Electrode degradation detection method and system

Abstract

This disclosure provides an electrode degradation detection method and system, relating to the field of electrical stimulation technology. The method includes: determining, without using electrode contacts, initial physical efficacy parameters of the electrode contacts, initial neural response parameters of the subject under stimulation by the electrode contacts, and initial autonomic electromyography (EMG) parameters of the subject; after using the electrode contacts for a preset duration, determining current physical efficacy parameters of the electrode contacts, current neural response parameters of the subject under stimulation by the electrode contacts, and current autonomic EMG parameters of the subject; and determining whether the electrode contacts have degenerated based on at least one of the following: the difference between the current physical efficacy parameters and the initial physical efficacy parameters, the difference between the current neural response parameters and the initial neural response parameters, and the difference between the current autonomic EMG parameters and the initial autonomic EMG parameters.

Description

Technical Field

[0001] This disclosure relates to the field of electrical stimulation technology, and more specifically, to a method and system for detecting electrode degradation. Background Technology

[0002] Spinal cord electrical stimulation, as a neuromodulation technique, promotes the excitability of motor neurons by applying electrical stimulation to specific segments of the spinal cord, stimulates or enhances the contraction of target muscles, and can even awaken potential motor functions below the level of spinal cord injury to a certain extent, thus providing a possibility for the reconstruction of motor function in patients with spinal cord injury.

[0003] However, in related technologies, the electrode contacts used for spinal cord electrical stimulation may degenerate. Electrode contact degeneration and increased neural activity may occur simultaneously. Both electrode contact degeneration and increased neural activity can cause impedance changes, making it impossible to accurately detect whether the electrode has degenerated. Summary of the Invention

[0004] This disclosure provides an electrode degradation detection method, system, computer-readable storage medium, and computer program product to improve the accuracy of electrode degradation detection.

[0005] According to one aspect of the present disclosure, an electrode degradation detection method is provided, comprising: determining, without using an electrode contact, an initial physical efficacy parameter of the electrode contact, an initial neural response parameter of a subject under stimulation by the electrode contact, and an initial autonomic electromyography (EMG) parameter of the subject; after using the electrode contact for a preset duration, determining the current physical efficacy parameter of the electrode contact, the current neural response parameter of the subject under stimulation by the electrode contact, and the current autonomic EMG parameter of the subject; and determining whether the electrode contact has degraded based on at least one of the following: the difference between the current physical efficacy parameter and the initial physical efficacy parameter, the difference between the current neural response parameter and the initial neural response parameter, and the difference between the current autonomic EMG parameter and the initial autonomic EMG parameter.

[0006] According to another aspect of the present disclosure, an electrode degradation detection system is provided, comprising: an acquisition module, configured to determine, without using the electrode contact, an initial physical efficacy parameter of the electrode contact, an initial neural response parameter of a subject under stimulation by the electrode contact, and an initial voluntary electromyography (EMG) parameter of the subject; the acquisition module is further configured to determine, after using the electrode contact for a preset duration, a current physical efficacy parameter of the electrode contact, a current neural response parameter of the subject under stimulation by the electrode contact, and a current voluntary EMG parameter of the subject; and a processing module, configured to determine whether the electrode contact has degraded based on at least one of the following: the difference between the current physical efficacy parameter and the initial physical efficacy parameter, the difference between the current neural response parameter and the initial neural response parameter, and the difference between the current voluntary EMG parameter and the initial voluntary EMG parameter.

[0007] According to another aspect of the present disclosure, an electronic device is provided, including a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor executes the program to implement one or more of the methods described in the present disclosure.

[0008] According to another aspect of the present disclosure, a computer-readable storage medium is provided that stores a computer program thereon, which, when executed by a processor, implements one or more of the methods described in the embodiments of the present disclosure.

[0009] According to another aspect of the present disclosure, a computer program product is provided, including a computer program that, when executed by a processor, implements one or more of the methods described in the embodiments of the present disclosure.

[0010] The beneficial effects of the technical solutions provided in this disclosure are: The electrode degradation detection method provided in this embodiment uses initial physical efficacy parameters, initial neural response parameters, and initial autonomic electromyography parameters as multi-dimensional baselines. The current physical efficacy parameters, current neural response parameters, and current autonomic electromyography parameters collected after a preset time are compared with the initial physical efficacy parameters, initial neural response parameters, and initial autonomic electromyography parameters, respectively. Based on the comparison results, the method determines whether the electrode contact has degenerated from multiple dimensions, which can avoid interference caused by enhanced neural activity and improve the accuracy of electrode contact degradation determination.

[0011] Additional aspects and advantages of embodiments of this disclosure will be set forth in part in the description which follows, and will become apparent from the description or may be learned by practice of this disclosure. Attached Figure Description

[0012] To more clearly illustrate the technical solutions in the embodiments of this disclosure, the accompanying drawings used in the description of the embodiments of this disclosure will be briefly introduced below.

[0013] Figure 1 This is a schematic flowchart of an electrode degradation detection method provided in an embodiment of this disclosure; Figure 2 This is a schematic flowchart of another electrode degradation detection method provided in this embodiment of the present disclosure; Figure 3 This is a schematic diagram of the structure of an electrode degradation detection system provided in an embodiment of this disclosure; Figure 4 This is a schematic diagram of the structure of an electronic device provided in an embodiment of this disclosure. Detailed Implementation

[0014] The embodiments of this disclosure are described below with reference to the accompanying drawings. It should be understood that the embodiments described below with reference to the accompanying drawings are exemplary descriptions for explaining the technical solutions of the embodiments of this disclosure, and do not constitute a limitation on the technical solutions of the embodiments of this disclosure.

