WO2023031053A1

WO2023031053A1 - Treatment of hypertension

Info

Publication number: WO2023031053A1
Application number: PCT/EP2022/073830
Authority: WO
Inventors: Peter Forsell
Original assignee: Implantica Patent Ltd
Priority date: 2021-08-30
Filing date: 2022-08-26
Publication date: 2023-03-09
Also published as: WO2023031056A1; CA3233737A1; AU2022340840A1

Abstract

A system for treating a patient with hypertension is disclosed, comprising a stimulation device comprising a first electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patient to affect a vasomotor tone of a smooth muscle tissue of the renal artery, a signal damping device comprising a second electrode arrangement configured to deliver an electric damping signal to tissue of the patient, and a control unit operably connected to the stimulation device and to the signal damping device, wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery, and to control an operation of the signal damping device to damp or disturb the electric stimulation signal delivered by the stimulation device.

Description

TREATMENT OF HYPERTENSION

Technical field

The present disclosure relates to a technology for treating patients suffering from hypertension, and more specifically to systems and methods for causing electrically induced vasodilation of the renal artery.

Background

Hypertension, commonly referred to as ‘high blood pressure’ is a medical condition in which the blood pressure is persistently elevated. In most people suffering from hypertension, increased resistance to blood flow accounts for the high pressure while cardiac output remains normal. The increased resistance that must be overcome to push blood through the circulatory system and create flow is sometimes referred to as vascular resistance or systemic vascular resistance. There are many factors that are known to alter the vascular resistance. Vascular compliance is determined by the muscle tone in the smooth muscle tissue of the tunica media and the elasticity of the elastic fibers there. However, the muscle tone is subject to continual homeostatic changes by hormones and cell signaling molecules that induce vasodilation and vasoconstriction to keep blood pressure and blood flow within reference ranges.

Hypertension has been identified as an important preventable risk factor for premature death worldwide. It increases the risk of ischemic heart disease, strokes, peripheral vascular disease, and other cardiovascular diseases, including heart failure, aortic aneurysms, and chronic kidney disease.

Hypertension is commonly treated by antihypertensive agents such as beta blockers, angiotensin receptor blockers and renin inhibitors, as well as by lifestyle changes including weight loss, physical exercise, decreased salt intake and a healthy diet.

However, due to the ever-growing part of the population suffering from hypertension, there is a need for improved and alternative treatments.

Summary

It is an object of the present invention to provide improved technologies and methods for treating hypertension. This is achieved by the subject-matter defined in the independent claims. Advantageous embodiments are defined in the dependent claims.

According to an embodiment, a system for treating a patient with hypertension is provided, comprising a stimulation device comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patent to affect a vasomotor tone of a smooth muscle tissue of the renal artery, an implantable source of energy configured to energize the electrode arrangement, and a control unit operably connected to the stimulation device. The control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery.

According to an embodiment, a medical device is provided, comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patient to affect a vasomotor tone of a smooth muscle tissue of the renal artery, and a remote unit operably connected to the electrode arrangement and configured to generate the electric stimulation signal such that the electric stimulation signal causes vasodilation of the renal artery. The remote unit is configured to be secured to a tissue wall of the patient, and comprises a first unit configured to be implanted at a first side of the tissue wall of the patient, a second unit configured to be implanted at a second side of the tissue wall, and a connecting unit configured to be arranged to extend through the tissue wall and to be mechanically attached to the first unit and the second unit. The first unit and the second unit are provided with a shape and size hindering them from passing through the tissue wall.

According to an embodiment, a system for treating a patient suffering from hypertension is provided. The system comprises a stimulation device comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patient to affect a vasomotor tone of a smooth muscle tissue of the renal artery, an implantable sensor configured to generate a signal indicative of a blood pressure of the patient, and a control unit communicatively connected to the stimulation device and to the sensor device. The control unit is configured to control an operation of the stimulation device, based on the signal generated by the sensor device, such that the electric stimulation signal causes vasodilation of the renal artery.

In an example, the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or a nerve innervating the renal artery.

In an example, the electrode arrangement is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

In an example, the support structure comprises a cuff portion configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

In an example, the electrode arrangement is arranged on an inner surface of the cuff.

In an example, the electrode arrangement is configured to electrically stimulate a sacral nerve. In an example, the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

In an example, the electrical stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

In an example, the electrical stimulation signal comprises a pulse width of 0.01-1 ms.

In an example, the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.

In an example, the system further comprises a signal damping device configured to be arranged at the parasympathetic nerve, at a position between the stimulation device and the spinal cord.

In an example, the signal damping device comprises an electrode arrangement configured to deliver an electric damping signal to the parasympathetic nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal generated by the stimulation device.

In an example, the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal.

In an example, the control unit is configured to be communicatively connected to a wireless remote control.

In an example, the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

In an example, the sensor comprises a pressure sensor configured to be arranged in a blood vessel of the patient.

In an example, the sensor is configured to be arranged at an outer wall of a blood vessel of the patient.

In an example, the sensor is configured to measure a pressure pulse wave transmitted from the blood flow to the outer wall of the blood vessel.

In an example, the sensor comprises a strain gauge sensitive to strain in the outer wall of the blood vessel.

In an example, the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the blood vessel and the pressure sensor.

In an example, the sensor comprises a doppler radar sensor configured to measure the blood pressure in the blood vessel.

In an example, the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor. In an example, the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.

In an example, the sensor is a flow sensor configured to generate a signal indicative of a flow through a blood vessel

In an example, the system further comprises a blood pressure sensor configured to generate a signal indicating a blood pressure of the patient.

In an example, the blood pressure sensor is configured to determine a local blood pressure in the renal artery.

In an example, blood pressure sensor is configured to determine a systemic blood pressure.

In an example, the control unit is configured to receive the signal generated by the blood pressure sensor.

In an example, the control unit is configured to control the operation of the stimulation device based on the received signal.

In an example, the control unit is configured to determine an estimated blood pressure based the on signal generated by the sensor, wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

In an example, the control unit is configured to compare the estimated blood pressure with a predetermined limit value, and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery, and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery.

In an example, the control unit is configured to monitor, over time, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking over time, control the operation of the stimulation device to cause vasoconstriction of the renal artery, and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

In an example, the first unit has a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the first side of the tissue portion, the second unit has a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the second side of the tissue portion, the connecting unit has a third cross-sectional area in a third plane, and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first unit and the second unit are prevented from travelling through the tissue wall.

In an example, the connecting unit has a circular cross-section.

In an example, the connecting unit is hollow.

In an example, at least one of the first and second units is configured to be threaded onto the connecting unit.

In an example, the first and second unit forms a bolted joint with the connecting unit.

In an example, the connecting unit is elastic.

In an example, the signal damping device is arranged in at least one of the first unit, second unit and the connecting unit.

In an example, the sensor is arranged in at least one of the first unit, the second unit and the connecting unit.

In an example, the source of energy is arranged in at least one of the first unit, the second unit and the connecting unit.

In an example, at least one of the first unit, the second unit and the connecting unit comprises a wireless receiver configured to receive energy transmitted from outside the body of the patient.

In an example, at least one of the first unit, the second unit and the connecting unit comprises a wireless transceiver for communicating wirelessly with an external device.

In an example, the remote unit is configured to be implanted in a tissue wall forming part of at least one of: the diaphragm, the left or right crus, the medial or lateral arcuate ligament, the psoas major, the quadratus lumborum, the transverse abdominal wall, the psoas minor, the internal oblique abdominal wall, the iliacus, and the psoas major.

According to an embodiment, a system for treating a patient with hypertension is provided, comprising a stimulation device comprising a first electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patient to affect a vasomotor tone of a smooth muscle tissue of the renal artery, a signal damping device comprising a second electrode arrangement configured to deliver an electric damping signal to tissue of the patient, and a control unit operably connected to the stimulation device and to the signal damping device. The control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery, and to control an operation of the signal damping device to damp or disturb the electric stimulation signal delivered by the stimulation device.

In an example, the second electrode arrangement is configured to deliver the electric damping signal to a nerve innervating the renal artery to damp or reduce transmission of the electric stimulation signal in the nerve.

In an example, the second electrode arrangement is configured to deliver the electric damping signal at a position between the first electrode arrangement and a spinal cord of the patient.

In an example, at least one of the first and second electrode arrangements comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or a nerve innervating the renal artery.

In an example, at least one of the first and second electrode arrangements is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on a nerve innervating the renal artery.

In an example, the support structure comprises a cuff configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

In an example, at least one of the first and second electrode arrangements is arranged on an inner surface of the cuff.

In an example, each of the stimulation device and the signal damping device is configured to deliver an electric stimulation signal and an electric damping signal, respectively, to a parasympathetic nerve.

In an example, the control unit is configured to generate a pulsed electric stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

In an example, the electric stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

In an example, the electric stimulation signal comprises a pulse width of 0.01-1 ms.

In an example, the electric stimulation signal comprises a pulse amplitude of 1-15 mA.

In an example, the control unit if configured to generate the electric damping signal based on the electric stimulation signal.

In an example, the electric damping signal is out of phase with the electric stimulation signal. In an example, the electric stimulation signal and the electric damping signal are pulsed signals, and wherein a frequency of the electric damping signal is higher than a frequency of the electric stimulation signal.

In an example, the frequency of the electric damping signal is at least twice the frequency of the electric stimulation signal.

In an example, the signal damping device is configured to deliver an electric scrambling signal for disturbing the electric stimulation signal passing the signal damping device.

In an example, the system further comprises a signal processing means configured to measure the electric stimulation signal received at the signal damping device and to generate the electric damping signal based on the received electric stimulation signal.

In an example, the system further comprises a source of energy for energising the first and/or second electrode arrangements.

In an example, the source of energy is configured to be implanted subcutaneously.

In an example, the source of energy comprises at least one of a primary cell and a secondary cell.

In an example, the control unit is configured to indicate a functional status of the source of energy.

In an example, the functional status indicates a charge level of the source of energy.

In an example, the control unit is configured to indicate a temperature of at least one of the source of energy, the nerve and tissue adjacent to the nerve.

In an example, the system according to any of the above embodiments may further comprise a coating arranged on at least one surface of at least one of the stimulation device, the damping device, and the control unit.

In an example, the coating comprises at least one layer of a biomaterial.

In an example, the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

In an example, the biomaterial is fibrin-based.

In an example, the system further comprises a second coating arranged on the first coating.

In an example, the second coating is a different biomaterial than said first coating.

In an example, the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer. In an example, the coating comprises a drug encapsulated in a porous material.

In an example, the surface comprises a metal.

In an example, the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.

In an example, the surface comprises a micropattem.

In an example, the micropattem is etched into the surface prior to insertion into the body.

In an example, the system further comprises a layer of a biomaterial coated on the micropattem.

According to an embodiment, a system for treating a patient with hypertension is provided, comprising a stimulation device comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patent to affect a vasomotor tone of a smooth muscle tissue of the renal artery. The system further comprises an implantable energy receiver configured to energize the electrode arrangement, an energy source configured to transfer energy wirelessly to the energy receiver, and a control unit operably connected to the stimulation device. The control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery.

In an example, the energy source is configured to be implanted in the patient.

In an example, the energy source is configured to be charged by energy transferred wirelessly from outside the body of the patient.

The system according to any of the preceding claims, wherein the control unit is configured to generate control instmctions for controlling the operation of the stimulation device, and to transmit the control instructions wirelessly from outside of the body of the patient to the stimulation device.

According to an embodiment, a system for treating a patient with hypertension is provided, comprising a stimulation device comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patent to affect a vasomotor tone of a smooth muscle tissue of the renal artery. The system further comprises a source of energy configured to energize the electrode arrangement, and a control unit operably connected to the stimulation device. The control unit is configured to generate control instructions for controlling the operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery and transmit the control instructions wirelessly to the stimulation device.

In an example, the control unit comprises an external part configured to be arranged outside the body of the patient and an internal part configured to be implanted in the patient, and wherein the internal and external parts are configured to communicate wirelessly with each other.

In an example, the internal and external parts are configured to communicate with each other by means of radiofrequency signals or inductive signals. According to an embodiment, a communication system for enabling communication between a display device and a system according to any of the above embodiments is provided. The communication system comprises a display device, a server, and an external device. The display device comprises a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device. Further, the display device comprises a display for displaying the received implant control interface, and an input device for receiving implant control input from the user. The server comprises a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device. The external device comprises a wireless communication unit configured for wireless transmission of control commands to the system and configured for wireless communication with the server, and a computing unit. The computing unit is configured for running a control software for creating the control commands for the operation of the system, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the system.

According to an embodiment, a system for treating a patient with hypertension is provided, comprising a stimulation device comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patent to affect a vasomotor tone of a smooth muscle tissue of the renal artery, a source of energy configured to energize the electrode arrangement, a control unit operably connected to the stimulation device, and an elongated holding device. The elongated holding device is configured to be attached to an outer wall of the renal artery such that a length direction of the holding device extends along a flow direction of the renal artery. The holding device is further configured to support the electrode arrangement to allow the electrode arrangement to deliver the electric stimulation signal to the wall portion. The control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery.

In an example, the electrode arrangement is attached to a surface portion of the holding device and configured to rest against the outer wall of the renal artery.

In an example, the system further comprises an attachment device configured to fixate the holding device to the renal artery. In an example, the attachment device comprises at least one of a suture configured to be sutured to the renal artery and a clamping device configured to at least partly encircle the renal artery.

In an example, the attachment device is configured to be attached to the holding device and a tissue portion external to the renal artery.

In an example, the holding device is flexible.

In an example, at least one of the source of energy and the control unit is accommodated in the holding device.

According to an embodiment, a system for treating a patient suffering from hypertension is provided. The system comprises a stimulation device comprising an electrode arrangement configured to deliver an electric stimulation signal to a wall portion of a renal artery of the patient to affect a vasomotor tone of a smooth muscle tissue of the renal artery, a source of energy configured to energize the electrode arrangement, a control unit operably connected to the stimulation device and configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery, and a holding device configured to support the electrode arrangement at the outer wall of the renal artery to allow the electrode arrangement to deliver the electric stimulation signal to the wall portion. The holding device is configured to at least partly define a passage through which the renal artery passes, and to allow a width of the passage to follow changes in a width of the renal artery, such that the width of the passage increases with increased vasodilation and decreases with decreasing vasodilation.

In an example, the holding device comprises a flexible portion configured to rest against the outer wall of the renal artery and to follow a motion of the outer wall as the width of the renal artery varies in response to the vasodilation.

In an example, the holding device comprises a cuff arranged to at least partly encircle the renal artery.

In an example, the cuff comprises at least one abutment element having a varying volume and configured to rest against the outer wall portion of the renal artery.

In an example, the abutment element comprises an inflatable element configured to vary its volume in response to the width of the renal artery varying with the vasodilation.

In an example, the abutment element comprises a pneumatic or hydraulic element having an adjustable volume.

In an example, the system comprises a fluid reservoir, wherein the pneumatic or hydraulic element is fluidly connected to the fluid reservoir.

In an example, the system further comprises a pressure sensor device arranged to sense generate a signal indicative of a contact pressure between the holding device and the outer wall of the renal artery, wherein the control unit is further configured to cause the width of the passage of the holding device to vary based on the signal from the pressure sensor.

In an example, the control unit is configured to operate the holding device to maintain a substantially constant contact pressure between the holding device and the outer wall as the width of the renal artery varies with the vasodilation.

In an example, the control unit is configured to control an operation of the stimulation device based on the signal generated by the sensor device.

According to an embodiment, a system for treating a patient with hypertension is provided, comprising a stimulation device having a heating member configured to be implanted inside a renal artery of the patient, an implantable source of energy configured to energize the stimulation device, and a control unit operably connected to the stimulation device. The control unit is configured to control an operation of the stimulation device such that heat is exchanged between the heating member and a wall portion of the renal artery to cause vasodilation of the renal artery.

In an example, the source of energy is configured to be implanted inside the renal artery or integrated in the heating member.

In an example, the source of energy is configured to be charged by energy transferred from outside the renal artery, such as energy wirelessly transferred from outside the renal artery.

In an example, the heating member is configured to be heated by energy transferred from outside the renal artery, for instance by means of a wired connection.

In an example, the heating member is configured to be inductively heated by energy transferred from outside the renal artery.

In an example, the heating member has a tubular shape having an outer surface configured to rest against an inner surface of the renal artery.

In an example, the heating member defines a passage through which a blood flow of the renal artery is allowed to pass, and wherein the heating member is configured to follow change in a width of the renal artery such that a width of the passage increases with increased vasodilation and decreases with decreasing vasodilation.

In an example, the heating member comprises a flexible portion configured to allow the heating member to follow the change in width of the renal artery.

In an example, the heating member comprises a shape memory material configured to vary the width of the passage in response to a varying temperature of the heating member, thereby allowing the heating member to follow the changes in the width of the renal artery.

In an example, the heating member comprises a biocompatible material configured to promote fibrotic tissue growth thereon. In an example, the heating member is configured to be at least partly encapsulated by fibrotic tissue when implanted in the renal artery.

In an example, the heating member is configured to be secured to an inner surface of the renal artery.

In an example, the heating member is configured to be secured to the inner surface by means of sutures or staples.

According to an embodiment, a system for treating a patient with hypertension is provided. The system comprises a dilation device having an expansion member configured to be implanted inside a renal artery of the patient and to engage at least a portion of an inner circumferential surface of the renal artery, wherein the expansion member expandable to increase a width of the renal artery. The system further comprises an implantable source of energy configured to energize the dilation device, and a control unit operably connected to the dilation device. The control unit is configured to control an operation of the dilation device to induce vasodilation of the renal artery.

In an example, the source of energy is configured to be implanted inside the renal artery, such as being integrated in the expansion member.

In an example, the source of energy is configured to be charged by energy transferred from outside the renal artery, such as wirelessly transferred from outside the renal artery.

In an example, the expansion member is configured to be powered by energy transferred from outside the renal artery, for instance by means of a wired connection or inductively powered by energy transferred from outside the renal artery.

In an example, the expansion member is configured to be operated by means of mechanic, hydraulic or thermal action.

In an example, the system further comprises an operation device configured to control the operation of the expansion member. The operation device may comprise a hydraulic reservoir in fluid connection with the expansion member.

In an example, the expansion member comprises a shape memory material configured to vary a shape of the expansion member in response to a varying temperature of the expansion member.

In an example, the expansion member has a tubular shape having an outer surface configured to rest against an inner surface of the renal artery.

In an example, the expansion member defines a passage through which a blood flow of the renal artery is allowed to pass, and wherein the expansion member is configured to cause vasodilation by increasing a width of the passage.

In an example, the expansion member comprises a biocompatible material configured to promote fibrotic tissue growth thereon. In an example, the expansion member is configured to be at least partly encapsulated by fibrotic tissue when implanted in the renal artery.

In an example, the expansion member is configured to be secured to an inner surface of the renal artery.

In an example, the expansion member is configured to be secured to the inner surface by means of sutures or staples.

Any embodiment, part of embodiment, example, method or part of method may be combined in any applicable way within the terms of the appended claims.

Brief description of drawings

The inventive concept is now described, by way of example, with reference to the accompanying drawings, in which:

Figures la-b show an example of the kidneys of a human patient, and the blood vessels supplying the kidneys with blood.

Figure 2 shows an example of the innervation of the renal arteries leading to the kidneys.

Figures 3a-b shows the mechanisms of vasoconstriction and vasodilation in a blood vessel.

Figures 4-8 show various examples of medical devices implanted to electrically or otherwise induce vasodilation in the renal artery.

Figures 9a-d show various examples of electrodes.

Figures lOa-c are diagrams illustrating signal damping signals as applied in the context of the present inventive concept.

Figure 11 is a schematic outline of a system for affecting the blood pressure in a patient.

Figures 12a-d and 13a-b are various examples of sensors.

Figure 14 illustrate an electrical stimulation device and a sensor implanted at the rental artery.

Figures 15 and 16 show diagrams illustrating electric stimulation signals.

Figures 17a-c, 18 and 19a-d illustrate the mechanisms behind formation of fibrin.

Figures 20-22 and 23a-b illustrate various example of coatings.

Figures 24a-f and 25a-h illustrate systems according to some examples of the present inventive concept.

Figure 26 illustrate a remote unit when implanted in the body of a patient.

Figures 27, 28, and 29a-c illustrate a remote unit according to some examples.

Figures 30a-b, 3 la-b and 32a-b show various examples of a connection portion of a remote unit.

Figure 33 illustrate a kit for assembling an implantable medical device. Figures 34-37 show implantable remote units according to some examples.

Figures 38a-b show cross sections of a remote unit according to an example.

Figures 39a-d show various examples of orientation of a first unit relative to a second unit of the remote unit.

Figures 40 and 41 show a remote unit when implanted.

Figures 42 and 43 show examples of different dimensions of the remote unit. Figures 44a-c show a procedure of inserting a remote unit in a tissue portion. Figure 45 shows an example of a remote unit comprising at least one coil.

Detailed description

In the following, a detailed description of embodiments of the invention will be given with reference to the accompanying drawings. It will be appreciated that the drawings are for illustration only and are not in any way restricting the scope of the invention as defined by the appended claims. Thus, any references to directions, such as “up” or “down”, are only referring to the directions shown in the figures. It should be noted that the features having the same reference numerals generally may have the same function. A feature in one embodiment could thus be exchanged for a feature from another embodiment having the same reference numeral, unless clearly contradictory. The description of the features having the same reference numerals should thus be seen as complementing each other in describing the fundamental idea of the feature and thereby showing the versatility of the feature.

Vasodilation of a blood vessel, or dilation of the blood flow passageway of the blood vessel, is to be understood as an operation increasing a cross-sectional area of the inside space of the vessel. The renal artery is an example of a blood vessel, or luminary organ which can be filled with, and/or convey a flow of, a bodily fluid such as blood.

In the context of the present application, the term “renal artery” may be understood as any blood vessel providing a (main) supply of blood to a kidney. In case of a transplanted or artificial kidney, which often is placed in a location different from the original kidney, such as the iliac fossa, the renal artery may be connected to the external iliac artery. The present inventive concept may thus be applied also to such a blood vessel.

A control unit or controller is to be understood as any implantable unit capable of controlling the operation of an electrically operated device, such as a stimulation device or a signal damping device. A controller could include an electrical power source or another operation device for operating the stimulation device and the signal damping device. A control unit may also be understood as an element comprising circuitry configured to carry out various functions, such as data storage and processing, and signal generation. The control unit may be configured to transmit the control instructions to the stimulation device over a wired channel or a wireless channel. Further, the control unit may comprise an external part configured to be arranged outside the body of the patient and an internal part configured to be implanted in the patient. The internal and external parts may be configured to communicate wirelessly with each other, for example by means of radiofrequency signals or inductive signals.

A control signal is to be understood as any signal capable of carrying information and/or electric power such that for instance the stimulation device can be directly or indirectly controlled.

An implantable operation device, sometimes also referred to as a controller, may further be understood as any device or system capable of operating an active implant. An operation device or controller could for example be an actuator such as a hydraulic actuator including for instance a hydraulic pump or a hydraulic cylinder, or a mechanical actuator, such as a mechanical element actuating an implant by pressing or pulling directly or indirectly on the implant, or an electromechanical actuator such as an electrical motor or solenoid directly or indirectly pressing or pulling on the implant. The operation device may comprise a control unit as described above, and/or circuitry configured to carry out such functions.

Blood pressure is generally referred to as the pressure of circulating blood against the walls of blood vessels. Most of this pressure results from the heart pumping blood through the circulatory system. In common language, the term ‘blood pressure’ often refers to the pressure in the larger arteries. Blood pressure is usually expressed in terms of the systolic pressure (maximum pressure during one heartbeat) over diastolic pressure (minimum pressure between two heartbeats). Blood pressure can be understood as being influenced by cardiac output, systemic vascular resistance and arterial stiffness and may vary depending on situation, emotional state, activity, and relative health/disease states.

Blood pressure that is too low is called hypotension, pressure that is consistently too high is called hypertension, and normal pressure is called normotension. Long-term hypertension is a risk factor for many diseases, including stroke, heart disease and kidney failure. The Task force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) has provided the following definitions of hypertension:

Category Systolic BP, mmHg Diastolic BP, mmHg

Optimal < 120 < 80

Normal 120-129 80-84

High normal 130-139 85-89

Grade 1 hypertension 140-159 90-99

Grade 2 hypertension 160-179 100-109 Grade 3 hypertension > 180 > 110

The risk of cardiovascular disease is considered to increase progressively above 115/75 mmHg. Below this level there is limited evidence.

Vascular resistance is the resistance that must be overcome to push blood through the circulatory system and create flow. The resistance offered by the systemic circulation is known as the systemic vascular resistance (SVR). Vasoconstriction (i.e., decrease in inner blood vessel diameter) increases the SVR, whereas vasodilation (increase in inner diameter) decreases the SVR.

Many mechanisms have been proposed to account for the rise in SVR in hypertension. Most evidence implicates either disturbances in the kidneys' salt and water handling (particularly abnormalities in the intrarenal renin-angiotensin system, RAS) or abnormalities of the sympathetic nervous system. The mechanisms are not mutually exclusive, and it is likely that both contribute to some extent in hypertension. Excessive sodium or insufficient potassium in the diet may lead to excessive intracellular sodium, which may contract vascular smooth muscle tissue, restricting blood flow and so increases the blood pressure.

The renin-angiotensin system, RAS, is a hormone system that has been found to regulate blood pressure as well as systemic vascular resistance. When renal blood flow is reduced, which may be the case in for instance hemorrhage or dehydration, juxtaglomerular cells in the kidneys convert the precursor prorenin (already present in the blood) into renin and secrete it directly into circulation. This starts a chain reaction that eventually results in the release of angiotensin II, which has shown to be a potent vasoconstrictive peptide that may cause blood vessels to narrow and the blood pressure to increase accordingly. Angiotensin II is also known to be involved in an increase of extracellular fluid in the body, which also increases blood pressure.

The present invention is based on the realization that by causing an electrically induced vasodilation of the renal artery, a reaction that causes a reduction of the systemic vascular resistance may be triggered. The electrically induced vasodilation of the renal artery may be achieved by means of a stimulation device, which may be arranged to stimulate a nerve innervating the renal artery and/or to provide a direct or indirect stimulation of the smooth muscle tissue of the renal artery.

The stimulation device may be adapted to alter the vasomotor tone of the smooth muscle cells of the renal artery, causing the cells to relax. Sympathetic stimulation (norepinephrine) has been observed to constrict some blood vessels and dilate others, depending on whether the target cells (i.e., the smooth muscle cells) has alpha- or beta-adrenergic receptors. The sympathetic nervous system can also constrict or dilate vessels just by changing firing frequency. An increased firing frequency may cause the smooth muscle to contract and constrict the vessel, whereas a reduced firing frequency may cause the smooth muscle cells to relax, allowing blood pressure to dilate the vessel.

The inventor has realized that the electric stimulation device may be employed to affect the vasomotor tone of the smooth muscle cells to cause the lumen to relax, with the aim of triggering a reduction of the systemic vascular resistance. The electric stimulation device may thus form part of a system for treating a patient with hypertension.

While the focus of the present application may be laid on inducing vasodilation to trigger a bodily reaction to reduce the systemic blood pressure, it will be appreciated that the inventive concept of utilizing electrical stimulation for affecting the vasomotor tone of the renal artery may as well be employed for triggering a response increasing the systemic blood pressure. The present inventive concept may hence be applied also for treating patient suffering from hypotension. The aspects, embodiments and examples herein may be combined with implementations wherein electrically induced vasoconstriction is generated by electrical stimulation. The vasoconstriction may be achieved by controlling the electrical stimulation signal such that a contraction of the renal artery is achieved.

The inventor has further realized that a control, or regulation, of the electrically induced vasodilation may be achieved by providing a sensor, or sensor device, capable of generating a signal indicative of a blood pressure of the patient. The output signal from the sensor may then be supplied to a control unit, which is configured to control an operation of the stimulation device based on the signal generated by the sensor. The control unit may in some examples utilize the signal from the sensor as a trigger signal, indicating that the stimulation may be initiated and/or ceased. In further examples, the control unit may utilize the signal from the sensor as a feedback control signal, preferably driving the system (and hence the vasodilation or even systemic blood pressure) to a desired state (such as normotension. Exemplary embodiments, effects and advantages of using such an optional sensor is described in further detail in connection with figures 12 to 14.

Furthermore, the electrical stimulation signal used for causing the renal artery to relax may inadvertently progress towards the aorta and/or the spinal cord, thereby risking causing unwanted side effects and unpleasant experiences for the patient. Therefore, a signal damping device may according to some implementations of the inventive concept be provided to mitigate the effects of the electrical stimulation signal by damping, disturbing or at least partly cancelling the electrical stimulation signal, thereby limiting the spreading of the electrical stimulation signal to other parts of the patient’s body. Exemplary embodiments of signal damping approaches is discussed below with reference to figures 6-8, 10 and 11.

As an introduction to the field in which the present inventive concept can be applied, an exemplary description of the neurophysiology of the renal artery will be described in the following. It is to be noted that the following description of the neurophysiologic mechanisms affecting vasoconstriction of the renal artery is exemplary, simplified where needed, and based on the present knowledge in the art. The purpose of the following exemplary description of the bodily functions and responses is primarily not to limit or define the inventive concept, but to give an exemplary technical/physiological background and context of the inventive concept.

Figures la and b are schematic illustrations of the kidneys of an adult, human patient. It is common for a normal human to have two kidneys 10, each of which being connected to the circulatory system by means of a renal artery 20 that carries blood from the heart to the kidneys 10 via the aorta 22 and renal vein 30 that drains the kidney 10 and connects it to the inferior vena cava 32.

Figure 2 shows the kidneys 10 and the main renal arteries (MRA) 20, which are identified as the renal main blood supply arteries arising from the aorta 22 and ending at its bifurcation split. Although the illustrations in the present application show a single renal artery 20 connecting a respective kidney 10, the inventive concept is equally applicable to patients wherein a kidney is supplied by multiple renal arteries, which may have a separate origin in the aorta 22. In case of multiple renal arteries, the electrical stimulation may be delivered to at least one of the renal arteries, such as the vessel with the greatest diameter (this may consequently be referred to as the MRA).

Renal nerves 24 may be identified as fiber structures originating from ganglia in the solar plexus or from the splanchnic nerve collection, forming the renal plexus. The renal nerve plexus may thus be understood as the network of nerve fibers 24 innervating the renal artery 20 as well as the kidney 10. It appears as a major part of the nerves are sympathetic nerves, but the renal plexus may according to some findings also comprise parasympathetic nerves. Beneficially, the stimulation device may be arranged to deliver the electric stimulation to a parasympathetic nerve at least in a branch of a spinal cord dispatching number 10 and along the Coccygeal nerves originating at vertebrae S2-S4, preferably S4.

Figures 3a and b illustrate the concept of vasoconstriction and vasodilation. The open cross section of the lumen formed by the blood vessel, such as the renal artery 20 showed in figures 3a and b, may be determined by the vasomotor tone of the smooth muscle cells. The smooth muscle cells of the wall of the renal artery 20 may be innervated by nerve fibers 24, such as for instance sympathetic nerve fibers 24. Sympathetic stimulation has been observed to constrict some blood vessels and dilate others, depending on whether the smooth muscle cells have alpha- or beta- adrenergic receptors. As mentioned above, the sympathetic nervous system can also constrict or dilate vessels just by changing frequency of the action potentials of the nerve fibers 24. In the present figures, an example is illustrated in which an increased action potential frequency (indicated by pulses 26) may cause the smooth muscle tissue to contract, leading to vasoconstriction as illustrated in figure 3a. Reducing the action potential frequency 26 may cause the smooth muscle tissue to relax, leading to vasodilation as illustrated in figure 3b. The stimulation device according to the present inventive concept may be employed to modify the action potential frequency to cause a relaxation of the smooth muscle tissue. Put differently, the stimulation device may be operated to change the vasomotor tone of the smooth muscle tissue of the vessel. The electrical stimulation may be delivered directly to the outer wall of the renal artery 20, or to the nerve fibers 24 innervating the wall of the renal artery 20.

Figure 4 shows a renal artery 20 connecting a kidney 10 to the aorta 22, and which may be similar to the renal arteries 20 disclosed in figures 1 -3. In order to treat hypertension, a stimulation device 110 may be implanted in the patient. The stimulation device 110 may comprise an electrode arrangement, such as a first electrode arrangement 112, configured to deliver an electric stimulation signal to tissue of the patient, thereby causing tissue of a wall portion of the renal artery 20 to relax and dilate a blood flow passageway of the renal artery 20. In the present example, the first electrode arrangement 112 is configured to be attached to the outer wall of the renal artery 20 to deliver an electric stimulation signal to the smooth muscle tissue of the renal artery wall 22. In this way, the smooth muscle tissue may be subject to an electrical stimulation that causes vasodilation.

The first electrode arrangement 112 may for example comprise a plurality of electrical electrodes 112a, 112b, each of which having a contacting portion, or electrode element 112a, configured to be arranged to engage the wall of the renal artery 20, and a lead portion 112b electrically connecting the contacting portion 112a to a control unit 114 of the stimulation device 110. The contacting portion 112a of the first electrode arrangement 112 may for example be attached to the wall of the renal artery 20 by means of stitches, for instance allowing for the contacting portion 112a to be at least partly inserted into the tissue on the outer surface of the wall. In further examples, the contacting portion 112a may be arranged on a surface portion, such as a patch (not shown), which in turn may be placed on the tissue of the wall of the renal artery 20.

The control unit 114 may be configured to be electrically connected to the electrode arrangement 112 to provide the contacting portions 112a with the electric stimulation signal. The control unit 114 may thus in turn be operatively connected to, or comprise, a power source energizing the control unit 144 and the electrode arrangement 112. Further, the device may according to some embodiments comprise an additional control unit, also referred to as a central control unit, which may be implanted in the body or be a remote unit, arranged outside the body. Further, the control unit 114 may in some examples be configured to transmit control instructions wirelessly to the stimulation device. The number of contact points, in which the electric stimulation signal can be delivered to the smooth muscle tissue, may be selected based on the desired response and the characteristics of the stimulation signal used. Increasing the number of contact points may for example allow for a lower signal amplitude required to generate the desired response (i.e., a relaxation) of the muscle tissue. Conversely, an increase signal amplitude may be used for allowing a reduce in number of contact points. Further, it will be appreciated that some or all of the contacting portions 112a may be individually controlled with respect to the stimulation signal, such that the stimulation signal can be selectively and controllable delivered to one or several of the contact points at the time. The selective application at different contact points may for example be enabled by the control unit 114.

When a reduction in systemic vascular resistance is desired, the stimulation device 110 may be operated to generate an electrical stimulation signal that is transmitted from the control unit 114 through the leads 112b to the contacting portions, or electrode elements 112b, which deliver the electrical stimulation signal to the muscle tissue of the wall of the renal artery 20. The electrical stimulation signal may be configured, with respect to e.g. voltage, current or frequency, to trigger a vasodilation response in the renal artery. The vasodilation may in turn result in a systemic response as described above.

Figures 5a-h show a renal artery 20 which may be similar to the renal arteries disclosed in the previous figures. Figure 5a-d further disclose a stimulation device which may be similarly configured as the one disclosed in connection with figure 4, and may thus comprise an electrode arrangement 112a, 112b configured to deliver an electric stimulation signal for affecting vasomotor tone in the renal artery 20. The stimulation device may comprise a plurality of contacting portions 112a, or electrode elements 112a, configured to mechanically engage, or be arranged to rest against, tissue of an outer wall of a portion of the renal artery 20 to transmit the electrical stimulation signal to the tissue. In the example in figure 5a, the electrode elements 112a are arranged on an inner surface of a cuff portion 116 configured to be arranged at least partly around the renal artery 20. The cuff portion 116 may in turn be electrically connected to the control unit 114 of the stimulation device 110 by means of a lead 112b. Further configurations are disclosed in figures 5b-d, in which the electrode elements 112a are supported by an elongated holder 116 arranged to keep the electrode elements 112a in the desired position at the wall of the renal artery 20. The holder 116, also referred to as a holding device 116, is formed as an elongated device configured to be attached on the outer wall of the renal artery such that a length direction L of the holder 116 extends along a flow direction of the artery 20. Further, an attachment device may be provided to assist in fixating the holder 116 to the renal artery 20. The attachment device may for instance be formed of at least a part of the electrode element 112a, as shown in figure 5c, which may be arranged to at least partly encircle the renal artery 20 and thereby act as a clamp for fixating the holder 116 to the artery 20. Alternatively, or additionally, the attachment device may comprise a suture (not shown) configured to be sutured to the artery to assist in fixating the holder 116. In further examples, such as the configuration shown in figure 5d, the attachment device is configured to be attached to a tissue portion external to the renal artery 20. This may be realized by a supporting rod 116’ or lever adapted to extend from the holder 116 and to be attached to tissue surrounding the renal artery 20 or the kidney 10 by means of, for instance, sutures or staples. Beneficially, the supporting rod 116’ may eventually be embedded or encapsulated by fibrotic tissue assisting keeping the holder 116 and the electrode arrangement 112a in the correct position.

It will be appreciated that the holder 116 may be flexible to allow some movement of the stimulation device 110 when implanted. The movement may for instance be caused by the patient moving, or by vasodilation of the artery 20. Further, at least one of a source of energy and control unit of the system may be accommodated in the holder 116.

In the above, vasodilation induced by electrical stimulation of nerves have been discussed. Alternative or additional mechanisms for causing the renal artery to expand or contract are however possible, and can beneficially be combined with the inventive concept disclosed in the present application. Two examples of such mechanisms will now be discussed with reference to figures 5e- i, namely thermally induced vasodilation and mechanically induced vasodilation.

Figure 5e shows a portion of the renal artery 20 in figures 5a-d, in which a stimulation device 110 having a plurality of heating members 117 have been implanted. In this embodiment, the control unit 114, 124 is configured to control an operation of the stimulation device such that heat is exchanged between the heating members 117 and the wall portion of the renal artery 20 to cause vasodilation thereof. The heat energy may be provided from a source of energy that is implanted inside the renal artery 20, for example integrated in the heating member, or transferred from outside the renal artery 20. In the latter case, the energy may be transferred by means of a wired connection or wirelessly, such as inductively.

While the present figure shows heating members 117 shaped as electrodes attached to the interior of the artery, it will be appreciated that they may as well have a tubular shape with an outer surface configured or rest against the inner surface of the artery, or be attached to such a tubular structure to facilitate insertion and possibly attachment in the vessel. An example of such a configuration is disclosed in figure 5f, in which a first and a second catheter 118 are inserted into the artery 20 through the arterial wall and arranged such that the heating members 117 are in thermal contact with the interior side of the artery 20.

In yet a further example, the heating member 117 may define a passage through which a blood flow of the renal artery 20 is allowed to pass. The heating member 117 may thus have a shape conforming to a stent abutting the inner surface of the artery. Beneficially, the heating member 117 may comprise a flexible or expandable portion configured to allow the heating member 117 to follow the change in width of the artery 20 such that a width of the passage increases with increased vasodilation and decreases with decreasing vasodilation. The heating member 117 may comprise a shape memory material configured to vary the width of the passage in response to a varying temperature of the heating member. Further, the heating member may comprise a biocompatible material configured to promote fibrotic tissue to promote fibrotic tissue growth thereon - especially on portions arranged outside the artery, such as the external portion of the catheter 118 shown in figure 5f. Preferably, the heating member may be configured to be secured to an inner surface of the artery, where it may be at least partly encapsulated by fibrotic tissue when implanted. Alternatively, or additionally the heating member may be secured to the inner surface by means of sutures or staples.

It will be appreciated that the heating member 117 in some examples may have a cooling capacity allowing it to cool the wall of the renal artery 20 to cause the artery to contract. The heating member 117 may thus also be referred to as a thermal member, having the capacity to transfer heat to the wall and/or transfer heat from the wall. The operating mechanism of the thermal member may be based on a resistive heating, or the Peltier effect. In further examples, the heat may be transferred by means of a carrier fluid, such as water, arranged to add or remove heat from the wall of the artery 20.

During operation, the control unit 114, 124 may operate the stimulation device 110 such that the thermal member 117 is heated, thereby heating the renal artery 20 locally at position of the thermal member 117. As a result, a dilation of the blood vessel 20 may be achieved, allowing the blood to flow more freely within the renal artery 20 and thereby increase the blood pressure in the kidney 10.

Mechanically induced vasodilation will now be discussed with reference to figures 5g-h, in which the renal artery 20 may be expanded by means of dilation device having an expansion member 212 implanted inside the artery. The expansion member 212 is configured to engage at least a portion of a in inner circumferential surface of the renal artery 20 and exert and expanding pressure on the wall of the renal artery 20 to assist in the vasodilation. Thus, the expansion member 212 may be used instead of the thermal or electrical stimulation devices discussed above, or in combination with either of them. Similar to the previous stimulation devices, the operation of the dilation device may be controlled by the control unit 112, 124 and energized by a source of energy similarly configured as the previously discussed sources of energy. Thus, the source of energy may be configured to be implanted inside the renal artery, be integrated in the expansion member, or arranged outside the renal artery. In the latter case the energy may be transferred wirelessly, such as inductively, or by means of a wired connection. Further, the source of energy may be charged by energy wirelessly transferred from outside the renal artery, such as from an extraluminar source of energy which may be implanted elsewhere in the body or arranged outside the body of the patient.

The expansion member 212 may be understood as a device suitable for implantation inside the artery and possible to controllably expand and/or contract so as to cause vasodilation. The expansion may for example be caused by means of mechanic, hydraulic or thermal action as will be discussed in the following. Further, the expansion member may comprise a tubular shape having an outer surface configured to rest against the inner surface of the renal artery 20. The expansion member 212 may for instance define a passage through which a blood flow of the renal artery 20 is allowed to pass. The expansion member 212 may be secured at its position by means of sutures or staples, and/or by means of fibrotic tissue at least partly covering or encapsulating the expansion member 212. Preferably, the expansion member 212 comprises a biocompatible material promoting fibrotic tissue growth.

In the example shown in figure 5g the expansion member may be a tubular structure, such as a stent-like structure, configured to be fitted within the inner walls of the artery 20. The tubular structure may be formed by a net-like structure, and preferably by a shape-memory materials that varies its shape with the temperature. This allows for the passageway defined by the expansion member to vary its cross-sectional area with the temperature, such that a heating of the tubular structure may cause the structure to expand and thereby induce vasodilation in the renal artery 20. Correspondingly, a cooling of the tubular structure may result in the structure contracting, reducing the pressure on the arterial wall and allowing it to contract again.

The heating may for instance be achieved by resistive heating of the shape-memory material, either directly or indirectly, or by means of additional heating elements (such as the ones disclosed in connection with figures 5e-d).

An alternative principle of operation of the expansion member 212 is shown in figures 5h-i, in which the expansion member 212 comprises at least one hydraulic expansion means, or bellows 214, operable to cause the expansion member 212 to increase its circumference. In the present example, the expansion member 212 is cylindrical or at least ring-shaped and comprises a first and a second abutment element 213 configured to be arranged to rest against the inner surface of the artery 20. The abutment elements 213 are interconnected by a first and a second bellows 214, which are hydraulically operated via a hydraulic reservoir (not shown) to cause the first and second abutment elements 213 to expand the arterial wall. The hydraulic reservoir may be implanted at a location different from the renal artery, and a motor or pump may be employed to move hydraulic fluid between the bellows and the reservoir to control the expansion and contraction. The motor or pump may be controlled by the control unit 114, 124 as discussed above. Other operation principles are also possible, such as a mechanical expansion means instead of the bellows 214. A threaded, rotating bolt is an example of such a mechanical expansion means, wherein the bolt may be moved into and out from a nut to cause the expansion member 212 to increase or reduce its width.

Figure 5i illustrates the hydraulic expansion member 212 in figure 5h when implanted in the renal artery 20, whereas figure 5j shows the stent-like expansion member 212 in figure 5g when implanted.

Figure 6 shows a similar renal artery 20 as in figures 5a-j, in which a signal damping device 120 has been implanted to at least partly enclose a portion of the renal artery 20. The signal damping device 120 may comprise a second electrode arrangement 122a, 122b configured to deliver an electric signal for damping or disturbing the electrical stimulation signal generated by the stimulation device 110, which may be similar to the ones disclosed in figures 4 and 5. Alternatively, the signal damping device 120 is configured to divert the electrical stimulation signal, for instance by connecting a portion of the renal artery to ground or at least to a lower electrical potential, allowing the electric stimulation signal to travel towards the reduced potential rather than towards the spinal cord of the patient. The damping device 120 may be provided and operated with the purpose of reducing the effect of the electric stimulation signal on parts of the body other than the renal artery 20.

The utilization of the signal damping device 120 relies on the insight that the electrical stimulation signal used for causing the renal artery 20 to relax inadvertently may progress towards the spinal aorta 22 and/or the spinal cord, thereby risking causing unwanted side effects and unpleasant experiences for the patient. The signal damping device 120 may hence be provided to mitigate the effects of the electrical stimulation signal by damping, disturbing or at least partly cancelling the electrical stimulation signal on its way away from the renal artery 20 and the kidney 10. The signal damping device 120 may hence be arrange to at least partly intercept the electrical stimulation signal during its progress through the tissue towards the aorta 22/spinal cord. These mechanisms are discussed in greater details below, for instance in connection with figures lOa-c.

The functionality of the medical device 110 generating the electric stimulation signal, i.e., the control unit 124 and the electrode arrangement 112a, 112b may also be referred to as a stimulation device 110. The stimulation device 110 and the signal damping device 120 may hence be operated at the same time, or simultaneously, to treat hypertension. The stimulation device 110 may be operated to deliver the stimulation signal and cause vasodilation, while the signal damping device 120 is operated to damp or disturb the stimulation signal propagating towards tissue for which electrical stimulation is unwanted. The signal damping device 120 may be arranged to engage tissue of the renal artery 20, or a nerve innervating the renal artery 20, at a position allowing the stimulation device 110 to be arranged between the kidney 10 and the signal damping device 120. By this placement, the signal damping device 120 may be employed to prevent or at least partly hinder the electrical stimulation signal from propagating ‘upstream’ the nerve or renal artery 20, that is, towards the spinal cord or aorta.

In the present example, the stimulation device 110 may comprise a first electrode arrangement 112 comprising a plurality of electrode elements 112a configured to engage the wall of the renal artery 20. The electrode elements 112a may be connected to a control unit 114 by means of electrical lead portions 112b and configured to deliver an electric stimulation signal generated by the control unit 114. The contacting portions 112a may for example be attached to the wall of the renal artery 20 by means of stitches, for instance allowing for the contacting portion 112a to be at least partly inserted into the tissue on the outer surface of the wall, or arranged on a surface portion, such as a patch (not shown), which in turn may be placed on the tissue of the wall of the renal artery 20.

The signal damping device 120 may comprise a plurality of contacting portions 122a, or electrode elements 122a, configured to mechanically engage, or be arranged to rest against, a portion of the renal artery 20 to transmit the electrical stimulation signal to the tissue. In the present example, the electrode elements 122a are arranged on an inner surface of a cuff portion 126 configured to be arranged at least partly around the renal artery 20. The cuff portion 126 may in turn be electrically connected to the control unit 124 of the stimulation device 110 by means of a lead 122b.

During operation, when a reduction of blood pressure, or systemic vascular resistance, is desired, the signal damping device 120 may be caused to deliver an electrical damping signal preventing or at reducing propagation of the stimulation signal delivered to the renal artery 20. The electrical damping device 120 may for instance be configured to counteract or damping the action potentials that may be generated by the stimulation signal, thereby reducing the reaction from muscle cells or nerve cells in the vicinity of the electrode elements 122a of the signal damping device 120. Additionally, or alternatively, the electrical damping device 120 may be configured to deliver an electrical damping signal which is configured to cancel or damp the electrical stimulation signal by means of amplitude cancellation or by scrambling the signal (e.g., in terms of frequency contents) into a signature which cannot be ‘read’ by the muscle tissue or the nervous tissue. In different words, the electrical stimulation signal may be modified in a way that reduces its effect on tissue. Combinations are conceivable: the signal damping device 120 may be arranged to counteract or damp the action potentials affecting tissue such as smooth muscle cells and nerve cells and to damp or disturb the electrical stimulation signal before it propagates past the electrode elements 122b of the signal damping device 120.

Figures 7a-b are cross sections of devices for delivering an electric signal to tissue of the patient. The devices may for example be a stimulation device 110 or a signal damping device 120, similarly configured as any of the embodiments described above with reference to figures 4-6. In the following description of figure 7a the device will be exemplified as a signal damping device 120. However, it will be appreciated that the description may equally well apply to a stimulation device 110.

In the present example, the signal damping device 120 may comprise a support structure 126, such as for example a cuff 126, which may be formed to two or more support elements that are hingedly connected to each other and movable to allow the support structure 126 to be arranged around the renal artery 20. The support structure 126 may thus be arranged to at least partly, or completely, surround the renal artery 20, such that an inner surface portion of the support structure 126 faces or abuts an outer wall surface of the renal artery 20 when implanted. The support structure 126 may for instance be positioned by the surgeon attaching two or more interconnecting support elements to each other, when the support structure 126 is positioned around the renal artery 20. The inner circumference of the support structure 126 may be adapted to fit snuggly around the renal artery 20, and may either be adjustable, for instance by varying an overlap of the elements forming the support structure 126 upon attachment to the renal artery 20, or by selecting a support structure 126 (out of a plurality of different support structures) having a suitable circumference.

The inner surface may be adapted to support one or several electrode elements, or contacting portions 122a, for delivering an electrical damping signal to the tissue of the renal artery 20, or for connecting the tissue of the renal artery 20 to a lower electrical potential, such as ground, to divert the electrical stimulation signal from the tissue to the lower electrical potential. In this way, the signal damping device 120 may be capable of preventing the electrical stimulation signal from propagating past the signal damping device 120, or at least of reducing the impact of the electrical stimulation signal otherwise may have on tissue in the vicinity of, or upstream, the signal damping device 120. The electrode elements 122a may be electrically connected to a ground potential, or at least to a lower electric potential, by means of electrical leads 122b. Alternatively, the electric leads 122b connect the electrode elements 122a to a control unit 124 configured to generate a signal for damping or disturbing the electric stimulation signal, as described above.

The electrode elements 122a may preferably be arranged at the interface or contact surface between the support structure 126 and the tissue. The electrode elements 122a may for instance be plate electrodes, comprising a plate-shaped part forming contact with the tissue (as already stated, this applies both to signal damping devices as well as stimulation devices). In other examples, the electrode elements 122a may be a wire electrode or a lead, formed of a conducting wire that can be attached to the inner surface of the support structure 126 and brought in electrical contact with the tissue. Further examples may include needle- or pin-shaped electrodes, having a point at the end which can protrude from the inner surface of the support structure 126 and be inserted in the tissue of the wall, at which the signal damping device 120 or stimulation device 110 may be arranged to rest.

