Percutaneous nerve field vagus nerve stimulation diagnosis and treatment equipment and diagnosis and treatment method thereof

Abstract

The invention discloses percutaneous nerve field vagus nerve stimulation diagnosis and treatment equipment and a diagnosis and treatment method thereof, and particularly relates to the technical field of neuromedicine, intelligent medical equipment and multi-mode physical therapy. The equipment comprises a neural signal acquisition module, a nerve positioning module, a data processing and analysis module, a treatment execution module and a diagnosis result output module; the system is further provided with a battery power management module, a self-adaptive closed-loop cloud platform and a wearable fixing device, by collecting bioelectricity signals, light absorptivity and temperature data of an ear nerve area, ear target cranial nerve branches are positioned, a dynamic diagnosis map is constructed, and a diagnosis result and personalized treatment parameters are generated. Electric pulse, near-infrared light and local thermal therapy multi-mode collaborative stimulation is adopted for treatment, and parameters are monitored and adjusted in real time through a cloud platform. According to the invention, accurate diagnosis and personalized treatment can be realized, the medical efficiency and the treatment effect are improved, and an effective means is provided for nerve disease diagnosis and treatment and pain relief.

Description

Technical Field

[0001] The present invention relates to the technical fields of neuromedicine, intelligent medical equipment and multimodal physical therapy, and more specifically, to a transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device and a diagnostic and therapeutic method thereof. Background Art

[0002] Electrical stimulation for patients with acute and chronic pain, insomnia, depression, post-stroke rehabilitation and drug addiction will cause different symptoms at different stages of the disease and different drug treatments. In addition, due to individual differences in the human body, the frequency and duration of electrical stimulation need to be precisely controlled.

[0003] The frequency of neuromodulation currently used is 200Hz-10kHz, and it is a single frequency. We have discovered for the first time that ultra-low frequencies of 1-10Hz produce better effects. Acute and chronic pain, insomnia, depression, stroke rehabilitation and drug addiction can lead to various physical problems, as well as psychological and social problems. The current common control method is mainly based on analgesics, which have great side effects and dependence. Factors such as increased drug tolerance will cause the drug to lose its effectiveness.

[0004] At present, there is no significant method of regulation through equipment. Secondly, clinical studies have found that low-frequency and longer-term stimulation can form an effective two-way effect on the nervous system and the immune system. The use scenario requires very high requirements for battery management, especially voltage control and working time. Secondly, when performing low-frequency stimulation, it is difficult to control whether the desired ganglion can be accurately stimulated, which will lead to a worse stimulation effect. Therefore, more accurate technology and equipment are needed to diagnose the desired ganglion, and according to the diagnosis position, automatically adjust the angle or position of the stimulation needle to achieve precise stimulation to ensure a significant effect on pain relief.

[0005] Therefore, a transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device and a diagnostic and therapeutic method thereof are proposed. Summary of the invention

[0006] In order to overcome the above-mentioned defects of the prior art, the present invention provides a transcutaneous nerve field vagus nerve stimulation diagnosis and treatment device and a diagnosis and treatment method thereof to solve the problems raised in the above-mentioned background technology.

[0007] To achieve the above-mentioned purpose, the present invention provides the following technical solution: a transcutaneous nerve field vagus nerve stimulation diagnosis and treatment device, comprising: (a) a neural signal acquisition module, configured to collect bioelectric signals, light absorption rate and temperature data of the ear nerve area, and connected to the data processing and analysis module through corresponding sensors; (b) Nerve localization module, which integrates micro-biosensors and medical imaging feedback units to locate the target cranial nerve branches in the ear in real time and verify the contact accuracy between the stimulation needle array and the nerve, including: High-precision impedance detection unit, which measures the local impedance changes of ear tissues through the stimulation needle array to identify the location of neurovascular bundles; The miniature ultrasound probe is embedded in the root of the stimulation needle, which generates local ultrasound images of the ear nerves in real time and compares them with the preset anatomical atlas to correct the implantation angle of the stimulation needle. (c) Data processing and analysis module, which receives data from the neural signal acquisition module and detection data from the neural localization module, and constructs a dynamic diagnostic map based on the patient's withdrawal symptom score (COWS), heart rate variability and skin electrical response data; uses data analysis algorithms to analyze and process the collected data, evaluate the neural status and function, and generate diagnostic results; generates personalized treatment parameters based on the diagnostic results and preset treatment rules; (d) A treatment execution module, including an electric pulse generation submodule and a multimodal stimulation submodule, wherein: The electric pulse generation submodule is configured to generate 1-10 Hz strategic variable frequency electric pulses according to the treatment parameters generated by the data processing and analysis module, and output them to the stimulation needle array through four electric pulse transmission lines; Multimodal stimulation submodules, including electrical stimulation needles, micro-phototherapy units, and localized thermal therapy patches, are used to enhance the neuromodulation effect; (e) The diagnosis result output module outputs the diagnosis results obtained by the data processing and analysis module in a visual manner, including charts, images, etc., to provide diagnostic references for medical personnel.

