Controlled urinary incontinence treatment

Treatments to control urinary incontinence

[0001] This application is an international application filed on February 8, 2001: a divisional application with the title of invention "treatment for controlling urinary incontinence", international application number "PCT/SE01/00252", and national application number "0180487&1" .

[0002] The present invention relates to a therapeutic apparatus for controlling urinary incontinence, which includes a restraining device that can be implanted in a patient suffering from urinary incontinence to restrain the urethra or bladder, and form a restrained urine in the urethra or bladder. The restraint device is operable to change the restraint condition of the urinary tract.

[0003] Urinary incontinence is a very common problem. Many people benefit from the training of the pelvic floor muscles, but many people have serious problems with urine leakage. Many different solutions have been tried for the problem of urinary incontinence. For example, there is currently a manually operated urinary incontinence treatment device. The device has an artificial hydraulic sphincter device that constrains the urethra. This device is connected to an elastic reservoir implanted in the scrotum or labia majora. The disadvantage of this treatment device is that the degree of hardening of the fibers around the reservoir develops over time, which may cause failure of the pump components. In addition, when the patient needs to urinate, it is also quite complicated to manually squeeze the implanted elastic reservoir in order to pump hydraulic fluid to open the sphincter device. Especially women will get their fingers wet. Sooner or later, the implanted fibers will become a hardened fiber layer, making pumping to the reservoir more difficult. Another disadvantage is that when hydraulic fluid is applied, there is always the risk of fluid leakage from the implanted hydraulic components.

[0004] Among the existing instruments, US Patent No. 5,520,606 discloses a hydraulic instrument that compresses the urethra. In, for example, U.S. Patent No. 4571749 and U.S. Patent No. 422377 disclose liquid-fillable artificial sphincter with a cuff, which surrounds or surrounds the urethra from both sides. US Patent No. 4969474 discloses a hydraulic method that uses the same method to treat urinary incontinence in men and women. The instrument of US Patent No. 4969474 includes a fluid-filled reservoir and a fluid-fillable compression device to compress the urethra without the risk of tissue loss or gangrene. US Patent No. 5562598 discloses an artificial hydraulically operated urethral sphincter, which uses an external magnet to close the urethral cuff.

[0005] An existing mechanical artificial sphincter has been disclosed in US Patent No. 4,619,245. The sphincter includes an artificial control activation component that can be implanted in a convenient place in the patient's body.

[0006] The purpose of the present invention is to provide a new and convenient urinary incontinence treatment device that patients can use at any time after surgery, especially when there are multiple needs during the day, so patients basically always Satisfied or comfortable.

[0007] In order to achieve this purpose, the urinary incontinence treatment device stated at the beginning of this article is used, which is characterized by being equipped with an energy source and equipped with a control device that can be operated outside the patient's body. The control member is implanted in the restraint device. The human body is used to control the energy to release energy and operate the restraint device implanted in the body.

[0008] In this way, the resulting advantage is that the operation of the restraint device is non-invasive. Moreover, the instrument of the present invention provides a simple and effective energy control method for implanted components, and can ensure that the instrument may work reliably for the rest of the patient's life or at least for many years.

[0009] The control device can also be used to control the restraint device. Such a control device may include an internal control unit, preferably, a microprocessor implantable in the patient to control the restraint device. The control device may further include an external control unit outside the patient's body. Among them, the internal control unit can control the restraint device in accordance with the program of the external control unit, for example, control the restraint device, or control the restraint device in accordance with a time program established by an activity schedule adapted to the patient's needs.

[0010] Its greatest advantage is that at any time of the day, the patient can use this control device to adjust the restraint of the urinary tract as long as he wants.

[0011] This kind of external control unit can easily load data to the internal control unit, and its loading mode should only be in accordance with the way authorized to the doctor. When performing special control on the restraint device, the external control unit can control the internal control unit according to the doctor mode authorized only to the doctor. When the restraint device is simply controlled, the external control unit can control the internal control unit according to the patient mode that the patient is allowed to use. Therefore, by using the external control unit according to different modes, the restraint device can have certain functions controlled by the patient and more advanced functions controlled by the doctor. This advanced function is helpful for the flexible postoperative treatment of the patient.

[0012] This control device can control the release of energy energy, for example, intermittently release energy in the form of a series of energy pulses to directly operate the restraint device. According to a suitable embodiment, the control device controls the energy source to release electrical energy, and the instrument also includes an implantable capacitor that converts the released energy into a series of energy pulses. In this case, the term "direct" means on the one hand that the energy is used once it is released by the control device; on the other hand, it means that the released energy is delayed by, for example, an energy stabilizer on the order of a few seconds. Used to operate restraint devices. The released energy may operate the restraint device in a non-artificial, non-magnetic or non-mechanical manner.

[0013] According to a preferred embodiment of the present invention, the instrument includes at least one implantable electrical device, or only a single voltage level protection and a capacitor or energy storage device, wherein the capacitor or The charging and discharging of the energy storage are controlled by this voltage level protection. Therefore, there is no need for any implanted current detector and/or charge level detector to control the capacitor, thus making the instrument simple and reliable.

