CN116173404B

CN116173404B - In-vitro pelvic floor muscle electric stimulation instrument and electric stimulation method

Info

Publication number: CN116173404B
Application number: CN202211688520.7A
Authority: CN
Inventors: 朱兰; 顾翔宇; 张雪; 王晓辉
Original assignee: Guangzhou Huibo Information Technology Co ltd; Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Current assignee: Guangzhou Huibo Information Technology Co ltd; Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Priority date: 2022-12-27
Filing date: 2022-12-27
Publication date: 2024-01-30
Anticipated expiration: 2042-12-27
Also published as: CN116173404A

Abstract

An external pelvic floor myoelectric stimulator made of soft materials similar to sanitary napkins is attached to the vulva, so that sufficient contact and sufficient electric stimulation conduction are ensured, and meanwhile, myoelectric signals are accurately collected; while the pelvic floor muscles of the respective regions are electrically stimulated, not just the muscles of the individual regions. The hot compress is used for assisting, so that the muscle can be relaxed, the spasm can be relieved, and the pelvic pain can be improved. In addition, the invention can collect the electromyographic signals and give the suggestion of the frequency of the electric stimulation waveform to the user through signal analysis so as to increase the safety, convenience and effectiveness of the product. By means of the operation of the mobile terminal APP, different electric stimulation can be applied to muscle groups in different areas, and the same instrument can achieve personalized customization of pelvic floor muscle exercise and/or relaxation according to the requirements of different users.

Description

In-vitro pelvic floor muscle electric stimulation instrument and electric stimulation method

Technical Field

The invention relates to the technical field of medical equipment, in particular to an electric stimulation device and method for female pelvic floor muscles.

Background

The pelvic floor muscles of women are susceptible to injury, such as decreased muscle tone, from pregnancy or childbirth processes, resulting in relaxation of the pelvic floor tissue. And as women age, pelvic floor dysfunction diseases may be caused, severely affecting women's psychological and normal life.

Pelvic floor muscle electrical stimulation is a method for enhancing the pelvic floor muscle capacity by electrically stimulating pelvic floor muscle tissue with internal or external electrodes of the pudendum, vagina or anus. Pelvic floor electromyography is largely divided into three types, implantable, invasive and non-invasive, wherein an implantable electrode implants an electrode patch under the skin, an invasive electrode typically places the electrode in the pudendum or anus, and a non-invasive electrode places the electrode inside the skin surface or underwear.

The main electrical stimulation device at the bottom of the basin in the market mostly adopts invasive electrodes. Invasive electrodes are inconvenient to use and can cause discomfort to the user and even localized tissue damage due to the high intensity of current stimulation to surrounding tissue.

In recent years, a non-invasive pelvic floor muscle electric stimulation device has been developed, which improves comfort, and a conventional non-invasive electric stimulation device is composed of two external electrodes, wherein the current intensity of the non-invasive pelvic floor muscle electric stimulation device is weaker and unstable than that of the invasive pelvic floor muscle electric stimulation device, and the stimulation effect of the non-invasive pelvic floor muscle electric stimulation device is poor.

Disclosure of Invention

First, the technical problem to be solved

Aiming at the problems existing in the prior art, the invention provides an external pelvic floor muscle electric stimulator which adopts a non-invasive mode and simultaneously performs electric stimulation on pelvic floor muscles in all areas, thereby not only providing proper and stable electric stimulation, but also avoiding uncomfortable feeling.

(II) technical scheme

In order to achieve the above purpose, the main technical scheme adopted by the invention comprises the following steps:

an external pelvic floor flesh electricity stimulator, includes the rectangular slice body of soft rubber or silica gel, and its length covers pubic symphysis to the coccyx at least, sets up vagina electrode group, tendon center electrode group and labia electrode group on the upper surface of body, vagina electrode group sets up on the protruding cylinder of follow body upper surface protrusion for just be used for the flesh signal to gather, labia electrode group with tendon center electrode is used for applying the electric stimulus to labia bulbar cavernosum muscle, perineum center tendon and superficial transverse muscle respectively.

Preferably, an integrated control circuit is further arranged in the body, and the integrated control circuit comprises an electric stimulation pulse signal transmitting module, a Bluetooth signal transceiver, an electromyographic signal acquisition module, a controller, a rechargeable battery pack and a wireless charging module.

