A pelvic floor muscle training system

Abstract

The present invention relates to a pelvic floor muscle training system and method, comprising: an electromyographic signal detection module, detecting the dynamically changing electromyographic signals of the pelvic floor muscle group and the rectus abdominis muscle of the user, including the pubovaginal muscle or the puborectalis muscle; and an electrical stimulation module, comprising electrodes arranged in the anus or vagina of the user to provide muscle electrical stimulation energy. When the electromyographic signal detected by the electromyographic signal detection module reflects that the user performs an anal lifting action, the Kegel training module provides resistance to the contraction of the pubovaginal muscle or the puborectalis muscle of the user performing the anal lifting action, and the resistance can change dynamically based on the electromyographic signal parameters of the pubovaginal muscle or the puborectalis muscle of the user. After completing a stage of passive exercise, the user can complete the Kegel training while maintaining the feeling of the electrical stimulation site, thereby achieving the purpose of relieving muscle soreness.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a pelvic floor muscle training system. Background Art

[0002] Vaginal relaxation syndrome (VRS), commonly referred to as "vaginal looseness," is a fairly common medical condition. "Vaginal looseness" is described as the loss of optimal vaginal architecture, which is often associated with vaginal childbirth and natural aging. Multiple pregnancies and menopause are the main causes of VSR, which causes a drop in female hormone levels and vaginal atrophy.

[0003] There are a variety of VRS treatment options on the market, including behavioral exercises (Kegel exercises), medications (hormones, firming creams or sprays), and various invasive surgical procedures.

[0004] The Chinese patent with patent number CN111773259B discloses a botanical hydrogel preparation for repairing vaginal mucosal damage, comprising the following components in mass percentage: 9.39-15.21% of glucomannan, 0.94-1.52% of asiatica glycoside, 75.08-81.14% of cnidium monnieri distillate, 0.04-0.06% of chlorhexidine acetate, 1.22-1.52% of carbomer-934, 4.22-6.11% of glycerol, and 1.65-2.01% of triethanolamine, and the sum of the mass percentages of the above components is 100%. The above botanical hydrogel preparation is prepared by mixing the ingredients of each component, stirring and dissolving, adjusting the pH, and potting and sterilizing; the invention has multiple pharmacological effects such as repairing mucosal tissue, improving the vaginal defense barrier, and antibacterial and anti-inflammatory. The Chinese patent with patent number CN103301567B provides a therapeutic device for repairing female vaginal tissue. The therapeutic device includes a therapeutic head. The shape of the end of the therapeutic head can be conical, spherical, hemispherical, elliptical or circular, and includes one or more heat transfer plates. The heat transfer plates can cool the surface cells of the vagina and simultaneously transmit energy to heat the tissue under the surface cells.

[0005] Although behavioral and drug treatments are non-invasive and safe, their efficacy is limited. In order to achieve the purpose of vaginal tightening or vaginal repair, some people will choose invasive surgery. Whether it is invasive surgery or simple application of drugs, it is impossible to activate the muscles of the pelvic floor muscles to maintain the contraction effect of the vagina or rectum, especially for vaginal or rectal relaxation caused by postpartum pelvic floor muscle damage. The pelvic floor muscles refer to the muscle group that closes the pelvic floor. This muscle group is like a "hanging net". The urethra, bladder, vagina, uterus, rectum and other organs are tightly suspended by this "net" to maintain their normal position in order to perform their functions. Once the elasticity of this "net" deteriorates and the "hanging force" is insufficient, the organs in the "net" will not be able to maintain their normal position, resulting in corresponding functional disorders, such as incontinence and pelvic organ prolapse. Even if the vagina or rectum is restored to normal by external force, due to the relaxation of the pelvic floor muscles, the uterus, vagina or rectum may suffer from secondary dislocation, relaxation and other problems, and the prognosis is still not ideal.

[0006] The Chinese patent with the patent number CN111297355B provides a biofeedback device for pelvic floor muscle rehabilitation training, including a biofeedback device body, the biofeedback device body includes an electrode sheet, a main control board, a shell and a power supply assembly, and the electrode sheet includes a plurality of acquisition electrode sheets and a plurality of stimulation electrode sheets. The present invention also relates to a biofeedback system for pelvic floor muscle rehabilitation training. The present invention uses a piezoelectric acquisition electrode sheet made of a pressure sensing material to collect pelvic floor muscle strength signals, and performs electrical stimulation through a stimulation electrode. It has both pelvic floor muscle strength signal acquisition function and electrical stimulation function. The two realize closed-loop stimulation of the pelvic floor muscles through an algorithm. The main control unit analyzes the collected signal and provides feedback on the stimulation mode.

[0007] Since the patient's muscle strength changes do not occur in the short term and need to be coordinated with the patient's autonomous pelvic floor muscle training, the system that generates electrical stimulation based on the feedback of muscle strength signals will not change significantly during actual use. However, in actual practice, long-term uninterrupted electrical stimulation will cause greater stimulation to the user's sensitive vagina or rectum. Even after a long period of electrical stimulation, the user's private parts will still feel tingling or itching. Based on this, the present invention provides a pelvic floor muscle training system.

