CN-121971802-A - Closed-loop percutaneous spinal cord electric stimulation pain relieving system and method based on physiological feedback

CN121971802ACN 121971802 ACN121971802 ACN 121971802ACN-121971802-A

Abstract

The invention discloses a closed-loop percutaneous spinal cord electric stimulation analgesia system and method based on physiological feedback, and belongs to the field of noninvasive electric stimulation analgesia technology and stimulation control systems thereof. The system comprises an electrode patch, a physiological signal acquisition module, a stimulator, a control module and a closed-loop regulation on the output state of the stimulator, wherein at least one pair of electrode units are integrated on a flexible substrate and used for being attached to a region of a body surface of a subject corresponding to a spinal segment, the physiological signal acquisition module is used for acquiring multi-mode physiological signals of the subject in real time, the stimulator is electrically connected with the electrode patch and used for generating and outputting electrical stimulation signals to the at least one pair of electrode units of the electrode patch, the control module is connected with the physiological signal acquisition module and the stimulator, the pain state of the subject is estimated based on the physiological signals acquired by the physiological signal acquisition module, and the control command is generated according to an estimation result. The system introduces objective feedback, improves adaptability, has noninvasive individuation and simple and convenient operation, and realizes closed-loop automatic control of monitoring, analysis and adjustment.

Inventors

HU LI
Bi Yanzhi
LI NUO
TAN TIANYI
WANG FAGUANG

Assignees

中国科学院心理研究所

Dates

Publication Date: 20260505
Application Date: 20260320

Claims (10)

1. A closed loop transdermal spinal cord electrical stimulation analgesia system based on physiological feedback, comprising: the electrode patch is characterized in that at least one pair of electrode units are integrally arranged on the flexible substrate and are used for being attached to the area of the body surface of the subject corresponding to the spinal segment; The physiological signal acquisition module is used for acquiring the multi-mode physiological signals of the subject in real time; The stimulator is electrically connected with the electrode patch and is used for generating and outputting an electric stimulation signal to at least one pair of electrode units of the electrode patch; the control module is connected with the physiological signal acquisition module and the stimulator, evaluates the pain state of the subject based on the physiological signal acquired by the physiological signal acquisition module, and generates a control instruction to carry out closed-loop adjustment on the output state of the stimulator according to the evaluation result.
2. The system of claim 1, wherein the physiological signal acquired by the physiological signal acquisition module comprises at least one of myoelectricity, electroencephalogram, and electrocardiographic signals.
3. The system of claim 1, wherein the closed loop adjustment comprises automatically controlling the turning on, off of the electrical stimulation or the adjustment of stimulation parameters including frequency, amperage, pulse width, and stimulation duration.
4. The system of claim 1, wherein the electrode elements of the electrode patch are made of a flexible material, and the conductive portions thereof are Ag/AgCl or a conductive hydrogel material.
5. The system of claim 1, wherein the stimulator comprises: the DDS module is used for generating an electric signal corresponding to a preset waveform for at least one pair of electrode units according to the instruction of the control module; The operational amplifier module is connected with the DDS module and used for conditioning, amplifying voltage and matching impedance of the generated electric signals; And the power amplifier module is connected with the operational amplifier module and is used for converting the amplified electric signal into a constant-current stimulation signal and outputting the constant-current stimulation signal to at least one pair of corresponding electrode units.
6. The system of claim 1, wherein the control module comprises a main controller, and a display module, a keyboard module and a storage module respectively connected with the main controller; The main controller is used for establishing an individualized baseline data or pain biomarker model based on the acquired physiological signals before the stimulation starts, wherein the evaluation comprises the comparison of the real-time physiological signals with the baseline data or model, and the analysis of the stimulation parameter instructions can configure and simultaneously activate at least one pair of corresponding electrode units so as to realize the joint stimulation or the distributed stimulation of a plurality of spinal segments; The display module is used for displaying the working state of the system, the configuration information of the electrode unit, the stimulation parameter information and the multi-mode physiological signal information; the keyboard module is used for receiving operation instructions of a user, and comprises a selection of electrode combinations, an increase and decrease of the stimulation intensity adjustment, a switching of different stimulation modes and a stimulation parameter instruction for starting or stopping stimulation treatment; the storage module is used for storing a stimulation parameter scheme, an electrode combination scheme, physiological signal baseline data and system operation data.
7. The system of claim 6, wherein the master controller is configured to evaluate the pain state by determining whether a characteristic value of the real-time physiological signal exceeds a threshold value set based on the baseline data or model.
8. A closed-loop percutaneous spinal cord electric stimulation analgesia method based on physiological feedback, which is characterized in that the closed-loop percutaneous spinal cord electric stimulation analgesia system based on physiological feedback as claimed in any one of claims 1-7 is used, and the method comprises the following steps: step S1, collecting physiological signals of a subject, and establishing an individual pain evaluation reference; Step S2, applying percutaneous electrical stimulation to the target spinal cord segment through the electrode patch; step S3, physiological signals of a subject are collected in real time in the stimulation process; S4, comparing and analyzing the physiological signals acquired in real time with the personalized pain assessment standard, and judging the pain state change of the subject; step S5, automatically adjusting the output state of the percutaneous electrical stimulation based on the analysis result; And S6, repeating the steps S2 to S5 until the stimulation is finished.
9. The method according to claim 8, wherein in step S1, the establishing of the personalized pain assessment reference comprises the steps of collecting physiological signals and corresponding subjective scores of the subject at different pain degrees, and constructing a mapping relation from physiological signal characteristics to pain intensity through a machine learning model.
10. The method of claim 8, wherein step S5 comprises: triggering adjustments, including adaptive adjustment of stimulation parameters, to match the subject's real-time pain state, if the physiological signal deviates from baseline by more than a preset range.

