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WO2021098818A1 - 尿道阻断器、尿失禁自动控制系统及其体内机 - Google Patents

尿道阻断器、尿失禁自动控制系统及其体内机 Download PDF

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Publication number
WO2021098818A1
WO2021098818A1 PCT/CN2020/130362 CN2020130362W WO2021098818A1 WO 2021098818 A1 WO2021098818 A1 WO 2021098818A1 CN 2020130362 W CN2020130362 W CN 2020130362W WO 2021098818 A1 WO2021098818 A1 WO 2021098818A1
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WO
WIPO (PCT)
Prior art keywords
urethral
section
support ring
blocker
urethra
Prior art date
Application number
PCT/CN2020/130362
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English (en)
French (fr)
Inventor
吴双宸
Original Assignee
北京泌康医疗科技有限公司
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Publication date
Application filed by 北京泌康医疗科技有限公司 filed Critical 北京泌康医疗科技有限公司
Publication of WO2021098818A1 publication Critical patent/WO2021098818A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable inflatable

Definitions

  • the present disclosure relates to a urethral blocker.
  • the present disclosure also relates to an internal machine for controlling urinary incontinence including the urethral blocker and an automatic urinary incontinence control system including the internal machine.
  • Urinary incontinence is more common in the elderly, and there are some treatment methods. However, there are still a large number of patients who do not have effective treatment methods. They can only rely on continuous catheterization or palliative measures such as changing pads and diapers, which leads to a serious decline in the quality of life of patients. At the same time, it also brings great distress to the patient's family. Therefore, there is a clinical need to develop new urinary incontinence treatment devices.
  • An artificial urethral sphincter device has been developed clinically. Its advantage is that it can not only restore the control of urination, but also urinate through the normal urethra, without affecting the anatomical structure of the sphincter and nearby tissues, and the patient can obtain a better quality of life.
  • the existing artificial urethral sphincter devices also have some shortcomings.
  • the existing artificial urethral sphincter device has low reliability, for example, under certain circumstances, it may excessively compress the urethral tissue, thereby causing damage to the urethral tissue.
  • one of the objectives of the present disclosure is to provide a urethral obstruction device that includes a C-shaped sac and a support ring located outside the C-shaped sac, so The C-shaped bladder communicates with the liquid connecting tube for filling and draining liquid through the liquid connecting tube to block and relax the urethra.
  • the support ring is configured to be elastically deformed when the pressure in the support ring is higher than a threshold. Open.
  • the support ring is configured to maintain its shape unchanged or return to its original shape before elastic deformation when the pressure in the support ring is less than or equal to the threshold value.
  • the support ring is configured to maintain a constant elastic force during elastic deformation.
  • the support ring is made of a material with a super-elastic effect or a combination of at least two spring plates, wherein the material is preferably a nickel-titanium alloy.
  • the support ring includes a first section, a second section, a third section, and a fourth section that are sequentially connected, wherein the second section and the third section constitute The C-shaped body portion of the support ring, the first section is bent from one end of the second section in a direction opposite to the bending direction of the second section, and the fourth section is from the third section One end is bent in a direction opposite to the bending direction of the third section, wherein the first section and the fourth section are from the one end of the second section and the third section, respectively The ends first approach each other until they touch each other and then move away from each other.
  • a pressure sensor is provided between the C-shaped bladder and the support ring.
  • the C-shaped bladder and the support ring are molded into one body by die casting.
  • the C-shaped bladder, the support ring and the pressure sensor are molded into one body by die casting.
  • an internal machine for controlling urinary incontinence the internal machine is completely implanted in the body, and the internal machine includes the urethral blocker according to the first aspect of the present disclosure .
  • an automatic control system for urinary incontinence includes an external machine located outside the body and an internal machine fully implanted in the body.
  • the urethral blocker described in the third aspect is provided.
  • Fig. 1 is a schematic block diagram of an automatic control system for urinary incontinence according to the present disclosure
  • FIG. 2 is a circuit block diagram of an embodiment of the in vitro wireless transmission module of the external machine and the in vivo wireless transmission module of the internal machine of the urinary incontinence automatic control system according to the present disclosure
  • Figure 3 is a schematic diagram of the internal machine of the urinary incontinence automatic control system according to the present disclosure
  • FIG. 4 is a schematic diagram of the internal structure of the control box of the internal machine of the automatic control system for urinary incontinence according to the present disclosure
  • Fig. 5 is a schematic diagram of a liquid storage bag of the internal machine of the urinary incontinence automatic control system according to the present disclosure
  • Fig. 6 is a schematic diagram of the first state of the urethral blocker according to the present disclosure
  • FIG. 7 is a schematic diagram of the second state of the urethral obstruction device according to the present disclosure.
  • FIG. 8 is a schematic diagram of the third state of the urethral blocker according to the present disclosure.
  • FIG. 9 is a schematic diagram of a fluid connection of the internal machine of the urinary incontinence automatic control system according to the present disclosure.
  • Fig. 10 is a schematic diagram of the first flow state of the liquid circuit connection shown in Fig. 9;
  • Fig. 11 is a schematic diagram of a second flow state of the liquid circuit connection shown in Fig. 9;
  • Fig. 12 is a schematic diagram of a third flow state of the liquid circuit connection shown in Fig. 9;
  • Fig. 13 is a schematic diagram of a fourth flow state of the liquid circuit connection shown in Fig. 9;
  • Fig. 14 is a schematic diagram of a fifth flow state of the liquid path connection shown in Fig. 9.
  • the system described in this specification can utilize one or more microcontrollers to receive information and transform the received information to generate output.
  • the microcontroller may include any type of computing device, computing circuit, or any type of microcontroller or processing circuit capable of executing a series of instructions stored in a memory.
  • the microcontroller may include multiple microcontrollers and/or a multi-core central processing unit (CPU) and may include any type of microcontroller.
  • the microcontroller may also include memory to store data and/or algorithms to execute a series of instructions.
  • Fig. 1 shows a schematic block diagram of an automatic control system for urinary incontinence according to the present disclosure.
  • the urinary incontinence automatic control system of the present disclosure is used to treat urinary incontinence caused by sphincter relaxation.
  • the automatic control system for urinary incontinence includes an external machine 100 and an internal machine 200.
  • the internal machine 200 can be completely implanted inside the body, and it can be used to complete the main function of an artificial urethral sphincter.
  • the extracorporeal machine 100 can be located outside the body, and can be used to supply power to the intracorporeal machine and communicate with the intracorporeal machine, and can also complete the internal machine control, information display, and prompt alarm functions.
  • the extracorporeal machine 100 may include an extracorporeal wireless transmission module 110, an extracorporeal microcontroller 120 and a power supply module 130.
  • the power supply module 130 is connected to the external wireless transmission module 110 and the external microcontroller 120, and is used for supplying power to the external wireless transmission module 110 and the external microcontroller 120.
  • the power module 130 may be powered by a battery or by any other suitable external power source.
  • the extracorporeal microcontroller 120 is connected to the extracorporeal wireless transmission module 110.
  • the in-vivo machine 200 may include a wireless transmission module 210 in the body, a microcontroller 220 in the body, and a urethral blocker 230.
  • the in-vivo microcontroller 220 is connected to the in-vivo wireless transmission module 210.
  • the in-vivo microcontroller 220 is configured to control the urethral blocker 230 to block and release the urethra.
  • the external wireless transmission module 110 and the internal wireless transmission module 210 are wirelessly coupled.
  • the external wireless transmission module 110 is configured to transmit electrical energy to the internal wireless transmission module 210 so as to supply power to the internal machine 200.
