Non-invasive pelvic floor electrical stimulation and biofeedback device and its implementation method

Abstract

Non-invasive pelvic floor electrical stimulation and biofeedback device and its implementation method, comprising: a main unit, the main unit includes a main unit housing, a main control module, a muscle / nerve stimulation electrical pulse signal generation module, and an electromyogram signal acquisition and processing module, the main control module is respectively connected to the muscle / nerve stimulation electrical pulse signal generation module and the electromyogram signal acquisition and processing module; a non-invasive electrode patch assembly, the non-invasive electrode patch assembly includes electrode one, electrode two, and electrode three, which are respectively placed outside the body and are of a non-invasive design. The non-invasive pelvic floor electrical stimulation and biofeedback device and its implementation method of the present invention adopt a non-invasive three-electrode design, which can not only avoid the health problems that may be caused by cross-use, but also achieve a stimulation effect similar to that of invasive electrical stimulation, improving the user experience. The device has a high degree of intelligence, is convenient to adjust, and can also allow the user to detect and observe the treatment effect in real time.

Description

Technical Field

[0001] The present invention belongs to the technical field of rehabilitation treatment and evaluation, and particularly relates to a non-invasive pelvic floor electrical stimulation and biofeedback device and an implementation method thereof. Background Art

[0002] The pelvic floor muscles refer to the muscle groups that enclose the pelvic floor and are used to support the normal position of pelvic organs to maintain their normal physiological functions. Pelvic floor dysfunction diseases are common in the elderly, postpartum women, and men who have undergone prostate cancer surgery. In recent years, the number of patients with pelvic floor dysfunction diseases in China has gradually increased, causing a great economic and mental burden to families and society, and attracting the key attention of clinical medical workers. Pelvic floor dysfunction diseases include various types of diseases, such as pelvic organ prolapse, sexual dysfunction, stress urinary incontinence, chronic pelvic pain, etc. Patients with pelvic floor dysfunction diseases have loose pelvic floor muscles and vaginal relaxation, and multiple organs will shift and prolapse, resulting in problems such as poor sexual life quality and urine leakage when laughing or coughing, which have a great impact on the physical and mental health of patients.

[0003] The invasive pelvic floor muscle and nerve electrical stimulator is a commonly used pelvic floor muscle and nerve electrical stimulation device in clinical practice, mainly composed of a main unit and an electrode probe. The stimulation site of the invasive electrode is the inner wall of the vagina, and the electrode or probe needs to be inserted into the vagina or anus. This treatment method is complex to operate, inconvenient to operate at home by oneself, and may cause discomfort or infection risk, reducing the user's treatment experience. At the same time, the current assessment of pelvic floor muscle and nerve rehabilitation mainly adopts an invasive scheme, which has many inconveniences and discomforts during the assessment and training process. For example, Chinese Patent Publication No. CN218685741U discloses a pelvic floor muscle treatment probe, Chinese Patent Publication No. CN116763315B discloses a pelvic floor electrode, and Chinese Patent Publication No. CN116173404A discloses an external pelvic floor muscle electrical stimulator and an electrical stimulation method (the specification of this patent

[0036] records that: the body at least includes the following electrodes or electrode groups: a vaginal electrode group 12, including a pair of electrodes symmetrically arranged on the surface of the small protrusion 11. When the body is properly installed in contact with the vulva, the small protrusion 11 is inserted into the vagina so that the vaginal electrode group can be in contact with the inner wall of the vagina; a tendon center electrode group 13, including two pairs of electrodes arranged in a cross shape. When the small protrusion 11 is correctly inserted into the vagina, the tendon center electrode group 13 can be in contact with the perineal center tendon; a labial electrode group 14, including a pair of electrodes symmetrically arranged on the left and right. When the small protrusion 11 is correctly inserted into the vagina, the labial electrode group 14 can be in contact with both sides of the middle section of the small labia). The probes in the above patents all adopt invasive probes. During the treatment process, the cylindrical probe will extend into the vagina of female patients or the rectum of male patients. When such a hard object extends into the body, the patient will have obvious discomfort. In addition, this invasive probe has very high requirements for its manufacturing process. Any unevenness of the structural parts and the imperfection of the joint between the metal electrode and the housing will bring discomfort such as compression and stabbing to the patient, and in severe cases, it may scratch the inner wall of the vagina or rectum.

[0004] The non-invasive pelvic floor muscle and nerve electrical stimulator, compared with others, does not require an internal probe and is more convenient to use. Chinese Patent Publication No. CN112190266B discloses a non-invasive pelvic floor muscle training and treatment system, which is based on the principle of an abdominal belt type piezoelectric film sensing device. Through a signal conditioning circuit coupled with a charge amplifier, the voltage signal is denoised and amplified, and the voltage signal is converted into a visual signal and output by the signal output module. This patent does not mention the non-invasive electrical stimulation scheme of the present invention. At the same time, the in-vivo muscle force signal received by the non-invasive pressure sensor used in this patent is relatively weak. The myoelectric signal evaluation adopted by the present invention is more reliable and effective than the muscle force signal. Chinese Patent Publication No. CN216855515U discloses a medical electrical stimulation treatment device. By attaching the electrodes to a predetermined position without having to be placed inside the patient's body, it can avoid bringing uncomfortable experiences to the patient. This patent only gives a conceptual idea and does not give specific invention implementation schemes, such as the specific implementation of the host, the design of the electrodes, the isolation design in the all-in-one machine, the depth compensation of myoelectric signal acquisition, etc. Moreover, this patent only has the function of electrical stimulation and does not include the functions of myoelectric intensity measurement, function evaluation, and biofeedback training. And because the non-invasive electrodes are outside the body, this makes the non-invasive electrodes farther away from the pelvic floor muscle group than the invasive electrodes. Therefore, the pelvic floor myoelectric signal collected by the non-invasive electrodes is necessarily weaker than that of the invasive electrodes. Therefore, it is very necessary to solve the problem of the relatively weak pelvic floor myoelectric signal collected by the non-invasive electrodes.

[0005] In addition, the control interface of the traditional pelvic floor muscle and nerve electrical stimulation all-in-one machine is on the body. The buttons and the touch screen are located in the upper front of the body, which is exactly opposite to the genitals of men and women. Patients need to lower their heads to operate, which is not only extremely inconvenient, but also unhygienic, and the privacy of people cannot be well protected. Especially during the operation of the instrument, the involuntary movement of the patient's body and the slight tremor of the thighs may accidentally touch the buttons and the touch screen on the host, interfering with and affecting the normal operation of the machine. Especially for male users, because the male genitals are protrusions, it is very easy to affect and accidentally touch the control buttons and the touch screen on the host.

