SMS-based two-factor authentication software. Other two-factor authentication systems may also be used. Two-factor authentication requires two things to be authenticated: something you know (a password, a code, etc.) and something you have (an additional security code from a mobile device (e.g. SMS or e-ID), or a physical token such as a smart card).

[0402] Other authentication methods may also be employed, such as a verification unit that uses visible light to communicate with an external device instead of wired or wireless communication. A light source in the verification unit transmits (e.g., blinks in different patterns) a secret key or the like to the external device, and the external device can use the received data to verify the user, decrypt the data, or otherwise perform authentication. Light is advantageous in this context because it is easier to block or hide from an eavesdropping adversary than radio waves. In a similar embodiment, electromagnetic radiation is used instead of visible light to transmit the verification data to the external device.

[0403] Parameters related to the functionality of the implant may be the subject of communication and may constitute sensitive information, such as, for example, battery level, version of the control program, characteristics of the implant, status indicators of the implant, such as the status of the implant's motor, etc. Furthermore, data consisting of operating instructions may be the subject of communication and may consist of other sensitive information, such as, for example, new or updated control programs, parameters related to the specific configuration of the implant, etc. Such data may consist of, for example, instructions on how to operate the electrical stimulation device and / or the implantable constriction device, instructions to collect patient data, instructions to send feedback, etc. These parameters and data must be protected against disclosure.

[0404] [controller] A controller for controlling an implantable medical device according to any of the embodiments disclosed herein and for communicating with devices and / or implantable sensors outside the patient's body will now be generally described with reference to Figs. 16A-16C. Fig. 16A shows a patient when an implantable medical device M including a control device 300 is implanted, such as a constriction device in the form of outlet and inlet valves 30, 40 and / or electrical stimulation device 10 with control devices CI and / or CE as described above. The implantable medical device M comprises an active unit 302 which is part of an electrical stimulation device and / or a mechanical or hydraulic constriction device and constitutes one or more operable elements, valves, ports, etc. The active unit 302 is directly or indirectly connected to the patient's body for acting on the intestine. The active unit 302 is connected to the control device 300 via an electrical connection C2. The controller 300 (further described with reference to Fig. 16B) is configured to communicate with an external device 320 (further described with reference to Fig. 16C). The controller 300 can wirelessly communicate with an external device 320 via a wireless connection WL1 and / or via an electrical connection C1.

[0405] Referring now to FIG. 16B, one embodiment of the controller 300 will be described in more detail. The controller 300 comprises an internal computing unit 306 configured to control functions performed by the implantable medical device MD. The computing unit 306 comprises an internal memory 307 configured to store programs therein. In the embodiment depicted in FIG. 13b, the internal memory 307 includes a first control program 310 capable of controlling functions of the implantable medical device MD. The first control program 310 can be considered a program with minimal functionality that is executed in the implantable medical device M only during updates of the second control program 312. When the implantable medical device M is running with the first control program 310, the implantable medical device M can be considered to be running in a safe mode with reduced functionality. For example, this may result in no sensor data being stored in the implantable medical device M while the first control program 310 is running, or no feedback being transmitted from the implantable medical device M while the first control program 310 is running. Having a low complexity first control program conserves memory in the implantable medical device M and reduces the risk of the implantable medical device M failing while the second control program 312 is being updated.

[0406] The second control program 312 is a program that normally controls the implantable medical device M and provides the implantable medical device M with its complete functionality and features.

[0407] The memory 307 may further include an updatable second control program 312. The term updatable is interpreted as a program configured to receive incremental or iterative updates to its code or to be replaced by a new version of the code. The updates may correct previous defects in the code as well as provide new and / or improved functionality to the implant. The computing unit 306 may receive updates to the second control program 312 via the controller 300. The updates may be received wirelessly via the WL1 or via the electrical connection C1. As shown in FIG. 16B, the internal memory 307 of the controller 300 may store a third program 314. The third program 314 may control the functions of the implantable medical device M, and the computing unit 306 may be configured to update the second program 312 to the third program 314. The third program 314 may be utilized when relaunching the original state of the second program 312. Thus, the third program 314 can be considered to provide a factory reset (e.g., return to factory settings) of the controller 300. In this manner, the third program 314 can be included in the implant 300 in a secure portion of the memory 307 to be used to reset the software found in the controller 300 (the second control program 312) to the original manufacturer's settings.

[0408] The control device 300 may include a reset function 316 connected to, part of, or transmitted to the internal computing unit 306. The reset function 316 is configured to cause the internal computing unit 306 to switch from executing the second control program 312 to executing the first control program 310. The reset function 316 may be configured to cause the internal computing unit 306 to delete the second control program 312 from the memory 307. The reset function 316 may be operated by palpating or pressing the patient's skin. This may be done by providing a button on the implant. Alternatively, the reset function 316 may be invoked via a timer or a reset module. Temperature and / or pressure sensors may be utilized to sense the palpation. The reset function 316 may also be activated by penetrating the patient's skin. It is further plausible that the reset function 316 may be operated by magnetic means. This may be done by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 may be configured to only respond to magnetic forces applied for a time exceeding a limit, such as 2 seconds. The time limit may similarly be 5 seconds, 10 seconds, or more. In such cases, the implant may include a timer. Thus, the reset function 316 may include or be connected to a sensor for sensing such magnetic forces.

[0409] In addition to or as an alternative to the reset function described above, the implant may comprise an internal computing unit 306 (including an internal processor) that includes a second control program 312 for controlling functions of the implantable medical device M, and a reset function 318. The reset function 318 may be configured to restart or reset said second control program 312 in response to i. a timer of the reset function 318 not being reset, or ii. a malfunction of the first control program 310.

[0410] The reset function 318 may be comprised of a first reset function, for example a suitably operating computer, COP, function, etc., connected to the internal computing unit 306. The first reset function may be configured to restart or reset the first or second control program 312 with a second reset function. The first reset function may be comprised of a timer, and the first or second control program is configured to periodically reset the timer.

[0411] The reset function 318 may further include a third reset function connected to the internal computing unit and the second reset function. The third reset function may be configured to trigger a correction function to correct the first control program 310 or the second control program 312, as an example, and the second reset function is configured to restart the first control program 310 or the second control program 312 at some point after the correction function is triggered. The correction function may be a soft reset or a hard reset.

[0412] The second or third reset function may be configured to invoke a hardware reset, for example, by triggering a hardware reset by activating an internal or external pulse generator configured to generate a reset pulse. Alternatively, the second or third reset function may be implemented by software.

[0413] The controller 300 may further include an internal wireless transceiver 308. The transceiver 308 communicates wirelessly with an external device 320 via wireless connection WL1. The transceiver may further communicate with the external devices 320, 300 via wireless connections WL2 or WL4. The transceiver may transmit and receive data via any of connections C1, WL1, WL2, WL4. Optionally, the external devices 320, 300 may communicate with each other, for example, via wireless connection WL3, if present.

[0414] The controller 300 may further be electrically connected C1 to an external device 320 and communicate using the patient's body as a conductor. Thus, the controller 300 may configure a wired transceiver 303 or an internal transceiver 303 for the electrical connection C1.

[0415] The control device 300 of the implantable medical device M according to FIG. 16B further comprises a feedback unit 349. The feedback unit 349 provides feedback related to the switch from the second control program 312 to the first control program 310. The feedback can represent, for example, information when the update of the software, i.e. the second control program 312, is started and when the update is finished. This feedback can be visually conveyed to the patient, for example via a display on the external device 320. This display can be located on a watch, a phone or any other external device 320 coupled to the controller 300. Preferably, the feedback unit 349 provides this feedback signal wirelessly to the external device 320 via WL1. Possibly, the words "update started", or "update finished", or similar words with the same meaning, can be displayed to the patient. As another option, different colors can be displayed, for example green means that the update is finished and red or yellow means that the update is in progress. Of course, any color is equally valid and the user can choose between these according to personal preferences. Another possibility is to have the external device 320 flash a light. In this case, the external device 320 constitutes the required light emitting device. Such a light may be, for example, an LED. Different colors may also represent the status of the program update. One way to indicate that the update is ongoing and not yet finished may be to make the light blink, i.e. turn it on and off. When the light stops blinking, the patient knows that the update is finished. The feedback may also be audible and may be provided directly by the implanted constriction device M or by the external device 320. In that case, the implanted medical device M and the external device 320 comprise means for providing sound. The feedback may also be tactile, for example in the form of a vibration that can be sensed by the user. In such a case, either the implanted medical device M or the external device 320 constitutes the means for providing tactile sensations, such as vibrations and / or vibrators.

[0416] As seen in FIG. 16B, the controller 300 may further comprise a first energy storage unit 40A. The first energy storage unit 40A executes a first control program 310. The controller 300 may further comprise a second energy storage unit 40B executing a second control program 312. This may further increase security during updates since the first control program 310 has its own separate energy storage unit 40A. The first power source 40A may comprise a first energy store 304a and / or a first energy receiver 305a. The second energy storage unit 40B may consist of a second energy store 304b and / or a second energy receiver 305b. Energy may be received wirelessly by inductive or conductive means. The external energy storage unit may transfer an amount of wireless energy to the energy receivers 305a, 305b within the patient's body, for example by utilizing an external coil that induces a voltage in an internal coil (not shown). It is plausible that the first energy receiver 305a receives energy via RFID pulses. The feedback unit 349 can provide feedback related to the amount of energy received via RFID pulses. The amount of energy of the received RFID pulses can be adjusted based on the feedback to continuously increase the pulse frequency until a satisfactory level is reached.

[0417] The control device 300 of the implantable medical device M according to FIG. 16B further comprises an electric switch 309. The electric switch 309 may be mechanically connected to an implantable element configured to exert a force on a body part of the patient and configured to be switched as a result of the force exerted on the body part of the patient exceeding a threshold value. The switch 309 may, for example, be attached to a part of the implantable medical device M in any of the embodiments herein. The switch 309 may alternatively be electrically connected to the implantable medical device M and configured to be switched as a result of the current supplied to the implantable medical device M exceeding a threshold value. The switch 309 may, for example, be connected to the electrical stimulation device 10 and / or the constriction device in the form of the outlet valve 30 and the inlet valve 40 and configured to be switched if the current to the implantable medical device M exceeds a threshold value. Such a switch may, for example, be a switch 309 configured to be switched when exposed to a temperature exceeding a threshold value, such as a bimetallic switch that is switched by heat generated by the flow of current to the electrodes of the electrical stimulation device 10 or the motor of a mechanical or hydraulic constriction device, etc. Alternatively, switch 309, configured to switch when exposed to a temperature above a threshold, can be located elsewhere in implantable medical device M to switch when the temperature is exceeded, thereby preventing implantable medical device M from overheating, which could cause tissue damage.

[0418] The switch 309 is configured to either cut power to the operating device or generate a control signal to the processor 306 of the implantable controller 300, which enables the controller 300 to take appropriate action, such as reducing power or turning off operation of the implantable medical device M.

[0419] The external device 320 is depicted in FIG. 16C. The external device 320 may be placed anywhere on the patient's body, preferably in a convenient and comfortable location. The external device 320 may be a wristband and / or have the shape of a watch. It is also plausible that the external device is a mobile phone or other device not directly attached to the patient. As shown in FIG. 16C, the external device 320 comprises a wired transceiver 323 and an energy storage device 324. It is also plausible that the external device is a wireless transceiver 328 and an energy transmitter 325. It is further plausible that the external device 320 comprises a computing unit 326 and a memory 327. A feedback unit 322 in the external device 320 is configured to provide feedback related to the computing unit 326. The feedback provided by the feedback unit 322 may be visual. The external device 320 may have a display to show such visual feedback to the patient. It is equally plausible that the feedback is audible and the external device 320 comprises a means for providing sound. The feedback given by the feedback unit 322 may be tactile, such as vibration. Feedback may also be provided in the form of radio signals WL1, WL2, WL3, WL4.

[0420] The second, third or fourth communication means WL2, WL3, WL4 may be in the form of wireless communication. The second, third or fourth communication methods WL2, WL3, WL4 may preferably be in the form of electromagnetic wave or radio based communication. The second, third or fourth communication methods WL2, WL3, WL4 may be based on telecommunication methods. The second, third or fourth communication methods WL2, WL3, WL4 may consist of or relate to the items in the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (second generation cellular technology), 3G, 4G or 5G.