  • the external wireless transmission module 110 and the internal wireless transmission module 210 can perform two-way wireless communication to transmit information.
  • the external wireless transmission module 110 may include a driving circuit, an information reading and writing circuit of the external machine, and an external coil Wp1.
  • the in-vivo wireless transmission module 210 may include an in-vivo coil Ws1, an in-vivo information reading circuit of the in-vivo machine, an in-vivo information writing circuit of the in-vivo machine and a power supply circuit.
  • the driving circuit is connected to the extracorporeal coil Wp1 and is configured to output an alternating electrical signal to the extracorporeal coil Wp1.
  • the extracorporeal coil Wp1 is configured to generate an alternating magnetic field.
  • the in-body coil Ws1 is configured to generate an induced electromotive force based on the alternating magnetic field.
  • the power supply circuit is connected to the in-body coil Ws1 and is used to provide stable electric energy for the in-body machine.
  • the power supply circuit can also be connected to an energy storage element such as a rechargeable battery.
  • the information read and write circuit of the external machine, the external information read circuit of the internal machine, and the internal information write circuit of the internal machine are configured to modulate the information to be communicated on the electromagnetic wave that transmits energy to send and receive The signal is demodulated into readable information, so that information can be transmitted bidirectionally between the external machine 100 and the internal machine 200.
  • Both the extracorporeal coil Wp1 and the intracorporeal coil Ws1 include magnets, such as low eddy current magnets, so that the extracorporeal coil Wp1 and the intracorporeal coil Ws1 can be positioned with each other using the new attractive force of the magnet, ensuring good coupling of the two coils.
  • the drive circuit drives a current with a certain waveform to generate an alternating magnetic field through the external coil, and generates an induced electromotive force on the internal coil Ws1 coupled with the external coil, which is supplied by the internal machine.
  • the rectification, filtering and voltage stabilization of the circuit can provide a stable DC voltage for other parts in the body.
  • the communication information is modulated to the electromagnetic wave that transmits energy according to certain rules, so that the energy and information transmission share a set of electromagnetic transmission coils. This achieves the effects of simple structure, efficient energy transmission and reliable two-way information transmission.
  • FIG. 2 shows a circuit block diagram of an embodiment of the in vitro wireless transmission module 110 and the in vivo wireless transmission module 210 according to the present disclosure.
  • Wp1 is an extracorporeal coil for outputting energy and information to the intracorporeal coil Ws1.
  • the driving circuit outputs a certain frequency alternating power electric signal to the external coil Wp1.
  • the information reading and writing circuit of the external machine includes a current sensing circuit and a comparator, wherein the current sensing circuit is used to detect the current of the external coil Wp1 and convert the current value into a voltage According to the two sets of signals, the output voltage of the current sensing circuit and the threshold voltage output by the external microcontroller 120, the comparator parses the information sent by the internal machine 200.
  • the external microcontroller 120 starts/stops the drive circuit according to a predetermined communication frequency (far lower than the frequency of the power electrical signal output by the drive circuit) to send information to the internal computer.
  • Ws1 is an in-vivo coil for receiving energy sent by the in-vivo coil Wp1.
  • the AC signal received by the internal coil Ws1 is converted into a DC voltage through the first matching network and the first rectifier filter circuit with a first time constant, which is used to provide electrical energy to the internal machine 200.
  • the external information readout circuit of the internal machine and the power supply circuit share the first matching network, but the second rectifier filter circuit with the second time constant is used to convert the presence/absence of the Ws1 received energy into the high/low voltage signal and send it to the internal body Microcontroller 220.
  • the first time constant is greater than the second time constant.
  • the signal that changes with the predetermined communication frequency can interpret the information transmitted by the external machine, and the low level exceeding a certain period of time can be used as a judgment basis for the power supply interruption of the external machine 100.
  • the AC switch connects the second matching network to the internal coil Ws1, which causes the equivalent impedance of the corresponding external coil Wp1 to change. In this way, the information is transmitted to the extracorporeal machine 100.
  • the first matching network and the second matching network may be impedance matching networks.
  • the impedance matching network may be a circuit in which series and parallel reactive elements perform impedance matching.
  • an appropriate working frequency is selected, for example, a working frequency of 100 kHz to 4 MHz is adopted to minimize the comprehensive loss of the transmission coil and the switching element.
  • Both the internal coil and the external coil are connected in series and/or in parallel with appropriate reactive elements (capacitors or inductances) for impedance matching to improve energy transmission efficiency.
  • an information transmission baud rate far lower than the operating frequency of energy transmission is selected.
  • the drive circuit turns on/stops the driving of the extracorporeal coil Wp1 in a timely manner.
  • the intracorporeal machine 200 detects the presence/absence of the output voltage of the intracorporeal coil Ws1 and interprets the information according to a predetermined coding rule.
  • the equivalent impedance of the external coil Wp1 is changed by means of an AC switch or AC switch + matching capacitor to short-circuit the internal coil Ws1, thereby changing the current of the external coil Wp1.
  • the transmitted information can be interpreted according to the predetermined coding rules.
  • the external machine 100 may also include a display and control module 140, an alarm module 150, a Bluetooth module 160 and/or a WIFI module.
  • the power supply module 130 is connected to the display and control module 140, the alarm module 150, the Bluetooth module 160 and/or the WIFI module 170, so as to supply power to them.
  • the display and control module 140 is connected to the external microcontroller 120.
  • the display and control module 140 is used to display operating information of the urinary incontinence automatic control system and to input operating commands and parameters.
  • the display and control module 140 can display the remaining battery capacity in real time, and prompt replacement and charging when the capacity reaches the lower limit.
  • the display and manipulation module 140 may include a touch screen.
  • the display and manipulation module 140 may also be composed of a separate display screen and an input device such as a keyboard.
  • the alarm module 150 is connected to the external microcontroller 120.
  • the alarm module 150 is used to send an alarm signal of system abnormality to the user.
  • the alarm signal may be a sound signal and/or a light signal.
  • the Bluetooth module 160 and/or the WIFI module 170 are connected to the external microcontroller 120.
  • the Bluetooth module 160 and/or the WIFI module 170 are configured to communicate with a cloud server or a mobile terminal such as a mobile phone, upload system operating conditions, and prompt the patient or caregiver to urinate through the mobile terminal, and can use the APP software on the mobile terminal Monitor system operation status.
  • the external wireless transmission module 110 and the internal wireless transmission module 210 transmit the urination command to the internal microcontroller 220, and the internal microcontroller 220 controls the actuator to make the urethral obstruction in a released state, Urination begins.
  • the wireless communication module transmits the close command to the internal microcontroller 220, and the internal microcontroller controls the actuator to make the urethral obstructor in a closed state, and urination ends.
  • the urethral blocker 230 may include a clamping mechanism.
  • the clamping and closing mechanism can realize clamping and closing of the urethra through various driving methods.
  • the function of clamping the urethra can be accomplished by filling or releasing liquid into the sac wrapped around the urethra (driven by hydraulic pressure); according to the principle of the electromagnet, the clamping mechanism is driven by the electromagnet to complete the clamping of the urethra.
  • Closing function (driven by electromagnetic force); the operation of the motor drives the clamping mechanism to complete the clamping function of the urethra (driven by the mechanical force generated by the motor); the use of shape memory alloys such as nickel-titanium alloys will expand when the temperature changes Open/close two-way memory effect to complete the clamping function of the urethra (driven by the force generated by the shape memory alloy when the temperature changes); or use the bimetallic sheet to deform when the temperature changes due to the difference in the metal expansion coefficient Complete the clamping function of the urethra (driven by the force generated by the bimetallic sheet when the temperature changes) and so on.
