CN110859684A

CN110859684A - Urethra blocker, urinary incontinence automatic control system and in-vivo machine thereof

Info

Publication number: CN110859684A
Application number: CN201911156193.9A
Authority: CN
Inventors: 吴双宸
Original assignee: Beijing Bikang Medical Technology Co Ltd
Current assignee: Beijing Bikang Medical Technology Co Ltd
Priority date: 2019-11-22
Filing date: 2019-11-22
Publication date: 2020-03-06
Anticipated expiration: 2039-11-22
Also published as: WO2021098818A1; CN110859684B

Abstract

A urethral blocking device, an intrabody device for controlling urinary incontinence and an automatic urinary incontinence control system. The urethral occluder includes a C-shaped balloon communicating with the liquid connection tube for filling and discharging liquid through the liquid connection tube to occlude and relax the urethra, and a support ring located outside the C-shaped balloon and configured to elastically deform to expand when a pressure inside the support ring is above a threshold value.

Description

Urethra blocker, urinary incontinence automatic control system and in-vivo machine thereof

Technical Field

The present disclosure relates to a urethral occluder. The present disclosure also relates to an in-vivo machine for controlling urinary incontinence including the urethral blocking device and an automatic urinary incontinence control system including the in-vivo machine.

Background

Urinary incontinence is common among the elderly, and some treatment methods are available, but a large number of patients still have no effective treatment means and can only rely on continuous catheterization or the palliative measures of a urine pad, a diaper and the like, so that the life quality of the patients is seriously reduced, and meanwhile, the family of the patients is also greatly troubled. There is therefore a clinical need to develop new urinary incontinence treatment devices.

An artificial urethral sphincter device has been developed clinically, which has the advantage of restoring control of urination while urinating through the normal urethra without affecting the anatomical structure of the sphincter and nearby tissues and the patient can achieve a better quality of life. However, existing artificial urinary sphincter devices also suffer from several drawbacks. For example, existing artificial urinary sphincter devices have low reliability, e.g., they may under certain circumstances over-stress the urethral tissue, thereby causing damage to the urethral tissue.

Disclosure of Invention

In view of at least one of the drawbacks of the prior art artificial urinary sphincter devices, it is an object of the present disclosure to provide a urethral blocking device including a C-shaped balloon in communication with a fluid connection tube for filling and draining fluid through the fluid connection tube to block and relax the urethra, and a support ring outside the C-shaped balloon, the support ring being configured to elastically deform to expand when the pressure within the support ring is above a threshold value.

In one configuration, the support ring is configured to maintain a shape or return to an original shape prior to elastic deformation when a pressure within the support ring is less than or equal to the threshold value.

In one configuration, the support ring is configured such that the elastic force remains constant during the elastic deformation.

In one configuration, the support ring is made of a material having a superelastic effect or a combination of at least two spring strips, wherein the material is preferably a nickel titanium alloy.

In one configuration, the support ring comprises a first section, a second section, a third section and a fourth section connected in series, wherein the second section and the third section constitute a 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 a bending direction of the second section, and the fourth section is bent from one end of the third section in a direction opposite to a bending direction of the third section, wherein the first section and the fourth section are first brought close to each other until they contact each other and then are further away from each other from the one end of the second section and the one end of the third section, respectively.

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

In one configuration, the C-shaped bladder and the support ring are molded as one piece using die casting.

In one configuration, the C-shaped bladder, the support ring, and the pressure sensor are molded as one piece using die casting.

In a second aspect of the present disclosure, an intrabody machine for controlling urinary incontinence is provided, the intrabody machine being fully implanted in a body, the intrabody machine comprising a urethral occluder according to the first aspect of the present disclosure.

In a third aspect of the present disclosure, there is provided an automatic urinary incontinence control system comprising an extra-corporeal machine located outside the body and an intra-corporeal machine implanted entirely within the body, the intra-corporeal machine including a urethral block device according to the third aspect of the present disclosure.

