A system for direct detection of pelvic floor muscle strength mimicking a vaginal examination

Abstract

The application discloses a kind of pelvic floor muscle muscle strength direct detection system of simulated vaginal examination, comprising: detection glove, index finger position is integrated with flexible pressure sensing component, the thin film pressure sensor of the folding angle bending structure of independent wiring of multiple sensing points is used, for collecting the pressure signal of pelvic floor muscle muscle strength;Data receiving module is connected with detection glove, for receiving the detection result of the thin film pressure sensor of detection glove;Display analysis unit is connected with data receiving module, for displaying and analyzing detection result.The pelvic floor muscle muscle strength direct detection system of simulated vaginal examination of the application, flexible pressure sensing component is the thin film pressure sensor of the folding angle bending structure of independent wiring of multiple sensing points, after forming, can be fitted human back curved surface, guarantee sensing surface and skin fully close, avoid local suspension, guarantee pressure signal acquisition uniform and stable, simultaneously, the way of simulated vaginal examination, directly test corresponding pelvic floor muscle tension and the numerical value of muscle strength.

Description

Technical Field

[0001] This invention relates to the field of pelvic floor muscle testing technology, and more specifically, to a direct pelvic floor muscle strength testing system that simulates a vaginal digital examination. Background Technology

[0002] Pelvic floor dysfunction (PFD) is a common condition affecting women's quality of life, including urinary incontinence, pelvic organ prolapse, female sexual dysfunction, and fecal incontinence. Domestic and international research data confirm that pregnancy and childbirth are the leading risk factor for PFD in women. Therefore, timely pelvic floor muscle repair during the postpartum period is crucial for reducing the incidence of PFD and saving on medical treatment costs.

[0003] Postpartum pelvic floor rehabilitation has been developing in China for several years and is gradually becoming a routine postpartum screening procedure. However, most pelvic floor muscle testing equipment currently used clinically is indirect, such as vaginal pressure probe testing and pelvic floor muscle electromyography (EMG). These methods cannot eliminate the interference of other muscles (such as abdominal, gluteal, and adductor muscles) on the pressure during pelvic floor muscle contraction, and clinicians cannot extract pure pelvic floor muscle contraction values ​​from the data. Furthermore, the current clinical "gold standard" for pelvic floor muscle testing—digital vaginal examination—is highly subjective and yields crude results. Digital vaginal examination uses the Modified Oxford Muscle Strength Scale (MOS), with results ranging from 0 to 5, and does not include testing of pelvic floor muscle tone. Incomplete pelvic floor muscle testing will affect the clinical assessment process and treatment outcomes.

[0004] Therefore, there is an urgent need for a direct pelvic floor muscle strength detection system that simulates vaginal digital examination. Summary of the Invention

[0005] The purpose of this invention is to provide a direct pelvic floor muscle strength detection system that simulates vaginal digital examination, in order to solve the problems in the prior art. Through sensor design, pressure transmission mechanism and system integration scheme, it simulates the "gold standard" vaginal digital examination method to directly test the corresponding pelvic floor muscle tension and strength values, thereby achieving accurate and objective detection of pelvic floor muscle strength.

[0006] This invention provides a direct detection system for pelvic floor muscle strength that simulates vaginal digital examination, comprising: a testing glove, wherein a flexible pressure sensing component is integrated at the index finger position of the testing glove, and the flexible pressure sensing component adopts a thin-film pressure sensor with a multi-sensor point independent wiring and a bent structure for collecting pressure signals of pelvic floor muscle strength.

[0007] A data receiving module, connected to the testing glove, is used to receive the detection results of the thin-film pressure sensor of the testing glove;

[0008] The display and analysis unit, connected to the data receiving module, is used to display and analyze the detection results of the thin-film pressure sensor.

[0009] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the thin-film pressure sensor includes: a sensor base, a measuring protrusion provided at the middle position of the sensor base, and a reference plane provided around the periphery of the sensor base.

[0010] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the thin-film pressure sensor further includes: a pressure sensing area, conductive leads, and connecting terminals. The pressure sensing area is tightly fitted to the surface of the sensor base, and the connecting terminals are connected to the data receiving module. The pressure sensing area 1 is provided with multiple peripheral reference sensing points and a central measuring sensing point, and the height of the central measuring sensing point is higher than the height of each of the peripheral reference sensing points. The conductive leads are used to connect each of the peripheral reference sensing points and the central measuring sensing point to the connecting terminals.

[0011] Furthermore, the measuring protrusion is aligned vertically with the central measuring sensing point, and the peripheral reference sensing points are evenly spaced and distributed above the reference plane.

[0012] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the connecting terminal includes one common electrode, one measuring electrode, and multiple reference electrodes, and the number of reference electrodes is consistent with the number of peripheral reference sensing points. The electrodes are evenly distributed in the vertical direction, wherein the measuring electrode is located in the middle position, and the common electrode is located below the measuring electrode; a semi-circular incision is provided in the upper half of the central measuring sensing point, and the arc surface of the semi-circular incision is located at the end away from the connecting terminal.

