A closed-loop electrical control system based on monitoring of sacral nerve electrical activity

Abstract

The present application discloses a closed-loop electrical control system based on monitoring of sacral nerve electrical activity, including: an implantable neural control module, a program control module and a server module; through the implantable neural control module, monitoring data is obtained according to the implanted electrodes, and the local field potential change signal generated by the sacral nerve conduction of patients with urinary tract dysfunction is monitored at the same time; when the abnormal monitoring result of the neural afferent impulse related to the patient's urgency symptom is obtained according to the local field potential change signal, an electrical stimulation pulse is applied to the patient's sacral nerve; through the server module, the monitoring data is stored, and a pre-trained intelligent recognition model is sent to the implantable neural control module and the program control module respectively. On the one hand, the present application realizes real-time monitoring of the sacral nerve and can automatically identify abnormal reflex signals of the sacral nerve. On the other hand, it realizes the automated control of the sacral nerve and can automatically apply electrical stimulation for intervention to form a complete closed-loop control and improve the accuracy and effectiveness of treatment.

Description

Technical Field

[0001] The present application relates to the technical field of neural electrical stimulation, and in particular to a closed-loop electrical control system based on monitoring of sacral nerve electrical activity. Background Art

[0002] Sacral neuromodulation (SNM) is a neuromodulation technology that uses an implantable electrical stimulation pulse generator to continuously apply low-frequency electrical pulses to specific sacral nerves (S3, S4) through implanted electrodes to excite or inhibit neural pathways, regulate abnormal sacral nerve reflex arcs, and further affect and regulate the functions of bladder, urethral / anal sphincters, pelvic floor and other target organs controlled by sacral nerves, achieving therapeutic effects. In related technologies, the sacral nerve regulation system lacks real-time performance, and is also unable to regulate autonomously or has poor effects when manually intervened. Summary of the invention

[0003] The embodiment of the present application provides a closed-loop electrical control system based on sacral nerve electrical activity monitoring to achieve the technical effect of real-time monitoring and automatic identification of abnormal sacral nerve reflex signals, automatically applying electrical stimulation for intervention to form a complete closed-loop control, and thereby improving the effectiveness of treatment.

[0004] The present application embodiment adopts the following technical solutions:

[0005] Provided is a closed-loop electrical control system based on sacral nerve electrical activity monitoring, the system comprising: an implantable neural control module, a program control module and a server module, the implantable neural control module being connected to the program control module, the server module being connected to the program control module, the implantable neural control module being used to obtain monitoring data according to implanted electrodes, and at the same time obtaining local field potential change signals generated by sacral nerve conduction in patients with urinary tract dysfunction through monitoring;

[0006] When an abnormal monitoring result of afferent nerve impulses related to the patient's urinary urgency symptoms is obtained according to the local field potential change signal, an electrical stimulation pulse is applied to the patient's sacral nerve, wherein the control signal of the electrical stimulation pulse is generated by the program-controlled module; the server module is used to store the monitored data and send a pre-trained intelligent recognition model to the implantable neural control module and the program-controlled module respectively.

[0007] Optionally, the local field potential change signal is caused by neural activity causing urinary tract dysfunction, and the implantable neural regulation module can work offline or in cooperation with the program control module;

[0008] The implantable neural regulation module is also used to

[0009] When it is identified that the abnormal monitoring result is restored to the normal monitoring result of the patient's asymptomatic period, the electrical stimulation pulse applied to the sacral nerve is turned off in response to the normal monitoring result and according to a preset delay time.

[0010] Optionally, the implantable neural regulation module is further used to determine whether there is an abnormal monitoring result of afferent nerve impulses related to the patient's urinary urgency symptom based on the first processing result of the local field potential change signal and the intelligent recognition model, and send the monitored local field potential change signal to the program control module;

[0011] The program control module is further used to process the received local field potential change signal, and determine whether there is an abnormal monitoring result of afferent nerve impulses related to the patient's urinary urgency symptom based on the second processing result of the local field potential change signal and the intelligent recognition model;

[0012] In the presence of abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms, corresponding interactive interface information is displayed and electrical stimulation pulse parameters input by a doctor are received, so that the implantable neural regulation module applies electrical stimulation pulses to the sacral nerves.

[0013] Optionally, the implantable neural regulation module includes a first feature extraction unit and an intelligent recognition unit, wherein the first feature extraction unit is used to perform time-frequency processing on the local field potential change signal after the first filtering processing to form a two-dimensional feature matrix of time and frequency, and extract the first feature parameter and send it to the intelligent recognition unit; the intelligent recognition unit is used to identify in real time, based on an intelligent recognition model, the first feature parameter corresponding to the local field potential change signal generated by the sacral nerve conduction of a patient with understandable urinary tract dysfunction, wherein the first feature parameter includes at least one of the following: change in potential intensity, change in potential frequency; based on the first feature parameter, the first monitoring result corresponding to the local field potential change signal is judged, and in the presence of abnormal monitoring results of neural afferent impulses related to the patient's urgency symptoms, electrical stimulation pulse regulation of the sacral nerve is started.

[0014] Optionally, the program control module includes a display unit, which is used to display corresponding interactive interface information of one of the following: a local field potential change signal transmitted by the implantable neural regulation module, a second processing result and a second monitoring result of the local field potential change signal by the program control module, and a status interface of the implantable neural regulation module.

