A wearable capsule-shaped smart support for pelvic organ prolapse and its application

Abstract

This invention belongs to the field of medical device technology, specifically a wearable capsule-shaped intelligent support device for pelvic organ prolapse and its application. The invention includes a main body containing a hollow, square chamber. A first air bladder, which inflates to a ring shape, is located around the outer periphery of the chamber along its length. Two second air bladders, which inflate to a hemispherical shape, are located at both ends of the chamber. The main body, when inflated, becomes elliptical. Pressure-sensing electrodes are mounted at the ends of the second air bladders. The chamber is connected to the first and second air bladders. This invention can precisely adjust the size, shape, and support strength of the uterine support device according to the degree of uterine prolapse, the physiological structure of the vagina, and individual differences among patients, ensuring patient comfort and treatment effectiveness.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a wearable capsule smart support device for pelvic organ prolapse and its application. Background Technology

[0002] Pelvic organ prolapse (POP) is a common pelvic floor dysfunction in clinical practice. For symptomatic POP patients, a pessary is one of the most common non-surgical treatments. It supports the uterus and vaginal walls, keeping them within the vagina and preventing prolapse. It can also be used as a remedy for failed pelvic floor repair surgery. However, commercially available pessaries have the following problems during use: 1. Existing models cannot cover the anatomical differences of all patients, resulting in unstable fixation or strong pressure, requiring multiple trial fittings and adjustments; 2. The pelvic floor muscles experience pressure changes during activity (such as coughing or exercising), and some pessaries cannot adapt dynamically, making them prone to displacement or detachment; 3. Traditional pessaries are rigid and not easily deformed, making them difficult to place and remove. Patients experience increased discomfort after placing a traditional pessary. Summary of the Invention

[0003] To overcome the shortcomings of the prior art, this invention provides a wearable capsule-shaped intelligent support device for pelvic organ prolapse and its application. This invention can precisely adjust the size of the pessary according to factors such as the degree of uterine prolapse, the physiological structure of the vagina, and individual differences among patients.

[0004] To achieve one of the above objectives, the present invention adopts the following technical solution: A wearable capsule-shaped smart support device for pelvic organ prolapse includes a main body with a hollow square chamber inside. A first air bladder, which becomes annular when inflated, is arranged around the outer periphery of the chamber along its length. A second air bladder, which becomes hemispherical when inflated, is located at both ends of the chamber. The main body becomes elliptical when the first and second air bladders are inflated. Pressure sensing electrode plates are installed at the ends of the second air bladders. The chamber is connected to the first and second air bladders.

[0005] Preferably, the length of the chamber is 30mm, and the width and height of the chamber are both 20mm.

[0006] Preferably, the length of the body after inflation is 70mm and the diameter after inflation is 50mm.

[0007] Preferably, a miniature air pump is installed in the cavity, and the air outlet of the miniature air pump is connected to the first airbag and the second airbag respectively.

[0008] Preferably, the main body is also equipped with a pull rope and a charging port, and the pull rope is covered with a pump tube for a miniature air pump.

[0009] Preferably, the main body is also fitted with a disposable sheath. The main body also houses an information transmission module. The information transmission module, pressure sensor, miniature air pump, and pressure sensing electrode are all connected to a software terminal and battery via a main control processing module. It can communicate with a dedicated pelvic floor support device mobile app to achieve real-time airbag volume and pressure management, thus reflecting a humanized design and improving the comfort of patients with pelvic organ prolapse.

[0010] Preferably, the information transmission module is a Bluetooth information transmission module or a WiFi information transmission module.

