Nerve stimulation system and stimulation method

Abstract

The invention discloses a nerve stimulation system and a nerve stimulation method, and belongs to the field of nerve stimulation. The earphone is fixed on the ear of the patient; the earplug is fixedly arranged on the earphone so as to be inserted into the ear canal of the patient; the nerve stimulation electrode is arranged on the earplug and emits stimulation current; the electrocardiogram detection electrode is arranged on the earphone; the host is connected with the nerve stimulation electrode and the electrocardiogram detection electrode; the two earphones are connected through a cross beam to correspond to the left ear and the right ear of a patient. The nerve stimulation electrode comprises a positive electrode contact and a negative electrode contact, and electrical stimulation of the ear vagus nerve is achieved through current flowing between the positive electrode contact and the negative electrode contact. The host is also provided with a control module and an intelligent terminal. The control module is electrically connected with the nerve stimulation electrode; the earphone is also provided with an adjusting part for adjusting the position of the earplug in the ear canal. The earphone is also provided with earmuffs used for completely wrapping ears. The nerve stimulation system and the nerve stimulation method have the beneficial effect that the nerve stimulation system and the nerve stimulation method are comfortable to wear.

Description

Technical Field

[0001] The present application relates to the field of neural stimulation, and in particular, to a neural stimulation system. Background Art

[0002] The vagus nerve is the most widely distributed and longest of the twelve pairs of cranial nerves. It is a mixed nerve composed of about 20% efferent fibers and about 80% afferent fibers. It controls and dominates the functions of multiple organs, glands, involuntary muscles, etc. in the human body. Vagus nerve stimulation (VNS) generally refers to the technology of stimulating the vagus nerve. As the fastest-growing neuroregulatory technology in the past 20 years, it has been approved by the FDA for the clinical treatment of drug-resistant epilepsy, severe depression, and obesity. The auricular branch of the vagus nerve projects sensations from the ear to the nucleus tractus solitarius. Its terminal nerve located in the auricle is relatively superficial and is the only vagus nerve target that can be regulated by electrical stimulation. Transcutaneous auricular vagus vervestimulation (taVNS) is a non-invasive neuroregulatory technology with the advantages of being non-invasive and having higher safety. Currently, taVNS products and ear vagus nerve stimulation technologies are mostly open-loop stimulation modes, that is, the stimulation amplitude (current, voltage), stimulation frequency, stimulation pulse width, stimulation time and other stimulation parameters of the stimulator are set based on existing experience. It is impossible to observe the stimulation effect in real time, and it is even more impossible to determine personalized stimulation parameters based on the subject's physiological response. Especially when wearing the stimulation device for a long time, it will make the patient feel uncomfortable. Therefore, there is a need for a neural stimulation system that can improve wearing comfort. Summary of the invention

[0003] The content of this application is used to introduce concepts in a brief form, which will be described in detail in the detailed implementation section below. The content of this application is not intended to identify the key features or essential features of the technical solution claimed for protection, nor is it intended to limit the scope of the technical solution claimed for protection.

[0004] In order to solve the technical problems mentioned in the above background technology section, some embodiments of the present application provide a neural stimulation system, including: Earphones, fixed on the patient's ears; An earplug, fixedly mounted on the earphone and inserted into the patient's ear canal; A nerve stimulation electrode, which is placed on the earplug and emits a stimulation current; Electrocardiogram detection electrodes are provided on the earphones; A host computer, connected with nerve stimulation electrodes and electrocardiogram detection electrodes; Among them, two earphones are provided and connected by a crossbeam to correspond to the left and right ears of the patient; the nerve stimulation electrode includes two electrode contacts, a positive electrode and a negative electrode, and the electrical stimulation of the ear vagus nerve is achieved by the flow of current between the positive and negative electrodes; a control module and an intelligent terminal are also provided on the host; the control module is electrically connected to the nerve stimulation electrode; an adjustment component is also provided on the earphone to adjust the position of the earplug in the ear canal; and an earmuff is also provided on the earphone for completely covering the ear; During use, the earphones are worn on the patient's ears, and the position of the earplugs is adjusted by adjusting the components so that the earplugs can be completely inserted into the ear canals; the patient's ECG condition is detected by ECG detection electrodes; and the earmuffs are provided to wrap the entire ears for improved comfort.

