Devices and methods for achieving bladder control

Abstract

The present disclosure relates to techniques for restricting the bladder and for draining urine from the bladder. More specifically, an implantable pump device is provided having one or more constriction devices configured to constrict the bladder to drain urine.

Description

Technical Field

[0001] The present invention relates to an implantable device for achieving urinary control and bladder emptying, thereby preventing or treating involuntary urinary retention. More particularly, the present invention relates to an implantable device for discharging urine from the bladder using a power member that operates from outside the bladder assisted by a support structure.

Background Art

[0002] Urinary dysfunction is generally caused by spinal cord injury with involuntary urinary retention. This condition is associated with urinary tract infections, kidney disorders, and urinary tract injuries. A common treatment for urinary retention is continuous or intermittent catheterization. Catheters are not only inconvenient for patients but also always pose a risk of causing infections.

Summary of the Invention

[0003] According to one aspect, there is provided an implantable pump device for discharging urine from a patient's bladder. The implantable pump device includes a first constriction device configured to constrict a part of the bladder to close a first portion of the bladder. The implantable pump device further includes a second constriction device configured to constrict a second portion of the bladder downstream of the first portion to discharge urine from the bladder when the first portion of the bladder is closed. The implantable pump device further includes a control device configured to control the first and second constriction devices.

[0004] According to one embodiment, an implantable pump device is provided for draining urine from a patient's bladder (U). The implantable pump device comprises a rotor carrying a stricture device. The stricture device comprises a first stricture element, a second stricture element, and a third stricture element. The stricture elements are positioned equidistant from the rotor's axis of rotation. The implantable pump device further comprises a support element spaced apart from the rotor. The implantable pump device is applied to the bladder such that the bladder extends between the support element and the rotor. The implantable pump device further comprises a control device configured to control the rotor so that the stricture elements successively narrow a series of selected portions of the bladder in order to drain urine from the bladder.

[0005] According to one embodiment, an implantable pump device is provided for draining urine from a patient's bladder. The implantable pump device comprises an operable first hydraulic constriction element configured to inflate to narrow the bladder in order to restrict the flow of fluid through it. The implantable pump device further comprises a second operable hydraulic constriction element configured to narrow the bladder in order to restrict the flow of fluid through it and to inflate to drain urine from the bladder. The implantable pump device further comprises interconnecting fluid conduits that fluidly connect the first operable hydraulic constriction element to the second operable hydraulic constriction element. A first operable hydraulic stenosis element is configured to be positioned in a first part of the bladder to restrict the flow of fluid through it, thereby narrowing a first part of the urinary tract; a second operable hydraulic stenosis element is configured to be positioned in a second part of the bladder downstream of the first part to restrict the flow of fluid through it, thereby narrowing a second part of the bladder and for the discharge of urine from the bladder; a communicating fluid conduit is configured to conduct fluid from the first operable hydraulic stenosis element to the second operable hydraulic stenosis element when the pressure in the first operable hydraulic stenosis element increases, thereby further narrowing the second part of the bladder.

[0006] According to one embodiment, an implantable pump device is provided for draining urine from a patient's bladder. The implantable pump device comprises a first implantable stenosis device for narrowing the bladder. The first implantable stenosis device comprises a first operable hydraulic stenosis element configured to be inflated and thereby expand in a first direction toward the bladder to narrow a first portion of the bladder in order to restrict the flow of fluid through therein. The first implantable stenosis device further comprises a support operable hydraulic stenosis element configured to support the first operable hydraulic stenosis element when it is inflated and thereby expand in a first direction toward the bladder to narrow a first portion of the bladder in order to restrict the flow of fluid through therein. The implantable pump device further comprises a second implantable stenosis device similar to the first implantable stenosis device. The second implantable stenosis device is configured to narrow a second portion of the bladder downstream of the first portion in order to drain urine from the bladder. The second portion extends a longer distance along the axial direction than the first portion.

[0007] According to one embodiment, an implantable pump device is provided for draining urine from a patient's bladder. The implantable pump device comprises a first stricture device for narrowing the bladder. The first stricture device comprises a first operable hydraulic stricture element configured to expand to exert pressure on the bladder in a first direction in order to narrow a first portion of the bladder in order to restrict the flow of fluid through therein. The first stricture device further comprises a second operable hydraulic stricture element configured to expand to exert pressure on the bladder in a second direction in order to narrow a first portion of the bladder in order to restrict the flow of fluid through therein. The first stricture device further comprises a first hydraulic system in fluid communication with the first operable hydraulic stricture element. The first stricture device further comprises a second hydraulic system in fluid communication with the second operable hydraulic stricture element. The first and second operable hydraulic stricture elements are adjustable independently of each other. The implantable pump device further comprises a second stenosis device for narrowing the bladder and draining urine from the bladder. The second stenosis device comprises a third operable hydraulic stenosis element configured to expand to exert pressure on the bladder in a first direction in order to restrict the flow of fluid through it and to narrow a second portion of the bladder for draining urine from the bladder. The second stenosis device further comprises a fourth operable hydraulic stenosis element configured to expand to exert pressure on the bladder in a second direction in order to restrict the flow of fluid through it and to narrow a second portion of the bladder for draining urine from the bladder. The second stenosis device further comprises a third hydraulic system in fluid communication with the third operable hydraulic stenosis element. The second stenosis device further comprises a fourth hydraulic system in fluid communication with the fourth operable hydraulic stenosis element. The third and fourth operable hydraulic stenosis elements are independently adjustable.

[0008] According to one embodiment, an implantable pump device is provided for draining urine from a patient's bladder. The implantable pump device comprises a first stenosis device for narrowing the bladder. The first stenosis device comprises an operable hydraulic stenosis element configured to expand to apply pressure to the bladder. The first stenosis device further comprises a first hydraulic reservoir for holding a hydraulic fluid. The first stenosis device further comprises a first hydraulic pump for pumping the fluid from the first hydraulic reservoir to the first operable hydraulic stenosis element. The first stenosis device further comprises a first fluid conduit forming a fluid connection between the first hydraulic reservoir and the first hydraulic pump. The implantable pump device further comprises a second stenosis device for narrowing the bladder downstream of the first stenosis device to drain urine from the bladder. The second stenosis device comprises a second operable hydraulic stenosis element configured to expand to apply pressure to the bladder. The second stenosis device further comprises a second hydraulic reservoir for holding a hydraulic fluid. The second stenosis device further comprises a second hydraulic pump for pumping the fluid from the second hydraulic reservoir to a second operable hydraulic stenosis element. The second stenosis device further comprises a second fluid conduit forming a fluid connection between the second hydraulic reservoir and the second hydraulic pump. The implantable pump device further comprises an electrode arrangement configured to be positioned between at least one of the first stenosis device, the second stenosis device, and the bladder. The electrode arrangement is configured to engage with and electrically stimulate the muscular tissue of the bladder, causing the muscular tissue to move and improving the long-term implantation conditions of the implantable pump device.

[0009] According to one embodiment, an implantable pumping device is provided for draining urine from a patient's bladder. The implantable pumping device comprises a first stricture device for narrowing the bladder to restrict the flow of fluid therethrough. The first stricture device comprises a first operable hydraulic stricture element configured to expand to apply pressure to the bladder. The first stricture device further comprises a second operable hydraulic stricture element configured to expand to apply pressure to the bladder. The first stricture device further comprises a first hydraulic pump for pumping fluid to the operable hydraulic stricture element. The first stricture device further comprises a second hydraulic pump for pumping fluid to the operable hydraulic stricture element. The first stricture device further comprises a motor. The motor is mechanically connected to the first and second hydraulic pumps to propel the first and second hydraulic pumps. The implantable pumping device further comprises a second stricture device downstream of the first stricture device for narrowing the bladder. The second stricture device is configured to drain urine from the bladder. The second stricture device is similar to the first stricture device.

[0010] According to one embodiment, an implantable pumping device is provided for draining urine from a patient's bladder. The implantable pumping device comprises a first stenosis device for narrowing the bladder to restrict the flow of fluid therethrough. The first stenosis device comprises a first operable hydraulic stenosis element configured to expand to apply pressure to the bladder. The first stenosis device further comprises a first hydraulic pump for pumping hydraulic fluid to the first operable hydraulic stenosis element. Downstream of the first stenosis device, the implantable pumping device further comprises a second stenosis device for narrowing the bladder to drain urine from the bladder. The second stenosis device comprises a second operable hydraulic stenosis element configured to expand to apply pressure to the bladder. The second stenosis device further comprises a second hydraulic pump for pumping hydraulic fluid to the second operable hydraulic stenosis element. The implantable pumping device further comprises an implantable energy storage unit. The implantable pumping system is connected to an implantable energy storage unit and further comprises a capacitor connected to at least one of the first and second hydraulic pumps. The capacitor is charged by the implantable energy storage unit and is configured to supply power to at least one of the first and second hydraulic pumps.

[0011] According to one embodiment, an implantable pumping device is provided for draining urine from a patient's bladder. The implantable pumping device comprises a first stricture device for narrowing the bladder to restrict the flow of fluid through it. The implantable stricture device comprises a first operable hydraulic stricture element configured to inflate to apply pressure to the bladder. The first stricture device further comprises a first hydraulic pump for pumping hydraulic fluid to the first operable hydraulic stricture element. The implantable pumping device further comprises a second stricture device configured to narrow the bladder downstream of the first stricture device for draining urine from the bladder. The second stricture device comprises a second operable hydraulic stricture element configured to inflate to apply pressure to the bladder. The second stricture device comprises a second hydraulic pump for pumping hydraulic fluid to the second operable hydraulic stricture element. The implantable pumping device further comprises a control device configured to control the first and second hydraulic pumps. The control unit comprises a sensor adapted to detect a magnetic field and a processing unit having a sleep mode and an active mode. The implantable pump device further comprises an external control unit adapted to be located outside the patient's body. The external control unit comprises a first coil adapted to form a magnetic field detectable by the internal sensor. The control unit is further configured to set the processing unit to active mode in response to the detected magnetic field exceeding a predetermined value.

[0012] According to one embodiment, a method for implanting an implantable pump device is provided. The method includes the steps of: making an incision in the patient's body to access the bladder; dissecting a portion of the bladder; inserting an implantable pump device into the patient's body; and positioning the implantable pump device in communication with the bladder so that it narrows the bladder and restricts the flow of fluid through it, thereby allowing urine to be drained from the bladder.

[0013] According to one embodiment, a method is provided in an implantable control device for controlling an implantable pump device for narrowing the bladder and draining urine from the bladder. The method includes releasing pressure in first and second implantable hydraulic stricture elements so that there is substantially no pressure on the bladder. The method further includes measuring the pressure in the first and / or second implantable hydraulic stricture elements when there is substantially no pressure on the bladder. The method further includes increasing the pressure in the first implantable hydraulic stricture element to a specified level. The method further includes increasing the pressure in the second implantable hydraulic stricture element to a second specified level.

[0014] According to one embodiment, a control device is provided for controlling the pressure in an implantable pump device for narrowing the bladder and draining urine from the bladder. The control device comprises a pressure sensor for measuring the pressure in a first and / or second implantable hydraulic stricture element. The control device further comprises a calculation unit. The calculation unit is configured to create an absolute pressure by subtracting the pressure in the first and / or second implantable hydraulic stricture element when there is substantially no pressure on the bladder from the pressure in the hydraulic stricture element when the pressure in the first and / or second implantable hydraulic stricture element increases.

[0015] According to one embodiment, an implantable pump device is provided for draining urine from a patient's bladder. The implantable pump device comprises a first stricture device configured to narrow a portion of the bladder to close a first portion of the bladder. The implantable pump device further comprises a second stricture device configured to narrow a second portion of the bladder downstream of the first portion to drain urine from the bladder when the first portion of the bladder is closed. The implantable pump device further comprises a control device configured to control the first and second stricture devices. The implantable pump device further comprises a coating disposed on at least one surface of at least one of the first or second stricture devices.

[0016] According to one embodiment, a medical device for draining urine from a patient's bladder is provided, configured to be held in place by a tissue portion of the patient. The medical device comprises an implantable pump device for draining urine from a patient's bladder. The implantable pump device comprises a first stenosis device configured to narrow a portion of the bladder to close a first portion of the bladder. The implantable pump device further comprises a second stenosis device configured to narrow a second portion of the bladder downstream of the first portion to drain urine from the bladder when the first portion of the bladder is closed. The medical device further comprises an implantable electroconductive medical device configured to be held in place by a tissue portion of the patient. The implantable electroconductive medical device comprises a first portion configured to be positioned on a first side of a tissue portion, the first portion comprising a first surface having a first cross-sectional area in a first plane and configured to face a first tissue surface on the first side of the tissue portion. An implantable electromedical device further comprises a second portion configured to be positioned on a second side of a tissue portion, the second side facing the first side, and the second portion having a second cross-sectional area in a second plane and a second surface configured to engage with a second tissue surface on the second side of the tissue portion. The implantable electromedical device further comprises a connecting portion configured to be positioned through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a fourth cross-sectional area in a fourth plane and a third surface configured to engage with a first tissue surface on the first side of the tissue portion. The connecting portion is configured to connect the first portion to the second portion. The first, second, third and fourth planes are parallel to each other. The third cross-sectional area is smaller than the first, second, and fourth cross-sectional areas, so as to prevent the first portion, the second portion, and the connecting portion from moving through the holes in the tissue portion in directions perpendicular to the first, second, and third planes. The first portion is detachably connected to at least one of the connecting portion and the second portion. The second portion is configured to connect in the trunk direction to an implantable pumping device.

[0017] The following describes a system that influences the effector response of a patient. In such a system, the first and second effector tissues may be selected from a group consisting of the urinary bladder and the urinary sphincter, and the first and second stimulus signals cause contraction of the urinary bladder to empty it and / or relaxation of the urinary sphincter to allow urine to pass from the urinary bladder through the urethra.

[0018] In some embodiments, the effector tissue is one or more of the group consisting of the urinary bladder and the urinary sphincter, and stimulation and / or inhibition of the effector response is configured to promote contraction of the urinary bladder to empty it and / or relaxation of the urinary sphincter to allow urine to pass from the urinary bladder through the urethra.

[0019] According to one embodiment, a system is provided for influencing a patient's effector response. The system comprises a stimulator configured to directly or indirectly deliver a first stimulus signal to a sympathetic nerve innervating a first effector tissue of the patient, and a second stimulus signal to a parasympathetic nerve innervating a second effector tissue. The system further comprises a control unit configured to control the operation of the stimulator such that the first stimulus signal stimulates sympathetic nerve activity and the second stimulus signal suppresses parasympathetic nerve activity, or the first stimulus signal suppresses sympathetic nerve activity and the second stimulus signal stimulates parasympathetic nerve activity.

[0020] In some embodiments, the control unit may be configured to control the operation of the stimulator such that at least one of the first stimulus signal and the second stimulus signal is a periodic signal including at least one of a variable frequency component, a variable duty cycle component, a variable amplitude component, and a variable pause component.

[0021] In some embodiments, the first signal may be a low-frequency signal configured to stimulate sympathetic nerve activity, and the second signal may be a high-frequency signal configured to suppress parasympathetic nerve activity. Alternatively, the first signal may be a high-frequency signal configured to suppress sympathetic nerve activity, and the second signal may be a low-frequency signal configured to stimulate parasympathetic nerve activity.

[0022] In some embodiments, the amplitude of the low-frequency signal varies at a frequency in the range of 0.1 to 100 Hz, and the amplitude of the high-frequency signal varies at a frequency in the range of 1 to 10 kHz.

[0023] In some embodiments, at least one of the first and second stimulation signals may be composed of a series of pulses having a negative voltage with respect to ground.

[0024] In some embodiments, the control unit may be configured to operate the stimulation device to generate a positive voltage pulse following one or more negative voltage pulses.

[0025] In some embodiments, at least one of the first stimulation signal and the second stimulation signal may be an electrical signal or a vibration signal.

[0026] In some embodiments, the control unit may be configured to operate the stimulation device to alternately apply the first stimulation signal to the sympathetic nerve and the second stimulation signal to the parasympathetic nerve.

[0027] In some embodiments, the control unit may be configured to operate the stimulation device to simultaneously apply the first stimulation signal to the sympathetic nerve and the second stimulation signal to the parasympathetic nerve.

[0028] In some embodiments, the control unit may be configured to control the operation of the stimulation device to generate an effector reaction that is at least one of a muscle reaction and a gland reaction.

[0029] In some embodiments, each of the first and second effector tissues may be muscle tissue. Further, the control unit may be configured to control the operation of the stimulation device such that the first stimulation signal stimulates the activity of the sympathetic nerve, the second stimulation signal suppresses the activity of the parasympathetic nerve, thereby inducing contraction in the muscle tissue.

[0030] In some embodiments, each of the first and second effector tissues may be muscle tissue. Further, the control unit may be configured to control the operation of the stimulation device such that the first stimulation signal suppresses the activity of the sympathetic nerve, the second stimulation signal stimulates the activity of the parasympathetic nerve, thereby inducing relaxation in the muscle tissue.

[0031] In some embodiments, the first and second effector tissues may be smooth muscle tissue.

[0032] In some embodiments, the first and second effector tissues may form part of the patient's blood vessels, intestines, or urinary bladder.

[0033] In some embodiments, the system may further include a sensor device configured to generate a sensor signal indicative of an effector response in the effector tissue, and a control unit configured to receive the sensor signal and control the operation of the stimulation device based at least in part on the sensor signal.

[0034] In some embodiments, the sensor device may include sensor electrodes configured to measure the electrical activity in the effector tissue.

[0035] In some embodiments, the sensor device may include sensor electrodes configured to measure changes in the electrical impedance in the effector tissue.

[0036] In some embodiments, the sensor device may include an electromyograph sensor configured to measure electrical activity in effector tissue and an electrical impedance sensor configured to measure changes in electrical impedance in effector tissue.

[0037] In some embodiments, the sensor electrode may be configured to be placed in the effector tissue. The sensor may further include a reference electrode and may be configured to generate a sensor signal based on the electrical interaction between the sensor electrode and the reference electrode.

[0038] In some embodiments, the reference electrode may be formed by the housing of a stimulating device or a sensor device.

[0039] In some embodiments, the sensor device may be configured to measure the mechanical movement of the effector tissue.

[0040] In some embodiments, the sensor device may include a strain gauge configured to measure contraction or relaxation of effector tissue.

[0041] In some embodiments, the control unit may be configured to determine a response scale based on a sensor signal, the response scale representing the effector response.

[0042] In some embodiments, the control unit may be configured to compare a response scale to a predetermined reference scale and, in response to the response scale being less than or equal to the reference scale, to control the stimulator to increase the intensity of a first stimulus signal to stimulate sympathetic nervous system activity and / or increase the intensity of a second stimulus signal to suppress parasympathetic nervous system activity. Furthermore, the control unit may be configured to control the stimulator to decrease the intensity of a first stimulus signal to suppress sympathetic nervous system activity and / or decrease the intensity of a second stimulus signal to stimulate parasympathetic nervous system activity in response to the response scale being greater than the reference scale. The predetermined reference scale may be based on previous measurements of effector responses in a patient or in another patient.

[0043] In some embodiments, the control unit may be configured to monitor the response scale of the effector response over time and to control the stimulator based on the rate of change of the effector response over time.

[0044] In some embodiments, the control unit may be configured to determine the calibration parameters of the stimulator based on a response scale.

[0045] In some embodiments, the stimulator may include a first electrode arrangement configured to be coupled to the sympathetic nerves to deliver a first stimulatory signal, and a second electrode arrangement configured to be coupled to the parasympathetic nerves to deliver a second stimulatory signal.

[0046] In some embodiments, the first electrode arrangement may include a first stimulating electrode and a second stimulating electrode, which may be configured to be spaced apart along the sympathetic nerve.

[0047] In some embodiments, the stimulator may be configured to generate a first stimulation signal such that a first stimulation electrode functions as a cathode and a second stimulation electrode functions as an anode.

[0048] In some embodiments, the system may further include a cuff that is at least partially positioned around the nerve and configured to hold the first electrode placement in place relative to the sympathetic nerve.

[0049] In some embodiments, the second electrode arrangement may include a third electrode and a fourth electrode, the third and fourth electrodes being configured to be spaced apart along the parasympathetic nerve. The second electrode arrangement may further include a fifth electrode configured to be spaced apart from the fourth electrode, such that the fourth electrode is positioned between the third and fifth electrodes.

[0050] In some embodiments, the stimulator may be configured to generate a second stimulation signal such that the fourth electrode functions as the cathode and the third and fifth electrodes function as the anodes.

[0051] In some embodiments, the system may further include a cuff positioned at least partially around the parasympathetic nerve and configured to hold a second electrode placement in a predetermined position relative to the parasympathetic nerve.

[0052] According to one embodiment, a system is provided that influences a patient's effector response, comprising a stimulator configured to be coupled to at least one of the patient's effector tissue and the nerves innervating the effector tissue, and a control unit configured to operate the stimulator to apply at least one of a first stimulus signal and a second stimulus signal to the effector tissue. The first stimulus signal is a time-varying signal whose amplitude changes at frequencies in a first frequency interval, and the second stimulus signal is a time-varying signal whose amplitude changes at frequencies in a second frequency interval. The first frequency interval is selected to induce an effector response in the effector tissue, and the second frequency interval is selected to suppress an effector response in the effector tissue.

[0053] In some embodiments, the first frequency interval is 0.1 to 100 Hz, and the second frequency interval is 1 to 10 kHz.

[0054] In some embodiments, at least one of the first and second stimulus signals may be an electrical signal consisting of a series of pulses having a negative voltage relative to ground.

[0055] In some embodiments, the control unit may be configured to operate the stimulator to generate a positive voltage pulse following one or more negative voltage pulses.

[0056] In some embodiments, the control unit may be configured to operate the stimulating device to generate a first stimulating signal having a frequency of 0.5 to 3 Hz, where the effector tissue is myocardial tissue.

[0057] In some embodiments, the control unit may be configured to operate the stimulator to generate a first stimulus signal having a frequency of 1 to 10 Hz, where the effector tissue is skeletal muscle tissue.

[0058] In some embodiments, the control unit may be configured to operate the stimulation device to generate a first stimulation signal having a frequency of 0.1 to 100 Hz, where the effector tissue is smooth muscle tissue.

[0059] In some embodiments, at least one of the first stimulus signal and the second stimulus signal may be an electrical signal or a vibration signal.

[0060] In some embodiments, the control unit may be configured to operate the stimulator to alternately apply a first stimulus signal and a second stimulus signal to the effector tissue.

[0061] In some embodiments, the system may further include a sensor device configured to generate a sensor signal indicating an effector response in the effector tissue, and a control unit may be configured to receive the sensor signal and control the operation of the stimulator based at least in part on the sensor signal.

[0062] In some embodiments, the sensor device may include sensor electrodes configured to measure electrical activity in effector tissue.

[0063] In some embodiments, the sensor device may include a sensor electrode configured to measure a change in electrical impedance in an effector tissue.

[0064] In some embodiments, the sensor device may include an electromyography sensor electrode configured to measure electrical activity in effector tissue and an electrical impedance sensor electrode configured to measure changes in electrical impedance in effector tissue.