[0008] Preferably, it also includes: A battery power management module, including a battery management chipset consisting of a button battery and a DC-DC converter, wherein the button battery is used to provide power, and the DC-DC converter is used to stabilize the voltage at 3.6V; The adaptive closed-loop cloud platform connects to diagnostic and treatment equipment via Bluetooth, receives the patient's bioelectric signals, light absorption rate and temperature data in real time, and monitors and records the treatment process. During the treatment process, the treatment parameters are dynamically adjusted based on real-time monitoring data combined with the AI ​​big model. The wearable fixation device, made of biocompatible materials, includes an auricular-fitting bracket and a flexible adhesive patch to ensure stable contact of the stimulating needle array during dynamic activities.

[0009] Preferably, the micro phototherapy unit emits near-infrared light with a wavelength of 630-850nm and a penetration depth of 2-5mm, covering the target nerve area; the thermal therapy patch controls the temperature at 38-42°C through a micro Peltier element to stimulate local blood circulation.

[0010] Preferably, the bioelectric signal sensor in the neural signal acquisition module adopts a high-sensitivity electrode, which can accurately collect weak neural electrical signals; the light absorption rate sensor adopts a light emitting and receiving device of a specific wavelength to detect the light absorption of the target area; the temperature sensor adopts a miniature thermistor to quickly and accurately measure the local temperature.

[0011] Preferably, the data processing and analysis module uses a machine learning algorithm to extract features and classify the collected data to improve the accuracy and reliability of diagnosis; and can adaptively adjust the analysis model and parameters according to the individual differences of different patients.

[0012] Preferably, the diagnosis result output module is connected to an external display device or a medical information management system to achieve remote transmission and sharing of diagnosis results, thereby facilitating consultation and case management by the medical team.

[0013] Preferably, the stimulation needle array comprises a titanium alloy disc, a disc cover, a stimulation needle and a micro-mechanical arm, a plurality of micro-mechanical arms are installed above the titanium alloy disc, each of the micro-mechanical arms is connected to a stimulation needle, the disc cover is installed on the titanium alloy disc, and the bioelectric signal sensor is installed at the needle tip of the stimulation needle to receive the bioelectric signal; Among them, the number of stimulation needles includes single needle, four needles, six needles and eight needles, and the needle head of the stimulation needle is trapezoidal, the diameter of the connection between the tail contacting the titanium alloy disc and the micro-robotic arm is 0.4 mm, the needle length is 2.00 mm, and the needle tip is 0.05 mm.

[0014] A transcutaneous nerve field vagus nerve stimulation diagnosis and treatment method based on the above-mentioned transcutaneous nerve field vagus nerve stimulation diagnosis and treatment device comprises: Step 1: Collect bioelectric signals, light absorption rate and temperature data of the ear nerve area through the neural signal acquisition module; Step 2: Use the impedance detection and ultrasound imaging of the nerve localization module to determine the location and status of the target cranial nerve branches in the ear; Step 3: The collected data is transmitted to the data processing and analysis module, a dynamic diagnostic map is constructed and data analysis is performed to evaluate the nerve status and function and generate diagnostic results; personalized treatment parameters are generated based on the diagnostic results; Step 4: Output the diagnosis result through the diagnosis result output module; Step 5: Start the treatment execution module and perform multimodal coordinated stimulation according to the generated treatment parameters, with synchronous action of electric pulses, near-infrared light and local hyperthermia; Step 6: Monitor the patient’s physiological data in real time through an adaptive closed-loop cloud platform, dynamically adjust treatment parameters, and generate efficacy reports in real time.

