Transcutaneous vagus nerve stimulation device

Abstract

To provide a transcutaneous vagus nerve stimulation device that delivers stimulation other than electrical current to the ear comprising the external auditory canal and the auricle, allowing the general public to use it safely and casually, while achieving effective vagus nerve stimulation.SOLUTION: A transcutaneous vagus nerve stimulation device is configured to be worn on the ear for stimulating the vagus nerve transcutaneously, the stimulation being infrared or visible light irradiation, heat by thermal conduction, and / or vibration. It is preferable that the heat by thermal conduction is heat from a heating surface of a Peltier element 11a; the vibration is vibration from a piezoelectric element 12a; and the infrared or visible light irradiation is irradiation of infrared light or visible light emitted from an infrared LED 13a or a visible LED 13a.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a transcutaneous vagus nerve stimulation device, and more specifically to a transcutaneous vagus nerve stimulation device that is worn on the ear and transcutaneously stimulates the vagus nerve by infrared light or visible light irradiation, heat through thermal conduction, and / or vibration, as well as earphones, headphones, earmuffs, etc. that are equipped with the transcutaneous vagus nerve stimulation device. [Background technology]

[0002] Twenty percent of the vagus nerve fibers are efferent fibers originating from the brainstem that control the internal organs, peripheral vascular system, and parasympathetic nerves of the heart, while the remaining 80% are afferent fibers that relay sensory information from the periphery to the central nervous system. Afferent fibers are widely distributed throughout the body, including the heart, lungs, liver, adrenal medulla, gastrointestinal tract, and splenic flexure of the colon. The (cutaneous) auricular branch of the vagus nerve (ABVN) is a cutaneous branch of the vagus nerve that innervates the antihelix, tragus, and concha cavity, as shown in Figure 35.

[0003] Non-invasive stimulation of the vagus nerve has attracted attention in recent years due to the increasing number of people complaining of symptoms related to the vagus nerve, as well as the fact that stimulation has relatively few side effects and the stimulation device is relatively low cost.

[0004] However, many of the components and devices for stimulating the vagus nerve that are easy for the general public to use have been developed for areas other than the ear, such as the neck and shoulders, and there are relatively few for the ear. The patent documents listed below show that there are relatively few ear devices known for general use, rather than for medical use.

[0005] Patent document 1 describes a casing having at least a stimulating electrode and a reference electrode, and the casing has a protrusion that is inserted into the ear canal, causing an electric current to flow from the protrusion into the ear canal, thereby stimulating a person's nerves transcutaneously.

[0006] Patent Document 2 describes an electrical stimulation device having an electrode that electrically stimulates nerves in the ear canal, and the stimulating end of the electrode is said to stimulate the contact point with the trigeminal nerve, facial nerve, or glossopharyngeal nerve in the ear canal.

[0007] Patent document 3 describes a device for transcutaneously stimulating peripheral nerves, including the auricular branch of the vagus nerve, which is equipped with a stimulating electrode and a reference electrode and applies electrical stimulation to the sympathetic or parasympathetic nerve.

[0008] Patent document 4 describes an auricular nerve stimulation device that is configured to stimulate the auricular branch of the vagus nerve (ABVN) and can be worn by the user. The stimulation is electrical, and the device is miniaturized and all elements are incorporated into the electronic circuitry on the circuit board.

[0009] However, most of the known methods and devices for stimulating the vagus nerve, not limited to the ear, use electric current, and more particularly, as described above, almost all stimulations given to the ear use electric current.

[0010] As mentioned above, in recent years, the number of people complaining of symptoms related to the vagus nerve has been increasing, but some people find electrical current stimulation uncomfortable, it is cumbersome to operate, and there is a possibility of side effects, so electrical current stimulation devices for the "ears and other parts of the face" are not approved in some countries. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] Special Publication No. 2008-528145 [Patent Document 2] Special Publication No. 2019-517381 [Patent Document 3] Special Publication No. 2020-525252 [Patent Document 4] Special Publication No. 2023-503291 Summary of the Invention [Problem to be solved by the invention]

[0012] The present invention has been made in consideration of the above-mentioned background art, and its objective is to provide a device that can be used safely and easily by the general public and that can effectively stimulate the vagus nerve by applying "stimuli other than electric current" to "the ear including the external auditory canal and the auricle." [Means for solving the problem]

[0013] As a result of extensive research into solving the above-mentioned problems, the inventors discovered or focused on the fact that, anatomically, the auricular branch of the vagus nerve (ABVN) is distributed in the "ear including the external auditory canal and auricle," particularly in a specific location within the ear, and discovered that the above-mentioned problems can be solved by stimulating this location using a specific method or means, thereby achieving the present invention.

[0014] That is, the present invention provides a device that is worn in the ear and transcutaneously stimulates the vagus nerve, The present invention provides a transcutaneous vagus nerve stimulation device, characterized in that the stimulation is infrared light or visible light irradiation, heat by thermal conduction, and / or vibration.

[0015] The present invention also provides the above-mentioned transcutaneous vagus nerve stimulation device, wherein the "heat generated by thermal conduction" is heat generated from the heat generating surface of a Peltier element.

[0016] The present invention also provides the above-described percutaneous vagus nerve stimulation device, wherein the vibration is generated by a piezoelectric element.

[0017] The present invention also provides the above-mentioned transcutaneous vagus nerve stimulation device, wherein the infrared light or visible light irradiation is infrared light or visible light irradiation emitted from an infrared LED or a visible LED.

[0018] The present invention also provides the above-mentioned transcutaneous vagus nerve stimulation device, in which the stimulation is applied to the vicinity of the external auditory canal, the inner surface of the ear canal, the tragus, the concha, and / or the cavum concha in the ear.

[0019] The present invention also provides the transcutaneous vagus nerve stimulation device, wherein the transcutaneous vagus nerve stimulation device is in the shape of an earphone, a headphone, or an earpiece.

[0020] The present invention also provides the above-mentioned transcutaneous vagus nerve stimulation device, which is capable of transmitting sound.

[0021] The present invention also provides the transcutaneous vagus nerve stimulation device, which is shaped like a canal-type earphone, and the Peltier element is installed on the outer surface of the earpiece of the canal-type earphone, so that the heat is applied to the inner surface of the ear canal in the ear.

[0022] The present invention also provides the transcutaneous vagus nerve stimulation device, which is in the form of a canal-type earphone, an inner-ear-type earphone, a bone conduction earphone, an ear-hook-type earphone, a headphone, or an earmuff, and the piezoelectric element is installed on the surface or inside of the earphone, the headphone, or the earmuff, so that the vibrations are applied to the external auditory canal and / or the pinna of the ear.