[0065] In some embodiments, the sensor electrode may be configured to be placed in the effector tissue. The sensor may further include a reference electrode and may be configured to generate a sensor signal based on the electrical interaction between the sensor electrode and the reference electrode.

[0066] In some embodiments, the reference electrode may be formed by the housing of a stimulator or sensor device.

[0067] In some embodiments, the sensor device may be configured to measure the mechanical movement of the effector tissue.

[0068] In some embodiments, the sensor device may include a strain gauge configured to measure contraction or relaxation of effector tissue.

[0069] In some embodiments, the control unit may be configured to determine a response scale based on a sensor signal, the response scale representing the effector response.

[0070] In some embodiments, the control unit may be configured to compare a response scale with a predetermined reference scale and control the stimulator as follows: in response to the response scale being less than the reference scale, the intensity of a first stimulator signal is increased to stimulate the activity of the effector tissue; and in response to the response scale being greater than the reference scale, the intensity of a second stimulator signal is increased to suppress the activity of the effector tissue. The predetermined reference measurement may be based on a previous measurement of the effector response in the patient or a previous measurement of the effector response in another patient.

[0071] In some embodiments, the control unit may be configured to monitor the response scale of the effector response over time and to control the stimulator based on the rate of change of the effector response over time.

[0072] In some embodiments, the control unit may be configured to determine the calibration parameters of the stimulator based on a response scale.

[0073] In some embodiments, the stimulator may include a first electrode arrangement configured to deliver a first stimulus signal and a second electrode arrangement configured to deliver a second stimulus signal. The first electrode arrangement may include a first stimulating electrode and a second stimulating electrode, which are arranged at intervals along nerves supplying effector tissue.

[0074] In some embodiments, the stimulator may be configured to generate a first stimulation signal such that a first stimulation electrode functions as the cathode and a second stimulation electrode functions as the anode.

[0075] In some embodiments, the system may further include a cuff that is at least partially positioned around the nerve and configured to hold the first electrode arrangement in place relative to the nerve.

[0076] In some embodiments, the second electrode arrangement may include a third electrode and a fourth electrode, which are configured to be spaced apart along the nerve.

[0077] In some embodiments, the stimulator may be configured to generate a second stimulation signal such that a third electrode functions as the cathode and a fourth electrode functions as the anode.

[0078] In some embodiments, the system may further include a cuff that is at least partially positioned around the nerve and configured to hold the second electrode arrangement in place relative to the nerve.

[0079] In some embodiments, the system may further include an inhibitory electrode arrangement configured to apply an inhibitory signal that is bound to a nerve and inhibits action potentials that propagate within the nerve toward the central nervous system.

[0080] In some embodiments, the control unit may be configured to adjust the inhibitory signal to suppress the action potential induced in response to a stimulating device that applies a first stimulus signal.

[0081] In some embodiments, the stimulator may be configured to be coupled to a nerve at a position between the effector tissue and the inhibitory electrode placement so as to induce an action potential that travels through the nerve toward the effector tissue.

[0082] In some embodiments, the control unit may be configured to modulate the suppression of action potentials to suppress undesirable responses in the patient's nervous system, which are generated in response to the stimulator applying a first stimulus signal.

[0083] In some embodiments, the control unit may be configured to drive the stimulator and the inhibitory electrode arrangement so that each of the stimulator and the inhibitory electrode arrangement operates sequentially with a delay in the inhibitory signal that is timed to substantially match the conduction velocity of the first stimulator signal.

[0084] In some embodiments, the control unit may be configured to drive the stimulator and inhibitory electrode arrangement to apply the first stimulating signal and the inhibitory signal substantially simultaneously.

[0085] In some embodiments, the control unit may be configured to drive the stimulator and the suppression electrode arrangement such that the first stimulation signal and the suppression signal are both time-varying signals, the first stimulation signal is a low-frequency signal, and the suppression signal is a high-frequency signal. The amplitude of the first stimulation signal may vary in frequency in the range of 0.1 to 100 Hz, and the amplitude of the suppression signal may vary in frequency in the range of 1 to 10 kHz.

[0086] According to one embodiment, a system is provided for influencing a patient's effector response. The system comprises a stimulator including first and second electrode arrangements, each configured to be coupled to at least one of the patient's effector tissue and a nerve supplying the effector tissue; and a control unit configured to drive the stimulator to apply a stimulating signal via the first electrode arrangement to induce an effector response in the effector tissue, and an inhibitory signal via the second electrode arrangement to suppress action potentials propagating intraneuronally toward the central nervous system (CNS). The control unit is configured to adjust the inhibitory signal to suppress action potentials induced in response to the stimulator applying the stimulating signal.

[0087] In some embodiments, the first electrode arrangement may be configured to be coupled to a nerve at a position between the effector tissue and the second electrode, in order to induce an action potential that travels through the nerve toward the effector tissue.

[0088] In some embodiments, the control unit may be configured to modulate the suppression of action potentials to suppress undesirable responses in the patient's nervous system, which are generated in response to a first electrode to which a stimulating signal is applied.

[0089] In some embodiments, the control unit may be configured to drive the stimulator so that each of the first and second electrode arrangements is activated sequentially, with a delay in the inhibitory signal timed to substantially match the conduction velocity of the stimulation signal.

[0090] In some embodiments, the control unit may be configured to drive the stimulator to apply a stimulating signal and an inhibiting signal substantially simultaneously.

[0091] In some embodiments, the control unit may be configured to drive the stimulator such that the stimulation signal and the suppression signal are both time-varying signals, the stimulation signal is a low-frequency signal, and the suppression signal is a high-frequency signal. The amplitude of the stimulation signal may vary in the frequency range of 0.1 to 100 Hz, and the amplitude of the suppression signal may vary in the frequency range of 1 to 10 kHz.

[0092] In some embodiments, the first and second electrode arrangements may be configured to be spaced apart along the nerve.

[0093] In some embodiments, the first electrode arrangement may include a first stimulating electrode and a second stimulating electrode configured to apply a stimulating signal to effector tissue or nerve.

[0094] In some embodiments, the first and second stimulating electrodes may be configured to be spaced apart along the nerve.

[0095] In some embodiments, the stimulator may be configured to generate a stimulation signal such that a first stimulation electrode functions as a cathode and a second stimulation electrode functions as an anode.

[0096] In some embodiments, the system may further include a cuff that is at least partially positioned around the nerve and configured to hold the first electrode arrangement in place relative to the nerve.

[0097] In some embodiments, the second electrode arrangement may include a first inhibitory electrode and a second inhibitory electrode configured to apply an inhibitory signal to a nerve.

[0098] In some embodiments, the first and second inhibitory electrodes may be configured to be spaced apart along the nerve.

[0099] In some embodiments, the second electrode arrangement may further include a third suppression electrode configured to be spaced apart from the second suppression electrode, such that the second suppression electrode is positioned between the first and third suppression electrodes.

[0100] In some embodiments, the stimulator may be configured to generate an inhibitory signal such that the second inhibitory electrode functions as the cathode and the first and third inhibitory electrodes function as the anodes.

[0101] In some embodiments, the system may further include a cuff that is at least partially positioned around the nerve and configured to hold the second electrode arrangement in place relative to the nerve.

[0102] In some embodiments, the system may further include a sensor device configured to generate a sensor signal indicating an effector response in the effector tissue. A control unit may further be configured to receive the sensor signal and control the operation of the stimulator based at least in part on the sensor signal.

[0103] In some embodiments, the sensor device may include sensor electrodes configured to measure electrical activity in effector tissue.

[0104] In some embodiments, the sensor device may include a sensor electrode configured to measure a change in electrical impedance in an effector tissue.

[0105] In some embodiments, the sensor device may include an electromyography sensor electrode configured to measure electrical activity in effector tissue and an electrical impedance sensor electrode configured to measure changes in electrical impedance in effector tissue.

[0106] In some embodiments, the sensor electrode may be configured to be placed in the effector tissue. The sensor may further include a reference electrode and may be configured to generate a sensor signal based on the electrical interaction between the sensor electrode and the reference electrode.

[0107] In some embodiments, the reference electrode may be formed by the housing of a stimulating device or a sensor device.

[0108] In some embodiments, the sensor device may be configured to measure the mechanical movement of the effector tissue. The sensor device may include strain gauges configured to measure the contraction or relaxation of the effector tissue.

[0109] In some embodiments, the control unit may be configured to determine a response scale based on a sensor signal, the response scale representing the effector response. The control unit may compare the response scale to a predetermined reference measurement and control the stimulator to increase the intensity of the stimulation signal to stimulate effector tissue activity in response to the response scale being less than or equal to the reference measurement, and to decrease the intensity of the stimulation signal to suppress effector tissue activity in response to the response scale exceeding the reference measurement. The predetermined reference measurement may be based on a previous measurement of the effector response in the patient or a previous measurement of the effector response in another patient.

[0110] In some embodiments, the control unit may be configured to monitor the response scale of the effector response over time and to control the stimulator based on the rate of change of the effector response over time.

[0111] In some embodiments, the control unit may be configured to determine the calibration parameters of the stimulator based on a response scale.

[0112] According to one embodiment, a system is provided for influencing a patient's effector response, comprising: a stimulator configured to deliver a stimulus signal directly or indirectly to at least one of the patient's effector tissue and the nerves innervating the effector tissue; a sensor device configured to generate a sensor signal indicating an effector response in the effector tissue; and a control unit. The control unit is configured to receive the sensor signal and to control the operation of the stimulator based at least partially on the sensor signal.

[0113] In some embodiments, the sensor device may include sensor electrodes configured to measure electrical activity in effector tissue in response to a stimulus signal.

[0114] In some embodiments, the sensor device may include a sensor electrode configured to measure a change in electrical impedance in effector tissue in response to a stimulus signal.

[0115] In some embodiments, the sensor device may include an electromyograph sensor configured to measure electrical activity in effector tissue and an electrical impedance sensor configured to measure changes in electrical impedance in effector tissue.

[0116] In some embodiments, the sensor electrode may be configured to be placed in the effector tissue. The sensor electrode may include a reference electrode, and the sensor device may be configured to generate a sensor signal based on the electrical interaction between the sensor electrode and the reference electrode. The reference electrode may be formed by the housing of the stimulator or the sensor device.

[0117] In some embodiments, the sensor device may be configured to measure the mechanical movement of effector tissue in response to a stimulus signal. The sensor device may include strain gauges configured to measure contraction or relaxation of effector tissue in response to a stimulus signal.

[0118] In some examples, the sensor device may be configured to measure the patient's heart rate, blood pressure, or respiratory rate.

[0119] In some embodiments, the control device may be configured to determine a response scale based on a sensor signal, the response scale representing the effector response.

[0120] In some embodiments, the control unit may be configured to compare a response scale with a predetermined reference scale and control the stimulator as follows: increasing the intensity of the stimulus signal in response to the response scale being less than the reference scale, and decreasing the intensity of the stimulus signal in response to the response scale being greater than the reference scale.

[0121] In some embodiments, the control unit may be configured to increase the intensity of the stimulus signal by increasing at least one of the frequency, current amplitude, and voltage amplitude of the stimulus signal, and to decrease the intensity of the stimulus signal by decreasing at least one of the frequency, current amplitude, and voltage amplitude of the stimulus signal. A predetermined reference measurement may be based on a previous measurement of the effector response in a patient or a previous measurement of the effector response in another patient.

[0122] In some embodiments, the control device may be configured to monitor the level of the effector response over time and to control the stimulator based on the rate of change of the effector response over time.

[0123] In some embodiments, the control unit may be configured to determine the calibration parameters of the stimulator based on the response scale.

[0124] In some embodiments, the control unit may be configured to control the operation of the stimulator to produce an effector response, which is at least one of a muscle response and a glandular response. The effector tissue may be smooth muscle tissue such as a portion of the patient's blood vessels, intestines, or urinary bladder.

[0125] In some embodiments, the control unit may be configured to control the operation of the stimulator such that the stimulation signal is a periodic signal comprising at least one of a variable frequency component, a variable duty cycle component, a variable amplitude component, and a variable pause component. The stimulation signal may be either a low-frequency signal with an amplitude varying in the range of 0.1 to 100 Hz or a high-frequency signal with an amplitude varying in the range of 1 to 10 kHz. The stimulation signal may consist of a series of pulses having a negative voltage relative to ground.

[0126] In some embodiments, the control unit may be configured to operate the stimulator to generate a positive voltage pulse following one or more negative voltage pulses.

[0127] The stimulus signal may be an electrical signal or a vibrational signal.

[0128] In some embodiments, the stimulator may include a first stimulator electrode and a second stimulator electrode, which are configured to be spaced apart along the nerve supplying the effector tissue. The stimulator may be configured to generate a stimulatory signal such that the first stimulator electrode functions as the cathode and the second stimulator electrode functions as the anode. The system may further include a cuff, which is at least partially positioned around the nerve and configured to hold the first and second stimulator electrodes in place relative to the nerve.

[0129] In some embodiments, the system may further include an inhibitory electrode arrangement configured to apply an inhibitory signal that is bound to a nerve and inhibits action potentials propagating within the nerve toward the central nervous system. A control unit may be configured to modulate the inhibitory signal to inhibit action potentials induced in response to a stimulating device that applies a stimulating signal. Furthermore, the stimulator may be configured to be bound to the nerve at a position between the effector tissue and the inhibitory electrode arrangement to induce action potentials propagating within the nerve toward the effector tissue.

[0130] In some embodiments, the control unit may be configured to modulate the suppression of action potentials to suppress undesirable responses in the patient's nervous system, which are generated in response to a stimulating device that applies a stimulating signal.

[0131] In some embodiments, the control unit may be configured to drive the stimulator and inhibitory electrode arrangement so that each of the stimulator and inhibitory electrode arrangement operates sequentially with a delay in the inhibitory signal that is timed to roughly match the conduction velocity of the stimulator signal in the nerve.

[0132] In some embodiments, the control unit may be configured to drive the stimulator and inhibitory electrode arrangement to apply the first stimulating signal and the inhibitory signal substantially simultaneously.

[0133] In some embodiments, the control unit may be configured to drive the stimulator and the suppression electrode arrangement such that the stimulator and suppression signals are time-varying signals, the stimulator is a low-frequency signal, and the suppression signal is a high-frequency signal. The amplitude of the stimulator changes at a frequency in the range of 0.1 to 100 Hz, and the amplitude of the suppression signal changes at a frequency in the range of 1 to 10 kHz.

[0134] According to one embodiment, a system for stimulating a patient's effector tissue is provided. This system includes a stimulator configured to deliver a stimulating signal to at least one of the patient's effector tissue and the nerves innervating the effector tissue; an energy source configured to energize the stimulator; a control unit operably connected to the stimulator and configured to control the operation of the stimulator so that the stimulating signal elicits at least one of an effector response and / or inhibition of an effector response in the effector tissue; and a leakage current of the system of 1 μA or less, for example, 0.1 μA or less. It will be understood that a capacitor may be implemented in any of the embodiments and systems described above.

[0135] In some embodiments, the capacitor may be configured to be connected in series with the patient's body and at least one of the stimulator, energy source, and control unit.

[0136] In some embodiments, the stimulator may include an electrode arrangement configured to be coupled to effector tissue or nerves. A capacitor may be configured to be connected in series with the patient's body and the electrode arrangement.

[0137] In some embodiments, the electrode arrangement may include a first stimulation electrode and a second stimulation electrode for applying a stimulation signal. The capacitor may be configured to be connected in series with the first stimulation electrode and the second stimulation electrode.

[0138] In some embodiments, the capacitor may be incorporated into a circuit for controlling the operation of the stimulator.

[0139] In some embodiments, the system may further include a capacitor and a printed circuit board (PCB) supporting at least one of a stimulator, an energy source, and a control unit. The PCB may be at least one of a multilayer PCB, a flexible PCB, and a stretchable PCB.

[0140] According to one embodiment, a system for stimulating a patient's effector tissue is provided. The system comprises a stimulator configured to deliver a stimulating signal to at least one of the patient's effector tissue and the nerves innervating the effector tissue; an energy source configured to energize the stimulator; a control unit operably connected to the stimulator and configured to control the operation of the stimulator so that the stimulating signal elicits at least one of an effector response and / or inhibition of an effector response in the effector tissue; and a printed circuit board (PCB) supporting at least one of the stimulator, the energy source, and the control unit. The PCB is at least one of a multilayer PCB, a flexible PCB, or a stretchable PCB. It will be understood that the PCB can be mounted in any of the embodiments and systems described above.

[0141] In some embodiments, the PCB may include a first multilayer portion and a second multilayer portion interconnected by expandable portions.

[0142] In some embodiments, the PCB may include a first multilayer portion and a second multilayer portion interconnected by flexible portions.

[0143] An implantable electrically charged medical device is provided, configured to be held in place by a patient's tissue portion, the medical device comprising: a first portion configured to be positioned on a first side of a tissue portion, the first portion having a first cross-sectional area in a first plane and a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage with a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third plane The first part comprises a connecting part having a third surface having a third cross-sectional area and configured to engage with a first tissue surface on a first side of the tissue part, the connecting part being configured to connect the first part to the second part, wherein the first, second, and third planes are parallel to each other, the third cross-sectional area is smaller than the second cross-sectional area, and the first part, the second part, and the connecting part are prevented from moving through a hole in the tissue part in a direction perpendicular to the first, second, and third planes, the first part being 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 part being configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level, the frequency level being 100 kHz.

[0144] In some embodiments, the first part is configured to transmit electromagnetic waves with frequencies below a certain frequency level to the second part.

[0145] In some embodiments, the first part is configured to transmit electromagnetic waves with frequencies exceeding a certain frequency level to an external device.

[0146] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0147] In some embodiments, electromagnetic waves constitute radio energy and / or wireless communication.

[0148] In some embodiments, the first part comprises a first radio energy receiver for receiving energy radio-transmitted by an external radio energy transmitter at a higher frequency level, and an internal radio energy transmitter configured to radio-transmit energy to a second part at a lower frequency level, the second part comprising a second radio energy receiver configured to receive energy radio-transmitted by the internal radio energy transmitter at a lower frequency level.

[0149] In some embodiments, the first part comprises a first control device including at least one processing unit.

[0150] In some embodiments, the second part comprises a second control device including at least one processing unit.

[0151] In some embodiments, the first control unit is connected to a first radio communication receiver in the first part for receiving radio communications from external devices above the frequency level, and the first control unit is connected to a first radio communication transmitter in the first part for transmitting radio communications to a second radio communication receiver in the second part below the frequency level.

[0152] In some embodiments, the second control device is connected to a second wireless communication receiver for receiving wireless communications from the first portion at a frequency level below the specified frequency.

[0153] In some embodiments, the first part comprises an outer casing made of a polymer material.

[0154] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the first part must pass through the casing.

[0155] In some embodiments, the second portion comprises an outer casing made of titanium.

[0156] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the second part must pass through the casing.

[0157] An implantable electrically charged medical device is provided, configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of a tissue portion, the first portion having a first cross-sectional area in a first plane and a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage with a second tissue surface on the second side of the tissue portion; and a set extending between the first and second sides of the tissue portion A connecting portion configured to be positioned through a hole in a woven portion, the connecting portion having a third surface having a third cross-sectional area in a third plane and configured to engage with a first tissue surface of a first side of a tissue portion, the connecting portion configured to connect the first portion to the second portion, the first plane, the second plane and the third plane being parallel to each other, the third cross-sectional area being smaller than the second cross-sectional area, the first portion, the second portion and the connecting portion being 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 being configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level of 100 kHz.

[0158] In some embodiments, the second part is configured to receive and / or transmit electromagnetic waves at frequencies below the frequency level.

[0159] In some embodiments, the first part is configured to transmit electromagnetic waves with frequencies below a certain frequency level to the second part.

[0160] In some embodiments, the first part is configured to transmit electromagnetic waves with frequencies below a certain frequency level to an external device.

[0161] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0162] In some embodiments, electromagnetic waves constitute radio energy and / or wireless communication.

[0163] In some embodiments, the first part comprises a first radio energy receiver for receiving energy radio-transmitted by an external radio energy transmitter below a frequency level, and an internal radio energy transmitter configured to radio-transmit energy to a second part below a frequency level, the second part comprising a second radio energy receiver configured to receive energy radio-transmitted by the internal radio energy transmitter below a frequency level.

[0164] In some embodiments, the first part comprises a first control device including at least one processing unit.

[0165] In some embodiments, the second part comprises a second control device including at least one processing unit.

[0166] In some embodiments, the first control unit is connected to a first wireless communication receiver of the first part for receiving wireless communication from external devices at or below a frequency level, and the first control unit is connected to a first wireless communication transmitter of the first part for transmitting wireless communication to a second wireless communication receiver of the second part at or below a frequency level.

[0167] In some embodiments, the second control device is connected to a second wireless communication receiver for receiving wireless communications from the first portion at a frequency level below the specified frequency.

[0168] In some embodiments, the first part comprises an outer casing made of a polymer material.

[0169] In some embodiments, the first part comprises an outer casing made of titanium.

[0170] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the first part must pass through the casing.

[0171] In some embodiments, the second portion comprises an outer casing made of titanium.

[0172] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the second part must pass through the casing.

[0173] An implantable electrically charged medical device is provided, configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of a tissue portion, the first portion having a first cross-sectional area in a first plane and a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage with a second tissue surface on the second side of the tissue portion; and a hole in the tissue portion extending between the first and second sides of the tissue portion. A connecting portion configured to be positioned such that the connecting portion has a third surface having a third cross-sectional area in a third plane and configured to engage with a first tissue surface on a first side of the tissue portion, wherein the connecting portion is configured to connect the first portion to the second portion, the first, second and third planes being parallel to each other, the third cross-sectional area being smaller than the second cross-sectional area, and preventing the first portion, the second portion and the connecting portion from moving through the hole in the tissue portion in a direction perpendicular to the first, second and third planes, the first portion being made of a polymer material, and the second portion being a casing made of titanium, the casing forming a complete housing.

[0174] In some embodiments, the casing of the second portion forms a complete enclosure such that the entire outer surface of the second portion is covered by the casing when the second portion is connected to the connecting portion.

[0175] In some embodiments, the first part comprises a casing made of a polymer material.

[0176] In some embodiments, the casing of the first part forms a complete enclosure such that the entire outer surface of the first part is covered by the casing.

[0177] In some embodiments, the connection portion comprises a connection portion that connects to the first portion and the second portion, respectively, and is arranged to transmit electrical signals and / or energy.

[0178] In some embodiments, the connector is positioned within the core of the connector so as to be sealed by the outer material of the connector.

[0179] In some embodiments, the connecting portion is made of ceramic material.

[0180] In some embodiments, the connection is encapsulated within a ceramic material.

[0181] In some embodiments, the first part comprises a first connecting portion configured to connect to a connecting portion of the connecting part.

[0182] In some embodiments, the second portion comprises a second connector configured to connect to the connector of the connector.

[0183] In some embodiments, the casing of the second portion is hermetically sealed.

[0184] In some embodiments, the second connection is positioned such that the hermetically sealed portion of the second part is maintained.

[0185] In some embodiments, the first part of the casing is sealed.

