Vagus nerve stimulation device

Abstract

The present invention relates to a vagus nerve stimulation device. The vagus nerve stimulation device includes: a stimulation unit including an electrode worn on at least one of the left ear and the right ear to apply electrical stimulation to the vagus nerve of the external ear; a control unit for transmitting, to the stimulation unit, an electrical stimulation signal for generating electrical stimulation; and a mode selection unit through which a user selects a stimulation mode, wherein the mode selection unit includes a plurality of preset modes, each including an electrical stimulation signal that includes a stimulation pattern constituting the frequency of a stimulation pulse and the application type of a stimulation, the control unit stores information on an electrical stimulation signal corresponding to each mode and transmits the electrical stimulation signal corresponding to a mode selected by a user to the stimulation unit, and the mode selection unit includes a tension relaxation mode, a concentration mode, and a sleep induction mode. The present invention has a plurality of operation modes specialized for a specific purpose, thereby improving the effect of electrical stimulation through a mode selected according to the user's use purpose.

Description

vagus nerve stimulator

[0001] The present invention relates to a device for stimulating the vagus nerve, and more particularly, to a vagus nerve stimulator capable of applying various modes.

[0002] The vagus nerve, commonly referred to as the tenth cranial nerve, originates from the brain and extends across the face, chest, and abdomen. As a mixed nerve containing parasympathetic fibers, it regulates the parasympathetic nervous system, which affects the heart, lungs, and digestive tract. It is the longest and most complex of the twelve pairs of cranial nerves, containing both sensory and motor fibers.

[0003] Vagus nerve stimulation devices for the treatment of epilepsy and depression have reportedly been approved by the U.S. Food and Drug Administration (FDA). These devices target the cervical branches of the vagus nerve. However, this cervical branch electrical stimulation procedure involves making a direct incision in the skin to expose the cervical branches of the vagus nerve. This procedure involves wrapping an electromechanical coil around the cervical branches and implanting a microchip, making it inappropriate for self-treatment by the general public.

[0004] Meanwhile, the human ear is a major pathway for the vagus nerve, and because the nerve is located close to the skin, it is considered a suitable site for external electrical stimulation. In Oriental medicine, acupuncture is used to treat diseases. Since the ear is where the auricular branch of the vagus nerve is distributed, stimulation of the vagus nerve can be considered a therapeutic approach. However, the use of acupuncture poses a challenge for the general public.

[0005] Accordingly, vagus nerve stimulation devices that apply electrical stimulation by contacting the ear with electrodes have been developed and are being developed, but the specific form of stimulation applied to these vagus nerve stimulation devices is limited.

[0006] The present invention is intended to solve the problems of the above-mentioned prior art and to provide a vagus nerve stimulation device that can apply various modes.

[0007] In order to achieve the above object, the vagus nerve stimulation device according to the present invention comprises: a stimulation unit including an electrode that is worn on at least one of the left and right ears and applies electrical stimulation to the vagus nerve of the external ear; a control unit that transmits an electrical stimulation signal for generating electrical stimulation to the stimulation unit; and a mode selection unit that allows a user to select a mode of stimulation, wherein the mode selection unit includes a plurality of modes in which an electrical stimulation signal including a stimulation pattern constituting a frequency of a stimulation pulse and an application form of the stimulation is preset, the control unit stores information on the electrical stimulation signal corresponding to each mode and transmits an electrical stimulation signal corresponding to a mode selected by the user to the stimulation unit, and the mode selection unit is characterized in that it includes a relaxation mode, a concentration mode, and a sleep induction mode.

[0008] The above-mentioned tension relaxation mode has a stimulation pattern that continuously applies a stimulation pulse of 10 to 30 Hz for a predetermined period of time.

[0009] The above-mentioned focused mode has a stimulation pattern in which a stimulation pulse of 25 to 40 Hz is sequentially applied in an ON state where stimulation is applied and an OFF state where stimulation is not applied, and it is preferable that the length of each of the ON state and OFF state is 1 to 2 seconds.

[0010] The above sleep induction mode has a stimulation pattern in which a HIGH state in which a relatively strong stimulus is applied and a LOW state in which a relatively weak stimulus is applied are sequentially applied with a stimulation pulse of 1 to 10 Hz, and it is preferable that the stimulation intensity of the LOW state is 30 to 60% of the stimulation intensity of the HIGH state, and the length of each of the HIGH state and the LOW state is 1 to 2 seconds.

[0011] The above mode selection unit may set a 'basic mode' used for a specific purpose in daily life as a higher mode, and may include a tension relaxation mode, a concentration mode, and a sleep induction mode as lower modes of the 'basic mode'.