The control unit 124 may be operably connected to the electrode elements 122a for controlling the electric damping (or stimulation) signal provided to the tissue of the renal artery 20. The control unit 124 may be structurally integrated in the stimulation device shown in for example figure 6 and may be configured to receive input from a sensor arranged to sense or measure the electric stimulation signal generated by the stimulation device 110. In some examples, the sensor may be integrated with the control unit 124.

The sensor (not shown in figure 7) may be arranged in close vicinity of the portion of the renal artery 20 at which the electrode elements 122a contact the tissue of the renal artery 20. This advantageously may allow for the characteristics of the electrical stimulation signal to be determined close to the location of the signal damping device so that the damping device more efficiently can generate a damping or counteracting signal.

In a further configuration the cuff 126 of the stimulation device 110 and/or signal damping device 120 may be configured to adapt its shape, and more specifically its inner cross section, to the vasodilation so as to maintain a certain contact or abutment with the outer surface of the renal artery 20. This may for instance be realized by means of a hydraulically or pneumatically operated cuff 126 configured to maintain a substantially constant contact pressure between the artery 20 and the cuff 126, or by means of a mechanically operated adjustment mechanism configured to adjust the inner circumference of the cuff 126 according to the vasodilation.

An example is shown in figure 7b, disclosing a holding device 126, such as a cuff, configured to support the electrode arrangement 122a at the outer wall 18 of the artery and to define a passage through which the artery passes. The cuff 126 further comprises a plurality of abutment elements 127 having a varying volume and being configured to rest against the outer wall portion 18 of the artery. The varying volume allows a width of the passage, through which the artery passes, to increase with increased vasodilation and decrease with decreasing vasodilation. In the example shown in figure 7b the abutment elements comprises inflatable elements 127 varying their volume in response to the width of the artery varying. The abutments elements 127 are hydraulic or pneumatic elements fluidly connected to a fluid reservoir 128. The control unit 124 may be configured to cause fluid to be transported between the fluid reservoir 128 and the inflatable elements 127 based on a contact pressure between the holding device 126 and the outer wall 18 of the artery so as to control the volume of the inflatable elements 127 and thus the contact pressure accordingly. The contact pressure may be determined by means of a pressure sensor communicatively connected to the control unit 124. Further, in some examples the control unit 124 is configured to control an operation of the stimulation device, and thus the electric stimulation signal causing vasodilation, based on the signal generated by the sensor device.

Figure 8 schematically illustrates an example of the innervation of the renal artery 20, and shows the kidney 10, the aorta 22 and the renal artery 20 connecting the two. As mentioned above, the renal artery 20 may be innervated by renal sympathetic fibres 24 originating from ganglia in the solar plexus or from the splanchnic nerve collection and connecting the renal artery 20 as well as the kidney 10 forming the renal plexus. It is believed that a major part of the renal plexus comprises sympathetic nerves 24, but the presence of parasympathetic nerves may not be excluded.

While the stimulation device 110 and the signal damping device 120 in the above examples are described as configured to deliver electric signals, such as the electrical stimulation signal and the electric damping signal, directly to tissue of the wall of the renal artery 20, it will be appreciated that the electrical stimulation device 20 and the signal damping device 120 also may be arranged to act on nerves instead (or in addition). Thus, the stimulation device 110 may in some examples be configured to engage and electrically stimulate the nerves 24 innervating the renal artery 20 to cause vasodilation thereof, thereby promoting a reduction in systemic vascular resistance. The electrical stimulation device 110 may be similarly configured as any of the stimulation devices described above with reference to the previous figures and may for instance comprise one or several electrode elements 112a or contacting portions that can be attached directly to the nerve 24, or arranged on a supporting structure, such as a cuff of the like, which can be attached to the nerve that that is at least partly encloses the nerve 24. The stimulating electrode elements may thus be attached directly to the nerve, at a position between the innervated muscle tissue and the spinal cord 20 from which the nerve may origin. It will be understood that while the electrode elements can be attached directly onto a wall of the renal artery, for instance by means of a patch or stitching, the electrode elements may need to be slightly differently configured to be able to engage a nerve instead. Mostly due to the differences in diameter between the renal artery and a nerve. In the latter case, the electrode elements may be arranged on the inner surface of a support device, such as a cuff, which is dimensioned to be fit snugly around the nerve. Thus, while electric stimulation of a wall, or an entire blood vessel, may require the electrode elements to be arranged on the wall, the electrode elements may be arranged around the nerve in case a nerve stimulation is desired. In some examples the electrode elements 112a are arrange at a position closer to the innervated tissue than to the ganglia in the solar plexus or the splanchnic nerve collection, from which the nerve 24 may origin. In the present figure, an exemplary configuration is illustrated in sympathetic renal fibers 24 are stimulated at two positions by a respective electrode element 112a, each connected to a control unit 124 by means of a lead 112b.

When submitting an electrical stimulation signal to a nerve 24, there is a risk that the signal propagates to surrounding tissue which should not be stimulated. The stimulation signal may for instance propagate not only to the renal artery wall (which should be stimulated), but also ‘upstream’ towards the ganglia from which the nerve 24 origins. This may cause unwanted reactions in other parts of the nervous system, and an unpleasant experience for the patient. To address this issue, a signal damping device 120 may be arranged to engage the nerve 24 upstream of the stimulation device 110, at a position between the stimulation device 110 and the ganglia from which the nerve 24 origins. In the present figure, a signal damping device 120 has been arranged to engage nerves 124 at two different locations ‘upstream’ the electrode elements 112a of the stimulation device 110. The signal damping device 120 may be similarly configured as any of the signal damping devices described above with reference to the previous figures and may for instance comprise one or several electrode elements 122a or contacting portions that can be attached directly to the nerve 24, or arranged on a supporting structure, such as a cuff of the like, which can be attached to the nerve that that is at least partly encloses the nerve 24. The stimulating electrode elements may thus be attached directly to the nerve, at a position between the electrode elements 112a of the stimulation device 110 and the spinal cord 20 from which the nerve 24 may origin. The signal damping device 120 may be configured to hinder, damp or scramble the electrical signal propagating from the electrode elements 112a of the stimulation device 110. Alternatively, the signal damping device 120 may be configured to divert the propagating stimulation signals to a lower potential, such as ground.

Alternative, or additional approaches to address potential issues originating from unintended or unwanted propagation of the electric stimulation signal may involve supplying an additional signal to the tissue in which the electric stimulation signal propagates, thereby reducing or at least partly counteracting the tissue’s reaction of the stimulation signal. Such an approach may rely on a mechanism relating to phase cancellation of the signal, in which the signal damping device 120 may be employed to deliver an electric signal to the muscle tissue of the renal artery 20 or the nervous tissue of the nerve 24, wherein the electric signal is configured to cancel or at least reduce the amplitude of the electric stimulation signal that has propagated from the electrode elements 112a of the electrical stimulation device 110. Generally, muscle cells are adapted to react on nerve fibre action potential waveforms, which in their natural state are biphasic (negativepositive) with a duration in the order of milliseconds. By adding a slightly phase shifted or reversed signal damping signal to the muscle tissue, the signal damping signal may be timed to position its negative peaks at the time of the positive peaks of the action potential originating from the stimulation signal propagating from the stimulation device 110. With a correct timing, a significant phase cancellation and lowering of the action potential waveform may be achieved, resulting in a reduced response from the muscle cells.

Figures 9a-d show examples of electrode arrangements according to some embodiments, which may be implemented in any of the signal damping devices and stimulation devices discussed above in connection with for instance figures 4-8.

Figure 9a is an example of a bipolar electrode arrangement comprising a first and a second electrode element El, E2, having a plurality of contact portions 122a which can be arranged to abut the tissue of the outer wall of renal artery 20 or nervous tissue 24 innervating the renal artery 20. The electrode arrangement may be operated as a bipolar electrode arrangement by connecting the first and second electrode elements El, E2 to different electrical potentials. Thus, the first electrode element El can be operated as an anode and the second electrode element E2 as a cathode. The electrode elements El, E2 may be attached directly to a surface of the stimulation device or signal damping device, such as to the inner surface of a support structure or cuff 126 as exemplified above. In some examples, the electrode elements El, E2 may be arranged on a support, such as a flexible patch, which may be configured to be attached to the tissue, such as the outer wall of the renal artery or a nerve 124. The electrode arrangement can be arranged between the support structure 126 and the tissue (such as disclosed in figure 7) and may in some examples be provided as a separate, physically distinct item and in other examples be integrated in the support structure 126. The electrode arrangement may comprise one or several contact pads, or contacting portions 122a, for increasing the contact surface between the electrode and the tissue when implanted. During operation, the electrical damping signal (or, when applicable, the electrical stimulation signal) may be delivered to the tissue by means of the first and second electrode elements El, E2 so as to damp, disturb or counteract the electrical stimulation signal (when arranged in a signal damping device) and to stimulate contraction of the muscle cells (when arranged in an electrical stimulation device).

Figure 9b is another example of an electrode arrangement of an electrical stimulation device 110 or a signal damping device 120 as discussed above. In the present example, the electrode arrangement may be operated as a unipolar electrode element or as a bipolar electrode arrangement. The electrode arrangement comprises a first electrode element El and a second electrode element E2 which may be formed of a wire or electrical lead arranged in a flat, coiled structure for increasing the contact surface between the electrode elements El, E2 and the tissue. Further, the coiled configuration allows for a certain mechanical flexibility of the electrode elements El, E2 such that they can follow the tissue during vasoconstriction and vasodilation, which makes them particularly suitable for direct engagement with the renal artery 20.

Figure 9c illustrates the end portion of a needle- or pin-shaped electrode element El, E2, wherein the active portion of the electrode element El, E2 is provided as a bare electrode surface 123 at the end of the electrode element El, E2. Thus, when implanted at or in the tissue, the active, bare electrode surface 123 of the electrode element El, E2 may form a metal-tissue interface with the tissue, wherein the interface may surround the end portion of the electrode element El, E2 so as to provide a relatively large contact surface. The present example is advantageous in that it can be inserted in the tissue, thereby allowing for a selective stimulation at a certain depth of the smooth muscle tissue. The electrode element El, E2 may for instance be arranged to protrude orthogonally from a surface of the support structure, such as the patch in figures 9a and b, and the inner surface of a cuff as illustrated in for instance figures 6 and 7.

Figure 9d shows a similar electrode element El, E2 as the one in figure 9c, with the difference that the present electrode element El, E2 comprises an active tip portion that is covered by a dielectric material 123’ to protect the electrode material from deterioration during long-term implantation and to facilitate capacitive current transfer to the tissue. The dielectric material 123’ may for instance be electrochemically deposited tantalum oxide, which allow the electrical charge to pass through the interface but reduces the risk for electrode corrosion, gas formation and metabolite reactions.

It will be appreciated that both faradaic and capacitive mechanisms may be present at the same time, irrespectively of the type of electrode used. Thus, capacitive charge transfer may be present also for a bare electrode forming a metal-tissue interface, and faradaic charge transfer may be present also for a coated electrode forming a dielectric-tissue interface. It has been found that the faradaic portion of the current delivered to the muscle tissue can be reduced or even eliminated by reducing the duration of the pulses of the electric signal. Reducing the pulse duration has turned out to be an efficient way of increasing the portion of the signal which can be passed through the interface as a capacitive current, rather than by a faradaic current. As a result, shorter pulses may produce less electrode and tissue damage.

The capacitive portion of the current may further be increased, relative to the faradaic portion, by reducing the amplitude of the current pulses of the electrical signal. Reducing the amplitude may reduce or suppress the chemical reactions at the interface between the electrode and the tissue, thereby reducing potential damage that may be caused by compounds and ions generated by such reactions.

In one example, the electrical stimulation may be controlled in such a manner that a positive pulse of the electrical signal is followed by a negative pulse (or, put differently, a pulse of a first polarity being followed by a pulse of a second, reversed polarity), preferably of the same amplitude and/or duration. Advantageously, the subsequent negative (or reversed) pulse may be used to reverse or at least moderate chemical reactions or changes taking place in the interface in response to the first, positive pulse. By generating a reversed pulse, the risk of deterioration of the electrode and/or the tissue at the interface between the electrode and the muscle tissue may be reduced. Figure 10a is a diagram illustrating a signal damping mechanism, or phase cancellation mechanism, according to some embodiments. Figure 10a schematically shows an electric stimulation signal comprising a series of positive pulses PL1, and an electric damping signal comprising a series of negative pulses PL2. The stimulation signal may originate from a stimulation device 110 arranged to cause vasodilation in the renal artery 20, whereas the electric damping signal may be generated by a signal damping device 120, comprising a control unit which may be arranged outside the body or be implanted in the body. The control unit may be operatively connected to an electrode arrangement by means of one or several leads. The electrode arrangement may comprise a plurality of electrode elements attached to the muscle tissue of the renal artery wall 20, to tissue in close vicinity of the muscle tissue of the renal artery, or a nerve innervating the renal artery, such that the electrode elements are allowed to deliver the damping signal to said tissue. The electrical signals shown in the present figure may either reflect the signal as generated at the stimulation device and signal damping device, respectively, or the signal as delivered to the tissue. In the present example, the electrical signals are pulsed signals comprising square waves PL1, PL2. However, this may be considered to represent an ideal signal, and it is appreciated that other shapes of the pulses may be provided as well. The pulse signals may be periodic, as shown, or intermittent (i.e., multiple series of pulses separated by periods of no pulses). The pulses may have an amplitude Al, A2, which may be measured in volts, amperes, or the like. Each of the pulses of the signals may have a pulse width DI, D2. Likewise, if the signal is periodic, the pulsed signals may have a period Fl, F2 that corresponds to a frequency of the signal. Further, the pulses may be either positive or negative in relation to a reference. In the present example, the signal originating from the propagating stimulation signal may comprise positive pulses PL1 whereas the damping signal may comprise negative pulses PL2.

In the present example, the electric stimulation signal may be a pulsed signal comprising square waves having a frequency in the range of 0.01-150 Hertz. The pulse duration may lie within the range of 0.01-100 milliseconds (ms), such as 0.1-20 ms, and preferably such as 1-6 ms. The natural muscle action potential has in some studies been observed to last about 2-4 ms, so it may be advantageous to use a pulse duration imitating that range when stimulating the tissue to cause it to relax.

The amplitude of the stimulation signal may for example lie within the range of 1-15 milliamperes (mA), such as 0.5-5 mA, in which range a particularly good muscle response has been observed in some studies.

In a preferred, specific example, the electrical stimulation delivered by the stimulation device 120 may hence be performed using a pulsed signal having a pulse frequency of 10 Hz, a pulse duration of 3 ms and an amplitude of 3 mA. The pulsed signal shown in figure 10a (in solid lines) may be considered to represent the characteristics of such a stimulation signal as it is propagating through the tissue of the renal artery 20. The damping signal (indicated by dashed lines) may be designed to counteract, or mitigate, the tissue’s response to the stimulation signal. In the example shown in the present figure, this may for instance be achieved by providing a series of pulses PL2 having a polarity that is reversed in relation to the pulses PL1 of the signal originating from the stimulation signal. Further, the damping signal may be phase shifted in relation to the positive pulses. The timing of the signals may hence be selected such that the negative pulses PL2 are positioned at the time of the positive peaks PL1, or slightly delayed relative the positive peaks PL1, as indicated in figure 10a. A negative pulse PL2 may be delivered to the tissue shortly after the positive pulse, before the cells have had time to react to the stimuli provided by the positive pulse. Put differently, the damping signal may be delivered to the cells at the onset of the change in cell polarization, thereby reducing or cancelling cell polarization. The negative pulse PL2 may thus act to counteract, or cancel, the stimuli provided by the positive pulse PL1, thereby preventing the cells from contract, or at least reducing the contraction triggered by the positive pulse PL1.

It should be understood that the signals illustrated in the above example are schematic and ideal, and not necessarily a true representation of the actual signals delivered to the tissue. The actual signals may be more complex, having a more complex frequency composition and comprising various degrees of noise. The illustration in figure 10a is purposely simplified to help elucidate the inventive concept of applying a damping signal to counteract or reduce the effects of the stimulation signal as it propagates to other parts of the body which are not the primary target of the stimulation. It may therefore be advantageous to provide a sensor measuring the signal, which is to be damped or counteracted, and design the damping signal based on input from the sensor. This allows for the damping signal to be generated also in cases where the stimulation signal varies over time or is difficult to estimate or model. By such a feedback loop, a more flexible damping may be provided.

As mentioned above, the signals do not necessarily have to be formed of pulses or square waves. Figure 10b illustrates another (still simplified) example, wherein the signal originating from the stimulation signal is shaped as a sine wave, and wherein the damping signal has a corresponding shape and is phase shifted to counteract or cancel the stimulation signal. Other signal shapes are however equally possible, including square, triangle and sawtooth waves and combination thereof.

A further example is shown in figure 10c, in which the damping signal is configured to disturb or “scramble” the signal originating from the stimulation device 110 such that it has a reduced effect on tissue arranged remote from the electrode elements 112a of the stimulation device 110. The damping signal may for instance comprise a frequency which is higher than the frequency of the signal from the stimulation device 110, such that the resulting, superposed signal that reaches the individual tissue cells are less suitable for triggering a contraction of the smooth muscle tissue cells or a conveying of the stimulation signal by the nervous tissue cells. This is based on the observation that a stimulating signal may have a reduced impact on cells when the frequency is outside a certain interval. Put differently, the stimulation of tissue may be less efficient for higher frequencies, and the damping signal may therefore be applied to increase the frequency accordingly.

Figure 11 is a schematic outline of a device, or system, for treating a patient with hypertension. The system may comprise an implantable stimulation device 110 and, optionally, an implantable signal damping device 120, which may be similarly configured as the stimulation and signal damping devices discussed above in connection with the previous examples. The system may further comprise an implantable source of energy, or energy storage unit 130, for energizing the stimulation device 110 and the signal damping device 120 and providing the electrical energy required for generating the electrical stimulation signal and the electric damping signal. Further, the system may comprise a control unit or controller 150 configured to control the generation of the stimulation signal and/or the damping signal, and a sensor configured to generate input that can be used for generating the damping signal.

Any of the above elements, such as the energy storage unit 130, the sensor 140, and the controller 150, or parts thereof, may be configured to be attached to a tissue wall of the body by means of a holding device as discussed in connection figures 26-45.

The energy storage unit 130 may for instance be of a non-rechargeable type, such as a primary cell, or of a rechargeable type, such as a secondary cell. The energy storage unit 130 may be rechargeable by energy transmitted from outside the body, from an external energy storage unit, or be replaced by surgery when needed.

The controller 150 may comprise an electric pulse generator for generating electrical pulses to the stimulation signal and/or the damping signal. The controller 150 may be integrated with the energy storage unit 130 or provided as a separate, physically distinct unit which may be configured to be implanted in the body or operate from the outside of the body. In case of the latter, it may be advantageous to allow an external control unit to communicate wirelessly with the controller 150 for example by means of a communication unit of a more general controller (not shown). The external controller may for example be a wireless remote control, and the controller may in such cases advantageously comprise an internal signal transceiver configured to receive and transmit communication signals from/to an external signal transmitter. More detailed examples are disclosed in connection with figures 24a-f and 25.

In some examples, the controller 150 may be configured to generate a signal indicating a functional status of the source of energy 130, such as for instance a charge level or a temperature of the source of energy 130. Further, the control unit 150 may in some examples be configured to indicate a temperature of at least one of the stimulation device 110, the signal damping device 120 and tissue adjacent to the stimulation device 110 or the signal damping device 120. In some cases, the system comprises a sensor 140, which may be configured to sense a physical parameter of the body and/or the implantable device. The sensor may be similarly configured as the sensors discussed below in connection with figures 12a-d, 13a-b and 14. The sensor 140 may for example be employed to sense or detect a stretching or contraction of the outer wall of renal artery 20, thereby allowing for the vasoconstriction and vasodilation of the renal artery 20 to be monitored. The sensor 140 may in this example comprise a strain gauge configured to indicate a strain of the outer wall of the renal artery 20. In an example, the relaxation of the blood vessel may be verified by means of the sensor 140 and the stimulation device 110 controlled accordingly. The stimulation device 110 may for example modify the stimulation signal based on feedback from the sensor 140 pertaining to the muscular response to the stimulation signal, which advantageously may allow for the stimulation signal to be modified to improve or increase the vasodilation in the renal artery 20. In further examples, the sensor 140 may comprise a pressure sensor configured to generate a signal indicating a pressure in the renal artery 20. The signal indicating the pressure in the blood vessel may for instance be sent to the controller 150 and used as input for adjusting the electrical stimulation signal affecting the vasomotor tone of the smooth muscle tissue of the renal artery 20.

In further examples, the sensor 140 may be configured to generate a signal indicative of electrical properties of the signal propagating from the stimulation device 110, such as the signal propagating towards regions of the body which should not be stimulated by the stimulation signal. Examples of such regions may for instance include the aorta 22 and ganglia from which the nerves innervating the renal artery origin. The sensor 140 may for example include a voltage sensor and/or a current sensor and may be configured to deliver information to the controller 150 pertaining to for instance voltage, amplitude and frequency of signals propagating from the electrode elements 112a of the stimulation device 110.

The controller 150 may be configured to use this information to generate a damping signal which can be supplied to for instance the tissue of the renal artery, close to the bifurcation with the aorta, or at least reducing the tissue’s muscular response to the propagated stimulation signal. The sensor may for example be structurally integrated with the signal damping device 120, or provided as a separate, structurally distinct unit. In some examples, the sensor may comprise one or several electrode elements or electrical probes, which may be arranged to engage the nerve or muscular tissue through which the signal from the stimulation device passes.

In some examples, the sensor 140 may be configured to sense or detect action potentials that are being transmitted to the muscle tissue. The action potentials may be registered by the sensor 140 and information relating to the action potentials be transmitted to the controller 150. The controller 150 may use the received information when controlling the signal damping device 120 to reduce the effect of the electric stimulation signal on tissue to which the electrical stimulation signal has propagated. As mentioned above in connection with figure 11 it will be appreciated that any of the above embodiments, such as the arrangement disclosed in figure 4-8, may include a sensor configured to generate a signal indicative of a blood pressure (or vascular resistance) of the patient. Examples of such sensors will be described in the following with reference to figures 12-14. The various examples and embodiments of sensors described in the following may thus be combined with any of the above discloses systems and devices for causing electrically induced vasodilation of the renal artery, and the description of such systems and devices will therefore not be repeated in the following.

The inventive concept may utilize sensors of a transducer type, in which energy is converted from one form to another. The sensor may thus be configured to convert a pressure signal (measured directly in the blood or indirectly via an intermediate medium, such as the wall of the blood vessel) into for instance an electrical signal which thus may be considered to be a function of the pressure.

The sensor may be of a dynamic type, configured to capture or monitor the pressure over time and generate a signal indicating the pressure for each measurement point (or continuously, depending on sensor type). The control unit, to which the signal may be sent, may then analyses the signal and make the decision to initiate or stop the stimulation of the renal artery. Alternatively, the sensor may be of a switch type which is configured to turn on or off at a particular pressure. For example, the sensor may be configured to generate a trigger signal for blood pressures being above a certain threshold (or, in alternative configurations, for blood pressures being below a certain threshold). In such cases, the control unit may be configured to treat the signal as a trigger or ON signal, initiating the stimulation of the muscle tissue of the renal artery. In different words, the values of the signal from the sensor may either be (substantially) continuous (giving a substantially true representation of any changes in the measured quantity) or binary, indicating whether the measured quantity is above or below a given limit.

The sensor may be configured to measure the pressure relative to a reference pressure, such as perfect vacuum. This type of sensor may be referred to as an absolute pressure sensor. The sensor may also be a differential pressure sensor, configured to measure the difference between two pressures, such as the pressure inside the blood vessel compared to the pressure outside the blood vessel, or the atmospheric pressure. This type of sensor is sometimes referred to as a gauge pressure sensor.

The pressure sensor may be of a force collector type, using a force collector (such as a diaphragm, piston, bourdon type, or bellows) to measure strain (or deflection) due to applied force over an area (pressure). The sensor may for example utilize piezoelectric or piezoresistive effects to detect strain due to applied pressure or employ a variable capacitor technology to generate a signal as pressure deforms for instance a diaphragm. Pressure induced displacements of elements of the sensor (or parts of the patient’s body) may also be measured by means of changes in inductance, Hall effect, eddy currents and the like. In further examples, electrically conductive strain gauges may be attached to an area which moves due to applied pressure and used for generating a signal indicative of the movement of the area. In yet further examples the sensor may operate based on an optical technique, including the use of the physical change of an optical fiber to detect strain due to applied pressure or optical coupling. Alternatively, or additionally, changes in the blood flow may be measured using optical methods, involving for instance radar or doppler effects, or by monitoring the optical coupling efficiency of light passing through the blood vessel. These principles may utilize the observations that light may behave differently depending on the pressure in the blood. Non-limiting details and examples will be discussed in further detail in the following.

The sensor may be arranged at the renal artery, preferably the same renal artery as the one to which the electrical muscle tissue stimulation is applied. A merit of this arrangement is that the sensor may deliver a signal indicating pressure changes resulting from vasodilation of the renal artery and can therefore be considered to provide a more direct feedback to the stimulation process. Put differently, a control loop may be achieved, which utilizes feedback data that are obtained from the same blood vessel as the one that is being electrically stimulated.

Alternatively, or additionally, a sensor may be arranged elsewhere, i.e., remote from the renal artery which is electrically stimulated. One or more sensors may hence be arranged at a blood vessel in another part of the patient’s body, such as the aorta, or an artery in the abdomen or a limb of the body, to generate a signal indicative of a systemic blood pressure of the patient. It may be advantageous to arrange the sensor at a position which is easier to access than the renal artery, allowing for the sensor to be implanted in a less complicated and invasive surgical procedure.

The sensor may be configured for long-term implantation, or permanent implantation, in which the sensor is expected to be operating for several months or years without having to be replaced or physically accessed. This allows for the sensor to be operable continuously during the operation of the stimulation device. Alternatively, the sensor may be configured for a temporal use, for instance during a shorter period in which the stimulation device is calibrated. The sensor may thus be implanted for a few hours, days or weeks, for example during setup or calibration of the stimulation device, whereafter the sensor may be removed.

According to some embodiments, the sensor may be arranged to measure the pressure directly in the blood vessel. This may for example be achieved by arranging a probe inside the blood vessel, such as the renal artery, or another artery such as the radial artery, femoral, dorsalis pedis or brachial artery. The probe may thus be employed to generate a signal indicative of the pressure acting on the probe, thereby giving an indication of the blood pressure.

According to some embodiments, the pressure sensor may be arranged at an outer wall of the blood vessel of the patient. The sensor may for example be formed as a cuff at least partly enclosing the blood vessel or be arranged to abut at least a portion of the outer wall. By this arrangement, the sensor may be configured to measure pulse waves transmitted by the blood into the wall of the blood vessel. The pulse waves transmitted through the wall may be converted into a signal, such as an electrical signal, by means of a strain gauge reacting on a strain induced in the wall portion by the pressure pulses, or by means of a contact pressure sensor configured to react or monitor a contact pressure between the outer wall portion and the sensor. A pulse wave, transmitted through the blood, may hence give rise to an increased pressing force between the outer wall of the blood vessel and the pressure sensor, which in turn may be configured to convert the increased pressing force into a signal indicative of the pressure according to a technique mentioned above.

According to some embodiments, the sensor may comprise a light source configured to input light into the blood, such as through the wall portion of the blood vessel, and a light sensor configured to receive light transmitted from the light source. The light sensor may for instance be arranged outside the blood vessel, at a side opposing the light source. This may be referred to as an optical sensor, which in some examples may base the pressure measurements on a light coupling efficiency through the blood vessel. The light coupling efficiency may for instance be a function of a contact pressure between the light source and the wall portion of the blood vessel, and/or a contact pressure between the light sensor and a wall portion of the blood vessel and may therefore be used to indicate a characteristic of the pressure pulse generated by the heartbeats. Optical methods may also be used to measure a deflection, or movement, of a wall portion of the blood vessel in response to the pressure pulse wave travelling through the blood vessel. Such an optical method may for instance utilize the doppler radar effect to monitor a pulse wave causing a movement in the wall portion of the blood vessel.

According to some embodiments, the sensor may operate according to the auscultatory principle, in which a constrictive element, or constriction device, is placed around the blood vessel and operated to constrict the blood vessel until is occluded and the blood flow therein stopped. The constriction may then be gradually released, and the constrictive pressure registered as a function of the returning blood flow. In an example, the constriction device is used in an oscillometric method, in which oscillations in the constrictive pressure caused by oscillations in the blood flow, i.e., the pulse, are measured. The constriction device may for instance be operated to a pressure initially exceeding the systolic arterial pressure and then reduce to below the diastolic pressure. When blood flow is substantially nil (constrictive pressure exceeding systolic pressure) or substantially unimpeded (constrictive pressure below diastolic pressure), the constrictive pressure may be essentially constant. When blood flow is present, but restricted, the constrictive pressure, which may be monitored by the sensor, may vary periodically in synchrony with the cyclic expansion and contraction of the blood vessel, i.e., it will oscillate. Over the release period, in which the constrictive pressure is reduced, the recorded pressure waveform may form a signal from which the oscillometric pulses may be extracted using a bandpass fdter. The extracted oscillometric pulses may form a signal referred to as the oscillometric waveform, OMW, which can be analyzed and processed to estimate the systolic, diastolic and mean arterial pressure.

The sensor may in some examples be configured to generate a signal indicative of a vascular resistance of a blood vessel of the patient. As the blood pressure may be understood as a function of (inter alia) the vascular resistance, this measure may be used when estimating the blood pressure. The sensor may for instance be configured to measure a flow of blood in the blood vessel, to measure a vasodilation or vasoconstriction of the blood vessel, and/or a size of the blood vessel (such as inner or outer diameter or cross-sectional size). The blood flow through the blood vessel may for instance be monitored by means of a light coupling method as indicated above, where the composition of the blood is monitored to estimate a flow of the blood. This may for example involve observing or estimating a number of red blood cells passing a certain region or volume of the blood cell per unit of time. An increase in blood flow may indicate a reduced vascular resistance, whereas a reduced blood flow may indicate an increased vascular resistance.

Various examples of sensors, which all may operate as outlined above, will now be discussed with reference to figures 12a-d, 13a-b and 14. It will be appreciated that the below sensors may be combined with any of the above arrangements disclosed in for instance figures 4-8 for causing electrically induced vasodilation of the renal artery. The description of such systems and devices will not be repeated in the following.

Figures 12a-d show examples of sensors 140 for generating a signal indicative of a blood pressure, a vascular flow, or a vascular resistance, in a blood vessel 20 of a patient. The blood vessel 20 may for instance be a renal artery of the patient, or another artery such as the radial artery, femoral, dorsalis pedis or brachial artery. In some examples the blood vessel may be a vein. The sensors 140 may be for instance be configured to convert a pressure signal into another signal, such as an electrical signal, indicative of the pressure in the blood vessel 20. This signal may be transmitted to a control unit (not shown) configured to control an operation of a stimulation device as previously discussed in the present disclosure. The transmission between the sensor 140 and the control unit may take place over a wired or wireless communication channel, which for example may be formed of one or more electrical leads interconnecting the control unit and the sensor.

Figure 12a shows an example of a sensor 140 configured to be arranged to measure the pressure directly in the blood vessel 20. The sensor 140 may hence comprise a probe 142 configured to penetrate a wall portion of the blood vessel 20 and be arranged within the lumen, or blood passageway defined by the interior of the blood vessel 20. The sensor may further comprise a body part configured to be arranged on the outside of the blood vessel 20. The body part may for example be configured to be attached or secured to the outer surface of the wall. The probe 142 may be provided at an underside of the body part so as to allow the probe to extend into the interior of the blood vessel 20 when the body part is attached to the wall part of the blood vessel 20. Figure 12b shows an example of an optical sensor 140 for measuring blood pressure pulses transmitted through the walls of the blood vessel 20. The sensor 140 may comprise a light source 141 and a light sensor 143 configured to be arranged on opposite sides of the blood vessel such that light from the light source 141 can be transmitted through the blood vessel 20 and the blood flowing therethrough. In an example, the light is transmitted from the light source 141 through a light transmitting body 141’ towards the blood vessel 20. The light transmitting body 141’, or light guide 141’, may comprise a convex surface being curved towards the outer wall of the blood vessel 20. The curved surface may be arranged to abut the outer wall, such that a contact area is provided at the interface between the blood vessel 20 and the light transmitting body 141’ . It has been observed that the size of the contact area may vary with the contact force between the blood vessel 20 and the light transmitting body 141’ (i.e., the force with which the surfaces of the blood vessel 20 and the light transmitting body 141’ abuts each other), such that an increased contact area is achieved when the wall of the blood vessel 20 is pushed against the light transmitting body 141’ and a reduced contact area is achieved when the contact force between the wall of the blood vessel and the light transmitting body 141’ is reduced. By arranging the sensor 140 such that it abuts the outside of the wall of the blood vessel 20, the contact area between the two may be caused to vary in size with the pressure pulse waves transmitted through the blood vessel 20. It has further been observed that the light coupling efficiency through the blood vessel 20, for example measured as the percentage of the light generated by the light source 141 that is registered by the sensor 143, may vary with the size of the contact area between the light transmitting body 141’ and the wall of the blood vessel 20. Hence, the variations in the signal at the light sensor 143 may be analyzed to calculate a corresponding variation in contact pressure and thus get an indication of the pressure in the blood vessel 20. As indicated in the present figure, there may alternatively, or additionally, be provided a light transmitting body 143’ arranged at the light sensor side, which may be configured and function in a similar way as described above.

The light transmitting body 141’, 143 ’ may in some examples be rigid so that the variations in contact area are caused by the wall of the blood vessel 20 deforming rather than the light transmitting body 141’, 143’ deforming. In further examples the light transmitting body 141’, 143’ may be flexible, allowing it to deform with an applied contact force between the blood vessel and the light transmitting body 141’, 143’.

The sensor 140 may comprise a holding structure, such as a cuff 144, configured to at least partly enclose the blood vessel 20 and push the light transmitting body (or bodies) 141’, 143 ’ against the outer wall of the blood vessel 20. The holding structure may be similarly configured as the one disclosed in connection with figures 5-7.

Another embodiment, which may be similar to the one illustrated in figure 12b, may operate based on acoustic waves instead of optical principles. Such a sensor 140 may hence comprise an acoustic transducer instead of the light source 141 and an acoustic sensor instead of the light sensor 143. Still, the coupling efficiency through the blood vessel may be determined as a function of a varying contact area between the sensor 140 and the outer wall of the blood vessel 20, allowing for a signal to be generated which is indicative of the pulse waves travelling through the blood vessel 20. Similar to the optic version above, the coupling efficiency of the sound may increase with increasing contact area and decrease with decreasing contact area, as the pulse wave passes by.

Figure 12c show an example of a sensor 140 operating by means of a doppler radar principle, in which a beam of electromagnetic (or acoustic) waves is sent from a transmitter 147 and reflected from the outer wall of the blood vessel. Assuming that the wall moves slightly back and forth along a radial direction of the vessel as the pulse wave passes through the vessel, the movement may be determined based on a slight change in frequency of the reflected waves. These changes may be observed by the transmitter 147 and used as a basis for generating a signal indicative of the pressure in the blood vessel 20.

Figure 12d shows a further example of a sensor 140, which may be configured as a strain sensor generating a signal in response to strain induced in the wall by the pressure variations caused by the patient’s pulse beats. The sensor 140 may for example operate based on a capacitive principle, in which the capacitance between two electrodes 145, 146 may vary with varying structural dimensions between the electrodes 145, 146. The electrodes 145, 146 may for instance comprise a first and a second interdigitated finger electrodes, having a separation which may vary with induced strain in the wall of the blood vessel 20. An increased separation between the electrodes 145, 146 may be observed as a reduced capacitance, indicating an increased strain in the wall, whereas a reduced separation may be observed as an increased capacitance, indicating a reduced strain in the wall. Further, the strain sensor 140 may be used to measure a vasodilation and/or vasoconstriction in the blood vessel 20.

Figures 13a and b show an example of a sensor 140 formed of a constriction device configured to at least partly constrict, or at least push against the outer wall of, the blood vessel 20. The sensor 140 in some examples operate according to the auscultatory principle, in which the blood pressure is measured by constricting the blood vessel until it is occluded, and the blood flow substantially stopped, and in other examples according to an oscillometric method in which oscillations in a constrictive pressure applied by the constriction device (which hence not necessarily is operated to fully close the blood flow passageway) are measured.

The constriction device 140 in figure 13a may hence be configured to constrict a wall portion of the of a blood vessel 20, such as the renal artery or another artery which may be more easily accessed for the implantation procedure. The constriction device 116 may comprise a surrounding structure, or support structure, having a periphery arranged to surround the blood vessel 20 when implanted. The surrounding structure may be configured to support one or several constriction elements configured to expand inwards, towards an opposing wall of the surrounding structure, to abut the outer wall of the blood vessel 20 and thereby allowing pressure pulses induced by the blood pressure in the vessel to be transmitted into the constriction elements. Further, in some examples, the constriction elements may be operable to close the passage through the blood vessel to allow the blood pressure to be measured using the auscultatory principle.

In the example shown in the present figure, the surrounding structure comprises two support elements 64a, 64b connected to each other for forming the surrounding structure. The first support element 64a may be configured to support a first operable hydraulic constriction element 601a and a second operable hydraulic constriction element 601b. The second support element 604b may be configured to support a third operable hydraulic constriction element 601c and a fourth operable hydraulic constriction element 60 Id. The first, second, third and fourth operable hydraulic constriction elements lOla-d may be configured to constrict the blood vessel 20 for restricting the flow and configured to release the constriction when so desired.

The first and second support elements 64a, 64b each comprises a curvature C adapted to follow the curvature of the portion of the blood vessel 20 at which the pressure sensor 140 is arranged, such that the pressure sensor 140 snuggly fits around the blood vessel 20 and the distance which the operable hydraulic constriction elements 604a-d needs to expand to abut or even constrict the blood vessel 20 is reduced.

The first and second support elements 64a, 64b may be hingedly connected to each other such that a periphery of the surrounding structure is possible to open, thereby allowing the surrounding structure to be placed around the blood vessel 20. A first end of the first and second support elements 64a, 64b may comprise a hinge 66, whereas the other ends of the first and second support elements 64a, 64b may comprise portions of a locking member 67’, 67”, each comprising protruding snap-lock locking members materially integrated in the first and second support elements 64a, 64b and configured to be snapped together for closing the periphery of the surrounding structure, thereby allowing the surrounding structure to partially or completely encircle the blood vessel 20.

The constriction elements may be hydraulically connected to a pressure sensor configured to register pressure pulses induced in the constriction elements by the pressure pulses travelling through the blood vessel. The registered pressure pulses may then be converted in to a signal that is indicative of the blood pressure in the blood vessel and transmitted to the control unit as discussed above.

In the embodiment shown in figure 13a, each of the first and second support elements 64a, 64b comprises fluid conduits 609a-d partially integrated in the support elements 64a, 64b. In the first support element 64a a first conduit 609a comprises a first portion in the form of a first tubing which enters a tubing fixation portion 65a fixated to, or materially integrated with, the first support element 64a. In the tubing fixation portion 65a the fluid conduit 109a is transferred into a first integrated channel 23a in the first support element 24a. The first support element 64a may comprise an inner surface 68a which configured to be oriented to face the wall of the blood vessel 20, when the sensor 140 is implanted. The inner surface 68a of the first support element 64a may comprise a fixation surface for fixating the first and second operable hydraulic constriction elements 601a, 601b. The fixation surface also comprises an outlet from the first integrated channel 63a into the first operable hydraulic constriction element 601a, such that fluid can be transferred from the first tubing to the first integrated channel 63a and into the first operable hydraulic constriction element 601a for expanding the first operable hydraulic constriction element 601a.

A second tubing of the second fluid conduit 609b may also enter the tubing fixation portion 65a fixated to, or materially integrated with, the first support element 64a. In the tubing fixation portion 65a the second fluid conduit 609b is transferred into a second integrated channel 63b in the first support element 64a. The fixation surface also comprises an outlet from the second integrated channel 63b into the second operable hydraulic constriction element 601b, such that fluid can be transferred from the second tubing to the second integrated channel 63b and into the second operable hydraulic constriction element 601b for expanding the second operable hydraulic constriction element 601b.

The second support element 64b may, similar to the first support element 64a, comprise a fixation surface for fixating a third and fourth operable hydraulic constriction element 601c, 60 Id operated by fluid supplied by third and fourth fluid conduits 609c, 609d as illustrated above with reference to the first and second constriction elements 601a, 601b.

The tubing portion of the fluid conduits 109a-d is preferably made from a biocompatible material such as silicone and/or polyurethane.

Integrating the fluid conduit(s) in the support element(s) enables the fluid entry to the operable hydraulic constriction elements 601a-d to be protected and encapsulated by the support element(s) which reduces the space occupied by the constriction device 116. Further, it may reduce the amount of protruding portions, thereby reducing the risk of damaging the tissue of the blood vessel 20 around which it is implanted.

The first, second, third and fourth operable hydraulic constriction element 601a-d may be connected to a shared hydraulic system, such that the abutment against the wall of the blood vessel as well as any potential constriction of the blood flow passageway may be regulated by pumping the hydraulic fluid to and from the constriction elements 601a-d. Alternatively, one or several of the hydraulic constriction elements 601a-d are individually controllable, such that for instance the first and third hydraulic construction elements 601a, 601c share a first hydraulic system and the second and fourth hydraulic constriction elements 601b, 60 Id share a second hydraulic system, separate from the first hydraulic system. This advantageously allows for the first and third constriction elements 601a, 601c to be inflated at the same time as the second and fourth constrictions elements 601b, 60 Id are deflated. Further, one or several of the hydraulic constriction elements may be connected to a hydraulic pressure sensor for measuring pressure variations in the constriction element(s) caused by the pulse waves in the blood vessel 20.

The first and third constriction elements 601a, 601c may have a respective volume that is larger than a respective volume of the second and fourth constriction elements 601b, 60 Id. In the embodiment of figures 13a and b, the first and third constriction elements 601a, 601c may have a respective volume that is more than 1.5 times larger than the respective volumes of the second and fourth constriction elements 601b, 60 Id. However, it is also conceivable that the first and third constriction elements 601a, 601c have a respective volume that is more than 2 times as large as the volume of the second and fourth constriction elements 601b, 60 Id.

The sensors shown in figures 12a-d and 13a-b may be connected to, or form part of, a stimulation device 110 for causing electrically induced vasodilation in a renal artery of a patient. As example of such an implementation is illustrated in figure 14, wherein a stimulation device 110 similar to the one discussed with reference to figure 4 is implanted together with a sensor 140 similar to the one disclosed in connection with figures 13a-b. As shown in figure 14, both the stimulation device 110 and the sensor 140 may be arranged to act on the renal artery 20 of the patient, with the stimulation device 110 configured to electrically stimulate smooth muscle tissue of a wall portion of the renal artery 20 and the sensor 140 arranged as a cuff at least partly enclosing the renal artery 20. The cuff comprises at least two inflatable elements arranged to abut the outer wall of the renal artery. The inflatable elements are connected to an operation device 148 for varying a contact pressure between the inflatable elements and the renal artery. The operation device 148 may for instance be a hydraulic device configured to move a hydraulic fluid to and from the inflatable elements to adjust their inflation. The sensor 140 may be communicatively connected to a control unit, or controller 114, of the stimulation device 110 to provide the control unit 114 with a signal indicative of a pressure in the renal artery 20. This signal may be used by the control unit 114 for controlling the stimulation and hence the vasodilation of the renal artery 20.

In the following, a detailed description will be given of a technology for electrically stimulating tissue, such as the above renal artery 20, for exercising the tissue and thereby improving the conditions for long term implantation. The body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body. Exposing tissue to long-term engagement with, or pressure from, an implant may deprive the cells of oxygen and nutrients, which may lead to deterioration of the tissue, atrophy and eventually necrosis. The interaction between the implant and the tissue may also result in fibrosis, in which the implant becomes at least partially encapsulated in fibrous tissue. It is therefore desirable to stimulate or exercise the cells to stimulate blood flow and increase tolerance of the tissue for pressure from the implant.

In the following, the use of electric signals for exercising tissue to improve the conditions for long term implantation will be described. It should be noted that there may be a difference between the electric stimulation signal (as well as the signal damping signal) discussed above in connection with for instance figures 4-7, and the electric signal delivered for improving long term implantation conditions. While the former signal may be specifically adapted to trigger a muscular response for inducing vasodilation, the latter may be provided with the primary aim of preventing deterioration of the tissue and eventually necrosis of tissue of the renal artery. Preventing or reducing tissue deterioration does not necessarily require a stimulation causing the same degree of response as needed for inducing vasodilation. On the contrary, it may be advantageous to deliver an electric signal inducing a stimulation of the tissue stimulation (i.e., motoric response) without substantially affecting the flow resistance in the blood vessel. The “exercising” of the tissue to prevent deterioration may hence be combined with the stimulating causing vasodilation, and preferably cycled such that exercising cycles are performed between vasodilation cycles. The exercising, which thus may differ in effect or muscular response from the vasodilation, may be performed by delivering an exercising signal to the tissue via the electrode arrangements of the stimulation devices and/or damping devices discussed with reference to e.g. figures 4-7. It may be particularly advantageous to combine the exercising of the muscle tissue with medical devices comprising support structures, such as the cuff 116 shown in figures 5 and 7 and the sensors figures 12a-d, 13a-b and 14. As these may form a relatively large contact surface with the tissue against which they are arranged (compared to the electrodes attachments shown in e.g. figure 4), there is an increased risk for a negative impact on the health of the tissue.

The electrical electrode arrangement and exercising methods described in the following may thus be implemented in any of the embodiments of the stimulation devices, signal damping devices, and sensors described above for the purpose of exercising the tissue which is in contact with such medical devices or implants.

Muscle tissue is generally formed of muscle cells that are joined together in tissue that can be either striated or smooth, depending on the presence or absence, respectively, of organized, regularly repeated arrangements of myofibrillar contractile proteins called myofilaments. Striated muscle tissue is further classified as either skeletal or cardiac muscle tissue. Skeletal muscle tissue is typically subject to conscious control and anchored by tendons to bone. Cardiac muscle tissue is typically found in the heart and not subject to voluntary control. A third type of muscle tissue is the so-called smooth muscle tissue, which is typically neither striated in structure nor under voluntary control. Smooth muscle tissue can be found in the wall of the renal artery 20, as previously discussed.

The contraction of the muscle tissue may be activated both through the interaction of the nervous system as well as by hormones. The different muscle tissue types may vary in their response to neurotransmitters and endocrine substances depending on muscle type and the exact location of the muscle. A nerve is an enclosed bundle of nerve fibers called axons, which are extensions of individual nerve cells or neurons. The axons are electrically excitable, due to maintenance of voltage gradients across their membranes, and provide a common pathway for the electrochemical nerve impulses called action potentials. An action potential may be understood as an all-or-nothing electrochemical pulse generated by the axon if the voltage across the membrane changes by a large enough amount over a short interval. The action potentials travel from one neuron to another by crossing a synapse, where the message is converted from electrical to chemical and then back to electrical.

The distal terminations of an axon are called axon terminals and comprise synaptic vesicles storing neurotransmitters. The axonal terminals are specialized to release the neurotransmitters into an interface or junction between the axon and the muscle cell. The released neurotransmitter binds to a receptor on the cell membrane of the muscle cell for a short period of time before it is dissociated and hydrolyzed by an enzyme located in the synapse. This enzyme quickly reduces the stimulus to the muscle, which allows the degree and timing of muscular contraction to be regulated delicately.

The action potential in a normal skeletal muscle cell is similar to the action potential in neurons and is typically about -90 mV. Upon activation, the intrinsic sodium/potassium channel of the cell membrane is opened, causing sodium to rush in and potassium to trickle out. As a result, the cell membrane reverses polarity and its voltage quickly jumps from the resting membrane potential of -90 mV to as high as +75 mV as sodium enters. The muscle action potential lasts roughly 2-4 ms, the absolute refractory period is roughly 1-3 ms, and the conduction velocity along the muscle is roughly 5 m/s. This change in polarity causes in turn the muscle cell to contract.

The contraction and relaxation of smooth muscle cells is typically influenced by multiple inputs such as spontaneous electrical activity, neural and hormonal inputs, local changes in chemical composition, and stretch. This in contrast to the contractile activity of skeletal and cardiac muscle cells, which may rely on a single neural input. Some types of smooth muscle cells are able to generate their own action potentials spontaneously, which usually occur following a pacemaker potential or a slow wave potential. However, the rate and strength of the contractions can be modulated by external input from the autonomic nervous system. Autonomic neurons may comprise a series of axon-like swellings, called varicosities, forming motor units through the smooth muscle tissue. The varicosities comprise vesicles with neurotransmitters for transmitting the signal to the muscle cell. The autonomic neurons may for example trigger a muscular response in the wall of the renal artery, leading to a contraction or relaxation affecting a flow resistance in the renal artery. Sympathetic stimulation (norepinephrine) has been observed to constrict some blood vessels and dilate others, depending on whether the target cells (i.e., the smooth muscle cells) has alpha- or beta-adrenergic receptors. The sympathetic nervous system can also constrict or dilate vessels just by changing firing frequency of the action potentials. An increased firing frequency may cause the smooth muscle to contract and constrict the vessel, whereas a reduced firing frequency may cause the smooth muscle cells to relax, allowing blood pressure to dilate the vessel.

The muscle cells described above, i.e., the cardiac, skeletal and smooth muscle cells are known to react to external stimuli, such as electrical stimuli applied by electrodes. A distinction can be made between stimulation transmitted by a nerve and direct electrical stimulation of the muscle tissue. In case of stimulation via a nerve, an electrical signal may be provided to the nerve at a location distant from the actual muscle tissue, or at the muscle tissue, depending on the accessibility and extension of the nerve in the body. The stimulation devices 110, 120 as well as the signal damping devices described above in connection with for instance figures 4-7 may employ both a direct stimulation of the muscle tissue and stimulation transmitted via a nerve to affect the vasomotor tone.

In case of direct stimulation of the muscle tissue, the electrical signal may be provided to the muscle cells by an electrode arranged in direct or close contact with the cells of the renal artery 20. However, other tissue such as fibrous tissue and nerves may of course be present at the interface between the electrode and the muscle tissue, which may result in the other tissue being subject to the electrical stimulation as well.

