Pelvic floor muscle repair instrument, electrode control method, electronic equipment and medium

Abstract

The invention discloses a pelvic floor muscle repairing instrument, an electrode control method, electronic equipment and a medium, and the pelvic floor muscle repairing instrument comprises a main body part which is provided with an electrode array; the electrical stimulation circuit is connected with the signal acquisition circuit; the switch array is connected with the electrode array, the electrical stimulation circuit and the signal acquisition circuit; and the controller is respectively connected with the electrical stimulation circuit, the signal acquisition circuit and the switch array. The controller is configured to determine an electrode configuration scheme for defining the acquisition electrode subset and the stimulation electrode subset according to the acquired electromyographic signals and a pre-stored electrode layout scheme; according to the scheme, the switch array is controlled, and each electrode in the electrode array is dynamically switched to a corresponding state of being connected with the electrical stimulation circuit, connected with the signal acquisition circuit or disconnected. According to the scheme, software reconfiguration and hardware dynamic switching of an electrode function are realized, so that partitioned accurate evaluation and targeted stimulation can be performed on pelvic floor muscles according to a real-time evaluation result, and individualization and accuracy of rehabilitation treatment are improved.

Description

Technical Field

[0001] This application relates to the field of postpartum rehabilitation equipment technology, specifically to a pelvic floor muscle repair device, an electrode control method, electronic equipment, and a medium. Background Technology

[0002] Pelvic floor muscle rehabilitation training is an important means of improving pelvic floor function in clinical settings such as postpartum rehabilitation for modern women and urinary continence training for the elderly. The accurate evaluation of its training effect is of key significance for improving the quality of rehabilitation.

[0003] Existing pelvic floor muscle repair devices typically employ electrodes with fixed functions, some dedicated to applying electrical stimulation and others to collecting electromyographic signals. This physically fixed design has limitations. In practice, the type, extent, and location of pelvic floor muscle injuries vary significantly among patients, and the fixed electrodes cannot dynamically adjust their role and area of ​​action based on individualized assessments during treatment. This may result in stimulation energy not being precisely applied to the truly weak muscle groups, or the collected signals not covering all areas requiring assessment, thus affecting the targetedness, adaptability, and overall effectiveness of rehabilitation treatment.

[0004] The preceding description is intended to provide general background information and does not necessarily constitute prior art. Summary of the Invention

[0005] This application provides a pelvic floor muscle repair device, electrode control method, equipment, and medium, which can solve the problem that the function of electrodes in the prior art is fixed and cannot be dynamically adjusted according to individualized assessment results, resulting in a lack of precision and adaptability in treatment.

[0006] In a first aspect, embodiments of this application provide a pelvic floor muscle repair device, the pelvic floor muscle repair device comprising: The main body is used for insertion or placement into the corresponding part of the pelvic floor muscles, and the main body is provided with an electrode array including at least two electrodes; An electrical stimulation circuit for generating at least one electrical stimulation signal; Signal acquisition circuit, used to acquire electromyographic signals; A switch array, connected to the electrode array, the electrical stimulation circuit, and the signal acquisition circuit; and The controller is connected to the electrical stimulation circuit, the signal acquisition circuit, and the switch array, respectively. The switch array is used, under the control of the controller, to switch the corresponding electrode to the electrostimulation circuit so that the electrode is switched to the stimulation electrode state, or to switch it to the signal acquisition circuit so that the electrode is switched to the acquisition electrode state, or to disconnect it from both the electrostimulation circuit and the signal acquisition circuit and be in a floating state. The controller is configured as follows: An electrode configuration scheme is determined based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme; wherein, the electrode configuration scheme is used to define a first subset of electrodes in the acquisition electrode state and a second subset of electrodes in the stimulation electrode state; The switching state of the switch array is controlled according to the electrode configuration scheme.

[0007] In one possible design, the switch array includes at least two switch units, each switch unit being connected to one electrode in the electrode array.

[0008] In one possible design, the electrical stimulation circuit includes one or at least two electrical stimulation units, each corresponding to a stimulation channel, and each stimulation channel outputs an electrical stimulation signal. When the electrical stimulation circuit includes an electrical stimulation unit, the electrical stimulation unit is connected to all the switching units in the switch array; When the electrical stimulation circuit includes at least two electrical stimulation units, each electrical stimulation unit is connected to at least one switching unit in the switch array.

[0009] In one possible design, the controller is also configured to: When the switch array is controlled to switch any one of the electrodes between the stimulation electrode state and the acquisition electrode state, a protection time window of a preset duration is inserted. During the protection time window, the electrode is controlled to switch to a suspended state.

[0010] In one possible design, the preset duration is between 50 milliseconds and 100 milliseconds.

[0011] In one possible design, the signal acquisition circuit includes at least two independent signal acquisition units; each signal acquisition unit corresponds to an electrode and a stimulation channel, and each acquisition channel includes a preamplifier, a bandpass filter, and an analog-to-digital converter connected in sequence; the input of the preamplifier is connected to the corresponding electrode via the switch array, and its common-mode rejection ratio is greater than 100 dB; the passband frequency range of the bandpass filter is 20 Hz to 450 Hz; and the output of the analog-to-digital converter is connected to the controller. The controller is further configured as follows: The electromyographic signals from the bandpass filter are denoised using template matching or subtraction.

[0012] In one possible design, each switch unit in the switch array includes: a first switch terminal, a second switch terminal, a third switch terminal, a common terminal, and a control terminal; The first switch terminal is connected to the output terminal of the corresponding electrical stimulation circuit, the second switch terminal is connected to the input terminal of the acquisition channel in the signal acquisition circuit, the common terminal is connected to the corresponding electrode, the control terminal is connected to the controller, and the third switch terminal is grounded or in a high-impedance state. When the common terminal is connected to the first switch terminal, the corresponding electrode is in the stimulation electrode state; when the common terminal is connected to the second switch terminal, the corresponding electrode is in the acquisition electrode state; when the common terminal is connected to the third switch terminal, the corresponding electrode is in the floating state.

[0013] In one possible design, the pelvic floor muscle repair device further includes a display unit connected to the controller; The controller is also configured to display a visualization interface of the electrode layout scheme on the display unit.

[0014] In one possible design, the controller is further configured to: perform a functional assessment of the pelvic floor muscles based on the electromyographic signals acquired by the signal acquisition circuit to obtain an assessment result, and configure the stimulation parameters of each electrode in the second electrode subset based on the assessment result; The stimulation parameters include: waveform type, stimulation intensity, pulse frequency, and pulse width; wherein the adjustable range of the stimulation intensity is 0 to 50 mA, the adjustable range of the pulse frequency is 1 to 100 Hz, and the adjustable range of the pulse width is 50 to 500 μs.

[0015] In one possible design, the controller is further configured to control the electrical stimulation circuit to output an electrical stimulation signal through the electrodes in the stimulation electrode state in at least one of the following modes: The rotation mode activates different stimulation electrodes or groups of stimulation electrodes in turn. Cross mode, which alternately activates two stimulating electrodes or groups of stimulating electrodes corresponding to synergistic or antagonistic muscle groups; Synchronization mode: Simultaneously activates multiple or all of the stimulation electrodes.

[0016] In one possible design, the controller is configured to perform a functional assessment of the pelvic floor muscles by performing the following steps to obtain an assessment result: Based on the electromyographic signals acquired through electrodes in the acquisition state, the electromyographic signal intensity index of each acquisition channel and the synergy index between signals of different channels are calculated. An evaluation result is generated based on the electromyographic signal intensity index and the synergy index.

[0017] In one possible design, the electromyographic signal intensity index is the root mean square value of the signal, and the synergy index is the correlation coefficient or mutual information between channel signals.

[0018] In one possible design, the controller is also configured to: If the electromyographic signal intensity index is lower than a first threshold in a preset first number of channels, it is determined to be a global relaxation-type injury. If the electromyographic signal intensity index is significantly lower than that of the adjacent channels in a preset second number of channels, it is determined to be a localized weak injury. If the difference in electromyographic signal intensity or synergy index between the symmetrically arranged left and right channels exceeds the second threshold, it is determined to be a unilateral injury. If the overall level of the synergy index is lower than the third threshold, it is determined to be a synergy disorder type of injury.

[0019] In one possible design, the evaluation results include: muscle strength maps; The controller is configured to generate the muscle strength map through the following steps: Map the anatomical location corresponding to each acquisition channel to a preset pelvic floor muscle group spatial diagram; The electromyographic signal intensity indicators of each acquisition channel are visualized and rendered in a color-coded manner at the corresponding positions in the spatial diagram to generate a two-dimensional muscle strength map.

[0020] In one possible design, the controller is also configured to: Based on the muscle strength map, weak functional areas were identified; When determining the electrode configuration scheme, the electrode covering the functionally weak area is configured as the stimulation electrode.

[0021] In one possible design, the controller is configured to determine the electrode layout scheme by at least one of the following methods: Load the pre-stored standard layout template as the electrode layout scheme; The display unit guides users to perform specific pelvic floor muscle contraction movements, and establishes an electrode layout scheme that represents the correspondence between electrodes and anatomical locations based on the characteristics of the collected electromyographic signal response. By measuring the bioimpedance characteristics between electrodes and comparing the generated impedance characteristics with a pre-stored tissue impedance model, an electrode layout scheme representing the contact position of each electrode is obtained.

[0022] Secondly, embodiments of this application provide an electrode control method, including: An electrode configuration scheme is determined based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme; wherein, the electrode configuration scheme is used to define a first subset of electrodes in the acquisition electrode state and a second subset of electrodes in the stimulation electrode state; According to the electrode configuration scheme, the switching state of each switching unit in the switching array is controlled.

[0023] In one possible design, determining the electrode configuration scheme based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme includes: Determine the electrode layout scheme, which is used to indicate the placement position of each electrode in the electrode array; Based on the electromyographic signals acquired through the signal acquisition circuit, the pelvic floor muscles are functionally assessed to obtain the assessment results. Based on the evaluation results and the electrode layout scheme, an electrode configuration scheme is determined.

[0024] In one possible design, determining the electrode configuration scheme based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme includes: Determine the electrode layout scheme, which is used to indicate the placement position of each electrode in the electrode array; Based on the electromyographic signals acquired through the signal acquisition circuit, the pelvic floor muscles are functionally assessed to obtain the assessment results. Based on the evaluation results and the electrode layout scheme, an electrode configuration scheme is determined.

[0025] In one possible design, the method further includes: When the switch array is controlled to switch any one of the electrodes between the stimulation electrode state and the acquisition electrode state, a protection time window of a preset duration is inserted. During the protection time window, the electrode is controlled to switch to a suspended state.

[0026] In one possible design, the method further includes: The electrical stimulation circuit is controlled to output electrical stimulation signals through the electrodes in the stimulation electrode state in at least one of the following modes: The rotation mode activates different stimulation electrodes or groups of stimulation electrodes in turn. Cross mode, which alternately activates two stimulating electrodes or groups of stimulating electrodes corresponding to synergistic or antagonistic muscle groups; Synchronization mode: Simultaneously activates multiple or all of the stimulation electrodes.

[0027] In one possible design, the assessment of the pelvic floor muscles based on the electromyographic signals acquired through the signal acquisition circuit to obtain the assessment result includes: Based on the electromyographic signals acquired through electrodes in the acquisition state, the electromyographic signal intensity index of each acquisition channel and the synergy index between signals of different channels are calculated. An evaluation result is generated based on the electromyographic signal intensity index and the synergy index.