[0023] The present invention also provides the transcutaneous vagus nerve stimulation device, which is in the form of a canal-type earphone, an in-ear-type earphone, a bone conduction earphone, an ear-hook-type earphone, a headphone, or an earmuff, and the infrared LED or visible LED is installed on the surface of the earphone, the headphone, or the earmuff, so that the infrared light or visible light is irradiated onto the external auditory canal and / or the pinna of the ear.

[0024] The present invention also provides earphones, headphones, or earmuffs that include the above-described transcutaneous vagus nerve stimulation device. [Effects of the Invention]

[0025] According to the present invention, it is possible to provide a device that can stimulate the vagus nerve very effectively, while being simpler and more reassuring to use than electrical stimulation, which some people find uncomfortable or frightening to use, is cumbersome to operate, and may cause discomfort or side effects after use.

[0026] Furthermore, in some countries, including Japan, the sale of electrical stimulation devices for parts of the face, including the ears, requires government approval. However, the transcutaneous vagus nerve stimulation device of the present invention is highly safe and does not require government approval, so it can be used easily and with peace of mind.

[0027] The transcutaneous vagus nerve stimulation device of the present invention can highly effectively stimulate the auricular branch of the vagus nerve (ABVN), thereby alleviating symptoms related to the vagus nerve, providing relaxation, and ultimately achieving various beneficial effects due to vagus nerve stimulation in a simple, safe, and effective manner.

[0028] Specific examples of such beneficial effects include improvement of the intestinal environment, activation of the brain, improvement and treatment of autism, dementia, post-stroke paralysis, schizophrenia, depression, Parkinson's disease, epilepsy, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, ulcerative colitis, Crohn's disease, irritable bowel syndrome, COVID-19, inflammatory diseases, cancer, dizziness, headache, tinnitus, immune function, myocardial infarction, arrhythmia, menopausal disorders, menstrual pain, insomnia, anxiety disorders, PTSD, etc.

[0029] The stimulation provided by the transcutaneous vagus nerve stimulation device of the present invention is infrared or visible light irradiation, heat generated by thermal conduction, and / or vibration, so it is not only safer, more reliable, and easier to use than electrical current stimulation, but also makes it possible to effectively stimulate the vagus nerve transcutaneously.

[0030] Furthermore, the device can be made extremely small in size, and can be manufactured easily and inexpensively. The "stimuli" in the present invention, such as heat by thermal conduction, vibration, and infrared or visible light irradiation, can all be made much smaller than voltage application (current flow), and can be easily and inexpensively incorporated into devices.

[0031] Specifically, if heat from a Peltier element is used as the "heat generated by thermal conduction," the device can be made extremely small, and the transcutaneous vagus nerve stimulation device of the present invention can be obtained easily and inexpensively. Furthermore, if vibrations from a piezoelectric element are used as the "vibrations," the device can be made extremely small, and the transcutaneous vagus nerve stimulation device of the present invention can be obtained easily and inexpensively. Furthermore, if the above-mentioned "infrared light or visible light irradiation" is infrared light or visible light irradiation from an infrared LED or a visible LED, the device can be made extremely small, and the transcutaneous vagus nerve stimulation device of the present invention can be obtained easily and inexpensively.

[0032] Furthermore, if the transcutaneous vagus nerve stimulation device of the present invention is shaped like an in-ear earphone, an inner ear earphone, a bone conduction earphone, an ear-hook earphone, headphones, earmuffs, or the like, in other words, earphones, headphones, earmuffs, or the like equipped with the transcutaneous vagus nerve stimulation device of the present invention can be used easily, safely, and effectively at any time.

[0033] Furthermore, if the earphones or headphones mentioned above are capable of playing music, sound effects, voices, etc., the effects of stimulating the vagus nerve can be enhanced in cooperation with the "music and other sounds." [Brief explanation of the drawings]

