Non-invasive closed-loop ear vagus nerve stimulator for improving cerebral apoplexy and use method

Abstract

The invention relates to the technical field of medical equipment, provides a non-intrusive closed-loop ear vagus nerve stimulator for improving cerebral apoplexy and a use method, and aims to improve the symptoms of a patient by stimulating the ear vagus nerve in a conchae area. The device integrates an electrical stimulation electrode, a host and a closed-loop feedback module, monitors brain blood flow changes and other physiological parameters of a patient in real time, and automatically adjusts stimulation parameters through an intelligent algorithm to realize personalized treatment. A microprocessor, a multi-mode monitoring unit and a data fusion analysis unit are arranged in the host, and accurate and efficient treatment is ensured. In addition, the equipment supports remote intelligent monitoring and guidance, a treatment plan can be remotely adjusted, and the treatment effect is improved. A user interaction interface is friendly, and operation of patients and medical staff is facilitated. The stimulator is light in design, the conductive silica gel electrode is adopted, through real-time monitoring and intelligent adjustment, accurate and efficient treatment is provided for a patient, the comfort level and treatment convenience of the patient are ensured, and a safe and effective rehabilitation scheme is provided for the stroke patient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, in particular to a non-invasive closed-loop ear vagus nerve stimulator for improving cerebral stroke, and also to a method for using the non-invasive closed-loop ear vagus nerve stimulator for improving cerebral stroke. Background Art

[0002] Stroke, commonly known as "stroke", is a common cerebrovascular disease with high morbidity, high disability and high mortality. With the advancement of medical technology, the survival rate of stroke patients has been significantly improved, but many survivors still face long-term physical dysfunction, such as hemiplegia, language disorders, etc. Therefore, rehabilitation treatment of stroke is particularly important.

[0003] At present, rehabilitation treatment for stroke mainly includes physical therapy, occupational therapy, speech therapy and other methods. However, these treatment methods are often complicated and long-term, requiring the patient and family members' patient cooperation. At the same time, due to the different conditions and physical conditions of each patient, there are also large individual differences in treatment effects.

[0004] In recent years, neuromodulation technology has shown great potential in stroke rehabilitation treatment. Among them, transcutaneous auricular vagus nerve stimulation (taVNS) has attracted widespread attention as an emerging non-invasive neuromodulation method.

[0005] Auricular vagus nerve stimulation stimulates the vagus nerve in the ear, thereby affecting the function of the central nervous system, thereby achieving rehabilitation treatment for stroke patients. Studies have shown that taVNS can improve the patient's cerebral blood flow, promote the recovery of nerve function, alleviate the patient's symptoms, and improve the quality of life.

[0006] Although auricular vagus nerve stimulation has shown significant effects in stroke rehabilitation, existing stimulation devices still have some limitations. Most devices use an open-loop design, that is, the stimulation parameters are preset and cannot be adjusted according to the patient's real-time physiological state. This design cannot fully utilize the potential of taVNS and limits the optimization of treatment effects.

[0007] In addition, the stimulation parameters of existing devices are often relatively fixed, lacking personalized treatment plans. Each patient's condition and physical condition are unique, and fixed stimulation parameters may not meet the needs of all patients, thus affecting the treatment effect.

[0008] Therefore, developing a closed-loop auricular vagus nerve stimulator that can monitor the patient's physiological state in real time and adjust the stimulation parameters accordingly is of great significance for improving the rehabilitation treatment effect of stroke. This device will be able to provide personalized treatment plans based on the patient's real-time feedback, thereby maximizing the rehabilitation treatment potential of taVNS. Summary of the invention

[0009] One of the purposes of the present invention is to provide a non-invasive closed-loop ear vagus nerve stimulator for improving stroke, aiming to provide stroke patients with personalized, efficient and safe rehabilitation treatment plans through real-time monitoring and closed-loop feedback mechanism, thereby significantly improving their quality of life and neurological function recovery level.

[0010] To solve the above technical problems, the present invention discloses a non-invasive closed-loop ear vagus nerve stimulator for improving stroke, comprising electrical stimulation electrodes, a host, and a closed-loop feedback module. The electrical stimulation electrodes are non-invasively placed in the cymba auricularis region of the patient to stimulate the ear vagus nerve.

[0011] The host computer has a built-in microprocessor for controlling the stimulation parameters (current intensity and frequency) of the electrical stimulation electrodes;

[0012] The host is also equipped with a multimodal monitoring unit and a data fusion analysis unit to conduct comprehensive analysis of the multiple physiological parameters received to monitor and evaluate the patient's physiological state and treatment effect.

[0013] The multimodal monitoring unit includes a real-time monitoring module for real-time monitoring of changes in the patient's cerebral blood flow; the real-time monitoring module adopts a near-infrared brain function imaging monitoring module, which is integrated into the host or connected to the host as a split module for communication.

[0014] The data fusion analysis unit in the host computer fuses multiple physiological parameters using a weighted average method or a Kalman filter algorithm to generate a comprehensive physiological evaluation index.

[0015] The closed-loop feedback module is based on the cerebral blood flow data monitored by the real-time monitoring module, and according to the real-time monitored cerebral blood flow conditions, the closed-loop feedback module automatically adjusts the stimulation parameters (current intensity and / or frequency) of the electrical stimulation electrode to optimize the treatment effect and achieve closed-loop control.

[0016] In addition to the above-mentioned technical solutions, this application also makes improvements in the following aspects:

[0017] In some embodiments, the real-time monitoring module is integrated with a heart rate sensor, a blood pressure sensor, and a blood oxygen saturation sensor, which are respectively used to detect and monitor the patient's heart rate HR, blood pressure BP, and blood oxygen saturation SpO2; each sensor is connected to the host via wired or wireless means to transmit the monitoring data to the host in real time.

[0018] In some embodiments, the data fusion analysis unit uses the following formula to perform a comprehensive analysis on the received multiple physiological parameters, and the calculation formula of the comprehensive physiological state index CPI is:

[0019] I=w1×HR+w2×BP+w3×SpO2

[0020] Among them, w1, w2, and w3 are weight coefficients of each physiological parameter, which are set according to clinical experience and the specific conditions of the patient.

