In-ear non-invasive vagus nerve stimulator

Abstract

The invention discloses an in-ear non-invasive vagus nerve stimulator, and relates to the field of vagus nerve stimulators, and the in-ear non-invasive vagus nerve stimulator comprises an in-ear stimulating electrode, an electrocardiogram monitoring module, a pulse generator, a microcontroller and a man-machine interaction module. The microcontroller is used for controlling the pulse generator to generate electrical stimulation pulses with set stimulation intensity and set stimulation frequency according to the current stimulation parameters; the in-ear stimulation electrode is used for transmitting the electrical stimulation pulse to the vagus nerve of a user; the electrocardiogram monitoring module is used for monitoring electrocardiogram data of a user and calculating a heart rate value of the user according to the electrocardiogram data; the man-machine interaction module is used for a user to set initial stimulation parameters and adjust current stimulation parameters; the microcontroller is further used for controlling the man-machine interaction module to display the heart rate value and the current stimulation parameters in real time. The atrial fibrillation postoperative recurrence rate can be safely and effectively reduced with low cost.

Description

Technical Field

[0001] The present application relates to the field of vagus nerve stimulators, and in particular to an in-ear non-invasive vagus nerve stimulator. Background Art

[0002] Atrial fibrillation (AF) is a common persistent arrhythmia that has a serious impact on the patient's quality of life and increases the risk of complications such as heart failure and stroke. Radiofrequency ablation is an important means of treating atrial fibrillation. Although it has the advantages of being minimally invasive, painless, and quick to recover, the recurrence rate of atrial fibrillation after surgery is high, which brings a heavy burden to patients and the medical system. How to solve the problem of high recurrence rate is an urgent problem that clinicians need to solve.

[0003] Vagus nerve stimulation (VNS) has a history of nearly 100 years in the treatment of cardiovascular diseases. It was originally used to prevent and treat malignant ventricular arrhythmias after myocardial infarction. With the deepening of research, VNS has been found to have a protective effect on myocardial ischemia-reperfusion injury, heart failure and other diseases. In recent years, studies have revealed that VNS may play a protective role in cardiovascular diseases by reducing inflammatory response, oxidative stress, improving endothelial cell function, and inhibiting sympathetic nerve activation. However, related VNS treatment requires surgical implantation of a neck stimulator, which is not only expensive, but also may bring risks such as bleeding, infection, and nerve damage, limiting its widespread application. In addition, VNS treatment may be accompanied by adverse reactions such as coughing, hoarseness, and dysphagia, which affect patient compliance. Therefore, how to design a low-cost, safe, and effective vagus nerve stimulator to reduce the recurrence rate of atrial fibrillation after surgery has become an urgent problem to be solved. Summary of the invention

[0004] The purpose of this application is to provide an in-ear non-invasive vagus nerve stimulator that can reduce the recurrence rate of atrial fibrillation after surgery in a low-cost, safe and effective manner.

[0005] To achieve the above objectives, this application provides the following solutions:

[0006] The present application provides an in-ear non-invasive vagus nerve stimulator, comprising: an in-ear stimulation electrode, an electrocardiogram monitoring module, a pulse generator, a microcontroller and a human-computer interaction module; the electrocardiogram monitoring module, the pulse generator and the human-computer interaction module are all connected to the microcontroller; the in-ear stimulation electrode is connected to the pulse generator;

[0007] The microcontroller is used to control the pulse generator to generate electrical stimulation pulses with set stimulation intensity and set stimulation frequency according to current stimulation parameters; the in-ear stimulation electrode is used to transmit the electrical stimulation pulses to the user's vagus nerve; the electrocardiogram monitoring module is used to monitor the user's electrocardiogram data and calculate the user's heart rate value based on the electrocardiogram data; the human-computer interaction module is used for the user to set the initial stimulation parameters and adjust the current stimulation parameters; the microcontroller is also used to control the human-computer interaction module to display the heart rate value and current stimulation parameters in real time.

