Method and device for applying electrical stimulation to the vagus nerve that reflects a user's condition and stimulation sensitivity via biological signals
By calculating the SPI index and adjusting the electrical stimulation parameters, combining the individual's demographic and environmental labels, the electrical stimulation parameters are adjusted in real time, and the pain and negative reaction problems caused by differences in the sensitivity of electrical stimulation in the existing technology are solved, achieving personalization and safety of electrical stimulation.
Patent Information
- Application Number
- JP2024560548
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-08-17
- Filing Date
- 2023-05-19
- Publication Date
- 2025-04-30
- Estimated Expiration
- 2043-05-19
AI Technical Summary
In the prior art, when using electrical stimulation to treat the vagus nerve, it is difficult to avoid pain or negative effects caused by differences in individual sensitivity to electrical stimulation and differences in human response.
The initial electrical stimulus values are adjusted by calculating SPI (stimulus perception index), combining individual démographic and environmental labels, and adjusting electrical stimulus parameters in real time through biological signals such as EEG or heart rate variations, ensuring personalization and safety of electrical stimulus.
It effectively avoids pain and negative reactions caused by electrical stimulation, ensures the safety and personalized effect of electrical stimulation, and improves the effectiveness of treatment and user comfort.
Smart Images

Figure 2025513866000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to a method and apparatus for applying electrical stimulation to the vagus nerve, and more particularly to a method and apparatus for applying electrical stimulation to the vagus nerve via electrodes in contact with the skin of the human body. [Background technology]
[0002] The vagus nerve is one of the cranial nerves and is the 10th cranial nerve. It is a mixed nerve that includes parasympathetic nerve fibers and is distributed from the brain to the face, chest, and abdomen, and is involved in regulating the parasympathetic nerves that act on the heart, lungs, digestive tract, etc. It has the longest and most complex structure of the 12 pairs of cranial nerves, and includes both sensory and motor nerve fibers.
[0003] It is known that vagus nerve stimulators for epilepsy and depression treatment have been approved by the U.S. Food and Drug Administration (FDA), and these stimulate the cervical branch located in the neck. However, this type of cervical branch electrical stimulation of the vagus nerve requires making an incision directly in the skin to expose the cervical branch of the vagus nerve, and then winding a coil, which is an electrical element, on the outside of the branch and attaching a microchip, so it cannot be used for self-treatment by the general public.
[0004] Meanwhile, in traditional Chinese medicine, a method of treating illnesses is applied through acupuncture treatment of the ear. The ear is where the auricular branch of the vagus nerve is distributed, and is thought to be used for stimulating treatment of the vagus nerve.
[0005] For this reason, devices have been developed that electrically stimulate the vagus nerve in the ear in order to alleviate symptoms, but these devices are not widely used because the desired effect cannot be obtained during use due to differences in individual sensitivity to electrical stimulation and differences in human body reactions. Summary of the Invention [Problem to be solved by the invention]
[0006] The present invention is intended to solve the problems of the prior art described above, and its purpose is to provide a method and device for applying electrical stimulation to the vagus nerve, which reflects the user's sensitivity to electrical stimulation and the state of the human body during the application of stimulation, and is free of problems caused by pain or negative effects. [Means for solving the problem]
[0007] In order to achieve the above object, a method for applying electrical stimulation to the vagus nerve according to the present invention is a method for applying electrical stimulation to the vagus nerve through an electrode that contacts the skin of a human body, and includes an electrical stimulation guideline input step of inputting an electrical stimulation guideline including a numerical value for the electrical stimulation, an initial stimulation value setting step of deriving an initial stimulation value by adjusting the numerical value included in the electrical stimulation guideline by applying an SPI calculated by applying one or more of a demographic indicator and an environmental indicator before applying the electrical stimulation, an electrical stimulation start step of applying the electrical stimulation at the initial stimulation value, and a stimulation during adjustment step of measuring the user's biosignal while the electrical stimulation is applied to the user and adjusting the electrical stimulation applied to the electrode, wherein the SPI is an index that quantifies sensitivity to electrical stimulation, the demographic indicator is an indicator that statistically reflects the degree of sensitivity to electrical stimulation, and the environmental indicator is an indicator that reflects environmental factors that affect the sensitivity to electrical stimulation.
[0008] The demographic indicators may include one or more of the following: age, sex, BMI, medication status, and disease status.
[0009] The environmental indicators may include one or more of the following information: temperature, humidity, light intensity, and discomfort index.