In the context of the present application, the electrical stimulation discussed in connection with the various aspects and embodiments may be provided to the tissue in direct or indirect contact with the implantable medical device. Preferably, the electrical stimulation is provided by one or several electrode elements arranged at the interface or contact surface between the implantable constriction device and the tissue. Thus, the electrical stimulation for exercising the tissue may, in terms of the present disclosure, be considered as a direct stimulation of the tissue. Particularly when contrasted to stimulation transmitted over a distance by a nerve, which may be referred to as an indirect stimulation or nerve stimulation.

In the following, the interaction between an implanted electrode element and tissue of the body will be discussed. This discussion may be applied both to electrical stimulation for inducing vasodilation of the renal artery 20 as well as signal damping, electric sensing and electrical stimulation for exercising the tissue to reduce effects of deterioration caused by presence of a long term implanted medical device.

It has been observed that the interaction between an implanted electrode element and tissue of the body is to a large extent determined by the properties at the junction between the tissue and the electrode element. The active electrically conducting surface of the electrode element (in the following referred to as “metal”, even though other materials is equally conceivable) can either be uncoated resulting in a metal-tissue interface (such as disclosed in figure 9c), or insulated with some type of dielectric material (such as disclosed in figure 9d). The uncoated metal surface of the electrode element may also be referred to as a bare electrode. The interface between the electrode element and the tissue may influence the behavior of the electrode element, since the electrical interaction with the tissue is transmitted via this interface. In the biological medium surrounding the electrode element, such as the actual tissue and any electrolyte that may be present in the junction, the current is carried by charged ions, while in the material of the electrode element the current is carried by electrons. Thus, in order for a continuous current to flow, there needs to be some type of mechanism to transfer charge between these two carriers.

In some examples, the electrode element may be a bare electrode wherein the metal may be exposed to the surrounding biological medium when implanted in, or at the muscle tissue that is to be stimulated. In this case there may be a charge transfer at a metal-electrolyte interface between the electrode element and the tissue. Due to the natural strive for thermodynamic equilibrium between the metal and the electrolyte, a voltage may be established across the interface which in turn may cause an attraction and ordering of ions from the electrolyte. This layer of charged ions at the metal surface may be referred to as a “double layer” and may physically account for some of the electrode capacitance.

Hence, both capacitive faradaic processes may take place at the electrode element. In a faradaic process, a transfer of charged particles across the metal-electrolyte interface may be considered as the predominant current transfer mechanism. Thus, in a faradaic process, after applying a constant current, the electrode charge, voltage and composition tend to go to constant values. Instead, in a capacitive (non-faradaic) process charge is progressively stored at the metal surface and the current transfer is generally limited to the amount which can be passed by charging the interface.

In some examples, the electrode element may comprise a bare electrode portion, i.e., an electrode having an uncoated surface portion facing the tissue such that a conductor-tissue interface is provided between the electrode element and the tissue when the electrode element is implanted. This allows for the electric signal to be transmitted to the tissue by means of a predominantly faradaic charge transfer process. A bare electrode may be advantageous from a power consumption perspective, since a faradaic process tend to be more efficient than a capacitive charge transfer process. Hence, a bare electrode may be used to increase the current transferred to the tissue for a given power consumption.

In some examples, the electrode element may comprise a portion that is at least partly covered by a dielectric material so as to form a dielectric-tissue interface with the muscle tissue when the electrode is implanted. This type of electrode element allows for a predominantly capacitive, or non-faradaic, transfer of the electric signal to the muscle tissue. This may be advantageous over the predominantly faradaic process associated with bare electrodes, since faradaic charge transfer may be associated with several problems. Example of problems associated with faradaic charge transfer include undesirable chemical reactions such as metal oxidation, electrolysis of water, oxidation of saline, and oxidation of organics. Electrolysis of water may be damaging since it produces gases. Oxidation of saline can produce many different compounds, some of which are toxic. Oxidation of the metal may release metal ions and salts into the tissue which may be dangerous. Finally, oxidation of organics in a situation with an electrode element directly stimulating tissue may generate chemical products that are toxic.

These problems may be alleviated if the charge transfer by faradaic mechanisms is reduced, which may be achieved by using an electrode at least partly covered by a dielectric material. Preferably, the dielectric material is chosen to have as high capacitance as possible, restricting the currents flowing through the interface to a predominantly capacitive nature.

Several types of electrode elements can be combined with the present disclosure. The electrode element can for example be a plate electrode as indicated in figure 9a, comprising a plateshaped active part forming the interface with the tissue. In other examples, the electrode may be a wire electrode as indicated in figure 9b, formed of a conducting wire that can be brought in electrical contact with the tissue. Further examples may include needle- or pin-shaped electrodes as indicated in figure 8c and d, having a point at the end which can be attached to or inserted in the muscle tissue. The electrodes may for example be encased in epoxy for electrical isolation and protection and comprise gold wires or contact pads for contacting the muscle tissue.

Preferably, the electrode may be arranged to transmit the electrical signal to the portions of the tissue that is affected, or risks to be affected, by mechanical forces exerted by the medical implant. Thus, the electrode element may be considered to be arranged between the implanted device and the tissue against which the device is arranged to rest when implanted.

During operation of the medical device, or the electrode arrangement, the electric signal may cause the muscle cells to contract and relax repeatedly. This action of the cells may be referred to as exercise and may have a positive impact in terms of preventing deterioration and damage of the tissue. Further, the exercise may help increasing tolerance of the tissue for pressure and mechanical forces generated by the medical implant. The extent or amplitude of the contraction may however be reduced to a level which do not risk to substantially affect the flow resistance in the renal artery 20. The contraction and relaxation induced for exercising purposes may thus be less than the vasodilation induced for the purpose of affecting the blood pressure. Alternatively, or additionally the exercise may involve contraction and relaxation at a relatively high frequency, hindering the blood vessel to contract to a degree that affects the vascular resistance in the vessel before it is relaxed again.

The electrical signal for exercising the tissue may be generated by a controller, such as the control unit 150 discussed above in connection with figure 11. The controller 150 may be configured to control the electrical stimulation such that the tissue is stimulated by a series of electrical pulses. The pulses may comprise a pulse of a first polarity followed by a pulse of a second, reversed polarity, and the pulsed electrical stimulation signal generated comprises a pulse frequency of 0.01-150 Hz. In an example, the electrical stimulation signal comprises a pulse duration of 0.01-100 ms and a pulse amplitude of 1-15 mA. Example characteristics of electric signals for exercising the tissue is discussed below with reference to figures 15 and 16.

The controller may be configured to receive input from a wireless remote control, directly or via a receiver of the implantable controller, for controlling the stimulation or for programming a stimulation routine for exercising the muscle tissue to improve the conditions for long term implantation of the implantable medical device. The programming of a stimulation routine could for example be the programming of the frequency of the stimulation, or the current and/or voltage of the stimulation.

It will be appreciated that both faradaic and capacitive mechanisms may be present at the same time, irrespectively of the type of electrode used and the type of stimulation provided (i.e., for the purpose of vasoconstriction/vasodilation, signal damping, or for the purpose of exercising the tissue). Thus, capacitive charge transfer may be present also for a bare electrode forming a metaltissue interface, and faradaic charge transfer may be present also for a coated electrode forming a dielectric-tissue interface. It has been found that the faradaic portion of the current delivered to the muscle tissue can be reduced or even eliminated by reducing the duration of the pulses of the electric signal. Reducing the pulse duration has turned out to be an efficient way of increasing the portion of the signal which can be passed through the interface as a capacitive current, rather than by a faradaic current. As a result, shorter pulses may produce less electrode and tissue damage.

The capacitive portion of the current may further be increased, relative to the faradaic portion, by reducing the amplitude of the current pulses of the electrical signal. Reducing the current may reduce or suppress the chemical reactions at the interface between the electrode and the tissue, thereby reducing potential damage that may be caused by compounds and ions generated by such reactions.

In one example, the electrical stimulation may be controlled in such a manner that a positive pulse of the electrical signal is followed by a negative pulse (or, put differently, a pulse of a first polarity being followed by a pulse of a second, reversed polarity), preferably of the same amplitude and/or duration. Advantageously, the subsequent negative (or reversed) pulse may be used to reverse or at least moderate chemical reactions or changes taking place in the interface in response to the first, positive pulse. By generating a reversed pulse, the risk of deterioration of the electrode and/or the tissue at the interface between the electrode and the muscle tissue may be reduced.

Figure 15 shows an example of a pulsed electrical signal to be applied to an electrode for electrically stimulating muscle tissue via an electrode-tissue interface, thereby exercising the muscle tissue, as discussed above. The electrical signal may be generated by a controller arranged outside the body or implanted in the body (as described with reference to figure 11). The characteristics of the electrical signal may be selected and varied determined on the electrical and properties at the electrode-tissue interface and on the actual response of the tissue. The electrical stimulation delivered to the muscle cells may depend on several factors, such as the configuration and placement of the electrode element at the tissue, the presence of fibrous material at the interface, the composition of the electrolyte in the interface, accumulation of non-conducting material on the electrode surfaces, etcetera. It is therefore suggested that the characteristics of the electric signal, as shown in the present figure, be selected and varied based on an observed or estimated response from the stimulated tissue.

In the present example, the electrical signal is a pulsed signal comprising square waves PL1, PL2, PL3, PL4. However, other shapes of the pulses may be employed as well. The pulse signal may be periodic, as shown, or may be intermittent (i.e., multiple series of pulses separated by periods of no pulses). The pulses may have an amplitude A, which may be measured in volts, ampere or the like. Each of the pulses of the signal may have a pulse width D. Likewise, if the signal is periodic, the pulse signal may have a period F that corresponds to a frequency of the signal. Further, the pulses may be either positive or negative in relation to a reference.

The pulse frequency may for example he within the range of 0.01-150 hertz. More specifically, the pulse frequency may he within at least one of the ranges of 0.1-1 Hz, 1-10 Hz, 10- 50 Hz and 50-150 Hz. It has been observed that relatively low pulse frequencies may be employed to imitate or enhance the slow wave potential associated with pacemaker cells of the smooth muscle tissue. Thus, it may be advantageous to use relatively low pulse frequencies, such as 0.01- 0.1 Hz or frequencies below 1 Hz or a few Hz for such applications.

The pulse duration may for example lie within the range of 0.01-100 milliseconds, such as 0.1-20 milliseconds (ms), and preferably such as 1-5 ms. The natural muscle action potential has in some studies been observed to last about 2-4 ms, so it may be advantageous to use a pulse duration imitating that range.

The amplitude may for example lie within the range of 1-15 milliamperes (mA), such as 0.5-5 mA in which range a particularly good muscle contraction response has been observed in some studies.

In a preferred, specific example the electrical stimulation may hence be performed using a pulsed signal having a pulse frequency of 10 Hz, a pulse duration of 3 ms and an amplitude of 3 mA.

Fig. 16 shows an example of a pulsed signal, comprising build-up period XI, in which the amplitude is gradually increasing, a stimulation period X2 during which the muscle tissue is exposed to a contracting stimulation signal, a ramp down period X3 in which the amplitude is gradually decreasing, and a stimulation pause X4 before a new build-up period is initiated. The build-up period may for example be 0.01-2 seconds, the stimulation period 1-60 seconds, the rampdown period 0.01-2 seconds, and the stimulation pause 0.01-60 seconds. The pulse frequency may for example be 1-50 Hz, the pulse duration 0.1-10 milliseconds and the amplitude during the stimulation period be 1-15 milliampere. The stimulation of skeletal muscle tissue may for example be performed using a frequency of 50 Hz and pulses having a duration of 100 ps. The current amplitude may be 1, 2.5, 7.5 or 10 mA. In particular, a desired muscle contraction response has been experimentally observed within a range of 0.5 to 5.0 mA. In the present example, a coiled electrode may be used as a cathode. Another example design is a multi-stranded wire arranged in a helical design. They can be imbricated in the muscular wall of the luminary organ, such as the renal artery 20, and can be stimulated in any desired pattern. The stimulus parameters may for example be biphasic pulses, 10 to 40 Hz, lasting 0.1 to 5 ms, with a current density of 3 to 5 mA/cm2.

Techniques for mitigating fibrin creation caused by the contact between the medical implant and the tissue or flowing blood of a patient, will now be described with reference to figures 18-21. By “medical implant”, or “implantable medical device” as referred to in the following is understood any of the devices discussed above in connection with figures 1-17. Thus, the below described coatings for mitigating fibrin creation may be implemented in a stimulation device 110 as disclosed in figures 4, 5, 6, 8 a signal damping device 120 as disclosed in figure 6, 7, 8, and a sensor as disclosed in figures 12a-d, 13 and 14, other element or part of the systems for treating a patient suffering from hypertension as disclosed herein.

All foreign matter implanted into the human body inevitably causes an inflammatory response. In short, the process starts with the implanted medical device immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface enabling monocytes and macrophages to interact on the surface of the medical implant. The macrophages secrete proteins that modulate fibrosis and in turn developing the fibrosis capsule around the foreign body. In practice, a fibrosis capsule is a dense layer of excess fibrous connective tissue. On a medical device implanted in the abdomen, the fibrotic capsule typically grows to a thickness of about 0,5mm - 2mm, and is substantially inelastic and dense.

The body tends to react to a medical implant, partly because the implant is a foreign object, and partly because the implant interacts mechanically with tissue of the body and/or blood flowing within the body. Implantation of medical devices and or biomaterial in the tissue of a patient may trigger the body’s foreign body reaction (FBR). FBR leads to a formation of foreign body giant cells and the development of a fibrous capsule enveloping the implant. The formation of a dense fibrous capsule that isolates the implant from the host is the common underlying cause of implant failure. Implantation of medical devices and or biomaterial in a blood flow may also cause the formation of fibrous capsules due to the attraction of certain cells within the blood stream.

Implants may, due to the fibrin formation cause blood clotting leading to complications for the patient. Implants in contact with flowing blood and/or placed in the body may also lead to bacterial infection. One common way of counteracting the creation of blood clots is by using blood thinners of different sorts. One commonly used blood thinner is called heparin. However, heparin have certain side-effects that are undesirable.

Fibrin is an insoluble protein that is partly produced in response to bleeding and is the major component of blood clots. Fibrin is formed by fibrinogen, a soluble protein that is produced by the liver and found in blood plasma. When tissue damage results in bleeding, fibrinogen is converted at the wound into fibrin by the action of thrombin, a clotting enzyme. The fibrin then forms, together with platelets, a hemostatic plug or clot over a wound site.

The process of forming fibrin from fibrinogen starts with the attraction of platelets. Platelets have thrombin receptors on their surfaces that bind serum thrombin molecules. These molecules can in turn convert soluble fibrinogen into fibrin. The fibrin then forms long strands of tough and insoluble protein bound to the platelets. The strands of fibrin are then cross-linked so that it hardens and contracts, this is enabled by Factor XIII which is a zymogen found in the blood of humans.

Figures 17a-c describes the reaction that takes place when a blood vessel is damaged. A blood vessel 700 is damaged and wound 710 appears. The blood contains many different cells and particles, for example red blood cells 720 and platelets 730. When the wound 710 appears red blood cells 720 and platelets 730 start to gather at the wound 710. Due to the thrombin receptors on the surface of the platelets 730 a fibrin sheath 740 starts to form which eventually creates a clot that stops the bleeding.

Fibrin may also be created due to the foreign body reaction. When a foreign body is detected in the body the immune system will become attracted to the foreign material and attempt to degrade it. If this degradation fails, an envelope of fibroblasts may be created to form a physical barrier to isolate the body from the foreign body. This may further evolve into a fibrin sheath, in case the foreign body is an implant this may hinder the function of the implant.

Implants can, when implanted in the body, be in contact with flowing blood. This may cause platelet adhesion on the surface of the implants. The platelets may then cause the fibrinogen in the blood to convert into fibrin creating a sheath on and or around the implant. This may prevent the implant from working properly and may also create blood clots that are perilous for the patient. The probe 142 of the sensor 140 in figure 12a is an example of an implant that is in contact with flowing blood when implanted in the body.

Implants not in contact with flowing blood can still malfunction due to fibrin creation. Here the foreign body reaction may be the underlying factor for the malfunction. Further, the implantation of a foreign body into the human body may cause an inflammatory response. The response generally persists until the foreign body has been encapsulated in a relatively dense layer of fibrotic connective tissue, which protects the human body from the foreign body. The process may start with the implant immediately and spontaneously acquiring a layer of host proteins. The blood protein-modified surface enables cells to attach to the surface, enabling monocytes and macrophages to interact on the surface of the implant. The macrophages secrete proteins that modulate fibrosis and in turn develop the fibrosis capsule around the foreign body, i.e., the implant. In practice, a fibrosis capsule may be formed of a dense layer of excess fibrous connective tissue. The inelastic properties of the fibrotic capsule may lead to hardening, tightness, deformity, and distortion of the implant, which in severe cases may result in revision surgery.

Any implant that is implanted into the body may trigger the formation of fibrin sheaths. One example of an implant that may trigger the formation of fibrin sheaths is the probe 142 of the sensor 140 shown in figure 12a, which now will be described as an example in relation to figures 18- 19d. However, the probe 142 may be any implantable medical device either in contact with flowing blood or not in contact with flowing blood.

The sensor 140 may be placed in a blood vessel, such as the renal artery or another blood vessel, to measure a pressure and/or blood flow in the vessel. On the surface of the part of the sensor 140 arranged in the blood flow, indicated by reference numeral 100 in the present figures, blood clots may form. This risk arises from the sensor 100 being in contact with flowing blood and may also be due to the trauma caused to the vein when placing the CVK. Figure 18 shows an implant 100 being a sensor 140 placed inside a blood vessel 700 with a fibrin sheath 740 that has formed on and around part of the sensor 10. The sheath 740 may cause the implant 100 to malfunction and may further create a blood clot that may be harmful for the patient. The formation of a blood clot may have several steps, as depicted in figures 19a-19d. Figure 19a shows a fibrin sheath 740 created on a sensor probe 140 inside a blood vessel 700, such as the renal artery 20 shown in figure 14. In Figure 19b the sheath has further developed into an intraluminal clot 740. In Figure 19c the clot has connected to one side of the vessel creating a mural thrombosis 740. And in Figure 19d the clot has reached a thrombosis 740.

As mentioned, the sensor probe 140 is used as an example. A fibrin sheath 740 may be created on any implantable medical device 100 and may then cover certain necessary part of the device 100 inhibiting the function of the device 10.

Implants or biomaterials that are inserted into the body may also cause infections of different sorts. Bacterial colonization that leads to implant-associated infections are a known issue for many types of implants. For example, the commensal skin bacteria, Staphylococci, and the Staphylococcus aureus tend to colonize foreign bodies such as implants and may cause infections. A problem with the Staphylococci is that it may also produce a biofilm around the implant encapsulating the bacterial niche from the outside environment. This makes it harder for the host defense systems to take care of the bacteria. There are other examples of bacteria and processes that creates bacteria causing infection due to implants.

Figure 20 shows an implantable medical device or implant 100 comprising an implant surface 750 and a coating 760 arranged on the surface 750 . The coating 760 may be configured to have antibacterial and/or antithrombotic characteristics. Depending on the use of the implantable medical device one or both of these effects may be advantageous. The coating 760 may be arranged on the surface 750 so that the coating shields the surface 750 from direct contact with the host body where the implantable medical device 100 is inserted.

The implantable medical device 100 may for example be an element or part of a system for treating hypertension, such as a stimulation device 110 shown in figures 4-6 and 11, a signal damping device 120 shown in figures 6,7 and 11, and a sensor 140 shown in figures 11-14. The coating 760 may then be placed on surfaces of any of these devices, preferably facing the renal artery or elsewhere, or being in contact with the blood flow (such as the sensor 140 when arranged inside the blood vessel).

The coating 760 may comprise at least one layer of a biomaterial. The coating 760 may comprise a material that is antithrombotic. The coating 760 may also comprise a material that is antibacterial. The coating 760 may be attached chemically to the surface 750.

Figure 21 shows an exemplary implantable medical device or implant 100 comprising an at least partially hollow implant body 100. The body 100 may for example form the probe 142 of the sensor 140 shown in figure 12a, or a holding structure such as the cuff shown in figures 5-7 or 13a- b. Since multiple surfaces of the implant 100 may be in contact with flowing blood it may comprise a first coating 760a and a second coating 760b. The coatings 760a and 760b may be similar or have different properties. Depending on how the implant 100 is placed the coatings 760a and 760b may come into contact with different parts or liquids within the body and may therefore comprise either similar materials or materials with different properties. Alternatively, when arranged on the outside of for instance the renal artery, the inner surface may abut the outer wall of the renal artery whereas the outer surface may come in contact with surrounding tissue at the renal artery.

Figure 22 shows an exemplary implantable medical device or implant 100 with a surface 750. The implantable medical device 100 comprises multiple coatings, 760a, 760b, 760c arranged on the surface. The implant 100 may comprise any number of coatings, the particular embodiment of Figure 22 discloses three layers of coating 760a, 760b, 760c. The second coating 760b is arranged on the first coating 760a. The different coating 760a, 760b, 760c may comprise different materials with different features to prevent either fibrin sheath formation or bacteria gathering at the surface 750. As an example, the first coating 760a may comprise a layer of perfluorocarbon chemically attached to the surface. The second coating 760b may comprise a liquid perfluorocarbon layer arranged on the first coating 760a. Perfluorocarbon is used in medicine application in a variety of fields and may be advantageous for using as a coating layer.

The coatings may comprise any type of substance with antithrombotic, antiplatelet or antibacterial features. Such substances include sortase A, perfluorocarbon and more.

The coatings presented in relation to the figures may also be combined with an implantable medical device comprising certain materials that are antibacterial or antithrombotic. For example, some metals have shown to be antibacterial. In case the implant, or at least the surfaces of the implant, are made out of such a metal it may be advantageous in order to reduce bacterial infections. The medical implant or the surface of the implant may be made out of any other suitable metal or material. The surface may for example comprise any of the following metals, or any combination of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.

An implantable medical device can also be coated with a slow releasing anti-fibrotic or antibacterial drug in order to prevent fibrin sheath creation and bacterial inflammation. The drug or medicament may be coated on the surface and be arranged to slowly be released from the implant in order to prevent the creation of fibrin or inflammation. The drug may also be covered in a porous or soluble material that slowly disintegrates in order to allow the drug to be administered into the body and prevent the creation of fibrin. The drug may be any conventional anti-fibrotic or antibacterial drug.

Figure 23a and 23b shows different micropattems on the surface 750 of an implant. In order to improve tissue or blood compatibility, the implant materials physical structure may be altered or controlled. By creating a certain topography on the surface 750 of an implant fibrin creation and inflammatory reactions may be inhibited. Figure 23a is an example of a micropattem that mimics the features of sharkskin. The micropattem may have many different shapes, many different indentation or recess depths into the surface 750 of the implant 100 and may be a complement to other coatings or be used individually. In Figure 23b another example of a micropattem is disclosed.

The micropattem may for example be imprinted or etched into the surface 750 of the implantable medical device 100 prior to insertion into the body. The surface of the implantable medical device 100 may for example comprise a metal. This may for instance be case for the electrode elements of the stimulation device 110 and the signal damping device 120. The surface may for example comprise any of the following metals, or any combination of the following metals: titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead. This may be advantageous in that these metals have proven to be antibacterial which may ensure that the implant functions better when inserted into the host body.

As mentioned above, the system may comprise an energy source for providing the energy required to energize the electrode arrangement and thereby allow the renal artery to be stimulated by the electrical stimulation signal. Figure 24a shows an illustrating example of a system comprising an implantable energy receiver 241 configured to energize the electrode arrangement, as well as an energy source 242 configured to transfer energy wirelessly to the energy receiver 241. The system may be similarly configured as any of the above-mentioned systems for treating a patient suffering from hypertension, such as the system disclosed in any of figures 4-8 or 11. Hence, figure 24a shows a renal artery 20, to which a stimulation device 110 comprising an electrode arrangement 112a, 122a operable to affect a vasomotor tone in the renal artery 20, has been attached. The stimulation device 110 may comprise a plurality of contacting portions 112a, 122a’, or electrode elements, configured to mechanically engage, or be arranged to rest against, tissue of an outer wall of a portion of the renal artery 20 to transmit the electrical stimulation signal to the tissue. The electrode elements 122a, 122a’ may be arranged on an inner surface of a cuff portion 126, similar to the one shown in figure 5, or be attached directly onto the outer wall. In some embodiments, some of the electrode elements 122a, 122a’ may be configured to deliver a damping signal, as outlined above, to hinder the stimulation signal from propagating to part of the body in which it is not desired to deliver the stimulation signal. Further, as illustrated in figure 24a, the system may comprise a control unit which is operably connected to the stimulation device 110 and configured to control an operation of the stimulation device 110 such that the electric stimulation signal (and, optionally, the damping signal) delivered by the electrode arrangement 112a, 122a’ causes the desired vasodilation.

The energy receiver 241, which for example may comprise a coil arrangement configured to receive energy inductively, may be implanted in the body of the patient. In the present example in figure 24a, an energy receiver 241 may be integrated in one or both of the control units 114, 124. However, other arrangements are also possible, in which the energy receiver 241 for example is arranged as a separate element that can be implanted at a different location than the control unit(s) 114, 124. In the latter case, the received energy may be transmitted to the control units(s) 114, 124 or electrode arrangement 112a, 122a’ by a wired connection extending between the energy receiver 241 and the control unit/electrode arrangement.

The energy source 242 may be implantable in the body or arranged outside the body. Similar to the energy receiver 241, the energy source 242 may be configured to be operated on an inductive basis, in which the energy is transferred from the energy source 242 to the energy receiver 241 wirelessly. Hence, the energy source may comprise a coil arrangement enabling the inductive coupling to the energy receiver 241. It will be appreciated that the energy source 242 further may comprise an energy storage, such as a primary or secondary cell, for storing electrical energy for transfer upon request. In case the energy source 242 is implanted in the body, a non- rechargeable battery may require a surgical procedure for replacement, whereas a rechargeable battery may be recharged wirelessly/inductively from a charging source arranged outside the body. Beneficially, the latter allows the energy source 242 to be recharged without requiring any surgical procedures.

Additionally, or alternatively, the system may comprise a control unit which is configured to transmit the control instructions wirelessly to the stimulation device 110. The control unit may comprise an external part 242 configured to be arrange outside the body of the patient, and an internal part 241 configured to be implanted in the patient. The internal part 241 and the external part 242 may be configured to communicate wirelessly with each other, for example by means of radiofrequency signals or inductive signals. It will be appreciated that the internal part 241 as well as the external part 242 shown in figure 24a may form a control unit similar to what has been described above in connection with previous embodiments, and that they in some embodiments may be structurally integrated in the above described energy receiver 241 and energy source 242. The wireless transmission of data from the internal external part 241 to the external parts 242 may, for instance, relate to sensor values indicating functional or status parameters of the implant or the patient. Examples of such parameters may for example include temperature of an implanted energy source, or another part of the implanted system or the body of the patient. Further examples include information indicating a vasodilation of the renal artery, a blood pressure of the patient, or a nervous reaction triggered by the electric stimulation signal provided by the stimulation device 110. The internal and external parts 241, 242 may further be configured to transmit data relating to a status of an implanted energy source of the system, such as charging capacity, charge status, and the like.

As mentioned in connection with for instance figure 24a and figure 11, a controller, or control unit 140, may be provided for controlling the implantable device. The control may require transmission of data, such as sensor values, operational parameters and ditto instructions, to and/or from the implanted devices and functions. In the following, various aspects and examples of such communication will be discussed. Functions and effects of such a controller will now be described with reference to figures 24a - 24f. The features of the controller described with reference to figures 24a - 24f may be implemented and combined with any of the embodiments of implantable devices disclosed herein. The features may for example be implemented in, or combined with, the stimulation devices 110 shown in figures 4-6, 8 and 11, the signal damping devices 120, 160 shown in figures 6-8 and 11, and the sensor 140 shown in figures 13a-b.

A controller, such as the control units shown in the previous figures, may comprise an internal computing unit, also called a processor. The controller may also comprise a communication unit and circuitry for executing communication functions, including verification, authentication and encryption of data, as described in the following.

The controller may comprise a collection of communication related sub-units such as a wired transceiver, a wireless transceiver, energy storage unit, an energy receiver, a computing unit, a memory, or a feedback unit. The sub-units of the controller may cooperate with each other or operate independently with different purposes. The sub-units of the controller may inherit the prefix “internal”. This is to distinguish these sub-units from the sub-units of the external devices as similar sub-units may be present for both the implanted controller and the external devices. The sub-units of the external devices may similarly inherit the prefix “external”.

A wireless transceiver may comprise both a wireless transmitter and a wireless receiver. The wireless transceiver may also comprise a first wireless transceiver and a second wireless transceiver. In this case, the wireless transceiver may be part of a first communication system (using the first wireless transceiver) and a second communication system (using the second wireless transceiver).

In some embodiments, two communication systems may be implemented using a single wireless transceiver in e.g. the implant and a single wireless transceiver in e.g. an external device (i.e. one antenna at the implant and one antenna at the external device), but where for example the network protocol used for data transmission from the external device to the implant is different from the network protocol used for data transmission from the implant to the external device, thus achieving two separate communication systems.

Alternatively, the wireless transceiver may be referred to as either a wireless transmitter or a wireless receiver as not all embodiments of secure wireless communication discussed herein require two-way communication capability of the wireless transceiver. The wireless transceiver may transmit or receive wireless communication via wireless connections. The wireless transceiver may connect to both the implant and to external devices, i.e. devices not implanted in the patient.

The wireless connections may be based on radio frequency identification (RFID), near field charge (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The wireless connections may further be based on mobile telecommunication regimes such as 1G, 2G, 3G, 4G, or 5G. The wireless connections may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), or quadrature amplitude modulation (QAM). The wireless connection may further feature technologies such as time-division multiple access (TDMA), frequency-division multiple access (FDMA), or codedivision multiple access (CDMA). The wireless connection may also be based on infra-red (IR) communication. The wireless connection may feature radio frequencies in the high frequency band (HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF) as well as essentially any other applicable band for electromagnetic wave communication. The wireless connection may also be based on ultrasound communication to name at least one example that does not rely on electromagnetic waves.

A wired transceiver may comprise both a wired transmitter and a wired receiver. The wording wired transceiver aims to distinguish between it and the wireless transceiver. It may generally be considered a conductive transceiver. The wired transceiver may transmit or receive conductive communication via conductive connections. Conductive connections may alternatively be referred to as electrical connections or as wired connections. The wording wired however, does not imply there needs to be a physical wire for conducting the communication. The body tissue of the patient may be considered as the wire. Conductive connection may use the body of the patient as a conductor. Conductive connections may still use ohmic conductors such as metals to at least some extent, and more specifically at the interface between the wired transceiver and the chosen conductor. Communication, conductive or wireless may be understood as digital or analogue. In analogue communication, the message signal is in analogue form i.e., a continuous time signal. In digital communication, usually digital data i.e., discrete time signals containing information is transmitted.

The controller may comprise a sensation generator. A sensation generator is a device or unit that generates a sensation. The sensation generated may be configured to be experienceable by the patient such that the patient may take actions to authenticate a device, connection or communication. The sensation generator may be configured to generate a single sensation or a plurality of sensation components. The sensation or sensation components may comprise a vibration (e.g., a fixed frequency mechanical vibration), a sound (e.g., a superposition of fixed frequency mechanical vibrations), a photonic signal (e.g., a non-visible light pulse such as an infrared pulse), a light signal (e.g., a visual light pulse), an electric signal (e.g., an electrical current pulse) or a heat signal (e.g., a thermal pulse). The sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm.

The sensations generated by the sensation generator may be configured to be experienceable by a sensory function or a sense of the patient from the list of tactile, pressure, pain, heat, cold, taste, smell, sight, and hearing. Sensations may be generated of varying power or force as to adapt to sensory variations in the patient. Power or force may be increased gradually until the patient is able to experience the sensation. Variations in power or force may be controlled via feedback. Sensation strength or force may be configured to stay within safety margins. The sensation generator may be connected to the implant. The sensation generator may be comprised within the implant or be a separate unit.

A motor, e.g. of the active device or unit of the implant, for controlling a physical function in the body of the patient may provide a secondary function as a sensation generator, generating a vibration or sound. Generation of vibrations or sounds of the motor may be achieved by operating the motor at specific frequencies. When functioning as to generate a sensation the motor may operate outside of its normal ranges for frequency controlling a physical function in the body. The power or force of the motor when operating to generate a sensation may also vary from its normal ranges for controlling a physical function in the body.

An external device is a device which is external to the patient in which the implant is implanted in. The external device may be also be enumerated (first, second, third, etc.) to separate different external devices from each other. Two or more external devices may be connected by means of a wired or wireless communication as described above, for example through IP (internet protocol), or a local area network (LAN). The wired or wireless communication may take place using a standard network protocol such as any suitable IP protocol (IPv4, IPv6) or Wireless Local Area Network (IEEE 802. 11), Bluetooth, NFC, RFID etc. The wired or wireless communication may take place using a proprietary network protocol. Any external device may also be in communication with the implant using wired or wireless communication according to the above. Communication with implanted devices may be thus accomplished with a wired connection or with wireless radiofrequency (RF) telemetry. Other methods of wireless communication may be used to communicate with implants, including optical and ultrasound. Alternatively, the concept of intrabody communication may be used for wireless communication, which uses the conductive properties of the body to transmit signals, i.e., conductive (capacitive or galvanic) communication with the implant. Means for conductive communication between an external device and an implant may also be called “electrical connection” between an external device and an implant. The conductive communication may be achieved by placing a conductive member of the external device in contact with the skin of the patient. By doing this, the external device and/or the implant may assure that it is in direct electrical connection with the other device. The concept relies on using the inherent conductive or electrical properties of a human body. Signals may preferably be configured to affect the body or body functions minimally. For conductive communication this may mean using low currents. A current may flow from an external device to an implant or vice versa. Also, for conductive communication, each device may have a transceiver portion for transmitting or receiving the current. These may comprise amplifiers for amplifying at least the received current. The current may contain or carry a signal which may carry e.g., an authentication input, implant operation instructions, or information pertaining to the operation of the implant.

Alternatively, conductive communication may be referred to as electrical or ohmic or resistive communication.

The conductive member may be an integrated part of the external device (e.g. in the surface of a smartwatch that is intended to be in contact with the wrist of the person wearing it), or it may be a separate device which can be connected to the external device using a conductive interrace such as the charging port or the headphone port of a smartphone.

A conductive member may be considered any device or structure set up for data communication with the implant via electric conductive body tissue. The data communication to the implant may be achieved by e.g. current pulses transmitted from the conductive member through the body of the patient to be received by a receiver at the implant. Any suitable coding scheme known in the art may be employed. The conductive member may comprise an energy storage unit such as a battery or receive energy from e.g. a connected external device.

The term conductive interface is representing any suitable interface configured for data exchange between the conductive member and the external device. The conductive member may in an alternative configuration receive and transmit data to the external device through a radio interface, NFC, and the like.

An external device may act as a relay for communication between an implant and a remote device, such as e.g., second, third, or other external devices. Generally, the methods of relaying communication via an external device may be preferable for a large number of reasons. The transmission capabilities of the implant may be reduced, reducing its technical complexity, physical dimensions, and medical effects on the patient in which the implant is implanted. Communication may also be more efficient as direct communication, i.e., without a relaying device, with an implant from a remote device may require higher energy transmissions to account for different mediums and different rates of attenuation for different communication means. Remote communication with lower transmission energy may also increase the security of the communication as the spatial area or volume where the communication may be at all noticeable may be made smaller. Utilizing such a relay system further enables the use of different communication means for communication with the implant and communication with remote devices that are more optimized for their respective mediums.

An external device may be any device having processing power or a processor to perform the methods and functions needed to provide safe operation of the implant and provide the patient or other stakeholders (caregiver, spouse, employer etc.) with information and feedback from the implant. Feedback parameters could include battery status, energy level at the controller, the fluid level of a hydraulic construction device or sensor, number of operations that the stimulation device has performed, blood pressure in the renal artery, a systemic blood pressure of the patient, version number etc. relating to functionality of the implantable device. The external device may for example be a handset such as a smartphone, smartwatch, tablet etc. handled by the patient or other stakeholders. The external device may be a server or personal computer handled by the patient or other stakeholders. The external device may be cloud based or a virtual machine. In the drawings, the external device handled by the patient is often shown as a smart watch, or a device adapted to be worn by the patient at the wrist of the patient. This is merely by way of example and any other type of external device, depending on the context, is equally applicable.

Several external devices may exist such as a second external device, a third external device, or another external device. The above listed external devices may e.g., be available to and controllable by a patient, in which an implant is implanted, a caregiver of the patient, a healthcare professional of the patient, a trusted relative of the patient, an employer or professional superior of the patient, a supplier or producer of the implant or its related features. By controlling the external devices may provide options for e.g. controlling or safeguarding a function of the implant, monitoring the function of the implant, monitoring parameters of the patient, updating or amending software of the implant etc.

An external device under control by a supplier or producer of the implant may be connected to a database comprising data pertaining to control program updates and/or instructions. Such database may be regularly updated to provide new or improved functionality of the implant, or to mitigate for previously undetected flaws of the implant. When an update of a control program of an implant is scheduled, the updated control program may be transmitted from the database in a push mode and optionally routed via one or more further external devices before received by the implanted controller. In another embodiment, the update is received from the database by request from e.g. an external device under control by the patient having the implant implanted in his/her body, a pull mode.

The external device may require authentication to be operated in communication with other external devices or the implant. Passwords, multi-factor authentication, biometric identification (fingerprint, iris scanner, facial recognition, etc.) or any other way of authentication may be employed.

The external device may have a user interface (UI) for receiving input and displaying information/feedback from/to a user. The UI may be a graphical UI (GUI), a voice command interface, speaker, vibrators, lamps, etc.

The communication between external devices, or between an external device and the implant may be encrypted. Any suitable type of encryption may be employed such as symmetric or asymmetric encryption. The encryption may be a single key encryption or a multi-key encryption. In multi-key encryption, several keys are required to decrypt encrypted data. The several keys may be called first key, second key, third key, etc. or first part of a key, second part of the key, third part of the key, etc. The several keys are then combined in any suitable way (depending on the encryption method and use case) to derive a combined key which may be used for decryption. In some cases, deriving a combined key is intended to mean that each key is used one by one to decrypt data, and that the decrypted data is achieved when using the final key.

In other cases, the combination of the several key result in one “master key” which will decrypt the data. In other words, it is a form of secret sharing, where a secret is divided into parts, giving each participant (external device(s), internal device) its own unique part. To reconstruct the original message (decrypt), a minimum number of parts (keys) is required. In a threshold scheme this number is less than the total number of parts (e.g., the key at the implant and the key from one of the two external device are needed to decrypt the data). In other embodiments, all keys are needed to reconstruct the original secret, to achieve the combined key which may decrypt the data.

In should be noted that it is not necessary that the generator of a key for decryption is the unit that in the end sends the key to another unit to be used at that unit. In some cases, the generator of a key is merely a facilitator of encryption/decryption, and the working on behalf of another device/user.

A verification unit may comprise any suitable means for verifying or authenticating the use (i.e., user authentication) of a unit comprising or connected to the verification unit, e.g. the external device. For example, a verification unit may comprise or be connected to an interface (UI, GUI) for receiving authentication input from a user. The verification unit may comprise a communication interface for receiving authentication data from a device (separate from the external device) connected to the device comprising the verification unit. Authentication input/data may comprise a code, a key, biometric data based on any suitable techniques such as fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison, etc. The verification/authentication may be provided using third party applications, installed at or in connection with the verification unit.

The verification unit may be used as one part of a two-part authentication procedure. The other part may, e.g., comprise conductive communication authentication, sensation authentication, or parameter authentication.

The verification unit may comprise a card reader for reading a smart card. A smart card is a secure microcontroller that is typically used for generating, storing and operating on cryptographic keys. Smart card authentication provides users with smart card devices for the purpose of authentication. Users connect their smart card to the verification unit. Software on the verification unit interacts with the keys material and other secrets stored on the smart card to authenticate the user. In order for the smart card to operate, a user may need to unlock it with a user-PIN. Smart cards are considered a very strong form of authentication because cryptographic keys and other secrets stored on the card are very well protected both physically and logically and are therefore hard to steal.

The verification unit may comprise a personal e-ID that is comparable to, for example, passport and driving license. The e-ID system comprises is a security software installed at the verification unit, and a e-ID which is downloaded from a web site of a trusted provided or provided via a smart card from the trusted provider.

The verification unit may comprise software for SMS-based two-factor authentication. Any other two-factor authentication systems may be used. Two-factor authentication requires two things to get authorized: something you know (your password, code, etc.) and something you have (an additional security code from your mobile device (e.g., a SMS, or a e-ID) or a physical token such as a smart card).

Other types of verification/user authentication may be employed. For example, a verification unit which communicate with an external device using visible light instead of wired communication or wireless communication using radio. A light source of the verification unit may transmit (e.g. by flashing in different patterns) secret keys or similar to the external device which uses the received data to verify the user, decrypt data or by any other means perform authentication. Light is easier to block and hide from an eavesdropping adversary than radio waves, which thus provides an advantage in this context. In similar embodiments, electromagnetic radiation is used instead of visible light for transmitting verification data to the external device.

Parameters relating to functionality of the implant may comprise for example a status indicator of the implant such as battery level, version of control program, properties of the implant, status of a motor of the implant, temperature of the implant (such as the battery or control unit), etc. Data comprising operating instructions sent to the implant may comprise a new or updated control program, parameters relating to specific configurations of the implant, etc. Such data may for example comprise instructions how to operate the body engaging portion of the implantable device, such as the electrode arrangement of the stimulation or damping device, instructions to collect patient data, instructions to transmit feedback, etc.

The expressions “confirming the electrical connection between an implant and an external device” or “authenticating a connection between an implant and an external device”, or similar expressions, are intended to encompass methods and processes for ensuring or be reasonably sure that the connection has not been compromised. Due to weaknesses in the wireless communication protocols, it is a simple task for a device to “listen” to the data and grab sensitive information, e.g. personal data regarding the patient sent from the implant, or even to try to compromise (hack) the implant by sending malicious commands or data to the implant. Encryption may not always be enough as a security measure (encryption schemes may be predictable), and other means of confirming or authenticating the external device being connected to the implant may be needed.

The expression “network protocol” is intended to encompass communication protocols used in computer networks, a communication protocol is a system of rules that allow two or more entities of a communications system to transmit information via any kind of variation of a physical quantity. The protocol defines the rules, syntax, semantics and synchronization of communication and possible error recovery methods. Protocols may be implemented by hardware, software, or a combination of both. Communication protocols have to be agreed upon by the parties involved. In this field, the term “standard” and “proprietary” is well defined. A communication protocol may be developed into a protocol standard by getting the approval of a standards organization. To get the approval the paper draft needs to enter and successfully complete the standardization process. When this is done, the network protocol can be referred to a “standard network protocol” or a “standard communication protocol”. Standard protocols are agreed and accepted by whole industry. Standard protocols are not vendor specific. Standard protocols are often, as mentioned above, developed by collaborative effort of experts from different organizations.

Proprietary network protocols, on the other hand, are usually developed by a single company for the devices (or Operating System) which they manufacture. A proprietary network protocol is a communications protocol owned by a single organization or individual. Specifications for proprietary protocols may or may not be published, and implementations are not freely distributed. Consequently, any device may not communicate with another device using a proprietary network protocol, without having the license to use the proprietary network protocol, and knowledge of the specifications for proprietary protocol. Ownership by a single organization thus gives the owner the ability to place restrictions on the use of the protocol and to change the protocol unilaterally. A control program is intended to define any software used for controlling the implant. Such software may comprise an operating system of the implant, of parts of an operating system or an application running on the implant such as software controlling a specific functionality of the implant (e.g. the active unit of the implant, feedback functionality of the implant, a transceiver of the implant, encoding/decoding functionality of the implant, etc.). The control program may thus control the medical function of the implant, for example the pressure applied by the device or the power of the electrical stimulation device. Alternatively, or additionally, the control program may control internal hardware functionality of the implant such as energy usage, transceiver functionality, etc.

The systems and methods disclosed hereinabove may be implemented as software, firmware, hardware or a combination thereof. In a hardware implementation, the division of tasks between functional units referred to in the above description does not necessarily correspond to the division into physical units; to the contrary, one physical component may have multiple functionalities, and one task may be carried out by several physical components in cooperation. Certain components or all components may be implemented as software executed by a digital signal processor or microprocessor or be implemented as hardware or as an application-specific integrated circuit. Such software may be distributed on computer readable media, which may comprise computer storage media (or non-transitory media) and communication media (or transitory media). As is well known to a person skilled in the art, the term computer storage media includes both volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information, and which can be accessed by a computer. Further, it is well known to the skilled person that communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media.

A controller for controlling the implantable device according to any of the embodiments herein and for communicating with devices external to the body of the patient and/or implantable sensors will now be described with reference to figures 24b - 24d. Figure 24b shows a patient when an implantable device 100 for treating hypertension, comprising a controller 300, has been implanted. The implantable device 100 may for example be the stimulation device 110 described in any one of figures 4-6, 8 and 11, the signal damping device 120 described in any of figures 6-8 and 11, or a sensor 140 described with reference to figures 11-14. The implantable device 100 may comprise an active unit 302, which is the part of the implantable device which comprises the one or more operation device, which may be a means providing a hydraulic, pneumatic, or mechanical action for operating a sensor device 140 as shown in figures 13a-b. The active unit may be directly or indirectly connected to the body of the patient for causing the sensor to abut the outside of the blood vessel 20 to generate a signal indicative of a blood pressure in the blood vessel 20. Alternatively, the active unit 302 may be the functionality of the implantable device which generates the electrical stimulation and/or damping signal for inducing vasodilation in the renal artery or reducing spreading of the stimulation signal, as previously discussed. The active unit 302 may in such examples comprise an energy source, such as a battery, or be connected to such an energy source, and may in further examples comprise the control unit generating said signals. The active unit 302 may be connected to the controller 300 via an electrical connection C2. The controller 300 (further described with reference to figure 24c) is configured to communicate with an external device 320 (further described with reference to figure 24d). The controller 300 can communicate wirelessly with the external device 320 through a wireless connection WL1, and/or through an electrical connection Cl.

Referring now to figure 24c, one embodiment of the controller 300 will be described in more detail. The controller 300, which may be similar to any one of the control units 114, 124, 150 described in connection with e.g. figures 4-8, 11 and 14, may comprise an internal computing unit 306 configured to control the function performed by the implantable device 100. The computing unit 306 comprises an internal memory 307 configured to store programs thereon. In the embodiment described in fig. 24c, the internal memory 307 comprises a first control program 310 which can control the function of the implantable device 100. The first control program 310 may be seen as a program with minimum functionality to be run at the implantable device only during updating of the second control program 312. When the implantable device is running with the first control program 310, the implantable device may be seen as running in safe mode, with reduced functionality. For example, the first control program 310 may result in that no sensor data is stored in the implantable device while being run, or that no feedback is transmitted from the implantable device while the first control program 310 is running. By having a low complexity first control program, memory at the implantable device is saved, and the risk of failure of the implantable device during updating of the second control program 312 is reduced.

The second control program 312 is the program controlling the implantable device in normal circumstances, providing the implantable device with full functionality and features.

The memory 307 can further comprise a second, updatable, control program 312. The term updatable is to be interpreted as the program being configured to receive incremental or iterative updates to its code, or be replaced by a new version of the code. Updates may provide new and/or improved functionality to the implant as well as fixing previous deficiencies in the code. The computing unit 306 can receive updates to the second control program 312 via the controller 300. The updates can be received wirelessly WL1 or via the electrical connection Cl . As shown in figure 24c, the internal memory 307 of the controller 300 can possibly store a third program 314. The third program 314 can control the function of the implantable device 100 and the computing unit 306 may be configured to update the second program 312 to the third program 314. The third program 314 can be utilized when rebooting an original state of the second program 312. The third program 314 may thus be seen as providing a factory reset of the controller 300, e.g. restore it back to factory settings. The third program 314 may thus be included in the implant 300 in a secure part of the memory 307 to be used for resetting the software (second control program 312) found in the controller 300 to original manufacturer settings.

The controller 300 may comprise a reset function 316 connected to or part of the internal computing unit 306 or transmitted to said internal computing unit 306. The reset function 316 is configured to make the internal computing unit 306 switch from running the second control program 312 to the first control program 310. The reset function 316 could be configured to make the internal computing unit 306 delete the second control program 312 from the memory 307. The reset function 316 can be operated by palpating or pushing/put pressure on the skin of the patient. This could be performed by having a button on the implant. Alternatively, the reset function 316 can be invoked via a timer or a reset module. Temperature sensors and/ or pressure sensors can be utilized for sensing the palpating. The reset function 316 could also be operated by penetrating the skin of the patient. It is further plausible that the reset function 316 can be operated by magnetic means. This could be performed by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 could be configured such that it only responds to magnetic forces applied for a duration of time exceeding a limit, such as 2 seconds. The time limit could equally plausible be 5 or 10 seconds, or longer. In these cases, the implant could comprise a timer. The reset function 316 may thus include or be connected to a sensor for sensing such magnetic force.

In addition to or as an alternative to the reset function described above, the implant may comprise an internal computing unit 306 (comprising an internal processor) comprising the second control program 312 for controlling a function of the implantable device, and a reset function 318. The reset function 318 may be configured to restart or reset said second control program 312 in response to: i. a timer of the reset function 318 has not been reset, or ii. a malfunction in the first control program 310.

The reset function 318 may comprise a first reset function, such as, for example, comprise a computer operating properly, COP, function connected to the internal computing unit 306. The first reset function may be configured to restart or reset the first or the second control program 312 using a second reset function. The first reset function comprises a timer, and the first or the second control program is configured to periodically reset the timer.

The reset function 318 may further comprise a third reset function connected to the internal computing unit and to the second reset function. The third reset function may in an example be configured to trigger a corrective function for correcting the first 310 or second control program 312, and the second reset function is configured to restart the first 310 or second control program 312 some time after the corrective function has been triggered. The corrective function may be a soft reset or a hard reset.

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

The controller 300 may further comprise an internal wireless transceiver 308. The transceiver 308 communicates wirelessly with the external device 320 through the wireless connection W1. The transceiver may further communicate with an external device 320, 300 via wireless connection WL2 or WL4. The transceiver may both transmit and receive data via either of the connections Cl, WL1, WL2 and WL4. Optionally, the external devices 320 and 300, when present, may communicate with each other, for example via a wireless connection WL3.

The controller 300 can further be electrically connected Cl to the external device 320 and communicate by using the patient’s body as a conductor. The controller 300 may thus comprise a wired transceiver 303 or an internal transceiver 303 for the electrical connection Cl.

The confirmation/authentication of the electrical connection can be performed as described herein in the section for confirmation and/or authentication. In these cases, the implantable device and/or external device(s) 320 comprises the necessary features and functionality (described in the respective sections of this document) for performing such confirmation/authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.

