EP4395704A1 - Vorrichtung und verfahren zur urinkontrolle - Google Patents
Vorrichtung und verfahren zur urinkontrolleInfo
- Publication number
- EP4395704A1 EP4395704A1 EP22772432.5A EP22772432A EP4395704A1 EP 4395704 A1 EP4395704 A1 EP 4395704A1 EP 22772432 A EP22772432 A EP 22772432A EP 4395704 A1 EP4395704 A1 EP 4395704A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- patient
- implantable
- constriction
- urinary bladder
- urine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/042—Urinary bladders
Definitions
- a method of implanting an implantable pumping device comprises the steps of making an incision in the body of the patient, for accessing the urinary bladder. Dissecting a portion of the urinary bladder. Inserting an implantable pumping device into the body of the patient. Placing the implantable pumping device in connection with the urinary bladder, such that the implantable pumping device can constrict the urinary bladder to restrict the flow of fluid therethrough and to evacuate urine from the urinary bladder.
- the outer casing forms a complete enclosure, such that electromagnetic waves received and transmitted by the first portion must travel through the casing.
- the second portion comprises an outer casing made from titanium.
- the electromagnetic waves comprise wireless energy and/or wireless communication.
- the casing of the first portion forms a complete enclosure such that the entirety of the outer surface of the first portion is covered by the casing.
- the length direction extends from an interface between the connecting portion and the second portion towards an end of the second portion.
- the length direction extends in a direction substantially perpendicular to the central extension axis.
- a method of implanting a powered medical device comprises placing a second portion of an implantable energized medical device between a peritoneum and a layer of muscular tissue of the abdominal wall.
- the method further comprises placing a first portion of the implantable energized medical device between the skin of the patient and a layer of muscular tissue of the abdominal wall.
- the first and second portions are configured to be connected by a connecting portion extending through at least one layer of muscular tissue of the abdominal wall.
- the method further comprises placing a body engaging portion of the powered medical device in connection with a tissue or an organ of the patient which is to be affected by the powered medical device.
- the method further comprises placing a transferring member, configured to transfer at least one of energy and force from the second portion to the body engaging portion, at least partially between a peritoneum and a layer of muscular tissue of the abdominal wall, such that at least 1/3 of the length of the transferring member is placed on the outside of the peritoneum.
- an external device configured for communication with an implantable medical device, when implanted in a patient.
- the external device comprises at least one first wireless transceiver configured for communication with the implantable medical device using a first network protocol, for determining a distance between the external device and the implantable medical device, and at least one second wireless transceiver configured for communication with the implantable medical device using a second network protocol, for transferring data between the external device and the implantable medical device.
- an implantable medical device configured for communication with an external device.
- the implantable medical device comprises at least one first wireless transceiver configured for communication with the external device using a first network protocol, for determining a distance between the external device and the implantable medical device, and at least one second wireless transceiver configured for communication with the external device using a second network protocol, for transferring data between the external device and the implantable medical device.
- a patient external device configured for communication with an implantable medical device, when implanted in a patient, is provided.
- the patient external device comprises a wireless communication unit configured for wireless transmission of control commands to the implantable medical device and configured for wireless communication with a patient display device, and a computing unit configured for running a control software for creating the control commands for the operation of the implantable medical device.
- the computing unit is configured to transmit a control interface as a remote display portal to a patient display device configured to display the control interface to a user, receive user input from the patient display device, and transform the user input into the control commands for wireless transmission to the implantable medical device.
- a patient display device for communication with a patient remote external device for communication with an implantable medical device.
- the patient display device comprises a wireless communication unit configured for wirelessly receiving an implant control interface as a remote display portal from the patient remote external device and configured for wirelessly transmitting implant control user input to the patient remote external device, a display for displaying the received implant control interface, and an input device for receiving implant control input from the user.
- the computing unit is configured for running a control software for creating the control commands for the operation of the implantable medical device, transmitting a control interface to the patient display device, receiving implant control user input generated at the patient display device, from the server, and transforming the user input into the control commands for wireless transmission to the implantable medical device.
- the patient display device comprises a first log-in function and a second log-in function, wherein the first log-in function gives the user access to the first application and wherein the first and second log-in function in combination gives the user access to the second application.
- the first log-in function may be configured to use at least one of a password, pin code, fingerprint, voice and face recognition.
- a second log-in function within the first application may be configured to use a private key from the user to authenticate, for a defined time period, a second hardware key of the patient external device.
- a communication system for enabling communication between a patient display device and an implantable medical device, when implanted, is provided.
- the patient display device comprises a wireless communication unit configured for wirelessly receiving an implant control interface as a remote display portal from the patient remote external device, the wireless communication unit further being configured for wirelessly transmitting implant control user input to the patient remote external device, a display for displaying the received implant control interface as a remote display portal, and an input device for receiving implant control input from the user.
- the patient display device is configured to run a first application for wireless communication with the server, and to run a second application for wireless communication with the patient remote external device for transmission of the implant control input to the remote display portal of the patient remote external device for the communication with the implantable medical device.
- the patient remote external device comprises a wireless communication unit configured for wireless transmission of control commands based on the implant control input to the implantable medical device and configured for wireless communication with the patient display device.
- a computer program product configured to run in a patient display device comprising a wireless communication unit, a display for displaying the received implant control interface as a remote display portal, and an input device for receiving implant control input from a user.
- a communication system for enabling communication between a patient display device, a patient external device, a server and an implantable medical device.
- the communication system comprises a server, a patient display device, a patient external device, and an implantable medical device.
- the patient display device comprises a wireless communication unit for wirelessly communicating with at least one of the patient external device and the server, a display, and an input device for receiving input from the user.
- the patient external device comprises a wireless communication unit configured for wireless transmission of control commands to the implantable medical device and configured for wireless communication with at least one of the patient display device and the server.
- the server comprises a wireless communication unit configured for wireless communication with at least one of the patient display device and the patient external device
- the implantable medical device comprises a wireless communication unit configured for wireless communication with the patient external device.
- the implantable medical device further comprises an encryption unit and is configured to: encrypt data destined for the server,
- a server for use in the communication system according to any one of the above aspects or below embodiments is provided.
- a patient display device for use in the communication system according to any one of the above aspects or below embodiments is provided.
- a patient external device for use in the communication system according to any one of the above aspects or below embodiments is provided.
- an implantable medical device for use in the communication system according to any one of the above aspects or below embodiments is provided.
- RECTIFIED SHEET (RULE 91) ISA/EP wireless transceiver configured for communication with a data infrastructure server, DDI, through a first network protocol.
- the system comprises a data infrastructure server, DDI, adapted to receive command from said HCP EID external device and to relay the received command without modifying said command to a patient EID external device
- the DDI comprises one wireless transceiver configured for communication with said patient external device, and a patient EID external device adapted to receive the command relayed by the DDI, further adapted to send this command to the implanted medical device, further adapted to receive a command from the HCP EID external device via the DDI to change said pre-programmed treatment settings of the implanted medical device, and further adapted to be activated and authenticated and allowed to perform said command by the patient providing a patient private key device adapted to be provided to the patient EID external device by the patient via at least one of: a reading slot or comparable for the patient private key device, a RFID communication
- the patient EID external device comprises at least one of a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact.
- the patient EID external device further comprises at least one wireless transceiver configured for communication with the implanted medical device through a second network protocol. Further, the implanted medical device is configured to treat the patient or perform a bodily function.
- the HCP private key device comprises at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device.
- the HCP EID external device is adapted to be involved in at least one of: receiving information from the implant, receiving information from a patient remote external device, actuating the implanted medical device, changing pre-programmed settings, and updating software of the implantable medical device, when implanted.
- the HCP EID external device is further adapted to be activated, authenticated, and allowed to perform said command also by the patient.
- a system configured for providing information from an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient.
- the system comprises at least one patient EID external device adapted to receive information from the implant, adapted to send such information further on to a server or dedicated data infrastructure, DDI, further adapted to be activated and authenticated and allowed to receive said information by the implanted medical device by the patient providing a private key.
- the system comprises a patient private key device comprising the private key adapted to be provided to the patient EID external device via at least one of: a reading slot or comparable for the patient private key device, a RFID communication or other close distance wireless activation communication or direct electrical connection.
- a system configured for changing preprogrammed treatment settings of an implantable medical device, when implanted in a patient, from a distant remote location in relation to the patient.
- the system comprises at least one health care provider, HCP, external device adapted to receive a command from the HCP to change said pre-programmed treatment settings of an implanted medical device.
- the HCP external device is further adapted to be activated and authenticated and allowed to perform said command by the HCP providing a HCP private key device adapted to be provided to an HCP EID external device via at least one of; a reading slot or comparable for the HCP private key device, a RFID communication or other close distance wireless activation communication.