[0028] In one possible design, the method further includes: If the electromyographic signal intensity index is lower than a first threshold in a preset first number of channels, it is determined to be a global relaxation-type injury. If the electromyographic signal intensity index is significantly lower than that of the adjacent channels in a preset second number of channels, it is determined to be a localized weak injury. If the difference in electromyographic signal intensity or synergy index between the symmetrically arranged left and right channels exceeds the second threshold, it is determined to be a unilateral injury. If the overall level of the synergy index is lower than the third threshold, it is determined to be a synergy disorder type of injury.

[0029] In one possible design, the evaluation results include: muscle strength maps; The muscle strength map is generated through the following steps: Map the anatomical location corresponding to each acquisition channel to a preset pelvic floor muscle group spatial diagram; The electromyographic signal intensity indicators of each acquisition channel are visualized and rendered in a color-coded manner at the corresponding positions in the spatial diagram to generate a two-dimensional muscle strength map.

[0030] In one possible design, the method further includes: Based on the muscle strength map, weak functional areas were identified; When determining the electrode configuration scheme, the electrode covering the functionally weak area is configured as the stimulation electrode.

[0031] In one possible design, the electrode layout scheme is determined by at least one of the following methods: Load the pre-stored standard layout template as the electrode layout scheme; The display unit guides users to perform specific pelvic floor muscle contraction movements, and establishes an electrode layout scheme that represents the correspondence between electrodes and anatomical locations based on the characteristics of the collected electromyographic signal response. By measuring the bioimpedance characteristics between electrodes and comparing the generated impedance characteristics with a pre-stored tissue impedance model, an electrode layout scheme representing the contact position of each electrode is obtained.

[0032] Thirdly, embodiments of this application provide an electronic device, including: a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor executes the computer program to implement the steps of the electrode control method as described in the second aspect.

[0033] Fourthly, embodiments of this application provide a storage medium storing a computer program that can be loaded by a processor and executed as described in the second aspect of the electrode control method.

[0034] This application's pelvic floor muscle repair device utilizes a hardware combination of an electrode array containing multiple electrodes and a programmable switch array. Under the unified scheduling of a controller, it achieves dynamic reconstruction of the electrode functional states. Specifically, the controller first analyzes the electromyographic signals acquired by the signal acquisition circuit and the known electrode layout scheme to generate a clear electrode configuration scheme. This scheme defines a first subset of electrodes for signal acquisition and a second subset of electrodes for applying electrical stimulation. Subsequently, the controller controls the switch array according to this scheme, switching the physical electrode points in the electrode array in real time and flexibly as acquisition electrodes, stimulation electrodes, or suspended states. Thus, this application, through a closed-loop control of "assessment-decision-reconstruction," enables the same set of electrode hardware to dynamically construct the optimal signal acquisition network and targeted stimulation network based on the individualized muscle function state assessed in real time, thereby achieving refined zonal assessment and spatially oriented treatment of the pelvic floor muscles. This not only solves the problem of lack of specificity and adaptability in treatment caused by the fixed electrode functions in existing technologies, but also avoids overstimulation of healthy muscle groups, optimizes the distribution of treatment energy, and ultimately improves the accuracy, safety, and overall effectiveness of rehabilitation treatment. Attached Figure Description

[0035] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of the main body of the pelvic floor muscle repair device provided in the embodiments of this application; Figure 2 This is a schematic diagram of the pelvic floor muscle repair device provided in the embodiments of this application; Figure 3 This is a schematic diagram of the structure of the electrical stimulation circuit provided in the embodiments of this application; Figure 4 This is another schematic diagram of the electrical stimulation circuit provided in the embodiments of this application; Figure 5This is another schematic diagram of the electrical stimulation circuit provided in the embodiments of this application; Figure 6 This is a schematic diagram of the signal acquisition circuit provided in an embodiment of this application; Figure 7 This is a schematic diagram of the structure of the switching unit in the switching array provided in the embodiments of this application; Figure 8 This is a schematic flowchart of the electrode control method provided in the embodiments of this application; Figure 9 This is a schematic diagram of the electrode control device provided in the embodiments of this application; Figure 10 This is a schematic diagram of the structure of the electronic device provided in the embodiments of this application. Detailed Implementation

[0037] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of systems and methods consistent with those detailed in the appended claims or with some aspects of this application.

[0038] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover descriptions such as non-exclusive inclusion, so that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. Furthermore, components, features, and elements with the same names in different embodiments of this application may have the same meaning or different meanings, the specific meaning of which must be determined by its interpretation in that specific embodiment or further in conjunction with the context of that specific embodiment.

[0039] It should be understood that the specific embodiments described herein are merely illustrative of this application and are not intended to limit this application.

[0040] In the following description, the use of suffixes such as "module," "part," or "unit" to denote elements is solely for the purpose of illustration and has no specific meaning in itself. Therefore, "module," "part," or "unit" may be used interchangeably.

[0041] To address the aforementioned technical problems and overcome the shortcomings of existing technologies, this application provides a pelvic floor muscle repair device, electrode control method, apparatus, equipment, and medium, which can quantitatively assess the effectiveness of pelvic floor muscle training and compensatory interference, and guide training based on the assessment results, thereby improving the quality and efficiency of pelvic floor muscle rehabilitation training.

[0042] like Figure 1 , 2 As shown, Figure 1 This is a schematic diagram of the structure of a pelvic floor muscle repair device in one embodiment. Figure 2 This is a schematic diagram of the circuit structure of a pelvic floor muscle repair device in one embodiment. The pelvic floor muscle repair device in this application embodiment may include: a main body 1, an electrode array 2, a controller 3, an electrical stimulation circuit 4, a signal acquisition circuit 5, and a switch array 6.

[0043] The main body 1 is used to insert or place into the area corresponding to the pelvic floor muscles, which can refer to the vagina or rectum.

[0044] It should be noted that, based on the position and method of action of the main body 1, pelvic floor muscle repair devices can be mainly divided into two product forms: in-body and non-in-body. This application embodiment uses the in-body type as an example for illustration. In the in-body type, the main body 1 is inserted into the corresponding part of the pelvic floor muscles during use. It is worth noting that the solution of this application also applies to the non-in-body type, and this application does not limit it in this regard. For non-in-body pelvic floor muscle repair devices, the main body of this type of product is placed on the pelvic floor muscles. The specific product form can be a cushion, a seat cushion, or other non-in-body products.

[0045] The main body 1 can be made of, but is not limited to, one of the following materials: medical-grade ABS (Acrylonitrile Butadiene Styrene) plastic, medical-grade polycarbonate (PC), and medical-grade silicone composite material. Medical-grade ABS plastic has good biocompatibility, is non-allergenic, and can come into direct contact with human skin; it also has high mechanical strength, can stably fix various functional modules, and has a smooth surface that is easy to clean and disinfect, making it suitable for the frequent cleaning needs in medical settings. Medical-grade polycarbonate (PC) has good light transmittance, excellent impact resistance, a wide range of high and low temperature resistance, can adapt to temperature changes in different clinical environments, and also meets medical-grade biocompatibility standards.

[0046] like Figure 1As shown, the main body 1 is rod-shaped, tapering at both ends and thickening in the middle, gradually tapering at the front end to form a smooth, blunt or ellipsoidal head. This ensures smooth insertion and allows easy passage through narrow passages, minimizing user discomfort and potential tissue damage. The middle section is the thickest part of the main body, forming the functional main area. Its increased diameter ensures that the electrodes on its surface can generate sufficient and uniform contact area with the target area of ​​the pelvic floor muscles, providing a physical basis for effective electrical stimulation and signal acquisition. The rear end gradually tapers compared to the middle section and is usually designed with an anti-slip structure or an interface for connecting to the handle, facilitating user grip or device fixation.

[0047] The controller 3, as the control core, can be a microcontroller unit, a digital signal processor, a programmable logic device, or an embedded computer system including a processor and memory. The controller 3 can be located inside the housing of the pelvic floor muscle repair device and directly electrically connected to the internal circuit board; alternatively, it can be placed outside the housing as an independent external device. When the controller 3 is located externally, it exchanges data and transmits control commands to the main circuit inside the housing via a wired communication interface or a wireless communication module. Wired communication methods can include USB (Universal Serial Bus), Ethernet, or a dedicated serial bus; wireless communication methods can include Bluetooth, Wi-Fi (Wireless Fidelity), or ZigBee. Regardless of its specific form and location, the controller 3 is configured to perform the signal processing, scheme decision-making, and device control functions described in this application.

[0048] The first electrode 21 and the second electrode 22 are disposed on the main body 1. For example, the first electrode 21 and the second electrode 22 are respectively disposed on opposite sides of the outer peripheral surface of the main body 1. The first electrode 21 and the second electrode 22 can be flexible electrodes or metal electrodes coated with conductive silicone, etc., and the embodiments of this application do not limit this.

[0049] In this application, the first electrode 21 and the second electrode 22 can be switched to a stimulation electrode state, a data acquisition electrode state, or a suspended state under the independent control of the controller 3. In the stimulation electrode state, the electrode functions as a stimulation electrode to output electrical stimulation signals; in the data acquisition electrode state, it functions as a data acquisition electrode to acquire electromyographic signals; in the suspended state, the electrode is inactive. This application uses at least two electrodes, and the number can be increased according to clinical needs (such as multi-channel acquisition or improved signal redundancy) to adapt to rehabilitation training needs in different scenarios. Furthermore, the placement of each electrode on the main body 1 can be adjusted by the user according to actual needs.

[0050] See Figure 2Here is a schematic diagram of the pelvic floor muscle repair device provided in this application embodiment, including: The main body 1 is used for insertion or placement into the corresponding part of the pelvic floor muscles and is provided with an electrode array including at least two electrodes; Electrical stimulation circuit 4 is used to generate at least one electrical stimulation signal; Signal acquisition circuit 5 is used to acquire electromyographic signals; Switch array 6 is connected to electrode array, electrical stimulation circuit and signal acquisition circuit; Controller 3 is connected to the electrical stimulation circuit, the signal acquisition circuit, and the switch array, respectively; The switch array 6 is used, under the control of the controller, to switch the corresponding electrode to the electrical stimulation circuit so that the electrode is switched to the stimulation electrode state, or to switch it to the signal acquisition circuit so that the electrode is switched to the acquisition electrode state, or to disconnect it from both the electrical stimulation circuit and the signal acquisition circuit and be in a floating state. Specifically, the electrical stimulation circuit 4 responds to the instructions of the controller 3 to generate an electrical stimulation signal that conforms to certain stimulation parameters, and applies the electrical stimulation signal to one or more electrodes selected by the controller 3 through the switch array 6.

[0051] The electrical stimulation circuit 4 can be implemented based on a digital control architecture of a microcontroller or a dedicated waveform generator chip.

[0052] In one embodiment, the electrical stimulation circuit 4 includes: a digital control interface, a waveform generation unit, a digital-to-analog converter, a constant current output drive module, and a multiplexing and isolation module.