In figures 24b - 24d the patient is a human, but other mammals are equally plausible. It is also plausible that the communication is performed by inductive means. It is also plausible that the communication is direct, without being relayed via any intermediate means or functions.

The controller 300 of the implantable device 100 according to figure 24c further comprises a feedback unit 349. The feedback unit 349 provides feedback related to the switching from the second control program 312 to the first control program 310. The feedback could for example represent the information on when the update of the software, i.e. the second control program 312, has started, and when the update has finished. This feedback can be visually communicated to the patient, via for example a display on the external device 320. This display could be located on a watch, or a phone, or any other external device 320 coupled to the controller 300. Preferably, the feedback unit 349 provides this feedback signal wirelessly WL1 to the external device 320. Potentially, the words “Update started”, or “Update finished”, could be displayed to the patient, or similar terms with the same meaning. Another option could be to display different colors, where green for example could mean that the update has finished, and red or yellow that the update is ongoing. Obviously, any color is equally plausible, and the user could choose these depending on personal preference. Another possibility would be to flash a light on the external device 320. In this case the external device 320 comprises the light emitting device(s) needed. Such light could for example be a LED. Different colors could, again, represent the status of the program update. One way of representing that the update is ongoing and not yet finished could be to flash the light, i.e. turning the light on and off. Once the light stops flashing, the patient would be aware of that the update is finished. The feedback could also be audible, and provided by the implantable device 300 directly, or by the external device 320. In such cases, the implantable device 100 and external device 320 comprises means for providing audio. The feedback could also be tactile, for example in the form of a vibration that the user can sense. In such case, either the implantable device 100 or external device 320 comprises means for providing a tactile sensation, such as a vibration and/or a vibrator.

As seen in figure 24c, the controller 300 can further comprise a first energy storage unit 40A. The first energy storage unit 40A runs the first control program 310. The controller 300 further comprises a second energy storage unit 40B which runs the second control program 312. This may further increase security during update, since the first control program 310 has its own separate energy storage unit 40A. The first power supply 40A can comprise a first energy storage 304a and/or a first energy receiver 305a. The second energy storage unit 40B can comprise a second energy storage 304b and/or a second energy receiver 305b. The energy can be received wirelessly by inductive or conductive means. An external energy storage unit can for example transfer an amount of wireless energy to the energy receiver 305a, 305b inside the patient’s body by utilizing an external coil which induces a voltage in an internal coil (not shown in figures). It is plausible that the first energy receiver 305a receives energy via a RFID pulse. The feedback unit 349 can provide feedback pertaining to the amount of energy received via the RFID pulse. The amount of RFID pulse energy that is being received can be adjusted based on the feedback, such that the pulse frequency is successively raised until a satisfying level is reached.

The controller 300 of the implantable device 100 according to figure 24c further comprises a feedback unit an electrical switch 309. The electrical switch 309 could be mechanically connected to the implantable element configured to exert a force on a body portion of a patient and being configured to be switched as a result of the force exerted on the body portion of a patient exceeding a threshold value. The switch 309 could for example be electrically connected to the operation device, which may be understood as a device powering electrode elements of the stimulation and/or signal damping device, or a controller configured to control the operation thereof, and being configured to be switched as a result of the supplied current exceeding a threshold value. The switch 309 could for example be connected to a hydraulic pump or motor for operating the sensor device 140 shown in figures 13a-b and be configured to be switched if the current exceeds a threshold value. Such a switch could for example be a switch 309 configured to switch if exposed to a temperature exceeding a threshold value, such as a bimetal switch which is switched by the heat created by the flow of current to e.g. the motor. In the alternative, the switch 309 configured to switch if exposed to a temperature exceeding a threshold value could be placed at a different location on the implantable device 100 to switch in case of exceeding temperatures, thereby hindering the implantable device from overheating which may cause tissue damage.

The switch 309 could either be configured to cut the power to the operation device or to generate a control signal to the processor 306 of the implantable controller 300, such that the controller 300 can take appropriate action, such as reducing power or turning off the operation device.

The external device 320 is represented in figure 24d. The external device 320 can be placed anywhere on the patient’s body, preferably on a convenient and comfortable place. The external device 320 could be a wristband, and/or have the shape of a watch. It is also plausible that the external device is a mobile phone or other device not attached directly to the patient. The external device as shown in figure 24d comprises a wired transceiver 323, and an energy storage 324. It also comprises a wireless transceiver 328 and an energy transmitter 325. It further comprises a computing unit 326 and a memory 327. The feedback unit 322 in the external device 320 is configured to provide feedback related to the computing unit 326. The feedback provided by the feedback unit 322 could be visual. The external device 320 could have a display showing such visual feedback to the patient. It is equally plausible that the feedback is audible, and that the external device 320 comprises means for providing audio. The feedback given by the feedback unit 322 could also be tactile, such as vibrating. The feedback could also be provided in the form of a wireless signal WL1, WL2, WL3, WL4.

The second, third or fourth communication methods WL2, WL3, WL4 may be a wireless form of communication. The second, third or fourth communication method WL2, WL3, WL4 may preferably be a form of electromagnetic or radio-based communication. The second, third and fourth communication method WL2, WL3, WL4 may be based on telecommunication methods. The second, third or fourth communication method WL2, WL3, WL4 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G or 5G.

The external device 320 may be adapted to be in electrical connection Cl with the implantable device 100, using the body as a conductor. The electrical connection Cl is in this case used for conductive communication between the external device 320 and the implantable device 100.

In one embodiment, the communication between controller 300 and the external device 320 over either of the communication methods WL2, WL3, WL4, Cl may be encrypted and/or decrypted with public and/or private keys, now described with reference to Figs. 24b - 24d. For example, the controller 300 may comprise a private key and a corresponding public key, and the external device 320 may comprise a private and a corresponding public key.

The controller 320 and the external device 320 may exchange public keys and the communication may thus be performed using public key encryption. The person skilled in the art may utilize any known method for exchanging the keys.

The controller may encrypt data to be sent to the external device 320 using a public key corresponding to the external device 320. The encrypted data may be transmitted over a wired, wireless or electrical communication channel Cl, WL1, WL2, WL3 to the external device. The external device 320 may receive the encrypted data and decode it using the private key comprised in the external device 320, the private key corresponding to the public key with which the data has been encrypted. The external device 320 may transmit encrypted data to the controller 300. The external device 320 may encrypt the data to be sent using a public key corresponding to the private key of the controller 300. The external device 320 may transmit the encrypted data over a wired, wireless or electrical connection Cl, WL1, WL2, WL3, WL4, directly or indirectly, to the controller of the implant. The controller may receive the data and decode it using the private key comprised in the controller 300.

In an alternative to the public key encryption, described with reference to figs. 24b - 24d, the data to be sent between the controller 300 of the implantable device 100 and an external device 320, 330 or between an external device 320, 330 and the controller 300 may be signed. In a method for sending data from the controller 300 to the external device 320, 330, the data to be sent from the controller 300 may be signed using the private key of the controller 300. The data may be transmitted over a communication channel or connection Cl, WL1, WL2, WL3, WL4. The external device 320, 330 may receive the message and verify the authenticity of the data using the public key corresponding to the private key of the controller 300. In this way, the external device 320, 330 may determine that the sender of the data was sent from the controller 300 and not from another device or source.

A method for communication between an external device 320 and the controller 300 of the implantable device 100 using a combined key is now described with reference to figs. 24b - 24d. A first step of the method comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, WL4 or otherwise, a first key from an external device 320, 330. The method further comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, a second key. The second key may be generated by a second external device, separate from the external device 320, 330 or by another external device being a generator of the second key on behalf of the second external device 320, 330. The second key may be received at the implant from anyone of, the external device 320, the second external device 330, and the generator of the second key. The second external device may be controlled by a caretaker, or any other stakeholder. Said another external device may be controlled by a manufacturer of the implant, or medical staff, caretaker, etc. In case the controller 300 is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from another external device (generator). The routing may be performed as described herein under the tenth aspect. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information. The controller 300 a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller 300. The third key could for example be a license number of the implant or a chip number of the implantable device. The combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used for altering, by the computing unit 306 an operation of the implantable device. The altering an operation of the implantable device may comprise controlling or switching an active unit 302 of the implant. In some embodiments, the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the controller 300, and operating the implantable device 100 using operation instructions in the decrypted data.

Methods for encrypted communication between an external device 320 and the controller 300 will now be described. These methods may comprise: receiving, at the external device 320, by a wireless transceiver 328, a first key, the first key being generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 330, the first key being received from anyone of the second external device 330 and the generator of the second key, receiving, at the external device 320 by the wireless transceiver 328, a second key from the controller 300, deriving a combined key, by a computing unit 326 of the external device 320, by combining the first key and the second key with a third key held by the external device 320 (e.g. in memory 307), transmitting encrypted data from the implant to the external device and receiving the encrypted data at the external device by the wireless transceiver 328, and decrypting, by the computing unit 326, the encrypted data, in the external device 320, using the combined key.

As described above, further keys may be necessary to decrypt the data. Consequently, the wireless transceiver 328 is configured for: receiving a fourth key from a third external device, wherein the computing unit 326 is configured for: deriving a combined key by combining the first, second and fourth key with the third key held by the external device, and decrypting the encrypted data using the combined key.

These embodiments further increase the security in the communication. The computing unit 326 may be configured to confirm the communication between the implant and the external device, wherein the confirmation comprises: measuring a parameter of the patient, by the external device 320, receiving a measured parameter of the patient, from the implantable device 100, comparing the parameter measured by the implantable device 100 to the parameter measured by the external device 320, performing confirmation of the connection based on the comparison, and as a result of the confirmation, decrypting the encrypted data, in the external device, using the combined key.

The keys described in this section may in some embodiments be generated based on data sensed by sensors described herein under the twelfth or thirteenth aspect, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.

Further, increased security for communication between an external device(s) and the implantable device is provided.

A method of communication between an external device 320 and an implantable device 100 is now described with reference to Figs. 24b - 24d, when the implantable device 100 is implanted in a patient and the external device 320 is positioned external to the body of the patient. The external device 320 is adapted to be in electrical connection Cl with the controller 300, using the body as a conductor. The electrical connection C 1 is used for conductive communication between the external device 320 and the implantable device 100. The implantable device 100 comprises the controller 300. Both the controller 300 and the external device 320 comprises a wireless transceiver 308, 208 for wireless communication Cl between the controller 300 and the external device 320. The wireless transceiver 308 (included in the controller 300) may in some embodiments comprise sub-transceivers for receiving data from the external device 320 and other external devices, e.g. using different frequency bands, modulation schemes etc.

In a first step of the method, the electrical connection Cl between the controller 300 and the external device 320 is confirmed and thus authenticated. The implant and/or external device(s) may comprise the necessary features and functionality (described in the present disclosure) for performing such authentication. By such an authentication, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.

The implant may comprise a first transceiver 303 configured to be in electrical connection Cl with the external device, using the body as a conductor. The implant may comprise a first external transmitter 203 configured to be in electrical connection C 1 with the implant, using the body as a conductor, and the wireless transmitter 208 configured to transmit wireless communication W 1 to the controller 300. The first transmitter 323 of the external device 320 may be wired or wireless. The first transmitter 323 and the wireless transmitter 208 may be the same or separate transmitters. The first transceiver 303 of the controller 300 may be wired or wireless. The first transceiver 303 and the wireless transceiver 102 may be the same or separate transceivers.

The controller 300 may comprise a computing unit 306 configured to confirm the electrical connection between the external device 320 and the internal transceiver 303 and accept wireless communication WL1 (of the data) from the external device 320 on the basis of the confirmation.

Data is transmitted from the external device 320 to the controller 300 wirelessly, e.g. using the respective wireless transceiver 308, 208 of the controller 300 and the external device 320. Data may alternatively be transmitted through the electrical connection Cl. As a result of the confirmation, the received data may be used for instructing the implantable device 100. For example, a control program 310 running in the controller 300 may be updated, the controller 300 may be operated using operation instructions in the received data. This may be handled by the computing unit 306.

The method may comprise transmitting encrypted data from the external device 320 to the controller 300 wirelessly. To decrypt the encrypted data (for example using the computing unit 306), several methods may be used.

In one embodiment, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller (by the first internal transceiver 303). The key is then used for decrypting the encrypted data.

In some embodiments the key is enough to decrypt the encrypted data. In other embodiments, further keys are necessary to decrypt the data. In one embodiment, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller 300 (by the first internal transceiver 303). A second key is transmitted (by the wireless transceiver 208) from the external device 320 using the wireless communication WL1 and received at the controller 300 by the wireless transceiver 308. The computing unit 306 is then deriving a combined key from the key and second key and uses this for decrypting the encrypted data. In yet other embodiments, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the controller (by the first internal transceiver 303). A third key is transmitted from a second external device 330, separate from the external device 320, to the implant wirelessly WL2. The third key may be received by a second wireless receiver (part of the wireless transceiver 308) of the controller 300 configured for receiving wireless communication WL2 from second external device 330.

The first and third key may be used to derive a combined key by the computing unit 306, which then decrypts the encrypted data. The decrypted data is then used for instructing the implantable device 100 as described above.

The second external device 330 may be controlled by for example a caregiver, to further increase security and validity of data sent and decrypted by the controller 300.

It should be noted that in some embodiments, the external device is further configured to receive WL2 secondary wireless communication from the second external device 330, and transmit data received from the secondary wireless communication WL2 to the implantable device. This routing of data may be achieved using the wireless transceivers 308, 208 (i.e. the wireless connection WL1, or by using a further wireless connection WL4 between the controller 300 and the external device 320. In these cases, the implant and/or external device(s) comprises the necessary features and functionality for performing such routing. Consequently, in some embodiments, the third key is generated by the second external device 330 and transmitted WL2 to the external device 320 which routes the third key to the controller 300 to be used for decryption of the encrypted data. In other words, the step of transmitting a third key from a second external device, separate from the external device, to the implant wirelessly, comprises routing the third key through the external device 320. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.

In yet other embodiments, a key is transmitted using the confirmed conductive communication channel Cl (i.e. the electrical connection) from the external device 320 to the controller 300. The key is received at the implant (by the first internal transceiver 303). A second key is transmitted from the external device 320 to the controller 300 wirelessly WL1, received at the at the controller 300. A third key is transmitted from the second external device, separate from the external device 320, to the controller 300 wirelessly WL4. Encrypted data transmitted from the external device 320 to the controller 300 is then decrypted using a derived combined key from the key, the second key and the third key. The external device may be a wearable external device. The external device 320 may be a handset. The second external device 330 may be a handset. The second external device 330 may be a server. The second external device 330 may be cloud based.

In some embodiments, the electrical connection Cl between the external device 320 and the controller 300 is achieved by placing a conductive member 201, configured to be in connection with the external device 200, in electrical connection with a skin of the patient for conductive communication Cl with the implant. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such conductive communication. The communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 201, conductive connection Cl, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient.

The keys described in this section may in some embodiments be generated based on data sensed by sensors described herein, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.

Increased security for communication between an external device(s) and an implant is provided, now described in the following with reference to figs. 24b - 24d.

In these embodiments, a method for communication between an external device 320 and the implantable controller 300 is provided. The wireless transceiver 308 (included in the controller 300) may in some embodiments comprise sub-transceivers for receiving data from the external device 320 and other external devices 330, e.g. using different frequency bands, modulation schemes etc.

A first step of the method comprises receiving, at the implant, by a wireless transmission WL1 or otherwise, a first key from an external device 320. The method further comprises receiving, at the implant, by a wireless transmission WL1, WL2, WL3, a second key. The second key may be generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 330. The second key may be received at the implant from anyone of, the external device 320, the second external device 330, and a generator of the second key. The second external device 330 may be controlled by a caretaker, or any other stakeholder. Said another external device may be controlled by a manufacturer of the implant, or medical staff, caretaker, etc.

In case the implant is receiving the second key from the external device 320, this means that the second key is routed through the external device from the second external device 330 or from the another external device (generator). In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such routing. Using the external device 320 as a relay, with or without verification from the patient, may provide an extra layer of security as the external device 320 may not need to store or otherwise handle decrypted information. As such, the external device 320 may be lost without losing decrypted information.

The controller 300 comprises a computing unit 306 configured for deriving a combined key by combining the first key and the second key with a third key held by the controller 300, for example in memory 307 of the controller. The combined key may be used for decrypting, by the computing unit 306, encrypted data transmitted by a wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decrypted data may be used for altering, by the computing unit 306 an operation of the implantable device 100. The altering an operation of the implantable device may comprise controlling or switching an active unit 302 of the implant. In some embodiments, the method further comprises at least one of the steps of, based on the decrypted data, updating a control program running in the implant, and operating the implantable device 100 using operation instructions in the decrypted data.

In some embodiments, further keys are necessary to derive a combined key for decrypting the encrypted data received at the controller 100. In these embodiments, the first and second key are received as described above. Further, the method comprises receiving, at the implant, a fourth key from a third external device, the third external device being separate from the external device, deriving a combined key by combining the first, second and fourth key with the third key held by the controller 300, and decrypting the encrypted data, in the controller 300, using the combined key. Optionally, the decrypted data may be used for altering, by the computing unit 306, an operation of the implant as described above. In some embodiments, the fourth key is routed through the external device from the third external device.

In some embodiments, further security measures are needed before using the decrypted data for altering, by the computing unit 306, an operation of the implantable device. For example, an electrical connection Cl between the implantable device and the external device 320, using the body as a conductor, may be used for further verification of validity of the decrypted data. The electrical connection Cl may be achieved by placing a conductive member 201, configured to be in connection with the external device, in electrical connection with a skin of the patient for conductive communication C 1 with the implant. The communication may thus be provided with an extra layer of security in addition to the encryption by being electrically confined to the conducting path e.g. external device 320, conductive member 201, conductive connection Cl, controller 300, meaning the communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient. Accordingly, in some embodiments, the method comprising confirming the electrical connection between the controller 300 and the external device 320, and as a result of the confirmation, altering an operation of the implantable device based on the decrypted data. The confirmation and authentication of the electrical connection may be performed as described herein under the general features section. In these cases, the implantable device and/or external device(s) 320 comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication. By authenticating according to these aspects, security of the authentication may be increased as it may require a malicious third party to know or gain access to either the transient physiological parameter of the patient or detect randomized sensations generated at or within the patient.

In some embodiments, the confirmation of the electrical connection comprises: measuring a parameter of the patient, by e.g. a sensor of the implantable device 100, measuring the parameter of the patient, by the external device 320, comparing the parameter measured by the implantable device to the parameter measured by the external device 320, and authenticating the connection based on the comparison. As mentioned above, as a result of the confirmation, an operation of the implantable device may be altered based on the decrypted data.

Further methods for encrypted communication between an external device 320 and an implantable device 100 are provided. These methods comprise: receiving, at the external device 320 by a wireless transceiver 328, a first key, the first key being generated by a second external device 330, separate from the external device 320 or by another external device being a generator of the second key on behalf of the second external device 320, the first key being received from anyone of the second external device 330 and the generator of the second key, receiving, at the external device 320 by the wireless transceiver 328, a second key from the controller 300, deriving a combined key, by a computing unit 326 of the external device 320, by combining the first key and the second key with a third key held by the external device 320 (e.g. in memory 327), transmitting encrypted data from the implant to the external device and receiving the encrypted data at the external device by the wireless transceiver 328, and decrypting, by the computing unit 326, the encrypted data, in the external device 320, using the combined key.

In some embodiments, the communication between the controller 300 and the external device 320 needs to be confirmed (authenticated) before decrypting the data. In these cases, the implant and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing such authentication.

These embodiments further increase the security in the communication. In these embodiments the computing unit 326 is configured to confirm the communication between the implant and the external device, wherein the confirmation comprises: measuring a parameter of the patient, by the external device 320, receiving a measured parameter of the patient, from the implantable device 100, comparing the parameter measured by the implantable device 320 to the parameter measured by the external device 320, performing confirmation of the connection based on the comparison, and as a result of the confirmation, decrypting the encrypted data, in the external device, using the combined key.

One or more of the first, second and third key may comprise a biometric key.

The keys described in this section may in some embodiments be generated based on data sensed by sensors, e.g. using the sensed data as seed for the generated keys. A seed is an initial value that is fed into a pseudo random number generator to start the process of random number generation. The seed may thus be made hard to predict without access or knowledge of the physiological parameters of the patient which it is based on, providing an extra level of security to the generated keys.

Further, increased security for communication between an external device(s) 320, 330 and an implant is provided, described with reference to Figs. 24b - 24d. The system for communication between an external device 320 and the controller 300 implanted in a patient. The system comprises a conductive member 321 configured to be in connection (electrical/conductive or wireless or otherwise) with the external device, the conductive member 321 being configured to be placed in electrical connection with a skin of the patient for conductive communication Cl with the implantable device 100. By using a conductive member 321 as defined herein, an increased security for communication between the external device and the implant may be achieved. For example, when a sensitive update of a control program of the controller 300 is to be made, or if sensitive data regarding physical parameters of the patient is to be sent to the external device 320 (or otherwise), the conductive member 321 may ensure that the patient is aware of such communication and actively participate in validating that the communication may take place. The conductive member may, by being placed in connection with the skin of the patient, open the conductive communication channel C 1 between the external device and the controller to be used for data transmission.

Electrical or conductive communication, such as this or as described under the other embodiments, may be very hard to detect remotely, or at least relatively so, in relation to wireless communications such as radio transmissions. Direct electrical communication may further safeguard the connection between the implantable device 100 and the external device 320 from electromagnetic jamming i.e. high-power transmissions other a broad range of radio frequencies aimed at drowning other communications within the frequency range. Electrical or conductive communication will be excessively difficult to be intercepted by a third party not in physical contact with, or at least proximal to, the patient, providing an extra level of security to the communication.

In some embodiments, the conductive member comprises a conductive interface for connecting the conductive member to the external device.

In some embodiments, the conductive member 201 is a device which is plugged into the external device 200, and easily visible and identifiable for simplified usage by the patient. In other embodiments, the conductive member 321 is to a higher degree integrated with the external device 320, for example in the form of a case of the external device 320 comprising a capacitive area configured to be in electrical connection with a skin of the patient. In one example, the case is a mobile phone case (smartphone case) for a mobile phone, but the case may in other embodiments be a case for a personal computer, or a body worn camera or any other suitable type of external device as described herein. The case may for example be connected to the phone using a wire from the case and connected to the headphone port or charging port of the mobile phone.

The conductive communication C 1 may be used both for communication between the controller 300 and the external device 320 in any or both directions. Consequently, according to some embodiments, the external device 320 is configured to transmit a conductive communication (conductive data) to the controller 300 via the conductive member 321.

According to some embodiments, the controller 300 is configured to transmit a conductive communication to the external device 320. These embodiments start by placing the conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication Cl with the controller 300. The conductive communication between the external device 320 and the controller 300 may follow an electrically/conductively confined path comprising e.g. the external device 320, conductive member 321, conductive connection Cl, controller 300.

For the embodiments when the external device 320 transmits data to the controller, the communication may comprise transmitting a conductive communication to the controller 300 by the external device 320. The transmited data may comprise instructions for operating the implantable device 100. Consequently, some embodiments comprise operating the implantable device 100 using operation instructions, by an internal computing unit 306 of the controller 300, wherein the conductive communication Cl comprises instructions for operating the implantable device 100. The operation instruction may for example involve adjusting or seting up (e.g. properties or functionality of) the control unit providing the electric stimulation signal of the implantable device 100.

The transmited data may comprise instructions for updating a control program 310 stored in memory 307 of the controller 300. Consequently, some embodiments comprise updating the control program 310 running in the controller 300, by the internal computing unit 306 of the implant, wherein the conductive communication comprises instructions for updating the control program 310.

For the embodiments when the controller 300 transmits data to the external device 320, the communication may comprise transmiting conductive communication C 1 to the external device 320 by the controller 300. The conductive communication may comprise feedback parameters. Feedback parameters could include batery status, energy level at the controller, a fluid level of the hydraulic constriction device or sensor, number of operations that the stimulation device has performed, properties, temperature, version number etc. relating to functionality of the implantable device 100. In other embodiments, the conductive communication Cl comprises data pertaining to least one physiological parameter of the patient, such as blood pressure etc. The physiological parameter(s) may be stored in memory 307 of the controller 300 or sensed in prior (in real time or with delay) to transmiting the conductive communication C 1. Consequently, in some embodiments, the implantable device 100 comprises a sensor 140 for sensing at least one physiological parameter of the patient, wherein the conductive communication comprises said at least one physiological parameter of the patient.

To further increase security of the communication between the controller 300 and the external device 320, different types of authentication, verification and/or encryption may be employed. In some embodiments, the external device 320 comprises a verification unit 340. The verification unit 340 may be any type of unit suitable for verification of a user, i.e. configured to receive authentication input from a user, for authenticating the conductive communication between the implant and the external device. In some embodiments, the verification unit and the external device comprises means for collecting authentication input from the user (which may or may not be the patient). Such means may comprise a fingerprint reader, a retina scanner, a camera, a GUI for inputing a code, a microphone, device configured to draw blood, etc. The authentication input may thus comprise a code or any be based on a biometric technique selected from the list of: a fingerprint, a palm vein structure, image recognition, face recognition, iris recognition, a retinal scan, a hand geometry, and genome comparison. The means for collecting the authentication input may alternatively be part of the conductive member which comprise any of the above examples of functionality, such as a fingerprint reader or other type of biometric reader.

In some embodiments, the security may thus be increased by receiving an authentication input from a user by the verification unit 340 of the external device 320, and authenticating the conductive communication between the controller 300 and the external device using the authentication input. Upon a positive authentication, the conductive communication channel Cl may be employed for comprising transmitting a conductive communication to the controller 300 by external device 320 and/or transmitting a conductive communication to the external device 320 by the controller 300. In other embodiments, a positive authentication is needed prior to operating the implantable device 100 based on received conductive communication, and/or updating a control program running in the controller 300 as described above.

Figs. 24b - 24d further shows an implantable device 100 implanted in a patient and being connected to a sensation generator 381.

The sensation generator 381 may be configured to generate a sensation. The sensation generator 381 may be contained within the implantable device 100 or be a separate unit. The sensation generator 381 may be implanted. The sensation generator 381 may also be located so that it is not implanted as such but still is in connection with a patient so that only the patient may experience sensations generated. The controller 300 is configured for storing authentication data, related to the sensation generated by the sensation generator 381.

The controller 300 is further configured for receiving input authentication data from the external device 320. Authentication data related to the sensation generated may by stored by a memory 307 of the controller 300. The authentication data may include information about the generated sensation such that it may be analyzed, e.g. compared, to input authentication data to authenticate the connection, communication or device. Input authentication data relates to information generated by a patient input to the external device 320. The input authentication data may be the actual patient input or an encoded version of the patient input, encoded by the external device 320. Authentication data and input authentication data may comprise a number of sensations or sensation components.

The authentication data may comprise a timestamp. The input authentication data may comprise a time stamp of the input from the patient. The timestamps may be a time of the event such as the generation of a sensation by the sensation generator 381 or the creation of input authentication data by the patient. The timestamps may be encoded. The timestamps may feature arbitrary time units, i.e. not the actual time. Timestamps may be provided by an internal clock 360 of the controller 300 and an external clock 362 of the external device 320. The clocks 360, 362 may be synchronized with each other. The clocks 360, 362 may be synchronized by using a conductive connection Cl or a wireless connection WL1 for communicating synchronization data from the external device 320, and its respective clock 362, to the controller 300, and its respective clock 360, and vice versa. Synchronization of the clocks 360, 362 may be performed continuously and may not be reliant on secure communication.

Authentication of the connection may comprise calculating a time difference between the time stamp of the sensation and the time stamp of the input from the patient, and upon determining that the time difference is less than a threshold, authenticating the connection. An example of a threshold may be Is. The analysis may also comprise a low threshold as to fdter away input from the patient that is faster than normal human response times. The low threshold may e.g. be 50ms.

Authentication data may comprise a number of times that the sensation is generated by the sensation generator, and wherein the input authentication data comprises an input from the patient relating to a number of times the patient detected the sensation. Authenticating the connection may then comprise: upon determining that the number of times that the authentication data and the input authentication data are equal, authenticating the connection.

A method of authenticating the connection between an implantable device 100 implanted in a patient, and an external device 320 according includes the following steps.

Generating, by a sensation generator 381, a sensation detectable by a sense of the patient. The sensation may comprise a plurality of sensation components. The sensation or sensation components may comprise a vibration (e.g. a fixed frequency mechanical vibration), a sound (e.g. a superposition of fixed frequency mechanical vibrations), a photonic signal (e.g. a non-visible light pulse such as an infra-red pulse), a light signal (e.g. a visual light pulse), an electric signal (e.g. an electrical current pulse) or a heat signal (e.g. a thermal pulse). The sensation generator may be implanted, configured to be worn in contact with the skin of the patient or capable of creating sensation without being in physical contact with the patient, such as a beeping alarm.

Sensations may be configured to be consistently felt by a sense of the patient while not risking harm to or affecting internal biological processes of the patient.

The sensation generator 381, may be contained within the controller 300 or be a separate entity connected to the controller 300. The sensation may be generated by a motor (denoted as M in several embodiments shown herein) of the implantable device 100, wherein the motor being the sensation generator 381. The sensation may be a vibration, or a sound created by running the motor. The sensation generator 381 may be located close to a skin of the patient and thus also the sensory receptors of the skin. Thereby the strength of some signal types may be reduced.

Storing, by the controller 300, authentication data, related to the generated sensation.

Providing, by the patient input to the external device, resulting in input authentication data. Providing the input may e.g. comprise an engaging an electrical switch, using a biometric input sensor or entry into digital interface running on the external device 320 to name just a few examples.

Transmitting the input authentication data from the external device to the controller 300. If the step was performed, the analysis may be performed by the controller 300. Transmitting the authentication data from the implantable device 100 to the external device 320. If the step was performed, the analysis may be performed by the external device 320. The wireless connection WL1 or the conductive connection Cl may be used to transmit the authentication data or the input authentication data.

Authenticating the connection based on an analysis of the input authentication data and the authentication data e.g. by comparing a number of sensations generated and experienced or comparing time stamps of the authentication data and the input authentication data. If step was performed, the analysis may be performed by the implantable device 100.

Communicating further data between the controller 300 and the external device 320 following positive authentication. The wireless connection WL1 or the conductive connection Cl may be used to communicate the further data. The further data may comprise data for updating a control program 310 running in the controller 300 or operation instructions for operating the implantable device 100. The further data may also comprise data sensed by a sensor 140 connected to the controller 300.

If the analysis was performed by the controller 300, the external device 320 may continuously request or receive, information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the external device 320, that the connection is authenticated, transmitting further data from the external device 320 to the controller 300.

If the analysis was performed by the external device 320, the controller 300 may continuously request or receive, information of an authentication status of the connection between the controller 300 and the external device 320, and upon determining, at the controller 300, that the connection is authenticated, transmitting further data from the controller 300 to the external device 320.

A main advantage of authenticating a connection according to this method is that only the patient may be able to experience the sensation. Thus, only the patient may be able to authenticate the connection by providing authentication input corresponding to the sensation generation.

The sensation generator 381, sensation, sensation components, authentication data, input authentication data, and further data may be further described herein. In these cases, the implantable device 100 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document). Further information and definitions can be found in this document in conjunction with the other aspects.

The method may further comprise transmitting further data between the controller 300 and the external device, wherein the further data is used or acted upon, only after authentication of the connection is performed.

The analysis or step of analyzing may be understood as a comparison or a step of comparing. In one method, increased security for communication between an external device(s) and an implanted controller is provided. Figs. 24b - 24d show an implantable device 100 comprising a controller 300 and an external device 320 which may form a system.

The controller 300 comprises a transceiver 308, 303 configured to establish a connection with an external device 320, i.e. with a corresponding transceiver 328, 323. The connection may be an electrical connection Cl using the transceivers 303, 323, or a wireless connection WL1 using the transceivers 308, 328. The controller 300 further comprises a computing unit 306 configured to verify the authenticity of instructions received at the transceiver 308, 303 from the external device 320. In this aspect, the concept of using previously transmitted instructions for verifying a currently transmitted instructions are employed. Consequently, the transmitting node (in this case the external device) need to be aware of previously instructions transmitted to the implant, which reduces the risk of a malicious device instructing the implant without having the authority to do so.

In an embodiment, the computing unit 306 is configured to verify the authenticity of instructions received at the transceiver 308, 303 by extracting a previously transmitted set of instructions from a first combined set of instructions received by the transceiver. The external device 320 may thus comprise an external device comprising a computing unit 326 configured for: combining a first set of instructions with a previously transmitted set of instructions, forming a combined set of instructions, and transmitting the combined set of instructions to the implant. The previously transmitted set of instructions, or a representation thereof, may be stored in memory 327 of the external device 320.

The combined set of instructions may have a data format which facilitates such extraction, for example including metadata identifying data relating to the previously transmitted set of instructions in the combined set of instructions. In some embodiments, the combined set of instructions comprises the first set of instructions and a cryptographic hash of the previously transmitted set of instructions. Consequently, the method comprises combining, at the external device, a first set of instructions with a previously transmitted set of instructions, forming a first combined set of instructions. A cryptographic hash function is a special class of hash function that has certain properties which make it suitable for use in cryptography. It is a mathematical algorithm that maps data of arbitrary size to a bit string of a fixed size (a hash) and is designed to be a oneway function, that is, a function which is infeasible to invert. Examples include MD5, SHA1, SHA 256, etc. Increased security is thus achieved.

The first combined set of instructions is then transmitted to the implanted controller 300, where it is received by e.g. the transceiver 303, 308. The first combined set of instructions may be transmitted to the implant using a proprietary network protocol. The first combined set of instructions may be transmitted to the controller 300 using a standard network protocol. In these cases, the controller 300 and/or external device(s) comprises the necessary features and functionality (described in the respective sections of this document) for performing transmission of data. By using different communication protocols, at the external device 320, for communication with the controller 300 and with a second external device 330, an extra layer of security is added as the communication between controller 300 and the external device 320 may be made less directly accessible to remote third parties.

At the controller 300, the computing unit 306 verifies the authenticity of the received first combined set of instructions, by: extracting the previously transmitted set of instructions from the first combined set of instructions and comparing the extracted previously transmitted set of instructions with previously received instructions stored in the implant.

Upon determining that the extracted previously transmitted set of instructions equals the previously received instructions stored in the controller 300, the authenticity of the received first combined set of instructions may be determined as valid, and consequently, the first set of instructions may be safely run at the controller 300, and the first combined set of instructions may be stored in memory 307 of the controller 300, to be used for verifying a subsequent received set of instructions.

In some embodiments, upon determining by the internal computing unit 306 that the extracted previously transmitted set of instructions differs from the previously received instructions stored in the controller 300, feedback related to an unauthorized attempt to instruct the implantable device lOmay be provided. For example, the transceiver 308, 303 may send out a distress signal to e.g. the external device 320 or to any other connected devices. The controller 300 may otherwise inform the patient that something is wrong by e.g. vibration or audio. The implantable device 100 may be run in safe mode, using a preconfigured control program which is stored in memory 307 of the controller 300 and specifically set up for these situations, e.g. by requiring specific encoding to instruct the implantable device 100, or only allow a predetermined device (e.g. provided by the manufacturer) to instruct the implantable device 100. In some embodiments, when receiving such feedback at the external device 320, the external device 320 retransmits the first combined set of instructions again, since the unauthorized attempt may in reality be an error in transmission (where bits of the combined set of instructions are lost in transmission), and where the attempt to instruct the implantable device 100 is indeed authorized.

The step of comparing the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300 may be done in different ways. For example, the step of comparing the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300 comprises calculating a difference between the extracted previously transmitted set of instructions with previously received instructions stored in the controller 300, and comparing the difference with a threshold value, wherein the extracted previously transmitted set of instructions is determined to equal the previously received instructions stored in the controller 300 in the case of the difference value not exceeding the threshold value. This embodiment may be used when received instructions is stored in clear text, or a representation thereof, in the controller 300, and where the combined set of instructions, transmitted from the external device also includes such a representation of the previously transmitted instructions. This embodiment may be robust against error in transmission where bits of information are lost or otherwise scrambled.

In other embodiments, the combined set of instructions comprises the first set of instructions and a cryptographic hash of the previously transmitted set of instructions, wherein the method further comprises, at the controller 300, calculating a cryptographic hash of the previously received instructions stored in the controller 300 and comparing the calculated cryptographic hash to the cryptographic hash included in the first combined set of instructions. This embodiment provides increased security since the cryptographic hash is difficult to decode or forge.

The above way of verifying the authenticity of received instructions at the controller 300 may be iteratively employed for further sets if instructions.

To further increase security, the transmission of a first set of instructions, to be stored at the controller 300 for verifying subsequent sets of combined instructions, where each set of received combined instructions will comprise data which in some form will represent, or be based on, the first set of instruction, may be performed.

In one example, the external device 320 may be adapted to communicate with the controller 300 using two separate communication methods. A communication range of a first communication method WL1 may be less than a communication range of a second communication method WL2. A method may comprise the steps of: sending a first part of a key from the external device 320 to the controller 300, using the first communication method WL1 and sending a second part of the key from the external device 320 to the controller 300, using the second communication method WL2. The method may further comprise deriving, in the controller 300, a combined key from the first part of the key and the second part of the key and decrypting the encrypted data, in the controller 300, using the combined key. The encrypted data may also be sent from the external device 320 to the controller 300 using the second communication method WL2. The method may then further comprise confirming an electrical connection Cl between the controller 300 and the external device 320 and as a result of the confirmation, decrypting the encrypted data in the controller 300 and using the decrypted data for instructing the controller 300.

The method may also comprise placing a conductive member 321, configured to be in connection with the external device 320, in electrical connection with a skin of the patient for conductive communication with the controller 300. By means of the electrical connection an extra layer of security is added as a potential hacker would have to be in contact with the patient to access or affect the operation of the implantable device 100.

Using a plurality of communication methods, may increase the security of the authentication and the communication with the implantable device 100 as more than one channel for communication may need to be hacked or hijacked by an unauthorized entity to gain access to the implantable device 100 or the communication.

The electrical connection Cl the conductive member 321 and conductive communication may be further described herein in the general definitions section. In these cases, the controller 300 and/or external device 320 comprise the necessary features and functionality (described in the respective sections of this document).

It should also be noted that any one of the first and second communication methods WL1, WL2 may be needed to be confirmed in order to decrypt the encrypted data in the controller 300 and using the decrypted data for instructing the implantable device 100.

The method may further comprise the step of wirelessly receiving, at the controller 300, a third part of the key from the second external device 330. In this case, the combined key may be derived from the first part of the key, the second part of the key and the third part of the key.

The first communication method WL1 may be a wireless form of communication. The first communication method WL1 may preferably be a form of electromagnetic or radio-based communication however, other forms of communication are not excluded. The first communication method WL1 may comprise or be related to the items of the following list: Radio-frequency identification (RFID), Bluetooth, Bluetooth 5, Bluetooth Low Energy (BLE), Near Field Communication (NFC), NFC-V, Infrared (IR) based communication, Ultrasound based communication.

RFID communication may enable the use of a passive receiver circuit such as those in a RFID access/key or payment card. IR based communication may comprise fiber optical communication and IR diodes. IR diodes may alternatively be used directly, without a fiber, such as in television remote control devices. Ultrasound based communication may be based on the non- invasive, ultrasound imaging found in use for medical purposes such as monitoring the development of mammal fetuses.

The first communication method WL1 may use a specific frequency band. The frequency band of the first communication method WL1 may have a center frequency of 13.56 MHz or 27.12 MHz. These bands may be referred to as industrial, scientific and medical (ISM) radio bands. Other ISM bands not mentioned here may also be utilized for the communication methods WL1, WL2. A bandwidth of the 13.56 MHz centered band may be 14 kHz and a bandwidth of the 27.12 MHz centered band may be 326 kHz.

The communication range of the first communication method WL1 may be less than 10 meters, preferably less than 2 meters, more preferably less than 1 meter and most preferably less than 20 centimeters. The communication range of the first communication method WL1 may be limited by adjusting a frequency and/or a phase of the communication. Different frequencies may have different rates of attenuation. By implementing a short communication range of the first communication method, security may be increased since it may be ensured or made probable that the external device is under control of the patient (holding the external device close to the implant) The communication range of the first communication method WL1 should be evaluated by assuming that a patient’s body, tissue, and bones present the propagation medium. Such a propagation medium may present different attenuation rates as compared to a free space of an airfilled atmosphere or a vacuum.

By restricting the communication range, it may be established that the external device communicating with the implanted controller 300 is in fact on, or at least proximal to, the patient. This may add extra security to the communication.

The second communication method WL2 may be a wireless form of communication. The second communication method WL2 may preferably be a form of electromagnetic or radio-based communication. The second communication method WL2 may be based on telecommunication methods. The second communication method WL2 may comprise or be related to the items of the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (2nd generation cellular technology), 3G, 4G, 5G.

The second communication method WL2 may utilize the ISM bands as mentioned in the above for the first communication method WL1.

A communication range of the second communication method WL2 may be longer than the communication range of the first communication method WL1. The communication range of the second communication method WL2 may preferably be longer than 10 meters, more preferably longer than 50 meters, and most preferably longer than 100 meters.

Encrypted data may comprise instructions for updating a control program 310 running in the implantable device 100. Encrypted data may further comprise instructions for operating the implantable device 100.

In one embodiment, the implantable device 100 may transmit data to an external device 320 which may add an additional layer of encryption and transmit the data to a second external device 330, described with reference to figs. 24b - 24d. By having the external device add an additional layer of encryption, less computing resources may be needed in the implanted controller 300, as the controller 300 may transmit unencrypted data or data encrypted using a less secure or less computing resource requiring encryption. In this way, data can still be relatively securely transmitted to a third device. The transmission of data can be performed using any of the method described herein in addition to the method or in the system described below.

Thus, in an embodiment, a system is provided. The system comprises an implantable device 100 according to any of the preceding embodiments disclosed in for instance figures 4-11, comprising a controller 300 configured to transmit data from the body of the patient to an external device 320, and an encryption unit 382 for encrypting the data to be transmitted. The system further comprises an external device 320 configured to receive the data transmitted by the controller 300, encrypt the received data using a first key and transmit the encrypted received data to a third external device 330. The encryption can be performed using any of the keys described above or below. In some embodiments, the external device 320 is configured to decrypt the data received from the controller 300 before encrypting and transmitting the data. Alternatively, the external device 320 may encrypt and transmit the data received from the controller 300 without decrypting it first.

In one example, the encryption unit 382 is configured to encrypt the data to be transmitted using a second key. The first key or the second key may, for example, information specific to the implantable device 100, a secret key associated with the external device 320, an identifier of the implantable device 100 or an identifier of the controller 300. The second key could be a key transmitted by the external device 320 to the controller 300. In some examples, the second key is a combined key comprising a third key received by the controller 300 from the external device 320.

The first key may be a combined key comprising a fourth key, wherein the fourth key is received by the external device 320 from a fourth device. The fourth device may be a verification unit, either comprised in the external device, or external to the external device and connected to it. The verification unit may have a sensor 350 for verification, such as a fingerprint sensor. More details in regard to this will be described below. Alternatively, the verification unit may be a generator, as described above.

The system may be configured to perform a method for transmitting data using a sensed parameter. The method may comprise transmitting a parameter measured by the external device 320 from the external device 320 to the controller 300. In this case, the comparison of the parameter of the patient measured by the external device 320 and the parameter of the patient measured by the controller 300 may be performed by the controller 300. The implantable device 100 may comprise a first sensor 140 for measuring the parameter of the patient at the implantable device 100. The external device 320 may comprise an external sensor 350 for measuring the parameter of the patient at the external device 320.

Authentication of the connection between the controller 300 and the external device 320 may be performed automatically without input, authentication, or verification from a user or patient. This is because the comparison of parameters measured internally and externally, by the internal and external sensors 351, 350 respectively may be enough to authenticate the connection. This may typically be the case when the parameter of the patient is related to an automatically occurring physiological function of the patient such as e.g. a pulse of the patient. Certain types of authentication may however require actions from the patient, e.g. having the patient perform specific movements.

In the embodiments described herein, the controller 300 may comprise or be connected to a sensation generator 381 as described above. In response to an event in the implant, such as a reset, a restart, receipt of new instructions, receipt of a new configuration or update, installation or activation of new instructions or configuration or update, the controller 300 may be configured to cause the sensation generator 381 to generate a sensation detectable by the patient in which the implantable device 100 is implanted. In some examples, the user may after the sensation verify an action, for example via a user interface of an external device 320.

The implantable device 100 may further implement a method for improving the security of the data transmitted from the controller 300. The method, for encrypted communication between a controller 300, when implanted in a patient’s body, and an external device 320, comprises encoding or encrypting, by the controller 300 or a processor 306 comprised in or connected to the controller 300, data relating to the implantable device 100 or the operation thereof; transmitting, by the controller 300, the data; receiving, by a second communication unit comprised the external device 320, the data; encrypting, by the external device 320, the data using an encryption key to obtain encrypted data; and transmitting the encrypted data to a third external device 330. In this way, the external device 320 may add or exchange the encryption, or add an extra layer of encryption, to the data transmitted by the controller 300. When the controller 300 encodes the data to be transmitted it may be configured to not encrypt the data before transmitting, or only using a lightweight encryption, thus not needing as much processing power as if the controller were to fully encrypt the data before the transmission.

The encrypting, by the controller 300, may comprise encrypting the data using a second key. The encryption using the second key may be a more lightweight encryption than the encryption performed by the external device using the second key, i.e. an encryption that does not require as much computing resources as the encryption performed by the external device 320.

The first or the second key may comprise a private key exchanged as described above with reference to encryption and authentication, or the first or the second key may comprise an information specific to the implantable device 100, a secret key associated with the external device, an identifier of the implantable device 100 or an identifier of the controller 300. They may be combined keys as described in this description, and the content of the keys, any combination of keys, and the exchange of a key or keys is described in the encryption and/or authentication section.

According to one embodiment described with reference to fig. 24b-d, the communication unit 102 or internal controller 102 or control unit 102 comprises a wireless transceiver 108 for communicating wirelessly with an external device, a security module 189, and a central unit, also referred to herein as a computing unit 106, which is to be considered as equivalent. The central unit 106 is configured to be in communication with the wireless transceiver 108, the security module 189 and the implantable medical device or active unit 101. The wireless transceiver 108 is configured to receive communication from the external device 200 including at least one instruction to the implantable medical device 100 and transmit the received communication to the central unit or computing unit 106. The central unit or computing unit 106 is configured to send secure communication to the security module 189, derived from the received communication from the external device 200, and the security module 189 is configured to decrypt at least a portion of the secure communication and verify the authenticity of the secure communication. The security module is further configured to transmit a response communication to the central unit or computing unit 106 and the central unit or computing unit is configured to communicate the at least one instruction to the active unit 101. In the embodiment shown in fig. 24b - 24d, the at least one instruction is based on the response communication, or a combination of the response communication and the received communication from the external device 200.

In the embodiment shown in fig. 24b-24d, the security module 189 comprises a set of rules for accepting communication from the central unit or computing unit 106. In the embodiment shown in fig. 24b-24d, the wireless transceiver 108 is configured to be able to be placed in an off- mode, in which no wireless communication can be transmitted or received by the wireless transceiver 108. The set of rules comprises a rule stipulating that communication from the central unit or computing unit 106 to the security module 189 or to the active unit 101 is only accepted when the wireless transceiver 108 is placed in the off-mode.

In the embodiment shown in fig. 24b-24d, the set of rules comprises a rule stipulating that communication from the central unit or computing unit 106 is only accepted when the wireless transceiver 108 has been placed in the off-mode for a specific time period.

In the embodiment shown in fig. 24b-24d, the central unit or computing unit 106 is configured to verify a digital signature of the received communication from the external device 200. The digital signature could be a hash-based digital signature which could be based on a biometric signature from the patient or a medical professional. The set of rules further comprises a rule stipulating that communication from the central unit 106 is only accepted when the digital signature of the received communication has been verified by the central unit 106. The verification could for example comprise the step of comparing the digital signature or a portion of the digital signature with a previously verified digital signature stored in the central unit 106. The central unit 106 may be configured to verify the size of the received communication from the external device and the set of rules could comprise a rule stipulating that communication from the central unit 106 is only accepted when the size of the received communication has been verified by the central unit 106. The central unit could thus have a rule stipulating that communication above or below a specified size range is to be rejected.

In the embodiment shown in fig. 24b-24d, the wireless transceiver is configured to receive a message from the external device 200 being encrypted with at least a first and second layer of encryption. The central unit 106 the decrypts the first layer of decryption and transmit at least a portion of the message comprising the second layer of encryption to the security model 189. The security module 189 then decrypts the second layer of encryption and transmits a response communication to the central unit 106 based on the portion of the message decrypted by the security module 189.

In the embodiment shown in fig. 24b-24d, the central unit 106 is configured to decrypt a portion of the message comprising a digital signature, such that the digital signature can be verified by the central unit 106, also the central unit 106 is configured to decrypt a portion of the message comprising message size information, such that the message size can be verified by the central unit 106.

In the embodiment shown in fig. 24b-24d, the central unit 106 is configured to decrypt a first and second portion of the message, and the first portion comprises a checksum for verifying the authenticity of the second portion.

In the embodiment shown in fig. 24b-24d, the response communication transmitted from the security module 189 comprises a checksum, and the central unit 106 is configured to verify the authenticity of at least a portion of the message decrypted by the central unit 106 using the received checksum, i.e. by adding portions of the message decrypted by the central unit 106 and comparing the sum to the checksum.

In the embodiment shown in fig. 24c-24d, the set of rules further comprise a rule related to the rate of data transfer between the central unit 106 and the security module 189. The rule could stipulate that the communication should be rejected or aborted if the rate of data transfer exceeds a set maximum rate of data transfer, which may make it harder for unauthorized persons to inject malicious code or instructions to the medical implant.

In the embodiment shown in fig. 24b-24d, the security module 189 is configured to decrypt a portion of the message comprising the digital signature being encrypted with the second layer of encryption, such that the digital signature can be verified by the security module 189. The security module 189 then transmits a response communication to the central unit 106 based on the outcome of the verification, which can be used by the central unit 106 for further decryption of the message or for determining if instructions in the message should be communicated to the active unit 101.

In the embodiment shown in fig. 24b-24d, the central unit 106 is only capable of decrypting a portion of the received communication from the external device 200 when the wireless transceiver 108 is placed in the off-mode. In the alternative, or as an additional layer of security, the central unit 106 may be limited such that the central unit 106 is only capable of communicating instructions to the active unit 101 of the implantable medical device 100 when the wireless transceiver 108 is placed in the off-mode. This ensures that no attacks can take place while the central unit 106 is communicating with the active unit 101.

