Adaptive spinal cord neuromodulation system

Abstract

The embodiment of the application relates to the technical field of medical devices, and discloses a self-adaptive spinal cord nerve regulation system, which comprises a stimulation electrode used for implanting in a body of a subject and performing electrical stimulation through a plurality of contacts; a muscle group acquisition module used for acquiring activation information of a target muscle group of the subject after the stimulation electrode performs electrical stimulation; an impedance measurement module used for measuring impedance information between different contacts of the stimulation electrode; a storage module used for storing a test pulse sequence, a treatment pulse sequence, baseline activation information and baseline impedance information of the subject; and a regulation module used for determining that the subject appears a first condition or a second condition based on a first comparison result and a second comparison result, updating the baseline activation information and / or the baseline impedance information, or adjusting the treatment pulse sequence; the first comparison result is a comparison result of target activation information and the baseline activation information; and the second comparison result is a comparison result of target impedance information and the baseline impedance information.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to an adaptive spinal cord nerve modulation system. Background Technology

[0002] Implantable neuromodulation systems have been widely used to treat various neurological diseases (such as Parkinson's disease and epilepsy). In practical applications, to achieve long-term, stable, and precise modulation of the target neural tissue, it is usually necessary to set a set of initial stimulation parameters during implantation or in the early postoperative period. This ensures that the electric field generated by the electrodes effectively covers the target neural structure and induces the expected neural activation response, thereby maintaining the ideal therapeutic effect.

[0003] However, as implantation time progresses, complex biological and electrochemical changes occur at the electrode-tissue interface, such as protein adsorption on the electrode surface, fibrous capsule formation, tissue inflammation, and electrode corrosion, leading to altered interfacial impedance and decreased charge injection efficiency. Furthermore, the functional characteristics of the target neural tissue itself may evolve due to factors such as neural plasticity, disease progression, and organismal growth and development. These dynamic changes render the initially set fixed stimulation parameters unsuitable, thus preventing the neural modulation system from maintaining optimal control. Summary of the Invention

[0004] This application provides an adaptive spinal cord nerve modulation system to solve the problem that existing nerve modulation systems cannot maintain good modulation effects for a long time.

[0005] According to a first aspect of the embodiments of this application, an adaptive spinal cord nerve modulation system is provided, comprising: Stimulation electrodes are implanted into the body of a subject to provide electrical stimulation through multiple contacts. The muscle group acquisition module is used to acquire activation information of the target muscle group of the object after electrical stimulation is performed by the stimulation electrode. An impedance measurement module is used to measure the impedance information between different contacts of the stimulation electrode; The storage module is used to store test pulse sequences, treatment pulse sequences, baseline activation information and baseline impedance information of the object; The control module is used to acquire target activation information and target impedance information, and determine whether the object is in a first situation or a second situation based on a first comparison result and a second comparison result; wherein, the first situation is that the tissue interface in the area where the stimulation electrode is implanted changes; and the second situation is that the target neural tissue targeted by the stimulation electrode undergoes neural function remodeling. The control module is further configured to update the baseline activation information and / or the baseline impedance information when the second condition is determined to occur in the object, and to adjust the treatment pulse sequence when the first condition is determined to occur in the object; The target activation information is the activation information collected by the muscle group acquisition module after the stimulation electrode performs electrical stimulation according to the test pulse sequence at the target time; the target impedance information is the impedance information measured by the impedance measurement module at the target time. The first comparison result is the comparison result between the target activation information and the baseline activation information; the second comparison result is the comparison result between the target impedance information and the baseline impedance information.

[0006] Optionally, the activation information includes at least one of the following: activation amplitude of the target muscle group, distribution information of co-activated muscle groups, and coordinates of the activation center of gravity; The first comparison result includes at least one of the following: the rate of change of activation amplitude of the target muscle group, the rate of change of co-activation degree of the non-target muscle group, and the centroid offset vector of the spatial distribution of the activated muscle group.

[0007] Optionally, the second comparison result includes: the overall impedance change value of the target impedance information relative to the baseline impedance information, and the relative impedance ratio between each contact pair.

[0008] Optionally, the control module includes a first control unit; The first control unit is used to adjust the stimulation parameters in the treatment pulse sequence when the first comparison result and the second comparison result meet a first condition; the first condition includes: The first comparison result indicates that at least one of the following is true: the rate of change of activation amplitude of the target muscle group is greater than the first threshold, the rate of change of co-activation degree of non-target muscle groups is increased, and the centroid offset vector of the spatial distribution of activated muscle groups is greater than the second threshold. The second comparison result indicates that the overall impedance change is greater than the third threshold.

[0009] Optionally, the control module includes a second control unit; The second control unit is used to adjust the baseline activation information in the storage module to the target activation information, and / or adjust the baseline impedance information in the storage module to the target impedance information, when the first comparison result and the second comparison result satisfy a second condition: The second condition includes: The first comparison result indicates at least one of the following: the rate of change of activation amplitude of the target muscle group is less than or equal to a first threshold, the rate of change of co-activation degree of non-target muscle groups decreases, and the centroid offset vector of the spatial distribution of activated muscle groups is less than or equal to a second threshold. The second comparison result indicates that the overall impedance change is less than or equal to the third threshold.

[0010] Optionally, the stimulation parameters include at least one of pulse width and current intensity.

[0011] Optionally, the control module includes: a contact update unit, used for: If the first comparison result indicates that the centroid offset vector of the spatial distribution of the activated muscle group is greater than the fourth threshold, the correspondence between the plurality of touch points and the target muscle group is updated based on the target activation information.

[0012] Optionally, the touch update unit includes: The first update subunit is used to determine the actual activated muscle group corresponding to each contact point at the current moment based on the target activation information. The second update subunit is used to calculate the activation amplitude of the target muscle group and the co-activation degree of the non-target muscle group for each contact point or combination of contact points. The third update subunit is used to select the contact point or contact point combination that maximizes the activation amplitude of the target muscle group and minimizes the co-activation degree of the non-target muscle group, and establish a correspondence between it and the target muscle group.

[0013] Optionally, the control module includes: a contact verification unit, used for: After updating the correspondence between the multiple contact points and the target muscle group, electrical stimulation is performed through the stimulation electrode according to the test pulse sequence, and the verification activation information collected by the muscle group acquisition module is obtained; the updated correspondence is verified based on the verification activation information.

[0014] Optionally, the adaptive spinal cord nerve modulation system further includes: The message module is used to generate an adjustment message before the control module adjusts the treatment pulse sequence; The communication module is used to send the target activation information, the target impedance information, the first comparison result, multiple items in the second comparison result, and the adjustment message to an external device; and to receive an external pulse sequence sent by the external device. The process by which the control module adjusts the treatment pulse sequence includes updating the treatment pulse sequence stored in the storage module to the external pulse sequence.

[0015] The beneficial effects of the technical solutions provided in this application are: In this embodiment, by configuring stimulation electrodes, a muscle group acquisition module, an impedance measurement module, a storage module, and a control module, the system can simultaneously acquire and compare activation information representing functional response with impedance information representing tissue interface state, achieving cross-validation of dual-modal data. Based on the comparison results of target activation information and baseline activation information, as well as the comparison results of target impedance information and baseline impedance information, the control module can further identify the specific causes of drift in the control / stimulation effect, thereby driving different system response actions to adaptively compensate for the drift, enabling the system to maintain a good control effect over a long period. This embodiment can shield the complexity of electrode hardware state changes, achieving long-term stability and precision in the control effect. Attached Figure Description

[0016] The above and / or additional aspects and advantages of this application will become apparent and readily understood from the following description of the embodiments taken in conjunction with the accompanying drawings, wherein: Figure 1 This is a schematic diagram of the structure of the adaptive spinal cord nerve modulation system provided in the embodiments of this application. Detailed Implementation

[0017] The embodiments of this application 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 application, and do not constitute a limitation on the technical solutions of the embodiments of this application.

