Intelligent urinary incontinence control system

By combining dual pressure sensors and machine learning algorithms, the intelligent urinary incontinence device achieves precise dynamic urinary control and early warning, solving the problems of unsatisfactory leakage control and comfort of existing devices, and providing a personalized, minimally invasive treatment solution for urinary incontinence.

CN121370433APending Publication Date: 2026-01-23BEIJING ZKSK TECH
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Patent Information

Application Number
CN202511941994.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-22
Publication Date
2026-01-23

AI Technical Summary

Technical Problem

Existing vaginal implantable urinary incontinence devices cannot sense changes in abdominal pressure in real time, resulting in unsatisfactory control of urinary leakage. They also have comfort and safety issues, cannot be adapted to the anatomical structure of different patients, and lack intelligent prediction functions.

Method used

It employs dual pressure sensors to monitor abdominal and urethral pressure, combines machine learning algorithms to predict the risk of urinary incontinence, uses biocompatible materials and ergonomic design, and integrates temperature monitoring and intelligent flow control to achieve dynamic adjustment and personalized treatment.

Benefits of technology

It achieves precise dynamic urine control, provides early warning of urine leakage, improves wearing comfort and safety, reduces the risk of infection, is easy to operate, adapts to different anatomical structures, and solves the drawbacks of traditional devices.

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Abstract

The invention discloses an intelligent urinary incontinence control system which comprises a balloon assembly matched with the vagina, a pressure sensing unit, a control unit, a driving unit, an auxiliary unit and the like. The balloon assembly is made of a biocompatible elastic material, urethral closure pressure and pressure change in the abdominal cavity are monitored in real time through the pressure sensing unit, the control unit predicts the urinary incontinence risk based on difference data and a machine learning algorithm, and the driving unit dynamically adjusts the balloon dilatation degree to enhance the urethral closure pressure. The system is further integrated with a temperature sensing module, a state indication module and the like, and tissue temperature monitoring and abnormal alarm are achieved. According to the invention, through double-sensor fusion monitoring, intelligent algorithm adjustment and multi-parameter safety control, a closed loop of'precise monitoring-intelligent decision-dynamic adjustment 'is formed, the problems of extensive pressure control, insufficient comfort and the like of a traditional device are solved, a minimally invasive, intelligent and safe solution is provided for female urinary incontinence, and the urine control efficiency and the patient experience are improved.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular, it is especially related to an intelligent urinary incontinence control system. BACKGROUND

[0002] Urinary incontinence is a common disease of the urinary system, especially in the adult female population, and stress urinary incontinence, as the most common type, refers to involuntary leakage of urine due to increased abdominal pressure caused by coughing, laughing, exercise, etc. Current clinical treatment methods include behavior therapy, drug treatment and surgical treatment, etc., but all have certain limitations. For example, although behavior therapy is non-invasive, it needs to be adhered to for a long time, and the effect is greatly affected by individual differences; drug treatment has certain effect on urge incontinence, but the effect on stress incontinence is poor, and may cause dry mouth, constipation and other side effects; surgical treatment has the problems of large trauma, many postoperative complications and high risk of recurrence. Therefore, developing a minimally invasive, intelligent and dynamically adjustable urinary incontinence management device according to the actual situation of patients has become a key problem to be solved in the current medical field.

[0003] Existing intravaginal implantable urinary incontinence devices, such as vaginal pessaries, mainly achieve the purpose of urine control by mechanically supporting the urethra, but there are many technical bottlenecks. First, in terms of pressure control, most of these devices use fixed shape or passive elastic support, which cannot dynamically adjust the pressure in real time according to the change of abdominal pressure, and it is difficult to timely enhance the support of the urethra when the abdominal pressure rises suddenly, thereby leading to unsatisfactory urine leakage control effect. Secondly, in terms of comfort and safety, the materials such as silicone or polyethylene used by the device have relatively high hardness, and long-term wearing can easily compress the vaginal mucosa, causing ischemia, ulceration and other problems, which brings discomfort to patients and increases the risk of infection. In addition, such devices are usually designed with uniform specifications, which cannot fully adapt to the anatomical structure differences of different patients, so that some patients are difficult to continuously use due to device displacement or discomfort, which seriously affects the treatment compliance.