[0021] In some embodiments, the real-time monitoring module is electrically connected to the host and transmits the real-time monitored cerebral blood flow data to the host for analysis and processing.

[0022] In some embodiments, the closed-loop feedback module is electrically connected to a microprocessor in a host via a wired or wireless manner.

[0023] The host's microprocessor automatically adjusts the parameters of electrical stimulation, including the intensity and frequency of stimulation, through a built-in algorithm based on the real-time cerebral blood flow data provided by the near-infrared brain function imaging monitoring module.

[0024] In some embodiments, the closed-loop feedback module has a built-in machine learning or deep learning algorithm unit.

[0025] The algorithm unit automatically calculates and adjusts the stimulation parameters of the electrical stimulation electrodes using the following formulas based on the real-time physiological data received by the host and the historical treatment data stored:

[0026] Stimulus intensity adjustment formula:

[0027] I n+1 =I n +α×(CPI target -CPI current )

[0028] Among them, I n+1 is the adjusted stimulus intensity, I n is the current stimulus intensity, α is the learning rate (0<α<1), CPI target The target comprehensive physiological status index, CPI current It is the current comprehensive physiological status index.

[0029] The algorithm unit automatically calculates and adjusts the stimulation parameters of the electrical stimulation electrode using the above formula through the real-time physiological data received by the host and the stored historical treatment data. The stimulation parameters include current intensity, frequency, and waveform. The output of the electrical stimulation electrode is controlled in real time through the microprocessor in the host. The adjustment of the frequency F and the waveform W is automatically performed based on the preset rules and the stimulation intensity adjustment results.

[0030] The adjusted stimulation parameters are used to control the output of the electrical stimulation electrodes in real time through the microprocessor in the host.

[0031] In some embodiments, the initial stimulation intensity of the electrical stimulation electrode is set to 0.5 mA to 2 mA, and the initial stimulation intensity (mA) is set specifically according to the following formula:

[0032] I init =0.5+S max -S min 1.5×(SS min )

[0033] Among them, S is the severity score of the patient's condition, S min and S max are the minimum and maximum values ​​of the disease severity score, respectively;

[0034] During operation, based on the feedback data from the real-time monitoring module, the algorithm unit in the host uses the stimulation intensity adjustment formula to automatically calculate and adjust the stimulation intensity, with each adjustment amplitude not exceeding 0.5mA.

[0035] In some embodiments, the non-invasive closed-loop auricular vagus nerve stimulator for improving stroke further comprises a remote intelligent monitoring and guidance system.

[0036] The host has a built-in wireless communication module (such as Bluetooth, Wi-Fi, etc.) to establish a communication connection with the telemedicine platform or doctor's workstation;

[0037] The wireless communication module follows the medical data security protocol and encrypts and transmits the patient's physiological data, treatment data and device status to the telemedicine platform or doctor's workstation;

[0038] The telemedicine platform or doctor workstation can display the received data in real time and provide remote treatment plan adjustment suggestions based on the following formula.

[0039] In some embodiments, the treatment plan adjustment suggestion formula is:

[0040] ΔP=f(I t ,I ta ,P t )

[0041] Where ΔP is the adjustment amount of the treatment plan, f is a function set according to clinical experience and the specific situation of the patient, P t For current treatment plan.

[0042] In some embodiments, the host further comprises a user interaction interface, wherein the user interaction interface comprises a touch screen display and physical buttons.

[0043] The touch screen display screen is used to display treatment parameters, device status, check treatment progress and receive feedback on the working status of the device, and supports patients or medical staff to set parameters and view data through touch operations.

[0044] The physical buttons include a power switch, a power status indicator light, a working status indicator light, and an emergency stop button, which are used to provide working status feedback or adjustment of the working status of the device.

[0045] The user interaction interface is connected to the microprocessor in the host computer via a wired or wireless method to achieve real-time interaction of information.

[0046] In some embodiments, the electrical stimulation electrodes are made of conductive silicone material and are non-invasively adhered to the patient's cymba concha area through medical-grade adhesive; the host is configured as a wearable headphone structure with a built-in rechargeable lithium battery; the electrical stimulation electrodes are connected to the host through low-impedance, highly flexible wires to ensure the stability of signal transmission and the comfort of the patient.

[0047] In some embodiments, the electrical stimulation electrode automatically and gradually increases the intensity of electrical stimulation according to feedback from the near-infrared brain function imaging monitoring module until a preset therapeutic effect or a therapeutic effect determined according to real-time monitoring data is achieved.

[0048] In some embodiments, the host further includes a wireless communication module, a data storage unit and a transmission module, wherein the data storage unit and the transmission module are used to record the patient's treatment data and effects, and facilitate remote monitoring and evaluation by doctors.

[0049] The wireless communication module is used to communicate with a remote medical device or a doctor's workstation so as to remotely monitor the patient's treatment progress and adjust stimulation parameters.

[0050] The data storage unit is connected to the wireless communication module through the microprocessor in the host to realize remote transmission of data. Specifically, the following formula is used for data compression and transmission:

[0051] text compressed data = Comp (original data)

[0052] Comp is a data compression function, which ensures efficient data transmission under limited bandwidth.

[0053] In some embodiments, the wireless communication module built into the host uses the following formula to perform data encryption transmission:

[0054] text encrypted data = Enc (original data, key)

[0055] Among them, Enc is the encryption function, the original data includes the patient's physiological data, treatment data and device status, and the key is the preset encryption key to ensure the security of data transmission.

