Limiting Device

Abstract

The present disclosure relates to a system for treating a patient having a disorder related to the patient's intestine (100), the system comprising one or more electrical stimulators (10) having one or more electrodes (11) for electrically stimulating muscle or nerve tissue of the intestine, each of the one or more electrical stimulators (10) comprising a wireless energy receiver (R) configured to wirelessly receive energy for stimulating the muscle or nerve tissue.

Description

[Technical Field]

[0001] The present invention relates to a system for treating a patient having a disorder related to the patient's bowel. More specifically, the treatment involves electrically stimulating the patient's bowel. Methods of implanting and using such a system are also disclosed. [Background technology]

[0002] Intestinal disorders can be caused by trauma, congenital defects, cancer, or other illnesses such as constipation or incontinence. WO 2011 / 128124 A1 discloses a system for regulating the flow of intestinal contents through the intestine. In this particular application, a reservoir for intestinal contents is formed from surgically modified intestine by cutting along the line of contact between laterally adjacent sections of a curved section of intestine, connecting the resulting upper and lower halves of the intestine to form the intestinal wall of the reservoir, and the system is designed to empty such a reservoir for intestinal contents. More specifically, the prior art system includes a pump adapted to act on the intestinal wall to reduce the volume of the reservoir, thereby emptying the reservoir. The pump may be an electrically stimulated pump, a hydraulically actuated pump, or / and a mechanically actuated pump. The system further includes an inlet valve upstream of the reservoir and an outlet valve downstream of the reservoir.

[0003] The electrostimulation pump includes an electrical stimulation device for electrically stimulating muscle or nerve tissue in the intestinal wall by applying electrical pulses to the intestinal wall, particularly a series of electrical pulses, to induce at least partial contractions. For this purpose, the electrical stimulation device is comprised of one or more electrodes adapted to generate electrical pulses. This is a very gentle method of contracting the reservoir. By sequentially electrically stimulating different portions of the intestinal wall in the direction of natural intestinal content flow, intestinal contents are pumped along the intestinal reservoir, resulting in emptying of the intestinal reservoir. More specifically, the electrodes of the electrostimulation pump are attached to one or more retention devices, which may be cable-shaped or have other longitudinal, stripe-shaped, rod-shaped, or plate-shaped configurations. The electrodes can be arranged in one or more rows along the length of the retention device. When implanted, the longitudinal retention devices are arranged side-by-side to substantially cover the entire intestinal reservoir on one or the other side of the reservoir.

[0004] The retention device is embedded in a flexible web so that it can follow the movement of the intestinal reservoir when portions of the intestinal reservoir individually contract due to selective electrical stimulation. Alternatively, the longitudinal retention device is embedded in a surgically created fold in the intestinal wall of the reservoir. Alternatively, the electrodes are embedded directly in the intestinal wall, either individually or in groups, without being carried on a common retention device. Furthermore, WO 2011 / 128124 A1 proposes that instead of providing multiple longitudinal retention devices with electrodes, the electrical stimulation device be integrally formed on at least one side of the reservoir, making handling and manufacturing easier.

[0005] In addition to the electrically stimulated pump, the pump disclosed in WO 2011 / 128124 A1 may also include a contractile pump implanted in the patient's body to externally act on the intestinal wall to at least partially contract the intestinal reservoir mechanically or hydraulically. The electrically stimulated pump and the contractile pump may act on the same portion of the intestinal wall, electrically stimulating different portions of the intestinal wall over time and simultaneously contracting the respective portions of the reservoir in the direction of natural intestinal content flow, thereby pumping intestinal contents along the reservoir. In particular, the contractile pump may only partially contract the intestinal reservoir during operation to avoid damaging the intestinal tissue, but complete contraction, and thus emptying of the reservoir, may be achieved by additionally electrically stimulating portions of the intestinal wall in the manner described above.

[0006] Because the intestinal reservoir itself has lost its natural peristaltic function due to surgical modification, the electrically stimulated pump, for example, when the reservoir is unconfined by the constriction pump, stimulates different parts of the intestinal wall in a wave-like manner (peristalsis), thereby pumping the intestinal contents along the reservoir in the natural flow direction of the intestinal contents, thereby improving the filling of the intestinal reservoir with the intestinal contents supplied to the reservoir. An outlet valve provided at the downstream end of the intestinal reservoir is closed while the reservoir is filled, preventing the intestinal contents from accidentally leaking out of the reservoir.

[0007] It is an object of the present invention to further improve a system for treating a patient with a bowel-related disorder involving electrical stimulation of the patient's bowel, which system may comprise all of the features as described above in relation to WO2011 / 128124A1, but with certain modifications as described below. Summary of the Invention

[0008] According to one aspect of the present disclosure, a system for treating a patient having a disorder related to the patient's bowel includes a plurality of electrical stimulators having one or more electrodes for electrically stimulating muscle or nerve tissue of the bowel, each of the one or more electrical stimulators including a wireless energy receiver configured to wirelessly receive energy to stimulate the muscle or nerve tissue.

[0009] That is, the electrical stimulators are not connected by wires or in any other way. Physically, the electrical stimulators are independent of each other. As such, the electrical stimulators can be placed on or near the intestine, or even implanted in the intestinal wall, and can follow any intestinal movement. In particular, such intestinal movement can be triggered by electrical stimulation via the respective electrical stimulator, by contraction via the aforementioned contractile pump, and / or by contraction via any other mechanical, hydraulic, or other type of contractile device. In other words, the one or more electrical stimulators are rather flexible, and thanks to the physical independence of the electrical stimulators, they maintain flexibility over time, minimizing the risk of such flexibility decreasing due to fibrosis growing over and enveloping the system and the electrical stimulators.

[0010] The system preferably includes one or more wireless energy transmitters configured to transmit energy to some or all of the one or more electrical stimulation devices. Thus, one energy transmitter is provided to supply energy to two or more electrical stimulation devices. More specifically, one wireless energy transmitter may be configured to transmit energy to all of the one or more electrical stimulation devices, or at least one, and preferably all, of the multiple wireless energy transmitters may be configured to transmit energy to some of the one or more electrical stimulation devices. In this way, the complexity of the system can be minimized. Of course, more than one energy transmitter may be provided, each configured to supply energy to one or more electrical stimulation devices.

[0011] The wireless energy receiver of each of the one or more electrical stimulators may include a secondary coil, and at least one, and preferably each, of the wireless energy transmitters may include a primary coil configured to induce a voltage in some or all of the secondary coils of the one or more electrical stimulators. In this manner, energy may be wirelessly transmitted from the energy transmitter to the energy receiver via the primary and secondary coils.

[0012] Alternatively, the system may include a respective wireless energy transmitter for each one of the one or more electrical stimulation devices to individually transfer energy to each one of the one or more electrical stimulation devices, in which case the wireless energy receiver of each of the one or more electrical stimulation devices may include a secondary coil to wirelessly transmit energy, and each of the respective wireless energy transmitters may include a primary coil configured to transmit energy to the secondary coil of each one of the one or more electrical stimulation devices.

[0013] Preferably, RFID technology is used to wirelessly transfer energy from the energy transmitter to the energy receiver. RFID technology is widely known, and the transfer of energy via the primary coil and secondary coil described above is a well-known method of transferring energy using RFID technology. More specifically, the wireless energy receiver can be configured to receive energy via RFID pulses.

[0014] Preferably, the system includes a feedback unit configured to provide feedback regarding the amount of energy received by the wireless energy receiver, such as via RFID pulses, and the system is configured to adjust the amount of energy transferred based on the feedback. More specifically, the amount of received RFID pulsed energy can be adjusted based on the feedback to successively increase the pulse frequency until a satisfactory level is reached.

[0015] Preferably, each of the one or more electrical stimulators includes a rechargeable energy storage unit, such as a rechargeable battery or capacitor, for temporarily storing at least a portion of the wirelessly received energy. The rechargeable energy storage unit may be charged over time so that the amount of energy required by the electrode or electrodes of the respective electrical stimulator to stimulate muscle or nerve tissue is available when needed. Such amount of energy may be small in any event, since muscle contraction occurs autonomously once the electrical stimulation reaches or exceeds the activation potential of the corresponding nerve.

[0016] Preferably, each of the one or more electrical stimulation devices includes an internal controller. The internal controller can perform a variety of functions, but its primary function consists of controlling the timing and amount of energy applied to the electrode or electrodes of the electrical stimulation device to stimulate nerve or muscle tissue. Another important function is to control, and possibly store, the amount of energy received via the wireless energy receiver. The internal controller may also be responsible for communicating with an external controller and / or a remote controller. For example, such communication may relate, among other things, to energy transfer via the energy receiver and / or the timing and / or amount of energy applied to the electrode or electrodes.

[0017] In particular, the internal controller can be configured to wirelessly receive electrode control data for controlling stimulation of muscle or nerve tissue. In this manner, since the electrical stimulators are physically independent of each other, not only energy but also data transfer occurs wirelessly. Such data can be received from an implanted external controller or from a remote controller outside the patient's body.

[0018] Preferably, the internal controller receives electrode control data wirelessly via the wireless energy receiver. In other words, the same port may be used to receive both energy and data. In particular, the energy transmitted to and received by the electrical stimulator via the wireless energy receiver may be appropriately modulated, such that the modulation defines and thus carries a signal that can be decoded and interpreted as data by the internal controller. This is well-known technology, particularly in RFID technology, where RFID signals are used to transmit both energy and information.

[0019] More specifically, each internal controller of one or more electrical stimulation devices may be individually addressable by an external or remote controller using an individual code, i.e., a code unique to each internal controller. This is particularly useful when one external or remote controller is used to control multiple electrical stimulation devices and / or when one wireless transmitter is used to wirelessly transmit energy to the wireless energy receivers of multiple electrical stimulation devices. For example, when operating electrical stimulation devices sequentially, such as to stimulate the intestines in a wave-like pattern, each electrical stimulation device may be individually addressed using the individual code of its corresponding internal controller. Typically, such individual codes are placed at the beginning of the data transmitted to the internal controller. In this way, only one or more desired electrical stimulation devices may be instructed to electrically stimulate a portion of the intestine at a given time and / or only one or more desired electrical stimulation devices may receive and, in some cases, store energy received through the wireless energy receiver.

[0020] As previously mentioned, the system may include an external controller configured to communicate wirelessly with the internal controller. The external controller may be either an implantable external controller configured to be implanted within the patient's body, or a remote controller configured to communicate directly with the internal controller from outside the patient's body. Alternatively, the system may comprise a remote controller configured to communicate with the implantable external controller from outside the patient's body. In the latter case, there are at least three types of controllers: an internal controller within each one of the electrical stimulators, at least one external controller within the patient's body for communicating with the one or more internal controllers, and preferably only one remote controller outside the patient's body for communicating with the one or more implantable external controllers. The remote controller is preferably operable by the patient and / or a caregiver.

[0021] The remote controller can be configured to communicate with the implantable external controller via electrical wiring. Preferably, however, the remote controller is configured to communicate with the implantable external controller wirelessly, which is more convenient for the patient and / or caregiver. Energy and / or data transfer between the remote controller and the implantable external controller can be achieved in the same manner as energy and / or data transfer to (and from) the internal controller of the electrical stimulation device. In either case, the remote controller is preferably configured to be worn on the patient's skin.

[0022] The system may comprise a number of electrical stimulators, which may be arranged at a number of different locations along the portion of the intestine to be electrically stimulated, i.e., in one or more rows, and / or on one or two or more, particularly two opposing, sides of the intestine. For example, four, five, six, seven, eight, nine, ten, eleven, twelve, or more than twelve electrical stimulators may be provided. Each electrical stimulator may consist of a single electrode or a plurality of two or more electrodes.

[0023] In one embodiment of the present disclosure, the system is configured to electrically stimulate muscle or nerve tissue by one or more electrodes of the electrical stimulation device sufficient to cause the intestinal muscles to contract to an extent that causes the intestines to contract, i.e., the system can function as a contraction device by electrically stimulating the contraction of the intestinal muscles.

[0024] In this context, the one or more electrical stimulation devices may form part of an electrically stimulated pump such as those described above in relation to the prior art disclosed in WO2011 / 128124A1, which pump is configured to advance intestinal contents downstream through the patient's intestine, for example by sequentially electrically stimulating different parts of the intestine in a wave-like or peristaltic manner.

[0025] More specifically, similar to the system disclosed in WO2011 / 128124A1, the systems described herein may be configured and particularly suitable for use with intestinal reservoir sections formed from surgically altered intestine cut along the line of mutual contact of laterally adjacent sections of a bend in the intestine, with the upper and lower halves of the cut intestine being connected to form the intestinal wall of the reservoir section. More specifically, at least the electrodes of the one or more electrical stimulation devices may be configured to be implanted in surgically created folds in the patient's intestine.

[0026] In addition to the one or more electrical stimulation devices, the system may further include at least one mechanical or hydraulic constriction device configured to be implanted adjacent to the exterior of the patient's intestine to contract the intestine from the exterior. The electrical stimulation device and the mechanical or hydraulic constriction device may be configured to act on the same portion of the patient's intestine, as is generally known from WO 2011 / 128124 A1. In this case, the mechanical or hydraulic constriction device may form part of a pump configured to advance intestinal contents downstream through the patient's intestine. Alternatively, the mechanical or hydraulic constriction device may have the function of a valve configured to open and close the intestine by contraction, thereby controlling the flow of intestinal contents through the intestine, particularly the flow of intestinal contents into or out of the intestine. For example, the valve may form an artificial sphincter near the patient's rectum or near the patient's stoma. The electrical stimulation device may support the respective functions of the mechanical or hydraulic constriction device. These may be used individually or together to form a jejunal device for emptying respective portions of the patient's intestine.

[0027] In another embodiment of the present disclosure, a system is configured to electrically stimulate, via one or more electrodes of an electrical stimulation device, muscle or nerve tissue in a region of the intestine that has been sufficiently constricted by a medical device, such as at least one mechanical or hydraulic constriction device, to increase blood flow through the intestinal tissue. The objective is to mobilize the tissue wall in contact with the constriction device. The body tends to react to medical implants because they are foreign bodies and because they mechanically interact with the body's tissue. Exposing tissue to prolonged engagement and pressure from a mechanical, hydraulic, or other type of constriction device can deprive tissue cells of oxygen and nutrients, leading to tissue deterioration, atrophy, and ultimately necrosis. This can result in device migration, including penetration through the tissue wall. Therefore, it is desirable to mobilize tissue cells to stimulate blood flow and increase the tissue's resistance to pressure from the implant. In this regard, it is preferable to configure the system so that the electrical stimulation of muscle or nerve tissue to increase blood flow through the intestinal tissue can be adjusted at a low level that is not sufficient to cause the intestine to contract.

[0028] communication According to further aspects of the present disclosure, the security of the system against unauthorized third-party intervention can be increased. This is particularly important in the context of wireless communications, which can be easily intercepted and subsequently exploited by third parties. Accordingly, the system is preferably configured to do at least one of the following: Wireless communications to and from the controller of the system are encrypted; - signing data transmitted from the controller via wireless communication; -Authentication of users of the system includes inputting patient authentication data.

[0029] Preferably, the encrypted wireless communication involves public key encryption and private key decryption, such as the well-known RSA encryption. Other encryption methods may be implemented as well. Preferably, a further level of security is provided in that the private key may be a composite key derived by combining at least a first key and a second key.

[0030] Similarly, with regard to signing of data transmitted wirelessly from a controller, such as from the external or remote controller described above to an internal controller, the signature may involve a private key and subsequent verification of the signed data may involve a corresponding public key.

[0031] Preferably, the data communication includes both encryption and signing. RSA encryption technology allows for both data encryption and digital signing. In the encryption / decryption process, the sender encrypts the data using the receiver's public key, and the receiver subsequently decrypts the data using the receiver's private key. Meanwhile, in the signing / authentication process, the sender signs the (encrypted) data using their private key, and the receiver authenticates the signature using the sender's public key.

[0032] With respect to user authentication involving input of patient authentication data, the system can include a verification unit configured to obtain the patient authentication data. For example, the verification unit can include at least one of a fingerprint reader, a retina scanner, a camera, a graphical user interface for entering a code, and a microphone. Only after positive verification by the verification unit are certain functions of the system enabled. For example, positive verification can enable a controller to process certain data or open a communication channel between two controllers of the system, such as a wireless communication channel.

[0033] Alternatively or additionally, the system may include a sensory generator for generating sensations detectable by the patient's senses. In this case, the patient can input authentication data related to what the patient senses into the system. Authenticating the user then involves verifying, by a verification unit, that the authentication data input by the user matches data from the sensory generator related to the sensation generated by the sensory generator. Again, certain functions of the system are enabled only after positive verification by the verification unit. For example, positive verification may enable a controller to process certain data or open a communication channel between two controllers of the system, such as a wireless communication channel.

[0034] In this context, the sensation generator is configured to generate at least one of the following sensations detectable by the patient's senses: - the vibration may include, for example, a mechanical vibration of a fixed frequency; This sound may involve the superposition of mechanical vibrations of fixed frequencies, for example The optical signal may comprise a non-visible light pulse, such as an infrared pulse, The optical signal comprises, for example, a visual light pulse; - Electrical signals including current pulses The thermal signal may for example comprise a heat pulse.

[0035] The electrode may include an exposed electrode portion configured to form a metal-tissue interface with the tissue of the intestinal wall, thereby allowing faradaic charge transfer to be the primary charge transfer mechanism across said interface.

[0036] Alternatively, the electrode may include an electrode portion at least partially covered by a dielectric material configured to form a dielectric-tissue interface with the tissue of the intestinal wall, thereby reducing the faradaic portion of the charge transfer mechanism across said interface.

[0037] The placement of the electrical stimulation device may be configured to allow at least two electrodes to be placed on opposite sides of the patient's intestine.

[0038] Communication and Housing Further provided is an external device configured to communicate with an implantable medical device when implanted in a patient, the external device comprising a display device and a housing unit configured to mechanically and detachably connect to the display device, the housing comprising a first communication unit for receiving communications from the display device and a second communication unit for wirelessly transmitting communications to the implantable medical device.

[0039] According to one embodiment, the external device comprises a portable electronic device.

[0040] According to one embodiment, the external device is configured to communicate with the implantable medical device to change the operational state of the implantable medical device. An advantage of this embodiment is that the operational state of the implantable medical device can be changed remotely.

[0041] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device, an advantage of which is that communication with the display device can be achieved without the need for wires.

[0042] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using a first communication frequency, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication frequency, the first and second communication frequencies being different. An advantage of this embodiment is that the possibility of interference is reduced.

[0043] According to one embodiment, the second communication unit is configured to wirelessly communicate with the implantable medical device using electromagnetic waves at a frequency of 100 kHz or less.

[0044] According to one embodiment, the second communication unit is configured to wirelessly communicate with the implantable medical device using electromagnetic waves at frequencies below 40 kHz. An advantage of this embodiment is that titanium, which is commonly used in medical devices, is transparent to electromagnetic waves below 40 kHz.

[0045] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using electromagnetic waves with a frequency above 100 kHz, an advantage of this embodiment is that the frequency spectrum below 100 kHz remains noise-free for communication with the medical implantable device.

[0046] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using a first communication protocol, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication protocol, the first and second communication protocols being different. An advantage of this embodiment is that the protocols for communication of the first and second communication units can be independently selected depending on which protocol is more suited to the needs of the communication units.

[0047] According to one embodiment, the housing unit includes a first antenna configured for wireless communication with the display device and a second antenna configured for wireless communication with the implantable medical device. An advantage of this embodiment is that the antennas can be independently selected for communication between the first and second communication units depending on which antenna better suits the needs of the communication units.

[0048] According to one embodiment, the first communication unit is a wired communication unit for wired communication with the display device. An advantage of this embodiment is that the communication of the first communication unit is reliable and secure.

[0049] According to one embodiment, the display device comprises a first communication unit for communicating with the housing unit and a second communication unit for wirelessly communicating with a second external device, an advantage of this embodiment being that it allows communication with additional external devices, thereby providing redundancy and reliability.

[0050] According to one embodiment, the second communication unit of the display device is configured to communicate with a second external device via the Internet. An advantage of this embodiment is that the display device can communicate with devices at a distance.

[0051] According to one embodiment, the first communication unit of the display device is a wireless communication unit for wireless communication with the housing unit, an advantage of this embodiment is that the communication unit can be connected to the housing unit without using wires.

[0052] According to one embodiment, the first communication unit of the display device is configured to wirelessly communicate with the housing unit using a first communication frequency, and the second communication unit of the display device is configured to wirelessly communicate with the second external device using a second communication frequency, the first and second communication frequencies being different. An advantage of this embodiment is that the possibility of interference is reduced and the signal-to-interference and noise ratio is improved.

[0053] According to one embodiment, a first communication unit of the display device is configured to wirelessly communicate with the housing unit using a first communication protocol, and a second communication unit of the display device is configured to wirelessly communicate with a second external device using a second communication protocol, the first and second communication protocols being different. An advantage of this embodiment is that the first and second communication units can independently select a protocol for communication depending on which protocol is more suitable for the needs of the communication units.

[0054] According to one embodiment, the display device comprises a first antenna configured for wireless communication with the housing and a second antenna configured for wireless communication with a second external device, an advantage of this embodiment being that the antennas for communication between the first and second communication units can be independently selected depending on which antenna better suits the needs of the communication units.

[0055] According to one embodiment, the first communication unit is a wired communication unit for wired communication with the housing unit, an advantage of this embodiment being that the communication of the first communication unit is reliable and secure.

[0056] According to one embodiment, the display device is configured to display a user interface to the patient. An advantage of this embodiment is that the patient can communicate with the housing unit using a display device that is familiar to them.

[0057] According to one embodiment, the housing unit is configured to transmit information regarding the display of the user interface to the display device, an advantage of this embodiment is that the patient can receive the information using a display device that is familiar to them.

[0058] According to one embodiment, the display device is configured to receive input from the patient regarding communication between the implantable medical device and the display device, and to transmit signals to the housing unit based on the received input. An advantage of this embodiment is that the patient can communicate with the housing unit using a display device that is familiar to them.

[0059] According to one embodiment, the display device comprises a touch screen configured to display a user interface and receive input from the patient. An advantage of this embodiment is that it allows the patient to interact with information in a familiar manner.

[0060] According to one embodiment, the housing unit is configured to display a user interface to the patient. An advantage of this embodiment is that the housing unit can receive user input.

[0061] According to one embodiment, the first communication unit of the housing unit is configured to receive, using the second communication unit, communications from the implantable medical device relating to input from the patient and to wirelessly transmit a signal to the implantable medical device based on the received input. An advantage of this embodiment is that the housing unit acts as an extra node in the communication between the display device and the implantable medical device, thereby allowing for communication monitoring.

[0062] According to one embodiment, the second communication unit of the housing unit is configured to communicate wirelessly with the implantable medical device using a standard network protocol, an advantage of which is that the communication unit is inexpensive to implement and the protocol is reliable.

[0063] According to one embodiment, the standard network protocol is one of the following list: a radio frequency type protocol, an RFID type protocol, a WLAN type protocol, a Bluetooth type protocol, a BLE type protocol, an NFC type protocol, a 3G / 4G / 5G type protocol, a GSM type protocol.

[0064] According to one embodiment, the second communication unit of the housing unit comprises a Bluetooth transceiver.

[0065] According to one embodiment, the second communication unit of the housing unit is configured to wirelessly communicate with the implantable medical device using a proprietary network protocol. An advantage of this embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.

[0066] According to one embodiment, the second communication unit of the housing unit comprises an UWB transceiver, the advantage being that high data rates can be communicated via the second communication unit.

[0067] According to one embodiment, the first communication unit of the housing unit is configured to communicate wirelessly with the display device using a standard network protocol, the advantages of this embodiment being that the communication unit is inexpensive to implement and the protocol is reliable.

[0068] According to one embodiment, the standard network protocol is an NFC-type protocol. The advantage of this embodiment is that it limits the distance between communicating devices and therefore provides protection against eavesdropping attacks.

[0069] According to one embodiment, the first communication unit of the housing unit is configured to wirelessly communicate with the display device using a proprietary network protocol. An advantage of this embodiment is that the housing unit is compatible with implantable medical devices that use proprietary network protocols.

[0070] According to one embodiment, the communication range of the first communication unit of the housing unit is smaller than the communication range of the second communication unit of the housing unit, an advantage of this embodiment is that energy is saved by selecting the first communication unit when its communication range is sufficient.

[0071] According to one embodiment, the communication range of the first communication unit of the display device is smaller than the communication range of the second communication unit of the display device, an advantage of this embodiment is that energy is saved by selecting the first communication unit when its communication range is sufficient.

[0072] According to one embodiment, at least one of the housing unit and the display device is configured to allow communication between the housing unit and the display device based on the distance between the housing unit and the display device. An advantage of this embodiment is that distance is used as a security and authorization factor.

[0073] According to one embodiment, at least one of the housing unit and the display device is configured to enable communication between the housing unit and the display device based on the housing unit being mechanically connected to the display device, an advantage of this embodiment being improved security against man-in-the-middle attacks.

[0074] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the implantable medical device based on the distance between the housing unit and the implantable medical device. An advantage of this embodiment is that distance is used as a safety and authorization factor.

[0075] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communications received from the display device, an advantage of this embodiment being that the encrypted communications are protected from access by unwanted third parties.

[0076] According to one embodiment, the housing unit is further adapted to transmit encrypted communications to the implantable medical device using the second communication unit, an advantage of this embodiment being that the encrypted communications are protected from access by unwanted third parties.

[0077] According to one embodiment, the second communication unit of the display device is configured to be disabled to enable at least one of communication between the display device and the housing unit and communication between the housing unit and the implantable medical device.

[0078] The display device in any of the embodiments described herein may be a wearable device or a handset, the advantage of this embodiment being that the device is mobile and can be used wherever needed.

[0079] According to one embodiment, the housing unit constitutes a case for the wearable device or handset, the advantage of which is that it can protect the wearable device or handset from mechanical damage.

[0080] Further provided is a housing unit configured to communicate with an implantable medical device when implanted in a patient, the housing unit being configured to mechanically connect to a display device and comprising a first communication unit for communicating with the display device and a second communication unit for wirelessly communicating with the implantable medical device.

[0081] According to one embodiment, the display device is a wearable device or a mobile phone, and the housing unit constitutes a case for the wearable device or the mobile phone.

[0082] According to one embodiment, the first communication unit is a wireless communication unit for wirelessly communicating with the display device.

[0083] According to one embodiment, the first communication unit is configured to wirelessly communicate with the display device using a first communication frequency, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication frequency, and the first and second communication frequencies are different.

