CN118217531A - Non-invasive pelvic floor electrical stimulation and biofeedback device and implementation method thereof - Google Patents

Abstract

A non-invasive pelvic floor electrical stimulation and biofeedback device and method of practicing same, comprising: the main machine comprises a main machine shell, a main control module, a muscle/nerve stimulation electric pulse signal generating module and an electromyographic signal collecting and processing module, wherein the main control module is respectively connected with the muscle/nerve stimulation electric pulse signal generating module and the electromyographic signal collecting and processing module; the non-invasive electrode slice assembly comprises an electrode I, an electrode II and an electrode III which are respectively arranged outside the body and is of a non-invasive design. The non-invasive pelvic floor electric stimulation and biofeedback device and the implementation method thereof adopt the design of the non-invasive three electrodes, so that not only can the sanitary health problem possibly caused by cross use be avoided, but also the stimulation effect similar to the invasive electric stimulation can be achieved, the use experience of a user is improved, the device has high intelligent degree, the adjustment is convenient, and the user can also detect and observe the treatment effect in real time.

Description

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

Technical Field

The present invention belongs to the technical field of rehabilitation treatment and assessment, and in particular relates to a non-invasive pelvic floor electrical stimulation and biofeedback device and an implementation method thereof.

Background technique

The pelvic floor muscles refer to the muscle groups that close the pelvic floor and are used to support the normal position of the pelvic organs to maintain their normal physiological functions. Pelvic floor dysfunction is 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 in my country has gradually increased, causing great economic and mental burdens on families and society, and has attracted the attention of clinical medical workers. Pelvic floor dysfunction includes various types of diseases, such as pelvic organ prolapse, sexual dysfunction, stress urinary incontinence, chronic pelvic pain, etc. Patients with pelvic floor dysfunction have loose pelvic floor muscles and vaginal relaxation, and multiple organs will shift and prolapse, resulting in poor quality of sex life, urinary incontinence when laughing or coughing, and other problems, which have a great impact on the patient's physical and mental health.

The invasive pelvic floor muscle and nerve electrical stimulator is a commonly used pelvic floor muscle and nerve electrical stimulation device in clinical practice, which is mainly composed of a host 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 complicated to operate, inconvenient to operate at home, and may cause discomfort or infection risks, reducing the user's treatment experience. At the same time, the current evaluation of pelvic floor muscle and nerve rehabilitation also mainly adopts invasive solutions, which cause many inconveniences and discomforts during the evaluation 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 in vitro pelvic floor muscle electrical stimulator and electrical stimulation method (the specification [0036] of the patent states: the body includes at least the following electrodes or electrode groups: a vaginal electrode group 12, including a pair of electrodes symmetrically arranged on the surface of a small protrusion 11, when the body is installed in place against the vulva, the small protrusion 11 is inserted into the vagina so that the vaginal electrode group can fit the inner wall of the vagina; a tendon center electrode group 13, including two pairs of electrodes arranged in a cross, when the small protrusion 11 is correctly inserted into the vagina, the tendon center electrode group 13 can fit the perineum center tendon; a labia 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 labia electrode group 14 The probes in the above patents are all invasive probes. During the treatment, the cylindrical rod-shaped probe will be inserted into the vagina of female patients or the rectum of male patients. When this hard object is inserted into the body, the patient will feel obvious discomfort. In addition, this invasive probe has very high requirements for its manufacturing process. Any unevenness of the structural parts and imperfections in the joints between the metal electrodes and the shell will cause discomfort such as pressure and tingling to the patient. In severe cases, the inner wall of the vagina or rectum may be scratched.

In comparison, non-invasive pelvic floor muscle and nerve electrical stimulators do not require built-in probes and are more convenient to use. Chinese Patent Announcement No. CN112190266B discloses a non-invasive pelvic floor muscle training treatment system, which is based on the principle of an abdominal belt-type piezoelectric film sensor device. Through a signal conditioning circuit coupled to a charge amplifier, the voltage signal is denoised and amplified, and the voltage signal is converted into a visual signal and output by a signal output module. The 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 patent using a non-invasive pressure sensor will be weak. The electromyographic signal evaluation used in the present invention is more reliable and effective than the muscle force signal. Chinese Patent Announcement No. CN216855515U discloses a medical electrical stimulation treatment device, which can avoid giving patients an uncomfortable experience by placing the electrodes against a predetermined position without having to be placed in the patient's body. The patent only gives a conceptual idea, and does not give a specific invention implementation plan, such as the specific implementation of the host, the design of the electrodes, the isolation design in the all-in-one machine, and the depth compensation of the electromyographic signal acquisition. Moreover, this patent only has the function of electrical stimulation, and does not include the functions of EMG strength measurement, functional evaluation, and biofeedback training. Moreover, since the non-invasive electrodes are outside the body, they are farther away from the pelvic floor muscles than the invasive electrodes, so the pelvic floor EMG signals collected by the non-invasive electrodes are necessarily weaker than those collected by the invasive electrodes. Therefore, it is very necessary to solve the problem of weak pelvic floor EMG signals collected by the non-invasive electrodes.

