Devices and methods for achieving bladder control - Patents.com

Abstract

The present disclosure relates to techniques for restricting the bladder and 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 continence and bladder emptying, thereby preventing or treating involuntary urinary retention. More particularly, the present invention relates to an implantable device for draining urine from the bladder using a power member actuated from outside the bladder assisted by a support structure. [Background technology]

[0002] Urinary dysfunction is commonly caused by spinal cord injury, with involuntary urinary retention. This condition is associated with urinary tract infection, kidney damage, and urinary tract injury. A common treatment for urinary retention is continuous or intermittent catheterization. Catheters are not only inconvenient for patients, but they also carry the constant risk of infection. Summary of the Invention

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

[0004] According to one aspect, an implantable pump device for draining urine from a patient's bladder (U) is provided. The implantable pump device includes a rotor carrying a constriction device. The constriction device includes a first constriction element, a second constriction element, and a third constriction element. The constriction elements are positioned equidistant from an axis of rotation of the rotor. The implantable pump device further includes a support element spaced 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 includes a controller configured to control the rotor such that the constriction elements sequentially constrict a series of selected portions of the bladder to drain urine from the bladder.

[0005] According to one aspect, an implantable pumping device for draining urine from a patient's bladder is provided. The implantable pumping device includes a first actuatable hydraulic constriction element configured to expand to constrict the bladder to restrict fluid flow therethrough. The implantable pumping device further includes a second actuatable hydraulic constriction element configured to expand to constrict the bladder to restrict fluid flow therethrough and drain urine from the bladder. The implantable pumping device further includes an interconnecting fluid conduit fluidly connecting the first actuatable hydraulic constriction element to the second actuatable 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 urinary tract to restrict fluid flow therethrough, the second operable hydraulic constriction element is configured to be positioned in a second portion of the bladder downstream of the first portion to constrict the second portion of the bladder to restrict fluid flow therethrough and to drain urine from the bladder, and the communicating fluid line is configured to conduct fluid from the first operable hydraulic constriction element to the second operable hydraulic constriction element when pressure in the first operable hydraulic constriction element increases, causing the second operable hydraulic constriction element to further constrict the second portion of the bladder.

[0006] According to one aspect, an implantable pump device for draining urine from a patient's bladder is provided. The implantable pump device includes a first implantable constriction device for constricting the bladder. The first implantable constriction device includes a first manipulable hydraulic constriction element configured to be inflated, thereby expanding in a first direction toward the bladder and constricting a first portion of the bladder to restrict fluid flow therethrough. The first implantable constriction device further includes a support-operable hydraulic constriction element configured to support the first manipulable hydraulic constriction element as the first implantable constriction device is inflated, thereby expanding in the first direction toward the bladder and constricting the first portion of the bladder to restrict fluid flow therethrough. The implantable pump device further includes a second implantable constriction device similar to the first implantable constriction device. The second implantable constriction device is configured to constrict a second portion of the bladder downstream of the first portion to drain urine from the bladder. The second portion extends a greater axial distance than the first portion.

[0007] According to one aspect, an implantable pumping device for draining urine from a patient's bladder is provided. The implantable pumping device includes a first constriction device for constricting the bladder. The first constriction device includes a first actuable hydraulic constriction element configured to expand to exert pressure on the bladder in a first direction to constrict a first portion of the bladder to restrict fluid flow therethrough. The first constriction device further includes a second actuable hydraulic constriction element configured to expand to exert pressure on the bladder in a second direction to constrict the first portion of the bladder to restrict fluid flow therethrough. The first constriction device further includes a first hydraulic system in fluid communication with the first actuable hydraulic constriction element. The first constriction device further includes a second hydraulic system in fluid communication with the second actuable hydraulic constriction element. The first and second actuable hydraulic constriction elements are independently adjustable. The implantable pump device further includes a second constriction device for constricting the bladder and draining urine from the bladder. The second constriction device includes a third operable hydraulic constriction element configured to expand to exert pressure on the bladder in a first direction to restrict fluid flow therethrough and constrict a second portion of the bladder to drain urine from the bladder. The second constriction device further includes a fourth operable hydraulic constriction element configured to expand to exert pressure on the bladder in a second direction to restrict fluid flow therethrough and constrict the second portion of the bladder to drain urine from the bladder. The second constriction device further includes a third hydraulic system in fluid communication with the third operable hydraulic constriction element. The second constriction device further includes a fourth hydraulic system in fluid communication with the fourth operable hydraulic constriction element. The third and fourth operable hydraulic constriction elements are independently adjustable.

[0008] According to one aspect, an implantable pumping device for draining urine from a patient's bladder is provided. The implantable pumping device includes a first constriction device for constricting the bladder. The first constriction device includes an actuatable hydraulic constriction element configured to expand to apply pressure to the bladder. The first constriction device further includes a first hydraulic reservoir for holding hydraulic fluid. The first constriction device further includes a first hydraulic pump for pumping fluid from the first hydraulic reservoir to the first actuatable hydraulic constriction element. The first constriction device further includes a first fluid conduit forming a fluid connection between the first hydraulic reservoir and the first hydraulic pump. The implantable pumping device further includes a second constriction device for constricting the bladder downstream of the first constriction device to drain urine from the bladder. The second constriction device includes a second actuatable hydraulic constriction element configured to expand to apply pressure to the bladder. The second constriction device further includes a second hydraulic reservoir for holding hydraulic fluid. The second constriction device further includes a second hydraulic pump for pumping fluid from the second hydraulic reservoir to the second operable hydraulic constriction element. The second constriction device further includes a second fluid conduit forming a fluid connection between the second hydraulic reservoir and the second hydraulic pump. The implantable pump device further includes an electrode arrangement configured to be positioned between at least one of the first constriction device, the second constriction device, and the bladder. The electrode arrangement is configured to engage and electrically stimulate bladder muscle tissue to exercise the muscle tissue and improve the long-term implantation condition of the implantable pump device.

[0009] According to one aspect, an implantable pumping device for draining urine from a patient's bladder is provided. The implantable pumping device includes a first constriction device for constricting the bladder to restrict fluid flow therethrough. The first constriction device includes a first actuable hydraulic constriction element configured to expand to exert pressure on the bladder. The first constriction device further includes a second actuable hydraulic constriction element configured to expand to exert pressure on the bladder. The first constriction device further includes a first hydraulic pump for pumping fluid through the actuable hydraulic constriction element. The first constriction device further includes a second hydraulic pump for pumping fluid through the actuable hydraulic constriction element. The first constriction device further includes a motor. The motor is mechanically connected to the first and second hydraulic pumps for driving the first and second hydraulic pumps. The implantable pumping device further includes a second constriction device downstream of the first constriction device for constricting the bladder. The second constriction device is configured to drain urine from the bladder. The second constriction device is similar to the first constriction device.

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

[0011] According to one aspect, an implantable pumping device for draining urine from a patient's bladder is provided. The implantable pumping device includes a first constriction device for constricting the bladder to restrict fluid flow therethrough. The implantable constriction device includes a first operable hydraulic constriction element configured to expand to apply pressure to the bladder. The first constriction device further includes a first hydraulic pump for pumping hydraulic fluid to the first operable hydraulic constriction element. The implantable pumping device includes a second constriction device configured to constrict the bladder downstream of the first constriction device to drain urine from the bladder. The second constriction device includes a second operable hydraulic constriction element configured to expand to apply pressure to the bladder. The second constriction device includes a second hydraulic pump for pumping hydraulic fluid to the second operable hydraulic constriction element. The implantable pumping device further includes a controller configured to control the first and second hydraulic pumps. The control device includes 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 includes an external control unit adapted to be placed outside the patient's body. The external control unit includes a first coil adapted to generate a magnetic field detectable by the internal sensor. The control device is further configured to set the processing unit to the active mode in response to the detected magnetic field exceeding a predetermined value.

[0012] According to one aspect, a method of implanting an implantable pump device is provided, the method including the steps of: making an incision in a 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 such that the implantable pump device constricts the bladder to restrict fluid flow therethrough and permit urine to be expelled from the bladder.

[0013] According to one aspect, a method in an implantable control device for controlling an implantable pumping device to constrict a bladder and drain urine from the bladder is provided. The method includes releasing pressure on first and second implantable hydraulic constriction elements so that the bladder is substantially unpressurized. The method further includes measuring pressure within the first and / or second implantable hydraulic constriction elements when the bladder is substantially unpressurized. The method further includes increasing the pressure within the first implantable hydraulic constriction element to a predetermined level. The method further includes increasing the pressure within the second implantable hydraulic constriction element to a second predetermined level.

[0014] According to one aspect, a control device for controlling pressure in an implantable pumping device for constricting a bladder and draining urine from the bladder is provided. The control device includes a pressure sensor for measuring pressure in a first and / or second implantable hydraulic constriction element. The control device further includes a computing unit configured to create an absolute pressure by subtracting the pressure in the first and / or second implantable hydraulic constriction element when the bladder is substantially unpressurized from the pressure in the first and / or second implantable hydraulic constriction element when the pressure in the first and / or second implantable hydraulic constriction element is increased.

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

[0016] According to one aspect, a medical device for draining urine from a patient's bladder is provided, the medical device being configured to be held in place by a tissue portion of the patient. The medical device includes an implantable pump device for draining urine from the patient's bladder. The implantable pump device includes a first constriction device configured to constrict a portion of the bladder to close the 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 from the first portion to drain urine from the bladder when the first portion of the bladder is closed. The medical device further includes an implantable energized medical device configured to be held in place by the tissue portion of the patient. The implantable energized medical device includes a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and a first surface configured to face a first tissue surface on the first side of the tissue portion. The implantable energized medical device further includes a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion. The implantable energized medical device further includes a connecting portion configured to be disposed through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and a fourth cross-sectional area in a fourth plane and a third surface configured to engage 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 one another. The third cross-sectional area is smaller than the first, second, and fourth cross-sectional areas such that the first portion, the second portion, and the connecting portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes. The first portion is detachably coupled to at least one of the connecting portion and the second portion. The second portion is configured to connect axially to an implantable pump device.

[0017] An implantable energized medical device configured to be held in place by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through an aperture in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a second cross-sectional area in a third plane. a connecting portion having a cross-sectional area of ​​3 and including a third surface configured to engage a first tissue surface on a first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, the first plane, the second plane, and the third plane being parallel to one another, the third cross-sectional area being smaller than the second cross-sectional area, such that the first portion, the second portion, and the connecting portion are prevented from moving through an opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane, the first portion configured to receive electromagnetic waves at a frequency above a frequency level and / or transmit electromagnetic waves at a frequency below a frequency level, and the second portion configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level, the frequency level being 100 kHz.

[0018] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0019] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency above the frequency level to an external device.

[0020] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0021] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0022] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter at a higher frequency level and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion at a lower frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter at the lower frequency level.

[0023] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0024] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0025] In some embodiments, the first control device is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device above the frequency level, and the first control device is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion below the frequency level.

[0026] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion at or below the frequency level.

[0027] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0028] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0029] In some embodiments, the second portion comprises an outer casing made of titanium.

[0030] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0031] An implantable energized medical device configured to be held in place by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and tissue extending between the first and second sides of the tissue portion. a connecting portion configured to be positioned through the hole in the tissue portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface on a first side of the 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 one another, the third cross-sectional area being smaller than the second cross-sectional area, and 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 configured to receive and / or transmit electromagnetic waves at a frequency less than a frequency level, the frequency level being 100 kHz.

[0032] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0033] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency equal to or less than the frequency level to the second portion.

[0034] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to an external device.

[0035] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0036] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0037] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter below a frequency level, and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion below a frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter below a frequency level.

[0038] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0039] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0040] In some embodiments, the first control device is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device at a frequency level below, and the first control device is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion at a frequency level below.

[0041] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion at or below the frequency level.

[0042] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0043] In some embodiments, the first portion comprises an outer casing made of titanium.

[0044] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0045] In some embodiments, the second portion comprises an outer casing made of titanium.

[0046] In some embodiments, the outer casing forms a complete enclosure, and electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0047] An implantable energized medical device configured to be held in place by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion, through an opening in the tissue portion extending between the first and second sides of the tissue portion. a connecting portion configured to be positioned on a first side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface on a first side of the 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 one another, the third cross-sectional area being smaller than the second cross-sectional area, and configured to prevent 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 plane, the second plane, and the third plane, the first portion being made from a polymeric material and the second portion being composed of a casing made from titanium, the casing forming a complete housing.

[0048] In some embodiments, the casing of the second part forms a complete enclosure when the second part is connected to the connecting part, such that the entire outer surface of the second part is covered by the casing.

[0049] In some embodiments, the first portion comprises a casing made from a polymeric material.

[0050] 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.

[0051] In some embodiments, the connecting portion comprises a connector that connects to the first portion and the second portion, respectively, and is arranged to transmit electrical signals and / or energy.

[0052] In some embodiments, the joint is disposed in the joint core such that it is sealed by the outer material of the joint.

[0053] In some embodiments, the coupling portion comprises a ceramic material.

[0054] In some embodiments, the connections are encapsulated in a ceramic material.

[0055] In some embodiments, the first portion comprises a first connecting portion configured to connect to a connecting portion of the connecting portion.

[0056] In some embodiments, the second portion comprises a second connecting portion configured to connect to the connecting portion of the connecting portion.

[0057] In some embodiments, the casing of the second portion is hermetically sealed.

[0058] In some embodiments, the second connection is positioned such that the hermetic seal of the second portion remains intact.

[0059] In some embodiments, the casing of the first portion is sealed.

[0060] An implantable energized medical device configured to be held in place by a tissue portion of a patient is provided, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to engage the first tissue surface on the first side of the tissue portion. a connecting portion having a third surface, 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 one another, 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 a hole in 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 length direction diverging from the central extension axis; the connecting portion having a substantially constant cross-sectional area along the central extension axis or a cross-sectional area that decreases in a direction from the first portion to the second portion along the central extension axis, and / or the second portion having a substantially constant cross-sectional area along the length direction or a cross-sectional area that decreases in the length direction.

[0061] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0062] In some embodiments, the connecting portion tapers along the central extension axis in a direction from the first portion to the second portion.

[0063] In some embodiments, the connecting portion has a circular or elliptical cross-section along the central elongate axis that decreases in diameter in a direction from the first portion to the second portion.

[0064] In some embodiments, the second portion is tapered in its length.

[0065] In some embodiments, the connecting portion has a circular or elliptical cross section that decreases in diameter along its length.

[0066] In some embodiments, the length direction extends from the interface between the connecting portion and the second portion toward an end of the second portion.

[0067] In some embodiments, the length direction extends substantially perpendicular to the central elongation axis.

[0068] According to one aspect, a method of implanting an energized medical device is provided. The method includes positioning a second portion of the implantable energized medical device between the peritoneum and a layer of abdominal wall musculature. The method further includes positioning a first portion of the implantable energized medical device between the patient's skin and a layer of abdominal wall musculature. The first and second portions are configured to be connected by a connecting portion extending through at least one layer of abdominal wall musculature. The method further includes positioning a body-engaging portion of the energized medical device in connection with a tissue or organ of the patient affected by the energized medical device. The method further includes positioning a transmission member at least partially between the peritoneum and the layer of abdominal wall musculature, the transmission member configured to transmit at least one of energy and force from the second portion to the body-engaging portion, such that at least one-third of the length of the transmission member is disposed outside the peritoneum.

[0069] According to one aspect, an external device configured to communicate with an implantable medical device when implanted in a patient is provided, the external device comprising at least one first wireless transceiver configured to communicate with the implantable medical device using a first network protocol to determine a distance between the 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 external device and the implantable medical device.

[0070] According to one aspect, an implantable medical device configured to communicate with an external device is provided, the implantable medical device comprising at least one first wireless transceiver configured to communicate with the external device using a first network protocol to determine a distance between the external device and the implantable medical device, and at least one second wireless 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.

[0071] According to one aspect, a patient-external device is provided that is configured to communicate with an implantable medical device when implanted in a patient. The patient-external device includes a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and configured to wirelessly communicate with a patient display device, and a computing unit configured to execute control software to generate control commands for operation of the implantable medical device. The computing unit is configured to transmit a control interface as a remote display portal to the patient display device configured to display the control interface to a user, receive user input from the patient display device, and convert the user input into control commands for wireless transmission to the implantable medical device.

[0072] According to one aspect, there is provided a patient display device for communicating with a patient remote external device for communicating with an implantable medical device, the patient display device comprising: a wireless communication unit configured to wirelessly receive an implant control interface as a remote display portal from the patient remote external device and configured to wirelessly transmit implant control user input to the patient remote external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from a user.

[0073] According to one aspect, a communication system is provided that enables communication between a patient display device and an implantable medical device when implanted. The communication system includes a patient display device, a server, and a patient remote external device. The patient display device includes a wireless communication unit configured to wirelessly receive an implant control interface as a remote viewing portal provided by the patient remote external device. The wireless communication unit is further configured to wirelessly transmit implant control user inputs intended for the patient remote external device to the server. The system further includes a display for displaying the received remote viewing portal and an input device for receiving implant control inputs from a user. The patient remote external device includes 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 execute control software for generating control commands for operation of the implantable medical device, transmit the control interface to the patient display device, receive implant control user inputs generated at the patient display device from the server, and convert the user inputs into control commands for wireless transmission to the implantable medical device.

[0074] According to one embodiment, a patient display device is provided for communicating with a patient-external device when an implantable medical device is implanted. The patient display device includes 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 execute a first application for wireless communication with a server and / or a DDI and a second application for wireless communication with the patient-external device for transmitting the implant control inputs to a remote display portal of the patient-external device for communication with the implantable medical device, the second application being configured to be accessed via the first application. The patient display device includes a first login function and a second login function, the first login function allowing a 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 can be configured to use at least one of a password, a pin code, a fingerprint, voice, and face authentication. The second login function in the first application is configured to authenticate a second hardware key of the patient-external device for a defined period of time using a secret key from the user.

[0075] According to one aspect, a communication system is provided that enables communication between a patient display device and an implantable medical device when implanted. The communication system includes a patient display device, a server or DDI, and a patient remote external device. The patient display device includes a wireless communication unit configured to wirelessly receive an implant control interface from the patient remote external device as a remote display portal, and the wireless communication unit is further configured to wirelessly transmit implant control user input to the patient remote external device and includes a display for displaying the received implant control interface as the remote display portal and an input device for receiving implant control input from a user. The patient display device is configured to execute a first application for wireless communication with the server and a second application for wireless communication with the patient remote external device for transmitting the implant control input to the remote display portal of the patient remote external device for communication with the implantable medical device. The patient remote external device includes a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device based on the implant control input and configured to wirelessly communicate with the patient display device.