- the HCP EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication or electrical direct contact.
- the HCP EID external device further comprises at least one wireless transceiver configured for communication with a patient EID external device, through a first network protocol.
- the system comprises the patient EID external device, the patient EID external device being adapted to receive command from said HCP external device, and to relay the received command without modifying said command to the implanted medical device.
- the patient EID external device comprises one wireless transceiver configured for communication with said patient
- At least one of the first and second constriction device is a hydraulic constriction device.
- the support element comprises a connection portion for connecting the support element to another support element for at least partially forming the surrounding structure.
- the implantable pumping device further comprises an electrode arrangement configured to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device.
- the first constriction device comprises a first curvature having a first radius adapted for a curvature of the urinary bladder.
- the second constriction device comprises a second curvature having a second radius adapted for a curvature of the urinary bladder.
- the first radius may be larger than the second radius.
- the electrically operable valve is a solenoid valve.
- the first interconnecting fluid conduit comprises a check valve, such that fluid can flow in a direction from the first operable hydraulic constriction element to the second operable hydraulic constriction element but not in a direction from the second operable hydraulic constriction element to the first operable hydraulic constriction element.
- the implantable pumping device further comprises a controller configured to receive a pressure sensor signal from at least one of the first and second pressure sensor, and control at least one of: the first electrically operable valve, the second operable valve and the hydraulic pump, on the basis of the received pressure sensor signal
- the implantable pumping device further comprises a second hydraulic pump, a second reservoir for holding hydraulic fluid, and a supporting reservoir conduit, fluidly connecting the second reservoir to the supporting operable hydraulic constriction element.
- the second hydraulic pump is configured to pump fluid from the second reservoir to the supporting operable hydraulic constriction element through the supporting reservoir conduit, for assisting in the constriction of the luminary organ.
- the implantable pumping device further comprises a third pressure sensor configured to sense the pressure in the supporting operable hydraulic constriction element.
- the second injection port is configured to be placed subcutaneously.
- the implantable pumping device further comprises a second injection port conduit fluidly connecting the second injection port to the second reservoir.
- the surrounding structure is substantially rigid.
- a major portion of the surrounding structure is made from a material having a modulus of elasticity in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa.
- the surrounding structure has a modulus of elasticity, radially, in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa.
- the curvature has a radius in the range 15mm - 60mm. [000147] According to an embodiment, the curvature has a radius in the range 20mm - 50mm. [000148] According to an embodiment, the supporting operable hydraulic constriction element is connected to the first operable hydraulic constriction element.
- the supporting operable hydraulic constriction element is less resilient than the first operable hydraulic constriction element.
- the first operable hydraulic constriction element comprises a lumen surrounded by a resilient wall and the supporting operable hydraulic constriction element comprises a lumen surrounded by a resilient wall, and wherein a portion of the resilient wall of the supporting operable hydraulic constriction element is thicker than a portion of the resilient wall of the first operable hydraulic constriction element.
- a portion of the resilient wall of the supporting operable hydraulic constriction element is more than 1,5 times thicker than a portion of the resilient wall of the first operable hydraulic constriction element.
- the modulus of elasticity of the second material is more than 2 times higher than the modulus of elasticity of the first material.
- At least one of: the first reservoir conduit comprises a check valve, and the second reservoir conduit comprises a check valve.
- the first hydraulic system comprises a first hydraulic pump.
- the second hydraulic system comprises a second hydraulic pump.
- the third hydraulic system comprises a third hydraulic pump.
- the fourth hydraulic system comprises a fourth hydraulic pump.
- the electrical stimulation signal comprises a build-up period of 0.01-2 s in which the amplitude is gradually increasing, a stimulation period of 1-60 s, and a stimulation pause of 0.01-60 s, wherein the electrical signal comprises a pulse frequency of 1-50 Hz and a pulse duration of 0.1-10 ms.
- At least one of the first and second hydraulic pump of the first constriction device and/or the second constriction device comprises a peristaltic pump.
- the first operable hydraulic constriction element of the first constriction device is configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a first portion of the luminary organ for restricting the flow of fluid therethrough.
- the second operable hydraulic constriction element of the first constriction device is a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough.
- the first operable hydraulic constriction element of the second constriction device is configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a second portion of the luminary organ for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder.
- the second operable hydraulic constriction element of the second constriction device is a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder.
- the implantable energy storage unit is connected to at least one of the first and second hydraulic pump and configured to power the first and/or second hydraulic pump after it has been started using the capacitor.
- the capacitor is a dual run capacitor.
- At least one of the first and second hydraulic pump comprises an electrical motor (M) for operating the hydraulic pump.
- M electrical motor
- the implantable pumping device further comprises an external energy storage unit configured be arranged outside of the patient’s body and configured to provide energy to the implantable energy storage unit.
- the implantable pumping device further comprises an implantable energy receiver configured to be electrically connected to the implantable energy storage unit and enable charging of the implantable energy storage unit by the external energy storage unit.
- the implantable pumping device further comprises a temperature sensor for sensing a temperature of the implantable energy storage unit.
- the implantable pumping device further comprises a temperature sensor for sensing a temperature of the capacitor
- the senor is at least one of: a hall effect sensor, a fluxgate sensor, an ultra-sensitive magnetic field sensor or a magneto-resistive sensor.
- the frequency of the magnetic field generated by the coil is less than or equal to 125kHz, preferably less than 58kHz.
- the controller comprises a receiver unit.
- the controller and the external control unit are configured to transmit and/or receive data via the receiver unit and the first coil via magnetic induction.
- the receiver unit comprises a high-sensitivity magnetic field detector.
- the receiver unit comprises a second coil.
- the implantable energy storage unit is configured to be charged via magnetic induction between the first and the second coils.
- the receiver unit is configured to control the charging of the implantable energy storage unit by controlling a receipt of electrical power from the external control unit at the receiver unit.
- the internal receiver unit is configured to control the charging of the implantable energy storage unit by controlling a transmission of electrical power from the external control unit to the receiver unit.
- the implantable pumping device further comprises a sensation generator adapted to generate a sensation detectable by a sense of the patient, the sensation generator
- RECTIFIED SHEET (RULE 91) ISA/EP being connected to the controller or the external control unit, and being configured to, upon request, generate the sensation when implanted in a patient.
- the sensation generator (381) is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator, producing a sound, providing a photonic signal, providing a light signal, providing an electric signal, a heat signal.
- the sensation generator is adapted to be implanted in the patient.
- the external control unit comprises a wireless remote control.
- the implantable pumping device further comprises an interconnecting fluid conduit fluidly connecting the first operable hydraulic constriction element to the second operable hydraulic constriction element.
- the first operable hydraulic constriction element is configured to be placed at a first portion of the urinary bladder for constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough.
- the second operable hydraulic constriction element is configured to be placed at a second portion of the luminary organ, downstream the first portion, for constricting the second portion of the urinary bladder for restricting the flow of fluid therethrough and for evacuating urine from the urinary bladder.
- the interconnecting fluid conduit is configured to conduct fluid from the first operable hydraulic constriction element to the second operable hydraulic constriction element when the pressure increases in the first operable hydraulic constriction element, such that second operable hydraulic constriction element constricts the second portion of the urinary bladder further.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising a first operable hydraulic constriction element configured to be inflated and thereby expand in a first direction towards the urinary bladder to constrict a first portion of the urinary bladder for restricting the flow of fluid therethrough.
- the implantable pumping device further comprises a supporting operable hydraulic constriction element configured to be inflated and thereby expand in the first direction towards the urinary bladder to support the first operable hydraulic constriction element in constricting the first portion of the urinary bladder for restricting the flow of fluid therethrough.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices each comprising a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a first direction to constrict a first portion of the urinary bladder for restricting the flow of fluid therethrough.
- the implantable constriction devices further comprise a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder in a second direction to constrict the first portion of the urinary bladder for restricting the flow of fluid therethrough.
- the implantable constriction devices further comprise a first hydraulic system in fluid connection with the first operable hydraulic constriction element, and a second hydraulic system in fluid connection with the second operable hydraulic constriction element.
- the first and second operable hydraulic constriction elements are adjustable independently from each other.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices.
- Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder.
- Each implantable constriction device further comprises a hydraulic reservoir for holding a hydraulic fluid.
- Each implantable constriction device further comprises a hydraulic pump for pumping fluid from the hydraulic reservoir to the operable hydraulic constriction element.