[0014] Generally, the instrument also includes an operating device implantable in the patient to operate the restraint device, wherein the control device controls the operating device to operate the restraint device. The control device can use the energy released by the energy source to directly power the operating device and/or other energy-consuming implant components of the instrument. In this case, the term "direct" means that once the energy is released by the control device, the energy is immediately supplied to the operating device; on the other hand, it also means that the released energy may be delayed by, for example, an energy stabilizer. After a few seconds, power is supplied to the operating device. The advantage of directly using the newly released energy is that the design of the instrument can be very simple, and it contains only a few parts, so that the instrument works reliably.

[0015] The control device may release magnetic energy, electromagnetic energy, kinetic energy, acoustic energy or thermal energy; or non-magnetic energy, non-acoustic energy, non-thermal energy, non-electromagnetic energy or non-kinetic energy.

[0016] However, the present operating device preferably includes an electric operating device.

[0017] The instrument of the present invention typically includes an adjustment device for adjusting the restriction device to change the restriction of the urinary tract. The adjustment device can be adapted to the mechanical adjustment of the restraint device. Or, it can be adapted to the hydraulic adjustment of the restraint device. The hydraulic medium used does not contain those hydraulic fluids whose viscosity is basically increased in heat or magnetic fields, that is, the hydraulic fluid will not change under the influence of heat or magnetic force. Got more sticky.

[0018] The restraint device may be non-liquid-filled, that is, hydraulic fluid does not participate in the adjustment of the restraint device. In this way, there is no problem of fluid leakage from the restraint device.

[0019] The operating device may include some hydraulic tools, including at least one valve for controlling the flow of fluid in the hydraulic tool. The control device may suitably include a wireless remote control for controlling the valve. The restraining device may include a hydraulic tool, and the operating device may include a liquid reservoir to form a fluid chamber with a variable volume connected to the hydraulic tool. The operating device can deliver fluid from the fluid chamber to the hydraulic tool by reducing the volume of the fluid chamber, or expand the volume of the fluid chamber to draw fluid from the hydraulic tool back into the fluid chamber.

[0020] According to the first main aspect of the present invention, the energy source is located outside the patient's body, and the energy source is controlled by the control device to release wireless energy. This external energy source can be any possible energy source, such as nuclear energy or chemical energy.

[0021] An energy storage device, preferably, an electrical energy storage device can be implanted in the patient's body to store the wireless energy released by the external energy source. Such an electrical energy storage device may include at least one capacitor, or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. Alternatively, a battery can be implanted in the patient's body to provide electrical energy other than wireless energy to the implanted components of the instrument that consume electrical energy. The control device includes an implantable control unit, and the electronic circuit and the restraint device can be directly powered by the converted wireless energy, or by an implantable energy storage device or battery.

[0022] According to the second main aspect of the present invention, this wireless energy is directly used for the operation of the restraint device, that is, the restraint device is operated after the wireless energy is released from the external energy source by the control device. In this case, the term "direct" is used on the one hand to indicate that the released energy is not stored first, but is used to operate the restraint device; on the other hand, it also indicates that the released energy may be, for example, an energy The stabilizer is only used for the operation of the restraint device after a delay of several seconds. In this way, the operation of the restraint device is very simple, and the entire instrument has only a few components implanted. For example, there is neither an implanted energy source such as a battery nor any complex implanted signal control system in the instrument. This makes the instrument extremely reliable. [0023] Generally, the control device uses the wireless energy released by the energy source to control the operating device, and directly or indirectly supplies power to the operating device and/or other energy-consuming components implanted in the instrument.

[0024] According to the first and second main aspects of the present invention, in the first specific embodiment, the operating device includes a motor, preferably an electric motor, the conductive part of which is plastic. The motor includes a rotary motor, wherein a control device is used to control the rotary motor to rotate it to the required number of turns. Alternatively, the motor may comprise a linear motor, or a hydraulic or pneumatic fluid motor, wherein the control device is used to control the flow of fluid through the fluid motor. Motors available on the market today are getting smaller and smaller. In addition, there are many kinds of control methods and miniaturized control equipment available. For example, the number of rotations of a rotating motor can be analyzed with a Hall element with a size of only a few millimeters.

[0025] According to the first and second main aspects of the present invention, in the second specific embodiment, the control device is used to change the polarity of the released energy to reverse the function of the operating device. The operating device may include an appropriate electric motor, and the released energy may include electrical energy.

[0026] According to the first and second main aspects of the present invention, in a third specific embodiment, the restraint device can perform a function reversal operation, a function that a reversing device implantable in the patient can make the restraint device perform reverse. This reversal function preferably involves the restriction device to either dilate or restrict the urinary tract, and it is most suitable to use stepless changes. For this reason, the reversing device, which may include a switch, is appropriately controlled by the control device to reverse the function performed by the restraint device. The reversing device may include a hydraulic tool that contains a valve that changes the direction of fluid flow in the hydraulic tool. Alternatively, the reversing device may include a mechanical reversing device, such as a switch or a gear box.

[0027] When the reversing device includes a switch, the control device controls the operation of the switch by switching the polarity of the energy released by the supply switch. Such a switch may include an electric switch whose operation can be powered by an energy source. The aforementioned switch may comprise an electric switch or, if appropriate, a mechanical switch.

[0028] According to a third specific embodiment, the operating device preferably includes a motor, wherein the reversing device reverses the motor.