[0015] Those skilled in the art will understand that, unless specifically stated otherwise, the singular forms “a,” “an,” “the,” and “the” used herein may also include the plural forms. It should be further understood that the terms “comprising” and “including” as used in embodiments of this disclosure mean that the corresponding feature can be implemented as the presented feature, information, data, step, operation, element, and / or component, but do not exclude implementation as other features, information, data, step, operation, element, component, and / or combinations thereof supported by the art. It should be understood that when we say that an element is “connected” or “coupled” to another element, the element can be directly connected or coupled to the other element, or it can mean that the element and the other element are connected through an intermediate element. Furthermore, “connected” or “coupled” as used herein can include wireless connection or wireless coupling. The term “multiple” refers to two or more; therefore, in embodiments of this disclosure, “multiple” may also be understood as “at least two.” The term "and / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone. Additionally, the character " / ", unless otherwise specified, generally indicates that the related objects before and after it are in an "or" relationship.

[0016] To make the objectives, technical solutions, and advantages of this disclosure clearer, the embodiments of this disclosure will be described in further detail below with reference to the accompanying drawings.

[0017] This disclosure provides a method, system, computer-readable storage medium, and computer program product for detecting electrode degradation.

[0018] It is understood that the electrode degradation detection method provided in this disclosure involves determining whether the electrode contacts have degenerated based on the measured physical parameters of the electrode contacts, the neural response parameters of the subject fed back by the sensor, and the autonomic electromyography parameters fed back by the sensor, so as to realize timely detection and replacement of electrode contact degradation. Although the application scenario of this disclosure is spinal cord electrical stimulation, the technical solution of this disclosure does not involve direct limitation on treatment steps or dosage, but describes the internal workflow of a device or system and the operating logic of an automatic controller.

[0019] The following description of several exemplary embodiments illustrates the technical solutions of this disclosure and the technical effects produced by these solutions. It should be noted that the following embodiments can be referenced, learned from, or combined with each other. Identical terms, similar features, and similar implementation steps in different embodiments will not be repeated.

[0020] It should be noted that the method provided in this disclosure is a method for detecting whether electrodes used for electrical stimulation have degenerated. Its purpose is to determine whether the electrode contacts have degenerated in order to determine whether the electrode contacts need to be replaced, and it does not directly include the step of performing electrical stimulation on the patient. This method can be applied to scenarios without therapeutic purposes, such as testing and replacing electrode contacts, and acquiring and processing parameters during electrical stimulation. This disclosure does not limit the method to be used in the treatment process.

[0021] Figure 1 This is a schematic flowchart of an electrode degradation detection method provided in an embodiment of this disclosure.

[0022] like Figure 1 As shown, the method may include the following steps.

[0023] Step S101: Without using electrode contacts, determine the initial physical efficacy parameters of the electrode contacts, the initial neural response parameters of the subject under electrode contact stimulation, and the initial voluntary electromyography parameters of the subject.

[0024] In this embodiment of the disclosure, the electrode contacts can be electrode contacts for spinal cord electrical stimulation, and there can be multiple electrode contacts. The physical performance parameters of the electrode contacts are parameters that reflect the physical characteristics of the electrode tissue interface. The electrode tissue interface refers to the interface between the conductive surface of the implanted electrode and the surrounding biological tissue (such as spinal cord, nerve, brain parenchyma, muscle, or extracellular fluid).

[0025] In this embodiment of the disclosure, the test subject may be a person with a spinal cord injury. Neural response parameters refer to electrophysiological indicators collected under electrode contact stimulation. Autonomic electromyography parameters refer to the parameters of the electromyographic signals collected when the test subject actively attempts to move the target muscle without electrode contact stimulation.

[0026] In this embodiment of the disclosure, unused electrode contacts refer to contacts that have not yet been used for electrical stimulation. Unused electrode contacts can be considered as electrode contacts that have not degenerated. Parameters measured for unused electrode contacts can serve as a reference baseline for assessing whether the electrode contacts have degenerated. In the case of unused electrode contacts, the initial physical efficacy parameters of the electrode contacts and the initial neural response parameters of the subject under electrode contact stimulation can be considered as the first use of the electrode contacts. For example, electrical stimulation can be applied immediately after electrode placement to obtain the initial physical efficacy parameters and initial neural response parameters.

[0027] Step S102: After using the electrode contacts for a preset duration, determine the current physical efficacy parameters of the electrode contacts, the current neural response parameters of the subject under the stimulation of the electrode contacts, and the current voluntary electromyography parameters of the subject.

[0028] In this embodiment of the disclosure, after using the electrode contacts for a preset time, the electrode contacts may or may not degenerate. The current physical efficacy parameters, current neural response parameters, and current autonomic electromyography parameters are measured in the same way to facilitate comparison with the initial measurement values.

[0029] In this embodiment of the disclosure, the preset duration can be set according to the actual situation, such as one week, one month, etc.

[0030] Step S103, determine whether the electrode contact has degenerated based on at least one of the following: the difference between the current physical efficacy parameter and the initial physical efficacy parameter, the difference between the current neural response parameter and the initial neural response parameter, and the difference between the current voluntary electromyography parameter and the initial voluntary electromyography parameter.

[0031] In this embodiment, the initial physical efficacy parameters, initial neural response parameters, and initial autonomic electromyography parameters are used as multi-dimensional baselines. The current physical efficacy parameters, current neural response parameters, and current autonomic electromyography parameters collected after a preset duration are compared with the initial physical efficacy parameters, initial neural response parameters, and initial autonomic electromyography parameters, respectively. Based on the comparison results, it is determined from multiple dimensions whether the electrode contact has degenerated. This can avoid interference caused by enhanced neural activity and improve the accuracy of electrode contact degeneration determination.

[0032] In some embodiments, factors affecting the accuracy of electrode contact degradation detection results include the following three categories: changes in the physical state of the electrode interface, changes in the excitability of neural tissue, and the influence of the subject's own neural function recovery (rehabilitation effect). Considering these three categories is sufficient when determining the factors affecting the accuracy of electrode contact degradation detection results. Changes in the physical state of the electrode interface (such as fiber encapsulation on the electrode surface, coating peeling, reduced electrochemical activity, etc.) directly lead to increased electrode tissue interface impedance and decreased charge injection capacity; these factors pertain to changes in the properties of the electrode contact itself. Changes in the excitability of neural tissue (such as threshold drift of neurons, changes in synaptic transmission efficiency, etc.) result in weakened electromyographic responses induced under the same stimulation parameters. Although these factors manifest as reduced stimulation efficiency, their root cause is not a decline in electrode contact performance, but rather a change in the state of neural tissue. The subject's own neural function recovery (i.e., the neural rehabilitation effect) leads to enhanced autonomic electromyography, a leftward shift of the recruitment curve, or an increased saturation region. While these factors also cause changes in neural response parameters, they reflect an improvement in the subject's neural function, not electrode contact degradation. All three of the above factors may cause changes in the electrode response parameters obtained from a single measurement. If only the measurement results from a single dimension are relied upon, it will be difficult to distinguish whether the parameter changes are due to the degradation of the electrode contacts themselves, changes in the excitability of nerve tissue, or positive improvements brought about by the rehabilitation effect, which may lead to misjudgment.

