WO2023163547A1

WO2023163547A1 - Noninvasive stimulation device

Info

Publication number: WO2023163547A1
Application number: PCT/KR2023/002668
Authority: WO
Inventors: 김민수; 양경태; 오석환; 오도연
Original assignee: 뉴로엔(주)
Priority date: 2022-02-28
Filing date: 2023-02-24
Publication date: 2023-08-31
Also published as: KR20230128637A

Abstract

The present invention relates to a noninvasive stimulation device comprising: a helmet body; a seesaw support member which is coupled to one side of the helmet body through a hinge, and which has one or more upper branch parts extending over the hinge and a lower branch part connected below the hinge; one or more electrode modules coupled to the upper branch parts of the seesaw support member; and one or more electrode modules coupled to the lower branch part of the seesaw support member.

Description

non-invasive stimulation device

The present invention relates to a non-invasive stimulation device suitable for a brain stimulation health care system.

Mild cognitive impairment refers to a state in which memory or other cognitive functions are markedly reduced to the extent that it can be confirmed in an objective test, but the ability to perform daily life is preserved, so it is not yet dementia. However, mild cognitive impairment corresponds to a high-risk group for dementia. In the case of normal elderly, the rate of progressing to dementia is about 1 to 2% each year, but it is known that about 10 to 15% of people with mild cognitive impairment progress to dementia every year. In the case of mild cognitive impairment, about 80% of patients with mild cognitive impairment belong to the high-risk group for dementia after 6 years.

Treatment methods for mild cognitive impairment include drug therapy, cognitive therapy, and brain stimulation therapy.

Medications for Alzheimer's disease, ginkgo biloba extract preparations, choline precursor preparations, vitamin B group supplements, etc. can be used, and antidepressants may be used if depression is the cause. However, drug treatment has not yet been proven to have a therapeutic effect on mild cognitive impairment, and above all, the risk of misuse and abuse of the drug is very high.

Cognitive therapy is cognitive rehabilitation for the brain function of a degraded area, and corresponds to a treatment method for improving cognitive deficits and improving social function by using scientific learning principles. However, cognitive therapy has a problem in that it takes a long time to improve and the effect is weak.

Brain stimulation treatment includes invasive treatment such as deep brain stimulation and non-invasive treatment that stimulates the brain from the outside with magnetism, electricity, or ultrasound. However, since invasive treatment always has a risk of side effects or complications after surgery, research on non-invasive treatment is being actively conducted.

Non-invasive treatment of mild cognitive impairment does not show an immediate effect compared to invasive treatment, but has fewer side effects and has a significant effect compared to cognitive treatment.

A typical example of non-invasive treatment is a method using transcranial current stimulation (tCS), and specifically, a method of activating a specific part of the brain of a subject or causing relaxation with tDCS (transcranial direct current stimulation) this is widely used.

Treatment using tDCS is less effective when the patient's tension or stress is high. Conventionally, in order to increase the effect of tDCS, an attempt was made to lower the tension or stress of the subject by playing music or the like, but there is a problem that the effect varies greatly from person to person.

In addition, tDCS causes discomfort such as tingling pain in the skin at the beginning of the procedure, and due to this discomfort, the periodic and long-term availability of non-invasive stimulation devices is lowered, and even if used, there is a problem of increasing tension or stress of the subject.

In addition, periodic and continuous procedures are required to increase the effectiveness of non-invasive treatment. However, it is realistically impossible for the subject to undergo more than one or two treatments at the hospital every day. In addition, a method using electrical stimulation, which is a representative example of non-invasive treatment of mild cognitive impairment, is to attach electrodes to the scalp and apply electrical stimulation, but the conventional electrical stimulation device available for mild cognitive impairment is too difficult for ordinary people to wear. there is For example, there are problems in that it is difficult to position a plurality of electrodes of the electric stimulation device in appropriate positions, and hair prevents adhesion of the electrodes.

As related prior art, Korean Patent Publication No. 10-2014-0080299 (2014.06.30) has been published.

The present invention has been made to solve the above-mentioned needs and / or problems, and provides a non-invasive stimulation device that can easily attach electrodes to the head of a subject.

The present invention provides a stimulator that can prevent a burning phenomenon due to a current flowing through an electrode and is easy to attach and detach and replace a pad.

The present invention provides a device in which a mechanism in which a plurality of electrodes can be closely attached according to various head sizes and head shapes of a person to be treated so that a non-invasive stimulation device can be used universally is operated.

Meanwhile, other unspecified objects of the present invention will be additionally considered within the scope that can be easily inferred from the following detailed description and effects thereof.

A non-invasive stimulation device according to an embodiment of the present invention includes a helmet body; a seesaw support member including at least one upper branch portion coupled to one side of the helmet body through a hinge and extending above the hinge, and a lower branch portion connected below the hinge; one or more electrode modules coupled to an upper branch of the seesaw support member; and one or more electrode modules coupled to the lower branch portion of the seesaw support member.

In a state in which the upper branch of the seesaw support member is advanced, the lower branch is retracted toward the helmet body, and when the upper branch is retracted, the seesaw support member is rotated around the hinge so that the lower branch is advanced. The rotation angle of the seesaw support hinge is automatically appropriately adjusted according to the head shape of the user so that the plurality of electrodes contact the human body with uniform pressure.

The non-invasive stimulation device according to another embodiment of the present invention may further include a torsion spring connected between the hinge of the seesaw support member and the helmet body.

When an external force is not applied to the seesaw support member, the upper branch portion of the seesaw support member may advance and the lower branch portion may maintain a retracted state.

A non-invasive stimulation device according to another embodiment of the present invention includes a close-fitting band wound on an inner surface of the helmet body; a dial coupled to the close-fitting band; And one or more electrode modules coupled to the close contact band may be further provided.

When the dial is rotated in the tightening direction, the electrode modules coupled to the contact band and the seesaw support member may be in close contact with the head of the person to be treated at the same time.