[0029] According to the first and second main aspects of the present invention, in the fourth specific embodiment, the restriction device includes a hydraulic tool, for example, a cavity capable of holding fluid that can be expanded/reduced. Preferably, the operating device is equipped so that it can conduct the hydraulic fluid in the hydraulic tool. The operating device includes a motor, a valveless fluid conduit connected to the hydraulic tool of the restraint device, and a liquid storage tank, wherein The reservoir is part of the conduit. The operating device includes a suitable motor-operated pump. All hydraulic components included preferably avoid any irreversible valves. such

It has great advantages, because the working valve is not suitable, especially when the time interval between two operations of the valve is very long, the use of this kind of valve will fail. The reservoir can be in the form of a fluid chamber with a variable volume. The pump can transport fluid from the fluid chamber to the hydraulic tool by reducing the volume of the fluid chamber, or expand the volume of the fluid chamber to pump fluid from the hydraulic tool back to the fluid chamber in.

[0030] According to the third main aspect of the present invention, the energy source is implanted in the patient. When the energy source is implanted in the patient's body, the control device controls the energy source to release energy from the patient's body. This solution is very beneficial to the implementation of the instrument that consumes relatively more energy in the various implementations of the instrument, because these implementations can not meet the demand by directly using wireless energy for energy.

[0031] The implanted energy source may include an energy storage, preferably an electrical energy source, such as a battery with a lifespan of at least 10 years.

[0032] According to the fourth main aspect of the present invention, the instrument includes a switch implanted in the patient's body to directly or indirectly turn on or off the restraint device; the instrument also includes a built-in energy source such as a battery. It is implanted in the patient to provide energy for the operation of the restraint device. At this time, the switch directly or indirectly affects the use of built-in energy. This solution is very beneficial to the implementations that consume relatively more energy in the various implementations of the instrument, because these implementations can not meet the demand by directly using wireless energy to supply energy.

[0033] According to the fourth main aspect of the present invention, in the first specific embodiment, the switch is switched between two modes of off and on. In the off mode, the built-in energy source is in a non-working state and in the on mode. When the time, the built-in energy source provides energy for the operation of the restraint device. In this case, the wireless energy released by the external energy source can be used to conveniently operate the switch to switch between on and off modes. Preferably, it includes a control device of a wireless remote control, which can control an external energy source to release wireless energy. The advantage of this embodiment is that the life of the implanted energy source, such as a battery, can be significantly extended, because the implanted energy source does not supply energy when the switch is in the off mode.

[0034] According to the fourth main aspect of the present invention, in the second specific embodiment, the control device includes a wireless remote control for controlling the built-in energy source. In this case, the switch is operated by the wireless energy of an external energy source, making it switch between on and standby mode. In the off mode, the built-in energy source and the remote control are both in a non-working state; in the standby mode, the remote control is allowed to control the built-in energy source to provide energy for the operation of the restraint device.

[0035] According to the fourth main aspect of the present invention, in the third specific implementation, the instrument also includes an energy conversion device implanted in the patient to convert wireless energy into storable energy, wherein the built-in energy can be Store this storable energy. The built-in energy source preferably includes an electric energy storage, at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. In this case, the switch switches between off and on mode. In the off mode, the built-in energy source is in a non-working state; in the on mode, the built-in energy source provides energy for the operation of the restraint device.

[0036] Preferably, a control device including a wireless remote control can control the switch to switch between two modes of on and off.

[0037] Alternatively, in a third specific embodiment, in order to replace the built-in energy source, an energy storage device can be implanted in the patient to store storable energy, wherein the energy of the implanted energy storage device is used to operate the switch, Make it switch between off and on mode. When in off mode, the built-in energy source is in a non-working state; when in on mode, the built-in energy source provides energy for the operation of the restraint device. In this case, in order to operate the switch, the energy storage device is controlled by the control device (wireless remote control).

[0038] The built-in energy source preferably includes an electric energy source, such as an energy storage device, or a battery with a lifespan of at least 10 years. However, other types of energy sources, such as nuclear energy or chemical energy, can also be used.

[0039] The first, second, third, and fourth specific implementations of the first and second main aspects of the present invention are described above.

The implementation scheme is also applicable to the third main aspect of the present invention, that is, when the energy source is implantable, and also applicable to the fourth main aspect of the present invention, that is, when the instrument includes an implantable switch.

[0040] All the above embodiments can be combined with at least one implantable sensor, so as to sense at least one physical parameter of the patient, wherein the control device can control the restraint device according to the signal of the sensor. For example, the sensor may include a pressure sensor that directly or indirectly senses the pressure in the urethra or bladder. The term "indirect sensing of the pressure in the urethra or bladder" should be understood as: the pressure at the position of the restraint device or the patient's body tissue sensed by the sensor. When the control device includes an internal control unit implanted in the patient's body, the internal control unit can appropriately directly control the restraint device according to the signal of the sensor. For example, according to the pressure sent by the sensor, the patient's posture or any other important physical parameters and other signals, the internal control unit can immediately send relevant information to the patient's body. The control unit can also automatically control the restraint device according to the signal of the sensor. For example, when the sensor senses that the patient is lying down, the control unit can control the restraint device to make it steadily approach the urinary tract; or when the sensor senses that abnormally high pressure is applied to the restraint device, the control unit can Urinary tract dilation.