[0053] The digital control interface connects to controller 3 and receives instructions carrying stimulation parameters, including waveform type, stimulation intensity, pulse frequency, pulse width, and channel activation sequence. Waveform type refers to the basic shape of the current or voltage change over time in the stimulation pulse. Common types include biphasic symmetrical square waves, which consist of a positive pulse followed by a negative pulse of equal amplitude but opposite direction. This waveform design helps balance the charge within the tissue, reducing electrolytic effects and tissue polarization, thus improving treatment comfort and safety. Other waveforms, such as asymmetric waves or sinusoidal modulated waves, can also be selected according to the treatment objective. Stimulation intensity refers to the current amplitude output by each pulse, measured in milliamperes (mA). In constant current output mode, this parameter directly determines the perceived intensity of the stimulation and the degree of neuromuscular activation. The system achieves precise digital adjustment of the intensity through a precision digital-to-analog converter and a constant current source circuit, which is a key factor in controlling the stimulation dose. Pulse frequency is the number of stimulation pulses applied per second, measured in Hertz (Hz). The frequency determines the pattern of muscle contraction: lower frequencies help induce single tetanic contractions to strengthen muscle strength, while higher frequencies are more likely to induce tetanic fusion contractions, used for endurance or synergistic training. Frequency is an important timing parameter that can be programmably adjusted. Pulse width refers to the duration of a single stimulus pulse (such as one phase in a biphasic waveform), usually measured in microseconds. Pulse width and stimulus intensity together determine the amount of charge injected into biological tissue by each pulse, and are one of the key parameters affecting stimulus energy and neural activation threshold. Adjusting the pulse width allows for fine-tuning of the perception and effect of stimulation at a fixed intensity. Channel activation sequence refers to the temporal order and interrelationship of the opening and closing of individual stimulation channels in a multi-channel stimulation system. This sequence control enables the system to achieve various advanced stimulation modes such as rotation, crossover, or synchronization. By precisely arranging the stimulation windows and intervals of different channels, orderly or synergistic training can be performed on specific areas of the pelvic floor muscles, which is the core of achieving spatially targeted and temporally coordinated treatment.

[0054] The waveform generation unit generates a corresponding digital waveform sequence based on received instructions. A digital-to-analog converter (DAC) converts the digital sequence output from the waveform generation unit into an analog voltage reference signal. The DAC has sufficient accuracy (e.g., 12 bits or higher) to ensure fine adjustment of the stimulation intensity. The constant current output drive module receives the voltage reference from the DAC and converts it into a controlled constant current source output. This ensures that the stimulation current applied to the target muscle group remains constant even when the impedance of human tissue changes, thus guaranteeing the accuracy and consistency of the therapeutic dose. The constant current output range is typically designed to be adjustable from 0 to 50 mA to meet different clinical needs, from sub-sensory threshold stimulation to tetanic contraction. The multiplexing and isolation module is responsible for distributing one or more waveform generation signals to 4 to 8 independent stimulation channels supported by the system. Each stimulation channel contains an independent DAC and constant current drive, or shares a signal source under timing control via a high-speed analog switch.

[0055] The signal acquisition circuit 5 is responsible for acquiring, in real time, the microvolt-level electromyographic (EMG) signals generated by the pelvic floor muscles in resting, contraction, and stimulus response states through the acquisition electrodes selected by the controller 3, and converting them into digital signals that can be quantitatively analyzed by the controller. The signal acquisition circuit 5 typically consists of a multi-channel parallel high-performance preamplifier, a bandpass filter, and an analog-to-digital converter (ADC). The preamplifier must have extremely high input impedance and a common-mode rejection ratio exceeding 100 dB to effectively pick up and suppress common-mode interference from the human body. The subsequent bandpass filter typically sets the passband range to 20 Hz to 450 Hz to retain the effective spectral components of the EMG signal and filter out baseline drift and power frequency noise. Finally, the analog-to-digital converter digitizes the analog signal at a sampling rate of no less than 1000 Hz. Each acquisition channel is controlled by the same synchronous clock to ensure time alignment of multiple signals, thus providing an accurate data foundation for subsequent collaborative analysis and muscle strength mapping. The output of the signal acquisition circuit 5 is connected to the controller 3.

[0056] The switch array 6, under the real-time control of the controller 3, dynamically and programmably switches each individual electrode in the electrode array 2 to the signal acquisition circuit 5, the electrical stimulation circuit 4, or disconnects them. This enables flexible configuration and rapid switching of acquisition and stimulation electrodes at the hardware level, supporting selective assessment and targeted stimulation of different pelvic floor muscle zones. For example, the switch array 6 can employ an electromagnetic relay matrix, using the controller's GPIO (General Purpose Input / Output) interface to drive relay coils. Channel connection is achieved through relay contact switching, a method particularly suitable for scenarios requiring high voltage isolation and high current paths.

[0057] In one possible embodiment, the switch array 6 includes at least two switch units, each connected to one electrode in the electrode array. For example, the switch units employ multiple single-pole three-throw analog switch integrated circuits, with a common terminal of each switch unit connected to a corresponding electrode. The three switch terminals are respectively connected to the input of the signal acquisition circuit 5, the output of the electrical stimulation circuit 4, and a reference ground or a high-impedance state. The controller 3 sends control words to the switch units via a digital bus to simultaneously or sequentially set the connection state of all electrodes. Regardless of the specific devices used, this switch array ensures electrical isolation between channels and synchronization of switching actions, serving as the underlying hardware foundation for the system to achieve staggered acquisition-stimulation timing, multiple stimulation modes, and adaptive electrode configuration schemes.

[0058] The state of an electrode acquisition refers to the state in which a particular electrode is switched to the input terminal of a signal acquisition circuit via a corresponding switch unit in the switch array. In this state, the electrode functions as a bioelectrical signal sensor, used to pick up surface electromyographic signals generated by the pelvic floor muscles at the point of contact with the electrode.

[0059] The stimulation electrode state refers to the state in which an electrode is switched to the output of an electrical stimulation circuit via a switch array. In this state, the electrode acts as the application point for therapeutic energy, safely and effectively transmitting the programmable electrical pulses generated by the electrical stimulation circuit to the target muscle tissue, thereby inducing the desired neuromuscular contraction.

[0060] The suspended state refers to an electrode being electrically disconnected from both the input terminal of the signal acquisition circuit and the output terminal of the electrical stimulation circuit through the control of the switch array. Electrodes in this state are temporarily not used as functional electrodes in the system. This state can be used in various scenarios, such as temporarily excluding stimulation and monitoring of healthy or non-target muscle groups during treatment, selectively activating certain areas in a multi-electrode array to form a specific electric field distribution, or ensuring the passivity and safety of specific electrodes when system self-test and safety protection mechanisms are triggered. Controller 3 consists of a microprocessor unit, memory, and input / output interface circuitry.

[0061] Furthermore, controller 3 is configured as follows: The electrode configuration scheme is determined based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme; wherein, the electrode configuration scheme is used to define the first electrode subset in the acquisition electrode state and the second electrode subset in the stimulation electrode state.

[0062] Specifically, the system acquires electromyographic (EMG) signals uploaded by the signal acquisition circuit. These EMG signals correspond to an electrode layout scheme pre-stored in the controller's memory, which defines the mapping relationship between each physical electrode and a specific anatomical region of the pelvic floor muscles. The controller invokes its internally integrated signal processing algorithm to analyze the acquired EMG signals. This analysis typically includes calculating the temporal characteristics of the EMG signals from each effective acquisition channel, such as the root mean square (RMS) value, and further calculating synergy indices between signals from different channels, such as correlation coefficients. By comparing the analyzed feature values ​​with preset physiological thresholds or benchmark models, the controller identifies functionally weak areas, overactivated compensatory areas, and synergistic dysfunction areas within the pelvic floor muscle group. Based on this identification result, and combined with the spatial location information provided by the electrode layout scheme, the controller logic generates a specific electrode configuration scheme. The core of this scheme is defining two sets: a first subset of electrodes indicates which electrodes will be used for EMG signal acquisition in subsequent stages; and a second subset of electrodes indicates which electrodes will be used to apply targeted electrical stimulation. The designation of these two subsets is directly derived from the assessment of electromyographic signals, aiming to ensure that the acquisition range covers key monitoring areas and that the stimulation energy is precisely applied to the target muscle groups that need rehabilitation.

[0063] Based on the electrode configuration scheme, control the switching state of each switching unit in the switch array.

[0064] After the electrode configuration scheme is generated, the controller executes this step to implement the scheme. The controller's multi-channel timing scheduling module translates the scheme into a series of specific, low-level digital control instructions, each corresponding to a specific switching unit in the switch array. The state of each instruction directly determines whether the corresponding electrode will be switched to the acquisition electrode state, the stimulation electrode state, or the floating state. The output of the control instructions strictly follows a precise timing schedule. The timing schedule divides the system's working cycle into different stages, such as consecutive signal acquisition windows and electrical stimulation windows. Within the signal acquisition window, the controller outputs instructions to connect all electrodes in the first electrode subset to the signal acquisition circuit. In the immediately following electrical stimulation window, the controller outputs another set of instructions to connect the electrodes in the second electrode subset to the electrical stimulation circuit, and typically switches electrodes used only for acquisition to the floating state. The timing of the entire switching process is guaranteed by the controller's hardware timer, with millisecond-level accuracy, to ensure that stimulation and acquisition actions are accurately separated in time and to avoid mutual interference.

[0065] In one possible embodiment, the electrical stimulation circuit includes one electrical stimulation unit or at least two electrical stimulation units, each electrical stimulation unit corresponding to a stimulation channel, and each stimulation channel outputs an electrical stimulation signal. When the electrical stimulation circuit includes an electrical stimulation unit, the electrical stimulation unit is connected to all the switching units in the switch array; When the electrical stimulation circuit includes at least two electrical stimulation units, each electrical stimulation unit is connected to at least one switching unit in the switch array.

[0066] Specifically, when the electrical stimulation circuit includes a single electrical stimulation unit, this architecture represents a centralized resource allocation design. In this implementation, the system has only one independent electrical stimulation unit. This unit contains complete waveform generation, analog-to-digital conversion, and constant current output drive circuitry, capable of generating a single programmable electrical stimulation signal. This uniquely generated stimulation signal is routed to a switch array and connected to all the switch units within the array. By precisely controlling the switching states of each switch unit in the switch array, the controller can selectively guide this common stimulation signal in time and space to any one or more electrodes configured as stimulation electrodes.

[0067] For example, see Figure 3 The schematic diagram shows that the electrical stimulation circuit includes only one electrical stimulation unit 41, and the switch array includes three switch units: switch unit 61, switch unit 62, and switch unit 63. The electrode array includes electrode 21, electrode 22, and electrode 23. The electrical stimulation unit 41 is connected to switch units 61, 62, and 63 respectively. The electrical stimulation unit 41 can only output one electrical stimulation signal, which is delivered to the electrode in the stimulation electrode state by switching the switch array.

[0068] When the electrical stimulation circuit includes at least two electrical stimulation units, this architecture is a distributed parallel output design. In this implementation, the system has multiple independent electrical stimulation units, each of which is a fully functional stimulation signal generator capable of independently generating one electrical stimulation signal. Each such electrical stimulation unit is defined as an independent stimulation channel. The output of each electrical stimulation unit is connected to a subset (one or more) of the switching units in a switching array, thereby establishing a physical mapping relationship between the channel and a specific electrode or electrode group. The controller can independently set the stimulation parameters of each electrical stimulation unit and independently control its corresponding connected switching unit group. This enables the system to achieve parallel output of multiple stimulation signals.