- Each implantable constriction device further comprises an electrode arrangement configured to be arranged between the implantable constriction device and the urinary bladder and to engage and electrically stimulate muscle tissue of the urinary bladder to exercise the muscle tissue to improve the conditions for long term implantation of the implantable constriction device.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices.
- Each implantable constriction device comprises a first operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder.
- Each implantable constriction device further comprises a second operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder.
- Each implantable constriction device further comprises a first hydraulic pump for pumping fluid to the operable hydraulic constriction element.
- Each implantable constriction device further comprises a second hydraulic pump for pumping fluid to the operable hydraulic constriction element.
- Each implantable constriction device further comprises a motor. The motor is mechanically connected to the first and second hydraulic pump for propelling the first and second hydraulic pump.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices.
- Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder.
- Each implantable constriction device further comprises a pressure sensor configured to sense the pressure in the operable hydraulic constriction element.
- Each implantable constriction device further comprises a hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element.
- ISA/EP implantable constriction device further comprises a controller configured to receive pressure sensor input from the pressure sensor and control the hydraulic pump on the basis of the received pressure sensor input.
- the pressure sensor comprises a diaphragm, and wherein the diaphragm is in fluid connection with the hydraulic fluid in the operable hydraulic constriction element.
- the diaphragm is further connected to a pressure sensing element of the pressure sensor, such that the pressure sensing element is separated from the hydraulic fluid in the operable hydraulic constriction element by the diaphragm
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices.
- Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder.
- Each implantable constriction device further comprises a hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element.
- the hydraulic pump comprises a compressible reservoir configured to hold a hydraulic fluid to be moved to the operable hydraulic constriction element.
- Each implantable constriction device further comprises a motor comprising a shaft. The motor is configured to generate force in a radial direction by rotation of the shaft.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an implantable pumping device comprising at least two implantable constriction devices.
- Each implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the urinary bladder.
- Each implantable constriction device further comprises a hydraulic pump for pumping a hydraulic fluid to
- the step of placing the implantable pumping device in connection with the urinary bladder comprises placing the implantable pumping device around the urinary bladder of the patient.
- the step of placing the implantable pumping device in connection with the urinary bladder comprises closing a locking or fixation device of the implantable pumping device around the urinary bladder to fixate the implantable pumping device to the urinary bladder of the patient.
- the step of inserting an implantable pumping device into the body of the patient comprises inserting an operation device comprising at least one of: an implantable hydraulic pump and an implantable valve and fixating the implantable operation device to tissue or bone in the body of the patient.
- the method further comprises the step of implanting and fixating at least one injection port in fluid connection with the operation device.
- the step of fixating the at least one injection port comprises the step of fixating the injection port subcutaneously.
- the method further comprises the step of calibrating the fluid level in the implantable pumping device.
- the method further comprises calibrating at least one of: the pressure exerted by the implantable pumping device on the urinary bladder, the time during which implantable pumping device is to remain closed after activation, the speed with which the implantable pumping device should constrict the urinary bladder, the pressure exerted on the urinary bladder relative to the blood pressure of the patient, the pressure exerted on the urinary bladder by the implantable pumping device by means of a pressure sensitive catheter, the electrical stimulation of the tissue of the urinary bladder.
- the method further comprises testing at least one of: a fully open catheter mode, a feedback function by providing sensory feedback to the patient, a post-operative mode for enabling healing, a post-operative mode for enabling growth of fibrotic tissue, electrical stimulation of the tissue of the urinary bladder.
- the step of measuring the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder further comprises comparing the measured pressure with the atmospheric pressure.
- the step of comparing the measured pressure with the atmospheric pressure comprises measuring the atmospheric pressure using a pressure sensor connected to a signal transmitter located outside the body of the patient.
- the step of increasing the pressure in the first and second implantable hydraulic constriction element to a defined level comprises inflating the first and/or second implantable hydraulic constriction element to a defined cross-sectional distance.
- the method further comprises measuring the pressure in the first and/or second implantable hydraulic constriction element when the pressure in the implantable hydraulic constriction element has been increased.
- the method further comprises the step of creating, in the controller, an absolute pressure by subtracting the pressure in the first and/or second implantable hydraulic constriction element, when substantially no pressure is exerted on the urinary bladder, from the pressure in the hydraulic constriction element, when the pressure in the implantable hydraulic constriction element has been increased.
- the step of controlling the operation device comprises controlling the operation device on the basis of the absolute pressure.
- the computing unit is further configured to compare the measured pressure with the atmospheric pressure.
- controller is configured to increase the pressure in the first and/or second implantable hydraulic constriction element on the basis of the measured pressure.
- the at least one protruding element has a diameter in the fourth plane being one of: less than a diameter of the first portion in the first plane, equal to a diameter of the first portion in the first plane, and larger than a diameter of the first portion in the first plane.
- the transmission is configured to transfer a rotating force into a linear force.
- the transmission comprises a gear system.
- the second portion comprises at least one hydraulic pump.
- the medical device further comprises a capacitor connected to at least one of the first and second energy storage unit and connected to the electrical motor.
- the capacitor is configured to: be charged by at least one of the first and second energy storage units, and provide the electrical motor with electrical power.
- At least one of the first and second portion comprises a sensation generator adapted to generate a sensation detectable by a sense of the patient.
- the second portion comprises a first hydraulic system in fluid connection with a first hydraulically operable implantable element configured to exert force on the body portion of the patient, and a second hydraulic system in fluid connection with a second hydraulically operable implantable element configured to exert force on the body portion of the patient, wherein the first and second hydraulically operable implantable elements are adjustable independently from each other.
- the 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
- the first, second and third planes are parallel to a major extension plane of the tissue.
- the fourth plane is parallel to a major extension plane of the tissue.
- the transferring member is configured to transfer hydraulic force from the second portion to the body engaging portion.
- the transferring member is configured to transfer electrical energy force from the second portion to the body engaging portion.
- the transferring member is configured to transfer data between the second portion and the body engaging portion.
- the step of placing the transferring member comprises placing the transferring member at least partially between the peritoneum and the layer of muscular tissue of the abdominal wall, such that at least 2/3 of the length of the transferring member is placed on the outside of the peritoneum of the patient.
- the step of placing the transferring member comprises placing the transferring member entirely outside of the peritoneum of the patient.
- the step of placing the transferring member comprises placing the transferring member such that it extends from the second portion to an area between the rib cage and the peritoneum of the patient, outside of the peritoneum.
- the step of placing the first portion comprises placing a first portion comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.
- the step of placing the first portion comprises placing a first portion comprising an energy storage unit.
- the step of placing the first portion comprises placing a first portion comprising a receiver for receiving at least one of: energy and communication, wirelessly.
- the step of placing the first portion comprises placing a first portion comprising a transmitter for transmitting at least one of: energy and communication, wirelessly.
- the step of placing the first portion comprises placing a first portion comprising a controller involved in the control of the powered medical device.
- the first portion is elongated and has a length axis extending substantially in the direction of the elongation of the first portion.
- the step of placing the first portion comprises placing the first portion such that the length axis is substantially parallel with the cranial- caudal axis of the patient.
- the first portion is elongated and has a length axis extending substantially in the direction of the elongation of the first portion.
- the step of placing the first portion comprises placing the first portion such that the length axis is substantially perpendicular with the cranial -caudal axis of the patient.
- the step of placing the first and second portions comprises placing the first and second portions such that the first portion length axis and the second portion length axis are placed at an angle in relation to each other exceeding 45°.
- the method of implanting powered medical device further comprises the step of placing the connecting portion through at least one layer of muscular tissue of the abdominal wall.
- the first portion, the second portion and the connecting portion are portions of a single unit.
- the method of implanting powered medical device further comprises the step of connecting the first portion to the connecting portion, in situ.
- the method of implanting powered medical device further comprises the step of connecting the second portion to the connecting portion, in situ.
- the method of implanting powered medical device further comprises the step of connecting the transferring member to the first portion.
- the method of implanting powered medical device further comprises the step of connecting the transferring member to the body engaging portion.
- the body engaging portion comprises a medical device for stretching the stomach wall such that a sensation of satiety is created.
- the body engaging portion comprises a constriction device configured to constrict a luminary organ of a patient.
- the body engaging portion comprises an implantable constriction device.
- the implantable constriction device comprises an implantable constriction device for constricting a luminary organ of the patient.
- the body engaging portion comprises an implantable element for actively emptying the urinary bladder of the patient.
- the implantable element for actively emptying the urinary bladder of the patient is configured to empty the bladder of the patient by compressing the urinary bladder from the outside thereof.
- the body engaging comprises an element for electrically stimulating a tissue portion of a patient.
- the first wireless transceiver comprises an UWB transceiver.