[0013] The common electrode is connected to the central measurement sensing point and each of the peripheral reference sensing points respectively; each of the peripheral reference sensing points is connected to the corresponding reference electrode in a top-to-bottom order via independent conductive leads, ensuring that no wires cross the sensing electrode surface; the central measurement sensing point is connected to the measurement electrode via an independent conductive lead.

[0014] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the surfaces of each of the peripheral reference sensing points and the central measuring sensing point are soft rubber contacts; each of the soft rubber contacts has an arc-shaped protrusion structure, and each of the soft rubber contacts is bonded to each of the peripheral reference sensing points and the central measuring sensing point using medical neutral silicone, flexible medical PU adhesive, or UV adhesive; or, each of the soft rubber contacts is integrally formed with each of the peripheral reference sensing points and the central measuring sensing point.

[0015] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the integration of the flexible pressure sensing component with the index finger position of the detection glove includes: injection encapsulation, thermoforming encapsulation, or sewing wrapping encapsulation, wherein:

[0016] The encapsulation process includes: positioning the thin-film sensor within a groove in the detection glove, and then injecting liquid transparent silicone that cures at room temperature.

[0017] The hot-press encapsulation includes: laminating PU hot melt adhesive films above and below the thin-film sensor, and then fusing them with the fabric of the testing glove through high-temperature hot pressing;

[0018] The sewing and packaging process includes wrapping the thin-film sensor with a thin non-woven fabric and then sewing it to the corresponding position on the detection glove.

[0019] In the pelvic floor muscle strength direct detection system for simulated vaginal digital examination as described above, preferably, the data receiving module is connected to the detection glove via a magnetic connector or a straight connector.

[0020] The top of the data receiving module is provided with a magnetic connector, which has a recessed groove structure and multiple spring contacts distributed on its surface. The magnetic connector is connected to the magnetic connector to realize the connection between the data receiving module and the testing glove.

[0021] The data receiving module has a quick-connect port on one side, and the straight connector is inserted into the quick-connect port to connect the data receiving module with the testing glove.

[0022] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, a circuit board, a rechargeable battery, and a wireless charging coil are arranged from top to bottom in the middle position inside the data receiving module.

[0023] The circuit board is equipped with a signal amplification unit, a filtering unit, and an AD conversion unit, wherein:

[0024] The signal amplification unit is used to amplify the collected pressure signal;

[0025] The filtering unit is used to filter the amplified pressure signal;

[0026] The AD conversion unit is used to perform AD conversion processing on the filtered pressure signal.

[0027] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the data receiving module is fixed to the wrist via an arched memory elastic wristband or a flexible wristband, wherein:

[0028] The data receiving module further includes: magnetic snap-fit ​​slots symmetrically formed at both ends of the bottom of the data receiving module, with a first magnet embedded at both ends of the inner wall of each magnetic snap-fit ​​slot.

[0029] The arched memory elastic wristband includes: a long strip of memory elastic sheet, the two ends of which are pre-pressed into an arc-shaped structure with a central arch; a wristband support platform is provided in the middle of the memory elastic sheet; positioning blocks are symmetrically arranged on the upper surface of the wristband support platform, each positioning block matching the shape of the corresponding magnetic buckle slot, and the line connecting two positioning blocks is perpendicular to the axis of the memory elastic sheet; a second magnet is embedded at both ends inside each positioning block, the position of each second magnet corresponding to the position of the corresponding first magnet, and the polarity of the second magnet is opposite to that of the first magnet; the memory elastic sheet and the wristband support platform are also covered with a fully enclosed flexible sheath; the magnetic buckle slot of the data receiving module and the positioning block of the arched memory elastic wristband are concave and convex to achieve precise positioning; the first magnet of the data receiving module and the second magnet of the arched memory elastic wristband are attracted by opposite poles, so that the data receiving module is quickly and firmly fixed on the wristband support platform;

[0030] And / or, the data receiving module further includes strap slots formed on both sides of the data receiving module, and the strap slots on both sides are connected to each other. The flexible wristband is inserted into the strap slots, and the flexible wristband is provided with an adjustable buckle to adapt to different wrist sizes by adjusting the buckle.

[0031] In the pelvic floor muscle strength direct detection system simulating vaginal digital examination as described above, preferably, the display and analysis unit includes a pelvic floor muscle display system and a pelvic floor muscle database.

