Closed-loop percutaneous ear vagus nerve stimulation system acting on insomnia

Abstract

A closed-loop percutaneous ear vagus nerve stimulation system acting on insomnia, the system comprising: an electrocardiogram monitor for monitoring the heart rate of a patient; the power supply module is used for supplying power to the electrocardiogram monitor; the heart rate variability sensor is used for sensing heart rate data, collecting the heart rate data and transmitting the heart rate data to the feedback controller; the feedback microcontroller is used for receiving and processing the heart rate data and identifying abnormal heart rate data generated before or during the attack of insomnia; the pulse generator is used for outputting electric pulses to the percutaneous auricular concha area vagus nerve stimulator; and the percutaneous auricular concha area vagus nerve stimulator is used for stimulating the auricular concha area vagus nerve by adopting a vagus nerve stimulating electrode.

Description

Technical Field:

[0001] The present invention relates to a closed-loop transcutaneous auricular vagus nerve stimulation system for treating insomnia. Background Art:

[0002] Transcutaneous vagus nerve stimulation is a new, safe, and non-invasive method of vagus nerve stimulation that can act on the superficial auricular branch of the vagus nerve distributed in the skin of the outer ear auricle, without the risk of electrode surgical implantation. The concha area is the area where the auricular vagus nerve is distributed and is the only area on the body surface where the vagus nerve is distributed. Stimulating the concha can activate the auricular branch of the vagus nerve, which is transmitted from the periphery to the central nervous system and projects directly or indirectly to multiple nuclei such as the locus coeruleus, hypothalamus, and hippocampus through the solitary tract nucleus. Its efferent fibers can also innervate peripheral organs such as the cardiovascular system and gastrointestinal system. By stimulating this pathway, the activity of related areas of the cerebral cortex can be regulated. Therefore, transcutaneous auricular vagus nerve stimulation can play an important role in the treatment of brain, human inflammation, mental, and psychological related diseases. However, most of the existing transcutaneous vagus nerve stimulation systems are in the form of open-loop control, and the stimulation time cannot be accurately adjusted and controlled. At the same time, the stimulation efficacy in clinical practice cannot meet the actual needs, resulting in discomfort in the patient's nerves and a relatively large treatment risk. Summary of the Invention:

[0003] An embodiment of the present invention provides a closed-loop transcutaneous auricular vagus nerve stimulation system for treating insomnia, with a reasonable structural design. It adopts a closed-loop control treatment form, adjusts the corresponding treatment state according to the patient's physiological changes, and selectively triggers stimulation through the patient's own physiological activities only when a pathological state is detected. Compared with the open-loop control treatment form, closed-loop nerve regulation can control the stimulation time, enhance the stimulation efficacy in clinical practice, and reduce the risk of nerve discomfort in patients. Adopting a "monitoring - feedback - treatment" closed-loop nerve regulation mode can broaden the clinical application of vagus nerve stimulation, provide theoretical support for the development of new nerve regulation technologies and methods, and make non-invasive vagus nerve stimulation, that is, transcutaneous vagus nerve stimulation, have a broader application prospect than traditional invasive treatment methods, solving the problems existing in the prior art.

[0004] The technical solution adopted by the present invention to solve the above technical problems is:

[0005] A closed-loop transcutaneous auricular vagus nerve stimulation system for treating insomnia, the system comprising:

[0006] An electrocardiogram monitor for monitoring the patient's heart rate;

[0007] A power supply module for supplying power to the electrocardiogram monitor;

[0008] A heart rate variability sensor, which is used to sense heart rate data, collect heart rate data and transmit it to a feedback controller;

[0009] A feedback microcontroller, which is used to receive and process heart rate data and identify abnormal heart rate data generated before or during an insomnia attack;

[0010] A pulse generator, which is used to output electrical pulses to a transcutaneous auricular vagus nerve stimulator;

[0011] A transcutaneous auricular vagus nerve stimulator, which is used to stimulate the auricular vagus nerve with a vagus nerve stimulation electrode.

[0012] The power supply module, the heart rate variability sensor, the feedback microcontroller and the pulse generator together form a self-feedback module.

