Implantable devices for internal urinary control

Abstract

Implants to control urinary flow and empty the bladder, and to prevent or treat involuntary urinary retention To provide an embeddable device. The device is adapted to be implanted inside the patient's bladder (30) for draining urine. The expandable member 20 includes a control device 50 for controlling the volume of the expandable member. The control device is adapted to be connected to an expandable member through the wall of the bladder.

Description

[Technical Field]

[0001] The present invention provides urinary control and bladder emptying, thereby preventing or treating involuntary urinary retention. More particularly, the present invention relates to an implantable device for treating a vascular disease after the transfer of hydraulic fluid. The present invention relates to an implantable controlled hydraulic system for draining urine from the bladder. [Background technology]

[0002] Generally, urinary problems caused by spinal cord injury involve involuntary urinary retention, and the condition is Related to urinary tract infection, kidney damage, or urinary tract disorders. The common treatment for urinary retention is continuous catheterization. The catheter method is either a continuous or intermittent catheterization method. In addition to being inconvenient for the patient, catheters are always at risk of infection. Alternatively, the proposed treatment involves muscle contractions to empty the bladder. This includes electrical stimulation of the bladder for the purpose of bladder stimulation (see, e.g., U.S. Patent No. 6,393,323). Qi stimulation is the electrical stimulation of the urethral sphincter to cause it to contract, and pulse stimulation is required. It is necessary to consider the risk of uncontrolled urine spurting through the urethra. No. 4,044,401 includes a totally artificial bladder attached to the urethra and connected to the ureter. It is disclosed that such an artificial bladder is emptied by a manually inflatable balloon. However, a subcutaneously placed reservoir large enough to empty the bladder would be impractically large. become. Summary of the Invention

[0003] From this disclosure, a convenient, manual, and at-will system for patients with a full bladder is provided. It is clear that implantable devices are needed. Furthermore, these devices are located in the most exposed areas. Consider how to better position the implanted part in the body and even replace it with minimal intervention for the patient. The present invention outlines a device that meets these requirements. [Means for solving the problem]

[0004] Generally, the present invention provides an expandable member adapted for implantation inside a patient's bladder. and an implantable control device for controlling the volume of the expandable member. The present invention relates to an apparatus for treating urinary retention in a patient by draining the bladder. The expandable member is adapted to be connected through the wall to the expandable member. When the bladder is opened, urine is expelled from the bladder through the urethra. The control device includes a powered expandable member for assisting the expandable member in expelling urine from the bladder. an actuation device, the apparatus further comprising an external energy transmission device, Energy transmission devices include powered operating devices and energy-consuming implantable devices. This device is capable of operating from outside the patient's body for use in conjunction with operating other parts of the device. It can transmit energy wirelessly into a person's body.

[0005] The term "control device" refers to the hydraulic and electrical components of a device that assists in the evacuation of urine from the bladder. It will become clear from the following description of the present invention that the meaning of the present invention includes both components. These components include implantable components and components intended to be external to the patient. In this context, control devices are defined as both hydraulic control devices and electrical control devices. It will be recognized that the electrical control device can also be divided into the following devices: It may include a power supply and electrical control function as well as a wireless energy receiver. The external control device transmits wireless energy and feedback information from the implanted component. It can also be described as an external control unit that receives the Wherever relevant, in any location describing a control device, Any of the above may be used. In one embodiment, the control device is placed subcutaneously. An internal control unit having at least one of a switch, an electronic circuit, a motor, or a pump. and the internal control unit is operable from outside the patient's body.

[0006] The expandable member is preferably releasable to the control device by a removable coupling. To this end, the expandable member preferably comprises a first connecting portion. , the first coupling portion mates with the second coupling portion of the control device. The expandable member and the control device may be a combination of a male / female section, which may be connected to each other. A releasable joint is provided to allow for easy attachment and detachment of the vise. Snap-lock fittings make transurethral replacement of expandable members simple in minutes The expandable member is then inserted through the urethra with the aid of an appropriate surgical instrument. It is designed to assume an essentially cylindrical, elongated shape that allows for transportation. The component is a bellows that undergoes controlled expansion and collapse when inserted for implantation. Preferably, the expandable member is hydraulically a control device for controlling a bladder operating reservoir for hydraulic fluid; Thus, the expandable member and control device hydraulically extend through the wall of the bladder. To this end, the control device is preferably adapted to be hydraulically connected A bladder operating reservoir is provided, and a tube is provided for transporting hydraulic fluid between the bladder operating reservoir and the cavity. In the form, the removable coupling can be connectable to a hydraulic connection, and the coupling portion provides a connection between the expandable member and the bladder operating reservoir, thus preventing refilling of the bladder. and transferring hydraulic fluid to and from the expandable member to expel urine when the expandable member is filled. can.

[0007] A powered actuation device transports hydraulic fluid between the cavity and the bladder actuation reservoir. In the operating mode, the expandable member is adapted to transport hydraulic fluid from the cavity to the bladder operating reservoir. The actuation device is adapted to be emptied by the pressure exerted by urine in the bladder. The chair uses hydraulic fluid to create a cavity in the expandable member to provide adequate urine pressure for expulsion. Preferably, at least 50 cm of water to allow urine to be excreted. urine pressure can be obtained.

[0008] Preferably, the actuation device is a powered pump. and connecting the actuation device to the injection port to calibrate the amount of hydraulic fluid. The actuation device can be manually operated through an injection port; Can be operated extracorporeally by filling or emptying the injection port .

[0009] Additionally, the apparatus may include an implantable restriction device, The ureter closes when urine leaves the bladder to prevent reflux of urine back to the kidneys. The restriction device is preferably adapted to open and close the ureter. In a suitable embodiment, the actuating hydraulic fluid Fluid is displaced from the bladder operating reservoir, which in turn is connected to the restriction device. The device may include a sealed expandable / collapsible portion for hydraulic fluid to operate. Preferably, these restriction devices open and close through movement of an actuation device.

[0010] The device may also include a restriction device, which acts on the urethral sphincter. These devices are adapted to open and close the urethra to assist patients with impaired function. Restriction devices and wireless controls suitable for the urinary tract of the device are incorporated herein by reference. , European Patent Nos. EP1253880, EP1284691, and EP12633 Further details are provided in issue 55.

[0011] The control device comprises a control assembly that controls other parts of the control device. The control assembly is adapted to be implanted subcutaneously or in the abdominal cavity of a patient in connection with the control assembly. The battery is an energy source that supplies power to the actuating and other energy-consuming parts of the control device. In the context of the system according to the invention, which includes the listed devices, The control assembly further includes a hydraulic fluid reservoir connected to the bladder operating reservoir. An injection port for receiving the

[0012] The device may measure the pressure of urine in the bladder directly or indirectly, such as by measuring the pressure inside the implantable member. may also include an implantable pressure sensor for indirect measurement.

[0013] The hydraulic fluid may contain a drug, such as an antibiotic, to inhibit bacterial growth.

[0014] To further assist in the drainage of urine, the control device may also control the drainage of urine from the bladder. The implant electrically stimulates the bladder muscles to contract, in cooperation with the expandable member. It may be equipped with a device capable of

[0015] Preferably, the electrical stimulation device comprises a plurality of electrode strips attached to the bladder muscles. Equipped with.

[0016] In one alternative, the device may include a second hydraulic connection between the expandable member and the bladder operating reservoir. The second connection, when open, allows the pump to pump Dimensioned so that the volume capacity is significantly greater than the emptying capacity of said second connection. According to this alternative mechanism, the expandable member is hydraulically connected to the second connection. The pressure exerted by urine in the bladder transports the body from the cavity into the bladder working reservoir. In a particular embodiment, the second connection is adapted to be emptied by an expandable Provided when two coupling portions connect to each other when the member is brought together with the control device. In such a system, the main hydraulic connection is closed. When the second connection is open, the second connection can be left open.

[0017] The present invention also relates to a method of implanting the described device, which method comprises the steps of: inserting a tube into the abdomen of a patient; and filling the abdomen with gas through the tube. and inserting at least two laparoscopic trocars into the patient, thereby distending the abdominal cavity. and inserting a camera into the abdomen through one of the trocars. Insert at least one cutting instrument through the local and insert at least one of the bladder incising the area of ​​the bladder, incising the wall of the bladder to create an opening, and dilating placing a control device outside the bladder; and a step of interconnecting the expandable member and the control device by an interconnection device. The method further includes connecting a cavity in the expandable member and a bladder actuation reservoir in the control device. The interconnect device is secured in a position to puncture the bladder wall while providing a hydraulic connection between the interconnect device and the bladder. To achieve this, the method involves creating a tunnel by suturing into the bladder wall itself. Additionally, the method encourages tissue ingrowth and thus at least partially tunnels. and placing a net adapted to cover the surface.

[0018] The present invention also relates to an alternative method of implanting the device, which involves cutting the skin. and incising an area of ​​at least one portion of the patient's bladder. incising the wall to create an opening and placing an expandable member inside the bladder and placing the control device outside the bladder. and interconnecting by an interconnection device. The method further comprises: placing a power source within the body for powering the chair; and and disposing a bladder operating reservoir and an expandable member to drain urine from the bladder. and disposing a pump within the body for pumping fluid between the materials. may also include one step.

[0019] The present invention further includes a method of operating an apparatus, the method comprising: The steps of actuating the valve and increasing the volume of the expandable member and passing the valve through the urethra are performed. and causing urine to drain. The method further comprises: Activating the restriction device and / or restricting the urethra or bladder neck. activating the restriction device to temporarily release the In the method, the control assembly controls the pressure of urine in the bladder or the expandable member. The control assembly can receive a signal from a pressure sensor that measures the pressure. a warning system adapted to give a signal to the user via a wireless remote control or subcutaneously; by a signal from a control unit controlled from outside the patient's body, such as an implantable switch The control assembly may be activated. The method may further comprise: and actuating a pump to transport hydraulic fluid from the reservoir to the expandable member. This can be done.