In the embodiment shown in fig. 24b-24d, the implantable controller 102 is configured to receive, using the wireless transceiver 108, a message from the external device 200 comprising a first un-encrypted portion and a second encrypted portion. The implantable controller 102 (e.g. the central unit 106 or the security module 189) then decrypts the encrypted portion, and uses the decrypted portion to verify the authenticity of the un-encrypted portion. As such, computing power and thereby energy can be saved by not encrypting the entire communication, but rather only the portion required to authenticate the rest of the message (such as a checksum and/or a digital signature)

In the embodiment shown in fig. 24b-24d, the central unit 106 is configured to transmit an encrypted portion to the security module 189 and receive a response communication from the security module 189 based on information contained in the encrypted portion being decrypted by the security module. The central unit 106 is then configured to use the response communication to verify the authenticity of the un-encrypted portion. The un-encrypted portion could comprise at least a portion of the at least one instruction to the implantable medical device 106.

In the embodiment shown in fig. 24b-24d, the implantable controller 102 is configured to receive, using the wireless transceiver 108, a message from the external device 200 comprising information related to at least one of: a physiological parameter of the patient and a physical parameter of the implanted medical device 100, and use the received information to verify the authenticity of the message. The physiological parameter of the patient could be a parameter such as a parameter based on one or more of: a temperature, a heart rate and a saturation value.

The physical parameter of the implanted medical device 100 could comprise at least one of a current setting or value of the implanted medical device 100, a prior instruction sent to the implanted medical device 100 or an ID of the implanted medical device 100.

The portion of the message comprising the information related to the physiological parameter of the patient and/or physical or functional parameter of the implanted medical device 100 could be encrypted, and the central unit 106 may be configured to transmit the encrypted portion to the security module 189 and receive a response communication from the security module 189 based on the information having been decrypted by the security module 189.

In the embodiment shown in fig. 24b-24d, the security module 189 is a hardware security module comprising at least one hardware-based key. The security module 189 may have features that provide tamper evidence such as visible signs of tampering or logging and alerting. It may also be so that the security module 189 is “tamper resistant”, which makes the security module 189 inoperable in the event that tampering is detected. For example, the response to tampering could include deleting keys is tampering is detected. The security module 189 could comprise one or more secure cryptoprocessor chip. The hardware-based key(s) in the security module 189 could have a corresponding hardware-based key placeable in the external device 200. The corresponding external hardware-based key could be placed on a key-card connectable to the external device 200.

In alternative embodiments, the security module 189 is a software security module comprising at least one software-based key, or a combination of a hardware and software-based security module and key. The software-based key may correspond to a software-based key in the external device 200. The software-based key may correspond to a software-based key on a keycard connectable to the external device 200.

In the embodiment shown in fig. 24b-24d, the external device 200 is a handheld external device, however, in alternative embodiments, the external device may be a remote external device or a cloud based external device

In the embodiment shown in fig. 24b-24d, the at least one instruction to the implantable medical device 100 comprises an instruction for changing an operational state of the implantable medical device 100.

In the embodiment shown in fig. 24b-24d, the wireless transceiver 108 is configured to communicate wirelessly with the external 200 device using electromagnetic waves at a frequency below 100 kHz, or more specifically below 40 kHz. The wireless transceiver 108 is thus configured to communicate with the external device 200 using “Very Low Frequency” communication (VLF). VLF signals have the ability to penetrate a titanium housing of the implantable medical device 100, such that the electronics of the implantable medical device 100 can be completely encapsulated in a titanium housing.

The wireless transceiver 108 is configured to communicate wirelessly with the external device 200 using a first communication protocol and the central unit 106 is configured to communicate with the security module 189 using a second, different, communication protocol. This adds an additional layer of security as security structures could be built into the electronics and/or software in the central unit 106 enabling the transfer from a first to a second communication protocol. The wireless transceiver 108 may be configured to communicate wirelessly with the external device using a standard network protocol, which could be one of an RFID type protocol, a WLAN type protocol, a Bluetooth (BT) type protocol, a BLE type protocol, an NFC type protocol, a 3G/4G/5G type protocol, and a GSM type protocol. In the alternative, or as a combination, the wireless transceiver 108 could be configured to communicate wirelessly with the external device 200 using a proprietary network protocol. The wireless transceiver 108 could comprises a Ultra- Wide Band (UWB) transceiver and the wireless communication between the implantable controller 102 and the external device 200 could thus be based on UWB. The use of UWB technology enables positioning of the remote control 320” which can be used by the implanted medical device 100 as a way to establish that the external device 200 is at a position which the implanted medical device 100 and/or the patient can acknowledge as being correct, e.g. in the direct proximity to the medical device 100 and/or the patient, such as within reach of the patient and/or within 1 or 2 meters of the implanted medical device 100. In the alternative, a combination of UWB and BT could be used, in which case the UWB communication can be used to authenticate the BT communication, as it is easier to transfer large data sets using BT.

According to one embodiment described with reference to fig. 24b-24d, the communication unit 102 or controller of the implantable medical device 100 comprises a receiving unit 105 or energy receiver 105 comprising a coil 192 (specifically shown in fig. 113B’) configured for receiving transcutaneously transferred energy. The receiving unit further comprises a measurement unit 194 configured to measure a parameter related to the energy received by the coil 192 and a variable impedance 193 electrically connected to the coil 192. The receiving unit 105 further comprises a switch 195a placed between the variable impedance 193 and the coil 192 for switching off the electrical connection between the variable impedance 193 and the coil 192. The communication unit 102 or controller 102 is configured to control the variable impedance 193 for varying the impedance and thereby tune the coil 192 based on the measured parameter. The communication unit 102 or controller 102 is further configured to control the switch 195a for switching off the electrical connection between the variable impedance 193 and the coil 192 in response to the measured parameter exceeding a threshold value. The controller 102 may further be configured to vary the variable impedance in response to the measured parameter exceeding a threshold value. As such, the coil can be tuned or turned off to reduce the amount of received energy if the amount of received energy becomes excessive. The measurement unit 194 is configured to measure a parameter related to the energy received by the coil 192 over a time period and/or measure a parameter related to a change in energy received by the coil 192 by for example measure the derivative of the received energy over time. The variable impedance 193 is in the embodiment shown in fig. 24c’ placed in series with the coil 192. In alternative embodiments it is however conceivable that the variable impedance is placed parallel to the coil 192.

The first switch 195a is placed at a first end portion 192a of the coil 192, and the implantable medical device 100 further comprises a second switch 195b placed at a second end portion of the coil 192, such that the coil 192 can be completely disconnected from other portions of the implantable medical device 100. The receiving unit 105 is configured to receive transcutaneously transferred energy in pulses according to a pulse pattern. The measurement unit 194 is in the embodiment shown in fig. 24c’ configured to measure a parameter related to the pulse pattern. The controller 102 is configured to control the variable impedance in response to the pulse pattern deviating from a predefined pulse pattern. The controller 102 is configured to control the switch 195a for switching off the electrical connection between the variable impedance 193 and the coil 192 in response to the pulse pattern deviating from a predefined pulse pattern. The measurement unit is configured to measure a temperature in the implantable medical device 100 or in the body of the patient, and the controller 102 is configured to control the first and second switch 195a, 195b in response to the measured temperature.

The variable impedance 193 may comprise a resistor and a capacitor and/or a resistor and an inductor and/or an inductor and a capacitor. The variable impedance 193 may comprise a digitally tuned capacitor or a digital potentiometer. The variable impedance 193 may comprise a variable inductor. The first and second switch comprises a semiconductor, such as a MOSFET. The variation of the impedance is configured to lower the active power that is received by the receiving unit. As can be seen in fig. 24c’, the variable impedance 193, the first and second switch 195a, 195b and the measurement unit 194 are connected to the communication unit/controller 102 and the receiving unit 105 is connected to an energy storage unit 10 such that the energy storage unit 10 can store energy received by the receiving unit 105.

In an embodiment, the implantable device 100 comprises at least one sensor for sensing at least one physiological parameter of the patient or a functional parameter of the implantable device 100, as described with reference to figs. 24b - 24d. The sensor 351 may, for example, be a pressure sensor, an electrical sensor, a clock, a temperature sensor, a motion sensor, an optical sensor, a sonic sensor, an ultrasonic sensor. The sensor 351 is configured to periodically sense the parameter and the controller 300 is configured to, in response to the sensed parameter being above a predetermined threshold, wirelessly broadcast information relating to the sensed parameter. The controller 300 may be configured to broadcast the information using a short to mid-range transmitting protocol, such as a Radio Frequency type protocol, a RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, a NFC type protocol, a 3G/4G/5G type protocol, or a GSM type protocol.

The controller of the implant may be connected to the sensor 351 and be configured to anonymize the information before it is transmitted. The transmission of data may also be called broadcasting of data.

In addition to or as an alternative to transmitting the data when the sensed parameter is above a predetermined threshold, the controller 300 may be configured to broadcast the information periodically. The controller 300 may be configured to broadcast the information in response to a second parameter being above a predetermined threshold. The second parameter may, for example, be related to the controller 300 itself, such as a free memory or free storage space parameter, or a battery status parameter. When the implantable device 100 comprises an implantable energy storage unit and an energy storage unit indicator, the energy storage unit indicator is configured to indicate a functional status of the implantable energy storage unit and the indication may be comprised in the transmitted data. The functional status may indicate at least one of charge level and temperature of the implantable energy storage unit.

In some embodiments the external device 320 is configured to receive the broadcasted information, encrypt the received information using an encryption key and transmit the encrypted received information. In this way, the external device 320 may add an additional layer of encryption or exchange the encryption performed by the controller 300.

In an embodiment, the controller 300 is configured to transmit the data using the body of the patient as a conductor Cl, and the external device 320 is configured to receive the data via the body. Alternatively, or in combination, the controller 300 of the implant is configured to transmit the data wirelessly to the external device WL2. Thus, the controller 300 may implement a method for transmitting data from the controller 300 comprising a processor 306, comprising: obtaining sensor measurement data via a sensor 140 connected to or comprised in the controller 300, the sensor measurement relating to at least one physiological parameter of the patient or a functional parameter of the implantable device 100, and transmitting by the controller 300 the sensor measurement data in response to the sensor measurement being above a predetermined threshold, wherein the sensor 140 is configured to periodically sense the parameter. The method may further comprise broadcasting the sensor measurement data, to be received by an external device 320. The transmitting or broadcasting may comprise using at least one of a Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, or a GSM type protocol.

The method may further comprise, at the processor 306, anonymizing, by the processor, the sensor measurement data before it is transmitted, or encrypting the sensor measurement data, using an encryptor 382 comprised in the processing unit 306, before it is transmitted. The transmitting of the data may further comprise to encode the data before the transmitting. The type of encoding may be dependent on the communication channel or the protocol used for the transmission.

The transmitting may be performed periodically, or in response to a signal received by the processor, for example, by an internal part of the implantable device 100 such as a sensor 140, or by an external device 320.

The parameter may, for example, be at least one of a functional parameter of the implantable device 100 (such as a battery parameter, a free memory parameter, a temperature, a pressure, an error count, a status of any of the control programs, or any other functional parameter mentioned in this description) or a parameter relating to the patient (such as a temperature, a blood pressure, or any other parameter mentioned in this description). In one example, the implantable device 10 comprises an implantable energy storage unit 40 and an energy storage unit indicator 304c, and the energy storage unit indicator 304c is configured to indicate a functional status of the implantable energy storage unit 40, and the sensor measurement comprises data related to the energy storage unit indicator.

In one example, the transmitting comprises transmitting the sensor measurement to an internal processor 306 configured to cause a sensation generator 381 to cause a sensation detectable by the patient in which the implant 100 is implanted.

The method may be implemented in a system comprising the implant 100 as shown in for instance figures 4-11 and an external device 320, and further comprise receiving the sensor measurement data at the external device 320, and, at the external device 320, encrypting the sensor measurement data using a key to obtain encrypted data, and transmitting the encrypted data. The transmitting may, for example, be performed wirelessly WL3 or conductively Cl. In the examples or embodiments transmitting data from or to the implantable device 100, the following method may be implanted in order to verify the integrity of the data, described with reference to figs. 24b - 24c. By verifying the integrity of the data, an external device 320 or a processor 306 comprised in the controller 300 may verify that the data has not been corrupted or tampered with during the transmission. In some examples, data integrity for data communicated between a controller 300 and an external device 320 or between an external device 320 and the controller 300 may be performed using a cyclic redundancy check.

Thus, in a first example, a method for evaluating a parameter of a controller 300 implanted in a patient is described. The controller 300 comprises a processor 306 and a sensor 140 for measuring the parameter. The method comprises measuring, using the sensor 140, the functional parameter to obtain measurement data; establishing a connection between the internal controller 300 and an external device 320 configured to receive data from the implant; determining, by the processor 306, a cryptographic hash or a metadata relating to the measurement data and adapted to be used by the external device 320 to verify the integrity of the received data; transmitting the cryptographic hash or metadata; and transmitting, from the controller 300, the measurement data.

The parameter may, for example, be a parameter of the controller 300, such as a temperature, a pressure, a battery status indicator, a time period length, pressure at a constriction device, a pressure at a sphincter, or a physiological parameter of the patient, such as a pulse, a blood pressure, or a temperature. In some examples, multiple parameters may be used.

The method may further comprise evaluating the measurement data relating to the functional parameter. By evaluating it may be meant to determine if the parameter is exceeding or less than a predetermined value, to extract another parameter from the measurement data, compare the another parameter to a predetermined value, or displaying the another parameter to a user. For example, the method may further comprise, at the external device 320, to determining, based on the evaluating, that the implantable device 100 is functioning correctly, or determining based on the evaluating that the implantable device 100 is not functioning correctly.

If it is determined that the implantable device 100 is not functioning correctly, the method may further comprise sending, from the external device 320, a corrective command to the controller 300, receiving the corrective command at the controller 300, and by running the corrective command correcting the functioning of the implantable device 100 according to the corrective command.

The method may further comprise, at the external device 320, receiving the transmitted cryptographic hash or metadata, receiving the measurement data, and verifying the integrity of the measurement data using the cryptographic hash or metadata. The cryptographic hash algorithm be any type of hash algorithm, i.e. an algorithm comprising a one-way function configured to have an input data of any length as input and produce a fixed-length hash value. For example, the cryptographic hash algorithm may be MD5, SHA1, SHA 256, etc. In some examples, the cryptographic hash is a signature obtained by using a private key of the controller 300, and wherein the verifying, by the external device 320, comprises verifying the signature using a public key corresponding to the private key.

When using a cryptographic hash, the method may further comprise calculating a second cryptographic hash for the received measurement data using a same cryptographic hash algorithm as the processor, and determining that the measurement data has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal (i.e. have the same value).

When using a metadata, the verifying the integrity of the data may comprises obtaining a second metadata for the received measurement data relating to the functional parameter, and determining that the data has been correctly received based on that metadata and the second metadata are equal. The metadata may, for example, be a length of the data or a timestamp. In some examples the measurement data is transmitted in a plurality of data packets. In those examples, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets.

A similar method may be utilized for communicating instructions from an external device 320 to a controller 300 implanted in a patient. The method comprises establishing a first connection between the external device 320 and the controller 300, establishing a second connection between a second external device 330 and the controller 300, transmitting, from the external device 320, a first set of instructions to the controller 300 over the first connection, transmitting, from the second external device 330, a first cryptographic hash or metadata corresponding to the first set of instructions to the controller 300, and, at the controller 300, verifying the integrity of the first set of instructions and the first cryptographic hash or metadata, based on the first cryptographic hash or metadata. The external device 320 may be separate from the second external device 330.

The first connections may be established between the controller 300 and a transceiver of the external communication unit 323. In some examples, the communication using the second connection is performed using a different protocol than a protocol used for communication using the first communication channel. In some examples, the first connection is a wireless connection and the second connection is an electrical connection. The second connection may, for example, be an electrical connection using the patient’s body as a conductor (using 321). The protocols and ways of communicating may be any communication protocols described in this description with reference to Cl, and WL1-WL4. The establishing of the first and second connections are performed according to the communication protocol used for each of the first and the second connections.

When using a cryptographic hash, the verifying the integrity of the first set of instructions may comprise calculating a second cryptographic hash for the received first set of instructions using a same cryptographic hash algorithm as the processor 306 and determining that the first set of instructions has been correctly received based on that the cryptographic hash and the second cryptographic hash are equal. The cryptographic hash may, for example, be a signature obtained by using a private key of the implantable device 100, and wherein the verifying comprises verifying the signature using a public key corresponding to the private key. In some examples, the cryptographic hash is a signature obtained by using a private key of the implantable device 100, and wherein the verifying comprises verifying the signature using a public key corresponding to the private key. The private keys and public keys, as well as the exchange or transmittal of keys have been described in this description. Alternatively, other well-known methods can be used for transmitting or exchanging a key or keys between the external device 320 and the controller 300.

When using a metadata, and wherein the verifying the integrity of the data may comprise obtaining a second metadata for the received first set of instructions and determining that the first set of instructions has been correctly received based on that metadata and the second metadata are equal. The metadata may, for example, be any type of data relating to the data to be transmitted, in this example the first set of instructions. For example, the metadata may be a length of the data to be transmitted, a timestamp on which the data was transmitted or retrieved or obtained, a size, a number of packets, or a packet identifier.

In some examples, the controller 300 may transmit data to an external device 320 relating to the data information in order to verify that the received data is correct. The method may thus further comprise, transmitting, by the controller 300, information relating to the received first set of instructions, receiving, by the external device 320, the information, and verifying, by the external device 320, that the information corresponds to the first set of instructions sent by the external device 320. The information may, for example, comprise a length of the first set of instructions.

The method may further comprise, at the controller 300, verifying the authenticity of the first set of instructions by i. calculating a second cryptographic hash for the first set of instructions, ii. comparing the second cryptographic hash with the first cryptographic hash, iii. determining that the first set of instructions are authentic based on that the second cryptographic hash is equal to the first cryptographic hash, and upon verification of the authenticity of the first set of instructions, storing them at the controller 300.

In some examples, the first set of instructions comprises a cryptographic hash corresponding to a previous set of instruction, as described in other parts of this description.

In some examples, the first set of instructions may comprise a measurement relating to the patient of the body for authentication, as described in other parts of this description.

A system and a method for communication of instructions or control signals between an external device 320 and an implant 100 will now be described with reference to Figs. 24b-c.

The system shown in Figs. 24b-c comprises an implantable device 100, a first external device 320, and a second external device 330. The implant comprises a controller 300 and an implantable constriction device 302, such as a sensor. The controller 300 is adapted to receive an instruction from an external device 320 over the communication channel WL1, Cl and run the instruction to control a function of the implant 100, such as a function of the implantable device 100. The communication channel WL1, Cl may be any type of communication channel, such as a wireless connection WL1 or a conductive connection Cl described herein. For example, the wireless connection may comprise at least one of the following protocols: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, a BLE type protocol, a NFC type protocol, a 3G/4G/5G/6G type protocol, a GSM type protocol, and/or Bluetooth 5.

The first external device 320 is adapted to receive, such as through a user interface, or determine an instruction to be transmitted to the implant 100. The determination of the instruction may, for example, be based on received data from the implantable device 100, such as measurement data or data relating to a state of the implant, such as a battery status or a free memory status. The first external device 320 may be any type of device capable of transmitting information to the implant and capable of determining or receiving an instruction to be transmitted to the implantable device 100. In a preferred embodiment, the first external device 320 is a handheld device, such as a smartphone, smartwatch, tablet etc. handled by the patient, having a user interface for receiving an instruction from a user, such as the patient or a caregiver.

The first external device 320 is further adapted to transmit the instruction to a second external device 330 via communication channel WL3. The second external device 320 is adapted to receive the instruction, encrypt the instruction using an encryption key, and then transmit the encrypted instruction to the implantable device 100. The implantable device 100 is configured to receive the instruction at the controller 300. The controller 300 thus comprises a wired transceiver or a wireless transceiver for receiving the instruction. The implantable device 100 is configured to decrypt the received instruction. The decryption may be performed using a decryption key corresponding to the encryption key. The encryption key, the decryption key and methods for encryption/decryption and exchange of keys may be performed as described in the “general definition of features” or as described with reference to Figs. 24b-c. Further, there are many known methods for encrypting data which the skilled person would understand to be usable in this example.

The second external device 330 may be any computing device capable of receiving, encrypting and transmitting data as described above. For example, the second external device 320 may be a network device, such as a network server, or it may be an encryption device communicatively coupled to the first external device.

The instruction may be a single instruction for running a specific function or method in the implantable device 100, a value for a parameter of the implantable device 100, or a set of sub-steps to be performed by the controller 300 comprised in the implant.

In this way, the instruction for controlling a function of the implantable device 100 may be received at the first external device 320 and transmitted to the implant 100 via the second external device 330. By having a second external device 330 encrypting the instruction before transmitting it to the implantable device 100, the instruction may be verified by the second external device 330 and the first external device 320 may function so as to relay the instruction. In some alternatives, the second external device 330 may transmit the instruction directly to the implantable device 100. This may provide an increased security as the instruction sent to the implantable device 100 may be verified by the second external device 330, which, for example, may be a proprietary device managed by the medical professional responsible for the implantable device 100. Further, by having the second medical device 330 verifying and encrypting the instruction, the responsibility authenticity and/or correctness of the instruction may he with the second external device 330, which may be beneficial for regulatory purposes, as the first external device 320 may not be considered as the instructor of the implantable device 100.

Further, the second external device 330 may verify that the instruction is correct before encrypting or signing and transmitting it to the implantable device 100. The second external device 330 may, for example, verify that the instruction is correct by comparing the instruction with a predetermined set of instructions, and if the instruction is comprised in the predetermined set of instructions determine that the instruction is correct. If the instruction comprises a plurality of substeps, the second external device 330 may determine that the instruction is correct if all the substeps are comprised in the predetermined set of instructions. If the instruction comprises a value for a parameter of the implantable device 100, the second external device 330 may verify that the value is within a predetermined range for the parameter. The second external device 320 may thus comprise a predetermined set of instructions, or a predetermined interval or threshold value for a value of a parameter, stored at an internal or external memory.

The second external device 330 may be configured to reject the instruction, i.e. to not encrypt and transmit the instruction to the implantable device 100, if the verification of the instruction would fail. For example, the second external device 330 determines that the instruction or any sub-step of the instruction is not comprised in the predetermined set of instructions, or if a value for a parameter is not within a predetermined interval, the second external device 330 may determine that the verification has failed.

In some embodiments, the implantable device 100 may be configured to verify the instruction. The verification of the instruction may be performed in the same way as described with reference to Figs. 24b-c. If the verification is performed by comparing the instruction or any substeps of the instruction with a predetermined set of instructions, the controller 300 may comprise a predetermined set of instructions. The predetermined set of instructions may, for example, be stored in an internal memory of the controller 300. Similarly, the controller 300 may store predetermined reference intervals for any parameter that can be set, and the controller 300 may be configured to compare a received value for a parameter to such a predetermined reference interval. If the verification of the instruction would fail, the controller 300 may be configured to reject the instruction, i.e. not run the instruction. In an alternative to encrypting and decrypting the instruction, the instruction may be signed by the second external device 330 using a cryptographic hash, and the controller 300 may be configured to verify that the signature is correct before running the instruction.

A corresponding method for transmitting an instruction will now be described with reference to Figs. 24b-c. The instruction may relate to a function of the implantable device, such as an instruction to run a function or method of the implantable device, or to set a value of a parameter of the implantable device. The method comprises: transmitting an instruction for the implantable device from the first external device 300 to a second external device 320, the instruction relating to a function of the implantable device 100, encrypting, at the second external device 330 using a first encryption key, the instruction into an encrypted instruction, and transmitting the encrypted instruction from the second external device 330 to the implantable device 100, decrypting, at the implantable device, the instructions using a second encryption key corresponding to the first encryption key. The steps performed by or at the implantable device may be executed by the controller 300.

The instruction may be any type of instruction for controlling a function of the implantable device. For example, the instruction may be an instruction to run a function or method of the implantable device 100 or controller 300, an instruction comprising a plurality of sub-steps to be run at the controller 300, or a value for a parameter at the controller 300. The first external device 320 may, for example, receive the instruction from a user via a user interface displayed at or connected to the first external device 320. In another example, the first external device 320 may determine the instruction in response to data received from the implantable device 100, such as measurement data, or from another external device. Thus, in some examples, the method may further comprise receiving, at the first external device 320, an instruction to be transmitted to the implantable device 100. The method may further comprise displaying a user interface for receiving the instruction. In another example, the method comprises determining, at the first external device 320, an instruction to be transmitted to the implantable device 100.

In some embodiments, the transmitting of the encrypted instruction from the second external device 330 to the implantable device 100 comprises transmitting the encrypted instruction from the second external device 330 to the first external device 320, and transmitting the encrypted instruction from the first external device 320 to the controller 300 of the implantable device 100. In other words, the first external device 320 may relay the encrypted instruction from the second external device 330 to the controller 300, preferably without decrypting the instruction before transmitting it.

The method may further comprise to, at the controller 300, running the instruction or performing the instruction. The running of the instruction may be performed by an internal computing unit or a processor 306 comprised in the controller 300, and may, for example, cause the internal computing unit or processor 306 to instruct the implantable constriction device 302 to perform an action.

The method may further comprise verifying, at the second external device 330, that the instructions are correct. The verifying may be performed as described above with reference to the corresponding system.

The method may further comprise verifying, at the controller 300, that the instructions are correct. The verifying may be performed as described above with reference to the corresponding system.

The method may further comprise authenticating the connection between the first external device 320 and the controller 300 over which the encrypted instruction is to be transmitted. The authentication may be performed as described herein.

As described above, a control program of the controller 300 may be updatable, configurable or replaceable. A system and a method for updating or configuring a control program of the controller 300 is now described with reference to figs. 24b - 24d. The controller may comprise an internal computing unit 306 configured to control a function of the implantable device 100, the internal computing unit 306 comprises an internal memory 307 configured to store: i. a first control program 310 for controlling the internal computing unit, and ii. a second, configurable or updatable, with predefined program steps, control program 312 for controlling said function of the implantable device 100, and iii. a set of predefined program steps for updating the second control program 312. The controller 300 is configured to communicate with an external device 320. The internal computing unit 306 is configured to receive an update to the second control program 312 via the controller 300, and a verification function of, connected to, or transmitted to the controller 300. The verification function is configured to verify that the received update to the second control program 312 comprises program steps comprised in the set of predefined program steps. In this way, the updating or programming of the second control program may be performed using predefined program steps, which may decrease the risk that the new or updated control program is incorrect or comprises malicious software, such as a virus, spyware or a malware.

The predefined program steps may comprise setting a variable related to a pressure, a time, a minimum or maximum temperature, a current, a voltage, an intensity, a frequency, an amplitude of electrical stimulation, a feedback mode (sensorics or other), a post-operative mode or a normal mode, a catheter mode, a fibrotic tissue mode (for example semi -open), an time open after urination, a time open after urination before bed-time, a blood pressure reducing mode.

The verification function may be configured to reject the update in response to the update comprising program steps not comprised in the set of predefined program steps and/or be configured to allow the update in response to the update only comprising program steps comprised in the set of predefined program steps. The internal computing unit 306 may be configured to install the update in response to a positive verification, for example by a user using an external device, by a button or similarly pressed by a user, or by another external signal.

The authentication or verification of communications between the implant and an external device has been described above.

When updating a control program of the controller 300, it may be beneficial to transmit a confirmation to a user or to an external device or system. Such a method is now described with reference to figs. 24b - 24c.

The method for updating a control program of a controller 300 comprised in the implantable device 100 according to any of the embodiments herein. The controller 300 is adapted for communication with a first external device 320 and a second external device 330, which may comprise receiving, by the internal computing unit, an update or configuration to the control program from the first external device, wherein the update is received using a first communication channel; installing, by the internal computing unit 306, the update; and transmitting, by the internal computing unit, logging data relating to the receipt of the update or configuration and/or logging data relating to an installation of the update to the second external device 330 using the second communication channel; wherein the first and the second communication channels are different communication channels. By using a first and a second communication channels, in comparison to only using one, the security of the updating may be improved as any attempts to update the control program will be logged via the second communication channel, and thus, increasing the chances of finding incorrect or malicious update attempts.

The update or configuration comprises a set of instructions for the control program, and may, for examples comprise a set of predefined program steps as described above. The configuration or update may comprise a value for a predetermined parameter.

In some examples, the method further comprises confirming, by a user or by an external control unit, that the update or configuration is correct based on the received logging data.

The logging data may be related to the receipt of the update or configuration, and the controller 300 is configured to install the update or configuration in response to receipt of a confirmation that the logging data relates to a correct set of instructions. In this way, the controller 300 may receive data, transmit a logging entry relating to the receipt, and then install the data in response to a positive verification that the data should be installed.

In another example, or in combination with the one described above, the logging data is related to the installation or the update or configuration. In this example the logging data may be for information purposes only and not affect the installation, or the method may further comprise activating the installation in response to the confirmation that the update or configuration is correct.

If the update or configuration is transmitted to the controller 300 in one or more steps, the verification as described above may be performed for each of the steps. The method may further comprise, after transmitting the logging data to the second external device, verifying the update via a confirmation from the second external device 330 via the second communication channel.

With reference to Fig. 24b - 24d there may further be provided an implantable controller 300. The controller 300 is connected to a sensor 351 wherein the sensor 351 is at least one microphone sensor 351 configured to record acoustic signals. For instance, the controller 300 may be configured to register a sound related to at least one of a bodily function of the patient and a function of the implantable device 100. The controller 300 comprises a computing unit 306 configured to derive at least one of a pulse of the patient from the registered sound related to a bodily function, such as information related to the patient urinating, from the registered sound related to a bodily function. In the alternative, the controller 300 could be configured to derive information related to a functional status of the implantable device 100 from the registered sound, such as RPM of the motor. To this end the computing unit 306 may be configured to perform signal processing on the registered sound (e.g. on a digital or analog signal representing the registered sound) so as to derive any of the above mentioned information related to a bodily function of the patient or a function of the implantable device 100. The signal processing may comprise filtering the registered sound signals of the microphone sensor 351.

The implantable controller is placed in an implantable housing for sealing against fluid, and the microphone sensor 351 is placed inside of the housing. Accordingly, the controller and the microphone sensor 351 do not come into contact with bodily fluids when implanted which ensures proper operation of the controller and the microphone sensor 351.

In some implementations, the computing unit 306 is configured to derive information related to the functional status of an active unit 302 of the implantable device 100, from the registered sound related to a function of the implantable device 100. Accordingly, the computing unit 306 may be configured to derive information related to the functional status of at least one of: a motor, a pump and a transmission of the active unit 302 of the implantable device 100, from the registered sound related to a function of the implantable device 100.

The controller may comprise a transceiver 303, 308 configured to transmit a parameter derived from the sound registered by the at least one microphone sensor 351 using the transceiver 303, 308. For example, the transceiver 303, 308 is a transceiver configured to transmit the parameter conductively 303 to an external device 320 or wirelessly 308 to an external device 320.

A method of authenticating the implantable device 100, the external device 320 or a communication signal or data stream between the external device 320 and the implantable device 100 is also described with reference to figs. 24b - 24d. The method comprises the steps of registering a sound related to at least one of a bodily function and a function of the implantable device 100, using the at least one microphone sensor 351, connected to the controller 300. The method could in a first authentication embodiment comprise transmitting a signal derived from the registered sound, using the transceiver 303, 308, receiving the signal in the external device 320, using the receiver 323, 328 and comparing, in the external device 320, a parameter derived from the received signal with a reference parameter, using the computing unit 306. The method could in a second authentication embodiment comprise receiving a signal in the controller 300, from the external device 320, using the transceiver 323, 328 and deriving a reference parameter from the received signal, using the computing unit 306 of the controller 300, and comparing, in the controller 300, a parameter derived from the received signal with the derived reference parameter, using the computing unit 306 of the controller 300. The methods further comprise the steps of the implantable controller 300 authenticating the external device 320, or the external device 320 authenticating the implantable controller 300, on the basis of the comparison. The registered sound could for example be related to the pulse of the patient or to the patient urinating.

Embodiments relating to an implantable device 100 having a controller 300 having a processor 306 with a sleep mode and an active mode will now be described with reference to Fig. 24e. The implant, the internal communication unit and the external device(s) may have the features described above with reference to figs. 24b - 24d.

In an embodiment in which the controller 300 comprises a processor 306 having a sleep mode and an active mode, the controller 300 comprises or is connected to a sensor 140 and a processing unit 306 having a sleep mode and an active mode. The sensor 140 is configured to periodically measure a physical parameter of the patient, and the controller 300 is further configured to, in response to a sensor measurement preceding a predetermined value, setting the processing unit 306 in an active mode. That is, the controller 300 may “wake up” or be set in an active mode in response to a measurement from, for example, the body. A physical parameter of the patient could for example be a pressure in a blood vessel, such as the renal artery, or a vascular (flow) resistance in a blood vessel, local or systemic temperature, saturation/oxygenation, systemic blood pressure or a parameter related to an ischemia marker such as lactate.

By sleeping mode it is meant a mode with less battery consumption and/or processing power used in the processing unit 306, and by “active mode” it may be meant that the processing unit 306 is not restricted in its processing.

The sensor 140 may, for example, be a pressure sensor. The pressure sensor may be adapted to measure a pressure in an organ of a patient, such as the renal artery, or a vasodilation or a vasoconstriction of said artery. The pressure sensor may further be configured to measure a pressure in a reservoir of the implant or a constriction device of the active unit 302. The sensor 140 may be an analog sensor or a digital sensor, i.e. a sensor 140 implemented in part in software. In some examples, the sensor is adapted to measure one or more of a battery or energy storage status of the implantable device 100 and a temperature of the implantable device 100. In this way, the sensor 140 may periodically sense a pressure of the implantable device 100 or of the patient, and set the processing unit 306 in an active mode if the measured pressure is above a predetermined value. Thus, less power, i.e. less of for example a batery or energy storage comprised in the implant, may be used, thereby prolonging the lifetime of the implantable device 100 or increasing the time between charging occasions of the implantable device 100.

In some examples, the processor 306, when in set in the active mode, may cause a sensation generator 381 connected to the implant, comprised in the implantable device 100 or comprised in an external device 320, 330, to generate a sensation detectable by a sense of the patient. For example, the processor may cause the sensation generator to generate a sensation in response to a measure batery status, for example that the batery is above or below a predetermined level, that a measured pressure is above or below a predetermined level, or that another measured parameter has an abnormal value, i.e. less than or exceeding a predetermined interval or level. The sensation generator has been described in further detail earlier in this description.

The processing unit 306 may be configured to perform a corrective action in response to a measurement being below or above a predetermined level. Such a corrective action may, for example, be increasing or decreasing a pressure, increasing or decreasing electrical stimulation, increasing or decreasing power, adjusting a signal damping function, and the like.

The controller 300 may comprise a signal transmiter 320 connected to the processing unit, and wherein the processing unit is configured to transmit data relating to the measurement via the transceiver 308 of the controller 300 or an additional internal signal transmiter 392. The transmited data may be received by an external device 320.

The external device may have an external communication unit 390. The external device 320 may comprise a signal provider 380 for providing a wake signal to the controller 300. In some examples, the signal provider comprises a coil or magnet 371 for providing a magnetic wake signal.

The controller 300 may implement a corresponding method for controlling an implantable device 100 when implanted in a patient. The method comprises measuring, with a sensor of the controller 300 connected to or comprised in the controller 300, a physiological parameter of the patient or a parameter of the implantable device 100, and, in response to a sensor measurement having an abnormal value, seting, by the controller 300, a processor 306 of the controller 300 from a sleep mode to an active mode. The measuring may be carried out periodically. By “abnormal value” it may be meant a measured value exceeding or being less than a predetermined value, or a measured value being outside a predetermined interval. The method may further comprise generating, with a sensation generator 381 as described above, a sensation detectable by the patient. In some examples, the generating comprises requesting, by the processor, the sensation generator 381 to generate the sensation. The method may further comprise to perform a medical intervention in response to a sensor measurement having an abnormal value, preferably after the processing unit has been set in the active mode.

A system comprising an implantable device 100 having a controller 300 having a sleep mode and an active mode will now be described with reference to Fig. 24e. In one embodiment, the controller 300 comprises a sensor 140 adapted to detect a magnetic field and a processing unit 306 having a sleep mode and an active mode, now described with reference to figs. 24b - 24d. The external control unit 320 comprises a signal provider 380 adapted to provide a magnetic field detectable by the internal sensor 140. The controller 300 is further configured to, in response to a detected magnetic field exceeding a predetermined value, setting the processing unit 306 in an active mode. In this way, the external device 320 may cause a sleeping controller 300 or processor 306 to “wake up”.

The sensor 140 may, for example, be a hall effect sensor, a fluxgate sensor, an ultrasensitive magnetic field sensor, a magneto-resistive sensor, an AMR or GMR sensor, or the sensor may comprise a third coil having an iron core.

The magnetic field provider 380 may have an off state, wherein it does not provide any magnetic field, and an on state, wherein it provides a magnetic field. For example, the magnetic field provider 380 may comprise a magnet 371, a coil 371, a coil having a core 371, or a permanent magnet 371. In some embodiments, the magnetic field provider 380 may comprise a shielding means for preventing a magnet 371 or permanent magnet 371 from providing a magnetic field in the off state. In order to provide a substantially even magnetic field, the magnetic field provider may comprise a first and a second coil arranged perpendicular to each other.

After the processing unit 306 has been set in an active mode, i.e. when the processing unit 306 has been woken, the implant may determine a frequency for further communication between the controller 300 and the external device 320. The controller 300 may thus comprise a frequency detector 391 for detecting a frequency for communication between the controller 300 and the second communication unit 390. The frequency detector 391 is, for example, an antenna. The external device 320 may comprise a frequency indicator 372, for transmitting a signal indicative of a frequency. The frequency indicator 372, may, for example, be a magnetic field provider capable of transmitting a magnetic field with a specific frequency. In some examples the frequency indicator is comprised in or the same as the magnetic field provider 371. In this way, the frequency signal is detected using means separate from the sensor, and can, for example, be detected using a pin on a chip.

Alternatively, the controller 300 and the external device 320 may communicate using a predetermined frequency or a frequency detected by means defined by a predetermined method according to a predetermined protocol to be used for the communication between the controller 300 and the external device 320. In some embodiments, the sensor 140 may be used for the communication. The communication may in these embodiments be performed with such that a frequency of the magnetic field generated by the coil is 9-315 kHz, or the magnetic field generated by the coil is less than or equal to 125kHz, preferably less than 58kHz. The frequency may be less than 50Hz, preferably less than 20Hz, more preferably less than 10Hz, in order to be transmittable through a titan box.

In some embodiments, the controller 300 comprises a receiver unit 392, and the internal control unit and the external control unit are configured to transmit and/or receive data via the receiver unit 392 via magnetic induction. The receiver unit 392 may comprise a high-sensitivity magnetic field detector, or the receiver unit may comprise a fourth coil for receiving the magnetic induction.

The system may implement a method for controlling a medical implant implanted in a patient. The method comprises monitoring for signals by a sensor 140 comprised in the controller 300 communicatively coupled to the active unit 302, providing, from a signal provider 380 comprised in an external device 320, a wake signal, the external device 320 being adapted to be arranged outside of the patient’s body, and setting, by the controller 300 and in response to a detected wake signal WS, a mode of a processing unit 306 comprised in the internal control unit from a sleep mode to an active mode.

The method may also comprise detecting, using a frequency detector 391, a frequency for data communication between the controller 300 and a second communication unit 390 being associated with the external device 320. The frequency detector 391 is communicatively coupled to the controller 300 or the external device 320. The detection may be performed using a detection sequence for detecting the frequency. This detection sequence may, for example, be a detection sequence defined in the protocol to be used for communication between the controller 300 and the second communication unit 390. Potential protocols that may be used for communication between the controller 300 and the external device 320 has been described earlier in this description. Thus, the method may comprise determining, using the frequency detector 391, the frequency for data communication, and initiating data communication between the controller 300 and the second communication unit 390. The data communication can, for example, comprise one or more control instructions for controlling the implantable device 100 transmitted from the external device 320, or, for example, comprise data related to the operation of the implantable device 100 and be transmitted from the controller 300.

In some examples, the medical implant may comprise or be connected to a power supply for powering the implantable device 100. This will now be described with reference to fig. 24f. The medical implant, the internal control unit, and the external device(s) may comprise all elements described above with reference to figs. 24a - 24d and fig. 24e. In some examples, the power supply may comprise an energy receiver 241 and an energy source 242 as discussed above in connection with figure 24a. The power supply may hence comprise an implantable or external energy storage unit 242, 40 for providing energy to the medical implant (for instance via the energy receiver 241), an energy provider 397 connected to the implantable energy storage unit 40 and connected to an energy consuming part of the implantable device 100, the energy provider 397 being configured to store energy to provide a burst of energy to the energy consuming part, wherein the energy provider 397 is configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical power during startup of the energy consuming part. The energy consuming part may for example include the controller or control unit, or the electrode arrangement of a stimulation device or a signal damping device.

Alternatively, the implantable device 100 may comprise a first implantable energy storage unit 40 for providing energy to an energy consuming part of the implantable device 100, a second implantable energy storage unit 397 connected to the implantable energy storage unit 40 and connected to the energy consuming part, wherein the second implantable energy storage unit 397 is configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical power during startup of the energy consuming part. The second implantable energy storage unit 397 has a higher energy density than the first implantable energy storage unit 40. By having a “higher energy density” it may be meant that the second implantable energy storage unit 397 has a higher maximum energy output per time unit than the first implantable energy storage unit 40. The second energy storage 397 may be an energy provider as discussed below.

The energy consuming part may be any part of the implantable device 100, such as a motor for powering the hydraulic pump, a valve, a processing or computing unit, a communication unit, a device for providing electrical stimulation to a tissue portion of the body of the patient, a CPU for encrypting information, a transmitting and/or receiving unit for communication with an external unit (not shown as part of the energy consuming part in the drawings, that is, the communication unit may be connected to the energy storage unit 40 and to the energy provider 397), a measurement unit or a sensor, a data collection unit, a solenoid, a piezo-electrical element, a memory metal unit, a vibrator, a part configured to operate a valve comprised in the medical implant, or a feedback unit.

In this way, an energy consuming part requiring a quick start or an energy consuming part which requires a high level or burst of energy for a start may be provided with sufficient energy. This may be beneficial as instead of having an idle component using energy, the component may be completely turned off and quickly turned on when needed. Further, this may allow the use of energy consuming parts needing a burst of energy for a startup while having a lower energy consumption when already in use. In this way, a battery or an energy storage unit having a slower discharging (or where a slower discharging is beneficial for the lifetime or health of the battery) may be used for the implant, as the extra energy needed for the startup is provided by the energy provider.

Energy losses may occur in a battery or energy storage unit of an implant if the battery or energy storage unit is discharged too fast. These energy losses may for example be in the form of heat, which may damage the battery or energy storage unit. By the apparatus described in these examples, energy may be provided from the battery or energy storage unit in a way that does not damage the battery or energy storage unit, which may improve the lifetime of the battery or energy storage unit and thereby the lifetime of the medical implant.

In some examples, the discharging from the implantable energy storage unit 40 during startup of the energy consuming part is slower than the energy needed for startup of the energy consuming part, i.e. the implantable energy storage unit 40 is configured to have a slower discharging than the energy needed for startup of the energy consuming part. That is, there is a difference between the energy needed by the energy consuming part and the energy the implantable energy storage unit 40 is capable of providing without damaging the implantable energy storage unit 40. In other words, a maximum energy consumption of the energy consuming part may be higher than the maximum energy capable of being delivered by the implantable energy storage unit 40 without causing damage to the implantable energy storage unit, and the energy provider 397 may be adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy storage unit 40. The implantable energy storage unit 40 may be configured to store a substantially larger amount of energy than the energy burst provider 397 but may be slower to charge.

The implantable energy storage unit 40 may be any type of energy storage unit suitable for an implant, such as a re-chargeable battery or a solid-state battery, such as a thionyl-chloride battery. The implantable energy storage unit 40 may be connected to the energy consuming part and configured to power the energy consuming part after it has been started using the energy provider 397.

The energy provider 397 may be any type of part configured to provide a burst of energy for the energy consuming part. In some examples, the energy provider 397 is a capacitor, such as a start capacitor, a run capacitor, a dual run capacitor or a supercapacitor. The energy provider 397 may be connected to the implantable energy storage unit 40 and be adapted to be charged using the implantable energy storage unit 40. In some examples, the energy provider may be a second energy provider 397 configured to be charged by the implantable energy storage unit 40 and to provide the energy consuming part with electrical energy. The implantable device 100 may further comprising a temperature sensor for sensing a temperature of the capacitor and the temperature sensor may be integrated or connected to the controller 300 such that the sensed temperature can be used as input for controlling the implantable device 100 or as feedback to be sent to an external device 320. A corresponding method for powering a medical implant may also be contemplated. The method comprises the steps of initiating an energy consuming part 302 of the implant, the energy consuming part being connected to an implantable energy storage unit 40, providing an initial burst of energy to the energy consuming part using an energy provider 397 connected to the implantable energy storage unit 40 and to the energy consuming part 302, the energy provider 397 being adapted to provide a burst of energy to the energy consuming part, and subsequently powering the energy consuming part 302 using the implantable energy storage unit 40.

In some examples, a maximum energy consumption of the energy consuming part is higher than the maximum energy capable of being delivered by the implantable energy storage unit 40 without causing damage to the implantable energy storage unit 40, and the energy provider 397 is adapted to deliver an energy burst corresponding to difference between the required energy consumption and the maximum energy capable of being delivered by the implantable energy storage unit 40. The energy consuming part may for instance be a control unit controlling the electrical stimulation or damping, a sensor, or a transceiver.

The method may further comprise the step of charging the energy provider 397 using the implantable energy storage unit 40.

Initiating an energy consuming part 302 may comprise transitioning a control unit of the medical implant from a sleep mode to an operational or active mode.

The implantable energy storage unit 40 may be adapted to be wirelessly charged and the implantable energy storage unit may be connected to an internal charger 395 for receiving wireless energy from an external device 320 via an external charger 396, and the method may comprise wirelessly charging the implantable energy storage unit 40. In some examples, the method comprises controlling a receipt of electrical power from an external energy storage unit at the internal charger 395. The internal energy storage unit 40 may be charged via the receipt of a transmission of electrical power from an external energy storage unit 396 by the internal charger 395.

Fig. 25a shows one embodiment of a system for charging, programming and communicating with the controller 300 of the implanted system 100. Fig. 25a further describes the communication and interaction between different external devices which may be devices held and operated by the patient, by the health care provider (HCP) or by the Dedicated Data Infrastructure (DDI), which is an infrastructure supplier for example by the manufacturer of the implanted medical device 100 or the external devices 320’, 320”, 320’”. The system of the embodiment of fig. 25a comprises three external devices 320’, 320”, 320’” capable of communicating with the controller 300.

The basic idea is to ensure the security of the communication with, and the operation of, the system 100 by having three external devices 320’, 320”, 320’” with different levels of authority. The lowest level of authority is given to the patient operated remote control 320”. The remote control, also referred to as external device 320” is authorized to operate functions of the implanted system 100 via the implanted controller 300, on the basis of patient input. The remote control 320” is further authorized to fetch some necessary data from the controller 300. The remote control 320” is only capable of operating the controller 300 by communicating with the software currently running on the controller 300, with the currently settings of the software. The next level of authority is given to the Patient External Interrogation Device (P-EID) 320”’, which is a charging and communication unit which is held by the patient but may be partially remotely operated by the Health Care Provider (HCP) (Usually a medical doctor with the clinic providing the treatment with help of the implanted system 1). The P-EID 320”’ is authorized to make setting changes by selecting pre-programmed steps of the software or hardware running on the controller 300 of the implanted system 100. The P-EID is remotely operated by the HCP, and receives input from the HCP, via the DDE

The highest level of authority is given to the HCP-EID 320’ and its controller, referred to as the HCP Dedicated Display Device (DDD). The HCP-EID 320’ is a charging and communication unit which may be located physically at the clinic of the HCP. The HCP-EID 320’ may be authorized to freely alter or replace the software running on the controller 300, when the patient is physically in the clinic of the HCP. The HCP-EID 320’ is controlled by the HCP DDD, which either may act on a “webview” portal from the HCP-EID or be a device closed down to any activities (which may include the absence of an internet connection) other than controlling and communicating with the HCP-EID. The webview portal does not necessarily mean internet based or HTML-protocol and the webview portal may be communicated over other communicating protocols such as Bluetooth or any other type of standard or proprietary protocol. The HCP DDD may also communicate with the HCP-EID over a local network or via Bluetooth or other standard or proprietary protocols.

Starting from the lowest level of authority, the patient remote control external device 320” beneficially may comprise a wireless transceiver 328 for communicating with the implanted system 100. The remote control 320” is capable of controlling the operation of the implanted system 100 via the controller 300, by controlling pre-set functions of the implantable system 1, e.g. for operating an active portion of the implanted system 100 for performing the intended function of the implanted system 1. The remote control 320” is able to communicate with the implanted system 100 using any standard or proprietary protocol designed for the purpose. In the embodiment shown in fig. 25a, the wireless transceiver 328 comprises a Bluetooth (BT) transceiver, and the remote control 320” is configured to communicate with implanted system 100 using BT. In an alternative configurations, the remote control 320” communicates with the implanted system 100 using a combination of Ultra-Wide Band (UWB) wireless communication and BT. The use of UWB technology enables positioning of the remote control 320” which can be used by the implanted system 100 as a way to establish that the remote control 320” is at a position in which the implanted system 100 and/or the patient can acknowledge as being correct, e.g. in the direct proximity to the medical device 100 and/or the patient, such as within reach of the patient and/or within 1 or 2 meters of the implanted system 1.

UWB communication may be performed by the generation of radio energy at specific time intervals and occupying a large bandwidth, thus enabling pulse-position or time modulation. The information can also be modulated on UWB signals (pulses) by encoding the polarity of the pulses, their amplitude and/or by using orthogonal pulses. A UWB radio system can be used to determine the "time of flight" of the transmission at various frequencies. This helps overcome multipath propagation, since some of the frequencies have a line-of-sight trajectory, while other indirect paths have longer delay. With a cooperative symmetric two-way metering technique, distances can be measured at high resolution and accuracy. UWB is useful for real-time location systems, and its precision capabilities and low power make it well-suited for radio-frequency-sensitive environments, such as health care environments.

In embodiments in which a combination of BT and UWB technology is used, the UWB technology may be used for location-based authentication of the remote control 320”, whereas the communication and/or data transfer could take place using BT or any other way of communicating different from the UWB. The UWB signal could in some embodiments also be used as a wake-up signal for the controller 300, or for the BT transceiver, such that the BT transceiver in the implanted system 100 can be turned off when not in use, which eliminates the risk that the BT is intercepted, or that the controller 300 of the implanted system 100 is hacked by means of BT communication. In embodiments in which a BT (or alternatives) / UWB combination is used, the UWB connection may be used also for the transmission of data. In the alternative, the UWB connection could be used for the transmission of some portions of the data, such as sensitive portions of the data, or for the transmission of keys for the unlocking of encrypted communication sent over BT.

