Electrical stimulation system

Abstract

Provided in the embodiments of the present application is an electrical stimulation system. The electrical stimulation system comprises: a control module, a detection module and an electrical stimulation module, wherein the electrical stimulation module comprises a stimulation electrode pad, the surface of which is provided with a plurality of electrode points; the control module is used for determining a plurality of electrode matrices on the basis of the plurality of electrode points; the control module is further used for performing electrical stimulation on a stimulation point using each of the plurality of electrode matrices; the detection module is used for collecting an electrophysiological response corresponding to each of the plurality of electrode matrices; the control module is further used for determining an optimal electrode matrix from among the plurality of electrode matrices on the basis of the electrophysiological responses; and the control module is further used for performing electrical stimulation on the stimulation point using the optimal electrode matrix.

Description

An electrical stimulation system

[0001] Cross-reference to Related Applications

[0002] This application is based on and claims priority to Chinese Patent Application No. 202410789498.8, filed on June 18, 2024, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application belongs to the technical field of medical treatment, and specifically relates to an electrical stimulation system. BACKGROUND

[0004] The current use scene of the electrical stimulator is usually that a professional person guides the position of electrical stimulation, and electrode patches are placed at the determined electrical stimulation position. However, due to the different professional knowledge and work experience of different people, the determined electrical stimulation position will be different, and at the same time, due to the individual differences of patients, the best electrical stimulation position will also be deviated, which will lead to poor treatment effect.

[0005] SUMMARY

[0006] The present application provides an electrical stimulation method, an electrical stimulation system, an electronic device, a chip, a computer readable storage medium and a computer program product.

[0007] The electrical stimulation method provided by the present application is applied to an electrical stimulation system, the electrical stimulation system comprises: a stimulation electrode patch; a plurality of electrode points are arranged on the surface of the stimulation electrode patch; and the method comprises the following steps.

[0008] A plurality of electrode matrices are determined according to the plurality of electrode points;

[0009] Each electrode matrix in the plurality of electrode matrices is used to perform electrical stimulation on a stimulation point respectively, and an electro-physiological response corresponding to each electrode matrix in the plurality of electrode matrices is collected; the electro-physiological response is physiological reaction information caused by electrical stimulation when each electrode matrix in the plurality of electrode matrices is used to perform electrical stimulation on the stimulation point respectively;

[0010] An optimal electrode matrix is determined from the plurality of electrode matrices based on the electro-physiological response;

[0011] The optimal electrode matrix is used to perform electrical stimulation on the stimulation point.

[0012] The electrical stimulation system provided by the present application comprises a control module, a detection module and an electrical stimulation module; the electrical stimulation module comprises a stimulation electrode patch; and a plurality of electrode points are arranged on the surface of the stimulation electrode patch.

[0013] The control module is configured to determine a plurality of electrode matrices according to the plurality of electrode points.

[0014] The control module is further configured to respectively perform electrical stimulation on the stimulation points by using each of the plurality of electrode matrices.

[0015] The detection module is configured to collect an electrophysiological response corresponding to each of the plurality of electrode matrices; the electrophysiological response is physiological reaction information caused by electrical stimulation when each of the plurality of electrode matrices respectively performs electrical stimulation on the stimulation points.

[0016] The control module is further configured to determine an optimal electrode matrix from the plurality of electrode matrices based on the electrophysiological response.

[0017] The control module is further configured to perform electrical stimulation on the stimulation points by using the optimal electrode matrix.

[0018] The electronic device provided by the embodiment of the present application comprises a processor and a memory, the memory is used to store a computer program, the processor is configured to call and run the computer program stored in the memory, and execute any electrical stimulation method provided by the embodiment of the present application.

[0019] The chip provided by the embodiment of the present application comprises a processor configured to call and run a computer program from a memory, so that a device installed with the chip executes any electrical stimulation method provided by the embodiment of the present application.

[0020] The computer readable storage medium provided by the embodiment of the present application is configured to store a computer program, and the computer program causes a computer to execute any electrical stimulation method provided by the embodiment of the present application.

[0021] The computer program product provided by the embodiment of the present application comprises a computer program, and the computer program causes a processor to execute any electrical stimulation method provided by the embodiment of the present application.

[0022] Through the electrical stimulation system provided by the embodiment of the present application, the optimal electrode matrix can be determined, the position deviation of the stimulation electrode sheet can be corrected by the optimal electrode matrix if there is a position deviation, the position deviation caused by different experiences of doctors can be avoided, and different optimal electrode matrices can be matched for different patients to ensure the treatment effect of the patients. BRIEF DESCRIPTION OF DRAWINGS

[0023] The drawings described herein are used to provide further understanding of the present application, and form a part of the present application. The schematic embodiments of the present application and the descriptions thereof are used to explain the present application, and do not constitute an improper limitation on the present application. In the drawings:

[0024] FIG. 1 is a schematic diagram of an implementation process of an electrical stimulation method according to an embodiment of the present application;

[0025] FIG. 2 is a schematic diagram of a setting of electrode points of a stimulation electrode patch according to an embodiment of the present application;

[0026] FIG. 3 is a schematic diagram of a process of determining an optimal electrode matrix according to an embodiment of the present application;

[0027] FIG. 4 is a schematic diagram of a process of scoring an electromyography signal according to an embodiment of the present application;

[0028] FIG. 5 is a schematic diagram of an implementation process of an electrical stimulation method according to an embodiment of the present application;

[0029] FIG. 6 is a schematic diagram of a structure of an electrical stimulation system 600 according to an embodiment of the present application;

[0030] FIG. 7 is a schematic diagram of a structure of a stimulation circuit according to an embodiment of the present application;

[0031] FIG. 8 is a schematic diagram of a structure of a constant current module, an H-bridge circuit and an MCU according to an embodiment of the present application;

[0032] FIG. 9 is a schematic diagram of a structure of a boost module according to an embodiment of the present application;

[0033] FIG. 10 is a schematic diagram of a placement position of a stimulation electrode patch according to an embodiment of the present application;

[0034] FIG. 11a is a schematic diagram of wearing of an electrical stimulation system according to an embodiment of the present application;

[0035] FIG. 11b is a schematic diagram of wearing of an electrical stimulation system according to an embodiment of the present application;

[0036] FIG. 11c is a schematic diagram of wearing of an electrical stimulation system according to an embodiment of the present application;

[0037] FIG. 12 is a schematic diagram of a structure of an electrode patch according to an embodiment of the present application;

[0038] FIG. 13 is a schematic diagram of a structure of an electrical stimulation system 1300 according to an embodiment of the present application;

[0039] FIG. 14 is a schematic diagram of a structure of an electronic device according to an embodiment of the present application;

[0040] FIG. 15 is a schematic diagram of a structure of a chip according to an embodiment of the present application. DETAILED DESCRIPTION

[0041] With reference to the drawings, the technical solutions in the embodiments of the present application will be described below. Obviously, the described embodiments are only some, but not all, of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of the present application.

[0042] It should be noted that in the embodiments of the present application, the term "and / or" is only used to describe the association relationship of the associated objects, and can represent the three cases of existence of A alone, existence of A and B simultaneously, and existence of B alone. In addition, in the embodiments of the present application, the character " / " generally represents an "or" relationship between the front and rear associated objects.

[0043] In the description of the embodiments of the present application, the term "corresponding" can represent a direct or indirect corresponding relationship between the two, can also represent an associated relationship between the two, and can also indicate a relationship such as indicated and configured.

[0044] In order to facilitate the understanding of the technical solutions of the embodiments of the present application, the related technologies of the embodiments of the present application are described below. The following related technologies can be combined with the technical solutions of the embodiments of the present application in any way, and all belong to the protection scope of the embodiments of the present application.

[0045] Overactive Bladder Syndrome (OAB) is considered a functional bladder disorder in medicine. OAB can be manifested as detrusor overactivity in urodynamics, or other forms of urethra-bladder dysfunction. The pathogenesis of OAB is complex, and the urination process is controlled by high-level neural centers (such as cerebral cortex, brainstem, spinal cord) and peripheral nervous system (autonomic nerve, somatic nerve), and lower urinary tract sensory nerves also participate in urination regulation. Any abnormal function of the above parts can cause OAB, and different pathophysiological mechanisms can lead to similar symptoms. Although OAB usually has no obvious organic disease, its most important feature is urinary urgency, often accompanied by symptoms such as urinary frequency and nocturia; severe cases may even have urge incontinence, and OAB affects patients' social activities, travel, sleep quality, and greatly reduces patients' quality of life.