[0032] This invention provides a pelvic floor muscle strength direct detection system simulating vaginal digital rectal examination. The flexible pressure sensing component employs a thin-film pressure sensor with a bent-angle structure and multiple independently routed sensing points. After molding, it conforms to the curved surface of the back of the hand, ensuring a tight fit between the sensing surface and the skin, avoiding local suspension, and guaranteeing uniform and stable pressure signal acquisition. Simultaneously, it simulates the "gold standard" vaginal digital rectal examination, directly testing the corresponding pelvic floor muscle tension and strength values, making it more clinically operable and assisting in the diagnosis and treatment of pelvic floor dysfunction, forming a more rigorous and scientific diagnostic and treatment standard. The multi-sensor point independent routing layout: the central measuring sensing point and surrounding reference sensing points have independent routing, with a common electrode connecting all sensing points, and the remaining sensing points having separate routing. No wires cross the sensing electrode surface, avoiding local stress concentration and ensuring accurate and stable pressure data acquisition. The arc-shaped soft rubber contact conduction: all sensing points are equipped with arc-shaped soft rubber contacts, which, when external pressure... When applied to the curved top surface, the pressure is evenly concentrated and transmitted to the sensing area below, avoiding force point displacement and improving detection accuracy. Through the use of angled and bent sensors, independent wiring layout, and soft rubber contact conduction design, interference from other muscles is effectively eliminated, enabling precise and direct detection of pelvic floor muscle strength. It can also detect pelvic floor muscle tension, effectively improving the accuracy and stability of pelvic floor muscle strength detection and providing a more reliable basis for clinical diagnosis. Diverse packaging processes are available: injection, thermoforming, and sewing are offered to meet different clinical needs and production scenarios. Magnetic / quick-plug connections between the testing gloves and data receiving module, along with a wristband fixation solution, enhance the convenience and comfort of clinical operation. Digital detection results avoid the subjective influence of traditional finger examinations, providing objective and accurate evidence for clinical evaluation. The complete detection system integrates signal acquisition, processing, transmission, analysis, and report generation, improving clinical work efficiency. Attached Figure Description

[0033] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described below with reference to the accompanying drawings, wherein:

[0034] Figure 1 This is an overall schematic diagram of an embodiment of the pelvic floor muscle strength direct detection system for simulating vaginal digital examination provided by the present invention;

[0035] Figure 2 This is a schematic diagram of the overall structure of the thin-film sensor;

[0036] Figure 3 This is a schematic diagram of the overall structure of the connecting terminals;

[0037] Figure 4 This is a schematic diagram of the structure of a soft rubber contact.

[0038] Figure 5 This is a schematic diagram of the three-dimensional structure of the sensor base;

[0039] Figure 6 This is the front view of the sensor base;

[0040] Figure 7 This is a top view of the sensor base;

[0041] Figure 8 A perspective view of the back of the hand in a right-hand inspection glove;

[0042] Figure 9 A perspective view of the palm side of a right-hand inspection glove;

[0043] Figure 10 A schematic diagram of the overall side structure of the glove being inspected;

[0044] Figure 11 An exploded view of the entire glove for inspection;

[0045] Figures 12-13 A three-dimensional structural diagram of the data receiving module from different angles;

[0046] Figure 14 This is a top view of the data receiving module;

[0047] Figure 15 for Figure 14 Sectional view along axis AA;

[0048] Figure 16 This is a diagram illustrating the straightened state of the flexible wristband.

[0049] Figure 17 This is a schematic diagram of the flexible wristband in its curled state.

[0050] Figure 18 This is a schematic diagram showing the connection between the flexible wristband and the data receiving module;

[0051] Figure 19 This is a schematic diagram of the connection process of the magnetic connector;

[0052] Figures 20-21 This is a schematic diagram showing the connection between the data receiving module and the conductive leads.

[0053] Figure 22 This is a schematic diagram of the flexible wristband structure;

[0054] Figures 23-25 A schematic diagram of the overall system for directly detecting pelvic floor muscle strength.

[0055] Figure 26 A schematic diagram of the operation of the pelvic floor muscle strength direct detection system;

[0056] Figure 27 A flowchart illustrating the process of a direct pelvic floor muscle strength detection system is shown.

[0057] Figure labeling: 1-Pressure sensing area, 101-Peripheral reference sensing point, 102-Central measuring sensing point, 103-Semi-circular notch, 104-Soft rubber contact, 105-Sensor base, 1051-Measuring protrusion, 1052-Reference plane, 2-Conductive lead, 3-Connecting terminal, 301-Common electrode, 302-Measuring electrode, 303-Reference electrode, 304-Direct connector, 305-Magnetic connector, 4-Detection glove, 401-Index finger position, 5-Data Receiver module, 501-Quick connector, 502-Strap slot, 503-Flexible wristband, 504-Magnetic connector, 505-Magnetic buckle slot, 5051-First magnet, 506-Circuit board, 507-Rechargeable battery, 508-Wireless charging coil, 6-Arched memory elastic wristband, 601-Memory spring, 602-Wristband support platform, 603-Positioning block, 604-Second magnet, 605-Arc-shaped structure, 7-Pelvic floor muscle display system, 8-Pelvic floor muscle database. Detailed Implementation

[0058] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. The descriptions of the exemplary embodiments are merely illustrative and are in no way intended to limit the present disclosure or its application or use. The present disclosure may be implemented in many different forms and is not limited to the embodiments described herein. These embodiments are provided so that the present disclosure will be thorough and complete, and will fully express the scope of the disclosure to those skilled in the art. It should be noted that, unless specifically stated otherwise, the relative arrangement of components and steps, the composition of materials, numerical expressions, and values ​​set forth in these embodiments should be interpreted as exemplary only and not as limiting.

[0059] The terms “first,” “second,” and similar terms used in this disclosure do not indicate any order, quantity, or importance, but are merely used to distinguish different parts. Terms such as “including” or “contains” mean that the element preceding the term encompasses the element listed after it, and do not exclude the possibility of encompassing other elements as well. Terms such as “above” and “below” are used only to indicate relative positional relationships; when the absolute position of the described object changes, this relative positional relationship may also change accordingly.