[0069] For example, see Figure 4The schematic diagram shows that the electrical stimulation unit includes electrical stimulation unit 41 and electrical stimulation unit 42. The switch array includes switch unit 61, switch unit 62, and switch unit 63. The electrode array includes electrode 21, electrode 22, and electrode 23. Electrical stimulation unit 41 is connected to switch unit 61 and switch unit 62, respectively, and electrical stimulation unit 42 is connected to switch unit 63. When electrode 21 and electrode 22 are in the stimulation electrode state, one electrical stimulation signal output by electrical stimulation unit 41 can be output simultaneously through electrode 21 and electrode 22. When electrode 23 is in the stimulation electrode state, one electrical stimulation signal output by electrical stimulation unit 42 is output through electrode 23. The stimulation parameters of the two electrical stimulation signals can be configured independently.

[0070] For example, see Figure 5 The schematic diagram shows that the electrical stimulation unit includes electrical stimulation unit 41, electrical stimulation unit 42, and electrical stimulation unit 43. The switch array includes switch unit 61, switch unit 62, and switch unit 63. The electrode array includes electrode 21, electrode 22, and electrode 23. Electrical stimulation unit 41 is connected to switch unit 61, electrical stimulation unit 42 is connected to switch unit 62, and electrical stimulation unit 43 is connected to switch unit 63. When electrode 21, electrode 22, and electrode 23 are in the stimulation electrode state, the electrical stimulation signals output by the three electrical stimulation units can be applied to the corresponding electrodes respectively.

[0071] In one possible embodiment, controller 3 is further configured to: When the control switch array 2 switches any electrode between the stimulation electrode state and the acquisition electrode state, a preset protection time window is inserted; within the protection time window, the electrode is controlled to switch to the suspended state.

[0072] Specifically, the controller contains a timing management module that manages the precise sequence of all electrode state switching. When the controller needs to switch any electrode from its current state (e.g., stimulation electrode state) to another state (e.g., acquisition electrode state) according to the treatment process or mode scheduling, the timing management module does not directly issue a command to switch to the target state. Instead, it first executes an intermediate step. This step generates a set of control commands for the corresponding switching unit of the electrode, forcibly switching the electrode to a floating state, i.e., disconnecting it from both the signal acquisition circuit and the electrostimulation circuit. At the same time, the controller starts a hardware or software timer associated with the electrode to begin timing for a preset fixed duration, which is the protection time window. During the entire protection time window, the controller maintains the command that the electrode is in a floating state. Only after the protection time window ends and the timer issues a completion signal will the timing management module finally generate and output a second set of control commands, instructing the switching array to connect the electrode to the target functional circuit (i.e., the signal acquisition circuit or the electrostimulation circuit), thereby completing the entire switching process. The preset duration of the protection time window is usually determined by the characteristics of the system hardware, such as the physical switching time of the switching device, the saturation recovery time of the amplifier, and the dissipation time of the charge after the stimulation pulse. Its typical value is between 50 milliseconds and several hundred milliseconds.

[0073] In this way, by forcibly inserting a period of time during the process of switching the electrode from the stimulation state to the acquisition state (or vice versa), a completely electrically disconnected intermediate state of the electrode is achieved, thereby: firstly, completely eliminating the direct electrical impact and potential damage risk of the high-voltage stimulation pulse on the high-sensitivity, low-noise signal acquisition front end, ensuring the long-term safety and reliability of the acquisition circuit; secondly, providing sufficient discharge time for any residual charge in the stimulation circuit and allowing the acquisition circuit amplifier to fully recover from the previous large signal interference, avoiding the contamination of the weak electromyographic signals acquired subsequently by stimulation artifacts, and significantly improving the fidelity and accuracy of physiological signal acquisition.

[0074] In one possible embodiment, the signal acquisition circuit includes at least two independent signal acquisition units; each signal acquisition unit corresponds to an electrode and a stimulation channel, and each acquisition channel includes a preamplifier, a bandpass filter, and an analog-to-digital converter connected in sequence; the input of the preamplifier is connected to the corresponding electrode via a switch array, and its common-mode rejection ratio is greater than 100 dB; the passband frequency range of the bandpass filter is 20 Hz to 450 Hz; and the output of the analog-to-digital converter is connected to a controller. The controller is also configured as follows: Denoising of electromyographic signals from bandpass filters is performed using template matching or subtraction methods.

[0075] Specifically, the function of the preamplifier is to initially amplify the microvolt-level electromyographic (EMG) signals picked up by the electrodes and suppress common-mode interference to the greatest extent possible. Its implementation typically employs an instrumentation amplifier integrated circuit. This amplifier has extremely high input impedance, typically greater than 100 megohms, to reduce the load effect on the biological signal source. Its most critical performance indicator is the common-mode rejection ratio (CMRR), which in this scheme is required to be greater than 100 dB. This means it has extremely strong suppression capabilities against identical interference signals present at both input terminals, effectively extracting weak EMG differential signals buried in strong environmental noise. The amplifier gain is typically set to 100 to 1000 times, amplifying the signal to the millivolt level suitable for subsequent processing.

[0076] The function of a bandpass filter is to filter out noise components outside the frequency band of the electromyography (EMG) signal, including low-frequency body movement artifacts and baseline drift, as well as high-frequency electromagnetic interference and switching noise. It can be implemented using active filter circuits, such as multi-order Butterworth or Chebyshev filters constructed from operational amplifiers and resistor-capacitor networks. Its passband frequency range is set from 20 Hz to 450 Hz. The lower limit of 20 Hz aims to filter out most low-frequency movement and breathing artifacts, while the upper limit of 450 Hz aims to retain the main energy components of the EMG signal while removing high-frequency noise. The filter's roll-off characteristic needs to be sufficiently steep to ensure effective suppression of the 50 Hz power frequency and its harmonics.

[0077] The function of an analog-to-digital converter (ADC) is to convert amplified and filtered analog electromyography (EMG) signals into digital signals for storage, analysis, and processing by the controller. Specifically, it is implemented using a successive approximation or Σ-Δ ADC chip. Its resolution is typically no less than 16 bits to ensure sufficient quantization accuracy for signals with a large dynamic range. The sampling rate must satisfy the Nyquist sampling theorem; for effective signals up to 450 Hz, the sampling rate is usually set above 1000 Hz, and in practice, a sampling rate of 1000 to 2000 Hz is often chosen to preserve signal details while accommodating data volume. The input of the converter is connected to the output of a bandpass filter, and its digital output is directly connected to the controller's data input port via a parallel or serial interface. The controller provides the sampling clock and reads the conversion result.

[0078] The controller receives digitized electromyographic (EMG) signals from analog-to-digital converters in each signal acquisition unit. To improve signal quality for subsequent accurate analysis, the controller uses its internally stored noise reduction algorithm to process the signal, primarily based on template matching or subtraction. When using template matching, the controller first acquires a signal segment during a resting period without effective muscle contraction or a specific calibration phase. This segment mainly contains environmental noise, inherent equipment noise, and potentially stable stimulus artifacts, and stores it as a noise template in memory. During actual treatment acquisition, the controller compares the real-time acquired EMG signals with the stored noise template in the time or transform domain, identifying noise components highly similar to the template. The algorithm then suppresses or removes these noise components from the original signal, resulting in a purer EMG composition. Subtraction requires the system to have precise prior knowledge of the morphology and timing of interfering signals, such as in applications involving stimulus artifact elimination. The controller precisely generates a corresponding digital artifact template based on the known electrical stimulation pulse parameters. Then, it directly subtracts the waveform of this artifact template from the acquired mixed signal, aligning it temporally. Regardless of the method used, the core principle is to establish a reference model of the interference and identify and eliminate it in subsequent signals. After completing the noise reduction process, the controller sends the resulting clean electromyographic signal to the subsequent feature extraction and analysis module.

[0079] See Figure 6 The diagram shows a schematic of the signal acquisition circuit. The circuit has two acquisition channels, corresponding to signal acquisition unit 51 and signal acquisition unit 53 respectively. Signal acquisition unit 51 includes a preamplifier 511, a bandpass filter 512, and an analog-to-digital converter 513 connected in sequence. Signal acquisition unit 52 includes a preamplifier 521, a bandpass filter 522, and an analog-to-digital converter 523 connected in sequence. The preamplifier 511 of signal acquisition unit 51 is connected to electrode 21 via a switching unit 61, and the preamplifier 512 of signal acquisition unit 52 is connected to electrode 22 via a switching unit 62. When electrodes 21 and 22 are in the acquisition electrode state, the controller 3 acquires electromyographic signals from the two stimulation channels in parallel through signal acquisition units 51 and 52.

[0080] In one possible embodiment of this application, each switch unit in the switch array includes: a first switch terminal, a second switch terminal, a third switch terminal, a common terminal, and a control terminal; The first switch terminal is connected to the output terminal of the corresponding electrical stimulation circuit, the second switch terminal is connected to the input terminal of the acquisition channel in the signal acquisition circuit, the common terminal is connected to the corresponding electrode, the control terminal is connected to the controller, and the third switch terminal is grounded or in a high-impedance state. When the common terminal is connected to the first switch terminal, the corresponding electrode is in the stimulation electrode state; when the common terminal is connected to the second switch terminal, the corresponding electrode is in the acquisition electrode state; when the common terminal is connected to the third switch terminal, the corresponding electrode is in the floating state.

[0081] For details, see Figure 7 The schematic diagram of the switching unit shown is a single-pole three-throw analog switch, comprising a first switching terminal 612, a second switching terminal 613, a third switching terminal 614, a common terminal 611, and a control terminal 615. The first switching terminal 612 is connected to the output terminal of the electrical stimulation circuit to receive electrical stimulation signals; the second switching terminal 613 is connected to the input terminal of the corresponding acquisition channel in the signal acquisition circuit to transmit electromyographic signals; the common terminal 611 is directly connected to the corresponding electrode; the control terminal 615 is connected to the controller to receive switching commands; and the third switching terminal 614 is connected to system ground or is in a high-impedance state. The function of the switching unit is to selectively connect its common terminal to one of the first switching terminal 612, the second switching terminal 613, or the third switching terminal 614 according to the command sent by the controller through the control terminal. When the common terminal 611 is connected to the first switch terminal 612, an electrical stimulation signal is applied to the corresponding electrode, which is in the stimulation electrode state. When the common terminal 611 is connected to the second switch terminal 613, the physiological signal picked up by the electrode is transmitted to the acquisition channel, and the electrode is in the acquisition electrode state. When the common terminal 611 is connected to the third switch terminal 614, the electrode is disconnected from both the stimulation and acquisition circuits and is in a safe floating state, thereby realizing the programmable dynamic configuration of the function of each electrode at the hardware level.

[0082] In one possible embodiment, the pelvic floor muscle repair device further includes a display unit connected to a controller; the controller is also configured to display a visual interface of the electrode layout scheme on the display unit.

[0083] Specifically, the controller reads pre-stored data representing the electrode layout scheme from its non-volatile memory. This data defines the mapping relationship between the identifier of each electrode and its two-dimensional or three-dimensional spatial position on the pelvic floor muscle anatomy. Based on this mapping relationship, the controller's internal graphics processing module generates and renders a visual graphical interface on the display unit's screen. This interface contains a base diagram representing the outline of the pelvic floor muscles or electrode array carrier. The controller converts the identifier of each electrode (such as a number) and its corresponding spatial coordinates into specific graphic elements (such as dots or icons) on the screen and precisely draws them at the corresponding positions on the base diagram, thus forming a static electrode position distribution map. This allows the operator to clearly see the correspondence between the physical layout of the electrodes and the current electrical functional state.