[0046] Neuromodulation therapy as a treatment method, which is characterized by the ability to treat patients who have no significant effect on bladder training and drug therapy. The specific implementation includes sacral neuromodulation (SNM): the treatment of bladder by regulating the nerve pathway through surgical implantation of an electrical stimulator to stimulate the sacral spinal nerve root; and tibial nerve stimulation (PTNS): stimulating the sacral nerve plexus through a needle-shaped electrode placed on the medial malleolus to treat, which is an indirect treatment and less effective than continuous treatment of SNM. Although SNM has the best effect, the surgical cost is high, accompanied by implantable surgery and a certain recovery period. The botulinum toxin injection scheme for the bladder wall requires regular treatment. The traditional PTNS neuromodulation therapy needs to be performed in a clinic or hospital, and the most common adverse reaction is usually pain at the puncture site (medial malleolus), local bleeding, and paresthesia. The non-home treatment and trauma of the treatment site make less than 1% of patients receive treatment.

[0047] Based on this background, the OAB treatment scheme that is non-drug, non-invasive, low side effect, and can be used at home can greatly help OAB patients.

[0048] A common percutaneous electrical stimulation single stimulation channel usually only includes one cathode and one anode, and the treatment effect may be deviated due to the effect of the paste and / or individual differences of the patient: deviation of the electrode patch placement position may cause the target nerve to not be stimulated or spread to the non-target area, thereby reducing the curative effect or causing side effects; deviation of the electrode position changes the distribution of the electric field, resulting in insufficient stimulation intensity received by the target area; deviation of the electrode position affects the consistency of the effect of each treatment. This consistency is reflected in the difference between people using the same therapy and the difference between multiple wearings of the same person.

[0049] FIG. 1 is a schematic diagram of the implementation process of the electrical stimulation method according to an embodiment of the present application. As shown in FIG. 1, the electrical stimulation method according to an embodiment of the present application is applied to an electrical stimulation system, which includes a stimulation electrode patch, and the surface of the stimulation electrode patch is provided with a plurality of electrode points. The method includes the following steps:

[0050] Step 101: determining a plurality of electrode matrices according to the plurality of electrode points.

[0051] In the embodiment of the present application, the surface of the stimulation electrode patch is provided with a plurality of electrode points. It can be understood that the stimulation electrode patch includes a positive stimulation electrode patch and a negative stimulation electrode patch, the surface of the positive stimulation electrode patch is provided with one or more electrode points, and the surface of the negative stimulation electrode patch is provided with one or more electrode points. The number of electrode points provided on the surface of the positive and negative stimulation electrode patches can be the same or different, and the present application does not limit this.

[0052] For example, referring to Figure 2, which is a schematic diagram of the electrode point setting of the stimulation electrode pad provided in the embodiment of this application, as shown in Figure 2, stimulation electrode 1 is a positive stimulation electrode pad, and the number of electrode points that can be set on its surface can be 3, 4 or 5; stimulation electrode 2 is a negative stimulation electrode pad, and the number of electrode points that can be set on its surface can be 3, 4 or 5. When different numbers of electrode points are set on the surface of the stimulation electrode pad, the setting position of each electrode point can be set with reference to Figure 2. For example, when the number of electrode points is 3, the positions of A1, A2, and A3 in the upper left figure of Figure 2 can be referenced; when the number of electrode points is 4, the positions of A1, A2, A3, and A4 in the upper figure of Figure 2 can be referenced; and when the number of electrode points is 5, the positions of A1, A2, A3, A4, and A5 in the upper right figure of Figure 2 can be referenced.

[0053] For example, in the embodiments of this application, if there are three electrode points A, B, and C in the positive stimulation electrode pad, and three electrode points D, E, and F in the positive stimulation electrode pad, the matrix that can be determined can be (A, D), (A, E), (A, F), (B, D), (B, E), (B, F), (C, D), (C, E), (C, F), a total of nine matrices. Of course, matrices such as (B, DE) and (A, DEF) can also be added. It is understood that the number of electrode matrices can be set according to actual needs, and this application does not limit it in this regard.

[0054] In this embodiment of the application, before determining multiple electrode matrices based on the multiple electrode points, the method further includes: detecting the impedance of each electrode point among the multiple electrode points, removing high-impedance and open-circuit electrodes, and then determining multiple electrode matrices.

[0055] Step 102: Apply electrical stimulation to the stimulation point using each of the multiple electrode matrices, and collect the electrophysiological response corresponding to each of the multiple electrode matrices; the electrophysiological response is the physiological response information caused by electrical stimulation when the stimulation point is electrically stimulated using each of the multiple electrode matrices.

[0056] In one optional embodiment of this application, the electrophysiological response includes one or more of the following information:

[0057] Information includes compound action potentials, electromyographic signals, local blood flow, muscle spatial displacement, and heart rate.

[0058] In this embodiment of the application, after determining multiple electrode matrices, each of the multiple electrode matrices is used to electrically stimulate the stimulation point with an electrical stimulation signal of first intensity. After the stimulation point is electrically stimulated, the nervous system and / or cardiovascular system and / or muscular system and / or circulatory system will have corresponding responses. The relevant response information of the nervous system and / or cardiovascular system and / or muscular system and / or circulatory system corresponding to the stimulation point is collected, such as electrically evoked compound action potential (ECAP) and / or electromyography (EMG) signals of nerves or muscles.

[0059] For example, electrical stimulation of the tibial nerve can induce contraction of the abductor hallucis muscle (AHM) on the sole of the foot.

[0060] Step 103: Based on the electrophysiological response, determine the optimal electrode matrix from the plurality of electrode matrices.

[0061] The electrophysiological responses of each collected electrode matrix are scored, and the optimal electrode matrix is ​​determined based on the scores of each electrode matrix.

[0062] Based on this, in an optional embodiment of this application, the step of applying electrical stimulation to the stimulation point using each of the plurality of electrode matrices, and collecting the electrophysiological response corresponding to each of the plurality of electrode matrices; and determining the optimal electrode matrix from the plurality of electrode matrices based on the electrophysiological response, includes:

[0063] Each of the plurality of electrode matrices is used to electrically stimulate the stimulation point using an electrical stimulation signal of first intensity.

[0064] Collect the electrophysiological response corresponding to each electrode matrix in the plurality of electrode matrices;

[0065] Based on the electrophysiological response, each electrode matrix among the plurality of electrode matrices is scored, and the electrode matrix with the best score is determined as the optimal electrode matrix.

[0066] Referring to Figure 3, which is a flowchart illustrating the determination of the optimal electrode matrix provided in an embodiment of this application, the process includes the following steps:

[0067] Step 301: Detect the impedance of each electrode point.

[0068] Detect the impedance of each electrode point and remove high-impedance and open-circuit electrodes from the options.

[0069] Step 302: Determine multiple electrode matrices.

[0070] Multiple electrode matrices are determined based on the normal multiple electrode points.

[0071] Step 303: Select an electrode matrix that has not been measured from multiple electrode matrices and apply an electrical stimulation signal.

[0072] Here, the intensity of the electrical stimulation signal used in each electrode matrix is ​​the same.

[0073] Step 304: Detect whether there is an electrophysiological response.

[0074] If there is no electrophysiological response, return to step 303; if there is an electrophysiological response, proceed to step 305.

[0075] Step 305: Add the matrix to the scoring queue.

[0076] The matrix is ​​scored based on the electrophysiological response, and the matrix and its score are added to the scoring queue.

[0077] Step 306: Is this the last set of matrices?

[0078] If it is not the last set of matrices, return to step 303; if it is the last set of matrices, proceed to step 307.

[0079] Step 307: Select the optimal electrode matrix based on the scores.

[0080] Based on the scores of each electrode matrix, the best electrode matrix is ​​selected from multiple electrode matrices.

[0081] In one optional embodiment of this application, the step of scoring each electrode matrix among the plurality of electrode matrices based on the electrophysiological response includes:

[0082] The electrophysiological response is preprocessed, and features are extracted from the preprocessed electrophysiological response to obtain the physiological response features corresponding to the electrophysiological response.

[0083] Each electrode matrix in the plurality of electrode matrices is scored based on the physiological response characteristics.

[0084] In this embodiment of the application, the preprocessing includes one or more of the following processing methods: amplification, filtering, sampling, segmentation analysis of serial ports, and noise reduction.

[0085] For example, taking electromyography (EMG) signals as an electrophysiological response, referring to Figure 4, which is a flowchart of EMG signal scoring provided in an embodiment of this application, the steps include:

[0086] Step 401: Acquire electromyographic signals.

[0087] Step 402: Preprocess the electromyographic signals.