[0012] The above motion sickness prevention mode has a stimulation pattern that sequentially applies RAMP UP, in which the stimulation intensity sequentially increases in multiple levels, and RAMP DOWN, in which the stimulation intensity sequentially decreases in multiple levels, with stimulation intensity of each level set to 0% for level 0 and 100% for the highest level, such that the difference between each stage is uniform, and the time for performing each level can be 1 to 3 seconds.

[0013] The above mode selection unit further includes a depression response mode, and the depression response mode has a stimulation pattern in which a stimulation pulse of 25 to 40 Hz is sequentially applied in an ON state in which stimulation is applied and an OFF state in which stimulation is not applied, and the length of each of the ON state and the OFF state can be 0.1 to 0.5 seconds.

[0014] The above mode selection unit further includes an ADHD response mode, and the ADHD response mode has a stimulation pattern in which a HIGH state in which a relatively strong stimulus is applied and a LOW state in which a relatively weak stimulus is applied are sequentially applied with a stimulation pulse of 5 to 80 Hz, the stimulation intensity of the LOW state is 30 to 60% of the stimulation intensity of the HIGH state, and the length of each of the HIGH state and the LOW state is configured to be 1 to 10 seconds, but the application time may be determined randomly.

[0015] The above mode selection unit further includes a PTSD response mode, and the PTSD response mode has a stimulation pattern in which a stimulation pulse of 5 to 15 Hz is sequentially applied in an ON state in which stimulation is applied and an OFF state in which stimulation is not applied, and the length of each of the ON state and the OFF state may be 1 to 2 seconds.

[0016] The above mode selection unit may further include a 'symptom response mode' used for the purpose of alleviating symptoms for specific symptoms as a higher mode, and may include a depression response mode, an ADHD response mode, and a PTSD response mode as lower modes of the 'symptom response mode'.

[0017] The present invention, configured as described above, has multiple operation modes specialized for specific purposes, thereby improving the effect of electrical stimulation through a mode according to the user's purpose of use.

[0018] Figure 1 is a schematic diagram illustrating the structure of a vagus nerve stimulation device according to an embodiment of the present invention.

[0019] FIG. 2 is a drawing for explaining information about an electrical stimulation signal in a vagus nerve stimulation device according to an embodiment of the present invention.

[0020] FIG. 3 is a drawing for explaining a stimulation pattern of a tension relaxation mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0021] FIG. 4 is a drawing for explaining a stimulation pattern of a focused mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0022] FIG. 5 is a drawing for explaining a stimulation pattern of a sleep induction mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0023] FIG. 6 is a drawing for explaining a stimulation pattern of a motion sickness prevention mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0024] FIG. 7 is a drawing for explaining a stimulation pattern of a depression response mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0025] FIG. 8 is a drawing for explaining a stimulation pattern of an ADHD response mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0026] FIG. 9 is a drawing for explaining a stimulation pattern of a PTSD response mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0027] An embodiment of the present invention will be described in detail with reference to the attached drawings.

[0028] However, the embodiments of the present invention may be modified in various other forms, and the scope of the present invention is not limited to the embodiments described below. The shapes and sizes of elements in the drawings may be exaggerated for clearer explanation, and elements indicated by the same symbols in the drawings are the same elements.

[0029] Throughout the specification, when a part is said to be "connected" to another part, this includes not only the cases where it is "directly connected" but also the cases where it is "electrically connected" with another element in between. Furthermore, when a part is said to "include" or "comprise" a component, this does not mean that it excludes other components, but rather that it can include or comprise other components, unless otherwise specifically stated.

[0030] Additionally, terms such as "first," "second," etc. are intended to distinguish one component from another and should not limit the scope of the rights. For example, the first component may be referred to as the second component, and similarly, the second component may also be referred to as the first component.

[0031] Figure 1 is a schematic diagram illustrating the structure of a vagus nerve stimulation device according to an embodiment of the present invention.

[0032] The vagus nerve stimulation device equipped with a user identification function of the present embodiment includes a stimulation unit (10), a control unit (20), and a mode selection unit (300).

[0033] The stimulation unit (10) includes one or more electrodes that contact a predetermined location to apply electrical stimulation to the vagus nerve located in the user's ear, and may be structured such that the electrodes are formed on a wearable device worn by the user so that the electrodes maintain contact with the user's ear.

[0034] The electrode comprises at least one electrode per ear, and may include, for example, an electrode inserted into the external auditory canal and an electrode contacting the conchae of the auricle. The specific configuration of the electrode is not particularly limited, and any electrode structure for general vagus nerve stimulation may be applied as long as it does not impair the characteristics of the present invention.