[0020] The present invention further provides a method for replacing the expandable member of the previously described device for treating urinary retention. The present invention relates to a method for operating an expandable member through the urethra. and releasing the expandable member from the control device. and moving the collapsed expandable member with an instrument. and delivering the expandable member through the urethra to the exterior of the body. inserting the new collapsed expandable member through the urethra; and moving the expandable member to a joint position by a control device; and attaching the assembly to a vise by a removable coupling. The expandable member has two connecting portions, a first connecting portion at a proximal portion of the expandable member and a second connecting portion at a proximal portion of the expandable member. The connection is on the control device.

[0021] The present invention further provides a method for treating urinary incontinence, including any of the modes or embodiments of the device previously described. The present specification relates to a system in which the parts or components of the system are described in the following paragraphs of the specification. They are considered applicable to any of the devices outlined earlier in this specification. It should be done.

[0022] In a preferred embodiment, the system involves the patient manually and non-invasively controlling the device. At least one implantable switch is provided.

[0023] In a preferred embodiment, the system includes a hydraulic actuation device for operating the apparatus. .

[0024] In one embodiment, the system includes a motor or pump to operate the device.

[0025] The system includes a hydraulic device in which an implantable hydraulic reservoir is hydraulically connected to the device. The device may include a hydraulic chair, which may be non-invasively operated by manually pressing a hydraulic reservoir. Such hydraulic devices are adapted to be adjusted to the The device is intended to be connected to the control device and expandable member of the device.

[0026] The system may include a wireless remote control for non-invasively controlling the device. The wireless remote control preferably includes at least one external signal transmitter and / or receiver. a transmitter, preferably for receiving a signal transmitted by an extracorporeal signal transmitter; or an internal signal receiver and / or transmitter implantable in the patient that transmits the signal to an external signal receiver; The wireless remote control preferably includes at least one The radio control signal is modulated in frequency, amplitude, or phase. Alternatively, the wireless remote control device may include: An electromagnetic carrier signal is transmitted to carry the control signal. The control signal is transmitted by an electric field, a magnetic field, an electric field, Alternatively, the control signal may be an analog signal. , digital signals, or a combination of analog and digital signals.

[0027] The wireless energy transmission device of the system is an implantable energy consumption component of the device. The device is adapted to be non-invasively energized with wireless energy. Wireless energy includes sound wave signals, ultrasonic signals, electromagnetic wave signals, infrared signals, visible light signals, ultraviolet signals, ray signals, laser beam signals, microwave signals, radio wave signals, x-ray radiation signals, and gamma ray radiation signals Alternatively, the wireless energy may comprise a wave signal selected from an electric field. , a magnetic field, or a combination of an electric field and a magnetic field.

[0028] With respect to power supply, the system provides power to the implantable energy consuming components of the device. An implantable internal energy source may be provided to provide the power. The external energy source charges the internal energy source with energy transmitted wirelessly. Such systems also transfer energy in a wireless mode to the body. Sense or measure functional parameters related to the energy transfer to charge the ghee source. Sensors or measuring devices and filters that transmit feedback information from inside the patient's body to the outside The system may include a feedback device, and the feedback information may be provided by a sensor. The term relates to a functional parameter sensed by or measured by a measurement device.

[0029] The system generally described is a flow chart that transmits feedback information from inside the patient's body to outside the body. The device may further include a feedback device, the feedback information being transmitted to the bladder. The patient's physical parameters, such as the pressure in the blood, and some of the functional parameters of the device At least one related.

[0030] Generally, the system further comprises a sensor and / or measurement device, and an implantable The internal control unit may include an internal control unit that detects the the patient's physical parameters measured by the device or by a measuring device, as well as the Functions related to the equipment sensed by a sensor or measured by a measuring device and controlling the device in response to information relating to at least one of the parameters. The parameter is pressure, such as pressure in the bladder or movement.

[0031] Generally, the system further includes an external data communicator and an implanted device in communication with the external data communicator. and an intra-body data communicator capable of communicating data related to the device or the patient. The data is provided to an external data communicator and / or the external data communicator transmits the data to an internal It is supplied to the data communication device.

[0032] In embodiments where the system includes an actuation device for operating the device, the actuation device The actuator may include a servo mechanism, which controls the actuator device to operate the device. This reduces the force required to operate the actuator, so that the actuation device acts longer and achieves a defined motion. It is designed to extend the time for work.

[0033] The system includes an actuation device that operates the device and an energy transmission device that transmits wireless energy. In an embodiment comprising an energy transmission device, the wireless energy is transmitted by the energy transmission device. This energy is transmitted wirelessly, i.e. the device is directly powered. used in a state directly to the actuation device to generate kinetic energy for the operation of the device It is possible to supply power to the

[0034] When the system includes a wireless energy transmission device, the energy transmission device The energy that converts the transmitted wireless energy from the first form to the second form energy is then The device may further comprise an energy conversion device. - Converting the first form of energy transmitted by the transmitting device into the second form of energy When the implantable energy-consuming component of the device is directly supplied with the second form of energy, In this regard, the second form of energy is DC, pulsating DC, and The system so described includes at least one of the following: The second form of energy may be used to charge the accumulator. Generally, the energy in the first or second form is , magnetic energy, kinetic energy, acoustic energy, chemical energy, radiant energy , electromagnetic energy, light energy, atomic energy, thermal energy, non-magnetic energy, Non-kinetic energy, non-chemical energy, non-acoustic energy, non-atomic energy, and non The energy source includes at least one of thermal energy.

[0035] The system described above in general terms may further include at least one voltage level guard and and / or at least one constant current guard. It is possible.

[0036] When the system includes a wireless energy transmission device, a control device for controlling the transmission of wireless energy from the and an implantable internal energy receiver for receiving the energy from the internal energy source. - The receiver transmits the received energy directly or indirectly to the implantable energy consumption device. The system is further connected to the energy consuming components to supply the energy consuming components. Furthermore, the energy received by the internal energy receiver and the implantable energy Determine the energy balance between the energy used for the energy consumption components a determining device adapted to determine the Wireless energy transmission from an external energy transmission device based on the measured energy balance In one mode, the decision device detects changes in energy balance and controls the transmission of energy. The control device is adapted to detect changes in energy balance. In another mode, the determination device controls the transmission of wireless energy based on the The energy received by the energy receiver and the implantable energy consumption structure of the device. and adapted to detect a difference between the energy used for the component and the energy used for the control device. The device controls the transmission of wireless energy based on the detected energy difference.

[0037] In a particular embodiment, when the system comprises a wireless energy transmission device, The energy transmission device comprises a coil positioned outside the human body. Then, the system further comprises: an implantable energy receiver placed in the human body and a wireless energy transmitting device; and an electrical circuit for supplying power to the external coil by electrical pulses. The electrical circuit changes the power of the transmitted wireless energy. a first time interval between successive rising and falling edges of the electrical pulses, and and / or adapted to vary the second time interval between successive falling and rising edges. At that time, the energy receiver that receives the transmitted wireless energy is changed. In one mode, the electrical circuitry has a first and / or second time interval. Adapted to deliver electrical pulses so that the signal remains unchanged except for the In another mode, the electrical circuit has a time constant and operates only within the range of the first time constant. adapted to vary the first and second time intervals, thus varying the first and / or second time intervals; Alternatively, when the length of the second time interval is changed, the power transmitted on the coil is changed. .

[0038] Embodiments of a system including a feedback device as described above may further include: An implantable internal energy receiver may be provided to receive wireless energy. The energy receiver preferably includes a first internal coil and a first internal coil connected to the first coil. and an electronic circuit. The system further includes an external energy transmission device for transmitting wireless energy. The external energy transmitter preferably includes a second external coil and a second coil. and a second electronic circuit connected to the second external coil of the energy transmitter. The system transmits wireless energy that is received by a first coil of a wireless receiver. The system further switches on and off the connection of the first internal coil to the first electronic circuit. The power switch may include a first body for the first electronic circuit. When the inner coil is switched on and off, the feed of the charge on the first coil The back information is transmitted to the external energy source in the form of a change in the impedance of the load of the second external coil. Alternatively, in such systems, the feedback information is a feedback device to communicate the amount of energy received by the first coil to the The second electronic circuit may include a decision device, the decision device being adapted to receiving feedback information and obtaining a coupling coefficient between the first coil and the second coil; The amount of energy transmitted by the second coil is multiplied by the amount of energy received by the first coil. The energy transmitter preferably compares the obtained coupling In one embodiment, the second external coil adjusts the transmitted energy in response to the coefficient. , the first internal coil to establish the optimal movement of the second coil where the coupling coefficient is maximized. In another embodiment, the second external coil is adapted to move relative to the coupling The feedback information of the decision device is transmitted to realize the coefficient before it reaches its maximum. It is adapted to calibrate the amount of energy.