[0084] According to one embodiment, the housing unit is configured to transmit information regarding the display of the user interface to the display device.

[0085] According to one embodiment, the housing unit is configured to receive patient input from a display device.

[0086] According to one embodiment, the housing unit is configured to display a user interface to the patient.

[0087] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the display device based on a distance between the housing unit and the display device.

[0088] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the display device based on the housing unit being mechanically connected to the display device.

[0089] According to one embodiment, the housing unit is configured to enable communication between the housing unit and the implantable medical device based on a distance between the housing unit and the implantable medical device.

[0090] According to one embodiment, the housing unit further comprises an encryption unit configured to encrypt communications received from the display device.

[0091] According to one embodiment, the housing unit is further adapted to send encrypted communications to the implantable medical device using the second communications unit.

[0092] According to one embodiment, when the housing is mechanically connected to the display device, the minimum bounding box of the housing unit and the display device is not more than 10% wider, not more than 10% longer, and not more than 100% taller than the minimum bounding box of the display device.

[0093] According to one embodiment, the housing unit includes one or more switches configured for use by the patient when the housing is not mechanically connected to the display device.

[0094] According to one embodiment, the switch is at least partially covered by the display when the display is mechanically connected to the housing unit.

[0095] According to one embodiment, at least a portion of the housing flexes to mechanically connect to the display device.

[0096] According to one embodiment, at least a portion of the housing is configured to sandwich a display device.

[0097] According to one embodiment, the housing is configured to cover at least one side of the display device when mechanically connected to the display device.

[0098] According to one embodiment, the housing is configured to be mechanically connected to a display device by means of a device that is mechanically connected to the housing and the display device.

[0099] General Security Module Also provided is an implantable controller for an implantable medical device. The implantable controller includes a wireless transceiver for wireless communication with an external device, a security module, and a central unit configured to communicate with the wireless transceiver, the security module, and the implantable medical device. The wireless transceiver is configured to receive a communication from the external device including at least one instruction for the implantable medical device and to transmit the received communication to the central unit. The central unit is configured to transmit a secure communication derived from the communication received from the external device to the security module, the security module being configured to decrypt at least a portion of the secure communication and / or verify the authenticity of the secure communication. The security module is configured to transmit a response communication to the central unit, and the central unit is configured to communicate at least one instruction to the implantable medical device, the at least one instruction being based on the response communication or a combination of the response communication and the communication received from the external device.

[0100] According to one embodiment, the security module comprises a set of rules for accepting communications from a central device.

[0101] According to one embodiment, the wireless transceiver is configured to be placed in an off mode in which wireless communications cannot be sent or received by the wireless transceiver, and the set of rules includes a rule that provides that communications from the central unit are accepted only when the wireless transceiver is placed in the off mode.

[0102] According to one embodiment, the set of rules includes a rule that provides that the radio transceiver will only accept communications from the central unit if it has been in off mode for a specified period of time.

[0103] According to one embodiment, the central device is configured to verify the digital signature of the communication received from the external device.

[0104] According to one embodiment, the set of rules includes a rule that provides that a communication from the central unit is accepted only if the digital signature of the received communication is verified by the central unit.

[0105] According to one embodiment, the central device is configured to check the size of the communication received from the external device.

[0106] According to one embodiment, the set of rules includes a rule that provides that a communication from the central unit is accepted only if the size of the received communication is verified by the central unit.

[0107] The wireless transceiver of any of the preceding embodiments may be configured to receive a message from an external device that is encrypted with at least first and second layers of encryption, and the central unit may be configured to decrypt the first layer of encryption and transmit at least a portion of the message that constitutes the second layer of encryption to the security module. The security module may be configured to decrypt the second layer of encryption and transmit a response communication to the central unit based on the portion of the message decrypted by the security module.

[0108] According to one embodiment, the central device may be configured to decrypt the portion of the message that includes the digital signature so that the digital signature can be verified by the central device.

[0109] According to one embodiment, the central device is configured to decrypt the portion of the message that includes the message size information so that the message size can be verified by the central device.

[0110] According to one embodiment, the central device is configured to decrypt the first and second parts of the message, the first part including a checksum for verifying the authenticity of the second part.

[0111] According to one embodiment, the response communication sent from the security module includes a checksum, and the central device may be configured to use the received checksum to verify the authenticity of at least a portion of the message decrypted by the central device.

[0112] According to one embodiment, the set of rules includes rules relating to data transfer rates between the central unit and the security modules.

[0113] The security module in any embodiment of this specification may be configured to decrypt the portion of the message that includes the digital signature that was encrypted with a second layer of encryption so that the digital signature can be verified by the security module.

[0114] The central unit may be configured to be able to decode some of the communications received from the external unit only when the wireless transceiver is placed in the off mode.

[0115] According to one embodiment, the central unit is capable of communicating at least one command to the implantable medical device only when the wireless transceiver is placed in the off mode.

[0116] According to one embodiment, the implantable controller is configured to receive, using a wireless transceiver, a message from an external device including a first unencrypted portion and a second encrypted portion, decrypt the encrypted portion, and verify authenticity of the unencrypted portion using the decrypted portion.

[0117] According to one embodiment, the central device is configured to transmit the encrypted portion to the security module, receive a response communication from the security module based on the information contained in the encrypted portion being decrypted by the security module, and use the response communication to verify the authenticity of the unencrypted portion.

[0118] According to one embodiment, the unencrypted portion comprises at least a portion of at least one instruction to the implantable medical device.

[0119] The implantable controller may be configured to use the wireless transceiver to receive a message from an external device that includes information related to at least one of a physiological parameter of the patient and a physical parameter of the implantable medical device, and to verify the authenticity of the message using the received information.

[0120] The patient's physiological parameters may include at least one of body temperature, heart rate, and saturation value.

[0121] The physical or functional parameters of the implanted medical device may include at least one of a current setting or value of the implanted medical device, an advance directive sent to the implanted medical device, and an ID of the implanted medical device.

[0122] According to one embodiment, the portions of the message that make up the information are encrypted, and the central device is configured to send the encrypted portions to the security module and receive a response communication from the security module based on the information decrypted by the security module.

[0123] According to one embodiment, the security module comprises a hardware security module including at least one hardware-based key, which may correspond to a hardware-based key in an external device or may be a hardware-based key on a key card connectable to the external device.

[0124] According to one embodiment, the security module comprises a software security module including at least one software-based key. The software-based key may correspond to a software-based key in an external device. The software-based key may correspond to a software-based key on a key card connectable to the external device. In any embodiment, the security module may comprise a combination of software-based keys and hardware-based keys.

[0125] In any of the foregoing embodiments, the implantable controller may include at least one cryptographic processor.

[0126] The wireless transceiver, in either embodiment, may be configured to receive communications from a portable external device.

[0127] According to one embodiment, the at least one instruction to the implantable medical device may include an instruction to change an operational state of the implantable medical device.

[0128] The wireless transceiver may be configured to wirelessly communicate with an external device using electromagnetic waves at frequencies below 100 kHz or frequencies below 40 kHz.

[0129] According to one embodiment, the wireless transceiver is configured to communicate wirelessly with the external device using a first communication protocol, and the central device is configured to communicate with the security module using a second, different communication protocol.

[0130] In any of the embodiments, the wireless transceiver may be configured to wirelessly communicate with the external device using a standard network protocol, which may be selected from the list consisting of an RFID-type protocol, a WLAN-type protocol, a Bluetooth-type protocol, a BLE-type protocol, an NFC-type protocol, a 3G / 4G / 5G-type protocol, and a GSM-type protocol.

[0131] The wireless transceiver, in some embodiments, is configured to wirelessly communicate with external devices using a proprietary network protocol.

[0132] According to one embodiment, the wireless transceiver comprises a UWB transceiver.

[0133] According to one embodiment, the security module and / or the central unit and / or the radio transceiver are configured in the controller.

[0134] The external unit in any of the embodiments herein may be a wearable device or a handset. An advantage of this embodiment is that the device is mobile and can be used wherever needed.

[0135] The implantable medical device may further include a receiving unit comprising: at least one coil configured to receive transcutaneously transmitted energy; a measurement unit configured to measure a parameter related to the energy received by the coil; a variable impedance electrically connected to the coil; and a switch disposed between the variable impedance and the coil to turn off the electrical connection between the variable impedance and the coil. The implantable medical device further comprises a controller configured to control at least one of the variable impedance to vary the impedance and thereby adjust the coil based on the measured parameter and the switch to turn off the electrical connection between the variable impedance and the coil in response to the measured parameter exceeding a threshold.

[0136] According to one embodiment, the controller is configured to vary the variable impedance in response when the measured parameter exceeds a threshold value.

[0137] According to one embodiment, the measurement unit is configured to measure a parameter related to the energy received by the coil over a period of time.

[0138] According to one embodiment, the measurement unit is configured to measure a parameter related to the change in energy received by the coil.

[0139] According to one embodiment, a first switch is located at a first end of the coil, and the implantable medical device further includes a second switch located at a second end of the coil so that the coil can be completely disconnected from other parts of the implantable medical device.

[0140] According to one embodiment, the receiving unit is configured to receive the transcutaneously delivered energy in pulses according to a pulse pattern, and the measuring unit is configured to measure a parameter related to the pulse pattern.

[0141] According to one embodiment, the controller is configured to control the variable impedance in response to deviations of the pulse pattern from a predefined pulse pattern.

[0142] According to one embodiment, the controller is configured to control a switch to turn off an electrical connection between the variable impedance and the coil in response to the pulse pattern deviating from a predefined pulse pattern.

[0143] According to one embodiment, the measurement unit is configured to measure a temperature within the implantable medical device or within the patient's body, and the controller is configured to control the first and second switches in response to the measured temperature.

[0144] According to one embodiment, the variable impedance is comprised of a resistor and a capacitor, a resistor and an inductor, and / or an inductor and a capacitor.

[0145] The variable impedance may be comprised of a digitally tuned capacitor. The variable impedance may be comprised of a digital potentiometer. The variable impedance may be comprised of a variable inductor.

[0146] According to one embodiment, the variation in impedance is configured to reduce the effective power received by the receiving unit.

[0147] According to one embodiment, a variable impedance is placed in series with the coil.

[0148] According to one embodiment, the variable impedance is placed in parallel with the coil.

[0149] According to one embodiment, the implantable medical device further comprises an energy storage unit connected to the receiving unit, the energy storage unit configured to store the energy received by the receiving unit.

[0150] As previously mentioned, such systems are particularly useful for use in valves such as artificial sphincters. Thus, according to another aspect of the present disclosure, an artificial sphincter, when implanted, can comprise a system as described herein, configured to act on the patient's intestinal wall to restrict the flow of intestinal contents out of the intestine.

[0151] Similarly, such systems are particularly useful for use in cavitation devices. Thus, according to another aspect of the present disclosure, a cavitation device may comprise a system as described herein that, when implanted, acts on the patient's intestinal wall to propel intestinal contents contained therein out of the intestine.

[0152] transplant Accordingly, a method of implanting a system for treating a patient having a bowel-related disorder comprises the following steps: - making an incision in the patient's body to access the intestine; wherein each of the one or more electrical stimulation devices comprises one or more electrodes for electrically stimulating intestinal muscle or nerve tissue and a wireless energy receiver configured to wirelessly receive energy for stimulating the muscle or nerve tissue; - connecting one or more electrodes of an electrical stimulator to the intestine, -inserting one or more wireless energy transmitters; - positioning one or more wireless energy transmitters in proximity to one or more electrical stimulation devices to enable transfer of energy from the one or more energy transmitters to all of the one or more electrical stimulation devices;

[0153] The method of implanting the system may include further steps as described above and in more detail below.

[0154] A method of using the system, artificial sphincter, or jejunal device accordingly comprises wirelessly transmitting energy to an energy receiver and receiving the energy by the energy receiver. The method of using the system may include further steps as described above and in more detail below.

[0155] Surface Coating A further aspect of the present disclosure relates to mitigating fibrin formation caused by contact of a medical implant, such as the implantable system described above, with a patient's tissues or flowing blood. As is well known, the body tends to react to medical implants, in part because the implant is a foreign body, in part because the implant mechanically interacts with the body's tissues and / or the blood flowing through the body. Implanting a medical device and / or biomaterial into a patient's tissue can trigger a foreign body response, leading to the formation of foreign body giant cells and the development of a fibrous capsule surrounding the implant. The formation of a dense fibrous capsule that isolates the implant from the host is a common underlying cause of implant failure. The implantation of a medical device and / or biomaterial in the bloodstream can also cause the formation of a fibrous capsule due to the attraction of certain cells in the bloodstream. Implants can cause blood clots due to fibrin formation, potentially leading to complications for the patient. Implants that come into contact with blood or remain in the body can also cause bacterial infections. One common method of combating blood clot formation is the use of various types of blood thinners. One commonly used blood thinner is heparin, but heparin has undesirable side effects.

[0156] Generally, fibrin is an insoluble protein produced in part in response to bleeding and is the main component of blood clots. Fibrin is formed from fibrinogen, a soluble protein produced in the liver and present in plasma. When bleeding occurs due to tissue injury, fibrinogen is converted to fibrin at the wound site by the action of the clotting enzyme thrombin. Fibrin, together with platelets, forms a hemostatic plug or clot at the wound site. The process of fibrinogenesis from fibrinogen first attracts platelets. Platelets have thrombin receptors on their surface that bind to serum thrombin molecules. These molecules convert soluble fibrinogen to fibrin. Fibrin then forms long chains of tough, insoluble protein bound to platelets. Fibrin then crosslinks, hardens, and contracts. This is made possible by factor XIII, an enzyme present in human blood. Fibrin is also produced in the foreign body response. When a foreign substance is detected in the body, the immune system is attracted to it and attempts to break it down. If this degradation is not successful, fibroblasts produce an envelope, which forms a physical barrier to isolate the body from the foreign body. This can further develop into a fibrin sheath. If the foreign body is an implant, this can interfere with the function of the implant.

[0157] Thus, when implants are implanted in the body, they may come into contact with flowing blood. This can lead to platelets adhering to the implant's surface. Platelets can then convert fibrinogen in the blood into fibrin, forming a sheath on and / or around the implant. This can cause the implant to malfunction and potentially lead to blood clots that are dangerous to the patient. However, even implants that do not come into contact with blood can malfunction due to fibrin formation. In this case, a foreign body reaction may be the underlying cause of the malfunction. Furthermore, the implantation of a foreign body into the human body can trigger an inflammatory response. This response generally persists until the foreign body is encapsulated in a relatively dense layer of fibrous connective tissue that protects the body from foreign bodies. This process may begin with the implant spontaneously acquiring a layer of host proteins. A surface modified with blood proteins allows cells to adhere to the surface and allows monocytes and macrophages to interact with the implant surface. Macrophages secrete proteins that regulate fibrosis and form a fibrotic capsule around the foreign body, i.e., the implant. In reality, the fibrous capsule can form a dense layer of excess fibrous connective tissue, whose inelastic properties can lead to hardening, tightening, deformation, and distortion of the implant, potentially leading to reoperation.

[0158] Implants can also cause various types of infections. Bacterial colonization leading to implant-related infections is a known problem with many types of implants. For example, Staphylococcus aureus and Staphylococcus aureus, which are normal skin bacteria, tend to colonize foreign bodies like implants and can cause infections. The problem with Staphylococcus aureus is that it forms a biofilm around the implant, sealing off the bacterial niche from the external environment. This makes it difficult for the host's defense system to deal with the bacteria. There are other examples of bacteria and processes that cause implant-related infections.

[0159] Thus, according to this further aspect of the present disclosure, to mitigate fibrin formation caused by contact between the components of the implantable system and the patient's tissue or flowing blood, the implantable components of the system may include a specific coating disposed on the outer surface of each of the components. This coating may be composed of at least one layer of a biomaterial, preferably a fibrin-based material. The coating may include at least one drug or substance with antithrombotic, antibacterial, and / or antiplatelet properties. The drug or substance may be encapsulated in a porous material.

[0160] A second coating may be provided on the first coating. The second coating may be a different biological material from the first coating. In particular, the first coating may consist of a perfluorocarbon layer chemically attached to the surface, and the second coating may consist of a liquid perfluorocarbon layer.

[0161] More preferably, the surface may be comprised of a metal such as at least one of titanium, cobalt, nickel, copper, zinc, zirconium, molybdenum, tin or lead.

[0162] Finally, the surface may include a micropattern, which may be etched into the surface prior to insertion into the body. A layer of biomaterial may be coated onto the micropattern.

[0163] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed system for treating a patient having a disorder related to the patient's bowel, the medical device being configured to be held in place by a tissue portion of the patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side; the second portion having a second cross-sectional area in a second plane and a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a second portion configured to be positioned through an opening in the tissue portion extending between the first side and the second side of the tissue portion. the connecting portion having a third cross-sectional area in a third plane and configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the first cross-sectional area and the second cross-sectional area to prevent the first portion and the second portion from moving through an opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the connecting portion and the second portion configured to form a connecting interface between the connecting portion and the second portion, wherein the second portion extends along a first direction parallel to the second plane, the second portion having a longitudinal cross-sectional area along the first direction, the second longitudinal cross-sectional area being smaller than the first longitudinal cross-sectional area, and the first longitudinal cross-sectional area being located closer to the connecting interface with respect to the first direction.

[0164] In some embodiments, the second portion has a first end and a second end opposite the first end along the first direction, the second portion has a length between the first end and the second end, the second portion has an intermediate region and a distal region, the intermediate region is defined by a connection interface between the connecting portion and the second portion, and the distal region extends from the connection interface between the connecting portion and the second portion to the second end.

[0165] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the second end.

[0166] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the second end.

[0167] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the second end.

[0168] In some embodiments, the distal region of the second portion is conical.

[0169] In some embodiments, the second portion has rotational symmetry along the first direction.

[0170] In some embodiments, the second surface of the second portion is substantially perpendicular to the central extension of the connecting portion.

[0171] In some embodiments, the second surface of the second portion is substantially parallel to the second plane.

[0172] In some embodiments, the second surface of the second portion is substantially flat and configured to form a contact area against the second tissue surface, and the second portion further comprises a lower surface facing away from the first portion configured to taper toward the second end.

[0173] In some embodiments, the second portion has a proximal region that extends from the first end to a connection interface between the connecting portion and the second portion.

[0174] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases continuously from the end of the midregion toward the first end.

[0175] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases linearly from the end of the midregion to the first end.

[0176] In some embodiments, the longitudinal cross-sectional area of ​​the second portion decreases gradually from the end of the midregion toward the first end.

[0177] In some embodiments, the proximal region of the second portion is conical.

[0178] In some embodiments, the first end and the second end each comprise an elliptical point.

[0179] In some embodiments, the first and second ends each comprise a hemispherical end cap.

[0180] In some embodiments, the second portion has at least one circular cross-section along its length between the first end and the second end.

[0181] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0182] In some embodiments, the second portion has at least one oval cross-section along its length between the first end and the second end.

[0183] In some embodiments, the second portion has said length in a different direction than the central extension of the connecting portion.

[0184] In some embodiments, the coupling interface between the coupling portion and the second portion is eccentric relative to the second portion.

[0185] In some embodiments, the connection interface between the connecting portion and the second portion is eccentric relative to the second portion in a first direction but not in a second direction perpendicular to the first direction.

[0186] In some embodiments, the connection interface between the connection portion and the second portion is off-center relative to the second portion in a first direction and in a second direction perpendicular to the first direction.

[0187] In some embodiments, the second direction is parallel to a second plane.

[0188] In some embodiments, the proximal and distal regions comprise a second surface configured to engage a second surface of a second side of the tissue portion.

[0189] In some embodiments, the second portion tapers from the first end to the second end.

[0190] In some embodiments, the second portion tapers from an intermediate region of the second portion to each of the first and second ends.

[0191] In some embodiments, the first portion has a maximum dimension in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0192] In some embodiments, the first portion has a diameter in the range of 10 to 40 mm, such as in the range of 10 to 30 mm, for example in the range of 15 to 25 mm.

[0193] In some embodiments, the connecting portion has a maximum dimension in the third plane in the range of 2 to 20 mm, such as in the range of 2 to 15 mm, for example in the range of 5 to 10 mm.

[0194] In some embodiments, the second portion has a maximum dimension in the range of 30 to 90 mm, such as in the range of 30 to 70 mm, for example in the range of 35 to 60 mm.

[0195] In some embodiments, the first portion has one or more of a spherical shape, an ellipsoidal shape, a polyhedral shape, an elongated shape, and a flattened disk shape.

[0196] In some embodiments, the connecting portion has one of an oval cross-section, an elongated cross-section, and a circular cross-section in a plane parallel to the third plane.

[0197] In some embodiments, the distal region is configured to face downward in a standing patient.

[0198] In some embodiments, the first portion has a first height and the second portion has a second height, both heights being in a direction perpendicular to the first and second planes, and the first height being less than the second height.

[0199] In some embodiments, the first height is less than 2 / 3 of the second height, such as less than 1 / 2 of the second height, such as less than 1 / 3 of the second height.

[0200] In some embodiments, the second end of the second portion comprises a connection portion for connecting to an implant located caudally from the location of the implantable, energized medical device within the patient.

[0201] In some embodiments, the first end of the second portion comprises a connection portion for connecting to an implant located cranially from the location of the implantable, energized medical device within the patient.

[0202] In some embodiments, the connecting portion further comprises a fourth cross-sectional area in a fourth plane, the fourth plane being parallel to the first, second and third planes, and the third cross-sectional area being smaller than the fourth cross-sectional area.

[0203] In some embodiments, the connecting portion comprises a protruding element defining a fourth cross-sectional area.

[0204] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0205] In some embodiments, the first portion comprises a first wireless energy receiver configured to receive wirelessly transmitted energy from an external wireless energy transmitter.

[0206] In some embodiments, the first portion comprises an internal wireless energy transmitter.

[0207] In some embodiments, the second portion comprises a second wireless energy receiver.

[0208] In some embodiments, the first portion comprises a first energy storage unit.

[0209] In some embodiments, the second portion comprises a second energy storage unit.

[0210] In some embodiments, at least one of the first and second energy storage units is a solid-state battery.

[0211] In some embodiments, the solid state battery is a thionyl chloride battery.

[0212] In some embodiments, the first wireless energy receiver is configured to receive energy wirelessly transmitted by the external wireless energy transmitter and store the received energy in the first energy storage unit, the internal wireless energy transmitter is configured to wirelessly transmit the energy stored in the first energy storage unit to the second wireless energy receiver, and the second wireless energy receiver is configured to receive the energy wirelessly transmitted by the internal wireless energy transmitter and store the received energy in the second energy storage unit.

[0213] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0214] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0215] In some embodiments, at least one of the first and second controllers is connected to a wireless transceiver for wireless communication with an external device.

[0216] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion.

[0217] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion.

[0218] In some embodiments, the first wireless energy receiver comprises a first coil and the internal wireless energy transmitter comprises a second coil.

[0219] In some embodiments, the first portion comprises a composite coil configured to wirelessly receive energy from an external wireless energy transmitter and wirelessly transmit energy to a second wireless receiver in the second portion.

[0220] In some embodiments, at least one of the coils is embedded in a ceramic material.

[0221] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the first portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0222] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0223] In some embodiments, the implantable energized medical device further comprises a housing configured to surround at least the second portion, the first portion of the housing being made from titanium and the second portion of the housing being made from a ceramic material.

[0224] In some embodiments, the portion of the housing made from a ceramic material includes at least one coil embedded in the ceramic material.

[0225] In some embodiments, the second portion comprises at least part of a manipulation device for manipulating the implantable body engaging portion.

[0226] In some embodiments, the second portion comprises at least one electric motor.

[0227] In some embodiments, the second portion comprises a transmission configured to reduce the speed and increase the force of the motion produced by the electric motor.

[0228] In some embodiments, the transmission is configured to transfer a weak force at a high speed to a strong force at a low speed.

[0229] In some embodiments, the transmission is configured to convert rotational force into linear force.

[0230] In some embodiments, the transmission comprises a gear system.

[0231] In some embodiments, the second portion comprises a magnetic coupling for transmitting mechanical work from the electric motor through one of a barrier separating a first chamber of the second portion from a second chamber of the second portion, a housing surrounding at least the second portion.

[0232] In some embodiments, the second part comprises at least one hydraulic pump.

[0233] In some embodiments, the hydraulic pump comprises a pump including at least one compressible hydraulic reservoir.

[0234] In some embodiments, the implantable energized medical device further comprises a capacitor connected to at least one of the first and second energy storage units and connected to the electric motor, the capacitor being configured to be charged by at least one of the first and second energy storage units and to provide power to the electric motor.

[0235] In some embodiments, at least one of the first and second portions comprises a sensation generator adapted to generate a sensation detectable by the patient's senses.

[0236] In some embodiments, the second portion comprises a force transmission element configured to mechanically transmit force from the second portion to the implant engaging portion.

[0237] In some embodiments, the second portion includes a force transmission element configured to hydraulically transmit force from the second portion to the implant engaging portion.

[0238] In some embodiments, the second portion comprises at least one lead for transmitting electrical energy and / or information from the second portion to the implanted body engaging portion.

[0239] In some embodiments, the first portion comprises an injection port for injecting a fluid into the first portion.

[0240] In some embodiments, the connecting portion comprises a conduit for transferring fluid from the first portion to the second portion.

[0241] In some embodiments, the conduit is positioned to extend through the hollow portion of the connecting portion.

[0242] In some embodiments, the second portion comprises a first chamber and a second chamber spaced apart from one another, the first chamber containing a first liquid and the second chamber containing a second liquid, the second liquid being a hydraulic liquid configured to transmit a force to the implantable element configured to exert a force on a body part of the patient.

[0243] In some embodiments, the walls of the first chamber are elastic to allow for expansion of the first chamber.

[0244] In some embodiments, the second portion comprises a first hydraulic system in fluid communication with a first hydraulically actuable implant element configured to exert a force on the patient's body part and a second hydraulic system in fluid communication with a second hydraulically actuable implant element configured to exert a force on the patient's body part, wherein the first and second hydraulically actuable implant elements are adjustable independently of one another.

[0245] In some embodiments, the first hydraulic system comprises a first hydraulic pump and the second hydraulic system comprises a second hydraulic pump.

[0246] In some embodiments, each of the first and second hydraulic systems includes a reservoir for holding hydraulic fluid.

[0247] In some embodiments, the implantable energized medical device further comprises a first pressure sensor configured to sense a pressure in the first hydraulic system and a second pressure sensor configured to sense a pressure in the second hydraulic system.

[0248] In some embodiments, the first surface is configured to engage a first tissue surface on a first side of the tissue portion.