[0004] Part of the existing intelligent urinary incontinence device attempts to achieve pressure regulation by means of elastic structure, but there are still significant deficiencies. On the one hand, only relying on a single urethral pressure sensor for monitoring, it is difficult to accurately capture the dynamic correlation between abdominal pressure and urethral pressure, making the urine control response lag, and unable to respond to urine leakage in time. On the other hand, these devices generally lack intelligent prediction algorithms, and can only take passive measures after a urine leakage event occurs, unable to provide early warning and active intervention, resulting in a large number of urine leakage events that are difficult to effectively avoid. Furthermore, the existing intelligent devices have defects in material selection and structure design, such as the elastic modulus of the elastic arm not being accurately controlled, which can easily cause local pressure to be too high and damage the urethral tissue. At the same time, most devices do not integrate temperature monitoring functions, and cannot provide timely warning of tissue ischemia risk. In addition, the antibacterial treatment on the surface of the device is simple and short-acting, and it is difficult to effectively prevent infection problems during long-term wear. These technical shortcomings seriously restrict the clinical application effect and patient experience of intelligent urinary incontinence management equipment, and urgent need for innovation breakthroughs in multi-sensor fusion, intelligent algorithm optimization, material innovation, and safety monitoring design, to improve the performance and reliability of the equipment. SUMMARY

[0005] The purpose of the present application is to solve the problems existing in the prior art, and to provide an intelligent urinary incontinence control system, comprising: An intra-vaginal implant assembly made of biocompatible elastic material, the main body being a tubular structure, the tubular body being provided with: A main balloon, which is spherical or ellipsoidal after expansion, and is adapted to the area around the urethra; At least one auxiliary balloon in fluid communication with the main balloon; A fluid channel connecting the main balloon and the auxiliary balloon, the fluid channel being filled with biocompatible liquid or gas; A pressure sensing unit provided on the surface or inside of the main balloon, comprising: A first pressure sensor integrated on the surface of the main balloon in contact with the urethra; A second pressure sensor provided on the outside or edge of the main balloon; A control unit electrically connected to the pressure sensing unit, configured to: Calculate the pressure adjustment amount based on the data difference of the first pressure sensor and the second pressure sensor through the following formula: Wherein, Pure is the urethral closure pressure, Pab is the intra-abdominal pressure, and α is the static adjustment coefficient (0.8-1.2) and β is the dynamic adjustment coefficient (0.2-0.5); Analyzing pressure data and predicting urinary incontinence risk probability through machine learning algorithm : , wherein , , , is a weight coefficient, b is a bias term, is a pressure fluctuation frequency; a driving unit, connected with the control unit and the fluid channel, comprising: a micro pump, arranged at the fluid inlet of the main balloon; a flow control valve, arranged in the fluid channel; a fixing structure, comprising: an elastic support frame, arranged around the main balloon, which is adapted to the contour of the inner wall of the vagina after the balloon is expanded; a plurality of adsorption structures or barb structures, distributed on the outer surface of the elastic support frame; the elastic modulus of the elastic support frame is in the range of 5-20 MPa; an auxiliary device for sending the intra-vaginal implant assembly to a specific position in the vagina and pulling it out from the vagina, the outer surface of the auxiliary unit is lubricated or bionic processed; an integrated block, fixedly arranged at the end of the tube body away from the uterus, comprising: an energy module, providing energy support for the driving unit; a state indicating module, comprising a vibration feedback device; a temperature sensing module, integrated in the main balloon, for measuring temperature.

[0006] Preferably, the biocompatible elastic material is medical grade silicone or thermoplastic polyurethane elastomer, the diameter of the main balloon is 3-5 cm, and the inner diameter of the fluid channel is 0.5-2 mm.

[0007] Preferably, the first pressure sensor and the second pressure sensor are piezoelectric film sensors, the machine learning algorithm is a support vector machine or a random forest model, and the weight coefficient , , determined by training clinical data.

[0008] Preferably, the micro pump and the flow control valve work cooperatively to make the pressure regulation accuracy of the main balloon reach ±0.5 mmHg, and the driving unit is configured to control the fluid flow according to the following formula: wherein Q is the fluid flow, k is the flow coefficient, and sgn is the sign function.

[0009] Preferably, the adsorption structure is a silica gel suction cup, the height of the barb structure is 0.1-0.5mm, the elastic support frame is made of nickel-titanium alloy or medical-grade silica gel, and the elastic modulus is determined by stress-strain testing.