  • shape memory alloys such as nickel-titanium alloys will expand when the temperature changes Open/close two-way memory effect to complete the clamping function of the urethra (driven by the force generated by the shape memory alloy when the temperature changes); or use the bimetallic sheet to deform when the temperature changes due to the difference in the metal expansion coefficient Complete the clamping function of the urethra
  • At least two urethral blockers 230 may be provided at different positions of the urethra ( Figures 1 and 3 exemplarily show the case where two urethral blockers are provided).
  • the in-vivo microcontroller 220 is configured to control the at least two urethral blockers 230 to block the urethra in turn.
  • one urethral blocker can be used to block the urethra, while other urethral blockers are in a released state; in the next period of time, the next urethral blocker can be used to block the urethra , And make other urethral obstructors in a released state.
  • Each time period can be set to 10 minutes, 20 minutes, 30 minutes or any other reasonable length of time.
  • the internal microcontroller 220 controls each urethral obstruction device to automatically block in turn. In this way, a certain position of the urethra can be effectively prevented from being clamped for a long time, resulting in poor blood flow and tissue necrosis.
  • the internal machine 200 also includes a pump 240 (e.g., a micro pump), a solenoid valve 250 (e.g., a micro solenoid valve), and a device with the internal microcontroller 220 described above.
  • the flow rate of the pump 240 may be 3 mL/min-40 mL/min.
  • the pressure value of the pump 240 may be 5-120 kPa.
  • the pump 240, the solenoid valve 250 and the circuit board 260 are contained in a control box 280.
  • the pump 240 and the solenoid valve 250 are connected to the in-body microcontroller 220 on the circuit board 260 to be controlled by the in-body microcontroller 220.
  • the liquid storage bag 270, the urethral blocker 230, and the above-described intracorporeal coil Ws1 are arranged outside the control box 280.
  • the liquid storage bag 270, the urethral blocker 230, and the liquid storage bag 270 are connected to the pump 240 and the solenoid valve 250 in the control box 280 through the corresponding connecting pipe 290.
  • the connecting tube can be made of silica gel or any other suitable material.
  • FIG. 5 shows a schematic structure of the liquid storage bag 270.
  • the reservoir 270 may be made of a silicone rubber material that meets the biological compatibility of implantation in the human body.
  • the liquid storage bag 270 may be in the shape of an oblate, and is used to store and provide the liquid required by the urethral blocker.
  • the liquid storage bag 270 may be provided with a replenishment injection valve 2701 for percutaneous injection of replenishment liquid.
  • the rehydration injection valve 2701 can be integrally formed with the liquid storage bag 270, or can be connected to the liquid storage bag 270 through a pipe as an independent component.
  • the fluid replacement injection valve 2701 may be in the shape of a button.
  • the puncture surface of the fluid replacement injection valve 2701 is elastic, and may be a high-density rubber film, for example. This enables the puncture surface to recover due to its own elastic effect after the needle is pulled out after the fluid supplementation, and the liquid storage bag 270 can be kept sealed.
  • a needle blocking plate 2702 may be provided on the opposite side of the puncture surface.
  • the needle blocking plate 2702 can be made of a material that is not easy to be pierced to prevent the liquid storage bag 270 from being pierced during rehydration.
  • the material is, for example, PET plastic, metal plate, or the like.
  • the liquid storage bag 270 has a liquid inlet and outlet, and the liquid inlet and outlet are connected to the outside through a connecting pipe 290.
  • the urethral blocker 230 includes a C-shaped bladder 2301.
  • the C-shaped bladder 2301 surrounds the urethra 10 under the bladder neck.
  • the C-shaped capsule 2301 forms an unclosed annular capsule.
  • the unclosed annular sac can make the urinary catheter and the like smoothly inserted into the urethra when the patient has tissue edema, so as to avoid urethral damage.
  • the C-shaped bladder can be made of silicone or any other suitable material.
  • the C-shaped sac bulges and increases the pressure, and the inside of the C-shaped sac bulges to squeeze the urethra to seal the urethra (as shown in Figure 6);
  • the C-shaped sac relaxes and the urethra opens to complete the urination operation (as shown in Figure 7).
  • the C-shaped bladder 2301 is connected to the liquid storage bladder 270 through the connecting pipe 290 via the pump 240 and the solenoid valve 250 to receive the liquid filled from the liquid storage bladder 270 and release the liquid into the liquid storage bladder 270.
  • the in-vivo microcontroller 220 controls the filling and discharging of the C-shaped capsule 2301 by controlling the pump 240 and the solenoid valve 250.
  • the urethral blocker 230 further includes a support ring 2302 located outside the C-shaped balloon 2301.
  • the support ring 2302 may be configured to elastically deform and expand when the pressure in the support ring 2302 is higher than a threshold value (as shown in FIG. 8), and when the pressure in the support ring 2302 returns to below the threshold value Return to the original shape before elastic deformation (as shown in Figure 6 and Figure 7).
  • the support ring 2302 may also be configured to maintain its shape when the pressure in the support ring 2302 is less than or equal to the threshold.
  • the support ring 2302 is configured to maintain a constant elastic force during elastic deformation.
  • the threshold may be set to 20 kPa, or for female patients, the threshold may be set to 15 kPa, and for male patients, the threshold may be set to 20 kPa.
  • the threshold can also be set to other reasonable pressure values.
  • the support ring 2302 may be made of a material with a super-elastic effect, such as Nitinol or other similar materials.
  • the support ring 2302 can also be made of a combination of at least two spring plates.
  • the support ring 2302 and the C-shaped bladder 2301 can be molded into a single body by die casting of silicon rubber through a mold.
  • the support ring 2302 By using the support ring 2302 as described above, when the pressure of the contents (including tissue, C-shaped capsule, etc.) in the support ring is higher than the threshold due to tissue edema or other reasons, as shown in Figure 8, the support ring generates elastic force It is deformed and gradually enlarged, so that it can leave a buffer space for the urethra and other tissues to prevent uncontrollable long-term urethral blockage or excessive bladder pressure caused by tissue ischemic necrosis and upper urinary tract disease. When the pressure drops, the support ring can automatically return to position and restore function.
  • the shape of the support ring 2302 is designed as described below.
  • the support ring may include a first section 2302A, a second section 2302B, a third section 2302C, and a fourth section 2302D that are connected in sequence.
  • the second section 2302B and the third section 2302C constitute the C-shaped main body part of the support ring 2302.
  • the first section 2302A is bent in a direction opposite to the bending direction of the second section 2302B from one end of the second section 2302B, and the fourth section 2302D is bent from one end of the third section 2302C to the third
  • the bending direction of the section 2302C is bent in the opposite direction. As shown in FIG.
  • the first section 2302A and the fourth section 2302D first approach each other from the one end of the second section 2302B and the third section 2302C, respectively. Touch and then move away from each other.
  • the above-mentioned shape of the support ring 2302 enables the support ring to provide constant support for the urethral blocker at ordinary times, and in the case of excessive pressure in the ring, the tissue can smoothly pass from the first section of the support ring
  • the mouth formed by 2302A and the fourth section 2302D escapes.
  • a pressure sensor 2303 is provided between the C-shaped bladder 2301 and the support ring 2302.
  • the support ring 2302, the C-shaped bladder 2301, and the pressure sensor 2303 can be molded into a single body by die-casting of silicon rubber through a mold.
  • the pressure sensor 2303 is, for example, a thin film pressure sensor or any suitable pressure sensor.
  • the pressure sensor 2303 is connected to the internal microcontroller 220 to send the sensed pressure signal to the internal microcontroller 220.