Drawings

These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:

FIG. 1 is a schematic block diagram of an automated urinary incontinence control system according to the present disclosure;

FIG. 2 is a block circuit diagram of one embodiment of an external wireless transmission module of an external machine and an internal wireless transmission module of an internal machine of the urinary incontinence automatic control system according to the present disclosure;

FIG. 3 is a schematic illustration of an in-vivo machine of an automated urinary incontinence control system according to the present disclosure;

fig. 4 is a schematic view of the internal structure of the control box of the in-body unit of the automatic urinary incontinence control system according to the present disclosure;

FIG. 5 is a schematic view of an in-vivo reservoir of an automated urinary incontinence control system according to the present disclosure;

FIG. 6 is a schematic view of a urethral occluder according to the present disclosure in a first state;

FIG. 7 is a schematic view of a urethral occluder in a second state according to the present disclosure;

FIG. 8 is a schematic view of a third state of a urethral occluder according to the present disclosure;

FIG. 9 is a schematic view of a fluid circuit connection of the body-machine of the automatic urinary incontinence control system according to the present disclosure;

FIG. 10 is a schematic illustration of a first flow condition of the fluid circuit connection shown in FIG. 9;

FIG. 11 is a schematic view of a second flow condition of the fluid circuit connection shown in FIG. 9;

FIG. 12 is a schematic view of a third flow state of the fluid path connection shown in FIG. 9;

FIG. 13 is a schematic view of a fourth flow condition of the fluid circuit connection shown in FIG. 9; and

fig. 14 is a schematic view of a fifth flow state of the fluid path connection shown in fig. 9.

Detailed Description

The present disclosure will now be described with reference to the accompanying drawings, which illustrate several embodiments of the disclosure. It should be understood, however, that the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, the embodiments described below are intended to provide a more complete disclosure of the present disclosure, and to fully convey the scope of the disclosure to those skilled in the art. It is also to be understood that the embodiments disclosed herein can be combined in various ways to provide further additional embodiments.

It is to be understood that the terminology used in the description is for the purpose of describing particular embodiments only, and is not intended to be limiting of the disclosure. All terms (including technical and scientific terms) used in the specification have the meaning commonly understood by one of ordinary skill in the art unless otherwise defined. Well-known functions or constructions may not be described in detail for brevity and/or clarity.

The terms "comprising," "including," and "containing" when used in this specification specify the presence of stated features, but do not preclude the presence or addition of one or more other features. The term "and/or" as used in this specification includes any and all combinations of one or more of the associated listed items.

The use of the terms "connected," "coupled," or the like in the description is intended to mean either a direct connection and/or an indirect connection.

The systems described herein may utilize one or more microcontrollers to receive information and transform the received information to generate an output. The microcontroller may comprise any type of computing device, computing circuit, or any type of microcontroller or processing circuit capable of executing a series of instructions stored in memory. The microcontroller may include multiple microcontrollers and/or multicore Central Processing Units (CPUs) and may include any type of microcontroller. The microcontroller may also include a memory to store data and/or algorithms to execute a series of instructions.

Fig. 1 shows a schematic block diagram of an automatic urinary incontinence control system according to the present disclosure. The automatic urinary incontinence control system is used for treating urinary incontinence caused by sphincter relaxation. The urinary incontinence automatic control system includes an extracorporeal machine 100 and an extracorporeal machine 200. The internal body 200 may be fully implanted inside the body, which may be used to perform the primary function of the artificial urinary sphincter. The outdoor unit 100 can be located outside the body, can be used for supplying power to the indoor unit and communicating with the indoor unit, and can also complete the functions of indoor unit control, information display and prompt alarm.