[0010] In the initial stimulation value setting step, if the SPI is below a predetermined value, it is preferable to not change the input electrical stimulation guideline, and if the SPI exceeds the predetermined value, to change the electrical stimulation guideline in proportion to the excess value of the SPI.
[0011] The electrical stimulation guideline includes information about current and duty ratio, and in the initial stimulation value setting step, the current of the electrical stimulation guideline can be reduced and the duty ratio can be increased in proportion to the excess value of the SPI.
[0012] The user's biological signal measured in the stimulation adjustment step is preferably an electroencephalogram or a heart rate variability.
[0013] In the case of using electroencephalograms, the stimulation adjustment step adjusts the electrical stimulation applied to the electrodes by applying a change in FSWR calculated by measuring the user's electroencephalogram while an electrical stimulation is applied to the user, and the change in FSWR is intended to confirm the effect of the electrical stimulation applied to the user on the human body. It is preferable that the FSWR is calculated by dividing the power of a fast wave band having a relatively high frequency in the measured electroencephalogram by the power of a slow wave band having a relatively low frequency.
[0014] It is preferable that the fast wave band is brain waves exceeding 13 Hz, and the slow wave band is brain waves below 13 Hz.
[0015] The change in FSWR was measured before or immediately after the application of electrical stimulation. 0 From the above, the FSWR measured after the electrical stimulation was applied N It is preferable to use a rate of change in FSWR, which is the rate at which the electrical stimulation is changed to the electrical stimulation voltage, and adjust the electrical stimulation applied through the electrodes when the rate of change in FSWR is greater than a predetermined value.
[0016] When the FSWR rate of change is greater than a predetermined value, it is preferable to reduce the current of the electrical stimulation applied via the electrodes and increase the duty cycle.
[0017] When the FSWR change rate increases by 50% or more, the electrical stimulation current can be reduced to the range of 10 to 30%, and the duty ratio can be increased to the range of 10 to 45%.
[0018] When heart rate variability is used, the during-stimulation adjustment step adjusts the electrical stimulation applied to the electrodes by applying a change in FSBR calculated by measuring the user's heart rate variability while an electrical stimulation is applied to the user, and the change in FSBR is intended to confirm the effect of the electrical stimulation applied to the user on the human body, and it is preferable that the FSBR is calculated by dividing the power of a high-frequency band, which has a relatively high frequency, in the measured heart rate variability, by the power of a low-frequency band, which has a relatively low frequency.
[0019] It is preferable that the high frequency band is in the range of 0.15 Hz to 0.4 Hz, and the low frequency band is in the range of 0.04 Hz to less than 0.15 Hz.
[0020] The change in FSBR was measured before or immediately after the application of electrical stimulation. 0 From the above, the FSBR measured after the electrical stimulation was applied N It is preferable to use a FSBR change rate, which is the rate at which the FSBR changes, and adjust the electrical stimulation applied via the electrodes when the FSBR change rate is greater than a predetermined value.
[0021] When the FSBR change rate is greater than a predetermined value, it is preferable to reduce the current of the electrical stimulation applied via the electrodes and increase the duty ratio.
[0022] When the FSBR change rate increases by 50% or more, the electrical stimulation current can be reduced to the range of 10 to 30%, and the duty ratio can be increased to the range of 10 to 45%.
[0023] According to another aspect of the present invention, a device for applying electrical stimulation to a vagus nerve includes electrodes that contact the skin of a human body to apply electrical stimulation; an input unit that receives an input of an electrical stimulation guideline including numerical information for the electrical stimulation; an initial stimulation value setting unit that derives an initial stimulation value by adjusting a numerical value included in the electrical stimulation guideline by applying an SPI calculated by applying one or more of a demographic indicator and an environmental indicator before applying the electrical stimulation; and a mid-stimulation adjustment unit that measures a user's biological signal while the electrical stimulation is being applied to the user and adjusts the electrical stimulation applied to the electrodes, wherein the SPI is an index that quantifies sensitivity to electrical stimulation, the demographic indicator is an indicator that statistically reflects the degree of sensitivity to electrical stimulation, and the environmental indicator is an indicator that reflects environmental factors that affect the sensitivity to electrical stimulation.
[0024] The demographic indicators may include one or more of the following: age, sex, BMI, medication status, and disease status.
[0025] The environmental indicators may include one or more of the following information: temperature, humidity, light intensity, and discomfort index.