[0084] In one possible embodiment, the controller is further configured to: perform a functional assessment of the pelvic floor muscles based on the electromyographic signals acquired by the signal acquisition circuit to obtain an assessment result, and configure the stimulation parameters of each electrode in the second electrode subset based on the assessment result. The stimulation parameters include: waveform type, stimulation intensity, pulse frequency, and pulse width; the adjustable range of stimulation intensity is 0 to 50 mA, the adjustable range of pulse frequency is 1 to 100 Hz, and the adjustable range of pulse width is 50 to 500 μs.

[0085] Specifically, the controller first performs time-domain and synergy analysis on the acquired multi-channel electromyography (EMG) signals. Time-domain analysis primarily calculates the root mean square (RMS) value of each channel signal within a specific assessment cycle, directly reflecting the contraction intensity of the corresponding muscle group. Synergy analysis calculates the correlation coefficient or mutual information between different channel signals to assess the coordination ability of different muscle groups during contraction. The controller compares the calculated RMS values ​​of each channel with preset intensity thresholds and simultaneously compares the synergy indices between channels with preset synergy benchmarks. Through these comparisons, the controller can identify three typical functional state areas in the pelvic floor muscles: first, functionally weak areas where EMG signal intensity is significantly below the threshold; second, synergistically dysfunctional areas where EMG signal intensity is normal or excessively high but synergy indices are poor; and third, over-activation compensatory areas where signal intensity may be excessively high and not the primary contraction target. This identified area information, combined with the electrode layout scheme, constitutes a quantitative assessment of pelvic floor muscle function. Subsequently, based on this assessment result, the controller configures specific stimulation parameters for each electrode (i.e., the target stimulation electrode) identified as a subset of the second electrodes. The core principle of the configuration is to provide differentiated stimulation for different functional states. For electrodes corresponding to functionally weak areas, the controller will be configured with higher stimulation intensity and moderate pulse frequency to effectively activate and strengthen weak muscle groups. For electrodes corresponding to areas of dyssynergism, the controller may be configured with moderate stimulation intensity but supplemented with specific pulse sequence timing, such as alternating with stimulation pulses from other channels, to train their synergistic rhythm. For healthy or compensatory areas identified during the assessment, even if their electrodes are located within a second subset, the controller may be configured with extremely low stimulation intensity or have its stimulation window shortened to avoid overstimulation. All parameters are set within the aforementioned adjustable range.

[0086] For example, in an assessment of a postpartum patient, the controller analyzed electromyographic signals and found that the root mean square value of the channel corresponding to the left levator ani muscle was only 15 microvolts, far below the intensity threshold of 30 microvolts, and its correlation coefficient with the contralateral channel was low, thus it was assessed as a functionally weak area. The channel corresponding to the right levator ani muscle had normal intensity, but poor synergy with other muscle groups on the same side, and was assessed as a synergistic dysfunction area. The controller included the electrodes corresponding to these two areas in a second electrode subset. The stimulation parameters configured for the electrode in the left weak area were: biphasic symmetrical square wave, stimulation intensity 35 mA, pulse frequency 30 Hz, and pulse width 300 microseconds, aiming for strong activation. The parameters configured for the electrode in the right synergistic dysfunction area were: biphasic symmetrical square wave, stimulation intensity 20 mA, pulse frequency 15 Hz, and pulse width 200 microseconds, and its stimulation pulse was set to alternate with the pulse of the left channel in time to train the coordination of alternating contractions of the left and right sides. All parameters are within the adjustable range of 0-50 mA, 1-100 Hz, and 50-500 microseconds.

[0087] In one possible embodiment, the controller is further configured to control the electrical stimulation circuit to output an electrical stimulation signal through the electrode in the stimulation electrode state in at least one of the following modes: The rotation mode activates different stimulation electrodes or groups of stimulation electrodes in turn. Cross mode, which alternately activates two stimulating electrodes or groups of stimulating electrodes corresponding to synergistic or antagonistic muscle groups; Synchronization mode: Simultaneously activates multiple or all of the stimulation electrodes.

[0088] Specifically, the controller executes the rotation mode as follows. In this mode, the controller arranges the multiple stimulation electrodes or predefined stimulation electrode groups contained in its determined second electrode subset in a predetermined order. The controller's timing scheduling module assigns an independent, non-overlapping activation window to each stimulation electrode or electrode group in the sequence. The controller strictly follows this order and timing plan, cyclically controlling the switch array and electrical stimulation circuit so that at any given time, only one stimulation electrode or electrode group is active and outputs an electrical stimulation signal. When the activation window of an electrode or electrode group ends, the controller first switches it to a suspended state, and after a necessary protection time, activates the next electrode or electrode group in the sequence. This process repeats continuously, forming a cyclically rotating stimulation sequence. For example, suppose the second electrode subset contains electrodes A, B, and C, and the controller sets a rotation mode. The controller sets the activation window for each electrode to 300 milliseconds, and the entire cycle is 900 milliseconds. Within the first 300 milliseconds, the controller activates only electrode A to output stimulation; then electrode A is turned off, and electrode B is activated for 300 milliseconds; then electrode B is turned off again, and electrode C is activated for 300 milliseconds; then a new cycle begins, activating electrode A again. Different zones are stimulated in turn in this manner.

[0089] The specific implementation process of the controller executing the cross-mode is as follows. In this mode, the controller divides the stimulating electrodes or electrode groups into two logical sets. These two sets typically correspond to muscle groups that have synergistic or antagonistic relationships anatomically or functionally, such as left and right sides, or anterior and posterior regions. The controller's timing scheduling module generates two sets of activation windows that alternate in time for these two sets. When the activation window of the first set is open, the controller activates all stimulating electrodes within that set to output stimulation; when this window closes, after a short interval, the activation window of the second set opens, and the stimulating electrodes within it are activated, while the electrodes of the first set are in a resting state. This alternating activation rhythm continues, forming a cross-working mode. For example, suppose the second electrode subset contains electrodes L1 and L2 corresponding to the left muscle group and electrodes R1 and R2 corresponding to the right muscle group. The controller sets the cross-mode, with one set for each side. The controller sets the activation window for each set to 400 milliseconds, and the interval between sets to 100 milliseconds. For the first 400 milliseconds, the controller activates electrodes L1 and L2 for stimulation; then the left electrode is deactivated, and after a 100-millisecond interval, the right 400-millisecond window is opened to activate electrodes R1 and R2; then the controller switches back to the left. In this way, the left and right muscle groups contract and relax alternately.

[0090] The specific implementation process of the controller executing the synchronization mode is as follows. In this mode, the controller defines all or part of the stimulation electrodes within its determined second electrode subset as a synchronization group. The controller's timing scheduling module generates a unified, common activation window for this synchronization group. When this activation window is open, the controller simultaneously sends instructions to all stimulation electrodes within the group, causing the electrical stimulation circuit to synchronously output electrical stimulation signals to these electrodes through a switch array. The stimulation parameters corresponding to these electrodes can be set to the same or different depending on the evaluation results, but their stimulation pulses are strictly synchronized in time. For example, suppose the second electrode subset includes electrodes P1 to P4, corresponding to the muscle groups that need overall strengthening. The controller sets the synchronization mode, including all four electrodes in a synchronization group. The controller opens an activation window lasting 500 milliseconds. Within this window, the controller controls the electrical stimulation circuit to simultaneously output electrical stimulation signals to electrodes P1, P2, P3, and P4, triggering synchronous contraction of all corresponding muscle group areas.

[0091] By implementing multiple programmable electrical stimulation modes, including alternating, cross-modal, and synchronous modes, this system can provide highly adaptive training strategies for different pathological characteristics and rehabilitation stages of pelvic floor muscle dysfunction. The alternating mode effectively avoids localized muscle fatigue and is suitable for initial zonal assessment and activation; the cross-modal mode facilitates training the coordination and balance between muscle groups, correcting imbalances in left-right or front-back strength; and the synchronous mode maximizes the synergistic contraction strength and control of the overall muscle groups. These three core modes, through flexible scheduling and combination by the controller, greatly enhance the targeted, scientific, and personalized level of rehabilitation training.

[0092] In one possible embodiment, the controller is configured to perform a functional assessment of the pelvic floor muscles by the following steps to obtain the assessment results: Based on the electromyographic signals acquired through electrodes in the acquisition state, the electromyographic signal intensity index of each acquisition channel and the synergy index between signals of different channels are calculated. Evaluation results are generated based on electromyographic signal intensity and synergy indicators.

[0093] Specifically, the first step of the controller's assessment of pelvic floor muscle function is implemented as follows: The controller acquires multi-channel electromyographic (EMG) signals from all electrodes in the acquisition state. For each acquisition channel, the controller processes the continuous EMG signal data stream within a predefined standardized assessment cycle, such as a complete "contraction-hold-relaxation" command cycle. The controller calculates the root mean square (RMS) of the signal values ​​within a sliding time window to obtain an EMG signal intensity index characterizing the muscle contraction intensity of that region. Simultaneously, to assess the coordination ability between different muscle regions, the controller selects two different acquisition channels and calculates the correlation coefficient between their signal segments within the same time window. This correlation coefficient serves as a synergy index characterizing the synergy of the corresponding muscle groups in these two channels. The controller performs this calculation for all channels to be assessed, thereby obtaining a set of synergy indices reflecting the overall pelvic floor muscle network's synergy. For example, in one assessment, the controller controls six electrodes in the acquisition state. While the patient performs a standard five-second contraction task, the controller records data from all channels. For channel three, corresponding to the "left levator ani muscle," the controller takes the three-second data point showing the most stable contraction and calculates its root mean square value of 25 microvolts, which is the electromyographic signal intensity index for this channel. Simultaneously, the controller selects signals from channel three and channel four, corresponding to the "right levator ani muscle," and calculates their correlation coefficient over these three seconds, obtaining a result of 0.65, which is the synergy index between these two channels.

[0094] The second step of the controller's functional assessment is implemented as follows: After calculating the electromyographic signal intensity indices and synergy indices for each channel, the controller enters a logical judgment stage to generate assessment results. The controller internally stores benchmark data for comparison, which may include the normal intensity threshold range from population statistics, the ideal synergy threshold, or a personal baseline established through the patient's historical data. The controller compares each currently calculated intensity index with its corresponding intensity threshold, determining whether it falls within the "normal," "low," or "high" range. Simultaneously, it compares key synergy indices with synergy thresholds, determining whether the corresponding muscle group pairs are "well-synergistic" or "dyssynergistic." Combining these binary judgment results, the controller generates a structured assessment result. This result not only includes the intensity levels of the muscles in each channel but, more importantly, reveals the functional status zoning of the pelvic floor muscles, such as identifying clinically significant conclusions like "left-sided weak area," "right-sided compensatory high-activity area," and "anterior and posterior muscle synergy dyssynergy." For example, continuing from the previous example, the controller compares the intensity value of channel three (25 microvolts) with the intensity threshold of 30 microvolts and determines it as "low"; simultaneously, it compares the synergy index of channel three and channel four (0.65 with the synergy threshold of 0.8) and determines it as "synergistic dysfunction". Combining the analysis of other channels, the final evaluation result generated by the controller may be described as: weak left levator ani muscle strength, and significantly insufficient synergy between left and right levator ani muscle contractions.

[0095] Furthermore, the electromyographic signal intensity index is the root mean square value of the signal, and the synergy index is the correlation coefficient or mutual information between channel signals.

