JP7051734B2 - Headset for treatment and evaluation of medical conditions - Google Patents

Description

The present invention assesses devices and methods for applying electrical stimuli to the head region, headsets with electrodes for treating medical conditions using non-invasive electrical stimuli, medical conditions. With respect to adapted headsets, as well as electrode placement configurations used with such headsets.

According to some of the teachings of the present invention, there is provided a headset used to deliver an electrical stimulus to the skin surface of the user's head. The headset is (a) an outer peripheral headset body, the body having a monolithic frame fitted along the outer circumference of the user's head, the body being fitted to be connected to a power source. Containing electrical circuits, the headset body comprises an elastic placement configuration located on at least a portion of the outer circumference of the headset body, the elastic placement configuration adapted to extend along the outer circumference. An outer peripheral headset body and (b) at least one electrode base mechanically and at least semi-rigidly connected to the headset body, the electrode base being electrically associated with an electrical circuit and the electrode base being at least. Featuring an electrode base adapted to receive one electrode pad, the headset body and base are adapted and elastic to orient the electrically stimulating surface of the pad towards the skin surface when worn by the user. The placement configuration is adapted so that when worn, the elastic placement configuration urges the electrode base radially to the skin surface and the electrode pads are in physical and electrical contact with the skin surface, and the elastic placement configuration and electrode base are Due to the variable extension of the elastic arrangement configuration, the outer peripheral position with respect to the frame of the electrode base is adapted to be fixed at the intrinsic position.

According to another aspect of the invention, an electrode pad is provided. The electrode pads are (a) a water absorption layer with a biocompatible conductive contact surface, the contact surface adapted to juxtapose the skin surface, and (b) a wide range attached to the water absorption layer. A conductive layer having a first surface, wherein the conductive layer comprises a carbon foil or a carbon film, and the conductive layer draws current from a wide second surface distal to the first surface. It includes a first surface forming an integral structure, a water absorbing layer and a conductive layer adapted to move to the water absorbing layer via the conductive layer.

According to yet another aspect of the invention, an electrode base is provided. The electrode base is a housing comprising (a) a floor and a flexible outer peripheral member surrounding the floor, generally having a flexible outer wall extending above the peripheral edge of the floor, wherein the wall is an outer peripheral. Conductive placed at least above or inside the housing and (b) floor, terminated at the rim and the floor and flexible perimeter members form a cavity adapted to receive the conductive electrode pads. A material, the conductive layer is adapted to be electrically associated with an electrical circuit by a conductor, and when the pad is inserted, is adapted to electrically communicate with the electrode pad in mode of operation, the rim. And the flexible outer wall, when the pressure applied to the electrode base is applied towards the user's skin surface approximately perpendicular to the rim, the rim is urged to the skin surface to create a cavity and atmosphere or It has a conductive material that is adapted to be substantially fluid sealed to and from the external environment.

である。
Ａは、線および凹面によって境界を定められた領域であり、Ｌは、境界点間の線の長さであり、長さ（Ｌ）は少なくとも１０ｍｍであり、凹状の外形上の第１の点と凹状の外形の反対側の側上の周縁上の第２の点との間に線が配置され、第１の点において外形に対して垂直に整列され、長さＨを有し、凹状の外形の全体において、

であり、
Ｈ_ｍａｘは、全体におけるＨの最大値であり、
Ｈ_ｍｉｎは、全体におけるＨの最小値である。 Yet another aspect of the invention provides a biocompatible electrode juxtaposed to the user's skin surface. The electrodes are (a) a water absorbing layer having a biocompatible contact surface, the contact surface being attached to (b) a water absorbing layer adapted to be juxtaposed on the skin surface and (b) a water absorbing layer. An electrode support that is provided, the support comprising at least one conductive material or element, the conductive material or element having a water absorbing layer and electricity in mode of operation when the water absorbing layer is filled with water. It is provided with an electrode support portion which is connected to the object. The biocompatible contact surface has (i) a long portion ( _{DL) having a maximum length of 20 mm to 55 mm and (ii) a short portion (DN )} having a maximum length of 10 mm to 25 mm. However, the first side of the periphery of the biocompatible contact surface has a concave surface defined by a first boundary point and a second boundary point located at the opposite ends of the concave surface (or concave) . It has a concave outer shape and has a concave shape.

Is.
A is a region bounded by lines and concave surfaces, L is the length of the line between the boundary points, the length (L) is at least 10 mm, and the first point on the concave outer shape. A line is placed between and a second point on the periphery on the opposite side of the concave outer shape, aligned perpendicular to the outer shape at the first point, having a length H, and concave. In the whole outline,

And
H _max is the maximum value of H in the whole,
H _min is the minimum value of H in the whole.

According to yet another aspect of the invention, there is provided a method of wearing and placing the headset on the user's head, as substantially described herein.

According to a further feature of the preferred embodiment described, the outer peripheral headset body has an anterior portion adapted along the perimeter of the anterior portion of the head and at least one electrode base is located on the anterior portion. It is a front electrode base.

According to a further feature of the preferred embodiment described, the front portion is a front mechanical element that is physically different from the outer peripheral headset body.

According to further features in the preferred embodiments described, the anterior mechanical element spans up to 40%, up to 35%, up to 30% or up to 20% of the outer circumference of the outer peripheral headset body.

According to further features in the preferred embodiments described, the anterior mechanical element is 10% -40%, 15% -40%, 20% -40%, 25% -40% or 25 of the outer circumference of the outer peripheral headset body. It ranges from% to 35%.

According to a further feature of the preferred embodiment described, the peripheral headset body has a rear portion adapted along the perimeter of the posterior portion of the head and at least one electrode base is located on the posterior portion. A rear electrode base is provided.

According to a further feature of the preferred embodiment described, the rear portion is a rear mechanical element that is physically different from the outer peripheral headset body.

According to further features in the preferred embodiments described, the rear mechanical elements span up to 40%, up to 35%, up to 30% or up to 20% of the outer circumference of the outer peripheral headset body. According to further features in the preferred embodiments described, the rear mechanical element is 10% -40%, 15% -40%, 20% -40%, 25% -40% or 25 of the outer circumference of the outer peripheral headset body. It ranges from% to 35%.

According to further features in the preferred embodiments described, the anterior and posterior mechanical elements generally range from 45% to 75%, 50% to 75%, 55% to 75% or 55% to 70% of the outer circumference. ..

According to a further feature of the preferred embodiment described, the frame comprises at least semi-rigid side components bilaterally arranged on the frame to form the outer peripheral sides of the headset body.

According to further features in the preferred embodiments described, the lateral components are generally 15% -50%, 20% -50%, 25% -50%, 30% -50%, 35 of the outer circumference. It ranges from% to 50% or 30% to 45%.

According to a further feature of the preferred embodiment described, each side component has an element that is located approximately perpendicular to the outer circumference and that is fitted along the back of the user's ear in wearing mode. ..

According to a further feature in the preferred embodiments described, the outer peripheral stiffness of the side components exceeds the outer peripheral stiffness of the front and rear portions.

According to a further feature in the preferred embodiments described, the outer perimeter elasticity of the anterior and posterior portions exceeds the outer perimeter elasticity of the side components.

According to a further feature of the preferred embodiment described, the frame comprises a positioning system for angular and longitudinal positioning of the headset body, the positioning system having at least one at least semi-rigid side component. Be prepared. The side components form part of the perimeter and are approximately perpendicular to the elongated element with the first elongated element fitted along above the user's ear to determine longitudinal positioning. With a second element arranged along the back of the ear to determine the angular positioning of the headset body.

According to a further feature of the preferred embodiment described, the frame comprises at least a first symmetrical size adjustment mechanism adapted to fix the outer circumference of the headset body.

According to the further features of the preferred embodiments described, the adjusting mechanism is rigid or at least semi-rigid.

According to a further feature of the preferred embodiment described, the frame comprises a first symmetrical size adjustment mechanism and a second symmetrical size adjustment mechanism adapted to adjust the outer circumference of the headset body. .. The first adjustment mechanism connects the side components to the front and the second adjustment mechanism connects the side components to the rear.

According to a further feature of the preferred embodiment described, the first adjustment mechanism and the second adjustment mechanism can adjust the outer circumference of the headset body while the outer peripheral position of the side component is fixed. Is adapted to.

According to a further feature in the preferred embodiments described, the frame is such that the frame is substantially inelastic along at least 30%, at least 40%, at least 50% or at least 60% of the outer peripheral length. Is adapted to.