[0015] Optionally, the program control module also includes a parameter configuration unit, which is used to configure the electrical stimulation pulse parameters according to the interactive interface information of the display unit, and send the configured electrical stimulation pulse parameters to the neural stimulation unit of the implantable neural regulation module to apply electrical stimulation pulses to the sacral nerves through the electrode channel.

[0016] Optionally, the program control module includes a second feature extraction unit and an algorithm configuration unit, wherein the second feature extraction unit is used to perform time-frequency processing on the local field potential change signal after the second filtering process to form a two-dimensional feature matrix of time and frequency, and extract the second feature parameter and send it to the algorithm configuration unit; the algorithm configuration unit is used to identify in real time based on the intelligent recognition model the second feature parameter corresponding to the local field potential change signal generated by the sacral nerve conduction of the patient with urinary tract dysfunction that can be understood, wherein the second feature parameter includes at least one of the following: potential intensity change, potential frequency change;

[0017] According to the second characteristic parameter, the second monitoring result corresponding to the local field potential change signal is determined and the model parameters of the intelligent recognition model are adjusted, and the adjusted intelligent recognition model is sent to the implantable neural regulation module.

[0018] Optionally, the server module is also used to construct the intelligent recognition model, which is obtained by training with a machine learning algorithm using multiple sets of training data, and each set of data in the multiple sets of training data includes: bioelectric signals generated near the sacral nerves by patients with urinary tract dysfunction in the symptomatic and non-symptomatic stages.

[0019] Optionally, the implantable neural regulation module also includes a sacral nerve signal acquisition unit, which is used to collect and obtain in real time the local field potential change signal generated by the sacral nerve conduction of the patient with urinary tract dysfunction, and send the local field potential change signal to the first signal processing unit of the implantable neural regulation module and the second signal processing unit of the program control module respectively.

[0020] Optionally, the electrical stimulation pulse parameters contained in the parameter configuration unit include at least one of the following: amplitude, pulse width, frequency, treatment duration, variable frequency / constant frequency, high frequency, low frequency and voltage / current source.

[0021] At least one of the above technical solutions adopted in the embodiments of the present application can achieve the following beneficial effects:

[0022] Different from the problem of poor real-time performance of the collection and identification process during sacral nerve regulation in related technologies, the closed-loop electrical regulation system based on sacral nerve electrical activity monitoring in the present application obtains monitoring data and monitors the local field potential change signals generated by sacral nerve conduction in patients with urinary tract dysfunction through an implantable neural regulation module; when abnormal monitoring results of neural afferent impulses related to the patient's urgency symptoms are automatically identified, electrical stimulation pulses are applied to the patient's sacral nerves, forming a complete set of closed-loop regulation, which effectively improves the effectiveness of treatment.

[0023] Different from the manual recognition or self-supervision model methods in the related arts, which have the problem of poor recognition effect, the closed-loop electrical control system based on sacral nerve electrical activity monitoring of the present application stores the monitoring data through the server module, and sends the pre-trained intelligent recognition model to the implantable neural regulation module and the programmable module respectively. It can judge in real time whether there is any abnormality in the current neural signal, thereby improving the efficiency and accuracy of recognition.

[0024] Different from the general control method used in the related art, which lacks individual precision or has poor individual precision when performing sacral nerve control, and continuous electrical stimulation causes patient discomfort and power consumption, the closed-loop electrical control system based on sacral nerve electrical activity monitoring in the present application, through the display unit in the programmable module, displays the local field potential change signal and its monitoring results in real time, which can better help researchers or doctors to study and determine the specificity of local field potential changes in sacral nerves and the relationship between the patient's symptom stage; more importantly, the present application can achieve on-demand stimulation, intermittent stimulation and quantitative precision stimulation based on individual bioelectric signal indicators, avoid ineffective stimulation, and extend the battery life of the electrical control system while reducing the patient's stimulation discomfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0026] Figure 1 It is a schematic diagram of the structure of a closed-loop electrical control system based on sacral nerve electrical activity monitoring in an embodiment of the present application;

[0027] Figure 2 The graph of the potential signal changes during the urgency and non-urgency periods of the patient after the electrode is implanted;

[0028] In the figure: 1. implantable neural regulation module; 2. program control module; 3. server module; 11. electrode channel; 12. sacral nerve signal acquisition unit; 13. first signal processing unit; 14. first feature extraction unit; 15. intelligent recognition unit; 16. neural stimulation unit; 21. second signal processing unit; 22. second feature extraction unit; 23. display unit; 24. parameter configuration unit; 25. algorithm configuration unit. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solution and advantages of the present application clearer, the technical solution of the present application will be clearly and completely described below in combination with the specific embodiments of the present application and the corresponding drawings. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present application.

[0030] To facilitate understanding of the technical solution of the closed-loop electrical control system based on sacral nerve electrical activity monitoring of the embodiment of the present application, the technical principle of the embodiment of the present application is first explained.