[0011] To achieve the second objective mentioned above, this invention provides an application of a wearable capsule-shaped smart support device for pelvic organ prolapse, the specific steps of which are as follows: S1. Determine the basic data range of the pelvic floor support intelligent equipment. Input the patient’s clinical characteristics into the database system to obtain the basic data range of surface pressure of the pelvic floor support intelligent equipment; S2, Intelligent Equipment for Pelvic Floor Support: Data Acquisition and Mobile App Interactive Control The basic shape-pressure data is transmitted through the information transmission module between the main control processing module and the patient's mobile APP. The main control processing module performs initial inflation based on the basic data sent out; it collects real-time data on pressure changes on the surface of the equipment through pressure sensing electrodes and sends it to the main control processing module. The data is then uploaded to the patient's mobile phone APP using the information transmission module between the main control processing module and the patient's mobile phone APP, enabling the patient to dynamically change the shape and size of the pelvic floor support smart equipment by adjusting the inflation volume in the airbag through the mobile phone APP, thus achieving precise individualized treatment capabilities. S3. Post-processing of collected data on mobile phones The device collects pressure changes in the vaginal wall from a patient's sitting to standing to walking to running state using pressure-sensing electrodes on both sides. The data is then uploaded via an information transmission module and processed using a Kalman filter to obtain a vaginal pressure change curve. As the patient changes their movement, they can adjust the inflation and shape of the device via an app, record the inflation volume (inflation is positive, deflation is negative), and calculate the real-time device volume. This data is then processed using a Kalman filter to obtain the product of the airbag inflation curve and the device volume change curve. S4. Establish an intelligent monitoring module The X-axis represents time (patient's movement state), and the Y-axis is divided into three parts, from top to bottom, representing vaginal pressure value, balloon inflation volume, and pelvic floor support intelligent equipment volume, forming a curve representing the patient's characteristics; then, this curve is used as a grayscale image, the size of the curve is adjusted, and it is converted into a two-dimensional matrix; finally, the patient's grayscale curve is converted into a characteristic color image. Data feature color images of ≥1000 patients are obtained in the above manner. All the obtained feature color images are input into DCGAN for training to obtain AI model and establish intelligent monitoring module. When the patient uses this equipment for treatment again, feature color images are obtained based on the curve of the patient's characteristics. The feature color images are matched with AI model. By matching the vaginal wall pressure value of the patient in different movement states, the micro air pump controlled by MCU is used to inflate / depressurize the ring airbag.

[0012] Preferably, the clinical characteristics include the patient's age, height, weight, and prolapse grade; the sampling frequency of the pressure sensing electrode is 2-10Hz.

[0013] The advantages of this invention are: (1) Based on the feedback data from the pressure sensor, the present invention can autonomously adjust the shape of the pessary, and at the same time facilitate researchers to integrate clinical data, establish a causal relationship model between clinical data and treatment results, and develop an intelligent treatment system.

[0014] (2) The present invention is an artificial intelligence wearable device that can change size and is used for non-surgical treatment of pelvic organ prolapse diseases and for pelvic floor support. It can precisely adjust the size, shape and support strength of the uterine pessary according to the degree of uterine prolapse, the physiological structure of the vagina and individual differences of different patients.

[0015] (3) This invention uses pressure sensors and other methods to monitor the contact pressure between the pessary and the tissue in real time to determine the fit of the pessary. By analyzing the monitoring data, patients can use an APP to adjust the size of the pessary, which also facilitates precise individualized treatment such as biofeedback; it can extend the service life of the pessary and reduce the cost of traditional outpatient pessary trial fitting; the size can be quickly changed through the APP, making it easy to place and remove, and because of its real-time monitoring, it can avoid the displacement of traditional pessaries; elderly patients or those with limited mobility do not need to frequently visit the hospital for follow-up examinations through the intelligent diagnosis and treatment system, and can complete data feedback through the APP or home terminal, reducing the difficulty of medical treatment; it establishes an intelligent diagnosis and treatment system that integrates clinical data and causal models, and constructs a chronic disease management ecosystem for pelvic floor dysfunction. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of the present invention after inflation.

[0017] Figure 2 This is a schematic diagram of the structure of the present invention after the protective film has been applied.

[0018] Figure 3 This is a schematic diagram of the structure before inflation of the present invention. Figure 1 .

[0019] Figure 4 This is a schematic diagram of the structure before inflation of the present invention. Figure 2 .

[0020] Figure 5 This is a schematic diagram of the internal structure of part of the present invention.

[0021] Figure 6 This is a schematic diagram of the structure of the miniature air pump of the present invention.

[0022] The meanings of the symbols in the diagram are as follows: 1-Main body, 2-Second airbag, 3-Pressure sensing electrode, 4-First airbag, 5-Cavity, 6-Miniature air pump, 7-Pull cord, 8-Sheath, 9-Battery, 10-Charging port. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0024] like Figure 1-6 As shown, a wearable capsule-shaped smart support for pelvic organ prolapse and its application include a body 1. The body 1 consists of a central chamber 5, a first airbag 4 surrounding the outer periphery of the chamber 5, and two second airbags 2. The chamber 5 is hollow and square, with a length of 30 mm, a width, and a height of 20 mm. The first airbag 4, when inflated, forms a ring around the outer periphery of the chamber 5 along its length. The second airbags 2, when inflated, form a hemispherical shape. The two second airbags 2 are respectively positioned at the two ends of the chamber 5, resulting in an elliptical shape for the entire uterine support after inflation. The maximum length of the body 1 after inflation is 70 mm, and the maximum diameter after inflation is 50 mm, making it suitable for different individuals and optimizing the design of the uterine support, thus reducing friction and irritation to the vagina and surrounding tissues.

