WO2021098818A1

WO2021098818A1 - Urethra blocker, and urinary incontinence automatic control system and intracorporal machine thereof

Info

Publication number: WO2021098818A1
Application number: PCT/CN2020/130362
Authority: WO
Inventors: 吴双宸
Original assignee: 北京泌康医疗科技有限公司
Priority date: 2019-11-22
Filing date: 2020-11-20
Publication date: 2021-05-27
Also published as: CN110859684B; CN110859684A

Abstract

A urethra blocker (230, 230a, 230b), an intracorporal machine (200) for controlling urinary incontinence, and a urinary incontinence automatic control system. The urethra blocker (230, 230a, 230b) comprises a C-shaped balloon (2301) and a support ring (2302) located on an outer side of the C-shaped balloon (2301). The C-shaped balloon (2301) is in communication with a liquid connection pipe (290), for filling and discharging a liquid through the liquid connection pipe (290) to block and relax the urethra. The support ring (2302) is constructed to elastically deform and expand when the pressure in the support ring (2302) is higher than a threshold.

Description

Urethral blocker, urinary incontinence automatic control system and its body machine

Technical field

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.

Background technique

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. However, the existing artificial urethral sphincter devices also have some shortcomings. For example, 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.

Summary of the invention

In view of at least one defect in the existing artificial urethral sphincter device, 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.

In one configuration, 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.

In one configuration, the support ring is configured to maintain a constant elastic force during elastic deformation.

In one configuration, 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.

In one configuration, 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.

In one configuration, a pressure sensor is provided between the C-shaped bladder and the support ring.

In one configuration, the C-shaped bladder and the support ring are molded into one body by die casting.

In one configuration, the C-shaped bladder, the support ring and the pressure sensor are molded into one body by die casting.

In a second aspect of the present disclosure, there is provided 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 .

In a third aspect of the present disclosure, an automatic control system for urinary incontinence is provided. The 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.

Description of the drawings

These and other features, aspects and advantages of the present disclosure will become better understood when reading the following detailed description with reference to the accompanying drawings. In the accompanying drawings, the same reference numerals denote the same parts, in which:

Fig. 1 is a schematic block diagram of an automatic control system for urinary incontinence according to the present disclosure;

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;

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;

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; and

Fig. 14 is a schematic diagram of a fifth flow state of the liquid path connection shown in Fig. 9.

Detailed ways

The present disclosure will be described below with reference to the accompanying drawings, which illustrate several embodiments of the present disclosure. However, it should be understood that the present disclosure can be presented in a variety of different ways, and is not limited to the embodiments described below; in fact, the embodiments described below are intended to make the disclosure of the present disclosure more complete, and to contribute to the present disclosure. Those skilled in the art fully explain the protection scope of the present disclosure. It should also be understood that the embodiments disclosed herein can be combined in various ways to provide more additional embodiments.

It should be understood that the terms in the specification are only used to describe specific embodiments and are not intended to limit the present disclosure. Unless otherwise defined, all terms (including technical terms and scientific terms) used in the specification have the meanings commonly understood by those skilled in the art. For conciseness and/or clarity, well-known functions or structures may not be described in detail.

The terms "including", "including" and "containing" used in the specification indicate the presence of the claimed feature, but do not exclude the presence of one or more other features. The term "and/or" used in the specification includes any and all combinations of one or more of the related listed items.

The terms "connected", "connected" or similar terms used in the specification are intended to mean direct connection and/or indirect connection.

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.

As shown in FIG. 1, 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.

As a result, when the external machine 100 supplies power to the internal machine 200, 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. When information is transmitted between the extracorporeal machine 100 and the intracorporeal machine 200, 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.

In the extracorporeal wireless transmission module 110, 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 (specifically, the internal information reading 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.

In the in-vivo wireless transmission module 210, 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. Wherein, the first time constant is greater than the second time constant. Among them, 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. According to the information output by the internal microcontroller 220, 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. In one configuration, 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.

For the power supply of the external machine 100 to the internal machine 200, 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.

For the wireless information transmission between the extracorporeal machine 100 and the intracorporeal machine 200, in order to take into account the requirements of reliable information transmission, electromagnetic compatibility and energy transmission efficiency, an information transmission baud rate far lower than the operating frequency of energy transmission is selected. For the extracorporeal machine 100 to transmit information to the intracorporeal machine 200, 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. For the internal machine 200 to transmit information to the external machine 100, 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. Through the current sensing circuit and the comparator, 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. For example, 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.