[0026] It is preferable that the initial stimulation value setting unit does not change the input electrical stimulation guideline when the SPI is below a predetermined value, and changes the electrical stimulation guideline in proportion to the excess value of the SPI when the SPI exceeds the predetermined value.
[0027] The electrical stimulation guideline includes information on current and duty ratio, and in the initial stimulation value setting step, the current of the electrical stimulation guideline can be reduced and the duty ratio can be increased in proportion to the excess value of the SPI.
[0028] The biosignal of the user measured by the stimulation adjustment unit is preferably an electroencephalogram or a heart rate variability.
[0029] When brain waves are used, the stimulation adjustment unit adjusts the electrical stimulation applied to the electrodes by applying a change in FSWR calculated by measuring the user's brain waves while an electrical stimulation is applied to the user, and the change in FSWR is intended to confirm the effect of the electrical stimulation applied to the user on the human body, and it is preferable that the FSWR is calculated by dividing the power of a fast wave band, which has a relatively high frequency, by the power of a slow wave band, which has a relatively low frequency, in the measured brain waves.
[0030] It is preferable that the fast wave band is brain waves exceeding 13 Hz, and the slow wave band is brain waves below 13 Hz.
[0031] The change in FSWR was measured before or immediately after the application of electrical stimulation. 0 From the above, the FSWR measured after the electrical stimulus was applied N It is preferable to use a rate of change in FSWR, which is the rate at which the electrical stimulation is changed to the electrical stimulation voltage, and adjust the electrical stimulation applied through the electrodes when the rate of change in FSWR is greater than a predetermined value.
[0032] When the FSWR rate of change is greater than a predetermined value, it is preferable to reduce the current of the electrical stimulation applied via the electrodes and increase the duty cycle.
[0033] When the FSWR change rate increases by 50% or more, the electrical stimulation current can be reduced to the range of 10 to 30%, and the duty ratio can be increased to the range of 10 to 45%.
[0034] When heart rate variability is used, the stimulation adjustment unit adjusts the electrical stimulation applied to the electrodes by applying a change in FSBR calculated by measuring the user's heart rate variability while an electrical stimulation is applied to the user, and the change in FSBR is intended to confirm the effect of the electrical stimulation applied to the user on the human body, and it is preferable that the FSBR is calculated by dividing the power of a high-frequency band, which has a relatively high frequency, by the power of a low-frequency band, which has a relatively low frequency, in the measured heart rate variability.
[0035] It is preferable that the high frequency band is in the range of 0.15 Hz to 0.4 Hz, and the low frequency band is in the range of 0.04 Hz to less than 0.15 Hz.
[0036] The change in FSWR was calculated based on the FSBR measured before or immediately after the application of electrical stimulation. 0 From the above, the FSBR measured after the electrical stimulation was applied N It is preferable to use a FSBR change rate, which is the rate at which the FSBR changes, and adjust the electrical stimulation applied via the electrodes when the FSBR change rate is greater than a predetermined value.
[0037] When the FSBR change rate is greater than a predetermined value, it is preferable to reduce the current of the electrical stimulation applied via the electrodes and increase the duty ratio.
[0038] When the FSBR change rate increases by 50% or more, the electrical stimulation current can be reduced to the range of 10 to 30%, and the duty ratio can be increased to the range of 10 to 45%. Effect of the Invention
[0039] The present invention configured as described above has an advantage in that it is possible to prevent a user from feeling pain due to electrical stimulation by applying electrical stimulation in a manner that reflects the user's sensitivity to electrical stimulation.
[0040] In addition, by applying electrical stimulation reflecting the user's state via brain waves, it is possible to prevent problems with the application of electrical stimulation that has a negative effect on the user. [Brief description of the drawings]
[0041] [Figure 1] 4 is a flowchart illustrating a method for applying electrical stimulation to the vagus nerve, reflecting a user's state and stimulation sensitivity through a biosignal, according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0042] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
[0043] However, the embodiments of the present invention can be modified into various other forms, and the scope of the present invention is not limited to only the embodiments described below. The shapes and sizes of elements in the drawings may be exaggerated for clearer explanation, and elements represented by the same reference numerals in the drawings are the same elements.
[0044] In addition, throughout the specification, when a part is described as being "connected" to another part, this includes not only the case where the part is "directly connected" to another part, but also the case where the part is "electrically connected" to another part via another element therebetween. In addition, when a part is described as "including" or "comprising" a certain component, this means that the part can further include or comprise the other component, rather than excluding the other component, unless otherwise specified to the contrary.