[0249] In some embodiments, the first, second and third planes are parallel to the primary plane of extension of the tissue.

[0250] In some embodiments, the fourth plane is parallel to the primary plane of extension of the tissue.

[0251] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed systems for treating a patient having a disorder related to the patient's bowel, the medical device being configured to be held in place by a tissue portion of the patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connector configured to be positioned through an aperture in the tissue portion extending between the first side and the second side of the tissue portion. a connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface on a first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area such that the first portion, the second portion, and the connecting portion are prevented from moving through an opening in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; the first portion configured to receive electromagnetic waves at a frequency above a frequency level and / or to transmit electromagnetic waves at a frequency below a frequency level, and the second portion configured to receive and / or transmit electromagnetic waves at a frequency below a frequency level, the frequency level being 100 kHz.

[0252] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to the second portion.

[0253] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency above the frequency level to an external device.

[0254] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0255] In some embodiments, the electromagnetic waves comprise wireless energy and / or radio communications.

[0256] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter at a higher frequency level and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion at a lower frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter at the lower frequency level.

[0257] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0258] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0259] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communications from an external device above the frequency level, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communications to a second wireless communication receiver in the second portion below the frequency level.

[0260] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion at or below the frequency level.

[0261] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0262] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0263] In some embodiments, the second portion comprises an outer casing made of titanium.

[0264] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0265] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed system for treating a patient having a disorder related to the patient's bowel, the medical device being configured to be held in place by a tissue portion of the patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion. a connecting portion configured to be positioned through a hole in the tissue portion extending between the first and second sides of the portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface on the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter the first plane, the second plane, and the third plane are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, such that the first portion, the second portion, and the connecting portion are prevented from moving through the hole in the tissue portion in a direction perpendicular to the first plane, the second plane, and the third plane; and the first portion configured to receive and / or transmit electromagnetic waves at a frequency less than a frequency level, wherein the frequency level is 100 kHz.

[0266] In some embodiments, the second portion is configured to receive and / or transmit electromagnetic waves at a frequency below the frequency level.

[0267] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency equal to or less than the frequency level to the second portion.

[0268] In some embodiments, the first portion is configured to transmit electromagnetic waves at a frequency below the frequency level to an external device.

[0269] In some embodiments, the frequency level is 40 kHz or 20 kHz.

[0270] In some embodiments, the electromagnetic waves comprise wireless energy and / or radio communications.

[0271] In some embodiments, the first portion comprises a first wireless energy receiver for receiving energy wirelessly transmitted by an external wireless energy transmitter below a frequency level, and an internal wireless energy transmitter configured to wirelessly transmit energy to the second portion below a frequency level, and the second portion comprises a second wireless energy receiver configured to receive energy wirelessly transmitted by the internal wireless energy transmitter below a frequency level.

[0272] In some embodiments, the first portion comprises a first controller including at least one processing unit.

[0273] In some embodiments, the second portion comprises a second controller including at least one processing unit.

[0274] In some embodiments, the first controller is connected to a first wireless communication receiver in the first portion for receiving wireless communication from an external device at a frequency level below, and the first controller is connected to a first wireless communication transmitter in the first portion for transmitting wireless communication to a second wireless communication receiver in the second portion at a frequency level below.

[0275] In some embodiments, the second controller is connected to a second wireless communication receiver for receiving wireless communication from the first portion at or below the frequency level.

[0276] In some embodiments, the first portion comprises an outer casing made from a polymeric material.

[0277] In some embodiments, the first portion comprises a titanium outer casing.

[0278] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the first portion must pass through the casing.

[0279] In some embodiments, the second portion comprises an outer casing made of titanium.

[0280] In some embodiments, the outer casing forms the complete enclosure, and the electromagnetic waves received and transmitted by the second portion must pass through the casing.

[0281] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed systems for treating a patient having a disorder related to the patient's bowel, the medical device being configured to be held in place by a tissue portion of the patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; and a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in a second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion. a connecting portion configured to be positioned through an opening in the tissue portion extending between the first portion and the second side portion, the connecting portion having a third cross-sectional area in a third plane and comprising a third surface configured to engage a first tissue surface of the first side of the tissue portion, the connecting portion configured to connect the first portion to the second portion, wherein hereinafter the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, so as to prevent movement of the first portion, second portion, and connecting portion through the opening in the tissue portion in a direction perpendicular to the first, second, and third planes, the first portion being made from a polymeric material and the second portion being comprised of a casing made from titanium, the casing forming a complete housing.

[0282] In some embodiments, the casing of the second part forms a complete enclosure when the second part is connected to the connecting part, such that the entire outer surface of the second part is covered by the casing.

[0283] In some embodiments, the first portion comprises a casing made from a polymeric material.

[0284] In some embodiments, the casing of the first part forms a complete enclosure such that the entire outer surface of the first part is covered by the casing.

[0285] In some embodiments, the connecting portion comprises a connector that connects to each of the first and second portions and is arranged to transmit electrical signals and / or energy.

[0286] In some embodiments, the joint is disposed in the joint core such that it is sealed by the outer material of the joint.

[0287] In some embodiments, the coupling portion comprises a ceramic material.

[0288] In some embodiments, the connections are encapsulated in a ceramic material.

[0289] In some embodiments, the first portion comprises a first connecting portion configured to connect to a connecting portion of the connecting portion.

[0290] In some embodiments, the second portion comprises a second connecting portion configured to connect to the connecting portion of the connecting portion.

[0291] In some embodiments, the casing of the second part is hermetically sealed.

[0292] In some embodiments, the second connection is positioned such that the hermetic seal of the second portion remains intact.

[0293] In some embodiments, the casing of the first portion is sealed.

[0294] A further aspect of the present disclosure relates to an implantable, energized medical device that may be advantageously combined with the disclosed systems for treating a patient having a disorder related to the patient's bowel, the medical device being configured to be held in place by a tissue portion of the patient, the medical device comprising: a first portion configured to be positioned on a first side of the tissue portion, the first portion having a first cross-sectional area in a first plane and comprising a first surface configured to face a first tissue surface on the first side of the tissue portion; a second portion configured to be positioned on a second side of the tissue portion, the second side facing the first side, the second portion having a second cross-sectional area in the second plane and comprising a second surface configured to engage a second tissue surface on the second side of the tissue portion; and a connecting portion configured to be positioned through an aperture in the tissue portion extending between the first and second sides of the tissue portion, the connecting portion having a third cross-sectional area in a third plane and comprising a second surface configured to engage a second tissue surface on the first side of the tissue portion. a connecting portion having a third surface configured to engage a first tissue surface of the first portion, the connecting portion configured to connect the first portion to the second portion, wherein the first, second, and third planes are parallel to one another and the third cross-sectional area is smaller than the second cross-sectional area, preventing the first, second, and connecting portions from moving through holes in the tissue portions in directions perpendicular to the first, second, and third planes; the connecting portion is configured to extend between the first and second portions along a central extension axis, and the second portion is configured to extend in a lengthwise direction diverging from the central extension axis; the connecting portion has a substantially constant cross-sectional area along the central extension axis or the connecting portion has a cross-sectional area that decreases in a direction from the first portion to the second portion along the central extension axis, and / or the second portion has a substantially constant cross-sectional area along the lengthwise direction or the second portion has a cross-sectional area that decreases in the lengthwise direction.

[0295] In some embodiments, the third cross-sectional area is smaller than the first cross-sectional area.

[0296] In some embodiments, the connecting portion tapers along the central extension axis in a direction from the first portion to the second portion.

[0297] In some embodiments, the connecting portion has a circular or elliptical cross-section along the central elongate axis that decreases in diameter in a direction from the first portion to the second portion.

[0298] In some embodiments, the second portion is tapered in its length.

[0299] In some embodiments, the connecting portion has a circular or elliptical cross section that decreases in diameter along its length.

[0300] In some embodiments, the length direction extends from the interface between the connecting portion and the second portion toward an end of the second portion.

[0301] In some embodiments, the length direction extends substantially perpendicular to the central elongation axis.

[0302] In accordance with one embodiment of the present concept, an implantable device for exerting a force on a body part of a patient is provided, the implantable device comprising an implantable energized medical device and an implantable element configured to exert a force on the body part of the patient.

[0303] In some embodiments, the implantable element configured to exert a force on a body part of a patient is an implantable hydraulic constrictor.

[0304] In some embodiments, the implantable hydraulic constriction device is configured to constrict the patient's intestines.

[0305] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the colon or rectum of a patient.

[0306] In some embodiments, the implantable hydraulic constriction device comprises an implantable hydraulic constriction device for constricting the intestine in the region of the patient's stoma. [Brief explanation of the drawings]

[0307] The invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1A] FIG. 1A illustrates a top view of a first embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 1B] FIG. 1B shows the system of FIG. 1A in a side view—partial cross-section. [Figure 1C] FIG. 1C shows another side view of the system of FIG. 1A. [Figure 2A] FIG. 2A illustrates a top view of a second embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 2B] FIG. 2B shows the system of FIG. 2A in a side view—partial cross-section. [Figure 3A] FIG. 3A illustrates a top view of a third embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 3B] FIG. 3B shows the system of FIG. 3A in a side view—partial cross-section. [Figure 4A] FIG. 4A illustrates a top view of a fourth embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 4B] FIG. 4B shows the system of FIG. 4A in a side view—partial cross-section. [Figure 5A] FIG. 5A illustrates a top view of a fifth embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 5B] FIG. 5B shows the system of FIG. 5A in a side view—partial cross-section. [Figure 5C] FIG. 5C shows a side view—partial cross-section—of a variation of the system of FIG. 5A. [Figure 6] FIG. 6 illustrates a top view of a sixth embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 7]FIG. 7 illustrates a top view of a seventh embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 8] FIG. 8 illustrates, in top view, an eighth embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 9] FIG. 9 illustrates a top view of a ninth embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 10A] FIG. 10A shows in top view a hydraulic pump system that may be provided to support any one of the embodiments of a system for electrically stimulating a patient's intestinal tissue described herein. [Figure 10B] FIG. 10B shows the system of FIG. 10A in a partial cross-sectional side view. [Figure 11] FIG. 11 illustrates, in top view, an eleventh embodiment of a system for electrically stimulating intestinal tissue of a patient. [Figure 12A] FIG. 12A shows various examples of electrode placements for electrically stimulating muscle tissue of a patient. [Figure 12B] FIG. 12B shows various examples of electrode placements for electrically stimulating a patient's muscle tissue. [Figure 12C] FIG. 12C shows various examples of electrode placements for electrically stimulating a patient's muscle tissue. [Figure 12D] FIG. 12D shows various examples of electrode placements for electrically stimulating a patient's muscle tissue. [Figure 13] FIG. 13 shows a pulse signal for electrically stimulating muscle tissue. [Figure 14] FIG. 14 shows a pulse signal for electrically stimulating muscle tissue. [Figure 15] FIG. 15 is a schematic diagram of a system for treating reflux disease. [Figure 16] FIG. 16 is a schematic diagram of a system for treating reflux disease. [Figure 17] FIG. 17 is a schematic diagram of a system for treating reflux disease. [Figure 18] FIG. 18 is a flow chart of a method for porting the system. [Figure 19A] FIG. 19A generally illustrates a system for communicating with an implanted medical device. [Figure 19B] FIG. 19B generally illustrates a system for communicating with an implanted medical device. [Figure 19B] FIG. 19B' generally illustrates a system for communicating with an implanted medical device. [Figure 19C] FIG. 19C generally illustrates a system for communicating with an implanted medical device. [Figure 20] FIG. 20 illustrates one embodiment of a system for charging, programming, and communicating with a controller of an implantable medical device. [Figure 21] FIG. 21 is an elevated perspective view from the left side of the housing unit. [Figure 22] FIG. 22 is a plan view of the housing as seen from the left. [Figure 23] FIG. 23 is an elevated perspective view from the left side of the housing unit. [Figure 24] FIG. 24 is a plan view of the housing as seen from the left. [Figure 25] FIG. 25 shows an outline of a system of an external device consisting of a housing unit that wirelessly communicates with an implantable medical device and a display device. [Figure 26] FIG. 26 shows an implant having an implant surface and a coating disposed on the surface. [Figure 27] FIG. 27 shows an implant with multiple coatings on the implant surface. [Figure 28A] FIG. 28A shows different micropatterns applied to the surface of the implant. [Figure 28B] FIG. 28B shows different micropatterns applied to the surface of the implant. [Figure 29] FIG. 29 shows one embodiment of an implantable energized medical device. [Figure 30] FIG. 30 shows one embodiment of an implantable energized medical device. [Figure 31A] FIG. 31A shows the first portion and connecting portion of the medical device of FIGS. [Figure 31B] FIG. 31B shows the first portion and connecting portion of the medical device of FIGS. [Figure 31C] FIG. 31C shows the first portion and connecting portion of the medical device of FIGS. [Figure 31D] FIG. 31D shows the first portion and connecting portion of the medical device of FIGS. [Figure 32A] FIG. 32A shows a modified example of the elements of the connecting portion of FIGS. 31A to 31C. [Figure 32B] FIG. 32B shows a modified example of the elements of the connecting portion of FIGS. 31A to 31C. [Figure 33A] FIG. 33A shows a modified example of the elements of the connecting portion of FIGS. 31A to 31C. [Figure 33B] FIG. 33B shows a modified example of the elements of the connecting portion of FIGS. 31A to 31C. [Figure 34A] FIG. 34A shows a modified example of the elements of the connecting portion of FIGS. 31A to 31C. [Figure 34B] FIG. 34B shows a modified example of the elements of the connecting portion of FIGS. 31A to 31C. [Figure 35] FIG. 35 shows a kit for assembling the medical device of FIGS. [Figure 36] FIG. 36 shows a further embodiment of an implantable energized medical device. [Figure 37] Figure 37 shows a typical example of an implantable energized medical device. [Figure 38] FIG. 38 shows a first variant of the general embodiment of the medical device of FIG. [Figure 39] FIG. 39 shows a second variation of the general embodiment of the medical device of FIG. [Figure 40A] FIG. 40A shows a cross section of the medical device of FIG. [Figure 40B] FIG. 40B shows a cross section of the medical device of FIG. [Figure 41A] FIG. 41A illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41B] FIG. 41B illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41C] FIG. 41C illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41D] FIG. 41D illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41E] FIG. 41E illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41F] FIG. 41F illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41G] 41G illustrates a different relative arrangement of the first and second components of the medical device of FIG. 37. [Figure 41H] FIG. 41H illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41I] FIG. 41I illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41J] FIG. 41J illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41K] FIG. 41K illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41M] FIG. 41M illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41N] FIG. 41N illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41P] FIG. 41P illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 41Q] FIG. 41Q illustrates a different relative arrangement of the first and second components of the medical device of FIG. [Figure 42] FIG. 42 shows a third variant of the general embodiment of the medical device of FIG. [Figure 43] FIG. 43 shows a third variant of the general embodiment of the medical device of FIG. [Figure 44] FIG. 44 shows the medical device of FIG. 37 with its first and second portions at different rotational displacements relative to one another. [Figure 45] FIG. 45 shows the medical device of FIG. 37 with its first and second portions at different rotational displacements relative to one another. [Figure 46A] FIG. 46A illustrates the procedure for inserting the medical device of FIGS. [Figure 46B] FIG. 46B illustrates the procedure for inserting the medical device of FIGS. [Figure 46C] FIG. 46C illustrates the procedure for inserting the medical device of FIGS. [Figure 47] FIG. 47 shows a further embodiment of an implantable energized medical device. [Figure 48A] FIG. 48A shows a gear arrangement and magnetic coupling for coupling an implantable energized medical device to an implant. [Figure 48B] FIG. 48B shows a gear arrangement and magnetic coupling for coupling an implantable energized medical device to an implant. [Figure 49A] FIG. 49A is a right perspective elevation view of one embodiment of an implantable energized medical device for powering an implantable medical device. [Figure 49B] FIG. 49B shows a longitudinal cross-section of the implantable medical device along line AA of FIG. 49A. [Figure 49C] FIG. 49C shows a longitudinal cross-section of the implantable medical device along line AA of FIG. 49A. [Figure 50] FIG. 50 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device; [Figure 51] FIG. 51 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device; [Figure 52]FIG. 52 is a cross-sectional plan side view of an embodiment of an implantable energized medical device for powering an implantable medical device; [Figure 53A] FIG. 53A is a perspective elevation view from the right side of one embodiment of an implantable energized medical device for powering an implantable medical device; [Figure 53B] FIG. 53B shows a longitudinal cross section of the implantable medical device along line AA in FIG. 53A. [Figure 53C] FIG. 53C shows a longitudinal cross section of the implantable medical device along line AA in FIG. 53A. DETAILED DESCRIPTION OF THE INVENTION

[0308] Detailed Description Hereinafter, a detailed description of embodiments of the present invention will be provided with reference to the accompanying drawings. It will be understood that the drawings are for illustrative purposes only and do not limit the scope of the present invention in any way. Accordingly, references to directions such as "up" and "down" merely refer to the directions shown in the drawings. It should be noted that features having the same reference numerals have the same functions, and therefore, features of one embodiment can be interchanged with features of another embodiment having the same reference numerals unless there is a clear contradiction. Therefore, descriptions of features having the same reference numerals should be considered to complement each other in explaining the basic idea of ​​the features, thereby demonstrating the versatility of the features.

[0309] Intestinal restriction is understood to be any operation that reduces the cross-sectional area of ​​the intestine. The restriction may reduce the flow of substances through the intestine or may result in a complete closure of the intestine so that substances cannot pass through. Contraction is understood to be any restriction by a special method of restricting the intestine, i.e., by contraction using, for example, a mechanical or hydraulic contraction device that acts on the intestine from the outside, causing it to contract.

[0310] A controller is understood as any unit capable of controlling at least part of the system. The controller may include a motor and / or a pump, or any other actuation device for operating at least part of the system. It may be separate from the electrical stimulation device and / or the mechanical or hydraulic contraction device and may be adapted to control only their operation. Preferably, the controller includes a CPU that enables the controller to process data. A control signal is understood as any signal capable of transmitting information and / or power so as to be able to directly or indirectly control the electrical stimulation device and / or the mechanical or hydraulic contraction device, or other parts of the system.

[0311] 1A is a top view of a first embodiment of a system for treating a patient having a disorder related to the patient's intestine 100. In this and following embodiments, the system is adapted to be implanted in association with a reservoir portion of intestine 100 formed from surgically altered intestine cut along a line of mutual contact of laterally adjacent portions of a bent section of intestine, with the upper and lower halves of the cut intestine connected to form the intestinal wall of the reservoir portion. The connecting line is sutured with sutures 101.

[0312] The system for treating a patient's intestine includes electrical stimulation using multiple electrical stimulators 10. Each electrical stimulator 10 can be composed of one or more electrodes 11. In the illustrated embodiment, the electrical stimulator 10 is composed of seven electrodes 11. The electrodes 11 of each electrical stimulator 10 may be interconnected by electrical wires 12, meaning that when a voltage is applied to the wires 12, the electrodes 11 are simultaneously energized. In the illustrated embodiment, the electrical wires 12 to which the electrodes 11 are connected are positioned along the interconnection line where the upper and lower halves of the cut intestine are sewn together by sutures 101. Alternatively, the electrodes 11 may be positioned at different locations on the intestine 100.

[0313] Each of the electrical stimulation devices 10 includes a wireless energy receiver R configured to receive energy for wirelessly stimulating muscle or nerve tissue in the intestine 100. Thus, the electrical stimulation devices 100 are not physically interconnected and are independent of one another. As can be seen from the side view shown in FIG. 1B, the electrical stimulation device 10 includes two branches 10A, 10B that share a common wireless energy receiver R. As can be seen from another view shown in FIG. 1C, the electrodes 11 can be positioned in the surgically created plication 102 with or without electrical wires 12. Alternatively, the electrodes 11 and / or electrical wires 12 can be attached to the outer wall 103 of the intestine 100, as shown in FIG. 1B, or embedded in the wall 103 (not shown).

[0314] In the embodiment shown in FIGS. 1A-1C, a wireless energy transmitter T is provided for each wireless energy receiver R, thereby wirelessly transmitting energy to the electrical stimulation device 10, thereby making the electrical stimulation device 10 relatively independent not only from each other but also from the rest of the overall system. In this way, the electrical stimulation device 10 remains relatively flexible over time, minimizing the risk of loss of flexibility due to fibrosis growing over and enveloping the system. This is important for the proper function of the intestine, which must be able to perform filling and emptying movements, particularly peristalsis. This applies not only to intestinal reservoirs, such as those shown in the modified version of FIG. 1, but also to the normal intestine, to which the system disclosed herein is similarly applicable. However, care must be taken that the wireless energy transmitter T is located, or more specifically, implanted, sufficiently close to the wireless energy receiver R to allow safe transmission of energy from the energy transmitter T to each associated energy receiver R.

[0315] Energy transfer between the wireless energy transmitter T and the wireless energy receiver R is preferably via cooperating antennas, such as respective primary coils of the transmitter T and respective secondary coils of the receiver R, the primary coils being configured to induce voltages in the associated secondary coils, so that the wireless energy transmitter and receiver are preferably positioned in close proximity to each other when implanted.

[0316] The primary and secondary coils of a wireless transmitter T and receiver R allow energy to be transferred from the energy transmitter to the energy receiver using RFID technology. This technology is well established. In particular, the wireless energy receiver R can be configured to receive energy via RFID pulses.

[0317] On the other hand, the wireless energy transmitters T do not necessarily need to remain flexible over time and are therefore each connected to a controller via electrical wiring 13. The controllers are designated C, which represents an "external" controller, as compared to an internal controller that may form part of the electrical stimulation device 10, as will be described later in this specification. I More specifically, the external controller C II is an implanted external controller, where the implantation is under the skin so that it can be manually activated by a switch 14, which may have the form of a press button. In particular, the switch 14 can be implanted subcutaneously as shown in FIG. 1A, or it can be provided outside the patient's body on the patient's skin (as shown in FIG. 6).

[0318] Furthermore, the rechargeable energy storage unit E is connected to an external controller C II an external controller C to provide energy to the wireless energy transmitter T when appropriately controlled by II1A , the energy storage unit E is wirelessly rechargeable through the patient's skin 200, as shown by the arrow, and therefore the energy storage unit E is preferably implanted in close proximity to the patient's skin 200. Alternatively, as shown in FIG. 6 , the energy storage unit E may be connected by wire to a port 15 attached to the patient's skin 200. Whenever needed, the energy storage unit E can be recharged by docking an electrical charger to the port 15.

[0319] Thus, when the system is implanted by a patient or caregiver, it can be activated by pressing a switch 14 implanted under the skin 200, which activates the controller C. II starts, and controller C II The program installed in the CPU of the controller C is executed according to the program. I The energy storage unit E sequentially releases energy to the electrical stimulation device 10. As a result, different parts of the intestine 100 are electrically stimulated at different times, causing them to contract, thereby restricting the volume within the intestine 100. In this way, the intestinal contents contained within the intestine 100 are pushed further and further within the intestine 100 towards the end of the intestine 100. At the end of the program, the energy transfer between the wireless energy transmitter T and the receiver R is terminated so that the nerve and muscle tissue of the intestine 100 relaxes. Of course, the external controller C II The execution of the program in can be interrupted at any time, if necessary, by activating switch 14 again.

[0320] 2A shows a top view of a second embodiment of a system for electrically stimulating a patient's intestinal tissue. This embodiment differs from the first embodiment in that each electrical stimulation device 10 includes only a single electrode 11. Accordingly, each electrical stimulation device 10 has its own wireless energy receiver R, and therefore a wireless energy transmitter T is provided for each electrical stimulation device 10. The wireless energy transmitters T may be arranged on a common web 16, which may preferably have a net-like structure with one wireless energy transmitter T attached to an associated connection point of the net-like structure.

[0321] Figure 2B shows the system of Figure 2A in side view, including two of the aforementioned webs 16, referenced in Figure 2B as webs 16A and 16B, similar to branches 10A and 10B of Figure 1B. As can be seen in both Figures 2A and 2B, wireless energy transmitters T overlap their associated wireless energy receivers R by a minimal distance to provide the best energy transfer between wireless energy transmitters T and receivers R.

[0322] Figure 3A is a top view of a third embodiment of a system for electrically stimulating a patient's intestinal tissue. Figure 3B is a side view of the third embodiment. This embodiment differs from the first embodiment shown in Figures 1A-1C in that a single wireless energy transmitter T is provided to transmit energy to all of the electrical stimulation devices 10. Since it is not desirable to energize all of the electrical stimulation devices 10 simultaneously, each electrical stimulation device 10 is provided with an internal controller C. I An internal controller C Icontrols a switch 17 that respectively interrupts and closes the electrical connection between the associated wireless energy receiver R and the electrode or electrodes 11 of the respective electrical stimulation device 10. Thus, the wireless energy transmitter T is adapted to not only transmit energy but also transmit data to the wireless energy receiver R, and similarly, the wireless energy receiver R is adapted to not only wirelessly receive energy but also receive data. For this purpose, RFID technology is particularly suitable, since, as is well known in the art, RFID signals can be used to transmit both energy and information. Therefore, the internal controller C communicates with the wireless energy receiver R via the wireless energy receiver R. I The data wirelessly received by includes information regarding when to close and / or open switch 17 so that energy is transmitted to a corresponding electrical stimulation device 10 via wireless energy receiver R. The transmission of energy on the one hand and data on the other hand between wireless energy transmitter T and wireless energy receiver R is indicated by different arrows in Figures 3A and 3B, respectively.

[0323] More specifically, the internal controller C of each of the plurality of electrical stimulation devices 10 I are the internal controllers C I Use a unique individual code to connect the external controller C II As mentioned above, in situations where the electrical stimulators are activated sequentially to stimulate the intestine in waves, each electrical stimulator may be individually addressed by a corresponding internal controller C I In this way, the specifically addressed internal controller C I, can be activated by closing the associated switch 17, such that only this particular electrical stimulation device 10 receives electrical energy via the wireless energy transmitter T for stimulating its respective portion of the intestine 100. Thus, the wireless energy transmitter T can consist of a single primary coil that extends across the entire secondary coils of the wireless energy receivers R of all of the electrical stimulation devices 10.

