Modular device for pelvic floor muscle status assessment and method of use thereof

Abstract

The application discloses a modular device for pelvic floor muscle state evaluation and a use method thereof, and the device comprises a probe main body, an electrode ring and an airbag ring; the probe main body is divided into a head part, a main body part, a base part and a handheld part from top to bottom, the surface of the main body part is provided with a longitudinal groove from top to bottom, which is used for connecting corresponding protrusions on the airbag ring or the electrode ring, the main body part is distributed with a plurality of layers of port layers from top to bottom, each layer of port layers comprises a plurality of pairs of ports, and each pair of ports comprises an electrode interface and an air hole interface; the outer periphery of each layer of port layers is provided with a detachable electrode ring or airbag ring, the inside of the base part is provided with a circuit system for processing electromyographic information and pressure information, the outer side of the electrode ring is uniformly distributed with electrode pieces, the outer side of the airbag ring is uniformly distributed with airbags, and the inside of the ring corresponding to the center point of each airbag is provided with a gas charging and discharging port. The electrode ring or the airbag ring can be assembled on the main body part at will, different scene use requirements can be met, and the device is convenient to use.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a modular device for pelvic floor muscle state assessment and a method of using the same. BACKGROUND

[0002] Pelvic floor dysfunction (PFD) is one of the common diseases in women, which not only seriously affects the quality of life of patients, but also increases the social and economic burden. PFD refers to the change of position and function of pelvic organs caused by abnormality of pelvic floor muscles and fascial tissue, which is manifested as pelvic organ prolapse, urinary incontinence, sexual dysfunction, intestinal motility disorder, chronic pelvic pain, etc. The risk factors include pregnancy and childbirth, obesity, menopausal status, chronic constipation and cough, connective tissue abnormal disease, etc. At present, pregnancy and childbirth are the main risk factors of PFD. About 25% to 50% of women have mild pelvic organ prolapse after vaginal delivery, 50% of women have urinary incontinence, and 17% of women have fecal incontinence.

[0003] At present, the diagnosis and treatment of pelvic floor dysfunction are usually realized by the combination of a host and a vaginal probe. The electrodes of the vaginal probe placed in the vagina collect the electrical signals of the pelvic floor muscle movement, and the pressure balloon of the vaginal probe collects the changes of the intravaginal pressure, which are transmitted to the host. The host analyzes the incoming signals, evaluates the function of the pelvic floor muscles of the patient, and assists in the diagnosis of diseases. The host formulates special electrical stimulation, airbag stretching training or biofeedback training according to the operation of the doctor, and treats the pelvic floor muscles through the electrodes or airbags of the vaginal probe. For the case of muscle hypertonia, the pressure airbag is usually used for stretching training, and for the case of muscle relaxation, electrical stimulation and biofeedback training are usually used.

[0004] At present, most vaginal probes only have the structure of electrode sheets or airbags, and cannot use airbags and electrical stimulation to treat diseases at the same time. Although some excellent inventions place electrodes at the near and far ends of the probe, with a pressure airbag in the middle. However, this combination is a fixed device, which is not diversified and cannot be applied to patients with complex pelvic floor dysfunction diseases and patients after surgery on the external genitalia, such as women who have undergone lateral incision during vaginal delivery. Eventually, the part close to the vaginal orifice will be scarred and contracted due to hypertonia, and the part far from the vaginal orifice will be stretched excessively during delivery, resulting in muscle relaxation. The current treatment method is to treat the hypertonia area by electrical stimulation first and then by airbag. However, due to the electrical conductivity of the tissue, electrical stimulation can also cause the hypertonia area to contract strongly, which can aggravate the injury. SUMMARY

[0005] Inventive purpose: In view of the defect that the air bag and the electrode sheet cannot be used simultaneously in the prior art, the application discloses a modular device for pelvic floor muscle state evaluation and a use method thereof, and electrode rings or air bag rings are assembled on the main body part to meet the use requirements of different scenes and facilitate use.

[0006] Technical scheme: In order to achieve the above inventive purpose, the application adopts the following technical scheme.

[0007] A modular device for pelvic floor muscle state evaluation, comprising a probe main body, an electrode ring and an air bag ring.

[0008] The probe main body is a hollow structure and is divided into a head part, a main body part, a base part and a handheld part from top to bottom, and the probe main body as a whole is made of hard material; the head part is hemispherical at the top end and is connected with the main body part in a rotary dismounting mode; the main body part is a long cylindrical body, the surface of the main body part is provided with a longitudinal groove from top to bottom, which is used for connecting the corresponding protrusions on the air bag ring or the electrode ring; the main body part is distributed with a plurality of layers of port layers from top to bottom, each layer of port layers comprises a plurality of pairs of ports, and each pair of ports comprises an electrode interface and a gas hole interface; each layer of port layers is provided with a detachable electrode ring or air bag ring on the outer periphery; the base part is similar to an umbrella structure, and the inside of the base part is a circuit system for processing muscle electric information and pressure information; and the handheld part is a cylindrical body and is provided with threads on the surface.

[0009] The electrode ring is a hollow ring-shaped hard structure, the electrode ring is uniformly distributed with electrode sheets on the outer side, each electrode sheet is provided with an electrode port at the position corresponding to the center point of the inner side of the ring, the electrode port is used for connecting the electrode interface on the surface of the probe main body, and the inner side of the electrode ring is further provided with a protrusion, which is used for connecting the groove on the surface of the main body part to fix the electrode ring and the probe main body.

[0010] The air bag ring is a hollow ring-shaped hard structure, the air bag ring is uniformly distributed with air bags on the outer side, each air bag is provided with a gas charging and discharging port at the position corresponding to the center point of the inner side of the ring, the gas charging and discharging port is used for connecting the gas hole interface of the probe main body, and the inner side of the air bag ring is further provided with a protrusion, which is used for connecting the groove on the surface of the main body part to fix the air bag ring and the probe main body.

[0011] Preferably, the electrode ring is distributed with at least four electrode sheets on the outer side, the center points of each electrode sheet are spaced apart by 90 degrees and are located at 0 o'clock, 3 o'clock, 6 o'clock and 9 o'clock positions respectively; and the air bag ring is distributed with at least four air bags on the outer side, the air bags are expanded after being inflated, the center points of each air bag are spaced apart by 90 degrees and are located at 0 o'clock, 3 o'clock, 6 o'clock and 9 o'clock positions respectively, and there is a certain distance between each air bag.