[0041] When the control unit includes an external control unit located outside the patient's body, the external control unit can appropriately directly control the restraint device according to the signal of the sensor. The external control unit can store information about body parameters sensed by the sensor, and perform manual operations based on the stored information to control the restraint device. In addition, there must be at least one implantable transmitter to transmit the body parameters sensed by the sensor.

[0042] An external data communication device may be equipped outside the patient's body. In order to exchange information with the external data communication device, an internal data communication device may be implanted in the patient's body. The internal data communication device can feed back the data about the patient or the data about the restraint device to the external data communication device. Or vice versa, or in a combination, the external data communication device can feed data to the internal data communication device. The internal data communication device can appropriately provide at least one data about the patient's body signal.

[0043] Generally, the instrument of the present invention may include a switch that can be implanted in the patient's body to directly or indirectly turn on or turn off the energy released by the energy source. For example, the restriction device can be operated to turn on and off the urinary tract, or the restriction of the urinary tract can be steplessly controlled. A pressure sensor can be installed to directly or indirectly sense the pressure in the urethra or bladder. The control device controls the restraint device according to the signal of the pressure sensor.

[0044] The instrument may include an implantable energy conversion device, the control device releases electrical energy, and the energy conversion device converts the electrical energy into kinetic energy, preferably directly using the kinetic energy to operate the restraint device. Correspondingly, an implantable stabilizer, such as a capacitor or a rechargeable energy storage device, or similar components, can be used to stabilize the electrical energy released by the control device. In addition, the control device can control the released energy within a set time interval or within a set number of energy pulses. Finally, the restraint device may not be liquid-filled.

[0045] All the above embodiments preferably implement remote control. It is advantageous for the control device to include a wireless remote control, which can transmit at least one wireless signal to control the restraint device. With such a remote control, it is possible to match the functions of the instrument with the basic daily needs of the patient, which is beneficial to the treatment of the patient.

[0046] The wireless remote controller can obtain information about the condition of the restraint device, and control the restraint device according to the information about the control situation. Furthermore, the remote controller can send information about the restraint device from the patient's body to the outside of the patient's body. [0047] In a specific embodiment of the present invention, the wireless remote control includes at least an external signal transmitter or a transceiver and at least an internal signal receiver or transceiver that can be implanted in the patient. In another specific embodiment of the present invention, the wireless remote control includes at least an external signal receiver or a transceiver and at least an internal signal transmitter or transceiver that can be implanted in the patient.

[0048] The remote control transmits a carrier signal to transmit a control signal, where the carrier signal is frequency modulation, amplitude modulation, or both frequency and amplitude modulation, and is digital, analog, or digital and analog. The control signal using the carrier signal can also be frequency modulation, amplitude modulation, or both frequency and amplitude modulation.

[0049] The control signal may include a wave signal, for example, a sound wave, such as an ultrasonic signal, an electromagnetic wave signal, such as an infrared light signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, X -Ray radiation signal or gamma radiation signal, it is also possible to combine two or more of the above-mentioned signals for application.

[0050] The control signal may be digital or analog, and may include an electric field or a magnetic field. Correspondingly, the wireless remote control can transmit an electromagnetic carrier signal to transmit digital or analog control signals. For example, the use of analog carrier signals to transmit digital control signals will make communications secure. The control signal can be transmitted in pulse form with a wireless remote control.

[0051] In all the above solutions, it is convenient for the control device to release energy from the energy source in any of the following ways: non-invasive, magnetic, non-magnetic, mechanical or non-mechanical.

[0052] The control device may release magnetic energy, electromagnetic energy, kinetic energy, or thermal energy, or release non-magnetic, non-thermal, non-electromagnetic, or non-kinetic energy.

[0053] The control device can be activated manually or non-manually to control the energy source to release energy.

[0054] The above-stated embodiments of the present invention can be modified in accordance with the following comments. The released energy can include electrical energy, and an implantable capacitor with a capacitance of less than 0.1 μF can be used to generate the above-mentioned series of energy pulses.

[0055] An implantable motor or pump can be used to operate the restraint device, and a control device can be deployed to control energy, and the released energy can be used to directly provide energy to the motor or pump. Under certain circumstances, the control device can be adjusted so that the wireless energy is released in the form of a magnetic field or electromagnetic waves (except radio waves), and once released, it directly supplies energy to the motor or pump. When using a pump, a non-cylinder plunger type pump is preferred.

[0056] Generally, wireless energy includes a signal.

[0057] The instrument may further include an implantable energy conversion device that directly or indirectly converts wireless energy into energy different from wireless energy to operate the restraint device. For example, the energy converted in this form can be used to power a motor or pump.

[0058] The energy conversion device can convert wireless energy into energy in the form of sound waves, but it is preferably directly converted into electrical energy for operating the restraint device. The energy conversion device may include a capacitor that can be configured to generate electrical pulses from the converted electrical energy.

[0059] The motor mentioned in this description can also be directly powered by electromagnetic energy or magnetic energy emitted wirelessly, and this energy is sent out in the form of a signal. In addition, all the different functions of the motor and the related components described in this description can be applied when applicable.

[0060] Generally, it is advantageous to embed the restraint device in a soft or gel-like material, such as a silicon organic compound material with a hardness of less than 20 Shore hardness.

[0061] Of course, the restraint device is preferably adjusted in a non-manual manner.

[0062] All the above-mentioned different components, such as motors, pumps and capacitors, can be combined in different implementations using different applications. The various functions described above in relation to the various embodiments of the present invention can also be applied in different applications.