[0033] Based on this, the embodiments of this disclosure determine whether electrode contacts have degenerated based on three dimensions: physical efficacy parameters, neural response parameters, and autonomic electromyography (EMG) parameters. First, physical efficacy parameters (such as electrode tissue interface impedance and charge injection capacity) directly reflect the physical and electrochemical state of the electrode contacts and are the most direct basis for judging whether the electrode has undergone physical degradation. This dimension is not sensitive to neuronal activity and can independently reflect changes in the state of the electrode interface itself. Second, neural response parameters (such as the minimum stimulation current required to induce EMG) reflect the ability of the electrode contacts to stimulate muscle contraction through neural tissue and are a functional indicator of stimulation efficiency. However, this dimension is affected by both electrode performance and neural tissue excitability, and cannot distinguish between degeneration and changes in neural excitability when used alone. Third, autonomic EMG parameters (such as autonomic EMG amplitude and the number of detected motor units) characterize the subject's active muscle activation ability under conditions independent of electrical stimulation and are independent biomarkers reflecting the neurorehabilitation effect. This dimension can be used to determine whether neurological function has undergone rehabilitative improvement, thereby eliminating the interference of the rehabilitation effect on changes in neural response parameters and avoiding misjudging neurological function improvement as electrode degeneration. By combining the above three dimensions, we can identify the physical degradation of the electrode interface itself through physical efficacy parameters, eliminate the interference of neurorehabilitation effects through autonomic electromyography parameters, and confirm the changes in stimulation efficiency through neural response parameters. This enables accurate determination of electrode contact degradation and effectively distinguishes between physical degradation, changes in neural excitability, and neurorehabilitation effects.

[0034] In some embodiments, determining whether an electrode contact has degenerated is based on at least one of the following: if the current physical efficacy parameter indicates physical degradation of the electrode interface compared to the initial physical efficacy parameter, then the electrode contact has degenerated; otherwise, if the current neural response parameter indicates a decrease in stimulation efficiency compared to the initial neural response parameter, and the current autonomic electromyography parameter has not increased compared to the initial autonomic electromyography parameter, then the electrode contact has degenerated; otherwise, the electrode contact has not degenerated, and the change in the current neural response parameter is attributed to a neurorehabilitation effect.

[0035] Specifically, first compare the current physical performance parameters with the initial physical performance parameters. If the current physical performance parameters deteriorate physically compared to the initial physical performance parameters (e.g., a significant increase in high-frequency impedance and a significant decrease in charge injection capacity), it indicates that the electrode surface has undergone physical changes such as fiber encapsulation or passivation. It can be directly determined that the electrode contact has undergone physical degradation, and there is no need to consider the neural response parameters and autonomic electromyography parameters.

[0036] Then, if the above conditions are not met (i.e., the current physical efficacy parameters do not indicate physical degradation of the electrode interface compared to the initial physical efficacy parameters), the current neural response parameters are compared with the initial neural response parameters, as well as the current autonomic electromyography (EMG) parameters and the initial autonomic EMG parameters. If the current neural response parameters indicate a decrease in stimulation efficiency compared to the initial neural response parameters (e.g., an increase in the minimum stimulation threshold for evoking EMG, a decrease in the slope of the recruitment curve), and the current autonomic EMG parameters do not show an increase compared to the initial autonomic EMG parameters (e.g., the current autonomic EMG amplitude is the same as or lower than the initial autonomic EMG amplitude), then the electrode contact is determined to have degenerated. The lack of increase in autonomic EMG indicates that no neurorehabilitation effect has been produced, thus ruling out the possibility that the change in neural response parameters is due to improvement in neural function, and the electrode contact can be determined to have degenerated.

[0037] Then, if the above conditions are not met (i.e., the current physical efficacy parameters do not indicate physical degradation of the electrode interface compared to the initial physical efficacy parameters, and the stimulation efficiency decreases while autonomic electromyography (EMG) does not increase), then the electrode contact is determined not to have degenerated. The fact that the current physical efficacy parameters do not indicate physical degradation of the electrode interface compared to the initial physical efficacy parameters indicates that the electrode has not degenerated, meaning the physical state of the electrode is normal. The fact that the stimulation efficiency decreases while autonomic EMG does not increase indicates that the stimulation efficiency has not decreased or that autonomic EMG has increased. Under the premise that the electrode's physical state is normal, the fact that the stimulation efficiency has not decreased or has even increased indicates improved nerve function; increased autonomic EMG can also indicate improved nerve function. Therefore, in this case, the observed changes in nerve response parameters can be attributed to a neurorehabilitation effect.

[0038] In some embodiments, the initial physical performance parameters include the initial charge injection capacity and the initial electrode tissue interface impedance, and the current physical performance parameters include the current charge injection capacity and the current electrode tissue interface impedance.

[0039] Specifically, charge injection capacity represents the charge injection capability, and initial charge injection capacity and current charge injection capacity represent the initial charge injection capability and current charge injection capability, respectively. The initial charge injection capacity and current charge injection capacity are measured in the same way, both obtained as follows: Within a safe voltage window, a gradually increasing constant current pulse is applied to the electrode contact, and the voltage response of the electrode is recorded simultaneously. When the voltage reaches a preset upper limit, the amount of charge at this point is calculated, which is the charge injection capacity. For example, a fixed stimulation pulse width (e.g., 100 to 400 microseconds) can be used, with a fixed step size (e.g., 0.1 mA) to increase the pulse current intensity. After each pulse, the voltage change during the pulse is measured. As the current increases, the electrode voltage will increase linearly due to the interfacial impedance. When the voltage reaches a preset upper limit, the current at this point is recorded, and this current is multiplied by the fixed pulse width to obtain the charge injection capacity of the electrode contact.