[0005] Furthermore, the adjusting component comprises: Universal ball, rotatably set on the headset; An adjusting rod is fixedly arranged on the universal ball; A moving rod is movably arranged in the universal ball and fixedly connected to the earplug; A buffer cavity is formed inside the adjusting rod to guide the movement of the moving rod; the moving rod is connected to the inner wall of the buffer cavity through an elastic member; an adjusting block is arranged at one end of the buffer cavity away from the moving rod; and there is normal pressure gas between the adjusting block and the moving rod.

[0006] Furthermore, the surface of the earphone close to the ear is concave to form a groove corresponding to the universal ball; The universal ball is embedded in the groove so that the universal ball can rotate in the groove in a universal direction; The inner wall portion of the groove penetrates in a direction away from the ear portion to form an adjustment groove; The diameter of the adjusting slot is larger than the diameter of the adjusting rod.

[0007] Furthermore, the adjustment block is connected to the inner wall of the buffer cavity via threads; A piston block is fixedly arranged at the end of the regulating block; The adjusting block is rotated to realize the movement of the piston block in the buffer chamber.

[0008] Further, the earmuff is constructed in a ring shape; The earmuff comprises a leather wrapping portion and a filling portion in the wrapping portion; Wherein, a constant temperature component is fixedly arranged in the filling part to adjust the surface temperature of the earmuff.

[0009] Further, the thermostatic component comprises: A constant temperature plate, fixedly arranged in the filling part; The semiconductor refrigeration ring is fixedly arranged in the constant temperature plate; A fan is fixedly arranged on the earphone; A cavity for accommodating the constant temperature plate is formed in the filling part; and the earphone has a ventilation pipe connecting the ventilator and the cavity.

[0010] Furthermore, the surface of the wrapping portion penetrates into the cavity to form a heat dissipation hole.

[0011] Furthermore, the crossbeam contains distribution wires to connect the nerve stimulation electrodes, the electrocardiogram detection electrodes and the host.

[0012] A stimulation method of a neural stimulation system comprises the following steps: S1. Before wearing, use alcohol to clean the ear canal that contacts the earplug and the part behind the ear that contacts the ECG detection motor. After putting on the earphones, adjust the universal ball through the adjustment rod so that the earplug can be completely inserted into the ear canal. Make sure that when the earplug is inserted into the ear canal, the nerve stimulation electrode is in good contact with the ear canal, and the ECG detection electrodes on both sides are in good contact with the skin behind the ear. S2, start the nerve stimulation electrode to perform nerve stimulation; S3, the ECG detection module performs ECG detection on the patient; S4. During the stimulation process, the position of the earplug can be adjusted by rotating the adjustment block, and the stimulation position can be adjusted according to the patient's needs; S5. Start the fan to blow air to the constant temperature plate; control the semiconductor refrigeration ring to heat / cool through the control module, so that the air blown out of the heat dissipation hole is constant temperature and comfortable; this can improve the wearing comfort during nerve stimulation.

[0013] The beneficial effect of the present application is that it provides a neural stimulation system that can improve wearing comfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The drawings constituting a part of this application are used to provide a further understanding of this application, so that other features, purposes and advantages of this application become more obvious. The illustrative embodiment drawings and their descriptions of this application are used to explain this application and do not constitute an improper limitation on this application.

[0015] In addition, throughout the drawings, the same or similar reference numerals represent the same or similar elements. It should be understood that the drawings are schematic and that the components and elements are not necessarily drawn to scale.

[0016] In the attached picture: Figure 1 is an overall schematic diagram according to an embodiment of the present application; Figure 2 It is a diagram of the structure of the earphone; Figure 3 This is a diagram of the structure of the back of the headset; Figure 4 This is a half-section schematic diagram of the earphone; Figure 5It is a diagram of the explosion of the headphones; Figure 6 This is a diagram of the structure of the earplug.

[0017] Reference numerals: 1. Earplug; 2. Nerve stimulation electrode; 4. Main unit; 5. Earphone; 6. Crossbeam; 7. Universal ball; 8. Adjustment rod; 9. Moving rod; 10. Groove; 11. Adjustment slot; 12. Buffer cavity; 13. Elastic part; 14. Piston block; 15. Earmuff; 16. Wrapping part; 17. Filling part; 18. Constant temperature plate; 19. Semiconductor refrigeration ring; 20. Fan; 21. Cavity; 22. Heat dissipation hole; 23. Ventilation pipe; 24. Adjustment block. DETAILED DESCRIPTION

[0018] Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although certain embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be construed as being limited to the embodiments set forth herein. On the contrary, these embodiments are provided to provide a more thorough and complete understanding of the present disclosure. It should be understood that the drawings and embodiments of the present disclosure are only for exemplary purposes and are not intended to limit the scope of protection of the present disclosure.