In addition, the control interface of the traditional pelvic floor muscle and nerve electrical stimulation all-in-one machine is on the body, and the buttons and touch screen are on the front upper part of the body, which is right in front of the male and female genitals. Patients need to lower their heads to operate, which is not only extremely inconvenient, but also unhygienic, and people's privacy cannot be well protected. Especially when the instrument is working, the patient's involuntary movement of the body and the slight shaking of the thigh may accidentally touch the buttons and 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, which are very easy to affect and accidentally touch the control buttons and touch screen on the host.

Therefore, the purpose of the present invention is to provide a non-invasive pelvic floor electrical stimulation and biofeedback device and an implementation method thereof, which uses non-invasive electrodes, is completely outside the body, and contacts the skin of the perineum and coccyx outside the body, completely solving the shortcomings of invasive electrodes, and the device has a higher degree of integration, and the operation is more intelligent and humanized. It uses a smartphone APP software combined with Bluetooth technology to transplant the control of the host to the smartphone, which completely solves many inconveniences in patient use, forms a more intense and complementary current stimulation, and is conducive to the patient being in a stable treatment process. It also has the functions of electromyography intensity measurement, functional evaluation, and biofeedback training, and at the same time solves the problem of weak pelvic floor electromyography signals collected by non-invasive electrodes.

Summary of the invention

Purpose of the invention: In order to overcome the deficiencies of the prior art in the above-mentioned background technology, the purpose of the present invention is to provide a non-invasive pelvic floor electrical stimulation and biofeedback device and an implementation method thereof, which adopts 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 therapeutic effect similar to that of invasive electrical stimulation, thereby improving the user's treatment experience, and can implement pelvic floor muscle and nerve electrical stimulation, pelvic floor muscle function assessment, and biofeedback. It has a high degree of intelligence and is easy to adjust. It can also allow users to detect and observe the treatment effect in real time, and has broad application prospects.

The objective of the present invention is achieved through the following technical solutions:

Non-invasive pelvic floor electrical stimulation and biofeedback device, including:

A host, the host comprising a host housing, a main control module, a muscle/nerve stimulation electric pulse signal generating module, an electromyographic signal acquisition and processing module, and an isolation circuit. 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, and the main control module is respectively connected to the muscle/nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module; an isolation circuit is arranged between the muscle/nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module; in the process of collecting electromyographic signals on the body surface, a path compensation mechanism is arranged through the electromyographic signal acquisition and processing module to compensate for the attenuation of the electromyographic signals transmitted from the pelvic floor muscles to the body surface, and the electromyographic signal acquisition and processing module comprises an electromyographic signal amplification module, an electromyographic signal compensation module, and an ADC (analog-to-digital converter);

A non-invasive electrode sheet assembly, the non-invasive electrode sheet assembly includes electrode 1, electrode 2, and electrode 3. The electrode 1 and electrode 2 are arranged on the left and right sides of the upper surface of the mainframe housing and are respectively connected to the muscle/nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module. The electrode 3 is arranged on one side outside the mainframe housing and is respectively connected to the muscle/nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module through wires. When in use, a human body sits on the mainframe, the electrode 1 and the electrode 2 correspond to the perineum of the human body, and the electrode 3 corresponds to the coccyx of the human body. The non-invasive electrode sheet assembly, the electromyographic signal amplification module, the electromyographic signal compensation module, the ADC, and the main control module are connected in sequence.

A control system is connected to the main control module.

The non-invasive pelvic floor electrical stimulation and biofeedback device described in the present invention is reasonably designed and adopts a non-invasive three-electrode design, with two electrodes corresponding to the human perineum and one electrode corresponding to the human coccyx. While ensuring the stimulation effect, it greatly improves the user's experience and reception, especially the introduction of electrode three, which can introduce the myoelectric stimulation pulse signal into the deep pelvic floor muscle to achieve a better stimulation effect. The non-invasive design can avoid the health problems that may be caused by cross-use, achieve a treatment effect similar to that of invasive electrical stimulation, and allow users to have a higher degree of acceptance of the treatment method, thereby improving the user's treatment experience.

The host integrates the functions of pelvic floor muscle and nerve electrical stimulator and biofeedback device. When in use, the human body sits on the host, and the control system controls the main control module of the host, and then the main control module controls the muscle/nerve stimulation electric pulse signal generating module, which can generate and output electric 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, and further guide the user to perform pelvic floor muscle contraction biofeedback training, etc., which is easy to use. In the process of surface electromyographic signal acquisition, a path compensation mechanism is set by the electromyographic signal acquisition and processing module to compensate for the attenuation of the electromyographic signals transmitted from the pelvic floor muscles to the surface of the body, solving the problem of weak pelvic floor electromyographic signals acquired by non-invasive electrodes.

Furthermore, the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device is a non-invasive electrode design, in which the non-invasive electrodes are completely placed outside the user's body, two electrodes are placed on the perineum, and the third electrode is placed on the coccyx. The present invention is different from the invasive solution in the prior art. The invasive solution requires the electrodes to be placed in the vagina for female users and in the rectum for male users. The invasive solution not only has a poor user experience, but also has risks such as disinfection and cross infection. The host housing has a tilt angle of 0-20°, and the host housing includes:

Upper shell;

A medical silicone pad, wherein the upper surface of the upper shell fits the buttocks of a human body, and the medical silicone pad is arranged at the place where the upper surface of the upper shell contacts the ischium of the buttocks of a human body; the thickness of the medical silicone pad is 1-10 mm; the electrode 1 and the electrode 2 are arranged at the place where the upper surface of the upper shell contacts the corresponding perineum of a human body, and the electrode 1 and the electrode 2 are symmetrical and located on the inner side of the medical silicone pad and protrude from the medical silicone pad;

A lower shell, the lower shell is arranged below the upper shell and connected to the upper shell;

Anti-skid silicone pad: an anti-skid silicone pad is arranged at the bottom of the lower shell.