The remote control 320” comprises a computing unit 326 configured to run a software application for communicating with the implanted system 1. The computing unit 326 can receive input directly from control buttons 335 arranged on the remote control 320” or may receive input from a control interface 334i displayed on a patient display device 334 operated by the patient. In the embodiments in which the remote control 320” receives input from a control interface 334i displayed on the patient display device 334 operated by the patient, the remote control 320” may transmit the control interface 334i in the form of a web-view portal, i.e. a remote interface running in a sandbox environment on the patient’s display device 334. A sandbox environment is understood as running on the display device 334 but only displaying what is presented from the remote control, and only using a tightly controlled set of commands and resources, such as storage and memory space as well as network access. The ability to inspect the host system and read or write from other input devices connected to the display device 334 may therefore be extremely limited. Any action or command generated by the patient display device may be similar to controlling a webpage. All acting software may be located on the remote control that only displays its control interface onto the patient display unit.

The computing unit 326 may further be configured to encrypt the control interface before transmission to the patient display device 334, and encrypt the control commands before transmission to the implanted system 1. The computing unit 326 is further configured to transform the received user input into control commands for wireless transmission to the implantable system 1.

The patient’s display device 334 could for example be a mobile phone, a tablet or a smart watch. In the embodiment shown in fig. 25a, the patient’s display device 334 communicates with the remote control 320” by means of BT. The control interface 334i in the form of a web-view portal is transmitted from the remote control 320” to the patient’s display device 334 over BT. Control commands in the form of inputs from the patient to the control interface 334i may be transmitted from the patient’s display device 334 to the remote control 320”, providing input to the remote control 320” equivalent to the input that may be provided using the control buttons 335. The control commands created in the patient’s display device 334 may be encrypted in the patient’s display device 334 and transmitted to the remote control 320’ using BT or any other communication protocol.

The remote control may normally not be connected to the DDI or the Internet, thereby increasing security. In addition, the remote control 320” may in one embodiment have its own private key. In a specific embodiment, the remote control 320” may be activated by the patient’s private key for a certain time period. This may activate the function of the patient’s display device and the remote wed-view display portal supplied by the remote control to the patient’s display device.

The patient’s private key may be supplied in a patient private key device compromising a smartcard that may be inserted or provided close to the remote control 320” to activate a permission to communicate with the implant 100 for a certain time period.

The patient’s display device 334 may (in the case of the display device 334 being a mobile phone or tablet) comprise auxiliary radio transmitters for providing an auxiliary radio connection, such as a Wi-Fi or mobile connectivity (e.g. according to the 3G,4G or 5G standards). The auxiliary radio connection(s) may have to be disconnected to enable communication with the remote control 320”. Disconnecting the auxiliary radio connections reduces the risk that the integrity of the control interface 334i displayed on the patient’s display device 334 is compromised, or that the control interface 334i displayed on the patient’s display device 334 is remotely controlled by an unauthorized device or entity.

In alternative embodiments, control commands are generated and encrypted by the patient’s display device and transmitted to the DDI 330. The DDI 330 could either alter the created control commands to commands readable by the remote control 320” before further encrypting the control commands for transmission to the remote control 320”, or could simply add an extra layer of encryption before transmitting the control commands to the remote control 320”, or could simply act as a router for relaying the control commands from the patients’ display device 334 to the remote control 320” . It is also conceivable that the DDI 330 adds a layer of end-to-end encryption directed at the implanted system 1, such that only the implanted system 100 can decrypt the control commands to perform the commands intended by the patient. In the embodiments above, when the patient remote display device 334 is communicating with the DDI, the patient’s display device 334 may be configured to only display and interact with a web-view portal provided by a section of the DDI. It is conceivable that the web-view portal is a view of a back-end provided on the DDI 330, and that in such embodiments the patient interacting with the control interface on the patient’s display device 334 is equivalent to the patient interacting with an area of the DDI 330.

The patient’s display device 334 could have a first and second application related to the implanted system 1. The first application is the control application displaying the control interface 334i for control of the implanted system 1, whereas the second application is a general application for providing the patient with general information of the status of the implanted system 100 or information from the DDI 330 or HCP, or for providing an interface for the patient to provide general input to the DDI 330 or HCP related to the general wellbeing of the patient, the lifestyle of the patient or related to general input from the patient concerning the function of the implanted system 1. The second application, which do not provide input to the remote control 320” and/or the implanted system 100 thus handles data which is less sensitive. As such, the general application could be configured to function also when all auxiliary radio connections are activated, whereas switching to the control application which handles the more sensitive control commands and communication with the implanted system 100 could require that the auxiliary radio connections are temporarily de-activated. It is also conceivable that the control application is a sub-application running within the general application, in which case the activation of the control application as a sub-application in the general application could require the temporary de-activation of auxiliary radio connections. In the embodiment shown in fig. 25a, access to the control application requires the use of the optical and/or NFC means of the hardware key 333’ in combination with biometric input to the patient’s display device, whereas accessing the general application only requires biometric input to the patient’s display device and/or a pin code. In an example, a two-factor authentication solution, such as a digital key in combination with a pin code could be used for accessing the general application and/or the control application.

In general, a hardware key may be needed to activate the patient display device 334 for certain time period to control the web-view portal of the remote control 320”, displaying the control interface 334i for control of the implanted system 1. In the embodiments in which the patients display device 334 is configured to only display and interact with a web-view provided by another unit in the system, it is conceivable that the webview portal is a view of a back-end provided on the DDI 330, and in such embodiments, the patient interacting with the control interface on the patient’s display device is equivalent to the patient interacting with an area of the DDI 330.

Moving now to the P-EID 320’”. The P-EID 320’” is an external device used by the patient, patient external device, configured to communicate with, and charge, the implanted system 1. The P-EID 320’” can be remotely controlled by the HCP to read information from the implanted system 1. The P-EID 320’” is adapted to control the operation of the implanted system 1, control the charging of the implantable system 1, and adjust the settings on the controller 300 of the implanted system 100 by changing pre-defined pre-programmed steps and/or by the selection of pre-defined parameters within a defined range.

Similar to the remote control 320”, the P-EID 320” ’ may be configured to communicate with the implanted system 100 using BT or UWB communication or any other proprietary or standard communication method. Since the device may be used for charging the implant, the charging signal and communication could be combined. Similar to the remote control 320”, it is also possible to use a combination of UWB wireless communication and BT for enabling positioning of the P-EID 320” as a way to establish that the P-EID 320” is at a position which the implanted system 100 and/or patient and/or HCP can acknowledge as being correct, e.g. in the direct proximity to the correct patient and/or the correct system 1. Just as for the remote control 320”, in embodiments in which a combination of BT and UWB technology is used, the UWB technology may be used for location-based authentication of the P-EID 320”, whereas the communication and/or data transfer could take place using BT. The P-EID 320” comprises a wireless transmitter/transceiver 328 for communication and also comprises a wireless transmitter 325 configured for transferring energy wirelessly, which may be in the form of a magnetic field or any other signal such as electromagnetic, radio, light, sound or any other type of signal to transfer energy wirelessly to a wireless receiver 395 of the implanted system 1. The wireless receiver 395 of the implanted system 100 is configured to receive the energy in the form of the magnetic field and transform the energy into electric energy for storage in an implanted energy storage unit 40, and/or for consumption in an energy consuming part of the implanted system 100 (such as the operation device, controller 300 etc.). The magnetic field generated in the P-EID 320’” and received in the implanted system 100 is denoted charging signal. In addition to enabling the wireless transfer of energy from the P-EID 320’” to the implanted system 1, the charging signal may also function as a means of communication. E.g., variations in the frequency of the transmission, and/or the amplitude of the signal may be uses as signaling means for enabling communication in one direction, from the P-EID 320’” to the implanted system 1, or in both directions between the P-EID 320’” and the implanted system 1. The charging signal in the embodiment shown in fig. 25a is a signal in the range 10 - 65kHz or 115 - 140 kHz and the communication follow a proprietary communication signaling protocol, i.e., it is not based on an open standard. In alternative embodiments, BT could be combined with communication using the charging signal, or communication using the charging signal could be combined with an UWB signal. The energy signal could also be used as a carrying signal for the communication signal.

Just as for the remote control 320”, the UWB signal could in some embodiments also be used as a wake-up signal for the controller 300, or for the BT transceiver, such that the BT transceiver in the implanted system 100 can be turned off when not in use, which eliminates the risk that the BT is intercepted, or that the controller 300 of the implanted system 100 is hacked by means of BT communication. In some examples, the charging signal could be used as a wakeup signal for the BT, as the charging signal does not necessarily travel very far. Also, as a means of location-based authentication, the effect of the charging signal or the RSSI could be assessed by the controller 300 in the implanted system 100 to establish that the transmitter is within a defined range. In the BT/UWB combination, the UWB may be used also for transmission of data. In some embodiments, the UWB and/or the charging signal could be used for the transmission of some portions of the data, such as sensitive portions of the data, or for the transmission keys for unlocking encrypted communication sent by BT. Wake-up could be performed with any other signal.

UWB could also be used for waking up the charging signal transmission, to start the wireless transfer of energy or for initiating communication using the charging signal. As the signal for transferring energy has a very high effect in relation to normal radio communication signals, the signal for transferring energy cannot be active all the time, as this signal may be hazardous e.g., by generating heat.

The P-EID 320”’ may communicate with the HCP over the Internet by means of a secure communication, such as over a VPN. The communication between the HCP and the P-EID 320”’ is preferably encrypted. Preferably, the communication is sent via the DDI, which may only be relaying the information. The communication from the HCP to the implanted system 100 may be performed using an end-to-end encryption, in which case the communication cannot be decrypted by the P-EID 320’”. In such embodiments, the P-EID 320’” acts as a router, only passing on encrypted communication from the HCP to the controller 300 of the implanted system 100 (without full decryption). This solution further increases security as the keys for decrypting the information rests only with the HCP and with the implanted system 1, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device. The P-EID 320’” may add own encryption or information, specifically for security reasons. The P-EID 320’” may hold its own private key and may be allowed to communicate with the implant 100 based on confirmation from the patient’s private key, which may be provided as a smartcard to be inserted in a slot of the P-EID 320’” or hold in close proximity thereto to be read by the P-EID 320’”. These two keys will add a high level of security to the performed communication between the implanted system 100 and the P-EID 320”’ since the patient’s hardware key in this example on the smartcard may activate and thereby allow the communication and action taken in relation to the system 1. The P-EID 320’” may as previously described change the treatment setting of the system 100 by selecting preprogrammed steps of the treatment possibilities. Such pre-programmed treatment options may include for example to change: at least one of the level of constriction, pressure or position of a hydraulic, mechanic, and/or electric stimulation device, the volume of an operable volume filling device employed to adjust a cuff arranged at the renal artery, parameters of an implant communicating with a database outside the body, such as key handshake, new key pairing, signal amplitude etc., parameters of an implant able to be programmed from outside the body, parameters of an implant able to be programmed from outside the body with a wireless signal,

When the implanted medical device 100 is to be controlled and/or updated remotely by the HCP, via the P-EID 320’”, a HCP Dedicated Device (DD) 332 displays an interface in which predefined program steps or setting values are presented to the HCP. The HCP provides input to the HCP DD 332 by selecting program steps, altering settings and/or values or by altering the order in which pre-defined program steps is to be executed. The instructions/parameters inputted into the HCP DD 332 for remote operation is in the embodiment shown in fig. 25a routed to the P-EID 320’” via the DDI 330, which may or may not be able to decrypt/read the instructions. The DDI 330 may store the instructions for a time period to later transfer the instructions in a package of created instructions to the P-EID 320’”. It is also conceivable that an additional layer of encryption is provided to the package by the DDI 330. The additional layer of encryption may be a layer of encryption to be decrypted by the P-EID 330, or a layer of encryption which may only be decrypted by the controller 300 of the implanted system 1, which reduces the risk that unencrypted instructions or packages are intercepted by unauthorized devices. The instructions/parameters are then provided to the P-EID 320”, which then loads the instructions/parameters into the during the next charging/energy transfer to the implanted system 100 using any of the signal transferring means (wireless or conductive) disclosed herein.

The Health Care Provider EID (HCP EID) 320’ have the same features as the P- EID 320” and can communicate with the implanted system 100 in the same alternative ways (and combinations of alternative ways) as the P-EID 320’”. However, in addition, the HCP EID 320’ also enables the HCP to freely reprogram the controller 300 of the implanted system 1, including replacing the entire program code running in the controller 300. The idea is that the HCP EID 320’ always remain with the HCP and as such, all updates to the program code or retrieval of data from the implanted system 100 using the HCP EID 320’ is performed with the HCP and patient present

(i.e. not remote). The physical presence of the HCP is an additional layer of security for these updates which may be critical to the function of the implanted system 1.

In the embodiment shown in fig. 25a, the HCP communicates with the HCP EID 320’ using a HCP Dedicated Display Device 332 (HCP DDD), which is a HCP display device comprising a control interface for controlling and communicating with the HCP EID 320’. As the HCP EID 320’ always stays physically at the HCP’s clinic, communication between the HCP EID 320’ and HCP DDD 332 does not have to be sent over the Internet. Instead, the HCP DDD 332 and the HCP EID 320’ can communicate using one or more of BT, a proprietary wireless communication channel, or a wired connection. The alteration to the programming is then sent to the implanted system 100 directly via the HCP EID 320’. Inputting into the HCP DDD 332 for direct operation by means of the HCP EID 320’ is the same as inputting directly into the HCP EID 320’, which then directly transfers the instructions into the implanted system 1.

In the embodiment shown in fig. 25a, both the patient and the HCP has a combined hardware key 333’, 333”. The combined keys 333’, 333” comprises a hardware component comprising a unique circuitry (providing the highest level of security), a wireless NFC-transmitter 339 for transmitting a specific code (providing mid-level security), and a printed QR-code 344 for optical recognition of the card (providing the lowest level of security). The HCP private key is supplied by a HCP private key device 333” adapted to be provided to the HCP EID external device via at least one of; a reading slot or comparable for the HCP private key device 333”, an RFID communication or other close distance wireless activation communication to both the HCP EID 320’ and the HCP DDD 332 if used. The HCP DDD 332 will be activated by such HCP private key device 333”, which for example may comprise at least one of, a smartcard, a key-ring device, a watch an arm or wrist band a neckless or any shape device.

The HCP EID external device may comprise at least one of; a reading slot or comparable for the HCP private key device, an RFID communication and other close distance wireless activation communication means The HCP external device 320’ may further comprise at least one wireless transceiver 328 configured for communication with a data infrastructure server, DDI, through a first network protocol.

A dedicated data infrastructure server, DDI, is in one embodiment adapted to receive commands from said HCP external device 320’ and may be adapted to rely the received commands without opening said commands directed to the patient external device 320”, the DDI 330 comprising one wireless transceiver configured for communication with said patient external device 320”. The patient EID external device 320” is in one embodiment adapted to receive the commands relayed by the DDI, and further adapted to send these commands to the implanted medical device 100, which is adapted to receive commands from the HCP, Health Care Provider, via the DDI 330 to change the pre-programmed treatment steps of the implanted system 1. The patient EID is adapted to be activated and authenticated and allowed to perform the commands by the patient providing a patient private key device 333’. The patient’s private key device is in one embodiment adapted to be provided to the patient external device by the patient via at least one of; a reading slot or comparable for the patient private key device 333’, an RFID communication or other close distance wireless activation communication.

The patient EID external device, in one or more embodiments, comprises at least one of; a reading slot or comparable for the HCP private key device, an RFID communication, or other close distance wireless activation communication

The patient EID external device may in one or more embodiments comprise at least one wireless transceiver configured for communication with the implanted system 100 through a second network protocol.

The patient’s key 333’ is in the embodiment shown in fig. 25a in the form of a key card having an interface for communicating with the P-EID 320’”, such that the key card could be inserted into a key card slot in the P-EID 320”. The NFC-transmitter 339 and/or the printed QR- code 344 can be used as means for accessing the control interface 334i of the display device 334. In addition, the display device 334 may require a pin-code and/or a biometric input, such as face recognition or fingerprint recognition.

The HCP’s key 333”, in the embodiment shown in fig. 25a is in the form of a key card having an interface for communicating with the HCP -EID 320’, such that in one embodiment the key card could be inserted into a key card slot in the HCP -EID 320’. The NFC-transmitter 339 and/or the printed QR-code 344 can be used as means for accessing the control interface of the HCP DDD 332. In addition, the HCP DDD 332 may require a pin-code and/or a biometric input, such as face recognition or fingerprint recognition.

In alternative embodiments, it is however conceivable that the hardware key solution is replaced by a two-factor authentication solution, such as a digital key in combination with a PIN code or a biometric input (such as face recognition and/or fingerprint recognition). The key could also be a software key, holding similar advance key features, such as the Swedish Bank ID being a good example thereof.

In the embodiment shown in fig. 25a, communication over the Internet takes place over a Dedicated Data Infrastructure (DDI) 330, running on a cloud service. The DDI 330 in this case handles communication between the HCP DDD 332 and the P-EID 320’”. however, the more likely scenario is that the HCP DDD 332 is closed down, such that only the necessary functions of the control application can function on the HCP DDD 332. In the closed down embodiment, the HCP DDD 332 is only able to give the necessary commands to HCP EID 320’ to further update the pre-programmed treatment steps of the Implant 100 via the P-EID 320’” in direct contact, or more likely indirect contact via the DDI 332. If the patient is present locally, the HCP EID may communicate and act directly on the patient’s implant. However, before anything is accepted by the implant, a patient private key device 333’ has to be presented to the P EID 320’” or HCP EID 320’ for maximum security.

The DDI 330 is logging information of the contact between the HCP and the remote control 320” via implant feedback data supplied from the implant to P-EID 320” ’ . Data generated between the HCP and the patient’s display device 334, as well as between the HCP and auxiliary devices 336 (such as tools for following up the patient’s treatments e.g. a blood pressure monitor) are logged by the DDI 330. In some embodiments, although less likely, the HCP DDD 332 may also handle the communication between the patient’s display device 334 and the remote control 320”. In fig. 25a, auxiliary devices 336 are connected to the P-EID as well and can thus provide input from the auxiliary devices 336 to the P-EID which can be used by the P-EID for altering the treatment or for follow up.

In all examples, the communication from the HCP to: the P-EID 320’”, the remote control 320”, the patient’s display device 334 and the auxiliary devices 336 may be performed using an end-to-end encryption. In embodiments with end-to-end encryption, the communication cannot be decrypted by the DDI 330. In such embodiments, the DDI 330 acts as a router, only passing on encrypted communication from the HCP to various devices. This solution further increases security as the keys for decrypting the information rests only with the HCP and with the device sending or receiving the communication, which reduces the risk that an unencrypted signal is intercepted by an unauthorized device. The P-EID 320’” may also only pass on encrypted information.

In addition to acting as an intermediary or router for communication, the DDI 330 collects data on the implanted medical device 100, relating to the treatment and to the patient. The data may be collected in an encrypted form, in an anonymized form or in an open form. The form of the collected data may depend on the sensitivity of the data or on the source from which the data is collected. In the embodiment shown in fig. 25a, the DDI 330 sends a questionnaire to the patient’s display device 334. The questionnaire could comprise questions to the patient related to the general health of the patient, related to the way of life of the patient, or related specifically to the treatment provided by the implanted system 100 (such as for example a visual analogue scale for measuring pain). The DDI 330 could compile and/or combine input from several sources and communicate the input to the HCP which could use the provided information to create instructions to the various devices to be sent back over the DDI 330. The data collection performed by the DDI 330 could also be in the form a log to make sure that all communication between the units in the system can be back traced. Logging the communication ensures that all alterations to software or the settings of the software, as well as the frequency and operation of the implanted system 100 can be followed. Following the communication enables the DDI 330 or the HCP to follow the treatment and react it something in the communication indicates that the treatment does not provide the intended results or if something appears to be wrong with any of the components in the system. If patient feedback from the patient display device 334 indicates that a new treatment step of the implant is needed, such information must be confirmed by direct contact between HCP and patient.

In the specific embodiment disclosed in fig. 25a, the wireless connections between the different units are as follows. The wireless connection 411 between the auxiliary device 336 and the DDI 330 is based on WiFi or a mobile telecommunication regime or may be sent to the DDI 330 via the P-EID 320”’ and the wireless connection 411 between the auxiliary device 336 and the patient’s display device 334 is based on BT or any other communication pathway disclosed herein. The wireless connection 412 between the patient’s display device 334 and the DDI 330 is based on WiFi or a mobile telecommunication regime. The wireless connection 413 between the patient’s display device 334 and the remote control 320” is based on BT or any other communication pathway disclosed herein. The wireless connection 414 between the patient remote control 320” and the implanted system 100 is based on BT and UWB or any other communication pathway disclosed herein. The wireless connection 415 between the remote control 320” and the DDI 330 is likely to not be used, and if present be based on WiFi or a mobile telecommunication regime. The wireless connection 416 between the P-EID 320’” and the implanted system 100 is based on BT, UWB and the charging signal or any other communication or energizing pathway disclosed herein. The wireless connection 417 between the P-EID 320’” and the DDI 330 is based on WiFi or a mobile telecommunication regime. The wireless connection 418 between the HCP -EID 320’ and the implanted system 100 is based on at least one of the BT, UWB and the charging signal. The wireless connection 419 between the P-EID 320’” and the HCP DD 332 is based on BT or any other communication path disclosed herein. The wireless connection 420 between the HPC-EID 320’ and the DDI 330 is based on WiFi or a mobile telecommunication regime. The wireless connection 421 between the HPC DD 332 and the DDI 330 is normally closed and not used and if so based on WiFi or a mobile telecommunication regime. The wireless connection 422 between the HCP-EID 320’ and the HCP DD 332 is based on at least one of BT, UWB, local network or any other communication path disclosed herein.

The wireless connections specifically described in the embodiment shown in fig. 25a may however be replaced or assisted by wireless connections based on radio frequency identification (RFID), near field communication (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The mobile telecommunication regimes may for example be 1G, 2G, 3G, 4G, or 5G. The wireless connections may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), or quadrature amplitude modulation (QAM). The wireless connection may further feature technologies such as time-division multiple access (TDMA), frequency-division multiple access (FDMA), or codedivision multiple access (CDMA). The wireless connection may also be based on infra-red (IR) communication. The wireless connection may feature radio frequencies in the high frequency band (HF), very-high frequency band (VHF), and the ultra-high frequency band (UHF) as well as essentially any other applicable band for electromagnetic wave communication. The wireless connection may also be based on ultrasound communication to name at least one example that does not rely on electromagnetic waves.

Fig. 25a’ also discloses a master private key 333 ” ’ device that allow issuance of new private key device wherein the HCP or HCP admin have such master private key 333’” device adapted to be able to replace and pair a new patient private key 333’ device or HCP private key device 333” into the system, through the HCP EID external device 320’.

A system configured for changing pre-programmed treatment settings of an implantable system 1, when implanted in a patient, from a distant remote location in relation to the patient, will be discussed in the following.

Fig. 25a’ discloses a scenario in which at least one health care provider, HCP, external device 320’ is adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted system 1, further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333”. The HCP EID external device 320’ further comprising at least one wireless transceiver 328 configured for communication with a patient EID external device 320” ’, through a first network protocol. The system comprises the patient EID external device 320’”, the patient EID external 320’” device being adapted to receive command from said HCP external device 320’, and to relay the received command without modifying said command to the implanted system 1. The patient EID external device 320’” comprises a wireless transceiver 328. The patient EID 320’” is adapted to send the command to the implanted system 1, to receive a command from the HCP to change said preprogrammed treatment settings of the implanted system 1, and further to be activated and authenticated and allowed to perform said command by the patient providing a patient private key 333’ device comprising a patient private key.

Although wireless transfer is primarily described in the embodiment disclosed with reference to figs. 25a’ the wireless communication between any of the external device may be substituted for wired communication. Also, some or all of the wireless communication between an external device and the implanted system 100 may be substituted for conductive communication using a portion of the human body as conductor.

Fig. 25b shows a portion of fig. 25a, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 25b, the system is configured for changing pre-programmed treatment settings of an implantable system 1, when implanted in a patient, from a distant remote location in relation to the patient. The system of fig. 25b comprises at least one HCP EID 320’ external device adapted to receive commands from the HCP to change said pre-programmed treatment settings of an implanted system 1. The HCP EID 320’ external device is further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333” adapted to be provided to the HCP EID external device 320’. The private key device 333” is adapted to be provided to the HCP EID external device 320’ via at least one of: a reading slot or comparable for the HCP private key device 333”, and an RFID communication or other close distance wireless activation communication.

The HCP EID external device 320’ comprises at least one of: a reading slot or comparable for the HCP private key device 333”, an RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device 320’ further comprises at least one wireless transceiver 328 configured for communication with a dedicated data infrastructure server (DDI) 330, through a first network protocol. The system further comprises a dedicated data infrastructure server (DDI) 330, adapted to receive command from said HCP EID external device 320’, adapted to relay the received commands without modifying said command to a patient EID external device 320’”. The dedicated data infrastructure server (DDI) 330 further comprises a wireless transceiver 328 configured for communication with said patient external device. The system further comprises a patient EID external device 320”’ adapted to receive the command relayed by the dedicated data infrastructure server (DDI) 330 and further adapted to send commands to the implanted system 100 and further adapted to receive commands from the HCP EID external device 320’ via the dedicated data infrastructure server (DDI) 330 to change said preprogrammed treatment settings of the implanted system 1. The patient EID external device 320’” may further be adapted to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device 333’, which may be adapted to be provided to the patient EID external device 320’” by the patient via at least one of: a reading slot or comparable for the patient private key device 333’, an RFID communication or other close distance wireless activation communication or electrical direct contact. The patient EID external device 320’” further comprises at least one of: a reading slot or comparable for the HCP private key device, an RFID communication and other close distance wireless activation communication or electrical direct contact. The patient EID external device 320’” further comprises at least one wireless transceiver 328 configured for communication with the implanted system 100 through a second network protocol. The implanted system 100 is in turn configured to treat the patient or perform a bodily function.

The scenario described with reference to fig. 25b may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 25c - 25e. Fig. 25c shows a portion of fig. 25a, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 25c, a system configured for changing pre-programmed treatment settings of an implantable system 100 is disclosed. The changing of the pre-programmed treatment settings is performed by a health care provider (HCP) in the physical presence of the patient. The system comprises at least one HCP EID external device 320’ adapted to receive commands from the HCP, directly or indirectly, to change said pre-programmed treatment settings in steps of an implantable system 1, when implanted. The HCP EID external device 320’ is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing a HCP private key device 333” comprising a HCP private key. The HCP private key device in the embodiment of fig. 25c comprises at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device. The HCP EID external device 320’ is adapted to be involved in at least one of: receiving information from the implant 100, receiving information from a patient remote external device 336, actuating the implanted system 1, changing pre-programmed settings, and updating software of the implantable system 1, when implanted. The HCP EID external device 320’ is adapted to be activated, authenticated, and allowed to perform said command also by the patient, the system comprises a patient private key device 333’ comprising a patient private key. The patient private key device 333’ may comprise at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device. The HCP private key 333” and the patient’s private key may be required for performing said actions by the HCP EID external device 320’ to at least one of: receive information from the implant 100, to receive information from a patient remote external device 336, to actuate the implanted system 1, to change pre-programmed settings, and to update software of the implantable system 1, when the implantable system 100 is implanted.

Fig. 25c also outlines a scenario in which the system is configured for changing preprogrammed treatment settings in steps of an implantable medical device, when implanted in a patient, by a health care provider, HCP, wherein the patient may be located at a remote location, or on a distance. The system may comprise: at least one HCP EID external device 320’ adapted to receive a command from the HCP, directly or indirectly, to change said pre-programmed treatment settings in steps of an implanted medical device The HCP EID external device 320’ is further adapted to be activated, authenticated, and allowed to perform said command by the HCP. The action by the HCP EID external device 320’ to change pre-programmed settings in the implant 100 and to update software of the implantable medical device 100, when the implantable medical device 100 is implanted, is adapted to be authenticated by a HCP private key device 333” and a patient private key device 333’.

The scenario described with reference to fig. 25c may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 25b, or 25d - 25e. Fig. 25d shows a portion of fig. 25a, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 25d, a system configured to change pre-programmed and pre-selected treatment actions of an implantable system 100 by a command from the patient is described. The system comprises an implantable system 1, a patient remote external device 320”, and a wireless transceiver 328 configured for communication with the implantable system 1, when the system 100 is implanted, through a second network protocol. The system further comprises a remote display portal interface 334i configured to receive content delivered from the patient remote external device 320” to expose buttons to express the will to actuate the functions of the implanted system 100 by the patient through the patient remote external device 320”. The remote external device 320” is further configured to present the display portal remotely on a patient display device 334 allowing the patient to actuate the functions of the implanted system 100 through the display portal of the patient remote external device 320” visualised on the patient display device 334. In fig. 25d, a further wireless connection 423 between the patient remote external device 320” and the patient EID external device 320”’ is provided. This further wireless connection 423 could be a wireless connection according to any one of the wireless signaling methods and protocols described herein, and the communication can be encrypted.

The scenario described with reference to fig. 25d may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 25b, 25c, or 25e.

Fig. 25e shows a portion of fig. 25a, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 25e, a system configured for providing information from an implantable medical system 1, when implanted in a patient, from a distant remote location in relation to the patient is described. The system comprises at least one patient EID external device 320”’ adapted to receive information from the implant 100, and to send such information further on to a server or dedicated data infrastructure, DDI, 330. The patient EID external device 320’” is further adapted to be activated and authenticated and allowed to receive said information from the implanted system 100 by the patient providing a private key. The patient private key device comprises the private key adapted to be provided to the patient EID external device 320’” via at least one of: a reading slot or comparable for the patient private key device, an RFID communication or other close distance wireless activation communication or direct electrical connection, The patient EID external device 320’” comprises at least one of: a reading slot or comparable for the patient private key device, an RFID communication and other close distance wireless activation communication or direct electrical contact. The patient EID external device 320’” further comprises at least one wireless transceiver 328 configured for communication with the DDI 330, through a first network protocol. The scenario described with reference to fig. 25e may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 25b - 25d.

Fig. 25f shows a portion of fig. 25a, in which some of the components have been omitted to outline a specific scenario. In the scenario outlined in fig. 25f a system configured for changing pre-programmed treatment settings in steps of an implantable system 1, when implanted in a patient, by a health care provider, HCP, either in the physical presence of the patient or remotely with the patient on distance is described. The system comprises at least one HCP EID external device 320’ adapted to receive a command directly or indirectly from the HCP to change said preprogrammed treatment settings in steps of the implantable system 1, when implanted, wherein the HCP EID external device 320’ is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing a HCP private key device comprising a HCP private key. The HCP private key comprises at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device. The system further comprises a patient private key device comprising a patient private key comprising at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device. Both the HCP and patient private key is required for performing said action by the HCP EID external device 320’ to change the pre-programmed settings in the system 100 and to update software of the implantable system 1, when the implantable system 100 is implanted. The patient private key is adapted to activate, be authenticated, and allowed to perform said command provided by the HCP, either via the HCP EID external device or when the action is performed remotely via a patient EID external device 320’. In the embodiment shown in fig. 25f, the communication is routed over the DDI server 330.

The scenario described with reference to fig. 25f may in alternative embodiments be complemented with additional units or communication connections, or combined with any of the scenarios described with reference to figures 25b - 25e.

Fig. 25g shows an overview of an embodiment of the system, similar to the one described with reference to fig. 25a, the difference being that the HCP EID and the HCP DDD are combined into a single device.

Fig. 25h shows an overview of an embodiment of the system, similar to that described with reference to fig. 25a, the difference being that the HCP EID external device 320’” and the HCP DDD 332 are combined into a single device and the P-EID external device 320”’ and the patient remote control external device 320” are combined into a single device.

One probable scenario / design of the communication system is for the purpose of changing pre-programmed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient. The system comprises at least one health care provider, HCP, external device 320’ adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted system 1. The HCP external device 320 ‘ is further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device 333”, which may be adapted to be provided to an HCP EID external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication or other close distance wireless activation communication. The HCP EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact. The HCP EID external device further comprises at least one wireless transceiver configured for communication with a patient EID external device, through a first network protocol, wherein the system comprises the patient EID external device, the patient EID external device being adapted to receive command from said HCP external device, and to relay the received command without modifying said command to the implanted medical device. The patient EID external device comprising one wireless transceiver configured for communication with said patient external device. The patient EID is adapted to send the command to the implanted medical device, to receive a command from the HCP to change said pre-programmed treatment settings of the implanted medical device, and further to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device comprising a patient private key.

Although the different scenarios outlined in figures 25b - 25h are described with specific units and method of signaling, these scenarios may very well be combined with each other or complemented with additional units or communication connections. The embodiments described herein may advantageously be combined.

A computer program product of, or adapted to be run on, an internal computing unit or an external device is also provided, which comprises a computer-readable storage medium with instructions adapted to make the internal computing unit and/or the external device perform the actions as described in any embodiment or example above.

Figure 26 shows a frontal view of the abdomen of the patient when the medical device 100 according to any of above described embodiments, such as the electrical stimulation device 110 and/or the signal damping device 120 shown in figures 4-8, or the entire system, or parts of the system, shown in figure 11, has been implanted. This is however only an example of an embodiment and it is clear that any of the embodiments of the medical device disclosed herein can be implanted and connected in the manner described with reference to figure 26. The medical device 100 is in the embodiment shown in figure 26 operated by a remote unit 140 which in the embodiment shown in figure 26 may correspond to the remote unit 140 of the embodiments discussed above in connection with figures 24a-f and 25. This is however only an example of a remote unit for operation of the medical device 100 and it is clear that any of the embodiments of remote units disclosed herein can be implanted and connected in the manner described with reference to figure 26.

The remote unit 140 may comprise a first unit 141 ', a second unit 141”, and a connecting portion 142, mechanically connecting the first and second units 141’, 141”. The first unit 141’ is in the embodiment shown in fig. 26 placed on the inside of muscular tissue MT of the abdominal wall AW of the patient, whereas the second unit 141 ” is placed on the outside of the muscular tissue MT of the abdominal wall AW, in the subcutaneous tissue ST. As such, the connecting portion 142 travels through a created hole in, or natural orifice between, the muscles of the muscular tissue MT. A cross-sectional area of the connecting portion 142, in a plane in the extension of the muscular tissue MT is smaller than a cross-sectional area of the first and second units 141 ’,141”, parallel to the cross-sectional area of the connecting portion 142. The cross-sectional areas of the first and second units 141 ’, 141 ” are also larger than the created hole or natural orifice though which the connecting portion 142 is placed. As such, the first and second units 141 ’,141” are unable to pass through the created hole or natural orifice and is as such fixated to the muscular tissue MT of the abdominal wall. This enables the remote unit 140 to be suspended and fixated to the muscle tissue MT of the abdominal wall AW.

In the embodiment shown in fig. 26, the connecting portion 142, is a connecting portion 142 having a circular cross-section and an axial direction AD extending from the first unit 141’ to the second unit 141”. The plane in the extension of the muscular tissue MT, is in the embodiment of fig. 26 perpendicular to the axial direction AD of the connecting portion 142 extending from the first unit 141’ to the second unit 141”.

As is further described with reference to fig. 26, the controller may be placed in the first unit 141’, and the implantable energy storage unit is placed in the second unit 141”. The controller and the implantable energy storage unit are electrically connected to each other by means of a lead running in the connecting portion 142, such that electrical energy and communication can be transferred from the second 141” to the first unit 141’, and vice versa. In the embodiment of fig. 26, the second unit 141” may further comprise a wireless energy receiver for receiving wireless energy for charging the implantable energy storage unit and/or for powering the medical device 100, and a transceiver for receiving and/or transmitting wireless signals to/from the outside the body. Further features and functions of the controller and the implantable energy storage unit are further described above reference to figs. 24a-f and 25.

The abdominal wall AW is in most locations generally formed by a set of layers of skin, fat/fascia, muscles and the peritoneum. The deepest layer in the abdominal wall AW is the peritoneum PT, which covers many of the abdominal organs, for example the large and small intestines. The peritoneum PT is a serous membrane composed of a layer of mesothelium supported by a thin layer of connective tissue and serves as a conduit for abdominal organ’s blood vessels, lymphatic vessels, and nerves. The area of the abdomen enclosed by the peritoneum PT is called the intraperitoneal space. The tissue and organs within the intraperitoneal space are called "intraperitoneal" (e.g., the stomach and intestines). The tissue and organs in the abdominal cavity that are located behind the intraperitoneal space are called "retroperitoneal" (e.g., the kidneys), and tissue and organs located below the intraperitoneal space are called "subperitoneal" or "infraperitoneal" (e.g., the bladder).

The peritoneum PT is connected to a layer of extraperitoneal fat EF which is connected to a layer or transversalis fascia TF. Connected to the transversalis fascia TF, at the area of the abdominal wall AW at which the section is extracted, is muscle tissue MT separated by layers of deep fascia DF. The deep fascia DF between the layers of muscle is thinner than the transversalis fascia TF and the Scarpa’s fascia SF placed on the outside of the muscle tissue MT. Both the transversalis fascia TF and the Scarpa’s fascia SF are relatively firm membranous sheets. At the area of the abdominal wall AW at which the section is extracted, the muscle tissue MT is composed of the transverse abdominal muscle TM (transversus abdominis), the internal oblique muscle IM (obliquus intemus) and the external oblique muscle EM (obliquus extemus). In other areas of the abdominal wall AW, the muscle tissue could also be composed of the rectus abdominis and the pyramidalis muscle.

The layer outside of the muscle tissue MT, beneath the skin SK of the patient is called subcutaneous tissue ST, also called the hypodermis, hypoderm, subcutis or superficial fascia. The main portion of the subcutaneous tissue ST is made up of Camper’s fascia which consists primarily of loose connective tissue and fat. Generally, the subcutaneous tissue ST contains larger blood vessels and nerves than those found in the skin.

Placing the remote unit 140 at an area of the abdomen is advantageous as the intestines are easily displaced for making sufficient room for the remote unit 140, without the remote unit 140 affecting the patient too much in a sensational or visual way. Also, the placement of the remote unit 140 in the area of the abdomen makes it possible to fixate the remote unit 140 to the muscle tissue MT of the abdomen for creating an attachment keeping the remote unit 140 firmly in place. In the embodiment shown in fig. 26, the first unit 141 ’ of the remote unit 140 is placed on the left side of the patient in between the peritoneum PT and the muscle tissue MT. The second unit 141” is placed in the subcutaneous tissue ST between the muscle tissue MT and the skin SK of the patient. Placing the second unit 141” subcutaneously enables easy access to the second unit 141” for e.g. wireless communication using a wireless transceiver placed in the second unit 141”, wireless charging of an implantable storage unit using a wireless energy receiver placed in the second unit 141”, manual manipulation of for example a push button placed in the second unit 141”, or maintenance or replacement of the second unit 141” via a small incision in the skin SK at the second unit 141”. In the embodiment shown in fig. 26, the electrical leads 135 running inside of protective a cover 136 transports electrical power and/or electrical signals, such as an electrical stimulation signal, an electric damping signal, or a sensor signal, as previously described, from the remote unit 140 to the main portion M of the medical device 100 arranged for instance at the renal artery. The electrical leads 135 may run between the peritoneum PT and the muscle tissue MT vertically until the lead 135 reaches the height of the main portion M of the medical device 100. At this height, the lead 135 may enter the peritoneum PT and travel substantially horizontally to the main portion M of the medical device 100. As such, the lead 135 is placed inside of the intraperitoneal space for as short distance as possible which reduces the risk that implanted, foreign body, elements disturb the intraperitoneal organs, reducing the risk of damage to organs, and reducing the risk that foreign body elements cause ileus.

In the embodiment shown in fig. 26, the connecting portion 142 connects the first and second units 141 ’,141” though three layers of muscle tissue MT, namely tissue of the transverse abdominal muscle TM, the internal oblique muscle IM and the external oblique muscle EM. In alternative embodiments, it is however conceivable that the first unit 141’ is placed in between layers of muscle, such as between tissue of the transverse abdominal muscle TM, the internal oblique muscle IM, or between the internal oblique muscle IM and the external oblique muscle EM. As such, it is conceivable that in alternative embodiments, the connecting portion 142 connects the first and second units 141 ’,141” through two layers of muscle tissue MT, or through one layer of muscle tissue MT.

In alternative embodiments, it is furthermore conceivable that the second portion 141” is placed in between layers of muscle, such as between tissue of external oblique muscle EM and the internal oblique muscle IM, or between the internal oblique muscle IM and the transverse abdominal muscle TM.

In embodiments in which the medical device is hydraulically remotely operable (such as further described with reference to the sensor in fig. 13a-b), flexible wires 135 may be provided, running inside of protective a cover 136 fortransporting linear mechanical force from the remote unit 140 to the main portion M shown in fig. 26 is replaced by conduits (609a-d in fig. 13a-b) for conducting hydraulic fluid for transferring force from a portion of the hydraulic operation device placed in the remote unit 140 to a portion of the operation device placed in the main portion M of the medical device 100 hydraulically.

Figs. 27 and 28 show an embodiment of a remote unit 140 which may be used in combination with any of the hydraulically operable medical devices disclosed herein. The remote unit 140 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 140 comprises a first portion 141’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 141’ having a first cross-sectional area Al in a first plane Pl and comprising a first surface 614 configured to face a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 140 further comprises a second portion 141” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 141” having a second cross-sectional area A2 in a second plane P2 and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be placed 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 and a fourth cross-sectional area A4 in a fourth plane P4 and a third surface 624 configured to engage the 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”.

The connecting portion 142 thus has a portion being sized and shaped to fit through the hole in the tissue portion 610, such portion having the third cross-sectional area A3. Furthermore, the connecting portion 142 may have another portion being sized and shaped to not fit through the hole in the tissue portion 610, such portion having the fourth cross-sectional area A4. Likewise, the second portion 141” may have a portion being sized and shaped to not fit through the hole in the tissue portion 610, such portion having the second cross-sectional area A2. Thus, the connecting portion 142 may cooperate with the second portion 141” to keep the device in place in the hole of the tissue portion 610.

In the embodiment illustrated in fig. 27, the first portion 141’ is configured to detachably connect, i.e. reversibly connect to the connecting portion 142 by a mechanical and/or magnetic mechanism. In the illustrated embodiment, a mechanic mechanism is used, wherein one or several spring-loaded spherical elements 601 lock in place in a groove 603 of the connecting portion 142 when the first portion 141’ is inserted into the connecting portion 142. Other locking mechanisms are envisioned, including corresponding threads and grooves, self-locking elements, and twist and lock fittings.

The remote unit 140 is configured such that, when implanted, the first portion 141’ will be placed closer to an outside of the patient than the second portion 141”. Furthermore, in some implantation procedures the remote unit 140 may be implanted such that space will be available beyond the second portion, i.e. beyond the second side 618 of the tissue portion 610, whereas there may be as much space on the first side 612 of the tissue portion. Furthermore, tissue and/or skin may exert a force on the first portion 141” towards the tissue portion 610 and provide for that the second portion 141” does not travel through the hole in the tissue portion towards the first side 612 of the tissue portion. Thus, it is preferably if the remote unit 140 is primarily configured to prevent the first portion 141” from travelling through the hole in the tissue portion 612 towards the second side 618 of the tissue portion 610.

The first portion 141’ may further comprise one or several connections 605 for transferring energy and/or communication signals to the second portion 141” via the connecting portion 142. The connections 605 in the illustrated embodiment are symmetrically arranged around a circumference of a protrusion 607 of the first portion 141’ and are arranged to engage with a corresponding connection 609 arranged at an inner surface of the connecting portion 142. The protrusion 607 may extend in a central extension Cl of the central portion 142. The second portion 141” may also comprise one or several connections 611, which may be similarly arranged and configured as the connections 605 of the first portion 141’. For example, the one or several connections 611 may engage with the connection 609 of the connecting portion 142 to receive energy and/or communication signals from the first portion 141’. Although the protrusion 607 is illustrated separately in Figs. 27, it is to be understood that the protrusion 607 may be formed as one integral unit with the first portion 141’.

Other arrangements of connections are envisioned, such as asymmetrically arranged connections around the circumference of the protrusion 607. It is also envisioned that one or several connections may be arranged on the first surface 614 of the first portion 141’, wherein the connections are arranged to engage with corresponding connections arranged on the opposing surface 613 of the connecting portion. Such connections on the opposing surface 613 may cover a relatively large area as compared to the connection 609, thus allowing a larger area of contact and a higher rate and/or signal strength of energy and/or communication signal transfer. Furthermore, it is envisioned that a physical connection between the first portion 141’, connecting portion 142 and second portion 141” may be replaced or accompanied by a wireless arrangement, as described further in other parts of the present disclosure.

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 an opposing surface 613 of the connecting portion 142, may be provided with at least one of ribs, barbs, hooks, a friction enhancing surface treatment, and a friction enhancing material, to facilitate the remote unit 140 being held in position by the tissue portion, and/or to facilitate that the different parts of the device are held in mutual position.

The opposing surface 613 of the connecting portion 142 and the first surface 614 of the first portion 141’ may provide, fully or partly, a connection mechanism to detachably connect the first portion 141’ to the connecting portion 142. Such connection mechanisms have been described previously in the presented disclosure and can be arranged on one or both of the opposing surface 613 and the first surface 614 and will not be further described here.

The opposing surface 613 may be provided with a recess configured to house at least part 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 be provided with a recess configured to house at least part 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 enclose at least one protruding element or flange.

In the illustrated embodiment, the first portion 141’ comprises a first energy storage unit 304a and a controller 300a comprising one or several processing units connected to the first energy storage unit 304a. The first energy storage unit 304a may be rechargeable by wireless transfer of energy. In some embodiments, the first energy storage unit 304a may be non-rechargeable. Upon reaching the life-time end of such first energy storage, a replacement first portion comprising a new first energy storage unit may simply be swapped in place for the first portion having the depleted first energy storage unit. The second portion 141” may further comprise a controller 300b comprising one or several processing units.

As will be described in other parts of the present disclosure, the first portion 141’ and the second portion 141” may comprise one or several functional parts, such as receivers, transmitters, transceivers, control units, processing units, sensors, energy storage units, sensors, etc.

The remote unite 140 may be non-inflatable.

As can be seen in figure 28, the first, second, third and fourth planes Pl, P2, P3 and P4, are parallel to each other. Furthermore, in the illustrated embodiment, the third cross-sectional area A3 is smaller than the first, second and fourth cross-sectional areas Al, A2 and A4, such that the first portion 141’, second portion 141” and connecting portion 142 are prevented from travelling through the hole in the tissue portion 610 in a direction perpendicular to the first, second and third planes Pl, P2 and P3. Hereby, the second portion 141” and the connecting portion 142 can be held in position by the tissue portion 610 of the patient also when the first portion 141 ’ is disconnected from the connecting portion 142.

It is to be understood that the illustrated planes Pl, P2, P3 and P4 are merely an example of how such planes may intersect the remote unit 140. Other arrangements of planes are possible, as long as the conditions above are fulfilled, i.e. that the portions have cross-sectional areas, wherein the third cross-sectional area in the third plane P3 is smaller than the first, second and fourth cross- sectional areas, and that the planes Pl, P2, P3 and P4 are parallel to each other.

The connecting portion 142 illustrated in fig. 28 may be defined as a connecting portion 142 comprising a flange 626. The flange 626 thus comprises the fourth cross-sectional area A4 such that the flange 626 is prevented from travelling through the hole in the tissue portion 610 in a direction perpendicular to the first, second and third planes Pl, P2 and P3. The flange 626 may protrude in a direction parallel to the first, second, third and fourth planes Pl, P2, P3 and P4. This direction is perpendicular to a central extension Cl of the connecting portion 142.

The connecting portion 142 is not restricted to flanges, however. Other protruding elements may additionally or alternatively be incorporated into the connecting portion 142. As such, the connecting portion 142 may comprise at least one protruding element comprising the fourth cross- sectional area A4, such that the at least one protruding element is prevented from travelling through the hole in the tissue portion 610, such that the second portion 141” and the connecting portion 142 can be held in position by the tissue portion 610 of the patient also when the first portion 141’ is disconnected 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 Pl, P2, P3 and P4. This direction is perpendicular to a central extension Cl of the connecting portion 142. As such, the at least one protruding element will also comprise the third surface configured to engage the first tissue surface 616 of the first side 612 of the tissue portion 610.

The connecting portion 142 may comprise a hollow portion 628. The hollow portion 628 may provide a passage between the first and second portions 141’, 141”. In particular, the hollow portion 628 may house a conduit for transferring fluid from the first portion 141 ’ to the second portion 141”. The hollow portion 628 may also comprise or house one or several connections or electrical leads for transferring energy and/or communication signals between the first portion 141’ and the second portion 141”.

Some relative dimensions of the remote unit 140 will now be described with reference to figs. 28 and 29a - 29c, however it is to be understood that these dimensions may also apply to other embodiments of the remote unit 140. The at least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane being less than a height Hl of the first portion 141’ in said direction. The height HF may alternatively be less than half of said height Hl of the first portion 141’ in said direction, less than a quarter of said height Hl of the first portion 141’ in said direction, or less than a tenth of said height Hl of the first portion 141 ’ in said direction.

The height Hl of the first portion 141 ’ in a direction perpendicular to the first plane may be less than a height H2 of the second portion 141 ” in said direction, such as less than half of said height H2 of the second portion 141 ”in said direction, less than a quarter of said height H2 of the second portion 141”in said direction, or less than a tenth of said height H2 of the second portion 141” in said direction.

The at least one protruding element 626 may have a diameter DF in the fourth plane being one of less than a diameter DI of the first portion 141’ in the first plane, equal to a diameter DI of the first portion 141 ’ in the first plane, and larger than a diameter D 1 of the first portion 141 ’ in the first plane. Similarly, the cross-sectional area of the at least one protruding element 626 in the fourth plane may be less, equal to, or larger than a cross-sectional area of the first portion in the first plane.

The at least one protruding element 626 may have a height HF in a direction perpendicular to the fourth plane being less than a height HC of the connecting portion 142 in said direction. Here, the height HC of the connecting portion 142 is defined as the height excluding the at least one protruding element, which forms part of the connecting portion 142. The height HF may alternatively be less than half of said height HC of the connecting portion 142 in said direction, less than a quarter of said height HC of the connecting portion 142 in said direction, or less than a tenth of said height HC of connecting portion 142 in said direction.