[0008] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology. Summary of the invention

[0009] The pelvic floor muscles are the most important muscle group that affects the tightness of the human vagina and rectum. The relaxation of the pelvic floor muscles is also the main factor that causes the relaxation of the human vagina and rectum, leading to urinary incontinence, gynecological inflammation and other diseases. In the prior art, when the pelvic floor muscles are found to be loose and affect people's normal life and physiological activities, it is necessary to improve the elasticity and tightness of the pelvic floor muscles through various treatment methods, including electrical stimulation, self-training and pressure ball compression. At present, the most widely used treatment method is the combined treatment of electrical stimulation and self-training, specifically: electrical stimulation of the vagina or rectum every other day, daily anal lifting training according to the doctor's advice, and long-term persistence for at least 1 month. The main purpose of muscle electrical stimulation (EMS) is to activate and exercise motor muscle fibers; the main purpose of functional electrical stimulation (FES) is to compensate for damaged muscle tissue, and to compensate for the function of damaged tissue through the effect of electrical stimulation; neuromuscular electrical stimulation (NMES) refers to the use of low-frequency pulse current to stimulate nerves or muscles, cause muscle contraction, and improve muscle function to treat neuromuscular diseases. The pelvic floor muscle group includes the puborectalis muscle, pubovaginal muscle, pubococcygeus muscle and other tissues. Among them, the positions where the electrode can directly act during the electrical stimulation process are the puborectalis muscle and puborectalis muscle, that is, the electrode can directly provide muscle electrical stimulation energy to the puborectalis muscle and puborectalis muscle. The contraction of the puborectalis muscle and puborectalis muscle drives the contraction of other surrounding muscle groups, thereby achieving the purpose of exercising the entire pelvic floor muscle.

[0010] In the actual treatment process, it was found that when the user receives electrical stimulation, the part that is in contact with the electrode for a long time will experience itching and tingling during and after the electrical stimulation, and this feeling is also one of the reasons that seriously affect the user's subsequent adherence to treatment. At the same time, when the user returns home to exercise on his own, he cannot correctly perceive the exercise area, and mistakenly uses muscles other than the pelvic floor muscles to achieve the feeling described by the medical staff. After long-term exercise, not only may the treatment effect not be achieved, but the patient's muscle groups may also be strained and other effects may be caused. The above results seriously affect the user's confidence in persisting in completing the treatment, and may even make the user doubt the effectiveness of the treatment.

[0011] The present invention provides a pelvic floor muscle training system, comprising an electromyographic signal detection module and an electrical stimulation module.

[0012] The electromyographic signal detection module detects the dynamically changing electromyographic signal parameters of the user's pelvic floor muscle group located at the perineum and the rectus abdominis muscle located at the abdomen, and obtains the dynamically changing electromyographic signal parameters of the user's pelvic floor muscle group including the pubovaginal muscle or the puborectalis muscle and the rectus abdominis muscle.

[0013] The electrical stimulation module includes electrodes, which are arranged at the anus or vagina of the user to provide muscle electrical stimulation energy to the anus or vagina of the user.

[0014] The system also includes a Kegel training module. When the myoelectric signal parameters detected by the myoelectric signal detection module reflect that the user performs an anal lifting action, the Kegel training module provides resistance to the contraction of the pubovaginal muscle or the puborectalis muscle of the user performing the anal lifting action. The resistance can change dynamically based on the myoelectric signal parameters of the pubovaginal muscle or the puborectalis muscle of the user.

[0015] The system further comprises a control unit configured to cross-control a switch of the muscle electrical stimulation energy delivered by the electrical stimulation module and a switch of the resistance delivered by the Kegel training module.

[0016] Preferably, the electromyographic signal detection module in the present application can generate electromyographic signal parameters for judging the strength of the user's pelvic floor muscle group based on each contraction of the user's pelvic floor muscle group, and the control unit can generate resistance parameters for resisting the contraction of the user's pelvic floor muscle group based on the electromyographic signal parameters of each maximum vaginal contraction, and the Kegel training module can generate the amount of gas filled into its air bag based on the resistance parameter. Preferably, the pelvic floor muscle group can refer to the puborectalis muscle and the pubovaginal muscle.

[0017] Beneficial effects of this technical solution:

[0018] 1. Customize the training effect based on the user's pelvic floor muscle group status: When there is no resistance in the vagina, the user is not clear about the degree to which the pelvic floor muscle group contracts to achieve the training effect. In particular, when the user's pelvic floor muscle group is strengthened based on long-term exercise, if the user still maintains the previous exercise intensity, the strengthened pelvic floor muscle group cannot be exercised with the same intensity. The present application can provide resistance for resisting the contraction of the pelvic floor muscle group to achieve the purpose of exercising the pelvic floor muscle group based on the real-time changing pelvic floor muscle group strength. On the one hand, this setting can be set for the pelvic floor muscle group of different states of different individuals. On the other hand, it can also gradually increase the resistance with the degree of repair of the individual's pelvic floor muscle group, so that the training effect will not weaken with the repair of the pelvic floor muscle group.

[0019] 2. Kegel exercise refers to an exercise method that exercises the pelvic floor muscles located at the pubic bone and coccyx by applying force to the pelvic floor muscles. This exercise method can prevent the user from using muscles in other parts of the body to apply force to complete repeated contraction and relaxation movements. After the first component of the Kegel training module enters the human body, it tends to slip out of the vagina or rectum due to its own weight. The user needs to control the contraction of their own pelvic floor muscles and keep the first component in the vagina or rectum. After that, gradually release the force, rest, and repeat the process of tightening the muscles to prevent the first component from falling off again. During use, in order to prevent the first component from falling off, the patient may use inappropriate muscle groups to achieve the purpose. The electrical stimulation module is used to stimulate the pelvic floor muscle groups to induce muscle contraction, while enabling the user to correctly perceive the electrical movement area. The electromyographic signal detection module detects the user's abdomen, allowing the user to use the correct muscle groups to complete the action (especially avoiding the vaginal tightening effect caused by the non-pelvic floor muscle groups, for example, the rectus abdominis muscle is used to achieve the vaginal tightening effect), providing correct force guidance, thereby achieving accurate and efficient exercise.