[0015] Technical effects and advantages of the present invention: Through the collaborative work of the neural signal acquisition module, the neural positioning module and the data processing and analysis module, multiple types of data in the ear nerve area are accurately collected, and a dynamic diagnostic map is constructed in combination with multiple physiological indicators. The nerve state and function are accurately evaluated, and stimulation treatment is directly performed on the corresponding ganglia, which effectively relieves pain symptoms and improves diagnostic accuracy and reliability. Different electric pulse stimulation intensities can be used for different patients to improve treatment compliance.

[0016] Personalized treatment parameters are generated based on the diagnosis results. The electrical stimulation needles, micro-phototherapy units and local thermal therapy patches in the multimodal stimulation sub-module work together to achieve precise treatment. The adaptive closed-loop cloud platform is combined with the AI ​​large model to dynamically adjust treatment parameters based on real-time monitoring data. Doctors can also make manual adjustments to ensure that the treatment plan meets individual needs and improves treatment outcomes.

[0017] The DC-DC converter of the battery power management module stabilizes the button battery voltage at 3.6V to ensure stable operation of each module. A single button battery can be used continuously for more than 30 days. The wearable fixture uses biocompatible materials to ensure stable contact of the stimulation needle array during dynamic activities.

[0018] The phototherapy unit emits near-infrared light of a specific wavelength, which penetrates the tissue and covers the target nerve area, promoting cell metabolism and nerve function recovery; the thermal therapy patch is controlled at an appropriate temperature to stimulate local blood circulation and assist in nerve regulation therapy.

[0019] By connecting the diagnosis result output module with an external display device or medical information management system, remote transmission and sharing of diagnosis results can be achieved, which facilitates consultation and case management for the medical team and improves medical efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a flow chart of the diagnosis and treatment method of the present invention; Figure 2 A schematic diagram of the device of the present invention being installed in the ear nerve area for use; Figure 3 Schematic diagram of the adaptive closed-loop neural regulation cloud platform of the present invention; Figure 4 A tree diagram for quantifying the score of opioid withdrawal after use of the present invention and quantifying the severity of opioid withdrawal; Figure 5 This is a schematic diagram of the stimulation needle array of the present invention inserted into the skin before the tilt angle of the stimulation needles is adjusted; Figure 6 This is a schematic diagram of the structure of the stimulation needle array of the present invention; Figure 7 A schematic diagram of the peripheral branches of the posterior true nerve acted upon by the stimulating needle of the present invention; Figure 8 A schematic diagram of the peripheral branches of the cranial nerves V, VII, IX, and X acted upon by the stimulating needle of the present invention; Fig. 9 It is a real scene schematic diagram of the use of the device of the present invention. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] As attached Figure 2 and Figure 3 A transcutaneous nerve field vagus nerve stimulation diagnostic and therapeutic device is shown, comprising: (a) a neural signal acquisition module, configured to collect bioelectric signals, light absorption rate and temperature data of the ear nerve area, and connected to the data processing and analysis module through corresponding sensors; (b) Nerve localization module, which integrates micro-biosensors and medical imaging feedback units to locate the target cranial nerve branches in the ear in real time and verify the contact accuracy between the stimulation needle array and the nerve, including: High-precision impedance detection unit, which measures the local impedance changes of ear tissues through the stimulation needle array to identify the location of neurovascular bundles; The miniature ultrasound probe is embedded in the root of the stimulation needle, which generates local ultrasound images of the ear nerves in real time and compares them with the preset anatomical atlas to correct the implantation angle of the stimulation needle. (c) Data processing and analysis module, which receives data from the neural signal acquisition module and detection data from the neural localization module, and constructs a dynamic diagnostic map based on the patient's withdrawal symptom score (COWS), heart rate variability and skin electrical response data; uses data analysis algorithms to analyze and process the collected data, evaluate the neural status and function, and generate diagnostic results; generates personalized treatment parameters based on the diagnostic results and preset treatment rules; (d) A treatment execution module, including an electric pulse generation submodule and a multimodal stimulation submodule, wherein: The electric pulse generation submodule is configured to generate 1-10 Hz strategic variable frequency electric pulses according to the treatment parameters generated by the data processing and analysis module, and output them to the stimulation needle array through four electric pulse transmission lines; Multimodal stimulation submodules, including electrical stimulation needles, micro-phototherapy units, and localized thermal therapy patches, are used to enhance the neuromodulation effect; (e) a diagnosis result output module, which outputs the diagnosis results obtained by the data processing and analysis module in a visual manner, including but not limited to charts, images, etc., to provide diagnosis reference for medical personnel; Also includes: A battery power management module, including a battery management chipset consisting of a button battery and a DC-DC converter, wherein the button battery is used to provide power, and the DC-DC converter is used to stabilize the voltage at 3.6V; The adaptive closed-loop cloud platform connects to diagnostic and treatment equipment via Bluetooth, receives the patient's bioelectric signals, light absorption rate and temperature data in real time, and monitors and records the treatment process. During the treatment process, the treatment parameters are dynamically adjusted based on real-time monitoring data combined with the AI ​​big model. The wearable fixation device, made of biocompatible materials, includes an auricular-fitting bracket and a flexible adhesive patch to ensure stable contact of the stimulating needle array during dynamic activities.

