IMPLANTABLE ELECTRICALLY ACTIVATED MEDICAL DEVICES, ASSOCIATED METHODS AND KITS - Patent application

Abstract

The present invention provides an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface of the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface of the second side of the tissue portion; and a connecting portion configured to be positioned through a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and having a third surface configured to engage a first tissue surface on the first side of the tissue portion and 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, and the third cross-sectional area being smaller than the first cross-sectional area and the second cross-sectional area, preventing the first portion, the second portion, and the connecting portion from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

Description

[Technical Field]

[0001] The present invention relates to medical implants, and more particularly to medical implants configured to be held in place by the body tissue of a patient. [Background technology]

[0002] Medical devices designed to be implanted within a patient's body are typically powered by electrical power. Such medical devices include electrical and mechanical stimulators, motors, pumps, and the like, which are designed to assist or stimulate various bodily functions. Such implantable medical devices can be powered by either a similarly implanted battery or by an external energy source that can provide any required amount of power, intermittently or continuously, without the need for repeated surgical procedures.

[0003] An implantable energy receiver or other implantable device necessary for the operation of an implantable medical device must be placed within the patient's body in some safe and convenient manner. To minimize the distance between the external device, such as an energy transmitter, and the implanted device, the implanted device must often be placed close to the patient's skin. In practice, this means subcutaneous placement of the implanted device.

[0004] It is also often important that the implanted device remain in a relatively fixed position, for example, to ensure accurate energy delivery.

[0005] There is a need for improved energized medical devices for implantation in patients. Summary of the Invention

[0006] SUMMARY OF THE INVENTION The object of the inventive concept is to mitigate, alleviate or eliminate one or more of the above-identified deficiencies and drawbacks in the art singly or in any combination.

[0007] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by 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 of the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface of the second side of the tissue portion. and a connecting portion configured to be positioned through an opening in the tissue portion extending between the first side and the second side, the connecting portion having a third cross-sectional area in a third plane and a fourth cross-sectional area in a fourth plane, the connecting portion comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter the first plane, the second plane, the third plane, and the fourth plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area and the fourth cross-sectional area, 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 plane, the second plane, and the third plane, and the first portion is removably connected to at least one of the connecting portion and the second portion.

[0008] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0009] In some embodiments, the third cross-sectional area is equal to or greater than the first cross-sectional area.

[0010] In some embodiments, the connecting portion includes a flange defining a fourth cross-sectional area, the flange being configured to be prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0011] In some embodiments, the flanges project in directions parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0012] In some embodiments, the flange comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0013] In some embodiments, the connecting portion includes at least one protruding element defining a fourth cross-sectional area and configured to prevent the at least one protruding element from migrating through a hole 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 disconnected from the connecting portion.

[0014] In some embodiments, the at least one protruding element protrudes in a direction parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0015] In some embodiments, 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.

[0016] In some embodiments, the connecting portion comprises at least two protruding elements that define a fourth cross-sectional area.

[0017] In some embodiments, the at least two protruding elements are symmetrically arranged about the central axis of the connecting portion.

[0018] In some embodiments, the at least two protruding elements are asymmetrically positioned about the central axis of the connecting portion.

[0019] In some embodiments, at least one of the first, second, and third surfaces includes 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 a tissue portion.

[0020] In some embodiments, the connecting portion comprises a hollow portion.

[0021] In some embodiments, the hollow portion provides a passageway between the first portion and the second portion.

[0022] In some embodiments, the first portion is removably connected to the connecting portion by at least one of a mechanical connection and a magnetic connection.

[0023] In some embodiments, the first portion is removably connected to the connecting portion by at least one of a thread and corresponding groove, a screw, a self-locking element, a twist-lock coupling, and a spring-loaded locking mechanism.

[0024] In some embodiments, the at least one protruding element has a height in a direction perpendicular to the fourth plane that is smaller than a height of the first portion in said direction.

[0025] In some embodiments, 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.

[0026] In some embodiments, 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.

[0027] In some embodiments, at least one protruding 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.

[0028] In some embodiments, at least one protruding element has a diameter in the fourth plane that 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.

[0029] In some embodiments, at least one protruding element has a cross-sectional area in the fourth plane that 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.

[0030] In some embodiments, the at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than half the height of the connecting portion in said direction.

[0031] In some embodiments, at least one protruding element has a height in said direction perpendicular to the fourth plane that is less than one-quarter of said height of the connecting portion in said direction.

[0032] In some embodiments, at least one protruding 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.

[0033] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by 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 first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion. a second surface having a second cross-sectional area in a third plane and configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be disposed through an opening in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another, the third cross-sectional area is smaller than the first and second cross-sectional areas, the first portion and the second portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes, and the connecting interface between the connecting portion and the second portion is eccentric with respect to the second portion.

[0034] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion in a first direction but not in a second direction perpendicular to the first direction.

[0035] In some embodiments, the coupling interface between the coupling portion and the second portion is off-center relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0036] In some embodiments, the first direction and the second direction are parallel to a second plane.

[0037] 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.

[0038] In some embodiments, the first end and the second end are spaced apart in a direction parallel to the second plane.

[0039] In some embodiments, the second portion is curved along its length.

[0040] In some embodiments, the second portion is curved in the first direction, and the second direction is perpendicular to the first direction.

[0041] In some embodiments, the first end and the second end each comprise an elliptical point.

[0042] In some embodiments, the first and second ends each include a hemispherical end cap.

[0043] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0044] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0045] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0046] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0047] In some embodiments, the second portion has a proximal region, an intermediate region, and a distal region.

[0048] In some embodiments, the proximal region extends from the first end to the interface between the connecting portion and the second portion, the intermediate region is defined by the connecting interface between the connecting portion and the second portion, and the distal region extends from the interface between the connecting portion and the second portion to the second end.

[0049] In some embodiments, the proximal region is shorter than the distal region with respect to the length of the second portion.

[0050] In some embodiments, the proximal region and the intermediate region together are shorter than the distal region with respect to the length of the second portion.

[0051] In some embodiments, the proximal region and the distal region comprise a second surface configured to engage a second surface of a second side of the tissue portion.

[0052] In some embodiments, the second portion is perpendicular to each other and has a length x and a width y along respective lengthwise and widthwise directions that are substantially parallel to a second plane, and the connecting interface between the connecting portion and the second portion is included within a region extending from x > 0 to x < x / 2, and / or from y > 0 to y < y / 2, where x and y and 0 are respective endpoints of the second portion along the lengthwise and widthwise directions.

[0053] In some embodiments, the second portion is tapered from the first end towards the second end.

[0054] In some embodiments, the second portion is tapered from each of the first end and the second end towards an intermediate region of the second portion.

[0055] In some embodiments, the first portion has a maximum dimension in the range of 10 - 40 mm, such as in the range of 10 - 30 mm, such as in the range of 15 - 25 mm.

[0056] In some embodiments, the first portion has a diameter in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0057] In some embodiments, the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, for example in the range of 5 to 10 mm.

[0058] In some embodiments, the second portion has a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 35 to 60 mm.

[0059] In some embodiments, the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flattened disk shape.

[0060] In some embodiments, the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane.

[0061] In some embodiments, the distal region is configured to face downward in a standing patient.

[0062] In some embodiments, the first portion comprises a proximal region extending from the first end to an interface between the connecting portion and the first portion, an intermediate region defined by the connecting interface between the connecting portion and the first portion, and a distal region extending from the interface between the connecting portion and the first portion to a second end of the first portion.

[0063] In some embodiments, the first portion has a first height and the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, and the first height being less than the second height.

[0064] In some embodiments, the first height is less than 2 / 3 of the second height, such as less than 1 / 2 of the second height, such as less than 1 / 3 of the second height.

[0065] In some embodiments, the second end of the second portion comprises a connection portion for connecting to an implant located caudally from the location of the implantable energized medical device within the patient.

[0066] In some embodiments, the first end of the second portion comprises a connection for connecting to an implant located cranially from the location of the implantable energized medical device within the patient.

[0067] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through a hole in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion comprising a third cross-sectional area configured to face a third tissue surface on the second side of the tissue portion. a third cross-sectional area in the plane of the first portion and configured to couple the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another, and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, such that the first portion and the second portion are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the first cross-sectional area has a first cross-sectional distance and a second cross-sectional distance; The cross-sectional distance and the second cross-sectional distance are perpendicular to each other, the first cross-sectional distance is longer than the second cross-sectional distance, the second cross-sectional area has a first cross-sectional distance and a second cross-sectional distance, the first cross-sectional distance and the second cross-sectional distance are perpendicular to each other, the first cross-sectional distance is longer than the second cross-sectional distance, and the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are rotationally displaced relative to each other by an angle greater than 45° to facilitate insertion of the second portion through the hole in the tissue portion.

[0068] In some embodiments, the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are rotationally displaced relative to one another by an angle greater than 60° to facilitate insertion of the second portion through a hole in the tissue portion.

[0069] In some embodiments, the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are substantially perpendicular to one another to facilitate insertion of the second portion through a hole in the tissue portion.

[0070] In some embodiments, the first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area are rotationally displaced relative to one another by an angle greater than 45° and less than 135°.

[0071] In some embodiments, the cross-sectional area of ​​the first portion is elongated.

[0072] In some embodiments, the cross-sectional area of ​​the second portion is elongated.

[0073] In some embodiments, the connecting portion is eccentrically connected to the second portion.

[0074] In some embodiments, a first cross-sectional distance of the second portion is divided into first, second and third equal length portions, and the connecting portion is connected to the second portion along the first length portion of the first cross-sectional distance.

[0075] In some embodiments, the first cross-sectional area of ​​the first portion is elongated.

[0076] In some embodiments, the second cross-sectional area of ​​the second portion is elongated.

[0077] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0078] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0079] In some embodiments, the second portion comprises a second wireless energy receiver.

[0080] In some embodiments, the first portion comprises a first energy storage unit.

[0081] In some embodiments, the second portion comprises a second energy storage unit.

[0082] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0083] In some embodiments, the solid state battery is a thionyl chloride battery.

[0084] 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.

[0085] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0086] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0087] 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.

[0088] 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.

[0089] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0090] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0091] 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.

[0092] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0093] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least a 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.

[0094] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0095] 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.

[0096] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0097] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a tissue portion extending between the first side and the second side of the tissue portion. and 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 configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area to prevent the first portion and the second portion from moving through the hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane. The first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an 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.

[0098] In some embodiments, the implantable energized medical device further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0099] In some embodiments, the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.

[0100] In some embodiments, the sensor is configured to sense at least one of a temperature of the implantable energized medical device or body-engaging portion, a parameter related to power consumption of the implantable energized medical device or body-engaging 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.

[0101] In some embodiments, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0102] In some embodiments, the sensor is a sensor 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.

[0103] In some embodiments, 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.

[0104] In some embodiments, the sensor configured to sense pH is configured to sense acidity in the stomach.

[0105] In some embodiments, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0106] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0107] In some embodiments, the second portion comprises at least one electric motor.

[0108] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion generated by the electric motor.

[0109] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0110] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0111] In some embodiments, the transmission comprises a gear system.

[0112] 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.

[0113] In some embodiments, the second portion comprises at least one hydraulic pump.

[0114] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0115] In some embodiments, the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor being configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0116] In some embodiments, at least one of the first and second portions comprises a sensation generator configured to generate a sensation detectable by the patient's senses.

[0117] In some embodiments, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0118] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit a force from the second portion to the implant engaging portion.

[0119] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted implant engaging portion.

[0120] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0121] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0122] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0123] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0124] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0125] In some embodiments, 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, wherein the first and second hydraulically actuatable implant elements are adjustable independently of one another.

[0126] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0127] In some embodiments, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0128] In some embodiments, the implantable energized 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.

[0129] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0130] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0131] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through an opening in the tissue portion extending between the first side and the second side, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, such that the first portion and the second portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; and at least one of the first portion and the second portion comprises at least one coil embedded in a ceramic material, the at least one coil configured for at least one of receiving wirelessly transmitted energy, wirelessly transmitting energy, receiving wireless communications, and transmitting wireless communications.

[0132] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0133] In some embodiments, the first portion comprises a first wireless communication receiver.

[0134] In some embodiments, the first portion comprises a coil embedded in a ceramic material, hereinafter referred to as the first coil.

[0135] In some embodiments, the first wireless energy receiver comprises a first coil.

[0136] In some embodiments, the first wireless communication receiver comprises a first coil.

[0137] In some embodiments, the first portion comprises a distal end and a proximal end relative to the connecting portion along a direction perpendicular to the first plane.

[0138] In some embodiments, the first coil is disposed at a distal end of the first portion.

[0139] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0140] In some embodiments, the first portion comprises a first wireless communication transmitter.

[0141] In some embodiments, the first portion comprises a coil (hereinafter referred to as the second coil) embedded in a ceramic material.

[0142] In some embodiments, the internal wireless energy transmitter comprises a second coil.

[0143] In some embodiments, the first wireless communication transmitter comprises the second coil.

[0144] In some embodiments, the second coil is disposed at the proximal end of the first portion.

[0145] In some embodiments, the first wireless energy receiver and the internal wireless energy transmitter are comprised of a single coil embedded in a ceramic material.

[0146] In some embodiments, the first wireless communication receiver and the first wireless communication transmitter comprise a single coil embedded in a ceramic material.

[0147] In some embodiments, the first wireless energy receiver, the internal wireless energy transmitter, the first wireless communication receiver, and the internal wireless communication transmitter are comprised of a single coil embedded in a ceramic material.

[0148] In some embodiments, the second portion comprises a second wireless energy receiver.

[0149] In some embodiments, the second portion includes a coil (hereinafter referred to as the third coil) embedded in a ceramic material, and the second wireless energy receiver includes the third coil.

[0150] In some embodiments, the second portion comprises a distal end and a proximal end relative to the connecting portion along a direction perpendicular to the first plane.