[0040] Specifically, electrode-tissue interface impedance, for example, can be high-frequency impedance, which is less affected by changes in the surrounding cellular environment and serves as a stable indicator for assessing the state of the electrode surface. The initial and current electrode-tissue interface impedances are measured using the same method: electrochemical impedance spectroscopy. For instance, a sinusoidal voltage signal is applied to the electrode contact, and the response current flowing through the electrode is measured. The impedance at that frequency is calculated based on the voltage and current. Multiple frequency points are scanned within a high-frequency range (e.g., 1kHz-100kHz) to obtain a complete impedance spectrum with frequency on the horizontal axis and impedance on the vertical axis. High-frequency impedance reflects the solution resistance between the electrode and the tissue. These high-frequency parameters are sensitive to the actual surface area of ​​the electrode, the integrity of the surface coating, and the state of the wire connections, but not to neuronal activity. Therefore, they serve as a stable indicator for assessing the physical state of the electrode surface (e.g., fiber encapsulation, coating detachment).

[0041] In some embodiments, the initial neural response parameters include the initial minimum stimulation current that generates electromyography, and the current neural response parameters include the current minimum stimulation current that generates electromyography.

[0042] Specifically, the minimum stimulation current refers to the smallest stimulation current that just induces electromyography (EMG). The initial minimum stimulation current and the current minimum stimulation current are measured in the same way, both obtained through intensity-duration curves. For example, with a fixed stimulation pulse width, the stimulation current intensity is increased progressively with a fixed step size. After each stimulation, it is recorded whether a detectable EMG response is induced. The minimum current intensity that just stably induces an EMG response is recorded as the minimum stimulation current for that pulse width. Then, with a different pulse width, the above steps are repeated. The threshold current points measured under different pulse widths are plotted on a coordinate system with pulse width as the horizontal axis and current intensity as the vertical axis. Connecting these points yields the intensity-duration curve. Based on this curve, given a stimulation pulse width, the minimum stimulation current that generates EMG can be obtained.

[0043] Specifically, in some embodiments, an initial recruitment curve and a current recruitment curve can also be measured. The recruitment curve, also known as a charge-dose response curve, describes the process by which the electromyographic amplitude induced by increasing stimulus charge increases from zero to a plateau, and is used to assess the size of the pool of activatable motor neurons and neuromuscular transmission efficiency. The recruitment curve can be measured by applying progressively stronger electrical stimulation pulses to the electrodes and simultaneously recording the electromyographic response amplitude induced by each stimulation. The saturation amplitude of the recruitment curve reflects the current size of the pool of activatable motor neurons; an increase in this value can serve as evidence of neurorehabilitation effects.

[0044] In some embodiments, physical degradation includes: the current electrode tissue interface impedance increasing by a first preset percentage compared to the initial electrode tissue interface impedance, and the current charge injection capacity decreasing by a second preset percentage compared to the initial charge injection capacity.

[0045] Specifically, if the electrode interfacial impedance increases significantly (e.g., greater than 20%) and the charge injection capacity decreases significantly (e.g., decreases by 30%), it indicates that the electrode surface has undergone physical changes such as fiber encapsulation or passivation, which can be determined to meet the physical degradation criteria. In this case, the electrode contact is judged to have degraded.

[0046] In some embodiments, reduced stimulation efficiency includes: the current minimum stimulation current being higher than the initial minimum stimulation current.

[0047] Specifically, if the minimum stimulation current increases, it indicates a decrease in stimulation efficiency, meaning a larger stimulation current is needed to induce electromyography (EMG). Decreased stimulation efficiency could be due to electrode degradation or a decrease in nerve tissue excitability; a comprehensive assessment combining changes in autonomic EMG parameters is necessary.

[0048] In some embodiments, the initial voluntary electromyographic parameters include the initial detected motor unit and the initial voluntary electromyographic amplitude, and the current electromyographic parameters include the current detected motor unit and the current voluntary electromyographic amplitude.

[0049] In some embodiments, the initial voluntary electromyographic parameters and the current electromyographic parameters are detected in the same way. Specifically, without the application of electrical stimulation, electromyographic signals are collected and processed when the subject actively performs muscle activity. The collected electromyographic signals can be used to determine whether motor units are detected, the number of detected motor units, and their amplitude or envelope.

[0050] In some embodiments, no enhancement includes: the currently detected motor unit has not increased and the current voluntary electromyography amplitude is lower than or equal to the initial voluntary electromyography amplitude.

[0051] Specifically, if the currently detected motor units have not increased compared to the initial detected motor units and the current voluntary electromyography (EMG) amplitude is lower than or equal to the initial voluntary EMG amplitude, it indicates that voluntary EMG has not increased. In this case, it suggests that neural function has not improved.

[0052] In some embodiments, the method may further include: when the current voluntary electromyographic parameters are enhanced compared to the initial voluntary electromyographic parameters, outputting a neurorehabilitation effect indication, and determining that the electrode contacts have not degenerated. The enhancement includes: an increase in currently detected motor units, and / or, the current voluntary electromyographic amplitude being higher than the initial voluntary electromyographic amplitude.

[0053] Specifically, if the detected motor units increase, and / or the current voluntary electromyography (EMG) amplitude is higher than the initial voluntary EMG amplitude, it indicates that voluntary EMG has been enhanced. In this case, it suggests that neural function has improved and can provide a signal of neurorehabilitation effect.

[0054] In one example, the degradation of electrode contacts is determined in the following manner.

[0055] First, a preliminary screening of the electrode surface condition is conducted. If the high-frequency impedance increases significantly (e.g., greater than 20%) and is accompanied by a significant decrease in charge injection capacity, it indicates that the electrode surface has undergone physical changes such as fiber encapsulation or passivation, and is directly judged as physical degradation of the electrode.