[0035] Wearable devices are typically provided in pairs, one for each ear, but may also be configured to be worn on only one ear. When two wearable devices are used, they may be configured to be completely separate, or connected via separate connecting elements.

[0036] The control unit (20) is a component that transmits an electrical stimulation signal for generating electrical stimulation to the electrode of the stimulation unit.

[0037] The present invention provides electrical stimulation to the vagus nerve of the ear through electrodes for the purpose of alleviating specific symptoms or for other purposes, and the control unit (20) stores information on the electrical stimulation signal and transmits it to the stimulation unit (10) so that the electrical stimulation is performed through the electrodes. The information on the electrical stimulation signal can be applied to all contents of a general vagus nerve stimulation device, and the present invention is characterized in that it includes information on a plurality of modes having specific purposes. In order to explain the information on the electrical stimulation signal, the stimulation pulse and the stimulation pattern are explained separately.

[0038] FIG. 2 is a drawing for explaining information about an electrical stimulation signal in a vagus nerve stimulation device according to an embodiment of the present invention.

[0039] Electrical stimulation through electrodes is performed by applying current, and the form of the current application can be expressed as a stimulation pulse since it is applied in the form of a pulse wave. When such a stimulation pulse is repeated to apply an electrical stimulation, the form of the stimulation application can be expressed as a stimulation pattern by controlling the intensity of the stimulation pulse or stopping the stimulation. The electrical stimulation mode specified in the present invention is distinguished by an electrical stimulation signal composed of a stimulation pulse and a stimulation pattern. The stimulation pulse can be treated in the same way as the current applied to the electrode, and the intensity of the stimulation pulse and the intensity of the stimulation pattern can be treated in the same way as the intensity of the current. Meanwhile, for the convenience of expression when indicating the stimulation pattern, only the plus region is indicated, but this does not mean that the electrical stimulation in the minus region is excluded.

[0040] The mode selection unit (300) is a component that allows the user to select the type of electrical stimulation, and the specific configuration for selecting and inputting the type of electrical stimulation is not particularly limited.

[0041] The vagus nerve stimulation device of this embodiment has multiple modes that can be selected from the mode selection unit (300), and specifically includes a tension relaxation mode, a concentration mode, a sleep induction mode, a motion sickness prevention mode, a depression response mode, an ADHD response mode, a PTSD response mode, etc.

[0042] Each mode selectable from the mode selection unit (300) has an electric stimulation signal having preset stimulation pulse and stimulation pattern characteristics, which are pre-stored in the control unit (20). When the user selects a specific mode from the mode selection unit (300), the control unit (20) transmits an electric stimulation signal reflecting the characteristics of the stored mode to the electrodes, thereby performing electric stimulation on the user. The electric stimulation signal set for each mode is set based on whether a stable or excited state is required from the user in each situation and the frequency of brain waves required in each situation.

[0043] Below, each mode is described. In the present invention, the application time of each mode can be adjusted according to the individual's condition based on a predetermined basic time, and in this embodiment, 15 minutes is set as the basic time.

[0044] FIG. 3 is a drawing for explaining a stimulation pattern of a tension relaxation mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0045] Tension-relieving Middle Frequency (TRMF) mode is a mode that relieves tension by activating the parasympathetic nervous system in a state of tension and sympathetic activation, thereby balancing the autonomic nervous system and achieving a stress-reducing effect. To activate the parasympathetic nervous system, stimulation pulses of 10–30 Hz are continuously applied. The resulting stimulation pattern in tension-relieving mode is shown in the diagram. The stimulation intensity can be adjusted based on the user's current condition and individual characteristics, such as sensitivity, and this is consistent across all modes. Furthermore, the overall intensity scale may change over time depending on the user's sensitivity, but the basic structure of the stimulation pattern remains intact.

[0046] FIG. 4 is a drawing for explaining a stimulation pattern of a focused mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0047] Concentration enhancement frequency (CEF) activates the alpha wave band (8-13 Hz) of brain waves to improve study and work efficiency, enable mental concentration, and achieve the effect of maximizing memory and concentration. A stimulation pulse of 25-40 Hz is applied, and the electrical stimulation is applied in a stimulation pattern in which the ON state (where stimulation is applied) and the OFF state (where stimulation is not applied) are sequentially applied, as shown in the figure. The ON state and OFF state each last 1-2 seconds.