[0076] According to one aspect, a computer program product is provided that is configured to run on a patient display device that includes 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 includes: a first application for communication with a server or DDI; a second application for communication with a patient remote external device for transmitting the implant control input via the remote display portal of the patient remote external device for communication with an implantable medical device, the second application being configured to be accessed via the first application; a first login function that uses at least one of a password, a pin code, a fingerprint, or face authentication; and a second login function within the first application that uses 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.

[0077] According to one aspect, a communication system is provided that enables communication among a patient display device, a patient external device, a server, and an implantable medical device. The communication system includes a server, a patient display device, a patient external device, and an implantable medical device. The patient display device includes 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 includes a wireless communication unit configured to wirelessly transmit control commands to the implantable medical device and configured to wirelessly communicate with at least one of the patient display device and the server. The server further includes 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 includes a wireless communication unit configured to wirelessly communicate with the patient external device. The implantable medical device further includes an encryption unit configured to encrypt data destined for the server and transmit the data to the server via the patient external device, with the patient external device acting as a router that forwards the data without full decryption. In one embodiment, the implantable medical device comprises an encryption unit and is configured to encrypt data destined for the patient display and transmit the data to the patient display via the patient external device, with the patient external device acting as a router forwarding the data without full decryption. In one embodiment, the server comprises an encryption unit and is configured as follows: to encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the patient external device, with the patient external device acting as a router forwarding the data without full decryption; to encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the patient display and the patient external device, with the patient display and the patient external device acting as a router forwarding the data without full decryption. In one embodiment, the patient display comprises an encryption unit and is configured as follows: to encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the patient external device, with the patient external device acting as a router forwarding the data without full decryption.In one embodiment, the patient display device includes an encryption unit and is configured to encrypt data destined for the implantable medical device and transmit the data to the implantable medical device via the server and the patient external device, with the server and the patient external device acting as a router to forward the data without full decryption.

[0078] According to an aspect, there is provided a server for use in a communication system according to any one of the above aspects or the following embodiments.

[0079] According to an aspect, there is provided a patient display device for use in a communication system according to any one of the above aspects or the following embodiments.

[0080] According to an aspect, there is provided a patient external device for use in a communication system according to any one of the above aspects or the following embodiments.

[0081] According to an aspect, there is provided an implantable medical device for use in a communication system according to any one of the above aspects or the following embodiments.

[0082] According to one aspect, a system configured to remotely change preprogrammed therapy settings of an implantable medical device implanted in a patient is provided. The system includes at least one healthcare provider (HCP), an EID external device, and an HCP private key device. The HCP EID external device is adapted to receive commands from the HCP to change the preprogrammed therapy 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 private key device. The HCP private key device is adapted to be provided to the HCP EID external device via at least one of a read slot for the HCP private key device or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical contact. The HCP EID external device further includes at least one wireless transceiver configured to communicate with a data infrastructure server (DDI) via a first network protocol.The system further includes a data infrastructure server DDI adapted to receive commands from the HCP EID external device and relay the received commands to a patient EID external device without modifying the commands, the DDI comprising a wireless transceiver configured to communicate with the patient external device and a patient EID external device adapted to receive the commands relayed by the DDI, the implanted medical device further adapted to transmit the commands to the implanted medical device, and further adapted to receive commands from the HCP EID external device via the DDI to change the pre-programmed therapy settings of the implanted medical device, the implanted medical device further adapted to be activated, authenticated, and authorized to execute the commands by the patient providing at least one of a patient private key device adapted to be provided by the patient to the patient EID external device by: a patient private key device read slot or equivalent, RFID communication or other near-field wireless activation communication, or direct electrical contact. The patient EID external device is configured with at least one of an HCP private key device read slot or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical contact. The patient EID external device further comprises at least one wireless transceiver configured to communicate with the implantable medical device via a second network protocol, and the implanted medical device is further configured to treat the patient or perform a bodily function.

[0083] According to one aspect, a system is provided that is configured to change preprogrammed therapy settings of an implantable medical device by a healthcare provider (HCP) in the patient's physical presence when the device is implanted. The system includes at least one HCP EID external device adapted to receive commands, directly or indirectly, from the HCP to change the preprogrammed therapy settings of the implantable medical device when the device is implanted. The HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device that includes an HCP private key. The HCP private key device may be at least one of a smart card, a keychain device, a watch, a wristband, a necklace, and any shape of device. The HCP EID external device is adapted to participate in at least one of receiving information from the implant, receiving information from a patient remote external device, activating the implanted medical device, changing the preprogrammed settings, and updating the software of the implanted medical device. The HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the commands by the patient. The system further includes a patient private key device including a patient private key, the patient private key device including at least one of a smart card, a key fob device, a watch, a wrist or arm band, a necklace, and a device of any shape. The HCP private key and the patient private key are necessary for the HCP EID external device to perform at least one of the following operations when the implantable medical device is implanted: receive information from the implantable medical device, receive information from a patient remote external device, operate the implantable medical device, change preprogrammed settings, and update software on the implantable medical device.

[0084] According to one aspect, a system is provided for modifying a preprogrammed and preselected therapeutic operation of an implantable medical device upon patient command when implanted in the patient. The system includes the 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 expose a button for the patient to indicate an intent to activate a function of the implantable medical device through the patient remote external device, and further configured to remotely present on the patient display a display portal that enables the patient to activate a function of the implantable medical device through the display portal of the patient remote external device visualized on the patient display.

[0085] According to one aspect, a system configured to provide information from an implantable medical device implanted in a patient from a remote location is provided. The system includes at least one patient EID external device adapted to receive information from the implant and further adapted to transmit such information to a server or dedicated data infrastructure (DDI), and further adapted to be activated and authenticated by the implantable medical device and authorized to receive the information by the patient providing a private key. The system further includes a patient private key device including a private key adapted to be provided to the patient EID external device via at least one of a patient private key device read slot or equivalent, RFID communication or other near-field wireless activation communication, or direct electrical connection. The patient EID external device is configured with at least one of a patient private key device read slot or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical connection. The patient EID external device further includes at least one wireless transceiver configured to communicate with the DDI via a first network protocol.

[0086] According to one aspect, a system is provided, comprising: an implantable medical device adapted, upon implantation in a patient, to communicate with an external device, 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, upon implantation, to communicate with the implantable medical device, send commands to the implantable medical device, and change preprogrammed settings therein; and a patient private key device including a patient private key adapted to activate, authenticate, and execute the commands by the patient EID external device, the private key being adapted to be provided to the external device via at least one of an HCP private key device read slot or equivalent, RFID communication or other near-field wireless activation communication, or direct electrical contact. The system further comprises a data infrastructure server (DDI) adapted to send a command to the patient EID external device to disable the authorization and authentication functions of the patient private key for further transmission to the implantable medical device.

[0087] According to one aspect, a system is provided that allows a healthcare provider (HCP) to change preprogrammed therapy settings in an implantable medical device step when implanted in a patient, either in the patient's physical presence or remotely from the patient. The system includes at least one HCP EID external device adapted to receive commands directly or indirectly from the HCP to change the preprogrammed therapy settings in the implantable medical device step when implanted. The HCP EID external device is further adapted to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device that includes an HCP private key. The HCP private key comprises at least one of a smart card, a key fob device, a watch, a wrist or wrist band, a necklace, and a device of any shape. The system further includes a patient private key device that includes the patient private key, the patient private key device being comprised of at least one of a smart card, a key fob device, a watch, a wrist or arm band, a necklace, and a device of any shape. Both the HCP Private Key and the Patient Private Key are required to perform the actions by the HCP EID external device to change settings pre-programmed into the implantable medical device when the implantable medical device is implanted and to update the software of the implantable medical device. The Patient Private Key is adapted to activate, authenticate, and authorize the execution of the commands provided by the HCP via the HCP EID external device or when actions are performed remotely via the Patient EID external device.

[0088] According to one aspect, a system is provided that is configured to allow a healthcare provider (HCP) to remotely change preprogrammed therapy settings in an implantable medical device upon implantation in a patient. The system includes at least one HCP EID external device adapted to receive commands, directly or indirectly, from the HCP to change the preprogrammed therapy settings in the implantable medical device upon implantation, the HCP EID external device being further adapted to be activated, authenticated, and authorized to execute the commands by the HCP. Operations by the HCP EID external device to change the preprogrammed settings and update software on the implantable medical device upon implantation are adapted to be authenticated by an HCP private key device and a patient private key device.

[0089] According to one aspect, a system configured to change preprogrammed therapy settings of an implantable medical device implanted in a patient from a remote location is provided. The system includes at least one healthcare provider (HCP) external device adapted to receive commands from an HCP to change the preprogrammed therapy 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 private key device adapted to be provided to the HCP EID external device via at least one of an HCP private key device read slot or equivalent, RFID communication, other near-field wireless activation communication, or direct electrical contact. The HCP EID external device further includes at least one wireless transceiver configured to communicate with the patient EID external device via a first network protocol. The system includes a patient EID external device adapted to receive commands from the HCP-external device and relay the received commands to the implantable medical device without modifying the commands, the patient EID external device having a wireless transceiver configured to communicate with the patient-external device, the patient EID external device adapted to send commands to the implantable medical device and to receive commands from an HCP to change the pre-programmed therapy settings of the implantable medical device, and further adapted to be activated and authenticated by a patient providing a patient private key device having a patient private key and authorized to execute the commands.

[0090] According to one embodiment, the control device is configured to control the first and second constriction devices such that the first constriction device closes a first portion of the bladder, and the second constriction device constricts a second portion of the bladder when the first portion of the bladder is closed to expel urine from the bladder.

[0091] According to one embodiment, the controller is configured to receive a pressure signal from a pressure sensor configured to measure a pressure on at least one of the first and second constriction devices.

[0092] According to an embodiment, at least one of the first and second constriction devices is a hydraulic constriction device.

[0093] According to embodiments, at least one of the first and second constriction devices is a constriction device configured to electrically stimulate and constrict at least one tissue wall of the bladder.

[0094] According to embodiments, the second constriction device is configured to constrict a second portion of the bladder using electrical stimulation, and the implantable pump device further comprises a cancellation unit configured to be positioned downstream of the second portion, the cancellation unit configured to cancel the electrical stimulation such that the urethral sphincter muscles are substantially unaffected by the electrical stimulation.

[0095] According to one embodiment, a first constriction device is configured to constrict a first portion of the bladder extending axially in the direction of urine flow a first distance, and a second constriction device is configured to constrict a second portion of the bladder extending axially in the direction of urine flow a second distance, the second distance being at least twice as long as the first distance.

[0096] According to embodiments, at least one of the first and second constriction devices comprises at least one constriction 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 retaining a force from the at least one constriction element such that the bladder is constricted between the at least one constriction element and the abutment.

[0097] According to embodiments, at least one of the first and second constriction devices comprises at least first and second constriction elements, the first constriction element configured to contact a first portion of the bladder and the second constriction element configured to contact a second portion of the bladder, such that the bladder is constricted between the first and second constriction elements.

[0098] According to one embodiment, the implantable pump device further comprises a support element, and at least one of the at least one constriction element and the at least one abutment is connected to the support element.

[0099] According to an embodiment, the support element is configured to form at least a part of a surrounding structure configured to surround the bladder.

[0100] According to one embodiment, the support element comprises at least one fluid conduit at least partially integrated in the support element.

[0101] According to one embodiment, the support element comprises a connection portion for connecting the support element to another support element to at least partially form a surrounding structure.

[0102] According to one embodiment, the support element forms part of a hinge for hingedly connecting the support element to other support elements to at least partially form a surrounding structure.

[0103] According to an embodiment, at least one of the support element, the at least one abutment and the at least one constriction element comprises at least one curvature that matches the curvature of the bladder.

[0104] According to one embodiment, the implantable pump device further comprises an electrode arrangement configured to engage and electrically stimulate bladder musculature to exercise the musculature to improve the condition of long-term implantation of the implantable pump device.

[0105] According to one embodiment, the abutment comprises at least one cushioning element configured to contact the bladder, the cushioning element being more resilient than the support element.

[0106] According to an embodiment, the first constriction device comprises a first curved portion having a first radius that conforms to the curvature of the bladder, and the second constriction device comprises a second curved portion having a second radius that conforms to the curvature of the bladder, the first radius being smaller than the second radius.

[0107] According to an embodiment, the first contraction device can have an opening in its uncontracted state that is larger than the opening of the second contraction device in its uncontracted state, such that the first contraction device can initially surround a portion of the bladder that has a larger cross-section than a second portion that the second contraction device can surround.

[0108] In one embodiment, the opening of the first constriction device has an internal diameter of about 5-12 cm, preferably about 8-11 cm, in the unconstricted state to accommodate a correspondingly sized bladder. Diameter in this context refers to the cross-sectional opening, which does not necessarily have to be a perfectly circular opening, but rather an opening that fits the bladder.

[0109] In one embodiment, the opening of the second deflation device has an inner diameter of about 1-8 cm, preferably about 2-5 cm, in an undeflated state to accommodate a correspondingly sized bladder.

[0110] According to one embodiment, the second constriction device comprises a plurality of constriction elements configured to sequentially constrict the bladder to expel urine from the bladder.

[0111] According to one embodiment, the mechanical structure device comprises at least one mechanical constriction element comprising an electric motor, a screw, and a plate, wherein the electric motor is configured to rotate the screw to push the plate toward the bladder to constrict the bladder.

[0112] According to one embodiment, the implantable pump device further comprises an electrical stimulation device including electrodes disposed on the stenotic element and configured to electrically stimulate the stenotic segment with electrical pulses.

[0113] According to one embodiment, the electrodes are configured to stimulate the tissue of the bladder to avoid tissue damage due to the pressure of the constriction element.

[0114] According to one embodiment, the electrodes are configured to stimulate bladder tissue to thicken the tissue at the stricture to close the passageway of the bladder.

[0115] According to one embodiment, the implantable pump device further comprises a cancellation unit configured to be positioned downstream of the rotor and the constriction element, the cancellation unit configured to cancel the electrical stimulation such that the urethral sphincter is not substantially affected by the electrical stimulation.

[0116] According to one embodiment, the lumen of the first operable hydraulic constriction element has a larger volume than the lumen of the second operable hydraulic constriction element.

[0117] According to one embodiment, the lumen of the first operable hydraulic constriction element has a volume that is at least 1.5 times greater than the volume of the lumen of the second operable hydraulic constriction element.

[0118] According to one embodiment, the first interconnecting fluid line includes a first electrically operable valve to control fluid flow between the first operable hydraulic constriction element and the second operable hydraulic constriction element.

[0119] According to one embodiment, the electrically operable valve is a solenoid valve.

[0120] According to one embodiment, the first interconnecting fluid line includes a check valve that allows fluid to flow in a direction from the first operable hydraulic constriction element to the second operable hydraulic constriction element, but does not allow fluid to flow in a direction from the second operable hydraulic constriction element to the first operable hydraulic constriction element.

[0121] According to one embodiment, the implantable pump device further comprises a second interconnecting fluid line fluidly connecting the first operable hydraulic constriction element and the second operable hydraulic constriction element, wherein the cross-sectional area of ​​the lumen of the second interconnecting fluid line is less than 0.5 times the cross-sectional area of ​​the lumen of the first interconnecting fluid line.

[0122] According to one embodiment, the implantable pump device further comprises a hydraulic pump, a reservoir for holding hydraulic fluid, and a first reservoir conduit fluidly connecting the reservoir to a first operable hydraulic constriction element, the hydraulic pump configured to pump fluid from the reservoir through the first reservoir conduit to the first operable hydraulic constriction element to constrict a first portion of the bladder to restrict fluid flow therethrough.

[0123] According to one embodiment, the first reservoir line includes a second electrically operable valve to allow control of fluid flow between the reservoir and the first operable hydraulic constriction element.

[0124] According to one embodiment, the implantable pump device further comprises a second reservoir conduit fluidly connecting the reservoir to a second operable hydraulic constriction element.

[0125] According to one embodiment, the second reservoir line includes a check valve that allows fluid to flow from the reservoir to the second operable hydraulic constriction element, but prevents fluid from flowing from the second operable hydraulic constriction element to the reservoir.

[0126] According to one embodiment, the implantable pump device further comprises an injection port in fluid communication with the reservoir for injecting fluid into the reservoir when the reservoir is implanted.

[0127] According to one embodiment, the injection port is configured to be placed subcutaneously, and the implantable pump device further comprises an injection port conduit fluidly connecting the injection port to the reservoir.

[0128] According to one embodiment, the implantable pump device further comprises at least one of a first pressure sensor configured to sense pressure within the first operable hydraulic constriction element and a second pressure sensor configured to sense pressure within the second operable hydraulic constriction element.

[0129] According to one embodiment, the implantable pump device further comprises a controller configured to receive a pressure sensor signal from at least one of the first and second pressure sensors and to control at least one of the first electrically operable valve, the second operable valve, and the hydraulic pump based on the received pressure sensor signal.

[0130] According to one embodiment, the controller comprises a pressure threshold, and the controller is configured to open the first electrically operable valve when the received pressure sensor signal from the second pressure sensor exceeds the pressure threshold.

[0131] According to one embodiment, the implantable pump device further comprises a supportable hydraulic constriction element 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 hydraulic constriction element configured to assist in constriction of the first and second portions of the bladder.

[0132] According to one embodiment, the supporting operable hydraulic constriction element is connected to the first and second operable hydraulic constriction elements.

[0133] According to one embodiment, the supportive operable hydraulic constriction element is less elastic than at least one of the first and second operable hydraulic constriction elements.

[0134] According to one embodiment, each of the first, second and supportably operable hydraulic constriction elements comprises a lumen surrounded by a resilient wall, the resilient wall of the supportably operable hydraulic constriction element being thicker than the wall of at least one of the first and second operable hydraulic constriction elements.

[0135] According to one embodiment, the implantable pump device further comprises a second hydraulic pump, a second reservoir for holding hydraulic fluid, and a support reservoir conduit fluidly connecting the second reservoir to the supportable hydraulic constriction element, the second hydraulic pump configured to pump fluid from the second reservoir through the support reservoir conduit to the supportable hydraulic constriction element to assist in constriction of the luminal organ.

[0136] According to one embodiment, the implantable pump device further comprises a third pressure sensor configured to sense pressure within the supportable and steerable hydraulic constriction element.

[0137] According to one embodiment, the implantable pump device further comprises a second infusion port in fluid communication with the second reservoir for infusing fluid into the second reservoir when the second reservoir is implanted.

[0138] According to embodiments, the second injection port is configured to be placed subcutaneously. The implantable pump device further comprises a second injection port conduit fluidly connecting the second injection port to the second reservoir.

[0139] According to one embodiment, the supportable maneuverable hydraulic constriction element has a length in an axial direction of the bladder when implanted, and the first and second maneuverable hydraulic constriction elements have a combined length in an axial direction AD of the bladder, the combined length being longer than the length of the supportable maneuverable hydraulic constriction elements.

[0140] According to one embodiment, the implantable pump device further comprises a surrounding structure having a periphery that surrounds the bladder when implanted.

