A closed-loop multi-channel multi-mode time-domain interference electrical stimulation system and method

Abstract

The present invention relates to a closed-loop multi-channel multi-mode time-domain interference electrical stimulation system and method, the system includes: a software part determines stimulation parameters; an electrode position automatic adjustment device adjusts the spatial position of a multi-channel electrode device, and the multi-channel electrode device stimulates the target position; a current output accuracy and impedance monitoring module monitors the accuracy and impedance information of the electrode output current, and a core main control and functional circuit module adjusts the control signal accordingly; when the multi-channel electrode device stimulates, an electroencephalogram device synchronously collects electroencephalogram signals and uploads them to an electroencephalogram analysis algorithm module of the software part, and the electroencephalogram analysis algorithm module evaluates and feeds back the effectiveness and effect of the stimulation, and a time-domain interference electrical stimulation function module and a target area dynamic adjustment algorithm module optimize the stimulation parameters accordingly. Through the above-mentioned settings, a real-time closed-loop feedback control system is formed to realize continuous monitoring, real-time optimization and adjustment of electrical stimulation parameters and dynamic adjustment of the stimulated brain target area, thereby ensuring the accuracy and safety of current output.

Description

Technical Field

[0001] The present invention relates to the field of medical equipment technology, and in particular to a closed-loop multi-conductor multi-mode time-domain interference electrical stimulation system and method. Background Art

[0002] Deep brain stimulation (DBS) is more effective than related drug treatments for many neurological and psychiatric diseases, such as Parkinson's disease, idiopathic concussion, dystonia and obsessive-compulsive disorder. DBS uses traditional implanted electrodes to apply electric current to the human body, thereby regulating the function of neural circuits and related brain regions. The key to the success of deep brain stimulation is that it has high resolution in both time and space, which can prevent accidental excitation of other neurons while stimulating the target neurons.

[0003] However, traditional implantable electrodes require the implantation of electrodes and related electrical stimulation devices (batteries, etc.) in the body through precise surgical procedures, which are accompanied by high-cost craniotomy, high infection rates, limited battery life, low flexibility, and other disadvantages. Non-invasive transcranial electrical stimulation methods have emerged. Transcranial electrical stimulation methods only require the placement of electrodes on the surface of the scalp to apply current to change the excitability of neurons on the surface of the cerebral cortex. However, a large number of studies have shown that transcranial electrical stimulation can stimulate superficial brain areas such as the cerebral cortex, but the current cannot reach nerves deep in the human body, and the stimulation accuracy is far lower than that of traditional implantable electrodes.

[0004] As an emerging brain nerve regulation technology, time-domain interferometric electrical stimulation (TI) technology applies two high-frequency currents with a frequency difference on the scalp surface, and uses the principle of interference to form a difference-frequency envelope electric field in a specific area inside the brain, thereby achieving precise deep brain stimulation without affecting superficial cortical activity. It is non-invasive and can perform deep brain stimulation regulation.

[0005] In the actual application of time-domain interferometric electrical stimulation technology, due to the influence of various factors between different individuals, such as age, gender, basic health status, individual differences in brain physiological structure, and pathological characteristics of specific diseases, the brain's response to electrical stimulation shows significant diversity and complexity. Such individual differences make it difficult for fixed stimulation parameter schemes to be universally applicable to all individuals. If inappropriate stimulation parameters are used without fully considering individual differences, a series of adverse reactions may be triggered in patients, which will not only make it difficult to achieve the expected stimulation effect and effectively improve the symptoms of the disease, but also may cause adverse reactions such as headaches, dizziness, nausea, visual or auditory abnormalities due to inappropriate stimulation of neural tissue, and even in severe cases may affect the normal function of the brain, posing potential safety hazards. Summary of the invention

[0006] In order to solve the above-mentioned defects, the present invention proposes a closed-loop multi-channel multi-mode time-domain interference electrical stimulation system and method.

[0007] The technical solution adopted by the present invention is a closed-loop multi-channel multi-mode time-domain interference electrical stimulation system, comprising:

[0008] A software part, comprising a time domain interference electrical stimulation function module, wherein the software part acquires a target point position, the time domain interference electrical stimulation function module determines stimulation parameters according to the target point position, and the software part issues stimulation instructions according to the stimulation parameters;

[0009] A core main control and functional circuit module, whose signal is connected to the software part, the core main control and functional circuit module receives the stimulation instruction issued by the software part and parses it, and the core main control and functional circuit module outputs the parsed control signal;

[0010] An electrode position automatic adjustment device, whose signal is connected to the core main control and functional circuit module, and the electrode position automatic adjustment device receives the control signal output by the core main control and functional circuit module;

[0011] A multi-electrode device, whose signal is connected to the electrode position automatic adjustment device, the electrode position automatic adjustment device adjusts the spatial position of the multi-electrode device according to the control signal, and the multi-electrode device stimulates the target position on the human scalp under the stimulation parameters according to the control signal;

[0012] A current output accuracy and impedance monitoring module is respectively connected to the multi-conducting electrode device and the core main control and functional circuit module by signals. The current output accuracy and impedance monitoring module monitors the accuracy and impedance information of the electrode output current of the multi-conducting electrode device, and transmits the accuracy and impedance information to the core main control and functional circuit module. The core main control and functional circuit module adjusts the control signal according to the accuracy and impedance information.