[0151] In some embodiments, the third coil is disposed at the proximal end of the second portion.

[0152] In some embodiments, the first portion comprises a first energy storage unit.

[0153] In some embodiments, the second portion comprises a second energy storage unit.

[0154] 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.

[0155] In some embodiments, the first energy storage unit is configured to store less energy than the second energy storage unit and is configured to charge faster than the second energy storage unit.

[0156] In some embodiments, the first energy storage unit has a lower energy density than the second energy storage unit.

[0157] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least a 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.

[0158] In some embodiments, the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0159] 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.

[0160] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0161] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0162] In some embodiments, the connecting portion further includes a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second, and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0163] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0164] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0165] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0166] In accordance with one embodiment of the present inventive concept, there is provided an implantable device for exerting a force on a body part of a patient, the implantable device comprising an implantable energized medical device having an implantable element configured to exert a force on a body part of a patient.

[0167] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constrictor.

[0168] In some embodiments, the implantable hydraulic constriction device is configured to constrict a luminal organ of a patient.

[0169] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the patient's intestine.

[0170] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the colon or rectum of a patient.

[0171] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine in the region of the patient's stoma.

[0172] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel in a patient.

[0173] In some embodiments, the implantable hydraulic constriction device for constricting a patient's blood vessels is configured to constrict venous blood flow leading from the erectile tissue to facilitate anchoring of the erectile tissue.

[0174] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel in a patient.

[0175] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively emptying the patient's bladder.

[0176] In some embodiments, 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.

[0177] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively stretching the patient's stomach wall to induce a feeling of satiety.

[0178] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a method of implanting an implantable, energized medical device, the method comprising: positioning a second portion of the implantable, energized medical device between the peritoneum and a layer of abdominal wall musculature; 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 being configured to be connected by a connecting portion extending through at least one layer of abdominal wall musculature; and positioning a body-engaging portion of the implantable, energized medical device in association with a tissue or organ of the patient affected by the implantable, energized medical device, and a transmission member configured to transmit at least one of energy and force from the second portion to the body-engaging portion, the transmission member being positioned at least partially between the peritoneum and the layer of abdominal wall musculature, such that at least one-third of the length of the transmission member is positioned outside the peritoneum.

[0179] In some embodiments, the transmission member is configured to transmit a mechanical force from the second portion to the body engaging portion.

[0180] In some embodiments, the transmission member is configured to transmit hydraulic force from the second portion to the body engaging portion.

[0181] In some embodiments, the transmission member is configured to transmit electrical energy force from the second portion to the body engaging portion.

[0182] In some embodiments, the transmission member is configured to transfer data between the second portion and the body engaging portion.

[0183] In some embodiments, 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.

[0184] In some embodiments, 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.

[0185] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member entirely outside of the patient's peritoneum.

[0186] In some embodiments, the step of positioning the transfer member includes positioning the transfer member to extend from the second portion outside the peritoneum to a region between the patient's rib cage and the peritoneum.

[0187] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member such that the transfer member extends from the second portion to a region between the patient's stomach and thoracic diaphragm.

[0188] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member such that the transfer member extends from the second portion to the patient's stomach.

[0189] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member such that the transfer member extends from the second portion to the patient's esophagus.

[0190] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the retroperitoneal space.

[0191] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the region of the kidney.

[0192] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member to extend from the second portion to the renal arteries.

[0193] In some embodiments, 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.

[0194] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member outside the peritoneum to extend from the second portion to the bladder.

[0195] In some embodiments, the step of positioning the transfer member comprises positioning the transfer member outside the peritoneum to extend from the second portion to the urethra.

[0196] In some embodiments, 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.

[0197] In some embodiments, the step of disposing the second portion comprises disposing the second portion comprising an electric motor.

[0198] In some embodiments, the step of disposing the second portion comprises disposing the second portion comprising a hydraulic pump.

[0199] In some embodiments, the step of disposing the second portion includes disposing the second portion including an energy storage unit.

[0200] In some embodiments, the step of disposing the second portion includes disposing the second portion including a receiver for wirelessly receiving at least one of the energy and the communication.

[0201] In some embodiments, the step of disposing the first portion includes disposing the first portion including a transmitter for wirelessly transmitting at least one of energy and communications.

[0202] In some embodiments, the step of disposing the second portion comprises disposing the second portion to comprise a controller responsible for controlling the powered medical device.

[0203] In some embodiments, the second portion is elongate and has a length axis extending substantially in an elongate direction of the second portion, and the step of positioning the second portion includes positioning the second portion so that the length axis is substantially parallel to a craniocaudal axis of the patient.

[0204] In some embodiments, the second portion is elongate and has a length axis extending substantially in an elongate direction of the second portion, and the step of positioning the second portion includes positioning the second portion so that the length axis is substantially perpendicular to a craniocaudal axis of the patient.

[0205] In some embodiments, the second portion is elongated and has a length 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 length axis of the second portion and pivoting or angling the second portion after the piercing is achieved.

[0206] In some embodiments, the step of placing a first portion of the implantable, energized medical device between the patient's skin and the layer of muscle tissue of the abdominal wall comprises placing the first portion in subcutaneous tissue.

[0207] In some embodiments, 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.

[0208] In some embodiments, the step of disposing the first portion includes disposing the first portion including an energy storage unit.

[0209] In some embodiments, the step of disposing the first portion includes disposing the first portion including a receiver for wirelessly receiving at least one of the energy and the communication.

[0210] In some embodiments, the step of disposing the first portion includes disposing the first portion including a transmitter for wirelessly transmitting at least one of energy and communications.

[0211] In some embodiments, the step of disposing the first portion comprises disposing the first portion to comprise a controller responsible for controlling the powered medical device.

[0212] In some embodiments, the first portion is elongate and has a length axis extending substantially in an elongate direction of the first portion, and the step of positioning the first portion includes positioning the first portion such that the length axis is substantially parallel to a craniocaudal axis of the patient.

[0213] In some embodiments, the first portion is elongate and has a length axis extending substantially in an elongate direction of the first portion, and the step of positioning the first portion includes positioning the first portion such that the length axis is substantially perpendicular to a craniocaudal axis of the patient.

[0214] In some embodiments, 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 includes positioning the first portion and the second portion such that the first portion major axis and the second portion major axis are positioned at an angle of greater than 30° relative to each other.

[0215] In some embodiments, the step of positioning the first portion and the second portion includes positioning the first portion and the second portion such that the first portion major axis and the second portion major axis are positioned at an angle of greater than 45° relative to one another.

[0216] In some embodiments, the method further comprises placing a connecting portion through at least one layer of abdominal wall musculature.

[0217] In some embodiments, the first moiety, second moiety and linking moiety are part of a single unit.

[0218] In some embodiments, the method further comprises linking the first portion to the linking portion in situ.

[0219] In some embodiments, the method further comprises connecting the second portion to the connecting portion in situ.

[0220] In some embodiments, the method further includes connecting a transfer member to the first portion.

[0221] In some embodiments, the method further comprises coupling a transfer member to the body engaging portion.

[0222] In some embodiments, the body engaging portion comprises a medical device for stretching the stomach wall to induce a feeling of fullness.

[0223] In some embodiments, the body engaging portion comprises a constriction device configured to constrict a hollow organ of the patient.

[0224] In some embodiments, the body engaging portion comprises an implantable retraction device.

[0225] In some embodiments, the implantable retraction device comprises an implantable retraction device for retracting a luminal organ of a patient.

[0226] In some embodiments, the implantable constriction device comprises an implantable constriction device for constricting the intestine of a patient.

[0227] In some embodiments, the implantable constriction device comprises an implantable constriction device for constricting the colon or rectum of a patient.

[0228] In some embodiments, the implantable contraction device comprises an implantable contraction device for contracting the intestine in the region of a patient's stoma.

[0229] In some embodiments, the implantable constriction device comprises an implantable constriction device for constricting a blood vessel in a patient.

[0230] In some embodiments, the implantable constriction device for constricting a patient's blood vessels is configured to constrict venous blood flow leading from the erectile tissue to facilitate anchoring of the erectile tissue.

[0231] In some embodiments, an implantable constriction device for constricting a patient's blood vessels is configured to constrict blood flow in the renal arteries to affect the patient's systemic blood pressure.

[0232] In some embodiments, the implantable constriction device comprises an implantable constriction device for constricting a blood vessel in a patient.

[0233] In some embodiments, the body engaging portion comprises an implantable element for actively emptying the patient's bladder.

[0234] In some embodiments, 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.

[0235] In some embodiments, the body engaging portion includes an element for electrically stimulating a tissue portion of the patient.

[0236] In accordance with one embodiment of the inventive concept, these and other objects are achieved in whole or at least in part by a kit for assembling an implantable, energized medical device configured to be held in place by a tissue portion of a patient, the kit including: one or more groups of first portions, one or more groups of second portions, one or more groups of connecting portions, at least one of said groups being composed of at least two different types of said respective portions; wherein the medical device is a modular device and, when assembled, is composed of a selection of one first portion, one second portion, and one connecting portion from said groups, wherein the first portion is 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 the first portion is configured to be held in place by a tissue portion. the first portion comprises a first surface configured to face a first tissue surface on the first side of the tissue portion, the second portion configured to be disposed on the 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 connecting portion configured to be disposed through an opening in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the first and second cross-sectional areas, so as to prevent movement of the first and second portions through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0237] In general, any of the embodiments of the implantable energized medical devices disclosed herein may form part of such a kit, and any of the features of such embodiments may be combined to form part of such a kit.

[0238] In some embodiments, the group of one or more first portions comprises a first portion including a first energy storage unit.

[0239] In some embodiments, the group of one or more first portions comprises a first portion including a first wireless energy receiving unit for receiving energy wirelessly transmitted by an external wireless energy transmitter.

[0240] In some embodiments, the first energy storage unit is connected to a first wireless energy receiver, and the first wireless energy receiver is configured to receive energy wirelessly transmitted by an external wireless energy transmitter and store the received energy in the first energy storage unit.

[0241] In some embodiments, the first wireless energy receiver is configured to be physically connected to a second energy storage unit of the second portion.

[0242] In some embodiments, the group of one or more first portions comprises a first portion that includes an internal wireless energy transmitter.

[0243] In some embodiments, the group of one or more second portions comprises a second portion including a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter.

[0244] In some embodiments, the internal wireless energy transmitter is configured to wirelessly transmit energy to a second wireless energy receiver.

[0245] In some embodiments, the group of one or more second portions comprises a second portion including a second energy storage unit connected to a second wireless energy receiver.

[0246] In some embodiments, 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.

[0247] In some embodiments, the group of one or more first portions comprises a first portion integrally formed with a connecting portion.

[0248] In some embodiments, the group of one or more second portions comprises a second portion integrally formed with the connecting portion.

[0249] In some embodiments, one of the groups of one or more first portions, second portions, or connecting portions comprises a first portion, a second portion, and a connecting portion formed as one integral unit.

[0250] In some embodiments, the group of one or more first portions includes a first portion having a first height along a direction perpendicular to the first plane and a first portion having a second height along the direction perpendicular to the first plane, the second height being greater than the first height.

[0251] In some embodiments, the group of one or more first portions includes a first portion having a first width and / or length along a direction parallel to the first plane and a first portion having a second width and / or length along the direction parallel to the first plane, the second width and / or length being greater than the first width and / or length.

[0252] In some embodiments, the group of one or more second portions includes a second portion having a first height along a direction perpendicular to the second plane and a second portion having a second height along the direction perpendicular to the second plane, the second height being greater than the first height.

[0253] In some embodiments, the group of one or more second portions includes a second portion having a first width and / or length along a direction parallel to the second plane and a second portion having a second width and / or length along the direction parallel to the second plane, the second width and / or length being greater than the first width and / or length.

[0254] In some embodiments, the group of one or more linking portions comprises linking portions having a first height along a direction perpendicular to the third plane and linking portions having a second height along the direction perpendicular to the third plane, the second height being greater than the first height.

[0255] In some embodiments, the group of one or more linking portions comprises linking portions having a first width and / or length along a direction parallel to the third plane and linking portions having a second width and / or length along said direction parallel to the third plane, the second width and / or length being greater than the first width and / or length.

[0256] In some embodiments, the group of one or more first portions comprises a first portion that includes an injection port for injecting a fluid into the first portion.

[0257] In some embodiments, the group of one or more connecting portions comprises a connecting portion including a hydraulic fluid conduit for hydraulically connecting a first portion to a second portion.

[0258] In some embodiments, the group of one or more first portions comprises a first portion including a first controller including at least one processing unit.

[0259] In some embodiments, the group of one or more second portions comprises a second portion including a second controller including at least one processing unit.

[0260] 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.

[0261] 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.

[0262] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0263] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0264] In some embodiments, the group of first portions comprises a first portion including a composite coil, the composite coil configured to wirelessly receive wireless energy from an external wireless energy transmitter and wirelessly transmit wireless energy to a second wireless receiver in the second portion.

[0265] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0266] In some embodiments, the group of one or more first portions comprises a first portion including a push button and / or a capacitive button for controlling a function of the implantable energized medical device.

[0267] The term "body tissue" as referred to in this disclosure may refer to one or more body tissue groups or layers of a patient, such as muscle tissue, connective tissue, bone, etc.

[0268] 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.

[0269] According to one embodiment, the first wireless transceiver comprises a UWB transceiver.

[0270] 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.

[0271] 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.

[0272] According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.

[0273] According to one embodiment, the external device is further configured to communicate with a second external device using said at least one wireless transceiver.

[0274] 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.

[0275] According to one embodiment, the communication range of the first network protocol is less than the communication range of the second network protocol.

[0276] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0277] 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.

[0278] 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.

[0279] According to one embodiment, the external device is one selected from a wearable external device and a handset.

[0280] An implantable medical device configured to communicate with an external device is provided, 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.

[0281] According to one embodiment, the first wireless transceiver comprises a UWB transceiver.