[0013] The electrocardiogram monitor includes a main lead, a positive and negative double lead and positive and negative electrode patches. The negative electrode patch is attached to the intersection of the right midclavicular line and the second rib, and the positive electrode patch is attached to the intersection of the left anterior axillary line and the fifth rib to continuously monitor and transmit the human electrocardiogram signal, converge the signal to the main lead through the positive and negative double leads, and transmit it to the heart rate variability sensor.

[0014] The heart rate variability sensor includes a signal receiving module, a preprocessing module, a calculation module and an output module; the signal receiving module is used to receive the electrocardiogram signal transmitted by the electrocardiogram monitor;

[0015] The preprocessing module includes an outlier identification unit, a filter unit and a QRS identification unit, which are used to preprocess the electrocardiogram signal; the calculation module is used to analyze the electrocardiogram signal to obtain an NN interval sequence; the output module is used to obtain the relevant analysis results of HRV parameters according to the NN interval sequence, output HRV parameters, and transmit them to the feedback microcontroller through an electrical signal.

[0016] The feedback controller includes a signal receiving unit, a microprocessor and a switch; the feedback microcontroller can set the abnormal HRV parameter threshold and abnormal HRV parameter range before or during an insomnia attack. After receiving the HRV parameter sensing electrical signal, the feedback microcontroller identifies the abnormal HRV parameters before or during an insomnia attack, compares the received HRV parameter signal with the preset abnormal HRV parameter characteristic values before or during an insomnia attack. When it is higher than the highest threshold of abnormal HRV parameters or lower than the lowest threshold of abnormal HRV parameters, the control switch on the feedback microcontroller is turned on to trigger the pulse generator.

[0017] The abnormal HRV parameter threshold P mn =(P0 - P s ) * (1 ± 20%) + Ps , the change rate R of HRV parameters hr = [(P m - P s ) - (P0 - P s )] / P0, where P mn is the maximum or minimum abnormal HRV parameter threshold, P s is the average value of the HRV parameters output by the heart rate variability sensor during the background heart rate variability per unit time, P0 is the average value of the HRV parameters output by the sensor during the normal heart rate variability per unit time, where P m is the average value of the HRV parameters output by the sensor during the maximum or minimum heart rate variability per unit time, and the feedback microcontroller can calculate the value of P m in real time according to the HRV parameters output by the heart rate variability sensor.

[0018] The output pulse frequency of the pulse generator is 1 - 145 Hz, and the voltage is 0 - 12 V.

[0019] The transcutaneous auricular vagus nerve stimulator receives the electrical pulses emitted by the pulse generator, so that the vagus nerve stimulation electrode outputs a short - term pulsed electrical stimulation acting on the auricular vagus nerve in the ear concha area to achieve the nerve regulation effect.

[0020] With the above structure, the present invention adopts a new "monitoring - feedback - treatment" closed - loop nerve regulation mode, which can broaden the clinical application of vagus nerve stimulation and provide theoretical support for the development of new nerve regulation technologies and methods; the heart rate variability sensor senses and collects heart rate data and transmits it to the feedback controller; the feedback microcontroller receives and processes the heart rate data to identify abnormal heart rate data generated before or during the onset of insomnia; the pulse generator is used to output electrical pulses to the transcutaneous auricular vagus nerve stimulator, having the advantages of precision, high efficiency, safety and practicality. BRIEF DESCRIPTION OF THE DRAWINGS:

[0021] Figure 1 is a schematic structural diagram of the present invention.

[0022] Figure 2 is a working principle diagram of the heart rate variability sensor, feedback microcontroller and pulse generator of the present invention.

[0023] Figure 3 is a schematic structural diagram of the heart rate variability sensor of the present invention.

[0024] Figure 4 is a schematic diagram of the overall circuit structure of the feedback microcontroller of the present invention.