[0031] SNM can be applied to various refractory lower urinary tract dysfunctions, including refractory overactive bladder, idiopathic urinary retention, defecation dysfunction, etc. Although the regulatory effect of SNM on neural pathways has been clinically agreed upon, the mechanism of action of sacral nerves in regulating SNM still needs to be further explored, especially the relationship between the signals of sacral nerve pathways in patients with symptoms and symptoms. For example, whether the local electric field changes caused by abnormal sacral nerve reflexes on the neural pathways are specific, whether there is a strong correlation between specificity and symptomatic period, and whether the degree of field potential changes is related to the conversion rate of the first-stage in vitro experience treatment of sacral nerves and the second-stage permanent implantation, etc., are key issues that still need to be resolved; at the same time, once the relationship between the local electric field changes caused by sacral nerve reflexes in the symptomatic period and lower urinary tract dysfunction is found, and a research paradigm at the electrophysiological indication level is established, it will be able to lay a theoretical foundation for further improving the effectiveness of treatment.

[0032] Since patients will generate relevant nerve afferent impulses when they have urinary urgency symptoms, which are then transmitted from peripheral nerves to sacral nerve roots, the inventors have conducted in-depth research on the correlation between patients' urinary urgency symptoms and sacral nerve afferent impulses and local field potential changes. Figure 2 As shown, it provides a graph of the potential signal changes during the urgency and non-urgency periods after the patient has implanted the electrode. Figure 2 The left side is the collected original potential signal, with the horizontal axis representing time and the vertical axis representing voltage (mV); Figure 2 On the right is the spectrum analysis diagram corresponding to the original potential signal, with the horizontal axis representing frequency (Hz) and the vertical axis representing signal strength (dB).

[0033] After the phase I sacral nerve electrode implantation of the patient was completed, the electrode was placed next to the sacral nerve root in the S3 nerve foramen. The inventor's research work specifically includes: Through the electrode, the inventor obtained the patient's potential signal data during the urgency and non-urgency periods, and filtered and analyzed the data; the results show that: there are significant differences in the spectrum distribution of the patient's sacral nerve electrical signals during the non-urgency period and the urgency period. In the low-frequency range, such as 1-40Hz, the signal intensity in the non-urgency period is higher than that in the urgency period; and in the relatively high-frequency range, such as 100-200Hz, the signal intensity in the non-urgency period is slightly lower than that in the urgency period.

[0034] Therefore, the technical concept of the present application is to use implantable electrodes to obtain the monitoring data generated during sacral nerve conduction, monitor in real time the potential change signals generated by the sacral nerve position in patients with urinary tract dysfunction during the urgency and non-urgency periods, and analyze and identify abnormal monitoring results of nerve afferent impulses related to the patient's urgency symptoms through the specificity of the local field potential changes of the sacral nerves and the correlation between the patient's symptom period, automatically apply electrical stimulation for intervention, thereby forming a complete set of closed-loop control, realizing on-demand collection and quantitative and precise stimulation of individual bioelectric signal indicators, and improving the treatment effect.

[0035] The technical solutions provided by various embodiments of the present application are described in detail below in conjunction with the accompanying drawings.

[0036] The present application embodiment provides a closed-loop electrical control system based on sacral nerve electrical activity monitoring, such as Figure 1 As shown, a structural schematic diagram of a closed-loop electrical regulation system based on sacral nerve electrical activity monitoring is provided. The closed-loop electrical regulation system based on sacral nerve electrical activity monitoring of an embodiment of the present application includes: an implantable neural regulation module 1, a program-controlled module 2 and a server module 3, wherein the implantable neural regulation module 1 is connected to the program-controlled module 2, and the server module 3 is connected to the program-controlled module 2. The implantable neural regulation module 1 is used to obtain monitoring data related to sacral nerve conduction according to the implanted electrodes, and at the same time, obtain the local field potential change signal generated by the urinary tract dysfunction patient during sacral nerve conduction through monitoring; when an abnormal monitoring result of the presence of afferent nerve impulses related to the patient's urgency symptom is obtained according to the local field potential change signal, an electrical stimulation pulse is applied to the patient's sacral nerve, wherein the control signal of the electrical stimulation pulse is generated by the program-controlled module 2; the server module 3 is used to store the monitoring data and send a pre-trained intelligent recognition model to the implantable neural regulation module 1 and the program-controlled module 2 respectively.

[0037] Specifically, the implantable neural regulation module 1 collects and processes the local field potential change signal generated during the conduction of the sacral nerve, and sends it to the program control module 2, and the program control module 2 continues to send the local field potential change signal to the server module 3. That is to say, this embodiment monitors the bioelectric signals generated near the sacral nerve during the symptomatic and non-symptomatic periods of the patient in an implanted manner, such as monitoring the membrane potential of the patient's peripheral nerves. Afterwards, the server module 3 is used to receive the local field potential change signal transmitted by the program control module 2 to train the classifier, and then construct an intelligent recognition model, and send the constructed intelligent recognition model to the program control module 2. At this time, the program control module 2 also sends the constructed intelligent recognition model to the implantable neural regulation module 1, for example, after sending the constructed intelligent recognition model to the algorithm configuration unit 25, it is sent to the intelligent recognition unit 15.