The host shell has a certain tilt angle, so that the electrode 1 and the electrode 2 on the host shell also have a suitable tilt angle, and the electrode 1 and the electrode 2 are protruding, so that they can better fit the skin of the perineum of the human body. The upper surface of the upper shell fits the human buttocks, and a medical silicone pad is provided at the place where it contacts the ischium of the human buttocks. The medical silicone pad has a thickness of 1-10mm, which improves the comfort of use. An anti-slip silicone pad is provided at the bottom of the lower shell to prevent the host from sliding during use and affecting the use effect.

Furthermore, the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device adopts a three-electrode design, especially the introduction of the third electrode at the coccyx, which 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 signal of the deep pelvic floor muscle. 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 it is impossible to collect the deep pelvic floor muscle electroelectric signal. The structure of the electrode one and the electrode two is the same, both including:

Metal electrode, the metal electrode is made of 316L stainless steel;

A PI heating sheet, wherein the PI heating sheet is laminated and arranged inside the metal electrode;

The electrode three is a silicone electrode sheet, comprising:

Silicone sheet;

Conductive hydrogel sheet, the silicone sheet and the conductive hydrogel sheet are combined to form electrode three.

The electrode 1 and the electrode 2 are metal electrodes made of 316L stainless steel. 316L stainless steel is a highly corrosion-resistant material that can be used for a long time in a humid environment without being easily corroded. This allows the metal electrode to maintain high stability and durability when in contact with human tissue and liquids, and also has good electrical conductivity and can effectively transmit electrical stimulation. The PI heating sheet is a new type of heating element (also known as Kapton heating film), which is widely used in high-precision temperature control and heating systems. Its material is polyimide (PI), which can withstand high temperature, high pressure, strong acid and alkali and other harsh environments, and has good stability and corrosion resistance. It can be used inside the metal electrode to heat the metal electrode, which can make the electrode 1 and the electrode 2 have a constant temperature of 36-42 degrees Celsius (i.e. body temperature), which is more comfortable to use, and can also be heated to between 42-45 degrees Celsius to achieve the effect of thermal therapy, soothing the pelvic floor muscle nerves and fascia tissues, and helping to improve the efficiency of pelvic floor repair.

The electrode three is a silicone electrode sheet, which is composed of a soft silicone sheet and a conductive hydrogel sheet, and has good softness and elasticity, which enables the electrode three to better fit the skin of the coccyx area of the human body and provide a comfortable treatment experience. The silicone electrode sheet will not cause irritation or discomfort to human tissue, provides good electrical conductivity, and is not easily damaged after long-term use. The cost of later consumables is low and the cost performance is high.

The present invention uses three electrodes, electrode one and electrode two are two perineal electrodes, and electrode three is a coccyx electrode, all of which are connected to a muscle/nerve stimulation electric pulse signal generating module. When in use, the positive and negative pole positions can be continuously switched, and they are constantly changing during use, which is not easy to cause fatigue and helps to improve the repair efficiency of muscles and nerves.

Furthermore, in the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device, the control system is a mobile phone, the mobile phone is provided with an APP software that matches the host, and the main control module is connected to the mobile phone via Bluetooth to realize information interaction between the host and the mobile phone. Compared with the design of setting the control interface on the host and controlling it through the touch screen in the prior art, the present invention can completely avoid the interference of the user's involuntary movement and the like on the use process through the smart phone APP.

For ease of use, a mobile phone is selected for control. The mobile phone has an APP software that matches the host. Through the APP software of the mobile phone, various parameters of the host can be adjusted to perform pelvic floor muscle and nerve electrical stimulation, pelvic floor muscle function assessment, biofeedback and other operations, and the operation status is transmitted to the mobile phone, helping users to better understand the treatment effect, greatly improving the convenience of use and the user's experience, and facilitating control and feeling of the treatment effect.

Furthermore, the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device integrates electrical stimulation and electromyographic biofeedback, and through the isolation circuit design, effectively avoids mutual interference between the two modules. The host also includes:

A power management module, which is used to supply power to the host;

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.

The main control module receives the parameter control input by the mobile phone APP software, controls the operation of the muscle/nerve stimulation electric pulse signal generation module and generates stimulation pulses. At the same time, the main control module can also collect the electromyographic signals collected by the electromyographic signal acquisition and processing module and transmit them to the mobile phone APP software via Bluetooth. The power management module supplies power to other modules of the host. The muscle/nerve stimulation electric pulse signal generation module generates electrical stimulation to the human body for treatment. The electromyographic signal acquisition and processing module receives and processes the electromyographic signals of the human body, including amplifying the electromyographic signals and removing the electromyographic signals generated by non-pelvic floor muscles to complete the biofeedback process. Since the electrical stimulation signal is strong and the electromyographic 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 sheet 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 be heated to 42-45 degrees Celsius to achieve the effect of auxiliary heat therapy.