[0045] In addition, terms such as "first" and "second" are used to distinguish one component from another, and should not be used to limit the scope of rights. For example, the first component can be named the second component, and similarly, the second component can be named the first component.
[0046] FIG. 1 is a flow chart illustrating a method for applying electrical stimulation to the vagus nerve, reflecting a user's condition and stimulation sensitivity through a biosignal, according to the present invention.
[0047] In the method of applying electrical stimulation to the vagus nerve according to this embodiment, first, an electrical stimulation guideline input step is performed.
[0048] The electrical stimulation guideline includes information about electrical stimulation for vagus nerve stimulation. The electrical stimulation guideline may be determined by a doctor's diagnosis and prescription at a hospital, or may be derived through a separate program or system. In this case, the electrical stimulation guideline may be determined according to a user's illness or symptoms, and may not reflect the user's characteristics. Therefore, the electrical stimulation included in the electrical stimulation guideline may cause pain to the user depending on the user's sensitivity to electrical stimulation.
[0049] The electrical stimulation guideline for vagus nerve stimulation may include information such as electrical stimulation current, frequency, duty ratio, and stimulation time. In this manner, the electrical stimulation guideline including information on the predetermined electrical stimulation is inputted through an input unit of the device for applying electrical stimulation to the vagus nerve. The method of inputting the electrical stimulation guideline may be that the information on the electrical stimulation is directly inputted by a user, or may be automatically inputted through a code (barcode or QR code) including the information on the electrical stimulation or an information storage device.
[0050] Next, an initial stimulus value setting step is performed.
[0051] The initial stimulation value is a value that reflects the sensitivity to electrical stimulation and sets the electrical stimulation guideline to an appropriate range of electrical stimulation for the user. Sensitivity to electrical stimulation is a concept based on the fact that pain or discomfort from the same electrical stimulation varies from person to person, and means the degree to which pain or discomfort can be easily felt from electrical stimulation. In the present invention, sensitivity to electrical stimulation reflects not only the sensitivity according to the strength of physical stimulation and the sensitivity that a person recognizes as pain, but also the sensitivity to feeling psychological and emotional discomfort or anxiety without feeling pain. If the sensitivity to electrical stimulation is high, the probability of feeling pain or discomfort from the same electrical stimulation is high, and in particular, as the current increases, greater pain or discomfort is felt.
[0052] The present invention applies the Stimulation Perception Index (SPI) as an index that quantifies the sensitivity to electrical stimulation. The SPI of the present invention is calculated by applying demographic indicators and / or environmental indicators. The demographic indicators are indicators that statistically represent the sensitivity to electrical stimulation based on biological information such as age, sex, BMI (body mass index), whether or not one is taking medication, and whether or not one has a disease. For example, children or elderly people are more sensitive to electrical stimulation than young and middle-aged people, women are more sensitive to electrical stimulation than men, and the higher the BMI, the lower the sensitivity to electrical stimulation. The demographic indicators are statistically organized information such as this information that can be applied to the SPI index. The environmental indicators are indicators that statistically represent the sensitivity to electrical stimulation based on surrounding environmental information such as temperature, humidity, illuminance, and discomfort index. For example, when the temperature or humidity is lower than a certain value, the sensitivity to electrical stimulation increases, and when the illuminance is lower, the sensitivity to electrical stimulation increases, and the discomfort index has different sensitivity to electrical stimulation depending on the range. When the sensitivity to electrical stimulation indicated by the SPI index is high, it is the case that the user is likely to feel pain or discomfort from electrical stimulation. Therefore, it is preferable to set the initial stimulation value in a direction to reduce the degree of stimulation so that the user does not feel pain or discomfort, for example, by reducing the intensity of the current. However, the electrical stimulation guideline is provided with a value that can obtain a predetermined effect, and if the intensity of the current is simply reduced, the effect of the application of electrical stimulation may not be obtained because sufficient stimulation is not applied. Therefore, compensation is required to reduce the current, and a method of increasing the duty ratio in proportion to the reduction in the current can be applied. It is preferable not to change the frequency of the electrical stimulation guideline, and since the user's discomfort increases as the time for applying electrical stimulation increases, it is preferable to maintain the electrical stimulation application time as well. In this case, it is evaluated that the user is sensitive to electrical stimulation only when the SPI index is greater than a predetermined value, and the initial stimulation value can be set in a direction to reduce the current and increase the duty ratio in proportion to the value that exceeds the predetermined value. Conversely, if the SPI index is equal to or less than a predetermined value, the current and duty ratio of the input electrical stimulation guideline can be applied as the initial stimulation value as they are.In this way, the process of deriving the initial stimulation value from the input electrical stimulation guideline is performed by the initial stimulation value setting unit, which may include a DB for deriving the SPI index, an input device for receiving input of age and gender to apply demographic indicators, and a BMI measuring device for directly measuring and applying BMI. Furthermore, it may include an input device for receiving input of information to apply environmental indicators, and may include a thermometer or hygrometer for directly measuring and reflecting temperature and humidity.