[0088] Preprocessing includes one or more of the following methods: amplification, filtering, sampling, segmentation analysis of serial ports, noise reduction, etc.

[0089] Step 403: Extract features from electromyographic signals.

[0090] In the embodiments of this application, the elements referenced for evaluating electromyographic signals include one or more of the following.

[0091] Muscle response intensity is used to determine whether the stimulus location is accurate. In the permutation and combination closest to the nerve distribution, the maximum muscle response intensity can be obtained by using a known stimulus intensity.

[0092] Stimulation comfort is assessed by changes in skin resistance. High skin resistance may lead to concentrated current density, causing a stinging sensation and thus reducing comfort.

[0093] Delayed muscle fatigue is used to ensure that patients can maintain a stable therapeutic effect during a period of continuous treatment.

[0094] Signal stability is used to ensure that the signal can reach the user's treatment site evenly and effectively.

[0095] For example,

[0096] Muscle response intensity can be assessed using the root mean square (RMS) value of the EMG signal.

[0097] Stimulation comfort can be assessed by skin resistance; for example, comfort can be assessed by the variance of skin resistance over a certain period of time.

[0098] The delay in muscle fatigue can be assessed by changes in mean frequency (MNF) and median frequency (MDF).

[0099] Signal stability is assessed using waveform length (WL) and power spectral density (PSD).

[0100] Based on this, the features for capturing electromyographic signals include at least: root mean square value of EMG signal, skin resistance, intermediate frequency, median frequency, waveform length, power spectral density, and inflection point.

[0101] In this embodiment of the application, the features for capturing electromyographic signals also include: mean absolute value (MAV) and zero crossing (ZC).

[0102] For the above-mentioned feature points, the electromyographic signals have undergone specific preprocessing, including filtering: applying bandpass filters (e.g., 20-450Hz) to remove power frequency noise (e.g., 50 / 60Hz) and low-frequency baseline drift; and denoising: using wavelet transform, empirical mode decomposition, and other methods to remove high-frequency noise and other interference.

[0103] The waveform length can be obtained directly through measurement.

[0104] For RMS values, the preprocessed EMG signal is first divided into multiple short time windows. The length of each time window can be determined according to the specific application, such as 20ms, 50ms, or 100ms. The data for each time window is calculated using the following formula: in, It represents the sampled value of the EMG signal within the time window, and N is the number of sampling points within the time window.

[0105] For frequency domain information such as PSD, MNF, and MDF, Fast Fourier Transform (FFT) can be used for processing; subsequently, PSD can be directly calculated to determine the energy distribution at different frequencies. MNF is the centroid of the power spectral density. The calculation method typically involves multiplying the frequency value at each frequency point by the corresponding power value, summing the products of all frequency points, and finally dividing by the total power value. MDF represents the median of the power spectral density; it is calculated by sorting the power spectral densities by magnitude and finding the middle frequency point. If the number of frequency points is odd, the middle point is the MDF; if the number of frequency points is even, the average of the two middle points is taken as the MDF.

[0106] Step 404: Evaluate the characteristics of electromyographic signals.

[0107] For example, the following is a scoring method: Considering that tolerance to electrical stimulation varies from person to person, the assessment score calculation will appropriately incorporate the user's personal feedback to determine whether the treatment intensity exceeds the tolerance level or fails to meet personal expectations. The user's personal feedback can be scored based on their own feelings:

[0108] Electrode matrix score = muscle response intensity * 0.2 + stimulation comfort * 0.2 + muscle fatigue * 0.15 + signal stability * 0.15 + user feedback * 0.2.

[0109] Understandably, this application does not limit the rating method. For example, without considering individual user feedback, the rating method could also be:

[0110] Electrode matrix score = muscle response intensity * 0.3 + stimulation comfort * 0.3 + muscle fatigue * 0.15 + signal stability * 0.15.

[0111] It should be noted that the electrophysiological response of electromyography signal is only an example of the electrophysiological response provided in the embodiments of this application. In actual application, the electrophysiological response may include one or more physiological response information in the nervous system and / or cardiovascular system and / or muscular system and / or circulatory system caused by electrical stimulation.

[0112] Step 104: Apply electrical stimulation to the stimulation point using the optimal electrode matrix.

[0113] In this embodiment of the application, before applying the optimal electrode matrix to the stimulation point for electrical stimulation, it is detected whether there are abnormal electrode points in the optimal electrode matrix. Electrode points with high impedance and open circuits are removed to obtain a first electrode matrix. The first electrode matrix is ​​used to apply electrical stimulation to the stimulation point with a first intensity. The electrophysiological response corresponding to the first electrode matrix is ​​collected. The first electrode matrix is ​​scored based on the electrophysiological response and compared with the electrode matrices in the scoring queue to redetermine the optimal electrode matrix.

[0114] Based on this, in one optional embodiment of this application, it further includes:

[0115] A scoring queue is obtained based on the scores of each electrode matrix in the plurality of electrode matrices;

[0116] Before applying the optimal electrode matrix to the stimulation point, the procedure further includes:

[0117] Check whether each electrode point in the optimal electrode matrix is ​​normal;

[0118] If there are abnormal electrode points in the optimal electrode matrix, the abnormal electrode points are removed from the optimal electrode matrix to obtain the first electrode matrix;

[0119] Based on the scoring queue and the first electrode matrix, the optimal electrode matrix is ​​determined again.

[0120] For example, the frequency and amplitude of the electrical stimulation signal are selected to stimulate the tibial nerve. For this purpose, the current is typically in the form of a bipolar wave with a frequency in the range of 10Hz-120Hz, and the stimulation intensity is modulated by adjusting the pulse width (typically in the range of 10µs-1000µs) with a fixed current. More specifically, a square wave with a frequency of approximately 20Hz and an amplitude in the range of 70µs-560µs is considered therapeutically effective. Alternatively, other waveforms with different frequency and amplitude characteristics can be applied. The control module includes a stimulation circuit comprising components known in the art for generating electrical waveforms.

[0121] In practical applications, if square wave electrical stimulation signals are used for electrical stimulation, when the intensity of nerve stimulation reaches the effective treatment level, the patient will feel a strong stinging sensation, which will cause discomfort to the patient, affect the patient's compliance with treatment, and affect the treatment effect.

[0122] In this embodiment, the electrical stimulation signal can be a pulse signal with a curved envelope, and the stimulation circuit is configured to generate a pulse signal with a curved envelope as the electrical stimulation signal.

[0123] The curve here can be a sine envelope, a cosine envelope, or other curve envelopes; this application does not limit this.

[0124] In this embodiment of the application, the electrostimulation system further includes: a terminal APP and / or a display screen, which analyzes the electrophysiological responses collected during the electrostimulation process, obtains treatment parameters, and displays the treatment parameters visually.

[0125] In this embodiment of the application, taking electrophysiological response as electromyography (EMG) signal as an example, the treatment parameters include: electrode matrix used for electrical stimulation, electrical stimulation signal intensity, EMG signal intensity, treatment duration, treatment frequency, etc., wherein the electrical stimulation signal intensity and EMG signal intensity can be characterized by pulse width and / or current intensity.

[0126] In this embodiment, after determining the optimal electrode matrix, one or more electrode matrix combinations can be determined based on the electrode points of the optimal electrode matrix. For example, the optimal electrode matrix is ​​(A, B, C: D, E, F), which can realize nine pathways: AD, AE, AF, BD, BE, BF, CE, CD, and CF. An electrode matrix combination can include one or more pathways. For example, (AD, BE, CF) is an electrode matrix combination. The user can select the first electrode matrix combination for electrical stimulation based on the experience of using one or more electrode matrix combinations. It is understood that the pathways realized by the electrode matrix (A, B, C: D, E, F) in this application are not limited to a one-to-one positive pole pathway. They can also realize pathways such as one positive pole to multiple negative poles, multiple positive poles to one negative pole, and multiple positive poles to multiple negative poles, for example, (A: DE), (AB: E), (AB: EF), etc.

[0127] Based on this, in an optional embodiment of this application, the electrical stimulation method further includes:

[0128] Based on the electrode points of the optimal electrode matrix, one or more combinations of electrode matrices are determined; the combinations of electrode matrices include multiple electrode matrices.

[0129] Electrical stimulation is performed using a first electrode matrix combination; the first electrode matrix combination is an electrode matrix combination selected by the user from one or more electrode matrix combinations.

[0130] In an optional embodiment of this application, after electrically stimulating the stimulation point using the optimal electrode matrix, the method further includes:

[0131] Acquire electrophysiological responses during electrical stimulation;

[0132] The electrophysiological response was analyzed to obtain treatment parameters;

[0133] The treatment parameters are visualized.