According to a further feature in the preferred embodiments described, the headset body is adapted to juxtapose the contact surface of the electrical device with the skin surface, and the elastic placement configuration radially urges the electrical device to the skin surface. The contact surface of the electrical device is then adapted to make physical contact with the skin surface, and the elastic placement configuration is such that the outer peripheral position of the electrical device is fixed at its own position due to the variable stretching of the elastic placement configuration. It is adapted.

According to a further feature of the preferred embodiment described, the electrical device comprises a sensor adapted to sense the parameters associated with the user's head.

According to a further feature in the preferred embodiment described, the water absorbing layer of the electrode pad comprises at least one material selected from the group consisting of non-woven fabrics, felts or sponges.

According to a further feature of the preferred embodiment described, the conductive layer has a conductive layer that is more conductive than most of the conductive layer on a second surface distal to the water absorbing layer. , This highly conductive layer is typically a conductive paint and is preferably arranged in a mesh pattern.
According to a further feature of the preferred embodiment described, the water absorbing layer and the conductive layer have a layer of conductive paint forming an integral structure.

According to the further features of the preferred embodiments described, the conductive carbon film or carbon foil has a resistance of 1 to 180 Ω / □ or 30 to 100 Ω / □.

According to further features in the preferred embodiments described, the conductive carbon film or carbon foil has a thickness in the range of 30-1500 microns or 50-200 microns.

According to a further feature of the preferred embodiment described, on the rim of the electrode base, a plurality of encapsulating fingers having a volume are arranged in the circumferential direction, and the encapsulating fingers urge the rim to the skin surface. And a plurality of sealing fingers are adapted to substantially seal between the volume and the volume outside the sealing finger.

According to a further feature of the preferred embodiment described, the rim comprises or consists of a plurality of encapsulating fingers arranged in the circumferential direction, essentially consisting of a plurality of encapsulating fingers and encapsulating. The fingers are approximately perpendicular to the electrode base floor or skin surface when pressure is applied so that multiple sealing fingers effectively seal between the cavity and the outer volume of the rim. Is adapted to.

According to further features in the preferred embodiments described, the ratio A / L of the electrode arrangement configuration is at least 0.2 mm, at least 0.5 mm, at least 0.7 mm, at least 1 mm, at least 1.5 mm or at least 1.7 mm. Is.

According to further features in the preferred embodiments described, the length (L) is at least 12 mm, at least 15 mm, at least 18 mm or at least 20 mm.

According to a further feature of the preferred embodiment described, the electrode arrangement configuration further comprises an electrode pad.

According to a further feature of the preferred embodiment described, the inner surface of the flexible outer wall has a radial curvature and is radial between the inner surface of the rim and the innermost point in the radial direction of the inner surface of the wall. The distance is at least 1 mm, at least 3 mm, at least 5 mm or at least 10 mm.

According to further features in the preferred embodiments described, this radial distance is in the range of 1-15 mm, 2 mm-12 mm, 2 mm-10 mm or 2 mm-7 mm.

According to a further feature in the preferred embodiment described, the outer surface of the flexible outer wall has a radial curvature and the length of the curvature of the outer surface is at least 1 mm, at least 2 mm, at least 3 mm or at least 5 mm.

According to further features in the preferred embodiments described, the length of curvature of this outer surface ranges from 1 mm to 15 mm, 2 mm to 10 mm or 3 mm to 8 mm.

According to a further feature of the preferred embodiment described, the electrode arrangement configuration further comprises a pressure arrangement configuration. The pressurized arrangement configuration is mechanically associated with the electrode base and is adapted to deliver pressure to the electrode base approximately perpendicular to the rim.

According to a further feature of the preferred embodiment described, the electrical device comprises a transmission arrangement configuration adapted to transmit a signal from the sensor.

According to a further feature of the preferred embodiment described, the electrode base housing comprises a flexible bellows type member.

According to a further feature of the preferred embodiment described, the electrode base housing comprises a liquid capture and storage arrangement configuration.

In the present specification, the present invention will be described with reference to the accompanying drawings solely for the purpose of illustration. The details described herein with particular reference to the drawings are exemplary and are solely for illustrative purposes of preferred embodiments of the invention, the principles and conceptual embodiments of the invention. It is emphasized that it is presented to provide what is considered to be the most useful and easy-to-understand description of. In this regard, it is not intended to show the structural details of the present invention in more detail beyond the level necessary for a basic understanding of the present invention, and it is intended to embody some embodiments of the present invention. It is emphasized that the statements shown with the drawings to show to those skilled in the art may actually be embodied. Throughout the drawings, similar reference numerals are used to indicate similar functions, but do not necessarily indicate the same elements.

It is a perspective view of one Embodiment of the headset of this invention placed on the head of a user. It is a perspective view of one Embodiment of the headset of this invention placed on the head of a user. It is a perspective view of one Embodiment of the headset of this invention. It is a side view of the headset of this invention placed on the head of a user. It is a side view of the headset of this invention placed on the head of a user. It is a side view of a part of the headset of this invention which has a branch type rear elastic member for improving the stability of a headset. It is a perspective view of the headset of this invention which has a posterior elastic member which does not include an electrode. It is a perspective view of the electrode base arrangement structure of this invention and the elastic member accommodating this arrangement structure by one Embodiment of this invention. It is a perspective view of the electrode base arrangement structure of this invention and the elastic member accommodating this arrangement structure by one Embodiment of this invention. It is a perspective view of the electrode base arrangement composition of this invention by a specific embodiment of this invention. It is a perspective view which shows the elastic member shown in FIG. 7A together with the cross section in the intermediate part. FIG. 7 is a cross-sectional view of the electrode base of FIG. 7 connected to the inside of the elastic member of FIG. 7A. FIG. 9 is a perspective view of the structure of the present invention shown in FIG. The adjustable electrode base arrangement configuration of the present invention for adjusting the distance between an adjacent electrode base housing and three different positionings of these electrode base housings is shown. The adjustable electrode base arrangement configuration of the present invention for adjusting the distance between an adjacent electrode base housing and three different positionings of these electrode base housings is shown. The adjustable electrode base arrangement configuration of the present invention for adjusting the distance between an adjacent electrode base housing and three different positionings of these electrode base housings is shown. 11A-11C are perspective views of an elastic member accommodating this adjustable electrode base arrangement configuration. An adjustable electrode-based housing arrangement according to an embodiment of the present invention and an elastic member accommodating this arrangement are shown. An adjustable electrode-based housing arrangement according to an embodiment of the present invention and an elastic member accommodating this arrangement are shown. It is sectional drawing of the electrode pad arranged on the electrode base. FIG. 3 is a perspective view of an electrode base (FIG. 15A) having a multilayer electrode pad and an electrode base not including the multi-layer electrode pad (FIG. 15B) according to the present invention. FIG. 3 is a perspective view of an electrode base (FIG. 15A) having a multilayer electrode pad and an electrode base not including the multi-layer electrode pad (FIG. 15B) according to the present invention. It is sectional drawing and bottom view of this multilayer electrode pad. It is sectional drawing and bottom view of this multilayer electrode pad. FIG. 3 is a cross-sectional view of an electrode base assembly in which a specific electrode pad structure is internally connected to an electrode base housing according to various embodiments of the present invention. FIG. 3 is a cross-sectional view of an electrode base assembly in which a specific electrode pad structure is internally connected to an electrode base housing according to various embodiments of the present invention. FIG. 3 is a cross-sectional view of an electrode base assembly in which a specific electrode pad structure is internally connected to an electrode base housing according to various embodiments of the present invention. FIG. 3 is a cross-sectional view of an electrode base assembly in which a specific electrode pad structure is internally connected to an electrode base housing according to various embodiments of the present invention. FIG. 3 is a cross-sectional view of an electrode base assembly in which a specific electrode pad structure is internally connected to an electrode base housing according to various embodiments of the present invention. It is sectional drawing of each electrode pad shown in FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. 20A. It is sectional drawing of each electrode pad shown in FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. 20A. It is sectional drawing of each electrode pad shown in FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. 20A. It is sectional drawing of each electrode pad shown in FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. 20A. It is sectional drawing of each electrode pad shown in FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. 20A. FIG. 3 is a perspective view of an electrode base housing to which a spring with an electrode pad is attached. It is a perspective view and sectional view of the electrode pad and the bellows type electrode base housing by embodiment of this invention. It is a perspective view and sectional view of the electrode pad and the bellows type electrode base housing by embodiment of this invention. It is a perspective view and sectional view of the electrode pad and the crushing type electrode base housing by embodiment of this invention. It is a perspective view and sectional view of the electrode pad and the crushing type electrode base housing by embodiment of this invention. It is a perspective view of the electrode base housing of this invention which has an outer peripheral sealing rim. It is sectional drawing of the electrode base housing shown in FIG. 22, and the housing has an electrode pad arranged inside. FIG. 22 is a cross-sectional view of the electrode base housing and the electrode pad shown in FIG. 22, in which the electrode pad is urged to the skin surface. It is sectional drawing of the electrode base in which the wall geometry is defined inside. It is sectional drawing of the electrode base housing of this invention provided with an electrode pad, and the electrode pad is urged to the skin surface. FIG. 25A is a cross-sectional view of the housing and pad arrangement configuration of FIG. 25A in relaxation mode, defining wall geometry. It is a perspective view of the electrode base housing of the present invention provided with an electrode pad, the housing comprising a plurality of closely arranged sealing fingers surrounding the electrode pad in the circumferential direction. FIG. 25C is a cross-sectional view of the housing and pad arrangement configuration of FIG. 25C. FIG. 25C is a top view of the housing and pad arrangement configuration of FIG. 25C. It is a cross section of the housing and pad arrangement configuration of the present invention in which the curvature of the housing wall is adapted to capture excess fluid. It is a perspective sectional view of the headset of one Embodiment of this invention placed on the head of a user. It is an enlarged view of the electrode base housing urged to the head. FIG. 3 is a perspective view of a flexible comb-shaped member arranged above the electrode base housing according to an embodiment of the present invention. FIG. 26 is a perspective rear view of the wearing headset in which the flexible comb-shaped member of FIG. 26 projects above the outer peripheral band of the headset. It is a perspective front view of a wearing headset according to an embodiment of the present invention, and the configuration of the headset and the adaptation and placement of the anterior electrodes are performed so as to stimulate a specific nerve branch in the forehead region. The dimensions of the electrodes of the invention configured to selectively stimulate nerve branches within the supraorbital region are shown. It is a perspective rear view of a wearing headset according to an embodiment of the present invention, and the configuration of the headset and the adaptation and placement of the posterior electrodes are performed so as to stimulate a specific nerve branch in the occipital nerve region. It is a side perspective view of the symmetrical member of the headset of this invention by one Embodiment of this invention. It is a perspective view of the headset of this invention attached. It is a perspective front view of the headset of this invention attached with a nasal bridge support member. FIG. 3 is a perspective view of a headset of the present invention worn with eyeglasses associated with it. FIG. 3 is a perspective view of a headset of the present invention fitted with earphones associated with it. FIG. 3 is a perspective view of a headset of the present invention in a worn state adapted to communicate with a remote control unit, a mobile phone and a computer.