[0020] 3. This application proposes a new mode of exercising the pelvic floor muscles, that is, the alternation of voluntary muscle contraction under nerve control and contraction under electrical stimulation. Based on the exercise method under this mode, on the one hand, this mode can relieve the itching sensation caused by electrical stimulation to the vagina; on the other hand, this mode can also ensure that the user correctly remembers the force position after electrical stimulation, so that the user can perform correct exercise behavior when exercising on his own.

[0021] According to a preferred embodiment, the cross control refers to:

[0022] Based on the electromyographic signal parameters related to the pubovaginal muscle or the puborectalis muscle provided by the electromyographic signal detection module, the control unit can send a signal to terminate the current to the electrical stimulation module when the frequency domain characteristics of the electromyographic signal parameters change significantly, wherein the pubovaginal muscle or the puborectalis muscle is in a state of receiving muscle electrical stimulation energy transmitted by the electrical stimulation module; in response to the electrical stimulation module terminating the sending of current, the prompting unit prompts the user to perform anal levator movements under neural control; the Kegel training module generates a resistance training process including anal levator movements based on the electromyographic signal parameters related to the fast muscles of the pubovaginal muscle or the puborectalis muscle of the user transmitted by the electromyographic signal detection module; in response to the completion of the resistance training process, the control unit controls the electrical stimulation module to start working.

[0023] According to a preferred embodiment, when the electrical stimulation module stops sending current, the control unit can also control the electromyographic signal detection module to detect the user's rectus abdominis. The pelvic floor muscles under electrical stimulation do not require the user to allocate strength to contract the pelvic floor muscles. When the user's muscles voluntarily contract under the control of nerves, the possibility of the rectus abdominis driving the pelvic floor muscles to contract the vagina or rectum is greatly enhanced. On this basis, when the user is in a situation where he needs to exercise his pelvic floor muscles independently, and the electromyographic signal parameters provided by the electromyographic signal detection module of the rectus abdominis exceed the first threshold, the data of this contraction will not be counted by the Kegel training module. Preferably, the first threshold can be between 60 and 280 μv. Preferably, in this application, AEMG is used to collect the electromyographic signal parameters of the rectus abdominis. In this application, SEMG is used to collect the electromyographic signal parameters of the pelvic floor muscles.

[0024] According to a preferred embodiment, the frequency domain characteristics of the electromyographic signal parameters that characterize the fatigue state of the pubovaginal muscle or puborectalis muscle are changed as follows: the median power frequency (MDF) is significantly reduced and the root mean square amplitude (RMS) is significantly increased. MDF refers to the average value of the electromyographic signal parameter frequency during this period of time.

[0025] Preferably, the significant reduction in MDF is quantitatively described as:

[0026] The amplitude change rate of MDF is negative.

[0027] Preferably, the quantitative description of the significant increase in RMS is:

[0028] The RMS amplitude change rate is positive.

[0029] Beneficial effects of this technical solution:

[0030] (1) In the cross-operation of the electrical stimulation module and the Kegel training module, the switching timing between the two is one of the main factors affecting the user's exercise effect.

[0031] Generally speaking, electrical stimulation of the pelvic floor muscles is a passive exercise, while the user's voluntary contraction of the pelvic floor muscles is an active exercise. In the treatment process of restoring the strength of the pelvic floor muscles, active and passive exercises need to be performed together. "The Effect of Kegel Exercises Combined with Biofeedback Electrical Stimulation on Postpartum Pelvic Floor Rehabilitation Management" proposes that Kegel exercises combined with biofeedback electrical stimulation can promote pelvic floor muscle strength, improve urinary incontinence, pelvic organ prolapse and other pelvic floor abnormalities, and improve the quality of sexual life of patients. However, in the prior art, autonomous exercises of the pelvic floor muscle strength need to be performed privately by the user.

[0032] During electrical stimulation therapy, long-term passive stimulation has little effect on promoting the user's motor function, improving motor ability and reducing postural tension, and will cause the patient to lose motor function and motor ability in the long run; excessive expansion of muscle activity will reduce the patient's control ability, that is, when the user needs to rely on his or her own nerves to control the pelvic floor muscles to complete the contraction of the corresponding private parts, even if the private parts have the ability to contract, the user cannot control their contraction. At the same time, the muscle activity parts controlled by the user need to match the muscle activity parts of passive exercise. The parts directly stimulated by electricity and related to the exercise of the pelvic floor muscles are rich in blood vessels and are easily affected by electrical stimulation to produce vasodilation problems. Under a single long-term electrical stimulation (for example, 1 hour), this part will produce a feeling of distension, itching, or even numbness. When users go home and exercise this part on their own, on the one hand, the numb private parts cannot be accurately sensed, making it impossible to perform the exercise under the control of the nerves normally, and even the exercise will bring more intense discomfort; on the other hand, incorrect exercise methods will also reduce the effect of the exercise, including but not limited to using the rectus abdominis instead of the pelvic floor muscles to drive the contraction of the vagina / anus, and insufficient contraction of the pelvic floor muscles.