[0012] Preferably, the main body part is distributed with six layers of port layers from top to bottom, each layer comprises at least four pairs of ports, the pairs of ports are spaced apart by 90 degrees and are located at 0 o'clock, 3 o'clock, 6 o'clock and 9 o'clock positions respectively, and each pair of ports comprises an electrode interface and a gas hole interface.

[0013] Preferably, the circuit system comprises a master module, a signal acquisition module, a power supply module, a wireless communication module, a gas charging and discharging driving module, an electrical stimulation driving module, the signal acquisition module comprises a pressure sensor module, a flow sensor module, an electromyography sensor module, and an analog-to-digital conversion module; the signal acquisition module converts the electromyography signals collected by the electrodes and the pressure signals collected by the air bags into electrical signals and transmits them to the master module; the power supply module is used to provide the master module, the signal acquisition module, the electrical stimulation driving module, the gas charging and discharging driving module, and the wireless communication module with current of specific parameters; the wireless communication module is used to establish a connection between the master unit and the terminal; the master module transmits information analyzed and processed to the terminal; the terminal transmits instructions to the master module; the master module transmits the instructions to the electrical stimulation driving module and / or the gas charging and discharging driving module according to the received information; then the electrical stimulation driving module and / or the gas charging and discharging driving module controls the electrode pads on the electrode ring and / or the air bags on the air bag ring to execute the electrical stimulation and / or the gas charging and discharging instructions; the gas charging and discharging driving module comprises an air charging module, an air discharging and vacuuming module, and an air pump.

[0014] A method for using a modular device for pelvic floor muscle state assessment, applied to any of the above-described modular devices for pelvic floor muscle state assessment, comprising the following steps:

[0015] Step one, a electrode ring is sleeved on the main body part, and pelvic floor muscle electrical detection is performed by using the electrode ring to obtain pelvic floor muscle function parameters;

[0016] Step two, an air bag ring is sleeved on the main body part, and pelvic floor muscle pressure detection is performed by using the air bag ring to obtain pressure acquisition data;

[0017] Step three, in the circuit system frame of the base part, pelvic floor muscle function parameters and pressure acquisition data are used for evaluation and analysis to obtain pelvic floor muscle state assessment results.

[0018] Preferably, step one specifically comprises: a electrode ring is sleeved on the main body part, and pelvic floor muscle electrical detection is performed by using the electrode ring; the subject sequentially performs movements according to template instructions; the electromyography values changing over time are collected, and an electromyography graph is drawn to obtain pelvic floor muscle function parameters, which include pelvic floor muscle stability parameter A (unit: microvolt, μV), pelvic floor muscle fast muscle function parameter B (unit: second, s), pelvic floor muscle slow muscle function parameter C (unit: second, s), pelvic floor muscle post-movement stability parameter D (unit: microvolt, μV), and pelvic floor muscle post-movement baseline variability F.

[0019] Preferably, the subject sequentially performs movements according to template instructions, electromyography values changing over time are collected, and an electromyography graph is drawn to obtain pelvic floor muscle function parameters, and the specific process comprises:

[0020] (1) After attaching the electrode ring to the main body, the modular device is placed inside the subject's vagina. After the subject relaxes for 30 seconds according to the template instructions, the pelvic floor muscle stability parameter A at the corresponding position of each electrode is obtained: in, X1, X2, X3, X4, ..., X n To record all electromyographic values ​​for each electrode pad over 30 seconds;

[0021] (2) The subject followed the template instructions and immediately contracted and relaxed once after hearing the first instruction. After hearing the second instruction, the subject immediately contracted and relaxed once. This was repeated a total of 5 times.

[0022] Electromyography (EMG) atlases were plotted based on EMG values, and the time t was recorded for each command issued. s1 t s2 t s3 t s4 t s5 ;

[0023] The time corresponding to the peak values ​​of the five electromyography (EMG) signals is recorded as t. m1 t m2 t m3 t m4 t m5 ;

[0024] The initial electromyographic value of rapid contraction before the first peak after the command begins is X. 01 (Unit: seconds, s), X 01 Need to meet The condition, X 01 The corresponding time of occurrence is recorded as t1, and the rapid contraction initiation electromyographic value X before the second electromyographic value peak is recorded. 02 The corresponding time record for the occurrence is t2, and similarly, t3, t4, and t5 are obtained;

[0025] The electromyography (EMG) value of fast-twitch muscle recovery after the first EMG peak following the start of the command is X. 10 X 10 Need to meet The condition, X 10 The corresponding time of occurrence is recorded as t'1, and the electromyographic value X of fast-twitch muscle recovery after the second electromyographic peak is recorded. 20 The corresponding time is recorded as t2; similarly, t3, t4, and t5 are obtained; the pelvic floor muscle fast-twitch function parameters B for each electrode pad's corresponding position are obtained. Pelvic floor muscle fast-twitch function parameters B include fast-twitch mobilization time B1, fast-twitch contraction time B2, and fast-twitch relaxation time B3. Fast muscle contraction time Fast muscle relaxation time The fast muscle function parameter of the pelvic floor muscles is B = b1B1 + b2B2 + b3B3, where b1, b2, and b3 are weighting coefficients.

[0026] (3) Upon hearing the first instruction, the subject immediately performed a contraction and held it for 10 seconds. Then, upon receiving the instruction to stop contracting, the subject immediately relaxed for 10 seconds. The second instruction was followed by another contraction and held for 10 seconds. This was repeated a total of 5 times. Electromyographic values ​​(unit: microvolts, μV) were recorded for 8 seconds after each instruction, starting 1 second later, as X′1, X′2, X′3, X′4, ..., X′ n ;

[0027] Stability parameters during each slow-twitch muscle contraction hold: This was used to obtain the stability parameters C′1, C′2, C′3, C′4, and C′5 during the maintenance of slow muscle contractions in the 1st, 2nd, 3rd, 4th, and 5th contractions.

[0028] Record the electromyographic value X′ that recovers after the first command to stop contraction is issued. 10 Time, X′ 10 Need to meet The condition, X′ 10 The corresponding time of occurrence is recorded as T'1, and similarly, T′2, T′3, T′4, and T′5 are recorded.