Specifically: First, install the mobile phone with the APP software matching the host, turn on the Bluetooth working mode, query the paired Bluetooth device and successfully connect, and enable the APP software. The APP software mainly has functions such as electrical stimulation (muscle/nerve stimulation electric pulse signal generation module) and temperature control (heating module), electromyographic strength measurement (electromyographic signal acquisition and processing module) and functional evaluation, biofeedback training, etc. (1) Electrical stimulation and temperature control: The configuration of electrical stimulation parameters is mainly achieved by selecting the stimulation mode. Different stimulation modes have solidified a set of stimulation parameters. 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 time, etc. The intensity of the stimulation pulse, i.e., the voltage amplitude, can be flexibly adjusted by the user according to his or her tolerance in different stimulation modes. Regarding the temperature control of electrode 1 and electrode 2, the user can also make independent choices based on the ambient temperature and his or her own body sensation. (2) EMG intensity measurement and functional evaluation: The activation of the EMG signal acquisition and processing module is independent to avoid interference between the muscle/nerve stimulation pulse signal generation module and the EMG signal acquisition and processing module. Under the voice prompt of the APP software, the user contracts his or her perineum or performs exercises such as anal lifting to activate the pelvic floor muscles. The host collects the surface EMG transmitted to the body surface and completes the transmission attenuation loss compensation. Finally, it is transmitted to the mobile phone via wireless Bluetooth. The mobile phone makes a grade evaluation of the EMG function based on the strength of the EMG signal and gives feedback to the user to further understand the treatment effect. (3) Biofeedback training: The APP software can also realize biofeedback training. The mobile phone APP software reminds the user to contract the pelvic floor muscles through voice, and presents the trajectory of the pelvic floor muscle contraction 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 biofeedback training results. In short, the introduction of mobile phone APP software helps users better understand the treatment effects, greatly improves the ease of use and user experience, and facilitates the control and feeling of treatment effects.

Furthermore, the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device is designed with an electromyographic signal acquisition path compensation mechanism, which compensates for the attenuation of the pelvic floor electromyographic signal transmitted to the body surface according to the position of the external electrode and the depth of the contracted pelvic floor muscle, and can obtain more accurate pelvic floor electromyographic signals for biofeedback. The muscle/nerve stimulation electric pulse signal generation module includes a charge amplification module and an electrical signal output module, and the main control module, the charge amplification module, the electrical signal output module, and the non-invasive electrode sheet assembly are connected in sequence; the electromyographic 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, 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.

During electrical stimulation of the pelvic floor muscles and nerves, the main control module generates constant current stimulation pulses 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 perineum of the human body through electrode 1 and electrode 2, and to the coccyx of the human body through electrode 3.

When collecting human electromyographic signals, the electromyographic signals of the perineum and coccyx of the human body are collected through electrodes 1, 2, and 3, and the electromyographic signals are amplified through the electromyographic signal amplification module, that is, the low-pass filter module is first used for low-pass filtering to filter out the specific frequency higher than the setting to reduce the influence of the clutter signal, which can not only well preserve the electromyographic signal, but also reduce the interference of the power frequency in the collection process, and then the high-pass filter module is used for high-pass filtering. After passing through the low-pass filter circuit, the waveform higher than the cut-off frequency can be filtered out, and then the high-pass filter is used to filter out the signal lower than the cut-off frequency to ensure that the electromyographic signal is not distorted. After filtering the interference signal, it is amplified by the post-amplification circuit. The electromyographic signal compensation module establishes a compensation mechanism to compensate for the electromyographic signal lost during the transmission process, calculates its effective value and finally transmits it to the mobile phone, so that the user can detect and observe the treatment effect in real time.

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 assessment, and an implementation method of biofeedback.

Furthermore, the implementation method of the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device, the implementation method of the pelvic floor muscle and nerve electrical stimulation, comprises the following steps:

S12: Setting various parameters of pelvic floor muscle and nerve electrical stimulation through the mobile phone APP software, including but not limited to treatment duration, pulse width, pulse amplitude, and electrode temperature;

S13: The user is sitting on the host, ensuring that the electrode 1 and the electrode 2 correspond to the human perineum, and the electrode 1 and the electrode 2 are closely attached to the human perineum; ensuring that the electrode 3 corresponds to the human coccyx, and the electrode 3 is closely attached to the human coccyx;

S14: The host is powered on, and the pelvic floor muscle and nerve electrical stimulation is turned on through the mobile phone APP software. The silicone electrode directly contacts the human skin, so that the electrical stimulation signal is effectively transmitted to the pelvic floor muscle group;

S15: The user adjusts the electrical stimulation intensity of the host and the temperature of each electrode of the non-invasive electrode assembly through the APP software of the mobile phone according to his own experience;

S16: When one treatment cycle is over, the electrical stimulation of the pelvic floor muscles and nerves is stopped.