[0056] Another object of the present invention is to provide a method for improving stroke by using a non-invasive closed-loop ear vagus nerve stimulator, the specific method of use is as follows:

[0057] S1: Place the electrical stimulation electrode in the cymba concha area of ​​the patient, ensuring that the electrical stimulation electrode is in close contact with the skin;

[0058] S2: Start the device through the power switch on the host, and the system automatically initializes, including parameter setting and device self-test;

[0059] S3: Using the near-infrared brain function imaging module to monitor the cerebral blood flow in real time, and transmitting the detected data to the host microprocessor in real time;

[0060] S4: Based on the real-time monitored cerebral blood flow data, the host automatically adjusts the current intensity and / or frequency of the electrical stimulation electrodes according to the preset algorithm, and then dynamically adjusts the stimulation parameters to optimize the treatment effect.

[0061] In some embodiments, before starting the device, an initial current intensity is set to a current value between 0.5 mA and 2 mA, and is gradually adjusted according to the patient's tolerance and treatment progress.

[0062] In some embodiments, the host provides visual feedback, displaying the working status and treatment effect of the device through a work display light, so that patients and doctors can understand the progress of treatment in a timely manner.

[0063] The non-invasive closed-loop ear vagus nerve stimulator for improving stroke proposed in the present invention provides an efficient, safe and personalized treatment plan for stroke patients by integrating advanced electrical stimulation technology, multimodal monitoring, data fusion analysis and closed-loop feedback control. In summary, the present invention has at least one of the following beneficial effects by adopting the above technical solution:

[0064] 1. Precision treatment and closed-loop control

[0065] Real-time monitoring and feedback: Through the near-infrared brain function imaging monitoring module, the device can monitor the patient's cerebral blood flow changes in real time, providing a direct physiological indicator basis for treatment. The closed-loop feedback module automatically adjusts the stimulation parameters of the electrical stimulation electrodes based on these real-time data to ensure that the treatment is always in the best state.

[0066] Personalized adjustment: Based on the patient's specific condition and physiological state, the device automatically calculates and adjusts the stimulation parameters through a built-in algorithm to achieve personalized treatment. This precision treatment helps improve treatment effects and reduce unnecessary side effects.

[0067] 2. Multimodal monitoring and comprehensive assessment

[0068] Comprehensive monitoring: The real-time monitoring module not only monitors cerebral blood flow, but also integrates multiple physiological parameter monitoring functions such as heart rate, blood pressure, and blood oxygen saturation, providing comprehensive physiological status information. This helps doctors understand the patient's physical condition more comprehensively and provides a scientific basis for the formulation and adjustment of treatment plans.

[0069] Comprehensive evaluation: The data fusion analysis unit uses weighted average method or Kalman filtering algorithm to fuse multiple physiological parameters into a comprehensive physiological assessment index (CPI), providing an objective and quantitative indicator for the evaluation of treatment effects.

[0070] 3.Intelligent and remote monitoring

[0071] Intelligent adjustment: The closed-loop feedback module has a built-in machine learning or deep learning algorithm unit that can continuously optimize treatment strategies and improve treatment efficiency based on real-time physiological data and historical treatment data. This intelligent adjustment makes treatment more flexible and efficient.

[0072] Remote monitoring and guidance: The device has a built-in wireless communication module, which establishes a communication connection with the telemedicine platform or doctor's workstation to achieve remote monitoring and guidance. Doctors can view the patient's physiological data and treatment progress in real time, and adjust the treatment plan as needed to provide patients with more timely and effective treatment services.

[0073] 4. User-friendly and portable design

[0074] Non-invasive treatment: The electrical stimulation electrodes are made of conductive silicone material and are non-invasively attached to the patient's cymboa concha area through medical-grade adhesive, ensuring the comfort and safety of the treatment.

[0075] Portable design: The main unit is designed as a lightweight waist bag or bracelet with a built-in rechargeable lithium battery, which is convenient for patients to carry and use. At the same time, the user interface provides an intuitive and easy-to-use operation experience, supporting patients or medical staff to set parameters and view data through touch operation.

[0076] 5. Data security and privacy protection

[0077] Encrypted transmission: The wireless communication module follows the medical data security protocol and adopts encrypted transmission technology to ensure the security and privacy of patient data. This helps to enhance patients' trust in treatment and promote good communication between doctors and patients.

[0078] Data compression and efficient transmission: The data storage unit realizes the function of efficient data transmission under limited bandwidth through data compression and transmission modules. This helps to reduce delays and packet loss during data transmission and improve the reliability and stability of data transmission.

[0079] 6. Visual feedback and timely treatment adjustment

[0080] Visual feedback: The host provides visual feedback function, which displays the working status and treatment effect of the device through the working indicator light. This helps patients and doctors to understand the progress of treatment in a timely manner and make timely adjustments as needed.

[0081] Dynamic adjustment: Based on the feedback data from the real-time monitoring module, the device can automatically and gradually increase the intensity of electrical stimulation until the preset therapeutic effect or the therapeutic effect determined based on the real-time monitoring data is achieved. This dynamic adjustment mechanism helps to improve the flexibility and effectiveness of treatment.

[0082] In summary, the non-invasive closed-loop ear vagus nerve stimulator for improving stroke proposed in the present invention provides an efficient, safe and personalized treatment plan for stroke patients through advanced technical means such as precise stimulation, multimodal monitoring, closed-loop feedback, and remote intelligent monitoring. Its beneficial effects are not only reflected in the improvement of the treatment effect, but also in the improvement of patient experience, the intelligence of the treatment process, and the security protection of data, etc., which has important clinical value and social significance. These advantages not only improve the treatment effect of stroke and the comfort of patients, but also provide doctors with a more comprehensive and objective means of treatment evaluation, which is helpful to promote the further development of stroke treatment technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] The drawings described herein are used to provide further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0084] Figure 1 This is a schematic diagram of the overall structure of the non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to the present invention;

[0085] Figure 2 This is the control principle diagram of the present invention;

[0086] Figure 3 This is a near infrared spectrum detection characterization diagram before treatment of the present invention;

[0087] Figure 4 This is a near infrared spectrum detection characterization diagram after treatment of the present invention;

[0088] Figure 5 for Figure 3 and Figure 4 Near infrared spectrum detection comparison chart.