[0006] Therefore, the purpose of the present invention is to provide a non-invasive pelvic floor electrical stimulation and biofeedback device and its implementation method. Using non-invasive electrodes, completely outside the body, contacting the skin at the perineum and coccyx parts outside the body, it completely solves the deficiencies of invasive electrodes. The device has a higher integration degree, more intelligent and user-friendly operation. By using a smartphone APP software combined with Bluetooth technology, the control of the host is transplanted to the smartphone, completely solving the many inconveniences in the use of patients, forming a stronger and complementary current stimulation, which is beneficial for patients to be in a stable treatment process. It also has the functions of myoelectric intensity measurement, function evaluation, and biofeedback training, and at the same time solves the problem of the relatively weak pelvic floor myoelectric signal collected by the non-invasive electrodes. Summary of the Invention

[0007] Object of the Invention: In order to overcome the deficiencies of the prior art in the above-mentioned background art, the object of the present invention is to provide a non-invasive pelvic floor electrical stimulation and biofeedback device and its implementation method. By adopting a non-invasive three-electrode design, it can not only avoid the health problems that may be caused by cross-use, but also achieve a treatment effect similar to that of invasive electrical stimulation, improving the treatment experience of users. It can implement pelvic floor muscle and nerve electrical stimulation, pelvic floor muscle function evaluation, biofeedback, with a high degree of intelligence, convenient adjustment, and can also allow users to detect and observe the treatment effect in real time, having a wide range of application prospects.

[0008] The object of the present invention is achieved through the following technical solutions:

[0009] A non-invasive pelvic floor electrical stimulation and biofeedback device, comprising:

[0010] A main unit, the main unit includes a main unit housing, a main control module, a muscle / nerve stimulation electrical pulse signal generation module, an electromyogram signal acquisition and processing module, and an isolation circuit. The main control module, the muscle / nerve stimulation electrical pulse signal generation module, the electromyogram signal acquisition and processing module, and the isolation circuit are arranged inside the main unit housing. The main control module is respectively connected to the muscle / nerve stimulation electrical pulse signal generation module and the electromyogram signal acquisition and processing module; an isolation circuit is arranged between the muscle / nerve stimulation electrical pulse signal generation module and the electromyogram signal acquisition and processing module; during the acquisition of surface electromyogram signals, a path compensation mechanism is set through the electromyogram signal acquisition and processing module to compensate for the attenuation of electromyogram signals transmitted from the pelvic floor muscles to the surface of the body. The electromyogram signal acquisition and processing module includes an electromyogram signal amplification module, an electromyogram signal compensation module, and an ADC (analog-to-digital converter);

[0011] A non-invasive electrode patch assembly, the non-invasive electrode patch assembly includes electrode one, electrode two, and electrode three. Electrode one and electrode two are arranged on the upper left and right sides of the upper surface of the main unit housing and are respectively connected to the muscle / nerve stimulation electrical pulse signal generation module and the electromyogram signal acquisition and processing module. Electrode three is arranged on one side outside the main unit housing and is respectively connected to the muscle / nerve stimulation electrical pulse signal generation module and the electromyogram signal acquisition and processing module through wires; when in use, a person sits on the main unit, electrode one and electrode two correspond to the perineum of the human body, and electrode three corresponds to the coccyx part of the human body; the non-invasive electrode patch assembly, the electromyogram signal amplification module, the electromyogram signal compensation module, the ADC, and the main control module are connected in sequence;

[0012] A control system, the control system is connected to the main control module.

[0013] The non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention is reasonably designed. It adopts a non-invasive three-electrode design, with 2 electrodes corresponding to the perineum of the human body and 1 electrode corresponding to the coccyx of the human body. While ensuring the stimulation effect, it greatly improves the user experience and acceptance level. In particular, the introduction of electrode three can introduce electromyographic stimulation pulse signals into the deep pelvic floor muscles, achieving a better stimulation effect. The non-invasive design can avoid the hygienic and health problems that may be caused by cross-use, achieve a treatment effect similar to that of invasive electrical stimulation, and enable users to have a higher acceptance of this treatment method, improving the user treatment experience.

[0014] The main unit integrates the functions of a pelvic floor muscle and nerve electrical stimulator and a biofeedback device. When in use, the user sits on the main unit. The control system controls the main control module of the main unit, and then the main control module controls the muscle / nerve stimulation electrical pulse signal generation module, which can generate and output electrical pulses with different electrical stimulation parameters for rehabilitation treatment. The main control module controls the electromyographic signal acquisition and processing module, which can collect electromyographic signals and transmit them to the control system to display the energy strength of the electromyographic signals, further guiding the user to perform biofeedback training such as contraction of the pelvic floor muscles. It is convenient to use. During the acquisition of surface electromyographic signals, a path compensation mechanism is set through the electromyographic signal acquisition and processing module to compensate for the attenuation of electromyographic signals transmitted from the pelvic floor muscles to the body surface, solving the problem of weak electromyographic signals of the pelvic floor muscles collected by non-invasive electrodes.

[0015] Furthermore, the above non-invasive pelvic floor electrical stimulation and biofeedback device is a non-invasive electrode design. The non-invasive electrodes are completely placed outside the user's body. Two of the electrodes are placed on the perineum of the human body, and the third electrode is placed on the coccyx. The present invention is different from the invasive scheme in the prior art. For female users, the invasive scheme requires placing the electrodes in the vagina, and for male users, it requires placing the electrodes in the rectum. The invasive scheme not only has a very poor user experience but also has risks such as disinfection and cross-infection. The outer shell of the main unit has an inclination angle of 0 - 20°. The outer shell of the main unit includes:

[0016] An upper shell;

[0017] A medical silicone pad. The upper surface of the upper shell fits with the user's buttocks, and a medical silicone pad is provided at the place where the upper surface of the upper shell contacts the ischium of the human buttocks. The thickness of the medical silicone pad is 1 - 10 mm. Electrode one and electrode two are arranged at the place where the upper surface of the upper shell contacts the perineum of the human body correspondingly. Electrode one and electrode two are symmetric left and right and are located inside the medical silicone pad and protrude from the medical silicone pad;

[0018] A lower shell, which is arranged below the upper shell and is connected to the upper shell;

[0019] The bottom of the lower shell is provided with an anti-slip silica gel pad.

[0020] The outer shell of the main body has a certain inclination angle, so that the first electrode and the second electrode on the outer shell of the main body also have appropriate inclination angles, and the first electrode and the second electrode protrude, so that they can better fit the skin of the perineum area of the human body. The upper surface of the upper shell fits the human buttocks, and a medical silica gel pad is provided at the place where it contacts the ischium of the human buttocks. The medical silica gel pad has a thickness of 1-10 mm, which improves the comfort of use. An anti-slip silica gel pad is provided at the bottom of the lower shell to prevent the main body from sliding during use and affecting the use effect.