[0010] Preferably, the outer surface of the main balloon is coated with a multilayer coating, including: an antibacterial coating containing 0.5-2wt% of silver ions or antibiotic sustained-release materials; a lubricating coating composed of polyethylene glycol, with a friction coefficient ≤0.1; a bioactive coating containing chitosan or collagen.

[0011] Preferably, the auxiliary unit includes: a push rod, a silica gel tube body, the front end of which is connected to the end of the main balloon assembly; a folding structure arranged at the connection between the push rod and the main balloon; a traction line fixed outside the integrated block.

[0012] Compared with the prior art, the present application has the following advantages: 1. Precise dynamic urine control is achieved through the cooperative monitoring technology of double pressure sensors, and the dynamic correlation between abdominal pressure and urethral pressure is captured in real time, solving the response lag problem of traditional single sensor; 2. With the help of machine learning algorithm model, early warning of urinary incontinence risk is realized; precise prediction of urinary incontinence risk, compared with traditional devices, can start intervention 1-3 seconds in advance, solve the embarrassing scene of sudden urine leakage, and improve the quality of life of patients; 3. Based on biocompatible materials and ergonomic structure, the wearing comfort and safety are improved; the friction damage to the vaginal mucosa is reduced, the risk of infection is reduced; the device is adapted to the anatomical structure of the vagina, fixed and stable without displacement, solving the problems of pain and infection hidden danger caused by traditional device compression; 4. Through minimally invasive implant design and intelligent flow control, the clinical operation and treatment experience are optimized; no surgical incision is needed for implantation, and the operation is convenient; The product realizes the technical leap from "passive leakage prevention" to "active urine control" through the closed-loop system design of "precise monitoring-intelligent decision-making-dynamic adjustment-safety guarantee", and provides a minimally invasive, intelligent and efficient new treatment option for female urinary incontinence patients. BRIEF DESCRIPTION OF DRAWINGS

[0013] Figure 1 The figure is a schematic diagram of the overall structure of an intelligent urinary incontinence control system proposed by the present application; Figure 2 The figure is a system flowchart of an intelligent urinary incontinence control system proposed by the present application; Figure 3 A functional block diagram in the judgment and decision unit of an intelligent urinary incontinence control system. DETAILED DESCRIPTION

[0014] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments.

[0015] Referring to the drawings, the present embodiment provides an intelligent urinary incontinence control system, comprising: The intravaginal implant assembly is made of a biocompatible elastic material, and the main body is a tubular structure, and the tubular body 1 is provided with: A main balloon 2, which is spherical or ellipsoidal after expansion, is adapted to the area around the urethra; here, the main balloon is implanted into the vagina through the auxiliary unit, and is positioned in the middle third to the lower third of the vaginal cavity (close to the rear of the urethra), and the specific position corresponds to the area from the middle segment of the urethra to the lower part of the bladder neck. At this time, the inner side of the main balloon (close to the urethra side) is in contact with the anterior wall of the vagina, and the anterior wall of the vagina is directly adjacent to the posterior wall of the urethra, forming a pressure transmission path of "main balloon → anterior wall of vagina → urethra". After the main balloon is implanted into the vagina, it is fixed at a specific position through image assistance, and the anterior wall of the vagina is used as a medium to indirectly apply support pressure to the urethra without directly entering the urethral cavity, which further avoids damaging the urethral mucosa or causing infection.

[0016] At least one auxiliary balloon 3 in fluid communication with the main balloon 2; A fluid channel 4 connecting the main balloon and the auxiliary balloon, the fluid channel being filled with a biocompatible liquid or gas; A pressure sensing unit arranged on the surface or inside of the main balloon, comprising: A first pressure sensor integrated on the surface of the main balloon in contact with the urethra; the sensitive element part of the first sensor is embedded in the silicone rubber material inside the main balloon, and only the sensing surface is exposed to the side in contact with the urethra, ensuring that the first sensor can accurately and directly collect the urethral closure pressure, so that the first sensor can sensitively perceive the pressure change of the urethral wall caused by factors such as changes in intravesical pressure, voluntary or involuntary contraction of the urethral sphincter, and the data collected directly reflects the actual pressure condition of the urethra maintaining the closed state to prevent urine leakage; A second pressure sensor is arranged outside or at the edge of the main balloon. If the main balloon is ring-shaped, the sensor is usually arranged on the outer circumferential surface of the main balloon away from the urethra, or at the edge of the ring structure; if the main balloon is oval-shaped, it can be located at the outer edge of the long axis or short axis direction. In actual application, this position corresponds to the area near the bladder posterior wall of the vaginal vault. For example, when the main balloon is implanted in the vagina, the second pressure sensor outside the main balloon can effectively capture the pressure signal acting on the outside of the main balloon caused by the change of intra-abdominal pressure (such as the fluctuation of intra-abdominal pressure caused by coughing, laughing, diaphragmatic descent during exercise, abdominal muscle contraction, etc.) conducted to the vaginal wall. Through such a layout of position, the second pressure sensor can monitor the change of intra-abdominal pressure in real time, and provide key data for subsequent comprehensive analysis and decision-making of the system based on the difference between intra-abdominal pressure and urethral pressure.