[0324] 4A and 4B show a fourth embodiment of a system for electrically stimulating a patient's intestinal tissue in top and side views, respectively. This embodiment differs from the third embodiment only in that each electrical stimulator 10 comprises its own energy storage unit E, which may be, for example, a rechargeable battery or a capacitor. Thus, the energy storage unit E of the electrical stimulator 10 is connected to an internal controller C. I is connected to an external controller C via a (common) wireless energy transmitter T. II The external controller C may store energy over time so that sufficient energy is available at each of the electrical stimulators 10 when it receives instructions from the external controller C to close and therefore activate the associated stimulator 10. II The energy storage unit E connected to is preferably a rechargeable battery capable of storing large amounts of energy for long periods of time, whereas the energy storage unit E of the electrical stimulation device 10 is preferably configured as a capacitor that is substantially small, almost negligible in size, and capable of storing sufficient energy for the shorter but still sufficiently long period of time required for the process of stimulating the intestine 100.

[0325] Of course, the wireless energy receiver R in the first and second embodiments shown in FIGS. 1A, 1B, 2A, and 2B also includes a wireless energy receiver R, an internal controller C, I , and an energy storage unit E, preferably in the form of a capacitor.

[0326] 5A and 5B show a fifth embodiment of a system for electrically stimulating a patient's intestinal tissue in top and side views, respectively. This embodiment combines the second and third embodiments shown in FIGS. 2A and 2B with those shown in FIGS. 3A and 3B in that, on the one hand, each electrical stimulator 10 is composed of a single electrode 11 (as in the second embodiment), and, on the other hand, a single wireless energy transmitter T is provided to supply energy to all electrical stimulators 10 (as in the third embodiment). Each electrical stimulator 10 therefore includes an internal controller C in addition to a wireless energy receiver R. I Includes an internal controller C I can be individually addressed to activate a switch (similar to switch 17 in Figures 3A and 3B, but not shown in Figures 5A and 5B) so that stimulation of the intestine 100 can be achieved by the corresponding electrical stimulation device 10.

[0327] The primary coil 18 of the wireless energy transmitter T is shown in Figures 5A and 5B as overlaying multiple electrical stimulation devices 10. Because energy transfer from the primary coil 18 to the electrical stimulation devices 10 on the lower side of the intestine 100 is less efficient than energy transfer to the electrical stimulation devices 10 on the upper side of the intestine 100, a preferred embodiment consists of two wireless energy transmitters T, each with a primary coil 18A and 18B, one positioned to overlay the electrical stimulation devices 10 on the upper side of the intestine 100 and the other positioned to overlay the electrical stimulation devices 10 on the lower side of the intestine 100, as shown in Figure 5C. Thus, in the embodiment shown in Figure 5C, each of the wireless energy transmitters T transmits energy to multiple (but not all) of the electrical stimulation devices 10.

[0328] Of course, the electrical stimulation device 10 in the embodiment of Figures 5A-5C may further include an energy storage unit E, similar to that described above in relation to the fourth embodiment shown in Figures 4A and 4B.

[0329] In the above-described embodiment, the energy is transferred to the external controller C II, external controller C II is wirelessly transmitted to the energy storage unit E connected to the external controller C II is activated by a switch 14, such as a push button. However, as already mentioned above and as shown in Figure 6, which represents a sixth embodiment, a port 15 may be provided external to the patient's body, e.g., attached to the patient's skin 200, by which an external energy source may be connected to recharge the energy storage unit E, and / or a switch, e.g., a push button, may be located external to the patient's body, e.g., on the patient's skin 200. Alternatively, the energy storage unit E may be omitted and a separate energy source may be attached to the port 15, either permanently or whenever electrical stimulation of the intestine 100 by the system is desired.

[0330] 7, which represents a seventh embodiment, an energy storage unit E may be attached to the patient's skin 200, the energy storage unit E preferably being a rechargeable or at least replaceable battery, but may be other types of energy storage unit as well. The embodiment shown in FIG. 7 includes an external controller C II 7 further differs from the previous embodiments in that it is not implanted but is located outside the patient's body, here attached to the patient's skin 200. The embodiment shown in FIG. 7 has most features in common with the first embodiment described above in relation to FIGS. 1A and 1B, but other embodiments also include an external controller C that is / is located outside the patient's body, preferably on the patient's skin. II and / or external controller C II It is clear that the power supply may also comprise an energy storage unit E connected to

[0331] FIG. 8 shows an eighth embodiment, which differs from the seventh embodiment, in that the patient or caregiver controls the external controller C. II Remote controller C that can communicate wirelessly with R Of course, it also has an external controller in the form of a wireless external controller C IIAs shown in the first to sixth embodiments above, the implanted external controller C II This may be preferable for the patient. For example, the remote controller C R , can form part of a program or app on a remote device such as a mobile phone, a watch, or another mobile device, making application of the system very convenient for users and caregivers.

[0332] In a ninth preferred embodiment, an external controller C, which may be implanted or worn on the patient's skin, is used, as shown in FIG. II , is omitted, and the embedded wireless energy transmitter T is controlled by a wireless remote controller C R Remote Controller C R Since the wireless remote controller C performs wireless communication, R an additional wireless energy receiver R to receive control signals from the T is provided for implantation. An additional wireless energy receiver R T and the wireless energy transmitter T may, in some cases, be combined to form a transceiver. Otherwise, the functionality of the tenth embodiment of FIG. 9 is identical to that described above in connection with the other embodiments. In particular, the particular embodiment shown in FIG. 9 includes a wireless energy receiver R and an internal controller C. I The electrical stimulation device 10 may further include an energy storage device E and an internal controller C. I The electrical stimulation device 10 may be configured with only a wireless energy receiver R without an internal controller C. I , the system must include a wireless energy transmitter T for each of the electrical stimulators 10, similar to the first embodiment shown in FIGS. 1A and 1C, and the electrical stimulators 10 must be connected to a remote controller C. RFor each wireless energy transmitter T, an additional wireless energy receiver R can be individually addressed by T It is necessary to set up

[0333] The system for electrically stimulating the patient's intestinal tissue as described above may be combined with a mechanical or hydraulic contraction device, such as that disclosed in WO 2011 / 128124 A1. Particularly preferred are hydraulic contraction devices, such as those shown in FIGS. 10A and 10B, or hydraulic contraction devices. Such a contraction device may act on the same portion of the patient's intestine as the electrical stimulation device. In particular, such a contraction device may form part of a pump configured to propel intestinal contents downstream through the patient's intestine, and in this context may cooperate with the electrical stimulation device 10.

[0334] In this context, FIGS. 10A and 10B show a tenth embodiment of a hydraulic pump comprising a hydraulically acting member 190 adapted to act externally on the intestinal wall of a reservoir 140, the reservoir 140 corresponding to the intestine 100 shown in the previous embodiment. The hydraulically acting member 190 is connected to an artificial reservoir 193 that supplies hydraulic fluid to the hydraulically acting member 190. The artificial reservoir 193 is large enough to accommodate a volume of hydraulic fluid corresponding to the volume of the intestinal reservoir 140. The artificial reservoir 193 has flexible walls that allow hydraulic fluid to be drawn from and refilled into the artificial reservoir 193. The hydraulically acting member 190 is made of a flexible material and may be tubular or bag-like to accommodate the intestinal reservoir 140 containing the electrical stimulation device 10 (not shown) therein. As shown in FIG. 5B, the reservoir 140 is surrounded by the hydraulically acting member 190. The hydraulically acting member 190 is divided into a number of chambers, the first chamber 191 and the last chamber 194 of which are connected by hydraulic conduits to an artificial reservoir 193. The chambers are interconnected via connections 192 which may be simple holes acting as throttles or may include one or more valves which are preferably automatically controlled.

[0335] When the patient activates the system using the subcutaneous actuator 14, hydraulic fluid is supplied from the artificial reservoir 193 to the first chamber 191, thereby initiating the emptying of the intestinal reservoir 140. Subsequent chambers are supplied with hydraulic fluid through connection 192, causing the hydraulic actuation member 190 to slowly fill from the first chamber 191 to the last chamber 194. The chambers fill sequentially, with each chamber beginning to fill before the previous chamber is fully filled. In this manner, the intestinal contents are hydraulically squeezed out in a direction toward the outlet of the reservoir 140. When the hydraulic actuation member 190 is completely filled with hydraulic fluid, the reservoir 140 is fully deflated. Hydraulic fluid is then drawn back into the artificial reservoir 193 from the chambers of the hydraulic actuation member 190 using negative pressure. The intestinal reservoir 140 then begins to fill again with intestinal contents.

[0336] This process is controlled by a device 150 connected to the artificial reservoir 193. Connected to or integrally formed with the artificial reservoir 193 is an electrically driven pump (not shown) for pumping hydraulic fluid to and withdrawing hydraulic fluid from the hydraulically actuated members. The electrically driven pump is supplied with energy from a combined energy storage means and controller 145. The combined energy storage means and controller 145 is connected to an external controller C as described above in connection with the electrically stimulated system. E , and may further include an energy storage unit E. Also, as described above, the wireless remote controller C R It is also possible to provide:

[0337] In another embodiment, each chamber of the hydraulically actuated member 190 may have a separate fluid connection to the artificial reservoir 193 so that they can be filled individually. The intestinal reservoir 140 can be emptied by sequentially filling two adjacent chambers of the hydraulically actuated member 190, i.e., first filling the first and second chambers, then emptying the first chamber while filling the third chamber, then emptying the second chamber while filling the fourth chamber, etc. In this way, the intestinal contents are squeezed towards and expelled from the outlet of the intestinal reservoir 140.

[0338] Alternatively, instead of applying negative pressure to evacuate the chamber, at least one valve, preferably two valves (not shown) may be provided between the hydraulically acting member 190 and the artificial reservoir 193 which, when in a suitable operating position, allows passive flow of hydraulic fluid from the hydraulically acting member back to the artificial reservoir 193 when the intestinal reservoir 140 is filled with intestinal contents, and which, when in another suitable position, prevents flow of hydraulic fluid from the hydraulically acting member back to the artificial reservoir when the intestinal reservoir is emptied.

[0339] The wirelessly controllable electrical stimulation device 10 described above can similarly be implemented in a valve for temporarily restricting or closing an intestinal passageway, with or without an additional constriction device, such as a hydraulic constriction device. In other words, a system including the wirelessly controllable electrical stimulation device described above can be used in a valve, such as an artificial sphincter. Such a valve or artificial sphincter can be used as an outlet and / or inlet valve for an intestinal reservoir, such as a reservoir created from the patient's intestine or an artificial reservoir described above. This is further described in connection with an eleventh embodiment of a system for electrically stimulating intestinal tissue of a patient, as shown in the top view of FIG. 11. This embodiment differs from the third embodiment shown in FIG. 3A in that an outlet valve 40 is provided adjacent to the patient's colon or rectum or stoma, and an inlet valve 30 is provided upstream of it. However, such an outlet valve 40 and / or inlet valve 30 can similarly be provided in any of the other embodiments described herein. While both the outlet valve 40 and the inlet valve 30 are shown in an open configuration in FIG. 11 , typically, one of the two valves is closed and the other is open. Each closed state can be achieved by electrically stimulating nerve or muscle tissue in the intestine 100 adjacent to the electrode 11 of the corresponding electrical stimulator 10. While the electrical stimulators 10 of the outlet and inlet valves 40, 30 are shown with a single electrode 11, they may be comprised of multiple electrodes, such as two, three, or four, preferably on opposing sides of each intestinal section. The electrical stimulator 10 of the outlet valve 40 includes a wireless energy transmitter T on top of a wireless energy receiver R of the electrical stimulator 10. EX Meanwhile, the electrical stimulation device 10 of the inlet valve 30 is connected to a wireless energy transmitter T on an associated wireless energy receiver R. EN Wireless Energy Transmitter T EX , T EN Both are external controllers C E Therefore, stimulation of each part of the intestine 100 is controlled by an external controller C E , from the energy storage unit E to the wireless energy transmitter T EX , TEN This can be achieved by transmitting energy to a wireless energy receiver R via

[0340] In addition to the electrical stimulation device 10, both the outlet valve 40 and the inlet valve 30 may be equipped with hydraulic constrictors, which may also be controlled by an external controller C. E The electrical stimulation and hydraulic contraction can be coordinated by the hydraulic contraction device. The hydraulic contraction device comprises hollow hydraulic members 41 and 31, respectively, a hydraulic pump P, and an energy storage device E, which may be the same energy storage device that supplies energy to the electrical stimulation device 10. In particular, a single energy storage device E may be provided for the entire system. The hydraulic pump P is configured to pump hydraulic fluid into the hollow hydraulic members 41 and 31, respectively, and to withdraw hydraulic fluid from the hollow hydraulic members 41 and 31. FIG. 11 shows a state in which hydraulic fluid is withdrawn from the hollow hydraulic members 31 and 41, and in this case, the respective intestinal segments are not contracted. When the hollow hydraulic members are filled with hydraulic fluid, the intestinal segments contract to an extent that the passage of intestinal contents is prevented (not shown). Of course, instead of a hydraulic throttle device, the outlet valve 40 and / or the inlet valve 30 may be configured as a mechanical throttle device that serves the same purpose.

[0341] In embodiments of the present disclosure, where the system includes a mechanical or hydraulic constriction device and is configured to electrically stimulate, via one or more electrodes, muscle or nerve tissue in the region of the intestine constricted by the mechanical or hydraulic constriction device, such electrical stimulation can simply increase blood flow through the intestinal tissue without causing the intestine to contract, or can constrict the tissue only partially without completely restricting flow through the respective intestinal section. The purpose is to mobilize the tissue wall in contact with the constriction device, whether mechanical or hydraulic. That is, the body tends to react to medical implants both because the implant is a foreign body and because the implant mechanically interacts with the body's tissue. Exposing tissue to prolonged engagement and pressure with a mechanical, hydraulic, or other type of constriction device can deprive tissue cells of oxygen and nutrients, leading to tissue deterioration, atrophy, and ultimately necrosis. This can result in device migration, including penetration through the tissue wall. Stimulating blood flow and mobilizing tissue cells increases the tissue's resistance to pressure from the implant. As previously mentioned, the system is preferably configured so that electrical stimulation of muscle or nerve tissue to increase blood flow through the intestinal tissue is adjustable at a low level that is not sufficient to cause the intestines to contract.

[0342] Transplantation Method FIG. 19 is a flowchart of a method for implanting a system, including the following steps: - making an incision in the patient's body to access the intestine; wherein each of the electrical stimulation devices comprises one or more electrodes for electrically stimulating muscle or nerve tissue of the intestine, and a wireless energy receiver configured to wirelessly receive energy for stimulating the muscle or nerve tissue; -implanting at least the electrodes of an electrical stimulation device into a surgically created fold in the patient's intestine; -inserting one or more wireless energy transmitters; - positioning a wireless energy transmitter in the vicinity of the electrical stimulation devices to enable the transfer of energy from the energy transmitter to all of the electrical stimulation devices, which may consist of inserting a separate wireless energy transmitter for each one of the electrical stimulation devices to enable the transfer of energy to each one of the electrical stimulation devices; - wherein the electrical stimulation device comprises an internal controller and optionally an external controller implanted separate from the internal controller, the external controller and the internal controller configured to communicate wirelessly; Optionally, at least one mechanical or hydraulic contraction device is implanted outside the patient's intestine to contract the intestine from outside the intestine.

[0343] The step of placing electrodes of the electrical stimulator in connection with the intestine includes placing at least two of the electrodes of the electrical stimulator on opposite sides of the patient's intestine.

[0344] Electrical stimulation / electrodes The electrode placements described below can be implemented in any of the embodiments of the present disclosure, particularly for the purpose of motivating intestinal tissue walls in contact with a constriction device, such as a mechanical or hydraulic constriction device. Human and animal bodies tend to react to medical implants, in part because the implants are foreign bodies and in part because the implants mechanically interact with bodily tissue. Prolonged engagement of tissue with or pressure from an implant can deprive cells of oxygen and nutrients, causing tissue deterioration, atrophy, and ultimately necrosis. As previously discussed, this can result in device migration, including migration through the tissue wall. Implant-tissue interaction can also result in fibrosis, in which the implant is at least partially encased in fibrous tissue. Therefore, it is desirable to stimulate or motivate cells to promote blood flow and increase tissue resistance to pressure from the implant.

[0345] Muscle tissue generally consists of muscle cells bound together by tissues that become myofibrils or smooth muscle, depending on the presence or absence of organized, regularly repeating sequences of myofibrillar contractile proteins called myofilaments. Muscle tissue is further classified into skeletal and cardiac muscle tissue. Skeletal muscle tissue is typically under conscious control and is anchored to bones by tendons. Cardiac muscle tissue is typically found in the heart and is not subject to voluntary control. The third type of muscle tissue is so-called smooth muscle tissue, which is typically neither muscular nor under voluntary control. Smooth muscle tissue constitutes the muscular portion of the digestive tract and lining of the lining of the intestines.

[0346] Muscle contraction is activated by the interaction of the nervous system and hormones, and different muscle types and regions respond differently to neurotransmitters and endocrine substances.

[0347] Nerves are bundles of nerve fibers called axons, which are extensions of individual nerve cells, or neurons. Axons are electrically excitable by maintaining a voltage gradient across their membrane, providing a common pathway for electrochemical nerve impulses called action potentials. Action potentials are all-or-nothing electrochemical pulses generated by axons when the voltage across the axon's membrane changes sufficiently large over a short interval. Action potentials travel from one neuron to another by crossing synapses, where messages are converted from electrical to chemical and back again.

[0348] The distal end of the axon, called the axon terminal, contains synaptic vesicles that store neurotransmitters. The axon terminal is specialized to release neurotransmitters into the interface, or junction, between the axon and the muscle cell. The released neurotransmitters briefly bind to receptors on the muscle cell membrane and are then dissociated and hydrolyzed by enzymes within the synapse. These enzymes rapidly reduce the impulse to the muscle, allowing the magnitude and timing of muscle contraction to be carefully regulated.

[0349] The action potential of a normal skeletal muscle cell is similar to that of a neuron and is typically approximately -90 mV. Upon activation, sodium / potassium channels in the cell membrane open, allowing sodium to enter and potassium to exit. As a result, the cell membrane reverses polarity, and as sodium enters, the cell membrane voltage jumps rapidly from a resting membrane potential of -90 mV to +75 mV. The muscle action potential lasts approximately 2-4 ms, has an absolute refractory period of approximately 1-3 ms, and has a conduction velocity along the muscle of approximately 5 m / s. This change in polarity, in turn, causes the muscle cell to contract.

[0350] The contractile activity of smooth muscle cells is typically influenced by multiple inputs, including spontaneous electrical activity, neural and hormonal inputs, local changes in chemical composition, and stretch. In contrast, the contractile activity of skeletal and cardiac muscle cells depends on a single neural input. Some smooth muscle cell types can spontaneously generate action potentials, which are typically followed by pacemaker and slow-wave potentials. However, the rate and strength of contraction can be regulated by external input from the autonomic nervous system. Autonomic neurons may organize into a series of axon-like bulges called varicosities that form motor units throughout smooth muscle tissue. Vesicles are composed of neurotransmitter-containing vesicles that transmit signals to muscle cells.

[0351] The aforementioned muscle cells, namely cardiac, skeletal, and smooth muscle cells, are known to respond to external stimuli, such as electrical stimulation by electrodes. A distinction can be made between nerve-mediated stimulation and direct electrical stimulation of muscle tissue. In nerve-mediated stimulation, the electrical signal can be delivered to nerves at locations distant from the actual muscle tissue, or it can be delivered at the muscle tissue, depending on the accessibility and extensibility of the nerves in the body. In direct stimulation of muscle tissue, the electrical signal is delivered to the muscle cells by electrodes placed directly or in close contact with the muscle cells. However, other tissues, such as fibrous tissue or nerves, may also be present at the interface between the electrode and the muscle tissue, resulting in electrical stimulation of these other tissues.

[0352] In the context of this application, the electrical stimulation discussed in connection with various aspects and embodiments can be provided to tissue in direct or indirect contact with the implantable constriction device. Preferably, the electrical stimulation is provided by one or more electrode elements disposed on or within the tissue, or at the interface or contact between the implantable constriction device and the tissue. Therefore, in the context of this disclosure, electrical stimulation can be considered a direct stimulation of the tissue, particularly in contrast to stimulation transmitted over distance by nerves, which is referred to as indirect stimulation or neural stimulation.

[0353] Thus, an electrode arrangement consisting of one or more electrode elements can be placed in, part of, on, or near the tissue to be moved by the electrical signal. Preferably, the electrode is capable of transmitting an electrical signal to the portion of the tissue to be stimulated to cause the tissue to contract, or to move with no or little contraction. Thus, when implanted, the electrode element can be considered to be placed between the medical implant, such as a contraction device, and the tissue against which the implant is placed so as to rest.

[0354] During electrical stimulation, electrical signals can cause muscle cells to contract and relax. When this activity is low, this cellular behavior, known as motility, can have a positive effect in preventing tissue degradation and damage. Furthermore, this motility may help tissues withstand pressure and mechanical forces generated by medical implants.

[0355] The interaction between the electrodes of an electrical stimulator and the patient's intestinal tissue is largely determined by the properties of the junction between the tissue and the electrode element. The active, electrically conductive surface of the electrode element (hereafter referred to as "metal," although other materials are equally possible) is either uncoated, resulting in a metal-tissue interface, or insulated with some type of dielectric material. The uncoated metal surface of an electrode is sometimes referred to as a bare electrode. The interface between the electrode and tissue can affect the behavior of the electrode, as electrical interactions with the tissue are transmitted through this interface. In the biological medium surrounding the electrode, including actual tissue and electrolytes that may be present at the junction, current is carried by charged ions, while in the electrode material, current is carried by electrons. Therefore, some mechanism is required to transfer charge between these two carriers to allow continuous current flow.

[0356] In some embodiments, the electrode is bare, exposing the metal to the surrounding biological medium when implanted in the muscle or nerve tissue to be stimulated. In this case, charge transfer can occur at the metal-electrolyte interface between the electrode and the tissue. A voltage is applied across the interface, attracting and ordering ions from the electrolyte as a natural thermodynamic equilibrium between the metal and the electrolyte occurs. This layer of charged ions on the metal surface is called the "double layer," and it physically accounts for part of the electrode's capacitance.

[0357] Thus, both capacitive and faradaic processes can occur at an electrode. In a faradaic process, the movement of charged particles across the metal-electrolyte interface is considered to be the primary mechanism for current transfer. Thus, in a faradaic process, the charge, voltage, and composition of the electrode tend to a constant value after a constant current is applied. Instead, in a capacitive (non-faradaic) process, charge gradually accumulates on the metal surface, and current transfer is generally limited to the amount that can pass by charging the interface.

[0358] In some instances, the electrode may be comprised of 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 and the tissue when the electrode element is implanted. This allows electrical signals to be transmitted to the tissue primarily via a faradaic charge transfer process. Because the faradaic process tends to be more efficient than the capacitive charge transfer process, bare electrodes may be advantageous from the perspective of power consumption. Therefore, the use of bare electrodes can increase the current transmitted to the tissue for a given power consumption.

[0359] In some instances, electrodes may include a portion at least partially covered with a dielectric material to form a dielectric-tissue interface with muscle tissue when the electrode is implanted. This type of electrode allows for primarily capacitive, i.e., non-Faradic, transmission of electrical signals to muscle tissue. This may be advantageous over the primarily Faradaic processes associated with bare electrodes, as Faradaic charge transfer can be associated with several problems. Examples of problems associated with Faradaic charge transfer include undesirable chemical reactions such as metal oxidation, water electrolysis, saline oxidation, and organic oxidation. Water electrolysis generates gases, which can be damaging. Saline oxidation can produce various compounds, some of which are toxic. Metal oxidation can release metal ions and salts into the tissue, which can be dangerous. Finally, organic oxidation in situations where the electrode element is directly stimulating tissue can produce toxic chemical products.

[0360] This can be achieved by using electrodes at least partially covered with a dielectric material, preferably chosen to have as high a capacitance as possible, to restrict the current flowing across the interface primarily capacitively.

[0361] The present disclosure allows for the combination of several types of electrode elements. The electrode element can be, for example, a plate electrode consisting of a plate-shaped active portion that forms an interface with tissue. In another example, the electrode can be a wire electrode formed of a conductive wire that can be in electrical contact with tissue. A further example is a needle- or pin-shaped electrode with a tip that can be attached to or inserted into muscle tissue. The electrode can be, for example, composed of a gold wire or contact pad for contacting muscle tissue, encased in epoxy resin for electrical insulation and protection.

[0362] It will be appreciated that both faradaic and capacitive mechanisms can exist simultaneously, regardless of the type of electrode used. Thus, capacitive charge transfer exists for bare electrodes forming a metal-tissue interface, and faradaic charge transfer exists for coated electrodes forming a dielectric-tissue interface. It has been found that shortening the pulse duration of the electrical signal can reduce or eliminate the faradaic portion of the current delivered to muscle tissue. Shortening the pulse duration has been found to be an efficient way to increase the portion of the signal that can pass through the interface as capacitive current, rather than faradaic current. As a result, shorter pulses can cause less damage to the electrode and tissue.

[0363] The capacitive portion of the current can be further increased relative to the faradaic portion by decreasing the amplitude of the current pulse of the electrical signal, which can reduce or inhibit chemical reactions at the electrode-tissue interface, thereby reducing potential damage caused by compounds and ions generated by such reactions.

[0364] As an example, electrical stimulation can be controlled such that a positive pulse of the electrical signal is followed by a negative pulse (or, stated differently, a pulse of one polarity followed by a second pulse of the opposite polarity), preferably of the same amplitude and / or duration. Advantageously, the subsequent negative (or reverse) pulse can be used to reverse, or at least moderate, the chemical reaction or changes that occur at the interface in response to the first positive pulse. Generating a reverse pulse can reduce the risk of electrode and / or tissue degradation at the electrode-muscle tissue interface.

[0365] Although FIG. 11 shows an embodiment in which the inlet / outlet valves 30, 40 each comprise a single electrode 11, multiple electrodes 11 may be provided to electrically stimulate the tissue of the intestinal tract to exercise the muscle tissue in order to improve the long-term implantation condition of the inlet / outlet valves 30, 40. In the embodiment of FIG. 11, the electrodes 11 are positioned below the hollow hydraulic members 31, 41 and are therefore positioned in electrical communication with the intestinal tissue. Alternatively, a first and optionally second electrode 11 may be positioned on a first side of the light organ, and a third and optionally fourth electrode 11 may be positioned on a second, opposing side of the intestine. Each of the four or four electrodes 11 may be connected to an external controller C for controlling the electrical stimulation of the intestinal tissue so that the intestinal tissue is stimulated by a series of electrical pulses. E (Instead, Wireless Remote Controller C R). The pulses may consist of a pulse of a first polarity followed by a pulse of a second polarity, and the generated pulsed electrical stimulation signal may have a pulse frequency of 0.01 to 150 Hz. The electrical stimulation signal may have a pulse duration of 0.01 to 100 ms and a pulse amplitude of 1 to 15 mA. More specifically, the electrical stimulation signal may have a pulse frequency of 0.15 to 0.25 Hz, a pulse duration of 20 to 30 ms, and a pulse amplitude of 3 to 10 mA. Furthermore, the electrical stimulation signal may have a build-up period of 0.01 to 2 seconds with gradually increasing amplitude, a stimulation period of 1 to 60 seconds, and a stimulation rest period of 0.01 to 60 seconds, and the electrical signal may have a pulse frequency of 1 to 50 Hz and a pulse duration of 0.1 to 10 ms.