[0021] Furthermore, the above non-invasive pelvic floor electrical stimulation and biofeedback device adopts a three-electrode design. In particular, the introduction of the third electrode at the coccyx part can guide the stimulation current to the deep pelvic floor muscle tissue. While enhancing the electrical stimulation effect, it can also effectively collect the feedback signals of the deep pelvic floor muscles. In the prior art, the energy of the stimulation pulse in the two-electrode design can only be concentrated near the electrode and within a very small range, and the electrical signals of the deep pelvic floor muscles cannot be collected. The structures of the first electrode and the second electrode are the same, and both include:

[0022] A metal electrode, and the metal electrode is made of 316L stainless steel;

[0023] A PI heating sheet, and the PI heating sheet is attached and arranged inside the metal electrode;

[0024] The third electrode is a silica gel electrode sheet, including:

[0025] A silica gel sheet;

[0026] A conductive hydrogel sheet, and the silica gel sheet and the conductive hydrogel sheet are combined into the third electrode.

[0027] The first electrode and the second electrode are metal electrodes made of 316L stainless steel material. 316L stainless steel is a highly corrosion-resistant material and can be used for a long time in a humid environment without being easily corroded. This enables the metal electrodes to maintain high stability and durability when contacting human tissues and liquids. It also has good electrical conductivity and can effectively transmit electrical stimulation. The PI heating sheet is a new type of heating element (also called Kapton heating film) and is widely used in high-precision temperature control and heating systems. Its material is polyimide (PI), which can withstand harsh environments such as high temperature, high pressure, strong acid and strong alkali, and has good stability and corrosion resistance. Using it inside the metal electrode can realize the heating of the metal electrode. It can not only make the first electrode and the second electrode have a constant temperature of 36-42 degrees Celsius (i.e., body temperature) for more comfortable use, but also be heated to between 42-45 degrees Celsius to achieve the effect of heat therapy, soothe the pelvic floor muscle nerves and fascia tissues, and help improve the efficiency of pelvic floor repair.

[0028] The third electrode uses a silicone electrode sheet, which is composed of a soft silicone sheet and a conductive hydrogel sheet, and has good flexibility and elasticity. This enables the third electrode to better fit the skin of the coccyx part of the human body, providing a comfortable treatment experience. The silicone electrode sheet will not cause irritation or discomfort to human tissues, provides good electrical conductivity, is not easily damaged during long-term use, and has a low cost of consumables in the later stage, with high cost performance.

[0029] The present invention uses 3 electrodes. The first and second electrodes are two perineum electrodes, and the third electrode is an electrode for the coccyx part. All are connected to the muscle / nerve stimulation electrical pulse signal generation module. During use, the positive and negative electrode positions can be continuously switched and are constantly changing during use, so it is not easy to cause fatigue and helps improve the repair efficiency of muscles and nerves.

[0030] Furthermore, for the above non-invasive pelvic floor electrical stimulation and biofeedback device, the control system is a mobile phone. There is an APP software on the mobile phone that cooperates with the host. The main control module is connected to the mobile phone via Bluetooth to achieve information interaction between the host and the mobile phone. Compared with the design in the prior art where the operation interface is set on the host and controlled through a touch screen, the present invention can completely avoid interference during the use process caused by involuntary movements of the user through the smartphone APP.

[0031] For convenient use, a mobile phone is selected for control. There is an APP software in the mobile phone that cooperates with the host. Through the APP software of the mobile phone, various parameters of the host can be adjusted to perform operations such as pelvic floor muscle and nerve electrical stimulation, pelvic floor muscle function evaluation, and biofeedback, and the operation conditions are transmitted to the mobile phone to help the user better understand the treatment effect, greatly improving the convenience of use and the user experience, and facilitating operation and feeling the treatment effect.

[0032] Furthermore, for the above non-invasive pelvic floor electrical stimulation and biofeedback device, it integrates electrical stimulation and electromyographic biofeedback, and through an isolation circuit design, effectively avoids mutual interference between the two modules. The host further includes:

[0033] A power management module, which is used for the power supply of the host;

[0034] A heating module. The isolation circuit and the heating module are connected in sequence, and the heating module is connected to the non-invasive electrode sheet assembly.

[0035] The main control module receives the parameter control input from the APP software of the mobile phone, controls the operation of the muscle / nerve stimulation electrical pulse signal generation module and generates stimulation pulses. At the same time, the main control module can also collect the electromyogram signals collected by the electromyogram signal acquisition and processing module and transmit them to the APP software of the mobile phone via Bluetooth. The power management module supplies power to other modules of the host. The muscle / nerve stimulation electrical pulse signal generation module generates electrical stimulation to the human body for treatment. The electromyogram signal acquisition and processing module receives the electromyogram signals of the human body and processes them, including amplifying the electromyogram signals and removing the electromyogram signals generated by non-pelvic floor muscles, to complete the biofeedback process. Since the electrical stimulation signal is strong while the electromyogram signal is weak, an isolation circuit is required between the two modules. Finally, the entire host is connected to the user end of the mobile phone via Bluetooth. The heating module can heat the non-invasive electrode patch assembly to near body temperature (36 - 42 degrees Celsius) according to the user's body sensation or treatment needs to reduce discomfort, and can also heat it to 42 - 45 degrees Celsius to achieve the effect of assisted thermotherapy.

[0036] Specifically: First, a mobile phone installed with the APP software supporting the host turns on the Bluetooth working mode, searches for and successfully connects to the paired Bluetooth device, and enables the APP software. This APP software mainly has functions such as electrical stimulation (muscle / nerve stimulation electrical pulse signal generation module), temperature control (heating module), myoelectric intensity measurement (myoelectric signal acquisition and processing module), function evaluation, biofeedback training, etc. (1) Electrical stimulation and temperature control: The configuration of electrical stimulation parameters is mainly achieved by selecting the stimulation mode. A set of stimulation parameters has been solidified for different stimulation modes. The specific stimulation parameters include the width of the stimulation pulse, the repetition period of the stimulation pulse, the duration of the stimulation pulse, the idle interval time, the total treatment duration, etc. The intensity of the stimulation pulse, that is, the voltage amplitude, can be flexibly adjusted by the user according to their own tolerance level in different stimulation modes. Regarding the temperature control of electrode one and electrode two, the user can also make independent selections according to the ambient temperature and their own physical sensations; (2) Myoelectric intensity measurement and function evaluation: The activation of the myoelectric signal acquisition and processing module is independent to avoid interference between the muscle / nerve stimulation electrical pulse signal generation module and the myoelectric signal acquisition and processing module. Under the voice prompt of the APP software, the user contracts their perineum or performs exercises such as lifting the anus to drive the activity of the pelvic floor muscles. The host collects the surface myoelectricity conducted to the body surface, completes the compensation for transmission attenuation loss, and finally transmits it to the mobile phone via wireless Bluetooth. The mobile phone makes a grade evaluation of the myoelectric function based on the strength of the myoelectric signal and feedbacks it to the user to further understand the treatment effect; (3) Biofeedback training: The APP software can also achieve biofeedback training. The mobile phone APP software reminds the user to contract the pelvic floor muscles through voice, and presents the contraction trajectory of the pelvic floor muscles to the user in a visual form, reminding the user to strengthen the contraction force, maintain the contraction time, relax the pelvic floor muscles and other functional exercises, and finally achieve the training result of biofeedback. In short, the introduction of the mobile phone APP software helps users better understand the treatment effect, greatly improves the convenience of use and the user experience, and facilitates the control and perception of the treatment effect.