[0089] The numbers in the figure are as follows:

[0090] 1. Electrical stimulation electrodes; 2. Host; 3. Power switch; 4. Charging port; 5. Power status indicator light; 6. Working status indicator light. DETAILED DESCRIPTION

[0091] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. The description of the exemplary embodiments is merely illustrative and is by no means intended to limit the present invention and its application or use. The present invention can be implemented in other different forms and is not limited to the embodiments described herein.

[0092] It should be noted that those skilled in the art explicitly and implicitly understand that the embodiments described in the present invention can be combined with other embodiments without conflict. Unless otherwise defined, the technical terms or scientific terms involved in the present invention should have the common meanings understood by people with ordinary skills in the technical field to which the present invention belongs.

[0093] The words "a", "an", "a", "the" and the like involved in the present invention do not indicate quantity limitation and may indicate singular or plural. The terms "include", "comprises", "has" and any variations thereof involved in the present invention are intended to cover non-exclusive inclusions; the terms "first", "second", "third" and the like involved in the present invention are merely used to distinguish similar objects and do not represent a specific ordering of the objects.

[0094] When it comes to method steps, the sequence illustrated in this document represents an exemplary solution, but does not mean a limitation on the sequence.

[0095] There are still some limitations in stimulation devices. Most devices adopt an open-loop design, that is, the stimulation parameters are preset and cannot be adjusted according to the patient's real-time physiological state. This design method cannot fully utilize the potential of taVNS and limits the optimization of the treatment effect. In addition, the stimulation parameters of existing devices are often relatively fixed and lack personalized treatment plans. Each patient's condition and physical condition are unique, and fixed stimulation parameters may not meet the needs of all patients, thus affecting the treatment effect. The present invention specifically provides a technical solution to the above-mentioned problems. The technical solution, working principle and technical effects of the present invention are described in detail below in conjunction with specific embodiments.

[0096] Reference Figure 1 , Figure 2As shown, the present invention describes a non-invasive closed-loop ear vagus nerve stimulator for improving stroke, which is a device that stimulates the vagus nerve through the ear skin to regulate brain function. The device adopts a non-invasive design, does not require surgical implantation of electrodes, is easy to operate, and patients can use it at home.

[0097] The device has a built-in closed-loop control system that can automatically adjust stimulation parameters based on the patient's real-time physiological feedback to ensure maximum treatment effect.

[0098] In order to further improve the rehabilitation effect of stroke patients, this embodiment introduces in detail an intelligent non-invasive closed-loop auricular vagus nerve stimulation system that integrates precise electrical stimulation electrodes 1, real-time monitoring and data fusion, closed-loop feedback adjustment, remote monitoring guidance, and user-friendly interactive functions. The system provides patients with personalized, efficient and safe treatment plans through scientifically set initial stimulation parameters, real-time monitoring of the patient's physiological state, intelligent adjustment of treatment strategies, and combined with telemedicine support.

[0099] The electrical stimulation electrode 1 is made of conductive silicone material and is non-invasively attached to the patient's cymba concha area through medical-grade adhesive. The electrode is lightweight and ensures the patient's comfort when wearing it for a long time.

[0100] The host 2 is designed as a wearable earphone structure, with a built-in rechargeable lithium battery, which is convenient for patients to carry, and an external charging interface 4 is provided for charging the lithium battery. The host 2 has a built-in microprocessor, which is responsible for controlling the stimulation parameters (including current intensity, frequency and waveform) of the electrical stimulation electrode 1, and receiving and processing the physiological data transmitted by the multimodal monitoring unit.

[0101] The multimodal monitoring unit is integrated in the host 2, and includes a near-infrared brain function imaging monitoring module, a heart rate sensor, a blood pressure sensor, and a blood oxygen saturation sensor. These sensors are connected to the host 2 via wired or wireless means to monitor the patient's brain blood flow changes, heart rate, blood pressure, and blood oxygen saturation in real time.

[0102] The data fusion analysis unit adopts weighted average method or Kalman filtering algorithm to comprehensively analyze the multiple physiological parameters received and generate a comprehensive physiological assessment index (CPI) for evaluating the patient's physiological state and treatment effect.

[0103] The closed-loop feedback module automatically adjusts the stimulation parameters of the electrical stimulation electrode 1 based on the real-time monitored cerebral blood flow data and CPI to achieve closed-loop control. The module has a built-in machine learning or deep learning algorithm unit that can intelligently adjust the stimulation parameters and optimize the treatment effect based on historical treatment data and real-time physiological data.

[0104] The host 2 of the remote intelligent monitoring and guidance system has a built-in wireless communication module to establish a communication connection with the remote medical platform or doctor's workstation. The wireless communication module follows the medical data security protocol and encrypts and transmits the patient's physiological data, treatment data and equipment status. The remote medical platform or doctor's workstation can display the received data in real time and provide remote treatment plan adjustment suggestions.

[0105] The user interaction interface includes a touch screen display and physical buttons for displaying treatment parameters, device status, viewing treatment progress, and setting parameters. The touch screen display supports touch operation, which is convenient for patients or medical staff to use. The physical buttons include a power switch 3, a power status indicator 5, a working status indicator 6, and an emergency stop button, which provide feedback on the working status of the device and an emergency stop function.

[0106] Combined with the settings of the above modules, the settings, functions and effects of each module are introduced in detail in combination with the corresponding data and parameters:

[0107] 1. Initial Setup of Electrical Stimulation Electrodes

[0108] 1. Disease assessment and stimulation intensity calculation

[0109] Condition assessment: First, use the internationally accepted stroke functional assessment scale (such as NIHSS) to quantify the patient's condition and determine its severity S.

[0110] Stimulation intensity calculation: According to the result of score S, use formula I init =0.5+(S max -S min ) / 1.5*(SS min ) to calculate the initial stimulus intensity.

[0111] Among them, Smax and Smin represent the maximum and minimum values ​​of the scale score respectively, S is the patient's current score, and Iinit is the calculated initial stimulation intensity, which is set in the range of 0.5mA to 2mA to ensure the effectiveness of the treatment.