[0034] [Figure 1] FIG. 1 shows a preferred location (gauze-covered location) on the ear to stimulate using the transcutaneous vagus nerve stimulation device of the present invention, which is an area innervated by the vagus nerve through the cutaneous auricular branch (ABVN) of the ear. [Figure 2] FIG. 1 is a diagram showing the location of the "ear consisting of the external auditory canal and pinna" stimulated by the transcutaneous vagus nerve stimulation device of the present invention. [Figure 3] 1A and 1B are diagrams showing an example of an in-ear earphone equipped with a transcutaneous vagus nerve stimulation device of the present invention. (a) An "earpiece not covered with a flexible ear tip" equipped with a Peltier element and / or a piezoelectric element. (b) An "earpiece covered with a flexible ear tip" equipped with a Peltier element and / or a piezoelectric element. (c) An "earpiece covered with a flexible ear tip" equipped with an infrared LED or a visible LED. [Figure 4] 1A and 1B are diagrams showing an example of an inner-ear type earphone equipped with a transcutaneous vagus nerve stimulation device according to the present invention. (a) shows a diaphragm (vibration plate), a (diaphragm) support, etc. equipped with a Peltier element and / or a piezoelectric element. (b) shows a diaphragm (vibration plate), a (diaphragm) support, etc. equipped with an infrared LED or a visible LED. [Figure 5]1 shows an example of headphones equipped with a transcutaneous vagus nerve stimulation device according to the present invention. (a) Headphones equipped with a Peltier element, a piezoelectric element, and / or an infrared LED or a visible LED (soft objects such as sponges that come into direct contact with the ears are not shown). (b) A diaphragm (vibration plate), a (diaphragm) support, etc. equipped with a Peltier element, a piezoelectric element, and an infrared LED or a visible LED are shown. [Figure 6] FIG. 2 shows the locations of tables, graphs, etc. of (1) to (8) in FIGS. 7 to 24. [Figure 7] FIG. 1 shows the results of measurement by HRSPE before thermal stimulation of subject 1 in Example 1. [Figure 8] FIG. 1 shows the results of measurement by HRSPE after thermal stimulation of subject 1 in Example 1. [Figure 9] FIG. 1 shows the results of measurement by HRSPE before thermal stimulation of subject 2 in Example 1. [Figure 10] FIG. 1 shows the results of measurement by HRSPE after thermal stimulation of subject 2 in Example 1. [Figure 11] FIG. 1 shows the results of measurement by HRSPE before thermal stimulation on subject 3 in Example 1. [Figure 12] FIG. 1 shows the results of measurement by HRSPE after thermal stimulation on subject 3 in Example 1. [Figure 13] FIG. 10 is a diagram showing the results of measurement by HRSPE before vibration stimulation of subject 1 in Example 2. [Figure 14] FIG. 10 is a diagram showing the results of measurement by HRSPE after vibration stimulation of subject 1 in Example 2. [Figure 15] FIG. 10 is a diagram showing the results of measurement by HRSPE before vibration stimulation for subject 2 in Example 2. [Figure 16] FIG. 10 is a diagram showing the results of measurement by HRSPE after vibration stimulation of subject 2 in Example 2. [Figure 17]FIG. 10 is a diagram showing the results of measurement by HRSPE before vibration stimulation for subject 3 in Example 2. [Figure 18] FIG. 10 is a diagram showing the results of measurement by HRSPE after vibration stimulation on subject 3 in Example 2. [Figure 19] FIG. 10 shows the results of HRSPE measurement of subject 1 before infrared irradiation stimulation in Example 3. [Figure 20] FIG. 10 shows the results of HRSPE measurement of subject 1 after infrared irradiation stimulation in Example 3. [Figure 21] FIG. 10 shows the results of HRSPE measurement of subject 2 before infrared irradiation stimulation in Example 3. [Figure 22] FIG. 10 shows the results of HRSPE measurement of subject 2 after infrared irradiation stimulation in Example 3. [Figure 23] FIG. 10 shows the results of HRSPE measurement of subject 3 before infrared irradiation stimulation in Example 3. [Figure 24] FIG. 10 shows the results of HRSPE measurement of subject 3 after infrared irradiation stimulation in Example 3. [Figure 25] FIG. 10 shows the results of HRSPE measurement of subject 4 before infrared irradiation stimulation in Example 4. [Figure 26] FIG. 10 shows the results of HRSPE measurement of subject 4 after infrared irradiation stimulation in Example 4. [Figure 27] FIG. 10 shows the results of HRSPE measurement of subject 5 before infrared irradiation stimulation in Example 4. [Figure 28] FIG. 10 shows the results of HRSPE measurement of subject 5 after infrared irradiation stimulation in Example 4. [Figure 29] FIG. 10 is a diagram showing the results of measurement by HRSPE on subject 6 before infrared irradiation stimulation in Example 4. [Figure 30] FIG. 10 shows the results of HRSPE measurement of subject 6 after infrared irradiation stimulation in Example 4. [Figure 31]FIG. 10 shows the results of HRSPE measurement of subject 7 before infrared irradiation stimulation in Example 4. [Figure 32] FIG. 10 shows the results of HRSPE measurement of subject 7 after infrared irradiation stimulation in Example 4. [Figure 33] FIG. 10 shows the results of HRSPE measurement of subject 8 before infrared irradiation stimulation in Example 4. [Figure 34] FIG. 10 shows the results of HRSPE measurement of subject 8 after infrared irradiation stimulation in Example 4. [Figure 35] FIG. 1 illustrates the innervation of the vagus nerve by the cutaneous auricular branch (ABVN) and illustrates the principle of action of the transcutaneous vagus nerve stimulation device of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0035] The present invention will be described below, but the present invention is not limited to the following specific embodiments and can be modified as desired within the scope of the technical concept.

[0036] The present invention is a transcutaneous vagus nerve stimulation device that is worn on the ear and stimulates the vagus nerve transcutaneously, characterized in that the stimulation is infrared light or visible light irradiation, heat by thermal conduction, and / or vibration. In other words, the present invention is a transcutaneous vagus nerve stimulation device that is worn on the ear and stimulates the vagus nerve transcutaneously, characterized in that the stimulation is achieved by a stimulation member 13 that uses infrared light or visible light irradiation, a stimulation member 11 that uses heat, and / or a stimulation member 12 that uses vibration.

[0037] Here, the "ear" refers to the ear canal and the pinna (see Figures 1 and 2). Hereinafter, the "transcutaneous vagus nerve stimulation device of the present invention" may be abbreviated as the "device of the present invention."

[0038] <Location of the transcutaneous vagus nerve stimulation device and the stimulation location of the device> The location where the transcutaneous vagus nerve stimulation device of the present invention stimulates is the ear, which consists of the external auditory canal and the auricle. However, the attachment tool or the like may be placed on a location other than the ear, such as the head, behind the ear, or forehead.

[0039] The device of the present invention provides specific stimulation to at least the "ear consisting of the external auditory canal and the auricle," and it is preferable that the stimulation be provided to the vicinity of the external auditory canal, the inner surface of the ear canal, the tragus, the cymba concha, and / or the cavum concha (see Figures 1 and 2). The "external auditory canal" refers to the tubular part connecting the external auditory canal and the tympanic membrane.

[0040] The stimulation locations are connected by "and / or," and one or more of the ear locations may be stimulated simultaneously. Furthermore, in the present invention, the stimuli are infrared light or visible light irradiation, heat due to thermal conduction, and / or vibration, and these three types of stimuli may individually stimulate one or more locations of the above-mentioned location, or two or more of these three types of stimuli may be combined, i.e., two or more types of stimuli may stimulate one or more locations of the above-mentioned location (see Figures 1 to 3). Particularly preferred locations for each of the stimuli, ie, infrared light or visible light irradiation, heat by thermal conduction, and vibration, will be described below for each stimulus.

[0041] <Types of stimuli and common points for each stimulus> The device of the present invention percutaneously stimulates the vagus nerve by infrared or visible light irradiation, heat via thermal conduction, and / or vibration. However, the present invention does not exclude the simultaneous use of other stimuli such as electrical stimulation or pressure stimulation using a separate device.

[0042] In the device of the present invention, it is preferable that the stimulation be applied to the vicinity of the external auditory canal, the inner surface of the ear canal, the tragus, the concha, and / or the cavum concha in the ear, in order to effectively stimulate the (cutaneous) auricular branch of the vagus nerve (ABVN) (see Figures 1 and 2).

[0043] When the device is used in the form of earphones 20, headphones 30, earmuffs 40, etc., it may be incorporated into the form itself (see, for example, Figures 3 to 5), or it may be located away from the ear and transmit stimuli such as infrared or visible light irradiation, heat via thermal conduction, or vibration to the ear. The "transmission method" can be, in the above order, a heat conduction wire, a vibration transmission wire, an optical fiber, etc. When the device of the present invention is located away from the ear, it is preferable that the device is portable or that it can be carried, installed or worn on a part of the human body other than the ear.