[0096] The root mean square (RMS) value of a signal is a time-domain indicator characterizing the amplitude or energy intensity of an electromyographic (EMG) signal. The calculation process involves the controller first capturing a discrete sequence of EMG signals from a specific acquisition channel over a continuous time period. The value of each data point in this sequence is squared, and then the arithmetic mean of these squared values ​​is calculated. Finally, the square root of this mean is taken, and the result is the RMS value of that signal segment. Physiologically, the amplitude of the EMG signal increases during pelvic floor muscle contraction, and its RMS value rises accordingly. Therefore, this indicator directly reflects the intensity of electrical activity generated by the local muscles corresponding to a specific electrode during the assessment period, and is thus used to quantify the contractile force or activation level of the muscles in that area. A higher RMS value generally indicates a more powerful muscle contraction.

[0097] The correlation coefficient between channel signals is a statistical indicator that measures the degree of linear correlation or waveform similarity between electromyographic signals acquired from two different acquisition channels. The controller selects signal sequences from two channels within the same time window for calculation. The correlation coefficient ranges between negative and positive one. When the value is close to positive one, it indicates that the waveform changes of the two channels are highly synchronized, with one rising while the other rises, and one falling while the other falls, meaning that the muscle regions corresponding to these two channels have good coordination in contraction timing and pattern, and may have functional synergy. When the value is close to zero, it indicates that there is no obvious linear correlation between the signal changes of the two, and poor synergy. When the value is close to negative one, it indicates that the change trends of the two are opposite, and may have functional antagonism. By calculating the correlation coefficient between all relevant channel pairs, the controller can construct a synergistic network model of the pelvic floor muscle group.

[0098] Mutual information between channel signals is a metric used to measure the statistical dependence between two signals, capturing broader dependency patterns, including nonlinear relationships. Mutual information calculates the extent to which the uncertainty about the signal of one channel can be reduced when the signal of another channel is known. If the signals of two channels are independent, the mutual information is zero; if they have any form of statistical dependence (linear or nonlinear), the mutual information is positive, with a larger positive value for stronger dependence. In this application, mutual information is used to assess the strength of correlations in signal transduction or covariation patterns of electrical activity in different muscle regions, even if their waveforms do not show significant linear correlations; mutual information may still reveal underlying synergistic or co-activation mechanisms.

[0099] In one possible embodiment, the controller is also configured to: If the electromyographic signal intensity index is lower than the first threshold in a preset first number of channels, it is determined to be a global relaxation-type injury. If the electromyographic signal intensity index is significantly lower than that of the adjacent channels in the preset second number of channels, it is determined to be a localized weak lesion. If the difference in electromyographic signal intensity or synergy index between the symmetrically arranged left and right channels exceeds the second threshold, it is determined to be a unilateral injury. If the overall level of the synergy index is below the third threshold, it is determined to be a synergy disorder type of injury.

[0100] Specifically, for determining overall relaxation-type lesions, after calculating the electromyographic signal intensity indicators of all acquisition channels, the controller compares these indicators one by one with a preset first threshold. The first threshold is an empirical value representing the minimum electrical activity intensity required for normal muscle contraction. The controller counts the number of channels with intensity indicators below this first threshold and compares this number with a preset first quantity value. This first quantity value is usually set as a large proportion of the total number of acquisition channels, for example, exceeding 70%. If the number of weak signal channels obtained reaches or exceeds this first quantity, and these channels are widely distributed in the electrode layout scheme and not concentrated in a single area, the controller determines that the pelvic floor muscles exhibit widespread functional decline, i.e., overall relaxation-type lesions. For example, suppose the system uses eight acquisition channels, the preset first quantity is six, and the first threshold is 25 microvolts. The controller calculates and finds that seven channels have a root mean square value below 25 microvolts, and these channels correspond to multiple zones in the front, back, left, and right. Since the number of weak signal channels seven is greater than the preset number six and is widely distributed, the controller determines it to be an overall relaxation-type lesion.

[0101] To determine the presence of localized weak points, the controller analyzes intensity indices not only by their absolute values ​​but also by their relative spatial differences. Based on the electrode layout, the controller defines one or more spatially or functionally adjacent channels as "neighboring channels" for each channel. The controller calculates the difference or ratio between the intensity index of this channel and the average intensity index of all its neighboring channels. If this difference or ratio exceeds a preset significant difference threshold, and the number of channels significantly weaker than their neighbors reaches a preset second number (typically small, such as one or two), the controller determines that a localized weak point exists. For example, suppose electrode five corresponds to a specific muscle point, and its neighboring channels are electrodes four and six. The intensity index of electrode five is 20 microvolts, while the average intensity of its neighboring channels, electrodes four and six, is 40 microvolts. The difference is 20 microvolts, far exceeding the preset 15 microvolt difference threshold. Furthermore, this is the only location in the system with such a significant local difference. Based on this, the controller determines it to be a localized weak point.

[0102] To determine lateral damage, the controller relies on predefined left and right symmetrical channel pairs in the electrode layout. For each symmetrical left and right channel pair, the controller calculates the absolute value or ratio of the difference in their intensity indices, and also calculates the difference in their synergy indices (e.g., the correlation coefficient between the two channels). The controller compares these differences to a preset second threshold. If a certain number of symmetrical channel pairs (e.g., more than half) have intensity or synergy differences exceeding the second threshold, the controller determines that lateral damage exists. For example, define left channels L1, L2 and right channels R1, R2 as two symmetrical channels. The controller calculates that the intensity ratio of L1 to R1 is 0.5 (the left side is only half that of the right side), the intensity ratio of L2 to R2 is 0.6, and the synergy indices of the two channels also show that the synergy within the left side is much lower than that of the right side. The preset second threshold stipulates that an intensity ratio below 0.7 or a synergy difference greater than 0.3 indicates significant lateralization. The current data meets the conditions, and the controller determines it to be lateral damage.

[0103] To determine synergistic dysfunction, the controller calculates the synergy indices between all relevant channel pairs and then performs an overall statistical analysis of these indices, such as calculating the mean or median of all indices. The controller compares this statistical value to a preset third threshold. This third threshold represents the minimum level of synergy required to maintain normal pelvic floor muscle function. If the calculated overall synergy level is lower than this third threshold, the controller determines that the overall coordination ability between muscle groups is insufficient, constituting synergistic dysfunction. For example, the controller calculates the correlation coefficients between fifteen channel pairs, with an average value of 0.45. The preset third threshold is 0.6. Since the average value of 0.45 is lower than the threshold of 0.6, the controller determines it to be synergistic dysfunction.

[0104] In practice, the determination of the first quantity, second quantity, first threshold, second threshold, and third threshold is typically based on a combination of clinical big data statistical analysis, expert consensus, and experimental verification. These values ​​can be calibrated by physicians during system initialization according to population characteristics. The first quantity is usually set to 60% to 80% of the total number of acquisition channels; for example, a typical value in an 8-channel system is 5 or 6. The second quantity is usually set to 1 to 2 to identify focal defects. The typical range for the first threshold (intensity threshold) is 20 microvolts to 40 microvolts, depending on the amplifier gain and normalization scheme. The second threshold (lateral difference threshold) is usually set when the intensity ratio between symmetrical channels is less than 0.7 to 0.8, or the absolute value of the synergy difference is greater than 0.2 to 0.3. The typical range for the third threshold (overall synergy threshold) is when the average correlation coefficient is between 0.5 and 0.7. All thresholds can be individually adjusted according to specific assessment protocols and patient population baseline data.

[0105] In one possible embodiment, the controller is also configured to: Based on the muscle strength map, weak areas of function were identified; When determining the electrode configuration scheme, electrodes covering functionally weak areas are configured as stimulation electrodes.

[0106] Specifically, the controller retrieves pre-generated muscle strength map data, which represents the electromyographic (EMG) signal intensity values ​​corresponding to various locations of the pelvic floor muscles in the form of a two-dimensional matrix or image. The controller compares the intensity value of each location (or pixel) in the map with a preset functional threshold. This functional threshold represents the minimum level of EMG activity required to maintain normal pelvic floor support function. The controller marks all continuous spatial regions with intensity values ​​consistently and significantly lower than this functional threshold as functionally weak areas. The identification process considers not only the intensity of individual points but also the continuity and area of ​​the region to avoid misclassifying isolated noise points as weak areas. For example, the muscle strength map shows a continuous region in the area corresponding to the "middle segment of the levator ani muscle" where the color depth (representing intensity value) is significantly lighter than the surrounding area, and the calculated intensity values ​​of all points in this region are lower than the preset 30 microvolt threshold. The controller identifies this continuous low-intensity region through image processing or matrix analysis and marks its boundary coordinates as functionally weak areas.

[0107] After identifying the weak functional area, the controller enters the electrode configuration decision-making phase. The controller accesses a pre-stored electrode layout scheme, which defines the mapping relationship between each physical electrode and its spatial coordinates on the muscle strength map. The controller compares the coordinate range of the identified weak functional area with the coordinates of all electrodes. Electrodes whose coordinates fall within the boundary of the weak functional area, or whose coordinates are closest to the centroid of the weak functional area and can effectively cover it, are selected by the controller as targets to be activated. In the final generated electrode configuration scheme, the controller explicitly includes these selected electrodes in the second electrode subset, defining them as stimulation electrodes. The controller ensures that these electrodes are used to output electrical stimulation signals in subsequent treatment phases. For example, the controller identifies a weak functional area located within a rectangle between coordinates (X1, Y1) and (X2, Y2). The electrode layout scheme indicates that the coordinates of electrodes four, five, and six are located within this rectangle. Therefore, when determining the electrode configuration scheme, the controller includes electrodes four, five, and six in the second electrode subset, designating them as stimulation electrodes for the current treatment cycle.

[0108] In this way, by automating and precisely mapping and logically associating abstract muscle strength map data with specific electrode locations, this system achieves a seamless transition from "assessing and identifying weaknesses" to "instructing which electrode to use for treatment." This mechanism ensures that electrical stimulation energy can be directed most efficiently and directly to the functionally deficient areas confirmed by objective assessment, achieving true spatial targeted therapy. It avoids wasting stimulation energy and overstimulating non-target areas, thereby significantly improving the accuracy, safety, and personalization of rehabilitation treatment.

[0109] In one possible embodiment, the controller is configured to determine the electrode layout scheme by at least one of the following methods: Load the pre-stored standard layout template as the electrode layout scheme; The display unit guides users to perform specific pelvic floor muscle contraction movements, and establishes an electrode layout scheme that represents the correspondence between electrodes and anatomical locations based on the characteristics of the collected electromyographic signal response. By measuring the bioimpedance characteristics between electrodes, the generated impedance characteristics are compared with a pre-stored tissue impedance model to obtain an electrode layout scheme representing the contact position of each electrode.

[0110] Specifically, the first method by which the controller determines the electrode layout scheme is implemented as follows: The controller retrieves multiple pre-stored standard layout templates from its non-volatile memory. These templates are pre-established based on the correspondence between the physical dimensions of different types of electrode arrays (such as a six-electrode ring array or an eight-electrode strip array) and the conventional pelvic floor anatomical locations. The controller automatically selects a matching standard template based on the electrode array model detected by the system or input by the user, and loads it as the currently used electrode layout scheme. This scheme is a data file that explicitly lists the identifier (such as a number) of each electrode and its assumed corresponding anatomical location name or coordinates. For example, when the system detects that an "Eight-Electrode Ring Array of Type A" is connected, the controller automatically loads the corresponding "Ring Eight-Point Standard Template." This template defines electrodes one and two as corresponding to the vestibular muscle area, electrodes three and four as corresponding to the left levator ani muscle area, electrodes five and six as corresponding to the right levator ani muscle area, and electrodes seven and eight as corresponding to the perineal central tendon area. This template is then used as the electrode layout scheme.