[0186] An implantable electrically charged medical device is provided, configured to be held in place by a patient's tissue portion, the medical device comprising: a first portion configured to be positioned on a first side of a tissue portion, the first portion having a first cross-sectional area in a first plane and a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage with a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to engage with a first tissue surface on the first side of the tissue portion. The present invention comprises a connecting portion having a third surface, the connecting portion being configured to connect the first portion to the second portion, the first plane, the second plane, and the third plane being parallel to each other, the third cross-sectional area being smaller than the second cross-sectional area, preventing the first portion, the second portion, and the connecting portion from moving through the holes of the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane, the connecting portion being configured to extend between the first portion and the second portion along a central extension axis, the second portion being configured to extend in a longitudinal direction diverging from the central extension axis, the connecting portion having a substantially constant cross-sectional area along the central extension axis, or the connecting portion having a cross-sectional area that decreases in the direction from the first portion to the second portion along the central extension axis, and / or the second portion having a substantially constant cross-sectional area along the longitudinal direction, or the second portion having a cross-sectional area that decreases in the longitudinal direction.

[0187] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0188] In some embodiments, the connecting portion is tapered along the central extension axis from the first portion to the second portion.

[0189] In some embodiments, the connecting portion has a circular or elliptical cross-section along a central extension axis, with the diameter decreasing in the direction from the first portion to the second portion.

[0190] In some embodiments, the second portion is tapered in the longitudinal direction.

[0191] In some embodiments, the connecting portion has a circular or elliptical cross-section with a diameter that decreases in the longitudinal direction.

[0192] In some embodiments, the longitudinal direction extends from the interface between the connecting portion and the second portion toward the end of the second portion.

[0193] In some embodiments, the longitudinal direction extends substantially perpendicular to the central extension axis.

[0194] According to one embodiment, a method for implanting an electroconductive medical device is provided. The method includes positioning a second portion of an implantable electroconductive medical device between the peritoneum and the layer of muscular tissue of the abdominal wall. The method further includes positioning a first portion of the implantable electroconductive medical device between the patient's skin and the layer of muscular tissue of the abdominal wall. The first and second portions are configured to be connected by a connecting portion extending through at least one layer of muscular tissue of the abdominal wall. The method further includes positioning a body-engaging portion of the electroconductive medical device in connection with the patient's tissue or organ to be affected by the electroconductive medical device. The method further includes positioning at least partially a transmission member configured to transmit at least one of energy and force from the second portion to the body-engaging portion between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least one-third of the length of the transmission member is positioned outside the peritoneum.

[0195] According to one embodiment, an external device is provided which is configured to communicate with an implantable medical device when implanted in a patient. The external device comprises at least one first radio transceiver configured to communicate with the implantable medical device using a first network protocol to determine the distance between the external device and the implantable medical device, and at least one second radio transceiver configured to communicate with the implantable medical device using a second network protocol to transfer data between the external device and the implantable medical device.

[0196] According to one embodiment, an implantable medical device is provided which is configured to communicate with an external device. The implantable medical device comprises at least one first radio transceiver configured to communicate with the external device using a first network protocol to determine the distance between the external device and the implantable medical device, and at least one second radio transceiver configured to communicate with the external device using a second network protocol to transfer data between the external device and the implantable medical device.

[0197] According to one embodiment, an external patient device is provided which is configured to communicate with an implantable medical device when implanted in a patient. The external patient device comprises a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and to wirelessly communicate with a patient display device, and a computing unit configured to run control software for creating control commands for the operation of the implantable medical device. The computing unit is configured to transmit the control interface to a patient display device configured to display the control interface to a user, using the control interface as a remote display portal, to receive user input from the patient display device, and to convert the user input into control commands for wireless transmission to the implantable medical device.

[0198] According to one embodiment, a patient display device is provided for communicating with a patient remote external device for communicating with an implantable medical device. The patient display device comprises a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal from the patient remote external device and to wirelessly transmit implant control user inputs to the patient remote external device; a display for displaying the received implant control interface; and an input device for receiving implant control inputs from the user.

[0199] According to one embodiment, a communication system is provided that enables communication between a patient display device and an implantable medical device when implanted. The communication system comprises a patient display device, a server, and a patient remote external device. The patient display device comprises a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal provided by the patient remote external device. The wireless communication unit is further configured to wirelessly transmit implant control user inputs for the patient remote external device to the server. The system further comprises a display for displaying the received remote display portal and an input device for receiving implant control inputs from the user, the patient remote external device comprising a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and a computing unit. The computing unit is configured to run control software for creating control commands for the operation of the implantable medical device, transmit the control interface to the patient display device, receive implant control user inputs generated by the patient display device from the server, and convert the user inputs into control commands for wireless transmission to the implantable medical device.

[0200] According to one embodiment, a patient display device is provided for communicating with an external patient device when an implantable medical device is implanted. The patient display device comprises a wireless communication unit, a display, and an input device for receiving implant control inputs from a user. The patient display device is configured to run a first application for wireless communication with a server and / or DDI, and a second application for wireless communication with the external patient device for transmitting implant control inputs to a remote display portal of the external patient device for communication with the implantable medical device, the second application being configured to be accessed via the first application. The patient display device comprises a first login function and a second login function, the first login function allowing the user to access the first application, and a combination of the first and second login functions allowing the user to access the second application. The first login function may be configured to use at least one of a password, a PIN code, a fingerprint, voice, and facial recognition. The second login function within the first application is configured to authenticate a second hardware key of the external patient device for a defined period of time using a secret key from the user.

[0201] According to one embodiment, a communication system is provided that enables communication between a patient display device and an implantable medical device when implanted. The communication system comprises a patient display device, a server or DDI, and a patient remote external device. The patient display device comprises a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal from the patient remote external device, the wireless communication unit further comprises a display configured to wirelessly transmit implant control user inputs to the patient remote external device and to display the received implant control interface as a remote display portal, and an input device for receiving implant control inputs from a user. The patient display device is configured to run a first application for wireless communication with the server and a second application for wireless communication with the patient remote external device for transmitting implant control inputs to the remote display portal of the patient remote external device for communication with the implantable medical device. The patient remote external device comprises a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device based on implant control inputs and to wirelessly communicate with the patient display device.

[0202] According to one embodiment, a computer program product is provided which is configured to run on a patient display device comprising a wireless communication unit, a display for displaying a received implant control interface as a remote display portal, and an input device for receiving implant control input from a user. The computer program product comprises: a first application for communication with a server or DDI; and a second application for communication with a patient remote external device for transmitting implant control input via a remote display portal of the patient remote external device for communication with an implantable medical device, the second application comprising: a first application configured to be accessed via the first application; a first login function using at least one of a password, PIN code, fingerprint, or facial recognition; and a second login function within the first application using a secret key from the user to authenticate a second hardware key of the patient remote external device for a defined period of time. The first login function allows the user to access the first application, and a combination of the first and second login functions allows the user to access the second application.

[0203] According to one embodiment, a communication system is provided that enables communication between a patient display device, a patient external device, a server, and an implantable medical device. The communication system comprises a server, a patient display device, a patient external device, and an implantable medical device. The patient display device comprises a wireless communication unit for wirelessly communicating with at least one of the patient external device and the server, a display, and an input device for receiving input from a user. The patient external device comprises a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and to wirelessly communicate with at least one of the patient display device and the server. Furthermore, the server comprises a wireless communication unit configured to wirelessly communicate with at least one of the patient display device and the patient external device, and the implantable medical device comprises a wireless communication unit configured to wirelessly communicate with the patient external device. The implantable medical device further comprises an encryption unit configured to: encrypt data destined for the server, transmit the data to the server via the patient external device, and the patient external device acts as a router to transfer the data without complete decryption. In one embodiment, the implantable medical device is equipped with an encryption unit that encrypts data destined for the patient display device, transmits the data to the patient display device via an external patient device, and is configured to function as a router that transfers the data without full decryption. In one embodiment, the server is equipped with an encryption unit and is configured as follows: it encrypts data destined for the implantable medical device, transmits the data to the implantable medical device via an external patient device, and the external patient device functions as a router that transfers the data without full decryption; it encrypts data destined for the implantable medical device, transmits the data to the implantable medical device via the patient display device and the external patient device, and the patient display device and the external patient device function as a router that transfers the data without full decryption. In one embodiment, the patient display device is equipped with an encryption unit that encrypts data destined for the implantable medical device, transmits the data to the implantable medical device via an external patient device, and is configured to function as a router that transfers the data without full decryption.In one embodiment, the patient display device includes an encryption unit that encrypts data destined for an implantable medical device and transmits the data to the implantable medical device via a server and an external patient device, with the server and the external patient device acting as routers that transfer the data without full decryption.

[0204] According to one embodiment, a server is provided for use in a communication system according to the above embodiment or any one of the following embodiments.

[0205] According to one embodiment, a patient display device is provided for use in a communication system according to the above embodiment or any one of the following embodiments.

[0206] According to one embodiment, a patient external device is provided for use in a communication system according to the above embodiment or any one of the following embodiments.

[0207] According to one embodiment, an implantable medical device is provided for use in a communication system according to the above embodiment or any one of the following embodiments.

[0208] According to one embodiment, a system is provided configured to change the pre-programmed treatment settings of an implantable medical device implanted in a patient from a remote location relative to the patient. The system comprises at least one healthcare provider (HCP), an EID external device, and an HCP secret key device. The HCP EID external device is adapted to receive commands from the HCP to change the pre-programmed treatment settings of the implanted medical device, and is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing the HCP secret key device, the HCP secret key device being adapted to be provided to the HCP EID external device via a read slot or equivalent for the HCP secret key device and at least one of RFID communication or other short-range radio activation communication. The HCP EID external device comprises at least one of a read slot or equivalent for the HCP secret key device, RFID communication, and other short-range radio activation communication or electrical direct contact. The HCP EID external device further comprises at least one radio transceiver configured to communicate with a data infrastructure server DDI via a first network protocol.Furthermore, the system includes a data infrastructure server DDI adapted to receive commands from the HCP EID external device and relay the received commands to the patient EID external device without modifying them, the DDI comprising one radio transceiver configured to communicate with the patient external device and a patient EID external device adapted to receive commands relayed by the DDI, the implanted medical device further adapted to transmit commands to the implanted medical device, further adapted to receive commands from the HCP EID external device via the DDI to change the pre-programmed therapeutic settings of the implanted medical device, and further adapted to be activated, authenticated and authorized to execute the commands by the patient providing at least one patient secret key device adapted to be provided to the patient EID external device by the patient: a read slot or equivalent for the patient secret key device, RFID communication or other short-range radio activation communication or electrical direct contact. The patient EID external device comprises at least one of a read slot or equivalent for the HCP secret key device, RFID communication, other short-range radio activation communication or electrical direct contact. The patient EID external device further comprises at least one wireless transceiver configured to communicate with an implantable medical device via a second network protocol. Furthermore, the implanted medical device is configured to treat the patient or perform bodily functions.

[0209] According to one embodiment, a system is provided which, when implanted in a patient, is configured by a healthcare provider (HCP) to change a preprogrammed therapeutic setting of an implantable medical device in the physical presence of the patient. The system comprises at least one HCP EID external device adapted to receive commands from the HCP, directly or indirectly, to change the preprogrammed therapeutic setting in a step of the implantable medical device when the implantable medical device is implanted, the HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the command by an HCP providing an HCP secret key device containing an HCP secret key. The HCP secret key device comprises at least one of a smart card, a keychain device, a watch, a wristband or armband, a necklace, and a device of any shape. The HCP EID external device is adapted to be involved in at least one of receiving information from the implant, receiving information from a patient remote external device, activating the implanted medical device, changing a preprogrammed setting, and updating the software of the implanted medical device. The HCP EID external device is further adapted to also be activated, authenticated, and authorized to execute the command by the patient. The system further comprises a patient secret key device, which includes at least one of a smart card, a keychain device, a watch, an arm or wristband, a necklace, and a device of any shape. The HCP secret key and the patient secret key are necessary for the HCP EID external device to perform at least one of the following actions when the implantable medical device is implanted: receiving information from the implantable medical device, receiving information from the patient remote external device, activating the implantable medical device, changing pre-programmed settings, and updating the software of the implantable medical device.

[0210] In one embodiment, a system is provided which, when implanted in a patient, is configured to modify pre-programmed and pre-selected therapeutic actions of an implantable medical device by command from the patient. The system comprises an implantable medical device, a patient remote external device, a wireless transceiver configured to communicate with the implantable medical device via a second network protocol when the medical device is implanted, and a remote display portal. The remote display portal is configured to receive content delivered from the patient remote external device and to expose buttons for the patient to express their intention to activate the functions of the implantable medical device through the patient remote external device, and is further configured to remotely present a display portal on the patient display device that enables the patient to activate the functions of the implantable medical device through a display portal of the patient remote external device visualized on the patient display device.

[0211] According to one embodiment, a system is provided configured to provide information from an implantable medical device implanted in a patient to the patient from a remote location. The system comprises at least one patient EID external device adapted to receive information from the implantation, to further transmit such information to a server or dedicated data infrastructure (DDI), and to be activated and authenticated by the implantable medical device by the patient providing a secret key, thereby permitting the reception of the information. Furthermore, the system comprises a patient secret key device containing a secret key adapted to be provided to the patient EID external device via at least one of a read slot or equivalent for the patient secret key device, RFID communication or other short-range radio activation communication, or direct electrical connection. The patient EID external device comprises at least one of a read slot or equivalent for the patient secret key device, RFID communication, other short-range radio activation communication, or direct electrical contact. Furthermore, the patient EID external device comprises at least one radio transceiver configured to communicate with the DDI via a first network protocol.

[0212] In one embodiment, a system is provided, comprising an implantable medical device adapted to communicate with an external device when implanted in a patient, the external device including at least one of a patient remote external device or a patient EID external device. The system further comprises a patient EID external device adapted to communicate with the implantable medical device when implanted, to send commands to the implantable medical device, and to change pre-programmed settings, and a patient secret key device including a patient secret key adapted to activate, authenticate, and execute the commands by the patient EID external device, the secret key being adapted to be provided to the external device via at least one of a read slot for the HCP secret key device or equivalent, RFID communication or other short-range radio activation communication, or direct electrical contact. The system further comprises a data infrastructure server (DDI) adapted to transmit commands to the patient EID external device for further transmission to the implantable medical device to invalidate the authorization and authentication functions of the patient secret key.

[0213] According to one embodiment, a system is provided which, when implanted in a patient, allows a healthcare provider (HCP) to change a pre-programmed therapeutic setting in a step of an implantable medical device, either in the patient's physical presence or remotely with the patient. The system comprises at least one HCP EID external device adapted to receive commands directly or indirectly from the HCP to change the pre-programmed therapeutic setting in a step of the implantable medical device when implanted. The HCP EID external device is further adapted to be activated and authenticated by an HCP providing an HCP secret key device containing an HCP secret key, and to be authorized to execute the command. The HCP secret key comprises at least one of a smart card, a keychain device, a watch, an arm or wristband, a necklace, and a device of any shape. The system further comprises a patient secret key device containing a patient secret key, which comprises at least one of a smart card, a keychain device, a watch, an arm or wristband, a necklace, and a device of any shape. Both the HCP private key and the patient private key are required by the HCP EID external device to perform actions such as modifying pre-programmed settings of the implantable medical device and updating the software of the implantable medical device when the implantable medical device is implanted. The patient private key is adapted to invoke, authenticate, and authorize the execution of the aforementioned commands provided by the HCP when the action is performed remotely via the HCP EID external device or through the patient EID external device.

[0214] In one embodiment, a system is provided which, when implanted in a patient, is configured by a healthcare provider (HCP) to change pre-programmed therapeutic settings in a step of the implantable medical device while the patient is in a remote location. The system comprises at least one HCP EID external device adapted to receive commands directly or indirectly from the HCP to change the pre-programmed therapeutic settings in a step of the implantable medical device when implanted, the HCP EID external device is further adapted to be activated and authenticated by the HCP and authorized to execute the commands. When the implantable medical device is implanted, the actions of the HCP EID external device to change the pre-programmed settings of the implantable medical device and update the software of the implantable medical device are adapted to be authenticated by an HCP private key device and a patient private key device.

[0215] In one embodiment, a system is provided configured to change the pre-programmed treatment settings of an implantable medical device implanted in a patient from a remote location away from the patient. The system comprises at least one healthcare provider (HCP) external device adapted to receive commands from the HCP to change the pre-programmed treatment settings of the implantable medical device. The HCP external device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP secret key device adapted to be provided to the HCP EID external device via at least one of the following: a read slot or equivalent for an HCP secret key device, RFID communication, other short-range radio activation communication, or direct electrical contact. The HCP EID external device further comprises at least one radio transceiver configured to communicate with a patient EID external device via a first network protocol. The system comprises a patient EID external device, the patient EID external device is adapted to receive commands from the HCP external device and relay the received commands to an implantable medical device without modifying them. The patient EID external device comprises a wireless transceiver configured to communicate with the patient external device, the patient EID is adapted to transmit commands to the implantable medical device, to receive commands from the HCP to change the pre-programmed treatment settings of the implantable medical device, and is further adapted to be activated and authenticated by the patient providing a patient secret key device containing the patient secret key, thereby authorizing the execution of the commands.

[0216] According to one embodiment, the control device is configured to control the first and second stricture devices such that the first stricture device closes a first portion of the bladder. The second stricture device also narrows a second portion of the bladder to expel urine when the first portion of the bladder is closed.

[0217] According to one embodiment, the control device is configured to receive a pressure signal from a pressure sensor configured to measure the pressure applied to at least one of the first and second constricting devices.

[0218] According to the embodiment, at least one of the first and second stenosis devices is a hydraulic stenosis device.

[0219] According to the embodiment, at least one of the first and second stricture devices is a stricture device configured to electrically stimulate and narrow at least one tissue wall of the bladder.

[0220] According to one embodiment, a second stenosis device is configured to constrict a second portion of the bladder using electrical stimulation. The implantable pump device further comprises a cancellation unit configured to be positioned downstream of the second portion. This cancellation unit is configured to cancel the electrical stimulation so that the urethral sphincter muscle is substantially unaffected by the electrical stimulation.

[0221] According to one embodiment, the first stricture device is configured to narrow a first portion of the bladder that extends a first distance axially in the direction of urine flow. The second stricture device is configured to narrow a second portion of the bladder that extends a second distance axially in the direction of urine flow. The second distance is at least twice the length of the first distance.

[0222] According to the embodiment, at least one of the first and second stricture devices comprises at least one stricture element configured to contact a first portion of the bladder, and at least one abutment configured to contact a second portion of the bladder, for holding a force from at least one stricture element such that the bladder is narrowed between the at least one stricture element and the abutment.

[0223] According to the embodiment, at least one of the first and second stricture devices comprises at least first and second stricture elements. The first stricture element is configured to contact a first portion of the bladder, and the second stricture element is configured to contact a second portion of the bladder. As a result, the bladder is narrowed between the first and second stricture elements.

[0224] According to one embodiment, the implantable pump device further comprises a support element, and at least one of at least one constricting element and at least one abutment is connected to the support element.

[0225] According to one embodiment, the support element is configured to form at least a portion of a surrounding structure that is configured to surround the bladder.

[0226] According to one embodiment, the support element comprises at least one fluid conduit at least partially integrated with the support element.

[0227] According to one embodiment, the support element includes a connecting portion for connecting the support element to another support element in order to form at least partially a surrounding structure.

[0228] According to one embodiment, the support element constitutes part of a hinge for hinge-like connection of the support element to other support elements in order to at least partially form a surrounding structure.

[0229] According to the embodiment, at least one of the support element, at least one abutment, and at least one stenosis element has at least one curvature that conforms to the curvature of the bladder.

[0230] According to one embodiment, the implantable pump device further comprises an electrode arrangement configured to engage with and electrically stimulate the muscular tissue of the bladder to exercise the muscle tissue in order to improve the conditions for long-term implantation of the implantable pump device.

[0231] According to one embodiment, the abutment comprises at least one cushioning element configured to contact the bladder, the cushioning element being more elastic than the support element.

[0232] According to the embodiment, the first stricture device includes a first curved portion having a first radius that conforms to the curvature of the bladder. The second stricture device includes a second curved portion having a second radius that conforms to the curvature of the bladder. The first radius may be smaller than the second radius.

[0233] According to the embodiment, the first stenosis device may have an opening larger in its non-contracted state than the opening of the second stenosis device in its non-contracted state, so that the first stenosis device can first surround a portion of the bladder having a larger cross-section than the second portion that the second stenosis device can surround.

[0234] In one embodiment, the opening of the first stenosis device has an inner diameter of about 5–12 cm, preferably about 8–11 cm, in its uncontracted state, to accommodate a bladder of a corresponding size. In this context, diameter refers to the cross-sectional opening and does not need to be a perfectly circular opening, but rather an opening that fits the bladder.

[0235] In one embodiment, the opening of the second stenosis device has an inner diameter of about 1 to 8 cm, preferably about 2 to 5 cm, in the non-contracted state, and is capable of accommodating a bladder of the corresponding size.

[0236] According to one embodiment, the second stricture device comprises a plurality of stricture elements configured to sequentially narrow the bladder in order to drain urine from the bladder.

[0237] According to one embodiment, the mechanical structure device comprises at least one mechanical stenosis element comprising an electric motor, a screw, and a plate. The electric motor is configured to rotate the screw so as to push the plate toward the bladder in order to stenose the bladder.

[0238] According to one embodiment, the implantable pump device further comprises an electrical stimulator including electrodes provided on a constriction element and configured to electrically stimulate the constricted portion with electrical pulses.

[0239] According to one embodiment, the electrodes are configured to stimulate bladder tissue in order to avoid tissue damage due to pressure from the narrowing element.

[0240] According to one embodiment, the electrodes are configured to stimulate the bladder tissue in order to thicken the tissue in the narrowed area in order to close the passage of the bladder.

[0241] According to one embodiment, the implantable pump device further comprises a cancellation unit configured to be positioned downstream of the rotor and the stenosis element, the cancellation unit being configured to cancel electrical stimulation so that the urethral sphincter is substantially unaffected by the electrical stimulation.

[0242] According to one embodiment, the lumen of the first operable hydraulic stenosis element has a larger volume than the lumen of the second operable hydraulic stenosis element.

[0243] According to one embodiment, the lumen of the first operable hydraulic constriction element has a volume at least 1.5 times larger than the volume of the lumen of the second operable hydraulic constriction element.

[0244] According to one embodiment, the first interconnecting fluid conduit includes a first electrically operable valve that can control the fluid flow between a first operable hydraulic constriction element and a second operable hydraulic constriction element.

[0245] According to one embodiment, the electrically operable valve is a solenoid valve.

[0246] According to one embodiment, the first interconnecting fluid pipeline includes a check valve such that the fluid can flow from the first operable hydraulic constriction element to the second operable hydraulic constriction element, but cannot flow from the second operable hydraulic constriction element to the first operable hydraulic constriction element.

[0247] According to one embodiment, the implantable pump device further comprises a second interconnecting fluid conduit that fluidly connects a first operable hydraulic constriction element and a second operable hydraulic constriction element, wherein the cross-sectional area of ​​the lumen of the second interconnecting fluid conduit is less than 0.5 times the cross-sectional area of ​​the lumen of the first interconnecting fluid conduit.

[0248] According to one embodiment, an implantable pumping device further comprises a hydraulic pump, a reservoir for holding a hydraulic fluid, and a first reservoir conduit for fluidly connecting the reservoir to a first operable hydraulic constriction element. The hydraulic pump is configured to pump fluid from the reservoir through the first reservoir conduit to the first operable hydraulic constriction element in order to constrict a first portion of the bladder in order to restrict the flow of fluid through therein.