  • the in-vivo microcontroller 220 can collect the pressure detection value detected by the pressure sensor 2303 in real time (for example, every 100 ms).
  • the internal microcontroller 220 controls the pump and solenoid valve to release the corresponding urethral blocker 230 to loosen the urethra. This improves the safety of the system, thereby ensuring the safety of the patient.
  • the internal micro-controller 220 sends an alarm signal to the external unit 100 to cause the alarm module 150 of the external unit 100 to alarm, and the internal micro-controller 220 delays the setting
  • the corresponding urethral blocker 230 is released at a predetermined time (for example, 10 seconds), so as to give the patient sufficient preparation time and improve the user experience.
  • the internal microcontroller 220 controls the pump and the solenoid valve to send the C-shaped bladder 2301 of the urethral blocker 230 Fill the liquid until the pressure of the C-shaped bladder 2301 meets the requirements.
  • the system can operate normally even with a small amount of liquid leakage.
  • the above-mentioned maximum pressure setting value and minimum pressure setting value can be personalized according to the patient's own situation.
  • the system also adopts a number of safety protection measures to ensure that when the system fails or the power supply fails, all the urethral blockers will be released, allowing the urethra to remain free, ensuring that the system will not cause long-term urethral atresia when the system fails It causes upper urinary tract disease and improves the safety and reliability of the system.
  • the in-vivo microcontroller 220 is configured to detect the power supply voltage of the in-vivo machine in real time (for example, every 100 ms). For example, the in-vivo microcontroller 220 can determine whether the power supply voltage of the in-vivo machine is normal by detecting the potential signal in the in-vitro information readout circuit of the in-vivo machine.
  • the in-vivo microcontroller 220 is configured to control the pump and solenoid valve to immediately stop filling the urethral obstructor when it detects an abnormality in the power supply voltage of the in-body machine, and then continue to detect the power supply voltage of the in-body machine in real time; After a certain period of time (for example, 30s), the power supply voltage is still abnormal, then the internal microcontroller 220 controls the pump and solenoid valve to release all the urethral obstructors to loosen the urethra; if it is said after a set period of time (for example, 30s) When the power supply voltage returns to normal, the internal microcontroller 220 resumes normal control of the pump and solenoid valve.
  • a certain period of time for example, 30s
  • the internal machine further includes a protection circuit independent of the internal microcontroller, and the protection circuit is low when the internal machine 200 receives a signal from the external machine 100. It is triggered to control the pump and electromagnetic when the potential (for example, the level of the "downstream information readout" signal in Figure 2 is “low") and continues to exceed the set time (for example, exceeding the low-level duration of normal information transmission) The valve releases all the urethral obstruction and loosens the urethra. In this way, it is possible to trigger the protection circuit and release the urethral obstruction by only relying on the duration of the "downstream information readout" signal without relying on the microcontroller, thereby enhancing the fault tolerance and redundancy of the system.
  • the power supply circuit of the in-body machine 200 has an energy storage element for storing electric energy.
  • each solenoid valve is provided with an energy storage capacitor, which stores energy when the solenoid valve is working normally. The energy stored in the energy storage capacitor of each solenoid valve is only used for the release operation of the respective solenoid valve.
  • the intracorporeal machine 200 can be provided with at least two urethral blockers 230 at different positions of the urethra.
  • each urethral blocker 230 may have a structure as shown in FIGS. 6 to 8 and as described above.
  • FIGS. 9 to 14 illustrate, by way of example, the liquid path connection of the in-vivo machine 200 in the case of an embodiment in which two urethral blockers 230a and 230b are provided.
  • two urethral blockers 230a and 230b are provided.
  • more than two urethral obstruction devices can be installed. In this case, it is only necessary to connect a newly added urethral obstruction device in parallel at point O of the liquid path shown in FIG.
  • the newly added urethral blocker can be connected in series with a newly added solenoid valve.
  • the intracorporeal machine 200 includes a reservoir 270, a pump 240, a total solenoid valve 250A, a first urethral blocker 230a, a second urethral blocker 230b, a first urethral blocker solenoid valve 250a, and a first urethral blocker 230a.
  • the second urethral blocker solenoid valve 250b is the second urethral blocker solenoid valve 250b.
  • the respective first ends of the first urethral blocker solenoid valve 250a and the second urethral blocker solenoid valve 250b are respectively connected to the first urethral blocker 230a and the second urethral blocker 230b, the first urethral blocker
  • the second ends of the solenoid valve 250a and the second urethral blocker solenoid valve 250b are both connected to the first end of the total solenoid valve 250A, and the second end of the total solenoid valve 250A is connected to the reservoir 270
  • the first end of the pump 240 is connected to the respective second ends of the first urethra blocker solenoid valve 250a and the second urethra blocker solenoid valve 250b, and the second end of the pump 240 It is connected with the liquid inlet and outlet of the liquid storage bag 270.
  • Figures 10 and 11 schematically show a schematic diagram in which the first urethral obstructor 230a clamps the urethra and the second urethral obstructor 230b loosens the urethra.
  • the internal controller 220 controls the pump 240 to start, the first urethral blocker solenoid valve 250a is opened, the main solenoid valve 250A and the second urethra blocker solenoid valve 250b are closed, and the reservoir 270 is now The liquid is injected into the first urethral blocker 230a through the pump 240 and the first urethral blocker solenoid valve 250a.
  • the liquid in the first urethral blocker 230a increases and expands to completely close the urethra.
  • the pump 240 stops working.
  • the first urethral blocker solenoid valve 250a is turned off to maintain pressure, while the main solenoid valve 250A and the second urethral blocker solenoid valve 250b are opened, and the liquid in the second urethral blocker 230b returns to the reservoir 270 by its own tension.
  • the second urethra blocker 230b is released, and the urethra is clamped by loosening.
  • Figures 12 and 13 schematically show a schematic diagram of the second urethral obstruction device 230b clamping the urethra and the first urethral obstruction device 230a releasing the urethra.
  • the internal controller 220 controls the pump 240 to start, the second urethral blocker solenoid valve 250b is opened, the main solenoid valve 250A and the first urethra blocker solenoid valve 250a are closed, and the reservoir 270 is now
  • the liquid is injected into the second urethral blocker 230b through the pump 240 and the second urethral blocker solenoid valve 250b.
  • the liquid in the second urethral blocker 230b continues to increase and expand to completely close the urethra.
  • the pump 240 stops working.
  • the second urethral blocker solenoid valve 250b is turned off to maintain pressure, while the main solenoid valve 250A and the first urethral blocker solenoid valve 250a are opened, and the liquid in the first urethral blocker 230a returns to the reservoir 270 by its own tension.
  • the first urethra blocker 230a is released, and the urethra is clamped by loosening.
  • Fig. 14 schematically shows the flow state in which the urethral blocker is fully released.
  • the main solenoid valve 250A, the first urethra blocker solenoid valve 250a, and the second urethra blocker solenoid valve 250b are all opened, and the liquid in the first urethra blocker 230a and the second urethra blocker 230b Due to the self-tension and the internal pressure of the urethra from the bladder, it flows back into the reservoir 270 through the solenoid valves, and the urethra blockers release the pressure on the urethra. At this time, urine is discharged from the body through the urethra.
  • the two urethral blockers automatically compress the urethra in turn at regular intervals (for example, 20 minutes), and prevent tissue necrosis due to long-time clamping of the urethra and poor tissue blood flow.
  • the present disclosure can be applied to automatic control of urinary incontinence, and therefore has industrial applicability.