[0053] In addition, an electrical stimulation initiation step is performed in which an initial stimulation value derived using the SPI index is applied to the electrodes.
[0054] The present invention then performs a mid-stimulation adjustment step in which the electrical stimulation applied to the electrodes is adjusted rather than simply maintaining the initial stimulation value unchanged.
[0055] Although the initial stimulation value of the present invention reflects the sensitivity to electrical stimulation, as the electrical stimulation continues, it may have a negative effect on the human body. As described above, the effect on the human body may be directly recognized by the user in the form of pain, but may also be expressed in psychological or emotional forms such as discomfort or anxiety. If the user continues to receive electrical stimulation while enduring pain, or continues to receive electrical stimulation while feeling discomfort or anxiety, the positive effects such as symptom relief or stress relief that are intended to be obtained through electrical stimulation may not be obtained, and conversely, negative results such as worsening of symptoms or increased stress may be obtained.
[0056] Therefore, in the first embodiment of the present invention, a stimulation adjustment step is performed in which the electrical stimulation applied to the electrodes is adjusted by applying the amount of change in FSWR calculated by measuring the user's brain waves as information for confirming the effect of the electrical stimulation on the human body.
[0057] The FSWR (Fast-to-Slow Wave Ratio) applied in this embodiment is a value calculated by dividing the power of the fast wave band, which has a relatively high frequency, by the power of the slow wave band, which has a relatively low frequency, in the electroencephalogram measured while electrical stimulation is applied, and was developed for the purpose of checking the state of the user in response to electrical stimulation that causes the user to feel pain, discomfort, or anxiety through the amount of change. In this case, the fast wave band is electroencephalograms exceeding 13 Hz, and the slow wave band is electroencephalograms below 13 Hz. Specifically, in order to apply the amount of change in FSWR, the FSWR derived from the electroencephalogram measured before or immediately after the application of electrical stimulation is 0 FSWR derived from the EEG measured after electrical stimulation was applied N The FSWR change rate, which is the rate at which the electrical stimulation has changed to the normal state, is applied. If the FSWR change rate is greater than a predetermined value, it indicates that the electrical stimulation has caused a negative state in the user, even if the user does not directly feel pain, and the magnitude of the current applied to the electrode is reduced accordingly. In this case, if the intensity of the current is reduced, the effect of the application of the electrical stimulation may not be obtained because a sufficient stimulation is not applied. Therefore, compensation is required for the amount of current reduction, and a method of increasing the duty ratio in proportion to the reduction in current can be applied. It is preferable that the frequency of the electrical stimulation guideline is not changed, and since an increase in the time for applying the electrical stimulation increases the discomfort of the user, it is preferable that the application time of the electrical stimulation is also maintained. Specifically, when the FSWR change rate increases by 50% or more, the stimulation adjustment step can be performed by reducing the electrical stimulation current to a range of 10 to 30% and increasing the duty ratio to a range of 10 to 45%. Such a during-stimulation adjustment step is performed by an during-stimulation adjustment unit, which may include an electroencephalogram measuring device for measuring electroencephalograms to derive the FSWR change rate, a memory device for storing electroencephalogram data and deriving the FSWR and its change rate, and may include a control device for adjusting the electrical stimulation applied to the electrodes to reflect the FSWR change rate.
[0058] In addition, in the second embodiment of the present invention, a stimulation adjustment step is performed in which the electrical stimulation applied to the electrodes is adjusted by applying the amount of change in FSBR calculated by measuring the user's heart rate variability as information for confirming the effect of the electrical stimulation on the human body. Heart rate variability, which means the degree of variation in heart rate, means minute variations from one cardiac cycle to the next cardiac cycle. Meanwhile, pulses reflect the characteristics of heart rate, although there is a difference in the measurement position, and therefore can be used as the same as heart rate or as a substitute for heart rate. Therefore, in the following, pulse rate variability can be treated as a substitute for heart rate variability or approximately the same, and in this case, the part corresponding to the measurement of heart rate variability can be replaced by the measurement of pulse rate variability.