[0421] The external device 320 may be adapted to make electrical connection C1 with the implantable medical device M using the body as a conductor. In this case, the electrical connection C1 is used for conductive communication between the external device 320 and the implantable medical device M.

[0422] [Encryption / Decryption] In one embodiment, communications between the controller 300 and the external device 320 via any of the communication schemes WL2, WL3, WL4, C1 may be encrypted and / or decrypted with public and / or private keys. For example, the controller 300 may be configured with a private key and a corresponding public key, and the external device 320 may be configured with a private key and a corresponding public key.

[0423] The controller 320 and the external device 320 can exchange public keys and communicate using public key encryption. Those skilled in the art can utilize known methods for exchanging keys.

[0424] The controller may encrypt data to be sent to the external device 320 using a public key corresponding to the external device 320. The encrypted data is sent to the external device via wired, wireless, or electrical communication channels C1, WL1, WL2, WL3. The external device 320 may receive the encrypted data and decrypt it using a private key configured in the external device 320 (a private key corresponding to the public key with which the data was encrypted). The external device 320 may send the encrypted data to the controller 300. The external device 320 may encrypt the data to be sent using a public key corresponding to the private key of the controller 300. The external device 320 may send the encrypted data to the implant's controller directly or indirectly via wired, wireless, or electrical connections C1, WL1, WL2, WL3, WL4. The controller may receive the data and decrypt it using a private key included in the controller 300.

[0425] As an alternative to the public key encryption described with reference to Figures 16A-16C, data transmitted between the controller 300 of the implantable medical device M and the external devices 320, 330, or between the external devices 320, 330 and the controller 300, may be signed. In the method of transmitting data from the controller 300 to the external devices 320, 330, the data transmitted from the controller 300 may be signed using the private key of the controller 300. The data may be transmitted via communication channels or connections C1, WL1, WL2, WL3, WL4. The external devices 320, 330 may receive the message and verify the authenticity of the data using the public key corresponding to the private key of the controller 300. In this way, the external devices 320, 330 may determine that the data was transmitted from the controller 300 and not from another device or source.

[0426] A method of communicating between the external device 320 and the controller 300 of the implantable medical device M using a composite key will now be described with reference to Figs. 16A-16C. A first step of the method consists of receiving, at the implant, a first key from the external device 320, 330 by wireless transmission WL1, WL2, WL3, WL4, etc. The method further comprises receiving, at the implant, a second key by wireless communication WL1, WL2, WL3. The second key may be generated by a second external device separate from the external device 320, 330, or may be generated by another external device which is a generator of the second key on behalf of the second external device 320, 330. The second key may be received at the implant from any one of the external device 320, the second external device 330, and the generator of the second key. The second external device may be controlled by a caretaker or other party. The other external device may be controlled by the implant manufacturer, or by medical staff, a caretaker, etc.

[0427] If the controller 300 is receiving the second key from the external device 320, this means that the second key is routed through the external device, either from the second external device 330 or from another external device (generator). The routing may be performed as described herein in the tenth aspect. In these cases, the implant and / or the external device are provided with the necessary features and functions (described in the respective sections of this document) to perform such routing. The use of the external device 320 as a relay, with or without confirmation from the patient, may provide an additional layer of security, since the external device 320 may not need to store or otherwise handle the decrypted information. As such, the external device 320 may be lost without losing the decrypted information. The controller 300 comprises a computing unit 306 configured to derive a combined key by combining the first and second keys with a third key held by the controller 300 (e.g., in the memory 307 of the controller 300). The third key may be, for example, the license number of the implant or the chip number of the implantable medical device MD. The combined key may be used by the computing unit 306 to decrypt encrypted data transmitted by wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used by the computing unit 306 to modify the operation of the implantable medical device M. Modifying the operation of the implantable medical device M may include controlling or switching the implanted active unit 302. In some embodiments, the method further includes at least one of updating a control program running in the controller 300 based on the decrypted data and operating the implantable medical device M using operational instructions in the decrypted data.

[0428] A method for encrypted communication between an external device 320 and a controller 300 may be configured as follows: - receiving, at the external device 320, by the wireless transceiver 328, a first key, the first key being generated by a second external device 330 separate from the external device 320 or by another external device that is a generator of the second key on behalf of the second external device 330, the first key being received from either the second external device 330 or the generator of the second key; - receiving at the external device 320 by the wireless transceiver 328 the second key from the controller 300; - the computing unit 326 of the external device 320 derives a combined key by combining the first key and the second key with a third key held by the external device 320 (e.g. in the memory 307); - transmitting encrypted data from the implant to an external device and receiving encrypted data at the external device by the wireless transceiver 328; The computation unit 326 decrypts the encrypted data in the external device 320 using the combined key.

[0429] As mentioned above, additional keys may be required to decrypt the data. As a result, the wireless transceiver 328 is configured as follows: - receiving a fourth key from a third external device; Here, the computation unit 326 is configured as follows: - combining the first, second and fourth keys with a third key held by the external device to derive a combined key; - Decrypt the encrypted data using the combined key.

[0430] These embodiments provide additional security in the communication. The computing unit 326 may be configured to validate the communication between the implant and the external device, where the validation comprises: - measuring a patient parameter by an external device 320; - receiving measured parameters of the patient from the implantable medical device M; - comparing the parameters measured by the implantable medical device M with the parameters measured by the external device 320; - Check the connection based on comparison; - Upon confirmation, the encrypted data is decrypted on an external device.

[0431] In some embodiments, the keys described in this section may be generated based on data sensed by sensors, as described below. A seed is an initial value that is input into a pseudo-random number generator to start the random number generation process. This allows the seed to be difficult to predict without access to or knowledge of the patient's physiological parameters on which it is based, providing additional security to the generated keys.

[0432] [Communication method] Next, a method of communication between the external device 320 and the implantable medical device MD when the implantable medical device MD is implanted in a patient and the external device 320 is placed outside the patient's body will be described with reference to Figs. 16A-16C. The external device 320 is adapted to be in electrical connection C1 with the controller 300 using the body as a conductor. The electrical connection C1 is used for conductive communication between the external device 320 and the implantable medical device MD. The implantable medical device MD constitutes the controller 300. Both the controller 300 and the external device 320 constitute a wireless transceiver 308 for wireless communication C1 between the controller 300 and the external device 320. The wireless transceiver 308 (included in the controller 300) can constitute a sub-transceiver for receiving data from the external device 320 and other external devices in some embodiments, e.g., using different frequency bands, modulation schemes, etc.

[0433] In a first step of the method, the electrical connection C1 between the controller 300 and the external device 320 is verified and thus authenticated. The verification and authentication of the electrical connection can be performed as described below. In such cases, the implant and / or the external device are provided with the necessary features and functions (described in the respective sections of this document) to perform such authentication. Performing the authentication according to these aspects may increase the security of the authentication, since a malicious third party may require knowledge or access to the patient's transient physiological parameters or to detect randomized sensations occurring at or within the patient.

[0434] The controller 300 of the implantable medical device MD may include a first transceiver 303 configured to be in electrical connection C1 with the external device 320 using the body as a conductor. Alternatively, the first transceiver 303 of the controller 300 may be wireless. The external device 320 may include a first external transmitter 323 configured to be in electrical connection C1 with the implantable medical device M using the body as a conductor, and a wireless transmitter configured to transmit a wireless communication WL1 to the controller 300. Alternatively, the first external transmitter 323 of the external device 320 may be wireless. The first external transmitter 323 and the wireless transmitter of the external device 320 may be the same transmitter or may be separate transmitters.

[0435] The controller 300 may include a computing unit 306 configured to verify an electrical connection between the external device 320 and the internal transceiver 303, and to accept a wireless communication (of data) WL1 from the external device 320 based on the verification.

[0436] The data is transmitted from the external device 320 to the controller 300, for example wirelessly using wireless transceivers in the controller 300 and the external device 320. The data may alternatively be transmitted via the electrical connection C1. Upon verification, the received data may be used to instruct the implantable medical device MD, for example by updating the control program 310 running in the controller 300 or by operating the controller 300 using the operating instructions in the received data, which may be processed by the computing device 306.

[0437] The method may comprise wirelessly transmitting data from the external device 320 to the controller 300, and may comprise wirelessly transmitting encrypted data. To decrypt the encrypted data (e.g., using the computing unit 306), several methods may be used.

[0438] In one embodiment, a key is transmitted from the external device 320 to the controller 300 using the confirmed conductive communication path C1 (i.e., an electrical connection). The key is received at the controller (by the first internal transceiver 303). The key is then used to decrypt the encrypted data.

[0439] In one embodiment, the key alone is sufficient to decrypt the encrypted data. In other embodiments, an additional key is required to decrypt the data. In one embodiment, the key is transmitted from the external device 320 to the controller 300 using a confirmed conductive communication channel C1 (i.e., an electrical connection). The key is received at the controller 300 (by the first internal transceiver 303). A second key is transmitted from the external device 320 using wireless communication WL1 (by the wireless transceiver 208) and received at the controller 300 by the wireless transceiver 308. The computing unit 306 then derives a combined key from the key and the second key, which is used to decrypt the encrypted data.

[0440] In yet another embodiment, a key is transmitted from the external device 320 to the controller 300 using the confirmed conductive communication path C1 (i.e., electrical connection). The key is received at the controller (by the first internal transceiver 303). A third key is transmitted wirelessly to the implant over WL2 from a second external device 330 separate from the external device 320. The third key may be received by a second wireless receiver (part of the wireless transceiver 308) of the controller 300 configured to receive wireless communication over WL2 from the second external device 330.

[0441] The first and third keys may be used by the computing unit 306 to derive a combined key, which then decrypts the encrypted data. The decrypted data is then used to instruct the implantable medical device MD as described above.

[0442] The second external device 330 may be controlled, for example, by a caregiver, to further enhance the security and validity of the data transmitted and decoded by the controller 300.

[0443] It should be noted that in some embodiments, the external device is further configured to receive a secondary wireless communication WL2 from the second external device 330 and transmit data received from the secondary wireless communication WL2 to the implantable medical device MD. This routing of data may be accomplished using the wireless transceiver 308, 208 (i.e., wireless connection WL1) or using a further wireless connection WL4 between the controller 300 and the external device 320. In these cases, the implant and / or the external device comprise the necessary features and functions to perform such routing. As a result, in some embodiments, the third key is generated by the second external device 330 and transmitted to the external device 320 via WL2, which routes the third key to the controller 300, which is used for decrypting the encrypted data. In other words, the step of wirelessly transmitting the third key from a second external device separate from the external device to the implant consists of routing the third key via the external device 320. The use of the external device 320 as an intermediary, with or without patient verification, can provide an additional layer of security by eliminating the need for the external device 320 to store or otherwise handle the decrypted information, and thus the external device 320 can be lost without losing the decrypted information.

[0444] In yet another embodiment, the key is transmitted from the external device 320 to the controller 300 using the confirmed conductive communication channel C1 (i.e., electrical connection). The key is received at the implant (by the first internal transceiver 303). A second key is wirelessly transmitted from the external device 320 to the controller 300 over WL1 and received at the controller 300. A third key is wirelessly transmitted from a second external device, separate from the external device 320, to the controller 300 over WL4. Encrypted data transmitted from the external device 320 to the controller 300 is decrypted using a composite key derived from the key, the second key, and the third key. The external device may be a wearable external device.

[0445] The external device 320 may be a mobile phone. The second external device 330 may be a handset, a server, or cloud-based.

[0446] In some embodiments, the electrical connection C1 between the external device 320 and the controller 300 is achieved by placing a conductive member 321 configured to interface with the external device 320 in electrical connection with the patient's skin for conductive communication C1 with the implant. In such cases, the implant and / or the external device include the necessary features and functionality (described in the various sections herein) to effect such conductive communication. Thus, an additional layer of security may be provided in addition to encryption by the communication being electrically confined to the conductive path of the external device 320, the conductive member 321, the conductive connection C1, the controller 300, etc., meaning that the communication is unduly difficult to intercept by a third party not in physical contact with the patient or at least not in close proximity to the patient.