[0039] The invention will now be described in more detail by way of non-limiting example with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0040] [Figure 1] 1 is a schematic diagram of a patient implanted with a device of the present invention. [Figure 2a] 1 is a schematic diagram of an embodiment of an implantable device. [Figure 2b] 2b is a portion of the device of FIG. 2a showing removable joints between parts of the device. [Figure 3] 2b is a diagram of the device of FIG. 2a in an operational mode for draining urine from the bladder through the urethra. [Figure 4] 2b is a view of the device of FIG. 2a when the bladder is being refilled with urine, further illustrating a particular embodiment in which the bladder operating reservoir is hydraulically connected to the ureteral restriction device. FIG. [Figure 5] 1 shows another embodiment of the device. [Figure 6] 1 shows a system according to the present invention, including a device according to the present invention, implanted in a patient. [Figure 7] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 8] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 9] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 10] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 11] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 12] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 13] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 14] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 15] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 16] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 17] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 18] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 19] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 20] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 21] 2A-2C illustrate various embodiments of a system for wirelessly powering the device shown in FIG. 1; [Figure 22] FIG. 7 is a schematic block diagram illustrating a mechanism for providing the precise amount of energy used for operation of the device shown in FIG. 6. [Figure 23] 1 shows a schematic representation of an embodiment of a system in which the device is powered by wired energy. [Figure 24] FIG. 7 is a detailed block diagram of a mechanism for controlling the transmission of wireless energy used for the operation of the device shown in FIG. 6. [Figure 25] 20 is a circuit for the mechanism shown in FIG. 19 according to a possible implementation. [Figure 26]1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 27] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 28] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 29] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 30a] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 30b] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 30c] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 31] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 32a] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 32b] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. [Figure 32c] 1 illustrates various methods for hydraulically or pneumatically powering a device implanted in a patient. DETAILED DESCRIPTION OF THE INVENTION

[0041] Referring to Figures 1 and 2a, the device has a cavity for containing hydraulic fluid. The expandable member 20 is accessible from the ureters 32A, 32B. The control device 50 is disposed inside the bladder 30, which contains urine. The control device 50 includes a control assembly 52. The control assembly 52 is connected to a bladder operating reservoir 54 for hydraulic fluid, The actuation reservoir 54 transfers hydraulic fluid between the bladder actuation reservoir 54 and the expandable member 20. The pump 5 is connected to the expandable member by an interconnection device 56 for delivery. 3 aids in the transport of fluid. The interconnection device 56 is inserted through a surgical incision in the wall of the bladder. It is a tube-shaped device that is created by a tunneling technique in which the bladder wall is sutured to itself. The interconnect device allows for tissue ingrowth. In FIG. 2a, the interconnect device is supported by a net 58 that sealingly fastens the device to the substrate. The nozzle 56 is attached to a removable coupling 55 and is connected to the nozzle 56 as described below in FIG. 2b. The bladder operating reservoir is then attached to the expandable member by its joint 55. The control assembly 52 is positioned within the patient and includes an actuating pump 529 for hydraulic fluid, an actuating The apparatus includes an energy source 521 that drives pumps and other energy-consuming parts of the apparatus. The external energy supply device 60 includes a plurality of functional elements necessary for the operation. to the energy conversion device 522, thus supplementing the energy source 521. The external control unit 70 controls the internal control unit 523 to operate the device. The pressure sensor 57 also communicates wirelessly with the sensor control function 524 of the control assembly. The control assembly 52 includes an internal portion 52A that includes the functions mentioned, and an infusion port 52B. The external portion 52B includes a port 521B and an external portion 52B including a manually operable switch 522B. A control device is placed subcutaneously or in the abdominal or pelvic region or any other suitable location within the body. One or more portions of the urethral sphincter may be implanted. It is adapted for patients with complications of muscle closure. requires high pressure (approximately 60-80 cm of water column) to force urine out of the bladder. This can cause urine to back up through the ureters 32A, 32B, which can lead to kidney problems. To prevent these complications, the control device must be The restriction devices 59A, 59B temporarily restrict the ureter. and configured to close the ureter during the expulsion of urine by the expandable member. The restriction device is temporarily deflated during drainage and controlled by the control assembly. Suitable mechanically or hydraulically operated restriction devices and their controls are Described in more detail in EP1253880, EP1284691, and EP1263355 It should be understood that the pressure of urine in the ureter is normally about 50 cm of water, but in the short term The pressure increase during this time is unlikely to cause kidney damage, and therefore the restriction device 59A and and 59B may be omitted.

[0042] When the pump 53 is not pumping to fill the expandable member, the bladder actuation lever If the passage 56 between the reservoir and the expandable member is free, the expandable member will In another alternative, the pump 53 may be started in stages, e.g. The expandable member may be pressure controlled by any other input sensor, such as those mentioned elsewhere. A second connection 56B is introduced between the expandable member 20 and the bladder operating reservoir 54. The second connection, when closed, allows the member 20 to be inserted into the bladder operating reservoir. The pumping volume capacity is adapted to allow the delivery of fluid to the second connection. If the emptying capacity of the bladder is much greater than the capacity of the bladder pump, a pump 53 may be used to pump the bladder from the bladder reservoir 54. This connection can be left open at all times when fluid is being delivered to element 20. The introduction of a second connection is to be considered an optional alternative to the device.

[0043] FIG. 2b shows the removable coupling 55 of FIG. 2a and its two coupling parts 55A and 55B. 5B. The first coupling portion 55A is part of the control device 50, The second coupling portion 55B is connected to the bladder operating reservoir 54. The second coupling portion 55B is connected to the expandable member 20. The two coupling portions are arranged to connect the expandable member to the control device 50. It is easily attachable and detachable for easy installation or removal. Therefore, the expandable member can be easily replaced by transurethral intervention with appropriate instruments. To that end, the expandable member is preferably essentially cylindrical in shape to penetrate the urethra. An elongated shape can be envisaged. In Figure 2b, a second Connection 56B is also shown.

[0044] Referring to Figures 2a and 3, the device is responsive to signals from a remote control device 70. The control assembly 54 is operable by actuating the pump. The control assembly is connected to a pressure sensor 57 for monitoring the pressure of urine in the bladder. For example, determining the stretch or curvature or pressure of the wall of the bladder, or Several different types of input sensors, for example to sense volume or pressure in the bladder Often, these sensors can be used to tell you when it's time to empty your bladder. This simply indirectly empties the bladder by giving the patient a warning to The remote control 70 may be configured to notify the user when the bladder has been emptied. Control or communicate through the body used as a wire or by wireless communication The pump can then control a subcutaneous switch 525 to pump hydraulic fluid to the bladder. Transport from the bladder operating reservoir 54 through the interconnection device 56 into the cavity of the expandable member 20 This causes the bladder volume to increase, forcing the bladder through the urethra with pressure that overcomes the closing force of the urethral sphincter. During this operation, the control assembly The restrictor 59A, 59B is actuated to close the restrictor devices 59A, 59B to prevent reflux of urine in the ureter. When the drain run is finished and the actuating pump is stopped, the restriction devices 59A, 59B The pressure sensor then releases the pressure, allowing urine to refill the bladder. When the expandable member 20 is ready for a new run, which is monitored by the The pressure of the urine causes it to collapse and maintain the shape shown in Figure 2.

[0045] Some patients with urinary retention also have urinary incontinence. In these cases, the system has a separate urethral compartment. The restrictive device contains a slit muscle and closes the urethra until the patient wants to urinate. If you have a bladder, the pressure inside your bladder will make it easier to empty your bladder because you won't need to force your sphincter open. In this case, the restrictive devices 59A and 59B may be omitted. It can be omitted.

[0046] The bladder operating reservoir 54 may be located anywhere in the body, preferably in the abdominal cavity, and The amount of fluid in the bladder reservoir can be adjusted by placing it on the bladder or in the pelvic area. and a subcutaneous reservoir 521B located within reach of the needle of a special injection port in the body. 26 and can be calibrated with fluid. Omitting the subcutaneous reservoir. Alternatively, only the fill port may be used to fill and empty the expandable member. In the described embodiment, in order to control the duration / force of the urinary excretion process, e.g. a pressure sensor that measures the pressure of urine, or more simply, the pressure inside the expandable member of the bladder The data from the sensor could be used to control the actuating pump via logic in the control assembly. The expandable member may be stretchable within the range of pressures used within the member. It should be noted that the urinary tract may be merely flexible, rather than rigid. 2 (without the control device 50). Next, the restriction devices 59A, 59B are The tubes 32A and 32B are closed and the urethral sphincter 59C is opened. 3 with hydraulic fluid returning to the bladder operating reservoir 54. The urethral sphincter devices 59A and 59B are open and the urethral sphincter 59C is closed. The restriction device for the bladder is hydraulically actuated by hydraulic fluid from a special portion of the bladder operating reservoir. Also shown is an embodiment in which the pressure of urine applied to the expandable member causes the remainder of the reservoir to expand. When the reservoir is filled, hydraulic fluid is displaced from the reservoir to operate the restriction device. Figure 5 shows another embodiment of the device of Figure 2a, in which the bladder actuation link The reservoir 54 is a control actuator that operates to pump hydraulic fluid to the expandable member 20. It is hydraulically connected to pump 527 of assembly 52.

[0047] It will be understood that modifications to the described embodiments may be made within the scope of the appended claims.

[0048] 6, the apparatus 10 of the present invention, as generally illustrated in FIGS. 1 to 5, A system for treating urinary incontinence is shown, the system being placed in the patient's abdomen. An energy conversion device 302 provides power to energy consuming components of the device through power supply lines 303. The device 10 is adapted to deliver energy non-invasively via an external energy transmission device 304 that supplies at least one wireless energy signal; The implantable energy-transforming device 1002 transmits energy by wireless energy. converts energy from the gy signal into electrical energy that is supplied to the power supply line 1003 do.

[0049] Wireless energy signals include sound wave signals, ultrasonic signals, electromagnetic wave signals, infrared signals, and visible light signals. , ultraviolet signals, laser beam signals, microwave signals, radio wave signals, x-ray radiation signals, and gun The signal may include a wave signal selected from a radiation signal or a wireless energy signal. The signal can include an electric field or a magnetic field, or a combination of electric and magnetic fields.