[0060] In this disclosure, when a specific component is described as being located between a first component and a second component, an intermediary component may or may not be present between the specific component and the first or second component. When a specific component is described as connecting to other components, the specific component may be directly connected to the other components without having an intermediary component, or it may not be directly connected to the other components but may have an intermediary component.

[0061] All terms used in this disclosure (including technical or scientific terms) have the same meaning as understood by one of ordinary skill in the art to which this disclosure pertains, unless otherwise specifically defined. It should also be understood that terms defined in a general dictionary, such as a dictionary, should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and not as having an idealized or highly formalized meaning, unless expressly defined herein.

[0062] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, they should be considered part of the specification.

[0063] like Figures 1-26 As shown, the pelvic floor muscle strength direct detection system for simulating vaginal digital examination provided in this embodiment includes:

[0064] The testing glove 4 has a flexible pressure sensing component integrated at the index finger position 401. The flexible pressure sensing component is a thin-film pressure sensor with a multi-sensor point independent wiring and a bent structure, which is used to collect the pressure signal 104 of the pelvic floor muscle strength.

[0065] The data receiving module 5 is connected to the testing glove 4 and is used to receive the detection results of the thin film pressure sensor of the testing glove 4;

[0066] The display and analysis unit is connected to the data receiving module 5 and is used to display and analyze the detection results of the thin-film pressure sensor.

[0067] Among them, the testing glove 4 and the membrane pressure sensor are integrated components and can be aseptically packaged as disposable consumables; the data receiving module 5 is a reusable device that can be wirelessly charged and wirelessly transmit data via Bluetooth.

[0068] Furthermore, the thin-film pressure sensor has a bent and angled structure, which, after molding, can conform to the curved surface of the back of the human hand, ensuring that the sensing surface is fully and tightly attached to the skin, avoiding local suspension, and ensuring uniform and stable pressure signal acquisition. Figures 5-7 As shown, the thin-film pressure sensor includes a sensor base 105, a measuring protrusion 1051 at its center, and a reference plane 1052 around its periphery. The sensor base 105 is made of stainless steel, titanium alloy, or PEEK hard material to ensure it does not deform under stress during detection. As the sensor's measuring reference component, it must also maintain high surface flatness and roughness. Furthermore, the measuring protrusion 1051 in the center of the base is higher than the surrounding reference plane 1052; through calibration of the reference pressure value, the precise value of muscle force can be detected.

[0069] Furthermore, such as Figure 1 As shown, the thin-film pressure sensor further includes: a pressure sensing area 1, a conductive lead 2, and a connecting terminal 3. The pressure sensing area 1 is tightly attached to the surface of the sensor base 105, and the connecting terminal 3 is connected to the data receiving module 5, as shown. Figure 2 As shown, the pressure sensing area 1 is provided with multiple peripheral reference sensing points 101 and a central measuring sensing point 102, and the height of the central measuring sensing point 102 is higher than the height of each of the peripheral reference sensing points 101. This raised design can more accurately capture the pressure signal generated when the pelvic floor muscles contract. At the same time, the peripheral reference sensing points 101 can collect reference pressure values, and through calibration, the interference of other muscles can be eliminated to achieve differentiated pressure detection. The conductive lead 2 is used to connect each of the peripheral reference sensing points 101 and the central measuring sensing point 102 to the connecting terminal 3.

[0070] Furthermore, the measuring protrusion 1051 is aligned vertically with the central measuring sensing point 102, and the peripheral reference sensing points 101 are evenly spaced above the reference plane 1052.

[0071] Furthermore, such as Figure 3 As shown, the connection terminal 3 includes one common electrode 301, one measuring electrode 302, and multiple reference electrodes 303 (e.g., three). The number of reference electrodes is consistent with the number of peripheral reference sensing points. The electrodes are evenly distributed vertically, with the measuring electrode 302 located in the center and the common electrode 301 located below it. Figure 2 As shown, a semi-circular notch 103 is provided in the upper half of the central measuring sensing point 102. The arc surface of the semi-circular notch 103 is located at the end away from the connecting terminal 3. Furthermore, the height of the semi-circular notch 103 is higher than the height of the central measuring sensing point 102, so that there are no wire crossings in the upper half of the central measuring sensing point 102, avoiding local stress concentration caused by wire protrusion, ensuring uniform force in the sensing area, and ensuring accurate and stable pressure acquisition data.

[0072] The common electrode 301 is connected to the central measuring sensing point 102 and each of the peripheral reference sensing points 101. Each peripheral reference sensing point 101 is connected to the corresponding reference electrode 303 via an independent conductive lead 2 arranged from top to bottom, ensuring that no wires cross the sensing electrode surface. The central measuring sensing point 102 is connected to the measuring electrode 302 via an independent conductive lead 2. The electrode wiring layout of this invention is optimized, with the common electrode 301 connecting all sensing points and the remaining sensing points having separate wiring, preventing wires from crossing the sensing electrode surface, avoiding local stress concentration, and ensuring accurate and stable pressure acquisition data.