[0018] Those skilled in the art will understand that, unless otherwise stated, 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 the embodiments of this application 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 one element can be directly connected or coupled to the other element, or it can mean that the one element and the other element establish a connection relationship 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 the embodiments of this application, “multiple” can 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.

[0019] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be described in further detail below with reference to the accompanying drawings.

[0020] In the field of spinal cord nerve electrical stimulation modulation, in order to enable electrical stimulation to activate target nerve tissue in a long-term and stable manner, the following approach can be adopted: during the use of the neuromodulation system, professionals continuously calibrate the preset stimulation parameter sequence of the neuromodulation system to compensate for the drift of the system's modulation effect.

[0021] However, the above approach does not perform ideally when applied to long-term management scenarios lasting from weeks to months. A fundamental contradiction lies in the fact that after long-term implantation, when a decrease in the activation amplitude or a shift in the center of activation of the target muscle group is observed, this change may stem from increased impedance at the electrode-tissue interface due to fiber encapsulation, beneficial functional remodeling of the nervous system itself, or even physical displacement of the electrode as a whole. If these three distinct physical and physiological processes cannot be distinguished, clinicians can only make tentative adjustments based on experience, potentially misinterpreting beneficial neural remodeling as a change in device status and thus intervening inappropriately.

[0022] To overcome the aforementioned contradictions, this application proposes a different technical approach. The core inventive concept of this application lies in configuring stimulation electrodes, a muscle group acquisition module, an impedance measurement module, a storage module, and a control module. This enables the system to simultaneously acquire and compare activation information representing functional response with impedance information representing tissue interface state, achieving cross-validation of dual-modal data. Based on the comparison results of target activation information and baseline activation information, as well as the comparison results of target impedance information and baseline impedance information, the control module can further identify the specific causes of drift in the control / stimulation effect, thereby driving different system response actions to adaptively compensate for the drift, allowing the system to maintain a good control effect over a long period. This application can shield the complexity of electrode hardware state changes, achieving long-term stability and precision in the control effect.

[0023] Activation information (muscle activation amplitude, distribution information of co-activated muscle groups, activation center of gravity, etc.) can characterize the functional response induced by electrical stimulation; impedance information (overall impedance change value, relative impedance ratio between each contact pair, etc.) can characterize the electrical state of the electrode-tissue interface. These two types of information have completely different physical dimensions and exhibit different sensitivities and specificities to different types of physiological changes: activation information is sensitive to any factor that causes changes in stimulation effects, but cannot distinguish the source of these factors; impedance information is sensitive to changes in the state of the tissue interface, but not to neural functional remodeling. This application utilizes the complementary relationship between these two types of information in terms of sensitivity and specificity to construct an identification mechanism specifically addressing the technical problem of "unknown causes of effect drift" during the long-term operation of implantable neuromodulation systems. For example, when activation information indicates a drift in functional response, the system does not directly adjust the stimulation parameters. Instead, it further examines the changing patterns of impedance information. If the impedance information shows a stable tissue interface, the functional drift originates from neural remodeling, and the system should update the baseline rather than adjust the treatment parameters. If the impedance information shows significant changes in the tissue interface, the functional drift originates from physical / electrical changes in the stimulation pathway, and the system should adjust the treatment parameters to compensate. This joint analysis of "functional-state" bimodal information allows the system to effectively distinguish various causes of drift in modal effects (fiber encapsulation, electrode displacement, neural remodeling) without relying on imaging equipment (such as X-rays or CT scans), and to execute differentiated adaptive responses accordingly. This technical effect is unattainable by any existing approach that relies solely on electromyographic signal comparison or impedance monitoring—no matter how complex the comparison or processing at the data level, single-modal information cannot solve the fundamental diagnostic problem of "what causes the change in effect."

[0024] This application provides an adaptive spinal cord nerve modulation system, also known as a spinal cord stimulation device, which is an implanted device that outputs electrical stimulation signals to specific segments of the spinal cord. The system releases pulsed currents with specific parameters to the dorsal or ventral side of the spinal cord through a preset electrode array to activate the neural pathways of the target muscle group, thereby inducing or enhancing muscle contraction, or maintaining the muscle's activated state.

[0025] like Figure 1 As shown, the adaptive spinal cord nerve modulation system includes: stimulation electrode 101, muscle group acquisition module 102, impedance measurement module 103, storage module 104 and modulation module 105. The stimulation electrode 101 is used to be implanted in the body of the subject and to provide electrical stimulation through multiple contacts. When an electrical pulse is applied, each contact can generate an electric field in a specific area of ​​the subject's body to activate or regulate the target nerve tissue.

[0026] The stimulation electrode 101 can be, for example, a paddle-shaped electrode array with a rigid substrate and multiple independent metal contacts distributed thereon. Because the substrate is rigid, the relative spatial geometry between the contacts remains fixed during use. Each contact can independently receive pulse signals and accordingly release charge to surrounding tissues. For example, the stimulation electrode 101 can be implanted along the epidural or subdural space of the spinal cord, so that its contact array covers the spinal cord segment innervating the target muscle group.

[0027] The muscle group acquisition module 102 is used to acquire activation information of the target muscle group of the subject after electrical stimulation by the stimulation electrode 101.

[0028] The muscle acquisition module 102 works in conjunction with the stimulation electrode 101. After electrical stimulation is applied by the stimulation electrode 101, the muscle acquisition module 102 acquires activation information of the target muscle group in the subject's body. This activation information reflects the muscle response induced by the electrical stimulation.

[0029] In some embodiments, activation information can refer to any set of data capable of quantifying the functional response states of target and non-target muscle groups induced by electrical stimulation. For example, activation information may include, but is not limited to: activation amplitude directly reflecting muscle contraction intensity, co-activated muscle group distribution information describing the relative relationship between co-activated muscle groups and the target muscle group, and activation centroid coordinates representing the spatial weighted center position of the activated muscle group. Co-activation refers to the unexpected co-contraction of non-target muscle groups under target stimulation. In this embodiment, the target muscle group is the muscle group primarily acted upon by the stimulation electrode 101. For example, after the stimulation electrode 101 is implanted in a paraplegic patient, electrical stimulation is applied to muscle group A through the stimulation electrode 101 to achieve treatment or rehabilitation training for the paraplegic patient; in this case, muscle group A is the target muscle group.

[0030] Impedance measurement module 103 is used to measure the impedance information between different contacts of stimulation electrode 101. Impedance measurement module 103 is electrically connected to stimulation electrode 101; In some embodiments, the impedance information can characterize the conductivity and state of the tissue medium surrounding the electrode contacts. Impedance information can refer to a set of data that reflects the conductivity and state of the tissue medium surrounding the electrodes, obtained by applying electrical signals to different combinations of contacts in an implanted electrode array and taking measurements. For example, impedance information may include, but is not limited to: impedance values ​​between adjacent contact pairs, impedance values ​​between spaced-apart contact pairs, or an inter-electrode impedance relationship matrix constructed based on these measurements to characterize the relative impedance pattern between the contacts.

[0031] Storage module 104 is used to store test pulse sequences, treatment pulse sequences, baseline activation information of the subject, and baseline impedance information.

[0032] In some embodiments, the storage module 104 may be a non-volatile memory, such as flash memory or electrically erasable programmable read-only memory, to ensure that data is not lost after the system is powered off.