[0059] The FSBR (Fast-to-Slow Beat Ratio) applied in this embodiment is a value calculated by dividing the power of a high-frequency band with a relatively high frequency by the power of a low-frequency band with a relatively low frequency in the heart rate variability measured while electrical stimulation is applied, and was developed for the purpose of checking the state of the user in response to electrical stimulation that causes the user to feel pain, discomfort, or anxiety through the amount of change. In this case, the high-frequency band is in the range of 0.15 Hz to 0.4 Hz, and the low-frequency band is in the range of 0.04 Hz to less than 0.15 Hz. Specifically, in order to apply the amount of change in FSBR, the FSBR derived from the heart rate variability measured before or immediately after the application of electrical stimulation is 0 FSBR derived from the heart rate variability measured after electrical stimulation was applied. NThe FSBR change rate, which is the rate at which the electrical stimulation has changed to the normal state, is applied. If the FSBR change rate is greater than a predetermined value, it indicates that the electrical stimulation has caused a negative state in the user, even if the user does not directly feel pain, and therefore the magnitude of the current applied to the electrodes is reduced. At this time, if the intensity of the current is reduced, the effect of the application of the electrical stimulation may not be obtained because a sufficient stimulation is not applied. Therefore, compensation is required for the amount of current reduction, and a method of increasing the duty ratio in proportion to the reduction in current can be applied. It is preferable not to change the frequency of the electrical stimulation guideline, and since an increase in the time for applying the electrical stimulation increases the discomfort of the user, it is preferable to maintain the application time of the electrical stimulation. Specifically, when the FSBR change rate increases by 50% or more, the stimulation adjustment step can be performed by reducing the electrical stimulation current to a range of 10 to 30% and increasing the duty ratio to a range of 10 to 45%. Such an adjustment step during stimulation is performed by an adjustment unit during stimulation, which may include an electrocardiogram measuring device that measures heart rate variability to derive the FSBR change rate, a storage device that stores the electrocardiogram data and derives the FSBR and its change rate, and may include a control device that adjusts the electrical stimulation applied to the electrodes in accordance with the FSBR change rate.
[0060] Although the present invention has been described above through preferred embodiments, the above-mentioned embodiments are merely illustrative of the technical idea of the present invention, and it will be understood by those of ordinary skill in the art that various changes are possible within the scope of the technical idea of the present invention. Therefore, the scope of protection of the present invention should be interpreted not by specific embodiments but by the matters described in the claims, and all technical ideas within the scope equivalent thereto should be interpreted as being included in the scope of the present invention.
Claims
1. 1. A method for applying electrical stimulation to the vagus nerve via an electrode in contact with the skin of a human body, comprising: An electrical stimulation guideline input step of inputting an electrical stimulation guideline including a numerical value for the electrical stimulation; An initial stimulation value setting step of deriving an initial stimulation value by adjusting a numerical value included in the electrical stimulation guideline by applying an SPI calculated by applying one or more of demographic indicators and environmental indicators before applying the electrical stimulation; an electrical stimulation initiation step of applying electrical stimulation at an initial stimulation value; and a stimulation adjustment step of measuring a biosignal of the user while the electrical stimulation is being applied to the user and adjusting the electrical stimulation applied to the electrodes. A method for applying electrical stimulation to the vagus nerve, characterized in that the SPI is an index that quantifies sensitivity to electrical stimulation, the demographic indicator is an indicator that statistically reflects the degree of sensitivity to electrical stimulation, and the environmental indicator is an indicator that reflects environmental factors that affect the sensitivity to electrical stimulation.
2. The method of claim 1 , wherein the demographic indicators include one or more of the following information: age, sex, BMI, whether or not the subject is taking medication, and whether or not the subject has a disease.
3. The method of claim 1 , wherein the environmental indicators include one or more of the following information: temperature, humidity, illuminance, and discomfort index.
4. In the initial stimulus value setting step, If the SPI is equal to or less than a predetermined value, the input electrical stimulation guideline is not changed, 2. The method of claim 1, further comprising the step of: changing the electrical stimulation guideline in proportion to the excess value of the SPI when the SPI exceeds a predetermined value.