[0008] According to the specific embodiments provided in this application, this application has the following technical effects:

[0009] The present application provides an in-ear non-invasive vagus nerve stimulator, which transmits electrical stimulation pulses to the user's vagus nerve through in-ear stimulation electrodes to reduce the recurrence rate of atrial fibrillation after surgery. There is no need to implant a neck stimulator, which is low-cost and safe, and helps promote the popularization of atrial fibrillation treatment. The electrocardiogram monitoring module monitors the changes in electrocardiogram signals in real time, which can detect abnormal heart rate in time and reduce treatment risks. The real-time display of heart rate through the human-computer interaction module allows users or doctors to quickly and accurately adjust stimulation parameters to improve treatment effects. The non-invasive design and comfortable wearing experience improve user compliance and continuity of treatment. The present application reduces the recurrence rate of atrial fibrillation after surgery in a low-cost, safe and effective manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0011] Figure 1 A schematic diagram of the structure of an in-ear non-invasive vagus nerve stimulator provided in one embodiment of the present application;

[0012] Figure 2 A more specific structural schematic diagram of an in-ear non-invasive vagus nerve stimulator provided in another embodiment of the present application;

[0013] Figure 3 A front view schematic diagram of an in-ear stimulation electrode provided in one embodiment of the present application;

[0014] Figure 4 A schematic diagram of the back side of an in-ear stimulation electrode provided in one embodiment of the present application;

[0015] Figure 5A schematic diagram of a wearing scenario of an in-ear stimulation electrode provided in an embodiment of the present application;

[0016] Figure 6 A diagram of a visual user interface provided for an embodiment of the present application. DETAILED DESCRIPTION

[0017] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0018] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, the present application is further described in detail below with reference to the accompanying drawings and specific implementation methods.

[0019] Currently, there are a variety of vagus nerve stimulation devices on the market, but most devices still have deficiencies in functionality and user experience. Related devices usually lack real-time electrocardiogram monitoring capabilities and cannot dynamically feedback the patient's heart rate changes. In addition, the adjustment of stimulation parameters is often difficult to display synchronously, and the lack of a visual interface makes it difficult for doctors to respond quickly and accurately when adjusting stimulation parameters. The lack of continuous pulse delivery function may also make patients feel uncomfortable during treatment, affecting the smooth progress of treatment. To overcome these limitations, researchers are exploring safer and more effective VNS applications, such as transcutaneous auricular vagus nerve stimulation (ta-VNS), which is a non-invasive and easy-to-operate treatment method that is expected to be regarded as a potential treatment strategy to reduce the recurrence rate after atrial fibrillation ablation.

[0020] In an exemplary embodiment, Figure 1 As shown, an in-ear non-invasive vagus nerve stimulator is provided, comprising: an in-ear stimulation electrode, an electrocardiogram monitoring module, a pulse generator, a microcontroller and a human-computer interaction module; the electrocardiogram monitoring module, the pulse generator and the human-computer interaction module are all connected to the microcontroller; the in-ear stimulation electrode is connected to the pulse generator.

[0021] The microcontroller is used to control the pulse generator to generate electrical stimulation pulses with set stimulation intensity and set stimulation frequency according to current stimulation parameters; the in-ear stimulation electrode is used to transmit the electrical stimulation pulses to the user's vagus nerve; the electrocardiogram monitoring module is used to monitor the user's electrocardiogram (ECG) data and calculate the user's heart rate value based on the ECG data; the human-computer interaction module is used for the user to set the initial stimulation parameters and adjust the current stimulation parameters; the microcontroller is also used to control the human-computer interaction module to display the heart rate value and current stimulation parameters in real time.

[0022] The embodiment of the present application is a novel transcutaneous auricular vagus nerve stimulator integrating multiple functions, which can reduce the recurrence rate of atrial fibrillation after surgery and improve the safety and effectiveness of treatment.

[0023] In another exemplary embodiment of the present application, see Figure 1 and Figure 2 The in-ear non-invasive vagus nerve stimulator also includes: a wireless communication module; the wireless communication module is connected to the microcontroller; the microcontroller is also used to send the heart rate value and the current stimulation parameters to the doctor APP through the wireless communication module, and the doctor realizes remote monitoring through the doctor APP.