[0038] Further, the implantable neural regulation module 1 obtains the constructed intelligent recognition model sent by the program control module 2, so as to automatically determine whether there is an abnormal monitoring result of the neural afferent impulse related to the patient's urinary urgency symptoms according to its signal processing results and the constructed intelligent recognition model; the implantable neural regulation module 1 transmits the collected local field potential change signal to the program control module 2, and obtains the electrical stimulation pulse parameters generated by the program control module 2, that is, the control signal of the electrical stimulation pulse is sent by the program control module 2; when there is an abnormal monitoring result of the neural afferent impulse related to the patient's urinary urgency symptoms, the electrical stimulation pulse function is turned on, and the electrical stimulation pulse is applied to the sacral nerve according to the electrical stimulation pulse parameters. It can be understood that the electrical stimulation pulse parameters in the embodiment of the present application can be standardized treatment parameters pre-stored in the parameter configuration unit 24, or can be treatment parameters automatically generated by a pre-established machine learning model based on the interception data, or can be electrical stimulation pulse parameters that are comprehensively judged and set by the doctor according to the interactive interface information of the display unit 23, which is not limited here.

[0039] It can be seen that the closed-loop electrical control system based on sacral nerve electrical activity monitoring of the embodiment of the present application can collect, monitor and automatically identify the local field potential change signals generated by the patient's sacral nerve conduction in real time, and automatically apply electrical stimulation to intervene when abnormal electrical signals are present, thereby forming a complete set of closed-loop control, effectively improving the accuracy of system recognition, and realizing on-demand collection and quantitative and precise stimulation based on individual bioelectric signal indications, further improving the treatment ability and treatment effect; at the same time, since the implantable neural control module 1 needs to be implanted in the patient's body, the on-demand stimulation, intermittent stimulation and quantitative and precise stimulation functions involved in this application can effectively reduce the discomfort caused by electrical stimulation to the patient, and extend the battery life of the electrical control system, without the need for frequent replacement of implanted equipment, thereby improving the patient's treatment experience.

[0040] It should be noted that this application is particularly suitable for monitoring, symptom identification, evaluation and electrical stimulation pulse treatment of OAB patients (overactive bladder patients). Of course, the technical solution of this application can also be extended to the monitoring and treatment of other urinary tract dysfunction symptoms, which is not limited here.

[0041] In some embodiments, the implantable neural control module 1, the program control module 2 and the server module 3 are all equipped with a built-in communication unit. Preferably, the implantable neural control module 1 and the program control module 2 communicate wirelessly, and the program control module 2 and the server module 3 communicate via the Internet, thereby minimizing the restrictions on the patient's activities when worn. Of course, the closed-loop electrical control system based on sacral nerve electrical activity monitoring in this embodiment can also communicate in other wired or wireless ways, which is not limited here.

[0042] In some embodiments of the present application, the local field potential change signal is caused by neural activity that causes urinary tract dysfunction, and the implantable neural regulation module 1 can work offline or cooperate with the program control module 2.

[0043] The implantable neuroregulatory module 1 is also used to respond to the normal monitoring result and turn off the electrical stimulation pulse applied to the sacral nerve according to the preset delay time when it is identified that the abnormal monitoring result is restored to the normal monitoring result of the patient in the non-symptomatic period. That is, when the abnormal monitoring result is identified, the sacral nerve electrical stimulation pulse is automatically turned on by the implantable neuroregulatory module 1, and then when the abnormal monitoring result is restored to the normal monitoring result, the sacral nerve electrical stimulation pulse is automatically turned off by the implantable neuroregulatory module 1; of course, a delay time can be set when turning off the sacral nerve electrical stimulation pulse to realize the delayed closing function of the electrical stimulation regulation, thereby ensuring the electrical stimulation treatment effect.

[0044] In this embodiment, the abnormal monitoring results of the neural afferent impulses related to the patient's urinary urgency symptoms are generally caused by the neural activity that causes abnormal activity of the lower urinary tract. This neural activity can be intervened by applying electrical stimulation pulses, so that the entire pelvic floor sacral neural network can be restored to balance and have a therapeutic effect. For example, after analyzing the sacral nerve data of a group of patients, it was found that when the patient felt an urgency to urinate, the processed potential change signal would show a slight increase in signal strength in the frequency band of 80-120Hz. Based on this point, a feasible implementation method is to compare the baseline strength with the real-time signal strength. When the signal strength increases, it is considered that there is an abnormal monitoring result of the neural afferent impulse related to the patient's urinary urgency symptoms, and the electrical stimulation function is activated. Of course, the above implementation is only for the convenience of understanding and simplified description, and is not a limitation to this application.

[0045] At the same time, the implantable neuroregulatory module 1 of this embodiment can work offline or in cooperation with the program control module 2. For example, when working offline, the standardized treatment parameters corresponding to the relevant symptoms are pre-stored in the implantable neuroregulatory module 1, and the sacral nerve electrical stimulation pulses are regulated by the pre-stored information; for another example, when working in cooperation, the treatment parameters input by the doctor can be sent to the implantable neuroregulatory module 1 through the program control module 2, thereby achieving quantitative and precise stimulation, which is more personalized and intelligent, and further improves the treatment ability and treatment effect.