Preferably, the vaginal electrode set and the labial electrode set each include a pair of electrodes that are bilaterally symmetrical, and the tendon center electrode set includes two pairs of electrodes that are arrayed in a cross.

Preferably, the labial electrode set and the tendon central electrode set are also used for electromyographic signal acquisition.

Preferably, the electromyographic signal acquisition module is used for carrying out differential amplification on electromyographic signals acquired by the vaginal electrode group and the labial electrode group, and carrying out double differential amplification on the electromyographic signals acquired by the tendon central electrode group.

Preferably, the body comprises a two-layer structure, the upper layer is provided with a groove opening towards the upper surface of the upper layer, and the electrode is accommodated in the groove and protrudes out of the upper surface.

Preferably, a plurality of heating elements are disposed within the body.

Preferably, the body comprises a two-layer structure, a groove opening towards the upper layer is formed in the lower layer, and the heating element is accommodated in the groove.

Preferably, the mobile terminal is further connected with the electric stimulation pulse signal generating module in a wireless mode, and the mobile terminal sends control instructions to the electric stimulation pulse signal generating module and receives data transmitted by the electromyographic signal collecting module through the Bluetooth signal transceiver.

And a method for electrically stimulating pelvic floor muscles by means of the external pelvic floor muscle electric stimulation instrument, comprising the following steps:

collecting initial myoelectric signals of users, comparing the initial myoelectric signals with myoelectric signal level data of normal people, determining the types of myofibers to be exercised and/or relaxed, and generating recommended electric stimulation parameters aiming at muscles of different areas, wherein the electric stimulation parameters comprise electric stimulation frequency, waveform and on-off ratio;

and after applying electric stimulation for a certain time according to the recommended electric stimulation parameters, re-acquiring the electromyographic signals, and regenerating the recommended electric stimulation parameters based on the re-acquired electromyographic signal level, so that the recommended electric stimulation parameters are always matched with the requirements of the user.

(III) beneficial effects

The invention has the main technical effects that:

the invention is made of soft material similar to sanitary towel, which fully fits the vulva, ensures full contact and full electric stimulation conduction, and simultaneously accurately collects electromyographic signals; while the pelvic floor muscles of the respective regions are electrically stimulated, not just the muscles of the individual regions. The intra-vaginal myoelectricity information acquisition and in-vitro electric stimulation mode are combined, so that an ideal electric stimulation effect can be achieved, and user experience can be improved.

The hot compress is used for assisting, so that the muscle can be relaxed, the spasm can be relieved, and the pelvic pain can be improved. The invention can collect electromyographic signals and give suggestions to the frequency of the electric stimulation waveform to the user through signal analysis so as to increase the safety, convenience and effectiveness of the product.

By means of the operation of the mobile terminal APP, different electric stimulation can be applied to muscle groups in different areas, and the same instrument can achieve personalized customization of pelvic floor muscle exercise and/or relaxation according to the requirements of different users.

Drawings

The invention will be described in detail with reference to the following drawings:

FIG. 1 is a schematic diagram of the structure of the body of the external pelvic floor muscle electric stimulation instrument;

FIG. 2 is a schematic diagram of a control circuit of the external pelvic floor muscle electric stimulator according to the present invention;

fig. 3 is a data flow reference chart of the external pelvic floor muscle electric stimulator of the present invention.

Detailed Description

The invention will be better explained by means of a detailed description of the embodiments with reference to the drawings, for the sake of understanding.

Fig. 1 is a schematic structural view of an external pelvic floor muscle electric stimulator according to an embodiment of the present invention. An external pelvic floor muscle electrical stimulation apparatus of this embodiment includes: the body 10, which is an elongated sheet of soft rubber or silicone like an elongated sanitary napkin, the length of the body 10 is capable of covering the pubic symphysis to the coccyx. The shape of the upper surface of the body 10 is designed to be complementary to the female vulva according to the average modeling to ensure the fitting with the skin and mucous membrane as much as possible.