[0013] Preferably, it also includes an electroencephalogram device, which synchronously collects electroencephalogram signals when the multi-electrode device stimulates, and uploads the electroencephalogram signals to the software part;

[0014] The software part also includes an EEG analysis algorithm module, which receives the EEG signal transmitted by the EEG device, evaluates the effectiveness and effect of the stimulation based on the EEG signal, and obtains the evaluation result.

[0015] Preferably, the software part further includes a target area dynamic adjustment algorithm module, and the time domain interference electrical stimulation function module, the EEG analysis algorithm module and the target area dynamic adjustment algorithm module are signal-connected in pairs;

[0016] The EEG analysis algorithm module feeds back the evaluation result to the time domain interference electrical stimulation function module and the target area dynamic adjustment algorithm module, and the time domain interference electrical stimulation function module and the target area dynamic adjustment algorithm module optimize the stimulation parameters in real time.

[0017] Preferably, the stimulation parameters include stimulation current, stimulation frequency, stimulation time, TI mode and electrode position;

[0018] The time domain interference electrical stimulation function module optimizes the stimulation current, stimulation frequency, and stimulation time, and the target area dynamic adjustment algorithm module optimizes the TI mode and electrode position.

[0019] Preferably, the electrode position automatic adjustment device comprises:

[0020] A main control and core circuit module, whose signal is connected to the core main control and functional circuit module, and the main control and core circuit module receives the control signal output by the core main control and functional circuit module, and analyzes the control signal to obtain the next level control signal;

[0021] A mechanical electric control device, whose signal is connected to the main control and core circuit modules, and adjusts the spatial position of the multi-electrode device according to the next level control signal.

[0022] Preferably, the mechanical electric control device comprises:

[0023] A main control device, which receives the next level control signal;

[0024] A mechanical support channel, whose signal is connected to the main control device, and the main control device mobilizes the mechanical support channel according to the next level control signal to adjust the spatial position of the multi-conductive electrode device;

[0025] An electrical signal transmission channel, whose signal is connected to the main control device, and the next-level control signal of the main control device is transmitted to the multi-electrode device through the electrical signal transmission channel, and the multi-electrode device stimulates the target position on the human scalp under the stimulation parameters according to the next-level control signal.

[0026] Preferably, the mechanical electric control device further comprises a position sensor, and the position sensor monitors the position information of the multi-electrode device in real time;

[0027] The electrode position automatic adjustment device also includes a position sensor signal processing module connected to the mechanical electric control device signal, the position sensor signal processing module receives the position information, and optimizes the mechanical electric control device to adjust the spatial position of the multi-conductive electrode device according to the position information.

[0028] The present invention also provides a closed-loop multi-channel multi-mode time-domain interference electrical stimulation method. Based on the above-mentioned closed-loop multi-channel multi-mode time-domain interference electrical stimulation system, the method comprises the following steps:

[0029] S10, obtaining stimulation parameters, and issuing stimulation instructions according to the stimulation parameters;

[0030] S20, parsing the stimulation instruction issued in S10, and outputting the parsed control signal;

[0031] S30, stimulating the human scalp according to the control signal outputted from S20;

[0032] S40, monitoring the accuracy and impedance information of the output current when S30 stimulates the human scalp, adjusting the control signal output by S20 according to the accuracy and impedance information, and repeating S30 to S40.

[0033] Preferably, after S30, the step further includes:

[0034] S50, collecting the EEG signal during the stimulation in S30, adjusting the stimulation parameters obtained in S10 according to the EEG signal, and repeating S20 to S40.

[0035] Preferably, after S50, the step further includes:

[0036] S60, evaluating the effectiveness and effect of the stimulation according to the EEG signal collected in S50, and stopping the stimulation if the effectiveness and effect of the stimulation meet expectations.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] 1. After the EEG analysis algorithm module analyzes the EEG signals collected in real time, it feeds back the evaluation results to the time-domain interference electrical stimulation function module and the target area dynamic adjustment algorithm module. The time-domain interference electrical stimulation function module and the target area dynamic adjustment algorithm module can optimize the stimulation parameters in real time. The multi-module linkage and real-time closed-loop feedback mechanism in the system make the electrical stimulation treatment process more intelligent, precise and personalized. The target area dynamic adjustment algorithm module ensures that the current is concentrated in the target area, reduces the impact on non-target areas, and makes the electrical stimulation more accurate. Combined with the stimulation parameters optimized by the time-domain interference electrical stimulation function module, the system can achieve the treatment effect more efficiently and ensure stable efficacy. Through dynamic adjustment and multi-level optimization, this embodiment effectively solves the problems of real-time optimization of stimulation parameters, dynamic selection of stimulation targets and accuracy in traditional time-domain interference electrical stimulation systems, and improves the application effect and safety of time-domain interference electrical stimulation in the fields of neuroregulation and rehabilitation.