[0037] Furthermore, for the above non-invasive pelvic floor electrical stimulation and biofeedback device, a myoelectric signal acquisition path compensation mechanism is designed. According to the position of the external electrodes and the depth of the contracted pelvic floor muscles, the attenuation of the pelvic floor myoelectric signal transmitted to the body surface is compensated, and more accurate pelvic floor myoelectric signals can be obtained for biofeedback. The muscle / nerve stimulation electrical pulse signal generation module includes a charge amplification module and an electrical signal output module, and the main control module, charge amplification module, electrical signal output module, and non-invasive electrode sheet assembly are connected in sequence; the myoelectric signal amplification module includes a low-pass filter module, a high-pass filter module, and a post-amplification module, and the non-invasive electrode sheet assembly, low-pass filter module, high-pass filter module, post-amplification module, myoelectric signal compensation module, ADC, and main control module are connected in sequence.

[0038] During pelvic floor muscle and nerve electrical stimulation, according to the electrical stimulation parameters sent by the mobile phone APP software, the main control module generates constant-current stimulation pulses through the charge amplification module and the electrical signal output module, and applies electrical stimulation to the perineum of the human body through electrode one and electrode two, and applies electrical stimulation to the coccyx part of the human body through electrode three.

[0039] When collecting the myoelectric signals of the human body, the myoelectric signals of the perineum and coccyx parts of the human body are collected through electrode one, electrode two, and electrode three. The myoelectric signals are amplified through the myoelectric signal amplification module, that is, first low-pass filtering is performed by the low-pass filtering module to filter out frequencies higher than the set specific frequency to reduce the influence caused by clutter signals, which can not only well preserve the myoelectric signals but also reduce the interference of the power frequency during the collection process. Then, high-pass filtering is performed by the high-pass filtering module. After passing through the low-pass filtering circuit, waveforms higher than the cut-off frequency can be filtered out, and then using high-pass filtering to filter out signals lower than the cut-off frequency to ensure that the myoelectric signals are not distorted. After filtering out the interference signals, further amplification processing is performed through the post-amplification circuit. The myoelectric signal compensation module establishes a compensation mechanism to compensate for the myoelectric signals lost during transmission, calculates their effective values, and finally transmits them to the mobile phone, allowing the user to detect and observe the treatment effect in real time.

[0040] The present invention also relates to an implementation method of the non-invasive pelvic floor electrical stimulation and biofeedback device, including an implementation method of pelvic floor muscle and nerve electrical stimulation, an implementation method of pelvic floor muscle function evaluation, and an implementation method of biofeedback.

[0041] Furthermore, for the implementation method of the non-invasive pelvic floor electrical stimulation and biofeedback device described above, the implementation method of pelvic floor muscle and nerve electrical stimulation includes the following steps:

[0042] S12: Set various parameters of pelvic floor muscle and nerve electrical stimulation through the APP software of the mobile phone. The parameters include but are not limited to treatment duration, pulse width, pulse amplitude, and electrode temperature;

[0043] S13: The user sits upright on the main unit, ensuring that electrode one and electrode two correspond to the perineum of the human body, and electrode one and electrode two are in close contact with the perineum of the human body; ensuring that electrode three corresponds to the coccyx part of the human body, and electrode three is in close contact with the coccyx part of the human body;

[0044] S14: The main unit is powered on, and the pelvic floor muscle and nerve electrical stimulation is started through the APP software of the mobile phone. The electrical stimulation signal is effectively transmitted to the pelvic floor muscle group through direct contact with the human skin by the silicone electrode sheet;

[0045] S15: The user adjusts the electrical stimulation intensity of the main unit and the temperature of each electrode sheet of the non-invasive electrode sheet assembly through the APP software of the mobile phone according to their own experience;

[0046] S16: Wait until the end of one cycle of treatment duration, and stop the pelvic floor muscle and nerve electrical stimulation.

[0047] Further, for the implementation method of the above non-invasive pelvic floor electrical stimulation and biofeedback device, the implementation method of the pelvic floor muscle function assessment includes the following steps:

[0048] S21: Select a flat and hard place and place the main unit horizontally.

[0049] S22: The user sits upright on the main unit, ensuring that electrode one and electrode two correspond to the perineum of the human body, and electrode one and electrode two are closely attached to the perineum of the human body; ensure that electrode three corresponds to the coccyx part of the human body, and electrode three is closely attached to the coccyx part of the human body.

[0050] S23: Power on the main unit to start the pelvic floor muscle function assessment or conduct the pelvic floor muscle function assessment after performing pelvic floor muscle and nerve electrical stimulation.

[0051] S24: The APP software on the mobile phone guides the user to contract the pelvic floor muscles through voice, including but not limited to lifting the anus or contracting the perineum, and simultaneously collects the myoelectric signals.

[0052] S25: Amplify the collected myoelectric signals through the myoelectric signal amplification module, compensate for the myoelectric signals lost during transmission through the myoelectric signal compensation module, convert them into digital signals that can be processed by the main control module through ADC, and the main control module calculates its effective value and transmits it to the mobile phone for display to conduct a function assessment of the pelvic floor muscle strength for the user's reference.

[0053] Collect the myoelectric signals caused by the subject's perineum contraction or anal lifting movement, conduct a muscle strength assessment, and divide the energy strength levels.

[0054] Further, for the implementation method of the above non-invasive pelvic floor electrical stimulation and biofeedback device, the implementation method of the biofeedback includes the following steps:

[0055] S31: Select a flat and hard place and place the main unit horizontally.

[0056] S32: The user sits upright on the main unit, ensuring that electrode one and electrode two correspond to the perineum of the human body, and electrode one and electrode two are closely attached to the perineum of the human body; ensure that electrode three corresponds to the coccyx part of the human body, and electrode three is closely attached to the coccyx part of the human body.