The columnar protrusion 11 with the height of 4-5cm is arranged at the joint of the body 10 and the vaginal orifice, the tail end is rounded, the material is preferably soft rubber or silica gel, and the electrode is arranged on the columnar protrusion, and the columnar protrusion is also used for being inserted into the vaginal orifice in use so as to avoid the body 10 from moving back and forth and left and right undesirably in use, and the interference caused by friction in electromyographic signals is reduced. By means of daily wear, a more stable positioning of the body 10 relative to the body is achieved.

The soft rubber or silicone material of the body 10 includes an upper layer 10a and a lower layer 10b, and one layer for fitting the pudendum is referred to as an upper layer 10a and the outer surface thereof is referred to as an upper surface. Correspondingly, the layer facing the garment is referred to as the lower layer 10b, and the outer surface thereof is referred to as the lower surface.

A plurality of electrodes are arranged in the upper layer 10a of the body 10, and preferably, each electrode is arranged in a groove which is opened towards the upper surface on the upper layer rubber or silica gel material, and the rear surface of the electrode is placed in the groove to protrude from the upper surface of the body 10 by 0.5-1mm. The bottom of the recess is provided with a hole through which a power supply passes to connect the electrode with a circuit module mounted in the lower layer 10b of the body 10. Preferably, a sealing material is provided at the bottom of the recess to prevent moisture from entering between the upper and lower layers from the gap between the electrode and the recess.

In this embodiment, the body comprises at least the following electrodes or electrode groups: the vagina electrode group 12 comprises a pair of electrodes symmetrically arranged on the surface of the small protrusion 11, and when the body is attached to the vulva and is arranged in place, the small protrusion 11 is placed into the vagina so that the vagina electrode group can be attached to the inner wall of the vagina; a tendon center electrode group 13 including two pairs of electrodes arranged in a cross shape, the tendon center electrode group 13 being capable of fitting the perineum center tendon when the small protrusion 11 is properly placed in the vagina; the labial electrode assembly 14 includes a pair of electrodes arranged in bilateral symmetry, and the labial electrode assembly 14 can be attached to both sides of the mid-labia minora when the tab 11 is properly placed in the vagina.

A plurality of heating elements 15 are arranged in the lower layer 10b of the body 10, preferably, the heating elements are arranged in grooves which are formed in the lower layer rubber or silica gel material and open towards the upper layer, and the heating elements are flush with the upper surface of the lower layer 10b after being placed in the grooves. The heating element is preferably a sheet, such as a rare earth thick film circuit heating element selected for appropriate power. In a preferred embodiment, the heating element is a constant temperature heating element, the temperature is set to 40-50 ℃, and the heating element provides warmth and avoids local low-temperature scalding. The heating elements comprise at least two, wherein a first heating element 151 is arranged at the coccyx and a second heating element 152 is arranged at the pubic symphysis. In a preferred embodiment, the device further comprises a third heating element (not shown) arranged at the middle section of the body 10 and avoiding the position of the electrode.

Two sides of the body 10 are respectively provided with a sheet clip which is turned outwards and is used for fixing the stimulator on the underwear.

The lower layer 10b of the body 10 is further provided with a groove 16 for accommodating the integrated control circuit, for example, disposed at the tail of the body 10 and behind the first heating element. The opening of the recess 16 is closed towards the upper layer 10a, preferably towards the side of the outer surface of the lower layer, for protecting the circuit module arranged in the recess. The body tail where the groove 16 is located can be designed to be wider and thicker to provide sufficient groove interior space. The wider and thicker tail part of the body does not affect walking and sitting rest in the wearing and using process.

Preferably, after the upper layer and the lower layer are installed, the periphery forms a complete sealed shell by means of sealing materials and/or structures, so that the water-washable structure is realized.

As shown in fig. 2, the integrated control circuit includes an electrical stimulation pulse signal transmitting module, a bluetooth signal transceiver, an electromyographic signal acquisition module, a controller, a rechargeable battery pack and a wireless charging module.

The bluetooth signal transceiver is used for being connected with mobile terminal equipment such as cell-phone, and with the help of cell-phone APP, receive, send data and control operation, control the state of group battery to electric stimulation pulse signal transmitting module, myoelectric signal acquisition module, heating element 15.

The electric stimulation pulse signal is used for sending out an electric stimulation pulse signal, contains information such as waveform, frequency and the like, and enables the electrode to generate pulse stimulation to pelvic floor muscles. The performed electrical stimulation pulse signal data and the generated electromyographic signal data are stored in the mobile terminal.