[0029] Acquire the pelvic floor muscle slow-twitch muscle function parameters C at the corresponding location of each electrode, including stability parameters during the maintenance of slow-twitch muscle contraction. Slow muscle relaxation time The pelvic floor muscle slow-twitch function parameter C = c1C1 + C2C2, where c1 and c2 are weighting coefficients;

[0030] (4) Subjects relaxed for 30 seconds according to the template instructions, and all electromyographic values ​​within 30 seconds were recorded as X1, X2, X3, X4, X5...X n ; Obtain pelvic floor muscle stability parameters at the corresponding positions of each electrode after exercise. Baseline variability after pelvic floor muscle exercises in

[0031] Preferably, step two specifically includes: removing the electrode ring from the main body, fitting an airbag ring, and then using the airbag ring to detect pelvic floor pressure. The subject moves sequentially according to the template instructions to acquire pressure data. The pressure data includes the fast pelvic floor muscle strength parameter G, the slow pelvic floor muscle strength parameter H, the vaginal diameter, and the vaginal tissue elasticity coefficient E. The specific process includes:

[0032] (1) main body part outer electrode ring, set after the balloon ring, the modular device all the balloon vacuum placed in the vagina of the subject, the subject according to the template instructions relax, then 1 ml / s to the balloon ring of the balloon fill gas, stop inflation when reaching 20 mmHg, record when reaching 20 mmHg, each balloon inflation (unit: milliliter, ml), from top to bottom 0 point, 3 point, 6 point, 9 point position of the balloon inflation volume is V 10 , V 13 , V 16 , V 19 , V 20 , V 23 , V 26 , V 29 , V 30 , V 33 , V 36 , V 39 , V 40 , V 43 , V 46 , V 49 , V 50 , V 53 , V 56 , V 59 , V 60 , V 63 , V 66 , V 69 ;

[0033] According to the inflation volume of each balloon, the ring width is calculated according to the formula of the volume of a circular ring, and is recorded as R 10 , R 13 , R 16 , R 19 ... R 69 ;

[0034] The first ring of the balloon ring corresponds to the transverse diameter of the vagina X1=d+R 13 +R 19 ; the longitudinal diameter of the vagina Y1=d+R 10 +R 16 , wherein d is the diameter of the cross section of the probe main body; similarly, the transverse diameter of the vagina X2, X3, X4, X5, X6 corresponding to the second, third, fourth, fifth, sixth balloon ring, and the longitudinal diameter of the vagina Y2, Y3, Y4, Y5, Y6 are obtained;

[0035] According to the ring width record and the pressure 20 mmHg, the elasticity coefficient E (unit: mmHg / mm) of the vaginal tissue corresponding to each balloon position is calculated, and E 10 , E 13 , E 16 , E 19 ... E 69;

[0036] (2) The subject performs 5 times of fast contraction and fast relaxation of the pelvic floor muscles according to the template instructions, and records the data (unit: mmHg) of each pressure peak as P1, P2, P3, P4, P5 according to the time-pressure curve;

[0037] Obtain the fast muscle strength parameters of the pelvic floor muscles at the positions corresponding to each air bag

[0038] (3) The subject performs 1 time of contraction immediately after hearing the 1st instruction, maintains for 10 s, and then relaxes for 10 s immediately after the instruction to stop contraction, performs 1 time of contraction immediately after the 2nd instruction, maintains for 10 s, and repeats a total of 5 times; record all the pressure values for 8 s after 1 s of the start of each instruction as P'1, P'2, P'3, P'4,..., P' n ; stability parameters during each slow muscle contraction maintenance Obtain the stability parameters H1, H2, H3, H4, H5 during the 1st, 2nd, 3rd, 4th, and 5th slow muscle contraction maintenance, and obtain the slow muscle strength parameters of the pelvic floor muscles at the positions corresponding to each air bag

[0039] Preferably, the step three specifically comprises: in the circuit system framework of the base, evaluating and analyzing the pelvic floor muscle function parameters and the pressure collection data to obtain the pelvic floor muscle state evaluation results, including the comprehensive score of the pelvic floor muscles at each position, the pelvic floor muscle movement coordination evaluation, the pelvic floor muscle movement symmetry evaluation, the longitudinal diameter of the vagina, the transverse diameter of the vagina, the comprehensive score M of the pelvic floor muscles at each position is obtained by comprehensively calculating the pelvic floor muscle stability parameter A, the pelvic floor muscle fast muscle function parameter B, the pelvic floor muscle slow muscle function parameter C, the pelvic floor muscle movement post-stability parameter D, the vaginal tissue elasticity coefficient E, the pelvic floor muscle movement post-baseline variability F, the pelvic floor muscle fast muscle strength parameter G, and the pelvic floor muscle slow muscle strength parameter H; the comprehensive score M of the pelvic floor muscles = k1A + k2(BxG) + k3(CxH) + k4D + k5F + k6E + k7age, wherein age is the age of the subject, k1, k2, k3, k4, k5, and k6 are weighting coefficients, which are obtained by establishing a model analysis through previous clinical trial data results, the pelvic floor muscle movement symmetry evaluation method is to evaluate the symmetry of the pelvic floor muscle movement according to the comprehensive score M of the pelvic floor muscles at positions 3 and 9, and the pelvic floor muscle movement coordination evaluation method is to judge the continuity of the pelvic floor muscle movement of the subject according to the fast muscle mobilization time B1, the fast muscle contraction time B2, and the fast muscle relaxation time B3 obtained by the electromyographic detection of the pelvic floor muscles at each position, so as to judge whether the force exertion mode is correct.

[0040] Preferably, the use method further comprises: selecting and assembling the modular device according to the pelvic floor muscle state evaluation result, different port layers are respectively sleeved with electrode rings and air bag rings, air bag protection of the surgical scar site is realized, supplemental electrical stimulation of the movement delay site is realized, and air bag inhibition of the movement early site is realized.

[0041] Beneficial effects:

[0042] 1. The modular device of the present application can assemble electrode rings or air bag rings on the main body part as needed, which is convenient to use.

[0043] 2. The present application combines electromyographic detection and pressure detection, uses electromyographic detection to evaluate the reaction speed of the muscle and the stability of the muscle, uses pressure detection to evaluate the muscle strength, simultaneously uses pressure detection to evaluate the elasticity and inner diameter of the vagina, comprehensively scores the pelvic floor muscle according to the pressure detection result and the electromyographic detection result, and evaluates the symmetry and coordination of the pelvic floor muscle movement, which has more clinical value in assisting doctors in diagnosis and can be used as a reference before surgery.