[0019] It should also be noted that, for ease of description, only the parts related to the invention are shown in the drawings. In the absence of conflict, the embodiments and features in the embodiments of the present disclosure can be combined with each other.

[0020] It should be noted that the concepts such as "first" and "second" mentioned in the present disclosure are only used to distinguish different devices, modules or units, and are not used to limit the order or interdependence of the functions performed by these devices, modules or units.

[0021] It should be noted that the modifications of "one" and "plurality" mentioned in the present disclosure are illustrative rather than restrictive, and those skilled in the art should understand that unless otherwise clearly indicated in the context, it should be understood as "one or more".

[0022] The present disclosure will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0023] Embodiment 1 Reference Figure 1-Figure 6 , a neural stimulation system, comprising: an earplug 1, a neural stimulation electrode 2, an electrocardiogram detection electrode, a host 4, and an earphone 5; Specifically, the earphone 5 is constructed in a columnar shape and is provided with two, both of which can fit the left and right ears of the patient; the earplugs 1 are respectively arranged on the two earphones 5, and are constructed in a bullet-shaped shape so as to fit tightly with the ear canal wall; the nerve stimulation electrode 2 is fixedly arranged on the earplug 1 and can contact the ear canal wall, and comprises two electrode contacts, a positive electrode and a negative electrode, and realizes electrical stimulation of the vagus nerve of the ear by the flow of current between the positive and negative electrodes to realize nerve stimulation; the ECG detection electrode is fixedly arranged on the earphone 5, two are distributed on the back side of the left ear, the upper one is the reference electrode, the lower one is the positive electrode of the ECG detection electrode, and the rear side of the right ear is distributed, which corresponds to the positive electrode position of the left ear ECG detection electrode, and is the negative electrode of the ECG detection electrode; wherein, the host 4 comprises a control module, an ECG detection module, and a Bluetooth module; more specifically, the two earphones 5 are activated by the crossbeam 6 Dynamic connection, preferably, the earphone 5 is universally connected to the crossbeam 6 to adjust the position of the earphone 5; the crossbeam 6 contains distributed wires to connect the neural stimulation electrode 2, the ECG detection electrode and the control module; the Bluetooth module wirelessly interacts with the external intelligent terminal to view / adjust the stimulation parameters; the control module is used to adjust the stimulation parameters such as the current amplitude, frequency, pulse width of the neural stimulation electrode 2; the ECG detection module is used to detect the ECG signal and analyze HRV, and the analysis indicators mainly include the RR interval mean (MeanRR), the RR interval standard deviation (SDNN), the RR interval mean standard deviation (SDANN), the root mean square difference of adjacent RR intervals (RMSSD), the proportion of the number of adjacent RR interval differences exceeding 50ms to the total number of RR intervals (pNN50), and the instantaneous heart rate (HR).

[0024] During actual use, after the earphone 5 is worn, the earplug 1 is inserted into the ear canal, the nerve stimulation electrode 2 contacts the skin, and the ECG detection electrode contacts the part behind the ear; a smart terminal such as a mobile phone controls the nerve stimulation electrode 2 to output a certain stimulation current amplitude to the ear through a control module, and at the same time, the ECG detection electrode realizes the collection of ECG signals, and the sampling rate is 500Hz.