[0023] Specifically, a transcutaneous neural field vagus nerve stimulation diagnostic and treatment device includes a therapeutic device body, which is equipped with a nerve acquisition module, a nerve positioning module, a data processing and analysis module, a treatment execution module, a diagnosis result output module, an adaptive closed-loop cloud platform connected via Bluetooth, and a wearable fixing device connected to the outside of the therapeutic device body, wherein each stimulation needle end is connected to a micro-robotic arm for adjusting the angle.

[0024] In the specific implementation, in actual operation, the patient wears a device that integrates various sensors, the high-sensitivity electrodes of the neural signal acquisition module, the specific wavelength light emitting and receiving device, and the micro-thermistor, respectively, to collect the bioelectric signals, light absorption rate and temperature data of the ear nerve area, and transmit them to the data processing and analysis module. The stimulation needle array of the neural positioning module contacts the ear tissue, the high-precision impedance detection unit measures the local impedance change to identify the location of the neurovascular bundle, and the micro-ultrasound probe generates an ultrasound image, which is compared with the preset anatomical map to correct the implantation angle of the stimulation needle. The data processing and analysis module receives various types of data, combines the patient's withdrawal symptom score, heart rate variability and skin galvanic response data to construct a dynamic diagnostic map, evaluates the neural state and function through algorithm analysis, and generates diagnostic results and personalized treatment parameters. The electric pulse generation submodule of the treatment execution module generates 1-10Hz variable frequency electric pulses according to the parameters, which are transmitted to the stimulation needle array through the transmission line. The electric stimulation needles, micro phototherapy units and local thermal therapy patches of the multimodal stimulation submodule work together. The diagnostic result output module presents the diagnostic results to medical personnel in the form of charts, images and other visual forms. It uses different sensors to collect physiological data, locates nerves based on tissue impedance characteristics and ultrasonic imaging technology, and uses data analysis algorithms to evaluate nerve conditions. It formulates personalized treatment plans based on the diagnostic results, uses electrical, optical and thermal multimodal stimulation to treat ear nerves, and provides diagnostic references for medical personnel. At the same time, the diagnostic and treatment equipment is connected to the adaptive closed-loop cloud platform via Bluetooth, and the equipment continuously transmits the patient's bioelectric signals, light absorption rate and temperature data to the cloud platform. The cloud platform uses AI large models to analyze data, adjusts treatment parameters in real time during treatment, and records the entire treatment process. The auricle fitting bracket and flexible adhesive stickers of the wearable fixture fit tightly to the patient's ears, ensuring that the stimulation needle array can stably contact the ears when the patient is moving. During the entire operation process, the battery power management module and the DC-DC converter always adjust the voltage of the button battery so that a stable 3.6V voltage can be provided in the voltage range of 1.8V-4.2V, avoiding the linear decrease in voltage caused by the button battery as the use time increases. The voltage is stabilized at 3.6V through the DC-DC converter to ensure the stability of the operation of each module, which can improve the treatment effect and stability, and ensure that a single button battery can be used continuously for more than 30 days.

[0025] In this way, Bluetooth technology is used to realize data transmission between the device and the cloud platform. The AI ​​large model optimizes treatment parameters based on real-time data to improve treatment effects. The wearable fixation device uses biocompatible materials and reasonable design to ensure the stable operation of the stimulation needle array and ensure the continuity and stability of the treatment process.