Each of the electrode modules includes a non-conductive silicon holder in the form of a container including an inner space defined by a side wall; a conductive silicon pad disposed in an inner space of the non-conductive silicon holder; an adhesion pad disposed on the conductive silicon pad and exposed to the outside; and a metal pin inserted into the hollow of the non-conductive silicon holder and the hollow of the conductive silicon pad 13; and a non-conductive silicon pillar that covers the hollow portion of the conductive silicon pad into which the metal pin is inserted and protrudes from the surface of the contact pad through the hollow of the contact pad.

The non-conductive silicon filler includes a flat plate part; And it may include a protruding portion protruding from the lower surface of the flat plate portion. An upper surface of the flat plate part may include one or more protrusions protruding toward an inner surface of the non-conductive silicon holder. A portion of the conductive silicon pad may be filled between the non-conductive silicon pillar and the metal pin.

The seesaw support member may further include a sensor module disposed on the lower branch portion.

A non-invasive stimulation device according to another embodiment of the present invention includes a helmet body and a seesaw support member coupled to one side of the helmet body through a hinge and seesaw movement in conjunction with the head of a person to be treated. One or more electrode modules may be coupled to upper branches of the seesaw support member. At least one of an electrode module and a sensor module may be coupled to a lower branch of the seesaw support member.

A non-invasive stimulation device according to another embodiment of the present invention includes a helmet body having an open bottom; a close-fitting band wound around the inner surface of the helmet body; a dial that is coupled to the close-fitting band and adjusts the diameter of the close-up fan along the rotational direction; first and second electrode modules coupled to the contact band; third and fourth electrode modules on an upper inner surface of the helmet body; a seesaw support member coupled to one side of the helmet body through a hinge, seesaw movement in conjunction with the head of the person to be treated, and having an upper support portion above the hinge and a lower support portion below the hinge; one or more electrode modules coupled to an upper branch of the seesaw support member; and at least one of an electrode module and a sensor module coupled to the lower branch portion of the seesaw support member.

According to the present invention, since mild cognitive impairment can be prevented by being installed on equipment such as a helmet, the subject can safely stimulate the brain.

The present invention can be manipulated to operate according to a predetermined program, so there is an effect that the subject can perform brain stimulation safely and conveniently.

The present invention is in the form of a helmet worn on the head of the pisisulja, and can be easily worn by the pisisulja alone.

The electrode device of the present invention changes the electrode structure of the electrode module by adding a non-conductive silicon pillar protruding higher than the contact pad in the center of the contact pad in the triple structure of a non-conductive silicon holder, a conductive silicon pad, and an contact pad, thereby generating current It is possible to secure a path and a moisture permeation path, facilitate attachment and detachment of the contact pad, and prevent a burning phenomenon that may occur in the center of the contact pad.

In the present invention, when the subject wears a non-invasive stimulator in the form of a helmet, the electrode modules coupled to the seesaw support member are in contact with the subject's head in conjunction with the subject's head, and when one dial is rotated in the tightening direction, all electrodes The modules may be simultaneously adhered to the head of the person being treated at each of the electrical stimulation sites. Therefore, the present invention can improve the convenience when putting on and taking off the non-invasive stimulator, and can simplify the structure of the tight band and the dial coupled to the non-invasive stimulator.

The effects of the present invention are not limited to the effects mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the description of the claims.

1 is a schematic structural diagram of a non-invasive stimulation device according to an embodiment of the present invention.

2a is a diagram showing a brain stimulation area when five electrode modules are applied to a non-invasive stimulation device.

Figure 2b is a diagram showing a brain stimulation area when seven electrode modules are applied to a non-invasive stimulation device.

3 to 5 are schematic reference views for explaining various electrical stimulation of the non-invasive stimulation device according to an embodiment of the present invention.

Figure 6 schematically shows the form of electrical stimulation of tDCS and tACS.

7 is a reference diagram for explaining a check mode, a buffer mode, and a main mode of a non-invasive stimulator according to an embodiment of the present invention.

8 is a schematic reference diagram showing an example of a program of a non-invasive stimulation device according to an embodiment of the present invention.

9a and 9b are views showing a helmet with a built-in non-invasive stimulator according to an embodiment of the present invention from various angles.

10 is an exploded perspective view of the electrode module excluding the contact pad.

FIG. 11 is a view showing an electrode module in which components shown in FIG. 10 are assembled.

12 is a partially cut-away perspective view showing an electrode module in which an adhesion pad is mounted in a non-conductive silicon holder.

13 is a partially cut-away perspective view showing a metal cap disposed on a rear surface of a non-conductive silicon holder.

14 is a cross-sectional view showing a combination of a metal cap and a magnet of an electrode module.

15 and 16 are perspective views showing a coupling relationship between a dial, an adhesive band, a seesaw connecting portion, and electrode modules.

17 is a view showing the rotation of the seesaw connection.

18 is a partially cut-away perspective view showing a structure in which the seesaw connection part is connected to the helmet body.

19A to 19C are diagrams showing the state of the seesaw support member before the operator wears the helmet in which the non-invasive stimulator is embedded.

20A to 20C are diagrams showing a state of a seesaw support member before a person to be operated on wears a helmet in which a non-invasive stimulator is embedded.

It is revealed that the accompanying drawings are illustrated as references for understanding the technical idea of the present invention, and thereby the scope of the present invention is not limited thereto.

Hereinafter, with reference to the drawings, look at the configuration of the present invention guided by various embodiments of the present invention and the effects resulting from the configuration. In the description of the present invention, if it is determined that a related known function may unnecessarily obscure the subject matter of the present invention as an obvious matter to those skilled in the art, the detailed description thereof will be omitted.

The term "module" used in this document may include a unit implemented by hardware, software, or firmware, and may be used interchangeably with terms such as logic, logic block, component, or circuit, for example. A module may be an integrally constructed component or a minimal unit of components or a portion thereof that performs one or more functions.

In this document, a "module" or "node" performs tasks such as moving, storing, and converting data using a computing device such as a CPU or AP. For example, a “module” or “node” may be implemented as a device such as a server, PC, tablet PC, or smart phone.

Hereinafter, a non-invasive stimulation device according to an embodiment of the present invention will be described with reference to the drawings.