Described herein are devices and methods comprising a headset with one or more integrated electrodes for applying electrical stimuli to peripheral nerves, cranial nerves and brain regions. The headset of the present invention is a head-mounted structure and has various conditions (eg, migraine and tension headache, fibromyalgia, depression, post-traumatic stress syndrome, anxiety, obsessive-compulsive disorder). (OCD), insomnia, epilepsy, attention deficit hyperactivity disorder (ADHD), Parkinson's disease, Alzheimer's disease, multiple sclerosis, and stroke) can serve as a platform for applying electrical stimulation. can. The headset of the present invention can promote motor and cognitive learning and cause relaxation. The headset of the present invention can also function as a platform for various sensors for detecting and / or evaluating various conditions.

Contact between the stimulating electrode and the scalp of the stimulating electrode is a basic aspect of the function of the apparatus of the present invention. Optimal conduction between the electrodes and the scalp is essential for the proper transfer of current to the target tissue, which is the basis of effective treatment. Inadequate conductivity can result in treatment failures, discomfort and even skin irritation due to high current density "hot spots". In addition, the present inventors may have a number of problems when applying a current to the head region non-invasively, regardless of the target symptom of the current application (eg, hair). Stimulation in the presence of, high levels of hypersensitivity in the scalp and forehead, critical contact between electrodes and scalp and criticality of conductivity, above target nerves and brain regions regardless of changes in head size and shape It was also discovered that the exact placement of the stimulation electrodes).

Some aspects of the invention relate to the proper and reliable delivery of current from the electrodes to the target tissue and the effective and comfortable treatment and evaluation of the head region.

Referring to the drawings here, FIGS. 1 and 1A are perspective views of an embodiment of the headset system 10 of the present invention mounted on the head 5. In one embodiment, the headset 10 comprises an outer peripheral frame (“headset body”) which may include a rear elastic member 30, a front elastic member 40 and a symmetrical semi-rigid and preferably rigid member 50a. May be configured. The rear elastic member 30 may be connected to the symmetrical member 50a at the connection points 8 and 16. The front member 40 may be configured to be connected to the symmetrical member 50a at the connection points 14 and 18. The front member 40 may be configured to surround the forehead area 12. The posterior elastic member 30 may be configured to surround the occipital region 11. The intermediate symmetrical semi-rigid member 50a may be configured to be located behind and above the ear 16.

FIG. 2 is a perspective view of an embodiment of the headset system 10 of the present invention. The headset 10 may be configured to include an elastic rear member 30, an elastic anterior member 40 and a rigid and preferably semi-rigid symmetrical member 50a. The rear member 30 may be configured to be connected to an intermediate symmetrical member 50a by a size adjusting mechanism 32a, 32b configured to be disposed behind the ear. The anterior member 40 may be configured to be connected to a symmetrical intermediate member 50a by size adjusting mechanisms 42a, 42b configured to be arranged in front of the ears on both sides of the head.

Adjustments to the various head sizes of the headset 10 can be made by symmetrical anterior adjustment mechanisms 32a, 32b as well as posterior symmetrical adjustment mechanisms 42a, 42b. When the elastic members 30 and 40 are pulled away from the intermediate symmetrical member 50a or pushed toward the intermediate symmetrical member 50a, the size / outer circumference of the headset 10 is increased or decreased. According to certain embodiments, the intermediate symmetrical member 50a may be configured to be flexible to self-align with various head shapes.

The mechanism for adjusting the headset 10 to fit various head sizes may include only symmetrical anterior adjustment mechanisms 32a, 32b or symmetrical posterior adjustment mechanisms 42a, 42b.

In some embodiments, both the anterior adjustment mechanisms 32a, 32b and the posterior adjustment mechanisms 42a, 42b can improve headset adjustment while maintaining a symmetrical arrangement of the headset on the head. In addition, this allows for proper adjustment of the headset size while maintaining proper placement of the corresponding symmetrical member 50a behind the ear.

The rear member 30 and the anterior member 40 may be configured to include electrode bases (also referred to as electrode systems) 60, 70, respectively, and when in an extended state, a radial force is applied to the electrode base housing 150 to move it to the scalp. It is adapted to ensure electrical connections between the electrode pads 56a and the skin surface while minimizing unwanted pressure from the headset to the scalp.

The symmetrical member 50a in the middle may be configured to include an electronic circuit 52b. The electronic circuit 52b may be configured to be electrically connected to the battery 52a and the electrode units 60, 70 by the conductive wire 54.

The electronic circuit 56b may be configured to include a stimulating circuit, a microprocessor, a charging circuit and a user interface.

The stimulus circuit may be configured to generate a two-phase charge balanced electrical pulse, a single phase electrical pulse and / or a DC stimulus.

According to a further feature of the preferred embodiment described, the stimulus circuit may be configured to generate electrical stimuli within the intensity range 0-80 mA, 0-40 mA, 0-20 m or 0-15 mA.

According to a further feature of the preferred embodiment described, the stimulus circuit is such to generate a stimulus pulse with a duration of 10-600 μsec, 50-500 μsec, 100-500 μsec, 100-450 μsec, 150-400 μsec or 150-450 μsec. May be configured in.

According to a further feature of the preferred embodiment described, the stimulus circuit may be configured to generate stimulus pulses at frequencies of 1-500 Hz, 10-300 Hz, 10-250 Hz, 20-180 Hz or 30-180 Hz. ..

According to a further feature of the preferred embodiment described, the headset 10 may be configured to transfer current from an external stimulator to the headset electrode by connecting to external electrons and a stimulator circuit. The headset 10 may be configured to connect to at least one external electrode that may be located in various areas of the body. The headset 10 may be configured to connect to an external electronic circuit and processor to move the signal from its board sensor to an external processor.

The battery 52a can be recharged by inserting the charger into the charging port 770 arranged on the member 50a. The symmetrical member 50a may also be configured to include user control and an interface 750. In some embodiments, both symmetrical members may be configured to include a user interface 750. In some embodiments, other parts of the headset 10 of the invention (eg, front member 40 or rear member 30) may be configured to include a user interface 750.