[0033] The test pulse sequence can be a set of predefined, parameter-normalized pulse sequences. The test pulse sequence is used to apply standardized test stimuli to the subject at a target time to collect repeatable and comparable activation and impedance information. In some embodiments of this application, the stimulus intensity of the test pulse sequence is lower than the subject's sensory or motor threshold to ensure that the subject does not experience discomfort or harm during the test.

[0034] The treatment pulse sequence is an electrical pulse sequence set according to the specific condition and treatment goals of the subject. It is used to output to the spinal nerve target of the subject via the stimulation electrode 101 during routine treatment to achieve the expected therapeutic effect or rehabilitation training purpose.

[0035] Baseline activation information and baseline impedance information are collectively referred to as baseline information. Baseline information serves as an initial reference dataset established at a reference time for comparing the differences with measurement data at subsequent target times, acting as a benchmark for the control module 105 to perform difference discrimination and cause identification. Specifically, baseline activation information reflects the functional response state of the target muscle group induced by the stimulation electrode 101 after electrical stimulation according to the test pulse sequence at the reference time; baseline impedance information reflects the impedance state between different contacts of the stimulation electrode 101 at the reference time, i.e., the electrical characteristics of the stimulation electrode-tissue interface.

[0036] In some embodiments of this application, the reference time can be after the postoperative stimulation electrode 101 is implanted in the ideal position, at the initial startup of the system, or at the time of the last baseline update. Optionally, baseline activation information and / or baseline impedance information can be updated in response to instructions from the control module 105 (e.g., when neural functional remodeling of the subject is identified).

[0037] The control module 105 is used to acquire target activation information and target impedance information, and determine whether the object has a first condition or a second condition based on the first comparison result and the second comparison result; wherein, the first condition is that the tissue interface of the area where the stimulation electrode is implanted changes; the second condition is that the target neural tissue targeted by the stimulation electrode undergoes neural function remodeling; the control module 105 is also used to update the baseline activation information and / or baseline impedance information when the object is determined to have a second condition, and to adjust the treatment pulse sequence when the object is determined to have a first condition.

[0038] Among them, the target activation information is the activation information collected by the muscle group acquisition module 102 after the stimulation electrode 101 performs electrical stimulation according to the test pulse sequence at the target time; the target impedance information is the impedance information measured by the impedance measurement module 103 at the target time.

[0039] It is understood that the control module 105 is communicatively connected to the muscle group acquisition module 102, the impedance measurement module 103, and the storage module 104 to access data. The control module 105 can obtain target activation information acquired at a specific target time from the muscle group acquisition module 102 and target impedance information measured at that target time from the impedance measurement module 103. The aforementioned target time can refer to a periodic follow-up time point several weeks or months after implantation. The control module 105 further reads the baseline activation information and baseline impedance information from the storage module 104 and compares the information at the target time with the baseline information to obtain a first comparison result and a second comparison result. The target time can be a preset time in the adaptive spinal cord nerve modulation system; for example, periodic information can be stored in the storage module 104, allowing target activation information and target impedance information to be acquired once per period, thereby enabling adaptive adjustment through the control module 105. The target time can also be the time input from an external device or the time when a specific event is triggered by an external device. For example, a specific event of the adaptive spinal cord modulation system can be triggered by a professional medical person through an external device. This specific event may be, for example, acquiring target activation information and target impedance information, and then achieving an adaptive adjustment through the modulation module 105.

[0040] The first comparison result is the comparison between target activation information and baseline activation information, which quantifies the degree of drift in functional response. The second comparison result is the comparison between target impedance information and baseline impedance information, which quantifies the degree of change in tissue interface state. Based on these comparison results, the modulation module 105 can determine the changes that have occurred in the object. Here, a binary classification method can be used to divide the changes in the object into two categories: one is a change in the tissue interface of the area where the stimulating electrode is implanted, i.e., the first case; the other is neural functional remodeling of the target neural tissue targeted by the stimulating electrode, i.e., the second case. In this way, the cause of the difference between target activation information and baseline activation information can be determined, which can also be regarded as whether the modulation effect / stimulation effect has drifted and the specific cause in the recent period after the stimulating electrode is implanted in the object.

[0041] Then, depending on the situation, the control module 105 decides whether to update the baseline information in the storage module 104 or adjust the stored treatment pulse sequence, thereby controlling the subsequent electrical stimulation output through the stimulation electrode 101.

[0042] In some embodiments, the adaptive spinal cord nerve modulation system further includes a processor connected to the stimulation electrode 101, the muscle group acquisition module 102, the impedance measurement module 103, the storage module 104, and the modulation module 105. For example, the processor can read test pulse sequences and treatment pulse sequences from the storage module 104. It can then control the stimulation electrode 101 to apply electrical stimulation according to the test pulse sequences and treatment pulse sequences. After the stimulation electrode 101 applies electrical stimulation, the processor can also control the muscle group acquisition module 102 and the impedance measurement module 103 to acquire target activation information and target impedance information. The processor can also control the modulation module 105 to operate.

[0043] It should be noted that long-term management of paralysis rehabilitation typically involves unique constraints that differ from general data fusion applications. First, once implanted electrodes are placed in the body, their spatial location cannot be determined in real time using conventional methods. While X-rays or CT scans can confirm electrode location, they are costly and involve radiation exposure, making them unsuitable for routine monitoring. Second, fibrosis at the electrode-tissue interface is a gradual and irreversible physiological process, and its impedance changes may exhibit similar characteristics to those caused by electrode displacement on a single impedance curve. Third, neural functional remodeling is a desired positive outcome of rehabilitation therapy, but this remodeling alters the original stimulus-response mapping. If the system cannot recognize this change and distinguish it from "equipment problems," it may interfere with the rehabilitation process due to "misdiagnosis." These constraints mean that in the field of paralysis rehabilitation, a simple "measurement-comparison-adjustment" closed loop is far from sufficient. The system must possess "diagnostic" capabilities, meaning it must be able to determine the cause of changes in effectiveness based on the joint analysis of multimodal information, rather than merely detecting the existence of changes.

[0044] This application is designed specifically to address the aforementioned constraints. By simultaneously acquiring activation and impedance information, the system obtains two independent observation dimensions with different physical meanings and different response characteristics to different interference factors. When the activation information shows a drift in the functional response, the impedance information provides crucial "comparison" information: if the impedance pattern (the relative impedance ratio between each contact pair) remains stable while the overall impedance shows a trend of increasing, it points to a gradual change in the tissue interface of fiber encapsulation; if the impedance pattern becomes disordered while the overall impedance change has no clear trend, it points to physical displacement of the electrodes; if the overall impedance information is stable while the activation information shows improved function, it points to neural function remodeling. This diagnostic logic based on "function-state" bimodal cross-validation enables the system to effectively identify various causes of effect drift without the intervention of imaging equipment, and execute targeted adaptive responses accordingly, thereby achieving true "precise control".

[0045] In this application, the functional response drift can refer to any observable and quantifiable change in the muscle activation pattern at a target time relative to the baseline muscle activation pattern, caused by any reason. This change can be beneficial, such as reduced co-activation due to neural remodeling; or detrimental, such as decreased activation levels due to tissue interface fibrosis. Changes in tissue interface state can refer to any alteration in the electrical, chemical, or physical properties between the electrode contact and the surrounding biological tissue, such as increased local tissue impedance due to fibrous capsule formation, or changes in charge transfer impedance on the electrode surface.