[0039] 2. The closed-loop multi-conductor multi-mode time-domain interference electrical stimulation system in the present invention includes a multi-conductor electrode device, a current output accuracy and impedance monitoring module, and a core main control and functional circuit module, forming a real-time closed-loop feedback control system. Through closed-loop feedback control, the system can realize continuous monitoring, real-time optimization and adjustment of electrical stimulation parameters, ensure the accuracy and safety of current output, avoid adverse effects on stimulation effects due to current fluctuations or impedance changes, ensure the safety and effectiveness of the entire electrical stimulation process, and provide more accurate and personalized electrical stimulation treatment or research in the fields of medical and scientific research.

[0040] 3. In the multi-channel mode, multiple stimulation electrodes can simultaneously generate multiple time-domain interference electric fields in different areas of the brain, forming a more complex and precise interference electric field distribution, and stimulate multiple deep areas of the brain at the same time, thereby more comprehensively regulating the brain's neural activity; in the multi-channel mode, multiple acquisition electrodes can simultaneously collect EEG signals from multiple different scalp locations, capturing more comprehensive brain activity data, making it easier for the time-domain interference electrical stimulation function module and the target area dynamic adjustment algorithm module to more accurately optimize the stimulation parameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The present invention is described in detail below with reference to the embodiments and accompanying drawings, wherein:

[0042] Figure 1 It is a block diagram of the structure of a closed-loop multi-channel multi-mode time-domain interferometric electrical stimulation system;

[0043] Figure 2 It is a structural block diagram of an electrode position automatic adjustment device;

[0044] Figure 3 It is a schematic diagram of a mechanical and electrical control device;

[0045] Figure 4 It is a flow chart of a closed-loop multi-channel multi-mode time-domain interferometric electrical stimulation method;

[0046] Figure 5 It is the distribution diagram of TI envelope when the current of the two electrodes is 5mA, 2000Hz and 5mA, 2010Hz respectively in parallel conduction mode;

[0047] Figure 6 It is the distribution diagram of TI envelope when the current of the two electrodes is 5mA, 2000Hz and 1mA, 2010Hz respectively in parallel conduction mode;

[0048] Figure 7 This is the distribution diagram of TI envelope when the currents of the two electrodes are 5mA, 2000Hz and 5mA, 2010Hz respectively in parallel conduction mode, and the distances are different;

[0049] Figure 8 This is the distribution diagram of TI envelope when the currents of the two electrodes are 5mA, 2000Hz and 5mA, 2010Hz respectively in parallel conduction mode, and the distance difference increases;

[0050] Fig. 9 In the parallel conduction mode, the currents of the two conduction electrodes were 1 mA, 2000 Hz and 5 mA, 2010 Hz, respectively, and the distance was increased with difference, and the distribution diagram of the TI envelope when the two conduction excitations were inconsistent was superimposed;

[0051] Fig.10 It is the distribution diagram of TI envelope when the current of the two electrodes is 5mA, 2000Hz and 5mA, 2010Hz respectively in the cross-conduction mode.

[0052] 100. Software part; 110. Target area dynamic adjustment algorithm module; 120. Time domain interference electrical stimulation function module; 130. EEG analysis algorithm module;

[0053] 200. Core main control and functional circuit module;

[0054] 300, electrode position automatic adjustment device; 310, main control and core circuit module; 320, mechanical electric control device; 321, main control device; 322, mechanical support channel; 323, electrical signal transmission channel; 324, multi-channel stimulation electrode and position sensor; 330, position sensor signal processing module;

[0055] 400. Multi-electrode device;

[0056] 500. Current output accuracy and impedance monitoring module. DETAILED DESCRIPTION

[0057] In order to make the purpose, technical scheme and advantages of the present invention clearer, the embodiments of the present invention will be further described in detail below in conjunction with the accompanying drawings. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar components or components with the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be interpreted as limiting the present invention.

[0058] In one embodiment, a closed-loop multi-channel multi-mode time-domain interferometric electrical stimulation system, such as Figure 1 As shown, it includes a software part 100, a core main control and functional circuit module 200, an electrode position automatic adjustment device 300, a multi-conductive electrode device 400 and a current output accuracy and impedance monitoring module 500.

[0059] The software part 100 obtains the target position, which refers to the position of a specific neural area in the three-dimensional structure of the brain that is determined to require electrical stimulation intervention. For different neurological and psychiatric diseases, the root of the lesions may exist in specific brain areas. For example, in Parkinson's disease, deep brain structures such as the subthalamic nucleus and the internal nucleus of the globus pallidus are often used as treatment targets; in the treatment of obsessive-compulsive disorder, brain areas such as the orbitofrontal cortex and the anterior cingulate gyrus may be key intervention sites. Therefore, the target position is a carefully selected internal brain area based on the understanding of the pathogenesis of the disease and the functional anatomy of the brain. Before implementing the stimulation, the user or system operator can preliminarily select the target position on the three-dimensional human head model through the software interface. The target position is usually based on clinical experience or the preset of the target stimulation area, combined with the specific physiological or functional needs of the target for preliminary selection. The software part 100 includes a time domain interference electrical stimulation function module 120, which determines stimulation parameters such as current intensity, frequency, stimulation mode (such as parallel conduction or cross conduction), stimulation time, etc. according to the target position, and then the software part 100 sends stimulation instructions to the core main control and functional circuit module 200 according to the stimulation parameters.