[0025] In the figure, ① electrocardiogram monitor, ② self-feedback module, ③ auricular vagus nerve stimulator, ④ heart rate variability sensor, ⑤ feedback microcontroller, A: concha cavum auriculae, B: concha cymbae auriculae, 1: power supply interface, 2: ear-hanging structure, 3: auricular cymbae vagus nerve stimulation electrode, 4: concha cavum auriculae knob, 5: auricular cymbae knob, 6: concha cavum auriculae vagus nerve stimulation electrode, 7: main lead wire, 8: positive and negative double lead wire, 9: negative electrode patch, 10: positive electrode patch, 401: signal receiving module, 402: preprocessing module, 403: calculation module, 404: output module, 4021: outlier recognition unit, 4022: filter unit, 4023: QRS recognition unit, 501: signal receiving unit, 502: microprocessor, 503: switch. Detailed implementation manners:

[0026] To clearly illustrate the technical features of this solution, the present invention will be elaborated in detail below through specific implementation manners and in conjunction with its attached drawings.

[0027] As Figures 1-4 shown in

[0028] An electrocardiogram monitor, which is used to monitor the heart rate of a patient;

[0029] A power supply module, which is used to supply power to the electrocardiogram monitor;

[0030] A heart rate variability sensor, which is used to sense heart rate data, collect heart rate data and transmit it to the feedback controller;

[0031] A feedback microcontroller, which is used to receive and process heart rate data and identify abnormal heart rate data generated before or during an insomnia attack;

[0032] A pulse generator, which is used to output electrical pulses to the transcutaneous auricular vagus nerve stimulator;

[0033] A transcutaneous auricular vagus nerve stimulator, which is used to stimulate the auricular vagus nerve in the auricular area by using a vagus nerve stimulation electrode.

[0034] The power supply module, heart rate variability sensor, feedback microcontroller and pulse generator together form a self-feedback module.

[0035] The electrocardiogram monitor includes a main lead wire, a positive and negative double lead wire and positive and negative electrode patches. The negative electrode patch is attached to the intersection of the right midclavicular line and the second rib, and the positive electrode patch is attached to the intersection of the left anterior axillary line and the fifth rib to monitor and transmit the human electrocardiogram signal in real time. The signal is converged to the main lead wire through the positive and negative double lead wire and transmitted to the heart rate variability sensor.

[0036] The heart rate variability sensor includes a signal receiving module, a preprocessing module, a calculation module, and an output module; the signal receiving module is used to receive the electrocardiogram signal transmitted by the electrocardiogram monitor;

[0037] The preprocessing module includes an outlier identification unit, a filter unit, and a QRS identification unit, and is used to preprocess the electrocardiogram signal; the calculation module is used to analyze the electrocardiogram signal to obtain an NN interval sequence; the output module is used to obtain the relevant analysis results of HRV parameters according to the NN interval sequence, output HRV parameters, and transmit them to the feedback microcontroller through an electrical signal.

[0038] The feedback controller includes a signal receiving unit, a microprocessor, and a switch; the feedback microcontroller can set the abnormal HRV parameter threshold and the abnormal HRV parameter range before or during the onset of insomnia. After receiving the HRV parameter sensing electrical signal, the feedback microcontroller identifies the abnormal HRV parameters before or during the onset of insomnia, compares the received HRV parameter signal with the preset abnormal HRV parameter characteristic values before or during the onset of insomnia. When it is higher than the highest threshold of the abnormal HRV parameter or lower than the lowest threshold of the abnormal HRV parameter, the control switch on the feedback microcontroller is turned on to trigger the pulse generator.

[0039] The abnormal HRV parameter threshold P mn =(P0 - P s )*(1 ± 20%) + P s , the HRV parameter change rate R hr =[(P m - P s ) - (P0 - P s )] / P0, where P mn is the maximum or minimum abnormal HRV parameter threshold, P s is the average value of the HRV parameters output by the heart rate variability sensor during background heart rate variability per unit time, P0 is the average value of the HRV parameters output by the sensor during normal heart rate variability per unit time, where P m is the average value of the HRV parameters output by the sensor during the maximum or minimum heart rate variability per unit time. The feedback microcontroller can calculate the value of P m in real time according to the HRV parameters output by the heart rate variability sensor.

[0040] The output pulse frequency of the pulse generator is 1 - 145 Hz, and the voltage is 0 - 12 V.