[0447] [Authentication / Verification] To further increase the security of the communication between the controller 300 and the external device 320, different types of authentication, verification, and / or encryption can be employed. In some embodiments, the external device 320 comprises a verification unit 340. The verification unit 340 may be any type of unit suitable for user verification, i.e. a unit configured to receive authentication input from the user, in order to authenticate the conductive communication between the implant and the external device. In some embodiments, the verification unit and the external device comprise means for collecting authentication input from the user (who may or may not be a patient). Such means may consist of a fingerprint reader, a retina scanner, a camera, a GUI for entering a code, a microphone, a device configured to draw blood, etc. Thus, the authentication input may consist of a code or anything based on a biometric technique selected from the list of fingerprints, palm vein structure, image recognition, face recognition, iris recognition, retina scan, hand geometry, and genome comparison. The means for collecting authentication input may instead be part of the conductive member 321 constituting any of the above example functions, such as a fingerprint reader or other type of biometric reader.

[0448] In some embodiments, security can be enhanced by receiving an authentication input from a user by a verification unit 340 of the external device 320 and using the authentication input to authenticate the conductive communication between the controller 300 and the external device. If authentication is positive, the conductive communication channel C1 is used to configure the external device 320 to transmit conductive communications to the controller 300 and / or the controller 300 to transmit conductive communications to the external device 320. In other embodiments, positive authentication is required before operating the implantable medical device MD based on received conductive communications and / or before updating a control program running in the controller 300 as described above.

[0449] 16A-16C further show that the implantable medical device MD is connected to a sensation generator 381. The sensation generator 381 may be configured to generate sensations. The sensation generator 381 may be included within the implantable medical device MD or may be a separate unit. The sensation generator 381 may be implanted. Alternatively, the sensation generator 381 may not be so implanted but may be arranged to be connected to the patient such that only the patient can experience the generated sensations. The controller 300 is configured to store authentication data associated with the sensations generated by the sensation generator 381.

[0450] The controller 300 is further configured to receive input authentication data from the external device 320. The authentication data associated with the generated sensation may be stored by the memory 307 of the controller 300. The authentication data may include information about the generated sensation such that it may be analyzed, such as compared to the input authentication data, to authenticate the connection, communication, or device. The input authentication data is associated with information generated by a patient inputting into the external device 320. The input authentication data may be actual patient input or an encoded version of the patient input encoded by the external device 320. The authentication data and the input authentication data may be comprised of multiple sensations or sensory components.

[0451] The authentication data may include a timestamp. The input authentication data may consist of a timestamp of the input from the patient. The timestamp may be the time of an event such as the generation of a sensation by the sensation generating device 381 or the creation of the input authentication data by the patient. The timestamp may be encoded. The timestamp may feature any unit of time rather than an actual time. The timestamp may be provided by an internal clock 360 of the controller 300 and an external clock 362 of the external device 320. The clocks 360, 362 may be synchronized with each other. The clocks 360, 362 may be synchronized by using a conductive connection C1 or a wireless connection WL1 to communicate synchronization data from the external device 320 and its respective clock 362 to the controller 300 and its respective clock 360, and vice versa. The synchronization of the clocks 360, 362 may be performed continuously and may not rely on secure communication.

[0452] Authentication of the connection consists of calculating the time difference between the timestamp of the sensation and the timestamp of the patient input, and authenticating the connection when it is determined that the time difference is less than a threshold. An example threshold is 1 second. The analysis may also be configured with a low threshold to filter input from the patient that is faster than normal human response times. An example low threshold is 50 ms.

[0453] The authentication data comprises a number of times the sensation generator generated a sensation, the input authentication data comprises input from the patient regarding a number of times the patient detected the sensation, and authenticating the connection comprises authenticating the connection upon determining that the number of times of the authentication data and the input authentication data are equal.

[0454] A method for authenticating a connection between an implantable medical device MD and an external device 320 optionally includes the following steps.

[0455] The sensation generating device 381 generates a sensation detectable by the patient's senses. The sensation may be composed of multiple sensory components. The sensation or sensory components may consist of vibration (e.g., mechanical vibration of a certain frequency), sound (e.g., superposition of mechanical vibrations of certain frequencies), optical signals (e.g., non-visible light pulses such as infrared pulses), light signals (e.g., visible light pulses), electrical signals (e.g., current pulses), or thermal signals (e.g., heat pulses). The sensation generator may be implantable, configured to be worn in contact with the patient's skin, or capable of generating a sensation without physical contact with the patient, such as a beeping alarm. The sensation may be configured to be consistently felt by the patient's senses while not risking harm or affecting the patient's internal biological processes.

[0456] The controller 300 stores authentication data associated with the generated sensation.

[0457] The input authentication data may be provided by the patient through input into the external device, such as by actuating an electrical switch, using a biometric input sensor, or through input into a digital interface running on the external device 320, to name a few examples.

[0458] The input authentication data is transmitted from the external device to the controller 300. When the step is executed, the control device 300 may perform an analysis.

[0459] Transmit authentication data from the implantable medical device MD to the external device 320. If the step is performed, an analysis may be performed by the external device 320. The wireless connection WL1 or the conductive connection C1 may be used to transmit the authentication data or input authentication data.

[0460] Authenticating the connection based on the input authentication data and an analysis of the authentication data, e.g., comparing the number of sensations generated and sensations experienced, or comparing a timestamp of the authentication data and the input authentication data. If the step is performed, the analysis may be performed by the implantable medical device MD.

[0461] Following positive authentication, further data is communicated between the controller 300 and the external device 320. The further data can be communicated using the wireless connection WL1 or the conductive connection C1. The further data may consist of data for updating the control program 310 running within the controller 300 or operating instructions for operating the implantable medical device M.

[0462] When the analysis is performed by the controller 300, the external device 320 continually requests or receives information on the authentication status of the connection between the controller 300 and the external device 320, and once the external device 320 determines that the connection is authenticated, further data may be sent from the external device 320 to the controller 300.

[0463] If the analysis is performed by the external device 320, the controller 300 may continually request or receive information on the authentication status of the connection between the controller 300 and the external device 320, and if the controller 300 determines that the connection is authenticated, further data may be sent from the controller 300 to the external device 320.

[0464] A major advantage of authenticating a connection according to this method is that only the patient experiences the sensation, and therefore only the patient can authenticate the connection by providing an authentication input that corresponds to the occurrence of the sensation.

[0465] [Security Module] According to one embodiment described with reference to Figures 16A-16C, the communication unit 300 or internal controller 300 or control unit 300 comprises a wireless transceiver 308 for wireless communication with an external device, a security module 389 and a central unit, also referred to herein as computing unit 306, which are considered equivalent. The central unit 306 is configured to communicate with the wireless transceiver 308, the security module 389 and the implantable medical device or active unit 302. The wireless transceiver 308 is configured to receive a communication from the external device 320 including at least one instruction for the implantable medical device MD and to transmit the received communication to the central unit or computing unit 306. The central unit or computing unit 306 is configured to transmit a secure communication derived from the received communication from the external device 320 to the security module 389, which is configured to decrypt at least a portion of the secure communication and verify the authenticity of the secure communication. The security module is further configured to transmit the response communication to a central unit or computing unit 306, which is configured to communicate at least one instruction to the active unit 302. In the embodiment shown in Figures 16A-16C, the at least one instruction is based on the response communication or a combination of the response communication and a received communication from the external device 320.

[0466] In the embodiment shown in Figures 16A-16C, the security module 389 is configured with a set of rules for accepting communications from the central unit or computing unit 306. In the embodiment shown in Figures 16A-16C, the wireless transceiver 308 is configured such that it can be placed in an off mode, in which no wireless communications are transmitted or received by the wireless transceiver 308. The set of rules comprises a rule that provides that communications are accepted from the central unit or computing unit 306 to the security module 389 or active unit 302 only when the wireless transceiver 308 is placed in the off mode.

[0467] In the embodiment shown in Figures 16A-16C, the set of rules consists of a rule that specifies that communications from the central unit or computing unit 306 are accepted only if the wireless transceiver 308 is placed in an off mode for a certain period of time.

[0468] In the embodiment shown in Figures 16A-16C, the central or computing device 306 is configured to verify a digital signature of a received communication from the external device 320. The digital signature may be a hash-based digital signature based on a biometric signature from the patient or medical professional. The set of rules further includes a rule that specifies that the communication from the central device 306 is accepted only if the digital signature of the received communication is verified by the central device 306. The verification may include, for example, comparing the digital signature or a portion of the digital signature with a previously verified digital signature stored in the central unit 306. The central device 306 may be configured to verify a size of a received communication from the external device, and the set of rules may include a rule that specifies that the communication from the central device 306 is accepted only if the size of the received communication is verified by the central device 306. Thus, the central device may have rules that specify that communications above or below a specified size range are rejected.

[0469] In the embodiment shown in Figures 16A-16C, the wireless transceiver is configured to receive a message from an external device 320 that is encrypted with at least a first layer and a second layer of encryption. The central unit 306 decrypts the first layer of encryption and transmits at least a portion of the message that constitutes the second layer of encryption to the security module 389. The security module 389 then decrypts the second layer of encryption and transmits a response communication to the central unit 306 based on the portion of the message decrypted by the security module 389.

[0470] In the embodiment shown in Figures 16A-16C, the central unit 306 is configured to decrypt a portion of the message that constitutes the digital signature, such that the digital signature can be verified by the central unit 306, and the central unit 306 is configured to decrypt a portion of the message that constitutes the message size information, such that the message size can be verified by the central unit 306.

[0471] In the embodiment shown in Figures 16A-16C, the central device 306 is configured to decrypt a first part and a second part of the message, where the first part comprises a checksum to verify the authenticity of the second part.

[0472] In the embodiment shown in Figures 16A-16C, the response communication sent from security module 389 includes a checksum, and central device 306 is configured to verify the authenticity of at least a portion of the message decrypted by central device 306 using the received checksum, i.e., by adding a portion of the message decrypted by central device 306 and comparing the sum to the checksum.

[0473] 16A-16C, the rule set further includes a rule related to the data transfer rate between the central unit 306 and the security module 389. The rule may stipulate that communication should be refused or terminated if the data transfer rate exceeds a configured maximum data transfer rate, making it more difficult for an unauthorized party to inject malicious code or instructions into the medical implant.

[0474] 16A-16C, the security module 389 is configured to decrypt the portion of the message, including the digital signature, that is encrypted with a second layer of encryption, such that the digital signature can be verified by the security module 389. The security module 389 then sends a response communication to the central unit 306 based on the result of the verification, which response communication can be used by the central unit 306 for further decryption of the message or to determine whether instructions in the message should be communicated to the active unit 302.

[0475] 16A-16C, the central unit 306 can only decrypt some of the incoming communications from the external device 320 when the wireless transceiver 308 is placed in off mode. As an alternative, or as an additional layer of security, the central unit 306 can be restricted to only be able to communicate instructions to the active unit 302 of the implantable medical device MD when the wireless transceiver 308 is placed in off mode, so that no attack can be carried out while the central unit 306 is communicating with the active unit 302.

[0476] In the embodiment shown in Figures 16A-16C, the embedded controller 300 is configured to receive, using the wireless transceiver 308, a message from an external device 320 that includes a first unencrypted portion and a second encrypted portion. The embedded controller 300 (e.g., the central unit 306 or the security module 389) then decrypts the encrypted portion and uses the decrypted portion to verify the authenticity of the unencrypted portion. In this manner, computational power, and therefore energy, can be conserved by encrypting only those portions of the message necessary to authenticate the remainder (e.g., checksums and / or digital signatures) rather than encrypting the entire communication.

[0477] 16A-16C, the central device 306 is configured to transmit the encrypted portion to the security module 389 and receive a response communication from the security module 389 based on the information contained in the encrypted portion being decrypted by the security module. The central device 306 is then configured to verify the authenticity of the unencrypted portion using the response communication. The unencrypted portion may constitute at least a portion of at least one instruction for the implantable medical device 306.

[0478] 16A-16C, implantable controller 300 is configured to receive, using wireless transceiver 308, a message from external device 320 that includes information related to at least one of a physiological parameter of the patient and a physical parameter of implantable medical device MD, and to verify the authenticity of the message using the received information. The physiological parameter of the patient may be a parameter such as a parameter based on one or more of body temperature, heart rate, and saturation value.

[0479] The physical parameters of the implantable medical device MD may consist of at least one of the current settings or values ​​of the implantable medical device MD, advance instructions sent to the implantable medical device MD, or an ID of the implantable medical device MD.

[0480] Portions of the message containing information relating to the patient's physiological parameters and / or physical or functional parameters of the implanted medical device MD may be encrypted, and the central unit 306 may be configured to send the encrypted portions to the security module 389 and to receive a response communication from the security module 389 based on the information decrypted by the security module 389.