[0050] The wireless energy transmission device 1004 is a carrier signal for transmitting the wireless energy signal. These carrier signals can be digital, analog, or It may include a combination of digital and analog signals, in which case wireless energy The signal can be analog or digital, or a combination of analog and digital signals. This includes.

[0051] Generally, an energy-transforming device 1002 is connected to an energy-transmitting device 1004. The first form of wireless energy transmitted by the The implanted device 10 is provided for converting the first energy into a different second form of energy. The energy-transforming device 1002 is operable in response to two forms of energy. The first form of energy transmitted by the energy transmission device 1004 is converted into a second form of energy. When converted to energy, the second form of energy can directly power a device. The system may further include an implantable accumulator, The second form of energy is at least partially used to fill the accumulator.

[0052] Alternatively, wireless energy transmitted by the energy transmission device 1004 may be used. Then, when wireless energy is being transmitted by the energy transmission device 1004, The system can directly power the device, as described in more detail below. and an actuation device for operating the device, the energy transmission device 10 Use the wireless energy transmitted by the 04 to directly power the operating device. , which can generate kinetic energy for the operation of the device.

[0053] The first form of wireless energy may comprise sound waves, and the energy-transforming device 100 2 may include a piezoelectric element for converting sound waves into electrical energy. The energy is supplied by direct current or pulsating direct current or a combination of direct current and pulsating direct current, or It can contain electrical energy in the form of AC or a combination of DC and AC. The device includes electrical components that are powered by electrical energy. The embeddable electrical component has at least one voltage level connected to the electrical component of the device. The detector may be a constant current guard or at least one constant current guard.

[0054] Optionally, one of the energy in the first form and the energy in the second form is a magnetic energy. Energy, kinetic energy, acoustic energy, chemical energy, radiation energy, electromagnetic energy The energy may include energy, light energy, atomic energy, or thermal energy. Preferably, one of the first form of energy and the second form of energy is non-magnetic, non- It is kinetic, non-chemical, non-acoustic, non-nuclear, or non-thermal.

[0055] An energy transmission device is attached to the outside of the patient's body to emit electromagnetic wireless energy. It can be controlled and the emitted electromagnetic wireless energy can be used to operate the device. Alternatively, the energy transmission device may be configured to emit non-magnetic wireless energy. Controlled, emitted non-magnetic wireless energy from outside the patient's body is used to operate the device. Used.

[0056] The external energy transmission device 1004 also includes a wireless remote control device. The device has an extracorporeal signal transmitter that transmits wireless control signals for non-invasively controlling the device. The control signal is received by an implanted signal receiver, which receives the control signal from the implanted energy It may be incorporated into the Ghee conversion device 1002 or may be separate therefrom.

[0057] The radio control signal may be a frequency, amplitude, or phase modulated signal, or a combination thereof. Alternatively, the wireless control signal may include an analog signal or a digital signal, Or a combination of analog and digital signals. Alternatively, the wireless control signal may also include an electric field. or magnetic fields, or a combination of electric and magnetic fields.

[0058] The wireless remote control device can transmit a carrier signal that carries a wireless control signal. The carrier signal may be digital, analog, or a combination of digital and analog signals. The control signal may be an analog signal or a digital signal, or If the wireless remote control device includes a combination of digital and digital signals, the wireless remote control device preferably includes a digital The signal carries an electromagnetic carrier signal that carries a digital or analog control signal.

[0059] FIG. 7 shows the system of FIG. 6 in more schematic block diagram form, and includes device 10 and an energy conversion device that supplies power to the device 10 via a power supply line 1003. 1002 and an external energy transmission device 1004. The patient is shown schematically with vertical lines. The skin 1005 separates the inside of the patient's body to the right of the line from the outside of the patient's body to the left of the line. do.

[0060] FIG. 8 shows an inversion of the configuration of an electrical switch 1006 operable by, for example, polarization energy. 7, except that a device is also implanted in the patient to invert the apparatus 10. 1 shows an embodiment of the present invention identical to that of the first embodiment, in which the switch is operated by polarization energy. In this case, the wireless remote control of the external energy transmission device 1004 transmits the polarization energy. The implanted energy-transforming device 1002 transmits a wireless signal to the electric switch 1002. The radio polarization energy is converted into a polarization current to operate the implantable energy device. When the polarity of the current is changed by the conversion device 1002, the electrical switch 1006 The functions performed by the device 10 are reversed.

[0061] FIG. 9 shows an actuation device 1007 implanted in a patient for operating the apparatus 10. except that it is provided between the embedded energy transforming device 1002 and the apparatus 10. 8 shows an embodiment identical to that of FIG. 7. Such an actuation device may be an electric servo motor. The motor 1007 may be any form of motor. The remote control device 1004 transmits a wireless signal to a receiver in the implanted energy-transforming device 1002. When transmitting, it is powered by energy from the implanted energy-transforming device 1002 will be done.

[0062] FIG. 10 shows an assembly including a motor / pump unit 1009 and a fluid reservoir 1010. 1008, except that the actuation device is implanted in the patient. 7, in which the device 10 is hydraulically operated, i.e. That is, hydraulic fluid is pumped by the motor / pump unit 1009 to operate the device. Fluid is pumped from reservoir 1010 through conduit 1011 to device 10 to start the device. The fluid is removed from the device 10 by the motor / pump unit 1009 to return it to its operating position. The blood is pumped back into the implantable energy-transforming device 100. 2 powers the motor / pump unit 1009 via power supply line 1012 To do this, the radio energy is converted into a current, for example a polarization current.

[0063] Instead of a hydraulically operated device 10, the actuation device may comprise a pneumatic actuation device. In that case, the hydraulic fluid may be pressurized air used for regulation, and the fluid An air chamber is used instead of a reservoir.

[0064] In all these embodiments, the energy-transforming device 1002 is This includes a rechargeable accumulator such as a battery or capacitor that is charged by and supply energy to any energy-consuming part of the system.

[0065] Alternatively, instead of the wireless remote control described above, multiple devices may be used by the patient. Implants, which are often contacted indirectly, for example by a push button placed under the skin Manual control of the formula portion can be used.

[0066] FIG. 11 shows an external energy transmission device 1004 having a wireless remote control device, In this case, the device comprises a hydraulically operated device 10 and an implantable energy-transforming device 1002, A hydraulic fluid reservoir 1013 and a motor / pump unit, all of which are implanted in a patient. 1009 and a reversing device in the form of a hydraulic valve shift device 1014. Of course, hydraulic action can be achieved by simply changing the direction of pumping. It can also be easily implemented, thus eliminating the need for hydraulic valves. The device may be a separate device from the external energy transmission device or may be included in it. The motor of the motor / pump unit 1009 is an electric motor. In response to a control signal from a wireless remote control of the device 1004, the implanted energy converter The conversion device 1002 operates on energy from the energy carried by the control signal. 1009, which supplies power to the motor / pump unit 1009. 1009 distributes hydraulic fluid between hydraulic fluid reservoir 1013 and device 10. The remote control of the energy transmission device 1004 determines whether fluid is being transferred to the motor / Pumping hydraulic fluid from reservoir 1013 to device 10 by pump unit 1009 In one direction, the fluid flows through the motor / pump unit 10 to return the device to the starting position. 10. The hydraulic fluid is pumped from the device 10 back to the hydraulic fluid reservoir 1013 by the Hydraulic valve shift to shift the flow direction of hydraulic fluid between one opposite direction Controlling the device 1014.

[0067] FIG. 7 shows an external energy transmission device 1004 with a wireless remote control and an apparatus 10 an implantable energy conversion device 1002; and an external energy transmission device 1004. an implanted internal control unit 1015 controlled by a wireless remote control device; An embodiment of the present invention comprising an accumulator 1016 and an implantable capacitor 1017 is shown. The internal control unit 1015 controls the accumulator 1014 which supplies energy to the device 10. 016, storing the electrical energy received from the implanted energy-transforming device 1002; In response to a control signal from the wireless remote control device of the external energy transmission device 1004, The internal control unit 1015 then releases the electrical energy from the accumulator 1016. and transmits the emitted energy via power lines 1018 and 1019 or The electrical energy is transferred from the implanted energy conversion device 1002 to the power line 1020, and the current is stabilized. a capacitor 1017 for stabilizing the power supply voltage, a power line 1021, and a power line 1022 for the operation of the device 10. Communicate directly via 019.

[0068] The internal control unit is preferably programmable from outside the patient's body. In an embodiment, the internal control unit may be configured to monitor the patient's sleep habits based on a pre-programmed time schedule or a patient-specific time schedule. Sensing any possible physical parameter of a person or any functional parameter of a system The device 10 may be programmed to adjust according to input from any sensor.

[0069] According to an alternative, capacitor 1017 in the embodiment of Figure 12 can be omitted. According to another alternative, the accumulator 1016 in this embodiment can be omitted. .

[0070] FIG. 13 shows a battery 1022 for providing energy for the operation of the device 10; An electrical switch 1023 for switching the operation of the device 10 is also implanted in the patient. 7 except that the battery 1022 is not in use. From the off mode, the battery 1022 is switched on to provide energy for the operation of the device 10. To switch to the on mode, the electric switch 1023 is controlled by a remote control device. and the energy delivered by the implanted energy-transforming device 1002 can So it can also be made to work.

[0071] FIG. 14 shows a diagram of an external energy transmission device 1004 controlled by a wireless remote control device. 13, except that an internal control unit 1015 is also implanted in the patient. The same embodiment is shown, in which the electrical switch 1023 is connected to an implanted energy conversion device. The energy supplied by the device 1002 controls the body via a wireless remote control. The control unit 1015 is prevented from turning off when the battery is not in use. The remote control device is configured to discharge electrical energy from the battery 1022 for operation of the device 10. The device is switched to a standby mode in which it can control the internal control unit 1015. It works.