[0112] The use of the above formula ensures that the stimulation intensity is closely related to the patient's condition, and is neither too strong to cause discomfort nor too low to affect the treatment effect.

[0113] 2. Real-time monitoring and data fusion

[0114] 1. Monitoring equipment configuration

[0115] Near-infrared brain functional imaging: Using near-infrared brain functional imaging technology, the patient's cerebral blood flow changes are monitored in real time and the data is transmitted to the host in real time.

[0116] Physiological parameter monitoring: integrated heart rate, blood pressure, and blood oxygen saturation sensors. The heart rate sensor, blood pressure sensor, and blood oxygen saturation sensor simultaneously monitor the patient's other key physiological parameters to ensure comprehensive monitoring and evaluation of the patient's physiological status.

[0117] 2. Data fusion analysis

[0118] Algorithm application: Use weighted average method or Kalman filter algorithm to integrate and analyze the collected multi-source data to generate a comprehensive physiological index (CPI) to provide a decision-making basis for closed-loop feedback.

[0119] The data fusion analysis unit uses the following formula to comprehensively analyze the multiple physiological parameters received, and the calculation formula of the comprehensive physiological state index CPI is:

[0120] I=w1×HR+w2×BP+w3×SpO2

[0121] Among them, w1, w2, and w3 are weight coefficients of each physiological parameter, which are set according to clinical experience and the specific conditions of the patient.

[0122] 3. Closed-loop feedback and intelligent adjustment

[0123] 1. Closed-loop feedback mechanism

[0124] Real-time adjustment: based on CPI and target CPI target The deviation of n+1 =I n +α*(CPI target -CPI current ) Automatically calculate the stimulus intensity I at the next moment n+1 .

[0125] Among them, I n+1 is the adjusted stimulus intensity, I n is the current stimulation intensity, and α is the adjustment coefficient, which is set according to clinical experience.

[0126] Parameter optimization: In addition to the stimulation intensity, based on the adjustment results of the stimulation intensity, the system also automatically adjusts the stimulation frequency and waveform according to preset rules to achieve the best treatment effect and ensure the personalization and optimization of the treatment plan.

[0127] 2. Intelligent control

[0128] Microprocessor control: All adjusted stimulation parameters are controlled in real time by the microprocessor in the host computer to control the output of the electrical stimulation electrodes, ensuring accurate treatment.

[0129] 4. Remote Monitoring and Guidance

[0130] 1. Data Transmission and Security

[0131] Encrypted transmission: The wireless communication module encrypts and transmits the patient's physiological data, treatment data and equipment status to the telemedicine platform or doctor's workstation. The data transmission uses the data compression function Comp (original data) to compress the data and encrypts it through the encryption function Enc (original data, key) to ensure the security and efficiency of the data during transmission.

[0132] 2. Telemedicine support

[0133] Real-time monitoring: Doctors can view patients’ physiological data, treatment data, and equipment status in real time through the telemedicine platform.

[0134] Treatment plan adjustment: Based on remote monitoring data, the doctor uses the adjustment suggestion formula ΔP=f(I t ,I ta ,P t ), provide personalized treatment plan adjustment suggestions to ensure continuous optimization of treatment effects.

[0135] Among them, I t is the current stimulus intensity, I ta is the target stimulus intensity, P t For current treatment plan.

[0136] 5. User Interaction and Operation

[0137] 1.Interactive interface design

[0138] Touch screen display: Patients or medical staff can intuitively view treatment parameters, equipment status, treatment progress and other information through the touch screen display.

[0139] Parameter setting and viewing: Supports users to set parameters, view historical data and other operations through the touch screen, improving the convenience of use.

[0140] Physical button control: Physical buttons are provided as backup control methods for emergency stop and status feedback, ensuring that the device can still be safely controlled in emergency situations such as touch screen failure.

[0141] 2. Information interaction method

[0142] Wired / wireless connection: supports multiple ways to connect to the host microprocessor. The user interface can be connected to the microprocessor in the host via wired or wireless means to achieve real-time information interaction and remote control.

[0143] 6. Data Storage and Transmission

[0144] 1. Data recording and management

[0145] Data storage unit: records all data during the patient's treatment process in detail to facilitate subsequent analysis and evaluation.

[0146] Data backup and recovery: Provide data backup and recovery functions to ensure data security and integrity.

[0147] 2. Efficient transmission

[0148] Compression and encryption: Use advanced data compression and encryption technologies to ensure that data is efficiently and securely transmitted to the telemedicine platform under limited bandwidth.

[0149] Specifically, the present invention is a non-invasive closed-loop ear vagus nerve stimulator for improving stroke. First, according to the severity score of the patient's condition, the initial stimulation intensity is calculated and set using a formula. The initial stimulation intensity is set to a value between 0.5mA and 2mA, which is specifically calculated according to formula I init =0.5+(S max -S min ) / 1.5*(SS min ) calculated.

[0150] Then, the near-infrared brain function imaging monitoring module monitors the patient's cerebral blood flow changes in real time and transmits the data to the host. At the same time, the heart rate sensor, blood pressure sensor and blood oxygen saturation sensor also monitor the patient's other physiological parameters in real time and send the data to the host. The data fusion analysis unit uses the weighted average method or Kalman filter algorithm to comprehensively analyze the received data and generate CPI.

[0151] When working, the closed-loop feedback module uses the stimulation intensity adjustment formula I according to the real-time monitored cerebral blood flow data and CPI. n+1 =I n +α*(CPI target -CPI current ) automatically calculates and adjusts the stimulation intensity of the electrical stimulation electrodes.

[0152] At the same time, according to the preset rules and stimulation intensity adjustment results, the stimulation frequency and waveform are automatically adjusted. The adjusted stimulation parameters are used to control the output of the electrical stimulation electrodes in real time through the microprocessor in the host.

[0153] When remote monitoring and guidance is needed, the patient's physiological data, treatment data and device status are encrypted and transmitted to the telemedicine platform or doctor's workstation through the wireless communication module. The doctor can view the patient's data in real time through the telemedicine platform and adjust the recommended formula ΔP=f(I t ,I ta ,P t ) Provide recommendations for adjustments to the remote treatment plan.