In some embodiments of the invention, the elastic members 30 and 40 of the headset 10 together with the electrode pads 56a in stretch mode while minimizing unwanted pressure from the headset to the scalp in regions where the electrodes are not held. It may be configured to transfer a radial force to the electrode base housing 150 to ensure contact with the skin surface.

FIG. 3 is a side view of the headset 10. In some embodiments, the headset 10 is placed higher on the head while maintaining various characteristics (eg, precise placement, adjustment for different head sizes and electrode mounting). It may be configured as follows. Positioning the headset 10 higher on the head allows stimulation of other nerves and brain regions, positioning various sensors (eg, EEG sensors) higher on the head. Will also be possible.

According to another aspect of the invention, the headset 10 is configured to include a wider elastic member 40,30 along with a symmetrical member 56a that may be adapted to connect to a wider member 40,30. May be done. The wider members 40, 30 allow larger electrodes to be integrated into the headset 10 to stimulate larger regions (eg, regions for stimulation of various brain regions).

FIG. 4 is a side view of the headset 10 with an additional semi-rigid and preferably elastic member 590. The member 590 is configured to be vertically connected to the symmetrical member 56a, is arranged between the symmetrical members 56a, and is fitted to surround the upper part of the head. The elastic member 590 allows stimulation and positioning of electrodes and sensors at higher positions on the head.

FIG. 5 is a side view of the headset 10 configured to include a bifurcated posterior elastic member 30 to increase the stability of the headset 10 over the occipital region.

FIG. 6 is a perspective view of the headset 10, where the posterior elastic member 30 does not hold the electrodes and its main or sole function is to stabilize the headset 10 on the head.

When necessary, the anterior elastic member 40 may be configured to comprise an electrode and the posterior member 30 comprises an electrode.

FIG. 7 is a perspective view of the electrode base or the base arrangement configuration 60 of the present invention. FIG. 7A is a perspective view of the elastic member 30 accommodating the arrangement configuration 60 according to the embodiment of the present invention.

With reference to FIGS. 7 and 7A, the elastic member 30 is configured to be at least partially hollow to include the electrode base 60 and the conductive wire 54, and the elastic modulus of the headset is kept low. It is configured to help maintain a stable three-dimensional configuration. The elastic member 30 may be configured to include at least one opening 82 on the inside (opposing the skin surface). The electrode base 60 may be configured to include at least one housing 150. In one embodiment, the housing 150 is configured to be connected to an elongated flexible member 64. The electrode base 60 may be configured to be physically connected to the inside of the elastic member 30 such that the flexible connection band 84 is connected to the elastic member 30 at the connection site 64.

The elastic member 30 may have a lower modulus above the electrode base housing 150 as compared to a higher modulus within the other regions. The member 30 parallel to the lower surface of the housing 150, for example due to the configuration of the outer surface of the member 30 in a region where the lower coefficient is due to the opening 82 and in a region parallel to the opening 82 that is thinner than the other regions. May be achieved within the realm of. Thus, when the headset 10 is worn, a local radial force is applied from the member 30 onto the electrode base housing 150 towards the scalp. In contrast, the other regions of the elastic member 30 may be configured to have a higher modulus of elasticity and thus the diameter to the scalp in these regions so that extra pressure is avoided where it is not needed. Directional force is minimized. The region configured to have a higher modulus of elasticity can also help maintain the stable three-dimensional structure of the member 30 and the headset 10, which makes it easier and more accurate to place the electrodes. Is promoted.

8 and 8A are a perspective view of the electrode base 60 and a cross-sectional view of the elastic member 30 (shown in FIG. 7A), respectively. The elastic member 30 may be configured to include protrusions 96a, 96b to allow connection to the electrode base 60. The electrode base 60 may be configured to include holes 98a, 98b in a flexible connecting band 84. In order to physically connect the electrode base 60 and the elastic member 30, the electrode base 60 can be inserted into the elastic member 30 and the protrusions 96a and 96b can be snapped to the holes 98a and 98b. The physical connection may include other mechanisms. For example, the flexible member 68 can be adhered to the flexible member 30 at the connection portion 64.

FIG. 9 is a cross-sectional view of the electrode base 60 connected to the inside of the elastic member 30. The headset is mounted because the electrode base 60 can be integrated into the headset member 30 and the flexible connection band 84 can be physically connected to the elastic member 30 only at the connection portion 64. The member 30 can be stretched and moved to the scalp by applying a radial force to the electrode base housing 150 and the electrode pad 56a (without limitation by the electrode system 60). This arrangement also makes it possible to maintain a predetermined distance between the electrode base housings 150 when the headset member 30 is extended.

FIG. 10 shows a part of the headset member 30 according to one embodiment. While the electrode system 60 (partially hidden) is integrated within the member 30, only the electrode base housing 150 and the electrode pads 56a project through the openings 82a, 82b of the elastic member 30. The flexible connection band 84 and the connection site 64 are shown by dotted lines. The openings 82a, 82b exceed the intermediate edge of the electrode base housing 150 so that the extension of the member 30 is not restricted by the lateral extension of the openings 82a, 82b when the member 30 is extended. Can be extended.

11A to 11C are perspective views of the electrode base arrangement configuration of the present invention in which the distance between adjacent electrode base housings 150 can be preset. 11A-11C show three different preset positionings 60A-60C of these electrode base housings. 11D is a perspective view of an elastic member for accommodating this adjustable electrode base arrangement configuration shown in FIGS. 11A-11C.

According to the particular features of the preferred embodiments described, the position of the electrode base housing 150 can be adjusted to suit the various morphological and human body variables of the particular user. According to one embodiment, the electrode base units 60a, 60b, 60c may be configured to have a variable distance between the electrode base housings 150. It may be configured to be reversibly connected to the elastic member 30 by the holes 64 of the electrode system and the protrusions 96a, 96b (both hidden) on the elastic member 30. According to the specific features of the preferred embodiments described, the electrode base units 60a, 60b, 60c may be connected by other connection mechanisms.

12 and 13 show a mechanism for adjusting the arrangement of the electrode base housing 150 according to a further feature of the preferred embodiment described.

FIG. 12 is an internal view of the elastic member 30 according to one embodiment, in which the flexible connecting band 84 is connected to the member 30 by protrusions 96a and 96b (both hidden) extending from the member 30. It is snapped into the hole in the flexible connecting band 84. The mechanical connection of the flexible connecting band 84 and the elastic member 30 may be made by other mechanisms (eg, other snap connectors or gluing). According to one embodiment, the flexible connecting band 84 ranges from 0.5 to 5 cm (more typically 0.5 to 3 cm, 0.5 to 2 cm or 0.5 to 0.5) between each hole. Includes hole 98 at a distance (within a range of 1 cm).

FIG. 13 is a bottom view of a part of the electrode base 60. According to one embodiment, the electrode base housing 150 may be configured to include protrusions 92a, 92b generated from its lower surface. The protrusions 92a, 92b are configured to snap into any of the holes 98 in the flexible connecting band 84. The arrangement of the electrode base housing 60 can be adjusted by snapping the protrusions 92a, 92b into the other holes 98 in the flexible connecting band 84.

FIG. 14 is a cross section of the electrode pad 56a arranged in the electrode base 60. The electrode base 60 may be configured to be physically connected to the headset by an elongated flexible connecting band 84 and may be electrically connected to the headset electrical circuit by conductive wires 158. The electrode base 60 may be configured to include at least one electrode base housing 150 including a raised outer wall surrounding the "floor", thereby fitting to receive at least one conductive electrode pad 56a. The cavities that have been created are created. According to certain embodiments, the electrode base housing 150 is preferably constructed of a flexible material (eg, silicone or thermoplastic polyurethane resin (TPU)).

The electrode base housing 150 may be configured to include a conductive material 154 located partially above or within the electrode base housing 150 floor of the electrode base housing 150 floor. The conductive layer is adapted to be electrically connected to the electrical circuit by the conductor 158.

The conductive layer 154 may be configured to include materials such as, for example, stainless steel, copper, brass, silicon carbon, conductive silver paint prints, stainless mesh or other conductive elements. If the conductive layer 154 is made of carbon, an additional conductive paint layer may be printed on its lower surface. With such a conductive coating layer, the uniformity of the current distribution on the surface of the conductive layer 154 can be improved, and thereby the uniformity of the current distribution on the surface of the electrode pad 56a can be improved. .. The conductive layer 154 is preferably flexible so as not to compromise the overall flexibility of the electrode base 60, which ensures alignment with various head shapes. In certain embodiments, the conductive layer 154 can be confined within that region and may be configured to cover only part of the floor surface of the electrode base housing 150. In such a case, the conductive layer 154 does not have to be flexible and may be made of various conductive materials known to those skilled in the art. Since the conductive layer 154 can be configured to be electrically connected to the conductor (cable or wire) 158, it can be electrically connected to the headset electrical circuit.