- the second network protocol is a standard network protocol.
- the standard network protocol may be one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
- the external device is further configured to communicate with a second external device using said at least one wireless transceiver.
- the external device is configured for determining a distance between the external device and the implantable medical device by determining the RSSI.
- a communication range of the first network protocol is less than a communication range of the second network protocol.
- a frequency band of the first network protocol differs from a frequency band of the second network protocol.
- the external device is configured to authenticate the implantable medical device if the determined distance between the external device and the implantable medical device is less than a predetermined threshold value.
- the external device is configured to allow the transfer of data between the external device and the implantable medical device after the implantable medical device has been authenticated.
- the external device is one from the list of: a wearable external device, and a handset.
- the first wireless transceiver comprises an UWB transceiver.
- the first wireless transceiver is configured for transcutaneous energy transfer for at least one of: powering an energy consuming component of the implantable medical device, and charging an implantable energy storage unit.
- the wireless communication unit comprises at least one first wireless transceiver configured for communication with the implantable medical device using a first network protocol, for determining a distance between the patient external device and the implantable medical device, and at least one second wireless transceiver configured for communication with the implantable medical device using a second network protocol, for transferring data between the patient external device and the implantable medical device.
- the patient display device further comprises an auxiliary wireless communication unit.
- the auxiliary wireless communication unit is configured to be disabled to enable at least one of: wirelessly receiving the implant control interface as the remote display portal from the patient remote external device, and wirelessly transmitting implant control user input to the patient remote external device.
- the patient display device is configured to allow the transfer of data between the patient display device and the patient remote external device on the basis of the authentication.
- the patient display device is configured to encrypt the user input.
- the computing unit is configured to encrypt the control interface and the patient display device is configured to decrypt the encrypted control interface.
- RECTIFIED SHEET (RULE 91) ISA/EP apparatus assisting the pump function of a heart of the patient, an apparatus assisting the pump function comprising a turbine bump placed within a patient’s blood vessel for assisting the pump function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing the blood flow to the coronary arteries, an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient’s body, an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable implant for stretching the stomach wall of the patient for creating satiety, an implant configured to sense the frequency of the patient ingesting food, an operable cosmetic implant, an operable cosmetic implant for adjust the shape and/or size in the breast region of a patient, an implant controlling medical device for the empty
- the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
- the patient display device further comprises an auxiliary wireless communication unit, and wherein the auxiliary wireless communication unit is configured to be disabled to enable wireless communication with the patient external device.
- the patient display device is configured to wirelessly receive an implant control interface as a remote display portal from the patient external device to be displayed on the display.
- the wireless communication unit is configured for wireless communication with the patient external device using a standard network protocol.
- the wireless communication unit is configured for wireless communication with the patient external device using a proprietary network protocol.
- the wireless communication unit is configured for wireless communication with the patient external device using a first network protocol and with the server using a second network protocol.
- the wireless communication unit is configured for wireless communication with the patient external device using a first frequency band and with the server using a second frequency band.
- the wireless communication unit comprises a Bluetooth transceiver.
- the wireless communication unit comprises a UWB transceiver.
- the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
- a communication range of the wireless communication unit is less than a communication range of the auxiliary wireless communication unit.
- the wireless communication unit comprises a first wireless transceiver for communication with the patient external device and a second wireless transceiver for communication with the server.
- the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
- the patient display device is configured to allow the transfer of data between the patient display device and the patient external device on the basis of the authentication.
- the second application is configured to receive data related to a sensor value received from the implanted medical device.
- the second application is configured to receive data related to a parameter related to at least one of: a battery status, a temperature, a time, and an error.
- the patient display device is configured to encrypt the user input.
- the display is configured to encrypt the user input for decryption by the implantable medical device.
- At least one of the first and second application is configured to receive data from an auxiliary external device and present the received data to the user.
- at least one of the first and second application is configured to receive data from an auxiliary external device comprising a scale for determining the weight of the user.
- At least one of the first and second application is configured to receive data related to the weight of the user from an auxiliary external device comprising a scale.
- the patient display device is configured to: wirelessly transmit the data related to the weight of the user to the patient external device, or wirelessly transmit an instruction derived from the data related to the weight of the user, or wirelessly transmit an instruction derived from a combination of the data related to the weight of the user and the implant control input received from the user.
- the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
- the patient remote external device and the patient EID external device are an integrated unit.
- the HCP dedicated device and the HCP EID external device are an integrated unit.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the patient display device comprises a first log-in function and a second log-in function, and wherein the first log-in function gives the user access to the first application and wherein the first and second log-in function in combination gives the user access to the second application.
- the second application is configured to receive data related to a parameter of the implanted medical device.
- the second application is configured to receive data related to a sensor value received from the implanted medical device.
- the second application is configured to receive data related to a parameter related to at least one of: a battery status, a temperature, a time, or an error.
- the patient display device is configured to encrypt the user input.
- the display is configured to encrypt the user input for decryption by the implantable medical device.
- the patient remote external device is configured to act as a router, transferring the encrypted user input from the patient display device to the implantable medical device without decryption.
- the patient remote external device is configured to encrypt at least one of the control interface and the control commands.
- the patient remote external device is configured to encrypt the control interface and wherein the patient display device is configured to decrypt the encrypted control interface.
- the second application is configured to receive data related to a sensor value received from the implanted medical device.
- the second application is configured to receive data related to a parameter related to at least one of: a battery status, a temperature, a time, or an error.
- the implantable medical device comprises at least one of: an external heart compression device, an apparatus assisting the pump function of a heart of the patient, an apparatus assisting the pump function comprising a turbine bump placed within a patient’s blood vessel for assisting the pump function of the heart, an operable artificial heart valve, an operable artificial heart valve for increasing the blood flow to the coronary arteries, an implantable drug delivery device, an implantable drug delivery device for injecting directly into a blood vessel and change the position of the injection site, all from within the patient’s body, an implantable drug delivery device for injecting potency enhancing drugs into an erectile tissue of the patient, a hydraulic, mechanic, and/or electric constriction implant, an operable volume filling device, an operable gastric band, an operable
- RECTIFIED SHEET (RULE 91) ISA/EP of an erectile tissue, an implant with a reservoir for holding bodily fluids, an implant storing and/or emptying a bodily reservoir or a surgically created reservoir, an implant communicating with a database outside the body, an implant able to be programmed from outside the body, an implant able to be programmed from outside the body with a wireless signal, an implant treating impotence, an implant controlling the flow of eggs in the uterine tube, an implant controlling the flow of sperms in the uterine tube, an implant controlling the flow of sperms in the vas deferens, an implant for hindering the transportation of the sperm in the vas deferens, an implant treating osteoarthritis, an implant performing a test of parameters inside the body, an implant controlling specific treatment parameters from inside the body, an implant controlling bodily parameters from inside the body, an implant controlling the blood pressure, an implant controlling the blood pressure by affecting the dilatation of the renal artery, an implant controlling a drug
- the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
- the patient remote external device and the patient EID external device are an integrated unit.
- the HCP dedicated device and the HCP EID external device are an integrated unit.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is
- the patient display device is configured to wirelessly receive an implant control interface from the patient external device to be displayed on the display.
- at least two of: the wireless communication unit of the server, the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device are configured for wireless communication using a standard network protocol.
- the wireless communication unit of the server the wireless communication unit of the patient display device, the wireless communication unit of the patient external device, and the wireless communication unit of the implantable medical device, are configured for wireless communication using a proprietary network protocol.
- the wireless communication unit of the patient external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the server, or use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the patient display device.
- the wireless communication unit of the patient external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the server, or use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient display device.
- the wireless communication unit of the patient display device is configured to use a first network protocol for communication with the patient external device and use a second network protocol for communication with the server.
- the wireless communication unit of the patient display device is configured to use a first frequency band for communication with the patient external device and use a second frequency band for communication with the server.
- the wireless communication unit of the server is configured to use a first network protocol for communication with the patient external device and use a second network protocol for communication with the patient display device.
- the wireless communication unit of the server is configured to use a first frequency band for communication with the patient external device and use a second frequency band for communication with the patient display device.
- the wireless communication unit of at least one of the server, the patient display device, the patient external device, and the implantable medical device comprises a UWB transceiver.
- the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
- the wireless communication unit of the patient external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the server, and wherein the second wireless transceiver has a longer effective range than the first wireless transceiver.
- the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
- RECTIFIED SHEET (RULE 91) ISA/EP less than a predetermined threshold value
- the patient external device is configured to be authenticated by the implantable medical device if a distance between the patient external device and the implantable medical device is less than a predetermined threshold value.
- the patient external device is configured to allow the transfer of data between the patient display device and the patient external device on the basis of the authentication.