[0141] According to one embodiment, the surrounding structure is substantially rigid.

[0142] According to one embodiment, the main part of the surrounding structure is made from 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.

[0143] According to one embodiment, the surrounding structure has a modulus of elasticity in the radial direction in the range of 0.2 GPa to 1000 GPa, or in the range of 1 GPa to 400 GPa.

[0144] According to one embodiment, the surrounding structure has an inner surface configured to face the bladder when implanted, and a supportable hydraulic constriction device is fixed to the inner surface of the surrounding structure, such that the supportable hydraulic constriction device can be used as a support for constricting the bladder.

[0145] According to one embodiment, the implantable pump device further comprises at least one cushioning element configured to contact the bladder, the cushioning element being secured to an inner surface of the surrounding structure and being more resilient than the surrounding structure.

[0146] According to one embodiment, the surrounding structure is constituted by at least first and second support elements configured to be connected to each other to form at least a part of the periphery of the surrounding structure.

[0147] According to one embodiment, the supportable and operable hydraulic constriction device is fixed to a first support element and the at least one cushion element is fixed to a second support element.

[0148] According to an embodiment, at least one of the first and second support elements has a curvature that matches the curvature of the bladder.

[0149] According to one embodiment, the curvature has a radius in the range of 15 mm to 60 mm.

[0150] According to one embodiment, the curvature has a radius in the range of 20 mm to 50 mm.

[0151] According to one embodiment, the supporting operable hydraulic constriction element is connected to the first operable hydraulic constriction element.

[0152] According to one embodiment, the supporting actuatable hydraulic constriction element is less elastic than the first actuatable hydraulic constriction element.

[0153] According to one embodiment, the first operable hydraulic constriction element comprises an inner lumen surrounded by a resilient wall, and the supportable hydraulic constriction element comprises an inner lumen surrounded by a resilient wall, and a portion of the resilient wall of the supportable hydraulic constriction element is thicker than a portion of the resilient wall of the first operable hydraulic constriction element.

[0154] According to one embodiment, the portion of the resilient wall of the supporting operable hydraulic constriction element is at least 1.5 times thicker than the portion of the resilient wall of the first operable hydraulic constriction element.

[0155] According to one embodiment, the portion of the resilient wall of the supporting operable hydraulic constriction element is more than twice as thick as the portion of the resilient wall of the first operable hydraulic constriction element.

[0156] According to one embodiment, a first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall. The supportable hydraulic constriction element comprises a lumen surrounded by a resilient wall. A portion of the resilient wall of the first operable hydraulic constriction element comprises a first material. A portion of the resilient wall of the supportable hydraulic constriction element comprises a second material. The second material has a higher modulus of elasticity than the first material.

[0157] According to one embodiment, the modulus of elasticity of the second material is at least 1.5 times the modulus of elasticity of the first material.

[0158] According to an embodiment, the modulus of elasticity of the second material is at least twice the modulus of elasticity of the first material.

[0159] According to one embodiment, the implantable pump device further comprises a first hydraulic pump. The implantable pump device further comprises a second hydraulic pump. The implantable pump device further comprises a first reservoir for holding hydraulic fluid. The implantable pump device further comprises a second reservoir for holding hydraulic fluid. The implantable pump device further comprises a first reservoir conduit fluidly connecting the first reservoir to the first operable hydraulic constriction element. The implantable pump device further comprises a support reservoir conduit fluidly connecting the second reservoir to the support operable 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 to constrict the bladder. The second hydraulic pump is configured to pump fluid from the second reservoir through the support reservoir conduit to the support operable hydraulic constriction element to assist in constricting the bladder.

[0160] According to one embodiment, the implantable pump device further comprises a second pressure sensor configured to sense pressure within the supportable and steerable hydraulic constriction element.

[0161] According to one embodiment, the implantable pump device further comprises an implantable controller configured to control at least one of the first hydraulic pumps based on input from the first pressure sensor and the second hydraulic pump based on input from the second pressure sensor.

[0162] According to one embodiment, at least one of the first reservoir conduits includes an electrically operable valve and the second reservoir conduit includes an electrically operable valve, and the controller is configured to control at least one of the electrically operable valves of the first reservoir conduit based on input from the first pressure sensor and to control the electrically operable valve of the second reservoir conduit based on input from the second pressure sensor.

[0163] According to one embodiment, the first reservoir conduit includes a check valve and the second reservoir conduit includes a check valve.

[0164] According to one embodiment, the implantable 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 implanted.

[0165] According to one embodiment, the implantable pump device further comprises a second infusion port in fluid communication with the second reservoir for infusing fluid into the second reservoir when the second reservoir is implanted.

[0166] According to one embodiment, either the first injection port is configured to be placed subcutaneously and the implantable constriction device further comprises a first injection port conduit fluidly connecting the first injection port to the first reservoir, or the second injection port is configured to be placed subcutaneously and the implantable constriction device further comprises a second injection port conduit fluidly connecting the second injection port to the second reservoir.

[0167] According to one embodiment, the supportable maneuverable hydraulic constriction element has an axial length of the bladder when implanted, and the first maneuverable hydraulic constriction element has an axial length of the bladder, and the length of the first maneuverable hydraulic constriction element is longer than the length of the supportable maneuverable hydraulic constriction element.

[0168] According to one embodiment, the supportable and operable hydraulic constriction device is fixed to a first support element and the at least one cushion element is fixed to a second support element.

[0169] According to an embodiment, at least one of the first and second support elements has a curvature that matches the curvature of the bladder.

[0170] According to an embodiment, the second distance is substantially opposite to the first direction.

[0171] According to one embodiment, the first hydraulic system comprises a first hydraulic pump, the second hydraulic system comprises a second hydraulic pump, the third hydraulic system comprises a third hydraulic pump, and the fourth hydraulic system comprises a fourth hydraulic pump.

[0172] According to an embodiment, in the above aspect, each of the first, second, third and fourth hydraulic systems comprises a reservoir for holding hydraulic fluid.

[0173] According to one embodiment, the first, second, third and fourth hydraulic systems are connected to a reservoir for holding hydraulic fluid.

[0174] According to one embodiment, each of the first, second, third and fourth hydraulic circuits includes an injection port for injecting hydraulic fluid into the respective first and second hydraulic circuit.

[0175] According to one embodiment, the injection port is configured to be placed subcutaneously, and the implantable pump device further comprises injection port conduits fluidly connecting the injection port (108) to the first, second, third and fourth hydraulic systems.

[0176] According to one embodiment, the first operable hydraulic constriction element lacks a fluid connection to the second operable hydraulic constriction element, and the third operable hydraulic constriction element lacks a fluid connection to the fourth operable hydraulic constriction element.

[0177] According to an embodiment, the implantable pump device includes 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.

[0178] According to one embodiment, an implantable pump device includes a controller configured to receive pressure sensor signals from at least one of a first, second, third, and fourth pressure sensors, and the control unit is configured to control at least one of the first hydraulic pump, the second hydraulic pump, the third hydraulic pump, and the fourth hydraulic pump based on the received pressure sensor signals.

[0179] According to one embodiment, the surrounding structure comprises an inner surface configured to face the bladder when implanted, and the first, second, third and fourth operable hydraulic constriction elements are secured to the inner surface of the surrounding structure.

[0180] According to one embodiment, the surrounding structure is constituted by at least first and second support elements configured to be connected to each other to form at least a part of the periphery of the surrounding structure.

[0181] According to one embodiment, the first and third operable hydraulic constriction elements are fixed to the first support element, and the second and fourth operable hydraulic constriction elements are fixed to the second support element.

[0182] According to one embodiment, the electrode arrangement is disposed on an outer surface of at least one of the first operable hydraulic constriction element and the second operable hydraulic constriction element.

[0183] According to one embodiment, the electrode arrangement comprises a plurality of electrode elements, each configured to engage and electrically stimulate tissue of the bladder.

[0184] According to one embodiment, the electrode arrangement comprises a coiled wire to increase the contact surface between the electrode arrangement and the tissue of the bladder and enable the electrode arrangement to follow the constriction and relaxation of the tissue of the bladder.

[0185] According to one embodiment, the electrode arrangement comprises exposed electrode portions configured to form a metal-tissue interface with the bladder tissue, such that faradaic charge transfer dominates as the charge transfer mechanism across the interface.

[0186] 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 faradaic portion of the charge transfer mechanism on said interface.

[0187] According to an embodiment, the electrode arrangement comprises at least two electrode elements configured to be placed on opposite sides of the bladder.

[0188] According to one embodiment, the implantable pump device further comprises a stimulation control device configured to be operably connected to the electrode arrangement for controlling electrical stimulation of tissue of the bladder.

[0189] According to an embodiment, the stimulation control device is configured to control the electrical stimulation such that tissue of the bladder is stimulated with a series of electrical pulses.

[0190] According to one embodiment, the stimulation control device is configured to control the electrical stimulation to include a pulse of a first polarity followed by a pulse of a second, opposite polarity.

[0191] 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.

[0192] According to one embodiment, the electrical stimulation signal has a pulse duration of 0.01 to 100 ms.

[0193] According to one embodiment, the electrical stimulation signal has a pulse amplitude of 1-15 mA.

[0194] According to one embodiment, the electrical stimulation signal has a pulse frequency of 0.15-0.25 Hz, a pulse duration of 20-30 ms, and a pulse amplitude of 3-10 mA.

[0195] According to one embodiment, the electrical stimulation signal has a build-up period of 0.01-2 seconds with gradually increasing amplitude, a stimulation period of 1-60 seconds, and a 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.

[0196] According to one embodiment, the stimulation control device is configured to receive input from a wireless remote control device.

[0197] According to one embodiment, the implantable pump device further comprises an implantable sensor configured to sense action potentials generated by pacemaker cells in the tissue of the bladder, and the stimulation control device is configured to control the electrical simulation based at least in part on the sensed action potentials.

[0198] According to one embodiment, the stimulation control device is configured to generate electrical pulses that amplify sensed action potentials.

[0199] According to one embodiment, the surrounding structure comprises at least one cushioning element, at least one electrode element of the electrode arrangement being arranged on a surface of the cushioning element.

[0200] According to an embodiment, the motor of the first and / or second constriction device is an electric motor.

[0201] According to one embodiment, the motor is a brushless implantable DC motor.

[0202] According to one embodiment, the implantable pump device further comprises a gear system disposed between the motor and the first and second hydraulic pumps, the gear system configured to reduce the speed and increase the force of the motion generated by the motor to mechanically propel the first and second hydraulic pumps at a lower speed and with a greater force.

[0203] According to one embodiment, the motor is configured to generate rotational power and drive the first and second hydraulic pumps with rotational mechanical power.

[0204] According to an embodiment, a rotational power output of the motor is connected to a power input of a gear system, and a rotational power output of the gear system is connected to first and second hydraulic pumps.

[0205] According to one embodiment, at least one of the first and second hydraulic pumps of the first constriction device and / or the second constriction device comprises a gear pump.

[0206] According to an embodiment, at least one of the first and second hydraulic pumps of the first constriction device and / or the second constriction device comprises a peristaltic pump.

[0207] According to one embodiment, at least one of the first and second hydraulic pumps of the first constriction device and / or the second constriction device comprises a pump including at least one compressible hydraulic reservoir.

[0208] According to an embodiment, at least one of the first and second hydraulic pumps of the first constriction device and / or the second constriction device comprises a gerotor pump.

[0209] According to one embodiment, the first hydraulic pump comprises a first gerotor pump. The second hydraulic pump comprises a second gerotor pump. The first constriction device and / or the second constriction device further comprise a common rotating shaft mechanically coupled to a motor. The inner rotor of the first gerotor pump is mechanically connected to the common rotating shaft. The inner rotor of the second gerotor pump is mechanically connected to the common rotating shaft, such that the motor propels the first and second gerotor pumps.

[0210] According to one embodiment, the implantable pump device further comprises an implantable reservoir, and at least one of the first and second hydraulic pumps of the first constriction device and / or the second constriction device is connected to the implantable reservoir.

[0211] According to an embodiment, the first and / or second constriction device further comprises a first implantable reservoir (107) and a second implantable reservoir, and a first hydraulic pump is connected to the first implantable reservoir, and a second hydraulic pump is connected to the second implantable reservoir.

[0212] According to one embodiment, the first and / or second constriction devices further comprise implantable reservoirs, and the first and second hydraulic pumps are connected to the implantable reservoirs for pumping hydraulic fluid from the first reservoir to the first operable hydraulic constriction element and from the second reservoir to the second operable hydraulic constriction element.

[0213] According to one embodiment, the first manipulable hydraulic constriction element of the first constriction device is configured to be inflated, thereby expanding in a first direction toward the bladder to constrict a first portion of the luminal organ to restrict fluid flow therethrough, and the second manipulable hydraulic constriction element of the first constriction device is a support manipulable hydraulic constriction element configured to support the first manipulable hydraulic constriction element when inflated, thereby expanding in the first direction toward the bladder to constrict the first portion of the bladder to restrict fluid flow therethrough.

[0214] According to one embodiment, the first manipulable hydraulic constriction element of the second constriction device is configured to be inflated, thereby expanding in a first direction toward the bladder to restrict fluid flow therethrough and constrict a second portion of the luminal organ for draining urine from the bladder, and the second manipulable hydraulic constriction element of the second constriction device is a support manipulable hydraulic constriction element configured to support the first manipulable hydraulic constriction element when inflated, thereby expanding in a first direction toward the bladder to restrict fluid flow therethrough and constrict a first portion of the bladder for draining urine from the bladder.

[0215] According to one embodiment, the supporting operable hydraulic constriction element is connected to the first operable hydraulic constriction element.

[0216] According to one embodiment, the supporting actuatable hydraulic constriction element is less elastic than the first actuatable hydraulic constriction element.

[0217] According to one embodiment, the first operable hydraulic constriction element of the first and / or second throttle device comprises a lumen surrounded by a resilient wall. The supportable hydraulic constriction element comprises a lumen surrounded by a resilient wall. A portion of the resilient wall of the supportable hydraulic constriction element is thicker than a portion of the resilient wall of the first operable hydraulic constriction element.

[0218] According to one embodiment, the first constriction device and / or the second constriction device further comprises a first pressure sensor configured to sense pressure within the first operable hydraulic constriction element.

[0219] According to one embodiment, the first constriction device and / or the second constriction device further comprises a second pressure sensor configured to sense pressure within the second operable hydraulic constriction element.

[0220] According to embodiments, the implantable pump device further comprises an implantable controller configured to control at least one of a first hydraulic pump of the first constriction device and / or a second constriction device based on input from the first pressure sensor and a second hydraulic pump of the first constriction device and / or a second constriction device based on input from the second pressure sensor.

[0221] According to one embodiment, the first constriction device and / or the second constriction device further comprises a first implantable injection port in fluid communication with the first operable hydraulic constriction element.

[0222] According to one embodiment, the first constriction device and / or the second constriction device further comprises a second implantable injection port in fluid communication with the second operable hydraulic constriction element.

[0223] According to one embodiment, the implantable energy storage device is a rechargeable battery.

[0224] According to one embodiment, the implantable energy storage device is a solid-state battery.

[0225] According to one embodiment, the battery is a thionyl chloride battery.

[0226] According to one embodiment, the implantable energy storage unit is connected to at least one of the first and second hydraulic pumps and configured to power the first and / or second hydraulic pumps after being activated using the capacitor.

[0227] According to one embodiment, the capacitor is configured to store energy for providing bursts of energy to at least one of the first and second hydraulic pumps.

[0228] According to one embodiment, the capacitor is a start capacitor.

[0229] According to one embodiment, the capacitor is a run capacitor.

[0230] According to one embodiment, the capacitor is a dual-run capacitor.

[0231] According to one embodiment, the implantable pump device further comprises a second capacitor configured to be charged by the implantable energy storage unit and to power at least one of the first and second hydraulic pumps.

[0232] According to one embodiment, the capacitor is a supercapacitor.

[0233] According to one embodiment, at least one of the first and second hydraulic pumps comprises an electric motor (M) for operating the hydraulic pump.

[0234] According to one embodiment, the capacitor is further configured to power at least one of a device for applying electrical stimulation to a tissue portion of a patient's body, a CPU for encrypting information, a transceiver unit for communicating with an external unit, a measurement unit or sensor, a data collection unit, a solenoid, a piezoelectric element, and a memory metal unit.

[0235] According to an embodiment, the capacitor is further configured to provide power to the valve.

[0236] According to an embodiment, the capacitor is further configured to provide power to a controller for controlling at least a portion of the implantable pump device.

[0237] According to embodiments, the implantable pump device further comprises an external energy storage unit disposed outside the patient's body and configured to supply energy to the implantable energy storage unit, and an implantable energy receiver electrically connected to the implantable energy storage unit and configured to enable charging of the implantable energy storage unit by the external energy storage unit.

[0238] According to one embodiment, the implantable pump device further comprises a temperature sensor for sensing the temperature of the implantable energy storage unit.

[0239] According to an embodiment, the implantable pump device further comprises a temperature sensor for sensing the temperature of the capacitor.

[0240] According to one embodiment, the sensor is at least one of a Hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor, and a magnetoresistive sensor.

[0241] According to one embodiment, the frequency of the magnetic field generated by the coil is between 9 and 315 kHz.

[0242] According to one embodiment, the frequency of the magnetic field generated by the coil is less than or equal to 125 kHz, preferably less than or equal to 58 kHz.

[0243] According to an embodiment, the control device comprises a receiving unit, and the control device and the external control unit are configured to transmit and / or receive data via the receiving unit and the first coil via magnetic induction.

[0244] According to one embodiment, the receiving unit comprises a sensitive magnetic field detector.

[0245] According to one embodiment, the receiving unit consists of a second coil.

[0246] According to one embodiment, the implantable pump device further comprises an implantable energy storage unit electrically connected to the receiving unit, the implantable energy storage unit being adapted to be charged by the external control unit via the receiving unit.

[0247] According to one embodiment, the implantable energy storage unit is configured to be charged via magnetic induction between a first coil and a second coil.

[0248] According to one embodiment, the receiving unit is configured to control charging of the implantable energy storage unit by controlling the receiving unit's reception of power from the external control unit.

[0249] According to one embodiment, the internal receiving unit is configured to control charging of the implantable energy storage unit by controlling power transfer from the external control unit to the receiving unit.

[0250] According to one embodiment, the implantable pump device further comprises a sensation generator adapted to generate a sensation detectable by the patient's senses, the sensation generator being connected to the control device or an external control unit and configured to generate a sensation when implanted in the patient on demand.

[0251] According to one embodiment, the sensation generator is configured to receive a request from a controller or an implantable pump device.

[0252] According to one embodiment, the sensation generator is configured to receive a request from an external device.

[0253] According to one embodiment, the sensation generator is configured to create a sensation comprising multiple sensory components.