[0044] Furthermore, as will be described later, when used in the form of earphones 20, headphones 30, earmuffs 40, etc., the sound may be transmitted, in that order, via ear tips (ear pads) 21c made of (silicone) rubber or the like (see, for example, Figure 3(b)), or via a cushion (soft material such as sponge) in the part that comes into contact with the ear (not shown).

[0045] The power source used for infrared or visible light irradiation, heat by thermal conduction, and vibration may be embedded in the device (built-in power source), or may be one that transmits power from the power source to the device via an electric wire or the like (connected to an external power source by a cord).

[0046] The type of power source is not particularly limited, and specific examples include secondary batteries such as lithium ion batteries and nickel-metal hydride batteries; dry batteries such as alkaline dry batteries, manganese dry batteries and lithium dry batteries; button batteries such as alkaline button batteries, silver oxide batteries and air button batteries; and 100V household power sources.

[0047] <<Heat by thermal conduction>> The type of heating element (heat-stimulating member 11) for "heat conduction" is not particularly limited, and examples include heat from a Peltier element; heat from IH (electromagnetic induction heating); heat from resistance heating (heat generated by passing an electric current through an electrical resistance wire); and infrared heat (heat rise in a material other than the ear when infrared rays are irradiated onto the material); etc. The thermal stimulation from these may be achieved by directly applying (contacting) the above-mentioned heat generating element itself (thermal stimulation member 11) to the ear canal, auricle, or other ear skin, thereby providing thermal stimulation from the heat generating element itself (thermal stimulation member 11), or by applying (contacting) or bringing the element close to another element to heat that element, thereby providing thermal stimulation from that element.

[0048] The temperature of the heating element (thermal stimulation member 11) is not particularly limited as long as it is determined taking into consideration that the temperature can become the ear skin temperature, but is preferably 36°C or higher and 45°C or lower, more preferably 37°C or higher and 43°C or lower, and particularly preferably 38°C or higher and 41°C or lower.

[0049] <<<Heat from Peltier elements>>> Among these, the type of "heat by thermal conduction" is preferable because heat from the heat generating surface of the Peltier element 11a can be made smaller and lighter; it has a fast temperature response and quickly reaches the specified temperature; it requires little power; it is easy to attach to earphones 20, headphones 30, earmuffs 40, etc.; and it does not produce noise or vibration. A known Peltier element can be used as the Peltier element 11a. When a direct current is passed through the Peltier element 11a in a certain direction, one side of the element absorbs heat (cools) and the other side generates heat (heats), so it is preferable to face the heat-generating (heatable) side toward the ear canal, auricle, or other skin of the ear.

[0050] <<Vibration>> The type of vibration in the vibration stimulation member 12 is not particularly limited, and examples include vibration from a piezoelectric element; vibration caused by the rotation of a motor (eccentric motor) with an eccentric weight attached; a linear resonant actuator; and vibration caused by passing an electric current through a coil in a magnetic field. The vibrations from these may be vibrations of the vibration stimulation member 12 (the element or device described above) itself when it is placed directly against (contacted with) the ear canal, auricle, or other ear skin, or may be vibrations that are transmitted to the ear by placing the vibration stimulation member 12 against (contacting) another member and transmitting the vibrations to that member, which then travels to the ear.

[0051] <<<Vibrations from piezoelectric elements>>> In terms of the type, element, and principle of vibration, vibration from the piezoelectric element 12a is preferable because it can be made smaller, lighter, and thinner; it requires less power; it is easy to incorporate into earphones 20, headphones 30, earmuffs 40, etc.; and it matches the device of the present invention, in which even slight vibrations are sufficient. A known piezoelectric element can be used as the piezoelectric element 12a.

[0052] The piezoelectric element 12a is preferably a thin piezoelectric element having a thickness of 3 μm to 100 μm, and the thickness is particularly preferably 5 μm to 50 μm.

[0053] The amplitude of the vibration is not particularly limited, but is preferably 0.1 μm or more and 100 μm or less, more preferably 0.3 μm or more and 30 μm or less, and particularly preferably 1.0 μm or more and 10 μm or less.

[0054] If the amplitude is too small, the vibration may not have the aforementioned effect on the ear (ear canal, pinna). On the other hand, if the amplitude is too large, vibration noise may be generated, discomfort may be caused, etc. The skin of the ear canal and auricle does not have subcutaneous tissue and the auricle cartilage is located directly below the skin, so it is thinner and more susceptible to damage than the skin of other parts of the body, and therefore it is preferable not to make the amplitude too large to avoid damage caused by excessive stimulation.

[0055] The frequency of the "vibration from the piezoelectric element" is preferably 1 Hz or more and 1000 Hz or less, more preferably 3 Hz or more and 300 Hz or less, and particularly preferably 10 Hz or more and 100 Hz or less. If the frequency is too low, the vibration may not have any effect on the ear (external ear canal, pinna), whereas if the frequency is too high, the vibration may produce a sound (audible) if the amplitude is large, or the vibration sound may be unpleasant.

[0056] Various types of piezoelectric element 12a can be used without any particular limitation, but a micro electro mechanical system (MEMS) is particularly preferable from the above-mentioned point of view.

[0057] <<Infrared or visible light irradiation>> The type and method of infrared or visible light irradiation in the stimulating member 13 by infrared or visible light irradiation is not particularly limited, and infrared or visible light irradiation from a light source such as an infrared LED or visible LED 13a is preferably used.

[0058] The "infrared light or visible light" used in the "irradiation of infrared light or visible light" in the transcutaneous vagus nerve stimulation device of the present invention generally refers to light with a wavelength of 360 nm or more and 1 mm or less. The wavelength of the "infrared light or visible light" may be, for example, 380 nm or more, 400 nm or more, 450 nm or more, 500 nm or more, 550 nm or more, 600 nm or more, 650 nm or more, 700 nm or more, 740 nm or more, 780 nm or more, or 800 nm or more. Furthermore, the wavelength of the "infrared light or visible light" may be, for example, 25 μm or less, 2500 nm or less, 1000 nm or less, 950 nm or less, 900 nm or less, 850 nm or less, or 830 nm or less.

[0059] When "irradiating infrared light or visible light" in the transcutaneous vagus nerve stimulation device of the present invention, light in the above wavelength range may be irradiated simultaneously with light in another wavelength range.

[0060] If the wavelength of the "infrared light or visible light" is too short, the vibration may not have any effect on the ear (external ear canal, auricle), while if the wavelength is too long, the vibration may become hot or the vibration may not have any effect on the ear (external ear canal, auricle).