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Abstract

一种尿道阻断器（230、230a、230b）、用于控制尿失禁的体内机（200）和尿失禁自动控制系统。尿道阻断器（230、230a、230b）包括C形囊（2301）以及位于C形囊（2301）外侧的支撑环（2302），C形囊（2301）与液体连接管（290）相连通，用于通过液体连接管（290）填充以及排出液体以阻断和放松尿道，支撑环（2302）被构造成在支撑环（2302）内的压力高于一阈值时产生弹性变形而张开。

Description

尿道阻断器、尿失禁自动控制系统及其体内机 技术领域
本公开涉及一种尿道阻断器。本公开还涉及一种包括该尿道阻断器的用于控制尿失禁的体内机以及包括该体内机的尿失禁自动控制系统。
背景技术
尿失禁在老年人群中比较多见，也有一些治疗方法，但仍有大量患者没有有效治疗手段，只能依靠持续导尿或尿垫、尿裤等姑息措施，因而导致患者生活质量的严重下降，同时也给患者的家庭带来极大的困扰。因此临床上需要开发新的尿失禁治疗装置。
临床上已经开发出一种人工尿道括约肌装置，其优点是既能恢复对排尿的控制,又能通过正常尿道排尿,并不影响括约肌和附近组织的解剖结构,病人能获得较好的生活质量。但是，现有的人工尿道括约肌装置也存在一些缺陷。例如，现有的人工尿道括约肌装置可靠性较低，例如其在特定情况下可能会对尿道组织的过度压迫，从而对尿道组织造成损伤。
发明内容
针对现有的人工尿道括约肌装置中的至少一个缺陷，本公开的目的之一是提供一种尿道阻断器，所述尿道阻断器包括C形囊以及位于C形囊外侧的支撑环，所述C形囊与液体连接管相连通，用于通过液体连接管填充以及排出液体以阻断和放松尿道，所述支撑环被构造成在支撑环内的压力高于一阈值时产生弹性变形而张开。
在一种构造中，所述支撑环被构造成在支撑环内的压力小于或等于所述阈值时维持形状不变或回复弹性变形前的原形状。
在一种构造中，所述支撑环被构造成在弹性变形过程中弹力保持恒定。
在一种构造中，所述支撑环由具有超弹性效应的材料制成或者由至少两个弹簧片组合制成，其中所述材料优选为镍钛合金。
在一种构造中，所述支撑环包括依次相连的第一部段、第二部段、第三部段和第四部段，其中所述第二部段和所述第三部段构成了所述支撑环的C形主体部分，所述第一部段从第二部段的一端在与第二部段的弯曲方向相反的方向上弯曲，所述第四部 段从第三部段的一端在与第三部段的弯曲方向相反的方向上弯曲，其中所述第一部段和所述第四部段分别从第二部段的所述一端和所述第三部段的所述一端起首先彼此靠近直至彼此接触然后再彼此远离。
在一种构造中，在所述C形囊和所述支撑环之间设置有压力传感器。
在一种构造中，所述C形囊和所述支撑环利用压铸成型而模制成一体。
在一种构造中，所述C形囊、所述支撑环和所述压力传感器利用压铸成型而模制成一体。
在本公开的第二方面中，提供了一种用于控制尿失禁的体内机，所述体内机完全植入身体内，所述体内机包括根据本公开第一方面所述的尿道阻断器。
在本公开的第三方面中，提供了一种尿失禁自动控制系统，所述尿失禁自动控制系统包括位于体外的体外机和完全植入身体内的体内机，所述体内机包括根据本公开第三方面所述的尿道阻断器。
附图说明
当参照附图阅读以下详细描述时本公开的这些和其它特征、方面和优势将变得理更好理解，在所述附图中，相同的附图标记表示相同的零件，其中：
图1是根据本公开的尿失禁自动控制系统的示意框图；
图2是根据本公开的尿失禁自动控制系统的体外机的体外无线传输模块和体内机的体内无线传输模块的一种实施方式的电路框图；
图3是根据本公开的尿失禁自动控制系统的体内机的示意图；
图4是根据本公开的尿失禁自动控制系统的体内机的控制盒的内部结构示意图；
图5是根据本公开的尿失禁自动控制系统的体内机的储液囊的示意图；
图6是根据本公开的尿道阻断器的第一种状态的示意图；
图7是根据本公开的尿道阻断器的第二种状态的示意图；
图8是根据本公开的尿道阻断器的第三种状态的示意图；
图9是根据本公开的尿失禁自动控制系统的体内机的一种液路连接的示意图；
图10是图9所示的液路连接的第一流动状态的示意图；
图11是图9所示的液路连接的第二流动状态的示意图；
图12是图9所示的液路连接的第三流动状态的示意图；
图13是图9所示的液路连接的第四流动状态的示意图；以及
图14是图9所示的液路连接的第五流动状态的示意图。
具体实施方式
以下将参照附图描述本公开，其中的附图示出了本公开的若干实施例。然而应当理解的是，本公开可以以多种不同的方式呈现出来，并不局限于下文描述的实施例；事实上，下文描述的实施例旨在使本公开的公开更为完整，并向本领域技术人员充分说明本公开的保护范围。还应当理解的是，本文公开的实施例能够以各种方式进行组合，从而提供更多额外的实施例。
应当理解的是，说明书中的用辞仅用于描述特定的实施例，并不旨在限定本公开。说明书使用的所有术语(包括技术术语和科学术语)除非另外定义，均具有本领域技术人员通常理解的含义。为简明和/或清楚起见，公知的功能或结构可以不再详细说明。
说明书使用的用辞“包括”、“包含”和“含有”表示存在所声称的特征，但并不排斥存在一个或多个其它特征。说明书使用的用辞“和/或”包括相关列出项中的一个或多个的任意和全部组合。
说明书使用的用词“连接”、“相连”或类似用词旨在表示直接连接和/或间接连接。
本说明书描述的系统可利用一个或多个微控制器来接收信息并变换所接收的信息以生成输出。该微控制器可包括任意类型的计算装置、计算电路或者任意类型的微控制器或能够执行存储在存储器中的一系列指令的处理电路。该微控制器可包括多个微控制器和/或多核中央处理单元(CPU)并且可包括任意类型的微控制器。该微控制器还可包括存储器以存储数据和/或算法以执行一系列指令。
图1示出了根据本公开的尿失禁自动控制系统的示意性框图。本公开的尿失禁自动控制系统用于治疗括约肌松弛导致的尿失禁。尿失禁自动控制系统包括体外机100和体内机200。所述体内机200可以完全植入身体内部，其可以用于完成人工尿道括约肌的主要功能。所述体外机100可以位于身体外部，其可以用于给体内机供电及与体内机通讯，还可以完成体内机控制及信息显示以及提示报警功能。
如图1所示，所述体外机100可以包括体外无线传输模块110、体外微控制器120和电源模块130。所述电源模块130与体外无线传输模块110以及体外微控制器120相连，用于为体外无线传输模块110和体外微控制器120供电。所述电源模块130可以由电池供电或者由任何其他合适的外部电源供电。所述体外微控制器120与所述体外无线传输模块110相连。所述体内机200可以包括体内无线传输模块210、体内微 控制器220和尿道阻断器230。所述体内微控制器220与所述体内无线传输模块210相连。所述体内微控制器220被配置成控制尿道阻断器230以阻断和松开尿道。所述体外无线传输模块110与所述体内无线传输模块210无线地耦联。所述体外无线传输模块110被配置成用于向所述体内无线传输模块210传输电能从而为体内机200供电。所述体外无线传输模块110与所述体内无线传输模块210之间能够进行双向无线通讯以传输信息。