[0024] Existing devices rarely deliver data directly to the doctor's APP, increasing the risk of delayed disease treatment and the occurrence of adverse events. This embodiment uses a wireless communication module to transmit treatment data to medical professionals, facilitating remote monitoring and medical consultation, and improving the safety of treatment.

[0025] In this embodiment, the wireless communication module may be Bluetooth.

[0026] In another exemplary embodiment of the present application, in terms of the user adjusting the current stimulation parameters, the human-computer interaction module is specifically used for the user to increase the stimulation intensity according to his or her own physical state (such as tolerance) to adjust the current stimulation parameters, and finally use 80% of the stimulation intensity that causes ear pain and / or heart rate slowdown in the patient as the final stimulation intensity. For example, if the user does not have ear pain and / or heart rate slowdown, the stimulation intensity can be gradually increased to achieve the best safety parameters, and the stimulation parameters can be better adjusted to ensure the treatment effect. Once the patient has ear pain and / or heart rate slowdown, the stimulation intensity is immediately stopped from being increased, and 80% of the stimulation intensity at this time is used as the final stimulation intensity.

[0027] The stimulation parameters are adjusted by pulse modulation, waveform modulation, frequency modulation and amplitude modulation of the in-ear stimulation electrodes. The stimulation parameters include stimulation intensity, stimulation frequency, stimulation width, stimulation duration and pulse waveform type.

[0028] In another exemplary embodiment of the present application, the in-ear non-invasive vagus nerve stimulator further includes: an early warning module; the early warning module is connected to the microcontroller; the microcontroller is also used to evaluate the user's heart rhythm state according to the heart rate value, and control the early warning module to send an alarm signal according to the heart rhythm state. Figure 2 , the early warning module can be a voice player.

[0029] In this embodiment, when the microcontroller evaluates the heart rhythm state of the user, specifically: the preset algorithm is used to evaluate the heart rhythm state of the user according to the heart rate value. Among them, the preset algorithms include the following:

[0030] 1) Filtering algorithm: used to remove noise and artifacts in ECG signals, such as baseline drift, myoelectric interference, and power line interference. Common filtering methods include bandpass filters, low-pass filters, and high-pass filters.

[0031] 2) R wave detection algorithm: used to identify the R wave in the ECG signal, which is an important sign of the heart cycle. Common R wave detection algorithms include: Pan-Tompkins algorithm and adaptive sliding window algorithm.

[0032] 3) Feature extraction algorithm: Extract useful features from ECG signals, such as heart rate, heart rate variability (HRV), QT interval, P wave, QRS complex and T wave. These features are crucial for the assessment of heart rhythm status.

[0033] 4) Arrhythmia classification algorithm: Use machine learning or deep learning methods to classify cardiac rhythm states, such as normal rhythm, supraventricular tachycardia, sinus bradycardia, atrioventricular block, atrial fibrillation, etc. These algorithms may include support vector machine (SVM), random forest, neural network, etc.

[0034] 5) Auto-Regressive Moving Average (ARMA) model: used to model and analyze ECG signals and extract signal features, such as heart rate and heart rate variability. The ARMA model can smooth and filter ECG signals and estimate the true value of the observed data.

[0035] 6) Wavelet transform: used for preprocessing of ECG signals, removing baseline drift and high-frequency noise, improving signal quality, and providing a clean signal for subsequent feature extraction and analysis.

[0036] 7) Heart rate and heart rate variability analysis: Evaluate the stability and variability of heart rate, which is very important for monitoring the health status of patients.

[0037] 8) Real-time monitoring and early warning algorithm: used to monitor the patient's heart rhythm status in real time and provide early warning when abnormalities are detected, which is crucial for timely medical intervention.

[0038] In another exemplary embodiment of the present application, see Figure 2 The electrocardiogram monitoring module includes: an electrocardiogram inductor, an electrocardiogram sensor, a signal amplifier, a signal filter, an analog converter and a heart rate calculation module connected in sequence.