The non-invasive stimulation device 100 according to an embodiment of the present invention is configured to non-invasively apply electrical stimulation through electrodes in close contact with the scalp of a subject. Through such electrical stimulation, various diseases caused by the brain can be prevented, treated, and managed. For example, by using the non-invasive stimulation device 100 according to an embodiment of the present invention, mild cognitive impairment as well as insomnia, depression, convulsive diseases, pain, memory improvement, motor learning ability improvement, intellectual disability, addiction diseases, and Schizophrenia can be prevented, treated and managed.

The non-invasive stimulation device 100 according to an embodiment of the present invention includes a stimulation device 110, a power supply unit 120, and a control unit 140.

The stimulation device 110 includes a plurality of electrode modules 111 to 117 that apply current to pads (or patches) that are in close contact with various positions on the head of the person to be treated. In the example of FIG. 1 , the stimulation device 110 is an example including the first to seventh electrode modules 111 to 117, but the present invention is not limited thereto. For example, stimulation device 110 may include three or more electrode modules.

The control unit 140 receives power from the power supply unit 120 and causes current to flow through the electrode modules 111 to 117 . Some of the plurality of electrode modules 111 to 117 may serve as positive electrodes, and others may serve as negative electrodes. In addition, it is also possible that current flows only in some of the plurality of electrode modules 111 to 117 and current does not flow in other portions. That is, the polarity or operation of each electrode unit may be changed according to a program set in the control unit 120 .

When five electrode modules are disposed in the non-invasive stimulation device 100 without the third and fourth electrode modules, as shown in FIG. 2A, the first electrode module 111 is located at a position corresponding to the left frontal lobe of the subject. In close contact, the second electrode module 112 is closely adhered to a position corresponding to the right frontal lobe of the person to be treated, and the fifth electrode module 115 includes at least a part of the left parietal lobe, left occipital lobe, and left temporal lobe of the person to be treated. The sixth electrode module 116 may adhere to a position corresponding to an area including at least a portion of the right parietal lobe, right occipital lobe, and right temporal lobe of the subject. In addition, the seventh electrode module 117 may be in close contact with the head of the person to be treated at a different position from the

electrode modules

111, 112, 115, and 116, and for example, at least part of the back of the person's ears, back of the head, and back of the neck of the person to be treated. It can be in close contact with the area containing it. The seventh electrode module 117 may be a positive electrode from which current is emitted or a negative electrode from which current is received.

When seven electrode modules are disposed in the non-invasive stimulation device 100, as shown in FIG. 2B, the first electrode module 111 adheres to a position corresponding to the left frontal lobe of the subject, and the second electrode module 112 ) adheres to the position corresponding to the right frontal lobe of the subject, the third electrode module 113 adheres to the left kinesthetic area between the left frontal lobe and the left parietal lobe of the subject, and the fourth electrode module 114 adheres to the right side of the subject It may adhere to a position corresponding to the right kinesthetic region between the frontal lobe and the right parietal lobe. The fifth electrode module 115 may adhere to the left temporal parietal region of the person to be treated, and the sixth electrode module 116 may closely adhere to the right temporal parietal region of the person to be treated. Further, the seventh electrode module 117 may adhere to an area including at least a part of the back of the ear, the back of the head, and the back of the neck of the person to be treated. The seventh electrode module 117 may be a positive electrode from which current is emitted or a negative electrode from which current is received.

Each of the electrode modules 111 to 117 may apply electrical stimulation to the head of the person to be treated through a pad containing water. However, it is not limited thereto, and the electrode modules 111 to 117 may include a material through which current can be constantly transmitted without moisture as needed.

In this embodiment, it has been described that electrical stimulation is applied to the head of the person being treated using the electrode modules 111 to 117, but is not limited thereto. For example, by using one or more of the electrode modules 111 to 117, electrical stimulation may be applied to a region other than the head of the person to be treated.

Electrical stimulation signals applied to the electrode modules 111 to 117 may be controlled by the controller 140 .

The control unit 140 may control the electrode modules 111 to 117 so that transcranial current stimulation (tCS) is applied to a desired region on the head of the person to be treated. The type of transcranial current stimulation used in the present invention may be at least one of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and transcranial random-noise stimulation (tRNS), or a combination thereof. In particular, when the subject wears a helmet with a built-in non-invasive stimulator on his or her head and starts brain electrical stimulation, the control unit 140 first performs tACS, and then tDCS can be performed after the subject's condition returns to a normal state. there is. With such a configuration, it is possible to further improve the treatment effect on the person to be treated. This will be described later.

The power supply unit 120 may supply power necessary for the operation of the non-invasive stimulation device 100 according to an embodiment of the present invention through the power source used.

A plurality of stimulation signal patterns are stored in the memory of the controller 140 to provide various types of electrical stimulation according to the symptoms of the person to be treated.

The controller 140 supplies electrical stimulation signals to the electrode modules 111 to 116 to control the first to sixth electrode modules 111 to 116 as positive electrodes and the fifth electrode module 115 as negative electrodes. can do. Alternatively, the electrical stimulation signal may be provided to each of the electrode modules 111 to 117 so that the first to sixth electrode modules 111 to 116 become negative electrodes and the seventh electrode module 117 becomes a positive electrode. Alternatively, in a state in which power is not supplied to the third to sixth electrode modules 113 to 116, the first and

second electrode modules

111 and 112 become positive electrodes, and the seventh electrode module 117 An electrical stimulation signal may be provided to some electrode modules to become negative electrodes. An electrical stimulation location and an electrical stimulation signal pattern may be selected according to a program set according to a patient's symptom or diagnosis result.

The control unit 140 may adjust the amount of current supplied to each of the electrode modules 111 to 117 by adjusting the power supplied from the power supply unit 120 . For example, the current flowing through the electrode modules 111 to 117 may be about 0.5 mA to each electrode, but is not limited thereto.

The power supply unit 120 may supply power necessary for driving the electrode modules 111 to 117, and may be a battery if necessary. When the power source 120 is a battery, a rechargeable secondary battery may be used.