[0254] According to one embodiment, the sensation generator (381) is configured to create a sensation or a sensory component by at least one of vibrating the sensation generator, generating a sound, providing an optical signal, providing an electrical signal, or providing a thermal signal.

[0255] According to one embodiment, the sensation generator is adapted to be implanted in the patient.

[0256] According to one embodiment, the sensation generator is configured to be worn in contact with the patient's skin.

[0257] According to one embodiment, the sensation generator is configured to generate sensations without physical contact with the patient.

[0258] According to one embodiment, the external control device comprises a wireless remote control.

[0259] According to one embodiment, the wireless remote control comprises an external signal transmitter, and the internal receiver is further configured to receive a signal transmitted by the external signal transmitter and to control an operation of the device based on the signal when the processing unit is in an active state.

[0260] According to one embodiment, the signal is selected from the group comprising a sound signal, an ultrasound signal, an electromagnetic signal, an infrared signal, a visible light signal, an ultraviolet signal, a laser signal, a microwave signal, a radio signal, an X-ray signal, a gamma ray signal.

[0261] According to one embodiment, the step of inserting the implantable pump device into the 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 constriction element configured to expand to constrict the bladder to restrict fluid flow therethrough. The second urinary contact element comprises a second operable hydraulic constriction element configured to expand to help unconstrict the bladder to restore fluid flow therethrough. The third urinary contact element comprises at least one cushion element configured to contact the bladder.

[0262] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device including a first operable hydraulic constriction element configured to expand to constrict the bladder to restrict fluid flow therethrough. The implantable pump device further comprises a second operable hydraulic constriction element configured to expand to constrict the bladder to restrict fluid flow therethrough and to drain urine from the bladder. The implantable pump device further comprises an interconnecting fluid conduit fluidly connecting 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 the first portion of the bladder to restrict fluid flow therethrough. 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 the second portion of the bladder to restrict fluid flow therethrough and to drain urine from the bladder. The communicating fluid line is configured to conduct fluid from the first operable hydraulic constriction element to the second operable hydraulic constriction element when pressure in the first operable hydraulic constriction element increases, causing the second operable hydraulic constriction element to further constrict a second portion of the bladder.

[0263] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting the implantable pump device including a first actuable hydraulic constriction element configured to be inflated, thereby expanding in a first direction toward the bladder to constrict a first portion of the bladder to restrict fluid flow therethrough, the implantable pump device further comprising a support actuable hydraulic constriction element configured to support the first actuable hydraulic constriction element when inflated, thereby expanding in the first direction toward the bladder to constrict the first portion of the bladder to restrict fluid flow therethrough.

[0264] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting the implantable pump device including at least two implantable constriction devices, each including a first operable hydraulic constriction element configured to expand to exert pressure on the bladder in a first direction to constrict a first portion of the bladder to restrict fluid flow therethrough. The implantable constriction device further comprises a second operable hydraulic constriction element configured to expand to exert pressure on the bladder in a second direction to constrict the first portion of the bladder to restrict fluid flow therethrough. The implantable constriction device further comprises a first hydraulic system in fluid communication with the first operable hydraulic constriction element and a second hydraulic system in fluid communication with the second operable hydraulic constriction element. The first and second operable hydraulic constriction elements are independently adjustable.

[0265] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device comprising at least two implantable constriction devices. Each implantable constriction device comprises an actuatable hydraulic constriction element configured to inflate to apply pressure to the bladder. Each implantable constriction device further comprises a hydraulic reservoir for holding hydraulic fluid. Each implantable constriction device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the actuatable hydraulic constriction element. Each implantable constriction device further comprises a first fluid conduit forming a fluid connection between the hydraulic reservoir and the hydraulic pump. Each implantable constriction device further comprises a second fluid conduit forming a fluid connection between the hydraulic pump and the actuatable hydraulic constriction element. Each implantable constriction device further comprises an injection port for injecting and removing hydraulic fluid from the implantable constriction device when implanted. Each implantable constriction device further includes a third fluid conduit forming a fluid connection between the injection port and at least one of the second fluid conduit and the operable hydraulic constriction element so that hydraulic fluid can be removed from the operable hydraulic constriction element through the injection port.

[0266] According to one embodiment, the step of inserting an implantable pump device into the patient's body includes inserting an implantable pump device including at least two implantable constriction devices. Each implantable constriction device includes an actuatable hydraulic constriction element configured to expand to apply pressure to the bladder. Each implantable constriction device further includes a hydraulic reservoir for holding hydraulic fluid. Each implantable constriction device further includes a hydraulic pump for pumping fluid from the hydraulic reservoir to the actuatable hydraulic constriction element. Each implantable constriction device further includes a first fluid conduit forming a fluid connection between the hydraulic reservoir and the hydraulic pump. Each implantable constriction device further includes an electrode arrangement disposed between the implantable constriction device and the bladder, configured to engage and electrically stimulate bladder muscle tissue to exercise the muscle tissue and improve the long-term implantation condition of the implantable constriction device.

[0267] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device comprising at least two implantable constriction devices. Each implantable constriction device comprises a first actuable hydraulic constriction element configured to expand to exert pressure on the bladder. Each implantable constriction device further comprises a second actuable hydraulic constriction element configured to expand to exert pressure on the bladder. Each implantable constriction device further comprises a first hydraulic pump for pumping fluid to the actuable hydraulic constriction element. Each implantable constriction device further comprises a second hydraulic pump for pumping fluid to the actuable hydraulic constriction element. Each implantable constriction device further comprises a motor. The motor is mechanically connected to the first and second hydraulic pumps for driving the first and second hydraulic pumps.

[0268] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device comprising at least two implantable constriction devices. Each implantable constriction device comprises an actuatable hydraulic constriction element configured to inflate to apply pressure to the bladder. Each implantable constriction device further comprises a pressure sensor configured to sense pressure within the actuatable hydraulic constriction element. Each implantable constriction device further comprises a hydraulic pump for pumping hydraulic fluid to the actuatable hydraulic constriction element. Each implantable constriction device further comprises a controller configured to receive a pressure sensor input from the pressure sensor and control the hydraulic pump based on the received pressure sensor input. The pressure sensor comprises a diaphragm, the diaphragm in fluid communication with the hydraulic fluid within the actuatable hydraulic constriction element. The diaphragm is further connected to a pressure sensing element of the pressure sensor, the pressure sensing element being isolated from the hydraulic fluid within the actuatable hydraulic constriction element by the diaphragm.

[0269] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device comprising at least two implantable constriction devices. Each implantable constriction device comprises an actuatable hydraulic constriction element configured to expand to apply pressure to the bladder. Each implantable constriction device further comprises a hydraulic pump for pumping hydraulic fluid to the actuatable hydraulic constriction element. The hydraulic pump comprises a compressible reservoir configured to hold hydraulic fluid for movement to the actuatable hydraulic constriction element. Each implantable constriction device further comprises a motor having a shaft. The motor is configured to generate a radial force upon rotation of the shaft. Each implantable constriction device further comprises a transmission configured to transfer the radial force to a substantially axial force of the shaft for compressing the compressible reservoir. Each implantable constriction device further comprises at least one bearing for the shaft. The bearing is configured to withstand at least half of the axial force caused by compression of the reservoir to reduce axial load on at least one of the motor and the gear system.

[0270] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device comprising at least two implantable constriction devices. Each implantable constriction device comprises at least one implantable, manipulable hydraulic constriction element. Each implantable, manipulable hydraulic constriction element includes a contact wall configured to engage the bladder to exert a force on the bladder. Each implantable, manipulable hydraulic constriction element further comprises a retaining wall configured to be connected to a retaining structure to retain the force exerted on the bladder so as to constrict the bladder. Each implantable, manipulable hydraulic constriction element further comprises a connecting wall connecting the contact wall to the retaining wall. A first portion of the connecting wall is connected to the contact wall. A second portion of the connecting wall is connected to the retaining wall. The first portion of the connecting wall is more elastic than the second portion of the connecting wall.

[0271] According to one embodiment, the step of inserting an implantable pumping device into the patient's body comprises inserting an implantable pumping device comprising at least two implantable constriction devices. Each implantable constriction device comprises an actuatable hydraulic constriction element configured to expand to apply pressure to the bladder. Each implantable constriction device further comprises a hydraulic pump for pumping hydraulic fluid to the actuatable hydraulic constriction element. Each implantable constriction device comprises an implantable energy storage unit. Each implantable constriction device comprises a capacitor connected to the implantable energy storage unit and connected to the hydraulic pump. The capacitor is configured to be charged by the implantable energy storage unit to power the hydraulic pump.

[0272] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable pump device comprising at least two implantable constriction devices. Each implantable constriction device comprises an actuatable hydraulic constriction element configured to expand to apply pressure to the bladder. Each implantable constriction device comprises a hydraulic pump for pumping hydraulic fluid to the actuatable hydraulic constriction element. Each implantable constriction device comprises a controller configured to control the hydraulic pump. The controller comprises a sensor adapted to detect a magnetic field and a processing unit having a sleep mode and an active mode. Each implantable constriction device comprises an external control unit adapted to be disposed outside the patient's body, the external control unit comprising a first coil adapted to generate a magnetic field detectable by the internal sensor. The controller is further configured to set the processing unit to the active mode in response to the detected magnetic field exceeding a predetermined value.

[0273] According to an embodiment, the step of positioning the implantable pump device relative to the bladder comprises positioning the implantable pump device around the patient's bladder.

[0274] According to one embodiment, the step of connecting and positioning the implantable pump device to the bladder comprises closing a locking or securing device of the implantable pump device around the bladder to secure the implantable pump device to the patient's bladder.

[0275] According to one embodiment, the step of positioning the implantable pump device relative to the bladder comprises securing the implantable pump device with at least one of sutures, staples, and tissue growth promoting structures.

[0276] According to one embodiment, the step of inserting the implantable pump device into the patient's body comprises inserting an implantable control device into the patient's body and securing the implantable control device to tissue or bone within the patient's body.

[0277] According to one embodiment, the step of inserting the implantable pump device into the patient's body includes inserting an operating device including at least one of an implantable hydraulic pump and an implantable valve, and securing the implantable operating device to tissue or bone within the patient's body.

[0278] According to one embodiment, the method further comprises the step of implanting and securing at least one injection port in fluid communication with a manipulation device.

[0279] According to an embodiment, the step of securing the at least one injection port includes securing the injection port subcutaneously.

[0280] According to one embodiment, the method further comprises the step of calibrating the fluid level within the implantable pump device.

[0281] According to one embodiment, the method further includes calibrating at least one of the pressure the implantable pump device exerts on the bladder, the time the implantable pump device remains closed after activation, the rate at which the implantable pump device should constrict the bladder, the pressure the implantable pump device exerts on the bladder relative to the patient's blood pressure, the pressure the implantable pump device exerts on the bladder via a pressure-sensitive catheter, the pressure acting on the bladder relative to the patient's blood pressure, and the pressure the implantable pump device exerts on the bladder via a pressure-sensitive catheter.

[0282] According to one embodiment, the method further includes testing at least one of a full catheter mode, a feedback function by providing sensory feedback to the patient, a post-operative mode to allow healing, a post-operative mode to allow growth of fibrotic tissue, and electrical stimulation of tissue of the bladder.

[0283] According to one embodiment, the method further includes positioning a second portion of the implantable, energized medical device between the peritoneum and the layer of abdominal wall musculature. The method further includes positioning a first portion of the implantable, energized medical device between the patient's skin and the layer of abdominal wall musculature, the first and second portions being connected by a connecting portion extending through at least one layer of abdominal wall musculature. The method further includes positioning a transmission member configured to transmit at least one of energy and force from the second portion to the implantable pump device at least partially between the peritoneum and the layer of abdominal wall musculature, the transmission member being configured to transmit at least one of energy and force from the second portion to the implantable pump device, the transmission member being positioned outside the peritoneum.

[0284] According to an embodiment, the step of measuring the pressure in the first and / or second implantable hydraulic constriction elements when substantially no pressure is applied to the bladder further comprises comparing the measured pressure to atmospheric pressure.

[0285] According to one embodiment, the step of comparing the measured pressure with atmospheric pressure comprises measuring the atmospheric pressure using a pressure sensor connected to a signal transmitter located outside the patient's body.

[0286] According to one embodiment, the step of increasing the pressure of the first and second implantable hydraulic constriction elements to a defined level comprises expanding the first and / or second implantable hydraulic constriction elements to a defined cross-sectional distance.

[0287] According to one embodiment, the method further comprises measuring the pressure in the first and / or second implantable hydraulic constriction elements when the pressure in the implantable hydraulic constriction elements increases.

[0288] According to an embodiment, the steps of measuring the pressure in the first and / or second implantable hydraulic constriction elements when there is substantially no pressure on the bladder and measuring the pressure in the first and / or second implantable hydraulic constriction elements when the pressure in the implantable hydraulic constriction elements increases are performed using the same pressure sensor.

[0289] According to one embodiment, the method further comprises, in the control device, creating an absolute pressure by subtracting a pressure in the first and / or second implantable hydraulic constriction element when substantially no pressure is acting on the bladder from a pressure in the implantable hydraulic constriction element when the pressure in the hydraulic constriction element increases, and controlling the operating device comprises controlling the operating device based on the absolute pressure.

[0290] According to one embodiment, the computing unit is further configured to compare the measured pressure with atmospheric pressure.

[0291] According to one embodiment, the controller is further configured to receive a pressure signal from a pressure sensor located external to the patient's body and compare the measured pressure with the pressure received in the pressure signal.

[0292] According to one embodiment, the controller is configured to increase the pressure in the first and / or second implantable hydraulic constriction elements based on the measured pressure.

[0293] According to one embodiment, the control device is configured to increase pressure within the first and / or second implantable hydraulic constriction elements to a defined cross-sectional distance.

[0294] According to one embodiment, the coating comprises at least one layer of a biomaterial.

[0295] According to one embodiment, the biomaterial comprises at least one drug or substance having antithrombotic and / or antibacterial and / or antiplatelet properties.

[0296] According to one embodiment, the biomaterial is fibrin-based.

[0297] According to one embodiment, the implantable pump device further comprises a second coating disposed over the first coating.

[0298] According to an embodiment, the second coating is a different biological material than said first coating.

[0299] According to one embodiment, the first coating comprises a perfluorocarbon layer chemically attached to the surface, and the second coating comprises a liquid perfluorocarbon layer.

[0300] According to one embodiment, the coating comprises a drug encapsulated in a porous material.

[0301] According to one embodiment, the surface comprises a metal.

[0302] According to one embodiment, the metal comprises at least one selected from titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin, or lead.

[0303] According to one embodiment, the surface comprises a micropattern.

[0304] According to one embodiment, the micropattern is etched into the surface before insertion into the body.

[0305] According to one embodiment, the implantable pump device further comprises a layer of biomaterial coated on the micropattern.

[0306] According to one embodiment, the connecting portion includes a flange defining a fourth cross-sectional area, the flange being prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0307] According to one embodiment, the flanges project in a direction parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0308] According to one embodiment, the flange comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0309] According to one embodiment, the connecting portion comprises at least one protruding element defining a fourth cross-sectional area and configured to prevent the at least one protruding element from moving through an opening in the tissue portion, thereby enabling the second portion and the connecting portion to be held in place by the patient's tissue portion even when the first portion is detached from the connecting portion.

[0310] According to one embodiment, the at least one projecting element projects in a direction parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0311] According to one embodiment, the at least one protruding element comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0312] According to an embodiment, the link comprises at least two projecting elements defining a fourth cross-sectional area.

[0313] According to one embodiment, the at least two projecting elements are arranged symmetrically about the central axis of the connecting part.

[0314] According to one embodiment, the at least two projecting elements are arranged asymmetrically relative to the central axis of the connecting part.

[0315] According to embodiments, 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 energized medical device being held in place by the tissue portion.

[0316] According to one embodiment, the connecting portion comprises a hollow portion.

[0317] According to one embodiment, the hollow portion provides a passageway between the first and second portions.

[0318] According to an embodiment, the first part is detachably connected to the connection part by at least one of a mechanical connection and a magnetic connection.

[0319] According to one embodiment, the first portion is detachably coupled to the coupling portion by at least one of a thread and corresponding groove, a screw, a self-locking element, a twist-lock joint, and a spring-loaded locking mechanism.

[0320] According to one embodiment, the at least one projecting element has a height in a direction perpendicular to the fourth plane that is smaller than the height of the first portion in said direction.

[0321] According to one embodiment, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than half of said height of said first portion in said direction.

[0322] According to one embodiment, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than one-fourth of said height of said first portion in said direction.

[0323] According to one embodiment, at least one projecting element has a height in said direction perpendicular to the fourth plane that is less than one tenth of said height of said first portion in said direction.

[0324] According to one embodiment, the diameter of at least one protruding element in the fourth plane is one of: 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.

[0325] According to one embodiment, the cross-sectional area of ​​at least one protruding element in the fourth plane is one of: 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.

[0326] According to one embodiment, the height of the at least one projecting element in said direction perpendicular to the fourth plane is less than half the height of the connecting portion in said direction.

[0327] According to one embodiment, at least one projecting element has a height in said direction perpendicular to the fourth plane that is less than one-fourth of said height of the connecting portion in said direction.

[0328] According to one embodiment, at least one projecting element has a height in said direction perpendicular to the fourth plane that is less than one tenth of said height of the connecting portion in said direction.

[0329] According to one embodiment, the first portion comprises a first wireless energy receiver configured to receive energy wirelessly transmitted from an external wireless energy transmitter.

[0330] According to one embodiment, the first part constitutes an internal wireless energy transmitter.

[0331] According to one embodiment, the second part comprises a second wireless energy receiver.

[0332] According to one embodiment, the first part constitutes a first energy storage unit.

[0333] According to an embodiment, the second part constitutes a second energy storage unit.

[0334] According to an embodiment, at least one of the first and second energy storage units is a solid-state battery.

[0335] According to one embodiment, the solid state battery is a thionyl chloride battery.

[0336] According to one embodiment, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0337] According to an embodiment, the first part comprises a first control device including at least one processing unit.

[0338] According to an embodiment, the second part comprises a second control device including at least one processing unit.

[0339] According to an embodiment, at least one of the first and second control devices is connected to a wireless transceiver for wireless communication with an external device.

[0340] According to an embodiment, the first control device is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device, and the first control device is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion.

[0341] According to an embodiment, the second control device is connected to a second wireless communication receiver for receiving wireless communication from the first part.

[0342] According to one embodiment, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0343] According to one embodiment, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0344] According to one embodiment, at least one of the coils is embedded in a ceramic material.

[0345] According to one embodiment, the medical device further comprises a housing configured to enclose at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0346] According to one embodiment, the portion of the housing made from ceramic material consists of at least one coil embedded in the ceramic material.

[0347] According to one embodiment, the medical device further comprises a housing configured to enclose at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0348] According to an embodiment, the medical device further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0349] According to one embodiment, the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.