[0134] In one optional embodiment of this application, the electrical stimulation system further includes: a terminal APP and / or a physical button module; the method further includes:

[0135] The system receives a first operation and adjusts the intensity of electrical stimulation based on the first operation; the first operation is an operation performed by the user on the terminal APP and / or physical button module.

[0136] Here, the first operation is for the user to adjust the intensity of electrical stimulation through the terminal APP and / or physical button module.

[0137] In an optional embodiment of this application, the method further includes: stopping the electrical stimulation when the electrical stimulation time reaches a predetermined time.

[0138] Here, the scheduled time can be designed according to actual needs, and this application does not impose any restrictions on it.

[0139] In an optional embodiment of this application, the method further includes: receiving a second operation; the second operation is an operation of the user recording first information; the first information includes one or more of the following: user personal information and self-monitoring data of the treatment process;

[0140] Based on the first information, generate a quality of life report; and / or,

[0141] Based on the first information, a user profile is created; the optimal electrode matrix is ​​then imported into the user profile.

[0142] In this embodiment, users can record personal information and self-monitoring data of the treatment process through a terminal APP.

[0143] Personal information includes age, gender, etc.; self-monitoring data during treatment can be set according to different diseases. For example, if the disease is OAB, urination frequency, urine volume, etc. can be recorded. Based on the information recorded by the user, a quality of life report can be generated for the doctor or user's reference.

[0144] Figure 5 is a schematic diagram of the implementation process of the electrostimulation method provided in this application embodiment. As exemplarily shown in Figure 5, in the electrostimulation method provided in this application embodiment, the electrophysiological response is an electromyographic signal, and it is targeted at OAB patients. The method includes the following steps:

[0145] Step 501: Turn on the electrical stimulation host.

[0146] Here, the electrical stimulation host can be turned on via physical buttons and / or a terminal APP.

[0147] Step 502: Select whether to connect to the terminal APP.

[0148] After the electrical stimulation host is powered on, the user determines whether to connect the electrical stimulation host to the terminal APP. If the electrical stimulation host is not connected to the terminal APP, then proceed to steps 503-506; if the electrical stimulation host is connected to the terminal APP, then proceed to steps 507-5014.

[0149] Step 503: Perform treatment using a preset electrode matrix.

[0150] Here, the electrical stimulation host can be set with a default electrode matrix. When the user does not select the optimal electrode matrix, the default electrode matrix will be used for electrical stimulation.

[0151] Step 504: The user adjusts the intensity of the electrical stimulation based on their experience.

[0152] Users can adjust the intensity of electrical stimulation using physical buttons based on the stimulation intensity and / or comfort level.

[0153] Step 505: Determine whether the preset treatment time has been reached.

[0154] If the preset treatment time has not been reached, continue electrical stimulation; if the preset treatment time has been reached, proceed to step 506.

[0155] Step 506: Treatment complete, electrical stimulation unit turned off.

[0156] Step 507: Create user profiles.

[0157] Users can record information such as age, gender, frequency of urination before treatment, and urine volume before treatment, and a user profile can be built based on the information recorded by the user.

[0158] Step 508: Determine the optimal electrode matrix.

[0159] Multiple electrode matrices are determined based on multiple electrode points on the stimulation electrode pads; each electrode matrix is ​​scored based on the EMG signal corresponding to the stimulation point to obtain a scoring queue; and the optimal electrode matrix is ​​determined based on the scoring queue.

[0160] Step 509: Perform electrical stimulation using the optimal electrode matrix.

[0161] The optimal electrode matrix is ​​used, and the appropriate electrical stimulation intensity is set for electrical stimulation.

[0162] Step 510: The user adjusts the intensity of the electrical stimulation based on their experience.

[0163] During treatment, users can adjust the intensity of electrical stimulation via physical buttons and / or a mobile app based on the stimulation intensity and comfort level.

[0164] Step 511: Determine whether the preset treatment time has been reached.

[0165] If the preset treatment time has not been reached, continue electrical stimulation; if the preset treatment time has been reached, stop electrical stimulation and proceed to step 3012.

[0166] Step 512: Import the treatment parameters into the corresponding user profile.

[0167] Treatment parameters are obtained by analyzing the EMG during electrical stimulation and then imported into the user profile.

[0168] Step 513: Record self-monitoring data during the treatment process.

[0169] Users record information such as urination frequency and urine volume during electrical stimulation to create a bladder diary and / or quality of life report.

[0170] Step 514: The doctor adjusts the treatment parameters.

[0171] Based on the bladder diary and / or quality of life reports, the doctor adjusts the treatment parameters and sets the intensity of electrical stimulation for the next treatment.

[0172] For example, in the electrical stimulation method provided in this application embodiment, the first stimulation electrode pad is positioned approximately four finger-widths above the medial malleolus. The electrode pad contains a 2x2 matrix of stimulation electrodes, which are geometrically symmetrical to cover adjacent left-right and vertically vertical skin areas. The vertical coverage utilizes the distribution of the body's own nerves, while the left-right coverage accommodates potential human error during application. Similarly, the second electrode pad, located midway between the medial malleolus tip and the heel, also contains a 2x2 matrix of stimulation electrodes, which are geometrically symmetrical to cover adjacent left-right and vertically vertical skin areas. The left-right coverage utilizes the distribution of the body's own nerves, while the vertical coverage accommodates potential human error during application. The detection electrode pad can be placed between the (most) distal motor endplate region and the corresponding tendon of the abductor hallucis muscle. Conversely, the corresponding reference electrode is placed on the dorsum of the foot where no related muscle group exists, to improve the signal-to-noise ratio. The control module can actively configure the stimulator to at least 16 matching stimulation pathways (A1: B1, B2, B3, B4; A2: B1, B2, B3, B4; A3: B1, B2, B3, B4; A4: B1, B2, B3, B4). Based on the evaluation of stimulation effect, multiple stimulation pathways can also be open simultaneously, such as a single positive electrode corresponding to multiple negative electrodes, multiple positive electrodes corresponding to multiple negative electrodes, or multiple positive electrodes corresponding to a single negative electrode (A1, A2: B1). Based on the different stimulation pathways, the stimulation of the tibial nerve will predictably differ; inducing contraction of the abductor hallucis (AH) muscle in the plantar surface, for a single user, given a known equivalent stimulation intensity, the stimulation contraction response at the optimal stimulation point will be stronger than at other potentials. Therefore, by selecting this stimulation site, the corresponding stimulation intensity can be reduced to improve user comfort and tolerance. However, this contraction response is often indistinguishable to the naked eye or through self-perception. Therefore, the returned electromyographic (EMG) signal is transmitted back to the control module via detection electrode pads. The control module's detection circuit performs preprocessing of the raw signal (including amplification, filtering, sampling, and serial port segmentation analysis), data display, and data comparison. After comparing all selectable channels, the optimal stimulation pathway, i.e., the optimal electrode matrix, is automatically configured. The stable geometry of the stimulation electrode matrix provides improved control over the stimulation signal. By combining the analysis of EMG signal characteristics generated by the induced muscle response, the control module or terminal APP can automatically plan the stimulation electrode matrix. Because a stable and repeatable stimulation geometry is applied to the skin surface, the stimulation matrix can better target the nerve stimulation site.

[0173] Referring to Figure 6, which is a schematic diagram of the structure of the electrostimulation system 600 provided in an embodiment of this application, the electrostimulation system 600 includes: a control module, a detection module, and an electrostimulation module; the electrostimulation module includes: a stimulation electrode sheet; and the surface of the stimulation electrode sheet is provided with multiple electrode points;

[0174] The control module is configured to determine multiple electrode matrices based on the multiple electrode points;

[0175] The control module is further configured to apply electrical stimulation to the stimulation point using each of the plurality of electrode matrices;

[0176] The detection module is configured to collect the electrophysiological response corresponding to each of the plurality of electrode matrices; the electrophysiological response is the physiological response information caused by electrical stimulation when each of the plurality of electrode matrices is used to electrically stimulate the stimulation point;

[0177] The control module is further configured to determine the optimal electrode matrix from the plurality of electrode matrices based on the electrophysiological response;

[0178] The control module is also configured to apply electrical stimulation to the stimulation point using the optimal electrode matrix.

[0179] In this embodiment of the application, the electrophysiological response includes one or more of the following information:

[0180] Information includes compound action potentials, electromyographic signals, local blood flow, muscle spatial displacement, and heart rate.