[0061] The infrared light used for "irradiating infrared light or visible light" in the transcutaneous vagus nerve stimulation device of the present invention is preferably near-infrared light or mid-infrared light, and particularly preferably near-infrared light (light of 700 nm or more and 2500 nm or less).

[0062] When visible light is used for "infrared or visible light irradiation" in the transcutaneous vagus nerve stimulation device of the present invention, it is preferable to use a clear color such as blue, green, or red (e.g., a single color, the three primary colors of light, etc.) to achieve psychological effects such as a sense of ease of use. Colors give a sense of security and ease of use, and red in particular has (psychological) effects such as anti-aging. In addition, single-color visible LEDs are easy to obtain.

[0063] <<Irradiation from infrared LED or visible LED>> In the present invention, the stimulus member 13 using infrared or visible light irradiation, that is, the infrared or visible light irradiation, is preferably infrared or visible light irradiation irradiated from the infrared LED 13a or visible LED 13a. The infrared LED 13a or the visible LED 13a may be a known one, and the preferred wavelength range for irradiation is as described above.

[0064] <Particularly preferred specific embodiments of the transcutaneous vagus nerve stimulation device> The above-mentioned transcutaneous vagus nerve stimulation device of the present invention is particularly preferably in the form of earphones 20, headphones 30, or earmuffs 40, because it allows the user to simultaneously listen to music or other sounds if necessary; in the case of earmuffs 40, it allows the user to keep warm at the same time; the device has a shape that is suitable for the device of the present invention; and a general-purpose shape can be used as is.

[0065] <<Earphones, headphones, and earmuffs equipped with Peltier elements>> In the present invention, when the stimulus is "heat due to thermal conduction" and the heat is from a Peltier element 11a, the device of the present invention is preferably in the shape of an in-ear earphone 21, an in-ear earphone 22, a bone conduction earphone, an ear-hook earphone, a headphone 30, or an earmuff 40, and a Peltier element 11a is installed on the surface or inside the earphone 20, the headphone 30, or the earmuff 40 so that the heat is applied to the ear canal and / or the pinna of the ear (see, for example, FIGS. 3 to 5).

[0066] In the present invention (this specification, etc.), both earphones in which ear tips (ear pads) 21c made of a material with a low elastic modulus, such as silicone rubber, are attached to the outside of the earpiece 21a, as shown in Figures 3(b) and 3(c), and earphones in which the earpiece 21a is exposed (dynamic type earphones), as shown in Figure 3(a), are also referred to as "canal type earphones."

[0067] It is also preferable that the "heat by thermal conduction" is provided through earphones 20, headphones 30, or earmuffs 40 in combination with other stimuli such as "vibration" or "irradiation with infrared or visible light" (e.g., Figures 3(a)(b), 4(a), and 5(a)(b)).

[0068] Since applying thermal stimulation to the inner surface of the ear canal is particularly effective in stimulating the vagus nerve, it is particularly preferable that the device of the present invention is in the shape of a canal-type earphone 21, as shown in Figures 3(a) and 3(b), and that a Peltier element 11a is installed on the outer surface of an earpiece 21a of the canal-type earphone 21 so that the heat is applied to the inner surface of the ear canal in the ear. It is also particularly preferable that a Peltier element 11a is installed in the canal-type earphone body 21a so that the heat can be applied to the tragus, the navicular vessel of the concha, the cavity of the concha, etc. (FIG. 3(b)).

[0069] In the case of inner-ear type earphones 22, it is particularly preferable that a Peltier element 11a is installed on the outer (diaphragm) support 22c of the diaphragm (vibration plate) 22a or on the inner-ear type earphone body 22b, so that the heat can be applied to the tragus, concha navicularis, cavity of the concha, etc. (Figure 4(a)).

[0070] In FIG. 5(a), since there is actually a cushion (soft material) such as sponge in the part that comes into contact with the ear, the Peltier element 11a and the piezoelectric element 12a are hidden by it and are therefore drawn with dashed lines. FIG. 5(b) is a view of the diaphragm (vibration plate) 22a seen from directly above, with the "cushion (soft material such as sponge)" that comes into contact with the ear peeled off.

[0071] In the case of headphones 30, it is particularly preferable that a Peltier element 11a is installed on the (diaphragm) support 30c or housing 30b around the outside of the diaphragm (vibration plate) 30a, so that the heat can be applied to the tragus, the concha navicularis, the cavity of the concha, etc. (Figures 5(a)(b)).

[0072] When the earpiece 40 is installed, it is preferable that the earpiece 40 be installed in a location similar to that of the headphones 30 described above.

[0073] <<Earphones, headphones, and earmuffs equipped with piezoelectric elements>> When the stimulus in the present invention is "vibration" and the vibration is from the piezoelectric element 12a, the device of the present invention is preferably in the form of a canal-type earphone 21, an in-ear-type earphone 22, a bone conduction earphone, an ear-hook-type earphone, a headphone 30, or an earmuff 40, and the piezoelectric element 12a is installed on the surface or inside of the earphone 20, the headphone 30, or the earmuff 40 so that the vibration is applied to the ear canal and / or the pinna of the ear (see, for example, Figures 3(a)(b), 4(a), and 5(a)(b)).

[0074] The particularly preferred installation locations of the piezoelectric element 12a in the canal-type earphone 21, the inner-ear-type earphone 22, the headphones 30, and the earmuffs 40 are the same as the preferred and particularly preferred installation locations of the Peltier element 11a described above.

[0075] It is also preferable that the "vibration" is applied from earphones 20, headphones 30, or earmuffs 40 in combination with other stimuli such as "heat due to thermal conduction" or "irradiation with infrared or visible light" (e.g., Figures 3(a)(b), 4(a), and 5(a)(b)).

[0076] <<Earphones, headphones, and earmuffs equipped with infrared or visible LEDs>> When the stimulus in the present invention is "irradiation with infrared light or visible light" and the infrared light or visible light irradiation is from an infrared LED 13a or a visible LED 13a, the device of the present invention is preferably in the shape of a canal-type earphone 21, an in-ear-type earphone 22, a bone-conduction earphone, an ear-hook-type earphone, a headphone 30, or an earmuff 40, and the infrared LED 13a or visible LED 13a is disposed on the surface of the earphone 20, the headphone 30, or the earmuff 40, so that the infrared light or visible light is irradiated onto the ear canal and / or the pinna of the ear (see, for example, FIG. 3(c), FIG. 4(b), and FIG. 5(a)(b)). When installing an infrared LED or visible LED in headphones 30, it is preferable to install it on the (diaphragm) support 30c, avoiding "cushion / soft material such as sponge" that comes into direct contact with the ear (Figure 5(b)).