[0366] FIG. 12A illustrates an example of a bipolar electrode arrangement 150, consisting of first and second electrode elements 152, 154, which may be configured similarly to the electrode elements described with reference to any of the previous embodiments. In the following figures, the first and second electrode elements are distinguished by the reference numerals E1 and E2, respectively. The first and second electrode elements E1, E2 may be connected to different electrical potentials. Thus, the first electrode element E1 may operate as an anode, and the second electrode element E2 may operate as a cathode. However, in alternative embodiments, both electrode elements E1, E2 may operate as cathodes, while body tissue is used as the anode. The electrode elements E1, E2 may be attached directly to the exterior of an implantable device, such as that disclosed with reference to FIG. 11. In some examples, the electrode elements E1, E2 may be disposed on a support, such as a flexible patch, which may be configured to be attached to the implantable constriction device 30. The electrode arrangement 150 can be positioned between the implantable constriction device 30 and the tissue (as disclosed with reference to FIG. 11 ) and in some embodiments can be provided as a separate, physically distinct item, while in other embodiments it can be incorporated into the device 100. The electrode arrangement 150 may include one or more contact pads to increase the contact surface between the electrode and the tissue when implanted. In operation, an electrical signal is supplied to the muscle tissue by the first and second electrode elements E1, E2 to stimulate contraction of muscle cells.

[0367] 12B shows another example of an electrode arrangement 150, which in this example may be unipolar electrode elements 152, 154. Electrode element E1, for example, may act as the cathode when implanted. Electrode element 152 may be formed of a flat, coiled wire to increase the contact surface between electrode element 152 and tissue. Furthermore, the coiled configuration allows for a certain degree of mechanical flexibility of electrode element 152 so that it can conform to muscle tissue during contraction and relaxation.

[0368] 12C shows a distal portion of a needle- or pin-shaped electrode arrangement 150, in which the active portion of the electrode element 152 protrudes from an insulator 156 covering the remainder of the electrode element 152 and is provided as a bare electrode surface 155 at the distal portion of the electrode element 152. Thus, when implanted in muscle tissue, the active bare electrode surface 155 of the electrode element 152 can form a metal-tissue interface with the muscle tissue, which can surround the end of the electrode element 152 to provide a relatively large contact surface. This embodiment is advantageous in that it can be inserted into tissue, thereby allowing selective stimulation at a certain depth of the tissue.

[0369] Figure 12D shows an electrode element 152 similar to that of Figure 12C, except that the electrode element 152 includes an active portion covered with a dielectric material 157 to protect the electrode material from degradation and to facilitate capacitive current transfer. The dielectric material 157 may be, for example, electrochemically deposited tantalum oxide, which allows charge to pass across the interface while reducing the risk of electrode corrosion, gas formation, and metabolic reactions.

[0370] It will be appreciated that both faradaic and capacitive mechanisms can exist simultaneously, regardless of the type of electrode used. Thus, capacitive charge transfer exists for bare electrodes that form a metal-tissue interface, and faradaic charge transfer exists for coated electrodes that form a dielectric-tissue interface. It has been found that shortening the pulse duration of an electrical signal can reduce or eliminate the faradaic portion of the current delivered to muscle tissue. Shortening the pulse duration has been found to be an efficient way to increase the portion of the signal that can pass through the interface as capacitive current, rather than faradaic current. As a result, shorter pulses can cause less damage to the electrode and tissue.

[0371] The capacitive portion of the current can be further increased relative to the faradaic portion by decreasing the amplitude of the current pulse of the electrical signal. Reducing the amplitude can reduce or inhibit chemical reactions at the electrode-tissue interface, thereby reducing potential damage caused by compounds and ions generated by such reactions. In one example, electrical stimulation can be controlled so that a positive pulse of the electrical signal is followed by a negative pulse (or, stated another way, a pulse of one polarity followed by a second pulse of the opposite polarity), preferably of the same amplitude and / or duration. Advantageously, the subsequent negative (or reverse) pulse can be used to reverse or at least moderate any chemical reactions or changes occurring at the interface in response to the first positive pulse. Generating a reverse pulse can reduce the risk of electrode and / or tissue degradation at the electrode-muscle tissue interface.

[0372] FIG. 13 illustrates an example of a pulsed electrical signal applied to electrodes for electrically stimulating muscle tissue through the electrode-tissue interface, as described above. The electrical signal can be generated by a stimulation controller located outside the body (as described with reference to FIG. 11) or by a stimulation controller implanted within the body. A stimulation controller 170 may be operatively connected to the electrode elements 152, 154 by leads 172, and the electrical signal shown in this figure may reflect either a signal generated by the stimulation controller 170 or a signal delivered to the electrode elements 152, 154 at the electrode-tissue interface. The characteristics of the electrical signal can be selected and varied based on the electrical properties of the electrode-tissue interface and the actual response of the tissue. The electrical stimulus provided to muscle cells may depend on several factors, including the configuration and placement of the electrode elements 152, 154 in the tissue, the presence of fibrous material at the interface, the composition of electrolytes at the interface, and the accumulation of non-conductive material on the electrode surface. Therefore, it is proposed to select and vary the characteristics of the electrical signal, such as those shown in this figure, based on the observed or estimated response from the stimulated tissue.

[0373] In this embodiment, the electrical signal is a pulse signal consisting of square waves PL1, PL2, PL3, and PL4. However, pulses of other shapes may be employed. The pulse signal may be periodic, as shown, or may be intermittent (i.e., a series of multiple pulses separated by periods without pulses). The pulses may have an amplitude A measured in volts, amperes, etc. Similarly, if the signal is periodic, the pulse signal has a period F corresponding to the frequency of the signal. Furthermore, the pulses may be either positive or negative relative to a reference.

[0374] The pulse frequency may be, for example, within the range of 0.01 to 150 Hz. More specifically, the pulse frequency may be within at least one of the ranges of 0.1 to 1 Hz, 1 to 10 Hz, 10 to 50 Hz, and 50 to 150 Hz. It has been observed that relatively low pulse frequencies can be employed to mimic or enhance the slow wave potentials associated with pacemaker cells in smooth muscle tissue. Therefore, for such applications, it may be advantageous to use relatively low pulse frequencies, such as 0.01 to 0.1 Hz, frequencies below 1 Hz, or even a few Hz.

[0375] The pulse duration can be, for example, 0.01 to 100 milliseconds (ms), e.g., 0.1 to 20 ms, preferably 1 to 5 ms. Some studies have observed that natural muscle action potentials are approximately 2 to 4 ms long, so it may be advantageous to use a pulse duration that mimics that range.

[0376] The amplitude may be in the range of 1 to 15 milliamperes (mA), with some studies showing particularly good muscle contraction responses in the range of 0.5 to 5 mA.

[0377] In a preferred embodiment, electrical stimulation is performed using a pulse signal with a pulse frequency of 10 Hz, a pulse duration of 3 ms, and an amplitude of 3 mA.

[0378] Figure 14 shows an example of a pulse signal, consisting of a build-up period X1, during which the amplitude gradually increases; a stimulation period X2, during which the muscle tissue is exposed to a contractile stimulation signal; a ramp-down period X3, during which the amplitude gradually decreases; and a rest period X4 before a new build-up period begins. The build-up period can be, for example, 0.01 to 2 seconds, the stimulation period 1 to 85 seconds, the ramp-down period 0.01 to 2 seconds, and the rest period 0.01 to 60 seconds. The pulse frequency can be, for example, 1 to 50 Hz, the pulse duration 0.1 to 10 milliseconds, and the amplitude during the stimulation period 1 to 15 milliamperes. Stimulation of skeletal muscle tissue can be performed using, for example, a 50 Hz pulse with a 100 μs duration. The current amplitude can be 1, 2.5, 7.5, or 10 mA. In particular, the desired muscle contractile response has been experimentally observed in the range of 0.5 to 5.0 mA. In this example, a coiled electrode can be used as the cathode. Another design example is a multi-stranded wire arranged in a helical configuration. These can be implanted into the muscle wall of the fundus (or esophagus) and stimulated in any desired pattern. Stimulation parameters can be, for example, biphasic pulses, 10-40 Hz, 0.1-5 ms duration, and a current density of 3-5 mA / cm.

[0379] 15 is a schematic diagram of a system for electrically stimulating or exercising muscle cells to increase the tissue's resistance to pressure from an instrument 100. The system can be used in conjunction with, and in some instances configured within, an implantable device 100. The system can be comprised of an electrode arrangement 150, which can be configured similarly to the electrode arrangements / electrode elements described above in connection with the previous examples, an energy source 160 for providing the electrical energy necessary to generate the electrical signal, and a stimulation controller 170 for controlling the generation of the electrical signal.

[0380] An electrode arrangement 150 consisting of one or several electrode elements 152, 154, such as a bare electrode or an electrode at least partially covered with a dielectric material 157 shown in FIG. 12D, can be configured to be implanted in or engage the muscle tissue to be stimulated to form an electrode-tissue interface through which a stimulation signal can be delivered. Alternatively, or additionally, the electrode elements 152, 154 can be positioned in proximity to the muscle tissue such that an electrical coupling is established between the electrode elements and the muscle tissue. This is the case, for example, when other tissue, such as connective tissue, exists between the implanted device and the muscle tissue.

[0381] The electrodes may be electrically connected to the energy source 160, for example by wires or leads, such that an electrical signal is transmitted to the electrode-tissue interface. In some examples, the electrodes 152, 154 may be integral with or attached to the device such that when implanted in a patient, the electrodes 152, 154 are positioned at the interface between the device 100 and muscle tissue. This allows the electrodes 152, 154 to be used to exercise muscle tissue that is mechanically influenced by the implant.

[0382] The energy source 160 may be a non-rechargeable type, such as a primary battery, or a rechargeable type, such as a secondary battery. The energy source 160 may be rechargeable from outside the body by energy transmitted from an external energy source, or may be surgically replaceable. Furthermore, the electrode arrangement 150 may be operatively connected to a stimulation controller 170, which may comprise an electrical pulse generator, to generate electrical pulses. The stimulation controller 170 may be integrated with the energy source 160, configured to be implanted within the body, or provided as a physically separate and distinct unit configured to operate from outside the body. In the latter case, it may be advantageous for the external control unit to be able to wirelessly communicate with the stimulation controller 150.

[0383] According to some embodiments, the system may include a sensor S1 configured to sense a physical parameter of the body and / or device 100. The sensor S1 may be employed to sense or detect a bodily response to an electrical stimulus, such as, for example, a contraction of stimulated muscle tissue. As an example, the sensor S1 may be configured to sense an action potential delivered to the muscle tissue. The action potential may be generated, for example, by pacemaker cells in the muscle tissue, and may be registered by the sensor S1 and transmitted to the stimulation controller 170. The stimulation controller 170 may use the received signal in controlling the energy source 160 such that the generated electrical signal amplifies the sensed action potential.

[0384] The energy source 160 may preferably be an implantable energy source 160 configured to be placed inside the patient's body. Preferably, the implantable energy source 160 may comprise a secondary battery that can be charged externally to reduce the need for surgical battery replacement procedures. As shown in the figure, the implantable energy source 160 may be configured to receive electrical energy from an external energy source 165 placed outside the body. In such an example, the system may further include an implantable charger 190 electrically connected to the implantable energy source 160 and configured to enable charging of the implantable energy source 160 by the external energy source 165. The implantable charger 190 may be configured to be electrically connected to the implantable energy source 160 by wiring or leads, for example, so that electrical energy can be transferred from the implantable charger 190 to the implantable energy source 160. The implantable charger 190 may further be coupled to the external energy source 165 by wireless or wired coupling using wiring or leads similar to those between the charger 190 and the implantable energy source 160. In the latter case, the wires or leads may terminate in terminals accessible through the patient's skin, for example, by making an incision in the skin to expose a port into which the external energy source 165 can be plugged, thereby connecting the external energy source 165 to the port to transfer electrical energy to the charger 190.

[0385] Alternatively, implantable charger 190 may be configured to receive energy wirelessly, e.g., inductively, from external energy source 165. In this case, charger 190 may include an electromagnetic coil configured to wirelessly receive power from external energy source 165. Charger 190 may be placed subcutaneously, for example, to facilitate inductive transfer of energy through the patient's skin.

[0386] Charging of implantable energy source 160 can be controlled according to several different schemes. In one example, charging of implantable energy source 160 can be controlled by controlling the reception of power from an external energy source at implantable charger 190. Stated differently, charger 190 may be configured to vary or control its ability to receive electrical energy from external energy source 165.

[0387] Thus, the amount of power supplied to implantable energy source 160 may be regulated at implantable charger 190 rather than at external energy source 165, which may therefore be allowed to transmit a substantially constant power. By varying the power received at charger 190 rather than the power transmitted at external energy source 165, charging of implantable energy source 160 may be performed without sending control signals to external energy source 165. Instead, the intelligence required to regulate and control the charging of implantable energy source 160 may be contained within the patient's body without the need for communication outside the body.

[0388] In alternative embodiments, charging of implantable energy source 160 may be controlled by controlling the transmission of power in external energy source 165. Thus, charger 190 (or any other component of the device / system placed inside the body) can send transmission commands, e.g., via control signals, to external energy source 165, which can adjust its transmission power accordingly.

[0389] Charging of implantable energy source 160 may be controlled by controller 170, which may therefore be configured to issue control commands to implantable charger 190 and / or external energy source 165, as described above. In some examples, controller 170 may be configured to indicate a functional status of implantable energy source 160, such as, for example, the charge level, charge capacity, voltage, and / or temperature of implantable energy source 160. The functional status may be used, for example, to control charging of implantable energy source 160, as described above, and to indicate the status of implantable energy source 160 to another external entity, such as the patient or medical staff. The functional status may be transmitted, for example, outside the body, interpreted there, and used to diagnose the condition / status of the implanted device. Additionally, the functional status may be transmitted outside the body to provide a warning signal, for example, indicating a low battery or overheating. Transmission of signals to / from controller 170 is described in further detail in connection with FIGS. 15-17 below.

[0390] The functional status may be based on signals from sensors, such as, for example, a temperature sensor configured to sense the temperature of the implanted energy source 160, or an ammeter or voltmeter configured to measure the electrical condition of the implanted energy source 160. The sensor output may be transmitted, for example, by wires or conductors, to the controller 170, where it may be processed and acted upon in the form of an issued signal containing control instructions and / or functional status information for the charger 190 / external energy source 165.

[0391] The functional status may in some instances be transmitted externally via a carrier signal by a transmitter that may be placed subcutaneously, for example, or may be built into the charger 190.

[0392] FIG. 16 illustrates a similar embodiment to the system described above with reference to FIG. 15 . However, as shown in this figure, the system may further include an external signal transmitter 175, such as a wireless remote 175, which may be configured to be operably connected to the controller 170. The external signal transmitter 175 may be positioned to allow the patient or another external entity, such as a service technician or medical staff, to interact with the controller 170. The external signal transmitter 175 may be used to control or adjust the operation of the implanted controller 170, for example, to affect or adjust the electrical stimulation signal delivered to tissue by the electrode arrangement 150. External control of the controller 170 may serve, for example, to increase or decrease the amplitude or frequency of the electrical stimulation signal or to activate / deactivate electrical stimulation. In one example, the external signal transmitter 175 may be used to increase electrical stimulation of a cardiac sphincter in response to experienced reflux symptoms. In this way, the patient may increase contraction of the cardiac sphincter to further prevent stomach contents from ascending in the esophagus.

[0393] The signal that the external signal transmitter 175 communicates with the embedded controller 170 may be selected from the group consisting of a sound signal, an ultrasonic signal, an electromagnetic wave signal, an infrared signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma ray radiation signal.

[0394] Although shown as separate components / entities in the figures, it is understood that the implantable or internal controller 170 may be integrated into the implantable charger 190 and / or the implantable energy source 160. Additionally, the external signal transmitter 175 may be integrated into the wireless remote device.

[0395] Figure 17 is a schematic diagram of a system, or apparatus, that may be configured similarly to the systems described with reference to Figures 15 and 16. Thus, a system is disclosed that includes an electrode arrangement 150 for exercising muscle tissue affected by an implanted device according to any of the embodiments described above in connection with Figures 1-11, and a controller 170 configured to be operatively connected to the electrode arrangement 150 for controlling electrical stimulation of the muscle tissue. The controller 170 may be coupled to an implantable energy source 160 for powering the electrode arrangement in accordance with a stimulation signal or pattern generated by the controller 170.

[0396] FIG. 17 further illustrates an implantable communicator 171, which may be configured to transmit signals between the controller 170 and outside the patient's body, similar to that described above in connection with FIG. 16. The communicator 171 may be integrated into the controller 170 or may be provided separately. Thus, the communicator 171 may be used to transmit signals configuring the functional status of the implantable energy source 160 and to communicate with an external controller 176 used to control or regulate the operation of the implantable controller 170. The external controller 176 may be configured, for example, as a remote controller 175, as shown in FIG. 16.

[0397] Implantable controller 170, also referred to as an internal controller or stimulation controller 170, may be understood as any implantable unit capable of controlling electrical stimulation of tissue. The controller may include an electrical signal generator, modulator, or other electrical circuitry capable of delivering electrical stimulation signals to electrode arrangements. Furthermore, the controller may process control signals and generate electrical stimulation signals in response thereto, as well as generate control signals for controlling other components of the system or device, such as implantable energy source 160 and / or implantable charger 190. Thus, a control signal may be understood as any signal capable of conveying information and / or power such that a component of the system / device can be directly or indirectly controlled.

[0398] The controller may comprise a processing unit, such as a CPU, for handling control of the electrode arrangement 150 and other components of the system. The processing unit may be a single central processing unit or may comprise two or more processing units. The processing unit may be comprised of a general-purpose microprocessor and / or an instruction set processor and / or an associated chipset and / or a special-purpose microprocessor, such as an ASIC (application-specific integrated circuit). The processing unit may also comprise memory for storing instructions and / or data. The controller 170 may be adapted to track different stimulation patterns and durations used to stimulate muscle tissue, as well as action potentials sensed by the sensor S1 in some examples. The controller 170 may further include a communicator, or communication unit 171, as outlined above, which may be configured to receive and / or transmit wireless or wired signals to / from outside the body. The communication unit 171 may allow the controller 170 to be programmed from outside the patient's body so that the operation of the electrode arrangement 150 can be programmed for optimal function.

[0399] The controller 170 and other implanted components, such as the energy source 160 and charger 190, may be surrounded by a housing to protect the components from bodily fluids. The housing may be made from one or a combination of carbon-based materials (such as graphite, silicon carbide, or carbon fiber materials), boron materials, polymeric materials (such as silicone, Peek, polyurethane, UHWPE, or PTFE), metallic materials (such as titanium, stainless steel, tantalum, platinum, niobium, or aluminum), ceramic materials (such as zirconium dioxide, aluminum oxide, or tungsten carbide), or glass. In either case, the housing should be made from a material with low permeability so that fluid movement through the housing walls is prevented.

[0400] Communication (controller, encryption / decryption, authentication / verification) Communications between external devices or between external devices and implants may be encrypted. Any suitable type of encryption may be employed, such as symmetric or asymmetric encryption. The encryption may be single-key encryption or multi-key encryption. Multi-key encryption requires multiple keys to decrypt the encrypted data. The multiple keys may be referred to as a first key, a second key, a third key, etc., or a first part of a key, a second part of a key, a third part of a key, etc. The multiple keys are combined in any suitable manner (depending on the encryption scheme and use case) to derive a combined key that can be used for decryption. In some cases, deriving a combined key means using each key one by one to decrypt the data, and using the final key results in the decrypted data.

[0401] Alternatively, multiple keys may be combined to form a single "master key" that decrypts the data. In other words, this is a form of secret sharing, where the secret is split into parts and each participant (external device, internal device) is given their own part. A minimum number of parts (keys) are required to reconstruct (decrypt) the original message. In threshold schemes, this number is less than the total number of parts (e.g., the implant's key and the key of one of the two external devices are needed to decrypt the data). In other embodiments, all keys are required to reconstruct the original secret to achieve a combined key that may decrypt the data.

[0402] It should be noted that the generator of a key for decryption does not necessarily have to ultimately send the key to another device for use on that device - in some cases the key generator is simply the facilitator of encryption / decryption, working on behalf of other devices / users.

[0403] The verification unit may comprise any suitable means for verifying or authenticating the use (i.e., user authentication) of a unit (e.g., an external device) comprising or connected to the verification unit. For example, the verification unit may comprise or be connected to an interface (UI, GUI) for receiving authentication input from a user. The verification unit may include a communications interface for receiving authentication data from a device (separate from the external device) connected to the device comprising the verification unit. The authentication input / data may consist of biometric data based on any suitable technology, such as a code, key, fingerprint, palm vein structure, image recognition, facial recognition, iris recognition, retinal scan, hand geometry, genomic comparison, etc. Verification / authentication may be provided using a third-party application installed on or in association with the verification unit.

[0404] The verification unit can be used as one part of a two-part authentication procedure, the other part consisting of, for example, conductive communication authentication, sensation authentication, or parameter authentication.

[0405] The verification unit can consist of a card reader for reading smart cards. A smart card is typically a secure microcontroller used to generate, store, and manipulate cryptographic keys. Smart card authentication involves providing a user with a smart card device for authentication. The user connects the smart card to the verification unit. Software on the verification unit interacts with the key material and other secrets stored on the smart card to authenticate the user. To activate the smart card, the user must unlock the smart card with a user PIN. Smart cards are considered a very strong form of authentication because the cryptographic keys and other secrets stored on the card are highly protected, both physically and logically, making them difficult to steal.

[0406] The verification unit consists of a personal e-ID, comparable to a passport or driver's license, for example. The e-ID system consists of security software installed on the verification unit and an e-ID that is downloaded from a trusted provider's website or provided by a trusted provider via a smart card.

[0407] The verification unit may consist of SMS-based two-factor authentication software. Other two-factor authentication systems may also be used. Two-factor authentication requires two things to be authenticated: something you know (a password, code, etc.) and something you have (an additional security code from a mobile device (SMS, e-ID, etc.) or a physical token such as a smart card).

[0408] Other authentication methods may also be employed, such as a verification unit that uses visible light to communicate with an external device instead of wired or wireless communication. A light source in the verification unit transmits a secret key or similar information to the external device (e.g., by flashing in different patterns), and the external device can use the received data to verify the user, decrypt the data, or otherwise perform authentication. Light is advantageous in this context because it is easier to block or hide from eavesdroppers than radio waves. In a similar embodiment, electromagnetic radiation is used instead of visible light to transmit the verification data to the external device.

[0409] Parameters related to the functionality of the implant may be the subject of communication and may constitute sensitive information, such as, for example, battery level, control program version, implant characteristics, implant status indicators such as the status of the implant's motor, etc. Additionally, data consisting of operating instructions may be the subject of communication and may consist of other sensitive information, such as, for example, new or updated control programs, parameters related to the specific configuration of the implant, etc. Such data may consist of, for example, instructions on how to operate the electrical stimulation device and / or the implantable constriction device, instructions to collect patient data, instructions to send feedback, etc. These parameters and data must be protected from disclosure.

[0410] controller A controller for controlling an implantable medical device according to any of the embodiments disclosed herein and for communicating with devices external to the patient's body and / or implantable sensors will now be generally described with reference to Figures 19A-19C. Figure 19A illustrates an implantable medical device M including a controller 300, for example, in conjunction with the controller C described above. I and / or C E19B shows a patient when implanted, such as a constriction device and / or electrical stimulation device 10 in the form of outlet and inlet valves 30, 40 having a valve opening 30, 40a and 40b. The implantable medical device M is part of an electrical stimulation device and / or mechanical or hydraulic constriction device and includes an active unit 302 comprised of one or more operable elements, valves, ports, etc. The active unit 302 is directly or indirectly connected to the patient's body to act on the intestine. The active unit 302 is connected to a controller 300 via an electrical connection C2. The controller 300 (further described with reference to FIG. 19B) is configured to communicate with an external device 320 (further described with reference to FIG. 19C). The controller 300 can wirelessly communicate with the external device 320 via a wireless connection WL1 and / or via an electrical connection C1.

[0411] Referring now to FIG. 19B , one embodiment of the controller 300 will be described in more detail. The controller 300 includes an internal computing unit 306 configured to control functions performed by the implantable medical device M. The computing unit 306 includes an internal memory 307 configured to store programs thereon. In the embodiment depicted in FIG. 19B , the internal memory 307 includes a first control program 310 capable of controlling functions of the implantable medical device M. The first control program 310 can be considered a program with minimal functionality that runs on the implantable medical device M only while the second control program 312 is being updated. When the implantable medical device M is running with the first control program 310, the implantable medical device M can be considered to be running in a reduced-functionality safe mode. For example, this may result in sensor data not being stored on the implantable medical device M while the first control program 310 is running, or in feedback not being transmitted from the implantable medical device M while the first control program 310 is running. Having a low complexity first control program conserves memory in the implantable medical device M and reduces the risk of the implantable medical device M failing while the second control program 312 is being updated.

[0412] The second control program 312 is a program that normally controls the implantable medical device M, providing the implantable medical device M with its full functionality and features.

[0413] The memory 307 may further include an updatable second control program 312. The term "updatable" is interpreted as meaning that the program is configured to receive incremental or iterative updates to its code or to be replaced by a new version of the code. Updates may correct previous defects in the code as well as provide new and / or improved functionality to the implant. The computing unit 306 may receive updates to the second control program 312 via the controller 300. The updates may be received wirelessly via WL1 or via electrical connection C1. As shown in FIG. 19B, the internal memory 307 of the controller 300 may store a third program 314. The third program 314 may control the functions of the implantable medical device M, and the computing unit 306 may be configured to update the second program 312 to the third program 314. The third program 314 may be utilized to restore the original state of the second program 312. Thus, the third program 314 can be considered to provide a factory reset (e.g., restore factory settings) of the controller 300. As such, the third program 314 can be included in the implant 300 in a secure portion of the memory 307 to be used to reset the software found in the controller 300 (the second control program 312) to the original manufacturer settings.