[0282] 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.

[0283] 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.

[0284] According to one embodiment, the second wireless transceiver comprises a Bluetooth transceiver.

[0285] 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.

[0286] 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.

[0287] According to one embodiment, the communication range of the first network protocol is less than the communication range of the second network protocol.

[0288] According to one embodiment, the frequency band of the first network protocol is different from the frequency band of the second network protocol.

[0289] 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.

[0290] 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.

[0291] According to one embodiment, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, an operable prosthetic heart valve to increase blood flow to the coronary arteries; implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; hydraulic, mechanical, and / or electrical contractile implants; an operable volumetric filling device; surgical gastric band, an operable implant for stretching the patient's stomach wall to produce a feeling of fullness; an implant configured to sense the frequency with which the patient consumes food; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; an implant-controlled medical device for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; Reservoir, implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; a maneuverable implant configured to be inserted into the patient's stomach to reduce the volume of the stomach substantially below the volume of the device; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, An artificial stomach that replaces the functions of a natural stomach an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0292] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0293] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0294] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0295] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0296] According to one embodiment, the system comprises a food sensor configured 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 stomach stretching after ingestion of a determined amount of food.

[0297] 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 to a patient display device configured to display the control interface to a user as a remote display portal, receive user input from the patient display device, and convert the user input into control commands for wireless transmission to the implantable medical device.

[0298] 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.

[0299] 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.

[0300] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient display device using standard network protocols.

[0301] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the implantable medical device using a proprietary network protocol.

[0302] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0303] According to one embodiment, at least one of the first and second wireless transceivers comprises a Bluetooth transceiver.

[0304] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0305] According to one embodiment, at least one of the first and second wireless transceivers comprises an UWB transceiver.

[0306] 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.

[0307] 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.

[0308] 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.

[0309] According to one embodiment, the communication range of the first wireless transceiver is less than the communication range of the second wireless transceiver.

[0310] According to one embodiment, at least one of the following: the patient-external device is configured to authenticate the implantable medical device when a 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 if 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 device when a distance between the patient external device and the patient display device is less than a predetermined threshold; The patient-external device is configured to be authenticated by the implantable medical device if the distance between the patient-external device and the patient display device is less than a predetermined threshold.

[0311] 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.

[0312] According to one embodiment, the computing device is configured to encrypt at least one of the control interface and the control commands.

[0313] According to one embodiment, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, an operable prosthetic heart valve to increase blood flow to the coronary arteries; implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; hydraulic, mechanical, and / or electrical contractile implants; an operable volumetric filling device; surgical gastric band, an operable implant for stretching the patient's stomach wall to produce a feeling of fullness; an implant configured to sense the frequency with which the patient consumes food; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; an implant-controlled medical device for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; Reservoir, implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; a maneuverable implant configured to be inserted into the patient's stomach to reduce the volume of the stomach substantially below the volume of the device; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, An artificial stomach that replaces the functions of a natural stomach an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0314] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0315] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0316] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0317] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0318] According to one embodiment, the system comprises a food sensor configured 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 stomach stretching after ingestion of a determined amount of food.

[0319] A patient display device for communicating with a patient remote external device for communicating with an implantable medical device is provided, 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.

[0320] 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 an 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.

[0321] 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 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.

[0322] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient remote external device using a proprietary network protocol.

[0323] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0324] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0325] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0326] 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.

[0327] 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.

[0328] According to one embodiment, the patient display device is a wearable external device or a handheld device.

[0329] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0330] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0331] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0332] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0333] According to one embodiment, the system comprises a food sensor configured to determine 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 stomach stretching after ingestion of a determined amount of food.

[0334] A communication system is provided that enables communication between a patient display device and an implantable medical device during implantation. 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 device. The computing device is configured to execute control software for creating control commands for operation of the implantable medical device, transmit the control interface to the patient display device, receive implant control user inputs generated by the patient display device from the server, and convert the user inputs into control commands for wireless transmission to the implantable medical device.

[0335] According to one embodiment, the computing device is configured to encrypt at least one of the control interface and the control commands.

[0336] According to one embodiment, the patient display device is configured to encrypt user input.

[0337] 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.

[0338] According to one embodiment, the computing device is configured to encrypt the control interface and the patient display device is configured to decrypt the encrypted control interface.

[0339] 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 decrypting them.

[0340] According to one embodiment of the communication system or patient display device, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, an operable prosthetic heart valve to increase blood flow to the coronary arteries; implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; hydraulic, mechanical, and / or electrical contractile implants; an operable volumetric filling device; surgical gastric band, an operable implant for stretching the patient's stomach wall to produce a feeling of satiety; an implant configured to sense the frequency with which the patient consumes food; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; an implant-controlled medical device for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; Reservoir, implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; a maneuverable implant configured to be inserted into the patient's stomach to reduce the volume of the stomach substantially below the volume of the device; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, An artificial stomach that replaces the functions of a natural stomach an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0341] 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.

[0342] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0343] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0344] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0345] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0346] According to one embodiment, the system comprises a food sensor configured 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 stomach stretching after ingestion of a determined amount of food.

[0347] A patient-external device for communicating with an implantable medical device and a patient display device for communicating during implantation are provided. 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 on the patient external device for a defined period of time using a secret key from the user.

[0348] According to one embodiment, the initial login is a PIN-based login.

[0349] According to one embodiment, at least one of the first and second logins is a login based on a biometric input or a hardware key.

[0350] 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.

[0351] 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 viewing portal that is displayed on the display.

[0352] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using standard network protocols.

[0353] According to one embodiment, the wireless communication unit is configured to wirelessly communicate with the patient-external device using a proprietary network protocol.

[0354] 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.

[0355] 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.

[0356] According to one embodiment, the wireless communication unit comprises a Bluetooth transceiver.

[0357] According to one embodiment, the wireless communication unit comprises a UWB transceiver.

[0358] 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.

[0359] According to one embodiment, the communication range of the wireless communication unit is smaller than the communication range of the auxiliary wireless communication unit.

[0360] 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.

[0361] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0362] 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.

[0363] 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.

[0364] According to one embodiment, the patient display device is a wearable external device or a handheld device.

[0365] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0366] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0367] 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.

[0368] According to one embodiment, the patient display device is configured to encrypt user input.

[0369] According to one embodiment, the display is configured to encrypt user input for decoding by the implantable medical device.

[0370] 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.

[0371] 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.

[0372] 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.

[0373] 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.

[0374] 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.

[0375] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices to the system via an HCP EID external device.

[0376] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0377] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0378] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0379] According to one embodiment, the system comprises a food sensor configured 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 stomach stretching after ingestion of a determined amount of food.

[0380] A communication system is provided that enables communication between a patient display device and an implantable medical device during implantation. 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 viewing portal. 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 a remote viewing 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 viewing portal of the patient remote external device for communication with the implantable medical device. The patient remote external device is configured to wirelessly transmit control commands to the implantable medical device based on the implant control input and includes a wireless communication unit configured to wirelessly communicate with the patient display device.

[0381] According to one embodiment, the patient display device has a first login function and a second login function, the first login function allowing a user to access a first application, and the combination of the first and second login functions allowing a user to access a second application.

[0382] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0383] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0384] According to one embodiment, the second application is configured to receive data relating to parameters relating to at least one of the following: Temperature, time, error.

[0385] According to one embodiment, the patient display device is configured to encrypt user input.

[0386] According to one embodiment, the display is configured to encrypt user input for decoding by the implantable medical device.

[0387] According to one embodiment, the patient remote external device is configured to act as a router that forwards encrypted user input from the patient display device to the implantable medical device without decrypting it.

[0388] According to one embodiment, the patient remote external device is configured to encrypt at least one of the control interface and the control commands.

[0389] 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.

[0390] There is provided a computer program product configured to run on a patient display device comprising a wireless communication unit, a display for displaying a received implant control interface as a remote viewing portal, and an input device for receiving implant control input from a user, the computer program product comprising: The first application to communicate with the server or DDI, a second application for communication with the patient remote external device for transmitting implant control inputs via a remote viewing portal of the patient remote external device for communication with the implantable medical device, the second application being configured to be accessed via the first application; A primary login function using at least one of the following: password, PIN code, fingerprint, or facial recognition; a second login function within the first application that authenticates a second hardware key of the patient remote external device for a defined period of time using a private key from the user, the first login function allowing the user to access the first application, and the combination of the first and second login functions allowing the user to access the second application.

[0391] According to one embodiment, the second application is configured to receive data relating to a parameter of the implanted medical device.

[0392] According to one embodiment, the second application is configured to receive data related to sensor values ​​received from the implanted medical device.

[0393] According to one embodiment, the second application is configured to receive data relating to parameters relating to at least one of the following: Temperature, time, error.

[0394] According to one embodiment of the communication system, patient display device or computer program product, the implantable medical device comprises at least one of the following: external cardiac compression devices, a device that assists the pumping function of a patient's heart; a pump function assist device comprising a turbine bump placed in a patient's blood vessel to assist the pumping function of the heart; steerable prosthetic heart valves, an operable prosthetic heart valve to increase blood flow to the coronary arteries; implantable drug delivery devices, an implantable drug delivery device that can inject directly into blood vessels and relocate the injection site; an implantable drug delivery device for injecting an efficacy-enhancing drug into the patient's erectile tissue; hydraulic, mechanical, and / or electrical contractile implants; an operable volumetric filling device; surgical gastric band, an operable implant for stretching the patient's stomach wall to produce a feeling of fullness; an implant configured to sense the frequency with which the patient consumes food; Operable cosmetic implants, manipulable cosmetic implants for adjusting the shape and / or size of a patient's breast area; an implant-controlled medical device for emptying the bladder; Implants to prevent urinary leakage implants to prevent anal incontinence, implants that control fecal excretion, implants to monitor aneurysms; implants to prevent the expansion of aneurysms; implants that lubricate joints, implants that affect blood flow to the patient's erectile tissue; implants to simulate erectile tissue expansion, implants with reservoirs for storing bodily fluids; implants that store and / or empty internal or surgically created reservoirs; Reservoir, implants that communicate with databases outside the body; Externally programmable implants, implants that can be programmed externally via wireless signals, Implants to treat impotence, An implant that controls the flow of eggs within the uterine canal, An implant that controls the flow of sperm within the uterine canal, An implant that controls the flow of sperm in the vas deferens, implants that block sperm transport in the vas deferens; implants to treat osteoarthritis, implants that test internal body parameters; implants that control specific treatment parameters from within the body; Implants that control body parameters from within the body, blood pressure control implants implants that control blood pressure by affecting the dilation of the renal arteries; implants that control drug treatment parameters; Implants that control blood parameters, implants for adjusting or replacing bone parts of the patient's body; Implants that replace a patient's organ or part of an organ or its function; vascular treatment equipment, implants that move fluid within a patient's body; an implant configured to sense a parameter associated with swallowing in a patient; an implant configured to exercise muscles by electrical or mechanical stimulation; an implant configured to empty a portion of the intestinal tract on command; a maneuverable implant configured to be inserted into the patient's stomach to reduce the volume of the stomach substantially below the volume of the device; an implant configured to compress the bladder to empty the bladder from within the patient; an implant configured to drain fluid from within a patient's body; an implant configured to apply lubricating fluid to the joint to actively lubricate it; an implant configured to remove blood clots and particles from a patient's bloodstream; an implant configured to lengthen or correct a patient's bone to reduce scoliosis; Brain stimulation devices, An artificial stomach that replaces the functions of a natural stomach an implant configured to adjust the position of the female urethra or bladder neck; An implant configured to stimulate the vascular ampulla, causing temporary constriction.

[0395] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0396] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0397] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0398] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0399] According to one embodiment, the system comprises a food sensor configured 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 stomach stretching after ingestion of a determined amount of food.

[0400] A communication system is provided that enables communication between a patient display device, an external patient device, a server, and an implantable medical device. The communication system comprises a server; A patient display device, a patient external device, and an implantable medical device. The patient display device includes a wireless communication unit for wirelessly communicating with at least one of the patient external device and a 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 functioning as a router forwarding the data without full decryption. In one embodiment, the implantable medical device includes 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 functioning as a router forwarding the data without full decryption. In one embodiment, the server comprises an encryption unit and is configured to: encrypt data destined for the implantable medical device and send the data to the implantable medical device via the patient external device, with the patient external device acting as a router that forwards the data without full decryption; encrypt data destined for the implantable medical device and send 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 that forwards the data without full decryption. In one embodiment, the patient display comprises an encryption unit and is configured to encrypt data destined for the implantable medical device and send the data to the implantable medical device 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 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.

[0401] 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.

[0402] 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.

[0403] 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.

[0404] 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.

[0405] 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.

[0406] 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.

[0407] 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.

[0408] 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.

[0409] 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.

[0410] 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.

[0411] 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.

[0412] 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.

[0413] 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.

[0414] 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 patient display device, the second wireless transceiver having a longer effective range than the first wireless transceiver.

[0415] 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.

[0416] According to one embodiment, the second wireless transceiver has one of the following ranges: 2x, 4x, 8x, 20x, 50x, or 100x.

[0417] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0418] According to one embodiment, at least one of the following: the patient display device is configured to authenticate the patient external device when a distance between the patient display device and the patient external device is less than a predetermined threshold; the patient display device is configured to be authenticated by the patient-external device if the distance between the patient display device and the patient-external device is less than a predetermined threshold; the patient display device is configured to authenticate the implantable medical device when a distance between the patient display device and the implantable medical device is less than a predetermined threshold; the patient display device is configured to be authenticated by the implantable medical device when a distance between the patient display device and the implantable medical device is less than a predetermined threshold; the patient-external device is configured to authenticate the patient display device when a distance between the patient-external device and the patient display device is less than a predetermined threshold; The patient-external device is configured to be authenticated by the patient display device if the distance between the patient-external device and the patient display device is less than a predetermined threshold; the patient-external device is configured to authenticate the implantable medical device when a 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 if the distance between the patient-external device and the implantable medical device is less than a predetermined threshold.