[0111] The second method for determining the electrode layout scheme by the controller is implemented as follows: The controller provides text and animation guidance to the user through the display unit, guiding them to sequentially perform specific contraction actions that can isolate and activate different pelvic floor muscle regions, such as "contract only the anal sphincter" or "attempt to interrupt urine flow." While the user performs each specified action, the controller simultaneously collects electromyographic (EMG) signals from all electrodes. The controller analyzes which electrode channels exhibit the most significant amplitude increase and specific activation patterns during the specific action. By comparing the response characteristics of each channel under different actions, the controller can infer the anatomical functional area most likely covered by each electrode. For example, when performing the "interrupt urine flow" action, if only electrodes one and two show a strong response while other electrodes remain calm, the controller can infer that electrodes one and two are located in the area related to the urethral sphincter (vestibular muscle). Based on the analysis of the response patterns of all guided actions, the controller automatically generates a mapping table describing the correspondence between electrode labels and inferred anatomical locations, which serves as the electrode layout scheme.

[0112] The third method for the controller to determine the electrode layout scheme is implemented as follows: The controller controls the electrical stimulation circuit to output a safe, low-amplitude AC test current between any two electrodes, and measures the bioimpedance value between these two electrodes through the signal acquisition circuit, including the amplitude and phase information of the impedance. The controller iterates through and measures the bioimpedance between all electrode pairs, forming impedance network data. The controller compares the measured impedance characteristics (such as the impedance value of a specific electrode pair and the impedance gradient between adjacent electrode pairs) with the pelvic floor tissue impedance model pre-stored in memory. This model describes the typical impedance characteristics corresponding to different tissues (such as vaginal mucosa, rectal wall, and muscle tissue) and their spatial relationships. Through a pattern matching algorithm, the controller infers the main tissue type currently contacted by each electrode and its relative spatial relationship, thereby calculating the estimated position of each electrode in the pelvic floor cavity and generating an electrode layout scheme accordingly. For example, the controller measurements revealed that the impedance between electrodes A and B was very low and capacitive, matching the pre-stored model's characteristic that "electrodes are both in contact with the vaginal mucosa and close to each other"; while the impedance between electrodes A and F was high and resistive, matching the model's characteristic that "electrodes are located on the anterior vaginal wall and the posterior rectal wall, respectively". By combining the measurement results of all electrode pairs, the controller can construct a spatial distribution map of each electrode and use it as a layout scheme.

[0113] Thus, by providing three complementary methods for determining electrode placement—loading templates, user-guided mapping, and bioimpedance localization—this system greatly enhances its flexibility, adaptability, and accuracy in practical clinical applications. Whether using standardized electrodes or dealing with complex situations such as individual anatomical differences and electrode placement deviations, one or more of these methods can be combined to reliably establish the correspondence between electrodes and the anatomical functional areas of the pelvic floor muscles. This lays a precise spatial information foundation for all subsequent zonal assessments, targeted stimulation, and visualization, thereby ensuring the personalization and precision of the entire rehabilitation treatment process.

[0114] Please see Figure 8 , Figure 8 This is a flowchart illustrating an embodiment of the electrode control method provided in this application. This embodiment primarily uses the application of this electrode control method to the aforementioned pelvic floor muscle repair device as an example. Specifically, the electrode control method provided in an embodiment of this application may include the following steps: S1. Determine the electrode configuration scheme based on the electromyographic signals obtained by the signal acquisition circuit and the electrode layout scheme.

[0115] The electrode configuration scheme is used to define a first subset of electrodes in the acquisition electrode state and a second subset of electrodes in the stimulation electrode state.

[0116] S2. Control the switching state of each switching unit in the switch array according to the electrode configuration scheme.

[0117] The specific process of the controller executing step S1 is as follows: First, it acquires multi-channel electromyographic (EMG) signals from the signal acquisition circuit and calls the electrode layout scheme pre-stored in its memory. The electrode layout scheme defines the mapping relationship between each physical electrode and the anatomical regions of the pelvic floor muscles. The controller analyzes the acquired EMG signals, including calculating the temporal intensity index (such as root mean square value) of each effective channel signal and analyzing the synergy index (such as correlation coefficient) between different channel signals. The controller compares these analysis results with preset physiological thresholds to identify functionally weak areas, synergistically dysfunctional areas, and functionally normal areas in the pelvic floor muscle group. Based on this identification result and combined with the spatial location information provided by the electrode layout scheme, the controller generates a clear electrode configuration scheme through internal decision logic. This scheme specifically defines two electrode subsets: the first electrode subset specifies the electrodes used for continuous or extended monitoring of EMG activity in subsequent steps, which usually need to cover key assessment areas; the second electrode subset specifies the electrodes used to apply targeted electrical stimulation, and its selection directly corresponds to the identified specific muscle group areas that need intervention. The first and second subsets may overlap or be completely separate depending on the assessment strategy.

[0118] The specific process of the controller executing step S2 is as follows: After the electrode configuration scheme is generated, its internal multi-channel timing scheduling module converts the scheme into control instructions that directly drive each switching unit in the switch array. These instructions correspond one-to-one with the switching unit, and their logical state directly determines whether the corresponding electrode will be switched to the acquisition electrode state, the stimulation electrode state, or the floating state. The output of these control instructions strictly follows a precise timing schedule managed by the controller. This timing divides the system's working cycle into different stages, such as consecutive signal acquisition windows and electrical stimulation windows. Within the signal acquisition window, the controller outputs instructions to connect all electrodes in the first electrode subset to the signal acquisition circuit. In the immediately following electrical stimulation window, the controller outputs another set of instructions to connect the electrodes in the second electrode subset to the electrical stimulation circuit, and usually switches electrodes used only for acquisition to the floating state. The timing of the entire switching process is guaranteed by the controller's hardware timer, ensuring the accuracy of the actions and the synchronization between channels.

[0119] In one possible embodiment, determining the electrode configuration scheme based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme includes: Determine the electrode layout scheme, which is used to indicate the placement position of each electrode in the electrode array; Based on the electromyographic signals acquired through the signal acquisition circuit, the pelvic floor muscles are functionally assessed to obtain the assessment results. Based on the evaluation results and the electrode layout scheme, an electrode configuration scheme is determined.

[0120] In one possible embodiment, the method further includes: When the switch array is controlled to switch any one of the electrodes between the stimulation electrode state and the acquisition electrode state, a protection time window of a preset duration is inserted. During the protection time window, the electrode is controlled to switch to a suspended state.

[0121] In one possible embodiment, the method further includes: The electrical stimulation circuit is controlled to output electrical stimulation signals through the electrodes in the stimulation electrode state in at least one of the following modes: The rotation mode activates different stimulation electrodes or groups of stimulation electrodes in turn. Cross mode, which alternately activates two stimulating electrodes or groups of stimulating electrodes corresponding to synergistic or antagonistic muscle groups; Synchronization mode: Simultaneously activates multiple or all of the stimulation electrodes.

[0122] In one possible embodiment, the step of performing a functional assessment of the pelvic floor muscles based on the electromyographic signals acquired through the signal acquisition circuit to obtain the assessment result includes: Based on the electromyographic signals acquired through electrodes in the acquisition state, the electromyographic signal intensity index of each acquisition channel and the synergy index between signals of different channels are calculated. An evaluation result is generated based on the electromyographic signal intensity index and the synergy index.

[0123] In one possible embodiment, the method further includes: If the electromyographic signal intensity index is lower than a first threshold in a preset first number of channels, it is determined to be a global relaxation-type injury. If the electromyographic signal intensity index is significantly lower than that of the adjacent channels in a preset second number of channels, it is determined to be a localized weak injury. If the difference in electromyographic signal intensity or synergy index between the symmetrically arranged left and right channels exceeds the second threshold, it is determined to be a unilateral injury. If the overall level of the synergy index is lower than the third threshold, it is determined to be a synergy disorder type of injury.

[0124] In one possible embodiment, the evaluation results include: muscle strength map; The muscle strength map is generated through the following steps: Map the anatomical location corresponding to each acquisition channel to a preset pelvic floor muscle group spatial diagram; The electromyographic signal intensity indicators of each acquisition channel are visualized and rendered in a color-coded manner at the corresponding positions in the spatial diagram to generate a two-dimensional muscle strength map.

[0125] In one possible embodiment, the method further includes: Based on the muscle strength map, weak functional areas were identified; When determining the electrode configuration scheme, the electrode covering the functionally weak area is configured as the stimulation electrode.

[0126] In one possible embodiment, the electrode layout scheme is determined by at least one of the following methods: Load the pre-stored standard layout template as the electrode layout scheme; The display unit guides users to perform specific pelvic floor muscle contraction movements, and establishes an electrode layout scheme that represents the correspondence between electrodes and anatomical locations based on the characteristics of the collected electromyographic signal response. By measuring the bioimpedance characteristics between electrodes and comparing the generated impedance characteristics with a pre-stored tissue impedance model, an electrode layout scheme representing the contact position of each electrode is obtained.

[0127] It should be understood that the specific implementation process and technical principles of each step in the above method embodiments are described in the above pelvic floor muscle repair device embodiments, and will not be repeated here.

[0128] Although Figure 8 The steps in the flowchart are shown sequentially as indicated by the arrows, but these steps are not necessarily executed in the order indicated by the arrows. Unless otherwise specified in this document, there is no strict order in which these steps are executed, and they can be performed in other orders. Figure 4 At least some of the steps in the process may include multiple sub-steps or multiple stages. These sub-steps or stages are not necessarily completed at the same time, but can be executed at different times. The execution order of these sub-steps or stages is not necessarily sequential, but can be executed in turn or alternately with other steps or at least some of the sub-steps or stages of other steps.

[0129] To facilitate better implementation of the electrode control method of this application, this application also provides an electrode control device based on the above-described electrode control method. The meanings of the terms used are the same as in the electrode control method described above, and specific implementation details can be found in the descriptions within the method embodiments.

[0130] Please see Figure 9 , Figure 9 This is a schematic diagram of the structure of the electrode control device provided in the embodiments of this application. The electrode control device may specifically include: The determining module 201 is used to determine an electrode configuration scheme based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme; wherein, the electrode configuration scheme is used to define a first subset of electrodes in the acquisition electrode state and a second subset of electrodes in the stimulation electrode state; The control module 202 is used to control the switching state of each switching unit in the switch array according to the electrode configuration scheme.

[0131] For specific limitations regarding the electrode control device, please refer to the limitations of the electrode control method above, which will not be repeated here. Each module in the aforementioned electrode control device can be implemented entirely or partially through software, hardware, or a combination thereof. These modules can be embedded in hardware or independently of the processor in a computer device, or stored in software in the memory of a computer device, so that the processor can call and execute the operations corresponding to each module.

[0132] The specific implementation process and technical effects of the electrode control device provided in this embodiment can be referred to the above method embodiment, and the steps are repeated here.