The electrode pad 56a may be configured to be releasably connected to the electrode base housing 150 (physically and electrically). The electrode pad 56a may contain at least a portion of water or other liquid absorbent material (eg, non-woven fabric, felt or sponge). The user may immerse the electrode pad 56a in water or other liquid prior to use. When connected to the housing 150, the electrode pads 56a are configured to be in electrical contact with the conductive layer 154. When the headset is worn, the pad 56a is urged to the skin surface and can electrically contact the skin surface (skin surface including the scalp) to transfer current to the skin surface.

The electrode pad 56a and other electrodes associated with the headset receive (sensing) currents from the skin surface or other biological signals (eg, electroencephalograms (EEGs)) that are passed through the headset circuit to the microprocessor. It may be configured to be moved to an electronic circuit containing or transmitted wirelessly to a remote unit.

The electrode pad 56a may be a disposable type and can be easily replaced by the user.

The electrode pad 56a may be configured to include an edge portion 156 that is thinner than the central region of the pad 56a. The edge portion 156 may be configured by various manufacturing processes (eg, ultrasonic welding, RF welding or thermal compression). By inserting the thin edge 156 into the corresponding groove 152 in the housing 150, the electrode pad 56a can be reversibly physically connected to the housing 150 and electrically connected to the conductive layer 154.

The electrode pad 56a may be configured to have a larger area than the housing 150. Therefore, the electrode pad 56a can be pushed into the housing 150 and reversibly (physically and electrically) connected to the housing 150.

The electrode base housing 150 may be configured to include a conductive mechanical snap connector configured to be physically and electrically reversibly connected to a corresponding connector attached to the electrode pad 56a.

15A and 15B are perspective views of the electrode base 60 including the multilayer electrode pad 56a of the present invention and the electrode base 60 not including the multilayer electrode pad 56a of the present invention. 15C and 15D are a cross-sectional view and a bottom view of the multilayer electrode pad 56a. The multilayer electrode pad 56a may include a water absorbing layer 254 and a flexible conductive layer 258 preferably made of carbon foil. These two layers may be attached or may be attached directly. Various manufacturing processes are available (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). In order to reduce the current density at the edges of the liquid absorption layer 254, the conductive layer 258 may be configured to have a smaller area or "installation area" than the layer 254. As a result, the current density at the edges of layer 254 (which has lower conductivity with respect to layer 258) is reduced. The conductive layer 258 may further include a thin conductive layer 255 of the conductive paint. The conductive layer 255 may be printed in a "mesh" pattern and may be configured to cover only the central portion of layer 258. The conductive layer 255 may preferably be printed on the underside of layer 258 and is conductive in the electrode base housing 150 such that the multilayer electrode pad 56a is electrically connected when attached to the electrode base housing 150. It may be configured to face layer 154. The conductive printed layer 255 may be configured to have higher conductivity than layer 258, thereby reducing the current density at the edges of layer 258 (not including layer 255) while the current on layer 258. The dispersion is improved.

16A, 17A, 18A, 19A, 20A are cross-sectional views of an electrode base assembly in which a particular electrode pad structure is connected to an electrode base housing according to various embodiments of the present invention. 16B, 17B, 18B, 19B, and 20B are cross-sectional views of the electrode pads shown in FIGS. 16A, 17A, 18A, 19A, and 20A.

Here, referring to FIGS. 16A and 16B, the electrode pad 56a may include a liquid absorbing layer 254 and a "hook" (eg, Velcro®) fastening layer 252. Both layers can be attached by various manufacturing processes (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). According to one embodiment, the electrode base housing 150 is configured to be connected to a "loop" (eg, Velcro®) fastening layer 256 located in a groove in the inner peripheral edge of the elastic housing 150. It's okay. According to one embodiment, in order to connect the electrode pad 56a to the electrode base housing 150 in a reversible manner, the user arranges the electrode pad 56a in the housing 150 so that the hook layer 252 and the loop layer of the electrode pad 56a can be released. The 256 can be reversibly attached, thereby ensuring contact between the conductive layer 154 and the liquid absorbing layer 254.

Here, referring to FIGS. 17A and 17B, the electrode pad 56a has three layers (ie, a liquid absorbing layer 254, preferably a flexible conductive layer 258 composed of a flexible carbon layer, and a flexible conductive layer 258. A "hook" (eg, Velcro® fastening layer 252) connected to at least a portion of the lower edge of the electrode pad 56a may be provided. These three layers can be attached by various manufacturing processes (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). According to one embodiment, the electrode base housing 150 is configured to be connected to a "loop" (eg, Velcro®) fastening layer 256 located in a groove within the inner peripheral edge of the housing 150. good. According to one embodiment, in order to connect the electrode pad 56a to the electrode base housing 150 in a reversible manner, the user arranges the electrode pad 56a in the housing 150 so that the hook layer 252 and the loop layer of the electrode pad 56a can be released. The 256 can be reversibly connected, thereby ensuring contact between the conductive layer 154 of the electrode base housing 150 and the conductive layer 258 of the electrode pad 56a.

The conductive layer 258 may preferably be configured to include a layer of conductive paint that may be printed on a lower surface configured to face the conductive layer 154 of the electrode base housing 150. Since this conductive coating layer can improve the current distribution on the conductive layer 258 and the liquid absorption layer 254, the current distribution on the skin surface in contact with the skin can be improved.

The electrode pad 56a may be configured to include a conductive "male" connector (eg, a "male" snap connector). This "male" connector may be physically and electrically connected to the electrode pad 56a and is reversible to the corresponding "female" snap connector in the electrode base housing 150 that can be electrically connected to the headset electrical circuit. May be physically and mechanically connected to.

Here, referring to FIGS. 18A and 18B, the electrode pad 56a is composed of three layers (ie, a liquid absorbing layer 254, preferably a flexible conductive layer 258 composed of a flexible carbon layer, and a flexible conductive layer 258. An adhesive hydrogel layer 302) may be provided. The liquid absorbent layer 254 and the flexible conductive layer 258 can be attached by various manufacturing processes (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). The adhesive hydrogel layer 302 can be attached to the flexible conductive layer 258 due to the adhesive properties of the hydrogel layer. According to one embodiment, in order to releasably connect the electrode pad 56a to the electrode base housing 150, the user arranges the electrode pad 56a in the housing 150 to provide the adhesive hydrogel layer 302 and conductivity of the electrode pad 56a. The sex layer 154 can be reversibly connected, and the physical and electrical connections of the electrode base housing 150 and the electrode pad 56a can be stably secured.

Here, referring to FIGS. 19A and 19B, the electrode pad 56a includes a liquid absorbing layer 254, a flexible conductive layer 258 (consisting of, for example, a flexible carbon layer), and the conductivity of the housing 150. It may be configured to include a double-sided adhesive layer 308 connected to at least a portion of the lower peripheral edge of the electrode pad 56a configured to face layer 154. The liquid absorbent layer 254 and the flexible conductive layer 258 can be attached by various manufacturing processes (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). The double-sided adhesive layer 308 can be attached to the flexible conductive layer 258 due to its adhesive properties. According to one embodiment, in order to releasably attach the electrode pad 56a to the electrode base housing 150, the user arranges the electrode pad 56a in the housing 150 so that the double-sided adhesive layer 308 and the housing 150 of the electrode pad 56a can be released. Can be reversibly connected, whereby the physical and electrical connections of the electrode base housing 150 and the electrode pad 56a can be stably secured.

Here, referring to FIGS. 20A and 20B, the electrode pad 56a is configured to include a liquid absorbing layer 254 and a flexible conductive layer 258 preferably made of flexible carbon. good. The liquid absorbent layer 254 and the flexible conductive layer 258 can be attached by various manufacturing processes (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). The electrode pad 56a may include an edge portion 312 that is thinner than the central region of the liquid absorption layer 254. The thinner edge 312 can be made by a specific manufacturing process (eg, ultrasonic welding, RF welding or thermal compression). The user reverses the electrode pad 56a to the electrode base housing 150 by pressing the electrode pad 65a into the housing 150 until the thinner edge 312 is "snapped" into the corresponding groove 310 in the housing 150. Can be connected. At this position, the conductive layer 258 of the electrode pad 56a and the conductive layer 154 of the electrode base housing 150 are attached, so that when the headset is attached, the current is transferred from the conductive layer 154 to the conductive layer 258 and the liquid absorbing layer. It can be moved to 254 and then to the skin surface.