Description

Closed-loop percutaneous spinal cord electric stimulation pain relieving system and method based on physiological feedback Technical Field The invention relates to the technical fields of biomedical engineering and rehabilitation medical treatment, in particular to a closed-loop percutaneous spinal cord electro-stimulation analgesia system and method based on physiological feedback, which are used for optimally adjusting an analgesia scheme. Background Pain is one of the most common and challenging health problems in the clinic, and is widely found in various disease states such as low back pain, neuropathic pain, postoperative pain, and chronic pain. Pain that occurs for a long period or repeatedly affects not only the quality of life and functional status of the patient, but also causes psychological problems such as anxiety, depression, etc., resulting in significant social and economic burden. At present, the treatment means of the pain mainly comprise modes of drug treatment, physical treatment, interventional nerve regulation and control and the like. Among them, the drug therapy, especially opioid, can alleviate pain to some extent, but it is easy to produce tolerance, dependency and various adverse reactions after long-term use, which limits its clinical application. Spinal cord electrical stimulation (Spinal Cord Stimulation, SCS) has been widely used as a neuromodulation technique for modulating pain signaling pathways by applying electrical stimulation to spinal cord-related segments. However, the traditional implanted spinal cord electrical stimulation system generally needs an implanted electrode and a stimulator in a surgery, has the problems of strong invasiveness, high cost, high surgery risk and the like, and limits the popularization and application of the system in partial patients. In recent years, percutaneous spinal cord electrical stimulation (Transcutaneous Spinal Cord Stimulation, TSCS) has received attention as a non-invasive or minimally invasive alternative that stimulates spinal cord segments through body surface electrodes, exhibiting some potential in analgesia and functional regulation. The existing percutaneous spinal cord electric stimulation system mostly adopts an open-loop stimulation mode with preset parameters, namely stimulation frequency, intensity and stimulation duration are usually set by an operator according to experience or subjective feedback of a patient, and dynamic monitoring and adjustment of real-time physiological state and pain change of an individual are lacked in the stimulation process. The open loop control mode is difficult to deal with the dynamic change of pain states of different individuals and the same individual at different time points, and the problems of limited analgesic effect caused by insufficient stimulation or discomfort and even adverse reaction caused by excessive stimulation are easy to occur. Meanwhile, the subjective pain scores of patients are relied on for adjustment, and the defects of strong subjectivity, poor instantaneity, complex operation flow and the like exist. Along with the development of physiological signal acquisition and intelligent control technology, objective physiological indexes such as myoelectricity (EMG), electroencephalogram (EEG), electrocardio (ECG) and the like are considered to be closely related to pain perception and autonomic nerve activity, and can be used for reflecting the pain state and stress level of an individual. However, there is a lack of a closed loop analgesic system in the prior art that introduces a multi-modal physiological signal in real time into the percutaneous spinal cord electrical stimulation regulation process and that enables automatic adjustment of the stimulation parameters or stimulation conditions based on physiological feedback. Therefore, there is a need for a closed-loop analgesic system and method capable of performing real-time and personalized regulation and control on percutaneous spinal cord electrical stimulation in combination with objective physiological feedback information, so as to improve stability and safety of analgesic effect, reduce dependence on artificial experience and subjective evaluation, simplify clinical operation flow, and expand application value of percutaneous spinal cord electrical stimulation in the field of pain treatment. Disclosure of Invention The invention aims to provide a closed-loop percutaneous spinal cord electric stimulation analgesia system and method based on physiological feedback, which can solve the problems that the existing electric stimulation system lacks real-time feedback, relies on subjective judgment, has rough stimulation parameters, is complex to operate and the like. In order to achieve the above purpose, the present invention adopts the following technical scheme: In a first aspect, embodiments of the present invention provide a closed loop transdermal spinal cord electrical stimulation analgesia system based