[0060] Among them, the time domain interference electrical stimulation function module 120 is mainly responsible for generating and regulating electrical stimulation signals, realizing the control of electrical stimulation waveforms, frequencies and modes in the time domain, so that the stimulation signals of multiple current derivation channels interfere with each other in the target area to achieve specific neuromodulation or therapeutic effects. It can specifically include a signal generation unit, a frequency and phase control unit, and an intensity and mode control unit. The signal generation unit generates multiple sinusoidal current signals of different frequencies; the frequency and phase control unit controls the frequency, phase and amplitude of the output signal to form an interference wave, thereby generating a low-frequency interference signal; the intensity and mode control unit adjusts the intensity of the output current and selects a stimulation mode (such as parallel conduction or cross conduction) to achieve different spatial interference effects. The specific units included in the time domain interference electrical stimulation function module 120 can be increased or decreased according to actual needs.

[0061] The core main control and functional circuit module 200 is responsible for managing and coordinating the operations of each hardware module, and processing the instructions of the software part 100 to achieve precise electrical stimulation control, and its signal is connected to the software part 100. The core main control and functional circuit module 200 receives and parses the stimulation instructions issued by the software part 100, and the core main control and functional circuit module 200 converts the parsed instructions into control signals executable by the hardware and outputs them. The core main control and functional circuit module 200 may specifically include a main control processor, a signal analysis unit, a current regulation unit, a frequency control unit, a phase adjustment unit, a signal conditioning and amplification circuit, etc. The main control processor, such as a high-performance microprocessor or a digital signal processor (DSP), is used for instruction analysis, control signal generation and data processing; the signal analysis unit analyzes the stimulation instructions from the software part 100, and decomposes the high-level instructions into specific control parameters, such as stimulation current intensity, frequency, phase difference, etc.; the current regulation unit adjusts the current output according to the stimulation instructions to meet different stimulation intensity requirements; the frequency control unit generates current signals of different frequencies to meet the frequency requirements of time domain interference electrical stimulation, ensuring that the electrical stimulation frequency and phase difference meet the set interference mode; the phase adjustment unit adjusts the phase difference of different channels to produce a time domain interference effect so that the current is focused at the target position; the signal conditioning and amplification circuit conditions and amplifies the output signal to meet the stimulation requirements of the multi-electrode device 400.

[0062] The electrode position automatic adjustment device 300 is used for spatial adjustment of the electrode position. Its signal is connected to the core main control and functional circuit module 200. The electrode position automatic adjustment device 300 receives the control signal output by the core main control and functional circuit module 200, and adjusts the position of the multi-conductive electrode device 400 in three-dimensional space according to the control signal issued by the core main control and functional circuit module 200. The electrode position automatic adjustment device 300 ensures that the stimulation current directly acts on the target area by accurately adjusting the position of the electrode in three-dimensional space, thereby improving the accuracy of stimulation.

[0063] The multi-conductor electrode device 400 is composed of multiple electrodes, which can output electrical stimulation according to the control signal and is responsible for executing the final electrical stimulation. The multi-conductor electrode device 400 is connected to the electrode position automatic adjustment device 300 by signal, and the electrode position automatic adjustment device 300 adjusts the spatial position of the multi-conductor electrode device 400 according to the control signal, and the multi-conductor electrode device 400 stimulates the target position on the human scalp under the stimulation parameters according to the control signal. The multi-conductor electrode device 400 realizes the multi-conductor and multi-mode stimulation function, and can apply precise stimulation to the designated target point to improve the effect of treatment or experiment.

[0064] The current output accuracy and impedance monitoring module 500 includes a current monitoring unit, an impedance measurement unit, etc., to monitor the current output accuracy and impedance of the electrode. The current output accuracy and impedance monitoring module 500 are respectively connected to the multi-conducting electrode device 400 and the core main control and functional circuit module 200. The current output accuracy and impedance monitoring module 500 monitors the accuracy and impedance information of the electrode output current of the multi-conducting electrode device 400, and transmits the accuracy and impedance information to the core main control and functional circuit module 200. The core main control and functional circuit module 200 dynamically adjusts the control signal according to the accuracy and impedance information to ensure the accuracy and safety of the current output. A monitoring and feedback loop is formed between the current output accuracy and impedance monitoring module 500 and the multi-conducting electrode device 400 and the core main control and functional circuit module 200 to ensure that the current output meets the set requirements.

[0065] The closed-loop multi-conductor multi-mode time-domain interference electrical stimulation system in this embodiment includes a multi-conductor electrode device 400, a current output accuracy and impedance monitoring module 500, and a core main control and functional circuit module 200, forming a real-time closed-loop feedback control system. Through closed-loop feedback control, the system can realize continuous monitoring, real-time optimization and adjustment of electrical stimulation parameters, ensure the accuracy and safety of current output, avoid adverse effects on stimulation effects due to current fluctuations or impedance changes, ensure the safety and effectiveness of the entire electrical stimulation process, and provide more accurate and personalized electrical stimulation treatment or research in fields such as medical care and scientific research.