[0419] 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.

[0420] 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.

[0421] 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.

[0422] According to one embodiment, the patient display device is a wearable external patient device or a handheld device.

[0423] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0424] There is provided a server for use in a communication system according to any one of the above embodiments.

[0425] There is provided a patient display device for use in a communication system according to any one of the above embodiments.

[0426] There is provided a patient external device for use in a communication system according to any one of the above embodiments.

[0427] There is provided an implantable medical device for use in a communication system according to any one of the above embodiments.

[0428] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0429] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0430] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0431] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0432] According to one embodiment, the system comprises a food sensor configured to determine 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 stomach stretching after ingestion of a determined amount of food.

[0433] A system configured to remotely change preprogrammed therapy settings of an implantable medical device implanted in a patient is provided. The system comprises at least one healthcare provider (HCP), an EID external device, and an HCP private key device. The HCP EID external device is configured to receive commands from the HCP to change the preprogrammed therapy settings of the implanted medical device and is further configured 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 configured 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 comprises 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 configured 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 one wireless transceiver configured to communicate with the patient external device and a patient EID external device configured to receive the commands relayed by the DDI, the implanted medical device further configured to transmit the commands to the implanted medical device, and 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 configured to be activated, authenticated, and authorized to execute the commands by the patient providing 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 contact.The patient EID external device comprises 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. 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. Further, the implanted medical device is configured to treat the patient or perform a bodily function.

[0434] According to one embodiment, at least one of the Patient Private Key Device or the HCP Private Key Device comprises a hardware key.

[0435] 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.

[0436] 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.

[0437] 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.

[0438] 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.

[0439] 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.

[0440] 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.

[0441] 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.

[0442] 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.

[0443] 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.

[0444] 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.

[0445] 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.

[0446] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0447] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0448] 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.

[0449] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0450] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0451] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0452] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0453] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0454] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0455] According to one embodiment, the system comprises a food sensor configured to determine 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 stomach stretching after ingestion of a determined amount of food.

[0456] A system configured to change preprogrammed therapy settings of an implantable medical device by a healthcare provider (HCP) in the patient's physical presence when implanted in the patient is provided. The system includes at least one HCP EID external device configured to receive commands, directly or indirectly, from the HCP to change the preprogrammed therapy settings of the implantable medical device when the implantable medical device is implanted. The HCP EID external device is further configured to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device comprising an HCP private key. The HCP private key device may be at least one of a smart card, a key fob device, a watch, a wristband, a necklace, and any shape of device. The HCP EID external device is configured 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 configured 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.

[0457] 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.

[0458] According to one embodiment, the HCP private key device is configured 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.

[0459] 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.

[0460] According to one embodiment, the HCP EID external device, when implanted, is configured to receive commands from the HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further configured to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0461] 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.

[0462] 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.

[0463] 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.

[0464] 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.

[0465] 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.

[0466] 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.

[0467] 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.

[0468] 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.

[0469] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0470] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0471] 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.

[0472] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0473] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0474] A system configured to change a preprogrammed and preselected therapeutic operation of an implantable medical device implanted in a patient based on a patient's command is provided. 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 express 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 device 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 device.

[0475] According to one embodiment, the wireless transceiver, the remote viewing portal, and the remote viewing portal are configured within a patient remote external device.

[0476] 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.

[0477] According to one embodiment, the remote display portal can generate commands that are signed with the patient display device's private key.

[0478] According to one embodiment, the patient remote external device is configured to accept input from the patient via the patient display device via its remote display portal.

[0479] 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.

[0480] 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.

[0481] 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.

[0482] 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.

[0483] 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.

[0484] According to one embodiment, the patient EID external device is configured to synchronize with the patient remote external device.

[0485] 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.

[0486] According to one embodiment, the patient EID external device is configured to generate an authorization signed by a patient private key installed on at least one of the patient remote external device and the implantable medical device via the patient EID external device.

[0487] 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.

[0488] According to one embodiment, the remote viewing portal and the patient remote external device are configured to expose buttons for the patient to indicate their intent to activate functions of the implantable medical device through the patient remote external device.

[0489] 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.

[0490] According to one embodiment, the Remote Display Portal can generate commands that are signed with a patient private key.

[0491] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0492] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0493] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0494] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0495] According to one embodiment, the system comprises a food sensor configured to determine 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 stomach stretching after ingestion of a determined amount of food.

[0496] 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 configured to receive information from the implant and further configured to transmit such information to a server or dedicated data infrastructure (DDI), and further configured 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 configured 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 contact. The patient EID external device further includes at least one wireless transceiver configured to communicate with the DDI via a first network protocol.

[0497] According to one embodiment, the at least one patient EID external device is configured to receive information from the implant via a second network protocol.

[0498] According to one embodiment, the system comprises a DDI configured to receive information from the patient EID external device, the DDI comprising a wireless transceiver configured to communicate with the patient EID external device.

[0499] According to one embodiment, the patient EID external device is configured to receive commands relayed by the DDI, and further configured to send commands to the implanted medical device to change the pre-programmed therapy settings of the implanted medical device, and further configured to be activated, authenticated, and authorized to execute the commands by the patient providing a patient private key.

[0500] According to one embodiment, the patient private key device is configured to allow 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.

[0501] 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.

[0502] According to one embodiment, the patient EID external device further comprises at least one wireless transceiver configured to communicate with the implanted medical device via a second network protocol.

[0503] According to one embodiment, the system comprises an implantable medical device that, when implanted, is adapted to treat a patient or perform a bodily function.

[0504] According to one embodiment, the patient private key is configured in at least one of a smart card, a key fob device, a watch, an armband or wristband, a necklace, and a device of any shape.

[0505] 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.

[0506] 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.

[0507] 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.

[0508] 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.

[0509] 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.

[0510] 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.

[0511] 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.

[0512] 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.

[0513] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0514] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0515] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0516] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0517] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0518] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0519] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0520] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0521] According to one embodiment, the system comprises a food sensor configured to determine 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 stomach stretching after ingestion of a determined amount of food.

[0522] A system is provided that includes an implantable medical device configured to communicate with an external device when implanted in a patient, the external device including at least one of a patient remote external device or a patient EID external device. The system further includes a patient EID external device configured to communicate with the implantable medical device when implanted, send commands to the implantable medical device, and change preprogrammed settings, and a patient private key device including a patient private key configured to activate, authenticate, and execute the commands by the patient EID external device, the private key being configured 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 includes a data infrastructure server (DDI) configured 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.

[0523] 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.

[0524] 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.

[0525] According to one embodiment, the system comprises a DDI configured 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 the patient external device.

[0526] According to one embodiment, the patient EID external device is configured to receive a command from the DDI, the command originating from a healthcare provider (HCP), and the patient EID is configured to deactivate the patient private key and send the command to the implanted medical device.

[0527] According to one embodiment, the patient EID external device is configured to receive a command from a DDI, the command originating from a healthcare provider (HCP), the patient EID external device is configured 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 configured to transmit the command to the implanted medical device.

[0528] 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.

[0529] According to one embodiment, at least one of the patient private key and the patient remote external device private key comprises a hardware key.

[0530] 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.

[0531] 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.

[0532] 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.

[0533] 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.

[0534] 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.

[0535] 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.

[0536] 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.

[0537] 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.

[0538] 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.

[0539] According to one embodiment, the second wireless transceiver has a range that is one of the following: 2x, 4x, 8x, 20x, 50x or 100x.

[0540] According to one embodiment, the second wireless transceiver is configured to be disabled to allow wireless communication using the first wireless transceiver.

[0541] According to one embodiment, the patient EID external device is a wearable patient external device or handset.

[0542] According to one embodiment, the data encrypted by the implantable medical device relates to at least one of battery status, temperature, time, and errors.

[0543] According to one embodiment, the system comprises a master private key device configured to allow the issuance of new private key devices, and has such master private key device configured to allow an HCP or HCP administrator to exchange and pair new patient private key devices or HCP private key devices with the system via an HCP EID external device.

[0544] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

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

[0546] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0547] According to one embodiment, the system comprises a food sensor configured to determine 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 stomach stretching after ingestion of a determined amount of food.

[0548] 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 configured 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 configured 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 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 configured 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.

[0549] 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.

[0550] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0551] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0552] According to one embodiment, the system further comprises a measurement device or sensor configured to provide measurements to at least one of the DDI, the patented EID external device, and the patient display device.

[0553] According to one embodiment, the system further comprises a food sensor configured 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 to trigger stomach stretching after ingestion of a determined amount of food.

[0554] 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.

[0555] According to one embodiment, the HCP private key device is configured 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.

[0556] 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.

[0557] According to one embodiment, the HCP EID external device, when implanted, is configured to receive commands from the HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further configured to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0558] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0559] 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.

[0560] 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.

[0561] 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.

[0562] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0563] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0564] A system configured for changing preprogrammed therapy settings in an implantable medical device by a healthcare provider (HCP) remotely from the patient when implanted in the patient is provided. The system includes at least one HCP EID external device configured to receive commands directly or indirectly from the HCP to change the preprogrammed therapy settings in the implantable medical device when implanted, the HCP EID external device being further configured 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 when the implantable medical device is implanted are configured to be authenticated by an HCP private key device and a patient private key device.

[0565] 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.

[0566] 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.

[0567] According to one embodiment, the patient private key is configured to be able to initiate, authenticate, and execute said commands provided by the HCP via the HCP EID external device or when the action is performed remotely via the patient EID external device.

[0568] 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.

[0569] 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 has such master private key device configured to allow new patient private key devices or HCP private key devices to be replaced and paired with the system.

[0570] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0571] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0572] According to one embodiment, the system further comprises a measurement device or sensor configured to provide measurements to at least one of the DDI, the patent EID external device, and the patient display device.

[0573] According to one embodiment, the system comprises a food sensor configured to determine 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 a stomach stretching action after ingestion of a determined amount of food.

[0574] 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.

[0575] According to one embodiment, the HCP private key device is configured 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.

[0576] 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.

[0577] According to one embodiment, the HCP EID external device, when implanted, is configured to receive commands from the HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further configured to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0578] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0579] 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.

[0580] 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.

[0581] 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.

[0582] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0583] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0584] 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) external device configured to receive commands from an HCP to change the preprogrammed therapy settings of the implantable medical device. The HCP external device is further configured to be activated, authenticated, and authorized to execute the commands by the HCP providing an HCP private key device configured 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 comprises a patient EID external device configured to receive commands from the HCP-external device and relay the received commands to an 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 configured to transmit 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 configured 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.

[0585] According to one embodiment, at least one of the patient private key device or the HCP private key device comprises a hardware key.

[0586] 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.

[0587] 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.

[0588] According to one embodiment, the patient remote external device and the patient EID external device are an integrated unit.

[0589] According to one embodiment, the HCP dedicated device and the HCP EID external device are an integrated unit.

[0590] According to one embodiment, the system includes a measurement device or sensor configured to provide measurements to at least one of a DDI, a patented EID external device, and a patient display device.

[0591] According to one embodiment, the system comprises a food sensor configured to determine 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 a stomach stretching action after ingestion of a determined amount of food.

[0592] 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.

[0593] According to one embodiment, the HCP private key device is configured 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 near field wireless activation communication unit, or direct electrical contact.

[0594] 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.

[0595] According to one embodiment, the HCP EID external device, when implanted, is configured to receive commands from the HCP dedicated device to modify the pre-programmed therapy steps of the implantable medical device, and the HCP dedicated device is further configured to be activated, authenticated, and authorized to execute the commands by the HCP providing its private key.

[0596] According to one embodiment, the HCP EID external device and the HCP private key device are configured for wireless communication using standard network protocols.

[0597] 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.

[0598] 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.

[0599] 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.

[0600] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.

[0601] According to one embodiment, at least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.

[0602] 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 having a second cross-sectional area in a second plane facing the first side and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through a hole in the tissue portion extending between the first side and the second side of the tissue portion. The connecting portion has a third cross-sectional area in a third plane and is configured to connect the first portion to the second portion, wherein the first 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 to prevent the first portion and the second portion from moving through a hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane, and the connecting portion and the second portion are configured to form a connecting interface between the connecting portion and the second portion, wherein the second portion extends along a first direction parallel to the second plane, the second portion has a longitudinal cross-sectional area along the first direction, the second longitudinal cross-sectional area being smaller than the first longitudinal cross-sectional area, and the first longitudinal cross-sectional area is located closer to the connecting interface with respect to the first direction.

[0603] In some embodiments, the second portion has a first end and a second end opposite the first end along the first direction, the second portion has a length between the first end and the second end, the second portion has an intermediate region and a distal region, the intermediate region is defined by a connection interface between the connecting portion and the second portion, and the distal region extends from the connection interface between the connecting portion and the second portion to the second end.

[0604] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the second end.

[0605] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the second end.

[0606] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the second end.

[0607] In some embodiments, the distal region of the second portion is conical.

[0608] In some embodiments, the second portion has rotational symmetry along the first direction.

[0609] In some embodiments, the second surface of the second portion is substantially perpendicular to the central extension of the connecting portion.

[0610] In some embodiments, the second surface of the second portion is substantially parallel to the second plane.

[0611] In some embodiments, the second surface of the second portion is substantially flat and configured to form a contact area against the second tissue surface, and the second portion further comprises a lower surface facing away from the first portion configured to taper toward the second end.

[0612] In some embodiments, the second portion has a proximal region that extends from the first end to a connection interface between the connecting portion and the second portion.

[0613] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the first end.

[0614] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the first end.

[0615] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the first end.

[0616] In some embodiments, the proximal region of the second portion is conical.

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

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

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

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

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

[0622] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0623] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0624] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion in a first direction but not in a second direction perpendicular to the first direction.

[0625] In some embodiments, the connection interface between the connecting portion and the second portion is eccentric relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0626] In some embodiments, the second direction is parallel to a second plane.