Furthermore, the implementation method of the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device and the implementation method of the pelvic floor muscle function assessment include the following steps:

S21: Choose a flat and hard place and place the host in a horizontal position;

S22: The user is sitting on the host, ensuring that the electrode 1 and the electrode 2 correspond to the human perineum, and the electrode 1 and the electrode 2 are closely attached to the human perineum; ensuring that the electrode 3 corresponds to the human coccyx, and the electrode 3 is closely attached to the human coccyx;

S23: The host is powered on to start the pelvic floor muscle function assessment or the pelvic floor muscle function assessment is performed after the pelvic floor muscle and nerve electrical stimulation;

S24: The mobile phone APP software 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 electromyographic signals at the same time;

S25: The collected electromyographic signal is amplified by the electromyographic signal amplification module, the electromyographic signal lost in the transmission process is compensated by the electromyographic signal compensation module, and the signal is converted into a digital signal that can be processed by the main control module through the ADC. The main control module calculates the effective value and transmits it to the mobile phone for display, and the pelvic floor muscle strength is functionally evaluated for the user's reference.

The electromyographic signals caused by the subjects' perineal contraction or anal levator movements were collected to evaluate the muscle strength and divide the energy intensity into different levels.

Furthermore, the implementation method of the above-mentioned non-invasive pelvic floor electrical stimulation and biofeedback device, the implementation method of the biofeedback, comprises the following steps:

S31: Choose a flat and hard place and place the host in a horizontal position;

S32: The user is sitting on the host, ensuring that the electrode 1 and the electrode 2 correspond to the human perineum, and the electrode 1 and the electrode 2 are closely attached to the human perineum; ensuring that the electrode 3 corresponds to the human coccyx, and the electrode 3 is closely attached to the human coccyx;

S33: Biofeedback is started after the host is powered on or after pelvic floor muscle and nerve electrical stimulation;

S34: The mobile phone APP software 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 electromyographic signals, and guides the user through the visual angle to reach the desired contraction strength and maintain it for a period of time;

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

S36: Repeat the above process according to the training program of the biofeedback mode set by the mobile phone APP software to achieve the effect of training the pelvic floor muscles through biofeedback.

The non-invasive electrode assembly is used to provide feedback on muscle contraction, and an exercise plan is provided based on the user's evaluation results to guide the subject to perform biofeedback rehabilitation training for the pelvic floor muscles to enhance the function of the pelvic floor muscles.

When implementing pelvic floor muscle electrical stimulation therapy, pelvic floor muscle function assessment, and biofeedback, the muscle/nerve stimulation electrical pulse signal generation module uses a combination of 4 low-frequency pulses with different frequencies (five frequency pulses: 20Hz, 30Hz, 50Hz, 80Hz, and 300Hz). Compared with a single frequency pulse, it is easier to repair neuromuscular tissue and can also prevent the increase in muscle tolerance caused by long-term electrical stimulation for 20 minutes.

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

(1) The non-invasive pelvic floor electrical stimulation and biofeedback device disclosed in the present invention has a reasonable design and achieves the technical purpose of improving the user's treatment experience and allowing the user to understand the treatment effect without affecting the stimulation effect and being able to collect effective electromyographic signals. It has the beneficial effects of being convenient and easy to use, improving comfort, ensuring treatment effects, and avoiding infection risks; 1. Convenient and easy to use, improving comfort: Compared with traditional pelvic floor muscle and nerve electrical stimulation instruments and methods, it adopts a non-invasive three-electrode design, 2 electrodes correspond to the human perineum, and 1 electrode corresponds to the human coccyx. It does not need to insert electrodes or probes, causing less damage. While ensuring the stimulation effect, it greatly improves the user's experience and reception. The user can perform the treatment at home by himself without the need for professional operation; 2. Ensure the treatment effect: Through the introduction of the third electrode in the coccyx area and the direct contact of the silicone electrode sheet with the human skin, the electrical stimulation signal is transmitted to the pelvic floor muscle group more directly and effectively, thereby ensuring and enhancing the treatment effect, and also making the electromyographic signal more directly transmitted, reducing the loss and weakening of the electromyographic signal, and providing real-time feedback on the treatment effect to the user; 3. Avoid infection risks: Each user can be equipped with an independent non-invasive electrode sheet assembly when using it, avoiding the cross-infection and hygiene problems that may be caused by the cross-use of electrodes by multiple people, and ensuring the safety and hygiene of the treatment; 4. Solve the problem of weak pelvic floor electromyographic signals collected by non-invasive electrodes;

(2) The implementation method of the non-invasive pelvic floor electrical stimulation and biofeedback device disclosed in the present invention is simple to operate, adjustable and highly flexible. Through the APP software of the mobile phone, various parameters of the host in different modes can be debugged to perform pelvic floor muscle and nerve electrical stimulation, pelvic floor muscle function assessment, biofeedback and other operations, and the operation status is transmitted to the mobile phone display screen, which helps users better understand the treatment effect, greatly improves the ease of use and the user's experience, and facilitates the control and feeling of the treatment effect.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG2 is a schematic diagram of the structure of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG3 is a schematic diagram of the structure of the mainframe housing of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG4 is a schematic diagram of the bottom of the main housing of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG5 is a schematic diagram of the metal electrode structure of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG6 is a schematic diagram of the structure of the PI heating plate of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG7 is a schematic diagram of the electrode structure of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG8 is a framework diagram of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG9 is a schematic diagram of a muscle/nerve stimulation electrical pulse signal generating module of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG10 is a schematic diagram of an electromyographic signal acquisition and processing module of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG11 is a schematic diagram of the transmission of pelvic floor electromyographic signals from the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention to various electrodes on the human body surface;