[0066] In one embodiment, the closed-loop multi-channel multi-mode time-domain interference electrical stimulation system also includes an electroencephalogram (EEG) device, which is used to collect EEG signals and upload the EEG signals to the software part 100. The electroencephalogram (EEG) device mainly includes electrodes and data transmission interfaces. The electrodes are used to collect the brain wave activity (EEG) of the subject during the electrical stimulation process, and transmit the EEG signals to the software part 100 of the system through the data interface, providing basic data support for subsequent effect evaluation and feedback. Specifically, the electrodes can be electrodes in the multi-channel electrode device 400, which can be used for electrical stimulation of the target area of ​​the human head and for collecting EEG signals after stimulation, thereby achieving a high degree of synchronization between stimulation and signal collection in time and space. The software part 100 also includes an electroencephalogram (EEG) analysis algorithm module 130, which receives the EEG signals transmitted by the electroencephalogram (EEG) device. The EEG analysis algorithm module 130 analyzes and processes the collected EEG signals based on the algorithm to extract relevant biological features and quantify the effect and effectiveness of the stimulation. The specific evaluation includes the analysis of the spectrum, amplitude and other characteristics of the EEG waves to determine whether the stimulation has produced the expected neural response. The EEG analysis algorithm module 130 can generate an evaluation result based on the EEG signal analysis and evaluation of the effectiveness and effect of the stimulation. Based on the evaluation result, the system can verify whether the expected neural response or physiological effect has been achieved. The EEG device can be directly integrated into the closed-loop multi-channel multi-mode time-domain interference electrical stimulation system in the aforementioned embodiment without the need for additional equipment. Specifically, the electrodes in the multi-channel electrode device 400 collect EEG signals, and then transmit the EEG signals to the EEG analysis algorithm module 130 of the software part, without the need for additional electrodes and data transmission channels, making the hardware layout of the entire system more compact and concise, reducing possible failure points due to equipment compatibility, signal transmission matching and other issues, and improving the overall stability and reliability of the system.

[0067] In the process of actual use of time domain interference electrical stimulation technology, it is necessary to accurately lock a specific target area to avoid interference with non-target areas. However, brain activity is dynamic, and the activity state of certain functional areas changes over time, so it is particularly important to dynamically adjust the target during stimulation. Therefore, in one embodiment, the software part 100 also includes a target area dynamic adjustment algorithm module 110, and the time domain interference electrical stimulation function module 120, the EEG analysis algorithm module 130 and the target area dynamic adjustment algorithm module 110 are connected in pairs, and information sharing and feedback optimization are realized through a two-way signal connection between them. Specifically, when the multi-electrode device stimulates, the EEG device synchronously collects EEG signals, and the EEG analysis algorithm module 130 analyzes the EEG signals collected in real time, and then feeds back the evaluation results to the time domain interference electrical stimulation function module 120 and the target area dynamic adjustment algorithm module 110, and the time domain interference electrical stimulation function module 120 and the target area dynamic adjustment algorithm module 110 optimize the stimulation parameters in real time.

[0068] Among them, the stimulation parameters include stimulation current, stimulation frequency, stimulation time, TI mode and electrode position. TI mode refers to interference mode, including parallel conduction and cross conduction. The time domain interference electrical stimulation function module 120 optimizes the stimulation current, stimulation frequency, and stimulation time, and dynamically adjusts the stimulation parameters to achieve precise electrical stimulation. The target area dynamic adjustment algorithm module 110 optimizes the TI mode and electrode position, dynamically adjusts the target area position, ensures the spatial accuracy of the stimulation, enables the current to be more focused on the target area, and reduces the impact on non-target areas. The two complement each other in the optimization process to ensure that the stimulation space and parameters are in line with the treatment goals.

[0069] The multi-module linkage and real-time closed-loop feedback mechanism in the system of this embodiment make the electrical stimulation treatment process more intelligent, precise and personalized. The target area dynamic adjustment algorithm module 110 ensures that the current is concentrated in the target area, reduces the impact on non-target areas, and makes the electrical stimulation more accurate. Combined with the stimulation parameters optimized by the time domain interference electrical stimulation function module 120, the system can achieve the treatment effect more efficiently and ensure stable efficacy. Through dynamic adjustment and multi-level optimization, this embodiment effectively solves the problems of real-time optimization of stimulation parameters and dynamic selection of stimulation targets and accuracy in traditional time domain interference electrical stimulation systems, and improves the application effect and safety of time domain interference electrical stimulation in the fields of neuroregulation and rehabilitation.

[0070] In one embodiment, the multi-conductor electrode device 400 is composed of multiple stimulation electrodes and multiple collection electrodes, multiple stimulation electrodes are used for electrical stimulation, and multiple collection electrodes can be used for EEG collection, so that the multi-conductor electrode device 400 can support multi-channel EEG collection and electrical stimulation, and EEG collection and electrical stimulation can be performed simultaneously. In the multi-conductor mode, multiple stimulation electrodes can simultaneously generate multiple time-domain interference electric fields in different areas of the brain, forming a more complex and accurate interference electric field distribution, and stimulate multiple deep areas of the brain at the same time, thereby more comprehensively regulating the neural activity of the brain. In the multi-conductor mode, multiple collection electrodes can collect EEG signals from multiple different scalp positions at the same time, capture more comprehensive brain activity data, and facilitate the time-domain interference electrical stimulation function module 120 and the target area dynamic adjustment algorithm module 110 to more accurately optimize the stimulation parameters.