[0048] FIG. 5 is a drawing for explaining a stimulation pattern of a sleep induction mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0049] Sleep-Inducing Low Frequency (SILF) mode activates the delta and theta wave bands, which are low-frequency bands of brain waves below 8 Hz, to induce sleep as well as to relax and feel comfortable. A stimulation pulse of 1 to 10 Hz is applied, and the electrical stimulation is applied in a stimulation pattern in which a relatively strong HIGH state and a relatively weak LOW state are sequentially applied, as shown in the figure. The stimulation intensity of the HIGH and LOW states is 30 to 60% of the HIGH state stimulation intensity, and the length of each HIGH and LOW state is configured to be the same in the range of 1 to 2 seconds.

[0050] FIG. 6 is a drawing for explaining a stimulation pattern of a motion sickness prevention mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0051] Motion sickness prevention high frequency (MHF) mode activates the high-frequency beta and gamma wave bands of brain waves to induce a state of wakefulness, thereby reducing the occurrence of motion sickness. A stimulation pulse of 30 to 60 Hz is applied, and the electrical stimulation is applied in a stimulation pattern that sequentially applies RAMP UP, in which the intensity of the stimulation increases sequentially in multiple levels, and RAMP DOWN, in which the intensity of the stimulation decreases sequentially in multiple levels, as shown in the figure. RAMP UP and RAMP DOWN levels can be configured to have three or more levels, and the time for each level to be performed is 1 to 3 seconds. The stimulation intensity of each level is configured so that the difference between each step is uniform, with level 0 set to 0% and the highest level set to 100%. For example, it can be configured as 0 level:1 level:2 level:3 level:4 level=0:25:50:75:100 or 0 level:1 level:2 level:3 level:4 level:5 level=0:20:40:60:80:100, and the maximum level of stimulation intensity can be adjusted according to the user's current condition and personal characteristics such as sensitivity, as previously discussed.

[0052] FIG. 7 is a drawing for explaining a stimulation pattern of a depression response mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0053] Depression Prevention High Frequency (DHF) mode is designed to lift the mood of depressed users and induce a lively and excited state. A stimulation pulse of 25 to 40 Hz is applied, and the electrical stimulation is applied in a stimulation pattern in which the ON state, in which the stimulation is applied, and the OFF state, in which the stimulation is not applied, are sequentially applied, as shown in the figure. The length of each ON state and OFF state is 0.1 to 0.5 seconds. Compared to the focused mode, the quicker transition between the ON state and OFF state can be achieved, thereby inducing an energetic state.

[0054] FIG. 8 is a drawing for explaining a stimulation pattern of an ADHD response mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0055] ADHD-relieving variable frequency (ARVF) mode is a mode for alleviating the symptoms of ADHD, such as decreased concentration and distraction. It applies a stimulation pulse of 5 to 80 Hz, and applies electrical stimulation in a stimulation pattern in which a relatively strong HIGH state and a relatively weak LOW state are sequentially applied, as shown in the figure. The stimulation intensity of the HIGH and LOW states is 30 to 60% of the HIGH state stimulation intensity, and the length of each HIGH and LOW state is configured to be 1 to 10 seconds, but the application time is randomly determined. Compared to the sleep-inducing mode, there are differences in the cycle of the stimulation pulse and the length of the HIGH and LOW states. In particular, by randomly applying the length of the HIGH and LOW states, the effect of alleviating ADHD symptoms can be obtained.

[0056] FIG. 9 is a drawing for explaining a stimulation pattern of a PTSD response mode applied to a vagus nerve stimulation device according to an embodiment of the present invention.

[0057] PTSD-relieving middle frequency (PRMF) mode is a mode that helps users suffering from PTSD overcome the effects of past memories and fear through a calming effect. It applies a stimulation pulse of 5 to 15 Hz, and as shown in the diagram, the electrical stimulation is applied in a stimulation pattern in which the ON state, in which the stimulation is applied, and the OFF state, in which the stimulation is not applied, are applied sequentially. The ON and OFF states each last 1 to 2 seconds. By configuring the frequency of the stimulation pulse to be lower than in the focused mode, it can be effective in alleviating PTSD symptoms.

[0058] At this time, the tension relaxation mode, concentration mode, sleep induction mode, motion sickness prevention mode, depression response mode, ADHD response mode, and PTSD response mode applied in this embodiment may be simply arranged at the same level in the mode selection unit (300), but may also be presented grouped into separate upper categories. For example, a 'basic mode' used for a specific purpose in daily life and a 'symptom response mode' used for the purpose of symptom relief for a specific symptom may be set as upper categories of individual modes, and a tension relaxation mode, concentration mode, sleep induction mode, and motion sickness prevention mode may be arranged as sub-modes of the basic mode, and a depression response mode, ADHD response mode, and PTSD response mode may be arranged as sub-modes of the symptom response mode.