[0077] It is particularly preferable that the infrared LED 13a or visible LED 13a is installed on the outer surface of the earpiece 21a of the earphone 20 so that the infrared light or visible light is irradiated onto the inner surface of the ear canal and / or the vicinity of the ear canal (FIG. 3(c)).

[0078] It is also preferable that the "infrared light or visible light irradiation" is combined with other stimuli such as "heat by thermal conduction" or "vibration" and is applied through earphones 20, headphones 30, or earmuffs 40 (e.g., Figures 5(a)(b)).

[0079] <<Common items for all specific forms>> The above-mentioned "items in the shape of earphones 20 and headphones 30," more specifically, "items in the shape of canal-type earphones 21, in-ear earphones 22, bone conduction earphones, ear-hook earphones, and headphones 30," preferably have the original function of the earphones 20 and headphones 30, "being able to transmit sound." The sound signal may be transmitted wirelessly (via Bluetooth) or wired (with an earphone jack, etc.).

[0080] If "sounds such as music" are heard from the earphones 20 or headphones 30 in addition to the above-described stimulation of the present invention, the vagus nerve is stimulated synergistically, resulting in extremely favorable effects.

[0081] The present invention also relates to an earphone 20, a headphone 30, or an earpiece 40, characterized in that it comprises a transcutaneous vagus nerve stimulation device of the present invention. The earphones 20, headphones 30, and earmuffs 40 have shapes suitable for use with the transcutaneous vagus nerve stimulation device of the present invention, and furthermore, they also achieve their original purposes of "hearing sound" and "feeling warm in the ears," making them a good match for the device of the present invention.

[0082] <Action / Principle> The vagus nerve contains three types of fibers: highly myelinated A fibers with a low activation threshold, lightly myelinated B fibers, and unmyelinated C fibers with a high activation threshold. The (cutaneous) auricular branch of the vagus nerve (ABVN) is a cutaneous branch of the vagus nerve that innervates the antihelix, greater auricle, tragus, and cavity of the concha. Currently, there is still some debate as to how the external auricle is innervated, but the innervation of the auricle is shown in Figure 25.

[0083] In anatomical studies, ABVN could be observed in 94% (17 / 18) of cases, and all ABVN were observed to be distributed in the external auditory canal and pinna. Therefore, it is believed that the excellent effects of the present invention can be obtained with a device such as the device of the present invention, which is attached to the "ear including the external auditory canal and auricle" and stimulates the vagus nerve transcutaneously with heat via thermal conduction, vibration, or infrared or visible light irradiation.

[0084] In addition, transcutaneous stimulation of the vagus nerve with electrical current has already been studied, and this research suggests that the tragus, cymba concha, and cavum concha are the locations where cutaneous afferent vagus nerves are distributed. Therefore, it is believed that even if the stimulation applied to the area was not electrical but rather "heat by thermal conduction, vibration, or infrared or visible light irradiation," it produced the same therapeutic effect as electrical stimulation. Moreover, the non-invasive stimulation of the cervical branch of the vagus nerve in the present invention, unlike electrical stimulation, has minimal side effects, is low cost, and is safe and secure. [Example]

[0085] The present invention will be explained in more detail below by way of examples and comparative examples, but the present invention is not limited to these examples as long as it does not depart from the gist of the invention. Example group A and Example group B differ in the subjects and implementation time.

[0086] [Example Group A] The following <Location where stimulation was applied and purpose of measurement>, <Subject and measurement environment>, and <Measurement device and measurement method (system) for parasympathetic and sympathetic nerves before and after stimulation> are common to all embodiments and measurement examples in Example Group A.

[0087] <Location of stimulation and purpose of measurement> Using the existing device described below, which is capable of applying heat through thermal conduction, vibration, or infrared or visible light irradiation, stimulation (heat through thermal conduction, vibration, infrared or visible light irradiation) was applied to the vicinity of the external auditory canal (around the ear canal), the inner surface of the ear canal, the tragus, the cymba concha, and / or the cavum concha in the "ear including the ear canal and auricle" as shown in Figures 1 and 2. The effects of the transcutaneous vagus nerve stimulation device were determined by comparing the measurement results of the parasympathetic nerve, sympathetic nerve, etc. before and after the stimulation, using the device described below.

[0088] <Subjects and measurement environment> The subjects were three men and women aged 18 to 65. Subject 1: 32-year-old woman Subject 2: 29-year-old male Subject 3: 52-year-old male

[0089] The measurements were carried out after meeting all of the following conditions. 1. Subjects must have had a meal for at least 3 hours. 2. Indoors at 26°C 3. No medications that affect the autonomic nervous system, such as sleeping pills or antihypertensive drugs 4. The bladder is not full 5. No pain such as menstrual cramps or headaches 6. No extreme fatigue or lack of sleep 7. It has been more than an hour since you exercised 8. There are no barometric pressure abnormalities in the weather. 9. Not suffering from malignant tumors, asthma, collagen disease, immune disorders, neuropsychiatric disorders, etc. 10. Allow at least 30 minutes between stimulation and measurement. 11. The stimulation location (ear including the ear canal and pinna) should be the left ear.

[0090] <Devices and methods (systems) for measuring parasympathetic and sympathetic nerves before and after stimulation> Measurements of the autonomic nervous system (parasympathetic and sympathetic nervous systems) were performed using the Heart Rhythm Scanner PE, an autonomic nervous system measurement system manufactured by Biocom, Inc. in the United States. The measurement was carried out using a PPG wired sensor (HRS 07UE07UE) according to the method described in the instruction manual for the measuring device. In this specification, the above-mentioned "measurement device for autonomic nerves (parasympathetic nerves, sympathetic nerves) and the like" is abbreviated as "HRSPE."

[0091] Example 1 <Heat stimulation by thermal conduction> 1. Before the application of thermal stimulation by thermal conduction, autonomic nerves (parasympathetic and sympathetic nerves) were measured for 5 minutes using the HRSPE described above. 2. Using an ANLAN eye care facial device (ShenZhen Baselab Technology LLC), a thermal stimulus was simultaneously applied to the "ear area" at a temperature of 38°C for 3 minutes. 3. Within 30 minutes after the application of the thermal stimulus, autonomic nerves (parasympathetic and sympathetic nerves) were measured for 5 minutes using the HRSPE described above.