As shown in fig. 1, the outdoor unit 100 may include an outdoor wireless transmission module 110, an outdoor microcontroller 120, and a power module 130. The power module 130 is connected to the extracorporeal wireless transmission module 110 and the extracorporeal microcontroller 120, and is configured to supply power to the extracorporeal wireless transmission module 110 and the extracorporeal microcontroller 120. The power module 130 may be battery powered or powered 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 an in vivo wireless transmission module 210, an in vivo microcontroller 220, 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 extracorporeal wireless transmission module 110 is wirelessly coupled with the in-vivo wireless transmission module 210. The extracorporeal wireless transmission module 110 is configured to transmit electrical energy to the in-vivo wireless transmission module 210 to power the in-vivo machine 200. The in-vitro wireless transmission module 110 and the in-vivo 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 an external machine, and an external coil Wp 1. The in-vivo wireless transmission module 210 may include an in-vivo coil Ws1, an in-vitro information reading circuit of the in-vivo device, an in-vivo information writing circuit of the in-vivo device, and a power supply circuit. The drive circuit is connected to the extracorporeal coil Wp1 and is configured to output an alternating electrical signal to the extracorporeal coil Wp 1. The extracorporeal coil Wp1 is configured to generate an alternating magnetic field. The in-vivo coil Ws1 is configured to generate an induced electromotive force based on the alternating magnetic field. The power supply circuit is connected with the in-vivo coil Ws1 and is used for supplying stable electric energy to the in-vivo machine. The power supply circuit may also be connected to an energy storage element, such as a rechargeable battery. The information read-write circuit of the external machine, the external information read-out circuit of the internal machine, and the internal information write-in circuit of the internal machine are configured to modulate information to be communicated onto electromagnetic waves for transmitting energy and demodulate received signals into readable information, thereby bidirectionally transferring information between the external machine 100 and the internal machine 200. The extracorporeal coil Wp1 and the intracorporeal coil Ws1 each include a magnet, such as a low eddy current magnet, so that the extracorporeal coil Wp1 and the intracorporeal coil Ws1 can be positioned to each other with a new attractive force of the magnets, ensuring good coupling of the two coils.

Therefore, when the external machine 100 supplies power to the internal machine 200, the driving circuit drives a current with a certain waveform to generate an alternating magnetic field through the external coil, an induced electromotive force is generated on the internal coil Ws1 coupled with the external coil, and stable direct-current voltage can be provided for other components in the internal machine through rectification, filtering, voltage stabilization and other processing of the power supply circuit of the internal machine. When information is transmitted between the external machine 100 and the internal machine 200, the communication information is modulated onto the electromagnetic wave transmitting energy according to a certain rule, so that the energy and the information transmission share one set of electromagnetic transmission coil. The effects of simple structure, high energy transmission efficiency and reliable bidirectional information transmission are achieved.

Fig. 2 shows a block circuit diagram of one embodiment of the extracorporeal wireless transmission module 110 and the intracorporeal 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 Ws 1. The drive circuit outputs an alternating power electric signal of a certain frequency to the external coil Wp 1. The information reading and writing circuit of the external body unit (specifically, the in-vivo information reading circuit of the external body unit) includes a current sensing circuit for detecting the current of the body external coil Wp1 and converting the current value into a voltage signal, and a comparator for analyzing the information sent by the internal body unit 200 according to two sets of signals, namely, the output voltage of the current sensing circuit and the threshold voltage output by the external microcontroller 120. The extracorporeal microcontroller 120 turns on/off the drive circuit at a predetermined communication frequency (much lower than the frequency of the power electrical signal output by the drive circuit) to send information to the internal body.

In the in-vivo wireless transmission module 210, Ws1 is an in-vivo coil and is used for receiving energy transmitted by the external coil Wp 1. The ac signal received by the body coil Ws1 is converted to a dc voltage by a first matching network and a first rectifying and filtering circuit with a first time constant for powering the body internal unit 200. The external information reading circuit of the internal machine shares the first matching network with the power supply circuit, but the presence/absence of the received energy of Ws1 is converted into a high/low voltage signal by using a second rectifying and filtering circuit with a second time constant, and the high/low voltage signal is sent to the internal microcontroller 220. Wherein the first time constant is greater than the second time constant. The signal with the preset communication frequency change can be used for reading the information downloaded by the outdoor unit, and the low level exceeding a certain time can be used as a judgment basis for the power supply interruption of the outdoor unit 100. The ac switch switches the second matching network on the in-vivo coil Ws1 according to the information output by the in-vivo microcontroller 220, resulting in a change in the equivalent impedance of the corresponding in-vitro coil Wp 1. In this manner, information is transmitted to the outdoor unit 100. In one configuration, the first and second matching networks may be impedance matching networks. The impedance matching network may be a circuit in which series and parallel reactive elements are impedance matched.