[0046] It should be noted that the implementation of the muscle group acquisition module 102 and impedance measurement module 103 provides the control module 105 with the ability to simultaneously acquire functional and state dual-modal information. By cross-analyzing the first and second comparison results, the control module 105 can identify the causes of drift and execute differentiated response strategies. For example, when functional drift is accompanied by changes in tissue interface state, parameter adjustments are performed to restore effective activation; when function improves and the tissue interface state stabilizes, the current function is updated to a new baseline. This architecture of dual-modal data fusion, cross-comparison, and collaborative processing solves the technical problem of effectively distinguishing different types of state changes and performing adaptive compensation without relying on electrode spatial position detection.

[0047] To further optimize the quantification accuracy of functional response and thus provide accurate input for subsequent differential diagnosis and control decisions, in some embodiments of this application, the activation information includes at least one of the following: activation amplitude of the target muscle group, distribution information of co-activated muscle groups, and activation centroid coordinates. The first comparison result includes at least one of the following: the rate of change of activation amplitude of the target muscle group, the rate of change of co-activation degree of the non-target muscle group, and the centroid offset vector of the spatial distribution of activated muscle groups.

[0048] It should be noted that the activation amplitude of the target muscle group can refer to the amplitude intensity of the compound muscle action potential generated by the stimulated target muscle group. For example, the muscle group acquisition module 102 includes surface electromyography electrodes placed at the muscle belly of the target muscle group. It can extract the signal peak value or root mean square value within a specific time window after the stimulation artifact from the acquired signals, using this as the activation amplitude of the target muscle group. This indicator can directly reflect the effective activation ability of electrical stimulation on the target muscle group or target nerve target. The higher the amplitude, the stronger the recruitment ability of the stimulation on the target muscle group.

[0049] Co-activated muscle group distribution information refers to which adjacent or antagonistic non-target muscle groups are activated besides the target muscle group, and the level of activation of each group. In other words, it describes the simultaneous, unintended activation of pre-set monitoring muscle groups (i.e., non-target muscle groups, usually adjacent or synergistic / antagonistic muscle groups) in addition to the target muscle group during electrical stimulation. This information describes the spatial distribution pattern of "crosstalk" and the degree of activation of each muscle group. It can reflect the spatial selectivity or focus of the stimulus. The more concentrated the distribution is on the target muscle group, and the lower the amplitude of the co-activated muscle groups, the better the selectivity of the stimulus and the fewer the side effects.

[0050] The activation center of gravity coordinates refer to the spatial coordinates obtained by weighting and averaging the anatomical spatial coordinates of all monitored muscle groups, with their respective activation amplitudes as weights. It represents the "central point" of the overall muscle activity induced by the current stimulus.

[0051] When the activation information includes the activation amplitude of the target muscle group, the first comparison result includes the rate of change of the activation amplitude of the target muscle group. This rate of change can refer to the percentage change in the activation amplitude of the target muscle group at the target time relative to the baseline activation amplitude. Positive values ​​indicate enhancement, and negative values ​​indicate reduction. A sustained and significant negative change may indicate changes in tissue interface or electrode displacement leading to decreased stimulation efficiency.

[0052] When the activation information includes information on the distribution of co-activated muscle groups, the first comparison result includes the rate of change in the co-activation level of non-target muscle groups. This rate of change in the co-activation level of non-target muscle groups can refer to the percentage change in the current value relative to the baseline after aggregating the multi-channel vector of co-activated muscle group distribution information into a scalar "co-activation level". The aggregation method can be the weighted sum of the activation amplitudes of all non-target muscle groups, the root mean square value, or the maximum value. An increased rate of change indicates increased crosstalk and decreased selectivity. A decreased rate of change is key evidence of improved stimulus selectivity and positive remodeling of neural function. For example, the co-activation level can be calculated using the following formula: ; C represents the degree of co-activation, and N represents the number of non-target muscle groups being monitored. Indicates the first The activation amplitude of a non-target muscle group measured after stimulation. Represented as the first The weighting coefficient of a non-target muscle group can be set based on the anatomical proximity or clinical relevance between the non-target muscle group and the target muscle group.

[0053] When the activation information includes the coordinates of the activation centroid, the first comparison result includes the centroid offset vector of the spatial distribution of the activated muscle group. This centroid offset vector describes the magnitude and direction of spatial displacement of the current activation centroid relative to the baseline activation centroid. A significant offset directly reflects a spatial drift of the overall activation target points.

[0054] In this embodiment, the evaluation of the effect of neuromodulation is elevated from a simple judgment of "presence" or "magnitude" of activation to a multi-dimensional quantitative system that includes intensity, selectivity, and spatial localization, enabling the capture of more subtle and complex functional change patterns. For example, a decrease in activation amplitude may be caused by a variety of reasons, but if a significant shift in the activation center of gravity and an increase in co-activation are observed simultaneously, it is more likely to indicate changes in tissue interface or electrode displacement; while if the activation amplitude is stable or increases, the activation center of gravity remains stable or converges to the target region, and the degree of co-activation decreases, it is more likely to indicate neural functional remodeling.

[0055] In this embodiment of the application, by employing these specific quantitative indicators, the functional response drift can be evaluated in a refined and numerical manner, which helps the system to execute subsequent differential diagnostic logic more accurately, thereby synergistically enhancing the overall technical effect of the present invention in achieving long-term stability and precise neural modulation.

[0056] In some embodiments of this application, the second comparison result includes: the overall impedance change value of the target impedance information relative to the baseline impedance information, and the relative impedance ratio between each contact pair.

[0057] It should be noted that the overall impedance change value can refer to the systematic change in the impedance values ​​of all or part of the specified contact pairs in the inter-electrode impedance relationship matrix at the target time, relative to the impedance values ​​of the corresponding contact pairs in the baseline impedance relationship matrix, at the overall level. It reflects the macroscopic trend of change in the dielectric properties of the tissue interface surrounding the electrodes. A continuous and gradual upward trend in the overall impedance change value is a typical electrical characteristic of the physiological process of uniform growth and encapsulation by tissue fibers. This upward trend indicates that the electrode surface is gradually being covered by high-resistance fibrous tissue. In some embodiments, this change value can be calculated as the average or median of the impedance change rate of all or part of the measured contact pairs.

[0058] The relative impedance ratio between contact pairs refers to the relative magnitude relationship of the impedance values ​​between different contact pairs in the inter-electrode impedance relationship matrix. This ratio can be determined by the spatial distance between the contact pairs and the geometry of the current path.

[0059] Understandably, the stability of the relative impedance ratio is based on the physical premise that the geometric position between the contacts of the rigid substrate electrode remains unchanged. This stability specifically distinguishes between "uniform and diffuse changes in the tissue surrounding the electrode (such as fiber encapsulation)" and "deformation or damage to the electrode structure itself." Simultaneously, this stability provides an exclusive condition for using impedance information to determine the "state of change in the tissue interface"—abrupt changes in the impedance pattern are excluded from this state, allowing it to be used to trigger other early warning mechanisms.

[0060] In some embodiments, when the first comparison result indicates a functional drift (such as a decrease in the activation amplitude of the target muscle group) and the second comparison result indicates that the overall impedance change value is trending upward while the relative impedance ratio between each contact pair remains stable, the system determines that the tissue interface is in a state of change.

[0061] When the first comparison result indicates functional improvement (such as a decrease in the degree of co-activation of non-target muscle groups) and the second comparison result indicates that the overall impedance change value remains stable without trend drift, the system determines that the state of neural function remodeling is reached.

[0062] In this embodiment, impedance information is decomposed into two independent dimensions: "trend change" and "pattern stability," which can effectively identify different tissue interface states. For example, due to uniform fibrosis thickening of the tissue interface, the overall impedance may increase significantly. However, since the electrodes have not moved and the tissue morphology has not been distorted, the relative impedance ratio between each contact pair remains stable. Conversely, if the electrodes undergo physical displacement and enter different tissue microenvironments, not only may the overall impedance change, but the relative impedance ratio between each contact pair is also very likely to become significantly disordered.