[0249] According to one embodiment, the first reservoir conduit includes a second electrically operable valve to control the fluid flow between the reservoir and a first operable hydraulic constriction element.

[0250] According to one embodiment, the plantable pump device further comprises a second reservoir conduit that fluidly connects the reservoir to a second operable hydraulic constriction element.

[0251] According to one embodiment, the second reservoir conduit includes a check valve such that fluid flows from the reservoir to the second operable hydraulic constriction element, but not from the second operable hydraulic constriction element to the reservoir.

[0252] According to one embodiment, the plantable pump device further comprises an injection port in fluid communication with the reservoir for injecting fluid into the reservoir when the reservoir is transplanted.

[0253] According to one embodiment, the injection port is configured to be located subcutaneously, and the implantable pump device further comprises an injection port conduit that fluidly connects the injection port to a reservoir.

[0254] According to one embodiment, the implantable pump device further comprises at least one of a first pressure sensor configured to sense pressure in a first operable hydraulic constriction element and a second pressure sensor configured to sense pressure in a second operable hydraulic constriction element.

[0255] According to one embodiment, the implantable pump device further comprises a control device configured to receive pressure sensor signals from at least one of a first and a second pressure sensor, and to control at least one of a first electrically operable valve, a second operable valve, and a hydraulic pump based on the received pressure sensor signals.

[0256] According to one embodiment, the control device includes a pressure threshold, and the control device is configured to open a first electrically operable valve when the pressure sensor signal received from a second pressure sensor exceeds the pressure threshold.

[0257] According to one embodiment, the implantable pump device further comprises a supportable and operable hydraulic stricture element. The supportable and operable hydraulic stricture element is configured to be positioned along at least a portion of a first portion of the urogenital tract and along at least a portion of a second portion of the urogenital tract. The supportable and operable hydraulic stricture element is configured to assist in the stricture of the first and second portions of the bladder.

[0258] According to one embodiment, a supportable and operable hydraulic constriction element is connected to first and second operable hydraulic constriction elements.

[0259] According to one embodiment, the supportable hydraulic constriction element is less elastic than at least one of the first and second operable hydraulic constriction elements.

[0260] According to one embodiment, each of the first, second, and supportable hydraulic constriction elements has a lumen surrounded by an elastic wall. The elastic wall of the supportable hydraulic constriction element is thicker than the wall of at least one of the first and second operable hydraulic constriction elements.

[0261] According to one embodiment, the implantable pump device further comprises a second hydraulic pump, a second reservoir for holding a hydraulic fluid, and a support reservoir conduit for fluid connection of the second reservoir to a supportable hydraulic constriction element. The second hydraulic pump is configured to pump fluid from the second reservoir through the support reservoir conduit to the supportable hydraulic constriction element to assist in the constriction of a lumen organ.

[0262] According to one embodiment, the implantable pump device further comprises a third pressure sensor configured to sense the pressure within a supportable, operable hydraulic constriction element.

[0263] According to one embodiment, the plantable pump device further comprises a second injection port in fluid communication with the second reservoir in order to inject fluid into the second reservoir when the second reservoir is transplanted.

[0264] According to one embodiment, the second injection port is configured to be located subcutaneously. The implantable pump device further comprises a second injection port conduit that fluidly connects the second injection port to a second reservoir.

[0265] According to one embodiment, the supportable hydraulic stricture element has an axial length of the bladder when implanted. The first and second operable hydraulic stricture elements have a combined length in the axial direction AD of the bladder, and the combined length is longer than the length of the supportable hydraulic stricture element.

[0266] According to one embodiment, the implantable pump device further comprises a peripheral structure having a peripheral portion that surrounds the bladder when implanted.

[0267] According to one embodiment, the surrounding structure is substantially rigid.

[0268] According to one embodiment, the main part of the surrounding structure is made of a material having an elastic modulus in the range of 0.2 GPa to 1000 GPa, or in the range of 1 GPa to 400 GPa.

[0269] According to one embodiment, the surrounding structure has an elastic modulus in the radial direction in the range of 0.2 GPa to 1000 GPa, or in the range of 1 GPa to 400 GPa.

[0270] According to one embodiment, the surrounding structure has an inner surface configured to face the bladder when implanted, and a supportable hydraulic stricture device is fixed to the inner surface of the surrounding structure, so that the supportable hydraulic stricture device can be used as a support for narrowing the bladder.

[0271] According to one embodiment, the implantable pump device further comprises at least one cushioning element configured to contact the bladder, the cushioning element being fixed to the inner surface of the surrounding structure and being more elastic than the surrounding structure.

[0272] According to one embodiment, the periphery structure is comprised of at least first and second support elements configured to be connected to one another in order to form at least a portion of the periphery of the periphery structure.

[0273] According to one embodiment, a supportable hydraulic stenosis device is fixed to a first support element, and at least one cushioning element is fixed to a second support element.

[0274] According to the embodiment, at least one of the first and second support elements has a curvature that matches the curvature of the bladder.

[0275] According to one embodiment, the curvature has a radius in the range of 15 mm to 60 mm.

[0276] According to one embodiment, the curvature has a radius in the range of 20 mm to 50 mm.

[0277] According to one embodiment, a supportable and operable hydraulic constriction element is connected to a first operable hydraulic constriction element.

[0278] According to one embodiment, the supportable hydraulic constriction element has lower elasticity than the first operable hydraulic constriction element.

[0279] According to one embodiment, the first operable hydraulic constriction element has a lumen surrounded by an elastic wall, and the supported operable hydraulic constriction element has a lumen surrounded by an elastic wall, and a portion of the elastic wall of the supported operable hydraulic constriction element is thicker than a portion of the elastic wall of the first operable hydraulic constriction element.

[0280] According to one embodiment, a portion of the elastic wall of a supportable hydraulic constriction element is 1.5 times or more thicker than a portion of the elastic wall of a first operable hydraulic constriction element.

[0281] According to one embodiment, a portion of the elastic wall of a supportable hydraulic constriction element is more than twice as thick as a portion of the elastic wall of a first operable hydraulic constriction element.

[0282] According to one embodiment, a first operable hydraulic constriction element has a lumen surrounded by an elastic wall. A supported hydraulic constriction element has a lumen surrounded by an elastic wall. A portion of the elastic wall of the first operable hydraulic constriction element is made of a first material. A portion of the elastic wall of the supported hydraulic constriction element is made of a second material. The second material has a higher elastic modulus than the first material.

[0283] According to one embodiment, the elastic modulus of the second material is 1.5 times or more that of the first material.

[0284] According to one embodiment, the elastic modulus of the second material is at least twice that of the first material.

[0285] According to one embodiment, the implantable pumping device further comprises a first hydraulic pump. The implantable pumping device further comprises a second hydraulic pump. The implantable pumping device further comprises a first reservoir for holding a hydraulic fluid. The implantable pumping device further comprises a second reservoir for holding a hydraulic fluid. The implantable pumping device further comprises a first reservoir conduit for fluid connection of the first reservoir to a first operable hydraulic constriction element. The implantable pumping device further comprises a support reservoir conduit for fluid connection of the second reservoir to a supportable hydraulic constriction element. The first hydraulic pump is configured to pump fluid from the first reservoir through the first reservoir conduit to the first operable hydraulic constriction element in order to constrict the bladder. The second hydraulic pump is configured to pump fluid from the second reservoir through a support reservoir constriction channel to a supportable, operable hydraulic constriction element in order to assist in bladder stricture.

[0286] According to one embodiment, the implantable pump device further comprises a second pressure sensor configured to sense the pressure within a supportable, operable hydraulic constriction element.

[0287] According to one embodiment, the implantable pumping device further comprises an implantable control device. The implantable control device is configured to control at least one of the first hydraulic pumps based on input from a first pressure sensor and to control a second hydraulic pump based on input from a second pressure sensor.

[0288] According to one embodiment, at least one of the first reservoir conduits is equipped with an electrically operable valve, and the second reservoir conduit is equipped with an electrically operable valve. The control device is configured to control at least one of the electrically operable valves of the first reservoir conduit based on an input from a first pressure sensor, and to control the electrically operable valve of the second reservoir conduit based on an input from a second pressure sensor.

[0289] According to one embodiment, the first reservoir conduit includes a check valve, and the second reservoir conduit includes a check valve.

[0290] According to one embodiment, the plantable pump device further comprises a first injection port in fluid communication with the first reservoir for injecting fluid into the first reservoir when the first reservoir is transplanted.

[0291] According to one embodiment, the plantable pump device further comprises a second injection port in fluid communication with the second reservoir in order to inject fluid into the second reservoir when the second reservoir is transplanted.

[0292] According to one embodiment, the implantable stenosis device is configured such that a first injection port is located subcutaneously, and further comprises a first injection port conduit that fluidly connects the first injection port to a first reservoir, or the implantable stenosis device is configured such that a second injection port is located subcutaneously, and further comprises a second injection port conduit that fluidly connects the second injection port to a second reservoir.

[0293] According to one embodiment, the supportable hydraulic stricture element, when implanted, has an axial length of the bladder, and the first operable hydraulic stricture element has an axial length of the bladder, and the length of the first operable hydraulic stricture element is longer than the length of the supportable hydraulic stricture element.

[0294] According to one embodiment, the support-operable hydraulic stenosis device is fixed to the first support element, and at least one cushion element is fixed to the second support element.

[0295] According to an embodiment, at least one of the first and second support elements has a curvature adapted to the curvature of the bladder.

[0296] According to an embodiment, the second distance is substantially opposite to the first direction.

[0297] According to one embodiment, the first hydraulic system includes a first hydraulic pump. The second hydraulic system includes a second hydraulic pump. The third hydraulic system includes a third hydraulic pump. The fourth hydraulic system includes a fourth hydraulic pump.

[0298] According to an embodiment, in each of the above aspects, each of the first, second, third, and fourth hydraulic systems includes a reservoir for holding hydraulic fluid.

[0299] According to one embodiment, the first, second, third, and fourth hydraulic systems are connected to a reservoir for holding hydraulic fluid.

[0300] According to one embodiment, each of the first, second, third, and fourth hydraulic systems includes injection ports for injecting hydraulic fluid into the respective first and second hydraulic systems.

[0301] According to one embodiment, the injection port is configured to be disposed subcutaneously, and the implantable pump device further includes an injection port conduit that fluidly connects the injection port (108) to the first, second, third, and fourth hydraulic systems. <​​​​​​According to the embodiment, the implantable pump device comprises at least one of a first pressure sensor configured to sense pressure in a first operable hydraulic constriction element, a second pressure sensor configured to sense pressure in a second operable hydraulic constriction element, a third pressure sensor configured to sense pressure in a third operable hydraulic constriction element, and a fourth pressure sensor configured to sense pressure in a fourth operable hydraulic constriction element.

[0304] According to one embodiment, the plantable pumping device includes a control unit configured to receive pressure sensor signals from at least one of first, second, third, and fourth pressure sensors. The control unit is configured to control at least one of the first, second, third, and fourth hydraulic pumps based on the received pressure sensor signals.

[0305] According to one embodiment, the surrounding structure has an inner surface configured to face the bladder when implanted, and the first, second, third, and fourth operable hydraulic stricture elements are fixed to the inner surface of the surrounding structure.

[0306] According to one embodiment, the periphery structure is comprised of at least first and second support elements configured to be connected to one another in order to form at least a portion of the periphery of the periphery structure.

[0307] According to one embodiment, the first and third operable hydraulic constriction elements are fixed to the first support element. The second and fourth operable hydraulic constriction elements are fixed to the second support element.

[0308] According to one embodiment, the electrode arrangement is positioned on the outer surface of at least one of a first operable hydraulic constriction element and a second operable hydraulic constriction element.

[0309] According to one embodiment, the electrode arrangement comprises multiple electrode elements, each electrode element configured to engage with bladder tissue and provide electrical stimulation.

[0310] According to one embodiment, the electrode arrangement includes a coiled wire to increase the contact surface between the electrode arrangement and the bladder tissue, allowing the electrode arrangement to follow the narrowing and relaxation of the bladder tissue.

[0311] According to one embodiment, the electrode arrangement includes exposed electrode portions configured to form a metal-tissue interface with bladder tissue, thereby making Faradayian charge transfer dominant as the charge transfer mechanism at the interface.

[0312] According to one embodiment, the electrode arrangement includes an electrode portion at least partially covered by a dielectric material configured to form a dielectric-tissue interface with the bladder tissue, thereby reducing the Faraday portion of the charge transfer mechanism at the interface.

[0313] According to one embodiment, the electrode arrangement comprises at least two electrode elements configured to be positioned on opposite sides of the bladder.

[0314] According to one embodiment, the implantable pump device further comprises a stimulation control device configured to be operably connected to an electrode arrangement for controlling electrical stimulation of bladder tissue.

[0315] According to one embodiment, the stimulation control device is configured to control electrical stimulation so that the bladder tissue is stimulated by a series of electrical pulses.

[0316] According to one embodiment, the stimulation control device is configured to control electrical stimulation such that a pulse of a first polarity is followed by a pulse of the second opposite polarity.

[0317] According to one embodiment, the stimulation control device is configured to generate a pulsed electrical stimulation signal having a pulse frequency of 0.01 to 150 Hz.

[0318] According to one embodiment, the electrical stimulation signal has a pulse duration of 0.01 to 100 ms.

[0319] According to one embodiment, the electrical stimulation signal has a pulse amplitude of 1 to 15 mA.

[0320] According to one embodiment, the electrical stimulation signal has a pulse frequency of 0.15 to 0.25 Hz, a pulse duration of 20 to 30 ms, and a pulse amplitude of 3 to 10 mA.

[0321] According to one embodiment, the electrical stimulation signal has a build-up period of 0.01 - 2 seconds with a gradually increasing amplitude, a stimulation period of 1 - 60 seconds, and a stimulation rest period of 0.01 - 60 seconds, and the electrical signal has a pulse frequency of 1 - 50 Hz and a pulse duration of 0.1 - 10 ms.

[0322] According to one embodiment, the stimulation control device is configured to receive an input from a wireless remote control device.

[0323] According to one embodiment, the implantable pump device further comprises an implantable sensor configured to sense the action potential generated by the pacemaker cells of the bladder tissue, and the stimulation control device is configured to control the electrical simulation at least partially based on the sensed action potential.

[0324] According to one embodiment, the stimulation control device is configured to generate an electrical pulse that amplifies the sensed action potential.

[0325] According to one embodiment, the surrounding structure comprises at least one cushion element. At least one electrode element of the electrode arrangement is disposed on the surface of the cushion element.

[0326] According to an embodiment, the motors of the first and / or second constriction devices are electric motors.

[0327] According to one embodiment, the motor is a brushless implantable DC motor.

[0328] According to one embodiment, the plantable pumping device further comprises a gear system positioned between a motor and first and second hydraulic pumps, the gear system configured to reduce the speed and increase the force of the motion generated by the motor in order to mechanically propel the first and second hydraulic pumps at a lower speed and with greater force.

[0329] According to one embodiment, the motor is configured to generate rotational force and propel the first and second hydraulic pumps with rotational mechanical force.

[0330] According to the embodiment, the rotational force output of the motor is connected to the force input of the gear system. The rotational force output of the gear system is then connected to the first and second hydraulic pumps.

[0331] According to one embodiment, at least one of the first and second hydraulic pumps of the first and / or second constricting device is equipped with a gear pump.

[0332] According to the embodiment, at least one of the first and second hydraulic pumps of the first and / or second constriction device is equipped with a peristaltic pump.

[0333] According to one embodiment, at least one of the first and second hydraulic pumps of the first and / or second constriction device comprises a pump including at least one compressible hydraulic reservoir.

[0334] According to the embodiment, at least one of the first and second hydraulic pumps of the first and / or second constriction device is equipped with a jettor pump.

[0335] According to one embodiment, a first hydraulic pump comprises a first jerro pump. A second hydraulic pump comprises a second jerro pump. The first and / or second constriction device further comprises a common rotating shaft mechanically connected to a motor. The inner rotor of the first jerro pump is mechanically connected to the common rotating shaft. The inner rotor of the second jerro pump is mechanically connected to the common rotating shaft, and the motor is configured to propel the first and second jerro pumps.

[0336] According to one embodiment, the implantable pump device further comprises an implantable reservoir. At least one of the first and second hydraulic pumps of the first and / or second constriction device is connected to the implantable reservoir.

[0337] According to the embodiment, the first constriction device and / or the second constriction device further comprises a first implantable reservoir (107) and a second implantable reservoir, wherein a first hydraulic pump is connected to the first implantable reservoir, and a second hydraulic pump is connected to the second implantable reservoir.

[0338] According to one embodiment, the first constriction device and / or the second constriction device further comprises an implantable reservoir. First and second hydraulic pumps are connected to the implantable reservoir to pump hydraulic fluid from the first reservoir to a first operable hydraulic constriction element and from the second reservoir to a second operable hydraulic constriction element.

[0339] According to one embodiment, a first operable hydraulic stenosis element of a first stenosis device is configured to be inflated and thereby expand in a first direction toward the bladder to stenose a first portion of a lumen organ to restrict the flow of fluid therethrough. A second operable hydraulic stenosis element of the first stenosis device is a supporting operable hydraulic stenosis element configured to support the first operable hydraulic stenosis element when it is inflated and thereby expand in a first direction toward the bladder to stenose a first portion of the bladder to restrict the flow of fluid therethrough.

[0340] According to one embodiment, the first operable hydraulic stenosis element of the second stenosis device is configured to be inflated and thereby expand in a first direction toward the bladder to restrict the flow of fluid through therein and to narrow a second portion of the tubular organ to drain urine from the bladder. The second operable hydraulic stenosis element of the second stenosis device is a supported operable hydraulic stenosis element configured to support the first operable hydraulic stenosis element when it is inflated and thereby expands in a first direction toward the bladder to restrict the flow of fluid through therein and to narrow a first portion of the bladder to drain urine from the bladder.

[0341] According to one embodiment, a supportable and operable hydraulic constriction element is connected to a first operable hydraulic constriction element.

[0342] According to one embodiment, the supportable hydraulic constriction element has lower elasticity than the first operable hydraulic constriction element.

[0343] According to one embodiment, the first operable hydraulic constriction element of the first throttling device and / or the second throttling device comprises a lumen surrounded by an elastic wall. The supported operable hydraulic constriction element comprises a lumen surrounded by an elastic wall. A portion of the elastic wall of the supported operable hydraulic constriction element is thicker than a portion of the elastic wall of the first operable hydraulic constriction element.

[0344] According to one embodiment, the first constriction device and / or the second constriction device further comprises a first pressure sensor configured to sense the pressure within a first operable hydraulic constriction element.

[0345] According to one embodiment, the first constriction device and / or the second constriction device further comprises a second pressure sensor configured to sense the pressure within a second operable hydraulic constriction element.

[0346] According to one embodiment, the implantable pump device further comprises an implantable control device. The implantable control device is configured to control at least one of a first hydraulic pump of a first constriction device and / or a second constriction device based on an input from a first pressure sensor, and a second hydraulic pump of the first constriction device and / or a second constriction device based on an input from a second pressure sensor.

[0347] According to one embodiment, the first constriction device and / or the second constriction device further comprises a first implantable injection port that is in fluid communication with a first operable hydraulic constriction element.

[0348] According to one embodiment, the first and / or second constriction device further comprises a second implantable injection port that is in fluid communication with a second operable hydraulic constriction element.

[0349] According to one embodiment, the plantable energy storage device is a rechargeable battery.

[0350] According to one embodiment, the plantable energy storage device is a solid-state battery.

[0351] According to one embodiment, the battery is a thionyl chloride battery.

[0352] According to one embodiment, an implantable energy storage unit is connected to at least one of a first and a second hydraulic pump and is configured to power the first and / or second hydraulic pump after being started using a capacitor.

[0353] According to one embodiment, the capacitor is configured to store energy for supplying a burst of energy to at least one of the first and second hydraulic pumps.

[0354] In one embodiment, the capacitor is a start capacitor.

[0355] According to one embodiment, the capacitor is a ran-through capacitor.

[0356] According to one embodiment, the capacitor is a dual-run capacitor.

[0357] According to one embodiment, the implantable pumping device further comprises a second capacitor, which is charged by an implantable energy storage unit and configured to supply power to at least one of the first and second hydraulic pumps.

[0358] According to one embodiment, the capacitor is a supercapacitor.

[0359] According to one embodiment, at least one of the first and second hydraulic pumps is equipped with an electric motor (M) for operating the hydraulic pump.

[0360] According to one embodiment, the capacitor is further configured to supply power to at least one of the following: a device for applying electrical stimulation to a tissue portion of the patient's body; a CPU for encrypting information; a transceiver unit for communicating with an external device; a measuring unit or sensor; a data acquisition unit; a solenoid; a piezoelectric element; and a memory metal unit.

[0361] According to one embodiment, the capacitor is further configured to supply power to the valve.

[0362] According to one embodiment, the capacitor is further configured to supply power to a control device for controlling at least a portion of the plantable pump device.

[0363] According to one embodiment, the implantable pump device further comprises an external energy storage unit located outside the patient's body and configured to supply energy to an implantable energy storage unit. The implantable pump device further comprises an implantable energy receiver electrically connected to the implantable energy storage unit and configured to enable the external energy storage unit to charge the implantable energy storage unit.

[0364] According to one embodiment, the plantable pump device further comprises a temperature sensor for sensing the temperature of a plantable energy storage unit.

[0365] According to one embodiment, the plantable pump device further comprises a temperature sensor for sensing the temperature of the capacitor.

[0366] According to one embodiment, the sensor is at least one of a Hall effect sensor, a fluxgate sensor, an ultra-high sensitivity magnetic field sensor, and a magnetoresistive sensor.

[0367] According to one embodiment, the frequency of the magnetic field generated by the coil is 9 to 315 kHz.

[0368] According to one embodiment, the frequency of the magnetic field generated by the coil is 125 kHz or less, preferably 58 kHz or less.

[0369] According to one embodiment, the control device includes a receiving unit. The control device and the external control unit are configured to transmit and / or receive data via magnetic induction through the receiving unit and the first coil.

[0370] According to one embodiment, the receiving unit is equipped with a high-sensitivity magnetic field detector.

[0371] According to one embodiment, the receiving unit is composed of a second coil.

[0372] According to one embodiment, the implantable pump device further comprises an implantable energy storage unit electrically connected to a receiving unit, the implantable energy storage unit being adapted to be charged by an external control unit via the receiving unit.

[0373] According to one embodiment, an implantable energy storage unit is configured to be charged via magnetic induction between a first coil and a second coil.

[0374] According to one embodiment, the receiving unit is configured to control the charging of the plantable energy storage unit by controlling the reception of power from the external control unit.

[0375] According to one embodiment, the internal receiving unit is configured to control the charging of the plantable energy storage unit by controlling the power transmission from the external control unit to the receiving unit.

[0376] According to one embodiment, the implantable pump device further comprises a sensory generator adapted to produce a sensation detectable by the patient's senses, the sensory generator being connected to a control device or external control unit and configured to produce a sensation when implanted in the patient, as needed.

[0377] According to one embodiment, the sensory generator is configured to receive requests from a control device or an implantable pump device.