[0017] A control unit is electrically connected with the pressure sensing unit and is configured to: Based on the data difference of the first pressure sensor and the second pressure sensor, the pressure adjustment amount is calculated by the following formula: Wherein, Pc is the urethral closure pressure, Pi is the intra-abdominal pressure, and α is a static adjustment coefficient (0.8-1.2) and β is a dynamic adjustment coefficient (0.2-0.5); The pressure data is analyzed by a machine learning algorithm and the probability of urinary incontinence risk is predicted : Wherein , , , is a weight coefficient, and b is a bias term, is the pressure fluctuation frequency; A driving unit 8 is connected with the control unit and the fluid channel, including: a micro pump 81 arranged at the fluid inlet of the main balloon; a flow control valve 82 arranged in the fluid channel; through the driving unit arranged, the fluid in the auxiliary balloon can be pumped to the main balloon (or the fluid in the main balloon is pumped out to the auxiliary balloon), so that the main balloon is inflated (or contracted), thereby satisfying the extrusion (or relaxation) of the vaginal wall, and then realizing the control of whether the urine flows out.

[0018] A fixing structure includes: An elastic support frame 5 is fixed on the tube body and arranged around the main balloon, and its shape is adapted to the contour of the inner wall of the vagina after the main balloon is expanded; A plurality of adsorption structures or barb structures are distributed on the outer surface of the elastic support frame, which are used to fix the intra-vaginal implant assembly in the vagina after the elastic support frame is expanded; preferably, the elastic modulus of the elastic support frame is in the range of 5-20 MPa; An auxiliary device is used to send the intra-vaginal implant assembly to a specific position in the vagina and pull it out from the vagina, and the outer surface of the auxiliary unit is lubricated or bionic treated; The integrated block 6 is fixedly arranged at the end of the tube body far from the uterus, and internally arranged with: An energy module provides energy support for the driving unit, and the selection of the battery generally needs to consider volume, capacity, safety, endurance and biocompatibility, such as lithium polymer battery and micro lithium ion battery. A state indication module includes a vibration feedback device, such as a micro vibration motor, which adopts a flat eccentric rotating mass (ERM) motor (size 2x3x1mm) integrated in the integrated block, and transmits information through different vibration frequencies and time lengths. A temperature sensing module is integrated in the main balloon for measuring temperature; here, when the pressure of the main balloon is too high (such as >40 cmH2O) or the time of continuous compression is too long, the blood perfusion of the urethral and vaginal mucosal tissues may be blocked, causing local temperature rise (normal tissue temperature is 36.5-37.5℃, and when ischemic, it can rise above 38.5℃). The temperature sensing module detects the temperature change of the contact interface between the balloon and the tissue in real time, and when the detected temperature is ≥38.5℃, the state indication module is triggered to alarm, and the control unit automatically reduces the balloon pressure (such as releasing 0.3ml of liquid) to avoid tissue damage.

[0019] Further, the biocompatible elastic material is medical grade silicone or thermoplastic polyurethane elastomer, the diameter of the main balloon is 3-5cm, and the inner diameter of the fluid channel is 0.5-2mm.

[0020] Further, the first pressure sensor and the second pressure sensor are piezoelectric film sensors, the machine learning algorithm is a support vector machine or a random forest model, and the weight coefficient , , which is determined by training clinical data.

[0021] Further, the micro pump and the flow control valve work cooperatively to make the pressure regulation accuracy of the main balloon reach ±0.5mmHg, and the driving unit is configured to control the fluid flow according to the following formula: wherein Q is the fluid flow, k is the flow coefficient, and sgn is the sign function.

[0022] Furthermore, the adsorption structure is a silicone suction cup, the height of the barbed structure is 0.1-0.5mm, the elastic support frame is made of nickel-titanium alloy or medical-grade silicone, and the elastic modulus is determined by stress-strain testing.