For the power supply from the external unit 100 to the internal unit 200, a suitable operating frequency is selected, for example, an operating frequency of 100kHz to 4MHz is adopted, so as to reduce the combined loss of the transmission coil and the switching element as much as possible. Both the in-vivo and the ex-vivo coils are impedance matched by connecting appropriate reactive elements (capacitors or inductors) in series and/or in parallel to improve the efficiency of energy transfer.

For wireless information transmission between the external machine 100 and the internal machine 200, in order to meet the requirements of reliable information transmission, electromagnetic compatibility and energy transmission efficiency, an information transmission baud rate far lower than the energy transmission working frequency is selected. When the extracorporeal unit 100 transmits information to the extracorporeal unit 200, the drive circuit appropriately turns on/off the drive of the extracorporeal coil Wp1, and the extracorporeal unit 200 decodes the information according to a predetermined coding rule by detecting the presence/absence of the output voltage of the intracorporeal coil Ws 1. For the internal machine 200 to transmit information to the external machine 100, the equivalent impedance of the external coil Wp1 is changed by adopting a mode of timely short-circuiting the internal coil Ws1 by an alternating current switch or an alternating current switch plus a matching capacitor, so that the current of the external coil Wp1 is changed. The transmitted information can be decoded according to a preset coding rule through a current sensing circuit and a comparator.

The outdoor unit 100 may further include a display and manipulation module 140, an alarm module 150, a bluetooth module 160, and/or a WIFI module. The power module 130 is connected to the display and manipulation module 140, the alarm module 150, the bluetooth module 160, and/or the WIFI module 170, thereby supplying power thereto.

A display and manipulation module 140 is connected to the extracorporeal microcontroller 120. The display and control module 140 is used to display operating information of the incontinence automatic control system and to input operating commands and parameters. For example, the display and control module 140 may display the remaining capacity of the battery in real time, and prompt replacement and charging when the capacity reaches a lower limit. The display and manipulation module 140 may include a touch screen. The display and manipulation module 140 may also be comprised of a separate display screen and input device such as a keyboard.

An alarm module 150 is connected to the extracorporeal microcontroller 120. The alarm module 150 is used for sending an alarm signal of system abnormality to a user. The alarm signal may be an acoustic signal and/or a light signal.

The bluetooth module 160 and/or the WIFI module 170 are connected with the extracorporeal microcontroller 120. Bluetooth module 160 and/or WIFI module 170 are configured to be able to communicate with a cloud server or a mobile terminal such as a cell phone, upload system operating conditions, prompt a patient or caregiver through the mobile terminal for urination operation, and be able to monitor system operating conditions through APP software on the mobile terminal.

In use, when a 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 execution mechanism to enable the urethra blocker to be in a release state, and urination is started. When the patient inputs a closing command, the wireless communication module transmits the closing command to the in-vivo microcontroller 220, the in-vivo microcontroller controls the execution mechanism to enable the urethral blocking device to be in a closed state, and urination is finished.

The urethral occluder 230 can include a clamping mechanism. The clamping mechanism can realize the clamping of the urethra through various driving modes. For example, the function of clamping the urethra (by hydraulic actuation) can be accomplished by filling or releasing a fluid into a fluid sac fitted over the urethra; according to the principle of the electromagnet, the clamping mechanism is driven by the electromagnet to act to complete the clamping function (driven by the electromagnetic force) on the urethra; the clamping mechanism is driven to act by the operation of the motor to complete the clamping function of the urethra (driven by mechanical force generated by the motor); the clamping function of the urethra is achieved by utilizing the two-way memory effect that a shape memory alloy such as nickel titanium alloy can open/close when the temperature changes (driven by the force generated by the shape memory alloy when the temperature changes); or the bimetal is deformed when the temperature changes due to the difference of the expansion coefficients of the metal to complete the clamping function of the urethra (driven by the force generated by the bimetal when the temperature changes), and the like.