所述体外无线传输模块110可以包括驱动电路、体外机的信息读写电路以及体外线圈Wp1。所述体内无线传输模块210可以包括体内线圈Ws1、体内机的体外信息读出电路、体内机的体内信息写入电路以及供电电路。所述驱动电路与所述体外线圈Wp1相连并且被配置成用于向体外线圈Wp1输出交变的电信号。所述体外线圈Wp1被配置成用于产生交变磁场。所述体内线圈Ws1被配置成基于所述交变磁场产生感应电动势。所述供电电路与所述体内线圈Ws1相连，用于为体内机提供稳定的电能。所述供电电路还可以与诸如可充电电池的储能元件相连。所述体外机的信息读写电路、所述体内机的体外信息读出电路和体内机的体内信息写入电路被配置成用于将待通讯的信息调制到传输能量的电磁波上发送并且将接收的信号解调成可读取信息，从而在体外机100和体内机200之间双向传递信息。所述体外线圈Wp1和所述体内线圈Ws1均包括磁铁，诸如低涡流磁铁，使得所述体外线圈Wp1和所述体内线圈Ws1能够利用磁铁的新引力而彼此定位，保证两个线圈的良好耦合。
由此，在由体外机100对体内机200供电时，驱动电路驱动具有一定波形的电流通过体外线圈产生交变磁场，在与体外线圈耦合的体内线圈Ws1上产生感应电动势，经过体内机的供电电路的整流、滤波和稳压等处理，可以为体内机中的其他部件提供稳定的直流电压。当在体外机100和体内机200之间进行信息传输时，通讯信息按照一定规则被调制到传输能量的电磁波上，使能量与信息传输共用一套电磁传输线圈。这达到了结构简单，能量传输高效和双向信息传输可靠的效果。
图2示出了根据本公开的体外无线传输模块110和体内无线传输模块210的一种实施方式的电路框图。
在体外无线传输模块110中，Wp1为体外线圈，用于向体内线圈Ws1输出能量和信息。驱动电路向体外线圈Wp1输出一定频率的交变功率电信号。体外机的信息读写电路(具体地可以是体外机的体内信息读出电路)包括电流传感电路和比较器,其中电流传感电路用于检测体外线圈Wp1的电流并且将电流值变换为电压信号，比 较器根据电流传感电路的输出电压和体外微控制器120输出的阈值电压这两组信号解析出体内机200发出的信息。体外微控制器120按照预定的通讯频率(远低于驱动电路输出的功率电信号频率)启/停驱动电路，以向体内机送出信息。
在体内无线传输模块210中，Ws1为体内线圈，用于接收体外线圈Wp1发送的能量。体内线圈Ws1接收的交流信号通过第一匹配网络和具有第一时间常数的第一整流滤波电路变换成直流电压，用于给体内机200提供电能。体内机的体外信息读出电路与供电电路共用第一匹配网络，但使用具有第二时间常数的第二整流滤波电路，将Ws1接收能量的有/无转换成为电压信号的高/低发送给体内微控制器220。其中，第一时间常数大于第二时间常数。其中以预定通讯频率变化的信号可解读出体外机下传的信息，而超过一定时长的低电平可作为体外机100供电中断的判断依据。交流开关根据体内微控制器220输出的信息，将第二匹配网络接通体内线圈Ws1，导致相应的体外线圈Wp1的等效阻抗发生改变。利用此方式，将信息传送给体外机100。在一种构造中，第一匹配网络和第二匹配网络可以是阻抗匹配网络。所述阻抗匹配网络可以是串联和并联电抗性元件进行阻抗匹配的电路。
对于体外机100向体内机200的供电，选用适当的工作频率，例如采用100kHz至4MHz工作频率，以尽量降低传输线圈和开关元件的综合损耗。体内线圈和体外线圈均通过串联和/或并联适当电抗性元件(电容或电感)进行阻抗匹配以提高能量的传输效率。
对于体外机100和体内机200之间的无线信息传输，为兼顾信息可靠传输、电磁兼容性及能量传输效率要求，选用远低于能量传输工作频率的信息传输波特率。对于体外机100向体内机200传送信息，通过驱动电路适时接通/停止对体外线圈Wp1的驱动，体内机200通过检测体内线圈Ws1输出电压的有/无，按照预定的编码规则解读出信息。对于体内机200向体外机100传送信息，采用适时以交流开关或交流开关+匹配电容短路体内线圈Ws1的方式使体外线圈Wp1的等效阻抗发生改变，从而改变体外线圈Wp1的电流。通过电流传感电路及比较器即可按照预定的编码规则解读出传输的信息。
所述体外机100还可以包括显示和操控模块140、报警模块150、蓝牙模块160和/或WIFI模块。所述电源模块130与显示和操控模块140、报警模块150、蓝牙模块160和/或WIFI模块170相连，从而为它们供电。
显示和操控模块140与所述体外微控制器120相连。显示和操控模块140用于显 示尿失禁自动控制系统的运行信息并且用于输入操作命令和参数。例如，显示和操控模块140可以实时显示电池剩余容量，在容量达到下限时提示更换和充电。显示和操控模块140可以包括触摸屏。显示和操控模块140也可以由单独的显示屏和诸如键盘的输入设备组成。
报警模块150与所述体外微控制器120相连。报警模块150用于向使用者发出系统异常的报警信号。所述报警信号可以是声音信号和/或光信号。
蓝牙模块160和/或WIFI模块170与所述体外微控制器120连接。蓝牙模块160和/或WIFI模块170被配置成能够与云端服务器或诸如手机的移动终端通信，上传系统运行情况，通过移动终端来提示患者或看护人员排尿操作，并且能够通过移动终端上的APP软件监控系统运行状况。
在使用时，当患者输入排尿命令，体外无线传输模块110和体内无线传输模块210将该排尿命令传送至体内微控制器220，体内微控制器220控制执行机构使尿道阻断器处于释放状态，排尿开始。当患者输入关闭命令，无线通信模块将关闭命令传送至体内微控制器220，体内微控制器控制执行机构使尿道阻断器处于闭合状态，排尿结束。
所述尿道阻断器230可以包括夹闭机构。所述夹闭机构可以通过各种驱动方式实现对尿道的夹闭。例如，可以通过向套在尿道上的液囊充注或释放液体来完成夹闭尿道的功能(通过液压驱动)；根据电磁铁的原理，通过电磁铁带动夹闭机构动作来完成对尿道的夹闭功能(通过电磁力驱动)；通过电机运转带动夹闭机构动作来完成对尿道的夹闭功能(通过电机产生的机械力驱动)；利用诸如镍钛合金的形状记忆合金当温度变化时会张开/闭合的双程记忆效应来完成对尿道的夹闭功能(通过形状记忆合金在温度变化时产生的力驱动)；或者利用双金属片由于金属膨胀系数的差异而在温度改变时产生形变来完成对尿道的夹闭功能(通过双金属片在温度变化时产生的力驱动)等等。
在一种构造中，可以在尿道的不同位置处设置至少两个尿道阻断器230(图1和图3例示性地示出了设置两个尿道阻断器的情况)。所述体内微控制器220被配置成控制所述至少两个尿道阻断器230轮流地阻断尿道。也就说是，在某一时段内，可以用一个尿道阻断器来阻断尿道，而使其它尿道阻断器处于释放状态；在下一时段内，用下一个尿道阻断器来阻断尿道，而使其它尿道阻断器处于释放状态。每个时段可以设置成10分钟、20分钟、30分钟或者任何其它合理的时长，由体内微控制器220控 制各尿道阻断器自动地进行轮流阻断。以这种方式，可以有效地避免尿道的某一个位置长时间地被夹闭而造成组织血流不畅和组织坏死。