[0378] According to one embodiment, the sensory generator is configured to receive requests from an external device.

[0379] According to one embodiment, the sensory generator is configured to produce a sensation comprising multiple sensory components.

[0380] According to one embodiment, the sensory generator (381) is configured to produce sensation or sensory components by at least one of the following: vibration of the sensory generator, generation of sound, supply of light signals, supply of electrical signals, and supply of thermal signals.

[0381] According to one embodiment, the sensory generator is adapted to be implanted in a patient.

[0382] According to one embodiment, the sensory generator is configured to be attached in contact with the patient's skin.

[0383] According to one embodiment, the sensory generator is configured to generate sensations without physical contact with the patient.

[0384] According to one embodiment, the external control device is comprised of a wireless remote control.

[0385] According to one embodiment, the wireless remote control includes an external signal transmitter. An internal receiver is further configured to receive a signal transmitted by the external signal transmitter when the processing unit is in an active state, and to control the operation of the device based on the signal.

[0386] According to one embodiment, the signal is selected from the group comprising sound signals, ultrasonic signals, electromagnetic wave signals, infrared signals, visible light signals, ultraviolet signals, laser signals, microwave signals, radio wave signals, X-ray signals, and gamma-ray signals.

[0387] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device including first, second, and third urinary contact elements. The first urinary contact element comprises a first operable hydraulic stricture element configured to inflate to narrow the bladder in order to restrict the flow of fluid therethrough. The second urinary organ contact element comprises a second operable hydraulic stricture element configured to inflate to help release the bladder stricture in order to restore the flow of fluid therethrough. The third urinary contact element comprises at least one cushioning element configured to contact the bladder.

[0388] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device including a first operable hydraulic constriction element configured to inflate to restrict the flow of fluid through the bladder. The implantable pump device further comprises a second operable hydraulic constriction element configured to constrict the bladder to restrict the flow of fluid through the bladder and to inflate to drain urine from the bladder. The implantable pump device further comprises an interconnecting fluid conduit that fluidly connects the first operable hydraulic constriction element to the second operable hydraulic constriction element. The first operable hydraulic constriction element is configured to be positioned in a first portion of the bladder to constrict a first portion of the bladder to restrict the flow of fluid through it. The second operable hydraulic constriction element is configured to be positioned in a second portion of the urinary tract downstream of the first portion to constrict a second portion of the bladder to restrict the flow of fluid through it and to drain urine from the bladder. The connecting fluid conduit is configured such that when the pressure in the first operable hydraulic constriction element increases, fluid is conducted from the first operable hydraulic constriction element to the second operable hydraulic constriction element, causing the second operable hydraulic constriction element to further constrict the second portion of the bladder.

[0389] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device which includes a first operable hydraulic stenosis element configured to be inflated and thereby expand in a first direction toward the bladder to narrow a first portion of the bladder in order to restrict the flow of fluid through therein. The implantable pump device further comprises a support operable hydraulic stenosis element configured to support the first operable hydraulic stenosis element when it is inflated and thereby expand in a first direction toward the bladder to narrow a first portion of the bladder in order to restrict the flow of fluid through therein.

[0390] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device which includes at least two implantable stenosis devices, each including a first operable hydraulic stenosis element configured to expand to exert pressure on the bladder in a first direction to restrict the flow of fluid through it to a first portion of the bladder. The implantable stenosis device further includes a second operable hydraulic stenosis element configured to expand to exert pressure on the bladder in a second direction to restrict the flow of fluid through it to a first portion of the bladder. The implantable stenosis device further includes a first hydraulic system in fluid communication with the first operable hydraulic stenosis element and a second hydraulic system in fluid communication with the second operable hydraulic stenosis element. The first and second operable hydraulic stenosis elements are independently adjustable.

[0391] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device consisting of at least two implantable stenotic devices. Each implantable stenotic device comprises an operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a hydraulic reservoir for holding hydraulic fluid. Each implantable stenotic device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the operable hydraulic stenotic element. Each implantable stenotic device further comprises a first fluid conduit forming a fluid connection between the hydraulic reservoir and the hydraulic pump. Each implantable stenotic device further comprises a second fluid conduit forming a fluid connection between the hydraulic pump and the operable hydraulic stenotic element. Each implantable stenotic device further comprises an injection port for injecting and removing hydraulic fluid from the implantable stenotic device when implanted. Each implantable constriction device further comprises a third fluid conduit forming a fluid connection between an injection port and at least one of a second fluid conduit and an operable hydraulic constriction element, so that a hydraulic fluid can be removed from the operable hydraulic constriction element through the injection port.

[0392] According to one embodiment, the step of inserting an implantable pump device into a patient's body involves inserting an implantable pump device comprising at least two implantable stenotic devices. Each implantable stenotic device comprises an operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a hydraulic reservoir for holding hydraulic fluid. Each implantable stenotic device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the operable hydraulic stenotic element. Each implantable stenotic device further comprises a first fluid conduit forming a fluid connection between the hydraulic reservoir and the hydraulic pump. Each implantable stenotic device further comprises an electrode arrangement positioned between the implantable stenotic device and the bladder, configured to engage with the muscular tissue of the bladder to electrically stimulate and move the muscular tissue, thereby improving the long-term implantation conditions of the implantable stenotic device.

[0393] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device comprising at least two implantable stenotic devices. Each implantable stenotic device comprises a first operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a second operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a first hydraulic pump for pumping fluid to the operable hydraulic stenotic elements. Each implantable stenotic device further comprises a second hydraulic pump for pumping fluid to the operable hydraulic stenotic elements. Each implantable stenotic device further comprises a motor. The motor is mechanically connected to the first and second hydraulic pumps to propel the first and second hydraulic pumps.

[0394] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device comprising at least two implantable stenotic devices. Each implantable stenotic device comprises an operable hydraulic stenosis element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a pressure sensor configured to sense the pressure within the operable hydraulic stenosis element. Each implantable stenotic device further comprises a hydraulic pump for pumping hydraulic fluid into the operable hydraulic stenosis element. Each implantable stenotic device further comprises a control device configured to receive a pressure sensor input from the pressure sensor and to control the hydraulic pump based on the received pressure sensor input. The pressure sensor comprises a diaphragm, which is in fluid communication with the hydraulic fluid within the operable hydraulic stenosis element. The diaphragm is further connected to a pressure sensing element of the pressure sensor, which is separated from the hydraulic fluid within the operable hydraulic stenosis element by the diaphragm.

[0395] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device comprising at least two implantable stenotic devices. Each implantable stenotic device comprises an operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a hydraulic pump for pumping hydraulic fluid into the operable hydraulic stenotic element. The hydraulic pump comprises a compressible reservoir configured to hold the hydraulic fluid to be moved into the operable hydraulic stenotic element. Each implantable stenotic device further comprises a motor comprising a shaft. The motor is configured to generate a radial force by the rotation of the shaft. Each implantable stenotic device further comprises a gearbox configured to transmit the radial force to substantially an axial force on the shaft for compressing the compressible reservoir. Each implantable stenotic device further comprises at least one bearing for the shaft. The bearing is configured to hold at least half of the axial force to reduce the axial load on at least one of the motor and the gear system caused by the compression of the reservoir.

[0396] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device comprising at least two implantable stenotic devices. Each implantable stenotic device comprises at least one implantable operable hydraulic stenosis element. Each implantable operable hydraulic stenosis element includes a contact wall portion configured to engage with the bladder in order to exert force on the bladder. Each implantable operable hydraulic stenosis element further comprises a retaining wall portion configured to connect to a retaining structure for holding the force exerted on the bladder so that the bladder is stenotic. Each implantable operable hydraulic stenosis element further comprises a connecting wall portion connecting the contact wall portion to the retaining wall portion. A first portion of the connecting wall portion is connected to the contact wall portion. A second portion of the connecting wall portion is connected to the retaining wall portion. The first portion of the connecting wall portion is more elastic than the second portion of the connecting wall portion.

[0397] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device consisting of at least two implantable stenotic devices. Each implantable stenotic device comprises an operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device further comprises a hydraulic pump for pumping hydraulic fluid to the operable hydraulic stenotic element. Each implantable stenotic device comprises an implantable energy storage unit. Each implantable stenotic device comprises a capacitor connected to the implantable energy storage unit and connected to the hydraulic pump. The capacitor is charged by the implantable energy storage unit and configured to supply power to the hydraulic pump.

[0398] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable pump device consisting of at least two implantable stenotic devices. Each implantable stenotic device comprises an operable hydraulic stenotic element configured to inflate to apply pressure to the bladder. Each implantable stenotic device comprises a hydraulic pump for pumping hydraulic fluid into the operable hydraulic stenotic element. Each implantable stenotic device comprises a control unit configured to control the hydraulic pump. The control unit comprises a sensor adapted to detect a magnetic field and a processing unit having a sleep mode and an active mode. Each implantable stenotic device comprises an external control unit adapted to be located outside the patient's body, the external control unit comprising a first coil adapted to form a magnetic field detectable by the internal sensor. The control unit is further configured to set the processing unit to active mode in response to the detected magnetic field exceeding a predetermined value.

[0399] According to one embodiment, the step of positioning an implantable pump device in relation to the bladder comprises positioning the implantable pump device around the patient's bladder.

[0400] According to one embodiment, the step of connecting and positioning an implantable pump device to the bladder includes closing a locking or fixing device of the implantable pump device around the bladder to secure the implantable pump device to the patient's bladder.

[0401] According to one embodiment, the step of positioning an implantable pump device in relation to the bladder comprises securing the implantable pump device by at least one of sutures, staples, and tissue growth promoting structures.

[0402] According to one embodiment, the step of inserting an implantable pump device into a patient's body comprises inserting an implantable control device into the patient's body and fixing the implantable control device to the patient's tissue or bone.

[0403] According to one embodiment, the step of inserting an implantable pump device into a patient's body includes inserting an operating device which includes at least one of an implantable hydraulic pump and an implantable valve, and fixing the implantable operating device to the patient's tissue or bone.

[0404] According to one embodiment, the method further includes the step of implanting and fixing at least one injection port in fluid communication with an operating device.

[0405] According to one embodiment, the step of securing at least one injection port includes the step of securing the injection port subcutaneously.

[0406] According to one embodiment, the method further includes the step of calibrating the fluid level in an implantable pump device.

[0407] According to one embodiment, the method further includes calibrating at least one of the following: the pressure exerted by the implantable pump device on the bladder, the time the implantable pump device remains closed after activation, the rate at which the implantable pump device should narrow the bladder, the pressure exerted by the implantable pump device on the bladder relative to the patient's blood pressure, the pressure exerted by the implantable pump device on the bladder by the pressure-sensitive catheter, and the pressure exerted by the implantable pump device on the bladder relative to the patient's blood pressure.

[0408] According to one embodiment, the method further includes testing at least one of the following: a fully open catheter mode, a feedback function by providing sensory feedback to the patient, a postoperative mode to enable healing, a postoperative mode to enable the growth of fibrotic tissue, and electrical stimulation of bladder tissue.

[0409] According to one embodiment, the method further includes positioning a second portion of an implantable electroconductive medical device between the peritoneum and the layer of abdominal wall muscle tissue. The method further includes positioning a first portion of the implantable electroconductive medical device between the patient's skin and the layer of abdominal wall muscle tissue, wherein the first and second portions are connected by a connecting portion extending through at least one layer of abdominal wall muscle tissue. The method further includes positioning at least partially a transmission member configured to transmit at least one of energy and force from the second portion to an implantable pump device between the peritoneum and the layer of abdominal wall muscle tissue, wherein at least one-third of the length of the transmission member is positioned outside the peritoneum.

[0410] According to one embodiment, the step of measuring the pressure in a first and / or second implantable hydraulic stricture element when there is substantially no pressure on the bladder further includes comparing the measured pressure with atmospheric pressure.

[0411] According to one embodiment, the step of comparing the measured pressure with atmospheric pressure comprises measuring atmospheric pressure using a pressure sensor connected to a signal transmitter located outside the patient's body.

[0412] According to one embodiment, the step of raising the pressure of the first and second implantable hydraulic constriction elements to a specified level comprises inflating the first and / or second implantable hydraulic constriction elements to a specified cross-sectional distance.

[0413] According to one embodiment, the method further includes measuring the pressure in a first and / or second implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element increases.

[0414] According to one embodiment, the steps of measuring the pressure in a first and / or second implantable hydraulic stricture element when there is substantially no pressure on the bladder, and measuring the pressure in a first and / or second implantable hydraulic stricture element when the pressure in the implantable hydraulic stricture element increases, are performed using the same pressure sensor.

[0415] According to one embodiment, the method further comprises the step of creating an absolute pressure by subtracting the pressure in the first and / or second implantable hydraulic stricture element when there is substantially no pressure acting on the bladder from the pressure in the hydraulic stricture element when the pressure in the implantable hydraulic stricture element increases, in the control device. The step of controlling the operating device comprises controlling the operating device based on the absolute pressure.

[0416] According to one embodiment, the calculation unit is further configured to compare the measured pressure with atmospheric pressure.

[0417] According to one embodiment, the control device is further configured to receive a pressure signal from a pressure sensor placed outside the patient's body and to compare the measured pressure with the pressure received in the pressure signal.

[0418] According to one embodiment, the control device is configured to increase the pressure in a first and / or second implantable hydraulic constriction element based on the measured pressure.

[0419] According to one embodiment, the control device is configured to increase the pressure in a first and / or second implantable hydraulic constriction element up to a specified cross-sectional distance.

[0420] According to one embodiment, the coating comprises at least one layer of biomaterial.

[0421] According to one embodiment, the biomaterial comprises at least one drug or substance having antithrombotic and / or antibacterial and / or antiplatelet properties.

[0422] According to one embodiment, the biomaterial is fibrin-based.

[0423] According to one embodiment, the plantable pump device further comprises a second coating disposed on a first coating.

[0424] According to one embodiment, the second coating is a different biomaterial from the first coating.

[0425] According to one embodiment, the first coating comprises a perfluorocarbon layer chemically attached to the surface. The second coating comprises a liquid perfluorocarbon layer.

[0426] According to one embodiment, the coating comprises a drug encapsulated in a porous material.

[0427] According to one embodiment, the surface is made of metal.

[0428] According to one embodiment, the metal includes at least one selected from titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin, or lead.

[0429] According to one embodiment, the surface is provided with a micropattern.

[0430] According to one embodiment, the micropattern is etched onto the surface before being inserted into the body.

[0431] According to one embodiment, the implantable pump device further comprises a layer of biomaterial coated on a micropattern.

[0432] According to one embodiment, the connecting portion includes a flange constituting a fourth cross-sectional area, which is configured to prevent movement through the holes in the tissue portion in directions perpendicular to the first, second, and third planes.

[0433] According to one embodiment, the flange protrudes in a direction parallel to the first, second, third, and fourth planes and perpendicular to the central extension of the connecting portion.

[0434] According to one embodiment, the flange comprises a third surface configured to engage with a first tissue surface on the first side of the tissue portion.

[0435] According to one embodiment, the connecting portion comprises at least one protruding element constituting a fourth cross-sectional area, the at least one protruding element being configured to prevent movement through a hole in the tissue portion, thereby ensuring that the second portion and the connecting portion remain in place by the patient's tissue portion even when the first portion is detached from the connecting portion.

[0436] According to one embodiment, at least one protruding element protrudes in a direction parallel to the first, second, third, and fourth planes and perpendicular to the central extension of the connecting portion.

[0437] According to one embodiment, at least one protruding element comprises a third surface configured to engage with a first tissue surface on a first side of the tissue portion.

[0438] According to the embodiment, the connecting portion comprises at least two protruding elements that constitute a fourth cross-sectional area.

[0439] According to one embodiment, at least two protruding elements are arranged symmetrically with respect to the central axis of the connecting portion.

[0440] According to one embodiment, at least two protruding elements are arranged asymmetrically with respect to the central axis of the connecting portion.

[0441] According to the embodiment, at least one of the first, second, and third surfaces comprises at least one of ribs, barbs, hooks, friction-enhancing surface treatments, and friction-enhancing materials to facilitate the implantable electrically charged medical device being held in place by the tissue portion.

[0442] According to one embodiment, the connecting portion includes a hollow portion.

[0443] According to one embodiment, the hollow portion provides a passage between the first portion and the second portion.

[0444] According to the embodiment, the first part is detachably connected to the connecting part by at least one of a mechanical connection and a magnetic connection.

[0445] According to one embodiment, the first part is detachably connected to the connecting portion by at least one of threads and corresponding grooves, screws, self-locking elements, twist-locking joints, and spring-loaded locking mechanisms.

[0446] According to one embodiment, at least one protruding element has a height in a direction perpendicular to the fourth plane that is smaller than the height of the first portion in that direction.

[0447] According to one embodiment, at least one protruding element has a height in the direction perpendicular to the fourth plane that is less than half the height of the first portion in that direction.

[0448] According to one embodiment, at least one protruding element has a height in the direction perpendicular to the fourth plane that is less than one-quarter of the height of the first portion in that direction.

[0449] According to one embodiment, at least one protruding element has a height in the direction perpendicular to the fourth plane that is less than one-tenth of the height of the first portion in that direction.

[0450] According to one embodiment, at least one protruding element has a diameter in the fourth plane that is smaller than the diameter of the first portion in the first plane, equal to the diameter of the first portion in the first plane, and larger than the diameter of the first portion in the first plane.

[0451] According to one embodiment, at least one protruding element has a cross-sectional area in the fourth plane that is smaller than the cross-sectional area of ​​the first portion in the first plane, equal to the cross-sectional area of ​​the first portion in the first plane, and larger than the cross-sectional area of ​​the first portion in the first plane.

[0452] According to one embodiment, at least one protruding element has a height in the direction perpendicular to the fourth plane that is less than half the height of the connecting portion in that direction.

[0453] According to one embodiment, at least one protruding element has a height in the direction perpendicular to the fourth plane that is less than one-quarter of the height of the connecting portion in that direction.

[0454] According to one embodiment, at least one protruding element has a height in the direction perpendicular to the fourth plane that is less than one-tenth of the height of the connecting portion in that direction.

[0455] According to one embodiment, the first part comprises a first radio energy receiver configured to receive energy wirelessly transmitted from an external radio energy transmitter.

[0456] According to one embodiment, the first part constitutes an internal wireless energy transmitter.

[0457] According to one embodiment, the second part constitutes a second wireless energy receiver.

[0458] According to one embodiment, the first part constitutes a first energy storage unit.

[0459] According to the embodiment, the second part constitutes a second energy storage unit.

[0460] According to the embodiment, at least one of the first and second energy storage units is a solid-state battery.

[0461] According to one embodiment, the solid-state battery is a thionyl chloride battery.

[0462] According to one embodiment, a first wireless energy receiver is configured to receive energy wirelessly transmitted by an external wireless energy transmitter and store the received energy in a first energy storage unit. An internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to a second wireless energy receiver. A second wireless energy receiver is configured to receive energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in a second energy storage unit.

[0463] According to one embodiment, the first part comprises a first control device including at least one processing unit.

[0464] According to one embodiment, the second part comprises a second control device including at least one processing unit.

[0465] According to one embodiment, at least one of the first and second control devices is connected to a wireless transceiver for wireless communication with an external device.

[0466] According to the embodiment, the first control device is connected to a first wireless communication receiver in the first part in order to receive wireless communication from an external device. The first control device is connected to a first wireless communication transmitter in the first part in order to transmit wireless communication to a second wireless communication receiver in the second part.

[0467] According to one embodiment, the second control device is connected to a second wireless communication receiver for receiving wireless communications from the first part.

[0468] According to one embodiment, the first radio energy receiver comprises a first coil, and the internal radio energy transmitter comprises a second coil.

[0469] According to one embodiment, the first part comprises a composite coil, which is configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit the energy to a second wireless receiver in the second part.

[0470] According to one embodiment, at least one of the coils is embedded in a ceramic material.

[0471] According to one embodiment, the medical device further comprises a housing configured to enclose at least a first portion. The first portion of the housing is made of titanium, and the second portion of the housing is made of a ceramic material.

[0472] According to one embodiment, a portion of the housing made from a ceramic material consists of at least one coil embedded in the ceramic material.

[0473] According to one embodiment, the medical device further comprises a housing configured to enclose at least a second portion. The first portion of the housing is made of titanium, and the second portion of the housing is made of a ceramic material.

[0474] According to one embodiment, the medical device further comprises at least one sensor for providing input to at least one of the first and second control devices.

[0475] According to one embodiment, the sensor is configured to sense the physical parameters of an implantable electrically charged medical device.

[0476] According to one embodiment, the sensor is configured to sense at least one of the following: the temperature of an implantable electrostatic medical device or body engagement part; parameters relating to the power consumption of the implantable electrostatic medical device or body engagement part; parameters relating to the state of at least one of the first and second energy storage units; parameters relating to the radio transmission of energy from an external energy source to the patient's body; and hydraulic pressure.

[0477] According to one embodiment, the sensor is configured to sense the physiological parameters of a patient.

[0478] According to one embodiment, the sensor is configured to sense at least one of the following: parameters related to a patient's swallowing, local temperature, whole-body temperature, blood saturation, blood oxygenation, blood pressure, parameters related to ischemia markers, and pH.

[0479] According to one embodiment, a sensor configured to sense parameters related to a patient's swallowing comprises at least one of a motion sensor, an acoustic sensor, an optical sensor, and a strain sensor.

[0480] According to one embodiment, a sensor configured to sense pH is configured to sense the acidity in the stomach.

[0481] According to one embodiment, the control device is configured to transmit information based on sensor input to a device outside the patient's body.

[0482] According to the embodiment, the second portion constitutes at least part of an operating device for operating an implantable body engagement portion.

[0483] According to one embodiment, the second part consists of at least one electric motor.

[0484] According to one embodiment, the second part comprises a transmission configured to reduce the speed of motion and increase the force generated by the electric motor.

[0485] According to one embodiment, the transmission is configured to transmit high-speed torque to low-speed, strong torque.

[0486] According to one embodiment, the transmission is configured to convert rotational force into linear force.

[0487] According to one embodiment, the transmission is composed of a gear system.

[0488] According to one embodiment, the second part includes a magnetic coupling for transmitting mechanical work from an electric motor via a barrier separating the first chamber of the second part from the second chamber of the second part, or a housing surrounding at least the second part.

[0489] According to one embodiment, the second part comprises at least one hydraulic pump.

[0490] According to one embodiment, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0491] According to one embodiment, the medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to an electric motor. The capacitor is charged by at least one of the first and second energy storage units and is configured to supply power to the electric motor.

[0492] According to one embodiment, at least one of the first and second parts includes a sensory generator adapted to produce a sensation detectable by the patient's senses.

[0493] According to one embodiment, the second part comprises a force transmission element configured to mechanically transmit force from the second part to the implant engagement part.

[0494] According to one embodiment, the second part comprises a force transmission element configured to transmit force from the second part to the implant engagement part by hydraulic pressure.

[0495] According to one embodiment, the second part comprises at least one lead for transmitting electrical energy and / or information to a body engagement portion transplanted from the second part.

[0496] According to one embodiment, the first part is provided with an injection port for injecting fluid into the first part.

[0497] According to one embodiment, the connecting portion includes a conduit for transferring fluid from the first portion to the second portion.