[0044] 3. The use method of the present application is based on the device of the present application, adopts sequential electrical stimulation, supplemental electrical stimulation and air bag inhibition, can train the coordination and symmetry of the correct pelvic floor muscle force, and meets the use needs of doctors. BRIEF DESCRIPTION OF DRAWINGS

[0045] Figure 1 It is a structural schematic diagram of the modular device of the present application;

[0046] Figure 2 It is a structural schematic diagram of the modular device of the present application which assembles electrode rings and air bag rings;

[0047] Figure 3 It is a structural schematic diagram of the electrode ring of the present application;

[0048] Figure 4 It is a structural schematic diagram of the air bag ring of the present application;

[0049] Figure 5 It is a schematic diagram of the circuit system of the present application;

[0050] Figure 6 It is a flow chart of the use method of the present application;

[0051] Figure 7 It is a schematic diagram of the pelvic floor muscle evaluation result of the present application;

[0052] Figure 8 It is a structural schematic diagram of the modular device which assembles electrode rings and air bag rings at the same time. DETAILED DESCRIPTION

[0053] The following description, in conjunction with the accompanying drawings and embodiments, further explains and illustrates a modular device for assessing the condition of pelvic floor muscles and its usage method according to the present invention.

[0054] As attached Figure 1 and attached Figure 2 As shown, a modular device for assessing the condition of pelvic floor muscles includes a probe body 1, an electrode ring 2, and an airbag ring 3.

[0055] The probe body 1 has a hollow structure and is divided into a head 11, a main body 12, a base 13 and a handheld part 14 from top to bottom. The probe body 1 is made of a rigid material, such as plastic.

[0056] The top of the head 11 is hemispherical and is connected to the main body 12 by rotation. It is removed by rotation before the airbag ring 3 or electrode ring 2 is installed. After the airbag ring 3 or electrode ring 2 is installed, the top of the head (11) is rotated and fixed.

[0057] The main body 12 is a long cylindrical shape. A vertical groove 121 runs from top to bottom on the surface of the main body 12, used to connect the corresponding protrusion 4 on the airbag ring 3 or electrode ring 2, for fixing the electrode ring 2 or airbag ring 3 and preventing loosening that could cause unstable data transmission or ring detachment. The main body 12 has several port layers distributed from top to bottom. Each port layer includes several pairs of ports, and each pair of ports includes one electrode interface and one air vent interface. A detachable electrode ring 2 or airbag ring 3 is fitted around the outer periphery of each port layer. The modular device of this invention can fully address various clinical scenarios. Specific modular electrode rings and airbag rings can be selected and assembled into new vaginal probes according to the different muscle dysfunction problems in different locations, allowing for diversified use. For example, an airbag ring can be used in high-tension areas, and an electrical stimulation ring module can be used in relaxed areas. During use, the airbag expands the high-tension area to inhibit contraction and avoid secondary damage.

[0058] The handle 14 is cylindrical with threads on its surface to increase the friction between the operator's hand and the probe handle, making insertion into the vagina smoother and preventing slippage.

[0059] like Figure 3 As shown, the electrode ring 2 is a hollow, ring-shaped rigid structure. At least four electrode plates are distributed on the outer side of the electrode ring 2, with the center points of each electrode plate spaced 90° apart, located at the 0, 3, 6, and 9 o'clock positions respectively. There is a certain distance between each electrode plate. An electrode port is located on the inner side of the ring corresponding to the center point of each electrode plate, used to connect to the electrode interface on the surface of the probe body 1. The inner side of the electrode ring 2 also has a protrusion 4 for connecting to the groove 121 on the surface of the main body 12, fixing the electrode ring 2 and the probe body 1.

[0060] like Figure 4As shown, the airbag ring 3 is a hollow annular hard structure, and at least four airbags are distributed on the outer side. After inflation, it can be expanded, and the center points of each airbag are spaced 90° apart, respectively located at 0 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions. There is a certain distance between each airbag. The inboard position corresponding to the center point of each airbag has a gas charging and discharging port for connecting the gas hole interface on the surface of the probe body 1. The inboard also has a protrusion 4 for connecting the groove 121 on the surface of the main body part 12, fixing the airbag ring 3 and the probe body 1.

[0061] The main body part 12 has several layers of ports from top to bottom, including 6 layers of ports in some embodiments of the present application, each layer including at least 4 pairs of ports, each pair of ports spaced 90° apart, and the 4 pairs of ports located at 0 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions, respectively. Each pair of ports contains an electrode interface and a gas hole interface.

[0062] In the method of use of the present application, in step one, the electrode interfaces on the surface of the main body part 12 are connected to the electrode ports on the electrode ring, and each electrode piece on the electrode ring collects the pelvic floor muscle electromyography information of the corresponding contact part. In step three, according to the pelvic floor muscle electromyography information collected by the electrode pieces at different positions, the functions of different pelvic floor muscle groups are accurately evaluated. During use, according to the occurrence area of pelvic floor dysfunction, the electrode pieces can output different intensity parameters of electrical stimulation to different positions of the pelvic floor muscle. In some embodiments of the present application, for example, the muscle contraction ability of the 3 o'clock position of the 4th layer electrode ring from top to bottom is very poor, and the muscle contraction function of the 9 o'clock position is slightly poor. Therefore, the electrical stimulation output by the 3 o'clock position of the 4th layer electrode ring is stronger, and the electrical stimulation output by the 9 o'clock position of the 4th layer electrode ring is weaker. The present application can also avoid causing electrical stimulation damage to non-intended electrical stimulation area tissues, for example, the muscle contraction ability of the 3 o'clock position of the 2nd layer electrode ring from top to bottom is very poor, but the muscle contraction function of other parts is good. Therefore, only the 3 o'clock position of the 2nd layer electrode ring outputs electrical stimulation.