[0025] Specifically, the chamber 5 is equipped with a pressure sensor and three miniature air pumps 6. The air outlets of the three miniature air pumps 6 are connected to the first airbag 4 and the two second airbags 2, respectively, so that the miniature air pumps 6 can inflate and deflate the airbags.

[0026] Furthermore, the main body 1 is equipped with a pull cord 7 and a charging port 10 for easy removal of the main body 1. The pull cord 7 contains an air pump tube for a miniature air pump 6. A pressure-sensing electrode 3 is installed at the end of the second airbag 2 for treating the patient. Additionally, the main body 1 can be covered with a disposable sleeve 8 during use to keep it clean, eliminating the need for washing.

[0027] Furthermore, the pressure sensor, miniature air pump 6, and pressure sensing electrode 3 are all connected to the main control processing module, software, and battery 9 via the terminal. The main body 1, by employing smart materials or microelectromechanical systems (MEMS) technology, can sense real-time pressure changes in the uterus and vagina and automatically adjust to the optimal support state to ensure effective support for the uterus while avoiding excessive pressure on surrounding tissues. Additionally, sensors can be used to collect physiological data, such as pressure and displacement information, and corresponding control algorithms can be developed to analyze and process the sensor data, thereby accurately driving the adaptive mechanism to make adjustments. Moreover, the main body 1 can employ efficient miniature batteries or wireless charging technology to ensure stable operation during prolonged use.

[0028] The device itself is made of medical-grade materials, ensuring biocompatibility and preventing adverse reactions such as allergies and inflammation. It also ensures patient comfort during wear, without disrupting daily life or activities. Furthermore, the device can collect data, facilitating the integration of multi-source data by researchers. This allows for the later application of causal graph models, structural equation modeling, and other methods to establish causal relationship models between the shape, pressure, and volume of the pessary and treatment outcomes. Through data analysis, theoretical reasoning, and expert opinions, the causal pathways and interaction mechanisms between variables can be determined. For example, it can analyze how age and reproductive history affect pelvic muscle strength and hormone levels, leading to uterine prolapse, and the causal impact of different treatment methods (such as pessary treatment and surgical treatment) on disease outcomes.

[0029] Running the mobile app program for the smart pelvic floor support device triggers the operation of the miniature air pump 6 and pressure sensor via the Bluetooth / WiFi information module inside the device and the mobile phone, inflating the three airbags and making the device elliptical in shape, thus providing extended support for the pelvic floor within the vagina.

[0030] The application of a wearable capsule-shaped smart support device for pelvic organ prolapse includes the following specific steps: S1. Determine the basic data range of the pelvic floor support intelligent equipment. Input the patient’s clinical characteristics into the database system to obtain the basic data range of surface pressure of the pelvic floor support intelligent equipment; S2, Intelligent Equipment for Pelvic Floor Support: Data Acquisition and Mobile App Interactive Control The basic shape-pressure data is transmitted through the information transmission module between the main control processing module and the patient's mobile APP. The main control processing module performs initial inflation based on the basic data sent out; the pressure sensor electrode 3 collects the pressure change data on the surface of the equipment in real time and sends it to the main control processing module. The information transmission module between the main control processing module and the patient's mobile APP is used to upload the data to the patient's mobile APP, so that the patient can dynamically change the shape and size of the pelvic floor support smart equipment by adjusting the inflation volume in the airbag through the mobile APP, thereby achieving precise individualized treatment capabilities. S3. Post-processing of collected data on mobile phones The pressure sensing electrode pads 3 on both sides of the device collect the pressure change values ​​of the vaginal wall from a patient's sitting position to standing position, walking position, and running position in a continuous state. The data is uploaded through the information transmission module and processed using a Kalman filter to obtain the vaginal pressure change curve. While the patient changes their movement state, they can adjust the inflation and shape of the device through the APP, record the inflation volume (inflation is positive, deflation is negative), and calculate the real-time device volume. The data is then processed using a Kalman filter to obtain the product of the airbag inflation curve and the device volume change curve. S4. Establish an intelligent monitoring module The X-axis represents time (patient's movement state), and the Y-axis is divided into three parts, from top to bottom, representing vaginal pressure value, balloon inflation volume, and pelvic floor support intelligent equipment volume, forming a curve representing the patient's characteristics; then, this curve is used as a grayscale image, the size of the curve is adjusted, and it is converted into a two-dimensional matrix; finally, the patient's grayscale curve is converted into a characteristic color image. Data feature color images of ≥1000 patients are obtained in the above manner. All the obtained feature color images are input into DCGAN for training to obtain AI model and establish intelligent monitoring module. When the patient uses this equipment for treatment again, feature color images are obtained based on the curve of the patient's characteristics. The feature color images are matched with AI model. By matching the vaginal wall pressure value of the patient in different movement states, the micro air pump controlled by MCU is used to inflate / depressurize the ring airbag.