The non-invasive stimulation device 100 of the present invention may further include a sensor module 130 for measuring various conditions of the user. The sensor module 130 may adhere to at least one area of the subject's head, for example, the back of the ear, the back of the head, and the back of the neck of the subject. When the sensor module 130 is closely attached to the back of the ear, the seventh electrode module 117 may be placed on the right side and the sensor module 130 on the left side for more effective biometric information (e.g., electrocardiogram, heart rate, etc.) measurement. .

The sensor module 130 may include an electrocardiogram sensor module for measuring the electrocardiogram of the person being treated. The electrocardiogram sensor module collects biometric information of the subject and checks whether the current applied to the subject's head through the electrode modules 111 to 117 causes problems to the human body. For example, when a subject wears a helmet with a built-in non-invasive stimulator and starts a brain electrical stimulation procedure, the control unit 140 first performs tACS, and then tDCS can be performed after the subject's condition returns to a normal state. However, the electrocardiogram sensor module may play a role in determining whether or not the condition of the subject is in a normal state. Whether or not the recipient's condition is in a normal state can be determined using information collected on the electrocardiogram in the comfortable state of the recipient, or information on the electrocardiogram in a normally known normal state (for example, heart rate at rest by age). can be used to judge.

When the sensor module is omitted in the non-invasive stimulator, an electrode module omitted from the drawing may be added to the sensor module position instead of the sensor module.

The control unit 140 may adjust the intensity of the current flowing through each of the electrode modules 111 to 117 according to the user's selection, for example, the medical staff or the person receiving treatment in response to the input signal received through the user interface input in the drawing. there is. For example, the controller 140 may adjust the current flowing through each of the electrode modules 111 to 117 in the range of 0.1 mA to 5 mA in response to a user input. Illustratively, the control unit 140 may adjust the current in units of 0.5 mA. In addition, the control unit 140 can automatically adjust the intensity of the current according to the mode as needed.

The control unit 140 receives the body information of the person to be treated transmitted from the sensor module 130 . The controller 140 may store the received body information of the person to be treated. Meanwhile, the control unit 140 may analyze the received human body information of the person to be treated and change the electrical stimulation signal pattern or signal strength transmitted to the electrode unit.

The non-invasive stimulation device 100 of the present invention may further include a communication module 150. The communication module 150 may perform standard short-range communication such as WiFi and Bluetooth. The controller 140 may transmit information about the operation of the non-invasive stimulation device 100, including body information of the person to be treated, to a terminal (eg, a smartphone, a computer, etc.) of the person to be treated through the communication module 150. In addition, the control unit 140 may transmit information about a driving mode using the non-invasive stimulator 100 or the number of times of use to a terminal of a person receiving treatment. In this case, the person to be treated may receive guidance on the use of the non-invasive stimulation device 100 and may receive product management.

2a to 5 are schematic reference diagrams for explaining various electrical stimulation of a non-invasive stimulation device according to an embodiment of the present invention.

2A and 2B are reference diagrams illustrating electrical stimulation in a mode for simultaneously improving memory and concentration.

When trying to improve memory and concentration at the same time, it is necessary to stimulate the frontal lobe in charge of memory and the parietal lobe in charge of concentration in a direction that is activated at the same time. Therefore, in the memory and concentration improvement mode, the first electrode module 111, the second electrode module 112, the fifth electrode module 115, and the sixth electrode module 116 operate as positive electrodes under the control of the controller 140. and the seventh electrode module 117 is driven as a negative electrode.

3 is a reference diagram illustrating electrical stimulation in a memory improvement mode.

If you want to improve your memory, you need to stimulate the frontal lobe in charge of memory in a direction that activates it. Therefore, in the memory improvement mode, under the control of the controller 140, the first electrode module 111 and the second electrode module 112 are driven with positive electrodes, and the seventh electrode module 117 is driven with negative electrodes. At this time, the third to sixth electrode modules 113 to 116 may not be driven.

4 is a reference diagram illustrating electrical stimulation in a concentration improvement mode.

If you want to improve your concentration, you need to stimulate the parietal lobe in charge of concentration in a direction that activates it. Therefore, in the concentration improvement mode, under the control of the controller 140, the fifth and

sixth electrode modules

115 and 116 are driven with positive electrodes, and the seventh electrode module 117 is driven with negative electrodes. At this time, the first to fourth electrode modules 111 to 114 may not be driven.

5 is a reference diagram explaining electrical stimulation in sleep mode (insomnia improvement mode).

In order to induce sleep, it is necessary to stimulate the brain in an overall resting direction. In the sleep mode, under the control of the controller 140, four or more of the first to sixth electrode modules 111 to 116 may be driven with negative electrodes, and the seventh electrode module 117 may be driven with positive electrodes.

In addition to the above modes, one or more of the electrode modules 111 to 117 may be driven to stimulate one or more of the frontal lobe and parietal lobe in the case of improving language ability, visuospatial ability, emotion regulation, and auditory ability.

The controller 140 may block current applied to the electrode modules 111 to 117 according to the user's electrocardiogram measured by the sensor module 130 or in response to a user input. For example, when the user's electrocardiogram measured by the sensor module 130 is out of the normal range or an interrupt is generated according to a user input, current is cut off in the electrode modules 111 to 117 to stop the electrical stimulation applied to the subject. can

Electrical stimulation generated in each mode of FIGS. 2A to 5 may be applied as tDCS. The modes shown in FIGS. 2A to 5 may be combined to form a program.

Figure 6 schematically shows the electrical stimulation signal form of tDCS and tACS.