[0059] Meanwhile, the mode of the electric stimulation signal presented in the mode selection unit (300) and stored in the control unit (20) can be additionally downloaded through wired or wireless communication, or can be added using a separate storage device.

[0060] The present invention has been described above through preferred embodiments. However, the above-described embodiments are merely illustrative of the technical idea of ​​the present invention. Those skilled in the art will understand that various changes may be made without departing from 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 a scope equivalent thereto should be interpreted as being included within the scope of the rights of the present invention.

Claims

1. A stimulating unit including an electrode that is worn on at least one of the left and right ears and applies electrical stimulation to the vagus nerve of the external ear; A control unit that transmits an electric stimulation signal for generating an electric stimulation to the above-mentioned stimulation unit; and Includes a mode selection section for the user to select a stimulation mode, The above mode selection unit includes a plurality of modes in which electric stimulation signals including a stimulation pattern constituting the frequency of the stimulation pulse and the form of application of the stimulation are preset, and the control unit stores information on the electric stimulation signal corresponding to each mode and transmits the electric stimulation signal corresponding to the mode selected by the user to the stimulation unit. A vagus nerve stimulator, characterized in that the above mode selection unit includes a tension relaxation mode, a concentration mode, and a sleep induction mode.

2. In claim 1, A vagus nerve stimulation device characterized in that the above-mentioned tension relaxation mode has a stimulation pattern that continuously applies a stimulation pulse of 10 to 30 Hz for a predetermined period of time.

3. In claim 1, The above-mentioned focused mode is a vagus nerve stimulation device characterized in that it has a stimulation pattern in which a stimulation pulse of 25 to 40 Hz is sequentially applied in an ON state in which stimulation is applied and an OFF state in which stimulation is not applied, and the length of each of the ON state and the OFF state is 1 to 2 seconds.

4. In claim 1, The above sleep induction mode is a vagus nerve stimulation device characterized in that it has a stimulation pattern in which a HIGH state in which a relatively strong stimulus and a LOW state in which a relatively weak stimulus are applied are sequentially applied with a stimulation pulse of 1 to 10 Hz, the stimulation intensity of the LOW state is 30 to 60% of the stimulation intensity of the HIGH state, and the length of each of the HIGH state and the LOW state is 1 to 2 seconds.

5. In claim 1, A vagus nerve stimulator characterized in that the above mode selection unit is set as a 'basic mode' used for a specific purpose in daily life as a higher mode, and includes a tension relaxation mode, a concentration mode, and a sleep induction mode as lower modes of the 'basic mode'.

6. In claim 1, The above mode selection section further includes an anti-motion sickness mode, The above motion sickness prevention mode has a stimulation pattern that sequentially applies a RAMP UP stimulation pulse of 30 to 60 Hz in which the intensity of the stimulation is sequentially increased in multiple levels and a RAMP DOWN stimulation pulse in which the intensity of the stimulation is sequentially decreased in multiple levels, and the stimulation intensity of each level is configured such that the difference between each stage is uniform with level 0 set to 0% and the highest level set to 100%, and the time for performing each level is 1 to 3 seconds.

7. In claim 1, The above mode selection section further includes a depression response mode, The above depression response mode is a vagus nerve stimulation device characterized in that it has a stimulation pattern in which a stimulation pulse of 25 to 40 Hz is sequentially applied in an ON state in which stimulation is applied and an OFF state in which stimulation is not applied, and the length of each of the ON state and the OFF state is 0.1 to 0.5 seconds.

8. In claim 1, The above mode selection section further includes an ADHD response mode, The above ADHD response mode is a vagus nerve stimulation device characterized in that it has a stimulation pattern in which a HIGH state in which a relatively strong stimulus and a LOW state in which a relatively weak stimulus are applied are sequentially applied with a stimulation pulse of 5 to 80 Hz, the stimulation intensity of the LOW state is 30 to 60% of the stimulation intensity of the HIGH state, and the length of each of the HIGH state and the LOW state is configured to be 1 to 10 seconds, but the application time is randomly determined.

9. In claim 1, The above mode selection section further includes a PTSD response mode, The above PTSD response mode is a vagus nerve stimulation device characterized in that it has a stimulation pattern in which a stimulation pulse of 5 to 15 Hz is sequentially applied in an ON state in which stimulation is applied and an OFF state in which stimulation is not applied, and the length of each of the ON state and the OFF state is 1 to 2 seconds.

10. In claim 5, A vagus nerve stimulator characterized in that the above mode selection unit further includes a 'symptom response mode' used for the purpose of alleviating symptoms for specific symptoms as an upper mode, and includes a depression response mode, an ADHD response mode, and a PTSD response mode as lower modes of the 'symptom response mode'.

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