[0414] The controller 300 may include a reset function 316 connected to, part of, or transmitted to the internal computing unit 306. The reset function 316 is configured to cause the internal computing unit 306 to switch from executing the second control program 312 to executing the first control program 310. The reset function 316 may also cause the internal computing unit 306 to delete the second control program 312 from the memory 307. The reset function 316 can be operated by palpation or pressure on the patient's skin. This can be done by providing a button on the implant. Alternatively, the reset function 316 can be invoked via a timer or reset module. Temperature and / or pressure sensors can be used to sense palpation. The reset function 316 can also be activated by penetrating the patient's skin. It is even more likely that the reset function 316 can be operated by magnetic means. This can be done by utilizing a magnetic sensor and applying a magnetic force from outside the body. The reset function 316 can be configured to only respond to magnetic forces applied for a time period exceeding a limit, such as two seconds. The time limit may similarly be five, ten, or more seconds. In such cases, the implant may include a timer. Thus, the reset function 316 may include or be connected to a sensor for sensing such magnetic forces.

[0415] In addition to or as an alternative to the reset function described above, the implant may include an internal computing unit 306 (including an internal processor) that includes a second control program 312 for controlling the functions of the implantable medical device M and a reset function 318. The reset function 318 may be configured to restart or reset said second control program 312 in response to i. a timer of the reset function 318 not being reset, or ii. a malfunction of the first control program 310.

[0416] The reset function 318 may comprise, for example, a first reset function, such as a suitably operating computer, COP, function, etc., connected to the internal computing unit 306. The first reset function may be configured to restart or reset the first or second control program 312 with a second reset function. The first reset function may comprise a timer, and the first or second control program is configured to periodically reset the timer.

[0417] The reset function 318 may further include a third reset function connected to the internal computing unit and the second reset function. The third reset function may be configured to trigger a correction function to correct the first control program 310 or the second control program 312, and the second reset function may be configured to restart the first control program 310 or the second control program 312 at some point after the correction function is triggered. The correction function may be a soft reset or a hard reset.

[0418] The second or third reset function may be configured to invoke a hardware reset, for example, by triggering a hardware reset by activating an internal or external pulse generator configured to generate a reset pulse. Alternatively, the second or third reset function may be implemented by software.

[0419] The controller 300 may further include an internal wireless transceiver 308. The transceiver 308 communicates wirelessly with an external device 320 via wireless connection WL1. The transceiver may further communicate with the external devices 320, 300 via wireless connections WL2 or WL4. The transceiver can send and receive data via any of connections C1, WL1, WL2, WL4. Optionally, the external devices 320, 300 may communicate with each other, for example, via wireless connection WL3, if present.

[0420] The controller 300 may further be electrically connected C1 to an external device 320 and communicate using the patient's body as a conductor. Thus, the controller 300 may configure a wired transceiver 303 or an internal transceiver 303 for the electrical connection C1.

[0421] The controller 300 of the implantable medical device M according to FIG. 20B further comprises a feedback unit 349. The feedback unit 349 provides feedback related to the switch from the second control program 312 to the first control program 310. The feedback can, for example, indicate when the software update of the second control program 312 has started and when the update has finished. This feedback can be visually communicated to the patient, for example, via a display on the external device 320. This display can be located on a watch, phone, or other external device 320 coupled to the controller 300. Preferably, the feedback unit 349 wirelessly provides this feedback signal to the external device 320 via WL1. Possibly, the words "update started" or "update finished" or similar words with the same meaning can be displayed to the patient. As another option, different colors can be displayed, for example, green means that the update has finished, while red or yellow means that the update is in progress. Of course, any color is equally reasonable, and the user can choose between these according to personal preference. Another possibility is to have the external device 320 flash a light. In this case, the external device 320 constitutes the required light emitting device. Such a light may be, for example, an LED. Different colors may also indicate the status of the program update. One way to indicate that the update is ongoing and not yet finished may be to flash the light, i.e., turn it on and off. When the light stops flashing, the patient knows that the update is finished. Feedback may also be provided directly by the implantable medical device M or audibly by the external device 320. In that case, the implantable medical device M and the external device 320 comprise means for providing audio. Feedback may also be tactile, for example in the form of a vibration that can be sensed by the user. In such a case, the implantable medical device M or the external device 320 comprises means for providing tactile feedback, such as vibrations and / or vibrators.

[0422] As shown in FIG. 19B, the controller 300 can further include a first energy storage unit 40A. The first energy storage unit 40A executes a first control program 310. The controller 300 can further include a second energy storage unit 40B executing a second control program 312. This can further enhance security during updates, as the first control program 310 has its own separate energy storage unit 40A. The first power source 40A can be comprised of a first energy storage device 304a and / or a first energy receiver 305a. The second energy storage device 40B can be comprised of a second energy storage device 304b and / or a second energy receiver 305b. Energy can be received wirelessly by inductive or conductive means. An external energy storage unit can transfer a quantity of wireless energy to the energy receivers 305a, 305b within the patient's body, for example, by utilizing an external coil that induces a voltage in an internal coil (not shown). It is likely that the first energy receiver 305a receives energy via RFID pulses. The feedback unit 349 can provide feedback related to the amount of energy received via the RFID pulses. The amount of energy in the received RFID pulses can be adjusted based on the feedback to continuously increase the pulse frequency until a satisfactory level is reached.

[0423] The controller 300 of the implantable medical device M according to FIG. 20B further comprises an electrical switch 309. The electrical switch 309 may be mechanically connected to an implantable element configured to exert a force on a patient's body part and configured to switch as a result of the force exerted on the patient's body part exceeding a threshold. The switch 309 may, for example, be adhered to a portion of the implantable medical device M in any of the embodiments herein. Alternatively, the switch 309 may be electrically connected to the implantable medical device M and configured to switch as a result of an electrical current supplied to the implantable medical device M exceeding a threshold. The switch 309 may, for example, be connected to the electrical stimulation device 10 and / or a constriction device in the form of the outlet valve 30 and the inlet valve 40 and configured to switch when an electrical current to the implantable medical device M exceeds a threshold. Such a switch may be, for example, a switch 309 configured to switch when exposed to a temperature above a threshold, such as a bimetallic switch that switches due to heat generated by the flow of electrical current to the electrodes of the electrical stimulation device 10 or the motor of a mechanical or hydraulic constriction device. Alternatively, switch 309, configured to switch when exposed to a temperature above a threshold, can be located elsewhere on implantable medical device M so as to switch when the temperature is exceeded, thereby preventing implantable medical device M from overheating, which could cause tissue damage.

[0424] The switch 309 is configured to either cut power to the operating device or generate a control signal to the processor 306 of the implanted controller 300, which enables the controller 300 to take appropriate action, such as reducing power or turning off operation of the implanted medical device M.

[0425] The external device 320 is shown in FIG. 19C. The external device 320 can be placed anywhere on the patient's body, preferably in a convenient and comfortable location. The external device 320 may be a wristband and / or have the shape of a watch. It is also possible for the external device to be a mobile phone or other device not directly attached to the patient. As shown in FIG. 19C, the external device 320 comprises a wired transceiver 323 and an energy storage device 324. It is also possible for the external device 320 to comprise a wireless transceiver 328 and an energy transmitter 325. It is also possible for the external device 320 to comprise a computing unit 326 and a memory 327. A feedback unit 322 within the external device 320 is configured to provide feedback related to the computing unit 326. The feedback provided by the feedback unit 322 may be visual. The external device 320 may have a display that shows such visual feedback to the patient. It is equally possible for the feedback to be audible, with the external device 320 having a means for providing sound. The feedback provided by the feedback unit 322 may be tactile, such as vibration. Feedback may also be provided in the form of radio signals WL1, WL2, WL3, WL4.

[0426] The second, third or fourth communication means WL2, WL3, WL4 may be in the form of wireless communication. The second, third or fourth communication methods WL2, WL3, WL4 may preferably be in the form of communication based on electromagnetic waves or radio waves. The second, third or fourth communication methods WL2, WL3, WL4 may be based on telecommunication methods. The second, third or fourth communication methods WL2, WL3, WL4 may consist of or relate to items from the following list: Wireless Local Area Network (WLAN), Bluetooth, Bluetooth 5, BLE, GSM or 2G (second generation cellular technology), 3G, 4G or 5G.

[0427] The external device 320 may be adapted to make electrical connection C1 with the implantable medical device M using the body as a conductor, where the electrical connection C1 is used for conductive communication between the external device 320 and the implantable medical device M.

[0428] Encryption / Decryption In one embodiment, communications between the controller 300 and the external device 320 via any of the communication methods WL2, WL3, WL4, and C1 may be encrypted and / or decrypted with public and / or private keys. For example, the controller 300 may be configured with a private key and a corresponding public key, and the external device 320 may be configured with a private key and a corresponding public key.

[0429] The controller 320 and the external device 320 can exchange public keys and communicate using public key encryption. Those skilled in the art can utilize known methods for exchanging keys.

[0430] The controller may encrypt data to be sent to the external device 320 using a public key corresponding to the external device 320. The encrypted data is sent to the external device via wired, wireless, or electrical communication channels C1, WL1, WL2, WL3. The external device 320 may receive the encrypted data and decrypt it using a private key configured on the external device 320 (a private key corresponding to the public key with which the data was encrypted). The external device 320 may send the encrypted data to the controller 300. The external device 320 may encrypt the data to be sent using a public key corresponding to the private key of the controller 300. The external device 320 may send the encrypted data to the implant's controller directly or indirectly via wired, wireless, or electrical connections C1, WL1, WL2, WL3, WL4. The controller may receive the data and decrypt it using the private key included in the controller 300.

[0431] As an alternative to the public key encryption described with reference to Figures 19A-19C, data transmitted between the controller 300 of the implantable medical device M and the external devices 320, 330, or between the external devices 320, 330 and the controller 300, may be signed. In the method of transmitting data from the controller 300 to the external devices 320, 330, the data transmitted from the controller 300 may be signed using the private key of the controller 300. The data may be transmitted over communication channels or connections C1, WL1, WL2, WL3, WL4. The external devices 320, 330 can receive the message and verify the authenticity of the data using the public key corresponding to the private key of the controller 300. In this way, the external devices 320, 330 can determine that the data was transmitted by the controller 300 and not by some other device or source.

[0432] A method for communicating between an external device 320 and a controller 300 of an implantable medical device M using a composite key will now be described with reference to FIGS. 19A-19C. The first step of the method involves receiving, at the implant, a first key from an external device 320, 330 via wireless transmissions WL1, WL2, WL3, WL4, etc. The method further includes receiving, at the implant, a second key via wireless communications WL1, WL2, WL3. The second key may be generated by a second external device separate from the external device 320, 330, or may be generated by another external device that is the generator of the second key on behalf of the second external device 320, 330. The second key may be received at the implant from any one of the external device 320, the second external device 330, and the generator of the second key. The second external device may be controlled by an administrator or other party. The other external device may be controlled by the implant manufacturer, medical staff, an administrator, etc.

[0433] If the controller 300 receives the second key from the external device 320, this means that the second key is routed through the external device, either from the second external device 330 or from another external device (generator). Routing may be performed as described in a tenth aspect of this specification. In these cases, the implant and / or external device has the necessary features and functionality (described in each section of this specification) to perform such routing. Using the external device 320 as a relay, with or without confirmation from the patient, may provide an additional layer of security because the external device 320 may not need to store or otherwise handle the decrypted information. As such, the external device 320 may be lost without losing the decrypted information. The controller 300 includes a computing unit 306 configured to derive a combined key by combining the first and second keys with a third key held by the controller 300 (e.g., in the memory 307 of the controller 300). The combined key is used by the computing unit 306 to decrypt encrypted data transmitted by wireless transmission WL1 from the external device 320 to the controller 300. Optionally, the decoded data may be used by computing unit 306 to modify the operation of implantable medical device M. In some embodiments, the method further includes at least one of updating a control program running in controller 300 based on the decoded data and operating implantable medical device M using operational instructions in the decoded data.

[0434] A method for encrypted communication between an external device 320 and a controller 300 may be configured as follows: receiving, at the external device 320, by 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 that is the generator of the second key on behalf of the second external device 330, the first key being received from either the second external device 330 or the generator of the second key; receiving the second key from the controller 300 at the external device 320 by means of the wireless transceiver 328; the computing unit 326 of the external device 320 derives a combined key by combining the first key and the second key with a third key held by the external device 320 (e.g., in the memory 307); transmitting encrypted data from the implant to the external device and receiving the encrypted data at the external device by the wireless transceiver 328; The computation unit 326 decrypts the encrypted data in the external device 320 using the combined key.

[0435] As mentioned above, additional keys may be required to decrypt the data. As a result, wireless transceiver 328 is configured as follows: - receiving a fourth key from a third external device; Here, the arithmetic unit 326 is configured as follows: - combining the first, second, and fourth keys with a third key held by the external device to derive a combined key; - Decrypt the encrypted data using the combined key.

[0436] These embodiments further increase security in communications. The computing unit 326 may be configured to validate communications between the implant and the external device, where the validation comprises: - measuring a patient parameter by an external device 320; - receiving measured parameters of the patient from the implantable medical device M; - comparing the parameters measured by the implantable medical device M with the parameters measured by the external device 320; - checking the connection based on the comparison; - After verification, the encrypted data is decrypted on an external device.

[0437] In some embodiments, the keys described in this section can be generated based on data sensed by sensors described below. A seed is an initial value that is input into a pseudo-random number generator to begin the random number generation process. This allows the seed to be difficult to predict without access to or knowledge of the patient's underlying physiological parameters, providing additional security to the generated keys.

[0438] Methods of communication Next, a method of communication between the external device 320 and the implantable medical device M when the implantable medical device M is implanted in a patient and the external device 320 is located outside the patient's body will be described with reference to FIGS. 19A-19C. The external device 320 is adapted to be in electrical connection C1 with the controller 300, using the body as a conductor. The electrical connection C1 is used for conductive communication between the external device 320 and the implantable medical device M. Both the controller 300 and the external device 320 include a wireless transceiver 308 for wireless communication C1 between the controller 300 and the external device 320. The wireless transceiver 308 (included in the controller 300) may, in some embodiments, include a sub-transceiver for receiving data from the external device 320 and other external devices, e.g., using different frequency bands, modulation schemes, etc.

[0439] In a first step of the method, the electrical connection C1 between the controller 300 and the external device 320 is confirmed and thereby authenticated. The confirmation and authentication of the electrical connection can be performed as described below. In such cases, the implant and / or the external device have the necessary features and functionality (described in various sections herein) to perform such authentication. Performing authentication according to these aspects can increase the security of the authentication, as a malicious third party may need to know or access the patient's transient physiological parameters or detect randomized sensations occurring at or within the patient.

[0440] The controller 300 of the implantable medical device M may include a first transceiver 303 configured to establish electrical connection C1 with the external device 320 using the body as a conductor. Alternatively, the first transceiver 303 of the controller 300 may be wireless. The external device 320 may include a first external transmitter 323 configured to establish electrical connection C1 with the implantable medical device M using the body as a conductor and a wireless transmitter configured to transmit wireless communication WL1 to the controller 300. Alternatively, the first external transmitter 323 of the external device 320 may be wireless. The first external transmitter 323 of the external device 320 and the wireless transmitter may be the same transmitter or may be separate transmitters.

[0441] The controller 300 may include an arithmetic unit 306 configured to verify an electrical connection between the external device 320 and the internal transceiver 303 and to accept a wireless communication (of data) WL1 from the external device 320 based on the verification.

[0442] The data may be transmitted from external device 320 to controller 300 wirelessly, for example, using wireless transceivers in controller 300 and external device 320. Alternatively, the data may be transmitted via electrical connection C1. Upon verification, the received data may be used to instruct implantable medical device M. For example, control program 310 running in controller 300 may be updated, or the operating instructions in the received data may be used to operate controller 300. This may be processed by computing device 306.

[0443] The method may comprise wirelessly transmitting data from the external device 320 to the controller 300, and may comprise wirelessly transmitting encrypted data. Several methods may be used to decrypt the encrypted data (e.g., using the computing unit 306).

[0444] In one embodiment, a key is transmitted from the external device 320 to the controller 300 using the confirmed conductive communication path C1 (i.e., an electrical connection). The key is received at the controller (by the first internal transceiver 303). The key is then used to decrypt the encrypted data.

[0445] In some embodiments, the key alone is sufficient to decrypt the encrypted data. In other embodiments, an additional key is required to decrypt the data. In one embodiment, the key is transmitted from the external device 320 to the controller 300 using a confirmed conductive communication channel C1 (i.e., an electrical connection). The key is received at the controller 300 (by the first internal transceiver 303). A second key is transmitted from the external device 320 using wireless communication WL1 (by the wireless transceiver 208) and received at the controller 300 by the wireless transceiver 308. The computing unit 306 then derives a combined key from the key and the second key, which is used to decrypt the encrypted data.

[0446] In yet another embodiment, a key is transmitted from the external device 320 to the controller 300 using the confirmed conductive communication path C1 (i.e., electrical connection). The key is received at the controller (by the first internal transceiver 303). A third key is transmitted wirelessly to the implant over WL2 from a second external device 330 separate from the external device 320. The third key may be received by a second wireless receiver (part of the wireless transceiver 308) of the controller 300 configured to receive wireless communication over WL2 from the second external device 330.

[0447] The first and third keys may be used by computing unit 306 to derive a combined key, which then decrypts the encrypted data, which is then used to instruct implantable medical device M as described above.

[0448] The second external device 330 may be controlled by a caregiver, for example, to further enhance the security and validity of the data transmitted and decoded by the controller 300 .

[0449] Note that in some embodiments, the external device is further configured to receive a secondary wireless communication WL2 from the second external device 330 and transmit data received from the secondary wireless communication WL2 to the implantable medical device M. This routing of data may be accomplished using the wireless transceivers 308, 208 (i.e., using the wireless connection WL1 or using the additional wireless connection WL4 between the controller 300 and the external device 320). In these cases, the implant and / or the external device comprise the necessary features and functionality to perform such routing. Consequently, in some embodiments, the third key is generated by the second external device 330 and transmitted to the external device 320 via WL2, and the external device 320 routes the third key to the controller 300 to be used for decrypting the encrypted data. In other words, wirelessly transmitting the third key from a second external device separate from the external device to the implant consists of routing the third key via the external device 320. The use of the external device 320 as a relay, with or without patient verification, can provide an additional layer of security by eliminating the need for the external device 320 to store or otherwise handle the decrypted information, and thus the external device 320 can be lost without losing the decrypted information.

[0450] In yet another embodiment, a key is transmitted from the external device 320 to the controller 300 using the confirmed conductive communication channel C1 (i.e., electrical connection). The key is received at the implant (by the first internal transceiver 303). A second key is wirelessly transmitted from the external device 320 to the controller 300 over WL1 and received at the controller 300. A third key is wirelessly transmitted from a second external device, separate from the external device 320, to the controller 300 over WL4. Encrypted data transmitted from the external device 320 to the controller 300 is decrypted using a composite key derived from the key, the second key, and the third key. The external device may be a wearable external device.

[0451] The external device 320 may be a mobile phone. The second external device 330 may be a handset, a server, or cloud-based.

[0452] In some embodiments, the electrical connection C1 between the external device 320 and the controller 300 is achieved by placing a conductive member 321 configured to interface with the external device 320 in electrical connection with the patient's skin for conductive communication C1 with the implant. In such cases, the implant and / or external device include the necessary features and functionality (described in various sections herein) to effect such conductive communication. Thus, an additional layer of security, in addition to encryption, may be provided by electrically confining the communication to a conductive path, such as the external device 320, the conductive member 321, the conductive connection C1, and the controller 300, meaning that the communication is excessively difficult to intercept by a third party not in physical contact with, or at least in close proximity to, the patient.

[0453] Authentication / Validation To further increase the security of communications between the controller 300 and the external device 320, different types of authentication, verification, and / or encryption can be employed. In some embodiments, the external device 320 includes a verification unit 340. The verification unit 340 can be any type of unit suitable for user verification, i.e., a unit configured to receive authentication input from a user, to authenticate conductive communications between the implant and the external device. In some embodiments, the verification unit and the external device include means for collecting authentication input from a user (who may or may not be a patient). Such means can include a fingerprint reader, a retinal scanner, a camera, a GUI for entering a code, a microphone, a device configured to draw blood, and the like. Thus, the authentication input can include a code or something based on a biometric technology selected from the list of fingerprint, palm vein structure, image recognition, facial recognition, iris recognition, retinal scan, hand geometry, and genomic comparison. The means for collecting authentication input can instead be part of the conductive member 321, which comprises any of the above-mentioned example functions, such as a fingerprint reader or other type of biometric reader.

[0454] In some embodiments, security can be enhanced by receiving authentication input from a user by verification unit 340 of external device 320 and using the authentication input to authenticate conductive communications between controller 300 and the external device. If authentication is affirmative, conductive communication channel C1 is used to configure transmission of conductive communications by external device 320 to controller 300 and / or transmission of conductive communications by controller 300 to external device 320. In other embodiments, positive authentication is required before operating implantable medical device M based on received conductive communications and / or before updating control programs executing within controller 300 as described above.

[0455] 19A-19C further show that implantable medical device M is connected to sensation generator 381. Sensation generator 381 may be configured to generate a sensation. Sensation generator 381 may be included within implantable medical device M or may be a separate unit. Sensation generator 381 may be implanted. Alternatively, sensation generator 381 may not be so implanted, but may be positioned to be connected to the patient such that only the patient can experience the generated sensation. Controller 300 is configured to store authentication data associated with the sensation generated by sensation generator 381.

[0456] The controller 300 is further configured to receive input authentication data from the external device 320. The authentication data related to the generated sensation may be stored by the memory 307 of the controller 300. The authentication data may include information about the generated sensation so that it can be analyzed, such as compared to the input authentication data, to authenticate the connection, communication, or device. The input authentication data relates to information generated by a patient entering the external device 320. The input authentication data may be actual patient input or an encoded version of the patient input encoded by the external device 320. The authentication data and the input authentication data may be comprised of multiple sensations or sensory components.

[0457] The authentication data may include a timestamp. The input authentication data may consist of a timestamp of the input from the patient. The timestamp may be the time of an event, such as the generation of a sensation by the sensation generating device 381 or the creation of the input authentication data by the patient. The timestamp may be encoded. The timestamp may be characterized as an arbitrary unit of time, i.e., not actual time. The timestamp may be provided by an internal clock 360 of the controller 300 and an external clock 362 of the external device 320. The clocks 360, 362 may be synchronized with each other. The clocks 360, 362 may be synchronized by using a conductive connection C1 or a wireless connection WL1 to communicate synchronization data from the external device 320 and its respective clock 362 to the controller 300 and its respective clock 360, and vice versa. Synchronization of the clocks 360, 362 may be performed continuously and may not rely on secure communication.

[0458] Validating a connection involves calculating the time difference between the sensory timestamp and the patient input timestamp and validating the connection when the time difference is determined to be less than a threshold. An example threshold is 1 second. The analysis may also be configured with a lower threshold to filter patient inputs that are faster than normal human response times. An example lower threshold is 50 ms.

[0459] The authentication data comprises a number of times the sensation generator generated a sensation, the input authentication data comprises input from the patient regarding a number of times the patient detected a sensation, and authenticating the connection comprises authenticating the connection upon determining that the number of times in the authentication data and the input authentication data are equal.

[0460] The method for authenticating a connection between implantable medical device M and external device 320 optionally includes the following steps.

[0461] The sensation generating device 381 generates a sensation detectable by the patient's senses. The sensation may be comprised of multiple sensory components. The sensation or sensory component may be comprised of vibration (e.g., a constant frequency mechanical vibration), sound (e.g., a superposition of constant frequency mechanical vibrations), optical signal (e.g., an invisible light pulse such as an infrared pulse), light signal (e.g., a visible light pulse), electrical signal (e.g., an electrical current pulse), or thermal signal (e.g., a heat pulse). The sensation generator may be implantable, configured to be worn in contact with the patient's skin, or may be capable of generating a sensation without physical contact with the patient, such as a beeping alarm. The sensation may be configured to be consistently felt by the patient's senses while not posing any risk of harming or affecting the patient's internal biological processes.

[0462] The controller 300 stores authentication data associated with the generated sensation.

[0463] The input authentication data may be provided by the patient through input into the external device, such as by actuating an electrical switch, using a biometric input sensor, or input into a digital interface running on the external device 320, to name a few examples.

[0464] The input authentication data is transmitted from the external device to the controller 300. When the step is executed, the controller 300 may perform an analysis.

[0465] Transmit authentication data from implantable medical device M to external device 320. If a step is performed, analysis may be performed by external device 320. The wireless connection WL1 or the conductive connection C1 may be used to transmit the authentication data or the entered authentication data.

[0466] Authenticating the connection based on the input authentication data and an analysis of the authentication data, such as comparing the number of sensations generated and sensations experienced, or comparing the authentication data and a timestamp of the input authentication data, may be performed by implantable medical device M.

[0467] After positive authentication, further data is communicated between controller 300 and external device 320. The further data can be communicated using wireless connection WL1 or conductive connection C1. The further data may consist of data for updating control program 310 running within controller 300 or operating instructions for operating implantable medical device M.

[0468] When the analysis is performed by the controller 300, the external device 320 continuously requests or receives information about the authentication status of the connection between the controller 300 and the external device 320, and when the external device 320 determines that the connection is authenticated, further data can be sent from the external device 320 to the controller 300.

[0469] If the analysis is performed by the external device 320, the controller 300 continuously requests or receives information about the authentication status of the connection between the controller 300 and the external device 320, and if the controller 300 determines that the connection is authenticated, further data may be sent from the controller 300 to the external device 320.

[0470] The main advantage of authenticating a connection according to this method is that only the patient experiences the sensation, and therefore only the patient can authenticate the connection by providing an authentication input corresponding to the occurrence of the sensation.

[0471] Security Module 19A-19C, communication unit 300 or internal controller 300 or control unit 300 comprises a wireless transceiver 308 for wireless communication with an external device, a security module 389, and a central unit, also referred to herein as computing unit 306, which are considered equivalent. Central unit 306 is configured to communicate with wireless transceiver 308, security module 389, and implantable medical device or active unit 302. Wireless transceiver 308 is configured to receive a communication from external device 320 that includes at least one instruction for implantable medical device MD, and to transmit the received communication to central unit or computing unit 306. Central unit or computing unit 306 is configured to transmit a secure communication derived from the received communication from external device 320 to security module 389, which is configured to decrypt at least a portion of the secure communication and verify the authenticity of the secure communication. The security module is further configured to send the response communication to the central unit or computing unit 306, which is configured to communicate at least one instruction to the active unit 302. In the embodiment shown in Figures 19A-19C, the at least one instruction is based on the response communication or a combination of the response communication and a received communication from the external device 320.