[0039] The ECG sensor is used to sense the user, obtain the user's ECG signal, and convert the ECG signal into an electrical signal. Specifically, the in-ear non-invasive vagus nerve stimulator also includes: a touch button; the touch button is connected to the ECG sensor; the user can place the thumb on the touch button to generate an external physical signal of touch pressing, so that the ECG sensor can sense the user's ECG signal. The touch button is marked with a thumb placement, and two touch buttons can be set. After the user places both thumbs on the thumb placement of the corresponding touch button, the user's ECG signal can be obtained.

[0040] The ECG sensor is used to obtain the electrical signal. The ECG sensor further captures and converts the electrical signal sensed by the ECG sensor, and can provide more accurate ECG data. The signal amplifier is used to enhance the electrical signal. Since the electrical signal is very weak, the signal amplifier is used to enhance the signal for subsequent processing. The signal filter is used to remove noise and interference in the enhanced electrical signal to ensure the purity of the signal. The analog converter is used to convert the electrical signal after noise removal into a digital signal; the digital signal is used as the user's ECG data; the heart rate calculation module is used to calculate the user's heart rate value based on the ECG data. The digital signal is convenient for the microcontroller to perform subsequent processing.

[0041] In another exemplary embodiment of the present application, see Figure 3-Figure 5 The in-ear stimulation electrode includes: an electrode body and an ear hook; the ear hook is arranged on the electrode body; the electrode body is used to fit the user's ear canal; the ear hook is used to fix the electrode body. Figure 3 The front side of the in-ear stimulation electrode is shown. Figure 4 The back side of the in-ear stimulation electrode is shown. Figure 5 The wearing scenario of the in-ear stimulation electrodes is shown.

[0042] In this embodiment, the electrode body is the core part of the in-ear stimulation electrode, which includes electrodes and related electronic components. The design of the electrode body is to ensure that it fits the ear canal so as to effectively transmit stimulation. The ear hook is designed to fix the electrode body so that it is stable on the auricle to prevent it from falling off during exercise or daily activities. The shape and flexibility of the ear hook are the key to ergonomic design to ensure comfort and stability of wearing.

[0043] In this embodiment, the electrode body and the ear hook can also be fixed together by connecting components, and the connecting components can exemplarily include: buckles or screws, etc. The design of these connecting components needs to facilitate assembly and disassembly while ensuring the firmness of the connection.

[0044] The in-ear stimulation electrode of this embodiment is designed based on ergonomics, and the following aspects are mainly considered during the design: 1) Fit: The shape and size of the electrode body need to match the anatomical structure of the ear canal to ensure good contact between the electrode and the skin, thereby improving the effectiveness of stimulation transmission. 2) Comfort: The materials of the ear hook and the electrode body need to be soft and skin-friendly to reduce discomfort from long-term wear. 3) Stability: The design of the ear hook needs to take into account the shape and size of the auricle of different users to ensure that the electrode can remain stable during various activities. 4) Ease of use: The design of the connecting parts needs to be simple and intuitive so that users can easily install and remove the electrodes. 5) Concealment: The small size and lightweight design of the device help to improve concealment and reduce the embarrassment of users when using it in public places.

[0045] The ear-in stimulation electrode of this embodiment is designed in accordance with ergonomics, ensuring comfort when worn and effectiveness of stimulation transmission. The material of the electrode is selected taking biocompatibility into consideration to avoid irritation to the skin.

[0046] In another exemplary embodiment of the present application, the human-computer interaction module includes a display screen having a visual user interface to realize the human-computer interaction function. The display screen can display not only the heart rate value and the current stimulation parameters, but also the waveform of the electrocardiogram data.

[0047] In another exemplary embodiment of the present application, the in-ear non-invasive vagus nerve stimulator further includes: a power module; the power module is connected to the microcontroller. Figure 2 The power module includes: a lithium battery, a voltage stabilizing circuit and a USB interface connected in sequence; the USB interface is connected to the microcontroller. The power module provides the power required by the device to ensure the stability of the device during use.

[0048] In another exemplary embodiment of the present application, please refer to Figure 2The in-ear non-invasive vagus nerve stimulator also includes: a memory; the memory is connected to the microcontroller; the memory is used to store heart rate values, current stimulation parameters, electrocardiogram data, etc.