[0498] According to one embodiment, the conduit is arranged to extend through the hollow portion of the connecting part.

[0499] According to one embodiment, the second part comprises a first chamber and a second chamber separated from each other. The first chamber contains a first fluid, and the second chamber contains a second fluid. The second fluid is a hydraulic fluid configured to transmit force to an implantable element configured to exert force on a part of the patient's body.

[0500] According to one embodiment, the wall portion of the first chamber has elasticity that allows the first chamber to expand.

[0501] According to one embodiment, the second part comprises a first hydraulic system in fluid communication with a first hydraulically actuated implant element configured to exert force on a part of the patient's body, and a second hydraulic system in fluid communication with a second hydraulically actuated implant element configured to exert force on a part of the patient's body, wherein the first and second hydraulically actuated implant elements are independently adjustable.

[0502] According to one embodiment, the first hydraulic system comprises a first hydraulic pump, and the second hydraulic system comprises a second hydraulic pump.

[0503] According to one embodiment, each of the first and second hydraulic systems includes a reservoir for holding a hydraulic fluid.

[0504] According to one embodiment, the medical device further comprises a first pressure sensor configured to sense pressure in a first hydraulic system and a second pressure sensor configured to sense pressure in a second hydraulic system.

[0505] According to one embodiment, the first surface is configured to engage with the first tissue surface on the first side of the tissue portion.

[0506] According to one embodiment, the first, second, and third planes are parallel to the main elongation planes of the tissue.

[0507] According to one embodiment, the fourth plane is parallel to the main elongation plane of the tissue.

[0508] According to one embodiment, the transmission member is configured to transmit mechanical force from the second part to the body engagement part.

[0509] According to one embodiment, the transmission member is configured to transmit fluid pressure from the second portion to the body engagement portion.

[0510] According to one embodiment, the transmission member is configured to transmit electrical energy force from the second part to the body engagement part.

[0511] According to the embodiment, the transfer member is configured to transfer data between the second part and the body engagement part.

[0512] According to one embodiment, the step of positioning the transport member comprises positioning the transport member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall such that at least half of the length of the transport member is positioned outside the patient's peritoneum.

[0513] According to one embodiment, the step of positioning the transport member comprises positioning the transport member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall such that at least two-thirds of the length of the transport member is positioned outside the patient's peritoneum.

[0514] According to one embodiment, the step of positioning the transport member comprises positioning the transport member completely outside the patient's peritoneum.

[0515] According to one embodiment, the step of positioning the transport member comprises positioning the transport member so that it extends from a second portion to the region outside the peritoneum, between the patient's thoracic cavity and the peritoneum.

[0516] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member so as to extend from the second portion to the subperitoneal space outside the peritoneum.

[0517] According to one embodiment, the step of positioning the transport member comprises positioning the transport member outside the peritoneum, extending from the second portion to the bladder.

[0518] According to one embodiment, the step of positioning the transport member comprises positioning the transport member outside the peritoneum, extending from a second portion to the urethra.

[0519] According to one embodiment, the step of positioning a second portion of an implantable electrocautery medical device between the peritoneum and the layers of abdominal wall muscle tissue comprises positioning the second portion between the first and second layers of abdominal wall muscle tissue.

[0520] According to one embodiment, the step of arranging the second part comprises arranging the second part which includes an electric motor.

[0521] According to one embodiment, the step of arranging the second part comprises arranging the second part which includes a hydraulic pump.

[0522] According to one embodiment, the step of arranging the second part comprises arranging the second part that constitutes the energy storage unit.

[0523] According to one embodiment, the step of arranging a second part comprises arranging a second part which includes a receiver for wirelessly receiving at least one of energy and communication.

[0524] According to one embodiment, the step of arranging the first part comprises arranging the first part which includes a transmitter for wirelessly transmitting at least one of energy and communication.

[0525] According to one embodiment, the step of arranging the second part comprises arranging the second part which constitutes a control device involved in the control of an electrically charged medical device.

[0526] According to the embodiment, the second portion is elongated and has a length axis that extends substantially in the elongated direction of the second portion. The step of positioning the second portion includes positioning the second portion such that the length axis is substantially parallel to the patient's craniocaudal axis.

[0527] According to one embodiment, the second portion is elongated and has a long axis substantially extending in the elongated direction of the second portion. The step of positioning the second portion includes positioning the second portion such that its long axis is substantially perpendicular to the patient's craniocaudal axis.

[0528] According to one embodiment, the second portion is elongated and has a major axis substantially extending in the elongated direction of the second portion. The step of positioning the second portion includes making a hole in the layer of muscular tissue of the stomach wall in the direction of the longitudinal axis of the second portion, and then oscillating or angling the second portion after the hole has been made.

[0529] According to one embodiment, the step of positioning a first portion of an implantable electrostatic medical device between the patient's skin and the layers of muscle tissue of the abdominal wall comprises positioning the first portion in the subcutaneous tissue.

[0530] According to one embodiment, the step of positioning a first portion of an implantable electrostatic medical device between the patient's skin and the layers of abdominal wall muscle tissue comprises positioning the first portion between a first layer and a second layer of abdominal wall muscle tissue.

[0531] According to one embodiment, the step of arranging the first part comprises arranging the first part that constitutes the energy storage unit.

[0532] According to one embodiment, the step of arranging the first part comprises arranging the first part which includes a receiver for wirelessly receiving at least one of energy and communication.

[0533] According to one embodiment, the step of arranging the first part comprises arranging the first part which includes a transmitter for wirelessly transmitting at least one of energy and communication.

[0534] According to one embodiment, the step of arranging the first part comprises arranging the first part which constitutes a control device involved in the control of an electrically charged medical device.

[0535] According to the embodiment, the first portion is elongated and has a long axis substantially extending in the elongated direction of the first portion. The step of positioning the first portion includes positioning the first portion such that its long axis is substantially parallel to the patient's craniocaudal axis.

[0536] According to the embodiment, the first portion is elongated and has a long axis substantially extending in the elongated direction of the first portion. The step of positioning the first portion includes positioning the first portion such that its long axis is substantially perpendicular to the patient's craniocaudal axis.

[0537] According to one embodiment, the first portion is elongated and has a first longitudinal axis substantially extending in the direction of extension of the first portion. The second portion is elongated and has a second longitudinal axis substantially extending in the direction of extension of the second portion. The step of arranging the first portion and the second portion comprises arranging the first portion and the second portion such that the longitudinal axes of the first portion and the longitudinal axis of the second portion are arranged at an angle greater than 30° with respect to each other.

[0538] According to one embodiment, the step of arranging the first part and the second part comprises arranging the first part and the second part such that the length axes of the first part and the length axes of the second part are arranged at an angle greater than 45° with respect to each other.

[0539] According to one embodiment, a method for implanting an electrically conductive medical device further includes the step of positioning a connecting portion through at least one layer of muscle tissue in the abdominal wall.

[0540] According to the embodiment, the first part, the second part, and the connecting part are parts of a single unit.

[0541] According to one embodiment, a method for implanting an electrically charged medical device further includes the step of connecting a first portion in place to a connecting portion.

[0542] According to one embodiment, a method for implanting an electrically charged medical device further includes the step of connecting a second portion in situ to a connecting portion.

[0543] According to one embodiment, the method for implanting an electrically charged medical device further includes the step of connecting a transfer member to a first part.

[0544] According to one embodiment, the method for implanting an electrically charged medical device further includes the step of connecting a transport member to a body engagement portion.

[0545] According to one embodiment, the body engagement portion includes a medical device for stretching the stomach wall to induce a feeling of fullness.

[0546] According to one embodiment, the body engagement portion includes a stenosis device configured to narrow the patient's tubular organ.

[0547] According to one embodiment, the body engagement portion includes an implantable constriction device.

[0548] According to one embodiment, the implantable stenosis device comprises an implantable stenosis device for narrowing a patient's tubular organ.

[0549] According to one embodiment, the body engagement portion includes an implantable element for actively emptying the patient's bladder.

[0550] According to one embodiment, an implantable element for actively emptying a patient's bladder is configured to empty the patient's bladder by compressing it from the outside.

[0551] According to one embodiment, the body engagement portion includes an element for electrically stimulating a tissue portion of the patient.

[0552] According to one embodiment, the first wireless transceiver is composed of a UWB transceiver.

[0553] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of supplying power to an energy-consuming component of an implantable medical device and charging an implantable energy storage unit.

[0554] According to one embodiment, the second network protocol is a standard network protocol. The standard network protocol may be one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0555] According to one embodiment, the second wireless transceiver is comprised of a Bluetooth transceiver.

[0556] According to one embodiment, the external device is further configured to communicate with the second external device using the at least one wireless transceiver.

[0557] According to one embodiment, the external device is configured to determine the distance between the external device and the implantable medical device by determining the RSSI.

[0558] According to one embodiment, the communication range of the first network protocol is smaller than the communication range of the second network protocol.

[0559] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0560] According to one embodiment, the external device is configured to authenticate an implantable medical device when the determined distance between the external device and the implantable medical device is less than a predetermined threshold.

[0561] According to one embodiment, the external device is configured to enable data transfer between the external device and the implantable medical device after the implantable medical device has been authenticated.

[0562] According to one embodiment, the external device is one selected from a wearable external device and a handset.

[0563] According to one embodiment, the first wireless transceiver is composed of a UWB transceiver.

[0564] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of supplying power to an energy-consuming component of an implantable medical device and charging an implantable energy storage unit.

[0565] According to one embodiment, the second network protocol is a standard network protocol selected from the list of radio frequency protocols, RFID protocols, WLAN protocols, Bluetooth protocols, BLE protocols, NFC protocols, 3G / 4G / 5G protocols, and GSM protocols.

[0566] According to one embodiment, the second wireless transceiver is comprised of a Bluetooth transceiver.

[0567] According to one embodiment, the implantable medical device is further configured to communicate with a second external device using the at least one wireless transceiver.

[0568] According to one embodiment, the implantable medical device is configured to determine the distance between the external device and the implantable medical device by determining the RSSI.

[0569] According to one embodiment, the communication range of the first network protocol is smaller than the communication range of the second network protocol.

[0570] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0571] According to one embodiment, the implantable medical device is configured to authenticate the external device when the determined distance between the external device and the implantable medical device is less than a predetermined threshold.

[0572] According to one embodiment, the implantable medical device is configured to enable data transfer between the implantable medical device and the external device after the external device has been authenticated.

[0573] According to one embodiment, an implantable medical device comprises at least one of the following: an external cardiac compression device, a device to assist the pumping function of the patient's heart, a device to assist the pumping function of the heart with a turbine bump placed in the patient's blood vessels to assist the pumping function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing blood flow to the coronary arteries, an implantable drug delivery device, an implantable drug delivery device for direct injection into a blood vessel and for changing the location of the injection site, an implantable drug delivery device for injecting potency-enhancing drugs into the patient's erectile tissue, all from within the patient's body, a hydraulic, mechanical, and / or electrical stenosis implant, an operable volumetric filling device, an operable gastric band, an operable implant for stretching the patient's stomach wall to create a feeling of fullness, an implant configured to sense how often the patient eats food, an operable cosmetic implant, an operable cosmetic implant for adjusting the shape and / or size of the patient's breast area, an implant for controlling a medical device for emptying the bladder, an implant to prevent urinary incontinence, an implant to prevent rectal incontinence, an implant to control the expulsion of feces Implants to monitor aneurysms, implants to prevent aneurysm dilation, implants to lubricate joints, implants to affect blood flow to a patient's erectile tissue, implants to simulate erectile tissue filling, implants with reservoirs to retain bodily fluids, implants to store and / or empty bodily fluid reservoirs or surgically fabricated reservoirs, implants to communicate with an external database, implants programmable from outside the body, implants programmable from outside the body via wireless signals, implants to treat impotence, implants to control the flow of eggs in the uterine duct, implants to control the flow of sperm in the uterine duct, implants to control the flow of sperm in the vas deferens, implants to obstruct sperm transport in the vas deferens, implants to treat osteoarthritis, implants to test internal parameters, implants to control specific therapeutic parameters from inside the body, implants to control bodily parameters from inside the body, implants to control blood pressure, implants to control blood pressure by affecting renal artery dilation, implants to control drug therapy parameters,Implants that control parameters in the blood; implants that adjust or replace bone portions of a patient's body; implants that replace a patient's organs or parts of organs or their functions; vascular treatment devices; implants adapted to move fluids within a patient's body; implants configured to sense parameters related to a patient's swallowing; implants configured to move muscles with electrical or mechanical stimulation; implants configured to empty portions of the intestines upon command; operable implants configured to be inserted into a patient's stomach to substantially reduce the stomach's volume to less than the device's volume; implants configured to compress the bladder to empty it from the patient's body; implants configured to drain fluids from a patient's body; implants configured to actively lubricate joints with added lubricants; implants configured to remove thrombi and particles from a patient's bloodstream; implants configured to lengthen or correct a patient's bones to alleviate scoliosis; devices that intensively stimulate the brain from several locations; artificial stomachs that replace the function of the natural stomach; implants configured to adjust the position of the female urinary tract or bladder neck; implants configured to stimulate the ampulla to cause temporary stenosis.

[0574] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0575] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0576] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0577] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0578] According to one embodiment, the system comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0579] According to one embodiment, the wireless communication unit comprises a wireless transceiver for wirelessly transmitting control commands to an implantable medical device and for wirelessly transmitting a control interface as a remote display portal to a patient display device.

[0580] According to one embodiment, the wireless communication unit comprises a first wireless transceiver for wirelessly transmitting control commands to an implantable medical device and a second wireless transceiver for wirelessly transmitting a control interface to a patient display device.

[0581] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with a patient display device using a standard network protocol.

[0582] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with an implantable medical device using a proprietary network protocol.

[0583] According to one embodiment, the wireless communication unit consists of a Bluetooth transceiver.

[0584] According to one embodiment, at least one of the first and second wireless transceivers is comprised of a Bluetooth transceiver.

[0585] According to one embodiment, the wireless communication unit is composed of a UWB transceiver.

[0586] According to one embodiment, at least one of the first and second wireless transceivers is configured as a UWB transceiver.

[0587] According to one embodiment, the wireless communication unit comprises at least one first wireless transceiver configured to communicate with the implantable medical device using a first network protocol to determine the distance between the patient external device and the implantable medical device, and at least one second wireless transceiver configured to communicate with the implantable medical device using a second network protocol to transfer data between the patient external device and the implantable medical device.

[0588] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of supplying power to an energy-consuming component of an implantable medical device and charging an implantable energy storage unit.

[0589] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0590] According to one embodiment, the communication range of the first wireless transceiver is smaller than the communication range of the second wireless transceiver.

[0591] According to one embodiment, the external patient device is configured to authenticate the implantable medical device when the distance between the external patient device and the implantable medical device is less than a predetermined threshold, or the external patient device is configured to be authenticated by the implantable medical device when the distance between the external patient device and the implantable medical device is less than a predetermined threshold, or the external patient device is configured to authenticate the patient display device when the distance between the external patient device and the patient display device is less than a predetermined threshold, or the external patient device is configured to be authenticated by the implantable medical device when the distance between the external patient device and the patient display device is less than a predetermined threshold.

[0592] According to one embodiment, the patient external device is configured to enable data transfer between the patient external device and an implantable medical device, and between the patient external device and at least one of the patient display devices, based on authentication.

[0593] According to one embodiment, the arithmetic unit is configured to encrypt at least one of the control interface and the control commands.

[0594] According to one embodiment, the implantable medical device comprises at least one of the following: an external cardiac compression device; a device for assisting the pumping function of the patient's heart; a device for assisting the pumping function of the heart, which includes a turbine bump placed in the patient's blood vessels to assist the pumping function of the heart; an operable artificial heart valve; and an operable artificial heart valve for increasing blood flow to the coronary arteries. Implantable drug delivery devices, implantable drug delivery devices for direct injection into blood vessels from within the patient's body and for changing the location of the injection site, implantable drug delivery devices for injecting potency enhancers into the patient's erectile tissue, hydraulic, mechanical, and / or electrical stenosis implants, operable volumetric filling devices, operable gastric bands, operable implants for stretching the patient's stomach wall to induce satiety, implants configured to sense how often the patient eats, operable cosmetic implants, operable cosmetic implants for adjusting the shape and / or size of the patient's breast area, implant-controlled medical devices for emptying the bladder, implants to prevent urinary incontinence, implants to prevent rectal incontinence, implants to control fecal excretion, implants to monitor aneurysms, implants to prevent aneurysm dilation, implants to lubricate joints, implants to affect blood flow to the patient's erectile tissue, erectile tissue Implants that simulate stenosis, implants with reservoirs that hold bodily fluids, implants that store and / or empty internal or surgically created reservoirs, implants that communicate with an external database, implants that are programmable from outside the body, implants that are programmable from outside the body via wireless signals, implants that treat impotence, implants that control the flow of eggs in the uterine duct, implants that control the flow of sperm in the uterine duct, implants that control the flow of sperm in the vas deferens, implants to obstruct sperm transport in the vas deferens, implants that treat osteoarthritis, implants that perform tests on internal parameters, implants that control specific therapeutic parameters from inside the body, implants that control bodily parameters from inside the body, implants that control blood pressure, implants that control blood pressure by affecting the dilation of the renal arteries, implants that control drug therapy parameters,Implants that control parameters in the blood; implants that adjust or replace bone portions of a patient's body; implants that replace organs or parts of organs or their functions; vascular treatment devices; implants adapted to move fluids within a patient's body; implants configured to sense parameters related to a patient's swallowing; implants configured to move muscles through electrical or mechanical stimulation; implants configured to empty portions of the intestines on command; operable implants configured to be inserted into a patient's stomach to substantially reduce the volume of the stomach to less than the volume of the device; implants configured to empty the bladder from a patient's body by compressing it; implants configured to drain fluids from a patient's body; implants configured to actively lubricate joints with added lubricants; implants configured to remove thrombi and particles from a patient's blood flow; implants configured to lengthen or correct a patient's bones to alleviate scoliosis; devices that intensively stimulate the brain from several locations; artificial stomachs that replace the function of the natural stomach; implants configured to adjust the position of the female urinary tract or bladder neck; implants configured to stimulate the ampulla to cause temporary stenosis.

[0595] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0596] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0597] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0598] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0599] According to one embodiment, the system comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0600] According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit. The auxiliary wireless communication unit is configured to be deactivated in order to enable at least one of the following: wirelessly receiving an implant control interface as a remote display portal from a patient remote external device, and wirelessly transmitting implant control user inputs to the patient remote external device.

[0601] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with a patient remote external device using a standard network protocol. The standard network protocol may be one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0602] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with a patient's remote external device using a proprietary network protocol.

[0603] According to one embodiment, the wireless communication unit consists of a Bluetooth transceiver.

[0604] According to one embodiment, the wireless communication unit is composed of a UWB transceiver.

[0605] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0606] According to one embodiment, the patient display device is configured to authenticate the patient remote external device when the distance between the patient display device and the patient remote external device is less than a predetermined threshold, or to be authenticated by the patient remote external device when the distance between the patient display device and the patient remote external device is less than a predetermined threshold.

[0607] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and the patient remote external device based on authentication.

[0608] According to one embodiment, the patient display device is an attachable external device or portable terminal.

[0609] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0610] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0611] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0612] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0613] According to one embodiment, the system comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0614] According to one embodiment, the arithmetic unit is configured to encrypt at least one of the control interface and the control commands.

[0615] According to one embodiment, the patient display device is configured to encrypt user input.

[0616] According to one embodiment, the server is configured to encrypt at least one of the user input received from the patient display device and the control interface received from the patient remote external device.

[0617] According to one embodiment, the computing unit is configured to encrypt the control interface, and the patient display device is configured to decrypt the encrypted control interface.

[0618] According to one embodiment, the server is configured to function as a router that transmits an encrypted control interface from a patient remote external device to a patient display device without decryption.

[0619] According to one embodiment of a communication system or patient display device, the implantable medical device comprises at least one of the following: an external cardiac compression device, a device for assisting the pumping function of the patient's heart, a device for assisting the pumping function of the heart, a turbine bump placed in the patient's blood vessels to assist the pumping function of the heart, an operable artificial heart valve, or an operable artificial heart valve for increasing blood flow to the coronary arteries. Implantable drug delivery devices, implantable drug delivery devices for direct injection into blood vessels from within the patient's body and for changing the location of the injection site, implantable drug delivery devices for injecting potency-enhancing drugs into the patient's erectile tissue, hydraulic, mechanical, and / or electrical stenosis implants, operable volumetric filling devices, operable gastric bands, operable implants for stretching the patient's stomach wall to induce satiety, implants configured to sense how often the patient eats food, operable cosmetic implants, operable cosmetic implants for adjusting the shape and / or size of the patient's breast area, implant-controlled medical devices for emptying the bladder, implants to prevent urinary incontinence, implants to prevent rectal incontinence, implants to control fecal excretion, implants to monitor aneurysms, implants to prevent aneurysm dilation, implants to lubricate joints, implants to affect blood flow to the patient's erectile tissue Implants, implants that simulate stenosis of erectile tissue, implants with reservoirs that hold bodily fluids, implants that store and / or empty internal or surgically created reservoirs, implants that communicate with an external database, implants that are programmable from outside the body, implants that are programmable from outside the body via wireless signals, implants that treat impotence, implants that control the flow of eggs in the uterine duct, implants that control the flow of sperm in the uterine duct, implants that control the flow of sperm in the vas deferens, implants to obstruct sperm transport in the vas deferens, implants that treat osteoarthritis, implants that perform tests on internal parameters, implants that control specific therapeutic parameters from inside the body, implants that control bodily parameters from inside the body, implants that control blood pressure, implants that control blood pressure by affecting the dilation of the renal arteries,Implants that control drug therapy parameters, implants that control parameters in the blood, implants that adjust or replace bone portions of a patient's body, implants that replace a patient's organ or part of an organ or its function, vascular treatment devices, implants adapted to move fluids within a patient's body, implants configured to sense parameters related to a patient's swallowing, implants configured to move muscles by electrical or mechanical stimulation, implants configured to empty portions of the intestines on command, operable implants configured to be inserted into a patient's stomach to substantially reduce the volume of the stomach to less than the volume of the device, implants configured to empty the bladder from a patient's body by compressing the bladder, implants configured to drain fluids from a patient's body, implants configured to actively lubricate joints with added lubricants, implants configured to remove thrombi and particles from a patient's bloodstream, implants configured to lengthen or correct a patient's bones to alleviate scoliosis, devices that intensively stimulate the brain from several locations, artificial stomachs that replace the function of the natural stomach, implants configured to adjust the position of the female urinary tract or bladder neck, implants configured to stimulate the ampulla to cause temporary stenosis.

[0620] According to one embodiment, the communication system further comprises a server. The server may include a wireless communication unit configured to wirelessly receive an implant control interface from a patient remote external device and to wirelessly transmit the implant control interface to a patient display device as a remote display portal. The wireless communication unit is further configured to wirelessly receive implant control user input from a patient EID external device and to wirelessly transmit the implant control user input to a patient display device.

[0621] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0622] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0623] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0624] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0625] According to one embodiment, the system comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0626] According to one embodiment, the initial login is a PIN-based login.

[0627] According to one embodiment, at least one of the first and second logins is a login based on biometric input or a hardware key.