[0627] In some embodiments, the proximal and distal regions comprise a second surface configured to engage a second surface of a second side of the tissue portion.

[0628] In some embodiments, the second portion tapers from the first end to the second end.

[0629] In some embodiments, the second portion tapers from an intermediate region of the second portion to each of the first and second ends.

[0630] In some embodiments, the first portion has a maximum dimension in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0631] In some embodiments, the first portion has a diameter in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0632] In some embodiments, the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, for example in the range of 5 to 10 mm.

[0633] In some embodiments, the second portion has a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 35 to 60 mm.

[0634] In some embodiments, the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flattened disk shape.

[0635] In some embodiments, the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane.

[0636] In some embodiments, the distal region is configured to face downward in a standing patient.

[0637] In some embodiments, the first portion has a first height and the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, and the first height being less than the second height.

[0638] In some embodiments, the first height is less than 2 / 3 of the second height, such as less than 1 / 2 of the second height, such as less than 1 / 3 of the second height.

[0639] In some embodiments, the second end of the second portion comprises a connection portion for connecting to an implant located caudally from the location of the implantable energized medical device within the patient.

[0640] In some embodiments, the first end of the second portion comprises a connection for connecting to an implant located cranially from the location of the implantable energized medical device within the patient.

[0641] In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0642] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0643] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0644] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0645] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0646] In some embodiments, the second portion comprises a second wireless energy receiver.

[0647] In some embodiments, the first portion comprises a first energy storage unit.

[0648] In some embodiments, the second portion comprises a second energy storage unit.

[0649] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0650] In some embodiments, the solid state battery is a thionyl chloride battery.

[0651] 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.

[0652] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0653] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0654] 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.

[0655] 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.

[0656] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0657] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0658] 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.

[0659] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0660] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least a 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.

[0661] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0662] 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.

[0663] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0664] In some embodiments, the implantable energized medical device further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0665] In some embodiments, the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.

[0666] In some embodiments, the sensor is configured to sense at least one of a temperature of the implantable energized medical device or body-engaging portion, a parameter related to power consumption of the implantable energized medical device or body-engaging 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.

[0667] In some embodiments, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0668] In some embodiments, the sensor is a sensor 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.

[0669] In some embodiments, 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.

[0670] In some embodiments, the sensor configured to sense pH is configured to sense acidity in the stomach.

[0671] In some embodiments, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0672] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0673] In some embodiments, the second portion comprises at least one electric motor.

[0674] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion generated by the electric motor.

[0675] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0676] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0677] In some embodiments, the transmission comprises a gear system.

[0678] 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.

[0679] In some embodiments, the second portion comprises at least one hydraulic pump.

[0680] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0681] In some embodiments, the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor being configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0682] In some embodiments, at least one of the first and second portions comprises a sensation generator configured to generate a sensation detectable by the patient's senses.

[0683] In some embodiments, the second portion includes a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0684] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit a force from the second portion to the implant engaging portion.

[0685] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted implant engaging portion.

[0686] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0687] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0688] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0689] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0690] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0691] In some embodiments, 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, wherein the first and second hydraulically actuatable implant elements are adjustable independently of one another.

[0692] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0693] In some embodiments, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0694] In some embodiments, the implantable energized medical device further comprises a first pressure sensor configured to sense a pressure in the first hydraulic system and a second pressure sensor configured to sense a pressure in the second hydraulic system.

[0695] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0696] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0697] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0698] In accordance with one embodiment of the present concept, there is provided an implantable device for exerting a force on a body part of a patient, the implantable device comprising an implantable energized medical device and an implantable element configured to exert a force on the body part of the patient.

[0699] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constrictor.

[0700] In some embodiments, the implantable hydraulic constriction device is configured to constrict a luminal organ of a patient.

[0701] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the patient's intestine.

[0702] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the colon or rectum of a patient.

[0703] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine in the region of the patient's stoma.

[0704] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel of a patient.

[0705] In some embodiments, the implantable hydraulic constriction device for constricting a patient's blood vessels is configured to constrict venous blood flow leading from the erectile tissue to facilitate anchoring of the erectile tissue.

[0706] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel of a patient.

[0707] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively emptying the patient's bladder.

[0708] In some embodiments, 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.

[0709] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively stretching the patient's stomach wall to induce a feeling of satiety.

[0710] 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 including a third surface configured to engage the 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, where hereinafter the first plane, second plane, and third plane are parallel to one another, the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area, and the first portion, second portion, and connecting portion are prevented from moving through a hole in the tissue portion in a direction perpendicular to the first plane, second plane, and third plane, and the first portion is configured to be movable relative to the connecting portion and / or is composed of a first element and a second element, and the first element is configured to move relative to the second element to increase the area of ​​the first surface.

[0711] In some embodiments, the connecting portion is configured to extend along a central extension between the first portion and the second portion, and the first portion is configured to be movable to assume several positions along a direction perpendicular to the central extension.

[0712] In some embodiments, the first portion is configured to be secured in multiple positions by a locking mechanism disposed on either or both of the first portion and the connecting portion.

[0713] In some embodiments, the first element is configured to have a first state in which the first element is disposed on or within the second element, and a second state in which the first element is disposed adjacent to the second element.

[0714] In some embodiments, the first element is hingedly connected to the second element.

[0715] In some embodiments, the first element and the second element are integrally formed, and the first portion has flexibility that allows the first element to be folded over the second element into the first state.

[0716] In some embodiments, the second element comprises a slot, and the first element is configured to be partially or fully received within the slot in the first state, and the first element is configured to protrude from the slot in the second state.

[0717] In some embodiments, the first element comprises a slot, the second element is configured to be partially or fully received within the slot in a first state of the second element, and the second element is configured to protrude from the slot in a second state of the second element.

[0718] In some embodiments, the first element is configured to rotate about an axis parallel to said central extension.

[0719] In some embodiments, the first element is configured to rotate up to 180 degrees about the axis.

[0720] In some embodiments, the first element is configured to rotate up to 90 degrees about the axis.

[0721] In some embodiments, the second element is configured to be coupled to the linking portion.

[0722] In some embodiments, the first element is configured to move relative to the second element to protrude or protrude further beyond the end of the second element to increase the area of ​​the first surface.

[0723] In some embodiments, the second element is movable relative to the first element to increase the area of ​​the first surface.

[0724] In some embodiments, the first element and the second element are configured to move from a first state in which the ends of the first element and the second element each point in a direction substantially perpendicular to a first plane to a second state in which the ends of the first element and the second element each point in one or more directions substantially parallel to the first plane.

[0725] In some embodiments, the first element and the second element are configured to assume an upright position extending away from the connecting portion and to move toward a lateral position substantially perpendicular to the upright position.

[0726] In some embodiments, the connecting portion comprises a protruding element and the first portion comprises a slot, the protruding element configured to slide within the slot along a predetermined path.

[0727] In some embodiments, the protruding elements are configured to be interlocked within the slots such that the protruding elements can only be removed from the slots at preset positions.

[0728] In some embodiments, the protruding element is configured to be interlocked within the slot such that the protruding element is permanently enclosed within the slot, or the protruding element is configured to be interlocked within the slot such that the protruding element is permanently enclosed within the slot.

[0729] In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0730] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0731] In some embodiments, the connecting portion includes a flange defining a fourth cross-sectional area, the flange being configured to be prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0732] In some embodiments, the flanges project in directions parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0733] In some embodiments, the flange comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0734] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0735] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0736] In some embodiments, the second portion comprises a second wireless energy receiver.

[0737] In some embodiments, the first portion comprises a first energy storage unit.

[0738] In some embodiments, the second portion comprises a second energy storage unit.

[0739] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0740] In some embodiments, the solid state battery is a thionyl chloride battery.

[0741] 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.

[0742] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0743] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0744] 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.

[0745] 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.

[0746] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0747] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0748] 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.

[0749] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0750] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least a 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.

[0751] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0752] 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.

[0753] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0754] In some embodiments, the implantable energized medical device further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0755] In some embodiments, the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.

[0756] In some embodiments, the sensor is configured to sense at least one of a temperature of the implantable energized medical device or body-engaging portion, a parameter related to power consumption of the implantable energized medical device or body-engaging 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.

[0757] In some embodiments, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0758] In some embodiments, the sensor is a sensor 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.

[0759] In some embodiments, 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.

[0760] In some embodiments, the sensor configured to sense pH is configured to sense acidity in the stomach.

[0761] In some embodiments, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0762] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0763] In some embodiments, the second portion comprises at least one electric motor.

[0764] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion generated by the electric motor.

[0765] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0766] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0767] In some embodiments, the transmission comprises a gear system.

[0768] 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.

[0769] In some embodiments, the second portion comprises at least one hydraulic pump.

[0770] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0771] In some embodiments, the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0772] In some embodiments, at least one of the first and second portions comprises a sensation generator configured to generate a sensation detectable by the patient's senses.

[0773] In some embodiments, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0774] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit a force from the second portion to the implant engaging portion.

[0775] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted implant engaging portion.

[0776] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0777] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0778] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0779] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0780] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0781] In some embodiments, 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, wherein the first and second hydraulically actuatable implant elements are adjustable independently of one another.

[0782] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0783] In some embodiments, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0784] In some embodiments, the implantable energized medical device further comprises a first pressure sensor configured to sense a pressure in the first hydraulic system and a second pressure sensor configured to sense a pressure in the second hydraulic system.

[0785] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0786] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0787] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0788] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0789] In some embodiments, the third cross-sectional area is equal to or greater than the first cross-sectional area.

[0790] An implantable apparatus for exerting a force on a body part of a patient is provided, the apparatus comprising an implantable energized medical device and an implantable element configured to exert a force on the body part of the patient.

[0791] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constrictor.

[0792] In some embodiments, the implantable hydraulic constriction device is configured to constrict a luminal organ of a patient.

[0793] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the patient's intestine.

[0794] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the colon or rectum of a patient.

[0795] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine in the region of the patient's stoma.

[0796] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel in a patient.

[0797] In some embodiments, the implantable hydraulic constriction device for constricting a patient's blood vessels is configured to constrict venous blood flow leading from the erectile tissue to facilitate anchoring of the erectile tissue.

[0798] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel in a patient.

[0799] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively emptying the patient's bladder.

[0800] In some embodiments, 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.

[0801] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively stretching the patient's stomach wall to induce a feeling of satiety.

[0802] 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 including a third surface configured to engage the 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, wherein the first plane, second plane, and third plane are parallel to one another, the third cross-sectional area is smaller than the second cross-sectional area, and the first portion, second portion, and connecting portion are prevented from moving through a hole in the tissue portion in a direction perpendicular to the first plane, second plane, and third plane, and the first portion is 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 is configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level, the frequency level being 100 kHz.

[0803] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0804] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency above the frequency level to an external device.

[0805] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0806] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0807] 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.

[0808] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0809] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0810] 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.

[0811] 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.

[0812] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0813] 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.

[0814] In some embodiments, the second portion comprises an outer casing made of titanium.

[0815] 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.

[0816] 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; 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 a tissue portion extending between a first side and a second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, so that the first portion, the second portion, and the connecting portion are prevented from moving through the opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane, and the first portion is configured to receive and / or transmit electromagnetic waves at a frequency less than a frequency level, the frequency level being 100 kHz.

[0817] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0818] 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.

[0819] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to an external device.

[0820] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0821] In some embodiments, the electromagnetic waves comprise wireless energy and / or wireless communications.

[0822] 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.

[0823] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0824] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0825] 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.

[0826] 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.

[0827] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0828] In some embodiments, the first portion comprises an outer casing made of titanium.

[0829] 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.

[0830] In some embodiments, the second portion comprises an outer casing made of titanium.

[0831] 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.

[0832] 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 including a third surface configured to engage the 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, where hereinafter the first plane, second plane, and third plane are parallel to one another, and the third cross-sectional area is smaller than the second cross-sectional area, so as to prevent the first portion, second portion, and connecting portion from moving through the hole in the tissue portion in a direction perpendicular to the first plane, second plane, and third plane, and the first portion is made from a polymeric material and the second portion is composed of a casing made from titanium, the casing forming a complete housing.

[0833] 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.

[0834] In some embodiments, the first portion comprises a casing made from a polymeric material.

[0835] 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.

[0836] 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.

[0837] In some embodiments, the joint is disposed in the joint core such that it is sealed by the outer material of the joint.

[0838] In some embodiments, the coupling portion comprises a ceramic material.

[0839] In some embodiments, the connections are encapsulated in a ceramic material.

[0840] In some embodiments, the first portion comprises a first connecting portion configured to connect to a connecting portion of the connecting portion.

[0841] In some embodiments, the second portion comprises a second connecting portion configured to connect to the connecting portion of the connecting portion.

[0842] In some embodiments, the casing of the second portion is hermetically sealed.

[0843] In some embodiments, the second connection is positioned such that the hermetic seal of the second portion remains intact.

[0844] In some embodiments, the casing of the first portion is sealed.

[0845] 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 including a third surface configured to engage the 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, wherein hereinafter the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, and the first portion, the second portion, and the connecting portion are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; 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 has a substantially constant cross-sectional area along the central extension axis, or the connecting portion has a cross-sectional area that decreases in a direction from the first portion to the second portion along the central extension axis, and / or the second portion has a substantially constant cross-sectional area along the longitudinal direction, or the second portion has a cross-sectional area that decreases in a longitudinal direction.

[0846] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0847] In some embodiments, the connecting portion tapers along the central extension axis in a direction from the first portion to the second portion.

[0848] 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.

[0849] In some embodiments, the second portion is tapered in its length.

[0850] In some embodiments, the connecting portion has a circular or elliptical cross section that decreases in diameter along its length.

[0851] 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.

[0852] In some embodiments, the length direction extends substantially perpendicular to the central elongation axis.

[0853] In some embodiments, the connecting portion comprises a protruding element and the first portion comprises a slot, the protruding element configured to slide within the slot along a predetermined path.