[0181] In this embodiment of the application, the control module is further configured to determine one or more electrode matrix combinations based on the electrode points of the optimal electrode matrix; the electrode matrix combination includes multiple electrode matrices.

[0182] The control module is further configured to perform electrical stimulation using a first electrode matrix combination; the first electrode matrix combination is an electrode matrix combination selected by the user from one or more electrode matrix combinations.

[0183] For example, the frequency and amplitude of the electrical stimulation signal are selected to stimulate the tibial nerve. For this purpose, the current is typically in the form of a bipolar wave with a frequency in the range of 10Hz-120Hz, and the stimulation intensity is modulated by adjusting the pulse width (typically in the range of 10µs-1000µs) with a fixed current. More specifically, a square wave with a frequency of approximately 20Hz and an amplitude in the range of 70µs-560µs is considered therapeutically effective. Alternatively, other waveforms with different frequency and amplitude characteristics can be applied. The control module includes a stimulation circuit comprising components known in the art configured for generating electrical waveforms.

[0184] In practical applications, if square wave electrical stimulation signals are used for electrical stimulation, when the intensity of nerve stimulation reaches the effective treatment level, the patient will feel a strong stinging sensation, which will cause discomfort to the patient, affect the patient's compliance with treatment, and affect the treatment effect.

[0185] In this embodiment, the electrical stimulation signal can be a pulse signal with a curved envelope, and the stimulation circuit is configured to generate a pulse signal with a curved envelope as the electrical stimulation signal.

[0186] The curve here can be a sine envelope, a cosine envelope, or other curve envelopes; this application does not limit this.

[0187] Referring to Figure 7, which is a schematic diagram of the stimulation circuit provided in an embodiment of this application, the stimulation circuit includes: a constant current module, a microcontroller (MCU), and an H-bridge circuit; wherein,

[0188] The constant current module is connected to the H-bridge circuit and is configured to provide current to the H-bridge circuit.

[0189] The MCU is connected to the H-bridge circuit and configured to send a control signal to the H-bridge circuit. The control signal is used to control the H-bridge circuit to generate a pulse signal with a curved envelope.

[0190] Referring to Figure 8, which is a schematic diagram of the constant current module, H-bridge circuit, and MCU provided in the embodiment of this application, the H-bridge circuit includes: metal-oxide-semiconductor field-effect transistors (MOSFETs) Q2, Q3, Q4, and Q5; the gate of each MOSFET is connected to the MCU and configured to receive control signals SW1, SW2, SW3, and SW4 sent by the MCU. Q2, Q3, Q4, and Q5 correspond to control signals SW1, SW2, SW3, and SW4, respectively; the source of Q2 is connected to the drain of Q3 and then connected to one electrode, and the source of Q4 is connected to the drain of Q5 and then connected to the other electrode. The two electrodes are connected to the human body.

[0191] The constant current module includes: operational amplifier U3.1, resistor RS1, capacitor U4, resistor RS3, resistor RS2, and an operational amplifier equipped with a 5V regulated DC power supply. The DAC is connected to the positive input terminal of the operational amplifier, and the negative terminal of the operational amplifier is connected to the corresponding Iout feedback signal and transistor Q6. The collector of Q6 is connected to the H-bridge circuit. The base current of transistor Q6 is adjusted by the feedback information of the operational amplifier, thereby regulating the output current. This configuration ensures a stable current output when the H-bridge switches to output complex envelope waveforms.

[0192] For example, taking the case of generating a forward voltage as an example, after the drains of MOSFET Q2 and MOSFET Q5 are turned on, they are connected to the high-voltage output. The final output then contacts the user through the body surface electrodes, forming a path (defined as a forward voltage). Similarly, after the drains of MOSFET Q3 and MOSFET Q4 are turned on, they are connected to the high-voltage output. The final output then contacts the user through the body surface electrodes, forming a path (defined as a reverse voltage). Therefore, the MCU can control the on / off state of Q2, Q4, Q3, and Q5 using control signals SW1, SW2, SW3, and SW4, causing the H-bridge circuit to generate a pulse signal with a curved envelope. For example, when Q2 and Q5 are on and Q3 and Q4 are off, current flows forward through the load. When Q3 and Q4 are on and Q2 and Q5 are off, current flows backward through the load. Based on this principle, different waveforms can be generated by repeatedly controlling the on / off state.

[0193] Referring to Figure 8, in an optional embodiment of this application, the stimulation circuit further includes: a sampling module;

[0194] The sampling module is connected to the H-bridge circuit and the MCU, and is configured to collect the operating parameters of the H-bridge circuit, obtain a sampling signal, and send the sampling signal to the MCU;

[0195] The MCU is configured to receive the sampling signal and adjust the control signal according to the sampling signal.

[0196] Here, the operating parameters of the H-bridge circuit include current and / or voltage.

[0197] Referring to Figure 9, which is a schematic diagram of the boost module provided in an embodiment of this application, the boost module in this embodiment includes: a boost power supply VBAT, a transformer Lp, a capacitor C1, an inductor U1, a diode D2, a transistor Q1, a PWM power supply, a diode D3, an electrolytic capacitor C2, and a capacitor U2. One end of U2, C2, and D3 is connected to the H-bridge circuit to provide the voltage required for the stimulation circuit to generate the electrical stimulation signal and enhance the intensity of the electrical stimulation signal.

[0198] Based on this, in this embodiment of the application, the stimulation circuit further includes a boost module, which is connected to the H-bridge circuit and configured to enhance the intensity of the electrical stimulation signal.

[0199] By generating pulsed electrical stimulation signals with curved envelopes, the electrode pads transmit the electrical stimulation signals to the tibial nerve. The electrical stimulation system can gradually increase or decrease the stimulation intensity with higher resolution within the same amplitude of change. The gradual and smooth intensity changes can significantly reduce the discomfort caused by sudden changes, making it easier for patients to adapt to each change without feeling a sudden and intense stinging sensation. This reduces patients' resistance during treatment and increases the tolerance of the therapy.

[0200] In this embodiment, the stimulation electrode pads are configured to transmit electrical stimulation signals to the user's skin. Optional connection methods include, but are not limited to, integrated wires, button connections, and magnetic connections. For example, referring to Figure 10, which is a schematic diagram of the placement of the stimulation electrode pads provided in this embodiment, as shown in Figure 10, the negative stimulation electrode pad is placed at the Fuliu acupoint approximately four finger-widths above the medial malleolus, and the positive stimulation electrode pad is placed at the Taixi acupoint, located between the tip of the medial malleolus and the heel, to provide stimulation and modulation of the tibial nerve.

[0201] In this embodiment, the stimulation electrode pad includes multiple electrode points, which can form multiple electrode matrices. For example, the positive and negative stimulation electrode pads have equal areas, and geometrically, the distance from their center points to the center of the electrode pad is less than or equal. During treatment, the electrode matrix can be configured according to the patient's specific feedback. For example, if the positive stimulation electrode pad has three electrodes (A, B, and C) and the negative stimulation electrode pad has three electrodes (D, E, and F), the output can be set through the control module to achieve nine pathways: AD, AE, AF, BD, BE, BF, CE, CD, and CF. For example, the electrode pads are covered with hydrogel, which can adapt to different body surfaces, maintaining the stability and reliability of the electrodes. In this embodiment, the stimulation electrode pads can be combined with wearable fabric accessories via zippers, Velcro, elastic bands, etc., to provide a wearable treatment experience.

[0202] In this embodiment, the detection module includes detection electrode pads and reference electrode pads, configured to provide direct contact with the patient's body to acquire the required potential signals (e.g., evoked compound action potential "ECAP") or evoked EMG electromyographic signals. Optional connection methods for the detection electrode pads include, but are not limited to, integrated wires, button connections, magnetic connections, etc. For example, electrical stimulation of the tibial nerve induces contraction of the abductor hallucis muscle (AHM) on the plantar surface. The detection electrode pads can be placed between the distal motor endplate region and the distal tendon to obtain the best longitudinal detection results; or the detection electrodes can be placed on the surface of other subdivided regions or muscles away from the "edge" to maximize the distance between the muscle and these subdivided regions and other muscles to obtain the best lateral detection results. After determining and marking the sensor positions, the detection electrode pads need to be placed and fixed around the marked positions. When placing and fixing the electrodes, the distance between the electrodes, the orientation, the fixing method, and the position of the reference electrode are selected. For example, "inter-electrode distance" is defined as the center-to-center distance between the conductive regions of two bipolar electrodes; "direction" is defined as the position of the line between the two bipolar electrodes relative to the muscle fiber direction; the electrode orientation has a significant impact on the recorded sEMG. The reference electrode pad needs to be placed in a location with minimal risk of large common-mode interference signals. For example, the reference electrode pad can be placed on non-electrolyzed tissue, and multiple reference electrode pad locations can be used. The reference electrode pad can be placed on the skin away from the target moving muscle. In this embodiment, the electrode pad is covered with hydrogel to ensure the signal-to-noise ratio and repeatability of the electromyographic signal.