[0481] In the embodiment shown in Figures 16A-16C, the security module 389 is a hardware security module that comprises at least one hardware-based key. The security module 389 may have the ability to provide evidence of tampering, such as visual indications of tampering or logging and warnings. The security module 389 may also be "tamper resistant" to render the security module 389 inoperable if tampering is detected. For example, a response to tampering may be to delete the key if tampering is detected. The security module 389 is comprised of one or more secure crypto-processor chips. The hardware key of the security module 389 may have a corresponding hardware key that can be placed on the external device 320. The corresponding external hardware-based key may be on a key card that can be connected to the external device 320.

[0482] In alternative embodiments, security module 389 is a software security module including at least one software-based key, or a combination of a hardware-based security module and a software-based key. The software-based key may correspond to a software-based key in external device 320. The software-based key may correspond to a software-based key on a key card connectable to external device 320.

[0483] In the embodiment shown in Figures 16A-16C, the external device 320 is a handheld external device, however, in alternative embodiments, the external device may be a remote external device or a cloud-based external device.

[0484] In the embodiment shown in Figures 16A-16C, the at least one instruction to the implantable medical device MD includes an instruction to change an operational state of the implantable medical device MD.

[0485] 16A-16C, wireless transceiver 308 is configured to wirelessly communicate with external device 320 using electromagnetic waves at frequencies below 100 kHz, and more specifically below 40 kHz. As such, wireless transceiver 308 is configured to communicate with external device 320 using "very low frequency" communications (VLF). VLF signals have the ability to penetrate the titanium housing of implantable medical device MD, allowing the electronics of implantable medical device MD to be completely encapsulated within the titanium housing.

[0486] The wireless transceiver 308 is configured to wirelessly communicate with the external device 320 using a first communication protocol, and the central unit 306 is configured to communicate with the security module 389 using a second, different communication protocol. This provides an added layer of security, since security structures may be built into the electronic circuitry and / or software of the central unit 306 that allows for the transfer from the first communication protocol to the second communication protocol. The wireless transceiver 308 may be configured to wirelessly communicate with the external device using a standard network protocol, which may be one of an RFID type protocol, a WLAN type protocol, a Bluetooth (BT) type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol. Alternatively, or in combination, the wireless transceiver 308 may be configured to wirelessly communicate with the external device 320 using a proprietary network protocol. The wireless transceiver 308 may be configured as an ultra-wideband (UWB) transceiver, and the wireless communication between the implantable controller 300 and the external device 320 may thus be based on UWB. The use of UWB technology allows for positioning of the remote control 320'' that can be used as a way for the implantable medical device MD to determine that the external device 320 is in a location that the implantable medical device MD and / or patient can recognize as correct, for example within reach of the patient and / or in direct proximity to the medical device MD and / or patient, such as within one or two meters of the implantable medical device MD. Alternatively, UWB and BT can be used in combination, in which case UWB communication can be used to authenticate the BT communication since it is easier to transfer larger data sets using BT.

[0487] [Variable Impedance] According to one embodiment described with reference to Figs. 16A-16C, the communication unit 300 or controller of the implantable medical device MD comprises a receiving unit 305 or energy receiver 305 consisting of a coil 192 (specifically shown in Fig. 16B') configured to receive the transcutaneously transmitted energy. The receiving unit further comprises a measuring unit 194 configured to measure a parameter related to the energy received by the coil 192, and a variable impedance 193 electrically connected to the coil 192. The receiving unit 305 further comprises a switch 195a arranged between the variable impedance 193 and the coil 192 to turn off the electrical connection between the variable impedance 193 and the coil 192. The communication unit 300 or the control device 300 is configured to control the variable impedance 193 to vary the impedance, thereby adjusting the coil 192 based on the measured parameter. The communication unit 300 or the control device 300 is further configured to control the switch 195a to turn off the electrical connection between the variable impedance 193 and the coil 192 in response to the measured parameter exceeding a threshold value. The controller 300 may further be configured to vary the variable impedance in response to the measured parameter exceeding a threshold. In this way, if an excessive amount of energy is received, the coil may be adjusted or turned off to reduce the amount of energy received. The measurement unit 194 is configured to measure a parameter related to the energy received by the coil 192 over time and / or to measure a parameter related to the change in the energy received by the coil 192, for example by measuring the time derivative of the received energy. The variable impedance 193 is arranged in series with the coil 192 in the embodiment shown in FIG. 16B'. However, in other embodiments, it is also conceivable to arrange the variable impedance in parallel with the coil 192.

[0488] The first switch 195a is disposed at a first end portion 192a of the coil 192, and the implantable medical device MD further comprises a second switch 195b disposed at a second end portion of the coil 192 so that the coil 192 can be completely disconnected from other portions of the implantable medical device MD. The receiving unit 305 is configured to receive the transcutaneously transmitted energy in pulses according to a pulse pattern. The measuring unit 194 is configured to measure a parameter related to the pulse pattern in the embodiment shown in FIG. 16B'. The controller 300 is configured to control the variable impedance in response to the pulse pattern deviating from a predefined pulse pattern. The controller 300 is configured to control the switch 195a to turn off the electrical connection between the variable impedance 193 and the coil 192 in response to the pulse pattern deviating from the predefined pulse pattern. The measuring unit is configured to measure a temperature in the implantable medical device MD or in the patient's body, and the controller 300 is configured to control the first and second switches 195a, 195b in response to the measured temperature.

[0489] The variable impedance 193 may be composed of a resistor and a capacitor, and / or a resistor and an inductor, and / or an inductor and a capacitor. The variable impedance 193 may be composed of a digitally tuned capacitor or a digital potentiometer. The variable impedance 193 may be composed of a variable inductor. The first and second switches are composed of semiconductors such as MOSFETs. The variation of the impedance is configured to reduce the effective power received by the receiving unit. As seen in FIG. 16B', the variable impedance 193, the first and second switches 195a, 195b, and the measurement unit 194 are connected to the communication unit / controller 300, and the receiving unit 305 is connected to the storage unit 40 so that the storage unit 40 can store the energy received by the receiving unit 305.

[0490] [Multiple external devices with different permission levels for added security] FIG. 17 illustrates one embodiment of a system for charging, programming, and communicating with the controller 300 of an implantable medical device MD. FIG. 17 further illustrates the communication and interaction between different external devices, which may be devices held and operated by the patient, devices held and operated by a healthcare provider (HCP), or a dedicated data infrastructure (DDI), for example, an infrastructure provider by the manufacturer of the implantable medical device MD or the external devices 320′, 320″, 320′″. The system of the embodiment of FIG. 17 is composed of three external devices 320′, 320″, 320′″ that can communicate with the controller 300. The basic idea is to ensure security of communication with and operation of the medical device MD by having three external devices 320′, 320″, 320′″ with different levels of authority. The lowest level of authority is given to the patient operated remote control 320″. The remote control 320″ has the authority to operate the functions of the implantable medical device MD via the implantable controller 300 based on the patient's input. The remote control 320'' further has the authority to obtain the necessary data from the controller 300. The remote control 320'' can only operate the controller 300 by communicating with the software currently running on the controller 300 with the current settings or software. The next level of authority is given to the Patient-External Interrogation Device (P-EID) 320''', which is a charging and communication unit held by the patient but partially remotely operated by the Health Care Provider (HCP). (This is usually a doctor in a clinic who provides treatment with the help of the implanted medical device MD). The P-EID 320'' has the authority to make configuration changes to the software running on the controller 300 of the implanted medical device MD when remotely operated by the HCP. The highest level of authority is given to the HCP-EID 320', which is a charging and communication unit that the HCP holds physically at the HCP's clinic.The HCP-EID 320' has the authority to freely modify or replace the software running on the controller 300 when the patient is physically present at the clinic or HCP.

[0491] Starting from the lowest level of authority, the remote control 320'' comprises a wireless transceiver 328 for communicating with the implantable medical device MD. The remote control 320'' can control the operation of the implantable medical device MD via the controller 300 by controlling pre-configured functions of the implantable medical device MD, for example to operate active parts of the implantable medical device MD to perform the intended functions of the implantable medical device MD. In the embodiment shown in FIG. 17, the wireless transceiver 328 comprises a Bluetooth (BT) transceiver, and the remote control 320'' is configured to communicate with the implantable medical device MD using BT. In another configuration, the remote control 320'' communicates with the implantable medical device MD using a combination of ultra-wideband (UWB) wireless communication and BT. The use of UWB technology enables positioning of the remote control device 320'' which can be used as a way for the implantable medical device MD to determine that the remote control device 320'' is in a location that the implantable medical device MD and / or the patient will recognize as correct, for example, within reach of the patient and / or in direct proximity to the medical device MD and / or the patient, such as within one or two meters of the implantable medical device MD.

[0492] UWB communication is done by generating radio energy at specific time intervals and occupying a wide bandwidth, so that pulse position modulation and time modulation are possible. Information can also be modulated onto the UWB signal (pulse) by encoding the polarity of the pulse and / or its amplitude and / or by using orthogonal pulses. UWB radio systems can be used to determine the "time of flight" of transmissions at various frequencies. This helps to overcome multipath propagation, because some frequencies have line-of-sight trajectories, while other indirect paths have long delays. Distance can be measured with high resolution and accuracy through cooperative symmetric two-way photometry techniques. UWB is useful for real-time location information systems, and its high accuracy capabilities and low power make it suitable for radio frequency sensitive environments.

[0493] In embodiments where a combination of BT and UWB technologies is used, UWB technology can be used for location-based authentication of the remote control device 320″, and communication and / or data transfer can be performed using BT. In some embodiments, the UWB signal can also be used as a wake-up signal for the controller 300, or as a wake-up signal for the BT transceiver of the implantable medical device MD so that it is turned off when not in use, eliminating the risk of BT being intercepted or the controller 300 of the implantable medical device MD being hacked by BT communication. In embodiments where a combination of BT / UWB is used, the UWB connection can also be used for the transmission of data. Alternatively, the UWB connection can be used for the transmission of a portion of the data, such as a sensitive portion of the data, or for the transmission of a key to unlock encrypted communications sent via BT.

[0494] The remote control 320'' includes control logic that executes a control logic application for communicating with the implanted medical device MD. The control logic can receive input directly from control buttons 335 located on the remote control 320'' or from a control interface 334i displayed on a patient-operated display device 334. In an embodiment where the remote control 320'' receives input from a control interface 334i displayed on a patient-operated display device 334, the remote control 320'' transmits the control interface 334i in the form of a web view, i.e. a remote interface that runs in a sandbox environment on the patient's display device 334. The patient's display device 334 can be, for example, a mobile phone, a tablet or a smart watch. In the embodiment shown in FIG. 17, the patient's display device 334 communicates with the remote control 320'' by BT. The control interface 334i in the form of a web view is transmitted from the remote control 320'' to the patient's display device 334 via BT. Control commands in the form of inputs from the patient to the control interface 334i are sent from the patient display device 334 to the remote control 320'', providing inputs to the remote control 320'' equivalent to inputs that may be provided using the control buttons 335. Control commands created in the patient display device 334 are encrypted in the patient display device 334 and sent to the remote control 320' using BT.

[0495] The patient's display device 334 (when the display device 334 is a mobile phone or tablet) may include an auxiliary wireless transmitter to provide an auxiliary wireless connection, such as Wi-Fi or a mobile connection (e.g., according to 3G, 4G or 5G standards). The auxiliary wireless connection may need to be disconnected to enable communication with the remote control 320''. Disconnecting the auxiliary wireless connection reduces the risk that the integrity of the control interface 334i displayed on the patient's display device 334 is compromised or that the control interface 334i displayed on the patient's display device 334 is remotely controlled by an unauthorized device.

[0496] In alternative embodiments, the control commands are generated and encrypted by the patient's display device and sent to the DDI 330. The DDI 330 can either modify the generated control commands into commands readable by the remote control 320'' before further encrypting the control commands for sending to the remote control 320'', add an additional layer of encryption before sending the control commands to the remote control 320'', or simply act as a router to relay the control commands from the patient's display device 334 to the remote control 320''. It is also possible for the DDI 330 to add an end-to-end encryption layer directed to the implanted medical device MD, so that only the implanted medical device MD can decrypt the control commands and execute the commands intended by the patient.