[0350] According to one embodiment, the sensor is configured to sense at least one of a temperature of the implantable energized medical device or body-engaged portion, a parameter related to power consumption of the implantable energized medical device or body-engaged portion, a parameter related to the status of at least one of the first and second energy storage units, a parameter related to wireless transfer of energy from an energy source external to the patient's body, and fluid pressure.

[0351] According to one embodiment, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0352] According to one embodiment, the sensor is configured to sense at least one of a parameter related to the patient's swallowing, local temperature, systemic temperature, blood saturation, blood oxygenation, blood pressure, a parameter related to an ischemic marker, and pH.

[0353] According to one embodiment, the sensor configured to sense a parameter associated with the patient's swallowing comprises at least one of a motility sensor, an acoustic sensor, an optical sensor, and a strain sensor.

[0354] According to one embodiment, the sensor configured to sense pH is configured to sense acidity in the stomach.

[0355] According to one embodiment, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0356] According to an embodiment, the second part constitutes at least part of a manipulation device for manipulating the implantable body engaging part.

[0357] According to one embodiment, the second part consists of at least one electric motor.

[0358] According to one embodiment, the second part comprises a transmission configured to reduce the speed and increase the force of the motion generated by the electric motor.

[0359] According to one embodiment, the transmission is configured to transfer a high speed, weak force to a low speed, strong force.

[0360] According to one embodiment, the transmission is configured to convert rotational force into linear force.

[0361] According to one embodiment, the transmission comprises a gear system.

[0362] According to one embodiment, the second part comprises a magnetic coupling for transmitting mechanical work from the electric motor through one of a barrier separating a first chamber of the second part from a second chamber of the second part, and a housing surrounding at least the second part.

[0363] According to one embodiment, the second part comprises at least one hydraulic pump.

[0364] According to one embodiment, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0365] According to an embodiment, the medical device further includes a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor being configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0366] According to one embodiment, at least one of the first and second portions includes a sensation generator adapted to generate a sensation detectable by the patient's senses.

[0367] According to one embodiment, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0368] According to one embodiment, the second portion comprises a force transmission element configured to hydraulically transmit force from the second portion to the implant engaging portion.

[0369] According to an embodiment, the second part comprises at least one lead for transmitting electrical energy and / or information from the second part to the implanted body engaging part.

[0370] According to one embodiment, the first portion comprises an injection port for injecting a fluid into the first portion.

[0371] According to one embodiment, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0372] According to one embodiment, the conduit is arranged to extend through a hollow portion of the coupling.

[0373] According to one embodiment, the second portion comprises a first chamber and a second chamber separated from one another, the first chamber comprising a first liquid and the second chamber comprising a second liquid, the second liquid being a hydraulic fluid configured to transmit a force to the implantable element configured to exert a force on a body part of a patient.

[0374] According to one embodiment, the walls of the first chamber are elastic to allow expansion of the first chamber.

[0375] According to an embodiment, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuatable implant element configured to exert a force on the patient's body part, and a second hydraulic system in fluid communication with a second hydraulically actuatable implant element configured to exert a force on the patient's body part, the first and second hydraulically actuatable implant elements being adjustable independently of each other.

[0376] According to one embodiment, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0377] According to one embodiment, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0378] According to an embodiment, the medical device further comprises a first pressure sensor configured to sense pressure in the first hydraulic system and a second pressure sensor configured to sense pressure in the second hydraulic system.

[0379] According to one embodiment, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0380] According to one embodiment, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0381] According to an embodiment, the fourth plane is parallel to the primary plane of extension of the tissue.

[0382] According to one embodiment, the transmission member is configured to transmit mechanical force from the second portion to the body engagement portion.

[0383] According to one embodiment, the transmission member is configured to transmit hydraulic force from the second portion to the body engagement portion.

[0384] According to one embodiment, the transmission member is configured to transmit electrical energy force from the second portion to the body engagement portion.

[0385] According to an embodiment, the transfer member is configured to transfer data between the second part and the body engagement portion.

[0386] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member at least partially between the peritoneum and a layer of abdominal wall muscle tissue such that at least half of the length of the transfer member is positioned outside the patient's peritoneum.

[0387] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member at least partially between the peritoneum and a layer of abdominal wall muscle tissue such that at least two-thirds of the length of the transfer member is positioned outside the patient's peritoneum.

[0388] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member entirely outside of the patient's peritoneum.

[0389] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion outside the peritoneum to a region between the patient's thorax and peritoneum.

[0390] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the subperitoneal space outside the peritoneum.

[0391] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member outside the peritoneum to extend from the second portion to the bladder.

[0392] According to one embodiment, the step of positioning the transfer member comprises positioning the transfer member outside the peritoneum to extend from the second portion to the urethra.

[0393] According to one embodiment, the step of positioning the second portion of the implantable energized medical device between the peritoneum and the layer of abdominal wall musculature comprises positioning the second portion between the first and second layers of abdominal wall musculature.

[0394] According to one embodiment, the step of disposing the second part comprises disposing the second part comprising an electric motor.

[0395] According to one embodiment, the step of disposing the second portion comprises disposing the second portion comprising a hydraulic pump.

[0396] According to one embodiment, the step of disposing the second portion comprises disposing the second portion comprising an energy storage unit.

[0397] According to one embodiment, the step of disposing the second portion comprises disposing the second portion including a receiver for wirelessly receiving at least one of energy and communications.

[0398] According to one embodiment, the step of disposing the first portion comprises disposing the first portion including a transmitter for wirelessly transmitting at least one of energy and communications.

[0399] According to one embodiment, the step of disposing the second part comprises disposing the second part to comprise a control device responsible for controlling the energized medical device.

[0400] According to an embodiment, the second portion is elongate and has a length axis extending substantially in an elongate direction of the second portion, and positioning the second portion includes positioning the second portion such that the length axis is substantially parallel to a craniocaudal axis of the patient.

[0401] According to one embodiment, the second portion is elongate and has a major axis extending substantially in a direction of elongation of the second portion, and positioning the second portion includes positioning the second portion such that the major axis is substantially perpendicular to the craniocaudal axis of the patient.

[0402] According to one embodiment, the second portion is elongated and has a major axis extending substantially in the elongated direction of the second portion, and the step of positioning the second portion includes piercing a layer of muscle tissue of the stomach wall in the direction of the major axis of the second portion and rocking or angling the second portion after piercing.

[0403] According to one embodiment, the step of placing a first portion of the implantable, energized medical device between the patient's skin and a layer of muscle tissue of the abdominal wall comprises placing the first portion in subcutaneous tissue.

[0404] According to one embodiment, the step of positioning a first portion of the implantable energized medical device between the patient's skin and the layer of abdominal wall musculature comprises positioning the first portion between the first and second layers of abdominal wall musculature.

[0405] According to one embodiment, the step of disposing the first portion comprises disposing the first portion comprising an energy storage unit.

[0406] According to one embodiment, the step of disposing the first portion comprises disposing the first portion including a receiver for wirelessly receiving at least one of energy and communications.

[0407] According to one embodiment, the step of disposing the first portion comprises disposing the first portion including a transmitter for wirelessly transmitting at least one of energy and communications.

[0408] According to one embodiment, the step of disposing the first portion comprises disposing the first portion to comprise a control device responsible for controlling the energized medical device.

[0409] According to an embodiment, the first portion is elongate and has a major axis extending substantially in a direction of elongation of the first portion, and the step of positioning the first portion includes positioning the first portion such that the major axis is substantially parallel to a craniocaudal axis of the patient.

[0410] According to an embodiment, the first portion is elongate and has a major axis extending substantially in a direction of elongation of the first portion, and the step of positioning the first portion includes positioning the first portion such that the major axis is substantially perpendicular to a craniocaudal axis of the patient.

[0411] According to one embodiment, the first portion is elongated and has a first portion major axis extending substantially in the direction of elongation of the first portion, the second portion is elongated and has a second portion major axis extending substantially in the direction of elongation of the second portion, and the step of positioning the first portion and the second portion comprises positioning the first portion and the second portion such that the length axes of the first portion and the second portion are positioned at an angle of greater than 30° relative to each other.

[0412] According to one embodiment, the step of positioning the first and second portions comprises positioning the first and second portions such that a length axis of the first portion and a length axis of the second portion are positioned at an angle of greater than 45° relative to each other.

[0413] According to one embodiment, the method of implanting an energized medical device further includes placing a linking portion through at least one layer of abdominal wall muscle tissue.

[0414] According to an embodiment, the first portion, the second portion and the linking portion are part of a single unit.

[0415] According to one embodiment, the method of implanting an energized medical device further comprises the step of in situ coupling the first portion to the coupling portion.

[0416] According to one embodiment, the method of implanting an energized medical device further comprises the step of in situ coupling the second portion to the coupling portion.

[0417] According to one embodiment, the method of implanting an energized medical device further includes coupling a transfer member to the first portion.

[0418] According to one embodiment, the method of implanting an energized medical device further comprises coupling a transfer member to the body engaging portion.

[0419] According to one embodiment, the body engaging portion comprises a medical device for stretching the stomach wall to induce a feeling of fullness.

[0420] According to one embodiment, the body engaging portion comprises a constriction device configured to constrict a luminal organ of a patient.

[0421] According to one embodiment, the body engaging portion comprises an implantable constriction device.

[0422] According to one embodiment, an implantable constriction device comprises an implantable constriction device for constricting a luminal organ of a patient.

[0423] According to one embodiment, the body engaging portion comprises an implantable element for actively emptying the patient's bladder.

[0424] According to one embodiment, the implantable element for actively emptying a patient's bladder is configured to empty the patient's bladder by compressing the bladder from the outside thereof.

[0425] According to one embodiment, the body engaging portion comprises an element for electrically stimulating a tissue portion of the patient.

[0426] According to one embodiment, the first wireless transceiver comprises a UWB transceiver.

[0427] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of powering energy consuming components of the implantable medical device and charging the implantable energy storage unit.

[0428] According to one embodiment, the second network protocol is a standard network protocol, which may be one of the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0429] According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.

[0430] According to one embodiment, the external device is further configured to communicate with a second external device using said at least one wireless transceiver.

[0431] 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.

[0432] According to one embodiment, the communication range of the first network protocol is less than the communication range of the second network protocol.

[0433] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0434] According to one embodiment, the external device is configured to authenticate the implantable medical device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold.

[0435] 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.

[0436] According to one embodiment, the external device is one selected from a wearable external device and a handset.

[0437] According to one embodiment, the first wireless transceiver comprises a UWB transceiver.

[0438] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of powering energy consuming components of the implantable medical device and charging the implantable energy storage unit.

[0439] According to one embodiment, the second network protocol is a standard network protocol, such as selected from the list of a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0440] According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.

[0441] According to one embodiment, the implantable medical device is further configured to communicate with a second external device using said at least one wireless transceiver.

[0442] 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.

[0443] According to one embodiment, the communication range of the first network protocol is less than the communication range of the second network protocol.

[0444] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0445] According to one embodiment, the implantable medical device is configured to authenticate the external device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold.

[0446] According to one embodiment, the implantable medical device is configured to allow transfer of data between the implantable medical device and the external device after the external device has been authenticated.

[0447] 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 a patient's heart, a device for assisting the pumping function comprising a turbine bump placed within a patient's blood vessel to assist the pumping function of the heart, an steerable prosthetic heart valve, an steerable prosthetic heart valve for increasing blood flow to a coronary artery, an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and relocating an injection site, an implantable drug delivery device for injecting potency enhancing drugs into a patient's erectile tissue, all from within the patient's body, a hydraulic, mechanical, and / or electrical constriction implant, an steerable volume filling device, an steerable gastric band, an steerable implant for stretching a patient's stomach wall to create a feeling of fullness, an implant configured to sense how often a patient takes in food, an steerable cosmetic implant, an steerable cosmetic implant for adjusting the shape and / or size of a patient's breast area, an implant for controlling a medical device for emptying the bladder, an implant to prevent urinary leakage, an implant to prevent anal incontinence, an implant to control fecal evacuation, an aneurysm. implants to monitor, implants to prevent dilation of aneurysms, implants to lubricate joints, implants to affect blood flow to a patient's erectile tissue, implants to simulate the filling of erectile tissue, implants with reservoirs to hold fluids, implants to store and / or empty fluid reservoirs or surgically created reservoirs, implants that communicate with a database outside the body, implants programmable from outside the body, implants programmable from outside the body by wireless signals, implants to treat impotence, implants to control the flow of eggs in the uterine tract, implants to control the flow of sperm in the uterine tract, implants to control the flow of sperm in the vas deferens, implants for preventing the transport of sperm in the vas deferens, implants to treat osteoarthritis, implants to test internal body parameters, implants to control certain treatment parameters from within the body, implants to control body parameters from within the body, implants to control blood pressure, implants to control blood pressure by affecting the dilation of the renal arteries, implants to control drug treatment parameters,implants for controlling parameters in the blood, implants for adjusting or replacing bone portions of a patient's body, implants for replacing an organ or part of an organ or its function in a patient, 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 exercise muscles with electrical or mechanical stimulation, implants configured to empty a portion of the intestine on command, an operable implant configured for insertion into a patient's stomach to reduce the stomach volume substantially below the volume of the device, implants configured to compress the bladder to empty it from the patient's body, implants configured to expel fluids from the patient's body, implants configured to actively lubricate a joint with an added lubricating fluid, implants configured to remove blood clots and particles from a patient's bloodstream, implants configured to lengthen or straighten a patient's bones to reduce scoliosis, devices for focused stimulation of the brain from several locations, an artificial stomach to 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 vascular ampulla to cause temporary constriction.

[0448] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0449] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0450] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0451] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0452] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0453] According to one embodiment, the wireless communication unit comprises a wireless transceiver for wirelessly transmitting control commands to the implantable medical device and a control interface as a remote display portal to the patient display device.

[0454] According to one embodiment, the wireless communication unit comprises a first wireless transceiver for wirelessly transmitting control commands to the implantable medical device and a second wireless transceiver for wirelessly transmitting a control interface to the patient display device.

[0455] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient display device using standard network protocols.

[0456] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the implantable medical device using a proprietary network protocol.

[0457] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0458] According to one embodiment, at least one of the first and second wireless transceivers comprises a Bluetooth transceiver.

[0459] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0460] According to one embodiment, at least one of the first and second wireless transceivers comprises an UWB transceiver.

[0461] 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 a 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.

[0462] According to one embodiment, the first wireless transceiver is configured for transcutaneous energy transmission for at least one of powering energy consuming components of the implantable medical device and charging the implantable energy storage unit.

[0463] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0464] According to one embodiment, the communication range of the first wireless transceiver is less than the communication range of the second wireless transceiver.

[0465] According to one embodiment, the patient external device is configured to authenticate the implantable medical device when the distance between the patient external device and the implantable medical device is less than a predetermined threshold, the patient external device is configured to be authenticated by the implantable medical device when the distance between the patient external device and the implantable medical device is less than a predetermined threshold, the patient external device is configured to authenticate the patient display when the distance between the patient external device and the patient display is less than a predetermined threshold, or the patient external device is configured to be authenticated by the implantable medical device when the distance between the patient external device and the patient display is less than a predetermined threshold.

[0466] According to one embodiment, the patient external device is configured to enable data transfer between the patient external device and at least one of the patient external device and the implantable medical device and the patient display device based on authentication.

[0467] According to one embodiment, the computing unit is configured to encrypt at least one of the control interface and the control commands.

[0468] According to one embodiment, the implantable medical device comprises at least one of an external cardiac compression device, a device for assisting the pumping function of a patient's heart, a device for assisting the pumping function comprising a turbine bump placed within a patient's blood vessel to assist the pumping function of the heart, a steerable prosthetic heart valve, and a steerable prosthetic heart valve for increasing blood flow to a coronary artery. Implantable drug delivery devices, implantable drug delivery devices for injecting directly into blood vessels from within a patient's body and repositioning an injection site, implantable drug delivery devices for injecting potency enhancing drugs into a patient's erectile tissue, hydraulic, mechanical, and / or electrical constriction implants, steerable volume filling devices, steerable gastric bands, steerable implants for stretching a patient's stomach wall to create a feeling of fullness, implants configured to sense the frequency with which a patient takes food, steerable cosmetic implants, steerable cosmetic implants for adjusting the shape and / or size of a patient's breast area, implant controlled medical devices for emptying the bladder, implants for preventing urinary leakage, implants for preventing anal incontinence, implants for controlling fecal evacuation, implants for monitoring aneurysms, implants for preventing aneurysm dilation, implants for lubricating joints, implants that affect blood flow to a patient's erectile tissue, implants that simulate constriction of erectile tissue Plant, implant with reservoir for holding bodily fluids, implant for storing and / or emptying internal or surgically created reservoirs, implant for communicating with a database outside the body, implant programmable from outside the body, implant programmable by wireless signals from outside the body, implant for treating impotence, implant for controlling the flow of eggs in the uterine tract, implant for controlling the flow of sperm in the uterine tract, implant for controlling the flow of sperm in the vas deferens, implant for obstructing the transport of sperm in the vas deferens, implant for treating osteoarthritis, implant for testing internal body parameters, implant for controlling certain treatment parameters from the body, implant for controlling bodily parameters from the body, implant for controlling blood pressure, implant for controlling blood pressure by affecting the dilation of the renal arteries, implant for controlling drug treatment parameters, implant for controlling parameters in the blood,implants for adjusting or replacing bony portions of a patient's body, implants for replacing an organ or part of an organ or its function in a patient, 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 exercise muscles by electrical or mechanical stimulation, implants configured to empty a portion of the intestine on command, an operable implant configured to be inserted into a patient's stomach to reduce the volume of the stomach substantially below the volume of the device, an implant configured to empty the bladder from a patient's body by compressing the bladder, an implant configured to expel fluids from a patient's body, an implant configured to actively lubricate a joint with an added lubricating fluid, an implant configured to remove blood clots and particles from a patient's bloodstream, an implant configured to lengthen or straighten a patient's bones to reduce scoliosis, a device for focused stimulation of the brain from several locations, an artificial stomach to replace the function of a natural stomach, an implant configured to adjust the position of the female urinary tract or bladder neck, an implant configured to stimulate the vascular ampulla to cause temporary constriction.

[0469] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0470] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0471] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0472] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0473] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0474] According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit configured to be disabled to enable at least one of wirelessly receiving the implant control interface as a remote display portal from the patient remote external device and wirelessly transmitting implant control user inputs to the patient remote external device.

[0475] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient remote external device using a standard network protocol, which may be one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0476] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient remote external device using a proprietary network protocol.

[0477] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0478] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0479] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0480] 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.

[0481] 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.

[0482] According to one embodiment, the patient display device is a wearable external device or a handheld device.

[0483] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0484] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0485] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0486] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0487] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0488] According to one embodiment, the computing unit is configured to encrypt at least one of the control interface and the control commands.

[0489] According to one embodiment, the patient display device is configured to encrypt user input.

[0490] 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.