FIG. 21 is a perspective view of the electrode base 60. According to the particular features of the preferred embodiments described, the electrode base 60 may be configured to be physically connected to the flexible member 80 on one side and to the electrode base housing 150 on the other side. It may be configured to include at least one spring mechanism 320. The spring mechanism 320 may be configured to provide "self-adjusting" capability for the electrode base housing 150 so that when the headset is attached, the force exerted by the headset on the electrode base housing 150 and from the head is applied. The spring mechanism 320 compresses or expands according to the drag force applied. In certain embodiments, the spring mechanism 320 may include an elastic mechanism or sponge in place of or in addition to the metal or plastic spring.

21A and 21B are perspective views and cross-sectional views of the electrode pad 56a and the bellows type electrode base housing 150 according to the embodiment of the present invention, respectively. The electrode base housing 150 may be configured to include a flexible bellows carrier 321 that may be physically connected to the bottom of the electrode base housing 150 or configured to extend from the bottom of the electrode base housing 150. .. The flexible bellows carrier 321 may be configured to provide "self-adjusting" capability for the electrode base housing 150, so that when the headset is attached, the force exerted by the headset on the electrode base housing 150 and The bellows carrier 321 compresses or expands according to the drag applied from the head.

Referring to FIG. 21B, the flexible bellows carrier 321 may be configured to have the following dimensions:
The height A of each folded portion of the A-bellows may be in the range of 1 mm to 8 mm, 2 mm to 6 mm or 2 mm to 4 mm.
The angle B of each folded portion of the B-bellows may be in the range of 40 ° to 90 °, 50 ° to 80 ° or 60 ° to 80 °.
The wall thickness C of the C-bellows may be in the range of 0.3 mm to 3 mm, 0.4 mm to 2 mm or 0.5 mm to 1.5 mm.

21C and 21D are perspective views and cross-sectional views of an electrode pad 56a and an electrode base housing 150 having a conical bellows carrier 321 according to an embodiment of the present invention, respectively. The conical flexible bellows carrier 321 may be configured to be physically connected to the bottom of the electrode base housing 150 or to extend from the bottom of the electrode base housing 150. The bellows carrier 321 can be configured to provide "self-adjusting" capability for the electrode base housing 150, so that when the headset is worn, the force exerted by the headset on the electrode base housing 150 and from the head. The bellows carrier 321 may be compressed or expanded according to the applied drag. The bellows carrier 321 may be configured to reversibly repeatedly crush to less than 50%, less than 40%, less than 30% or less than 20% of the initial relaxed height. As a result, it is possible to significantly improve the alignment of the headset and the electrode pads 56a with respect to the head.

FIG. 22 is a perspective view of the electrode base housing 150. According to one embodiment, the electrode base housing 150 may be configured to include an outer peripheral sealing rim 360. When hair is stimulated, such as when trying to non-invasively stimulate various areas of the head, problems arise because the hair causes a high impedance layer between the surface electrodes and the skin. Solid adhesive hydrogels are the most common conductive medium used in electrical stimulation electrodes. However, in the case of hydrogels, the use of hydrogels is not very suitable because in the presence of hair the hydrogels do not easily penetrate the hair layer. Other conductive media (eg, semi-liquid conductive gels) may not be convenient to the user as they require cleaning / cleaning of the hair and device after each use session.

In contrast, tap water is more suitable in terms of penetration because it can pass through the hair layer and is free of residues. Moreover, in contrast to conductive gels, tap water is widely available. We need to maintain a substantial aqueous layer against the scalp during treatment, especially during long treatment sessions, to ensure the required conductivity and substantially uniform current distribution, and dehydration. I found it necessary to avoid. Avoidance of electrode dehydration may be necessary in hairless areas (eg, forehead). As such, the electrode pads and the configuration of the present invention typically do not contain or substantially do not contain hydrogel.

FIG. 23 is a cross-sectional view of the electrode base housing 150 into which the electrode pad 56a is inserted.

FIG. 24 is a cross-sectional view of the electrode base housing 150 into which the electrode pad 56a is inserted while being urged to the skin surface 362. The housing 150 is urged to the skin surface when pressure is applied perpendicular to the sealing rim 360 with respect to the electrode base 60 (not shown) and to the user's skin surface 362. The sealing rim 360 and the cavity created between the user's skin surface 362 and the atmosphere or external environment are adapted to be substantially sealed.

The sealing rim 360 can be constructed of a flexible material (eg, TPU or silicone) and has a modulus sufficient to maintain a constant level of pressure on the scalp to provide the required sealing effect. May be configured to have. However, if the modulus of elasticity is excessively high, excessive pressure can be applied to the scalp. The sealing rim 360 may be flexible enough to be self-aligned to various head shapes. The sealing rim 360 may be configured to have a high drag coefficient to assist in the stable placement of the electrodes in place with respect to the scalp. In addition, the sealing rim 360 may be configured to avoid dehydration of the water contained in the wet pad and the sealed space, allowing the stimulation session to be performed effectively and for a long period of time. Become. If the stimulating electrode is located in an area that does not require sealing, the sealing rim 360 may be configured to be removable from the electrode base.

Headsets may be configured to include sealing rims with different contours to ensure proper sealing function at specific skin surfaces and locations. To reach the required sealing effect, the sealing rim 360 may be configured to include a material that expands in the presence of water.

The electrode base housing 150 with the sealing rim 360 is configured to be usable in hairless areas (eg, forehead or other areas of the body) to avoid dehydration of the electrode pads. Can be done.

The electrode base housing 150 with the sealing rim 360 may be configured to include the following dimensions (see FIG. 25).

The inner surface of the flexible outer wall of the housing 150 has a radial curvature. The radial distance (A) between the inner surface of the rim 360 and the most radial inner point of the inner surface of the wall of the housing 150 is in the range of 1-15 mm, 2 mm-10 mm or 2 mm-7 mm.

The outer surface of the flexible outer wall of the housing 150 has a radial curvature, and the length of curvature (B) is in the range of 1 mm to 15 mm, 2 mm to 10 mm or 2 mm to 8 mm.

FIG. 25A is a cross-sectional view of the electrode base housing 150 of the present invention. The electrode base housing 150 has a sealing rim 360 and includes an electrode pad 56a. The electrode pad is urged to the skin surface 362. The housing 150 is urged and sealed to the skin surface when pressure is applied to the user's skin surface 362 perpendicular to the sealing rim 360 with respect to the electrode base 60 (not shown). The cavities created between the rim 360 and the user's skin surface 362 and the atmosphere or external environment may be adapted to be substantially sealed.

The sealing rim 360 may be made of a flexible material (eg, TPU or silicone) and has a modulus of elasticity sufficient to maintain a constant level of pressure on the scalp that provides the required sealing effect. It may be configured as follows. However, if the modulus of elasticity is excessively high, excessive pressure can be applied to the scalp.

According to a particular embodiment, the hardness level of the sealing rim 360 is 20-50 shore A, more preferably 20-40 shore A, most preferably 30-40 shore A.

According to a particular embodiment, the elastic modulus (E) of the sealing rim 360 (at 100% strain) is 0.4 MPa to 3 MPa, 0.5 MPa to 2 MPa, or 0.5 MPa to 1.2 MPa. be.

The sealing rim 360 may be configured to avoid dehydration of the water contained in the wet pad and the sealed space, allowing the stimulation session to be performed effectively and for a long period of time.

FIG. 25B is a cross-sectional view of the arrangement configuration of the housing 150, the sealing rim 360 and the pad 56a of 25A in relaxation mode, defining the wall geometry. The electrode base housing 150 including the sealing rim 360 may be configured to have the following dimensions (see FIG. 25B).

The sealing rim wall thickness (A) may be 0.3 mm to 3.0 mm, 0.4 mm to 1.5 mm, or 0.5 mm to 1 mm.
The sealing rim curvature length (B) may be 1 mm to 10 mm, 2 mm to 8 mm or 3 mm to 6 mm.
The height of curvature of the sealing rim (C) may be 1 mm to 10 mm, 2 mm to 8 mm, or 2 mm to 4 mm.