FIG12 is a schematic diagram of the electrode three of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention being located at the coccyx area of the body surface;

FIG13 is a comparison diagram of a conventional invasive two-electrode design (a) and an invasive three-electrode design (b) of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG14 is a cross-sectional view of the stimulation electric field distribution of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG15 is a three-dimensional diagram of the stimulation electric field distribution of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG16 is a schematic diagram showing attenuation of pelvic floor electromyographic signals of the non-invasive pelvic floor electrical stimulation and biofeedback device according to the present invention as the transmission distance increases;

FIG17 is a schematic diagram of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention compensating for pelvic floor electromyographic signals lost during transmission;

FIG18 is a schematic diagram of the effect of the pelvic floor electromyographic signal compensation mechanism of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

FIG19 is a diagram showing an actual test of the effect of the pelvic floor electromyographic signal compensation mechanism of the non-invasive pelvic floor electrical stimulation and biofeedback device of the present invention;

In the figure: host 1, host shell 11, upper shell 111, medical silicone pad 112, lower shell 113, non-slip silicone pad 114, non-invasive electrode sheet assembly 2, electrode one 21, metal electrode 211, PI heating sheet 212, electrode two 22, electrode three 23, silicone sheet 231, conductive hydrogel sheet 232, wire 233, control system 3, invasive electrode one c, invasive electrode two d.

Detailed ways

The following examples 1, 2, 3 and 4 are combined with specific experimental data and Figures 1-19 to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the protection scope of the present invention.

Embodiment 1 provides a non-invasive pelvic floor electrical stimulation and biofeedback device.

Example 1

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

As shown in Figures 1, 2, and 8, the host 1 integrates the functions of a pelvic floor muscle and nerve electrical stimulator and a biofeedback device, and the host 1 includes a host housing 11, a main control module, a muscle/nerve stimulation electrical pulse signal generating module, and an electromyographic signal acquisition and processing module. The non-invasive electrode sheet assembly 2 includes 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 upper left and right sides of the upper surface of the host housing 11 and are respectively connected to the muscle/nerve stimulation electrical pulse signal generating module and the 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 electrical pulse signal generating module and the electromyographic signal acquisition and processing module through a wire 233.

When in use, a person 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 control system 3 is a mobile phone, which is provided with an APP software that matches the host 1, and realizes information exchange between the host 1 and the mobile phone through Bluetooth.

Further, as shown in Fig. 3 and Fig. 4, the host housing 11 includes an upper housing 111, a medical silicone pad 112, a lower housing 113, and an anti-skid silicone pad 114. The upper surface of the upper housing 111 fits with the buttocks of the human body, and the upper surface of the upper housing 111 is provided with a medical silicone pad 112 where it contacts the ischium of the buttocks of the human body. The thickness of the medical silicone pad 112 is 5 mm, which improves the comfort of use. The electrode 1 21 and the electrode 2 22 are provided at the corresponding contact place of the upper surface of the upper housing 111 and the perineum of the human body. Since the host housing 11 has a certain tilt angle, the electrode 1 21 and the electrode 2 22 on the host housing 11 also have a suitable tilt angle, and the electrode 1 21 and the electrode 2 22 are protruding, so that they can better fit with the skin of the perineum of the human body. An anti-skid silicone pad 114 is provided at the bottom of the lower housing 113 to prevent the host 1 from sliding during use and affecting the use effect.

Further, as shown in FIG5 , the electrode 1 21 and the electrode 2 22 are metal electrodes 211 made of 316L stainless steel. 316L stainless steel is a highly corrosion-resistant material that can be used for a long time in a humid environment without being easily corroded, which enables the metal electrode 211 to maintain high stability and durability when in contact with human tissue and liquid, and also has good electrical conductivity, and can effectively transmit electrical stimulation. As shown in FIG6 , the PI heating plate 212 is a material with good insulation and high temperature resistance. Using it inside the metal electrode 211 can achieve heating of the metal electrode, which can make the electrode 1 21 and the electrode 2 22 have a constant temperature of 36-42 degrees Celsius (i.e., body temperature), which is more comfortable to use, and can also be heated to between 42-45 degrees Celsius to achieve the effect of thermal therapy, soothing the pelvic floor muscle nerves and fascia tissues, and helping to improve the efficiency of pelvic floor repair.

As shown in FIG7 , the electrode three 23 is composed of a soft silicone sheet 231 and a conductive hydrogel sheet 232, and has good softness and elasticity, which enables the electrode three 23 to better fit the skin of the coccyx of the human body and provide a comfortable treatment experience. The silicone electrode sheet does not cause irritation or discomfort to human tissue, provides good electrical conductivity, and is not easily damaged after long-term use. The cost of later consumables is low and the cost performance is high.

The present invention uses three electrodes, electrode one 21 and electrode two 22 are two perineal electrodes, and electrode three 23 is a coccyx electrode, all of which are connected to a muscle/nerve stimulation electric pulse signal generating module. When in use, the positive and negative pole positions can be continuously switched, and they are constantly changing during use, which is not easy to cause fatigue and helps to improve the repair efficiency of muscles and nerves.