[0063] The air hole interface of the surface of the main body part 12 is connected with the inflation and deflation port on the air bag ring. In the second step, each air bag on the air bag ring collects the pelvic floor muscle pressure information of the corresponding part, and the muscle strength information of different pelvic floor muscle groups is accurately obtained. According to the system preset pressure value, each air bag is inflated to the initial pressure of all air bags, which can ensure the consistent contact of the air bag and the pelvic floor muscle, and ensure that the muscle fiber is at the optimal initial length, which is beneficial to muscle strength, and reduce the false positive results caused by poor muscle strength due to non-contact or deviation of the initial length of the muscle fiber. In the third step, the pressure signals of the pelvic floor muscles at different depths and different directions are accurately detected, so that the muscle function at different positions is accurately judged. In the use stage, according to the occurrence area of the pelvic floor muscle dysfunction, the air bag corresponding to the dysfunction area is inflated and deflated, and the pelvic floor muscle at the specific part is stretched, for example, the muscle high tension dysfunction of the 2nd layer 3 point position and the muscle high tension dysfunction of the 3rd layer 9 point position. The air bags at the 2nd layer 3 point position and the 3rd layer 9 point position are inflated and deflated respectively for treatment, which can also avoid the occurrence of muscle fiber tearing caused by excessive stretching of the normal part due to the inflation of the whole air bag.

[0064] As shown in Figure 5 The base part 13 is a similar umbrella structure, and the inside thereof is a circuit system composed of a main control module, a signal acquisition module, a power supply module, a wireless communication module, an inflation and deflation driving module, and an electrical stimulation driving module. The signal acquisition module includes a pressure sensor module, a flow sensor module, an electromyography sensor module, and an analog-to-digital conversion module; the pressure sensor is used to measure the pressure, the electromyography sensor is used to record the electromyography value, and the analog-to-digital conversion module is used to convert the electromyography signal collected by the electrode and the pressure signal collected by the air bag into an electrical signal and transmit it to the main control module. The power supply module is used to provide a current with specific parameters for the main control module, the signal acquisition module, the electrical stimulation driving module, the inflation and deflation driving module, and the wireless communication module. The wireless communication module is used to establish a connection between the main control unit and the terminal such as a mobile phone or a host computer. The main control module transmits the information analyzed and processed to the terminal, and the terminal transmits the instruction to the main control module. The inflation and deflation driving module includes an inflation module, a deflation and vacuum pumping module, and an air pump. The air pump is connected with the inflation module and the deflation and vacuum pumping module, respectively. The inflation module and the deflation and vacuum pumping module are in communication with the air hole interface on the air bag. The flow sensor module is connected with the inflation and deflation driving module, and is used to control the inflation and deflation rate of the air bag. The electrical stimulation driving module is connected with the electrode interface.

[0065] The signal acquisition module converts the myoelectric signals collected by the electrodes and the pressure signals collected by the air bags into electrical signals and transmits the electrical signals to the main control module. The main control module analyzes the electrical signals transmitted by the signal acquisition module, obtains the pelvic floor muscle state evaluation result, marks the pelvic floor muscle state scores of different parts in the preset vaginal structure diagram according to the distance from the vaginal orifice, and then transmits the information to a terminal with a display function through the wireless communication module. The terminal selects the corresponding assembly according to the score, and then transmits the instruction information to the main control module through the wireless communication module. The main control module transmits the instruction to the electrical stimulation driving module and / or the inflation and deflation driving module according to the received information, and then the electrical stimulation driving module and / or the inflation and deflation driving module control the electrode pieces on the electrode ring and / or the air bags on the air bag ring to execute the electrical stimulation and / or inflation and deflation instructions.

[0066] A method for using a modular device for pelvic floor muscle state evaluation is applied to any one of the above-described modular devices for pelvic floor muscle state evaluation, and includes the following steps:

[0067] Step one, an electrode ring is provided on the main body part, and the electrode ring is used for pelvic floor muscle electrical detection to obtain pelvic floor muscle function parameters;

[0068] Step two, an air bag ring is provided on the main body part, and the air bag ring is used for pelvic floor muscle pressure detection to obtain pressure collection data;

[0069] Step three, in the circuit system framework of the base part, the pelvic floor muscle function parameters and the pressure collection data are used for evaluation and analysis to obtain a pelvic floor muscle state evaluation result.

[0070] Step one specifically includes: an electrode ring is provided on the main body part, and the electrode ring is used for pelvic floor muscle electrical detection. The subject performs movements according to the template instructions in turn, the electromyogram is drawn by collecting the electromyogram values changing with time, and thus the pelvic floor muscle function parameters are obtained. The pelvic floor muscle function parameters include a pelvic floor muscle stability parameter A (unit: microvolt, μV), a pelvic floor muscle fast muscle function parameter B (unit: second, s), a pelvic floor muscle slow muscle function parameter C (unit: second, s), a pelvic floor muscle stability parameter D (unit: microvolt, μV) after movement, and a pelvic floor muscle baseline variability F after movement.

[0071] The specific method is as follows:

[0072] 1. After the electrode ring is provided on the main body part, the modular device is placed in the vagina of the subject. After the subject relaxes for 30 seconds according to the template instructions, the pelvic floor muscle stability parameter A (unit: microvolt, μV) of each electrode piece corresponding position is obtained. In an embodiment of the present application, 24 electrode pieces are provided, that is, the pelvic floor muscle stability parameters A of 24 electrode piece corresponding positions are obtained.

[0073] The method is as follows: For each electrode pad, record all electromyographic values ​​(unit: microvolts, μV) over 30 seconds as X1, X2, X3, X4, ..., X... n n is a preset parameter;

[0074] Pre-exercise resting baseline (unit: microvolt, μV) Pelvic floor muscle stability parameters (unit: microvolts, μV):

[0075] 2. Following the template instructions, the subject immediately performed a rapid contraction and relaxation once after hearing the first instruction, and again immediately after the second instruction, for a total of 5 repetitions, with each repetition consisting of one rapid contraction and relaxation. The fast-twitch muscle function parameters B (unit: seconds, s) of the pelvic floor muscles at the corresponding location of each electrode were obtained. These parameters include fast-twitch muscle activation time B1 (unit: seconds, s), fast-twitch muscle contraction time B2 (unit: seconds, s), and fast-twitch muscle relaxation time B3 (unit: seconds, s). The fast-twitch muscle activation time B1 represents the nerve's ability to control the muscle.

[0076] The specific process is as follows:

[0077] (1) Based on the electromyography values, draw an electromyography atlas and record the time (in seconds) of each command issued as t. s1 t s2 t s3 t s4 t s5 .

[0078] (2) Record the time (in seconds) corresponding to the peak values ​​of the 5 electromyography signals as t. m1 t m2 t m3 t m4 t m5 .