As shown in Figs. 29a-c the at least one protruding element 626 may 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 a full revolution around the center axis of the connecting portion 142. However, other arrangements are possible, wherein the at least one protruding element 626 constitute a partial circle sector. In the case of a plurality of protruding elements, such plurality of protruding elements may constitute several partial circle sectors.

As shown in Figs. 30a-b, 31a-b and 32a-b, the connecting portion 142 may comprise at least two protruding elements 626, 627. For example, the connecting portion 142 may comprise at least three, four, five, fix, seven, eight, nine, ten protruding elements, and so on. In such embodiments, the at least two protruding elements 626, 627 may together comprise the fourth cross-sectional area, thus providing a necessary cross-sectional area to prevent the first portion and second portion from travelling through the hole in the tissue portion.

The at least two protruding elements 626, 627 may be symmetrically arranged about the central axis of the connecting portion, as shown in Figs. 3 la-b, or asymmetrically arranged about the central axis of the connecting portion, as shown in Figs. 32a-b. In particular, the at least two protruding elements 626, 627 may be asymmetrically arranged so as to be located towards one side of the connecting portion 142, as shown in Figs. 32a-b. The arrangement of protruding element(s) may allow the remote unit 140, and in particular the connecting portion 142, to be placed in areas of the patient where space is limited in one or more directions.

The first portion 141’ may comprise a first energy storage unit for supplying the remote unit 140 with energy.

Although one type or embodiment of the implantable remote unit 140, may fit most patients, it may be necessary to provide a selection of implantable remote units 140 or portions to be assembled into implantable remote units 140. For example, some patients may require different lengths, shapes, sizes, widths or heights depending on individual anatomy. Furthermore, some parts or portions of the implantable remote units 140 may be common among several different types or embodiments of implantable energized medical devices, while other parts or portions may be replaceable or interchangeable. Such parts or portions may include energy storage devices, communication devices, fluid connections, mechanical connections, electrical connections, and so on.

To provide flexibility and increase user friendliness, a kit of parts may be provided. The kit preferably comprises a group of one or more first portions, a group of one or more second portions, and a group of one or more connecting portions, the first portions, second portions and connecting portions being embodied as described throughout the present disclosure. At least one of the groups comprises at least two different types of said respective portions. By the term “type”, it is hereby meant a variety, class or embodiment of said respective portion.

In some embodiments of the kit, the group of one or more first portions, the group of one or more second portions, and the group of one or more connecting portions, comprise separate parts which may be assembled into a complete implantable energized medical device. The implantable energized medical device may thus be said to be modular, in that the first portion, the second portion, and/or the connecting portion may be interchanged for another type of the respective portion.

In some embodiments, the connecting portion form part of the first portion or the second portion.

With reference to Fig. 33, the kit for assembling the implantable energized medical device comprises a group 650 of one or more first portions 141’, in the illustrated example a group of one first portion 141’, a group 652 of one or more connecting portions 142, in the illustrated example a group of three connecting portions 142, and a group 654 of one or more second portions 141 ”, in the illustrated example a group of two second portions 141”. For simplicity, all types and combinations of first portions, second portions and connecting portions will not be illustrated or described in detail.

Accordingly, the group 652 of one or more connecting portions 142 comprise three different types of connecting portions 142. Here, the different types of connecting portions 142 comprise connecting portions 142a, 142b, 142c having different heights. Furthermore, the group 654 of one or more second portions 141” comprise two different types of second portions 141”.

Here, the different types of second portions 141” comprise a second portion 141 ”a being configured to eccentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the second end of the second portion 141”a comprises or is configured for at least one connection for connecting to an implant being located in a caudal direction from a location of the implantable energized medical device in the patient, when the device is assembled. In the illustrated figure, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including the second end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.

Furthermore, the different types of second portions 141” comprise a second portion 141 ”b being configured to eccentrically connect to a connecting portion, having a first end and a second end as described in other parts of the present disclosure, wherein the first end of the second portion 141 ”b comprises or is configured for at least one connection for connecting to an implantable medical device for stretching the stomach wall of the patient, being located in a cranial direction from a location of the implantable energized medical device in the patient, when the device is assembled. In the illustrated figure, the at least one connection is visualized as a lead or wire. However, other embodiments are possible, including the first end comprising a port, connector or other type of connective element for transmission of power, fluid, and/or signals.

Thus, the implantable energized medical device may be modular, and different types of devices can be achieved by selecting and combining a first portion 141’, a connecting portion 142, and a second portion 141”, from each of the groups 652, 654, 656.

In the illustrated example, a first remote unit 140a is achieved by a selection of the first portion 141’, the connecting portion 142a, and the second portion 141”a. Such remote unit 140a may be particularly advantageous in that the connecting portion 142a may be able to extend through a thick layer of tissue to connect the first portion 141’ and the second portion 141 ”a. Another remote unit 140b is achieved by a selection of the first portion 141’, the connecting portion 142c, and the second portion 141 ”b. Such device may be particularly advantageous in that the connecting portion 142c has a smaller footprint than the connecting portion 142a, i.e. occupying less space in the patient. Owing to the modular property of the remote units 140a and 140b, a practician or surgeon may select a suitable connecting portion as needed upon having assessed the anatomy of a patient. Furthermore, since remote units 140a and 140b share a common type of first portions 141’, it will not be necessary for a practician or surgeon to maintain a stock of different first portions (or a stock of complete, assembled devices) merely for the sake of achieving a device having different connections located in the first end or second end of the second portion respectively, as in the case of second portions 141”a, 141 ”b.

The example illustrated in Fig. 33 is merely exemplifying to display the idea of a modular implantable remote unit 140. The group 650 of one or more first portions 141’ may comprise a variety of different features, such as first portions with or without a first energy storage unit, with or without a first wireless energy receiver unit for receiving energy transmitted wirelessly by an external wireless energy transmitter, with or without an internal wireless energy transmitter, and/or other features as described throughout the present disclosure. Other features include different height, width, or length of the first portion. It is to be understood that first portions having one or more such features may be combined with a particular shape or dimensions to achieve a variety of first portions. The same applies to connecting portions and second portions.

With reference to Fig. 34, an embodiment of an implantable remote unit 140, will be described. The remote unit 140 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 140 comprises a first portion 141’ configured to be placed on a first side of the tissue portion 610, the first portion 141’ having a first cross-sectional area in a first plane and comprising a first surface configured to face and/or engage a first tissue surface of the first side of the tissue portion 610. The device 140 further comprises a second portion 141” configured to be placed on a second side of the tissue portion 610, the second side opposing the first side, the second portion 141” 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 610. The remote unit 140 further comprises a connecting portion 142 configured to be placed through a hole in the tissue portion 610 extending between the first and second sides of the tissue portion 610. The connecting portion 142 here 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’ comprises a first wireless energy receiver 308a for receiving energy transmitted wirelessly by an external wireless energy transmitter, and an internal wireless energy transmitter 308a configured to transmit energy wirelessly to the second portion. Furthermore, the second portion here comprises a second wireless energy receiver 308b configured to receive energy transmitted wirelessly by the internal wireless energy transmitter 308a.

Although receivers and transmitters may be discussed and illustrated separately in the present disclosure, it is to be understood that the receivers and/or transmitters may be comprised in a transceiver. Furthermore, the receivers and/or transmitters in the first portion 141’ and second portion 141” respectively may form part of a single receiving or transmitting unit configured for receiving or transmitting energy and/or communication signals, including data. Furthermore, the internal wireless energy transmitter and/or a first wireless communication receiver/transmitter may be a separate unit 308c located in a lower portion of the first portion 141’, referred to as a proximal end of the first portion 141 ’ in other parts of the present disclosure, close to the connecting portion 142 and the second portion 141”. Such placement may provide for that energy and/or communication signals transmitted by the unit 308c will not be attenuated by internal components of the first portion 141’ when being transmitted to the second portion 141”. Such internal components may include a first energy storage unit 304a.

The first portion 141’ here comprises a first energy storage unit 304a connected to the first wireless energy receiver 308a. The second portion comprises a second energy storage unit 304b connected to the second wireless energy receiver 308b. Such an energy storage unit may be a solid- state battery, such as a thionyl-chloride battery.

In some embodiments, the first wireless energy receiver 308a is configured to receive energy transmitted wirelessly by the 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 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 energy transmitted wirelessly by the internal wireless energy transmitter 308a and store the received energy in the second energy storage unit 305b.

The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b. Hereby, charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow. Thus, a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first wireless energy transmitter 308a, c and the second wireless energy receiver 308b.

The first portion may comprise a first controller comprising at least one processing unit 306a. The second portion may comprise a second controller comprising at least one processing unit 306b. At least one of the first and second processing unit 306a, 306b may be connected to a wireless transceiver 308a, b,c for communicating wirelessly with an external device.

The first controller may be connected to a first wireless communication receiver 308a, c in the first portion 141’ for receiving wireless communication from an external device and/or from a wireless communication transmitter 308b in the second portion 141”. Furthermore, the first controller may be connected to a first wireless communication transmitter 308a, c in the first portion 141’ for transmitting wireless communication to a second wireless communication receiver 308b in the second portion 141”. The second controller may be connected to the second wireless communication receiver 308b for receiving wireless communication from the first portion 141’. The second controller may further be connected to a second wireless communication transmitter 308b for transmitting wireless communication to the first portion 141’.

In some embodiments, the first wireless energy receiver 308a comprises a first coil, and the wireless energy transmitter 308a, c comprises a second coil, as shown in Fig. 45.

The device may further comprise at least one sensor (not shown) for providing input to at least one of the first and second controller. 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 comprise a sensor configured to sense a physical parameter of the device 140. The sensor may also be or comprise a sensor configured to sense at least one of a temperature of the remote unit 140, a temperature of an implantable device for treating hypertension, a parameter related to the power consumption of the device, a parameter related to the power consumption of an implantable device for stimulating tissue of the patient or damping such a stimulation signal, a parameter related to a status of at least one of the first and second energy storage unit 304a, 304b, a parameter related to the wireless transfer of energy from a source external to the body of the patient, and a hydraulic pressure. The sensor may also be or comprise a sensor configured to sense a physiological parameter of the patient, such as at least one of a parameter related to the patient swallowing, a local temperature, a systemic temperature, a blood saturation, a blood oxygenation, a blood pressure, a parameter related to an ischemia marker, pH, pressure in the renal artery, or a vascular resistance in a blood vessel. The sensor configured to sense a parameter related to the patient swallowing may comprise at least one of a motility sensor, a sonic sensor, an optical sensor, and a strain sensor. The sensor configured to sense pH may be configured to sense the acidity in the stomach.

The sensor may be configured to sense a 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 charging of an energy storage unit in the device 140. Excessive heating may also damage the device and/or the energy storage unit. Excessive heating may also be an indicator that something is wrong with the device and may be used for triggering an alarm function for alerting the patient or physician. The sensor may also be configured to sense a parameter related to the power consumption of the device 140 or the power consumption of an external implant being powered by the device 140, to avoid excessive power consumption which may drain and/or damage the energy storage unit of the device 140. Excessive power consumption may also be an indicator that something is wrong with the device 140 and may be used for triggering an alarm function for alerting the patient or physician.

With reference to Figs. 35 and 38a-b, an embodiment of an implantable remote unit 140 will be described. The remote unit 140 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 140 comprises a first portion 141 ’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 141’ having a first cross-sectional area A 1 in a first plane Pl and comprising a first surface 614 configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 140 further comprises a second portion 141” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 141” having a second cross- sectional area A2 in a second plane P2 and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be placed 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. The connecting portion 142 is configured to connect the first portion 141’ to the second portion 141”. In the illustrated embodiment, a connecting interface 630 between the connecting portion 142 and the second portion 141” is eccentric with respect to the second portion 141”.

The first portion 141’ has an elongated shape in the illustrated embodiment of Fig. 35. Similarly, the second portion 141” has an elongated shape. However, the first portion 141’ and/or second portion 141” may assume other shapes, such as a flat disk e.g. having a width and length being larger than the height, a sphere, an ellipsoid, or any other polyhedral or irregular shape, some of these being exemplified in Figs. 35-37.

As illustrated in figs. 38a-b, the connecting interface 630 between the connecting portion 142 and the second portion 141” may be eccentric, with respect to the second portion 141” in a first direction 631, but not in a second direction 633 being perpendicular to the first direction. The first direction 631 is here parallel to the line A-A, to the second plane P2, and to a length of the second portion 141”. The second direction 633 is here parallel to the line B-B, to the second plane P2, and to a width of the second portion 141 ” . It is also possible that the connecting interface between the connecting portion 142 and the second portion 141 ” is eccentric, with respect to the second portion 141”, in the first direction 631 as well as in the second direction 633 being perpendicular to the first direction 631.

Similarly, a connecting interface between the connecting portion 142 and the first portion 141’ may be eccentric with respect to the first portion 141 ’ in the first direction 631, and/or in the second direction 633.

The first portion 141’, connecting portion 142 and second portion 141” may structurally form one integral unit. It is however also possible that the first portion 141 ’ and the connecting portion 142 structurally form one integral unit, while the second portion 141” form a separate unit, or, that the second portion 141” and the connecting portion 142 structurally form one integral unit, while the first portion 141’ form a separate unit.

Additionally, or alternatively, the second portion 141” may comprise a removable and/or interchangeable portion 639. In some embodiments, the removable portion 639 may form part of a distal region which will be further described in other parts of the present disclosure. A removable portion may also form part of a proximal region. Thus, the second portion 141” may comprise at least two removable portions, each being arranged at a respective end of the second portion 141”. The removable portion 639 may house, hold or comprise one or several functional parts of the remote unit 140, such as gears, motors, connections, reservoirs, and the like as described in other parts of the present disclosure. An embodiment having such removable portion 639 will be able to be modified as necessary to circumstances of a particular patient.

In the case of the first portion 141’, connecting portion 142 and second portion 141” structurally forming one integral unit, the eccentric connecting interface between the connecting portion 142 and the second portion 141”, with respect to the second portion 141”, will provide for that the remote unit 140 will be able to be inserted into the hole in the tissue portion. The remote unit 140 may for example be inserted into the hole at an angle, similar to how a foot is inserted into a shoe, to allow most or all of the second portion 141 ” to pass through the hole, before it is angled, rotated, and/or pivoted to allow any remaining portion of the second portion 141” to pass through the hole and allow the remote unit 140 to assume its intended position.

As illustrated in figs. 35-37, the first portion 141’ may assume a variety of shapes, such as an oblong shape, a flat disk shape, a spherical shape, or any other polyhedral or irregular shape. Similarly, the second portion 141” may assume a variety of shapes, such as an oblong shape, a flat disk shape, a spherical shape, or any other polyhedral or irregular shape. The proposed shapes of the first and second portions 141’, 141” may be mixed and combined to form embodiments not exemplified in the illustrated embodiments. For example, one or both of the first and second portions 141’, 141” may have a flat oblong shape. In this context, the term “flat” is related to the height of the first or second portion 141’, 141”, i.e. in a direction parallel to a central extension Cl of the connecting portion 142. The term “oblong” is related to a length of the first or second portion 141’, 141”. A definition of such length is further discussed in other parts of the present disclosure.

With reference to Figs. 38a-b, the second portion 141” has a first end 632 and a second end 634 opposing the first end 632. The length of the second portion 141” is defined as the length between the first end 632 and the second end 634. The length of the second portion 141” is furthermore extending in a direction being different to the central extension C 1 of the connecting portion 142. The first end 632 and second end 634 are separated in a direction parallel to the second plane P2. Similarly, the first portion 141’ has a length between a first and a second end, the length extending in a direction being different to the central extension Cl of the connecting portion 142.

The second portion 141” may be curved along its length. For example, one or both ends of the second portion 141” may point in a direction being substantially different from the second plane P2, i.e. curving away from or towards the tissue portion when implanted. In some embodiments, the second portion 141” curves within the second plane P2, exclusively or in combination with curving in other planes. The second portion 141” may also be curved in more than one direction, i.e. along its length and along its width, the width extending in a direction perpendicular to the length.

The first and second ends 632, 634 of the second portion 141” may comprise an elliptical point respectively. For example, the first and second ends 632, 634 may comprise a hemispherical end cap respectively. It is to be understood that also the first and second ends of the first portion 141’ may have such features.

The second portion 141” may have at least one circular cross-section along the length between the first end 632 and second end 634, as illustrated in fig. 35. It is however possible for the second portion 141” to have at least one oval cross-section or at least one elliptical cross-section along the length between the first end 632 and the second end 634. Such cross-sectional shapes may also exist between ends in a width direction of the second portion 141”. Similarly, such cross- sectional shapes may also exist between ends in a length and/or width direction in the first portion 141’.

In the following paragraphs, some features and properties of the second portion 141” will be described. It is however to be understood that these features and properties may also apply to the first portion 141’.

The second portion 141” has a proximal region 636, an intermediate region 638, and a distal region 640. The proximal region 636 extends from the first end 632 to an interface between the connecting portion 142 and the second portion 141”, the intermediate region 638 is defined by the connecting interface 630 between the connecting portion 142 and the second portion 141”, and the distal region 640 extends from the connecting interface 630 between the connecting portion 142 and the second portion 141’ ’ to the second end 634. The proximal region 636 is shorter than the distal region 640 with respect to the length of the second portion, i.e. with respect to the length direction 631. Thus, a heel (the proximal region) and a toe (the distal region) is present in the second portion 141”.

The second surface 620, configured to engage with the second tissue surface 622 of the second side 618 of the tissue portion 610, is part of the proximal region 636 and the distal region 640. If a length of the second portion 141’ ’ is defined as x, and the width of the second portion 141” is defined as y along respective length and width directions 631, 633 being perpendicular to each other and substantially parallel to the second plane P2, the connecting interface between the connecting portion 142 and the second portion 141” is contained within a region extending from x>0 to x<x/2 and/or y>0 to J’^<J’/2. x and y and 0 being respective end points of the second portion 141” along said length and width directions. In other words, the connecting interface between the connecting portion 142 and the second portion 141” is eccentric in at least one direction with respect to the second portion 141 ”, such that a heel and a toe is formed in the second portion 141”.

The first surface 614 configured to face and/or engage the first tissue surface 616 of the first side 612 of the tissue portion 610 may be substantially flat. In other words, the first portion 141’ may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the first portion 141’, facing away from the tissue portion 610, may be substantially flat. Similarly, the second surface 620 configured to engage the second tissue surface 622 of the second side 618 of the tissue portion 610 may be substantially flat. In other words, the second portion 141” may comprise a substantially flat side facing towards the tissue portion 610. Furthermore, an opposing surface of the second portion 141”, facing away from the tissue portion 610, may be substantially flat.

The second portion 141” may be tapered from the first end 632 to the second end 634, thus giving the second portion 141” different heights and/or widths along the length of the second portion 141”. The second portion may also be tapered from each of the first end 632 and second end 634 towards the intermediate region 638 of the second portion 141”.

Some dimensions of the first portion 141’, the second portion 141” and the connecting portion 142 will now be disclosed. Any of the following disclosures of numerical intervals may include or exclude the end points of said intervals.

The first portion 141’ may have a maximum dimension being in the range of 10 to 60 mm, such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the range of 10 to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such as in the range of 15 to 30 mm, such as in the range of 15 to 25 mm. By the term “maximum dimension” it is hereby meant the largest dimension in any direction. The first portion 141 ’ may have a diameter being in the range of 10 to 60 mm, such as in the range of 10 to 40 mm such as in the range of 10 to 30 mm, such as in the range of 10 to 25 mm, such as in the range of 15 to 40 mm, such as in the range of 15 to 35 mm, such as in the range of 15 to 30 mm, such as in the range of 15 to 25 mm.

The connecting portion 142 may have a maximum dimension in the third plane P3 in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, such as in the range of 2 to 10 mm, such as in the range of 5 to 10 mm, such as in the range of 8 to 20 mm, such as in the range of 8 to 15 mm, such as in the range of 8 to 10 mm.

The second portion 141 ” may have a maximum dimension being in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, such as in the range of 30 to 60 mm, such as in the range of 30 to 40 mm, such as in the range of 35 to 90 mm, such as in the range of 35 to 70 mm, such as in the range of 35 to 60 mm, such as in the range of 35 to 40 mm.

The first portion has a first height Hl, and the second portion has a second height H2, both heights being in a direction perpendicular to the first and second planes Pl, P2. The first height may be smaller than the second height. However, in the embodiments illustrated in Figs. 38A-38B, the first height Hl is substantially equal to the second height H2. Other height ratios are possible, for example the first height Hl may be less than 2/3 of the second height H2, such as less than 1/2 of the second height H2, such as less than 1/3 of the second height H2, such as less than 1/4 of the second height H2, such as less than 1/5 of the second height H2, such as less than 1/10 of the second height H2.

As illustrated in Figs. 38a-b, the proximal region 636 has a length 642 being shorter than a length 646 of the distal region 640. The intermediate region 638 has a length 644, and a width 648. In some embodiments, the length 644 of the intermediate region 638 is longer than the width 648. In other words, the connecting interface between the connecting portion 142 and the second portion 141” may be elongated, having a longer dimension (in the exemplified case, the length) and a shorter dimension (in the exemplified case, the width). It is also possible that the length 644 of the intermediate region 638 is shorter than the width 648 of the intermediate region 638.

The length 646 of the distal region 640 is preferably longer than the length 644 of the intermediate region 638, however, an equally long distal region 640 and intermediate region 638, or a shorter distal region 640 than the intermediate region 638, is also possible. The length 642 of the proximal region 636 may be shorter than, equal to, or longer than the length 644 of the intermediate region 638.

The length 644 of the intermediate region 638 is preferably less than half of the length of the second portion 141”, i.e. less than half of the combined length of the proximal region 636, the intermediate region 638, and the distal region 630. In some embodiments, the length 644 of the intermediate region 638 is less than a third of the length of the second portion 141”, such as less than a fourth, less than a fifth, or less than a tenth of the length of the second portion 141”. The connecting portion may have one of an oval cross-section, an elongated cross-section, and a circular cross-section, in a plane parallel to the third plane P3. In particular, the connecting portion may have several different cross-sectional shapes along its length in the central extension Cl.

In some embodiments the distal region 640 is configured to be directed downwards in a standing patient, i.e. in a caudal direction when the remote unit 140 is implanted. As illustrated in Figs. 39a-d, different orientations of the second portion 141” relative the first portion 141’ are possible. In some embodiments, a connection between either the first portion 141’ and the connecting portion 142, or between the second portion 141” and the connecting portion 142, may allow for a plurality of different connecting orientations. For example, a connection mechanism between the first portion 141’ and the connecting portion 142 (or between the second portion 141” and the connecting portion 142) may possess a 90 degree rotational symmetry to allow the second portion 141 ’ to be set in four different positions with respect to the first portion 141, each differing from the other by 90 degrees. Other degrees of rotational symmetry are of course possible, such as 30 degrees, 45 degrees, 60 degrees, 120 degrees, 180 degrees and so on. In other embodiments there are no connective mechanism between any of the first portion 141’, the connecting portion 142, and the second portion 141” (i.e. the portions are made as one integral unit), and in such cases different variants of the device 140 can be achieved during manufacturing. In other embodiments, the connective mechanism between the first portion 141’ and the connecting portion 142 (or between the second portion 141” and the connecting portion 142) is non-reversible, i.e. the first portion 141’ and the second portion 141” may initially be handled as separate parts, but the orientation of the second portion 141” relative the first portion 141’ cannot be changed once it has been selected and the parts have been connected via the connecting portion 142.

The different orientations of the second portion 141” relative the first portion 141’ may be defined as the length direction of the second portion 141” having a relation or angle with respect to a length direction of the first portion 141’. Such angle may be 15 degrees, 30, 45, 60, 75 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270, 285, 300, 315, 330, 345 or 360 degrees. In particular, the angle between the first portion 141’ and the second portion 141” may be defined as an angle in the planes Pl and P2, or as an angle in a plane parallel to the tissue portion 610, when the remote unit 140 is implanted. In the embodiment illustrated in Figs. 39a-d, the length direction of the second portion 141” is angled by 0, 90, 180, and 270 degrees with respect to the length direction of the first portion 141’.

The second end 634 of the second portion 141” may comprise one or several connections for connecting to an implant being located in a caudal direction from a location of the implantable energized medical device in the patient. Hereby, when the remote unit 140 is implanted in a patient, preferably with the distal region 640 and second end 634 pointing downwards in a standing patient, the connections will be closer to the implant as the second end 634 will be pointing in the caudal direction whereas the first end 632 will be pointing in the cranial direction. It is also possible that the second end 634 of the second portion 141” is configured for connecting to an implant, i.e. the second end 634 may comprise a port, connector or other type of connective element for transmission of power, fluid, and/or signals.

Likewise, the first end 632 of the second portion 141” may comprise one or several connections for connecting to an implant being located in a cranial direction from a location of the implantable energized medical device in the patient. Hereby, when the remote unit 140 is implanted in a patient, preferably with the distal region 640 and second end 634 pointing downwards in a standing patient, the connections will be closer to the implant as the first end 632 will be pointing in the cranial direction whereas the second end 634 will be pointing in the caudal direction. It is also possible that the first end 632 of the second portion 141’ ’ is configured for connecting to an implant, i.e. the first end 632 may comprise a port, connector or other type of connective element for transmission of power, fluid, and/or signals.

With reference to figs. 40 and 41, an embodiment of an implantable remote unit 140 will be described. The remote unite 140 is configured to be held in position by atissue portion 610 of a patient. The remote unit 140 comprises a first portion 141’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 141’ having a first cross-sectional area in a first plane and comprising a first surface 614 configured to face and/or engage a first tissue surface 616 of the first side 612 of the tissue portion 610. The remote unit 140 further comprises a second portion 141” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 141” having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface 622 of the second side 618 of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be placed 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 in a third plane. The connecting portion 142 is configured to connect the first portion 141’ to the second portion 141”.

With reference to Fig. 42, the first cross-sectional area has a first cross-sectional distance CD la and a second cross-sectional distance CD2a, the first and second cross-sectional distances CD la, CD2a being perpendicular to each other and the first cross-sectional distance CD la being longer than the second cross-sectional distance CD2a. Furthermore, the second cross-sectional area has a first cross-sectional distance CD lb and a second cross-sectional distance CD2b, the first and second cross-sectional distances CD2a, CD2b being perpendicular to each other and the first cross- sectional distance CD lb being longer than the second cross-sectional distance CD2b. The first cross-sectional distance CD la of the first cross-sectional area and the first cross-sectional distance CD lb of the second cross-sectional area are rotationally displaced in relation to each other with an angle exceeding 45° to facilitate insertion of the second portion 141” through the hole in the tissue portion. In the embodiment illustrated in Fig. 42, the rotational displacement is 90°.

The rotational displacement of the first portion 141’ and the second portion 141” forms a cross-like structure, being particularly advantageous in that insertion through the hole in the tissue portion 610 may be facilitated, and once positioned in the hole in the tissue portion 610 a secure position may be achieved. In particular, if the remote unit 140 is positioned such that the second portion 141” has its first cross-sectional distance CD lb extending along a length extension of the hole 611 in the tissue portion 610, insertion of the second potion 141” through the hole 611 may be facilitated. Furthermore, if the first portion 141 ’ is then displaced in relation to the second portion 141” such that the first cross-sectional distance CD la of the first portion 141’ is displaced in relation to a length extension of the hole 611, the first portion 141’ may be prevented from travelling through the hole 611 in the tissue portion. In these cases, it is particularly advantageous if the hole 611 in the tissue portion is oblong, ellipsoidal, or at least has one dimension in one direction being longer than a dimension in another direction. Such oblong holes in a tissue portion may be formed for example in tissue having a fiber direction, where the longest dimension of the hole may be aligned with the fiber direction.

In the embodiment illustrated in Fig. 40, the first surface 614 of the first portion 141 ’ is flat, thus providing a larger contact surface to the first tissue surface 616 and consequently less pressure on the tissue portion. A more stable position may also be achieved by the flat surface. Also the second surface 620 of the second portion 141” may be flat. However, other shapes, such as those described in other parts of the present disclosure, are possible.

As shown in Fig. 42, the connecting portion 142 may have an elongated cross-section in the third plane. It may be particularly advantageous if the connecting portion 142 has a longer length 644 than width 648, said length 644 extending in the same direction as a length direction of the second portion 141”, i.e. in the same direction as an elongation of the second portion 141”. Hereby, the elongation of the connecting portion 142 may run in the same direction as an elongation of the hole in the tissue portion.

With reference to Fig. 43, the rotational displacement of first cross-sectional distance of the first cross-sectional area and the first cross-sectional distance of the second cross-sectional area is shown, here at an angle about 45°. Accordingly, there is a rotational displacement, in the first, second and third planes, between a length direction 633 of the first portion 141’ and a length direction 631 of the second portion 141”. Other angles of rotational displacement are possible, such as 60°, 75, 90°, 105°, 120°, 135°, etc.

One and the same remote unit 140 may be capable of assuming several different arrangements with regards to rotational displacement of the first portion 141’ and the second portion 141 ” . In particular, this is possible when the first portion 141’ and/or the second portion 141” is configured to detachably connect to the interconnecting portion 142. For example, a connection mechanism between the first portion 141’ and the connecting portion 142, or between the second portion 141” and the connecting portion 142, may possess a rotational symmetry to allow the first portion 141’ to be set in different positions in relation to the connecting portion 142 and in extension also in relation to the second portion 141”. Likewise, such rotational symmetry may allow the second portion 142” to be set in different positions in relation to the connecting portion 142 and in extension also in relation to the first portion 141’.

With reference to Figs. 44a-c, a procedure of insertion of the remote unit 140 in a tissue portion 610 will be described. The remote unit 140 may be oriented such that a length direction 631 of the second portion 141” points downwards into the hole 611. Preferably, the second portion 141” is positioned such that it is inserted close to an edge of the hole 611. The second portion 141” may then be inserted partially through the hole 611, until the point where the first portion 141’ abuts the first tissue surface 616. Here, a 90° rotational displacement between the first portion 141’ and the second portion 141”, as described above, will allow a relatively large portion of the second portion 141” to be inserted before the first portion 141’ abuts the first tissue surface 616. Subsequently, the remote unit 140 may be pivoted to slide or insert the remaining portion of the second portion 141” through the hole 611. While inserting the remaining portion of the second portion 141”, the tissue may naturally flex and move to give way for the second portion 141”. Upon having fully inserted the second portion 141” through the hole 611, such that the second portion 141” is completely located on the other side of the tissue portion 610, the tissue may naturally flex back.

With reference to fig. 45, an embodiment of an implantable remote unit 140, which may be referred to as a remote unit in other parts of the present disclosure, will be described. The remote unit 140 is configured to be held in position by a tissue portion 610 of a patient. The remote unit 140 comprises a first portion 141’ configured to be placed on a first side 612 of the tissue portion 610, the first portion 141’ having a first cross-sectional area in a first plane and comprising a first surface 614 configured to face and/or engage a first tissue surface of the first side 612 of the tissue portion 610. The remote unit 140 further comprises a second portion 141” configured to be placed on a second side 618 of the tissue portion 610, the second side 618 opposing the first side 612, the second portion 141” having a second cross-sectional area in a second plane and comprising a second surface 620 configured to engage a second tissue surface of the second side 618 of the tissue portion 610. The remote unit 140 further comprises a connecting portion 142 configured to be placed 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 in a third plane. The connecting portion 142 is configured to connect the first portion 141 ’ to the second portion 141”.

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 being configured for at least one of: receiving energy transmited wirelessly, transmiting energy wirelessly, receiving wireless communication, and transmiting wireless communication. In the illustrated embodiment, the first portion 141’ comprises a first coil 658 and a second coil 660, and the second portion 141” comprises a third coil 662. The coils are embedded in a ceramic material 664

As discussed in other part of the present disclosure, the first portion 141’ may comprise a first wireless energy receiver configured to receive energy transmited wirelessly from an external wireless energy transmiter, and further the first portion 141’ may comprise a first wireless communication receiver. The first wireless energy receiver and the first wireless communication receiver may comprise the first coil. Accordingly, the first coil may be configured to receive energy wirelessly, and/or to receive communication wirelessly.

By the expression “the receiver/transmiter comprising the coil” it is to be understood that said coil may form part of the receiver/transmiter.

The first portion 141’ comprises a distal end 665 and a proximal end 666, here defined with respect to the connecting portion 142. In particular, the proximal end 665 is arranged closer to the connecting portion 142 and closer to the second portion 141” when the remote unit 140 is assembled. In the illustrated embodiment, the first coil 658 is arranged at the distal end 665.

The first portion 141’ may comprise an internal wireless energy transmiter, and further a first wireless communication transmiter. In some embodiments, the internal wireless energy transmiter and/or the first wireless communication transmiter comprises the first coil 658. However, in some embodiments the internal wireless energy transmiter and/or the first wireless communication transmiter comprises the second coil 660. The second coil 660 is here arranged at the proximal end 665 of the first portion 141’. Such placement of the second coil 660 may provide for that energy and/or communication signals transmited by the second coil 660 will not be atenuated by internal components of the first portion 141’ when being transmited to the second portion 141”.

In some embodiments, the first wireless energy receiver and the internal wireless energy transmiter comprises a single coil embedded in a ceramic material. Accordingly, a single coil may be configured for receiving energy wirelessly and for transmiting energy wirelessly. Similarly, the first wireless communication receiver and the first wireless communication transmiter may comprise a single coil embedded in a ceramic material. Even further, in some embodiments a single coil may be configured for receiving and transmiting energy wirelessly, and for receiving and transmiting communication signals wirelessly.

The coils discussed herein are preferably arranged in a plane extending substantially parallel to the tissue portion 610.

The second portion 141” may comprise a second wireless energy receiver, and/or a second wireless communication receiver. In some embodiments, the third coil 662 in the second portion 141” comprises the second wireless energy receiver and/or the second wireless communication receiver.

The second portion 141” comprises a distal end 668 and a proximal end 670, here defined with respect to the connecting portion 142. In particular, the proximal end 668 is arranged closer to the connecting portion 142 and closer to the first portion 141’ when the remote unit 140 is assembled. In the illustrated embodiment, the third coil 662 is arranged at the proximal end 668 of the second portion 141”. Such placement of the third coil 662 may provide for that energy and/or communication signals received by the third coil 662 will not be attenuated by internal components of the second portion 141” when being received from the first portion 141’.

The first portion 141’ may comprise a first controller 300a connected to the first coil 658, second coil 660, and/or third coil 662. The second portion 141” may comprise a second controller 300b connected to the first coil, 658, second coil 660, and/or third coil 662.

In the illustrated embodiment , the first portion 141’ comprises a first energy storage unit 304a connected to the first wireless energy receiver 308a, i.e. the first coil 658. The second portion comprises a second energy storage unit 304b connected to the second wireless energy receiver 308b, i.e. the third coil 662. Such an energy storage unit may be a solid-state battery, such as a thionyl-chloride battery.

In some embodiments, the first coil 658 is configured to receive energy transmitted wirelessly by the external wireless energy transmitter and store the received energy in the first energy storage unit 304a. Furthermore, the first coil 658 and/or the second coil 660 may be configured to wirelessly transmit energy stored in the first energy storage unit 304a to the third coil 662, and the third coil 662 may be configured to receive energy transmitted wirelessly by the first coil 658 and/or the second coil 660 and store the received energy in the second energy storage unit 305b.

The first energy storage unit 304a may be configured to store less energy than the second energy storage unit 304b, and/or configured to be charged faster than the second energy storage unit 304b. Hereby, charging of the first energy storage unit 304a may be relatively quick, whereas transfer of energy from the first energy storage unit 304a to the second energy storage unit 304b may be relatively slow. Thus, a user can quickly charge the first energy storage unit 304a, and will not during such charging be restricted for a long period of time by being connected to an external wireless energy transmitter, e.g. at a particular location. After having charged the first energy storage unit 304a, the user may move freely while energy slowly transfers from the first energy storage unit 304a to the second energy storage unit 304b, via the first and/or second coil and the third coil.

In the following, numbered aspect groups 378SE, 379SE1, 379SE2, 380SE, 381SE1, 381SE2, 382SE1, 382SE2, 382SE3, 404SE, 405SE, 406SE, 407SE, 408SE and 409SE of the present inventive concept are provided. The different aspects are numbered individually within the groups and the references to other aspects relate primarily to aspects within the same group. The scope of protection is however defined by the appended claims.

Aspect group 378SE: Subcutaneous_Control_Pop-Rivet2_Outside-Peritoneum

1. A method of implanting a powered medical device, the method comprising: placing a first unit of a remote unit between a peritoneum and a layer of muscular tissue of the abdominal wall, placing a second unit of the remote unit between the skin of the patient and a layer of muscular tissue of the abdominal wall, wherein the first and second units are configured to be connected by a connecting portion extending through at least one layer of muscular tissue of the abdominal wall, placing a body engaging portion of the powered medical device in connection with a tissue or an organ of the patient which is to be affected by the powered medical device, and placing a transferring member, configured to transfer at least one of energy and force from the first unit to the body engaging portion, at least partially between a peritoneum and a layer of muscular tissue of the abdominal wall, such that at least 1/3 of the length of the transferring member is placed on the outside of the peritoneum.

2. The method according to any aspect 1, wherein the transferring member is configured to transfer electrical energy force from the first unit to the body engaging portion.

3. The method according to aspect 1 or 2, wherein the transferring member is configured to transfer data between the first unit and the body engaging portion.

4. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least 1/2 of the length of the transferring member is placed on the outside of the peritoneum of the patient.

5. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least 2/3 of the length of the transferring member is placed on the outside of the peritoneum of the patient.

6. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member entirely outside of the peritoneum of the patient.

7. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the first unit to an area between the rib cage and the peritoneum of the patient, outside of the peritoneum.

8. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the first unit to an area between the stomach and the thoracic diaphragm of the patient. 9. The method according to any one of the preceding aspects, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the first unit to the retroperitoneal space.

10. The method according to aspect 9, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the first unit to an area of the kidneys.

11. The method according to aspect 10, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the first unit to the renal arteries.

12. The method according to any one of aspects 1 - 5, wherein the step of placing the transferring member comprises placing the transferring member such that it extends from the first unit to the subperitoneal space, outside of the peritoneum.

13. The method according to any one of the preceding aspects, wherein the step of placing the first unit of the remote unit between the peritoneum and the layer of muscular tissue of the abdominal wall comprises placing the first unit between a first and second layer of muscular tissue of the abdominal wall.

14. The method according to any one of the preceding aspects, wherein the step of placing the first unit comprises placing a first unit comprising an energy storage unit.

15. The method according to any one of the preceding aspects, wherein the step of placing the first unit comprises placing a first unit comprising a receiver for receiving at least one of: energy and communication, wirelessly.

16. The method according to any one of the preceding aspects, wherein the step of placing the second unit comprises placing a second unit comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.

17. The method according to any one of the preceding aspects, wherein the step of placing the first unit comprises placing a first unit comprising a controller involved in the control of the powered medical device.

18. The method according to any one of the preceding aspects, wherein the first unit is elongated and has a length axis extending substantially in the direction of the elongation of the first unit, and wherein the step of placing the first unit comprises placing the first unit such that the length axis is substantially parallel with the cranial -caudal axis of the patient.

19. The method according to any one of aspects 1 - 17, wherein the first unit is elongated and has a length axis extending substantially in the direction of the elongation of the first unit, and wherein the step of placing the first unit comprises placing the first unit such that the length axis is substantially perpendicular with the cranial -caudal axis of the patient.

20. The method according to any one of the preceding aspects, wherein the first unit is elongated and has a length axis extending substantially in the direction of the elongation of the first unit, and wherein the step of placing the first unit comprises entering a hole in a layer of muscular tissue of the stomach wall in the direction of the length axis of the first portion and pivoting or angling the first portion after the hole has been entered.

21. The method according to any one of the preceding aspects, wherein the step of placing the second unit of the remote unit between the skin of the patient and a layer of muscular tissue of the abdominal wall comprises placing the second unit in the subcutaneous tissue.

22. The method according to any one of aspects 1 - 20, wherein the step of placing the second unit of the remote unit between the skin of the patient and a layer of muscular tissue of the abdominal wall comprises placing the second unit between a first and second layer of muscular tissue of the abdominal wall.

23. The method according to any one of the preceding aspects, wherein the step of placing the second unit comprises placing a second unit comprising an energy storage unit.

24. The method according to any one of the preceding aspects, wherein the step of placing the second unit comprises placing a second unit comprising a receiver for receiving at least one of: energy and communication, wirelessly.

25. The method according to any one of the preceding aspects, wherein the step of placing the second unit comprises placing a second unit comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.

26. The method according to any one of the preceding aspects, wherein the step of placing the second unit comprises placing a second unit comprising a controller involved in the control of the powered medical device.

27. The method according to any one of the preceding aspects, wherein the second unit is elongated and has a length axis extending substantially in the direction of the elongation of the second unit, and wherein the step of placing the second unit comprises placing the second unit such that the length axis is substantially parallel with the cranial-caudal axis of the patient.

28. The method according to any one of the preceding aspects, wherein the second unit is elongated and has a length axis extending substantially in the direction of the elongation of the second unit, and wherein the step of placing the second unit comprises placing the second unit such that the length axis is substantially perpendicular with the cranial -caudal axis of the patient.

29. The method according to any one of the preceding aspects, wherein the first unit is elongated and has a first unit length axis extending substantially in the direction of the elongation of the first unit second unit, and the second unit is elongated and has a second unit length axis extending substantially in the direction of the elongation of the second unit, and wherein the step of placing the first and second units comprises placing the first and second units such that the first unit length axis and the second unit length axis are places at an angle in relation to each other exceeding 30°. 30. The method according to aspect 29, wherein the step of placing the first and second units comprises placing the first and second units such that the first unit length axis and the second unit length axis are places at an angle in relation to each other exceeding 45°.

31. The method according to any one of the preceding aspects, further comprising the step of placing the connecting portion through at least one layer of muscular tissue of the abdominal wall.

32. The method according to any one of the preceding aspects, wherein the first unit, the second unit and the connecting portion are portions of a single unit.

33. The method according to any one of aspects 1 - 31, further comprising the step of connecting the first portion to the connecting portion, in situ.

34. The method according to any one of aspects 1 - 31, further comprising the step of connecting the second portion to the connecting portion, in situ.

35. The method according to any one of the preceding aspects, further comprising the step of connecting the transferring member to the first unit.

36. The method according to any one of the preceding aspects, further comprising the step of connecting the transferring member to the body engaging portion.

37. The implantable device according to any of the preceding aspects, wherein the body engaging portion comprises an implantable constriction device.

38. The implantable device according to aspect 37, wherein the implantable constriction device comprises an implantable constriction device for constricting a blood vessel of the patient.

39. The implantable device according to aspect 38, wherein the implantable constriction device for constricting a blood vessel of the patient is configured to constrict the blood flow in the renal artery to affect the patients systemic blood pressure.

40. The implantable device according to any one of the preceding aspects, wherein the body engaging element comprises an element for electrically stimulating a tissue portion of a patient.

Aspect group 379SE1: Hypertension_Local_Treatment2

1. A system for treating a patient with hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of a smooth muscle tissue of the renal artery; an implantable source of energy configured to energize the electrode arrangement; and a control unit operably connected to the stimulation device; wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes a controlled vasodilation of the renal artery.

2. The system according to aspect 1, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

3. The system according to aspect 1 or 2, wherein the electrode arrangement is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

4. The system according to aspect 3, wherein the support structure comprises a cuff portion configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

5. The system according to aspect 4, wherein the electrode arrangement is arranged on an inner surface of the cuff.

6. The system according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve.

7. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

8. The system according to aspect 7, wherein the electrical stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

9. The system according to aspect 7 or 8, wherein the electrical stimulation signal comprises a pulse width of 0.01-1 ms.

10. The system according to any of aspects 7 to 9, wherein the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.

11. The system according to any of the preceding aspects, further comprising a signal damping device configured to be arranged at the parasympathetic nerve, at a position between the stimulation device and the spinal cord. 12. The system according to aspect 11, wherein the signal damping device comprises an electrode arrangement configured to deliver an electric damping signal to the parasympathetic nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal generated by the stimulation device.

13. The system according to aspect 12, wherein the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal.

14. The system according to any of the preceding aspects, wherein the control unit is configured to be communicatively connected to a wireless remote control.

15. The system according to aspect 14, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

16. The system according to any of the preceding aspects, further comprising a blood pressure sensor configured to generate a signal indicating a blood pressure of the patient.

17. The system according to aspect 16, wherein the blood pressure sensor is configured to determine a local blood pressure in the renal artery.

18. The system according to aspect 16 or 17, wherein the blood pressure sensor is configured to determine a systemic blood pressure.

19. The system according to any of aspects 16-17, wherein the control unit is configured to receive the signal generated by the blood pressure sensor.

20. The system according to aspect 19, wherein the control unit is configured to control the operation of the stimulation device based on the received signal.

21. The system according to any of the preceding aspects, wherein the source of energy is configured to be implanted subcutaneously.

22. The system according to any of the preceding aspects, wherein the source of energy comprises at least one of a primary cell and a secondary cell.

23. The system according to any of the preceding aspects, wherein the control unit is configured to indicate a functional status of the source of energy.

24. The system according to aspect 23, wherein the functional status indicates a charge level of the source of energy.

25. The system according to any of aspects 1-22, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the wall portion and the blood flowing through the renal artery.

26. The system according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the implantable source of energy, and the control unit. 27. The system according to aspect 26, wherein the coating comprises at least one layer of a biomaterial.

28. The system according to aspect 27, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

29. The system according to aspect 27 or 28, wherein the biomaterial is fibrin-based.

30. The system according to any of aspects 27-29, further comprising a second coating (760b) arranged on the first coating.

31. The system according to aspect 30, wherein the second coating is a different biomaterial than said first coating.

32. The system according to aspect 31, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.

33. The system according to any one of aspects 27-32, wherein the coating comprises a drug encapsulated in a porous material.

34. The system according to any one of aspects 27-33, wherein the surface comprises a metal.

35. The system according to aspect 34, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.

36. The system according to any of aspects 27-35, wherein the surface comprises a micropattem.

37. The system according to aspect 36, wherein the micropattem is etched into the surface prior to insertion into the body.

38. The system according to aspect 36 or 37, further comprising a layer of a biomaterial coated on the micropattem.

39. A communication system for enabling communication between a display device and a system (100) according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the implantable device and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the implantable device, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the implantable device.

40. A system for treating a patient with hypertension according to any of the preceding aspects, wherein the stimulation device is adapted to stimulate the parasympathetic system, thereby causing vasodilation and lowering a blood pressure of the patient, wherein the stimulation device is further adapted to stimulate a parasympathetic nerve at least in a branch of a spinal cord dispatching number 10 and along the Coccygeal nerves originating at vertebrae S2-S4, preferably S4.

41. A system according to any of the preceding aspects, wherein the vasomotor tone of the wall portion defines the flow in the renal artery and thereby indirect the blood pressure.

Aspect group 379SE2: Hypertension_Local_Treatment_2

1. A system for treating a patient with hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to the autonomic nerve system to directly or indirectly control the dilation, contraction, or contraction and dilation, of a wall portion of the renal artery via a nerve innervating the renal artery, to affect a vasomotor tone of the renal artery; an implantable source of energy configured to energize the electrode arrangement; and a control unit operably connected to the stimulation device; wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes at least one of vasodilation, constriction, or alternating between vasodilation and constriction, of the renal artery to control the tonus in the wall of the renal artery.

2. The system according to aspect 1, wherein the vasomotor tone of the wall portion defines the flow in the renal artery and thereby indirect the blood pressure.

3. The system according to aspect 2, wherein the parasympathetic nerve comprises a branch of spinal cord dispatching nerve number 10, and the Coccygeal nerves vertebrae S2-S4, preferably S4.

3. The system according to any of the preceding aspects, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

4. The system according to any of the preceding aspects, wherein the electrode arrangement is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

5. The system according to aspect 4, wherein the support structure comprises a cuff portion configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

6. The system according to aspect 5, wherein the electrode arrangement is arranged on an inner surface of the cuff.

7. The system according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve.

8. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

9. The system according to aspect 8, wherein the electrical stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz. 10. The system according to aspect 8 or 9, wherein the electrical stimulation signal comprises a pulse width of 0.01-1 ms.

11. The system according to any of aspects 8 to 10, wherein the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.

12. The system according to any of the preceding aspects, further comprising a signal damping device configured to be arranged at the parasympathetic nerve, at a position between the stimulation device and the spinal cord.

13. The system according to aspect 12, wherein the signal damping device comprises an electrode arrangement configured to deliver an electric damping signal to the parasympathetic nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal generated by the stimulation device.

14. The system according to aspect 13, wherein the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal.

15. The system according to any of the preceding aspects, wherein the control unit is configured to be communicatively connected to a wireless remote control.

16. The system according to aspect 15, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

17. The system according to any of the preceding aspects, further comprising a blood pressure sensor configured to generate a signal indicating a blood pressure of the patient.

18. The system according to aspect 17, wherein the blood pressure sensor is configured to determine a local blood pressure in the renal artery.

19. The system according to aspect 17 or 18, wherein the blood pressure sensor is configured to determine a systemic blood pressure.

20. The system according to any of aspects 17-18, wherein the control unit is configured to receive the signal generated by the blood pressure sensor.

21. The system according to aspect 20, wherein the control unit is configured to control the operation of the stimulation device based on the received signal.

22. The system according to any of the preceding aspects, wherein the source of energy is configured to be implanted subcutaneously.

23. The system according to any of the preceding aspects, wherein the source of energy comprises at least one of a primary cell and a secondary cell.

24. The system according to any of the preceding aspects, wherein the control unit is configured to indicate a functional status of the source of energy. 25. The system according to aspect 24, wherein the functional status indicates a charge level of the source of energy.

26. The system according to any of aspects 1-23, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the wall portion and the blood flowing through the renal artery.

27. The system according to any of the preceding aspects, further comprising a coating arranged on at least one surface of at least one of the stimulation device, the implantable source of energy, and the control unit.

28. The system according to aspect 27, wherein the coating comprises at least one layer of a biomaterial.

29. The system according to aspect 28, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

30. The system according to aspect 28 or 29, wherein the biomaterial is fibrin-based.

31. The system according to any of aspects 28-30, further comprising a second coating arranged on the first coating.

32. The system according to aspect 31, wherein the second coating is a different biomaterial than said first coating.

33. The system according to aspect 32, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.

34. The system according to any one of aspects 28-33 wherein the coating comprises a drug encapsulated in a porous material.

35. The system according to any one of aspects 28-34, wherein the surface comprises a metal.

36. The system according to aspect 35, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.

37. The system according to any of aspects 28-36, wherein the surface comprises a micropattem.

38. The system according to aspect 37, wherein the micropattem is etched into the surface prior to insertion into the body.

39. The system according to aspect 37 or 38, further comprising a layer of a biomaterial coated on the micropattem.

40. A communication system for enabling communication between a display device and a system (100) according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the implantable device and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the implantable device, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the implantable device.