[0041] The transcutaneous auricular vagus nerve stimulator receives the electrical pulse emitted by the pulse generator, so that the vagus nerve stimulation electrode outputs a short-term pulsed electrical stimulation acting on the auricular vagus nerve in the ear concha area to achieve the effect of nerve regulation.

[0042] The working principle of a closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia in the embodiments of the present invention is as follows: adopting a closed-loop control treatment form, adjusting the corresponding treatment state according to the physiological changes of the patient. When a pathological state is detected, the stimulation is selectively triggered through the patient's own physiological activities. Compared with the open-loop control treatment form, the closed-loop nerve regulation can control the stimulation time, enhance the clinical stimulation efficacy and reduce the risk of nerve discomfort of the patient; adopting a "monitoring - feedback - treatment" closed-loop nerve regulation mode can broaden the clinical application of vagus nerve stimulation and provide theoretical support for the development of new nerve regulation technologies and methods, making non-invasive vagus nerve stimulation, that is, transcutaneous vagus nerve stimulation, have a broader application prospect than traditional invasive treatment methods.

[0043] The closed-loop nerve stimulation system can adjust the treatment state according to physiological changes, that is, only when a pathological state is detected, the stimulation is selectively triggered through the patient's own physiological activities; compared with open-loop therapy, the closed-loop nerve regulation can control the stimulation time, enhance the clinical stimulation efficacy and reduce the risk of nerve discomfort; recent studies have shown that there is an association between insomnia and abnormal autonomic nervous system activity. Heart rate variability refers to the minute differences in the cardiac cycle between successive sinus rhythm heart beats, which quantitatively reflects the condition of the autonomic nervous system. HRV biofeedback uses HRV as a training index and has achieved certain curative effects in improving mood disorders such as insomnia, anxiety, and depression. After the sleep treatment is improved, the heart rate variability of the patient also returns to normal. Therefore, it is feasible to construct a closed-loop vagus nerve stimulation system that can identify abnormal heart rate events and trigger electrical stimulation.

[0044] In the overall scheme, the nerve stimulation system includes an electrocardiogram monitor for monitoring the heart rate of the patient; a power supply module for supplying power to the electrocardiogram monitor; a heart rate variability sensor for sensing, collecting and transmitting heart rate data to the feedback controller; a feedback microcontroller for receiving and processing heart rate data and identifying abnormal heart rate data generated before or during the onset of insomnia; a pulse generator for outputting electrical pulses to the transcutaneous auricular vagus nerve stimulator; and a transcutaneous auricular vagus nerve stimulator for stimulating the auricular vagus nerve in the auricular concha area using vagus nerve stimulation electrodes.

[0045] Further, the power module, heart rate variability sensor, feedback microcontroller, and pulse generator together form a self-feedback module. The power module is charged through the power interface, and the power module supplies power to the self-feedback module. The negative electrode patch 9 in the electrocardiogram monitor is attached to the intersection of the right midclavicular line and the second rib, and the positive electrode patch 10 is attached to the intersection of the left anterior axillary line and the fifth rib to continuously monitor and transmit the human electrocardiogram signal. The electrocardiogram signal is converged to the main wire 7 through the positive and negative double wires 8 and transmitted to the heart rate variability sensor. The heart rate variability sensor detects the electrocardiogram signal transmitted by the electrocardiogram monitor, collects heart rate data, and transmits it to the feedback microcontroller; the feedback microcontroller receives and processes the heart rate data, identifies the abnormal heart rate data generated before or during the onset of insomnia, and triggers the pulse generator to output an electrical pulse to the transcutaneous auricular vagus nerve stimulation device, and the vagus nerve stimulation electrode stimulates the auricular vagus nerve in the auricular concha area.

[0046] The electrical stimulation acts on the vagus nerve distributed in the auricular concha and cymba conchae areas in the form of an electric current, activates the auricular branch of the vagus nerve, is transmitted from the periphery to the center, and projects directly or indirectly to multiple central sleep structures such as the locus coeruleus, hypothalamus, and hippocampus through the solitary tract nucleus, and then participates in the regulation of sleep, ultimately achieving the purpose of promoting and regulating vagus nerve treatment for insomnia.