[0628] According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit, which is configured to be deactivated in order to enable wireless communication with an external patient device.

[0629] According to one embodiment, the patient display device is configured to wirelessly receive an implant control interface, which serves as a remote display portal displayed on the display, from an external patient device.

[0630] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with an external patient device using a standard network protocol.

[0631] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with an external patient device using a proprietary network protocol.

[0632] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with an external patient device using a first network protocol and with a server using a second network protocol.

[0633] According to one embodiment, the wireless communication unit is configured to communicate wirelessly with an external patient device using a first frequency band and with a server using a second frequency band.

[0634] According to one embodiment, the wireless communication unit consists of a Bluetooth transceiver.

[0635] According to one embodiment, the wireless communication unit is composed of a UWB transceiver.

[0636] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0637] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0638] According to one embodiment, the wireless communication unit includes a first wireless transceiver for communicating with an external patient device and a second wireless transceiver for communicating with a server.

[0639] According to one embodiment, the second wireless transceiver is configured to be disabled in order to enable wireless communication using the first wireless transceiver.

[0640] According to one embodiment, the patient display device is configured to authenticate the patient external device when the distance between the patient display device and the patient external device is less than a predetermined threshold, or to be authenticated by the patient external device when the distance between the patient display device and the patient external device is less than a predetermined threshold.

[0641] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and an external patient device based on authentication.

[0642] According to one embodiment, the patient display device is an attachable external device or portable terminal.

[0643] According to one embodiment, a second application is configured to receive data related to the parameters of an implanted medical device.

[0644] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from an implanted medical device.

[0645] According to one embodiment, the second application is configured to receive data relating to at least one of the following parameters: battery status, temperature, time, and error.

[0646] According to one embodiment, the patient display device is configured to encrypt user input.

[0647] According to one embodiment, the display is configured to encrypt user input for decryption by an implantable medical device.

[0648] According to one embodiment, the patient display device is configured to decode a control interface received from an external patient device and display the control interface on a display.

[0649] According to one embodiment, at least one of the first and second applications is configured to receive data from an auxiliary external device and to present the received data to the user.

[0650] According to one embodiment, at least one of the first and second applications is configured to receive data from an auxiliary external device, including a scale for measuring the user's weight.

[0651] According to one embodiment, at least one of the first and second applications is configured to receive data relating to the user's weight from an auxiliary external device equipped with a weighing scale.

[0652] According to one embodiment, the patient display device is configured to wirelessly transmit data relating to the user's weight to an external patient device, to wirelessly transmit instructions derived from the data relating to the user's weight, or to wirelessly transmit instructions derived from a combination of data relating to the user's weight and implant control inputs received from the user.

[0653] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0654] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0655] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0656] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0657] According to one embodiment, the system includes a food sensor adapted to measure whether the patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of the medical device to trigger an action that extends the stomach after a determined amount of food has been ingested. According to one embodiment, the patient display device includes a first login function and a second login function, the first login function granting the user access to a first application, and a combination of the first and second login functions granting the user access to a second application.

[0658] According to one embodiment, a second application is configured to receive data related to the parameters of an implanted medical device.

[0659] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from an implanted medical device.

[0660] According to one embodiment, the second application is configured to receive data relating to at least one of the following parameters: battery status, temperature, time, and error.

[0661] According to one embodiment, the patient display device is configured to encrypt user input.

[0662] According to one embodiment, the display is configured to encrypt user input for decryption by an implantable medical device.

[0663] According to one embodiment, the patient remote external device is configured to function as a router that transmits encrypted user input from the patient display device to an implantable medical device without decryption.

[0664] According to one embodiment, the patient remote external device is configured to encrypt at least one of the control interface and the control commands.

[0665] According to one embodiment, the patient remote external device is configured to encrypt the control interface, and the patient display device is configured to decrypt the encrypted control interface.

[0666] According to one embodiment, a second application is configured to receive data related to the parameters of an implanted medical device.

[0667] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from an implanted medical device.

[0668] According to one embodiment, the second application is configured to receive data relating to at least one of the following parameters: battery status, temperature, time, and error.

[0669] According to one embodiment of the communication system, patient display device or computer program product of the present invention, an implantable medical device comprises at least one of the following: an external cardiac compression device, a device for assisting the pumping function of a patient's heart, a device for assisting the pumping function of a heart with a turbine bump placed in the patient's blood vessels to assist the pumping function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing blood flow to the coronary arteries, an implantable drug delivery device, an implantable drug delivery device for direct injection into a blood vessel from within the patient's body and for changing the location of the injection site, an implantable drug delivery device for injecting an enhancer into the patient's erectile tissue, a hydraulic, mechanical, and / or electrical stenosis implant, an operable volumetric filling device, an operable gastric band, an operable implant for stretching the patient's stomach wall to induce satiety, an implant configured to sense how often the patient eats food, an operable cosmetic implant, an operable cosmetic implant for adjusting the shape and / or size of the patient's breast area, an implant control physician for emptying the bladder Therapeutic devices, implants to prevent urinary incontinence, implants to prevent anal incontinence, implants to control fecal excretion, implants to monitor aneurysms, implants to prevent aneurysm dilation, implants to lubricate joints, implants to affect blood flow to a patient's erectile tissue, implants to simulate erectile tissue stenosis, implants with reservoirs to hold bodily fluids, implants to store and / or empty internal or surgically created reservoirs, implants to communicate with external databases, implants programmable from outside the body, implants programmable from outside the body via wireless signals, implants to treat impotence, implants to control the flow of eggs in the uterine duct, implants to control the flow of sperm in the uterine duct, implants to control the flow of sperm in the vas deferens, implants to obstruct sperm transport in the vas deferens, implants to treat osteoarthritis, implants to perform tests on internal parameters, implants to control specific therapeutic parameters from inside the body, implants to control bodily parameters from inside the body, implants to control blood pressure,Implants that control blood pressure by affecting the dilation of the renal arteries, implants that control drug therapy parameters, implants that control parameters in the blood, implants that adjust or replace bone portions of a patient's body, implants that replace organs or parts of organs or their functions, vascular treatment devices, implants adapted to move fluids within a patient's body, implants configured to sense parameters related to a patient's swallowing, implants configured to move muscles by electrical or mechanical stimulation, implants configured to empty portions of the intestines on command, operable implants configured to be inserted into a patient's stomach to substantially reduce the volume of the stomach to the volume of the device, implants configured to empty the bladder from a patient's body by compressing the bladder, implants configured to drain fluids from a patient's body, implants configured to actively lubricate joints with added lubricants, implants configured to remove thrombi and particles from a patient's blood flow, implants configured to lengthen or correct a patient's bones to alleviate scoliosis, devices that intensively stimulate the brain from several locations, artificial stomachs that replace the function of the natural stomach, implants configured to adjust the position of the female urinary tract or bladder neck, implants configured to stimulate the ampulla of blood vessels to cause temporary stenosis.

[0670] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0671] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0672] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0673] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0674] According to one embodiment, the system comprises a food sensor adapted to measure whether the patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0675] According to one embodiment, the patient display device is configured to wirelessly receive an implant control interface displayed on the display from an external patient device.

[0676] According to one embodiment, at least two of the following are configured for wireless communication using a standard network protocol: the server's wireless communication unit, the patient display device's wireless communication unit, the patient external device's wireless communication unit, and the implantable medical device's wireless communication unit.

[0677] According to one embodiment, at least two of the following are configured for wireless communication using a proprietary network protocol: a server's wireless communication unit, a patient display device's wireless communication unit, a patient external device's wireless communication unit, and an implantable medical device's wireless communication unit.

[0678] According to one embodiment, the wireless communication unit of the patient's external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with a server, or to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with a patient display device.

[0679] According to one embodiment, the wireless communication unit of the patient's external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with a server, or to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with a patient display device.

[0680] According to one embodiment, the wireless communication unit of the patient display device is configured to use a first network protocol for communication with an external patient device and a second network protocol for communication with a server.

[0681] According to one embodiment, the wireless communication unit of the patient display device is configured to use a first frequency band for communication with an external patient device and a second frequency band for communication with a server.

[0682] According to one embodiment, the server's wireless communication unit is configured to use a first network protocol for communication with an external patient device and a second network protocol for communication with a patient display device.

[0683] According to one embodiment, the server's wireless communication unit is configured to use a first frequency band for communication with an external patient device and a second frequency band for communication with a patient display device.

[0684] According to one embodiment, at least one wireless communication unit among a server, a patient display device, a patient external device, and an implantable medical device comprises a Bluetooth transceiver.

[0685] According to one embodiment, at least one wireless communication unit among a server, a patient display device, a patient external device, and an implantable medical device comprises a UWB transceiver.

[0686] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0687] According to one embodiment, the wireless communication unit of the patient external device comprises a first wireless transceiver for wirelessly communicating with an implantable medical device and a second wireless transceiver for wirelessly communicating with a server, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0688] According to one embodiment, the wireless communication unit of the external patient device comprises a first wireless transceiver for wireless communication with an implantable medical device and a second wireless transceiver for wireless communication with a patient display device, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0689] According to one embodiment, the wireless communication unit of the patient display device comprises a first wireless transceiver for wireless communication with an external patient device and a second wireless transceiver for wireless communication with a server, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0690] According to one embodiment, the second wireless transceiver has an effective range of any of the following: 2x, 4x, 8x, 20x, 50x, or 100x.

[0691] According to one embodiment, the second wireless transceiver is configured to be disabled in order to enable wireless communication using the first wireless transceiver.

[0692] According to one embodiment, the patient display device is configured to authenticate the external patient device when the distance between the patient display device and the external patient device is less than a predetermined threshold, or to be authenticated by the external patient device when the distance between the patient display device and the external patient device is less than a predetermined threshold, or to be authenticated by the implantable medical device when the distance between the patient display device and the implantable medical device is less than a predetermined threshold, or the external patient device is configured to be authenticated by the patient display device when the distance between the external patient device and the patient display device is less than a predetermined threshold, or to be authenticated by the patient display device when the distance between the external patient device and the patient display device is less than a predetermined threshold, or to be authenticated by the implantable medical device when the distance between the external patient device and the implantable medical device is less than a predetermined threshold.

[0693] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and an external patient device based on authentication.

[0694] According to one embodiment, the patient external device is configured to allow data transfer between the patient display device and the patient external device based on authentication.

[0695] According to one embodiment, the patient external device is configured to enable data transfer between the patient external device and an implantable medical device based on authentication.

[0696] According to one embodiment, the patient display device is a wearable external patient device or a portable terminal.

[0697] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of the following: battery status, temperature, time, and error.

[0698] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0699] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0700] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0701] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0702] According to one embodiment, the system comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0703] According to one embodiment, at least one of the patient secret key device or the HCP secret key device is composed of a hardware key.

[0704] According to one embodiment, the secret key device is at least one of a smart card, a key ring device, a wristwatch, a band on the arm or wrist, a necklace, or a device of any shape.

[0705] According to one embodiment of the system, at least two of the following are configured for wireless communication using a standard network protocol: an HCP EID external device, a patient EID external device, an HCP secret key device, a patient secret key device, and a DDI.

[0706] According to one embodiment, at least two of the HCP EID external device, patient EID external device, HCP secret key device, patient secret key device, and DDI are configured for wireless communication using a proprietary network protocol.

[0707] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and a second network protocol for communication with the DDI.

[0708] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with a DDI.

[0709] According to one embodiment, the DDI is configured to use a first frequency band for communication with the patient EID external device and a second frequency band for communication with the patient secret key device.

[0710] According to one embodiment, at least one of the HCP EID external device, patient EID external device, HCP private key device, patient private key device, and DDI includes a Bluetooth transceiver.

[0711] According to one embodiment, at least one of the HCP EID external device, patient EID external device, HCP private key device, patient private key device, and DDI is comprised of a UWB transceiver.

[0712] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0713] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with an implantable medical device and a second wireless transceiver for wireless communication with a DDI, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0714] According to one embodiment, the patient secret key device comprises a first wireless transceiver for wireless communication with an HCP EID external device and a second wireless transceiver for wireless communication with a DDI, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0715] According to one embodiment, the second wireless transceiver has an effective range which is one of the following: 2x, 4x, 8x, 20x, 50x, or 100x.

[0716] According to one embodiment, the second wireless transceiver is configured to be disabled in order to enable wireless communication using the first wireless transceiver.

[0717] According to one embodiment, the patient EID external device is configured to enable data transfer between the EID external device and an implantable medical device based on authentication of the patient EID external device.

[0718] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0719] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of the following: battery status, temperature, time, and error.

[0720] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0721] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0722] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0723] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0724] According to one embodiment, the system comprises a food sensor adapted to measure whether the patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0725] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with an implantable medical device via a second network protocol.

[0726] According to one embodiment, the HCP secret key device is adapted to be provided to at least one HCP external device via at least one of the following: a read slot or equivalent for the HCP secret key device, RFID communication, a near-field radio activation communication unit, or direct electrical contact.

[0727] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent for an HCP secret key device, an RFID communication and short-range wireless activation communication unit, or an electrical direct contact.

[0728] According to one embodiment, the HCP EID external device is adapted to receive commands from the HCP dedicated device to modify the pre-programmed treatment steps of the implantable medical device when implanted, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its secret key.

[0729] According to one embodiment, the HCP EID external device, the patient EID external device, the HCP secret key device, and at least two of the patient secret key devices are configured for wireless communication using a standard network protocol.

[0730] According to one embodiment, at least two of the HCP EID external device, patient EID external device, HCP secret key device, and patient secret key device are configured for wireless communication using a proprietary network protocol.

[0731] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with a patient secret key device.

[0732] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with a patient secret key device.

[0733] According to one embodiment, at least one of the HCP EID external device, patient EID external device, HCP secret key device, and patient secret key device is comprised of a Bluetooth transceiver.

[0734] According to one embodiment, the HCP EID external device, the patient EID external device, the HCP secret key device, and at least one of the patient secret key devices are composed of a UWB transceiver.

[0735] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0736] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with an implantable medical device and a second wireless transceiver for wireless communication with a patient secret key device, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0737] According to one embodiment, the second wireless transceiver has an effective range which is one of the following: 2x, 4x, 8x, 20x, 50x, or 100x.

[0738] According to one embodiment, the second wireless transceiver is configured to be disabled in order to enable wireless communication using the first wireless transceiver.

[0739] According to one embodiment, the patient EID external device is configured to enable data transfer between the EID external device and an implantable medical device based on authentication of the patient EID external device.

[0740] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0741] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of the following: battery status, temperature, time, and error.

[0742] According to one embodiment, a wireless transceiver, a remote display portal, and the remote display portal are configured within a patient remote external device.

[0743] According to one embodiment, the system further comprises a patient display device, which may include a support application, a display hosting a remote display portal, and a secret key for the patient display device.

[0744] According to one embodiment, the remote display portal can generate commands that are signed by the private key of the patient display device.

[0745] According to one embodiment, the patient remote external device is adapted to receive input from the patient via the patient display device through its remote display portal.

[0746] According to one embodiment, the patient remote external device consists of a graphical user interface arranged on a touch-responsive display that exposes buttons representing the operating functions of the transplant medical device.

[0747] According to one embodiment, the system is configured so that the patient can activate the implant at home via a remote external device, with authorization granted by the patient's secret key.

[0748] According to one embodiment, the patient's secret key consists of at least one of a smart card, a keychain device, a watch, an arm or wristband, a necklace, and a device of any shape.

[0749] According to one embodiment, the system is configured to allow the patient, upon implantation, to operate an implantable medical device at home via a remote external device using authorization granted by the patient's private key.

[0750] According to one embodiment, the system further comprises a patient EID external device including a read slot or equivalent for a patient secret key device, RFID communication, short-range wireless activation communication, or direct electrical contact.

[0751] According to one embodiment, the patient EID external device is adapted to synchronize with the patient remote external device.

[0752] According to one embodiment, the patient EID external device further comprises at least one of a patient, a wireless transceiver configured to communicate with a remote external device, and a wired connector for communicating with the patient remote external device.

[0753] According to one embodiment, the patient EID external device is adapted to generate authorization via the patient EID external device, which is signed by a patient secret key installed on at least one of the patient remote external devices and implantable medical devices.

[0754] According to one embodiment, the system includes a patient display device that includes a support application capable of displaying a remote display portal using content delivered from a remote external device for the patient.

[0755] According to one embodiment, the remote display portal and the patient remote external device are adapted to expose buttons for the patient to express their intention to activate the functions of an implantable medical device through the patient remote external device.

[0756] According to one embodiment, the patient display device comprises at least one of a display that hosts a remote display portal and a secret key for the patient display device.

[0757] According to one embodiment, the remote display portal can generate commands that are signed by the patient's secret key.

[0758] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can exchange and pair new patient secret key devices or HCP secret key devices with the system via an HCP EID external device.

[0759] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0760] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0761] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0762] According to one embodiment, the system comprises a food sensor adapted to measure whether the patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0763] According to one embodiment, at least one patient EID external device is adapted to receive information from the implant via a second network protocol.

[0764] According to one embodiment, the system comprises a DDI, where DDI1 is adapted to receive information from the patient EID external device, and the DDI comprises a wireless transceiver configured to communicate with the patient EID external device.

[0765] According to one embodiment, the patient EID external device is adapted to receive commands relayed by DDI, to further transmit commands to the transplant medical device to change the pre-programmed treatment settings of the transplant medical device, and is further adapted to be activated and authenticated by the patient providing a patient secret key and authorized to execute the commands.

[0766] According to one embodiment, the patient secret key device is adapted to allow the patient to provide the patient secret key to the patient EID external device via at least one of the following: a read slot or equivalent for the patient secret key device, RFID communication or other short-range radio activation communication, or direct electrical contact.

[0767] According to one embodiment, the patient EID external device comprises at least one of the following: a read slot or equivalent for an HCP secret key device, RFID communication, other short-range wireless activation communication, or direct electrical contact.

[0768] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with an implantable medical device via a second network protocol.

[0769] According to one embodiment, the system consists of an implantable medical device that, once implanted, can be adapted to treat a patient or perform physical functions.

[0770] According to one embodiment, the patient's secret key consists of at least one of a smart card, a keychain device, a watch, a bracelet or wristband, a necklace, and a device of any shape.

[0771] According to one embodiment, at least two of the patient EID external device, IDD, and patient secret key device are configured for wireless communication using a standard network protocol.

[0772] According to one embodiment, at least two of the patient EID external device, IDD, and patient secret key device are configured for wireless communication using a proprietary network protocol.

[0773] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with a patient secret key device.

[0774] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with a patient secret key device.

[0775] According to one embodiment, at least one of the patient EID external device, patient secret key device, and IDD is comprised of a Bluetooth transceiver.

[0776] According to one embodiment, at least one of the patient EID external device, patient secret key device, and IDD is comprised of a UWB transceiver.

[0777] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0778] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with an implantable medical device and a second wireless transceiver for wireless communication with a patient secret key device, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0779] According to one embodiment, the second wireless transceiver has an effective range which is one of the following: 2x, 4x, 8x, 20x, 50x, or 100x.

[0780] According to one embodiment, the second wireless transceiver is configured to be disabled in order to enable wireless communication using the first wireless transceiver.

[0781] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0782] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of the following: battery status, temperature, time, and error.

[0783] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted so that an HCP or HCP administrator can replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0784] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0785] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0786] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0787] According to one embodiment, the system comprises a food sensor adapted to measure whether the patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0788] According to one embodiment, at least one patient remote external device includes a patient remote external device secret key, and the DDI via the patient EID external device can deactivate the authorization and authentication functions of the patient remote external device, thereby deactivating the patient remote external device.

[0789] According to one embodiment, the patient EID external device comprises at least one wireless transceiver configured to communicate with DD1 via a first network protocol.

[0790] According to one embodiment, the system comprises a DDI, which is adapted to receive commands from an HCP EID external device and transmit the received commands to the patient EID external device, and the DDI comprises a wireless transceiver configured to communicate with the patient external device.

[0791] According to one embodiment, the patient EID external device is adapted to receive commands from the DDI, which are initiated by the healthcare provider (HCP), and the patient EID is adapted to deactivate the patient's private key and transmit the commands to the implantable medical device.

[0792] According to one embodiment, the patient EID external device is adapted to receive a command from a DDI, which originates from a healthcare provider (HCP), and the patient EID external device is adapted to receive a command from the HCP via the DDI to deactivate the patient remote external device, which consists of a patient remote external device secret key, and the patient EID external device is further adapted to transmit this command to an implantable medical device.

[0793] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with an implantable medical device via a second network protocol.

[0794] According to one embodiment, at least one of the patient's secret key and the patient's remote external device secret key is a hardware key.

[0795] According to one embodiment, the secret key device is at least one of a smart card, a key ring device, a wristwatch, a band on the arm or wrist, a necklace, or a device of any shape.

[0796] According to one embodiment, at least two of the patient remote external device, patient EID external device, patient secret key device, and DDI are configured for wireless communication using a standard network protocol.

[0797] According to one embodiment, at least two of the following are configured for wireless communication using a proprietary network protocol: a patient remote external device, a patient EID external device, a patient secret key device, and a DDI.

[0798] According to one embodiment, the patient EID external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with a patient secret key device.

[0799] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with a patient secret key device.

[0800] According to one embodiment, at least one of the patient remote external device, patient EID external device, patient secret key device, and DDI is comprised of a Bluetooth transceiver.

[0801] According to one embodiment, at least one of the patient remote external device, patient EID external device, patient secret key device, and DDI consists of a UWB transceiver.

[0802] According to one embodiment, the standard network protocol is one of the following: radio frequency protocol, RFID protocol, WLAN protocol, Bluetooth protocol, BLE protocol, NFC protocol, 3G / 4G / 5G protocol, and GSM protocol.

[0803] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wireless communication with an implantable medical device and a second wireless transceiver for wireless communication with a patient secret key device, wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.

[0804] According to one embodiment, the second wireless transceiver has an effective range which is one of the following: 2x, 4x, 8x, 20x, 50x, or 100x.

[0805] According to one embodiment, the second wireless transceiver is configured to be disabled in order to enable wireless communication using the first wireless transceiver.

[0806] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0807] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of the following: battery status, temperature, time, and error.

[0808] According to one embodiment, the system includes a master secret key device configured to enable the issuance of new secret key devices, and such master secret key device is adapted to allow an HCP or HCP administrator to replace and pair a new patient secret key device or HCP secret key device with the system via an HCP EID external device.

[0809] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0810] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0811] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0812] According to one embodiment, the system comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0813] According to one embodiment, the system includes a master private key device that enables the issuance of new private key devices, and an HCP or HCP administrator adapts such a master private key device so that it can be replaced with a new patient private key device or HCP private key device via an HCP EID external device and paired with the system.

[0814] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0815] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0816] According to one embodiment, the system further comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0817] According to one embodiment, the system further comprises a food sensor adapted to measure whether at least a patient is swallowing solid food or drinking liquid, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0818] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with an implantable medical device via a second network protocol.

[0819] According to one embodiment, the HCP secret key device is adapted to be provided to at least one HCP external device via at least one of the following: a read slot or equivalent for the HCP secret key device, RFID communication, a near-field radio activation communication unit, or direct electrical contact.

[0820] According to one embodiment, the HCP EID external device comprises at least one of the following: a read slot for an HCP secret key device or equivalent, RFID communication, a short-range wireless activation communication unit, or electrical direct contact.