[0079] (3) The initial electromyographic value of the rapid contraction before the first electromyographic peak after the command begins is X. 01 (Units: microvolts, μV, X) 01 Need to meet The condition, X 01 The corresponding time of occurrence is recorded as t1 (unit: seconds, s). The electromyographic value X at the onset of rapid contraction before the second electromyographic peak. 02 The corresponding time of occurrence is recorded as t2 (unit: seconds, s). Similarly, t3, t4, and t5 are obtained.

[0080] (4) The electromyographic value of the fast-twitch muscle recovery muscle after the first electromyographic peak after the command begins is X. 10 (Unit: microvolt, μV), X 10 Need to meet The condition that X 10 The corresponding time of occurrence is recorded as t'1 (unit: seconds, s). The muscle recovery value X 20 The corresponding time of occurrence is recorded as t'2. Similarly, t'3, t'4, and t'5 are obtained.

[0081] (5) Fast muscle mobilization time (unit: seconds, s): Fast muscle contraction time (unit: seconds, s): Fast muscle relaxation time (unit: seconds, s):

[0082] (6) Pelvic floor muscle fast muscle function parameters (unit: seconds, s): B = b1B1 + b2B2 + b3B3, where b1, b2, and b3 are weighting coefficients, and the weighting coefficients are obtained through experiments;

[0083] 3. The subject follows the template instructions and performs a contraction immediately after hearing the first instruction for 10 seconds, then relaxes immediately after the stop contraction instruction for 10 seconds, performs a contraction immediately after the second instruction for 10 seconds, and repeats a total of 5 times. Obtain the pelvic floor muscle slow muscle function parameters C corresponding to the position of each electrode sheet, including the slow muscle contraction stability parameter C1 (unit: microvolts, μV) during the contraction, and the slow muscle relaxation time C2 (unit: seconds, s).

[0084] Method:

[0085] (1) Record all muscle electrical values (unit: microvolts, μV) for X'1, X'2, X'3, X'4,..., X'5 for 8 seconds after 1 second from the start of each instruction. n .

[0086] (2) Slow muscle contraction stability parameter (unit: microvolts, μV) during each contraction:

[0087] Thus, the slow muscle contraction stability parameters (unit: microvolts, μV) C'1, C'2, C'3, C'4, and C'5 during the first, second, third, fourth, and fifth contractions are obtained.

[0088] (3) Record the muscle recovery value X' 10 after the first stop contraction instruction (unit: seconds, s), X' 10 needs to meet the condition that X' 10 The corresponding time of occurrence is recorded as T'1 (unit:

[0089] seconds, s), and similarly, T'2, T'3, T'4, and T'5 (unit: seconds, s) are recorded.

[0090] (4) Slow muscle contraction holding period stability parameter (unit: seconds, s): Slow muscle relaxation time (unit: seconds, s):

[0091] (6) Pelvic floor muscle slow muscle function parameter (unit: seconds, s): C = c1C1 + c2C2, wherein c1, c2 are weighting coefficients, which are obtained through experiments.

[0092] 4. The subject relaxes for 30 seconds according to the template instructions, and obtains the pelvic floor muscle post-exercise stability parameter D (unit: microvolts, μV) and the pelvic floor muscle post-exercise baseline variability F corresponding to the position of each electrode piece.

[0093] Method:

[0094] (1) Record all muscle electrical values (unit: microvolts, μV) within 30 seconds as Q1, Q2, Q3, Q4,..., Q n .

[0095] (2) Resting baseline after exercise (unit: microvolts, μV)

[0096] (3) Muscle stability parameter after exercise (unit: microvolts, μV):

[0097] (4) Baseline variability parameter after exercise:

[0098] Step two specifically includes: removing the electrode ring outside the main body, after setting the air bag ring, using the air bag ring to detect the pelvic floor pressure, and the subject sequentially performs the exercise according to the template instructions to obtain the pressure collection data; The pressure collection data includes the pelvic floor muscle fast muscle strength parameter G (unit: millimeters of mercury, mmHg), the pelvic floor muscle slow muscle strength parameter H (unit: millimeters of mercury, mmHg), the vaginal diameter (unit: millimeters, mm), and the vaginal tissue elasticity coefficient E (unit: millimeters of mercury per millimeter, mmHg / mm).

[0099] The specific process is as follows:

[0100] 1. Remove the electrode ring outside the main body, set the air bag ring, and then place the modular device with all air bags evacuated inside the subject's vagina. The subject relaxes according to the template instructions, and then fills the air bag of the air bag ring with gas at 1 ml / s. Stop inflating when 20 mmHg is reached, and obtain the vaginal diameter (unit: millimeters, mm) of each part.

[0101] The specific process is as follows:

[0102] (1) Record the inflation volume (unit: milliliter, ml) of each balloon when reaching 20 mmHg, the inflation volume of the balloon at the 0 point, 3 points, 6 points, 9 points of the first circle from top to bottom is V 10 , V 13 , V 16 , V 19 , the second circle V 20 , V 23 , V 26 , V 29 , the third circle V 30 , V 33 , V 36 , V 39 , the fourth circle V 40 , V 43 , V 46 , V 49 , the fifth circle V 50 , V 53 , V 56 , V 59 , the sixth circle V 60 , V 63 , V 66 , V 69 .

[0103] (2) According to the inflation volume V of each balloon, the ring width record (unit: millimeter, mm) R 10 , R 13 , R 16 , R 19 ... R 69 is calculated according to the circular ring volume formula (the balloon inflation surface of the balloon ring is circular).

[0104] (3) The transverse diameter (unit: millimeter, mm) X1 of the vagina corresponding to the first balloon ring is X1=d+R 13 +R 19 ; the longitudinal diameter (unit: millimeter, mm) Y1 of the vagina is Y1=d+R 10 +R 16 , where d is the diameter of the cross section of the probe body; similarly, the transverse diameter X2, X3, X4, X5, X6 of the vagina corresponding to the second, third, fourth, fifth, sixth balloon ring and the longitudinal diameter Y2, P3, Y4, Y5, Y6 of the vagina are obtained.

[0105] According to the ring width record and the pressure 20 mmHg, the elasticity coefficient E (E=R / 20) (unit: millimeter of mercury per millimeter, mmHg / mm) of the vaginal tissue corresponding to the position of each balloon is calculated, and E 10 , E 13 , E 16 , E 19 ... E 69 is obtained.