[0046] In some embodiments of the present application, the implantable neural regulation module 1 is also used to determine whether there are abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms based on the first processing result of the local field potential change signal and the intelligent recognition model, and send the monitored local field potential change signal to the program control module 2; the program control module 2 is also used to process the received local field potential change signal, and determine whether there are abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms based on the second processing result of the local field potential change signal and the intelligent recognition model; in the case of abnormal monitoring results, the corresponding interactive interface information is displayed and the electrical stimulation pulse parameters input by the doctor are received, so that the implantable neural regulation module 1 applies electrical stimulation pulses to the sacral nerves.

[0047] That is to say, both the implantable neural regulation module 1 and the program control module 2 can process the collected original signal data and obtain the processing results and judgment results respectively. Such a design not only ensures the offline use of the implantable neural regulation module 1, but also improves the computing power and operation speed of the system. For example, the implantable neural regulation module 1 can only process the real-time data of the patient each time or a monitoring stage, and the summarized original signal data and its processing results, judgment results, etc. are displayed through the program control module 2 for the doctor's reference, and the above data are sent to the server module 3 to store and update the model parameters.

[0048] In some embodiments of the present application, the implantable neural regulation module 1 also includes a sacral nerve signal acquisition unit 12, which is used to collect and obtain in real time the local field potential change signal generated by the urinary tract dysfunction patient during sacral nerve conduction, and send the local field potential change signal to the first signal processing unit 13 of the implantable neural regulation module 1 and the second signal processing unit 21 of the programming module 2 respectively.

[0049] In some preferred embodiments of the present application, the implantable neural regulation module 1 includes a first feature extraction unit 14 and an intelligent recognition unit 15, wherein the first feature extraction unit 14 is used to perform time-frequency processing on the local field potential change signal after the first filtering processing to form a two-dimensional feature matrix of time and frequency, and extract the first feature parameter and send it to the intelligent recognition unit 15; the intelligent recognition unit 15 is used to identify in real time, based on an intelligent recognition model, the first feature parameter corresponding to the local field potential change signal generated by the sacral nerve conduction of a patient with understandable urinary tract dysfunction, wherein the first feature parameter includes at least one of the following: change in potential intensity, change in potential frequency; based on the first feature parameter, the first monitoring result corresponding to the local field potential change signal is judged, and in the presence of abnormal monitoring results of neural afferent impulses related to the patient's urgency symptoms, electrical stimulation pulse regulation is started on the sacral nerve.

[0050] Specifically, refer to Figure 1 As shown, the implantable neural regulation module 1 includes an electrode channel 11, a sacral nerve signal acquisition unit 12, a first signal processing unit 13, a first feature extraction unit 14, an intelligent recognition unit 15 and a neural stimulation unit 16 connected in sequence. The neural stimulation unit 16 is also connected to the electrode channel 11 for applying electrical stimulation pulses. The sacral nerve signal acquisition unit 12 is used to collect the local field potential change signal generated during sacral nerve conduction and transmit it to the first signal processing unit 13; the first signal processing unit 13 performs filtering processing on the local field potential change signal and sends it to the first feature extraction unit 14. The filtering process mainly removes noise and frequency signals that are not related to nerve transmission. Since the field potential around the nerve is formed by a large number of nerve fibers, it will appear as a relatively high-frequency signal. Therefore, after filtering processing, fixed frequency or lower frequency signals related to breathing, heartbeat and intestinal peristalsis can be better removed, while retaining signals related to nerve conduction. The nerve conduction signal refers to the field point position formed when the action potential propagates in the axon. Afterwards, the first feature extraction unit 14 performs time-frequency processing on the filtered signal, extracts features of the signal strength based on unit time and segmented frequency, forms a two-dimensional feature matrix composed of time and frequency, and extracts the first feature parameter and sends it to the intelligent recognition unit 15. The first feature parameter refers to a feature parameter that can reflect the change in signal potential strength and / or potential frequency. The first feature parameter can be analyzed and identified using an intelligent recognition model to determine whether the signal is abnormal. Of course, the type of the feature parameter can be set according to actual conditions and is not limited here.

[0051] That is to say, the intelligent recognition unit 15 determines in real time whether there are abnormal monitoring results of afferent nerve impulses related to the patient's urgency symptoms in the current neural signal based on the received first characteristic parameter and the constructed intelligent recognition model, for example, the first characteristic parameter is input into the constructed intelligent recognition model, and then the intelligent recognition model outputs whether there are abnormal monitoring results of afferent nerve impulses related to the patient's urgency symptoms. When there are abnormal monitoring results, a command is sent to the neural stimulation unit 16, and the neural stimulation unit 16 applies an electrical stimulation pulse to the sacral nerve through the electrode channel 11 according to the electrical stimulation pulse parameters configured by the program control module 2, and turns on the sacral nerve regulation.

[0052] Furthermore, the program control module 2 also includes a parameter configuration unit 24, which is used to configure the electrical stimulation pulse parameters according to the interactive interface information of the display unit 23, and send the configured electrical stimulation pulse parameters to the neural stimulation unit 16 of the implantable neural regulation module 1 to apply electrical stimulation pulses to the sacral nerve through the electrode channel 11.