[0497] The patient display device 334 may have a first and a second application related to the implanted medical device MD. The first application is a control application that displays a control interface 334i for controlling the implanted medical device MD, while the second application is a general application for providing the patient with an interface for providing general information to the patient about the status of the implanted medical device MD or information from the DDI 330 or HCP, or for providing general input to the DDI 330 or HCP related to the patient's general well-being, the patient's lifestyle, or general input from the patient about the functionality of the implanted medical device MD. The second application does not provide input to the remote control device 320'' and / or the implanted medical device MD, and therefore handles less sensitive data. As such, the general application may be configured to function even when all auxiliary wireless connections are activated, but may require temporary deactivation of the auxiliary wireless connections to switch to the control application that handles more sensitive control commands and communication with the implanted medical device MD. It is also possible that the control application is a sub-application running within the general application, in which case launching the control application as a sub-application within the general application may require temporary deactivation of the auxiliary wireless connections. In the embodiment shown in Figure 17, access to the control application requires the use of optical and / or NFC means of the hardware key 333' in combination with a biometric input on the patient's display device, whereas access to the general application requires only a biometric input and / or a pin code on the patient's display device. Alternatively, a two-factor authentication solution such as a digital key in combination with a pin code can be used for access to the general and / or control applications.

[0498] In embodiments where the patient's display device 334 is configured to only display a web view provided by another unit in the system, the web view may be a back-end view provided on the DDI 330; in such embodiments, patient interaction with the control interface on the patient's display device is equivalent to patient interaction with an area of ​​the DDI 330.

[0499] Referring now to the P-EID 320''', the P-EID 320''' is an external device that communicates with and charges the implantable medical device MD. The P-EID 320''' can be remotely controlled by an HCP to read information from the implantable medical device MD, control the operation of the implantable medical device MD, control the charging of the implantable medical device MD, and adjust settings for software running on the controller 300 of the implantable medical device MD, for example, by adding or deleting predefined program steps and / or by selecting predefined parameters within limited ranges. Similar to the remote control device 320'', the P-EID 320''' can be configured to communicate with the implantable medical device MD using BT or UWB communication. Similar to the remote control 320'', it is also possible to use a combination of UWB wireless communication and BT to enable positioning of the P-EID 320'' as a way of establishing that the P-EID 320'' is in a location that the implanted medical device MD and / or patient and / or HCP can recognize, such as being in direct proximity to the correct patient and / or correct medical device MD. Similar to the remote control 320'', in an embodiment where a combination of BT and UWB technology is used, UWB technology can be used for location-based authentication of the P-EID 320'', while communication and / or data transfer can be performed using BT. The P-EID 320'' comprises a wireless transceiver 328 for communication and a wireless transmitter 325 configured to wirelessly transfer energy in the form of a magnetic field to a wireless receiver 395 of the implanted medical device MD configured to receive energy in the form of a magnetic field and to convert the energy into electrical energy for storage in the implanted energy storage unit 40 and / or consumption in an energy consumer (e.g., operating device, controller 300) of the implanted medical device MD. The magnetic field generated at the P-EID and received at the implantable medical device MD is referred to as the “charging signal.” In addition to enabling wireless transfer of energy from the P-EID to the implantable medical device MD, the charging signal may also function as a communication means.For example, variations in transmission frequency and / or signal amplitude can be used as a signaling means to enable one-way communication from the P-EID to the implantable medical device MD or two-way communication between the P-EID and the implantable medical device MD. The charging signal in the embodiment shown in FIG. 17 is a signal in the range of 120-140 kHz and the communication follows a proprietary communication signal protocol, i.e. is not based on an open standard. In alternative embodiments, BT can be combined with communication using the charging signal or with UWB signals.

[0500] Similar to the remote control 320'', the UWB signal can also be used in some embodiments as a wake-up signal for the controller 300, or BT transceiver, so that the BT transceiver in the implantable medical device MD can be turned off when not in use, eliminating the risk of the BT being intercepted or the controller 300 of the implantable medical device MD being hacked by the BT communication. Alternatively, the charging signal can be used as a wake-up signal for the BT, since it does not travel very far. Also, the effect of the charging signal or RSSI can be evaluated by the controller 300 in the implantable medical device MD as a location-based authentication measure to establish that the transmitter is within a defined range. In a BT / UWB combination, UWB can also be used for the transmission of data. In some embodiments, the UWB and / or charging signal can be used for the transmission of a portion of the data, such as a sensitive portion of the data, or for the transmission of a key to unlock encrypted communications sent by the BT.

[0501] UWB can also be used to wake up the transmission of charging signals, to initiate wireless transfer of energy, and to initiate communication using charging signals. The signals for energy transmission have a very high effect compared to normal wireless communication signals, so the signals for energy transmission cannot be active all the time.

[0502] The P-EID 320'' communicates with the HCP over the internet by a secure communication such as a VPN. The communication between the HCP and the P-EID 320'' is preferably encrypted. The communication from the HCP to the implantable medical device MD may be performed using end-to-end encryption, in which case the communication is not decrypted by the P-EID 320''. In such an embodiment, the P-EID 320'' acts as a router that simply passes the encrypted communication from the HCP to the controller 300 of the implantable medical device MD. This solution further improves security by reducing the risk of unencrypted signals being intercepted by unauthorized devices, since only the HCP and the implantable medical device MD have the keys to decrypt the information.

[0503] When the implantable medical device MD is remotely controlled and / or updated by the HCP via P-EID 320''', the HCP Dedicated Device (DD) 332 displays an interface where predefined program steps or setpoints are presented to the HCP. The HCP provides input to the HCP DD 332 by selecting a program step, changing setpoints and / or values, or changing the order in which the predefined program steps are executed. Instructions / parameters entered into the HCP DD 332 for remote operation are routed to the P-EID 320''' via the DDI 330 which may or may not be able to decrypt / read the instructions in the embodiment shown in FIG. 17. The DDI 330 may store the instructions for a period of time in order to later forward the instructions in a created package of instructions to the P-EID 320'''. An additional layer of encryption may also be provided to the package by the DDI 330. The additional layer of encryption may be an encryption layer that is decrypted by the P-EID 330 or may be an encryption layer that can only be decrypted by the controller 300 of the implantable medical device MD, thereby reducing the risk of unencrypted instructions or packages being intercepted by unauthorized devices. The instructions / parameters are then provided to the P-EID 320'', which loads the instructions / parameters into the implantable medical device MD during the next charge / energy transfer using any of the signal transfer means (wireless or conductive) disclosed herein.

[0504] The Health Care Professional EID (HCP EID) 320' has the same functionality as the P-EID 320'' and can communicate with the implantable medical device MD in the same alternative ways (and combinations of alternative ways) as the P-EID 320''. In addition, however, the HCP EID 320' also allows the HCP to freely reprogram the controller 300 of the implantable medical device MD, including replacing the entire program code running on the controller 300. The idea is that the HCP EID 320' is always in the hands of the HCP, so any updates to program code or retrieval of data from the implantable medical device MD using the HCP EID 320' are performed in the presence (i.e., not remotely) of the HCP. The physical presence of the HCP is an additional layer of security for these updates that may be critical to the functionality of the implantable medical device MD.

[0505] In the embodiment shown in FIG. 17, the HCP communicates with the HCP EID 320′ using an HCP Dedicated Device 332 (HCP DD), which is a display device that controls the HCP EID 320′ and constitutes a control interface for communicating with the HCP EID 320′. Because the HCP EID 320′ physically resides at the HCP's clinic at all times, communications between the HCP EID 320′ and the HCP DD 332 do not need to be transmitted over the Internet. Instead, the HCP DD 332 and the HCP EID 320′ can communicate using one or more of BT, a proprietary wireless communication channel, and a wired connection. Programming changes are then transmitted directly to the implantable medical device MD via the HCP EID 320′. Entering into the HCP DD 332 for direct operation by the HCP EID 320′ is the same as entering directly into the HCP EID 320′, and the HCP EID 320′ forwards the instructions directly to the implantable medical device MD.

[0506] In the embodiment shown in Figure 17, both the patient and the HCP have a combined hardware key 333', 333''. The combined key 333', 333'' consists of hardware components: a unique circuit (providing the highest level of security), a wireless NFC transmitter 339 for transmitting a specific code (providing a medium level of security), and a printed QR code 344 for optical recognition of the card (providing the lowest level of security).

[0507] The patient key 333' in the embodiment shown in FIG. 17 is in the form of a key card having an interface for communicating with the P-EID 320'' such that the key card can be inserted into a key card slot in the P-EID 320''. The NFC transmitter 339 and / or a printed QR code 344 can be used as a means to access the control interface 334i of the display device 334. Additionally, the display device 334 may require a pin code and / or biometric input such as face or fingerprint recognition.

[0508] The HCP's key 333'' in the embodiment shown in FIG. 17 is in the form of a key card having an interface for communicating with the HCP-EID 320' such that the key card can be inserted into a key card slot of the HCP-EID 320'. The NFC transmitter 339 and / or a printed QR code 344 can be used as a means to access the control interface of the HCP DD 332. Additionally, the HCP DD 332 may require a pin code and / or biometric input such as face or fingerprint recognition.

[0509] However, in alternative embodiments, the hardware key solution may be replaced with a two-factor authentication solution, such as a digital key combined with a PIN code or biometric input (such as facial recognition and / or fingerprint recognition).

[0510] In the embodiment shown in FIG. 17, communication over the internet is via a dedicated data infrastructure (DDI) 330 running on a cloud service. The DDI 330 handles communication between the HCP DD 332 and the P-EID 320''', between the HCP and the remote control device 320''', between the HCP and the patient's display device 334, and between the HCP and the auxiliary device 336 (tools for following up on the patient's treatment, such as a weight scale in the obesity treatment example, a blood pressure monitor in the blood pressure treatment example, etc.). In some embodiments, the HCP DD 332 also handles communication between the patient's display device 334 and the remote control device 335. In all examples, communication from the HCP to the P-EID 320'', the remote control 320'', the patient's display device 334, and the auxiliary device 336 may be performed using end-to-end encryption. In embodiments using end-to-end encryption, the communication cannot be decrypted by the DDI 330. In such an embodiment, the DDI 330 acts as a router that simply passes encrypted communications from the HCP to the various devices. This solution provides additional security because only the HCP and the device sending or receiving the communication have the keys to decrypt the information, reducing the risk of unencrypted signals being intercepted by unauthorized devices.

[0511] In addition to acting as a communication intermediary or router, the DDI 330 collects data of the implanted medical device MD, data of the treatment, and data of the patient. The data may be collected in encrypted, anonymized, or open format. The format of the data collected may depend on the sensitivity of the data or the source from which the data is collected. In the embodiment shown in FIG. 17, the DDI 330 transmits a questionnaire to the patient's display device 334. The questionnaire may consist of questions for the patient related to the patient's general health, related to the patient's lifestyle, or specifically related to the treatment provided by the implanted medical device MD (e.g., visual analog scales for measuring pain, etc.). The DDI 330 may compile and / or combine input from multiple sources and communicate such input to the HCP, who may use the information provided to create instructions for the various devices that are sent back through the DDI 330. The data collection performed by the DDI 330 may also be in the form of a log to allow back-trace of all communications between units in the system. Logging the communications ensures that all changes to the software or settings of the software, as well as the frequency and operation of the implanted medical device MD, are tracked. Tracking the communications allows the DDI 330 or HCP to track the treatment and respond if something in the communications indicates that the treatment is not delivering the intended results or if something appears to be wrong with one of the components in the system.

[0512] In the specific embodiment shown in Fig. 17, the wireless connections between the different units are as follows: the wireless connection 411 between the auxiliary device 336 and the DDI 330 is based on Wi-Fi or a mobile telecommunication system, and the wireless connection 411 between the auxiliary device 336 and the patient's display device 334 is based on BT. The wireless connection 412 between the patient's display device 334 and the DDI 330 is based on Wi-Fi or a mobile telecommunication system. The wireless connection 413 between the patient's display device 334 and the remote control device 320'' is based on BT. The wireless connection 414 between the remote control device 320'' and the implantable medical device MD is based on BT and UWB. The wireless connection 415 between the remote control device 320'' and the DDI 330 is based on Wi-Fi or a mobile telecommunication system. The wireless connection 416 between the P-EID 320''' and the implantable medical device MD is based on BT, UWB and charging signals. The wireless connection 417 between the P-EID 320''' and the DDI 330 is based on Wi-Fi or mobile telecommunication systems. The wireless connection 418 between the HCP-EID 320'' and the implantable medical device MD is based on BT, UWB and charging signals. The wireless connection 419 between the P-EID 320'' and the HCP DD 332 is based on BT. The wireless connection 420 between the HPC-EID 320' and the DDI 330 is based on Wi-Fi or mobile telecommunication systems. The wireless connection 421 between the HPC DD 332 and the DDI 330 is based on Wi-Fi or mobile telecommunication systems. The wireless connection 422 between the HCP-EID 320' and the HCP DD 332 is based on BT.