[0072] In FIG. 15, an accumulator 1016 is used instead of a battery 1022, and an implantable 14, except that the interconnections of the components are different. In this case, the accumulator 1016 receives energy from the implanted energy-transforming device 1002. The external energy transmission device 1004 is controlled by a wireless remote control device. In response to the control signal, the internal control unit 1015 determines whether the accumulator 1016 is being used. From the off mode, the accumulator 1016 stores energy for the operation of the device 10. The electric switch 1023 is controlled to switch to the ON mode for supplying the electric power. The accumulator may be combined with a capacitor, and a capacitor may be used instead of the accumulator. It's fine.

[0073] In FIG. 16, a battery 1022 is also implanted in the patient, and the interconnection of the implanted components 16 shows an embodiment identical to that of FIG. 15 except for the external energy transmission device. In response to a control signal from the wireless remote control device of the device 1004, the internal control unit 101 5. From the off mode, in which the battery 1022 is not being used, the battery 1022 is turned off. 10. Switch on the electric switch to the ON mode to supply electric energy for operation. accumulator 1016 to deliver energy to operate switch 1023; Control.

[0074] Alternatively, the electrical switch 1023 may be powered by a wireless remote control. The wireless remote control device is used to prevent the battery 1022 from being controlled in such a way that From the off mode, the wireless remote control device does not require electrical energy for the operation of the device 10. The battery 1022 can be controlled to supply power to the accumulator 1021. It can be powered by energy provided by the actuator 1016.

[0075] Switch 1023 and all other switches in this application are in the broadest embodiment. This should be interpreted as a transistor, MCU, MCPU, ASIC, FPGA or DA converter or any other electronic component or circuit This means that the power can be turned on and off. Preferably, the switch can be controlled from outside the body. It may be controlled by a computer or by an implanted internal control unit.

[0076] FIG. 17 shows a motor 1007 and a mechanical reversing device in the form of a gear box 1024. An internal control unit 1015 that controls the gear box 1024 is also implanted in the patient. 13 except that the internal control unit 1015 is , a gearbox is provided to reverse the function performed by the (mechanically operated) device 10. Controlling the 1024x1024. Even simpler, switching the direction of the motor electronically. The gearbox, interpreted in a wider embodiment, is designed to favour longer operating strokes. This can represent a force-saving servo mechanism for the actuation device.

[0077] FIG. 18 shows a cross-sectional view of a device similar to the embodiment of FIG. 24 except for the interconnection of the implantable components. In this case, the internal control unit 1015 is An accumulator 1016, suitably a capacitor, activates an electrical switch 1023 to turn on. When switching to the mode, power is provided by the battery 1022. When 1023 is in the on mode, the internal control unit 1015 controls the energy device 10 A battery 1022 that may or may not provide energy for operation. It is possible to control the

[0078] Figure 19 shows possible implantable components of the device to achieve various communication options. The combination is shown in schematic form. Essentially, it is comprised of the device 10, an internal control unit 1015, and a motor. or a pump unit 1009 and an external energy transmission device including an external wireless remote control device. As already explained above, the wireless remote control device is an internal control unit. The control signal is received by the internal control unit 1015. It controls the various implanted components of the device.

[0079] Preferably, a feedback device comprising a sensor or measuring device 1025 The device may be implanted in a patient to sense a physical parameter of the patient. The data includes pressure, volume, diameter, elongation, extension, expansion, movement, curvature, elasticity, muscle contraction, nerve instability. At least one selected from the group consisting of pulse, body temperature, blood pressure, blood flow, heart rate, and respiration The sensor may sense any of the physical parameters listed above, for example: The sensor may be a pressure sensor or a motility sensor, or may be any sensor that senses a function parameter. The sensor 1025 can be configured as follows: Electricity, any energy that can be connected to each other to transfer energy to fill Electrical parameters, pressure, volume, diameter, elongation, extension, expansion, movement, curvature, elasticity, temperature and flow. can.

[0080] The control unit is connected to the internal control unit or, preferably, to the external control unit via the internal control unit. The energy transfer system, or receiver and Feedback can be sent outside the body via a separate communication system with a transmitter. Cut.

[0081] The internal control unit 1015 or the external wireless energy transmission device 1004 The remote control device can control the device 10 in response to signals from the sensor 1025. A transceiver is provided to transmit information about the sensed physical parameters to an external wireless remote control device. The wireless remote control may be combined with a signal transmitter or transmitter. The internal control unit 1015 may be equipped with a signal receiver or transceiver. Alternatively, the wireless remote control device may comprise a signal receiver or transceiver. The internal control unit 1015 may include a signal transmitter or transceiver. The above transceiver, transmitter, and receiver can be used to Information or data relating to the patient's condition can be sent from inside the patient's body to outside the body.

[0082] A motor / pump unit 1009 and a power supply for the motor / pump unit 1009 If a battery 1022 is implanted, information about charging the battery 1022 For more accuracy, the battery or accumulator can be used as feedback. When charging a battery with energy, feedback information is sent regarding the charging process. and alter the energy supply accordingly.

[0083] FIG. 20 illustrates an alternative embodiment in which the system 10 is adjusted from outside the patient's body. The 00 is equipped with a battery 1022, which is powered via a subcutaneous electrical switch 1026. The device 10 is then connected to the subcutaneous switch. and thereby non-invasively switching the operation of the device 10 on and off. The illustrated embodiment is a simplification and may be implemented in an internal control unit or in the context of this application. It will be appreciated that additional components may be added to the system, such as any other portion disclosed. Two subcutaneous switches can also be used. In the preferred embodiment, one implanted The switch sends information to the internal control unit to perform a predetermined action, and the patient Pressing the switch again will reverse the action.

[0084] FIG. 21 shows a system 1000 including a hydraulic fluid reservoir 1013 hydraulically connected to the device. 1 shows an alternative embodiment in which the device is provided with a hydraulic reservoir connected to the device. Invasive adjustments are made.

[0085] The system includes an external data communicator and an implantable internal device that communicates with the external data communicator. The internal communicator may include a data communicator that communicates with the external data communicator about the device or the patient. and / or the external data communicator supplies data to the internal data communicator. do.

[0086] FIG. 22 shows a schematic of the system's mechanism, which includes an implantable energy A precise amount of energy is delivered to an implantable internal energy receiver 1002 connected to the consuming component. At least one function parameter of the device or system is adjusted to provide the desired energy. a patient's body from within the patient's body to provide feedback information regarding the patient's physical parameters; Such an energy receiver 1002 can transmit information to the outside. or energy conversion devices. Briefly, wireless energy is , transmitted from an external energy source 1004a located outside the patient and The energy is received by the internal energy receiver 1002. The energy received via switch 1026 is then fed directly or Energy balance is determined by the amount of energy received by the body. The energy received by the receiver 1002 and the energy used for the device 10 Then, the wireless energy transmission is determined based on the determined energy balance. Therefore, the energy balance is properly controlled to prevent excessive temperature rise. It will then accurately indicate the exact amount of energy required, sufficient to operate the device 10.

[0087] In Figure 23, the patient's skin is indicated by vertical line 1005. Here, the energy The receiver is an energy receiver located within the patient's body, preferably just beneath the patient's skin 1005. The implantable energy-transforming device 1002 is generally 2, placed in the abdomen, thorax, fascia (e.g., of the abdominal wall), subcutaneously, or any other suitable location. The implanted energy-transforming device 1002 can be connected to an external energy source 10 04a, and is adapted to receive wireless energy E transmitted from the outside of the body. The energy source 1004a is applied to the patient's skin 1002 in the vicinity of the implanted energy-transforming device 1002. 10. The external energy transmission device 1004 is located outside the body 1005.

[0088] As is well known in the art, wireless energy E is generally referred to as extracorporeal energy The primary coil is located in the source 1004a and the implantable energy-transforming device 1002. Any suitable transcutaneous energy transfer (transcutaneous energy transfer) device may be used, such as a device including an adjacent secondary coil positioned adjacent to the The TET (Thermal Emission Test) device can transmit current through a primary coil. When the voltage is applied to the secondary coil, energy in the form of a voltage is induced in the secondary coil, e.g. This is stored in an implanted energy source such as a rechargeable battery or capacitor. It can be used to power implanted energy consuming components of the device. The present invention is generally not limited to any particular energy transfer technique, TET device, or energy It is also not limited to a gyre source, and any type of wireless energy can be used.

[0089] The amount of energy received from the implanted energy receiver is measured by the implanted components of the device. The term "energy used" can then be used to "Energy" is understood to also include energy stored by implanted components of the device. The control device includes an external control unit 1004b, and the external control unit 1004 b adjusts the amount of energy transferred based on the determined energy balance. The external energy source 1004a is controlled to deliver the correct amount of energy. , the energy balance and the amount of requested energy are It is determined by a determination device including a connected implanted internal control unit 1015. Therefore, the characteristics of the device 10 may be measured by suitable sensors or the like (not shown). The internal control unit 1015 can be configured to receive various measurements, and the device This reflects to some extent the amount of energy required for proper functioning of the patient. the current state of the patient, and appropriate measuring devices to provide parameters that reflect the patient's condition. or can be detected by a sensor. The parameters may include the current state and physical state of the device 10, such as power consumption, operating mode and temperature. It may relate to the patient's condition as reflected in parameters such as temperature, blood pressure, heart rate, and respiration. Other types of patient physical parameters and device functional parameters are described separately.