[0073] like Figure 11 As shown, the surfaces of each of the peripheral reference sensing points 101 and the central measuring sensing point 102 are soft rubber contacts 104; as Figure 4 As shown, each of the soft rubber contacts 104 has an arc-shaped protrusion structure with the semi-circular arch facing downwards and the flat bottom edge conforming to all the sensing points of the thin-film pressure sensor. In this way, when external pressure is applied to the arc-shaped top surface of the soft rubber contact 104, the pressure is uniformly concentrated and transmitted to the sensing area below. The design of the semi-circular cutout 103 further optimizes the force distribution, avoids the displacement of the force point, and improves the detection accuracy. Each of the soft rubber contacts 104 is bonded to each of the peripheral reference sensing points 101 and the central measuring sensing point 102 using medical neutral silicone, flexible medical PU adhesive, or UV adhesive. Alternatively, each of the soft rubber contacts 104 is integrally formed with each of the peripheral reference sensing points 101 and the central measuring sensing point 102. Figures 8-11 The diagram shows the overall structure of the detection glove. The bending structure of the thin-film sensor can bend the conductive lead 2 to the back of the hand, which is beneficial for the connection of the terminal 3 and the data receiving module 5. The soft rubber contact 104 serves as a conductive element of the flexible pressure sensing component, transmitting muscle force to the electrode of the terminal 3, thereby enabling stable and accurate transmission of pressure data.

[0074] Furthermore, the integration of the flexible pressure sensing component with the index finger position 401 of the detection glove 4 includes: potting encapsulation, thermoforming encapsulation, or sewing wrapping encapsulation, wherein:

[0075] The encapsulation process includes: positioning the thin-film sensor in the groove of the detection glove 4, and injecting liquid transparent silicone for room temperature curing. In a specific implementation, the sensor base 105, the thin-film sensor, and the soft silicone contact 104 can be firmly fixed with soft glue or double-sided tape first. Then, the thin-film sensor is positioned in the groove of the glove mold, and liquid transparent silicone is injected. After room temperature curing, the sensor is completely encapsulated and sealed to prevent water and sweat corrosion.

[0076] The hot-press encapsulation includes: laminating PU hot melt adhesive films above and below the thin-film sensor, and fusing them with the fabric of the detection glove 4 through high-temperature hot pressing. In a specific implementation, a hot press can be used to laminate a layer of PU hot melt adhesive film above and below the thin-film sensor. After high-temperature heating, the PU hot melt adhesive film and the glove fabric are hot-pressed and fused together as one, resulting in a thin and light overall material that is resistant to repeated bending, waterproof, and does not detach.

[0077] The sewing and packaging process includes: wrapping the thin film sensor with a thin non-woven fabric and sewing it to the corresponding position on the detection glove 4. In a specific implementation, the thin film sensor can be completely wrapped with a thin non-woven fabric first, and then the fabric can be sewn to the palm / back of the glove with needle and thread. This method avoids high temperatures and damages the flexible circuit, but the thickness is relatively large and the sewing thread can easily generate local pressure that interferes with the detection data.

[0078] Furthermore, the data receiving module 5 is connected to the testing glove 4 via a magnetic connector 305 or a straight connector 304;

[0079] like Figure 12 As shown, the top of the data receiving module 5 is provided with a magnetic connector 504. The magnetic connector 504 has a recessed groove structure, and multiple spring contacts are distributed on the surface of the magnetic connector 504; as shown Figure 19 As shown, the magnetic connector 305 is connected to the magnetic connector female 504 to realize the connection between the data receiving module 5 and the testing glove 4. The sinking groove structure achieves a stable connection, avoids pulling the magnetic connector 305 in the direction of the back of the hand, prevents the wiring from breaking, and improves the convenience and reliability of clinical use.

[0080] like Figure 20 and Figure 21 As shown, a quick-connect port 501 is provided on one side of the data receiving module 5. The straight connector 304 is inserted into the quick-connect port 501 to connect the data receiving module 5 with the testing glove 4. The straight connector 304 cooperates with the quick-connect port 501 to achieve a quick connection between the testing glove 4 and the data receiving module 5, which is convenient for clinical operation.

[0081] Furthermore, such as Figure 15 As shown, the data receiving module 5 also has a circuit board 506, a rechargeable battery 507 and a wireless charging coil 508 arranged from top to bottom in the middle position inside, which has wireless charging function and realizes wireless data transmission through Bluetooth.

[0082] The circuit board 506 is equipped with a signal amplification unit, a filtering unit, and an AD conversion unit, wherein:

[0083] The signal amplification unit is used to amplify the collected pressure signal;

[0084] The filtering unit is used to filter the amplified pressure signal;

[0085] The AD conversion unit is used to perform AD conversion processing on the filtered pressure signal.

[0086] Furthermore, the data receiving module 5 is fixed to the wrist via an arched memory elastic wristband 6 or a flexible wristband 503. In one embodiment of the invention, the arched memory elastic wristband 6 is made of a high-elasticity manganese steel thin strip, the cross-section of which is pre-pressed into an arc shape with a central arch. When straightened, the arch surface is taut, maintaining a straight strip; when subjected to a slapping impact, the arched structure instantly becomes unstable and automatically curls inward, firmly gripping the wrist. The two ends of the steel strip are rounded to prevent cutting the skin.