[0033] This technical solution uses electrical stimulation to increase muscle contraction, and then detects the muscle contraction signal of the pelvic floor muscle group, and confirms the timing of switching to autonomous exercise based on the fatigue signal of the pelvic floor muscle group, so that passive exercise and active exercise are performed alternately, so that autonomous exercise and passive exercise can be completed at the same time under detection.

[0034] When muscle strength reaches its limit, it means that the muscle enters a fatigue state. If the muscles in a fatigued state are still exercised at the current passive exercise frequency, it will cause muscle soreness, weakness, or even strain, which will also affect subsequent autonomous exercise. When the muscle strength has reached its limit based on muscle strength detection, the system can automatically switch from passive exercise to active exercise. Users in autonomous exercise can rely on their perception of their own muscles to produce the following advantages for muscles in a fatigued state:

[0035] 1. After completing a stage of passive exercise, the user completes Kegel training while maintaining the feeling of the electrical stimulation area, thereby achieving the purpose of relieving muscle tingling or soreness.

[0036] 2. Under electrical stimulation, the user's memory of the muscle positions for passive exercise is clearest. After completing a stage of passive exercise, in the subsequent independent exercise process, the user uses the correct parts for exercise based on memory, thereby improving the accuracy of the exercise position.

[0037] 3. Passive exercise and active exercise are carried out alternately. The user's movement control of the pelvic floor muscles can match the growth of the pelvic floor muscle strength, thereby alleviating the difficulties that the user needs to overcome in deploying muscles during active exercise.

[0038] According to a preferred embodiment, the Kegel training module comprises at least a first component arranged in the vagina or rectum of the user and an airflow control component connected to the first component and capable of providing gas to the first component and controlled by the control unit, wherein the first component comprises an airbag and a pressure sensitive element mounted on the outer surface of the airbag. The inflated airbag can both support the device in the vagina to prevent it from slipping out and increase the pressure on the vagina / rectum. The electrode sheet for stimulating the pelvic floor muscles is arranged on the surface of the airbag.

[0039] According to a preferred embodiment, based on the electrical stimulation module stopping sending current and the electromyographic signal detection module detecting that the patient's pubovaginal muscle or puborectalis muscle begins to contract, the Kegel training module obtains the dynamic pressure value of the pubovaginal muscle or puborectalis muscle based on the pressure sensitive element provided on the outer surface of its airbag when the user performs the anal lifting movement for the first time, and generates a resistance value for a subsequent resistance training process including the anal lifting movement based on the dynamic pressure value of the pubovaginal muscle or puborectalis muscle.

[0040] According to a preferred embodiment, when the myoelectric signal parameter related to the fast muscle contracted under the stimulation of the electrical stimulation module provided by the myoelectric signal detection module is lower than α, the Kegel training module generates the resistance training process of the first mode. The resistance training process of the first mode includes vaginal contraction exercise and vaginal contraction resistance exercise.

[0041] According to a preferred embodiment, when the electromyographic signal parameters provided by the electromyographic signal detection module and related to the fast muscles that undergo muscle contraction under the stimulation of the electrical stimulation module are within the range of α to β, the Kegel training module generates the resistance training process of the second mode.

[0042] According to a preferred embodiment, when the myoelectric signal parameter related to the fast muscle that undergoes muscle contraction under the stimulation of the electrical stimulation module provided by the myoelectric signal detection module is higher than β, the Kegel training module generates the resistance training process of the third mode. The resistance training process of the second mode includes vaginal contraction exercise and vaginal contraction resistance exercise, wherein the number of vaginal contractions in the resistance training process in the second mode is lower than the number of vaginal contractions in the resistance training process in the first mode, and the maximum vaginal contraction force holding time in the resistance training process in the second mode is higher than the maximum vaginal contraction force holding time in the resistance training process in the first mode. The resistance training process of the third mode includes vaginal contraction exercise and vaginal contraction resistance exercise, wherein the number of vaginal contractions in the resistance training process in the third mode is lower than the number of vaginal contractions in the resistance training process in the second mode, and the maximum vaginal contraction force holding time in the resistance training process in the third mode is higher than the maximum vaginal contraction force holding time in the resistance training process in the second mode.

[0043] According to a preferred embodiment, the resistance training process at least includes endurance training for exercising slow muscles of the pelvic floor muscles and strength training for exercising fast muscles of the pelvic floor muscles.

[0044] Preferably, the endurance training for exercising the slow muscles of the pelvic floor muscles means that: the number of vaginal contractions per unit time in the resistance training process of the first mode is lower than the number of vaginal contractions per unit time in the resistance training process of the second mode. The number of vaginal contractions per unit time in the resistance training process of the second mode is lower than the number of vaginal contractions per unit time in the resistance training process of the third mode. With the gradual increase in the muscle strength of the pelvic floor muscles, medical staff can gradually increase the intensity of the training.

[0045] Preferably, strength training for exercising the fast muscles of the pelvic floor refers to: a training method using the time to maintain the maximum contraction force of the vagina as an indicator. The time to maintain the maximum contraction force in the resistance training process of the first mode is shorter than the time to maintain the maximum contraction force in the resistance training process of the second mode. The time to maintain the maximum contraction force in the resistance training process of the second mode is shorter than the time to maintain the maximum contraction force in the resistance training process of the third mode. Preferably, the number of maximum contraction forces in different modes is fixed and less than the number of vaginal contractions in the first mode. For example, the number of vaginal contractions in the first mode is 200 times within 30 minutes, and the number of strength training used to exercise the fast muscles of the pelvic floor is less than 200 times.