In use, when the patient inputs a urination command, 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. When the patient inputs a close command, 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. For example, 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.

In one configuration, 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. In other words, in a certain period of time, 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.

Taking the hydraulically driven clamping of the urethra as an example, the structure of the intracorporeal machine and the urethral blocker therein will be described in detail with reference to FIGS. 3 to 14.

As shown in Figures 3 and 4, in addition to the structure described above, 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 circuit board 260 and the liquid storage bag 270. Wherein, 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. Wherein, 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.

6 to 8 show an embodiment of the urethral blocker 230. As shown, 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. When the urethral obstruction device is filled with liquid (such as physiological saline), 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); When the liquid inside is released, 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.

In one configuration, 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. In one configuration, 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.

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.

In one configuration, the shape of the support ring 2302 is designed as described below. As shown in FIG. 6, 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. 6, 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.

In one configuration, 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).

When the pressure detection value exceeds the maximum pressure setting value, 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. Preferably, when the pressure detection value exceeds the maximum pressure setting value, 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.

When the pressure detection value in the urethral blocker 230 in the filled state is less than the minimum pressure setting value, 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. In this way, through pressure feedback and automatic pressure adjustment, 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.

In addition, 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.

In one configuration, 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.

In order to further enhance the safety of the system, in a configuration, 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.

In order to ensure that the control operation of the in-body micro-controller is performed normally when the power supply voltage of the in-body machine is abnormal, the power supply circuit of the in-body machine 200 has an energy storage element for storing electric energy. In order to ensure that each solenoid valve has enough energy for its release operation, 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.

As described above, the intracorporeal machine 200 can be provided with at least two urethral blockers 230 at different positions of the urethra. In this case, 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. However, those skilled in the art can imagine that 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.

As shown in FIG. 9, 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. 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. As shown in the figure, first, 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. At this time, 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. As shown in the figure, first, 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. At this time, 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. When it is necessary to urinate, 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.

In this way, it can be ensured that 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.

Industrial applicability

The present disclosure can be applied to automatic control of urinary incontinence, and therefore has industrial applicability.

Although only specific embodiments of the present disclosure are illustrated and described herein, those skilled in the art can conceive of various modifications and variations. Therefore, it should be understood that the appended claims are intended to cover all modifications and variations within the true spirit of the present disclosure.

Claims

A urethral obstruction device, characterized in that the urethral obstruction device comprises a C-shaped sac and a support ring located outside the C-shaped sac. The C-shaped sac is communicated with a liquid connecting tube for filling through the liquid connecting tube. As well as expelling fluid to block and relax the urethra, the support ring is configured to be elastically deformed and open when the pressure in the support ring is higher than a threshold value.
The automatic urinary incontinence control system according to claim 1, wherein the support ring is configured to maintain the shape unchanged or return to the original shape before elastic deformation when the pressure in the support ring is less than or equal to the threshold value.
The urethral blocker according to claim 1, wherein the support ring is configured to maintain a constant elastic force during the elastic deformation.
The urethral blocker according to any one of claims 1 to 3, wherein the support ring is made of a material with a super-elastic effect or is made of a combination of at least two spring sheets, wherein the material Preferably, it is a nickel-titanium alloy.
The urethral blocker according to any one of claims 1 to 4, wherein the support ring comprises a first section, a second section, a third section and a fourth section that are connected in sequence, Wherein the second section and the third section constitute the C-shaped main body part of the support ring, and the first section is from one end of the second section in a direction opposite to the bending direction of the second section The fourth section is bent in a direction opposite to the bending direction of the third section from one end of the third section, wherein the first section and the fourth section are respectively bent from the second The one end of the section and the one end of the third section first approach each other until they contact each other and then move away from each other.
The urethral blocker according to any one of claims 1-5, wherein a pressure sensor is provided between the C-shaped balloon and the support ring.
The urethral blocker according to any one of claims 1 to 6, wherein the C-shaped balloon and the support ring are molded into one body by die casting.
The urethral blocker according to any one of claims 6, wherein the C-shaped balloon, 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 is characterized in that the internal machine comprises the urethral blocker according to any one of claims 1-8.
An automatic control system for urinary incontinence, the automatic control system for urinary incontinence comprises an external machine located outside the body and an internal machine fully implanted in the body, characterized in that the internal machine comprises any one of claims 1-8 The urethral blocker.