[0087] Specifically, in one embodiment of the present invention, such as Figure 13 As shown, the data receiving module 5 further includes: magnetic snap-fit ​​slots 505 symmetrically opened at both ends of the bottom of the data receiving module 5, and a first magnet 5051 is embedded at both ends of the inner wall of each magnetic snap-fit ​​slot 505. The magnetic snap-fit ​​slots 505 are used for positioning and cooperating with external components, and the first magnets 5051 are used to generate magnetic attraction and fixing force.

[0088] like Figure 16 As shown, the arched memory elastic wristband 6 includes: a long strip of memory spring 601, the two ends of which are pre-pressed into an arc-shaped structure 605 with a central arch; a wristband support platform 602 is provided in the middle of the memory spring 601; positioning blocks 603 are symmetrically arranged on the upper surface of the wristband support platform 602, each positioning block 603 matching the shape of the corresponding magnetic buckle slot 505 for precise positioning, and the line connecting two positioning blocks 603 is perpendicular to the axial direction of the memory spring 601; a second magnet 604 is embedded at both ends of the interior of each positioning block 603, the position of each second magnet 604 corresponding to the position of the corresponding first magnet 5051, and the polarity of the second magnet 604 is opposite to that of the first magnet 5051; the memory spring 601 and the wristband support platform 602 are also covered with a fully enclosed flexible sheath; as shown Figure 17As shown, the magnetic snap-on slot 505 of the data receiving module 5 engages with the positioning block 603 of the arched memory elastic wristband 6 to achieve precise positioning. The first magnet 5051 of the data receiving module 5 and the second magnet 604 of the arched memory elastic wristband 6 attract each other with opposite poles, generating a fixing force, so that the data receiving module 5 is quickly and firmly fixed on the wristband support platform 602, achieving rapid positioning and fixation; during disassembly, the data receiving module 5 can be separated by pulling it upwards. The wristband support platform 602 and the memory spring 601 are configured to cooperate, and the two can be an integral structure or a separate structure. In the embodiment of the integral structure, the wristband support platform 602 and the memory spring 601 can be completely wrapped and sealed with PVC soft plastic or knitted fabric, and the edges are sealed by high-frequency heat pressing. The steel sheet is completely sealed inside the PVC sheath, the edges are tightly sealed, there is no exposed metal, and it is safe and resistant to bending. In the embodiment of the separate structure, the memory spring 601 is embedded in the slot at the bottom of the wristband support platform 602 to form an integral wristband structure.

[0089] In another embodiment of the invention, such as Figure 20 As shown, the data receiving module 5 also includes strap slots 502 formed on both side walls of the data receiving module 5, and the strap slots 502 on both sides are interconnected, as shown. Figure 22 As shown, the flexible wristband 503 is threaded through the strap slot 502, and the flexible wristband 503 is provided with an adjustable buckle. By adjusting the buckle, it can adapt to different wrist sizes, improving wearing comfort and stability. For example, the flexible wristband 503 is made of elastic fabric material, which can effectively fix it to the wrist. It should be noted that the data receiving module 5 can simultaneously have a strap slot 502, a magnetic buckle slot 505, and a first magnet 5051. In specific implementations, users can choose to fix the data receiving module 5 to their wrist using either the arched memory elastic wristband 6 or the flexible wristband 503, according to their own habits.

[0090] Furthermore, such as Figure 26 As shown, the display and analysis unit includes a pelvic floor muscle display system 7 and a pelvic floor muscle database 8. The pelvic floor muscle display system 7 includes a real-time visualization module, a data storage and comparison module, and a report generation module.

[0091] The real-time visualization module is used to display the dynamic curve of pelvic floor muscle strength in real time, intuitively reflecting the contraction of pelvic floor muscles. Specifically, it can calculate the pelvic floor muscle strength level based on the calibrated pressure data and detect pelvic floor muscle tension.

[0092] The data storage and comparison module is used to automatically store the detection data into the pelvic floor muscle database 8, and call historical data for comparative analysis to evaluate changes in pelvic floor muscle function.

[0093] The report generation module is used to automatically generate assessment reports based on the test data, providing a basis for clinical diagnosis and rehabilitation treatment.

[0094] In practice, the operation of the pelvic floor muscle strength direct detection system includes pelvic floor muscle detection, data transmission to the pelvic floor muscle display system (7), and data storage to the pelvic floor muscle database (8), enabling real-time visualization, storage, and comparative analysis of the detection data. For example... Figure 27 As shown, the specific detection process includes steps such as signal acquisition, signal processing, wireless transmission, real-time visualization, data storage, data comparison, and report output, to achieve accurate and direct detection of pelvic floor muscle strength.

[0095] Specifically, the first step is for the doctor to wear the data receiving module 5 on their wrist, which can be fixed with an arched memory elastic wristband 6 or a flexible wristband 503, and adjusted to a comfortable position.

[0096] The second step is to connect the testing gloves 4 to the data receiving module 5 and wear them on the wrist;

[0097] Third, the doctor puts on testing gloves 4 and simulates a vaginal digital examination by inserting their index finger into the patient's vagina. The doctor then guides the patient to perform pelvic floor muscle contractions. The sensing area of ​​the thin-film sensor is located on the index finger side of the glove. The bending structure of the thin-film sensor allows the conductive lead 2 to bend to the back of the hand, facilitating the connection between the terminal 3 and the data receiving module 5. Figures 23-25 A schematic diagram of the overall system for directly detecting pelvic floor muscle strength is shown.