[0057] S33: Power on the main unit to start the biofeedback or conduct the biofeedback after performing pelvic floor muscle and nerve electrical stimulation.

[0058] S34: The APP software of the mobile phone guides the user to contract the pelvic floor muscles through voice, including but not limited to lifting the anus or contracting the perineum, and collects the myoelectric signals. At the same time, it guides the user to reach the expected contraction strength through the visual angle and maintain it for a period of time;

[0059] S35: The APP software of the mobile phone guides the user to relax the pelvic floor muscles through voice and rest for 1 - 10 minutes;

[0060] S36: According to the training plan of the biofeedback mode set by the APP software of the mobile phone, repeat the above process to complete the effect of training the pelvic floor muscles through biofeedback.

[0061] Use a non - invasive electrode patch component to feedback the contraction of the muscle, provide an exercise plan according to the evaluation result of the user, guide the subject to perform biofeedback rehabilitation training of the pelvic floor muscles, and enhance the function of the pelvic floor muscles.

[0062] During any implementation of the myoelectric stimulation treatment of the pelvic floor muscles, pelvic floor muscle function evaluation, and biofeedback, the muscle / nerve stimulation electrical pulse signal generation module combines 4 different frequencies of low - frequency pulses (five frequencies of 20Hz, 30Hz, 50Hz, 80Hz, 300Hz). Compared with a single - frequency pulse, it is easier to repair nerve - muscle tissue and can also prevent the increase in muscle tolerance caused by 20 - minute long - term electrical stimulation.

[0063] Compared with the prior art, the present invention has the following beneficial effects:

[0064] (1) The non-invasive pelvic floor electrical stimulation and biofeedback device disclosed by the present invention is reasonably designed, achieving the technical purpose of improving the user's treatment experience while not affecting the stimulation effect and being able to collect effective myoelectric signals, and having the beneficial effects of being convenient to use, improving comfort, ensuring the treatment effect, and avoiding the risk of infection; 1. Convenient to use and improve comfort: Compared with traditional pelvic floor muscle and nerve electrical stimulation instruments and methods, the non-invasive three-electrode design is adopted, with 2 electrodes corresponding to the perineum of the human body and 1 electrode corresponding to the coccyx of the human body. There is no need to insert electrodes or probes, resulting in little harm. While ensuring the stimulation effect, it greatly improves the user's experience and acceptance. The user can perform treatment at home by themselves without the operation of professional personnel; 2. Ensure the treatment effect: Through the introduction of the electrode three at the coccyx part and the direct contact of the silicone electrode patch with the human skin, the electrical stimulation signal is transmitted more directly and effectively to the pelvic floor muscle group, thus ensuring and enhancing the treatment effect, and also enabling the myoelectric signal to be transmitted more directly, reducing the loss and attenuation of the myoelectric signal, and giving real-time feedback on the treatment effect to the user; 3. Avoid the risk of infection: When each user uses it, an independent non-invasive electrode patch component can be equipped, avoiding the cross-infection and hygiene problems that may be brought about by the cross-use of electrodes among multiple people, and ensuring the safety and hygiene of the treatment; 4. Solve the problem that the pelvic floor myoelectric signal collected by the non-invasive electrode is weak.

[0065] (2) The implementation method of the non-invasive pelvic floor electrical stimulation and biofeedback device disclosed by the present invention is simple to operate and adjustable, and has high flexibility. Through the APP software of the mobile phone, various parameters of the host under different modes can be debugged to perform operations such as pelvic floor muscle and nerve electrical stimulation, pelvic floor muscle function assessment, biofeedback, etc., and the operation situation is transmitted to the mobile phone display screen to help the user better understand the treatment effect, greatly improving the convenience of use and the user's experience, and facilitating the control and perception of the treatment effect. Brief Description of the Drawings

[0066] Figure 1 It is a structural sketch of the non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention;

[0067] Figure 2 It is a structural schematic diagram of the non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention;

[0068] Figure 3 It is a structural schematic diagram of the main body housing of the non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention;

[0069] Figure 4 It is a schematic diagram of the bottom of the main body housing of the non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention;

[0070] Figure 5 Schematic diagram of the metal electrode structure of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0071] Figure 6 Schematic diagram of the PI heating sheet structure of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0072] Figure 7 Schematic diagram of the electrode three structure of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0073] Figure 8 Frame diagram of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0074] Figure 9 Schematic diagram of the muscle / nerve stimulation electrical pulse signal generation module of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0075] Figure 10 Schematic diagram of the electromyogram signal acquisition and processing module of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0076] Figure 11 Schematic diagram of transmitting the pelvic floor electromyogram signal of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention to each electrode patch on the human body surface;

[0077] Figure 12 Schematic diagram of the electrode three of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention located at the coccyx part of the body surface;

[0078] Figure 13 Comparison diagram of the traditional invasive two-electrode design (a) and the invasive three-electrode design (b) of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0079] Figure 14 Cross-sectional view of the stimulation electric field distribution of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0080] Figure 15 Three-dimensional view of the stimulation electric field distribution of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0081] Figure 16 Schematic diagram of the attenuation of the pelvic floor electromyogram signal of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention as the transmission distance increases;

[0082] Figure 17 Schematic diagram of compensating for the pelvic floor electromyogram signal lost during transmission of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

[0083] Figure 18 Schematic diagram of the effect of the pelvic floor muscle electrical signal compensation mechanism of the non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention;

[0084] Figure 19 Actual test diagram of the effect of the pelvic floor muscle electrical signal compensation mechanism of the non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention;

[0085] In the figure: main unit 1, main unit housing 11, upper shell 111, medical silica gel pad 112, lower shell 113, anti-slip silica gel pad 114, non-invasive electrode sheet assembly 2, electrode one 21, metal electrode 211, PI heating sheet 212, electrode two 22, electrode three 23, silica gel sheet 231, conductive hydrogel sheet 232, wire 233, control system 3, invasive electrode one c, invasive electrode two d. Specific embodiments

[0086] Next, Examples 1, 2, 3, and 4 will be combined with specific experimental data and appendices Figure 1-19 , and the technical solutions in the embodiments of the present invention will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the protection scope of the present invention.

[0087] Example 1 provides a non-invasive pelvic floor electrical stimulation and biofeedback device.

[0088] Example 1

[0089] As Figure 1-19 shown, Example 1 is a non-invasive pelvic floor electrical stimulation and biofeedback device, including a main unit 1, a non-invasive electrode sheet assembly 2, and a control system 3.