[0023] Furthermore, the outer surface of the main balloon is coated with a multi-layer coating, including: Antibacterial coating containing 0.5-2 wt% silver ions or antibiotic sustained-release materials; The lubricating coating is made of polyethylene glycol and has a coefficient of friction ≤0.1. Bioactive coatings containing chitosan or collagen.

[0024] Preferably, the auxiliary unit includes: Push rod 71, silicone tube body, its front end is abutted to the end of the main balloon assembly; in the implantation step, by abutting push rod 71 to the end of the tube body, the implantation assembly is delivered into a specific position in the vagina in conjunction with imaging equipment (such as transvaginal ultrasound).

[0025] The traction cord 72 is fixed to the outside of the integrated block and extends out of the vagina. The traction cord 72 extends out of the vaginal opening and can be fixed to the underwear with a pad. When attaching, a certain length needs to be reserved to facilitate defecation and to facilitate the later pulling out of the implanted component placed in the vagina.

[0026] The above embodiments involve the following steps in practical use: S1, Implantation steps: The intravaginal implantation component is placed from the vagina into the area around the urethra using a pusher, and the fluid volume in the main balloon is adjusted by a micro-pump to support the elastic support frame. S2, Monitoring steps: The pressure sensing unit collects urethral closure pressure and intra-abdominal pressure data in real time; S3, Analysis Step: The control unit analyzes the pressure data difference... The probability R of urinary incontinence risk is calculated using a machine learning algorithm, which includes: ① extracting the rate of change of pressure. Pressure fluctuation frequency As features; ② Calculate the risk probability using a logistic regression model: ,in: ; ③ , , b represents the weight coefficients obtained during training, and b is the bias term. S4, Adjustment step: When the risk probability is... Exceeding the preset threshold When the value is (0.6-0.8), the drive unit adjusts the fluid volume of the main balloon according to the following formula. : ; wherein V is the current volume, γ is the volume adjustment factor (0.2-0.5 ml / mmHg) to maintain the urethral closure pressure at 20-40 cmH2O; S5, feedback step: continuously monitor and dynamically adjust the balloon pressure, while feeding back the system working status through the status indication module.

[0027] Further, the machine learning algorithm makes risk prediction based on the following features: Rate of pressure change, threshold value is ≥5 cmH2O / s; Pressure fluctuation frequency, threshold value is ≥0.5 Hz; Pressure change pattern, identify characteristic patterns such as coughing and exercise through time series analysis; The method further comprises: Automatically adjusting the pressure adjustment strategy according to the user activity pattern (standing, sitting, exercise), and correcting the risk threshold value through the following formula: wherein, δ is the activity correction factor (0.05-0.15), and ActivityLevel is the activity intensity index (0-1); Remote update of the weight parameters or pressure threshold value of the control algorithm through external equipment; Record and analyze historical pressure data and urinary incontinence events, and optimize the personalized control parameters through the following formula: wherein, is the updated weight, η is the learning rate (0.01-0.1), and L is the loss function.

[0028] The device realizes precise dynamic urine control through double pressure sensor cooperative monitoring technology, captures the dynamic correlation of abdominal pressure and urethral pressure in real time, solves the response lag problem of traditional single sensor; with the help of machine learning algorithm model, it realizes early warning of urinary incontinence risk; it accurately predicts the risk of urinary incontinence, which can start intervention 1-3 seconds earlier than traditional devices, solves the embarrassing scene of sudden urine leakage, and improves the quality of life of patients; based on biocompatible materials and ergonomic structure, it improves the comfort and safety of wearing; reduces the friction damage of vaginal mucosa and reduces the risk of infection; adapts to the anatomical structure of the vagina, is fixed and stable without displacement, solves the problems of pain and infection hidden danger caused by traditional devices; through minimally invasive implant design and intelligent flow control, it optimizes clinical operation and treatment experience; it can be implanted without surgical incision, and the operation is convenient; The product solves the drawbacks of traditional urinary incontinence devices through a closed-loop system design of "precise monitoring-intelligent decision-making-dynamic adjustment-safety guarantee", and realizes a technical leap from "passive leakage prevention" to "active urine control" through a data-driven personalized solution, thereby providing a minimally invasive, intelligent and efficient new treatment option for female patients with urinary incontinence.