[0049] In another exemplary embodiment of the present application, the in-ear non-invasive vagus nerve stimulator further includes: a temperature detection module; the temperature detection module is connected to the microcontroller. The temperature detection module is used to detect the temperature of the in-ear stimulation electrode, the electrocardiogram monitoring module, the pulse generator, the microcontroller, the human-computer interaction module and the power module; the microcontroller is used to control the on and off of the power module according to the temperature, for example, when it is detected that the temperature of any component exceeds a set temperature threshold, the power module is controlled to cut off the power supply.

[0050] The temperature detection module in this embodiment may illustratively include multiple temperature sensors, such as thermistors, etc.

[0051] The present embodiment provides a temperature detection module, so that the in-ear non-invasive vagus nerve stimulator has safety mechanisms such as overheat protection and automatic power-off, ensuring that stimulation can be stopped immediately under abnormal circumstances.

[0052] In another exemplary embodiment of the present application, the entire implementation process of the in-ear non-invasive vagus nerve stimulator mainly includes the following steps.

[0053] (1) Device startup and initialization. When using the device, the user only needs to press the start button and the device will automatically perform self-test and initialization. The self-test process includes a functional check of all modules to ensure that components such as the ECG monitoring module, pulse generator, and microcontroller are in normal working condition. After initialization is completed, the device will enter the preparation state for heart rate monitoring and stimulation parameter setting.

[0054] (2) Real-time heart rate monitoring and analysis. After the device is started, the ECG monitoring module captures the patient's ECG signal in real time. The microcontroller analyzes the heart rate data through a preset algorithm to evaluate the heart rhythm status. If an abnormal heart rate is found (such as atrial fibrillation, atrial fibrillation with long RR intervals, atrioventricular block, significant sinus bradycardia, etc.), the system will issue an alarm to prompt the user to adjust the treatment plan in time to ensure the safety of treatment.

[0055] (3) Setting of the visual user interface. The user operates through the interface of the human-computer interaction module to set the stimulation parameters. The interface design is intuitive, and the user can easily view the real-time heart rate display and stimulation parameter feedback. The stimulation parameters include: stimulation intensity, stimulation frequency, stimulation width, stimulation duration and pulse waveform type. Among them, stimulation intensity: the range is 0-10mA, and the user can adjust it according to the patient's tolerance. Stimulation frequency: the adjustable range is 1-30Hz, and the user can choose according to treatment needs. Stimulation width: the adjustable range is 1-1000μs, and the user can choose according to treatment needs. Stimulation duration: can be set to 1-120 minutes to ensure treatment flexibility. Pulse waveform selection: square wave, sine wave, bidirectional wave, the user can choose according to treatment needs. Visual user interface such as Figure 6 shown.

[0056] (4) Stimulation parameter adjustment and pulse emission. After the user sets the stimulation parameters, the microcontroller will control the pulse generator to emit pulses of appropriate intensity and frequency according to these settings. Through the in-ear electrodes, these pulses will be effectively transmitted to the vagus nerve, promoting the regulation of the nerve.

[0057] (5) Setting of continuous pulse delivery mechanism. The device is designed to deliver pulses continuously for a long time according to preset programs or user input. Users can select continuous stimulation mode to ensure the continuity of treatment and maximize the treatment effect.

[0058] (6) Real-time monitoring and automatic feedback adjustment. During the treatment process, the device will continuously monitor the ECG changes. The microcontroller can automatically adjust the stimulation parameters based on real-time data to adapt to the patient's physiological state and ensure the optimization of the treatment effect.

[0059] (7) Setting of safety features and protection mechanisms. This embodiment has multiple safety features, including overheat protection and automatic power-off mechanism. When the device detects an abnormal situation, it can immediately stop stimulation to ensure the safety of the patient.

[0060] (8) End of treatment and data recording. After the user completes the treatment, the device will automatically save the treatment data, including electrocardiogram records, stimulation parameters, etc. These data will be used for subsequent analysis and evaluation to help doctors develop more effective treatment plans.