Further, as shown in Fig. 8, the host 1 includes a main control module, a muscle/nerve stimulation electric pulse signal generating module, a power management module, an isolation circuit, a heating module, and an electromyographic 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 electric pulse signal generating module, and the main control module is connected to the electromyographic signal acquisition and processing module; the power management module, the power management module supplies power to other modules of the host 1, an isolation circuit is provided between the muscle/nerve stimulation electric pulse signal generating module and the electromyographic signal acquisition and processing module, the isolation circuit and the heating module are connected in sequence, and the heating module is connected to the electrodes in sequence.

Further, as shown in FIG9 , the muscle/nerve stimulation electric pulse signal generating module includes a charge amplification module and an electric signal output module, and the main control module (CPU), the charge amplification module, the electric signal output module, and the non-invasive electrode sheet assembly 2 are connected in sequence. When the pelvic floor muscles and nerves are electrically stimulated, the main control module (CPU) generates constant current stimulation pulses through the charge amplification module and the electric signal output module according to the electric stimulation parameters sent by the mobile phone APP software, and applies electric stimulation to the perineum of the human body through electrode 1 21 and electrode 2 22, and applies electric stimulation to the coccyx of the human body through electrode 3 23.

Electrode three 23 is located on the body surface of the coccyx as shown in FIG12. The design and introduction of electrode three 23 can well guide the electrical stimulation signal to the deep pelvic floor tissue. At the same time, the myoelectric signals of the deep pelvic floor muscles can also be effectively collected through electrode three 23. As shown in FIG13 (b), the present invention is designed to be a completely non-invasive electrode design, in which two electrodes (electrode one 21 and electrode two 22) are located on both sides of the perineum, and another electrode (electrode three 23) is located on the body surface of the coccyx. This design is completely different from the invasive electrode design located in the cavity (as shown in FIG13 (a), including invasive electrode one c and invasive electrode two d), which greatly improves the convenience and experience of the user. The present invention adopts a non-invasive three-electrode design. The introduction of the third electrode in the coccyx can effectively guide the electrical stimulation to the deep pelvic floor muscle group, and can achieve a stimulation effect similar to that of invasive electrical stimulation. At the same time, it is helpful to collect the myoelectric signals of the pelvic floor muscles. The distribution of the stimulation electric field is shown in FIGS. 14 and 15.

Further, as shown in Fig. 10, the electromyographic signal acquisition and processing module includes an electromyographic signal amplification module, an electromyographic signal compensation module, and an ADC, and the non-invasive electrode sheet assembly 2, the electromyographic signal amplification module, the electromyographic signal compensation module, the ADC, and the main control module (CPU) are connected in sequence. As shown in Fig. 11, when collecting human electromyographic signals, the electromyographic signals of the perineum and coccyx of the human body are collected through electrode 1 21, electrode 2 22, and electrode 3 23.

Furthermore, the electromyographic signal is amplified by the electromyographic signal amplification module, that is, the low-pass filtering module is first used for low-pass filtering to filter out the specific frequency higher than the setting to reduce the influence of the clutter signal, which can not only well preserve the electromyographic signal, but also reduce the interference of the power frequency in the acquisition process, and then the high-pass filtering module is used for high-pass filtering. After passing through the low-pass filtering circuit, the waveform higher than the cut-off frequency can be filtered out, and then the high-pass filtering is used to filter out the signal lower than the cut-off frequency to ensure that the electromyographic signal is not distorted. After filtering out the interference signal, it is amplified by the post-amplification circuit. The electromyographic signal compensation module establishes a compensation mechanism to compensate for the electromyographic signal lost during the transmission process, calculates its effective value and finally transmits it to the mobile phone, so that the user can detect and observe the treatment effect in real time.

Since the non-invasive electrodes are outside the body, they are farther away from the pelvic floor muscles than the invasive electrodes. Therefore, the pelvic floor electromyographic signals collected by the non-invasive electrodes are inevitably weaker than those of the invasive electrodes.

As shown in Figure 16-19, 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 signal emitted by the pelvic floor muscle decays exponentially with the increase of the transmission distance:

;

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:

.

Before performing pelvic floor muscle function assessment and biofeedback, the present invention first calculates the effective value of the collected compensated pelvic floor electromyographic signal. 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.

The non-invasive pelvic floor electrical stimulation and biofeedback device of Example 1 is used for treatment, which is a non-invasive treatment method that can improve the user's experience. Compared with traditional treatment methods, the non-invasive pelvic floor electrical stimulation and biofeedback device of Example 1 avoids cross-infection and hygiene problems that may be caused by cross-use of electrodes between multiple people. At the same time, the electrode 1 21 and the electrode 2 22 are installed and fixed on the host 1. This connection method is relatively simple and easy, and has good durability and reliability, reduces the movement of the electrode sheet, and maintains the stability of the treatment process.

Example 2 provides a method for implementing pelvic floor muscle and nerve electrical stimulation using the non-invasive pelvic floor electrical stimulation and biofeedback device of Example 1.