[0098] The fourth step is pressure signal acquisition: the flexible pressure sensing component acquires the pressure signal generated by the contraction of the pelvic floor muscles in real time. The central measuring sensing point 102 and the peripheral reference sensing point 101 respectively acquire pressure data. By calibrating the pressure value of the peripheral reference sensing point 101, the interference of other muscles is eliminated, and the pure pelvic floor muscle contraction value is obtained, so as to achieve accurate detection of pelvic floor muscle strength.

[0099] Step 5, signal processing and transmission: The data receiving module 5 amplifies, filters and performs AD conversion on the collected pressure signal, converting the analog signal into a digital signal. The processed digital signal is transmitted to the display and analysis unit via Bluetooth to display the dynamic curve of pelvic floor muscle strength in real time.

[0100] Step 6, Data Storage and Analysis: The display and analysis unit stores the test data to the pelvic floor muscle database 8, which can be compared and analyzed with historical data, and automatically generate test reports.

[0101] The pelvic floor muscle strength direct detection system simulating vaginal digital examination provided in this invention uses a flexible pressure sensing component with a thin-film pressure sensor featuring a multi-sensor point independently routed bendable structure. After molding, it conforms to the curved surface of the back of the hand, ensuring a tight fit between the sensing surface and the skin, avoiding local suspension, and guaranteeing uniform and stable pressure signal acquisition. Simultaneously, it simulates the "gold standard" vaginal digital examination, directly testing the corresponding pelvic floor muscle tension and strength values, making it more clinically operable and assisting in the diagnosis and treatment of pelvic floor dysfunction, forming a more rigorous and scientific diagnostic and treatment standard. The multi-sensor point independent route layout: the central measuring sensing point and surrounding reference sensing points have independent routes, a common electrode connects all sensing points, and the remaining sensing points have separate routes, with no wires crossing the sensing electrode surface, avoiding local stress concentration and ensuring accurate and stable pressure data acquisition. The arc-shaped soft rubber contact conduction: all sensing points are equipped with arc-shaped soft rubber contacts, so when external pressure... When force is applied to the curved top surface, the pressure is evenly concentrated and transmitted to the sensing area below, avoiding force point offset and improving detection accuracy. Through the use of angled and bent sensors, independent wiring layout, and soft rubber contact conduction design, interference from other muscles is effectively eliminated, enabling precise and direct detection of pelvic floor muscle strength. It can also detect pelvic floor muscle tension, effectively improving the accuracy and stability of pelvic floor muscle strength detection and providing a more reliable basis for clinical diagnosis. Diverse packaging processes are available: injection, thermoforming, and sewing are offered to meet different clinical needs and production scenarios. Magnetic / quick-plug connections between the testing gloves and data receiving module, along with a wristband fixation solution, enhance the convenience and comfort of clinical operation. Digital detection results avoid the subjective influence of traditional finger examinations, providing objective and accurate evidence for clinical evaluation. The complete detection system integrates signal acquisition, processing, transmission, analysis, and report generation, improving clinical work efficiency.

[0102] The embodiments of this disclosure have now been described in detail. To avoid obscuring the concept of this disclosure, some details known in the art have not been described. Those skilled in the art can fully understand how to implement the technical solutions disclosed herein based on the above description.

[0103] While specific embodiments of this disclosure have been described in detail by way of examples, those skilled in the art should understand that the examples are for illustrative purposes only and not intended to limit the scope of this disclosure. Those skilled in the art should understand that modifications can be made to the above embodiments or equivalent substitutions can be made to some technical features without departing from the scope and spirit of this disclosure. The scope of this disclosure is defined by the appended claims.

Claims

1. A system for directly detecting pelvic floor muscle strength by simulating digital vaginal examination, characterized in that, include: The testing glove has a flexible pressure sensing component integrated at the index finger position. The flexible pressure sensing component is a thin-film pressure sensor with a multi-sensor point independent wiring and a bent structure, which is used to collect pressure signals of pelvic floor muscle strength. A data receiving module, connected to the testing glove, is used to receive the detection results of the thin-film pressure sensor of the testing glove; The display and analysis unit, connected to the data receiving module, is used to display and analyze the detection results of the thin-film pressure sensor.

2. The pelvic floor muscle strength direct detection system based on simulated vaginal digital examination according to claim 1, characterized in that, The thin-film pressure sensor includes: a sensor base, a measuring protrusion at the center of the sensor base, and a reference plane around the periphery of the sensor base.

3. The pelvic floor muscle strength direct detection system based on simulated vaginal digital examination according to claim 2, characterized in that, The thin-film pressure sensor further includes: a pressure sensing area, conductive leads, and connecting terminals. The pressure sensing area is tightly attached to the surface of the sensor base. The connecting terminals are connected to the data receiving module. The pressure sensing area 1 is provided with multiple peripheral reference sensing points and a central measuring sensing point, and the height of the central measuring sensing point is higher than the height of each of the peripheral reference sensing points. The conductive leads are used to connect each of the peripheral reference sensing points and the central measuring sensing point to the connecting terminals. Furthermore, the measuring protrusion is aligned vertically with the central measuring sensing point, and the peripheral reference sensing points are evenly spaced and distributed above the reference plane.