[0071] In one embodiment, Figure 2As shown, the electrode position automatic adjustment device 300 includes a main control and core circuit module 310 and a mechanical electric control device 320. The main control and core circuit module 310 is connected to the core main control and functional circuit module 200 by signal. The main control and core circuit module 310 receives the control signal output by the core main control and functional circuit module 200, and parses and conditions the control signal into a next-level control signal suitable for the mechanical electric control device 320. The conditioning process may include filtering, amplifying, and smoothing the signal, or adjusting the frequency and voltage of the signal to ensure that the signal quality is stable and suitable for the processing or output requirements of the next level. The mechanical electric control device 320 is connected to the main control and core circuit module 310 by signal, and adjusts the spatial position of the multi-conductive electrode device 400 according to the next-level control signal. The structure of multi-level signal analysis can gradually decompose the complex control signal, ensure that the instruction transmission of the electrode adjustment is accurate, and improve the accuracy of electrode positioning and the real-time performance of adjustment.

[0072] In one embodiment, Figure 3 As shown, the mechanical electric control device 320 includes a main control device 321, a mechanical support channel 322 and an electrical signal transmission channel 323. The mechanical support channel 322 and the electrical signal transmission channel 323 refer to Figure 3 Several vertical lines in it. The main control device 321 receives the next level control signal, and regulates the mechanical support channel 322 and the electrical signal transmission channel 323 according to the signal. The mechanical support channel 322 signal is connected to the main control device 321. The main control device 321 mobilizes the mechanical support channel 322 according to the next level control signal to adjust the spatial position of the multi-conductive electrode device 400. The mechanical support channel 322 is responsible for the actual physical support and position adjustment to ensure that the multi-conductive electrode can reach the target position according to the instruction. The electrical signal transmission channel 323 signal is connected to the main control device 321. The next level control signal of the main control device 321 is transmitted to the multi-conductive electrode device 400 through the electrical signal transmission channel 323. The multi-conductive electrode device 400 stimulates the target position on the human scalp under the stimulation parameters according to the next level control signal.

[0073] The main control device 321 distributes the received next-level control signal to the mechanical support channel 322 and the electrical signal transmission channel 323 to respectively perform the electrode position adjustment and signal transmission. The mechanical support channel 322 adjusts the position of the electrode, and the electrical signal transmission channel 323 is responsible for providing the stimulation signal, thereby achieving precise electrical stimulation of the target area. The division of labor and cooperation between the mechanical support channel 322 and the electrical signal transmission channel 323 enables the system to accurately control the spatial position of the multi-conducting electrode and efficiently transmit electrical signals, which helps to enhance the stability and response speed of the system and improve the accuracy of electrical stimulation.

[0074] In one embodiment, the mechanical electric control device 320 also includes a position sensor, which monitors the position information of the multi-conducting electrode device 400 in real time and transmits the position information to the position sensor signal processing module 330. The electrode position automatic adjustment device 300 also includes a position sensor signal processing module 330 connected to the mechanical electric control device 320 signal. The position sensor signal processing module 330 receives the position information and optimizes the adjustment of the spatial position of the multi-conducting electrode device 400 by the mechanical electric control device 320 according to the position information, so that the multi-conducting electrode device 400 remains in the optimal position. The position sensor signal processing module 330 can also upload the position information of the electrode, and the target area dynamic adjustment algorithm module 110 can further accurately control the position of the stimulation electrode. Further, as Figure 3 As shown, the multi-channel stimulation electrode is integrated into the mechanical and electrical control device 320, and the multi-channel stimulation electrode and position sensor 324 receive the control signal transmitted from the mechanical support and the electrical signal transmission channel.

[0075] The position sensor feeds back the electrode position information to the position sensor signal processing module 330, which determines the position deviation of the electrode based on the actual position information and issues adjustment instructions to the mechanical electric control device 320 to correct the position of the electrode in real time to ensure that the electrode is always at the predetermined target point. Through the real-time feedback adjustment mechanism of the sensor and signal processing module, the system can immediately correct the electrode position when it deviates, thereby improving the accuracy of electrode positioning, avoiding the possibility of mis-stimulation or ineffective stimulation, and further ensuring the safety and effectiveness of treatment.

[0076] This closed-loop multi-channel multi-mode time-domain interferometric electrical stimulation system can use the target area dynamic adjustment algorithm module and the hardware system level support as mentioned above to achieve dynamic adjustment of the stimulated brain target area. Based on actual tests and simulation calculations, it is found that when the position and excitation size of the stimulation electrode are adjusted, the position and amplitude of the electric field envelope formed between the two electrodes will change. At the same time, changing the TI mode (parallel conduction, cross conduction) will also affect the electric field envelope. Figure 5-10 This is an example of the simulation results of the distribution of the TI envelope after the target area dynamic adjustment module optimizes the electrode excitation and position according to the corresponding algorithm.

[0077] Figure 5 This is the distribution diagram of the TI envelope when the currents of the two electrodes are 5mA, 2000Hz and 5mA, 2010Hz respectively in the parallel conduction mode. The electric field envelope generated under this configuration is relatively uniform, and the electric field distribution is mainly concentrated between the two electrodes. The electric field amplitude is moderate, which is conducive to producing a stable stimulation effect.