[0025] In another feasible embodiment, the earphone 5 is further provided with an adjustment component for adjusting the position of the earplug 1, and the adjustment component includes: a universal ball 7, an adjustment rod 8, and a moving rod 9; wherein the surface of the earphone 5 that fits the ear forms a groove 10 corresponding to the outward ball, and the universal ball 7 is embedded in the groove 10 so that the universal ball 7 can rotate in a universal direction in the groove 10; specifically, the surface of the universal ball 7 is in close contact with the inner wall of the groove 10 so that the universal ball 7 can be limited by friction after the universal ball 7 rotates; the universal ball 7 partially protrudes from the surface of the earphone 5 so that the universal ball 7 always protrudes from the surface of the earphone 5 during the rotation process; the inner wall of the groove 10 is penetrated in a direction away from the ear to form an adjustment groove 11; the adjustment rod 8 is fixedly arranged on the universal ball 7, and penetrates the adjustment groove 11 to be at least flush with the surface of the earphone 5; the diameter of the adjustment rod 8 is smaller than the inner diameter of the adjustment groove 11, so that turning the adjustment rod 8 can drive the universal ball 7 to rotate; More specifically, the earplug 1 is fixedly arranged on the moving rod 9, and the moving rod 9 is movably arranged in the universal ball 7; wherein, a buffer cavity 12 for guiding the movement of the moving rod 9 is formed in the adjusting rod 8, and the moving rod 9 is movably arranged in the buffer cavity 12 and connected by an elastic member 13; the elastic member 13 is a spring that always gives an elastic force to the adjusting rod 8 close to the ear canal; an adjusting block 24 is movably arranged at one end of the buffer cavity 12 away from the moving rod 9, and there is normal pressure gas between the adjusting block 24 and the moving rod 9; in actual use, by driving the adjusting block 24 to move in the buffer cavity 12, the gas between the adjusting block 24 and the moving rod 9 can be compressed; with such a configuration, the position of the earplug 1 can be adjusted during mental stimulation to improve stability; due to the compressibility of the gas, a fixed flexible force can also be given to the earplug 1 to reduce discomfort; More specifically, the adjustment block 24 is connected to the inner wall of the buffer chamber 12 by threads, and a piston block 14 is provided at the end of the adjustment block 24 located in the buffer chamber 12; thus, the pressure in the buffer chamber 12 can be adjusted by rotating the adjustment block 24, which is convenient for patients to operate by themselves.

[0026] In another more specific embodiment, the earmuff 15 is constructed in a ring shape and is fixedly arranged on the earphone 5 to completely wrap the ear; wherein the earmuff 15 includes a leather wrapping portion 16 and a filling portion 17 in the wrapping portion 16; the filling portion 17 can be filled with flexible materials such as cotton, sponge, silicone, etc. to improve the comfort when wearing; a constant temperature component is fixedly arranged in the filling portion 17 to adjust the surface temperature of the earmuff 15; the constant temperature component includes: a constant temperature plate 18, a semiconductor refrigeration ring 19, and a fan 20; Specifically, a cavity 21 is formed in the filling portion 17, and the cavity 21 extends around the circumference of the earmuff 15; the provision of the cavity 21 can improve the flexibility of the filling portion 17, making it more comfortable to wear; a constant temperature plate 18 is fixedly arranged in the filling portion 17, and a semiconductor refrigeration ring 19 is arranged in the constant temperature plate 18, and the semiconductor refrigeration ring 19 can adjust the temperature of the constant temperature plate 18, so that the temperature of the constant temperature plate 18 is adjusted between 5°C and 45°C; wherein, the surface of the wrapping portion 16 penetrates through the cavity 21 to form a heat dissipation hole 22, a fan 20 is arranged on the earphone 5, and a ventilation pipe 23 connecting the fan 20 and the cavity 21 is provided; specifically, a thermometer is also arranged on the earphone 5, and the thermometer is electrically connected to the control module; so that the control module adjusts the semiconductor refrigeration ring 19 according to the temperature to achieve heating / cooling.

[0027] Embodiment 2 The following steps are involved: S1. Before wearing, use alcohol to clean the ear canal in contact with the earplug 1 and the part behind the ear in contact with the electrocardiogram detection motor; after putting on the earphone 5, adjust the universal ball 7 through the adjustment rod 8 so that the earplug 1 can be completely inserted into the ear canal; ensure that when the earplug 1 is inserted into the ear canal, the nerve stimulation electrode 2 is in good contact with the ear canal, and the bilateral electrocardiogram detection electrodes are in good contact with the skin behind the ear; S2, the nerve stimulation electrode 2 transmits a biphasic square wave stimulation pulse 31 with a certain stimulation current amplitude 35 (0-67mA, step 0.05mA), stimulation period 36 (or frequency, 0-500Hz, step 1Hz), and stimulation pulse width 37 (0-2000μs, step 1μs) output by the control module to the ear canal, and at the same time, the ECG detection electrode realizes the collection of ECG signals, and the sampling rate is 500Hz; S3, setting the ECG detection module to perform bandpass filtering on the original ECG signal 32 (the upper and lower cutoff frequencies are 10 Hz and 20 Hz respectively), combining the module's own feature extraction function, obtaining the RR interval 38, and performing HRV analysis to obtain indicators such as MeanRR, SDNN, SDANN, RMSSD, pNN50, and HR; S4. During the stimulation process, the position of the earplug 1 is adjusted by rotating the adjustment block 24, and the stimulation position can be adjusted according to the patient's needs; S5. Start the fan 20 to blow air to the constant temperature plate 18; control the semiconductor refrigeration ring 19 to heat / cool through the control module, so that the air blown out of the heat dissipation hole is constant temperature and comfortable; this can improve the wearing comfort during nerve stimulation.