下面以通过液压驱动夹闭尿道为例，结合图3至图14，详细地描述体内机以及其中的尿道阻断器的构造。
如图3和图4所示，除了上面描述过的结构以外，体内机200还包括泵240(例如微型泵)、电磁阀250(例如微型电磁阀)、具有上面描述的体内微控制器220的电路板260和储液囊270。其中，所述泵240的流量可以为3mL/min-40mL/min。所述泵240的压强值可以为5-120kPa。其中，所述泵240、所述电磁阀250和所述电路板260被容纳在控制盒280内。所述泵240、所述电磁阀250与电路板260上的体内微控制器220相连以由所述体内微控制器220控制。所述储液囊270、所述尿道阻断器230和上面描述的体内线圈Ws1设置在控制盒280外。所述储液囊270和所述尿道阻断器230以及所述储液囊270通过相应的连接管290与控制盒280内的泵240和电磁阀250连接。所述连接管可以由硅胶或者任何其它合适的材料制成。
图5示出了储液囊270的示意性结构。储液囊270可以由满足植入人体生物学兼容的硅橡胶材料制成。储液囊270可以呈扁球形状，用于储存和提供尿道阻断器所需的液体。储液囊270可以设有补液注射阀2701，用于经皮注射入补充液体。补液注射阀2701可与储液囊270一体形成，也可作为独立部件通过管道与储液囊270相连接。补液注射阀2701可以为纽扣形状。补液注射阀2701的穿刺面具有弹性，例如可以是高密度的橡胶膜。这使得当补液完成拔出针后，穿刺面由于自身的弹性作用恢复，可以保持储液囊270的密封。在所述穿刺面的相对侧可以设置阻针板2702。所述阻针板2702可以由不易被刺穿的材料制成，以防止储液囊270在补液时被刺穿，所述材料例如为PET塑料、金属板或类似物。储液囊270具有进出液口，所述进出液口通过连接管290与外界连接。
图6至图8示出了尿道阻断器230的一种实施方式。如所示，所述尿道阻断器230包括C形囊2301。所述C形囊2301环绕在膀胱颈下的尿道10上。C形囊2301形成了未封闭的环状囊。未封闭的环状囊可以在患者有组织水肿的情况下使得尿导管等顺利插入尿道，避免尿道损伤。C形囊可以由硅胶或者任何其它合适的材料制成。当尿道阻断器被充入液体(例如生理盐水)时C形囊鼓起升压，C形囊内侧鼓起对尿道进行挤压以封闭尿道(如图6所示)；当尿道阻断器内的液体被释放时，C形囊放松，尿道开放完成排尿操作(如图7所示)。所述C形囊2301通过连接管290经由泵240以 及电磁阀250与储液囊270相连，以接受从储液囊270充入的液体以及将液体释放到储液囊270中。所述体内微控制器220通过控制所述泵240和所述电磁阀250来控制C形囊2301的充液与放液。
在一种构造中，所述尿道阻断器230还包括位于C形囊2301外侧的支撑环2302。所述支撑环2302可以被构造成在支撑环2302内的压力高于一阈值时产生弹性变形而张开(如图8所示)，而在支撑环2302内的压力恢复到所述阈值以下时回复到弹性变形前的原形状(如图6和图7所示)。所述支撑环2302还可以被构造成在支撑环2302内的压力小于或等于所述阈值时维持形状不变。在一种构造中，所述支撑环2302被构造成在弹性变形过程中弹力保持恒定。所述阈值可以被设定为20KPa，或者对于女性患者，所述阈值可以被设定为15kPa,而对于男性患者，所述阈值可以被设定为20kPa。所述阈值也可以被设定为其它合理的压力值。
所述支撑环2302可以由具有超弹性效应的材料制成，所述材料例如为或镍钛合金或者其它类似材料。所述支撑环2302也可以由至少两个弹簧片组合制成。所述支撑环2302和所述C形囊2301可以通过模具利用硅橡胶压铸成型而模制成一体。
通过采用如上所述的支撑环2302，当支撑环内的内容物(包括组织、C形囊等)的压强由于组织水肿或其它原因而高于阈值时，如图8所示，支撑环产生弹力变形而逐渐开大，这样就可以给尿道等组织留出缓冲的空间，防止不可控的长时间尿道阻断或膀胱压力过大而导致的组织缺血坏死和上尿路病变。当压力降低时，支撑环可以自动回位，恢复功能。
在一种构造中，所述支撑环2302的形状如下所述地设计。如图6所示，所述支撑环可以包括依次相连的第一部段2302A、第二部段2302B、第三部段2302C和第四部段2302D。所述第二部段2302B和所述第三部段2302C构成了所述支撑环2302的C形主体部分。所述第一部段2302A从第二部段2302B的一端在与第二部段2302B的弯曲方向相反的方向上弯曲，所述第四部段2302D从第三部段2302C的一端在与第三部段2302C的弯曲方向相反的方向上弯曲。如图6所示，所述第一部段2302A和所述第四部段2302D分别从第二部段2302B的所述一端和所述第三部段2302C的所述一端起首先彼此靠近直至彼此接触然后再彼此远离。支撑环2302的如上所述的形状使得，支撑环在平时可以为尿道阻断器提供恒力支撑，而在环内压力过大的情况下，组织可以顺畅地从支撑环的由第一部段2302A和所述第四部段2302D构成的嘴部逸出。
在一种构造中，所述C形囊2301和所述支撑环2302之间设置有压力传感器2303。 所述支撑环2302、所述C形囊2301和所述压力传感器2303可以通过模具利用硅橡胶压铸成型而模制成一体。所述压力传感器2303例如是薄膜压力传感器或者任何合适的压力传感器。所述压力传感器2303与所述体内微控制器220相连以将感测到的压力信号发送给体内微控制器220。所述体内微控制器220可以实时(例如每100ms)采集所述压力传感器2303所检测到的压力检测值。
在所述压力检测值超过最高压力设定值时，所述体内微控制器220控制泵和电磁阀释放相应的尿道阻断器230以松开尿道。这提高了系统的安全性，从而保证了患者的安全。优选地，在所述压力检测值超过最高压力设定值时，所述体内微控制器220给体外机100发送报警信号使得体外机100的报警模块150报警，并且体内微控制器220延时设定的时间(例如10s)再释放相应的尿道阻断器230，从而给患者足够的准备时间，提高用户体验。
在处于充液状态的尿道阻断器230中的所述压力检测值小于最低压力设定值时，所述体内微控制器220控制泵和电磁阀向该尿道阻断器230的C形囊2301充液，直至C形囊2301的压力满足要求。这样，通过压力反馈和压力自动调节，系统在少量漏液的情况下也可以正常运行。上面所述的最高压力设定值和最低压力设定值可以根据患者自身情况进行个性化设置。
此外，系统还另外采用了多项安全保护措施，确保当系统出现故障或供电失效时，所有尿道阻断器会全部释放，让尿道保持自由状态，保证系统在失效时不会引起尿道长时间闭锁而引起上尿路病变，提高系统的安全性和可靠性。
在一种构造中，所述体内微控制器220被配置成实时(例如每100ms)检测体内机的供电电压。例如，体内微控制器220可以通过检测体内机的体外信息读出电路中的电位信号来判断体内机的供电电压是否正常。所述体内微控制器220被配置成在检测到体内机的供电电压异常时控制泵和电磁阀以立即停止向尿道阻断器充液，然后继续实时检测体内机的供电电压；如果在一段设定时间(例如30s)后所述供电电压仍为异常，则体内微控制器220控制泵和电磁阀释放全部尿道阻断器以松开尿道；如果在一段设定时间(例如30s)后所述供电电压恢复正常，则体内微控制器220恢复对泵和电磁阀的正常控制。