[0090] As Figure 1 , 2 , and 8 shown, the main unit 1 integrates the functions of a pelvic floor muscle and nerve electrical stimulator and a biofeedback device. The main unit 1 includes a main unit housing 11, a main control module, a muscle / nerve stimulation electrical pulse signal generation module, and a myoelectric signal acquisition and processing module. The non-invasive electrode sheet assembly 2 includes an electrode one 21, an electrode two 22, and an electrode three 23. The electrode one 21 and the electrode two 22 are arranged on the upper left and right sides of the upper surface of the main unit housing 11 and are respectively connected to the muscle / nerve stimulation electrical pulse signal generation module and the myoelectric signal acquisition and processing module. The electrode three 23 is arranged on one side outside the main unit housing 11 and is respectively connected to the muscle / nerve stimulation electrical pulse signal generation module and the myoelectric signal acquisition and processing module through a wire 233.

[0091] During use, a person sits on the main unit 1. The first electrode 21 and the second electrode 22 correspond to the perineum of the human body, and the third electrode 23 corresponds to the coccyx part of the human body. The control system 3 is a mobile phone, and an APP software that cooperates with the main unit 1 is set on the mobile phone, and information interaction between the main unit 1 and the mobile phone is realized through Bluetooth.

[0092] Further, as Figure 3 , 4 shown, the main unit housing 11 includes an upper shell 111, a medical silicone pad 112, a lower shell 113, and an anti-slip silicone pad 114. The upper surface of the upper shell 111 fits the human buttocks, and a medical silicone pad 112 is provided at the place where the upper surface of the upper shell 111 contacts the ischium of the human buttocks. The thickness of the medical silicone pad 112 is 5 mm, which improves the comfort of use. The first electrode 21 and the second electrode 22 are arranged at the place where the upper surface of the upper shell 111 contacts the perineum of the human body correspondingly. Due to the certain inclination angle of the main unit housing 11, the first electrode 21 and the second electrode 22 on the main unit housing 11 also have an appropriate inclination angle, and the first electrode 21 and the second electrode 22 protrude, so that they can better fit the skin of the perineum area of the human body. An anti-slip silicone pad 114 is provided at the bottom of the lower shell 113 to prevent the main unit 1 from sliding during use and affecting the use effect.

[0093] Further, as Figure 5 shown, the first electrode 21 and the second electrode 22 are made of metal electrodes 211 made of 316L stainless steel material. 316L stainless steel is a highly corrosion-resistant material and can be used for a long time in a humid environment without being easily corroded. This enables the metal electrode 211 to maintain high stability and durability when contacting human tissues and liquids, and also has good electrical conductivity, enabling effective transmission of electrical stimulation. As Figure 6 shown, the PI heating sheet 212 is a material with good insulation and high-temperature resistance. Using it inside the metal electrode 211 can realize heating of the metal electrode. It can make the first electrode 21 and the second electrode 22 have a constant temperature of 36 - 42 degrees Celsius (i.e., body temperature), making it more comfortable to use, and can also be heated to between 42 - 45 degrees Celsius to achieve the effect of heat therapy, soothe the pelvic floor muscle nerves and fascia tissues, and help improve the efficiency of pelvic floor repair.

[0094] As Figure 7 shown, the third electrode 23 is composed of a soft silicone sheet 231 and a conductive hydrogel sheet 232, and has good softness and elasticity. This enables the third electrode 23 to better fit the skin of the coccyx part of the human body and provide a comfortable treatment experience. The silicone electrode sheet will not cause irritation or discomfort to human tissues, provides good electrical conductivity, is not easily damaged during long-term use, and has a low cost of later consumables and high cost performance.

[0095] The present invention uses three electrodes. Electrode 1 (21) and Electrode 2 (22) are two perineum electrodes, and Electrode 3 (23) is an electrode at the coccyx position. All of them are connected to the muscle / nerve stimulation electrical pulse signal generation module. During use, the positive and negative electrode positions can be continuously switched, and they are constantly changing during use. In this way, it is not easy to cause fatigue and helps improve the repair efficiency of muscles and nerves.

[0096] Furthermore, as Figure 8 shown, the host 1 includes a main control module, a muscle / nerve stimulation electrical pulse signal generation module, a power management module, an isolation circuit, a heating module, and an electromyogram signal acquisition and processing module. The main control module realizes information interaction with the mobile phone through Bluetooth. The main control module is connected to the muscle / nerve stimulation electrical pulse signal generation module, and the main control module is connected to the electromyogram signal acquisition and processing module. There is a power management module, and the power management module supplies power to other modules of the host 1. An isolation circuit is provided between the muscle / nerve stimulation electrical pulse signal generation module and the electromyogram signal acquisition and processing module. The isolation circuit and the heating module are connected in sequence, and the heating module is respectively connected to the electrodes in sequence.

[0097] Furthermore, as Figure 9 shown, the muscle / nerve stimulation electrical pulse signal generation module includes a charge amplification module and an electrical signal output module. The main control module (CPU), the charge amplification module, the electrical signal output module, and the non-invasive electrode sheet assembly 2 are connected in sequence. During pelvic floor muscle and nerve electrical stimulation, the main control module (CPU) generates a constant-current stimulation pulse through the charge amplification module and the electrical signal output module according to the electrical stimulation parameters sent by the mobile phone APP software, and applies electrical stimulation to the human perineum through Electrode 1 (21) and Electrode 2 (22), and applies electrical stimulation to the human coccyx position through Electrode 3 (23).

[0098] Electrode 3 (23) is located on the body surface at the coccyx position of the human body as Figure 12 shown. The introduction of the design of Electrode 3 (23) can well guide and transmit the electrical stimulation signal to the deep pelvic floor tissue. At the same time, the electromyogram signal of the deep pelvic floor muscle can also be effectively collected through Electrode 3 (23). As Figure 13 shown in (b), the present invention designs a completely non-invasive electrode design. Among them, two electrodes (Electrode 1 (21) and Electrode 2 (22)) are located on both sides of the perineum, and another electrode (Electrode 3 (23)) is located on the body surface at the coccyx position. This design is completely different from the invasive electrode design located in the cavity (such as Figure 13 shown in (a), including invasive electrode 1 (c) and invasive electrode 2 (d)), greatly improving the convenience and experience of users. The present invention adopts a non-invasive three-electrode design. The introduction of the third electrode at the coccyx position can effectively guide the electrical stimulation to the deep pelvic floor muscle group, achieving a stimulation effect similar to that of invasive electrical stimulation. At the same time, it helps to collect the electromyogram signal of the pelvic floor muscle. The distribution of the stimulation electric field is asFigure 14 , 15 as shown.