Aspect group 380SE: Hypertension Local Treatment Holder

1 A medical device comprising: an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of a smooth muscle tissue of the renal artery; a remote unit operably connected to the electrode arrangement and configured to generate the electric stimulation signal such that the electric stimulation signal causes a controlled vasodilation of the renal artery; wherein the remote unit is configured to be secured to a tissue wall of the patient; wherein the remote unit comprises: a first unit configured to be implanted at a first side of the tissue wall of the patient; a second unit configured to be implanted at a second side of the tissue wall; and a connecting unit configured to be arranged to extend through the tissue wall and to be mechanically attached to the first unit and the second unit; wherein the first unit and the second unit are provided with a shape and size hindering them from passing through the tissue wall.

2. The device according to aspect 1, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

3. The device according to aspect 2, wherein the electrode arrangement is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

4. The device according to aspect 3, wherein the support structure comprises a cuff portion configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

5. The device according to aspect 4, wherein the electrode arrangement is arranged on an inner surface of the cuff.

6. The device according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve.

7. The device according to any of the preceding aspects, wherein the remote unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

8. The device according to aspect 7, wherein the electrical stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

9. The device according to aspect 7 or 8, wherein the electrical stimulation signal comprises a pulse width of 0.01-1 ms. 10. The device according to any of aspects 7 to 9, wherein the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.

11. The device according to any of the preceding aspects, further comprising a signal damping device configured to be arranged at the nerve innervating the renal artery, at a position between the electrode arrangement and the spinal cord.

12. The device according to aspect 11, wherein the signal damping device is configured to deliver an electric damping signal to the nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal delivered by the electrode arrangement.

13. The device according to aspect 12, wherein the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal.

14. The device according to any of the preceding aspects, wherein the remote unit is configured to be communicatively connected to a wireless control.

15. The system according to aspect 14, wherein the remote unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

17. The device according to aspect 16, wherein the blood pressure sensor is configured to determine a local blood pressure in the renal artery.

18. The device according to aspect 16 or 17, wherein the blood pressure sensor is configured to determine a systemic blood pressure.

19. The device according to any of aspects 16-17, wherein the remote unit is configured to receive the signal generated by the blood pressure sensor.

20. The device according to aspect 19, wherein the remote unit is configured to generate the electric stimulation signal based on the received signal.

21. The device according to any of the preceding aspects, further comprising a source of energy configured to energize the electrode arrangement.

22. The device according to aspect 21, wherein the source of energy is arranged in the second unit.

23. The device according to aspect 21, wherein the source of energy configured to is configured to be implanted subcutaneously.

24. The device according to any of aspects 21-23, wherein the source of energy comprises at least one of a primary cell and a secondary cell. 25. The device according to any of aspects 21-24, wherein the remote unit is configured to indicate a functional status of the source of energy.

26. The device according to aspect 25, wherein the functional status indicates a charge level of the source of energy.

27. The device according to any of aspects 21-26, wherein the remote unit is configured to indicate a temperature of at least one of the source of energy, the wall portion and the blood flowing through the renal artery.

28. The device according to any of the preceding aspects, wherein: the first unit has a first cross-sectional area in a first plane and comprises a first surface configured to engage a first tissue surface of the first side of the tissue portion; the second unit has a second cross-sectional area in a second plane and comprises a second surface configured to engage a second tissue surface of the second side of the tissue portion; the connecting unit has a third cross-sectional area in a third plane; and the third cross-sectional area is smaller than the first and second cross-sectional areas, such that the first unit and the second unit are prevented from travelling through the tissue wall.

29. The device according to any of the preceding aspects, wherein the connecting unit has a circular cross-section.

30. The device according to any of the preceding aspects, wherein the connecting unit is hollow.

31. The device according to any of the preceding aspects, wherein at least one of the first and second units is configured to be threaded onto the connecting unit.

32. The device according to any of the preceding aspects, wherein the first and second unit forms a bolted joint with the connecting unit.

33. The device according to any of the preceding aspects, wherein the connecting unit is elastic.

34. The device according to any of the preceding aspects, further comprising a coating.

35. The device according to aspect 34, wherein the coating comprises silicone.

36. The device according to any of aspects 11-13, wherein the signal damping device is arranged in at least one of the first unit, second unit and the connecting unit.

37. The device according to any of aspects 16-20, wherein the sensor is arranged in at least one of the first unit, the second unit and the connecting unit.

38. The device according to any of aspects 21-27, wherein the source of energy is arranged in at least one of the first unit, the second unit and the connecting unit.

39. The device according to any of the preceding aspects, wherein at least one of the first unit, the second unit and the connecting unit comprises a wireless receiver configured to receive energy transmitted from outside the body of the patient. 40. The device according to any of the preceding aspects, wherein at least one of the first unit, the second unit and the connecting unit comprises a wireless transceiver for communicating wirelessly with an external device.

41. The device according to any of the preceding aspects, wherein the remote unit is configured to be implanted in a tissue wall forming part of at least one of: the diaphragm, the left or right crus, the medial or lateral arcuate ligament, the psoas major, the quadratus lumborum, the transverse abdominal wall, the psoas minor, the internal oblique abdominal wall, the iliacus, and the psoas major.

42. The medical device according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the electrode arrangement and the remote unit.

43. The medical device according to aspect 42, wherein the coating comprises at least one layer of a biomaterial.

44. The medical device according to aspect 43, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

45. The medical device according to aspect 43 or 44, wherein the biomaterial is fibrin-based.

46. The medical device according to any of aspects 42-45, further comprising a second coating (760b) arranged on the first coating.

47. The medical device according to aspect 46, wherein the second coating is a different biomaterial than said first coating.

48. The medical device according to aspect 47, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.

49. The medical device according to any one of aspects 43-48, wherein the coating comprises a drug encapsulated in a porous material.

50. The medical device according to any one of aspects 43-49, wherein the surface comprises a metal.

51. The medical device according to aspect 50, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead. 52. The medical device according to any of aspects 43-51, wherein the surface comprises a micropattem.

53. The medical device according to aspect 52, wherein the micropattem is etched into the surface prior to insertion into the body.

54. The system according to aspect 52 or 53, further comprising a layer of a biomaterial coated on the micropattem.

55. A communication system for enabling communication between a display device and a medical device according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the medical device and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the medical device, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the medical device.

56. A medical device according to any of the preceding aspects, wherein the vasomotor tone is affected by smooth muscle tissue of the wall of the renal artery. Aspect group 381SE1: Hypertension Local Treatment Automatic

1. A system for treating a patient suffering from hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of a smooth muscle tissue of the renal artery; an implantable sensor configured to generate a signal indicative of a blood pressure of the patient; and a control unit communicatively connected to the stimulation device and to the sensor device; wherein the control unit is configured to control an operation of the stimulation device, based on the signal generated by the sensor device, such that the electric stimulation signal causes a controlled vasodilation of the renal artery.

2. The system according to aspect 1, wherein the sensor comprises a pressure sensor configured to be arranged in a blood vessel of the patient.

3. The system according to aspect 1, wherein the sensor is configured to be arranged at an outer wall of a blood vessel of the patient.

4. The system according to aspect 3, wherein the sensor is configured to measure a pressure pulse wave transmitted from the blood flow to the outer wall of the blood vessel.

5. The system according to aspect 4, wherein the sensor comprises a strain gauge sensitive to strain in the outer wall of the blood vessel.

6. The system according to aspect 4 or 5, wherein the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the blood vessel and the pressure sensor.

7. The system according to aspect 3, wherein the sensor comprises a doppler radar sensor configured to measure the blood pressure in the blood vessel.

8. The system according to aspect 1, wherein the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor.

9. The system according to aspect 1, wherein the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.

10. The system according to aspect 9, wherein the sensor is a flow sensor configured to generate a signal indicative of a flow through a blood vessel.

11. The system according to any of the preceding aspects, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

12. The system according to aspect 11, wherein the control unit is configured to: compare the estimated blood pressure with a predetermined limit value; and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery.

13. The system according to aspect 11, wherein the control unit is configured to: monitor, over time, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking over time, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

14. The system according to any of the preceding aspects, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

15. The system according to any of the preceding aspects, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

16. The system according to any of the preceding aspects, wherein the electrode arrangement is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

17. The system according to aspect 16, wherein the support structure comprises a cuff portion configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

18. The system according to aspect 17, wherein the electrode arrangement is arranged on an inner surface of the cuff.

19. The system according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve.

20. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

21. The system according to aspect 20, wherein the electrical stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz. 22. The system according to aspect 20 or 21, wherein the electrical stimulation signal comprises a pulse width of 0.01-1 ms.

23. The system according to any of aspects 20 to 22, wherein the electrical stimulation signal comprises a pulse amplitude of 1-15 mA.

24. The system according to any of the preceding aspects, further comprising a signal damping device configured to be arranged at the nerve innervating the renal artery, at a position between the stimulation device and the spinal cord.

25. The system according to aspect 24, wherein the signal damping device comprises an electrode arrangement configured to deliver an electric damping signal to the nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal generated by the stimulation device.

26. The system according to aspect 25, wherein the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal.

27. The system according to aspect 24, wherein the signal damping device is configured to deliver an electric scrambling signal for disturbing the electrical stimulation signal passing the signal damping device.

28. The system according to any of the preceding aspects, further comprising a source of energy configured to energize at least one of the stimulation device, the sensor, and the control unit.

29. The system according to aspect 28, wherein the source of energy is arranged in the control unit.

30. The system according to aspect 28, wherein the source of energy is configured to be implanted subcutaneously.

31. The system according to any of aspects 28-30, wherein the source of energy comprises at least one of a primary cell and a secondary cell.

32. The system according to any of aspects 28-31, wherein the control unit is configured to indicate a functional status of the source of energy.

33. The system according to aspect 32, wherein the functional status indicates a charge level of the source of energy.

34. The system according to any of aspects 28-33, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the wall portion and the blood flowing through the renal artery.

35. The system according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the sensor, and the control unit. 36. The system according to aspect 35, wherein the coating comprises at least one layer of a biomaterial.

37. The system according to aspect 36, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

38. The system according to aspect 36 or 37, wherein the biomaterial is fibrin-based.

39. The system according to any of aspects 36-39, further comprising a second coating (760b) arranged on the first coating.

40. The system according to aspect 39, wherein the second coating is a different biomaterial than said first coating.

41. The system according to aspect 40, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.

42. The system according to any one of aspects 36-41, wherein the coating comprises a drug encapsulated in a porous material.

43. The system according to any one of aspects 36-42, wherein the surface comprises a metal.

44. The system according to aspect 43, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.

45. The system according to any of aspects 36-44, wherein the surface comprises a micropattem.

46. The system according to aspect 45, wherein the micropattem is etched into the surface prior to insertion into the body.

51. The system according toe alim 45 or 46, further comprising a layer of a biomaterial coated on the micropattem.

52. A communication system for enabling communication between a display device and a system according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the system and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the system, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the system.

Aspect group 381SE2: Hypertension Local Treatment Automatic

1. A system for treating a patient suffering from hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to a parasympathetic nerve affecting a wall portion of a renal artery of the patient to dilate the renal artery, wherein the parasympathetic nerve comprises at least one of a parasympathetic nerve from at least a branch of spinal cord dispatching nerve number 10 and the Coccygeal nerves originating from vertebrae S2-S4, preferably S4; an implantable sensor configured to generate a signal indicative of a blood pressure of the patient; and a control unit communicatively connected to the stimulation device and to the sensor device; wherein the control unit is configured to control an operation of the stimulation device, based on the signal generated by the sensor device, such that the electric stimulation signal causes a controlled vasodilation of the renal artery affecting the blood pressure regulating of the kidney, causing the general blood pressure to be lowered and thereby indirect control the hypertonia of the patient.

10. The system according to aspect 9, wherein the sensor is a flow sensor configured to generate a signal indicative of a flow through a blood vessel. 11. The system according to any of the preceding aspects, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

13. The system according to aspect 11, wherein the control unit is configured to: monitor, over time, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking overtime, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

20. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery. 21. The system according to aspect 20, wherein the electrical stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

22. The system according to aspect 20 or 21, wherein the electrical stimulation signal comprises a pulse width of 0.01-1 ms.

34. The system according to any of aspects 28-33, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the wall portion and the blood flowing through the renal artery. 35. The system according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the sensor, and the control unit.

36. The system according to aspect 35, wherein the coating comprises at least one layer of a biomaterial.

Aspect group 382SE1: Hypertension Local Treatment Cancellation

1. A system for treating a patient with hypertension, comprising: a stimulation device comprising a first electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of the renal artery; a signal damping device comprising a second electrode arrangement configured to deliver an electric damping signal to tissue of the patient; a control unit operably connected to the stimulation device and to the signal damping device, wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes a controlled vasodilation of the renal artery, and to control an operation of the signal damping device to damp or disturb the electric stimulation signal delivered by the stimulation device, thereby reducing at least one of a backward and a forward propagation of the electric stimulation.

2. The system according to aspect 1, wherein the second electrode arrangement is configured to deliver the electric damping signal to the nerve innervating the renal artery to damp or reduce transmission of the electric stimulation signal in the nerve.

3. The system according to aspect 2, wherein the second electrode arrangement is configured to deliver the electric damping signal at a position between the first electrode arrangement and a spinal cord of the patient.

4. The system according to aspect 1, wherein at least one of the first and second electrode arrangements comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

5. The system according to aspect 1, wherein at least one of the first and second electrode arrangements is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

6. The system according to aspect 5, wherein the support structure comprises a cuff configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

7. The system according to aspect 6, wherein at least one of the first and second electrode arrangements is arranged on an inner surface of the cuff.

8. The system according to any of the preceding aspects, wherein each of the stimulation device and the signal damping device is configured to deliver an electric stimulation signal and an electric damping signal, respectively, to a parasympathetic nerve. 9. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electric stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

10. The system according to aspect 9, wherein the electric stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

11. The system according to aspect 9 or 10, wherein the electric stimulation signal comprises a pulse width of 0.01-1 ms.

12. The system according to any of aspects 9 to 11, wherein the electric stimulation signal comprises a pulse amplitude of 1-15 mA.

13. The system according to any of the preceding aspects, wherein the control unit if configured to generate the electric damping signal based on the electric stimulation signal.

14. The system according to aspect 13, wherein the electric damping signal is out of phase with the electric stimulation signal.

15. The system according to aspect 13, wherein the electric stimulation signal and the electric damping signal are pulsed signals, and wherein a frequency of the electric damping signal is higher than a frequency of the electric stimulation signal.

16. The system according to aspect 15, wherein the frequency of the electric damping signal is at least twice the frequency of the electric stimulation signal.

17. The system according to aspect 13, wherein the signal damping device is configured to deliver an electric scrambling signal for disturbing the electric stimulation signal passing the signal damping device.

18. The system according to any of the preceding aspects, further comprising a signal processing means configured to measure the electric stimulation signal received at the signal damping device and to generate the electric damping signal based on the received electric stimulation signal.

19. The system according to any of the preceding aspects, wherein the control unit is configured to be communicatively connected to a wireless remote control.

20. The system according to aspect 19, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

21. The system according to any of the preceding aspects, further comprising a source of energy for energising the first and second electrode arrangements.

22. The system according to aspect 21, wherein the source of energy is configured to be implanted subcutaneously.

23. The system according to aspect 21 or 22, wherein the source of energy comprises at least one of a primary cell and a secondary cell. 24. The system according to any of aspects 21 to 23, wherein the control unit is configured to indicate a functional status of the source of energy.

25. The system according to aspect 24, wherein the functional status indicates a charge level of the source of energy.

26. The system according to any of aspects 21-25, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the nerve and tissue adjacent to the nerve.

27. The system according to any of the preceding aspects, further comprising a blood pressure sensor configured to generate a signal indicating a blood pressure of the patient.

28. The system according to aspect 27, wherein the blood pressure sensor is configured to determine a local blood pressure in the renal artery.

29. The system according to aspect 27 or 28, wherein the blood pressure sensor is configured to determine a systemic blood pressure.

30. The system according to any of aspects 27-29, wherein the control unit is configured to receive the signal generated by the blood pressure sensor.

31. The system according to aspect 30, wherein the control unit is configured to control the operation of the stimulation device based on the received signal.

32. The system according to any of the preceding aspects, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the damping device, and the control unit.

33. The system according to aspect 32, wherein the coating comprises at least one layer of a biomaterial.

34. The system according to aspect 33, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

35. The system according to aspect 33 or 34, wherein the biomaterial is fibrin-based.

36. The system according to any of aspects 33-36, further comprising a second coating (760b) arranged on the first coating.

37. The system according to aspect 36, wherein the second coating is a different biomaterial than said first coating.

38. The system according to aspect 37, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.

39. The system according to any one of aspects 36-38, wherein the coating comprises a drug encapsulated in a porous material.

40. The system according to any one of aspects 33-39, wherein the surface comprises a metal.

41. The system according to aspect 40, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead. 42. The system according to any of aspects 33-41, wherein the surface comprises a micropattem.

43. The system according to aspect 42, wherein the micropattem is etched into the surface prior to insertion into the body.

44. The system according to aspect 42 or 43, further comprising a layer of a biomaterial coated on the micropattem.

45. A communication system for enabling communication between a display device and a system according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the system and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the system, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the system. Aspect group 382SE2: Stimulation of spinal cord dispatching nerves

1. A system for treating a patient with stimulation of a spinal cord dispatching nerve, comprising: a stimulation device comprising a first electrode arrangement configured to deliver an electric stimulation signal to at least one spinal cord dispatching nerve of a patient to treat disease affected by anyone of the spinal cord dispatching nerves; a signal damping device comprising a second electrode arrangement configured to deliver an electric damping signal to dampen a stimulation distributed in a retrograde direction back to the brain of the patient; a control unit operably connected to the stimulation device and to the signal damping device, wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery, and to control an operation of the signal damping device to damp or disturb the electric stimulation signal delivered by the stimulation device.

2. The system according to aspect 1, wherein the second electrode arrangement is configured to deliver the electric damping signal to the same nerve to damp or reduce transmission of the electric stimulation signal in the backward direction of the nerve, preventing stimulation of the brain.

3. The system according to aspect 2, wherein the second electrode arrangement is configured to deliver the electric damping signal at a position between the first electrode arrangement and a proximal position of the at least one spinal cord dispatching nerve stimulated.

4. The system according to aspect 1, wherein at least one of the first and second electrode arrangements comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the nerve.

5. The system according to aspect 1, wherein at least one of the first and second electrode arrangements is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on or close relation to the at least one spinal cord dispatching nerve.

6. The system according to aspect 5, wherein the support structure comprises a cuff configured to be arranged at least partly around the at least one spinal cord dispatching nerve.

8. The system according to any of the preceding aspects, wherein each of the stimulation device and the signal damping device is configured to deliver an electric stimulation signal and an electric damping signal, respectively, to at least one of a parasympathetic and at least one spinal cord dispatching nerve.

9. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electric stimulation signal for affecting the at least one of a parasympathetic and at least one spinal cord dispatching nerve.

22. The system according to aspect 21, wherein the source of energy is configured to be implanted subcutaneously. 23. The system according to aspect 21 or 22, wherein the source of energy comprises at least one of a primary cell and a secondary cell.

24. The system according to any of aspects 21 to 23, wherein the control unit is configured to indicate a functional status of the source of energy.

40. The system according to any one of aspects 33-39, wherein the surface comprises a metal. 41. The system according to aspect 40, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.

42. The system according to any of aspects 33-41, wherein the surface comprises a micropattem.

45. A communication system for enabling communication between a display device and a system according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the system and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the system, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the system. 46. The system according to any of aspects 1 - 45, wherein the spinal cord dispatching nerve stimulation is adapted to treat at least one of problems related to the food passageway and associated organs, as well as other organs and functions in the body, such as at least one of: an eye, a lacrimal gland, mucosa membranes, a submaxillary gland, a sublingual gland, a parotid gland, a heart, a trachea, a bronchi, an esophagus, a stomach, intestines, abdominal blood vessels, liver and bile duct, pancreas, adrenal gland, rectum, as well as via coccyges nerves: kidney, a urinary bladder, gonads, external genitalia.

47. The system according to any of aspects 1 - 46, wherein the spinal cord dispatching nerve stimulation is adapted to treat a multitude of diseases comprising; high blood pressure, obesity, urinary dysfunction, intestinal dysfunction, hormonal balance etc.

Aspect group 382SE3: Stimulation of spinal cord nerves

1. A system for treating a patient with stimulation of a spinal cord dispatching nerve, comprising: a stimulation device comprising a first electrode arrangement configured to deliver an electric stimulation signal to at least one spinal cord dispatching nerve of a patient to treat disease affected by anyone of the spinal cord dispatching nerves; a signal damping device comprising a second electrode arrangement configured to deliver an electric damping signal to damp stimulation distributed in a retrograde direction back up to the brain of the patient, which negatively could harm the patient; a control unit operably connected to the stimulation device and to the signal damping device, wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes vasodilation of the renal artery, and to control an operation of the signal damping device to damp or disturb the electric stimulation signal delivered by the stimulation device.

5. The system according to aspect 1, wherein at least one of the first and second electrode arrangements is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on or in close relation to the at least one spinal cord dispatching nerve.

8. The system according to any of the preceding aspects, wherein each of the stimulation device and the signal damping device is configured to deliver an electric stimulation signal and an electric damping signal, respectively, to at least one of a parasympathetic and at least one spinal cord dispatching nerve. 9. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electric stimulation signal for affecting the at least one of a parasympathetic and at least one spinal cord dispatching nerve.

45. A communication system for enabling communication between a display device and a system according to any of the preceding aspects, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the system and configured for wireless communication with the server, and a computing unit configured for: running a control software for creating the control commands for the operation of the system, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the system.

46. The system according to any of the preceding aspecta, wherein the spinal cord dispatching nerve stimulation is adapted to treat at least one of problems related to the food passageway and associated organs, as well as many organs and functions in the body, at least one of; an eye, a lacrimal gland, mucosa membranes, a submaxillary gland, a sublingual gland, a parotid gland, a heart, a trachea, a bronchi, an esophagus, a stomach, intestines, abdominal blood vessels, liver and bile duct, pancreas, adrenal gland, rectum, as well as via coccyges nerves: kidney, a urinary bladder, gonads, external genitalia. 47. The system according to any of the preceding aspects, wherein the spinal cord dispatching nerve stimulation is adapted to treat a multitude of diseases comprising; high blood pressure, obesity, urinary dysfunction, intestinal dysfunction, hormonal balance etc.

Aspect group 404SE: Hypertension_Local_Treatment_Energising

1. A system for treating a patient with hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a dilation of the renal artery; a implantable energy receiver configured to energize the electrode arrangement; an energy source configured to transfer energy wirelessly to the energy receiver; and a control unit operably connected to the stimulation device; wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes a controlled vasodilation of the renal artery.

2. The system according to aspect 1, wherein the energy receiver comprises an inductive coil arrangement configured to receive the wirelessly transmitted energy from the energy source.

3. The system according to aspect 1 or 2, wherein the energy source is configured to be arranged outside the bod of the patient.

4. The system according to aspect 1 or 2, wherein the energy source is configured to be implanted in the patient.

5. The system according to aspect 4, wherein the energy source is configured to be charged by energy transferred wirelessly from outside the body of the patient

6. The system according to any of the preceding aspects, wherein the control unit is configured to generate control instructions for controlling the operation of the stimulation device, and to transmit the control instructions wirelessly from outside of the body of the patient to the stimulation device.

7. The system according to aspect 6, wherein the control unit comprises an external part configured to be arranged outside the body of the patient and an internal part configured to be implanted in the patient, and wherein the internal and external parts are configured to communicate wirelessly with each other.

8. The system according to aspect 7, wherein the internal and external parts are configured to communicate with each other by means of radiofrequency signals or inductive signals.

9. The system according to any of the preceding aspects, further comprising: a sensor configured to generate a signal indicative of the vasodilation of the renal artery; wherein: the control unit is communicatively connected to the sensor device; and configured to control the operation of the stimulation device based on the signal generated by the sensor device. 10. The system according to aspect 9, wherein the sensor is configured to measure a change in the vasomotor tone of the smooth muscle tissue of the renal artery in response to the electrical stimulation of the wall portion.

11. The system according to aspect 9, wherein the sensor is configured to measure a degree of vasodilation of the renal artery.

12. The system according to aspect 9, wherein the sensor is configured to measure a flow of blood through the renal artery.

13. The system according to aspect 9, wherein the sensor is configured to measure a blood pressure of the patient.

14. The system according to aspect 9, wherein the sensor comprises a pressure sensor configured to be arranged in a blood vessel of the patient.

15. The system according to aspect 9, wherein the sensor is configured to be arranged at an outer wall of a blood vessel of the patient.

16. The system according to aspect 15, wherein the sensor is configured to measure a pressure pulse wave transmitted from the blood flow to the outer wall of the blood vessel.

17. The system according to aspect 15, wherein the sensor comprises a strain gauge sensitive to strain in the outer wall of the blood vessel.

18. The system according to aspect 15 or 16, wherein the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the blood vessel and the pressure sensor.

19. The system according to aspect 15, wherein the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor.

20. The system according to aspect 9, wherein the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.

21. The system according to any of aspects 9-20, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

22. The system according to aspect 21, wherein the control unit is configured to: compare the estimated blood pressure with a predetermined limit value; and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery. 23. The system according to aspect 21, wherein the control unit is configured to: monitor, overtime, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking over time, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

24. The system according to any of the preceding aspects, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

25. The system according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve.

26. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

27. The system according to aspect 26, wherein the electrical stimulation signal comprises at least one of: a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz, a pulse width of 0.01-1 ms, and a pulse amplitude of 1-15 mA.

28. The system according to any of the preceding aspects, further comprising a signal damping device configured to be arranged at the parasympathetic nerve, at a position between the stimulation device and the spinal cord.

29. The system according to aspect 28, wherein the signal damping device comprises an electrode arrangement configured to deliver an electric damping signal to the parasympathetic nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal generated by the stimulation device.

30. The system according to aspect 29, wherein the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal.

31. The system according to any of the preceding aspects, wherein the stimulation device is adapted to stimulate a parasympathetic nerve system, such as at least a branch of spinal cord dispatching nerve number 10 and the Coccygeal nerves originating from vertebrae S2-S4, preferably S4. 32. The system according to any of the preceding aspects, wherein the stimulation device is adapted to affect a vasomotor tone of a smooth muscle tissue of the renal artery.

Aspect group 405 SE: Hypertension Local Treatment Communication

1. A system for treating a patient with hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of the renal artery; a source of energy configured to energize the electrode arrangement; and a control unit operably connected to the stimulation device; wherein the control unit is configured to: generate control instructions for controlling the operation of the stimulation device such that the electric stimulation signal causes a controlled vasodilation of the renal artery; and transmit the control instructions wirelessly to the stimulation device.

2. The system according to aspect 1, wherein the control unit comprises an external part configured to be arranged outside the body of the patient and an internal part configured to be implanted in the patient, and wherein the internal and external parts are configured to communicate wirelessly with each other.

3. The system according to aspect 2, wherein the internal and external parts are configured to communicate with each other by means of radiofrequency signals or inductive signals.

4. The system according to any of the preceding aspects, wherein the source of energy is configured to be arranged outside the body of the patient and to energize the electrode arrangement by transferring energy wirelessly to the electrode arrangement.

5. The system according to aspect 4, further comprising an implantable energy receiver configured to receive energy, transferred wirelessly from the source of energy, and transmit the received energy to the electrode arrangement.

6. The system according to aspect 5, wherein the implantable energy receiver comprises an inductive coil arrangement configured to receive the wirelessly transmitted energy from the source of energy.

7. The system according to aspect 1, wherein the source of energy is configured to be implanted in the patient.

8. The system according to aspect 7, wherein the source of energy is configured to be charged by energy transferred wirelessly from outside the body of the patient

9. The system according to aspect 8, further comprising an implantable energy receiver configured to receive energy, transferred wirelessly from outside the body of the patient, and transmit the received energy to the source of energy implanted in the patient. 10. The system according to aspect 9, wherein the implantable energy receive comprises an inductive coil arrangement configured to receive the wirelessly transmitted energy.

11. The system according to any of the preceding aspects, further comprising: a sensor configured to generate a signal indicative of the vasodilation of the renal artery; wherein: the control unit is communicatively connected to the sensor device; and configured to control the operation of the stimulation device based on the signal generated by the sensor device.

12. The system according to aspect 11, wherein the sensor is configured to measure a change in the vasomotor tone of the smooth muscle tissue of the renal artery in response to the electrical stimulation of the wall portion.

13. The system according to aspect 11, wherein the sensor is configured to measure a degree of vasodilation of the renal artery.

14. The system according to aspect 11, wherein the sensor is configured to measure a flow of blood through the renal artery.

15. The system according to aspect 11, wherein the sensor is configured to measure a blood pressure of the patient.

16. The system according to aspect 11, wherein the sensor comprises a pressure sensor configured to be arranged in a blood vessel of the patient.

17. The system according to aspect 11, wherein the sensor is configured to be arranged at an outer wall of a blood vessel of the patient.

18. The system according to aspect 17, wherein the sensor is configured to measure a pressure pulse wave transmitted from the blood flow to the outer wall of the blood vessel.

19. The system according to aspect 17, wherein the sensor comprises a strain gauge sensitive to strain in the outer wall of the blood vessel.

20. The system according to aspect 19 or 20, wherein the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the blood vessel and the pressure sensor.

21. The system according to aspect 11, wherein the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor.

22. The system according to aspect 11, wherein the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.

23. The system according to any of aspects 11-22, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

24. The system according to aspect 23, wherein the control unit is configured to: compare the estimated blood pressure with a predetermined limit value; and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery.

25. The system according to aspect 23, wherein the control unit is configured to: monitor, overtime, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking over time, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

26. The system according to any of the preceding aspects, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

27. The system according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve.

28. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

29. The system according to aspect 28, wherein the electrical stimulation signal comprises at least one of: a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz, a pulse width of 0.01-1 ms, and a pulse amplitude of 1-15 mA.

30. The system according to any of the preceding aspects, further comprising a signal damping device configured to be arranged at the parasympathetic nerve, at a position between the stimulation device and the spinal cord.

31. The system according to aspect 30, wherein the signal damping device comprises an electrode arrangement configured to deliver an electric damping signal to the parasympathetic nerve, and wherein the electric damping signal is configured to at least partly counteract the electrical stimulation signal generated by the stimulation device. 32. The system according to aspect 31, wherein the signal damping device further comprises a signal processing means configured to measure the electrical stimulation signal received at the signal damping device and generate the electric damping signal based on the received electrical stimulation signal. 33. The system according to any of the preceding aspects, wherein the stimulation device is configured to affect a vasomotor tone of the smooth muscle tissue of the renal artery.

Aspect group 406SE: Hypertension Elongated Holder

1. A system for treating a patient with hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of the renal artery; a source of energy configured to energize the electrode arrangement; a control unit operably connected to the stimulation device; and an elongated holding device configured to be attached to an outer wall of the renal artery such that a length direction of the holding device extends along a flow direction of the renal artery, wherein the holding device is further configured to support the electrode arrangement to allow the electrode arrangement to deliver the electric stimulation signal to the wall portion; wherein the control unit is configured to control an operation of the stimulation device such that the electric stimulation signal causes a controlled vasodilation of the renal artery.

2. The system according to aspect 1, wherein the electrode arrangement is attached to a surface portion of the holding device and configured to rest against the outer wall of the renal artery.

3. The system according to aspect 1 or 2, further comprising an attachment device configured to fixate the holding device to the renal artery.

4. The system according to aspect 3, wherein the attachment device comprises at least one of a suture configured to be sutured to the renal artery and a clamping device configured to at least partly encircle the renal artery.

5. The system according to aspect 3, wherein the attachment device is configured to be attached to the holding device and a tissue portion external to the renal artery.

6. The system according to any of the preceding aspects, wherein the holding device is flexible.

7. The system according to any of the preceding aspects, wherein at least one of the source of energy and the control unit is accommodated in the holding device.

8. The system according to any of the preceding aspects, wherein the electrode arrangement comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

9. The system according to any of the preceding aspects, wherein the electrode arrangement is configured to electrically stimulate a sacral nerve. 10. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

11. The system according to aspect 10, wherein the electrical stimulation signal comprises at least one of: a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz, a pulse width of 0.01-1 ms, and a pulse amplitude of 1-15 mA.

15. The system according to any of the preceding aspects, further comprising a blood pressure sensor configured to generate a signal indicating a blood pressure of the patient.

16. The system according to aspect 15, wherein the control unit is configured to control the operation of the stimulation device based on the signal.

17. The system according to any of the preceding aspects, wherein the stimulation device is configured to affect a vasomotor tone of the smooth muscle tissue of the renal artery

Aspect group 407SE: Hypertension Compliant Cuff

1. A system for treating a patient suffering from hypertension, comprising: a stimulation device comprising an electrode arrangement configured to be able to deliver an electric stimulation signal to at least one of: a wall portion of a renal artery and a parasympathetic nerve innervating the renal artery of the patient, to affect a vasomotor tone of of the renal artery; a source of energy configured to energize the electrode arrangement; a control unit operably connected to the stimulation device and configured to control an operation of the stimulation device such that the electric stimulation signal causes a controlled vasodilation of the renal artery; and a holding device configured to support the electrode arrangement at the outer wall of the renal artery to allow the electrode arrangement to deliver the electric stimulation signal to the wall portion, wherein the holding device is configured to at least partly define a passage through which the renal artery passes; and wherein the holding device is configured to allow a width of the passage to follow changes in a width of the renal artery, such that the width of the passage increases with increased vasodilation and decreases with decreasing vasodilation.

2. The system according to aspect 1, wherein the holding device comprises a flexible portion configured to rest against the outer wall of the renal artery and to follow a motion of the outer wall as the width of the renal artery varies in response to the vasodilation.

3. The system according to aspect 1, wherein the holding device comprises a cuff arranged to at least partly encircle the renal artery.

4. The system according to aspect 3, wherein the cuff comprises at least one abutment element having a varying volume and configured to rest against the outer wall portion of the renal artery.

5. The system according to aspect 4, wherein the abutment element comprises an inflatable element configured to vary its volume in response to the width of the renal artery varying with the vasodilation.

6. The system according to aspect 4 or 5, wherein the abutment element comprises a pneumatic or hydraulic element having an adjustable volume.

7. The system according to aspect 6, further comprising a fluid reservoir, wherein the pneumatic or hydraulic element is fluidly connected to the fluid reservoir.

8. The system according to any of the preceding aspects, further comprising a pressure sensor device arranged to sense generate a signal indicative of a contact pressure between the holding device and the outer wall of the renal artery, wherein the control unit is further configured to cause the width of the passage of the holding device to vary based on the signal from the pressure sensor.

9. The system according to aspect 8, wherein the control unit is configured to operate the holding device to maintain a substantially constant contact pressure between the holding device and the outer wall as the width of the renal artery varies with the vasodilation.

10. The system according to aspect 8, wherein the control unit is configured to control an operation of the stimulation device based on the signal generated by the sensor device.

11. The system according to aspect 1, further comprising a sensor configured to generate a signal indicative of a blood pressure of the patient; wherein the control unit is configured to control an operation of the stimulation device based on the signal generated by the sensor device.

12. The system according to aspect 11, wherein the sensor is integrated in the holding device.

13. The system according to aspect 12, wherein the sensor is configured to measure a pressure pulse wave transmitted from the blood flow in the renal artery to the outer wall of the renal artery.

14. The system according to aspect 12 or 13, wherein the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the renal artery and the pressure sensor.

15. The system according to any of aspects 11-13, wherein the sensor comprises a strain gauge sensitive to strain in the outer wall of the renal artery.

16. The system according to any of aspects 11-15, wherein the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor.

17. The system according to aspect 11, wherein the sensor is a flow sensor configured to generate a signal indicative of a flow through the renal artery.

18. The system according to aspect 11, wherein the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.19.

The system according to any of aspects 11-18, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

20. The system according to aspect 19, wherein the control unit is configured to: compare the estimated blood pressure with a predetermined limit value; and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery. 21. The system according to aspect 19, wherein the control unit is configured to: monitor, over time, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking overtime, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

22. The system according to any of the preceding aspects, wherein the control unit is configured to generate a pulsed electrical stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

23. The system according to aspect 22, wherein the electrical stimulation signal comprises at least one of: a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz, a pulse width of 0.01-1 ms, and a pulse amplitude of 1-15 mA.

27. The system according to any of the preceding aspects, wherein the stimulation device is configured to affect a vasomotor tone of the smooth muscle tissue of the renal artery Aspect group 408SE: Hypertension lntraluminar Heating

1. A system for treating a patient with hypertension, comprising: a stimulation device having a heating member configured to be implanted inside a renal artery of the patient; an implantable source of energy configured to energize the stimulation device; and a control unit operably connected to the stimulation device; wherein the control unit is configured to control an operation of the stimulation device such that heat is exchanged between the heating member and a wall portion of the renal artery to cause a controlled a of the renal artery.

2. The system according to aspect 1, wherein the source of energy is configured to be implanted inside the renal artery.

3. The system according to aspect 2, wherein the source of energy is integrated in the heating member.

4. The system according to aspect 2 or 3, wherein the source of energy is configured to be charged by energy transferred from outside the renal artery.

5. The system according to aspect 4, wherein the source of energy is configured to be charged by energy wirelessly transferred from outside the renal artery.

6. The system according to aspect 1, wherein the heating member is configured to be heated by energy transferred from outside the renal artery.

7. The system according to aspect 6, wherein the heating member is configured to be heated by energy transferred from outside the renal artery by means of a wired connection.

8. The system according to aspect 6, wherein the heating member is configured to be inductively heated by energy transferred from outside the renal artery.

9. The system according to any of the preceding aspects, wherein the heating member has a tubular shape having an outer surface configured to rest against an inner surface of the renal artery.

10. The system according to any of the preceding aspects, wherein the heating member defines a passage through which a blood flow of the renal artery is allowed to pass, and wherein the heating member is configured to follow change in a width of the renal artery such that a width of the passage increases with increased vasodilation and decreases with decreasing vasodilation.

11. The system according to aspect 10, wherein the heating member comprises a flexible portion configured to allow the heating member to follow the change in width of the renal artery.

12. The system according to aspect 10, wherein the heating member comprises a shape memory material configured to vary the width of the passage in response to a varying temperature of the heating member, thereby allowing the heating member to follow the changes in the width of the renal artery. 13. The system according to any of the preceding aspects, wherein the heating member comprises a biocompatible material configured to promote fibrotic tissue growth thereon.

14. The system according to aspect 13, wherein the heating member is configured to be at least partly encapsulated by fibrotic tissue when implanted in the renal artery.

15. The system according to any of the preceding aspects, wherein the heating member is configured to be secured to an inner surface of the renal artery.

16. The system according to aspect 15, wherein the heating member is configured to be secured to the inner surface by means of sutures or staples.

17. The system according to any of the preceding aspects, further comprising: a sensor configured to generate a signal indicative of the vasodilation of the renal artery; wherein: the control unit is communicatively connected to the sensor device; and configured to control the operation of the stimulation device based on the signal generated by the sensor device.

18. The system according to aspect 17, wherein the sensor is configured to measure a flow of blood through the renal artery.

19. The system according to aspect 17, wherein the sensor is configured to measure a blood pressure of the patient.

20. The system according to aspect 17, wherein the sensor comprises a pressure sensor configured to be arranged in a blood vessel of the patient.

21. The system according to aspect 17, wherein the sensor is configured to be arranged at an outer wall of a blood vessel of the patient.

22. The system according to aspect 21, wherein the sensor is configured to measure a pressure pulse wave transmitted from the blood flow to the outer wall of the blood vessel.

23. The system according to aspect 21, wherein the sensor comprises a strain gauge sensitive to strain in the outer wall of the blood vessel.

24. The system according to aspect 21 or 22, wherein the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the blood vessel and the pressure sensor.

25. The system according to aspect 17, wherein the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor.

26. The system according to aspect 17, wherein the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.

27. The system according to any of aspects 17-26, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

28. The system according to aspect 27, wherein the control unit is configured to: compare the estimated blood pressure with a predetermined limit value; and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery. 29. The system according to aspect 27, wherein the control unit is configured to: monitor, over time, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking over time, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

Aspect group 409SE: Hypertension lntraluminar Expansion

1. A system for treating a patient with hypertension, comprising: a dilation device having an expansion member configured to be implanted inside a renal artery of the patient and to engage at least a portion of an inner circumferential surface of the renal artery, wherein the expansion member expandable to increase a width of the renal artery; an implantable source of energy configured to energize the dilation device; and a control unit operably connected to the dilation device; wherein the control unit is configured to control an operation of the dilation device to induce a controlled vasodilation of the renal artery.

3. The system according to aspect 2, wherein the source of energy is integrated in the expansion member.

6. The system according to aspect 1, wherein the expansion member is configured to be powered by energy transferred from outside the renal artery.

7. The system according to aspect 6, wherein the expansion member is configured to be powered by energy transferred from outside the renal artery by means of a wired connection.

8. The system according to aspect 6, wherein the expansion member is configured to be inductively powered by energy transferred from outside the renal artery.

9. The system according to any of the preceding aspects, wherein the expansion member is configured to be operated by means of mechanic, hydraulic or thermal action.

10. The system according to aspect 9, further comprising an operation device configured to control the operation of the expansion member.

11. The system according to aspect 10, wherein the operation device comprises a hydraulic reservoir in fluid connection with the expansion member.

12. The system according to aspect 9, wherein the expansion member comprises a shape memory material configured to vary a shape of the expansion member in response to a varying temperature of the expansion member.

13. The system according to any of the preceding aspects, wherein the expansion member has a tubular shape having an outer surface configured to rest against an inner surface of the renal artery. 14. The system according to any of the preceding aspects, wherein the expansion member defines a passage through which a blood flow of the renal artery is allowed to pass, and wherein the expansion member is configured to cause vasodilation by increasing a width of the passage.

15. The system according to any of the preceding aspects, wherein the expansion member comprises a biocompatible material configured to promote fibrotic tissue growth thereon.

16. The system according to aspect 15, wherein the expansion member is configured to be at least partly encapsulated by fibrotic tissue when implanted in the renal artery.

17. The system according to any of the preceding aspects, wherein the expansion member is configured to be secured to an inner surface of the renal artery.

18. The system according to aspect 17, wherein the expansion member is configured to be secured to the inner surface by means of sutures or staples.

19. The system according to any of the preceding aspects, further comprising: a sensor configured to generate a signal indicative of the vasodilation of the renal artery; wherein: the control unit is communicatively connected to the sensor device; and configured to control the operation of the stimulation device based on the signal generated by the sensor device.

20. The system according to aspect 19, wherein the sensor is configured to measure a flow of blood through the renal artery.

21. The system according to aspect 19, wherein the sensor is configured to measure a blood pressure of the patient.

22. The system according to aspect 18, wherein the sensor comprises a pressure sensor configured to be arranged in a blood vessel of the patient.

23. The system according to aspect 18, wherein the sensor is configured to be arranged at an outer wall of a blood vessel of the patient.

24. The system according to aspect 23, wherein the sensor is configured to measure a pressure pulse wave transmitted from the blood flow to the outer wall of the blood vessel.

25. The system according to aspect 23, wherein the sensor comprises a strain gauge sensitive to strain in the outer wall of the blood vessel.

26. The system according to aspect 23 or 24, wherein the sensor comprises a contact pressure sensor sensitive to a pressing force between the outer wall of the blood vessel and the pressure sensor.

27. The system according to aspect 19, wherein the sensor comprises a light source and a light sensor, and wherein the signal is based on a light coupling efficiency between the light source and the light sensor. 28. The system according to aspect 19, wherein the sensor is configured to generate a signal indicative of a vascular resistance in a portion of the circulatory system of the patient.

29. The system according to any of aspects 19-28, wherein the control unit is configured to: determine an estimated blood pressure based the on signal generated by the sensor; wherein the determined blood pressure is a local blood pressure in the renal artery or a systemic blood pressure.

30. The system according to aspect 29, wherein the control unit is configured to: compare the estimated blood pressure with a predetermined limit value; and in response to the estimated blood pressure being below the limit value, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure exceeding the limit value, control the operation of the stimulation device to cause vasodilation of the renal artery.

31. The system according to aspect 29, wherein the control unit is configured to: monitor, over time, the estimated blood pressure based on the signal generated by the sensor; and in response to the estimated blood pressure sinking overtime, control the operation of the stimulation device to cause vasoconstriction of the renal artery; and in response to the estimated blood pressure rising over time, control the operation of the stimulation device to cause vasodilation of the renal artery.

Claims

Aspect group 382SE1: Hypertension Local Treatment Cancellation CLAIMS

2. The system according to claim 1, wherein the second electrode arrangement is configured to deliver the electric damping signal to the nerve innervating the renal artery to damp or reduce transmission of the electric stimulation signal in the nerve.

3. The system according to claim 2, wherein the second electrode arrangement is configured to deliver the electric damping signal at a position between the first electrode arrangement and a spinal cord of the patient.

4. The system according to claim 1, wherein at least one of the first and second electrode arrangements comprises a plurality of electrode elements, each of which being configured to engage and electrically stimulate the wall portion of the renal artery or the nerve innervating the renal artery.

5. The system according to claim 1, wherein at least one of the first and second electrode arrangements is arranged on a surface portion of a support structure, and wherein the surface portion is configured to be placed on the wall portion of the renal artery or on the nerve innervating the renal artery.

6. The system according to claim 5, wherein the support structure comprises a cuff configured to be arranged at least partly around the wall portion of the renal artery or the nerve innervating the renal artery.

7. The system according to claim 6. wherein at least one of the first and second electrode arrangements is arranged on an inner surface of the cuff.

8. The system according to any of the preceding claims, wherein each of the stimulation device and the signal damping device is configured to deliver an electric stimulation signal and an electric damping signal, respectively, to a parasympathetic nerve.

9. The system according to any of the preceding claims, wherein the control unit is configured to generate a pulsed electric stimulation signal for affecting the vasomotor tone of the smooth muscle tissue of the renal artery.

10. The system according to claim 9, wherein the electric stimulation signal comprises a frequency of 30 Hz or less, such as 5-25 Hz, such as 10-20 Hz.

11. The system according to claim 9 or 10, wherein the electric stimulation signal comprises a pulse width of 0.01-1 ms.

12. The system according to any of claims 9 to 11, wherein the electric stimulation signal comprises a pulse amplitude of 1-15 mA.

13. The system according to any of the preceding claims, wherein the control unit if configured to generate the electric damping signal based on the electric stimulation signal.

14. The system according to claim 13, wherein the electric damping signal is out of phase with the electric stimulation signal.

15. The system according to claim 13, wherein the electric stimulation signal and the electric damping signal are pulsed signals, and wherein a frequency of the electric damping signal is higher than a frequency of the electric stimulation signal.

16. The system according to claim 15, wherein the frequency of the electric damping signal is at least twice the frequency of the electric stimulation signal.

17. The system according to claim 13, wherein the signal damping device is configured to deliver an electric scrambling signal for disturbing the electric stimulation signal passing the signal damping device.

18. The system according to any of the preceding claims, further comprising a signal processing means configured to measure the electric stimulation signal received at the signal damping device and to generate the electric damping signal based on the received electric stimulation signal.

19. The system according to any of the preceding claims, wherein the control unit is configured to be communicatively connected to a wireless remote control.

20. The system according to claim 19, wherein the control unit comprises an internal signal transmitter configured to receive and transmit communication signals from/to an external signal transmitter.

21. The system according to any of the preceding claims, further comprising a source of energy for energising the first and second electrode arrangements.

22. The system according to claim 21, wherein the source of energy is configured to be implanted subcutaneously.

23. The system according to claim 21 or 22, wherein the source of energy comprises at least one of a primary cell and a secondary cell.

24. The system according to any of claims 21 to 23, wherein the control unit is configured to indicate a functional status of the source of energy.

25. The system according to claim 24, wherein the functional status indicates a charge level of the source of energy.

26. The system according to any of claims 21-25, wherein the control unit is configured to indicate a temperature of at least one of the source of energy, the nerve and tissue adjacent to the nerve.

27. The system according to any of the preceding claims, further comprising a blood pressure sensor configured to generate a signal indicating a blood pressure of the patient. 220

28. The system according to claim 27, wherein the blood pressure sensor is configured to determine a local blood pressure in the renal artery.

29. The system according to claim 27 or 28, wherein the blood pressure sensor is configured to determine a systemic blood pressure.

30. The system according to any of claims 27-29, wherein the control unit is configured to receive the signal generated by the blood pressure sensor.

31. The system according to claim 30, wherein the control unit is configured to control the operation of the stimulation device based on the received signal.

32. The system according to any of the preceding claims, further comprising a coating (760) arranged on at least one surface of at least one of the stimulation device, the damping device, and the control unit.

33. The system according to claim 32, wherein the coating comprises at least one layer of a biomaterial.

34. The system according to claim 33, wherein the biomaterial comprises at least one drug or substance with antithrombotic and/or antibacterial and/or antiplatelet characteristics.

35. The system according to claim 33 or 34, wherein the biomaterial is fibrin-based.

36. The system according to any of claims 33-36, further comprising a second coating (760b) arranged on the first coating.

37. The system according to claim 36, wherein the second coating is a different biomaterial than said first coating.

38. The system according to claim 37, wherein the first coating comprises a layer of perfluorocarbon chemically attached to the surface, and wherein the second coating comprises a liquid perfluorocarbon layer.

39. The system according to any one of claims 36-38, wherein the coating comprises a drug encapsulated in a porous material. 221

40. The system according to any one of claims 33-39, wherein the surface comprises a metal.

41. The system according to claim 40, wherein the metal comprises at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin and lead.

42. The system according to any of claims 33-41, wherein the surface comprises a micropattem.

43. The system according to claim 42, wherein the micropattem is etched into the surface prior to insertion into the body.

44. The system according to claim 42 or 43, further comprising a layer of a biomaterial coated on the micropattem.

45. A communication system for enabling communication between a display device and a system according to any of the preceding claims, the communication system comprising: a display device, a server, and an external device, wherein the display device comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the server, the implant control interface being provided by the external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the server, destined for the external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user; wherein the server comprises: a wireless communication unit configured for wirelessly receiving an implant control interface from the external device and wirelessly transmitting the implant control interface to the display device, the wireless communication unit further being configured for wirelessly receiving implant control user input from the display device and wirelessly transmitting the implant control user input to the external device, and wherein the external device comprises: a wireless communication unit configured for wireless transmission of control commands to the system and configured for wireless communication with the server, and a computing unit configured for: 222 running a control software for creating the control commands for the operation of the system, transmitting a control interface to the server, destined for the display device, receiving implant control user input generated at the display device, from the server, and transforming the user input into the control commands for wireless transmission to the system.