[0854] In some embodiments, the protruding elements are configured to be interlocked within the slots such that the protruding elements can only be removed from the slots at preset positions.

[0855] In some embodiments, the protruding element is configured to be interlocked within the slot such that the protruding element is permanently enclosed within the slot, or the protruding element is configured to be interlocked within the slot such that the protruding element is permanently enclosed within the slot.

[0856] In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0857] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0858] In some embodiments, the connecting portion includes a flange defining a fourth cross-sectional area, the flange being configured to be prevented from moving through the hole in the tissue portion in a direction perpendicular to the first, second, and third planes.

[0859] In some embodiments, the flanges project in directions parallel to the first, second, third and fourth planes and perpendicular to the central extension of the connecting portion.

[0860] In some embodiments, the flange comprises a third surface configured to engage a first tissue surface on the first side of the tissue portion.

[0861] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0862] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0863] In some embodiments, the second portion comprises a second wireless energy receiver.

[0864] In some embodiments, the first portion comprises a first energy storage unit.

[0865] In some embodiments, the second portion comprises a second energy storage unit.

[0866] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0867] In some embodiments, the solid state battery is a thionyl chloride battery.

[0868] 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.

[0869] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0870] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0871] 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.

[0872] 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.

[0873] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0874] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0875] 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.

[0876] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0877] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least a 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.

[0878] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0879] 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.

[0880] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0881] In some embodiments, the implantable energized medical device further comprises at least one sensor for providing input to at least one of the first and second controllers.

[0882] In some embodiments, the sensor is a sensor configured to sense a physical parameter of the implantable energized medical device.

[0883] In some embodiments, the sensor is configured to sense at least one of a temperature of the implantable energized medical device or body-engaging portion, a parameter related to power consumption of the implantable energized medical device or body-engaging 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.

[0884] In some embodiments, the sensor is a sensor configured to sense a physiological parameter of the patient.

[0885] In some embodiments, the sensor is a sensor 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.

[0886] In some embodiments, 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.

[0887] In some embodiments, the sensor configured to sense pH is configured to sense acidity in the stomach.

[0888] In some embodiments, the controller is configured to transmit information based on the sensor input to a device external to the patient's body.

[0889] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0890] In some embodiments, the second portion comprises at least one electric motor.

[0891] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion generated by the electric motor.

[0892] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0893] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0894] In some embodiments, the transmission comprises a gear system.

[0895] 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.

[0896] In some embodiments, the second portion comprises at least one hydraulic pump.

[0897] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0898] In some embodiments, the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor being configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0899] In some embodiments, at least one of the first and second portions comprises a sensation generator configured to generate a sensation detectable by the patient's senses.

[0900] In some embodiments, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0901] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit a force from the second portion to the implant engaging portion.

[0902] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted implant engaging portion.

[0903] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0904] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0905] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0906] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0907] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0908] In some embodiments, 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, wherein the first and second hydraulically actuatable implant elements are adjustable independently of one another.

[0909] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0910] In some embodiments, the first and second hydraulic systems each include a reservoir for holding hydraulic fluid.

[0911] In some embodiments, the implantable energized medical device further comprises a first pressure sensor configured to sense a pressure in the first hydraulic system and a second pressure sensor configured to sense a pressure in the second hydraulic system.

[0912] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0913] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0914] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0915] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0916] In some embodiments, the third cross-sectional area is equal to or greater than the first cross-sectional area.

[0917] An implantable apparatus for exerting a force on a body part of a patient is provided, the apparatus comprising an implantable energized medical device and an implantable element configured to exert a force on the body part of the patient.

[0918] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constrictor.

[0919] In some embodiments, the implantable hydraulic constriction device is configured to constrict a luminal organ of a patient.

[0920] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the patient's intestine.

[0921] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the colon or rectum of a patient.

[0922] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine in the region of the patient's stoma.

[0923] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel of a patient.

[0924] In some embodiments, the implantable hydraulic constriction device for constricting a patient's blood vessels is configured to constrict venous blood flow leading from the erectile tissue to facilitate anchoring of the erectile tissue.

[0925] In some embodiments, the implantable hydraulic constrictor comprises an implantable hydraulic constrictor for constricting a blood vessel of a patient.

[0926] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively emptying the patient's bladder.

[0927] In some embodiments, 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.

[0928] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable element for actively stretching the patient's stomach wall to induce a feeling of satiety. [Brief explanation of the drawings]

[0929] The above, as well as additional objects, features and advantages of the inventive concepts, will be better understood through the following illustrative and non-limiting detailed description of the inventive concepts, taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a cross-sectional view of an implantable energized medical device for hydraulically powering an implantable medical device. [Figure 2] FIG. 2 is an exploded cross-sectional view of an implantable energized medical device for hydraulically powering an implantable medical device. [Figure 3A] FIG. 3A is a detailed cross-sectional view of a first unit of an implantable energized medical device for hydraulically powering the implantable medical device. [Figure 3B] FIG. 3B is a detailed cross-sectional view of a first unit of an implantable energized medical device for hydraulically powering the implantable medical device. [Figure 3C] FIG. 3C is a detailed cross-sectional view of a first unit of an implantable energized medical device for hydraulically powering the implantable medical device. [Figure 3D] FIG. 3D is a detailed cross-sectional view of a first unit of an implantable energized medical device for hydraulically powering the implantable medical device. [Figure 4A]FIG. 4A shows an alternative embodiment of a connecting portion of an implantable energized medical device. [Figure 4B] FIG. 4B shows an alternative embodiment of a connecting portion of an implantable energized medical device. [Figure 5A] FIG. 5A shows an alternative embodiment of a connecting portion of an implantable energized medical device. [Figure 5B] FIG. 5B shows an alternative embodiment of a connecting portion of an implantable energized medical device. [Figure 6A] FIG. 6A shows an alternative embodiment of a connecting portion of an implantable energized medical device. [Figure 6B] FIG. 6B shows an alternative embodiment of a connecting portion of an implantable energized medical device. [Figure 7] FIG. 7 shows a schematic of a kit of parts for forming an implantable energized medical device. [Figure 8] FIG. 8 is a detailed cross-sectional view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 9] FIG. 9 is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 10] FIG. 10 is a right perspective elevation view of a portion of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 11] FIG. 11 is a right perspective elevation view of a portion of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 12A] FIG. 12A is a cross-sectional plan side view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 12B] FIG. 12B is a cross-sectional plan view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 12C] FIG. 12C is a cross-sectional plan side view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 12D]FIG. 12D is a cross-sectional plan side view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13A] FIG. 13A is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13B] FIG. 13B is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13C] FIG. 13C is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13D] FIG. 13D is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13E] FIG. 13E is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13F] FIG. 13F is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13G] FIG. 13G is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13H] FIG. 13H is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13I] FIG. 13I is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13J] FIG. 13J is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13K] FIG. 13K is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13M]FIG. 13M is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13N] FIG. 13N is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13P] FIG. 13P is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 13Q] FIG. 13Q is a right perspective elevation view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 14] FIG. 14 is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 15] FIG. 15 is a plan top view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 16] FIG. 16 shows a schematic top plan view of two embodiments of an implantable energized medical device for powering an implantable medical device. [Figure 17] FIG. 17 shows a schematic top plan view of two embodiments of an implantable energized medical device for powering an implantable medical device. [Figure 18A] FIG. 18A illustrates three stages of insertion and fixation of an embodiment of an implantable energized medical device for powering the implantable medical device. [Figure 18B] FIG. 18B illustrates three stages of insertion and fixation of an embodiment of an implantable energized medical device for powering the implantable medical device. [Figure 18C] FIG. 18C illustrates three stages of insertion and fixation of an embodiment of an implantable energized medical device for powering the implantable medical device. [Figure 19] FIG. 19 is a detailed cross-sectional view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 20A]FIG. 20A shows a schematic representation of a portion of an implantable energized medical device for powering the implantable medical device. [Figure 20B] FIG. 20B shows a schematic representation of a portion of an implantable energized medical device for powering the implantable medical device. [Figure 20C] FIG. 20C shows a schematic of a portion of an implantable energized medical device for powering the implantable medical device. [Figure 21A] FIG. 21A is a cross-sectional front view of a human patient when a remotely powered medical device for actively stretching the patient's stomach wall has been implanted. [Figure 21B] FIG. 21B is a cross-sectional front view of a human patient when a teleoperated medical device is implanted to affect the patient's urinary flow. [Figure 21C] FIG. 21C is a cross-sectional side view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 21D] FIG. 21D is a cross-sectional side view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 21E] FIG. 21E is a left, partially cutaway perspective view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 21F] FIG. 21F is a left, partially cutaway perspective view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 21G] FIG. 21G is a left, partially cutaway perspective view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 21H] FIG. 21H is a left, partially cutaway perspective view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 21I] FIG. 21I is a partial cross-sectional perspective view from the left showing one embodiment of a hydraulic pump for an implantable medical device. [Figure 21K] FIG. 21K is a partial cross-sectional perspective view from the left showing one embodiment of a hydraulic pump for an implantable medical device. [Figure 21M] FIG. 21M is a partial cross-sectional perspective view from the left showing one embodiment of a hydraulic pump for an implantable medical device. [Figure 21N] FIG. 21N is a left elevated perspective view of one embodiment of a hydraulic pump for an implantable medical device. [Figure 22A] FIG. 22A shows an embodiment and illustrates various features of an implantable control device for controlling an implantable contraction device. [Figure 22B] FIG. 22B shows an embodiment and illustrates various features of an implantable control device for controlling an implantable contraction device. [Figure 22B] FIG. 22B' shows an embodiment and illustrates various features of an implantable control device for controlling an implantable contraction device. [Figure 22C] FIG. 22C shows an embodiment and illustrates various features of an implantable control device for controlling an implantable contraction device. [Figure 22D] FIG. 22D shows an embodiment illustrating various features of an implantable control device for controlling an implantable contraction device. [Figure 22E] FIG. 22E shows an embodiment and illustrates various features of an implantable control device for controlling an implantable contraction device. [Figure 22F] FIG. 22F shows an embodiment illustrating various features of an implantable control device for controlling an implantable contraction device. [Figure 22G] FIG. 22G shows an embodiment illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22H] FIG. 22H shows an embodiment illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22I] FIG. 22I shows an embodiment, illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22K]FIG. 22K shows an embodiment illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22M] FIG. 22M shows an embodiment illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22N] FIG. 22N shows an embodiment illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22O] FIG. 22O shows an embodiment, illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22P] FIG. 22P shows an embodiment, illustrating various functions of an implantable control device for controlling an implantable medical device / implant and a communication system between different external devices. [Figure 22Q] FIG. 22Q is an elevational perspective view of the housing unit from the left side. [Figure 22R] FIG. 22R is a plan view of the housing as seen from the left. [Figure 22S] FIG. 22S is an elevational perspective view of the housing unit from the left side. [Figure 22T] FIG. 22T is a plan view of the housing as seen from the left. [Figure 22U] FIG. 22U shows a system overview of an external device that includes a housing unit and a display device that wirelessly communicates with an implantable medical device. [Figure 23A] FIG. 23A is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 23B] FIG. 23B shows a longitudinal cross section of the implantable medical device along line AA in FIG. 23a. [Figure 23C]FIG. 23C shows a longitudinal cross section of the implantable medical device along line AA in FIG. 23a. [Figure 24] FIG. 24 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 25] FIG. 25 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 26] FIG. 26 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 27A] FIG. 27A is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 27B] FIG. 27B shows a longitudinal cross section of the implantable medical device along line AA in FIG. 27a. [Figure 27C] FIG. 27C shows a longitudinal cross section of the implantable medical device along line AA in FIG. 27a.

[0930] The figures are not necessarily to scale and generally show only those parts necessary to clarify the inventive concept, with other parts omitted or merely suggested. DETAILED DESCRIPTION OF THE INVENTION

[0931] Hereinafter, a detailed description of embodiments of the present invention will be provided with reference to the accompanying drawings. It will be understood that the drawings are for illustrative purposes only and do not limit the scope of the present invention in any way. Accordingly, references to directions such as "up" and "down" merely refer to the directions shown in the drawings. It should be noted that features having the same reference numerals have the same functions, and therefore, a feature of one embodiment may be interchanged with a feature of another embodiment having the same reference numeral, unless there is a clear contradiction. Therefore, descriptions of features having the same reference numerals should be considered to complement each other in explaining the basic idea of ​​the feature, thereby demonstrating the versatility of the feature.

[0932] Different aspects or parts of aspects, or different embodiments or parts of embodiments, can all be combined in any possible way. Any method or any step of a method can also be viewed as a description of an apparatus, and similarly, any apparatus embodiment, aspect or part of an aspect, or part of an embodiment can be viewed as a description of a method, and all can be combined in any possible way, down to the smallest details. It should be noted that any detailed description should be interpreted in the broadest sense as a general overview description, and that any embodiment or part of an embodiment, and any method or part of a method, can be combined in any way. All examples in this specification should be considered part of the general description and, therefore, can be combined in any way in general terms.

[0933] It is important to note that although the implantable energized medical device is disclosed herein as having a third cross-sectional area that is smaller than the first cross-sectional area, this feature is not required. The third cross-sectional area may be equal to or greater than the first cross-sectional area.

[0934] 1 and 2 illustrate an embodiment of an implantable, energized medical device 140, which may be referred to elsewhere in this disclosure as a remote unit. The device 140 is configured to be held in place by a tissue portion 610 of a patient. The device 140 includes a first portion 141′ configured to be positioned on a first side 612 of the tissue portion 610, the first portion 141′ having a first cross-sectional area A1 in a first plane P1 and including a first surface 614 configured to face a first tissue surface 616 of the first side 612 of the tissue portion 610. The device 140 further comprises a second portion 141″ configured to be disposed on a second side 618 of the tissue portion 610, the second side 618 facing the first side 612, the second portion 141″ having a second cross-sectional area A2 in a second plane P2 and a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The device 140 further comprises a connecting portion 142 configured to be disposed through a hole in the tissue portion 610 extending between the first and second sides 612, 618 of the tissue portion 610. The connecting portion 142 here has a third cross-sectional area A3 in a third plane P3, a fourth cross-sectional area A4 in a fourth plane P4, and a third surface 624 configured to engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The connecting portion 142 is configured to connect the first portion 141' to the second portion 141''.