[0099] Furthermore, as Figure 10 shown, the electromyogram (EMG) signal acquisition and processing module includes an EMG signal amplification module, an EMG signal compensation module, and an ADC. The non-invasive electrode patch assembly 2, the EMG signal amplification module, the EMG signal compensation module, the ADC, and the main control module (CPU) are connected in sequence. As Figure 11 shown, when collecting human EMG signals, the EMG signals of the perineum and coccyx regions of the human body are collected through electrode 1 21, electrode 2 22, and electrode 3 23.

[0100] Furthermore, the EMG signals are amplified by the EMG signal amplification module. First, a low-pass filter module is used for low-pass filtering to filter out frequencies higher than a set specific frequency to reduce the influence caused by clutter signals, which can not only well preserve the EMG signals but also reduce the interference of the power frequency during the acquisition process. Then, a high-pass filter module is used for high-pass filtering. After passing through the low-pass filter circuit, waveforms higher than the cut-off frequency can be filtered out, and then the signals lower than the cut-off frequency are filtered out using the high-pass filter to ensure that the EMG signals are not distorted. After filtering out the interference signals, further amplification processing is performed through a post-amplification circuit. The EMG signal compensation module establishes a compensation mechanism to compensate for the EMG signals lost during transmission, calculates their effective values, and finally transmits them to the mobile phone, allowing the user to detect and observe the treatment effect in real time.

[0101] Since the non-invasive electrode is outside the body, this makes the non-invasive electrode farther away from the pelvic floor muscle group compared to the invasive electrode. Therefore, the pelvic floor EMG signals collected by the non-invasive electrode are necessarily weaker than those of the invasive electrode.

[0102] As Figure 16-19 shown, by adding an EMG signal compensation module to the EMG signal acquisition and processing module, a path compensation mechanism is designed to compensate for the attenuation caused by the pelvic floor muscle propagation path. The EMG signals emitted by the pelvic floor muscles decay exponentially with the increase in the transmission distance:

[0103] ;

[0104] where α is the attenuation exponent and x is the transmission distance.

[0105] Therefore, an EMG signal compensation mechanism is established through the EMG signal compensation module:

[0106] .

[0107] So that the compensated EMG signal value is the actual size of the EMG signal generated by the pelvic floor muscles:

[0108] .

[0109] Before performing the operation of pelvic floor muscle function evaluation and biofeedback, the present invention first calculates the effective value of the compensated pelvic floor electromyogram signals collected. For the effective value of the electromyogram signals The calculation formula is as shown in the following formula:

[0110] ;

[0111] where v is the voltage of the collected electromyogram signal, t is the time, and T is the average time for effective value calculation.

[0112] Using the non-invasive pelvic floor electrical stimulation and biofeedback device of Embodiment 1 for treatment is a non-invasive treatment method that can improve the user experience. Compared with traditional treatment methods, the non-invasive pelvic floor electrical stimulation and biofeedback device of Embodiment 1 avoids the cross-infection and hygiene problems that may be brought about by the cross-use of electrodes among multiple people. At the same time, the electrode one 21 and the electrode two 22 are installed and fixed on the main body 1. This connection method is relatively simple and easy to implement, and has good durability and reliability, reducing the movement of the electrode sheet and maintaining the stability of the treatment process.

[0113] Embodiment 2 provides an implementation method of pelvic floor muscle and nerve electrical stimulation using the non-invasive pelvic floor electrical stimulation and biofeedback device of Embodiment 1.

[0114] Embodiment 2

[0115] As Figure 1-19 shown, the implementation method of pelvic floor muscle and nerve electrical stimulation of the non-invasive pelvic floor electrical stimulation and biofeedback device of Embodiment 2 specifically includes the following steps:

[0116] S11: Select a flat and hard place and place the main body 1 in a horizontal position;

[0117] S12: Set the parameters of pelvic floor muscle and nerve electrical stimulation through the APP software of the mobile phone. The parameters include but are not limited to treatment duration, pulse width, pulse amplitude, and electrode temperature;

[0118] S13: The user sits upright on the main body 1, ensuring that the electrode one 21 corresponds to the perineum of the human body, and the electrode one 21 and the electrode two 22 are in close contact with the perineum; ensuring that the electrode three 23 corresponds to the coccyx part of the human body, and the electrode three 23 is in close contact with the coccyx part;

[0119] S14: The main body 1 is powered on, and the pelvic floor muscle and nerve electrical stimulation is started through the APP software of the mobile phone. The non-invasive electrode sheet assembly 2 directly contacts the human skin, enabling the electrical stimulation signal to be effectively transmitted to the pelvic floor muscle group;

[0120] S15: The user adjusts the electrical stimulation intensity of the main unit 1 and the temperature of each electrode piece 212 of the non-invasive electrode piece assembly 2 according to their own experience through the APP software on the mobile phone;

[0121] S16: When the treatment duration of one cycle ends, the pelvic floor muscle and nerve electrical stimulation stops.

[0122] Embodiment 3 provides an implementation method for pelvic floor muscle function evaluation using the non-invasive pelvic floor electrical stimulation and biofeedback device of Embodiment 1.

[0123] Embodiment 3

[0124] As Figure 1-19 shown, the implementation method for pelvic floor muscle function evaluation of the non-invasive pelvic floor electrical stimulation and biofeedback device in Embodiment 3 specifically includes the following steps:

[0125] S21: Select a flat and hard place and place the main unit 1 in a horizontal position;

[0126] S22: The user sits upright on the main unit 1, ensuring that the first electrode 21 and the second electrode 22 correspond to the perineum of the human body, and the first electrode 21 and the second electrode 22 are in close contact with the perineum; ensure that the third electrode 23 corresponds to the coccyx part of the human body, and the third electrode 23 is in close contact with the coccyx part;

[0127] S23: Turn off the implementation of pelvic floor muscle function evaluation through the mobile phone and conduct the implementation of pelvic floor muscle function evaluation;

[0128] S24: The APP software on the mobile phone guides the user to contract the pelvic floor muscles through voice, including but not limited to lifting the anus or contracting the perineum, and simultaneously collects the myoelectric signals;

[0129] S25: Amplify the collected myoelectric signals through the myoelectric signal amplification module, compensate for the myoelectric signals lost during transmission through the myoelectric signal compensation module, convert them into digital signals that can be processed by the main control module through ADC, and the main control module calculates their effective values and transmits them to the mobile phone for display to conduct a functional evaluation of the pelvic floor muscle strength for the user's reference.

[0130] Embodiment 4 provides an implementation method for biofeedback using the non-invasive pelvic floor electrical stimulation and biofeedback device of Embodiment 1.