[0061] (9) Data transmission and remote monitoring. The device transmits treatment data to medical professionals in real time through a wireless communication module, facilitating remote monitoring and medical consultation. This function not only improves the safety of treatment, but also provides patients with more convenient medical services.

[0062] (10) Structural optimization and ergonomic design. The in-ear electrode design of the device takes ergonomics into full consideration to ensure wearing comfort and effectiveness of stimulation delivery. The small size and lightweight design of the device make it more convenient for patients to use, improving patient compliance and continuity of treatment.

[0063] The beneficial effects of the present application are described below by comparing it with the existing transcutaneous auricular vagus nerve stimulation device.

[0064] Existing transcutaneous auricular vagus nerve stimulation devices face the following main problems in clinical applications:

[0065] (1) Lack of real-time monitoring: Most devices cannot display electrocardiograms in real time, which results in doctors being unable to grasp the patient's heart rate changes in a timely manner during treatment, increasing treatment risks.

[0066] (2) Inconvenient adjustment of stimulation parameters: Existing equipment has deficiencies in the synchronous display of stimulation intensity and frequency, making it difficult to make reasonable adjustments based on the patient's condition. This undoubtedly increases the difficulty for doctors and patients to perform precise stimulation and limits the maximization of treatment effects.

[0067] (3) Poor user experience: Existing non-invasive stimulation devices mostly adopt an ear clip design, which may cause discomfort to patients if used for a long time, especially in treatment plans that require continuous stimulation. This design limits patient compliance and affects the continuity and effectiveness of treatment.

[0068] (4) Poor data transmission: Most devices are unable to directly present the results of real-time dynamic monitoring to doctors, resulting in doctors being unable to promptly understand the occurrence of arrhythmias in patients during home treatment, increasing the risk of timely diagnosis and treatment for patients and the occurrence of adverse events.

[0069] The in-ear non-invasive vagus nerve stimulator of the present application can realize real-time heart rate monitoring, visual operation interface, continuous pulse delivery and arrhythmia diagnosis, thereby improving the safety and effectiveness of treatment. It is mainly manifested in the following aspects:

[0070] (1) After the device is turned on, it performs self-test and initialization to ensure that all modules are ready for heart rate monitoring and stimulation parameter setting.

[0071] (2) The electrocardiogram monitoring module captures and analyzes heart rate data in real time, and the microcontroller evaluates the heart rhythm status according to the preset algorithm to ensure the safety of treatment.

[0072] (3) The stimulation intensity, frequency, and duration are set through the display interface, which provides real-time electrocardiogram display and stimulation parameter feedback, so that users can adjust the stimulation parameters based on the feedback.

[0073] (4) The microcontroller controls the pulse generator to emit pulses of appropriate intensity and frequency, which are transmitted to the vagus nerve through the in-ear electrodes.

[0074] (5) The device is designed to deliver pulses continuously for a long period of time according to a preset program or user input to ensure continuity of treatment.

[0075] (6) During treatment, the device continuously monitors ECG changes and automatically adjusts stimulation parameters to suit the patient's condition to ensure treatment effectiveness.

[0076] (7) The device has safety mechanisms such as overheat protection and automatic power off to ensure that stimulation can be stopped immediately under abnormal circumstances.

[0077] (8) After the user finishes the treatment, the device automatically saves the treatment data, including electrocardiogram records, stimulation parameters, etc., for subsequent analysis.

[0078] (9) The treatment data is transmitted to medical professionals through the wireless communication module to facilitate remote monitoring and medical consultation, avoiding delayed diagnosis and treatment of arrhythmias.

[0079] (10) The in-ear electrode design of the device takes ergonomics into consideration to ensure wearing comfort and effectiveness of stimulation delivery. The device’s small size and lightweight design also improve the convenience of use for patients.

[0080] It can be seen that this application significantly improves the safety, personalization and convenience of treatment by integrating real-time heart rate monitoring, visual operation interface, continuous pulse delivery and other functions. Compared with traditional equipment, this application can monitor electrocardiogram changes in real time, detect heart rate abnormalities in time, and reduce treatment risks; the visual interface enables doctors to quickly and accurately adjust stimulation parameters to improve treatment effects; the non-invasive design and comfortable wearing experience improve patient compliance and continuity of treatment. In addition, the low-cost nature of the device is expected to promote the popularization of atrial fibrillation treatment.