[0133] Furthermore, embodiments of this application also provide an electronic device, such as... Figure 10As shown, it illustrates a structural schematic diagram of the electronic device involved in the embodiments of this application, specifically: The electronic device may include components such as a processor 301 with one or more processing cores, a memory 302 with one or more computer-readable storage media, a power supply 303, and an input unit 304. Those skilled in the art will understand that... Figure 10 The electronic device structure shown does not constitute a limitation on the electronic device and may include more or fewer components than shown, or combine certain components, or have different component arrangements. Wherein: The processor 301 is the control center of the electronic device. It connects various parts of the electronic device via various interfaces and lines, and performs various functions and processes data by running or executing software programs and / or modules stored in the memory 302, and by calling data stored in the memory 302, thereby providing overall monitoring of the electronic device. Optionally, the processor 301 may include one or more processing cores; preferably, the processor 301 may integrate an application processor and a modem processor, wherein the application processor mainly handles the operating system, user interface, and applications, and the modem processor mainly handles wireless communication. It is understood that the modem processor may not be integrated into the processor 301.

[0134] The memory 302 can be used to store software programs and modules. The processor 301 executes various functional applications and electrode control methods by running the software programs and modules stored in the memory 302. The memory 302 may mainly include a program storage area and a data storage area. The program storage area may store the operating system, application programs required for at least one function (such as sound playback function, image playback function, etc.), etc.; the data storage area may store data created according to the use of the electronic device, etc. In addition, the memory 302 may include high-speed random access memory, and may also include non-volatile memory, such as at least one disk storage device, flash memory device, or other volatile solid-state storage device. Accordingly, the memory 302 may also include a memory controller to provide the processor 301 with access to the memory 302.

[0135] The electronic device also includes a power supply 303 that supplies power to various components. Preferably, the power supply 303 can be logically connected to the processor 301 through a power management system, thereby enabling functions such as charging, discharging, and power consumption management through the power management system. The power supply 303 may also include one or more DC or AC power supplies, recharging systems, power fault detection circuits, power converters or inverters, power status indicators, and other arbitrary components.

[0136] The electronic device may also include an input unit 304, which can be used to receive input digital or character information and generate keyboard, mouse, joystick, optical or trackball signal inputs related to user settings and function control.

[0137] Although not shown, the electronic device may also include a display unit, etc., which will not be described in detail here. Specifically, in this embodiment, the processor 301 in the electronic device loads the executable files corresponding to the processes of one or more application programs into the memory 302 according to the following instructions, and the processor 301 runs the application programs stored in the memory 302, thereby realizing the steps in the electrode control method described above.

[0138] For details on the implementation of each of the above operations, please refer to the previous examples, which will not be repeated here.

[0139] Those skilled in the art will understand that all or part of the steps in the various methods of the above embodiments can be performed by instructions, or by instructions controlling related hardware. These instructions can be stored in a computer-readable storage medium and loaded and executed by a processor.

[0140] Therefore, embodiments of this application provide a storage medium storing a plurality of instructions that can be loaded by a processor to execute steps in any of the electrode control methods provided in embodiments of this application. For example, the instructions can execute steps in the aforementioned electrode control method.

[0141] For details on the implementation of each of the above operations, please refer to the previous examples, which will not be repeated here.

[0142] The storage medium may include: read-only memory (ROM), random access memory (RAM), disk or optical disk, etc.

[0143] Since the instructions stored in the storage medium can execute the steps of any of the electrode control methods provided in the embodiments of this application, the beneficial effects that any of the electrode control methods provided in the embodiments of this application can achieve can be realized, as detailed in the preceding embodiments, and will not be repeated here.

[0144] The above provides a detailed description of the pelvic floor muscle repair device, electrode control method, apparatus, equipment, and medium provided in the embodiments of this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the methods and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A pelvic floor muscle repair device, characterized in that, include: The main body is used for insertion or placement into the corresponding part of the pelvic floor muscles, and the main body is provided with an electrode array including at least two electrodes; An electrical stimulation circuit for generating at least one electrical stimulation signal; Signal acquisition circuit, used to acquire electromyographic signals; A switch array is connected to the electrode array, the electrical stimulation circuit, and the signal acquisition circuit. as well as The controller is connected to the electrical stimulation circuit, the signal acquisition circuit, and the switch array, respectively. The switch array is used, under the control of the controller, to switch the corresponding electrode to the electrostimulation circuit so that the electrode is switched to the stimulation electrode state, or to switch it to the signal acquisition circuit so that the electrode is switched to the acquisition electrode state, or to disconnect it from both the electrostimulation circuit and the signal acquisition circuit and be in a floating state. The controller is configured as follows: An electrode configuration scheme is determined based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme; wherein, the electrode configuration scheme is used to define a first subset of electrodes in the acquisition electrode state and a second subset of electrodes in the stimulation electrode state; The switching state of the switch array is controlled according to the electrode configuration scheme.

2. The pelvic floor muscle repair device according to claim 1, characterized in that, The switch array includes at least two switch units, each switch unit being connected to one electrode in the electrode array.

3. The pelvic floor muscle repair device according to claim 1, characterized in that, The electrical stimulation circuit includes one electrical stimulation unit or at least two electrical stimulation units, each electrical stimulation unit corresponds to a stimulation channel, and each stimulation channel outputs an electrical stimulation signal. When the electrical stimulation circuit includes an electrical stimulation unit, the electrical stimulation unit is connected to all the switching units in the switch array; When the electrical stimulation circuit includes at least two electrical stimulation units, each electrical stimulation unit is connected to at least one switching unit in the switch array.

4. The pelvic floor muscle repair device according to claim 1, characterized in that, The controller is also configured to: When the switch array is controlled to switch any one of the electrodes between the stimulation electrode state and the acquisition electrode state, a protection time window of a preset duration is inserted. During the protection time window, the electrode is controlled to switch to a suspended state.

5. The pelvic floor muscle repair device according to claim 3, characterized in that, The preset duration is 50 milliseconds to 100 milliseconds.

6. The pelvic floor muscle repair device according to claim 1, characterized in that, The signal acquisition circuit includes at least two independent signal acquisition units; each signal acquisition unit corresponds to an electrode and a stimulation channel, and each acquisition channel includes a preamplifier, a bandpass filter, and an analog-to-digital converter connected in sequence; the input terminal of the preamplifier is connected to the corresponding electrode through the switch array, and its common-mode rejection ratio is greater than 100dB; the passband frequency range of the bandpass filter is 20Hz to 450Hz; the output terminal of the analog-to-digital converter is connected to the controller. The controller is further configured as follows: The electromyographic signals from the bandpass filter are denoised using template matching or subtraction.

7. The pelvic floor muscle repair device according to claim 1 or 5, characterized in that, Each switch unit in the switch array includes: a first switch terminal, a second switch terminal, a third switch terminal, a common terminal, and a control terminal; The first switch terminal is connected to the output terminal of the corresponding electrical stimulation circuit, the second switch terminal is connected to the input terminal of the acquisition channel in the signal acquisition circuit, the common terminal is connected to the corresponding electrode, the control terminal is connected to the controller, and the third switch terminal is grounded or in a high-impedance state. When the common terminal is connected to the first switch terminal, the corresponding electrode is in the stimulation electrode state; when the common terminal is connected to the second switch terminal, the corresponding electrode is in the acquisition electrode state; when the common terminal is connected to the third switch terminal, the corresponding electrode is in the floating state.

8. The pelvic floor muscle repair device according to claim 1, characterized in that, The pelvic floor muscle repair device also includes a display unit, which is connected to the controller. The controller is also configured to display a visualization interface of the electrode layout scheme on the display unit.

9. The pelvic floor muscle repair device according to claim 1, characterized in that, The controller is also configured to: perform a functional assessment of the pelvic floor muscles based on the electromyographic signals acquired by the signal acquisition circuit to obtain an assessment result, and configure the stimulation parameters of each electrode in the second electrode subset based on the assessment result; The stimulation parameters include: waveform type, stimulation intensity, pulse frequency, and pulse width; wherein the adjustable range of the stimulation intensity is 0 to 50 mA, the adjustable range of the pulse frequency is 1 to 100 Hz, and the adjustable range of the pulse width is 50 to 500 μs.

10. The pelvic floor muscle repair device according to claim 1, characterized in that, The controller is further configured to control the electrical stimulation circuit to output an electrical stimulation signal through the electrodes in the stimulation electrode state in at least one of the following modes: The rotation mode activates different stimulation electrodes or groups of stimulation electrodes in turn. Cross mode, which alternately activates two stimulating electrodes or groups of stimulating electrodes corresponding to synergistic or antagonistic muscle groups; Synchronization mode: Simultaneously activates multiple or all of the stimulation electrodes.

11. The pelvic floor muscle repair device according to claim 1, characterized in that, The controller is configured to perform a functional assessment of the pelvic floor muscles and obtain assessment results by performing the following steps: Based on the electromyographic signals acquired through electrodes in the acquisition state, the electromyographic signal intensity index of each acquisition channel and the synergy index between signals of different channels are calculated. An evaluation result is generated based on the electromyographic signal intensity index and the synergy index.

12. The pelvic floor muscle repair device according to claim 11, characterized in that, The electromyographic signal intensity index is the root mean square value of the signal, and the synergy index is the correlation coefficient or mutual information between channel signals.

13. The pelvic floor muscle repair device according to claim 11, characterized in that, The controller is also configured to: If the electromyographic signal intensity index is lower than a first threshold in a preset first number of channels, it is determined to be a global relaxation-type injury. If the electromyographic signal intensity index is significantly lower than that of the adjacent channels in a preset second number of channels, it is determined to be a localized weak injury. If the difference in electromyographic signal intensity or synergy index between the symmetrically arranged left and right channels exceeds the second threshold, it is determined to be a unilateral injury. If the overall level of the synergy index is lower than the third threshold, it is determined to be a synergy disorder type of injury.

14. The pelvic floor muscle repair device according to claim 11, characterized in that, The assessment results include: muscle strength maps; The controller is configured to generate the muscle strength map through the following steps: Map the anatomical location corresponding to each acquisition channel to a preset pelvic floor muscle group spatial diagram; The electromyographic signal intensity indicators of each acquisition channel are visualized and rendered in a color-coded manner at the corresponding positions in the spatial diagram of the pelvic floor muscles to generate a two-dimensional muscle strength map.

15. The pelvic floor muscle repair device according to claim 14, characterized in that, The controller is also configured to: Based on the muscle strength map, weak functional areas were identified; When determining the electrode configuration scheme, the electrode covering the functionally weak area is configured as the stimulation electrode.

16. The pelvic floor muscle repair device according to claim 1, characterized in that, The controller is configured to determine the electrode layout scheme in at least one of the following ways: Load the pre-stored standard layout template as the electrode layout scheme; The display unit guides users to perform specific pelvic floor muscle contraction movements, and establishes an electrode layout scheme that represents the correspondence between electrodes and anatomical locations based on the characteristics of the collected electromyographic signal response. By measuring the bioimpedance characteristics between electrodes and comparing the generated impedance characteristics with a pre-stored tissue impedance model, an electrode layout scheme representing the contact position of each electrode is obtained.

17. An electrode control method, characterized in that, The method is applied to the pelvic floor muscle repair device as described in any one of claims 1 to 16; the method includes: The electrode configuration scheme is determined based on the electromyographic signals acquired by the signal acquisition circuit and the electrode layout scheme; wherein, the electrode configuration scheme is used to define a first subset of electrodes in the acquisition electrode state and a second subset of electrodes in the stimulation electrode state; According to the electrode configuration scheme, the switching state of each switching unit in the switch array is controlled.

18. An electronic device, characterized in that, include: A memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor, when executing the computer program, implements the steps of the electrode control method as claimed in claim 17.

19. A storage medium, characterized in that, It stores a computer program that can be loaded by a processor and executed as described in claim 17.

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