[0106] 2, the subject according to the template instructions for 5 times the pelvic floor muscle quick contraction quick relaxation. Obtain the pelvic floor muscle quick muscle strength parameter G (unit: millimeter of mercury, mmHg) corresponding to the position of each air bag,

[0107] The specific process is:

[0108] (1) According to the time-pressure curve, record the data of each pressure peak (unit: millimeter of mercury, mmHg) as P1, P2, P3, P4, P5; When the subject contracts and relaxes, the software interface will display the time and corresponding pressure in real time, and draw a time-pressure curve;

[0109] (2) The pelvic floor muscle quick muscle strength parameter (unit: millimeter of mercury, mmHg) is:

[0110] 3, the subject according to the template instructions to hear the first instruction immediately after 1 times contraction and keep for 10s, then give the instruction to stop contraction immediately after relaxation for 10s, the second instruction immediately after 1 times contraction and keep for 10s, repeat a total of 5 times. Obtain the pelvic floor muscle slow muscle strength parameter H (unit: millimeter of mercury, mmHg) corresponding to the position of each air bag.

[0111] The specific process is:

[0112] (1) Record all pressure values (unit: millimeter of mercury, mmHg) for 8 seconds after 1 second of each instruction start as P'1, P'2, P'3, P'4,..., P' n .

[0113] (2) The stability parameter (unit: millimeter of mercury, mmHg) during each slow muscle contraction and keeping:

[0114] Obtain the stability parameter (unit: millimeter of mercury, mmHg) during the first, second, third, fourth and fifth slow muscle contraction and keeping H'1, H'2, H'3, H'4, H'5.

[0115] (3) The pelvic floor muscle slow muscle strength parameter (unit: millimeter of mercury, mmHg) is:

[0116] Step three specifically includes: in the circuit system framework of the base, using the pelvic floor muscle function parameter and pressure collection data for evaluation and analysis, obtaining the pelvic floor muscle state evaluation result, including the comprehensive score of pelvic floor muscle at each position, pelvic floor muscle movement coordination evaluation, pelvic floor muscle movement symmetry evaluation, vaginal longitudinal diameter, vaginal transverse diameter.

[0117] The comprehensive score result M of each position pelvic floor muscle is calculated and obtained by comprehensively calculating the pelvic floor muscle stability parameter A, the pelvic floor muscle fast muscle function parameter B, the pelvic floor muscle slow muscle function parameter C, the pelvic floor muscle stability parameter D after movement, the vaginal tissue elasticity coefficient E, the baseline variability F after pelvic floor muscle movement, the pelvic floor muscle fast muscle strength parameter G, and the pelvic floor muscle slow muscle strength parameter H. M=k1A+k2(B*G)+k3(C*H)+k4D+k5F+k6E+k7age, wherein age is the age of the subject, k1, k2, k3, k4, k5, and k6 are weighted coefficients, and the model is established and analyzed by using the data results of the previous clinical test. Finally, the M score of each position pelvic floor muscle is obtained, and then the M value is marked in the schematic diagram, and the final result is shown in Figure 7 .

[0118] The pelvic floor muscle movement symmetry is evaluated according to the comprehensive score result M of the 3-point and 9-point position pelvic floor muscle, and the result is shown in Figure 7 .

[0119] The pelvic floor muscle movement coordination is evaluated according to the fast muscle mobilization time B1, the fast muscle contraction time B2, and the fast muscle relaxation time B3 obtained by the electromyography of each position pelvic floor muscle, the sequence of the time is judged, and whether the force mode is correct is judged.

[0120] The vaginal longitudinal diameter and the vaginal transverse diameter are marked in the preset vaginal structure schematic diagram according to the X1, X2, X3, X4, X5, X6, Y1, Y2, Y3, Y4, Y5, Y6 corresponding to the 1st, 2nd, 3rd, 4th, 5th, 6th balloon ring according to the pelvic floor muscle force detection

balloon ring

[0121] The use method of the modular device for pelvic floor muscle state evaluation of the application further comprises: selecting and assembling the modular device according to the pelvic floor muscle state evaluation result, and respectively sleeving the electrode ring and the balloon ring on different port layers, so as to realize the balloon protection of the surgical scar part, the supplementary electric stimulation of the movement delay part, and the balloon inhibition of the movement early part.

[0122] For the person without the history of operation on the parts such as the vagina and the vulva, the fast muscle mobilization time B1, the fast muscle contraction time B2, and the fast muscle relaxation time B3 of each position pelvic floor muscle in the pelvic floor muscle evaluation stage are referred to the fast muscle mobilization time B1, the fast muscle contraction time B2, and the fast muscle relaxation time B3 of each position of the standard pelvic floor muscle movement template, the movement delay part and the movement early part are judged, the electrode ring is sleeved on the outer periphery of the port layer corresponding to the movement delay part, and the balloon ring is sleeved on the outer periphery of the port layer corresponding to the movement early part.

[0123] For those who have a history of surgery in the vagina, vulva and other parts, according to the fast muscle mobilization time B1, the fast muscle contraction time B2 and the fast muscle relaxation time B3 of each position of the pelvic floor muscle in the pelvic floor muscle evaluation stage, the fast muscle mobilization time B1, the fast muscle contraction time B2 and the fast muscle relaxation time B3 of each position of the standard pelvic floor muscle movement template are referred to, and the movement delay position and the movement too early position are judged. Then, the balloon ring is sleeved on the outer periphery of the port layer corresponding to the scar position, and then the electrode ring is sleeved on the outer periphery of the port layer corresponding to the movement delay position, and the balloon ring is sleeved on the outer periphery of the port layer corresponding to the movement too early position.

[0124] In some embodiments of the application, for vaginal lateral incision puerpera, the muscle high tension condition occurs in the part near the vaginal orifice due to scar contracture, and the stretching training cannot stimulate contraction, while the deep pelvic floor muscles will have relaxation type pelvic floor dysfunction for electrical stimulation treatment. The device assembly scheme is as shown in Figure 8 The balloon ring can be selected near the port layer of the main body base, and the electrode ring can be selected in the remaining positions, so that the pelvic floor muscles can be simultaneously subjected to electrical stimulation and stretching training. Since the muscles are in contact with each other, the muscles in the high tension state will also be stimulated when the muscles in the relaxation state are treated by electrical stimulation, which will aggravate the high tension state and aggravate the local pelvic floor dysfunction. However, in this scheme, the electrode ring and the balloon ring are selected for different positions, which can avoid such situations.