[0056] Next, the changes in neural state are confirmed (using autonomic electromyography as the anchor). If the charge injection capacity decreases only slightly (indicating that the chemical state of the electrode surface is basically intact) but the stimulation threshold increases (requiring a larger current to induce electromyography, but the cause is not physical degradation of the electrode surface), the determination is made based on autonomic electromyography. If autonomic electromyography increases or new detectable motor units are added, it suggests neural function recovery and is determined as a rehabilitative change in neural function. If autonomic electromyography is consistent with or weakens from the baseline (indicating that neural function has not improved), the delivery current can be compensated by combining the rate of change of high-frequency impedance to obtain a compensated recruitment curve. For example, if the rate of change of high-frequency impedance increases by 15%, the actual current attenuation value reaching the nerve tissue can be estimated based on this rate of change. The recruitment curve is compensated based on the attenuation value, and the compensated recruitment curve can reflect the true changes in neural function. If the electrode is confirmed to be physically stable (no significant drift in high-frequency impedance) and the slope of the recruitment curve decreases while the saturation region remains unchanged, the excitability of the nerve tissue is determined to be decreased; if the high-frequency impedance has drifted significantly (including the intermediate zone below 20%), it is primarily attributed to a decrease in delivery efficiency on the electrode side, i.e., the electrode contact has degenerated.

[0057] Figure 2 This is a schematic flowchart of another electrode degradation detection method provided in this embodiment.

[0058] like Figure 2 As shown, the method may also include the following steps.

[0059] Step S201: Degraded electrode contacts are selected as electrode contacts to be replaced, and non-degraded electrode contacts are selected as candidate electrode contacts.

[0060] In some embodiments, there may be multiple electrode contacts. The above method can be used to determine whether each electrode contact is degraded. Degraded electrode contacts among the multiple electrode contacts are used as electrode contacts to be replaced, and non-degraded electrode contacts are used as candidate electrode contacts.

[0061] Understandably, degraded electrode contacts can be categorized into mildly physically degraded and severely physically degraded electrode contacts. Mildly physically degraded electrode contacts may exhibit a moderate increase in high-frequency impedance and a slight decrease in charge capacity, but still within the safety margin. Severely physically degraded electrode contacts may have either high-frequency impedance or charge capacity approaching the safety boundary. Mildly physically degraded electrode contacts can continue to be used, while severely physically degraded electrode contacts need to be replaced. The electrode contacts to be replaced mentioned above can be severely physically degraded electrode contacts.

[0062] Step S202: Based on the similarity between the activation weight matrix of the candidate electrode contact and the activation weight matrix of the electrode contact to be replaced, determine the target electrode contact from the candidate electrode contacts to replace the electrode contact to be replaced.

[0063] It should be noted that, in the embodiments of this disclosure, the step of determining the target electrode contact for replacing the electrode contact to be replaced is an algorithm-level calculation and selection step, and the output is a suggestion or control instruction (e.g., controlling the stimulator to switch to a specific contact), which itself does not include the doctor actually performing the surgical replacement operation.

[0064] In some embodiments, the activation weight matrix for each electrode contact can be preset without using the electrode contacts.

[0065] In some embodiments, for an electrode contact to be replaced, the similarity between the electrode contact to be replaced and the activation weight matrix of each candidate electrode contact can be calculated, and the candidate electrode contact with the highest similarity can be selected to replace the electrode contact to be replaced.

[0066] In some embodiments, the activation weight matrix is ​​obtained by: for each electrode contact, during the application of a test pulse with preset parameters to the electrode contact, acquiring multi-channel surface electromyography to obtain the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation center of gravity; and determining the activation weight matrix of the electrode contact for the target muscle group and adjacent muscle groups based on the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation center of gravity.

[0067] Specifically, a multi-channel surface electromyography (EMG) acquisition device can be deployed on the surface of the test subject. A set of test pulses with preset parameters is applied to each electrode contact; during the pulse application, EMG signals from all channels are simultaneously acquired. The activation amplitude (e.g., root mean square value) of each channel is obtained based on the EMG signal of each channel. Based on the activation amplitude of each channel, the activation amplitude of the target muscle group (i.e., the average activation amplitude of the channel containing the predetermined target muscle), the distribution of activated muscle groups (the spatial distribution pattern of activation amplitudes across all channels, which can be represented by a heatmap or contour map), and the centroid coordinates of activation (the spatial centroid calculated by weighting the coordinate positions of each channel with the activation amplitude, reflecting the center position of the activation area) can be calculated. Based on the activation amplitude of the target muscle group, the distribution of activated muscle groups, and the centroid coordinates of activation, an activation weight matrix is ​​constructed for each electrode contact. Each element in the matrix represents the activation weight of that electrode contact for different muscle groups (including the target muscle group and adjacent muscle groups) (e.g., the target muscle group weight is the normalized target activation amplitude, and the adjacent muscle group weight is the activation amplitude of the adjacent channel).

[0068] In some embodiments, the activation weight matrix of the electrode contacts can be used to determine the candidate electrode contacts that are closest in function to the electrode contacts to be replaced, so as to maintain the stimulation effect of the original contacts after the electrode contacts are replaced, and avoid the problem of deterioration of stimulation effect due to contact degradation.

[0069] In some embodiments, the method may further include: if the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is consistent with the initial autonomic electromyography parameter, determining the degradation type of the electrode contact as physical degradation; if the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is enhanced compared to the initial autonomic electromyography parameter, determining the degradation type of the electrode contact as mixed degradation.

[0070] In some embodiments, the type of degradation can be further determined for degraded electrode contacts. Physical degradation refers to only physical degradation of the electrode without any neurorehabilitation effect; mixed degradation refers to both physical degradation of the electrode and a neurorehabilitation effect.