[0026] The phototherapy unit emits near-infrared light with a wavelength of 630-850nm and a penetration depth of 2-5mm, covering the target nerve area; the thermal therapy patch controls the temperature at 38-42°C through a micro-Peltier element to stimulate local blood circulation.

[0027] In specific implementation, the micro-phototherapy unit of the multimodal stimulation submodule is equipped with a specific light-emitting element to emit near-infrared light of 630-850nm, and the light is focused on the target nerve area. The micro-Peltier element of the local thermal therapy patch maintains a stable temperature of 38-42°C under the control of the control circuit, so that near-infrared light of a specific wavelength can penetrate the tissue to reach the target nerve area, promote cell metabolism and nerve function recovery; the temperature of 38-42°C can dilate local blood vessels, accelerate blood circulation, improve the nutrition supply of nerves, and assist in nerve regulation treatment.

[0028] The bioelectric signal sensor in the neural signal acquisition module adopts a high-sensitivity electrode, which can accurately collect weak neural electrical signals; the light absorption rate sensor adopts a light emitting and receiving device of a specific wavelength to detect the light absorption of the target area; the temperature sensor adopts a micro-thermistor to quickly and accurately measure the local temperature.

[0029] During specific implementation, in the neural signal acquisition module, high-sensitivity electrodes are made of special materials and processes, and are in close contact with the ear skin to collect bioelectric signals; the light absorption rate sensor emits and receives light signals at a set wavelength and calculates the light absorption; the micro-thermistor senses local temperature changes and converts these data into electrical signals for transmission, so that the high-sensitivity electrodes can capture weak neural electrical signals by utilizing their special materials and structures; the light absorption rate sensor detects the absorption degree of light of a specific wavelength in the target area based on the principle of light absorption, reflecting the tissue characteristics; the micro-thermistor measures the temperature quickly and accurately based on the thermal sensitivity characteristics and converts it into electrical signals, providing data for subsequent analysis.

[0030] The data processing and analysis module uses a machine learning algorithm to extract features and classify the collected data, thereby improving the accuracy and reliability of diagnosis; and can adaptively adjust the analysis model and parameters according to the individual differences of different patients.

[0031] In specific implementation, the data processing and analysis module pre-stores a variety of machine learning algorithm models. After receiving the collected data, the model automatically extracts data features and classifies them. According to the individual data differences of different patients, the algorithm automatically adjusts the model parameters to improve the accuracy and reliability of diagnosis. In this way, the machine learning algorithm can learn rules from a large amount of data and effectively analyze the collected complex physiological data. By continuously optimizing the model parameters and adapting to the physiological characteristics of different patients, the accuracy of diagnosis is improved, providing a reliable basis for personalized treatment.

[0032] The diagnosis result output module is connected to an external display device or a medical information management system to achieve remote transmission and sharing of diagnosis results, facilitating consultation and case management by the medical team.

[0033] During specific implementation, the diagnosis result output module is connected to an external display device (such as a computer monitor) or a medical information management system through a wired or wireless network interface, and the diagnosis results are transmitted in a standard data format for easy viewing and sharing by medical personnel. In this way, network communication technology is used to achieve remote transmission and sharing of diagnosis results, break down information barriers, facilitate collaborative consultation among medical teams, improve medical efficiency, and facilitate case management and the accumulation and analysis of medical data.

[0034] The stimulation needle array includes a titanium alloy disc, a disc cover, a stimulation needle and a micro-mechanical arm. A plurality of micro-mechanical arms are installed above the titanium alloy disc, each of the micro-mechanical arms is connected to a stimulation needle. The disc cover is installed on the titanium alloy disc, and the bioelectric signal sensor is installed at the needle tip of the stimulation needle to receive the bioelectric signal. Among them, as attached Figure 6 As shown, the number of stimulation needles includes single needle, four needles, six needles and eight needles, and the needle head of the stimulation needle is trapezoidal, the diameter of the tail contacting the connection between the titanium alloy disc and the micro-robotic arm is 0.4 mm, the needle tip is 0.05 mm, and the needle length is 2.00 mm.