[0046] Preferably, the resistance training process is the simultaneous completion of endurance training and strength training. For example, when the Kegel training module generates the resistance training process of the third mode, the Kegel training module can sense the contraction of the user's vagina based on the pressure sensitive element arranged on the surface of its airbag. The user can maintain the contraction action for a specified time after completing the contraction action. For example, the voice component reminds the user that the current exercise is endurance training and strength training, and the user can contract the vagina and maintain it for more than 2 seconds. The Kegel training module determines that the current exercise meets the requirements, prompts the user through the voice component to pass, and enters the next exercise preparation.

[0047] According to a preferred embodiment, a drug outlet is provided at the distal end of the first component, the drug outlet is communicated with a drug storage tube, and an exogenously supplied drug is obtained based on the communicated drug storage tube.

[0048] When the first component enters the vagina or rectum from the distal end, the drug outlet preferentially fills the rectum or vagina with lubricating drugs, and the first component enters the vagina or rectum in a rotating manner to evenly apply the lubricating drugs on the inner wall of the vagina or rectum and the surface of the first component.

[0049] According to a preferred embodiment, a plurality of electrodes are disposed on the inner surface of the airbag, wherein the electrodes include a first microelectrode and a second microelectrode, and the voltage between the first microelectrode and the second microelectrode is the discharge voltage of the electrodes.

[0050] The present invention provides a pelvic floor muscle training method, characterized in that it comprises the following steps:

[0051] Sending a signal to terminate the current to the electrical stimulation module when the frequency domain characteristics of the electromyographic signal parameters related to the pelvic floor muscles that contract under electrical stimulation change significantly;

[0052] In response to the electrical stimulation module stopping sending current, the prompting unit automatically prompts the user to perform anal lifting movements under the control of the nerve;

[0053] The Kegel training module generates a resistance training process including anal lifting movements based on the electromyographic signal parameters related to the user's fast muscles transmitted by the electromyographic signal detection module;

[0054] In response to the completion of the resistance training process, the control unit controls the electrical stimulation module to start working. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Figure 1 It is a simplified schematic diagram of module connection relationship of a preferred embodiment provided by the present invention;

[0056] Figure 2 It is a schematic diagram of the modular connection relationship provided by the present invention;

[0057] Figure 3 It is a schematic diagram of the electrode structure provided by the present invention.

[0058] Reference numerals list

[0059] 10: Kegel training module; 100: first component; 110: silicone body; 111: medicine outlet; 120: air bag; 130: medicine storage tube; 140: first pipeline; 150: air flow control component; 20: electrical stimulation module; 30: electromyographic signal detection module; 40: pressure sensitive element; 50: electrode; 51: first microelectrode; 52: second microelectrode; 60: control unit; 70: prompt unit. DETAILED DESCRIPTION

[0060] The following is a detailed description with reference to the accompanying drawings.

[0061] In this application, "proximal end" refers to the end close to the operator, and "distal end" refers to the end far from the operator.

[0062] Example 1

[0063] The present invention provides a pelvic floor muscle group training system, comprising: an electromyographic signal detection module 30, which detects the dynamically changing electromyographic signal parameters of the pelvic floor muscle group located at the perineum and the rectus abdominis located at the abdomen of the user, respectively, to obtain the dynamically changing electromyographic signal parameters of the pelvic floor muscle group and the rectus abdominis of the user; an electrical stimulation module 20, which comprises an electrode 50 arranged at the anus or vagina of the user, and the electrode 50 provides an electric current transmitted to the muscles of the anus or vagina of the user; the system further comprises a Kegel training module 10, which responds to the detection of the user's anal lifting action by the electromyographic signal detection module 30 to provide a resistance that dynamically changes based on the electromyographic signal parameters of the pelvic floor muscle group of the user for the contraction of the pubovaginal muscle or the puborectalis muscle of the user when performing the anal lifting action, and a control unit 60 is configured to cross-control the activation of the EMS energy transmitted by the electrical stimulation module 20 and the transmission of the resistance provided by the Kegel training module 10, such as Figure 2 shown.

[0064] According to a preferred embodiment, the cross control refers to:

[0065] Based on the electromyographic signal parameters related to the pelvic floor muscle group that undergoes muscle contraction under the stimulation of the electrical stimulation module 20 provided by the electromyographic signal detection module 30, the control unit 60 can send a signal to the electrical stimulation module 20 to terminate the current when the frequency domain characteristics of the electromyographic signal parameters change significantly; in response to the electrical stimulation module 20 terminating the sending of current, the prompt unit 70 automatically prompts the user to perform the anus lifting movement under nerve control; the Kegel training module 10 generates a resistance training process including the anus lifting movement based on the electromyographic signal parameters related to the fast muscles of the user transmitted by the electromyographic signal detection module 30; in response to the completion of the resistance training process, the control unit 60 controls the electrical stimulation module 20 to start working.

[0066] The normal vaginal diameter of an adult female is 2 to 4 cm. When the user starts using it, first put the first component 100 of the Kegel training module 10 into the vagina. Generally, when the airbag 120 of the first component 100 is not opened, the diameter of the first component 100 can be set to 2 cm. When the surface of the first component 100 does not feel attached to the inner wall of the vagina and the first component 100 is stagnant in the vagina for more than 2 seconds based on the operation of the medical staff, the airbag 120 of the first component 100 can automatically expand based on the airflow transmitted by the external airflow control component 150 until the airbag 120 contacts the inner wall of the vagina.