[0081] The technical features of the above embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0082] This article uses specific examples to illustrate the principles and implementation methods of this application. The description of the above embodiments is only used to help understand the method and core ideas of this application. At the same time, for those skilled in the art, according to the ideas of this application, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting this application.

Claims

1. An in-ear non-invasive vagus nerve stimulator, characterized in that: The in-ear non-invasive vagus nerve stimulator comprises: an in-ear stimulation electrode, an electrocardiogram monitoring module, a pulse generator, a microcontroller and a human-computer interaction module; the electrocardiogram monitoring module, the pulse generator and the human-computer interaction module are all connected to the microcontroller; the in-ear stimulation electrode is connected to the pulse generator; The microcontroller is used to control the pulse generator to generate electrical stimulation pulses with set stimulation intensity and set stimulation frequency according to current stimulation parameters; the in-ear stimulation electrode is used to transmit the electrical stimulation pulses to the user's vagus nerve; the electrocardiogram monitoring module is used to monitor the user's electrocardiogram data and calculate the user's heart rate value based on the electrocardiogram data; the human-computer interaction module is used for the user to set the initial stimulation parameters and adjust the current stimulation parameters; the microcontroller is also used to control the human-computer interaction module to display the heart rate value and current stimulation parameters in real time.

2. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: The in-ear non-invasive vagus nerve stimulator also includes: a wireless communication module; the wireless communication module is connected to the microcontroller; the microcontroller is also used to send the heart rate value and current stimulation parameters to the doctor APP through the wireless communication module.

3. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: In terms of the user adjusting the current stimulation parameters, the human-computer interaction module is specifically used for the user to increase the stimulation intensity according to his or her own physical condition to adjust the current stimulation parameters.

4. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: The in-ear non-invasive vagus nerve stimulator also includes: an early warning module; the early warning module is connected to the microcontroller; the microcontroller is also used to evaluate the user's heart rhythm state according to the heart rate value, and control the early warning module to send an alarm signal according to the heart rhythm state.

5. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: The electrocardiogram monitoring module comprises: an electrocardiogram inductor, an electrocardiogram sensor, a signal amplifier, a signal filter, an analog converter and a heart rate calculation module connected in sequence; The ECG sensor is used to sense the ECG signal of the user and convert the ECG signal into an electrical signal; the ECG sensor is used to obtain the electrical signal; the signal amplifier is used to enhance the electrical signal; the signal filter is used to remove noise from the enhanced electrical signal; the analog converter is used to convert the electrical signal after noise removal into a digital signal; the digital signal is used as the user's ECG data; the heart rate calculation module is used to calculate the user's heart rate value based on the ECG data.

6. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: The in-ear stimulation electrode comprises: an electrode body and an ear hook; the ear hook is arranged on the electrode body; the electrode body is used to fit the ear canal of the user; and the ear hook is used to fix the electrode body.

7. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: The in-ear non-invasive vagus nerve stimulator also includes: a power module; the power module is connected to the microcontroller.

8. The in-ear non-invasive vagus nerve stimulator according to claim 7, characterized in that: The in-ear non-invasive vagus nerve stimulator further includes: a temperature detection module; the temperature detection module is connected to the microcontroller; The temperature detection module is used to detect the temperature of the in-ear stimulation electrode, the electrocardiogram monitoring module, the pulse generator, the microcontroller, the human-computer interaction module and the power module; the microcontroller is used to control the on and off of the power module according to the temperature.

9. The in-ear non-invasive vagus nerve stimulator according to claim 7, characterized in that: The power module comprises: a lithium battery, a voltage stabilizing circuit and a USB interface which are connected in sequence; the USB interface is connected to the microcontroller.

10. The in-ear non-invasive vagus nerve stimulator according to claim 1, characterized in that: The stimulation parameters include: stimulation intensity, stimulation frequency, stimulation width, stimulation duration and pulse waveform type.

Images