[0063] All the different methods of transferring energy and controlling energy stated in this description can be practiced using all the different components and the described solutions.

[0064] The present invention also provides some treatment methods for patients with urinary incontinence.

[0065] Thus, according to the first alternative method, a treatment method is provided for patients suffering from urinary incontinence, which

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The method includes the steps of implanting an operable restraint device in the patient's body, which restrains the urethra or bladder, and forms a restrained urinary tract in the urethra or bladder; configures an energy source to energize the restraint device , Control the energy to release the energy to operate the restraint device. The method may also include using the energy released from the energy source to operate the restraint device to connect and close the urinary tract respectively.

[0066] According to the second alternative method, a treatment method is provided for patients suffering from urinary incontinence. The method includes the steps of placing at least two abdominal anatomical trocars in the patient's body; Insert an anatomical tool and locally dissect the urethra or bladder; place an operable restraint device in the anatomical area, make the restraint device restrain the urethra or bladder, and form a restrained urinary tract in the urethra or bladder; implant energy in the patient's body, And control the implanted energy source from outside the patient's body to release the energy to operate the restraint device.

[0067] According to a third alternative method, a treatment method is provided to a patient suffering from urinary incontinence. The method includes: (a) surgically implanting an operable restraint device in the patient's body, the restraint device Constrain the urethra or bladder to form a constrained urinary tract in the urethra or bladder. (B) Equipping energy sources outside the patient's body. (C) Control the external energy source outside the patient's body to release wireless energy. (D) Use the released wireless energy to operate the restraint device.

[0068] This method may further include (e) implanting an operating device capable of adjusting and constraining the urinary tract according to the provided energy in the human or animal body. And (f) Use the released wireless energy to activate the operating device to (i) restrict the dilation of the urinary tract and allow the urine to flow out smoothly. However, the urinary tract is usually restricted. This method (f) should be implemented at least once a day, usually several times a day (such as 2-10 times).

[0069] According to the fourth alternative method, a treatment method is provided for patients suffering from urinary incontinence. The method includes the steps of placing at least two abdominal anatomical trocars in the patient's body; Insert an anatomical tool and locally dissect the urethra or bladder; place an operable restraint device in the anatomical area so that the restraint device restrains the urethra or bladder to form a restrained urinary tract in the urethra or bladder; equip the patient with energy sources outside; The patient controls the external energy source to release wireless energy outside the body; and uses the released wireless energy to operate the restraint device.

[0070] According to the fifth alternative method, a treatment method is provided for patients suffering from urinary incontinence. The method includes the steps of placing at least two abdominal anatomical trocars in the patient's body; Insert an anatomical tool and locally dissect the urethra or bladder; implant an operable restraint device in the anatomical area so that the restraint device restrains the urethra or bladder to form a restrained urinary tract in the urethra or bladder; implant an energy conversion device; Equipped with external energy; control the external energy to release energy, and convert this wireless energy into energy different from wireless energy, which is used to operate the restraint device. This method may include implanting a stabilizer in the patient to stabilize the energy converted by the energy conversion device.

[0071] The present invention will be described in more detail below with reference to the accompanying drawings. among them

[0072] FIGS. 1 to 6 are block diagrams illustrating six embodiments of the present invention, in which wireless energy released by an external energy source is used to directly operate a restraining device that restrains the patient's urethra or bladder;

[0073] FIGS. 7 to 10 are block diagrams illustrating four embodiments of the present invention, in which energy is released by an implanted energy source;

[0074] FIGS. 11 to 15 are block diagrams illustrating five embodiments of the present invention, in which a switch is implanted in the patient's body to directly or indirectly turn on and turn off the restraint device;

[0075] FIG. 16 illustrates possible combinations of implant components for selection in various communication methods;

[0076] FIG. 17 illustrates the therapeutic apparatus implanted in the patient's body of the present invention;

[0077] FIG. 18 is a block diagram illustrating a remote control part of an embodiment of the present invention; and

[0078] FIG. 19 is an example circuit block diagram used by the components in the block diagram of FIG. 18.

[0079] In the above-mentioned reference figures, the same reference numerals represent equivalent or corresponding elements in several figures.

[0080] FIG. 1 generally shows an embodiment of the urinary incontinence treatment device of the present invention. Some parts of the device are implanted in the patient's body and the other parts are outside the patient's body. All the parts on the right side of the patient's skin 2 in Figure 1 are implanted parts, and all the parts on the left side of the skin 2 are outside the patient's body. The apparatus in Figure 1 includes an operable restraint device 4 implanted in the body to restrain the patient's urethra (or bladder) to form a restrained urinary tract. The restraint device 4 can perform a reversal function, that is, it can turn the urinary tract on and off. An implantation control unit 6 controls the restraint device 4 through a control line 8 to form an appropriate restraint on the urinary tract. The external control unit 10 includes an external energy source and a wireless remote controller, and the wireless remote controller is used to send a control signal generated by the external energy source. This control signal is received by the signal receiver of the implanted control unit 6, and the control unit 6 controls the implanted restraint device 4 according to this control signal. The implanted control unit 6 also uses the energy of this control signal to operate the restraint device 4 through the power cord 12.