[0047] In the self-feedback module, the heart rate variability sensor collects HRV parameters and transmits them to the feedback microcontroller. The feedback microcontroller receives and processes the heart rate data. When it is recognized that the heart rate signal is higher than the highest threshold of the abnormal HRV parameters or lower than the lowest threshold of the abnormal HRV parameters, the control switch is turned on, thereby triggering the pulse generator to start working; when the heart rate signal is between the lowest threshold and the highest threshold of the abnormal HRV parameters, the control switch is turned off, the pulse generator does not work, and the feedback microcontroller continues to perform the heart rate detection and recognition functions; the electrocardiogram monitoring main wire is connected to the S in port of the heart rate sensor and is sequentially connected to the input S in port of the feedback microcontroller. The capacitor in the power module is connected to the V in port of the heart rate variability sensor and the feedback microcontroller. There is a control switch between the V in port of the feedback microcontroller and the V out port of the feedback microcontroller, and V out is connected to the pulse generator.

[0048] For a transcutaneous auricular vagus nerve stimulator, it includes a power interface 1, an ear-hanging structure 2, a cymba conchae vagus nerve stimulation electrode 3, an ear concha knob 4, a cymba conchae knob 5, and an ear concha vagus nerve stimulation electrode 6; the power interface 1 can charge the device, and the device can be hung on the back of the patient's ear through the ear-hanging structure 2. One end of the ear-hanging structure 2 is rotatably connected to the ear concha knob 4 to adjust the position of the ear concha vagus nerve stimulation electrode 6; similarly, one end of the cymba conchae vagus nerve stimulation electrode 3 is rotatably connected to the cymba conchae knob 5 to adjust the position of the cymba conchae vagus nerve stimulation electrode 3; the cymba conchae vagus nerve electrode 2 closely adheres to the cymba conchae B area of the ear, and the position of the cymba conchae electrode can be adjusted by rotating the cymba conchae knob 5 according to the structure of one's own ear; correspondingly, the ear concha vagus nerve electrode 6 closely adheres to the ear concha A area of the ear, and the position of the ear concha electrode can be adjusted by rotating the ear concha knob 4 according to the structure of one's own ear; the cymba conchae vagus nerve electrode 2 and the ear concha vagus nerve stimulation electrode 6 can electrically stimulate the auricular vagus nerve to regulate nerve and treat insomnia.

[0049] For a heart rate variability sensor, it includes a signal receiving module 401, a preprocessing module 402, a calculation module 403, and an output module 404. The signal receiving module 401 is used to receive an electrocardiogram signal, perform analog-to-digital conversion on the original electrocardiogram signal to obtain an electrocardiogram digital signal; the preprocessing module 402 is used to preprocess the electrocardiogram digital signal to obtain electrocardiogram data, which includes an outlier identification unit 4021, a filter unit 4022, and a QRS identification unit 4023. The outlier identification unit 4021 determines abnormal data in the electrocardiogram digital signal.

[0050] Specifically, the process of outlier identification is as follows: First, calculate the mean and variance of all electrocardiogram samples respectively, and then take the values outside the interval [u - 3σ, u + 3σ] as outliers, where u represents the mean of the electrocardiogram samples and σ represents the standard deviation of the electrocardiogram samples; further, the filter unit 4022 uses a FIR high-pass filter to filter out baseline drift, uses a Notch filter to filter out power frequency interference, uses an IIR low-pass filter to filter out high-frequency electromyogram interference, removes abnormal data, and completes artifact identification and filtering. The QRS identification unit 4023 identifies the QRS complex reference points in the electrocardiogram signal. The calculation module 403 obtains the RR interval sequence and edits it. Through a preset algorithm of linear interpolation or cubic spline interpolation, the RR interval is interpolated to obtain the sinusoidal beat RR interval for heart rate variability analysis, denoted as the NN interval sequence; the output module 404 calculates HRV time domain parameters according to the NN interval sequence, including SDNN, SDANN, RMSSD, pNN50, and SDSD, and frequency domain parameters including HF, LF, and LF / HF.