[0031] The above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A wearable capsule-shaped smart support for pelvic organ prolapse, characterized in that, The equipment includes a main body (1), which has a hollow square chamber (5) inside. A first airbag (4) is provided around the outer periphery of the chamber (5) in the length direction. A second airbag (2) is provided at both ends of the chamber (5) in the shape of a hemisphere after inflation. The main body (1) is elliptical after inflation. Pressure sensing electrode plates (3) are installed at the ends of the second airbag (2). The chamber (5) is connected to the first airbag (4) and the second airbag (2).

2. The wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 1, characterized in that: The length of the chamber (5) is 30 mm, and the width and height of the chamber (5) are both 20 mm.

3. A wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 1, characterized in that: The length of the body (1) after inflation is 70mm and the diameter after inflation is 50mm.

4. A wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 1, characterized in that: A miniature air pump (6) is installed in the chamber (5), and the air outlet of the miniature air pump (6) is connected to the first airbag (4) and the second airbag (2) respectively.

5. A wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 1, characterized in that: The main body (1) is also provided with a pull rope (7) and a charging port (10), and the pull rope (7) contains the air pump conduit of a miniature air pump (6).

6. A wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 1, characterized in that: The main body (1) is also covered with a disposable film (8).

7. A wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 5, characterized in that: The main body (1) is also equipped with an information transmission module. The information transmission module, pressure sensor, micro air pump (6) and pressure sensing electrode (3) are all connected to the software terminal and battery (9) through the main control processing module.

8. A wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 7, characterized in that: The information transmission module is either a Bluetooth information transmission module or a WiFi information transmission module.

9. An application of a wearable capsule-shaped intelligent support device for pelvic organ prolapse as described in any one of claims 1-8, characterized in that, The specific steps are as follows: S1. Determine the basic data range of the pelvic floor support intelligent equipment. Input the patient’s clinical characteristics into the database system to obtain the basic data range of surface pressure of the pelvic floor support intelligent equipment; S2, Intelligent Equipment for Pelvic Floor Support: Data Acquisition and Mobile App Interactive Control The basic shape-pressure data is transmitted through the information transmission module between the main control processing module and the patient's mobile APP. The main control processing module performs initial inflation based on the basic data sent out; it collects the pressure change data on the surface of the equipment in real time through the pressure sensing electrode (3), sends it to the main control processing module, and uploads it to the patient's mobile phone APP using the information transmission module between the main control processing module and the patient's mobile phone APP. S3. Post-processing of collected data on mobile phones The pressure sensing electrode pads (3) on both sides of the device collect the pressure change value of the vaginal wall from sitting to standing to walking to running in a continuous state. The data is uploaded through the information transmission module and processed by the Kalman filter to obtain the vaginal pressure change curve. When the patient changes the movement state, the device is inflated and shaped through the APP. The inflation volume is recorded and the real-time device volume is calculated. The data is processed by the Kalman filter to obtain the airbag inflation change curve and the device volume change curve. S4. Establish an intelligent monitoring module Using the X-axis to represent time and the Y-axis to be divided into three parts, from top to bottom, representing vaginal pressure value, balloon inflation volume, and pelvic floor support intelligent equipment volume, a curve representing the patient's characteristics is formed; then this curve is used as a grayscale image, the size of the curve is adjusted, and it is converted into a two-dimensional matrix; the patient's grayscale curve is then converted into a characteristic color image; Data feature color images of ≥1000 patients are obtained in the above manner. All the obtained feature color images are input into DCGAN for training to obtain AI model and establish intelligent monitoring module. When the patient uses this equipment for treatment again, feature color images are obtained based on the curve of the patient's characteristics. The feature color images are matched with AI model. By matching the vaginal wall pressure value of the patient in different movement states, the micro air pump controlled by MCU is used to inflate / depressurize the ring airbag.

10. The application of the wearable capsule-shaped intelligent support device for pelvic organ prolapse according to claim 9, characterized in that: Clinical features include patient age, height, weight and prolapse grade; the sampling frequency of the pressure sensing electrode (3) is 2-10 Hz.

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