[0081] FIG. 2 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 1, except that a reversing device for the reverse operation of the restraint device is implanted in the patient's body, the reversing device It has a switch type 14 and is controlled by energy. The control unit 6 uses the switch 14 to reverse the function performed by the restraint device 4. More precisely, the external control unit 10 releases the energy carried by the wireless signal, and the implanted control unit 6 converts the wireless energy into electric current to operate the switch 14. When the control unit 6 changes the polarity of the current, the switch 14 reverses the function performed by the restraint device 4.

[0082] FIG. 3 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 1, except that an operating device in the form of a motor 16 is also implanted in the patient. The implanted control unit 6 uses the wireless energy released by the external energy source of the external control unit 10 to supply power to the motor 16. The implanted control unit 6 controls the operation of the motor 16 according to the control signal sent by the remote control of the external control unit 10.

[0083] FIG. 4 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 1, except that a component 16 is also implanted in the patient's body, which includes a motor/pump 18 and a Kind of reservoir 20. In this case, the restraint device 4 is operated hydraulically, that is, the hydraulic fluid is pumped from the reservoir 20 to the restraint device 4 through the conduit 22 by the motor/pump unit 18 to restrain the urinary tract, and the hydraulic fluid is also supplied by the motor/pump unit. 18 Pump from the restraint device 4 back to the reservoir 20 to expand the urinary tract. The energy released by the external control unit 10 is carried by wireless signals, and the implanted control unit 6 converts the wireless energy into electric current, for example, into electric current that supplies power to the motor/pump unit 18 through the power cord 24. The implantation control unit 6 controls the motor/pump unit 16 and the restraint device 4 through the control lines 26 and 27.

[0084] FIG. 5 shows an embodiment of the present invention, including a hydraulically operated restraint device 4 and an implanted control unit 6 as well as a hydraulic reservoir 230, a motor/pump unit 232 and a hydraulic valve reversing The device 234 acts as a reversing device, all of which are implanted in the patient's body. The motor of the motor/pump unit 232 is an electric motor.

[0085] FIG. 6 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 1, except that an energy storage device 28 is also implanted in the patient. The control unit 6 receives the energy emitted by the external control unit 10 and stores the energy in the energy storage 28. According to the control signal received from the external control unit 10, the implanted control unit 6 releases energy from the energy storage 28 through the power cord 30 to operate the restraint device 4.

[0086] FIG. 7 shows an embodiment of the present invention, which includes a hydraulically operated restraint device 4 and an implanted control unit 6, as well as an energy source 32 in the form of a battery, a hydraulic fluid reservoir 34, a motor/pump The unit 36 and a kind of reversing device, which is served by the hydraulic valve reversing device 38, are all implanted in the patient's body. The motor of the motor/pump unit 36 is an electric motor. The external control unit 40 includes a wireless remote controller that transmits a control signal, and this control signal is received by a signal receiver embedded in the control unit 6.

[0087] According to the control signal sent by the external control unit 40, the implanted control unit 6 uses the energy of the battery 32 to start the motor/

CN 1698552 Β

The pump unit 36, whereby the motor/pump unit 36 can distribute hydraulic fluid between the reservoir 34 and the restraint device 4. The control unit 6 controls the reversing device 38 to switch the flow direction of the hydraulic fluid between two directions: one direction is that the fluid is pumped by the motor/pump unit 36 from the reservoir 34 to the restraining device 4 to restrain the urinary tract, and the other One direction is the opposite, that is, fluid is pumped by the motor/pump unit 36 from the restraint device 4 back to the reservoir 34 to expand the urinary tract.

[0088] FIG. 8 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 6, except that the battery 42 is used to replace the energy storage 28, and the external control unit 40 of the embodiment of FIG. 5 is used to replace the external control. Unit 10, and an electric motor 44 is implanted in the patient's body to operate the restraint device 4. According to the control signal sent by the external control unit 40, the implanted control unit 6 uses the energy of the battery 42 to supply power to the motor 44, so that the motor 44 operates the restraint device 4.

[0089] FIG. 9 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 8, except that the motor/pump unit 36 of the embodiment of FIG. 7 is used instead of the motor 44, and the fluid reservoir 46 It is also implanted in the patient. The liquid storage tank 46 is connected to the motor/pump unit 36 and the restraint device 4 through the pipes 48 and 50. In this case, the restraint device 4 is hydraulically operated. According to the control signal sent from the external control unit 40, the implanted control unit 6 uses the energy of the battery 42 to supply power to the electric motor of the motor/pump unit 36, so that the motor/pump unit 36 transfers the hydraulic fluid in the fluid reservoir 46 and restrains Distribution between devices 4.

[0090] FIG. 10 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 8, except that a mechanical reversing device 52 in the form of a gear box is also implanted in the patient's body. The implant control unit 6 controls the gear box 52 to reverse the function performed by the restraint device 4 (mechanical operation mode).

[0091] FIG. 11 shows an embodiment of the present invention, which includes a restraint device 4, an external control unit 10, an implanted energy source 236 and an implanted switch 238. The switch 238 is controlled by the wireless energy released by the external energy source of the external control unit 6, and switches between the two modes of off and on. When it is off, the implanted energy 236 is in a non-working state; when it is turned on, the implanted energy is used The energy source 236 provides energy for operating the restraint device 4.