[0051] For the feedback microprocessor, it includes a signal receiving unit 501, a microprocessor 502, and a switch 503. The HRV parameters collected by the heart rate variability sensor are received by the data receiving unit 501 through port S in and passed to the microprocessor. The microprocessor 502 compares the received HRV parameters with the abnormal HRV parameter thresholds. When it is recognized that the HRV parameter is higher than the highest abnormal HRV parameter threshold or lower than the lowest abnormal HRV parameter threshold, that is, when the change rate Rhr of the HRV parameter is greater than 20% or less than 20%, the microprocessor controls V in port and V out the control switch 503 between the ports is opened, the power supply module and the pulse generator form a path, the energy stored in the capacitor in the power supply module is transferred to the pulse generator, and the pulse generator starts to work; when the HRV parameter is between the lowest abnormal HRV parameter threshold and the highest threshold, that is, when the change rate Rhr of the HRV parameter is between -20% and 20%, the microprocessor 502 controls V in port and V out the control switch 503 between the ports is closed, the power supply module and the pulse generator are in an open circuit, the pulse generator does not work, and the feedback microcontroller continues to perform the HRV parameter detection and recognition functions.

[0052] In actual use, before the auricular vagus nerve stimulation, the electrocardiogram signal of the patient is monitored in real time through an electrocardiograph monitor and transmitted to the heart rate variability sensor to determine the HRV parameters, clarify the maximum and minimum thresholds of the HRV parameters, and set the abnormal HRV parameters and the HRV parameter thresholds for starting the control switch on the microprocessor through computer programming.

[0053] Specifically, the abnormal HRV parameter threshold P mn for starting the control switch = (P0 - P s ) * (1 ± 20%) + P s , where P mn is the maximum or minimum abnormal HRV parameter threshold, P s is the average value of the HRV parameters output by the heart rate variability sensor during the background heart rate variability per unit time, and P0 is the average value of the HRV parameters output by the sensor during the normal heart rate variability per unit time.

[0054] Set the abnormal HRV parameter threshold for starting the control switch on the microprocessor, compare the abnormal HRV parameter threshold with the patient's current HRV parameters, calculate the change rate Rhr of the HRV parameters. When Rhr is greater than 20% or less than 20%, start the control switch to trigger the pulse generator to output a stimulation signal, which is transmitted to the auricular vagus nerve stimulation electrode and an electrical stimulation action is released at the auricular vagus nerve.

[0055] Specifically, the change rate R of the HRV parameterhr = [(P m - P s ) - (P0 - P s )] / P0, where P m is the average value of the HRV parameters output by the sensor during the maximum or minimum heart rate variation per unit time, P s is the average value of the HRV parameters output by the heart rate variability sensor during the background heart rate variation per unit time, and P0 is the average value of the HRV parameters output by the sensor during the normal heart rate variation per unit time. The feedback microcontroller can calculate the value of P m in real time according to the HRV parameters output by the heart rate variability sensor.

[0056] Specifically, the output pulse frequency of the pulse generator is set to 1145 Hz, and the voltage is 012.0 V. When the pulse generator starts to work, it can emit electrical pulses that are transmitted through the internal circuit of the ear-hanging area to the vagus nerve stimulation electrodes in the cymba conchae and cavum conchae areas, acting on the vagus nerve distributed in the cavum conchae and cymba conchae areas, activating the auricular branch of the vagus nerve, and then regulating sleep.

[0057] In summary, a closed-loop transcutaneous auricular vagus nerve stimulation system for treating insomnia in the embodiments of the present invention adopts a closed-loop control treatment form, adjusts the corresponding treatment state according to the physiological changes of the patient, and selectively triggers stimulation through the patient's own physiological activities only when a pathological state is detected. Compared with the open-loop control treatment form, the closed-loop nerve regulation can control the stimulation time, enhance the clinical stimulation efficacy, and reduce the risk of nerve discomfort for patients; adopting a "monitoring - feedback - treatment" closed-loop nerve regulation mode can broaden the clinical application of the vagus nerve stimulation technique, provide a theoretical support for the development of new nerve regulation techniques and methods, and make non-invasive vagus nerve stimulation, that is, transcutaneous vagus nerve stimulation, have a broader application prospect than traditional invasive treatment methods.