The electromyographic signal acquisition module is connected with the electrode plates by means of a differential amplification circuit and a filter circuit, so that the electromyographic signals acquired by the vagina electrode group 12 and the labia electrode group 14 are subjected to differential amplification, and the electromyographic signals near the tendon center electrode group 13 are subjected to double differential amplification. The arrangement mode of each electrode group adopts the arrangement distance of minimized noise after differential or double differential. The electromyographic signal acquisition module comprises a filtering sub-module which performs high-frequency filtering and low-frequency filtering according to the physiological characteristics of the electromyographic signals so as to reduce noise in the electromyographic signals.

In an embodiment of the present invention, the method for electrical stimulation using the aforementioned external pelvic floor electrical stimulation apparatus is further included, and the data flow is referred to in fig. 3.

First, user-initiated electromyographic signals are acquired using a vaginal electrode set, a tendon central electrode set, and/or an labial electrode set, and stored in a user database.

The electromyographic signal collection is completed at least by the vaginal electrode group, and the electromyographic signal collected by the vaginal electrode group can reflect the integral state of pelvic floor muscles. Alternatively, the electromyographic signal acquisition by the tendon central electrode group and/or the labial electrode group can be added, and the state of different pelvic floor muscle areas can be reflected by multi-point acquisition.

And then comparing the signal level of the user with the electromyographic signal level data of the normal population, determining the type of muscle fiber to be exercised and/or relaxed, and generating recommended data of the electrical stimulation parameters, including electrical stimulation frequency, waveform and on-off ratio.

Normal population refers to population without subjective pelvic floor symptoms, and various physical characteristics including age, weight, whether the normal population is a menstruum or not and the like need to be calibrated, and the normal population is grouped according to the difference significance of myoelectric data. And according to various characteristics of the user body, the standard pairs are correspondingly grouped into normal groups.

Also, different recommended electrical stimulation parameters may be generated for different regional muscles depending on the type and region of muscle fibers that the user himself needs to exercise and/or relax. The tendon center electrode set and/or the labial electrode set apply electrical stimulation to the pelvic floor muscles of different regions based on the recommended electrical stimulation parameters. The recommended electrical stimulation parameters for the tendon central electrode set and the labial electrode set may be different.

After the electrical stimulation is applied according to the recommended electrical stimulation parameters, the generated electromyographic signals are collected, filtered through hardware, processed in software and stored in a user database.

After a period of treatment, the myoelectric signal level will change, then based on the latest myoelectric signal level, a new recommended electrical stimulation parameter is generated by comparing with the normal population, and the tendon center electrode group and/or the labia electrode group apply electrical stimulation based on the new recommended electrical stimulation parameter, so as to achieve the optimal electrical stimulation effect.

Finally, by comparing the electromyographic signals with the electromyographic signal levels in the earlier stage of the user, the user can see the improvement of the signal levels and evaluate the effect of the electrical stimulation process on pelvic floor muscle repair based on the improvement.

When the intelligent myoelectricity acquisition device is used, the constant temperature heating element is firstly turned on, and the mobile terminal prompts a user to acquire an initial myoelectricity 5 signal. The mobile terminal (APP) provides the user selectable electrical stimulation frequency, waveform and on-off ratio interval options according to the initial electromyographic signal condition of the user.

The user starts after selecting in APP operation, performs electric stimulation, collects electromyographic signal data, and the obtained data can be checked on a mobile phone of terminal equipment for the user to detect the action and effect of the stimulator.

0 the external basin bottom electric stimulator of the invention adopts soft material in the form of sanitary towel

The device is made from pubic symphysis to cover the tail bone, can fully fit with the vulva, cover pelvic floor muscles in a plurality of areas, fully contact with the pelvic floor muscles and ensure electric stimulation conduction. The hot compress is used for assisting, so that the muscle can be relaxed, the spasm can be relieved, and the pelvic pain can be improved.

The pelvic floor muscles of each region may be electrically stimulated simultaneously, not just to the muscle 5 flesh of the individual region. By means of operation of the mobile terminal APP, different electric stimulation can be applied to muscle groups in different areas, and the same instrument can achieve pelvic floor muscle exercise and +.