[0092] Example 2 <Vibration stimulation> 1. Before the application of vibration stimulation, autonomic nerves (parasympathetic and sympathetic nerves) were measured for 5 minutes using the HRSPE described above. 2. Using an ANLAN eye care beauty device (manufactured by ShenZhen Baselab Technology LLC), vibration stimulation was simultaneously applied to the aforementioned "ear location" at a temperature of 26°C (room temperature) for 3 minutes with the intensity set to "medium." 3. Within 30 minutes after the application of the vibration stimulus, autonomic nerves (parasympathetic and sympathetic nerves) were measured for 5 minutes using the HRSPE described above.

[0093] Example 3 <Stimulation by infrared radiation (wavelength 940 nm)> 1. Before the application of vibration stimulation, autonomic nerves (parasympathetic and sympathetic nerves) were measured for 5 minutes using the HRSPE described above. 2. Using an infrared night vision IR 940 (manufactured by Stork Corp.), infrared light with a wavelength of 940 nm (0.94 μm) was simultaneously applied to the "ear location" at a temperature of 26° C. (room temperature). 3. Within 30 minutes after the application of the vibration stimulus, autonomic nerves (parasympathetic and sympathetic nerves) were measured for 5 minutes using the HRSPE described above.

[0094] Evaluation example 1 <Measurement items and results> The results of measurements of HRSPE of three subjects before and after the application of stimulation in Examples 1, 2, and 3 are shown in FIGS. As shown in the legend of Figure 6, the "tables, graphs, and explanations for (1) to (8) in Figures 7 to 24" are as follows. In other words, the display locations of the measurement results for (1) to (8) below are as shown in Figure 6.

[0095] <<Measurement items>> (1)Quality Check: The results of checking the information on the measured data (total heart rate / normal heart rate / abnormal heart rate / abnormal heart rate / quality check indicators) were displayed.

[0096] (2)Time Domain Analysis(Time Domain Analysis)・Frequency Domain Analysis(Frequency Domain Analysis) "Norms" displays the average values ​​(healthy values) by age. The range indicated by the horizontal bars in the graph on the right indicates the range of values ​​for healthy subjects, and the ● indicates the position of the value for each subject.

[0097] (3) Autonomic nervous system balance diagram: The balance of the autonomic nervous system and tonus (power / activity level) are displayed as a graph. Vertical axis: autonomic nervous system tone, horizontal axis: autonomic nervous system balance Autonomic nervous system tone: The combination of sympathetic and parasympathetic nervous activity into the overall activity level of the autonomic nervous system. When autonomic nervous tone is low, autonomic nervous function is impaired. Each activity level can be seen in the bar graph (4).

[0098] (4) Indicates the activity level of the sympathetic / parasympathetic nervous system.

[0099] (5) Heart rate graph: The shaded area represents healthy values ​​by age at rest. If it is lower than this, it is bradycardia, if it is higher, it is tachycardia, and if it is within the normal range, it is normal cardiac rhythm.

[0100] (6) Final assessment of autonomic balance: Prevalence rhythm / Heart rhythm disturbances / Autonomic function condition / Recommendations

[0101] (7) Shows the power spectrum (power in each frequency range). VLF: Spectral representation of sympathetic nervous activity and its influence on long-term mechanisms such as hormones and thermoregulation LF: Low frequency, a spectrum reflecting the activity level of the sympathetic nervous system in the frequency band HF: High frequency, spectrum reflecting the activity level and fluctuation of parasympathetic nerves caused by natural breathing in the frequency band (A higher amplitude indicates a higher level of autonomic nervous activity.)

[0102] (8) Scatter plot (heart rate): The shaded area shows the range of average (healthy) values ​​by age.

[0103] <<Definitions and physiological meanings of each index in Figures 7-24 and Tables 2-10>> Table 1 below shows the units, explanations / definitions, and physiological meanings of each index in Figures 7 to 24 and Tables 2 to 10.

[0104] [Table 1]

[0105] <Measurement results and discussion> <<Measurement results>> The measurement results shown in FIGS. 7 to 24 are summarized in Tables 2 to 10 below. Table 2 shows the measurements taken before and after the application of the "heat by thermal conduction" stimulus to subject 1. Table 3 shows the measurements taken before and after the application of the "heat by thermal conduction" stimulus to subject 2. Table 4 shows the measurements taken before and after the application of the "heat by thermal conduction" stimulus to subject 3. Table 5 shows the measurements taken before and after the application of the "vibration" stimulus to subject 1. Table 6 shows the measurements taken before and after the application of the "vibration" stimulus to subject 2. Table 7 shows the measurements taken before and after the application of the "vibration" stimulus to subject 3. Table 8 shows the measurements taken before and after subject 1 was given the "infrared light irradiation" stimulus. Table 9 shows the measurements taken before and after the "infrared light irradiation" stimulus was applied to subject 2. Table 10 shows the measurements taken before and after the "infrared light irradiation" stimulus was applied to subject 3.

[0106] [Table 2]

[0107] [Table 3]

[0108] [Table 4]

[0109] [Table 5]

[0110] [Table 6]

[0111] [Table 7]

[0112] [Table 8]

[0113] [Table 9]

[0114] [Table 10]

[0115] <<Result discussion>> As shown in Figures 7 to 24 and summarized numerically in Tables 2 to 10 above, for some of the indicators listed in Table 1, better results were obtained after stimulation compared to before stimulation, and in particular, a significant increase was observed after stimulation for "HF," which reflects vagal tone. Furthermore, a decrease was observed in the ratio of "LF" (reflecting sympathetic tone) to "HF" (reflecting vagal tone), or "LF / HF." In other words, taking the reciprocal, an increase in "LF" relative to "HF" was observed.

[0116] That is, as shown in Tables 2 to 4, after the thermal stimulation, the "HF" of all three subjects increased significantly compared to before the stimulation. Furthermore, after thermal stimulation, the increase rate of "HF" was greater than that of "LF" before stimulation.

[0117] As shown in Tables 5 to 7, after vibration stimulation, the "HF" of all three subjects increased significantly compared to before stimulation. After vibration stimulation, the increase ratio of "HF" was greater than that of "LF" before stimulation.

[0118] As shown in Tables 8 to 10, after stimulation by infrared light irradiation, "HF" significantly increased compared to before stimulation in two out of three subjects. After stimulation with infrared light, the increase rate of "HF" was greater than that of "LF" in two out of three subjects compared to before stimulation. Furthermore, when the infrared light was replaced with green or red visible light from a visible LED, almost the same results were obtained.