[0071] For example, when high-frequency impedance increases, charge injection capacity decreases, and autonomic electromyography (EMG) is consistent with the baseline, the degradation type of the electrode contact can be determined to be physical degradation. When high-frequency impedance increases or charge injection capacity decreases, and autonomic EMG increases or the recruitment curve shifts to the left, the degradation type of the electrode contact can be determined to be mixed degradation. When high-frequency impedance and charge injection capacity are stable, but autonomic EMG increases, the recruitment curve shifts to the left, or the saturation region increases, it can be determined that the electrode contact has not degenerated, and only a neurorehabilitation effect has occurred.

[0072] In some embodiments, for degraded electrode contacts, the degradation type is further determined to be physical degradation or mixed degradation, thereby improving the accuracy of electrode contact degradation determination.

[0073] It should be noted that in the embodiments of this disclosure, "applying test pulses" and "acquiring multi-channel surface electromyography" are non-therapeutic and non-diagnostic operations used to evaluate the performance of the electrical stimulation system. Their purpose is not to diagnose the degree of nerve damage in patients, but rather to establish a performance baseline for the electrodes.

[0074] Furthermore, the method disclosed herein is a non-diagnostic, non-therapeutic method for detecting the performance of electrode contacts in an electrostimulation system. All steps involving the subject are performed under safe and standard electrostimulation system testing protocols, with the sole purpose of obtaining reference data necessary to assess the physical and electrochemical state of the electrode contacts. The final output of this method is whether the electrode contacts have degraded or require replacement; this result is not intended to directly derive any diagnostic conclusions regarding the subject's disease condition, nor does it include any steps involving treatment or surgery on the subject.

[0075] This disclosure provides an electrode degradation detection system, such as Figure 3 As shown, the system 300 includes: The acquisition module 301 is used to determine the initial physical efficacy parameters of the electrode contacts, the initial neural response parameters of the subject under the stimulation of the electrode contacts, and the initial autonomic electromyography parameters of the subject without using the electrode contacts. The acquisition module 301 is also used to determine the current physical efficacy parameters of the electrode contact, the current neural response parameters of the subject under the stimulation of the electrode contact, and the current autonomic electromyography parameters of the subject after using the electrode contact for a preset time. Processing module 302 is configured to determine whether the electrode contact is degraded based on at least one of the following: The difference between the current physical performance parameters and the initial physical performance parameters The difference between the current neural response parameters and the initial neural response parameters The difference between the current voluntary electromyography (EMG) parameters and the initial voluntary EMG parameters.

[0076] In some embodiments, the processing module is configured to: determine that the electrode contact has degenerated if the current physical efficacy parameter indicates physical degradation of the electrode interface compared to the initial physical efficacy parameter; otherwise, determine that the electrode contact has degenerated if the current neural response parameter indicates a decrease in stimulation efficiency compared to the initial neural response parameter, and the current autonomic electromyography parameter does not increase compared to the initial autonomic electromyography parameter; otherwise, determine that the electrode contact has not degenerated, and attribute the change in the current neural response parameter to a neurorehabilitation effect.

[0077] In some embodiments, the initial physical efficacy parameters include initial charge injection capacity and initial electrode tissue interface impedance, and the current physical efficacy parameters include current charge injection capacity and current electrode tissue interface impedance; the initial neural response parameters include initial minimum stimulation current for generating electromyography (EMG), and the current neural response parameters include current minimum stimulation current for generating EMG; wherein, the physical degradation includes: the current electrode tissue interface impedance increasing by a first preset percentage compared to the initial electrode tissue interface impedance, and the current charge injection capacity decreasing by a second preset percentage compared to the initial charge injection capacity; the reduction in stimulation efficiency includes: the current minimum stimulation current being higher than the initial minimum stimulation current.

[0078] In some embodiments, the initial voluntary electromyography (EMG) parameters include an initial detected motor unit and an initial voluntary EMG amplitude, and the current EMG parameters include a current detected motor unit and a current voluntary EMG amplitude; the absence of enhancement includes: the current detected motor unit has not increased and the current voluntary EMG amplitude is lower than or equal to the initial voluntary EMG amplitude; the processing module is further configured to: when the current voluntary EMG parameters are enhanced compared to the initial voluntary EMG parameters, output a neurorehabilitation effect indication, and determine that the electrode contacts have not degenerated; wherein, the enhancement includes: the current detected motor unit has increased, and / or, the current voluntary EMG amplitude is higher than the initial voluntary EMG amplitude.

[0079] In some embodiments, the processing module is further configured to: use degraded electrode contacts as electrode contacts to be replaced, and non-degraded electrode contacts as candidate electrode contacts; and determine a target electrode contact from the candidate electrode contacts to replace the electrode contacts to be replaced based on the similarity between the activation weight matrix of the candidate electrode contacts and the activation weight matrix of the electrode contacts to be replaced.

[0080] In some embodiments, the activation weight matrix is ​​obtained by: for each electrode contact, during the application of a test pulse with preset parameters to the electrode contact, acquiring multi-channel surface electromyography to obtain the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation center of gravity; and determining the activation weight matrix of the electrode contact for the target muscle group and adjacent muscle groups based on the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation center of gravity.

[0081] In some embodiments, the processing module is further configured to: if the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is consistent with the initial autonomic electromyography parameter, determine that the degradation type of the electrode contact is physical degradation; if the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is enhanced compared to the initial autonomic electromyography parameter, determine that the degradation type of the electrode contact is mixed degradation.

[0082] The apparatus or system of this disclosure can execute the methods provided in the embodiments of this disclosure, and their implementation principles are similar, and they have corresponding technical effects. The actions performed by each module in the apparatus or system of each embodiment of this disclosure correspond to the steps in the methods of each embodiment of this disclosure. For a detailed functional description of each module of the apparatus or system, please refer to the description in the corresponding method shown above, which will not be repeated here.

[0083] This disclosure provides an electronic device including a memory, a processor, and a computer program stored in the memory, wherein the processor executes the computer program to implement the steps of the method provided in any optional embodiment of this disclosure.

[0084] In an alternative embodiment, an electronic device, such as Figure 4 As shown, Figure 4 The illustrated electronic device 400 includes a processor 401 and a memory 403. The processor 401 and the memory 403 are connected, for example, via a bus 402. Optionally, the electronic device 400 may further include a transceiver 404, which can be used for data interaction between the electronic device and other electronic devices, such as sending and / or receiving data. It should be noted that in practical applications, the transceiver 404 is not limited to one type, and the structure of the electronic device 400 does not constitute a limitation on the embodiments of this disclosure.