In one configuration, at least two urethral blockers 230 can be disposed at different locations of the urethra (fig. 1 and 3 illustratively show the disposition of two urethral blockers). The in-vivo microcontroller 220 is configured to control the at least two urethral blockers 230 to alternately block the urethra. That is, one urethral occluder may be used to occlude the urethra while the other urethral occluders are in a released state for a certain period of time; in the next time period, the urethra is blocked with the next urethral blocker, while the other urethral blockers are in a released state. Each time period may be set to 10 minutes, 20 minutes, 30 minutes or any other reasonable time period, with the transurethral blockers being controlled by the in-vivo microcontroller 220 to automatically alternate blocking. In this way, unsmooth tissue blood flow and tissue necrosis caused by clamping a certain position of the urethra for a long time can be effectively avoided.

The construction of the intrabody machine and the urethral occluder therein will be described in detail below with reference to fig. 3 to 14, taking the example of hydraulically driving the pinching urethra.

As shown in fig. 3 and 4, in addition to the above-described structure, the in-vivo machine 200 includes a pump 240 (e.g., a micro-pump), a solenoid valve 250 (e.g., a micro-solenoid valve), a circuit board 260 having the above-described in-vivo microcontroller 220, and a reservoir 270. Wherein, the flow rate of the pump 240 can be 3mL/min to 40 mL/min. The pressure of the pump 240 may have a value of 5-120 kPa. Wherein the pump 240, the solenoid valve 250 and the circuit board 260 are accommodated in a control box 280. The pump 240, the solenoid valve 250 are connected to the in vivo microcontroller 220 on a circuit board 260 to be controlled by the in vivo microcontroller 220. The reservoir 270, the urethral blocker 230, and the in vivo coil Ws1 described above are disposed outside the control box 280. The reservoir 270 and the urethral occluder 230 and the reservoir 270 are connected to the pump 240 and the solenoid valve 250 in the control box 280 through the corresponding connection tubes 290. The connecting tube may be made of silicone or any other suitable material.

Fig. 5 shows a schematic structure of the reservoir 270. The reservoir 270 may be made of silicone rubber material that is biocompatible for implantation into the human body. The reservoir 270 may be in the form of an oblate spheroid for storing and providing the fluid needed for the urethral block device. The reservoir 270 may be provided with a supplemental fluid injection valve 2701 for transcutaneous injection of supplemental fluid. The fluid replacement injection valve 2701 may be integrally formed with the reservoir 270 or may be connected to the reservoir 270 as a separate component through a tube. The fluid replacement injection valve 2701 may be in the shape of a button. The puncture surface of the substitution injection valve 2701 has elasticity, and may be a high-density rubber film, for example. This allows the puncture surface to recover due to its elastic action after the needle is withdrawn after completion of fluid infusion, thereby maintaining the seal of the reservoir 270. A needle bar 2702 may be provided on the opposite side of the puncture surface. The needle bar 2702 may be made of a material that is not easily pierced, such as PET plastic, metal plate, or the like, to prevent the reservoir 270 from being pierced during fluid replacement. The reservoir 270 has a fluid inlet and outlet port that is connected to the outside through a connecting tube 290.

Fig. 6-8 illustrate one embodiment of urethral occluder 230. As shown, the urethral occluder 230 includes a C-shaped balloon 2301. The C-shaped balloon 2301 is looped over the urethra 10 under the bladder neck. The C-shaped bladder 2301 forms an unsealed, annular bladder. The unclosed annular sac can enable a urinary catheter and the like to be smoothly inserted into the urethra under the condition that a patient has tissue edema, so that the urethra is prevented from being damaged. The C-shaped bladder may be made of silicone or any other suitable material. When the urethral occluder is filled with liquid (such as normal saline), the C-shaped balloon bulges and pressurizes the urethra, and the inner side of the C-shaped balloon bulges and presses the urethra to seal the urethra (as shown in fig. 6); when the fluid in the urethral occluder is released, the C-shaped balloon relaxes and the urethra opens to complete the urination procedure (as shown in FIG. 7). The C-shaped bladder 2301 is connected to the reservoir 270 through a connection tube 290 via a pump 240 and a solenoid valve 250 to receive the liquid filled from the reservoir 270 and to release the liquid into the reservoir 270. The in vivo microcontroller 220 controls the filling and draining of the C-shaped bladder 2301 by controlling the pump 240 and the solenoid valve 250.