- the patient display device is a wearable patient external device or a handset.
- the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- HCP private key device comprises a hardware key.
- the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the DDI.
- the patient EID external device comprises a first wireless transceiver for wireless communication with the implantable medical device, and a second wireless transceiver for wireless communication with the DDI, and wherein the second wireless transceiver has longer effective range than the first wireless transceiver.
- the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
- the patient EID external device is a wearable patient external device or a handset.
- the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
- the system further comprises the patient display device, which may comprise a supporting application, a display which hosts the Remote Display Portal, and a patient display device private key.
- the patient display device which may comprise a supporting application, a display which hosts the Remote Display Portal, and a patient display device private key.
- the remote display portal is capable of generating a command to be signed by the patient display device private key.
- the patient remote external device is adapted to accept input from the patient via said patient display device through its remote display portal.
- the patient remote external device comprises a graphical user interface arranged on a touch-responsive display exposing buttons to express actuation functions of the implanted medical device.
- the system is configured to allow the patient to actuate the implant at home through the patient remote external device by means of an authorization granted by a patient private key.
- the patient private key comprises at least one of: a smart card, a keyring device, a watch, a arm or wrist band, a necklace, and any shaped device.
- the system is configured to allow the patient to actuate the implantable medical device, when implanted, at home through the patient remote external device, using an authorization granted by the patient private key.
- system further comprises a patient EID external device comprising at least one of: a reading slot or comparable for the patient private key device, a RFID communication, and a close distance wireless activation communication, or electrical direct contact.
- patient EID external device is adapted to be synchronised with the patient remote external device.
- the patient EID external device further comprises at least one of: a wireless transceiver configured for communication with the patient, a remote external device, and a wired connector for communication with the patient remote external device.
- the patient EID external device is adapted to generate an authorization to be signed by the patient private key to be installed into at least one of: the patient remote external device through the patient EID external device, and the implantable medical device.
- the system comprises a patient display device comprising a supporting application capable of displaying the remote display portal with content delivered from the patient remote external device.
- the remote display portal and patient remote external device are adapted to expose buttons to express the will to actuate the functions of the implanted medical device by the patient through the patient remote external device.
- the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
- the patient remote external device and the patient EID external device are an integrated unit.
- the HCP dedicated device and the HCP EID external device are an integrated unit.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the at least one patient EID external device is adapted to receive information from the implant, through a second network protocol.
- the system comprises the DDI, wherein the DDI is adapted to receive information from said patient EID external device, and wherein the DDI comprises a wireless transceiver configured for communication with said patient EID external device.
- the patient private key device is adapted to provide the patient private key to the patient EID external device by the patient via at least one of; a reading slot or comparable for the patient private key device, an RFID communication or other close distance wireless activation communication, or electrical direct contact.
- the patient EID external device comprises at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and other close distance wireless activation communication, or direct electrical contact.
- the patient EID external device further comprising at least one wireless transceiver configured for communication with the implanted medical device through a second network protocol.
- the system comprises the implantable medical device, which may be adapted to, when implanted, treat the patient or perform a bodily function.
- the patient private key comprises at least one of: a smart card, a keyring device, a watch, an arm band or wrist band, a necklace, and any shaped device.
- at least two of: the patient EID external device, the IDD, and the patient private key device are configured for wireless communication using a standard network protocol.
- At least two of: the patient EID external device, the IDD, and the patient private key device, are configured for wireless communication using a proprietary network protocol.
- the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient private key device.
- At least one of the patient EID external device, the patient private key device and the IDD comprises a UWB transceiver.
- the standard network protocol is one from the list of: Radio Frequency type protocol, RFID type protocol, WLAN type protocol, Bluetooth type protocol, BLE type protocol, NFC type protocol, 3G/4G/5G type protocol, and GSM type protocol.
- the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
- the second wireless transceiver is configured to be disabled to enable wireless communication using the first wireless transceiver.
- the system comprises a master private key device configured to allow issuance of a new private key device, wherein the HCP or HCP admin have such master private key device adapted to able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
- the patient remote external device and the patient EID external device are an integrated unit.
- the HCP dedicated device and the HCP EID external device are an integrated unit.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the at least one patient remote external device comprises a patient remote external device private key, wherein the DDI via the patient EID external device is able to inactivate the authority and authenticating function of the patient remote external device, thereby inactivating the patient remote external device.
- the patient EID external device comprises at least one wireless transceiver configured for communication with the DDI via a first network protocol.
- the system comprises the DDI, wherein the DDI is adapted to receive command from a HCP EID external device, and to send the received command to the patient EID external device, wherein the DDI comprises a wireless transceiver configured for communication with said patient external device.
- the patient EID external device is adapted to receive the command from the DDI, wherein the command originates from a health care provider, HCP, wherein the patient EID external device is adapted to receive the command from the HCP via the DDI to inactivate the patient remote external device comprising a patient remote external device private key, and wherein the patient EID external device is further adapted to send this command to the implanted medical device.
- HCP health care provider
- the patient EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the patient private key device.
- the patient EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the patient private key device.
- At least one of the patient remote external device, the patient EID external device, the patient private key device, and the DDI comprise a Bluetooth transceiver.
- the second wireless transceiver has an effective range being one of: 2 times, 4 times, 8 time, 20 times, 50 times or 100 times longer than the effective range of the first wireless transceiver.
- the patient EID external device is a wearable patient external device or a handset.
- the data encrypted by the implantable medical device is related to at least one of: a battery status, a temperature, a time, or an error.
- the patient remote external device and the patient EID external device are an integrated unit.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the system comprises a master private key device that allow issuance of new private key device wherein the HCP or HCP admin have such master private key device adapted to be able to replace and pair a new patient private key device or HCP private key device into the system, through the HCP EID external device.
- the patient remote external device and the patient EID external device are an integrated unit.
- the system further comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system further comprises a food sensor adapted to measure at least if the patient swallows solid food or is drinking fluid, wherein said food sensor is configured to be connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the HCP EID external device further comprises a wireless transceiver configured for communication with the implanted medical device through a second network protocol.
- the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
- the HCP EID external device is adapted to receive a command from an HCP dedicated device to change said pre-programmed treatment steps of the implantable medical device, when implanted, wherein the HCP dedicated device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing their private key.
- At least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.
- the patient private key device comprises a patient private key, comprising at least one of: a smart card, a keyring device, a watch, an arm or wrist band, a necklace, and any shaped device.
- the patient private key is adapted to activate, be authenticated, and allowed to perform said command provided by the HCP, either via the HCP EID external device or when the action is performed remotely via a patient EID external device.
- the system comprises a master private key device that allows issuance of new private key device wherein the HCP or HCP admin have such master private key device adapted to be able to replace and pair a new patient private key device or HCP private key device into the system.
- the patient remote external device and the patient EID external device are an integrated unit.
- the system further comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and patient display device.
- RECTIFIED SHEET (RULE 91) ISA/EP the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the HCP EID external device further comprises a wireless transceiver configured for communication with the implanted medical device through a second network protocol.
- the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of: a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
- the HCP EID external device comprises at least one of: reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
- the HCP EID external device is adapted to receive a command from an HCP dedicated device to change said pre-programmed treatment steps of the implantable medical device, when implanted, wherein the HCP dedicated device is further adapted to be activated, authenticated, and allowed to perform said command by the HCP providing their private key.
- the HCP EID external device and the HCP private key device are configured for wireless communication using a standard network protocol.
- the HCP EID external device and the HCP private key device are configured for wireless communication using a proprietary network protocol.
- the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the HCP private key device.
- the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the HCP private key device.
- At least one of the HCP EID external device and the HCP private key device comprises a Bluetooth transceiver.
- At least one of the patient private key device or HCP private key device comprises a hardware key.
- the private key device is at least one of, a smartcard, a key-ring device, a watch an arm or wrist band a neckless or any shaped device.
- the HCP dedicated device and the HCP EID external device are an integrated unit.
- the system comprises a measurement device or sensor adapted to deliver a measurement to at least one of the DDI, patent EID external device and a patient display device.
- the system comprises a food sensor, adapted to measure at least if the patient swallow solid food or is drinking fluid, wherein said food sensor is connected to the control unit of a medical device to cause an action to stretch the stomach after a determined amount of food intake.
- the HCP private key device is adapted to be provided to the at least one HCP external device via at least one of; a reading slot or comparable for the HCP private key device, a RFID communication, and a close distance wireless activation communication unit, or electrical direct contact.
- the HCP EID external device is configured to use a first network protocol for communication with the implantable medical device and use a second network protocol for communication with the HCP private key device.