[0513] However, the wireless connection specifically described in the embodiment shown in FIG. 17 may be replaced or supplemented by a wireless connection based on radio frequency identification (RFID), near field communication (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The mobile communication method is, for example, 1G, 2G, 3G, 4G, or 5G. The wireless connection may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), quadrature amplitude modulation (QAM), etc. The wireless connection may further comprise techniques such as time division multiple access (TDMA), frequency division multiple access (FDMA), or code division multiple access (CDMA). The wireless connection may also be based on infrared (IR) communication. The wireless connection may feature radio frequencies in the high frequency band (HF), very high frequency band (VHF), ultra high frequency band (UHF), and essentially any other band applicable to electromagnetic wave communication. The wireless connection may also be based on ultrasonic communication, to give at least one example that does not rely on electromagnetic waves.

[0514] 17, wireless communication has been mainly described, but wireless communication between any of the external devices may be replaced by wired communication. Also, part or all of the wireless communication between the external device and the implantable medical device MD may be replaced by conductive communication (as further described with reference to FIGS. 16A to 16C) using a part of the human body as a conductor.

[0515] [Communication housing] As mentioned earlier in this application, communication with the medical implant needs to be reliable and secure. For this purpose, it is desirable to have a standalone device as an external remote control of the medical implant (e.g., illustrated as 320'' in FIG. 17) so that no other programs or applications are running on the same device that may interfere with or corrupt the communication to the medical implant. However, smartphones or tablets (e.g., illustrated as 334 in FIG. 17) have become part of everyday life for most people. That is, we almost always have our smartphones at hand. For this reason, it would be convenient if patients could use their smartphones to communicate directly with the medical implant without the need to carry additional standalone devices. However, due to the large number of other applications running on the smartphone, it does not meet the requirement of being a secure and reliable communication tool without interference from other communications. Therefore, it is desirable to separate the task of providing secure communication between the external device and the implant from the task of communication with the Internet and providing a familiar and intuitive user interface. For this purpose, an external device is provided that provides secure communication and tamper-proof software and hardware, and the display device allows intuitive and easy use. In the embodiment described with reference to Figures 18 to 22, a device that meets these combined needs is described in the form of a stand-alone remote control external device integrated into a housing unit 320'' that can be connected to a smartphone or other display device 334 such as a smartwatch or tablet.

[0516] FIG. 18 shows the housing unit 320″ in an elevated perspective view from the left, and FIG. 19 shows the housing unit 320″ in a plan view from the left. In the embodiment shown in FIG. 18, the housing unit 320″ has a rectangular shape with rounded edges and a height 1521 that is 1.5 times or more than its width 1522. The housing unit 320″ comprises a recess 1525 configured to receive a display device 334 in the form of a smartphone, configured to be fitted into the housing unit 320″ to mechanically and removably connect the display device 334 to the housing unit 320″. The border of the recess 1525 in the housing unit 320″ forms an edge 1528 configured to surround the display device 334 when the display device 334 is inserted into the recess 1525. In the embodiment shown in FIG. 18, the recess 1525 has a depth 1526 configured to allow the display device 334 to be fully inserted into the recess 1525. Thus, the depth 1526 of the recess 1525 exceeds the depth 1531 of the display device 334. In the embodiment shown in Figs. 18 and 19, the edge is relatively thin and has a width 1527 that is in the range of 1 / 8 to 1 / 100 of the width of the display device 334, and as such, the housing unit 320'' has a width in the range of 1.02 to 1.25 times the width 1522 of the housing unit 320''. Similarly, the housing unit 320'' has a height 1521 in the range of 1.01 to 1.25 times the height 1521 of the display device 334. In the embodiment shown in Figs. 120 to 19, the edge 1528 is configured to sandwich the display device 334, thereby mechanically securing the display device 334 within the housing unit 320''. The minimum bounding box of the housing unit 320 ″ and the display device 334 when mechanically connected is not 10% wider, 10% longer, or 100% taller than the minimum bounding box of the display device 334 .

[0517] To form a gripping fixation, the edge of the housing unit 320'' is made from an elastic material that provides tension between the edge 1528 and the display device 334, holding the display device 334 in place. The elastic material can be an elastic polymer material, or a thin sheet of elastic metal. To further secure the display device 334 within the housing unit 320'', the inner surface of the edge 1528 can optionally define a recess or protrusion (not shown) that corresponds to a recess or protrusion on the outer surface of the display device 334. The edge 1528 can also define a recessed portion to form a mechanical fixation between the housing unit 320'' and the display device 334 by a snap-lock type fastener.

[0518] In the embodiment shown in Figs. 18 and 19, the housing unit 320'' functions as a remote control for communicating with the implanted medical device, including receiving information from the implanted medical device and providing instructions and updates to the implanted medical device. The information may be information related to the status of the implanted medical device, including any functional parameters of the implanted medical device, or related to the patient's status, including any physiological parameters related to the patient's body (as further described in other sections of this disclosure). For the purpose of providing input to the implanted medical device and controlling and updating the functions of the housing unit 320'', the housing unit 320'' comprises a control interface consisting of switches in the form of control buttons 335. The control buttons 335 are configured to be used when the external device is disconnected from the display device 334. The control interface further comprises a display 1505, which is smaller and typically less sophisticated than the display of the display device 334. In an alternative embodiment, the control buttons 335 and the display 1505 are integrated into a single touch-responsive (touch screen) display on which the control buttons may be displayed. In the embodiment shown in FIGS. 18 and 19, one of the control buttons 335 is a control button for activating the implantable medical device, and another of the control buttons 335 is a control button for deactivating the implantable medical device. When the display device 334 is attached to the housing unit 320'', the control buttons 335 and the display are covered by the display device 334 and are inoperative in such a state. In the embodiment shown in FIGS. 18 and 19, the housing unit 320'' is configured to transmit information for displaying a user interface to the display device 334, and the display device 334 is configured to receive input from the patient for communication with the implantable medical device and transmit a signal based on the received input to the housing unit 320''. The input may be a command for changing an operational state of the implantable medical device. The display device 334 includes a touch screen configured to display the user interface and receive input from the patient.The display of the display device 334 may be constructed of one or more OLED or IPS LCD elements. When the display device 334 is connected to the housing unit 320'', the display device 334 is configured to display a control interface used to communicate with the housing unit 320'', i.e., provide input to the housing unit 320'' and receive information from the housing unit 320''. Input provided to the housing unit 320'' is then relayed to the implanted medical device, and similarly, information communicated from the implanted medical device to the housing unit 320'' may be relayed or displayed on the display device 334. Having an external device consisting of a combination of the housing unit 320'' constituting a communication means for communicating with the implanted medical device and the display device 334 essentially functioning only as an input / output device connected to the housing unit 320'', allows for secure communication between the housing unit 320'' and the display device 334 that is out of reach of the Internet connection of the display device 334, making it more difficult for an external attacker to access any of the critical communication parts of the housing unit 320''. Communication between the housing unit and the display device 334 is highly restricted, and the only communication permitted from the display device 334 to the housing unit 320'' is input from the patient or medical professional and authentication parameters created by an authentication application running on the display device 334. The authentication application running on the display device 334 may be a number generating authentication device or a biometric authentication device to authenticate the patient or medical professional, and the authentication parameters may be parameters derived from, for example, a facial image or a fingerprint. In the opposite direction, i.e., from the housing unit 320'' to the display device 334, communication may be restricted to only communication necessary to display information and / or a graphical user interface on the display device 334.The communication restrictions can be based, for example, on the size of the communication package or the frequency with which the communication occurs, thereby reducing the risk of an unauthorized person making multiple attempts to extract information from or transfer information to the handheld device.

[0519] In the embodiment shown with reference to Figures 18 and 19, the housing unit 320'' comprises a first communication unit providing a wireless connection 413 to the display device 334. The wireless connection 413 is based on NFC in the embodiment shown in Figures 18 and 19, but in alternative embodiments may be based on Bluetooth or any other communication path disclosed herein. The housing unit 320'' further comprises a second communication unit providing a wireless connection with the implanted medical device. The wireless communication between the housing unit 320'' and the implanted medical device is based on Bluetooth in the embodiment shown in Figures 18 and 19, but in alternative embodiments may be based on NFC or UWB or any other communication path disclosed herein.

[0520] As mentioned above, in the embodiment shown in Figs. 18 and 19, the wireless communication between the housing unit 320'' and the display device 334 is based on NFC, and the wireless communication between the housing unit 320'' and the display device 334 is based on Bluetooth. Thus, the first communication unit of the housing unit 320'' is configured to wirelessly communicate with the display device 334' using a first communication frequency, and the second communication unit of the housing unit 320'' is configured to wirelessly communicate with the implantable medical device using a second, different communication frequency. To this end, the first communication unit of the housing unit 320'' consists of a first antenna configured for NFC-based wireless communication with the display device 334, and the second communication unit consists of a second antenna configured for Bluetooth-based wireless communication with the implantable medical device. The first and second antennas may be wire-based antennas or may be substrate-based antennas. Thus, the first communication unit is configured to wirelessly communicate with the display device 334 at a first frequency, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second, different communication frequency. Also, the first communication unit of the housing unit 320' is configured to wirelessly communicate with the display device 334 using a first communication protocol (the NFC communication protocol), and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication protocol (the Bluetooth communication protocol). Because the first and second communication protocols are different, security mechanisms may be built into the electronics and / or software that allow for transfer from the first communication protocol to the second communication protocol, providing an additional layer of security.

[0521] In an alternative embodiment, the second communication unit may be configured to wirelessly communicate with the implantable medical device using electromagnetic waves at frequencies below 100 kHz, preferably below 40 kHz. Thus, the second communication unit may be configured to communicate with the implantable medical device using "very low frequency" communication (VLF). VLF signals have the ability to penetrate the titanium housing of the implant, allowing the electronics of the implantable medical device to be fully enclosed within the titanium housing. In a further embodiment, the first and second communication units may be configured to communicate via an RFID-type protocol, a WLAN-type protocol, a BLE-type protocol, a 3G / 4G / 5G-type protocol, or a GSM-type protocol.

[0522] In yet another alternative embodiment, it is contemplated that the mechanical connection between the housing unit 320'' and the display device 334 constitutes an electrical connection for forming a wire-based communication channel between the housing unit 320'' and the display device 334. The electrical connection may also be configured to transfer electrical energy from the display device 334 to the housing unit, such that the housing unit 320''' may be powered or charged by the display device 334. A wired connection is more difficult for unauthorized entities to access than an NFC-based wireless connection, making the communication between the housing unit 320'' and the display device 334 more secure.

[0523] In the embodiment shown with reference to Figures 18 and 19, the display device 334 comprises a first communication unit providing a wireless connection 413 with the housing unit 320'' based on NFC. The display device 334 further comprises a second communication unit providing a wireless connection with a further external device and / or with the Internet. The second external device may be located far away, for example in a hospital or at a medical practitioner's clinic. The wireless communication between the display device 334 and the further external device is based on WiFi in the embodiment shown in Figures 18 and 19, but in alternative embodiments it may also be based on, for example, Bluetooth.

[0524] As mentioned above, in the embodiment shown in Figs. 18 and 19, the wireless communication between the display device 334 and the housing unit 320'' is based on NFC, and the wireless communication between the display device and the further external unit is based on WiFi. Thus, the first communication unit of the display device 334 is configured for wireless communication with the housing unit 320'' using a first communication frequency, and the second communication unit of the display device 334 is configured for wireless communication with the further external device using a second, different communication frequency. For this purpose, the first communication unit of the display device 334 comprises a first antenna configured for NFC-based wireless communication with the housing unit 320'' and the second communication unit comprises a second antenna configured for WiFi-based wireless communication with the further external device. The first and second antennas may be wire-based antennas or may be substrate-based antennas. Thus, the first communication unit is configured for wireless communication with the housing unit 320'' at a first frequency, and the second communication unit is configured for wireless communication with the further external device using a second, different communication frequency. Also, the first communication unit of the display device 334 is configured to wirelessly communicate with the housing unit 320'' using a first communication protocol (the NFC communication protocol) and the second communication unit is configured to wirelessly communicate with a further external device using a second communication protocol (the WiFi communication protocol). The first and second communication protocols are different, which adds an additional layer of security since security structures may be built into the electronics and / or software that allow for transfer from the first communication protocol to the second communication protocol.