[0491] 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.

[0492] According to one embodiment, the server is configured to act as a router that forwards encrypted control interfaces from the patient remote external device to the patient display device without decryption.

[0493] According to one embodiment of the communication system or patient display device, the implantable medical device comprises at least one of an external cardiac compression device, a device for assisting the pumping function of the patient's heart, a device for assisting the pumping function comprising a turbine bump placed within the patient's blood vessel to assist the pumping function of the heart, an operable prosthetic heart valve, and an operable prosthetic heart valve for increasing blood flow to a coronary artery. Implantable drug delivery devices, implantable drug delivery devices for injecting directly into blood vessels from within a patient's body and repositioning an injection site, implantable drug delivery devices for injecting potency enhancing drugs into a patient's erectile tissue, hydraulic, mechanical, and / or electrical constriction implants, steerable volume filling devices, steerable gastric bands, steerable implants for stretching a patient's stomach wall to create a feeling of fullness, implants configured to sense the frequency with which a patient takes food, steerable cosmetic implants, steerable cosmetic implants for adjusting the shape and / or size of a patient's breast area, implant controlled medical devices for emptying the bladder, implants to prevent urinary leakage, implants to prevent anal incontinence, implants to control fecal evacuation, implants to monitor aneurysms, implants to prevent aneurysm dilation, implants to lubricate joints, implants that affect blood flow to a patient's erectile tissue, constriction of erectile tissue implants that simulate fluid retention, implants with reservoirs that hold bodily fluids, implants that store and / or empty internal or surgically created reservoirs, implants that communicate with a database outside the body, implants that are programmable from outside the body, implants that are programmable by wireless signals from outside the body, implants that treat impotence, implants that control the flow of eggs in the uterine tract, implants that control the flow of sperm in the uterine tract, implants that control the flow of sperm in the vas deferens, implants for obstructing the transport of sperm in the vas deferens, implants that treat osteoarthritis, implants that test internal body parameters, implants that control certain treatment parameters from within the body, implants that control bodily parameters from within the body, implants that control blood pressure, implants that control blood pressure by affecting the dilation of the renal arteries, implants that control drug treatment parameters,implants for controlling parameters in the blood, implants for adjusting or replacing bone portions of a patient's body, implants for replacing an organ or part of an organ or its function in a patient, 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 exercise muscles by electrical or mechanical stimulation, implants configured to empty a portion of the intestine on command, an operable implant configured to be inserted into a patient's stomach to reduce the volume of the stomach substantially below the volume of the device, implants configured to empty the bladder from the patient's body by compressing the bladder, implants configured to expel fluids from the patient's body, implants configured to actively lubricate joints with added lubricating fluid, implants configured to remove blood clots and particles from the patient's bloodstream, implants configured to lengthen or straighten a patient's bones to reduce scoliosis, devices for focused stimulation of the brain from several locations, an artificial stomach to 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 vascular ampulla to cause temporary constriction.

[0494] According to one embodiment, the communication system further comprises a server. The server may comprise a wireless communication unit configured to wirelessly receive the implant control interface received from the patient remote external device and wirelessly transmit the implant control interface to the patient display device as a remote display portal. The wireless communication unit is further configured to wirelessly receive the implant control user input from the patient EID external device and wirelessly transmit the implant control user input to the patient display device.

[0495] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0496] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0497] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0498] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0499] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0500] According to one embodiment, the initial login is a PIN-based login.

[0501] According to one embodiment, at least one of the first and second logins is a login based on biometric input or a hardware key.

[0502] According to one embodiment, the patient display device further comprises an auxiliary wireless communication unit, the auxiliary wireless communication unit configured to be disabled to enable wireless communication with the patient-external device.

[0503] According to one embodiment, the patient display device is configured to wirelessly receive the implant control interface from the patient external device as a remote display portal that is displayed on the display.

[0504] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using standard network protocols.

[0505] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a proprietary network protocol.

[0506] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a first network protocol and to wirelessly communicate with the server using a second network protocol.

[0507] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a first frequency band and to wirelessly communicate with the server using a second frequency band.

[0508] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0509] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0510] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0511] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0512] According to one embodiment, the wireless communication unit comprises a first wireless transceiver for communicating with a patient-external device and a second wireless transceiver for communicating with a server.

[0513] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0514] 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.

[0515] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and the external patient device based on authentication.

[0516] According to one embodiment, the patient display device is a wearable external device or a handheld device.

[0517] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0518] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0519] According to one embodiment, the second application is configured to receive data regarding parameters relating to at least one of battery status, temperature, time, and errors.

[0520] According to one embodiment, the patient display device is configured to encrypt user input.

[0521] According to one embodiment, the display is configured to encrypt user input for decoding by the implantable medical device.

[0522] According to one embodiment, the patient display device is configured to decode the control interface received from the patient external device and display the control interface on a display.

[0523] According to one embodiment, at least one of the first and second applications is configured to receive data from the auxiliary external device and present the received data to a user.

[0524] According to one embodiment, at least one of the first and second applications is configured to receive data from an auxiliary external device that includes a scale for measuring the weight of the user.

[0525] According to one embodiment, at least one of the first and second applications is configured to receive data regarding the user's weight from an auxiliary external device comprising a weight scale.

[0526] According to one embodiment, the patient display device is configured to wirelessly transmit data regarding the user's weight to the patient external device, wirelessly transmit instructions derived from the data regarding the user's weight, or wirelessly transmit instructions derived from a combination of the data regarding the user's weight and implant control inputs received from the user.

[0527] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0528] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0529] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0530] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0531] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after a determined amount of food intake. According to one embodiment, the patient display device comprises a first login function and a second login function, the first login function giving the user access to a first application and a combination of the first and second login functions giving the user access to a second application.

[0532] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0533] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0534] According to one embodiment, the second application is configured to receive data regarding parameters related to at least one of the following: battery status, temperature, time, and errors.

[0535] According to one embodiment, the patient display device is configured to encrypt user input.

[0536] According to one embodiment, the display is configured to encrypt user input for decoding by the implantable medical device.

[0537] According to one embodiment, the patient remote external device is configured to act as a router to forward encrypted user input from the patient display device to the implantable medical device without decrypting it.

[0538] According to one embodiment, the patient remote external device is configured to encrypt at least one of the control interface and the control commands.

[0539] 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.

[0540] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0541] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0542] According to one embodiment, the second application is configured to receive data regarding parameters related to at least one of the following: battery status, temperature, time, and errors.

[0543] In accordance with one embodiment of the communication system, patient display device or computer program product of the present invention, the 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 comprising a turbine bump placed within a patient's blood vessel to assist the pumping function of the heart, an steerable prosthetic heart valve, an steerable prosthetic heart valve for increasing blood flow to a coronary artery, an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel from within a patient's body and relocating an injection site, an implantable drug delivery device for injecting potency enhancing drugs into a patient's erectile tissue, a hydraulic, mechanical and / or electrical constriction implant, an steerable volume filling device, an steerable gastric band, an steerable implant for stretching a patient's stomach wall to create a feeling of fullness, an implant configured to sense the frequency with which a patient takes food, an steerable cosmetic implant, an steerable cosmetic implant for adjusting the shape and / or size of a patient's breast area, an implant controlled medical device for emptying the bladder, an implant to prevent urinary incontinence, an implant for preventing anal incontinence, implants to prevent abstinence, implants to control fecal evacuation, 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 constriction of erectile tissue, implants with reservoirs to hold bodily fluids, implants to store and / or empty internal or surgically created reservoirs, implants to communicate with databases outside the body, implants programmable from outside the body, implants programmable from outside the body by wireless signals, implants to treat impotence, implants to control the flow of eggs in the uterine tract, implants to control the flow of sperm in the uterine tract, implants to control the flow of sperm in the vas deferens, implants for preventing the transport of sperm in the vas deferens, implants to treat osteoarthritis, implants to test internal body parameters, implants to control certain treatment parameters from within the body, implants to control internal body parameters from within, implants to control blood pressure, implants to control blood pressure by affecting the dilation of the renal arteries,implants for controlling drug treatment parameters, implants for controlling parameters in the blood, implants for adjusting or replacing bone portions of a patient's body, implants for replacing an organ or part of an organ or its function in a patient, 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 exercise muscles by electrical or mechanical stimulation, implants configured to empty a portion of the intestine on command, an operable implant configured to be inserted into a patient's stomach to reduce the volume of the stomach substantially below the volume of the device, implants configured to empty the bladder from the patient's body by compressing the bladder, implants configured to expel fluids from the patient's body, implants configured to actively lubricate joints with added lubricating fluid, implants configured to remove blood clots and particles from the patient's bloodstream, implants configured to lengthen or straighten a patient's bones to reduce scoliosis, devices for focused stimulation of the brain from several locations, an artificial stomach to 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 vascular ampulla to cause temporary constriction.

[0544] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0545] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0546] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0547] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0548] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0549] According to one embodiment, the patient display device is configured to wirelessly receive from the patient external device an implant control interface to be displayed on the display.

[0550] According to one embodiment, at least two of the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device are configured for wireless communication using a standard network protocol.

[0551] According to one embodiment, at least two of the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device are configured for wireless communication using a proprietary network protocol.

[0552] According to one embodiment, the wireless communication unit of the patient 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 server, or to use the first network protocol for communication with the implantable medical device and the second network protocol for communication with the patient display device.

[0553] According to one embodiment, the wireless communication unit of the patient external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the server, or to use the first frequency band for communication with the implantable medical device and the second frequency band for communication with the patient display device.

[0554] According to one embodiment, the wireless communication unit of the patient display device is configured to use a first network protocol for communication with the external patient device and a second network protocol for communication with the server.

[0555] According to one embodiment, the wireless communication unit of the patient display device is configured to use a first frequency band for communication with the external patient device and a second frequency band for communication with the server.

[0556] According to one embodiment, the wireless communication unit of the server is configured to use a first network protocol for communication with the patient-external device and a second network protocol for communication with the patient display device.

[0557] According to one embodiment, the wireless communication unit of the server is configured to use a first frequency band for communication with the patient-external device and a second frequency band for communication with the patient display device.

[0558] According to one embodiment, the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a Bluetooth transceiver.

[0559] According to one embodiment, the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a UWB transceiver.

[0560] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0561] According to one embodiment, the wireless communication unit of the patient-external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the server, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0562] According to one embodiment, the wireless communication unit of the patient-external device comprises a first wireless transceiver for wireless communication with the implantable medical device and a second wireless transceiver for wireless communication with the patient display device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0563] According to one embodiment, the wireless communication unit of the patient display device comprises a first wireless transceiver for wireless communication with the patient external device and a second wireless transceiver for wireless communication with the server, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0564] According to one embodiment, the second wireless transceiver has one of the following ranges: 2x, 4x, 8x, 20x, 50x, or 100x.

[0565] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0566] 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 configured 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, or configured 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 patient external device is configured to authenticate by the patient display device when the distance between the patient external device and the patient display is less than a predetermined threshold, or configured to authenticate by the patient display device when the distance between the patient external device and the implantable medical device is less than a predetermined threshold, or configured to authenticate by the implantable medical device when the distance between the patient external device and the implantable medical device is less than a predetermined threshold.

[0567] According to one embodiment, the patient display device is configured to allow data transfer between the patient display device and the external patient device based on authentication.

[0568] 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.

[0569] According to one embodiment, the patient external device is configured to enable data transfer between the patient external device and the implantable medical device based on authentication.

[0570] According to one embodiment, the patient display device is a wearable external patient device or a handheld device.

[0571] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0572] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0573] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0574] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0575] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0576] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0577] According to one embodiment, at least one of the Patient Private Key Device or the HCP Private Key Device comprises a hardware key.

[0578] According to one embodiment, the private key device is at least one of a smart card, a key ring device, a watch, an arm or wrist band, a necklace, or any shaped device.

[0579] According to one embodiment of the system, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI are configured for wireless communication using a standard network protocol.

[0580] According to one embodiment, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI are configured for wireless communication using a proprietary network protocol.

[0581] According to one embodiment, the patient EID external device is configured to use a first network protocol to communicate with the implantable medical device and a second network protocol to communicate with the DDI.

[0582] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the DDI.

[0583] 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 private key device.

[0584] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI includes a Bluetooth transceiver.

[0585] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, the patient private key device, and the DDI comprises a UWB transceiver.

[0586] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0587] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the DDI, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0588] According to one embodiment, the patient private key device includes a first wireless transceiver for wirelessly communicating with the HCP EID external device and a second wireless transceiver for wirelessly communicating with the DDI, the second wireless transceiver having a longer range than the first wireless transceiver.

[0589] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0590] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0591] According to one embodiment, the patient EID external device is configured to enable data transfer between the EID external device and the implantable medical device based on authentication of the patient EID external device.

[0592] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0593] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0594] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0595] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

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

[0597] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0598] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0599] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0600] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, and a near field wireless activation communication unit, or direct electrical contact.

[0601] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent for the HCP private key device, an RFID communication and short-range wireless activation communication unit, or direct electrical contact.

[0602] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify said pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated and authorized to execute said commands by the HCP providing its private key.

[0603] According to one embodiment, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device are configured for wireless communication using a standard network protocol.

[0604] According to one embodiment, at least two of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device are configured for wireless communication using a proprietary network protocol.

[0605] 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 patient private key device.

[0606] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the patient private key device.

[0607] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device comprises a Bluetooth transceiver.

[0608] According to one embodiment, at least one of the HCP EID external device, the patient EID external device, the HCP private key device, and the patient private key device comprises a UWB transceiver.

[0609] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0610] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient private key device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0611] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0612] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0613] According to one embodiment, the patient EID external device is configured to enable data transfer between the EID external device and the implantable medical device based on authentication of the patient EID external device.

[0614] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0615] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0616] According to one embodiment, the wireless transceiver, the remote viewing portal, and the remote viewing portal are configured within a patient remote external device.

[0617] According to one embodiment, the system further comprises a patient display device, which may include an assistance application, a display hosting a remote display portal, and a patient display device private key.

[0618] According to one embodiment, the remote display portal can generate commands that are signed with the private key of the patient display device.

[0619] According to one embodiment, the patient remote external device is adapted to accept input from the patient via said patient display device via its remote display portal.

[0620] According to one embodiment, the patient remote external device comprises a graphical user interface disposed on a touch-responsive display exposing buttons representing operational functions of the implanted medical device.

[0621] According to one embodiment, the system is configured to allow the patient to activate the implant at home through a patient remote external device with authorization granted by the patient private key.

[0622] According to one embodiment, the patient private key is configured on at least one of a smart card, a key fob device, a watch, a wrist or wristband, a necklace, and a device of any shape.

[0623] According to one embodiment, the system is configured to allow a patient, when implanted, to operate the implantable medical device at home through a patient remote external device using authorization granted by the patient private key.

[0624] According to one embodiment, the system further comprises a patient EID external device that includes at least one of a read slot or equivalent for a patient private key device, RFID communication, near field wireless activation communication, or direct electrical contact.

[0625] According to one embodiment, the patient EID external device is adapted to synchronize with the patient remote external device.

[0626] According to one embodiment, the patient EID external device further comprises at least one of a patient, a wireless transceiver configured to communicate with the remote external device, and a wired connector for communicating with the patient remote external device.

[0627] According to one embodiment, the patient EID external device is adapted to generate an authorization signed by a patient private key installed in at least one of the patient remote external device and the implantable medical device via the patient EID external device.

[0628] According to one embodiment, the system includes a patient display device that includes an assistance application capable of displaying a remote viewing portal with content delivered from a patient remote external device.

[0629] According to one embodiment, the remote viewing portal and the patient remote external device are adapted to expose buttons for the patient to indicate intent to activate functions of the implantable medical device through the patient remote external device.

[0630] According to one embodiment, the patient display device comprises at least one of a display hosting a remote display portal and a private key for the patient display device.

[0631] According to one embodiment, the Remote Display Portal can generate commands that are signed with a patient private key.

[0632] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices to the system via the HCP EID external device.

[0633] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0634] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0635] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0636] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0637] According to one embodiment, the at least one patient EID external device is adapted to receive information from the implant via a second network protocol.

[0638] According to one embodiment, the system comprises a DDI adapted to receive information from said patient EID external device, the DDI comprising a wireless transceiver configured to communicate with said patient EID external device.

[0639] According to one embodiment, the patient EID external device is adapted to receive commands relayed by the DDI, and is adapted to further send commands to the implanted medical device to change the pre-programmed therapy settings of the implanted medical device, and is further adapted to be activated, authenticated, and authorized to execute said commands by the patient providing a patient private key.

[0640] According to one embodiment, the patient private key device is adapted for the patient to provide the patient private key to the patient EID external device via at least one of a patient private key device read slot or equivalent, RFID communication or other near-field wirelessly activated communication, or direct electrical contact.

[0641] According to one embodiment, the patient EID external device includes at least one of a read slot or equivalent for an HCP private key device, RFID communication, other near-field wirelessly initiated communication, or direct electrical contact.

[0642] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0643] According to one embodiment, the system comprises an implantable medical device that, once implanted, can be adapted to treat a patient or perform a bodily function.

[0644] According to one embodiment, the patient private key is configured on at least one of a smart card, a key fob device, a watch, a bracelet or wristband, a necklace, and a device of any shape.

[0645] According to one embodiment, at least two of the patient EID external device, the IDD, and the patient private key device are configured for wireless communication using standard network protocols.

[0646] According to one embodiment, at least two of the patient EID external device, the IDD, and the patient private key device are configured for wireless communication using a proprietary network protocol.

[0647] 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 patient private key device.

[0648] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the patient private key device.

[0649] According to one embodiment, at least one of the patient EID external device, the patient private key device, and the IDD comprises a Bluetooth transceiver.

[0650] According to one embodiment, at least one of the patient EID external device, the patient private key device, and the IDD comprises a UWB transceiver.

[0651] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0652] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient private key device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0653] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0654] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0655] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0656] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0657] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to be able to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0658] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0659] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0660] According to one embodiment, the system comprises a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0661] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0662] According to one embodiment, at least one patient remote external device includes a patient remote external device private key, and a 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.

[0663] According to one embodiment, the patient EID external device comprises at least one wireless transceiver configured to communicate with the DD1 via a first network protocol.

[0664] According to one embodiment, the system comprises a DDI adapted to receive commands from an HCP EID external device and transmit the received commands to a patient EID external device, the DDI comprising a wireless transceiver configured to communicate with said patient external device.

[0665] According to one embodiment, the patient EID external device is adapted to receive a command from the DDI, the command originating from a healthcare provider (HCP), and the patient EID is adapted to deactivate the patient private key and send the command to the implanted medical device.

[0666] According to one embodiment, the patient EID external device is adapted to receive a command from a DDI, the command originating from a healthcare provider (HCP), the patient EID external device is adapted to receive a command from the HCP via the DDI to deactivate the patient remote external device comprising a patient remote external device private key, and the patient EID external device is further adapted to transmit the command to the implanted medical device.