[0067] At this time, the first component 100 is engaged with the vagina, but does not exert pressure on the vagina. Such a setting can prevent the first component 100 from slipping out of the vagina during exercise and interrupting the exercise, and also prevent the user from being unable to contract the vagina due to excessive pressure on the vagina, which results in the user being unable to exercise.

[0068] When the first component 100 is stabilized in the vagina, the medical staff can manually turn on the electrical stimulation module 20. With the turning on of the electrical stimulation module 20, the electromyographic signal detection module 30 also starts to detect the electromyographic signal parameters of the user's pelvic floor muscle group.

[0069] When the MDF trend of the electromyographic signal parameters of the user's pelvic floor muscles presents a positive value, and the RMS trend presents a negative value, the control unit 60 controls the electrical stimulation module 20 to stop working.

[0070] Preferably, the following R is the RMS value of the signal x(t), which is expressed in the time interval 0 to T as follows:

[0071]

[0072] The prompting unit 70 has a voice component and a display screen.

[0073] The display begins to show a schematic diagram of the principle of pelvic floor muscle group force, and at the same time, the voice component prompts the user to voluntarily contract the vagina based on the feeling in the electrical stimulation area.

[0074] The electromyographic signal detection module 30 starts detecting the electromyographic signal parameters of the pelvic floor muscle group and the electromyographic signal parameters of the rectus abdominis muscle.

[0075] Based on the fact that the electrical stimulation module 20 stops sending current and the electromyographic signal detection module 30 detects that the patient's pubovaginal muscle or puborectalis muscle begins to contract, the Kegel training module 10 obtains the dynamic pressure value of the pubovaginal muscle or puborectalis muscle based on the pressure sensitive element 40 set on the outer surface of its airbag 120 when the user performs the anal lifting movement for the first time, and generates a resistance value for the subsequent resistance training process including the anal lifting movement based on the dynamic pressure value of the pubovaginal muscle or puborectalis muscle.

[0076] Before the user completes the first vaginal contraction, the airbag 120 will not expand or shrink. When the user's vaginal contraction lasts for more than 2 seconds, the control unit 60 receives the stable pressure data transmitted by the Kegel training module 10 and generates a first pressure value. Based on the state classification of the user's pelvic floor muscle group, the Kegel training module 10 generates a second pressure value formed by the airbag 120 and the inner wall of the vagina in a relaxed state. The airbag 120 expands until the pressure value between its surface and the inner wall of the vagina reaches the second pressure value.

[0077] Preferably, based on the muscle strength measurement, the muscle strength of the user's pelvic floor muscle group is divided into levels 0 to V. When the user's pelvic floor muscle group contracts for 0 seconds, its muscle strength is level 0; when it lasts for 1 second, the muscle strength is level I; and so on, when it lasts for 5 seconds, the muscle strength is level V.

[0078] When the patient's muscle strength is level V, the second pressure value is 4 / 5 of the first pressure value. When the patient's muscle strength is level IV, the second pressure value is 3 / 5 of the first pressure value. When the patient's muscle strength is level III, the second pressure value is 2 / 5 of the first pressure value. When the patient's muscle strength is level II, the second pressure value is 1 / 5 of the first pressure value. When the patient's muscle strength is level I, the airbag 120 remains unchanged.

[0079] When the myoelectric signal parameter related to the fast muscle that undergoes muscle contraction under the stimulation of the electrical stimulation module 20 provided by the myoelectric signal detection module 30 is lower than α, the Kegel training module 10 generates the resistance training process of the first mode. When the myoelectric signal parameter related to the fast muscle that undergoes muscle contraction under the stimulation of the electrical stimulation module 20 provided by the myoelectric signal detection module 30 is within the range of α to β, the Kegel training module 10 generates the resistance training process of the second mode. When the myoelectric signal parameter related to the fast muscle that undergoes muscle contraction under the stimulation of the electrical stimulation module 20 provided by the myoelectric signal detection module 30 is higher than β, the Kegel training module 10 generates the resistance training process of the third mode. Preferably, α is 35μV. β is 45μV.

[0080] Based on the reduction of the user's rapid contraction ability, the medical staff can determine the resistance training process of the first mode through external input. The resistance training process of the first mode can refer to the number of vaginal contractions per unit time.

[0081] The number of vaginal contractions per unit time in the resistance training process of the first mode is lower than the number of vaginal contractions per unit time in the resistance training process of the second mode. The number of vaginal contractions per unit time in the resistance training process of the second mode is lower than the number of vaginal contractions per unit time in the resistance training process of the third mode. With the gradual increase in the muscle strength of the pelvic floor muscles, medical staff can gradually increase the intensity of exercise. For example, in the first mode, the resistance training process refers to completing 200 vaginal contractions within 30 minutes; in the second mode, the resistance training process refers to completing 200 vaginal contractions within 25 minutes; in the third mode, the resistance training process refers to completing 200 vaginal contractions within 20 minutes.