[0028] The above descriptions are only some preferred embodiments of the present disclosure and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the embodiments of the present disclosure is not limited to the technical solutions formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the above inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the embodiments of the present disclosure.

Claims

1. A neural stimulation system, characterized in that: include: Earphones, fixed on the patient's ears; An earplug, fixedly mounted on the earphone to be inserted into the patient's ear canal; A nerve stimulation electrode, which is disposed on the earplug and emits a stimulation current; Electrocardiogram detection electrodes are arranged on the earphone; A host connected to the nerve stimulation electrode and the electrocardiogram detection electrode; Among them, the earphones are provided with two and are connected by a crossbeam to correspond to the left and right ears of the patient; the nerve stimulation electrode comprises two electrode contacts, a positive electrode and a negative electrode, and electrical stimulation of the vagus nerve of the ear is achieved by the flow of current between the positive and negative electrodes; a control module and an intelligent terminal are also arranged in the host; the control module is electrically connected to the nerve stimulation electrode; an adjustment component is also arranged on the earphone to adjust the position of the earplug in the ear canal; and an earmuff is arranged on the earphone for completely covering the ear.

2. A neural stimulation system according to claim 1, characterized in that: The adjusting component comprises: A universal ball, rotatably disposed on the earphone; An adjusting rod, fixedly arranged on the universal ball; A moving rod, movably disposed in the universal ball and fixedly connected to the earplug; A buffer cavity is formed inside the adjusting rod to guide the moving rod toward / away from the ear canal; the moving rod is connected to the inner wall of the buffer cavity by an elastic member; an adjusting block is arranged at one end of the buffer cavity away from the moving rod; and there is normal pressure gas between the adjusting block and the moving rod.

3. A neural stimulation system according to claim 2, characterized in that: The surface of the earphone close to the ear is concave to form a groove corresponding to the universal ball; The universal ball is embedded in the groove so that the universal ball can rotate universally in the groove; The inner wall portion of the groove penetrates in a direction away from the ear portion to form an adjustment groove; The diameter of the adjusting groove is larger than the diameter of the adjusting rod.

4. A neural stimulation system according to claim 3, characterized in that: The adjusting block is connected to the inner wall of the buffer cavity via threads; A piston block is fixedly arranged at the end of the adjusting block; Wherein, the adjusting block is rotated to realize the movement of the piston block in the buffer chamber.

5. A neural stimulation system according to claim 1, characterized in that: The earmuff is constructed in a ring shape; The earmuff comprises a leather wrapping portion and a filling portion in the wrapping portion; Wherein, a constant temperature component is fixedly arranged in the filling portion to adjust the surface temperature of the earmuff.

6. A neural stimulation system according to claim 5, characterized in that: The thermostatic component comprises: A constant temperature plate, fixedly disposed in the filling portion; A semiconductor refrigeration ring is fixedly arranged in the constant temperature plate; A fan, fixedly mounted on the earphone; Wherein, a cavity for accommodating the constant temperature plate is formed in the filling portion; and the earphone has a ventilation pipe connecting the fan and the cavity.

7. A neural stimulation system according to claim 6, characterized in that: The surface of the wrapping portion penetrates into the cavity to form a heat dissipation hole.

8. A neural stimulation system according to claim 1, characterized in that: The crossbeam contains distribution wires to connect the nerve stimulation electrodes, the electrocardiogram detection electrodes and the host.

9. A stimulation method of a neural stimulation system, characterized in that: A neural stimulation system according to any one of claims 1 to 8, comprising the following steps: S1. Before wearing, use alcohol to clean the ear canal that contacts the earplug and the part behind the ear that contacts the ECG detection motor. After putting on the earphones, adjust the universal ball through the adjustment rod so that the earplug can be completely inserted into the ear canal. Make sure that when the earplug is inserted into the ear canal, the nerve stimulation electrode is in good contact with the ear canal, and the ECG detection electrodes on both sides are in good contact with the skin behind the ear. S2, start the nerve stimulation electrode to perform nerve stimulation; S3, the ECG detection module performs ECG detection on the patient; S4. During the stimulation process, the position of the earplug can be adjusted by rotating the adjustment block, and the stimulation position can be adjusted according to the patient's needs; S5. Start the fan to blow air to the constant temperature plate; control the semiconductor refrigeration ring to heat / cool through the control module, so that the air blown out of the heat dissipation hole is constant temperature and comfortable; this can improve the wearing comfort during nerve stimulation.

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