[0119] [Example Group B] Example 4 <Stimulation by infrared radiation (wavelength 810 nm)> Except for the following changes, the subjects were stimulated by infrared light irradiation in the same manner as in Example 3 and Evaluation Example 1 of Example Group A, and the effects of the transcutaneous vagus nerve stimulation device were determined by comparing the measurement results of the parasympathetic nerve, sympathetic nerve, etc. before and after the stimulation.

[0120] <<Changes from Example 3 and Evaluation Example 1>> For the infrared irradiation stimulation, Vielight MIP 633-810 (manufactured by Vielight Inc.) was used, and infrared rays with a wavelength of 810 nm (0.81 μm) were simultaneously applied to the "ear location" at a temperature of 22°C.

[0121] The subjects were five men and women aged 18 to 65, and measurements were taken more than two hours after eating. Subject 4: 52-year-old male Subject 5: 55-year-old woman Subject 6: 33-year-old woman Subject 7: 30-year-old male Subject 8: 33-year-old woman

[0122] <Measurement results and discussion> <<Measurement results>> The measurement results shown in FIGS. 25 to 34 are summarized in the following Tables 11 to 15. Table 11 shows the measurements taken on subject 4 before and after the "infrared light irradiation" stimulus. Table 12 shows the measurements taken before and after subject 5 was given the "infrared light irradiation" stimulus. Table 13 shows the measurements taken on subject 6 before and after the "infrared light irradiation" stimulus. Table 14 shows the measurements taken before and after the "infrared light irradiation" stimulus was applied to subject 7. Table 15 shows the measurements taken before and after the "infrared light irradiation" stimulus was applied to subject 8.

[0123] [Table 11]

[0124] [Table 12]

[0125] [Table 13]

[0126] [Table 14]

[0127] [Table 15]

[0128] Table 16 also shows the rate of change in each parameter for subjects 4 to 8.

[0129] [Table 16]

[0130] <<Result discussion>> The results of HRV tests before and after 810 nm near-infrared irradiation of the auricle-vagus nerve area, including the entrance to the external auditory canal, the cymba concha, and the tragus, showed that the parasympathetic nervous system level improved and that total power (TP), which is the ability to regulate overall autonomic nervous function, also tended to increase. Stimulation of the auricular vagus nerve by near-infrared irradiation at 810 nm can be said to increase HRV, or heart rate variability, and activate the vagus nerve. [Industrial Applicability]

[0131] The transcutaneous vagus nerve stimulation device of the present invention is effective in preventing and treating diseases related to the vagus nerve, and also has various excellent effects, such as providing a sense of relaxation even to healthy people.Therefore, it is widely used not only in the medical field, but also in all fields of manufacturing, sales, and use where vagus nerve stimulation is desired. [Explanation of symbols]

[0132] 10. Transcutaneous vagus nerve stimulation device 11. Thermal stimulation element 11a Peltier element 12 Vibration stimulation element 12a Piezoelectric element 13. Stimulating material using infrared or visible light irradiation 13a Infrared LED or visible LED 20 Earphones 21 In-ear earphones 21a earpiece 21b In-ear type earphone body 21c ear tips (ear pads) 22 In-ear type earphones 22a Diaphragm (vibration plate) 22b Inner ear type earphone body 22c (diaphragm) support 30 headphones 30a diaphragm (vibration plate) 30b Housing 30c (diaphragm) support 40 Earmuffs 40a Earmuff inner surface

Claims

1. A device worn on the ear that transcutaneously stimulates the vagus nerve, A transcutaneous vagus nerve stimulation device, characterized in that the stimulation is infrared light or visible light irradiation, heat by thermal conduction, and / or vibration.

2. The transcutaneous vagus nerve stimulation device according to claim 1 , wherein the "heat generated by thermal conduction" is heat generated from the heat generating surface of a Peltier element.

3. The transcutaneous vagus nerve stimulation device of claim 1 , wherein the vibration is from a piezoelectric element.

4. The transcutaneous vagus nerve stimulation device according to claim 3 , wherein the piezoelectric element is a thin piezoelectric element having a thickness of 3 μm or more and 100 μm or less.

5. The transcutaneous vagus nerve stimulation device according to claim 3 , wherein the “vibration from the piezoelectric element” is vibration with a frequency of 1 Hz or more and 1000 Hz or less.

6. 2. The transcutaneous vagus nerve stimulation device according to claim 1, wherein the infrared light or visible light irradiation is infrared light or visible light irradiation emitted from an infrared LED or a visible LED.

7. 2. The transcutaneous vagus nerve stimulation device according to claim 1, wherein the infrared light or visible light irradiation is near-infrared light irradiation having a wavelength of 780 nm or more and 2500 nm or less.

8. 2. The transcutaneous vagus nerve stimulation device of claim 1, wherein the stimulation is applied to the ear near the external auditory canal, the inner surface of the ear canal, the tragus, the cymba concha, and / or the cavum concha.

9. The transcutaneous vagus nerve stimulation device according to any one of claims 1 to 8, wherein the transcutaneous vagus nerve stimulation device is in the shape of an earphone, a headphone, or an earpiece.

10. The transcutaneous vagus nerve stimulation device of claim 9, further comprising a device for transmitting sound.

11. 3. The transcutaneous vagus nerve stimulation device according to claim 2, wherein the transcutaneous vagus nerve stimulation device is in the form of a canal-type earphone, the Peltier element is installed on the outer surface of the earpiece of the canal-type earphone, and the heat is applied to the inner surface of the ear canal in the ear.

12. The transcutaneous vagus nerve stimulation device according to claim 3, wherein the transcutaneous vagus nerve stimulation device is in the shape of a canal-type earphone, an inner-ear-type earphone, a bone conduction earphone, an ear-hook-type earphone, a headphone, or an earmuff, and the piezoelectric element is installed on the surface or inside of the earphone, the headphone, or the earmuff, so that the vibration is applied to the external auditory canal and / or the pinna of the ear.

13. The transcutaneous vagus nerve stimulation device according to claim 6, wherein the transcutaneous vagus nerve stimulation device is in the shape of a canal-type earphone, an inner-ear-type earphone, a bone conduction earphone, an ear-hook-type earphone, a headphone, or an earmuff, and the infrared LED or visible LED is installed on the surface of the earphone, the headphone, or the earmuff, so that the infrared light or visible light is irradiated onto the ear canal and / or the pinna of the ear.

14. An earphone, a headphone, or an earmuff, comprising the transcutaneous vagus nerve stimulation device according to any one of claims 1 to 8.

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