[0063] In this embodiment of the application, by combining these two indicators, a precise evaluation basis is provided for determining whether the tissue interface has undergone progressive fibrosis or whether the electrode position has changed, thereby enhancing the accuracy and robustness of the differential diagnosis module.

[0064] In some embodiments of this application, the control module 105 includes a first control unit; The first control unit is used to adjust the stimulation parameters in the treatment pulse sequence when the first comparison result and the second comparison result meet a first condition; the first condition includes: The first comparison result indicates at least one of the following: the rate of change of activation amplitude of the target muscle group is greater than the first threshold, the rate of change of co-activation degree of non-target muscle groups is increased, and the centroid offset vector of the spatial distribution of activated muscle groups is greater than the second threshold. The second comparison result indicates that the overall impedance change is greater than the third threshold.

[0065] It should be noted that the first control unit is designed to address scenarios where adverse physiological changes occur at the tissue interface surrounding the electrode (such as thickening of the fibrous wrapping). The essence of this change is an increase in the impedance of the electrode-tissue interface, causing the stimulation current to attenuate or its diffusion path to change before reaching the target nerve tissue. When an adverse physiological change at the tissue interface is detected, the first control unit generates a stimulation parameter adjustment command, adjusting the stimulation parameters in the treatment pulse sequence to compensate for the loss of stimulation efficiency caused by the increased tissue interface impedance.

[0066] In some embodiments, the stimulation parameters include at least one of pulse width and current intensity.

[0067] It is understandable that the overall impedance change shows a continuous and gradual upward trend, which is a typical electrical characteristic of the physiological process of uniform growth of tissue fibers.

[0068] First, for implantable medical devices (such as deep brain stimulation devices and spinal cord stimulation devices), immune rejection and tissue repair are unavoidable physiological processes. Under this mechanism, cell proliferation occurs around the electrodes, forming dense glial scars or fibrous capsules. The water content of these proliferating tissues decreases sharply, constituting the physiological root cause of structural changes at the tissue interface.

[0069] Secondly, normal nerve tissue is rich in extracellular fluid, with active ion channels and good conductivity. However, the fibrous tissue generated by the aforementioned foreign body reaction is mainly composed of collagen and lacks ion channels, resulting in this region exhibiting a high impedance and low conductivity "insulating dielectric". According to this theory, the insertion of an insulating medium between the electrode and the target inevitably leads to a physical increase in contact resistance.

[0070] It is worth noting that, due to the formation of the aforementioned fibrous tissue (high-impedance fiber barrier), according to the volume conduction theory and charge shunting effect in the neural regulation system, the high-impedance fiber barrier will cause a severe local voltage drop, resulting in a sharp reduction in the effective current density reaching the target neuron (causing "activation amplitude decay"); at the same time, the spatially asymmetric insulating barrier will force the current to overflow to the non-target area with lower impedance, causing the actual activation volume to tilt and distort (causing "increased co-activation" and "center of gravity drift").

[0071] Furthermore, during long-term stimulation of the spinal cord's neuromodulation system, to prevent excitotoxicity, the system undergoes adaptive changes at the microscopic level, including receptor desensitization and downregulation, altered synaptic plasticity (downregulation of network excitability), and apoptosis of target neurons due to disease progression. This internal remodeling of the neuromodulation system also leads to functional degradation such as "activation amplitude decay." However, it is entirely different from "non-neural tissue remodeling." Because it does not change the macroscopic water content of the tissue, nor does it form a dense, high-resistivity collagen barrier, the physical pathways for current conduction are not blocked. Therefore, the dielectric constant of the electrode interface remains stable, and the overall electrical impedance does not change significantly.

[0072] Therefore, by introducing the intersection of the "functional condition" and the "overall impedance condition" (i.e., both must be satisfied simultaneously), this application logically forms a closed-loop chain of evidence that corroborates each other: The overall impedance increases significantly (confirming that a high-impedance insulating medium that conforms to the dielectric heterogeneity theory is indeed produced at the physical level) and is accompanied by the deterioration of at least one functional indicator (confirming that the insulating medium has actually caused distortion of the spatial electric field and voltage drop), which can be determined as a change in the organizational interface.

[0073] Specifically, functional conditions (such as activation amplitude decay, coactivation increase, and center of gravity shift) collectively describe the deterioration of neuromodulation effects. However, functional deterioration alone is insufficient to attribute it to tissue interface problems. Therefore, this application also introduces an impedance condition as another essential link in the "chain of evidence": a significant increase in overall impedance (greater than the third threshold) is a typical electrical characteristic of changes with insulating effects (such as fibrosis) occurring at the tissue interface.

[0074] In some embodiments, the first threshold can be a preset critical value used to define a "significant decrease" in stimulation efficiency. This first threshold is typically set as a negative percentage, such as -20%. When the absolute value of the rate of change in activation amplitude exceeds the first threshold, it indicates that the decrease in stimulation efficiency has exceeded the normal physiological fluctuation range.

[0075] An increased rate of change in coactivation of non-target muscle groups can be defined as a positive rate of change in coactivation exceeding a preset threshold (e.g., +15%). This indicates that the diffusion range of the stimulation current has increased compared to the baseline, and more non-target muscle groups have been unintentionally activated.

[0076] The second threshold can be a preset spatial distance threshold used to define the limit for "significant drift" of the activation center of gravity. This second threshold can be set according to clinical needs and electrode size, for example, 5 mm.

[0077] The first comparison result indicating any one of the above is considered to fulfill the functional condition. This "OR" logic design covers various forms of functional drift that may be triggered by changes in the organizational interface.

[0078] The third threshold can be a preset threshold for impedance change, used to distinguish between "meaningful tissue interface changes" and "measurement noise or meaningless minor fluctuations". This third threshold can be set as a certain percentage of the baseline overall impedance level, such as +10%.

[0079] In some embodiments, the first threshold can be preset to a 20% decrease in activation amplitude, the second threshold can be preset to a 5 mm shift in the center of gravity, and the third threshold can be preset to a 30% increase in average impedance. Only when at least one functional degradation indicator is met, and the overall impedance also meets the condition of a trend increase, is it determined to be a tissue interface change.

[0080] In this study, a geometrical deduction was performed using a second threshold preset at a center-of-gravity offset distance of 5 mm as an example: Taking a typical electrode array implanted in the T11-T12 spinal cord segment as an example (contact length 4 mm, width 2.5 mm, adjacent spacing 3 mm), based on these physical geometric dimensions, the geometric distance between the center points of two adjacent contacts is 7 mm (4 mm / 2 + 3 mm + 4 mm / 2). A 5 mm offset is not only greater than the absolute length of a single contact (4 mm), but also exceeds half the center-to-center distance between adjacent contacts (3.5 mm). This clearly demonstrates in physical space that the Virtual Active Area (VTA) has substantially slipped out of the coverage area of ​​the current target contact. This threshold setting represents a precise engineering quantification of "electric field off-target" behavior.

[0081] The third threshold is preset to a 30% increase in average impedance, which can produce a physiological filter effect: the impedance change of the implant in the human body caused by normal physiological fluctuations such as changes in patient position, local microcirculation, and hydration status is usually within 15%. In this embodiment, the third threshold is set to 30%, which constructs a highly reliable "signal-to-noise ratio filter" in engineering, effectively eliminating false positive interference from daily physiological fluctuations, thereby confirming that a dense fibrous capsule with an insulating effect has been formed on the electrode surface.