[0472] 19A-19C, the security module 389 configures a set of rules for accepting communications from the central unit or computing unit 306. In the embodiment shown in Figures 19A-19C, the wireless transceiver 308 is configured to be capable of being placed in an off mode in which no wireless communications are transmitted or received by the wireless transceiver 308. The set of rules consists of a rule that provides that communications from the central unit or computing unit 306 to the security module 389 or active unit 302 are accepted only when the wireless transceiver 308 is placed in the off mode.

[0473] In the embodiment shown in Figures 19A-19C, the set of rules consists of a rule that specifies that communications from the central unit or computing unit 306 will be accepted only if the wireless transceiver 308 has been placed in off mode for a specific period of time.

[0474] In the embodiment shown in FIGS. 19A-19C, the central or computing device 306 is configured to verify a digital signature of a received communication from the external device 320. The digital signature may be a hash-based digital signature based on a biometric signature from a patient or medical professional. The set of rules further includes a rule that specifies that a communication from the central device 306 is accepted only if the digital signature of the received communication is verified by the central device 306. Verification may include, for example, comparing the digital signature or a portion of the digital signature with a previously verified digital signature stored in the central unit 306. The central device 306 may be configured to verify the size of a received communication from the external device, and the set of rules may include a rule that specifies that a communication from the central device 306 is accepted only if the size of the received communication is verified by the central device 306. Thus, the central device may have rules that specify that communications above or below a specified size range are rejected.

[0475] 19A-19C, the wireless transceiver is configured to receive a message from an external device 320 that is encrypted with at least a first layer and a second layer of encryption. The central unit 306 decrypts the first layer of encryption and transmits at least a portion of the message that comprises the second layer of encryption to the security module 389. The security module 389 then decrypts the second layer of encryption and transmits a response communication to the central unit 306 based on the portion of the message decrypted by the security module 389.

[0476] In the embodiment shown in Figures 19A-19C, the central unit 306 is configured to decrypt the portion of the message that constitutes the digital signature, such that the digital signature can be verified by the central unit 306, and the central unit 306 is configured to decrypt the portion of the message that constitutes the message size information, such that the message size can be verified by the central unit 306.

[0477] In the embodiment shown in Figures 19A-19C, the central device 306 is configured to decrypt a first part and a second part of the message, the first part including a checksum to verify the authenticity of the second part.

[0478] In the embodiment shown in Figures 19A-19C, the response communication sent from security module 389 includes a checksum, and central unit 306 is configured to verify the authenticity of at least a portion of the message decrypted by central unit 306 using the received checksum, i.e., by adding up portions of the message decrypted by central unit 306 and comparing the sum with the checksum.

[0479] 19A-19C, the rule set further includes a rule related to the data transfer rate between the central unit 306 and the security module 389. The rule may stipulate that communication should be refused or terminated if the data transfer rate exceeds a set maximum data rate, thereby making it more difficult for unauthorized parties to inject malicious code or instructions into the medical implant.

[0480] 19A-19C, the security module 389 is configured to decrypt the portion of the message that includes the digital signature that is encrypted with the second layer of encryption so that the digital signature can be verified by the security module 389. The security module 389 then sends a response communication to the central unit 306 based on the results of the verification, which can be used by the central unit 306 for further decryption of the message or to determine whether instructions in the message should be communicated to the active unit 302.

[0481] 19A-19C, central unit 306 can decrypt some of the incoming communications from external device 320 only when wireless transceiver 308 is placed in off mode. Alternatively, or as an additional layer of security, central unit 306 can be restricted to only communicating instructions to active unit 302 of implantable medical device MD when wireless transceiver 308 is placed in off mode. This prevents attacks from occurring while central unit 306 is communicating with active unit 302.

[0482] 19A-19C, the embedded controller 300 is configured to use the wireless transceiver 308 to receive a message from the external device 320 that includes a first unencrypted portion and a second encrypted portion. The embeddable controller 300 (e.g., the central unit 306 or the security module 389) then decrypts the encrypted portion and uses the decrypted portion to verify the authenticity of the unencrypted portion. In this manner, computational power, and therefore energy, can be saved by encrypting only those portions of the message necessary to authenticate the remainder (e.g., a checksum and / or digital signature) rather than encrypting the entire communication.

[0483] 19A-19C, central device 306 is configured to transmit the encrypted portion to security module 389 and receive a response communication from security module 389 based on the information contained in the encrypted portion being decrypted by the security module. Central device 306 is then configured to verify the authenticity of the unencrypted portion using the response communication. The unencrypted portion may constitute at least a portion of at least one instruction for implantable medical device 306.

[0484] 19A-19C, implantable controller 300 is configured to use wireless transceiver 308 to receive a message from external device 320 that includes information related to at least one of a patient's physiological parameter and a physical parameter of implantable medical device MD, and to verify the authenticity of the message using the received information. The patient's physiological parameter may be a parameter such as a parameter based on one or more of body temperature, heart rate, and saturation value.

[0485] The physical parameters of the implantable medical device MD may consist of at least one of the current settings or values ​​of the implantable medical device MD, advance instructions sent to the implantable medical device MD, or the ID of the implantable medical device MD.

[0486] Portions of the message containing information related to the patient's physiological parameters and / or physical or functional parameters of the implanted medical device MD may be encrypted, and the central unit 306 may be configured to send the encrypted portions to the security module 389 and to receive a response communication from the security module 389 based on the information decrypted by the security module 389.

[0487] In the embodiment shown in FIGS. 19A-19C, security module 389 is a hardware security module comprising at least one hardware-based key. Security module 389 may have the ability to provide evidence of tampering, such as visible signs of tampering or logging and warnings. Security module 389 may also be "tamper-resistant," rendering security module 389 inoperable if tampering is detected. For example, a response to tampering may be to delete the key if tampering is detected. Security module 389 is comprised of one or more secure crypto-processor chips. The hardware key of security module 389 may have a corresponding hardware key that can be placed on external device 320. The corresponding external hardware-based key may be located on a key card that can be connected to external device 320.

[0488] In alternative embodiments, security module 389 is a software security module including at least one software-based key, or a combination of a hardware-based security module and a software-based key. The software-based key may correspond to a software-based key in external device 320. The software-based key may correspond to a software-based key on a key card connectable to external device 320.

[0489] In the embodiment shown in Figures 19A-19C, external device 320 is a handheld external device, although in alternative embodiments the external device may be a remote external device or a cloud-based external device.

[0490] In the embodiment shown in Figures 19A-19C, the at least one instruction to the implantable medical device MD includes an instruction to change the operational state of the implantable medical device MD.

[0491] 19A-19C, wireless transceiver 308 is configured to wirelessly communicate with external device 320 using electromagnetic waves at frequencies below 100 kHz, and more specifically below 40 kHz. As such, wireless transceiver 308 is configured to communicate with external device 320 using "very low frequency" communications (VLF). VLF signals have the ability to penetrate the titanium housing of implantable medical device MD, allowing the electronics of implantable medical device MD to be completely encapsulated within the titanium housing.

[0492] The wireless transceiver 308 is configured to wirelessly communicate with the external device 320 using a first communication protocol, and the central device 306 is configured to communicate with the security module 389 using a second, different communication protocol. This adds an additional layer of security because security mechanisms may be built into the electronic circuitry and / or software of the central device 306 that enable the transfer from the first communication protocol to the second communication protocol. The wireless transceiver 308 may be configured to wirelessly communicate with the external device using a standard network protocol, which may be one of an RFID-type protocol, a WLAN-type protocol, a Bluetooth (BT)-type protocol, a BLE-type protocol, an NFC-type protocol, a 3G / 4G / 5G-type protocol, and a GSM-type protocol. Alternatively, or in combination, the wireless transceiver 308 may be configured to wirelessly communicate with the external device 320 using a proprietary network protocol. The wireless transceiver 308 may be an ultra-wideband (UWB) transceiver, and wireless communication between the implantable controller 300 and the external device 320 may therefore be based on UWB. The use of UWB technology allows for positioning of the remote control 320'' that the implantable medical device MD can use as a way to determine that the external device 320 is in a location that the implantable medical device MD and / or patient can recognize as correct, e.g., within reach of the patient and / or in direct proximity to the medical device MD and / or patient, such as within one or two meters of the implantable medical device MD. Alternatively, UWB and BT can be used in combination, in which case UWB communication can be used to authenticate the BT communication since it is easier to transfer larger data sets using BT.

[0493] Variable Impedance According to one embodiment described with reference to FIGS. 19A-19C, the communication unit 300 or controller of the implantable medical device MD includes a receiving unit 305 or energy receiver 305 consisting of a coil 192 (specifically shown in FIG. 19B′) configured to receive transcutaneously transmitted energy. The receiving unit further includes 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 305 further includes a switch 195a disposed between the variable impedance 193 and the coil 192 to turn off the electrical connection between the variable impedance 193 and the coil 192. The communication unit 300 or controller 300 is configured to control the variable impedance 193 to vary the impedance, thereby adjusting the coil 192 based on the measured parameter. The communication unit 300 or controller 300 is further configured to control the switch 195a to turn off the electrical connection between the variable impedance 193 and the coil 192 in response to the measured parameter exceeding a threshold. The controller 300 may further be configured to vary the variable impedance in response to a measured parameter exceeding a threshold. In this manner, if an excessive amount of energy is received, the coil may be adjusted or turned off to reduce the amount of energy received. The measurement unit 194 is configured to measure a parameter related to the energy received by the coil 192 over time and / or to measure a parameter related to changes in the energy received by the coil 192, for example, by measuring the time derivative of the received energy. The variable impedance 193 is disposed in series with the coil 192 in the embodiment shown in FIG. 19B'. However, in other embodiments, it is also contemplated that the variable impedance may be disposed in parallel with the coil 192.

[0494] First switch 195a is disposed at first end portion 192a of coil 192, and implantable medical device MD further includes second switch 195b disposed at second end portion 192a of coil 192 so that coil 192 can be completely disconnected from other portions of implantable medical device MD. Receiving unit 305 is configured to receive transcutaneously transmitted energy in pulses according to a pulse pattern. In the embodiment shown in FIG. 19B', measuring unit 194 is configured to measure a parameter related to the pulse pattern. Controller 300 is configured to control variable impedance 193 in response to the pulse pattern deviating from a predefined pulse pattern. Controller 300 is configured to control switch 195a to turn off the electrical connection between variable impedance 193 and coil 192 in response to the pulse pattern deviating from the predefined pulse pattern. The measuring unit is configured to measure a temperature within implantable medical device MD or within the patient's body, and controller 300 is configured to control first and second switches 195a, 195b in response to the measured temperature.

[0495] The variable impedance 193 may be composed of a resistor and a capacitor, and / or a resistor and an inductor, and / or an inductor and a capacitor. The variable impedance 193 may be composed of a digitally tuned capacitor or a digital potentiometer. The variable impedance 193 may be composed of a variable inductor. The first and second switches are composed of semiconductors such as MOSFETs. The variation in impedance is configured to reduce the effective power received by the receiving unit. As shown in FIG. 19B', the variable impedance 193, the first and second switches 195a and 195b, and the measurement unit 194 are connected to the communication unit / controller 300, and the receiving unit 305 is connected to the energy storage unit 40, which can store the energy received by the receiving unit 305.

[0496] For added security, multiple external devices with different permission levels can be used. FIG. 20 illustrates one embodiment of a system for charging, programming, and communicating with a controller 300 of an implantable medical device MD. FIG. 20 further illustrates communication and interaction between different external devices, which may be devices held and operated by a patient, devices held and operated by a healthcare provider (HCP), or a dedicated data infrastructure (DDI), for example, infrastructure provided by the manufacturer of the implantable medical device MD or external devices 320′, 320″, 320′″. The system of the embodiment of FIG. 20 is composed of three external devices 320′, 320″, 320′″ that can communicate with the controller 300. The basic idea is to ensure security of communications with and operation of the medical device MD by having three external devices 320′, 320″, 320′″ with different levels of authority. The lowest level of authority is given to a patient-operated remote control 320″. The remote control 320″ has authority to operate functions of the implantable medical device MD via the implantable controller 300 based on patient input. The remote control 320'' also has the authority to obtain necessary data from the controller 300. The remote control 320'' can only operate the controller 300 by communicating with the software currently running on the controller 300 with its current settings or software. The next level of authority is given to the patient-external interrogation device (P-EID) 320''', which is a charging and communication unit held by the patient but partially remotely operated by the healthcare provider (HCP). (This is typically a physician in a clinic providing treatment with the aid of the implanted medical device MD.) When remotely operated by the HCP, the P-EID 320'' has the authority to make configuration changes to the software running on the implantable medical device MD's controller 300. The highest level of authority is given to the HCP-EID 320', which is a charging and communication unit that the HCP physically holds in the HCP's clinic.The HCP-EID 320' has the authority to freely modify or replace the software running on the controller 300 when the patient is physically present at the clinic or HCP.

[0497] Starting with the lowest level of authority, remote control 320'' comprises a wireless transceiver 328 for communicating with implantable medical device MD. Remote controller 320'' can control the operation of implantable medical device MD via controller 300 by controlling preset functions of implantable medical device MD, for example, to operate active portions of implantable medical device MD to perform the intended functions of implantable medical device MD. In the embodiment shown in FIG. 20, wireless transceiver 328 comprises a Bluetooth (BT) transceiver, and remote control 320'' is configured to communicate with implantable medical device MD using BT. In another configuration, remote controller 320'' communicates with implantable medical device MD using a combination of ultra-wideband (UWB) wireless communication and BT. The use of UWB technology enables location of the remote controller 320'' which can be used by the implantable medical device MD as a way to determine that the remote controller 320'' is in a location that the implantable medical device MD and / or patient will recognize as correct, for example, within reach of the patient and / or in direct proximity to the medical device MD and / or patient, such as within one or two meters of the implantable medical device MD.

[0498] UWB communications are achieved by generating wireless energy at specific time intervals and occupying a wide bandwidth, allowing for pulse position modulation and time modulation. Information can also be modulated onto UWB signals (pulses) by encoding the polarity and / or amplitude of the pulses and / or by using orthogonal pulses. UWB wireless systems can be used to determine the "time of flight" of transmissions at various frequencies. This helps overcome multipath propagation, since some frequencies have line-of-sight trajectories while others have long indirect paths. Cooperative symmetric two-way photometry techniques enable distance measurements with high resolution and accuracy. UWB is useful for real-time location systems, and its high accuracy and low power make it suitable for radio-frequency-sensitive environments.

[0499] In embodiments where a combination of BT and UWB technologies is used, UWB technology can be used for location-based authentication of the remote control 320'', and communication and / or data transfer can occur using BT. In some embodiments, the UWB signal can also be used as a wake-up signal for the controller 300, or as a wake-up signal for the BT transceiver of the implantable medical device MD so that it is turned off when not in use, thereby eliminating the risk of BT being intercepted or the risk of the implantable medical device MD's controller 300 being hacked by BT communications. In embodiments where a combination of BT / UWB is used, the UWB connection can also be used to transmit data. Alternatively, the UWB connection can be used for transmitting portions of the data, such as sensitive portions of the data, or for transmitting a key to unlock encrypted communications sent via BT.

[0500] The remote control 320'' contains control logic that executes a control logic application for communicating with the implanted medical device MD. The control logic can receive input directly from control buttons 335 located on the remote control 320'' or from a control interface 334i displayed on a patient-operated display device 334. In embodiments in which the remote control 320'' receives input from a control interface 334i displayed on a patient-operated display device 334, the remote control 320'' transmits the control interface 334i in the form of a webview, i.e., a remote interface that runs in a sandbox environment on the patient's display device 334. The patient's display device 334 can be, for example, a mobile phone, tablet, or smartwatch. In the embodiment shown in FIG. 20, the patient's display device 334 communicates with the remote controller 320'' via BT. The control interface 334i in the form of a webview is transmitted from the remote controller 320'' to the patient's display device 334 via BT. Control commands in the form of inputs from the patient to the control interface 334i are sent from the patient display device 334 to the remote control 320'', providing inputs to the remote control 320'' equivalent to inputs that could be provided using the control buttons 335. Control commands created within the patient display device 334 are encrypted within the patient display device 334 and sent to the remote control 320' using BT.

[0501] The patient's display device 334 (when the display device 334 is a mobile phone or tablet) may include an auxiliary wireless transmitter to provide an auxiliary wireless connection, such as Wi-Fi or a mobile connection (e.g., according to 3G, 4G, or 5G standards). The auxiliary wireless connection may need to be disconnected to enable communication with the remote control 320''. Disconnecting the auxiliary wireless connection reduces the risk that the integrity of the control interface 334i displayed on the patient's display device 334 will be compromised or that the control interface 334i displayed on the patient's display device 334 will be remotely controlled by an unauthorized device.

[0502] In alternative embodiments, the control commands are generated by the patient's display device, encrypted, and sent to the DDI 330. The DDI 330 can modify the generated control commands into commands readable by the remote control 320'' before further encrypting the control commands for transmission to the remote control 320'', add an additional layer of encryption before transmitting the control commands to the remote control 320'', or simply act as a router to relay the control commands from the patient's display device 334 to the remote control 320''. It is also possible for the DDI 330 to add an end-to-end encryption layer directed to the implanted medical device MD so that only the implanted medical device MD can decrypt the control commands and execute the commands intended by the patient.

[0503] The patient display device 334 can have first and second applications associated with the implanted medical device MD. The first application is a control application that displays a control interface 334i for controlling the implanted medical device MD, while the second application is a general application for providing the patient with an interface for providing general information about the status of the implanted medical device MD or information from the DDI 330 or HCP, or for providing general input from the patient to the DDI 330 or HCP related to the patient's general well-being, the patient's lifestyle, or the functioning of the implanted medical device MD. The second application does not provide input to the remote controller 320'' and / or the implanted medical device MD and therefore handles less sensitive data. As such, the general application can be configured to function even when all auxiliary wireless connections are activated, but must temporarily deactivate the auxiliary wireless connections to switch to the control application that handles more sensitive control commands and communications with the implanted medical device MD. The control application can also be a sub-application running within the general application, in which case launching the control application as a sub-application within the general application may require temporary deactivation of the auxiliary wireless connections. In the embodiment shown in Figure 20, access to the control application requires the use of optical and / or NFC means of the hardware key 333' in combination with biometric input on the patient's display device, while access to the general application requires only biometric input on the patient's display device and / or a pin code. Alternatively, a two-factor authentication solution such as a digital key in combination with a pin code can be used to access the general and / or control applications.

[0504] In embodiments where the patient's display device 334 is configured to display and interact only with a web view provided by another unit in the system, the web view may be a back-end view provided on the DDI 330, and in such embodiments, the patient's interaction with the control interface on the patient's display device is equivalent to the patient interacting with an area of ​​the DDI 330.

[0505] Referring now to P-EID 320''', P-EID 320''' is an external device that communicates with and charges implantable medical device MD. P-EID 320''' is remotely controlled by an HCP to read information from implantable medical device MD, control the operation of implantable medical device MD, control the charging of implantable medical device MD, and can adjust settings for software running on implantable medical device MD's controller 300, for example, by adding or deleting predefined program steps and / or by selecting predefined parameters within limited ranges. Like remote controller 320'', P-EID 320''' can be configured to communicate with implantable medical device MD using BT or UWB communication. Similar to the remote control 320'', a combination of UWB wireless communication and BT can also be used to enable location of the P-EID 320'' as a way of establishing that the P-EID 320'' is in a location that the implanted medical device MD and / or patient and / or HCP can recognize, such as being in direct proximity to the correct patient and / or correct medical device MD. Similar to the remote control 320'', in embodiments where a combination of BT and UWB technology is used, UWB technology can be used for location-based authentication of the P-EID 320'', while communication and / or data transfer can occur using BT. The P-EID 320'' includes a wireless transceiver 328 for communication and a wireless transmitter 325 configured to wirelessly transmit energy in the form of a magnetic field to a wireless receiver 395 of the implantable medical device MD configured to receive energy in the form of a magnetic field and convert the energy wirelessly to electrical energy for storage in the implantable energy storage unit 40 and / or consumption in an energy consumer (e.g., operating device, controller 300) of the implantable medical device MD. The magnetic field generated at the P-EID and received at the implantable medical device MD is referred to as the “charging signal.” In addition to enabling wireless transfer of energy from the P-EID to the implantable medical device MD, the charging signal may also function as a communication means.For example, variations in transmission frequency and / or signal amplitude can be used as a signaling mechanism to enable one-way communication from the P-EID to the implantable medical device MD, or two-way communication between the P-EID and the implantable medical device MD. The charging signal in the embodiment shown in FIG. 20 is a signal in the 120-140 kHz range, and the communication follows a proprietary communication signal protocol, i.e., is not based on an open standard. In other embodiments, Bluetooth can be combined with communication using the charging signal, or communication using the charging signal can be combined with UWB signals.

[0506] Similar to the remote control 320'', the UWB signal can also be used as a wake-up signal for the controller 300 or BT transceiver in some embodiments, allowing the BT transceiver in the implantable medical device MD to be turned off when not in use, eliminating the risk of BT interception or the risk of BT communications hacking the controller 300 of the implantable medical device MD. Alternatively, the charging signal can be used as a wake-up signal for the BT, since it does not travel very far. Also, as a location-based authentication measure, the effect of the charging signal or RSSI can be evaluated by the controller 300 in the implantable medical device MD to establish that the transmitter is within a defined range. In a BT / UWB combination, UWB can also be used to transmit data. In some embodiments, the UWB and / or charging signal can be used to transmit portions of data, such as sensitive portions of data, or to transmit keys to unlock encrypted communications sent by the BT.

[0507] UWB can also be used to wake up the transmission of charging signals, initiate wireless energy transfer, and initiate communication using charging signals. The energy transmission signals are much more effective than regular wireless communication signals, so the energy transmission signals cannot be active all the time.

[0508] The P-EID 320'' communicates with the HCP over the Internet via secure communications, such as a VPN. Communications between the HCP and the P-EID 320'''' are preferably encrypted. Communications from the HCP to the implantable medical device MD may be performed using end-to-end encryption, in which case the communications are not decrypted by the P-EID 320''''. In such an embodiment, the P-EID 320'''' acts as a router that simply passes encrypted communications from the HCP to the controller 300 of the implantable medical device MD. This solution further improves security by reducing the risk of unencrypted signals being intercepted by unauthorized devices, since only the HCP and the implantable medical device MD have the keys to decrypt the information.

[0509] When the implantable medical device MD is remotely controlled and / or updated by an HCP via P-EID 320''', HCP dedicated device (DD) 332 displays an interface in which predefined program steps or setpoints are presented to the HCP. The HCP provides input to HCP DD 332 by selecting program steps, changing setpoints and / or values, or changing the order in which predefined program steps are executed. Instructions / parameters entered into HCP DD 332 for remote operation are routed to P-EID 320''' via DDI 330 in the embodiment shown in FIG. 20. DDI 330 may store instructions for a period of time in a created package of instructions for later forwarding to P-EID 320'''. An additional layer of encryption may also be provided to the package by DDI 330. The additional layer of encryption may be one that is decrypted by P-EID 330 or may be one that can only be decrypted by controller 300 of implantable medical device MD, thereby reducing the risk of unencrypted instructions or packages being intercepted by unauthorized devices. The instructions / parameters are then provided to P-EID 320'', which loads the instructions / parameters into implantable medical device MD during the next charge / energy transfer using any of the signal transfer means (wireless or conductive) disclosed herein.

[0510] The healthcare professional EID (HCP EID) 320′ has the same functionality as the P-EID 320″ and can communicate with the implantable medical device MD in the same alternative ways (and combinations of alternative ways) as the P-EID 320″. However, in addition, the HCP EID 320′ also allows the HCP to freely reprogram the implantable medical device MD's controller 300, including replacing the entire program code running on the controller 300. The HCP EID 320′ is always in the hands of the HCP, and thus the idea is that any updates to program code or retrieval of data from the implantable medical device MD using the HCP EID 320′ are performed in the HCP's presence (i.e., not remotely). The physical presence of the HCP is an additional layer of security for these updates that may be critical to the functionality of the implantable medical device MD.

[0511] In the embodiment shown in FIG. 20 , the HCP communicates with the HCP EID 320′ using an HCP Dedicated Device 332 (HCP DD), which is a display device that controls the HCP EID 320′ and forms a control interface for communicating with the HCP EID 320′. Because the HCP EID 320′ always physically resides in the HCP's clinic, communications between the HCP EID 320′ and the HCP DD 332 do not need to be transmitted over the Internet. Instead, the HCP DD 332 and the HCP EID 320′ can communicate using one or more of Bluetooth, a proprietary wireless communication channel, and a wired connection. Programming changes are then transmitted directly to the implantable medical device MD via the HCP EID 320′. Inputting commands into the HCP DD 332 for direct operation by the HCP EID 320′ is the same as inputting commands directly into the HCP EID 320′, and the HCP EID 320′ forwards the commands directly to the implantable medical device MD.

[0512] In the embodiment shown in FIG. 20, both the patient and HCP have a combined hardware key 333′, 333″. The combined key 333′, 333″ consists of hardware components: a unique circuit (providing the highest level of security), a wireless NFC transmitter 339 for transmitting a specific code (providing a medium level of security), and a printed QR code 344 for optical recognition of the card (providing the lowest level of security).

[0513] The patient key 333' in the embodiment shown in FIG. 20 is in the form of a key card having an interface for communicating with the P-EID 320'' so that the key card can be inserted into a key card slot in the P-EID 320''. An NFC transmitter 339 and / or a printed QR code 344 can be used as a means to access the control interface 334i of the display device 334. Additionally, the display device 334 may require a pin code and / or biometric input such as facial or fingerprint recognition.

[0514] In the embodiment shown in FIG. 20, the HCP's key 333'' is in the form of a key card having an interface for communicating with the HCP-EID 320' such that the key card can be inserted into a key card slot on the HCP-EID 320'. An NFC transmitter 339 and / or a printed QR code 344 can be used as a means to access the control interface of the HCP DD 332. Additionally, the HCP DD 332 may require a pin code and / or biometric input such as facial or fingerprint recognition.

[0515] However, in alternative embodiments, the hardware key solution may be replaced with a two-factor authentication solution, such as a digital key combined with a PIN code or biometric input (such as facial and / or fingerprint recognition).