[0667] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0668] According to one embodiment, at least one of the patient private key and the patient remote external device private key comprises a hardware key.

[0669] According to one embodiment, the private key device is at least one of a smart card, a key ring device, a watch, an arm or wrist band, a necklace, or any shaped device.

[0670] According to one embodiment, at least two of the patient remote external device, the patient EID external device, the patient private key device, and the DDI are configured for wireless communication using standard network protocols.

[0671] According to one embodiment, at least two of the patient remote external device, the patient EID external device, the patient private key device, and the DDI are configured for wireless communication using a proprietary network protocol.

[0672] 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 patient private key device.

[0673] According to one embodiment, the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the patient private key device.

[0674] According to one embodiment, at least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI comprises a Bluetooth transceiver.

[0675] According to one embodiment, at least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI comprises a UWB transceiver.

[0676] According to one embodiment, the standard network protocol is one from the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, and a GSM type protocol.

[0677] According to one embodiment, the patient EID external device comprises a first wireless transceiver for wirelessly communicating with the implantable medical device and a second wireless transceiver for wirelessly communicating with the patient private key device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0678] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0679] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0680] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0681] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0682] According to one embodiment, the system comprises a master private key device configured to enable the issuance of new private key devices, and an HCP or HCP administrator has such master private key device adapted to allow the exchange and pairing of new patient private key devices or HCP private key devices to the system via an HCP EID external device.

[0683] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0684] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0685] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0686] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being connected to a control unit of the medical device to trigger a stomach stretching action after ingestion of a determined amount of food.

[0687] According to one embodiment, the system includes a master private key device that allows for the issuance of new private key devices, and the HCP or HCP administrator, via the HCP EID external device, converts new patient private key devices or HCP private key devices and adapts such master private key devices so that they can be paired to the system.

[0688] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0689] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0690] According to one embodiment, the system further comprises a measurement device or sensor adapted to provide measurements to at least one of the DDI, the patented EID external device, and the patient display device.

[0691] According to one embodiment, the system further comprises a food sensor adapted to measure at least whether the patient is swallowing solids or drinking liquids, said food sensor being configured to be connected to a control unit of the medical device so as to trigger a stomach stretching action after ingestion of a determined amount of food.

[0692] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0693] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, and a near field wireless activation communication unit, or direct electrical contact.

[0694] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent of the HCP private key device, RFID communication, a short-range wireless activated communication unit, or direct electrical contact.

[0695] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify said pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated and authorized to execute said commands by the HCP providing its private key.

[0696] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0697] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.

[0698] According to one embodiment, the HCP 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 HCP private key device.

[0699] According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the HCP private key device.

[0700] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0701] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0702] According to one embodiment, the HCP private key device for configuring the HCP private key comprises at least one of a smart card, a key fob device, a watch, a wrist or wristband, a necklace, and a device of any shape.

[0703] According to one embodiment, the patient private key device comprises a patient private key comprising at least one of a smart card, a key fob device, a watch, a wrist or wristband, a necklace, and a device of any shape.

[0704] According to one embodiment, the patient private key is adapted to initiate, authenticate, and execute said commands provided by the HCP via the HCP EID external device or when actions are performed remotely via the patient EID external device.

[0705] 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, wherein communication between the patient EID external device and the HCP EID external device is via the DDI.

[0706] According to one embodiment, the system includes a master private key device that enables the issuance of new private key devices, and the HCP or HCP administrator has such master private key device adapted to allow new patient private key devices or HCP private key devices to be replaced and paired with the system.

[0707] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0708] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0709] According to one embodiment, the system further comprises a measurement device or sensor adapted to provide measurements to at least one of the DDI, the patented EID external device, and the patient display device.

[0710] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient swallows solid food or drinks liquid, said food sensor being connected to a control unit of the medical device to trigger an action of stretching the stomach after ingestion of a determined amount of food.

[0711] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0712] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, and a short-range wireless activation communication unit, or direct electrical contact.

[0713] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent of an HCP private key device, RFID communication, a short-range wireless activated communication unit, or direct electrical contact.

[0714] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify said pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated and authorized to execute said commands by the HCP providing its private key.

[0715] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0716] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.

[0717] According to one embodiment, the HCP 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 HCP private key device.

[0718] According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the HCP private key device.

[0719] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0720] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0721] According to one embodiment, at least one of the patient private key device or the HCP private key device comprises a hardware key.

[0722] According to one embodiment, the private key device is at least one of a smart card, a key ring device, a watch, an arm or wrist band, a necklace, or any shaped device.

[0723] According to one embodiment, the system includes a master private key device that allows for the issuance of new private key devices, and an HCP or HCP administrator, via an HCP EID external device, adapts such master private key device so that new patient private key devices or HCP private key devices can be exchanged and paired to the system.

[0724] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0725] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0726] According to one embodiment, the system includes a measurement device or sensor adapted to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0727] According to one embodiment, the system comprises a food sensor adapted to measure at least whether the patient swallows solid food or drinks liquid, said food sensor being connected to a control unit of the medical device to trigger an action of stretching the stomach after ingestion of a determined amount of food.

[0728] According to one embodiment, the HCP EID external device further comprises a wireless transceiver configured to communicate with the implantable medical device via a second network protocol.

[0729] According to one embodiment, the HCP private key device is adapted to be provided to at least one HCP external device via at least one of an HCP private key device read slot or equivalent, RFID communication, a short-range wireless activation communication unit, or direct electrical contact.

[0730] According to one embodiment, the HCP EID external device comprises at least one of a read slot or equivalent of an HCP private key device, RFID communication, a short-range wireless activated communication unit, or direct electrical contact.

[0731] According to one embodiment, the HCP EID external device, when implanted, is adapted to receive commands from an HCP dedicated device to modify said pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further adapted to be activated, authenticated and authorized to execute said commands by the HCP providing its private key.

[0732] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0733] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.

[0734] According to one embodiment, the HCP 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 HCP private key device.

[0735] According to one embodiment, the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and a second frequency band for communication with the HCP private key device.

[0736] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0737] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0738] The embodiments, parts of embodiments, methods or parts of methods may be combined in any applicable manner.

[0739] An external system for providing remote instructions to an implantable medical device is also provided. The 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 the checksum. The external system is further configured to form a data packet from the instructions, the digital signature, and the checksum. The implantable medical device further comprises a wireless transmitter configured to wirelessly transmit the data packet to the implantable medical device. The external system may be further configured to encrypt the data packet at the external system. The checksum is configured to verify that the bitstream forming the instructions has not been altered.

[0740] According to one embodiment, the wireless transmitter is part of a wireless transceiver configured in an external system.

[0741] According to one embodiment, the external system comprises a first external device and a second external device, the first external device configured to transmit data packets to the second external device, and the second external device configured to wirelessly transmit the data packets to the implantable medical device without modifying the data packets and / or without fully decoding the data packets.

[0742] The external system may be configured to send at least one instruction to the implantable medical device for altering a control program of the implantable medical device, which may include altering at least one parameter for affecting control of the implantable medical device, which 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.

[0743] 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 the implantable medical device using a second network protocol.

[0744] 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 the implantable medical device using wireless communication.

[0745] 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 wirelessly transmit data packets from the second external device to the implantable medical device using a second network protocol.

[0746] 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 the implantable medical device using a second frequency band.

[0747] 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 wireless technology and wirelessly transmit data packets from the second external device to the implantable medical device using a second wireless technology.

[0748] According to one embodiment, the external system is configured to digitally sign instructions at the external system using a key of the external system, which may be a non-extractable key.

[0749] According to one embodiment, the second external device is configured to perform a proof-of-possession operation including the steps of sending a query based on a public key associated with a private key of the external system from the first external device to the second external device, receiving at the second external device a response based on possession of the private key at the first external device, and verifying that the response based on possession of the private key matches the query based on the public key.

[0750] According to one embodiment, a first external device is configured to form a data packet and digitally sign the instruction using a first private 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 private key, and transmit the data packet from the second external device to the medical implant.

[0751] According to one embodiment, the first external device is configured to digitally sign the instructions and encrypt the data packet using a key located in a key device external to the first external device. The external system may include a key device configured to hold at least one private key that is part of a public-private key pair used for asymmetric encryption.

[0752] According to one embodiment, the key device comprises a wireless transmitter for wirelessly transmitting at least one private key or a signal based on the private key to a first external device, the second external device being configured to digitally sign instructions and / or encrypt data packets using a key located in the key device external to the second external device.

[0753] According to one embodiment, the external system further comprises a second key device configured to hold at least one second private key, and the second key device may comprise a wireless transmitter for wirelessly transmitting the at least one private key or a signal based on the private key to the second external device.

[0754] 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 private key or a signal based on the second private key to the first external device.

[0755] 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.

[0756] The first and / or second external device may be configured to be unlocked by user credentials provided to the first external device, which may consist of a username and password and / or a PIN code.

[0757] In one embodiment, the first external device is configured to verify the user credentials by comparing the user credentials with user credentials stored on the first external device. The user credentials may be stored on the first external device by a manufacturer of the first external device. The user credentials may be stored on the first external device as hardware or software.

[0758] According to one embodiment, the first external device is configured to verify user credentials by communicating with a remote server.

[0759] The external system, in any embodiment herein, may be configured to function without being connected to the Internet and may be configured to communicate with the implantable medical device in a time-independent manner.

[0760] The first and second private keys may be different in any embodiment, although the first and second private keys may include at least one common element, and at least one of the first and second external devices is configured to be unlocked by at least one of the first and second private keys.

[0761] According to one embodiment, the external system includes a central server configured to form a data packet from the instructions, the electronic signature, and the checksum, and further configured to provide the formed data packet to the first external device.

[0762] The central server is accessible to at least one medical professional who can provide input to the central server to form instructions that are transmitted to the implantable medical device.

[0763] The central server may be accessible to at least one patient, who may provide input to the central server to verify the authenticity of the healthcare professional and / or the accuracy of the order. The healthcare professional and / or the patient may electronically sign the order at the central server.

[0764] According to one embodiment, the central server is configured to verify the authenticity of the first and second keys and to digitally sign the instructions using the first and second keys. The second key may be a user key, and the external system may be configured to use the second key to at least one of authorize a communication to be sent to the implantable medical device and authorize a healthcare provider to prepare the instructions for the implantable medical device.

[0765] According to one embodiment, the approval step may be performed by the first or second external device.

[0766] According to one embodiment, a first key is required to generate instructions for the implantable medical device and a second key is required to transmit the generated instructions to the implantable medical device.

[0767] According to one embodiment, at least one of the first and second external devices comprises an input button configured to be used to confirm the presence of a user.

[0768] According to one embodiment, the input button is configured to replace at least one of inputting at least one key into at least one of the first and second external devices and inputting authentication information into at least one of the first and second external devices. The input button may be configured to replace a second key.

[0769] According to one embodiment, the external system is configured to send a data packet to the implantable medical device, the data packet including at least one instruction signed by a first key and a public key including information about which root created the public key.

[0770] According to one embodiment, at least one of the first and second external devices may be configured to enable communication with the implantable medical device based on at least one password provided to at least one of the first and second external devices.

[0771] According to one embodiment, at least one of the first and second external devices is configured to enable communication with the implantable medical device based on two passwords provided to at least one of the first and second external devices.

[0772] According to one embodiment, at least one of the first and second external devices is configured to enable communication with the 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.

[0773] 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 computational challenge from the first or second external device to at least one of the first and second key devices; receiving a response based on the transmitted computational challenge at the first or second external device; and verifying the received response at the first or second external device. The verification query operation may be in the form of a proof-of-possession operation including: receiving a public key of at least one of the first and second key devices, the public key being associated with a private key of the first or second key device; sending a computational 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 possession of the private key at the first or second key device; and verifying that the response based on possession of the private key matches the public key-based query.

[0774] Further provided is an implantable medical device configured to receive remote instructions from an external system. The implantable medical device comprises a wireless receiver configured to receive data packets wirelessly transmitted from the external system, and a computing unit configured to verify the digital signature and the integrity of the instructions using a checksum included in the data packet. The computing unit may be further configured to decrypt the data packet. The computing unit may be configured to verify, using the checksum, that the bitstream constituting the instructions has not been altered.

[0775] The radio receiver may be part of a radio transceiver.

[0776] According to one embodiment, the computing unit comprises a memory unit configured to store the electronic signature, and the computing unit may be configured to verify the electronic signature by comparing the electronic signature with the electronic signature stored in the memory unit.

[0777] According to one embodiment, the implantable medical device comprises a control program configured to control at least one function of the implantable medical device, and the computing device may be configured to modify the control program based on received instructions.

[0778] According to one embodiment, the implantable medical device comprises an internal computing unit configured to execute a control program for controlling functions of the implantable medical device, the control program may include at least one adjustable parameter affecting control of the implantable medical device, and the method of providing remote instructions may include providing instructions for modifying the at least one parameter affecting control of the implantable medical device.

[0779] According to one embodiment, an implantable medical device includes a central unit including a wireless receiver and / or a wireless transceiver, and a security module connected to the central unit, wherein 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 a portion of the decryption and / or signature verification.

[0780] 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.

[0781] According to one embodiment, the wireless receiver or wireless transceiver may be configured to be placed in an off mode in which wireless communications cannot be received by the wireless transceiver, and the rule set may include a rule that specifies that communications from the central unit are accepted by the security module only when the wireless transceiver is placed in the off mode.

[0782] According to one embodiment, the implantable medical device may be configured to decrypt the data packets and / or verify the digital signature using a private key of the implantable medical device. The private key may be a non-extractable key. The private key may be provided to the implantable medical device by the implantable medical device manufacturer or may be stored on the implantable medical device as hardware or software.

[0783] According to one embodiment, the implantable medical device is configured to perform proof-of-possession operations including sending a query from the implantable medical device to an external system based on a public key associated with a private key of the external system, receiving a response at the implantable medical device based on possession of the private key at the external system, and verifying that the response based on possession of the private key matches the query based on the public key.

[0784] The implantable medical device can be configured to communicate with an external system in a time-independent manner.

[0785] According to one embodiment, an implantable medical device is configured to: verify a first electronic signature created using at least one of a first key and a second key; and verify a second electronic signature created using at least one of the first key and the 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 include at least one common element.

[0786] According to one embodiment, the implantable medical device is configured to verify a first electronic signature to authorize communication from an external system to the implantable medical device and to verify a second electronic signature to authorize instructions received in the communication to modify a control program running on the implantable medical device.

[0787] According to one embodiment, the first electronic signature is an electronic signature linked to a user of the implantable medical device and the second electronic signature is an electronic signature linked to a healthcare provider.

[0788] According to one embodiment, only a portion of the private key is required to decrypt the data packet and / or verify the digital signature.

[0789] The implantable medical device trusts the external device with the private key.

[0790] According to one embodiment, the implantable medical device is configured to receive a data packet containing at least one instruction signed by a private key of the external system and a public key containing information about which root created the public key.

[0791] 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.

[0792] According to one embodiment, the implantable medical device is configured to accept communications from an external system based on one patient password and one healthcare provider password provided to the implantable medical device.

[0793] Also provided is a method of providing remote instructions from an external system to an implantable medical device, the method including: deriving, at the external system, a checksum from instructions to be transmitted to the implantable medical device; digitally signing, at the external system, the instructions and the checksum, wherein the instructions, the checksum and the digital signature form a data packet; wirelessly transmitting the data packet to the implantable medical device; verifying the digital signature; and verifying the integrity of the instructions using the checksum.

[0794] According to one embodiment, the method further includes the steps of encrypting the data packet at the external system using a private key of the external system and decrypting the data packet at the implantable medical device using a private key of the implantable medical device.

[0795] According to one embodiment, the step of verifying the electronic signature comprises comparing the electronic signature with an electronic signature stored on the implantable medical device.

[0796] According to one embodiment, the step of wirelessly transmitting the data packet to the implantable medical device comprises transmitting the data packet from the first external device to the second external device using wired communication and wirelessly transmitting the data packet from the second external device to the implantable medical device.

[0797] According to one embodiment, the step of wirelessly transmitting the data packet to the implantable medical device comprises transmitting the data packet from the first external device to a second external device and further wirelessly transmitting the data packet from the second external device to the implantable medical device, wherein the second external device transmits the data packet without modifying and / or fully decoding the data packet.

[0798] According to one embodiment, wirelessly transmitting the data packet to the implantable medical device comprises wirelessly transmitting the data packet from the first external device to the second external device using a first network protocol, and wirelessly transmitting the data packet from the second external device to the implantable medical device using a second network protocol.

[0799] According to one embodiment, the step of wirelessly transmitting the data packet to the implantable medical device comprises the steps of wirelessly transmitting the data packet from the first external device to the second external device using a first frequency band, and wirelessly transmitting the data packet from the second external device to the implantable medical device using a second frequency band.

[0800] According to one embodiment, the step of wirelessly transmitting the data packet to the implantable medical device comprises the steps of wirelessly transmitting the data packet from the first external device to the second external device using a first wireless technology, and wirelessly transmitting the data packet from the second external device to the implantable medical device using a second wireless technology, wherein the first wireless technology has an effective range that is one of the following: 2 times, 4 times, 8 times, 20 times, 50 times, or 100 times that of the first wireless technology.

[0801] 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, and the step of decrypting the data packets at the implantable medical device comprises transferring the data packets from the central unit to the security module and performing at least a portion of the decryption at the security module.

[0802] According to one embodiment, the security module comprises a rule set for accepting communications from the central unit, and the step of forwarding the data packet from the receiving unit of the implant to the security module consists of verifying compliance with the rule set.

[0803] According to one embodiment, the wireless transceiver is configured to be placed in an off mode in which wireless communications cannot be received by the wireless transceiver, and the rule set includes a rule that specifies that communications from the central unit are accepted by the security module only when the wireless transceiver is placed in the off mode.

[0804] According to one embodiment, the step of digitally signing the instruction at the external system comprises digitally signing the instruction at the external system using a private key of the external system.

[0805] According to one embodiment, the step of verifying the electronic signature comprises performing a proof-of-possession operation including the steps of sending a query from the medical device to the external system based on the privately associated public key of the external system, receiving a response at the medical device based on possession of the private key at the external system, and verifying that the response based on possession of the private key matches the query based on the public key.

[0806] According to one embodiment, the step of forming the data packet is performed at a first external device, and the step of digitally signing the instructions includes digitally signing the instructions using a first private key, and the method further includes: transmitting the data packet from the first external device to a second external device; verifying at the second external device that the transmitter is a trusted transmitter; and in response to the verification, digitally signing the data packet using the second private key; transmitting the data packet from the second external device to the medical implant; and verifying at the medical implant the digital signature generated using the first and second private keys. The method can further include verifying the integrity of the instructions using a checksum.

[0807] According to one embodiment, the method according to any one of the previous embodiments is performed without an internet connection and / or independently of time.