[0821] According to one embodiment, the HCP EID external device is adapted to receive commands from the HCP dedicated device to modify the pre-programmed treatment steps of the implantable medical device when implanted, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its secret key.

[0822] According to one embodiment, the HCP EID external device and the HCP secret key device are configured for wireless communication using a standard network protocol.

[0823] According to one embodiment, the HCP EID external device and the HCP secret key device are configured for wireless communication using a proprietary network protocol.

[0824] According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with an HCP secret key device.

[0825] According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with an HCP secret key device.

[0826] According to one embodiment, at least one of the HCP EID external device and the HCP secret key device is composed of a Bluetooth transceiver.

[0827] According to one embodiment, at least one of the HCP EID external device and the HCP secret key device is composed of a UWB transceiver.

[0828] According to one embodiment, the HCP private key device comprising the HCP private key includes at least one of a smart card, a keychain device, a watch, an arm or wristband, a necklace, and a device of any shape.

[0829] According to one embodiment, the patient secret key device comprises a patient secret key comprising at least one of a smart card, a keychain device, a watch, an arm or wristband, a necklace, and a device of any shape.

[0830] According to one embodiment, the patient secret key is adapted to invoke, authenticate, and execute the command provided by the HCP when the action is performed remotely via the HCP EID external device or via the patient EID external device.

[0831] According to one embodiment, the system further comprises a dedicated data infrastructure, a DDI, a patient EID external device, and an HCP EID external device, and communication between the patient EID external device and the HCP EID external device is performed via the DDI.

[0832] According to one embodiment, the system comprises a master secret key device that enables the issuance of new secret key devices, and the HCP or HCP administrator has such a master secret key device adapted to replace and pair a new patient secret key device or HCP secret key device with the system.

[0833] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0834] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0835] According to one embodiment, the system further comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0836] According to one embodiment, the system comprises a food sensor adapted to measure whether a patient is swallowing solids or liquids, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0837] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with an implantable medical device via a second network protocol.

[0838] According to one embodiment, the HCP secret key device is adapted to be provided to at least one HCP external device via at least one of the following: a read slot or equivalent for the HCP secret key device, RFID communication, a near-field radio activation communication unit, or direct electrical contact.

[0839] According to one embodiment, the HCP EID external device comprises at least one of the following: a read slot for the HCP secret key device or equivalent, RFID communication, a short-range wireless activation communication unit, or electrical direct contact.

[0840] According to one embodiment, the HCP EID external device is adapted to receive commands from the HCP dedicated device to modify the pre-programmed treatment steps of the implantable medical device when implanted, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its secret key.

[0841] According to one embodiment, the HCP EID external device and the HCP secret key device are configured for wireless communication using a standard network protocol.

[0842] According to one embodiment, the HCP EID external device and the HCP secret key device are configured for wireless communication using a proprietary network protocol.

[0843] According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with an HCP secret key device.

[0844] According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with an HCP secret key device.

[0845] According to one embodiment, at least one of the HCP EID external device and the HCP secret key device is composed of a Bluetooth transceiver.

[0846] According to one embodiment, at least one of the HCP EID external device and the HCP secret key device is composed of a UWB transceiver.

[0847] According to one embodiment, at least one of the patient secret key device or the HCP secret key device is composed of a hardware key.

[0848] According to one embodiment, the secret key device is at least one of a smart card, a key ring device, a wristwatch, a band on the arm or wrist, a necklace, or a device of any shape.

[0849] According to one embodiment, the system comprises a master secret key device that enables the issuance of new secret key devices, and an HCP or HCP administrator adapts such a master secret key device so that it can be replaced with a new patient secret key device or HCP secret key device via an HCP EID external device and paired with the system.

[0850] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0851] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0852] According to one embodiment, the system comprises a measuring device or sensor adapted to supply measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0853] According to one embodiment, the system comprises a food sensor adapted to measure whether a patient is swallowing solids or liquids, the food sensor being connected to a control unit of a medical device to trigger an action that extends the stomach after a determined amount of food has been ingested.

[0854] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with an implantable medical device via a second network protocol.

[0855] According to one embodiment, the HCP secret key device is adapted to be provided to at least one HCP external device via at least one of the following: a read slot or equivalent for the HCP secret key device, RFID communication, a short-range radio activation communication unit, or direct electrical contact.

[0856] According to one embodiment, the HCP EID external device comprises at least one of the following: a read slot for the HCP secret key device or equivalent, RFID communication, a short-range wireless activation communication unit, or electrical direct contact.

[0857] According to one embodiment, the HCP EID external device is adapted to receive commands from the HCP dedicated device to modify the pre-programmed treatment steps of the implantable medical device when implanted, and the HCP dedicated device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing its secret key.

[0858] According to one embodiment, the HCP EID external device and the HCP secret key device are configured for wireless communication using a standard network protocol.

[0859] According to one embodiment, the HCP EID external device and the HCP secret key device are configured for wireless communication using a proprietary network protocol.

[0860] According to one embodiment, the HCP EID external device is configured to use a first network protocol for communication with an implantable medical device and a second network protocol for communication with an HCP secret key device.

[0861] According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with an implantable medical device and a second frequency band for communication with an HCP secret key device.

[0862] According to one embodiment, at least one of the HCP EID external device and the HCP secret key device is composed of a Bluetooth transceiver.

[0863] According to one embodiment, at least one of the HCP EID external device and the HCP secret key device is composed of a UWB transceiver.

[0864] Embodiments, parts of embodiments, methods, or parts of methods can be combined in any applicable manner.

[0865] An external system is further provided for providing remote instructions to an implantable medical device. This external system is configured to provide instructions to be transmitted to the implantable medical device, derive a checksum from the instructions, and digitally sign the instructions and checksum. The external system is further configured to form data packets from the instructions, digital signature, and checksum. The implantable medical device further comprises a wireless transmitter configured to wirelessly transmit the data packets to the implantable medical device. The external system may be further configured to encrypt the data packets in the external system. The checksum is configured to verify that no changes have been made to the bitstream forming the instructions.

[0866] According to one embodiment, the wireless transmitter is part of a wireless transceiver configured with an external system.

[0867] According to one embodiment, the external system comprises a first external device and a second external device, the first external device being configured to transmit data packets to the second external device, and the second external device being configured to wirelessly transmit data packets to an implantable medical device without modifying the data packets and / or without fully decoding the data packets.

[0868] The external system may be configured to send at least one instruction to the implantable medical device to modify the control program of the implantable medical device, the instruction may include modifying at least one parameter to affect the control of the implantable medical device, the parameter may include updating at least one parameter of the control program to a parameter value included in a set of parameter values ​​stored in the implantable medical device.

[0869] According to one embodiment, the first external device is configured to transmit data packets from the first external device to the second external device using a first network protocol, and to transmit data packets from the second external device to an implantable medical device using a second network protocol.

[0870] According to one embodiment, the first external device is configured to transmit data packets from the first external device to the second external device using wired communication, and to transmit data packets from the second external device to an implantable medical device using wireless communication.

[0871] According to one embodiment, the first external device is configured to wirelessly transmit data packets from the first external device to the second external device using a first network protocol, and to wirelessly transmit data packets from the second external device to an implantable medical device using a second network protocol.

[0872] According to one embodiment, the first external device is configured to wirelessly transmit data packets from the first external device to the second external device using a first frequency band, and to wirelessly transmit data packets from the second external device to an implantable medical device using a second frequency band.

[0873] According to one embodiment, the first external device is configured to wirelessly transmit data packets from the first external device to the second external device using the first wireless technology, and to wirelessly transmit data packets from the second external device to an implantable medical device using the second wireless technology.

[0874] According to one embodiment, the external system is configured to electronically sign instructions in the external system using a key of the external system. The key may be an unextractable key.

[0875] According to one embodiment, the second external device is configured to perform a proof of ownership operation which includes the steps of: sending a query from the first external device to the second external device based on a public key associated with the private of the external system; receiving a response in the second external device based on ownership of the private key in the first external device; and verifying that the response based on ownership of the private key matches the query based on the public key.

[0876] According to one embodiment, a first external device is configured to form a data packet and digitally sign the instruction using a first secret key, and a second external device is configured to receive the data packet from the first external device, verify that the first external device is a trusted transmitter, and in response to the verification, digitally sign the data packet using a second secret key and transmit the data packet from the second external device to a medical implant.

[0877] According to one embodiment, the first external device is configured to digitally sign instructions and encrypt data packets using keys stored in a key device outside the first external device. The external system may include a key device configured to hold at least one private key which is part of a public-private key pair used for asymmetric encryption.

[0878] According to one embodiment, the key device includes a wireless transmitter for wirelessly transmitting at least one secret key or a signal based on a secret key to a first external device. The second external device is configured to digitally sign instructions and encrypt data packets using a key located in the key device outside the second external device.

[0879] According to one embodiment, the external system further comprises a second key device configured to hold at least one second secret key, the second key device may comprise a wireless transmitter for wirelessly transmitting at least one secret key or a signal based on a secret key to the second external device.

[0880] According to one embodiment, 5. The external system further comprises a second key device including a wireless transmitter for wirelessly transmitting at least one second secret key or a signal based on the second secret key to the first external device.

[0881] According to one embodiment, at least one of the key device and the second key device comprises at least one of a key card, a wearable device, and a handset.

[0882] The first and / or second external devices may be configured to be unlocked by user credentials provided to the first external device. User credentials may consist of a username, password, and / or PIN code.

[0883] According to one embodiment, the first external device is configured to verify user credentials by comparing them with user credentials stored in the first external device. The user credentials may be stored in the first external device by the manufacturer of the first external device. The user credentials may be stored in the first external device as hardware or software.

[0884] According to one embodiment, the first external device is configured to verify user authentication information by communicating with a remote server.

[0885] In any embodiment of this specification, the external system may be configured to function without being connected to the Internet and to communicate with the implantable medical device regardless of time.

[0886] The first and second secret keys may be different in any embodiment, provided that the first and second secret keys include at least one common element. At least one first and second external device is configured to be unlocked by at least one of the first and second secret keys.

[0887] According to one embodiment, the external system comprises a central server, which is configured to form data packets from instructions, digital signatures, and checksums, and is further configured to provide the formed data packets to a first external device.

[0888] The central server can be accessed by at least one healthcare professional, who can provide input to the central server to form instructions to be sent to an implantable medical device.

[0889] At least one patient can access the central server, and the patient can provide input to the central server to verify at least one of the reliability of the healthcare provider and the accuracy of the instructions. Healthcare providers and / or patients can electronically sign instructions on the central server.

[0890] According to one embodiment, a central server is configured to verify the authenticity of the first and second keys and to electronically sign instructions using the first and second keys. The second key may be a user key, and an external system may be configured to use the second key for at least one of the following: authorizing that communications be sent to an implantable medical device, and authorizing that a healthcare provider prepare instructions for the implantable medical device.

[0891] According to one embodiment, the approval step can be performed by a first or second external device.

[0892] According to one embodiment, a first key is required to create instructions for an implantable medical device, and a second key is required to transmit the created instructions to the implantable medical device.

[0893] According to one embodiment, at least one of the first and second external devices includes an input button configured to be used to confirm the presence of a user.

[0894] According to one embodiment, the input button is configured to replace at least one of the input of at least one key to at least one of the first and second external devices, and at least one of the input of authentication information to at least one of the first and second external devices. The input button may also be configured to replace a second key.

[0895] According to one embodiment, an external system is configured to transmit data packets to an implantable medical device, the data packets comprising at least one instruction signed with a first key and a public key containing information about which root created the public key.

[0896] According to one embodiment, at least one of the first and second external devices may be configured to enable communication with an implantable medical device based on at least one password provided to at least one of the first and second external devices.

[0897] According to one embodiment, at least one of the first and second external devices is configured to enable communication with an implantable medical device based on two passwords provided to at least one of the first and second external devices.

[0898] According to one embodiment, at least one of the first and second external devices is configured to enable communication with an implantable medical device based on one patient password and one healthcare provider password provided to at least one of the first and second external devices.

[0899] According to one embodiment, at least one of the first and second external devices is configured to perform a verification query operation with at least one of the first and second key devices, the verification query operation including the steps of: sending a query including a computation challenge from the first or second external device to at least one of the first and second key devices; receiving a response in the first or second external device based on the transmitted computation challenge; and verifying the received response in the first or second external device. The verification query operation may take the form of a proof of ownership operation including: receiving a public key associated with the private key of the first or second key device in at least one of the first and second key devices; sending a computation challenge from at least one of the first and second external devices to the first or second key device based on the public key received from the first or second key device; receiving a response from the first or second key device based on ownership of the private key in the first or second key device; and verifying that the response based on ownership of the private key matches the query based on the public key.

[0900] Further provided are implantable medical devices configured to receive remote instructions from an external system. The implantable medical device comprises a radio receiver configured to receive data packets transmitted wirelessly from an external system, and an arithmetic unit configured to verify digital signatures and verify the integrity of instructions using checksums contained in the data packets. The arithmetic unit may further be configured to decode the data packets. The arithmetic unit may also be configured to use the checksums to verify that the bitstream constituting the instructions has not been altered.

[0901] A wireless receiver may be part of a wireless transceiver.

[0902] According to one embodiment, the computing unit may include a memory unit configured to store digital signatures, and the computing unit may be configured to verify digital signatures by comparing them with digital signatures stored in the memory unit.

[0903] According to one embodiment, an implantable medical device comprises a control program configured to control at least one function of the implantable medical device, and a computing unit may be configured to modify the control program based on received instructions.

[0904] According to one embodiment, an implantable medical device comprises an internal computing unit configured to execute a control program for controlling the functions of the implantable medical device. The control program may include at least one adjustable parameter that affects the control of the implantable medical device, and a method for providing remote instructions may include providing instructions for changing at least one parameter that affects the control of the implantable medical device.

[0905] According to one embodiment, an implantable medical device comprises a central unit including at least one of a wireless receiver and a wireless transceiver, and a security module connected to the central unit. The implantable medical device is configured to transfer data packets from the central unit to the security module, and the security module may be configured to perform at least part of at least one of decryption and signature verification.

[0906] The security module may include a set of rules for accepting communications from the central device, and the security module may be configured to verify compliance with the set of rules.

[0907] According to one embodiment, a wireless receiver or wireless transceiver may be configured to be in an off-mode so that it cannot receive wireless communications by the wireless transceiver, and the set of rules may include rules that specify that communications from the central unit are accepted by the security module only when the wireless transceiver is in the off-mode.

[0908] According to one embodiment, an implantable medical device may be configured to decrypt data packets and / or verify digital signatures using a private key of the implantable medical device. The private key may be an unextractable key. The private key may be provided to the implantable medical device by the manufacturer of the implantable medical device and may be stored in the implantable medical device as hardware or software.

[0909] According to one embodiment, an implantable medical device is configured to perform a proof of ownership operation which includes sending a query from the implantable medical device to an external system based on a public key associated with the private key of the external system, receiving a response from the implantable medical device based on ownership of the private key in the external system, and verifying that the response based on ownership of the private key matches the query based on the public key.

[0910] Implantable medical devices can be configured to communicate with external systems independently of time.

[0911] According to one embodiment, an implantable medical device is configured to: verify a first digital signature created using at least one of a first key and a second key, and verify a second digital signature created using at least one of the first key and a second key. At least one of the first and second keys may be a private key, the first and second keys may be different, and the first and second keys may contain at least one common element.

[0912] According to one embodiment, an implantable medical device is configured to verify a first digital signature to authorize communication from an external system to the implantable medical device, and to verify a second digital signature to authorize instructions received in the communication to modify a control program running on the implantable medical device.

[0913] According to one embodiment, the first electronic signature is linked to the user of the implantable medical device, and the second electronic signature is linked to the healthcare provider.

[0914] According to one embodiment, only a portion of the private key is required for at least one of decrypting the data packet and verifying the digital signature.

[0915] Implantable medical devices trust external devices that possess the secret key.

[0916] According to one embodiment, an implantable medical device is configured to receive a data packet containing at least one instruction signed by the private key of an external system, and a public key containing information about which route created the public key.

[0917] According to one embodiment, the implantable medical device is configured to accept communications from an external system based on at least one password provided to the implantable medical device. According to one embodiment, the implantable medical device is configured to accept communications from an external system based on two passwords provided to the implantable medical device.

[0918] According to one embodiment, an implantable medical device is configured to accept communication from an external system based on one patient password and one healthcare provider password provided to the implantable medical device.

[0919] A method for providing remote instructions to an implantable medical device from an external system is further provided. This method includes, in the external system, deriving a checksum from an instruction to be transmitted to the implantable medical device; electronically signing the instruction and checksum in the external system, wherein the instruction, checksum and electronic signature form a data packet; wirelessly transmitting the data packet to the implantable medical device; verifying the electronic signature; and verifying the integrity of the instruction using the checksum.

[0920] According to one embodiment, the method further includes the steps of: encrypting a data packet in an external system using the secret key of the external system; and decrypting the data packet in an implantable medical device using the secret key of the implantable medical device.

[0921] According to one embodiment, the step of verifying the electronic signature comprises comparing the electronic signature with an electronic signature stored in a medical device capable of implantation.

[0922] According to one embodiment, the step of wirelessly transmitting a data packet to an implantable medical device comprises transmitting the data packet from a first external device to a second external device using wired communication, and wirelessly transmitting the data packet from the second external device to an implantable medical device.

[0923] According to one embodiment, the step of wirelessly transmitting a data packet to an implantable medical device comprises transmitting the data packet from a first external device to a second external device, and then wirelessly transmitting the data packet from the second external device to the implantable medical device. The second external device transmits the data packet without modifying it and / or without performing full decoding.

[0924] According to one embodiment, the step of wirelessly transmitting a data packet to an implantable medical device includes the steps of wirelessly transmitting the data packet from a first external device to a second external device using a first network protocol, and wirelessly transmitting the data packet from the second external device to an implantable medical device using a second network protocol.

[0925] According to one embodiment, the step of wirelessly transmitting a data packet to an implantable medical device includes the steps of wirelessly transmitting the data packet from a first external device to a second external device using a first frequency band, and wirelessly transmitting the data packet from the second external device to an implantable medical device using a second frequency band.

[0926] According to one embodiment, the step of wirelessly transmitting a data packet to an implantable medical device comprises the steps of wirelessly transmitting the data packet from a first external device to a second external device using a first wireless technology, and wirelessly transmitting the data packet from the second external device to an implantable medical device using a second wireless technology, wherein the first wireless technology has an effective range of any of the following: the first wireless technology has an effective range of 2, 4, 8, 20, 50, or 100 times that of the first wireless technology.

[0927] According to one embodiment, the implantable medical device comprises a central unit including a wireless transceiver and a security module connected to the central unit. The step of decrypting a data packet in the implantable medical device comprises transferring the data packet from the central unit to the security module and performing at least a portion of the decryption in the security module.

[0928] According to one embodiment, the security module has a set of rules for accepting communications from a central unit, and the step of forwarding data packets from the implant's receiving unit to the security module comprises verifying compliance with the set of rules.

[0929] According to one embodiment, the wireless transceiver is configured to be placed in an off mode in which it cannot receive radio communications, and the set of rules includes rules that stipulate that communications from the central unit are accepted by the security module only when the wireless transceiver is in the off mode.

[0930] According to one embodiment, the step of electronically signing an instruction in an external system consists of electronically signing the instruction in the external system using the secret key of the external system.

[0931] According to one embodiment, the step of verifying an electronic signature comprises the steps of sending a query from the medical device to an external system based on the public key associated with the external system's private key, and the medical device receiving a response based on ownership of the private key in the external system, and verifying that the response based on ownership of the private key matches the query based on the public key.

[0932] According to one embodiment, the step of forming a data packet is performed in a first external device, and the step of digitally signing an instruction includes digitally signing an instruction using a first secret key, and the method further includes: transmitting a data packet from a first external device to a second external device; in the second external device, verifying that the transmitter is a trusted transmitter; in response to the verification, digitally signing the data packet using a second secret key; transmitting the data packet from the second external device to a medical implant; and in the medical implant, verifying the digital signatures generated using the first and second secret keys. The method may further include verifying the integrity of the instruction using a checksum.

[0933] According to one embodiment, the method according to any one of the embodiments is performed without an internet connection and / or regardless of time.

[0934] According to one embodiment, the method further comprises the central server being accessed by at least one healthcare professional, and the healthcare professional providing input to the central server to form instructions to be sent to an implantable medical device.

[0935] According to one embodiment, the central server is accessed by at least one patient, who can provide input to the central server to verify at least one of the reliability of the healthcare provider and the accuracy of the instructions.

[0936] According to one embodiment, healthcare providers can electronically sign prescriptions on a central server, and / or patients can electronically sign prescriptions on a central server.

[0937] According to one embodiment, the method further includes the steps of verifying the authenticity of the first and second keys in a central server, and digitally signing the instructions using the first and second keys.

[0938] According to one embodiment, the second key is a user key, and the method may include the step of using the second key for at least one of the following: authorizing that a communication be transmitted to an implantable medical device, and authorizing that a healthcare provider prepare instructions for the implantable medical device.

[0939] According to one embodiment, the approval step can be performed by a first or second external device.

[0940] According to one embodiment, a first key is required to create instructions for an implantable medical device, and a second key is re...

Claims

1. 1. A system for affecting an effector response in a patient, comprising: a stimulation device configured to directly or indirectly deliver a first stimulation signal to sympathetic nerves innervating the patient's internal urethral sphincter and a second stimulation signal to parasympathetic nerves innervating the patient's bladder; a control unit configured to control operation of the stimulation device, wherein the first stimulation signal inhibits sympathetic activity and the second stimulation signal stimulates parasympathetic activity; A system comprising:

2. 2. The system of claim 1, wherein the control unit is configured to control operation of the stimulator such that at least one of the first stimulation signal and the second stimulation signal is a periodic signal including at least one of a variable frequency component, a variable duty cycle component, a variable amplitude component, and a variable pause component.

3. 3. The system of claim 1 or claim 2, wherein the first signal is a high frequency signal configured to inhibit sympathetic activity and the second signal is a low frequency signal configured to stimulate parasympathetic activity.

4. 4. The system of claim 3, wherein the amplitude of the low frequency signal varies with frequency in the range of 0.1 to 100 Hz, and the amplitude of the high frequency signal varies with frequency in the range of 1 to 10 kHz.

5. 4. The system of claim 1, wherein at least one of the first and second stimulation signals comprises a series of pulses having a negative voltage relative to ground.

6. 6. The system of claim 5, wherein the control unit is configured to operate the stimulator to generate one or more negative voltage pulses followed by a positive voltage pulse.

7. The system of claim 1 , wherein at least one of the first stimulation signal and the second stimulation signal is an electrical signal or a vibration signal.

8. 8. The system of claim 1, wherein the control unit is configured to operate the stimulation device to alternately apply the first stimulation signal to a sympathetic nerve and the second stimulation signal to a parasympathetic nerve.

9. 8. The system of claim 1, wherein the control unit is configured to operate the stimulation device to simultaneously apply the first stimulation signal to a sympathetic nerve and the second stimulation signal to a parasympathetic nerve.

10. 10. The system of claim 1, wherein the control unit is configured to control operation of the stimulator to generate an effector response as a muscular response.

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