[0058] The above specific implementation manners cannot be used as a limitation to the protection scope of the present invention. For those skilled in the art of this technology, any alternative improvement or transformation made to the embodiments of the present invention falls within the protection scope of the present invention.

[0059] Where the present invention is not elaborated, it is all well-known techniques to those skilled in the art of this technology.

Claims

1. A closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia, characterized in that, The system includes: An electrocardiogram monitor, which is used to monitor the heart rate of a patient; A power supply module, which is used to supply power to the electrocardiogram monitor; A heart rate variability sensor, which is used to sense, collect heart rate data and transmit it to a feedback controller; A feedback microcontroller, which is used to receive and process heart rate data and identify abnormal heart rate data generated before or during an insomnia attack; A pulse generator, which is used to output electrical pulses to a transcutaneous auricular vagus nerve stimulator; A transcutaneous auricular vagus nerve stimulator, which is used to stimulate the auricular vagus nerve in the auricular area by using a vagus nerve stimulation electrode; 2. The closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 1, wherein: The power supply module, the heart rate variability sensor, the feedback microcontroller and the pulse generator together form a self-feedback module; 3. The closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 1, characterized in that: The electrocardiogram monitor includes a main lead, a positive and negative double lead and positive and negative electrode patches. The negative electrode patch is attached to the intersection of the right midclavicular line and the second rib, and the positive electrode patch is attached to the intersection of the left anterior axillary line and the fifth rib to monitor and transmit the human electrocardiogram signal in real time, converge the signal to the main lead through the positive and negative double lead, and transmit it to the heart rate variability sensor; 4. The closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 1, wherein: The heart rate variability sensor includes a signal receiving module, a preprocessing module, a calculation module and an output module; the signal receiving module is used to receive the electrocardiogram signal transmitted by the electrocardiogram monitor; The preprocessing module includes an outlier identification unit, a filter unit and a QRS identification unit, which are used to preprocess the electrocardiogram signal; the calculation module is used to analyze the electrocardiogram signal to obtain an NN interval sequence; the output module is used to obtain the relevant analysis results of HRV parameters according to the NN interval sequence, output HRV parameters, and transmit them to the feedback microcontroller through an electrical signal; 5. The closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 4, characterized in that: The feedback controller includes a signal receiving unit, a microprocessor and a switch; the feedback microcontroller can set the abnormal HRV parameter threshold and abnormal HRV parameter range before or during an insomnia attack. After receiving the HRV parameter sensing electrical signal, the feedback microcontroller identifies the abnormal HRV parameter before or during an insomnia attack, compares the received HRV parameter signal with the preset abnormal HRV parameter characteristic value before or during an insomnia attack. When it is higher than the highest threshold of the abnormal HRV parameter or lower than the lowest threshold of the abnormal HRV parameter, the control switch on the feedback microcontroller is turned on to trigger the pulse generator; 6. The closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 5, wherein: The abnormal HRV parameter threshold P mn =(P0 - P s ) * (1 ± 20%) + P s , the HRV parameter change rate R hr =[(P m -P s ) - (P0 - P s )] / P0, where P mn is the maximum or minimum abnormal HRV parameter threshold, P s is the average value of the HRV parameters output by the heart rate variability sensor during background heart rate variability per unit time, P0 is the average value of the HRV parameters output by the sensor during normal heart rate variability per unit time, where P m is the average value of the HRV parameters output by the sensor during the maximum or minimum heart rate variability per unit time, and the feedback microcontroller can calculate the value of P m in real time according to the HRV parameters output by the heart rate variability sensor.

7. A closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 1, characterized in that: The output pulse frequency of the pulse generator is 1 - 145 Hz, and the voltage is 0 - 12 V; 8. A closed-loop transcutaneous auricular vagus nerve stimulation system for insomnia according to claim 1, characterized in that: The transcutaneous auricular vagus nerve stimulator receives the electrical pulses emitted by the pulse generator, so that the vagus nerve stimulation electrode outputs a short-term pulsed electrical stimulation to act on the auricular vagus nerve to achieve a nerve regulation effect.

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