[0085] Processor 401 may be a CPU (Central Processing Unit), a general-purpose processor, a DSP (Digital Signal Processor), an ASIC (Application Specific Integrated Circuit), an FPGA (Field Programmable Gate Array), or other programmable logic devices, transistor logic devices, hardware components, or any combination thereof. It may implement or execute the various exemplary logic blocks, modules, and circuits described in conjunction with this disclosure. Processor 401 may also be a combination that implements computational functions, such as including one or more microprocessor combinations, a combination of a DSP and a microprocessor, etc.

[0086] Bus 402 may include a pathway for transmitting information between the aforementioned components. Bus 402 may be a PCI (Peripheral Component Interconnect) bus or an EISA (Extended Industry Standard Architecture) bus, etc. Bus 402 can be divided into address bus, data bus, control bus, etc. For ease of representation, Figure 4 The bus is represented by a single thick line, but this does not mean that there is only one bus or one type of bus.

[0087] The memory 403 may be ROM (Read Only Memory) or other types of static storage devices capable of storing static information and instructions, RAM (Random Access Memory) or other types of dynamic storage devices capable of storing information and instructions, or EEPROM (Electrically Erasable Programmable Read Only Memory), CD-ROM (Compact Disc Read Only Memory) or other optical disc storage, optical disc storage (including compressed optical discs, laser discs, optical discs, digital universal optical discs, Blu-ray discs, etc.), magnetic disk storage media, other magnetic storage devices, or any other medium capable of carrying or storing computer programs and capable of being read by a computer, without limitation herein.

[0088] The memory 403 is used to store computer programs that execute embodiments of the present disclosure, and the execution is controlled by the processor 401. The processor 401 is used to execute the computer programs stored in the memory 403 to implement the steps shown in the foregoing method embodiments.

[0089] Among them, electronic devices include, but are not limited to: mobile terminals such as mobile phones, laptops, digital radio receivers, PDAs (personal digital assistants), PADs (tablet computers), PMPs (portable multimedia players), and in-vehicle terminals (such as in-vehicle navigation terminals), as well as fixed terminals such as digital TVs and desktop computers. Figure 4 The electronic device shown is merely an example and should not be construed as limiting the functionality and scope of the embodiments disclosed herein.

[0090] This disclosure provides a computer-readable storage medium storing a computer program, which, when executed by a processor, can implement the steps and corresponding content of the aforementioned method embodiments.

[0091] This disclosure also provides a computer program product, including a computer program that, when executed by a processor, can implement the steps and corresponding content of the aforementioned method embodiments.

[0092] It should be understood that although arrows indicate various operation steps in the flowcharts of the embodiments of this disclosure, the order in which these steps are implemented is not limited to the order indicated by the arrows. Unless explicitly stated herein, in some implementation scenarios of the embodiments of this disclosure, the implementation steps in each flowchart can be executed in other orders as required. Furthermore, some or all of the steps in each flowchart may include multiple sub-steps or multiple stages based on the actual implementation scenario. Some or all of these sub-steps or stages can be executed at the same time, and each sub-step or stage can also be executed at different times. In scenarios where execution times differ, the execution order of these sub-steps or stages can be flexibly configured as required, and the embodiments of this disclosure do not limit this.

[0093] The above description is only an optional implementation method for some implementation scenarios of this disclosure. It should be noted that for those skilled in the art, other similar implementation methods based on the technical concept of this disclosure without departing from the technical concept of this disclosure also fall within the protection scope of the embodiments of this disclosure.

Claims

1. A method for detecting electrode degradation, characterized in that, include: Without using electrode contacts, determine the initial physical efficacy parameters of the electrode contacts, the initial neural response parameters of the subject under stimulation by the electrode contacts, and the initial autonomic electromyography parameters of the subject. After using the electrode contacts for a preset duration, determine the current physical efficacy parameters of the electrode contacts, the current neural response parameters of the subject under the stimulation of the electrode contacts, and the current autonomic electromyography parameters of the subject. Determine whether the electrode contact is degraded based on at least one of the following: The difference between the current physical performance parameters and the initial physical performance parameters The difference between the current neural response parameters and the initial neural response parameters The difference between the current voluntary electromyography (EMG) parameters and the initial voluntary EMG parameters.

2. The electrode degradation detection method according to claim 1, characterized in that, The determination of whether the electrode contact is degraded is based on at least one of the following: If the current physical performance parameters indicate physical degradation of the electrode interface compared to the initial physical performance parameters, then the electrode contact is determined to have degraded. Otherwise, if the current neural response parameters indicate a decrease in stimulation efficiency compared to the initial neural response parameters, and the current autonomic electromyography parameters do not increase compared to the initial autonomic electromyography parameters, then the electrode contacts are determined to have degenerated. Otherwise, the electrode contacts are determined not to have degenerated, and the change in the current neural response parameters is attributed to a neurorehabilitation effect.

3. The electrode degradation detection method according to claim 2, characterized in that, The initial physical performance parameters include the initial charge injection capacity and the initial electrode tissue interface impedance, and the current physical performance parameters include the current charge injection capacity and the current electrode tissue interface impedance. The initial neural response parameters include the initial minimum stimulation current that generates electromyography, and the current neural response parameters include the current minimum stimulation current that generates electromyography. The physical degradation includes: the current electrode tissue interface impedance increasing by a first preset percentage compared to the initial electrode tissue interface impedance, and the current charge injection capacity decreasing by a second preset percentage compared to the initial charge injection capacity. The reduction in stimulation efficiency includes: the current minimum stimulation current being higher than the initial minimum stimulation current.