[0090] Additionally, an energy source in the form of an accumulator 1016 may optionally be added to the system 10 after The control unit 1015 controls the implanted energy storage device 1016 to store received energy for use in the Alternatively, or in addition, the device may be connected to an energy conversion device 1002. It is also possible to measure the characteristics of such accumulators which reflect the amount of energy required. A battery capable of storing electricity can be used instead of the accumulator, and the measured characteristics are Current state of the battery, including energy consumption, voltage, temperature, and any other electrical parameters To provide sufficient voltage and current to the device 10 and to prevent overheating, The exact amount of energy, i.e. not too little and not too much, is delivered to the implanted energy converter. It is clear that the battery should be optimally charged by receiving it from the device 1002. It is to be understood that the accumulator may be a capacitor with corresponding characteristics.

[0091] For example, periodically measuring the characteristics of the battery to determine its current condition. This can then be stored as status information in suitable storage means in the internal control unit 1015. Therefore, whenever a new measurement is made, it can be stored accordingly. This allows the stored information on the battery status to be updated. It monitors the battery's health by transferring the precise amount of energy needed to keep it in optimal condition. can be "calibrated".

[0092] Therefore, the internal control unit 1015 of the decision device may be the sensor or measuring device, or the patient, or the implanted energy source, if used; or any combination thereof, based on measurements made on energy balance and / or or the current energy demand (energy per unit time or stored energy) The internal control unit 1015 is further adapted to determine the internal signal transmission. The internal signal transmitter 1027 is connected to the determined required energy. A control signal reflecting the amount of energy is transmitted to an external signal receiver 1004b connected to the external control unit 1004b. 004c. Then, in response to the received control signal, The amount of energy transmitted from the energy source 1004a can be adjusted.

[0093] Alternatively, the determination device may include an external control unit 1004b. Alternatively, the sensor measurements can be transmitted directly to the external control unit 1004b. Energy balance and / or current energy requirement are recorded by the external control unit 100. 4b, and therefore, the internal control unit 1015 The functions described above can be integrated into the external control unit 1004b. The unit 1015 can be omitted and the sensor measurements can be sent directly to the internal signal transmitter 1027. The internal signal transmitter 1027 transmits these measurements to the external signal receiver 1004. c and the external control unit 1004b. Energy balance and current The amount of energy required can be determined.

[0094] Therefore, the current solution, based on the mechanism of FIG. 22, is to use the field of information indicating the required energy. This is the measured energy of the implanted device compared to the received energy. - the amount of energy compared to the rate of energy used by the consuming component, It is based on actual energy use relative to energy difference or energy reception percentage. This is more effective than previous solutions as it allows the device to be used in conjunction with other devices such as power sources, consumer or implanted energy sources. The received energy can be used for energy storage in the and tools to further determine the actual energy balance if needed. However, the different parameters explained above will be used to operate the device. These parameters are essentially required for the actions that take place in the body to stomach.

[0095] By using any suitable signaling means, such as radio, IR (infrared) or ultrasonic signals. , the internal signal transmitter 1027 and the external signal receiver 1004c are implemented as separate units. Alternatively, the same transmission techniques can be used inversely to the energy transfer. The internal signal transmitter 1027 and the external signal receiver 1004c are connected to each other to transmit a control signal in a direction 1002 and the external energy source 1004, respectively. The control signal can be modulated in terms of frequency, phase, or amplitude. This can be done.

[0096] Therefore, the feedback is transmitted by a separate communication system including a receiver and a transmitter. It can also transmit information and be integrated into energy systems. If we consider this integrated information feedback and energy system, a first electronic circuit connected to the first coil; and a second external coil and a second coil. an external energy sensor for transmitting wireless energy, the external energy sensor having a second electronic circuit connected to the coil; The second external coil of the energy transmitter is connected to the first external coil of the energy receiver. The system further comprises: a first coil; a power switch for switching on and off the connection of the first internal coil to the electronic circuitry; A power switch switches on and off the connection of the first internal coil to the first electronic circuit. When the second external coil is connected to the first coil, the voltage of the first coil changes in the form of a change in the impedance of the load of the second external coil. Feedback information regarding the load is received by an external energy transmitter. When the stem is mounted in the mechanism of FIG. 17, the switch 1026 is The switch may be controlled separately from the internal control unit 1015 or may be integrated into the internal control unit 1015. It should be understood that 1026 should be interpreted as the broadest embodiment. Transistor, MCU, MCPU, ASIC, FPGA or DA converter or any other This means that an electronic component or circuit can be powered on and off.

[0097] In conclusion, the energy supply mechanism shown in Figure 22 basically operates as follows: Energy balance is determined initially by the device's internal control unit. The control signal reflecting the required energy amount is also determined by the internal control unit 1015. The control signal is generated by the internal signal transmitter 1027 and transmitted to the external signal receiver 1030. Alternatively, as mentioned above, depending on the implementation, Energy balance can then be determined by the external control unit 1004b. In that case, the control signal may carry measurements from various sensors. Based on the determined energy balance, for example, in response to a received control signal, the body The amount of energy emitted from the external energy source 1004a is transmitted to the external control unit 1004b. This process can be regulated by specific It can be repeated intermittently at intervals and can be performed more or less continuously during energy transfer. It is also possible.

[0098] The amount of energy transferred is generally determined by the voltage, current, amplitude, wave frequency, and pulse By adjusting various transmission parameters of the external energy source 1004a, such as the characteristics of can be adjusted.

[0099] This system is used to find the optimal position of the external coil relative to the internal coil and Finally, the TET system is further calibrated to optimize energy transfer. It is also possible to obtain information about the coupling coefficient between the coils of the system. The amount of energy delivered is compared to the amount of energy received. For example, if the external coil moves, In this case, the coupling coefficient may change, and the movement becomes more accurate as the external coil Preferably, the external coil is positioned so that the coupling coefficient is maximized. The energy transmitted is then adjusted to realize the feedback information of the decision device before it becomes too large. It is adapted to calibrate the amount of

[0100] This coupling coefficient information can also be used as feedback during energy transfer. In such a case, the energy system of the present invention includes a first internal coil and a first a first electronic circuit connected to the coil of the implantable wireless energy receiving device; an internal energy receiver, a second external coil, and a second electronic coil connected to the second coil; and an external energy transmitter having a circuit for transmitting wireless energy. The second external coil of the transmitter transmits a wireless signal that is received by the first coil of the energy receiver. The system further includes a first coil as feedback information. a second electronic circuit having a feedback device that communicates the amount of energy received by the The decision device includes a decision device that receives the feedback information and decides whether to To obtain the coupling coefficient between the coil and the second coil, the energy transferred by the second coil is and comparing the amount of energy received by the first coil with feedback information about the amount of energy received by the first coil. The energy transmitter adjusts the transmitted energy in response to the obtained coupling coefficient. It is possible.

[0101] Referring to FIG. 23, an energy source for operating the device to enable non-invasive operation is shown. Although wireless energy transmission was described above, the device can also operate with wired energy. It will be appreciated that such an example is shown in FIG. 18, where an external switch 102 6 operates in conjunction with an external energy source 1004a, such as an electric motor 1007, which operates the device 10. The external control unit 1004b is interconnected between the operating devices. The operation of the external switch 1026 is controlled so as to perform the desired operation.

[0102] FIG. 24 illustrates how received energy can be provided to and used by device 10. Similar to the example of FIG. 17, the internal energy receiver 1002 is Wireless energy is emitted from an external energy source 1004a controlled by a transmission control unit 1004b. The internal energy receiver 1002 receives the energy E at a constant voltage. 0, which is shown in the dashed box "Constant Voltage V" in the figure. The internal energy receiver 1002 further provides energy to the device 10 at a constant current. A constant current circuit can be provided to supply this, which is shown in the dashed box "Constant Current C" in the figure. show.

[0103] The device 10 comprises an energy consuming portion 10a, which is motors, pumps, restricting devices, or any other device that requires energy for electrical operation The device 10 may be a medical device. The device 10 may further receive energy from the internal energy receiver 1002. An energy storage device 10b may be provided to store energy. The supplied energy may be directly consumed by the energy consuming portion 10a, or may be stored in a form similar to the energy The energy stored in the storage device 10b or supplied is partly consumed. The device 10 further receives energy from the internal energy receiver 1002. An energy stabilization unit 10c may be provided to stabilize the supplied energy. Therefore, energy can be supplied in increasing or decreasing amounts, and thus consumed or Energy needs to be stabilized before storage.

[0104] The energy provided by the internal energy receiver 1002 is further transmitted by the device 10. Separate energy stabilization located outside the device 10 before it is consumed and / or stored The energy may be stored and / or stabilized by unit 1028. A stabilization unit 1028 may be incorporated into the internal energy receiver 1002. In either case, the energy stabilization unit 1028 may include a constant voltage circuit and / or a constant current A circuit may be provided.

[0105] 22 and 24 illustrate how the various functional components and elements shown can be arranged and Some possible, but non-limiting, implementation choices regarding how the devices can be connected to each other are: It should be noted that alternatives are shown, however, many variations and modifications are possible within the scope of the present invention. Those skilled in the art will readily appreciate that this can be done.

[0106] Figure 25 shows a system for controlling wireless energy transmission or energy balance control. The schematic diagram shows one of the proposed designs for the energy balance measurement circuit. The path has an output signal, which is centered around 2.5V and has an energy imbalance. The derivative of such a signal is the difference between whether the value is rising or falling and the change in value. The amount of received energy used by the implanted components of the device. If there is less energy than The output signal from the circuit is typically fed to an A / D converter and converted to a digital signal. The digital information is then transmitted to an external energy transmission device. The level of energy transmitted can be adjusted at the device. The advantage is that you have a completely analog system that uses comparators, The level of energy balance is compared to specific maximum and minimum thresholds, and the imbalance is measured. If the temperature is too high and falls outside the maximum / minimum window, the information is sent to the external energy transmission device. Send.