FIG. 25C is a perspective view of the electrode base housing 150 of the present invention including the electrode pad 56a. The housing includes a plurality of closely arranged sealing fingers 361 that surround the electrode pad 56a in the circumferential direction. When pressure is applied to the skin surface of the user perpendicular to the sealing finger 361 with respect to the electrode base 60 (not shown), the housing 150 is urged to the skin surface to seal the housing 150. The cavities created between the finger 361 and the user's skin surface and the atmosphere or external environment may be adapted to at least partially or at least substantially seal.

The sealing finger 361 may be made of a flexible material (eg, TPU or silicone) and has a modulus of elasticity sufficient to maintain a constant level of pressure on the scalp that provides the required sealing effect. It may be configured to have.

According to certain embodiments, the sealing "finger" 361 is configured to be self-aligned to various surface / skin contours. The surface tension of the fluid prevents the fluid from flowing between the fingers 361, whereby the fluid is held around the pad 56a.

25D is a cross-sectional view of the arrangement configuration of FIG. 25C.

25E is a top view of the arrangement configuration of FIG. 25C. The electrode base housing 150 including the sealing finger 361 may be configured to include the following dimensions (see FIGS. 25D, 25E).

The thickness (A) of the sealing finger 361 is preferably 0.3 mm to 1.5 mm, more preferably 0.4 mm to 1.2 mm, and most preferably 0.5 mm to 1 mm.

The angle (B) of the sealing finger 361 is preferably 20 ° to 90 °, more preferably 40 ° to 80 °, and most preferably 60 ° to 80 °.

The width (C) of the sealing finger 361 is preferably 0.3 mm to 3 mm, more preferably 0.4 mm to 2.5 mm, and most preferably 0.5 mm to 1.5 mm.

The gap (D) between the sealing fingers 361 is preferably 0.1 mm to 1.5 mm, more preferably 0.2 mm to 0.1 mm, and most preferably 0.2 mm to 0.8 mm.

FIG. 25F is a cross-sectional view of the arrangement configuration of the housing 150 and the pad 56a of the present invention, in which the wall curvature 363 of the housing 150 captures and captures excess fluid in the cavity 366 generated between the inner wall curvature and the pad 56a. Adapted to save. When the headset is worn, the pad 56a can be urged to the head to release some of its excess fluid into the cavity 366. The fluid contained in the cavity 366 may then be reabsorbed by the pad 56a and released to the skin surface.

FIG. 25G is a schematic perspective sectional view showing a state in which the electrode base housing 150 according to the embodiment of the present invention is arranged on the user's head 5 and urged to the head. FIG. 25H is an enlarged view of the electrode base housing 150 and the sealing rim 360 being urged to the head 5.

FIG. 26 is a perspective view of a flexible comb-shaped (“hair combing”) member 376 located above the electrode base housing according to an embodiment of the present invention. The member 376 may be configured to be physically connected to the headset above the electrode base housing 150 and may also include some elongated rigid and preferably semi-rigid members or or teeth 378. It may be configured as follows.

FIG. 27 is a perspective rear view of the wearing headset in which the flexible comb-shaped member 376 projects above the outer peripheral band of the headset 10. While the user wears the headset 10 on his head 372, the elongated member 378 is configured to project above the electrodes in the area containing the hair (eg, the back or side of the head). May be done. The comb-shaped member 376 is configured so that the headset 10 can be easily attached while temporarily and surely pushing away the hair layer under the electrode so that the hair remaining between the electrode and the skin is minimized. You can do it. The flexible comb-shaped member 376 may be configured to function like a comb, with the hair being placed in an operating position on the head 372 by the user pushing the headset 10 upwards with the electrodes. A layer of 374 is separated from the scalp, which ensures the required conductivity between the electrodes and the skin.

According to another feature of the preferred embodiment described, the member 376 may be configured to be removable from the headset 10 so that the user can remove it by himself if the user's hair is short. ..

The headset of the present invention is configured to stimulate different areas of the head with electrodes of different shapes and sizes. The headset may include electrodes configured to stimulate the forehead area.

FIG. 28 is a perspective front view of the mounted headset 10. The headset is configured to stimulate specific nerve branches within the forehead region and the anterior electrodes 110a, 110b are fitted. These particular nerve branches include the supratrochlear nerves 120a, 120b and the supraorbital nerves 122a, 122b, both of which are surface branches of the trigeminal nerve. Electrodes 122a, 122b may be configured to have a narrow, elongated profile to achieve the desired neural depolarization with minimal irritation intensity and a sufficient level of perceptual comfort, as well as eyebrows 112a and 112b. It may be configured to be at least partially aligned with the outer shape. The electrodes 110a, 110b may be configured to have the smallest size and specific shape to minimize the discomfort that occurs when the nociceptive nerve fibers located on the periosteum of the skull are activated. The electrodes 110a, 110b may also be configured to adequately ensure stimulation of the target nerve regardless of a wide range of morphological variables in the target population. As a further consideration that can affect the dimensions of the electrodes and in particular their length, it is predicted that they may occur in the rotational arrangement of the headset 10 when worn by the user. Therefore, these electrodes may preferably be configured to have sufficient length to ensure the placement of at least a portion of the electrodes above the target nerve during such rotational deviations.

FIG. 29 shows an embodiment of the electrode 110a that can be configured for stimulation of the supraorbital region. The electrode 110a may contain a biocompatible conductive material. The biocompatible conductive material may be configured to face the skin surface and may include an electrode support attached to the conductive contact surface. The support may comprise at least one conductive material or element that may be electrically connected to the conductive contact surface.

The electrode 110a may be configured to have a conductive contact surface having the following dimensions.
(I) A long portion ( _DL ) having a length of 20 mm to 55 mm, 25 to 50 mm or 30 to 45 mm.
(Ii) A short portion ( _DN ) having a length of 10 mm to 30 mm, 10 to 25 or 12 to 20 mm.
The concave outer shape E has a concave surface defined by boundary points G and F arranged at opposite ends of the concave surface.

であり、
Ｈ_ｍａｘは、この全体におけるＨの最大値であり、
Ｈ_ｍｉｎは、この全体におけるＨの最小値である。 Typically, the A / L is at least 0.5 mm.
A is a region defined by a dotted line K and a concave surface.
L is the length of the line K (between the boundary points G and F), (L) is at least 10 mm, and the line is on the concave outer shape on the peripheral edge of the electrode 110a on the opposite side of the concave outer shape E. Arranged between the first and second points of the above, aligned perpendicular to the outer shape E at the first point, this line has a length H.
In the entire concave outer shape,

And
H _max is the maximum value of H in this whole.
H _min is the minimum value of H in this whole.

The distance between the two electrodes configured to stimulate the supraorbital region may be in the range of 5 to 45 mm, 8 to 35 mm or 8 to 25 mm. Additional electrodes may be placed on the headset to stimulate other nerves (eg, zygomaticotemporal or auricular temporal nerve). The headset may also include electrodes configured to stimulate the occipital region.

In FIG. 30, electrodes 146a, 146b are placed posteriorly (opposing the occipital region) of the headset 10 to stimulate nerves in the occipital region 140 (eg, left large occipital nerve 142a and right large occipital nerve 142b). An embodiment configured as such is shown. Additional electrodes may be placed in the headset and may be configured to stimulate other nerves in the head region (eg, left and right small occipital nerves 143a, 143b).

To stimulate the branches 142a, 142b of the large occipital nerve, these electrodes may be configured to be located above the nerve branch at approximately the height of the occipital ridge, where the branch of the large occipital nerve is: It becomes the surface after penetrating the trapezius fascia. Stimulation of the lower part of this anatomical area can cause the upper cervical muscle to contract unfavorably, while stimulation of a higher area can cause the scapular muscle to contract unfavorably and also the nociceptive nerve fibers of the skull membrane. Pain can occur due to its proximity to. Therefore, use electrodes of appropriate dimensions that ensure effective stimulation with a high level of perceptual comfort in the correct placement of the electrodes, and ensure that the stimulation does not overflow to nearby muscles. It is important to grant. In some embodiments, the dimensions of the electrodes 146a, 146b are preferably 20 to 50 mm in length and 8 to 40 mm in height, and the electrodes 146a, 146b are 5 to 5 to a distance from the occipital median. It may be placed at a location of 35 mm. More typically, the electrodes 146a, 146b may have a length in the range of 25-45 mm and a height in the range of 10-25 mm, with the electrodes 146a, 146b from the occipital median. It may be placed at a distance of 8 to 25 mm.

FIG. 31 is a side perspective view of a symmetrical member 50a that is part of the headset of the present invention according to one embodiment. According to the particular features of the preferred embodiments described, the member 50a is configured to be rigid (preferably semi-rigid) and has a curved portion 408 adapted to align behind and above the ear. Have.