[0203] In this embodiment of the application, the control module is further configured to use each of the plurality of electrode matrices to electrically stimulate the stimulation point through an electrical stimulation signal of the first intensity;

[0204] The detection module is configured to collect the electrophysiological response corresponding to each of the plurality of electrode matrices;

[0205] The control module is further configured to score each electrode matrix among the plurality of electrode matrices based on the electrophysiological response, and determine the electrode matrix with the best score as the optimal electrode matrix.

[0206] In this embodiment of the application, the control module is further configured to obtain a scoring queue based on the scores of each electrode matrix in the plurality of electrode matrices;

[0207] The control module is also configured to detect whether each electrode point in the optimal electrode matrix is ​​normal;

[0208] The control module is further configured to remove abnormal electrode points from the optimal electrode matrix if there are abnormal electrode points in the optimal electrode matrix, thereby obtaining a first electrode matrix.

[0209] The control module is also configured to redetermine the optimal electrode matrix based on the scoring queue and the first electrode matrix.

[0210] In this embodiment of the application, the control module is further configured to preprocess the electrophysiological response, extract features from the preprocessed electrophysiological response, and obtain the physiological response features corresponding to the electrophysiological response.

[0211] The control module is also configured to score each electrode matrix among the plurality of electrode matrices based on the physiological response characteristics.

[0212] In this embodiment, the control module includes a detection circuit. The main function of the detection circuit is to acquire the corresponding physiological response information induced by electrical stimulation, detected on the skin surface and transmitted back from the detection electrode pads. For this purpose, the detection circuit needs to perform operations such as amplification, filtering, sampling, and segmentation analysis via a serial port. Adjustable parameters include gain factor and sampling frequency. After preprocessing, the data is sent back to the terminal APP via the communication module. The communication module of the electrical stimulation system can use Bluetooth, WIFI, and other wireless protocols for secure and wireless communication. This transmits information such as detection signals and the status of the host device (e.g., battery level, output treatment parameters) to the user's personal terminal (e.g., smartphone, tablet, smartwatch), and receives control information (e.g., start / stop treatment, stimulation intensity adjustment) transmitted by the mobile terminal component.

[0213] In this embodiment of the application, the detection module is further configured to collect the electrophysiological response during the electrical stimulation process;

[0214] The control module is also configured to analyze the electrophysiological response to obtain treatment parameters;

[0215] The electrical stimulation system further includes: a display module and / or a terminal APP; wherein...

[0216] The display module is configured to visualize the treatment parameters;

[0217] The terminal APP is configured to visualize the treatment parameters.

[0218] In this embodiment of the application, the display module and / or the terminal APP may also display one or more electrode matrix combinations for the user to select.

[0219] In this embodiment of the application, the electrical stimulation system further includes: a physical button module and / or a terminal APP; wherein,

[0220] The physical button module is configured to receive a first operation, wherein the first operation is an operation by which the user adjusts the intensity of electrical stimulation; and / or, the terminal APP is configured to receive a first operation, wherein the first operation is an operation by which the user adjusts the intensity of electrical stimulation.

[0221] The control module is also configured to adjust the intensity of electrical stimulation based on the first operation.

[0222] In this embodiment of the application, the control module is further configured to stop the electrical stimulation when the electrical stimulation time reaches a predetermined time.

[0223] In this embodiment of the application, the electrical stimulation system further includes: a terminal APP;

[0224] The terminal APP is configured to receive a second operation; the second operation is the user recording first information; the first information includes: user personal information and self-monitoring data of the treatment process.

[0225] The control module is further configured to generate a quality of life report based on the first information; and / or,

[0226] The control module is also configured to establish a user profile based on the first information and import the optimal electrode matrix into the user profile.

[0227] In this embodiment of the application, the electrical stimulation system further includes: a fabric accessory;

[0228] The fabric accessory is configured to combine the physical modules of the electrical stimulation system into a wearable body.

[0229] In this embodiment, the main function of the fabric accessory is to combine the physical modules of the electrical stimulation system into a wearable main body. For example, it combines the control module, detection electrode pads, and stimulation electrode pads into a wearable main body for easy patient use. The components are connected to the fabric accessory via Velcro, elastic bands, elastic pouches, zippers, buttons, etc. The fabric accessory provides additional pressure to the electrode pads beyond the adhesive properties of the hydrogel, ensuring a close fit between the electrodes and the body. The wearable design of the fabric accessory fully considers the possibility of urinary urgency or frequency during treatment, allowing patients to use the toilet during the treatment process.

[0230] In this embodiment, the fabric accessory is designed with a specific alignment structure. For example, a rigid component can be added at the thumb pressing point to facilitate the attachment of the detection electrode to the abductor phantom muscle in the same direction as the thumb; for example, the center of the ankle strap is aligned with the medial malleolus tip to provide more accurate electrical stimulation. The appearance of the fabric accessory can refer to that of an ankle brace, and its structural design includes, but is not limited to, sock-like, bandage-like, strap-like, or combined types. Based on the different body types of different patients, fabric accessories of different sizes can be designed to match, or buckle / limiting designs suitable for different populations can be used in the fabric accessory to ensure accurate and effective stimulation sites.

[0231] In this embodiment, the stimulator host includes a control module, a physical button module, a display module, a communication module, and a detection module. The stimulator host provides electrical stimulation signals to the stimulation electrode pads connected to it and acquires electromyographic signals generated by stimulating specific nerves from the detection electrode pads connected to it. The control module includes circuitry configured to operate sensors such as accelerometers, electrodes capable of sensing impedance, or physiological measurements. These measurements can be sent to an evaluation management module to evaluate measurements such as heart rate, evoked nerve potentials, for example, evoked compound action potentials, or evoked electromyographic signals. The control module also includes optical sensors, such as those configured to measure heart rate or blood oxygen levels, and sensors configured to acquire data related to humidity and skin temperature or derive cardiac measurements such as blood pressure.

[0232] In this embodiment, the communication module can "shake hands" with the terminal and use Bluetooth, WIFI and other wireless protocols for secure and wireless communication, so as to transmit information such as detection signals and the status of the host device (such as battery level, output treatment parameters), or receive control information (such as start, stop treatment, stimulation intensity adjustment) transmitted by the terminal. The terminal can be a tablet, mobile phone, computer, etc.

[0233] In this embodiment of the application, the stimulator host further includes a battery module; the battery module includes a rechargeable lithium battery.

[0234] In this embodiment, the stimulator host can be combined with wearable fabric accessories via components such as zippers, Velcro, and elastic bands to provide a wearable therapeutic experience.

[0235] In this embodiment, the physical button module includes multiple physical buttons, which are set on the stimulator panel for functions such as stimulator parameter adjustment and Bluetooth connection.

[0236] In this embodiment of the application, the stimulator host can be protected by a housing. For example, the housing includes a suitable plastic shell that is bonded by laser, ultrasound or other applicable processing means. The housing also includes a suitable charging plug, stimulation signal and detection signal input and output interfaces, as well as structures such as retaining rings and buckles that can be combined with fabric accessories.

[0237] In this embodiment, the terminal APP can be installed on a mobile device such as a tablet, mobile phone, or smartwatch, and establish a connection with the stimulator host, using Bluetooth, WIFI, and other wireless protocols for secure and wireless communication. This allows for the transmission of information such as detection signals and the status of the host device (e.g., battery level, output treatment parameters), or the receipt of control information (e.g., start / stop treatment, stimulation intensity adjustment) from the mobile terminal component. The terminal APP can provide one or more of the following functions: data visualization of treatment and detection signals; providing user manuals and guidelines for the electrical stimulation system; recording the patient's treatment plan and providing timely reminders; and automatically adjusting output parameters based on the patient's comfort feedback.

[0238] Those skilled in the art should understand that the functions of each unit in the electrostimulation system 600 shown in Figure 6 can be understood with reference to the relevant description of the foregoing method. The functions of each unit in the electrostimulation system 600 shown in Figure 6 can be implemented by a program running on a processor or by specific logic circuits.