[0082] The first threshold is preset at a 20% decrease in activation amplitude, which can be considered the baseline for clinical intervention. In real clinical scenarios, even if the stimulation parameters remain constant, the evoked electromyographic amplitude of the target muscle group will be affected by dynamic factors such as slight postural shifts and natural muscle fatigue. Numerous electrophysiological studies have shown that normal physiological "electromyographic noise fluctuations" are usually within 10% to 15%. In this embodiment, the first threshold is set to 20%, successfully filtering out the aforementioned physiological noise using physical differences.

[0083] In this embodiment, when the condition for "adjusting stimulation parameters" is met, it can have a direct positive impact on the patient: without the need for a second revision surgery, the electric field weight distribution of the anode and cathode of the contact point can be changed, such as "pulling" the electric field that has shifted by 5mm back to the target anatomical area; at the same time, adaptive energy compensation overcomes the voltage drop caused by the fibrous insulation layer, so that the electromyographic activation amplitude returns to the baseline, thereby non-invasively restoring the original therapeutic effect.

[0084] In this embodiment, cross-validation of the drift characteristics of the functional dimension and the overall increase characteristics of the impedance dimension can pinpoint the specific physiological state change of "change in the tissue interface", thereby providing a reliable decision basis for subsequent parameter compensation and regulation.

[0085] In some embodiments of this application, the control module 105 includes a second control unit; The second control unit is used to adjust the baseline activation information in the storage module to the target activation information and / or adjust the baseline impedance information in the storage module to the target impedance information when the first comparison result and the second comparison result meet the second condition. The second condition includes: The first comparison result indicates at least one of the following: the rate of change of activation amplitude of the target muscle group is less than or equal to the first threshold, the rate of change of co-activation degree of non-target muscle groups decreases, and the centroid offset vector of the spatial distribution of activated muscle groups is less than or equal to the second threshold. The second comparison result indicates that the overall impedance change is less than or equal to the third threshold.

[0086] It should be noted that the second regulatory unit is designed to address scenarios where the nervous system itself undergoes positive functional improvements. This change is desired in treatment, indicating that the patient's neurological function is improving. When a state of neurological functional remodeling is identified, the second regulatory unit performs a baseline update operation. The system will use the new baseline as a reference for subsequent comparisons and diagnoses, thereby avoiding repeated false triggering of unnecessary "functional drift" alarms due to continuous improvement in neurological function.

[0087] Understandably, based on the aforementioned differences in physiological and physical mechanisms, this application also provides rigorous theoretical support for the determination of "neural functional remodeling" and the adaptive adjustment of the system. For example, when the neuromodulation system detects that the overall impedance change value is less than or equal to the third threshold (second comparison result), and no functional index deterioration occurs (or even as indicated by the first comparison result, positive signs such as stable target muscle group activation and decreased co-activation appear), the neuromodulation system can accurately determine that: no insulating physical changes have occurred at the electrode-tissue interface, and the patient has undergone positive therapeutic neurofunctional remodeling.

[0088] For the rate of change of activation amplitude of the target muscle group, the rate of change of co-activation degree of non-target muscle groups, the centroid offset vector of the spatial distribution of activated muscle groups, and the overall impedance change value, please refer to the same description in the above embodiments, which will not be repeated here.

[0089] Understandably, when the rate of change of the activation amplitude of the target muscle group is less than or equal to the first threshold, it means that the activation efficiency of the target muscle group has not experienced the continuous decay seen under conditions of tissue interface changes. The rate of change can be a small positive value (slight improvement), close to zero (highly stable), or a small negative value but not exceeding the first threshold.

[0090] A decrease in the rate of change of coactivation in non-target muscle groups can be defined as a negative rate of change of coactivation, with the absolute value exceeding a preset threshold for determining the decrease (e.g., -10%). This indicates that the spatial selectivity of the stimulus is continuously improving, the extent to which the current diffuses to non-target muscle groups is decreasing, and the neural pathways are learning to respond to stimulus signals more precisely.

[0091] When the magnitude of the centroid offset vector is less than or equal to the second threshold, it indicates that the overall activation target remains stable, or although there are slight fluctuations, they are still within an acceptable normal range.

[0092] When the overall impedance change is less than or equal to the third threshold, it indicates that the fiber wrapping around the electrode has not thickened, the tissue edema has not worsened, and the dielectric properties of the conductive medium have not changed in a trend.

[0093] Therefore, the first comparison result indicates that at least one of the above three conditions is met, signifying functional improvement or stabilization. The second comparison result indicates that the overall impedance change is less than or equal to the third threshold, signifying tissue interface stability. Therefore, the condition of neural functional remodeling can be confirmed.

[0094] Understandably, theoretically, impedance stability eliminates interfacial fibrosis interference, allowing functional improvement to be solely attributed to the benign strengthening of synaptic connections within the neural network and the inhibition of pathological generalization. When neural functional remodeling is determined to have occurred, performing a "baseline update operation" is a necessary engineering requirement for dealing with the highly nonlinear, time-varying system of the human nervous system. As the patient's neural function actively improves, their physiological response state has objectively deviated from the pathological baseline at the beginning of treatment. In existing technologies, static baselines often misjudge this "benign deviation" as "functional drift," leading to frequent unnecessary false alarms triggered by the neuromodulation system. The second control unit of this application, by promptly anchoring the currently improved physiological parameters to the new baseline, not only eliminates false positives but also enables the closed-loop system to possess the "adaptive" capability to continuously track the patient's rehabilitation evolution.

[0095] In some embodiments of this application, the control module 105 includes: a touch point update unit, used for: If the first comparison result indicates that the centroid offset vector of the spatial distribution of the activated muscle group is greater than the fourth threshold, the correspondence between multiple touch points and the target muscle group is updated based on the target activation information.

[0096] It should be noted that the fourth threshold is a preset spatial distance threshold used to define the severity of the center of gravity shift that "requires touch-level intervention." In one example, the fourth threshold is greater than the second threshold, indicating that the center of gravity shift first triggers the functional drift warning in the diagnostic logic, and only when the shift worsens further is a touch-level reconfiguration triggered. At this point, a high alert level is reached, indicating that the stimulation target has undergone substantial and unacceptable drift, which cannot be compensated for by adjusting the stimulation parameters in the treatment pulse sequence. Therefore, a "functional repositioning" of the electrode array is required to redetermine the muscle group currently actually controlled by each touch point.

[0097] In some embodiments, the touch update unit includes: The first update subunit is used to determine the actual activated muscle group corresponding to each contact point at the current time based on the target activation information. This information includes the activation distribution of the response induced by each contact point on the multi-channel muscle group after applying a test pulse sequence to each contact point at the target time. Thus, the system determines the actual activated muscle group corresponding to each contact point in terms of function at the current time.

[0098] The second update subunit is used to calculate the activation amplitude of the target muscle group and the co-activation degree of non-target muscle groups for each contact point or combination of contact points. A larger activation amplitude value indicates a better activation effect, and a smaller co-activation degree value indicates a better activation effect. For example, for a combination consisting of contact points A and B, the unit calculates the activation amplitude of the target muscle group and the sum of the activation amplitudes of all recorded non-target muscle groups under stimulation.

[0099] The third update subunit selects the contact point or combination of contact points that maximizes the activation amplitude of the target muscle group and minimizes the co-activation of non-target muscle groups, establishing a correspondence between them and the target muscle group. Based on the evaluation results of the second update subunit, the third update subunit performs an optimal selection. The optimal selection objective is to maximize the activation amplitude of the target muscle group while minimizing the co-activation of non-target muscle groups. In specific implementations, various optimization strategies can be used, such as weighted scoring and maximizing the activation amplitude under a co-activation upper limit constraint, which will not be detailed here.