In the case of tDCS, direct current is used, and electrical stimulation signals of the same polarity are generally applied to the electrode modules 111 to 117 for several minutes. In contrast, tACS uses alternating current and applies electrical stimulation signals in the form of square waves (dotted lines) or sinusoidal waves (solid lines) to the electrode modules 111 to 117.

tDCS regulates spontaneous neural activity in the brain through electrical stimulation with the same polarity. For example, tDCS is effective in regulating decision-making, memory, language, and sensory perception by brain region. In comparison, since tACS uses an alternating current whose polarity is periodically reversed, it is practically impossible to control the directionality (eg, upward or downward) of current in the brain region. Therefore, tDCS is widely used rather than tACS to prevent, treat, and manage depression, convulsive disease, pain, intellectual disability, addiction disease, and mild cognitive impairment, or to improve memory and motor learning ability. However, the effectiveness of tDCS may be reduced due to fatigue or stress of the recipient. In addition, tDCS causes discomfort such as tingling pain in the skin at the beginning of the procedure, and due to this discomfort, the possibility of periodic and long-term use of the non-invasive stimulation device by the person to be treated is lowered, and even if used, the stress of the person to be treated can be increased. In particular, when cognitive decline occurs, the anxiety and tension of the subject increase, and the discomfort of tDCS can further increase the anxiety and tension of the subject.

The non-invasive stimulation device 100 according to an embodiment of the present invention proposes a program configured to solve the above problems of tDCS.

7 is a reference diagram for explaining a check mode, a buffer mode, and a main mode of the non-invasive stimulation device 100 according to an embodiment of the present invention. Electrical stimulation signal patterns according to each mode may be stored in the memory of the controller 140 .

When a person to be treated selects one of the programs provided by the non-invasive stimulator, the controller 140 first performs a check mode. In the check mode, it is checked whether the person to be treated properly wears the helmet in which the non-invasive stimulator is embedded. In the check mode, the resistance of the electrode modules 111 to 117 is measured, and an appropriate action is guided to the person to be treated according to the range of the resistance value. For example, the control unit 140 is normal when the impedance of the electrode modules 111 to 117 is lower than a preset reference value, and wet when the impedance of the electrode modules 111 to 117 is about 1 to 2 times higher than the reference value. When the impedance of the electrode modules 111 to 117 exceeds twice the reference value due to lack of moisture in the pad, it may be determined that the pad adhesion of the electrode modules 111 to 117 is poor.

When all of the electrode modules 111 to 117 are determined to be normal, a buffer mode is performed. The buffer mode serves to reduce skin irritation caused by the tDCS in the main mode by adapting the skin of the subject in contact with the subject's head to electrical stimulation using tACS. Electrical stimulation signals of 4 to 40 Hz can be used for tACS. Preferably, the buffer mode (mode 0) may use tACS (alpha). tACS (alpha) is between 8 and 12 Hz. As meaning electrical stimulation, it has the effect of relieving the tension of the pisisulja. Therefore, if the buffer mode is performed first and then the main mode is performed, the treatment effect of the main mode is further increased.

The main mode may be divided into at least one of a memory improvement mode, a concentration improvement mode, a memory improvement and concentration improvement mode at the same time, and a sleep mode. The main mode consists of ramp up-stimulation-ramp down. By setting the ramp-up step at the beginning of stimulation in the main mode, sufficient time to adapt to the skin stimulation of the person to be treated can be given, and discomfort of the person to be treated can be reduced.

8 is a schematic reference diagram showing various examples of programs of the non-invasive stimulation device 100 according to an embodiment of the present invention.

8 (a) is a program in which memory improvement mode (mode I), concentration improvement mode (mode II), memory and concentration improvement mode (mode III) are sequentially progressed, and finally, sleep mode (mode IV) is progressed. am.

8 (b) and (c), as in FIG. It is a program in which sleep mode (mode IV) is progressed.

8 (b) and (c), a buffer mode (mode 0) using tACS is performed at the beginning of the program.

When the main mode consists of two or more modes selected from memory improvement mode (mode I), concentration improvement mode (mode II), simultaneous improvement of memory and concentration mode (mode III), and sleep mode (mode IV), each mode A buffer mode (mode 0) may be located in between to relieve the tension of the person being treated.

If the electrode modules 111 to 117 include wet pads, moisture in the wet pads may evaporate with body temperature during use, resulting in an increase in impedance. Therefore, even during the period in which the main mode is performed, the control unit 140 performs the same operation as the check mode. In this way, it is possible to periodically check whether or not each of the electrode modules 111 to 117 is abnormal.

The controller 140 may use the sensor module 130 to measure changes in the electrocardiogram of the person to be treated according to the performance of the buffer mode (mode 0). In the main mode using tDCS, the patient's tension rises due to the pain caused by the electrical stimulation, which causes changes in the electrocardiogram. While performing the buffer mode (mode 0), the controller 140 detects changes in the electrocardiogram of the person to be treated and starts a scheduled main mode when the electrocardiogram is determined to be in a normal state. The electrocardiogram in a normal state means an electrocardiogram measurement value of the subject in a comfortable state, and can be determined based on heart rate or rhythm.

Each mode constituting the program is usually performed for 10 to 30 minutes, but it can be performed within 1 hour if necessary, and the intensity is determined within -5 mA to +5 mA. On the other hand, in the case of tACS, the amplitude can be controlled within -1mA to +1mA.

As shown in FIG. 8 (c), the buffer mode (mode 0) allows the amplitude to gradually increase over time so that the skin of the person to be treated more smoothly adapts to the stimulus.

The brain electrical stimulation protocol and program of the non-invasive brain stimulation device of the present invention may be implemented as a program (or application) including an executable algorithm that can be executed on a computer. The program may be stored and provided in a non-transitory computer readable medium. A non-transitory readable medium is not a medium that stores data for a short moment, such as a register, cache, or memory, but a medium that stores data semi-permanently and can be read by a device. Specifically, the various applications or programs described above may be stored and provided in a non-transitory readable medium such as a CD, DVD, hard disk, Blu-ray disk, USB, memory card, or ROM.

The non-invasive stimulator according to an embodiment of the present invention may be implemented in the form of a helmet as shown in FIGS. 9a and 9b. 9a and 9b are views showing a helmet with a built-in non-invasive stimulator according to an embodiment of the present invention from various angles. Figure 9a is a perspective view of the helmet body viewed from the upper left, and Figure 9b is a bottom view showing the inside of the helmet body in the wearing direction.