[0082] According to a preferred embodiment, within a single exercise cycle, muscle strength will decrease as the number of passive and active exercises increases. Therefore, with one passive exercise and one active exercise alternating as one cycle, after the first cycle is completed, the parameter standard for judging the electromyographic signal parameters of fast muscles can be reduced, that is, the parameter standard α used to judge the electromyographic signal parameters of fast muscles in the first cycle is greater than the parameter standard α used to judge the electromyographic signal parameters of fast muscles in the second cycle. When a cycle is completed, the system can automatically update the parameter standard α. Preferably, the variable of α in each cycle can be confirmed based on the judgment of medical staff. For example, α in the first cycle is 35μV, α in the second cycle is 33μV, and α in the third cycle is 31μV.

[0083] Preferably, when the autonomous exercise mode is completed, the medical staff can manually switch back to the electrical stimulation mode.

[0084] Preferably, based on the setting, after the autonomous exercise mode is completed, the control unit 60 can automatically switch back to the electrical stimulation mode by the number of intervals of electromyographic signal parameters that meet the requirements.

[0085] Based on the above settings, the system can inhibit bladder activity, intestinal activity, spasm under electrical stimulation, and activate the pelvic floor muscles. The system is suitable for diseases such as urinary incontinence and vaginal collapse caused by bladder sphincter dyssynergia, neuroprotective reflexes or voluntary contractions. The system is also suitable for evaluating the muscle strength status of elderly people with urinary incontinence and fecal incontinence.

[0086] The prompt unit 70 can also include a vibration component. Since the user will be distracted when stimulated and cannot obtain prompt information in time through vision and hearing, the vibration component can enter the rectum or vagina of the human body at the same time as the first component 100, and vibrate in the rectum or vagina of the patient when it is necessary to prompt the patient, prompting the patient to change the exercise mode.

[0087] Example 2

[0088] This embodiment provides a Kegel training module 10 for insertion into the vagina or rectum.

[0089] The Kegel training module 10 at least comprises a first component 100 disposed in the vagina or rectum of the user and an airflow control component 150 connected to the first component 100 and capable of providing air to the first component 100 and controlled by the control unit 60, wherein the first component 100 comprises an airbag 120 and a pressure sensitive element 40 mounted on the outer surface of the airbag 120, such as Figure 1 As shown. The first component 100 is provided with a silicone body 110. The diameter of the silicone body 110 is less than 1 cm. The airbag 120 is wrapped on the outside of the silicone body 110. A drug storage tube 130 is provided inside the silicone body 110 for transmitting the preparation flowing out of the drug outlet 111 at the distal end of the first component 100. The silicone body 110 also includes a first pipeline 140 for transmitting gas to the airbag 120. The distal end of the first pipeline 140 is connected to the airbag 120. The proximal end of the first pipeline 140 is connected to the airflow control component 150. The silicone body 110 is made of a flexible material, which can be targeted at a curved position in the vagina or rectum.

[0090] According to a preferred embodiment, the first component 100 can be a wearable component. The first component 100 is provided with an anti-slipping element. The anti-slipping element is arranged at the proximal end of the first component 100. Preferably, the anti-slipping element is a sheet-like body with a diameter greater than the diameter of the vaginal opening or the anus.

[0091] A drug outlet 111 is provided at the distal end of the first component 100, and the drug outlet 111 is connected to the drug storage tube 130, and obtains exogenously supplied drugs based on the connected drug storage tube 130. Preferably, the multiple electrodes 50 may include a three-pole arrangement. The three-pole arrangement may be an unbalanced three-pole arrangement, wherein the first pole of the plurality of electrodes 50 is greater than the second and third poles of the plurality of electrodes 50, and has opposite charges to the second and third electrodes 50 of the plurality of electrodes 50. Such an arrangement concentrates the stimulation signal on the pudendal nerve area. The angle between the second and third electrodes 50 may be 100° to 140°. Preferably, a plurality of electrodes 50 are provided on the inner surface of the airbag 120, wherein the electrodes 50 include a first microelectrode 51 and a second microelectrode 52, and the voltage between the first microelectrode 51 and the second microelectrode 52 is the discharge voltage of the electrode 50, such as Figure 3 shown.

[0092] According to a preferred embodiment, the airbag 120 needs to be disposed at a position close to the distal end of the silicone body 110 so that the silicone body 110 can reach a designated position requiring electrical stimulation when entering the vagina or rectum.

[0093] Preferably, the Kegel training module 10 further comprises a rubber sheet. The lubricating effect of the rubber sheet prevents the pain caused by external objects (such as the airbag proposed in the present invention) to the vagina due to vaginal dryness, thereby improving the comfort of the Kegel training module 10.

[0094] It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention specification and its drawings are illustrative and do not constitute a limitation of the claims. The scope of protection of the present invention is defined by the claims and their equivalents. The present invention specification contains multiple inventive concepts, such as "preferably", "according to a preferred embodiment" or "optionally", all of which indicate that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to file a divisional application based on each inventive concept. Throughout the text, the feature guided by "preferably" is only an optional method and should not be understood as a must-have setting. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.