In one configuration, the urethral occluder 230 further comprises a support ring 2302 located outside the C-shaped balloon 2301. The support ring 2302 may be configured to elastically deform to expand when the pressure within the support ring 2302 is above a threshold value (as shown in fig. 8), and to return to its original shape prior to elastic deformation when the pressure within the support ring 2302 returns to below the threshold value (as shown in fig. 6 and 7). The support ring 2302 can also be configured to maintain a shape when a pressure within the support ring 2302 is less than or equal to the threshold value. In one configuration, the support ring 2302 is configured to maintain a constant spring force during elastic deformation. The threshold may be set to 20KPa, or for female patients the threshold may be set to 15KPa, and for male patients the threshold may be set to 20 KPa. The threshold value may also be set to other reasonable pressure values.

The support ring 2302 may be made of a material having a superelastic effect, such as nitinol or other similar materials. The support ring 2302 may also be made of a combination of at least two spring tabs. The support ring 2302 and the C-shaped bladder 2301 may be molded as one body by a mold using silicon rubber die casting.

By using the support ring 2302 as described above, when the pressure of the contents (including tissues, C-shaped sac, etc.) in the support ring is higher than a threshold value due to tissue edema or other reasons, as shown in fig. 8, the support ring is elastically deformed to be gradually opened, so that a buffer space is left for tissues such as urethra, etc., and tissue avascular necrosis and upper urinary tract disease caused by uncontrollable long-time urethral blockage or excessive pressure of bladder can be prevented. When the pressure is reduced, the support ring can automatically return to restore the 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 connected in series. The second section 2302B and the third section 2302C form a C-shaped body portion of the support ring 2302. The first section 2302A is bent from one end of the second section 2302B in a direction opposite to the bending direction of the second section 2302B, and the fourth section 2302D is bent from one end of the third section 2302C in a direction opposite to the bending direction of the third section 2302C. 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 one end of the third section 2302C until they contact each other and then move away from each other, respectively. The shape of the support ring 2302 as described above allows the support ring to provide constant force support for the urethral occluder at ordinary times, while allowing tissue to smoothly escape from the mouth of the support ring formed by the first section 2302A and the fourth section 2302D in the event of excessive pressure within the ring.

In one configuration, a pressure sensor 2303 is disposed 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 may be integrally molded by a mold using silicon rubber through die casting. The pressure sensor 2303 is, for example, a membrane pressure sensor or any suitable pressure sensor. The pressure sensor 2303 is connected to the in-vivo microcontroller 220 to send a sensed pressure signal to the in-vivo microcontroller 220. The in-vivo microcontroller 220 may acquire pressure detection values detected by the pressure sensor 2303 in real-time (e.g., every 100 ms).

When the pressure measurement exceeds the maximum pressure set point, the intrabody microcontroller 220 controls the pump and solenoid valve to release the corresponding urethral blocker 230 to release the urethra. This improves the safety of the system, thereby ensuring the safety of the patient. Preferably, when the pressure detection value exceeds the highest pressure setting value, the in-vivo microcontroller 220 sends an alarm signal to the external unit 100, so that the alarm module 150 of the external unit 100 gives an alarm, and the in-vivo microcontroller 220 delays the set time (for example, 10s) and then releases the corresponding urethral blocker 230, thereby providing sufficient preparation time for the patient and improving user experience.

When the pressure measurement in urethral occluder 230 in the liquid filled state is less than the minimum pressure setting, the intracorporeal microcontroller 220 controls the pump and solenoid valve to fill the C-shaped balloon 2301 of urethral occluder 230 until the pressure in C-shaped balloon 2301 is sufficient. Thus, through pressure feedback and automatic pressure regulation, the system can normally operate under the condition of small leakage. The highest pressure setting and the lowest pressure setting described above can be set individually according to the patient's own condition.