Referring to FIGS. 9A and 9B , the non-invasive stimulation device 100 includes a helmet body 210, an adhesion band 230 disposed on an inner surface of the helmet body 210, an adhesion band 230 and the helmet body 210. ) and a dial 240 for tightening or loosening at least one electrode module (111 to 117) and the close-fitting band 230 disposed in a distributed manner.

The helmet body 210 includes a bottom opening set to a size larger than the head of the person to be treated, and is manufactured in a form that covers the person to be treated from the forehead to the back of the head. One or

more electrode modules

113 and 114 may be movably coupled to the upper inner surface of the helmet body 210 . The upper central portion of the helmet body 210 may include a bridge portion 211 . Openings on both sides of the bridge portion 211 may be formed at the top of the helmet body 210 .

Electrode modules

113 and 114 may be disposed on the inner surface of the bridge part 211 facing the head of the person to be treated. A circuit board on which a power supply unit 120, a control unit 140, and a communication module 150 are mounted is embedded in the circuit internal unit 220 disposed on one side of the helmet body 210, and a power button omitted from the drawings, An LED display unit for displaying an operating state of the invasive stimulation device 100, a USB port to which an external device or power is connected, etc. may be connected to the circuit board.

The adhesion band 230 is wound on the inner surface of the helmet body 210 facing the head of the person to be treated. The electrode modules 111 to 117 are fluidly dispersed in the contact band 230, the bridge part 211, and the seesaw support member omitted from the drawings to face each of the electric stimulation parts shown in FIGS. 2A and 2B. installed The diameter of the contact band 230 is increased or decreased in association with the dial 240 . One or more electrode modules, in particular, an electrode module that opposes the electric stimulation position of the forehead of the person to be treated may be coupled to the adhesion band 230 . Two or more electrode modules facing the back of the head and back of the neck of the person to be treated may be coupled to the seesaw support member.

As shown in FIGS. 10 to 12 , each of the electrode modules 111 to 117 includes a non-conductive silicon holder 11, a conductive silicon pad 13, a non-conductive silicon pillar 15, a metal pin ( 17), and an adhesion pad 20.

The non-conductive silicone holder 11, the conductive silicone pad 13, and the non-conductive silicone filler 15 may be molded of silicone synthetic rubber, which is easy to mold. Silicone synthetic rubber has excellent heat resistance and has very low resistance when mixed with carbon black, silver, or an equivalent conductive material.

The non-conductive silicon holder 11 has a container structure in which a circular band-shaped side wall surrounds a concave inner space. The central portion of the non-conductive silicon holder 11 includes a hole 11a into which the head portion 17a of the metal pin 17 is inserted.

The metal pin 17 includes a head portion 17a inserted into the hollow 11a on the concave inner surface of the non-conductive silicon holder 11, a stopper 17b vertically protruding from the outer side of the head portion 17a, and a head portion. It includes a neck portion 17c connected to the head portion 17a with a thickness smaller than that of the head portion 17a.

The conductive silicon pad 13 is evenly disposed on the concave inner surface of the non-conductive silicon holder 11 .

The non-conductive silicon pillar 15 is bonded to the conductive silicon pad 13 at the center of the concave inner surface of the non-conductive silicon holder 11 . The non-conductive silicon filler 15 is inserted into the hollow of the contact pad 20 to support the contact pad 20 .

The non-conductive silicon pillar 15 includes a wide flat plate portion 15a and a protruding portion 15c protruding from the lower surface of the flat plate portion 15a. The upper surface of the flat plate portion 15a includes one or more small protrusions 15b. The non-conductive silicon pillar 15 includes a hollow 15d. The hollow 15d penetrates the flat plate part 15a and penetrates a part of the protruding part 15a to a depth smaller than the height of the protruding part 15c. provides

The non-conductive silicon holder 11, the conductive silicon pad 13, the non-conductive silicon pillar 15, and the metal pin 17 can be simultaneously joined in the mold. For example, when the raw material for the conductive silicon pad 13 is injected into the mold while the separately manufactured non-conductive silicon holder 11, the non-conductive silicon filler 15, and the metal pin 17 are mounted in the mold, As shown in FIG. 11, components of the electrode module except for the contact pad 20 are combined in one process.

As shown in FIG. 11 , the thin neck portion 17c of the metal pin 17 is inserted into the hollow 15d of the non-conductive silicon pillar 15 . In a state where the neck portion 17c of the metal pin 17 is inserted into the hollow 15d of the non-conductive silicon pillar 15, the conductive silicon pad 13 is connected to the metal pin 17 and the non-conductive silicon pillar 15. filled in between When the contact pad 20 is a wet pad, a current path and moisture permeation may be diffused through the conductive silicon pad 13 filled between the non-conductive silicon filler 15 and the metal pin 17 .

The protrusion 15b protruding from the flat plate portion 15a of the non-conductive silicon filler 15 contacts the inner surface of the non-conductive silicon holder 11, and the inner surface of the non-conductive silicon holder 11 and the non-conductive silicon pillar 15 ) to secure a space between the flat plate parts 15a. The central portion of the conductive silicon pad 13 is filled in the space secured by the protrusion 15b and the hollow 15d.

The contact pad 20 may be made of a porous material that is easily compressed and restored, for example, a sponge, and may be used as a wet pad or a dry pad. The dry pad may be made of a multilayer hydrogel composite. The contact pad 20 includes a hollow into which the protruding portion 15c of the conductive silicon pillar 15 is inserted.

When the contact pad 20 is press-fitted into the conductive silicon pillar 15, as shown in FIG. inserted into the inner space. The non-conductive silicon pillar 15 fixes the contact pad 20 within the non-conductive silicon holder 11 . The thickness of the contact pad 20 is thicker than the sidewall of the non-conductive silicon holder 11 . Therefore, when the contact pad 20 is inserted into the non-conductive silicon holder 11, the contact pad 20 may protrude outward by d1 as shown in FIG. 12 and adhere to the head of the person to be treated.