[0053] In some embodiments, the program-controlled module 2 includes a second feature extraction unit 22 and an algorithm configuration unit 25, wherein the second feature extraction unit 22 is used to perform time-frequency processing on the local field potential change signal after the second filtering processing to form a two-dimensional feature matrix of time and frequency, and extract the second feature parameter and send it to the algorithm configuration unit 25; the algorithm configuration unit 25 is used to identify in real time, based on an intelligent recognition model, the second feature parameter corresponding to the local field potential change signal generated by the sacral nerve conduction of patients with understandable urinary tract dysfunction, wherein the second feature parameter includes at least one of the following: change in potential intensity, change in potential frequency; based on the second feature parameter, the second monitoring result corresponding to the local field potential change signal is judged and the model parameters of the intelligent recognition model are adjusted, and the adjusted intelligent recognition model is sent to the implantable neural regulation module 1.

[0054] Specifically, continue to refer to Figure 1As shown, the program control module 2 is used to receive the local field potential change signal and perform signal processing, and at the same time obtain the constructed intelligent recognition model sent by the server module 3; determine whether there is an abnormal monitoring result of the nerve afferent impulse related to the patient's urinary urgency symptoms according to the processed local field potential change signal and the constructed intelligent recognition model; when there is an abnormal monitoring result of the nerve afferent impulse related to the patient's urinary urgency symptoms, generate electrical stimulation pulse parameters. Further, the program control module 2 includes a second signal processing unit 21, a second feature extraction unit 22, an algorithm configuration unit 25, a display unit 23 and a parameter configuration unit 24. The second signal processing unit 21 receives the collected local field potential change signal and performs filtering processing on it, and then sends it to the second feature extraction unit 22; the second feature extraction unit 22 performs time-frequency processing on the filtered signal, extracts the signal strength with unit time (minute hand) and segmented frequency (frequency division), forms a two-dimensional feature matrix with time and frequency, and extracts the second feature parameter. The algorithm configuration unit 25 receives the second characteristic parameter extracted by the second characteristic extraction unit, obtains and stores the constructed intelligent recognition model sent by the server module 3; the second characteristic parameter is identified according to the constructed intelligent recognition model, and it is determined whether there is an abnormal monitoring result of the afferent nerve impulse related to the patient's urgency symptom. The display unit 23 is used to display the time-frequency information processed by the second characteristic extraction unit 22, and the time-frequency information includes but is not limited to the time-frequency diagram. When there is an abnormal monitoring result of the afferent nerve impulse related to the patient's urgency symptom, the abnormal information is displayed by the display unit 23, and specifically, it can be marked in the time-frequency diagram for the doctor to consult. Furthermore, the first characteristic parameter is generally the same as the second characteristic parameter. At the same time, the data processing steps such as signal analysis and feature extraction of the implantable neural regulation module 1 and the program-controlled module 2 are similar, and will not be repeated here.

[0055] In some embodiments of the present application, the display unit 23 is used to display corresponding interactive interface information of one of the following: the local field potential change signal transmitted by the implantable neural regulation module 1, the second processing result and the second monitoring result of the local field potential change signal by the program control module 2, and the status interface of the implantable neural regulation module 1.

[0056] For example, the interactive interface of the display unit 23 specifically includes at least one of the local field potential change signal transmitted by the implantable neural regulation module 1, the calculation and processing results and judgment results of the signal by the second feature extraction unit 22 and the algorithm configuration unit 25, the intelligent recognition model selection interface of the algorithm configuration unit 25, the electrical stimulation parameter selection interface of the parameter configuration unit 24, and the state interface of the implantable neural regulation module 1. The display unit 23 is mainly used to assist other units to interact with doctors. For example, doctors can select intelligent recognition models and adjust model parameters through the algorithm configuration unit 25, and input personalized treatment parameters (electrical stimulation pulse parameters) for the patient through the parameter configuration unit 24.

[0057] That is to say, the display unit 23 can display the processing results of signal acquisition, processing and feature extraction, as well as the comprehensive judgment results of the intelligent recognition model in real time according to the needs of the user, for reference by professionals, so as to adjust the treatment parameters efficiently and accurately. The adjusted treatment parameters and intelligent recognition model can be sent to the implantable neural regulation module 1 through the parameter configuration unit 24 and the algorithm configuration unit 25 respectively. At the same time, when there are abnormal monitoring results of neural afferent impulses related to the patient's urgency symptoms, the doctor can make a judgment based on the interactive interface information of the display unit 23, and manually configure the electrical stimulation pulse parameters through the parameter configuration unit 24, and send them to the neural stimulation unit 16 of the implantable neural regulation module 1, so that the implantable neural regulation module 1 applies the corresponding electrical stimulation pulse according to the configured electrical stimulation pulse parameters.

[0058] Preferably, the electrical stimulation pulse parameters included in the parameter configuration unit 24 include at least one of the following: amplitude, pulse width, frequency, treatment duration, variable frequency / constant frequency, high frequency, low frequency, and voltage / current source. In addition, when used offline, the sacral nerve electrical stimulation pulse parameters can be preset, for example, the stimulation intensity is determined according to the patient's typical movements, sensory responses, and pre-wearing effects during the experience period, for example, the frequency is generally set to 14 Hz and the pulse width is 210 us, which is not limited here.

[0059] In some embodiments of the present application, the server module 3 is also used to construct the intelligent recognition model, which is obtained by training with a machine learning algorithm using multiple sets of training data, and each set of data in the multiple sets of training data includes: bioelectric signals generated near the sacral nerves by patients with urinary tract dysfunction in the symptomatic and non-symptomatic stages.