[0100] In this embodiment, a closed-loop search and matching mechanism is established. Under the new electrode-tissue relative position, by quantifying and weighing the two indicators of "therapeutic effect" and "side effects," the electrical stimulation channel that maximizes the therapeutic effect and minimizes side effects is precisely rediscovered from all possible stimulation sites. This compensates for functional drift while maximizing the maintenance of the system's regulatory or stimulatory effects.

[0101] To further address the safety issue of the new correspondence in actual stimuli after touchpoint remapping, in some embodiments of this application, the control module 105 includes: a touchpoint verification unit, used for: After updating the correspondence between multiple contact points and target muscle groups, electrical stimulation is performed by stimulation electrode 101 according to the test pulse sequence, and verification activation information collected by muscle group acquisition module 102 is obtained; the updated correspondence is verified based on the verification activation information.

[0102] It should be noted that the verification process may include: comparing the activation amplitude of the target muscle group in the activation information with a preset effectiveness threshold to determine whether the effective activation standard has been met; simultaneously, comparing the co-activation degree of non-target muscle groups with a preset safety threshold to determine whether unacceptable side effects will occur. Only when the verification passes, i.e., the new mapping relationship is proven to effectively activate the target while safely controlling side effects, will the new mapping relationship be officially adopted and incorporated into subsequent treatment pulse sequences. If the verification fails, the system may abandon this mapping and re-execute the search, or issue an alarm.

[0103] In this embodiment, an automated functional verification loop is added before the new mapping relationship defined by the software algorithm is formally applied in treatment. This loop simulates the process of a clinician applying a test stimulus to a new stimulation site and observing the patient's response. Through this automated verification, the system can objectively and reliably confirm the feasibility of the new mapping, preventing invalid or even erroneous stimuli due to computational model bias or sudden changes in tissue state, thus greatly ensuring the safety and reliability of the adaptive adjustment process.

[0104] In some embodiments of this application, the adaptive spinal cord nerve modulation system further includes: The message module is used to generate an adjustment message before the control module 105 adjusts the treatment pulse sequence; The communication module is used to send target activation information, target impedance information, multiple items from the first comparison result and the second comparison result, and adjustment messages to an external device; and to receive external pulse sequences sent by the external device. The process of adjusting the treatment pulse sequence by the control module 105 includes updating the treatment pulse sequence stored in the storage module 104 to an external pulse sequence.

[0105] It should be noted that the message module is connected to the control module 105 and is used to generate an adjustment message before the control module 105 prepares to adjust the treatment pulse sequence. This adjustment message can be a structured text or data packet containing information such as the reason for the adjustment, the specific suggested parameter values ​​to be modified, and the functional and impedance indices before and after the modification.

[0106] The communication module, in conjunction with the control module 105 and the message module, is used to transmit some or all of the following information—target activation information, target impedance information, first comparison result, second comparison result, and adjustment message—to an external device (e.g., a doctor's tablet or hospital information system) via a wireless or wired communication protocol. The communication module is also used to wait for and receive external pulse sequences sent back from the external device. For example, this external pulse sequence can be a pulse sequence determined by a professional physician based on data received from the external device, used to achieve compensation.

[0107] Understandably, the adjustment process of the treatment pulse sequence by the control module is no longer a closed loop determined solely by an internal algorithm. Instead, after generating the adjustment message and sending status data, it awaits external confirmation. It updates the current treatment pulse sequence stored in the storage module with an external pulse sequence received from an external device, confirmed or modified by a professional. If the external device sends back an "approved" instruction, the external pulse sequence may match the system's recommended sequence; if the doctor makes manual corrections, the external pulse sequence will differ from the system's recommendation.

[0108] In this embodiment, a secure step involving notification, data sharing, and waiting for external authorization is inserted between the system's intelligent adaptive decision-making and final execution. This allows clinicians to remotely monitor the patient's detailed condition, assess the rationality of the system's diagnosis and recommendations, and possess final decision-making authority, providing crucial security for the fully automated control process.

[0109] For ease of understanding, the adaptive spinal cord nerve modulation system provided in the embodiments of this application will be described below with a specific example.

[0110] Taking a patient with lower limb motor dysfunction due to spinal cord injury as an example, this paper describes the application of the adaptive spinal cord neuromodulation system in long-term rehabilitation. The patient has been implanted with rigid paddle-shaped stimulation electrodes with multiple contacts. The electrodes are located in the epidural space, covering the spinal cord segments that innervate target muscle groups such as the quadriceps femoris.

[0111] During baseline establishment, the stimulating electrodes sequentially apply standardized electrical stimulation to each contact point according to a pre-stored test pulse sequence. The muscle acquisition module simultaneously acquires the compound muscle action potentials evoked by each stimulation using multi-channel surface electromyography (EMG) electrodes attached to the patient's quadriceps femoris muscle and adjacent adductor muscles. The system calculates and stores baseline activation information, which includes the activation amplitude of the target muscle group (quadriceps femoris), the distribution information of co-activated muscle groups, and the coordinates of the activation centroid calculated by weighted averaging of the signal amplitudes from all channels. Simultaneously, the impedance measurement module calculates the impedance values ​​between each contact pair, constructing an inter-electrode impedance relationship matrix reflecting the conductivity of the surrounding cerebrospinal fluid, dura mater, and other tissue media, which is stored as baseline impedance information in the storage module.

[0112] Post-surgery, after a period of time (e.g., three months), the patient returns to the hospital for regular follow-up as instructed by the doctor. The system initiates dual-modal data acquisition, and the stimulating electrodes perform electrical stimulation again with the exact same test pulse sequence as the baseline. The muscle group acquisition module acquires the target activation information at the current target moment, while the impedance measurement module simultaneously measures the target impedance information at the current moment. The control module reads the baseline activation and baseline impedance information from the storage module and calculates the first and second comparison results.

[0113] The first comparison result includes three quantitative indicators: the rate of change in the activation amplitude of the target muscle group, the rate of change in the degree of co-activation of non-target muscle groups, and the centroid offset vector of the spatial distribution of activated muscle groups. The second comparison result includes the overall impedance change value of the target impedance information relative to the baseline impedance information and whether the relative impedance ratio between each contact pair remains stable.

[0114] In this follow-up scenario, the first comparison result showed that the rate of change in quadriceps activation amplitude decreased by approximately 25% compared to baseline, exceeding the preset first threshold; the centroid offset vector of the spatial distribution of activated muscle groups shifted by approximately 6 mm, exceeding the second threshold; and the rate of change in the co-activation degree of non-target muscle groups also increased. The second comparison result showed that the overall impedance change value increased by approximately 20% compared to baseline, exceeding the third threshold, but the distribution pattern of the relative impedance ratio between each contact pair was highly consistent with the baseline period. The control module performed a two-factor differential diagnosis, which determined the current state to be a tissue interface change, specifically manifested as increased impedance at the electrode-tissue interface due to progressive thickening of the fibrous capsule.

[0115] Once the determination is successful, the first control unit generates a stimulus parameter adjustment command. Given the magnitude of the overall impedance increase, the first control unit increases the current intensity in the treatment pulse sequence by 5% to compensate for the attenuation of stimulus energy due to increased tissue resistance, ensuring that the electric field strength required for effective activation is restored at the target nerve tissue.