[0035] When implementing it specifically, Figure 5 As shown, a stimulation needle array is composed of multiple groups of 2mm long body-shaped stimulation needles with a root diameter of 0.4mm. During use, a high-precision impedance detection unit can be used to measure the local impedance changes of the ear tissue through the stimulation needle array to identify the location of the neurovascular bundle, and cooperate with the miniature ultrasound probe embedded in the root of the stimulation needle to generate a local ultrasound image of the ear nerve in real time, and compare it with the preset anatomical map to correct the implantation angle of the stimulation needle. The biosignal sensor receives the detection information, and then feedback controls the micro-robotic arm to adjust the inclination angle of the corresponding stimulation needle, so that the stimulation needle tip can accurately contact the ganglion tissue to ensure the effectiveness of low-frequency stimulation, thereby improving the pain relief effect.

[0036] Under the doctor supervision mode, the adaptive closed-loop cloud platform allows manual adjustment of AI-generated treatment parameters to ensure treatment safety.

[0037] During the specific implementation, the adaptive closed-loop cloud platform sets up an entrance to the doctor supervision mode. After logging in, the doctor can view the treatment parameters generated by AI and manually adjust the parameters based on clinical experience and the actual situation of the patient. The adjusted parameters are fed back to the diagnostic and treatment equipment in real time. Based on AI technology, the doctor's subjective judgment right is retained, and the AI's data analysis capabilities and the doctor's clinical experience are combined to ensure that the treatment parameters are both scientific and meet the individual needs of patients, thereby ensuring the safety and effectiveness of the treatment process.

[0038] like Figure 1 As shown, a transcutaneous nerve field vagus nerve stimulation diagnosis and treatment method using a transcutaneous nerve field stimulation diagnosis and treatment device for treating drug addiction comprises: Step 1: Collect bioelectric signals, light absorption rate and temperature data of the ear nerve area through the neural signal acquisition module; Step 2: Use the impedance detection and ultrasound imaging of the nerve localization module to determine the location and status of the target cranial nerve branches in the ear; Step 3: The collected data is transmitted to the data processing and analysis module, a dynamic diagnostic map is constructed and data analysis is performed to evaluate the nerve status and function and generate diagnostic results; personalized treatment parameters are generated based on the diagnostic results; Step 4: Output the diagnosis result through the diagnosis result output module; Step 5: Start the treatment execution module and perform multimodal coordinated stimulation according to the generated treatment parameters, with synchronous action of electric pulses, near-infrared light and local hyperthermia; Step 6: Monitor the patient’s physiological data in real time through an adaptive closed-loop cloud platform, dynamically adjust treatment parameters, and generate efficacy reports in real time.

[0039] In specific implementation, the neural signal acquisition module is first started to collect data; then the neural positioning module conducts impedance detection and ultrasonic imaging to determine the location of the nerve; the collected data is transmitted to the data processing and analysis module for processing and diagnosis to generate treatment parameters; after the diagnosis results are output, the treatment execution module is started for multi-modal collaborative stimulation; during the treatment process, the adaptive closed-loop cloud platform monitors the data in real time and generates a real-time efficacy report, so as to follow the process from data collection, analysis and diagnosis, treatment implementation to effect monitoring, forming a complete diagnosis and treatment closed loop. Through the collaborative work of multiple links, accurate diagnosis and personalized treatment of drug-addicted patients can be achieved, and the treatment plan can be continuously optimized to improve the treatment effect.

[0040] Specifically, since the ear contains cranial nerves V, VII, IX, and X, they are directly connected to the brain, and branches of the greater and lesser occipital nerves are directly connected to the cervical spine. There are distinct areas on the dorsal and ventral sides of the auricle that contain a large number of cranial nerves, peripheral nerves, arterial branches, and neurovascular bundles.

[0041] The superior temporal artery and posterior auricular artery in the external ear enter from the front (ventral) and back (dorsal) sides of the ear. These arteries converge at the earlobe and eventually branch into the cell layer, forming a complex interconnected network with a branching pattern that follows the laws of the Mandelbrot set.

[0042] Therefore, if Figure 2 As shown, when the device is worn on the head through a wearable fixing device and each stimulation needle array is attached to the approximate position of the corresponding nerve, the bioelectric signals, light absorption rate and temperature data of the ear nerve area are collected respectively through the high-sensitivity electrodes, specific wavelength light emitting and receiving devices, and micro-thermistors of the neural signal acquisition module, and transmitted to the data processing and analysis module.