[0239] Referring to Figures 11a, 11b, and 11c, which are schematic diagrams of the electrical stimulation system provided in this application from different angles, the stimulation electrode 1 is a negative stimulation electrode placed at the Fuliu acupoint, and the stimulation electrode 2 is a positive stimulation electrode placed at the Taixi acupoint. The electrodes can be fixed at the ankle using elastic bands or Velcro. Two detection electrodes, detection electrode 1 and detection electrode 2, are placed on the sole of the foot, and a reference electrode is placed on the instep. The instep can also be fixed using elastic bands or Velcro. The wires connected to the electrode plates can be combined with fabric accessories. Additionally, a support component, such as a flexible polymer or metal, can be provided. For example, the metal component can be an aluminum alloy, configured to fix the position of the fabric.

[0240] Referring to Figure 12, which is a schematic diagram of the electrode sheet provided in an embodiment of this application, as shown in Figure 9, the electrode sheet can be configured as a wire interface or a button-type interface, and this application does not limit this. The wire interface can be a pin-type connection socket, and the diameter can be 2.0mm, 2.5mm, or 5.0mm, etc., which can be set according to actual needs, and this application does not limit this.

[0241] Referring to Figure 13, which is a schematic diagram of the structure of an electrical stimulation system 1300 provided in an embodiment of this application, the electrical stimulation system 1300 includes:

[0242] Microcontroller Unit (MCU): Connected to communication module, touch screen, LED indicator, visualization window, audio output, physical buttons, power management module, high-voltage BOOST circuit control, DAC unit, timer setting, waveform setting, ADC unit, and overload / overcurrent protection module; configured at least to: control the electrical stimulation signal circuit to perform electrical stimulation; receive EMG signals and transmit them back to the terminal for processing; receive control signals from the terminal and adjust the corresponding output or implement related functions according to the control signals.

[0243] Touchscreen: Connected to the MCU, configured to receive user input and send user input information to the MCU;

[0244] LED indicator lights: Connected to the MCU and configured to display the operating status of the electrical stimulation system; for example, the light turns on when the electrical stimulation system is turned on and turns off when the electrical stimulation system is turned off.

[0245] Visualization window: Connects to the MCU and is configured to display parameters of the electrical stimulation system and / or treatment parameters at the user end;

[0246] Audio output: Connects to the MCU and is configured to play sounds, such as indicating the start or end of treatment, or generating error messages related to electrode detachment;

[0247] Physical buttons: connected to the MCU, configured to receive user operations and send operation information to the MCU;

[0248] Power management module: connected to the physical power button, rechargeable battery, and power supply circuit; configured to manage the battery and power supply of the electrical stimulation system;

[0249] The high-voltage BOOST circuit is controlled and connected to the MCU, stimulation signal output circuit, and negative voltage circuit. It is configured to provide the high voltage required by the stimulation signal output circuit to ensure that the stimulation signal can be output effectively.

[0250] Stimulation signal output circuit: connected to high-voltage BOOST circuit control, negative voltage circuit, and multi-point switching circuit, configured to generate stimulation signals based on feedback signals from the negative voltage circuit and / or user-defined parameters to achieve stimulation control;

[0251] Negative pressure circuit: Connected to the high-voltage BOOST circuit control and stimulation signal output circuit, it is configured to monitor the contact status between the stimulation electrode and the skin. Once an abnormality is detected, it can ensure the user's safety by cutting off the power or issuing an alarm.

[0252] Multi-point switching circuit: connected to the stimulation signal output circuit and stimulation electrode pads, configured as an electrode matrix to control electrical stimulation according to the control signal;

[0253] DAC unit: connected to the MCU, timer setting and stimulus signal output circuit; configured to output corresponding analog voltage or current according to the value of the digital input control signal, thereby controlling the intensity of the stimulus signal.

[0254] Timer settings: Connects to the MCU, DAC unit, and stimulus signal output circuit; configured to control the on / off state of the stimulus signal output circuit;

[0255] Waveform settings: Connect to the MCU and configure it to control the stimulus signal output circuit to generate different forms of stimulus waveforms, such as sine waves, square waves, pulses, etc.

[0256] ADC Unit: Connected to the MCU and EMG detection module, configured to convert surface electromyography (EMG) signals (analog signals) into digital signals.

[0257] EMG detection module: Connected to the detection electrode, reference electrode and ADC unit, it is configured to capture and amplify electrical activity based on muscle contraction, essentially resembling a bias amplifier with filtering function.

[0258] Overload / overcurrent protection module: Connects to the MCU and is configured to cut off the power supply in time to protect the equipment and users in the event of overload and / or overcurrent.

[0259] Communication module: connects to the terminal and MCU, including: WIFI and / or Bluetooth module; configured to transmit communication information between the terminal and the MCU;

[0260] Terminal: Connected to the communication module, configured to visualize electrical stimulation system data, record treatment, conduct online consultations, adjust treatment parameters, generate bladder diaries and quality of life reports.

[0261] The electrical stimulation method provided in this application embodiment achieves non-invasive electrical stimulation therapy by using transdermal electrode patches. A supporting terminal APP provides visualization of treatment parameters, device usage guidance, treatment reminders, and adjustment of stimulation intensity based on patient feedback. It also allows patients to record treatment frequency and urination frequency, improving treatment effectiveness by enhancing user compliance. A matrix-type stimulation array involving sensors acquires patient feedback information. This design ensures that the target nerve is fully covered by the electrode matrix, reducing differences in treatment effectiveness due to individual variations. Sensor feedback selects the optimal stimulation site. Based on the selection of the optimal stimulation site, the stimulation intensity can be reduced while minimizing output current, thus reducing stinging sensation during nerve stimulation therapy and improving patient comfort. Self-monitoring data recording during treatment (bladder diary) in the terminal APP generates a quality of life report, providing positive feedback to the patient. Electrode placement ensures sufficient fixation of the target nerve, making stimulation effective and delivered in a controlled manner. This reduces stinging sensation during nerve stimulation therapy, improving patient compliance. The wearable device fully considers the possibility of urinary urgency or frequency during treatment, allowing patients to urinate during the procedure.

[0262] Those skilled in the art should understand that the functions of each unit in the electrostimulation system 1300 shown in Figure 13 can be understood with reference to the relevant description of the foregoing method. The functions of each unit in the electrostimulation system 1300 shown in Figure 13 can be implemented by a program running on a processor or by specific logic circuits.

[0263] Figure 14 is a schematic structural diagram of an electronic device 1400 provided in an embodiment of this application. The electronic device 1400 shown in Figure 14 includes a processor 1410, which can call and run computer programs from memory to implement the methods in the embodiments of this application.

[0264] Optionally, as shown in FIG14, the electronic device 1400 may further include a memory 1420. The processor 1410 may retrieve and run computer programs from the memory 1420 to implement the methods in the embodiments of this application.

[0265] The memory 1420 can be a separate device independent of the processor 1410, or it can be integrated into the processor 1410.

[0266] Optionally, as shown in FIG14, the electronic device 1400 may further include a transceiver 1430, and the processor 1410 may control the transceiver 1430 to communicate with other devices. Specifically, it may send information or data to other devices or receive information or data sent by other devices.

[0267] The transceiver 1430 may include a transmitter and a receiver. The transceiver 1430 may further include an antenna, and the number of antennas may be one or more.

[0268] The electronic device 1400 may specifically be the electrical stimulation system 600 / electrical stimulation system 1300 in the embodiments of this application, and the electronic device 1400 can implement the corresponding processes implemented by the electrical stimulation system 600 / electrical stimulation system 1300 in the various methods of the embodiments of this application. For the sake of brevity, it will not be described in detail here.

[0269] For example, embodiments of this application also provide a computer program product, including a computer program that can be executed by a processor 1410 of an electronic device 1400 to perform the steps described in any of the foregoing methods.

[0270] Figure 15 is a schematic structural diagram of a chip according to an embodiment of this application. The chip 1500 shown in Figure 15 includes a processor 1510, which can call and run computer programs from memory to implement the methods in the embodiments of this application.

[0271] Optionally, as shown in FIG15, chip 1500 may further include memory 1520. Processor 1510 may retrieve and run computer programs from memory 1520 to implement the methods in the embodiments of this application.

[0272] The memory 1520 can be a separate device independent of the processor 1510, or it can be integrated into the processor 1510.

[0273] Optionally, the chip 1500 may also include an input interface 1530. The processor 1510 can control the input interface 1530 to communicate with other devices or chips; specifically, it can acquire information or data sent by other devices or chips.

[0274] Optionally, the chip 1500 may also include an output interface 1540. The processor 1510 can control the output interface 1540 to communicate with other devices or chips, specifically, to output information or data to other devices or chips.