[0078] Figure 6This is the distribution diagram of the TI envelope when the currents of the two electrodes are 5mA, 2000Hz and 1mA, 2010Hz respectively in the parallel conduction mode. This configuration breaks the symmetry of the electric field envelope, and the electric field is concentrated on the side of the electrode with larger current, resulting in uneven distribution of the envelope electric field. It is suitable for biased stimulation of specific target areas.

[0079] Figure 7 This is the distribution diagram of the TI envelope when the currents of the two electrodes are 5mA, 2000Hz and 5mA, 2010Hz respectively in the parallel conduction mode, and the distances are different. The concentration of the envelope electric field is improved, and the electric field is concentrated between the electrodes, which can generate a strong local electric field, which is suitable for concentrated stimulation in a small range.

[0080] Figure 8 In the parallel conduction mode, the currents of the two conduction electrodes are 5mA, 2000Hz and 5mA, 2010Hz respectively, and the distribution diagram of the TI envelope when the distance difference increases. Increasing the electrode spacing will cause the distribution range of the electric field envelope to expand, but the electric field strength will be relatively weakened, so that the stimulation range increases but the intensity becomes weaker, which is suitable for a large range of low-intensity stimulation.

[0081] Fig. 9 In the parallel conduction mode, the currents of the two electrodes are 1mA, 2000Hz and 5mA, 2010Hz respectively, and the distance is different and increased, and the distribution diagram of the TI envelope when the two leads are inconsistent is superimposed, which causes the electric field envelope to be concentrated on the side of the electrode with larger current and the range is increased, which is suitable for providing asymmetric stimulation in a large range. The electric field intensity near the electrode with larger current is greater, thus producing a stronger bias effect on specific areas.

[0082] Fig.10 This is the distribution diagram of the TI envelope when the currents of the two electrodes are 5mA, 2000Hz and 5mA, 2010Hz respectively in the cross-conduction mode. The central area forms a larger value of the envelope electric field amplitude, but the maximum value appears at both ends of the axis. The cross-conduction mode will form a stronger electric field envelope in the central area where the electrodes cross. This mode is suitable for situations where a high-intensity electric field needs to be formed at the central target, but the maximum value of the electric field appears at both ends instead of the center, forming a distribution of peaks at both ends. It is suitable for auxiliary stimulation of both ends at the same time when the stimulation in the middle is strong.

[0083] These different combination examples show how the system of the present invention can accurately control the distribution and intensity of the electric field by adjusting the electrode spacing, current intensity, frequency, and guidance mode with the support of the dynamic adjustment target area algorithm. This flexibility enables the system to adapt to different clinical or experimental needs, thereby achieving more accurate stimulation target control and improving the effectiveness and safety of treatment.

[0084] In one embodiment, a closed-loop multi-channel multi-mode time-domain interference electrical stimulation method is based on the closed-loop multi-channel multi-mode time-domain interference electrical stimulation system in the above embodiment, such as Figure 4 As shown, the method comprises the following steps:

[0085] S10, obtaining stimulation parameters, and issuing stimulation instructions according to the stimulation parameters, such as stimulation current, frequency, stimulation mode, etc.

[0086] S20, analyzing the stimulation instruction issued in S10, and outputting the analyzed control signal to drive the subsequent electrical stimulation execution.

[0087] S30, stimulating the human scalp according to the control signal output by S20;

[0088] S40, monitoring the accuracy and impedance information of the output current when S30 stimulates the human scalp, adjusting the control signal output by S20 according to the accuracy and impedance information, and then repeating S30 to S40.

[0089] Among them, the control signal output by S20 is adjusted according to the accuracy and impedance information. Specifically, after receiving the accuracy and impedance information, the core main control and functional circuit modules will compare these data with the set standard threshold, and based on the difference or deviation, execute the corresponding adjustment algorithm (such as proportional integral differential control algorithm or adaptive control algorithm) to dynamically adjust the amplitude or frequency of the control signal so that the output current can meet the set accuracy and stability requirements again. If the accuracy and impedance still do not meet the requirements after adjustment, the system will further optimize the control signal and repeat the adjustment process until the accuracy and impedance information meet the set standards.

[0090] In this closed-loop control embodiment, S20 to S40 form a loop, and S40 adjusts the control signal through feedback to ensure the accuracy of the current output, thereby improving the stability of the stimulation effect and the accuracy of control, and effectively reducing the signal deviation caused by impedance changes during the stimulation process.

[0091] In one embodiment, step S30 further includes:

[0092] S50, collecting the EEG signal during stimulation in S30, adjusting the stimulation parameters obtained in S10 according to the EEG signal, and repeating S20 to S40. In this closed-loop control embodiment, S10, S20, S30 to S50 form a cycle, and the EEG signal collected in S50 dynamically optimizes the stimulation parameters, so that the stimulation can not only be adjusted according to the accuracy and impedance information, but also can achieve personalized optimization based on the biological signal feedback, further improving the effectiveness and adaptability of electrical stimulation.

[0093] In one embodiment, after step S50, the method further includes:

[0094] S60, evaluate the effectiveness and effect of the stimulation based on the EEG signals collected by S50, and stop the stimulation if the effectiveness and effect of the stimulation meet expectations. In this embodiment, S60 evaluates the effectiveness and effect of the stimulation based on the EEG signals, so that the system can not only optimize the parameters, but also automatically terminate the stimulation when the expected effect is achieved, thereby avoiding the risk of over-stimulation. By adding effect evaluation to the closed-loop control, the system can automatically terminate the stimulation after ensuring that the ideal effect is achieved, which not only improves the intelligence of the system, but also effectively protects the patient from unnecessary stimulation, ensuring the safety of the treatment process and the accuracy of the effect.