[0043] As attached Figure 7 , Attachment Figure 8 and attached Fig. 9 As shown, the stimulation needle array of the nerve positioning module contacts the ear tissue, the high-precision impedance detection unit measures the local impedance change to identify the location of the neurovascular bundle, and the micro-ultrasound probe generates an ultrasonic image to clarify the location and status of the peripheral branches V, VII, IX, and X of the cranial nerves and the peripheral branches of the occipital nerves. Then, after comparing with the preset anatomical atlas, the stimulation needle implantation angle is corrected so that each stimulation needle can accurately connect with the corresponding nerve. Then, various types of data are received through the data processing and analysis module, and a dynamic diagnostic atlas is constructed in combination with the patient's withdrawal symptom score, heart rate variability, and skin electrical response data. The algorithm analyzes and evaluates the nerve state and function to generate diagnostic results and personalized treatment parameters. The electric pulse generation submodule of the treatment execution module generates 1-10Hz variable frequency electric pulses according to the parameters, which are transmitted to the stimulation needle array through the transmission line. The electric stimulation needles, micro phototherapy units, and local thermal therapy patches of the multimodal stimulation submodule work together to perform electric stimulation treatment. The diagnostic result output module presents the diagnostic results to medical personnel in visual forms such as charts and images, so as to collect physiological data using different sensors, locate nerves based on tissue impedance characteristics and ultrasonic imaging technology, evaluate nerve conditions with the help of data analysis algorithms, formulate personalized treatment plans based on the diagnostic results, and use electrical, optical, and thermal multimodal stimulation to perform therapeutic interventions on the ear nerves, thereby completing the diagnosis of whether the stimulation needles are aligned at each nerve position, and adjusting the angle of the stimulation needles according to the micro-robotic arm, and then performing automatic electrical stimulation treatment, thereby improving the effectiveness of treatment and helping to relieve pain symptoms.

[0044] In specific implementation, during the treatment of opioid dependence in patients, adaptive strategic electrical pulses emitted by stimulating electroacupuncture stimulate the cranial nerve branches. After the instrument is installed in the ear, continuous electrical stimulation is required for 120 hours. The neuroregulatory cloud platform dynamically adjusts the electrical pulses. Individualized targeted interventions are implemented on patients by regularly monitoring the feedback values ​​of the "Clinical Opioid Withdrawal Scale". In addition, effective intervention in opioid withdrawal symptoms helps stabilize the patient's mood and lays the foundation for motivating patients to stop using opioids, motivating patients to stop opioid dependence and move to long-term rehabilitation. Each patient has a different electrical pulse stimulation intensity, which is achieved by providing more electrical stimulation options. Multiple intervention stimulation cycles can be performed with an interval of 2 days in between.

[0045] Among them, during use, the data monitoring module will monitor the opioid withdrawal value, and the data analysis module will evaluate the opioid withdrawal value.

[0046] As attached Figure 4 Research data showed that within 20 minutes of using the device, COWS scores dropped by an average of 72%. After 60 minutes of use, the scores continued to drop, with an average drop of 91%. After 5 days of treatment, COWS scores dropped by an average of 98%. At the same time, patients' anxiety levels improved by 45%. Vagus nerve stimulation reduced sympathetic nerve activity, thereby reducing physical withdrawal symptoms such as sweating, muscle and abdominal cramps, diarrhea, joint pain, tremors, and increased heart rate.

[0047] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A transcutaneous nerve field vagus nerve stimulation diagnostic and therapeutic device, characterized in that: include: (a) a neural signal acquisition module, configured to collect bioelectric signals, light absorption rate and temperature data of the ear nerve area, and connected to the data processing and analysis module through corresponding sensors; (b) Nerve localization module, which integrates micro-biosensors and medical imaging feedback units to locate the target cranial nerve branches in the ear in real time and verify the contact accuracy between the stimulation needle array and the nerve, including: High-precision impedance detection unit, which measures the local impedance changes of ear tissues through the stimulation needle array to identify the location of neurovascular bundles; The miniature ultrasound probe is embedded in the root of the stimulation needle, which generates local ultrasound images of the ear nerves in real time and compares them with the preset anatomical atlas to correct the implantation angle of the stimulation needle. (c) A data processing and analysis module receives data from the neural signal acquisition module and detection data from the neural localization module, and constructs a dynamic diagnostic map based on the patient's withdrawal symptom score, heart rate variability, and skin electrical response data; uses a data analysis algorithm to analyze and process the collected data, evaluate the neural status and function, and generate a diagnostic result; generates personalized treatment parameters based on the diagnostic results and preset treatment rules; (d) A treatment execution module, including an electric pulse generation submodule and a multimodal stimulation submodule, wherein: The electric pulse generation submodule is configured to generate 1-10 Hz strategic variable frequency electric pulses according to the treatment parameters generated by the data processing and analysis module, and output them to the stimulation needle array through four electric pulse transmission lines; Multimodal stimulation submodules, including electrical stimulation needles, micro-phototherapy units, and localized thermal therapy patches, are used to enhance the neuromodulation effect; (e) A diagnosis result output module outputs the diagnosis results obtained by the data processing and analysis module in a visual manner, including charts and images, to provide diagnostic references for medical personnel.