[0116] After a period of time (e.g., six months), the patient was followed up again. The target activation information collected this time showed: the rate of change in the co-activation degree of non-target muscle groups showed a significant decreasing trend, and the synchronous activation of the adductor muscles was greatly reduced; the rate of change in the activation amplitude of the target muscle groups was stable and slightly increased; the shift of the activation center of gravity remained within a preset small range and showed a characteristic of gradually converging towards the target position. The target impedance information showed that the overall impedance change value fluctuated by only about five percent from the baseline, falling within the third threshold, and the relative impedance ratio between each contact pair remained stable. The modulation module could determine that the current state was neural functional remodeling.

[0117] Once the determination is successful, the second control unit updates the baseline activation information in the storage module to the activation information at the current target time, and updates the baseline impedance information to the impedance information at the current target time.

[0118] Before changing the treatment pulse sequence, the message module generates an adjustment message containing information such as the reason for the adjustment, the suggested parameters to be modified, and the functional and impedance indices before and after the modification. The communication module sends the target activation information, target impedance information, the first comparison result, the second comparison result, and the adjustment message to the doctor's external tablet device via a wireless communication protocol, and waits for the doctor's confirmation. After reviewing the data, the doctor can approve or manually correct it. After receiving the external pulse sequence from the external device, the control module updates the treatment pulse sequence stored in the storage module to the external pulse sequence.

[0119] In this scenario, the system provided in this application significantly improves the stability and precision of long-term neuromodulation therapy for spinal cord injury patients. Patients no longer need to frequently return to the hospital for complex imaging examinations to determine electrode position or interface status; the system automatically identifies the causes of functional drift through bimodal data. When the stimulation effect decreases due to fiber encapsulation, the system automatically increases the stimulation intensity to restore effective activation, avoiding attenuation of treatment effects. When beneficial remodeling of the patient's own neural function occurs, the system can accurately identify and solidify this information, objectively recording rehabilitation progress and avoiding unnecessary parameter fluctuations that could interfere with the rehabilitation process.

[0120] The terms "first," "second," "third," "fourth," "1," "2," etc. (if present) in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in a sequence other than that shown in the illustrations or text descriptions.

[0121] It should be understood that although arrows indicate various operation steps in the flowcharts of this application's embodiments, 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 this application's embodiments, the implementation steps in each flowchart can be executed in other orders as required. Furthermore, some or all steps in each flowchart, based on the actual implementation scenario, may include multiple sub-steps or multiple stages. 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 according to requirements, and this application's embodiments do not limit this.

[0122] The above description is only an optional implementation method for some implementation scenarios of this application. It should be noted that for those skilled in the art, other similar implementation methods based on the technical concept of this application without departing from the technical concept of this application also fall within the protection scope of the embodiments of this application.

Claims

1. An adaptive spinal cord nerve modulation system, characterized in that, include: Stimulation electrodes are implanted into the body of a subject to provide electrical stimulation through multiple contacts. The muscle group acquisition module is used to acquire activation information of the target muscle group of the object after electrical stimulation is performed by the stimulation electrode. An impedance measurement module is used to measure the impedance information between different contacts of the stimulation electrode; The storage module is used to store test pulse sequences, treatment pulse sequences, baseline activation information and baseline impedance information of the object; The control module is used to acquire target activation information and target impedance information, and determine whether the object is in a first situation or a second situation based on a first comparison result and a second comparison result; wherein, the first situation is that the tissue interface in the area where the stimulation electrode is implanted changes; and the second situation is that the target neural tissue targeted by the stimulation electrode undergoes neural function remodeling. The control module is further configured to update the baseline activation information and / or the baseline impedance information when the second condition is determined to occur in the object, and to adjust the treatment pulse sequence when the first condition is determined to occur in the object; The target activation information is the activation information collected by the muscle group acquisition module after the stimulation electrode performs electrical stimulation according to the test pulse sequence at the target time; the target impedance information is the impedance information measured by the impedance measurement module at the target time. The first comparison result is the comparison result between the target activation information and the baseline activation information; the second comparison result is the comparison result between the target impedance information and the baseline impedance information. The activation information includes at least one of the following: activation amplitude of the target muscle group, distribution information of co-activated muscle groups, and coordinates of the activation center of gravity. The first comparison result includes at least one of the following: the rate of change of activation amplitude of the target muscle group, the rate of change of co-activation degree of the non-target muscle group, and the centroid offset vector of the spatial distribution of the activated muscle group.

2. The adaptive spinal cord nerve modulation system according to claim 1, characterized in that, The second comparison result includes: the overall impedance change value of the target impedance information relative to the baseline impedance information, and the relative impedance ratio between each contact pair.

3. The adaptive spinal cord nerve modulation system according to claim 1, characterized in that, The control module includes a first control unit; The first control unit is used to adjust the stimulation parameters in the treatment pulse sequence when the first comparison result and the second comparison result meet a first condition; the first condition includes: The first comparison result indicates that at least one of the following is true: the rate of change of activation amplitude of the target muscle group is greater than the first threshold, the rate of change of co-activation degree of non-target muscle groups is increased, and the centroid offset vector of the spatial distribution of activated muscle groups is greater than the second threshold. The second comparison result indicates that the overall impedance change is greater than the third threshold.

4. The adaptive spinal cord nerve modulation system according to claim 1, characterized in that, The control module includes a second control unit; The second control unit is used to adjust the baseline activation information in the storage module to the target activation information, and / or adjust the baseline impedance information in the storage module to the target impedance information, when the first comparison result and the second comparison result satisfy a second condition: The second condition includes: The first comparison result indicates at least one of the following: the rate of change of activation amplitude of the target muscle group is less than or equal to a first threshold, the rate of change of co-activation degree of non-target muscle groups decreases, and the centroid offset vector of the spatial distribution of activated muscle groups is less than or equal to a second threshold. The second comparison result indicates that the overall impedance change is less than or equal to the third threshold.

5. The adaptive spinal cord nerve modulation system according to claim 3, characterized in that, The stimulation parameters include at least one of the following: pulse width and current intensity.

6. The adaptive spinal cord nerve modulation system according to claim 1, characterized in that, The control module includes: a contact update unit, used for: If the first comparison result indicates that the centroid offset vector of the spatial distribution of the activated muscle group is greater than the fourth threshold, the correspondence between the plurality of touch points and the target muscle group is updated based on the target activation information.

7. The adaptive spinal cord nerve modulation system according to claim 6, characterized in that, The touch update unit includes: The first update subunit is used to determine the actual activated muscle group corresponding to each contact point at the current moment based on the target activation information. The second update subunit is used to calculate the activation amplitude of the target muscle group and the co-activation degree of the non-target muscle group for each contact point or combination of contact points. The third update subunit is used to select the contact point or contact point combination that maximizes the activation amplitude of the target muscle group and minimizes the co-activation degree of the non-target muscle group, and establish a correspondence between it and the target muscle group.

8. The adaptive spinal cord nerve modulation system according to claim 6, characterized in that, The control module includes: a contact verification unit, used for: After updating the correspondence between the multiple contact points and the target muscle group, electrical stimulation is performed through the stimulation electrode according to the test pulse sequence, and the verification activation information collected by the muscle group acquisition module is obtained; the updated correspondence is verified based on the verification activation information.

9. The adaptive spinal cord nerve modulation system according to claim 1, characterized in that, The adaptive spinal cord nerve modulation system also includes: The message module is used to generate an adjustment message before the control module adjusts the treatment pulse sequence; The communication module is used to send the target activation information, the target impedance information, the first comparison result, multiple items in the second comparison result, and the adjustment message to an external device; and to receive an external pulse sequence sent by the external device. The process by which the control module adjusts the treatment pulse sequence includes updating the treatment pulse sequence stored in the storage module to the external pulse sequence.

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