4. The pelvic floor muscle strength direct detection system for simulated vaginal digital examination according to claim 3, characterized in that, The connection terminal includes one common electrode, one measuring electrode, and multiple reference electrodes. The number of reference electrodes is the same as the number of peripheral reference sensing points. The electrodes are evenly distributed in the vertical direction. The measuring electrode is located in the middle position, and the common electrode is located below the measuring electrode. The upper half of the central measuring sensing point is provided with a semi-circular cut. The arc surface of the semi-circular cut is located at the end away from the connection terminal. The common electrode is connected to the central measurement sensing point and each of the peripheral reference sensing points respectively; each of the peripheral reference sensing points is connected to the corresponding reference electrode in a top-to-bottom order via independent conductive leads, ensuring that no wires cross the sensing electrode surface; the central measurement sensing point is connected to the measurement electrode via an independent conductive lead.

5. The pelvic floor muscle strength direct detection system for simulated vaginal digital examination according to claim 3, characterized in that, The surfaces of each peripheral reference sensing point and the central measuring sensing point are all soft rubber contacts; each soft rubber contact has an arc-shaped protrusion structure, and each soft rubber contact is bonded to each peripheral reference sensing point and the central measuring sensing point using medical neutral silicone, flexible medical PU adhesive or UV adhesive, or each soft rubber contact is integrally formed with each peripheral reference sensing point and the central measuring sensing point.

6. The pelvic floor muscle strength direct detection system based on simulated vaginal digital examination according to claim 1, characterized in that, The integration of the flexible pressure sensing component with the index finger position of the detection glove includes: potting encapsulation, thermoforming encapsulation, or sewing wrapping encapsulation, wherein: The encapsulation process includes: positioning the thin-film sensor within a groove in the detection glove, and then injecting liquid transparent silicone that cures at room temperature. The hot-press encapsulation includes: laminating PU hot melt adhesive films above and below the thin-film sensor, and then fusing them with the fabric of the testing glove through high-temperature hot pressing; The sewing and packaging process includes wrapping the thin-film sensor with a thin non-woven fabric and then sewing it to the corresponding position on the detection glove.

7. The pelvic floor muscle strength direct detection system for simulated vaginal digital examination according to claim 1, characterized in that, The data receiving module is connected to the testing glove via a magnetic connector or a straight connector. The top of the data receiving module is provided with a magnetic connector, which has a recessed groove structure and multiple spring contacts distributed on its surface. The magnetic connector is connected to the magnetic connector to realize the connection between the data receiving module and the testing glove. The data receiving module has a quick-connect port on one side, and the straight connector is inserted into the quick-connect port to connect the data receiving module with the testing glove.

8. The pelvic floor muscle strength direct detection system for simulated vaginal digital examination according to claim 1, characterized in that, The data receiving module also has a circuit board, a rechargeable battery, and a wireless charging coil arranged from top to bottom in the middle position inside. The circuit board is equipped with a signal amplification unit, a filtering unit, and an AD conversion unit, wherein: The signal amplification unit is used to amplify the collected pressure signal; The filtering unit is used to filter the amplified pressure signal; The AD conversion unit is used to perform AD conversion processing on the filtered pressure signal.

9. The pelvic floor muscle strength direct detection system based on simulated vaginal digital examination according to claim 1, characterized in that, The data receiving module is fixed to the wrist via an arched memory elastic wristband or a flexible wristband, wherein: The data receiving module further includes: magnetic snap-fit ​​slots symmetrically formed at both ends of the bottom of the data receiving module, with a first magnet embedded at both ends of the inner wall of each magnetic snap-fit ​​slot. The arched memory elastic wristband includes: a long strip of memory elastic sheet, the two ends of which are pre-pressed into an arc-shaped structure with a central arch; a wristband support platform is provided in the middle of the memory elastic sheet; positioning blocks are symmetrically arranged on the upper surface of the wristband support platform, each positioning block matching the shape of the corresponding magnetic buckle slot, and the line connecting two positioning blocks is perpendicular to the axis of the memory elastic sheet; a second magnet is embedded at both ends inside each positioning block, the position of each second magnet corresponding to the position of the corresponding first magnet, and the polarity of the second magnet is opposite to that of the first magnet; the memory elastic sheet and the wristband support platform are also covered with a fully enclosed flexible sheath; the magnetic buckle slot of the data receiving module and the positioning block of the arched memory elastic wristband are concave and convex to achieve precise positioning; the first magnet of the data receiving module and the second magnet of the arched memory elastic wristband are attracted by opposite poles, so that the data receiving module is quickly and firmly fixed on the wristband support platform; And / or, the data receiving module further includes strap slots formed on both sides of the data receiving module, and the strap slots on both sides are connected to each other. The flexible wristband is inserted into the strap slots, and the flexible wristband is provided with an adjustable buckle to adapt to different wrist sizes by adjusting the buckle.

10. The pelvic floor muscle strength direct detection system based on simulated vaginal digital examination according to claim 1, characterized in that, The display and analysis unit includes a pelvic floor muscle display system and a pelvic floor muscle database.

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