[0935] Thus, connecting portion 142 has a portion sized and shaped to fit through the hole in tissue portion 610, with such portion having a third cross-sectional area A3. Additionally, connecting portion 142 may have another portion sized and shaped not to fit through the hole in tissue portion 610, with such portion having a fourth cross-sectional area A4. Similarly, second portion 141'' may have a portion sized and shaped not to fit through the hole in tissue portion 610, with such portion having a second cross-sectional area A2. Thus, connecting portion 142 can cooperate with second portion 141'' to hold the device in place in the hole in tissue portion 610.

[0936] 1, first portion 141′ is configured to detachably, i.e., reversibly, connect to connecting portion 142 by a mechanical and / or magnetic mechanism. In the illustrated embodiment, a mechanical mechanism is used in which one or more spring-loaded spherical elements 601 are locked into position in grooves 603 in connecting portion 142 when first portion 141′ is inserted into connecting portion 142. Other locking mechanisms are also envisioned, such as corresponding threads or grooves, self-locking elements, twist-lock joints, etc.

[0937] When implanted, device 140 is configured such that first portion 141′ is positioned closer to the outside of the patient than second portion 141″. Furthermore, in some implantation procedures, device 140 may be implanted such that space is available beyond the second portion, i.e., beyond second side 618 of tissue portion 610, while less space is available on first side 612 of the tissue portion. Furthermore, tissue and / or skin may exert a force on first portion 141″ toward tissue portion 610, preventing second portion 141″ from migrating through holes in the tissue portion toward first side 612 of the tissue portion. Thus, it is preferred if device 140 is primarily configured to prevent first portion 141″ from migrating through holes in tissue portion 612 toward second side 618 of tissue portion 610.

[0938] The first portion 141′ may further include one or more connectors 605 for transmitting energy and / or communication signals to the second portion 141″ via the connecting portion 142. The connectors 605 in the illustrated embodiment are symmetrically arranged around the circumference of the protrusion 607 of the first portion 141′ and are positioned to engage with corresponding connectors 609 disposed on the inner surface of the connecting portion 142. The protrusion 607 may extend to the central extension C1 of the central portion 142. The second portion 141″ may also include one or several connectors 611, which may be positioned and configured similarly to the connectors 605 of the first portion 141′. For example, the one or several connectors 611 may engage with the connectors 609 of the connecting portion 142 to receive energy and / or communication signals from the first portion 141′. Although the protrusions 607 are illustrated separately in FIG. 1 , it should be understood that the protrusions 607 may be integrally formed with the first portion 141′.

[0939] Other arrangements of the connectors are also contemplated, such as connectors arranged asymmetrically around the circumference of the protrusion 607. It is also contemplated that one or several connectors may be arranged on the first surface 614 of the first portion 141′, arranged to engage with corresponding connectors arranged on the opposing surface 613 of the connector. Such connectors on the opposing surface 613 may cover a relatively larger area compared to the connector 609, thus enabling a larger contact area and a higher speed and / or signal strength of the transmission of energy and / or communication signals. Furthermore, it is contemplated that the physical connection between the first portion 141′, the connecting portion 142, and the second portion 141″ may be replaced by or involve a wireless arrangement, as further described elsewhere in this disclosure.

[0940] Any of the first surface 614 of the first portion 141′, the second surface 620 of the second portion 141′, the third surface 624 of the connecting portion 142, and the opposing surface 613 of the connecting portion 142 may include at least one of ribs, barbs, hooks, friction-enhancing surface treatments, and friction-enhancing materials to facilitate the device 140 being held in place by tissue portions and / or to facilitate the different portions of the device being held in place relative to each other.

[0941] The opposing surface 613 of connecting portion 142 and the first surface 614 of first portion 141′ can provide, in whole or in part, a connection mechanism for removably connecting first portion 141′ to connecting portion 142. Such connection mechanisms have been described earlier in this disclosure, can be located on one or both of opposing surface 613 and first surface 614, and will not be described further here.

[0942] The facing surface 613 may comprise a recess configured to accommodate at least a portion of the first portion 141′. In particular, such recess may be configured to receive at least a portion of the first portion 141′, including the first surface 614. Similarly, the first surface 614 may comprise a recess configured to accommodate at least a portion of the connecting portion 142. In particular, such recess may be configured to receive at least a portion of the connecting portion 142, and in some embodiments, such recess may be configured to receive at least one protruding element to at least partially surround at least one protruding element or flange.

[0943] In the illustrated embodiment, the first portion 141′ comprises a first energy storage unit 304a and a controller 300a comprising one or more processing units connected to the first energy storage unit 304a. The first energy storage unit 304a may be rechargeable via wireless energy transfer. In some embodiments, the first energy storage unit 304a may be non-rechargeable. Upon expiration of such a first energy storage life, a replacement first portion including a new first energy storage unit may simply be swapped in place of the first portion having the worn-out first energy storage unit. The second portion 141″ may further comprise a controller 300b comprising one or more processing units.

[0944] As described elsewhere in this disclosure, the first portion 141′ and the second portion 141″ may be comprised of one or more functional portions such as a receiver, a transmitter, a transceiver, a control unit, a processing unit, a sensor, an energy storage unit, a sensor, etc.

[0945] The device 140 may be non-inflatable.

[0946] While second portion 141'' in the illustrated embodiment comprises a pump, as described in conjunction with Figures 22c-22n, it should be understood that other embodiments of second portion 141'' can be connected to first portion 141' via connecting portion 142, such as second portion 141'' comprising a motor for providing mechanical work without the use of a fluid. Furthermore, although connecting portion 142 is illustrated in Figure 1 as a separate unit, connecting portion 142 may form part of second portion 141''.

[0947] The first portion 141' may be removably coupled to at least one of the coupling portion 142 and the second portion 141''.

[0948] As can be seen in FIG. 2 , the first, second, third, and fourth planes P1, P2, P3, and P4 are parallel to one another. Furthermore, in the illustrated embodiment, the third cross-sectional area A3 is smaller than the first cross-sectional area A1, the second cross-sectional area A2, and the fourth cross-sectional area A4, such that the first portion 141′, the second portion 141″, and the connecting portion 142 are prevented from moving through the holes in the tissue portion 610 in directions perpendicular to the first plane P1, the second plane P2, and the third plane P3. This allows the second portion 141″ and the connecting portion 142 to be held in place by the patient's tissue portion 610 even when the first portion 141′ is separated from the connecting portion 142.

[0949] It should be understood that the illustrated planes P1, P2, P3, and P4 are merely examples of how such planes may intersect the device 140. Other arrangements of planes are possible as long as the above conditions are met, i.e., the portion has a cross-sectional area, the third cross-sectional area in the third plane P3 is smaller than the first, second, and fourth cross-sectional areas, and the planes P1, P2, P3, and P4 are parallel to one another.

[0950] 2 can be defined as a connecting portion 142 including a flange 626. The flange 626 thus defines a fourth cross-sectional area A4 such that the flange 626 is prevented from moving through the hole in the tissue portion 610 in a direction perpendicular to the first, second, and third planes P1, P2, and P3. The flange 626 may protrude in a direction parallel to the first, second, third, and fourth planes P1, P2, P3, and P4. This direction is perpendicular to the central extension C1 of the connecting portion 142.

[0951] However, the connecting portion 142 is not limited to a flange. Other protruding elements may additionally or alternatively be incorporated into the connecting portion 142. Thus, the connecting portion 142 may include at least one protruding element defining a fourth cross-sectional area A4, and such at least one protruding element is prevented from moving through a hole in the tissue portion 610 so that the second portion 141″ and the connecting portion 142 can be held in place by the patient's tissue portion 610 even when the first portion 141′ is detached from the connecting portion 142. The at least one protruding element may protrude in a direction parallel to the first, second, third, and fourth planes P1, P2, P3, and P4. This direction is perpendicular to the central extension C1 of the connecting portion 142. Thus, the at least one protruding element also defines a third surface configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.

[0952] The connecting portion 142 may include a hollow portion 628. The hollow portion 628 may provide a passageway between the first and second portions 141′, 141″. In particular, the hollow portion 628 may accommodate a conduit for transferring a fluid from the first portion 141′ to the second portion 141″. The hollow portion 628 may also define or accommodate one or several connections or electrical leads for transmitting energy and / or communication signals between the first portion 141′ and the second portion 141″.

[0953] Some relative dimensions of device 140 will now be described with reference to Figures 2 and 3A-3D, although it should be understood that these dimensions may also apply to other embodiments of device 140. At least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane that is less than a height H1 of first portion 141' in said direction. Height HF may alternatively be less than half of height H1 of first portion 141' in said direction, less than a quarter of height H1 of first portion 141' in said direction, or less than a tenth of height H1 of first portion 141' in said direction.

[0954] The height H1 of the first portion 141' in a direction perpendicular to the first plane may be smaller than the height H2 of the second portion 141'' in said direction, for example, less than half the height H2 of the second portion 141'' in said direction, less than a quarter of the height H2 of the second portion 141'' in said direction, or less than a tenth of the height H2 of the second portion 141'' in said direction.

[0955] At least one protruding element 626 may have a diameter DF in the fourth plane that is one of: smaller than diameter D1 of first portion 141′ in the first plane, equal to diameter D1 of first portion 141′ in the first plane, and larger than diameter D1 of first portion 141′ in the first plane. Similarly, the cross-sectional area of ​​at least one protruding element 626 in the fourth plane may be smaller than, equal to, or larger than the cross-sectional area of ​​the first portion in the first plane.

[0956] At least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane that is smaller than a height HC of the connecting portion 142 in said direction, where the height HC of the connecting portion 142 is defined as the height excluding the at least one protruding element that forms part of the connecting portion 142. The height HF may alternatively be less than half the height HC of the connecting portion 142 in said direction, less than one-quarter the height HC of the connecting portion 142 in said direction, or less than one-tenth the height HC of the connecting portion 142 in said direction.

[0957] As shown in FIG. 3D , first portion 141′ can have a first cross-sectional area A1 that is equal to or less than third cross-sectional area A3 of connecting portion 142. In particular, first portion 141′ does not necessarily provide a cross-sectional area greater than the third cross-sectional area of ​​connecting portion 142 that is intended to pass through a tissue hole, provided that connecting portion 142 provides an additional cross-sectional area greater than the third cross-sectional area of ​​connecting portion 142. First portion 141′ as illustrated in FIG. 3D can be comprised of components not shown but discussed elsewhere in this disclosure, such as an energy storage unit, a receiver, a transmitter, etc.

[0958] As shown in Figures 4A-4B, the at least one protruding element 626 can have an annular shape, such as a disk shape. However, elliptical, elongated, and / or other polyhedral or irregular shapes are also possible. In the illustrated embodiment, the at least one protruding element 626 extends one revolution around the central axis of the connecting portion 142. However, other arrangements are possible in which the at least one protruding element 626 forms a partial circular sector. In the case of multiple protruding elements, such multiple protruding elements may form multiple partial circular sectors.

[0959] 5A-5B and 6A-6B, the connecting portion 142 may be comprised of at least two protruding elements 626, 627. For example, the connecting portion 142 may be comprised of at least three, four, five, six, seven, eight, nine, or ten protruding elements. In such embodiments, the at least two protruding elements 626, 627 may together define a fourth cross-sectional area, thus providing the cross-sectional area necessary to prevent the first and second portions from migrating through a hole in the tissue portion.

[0960] The at least two protruding elements 626, 627 may be symmetrically positioned about the central axis of the connecting portion, as shown in Figures 5A-5B, or asymmetrically positioned about the central axis of the connecting portion, as shown in Figures 6A-6B. In particular, the at least two protruding elements 626, 627 may be asymmetrically positioned toward one side of the connecting portion 142, as shown in Figures 6A-6B. The positioning of the protruding elements may enable the device 140, and in particular the connecting portion 142, to be positioned in an area of ​​the patient where space is limited in one or more directions.

[0961] The first portion 141 ′ may constitute a first energy storage device for supplying energy to the device 140 .

[0962] While one type or embodiment of the implantable energized medical device 140, which may be referred to elsewhere in this disclosure as a remote unit, may fit most patients, it may be necessary to provide a selection of implantable energized medical devices 140 or parts that assemble into the implantable energized medical device 140. For example, some patients may require different lengths, shapes, sizes, widths, or heights depending on their individual anatomy. Furthermore, while some parts or parts of the implantable energized medical device 140 may be common among several different types or embodiments of the implantable energized medical device, other parts or parts may be interchangeable or replaceable. Such parts or parts may include energy storage devices, communication devices, fluid connections, mechanical connections, electrical connections, etc.

[0963] To provide flexibility and ease of use, a kit of parts may be provided. The kit preferably comprises one or more groups of first parts, one or more groups of second parts, and one or more groups of connecting parts, wherein the first parts, second parts, and connecting parts are embodied as described throughout this disclosure. At least one of the groups comprises at least two different types of said respective parts. By the term "type" herein is meant a variety, class, or embodiment of said respective parts.

[0964] In some embodiments of the kit, one or more groups of first portions, one or more groups of second portions, and one or more groups of connecting portions constitute separate parts that can be assembled into a complete implantable energized medical device. Thus, the implantable energized medical device can be said to be modular in that the first portions, second portions, and / or connecting portions are interchangeable with other types of respective portions.

[0965] In some embodiments, the linking moiety forms part of the first portion or the second portion.