[0275] The chip can be applied to the electrical stimulation system 600 / electrical stimulation system 1300 in the embodiments of this application, and the chip can implement the corresponding processes implemented by the electrical stimulation system 600 / electrical stimulation system 1300 in the various methods of the embodiments of this application. For the sake of brevity, it will not be described in detail here.

[0276] It should be understood that the chip mentioned in the embodiments of this application may also be referred to as a system-on-a-chip, system chip, chip system, or system-on-a-chip, etc.

[0277] It should be understood that the processor in the embodiments of this application may be an integrated circuit chip with signal processing capabilities. In implementation, the steps of the above method embodiments can be completed by integrated logic circuits in the processor's hardware or by instructions in software form. The processor described above can be a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other programmable logic devices, discrete gate or transistor logic devices, or discrete hardware components. It can implement or execute the methods, steps, and logic block diagrams disclosed in the embodiments of this application. The general-purpose processor can be a microprocessor or any conventional processor. The steps of the methods disclosed in the embodiments of this application can be directly embodied in the execution of a hardware decoding processor, or executed by a combination of hardware and software modules in the decoding processor. The software modules can be located in random access memory, flash memory, read-only memory, programmable read-only memory, electrically erasable programmable memory, registers, or other mature storage media in the art. The storage medium is located in memory, and the processor reads information from the memory and, in conjunction with its hardware, completes the steps of the above method.

[0278] It is understood that the memory in the embodiments of this application can be volatile memory or non-volatile memory, or may include both volatile and non-volatile memory. The non-volatile memory can be read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), or flash memory. The volatile memory can be random access memory (RAM), which is used as an external cache. By way of example, but not limitation, many forms of RAM are available, such as Static Random Access Memory (SRAM), Dynamic Random Access Memory (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDR SDRAM), Enhanced Synchronous DRAM (ESDRAM), Synchlink DRAM (SLDRAM), and Direct Rambus RAM (DR RAM). It should be noted that the memory used in the systems and methods described herein is intended to include, but is not limited to, these and any other suitable types of memory.

[0279] It should be understood that the above-described memory is exemplary and not a limiting description. For example, the memory in the embodiments of this application may also be static random access memory (SRAM), dynamic random access memory (DRAM), synchronous dynamic random access memory (SDRAM), double data rate synchronous dynamic random access memory (DDR SDRAM), enhanced synchronous dynamic random access memory (ESDRAM), synchronous link dynamic random access memory (SLDRAM), and direct memory bus RAM (DR RAM), etc. That is to say, the memory in the embodiments of this application is intended to include, but is not limited to, these and any other suitable types of memory.

[0280] This application also provides a computer-readable storage medium for storing a computer program. This computer-readable storage medium can be applied to the electrical stimulation system 600 / 1300 in the embodiments of this application, and the computer program causes a computer to execute the corresponding processes implemented by the electrical stimulation system 600 / 1300 in the various methods of the embodiments of this application. For the sake of brevity, further details are omitted here.

[0281] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0282] Those skilled in the art will understand that, for the sake of convenience and brevity, the specific working processes of the systems, devices, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0283] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between apparatuses or units may be electrical, mechanical, or other forms.

[0284] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0285] In addition, the functional units in the various embodiments of this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0286] If the aforementioned functions are implemented as software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a portion of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, a server, or an electrostimulation system 600 / 1300, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0287] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. An electrical stimulation system, the electrical stimulation system comprising: Control module, detection module, electrical stimulation module; The electrical stimulation module includes: a stimulation electrode pad; the surface of the stimulation electrode pad is provided with multiple electrode points; The control module is configured to determine multiple electrode matrices based on the multiple electrode points; The control module is further configured to apply electrical stimulation to the stimulation point using each of the plurality of electrode matrices; The detection module is configured to collect the electrophysiological response corresponding to each of the plurality of electrode matrices; the electrophysiological response is the physiological response information caused by electrical stimulation when each of the plurality of electrode matrices is used to electrically stimulate the stimulation point; The control module is further configured to determine the optimal electrode matrix from the plurality of electrode matrices based on the electrophysiological response; The control module is also configured to apply electrical stimulation to the stimulation point using the optimal electrode matrix.

2. The electrical stimulation system according to claim 1, wherein, The electrophysiological response includes one or more of the following information: Information includes compound action potentials, electromyographic signals, local blood flow, muscle spatial displacement, and heart rate.

3. The electrical stimulation method according to claim 1, wherein, Also includes: The control module is further configured to determine one or more electrode matrix combinations based on the electrode points of the optimal electrode matrix; the electrode matrix combination includes multiple electrode matrices. The control module is further configured to perform electrical stimulation using a first electrode matrix combination; the first electrode matrix combination is an electrode matrix combination selected by the user from one or more electrode matrix combinations.

4. The electrical stimulation system according to claim 1, wherein, The control module is further configured to use each of the plurality of electrode matrices to electrically stimulate the stimulation point with an electrical stimulation signal of the first intensity. The detection module is configured to collect the electrophysiological response corresponding to each of the plurality of electrode matrices; The control module is further configured to score each electrode matrix among the plurality of electrode matrices based on the electrophysiological response, and determine the electrode matrix with the best score as the optimal electrode matrix.

5. The electrical stimulation system according to claim 4, wherein, The control module is further configured to obtain a scoring queue based on the scores of each electrode matrix in the plurality of electrode matrices; The control module is also configured to detect whether each electrode point in the optimal electrode matrix is ​​normal; The control module is further configured to remove abnormal electrode points from the optimal electrode matrix if there are abnormal electrode points in the optimal electrode matrix, thereby obtaining a first electrode matrix. The control module is also configured to redetermine the optimal electrode matrix based on the scoring queue and the first electrode matrix.

6. The electrical stimulation system according to claim 4, wherein, The control module is further configured to preprocess the electrophysiological response, extract features from the preprocessed electrophysiological response, and obtain the physiological response features corresponding to the electrophysiological response. The control module is also configured to score each electrode matrix among the plurality of electrode matrices based on the physiological response characteristics.

7. The electrical stimulation system according to claim 1, wherein, The detection module is also configured to collect electrophysiological responses during the electrical stimulation process; The control module is also configured to analyze the electrophysiological response to obtain treatment parameters. number; The electrical stimulation system further includes: a display module and / or a terminal APP; wherein... The display module is configured to visualize the treatment parameters; The terminal APP is configured to visualize the treatment parameters.

8. The electrical stimulation system according to claim 1, wherein, The electrical stimulation system further includes: a physical button module and / or a terminal APP; wherein... The physical button module is configured to receive a first operation, wherein the first operation is an operation by which the user adjusts the intensity of electrical stimulation; and / or, the terminal APP is configured to receive a first operation, wherein the first operation is an operation by which the user adjusts the intensity of electrical stimulation. The control module is also configured to adjust the intensity of electrical stimulation based on the first operation.

9. The electrical stimulation system according to claim 1, wherein, The control module is also configured to stop electrical stimulation when the electrical stimulation time reaches a predetermined time.

10. The electrical stimulation system according to claim 1, wherein, The electrical stimulation system also includes: a terminal APP; The terminal APP is configured to receive a second operation; the second operation is the user recording first information; the first information includes: user personal information and self-monitoring data of the treatment process. The control module is further configured to generate a quality of life report based on the first information; and / or, The control module is also configured to establish a user profile based on the first information and import the optimal electrode matrix into the user profile.

11. The electrical stimulation system according to claim 1, wherein, The control module includes: a stimulation circuit; the stimulation circuit is configured to generate a pulse signal with a curved envelope as an electrical stimulation signal; the electrical stimulation signal is used for electrical stimulation.

12. The electrical stimulation system according to claim 11, wherein, The stimulation circuit includes: a constant current module, a microcontroller (MCU), and an H-bridge circuit; wherein... The constant current module is connected to the H-bridge circuit and is configured to provide current to the H-bridge circuit. The MCU is connected to the H-bridge circuit and configured to send a control signal to the H-bridge circuit, the control signal being used to control the H-bridge circuit to generate the electrical stimulation signal.

13. The tibial nerve electrical stimulation system according to claim 12, wherein, The stimulation circuit also includes: a sampling module; The sampling module is connected to the H-bridge circuit and the MCU, and is configured to collect the operating parameters of the H-bridge circuit, obtain a sampling signal, and send the sampling signal to the MCU; The MCU is configured to receive the sampling signal and adjust the control signal according to the sampling signal.

14. The electrical stimulation system according to claim 12 or 13, wherein, The stimulation circuit also includes a boost module; the boost module is connected to the H-bridge circuit and is configured to enhance the intensity of the electrical stimulation signal.

Images