- the HPC EID external device is configured to use a first frequency band for communication with the implantable medical device and use a second frequency band for communication with the HCP private key device.
- At least one of the HCP EID external device and the HCP private key device comprises a UWB transceiver.
- FIG. 2 shows an embodiment of an implantable pumping device for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- Fig. 4a-4c shows an embodiment of an implantable pumping device for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- FIG. 7 shows an embodiment of an implantable pumping device for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- FIG. 8 shows an embodiment of an implantable pumping device for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- FIG. 9 shows an embodiment of an implantable pumping device comprising hydraulic constriction devices for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- Fig. 14 shows an embodiment of an implantable pumping device using electric stimulation for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- Fig. 15b shows an embodiment of an implantable constriction device for constricting the luminary organ of a patient, in an elevated view when placed around the luminary organ.
- Fig. 15c shows an embodiment of an implantable constriction device for constricting the luminary organ of a patient, in an elevated view when placed around the luminary organ, in the state when the implantable constriction device constricts the luminary organ.
- Fig. 15d shows an embodiment of an implantable constriction device for constricting the luminary organ of a patient, in an elevated view when placed around the luminary organ, in the state when the implantable constriction device constricts the luminary organ.
- Fig. 15f shows an embodiment of an implantable pumping device for constricting the urinary bladder of a patient, in an elevated view when placed around the urinary bladder.
- Fig. 24a shows an embodiment of an implantable constriction device for constricting the luminary organ of a patient in a sectional view, in its constricted state.
- Fig. 49g shows a partially sectional perspective view from the left of an embodiment of a hydraulic pump for an implantable constriction device.
- Fig. 6 la-6 lb shows an embodiment of an implantable pumping device being a rotary peristaltic pump for constricting a urinary bladder of a patient and for evacuating urine from the urinary bladder.
- Figs. 62a - 62c are flow charts describing various aspect of the surgical procedure required for implanting and testing the implantable constriction device.
- Inflatable is to be understood as possible to fill with a fluid, which may be a liquid, or gaseous fluid, or a plurality of solid structures suspended in a fluid, for the purpose of expanding the inner volume of a luminary device.
- a fluid which may be a liquid, or gaseous fluid, or a plurality of solid structures suspended in a fluid, for the purpose of expanding the inner volume of a luminary device.
- the support element 24 is substantially rigid and has a modulus of elasticity (E), radially, in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa.
- E modulus of elasticity
- the modulus of elasticity calculated as the elastic deformation of an area of the inner surface of the support element 24 causing an elongation in the radius at that area, when a force is applied to that area from the center of the support element 24.
- the surrounding structure 20 has a major portion, i.e. a portion making up more than half of the periphery P of the surrounding structure
- the first and second constriction device 10a, 10b both comprise a first and a second constriction element 101a’, 101a”, 101b’, 101b”, wherein the first constriction element 101a’, 101b’ is configured to contact a first portion of the urinary bladder and the second constriction element 101a”, 101b” is configured to contact a second portion of the urinary bladder, such that the urinary bladder is constricted between the first and second constriction elements.
- each constriction device may comprise more than two constriction elements.
- the first and third constriction elements 101a’, 101b’ are configured to exert pressure on the urinary bladder U in a first direction to constrict the urinary bladder.
- the second and fourth constriction elements 101a”, 101b” are configured to exert pressure on the urinary bladder U in a second direction to constrict the urinary bladder.
- the second distance is substantially opposite to the first direction.
- a major portion of the support element 24 is made from a rigid material, and a major portion of the operable constriction elements 101a’, 101a”, 101b’, 101b” are made from a resilient material, and the resilient material is more than 2 times as elastic as the rigid material.
- the embodiments shown in figs. 3a-3c may also comprise a controller configured to control the first and second constriction device in order to evacuate urine from the urinary bladder U of a patient.
- the radius of the curvature C is anywhere in the range 15mm - 60mm.
- the support element 24 is substantially rigid and has a modulus of elasticity (E), radially, in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa. I.e. the modulus of elasticity calculated as the elastic deformation of an area of the inner surface of the support element 24 causing an elongation in the radius at that area, when a force is applied to that area from the center of the support element 24.
- the surrounding structure 20 has a major portion, i.e.
- Fig. 4b shows the implantable pumping device 10 according to the embodiment described with reference to fig. 4a in a state in which the first and second operable constriction
- Fig. 4c shows the implantable pumping device 10 according to the embodiment described with reference to figs. 4a and 4b in a state in which the third, fourth, fifth, sixth, seventh and eighth operable constriction elements 101b’, 101b”, 101c’, 101c”, 10 Id’, 10 Id” are at least partially constricting the urinary bladder U.
- the third and fourth operable constriction elements 101b’, 101b” may be configured to constrict the second portion P2 after the first and second operable constriction elements 101a’, 101a” constricts the first portion Pl but before the fifth and sixth operable constriction elements 101c’, 101c” constricts the third portion P3.
- the seventh and eighth operable constriction elements 10 Id’ , 10 Id” may be configured to constrict the fourth portion P4 of the urinary bladder U after the fifth and sixth operable constriction elements 101c’, 101c” have constricted the third portion P3 of the urinary bladder U. Allowing the implantable pumping device 10 to sequentially constrict the urinary bladder U may ensure that no urine is trapped in any of the portions P1,P2,P3,P4 and thusly ensure a smooth and safe pumping of the urine out of the urinary bladder U.
- Fig. 5 shows an implantable pumping device 10 according to one embodiment when placed surrounding a first Pl and second portion P2 of the urinary bladder U.
- the embodiment in fig. 5 resembles the embodiment in fig. 3a and may comprise any feature that is brought up with reference to fig. 3a.
- the implantable pumping device 10 is in a partially relaxed state and the urinary bladder U is substantially un-constricted.
- the implantable pumping device is comprised of a support element 24, being a surrounding structure 20 surrounding the urinary bladder U.
- the implantable pumping device 10 comprises a first constriction device configured to constrict the first portion P 1 of the urinary bladder U for closing the first portion P 1 of the urinary bladder U.
- the embodiment shown in fig. 5 may comprise a urethra contacting element in the form of a cushioning element 30 which is more resilient than the support element 24b and thereby provides a less damaging contacting surface against the urethra U, such that damage to the urethra U is minimized.
- Fig. 6 shows an implantable pumping device 10 according to one embodiment when placed surrounding a first Pl, a second P2, a third P3 and a fourth portion P4 of the urinary bladder U.
- the embodiment shown in fig. 6 resembles the embodiment of fig. 5.
- the second constriction device comprises a plurality of operable constriction elements 10 lb, 101c, 10 Id configured to sequentially constrict the urinary bladder for evacuating urine from the urinary bladder.
- the first operable constriction element 101a is configured to constrict the first portion Pl of the urinary bladder U together with at least one abutment configured to contact at least a portion of the first portion P 1 and for withholding the force from the first operable constriction element 101a.
- the second, third and fourth operable constriction element 101b, 101c, 10 Id are configured to constrict the urinary bladder U together with at least one abutment configured to contact at least a portion of the urinary bladder U and for withholding the force from the second, third and fourth operable constriction elements 101b, 101c, 10 Id for evacuating urine from the urinary bladder.
- the operable constriction elements 10 la, 10 lb, 101c, 10 Id may be configured to constrict the urinary bladder U in sequence so that no urine is trapped between the operable constriction elements 101a, 101b, 101c, 10 Id.
- Fig. 7 shows an implantable pumping device 10 according to one embodiment when placed surrounding a first and a second portion Pl, P2 of the urinary bladder U.
- the embodiment shown in fig.7 resembles the embodiment of fig. 3a-3c and may comprise any features presented in relation to these features.
- the first, second, third and fourth operable constriction elements 101 a’, 101 a”, 101b’, 101b” of the first and second constriction device are constricting the first and second portion Pl, P2 of the urinary bladder U.
- the first constriction device comprises a first curvature Cl having a first radius R1 adapted for a curvature of the urinary bladder U.
- the second constriction device comprises a second curvature C2 having a second radius R2 adapted for a curvature of the urinary bladder U.
- the first radius R1 is smaller than the second radius R2. This may be beneficial since the implantable pumping device 10 is tilted an angle a.
- the urinary bladder U may not be straight but may instead have a tapered shape, an implantable pumping device 10 comprising a tapered shape may then provide a snugger fit.
- the first and second constriction device may then be closer to the wall of the urinary bladder U and may therefore not have to be moved an unnecessary distance in order to constrict the urinary bladder U in order to evacuate urine.
- the embodiment of fig. 8 may have a tapered shape and the implantable pumping device 10 may be tilted an angle a.