[0966] 7, a kit for assembling an implantable energized medical device includes one or more groups 650 of first portions 141′, in the illustrated example one group of first portions 141′, one or more groups 652 of connecting portions 142, in the illustrated example three groups of connecting portions 142, and one or more groups 654 of second portions 141″, in the illustrated example two groups of second portions 141″. For simplicity, not all types and combinations of first portions, second portions and connecting portions are shown or described in detail.

[0967] Thus, a group 652 of one or more linking portions 142 is composed of three different types of linking portions 142, where the different types of linking portions 142 include linking portions 142a, 142b, and 142c having different heights. Furthermore, a group 654 of one or more second portions 141'' includes two different types of second portions 141''.

[0968] Here, a different type of second portion 141'' includes a second portion 141''a configured to extrapolately connect to a connecting portion, as described elsewhere in this disclosure, having a first end and a second end, the second end of second portion 141''a comprising or configured to comprise at least one connection for connecting to an implant located caudally from the location of the implantable, energized medical device in the patient when the device is assembled. In the illustration, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including those in which the second end comprises a port, connector, or other type of connection element for power, fluid, and / or signal transmission.

[0969] Additionally, a different type of second portion 141'' may include a second portion 141''b having a first end and a second end configured to connect extrapolatively to a connecting portion, as described elsewhere in this disclosure, the first end of the second portion 141''b including or configured to connect to an implant located cranially from the location of the implantable, energized medical device in the patient when the device is assembled. In the illustrations, the at least one connecting portion is visualized as a lead or wire. However, other embodiments are possible, including those in which the first end is comprised of a port, connector, or other type of connecting element for power, fluid, and / or signal transmission.

[0970] Thus, the implantable energized medical device may be modular, and different types of devices may be realized by selecting and combining first portion 141′, connecting portion 142, and second portion 141″ from each of groups 652, 654, 656.

[0971] In the illustrated embodiment, a first implantable, energized medical device 140a is realized by selecting a first portion 141′, a connecting portion 142a, and a second portion 141″a. Such a device 140a may be particularly advantageous in that connecting portion 142a may extend through thick layers of tissue to connect first portion 141′ and second portion 141″a. Another implantable, energized medical device 140b is realized by selecting a first portion 141′, a connecting portion 142c, and a second portion 141″b. Such a device may be particularly advantageous in that connecting portion 142c has a smaller footprint, i.e., takes up less space within the patient, than connecting portion 142a. The modular nature of devices 140a and 140b allows a practitioner or surgeon to evaluate a patient's anatomy and select the appropriate connecting portion as needed. Furthermore, because devices 140a and 140b share a common type of first portion 141', it is not necessary for a practitioner or surgeon to maintain an inventory of different first portions (or an inventory of complete assembled devices) simply to achieve devices having different connections located at the first or second ends of the second portions, as is the case with second portions 141''a, 141''b, respectively.

[0972] The example shown in FIG. 7 is merely illustrative to illustrate the idea of ​​a modular implantable, energized medical device 140. The group 650 of one or more first portions 141′ may include a variety of different features, such as first portions with or without a first energy storage unit, first portions with or without a first wireless energy receiving unit for receiving energy wirelessly transmitted by an external wireless energy transmitter, first portions with or without an internal wireless energy transmitter, and / or other features as described throughout this disclosure. Other features include different heights, widths, or lengths of the first portions. It should be understood that first portions having one or more of these features can be combined with specific shapes or dimensions to achieve various first portions. The same applies to the connecting portion and second portion.

[0973] 8, an embodiment of an implantable, energized medical device 140, sometimes referred to elsewhere in this disclosure as a remote unit, is described. The device 140 is configured to be held in place by a patient's tissue portion 610. The device 140 includes a first portion 141′ configured to be positioned on a first side of the tissue portion 610, the first portion 141′ having a first cross-sectional area in a first plane and including a first surface configured to face and / or engage a first tissue surface on the first side of the tissue portion 610. The device 140 further includes a second portion 141″ configured to be positioned on a second side of the tissue portion 610, the second side facing the first side, the second portion 141″ 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 610. The device 140 further includes a connecting portion 142 configured to be disposed through a hole in the tissue portion 610 extending between the first and second sides of the tissue portion 610. Here, the connecting portion 142 has a third cross-sectional area in a third plane. The connecting portion 142 is configured to connect the first portion 141′ to the second portion 141″. Here, the first portion 141′ includes a first wireless energy receiver 308a for receiving energy wirelessly transmitted by an external wireless energy transmitter, and an internal wireless energy transmitter 308a configured to wirelessly transmit energy to the second portion. Furthermore, here, the second portion includes a second wireless energy receiver 308b configured to receive energy wirelessly transmitted by the internal wireless energy transmitter 308a.

[0974] While the receiver and transmitter are sometimes discussed and illustrated separately in this disclosure, it should be understood that the receiver and / or transmitter may be configured within a transceiver. Furthermore, the receiver and / or transmitter of each of the first and second portions 141′ and 141″ may form part of a single receiving or transmitting unit configured to receive or transmit energy signals and / or communication signals including data. Furthermore, the internal wireless energy transmitter and / or first wireless communication receiver / transmitter may be a separate unit 308c located in a lower portion of the first portion 141′, near the connecting portion 142 and the second portion 141″, referred to elsewhere in this disclosure as the proximal end of the first portion 141′. Such an arrangement may provide that the energy and / or communication signals transmitted by unit 308c are not attenuated by internal components of the first portion 141′ when transmitted to the second portion 141″. Such internal components may include the first energy storage unit 304a.

[0975] Here, the first portion 141' comprises a first energy storage unit 304a connected to a first wireless energy receiver 308a. The second portion comprises a second energy storage unit 304b connected to a second wireless energy receiver 308b. Such energy storage units may be solid-state batteries, such as thionyl chloride batteries.

[0976] In some embodiments, the first wireless energy receiver 308a is configured to receive energy wirelessly transmitted by an external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the internal wireless energy transmitter 308a is configured to wirelessly transmit the energy stored in the first energy storage unit 304a to the second wireless energy receiver 308b, and the second wireless energy receiver 308b is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter 308a and store the received energy in the second energy storage unit 305b.

[0977] The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b and / or may be configured to charge faster than the second energy storage unit 304b. This allows the first energy storage unit 304a to charge relatively quickly, while energy transfer from the first energy storage unit 304a to the second energy storage unit 304b occurs relatively slowly. Thus, a user can quickly charge the first energy storage unit 304a without being restricted for a long period of time during such charging, for example, by being connected to an external wireless energy transmitter in a particular location. After charging the first energy storage unit 304a, the user can move freely while energy is slowly transferred from the first energy storage unit 304a to the second energy storage unit 304b via the first wireless energy transmitters 308a,c and the second wireless energy receiver 308b.

[0978] The first part may comprise a first controller including at least one processing unit 306 a. The second part may comprise a second controller including at least one processing unit 306 b. At least one of the first and second processing units 306 a, 306 b may be connected to a wireless transceiver 308 a, b, c for wireless communication with external devices.

[0979] The first control device may be connected to the first wireless communication receiver 308a,c in the first portion 141′ to receive wireless communications from an external device and / or from the wireless communication transmitter 308b in the second portion 141″. Further, the first control device may be connected to the first wireless communication transmitter 308a,c in the first portion 141′ to transmit wireless communications to the second wireless communication receiver 308b in the second portion 141″. The second control device may be connected to the second wireless communication receiver 308b to receive wireless communications from the first portion 141′. The second control device may further be connected to the second wireless communication transmitter 308b to transmit wireless communications to the first portion 141′.

[0980] In some embodiments, as shown in FIG. 19, the first wireless energy receiver 308a comprises a first coil and the wireless energy transmitter 308a,c comprises a second coil.

[0981] The device may further include at least one sensor (not shown) for providing input to at least one of the first and second controllers. Such sensor data may be transmitted to an external device via the first wireless communication transmitter 308a and / or the second wireless communication transmitter 308b. The sensor may be or consist of a sensor configured to sense a physical parameter of the device 140. The sensor may also be or consist of a sensor configured to sense at least one of the following: the temperature of the device 140, the temperature of the body-engaging portion, a parameter related to the power consumption of the device, a parameter related to the power consumption of the body-engaging portion, a parameter related to a condition such as the health status of at least one of the first and second energy storage units 304a, 304b, a parameter related to the wireless transfer of energy from a source external to the patient's body, and hydraulic pressure. The term "health status" refers to a condition indicative of the current total capacity of the energy storage units compared to the total capacity of unused energy storage units. The sensor may also be or consist of a sensor configured to sense at least one of a patient's physiological parameters, such as 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, or pH. The sensor configured to sense a parameter related to the patient's swallowing may consist of at least one of a motility sensor, an acoustic sensor, an optical sensor, and a strain sensor. The sensor configured to sense pH may be configured to sense acidity in the stomach.

[0982] The sensors may be configured to sense the temperature of the device 140 to avoid excessive heating of tissue connected to the device during operation of the device, or during operation of an external implant using the device, or during charging of an energy storage unit within the device 140. Excessive heating may also damage the device and / or the energy storage unit. Excessive heating may also be an indicator that there is a malfunction in the device and may be used to trigger an alarm function to alert the patient or physician. The sensors may also be configured to sense parameters related to the power consumption of the device 140 or the power consumption of an external implant powered by the device 140 to avoid excessive power consumption that may deplete and / or damage the energy storage unit of the device 140. Excessive power consumption may also be an indicator that there is a malfunction in the device 140 and may be used to trigger an alarm function to alert the patient or physician.

[0983] The wireless energy receiver and / or communication receiver and / or transmitter in the first portion 141′ may be configured to receive energy from and / or wirelessly communicate with an external device outside the body using electromagnetic waves at frequencies below 100 kHz, more specifically below 40 kHz, and more specifically below 20 kHz. Thus, the wireless energy receiver and / or communication receiver and / or transmitter in the first portion 141′ may be configured to communicate with an external device using “very low frequency” (VLF) communications. VLF signals have the ability to penetrate the titanium housing of the implantable, energized medical device, allowing the electronics of the implantable, energized medical device to be fully encapsulated within the titanium housing. Additionally or alternatively, communication and energy transfer between the first portion 141′ and the second portion 141″ may be performed using VLF signals. In such an embodiment, the receivers and transmitters (for energy and / or communications) of the first portion 141′ and the second portion 141″ are configured accordingly.

[0984] 9, 12A, and 12B, an embodiment of an implantable, energized medic...

Claims

1. 1. An implantable, energized medical device configured to be held in place by a tissue portion of a patient, the medical device comprising: a first portion configured to be disposed on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and including a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be disposed on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and including a second surface configured to engage a second tissue surface on the second side of the tissue portion; a connecting portion configured to be disposed through a hole in the tissue portion extending between the first side and the second side of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion; the first plane, the second plane, and the third plane are parallel to each other; the third cross-sectional area is smaller than the first and second cross-sectional areas to prevent movement of the first and second portions through a hole in the tissue portion in a direction perpendicular to the first, second, and third planes; the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter, and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion; The implantable energized medical device, wherein the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter.

2. 10. The implantable energized medical device of claim 1, wherein the first portion comprises a first energy storage unit connected to the first wireless energy receiver.

3. 3. The implantable energized medical device of claim 2, wherein the second portion comprises a second energy storage unit connected to the second wireless energy receiver.

4. The implantable energized medical device of claim 3 , wherein at least one of the first and second energy storage units is a solid-state battery.

5. The implantable energized medical device of claim 4 , wherein the solid-state battery is a thionyl chloride battery.

6. 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 energy stored in the first energy storage unit to the second wireless energy receiver; The implantable energized medical device of any one of claims 3 to 5, wherein the second wireless energy receiver is configured to receive energy wirelessly transmitted by an internal wireless energy transmitter and store the received energy in the second energy storage unit.

7. 10. The implantable, energized medical device of claim 1, wherein the first portion comprises a first control device including at least one processing unit.

8. 8. The implantable energized medical device of claim 7, wherein the second portion comprises a second controller including at least one processing unit.

9. 9. The implantable energized medical device of claim 8, wherein at least one of the first and second control devices is connected to a wireless transceiver for wireless communication with an external device.

10. the first control device is connected in the first portion to a first wireless communication receiver for receiving wireless communication from an external device; 9. The implantable energized medical device of claim 8, wherein the first control device is connected to a first wireless communication transmitter of the first portion for transmitting wireless communications to a second wireless communication receiver of the second portion.

11. 11. The implantable energized medical device of claim 10, wherein the second control unit is connected to the second wireless communication receiver for receiving wireless communication from the first portion.

12. 10. The implantable energized medical device of claim 1, wherein the first wireless energy receiver comprises a first coil and the second wireless energy receiver comprises a second coil.

13. 10. The implantable energized medical device of claim 1, wherein the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to the second wireless energy receiver in the second portion.

14. 14. The implantable energized medical device of claim 12, wherein at least one of the coils is embedded in a ceramic material.

15. 6. The implantable, energized medical device of claim 1, further comprising 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.

16. 16. An implantable energized medical device as defined in claim 15, wherein the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

17. The implantable, energized medical device of any one of claims 1 to 5, further comprising a housing configured to surround at least the second portion, wherein a first portion of the housing is made from titanium and a second portion of the housing is made from a ceramic material.

18. 20. The implantable energized medical device of claim 17, wherein the portion of the housing made from a ceramic material comprises at least one coil embedded in the ceramic material.

19. The implantable energized medical device of any one of claims 1 to 5, wherein the first portion is detachably coupled to at least one of the second portion and the coupling portion.

20. 6. An implantable, electrically-operated medical device according to any one of claims 1 to 5, wherein the connecting portion comprises a flange having a flange area greater than the cross-sectional area of ​​the hole in the tissue portion, such that the flange is prevented from moving through the hole in the tissue portion and the second portion and the connecting portion can be held in place by the patient's tissue portion when the first portion is separated from the connecting portion.

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