[0516] In the embodiment shown in FIG. 20 , communications over the internet are performed via a dedicated data infrastructure (DDI) 330 running on a cloud service. The DDI 330 handles communications between the HCP DD 332 and the P-EID 320′″, between the HCP and the remote controller 320′″, between the HCP and the patient's display device 334, and between the HCP and the ancillary device 336 (tools for following up on the patient's treatment, such as a weight scale in the obesity treatment example or a sphygmomanometer in the blood pressure treatment example). In some embodiments, the HCP DD 332 also handles communications between the patient's display device 334 and the remote controller 335. In all examples, communications from the HCP to the P-EID 320″, remote control 320″, patient's display device 334, and ancillary device 336 may be performed using end-to-end encryption. In embodiments using end-to-end encryption, communications cannot be decrypted by the DDI 330. In such embodiments, the DDI 330 simply acts as a router that passes encrypted communications from the HCP to the various devices. This solution further improves security as the keys to decrypt the information reside only in the HCP and the device sending or receiving the communication, reducing the risk of unencrypted signals being intercepted by unauthorized devices.

[0517] In addition to acting as a communications intermediary or router, the DDI 330 collects implanted medical device (MD) data, treatment data, and patient data. Data may be collected in encrypted, anonymized, or open formats. The format of the collected data may depend on the confidentiality of the data or the source from which it is collected. In the embodiment shown in FIG. 20 , the DDI 330 transmits a questionnaire to the patient's display device 334. The questionnaire may consist of questions for the patient related to the patient's general health, the patient's lifestyle, or specifically related to the treatment provided by the implanted medical device (MD) (e.g., a visual analog scale for measuring pain). The DDI 330 may compile and / or combine input from multiple sources and communicate such input to the HCP, who can use the provided information to create instructions for the various devices that are sent back via the DDI 330. Data collection performed by the DDI 330 may also be in the form of a log to enable back-tracing of all communications between units in the system. Logging communications ensures that all changes to software or software settings are tracked, as well as the frequency and operation of the implanted medical device. Tracking communications allows the DDI330 or HCP to track treatment and act if something in the communications indicates that the treatment is not delivering the intended results, or if there appears to be an issue with one of the components in the system.

[0518] In the specific embodiment shown in FIG. 20 , the wireless connections between the different units are as follows: wireless connection 411 between auxiliary device 336 and DDI 330 is based on Wi-Fi or a mobile telecommunication system, and wireless connection 411 between auxiliary device 336 and patient display device 334 is based on BT. wireless connection 412 between patient display device 334 and DDI 330 is based on Wi-Fi or a mobile telecommunication system. wireless connection 413 between patient display device 334 and remote controller 320″ is based on BT. wireless connection 414 between remote controller 320″ and implantable medical device MD is based on BT and UWB. wireless connection 415 between remote controller 320″ and DDI 330 is based on Wi-Fi or a mobile telecommunication system. wireless connection 416 between P-EID 320′″ and implantable medical device MD is based on BT, UWB and charging signals. The wireless connection 417 between the P-EID 320''' and the DDI 330 is based on Wi-Fi or mobile telecommunication systems. The wireless connection 418 between the HCP-EID 320'' and the implantable medical device MD is based on BT, UWB and charging signals. The wireless connection 419 between the P-EID 320'' and the HCP DD 332 is based on BT. The wireless connection 420 between the HPC-EID 320' and the DDI 330 is based on Wi-Fi or mobile communication systems. The wireless connection 421 between the HPC DD 332 and the DDI 330 is based on Wi-Fi or mobile communication systems. The wireless connection 422 between the HCP-EID 320' and the HCP DD 332 is based on BT.

[0519] However, the wireless connection specifically described in the embodiment shown in FIG. 20 may be replaced or supplemented by a wireless connection based on radio frequency identification (RFID), near field communication (NFC), Bluetooth, Bluetooth low energy (BLE), or wireless local area network (WLAN). The mobile communication method may be, for example, 1G, 2G, 3G, 4G, or 5G. The wireless connection may further be based on modulation techniques such as amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), or quadrature amplitude modulation (QAM). The wireless connection may further comprise techniques such as time division multiple access (TDMA), frequency division multiple access (FDMA), or code division multiple access (CDMA). The wireless connection may also be based on infrared (IR) communication. The wireless connection may be characterized by radio frequencies in the high frequency band (HF), very high frequency band (VHF), ultra high frequency band (UHF), and essentially any other band applicable to electromagnetic wave communication. The wireless connection may also be based on ultrasonic communication, to give at least one example that does not rely on electromagnetic waves.

[0520] 20 has been described primarily in terms of wireless communication, wireless communication between any of the external devices may be replaced with wired communication. Also, some or all of the wireless communication between the external device and the implantable medical device MD may be replaced with conductive communication (as will be further described with reference to FIGS. 16A to 16C) that uses part of the human body as a conductor.

[0521] Communication and Housing As previously discussed in this application, communication with a medical implant must be reliable and secure. To this end, it is desirable to provide a standalone device, such as an external remote controller for the medical implant (e.g., as illustrated as 320 in FIG. 20 ), to prevent other programs or applications from running on the same device that could interfere with or corrupt communication with the medical implant. However, smartphones or tablets (e.g., as illustrated as 334 in FIGS. 119a-119h) have become a part of everyday life for most people. This means that we almost always have our smartphones on hand. For this reason, it would be convenient for patients to use their smartphones to communicate directly with their medical implants, eliminating the need to carry an additional standalone device. However, because smartphones often run many other applications, they do not meet the requirements for being a secure and reliable communication tool free from interference from other communications. Therefore, it is desirable to separate the tasks of providing secure communication between the external device and the implant from those of communication with the Internet and providing a familiar and intuitive user interface. To this end, external devices are provided that provide secure communication and tamper-resistant software and hardware, and display devices that allow for intuitive and easy use. In the embodiment described with reference to Figures 21 to 25, a device that meets these combined needs is described in the form of a stand-alone remote control external device integrated into a housing unit 320'' that can be connected to a smartphone or other display device 334 such as a smartwatch or tablet.

[0522] FIG. 21 illustrates the housing unit 320″ in an elevated perspective view from the left, and FIG. 22 illustrates the housing unit 320″ in a plan view from the left. In the embodiment illustrated in FIG. 21 , the housing unit 320″ has a rectangular shape with rounded edges and a height 1521 that is 1.5 times or greater than its width 1522. The housing unit 320″ includes a recess 1525 configured to receive a display device 334 in the form of a smartphone, the display device 334 configured to fit into the housing unit 320″ to mechanically and removably connect the display device 334 to the housing unit 320″. The boundary of the recess 1525 in the housing unit 320″ forms an edge 1528 configured to surround the display device 334 when the display device 334 is inserted into the recess 1525. In the embodiment illustrated in FIG. 21 , the recess 1525 has a depth 1526 configured to allow the display device 334 to be fully inserted into the recess 1525. As such, depth 1526 of recess 1525 exceeds depth 1531 of display device 334. In the embodiment shown in FIGS. 21 and 22, the edge is relatively thin and has a width 1527 that is in the range of 1 / 8 to 1 / 100 of the width of display device 334, and as such, housing unit 320'' has a width that is in the range of 1.02 to 1.25 times the width 1522 of housing unit 320''. Similarly, housing unit 320'' has a height 1521 that is in the range of 1.01 to 1.25 times the height 1521 of display device 334. In the embodiment shown in FIGS. 120-22, edge 1528 is configured to sandwich display device 334, thereby mechanically securing display device 334 within housing unit 320''. The minimum bounding box of the housing unit 320 ″ and the display device 334 when mechanically connected is not 10% wider, 10% longer, or 100% taller than the minimum bounding box of the display device 334 .

[0523] To form the gripping fixation, the edge of the housing unit 320" is made from a resilient material that provides tension between the edge 1528 and the display device 334, holding the display device 334 in place. The resilient material can be a resilient polymer material or a thin sheet of resilient metal. To further secure the display device 334 within the housing unit 320", the inner surface of the edge 1528 can optionally define a recess or protrusion (not shown) that corresponds to a recess or protrusion on the outer surface of the display device 334. The edge 1528 can also define a recessed portion to form a mechanical fixation between the housing unit 320" and the display device 334 with a snap-lock type fastener.

[0524] In the embodiment shown in FIGS. 21 and 22 , the housing unit 320″ functions as a remote control for communicating with the implanted medical device, including receiving information from the implanted medical device and providing instructions and updates to the implanted medical device. The information may be information related to the status of the implanted medical device, including any functional parameters of the implanted medical device, or may be related to the patient's condition, including any physiological parameters related to the patient's body (as further described in other sections of this disclosure). For purposes of providing input to the implanted medical device and controlling and updating the functions of the housing unit 320″, the housing unit 320″ includes a control interface consisting of switches in the form of control buttons 335. The control buttons 335 are configured to be used when an external device is disconnected from the display device 334. The control interface further includes a display 1505 that is smaller and typically less sophisticated than the display of the display device 334. In an alternative embodiment, the control buttons 335 and the display 1505 are integrated into a single touch-responsive (touchscreen) display on which the control buttons may be displayed. In the embodiment shown in FIGS. 21 and 22 , one of the control buttons 335 is a control button for activating the implantable medical device, and the other of the control buttons 335 is a control button for deactivating the implantable medical device. When the display device 334 is attached to the housing unit 320″, the control buttons 335 and the display are covered by the display device 334 and are inoperative in such a state. In the embodiment shown in FIGS. 21 and 22 , the housing unit 320″ is configured to transmit information for displaying a user interface to the display device 334, and the display device 334 is configured to receive input from the patient for communication with the implantable medical device and to transmit a signal based on the received input to the housing unit 320″. The input may be a command for changing the operational state of the implantable medical device. The display device 334 includes a touch screen configured to display a user interface and receive input from the patient.The display of display device 334 may be comprised of one or more OLED or IPS LCD elements. When display device 334 is connected to housing unit 320'', display device 334 is configured to display a control interface used to communicate with housing unit 320'', i.e., to provide input to and receive information from housing unit 320''. Input provided to housing unit 320'' is then relayed to the implanted medical device; similarly, information communicated from the implanted medical device to housing unit 320'' may be relayed or displayed on display device 334. Having an external device consisting of the combination of housing unit 320'' that constitutes a communication means for communicating with the implanted medical device and display device 334 that essentially functions only as an input / output device connected to housing unit 320'' allows for secure communication between housing unit 320'' and display device 334 that is out of reach of the display device's 334's internet connection, making it more difficult for an external attacker to access any of the critical communication portions of housing unit 320''. Communication between the housing unit and the display device 334 is highly restricted, and the only communication permitted from the display device 334 to the housing unit 320'' is input from the patient or medical professional and authentication parameters created by an authentication application running on the display device 334. The authentication application running on the display device 334 may be a number generating authentication device or a biometric authentication device to authenticate the patient or medical professional, and the authentication parameters may be parameters derived from a facial image or fingerprint, for example. In the opposite direction, i.e., from the housing unit 320'' to the display device 334, communication may be limited to only that necessary to display information and / or a graphical user interface on the display device 334.The communication restrictions can be based, for example, on the size of the communication package or the frequency with which the communication occurs, thereby reducing the risk of an unauthorized person making multiple attempts to extract information from or transfer information to the handheld device.

[0525] In the embodiment shown with reference to FIGS. 21 and 22 , the housing unit 320″ comprises a first communication unit that provides a wireless connection 413 to the display device 334. The wireless connection 413 is based on NFC in the embodiment shown in FIGS. 21 and 22 , but in alternative embodiments may be based on Bluetooth or any other communication path disclosed herein. The housing unit 320″ further comprises a second communication unit that provides a wireless connection with the implanted medical device. The wireless communication between the housing unit 320″ and the implanted medical device is based on Bluetooth in the embodiment shown in FIGS. 21 and 22 , but in alternative embodiments may be based on NFC or UWB or any other communication path disclosed herein.

[0526] As described above, in the embodiment shown in FIGS. 21 and 22 , wireless communication between housing unit 320″ and display device 334 is based on NFC, and wireless communication between housing unit 320″ and display device 334 is based on Bluetooth. Thus, a first communication unit of housing unit 320″ is configured to wirelessly communicate with display device 334′ using a first communication frequency, and a second communication unit of housing unit 320″ is configured to wirelessly communicate with the implantable medical device using a second, different communication frequency. To this end, the first communication unit of housing unit 320″ comprises a first antenna configured for NFC-based wireless communication with display device 334, and the second communication unit comprises a second antenna configured for Bluetooth-based wireless communication with the implantable medical device. The first and second antennas may be wire-based antennas or substrate-based antennas. Thus, the first communication unit is configured to wirelessly communicate with display device 334 at a first frequency, and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second, different communication frequency. Additionally, the first communication unit of the housing unit 320' is configured to wirelessly communicate with the display device 334 using a first communication protocol (the NFC communication protocol), and the second communication unit is configured to wirelessly communicate with the implantable medical device using a second communication protocol (the Bluetooth communication protocol). Because the first and second communication protocols are different, security mechanisms may be built into the electronics and / or software that enable transfer from the first communication protocol to the second communication protocol, providing an additional layer of security.

[0527] In alternative embodiments, the second communication unit can be configured to wirelessly communicate with the implantable medical device using electromagnetic waves at frequencies below 100 kHz, preferably below 40 kHz. Thus, the second communication unit can be configured to communicate with the implantable medical device using "very low frequency" (VLF) communications. Because VLF signals have the ability to penetrate the titanium housing of the implant, the electronics of the implantable medical device can be fully enclosed within the titanium housing. In further embodiments, the first and second communication units can be configured to communicate via an RFID-type protocol, a WLAN-type protocol, a BLE-type protocol, a 3G / 4G / 5G-type protocol, or a GSM-type protocol.

[0528] In yet other alternative embodiments, it is contemplated that the mechanical connection between the housing unit 320'' and the display device 334 constitutes an electrical connection for forming a wire-based communication channel between the housing unit 320'' and the display device 334. The electrical connection may also be configured to transfer electrical energy from the display device 334 to the housing unit such that the housing unit 320''' may be powered or charged by the display device 334. A wired connection is more difficult for unauthorized entities to access than an NFC-based wireless connection, thereby making communications between the housing unit 320'' and the display device 334 more secure.

[0529] In the embodiment shown with reference to Figures 21 and 22, the display device 334 comprises a first communication unit providing a wireless connection 413 with the housing unit 320" based on NFC. The display device 334 further comprises a second communication unit providing a wireless connection with a further external device and / or with the Internet. The second external device may be located far away, for example in a hospital or at a location where a medical professional practices. The wireless communication between the display device 334 and the further external device is based on WiFi in the embodiment shown in Figures 21 and 22, but in alternative embodiments may be based on Bluetooth, for example.

[0530] As described above, in the embodiment shown in FIGS. 21 and 22 , wireless communication between the display device 334 and the housing unit 320″ is based on NFC, and wireless communication between the display device and the further external unit is based on WiFi. Thus, a first communication unit of the display device 334 is configured to wirelessly communicate with the housing unit 320″ using a first communication frequency, and a second communication unit of the display device 334 is configured to wirelessly communicate with the further external device using a second, different communication frequency. To this end, the first communication unit of the display device 334 comprises a first antenna configured for NFC-based wireless communication with the housing unit 320″, and the second communication unit comprises a second antenna configured for WiFi-based wireless communication with the further external device. The first and second antennas may be wire-based antennas or substrate-based antennas. Thus, the first communication unit is configured to wirelessly communicate with the housing unit 320″ at a first frequency, and the second communication unit is configured to wirelessly communicate with the further external device using a second, different communication frequency. Additionally, the first communication unit of the display device 334 is configured to communicate wirelessly with the housing unit 320'' using a first communication protocol (the NFC communication protocol), and the second communication unit is configured to communicate wirelessly with a further external device using a second communication protocol (the WiFi communication protocol). The first and second communication protocols are different, which adds an additional layer of security as security mechanisms may be built into the electronics and / or software that enable transfer from the first communication protocol to the second communication protocol.

[0531] In alternative embodiments, the second communication unit of the display device 334 may be configured to communicate with a further external device by means of a WLAN type protocol, or a 3G / 4G / 5G type protocol, or a GSM type protocol.

[0532] 21 and 22, the communication range of the first communication unit of housing unit 320'' is less than the communication range of the second communication unit of housing unit 320', such that the communication range between housing unit 320'' and the medical implant may be longer than the communication range between housing unit 320'' and display device 334. In the embodiment shown in FIGS. 21 and 22, the communication range of the first communication unit may be constrained to a length less than five times the longest dimension of the minimum bounding box of display device 334, or more precisely, to a length less than three times the longest dimension of the minimum bounding box of display device 334.

[0533] In the embodiment shown in FIGS. 21 and 22 , communication between the housing unit 320″ and the display device 334 is enabled only when the housing unit 320″ is connected to the display device 334. That is, at least one of the housing unit 320″ and the display device 334 is configured to enable communication between the housing unit 320″ and the display device 334 based on the distance between the housing unit 320″ and the display device 334. Alternatively, the housing unit 320″ and / or the display device 334 may include a sensor configured to estimate whether the housing unit 320″ is attached to the display device 334, such as a mechanically actuated switch or a photoresistive sensor that provides a sensor input when the housing unit 320″ and the display device 334 are mechanically connected to one another. A signal from the at least one sensor can then be used to enable use of a communication unit configured to communicate with the display device 334.

[0534] In the embodiment shown in FIGS. 21 and 22, communication between the housing unit 320'' and the implantable medical device is only possible based on the distance between the housing unit 320'' and the implantable medical device. In the embodiment shown in FIGS. 21 and 22, the distance is preferably less than 20 times the longest dimension of the smallest bounding box of the display device, more specifically less than 10 times the longest dimension of the smallest bounding box of the display device. The distance between the housing unit 320'' and the medical implant can be measured using electromagnetic waves or acoustic waves. The process of measuring the distance may consist of triangulation.

[0535] In the embodiment shown in FIGS. 21 and 22, the second communication unit of display device 334 must be disabled to allow communication between display device 334 and housing unit 320″, and the second communication unit of display device 334 must be disabled to allow communication between housing unit 320″ and the medical implant. The second communication unit of housing unit 320″ must be disabled to allow communication between housing unit 320″ and the medical implant.

[0536] In the embodiment shown in FIGS. 21 and 22, housing unit 320" further comprises an encryption unit configured to encrypt communications received from display device 334 before transmitting the communications to the implantable medical device. The encryption unit may be based, for example, on one of the following algorithms: AES, Blowfish, DES, Kalyna, Serpent, or Twofish. For purposes of handling communications, I / O, and encryption, housing unit 320" comprises a processor, which may be a general-purpose microprocessor and / or an instruction set processor and / or an associated chipset and / or a special-purpose microprocessor such as an ASIC (Application Specific Integrated Circuit). The processor also comprises a memory for storing instructions and / or data.

[0537] 23 and 24 show an embodiment of an external unit similar to the embodiment described with reference to FIGS. 21 and 22. The difference is that in the embodiment of FIGS. 23 and 24, the housing unit 320" does not sandwich the display device 334. Instead, the housing unit includes two magnets 1510 for magnetically securing the display device 334 to the housing unit 320". In alternative embodiments, it is also contemplated that the external unit may be comprised of an intermediate portion that is fixedly secured to the housing unit to provide a detachable connection with the display device 334. Alternatively, the intermediate portion may be fixedly secured to the display device 334 and provide a detachable connection with the housing unit 320".

[0538] FIG. 25 shows a system overview of an external device (which may be the external device of the embodiments described with reference to FIGS. 21 and 22 or the external device of the embodiments described with reference to FIGS. 23 and 24). Housing unit 320″ is connected to display device 334. A wireless connection 413 is provided between housing unit 320″ and display device 334, and a further wireless connection 413 is provided between housing unit 320″ and implantable medical device MD, allowing the housing unit to send instructions and updates to, and receive information, parameters (such as sensor values), and alarms from, the implantable medical device MD. Communication between the external device and the implantable medical device MD is further described elsewhere in this disclosure.

[0539] Surface Coating 26 shows an implantable medical device or implant MD comprising a body 510, an implant surface 520, and a coating 530 disposed on surface 520. Coating 530 can be configured to have antimicrobial properties. Depending on the application of the implantable medical device, one or both of these effects may be advantageous. Coating 530 can be disposed on surface 520 to shield surface 520 from direct contact with a host body into which the implantable medical device MD is inserted.

[0540] Coating 530 may include at least one layer of a biological material. Coating 530 may be composed of an anti-thrombogenic material. Coating 530 may also be composed of an anti-bacterial material. Coating 530 may be chemically attached to surface 520.

[0541] FIG. 27 shows an exemplary implantable medical device or implant MD having a body 510 and a surface 520. The implantable medical device MD comprises multiple coatings 530a, 530b, and 530c disposed on the surface. The implant MD can comprise any number of coatings, and the specific embodiment of FIG. 6 discloses three layers of coatings 530a, 530b, and 530c. A second coating 530b is disposed on the first coating 530a. The different coatings 530a, 530b, and 530c can be composed of different materials with different characteristics to prevent either fibrin sheath formation or bacterial collection on the surface 520. As an example, the first coating 530a can be composed of a layer of perfluorocarbon chemically attached to the surface. The second coating 530b can be composed of a liquid perfluorocarbon layer disposed on the first coating 530a.

[0542] The mentioned coatings can consist of any substance or combination of substances. The coatings may include anticoagulants such as: apixaban, dabigatran, dalteparin, edoxaban, enoxaparin, fondaparinux, heparin, rivaroxaban, warfarin, etc.

[0543] The coating may also contain medicines or substances that are so-called antiplatelet agents. These may include aspirin...

Claims

1. 1. A system for treating a patient having a disorder relating to the patient's intestine (100), comprising a plurality of electrical stimulation devices (10), each of said electrical stimulation devices (10) comprising one or more electrodes (11) for electrically stimulating muscle or nerve tissue of the intestine (100), and a wireless energy receiver (R) configured to wirelessly receive energy for stimulating the muscle or nerve tissue.

2. 2. The system of claim 1, comprising one or more wireless energy transmitters (T), wherein one wireless energy transmitter is configured to transmit energy to all of the electrical stimulation devices (10), or at least one of the plurality of wireless energy transmitters (T) is configured to transmit energy to some of the electrical stimulation devices (10).

3. 3. The system of claim 2, wherein the wireless energy receiver (R) of each of the electrical stimulation devices (10) includes a secondary coil, and at least one of the wireless energy transmitters (T) includes a primary coil (18) configured to induce a voltage in some or all of the secondary coils of the electrical stimulation devices (10).

4. 10. The system of claim 1, including a separate wireless energy transmitter for each one of the electrical stimulation devices (10), configured to transmit energy to each one of the electrical stimulation devices (10).

5. 5. The system of claim 4, wherein the wireless energy receiver (R) of each of the electrical stimulation devices (10) includes a secondary coil, and each of the individual wireless energy transmitters (T) includes a primary coil (18A, 18B) configured to transmit energy to the secondary coil of each of the electrical stimulation devices (10).

6. Each of the electrical stimulation devices (10) has an internal control unit (C Ｉ 10. The system of claim 1, comprising:

7. Internal Controller (C Ｉ 7. The system of claim 6, wherein the electrode control data for controlling stimulation of muscle or nerve tissue is wirelessly received via the wireless energy receiver (R).

8. Internal Controller (C Ｉ ) is an external controller (C Ｅ ), or remote controller (C Ｒ 7. The system of claim 6, wherein the individual codes are individually addressable by

9. Internal Controller (C Ｉ an external controller (C) configured to communicate wirelessly with the Ｅ 10. The system of claim 6, comprising:

10. External controller (C Ｅ ) and an implantable external controller (C) configured to be implanted in the patient's body. Ｅ 10. The system of claim 9, wherein

11. External controller (C Ｅ ) is controlled from outside the patient's body by the internal controller (C Ｉ 10. The system of claim 9, wherein the remote controller is configured to communicate with a

12. The external controller (C) is implanted from outside the patient's body. Ｅ ) and a remote controller (C Ｒ 11. The system of claim 10, comprising:

13. Remote controller (C Ｒ ) is an implantable external controller (C Ｅ 13. The system of claim 12, configured to wirelessly communicate with a

14. Remote controller (C Ｒ 12. The system of claim 11, wherein the device is configured to be attached to the skin of the patient.

15. 2. The system of claim 1, wherein the electrodes (11) of the electrical stimulation device (10) are configured to electrically stimulate muscle or nerve tissue sufficient to cause the muscles of the intestine (100) to contract to an extent that the intestine (100) contracts.

16. 16. The system of claim 15, wherein the electrical stimulation device (10) forms part of an electrical stimulation pump configured to propel bowel contents downstream through the patient's bowel (100).

17. 2. The system of claim 1, wherein the system is configured to be applied to a reservoir portion of the intestine formed from surgically modified intestine (100) cut along the line of mutual contact of laterally adjacent portions of a bent portion of the intestine (100), with the upper and lower halves of the cut intestine (100) joined to form the intestinal wall of the reservoir portion.

18. 2. The system of claim 1, wherein at least the electrodes (11) of the electrical stimulation device (10) are configured to be implanted in a surgically created fold (102) of the patient's intestine (100).

19. 2. The system of claim 1, configured to electrically stimulate, by electrodes (11) of the electrical stimulation device (10), muscle or nerve tissue in a region of the intestine (100) contracted by at least one mechanical or hydraulic contraction device to increase blood flow through the tissue of the intestine (100).

20. 20. The system of claim 19, wherein the electrical stimulation of muscle or nerve tissue to increase blood flow through the tissue of the intestine (100) is adjustable at a low level that is not sufficient to contract the intestine (100).

21. 2. The system of claim 1, wherein the one or more electrodes (11) include an electrode portion at least partially covered by a dielectric material configured to form a dielectric-tissue interface with tissue, thereby reducing the faradaic portion of charge transfer mechanisms on the interface.

22. 10. An artificial sphincter configured, when implanted, to act on the wall of a patient's intestine (100) to restrict the flow of intestinal contents through the intestine (100), the artificial sphincter comprising the system of claim 1.

23. 10. A jejunal device configured, when implanted, to act on the wall of a patient's intestine (100) to expel intestinal contents contained therein from the intestine (100), the jejunal device comprising the system of claim 1.

24. 24. A method of using a system according to any one of claims 1 to 21, or an artificial sphincter according to claim 22, or a jejunal device according to claim 23, comprising the step of electrically stimulating, by means of electrodes (11) of said electrical stimulation device (10), the muscle tissue of a region (100) of the intestine that has been constricted by at least one mechanical or hydraulic constriction device sufficiently to increase blood flow through the intestinal tissue.

25. 25. The method of claim 24, comprising adjusting the electrical stimulation of muscle tissue to increase blood flow through the intestinal tissue at a low level that is not sufficient to cause the intestine to contract.

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