4. The electrode degradation detection method according to claim 2 or 3, characterized in that, The initial voluntary electromyography (EMG) parameters include the initial detected motor units and the initial voluntary EMG amplitude, and the current EMG parameters include the current detected motor units and the current voluntary EMG amplitude; The absence of enhancement includes: the currently detected motor unit has not increased and the current spontaneous electromyography amplitude is lower than or equal to the initial spontaneous electromyography amplitude; The method further includes: when the current autonomic electromyography parameters are enhanced compared to the initial autonomic electromyography parameters, outputting a neurorehabilitation effect indication, and determining that the electrode contacts have not degenerated; The enhancement includes: an increase in the currently detected motor unit, and / or, a current voluntary electromyography (EMG) amplitude higher than the initial voluntary EMG amplitude.

5. The electrode degradation detection method according to claim 1, characterized in that, The method further includes: Degraded electrode contacts are used as electrode contacts to be replaced, and non-degraded electrode contacts are used as candidate electrode contacts. Based on the similarity between the activation weight matrix of the candidate electrode contact and the activation weight matrix of the electrode contact to be replaced, a target electrode contact for replacing the electrode contact to be replaced is determined from the candidate electrode contacts.

6. The electrode degradation detection method according to claim 5, characterized in that, The activation weight matrix is ​​obtained in the following way: For each electrode contact, during the application of a test pulse with preset parameters to the electrode contact, multi-channel surface electromyography is collected to obtain the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation center of gravity. Based on the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation centroid, the activation weight matrix of the electrode contact for the target muscle group and adjacent muscle groups is determined.

7. The electrode degradation detection method according to claim 1, characterized in that, The method further includes: If the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is consistent with the initial autonomic electromyography parameter, then the degradation type of the electrode contact is determined to be physical degradation; If the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is enhanced compared to the initial autonomic electromyography parameter, the degradation type of the electrode contact is determined to be mixed degradation.

8. An electrode degradation detection system, characterized in that, include: The acquisition module is used to determine the initial physical efficacy parameters of the electrode contacts, the initial neural response parameters of the subject under stimulation by the electrode contacts, and the initial autonomic electromyography parameters of the subject without using the electrode contacts. The acquisition module is also used to determine the current physical efficacy parameters of the electrode contact, the current neural response parameters of the subject under the stimulation of the electrode contact, and the current autonomic electromyography parameters of the subject after using the electrode contact for a preset time. The processing module is configured to determine whether the electrode contact is degraded based on at least one of the following: The difference between the current physical performance parameters and the initial physical performance parameters The difference between the current neural response parameters and the initial neural response parameters The difference between the current voluntary electromyography (EMG) parameters and the initial voluntary EMG parameters.

9. The electrode degradation detection system according to claim 8, characterized in that, The processing module is used for: If the current physical performance parameters indicate physical degradation of the electrode interface compared to the initial physical performance parameters, then the electrode contact is determined to have degraded. Otherwise, if the current neural response parameters indicate a decrease in stimulation efficiency compared to the initial neural response parameters, and the current autonomic electromyography parameters do not increase compared to the initial autonomic electromyography parameters, then the electrode contacts are determined to have degenerated. Otherwise, the electrode contacts are determined not to have degenerated, and the change in the current neural response parameters is attributed to a neurorehabilitation effect.

10. The electrode degradation detection system according to claim 9, characterized in that, The initial physical performance parameters include the initial charge injection capacity and the initial electrode tissue interface impedance, and the current physical performance parameters include the current charge injection capacity and the current electrode tissue interface impedance. The initial neural response parameters include the initial minimum stimulation current that generates electromyography, and the current neural response parameters include the current minimum stimulation current that generates electromyography. The physical degradation includes: the current electrode tissue interface impedance increasing by a first preset percentage compared to the initial electrode tissue interface impedance, and the current charge injection capacity decreasing by a second preset percentage compared to the initial charge injection capacity. The reduction in stimulation efficiency includes: the current minimum stimulation current being higher than the initial minimum stimulation current.

11. The electrode degradation detection system according to claim 9 or 10, characterized in that, The initial voluntary electromyography (EMG) parameters include the initial detected motor units and the initial voluntary EMG amplitude, and the current EMG parameters include the current detected motor units and the current voluntary EMG amplitude; The absence of enhancement includes: the currently detected motor unit has not increased and the current spontaneous electromyography amplitude is lower than or equal to the initial spontaneous electromyography amplitude; The processing module is further configured to: when the current autonomic electromyography parameters are enhanced compared to the initial autonomic electromyography parameters, output a neurorehabilitation effect prompt, and determine that the electrode contacts have not degenerated; The enhancement includes: an increase in the currently detected motor unit, and / or, a current voluntary electromyography (EMG) amplitude higher than the initial voluntary EMG amplitude.

12. The electrode degradation detection system according to claim 8, characterized in that, The processing module is also used for: Degraded electrode contacts are used as electrode contacts to be replaced, and non-degraded electrode contacts are used as candidate electrode contacts. Based on the similarity between the activation weight matrix of the candidate electrode contact and the activation weight matrix of the electrode contact to be replaced, a target electrode contact for replacing the electrode contact to be replaced is determined from the candidate electrode contacts.

13. The electrode degradation detection system according to claim 12, characterized in that, The activation weight matrix is ​​obtained in the following way: For each electrode contact, during the application of a test pulse with preset parameters to the electrode contact, multi-channel surface electromyography is collected to obtain the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation center of gravity. Based on the activation amplitude of the target muscle group, the distribution of the activated muscle group, and the coordinates of the activation centroid, the activation weight matrix of the electrode contact for the target muscle group and adjacent muscle groups is determined.

14. The electrode degradation detection system according to claim 8, characterized in that, The processing module is also used for: If the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is consistent with the initial autonomic electromyography parameter, then the degradation type of the electrode contact is determined to be physical degradation; If the current physical performance parameter indicates physical degradation of the electrode interface compared to the initial physical performance parameter, and the current autonomic electromyography parameter is enhanced compared to the initial autonomic electromyography parameter, the degradation type of the electrode contact is determined to be mixed degradation.

15. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program that, when executed by a processor, implements the method of any one of claims 1 to 7.

16. A computer program product, comprising a computer program, characterized in that, When the computer program is executed by a processor, it implements the method of any one of claims 1 to 7.

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