[0525] In alternative embodiments, the second communication unit of the display device 334 may be configured to communicate with a further external device by means of a WLAN type protocol, or a 3G / 4G / 5G type protocol, or a GSM type protocol.

[0526] 18 and 19, the communication range of the first communication unit of the housing unit 320'' is less than the communication range of the second communication unit of the housing unit 320', such that the communication range between the housing unit 320'' and the medical implant may be greater than the communication range between the housing unit 320'' and the display device 334. In the embodiment shown in FIGS. 18 and 19, the communication range of the first communication unit may be constrained to be less than five times the longest dimension of the minimum bounding box of the display device 334, or more precisely, less than three times the longest dimension of the minimum bounding box of the display device 334.

[0527] In the embodiment shown in FIGS. 18 and 19, communication between the housing unit 320″ and the display device 334 is only possible when the housing unit 320″ is connected to the display device 334. That is, at least one of the housing unit 320″ and the display device 334 is configured to enable communication between the housing unit 320″ and the display device 334 based on the distance between the housing unit 320″ and the display device 334. Alternatively, the housing unit 320″ and / or the display device 334 may be configured to include a sensor configured to estimate whether the housing unit 320″ is attached to the display device 334, such as a mechanically actuated switch or a photoresistive sensor that provides a sensor input when the housing unit 320″ and the display device 334 are mechanically connected to each other. A signal from the at least one sensor may then be used to allow use of a communication unit configured for communication with the display device 334.

[0528] In the embodiment shown in Figures 18 and 19, communication between the housing unit 320'' and the implantable medical device is only possible based on the distance between the housing unit 320'' and the implantable medical device. In the embodiment shown in Figures 18 and 19, the distance is preferably less than 20 times the longest dimension of the minimum bounding box of the display device, more specifically less than 10 times the longest dimension of the minimum bounding box of the display device. The distance between the housing unit 320'' and the medical implant can be measured using electromagnetic or acoustic waves. The process of measuring the distance may consist of triangulation.

[0529] In the embodiment shown in Figures 18 and 19, to enable communication between the display device 334 and the housing unit 320'', the second communication unit of the display device 334 needs to be disabled, and further, to enable communication between the housing unit 320'' and the medical implant, the second communication unit of the display device 334 needs to be disabled. Also, to enable communication between the housing unit 320'' and the medical implant, the second communication unit of the housing unit 320'' needs to be disabled.

[0530] In the embodiment shown in Figures 18 and 19, the housing unit 320'' further comprises an encryption unit configured to encrypt communications received from the display device 334 before transmitting the communications to the implantable medical device. The encryption unit may be based, for example, on one of the following algorithms: AES, Blowfish, DES, Kalyna, Serpent or Twofish. For purposes of handling communications, I / O and encryption, the housing unit 320'' comprises a processor, which may be a general purpose microprocessor and / or an instruction set processor and / or associated chipsets and / or a special purpose microprocessor such as an ASIC (Application Specific Integrated Circuit). The processor also comprises a memory for storing instructions and / or data.

[0531] 20 and 21 show an embodiment of an external unit similar to the embodiment described with reference to FIGS. 18 and 19. The difference is that in the embodiment of FIGS. 20 and 21, the housing unit 320'' does not sandwich the display device 334. Instead, the housing unit comprises two magnets 1510 for magnetically fixing the display device 334 to the housing unit 320''. In alternative embodiments, it is also conceivable that the external device is comprised of an intermediate portion that is fixedly fixed to the housing unit to provide a removable connection with the display device 334. Alternatively, the intermediate portion may be fixedly fixed to the display device 334 and provide a removable connection with the housing unit 320''.

[0532] FIG. 22 shows a system overview of an external device (which may be the external device of the embodiments described with reference to FIGS. 18 and 19 or the external device of the embodiments described with reference to FIGS. 20 and 21). A housing unit 320'' is connected to a display device 334. A wireless connection 413 is provided between the housing unit 320'' and the display device 334, and a further wireless connection 413 is provided between the housing unit 320'' and the implantable medical device MD, allowing the housing unit to send instructions and updates to the implantable medical device MD and to receive information, parameters (such as sensor values) and alarms from the implantable medical device MD. Communications between the external device and the implantable medical device MD are further described elsewhere in this disclosure.

[0533] [Surface coating] 23 shows an implantable medical device or implant MD comprising a body 510, an implant surface 520, and a coating 530 disposed on surface 520. Coating 530 may be configured to have antimicrobial properties. Depending on the application of the implantable medical device, one or both of these effects may be advantageous. Coating 530 may be disposed on surface 520 to shield surface 520 from direct contact with a host body into which the implantable medical device MD is inserted.

[0534] Coating 530 may include at least one layer of a biomaterial. Coating 530 may be comprised of an anti-thrombogenic material. Coating 530 may also be comprised of an anti-bacterial material. Coating 530 may be chemically attached to surface 520.

[0535] FIG. 24 illustrates an exemplary implantable medical device or implant MD having a body 510 and a surface 520. The implantable medical device MD comprises multiple coatings 530a, 530b, 530c disposed on the surface. The implant MD can comprise any number of coatings, and in the particular embodiment of FIG. 24, three layers of coatings 530a, 530b, 530c are disclosed. A second coating 530b is disposed on the first coating 530a. The different coatings 530a, 530b, 530c can be comprised of different materials with different characteristics to prevent either fibrin sheath formation or bacteria from collecting on the surface 520. As an example, the first coating 530a may be comprised of a layer of perfluorocarbon chemically attached to the surface. The second coating 530b may be comprised of a liquid perfluorocarbon layer disposed on the first coating 530a.

[0536] The mentioned coatings can consist of any substance or combination of substances. The coatings may include anticoagulants such as: apixaban, dabigatran, dalteparin, edoxaban, enoxaparin, fondaparinux, heparin, rivaroxaban, warfarin, etc.

[0537] The coating may also contain medicines or substances that are so-called antiplatelet agents. These include Aspirin, Cilostazol, Clopidogrel, Dipyridamole, Eptifibatide, Prasugrel, Ticagrelor, Tirofiban, Vorapaxar.

[0538] The coating may also include other types of substances that have antithrombotic, antiplatelet, and antibacterial properties, such as sortase A, perfluorocarbons, and the like.

[0539] The coating can also be combined with implantable medical devices made of certain materials that have antibacterial and antithrombotic properties. For example, certain metals exhibit antibacterial properties. If the implant or at least the outer surface of the implant is made of such a metal, it is advantageous to reduce bacterial infection. The medical implant or the surface of the implant may be made of other suitable metals or materials. For example, the surface may be composed of any of the following metals or combinations: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.

[0540] [Porous coating for medical applications] Implantable medical devices can also be coated with localized, sustained-release antifibrotic or antibacterial drugs to prevent fibrin sheath formation and bacterial inflammation. Drugs or pharmaceuticals can also be coated on the surface and positioned to be slowly released from the implant to prevent fibrin and inflammation development. Drugs can also be delivered to the body and covered with a slow-degrading porous or soluble material to prevent fibrin formation. Drugs can be conventional antifibrotic or antibacterial drugs.

[0541] [Physical structure of the implant surface] Figures 25A and 25B show different micropatterns on the implant surface. The physical structure of the implant material can be modified or controlled to improve blood compatibility. Creating a specific topography on the implant surface can inhibit fibrin production and inflammatory responses. Figure 25A shows an example of a micropattern that mimics the characteristics of sharkskin. This micropattern can come in a variety of shapes and depths into the implant surface and can complement other coatings or be used alone. Figure 25B shows another example of a micropattern.

[0542] The micropattern can be, for example, etched onto the surface of the implantable medical device prior to insertion into the body. The surface of the implantable medical device can be, for example, composed of a metal. The surface can be, for example, composed of any of the following metals or combinations of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin, or lead. These metals are advantageous in that they have proven antibacterial properties and may ensure that the implant functions better when inserted into the host's body.

[0543] [Transplantation method] FIG. 26 is a flow chart of a method for implanting at least one component of the aforementioned system, comprising the following steps: - Incision in the skin; - Freely remove at least one site in the patient's body; - disposing a housing containing at least one injection needle within said anatomical region such that a tip of the at least one injection needle penetrates a patient's tissue when penetrating an outer wall of the housing to inject a substance through said at least one penetration region via the at least one injection needle; - After implanting at least part of the system, at least the skin is closed.

[0544] The method may further include disposing one or more of the following components of the system within the patient's body separate from the housing that houses the at least one infusion needle: - at least a 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 parts 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), and - at least one tube for injecting a substance to be injected by at least one needle;

[0545] [POP Rivet Flange] 27 and 28 show...

Claims

1. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing (12) for implantation in a patient's body, the housing (12) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract said at least one injection needle (11) in opposite forward and retraction directions so that a distal end of said at least one injection needle (11) penetrates said penetration area (14) in order to be able to inject a substance via said at least one injection needle (11) through said penetration area (14), upon advancement of said at least one injection needle (11); a needle cooperating element (13; 113; 213; 713) arranged to cooperate with said at least one infusion needle (11) during advancement or retraction of said at least one infusion needle (11); Equipped with the needle cooperating member (13; 113; 213; 713) further comprises a cross guide (15; 115; 215; 715) coupled thereto so that the needle cooperating member (13; 113; 213; 713) is movable along the cross guide (15; 115; 215; 715) to different positions in displacement directions different from an advancement direction and a retreat direction, at least one linear bearing; and a translation frame arranged to move in forward and backward directions along the at least one linear bearing, the cross guide being fixed to the translation frame; system.

2. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing (12) for implantation in a patient's body, the housing (12) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract said at least one injection needle (11) in opposite forward and retraction directions so that a distal end of said at least one injection needle (11) penetrates said penetration area (14) in order to be able to inject a substance via said at least one injection needle (11) through said penetration area (14), upon advancement of said at least one injection needle (11); a needle cooperating element (13; 113; 213; 713) arranged to cooperate with said at least one infusion needle (11) during advancement or retraction of said at least one infusion needle (11); Equipped with the needle cooperating member (13; 113; 213; 713) further comprises a cross guide (15; 115; 215; 715) coupled thereto so that the needle cooperating member (13; 113; 213; 713) is movable along the cross guide (15; 115; 215; 715) to different positions in displacement directions different from an advancement direction and a retreat direction, the cross guide (15; 115; 215; 715) is fixedly held between two opposite fixing points, system.

3. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing (12) for implantation in a patient's body, the housing (12) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract said at least one injection needle (11) in opposite forward and retraction directions so that a distal end of said at least one injection needle (11) penetrates said penetration area (14) in order to be able to inject a substance via said at least one injection needle (11) through said penetration area (14), upon advancement of said at least one injection needle (11); a needle cooperating element (13; 113; 213; 713) arranged to cooperate with said at least one infusion needle (11) during advancement or retraction of said at least one infusion needle (11); Equipped with the needle cooperating member (13; 113; 213; 713) further comprises a cross guide (15; 115; 215; 715) coupled thereto so that the needle cooperating member (13; 113; 213; 713) is movable along the cross guide (15; 115; 215; 715) to different positions in displacement directions different from an advancement direction and a retreat direction, A system wherein said cross guide (15; 115; 215; 715) comprises a shaft on which said needle cooperating member (13; 113; 213; 713) is slidably mounted.

4. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing (12) for implantation in a patient's body, the housing (12) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract said at least one injection needle (11) in opposite forward and retraction directions so that a distal end of said at least one injection needle (11) penetrates said penetration area (14) in order to be able to inject a substance via said at least one injection needle (11) through said penetration area (14), upon advancement of said at least one injection needle (11); a needle cooperating element (13; 113; 213; 713) arranged to cooperate with said at least one infusion needle (11) during advancement or retraction of said at least one infusion needle (11); Equipped with the needle cooperating member (13; 113; 213; 713) further comprises a cross guide (15; 115; 215; 715) coupled thereto so that the needle cooperating member (13; 113; 213; 713) is movable along the cross guide (15; 115; 215; 715) to different positions in displacement directions different from an advancement direction and a retreat direction, a translation frame (103; 203; 703) arranged to move in a forward and backward direction, said cross guide (15; 115; 215; 715) being fixed to the translation frame (103; 203; 703) for movement therewith; system.

5. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing (12) for implantation in a patient's body, the housing (12) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract said at least one injection needle (11) in opposite forward and retraction directions so that a distal end of said at least one injection needle (11) penetrates said penetration area (14) in order to be able to inject a substance via said at least one injection needle (11) through said penetration area (14), upon advancement of said at least one injection needle (11); a needle cooperating element (13; 113; 213; 713) arranged to cooperate with said at least one infusion needle (11) during advancement or retraction of said at least one infusion needle (11); Equipped with the needle cooperating member (13; 113; 213; 713) further comprises a cross guide (15; 115; 215; 715) coupled thereto so that the needle cooperating member (13; 113; 213; 713) is movable along the cross guide (15; 115; 215; 715) to different positions in displacement directions different from an advancement direction and a retreat direction, said at least one infusion needle (11) constituting an array (705) of infusion needles (11), said needle cooperating member (713) being arranged to cooperate with each one infusion needle (11) of the array (705) of infusion needles (11) at a time; system.

6. 1. An at least partially implantable system for injecting a substance into a patient's body, comprising: a housing (12) for implantation in a patient's body, the housing (12) having an outer wall with a penetration area (14); at least one injection needle (11) arranged in said housing (12); a drive unit (D; 100; 200; 700) arranged to advance and retract said at least one injection needle (11) in opposite forward and retraction directions so that a distal end of said at least one injection needle (11) penetrates said penetration area (14) in order to be able to inject a substance via said at least one injection needle (11) through said penetration area (14), upon advancement of said at least one injection needle (11); a needle cooperating element (13; 113; 213; 713) arranged to cooperate with said at least one infusion needle (11) during advancement or retraction of said at least one infusion needle (11); Equipped with the needle cooperating member (13; 113; 213; 713) further comprises a cross guide (15; 115; 215; 715) coupled thereto so that the needle cooperating member (13; 113; 213; 713) is movable along the cross guide (15; 115; 215; 715) to different positions in displacement directions different from an advancement direction and a retreat direction, a displacement cable (120; 720) or a displacement belt for pulling the needle cooperating member (113; 713) in a displacement direction along the cross guide (115; 715), system.

7. The drive unit (D; 100; 700) a first motor for moving said at least one injection needle (11) in a reverse direction or both; a second motor for displacing said needle cooperating member (13; 113; 713) in a displacement direction; The system according to any one of claims 1 to 6, comprising:

8. 7. The system according to claim 1, wherein the cross guide (15; 115; 215; 715) extends in a displacement direction perpendicular to the direction of advancement and retraction of the at least one infusion needle (11) or in a direction oblique to the direction of advancement and retraction of the at least one infusion needle (11).

9. 6. The system according to claim 5, wherein the needle cooperating members (713) are arranged to act on the array (705) of infusion needles (11) so as to advance or retract each one of the infusion needles (11) depending on its position relative to the cross guide (715).

10. 10. The system according to claim 9, wherein the needle cooperating member (713) is separate from the array (705) of injection needles (11).

11. 11. The system of claim 10, wherein in a rest position the needle cooperating members (713) are disengaged from the array (705) of infusion needles (11) and engage with each one of the infusion needles (11) upon movement of the translation frame (703).

12. 10. The system of claim 9, wherein the infusion needles (11) of the array (705) of infusion needles (11) are mounted in a mounting block (706) so as to be slidable in an advancing and retreating direction.

13. 13. The system according to claim 12, wherein the needle cooperating members (713) are arranged to advance each one of the infusion needles (11) by pushing it in an advancing direction.

14. 6. The system of claim 5, wherein the needle cooperating member (713) comprises a needle driving portion (713B) and a positioning portion (713A), the needle driving portion (713B) and the positioning portion (713A) being arranged to disengage from each other when the translation frame (703) moves in an advancement direction.

15. 15. The system of claim 14, further comprising a secondary cross guide member (715A) arranged parallel to the cross guide (715), wherein the positioning portion (713A) is movably, preferably slidably, mounted on the secondary cross guide member (715A), and the needle drive portion (713B) is movably, preferably slidably, mounted on the cross guide (715).

16. 16. The system of claim 15, wherein when the positioning portion (713A) and the needle driving portion (713B) are engaged, the positioning portion (713A) is movable in a displacement direction along the cross guide (715), thereby allowing the needle driving portion (713B) to be moved to a desired position along the secondary cross guide member (715A) in the displacement direction as well, and when the positioning portion (713A) is moved in an advancing / retreating direction, the engagement between the needle driving portion (713B) and the positioning portion (713A) is released.

17. 15. The system according to claim 14, wherein a displacement cable (120; 720) for pulling the needle cooperating member (713) in a displacement direction along the cross guide (715) is connected to the positioning portion (713A) of the needle cooperating member (713).

18. 7. The system according to claim 1, wherein the at least one infusion needle (11) consists of a single infusion needle (11), the single infusion needle (11) being attached to the needle cooperating element (113; 213) so as to be movable in the displacement direction together with the needle cooperating element (113; 213).

19. 19. The system according to claim 18, wherein the single injection needle (11) is welded or potted to the needle cooperating member (113; 213).

20. 19. The system according to claim 18, wherein the single injection needle (11) has a curved portion, the curved portion being attached to the needle cooperating element (113; 213).

21. 21. The system according to claim 20, wherein said curved portion is fixedly held in a corresponding curved recess (114) of said needle cooperating member (113; 213).

22. 19. The system according to claim 18, wherein a needle stiffening tube (20) is arranged around the single injection needle (11).

23. 19. The system according to claim 18, further comprising a tube for supplying a substance to the single injection needle (11), the tube being connected to an end of the single injection needle (11) and looped within the housing (12) to allow the required range of movement of the tube.

24. 7. The system of claim 6, comprising a tension spring (709) providing a force counteracting the tension of the displacement cable (720) acting on the needle cooperating member (713).

25. 25. The system of claim 24, wherein the reaction force provided by the tension spring (709) is strong enough to move the needle cooperating member (713) in a direction opposite to the displacement direction in the absence of a tension force of the displacement cable (720) acting on the needle cooperating member (713).

26. 25. The system of claim 24, wherein the extension spring (709) is a constant force extension spring.

27. 25. The system of claim 24, wherein the tension spring (709) comprises a metal band that winds on itself when no tension is applied, one end of the metal band being attached to a reel and the other end of the metal band being connected to the needle cooperating member (713).

28. 25. The system of claim 24, wherein the tension spring provides a tension force of (a) between 0.5 N and 2 N, or (b) between 0.8 N and 1.2 N, or (c) approximately 1 N.

29. 7. The system of claim 6, wherein the displacement cable (120) or the displacement belt (114) is arranged to pull the needle cooperating member (113) along the cross guide (115) in opposite first and second displacement directions.

30. 30. The system of claim 29, comprising a first wheel (121) having a first axis of rotation and a second wheel (122) having a second axis of rotation parallel to and spaced apart from the first axis of rotation, the displacement cable (120) or the displacement belt winding around the first and second wheels (121, 122).

31. 31. The system of claim 30, wherein the displacement cable (120) or the displacement belt is endless.

32. 32. The system of claim 31, wherein the displacement cable (120) or the displacement belt extends from a first wheel (121) to a second wheel (122), wraps around the second wheel (122) by at least 180°, and returns from the second wheel (122) to the first wheel (121) and forms a loop that wraps around the first wheel (121) by at least 180°.

33. 33. The system of claim 32, wherein the displacement cable (120) or the displacement belt wraps 180[deg.] and / or a full number of revolutions around at least one of the first and second wheels (121, 122).

34. 31. The system of claim 30, further comprising a tensioning element (123) for generating tension in the displacement cable (120) or the displacement belt in a direction transverse to a longitudinal axis of the displacement cable (120) or the displacement belt.

35. 35. The system of claim 34, wherein a drive cable (124) is arranged to rotate the first or second wheels (121, 122) and extends from the housing (12).

36. 36. The system of claim 35, wherein the drive cable (124) is connected to one of the first and second wheels (121, 122) and is arranged to wrap around or around the first or second wheel (121, 122).

37. 36. The system of claim 35, wherein at least one of the first and second wheels (121, 122) is attached to the drive shaft so as to rotate with rotation of the drive shaft, and the drive cable (124) is connected to the drive shaft to drive the drive shaft.

38. 38. The system of claim 37, further comprising a third wheel (126) attached to the drive shaft, the drive cable (124) winding on and off the third wheel (126) or around the third wheel (126).

39. When the drive cable (124) is arranged to wrap around or separate from the first or second wheel (121, 122) or the third wheel (126), The drive cable (124) 36. The system of claim 35, wherein one end of the drive cable (124) is attached to a respective first, second or third wheel (121, 122, 126) such that when the drive cable (124) is pulled in a first direction, the drive cable (124) unwinds and a portion of the drive cable (124) moves out of the housing (12), and a tension spring is arranged to pull the drive cable (124) in an opposite second direction to return the drive cable (124) to the respective first, second or third wheel (121, 122, 126) into the housing (12).

40. 36. The system of claim 35, wherein the drive cable (124) is arranged so that when the drive cable (124) is arranged to wrap around the first or second wheel (121, 122) or around the third wheel (126), when the drive cable (124) is pulled, a portion of the drive cable (124) moves into the housing (12) while another portion of the drive cable (124) moves out of the housing (12).

41. 7. The system according to claim 1, further comprising a first alignment structure arranged on the needle cooperating member (713) and a second alignment structure arranged in a fixed manner, wherein the first and second alignment structures engage with each other and define different rest positions for the needle cooperating member (713) when the needle cooperating member (713) is moved to different positions along the cross guide (715).

42. 42. The system of claim 41, wherein the first alignment structure is a leaf spring (711) and the second alignment structure is comprised of a plurality of stationary detents or protrusions (310) arranged to cooperate with the leaf spring (311), or the first alignment structure is comprised of a plurality of detents or protrusions and the second alignment structure is comprised of one or more stationary leaf springs arranged to cooperate with the detents or protrusions.

43. The system of claim 1 , wherein the at least one linear bearing comprises two parallel linear bearings.

44. 44. The system of claim 43, comprising at least one return spring arranged to bias the translating frame to a rest position.

45. 45. The system of claim 44, wherein the at least one return spring comprises a coil spring disposed around one of the at least one linear bearing or two coil springs disposed around each of two parallel linear bearings.

46. 7. The system of claim 1, wherein the drive unit comprises an advancement cable arranged to advance or retract the at least one infusion needle by pulling on the advancement cable.

47. 7. The system according to claim 1, wherein the drive unit comprises a combined advancement and displacement cable arranged to enable both causing advancement or retraction of the at least one infusion needle and causing displacement of the at least one infusion needle in a displacement direction different from the advancement and retraction direction by pulling the advancement and displacement cable.

48. 7. The system of claim 1, wherein the at least one injection needle comprises a tubular needle body having a distal end, an injection port disposed at the distal end so that a substance can be injected through the at least one injection needle, a supply port disposed at a position remote from the distal end so that the substance to be injected can 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 disposed on a side of the tubular needle body.

49. 7. The system of claim 1, further comprising an injection port provided on the side of the at least one injection needle, the injection port being spaced less than 2 mm from the tip of the at least one injection needle.

50. an injection port is provided in the side of said at least one injection needle; 7. The system according to claim 1, wherein when the at least one infusion needle is in the retracted position, the tip of the at least one infusion needle is located within a 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 infiltration of fluid through the tube into the injection port.

51. 51. The system of claim 50, wherein the inner diameter of the inner surface of the tube and the outer diameter of the outer surface of the at least one injection needle match each other to form a fluid-tight seal to prevent fluid infiltration through the tube and into the injection port.

52. 52. The system of claim 51, wherein 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. 7. The system according to claim 1, wherein the penetration area is at least partially made of an elastic material, the elastic material having a pre-formed passage for the at least one injection needle to pass through, the passage being normally closed by an elastic force generated by the elasticity of the elastic material.

54. 54. The system of claim 53, wherein the tip of the at least one infusion needle resides inside the passage when the infusion needle is in the retracted position.

55. 54. The system of claim 53, wherein the passageway is configured with a lengthwise extending slit and a widthwise extending slit.

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