[0029] The above specific embodiments further illustrate the purpose, technical solutions and advantages of the present application. It should be understood that the above are only specific embodiments of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art can make equivalent replacements or changes to the technical solutions and inventive concepts of the present application within the technical scope disclosed by the present application, which should be covered within the protection scope of the present application.

[0030] In addition, in the description of the present application, it should be understood that the terms indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0031] Furthermore, in the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting", "fixing" and the like should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or integral; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium; can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meanings of the above terms in the present application can be understood according to the specific circumstances.

Claims

1. An intelligent urinary incontinence control system, characterized in that, include: The intravaginal implant component is made of a biocompatible elastic material and consists mainly of a tubular structure. The tubular structure includes: The main balloon, when inflated, is spherical or ellipsoidal in shape and fits the area around the urethra. At least one auxiliary balloon is in fluid communication with the main balloon; A fluid channel connecting the main balloon and the auxiliary balloon, wherein the fluid channel is filled with a biocompatible liquid or gas; A pressure sensing unit, disposed on the surface or inside the main balloon, includes: The first pressure sensor is integrated into the surface of the main balloon that contacts the urethra; The second pressure sensor is located on the outside or edge of the main balloon. The control unit, electrically connected to the pressure sensing unit, is configured as follows: Based on the data difference between the first and second pressure sensors, the pressure adjustment is calculated using the following formula: ΔP = in, This refers to the pressure required for urethral closure. The intra-abdominal pressure is represented by α, which is the static adjustment coefficient (0.8-1.2), and β, which is the dynamic adjustment coefficient (0.2-0.5). Analyze stress data using machine learning algorithms and predict the probability of urinary incontinence risk. : ,in , , , Here, b is the weighting coefficient, and b is the bias term. This refers to the frequency of pressure fluctuations. The drive unit, connected to the control unit and the fluid channel, includes: A miniature pump is installed at the fluid inlet of the main balloon; A flow control valve is disposed within the fluid passage; Fixed structures, including: An elastic support frame is arranged around the main balloon, and its shape adapts to the contour of the vaginal wall after the balloon is expanded. Multiple adsorption structures or barbed structures are distributed on the outer surface of the elastic support frame; The elastic modulus of the elastic support frame is in the range of 5-20 MPa; An auxiliary device is used to insert the intravaginal implant component into a specific position inside the vagina and to pull it out of the vagina. The outer surface of the auxiliary unit is lubricated or biomimetic treated. The integrated block, fixedly installed at the end of the tube distal to the uterus, contains: The energy module provides energy support for the drive unit; Status indication module, including vibration feedback device; The temperature sensing module, integrated inside the main balloon, is used to measure temperature.

2. The intelligent urinary incontinence control system according to claim 1, characterized in that, The biocompatible elastic material is medical-grade silicone or thermoplastic polyurethane elastomer, the diameter of the main balloon is 3-5 cm, and the inner diameter of the fluid channel is 0.5-2 mm.

3. The intelligent urinary incontinence control system according to claim 1, characterized in that, The first and second pressure sensors are piezoelectric thin-film sensors, the machine learning algorithm is a support vector machine or random forest model, and the weight coefficients... , , Determined through training with clinical data.

4. The intelligent urinary incontinence control system according to claim 1, characterized in that, The micro pump and flow control valve work together to achieve a pressure regulation accuracy of ±0.5 mmHg for the main balloon. The drive unit is configured to control the fluid flow rate according to the following formula: Where Q is the fluid flow rate, k is the flow coefficient, and sgn is the sign function.

5. The intelligent urinary incontinence control system according to claim 1, characterized in that, The adsorption structure is a silicone suction cup, the height of the barbed structure is 0.1-0.5mm, the elastic support frame is made of nickel-titanium alloy or medical-grade silicone, and the elastic modulus is determined by stress-strain testing.

6. The intelligent urinary incontinence control system according to claim 1, characterized in that, The outer surface of the main balloon is coated with multiple layers of coating, including: Antibacterial coating containing 0.5-2 wt% silver ions or antibiotic sustained-release materials; The lubricating coating is made of polyethylene glycol and has a coefficient of friction ≤0.

1. Bioactive coatings containing chitosan or collagen.

7. The intelligent urinary incontinence control system according to claim 1, characterized in that, The auxiliary unit includes: The push rod, a silicone tube, has its front end abutting against the end of the main balloon assembly; The traction cord is fixed to the outer sides of both ends of the integrated block, with one end of the cord extending out of the vagina to facilitate the pulling out of the implanted component inside the vagina.