[0107] Schematic diagram 25 shows the implantation of the device of the present invention from outside the patient's body using inductive energy transfer. 1 illustrates a circuit implementation of a system for transferring energy to an inductive energy component. Sexual energy transfer systems typically use an external transmitting coil and an internal receiving coil. The receiving coil L1 is included in schematic diagram 3, the transmitting portion of the system is not included.

[0108] A general concept of energy balance and how information is transmitted to an external energy transmitter The implementation of can, of course, be implemented in many different ways. Schematic 25 and the method described above are only examples of how a control system may be implemented. It should be interpreted.

[0109] Circuit Details In Figure 25, the symbols Y1, Y2, Y3, etc. symbolize test points within the circuit. The components and their respective values ​​in the diagram are values ​​that function in this particular implementation and are not intended to be limiting. Of course, this is just one of countless possible design solutions.

[0110] The energy that powers the circuit is received by the energy receiving coil L1. The energy to the formula components is transmitted at a frequency of 25 kHz in this particular case. The energy balance output signal is at test point Y1.

[0111] It will be appreciated that the various embodiments of the above system can be combined in many different ways. For example, the electrical switch 1006 of FIG. 8 may be replaced with the electrical switch 1006 of the embodiments of FIGS. The hydraulic valve shift device 1014 of FIG. 11 may be incorporated in either form. 10 embodiment, and the gear box 1024 may be incorporated into the embodiment of FIG. A switch can also simply mean any electronic circuit or component. I want to be recognized that I can do it.

[0112] The embodiments described in connection with Figures 22, 24 and 25 are electrically operable devices. and system for controlling wireless energy transmission to an implanted energy-consuming component of a device - Patents.com Such a method and system is generally defined below.

[0113] Thus, wireless energy supplied to the implanted energy consuming components of the above described devices A method for controlling the transmission of energy is provided. Wireless energy E is delivered to a location outside the patient's body. The energy is transmitted from an external energy source located inside the patient and is received by an internal energy receiver located inside the patient. The energy is received by the internal energy receiver, which transmits the received energy to the implanted energy Connected to an energy consuming component to supply that component directly or indirectly The energy received by the internal energy receiver and the energy used for the device are The energy balance is then determined between the energy received from the external energy source and the energy received from the external energy source. The transmission of wireless energy E is controlled based on the determined energy balance .

[0114] The primary coil of the external energy source is inductively and wirelessly transmitted to the secondary coil of the internal energy receiver. Energy can be transferred. Determine the change in energy balance and The wireless energy transmission can be controlled based on the change in the internal energy balance. The energy received by the energy receiver and the energy used for the medical device The system detects the difference in energy between the receiver and the receiver, and controls the transmission of wireless energy based on the detected energy difference. It can also be controlled.

[0115] When controlling the energy transfer, the detected change in the energy balance is If the energy balance indicates an increase, reduce the amount of wireless energy being transmitted. The decrease / increase in energy transmission can also be detected. The amount of change may correspond to the amount of change.

[0116] If the difference in detected energy indicates that the received energy is greater than the used energy, In this case, the amount of transmitted radio energy can be further reduced, or vice versa. In that case, the decrease / increase in energy transmission is proportional to the difference in the detected energy. The size may be the same.

[0117] As mentioned above, the energy used for the medical device is and / or at least one energy storage device of the medical device. The information can be stored in a storage device.

[0118] The electrical and / or physical parameters of the medical device and / or the patient's physical When a fundamental parameter is determined, the time per unit time determined based on the parameter is Energy can be transmitted for consumption and storage according to the transmission rate. The total amount of energy delivered can also be determined based on the parameters.

[0119] The total amount of energy received by the internal energy receiver and consumed and / or stored The difference between the total amount of energy transferred and the energy balance is detected. when it relates to the time integral of at least one measured electrical parameter of the lance , with respect to the monitored voltage and / or current in relation to the energy balance The integral can be determined.

[0120] Derivative of a measured electrical parameter with respect to the amount of consumed and / or stored energy When determined over a period of time, monitoring related to energy balance The derivative can be determined with respect to the measured voltage and / or current.

[0121] transmitting wireless energy from the first electrical circuit to an external energy source; and falling edges of the electric pulses are applied, and the successive rising and falling edges of the electric pulses are The length of the first time interval between the rising and falling edges of the electrical pulse and / or the successive falling and rising edges of the electrical pulse. By varying the length of the second time interval between the lift-off and the transmission of wireless energy. , can control the transmission of wireless energy from an external energy source, from electrical pulses The resulting transmitted energy has a changed power, and the change in power is determined by the first and / or second Varies depending on the length of the time interval.

[0122] In that case, the frequency of the electrical pulses is varied during the first and / or second time intervals. When applying an electrical pulse, the electrical pulse may be applied at a first and a second time. and / or the second time interval may remain unchanged except for the change in the amplitude of the electrical pulse. The first and / or second time intervals may be substantially constant when varied. The electrical pulse can be varied by simply changing the length of the first time interval between the rising and falling edges. can be changed.

[0123] Two or more electric pulse trains can be delivered in succession, and the pulse trains can be applied and The pulse train has a first electrical pulse at the beginning of the pulse train and a second electrical pulse at the end of the pulse train. When a pulse is provided, two or more pulse trains can be provided in succession, with the first pulse The falling edge of the second electrical pulse in the train and the rising edge of the first electrical pulse in the second pulse train The length of the second time interval between is varied.

[0124] When applying an electric pulse, the electric pulse provides a virtually constant current and a virtually constant voltage. The electrical pulse may also have a virtually constant current and a virtually constant voltage. Additionally, the electrical pulses may have a virtually constant frequency. The electrical pulses may also have a virtually constant frequency.

[0125] The circuit formed by the first electrical circuit and the external energy source is or first time constant, effectively changing the energy being transmitted. Such frequency time periods may be within or shorter than the first characteristic period or time constant. stomach.

[0126] Therefore, a system including a device as described above may also be used to implant energy into the device. It is provided to control the transmission of wireless energy supplied to the consuming components. In a broad sense, the system is a system for transmitting wireless energy from an energy transmission device. a control device for controlling the transmission of wireless energy; and an implantable device for receiving the transmitted wireless energy. The internal energy receiver is capable of transmitting the received energy to the to directly or indirectly supply the implantable energy consuming components of the device. The system is further connected to the energy-consuming components of the body. The energy received by the transmitter and used by the implantable energy-consuming components of the device A determination device adapted to determine the energy balance between the energy used The external control unit is equipped with a chair and determines the energy balance determined by the device. The transmission of wireless energy from the external energy transmission device is controlled based on the received signal.

[0127] Additionally, the system may include any of the following:

[0128] The device is adapted to transmit wireless energy by induction to a secondary coil of an internal energy receiver. The primary coil in an external energy source.

[0129] The determination device is adapted to detect changes in energy balance and is ex vivo The control unit adjusts the wireless energy transmission based on the detected energy balance change. Control the transmission.

[0130] The determination device determines the energy received by the internal energy receiver and the energy received by the implanted device. to detect the difference between the energy used for the energy consuming component and the energy The external control unit is adapted to detect the difference in the energy levels of the wireless energy sources. Controls the transmission of

[0131] The detected change in energy balance indicates an increase in energy balance. When the external control unit detects a condition, the external control unit may configure the external control unit to reduce the amount of transmitted wireless energy. Controlling an external energy transmission device, or vice versa, is possible, reducing energy transmission. / The increase corresponds to the detected rate of change.

[0132] The difference in detected energy means that the received energy is greater than the energy used. If the external control unit determines that the amount of wireless energy being transmitted is too high, the external control unit may reduce the amount of wireless energy being transmitted. It is also possible to control an external energy transmission device to transmit energy to the body, or vice versa. The decrease / increase in energy transfer corresponds to the magnitude of the detected energy difference.

[0133] The energy used for the device is consumed to operate the device and / or is stored in at least one energy storage device of the apparatus.

[0134] The electrical and / or physical parameters of the device and / or the physical parameters of the patient If the parameter is determined, the energy transmission device determines the parameter by the determining device. The energy consumed and stored according to the transmission rate per unit time determined based on the data The determination device determines the total amount of energy to be transmitted based on the parameters. Also determined.

[0135] The total amount of energy received by the internal energy receiver and consumed and / or stored The difference between the total energy input and the energy When it concerns the time integral of at least one measured electrical parameter with respect to the The determination device monitors voltage and / or energy balance Determine the integral with respect to the current.

[0136] Derivation of measured electrical parameters related to the amount of consumed and / or stored energy When a function is determined over a period of time, the determining device determines the energy balance. The derivative with respect to the relevant monitored voltage and / or current is determined.

[0137] The energy transmission device includes a coil placed outside the human body, and the electrical circuit transmits wireless energy. The external coil is provided to be powered with electrical pulses to transfer energy. The energy pulse has a rising edge and a falling edge, and the electrical circuit The first period between successive rising and falling edges of the electrical pulse is Varying the time interval and / or the second time interval between successive falling and rising edges As a result, the energy receiving device is adapted to receive the transmitted wireless energy. The transmitter has a modified power.

[0138] The electrical circuit remains unchanged except for varying the first and / or second time intervals. The device is adapted to deliver electrical pulses up to

[0139] The electrical circuit has a time constant and varies the first and second time intervals only within the range of the first time constant. and adapted to change the length of the first and / or second time intervals. When the voltage is changed, the power transmitted over the coil is changed.

[0140] The electrical circuit measures the first time interval between successive rising and falling edges of the electrical pulses. It is adapted to deliver electrical pulses that are varied simply by varying their length.

[0141] the electrical circuit is adapted to deliver two or more electrical pulse trains in succession; The train has a first electrical pulse at the beginning of the pulse train and a second electrical pulse at the end of the pulse train. It has

[0142] The falling edge of the second electrical pulse of the first pulse train and the falling edge of the first electrical pulse of the second pulse train are consecutive. The length of the second time interval between the rising edges of the electrical pulses is changed by the first electronic circuit. will be done.