[0092] FIG. 12 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 11. The difference is that the control unit 6 is also implanted in the patient to receive the wireless remote control of the external control unit 10. control signal. The switch 238 is operated by the wireless energy of the external energy source 10 to switch between off and standby modes. In the off mode, the implanted energy source 236 and the wireless remote control of the external control unit 10 are both in a non-working state, that is, control The unit 6 cannot receive control signals; in the standby mode, a wireless remote controller is allowed to control the built-in energy source 236 through the internal control unit 6 to provide energy for operating the restraint device 4.

[0093] FIG. 13 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 12, except that an energy conversion device and an implanted control unit 6 are integrated into one body. The energy conversion device can The wireless energy is converted into storable energy, and the implanted energy source 236 has the ability to store the storable energy. In this case, in accordance with the control signal of the external control unit 10, the implanted control unit 6 switches the switch 238 from the off mode to the on mode. In the off mode, the implanted energy 236 is in a non-working state, and in the on mode , The energy source 36 provides energy for the operation of the restraint device 4.

[0094] FIG. 14 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 13, except that an energy storage device 240 is also implanted in the patient's body, which is used to store the controlled unit 6 The conversion device converts wireless energy into storable energy. In this case, the implanted control unit 6 controls the energy storage device 240 to switch the switch 238 between the off mode and the on mode. In the off mode, the implanted energy 236 is in a non-working state, and in the on mode, the plant The input energy source 236 provides energy for the operation of the restraint device 4.

[0095] FIG. 15 shows an embodiment of the present invention, which is equivalent to the embodiment shown in FIG. 13, except that a motor 242 and a mechanical reversing device 244 in the form of a gear box are also implanted in the patient's body. Implantation control unit 6 control

CN 1698552 Β

The gear box 244 reverses the function performed by the restraint device 4 (mechanical operation mode), that is, expands or restrains the urinary tract.

[0096] FIG. 16 schematically shows the possible combinations between the implanted components of the instrument in order to obtain different information transmission methods. Basically, there are an implanted restraint device 4, an implanted control unit 6, and an external control unit 10 including an external energy source and a wireless remote control. As described above, the remote control sends a control signal generated by an external energy source, and the control signal is received by the signal receiver implanted in the control unit 6. Therefore, the control unit 6 controls the implanted restraint device 4 according to this control signal.

[0097] A sensor 54 can be implanted in the patient to understand the patient's physical parameters, such as parameters such as intragastric pressure. The control unit 6 or the external control unit 10, whichever of the two can control the restraint device 4 according to the signal of the sensor 54. A transceiver and the sensor 54 can be combined into one body, so as to send the information of the sensed body parameter to the external control unit 10. The wireless remote controller of the external control unit 10 may include a signal transmitter or a transceiver, and the implanted control unit 6 may include a signal receiver or a transceiver. Alternatively, the wireless remote control of the external control unit 10 may include a signal receiver or a transceiver, and the implanted control unit 6 may include a signal transmitter or a transceiver. The above-mentioned transceivers, signal transmitters and signal receivers can be used to transmit information or data related to the restraint device from the patient's body to the outside of the patient's body.

[0098] In order to operate the restraint device 4, the motor 44 may be implanted, and to supply power to the motor 44, the battery 32 may also be implanted. The battery 32 may be equipped with a transceiver to send information on the charge status of the battery.

[0099] Those skilled in the art can use many different ways to combine the various embodiments shown in FIGS. 1-15. For example, the energy-operated switch 14 can be combined with any of the embodiments in FIGS. 4, 6, 8-10. The hydraulic reversing device 38 can be combined with any of the embodiments shown in FIGS. 4 and 9. The gear box 52 can be combined with any of the embodiments shown in FIGS. 1, 6, and 8.

[0100] FIG. 17 illustrates how the device of the present invention is implanted in a patient in any of the above embodiments. The figure shows that a combination of the instrument implanted in the patient's body includes a restraint device 56 for restraining the urethra 58, an operating device 60 for operating the restraint device 56, and an internal control unit 62. The internal control unit 62 includes a signal receiver for controlling the operating device 61 . The external control unit 64 includes a signal transmitter that transmits wireless control signals to the signal receiver embedded in the control unit 62. The implanted control unit 62 can convert the signal energy of the control signal into electrical energy, and supply this energy to the operating device 60, and power the energy-consuming components implanted in the instrument.

[0101] FIG. 18 shows the basic part of the wireless remote control of the instrument of the present invention. The basic part includes an electric motor 128 for operating the restraint device, which may have, for example, the type depicted in FIG. 17. In this case, the remote control basically emits a high-frequency electromagnetic wave signal usually on the order of 100kHz-lgHz, which propagates through the patient's skin 130 for remote control. In FIG. 18, all the parts on the left side of the skin 130 are outside the patient's body, and all the parts on the right side of the skin 130 are implanted. Any suitable remote control system can be used.

[0102] The external signal transmitting antenna will be located close to the receiving antenna 134, and the receiving antenna 134 should be implanted close to the skin 130. As an option, the receiving antenna 134 can also be placed inside the patient's body, such as the abdomen. The receiving antenna 134 includes a coil whose diameter is approximately l-100 mm, but preferably 25 mm. The coil is wound with a very thin wire and tuned to a specific high frequency by means of a capacitor. If the coil is to be implanted under the patient's skin, a small coil should be used; if it is to be implanted in the patient's abdomen, a large coil should be used. The transmitting antenna 132 includes a coil, and its requirements are similar to those of the receiving antenna 134, but it needs to be wound with a thick wire in order to handle the large current required. The coil of the transmitting antenna 132 is tuned to the same specific high frequency as the receiving antenna 134.