In addition, the system also adopts a plurality of safety protection measures in addition, and ensures that all the urethral blocking devices can be completely released when the system fails or the power supply fails, so that the urethra can be kept in a free state, the system can not cause the upper urinary tract lesion caused by the long-time blocking of the urethra when the system fails, and the safety and the reliability of the system are improved.

In one configuration, the in-vivo microcontroller 220 is configured to detect the supply voltage of the in-vivo device in real time (e.g., every 100 ms). For example, the in-vivo microcontroller 220 may determine whether the power supply voltage of the in-vivo device is normal by detecting a potential signal in the in-vitro information reading circuit of the in-vivo device. The in vivo microcontroller 220 is configured to control the pump and solenoid valve to immediately stop charging the urethral blocker when an abnormality in the power supply voltage of the in vivo machine is detected, and then continue to detect the power supply voltage of the in vivo machine in real time; if the supply voltage is still abnormal after a set time (e.g., 30s), the in-vivo microcontroller 220 controls the pump and solenoid valve to release all urethral blockers to release the urethra; if the supply voltage returns to normal after a set period of time (e.g., 30s), the in-vivo microcontroller 220 resumes normal control of the pump and solenoid valves.

To further enhance the safety of the system, in one configuration, the in-vivo machine further comprises a protection circuit independent of the in-vivo microcontroller, which is triggered to control the pump and solenoid valve to release all urethral blockers to release the urethra if the signal received by the in-vivo machine 200 from the in-vitro machine 100 is at a low potential (e.g., the level of the "down message read" signal in fig. 2 is "low") and lasts for more than a set time (e.g., more than the normal message transmission low level duration). Thus, the protection circuit can be triggered by the duration of the 'down information read' signal to release the urethral block device without depending on a microcontroller, thereby enhancing the fault-tolerant redundancy of the system.

In order to ensure that the control operation of the internal microcontroller is normally performed when the supply voltage of the internal machine is abnormal, the power supply circuit of the internal machine 200 has an energy storage element for storing electrical energy. In order to ensure that each solenoid valve has enough energy for the release operation of the solenoid valve, each solenoid valve is provided with an energy storage capacitor which stores energy when the solenoid valve works normally. The energy stored in the energy storage capacitor of each solenoid valve is only used for the releasing operation of each solenoid valve.

As previously described, the internal machine 200 may be provided with at least two urethral blockers 230 at different locations of the urethra. In this case, each urethral occluder 230 may have a structure as shown in fig. 6-8 and as described above. Fig. 9 to 14 show, by way of example, the fluidic connection of the internal machine 200 in the case of an embodiment in which two

urethral blockers

230a and 230b are provided. It will be appreciated by those skilled in the art that more than two urethral blockers can be provided, in which case only a newly added urethral blocker need be connected in parallel with and in series with a newly added solenoid valve at point O of the fluid path as shown in fig. 9.

As shown in fig. 9, the in vivo machine 200 includes a reservoir 270, a pump 240, a master solenoid valve 250A, a first urethral blocker 230A, a second urethral blocker 230b, a first urethral blocker solenoid valve 250A, a second urethral blocker solenoid valve 250 b. First ends of the first and second urethral

occluder solenoid valves

250A and 250b are respectively connected to the first and second urethral occluders 230A and 230b, second ends of the first and second urethral

occluder solenoid valves

250A and 250b are respectively connected to a first end of the master solenoid valve 250A, a second end of the master solenoid valve 250A is connected to the liquid inlet/outlet port of the reservoir 270, a first end of the pump 240 is connected to second ends of the first and second urethral

occluder solenoid valves

250A and 250b, and a second end of the pump 240 is connected to the liquid inlet/outlet port of the reservoir 270.

Figures 10 and 11 schematically show a principle view of a first urethral blocker 230a occluding the urethra and a second urethral blocker 230b releasing the urethra. As shown in the figure, first, the in-vivo controller 220 controls the pump 240 to start, the first urethral blocker solenoid valve 250A is opened, the total solenoid valve 250A and the second urethral blocker solenoid valve 250b are closed, at this time, the liquid in the reservoir 270 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 is continuously increased and expanded, the urethra is completely closed, at this time, the pump 240 stops working, the first urethral blocker solenoid valve 250A is turned off for pressure maintaining, the total solenoid valve 250A and the second urethral blocker solenoid valve 250b are opened, the liquid in the second urethral blocker 230b returns to the reservoir 270 by self-tension, and the second urethral blocker 230b is released to release the urethral clamping.