为了进一步增强系统的安全性，在一种构造中，所述体内机还包括独立于所述体内微控制器的保护电路，所述保护电路在体内机200从体外机100接收到的信号处于低电位(例如图2中的“下传信息读出”信号的电平为“低”)并持续超过设定时间(例 如超过正常信息传输低电平时长)的情况下被触发以控制泵和电磁阀释放全部尿道阻断器而松开尿道。这样可以不依赖微控制器，仅靠“下传信息读出”信号持续时间来触发保护电路，释放尿道阻断器，从而增强了系统的容错冗余。
为了保证体内机的供电电压异常时体内微控制器的控制操作正常进行，体内机200的供电电路具有用于存储电能的储能元件。为保证各电磁阀均有足够的能量用于其释放操作，每个电磁阀设有储能电容，所述储能电容在电磁阀正常工作时储存能量。各电磁阀的储能电容所存能量仅用于各自电磁阀的释放操作。
如前面所述，体内机200可以在尿道的不同位置处设置至少两个尿道阻断器230。在这种情况下，每个尿道阻断器230均可以具有如图6至图8以及如上文所述的结构。图9至图14以例示的方式示出了在设置两个尿道阻断器230a和230b的实施例的情况下的体内机200的液路连接。但是本领域技术人员可以想见，可以设置多于两个尿道阻断器，在这种情况下，只需要在图9所示的液路的O点处并联一个新增加的尿道阻断器并为该新增加的尿道阻断器串联一个新增加的电磁阀即可。
如图9所示，体内机200包括储液囊270、泵240、总电磁阀250A、第一尿道阻断器230a、第二尿道阻断器230b、第一尿道阻断器电磁阀250a、第二尿道阻断器电磁阀250b。第一尿道阻断器电磁阀250a和第二尿道阻断器电磁阀250b的各自的第一端分别与第一尿道阻断器230a和第二尿道阻断器230b相连，第一尿道阻断器电磁阀250a和第二尿道阻断器电磁阀250b的各自的第二端均与所述总电磁阀250A的第一端相连，所述总电磁阀250A的第二端与所述储液囊270的进出液口相连，所述泵240的第一端与第一尿道阻断器电磁阀250a和第二尿道阻断器电磁阀250b的各自的第二端相连，所述泵240的第二端与所述储液囊270的进出液口相连。
图10和图11示意性地示出了第一尿道阻断器230a夹闭尿道而第二尿道阻断器230b松开尿道的原理图。如图所示，首先，体内控制器220控制泵240启动，第一尿道阻断器电磁阀250a打开，总电磁阀250A和第二尿道阻断器电磁阀250b关闭，此时储液囊270中的液体经过泵240、第一尿道阻断器电磁阀250a注入第一尿道阻断器230a，第一尿道阻断器230a中液体不断增多、膨胀，完全关闭尿道，此时泵240停止工作，第一尿道阻断器电磁阀250a关断保压，同时总电磁阀250A和第二尿道阻断器电磁阀250b打开，第二尿道阻断器230b中的液体通过自身张力返回到储液囊270，第二尿道阻断器230b释放，松开对尿道夹闭。
图12和图13示意性地示出了第二尿道阻断器230b夹闭尿道而第一尿道阻断器 230a松开尿道的原理图。如图所示，首先，体内控制器220控制泵240启动，第二尿道阻断器电磁阀250b打开，总电磁阀250A和第一尿道阻断器电磁阀250a关闭，此时储液囊270中的液体经过泵240、第二尿道阻断器电磁阀250b注入第二尿道阻断器230b，第二尿道阻断器230b中液体不断增多、膨胀，完全关闭尿道，此时泵240停止工作，第二尿道阻断器电磁阀250b关断保压，同时总电磁阀250A和第一尿道阻断器电磁阀250a打开，第一尿道阻断器230a中的液体通过自身张力返回到储液囊270，第一尿道阻断器230a释放，松开对尿道夹闭。
图14示意性地示出了尿道阻断器全部松开的流动状态。当需要排尿时，总电磁阀250A、第一尿道阻断器电磁阀250a和第二尿道阻断器电磁阀250b全部打开，第一尿道阻断器230a和第二尿道阻断器230b中的液体由于自身张力及来自膀胱的尿道内部压力作用下通过各电磁阀回流到储液囊270中，各尿道阻断器释放对尿道的压力，这时尿经过尿道排出体外。
通过这种方式，可以确保两个尿道阻断器每隔一定时间(例如20分钟)自动轮流压紧尿道，防止因长时间夹紧尿道，组织血流不畅导致组织坏死。
工业实用性
本公开可以应用于尿失禁的自动控制，因此具有工业实用性。
尽管仅仅在此图解以及描述了本公开的特定实施例，但是本领域的技术人员能够想到多种修改方案和变形方案。因此，应当理解的是所附权利要求旨在涵盖处于本公开的真实精神范围内的所有修改方案和变形方案。

Claims (10)

  1. 一种尿道阻断器，其特征在于，所述尿道阻断器包括C形囊以及位于C形囊外侧的支撑环，所述C形囊与液体连接管相连通，用于通过液体连接管填充以及排出液体以阻断和放松尿道，所述支撑环被构造成在支撑环内的压力高于一阈值时产生弹性变形而张开。
  2. 根据权利要求1所述的尿失禁自动控制系统，其特征在于，所述支撑环被构造成在支撑环内的压力小于或等于所述阈值时维持形状不变或回复弹性变形前的原形状。
  3. 根据权利要求1所述的尿道阻断器，其特征在于，所述支撑环被构造成在弹性变形过程中弹力保持恒定。
  4. 根据权利要求1-3中任一项所述的尿道阻断器，其特征在于，所述支撑环由具有超弹性效应的材料制成或者由至少两个弹簧片组合制成，其中所述材料优选为镍钛合金。
  5. 根据权利要求1-4中任一项所述的尿道阻断器，其特征在于，所述支撑环包括依次相连的第一部段、第二部段、第三部段和第四部段，其中所述第二部段和所述第三部段构成了所述支撑环的C形主体部分，所述第一部段从第二部段的一端在与第二部段的弯曲方向相反的方向上弯曲，所述第四部段从第三部段的一端在与第三部段的弯曲方向相反的方向上弯曲，其中所述第一部段和所述第四部段分别从第二部段的所述一端和所述第三部段的所述一端起首先彼此靠近直至彼此接触然后再彼此远离。
  6. 根据权利要求1-5中任一项所述的尿道阻断器，其特征在于，在所述C形囊和所述支撑环之间设置有压力传感器。
  7. 根据权利要求1-6中任一项所述的尿道阻断器，其特征在于，所述C形囊和所述支撑环利用压铸成型而模制成一体。
  8. 根据权利要求6中任一项所述的尿道阻断器，其特征在于，所述C形囊、所述支撑环和所述压力传感器利用压铸成型而模制成一体。
  9. 一种用于控制尿失禁的体内机，所述体内机完全植入身体内，其特征在于，所述体内机包括根据权利要求1-8中任一项所述的尿道阻断器。
  10. 一种尿失禁自动控制系统，所述尿失禁自动控制系统包括位于体外的体外机和完全植入身体内的体内机，其特征在于，所述体内机包括根据权利要求1-8中任一项所述的尿道阻断器。
PCT/CN2020/130362 2019-11-22 2020-11-20 尿道阻断器、尿失禁自动控制系统及其体内机 WO2021098818A1 (zh)

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