[0125] The modular device of the application can fully cope with various pelvic floor dysfunction diseases encountered in clinical practice. According to the selection of specific modules (electrode ring, balloon ring) for different positions of muscle dysfunction, a new vaginal probe can be assembled for diversified treatment. For example, for patients after surgery in the vagina, vulva and other parts, the balloon ring is used in the high tension part, and the electrical stimulation ring module is used in the relaxation part. During the electrical stimulation treatment of the relaxation part, the balloon is used to expand the high tension part, so as to inhibit contraction and avoid secondary damage. The device can assist doctors to better treat pelvic floor dysfunction diseases.

[0126] The application combines electromyographic detection and pressure detection. The electromyographic detection (sensitive electromyographic detection can find weak changes) is used to evaluate the reaction speed of the muscle and the stability of the muscle, the pressure detection (directly related to physiological activity) is used to evaluate the muscle strength, the pressure detection is used to evaluate the elasticity and inner diameter of the vagina, the pressure detection results and the electromyographic detection results are comprehensively scored, and the symmetry and coordination of the pelvic floor muscle movement are evaluated. The application has more clinical value in assisting doctors in diagnosis, and can not only guide rehabilitation training, but also serve as a reference before surgery.

[0127] The above merely describes the preferred embodiments of the present application, and it should be pointed out that those skilled in the art can make several improvements and refinements without departing from the principles of the present application, and these improvements and refinements should also be considered as the protection scope of the present application.

Claims

1. A modular device for pelvic floor muscle status assessment, characterized by: The probe body (1), the electrode ring (2) and the air bag ring (3) are included. The probe body (1) is a hollow structure, and is divided into a head part (11), a main body part (12), a base part (13) and a handheld part (14) from top to bottom, and the probe body (1) is made of hard material; the top end of the head part (11) is hemispherical, and the head part (11) is connected with the main body part (12) by a rotary dismounting mode; the main body part (12) is a long cylindrical body, and a longitudinal groove (121) is arranged on the surface of the main body part (12) from top to bottom, and is used for connecting a corresponding protrusion (4) on the air bag ring (3) or the electrode ring (2); a plurality of layers of port layers are arranged on the main body part (12) from top to bottom, each layer of port layers includes a plurality of pairs of ports, and each pair of ports includes an electrode interface and a gas hole interface; the electrode ring (2) or the air bag ring (3) is detachably arranged on the outer periphery of each layer of port layers, the base part (13) is an umbrella-like structure, and the inside of the base part (13) is a circuit system for processing electromyographic information and pressure information; and the handheld part (14) is a cylindrical body, and has a thread on the surface. The electrode ring (2) is a hollow annular hard structure, and electrode pads are uniformly distributed on the outer side of the electrode ring (2); each electrode pad has an electrode port at a position corresponding to the center point of the electrode pad on the inner side of the ring, and the electrode port is used for connecting the electrode interface on the surface of the probe body (1); and the inner side of the electrode ring (2) further has a protrusion (4) for connecting the groove (121) on the surface of the main body part (12), so as to fix the electrode ring (2) and the probe body (1). The air bag ring (3) is a hollow annular hard structure, and air bags are uniformly distributed on the outer side of the air bag ring (3); each air bag has a gas charging and discharging port at a position corresponding to the center point of the air bag on the inner side of the ring, and the gas charging and discharging port is used for connecting the gas hole interface of the probe body; and the inner side of the air bag ring (3) further has a protrusion (4) for connecting the groove (121) on the surface of the main body part (12), so as to fix the air bag ring (3) and the probe body (1). The circuit system includes a main control module, a signal acquisition module, a power supply module, a wireless communication module, a gas charging and discharging driving module and an electric stimulation driving module; the signal acquisition module includes a pressure sensor module, a flow sensor module, an electromyographic sensor module and an analog-to-digital conversion module; the signal acquisition module converts the electromyographic signals collected by the electrodes and the pressure signals collected by the air bags into electric signals and transmits the electric signals to the main control module; the power supply module is used for providing a current with specific parameters for the main control module, the signal acquisition module, the electric stimulation driving module, the gas charging and discharging driving module and the wireless communication module; the wireless communication module is used for establishing a connection between the main control unit and a terminal; the main control module transmits information analyzed and processed to the terminal; the terminal transmits instructions to the main control module; the main control module transmits the instructions to the electric stimulation driving module and / or the gas charging and discharging driving module according to the received information; then the electric stimulation driving module and / or the gas charging and discharging driving module controls the electrode pads on the electrode ring and / or the air bags on the air bag ring to execute electric stimulation and / or gas charging and discharging instructions. The signal acquisition module converts the electromyographic signals collected by the electrodes and the pressure signals collected by the air bags into electric signals and transmits the electric signals to the main control module; the main control module transmits information analyzed and processed to the terminal; and the information includes: The electrode ring is used for pelvic floor muscle electromyography detection, the electromyography is drawn by collecting the electromyography value changing with time, and the pelvic floor muscle function parameters are obtained, the pelvic floor muscle function parameters include pelvic floor muscle stability parameter A, pelvic floor muscle fast muscle function parameter B, pelvic floor muscle slow muscle function parameter C, pelvic floor muscle stability parameter D after movement and baseline variability F after pelvic floor muscle movement. The airbag ring is used for pelvic floor pressure detection, and pressure collection data is obtained; the pressure collection data includes pelvic floor muscle fast muscle strength parameter G, pelvic floor muscle slow muscle strength parameter H, vaginal diameter and vaginal tissue elasticity coefficient E.

2. The modular device for pelvic floor muscle status assessment according to claim 1, characterized in that: The electrode ring (2) is distributed with at least four electrode pieces outside, the center points of each electrode are spaced apart by 90 degrees, and are respectively located at 0 o'clock, 3 o'clock, 6 o'clock and 9 o'clock clock positions; the airbag ring (3) is distributed with at least four airbags outside, the airbags are expanded after being inflated, the center points of each airbag are spaced apart by 90 degrees, and are respectively located at 0 o'clock, 3 o'clock, 6 o'clock and 9 o'clock clock positions, and there is a certain distance between each airbag.

3. The modular device for pelvic floor muscle status assessment according to claim 1, characterized in that: The main body part (12) is distributed with six layers of port layers from top to bottom, each layer includes at least four pairs of ports, each pair of ports is spaced apart by 90 degrees, and the four pairs of ports are respectively located at 0 o'clock, 3 o'clock, 6 o'clock and 9 o'clock clock positions, and each pair of ports includes one electrode interface and one air hole interface.

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