Or relaxed personalized customization.

In addition, the invention can collect the electromyographic signals and give the suggestion of the frequency of the electric stimulation waveform to the user through signal analysis so as to increase the safety, convenience and effectiveness of the product.

0 finally, it should be stated that: the above embodiments are only for illustrating the technical scheme of the present invention

Not limited thereto; although the invention has been described in detail with reference to the foregoing examples, it will be understood by those of ordinary skill in the art that: the technical scheme recorded in the previous examples can be modified or some or all technical features in the technical scheme can be replaced equivalently; and this

Such modifications and substitutions do not depart from the essence of the corresponding technical solutions from the scope of technical solution 5 of each embodiment of the present invention.

Claims

1. An external pelvic floor muscle electric stimulation instrument is characterized by comprising a strip-shaped platy body in a sanitary towel shape of soft rubber or silica gel, wherein the length of the strip-shaped platy body at least covers pubic symphysis to tail bones, a vaginal electrode group, a tendon center electrode group and a labia electrode group are arranged on the upper surface of the body, the vaginal electrode group is arranged on a cylindrical protrusion protruding from the upper surface of the body and is used for collecting only electromyographic signals, the height of the cylindrical protrusion is 4-5cm, the cylindrical protrusion is placed into vagina when the body is fitted with a vulva, so that the vaginal electrode group can be fitted with the inner wall of the vagina, and the labia electrode group and the tendon center electrode are used for applying electric stimulation to the labia globus cavernosus muscle, the perineal center tendon and the superficial transverse muscle respectively;

the vagina electrode group is used for collecting initial myoelectric signals of users, comparing the initial myoelectric signals with myoelectric signal level data of normal people, determining the type of myofibers which need to be exercised and/or relaxed, and generating recommended electric stimulation parameters aiming at muscles of different areas, wherein the electric stimulation parameters comprise electric stimulation frequency, waveform and on-off ratio;

the vaginal electrode group is also used for re-collecting the electromyographic signals after applying the electrical stimulation for a certain time according to the recommended electrical stimulation parameters, and re-generating the recommended electrical stimulation parameters based on the re-collected electromyographic signal level, so that the recommended electrical stimulation parameters are always matched with the requirements of users.

2. The external pelvic floor myoelectric stimulation instrument according to claim 1, wherein the body is further provided with an integrated control circuit, and the integrated control circuit comprises an electric stimulation pulse signal transmitting module, a Bluetooth signal receiving and releasing device, a myoelectric signal collecting module, a controller, a rechargeable battery pack and a wireless charging module.

3. The external pelvic floor electromyography apparatus of claim 2, wherein the vaginal electrode group and the labial electrode group each comprise a pair of electrodes which are bilaterally symmetrical, and the tendon center electrode group comprises two pairs of electrodes which are arranged in a cross.

4. The external pelvic floor electromyography apparatus of claim 3, wherein said labial electrode assembly and said tendon central electrode assembly are further used for electromyographic signal acquisition.

5. The external pelvic floor muscle electrical stimulation apparatus according to claim 4, wherein,

the myoelectric signal acquisition module is used for carrying out differential amplification on the myoelectric signals acquired by the vagina electrode group and the labia electrode group and carrying out double differential amplification on the myoelectric signals acquired by the tendon center electrode group.

6. The external pelvic floor electromyography apparatus according to claim 3, wherein said body comprises a two-layer structure, a groove opening toward an upper surface thereof is formed in an upper layer, and said electrode is accommodated in said groove and protrudes from said upper surface.

7. The external pelvic floor muscle electrical stimulation apparatus of claim 2, wherein a plurality of heating elements are disposed within the body.

8. The external pelvic floor muscle electrical stimulation apparatus according to claim 7, wherein the body comprises a two-layer structure, the lower layer is provided with a groove opening towards the upper layer, and the heating element is accommodated in the groove.

9. The external pelvic floor myoelectric stimulation instrument according to claim 2, further comprising a mobile terminal in wireless connection, wherein the mobile terminal sends control instructions to the electric stimulation pulse signal generation module by means of the Bluetooth signal transceiver and receives data transmitted by the myoelectric signal acquisition module.