Fig. 12 and 13 schematically show a schematic view of second urethral blocker 230b occluding the urethra and first urethral blocker 230a releasing the urethra. As shown in the figure, first, the in-vivo controller 220 controls the pump 240 to start, the second urethral blocker solenoid valve 250b is opened, the total solenoid valve 250A and the first urethral blocker solenoid valve 250A are closed, at this time, the liquid in the reservoir 270 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 is continuously increased and expanded, the urethra is completely closed, at this time, the pump 240 stops working, the second urethral blocker solenoid valve 250b is turned off for pressure maintaining, the total solenoid valve 250A and the first urethral blocker solenoid valve 250A are opened, the liquid in the first urethral blocker 230A returns to the reservoir 270 by self-tension, the first urethral blocker 230A is released, and urethral clamping is released.

Figure 14 schematically illustrates the flow condition with the urethral occluder fully released. When the urine is required to be discharged, the master electromagnetic valve 250A, the first urethral blocker electromagnetic valve 250A and the second urethral blocker electromagnetic valve 250b are all opened, the liquid in the first urethral blocker 230A and the second urethral blocker 230b flows back to the reservoir 270 through the respective electromagnetic valves due to the tension of the liquid itself and the internal pressure of the urethra from the bladder, the respective urethral blockers release the pressure to the urethra, and then the urine is discharged out of the body through the urethra.

In this way, it is ensured that the two urethral occluders alternately and automatically compress the urethra at regular intervals (e.g., 20 minutes), preventing tissue necrosis caused by poor blood flow of the tissue due to prolonged clamping of the urethra.

Industrial applicability

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

While only certain embodiments of the disclosure have been illustrated and described herein, many modifications and changes will occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the disclosure.

Claims

1. A urethral occluder, comprising a C-shaped balloon in communication with a liquid connecting tube for filling and draining liquid through the liquid connecting tube for occluding and relaxing a urethra, and a support ring outside the C-shaped balloon, the support ring being configured to elastically deform to expand when the pressure inside the support ring is above a threshold value.

2. The automated urinary incontinence control system of claim 1 wherein said support ring is configured to maintain a constant shape or return to an original shape prior to elastic deformation when the pressure within the support ring is less than or equal to said threshold value.

3. The urethral occluder of claim 1, wherein the support ring is configured to maintain a constant spring force during elastic deformation.

4. The urethral occluder of any one of claims 1 to 3, wherein the support ring is made of a material having a superelastic effect or a combination of at least two spring blades, wherein the material is preferably a nickel titanium alloy.

5. The urethral occluder of 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 connected in series, wherein the second section and the third section constitute a C-shaped body portion of the support ring, the first section is curved from one end of the second section in a direction opposite to the direction of curvature of the second section, and the fourth section is curved from one end of the third section in a direction opposite to the direction of curvature of the third section, wherein the first section and the fourth section first approach each other until they contact each other and then move away from each other from said one end of the second section and said one end of the third section, respectively.

6. The urethral occluder of any of claims 1-5, wherein a pressure sensor is provided between the C-shaped balloon and the support ring.

7. The urethral occluder of any of claims 1-6, wherein the C-shaped balloon and the support ring are molded as one piece using die casting.

8. The urethral occluder of any of claim 6, wherein the C-shaped balloon, the support ring and the pressure sensor are molded as one piece using die casting.

9. An intrabody apparatus for controlling urinary incontinence, said apparatus being fully implanted in the body, characterized in that it comprises a urethral blocker according to any one of claims 1 to 8.

10. An automated urinary incontinence control system comprising an extra-corporeal unit located outside the body and an intra-corporeal unit implanted completely inside the body, wherein the intra-corporeal unit comprises a urethral occluder according to any one of claims 1 to 8.