[0060] Specifically, in the model training stage, the classifier is trained based on the machine learning model and the intercepted data stored on the server module 3 as the training set. The intercepted data includes the bioelectric signals near the sacral nerves in the symptomatic and non-symptomatic periods; the training process also includes: through denoising, bandpass filtering and amplification, only the signals related to nerve conduction are retained, and then the signals are subjected to time-frequency analysis, and the signal strength is extracted in time units and different frequency bands to obtain the two-dimensional feature parameters V= of the entire signal. , where i represents the dimension of time resolution in the time domain, and j represents the dimension of frequency resolution in the frequency domain; divide the set V into several small sets with equal rows and columns, that is, V= ,in ; The above several small sets constitute a training sample set, which is used to train classifiers such as convolutional neural networks or graph neural networks.

[0061] For example, the dependent variable of training a convolutional neural network can be the signal of a patient's urinary urgency attack, and the purpose is to use the model to predict the signal changes during urinary urgency attacks. The two-dimensional feature matrix obtained after time-frequency analysis can reflect the neural signal characteristics in the current time window. The two-dimensional feature matrix is ​​also a time-frequency graph. Since convolutional neural networks or graph neural networks have good recognition effects in image feature extraction, such a design is more conducive to identifying effective neural signals.

[0062] Taking the dimension of typical graphics processing 2048*2048 (i.e., i=j=2048) as an example, the dimension of the subset is set to 256*256. When there is no overlap of subset data, k=i / m=8, l=j / n=8; where i, j, k, and n are all integers. Thus, by training the configured classifier with the received local field potential change signal, and sending the updated and iteratively constructed intelligent recognition model to the program control module 2, it is possible to determine in real time whether the current neural signal is abnormal, which not only improves the accuracy of model training, but also realizes personalized treatment for patients. For example, when training a classifier, its input is the received listening data, and its output is the recognition result of the abnormal monitoring result with a classification label.

[0063] Of course, the above contents regarding the training process of the intelligent recognition model, the type of classifier, etc. are only exemplary descriptions and cannot be understood as limitations on the present application.

[0064] From the above, it can be seen that the control process of the closed-loop electrical control system based on sacral nerve electrical activity monitoring in the embodiment of the present application is as follows:

[0065] First, the local field potential change signal generated during sacral nerve conduction is collected and processed by the implantable neural control module 1, and sent to the program control module 2, which continues to send the local field potential change signal to the server module 3; secondly, the server module 3 performs classifier training on the received signal, and sends the constructed intelligent recognition model to the program control module 2 and the implantable neural control module 1; after that, the implantable neural control module 1 determines whether there are abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms based on the processing results of the local field potential change signal and the constructed intelligent recognition model. When there are abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms, electrical stimulation intervention is performed. At the same time, the program control module 2 also determines whether there are abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms based on the processing results of the local field potential change signal and the constructed intelligent recognition model. When there are abnormal monitoring results of neural afferent impulses related to the patient's urgency symptoms, the display unit 23 of the programmable module 2 displays the corresponding interactive interface information; finally, according to the pre-stored standardized treatment parameters, or the automatically generated electrical stimulation pulse parameters, or the doctor comprehensively judges and sets the electrical stimulation pulse parameters based on the interactive interface information of the display unit 23, the implantable neural regulation module 1 receives the above-mentioned electrical stimulation pulse parameters, and performs electrical stimulation intervention according to the electrical stimulation pulse parameters.

[0066] In summary, this application has achieved at least the following technical effects:

[0067] First, the closed-loop electrical control system based on sacral nerve electrical activity monitoring in the embodiment of the present application collects the local field potential change signal generated during sacral nerve conduction, and automatically identifies the signal while performing real-time monitoring; if potential abnormal electrical signals causing symptoms are found, electrical stimulation is automatically applied for intervention, thereby forming a complete set of closed-loop control to effectively improve the effectiveness of treatment.

[0068] Second, the closed-loop electrical control system based on sacral nerve electrical activity monitoring in the embodiment of the present application stores the monitoring data through the server module, and trains the configured classifier through the received local field potential change signal. After that, the updated and iterative constructed intelligent recognition model is sent to the program control module, which can determine in real time whether there is any abnormality in the current neural signal, thereby improving the efficiency and accuracy of recognition.

[0069] Third, the closed-loop electrical control system based on sacral nerve electrical activity monitoring in the embodiment of the present application can better help researchers or doctors explore the relationship between the specificity of sacral nerve local field potential changes and the patient's symptom stage by setting a display unit, and realize on-demand collection and quantitative precise stimulation based on individual bioelectric signal indicators.

[0070] It should be noted that in this application, unless otherwise clearly specified and limited, the terms such as "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0071] It should also be noted that the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, commodity or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, commodity or device. In the absence of more restrictions, the elements defined by the sentence "comprises a ..." do not exclude the existence of other identical elements in the process, method, commodity or device including the elements.