- the first, second, third and fourth fluid conduits 109a’, 109a”, 109b ’,109b” may be configured such that a fluid can flow through the at least partially integrated fluid conduit 109a’, 109a”, 109b ’,109b” into the operable hydraulic constriction elements 101a’, 101a”, 101b’, 101b” for constricting the urinary bladder U.
- Fig. 10 shows an implantable pumping device 10 according to an embodiment and similar to the embodiment in fig. 9.
- the first and second constriction devices are hydraulic constriction devices.
- the first and second constriction devices comprises operable hydraulic constriction elements 101a’, 101a”, 101b’, 101b”, 101c’, 101c”, 10 Id’, 10 Id” for constricting the urinary bladder U.
- the second constriction device comprises a plurality of operable hydraulic constriction elements 101b’, 101b”, 101c’, 101c”, 101d’, lOld” to sequentially constrict the urinary bladder for evacuating urine from the urinary bladder U.
- the first, second, third and fourth fluid conduits 109a’, 109a”, 109b’, 109b”, 109c’, 109c”, 109d’, 109d” may be configured such that a fluid can flow through the at least partially integrated fluid conduit 109a’, 109a”, 109b’, 109b”, 109c’, 109c”, 109d’, 109d” into the operable hydraulic constriction elements 101a’, 101a”, 101b’, 101b”, 101c’, 101c”, 101d’, lOld” for constricting the urinary bladder U.
- a second mechanical constriction device 10b is located configured to constrict a second portion of the urinary bladder U and to evacuate urine from the urinary bladder U. Similar to the first mechanical constriction device 10a, the second mechanical constriction device 10b comprises two operable mechanical constriction elements 101b’, 101b”. The two operable mechanical constriction elements 101b’, 101b” each comprises an electrical motor Mb’, Mb”, a screw 701b’, 701b” and a plate 702b’, 702b”. The second constriction device 10b is configured to constrict the urinary bladder U after the first constriction device 10a has constricted the urinary bladder U.
- the second mechanical constriction device 10b may be larger than the first mechanical constriction device 10a. It is also conceivable that at least one of the first and the second mechanical constriction devices 10a, 10b comprises more or fewer mechanical constriction elements than discloses in fig. 11. As an example, fig. 12 is provided.
- the mechanical constriction elements 101a’, 101a”, 101b’, 101b”, 101c’, 101c”, 101c”, 101d’, lOld” ofboth the first and second mechanical constriction device 10a, 10b each comprise an electrical motor Ma’, Ma”, Mb’, Mb”, Me’, Me”, Md, Md”, a screw 701a’, 701a”, 701b’, 701b”, 701c’, 701c”,701d’,701d” and a plate 702a’, 702a”, 702b’, 702b”, 702c’, 702c”, 702d’, 702d”.
- the plate 702 is configured to be moved the screw 701 in order to constrict the urinary bladder U. In this way the implantable pumping device can move the urine from the urinary bladder U and forward through the urethra.
- Fig. 13 shows an implantable pumping device 10 according to an embodiment of the present invention.
- the implantable pumping device 10 is a rotary peristaltic pump 10 that is applied to the urinary bladder U of a patient.
- the rotary peristaltic pump 10 includes a rotor 200 carrying a constriction device 10a in the form of three cylindrical constriction elements 101a, 101b and 101c positioned equidistantly from the axis 23 of the rotor 200.
- the constriction elements 101 a- 101c may be designed as rollers.
- a stationary elongate support element 24 is positioned spaced from but close to the rotor 200 and has a part cylindrical surface 25 concentric with the axis 23 of the rotor 200.
- the pump 10 is applied on the urinary bladder U, so that the urinary bladder U extends between the support element 24 and the rotor 200.
- the implantable pumping device 10 may also comprise a control device that controls the rotor 200 to rotate so that the constriction elements 101 a- 101c successively constricts portions of a series of selected portions of the urinary bladder U against the elongate support element 24.
- the constriction element 22A constricts the urinary bladder U at a first portion P 1.
- the third constriction element 101c will engage the urinary bladder U and force urine from the bladder to be pushed down and to be evacuated.
- a control device can therefore control the rotor 20 to cyclically move the constriction elements 101 a- 101c one after the other
- RECTIFIED SHEET (RULE 91) ISA/EP along the elongate support element 24 while constricting the selected portions of urinary bladder U, so that urine in the urinary bladder U is displaced in a peristaltic manner.
- the same constriction principle may also be practiced by other mechanical constriction devices that do not include a rotor. Further features of an implantable pumping device 10 of the sort disclosed with regards to Fig. 13 can be found in relation to Figs. 61a and 61b.
- Fig. 14 shows an implantable pumping device 10 according to an embodiment of the present invention.
- the implantable pumping device 10 is configured to constrict and evacuate urine from the urinary bladder U but here the first constriction device 10a and the second constriction device 10b are constriction devices configured to constrict by electrically stimulating at least one tissue wall of the urinary bladder U.
- the first constriction device 10a may be configured to stimulate a first portion of the urinary bladder U in order to constrict the urinary bladder U so that urine cannot pass.
- the second constriction device 10b may be configured to stimulate a second portion of the urinary bladder U after the first constriction device has stimulated the first portion of the urinary bladder in order to constrict the urinary bladder U and thusly force the urine to be evacuated from the urinary bladder U.
- Further features of an implantable pump of this sort can be found in relation to other figures, for example figure 59.
- the implantable pumping device 10 of Fig. 14 may also comprise a cancellation unit configured to be placed downstream the second portion.
- the cancellation unit may be configured to cancel the electrical stimulation such that the urinary sphincter remains substantially unaffected by the electrical stimulation.
- the electrodes or electrode arrangement of the constriction devices 10a, 10b in Fig. 14 may also be configured to engage and electrically stimulate the muscle tissue of the urinary bladder U to exercise the muscle tissue to improve the conditions for long term implantation of the implantable pumping device 10.
- Such an electrode arrangements may also be present in any one of the embodiments described in relation to Figs. 1-13.
- ISA/EP second constriction device 10b are also plausible. However, it is advantageous that the second portion P2 being constricted by the second constriction device 10b is larger than the first portion Pl in order to evacuate more urine from the urinary bladder.
- the second portion P2 may also be constricted by many constriction elements as described for example in relation to figure 4,6,8,10, 12.
- Fig. 15a shows an embodiment of a first constriction device 10a configured to constrict a portion of the urinary bladder U for closing a first portion of the urinary bladder U of a patient.
- the first constriction device 10a may be part of an implantable pumping device, for example as disclosed in relation to fig. 3a-3c or 9, and comprises a surrounding structure having a periphery surrounding the urinary bladder U when implanted.
- the surrounding structure comprises two support elements 24a, 24b connected to each other for forming the surrounding structure.
- the first support element 24a is configured to support a first operable hydraulic constriction element 101a’ and a third operable hydraulic constriction element 101a’”.
- the second support element 24b is configured to support a second operable hydraulic constriction element 101a” and a fourth operable hydraulic constriction element 101a””.
- the fourth integrated channel 23d is also drilled, milled or casted into the material of the second support element 24b.
- the fixation surface also comprises an outlet from the fourth integrated channel 23d into the fourth operable hydraulic constriction element 101a””, such that fluid can be transferred from the fourth tubing to the fourth integrated channel 23d and into the fourth operable hydraulic constriction element 101a”” for expanding the fourth operable hydraulic constriction element 101a””.
- the tubing portion of the fluid conduits 109a’, 109a”, 109a’”, 109a”” is preferably made from a biocompatible material such as silicone and/or polyurethane.
- Integrating the fluid conduit(s) in the support element(s) enables the fluid entry to the operable hydraulic constriction elements 101a’, 101a”, 101a’”, 101a”” to be protected and encapsulated by the support element(s) which reduces the space occupied by the operable hydraulic constriction element 10 and reduces the amount of protruding portions thus reducing the risk of damaging the urinary bladder U.
- the first constriction device 10a shown in fig. 15a may correspond to part of an implantable pumping device 10 for evacuating urine from the urinary bladder as disclosed throughout this application.
- the implantable pumping device may also include a second constriction device similar to the one disclosed in fig. 15a-15e.
- the second constriction device may be arranged downstream the first portion, i.e. downstream the first constriction device 10a, and be configured for evacuating urine from the urinary bladder when the first portion of the urinary bladder is closed.
- a second constriction device similar to the first constriction device 10a may be incorporated into the same support structure 24 or an individual support structure placed adjacent the support structure 24 shown in fig. 15a-15e.
- the shared first and second hydraulic systems may be separate from each other and thus without fluid communication.