The height of the protruding portion 15c of the non-conductive silicon pillar 15 is greater than the thickness of the contact pad 20 . Accordingly, in a state where the contact pad 20 is press-fitted into the conductive silicon pillar 15, the protruding portion 15c of the non-conductive silicon pillar 15 protrudes from the contact pad 20 by d2 as shown in FIG. 12 . During electrical stimulation, due to overheating of the central part of the contact pad 20, the subject may feel hot, and a burning phenomenon may occur on the scalp. The non-conductive silicon filler 15 secures a space between the contact pad 20 and the skin of the person to be treated at the center of the contact pad 20 to lower the level of contact, thereby preventing a burning phenomenon.

Among the electrode modules 111 to 117 , one or more electrode modules facing the front of the head of the subject are coupled to the adhesive band 230 in a flexible manner. Two or more of the two or

more electrode modules

115 , 116 , and 117 facing the back of the head and back of the neck of the person to be treated may be movably connected to a seesaw support member coupled to the helmet body 210 .

The electrode modules 111 to 117 are connected to the tight band 230 or the seesaw support member with a snap button structure, or the tight band ( 230) or may be connected to the seesaw support member.

Referring to FIGS. 13 and 14 , a metal cap 19 may be coupled to the central portion of the rear surface of the non-conductive silicon holder 11 . The screw 22 is coupled to the female screw formed in the hollow of the metal cap 19 and the head of the metal pin 17 to fix the metal cap 19 to the central portion of the rear surface of the non-conductive silicon holder 11 . The metal cap 19 may be coupled to the magnet 24 installed on the adhesive band 230 or the seesaw support member. In FIG. 14, reference numeral “26” is a rubber ring that connects the electrode modules 111 to 117 to the contact band 230 or the seesaw support member in all directions in a flexible manner, and reference numeral “28” A wire connects the electrode modules 111 to 117 to the circuit board and applies a current from the circuit board to the electrode modules 111 to 117.

15 is a perspective view showing a coupling relationship between a dial, an adhesive band, a seesaw support member, and electrode modules. FIG. 16 is an enlarged view of part “A” in FIG. 15 . 17 is a view showing rotation of the seesaw support member. 18 is a partially cut-away perspective view showing a structure in which a seesaw support member is connected to a helmet body.

15 to 18, the non-invasive stimulation device 100 further includes a seesaw support member 50 rotatably connected to the helmet body 210.

The dial 240 and the close band 230 may be coupled in a rack and pinion coupling structure as shown in FIGS. 15 and 16 . For example, the dial 240 includes a thread of a pinion gear 241 protruding from within the helmet body 210 . Both ends of the contact band 230 include threads of rack gears 231 and 233. The rack gears 231 and 232 at both ends of the close band 230 are meshed with opposite threads of the pinion gear 241. Therefore, when the dial 240 is rotated in a loosening direction, for example, counterclockwise, the diameter of the contact band 230 is expanded, whereas when the dial 240 is rotated in a tightening direction, for example, clockwise, the contact band ( 203) is tightened and its diameter decreases.

The seesaw support member 50 is preferably made of a rigid material so that the

electrode modules

115, 116, and 117 can be closely attached to the head of the person to be treated. On the other hand, at least a portion of the adhesion band 240 may include a soft material so that it can be wound around the inner surface of the helmet body 210 .

The seesaw support member 50 is connected to the helmet body 210 through a hinge 51 providing a rotation axis, so that when one side is moved in one direction like the movement of the seesaw, the other side opposite to the rotation axis around the rotation axis is moved in the opposite direction.

A spring providing restoring force to the seesaw support member 50, for example, a torsion spring 53 as shown in FIG. When no external force is applied to the seesaw support member 50, the lower branch under the hinge 51 in the seesaw support member 50 moves far back from the helmet body 210 due to the restoring force of the torsion spring 53. is retreating When the person to be treated wears the fitness body 210, the upper branch portion on the hinge 51 of the seesaw support member 50 is retracted by the head of the person to be treated in the wearing direction, while the lower branch portion advances toward the person to be treated. At this time, all of the

electrode modules

115, 116, and 117 coupled to the seesaw support member 50 are strongly adhered to the back of the head and back of the neck of the person to be treated.

Two or

more electrode modules

115 , 116 , and 117 may be coupled to the seesaw support member 50 with the hinge 51 of the seesaw support member 50 interposed therebetween. Three

electrode modules

115, 116, and 117 may be connected to the seesaw support member 50, but are not limited thereto. For example, one or more electronic modules may be coupled above the rotational center of the seesaw support member 50, that is, the hinge 51, and one or more electronic modules may be coupled below the rotational center. In addition, the sensor module 130 may be further coupled to the seesaw support member 50 .

The seesaw support member 50 may be manufactured in a bent 'T' shape, for example, a structure surrounding the back of the subject's head and neck. When the three

electrode modules

115, 116, and 117 are coupled to the seesaw support member 50, the seesaw support member 50 extends from the top of the hinge 51 in the first direction Dir1 to form a fifth electrode module. A first upper branch supporting the 115, a second upper branch extending in the second direction Dir2 from above the hinge 51 and supporting the sixth electrode module 116, and a hinge 51 from below It may include a lower branch portion extending in the third direction Dir3 and supporting the seventh electrode module 117 . The sensor module 130 together with the seventh electrode module 117 may be further disposed on the lower branch of the seesaw support member 50, or the sensor module 130 may be disposed without the electrode module.

As shown in FIG. 18, a guide groove 212 accommodating the upper support portion of the seesaw support member 50 and the

electrode modules

115 and 116 coupled to the upper support portion is formed on the inner surface of the helmet body 210. can The top branch portion above the hinge 51 of the seesaw support member 50 may be inserted into the inner surface of the helmet body 210 when the person being treated wears the helmet body 210 .

When a person to be treated wears the helmet body 210 , the upper end support portion of the seesaw support member 50 may be retracted into the guide groove 212 and rotated slightly at the same time. To this end, the width (W) and length (L) of the guide groove 212 are preferably designed to be larger than the size of the

electrode modules

115 and 116 coupled to the upper support portion. For example, since the electrode module moves more in the longitudinal direction parallel to the wearing direction of the person to be treated, in consideration of this, the length (L) of the guide groove 212 is greater than the diameter of the electrode module and the width (W) of the guide groove 212 set larger than The width W of the guide groove 212 is greater than the diameters of the

electrode modules

115 and 116 .