5. The electrical stimulation guideline includes information regarding current and duty ratio; 5. The method for applying electrical stimulation to the vagus nerve according to claim 4, wherein in the initial stimulation value setting step, the current of the electrical stimulation guide is decreased and the duty ratio is increased in proportion to the excess value of the SPI.
6. 2. The method for applying electrical stimulation to the vagus nerve according to claim 1, wherein the biosignal of the user measured in the stimulation adjustment step is an electroencephalogram or a heart rate variability.
7. The step of adjusting during stimulation includes: By applying a change in FSWR calculated by measuring the user's brain waves while the electrical stimulation is applied to the user, the electrical stimulation applied to the electrodes is adjusted; 7. The method of claim 6, wherein the change in FSWR is for checking an effect of the electrical stimulation applied to the user on the human body, and the FSWR is calculated by dividing the power of a fast wave band having a relatively high frequency in the measured electroencephalogram by the power of a slow wave band having a relatively low frequency.
8. 7. The method of claim 6, wherein the fast wave band is an electroencephalogram exceeding 13 Hz, and the slow wave band is an electroencephalogram below 13 Hz.
9. The change in FSWR is the FSWR measured before or immediately after the application of the electrical stimulus. 0 From the FSWR measured after the electrical stimulus was applied, N Using the FSWR change rate, which is the rate at which the 7. The method of claim 6, further comprising adjusting the electrical stimulation applied via the electrodes when the rate of change of FSWR is greater than a predetermined value.
10. 10. The method for applying electrical stimulation to the vagus nerve according to claim 9, further comprising the steps of: reducing the current of the electrical stimulation applied via the electrodes and increasing the duty ratio when the FSWR change rate is greater than a predetermined value.
11. The method for applying electrical stimulation to the vagus nerve as described in claim 10, characterized in that when the FSWR change rate increases by 50% or more, the electrical stimulation current is reduced to a range of 10 to 30% and the duty ratio is increased to a range of 10 to 45%.
12. The step of adjusting during stimulation includes: adjusting the electrical stimulation applied to the electrodes by applying a change in FSBR calculated by measuring the user's heart rate variability while the electrical stimulation is applied to the user; 7. The method for applying electrical stimulation to the vagus nerve of claim 6, wherein the change in FSBR is for confirming an effect of the electrical stimulation applied to the user on the human body, and the FSBR is calculated by dividing the power of a high-frequency band having a relatively high frequency in the measured heart rate variability by the power of a low-frequency band having a relatively low frequency.
13. 13. The method for applying electrical stimulation to the vagus nerve according to claim 12, wherein the high frequency band is in the range of 0.15 Hz to 0.4 Hz, and the low frequency band is in the range of 0.04 Hz to less than 0.15 Hz.
14. The change in FSBR was calculated by dividing the FSBR measured before or immediately after the application of electrical stimulation. 0 From the FSBR measured after the electrical stimulus was applied, N Using the FSBR change rate, which is the rate at which the 13. The method of claim 12, further comprising adjusting the electrical stimulation applied via the electrodes when the rate of change of FSBR is greater than a predetermined value.
15. 15. The method for applying electrical stimulation to the vagus nerve according to claim 14, characterized in that, when the rate of change of FSBR is greater than a predetermined value, the current of the electrical stimulation applied via the electrodes is reduced and the duty ratio is increased.
16. 16. The method for applying electrical stimulation to the vagus nerve according to claim 15, characterized in that, when the FSBR change rate increases by 50% or more, the electrical stimulation current is reduced to a range of 10 to 30% and the duty ratio is increased to a range of 10 to 45%.
17. An electrode that contacts the skin of a human body to apply electrical stimulation; an input unit for receiving an input of an electrical stimulation guideline including numerical information for the electrical stimulation; An initial stimulation value setting unit that derives an initial stimulation value by adjusting a numerical value included in the electrical stimulation guideline by applying an SPI calculated by applying one or more of a demographic indicator and an environmental indicator before applying the electrical stimulation; and a stimulation adjustment unit that measures a biosignal of a user while an electrical stimulus is being applied to the user and adjusts the electrical stimulus applied to the electrodes, A device for applying electrical stimulation to the vagus nerve, characterized in that the SPI is an index that quantifies sensitivity to electrical stimulation, the demographic indicator is an indicator that statistically reflects the degree of sensitivity to electrical stimulation, and the environmental indicator is an indicator that reflects environmental factors that affect sensitivity to electrical stimulation.