[0154] Doctors can adjust treatment plans based on patients' real-time data and historical treatment data to ensure optimal treatment outcomes.

[0155] In addition, the device has a user interaction and operation interface. Patients or medical staff can view treatment parameters, device status, treatment progress and other information through the touch screen display, and perform operations such as parameter setting and data viewing. Physical buttons provide feedback on the device's working status and emergency stop function to ensure safety. At the same time, the user interaction interface also supports connection with the microprocessor in the host through wired or wireless means to achieve real-time information interaction.

[0156] The device has both data storage and transmission functions. The data storage unit records the patient's treatment data and effects, which is convenient for doctors to conduct remote monitoring and evaluation. The wireless communication module uses the data compression function Comp (original data) to compress the data and efficiently transmit the data under limited bandwidth. At the same time, the encryption function Enc (original data, key) is used to encrypt the data for transmission to ensure the security of data transmission.

[0157] VII. Clinical Data Presentation

[0158] like Figure 3 , Figure 4 , Figure 5 As shown in the figure, in a clinical study on stroke patients, we used this non-invasive closed-loop ear vagus nerve stimulator for treatment. A total of 50 stroke patients were included in the study and randomly divided into a treatment group and a control group, with 25 people in each group. Patients in the treatment group received stimulation treatment for 4 weeks, once a day, 30 minutes each time. The control group received conventional treatment.

[0159] After the treatment, we evaluated the motor function, cognitive function and quality of life of the two groups of patients. The results showed that the motor function score (FMA) of the treatment group was improved by 20% (P<0.05), the cognitive function score (MMSE) was improved by 15% (P<0.05), and the quality of life score (SF-36) was improved by 18% (P<0.05) compared with the control group. In addition, no serious adverse reactions occurred in the treatment group during the treatment.

[0160] 8. Conclusion

[0161] This non-invasive closed-loop ear vagus nerve stimulator can effectively improve the motor function, cognitive function and quality of life of stroke patients by precisely stimulating the ear vagus nerve. It is highly safe and worthy of clinical application. In the future, we will further optimize the stimulation parameters and treatment methods in order to achieve better treatment effects.

[0162] In summary, the non-invasive closed-loop auricular vagus nerve stimulation system described in this embodiment provides an efficient, safe, and personalized rehabilitation treatment plan for stroke patients through precise electrical stimulation control, real-time physiological monitoring and data analysis, intelligent closed-loop feedback adjustment, convenient telemedicine support, and user-friendly interactive design. The application of this system will greatly improve the rehabilitation effect of stroke patients, reduce the medical burden, and improve the quality of life.

[0163] In combination with the above description, in order to more clearly illustrate the technical solution of the present invention, the working principle of the present invention is described in detail as follows:

[0164] 1. Initialization and self-test

[0165] Device startup: When the user presses the power switch of the device, the system starts immediately and enters the initialization phase. During this phase, the device will perform a series of preset parameter settings to ensure that all functional modules are in standby mode.

[0166] Comprehensive self-test: Next, the device will perform a comprehensive self-test procedure. This includes checking whether the electrode connection is firm, whether the current output is stable, whether the sensor is working properly, etc. After the self-test passes, the device will emit a prompt sound or light up the indicator light, indicating that it is ready for the next step.

[0167] 2. Real-time monitoring and data fusion

[0168] Cerebral blood flow monitoring: The near-infrared brain function imaging monitoring module starts working, using advanced near-infrared spectroscopy technology to monitor the dynamic changes of the patient's cerebral blood flow in real time. These data are accurately collected and transmitted to the host for subsequent processing.

[0169] Multi-physiological parameter monitoring: At the same time, the heart rate sensor, blood pressure sensor and blood oxygen saturation sensor are also started synchronously to monitor the patient's heart rate, blood pressure, blood oxygen saturation and other key physiological parameters. These data are also sent to the host to provide strong support for comprehensive evaluation.

[0170] Data fusion analysis: Inside the host, the data fusion analysis unit receives and integrates data from various sensors. Through advanced algorithm processing, these data are fused into a comprehensive physiological assessment index (CPI), which can fully reflect the patient's physiological state and treatment effect.

[0171] 3. Closed-loop feedback and intelligent adjustment

[0172] Closed-loop feedback mechanism: The closed-loop feedback module uses a built-in intelligent algorithm to quickly analyze the real-time monitored cerebral blood flow data and the comprehensive physiological assessment index (CPI). The algorithm automatically calculates the best electrical stimulation parameter adjustment plan based on the patient's real-time physiological state and treatment needs.

[0173] Intelligent parameter adjustment: The adjusted stimulation parameters (such as current intensity, frequency, pulse width, etc.) are instantly sent to the microprocessor in the host. The microprocessor accurately controls the output of the electrical stimulation electrodes based on these parameters to ensure that the treatment process always remains in the best state. This closed-loop control mechanism can significantly improve the accuracy and effectiveness of treatment.

[0174] 4. Remote Monitoring and Guidance

[0175] Data encryption transmission: The wireless communication module encrypts the patient's physiological data, treatment data, device status and other information, and then securely transmits them to the telemedicine platform or doctor's workstation via the wireless network. This ensures the privacy and security of the patient's data.

[0176] Remote treatment guidance: Doctors can view the patient's data and treatment progress in real time through the telemedicine platform. Based on these data and the treatment plan adjustment suggestion formula ΔP=f(It,Ita,Pt) (where It represents the current treatment time, Ita represents the accumulated treatment time, and Pt represents the patient's current physiological state), doctors can provide targeted treatment plan adjustment suggestions in a timely manner. This remote monitoring and guidance mechanism not only improves the flexibility of treatment, but also strengthens communication and collaboration between doctors and patients, bringing patients a more convenient and efficient treatment experience.