[0143] The electric circuit has a substantially constant height and / or amplitude and / or intensity and / or The electrical pulses are supplied as pulses having a voltage and / or current and / or frequency. It is adapted to

[0144] The electrical circuit has a time constant and varies the first and second time intervals only within the range of the first time constant. and adapted to change the length of the first and / or second time intervals. When the voltage is changed, the power transmitted on the first coil is changed.

[0145] The electrical circuit may have a magnitude of the first and / or second time intervals that is greater than or equal to the magnitude of the first time constant. The electrical length is changed only within a range that includes or is relatively close to the first time constant. The pulse is adapted to deliver the pulse.

[0146] 26-29 are more detailed block diagrams showing how hydraulic or This section shows four different ways to power a motor or pneumatically.

[0147] FIG. 26 shows the system described above. The system includes an implantable device 10. , a separate regulation reservoir 1013, a one-way pump 1009, and an alternating valve 1014. Prepare for this.

[0148] Figure 27 shows the device 10 and the fluid reservoir 1013. Moving the walls of the regulation reservoir or by changing its size in any other different way. By simply moving the valve, the device can be adjusted without any fluid flowing through the passage. It is possible.

[0149] FIG. 28 shows the device 10, the two-way pump 1009, and the regulation reservoir 1013.

[0150] FIG. 29 shows a reversing servo with a first closed system controlling a second closed system. The servo system includes a regulating reservoir 1013 and a servo Servo reservoir 1050 is connected to mechanical interconnect 105 The implanted device 10 is mechanically controlled via the oscilloscope 4. The device has an expandable / accessible cavity. The cavity preferably includes a larger, adjustable reservoir in fluid communication with the device 10. The cavity expands or contracts by supplying hydraulic fluid from the valve 1052. It contains a compressible gas that is compressed and expanded under the control of a servo reservoir 1050. It can be stretched.

[0151] The servo reservoir 1050 may also be part of the device itself.

[0152] In one embodiment, the regulation reservoir is placed subcutaneously under the patient's skin and is accessible by a finger. It is operated by pressing on the outer surface. This system is shown in Figures 30a to 30c. In the figure, a flexible subcutaneous regulation reservoir 1013 is connected to a bulge-shaped servo regulator by a conduit 1011. The servo reservoir 1050 is shown connected to the bellows type servo reservoir. The servo reservoir 1050 is included in the flexible device 10. In the state shown in FIG. 1050 contains the least amount of fluid, with most of the fluid being in the regulation reservoir 1013. The mechanical interconnection between the reservoir 1050 and the device 10 reduces the external shape of the device 10. This maximum volume is shown in the figure by a dashed line. vinegar.

[0153] In FIG. 30b, a user, such as a patient having an implanted device, presses the regulation reservoir 1013, The fluid contained therein flows through the conduit 1011 and, due to the bellows shape, 10 shows the state where the servo reservoir 1050 extends in the direction of the arrow. The device 10 is expanded so that it occupies its maximum volume and thereby penetrates the stomach wall (Fig. (not shown) is stretched.

[0154] The regulation reservoir 1013 preferably has means 1013a for maintaining its shape after compression. This means is therefore shown only diagrammatically in the figures and is not intended to be used by the user to insert the adjustment reservoir. The device 10 remains in the extended position when released. In this way, the regulation reservoir , which essentially acts as an on / off switch for the system.

[0155] Next, referring to Figures 31 and 32a-32c, alternatives for hydraulic or pneumatic operation are shown. The block diagram shown in Figure 31 illustrates a first closed system that controls a second closed system. The first system comprises a regulation reservoir 1013 and a servo regulator. The servo reservoir 1050 is connected to the servo motor via a mechanical interconnect 1054. The larger adjustable reservoir 1052 is then mechanically controlled. The implantable device 10 having a tangible cavity may have a larger adjustable catheter fluidly connected to the device 10. A larger adjustable reservoir can be provided by supplying hydraulic fluid from a removable reservoir 1052. It is controlled by server 1052.

[0156] Next, an example of this embodiment will be described with reference to Figures 32a to 32c. The adjustment reservoir is placed subcutaneously under the patient's skin and pressed against its outer surface with a finger. The regulation reservoir 1013 is connected to a bellows-shaped reservoir by a conduit 1011. The first closed system shown in FIG. 1013, 1011, 1050, the servo reservoir 1050 contains the least amount of fluid, Most of the fluid is in the regulation reservoir 1013 .

[0157] Servo reservoir 1050 mechanically connects to a larger adjustable reservoir 1052 The reservoir 1052 is also bellows shaped, but has a diameter similar to that of the servo reservoir. The larger adjustable reservoir 1052 is in fluid communication with the device 10. This is because the user presses the adjustment reservoir 1013, which causes the fluid to flow into the adjustment reservoir. Servo reservoir 1013 to servo bladder actuation reservoir 1050. 50 expansion allows for a larger volume of fluid to be dispensed from the larger adjustable reservoir 1052 In other words, in such an inverted servo mechanism, , the smaller volume of the regulation reservoir is compressed with a larger force, which results in a larger This allows a larger total area to be moved with less force.

[0158] As in the previous embodiment described above with reference to Figures 32a-32c, an adjustment reservoir The bar 1013 preferably comprises means 1013a for maintaining its shape after compression. This means, which is shown diagrammatically in the figure, therefore also allows the device to be operated when the user releases the adjustment reservoir. 10 in an extended position. In this way, the regulation reservoir essentially acts as an on / off switch for the system. [Explanation of symbols]

[0159] 20 expandable member; 30 bladder; 50 control device; 52 control assembly 54 Bladder-operated reservoir; 56 Interconnected devices; 60 Extracorporeal energy feeding device; 70 extracorporeal control unit;

Claims

1. 1. A device for treating urinary retention in a patient by draining urine from a mammal's natural bladder through the mammal's natural urethra, comprising: an expandable member adapted to be implanted inside the patient's natural bladder; an electrical control device adapted to electrically control the volume of said expandable member to empty said natural bladder; an electrically controllable implantable artificial sphincter configured to contract or not contract the patient's natural urethra from outside the natural urethra with the aid of the expandable member, and to not contract the patient's natural urethra when emptying urine from the natural bladder; An apparatus comprising:

2. 10. The apparatus of claim 1, wherein the electrical control device comprises an internal control unit including a subcutaneously placed switch.

3. 3. The apparatus of claim 1 or 2, wherein the electrical control device comprises at least one motor or pump.

4. 4. Apparatus according to any one of claims 1 to 3, wherein the electrical control device comprises an internal control unit operable from outside the patient's body.

5. - said expandable member is hydraulically controlled and comprises a cavity for hydraulic fluid; - said electrical control device comprises an implantable bladder operating reservoir for hydraulic fluid; - The apparatus of any one of claims 1 to 4, wherein the expandable member and the electrical control device are adapted to be hydraulically connected through the wall of the bladder via an interconnection device, the interconnection device comprising an implantable tube for making the hydraulic connection and for transporting hydraulic fluid between a bladder operating reservoir and a cavity.

6. 6. The device of claim 5, wherein the expandable member is adapted to empty under pressure exerted by urine in the bladder upon transporting the hydraulic fluid from the cavity to the bladder operating reservoir.

7. 6. The apparatus of claim 5, wherein the electrical control device comprises an implantable actuation device that transports hydraulic fluid between a cavity and a bladder operating reservoir, the actuation device being capable of transporting hydraulic fluid to the cavity of the expandable member to obtain a urine pressure appropriate for expelling urine.

8. 8. The apparatus of claim 7, wherein the actuation device is capable of delivering hydraulic fluid to the cavity of the expandable member to obtain a urine pressure of at least 50 cm of water to expel urine.

9. The apparatus of claim 7 , wherein the actuation device is a powered pump.

10. The apparatus of any one of claims 7 to 9, wherein the actuation device comprises at least one of: calibration of hydraulic fluid volume or an injection port adapted to actuate the expandable member.

11. An apparatus according to any one of claims 5 to 10, wherein the hydraulic fluid contains a drug that inhibits bacterial growth.

12. 12. The apparatus of any one of claims 1 to 11, further comprising an implantable restriction device adapted to close each of the patient's ureters when draining urine from the bladder.

13. The apparatus of claim 12 , wherein the restriction device is actuatable by hydraulic fluid.

14. 14. The apparatus of claim 1, wherein the electrical control device further comprises an implantable device that electrically stimulates the bladder muscles to contract.

15. 6. The device of claim 5, wherein the expandable member is adapted to be emptied by at least one of: pressure applied to transport hydraulic fluid from a cavity to a bladder operating reservoir; pressure applied to transport hydraulic fluid from a cavity to the bladder operating reservoir by a second connection between the expandable member and the bladder operating reservoir, the second connection being dimensioned such that when open, the pumping volumetric capacity of the pump is significantly greater than the emptying capacity of the second connection; and the expandable member is adapted to be emptied by pressure applied by urine in the bladder to transport hydraulic fluid from a cavity to the bladder operating reservoir by the second connection.

16. An apparatus according to any preceding claim, wherein the electrical control device comprises an internal control unit configured to receive signals from a wireless remote control.

17. 17. Apparatus according to any one of the preceding claims, further comprising an internal energy receiver adapted to be non-invasively and wirelessly energized by an energy transmission device from outside the patient's body.

18. The apparatus according to any one of claims 1 to 17, further comprising a sensor for detecting at least one physical parameter of the patient.

19. The device according to any one of the preceding claims, further comprising a sensor for detecting at least one functional parameter relating to said device.

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