Claims

1. A pelvic floor muscle training system, comprising: An electromyographic signal detection module (30) detects the electromyographic signals of the user's pelvic floor muscle group including the pubovaginal muscle or the puborectalis muscle and the rectus abdominis muscle, which are dynamically changed; An electrical stimulation module (20) comprising electrodes (50) disposed in the anus or vagina of the user to provide muscle electrical stimulation energy; It is characterized in that The system also includes a Kegel training module (10), When the myoelectric signal detected by the myoelectric signal detection module (30) reflects that the user is performing an anal lifting exercise, the Kegel training module (10) provides resistance to the contraction of the pubovaginal muscle or the puborectalis muscle of the user performing the anal lifting exercise, and the resistance can change dynamically based on the myoelectric signal parameters of the pubovaginal muscle or the puborectalis muscle of the user. The system further comprises a control unit (60), wherein the control unit (60) is configured to cross-control a switch of the muscle electrical stimulation energy delivered by the electrical stimulation module (20) and a switch of the resistance delivered by the Kegel training module (10), wherein the cross-control refers to: Based on the myoelectric signal parameters related to the pubovaginal muscle or the puborectalis muscle provided by the myoelectric signal detection module (30), the control unit (60) can send a signal to terminate the current to the electrical stimulation module (20) when the frequency domain characteristics of the myoelectric signal parameters change, indicating that the pubovaginal muscle or the puborectalis muscle is in a fatigued state, wherein the pubovaginal muscle or the puborectalis muscle is in a state of receiving muscle electrical stimulation energy transmitted by the electrical stimulation module (20); In response to the electrical stimulation module (20) stopping sending current, the prompting unit (70) for prompting the user to change the movement state prompts the user to perform anal lifting movements under the control of the nerves; The Kegel training module (10) generates a resistance training process including anal lifting movements based on the electromyographic signal parameters related to the fast muscles of the pubovaginal muscles or puborectalis muscles of the user transmitted by the electromyographic signal detection module (30); In response to the completion of the resistance training process, the control unit (60) controls the electrical stimulation module (20) to start working.

2. The pelvic floor muscle training system according to claim 1, characterized in that: The Kegel training module (10) comprises at least a first component (100) arranged in the vagina or rectum of a user and an airflow control component (150) connected to the first component (100) and capable of supplying air to the first component (100) and controlled by the control unit (60), wherein the first component (100) comprises an air bag (120) and a pressure sensitive element (40) mounted on the outer surface of the air bag (120).

3. The pelvic floor muscle training system according to claim 2, characterized in that: Based on the electrical stimulation module (20) stopping sending current and the electromyographic signal detection module (30) detecting that the pubovaginal muscle or puborectalis muscle of the user begins to contract, the Kegel training module (10) obtains the dynamic pressure value of the pubovaginal muscle or puborectalis muscle based on the pressure sensitive element (40) arranged on the outer surface of its air bag (120) when the user performs the anal lifting movement for the first time, and generates a resistance value for a subsequent resistance training process including the anal lifting movement based on the dynamic pressure value of the pubovaginal muscle or puborectalis muscle.

4. The pelvic floor muscle training system according to claim 3, characterized in that: When the electromyographic signal parameter related to the fast muscle contracting under the stimulation of the electrical stimulation module (20) provided by the electromyographic signal detection module (30) is lower than α, the Kegel training module (10) generates the resistance training process of the first mode, wherein the resistance training process of the first mode includes vaginal contraction exercise and vaginal contraction resistance exercise.

5. The pelvic floor muscle training system according to claim 4, characterized in that: When the myoelectric signal parameters provided by the myoelectric signal detection module (30) and related to the fast muscles that undergo muscle contraction under the stimulation of the electrical stimulation module (20) are within the range of α to β, the Kegel training module (10) generates the resistance training process of the second mode, wherein the resistance training process of the second mode includes vaginal contraction exercises and vaginal contraction resistance exercises, wherein the number of vaginal contractions in the resistance training process in the second mode is lower than the number of vaginal contractions in the resistance training process in the first mode, and the maximum vaginal contraction force maintenance time in the resistance training process in the second mode is higher than the maximum vaginal contraction force maintenance time in the resistance training process in the first mode.

6. The pelvic floor muscle training system according to claim 5, characterized in that: When the myoelectric signal parameter related to the fast muscle that undergoes muscle contraction under the stimulation of the electrical stimulation module (20) provided by the myoelectric signal detection module (30) is higher than β, the Kegel training module (10) generates the resistance training process of the third mode, and the resistance training process of the third mode includes vaginal contraction exercises and vaginal contraction resistance exercises, wherein the number of vaginal contractions in the resistance training process in the third mode is lower than the number of vaginal contractions in the resistance training process in the second mode, and the maximum vaginal contraction force maintenance time in the resistance training process in the third mode is higher than the maximum vaginal contraction force maintenance time in the resistance training process in the second mode.

7. The pelvic floor muscle training system according to claim 6, characterized in that: The distal end of the first component (100) is provided with a drug outlet (111), the drug outlet (111) is connected to the drug storage tube (130), and obtains exogenously supplied drugs based on the connected drug storage tube (130).

8. The pelvic floor muscle training system according to claim 7, characterized in that: A plurality of electrodes (50) are arranged on the inner surface of the airbag (120), wherein the electrodes (50) include a first microelectrode (51) and a second microelectrode (52), and the voltage between the first microelectrode (51) and the second microelectrode (52) is the discharge voltage of the electrode (50).

9. The pelvic floor muscle training system according to claim 8, characterized in that: The electromyographic signal detection module (30) can generate electromyographic signal parameters for judging the user's pelvic floor muscle group based on each contraction of the user's pelvic floor muscle group, the control unit (60) updates the resistance parameters for resisting the contraction of the user's pelvic floor muscle group based on the electromyographic signal parameters of each maximum vaginal contraction force, and the Kegel training module (10) generates the amount of gas to be filled into its air bag based on the resistance parameters.

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