[0095] In the description of this specification, if the terms "embodiment one", "this embodiment", "in an embodiment" and the like appear, it means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in the invention or at least one embodiment or example of the invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example; moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in an appropriate manner.

[0096] In the description of this specification, the terms "connect", "install", "fix", "set", "have", etc. are all understood in a broad sense. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0097] In the description of this specification, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "comprises", "comprising" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the statement "comprising a ..." does not exclude the presence of other identical elements in the process, method, article or device including the element.

[0098] The above description of the embodiments is to facilitate ordinary technicians in the technical field to understand and apply the technology of this case. People familiar with the technology in this field can obviously easily make various modifications to these examples and apply the general principles described here to other embodiments without creative work. Therefore, this case is not limited to the above embodiments. Modifications to the following situations should all be within the scope of protection of this case: ① A new technical solution implemented based on the technical solution of the present invention and combined with existing common knowledge, the technical effect produced by the new technical solution does not exceed the technical effect of the present invention; ② The equivalent replacement of some features of the technical solution of the present invention by using known technology, the technical effect produced is the same as the technical effect of the present invention; ③ The technical solution of the present invention can be expanded, and the substantive content of the expanded technical solution does not exceed the technical solution of the present invention; ④ The equivalent transformation made by using the contents of the description and drawings of the present invention is directly or indirectly applied to other related technical fields.

Claims

1. A closed-loop multi-channel multi-mode time-domain interferometric electrical stimulation system, characterized in that: include: The software part includes a time domain interference electrical stimulation function module and an electroencephalogram analysis algorithm module. The software part obtains the target position. The time domain interference electrical stimulation function module determines the stimulation parameters according to the target position. The software part issues stimulation instructions according to the stimulation parameters. The stimulation parameters include stimulation current, stimulation frequency, stimulation time, TI mode and electrode position. The TI mode is cross conduction. A core main control and functional circuit module, whose signal is connected to the software part, the core main control and functional circuit module receives the stimulation instruction issued by the software part and parses it, and the core main control and functional circuit module outputs the parsed control signal; An electrode position automatic adjustment device, whose signal is connected to the core main control and functional circuit module, and the electrode position automatic adjustment device receives the control signal output by the core main control and functional circuit module; A multi-conducting electrode device, whose signal is connected to the electrode position automatic adjustment device, the electrode position automatic adjustment device adjusts the spatial position of the multi-conducting electrode device according to the control signal, and the multi-conducting electrode device stimulates the target position on the human scalp under the stimulation parameters according to the control signal; the electrode position automatic adjustment device includes a main control and core circuit module, a mechanical electric control device and a position sensor signal processing module, the main control and core circuit module receives the control signal output by the core main control and functional circuit module, and analyzes the control signal to obtain the next level control signal; the mechanical electric control device includes a main control device, a mechanical support channel, an electrical signal transmission channel and a position sensor, The main control device receives the next level control signal; the mechanical support channel signal is connected to the main control device, and the mechanical support channel is mobilized according to the next level control signal to adjust the spatial position of the multi-conductive electrode device; the next level control signal of the main control device is transmitted to the multi-conductive electrode device through the electrical signal transmission channel, and the multi-conductive electrode device stimulates the target position on the human scalp under the stimulation parameters according to the next level control signal; the position sensor monitors the position information of the multi-conductive electrode device in real time; the position sensor signal processing module receives the position information, and optimizes the adjustment of the spatial position of the multi-conductive electrode device by the mechanical electrical control device according to the position information; A current output precision and impedance monitoring module, which is respectively connected to the multi-conducting electrode device and the core main control and functional circuit module by signals, the current output precision and impedance monitoring module includes a current monitoring unit and an impedance measurement unit, and respectively monitors the precision and impedance information of the electrode output current of the multi-conducting electrode device, and transmits the precision and impedance information to the core main control and functional circuit module, and the core main control and functional circuit module adjusts the control signal according to the precision and impedance information; The electroencephalogram device collects electroencephalogram signals synchronously and in real time when the multi-electrode device performs stimulation; the electroencephalogram analysis algorithm module receives the electroencephalogram signals, and evaluates the effectiveness and effect of the stimulation according to the electroencephalogram signals, and obtains the evaluation results; The software part also includes a target area dynamic adjustment algorithm module. The time domain interference electrical stimulation function module, the EEG analysis algorithm module and the target area dynamic adjustment algorithm module are signal-connected in pairs. The time domain interference electrical stimulation function module and the target area dynamic adjustment algorithm module optimize the stimulation parameters in real time according to the evaluation results.

2. The electrical stimulation system according to claim 1, characterized in that: The stimulation parameters include stimulation current, stimulation frequency, stimulation time, TI mode and electrode position; The time domain interference electrical stimulation function module optimizes the stimulation current, stimulation frequency, and stimulation time, and the target area dynamic adjustment algorithm module optimizes the TI mode and electrode position.

Images