18. The device for applying electrical stimulation to the vagus nerve according to claim 17, wherein the demographic indicators include one or more of the following information: age, sex, BMI, whether or not the user is taking medication, and whether or not the user has a disease.
19. 18. The device for applying electrical stimulation to the vagus nerve according to claim 17, wherein the environmental indicator includes one or more pieces of information of temperature, humidity, illuminance, and discomfort index.
20. The initial stimulus value setting unit, If the SPI is equal to or less than a predetermined value, the input electrical stimulation guideline is not changed, 18. The device for applying electrical stimulation to the vagus nerve according to claim 17, wherein, when the SPI exceeds a predetermined value, the electrical stimulation guideline is changed in proportion to the excess value of the SPI.
21. The electrical stimulation guideline includes information regarding current and duty ratio; 21. The device for applying electrical stimulation to the vagus nerve according to claim 20, wherein the initial stimulation value setting unit reduces the current of the electrical stimulation guideline and increases the duty ratio in proportion to the excess value of the SPI.
22. The device for applying electrical stimulation to the vagus nerve according to claim 20 , wherein the biosignal of the user measured by the stimulation adjustment unit is an electroencephalogram or a heart rate variability.
23. The stimulation adjustment unit is By applying a change in FSWR calculated by measuring the user's brain waves while the electrical stimulation is applied to the user, the electrical stimulation applied to the electrodes is adjusted; 23. The device for applying electrical stimulation to the vagus nerve of claim 22, wherein the change in FSWR is for checking an effect of the electrical stimulation applied to the user on the human body, and the FSWR is calculated by dividing the power of a fast wave band having a relatively high frequency in a measured electroencephalogram by the power of a slow wave band having a relatively low frequency.
24. 24. The device for applying electrical stimulation to the vagus nerve according to claim 23, wherein the fast wave band is an electroencephalogram exceeding 13 Hz, and the slow wave band is an electroencephalogram below 13 Hz.
25. The change in FSWR is the FSWR measured before or immediately after the application of the electrical stimulus. 0 From the FSWR measured after the electrical stimulus was applied, N Using the FSWR change rate, which is the rate at which the 24. The device for applying electrical stimulation to the vagus nerve according to claim 23, further comprising: adjusting the electrical stimulation applied via the electrodes when the rate of change of FSWR is greater than a predetermined value.
26. 26. The device for applying electrical stimulation to the vagus nerve according to claim 25, wherein when the rate of change of FSWR is greater than a predetermined value, the current of the electrical stimulation applied via the electrodes is reduced and the duty ratio is increased.
27. 27. The device for applying electrical stimulation to the vagus nerve as described in claim 26, characterized in that when the FSWR change rate increases by 50% or more, the electrical stimulation current is reduced to a range of 10 to 30% and the duty ratio is increased to a range of 10 to 45%.
28. The stimulation adjustment unit is adjusting the electrical stimulation applied to the electrodes by applying a change in FSBR calculated by measuring the user's heart rate variability while the electrical stimulation is applied to the user; 23. The device for applying electrical stimulation to the vagus nerve as described in claim 22, wherein the change in FSBR is for confirming an effect of the electrical stimulation applied to the user on the human body, and the FSBR is calculated by dividing the power of a high-frequency band having a relatively high frequency in the measured heart rate variability by the power of a low-frequency band having a relatively low frequency.
29. 29. The device for applying electrical stimulation to the vagus nerve according to claim 28, wherein the high frequency band is in the range of 0.15 Hz or more and 0.4 Hz or less, and the low frequency band is in the range of 0.04 Hz or more and less than 0.15 Hz.
30. The change in FSWR is the FSBR measured before or immediately after the application of electrical stimulation. 0 From the FSBR measured after the electrical stimulus was applied, N Using the FSBR change rate, which is the rate at which the 29. The device for applying electrical stimulation to the vagus nerve according to claim 28, characterized in that the electrical stimulation applied via the electrodes is adjusted when the rate of change of FSBR is greater than a predetermined value.
31. 31. The device for applying electrical stimulation to the vagus nerve according to claim 30, wherein when the rate of change of FSBR is greater than a predetermined value, the current of the electrical stimulation applied via the electrodes is reduced and the duty ratio is increased.
32. 32. The device for applying electrical stimulation to the vagus nerve as described in claim 31, characterized in that when the FSBR change rate increases by 50% or more, the electrical stimulation current is reduced to a range of 10 to 30% and the duty ratio is increased to a range of 10 to 45%.
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