[0131] Embodiment 4

[0132] As Figure 1-19 shown, the implementation method for biofeedback of the non-invasive pelvic floor electrical stimulation and biofeedback device in Embodiment 4 specifically includes the following steps:

[0133] S31: Select a flat and hard place and place the main unit 1 in a horizontal position;

[0134] S32: The user is sitting on the main unit 1, ensuring that the first electrode 21 and the second electrode 22 correspond to the perineum of the human body, and the first electrode 21 and the second electrode 22 are in close contact with the perineum; ensuring that the third electrode 23 corresponds to the coccyx part of the human body, and the third electrode 23 is in close contact with the coccyx part;

[0135] S33: Turn off the implementation of the pelvic floor muscle function assessment through the mobile phone and conduct the implementation of biofeedback;

[0136] S34: The APP software of the mobile phone guides the user to contract the pelvic floor muscles through voice, including but not limited to lifting the anus or contracting the perineum, and collects the myoelectric signals. At the same time, it guides the user to reach the expected value of the contraction strength through the visual angle and maintains it for a period of time;

[0137] S35: The APP software of the mobile phone guides the user to relax the pelvic floor muscles through voice and rest for 1 - 10 minutes;

[0138] S36: According to the training plan of the biofeedback mode set by the APP software of the mobile phone, repeat the above process to complete the effect of training the pelvic floor muscles through biofeedback.

[0139] The specific application ways of the present invention are numerous, and the above - mentioned is only the preferred implementation manner of the present invention. It should be noted that the above embodiments are only used to illustrate the present invention and do not limit the protection scope of the present invention. For those of ordinary skill in the art in this technical field, without departing from the principle of the present invention, several improvements can be made, and these improvements should also be regarded as the protection scope of the present invention.

Claims

1. A non-invasive pelvic floor electrical stimulation and biofeedback device, characterized in that: include: A host (1), the host (1) comprising a host housing (11), a main control module, a muscle / nerve stimulation electric pulse signal generating module, an electromyographic signal acquisition and processing module, and an isolation circuit, wherein the main control module, the muscle / nerve stimulation electric pulse signal generating module, the electromyographic signal acquisition and processing module, and the isolation circuit are arranged inside the host housing (11), the main control module is connected to the muscle / nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module respectively; an isolation circuit is arranged between the muscle / nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module; During the electromyographic signal acquisition process, a path compensation mechanism is set through the electromyographic signal acquisition and processing module to compensate for the attenuation of the electromyographic signal transmitted from the pelvic floor muscle to the body surface. The electromyographic signal acquisition and processing module includes an electromyographic signal amplification module, an electromyographic signal compensation module, and an ADC; The electromyographic signal emitted by the pelvic floor muscles decays exponentially as the transmission distance increases: ； Where α is the attenuation exponent and x is the transmission distance; Therefore, the compensation mechanism of the electromyographic signal is established through the electromyographic signal compensation module: ; The compensated electromyographic signal value is the actual electromyographic signal size generated by the pelvic floor muscles: ; The collected compensated pelvic floor electromyography signal is calculated for its effective value. The calculation formula is as follows: ； Where v is the voltage of the collected electromyographic signal, t is the time, and T is the average time for effective value calculation; A non-invasive electrode sheet assembly (2), the non-invasive electrode sheet assembly (2) comprising an electrode 1 (21), an electrode 2 (22), and an electrode 3 (23); the electrode 1 (21) and the electrode 2 (22) are arranged on the left and right sides of the upper part of the upper surface of a host housing (11) and are respectively connected to a muscle / nerve stimulation electric pulse signal generating module and an electromyographic signal acquisition and processing module; the electrode 3 (23) is arranged on one side outside the host housing (11) and is respectively connected to the muscle / nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module through a wire (233); when in use, a human body sits on the host (1), the electrode 1 (21) and the electrode 2 (22) correspond to the perineum of the human body, and the electrode 3 (23) corresponds to the coccyx of the human body; the non-invasive electrode sheet assembly (2), the electromyographic signal amplification module, the electromyographic signal compensation module, the ADC, and the main control module are connected in sequence; A control system (3), wherein the control system (3) is connected to a main control module.

2. The non-invasive pelvic floor electrical stimulation and biofeedback device according to claim 1, characterized in that: The host housing (11) has an inclination angle of 0-20°, and the host housing (11) comprises: Upper shell (111); A medical silicone pad (112), wherein the upper surface of the upper shell (111) fits against the buttocks of a human body, and the medical silicone pad (112) is arranged at a location where the upper surface of the upper shell (111) contacts the ischium of the buttocks of a human body; the thickness of the medical silicone pad (112) is 1-10 mm; the electrode 1 (21) and the electrode 2 (22) are arranged at a location where the upper surface of the upper shell (111) contacts the perineum of a human body, and the electrode 1 (21) and the electrode 2 (22) are symmetrical and located on the inner side of the medical silicone pad (112) and protrude from the medical silicone pad (112); A lower shell (113), wherein the lower shell (113) is arranged below the upper shell (111) and connected to the upper shell (111); An anti-skid silicone pad (114), wherein an anti-skid silicone pad (114) is arranged at the bottom of the lower shell (113).

3. The non-invasive pelvic floor electrical stimulation and biofeedback device according to claim 1, characterized in that: The structures of the electrode 1 (21) and the electrode 2 (22) are the same, and both include: A metal electrode (211), wherein the metal electrode (211) is made of 316L stainless steel; A PI heating sheet (212), wherein the PI heating sheet (212) is disposed in close contact with the metal electrode (211); The electrode three (23) is a silicone electrode sheet, comprising: Silicone sheet (231); A conductive hydrogel sheet (232), wherein the silicone sheet (231) and the conductive hydrogel sheet (232) are combined to form an electrode three (23).

4. The non-invasive pelvic floor electrical stimulation and biofeedback device according to claim 1, characterized in that: The control system (3) is a mobile phone, on which is provided an APP software that matches the host (1), and the main control module is connected to the mobile phone via Bluetooth to achieve information interaction between the host (1) and the mobile phone.

5. The non-invasive pelvic floor electrical stimulation and biofeedback device according to claim 1, characterized in that: The host (1) further comprises: A power management module, the power management module is used to supply power to the host (1); A heating module, wherein the isolation circuit and the heating module are connected in sequence, and the heating module is connected to the non-invasive electrode sheet assembly (2).

6. The non-invasive pelvic floor electrical stimulation and biofeedback device according to claim 5, characterized in that: The muscle / nerve stimulation electric pulse signal generating module comprises a charge amplification module and an electric signal output module, and the main control module, the charge amplification module, the electric signal output module, and the non-invasive electrode sheet assembly (2) are connected in sequence; the electromyographic signal amplification module comprises a low-pass filter module, a high-pass filter module, and a post-amplification module, and the non-invasive electrode sheet assembly (2), the low-pass filter module, the high-pass filter module, the post-amplification module, the electromyographic signal compensation module, the ADC, and the main control module are connected in sequence.

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