[0177] The present invention also records a method for using a non-invasive closed-loop ear vagus nerve stimulator for improving stroke, and the specific method of use is as follows:

[0178] Patients whose recovery progress is slow or stagnant after several months of cerebral hemorrhage or cerebral infarction are selected. Patients need to be evaluated by doctors to confirm that they have no other serious complications and are suitable for vagus nerve stimulation treatment.

[0179] S1. Preparation

[0180] S101. Electrode placement: First, attach the electrode of the stimulator to the vagus nerve distribution area of ​​the patient's hymena concha, usually below the auricle. This area is densely populated with vagus nerve branches, which can ensure that the electrical stimulation signal is effectively transmitted to the vagus nerve. When placing the electrode, ensure that the electrode is in close contact with the skin and avoid any bubbles or gaps to ensure the stability and safety of current conduction. Using conductive gel or patch can further enhance the fit of the electrode to the skin.

[0181] S102, Personalized parameter setting: According to the specific severity of the patient's condition, the initial current intensity is calculated and set using a pre-set formula. This process needs to comprehensively consider factors such as the patient's age, gender, course of disease, stroke type, and degree of functional impairment to ensure the personalization and accuracy of the treatment plan. In addition, the initial parameters can be fine-tuned by referring to historical treatment data or the average response of similar patients.

[0182] S2. Start the device

[0183] S201, equipment initialization and self-test: After the equipment is turned on by the power switch on the host, the system will automatically perform the initialization and self-test procedures. This process includes checking the electrode connection status, current output stability, wireless communication module connection status, etc., to ensure that the equipment is in the best working condition.

[0184] S202. Treatment mode selection: Select the appropriate treatment mode according to the doctor's treatment plan or the patient's specific needs. For example, for acute stroke patients, a high-intensity stimulation mode can be selected to promote neurological recovery; while for chronic patients, a mild continuous stimulation mode may be preferred to consolidate the treatment effect.

[0185] S3. Real-time monitoring and adjustment

[0186] S301, Near-infrared brain function imaging monitoring: Using advanced near-infrared brain function imaging monitoring module, real-time monitoring of the patient's brain blood flow. This module can non-invasively reflect the changes in brain neural activity and provide a scientific basis for the adjustment of treatment parameters.

[0187] S302, Automatic parameter optimization: The intelligent algorithm built into the host will automatically adjust the stimulation parameters (such as current intensity, frequency, pulse width, etc.) of the electrical stimulation electrodes according to the real-time monitored data. This process is a closed loop, which means that the system will dynamically optimize the treatment effect according to the patient's real-time response to ensure the safety and effectiveness of the treatment.

[0188] S4. Remote monitoring and guidance

[0189] S401, Data transmission and reception: The built-in wireless communication module of the device will send the patient's real-time data (including cerebral blood flow monitoring data, stimulation parameters, treatment effects, etc.) to the telemedicine platform or doctor's workstation. This process ensures that the doctor can keep track of the patient's treatment status at any time, find problems in time and make adjustments.

[0190] S402. Remote treatment plan adjustment: After receiving the patient data, the doctor will provide remote treatment plan adjustment suggestions based on professional knowledge and experience. These suggestions may involve fine-tuning of stimulation parameters, extension or shortening of treatment time, etc., aiming to ensure continuous optimization and personalization of the treatment process.

[0191] S5. End of treatment

[0192] S501. Turn off the device and remove the electrodes: After the treatment, first turn off the power switch of the device to stop the electrical stimulation output. Then, gently remove the electrical stimulation electrodes to avoid any discomfort or damage to the patient's skin.

[0193] S502. Equipment cleaning and disinfection: Thoroughly clean and disinfect the used equipment. This includes using medical alcohol or disinfectant to wipe the electrode surface, main unit housing, connecting wires and other parts to ensure the hygiene and safety of the equipment and prepare for the next use. At the same time, the integrity of the equipment must be checked. If damaged, it should be repaired or replaced in time.

[0194] 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 principles of the present invention should be included in the protection scope of the present invention.

[0195] In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the fact that ordinary technicians in the field can implement it; when the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

Claims

1. A non-invasive closed-loop ear vagus nerve stimulator for improving stroke, characterized in that: include: An electrical stimulation electrode, a host, and a closed-loop feedback module, wherein the electrical stimulation electrode is non-invasively placed in the cymba concha area of ​​the patient to stimulate the vagus nerve of the ear; A host computer with a built-in microprocessor for controlling the stimulation parameters of the electrical stimulation electrodes; The host is also equipped with a multi-modal monitoring unit and a data fusion analysis unit to conduct comprehensive analysis of the multiple physiological parameters received to monitor and evaluate the patient's physiological state and treatment effect; The multimodal monitoring unit includes a real-time monitoring module for real-time monitoring of changes in the patient's cerebral blood flow; the real-time monitoring module adopts a near-infrared brain function imaging monitoring module, which is integrated into the host or connected to the host as a split module for communication; The data fusion analysis unit in the host computer uses weighted average method or Kalman filter algorithm to fuse multiple physiological parameters and generate a comprehensive physiological assessment index; The closed-loop feedback module is based on the cerebral blood flow data monitored by the real-time monitoring module, and automatically adjusts the stimulation parameters of the electrical stimulation electrodes according to the real-time monitored cerebral blood flow conditions, so as to optimize the treatment effect and realize closed-loop control.

2. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 1, characterized in that: The real-time monitoring module is also integrated with a heart rate sensor, a blood pressure sensor, and a blood oxygen saturation sensor, which are respectively used to detect and monitor the patient's heart rate HR, blood pressure BP, and blood oxygen saturation SpO2; each sensor is connected to the host via a wired or wireless method to transmit the monitoring data to the host in real time; The real-time monitoring module is electrically connected to the host and transmits the real-time monitored cerebral blood flow data to the host for analysis and processing.

3. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 1, characterized in that: The data fusion analysis unit uses the following formula to perform comprehensive analysis on the received multiple physiological parameters, and the calculation formula of the comprehensive physiological state index CPI is: CPI=w1×HR+w2×BP+w3×SpO2 Among them, w1, w2, and w3 are weight coefficients of each physiological parameter, which are set according to clinical experience and the specific conditions of the patient.

4. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to any one of claim 1, characterized in that: The closed-loop feedback module is electrically connected to the microprocessor in the host computer via wired or wireless means; The host's microprocessor automatically adjusts the parameters of electrical stimulation, including the intensity and frequency of stimulation, through a built-in algorithm based on the real-time cerebral blood flow data provided by the near-infrared brain function imaging monitoring module. The closed-loop feedback module has a built-in machine learning or deep learning algorithm unit; The algorithm unit automatically calculates and adjusts the stimulation parameters of the electrical stimulation electrodes using the following formulas based on the real-time physiological data received by the host and the historical treatment data stored: Stimulus intensity adjustment formula: I n+1 =I n +α×(CPI target -CPI current ) Among them, I n+1 is the adjusted stimulus intensity, I n is the current stimulus intensity, α is the learning rate (0<α<1), CPI target The target comprehensive physiological state index, CPI current It is the current comprehensive physiological status index; The algorithm unit automatically calculates and adjusts the stimulation parameters of the electrical stimulation electrode using the above formula based on the real-time physiological data received by the host and the stored historical treatment data. The stimulation parameters include current intensity, frequency, and waveform. The output of the electrical stimulation electrode is controlled in real time by the microprocessor in the host. The frequency F and waveform W are adjusted automatically based on preset rules and stimulation intensity adjustment results. The adjusted stimulation parameters are used to control the output of the electrical stimulation electrodes in real time through the microprocessor in the host.

5. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 1, characterized in that: The initial stimulation intensity of the electrical stimulation electrode is set to 0.5 mA to 2 mA, and the initial stimulation intensity (mA) is set specifically according to the following formula: I init =0.5+S max -S min 1.5×(S-S min ) Among them, S is the severity score of the patient's condition, S min and S max are the minimum and maximum values ​​of the disease severity score, respectively; When working, based on the feedback data from the real-time monitoring module, the algorithm unit in the host automatically calculates and adjusts the stimulation intensity using the stimulation intensity adjustment formula, and the adjustment amplitude does not exceed 0.5mA each time; The electrical stimulation electrode automatically and gradually increases the intensity of electrical stimulation according to the feedback from the near-infrared brain function imaging monitoring module until a preset therapeutic effect or a therapeutic effect determined according to real-time monitoring data is achieved.

6. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 1, characterized in that: It also includes a remote intelligent monitoring and guidance system. The host has a built-in wireless communication module to establish a communication connection with a remote medical platform or a doctor's workstation; The wireless communication module complies with the medical data security protocol and encrypts and transmits the patient's physiological data, treatment data and device status to the telemedicine platform or doctor's workstation; the wireless communication module built into the host uses the following formula for data encryption transmission: text encrypted data = Enc (original data, key) Among them, Enc is the encryption function, the original data includes the patient's physiological data, treatment data and device status, and the key is the preset encryption key to ensure the security of data transmission; The telemedicine platform or doctor workstation can display the received data in real time and provide remote treatment plan adjustment suggestions based on the following formula; Among them, the recommended formula for adjusting the treatment plan is: ΔP=f(I t ,I ta ,P t ) Where ΔP is the adjustment amount of the treatment plan, f is a function set according to clinical experience and the specific situation of the patient, P t For current treatment plan.

7. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 1, characterized in that: The host also includes a user interaction interface, which includes a touch screen display and physical buttons; The touch screen display is used to display treatment parameters, device status, check treatment progress, and receive feedback on the working status of the device, and supports patients or medical staff to set parameters and view data through touch operations; The physical buttons include a power switch, a power status indicator light, a working status indicator light, and an emergency stop button, which are used to provide working status feedback or adjust the working status of the device; The user interaction interface is connected to the microprocessor in the host computer via wired or wireless means to achieve real-time interaction of information; The host further includes a wireless communication module, a data storage unit and a transmission module, wherein the data storage unit and the transmission module are used to record the patient's treatment data and effects and facilitate remote monitoring and evaluation by doctors; The wireless communication module is used to communicate with a remote medical device or a doctor's workstation to remotely monitor the patient's treatment progress and adjust stimulation parameters; The data storage unit is connected to the wireless communication module through the microprocessor in the host to realize remote transmission of data. Specifically, the following formula is used for data compression and transmission: text compressed data = Comp (original data) Comp is a data compression function, which ensures efficient data transmission under limited bandwidth.

8. The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 1, characterized in that: The electrical stimulation electrodes are made of conductive silicone material and are non-invasively adhered to the patient's cymba concha area through medical-grade adhesive; the host is configured as a wearable headphone structure with a built-in rechargeable lithium battery; the electrical stimulation electrodes are connected to the host through low-impedance, highly flexible wires to ensure the stability of signal transmission and the comfort of the patient.

9. A method for using a non-invasive closed-loop ear vagus nerve stimulator for improving stroke, characterized in that: The non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to any one of claims 1 to 8 is used, and the specific method of use is as follows: S1: Place the electrical stimulation electrode on the patient's cymba concha area, ensuring that the electrical stimulation electrode is in close contact with the skin; S2: Start the device through the power switch on the host, and the system automatically initializes, including parameter setting and device self-test; S3: Use the near-infrared brain function imaging module to monitor the cerebral blood flow in real time, and transmit the detected data to the host microprocessor in real time; S4: Based on the real-time monitored cerebral blood flow data, the host automatically adjusts the current intensity and / or frequency of the electrical stimulation electrodes according to the preset algorithm, and then dynamically adjusts the stimulation parameters to optimize the treatment effect.

10. The method for using the non-invasive closed-loop ear vagus nerve stimulator for improving stroke according to claim 9, characterized in that: Before starting the device, set the initial current intensity between 0.5mA and 2mA, and gradually adjust it according to the patient's tolerance and treatment progress; The host provides visual feedback and displays the working status and treatment effect of the device through a working display light, so that patients and doctors can understand the treatment progress in a timely manner.

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