19A to 19C are diagrams showing the state of the seesaw support member before the operator wears the helmet in which the non-invasive stimulator is embedded. 20A to 20C are diagrams showing a state of a seesaw support member before a person to be operated on wears a helmet in which a non-invasive stimulator is embedded.

Before the operator wears the helmet body 210, the seesaw support member 50 is in a state in which the upper branch portion is advanced forward than the lower branch portion by the restoring force of the torsion spring 53 as shown in FIGS. 19A to 19C. Therefore, the person to be treated can wear the helmet body 210 on the head without significant interference of the seesaw support member 50 .

While the person to be treated is wearing the helmet body 210 , the head of the person to be treated pushes the upper branch portion of the seesaw support member 50 . At this time, as shown in FIGS. 20A to 20C , the seesaw support member 50 rotates around the hinge 51 so that the upper branch of the seesaw support member 50 moves through the guide groove 212 of the helmet body 210. At the same time as retracting toward the side, the lower branch of the seesaw support member 50 advances toward the head of the person to be operated on, so that the seesaw support member 50 comes into contact with the back of the head or back of the neck of the person to be operated on. In this state, when the operator himself or the medical staff turns the dial 240 in the tightening direction, the contact band 230 is tightened, and all the electrode modules 111 to 117 coupled to the contact band 230 and the seesaw support member 50 It adheres to the head of the subject at the same time. In this state, electrical stimulation may proceed.

In the non-invasive stimulation device of the present invention, a plurality of electrode modules are disposed so that electrical stimulation can be simultaneously applied to a plurality of stimulation sites based on a diagnosis result of a patient. In particular, since the helmet with a built-in non-invasive stimulator according to an embodiment of the present invention can directly and simultaneously stimulate a plurality of areas with abnormal brain function, symptoms can be alleviated and treatment effects can be improved.

Since the content of the specification described in the problem to be solved, the problem solution, and the effect above does not specify the essential features of the claim, the scope of the claim is not limited by the matters described in the content of the specification.

Although the embodiments of the present invention have been described in more detail with reference to the accompanying drawings, the present invention is not necessarily limited to these embodiments, and may be variously modified and implemented without departing from the technical spirit of the present invention. . Therefore, the embodiments disclosed in the present invention are not intended to limit the technical idea of the present invention, but to explain, and the scope of the technical idea of the present invention is not limited by these embodiments. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. The protection scope of the present invention should be construed according to the claims, and all technical ideas within the equivalent range should be construed as being included in the scope of the present invention.

Claims

helmet body 210;

a seesaw support member 50 coupled to one side of the helmet body through a hinge and including at least one upper branch portion extending above the hinge, and a lower branch portion connected below the hinge;

one or more electrode modules 115 and 116 coupled to upper branches of the seesaw support member; and

One or more electrode modules 117 coupled to the lower branch of the seesaw support member,

In a state in which the upper branch of the seesaw support member is advanced, the lower branch is retracted toward the helmet body, and when the upper branch is retracted, the seesaw support member rotates around the hinge to advance the lower branch Invasive stimulation device.
According to claim 1,

Further comprising a torsion spring 53 connected between the hinge 51 of the seesaw support member and the helmet body,

A non-invasive stimulation device in which the upper branch of the seesaw support member advances and the lower branch maintains a retracted state when no external force is applied to the seesaw support member.
According to claim 1,

Adhesion band 230 wound on the inner surface of the helmet body;

a dial 240 coupled to the close-fitting band; and

Further comprising one or more electrode modules 111 and 113 coupled to the close band,

When the dial 240 is rotated in the tightening direction, the electrode modules coupled to the contact band and the seesaw support member are in close contact with the head of the person to be treated at the same time.
According to claim 3,

Each of the electrode modules 111 to 117,

a container-shaped non-conductive silicon holder 11 including an inner space defined by side walls;

a conductive silicon pad (13) disposed in an inner space of the non-conductive silicon holder;

an adhesion pad 20 disposed on the conductive silicon pad and exposed to the outside; and

a metal pin 17 inserted into the hollow of the non-conductive silicon holder and the hollow of the conductive silicon pad 13; and

Non-invasive stimulation device comprising a non-conductive silicon pillar 15 covering the hollow portion of the conductive silicon pad into which the metal pin is inserted and protruding over the surface of the contact pad through the hollow of the contact pad.
According to claim 4,

The non-conductive silicon filler,

flat plate portion 15a; and

Including a protrusion (15c) protruding from the lower surface of the flat plate,

The upper surface of the flat plate part 15a,

Including one or more protrusions (15b) protruding toward the inner surface of the non-conductive silicon holder,

A non-invasive stimulation device in which a portion of the conductive silicon pad is filled between the non-conductive silicon filler and the metal pin.
According to claim 4,

The contact pad protrudes from the upper end of the sidewall of the non-conductive silicon holder by a predetermined first distance,

A non-invasive stimulation device in which the upper end of the protrusion of the non-conductive silicon pillar protrudes from the contact pad by a second distance.
According to claim 1,

The seesaw support member,

Non-invasive stimulation device further comprising a sensor module 130 disposed on the lower branch portion.
A helmet body 210 having an open bottom surface;

Adhesion band 230 wound on the inner surface of the helmet body;

a dial 240 coupled to the contact band and adjusting the diameter of the contact fan in the direction of rotation;

first and second electrode modules 111 and 112 coupled to the contact band;

third and fourth electrode modules 113 and 114 coupled to an upper inner surface of the helmet body;

A seesaw support member 50 coupled to one side of the helmet body through a hinge, seesaw movement in conjunction with the head of the person to be treated, and having an upper support portion above the hinge and a lower support portion below the hinge;

one or more electrode modules 115 and 116 coupled to upper branches of the seesaw support member; and

Non-invasive stimulation device including at least one of an electrode module 117 and a sensor module 130 coupled to the lower branch of the seesaw support member.