- the advantage of having the first and second operable hydraulic constriction element 101a’, 101a” connected to separate hydraulic systems is that the first and second operable hydraulic constriction element 101a’, 101a” may be filled the same amount of hydraulic fluid irrespective of the amount of resistance from the urinary bladder U that the respective first and second operable hydraulic constriction element 101a’, 101a” encounters. This means that the urinary bladder U will always be centered in the first construction device, and thus in the implantable pumping device 10, which reduced the risk of tissue damage to the urinary bladder U.
- the first, second, third and fourth operable hydraulic constriction element 101a’, 101a”, 101a’”, 101a”” may be connected to a shared hydraulic system, such that the hydraulic fluid can be
- RECTIFIED SHEET (RULE 91) ISA/EP pumped from the first and second operable hydraulic constriction element 101a’, 101a” to the third and fourth operable hydraulic constriction element 101a’”, 101a”” for releasing the constriction of the urinary bladder U for restoring the flow of fluid therethrough, and pumped from the third and fourth operable hydraulic constriction element 101a’”, 101a”” to the first and second operable hydraulic constriction element 101a’, 101a” for constricting the urinary bladder U and restricting the flow of fluid therethrough.
- An implantable pumping device may include a first constriction device 10a according to the embodiment shown in fig. 15a-15e.
- the implantable pumping device may further comprise a second constriction device according to the embodiment shown in fig. 15a-15e placed adjacent the first constriction device 10a.
- the first constriction device 10a may be configured to constrict a first portion of the urinary bladder U extending a first distance axially in the direction of the flow of urine.
- the second constriction device may be configured to constrict a second portion of the urinary bladder U extending a second distance axially in the direction of the flow of urine.
- the second distance may be at least two times as long as the first distance.
- the first constriction device 10a may constrict the urinary bladder U in order to restrict the flow of urine.
- the second constriction device may then be used in order to constrict the second portion of the urinary bladder U for evacuating urine from the urinary bladder U.
- the surrounding structure 20 When closed, the surrounding structure 20 is substantially rigid and has a modulus of elasticity (E), radially, in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa. I.e. the modulus of elasticity calculated as the elastic deformation of an area of the inner surface 22 of the surrounding structure 20 causing an elongation in the radius R at that area when a force is applied to that area from the center of the surrounding structure 20.
- E modulus of elasticity
- Fig. 15d shows an embodiment of the first constriction device 10a when in its constricted state.
- the embodiment shown in fig. 15d is identical to the embodiment shown in figs 15a - 15c, the only difference being that the tubing fixation portions 25a, 25b enters the first and second support elements 24a, 24b perpendicularly into the first and second support elements 24a, 24b such that the fluid conduits 109a’, 109a”, 109a” ’,109a””” enters the support elements 24a, 24b perpendicularly, after which the fluid conduits is transferred over to the integrated channels in the support elements 24a, 24b.
- Fig. 15d shows an embodiment of the first constriction device 10a when in its constricted state.
- the embodiment shown in fig. 15d is identical to the embodiment shown in figs 15a - 15c, the only difference being that the tubing fixation portions 25a, 25b enters the first and second support elements 24a, 24b perpendicularly
- the length 12 of the first and second operable hydraulic constriction elements 101a’, 101a” is longer than the length of the support elements 24a, 24b and thereby than the length of the surrounding structure 20.
- the first and second operable hydraulic constriction elements 101a’, 101a” are 1.2 times as long as the surrounding structure 20 but in alternative embodiments, the constriction elements may be as little as 1.1 times as long as the surrounding structure 20 or as much as 1.5 or 2 times as long as the surrounding structure 20.
- the constriction elements may also be shorter than the surrounding structure.
- the surrounding structure is to house more than the constriction elements disclosed in figures 15a-15e.
- the constriction elements may be arranged as in fig.
- a major portion of the surrounding structure 20 is made from a rigid material, and a major portion of the first and second operable hydraulic constriction elements 101a’, 101a” are made from a resilient material, and the resilient material is more than 2 times as elastic as the rigid material.
- Fig. 15f shows a similar structure as the one shown in fig. 15a.
- an implantable pumping device 10 for evacuating urine from the urinary bladder U of a patient is shown.
- the implantable pumping device 10 has the same structure as the first constriction device 10a shown in fig. 15a expect here the surrounding structure 20 also houses a second constriction device configured to
- the second support 24b element has a curvature C having the same radius R1 as a curvature C of the first support element 24a.
- the third support element 24c is adapted for a larger urinary bladder and has a more U-shaped cross section perpendicular to the axial direction of the urinary bladder U and thus has a curvature C having a smaller radius R3.
- the fourth support element 24d is adapted for a smaller urinary bladder and has a shallower cross-section perpendicular to the axial direction of the urinary bladder U and thus has a curvature C having a larger radius R3 than the radii R1 and R2.
- the first support element 24a comprises a first operable hydraulic constriction element 101a’ configured to be inflated with a hydraulic fluid entering the first operable hydraulic constriction element 101a’ through a first hydraulic fluid conduit 109a’ via a tubing fixation portion 25a for constricting a portion of the tissue wall of the urinary bladder and thereby restrict the flow of fluid therethrough.
- the second, third and fourth support elements 24b, 24c, 24d all comprise a second operable hydraulic constriction element 101a” configured to be inflated with a hydraulic fluid entering the second operable hydraulic constriction element 101a” through a second hydraulic fluid conduit 109b via a tubing fixation portion 25b for constricting a portion of the tissue wall of the urinary bladder and thereby restrict the flow of fluid therethrough.
- Fig. 16e shows an alternative embodiment of the supporting element 24d.
- the supporting element of fig. 16e has an identical curvature but is in turn divided into a second and third support elements 24b, 24c such that the surrounding structure will be comprised of three support elements 24a (of fig. 16a), 24b, 24c together having a periphery encircling the urinary bladder.
- the second and third support elements 24b, 24c each comprises connecting portions 24b’, 24b”, 24c’, 24c” such that a first connecting portion 24b’ of the second support element 24b can be connected to the first support element and a second connecting portion 24b” of the second support element 24b can be connected to the first connecting portion 24c’ of the third support element 24c and a second connecting portion 24c” of the third support element 24c can be connected to the first support element.
- the second and third support elements 24b, 24c each comprises cushioning elements 30a, 30b configured to contact the urinary bladder.
- the cushioning elements 30a, 30b are fixated to the inner surface of the support elements 24b, 24c by means of an adhesive and is more resilient than the support elements 24b, 24c.
- the cushioning elements 30a, 30b are made from a solid medical grade silicone or polyurethane material.
- a major portion of the all the support elements of the embodiments of figs. 3a - 16f can be made of a substantially rigid material, such that the resulting surrounding structure becomes substantially rigid.
- the material of the major portion may comprise a material having a modulus of elasticity (E), in the range 0,2 GPa - 1000 GPa or in the range 1 GPa - 400 GPa.
- the material could for example be a biocompatible metallic material, such as titanium or a medical grade metal alloy, such as medical grade stainless steel.
- material could be a ceramic material such as zirconium carbide, or a stiff medical grade polymer material such as Ultra-high-molecular-weight polyethylene (UHMWPE) or Polytetrafluoroethylene (PTFE) or a thermoplastic polyester such as polylactide (PLA).
- the support elements could also comprise at least one composite material, such as any combination of metallic/ceramic and polymer materials or a polymer material reinforced with organic or inorganic fibers, such as carbon or mineral fibers.
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- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2021/073893 WO2022043555A1 (en) | 2020-08-31 | 2021-08-30 | Providing remotely energy for an implant comprising a capacitor for providing necessary energy bursts for the energy consuming parts of the implant |
| SE2250217 | 2022-02-18 | ||
| SE2250204 | 2022-02-18 | ||
| PCT/EP2022/073763 WO2023031032A1 (en) | 2021-08-30 | 2022-08-26 | Apparatus and method for obtaining urinary control |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4395704A1 true EP4395704A1 (de) | 2024-07-10 |
Family
ID=90052910
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP22772432.5A Pending EP4395704A1 (de) | 2021-08-30 | 2022-08-26 | Vorrichtung und verfahren zur urinkontrolle |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4395704A1 (de) |
| AU (1) | AU2022336957A1 (de) |
| CA (1) | CA3230660A1 (de) |
-
2022
- 2022-08-26 EP EP22772432.5A patent/EP4395704A1/de active Pending
- 2022-08-26 AU AU2022336957A patent/AU2022336957A1/en active Pending
- 2022-08-26 CA CA3230660A patent/CA3230660A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| AU2022336957A1 (en) | 2024-04-11 |
| CA3230660A1 (en) | 2023-03-09 |
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