[0072] The above is only an embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A closed-loop electrical control system based on sacral nerve electrical activity monitoring, wherein: The system comprises: an implantable neural regulation module, a program control module and a server module, wherein the implantable neural regulation module is connected to the program control module, and the server module is connected to the program control module. The implantable neural regulation module is used to Acquiring the interception data generated during sacral nerve conduction according to the implanted electrodes, and obtaining the local field potential change signal generated during sacral nerve conduction in patients with urinary tract dysfunction through monitoring; the local field potential change signal is caused by the neural activity that causes urinary tract dysfunction; When an abnormal monitoring result of afferent nerve impulses related to the patient's urinary urgency symptom is obtained according to the local field potential change signal, applying an electrical stimulation pulse to the patient's sacral nerve, wherein the control signal of the electrical stimulation pulse is generated by the program control module; When it is identified that the abnormal monitoring result is restored to a normal monitoring result of the patient in the asymptomatic period, in response to the normal monitoring result and according to a preset delay time, the electrical stimulation pulse applied to the sacral nerve is turned off; The server module is used to storing the intercepted data, and sending a pre-trained intelligent recognition model to the implantable neural regulation module and the program control module respectively; The implantable neural regulation module includes an intelligent recognition unit, The intelligent recognition unit is used to Based on the intelligent recognition model, the first characteristic parameter corresponding to the local field potential change signal generated by the sacral nerve conduction of the patient with urinary tract dysfunction that can be understood is recognized in real time, and the first characteristic parameter includes at least one of the following: potential intensity change, potential frequency change; The first monitoring result corresponding to the local field potential change signal is determined based on the first characteristic parameter, and electrical stimulation pulse regulation of the sacral nerve is initiated in the presence of abnormal monitoring results of afferent nerve impulses related to the patient's urinary urgency symptom.

2. The system of claim 1, wherein: The implantable neural regulation module can work offline or in cooperation with the program control module.

3. The system of claim 1, wherein: The implantable neural regulation module is also used to According to the first processing result of the local field potential change signal and the intelligent recognition model, determining whether there is an abnormal monitoring result of afferent nerve impulses related to the patient's urinary urgency symptom, and sending the monitored local field potential change signal to the program control module; The program control module is also used to Processing the received local field potential change signal, and judging whether there is an abnormal monitoring result of afferent nerve impulses related to the patient's urinary urgency symptom according to the second processing result of the local field potential change signal and the intelligent recognition model; In the presence of abnormal monitoring results of neural afferent impulses related to the patient's urinary urgency symptoms, corresponding interactive interface information is displayed and electrical stimulation pulse parameters input by a doctor are received, so that the implantable neural regulation module applies electrical stimulation pulses to the sacral nerves.

4. The system of claim 3, wherein: The implantable neural regulation module further includes a first feature extraction unit, The first feature extraction unit is used to The local field potential change signal after the first filtering process is subjected to time-frequency processing to form a two-dimensional feature matrix of time and frequency, and the first feature parameter is extracted and sent to the intelligent recognition unit.

5. The system of claim 4, wherein: The program control module includes a display unit, which is used to Display corresponding interactive interface information of one of the following: the local field potential change signal transmitted by the implantable neural regulation module, the second processing result and the second monitoring result of the local field potential change signal by the program control module, and the status interface of the implantable neural regulation module.

6. The system of claim 5, wherein: The program control module also includes a parameter configuration unit. The parameter configuration unit is used to The electrical stimulation pulse parameters are configured according to the interactive interface information of the display unit, and the configured electrical stimulation pulse parameters are sent to the neural stimulation unit of the implantable neural regulation module to apply electrical stimulation pulses to the sacral nerves through electrode channels.

7. The system of claim 3, wherein: The program control module includes a second feature extraction unit and an algorithm configuration unit, The second feature extraction unit is used to Performing time-frequency processing on the local field potential change signal after the second filtering process to form a two-dimensional feature matrix of time and frequency, and extracting the second feature parameter and sending it to the algorithm configuration unit; The algorithm configuration unit is used to Based on the intelligent recognition model, a second characteristic parameter corresponding to the local field potential change signal generated by the sacral nerve conduction of the patient with urinary tract dysfunction that can be understood is recognized in real time, and the second characteristic parameter includes at least one of the following: potential intensity change, potential frequency change; According to the second characteristic parameter, the second monitoring result corresponding to the local field potential change signal is determined and the model parameters of the intelligent recognition model are adjusted, and the adjusted intelligent recognition model is sent to the implantable neural regulation module.

8. The system of claim 1, wherein: The server module is also used to The intelligent recognition model is constructed by using multiple sets of training data and trained by a machine learning algorithm, wherein each set of data in the multiple sets of training data includes: bioelectric signals generated near the sacral nerves of patients with urinary tract dysfunction in the symptomatic and non-symptomatic stages.

9. The system of claim 1, wherein: The implantable neural regulation module also includes a sacral nerve signal acquisition unit, which is used to The local field potential change signal generated by the urinary tract dysfunction patient during sacral nerve conduction is collected and obtained in real time, and the local field potential change signal is sent to the first signal processing unit of the implantable neural regulation module and the second signal processing unit of the program control module respectively.

10. The system of claim 6, wherein: The electrical stimulation pulse parameters contained in the parameter configuration unit include at least one of the following: amplitude, pulse width, frequency, treatment duration, variable frequency / constant frequency, high frequency, low frequency and voltage / current source.

Images