[0103] The external control unit 136 includes a microprocessor, a high-frequency electromagnetic wave signal generator, and a power amplifier

Device. The microprocessor of the control unit 136 is used to switch the on/off state of the signal generator, and to modulate the signal generated by the generator so as to send digital information to the implant control unit 138 through the power amplifier and antennas 132 and 134. In order to avoid occasional random high-frequency field triggering control commands, digital signal codes are used. An ordinary keyboard located in the external control unit 136 is connected to its microprocessor. The keyboard is used to send commands to the microprocessor and send out digital signals to activate the restraint device, so that the urinary tract may be restrained or expanded. The microprocessor uses the high frequency signal on the antenna 132 to initiate a command. After a short period of time, when the implanted part of the control system obtains energy from the signal, it will issue commands according to pre-designated steps to restrict or dilate the urinary tract. Commands are issued in digital packets, as shown in the following table.

[0104]

<td>Startup diagram,</td><td>command,</td><td>count,</td><td>Checksum,</td>

<td>8-bit</td><td>8-bit</td><td>8-bit</td><td>8-bit</td>

[0105] The command is issued continuously for a considerable period of time (for example, about 30 seconds or longer). When a new constraint or expansion step is requested, the calculation byte is increased by one bit so that the implanted control unit 138 can decode and can infer that the external control unit 136 will require the next step. If an error occurs in any part of the digital packet, its content will be ignored.

[0106] The exciter unit 126 is implanted through the wire 140 to extract energy from the high-frequency electromagnetic wave signal received by the receiving antenna 134. The exciter unit 126 stores energy in a power source, such as a large capacitor, and supplies power to the control unit 138, and supplies power to the electric motor 128 through a line 142.

[0107] The control unit 138 includes a demodulator and a microprocessor. The demodulator demodulates the digital signal sent from the external control unit 136. The microprocessor of the control unit 138 receives the digital packet and decodes it. As long as the energy stored in the power supply of the exciter unit 126 is sufficient, the microprocessor will send a signal to the motor 128 through the signal line 144 according to the received command code to make the restriction The device is restricted or expanded.

[0108] Another approach is that the energy stored in the power supply of the exciter unit is only used to power the switch, and the power to power the motor 128 can be obtained from other relatively large-capacity implanted energy sources, such as batteries. In this case, when the switch obtains energy from the energy source, the battery is connected to the control unit 138, so that the switch is in the ON mode. When the switch does not obtain energy from the energy source, the The connection between the battery and the control unit is disconnected, and the switch remains in standby mode.

[0109] For the remote controller briefly described above, its implementation will now be described in more detail with reference to FIG. 19. The external control unit 136 includes a microprocessor 146, a signal generator 148, and a power amplifier 150 connected to them. The microprocessor 146 is used to switch the on/off state of the signal generator 148, and modulate the signal generated by the signal generator 148 with digital commands, and the modulated signal will be sent to the implanted part of the instrument. The power amplifier 150 amplifies these signals and sends them to the external signal transmitting antenna 132. The antenna 132 and the capacitor 152 are connected in parallel to form a resonance circuit whose frequency is tuned to the frequency generated by the signal generator 148.

[0110] The implanted signal receiving antenna coil 134 and the capacitor 154 form a resonance loop, the frequency of which is tuned to be the same as that of the transmitting antenna 132. The signal receiving antenna 134 generates an induced current after receiving the high-frequency electromagnetic wave, and the rectifier diode 160 rectifies the induced current to charge the energy storage capacitor 158. The coil 156 is connected between the antenna 134 and the diode 160 so that the capacitor 158 and the diode 160 do not load the loop of the signal receiving antenna 134 at high frequencies. Thus, the coil 156 can charge the capacitor 158 and send out digital information in an amplitude modulation manner.

[0111] The capacitor 162 and the resistor 164 are connected in parallel, and the diode 166 forms a detector for detecting vibration and amplitude modulation digital information. The filter circuit is formed by a resistor 168 and a capacitor 174, wherein the resistor 168 and the resistor 170 are connected in series, and the resistor 170 and

CN 1698552 Β

The capacitor 172 is connected in series, and the capacitor 172 and the grounding resistor 168 are connected in series; one end of the capacitor 174 is connected between the resistors 168 and 170, and the other end is connected between the diode 166 and the loop formed by the capacitor 162 and the resistor 164. The filter circuit is used to filter unwanted low frequency and high frequency. The detected and filtered signals are fed into an implanted microprocessor 176, which decodes the digital information and controls the motor 128 through an H-bridge 178 including transistors 180, 182, 184, and 186 . The motor 128 can be driven by the H-bridge 178 in two opposite directions.

[0112] The microprocessor 176 also monitors the amount of energy stored in the energy storage capacitor 158. Before sending a signal to start the motor 128, the microprocessor 176 checks whether the energy stored in the energy storage capacitor 158 is sufficient. If the stored energy is not enough to perform the requested operation, the microprocessor 176 will wait for a signal to be received to charge the energy storage capacitor 158 before starting the motor 128.

CN 1698552 Β