2. A transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device according to claim 1, characterized in that: Also includes: A battery power management module, including a battery management chipset consisting of a button battery and a DC-DC converter, wherein the button battery is used to provide power, and the DC-DC converter is used to stabilize the voltage at 3.6V; The adaptive closed-loop cloud platform connects to diagnostic and treatment equipment via Bluetooth, receives the patient's bioelectric signals, light absorption rate and temperature data in real time, and monitors and records the treatment process. During the treatment process, the treatment parameters are dynamically adjusted based on real-time monitoring data combined with the AI ​​big model. Wearable fixation device made of biocompatible materials, consisting of an ear-fitting frame and a flexible adhesive patch.

3. The transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device according to claim 1, characterized in that: The micro phototherapy unit emits near-infrared light with a wavelength of 630-850nm and a penetration depth of 2-5mm, covering the target nerve area; the thermal therapy patch controls the temperature at 38-42°C through a micro Peltier element to stimulate local blood circulation.

4. The transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device according to claim 1, characterized in that: The bioelectric signal sensor in the neural signal acquisition module adopts a high-sensitivity electrode; the light absorption rate sensor adopts a light emitting and receiving device of a specific wavelength to detect the light absorption of the target area; and the temperature sensor adopts a micro-thermistor.

5. The transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device according to claim 1, characterized in that: The data processing and analysis module uses a machine learning algorithm to extract features and classify the collected data; and can adaptively adjust the analysis model and parameters according to the individual differences of different patients.

6. The transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device according to claim 1, characterized in that: The diagnosis result output module is connected to an external display device or a medical information management system to achieve remote transmission and sharing of the diagnosis results.

7. The transcutaneous neural field vagus nerve stimulation diagnostic and therapeutic device according to claim 1, characterized in that: The stimulation needle array includes a titanium alloy disc, a disc cover, a stimulation needle and a micro-mechanical arm. A plurality of micro-mechanical arms are installed above the titanium alloy disc, each of the micro-mechanical arms is connected to a stimulation needle. The disc cover is installed on the titanium alloy disc, and the bioelectric signal sensor is installed at the needle tip of the stimulation needle to receive the bioelectric signal. Among them, the number of stimulation needles includes single needle, four needles, six needles and eight needles, and the needle head of the stimulation needle is trapezoidal, the diameter of the tail contacting the connection between the titanium alloy disc and the micro-robotic arm is 0.4 mm, and the needle tip is 0.05 mm.

8. A transcutaneous nerve field vagus nerve stimulation diagnosis and treatment method based on the transcutaneous nerve field vagus nerve stimulation diagnosis and treatment device according to any one of claims 1 to 7, characterized in that: include: Step 1: Collect bioelectric signals, light absorption rate and temperature data of the ear nerve area through the neural signal acquisition module; Step 2: Use the impedance detection and ultrasound imaging of the nerve localization module to determine the location and status of the target cranial nerve branches in the ear; Step 3: The collected data is transmitted to the data processing and analysis module, a dynamic diagnostic map is constructed and data analysis is performed to evaluate the nerve status and function and generate diagnostic results; personalized treatment parameters are generated based on the diagnostic results; Step 4: Output the diagnosis result through the diagnosis result output module; Step 5: Start the treatment execution module and perform multimodal coordinated stimulation according to the generated treatment parameters, with synchronous action of electric pulses, near-infrared light and local hyperthermia; Step 6: Monitor the patient’s physiological data in real time through an adaptive closed-loop cloud platform, dynamically adjust treatment parameters, and generate efficacy reports in real time.

Images