Example 2

As shown in FIGS. 1-19 , the implementation method of the pelvic floor muscle and nerve electrical stimulation of the non-invasive pelvic floor electrical stimulation and biofeedback device of Example 2 specifically includes the following steps:

S11: Select a flat and hard place and place the host 1 in a horizontal position;

S12: Setting various parameters of pelvic floor muscle and nerve electrical stimulation through the mobile phone APP software, including but not limited to treatment duration, pulse width, pulse amplitude, and electrode temperature;

S13: The user is sitting on the host 1, ensuring that the electrode 1 21 and the electrode 2 22 correspond to the human perineum, and the electrode 1 21 and the electrode 2 22 are closely attached to the perineum; ensuring that the electrode 3 23 corresponds to the coccyx of the human body, and the electrode 3 23 is closely attached to the coccyx;

S14: The host 1 is powered on, and the pelvic floor muscle and nerve electrical stimulation is turned on through the mobile phone APP software, and the non-invasive electrode sheet assembly 2 directly contacts the human skin, so that the electrical stimulation signal is effectively transmitted to the pelvic floor muscle group;

S15: The user adjusts the electrical stimulation intensity of the host 1 and the temperature of each electrode sheet 212 of the non-invasive electrode sheet assembly 2 through the APP software of the mobile phone according to his own experience;

S16: When one treatment cycle is over, the electrical stimulation of the pelvic floor muscles and nerves is stopped.

Example 3 provides an implementation method for evaluating pelvic floor muscle function using the non-invasive pelvic floor electrical stimulation and biofeedback device of Example 1.

Example 3

As shown in Figures 1-19, the implementation method of the non-invasive pelvic floor electrical stimulation and biofeedback device for pelvic floor muscle function assessment in Example 3 specifically includes the following steps:

S21: Select a flat and hard place and place the host 1 in a horizontal position;

S22: The user is sitting on the host 1, ensuring that the electrode 1 21 and the electrode 2 22 correspond to the human perineum, and the electrode 1 21 and the electrode 2 22 are closely attached to the perineum; ensuring that the electrode 3 23 corresponds to the coccyx of the human body, and the electrode 3 23 is closely attached to the coccyx;

S23: Turn off the implementation of pelvic floor muscle function assessment through mobile phone and conduct the implementation of pelvic floor muscle function assessment;

S24: The mobile phone APP software 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 electromyographic signals at the same time;

S25: The collected electromyographic signal is amplified by the electromyographic signal amplification module, the electromyographic signal lost in the transmission process is compensated by the electromyographic signal compensation module, and the signal is converted into a digital signal that can be processed by the main control module through the ADC. The main control module calculates the effective value and transmits it to the mobile phone for display, and the pelvic floor muscle strength is functionally evaluated for the user's reference.

Example 4 provides a method for implementing biofeedback using the non-invasive pelvic floor electrical stimulation and biofeedback device of Example 1.

Example 4

As shown in FIGS. 1-19 , the implementation method of the biofeedback of the non-invasive pelvic floor electrical stimulation and biofeedback device of Example 4 specifically includes the following steps:

S31: Select a flat and hard place and place the host 1 in a horizontal position;

S32: The user is sitting on the host 1, ensuring that the electrode 1 21 and the electrode 2 22 correspond to the human perineum, and the electrode 1 21 and the electrode 2 22 are closely attached to the perineum; ensuring that the electrode 3 23 corresponds to the coccyx of the human body, and the electrode 3 23 is closely attached to the coccyx;

S33: Implementation of biofeedback by turning off the pelvic floor muscle function assessment via mobile phone;

S34: The mobile phone APP software 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 electromyographic signals, and guides the user through the visual angle to reach the desired contraction strength and maintain it for a period of time;

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

S36: Repeat the above process according to the training program of the biofeedback mode set by the mobile phone APP software to achieve the effect of training the pelvic floor muscles through biofeedback.

The present invention has many specific application paths, and the above is only a preferred embodiment of the present invention. It should be pointed out that the above embodiments are only used to illustrate the present invention, and are not used to limit the protection scope of the present invention. For those of ordinary skill in the art, without departing from the principle of the present invention, several improvements can also be made, and these improvements should also be regarded as the protection scope of the present invention.

Claims (7)

1. A non-invasive pelvic floor electrical stimulation and biofeedback device, comprising: 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), and 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 arranged 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, and the electromyographic signal acquisition and processing module comprises an electromyographic signal amplification module, an electromyographic signal compensation module, and an ADC; 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 main housing (11) has an inclination angle of 0-20°, and the main 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 electrode 1 (21) and the electrode 2 (22) have the same structure, both comprising: 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 is characterized in that the control system (3) is a mobile phone, the mobile phone is provided with an APP software that matches the host (1), and the main control module is connected to the mobile phone via Bluetooth to realize 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, 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 is characterized in that the muscle/nerve stimulation electrical pulse signal generating module comprises a charge amplification module and an electrical signal output module, and the main control module, the charge amplification module, the electrical 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. 7. An implementation method of the non-invasive pelvic floor electrical stimulation and biofeedback device according to any one of claims 1 to 6, characterized in that it includes an implementation method of pelvic floor muscle and nerve electrical stimulation, an implementation method of pelvic floor muscle function assessment, and an implementation method of biofeedback.