[0808] According to one embodiment, the method further comprises the central server being accessed by at least one medical professional, and the medical professional providing input to the central server to form instructions to be transmitted to the implantable medical device.

[0809] 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 trustworthiness of the medical personnel and the accuracy of the instructions.

[0810] According to one embodiment, the healthcare provider may electronically sign the order at a central server and / or the patient may electronically sign the order at a central server.

[0811] According to one embodiment, the method further includes verifying the authenticity of the first and second keys at a central server and digitally signing the instruction using the first and second keys.

[0812] According to one embodiment, the second key is a user key, and the method can include using the second key to at least one of authorizing a communication to be sent to the implantable medical device and authorizing a healthcare provider to prepare instructions for the implantable medical device.

[0813] According to one embodiment, the approval step may be performed by the first or second external device.

[0814] According to one embodiment, a first key is required to generate instructions for the implantable medical device and a second key is required to transmit the generated instructions to the implantable medical device.

[0815] At least one of the first and second external devices may include an input button, and the method may further include pressing the button to confirm the presence of the user. The input button may be located on the second external device.

[0816] According to one embodiment, the method further includes a verification query operation between at least one of the first and second external devices and at least one of the first and second key devices, the verification query operation including the steps of: sending a query including a computational challenge from the first or second external device to at least one of the first and second key devices; receiving a response based on the transmitted computational challenge at the first or second external device; and verifying the received response at the first or second external device. The verification query operation may be in the form of a proof-of-possession operation that includes: receiving a public key for at least one of the first and second key devices, the public key being associated with a private key for the first or second key device; sending a computational 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 possession of the private key at the first or second key device; and verifying that the response based on possession of the private key matches the query based on the public key.

[0817] There is also provided a method of providing remote instructions to an implantable medical device from an external system, the implantable medical device comprising a list of codes and the external system comprising the list of codes, the method including encrypting the instructions at the external system using a code from a location on the list of codes, wirelessly transmitting the encrypted instructions to the implantable medical device, and decrypting the instructions at the implantable medical device using the code from a location on the list of codes.

[0818] According to one embodiment, the method further includes wirelessly transmitting location information from the external device to the implantable medical device and using the information to select a code from a code list at the implantable medical device.

[0819] According to one embodiment, in the external system, the step of encrypting the instruction using a code from a position on the list of codes includes selecting a code at a current position on the list of codes, and the method further includes the step of updating the current position to the new current position after using the code.

[0820] According to one embodiment, in the implantable medical device, the step of decoding instructions using a code from a position on the list of codes includes selecting a code at a current position on the list of codes, and the method further includes the step of updating the current position to a new current position after using the code.

[0821] According to one embodiment, the current location comprises a number and the step of updating the current location comprises updating the number to a consecutive number.

[0822] According to one embodiment, the step of wirelessly transmitting the encrypted instructions to the implantable medical device includes transmitting the encrypted instructions from a first external device to a second external device and further wirelessly transmitting the encrypted instructions from the second external device to the implantable medical device, wherein the second external device transmits the encrypted instructions without modifying the encrypted instructions and / or without fully decrypting the instructions.

[0823] In accordance with one embodiment of the present inventive concept, there is provided an implantable medical device for draining urine from a patient's bladder, the implantable medical device comprising: an implantable power member having a bladder surface contact portion, the implantable power member adapted to apply a force to a selected portion outside the bladder to drain urine from the bladder; a support structure for the implantable power member, the support structure adapted to support against at least one of bone or soft tissue; and optionally a controller, the controller comprising an energy source and configured to actuate the implantable power member, wherein the force of the implantable power member applied to the bladder when draining urine from the bladder is exerted at least in part against the support, and the support structure comprising fixed attachment means adapted to support against the bone or soft tissue.

[0824] In some embodiments, the implantable force member comprises a force transmission structure for transmitting a force applied to the bladder by the support structure.

[0825] In some embodiments, the fixed attachment means of the support structure is adapted to support against a bone.

[0826] In some embodiments, the bone is selected from the pelvic bone, the pubic bone, or the sacrum.

[0827] In some embodiments, the means for fixed attachment to the bone comprises a plate adapted to the bone and means for fixing the plate to the bone.

[0828] In some embodiments, the plate comprises at least one opening through which the fastening means is passed.

[0829] In some embodiments, the plate comprises a lip-like structure for positioning on the bone.

[0830] In some embodiments, the plate is configured for fixed frontal attachment to the bone.

[0831] In some embodiments, the plate is configured for dorsal fixation to the bone.

[0832] In some embodiments, the plate is further configured for fixed attachment to the bone in a coccygeal direction.

[0833] In some embodiments, the plate is configured for fixed attachment with fixation means that penetrate completely through the bone.

[0834] In some embodiments, the plate has a curvature configured to engage the bone.

[0835] In some embodiments, the curvature comprises a hump or groove.

[0836] In some embodiments, the means for securing the plate to the bone comprises at least one of a screw, a pin, an anchor, and a cement.

[0837] In some embodiments, the plate-to-bone fixation means (848) comprises at least one of a screw, a pin, and an anchor, and each fixation means is attached to the plate at an attachment angle α between 15 degrees and 165 degrees.

[0838] In some embodiments, the mounting angle α is between 30 degrees and 150 degrees.

[0839] In some embodiments, the mounting angle α is between 45 degrees and 135 degrees.

[0840] In some embodiments, the mounting angle α is between 60 degrees and 120 degrees.

[0841] In some embodiments, each fixation means of the plate to the bone has a different attachment angle α.

[0842] In some embodiments, the fixed attachment means of the support structure is adapted to support against soft tissue.

[0843] In some embodiments, the soft tissue is selected from the peritoneum, the abdominal or pelvic wall, or the urinary bladder itself.

[0844] In some embodiments, the implantable medical device comprises a further support structure for the implantable power member, said further support structure having fixed attachment means adapted to support against bone.

[0845] In some embodiments, the support structure comprises a fixed attachment means adapted to support against soft tissue and is attached by a force distribution structure to a further support structure comprising a fixed attachment means adapted to support against bone.

[0846] In some embodiments, the force transmission structure is hydraulically operated to provide compression or release of the bladder.

[0847] In some embodiments, the force carrying structure comprises a hydraulically movable arm.

[0848] In some embodiments, the support structure comprises a surgical mesh.

[0849] In some embodiments, the surgical mesh is made of non-absorbable and / or absorbable materials.

[0850] In some embodiments, the non-absorbable material comprises at least one of polypropylene (PP), expanded polytetrafluoroethylene (ePTFE), and polyester (PET).

[0851] In some embodiments, the surgical mesh comprises a composite prosthesis.

[0852] In some embodiments, the surgical mesh is made of a biological material.

[0853] In some embodiments, the biological material comprises bovine or porcine tissue.

[0854] In some embodiments, the surgical mesh is made from a nanotechnology material.

[0855] In some embodiments, the force distribution structure maintains the support structure at an appropriate distance from the bladder to support the force transmission structure for exerting a force outside a selected portion of the bladder.

[0856] In some embodiments, the second support structure comprises a mechanical wire or tube.

[0857] In accordance with one embodiment of the inventive concept, there is provided a method for attaching an implantable medical device to soft tissue, comprising the steps of: making an incision in a patient's abdomen to access the soft tissue; dissecting a portion of the soft tissue; inserting an implantable medical device into the patient's abdomen; optionally attaching a control device of the implantable medical device to the partially dissected soft tissue; attaching an attachment means of a support structure of the implantable medical device to the partially dissected soft tissue; positioning an implantable power member of the implantable medical device so that it can apply force to a selected portion outside the bladder to drain urine from the bladder; and closing the incision in the abdominal soft tissue and skin.

[0858] In some embodiments, the method includes attaching an implantable control device of the medical device to the soft tissue from which a portion has been dissected, and attaching an attachment means of a support structure of the implantable medical device to the soft tissue surrounding the control device such that the control device further supports the implantable power member.

[0859] In some embodiments, the attachment means comprises a surgical mesh, and the step of attaching the attachment means of the support structure of the implantable medical device to the soft tissue from which the portion has been dissected comprises securing the surgical mesh to the soft tissue.

[0860] In some embodiments, the abdominal soft tissue incision is closed with sutures, staples, or surgical adhesive.

[0861] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be positioned through an opening in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane, the connecting portion configured to connect the first portion to the second portion; and an airtight seal arrangement configured to surround the connecting portion to prevent fluids from the patient from entering the connecting portion, wherein the first, second, and third planes are parallel to one another, and the third cross-sectional area is smaller than the first and second cross-sectional areas, so as to prevent the first and second portions from moving through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes, and the connecting portion comprises a flexible structure that allows the connecting portion to flex.

[0862] In some embodiments, the flexible structure is configured to allow the connecting portion to flex in multiple directions.

[0863] In some embodiments, the flexible structure is configured to allow the linking portion to flex in any direction.

[0864] In some embodiments, the flexible structure comprises a bellows.

[0865] In some embodiments, the bellows is a metal bellows.

[0866] In some embodiments, the metal bellows is welded.

[0867] In some embodiments, the bellows is a titanium bellows.

[0868] In some embodiments, the bellows forms part of a hermetic seal arrangement.

[0869] In some embodiments, the flexible structure comprises an elevating portion that allows said deflection of the connecting portion.

[0870] In some embodiments, the lifting portion is configured to allow the linking portion to be compressed and / or expanded.

[0871] In some embodiments, the flexible structure has a substantially cylindrical shape.

[0872] In some embodiments, the flexible structure is configured to seal against the first portion and / or the second portion.

[0873] In some embodiments, the connecting portion and the second portion are hermetically sealed from the first portion.

[0874] In some embodiments, the hermetic seal arrangement surrounds the connecting portion and the second portion so as to hermetically seal the connecting portion and the second portion from the first portion.

[0875] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0876] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0877] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0878] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0879] In some embodiments, the solid state battery is a thionyl chloride battery.

[0880] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0881] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0882] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0883] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0884] In some embodiments, the first control device is connected in the first portion to a first wireless communication receiver for receiving wireless communication from an external device; The first controller is coupled to the first wireless communication transmitter in the first portion for transmitting wireless communications to the second wireless communication receiver in the second portion.

[0885] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0886] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0887] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0888] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0889] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0890] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0891] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0892] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0893] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0894] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0895] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0896] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0897] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0898] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0899] In some embodiments, the first end and the second end each comprise an elliptical point.

[0900] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0901] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0902] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0903] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0904] In some embodiments, the implantable energized medical device further comprises a gear arrangement and an electric motor, the gear arrangement configured to slow down and increase the force of the motion generated by the electric motor.

[0905] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0906] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0907] In some embodiments, the gear arrangement comprises a gear system.

[0908] In some embodiments, the second portion comprises a magnetic coupling for transmitting mechanical work from the electric motor through one of a barrier separating a first chamber of the second portion from a second chamber of the second portion, and a housing surrounding at least the second portion.

[0909] In some embodiments, the second portion comprises at least one hydraulic pump.

[0910] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0911] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through an aperture in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane. and a connecting portion configured to connect the first portion to the second portion, the connecting portion having a third cross-sectional area in a direction perpendicular to the first, second, and third planes, the third cross-sectional area being smaller than the first and second cross-sectional areas and configured to prevent the first and second portions from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes, the connecting portion and the second portion being configured to form a unit having a central axis extending from a first end of the unit to a second end of the unit, the first end being proximal to the first portion and the second end being distal to the first portion, and the physical footprint of the unit perpendicular to the central axis decreasing continuously or in steps from the first end to the second end of the unit.

[0912] In some embodiments, the physical footprint comprises a cross-sectional area perpendicular to a central axis.

[0913] In some embodiments, the linking portion and the second portion are either configured to reversibly link to each other to form the unit, or configured to irreversibly link to each other to form the unit, or configured as a single body to form the unit.

[0914] In some embodiments, the unit comprises a corner that forms a bend in the unit.

[0915] In some embodiments the bend is between 15° and 165°, such as between 30° and 150°, such as between 45° and 135°, for example substantially 90°.

[0916] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by the external wireless energy transmitter and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion, and the second portion comprises a second wireless energy receiver configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter.

[0917] In some embodiments, the first portion comprises a first energy storage unit connected to a first wireless energy receiver.

[0918] In some embodiments, the second portion comprises a second energy storage unit connected to a second wireless energy receiver.

[0919] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0920] In some embodiments, the solid state battery is a thionyl chloride battery.

[0921] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0922] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0923] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0924] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0925] In some embodiments, the first control device is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first control device is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0926] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0927] In some embodiments, the first wireless energy receiver comprises a first coil and the wireless energy transmitter comprises a second coil.

[0928] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and to wirelessly transmit energy to a second wireless receiver in the second portion.

[0929] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0930] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0931] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0932] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, wherein the first portion of the housing is made from titanium and the second portion of the housing is made from a ceramic material.

[0933] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0934] In some embodiments, the first portion is removably coupled to at least one of the second portion and the coupling portion.

[0935] In some embodiments, the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion so as to prevent the flange from moving through the hole in the tissue portion, such that the second portion and the connecting portion can be held in place by the patient's tissue portion even when the first portion is disconnected from the connecting portion.

[0936] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0937] In some embodiments, the coupling interface between the coupling portion and the first portion is eccentric relative to the first portion.

[0938] In some embodiments, the second portion has a first end and a second end opposite the first end, and the second portion has a length between the first end and the second end.

[0939] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0940] In some embodiments, the first end and the second end each comprise an elliptical point.

[0941] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0942] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0943] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0944] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0945] In some embodiments, the implantable energized medical device further comprises a gear arrangement and an electric motor, the gear arrangement configured to slow down and increase the force of the motion generated by the electric motor.

[0946] In some embodiments, the gear arrangement is configured to transfer a high velocity force to a lower velocity, stronger force.

[0947] In some embodiments, the gear arrangement is configured to transfer rotational force to linear force.

[0948] In some embodiments, the gear arrangement comprises a gear system.

[0949] In some embodiments, the second portion comprises a magnetic coupling for transmitting mechanical work from the electric motor through one of a barrier separating a first chamber of the second portion from a second chamber of the second portion, and a housing surrounding at least the second portion.

[0950] In some embodiments, the second portion comprises at least one hydraulic pump.

[0951] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0952] In accordance with one embodiment of the present inventive concept, there is provided an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through an aperture in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion. and a connecting portion connected to the first portion and the second portion, wherein the first, second, and third planes are parallel to one another, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first portion and the second portion are prevented from moving through an opening in the tissue portion in a direction perpendicular to the first, second, and third planes; the connecting portion is configured to extend between the first portion and the second portion along a central extension axis, and the second portion is configured to extend in a longitudinal direction diverging from the central extension axis, the connecting portion having a cross-sectional area that decreases in a direction from the first portion to the second portion along the central extension axis, a maximum cross-sectional area of ​​the second portion in the longitudinal direction that is smaller than a minimum cross-sectional area of ​​the connecting portion in the direction from the first portion to the second portion along the central extension axis; and the second portion further having a cross-sectional area that decreases in the longitudinal direction from a first end of the second portion proximal to the connecting portion to a second end of the second portion distal to the connecting portion.

[0953] In accordance with one embodiment of the present inventive concept, there is provided an implantable energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion. a second portion having a surface; a connecting portion configured to be positioned through an opening in the tissue portion extending between a first side and a second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane, the connecting portion configured to connect the first portion to the second portion; and an electric motor, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, so as to prevent the first portion and the second portion from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane, and at least a portion of the electric motor is disposed within the connecting portion.

[0954] In some embodiments, the electric motor is disposed within the linkage portion within an imaginary boundary defined by a first surface of the first portion extending through the linkage portion.

[0955] In some embodiments, the electric motor is disposed within the coupling portion within an imaginary boundary defined by a second surface of the second portion extending through the coupling portion. ...

Claims

1. 1. An implantable medical device for draining urine from a patient's bladder (U), comprising: an implantable powered member (800) having a bladder surface contact portion (820) and adapted to apply a force to a selected portion outside the bladder to expel urine from the bladder; a support structure (840, 850) for said implantable powered member (800) adapted to support against at least one of bone or soft tissue; a control device (900) optionally including an energy source and configured to operate said implantable powered member; Equipped with a force applied to the bladder by the implantable powered member (800) when emptying urine from the bladder is exerted at least in part against the support structure (840, 850); The implantable medical device is characterized in that the support structure (840, 850) comprises a fixed attachment means (846, 848, 922) adapted to support against the bone or soft tissue.

2. 10. The implantable medical device of claim 1, wherein the implantable powered member (800) comprises a force transmission structure (842, 852) for transmitting forces applied to the bladder by the support structure (840, 850, 920).

3. 10. The implantable medical device of claim 1, wherein the fixed attachment means (846, 848) of the support structure (840) is adapted to support against the bone.

4. The implantable medical device of claim 3 , wherein the bone is selected from a pelvic bone, a pubic bone, or a sacrum.

5. 4. The implantable medical device of claim 3, wherein said means for fixed attachment to the bone comprises a plate (846) adapted to the bone and means for fixing the plate to the bone (848).

6. 6. The implantable medical device of claim 5, wherein the plate comprises at least one opening (847) pierced by a fastening means (848).

7. The implantable medical device of claim 5 , wherein the plate comprises a lip-like structure (849) for positioning over the bone.

8. 6. The implantable medical device of claim 5, wherein the plate is configured for fixed attachment to the bone from a frontal direction (870).

9. 6. The implantable medical device of claim 5, wherein the plate is configured for fixed attachment from a dorsal direction (872) to the bone.

10. 9. The implantable medical device of claim 8, wherein the plate is further configured for fixed attachment to the bone from a caudal direction (874).

11. 6. The implantable medical device of claim 5, wherein the plate is configured for fixed attachment with fixation means (848') that penetrate completely through the bone.

12. The implantable medical device of claim 5 , wherein the plate has a curvature configured to engage the bone.

13. The implantable medical device of claim 12 , wherein the curvature comprises a hump (880) or a groove (882).

14. The implantable medical device of claim 5, wherein the means for fixing (848) of the plate to the bone comprises at least one of a screw, a pin, an anchor, and a cement.

15. 6. The implantable medical device of claim 5, wherein the fixing means (848) of the plate to the bone comprises at least one of a screw, a pin, and an anchor, each fixing means being attached to the plate at an attachment angle α between 15 degrees and 165 degrees.

16. The implantable medical device of claim 15, wherein the attachment angle α is between 30 degrees and 150 degrees.

17. 17. The implantable medical device of claim 16, wherein the attachment angle α is between 45 degrees and 135 degrees.

18. 18. The implantable medical device of claim 17, wherein the attachment angle α is between 60 degrees and 120 degrees.

19. 16. The implantable medical device of claim 15, wherein each fixation means (848) of the plate to the bone has a different attachment angle α.

20. 10. The implantable medical device of claim 1, wherein the fixed attachment means (922) of the support structure (850) is adapted to support against soft tissue.

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