FIG. 32 is a perspective view of the headset 10 on the head 500. The headset 10 may be configured to be repetitively and intuitively accurately placed on the head by a user without medical expertise. Accurate placement of electrodes on target peripheral nerves and brain regions is essential to achieving the desired therapeutic benefit. When stimulating the head area, any deviation of the electrode position can cause discomfort and even pain due to irritation on the periosteum of the skull or muscles (eg, frontal region, temporal muscles, shoulders). Accurate electrode placement is especially important as it can cause unwanted motor contractions of the instep or upper cervical muscle).

The symmetrical rigid and preferably semi-rigid member 50a allows the user to place the headset 10 on its head 500 in a manner that is substantially accurate and repeatable. May be configured. When the curved bilaterally symmetric member 50a is placed behind and above both ears, the (rotational) and longitudinal placement of both outer peripheries of the headset 10 is determined with respect to the head 500.

The headset 10 may be configured to include a recess 410 at its anterior portion configured to align above the nasal bridge 506 with the glabellar median. To ensure proper perimeter (rotation) and longitudinal placement of the headset 10 with respect to the head 500 without the need for mirrors, the user puts his thumb on the nasal bridge 506 and his (same hand). One of the fingers can be placed on the recess 410 to ensure accurate placement of the headset 10.

The outer shape of the anterior elastic member 40 of the headset 10 may be configured to align with the anatomical line of the eyebrows 502 and the upper region of the nasal bridge 506, whereby the user can press the anterior elastic member 40 of the headset 10 Aligning with the top of the eyebrows determines the direction of rotation and longitudinal placement of the headset.

The rotational position of the symmetrical semi-rigid member 50a relative to the headset 10 can be individually adjusted to suit each particular user. Semi-rigid members 50a of different sizes and shapes can be selected to optimally adjust the placement direction of the headset 10. Various outer dimensions of the anterior elastic member 40 can be selected to adjust the anterior longitudinal orientation of the headset. The position of the recess 410 can be adjusted or the headset 10 and its integrated electrodes can be configured for asymmetric alignment as needed.

The posterior elastic member 30 of the headset 10 may be configured to have a concave shape that may be aligned above the occipital protrusions and the nomenclature line, whereby the longitudinal arrangement of the headset 10 (more specifically). The longitudinal arrangement of the occipital elastic member) may be determined.

FIG. 33 is a perspective front view of the headset 10 including the "nasal bridge" member 510. The "nasal bridge" member 510 may be configured to be located within the central region of the elastic member 40. The "bridge of nose" member 510 may be rigid or semi-rigid and may have two elongated portions adapted to be aligned on the upper part of the nose and on both sides of the bridge of the nose. By positioning the "bridge of nose" member on the nose, the user can determine the rotational and longitudinal placement of the headset 10.

The "nasal bridge" member 510 may be further configured to support the member 40 against gravity. The "nasal bridge" member 510 may be configured to be removable from the headset 10. Various sizes and shapes of "nasal bridge" members 510 can be selected for the individual user. The "nose bridge" member 510 may be configured to be manually adjusted by the user so that it can be optimally adjusted to the user's nose.

FIG. 34 is a perspective view of the headset 10 having the spectacles 520. The spectacles 520 may be adapted to be connected to the anterior elastic member 40. In some embodiments, the spectacles 520 are
Reversible and reversible removable from headset 10
Includes various lenses (eg, optical lenses, sunglasses, or non-optical transparent lenses to improve vision)
Includes dark lenses that can be used, for example, to block external light for assistance or relaxation in the event of a migraine.
It may be configured as follows.

FIG. 35 is a perspective view of a headset 10 having earphones (eg, symmetrical earphones 522). In some embodiments, the symmetrical earphones 522 may be configured to be electrically connected to at least a semi-rigid symmetrical member 50a.

In some embodiments, the earphone 522 and the symmetrical member 50a may be configured such that the earphone 522 can be reversibly and repeatedly removed from the symmetrical member 50a.

In some embodiments, the symmetrical member 50 may be adapted to include an interior space and an opening that can be used to store the earphone 522 when the earphone 522 is not in use. The symmetrical member 50 may include a mechanism for pulling the earphone 522 into the storage space in the symmetrical member 50a when the earphone 522 is not used.

FIG. 36 is a perspective view showing the headset 10 with a remote control or remote control handset 560, a mobile phone 570 and a laptop / PC 580.

In some embodiments, the headset 10 may be configured to communicate wirelessly with the remote control 560. The remote control 560 can be used by the user to send a command (eg, a stimulus start or stop command) or a command to increase or decrease the stimulus intensity to the headset 10. Various visual and vocal instructions regarding the condition of the headset 10 can also be presented to the user.

The headset 10 may be configured to communicate wirelessly with the mobile phone 570. The mobile phone interface can be used to present various data transmitted wirelessly from the headset 10 (eg, visual and audible instructions about the state and usage log of the headset 10).

The headset 10 may be configured to communicate wirelessly with the laptop / PC 580. The mobile phone interface can be used to present various data transmitted wirelessly from the headset 10 (eg, visual and audible instructions about the state and usage log of the headset 10).

Communication between the headset 10 and the remote control 560, the mobile phone 570 and the laptop 580 can be performed by various methods known to those of skill in the art (eg, Bluetooth® communication).
As used herein and in the appended claims, the term "monolithic" means to structurally function as a single, at least semi-rigid unit.

As used herein and in the appended claims, "monolithically mountable" to a headset, headset frame, etc. means a single at least a single headset, headset frame, etc. It refers to a structure that can be mounted as a semi-rigid whole.

As used herein and in the appended claims, terms such as "mode of operation" for a headset or headset component are appropriate rotational and longitudinal directions in the presence of electrical stimulation. Refers to a headset or headset component that fits the user's head in the placement of.

As used herein and in the appended claims, terms such as "wearing mode" and "wearing" for a headset or headset component are appropriate in the presence of electrical stimulation. Refers to a headset or headset component that is fitted to the user's head in a rotational and longitudinal arrangement.

As used herein and in the appended claims, the term "integral" refers to a structure that functions as a single whole structure. The term may be particularly applied to flexible structures (eg, electrode pads).

It is understood that the particular features of the invention described in the context of separate embodiments for clarity may be combined with a single embodiment. Conversely, for brevity, the various features of the invention described in the context of a single embodiment may be used separately or in any further combination. Similarly, the content of a claim that is dependent on one or more particular claims may generally be dependent on other unspecified claims, or does not include any particular obvious nonconformity between the two. It may be combined with the content.

Although the present invention has been described with particular embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications and modifications will be conceived. Accordingly, the present invention is intended to include all of the intended claims and alternatives, modifications and modifications that are included within the broad scope.

Claims (15)

A headset used in the delivery of electrical stimuli to the skin surface of the user's head, said headset.
(A ) An outer peripheral headset body having a structural function as a frame , wherein the outer peripheral headset main body includes at least one elastic member (30, 40).
The outer peripheral headset body is fitted along the outer circumference of the user's head, and the outer peripheral headset body houses an electrical circuit adapted to be connected to a power source.
An outer peripheral head in which the at least one elastic member is placed on at least a portion of the outer circumference of the outer peripheral headset body and the at least one elastic member is adapted to extend along the outer circumference. With the set body,
(B) At least one electrode base mechanically connected to the outer peripheral headset body and electrically associated with the electrical circuit so that the electrode base receives at least one electrode pad. Fitted with electrode base,
Equipped with
The outer peripheral headset body and the electrode base are adapted to direct the electrical stimulation surface of the electrode pad towards the skin surface when worn by the user.
In the at least one elastic member, the at least one elastic member radially urges the electrode base to the skin surface when the user wears the electrode pad physically and physically with the skin surface. Fitted for electrical contact,
The at least one elastic member and the electrode base are so as to fix the relative position of the electrode base in the circumferential direction with respect to the outer peripheral headset main body even if the at least one elastic member is variably stretched. Fitted,
headset. The outer peripheral headset body has an anterior portion adapted along the perimeter of the anterior portion of the head, and at least one of the at least one electrode base is an anterior electrode disposed on the anterior portion. The headset according to claim 1, which is a base. The headset according to claim 2, wherein the front portion covers up to 40% of the outer circumference of the outer peripheral headset main body. The outer peripheral headset body has a rear portion adapted along the periphery of the rear portion of the head, and at least one of the at least one electrode base is a rear electrode base disposed on the rear portion. The headset according to any one of claims 1 to 3. The headset according to any one of claims 1 to 4 , wherein the outer peripheral headset main body includes at least a first symmetrical size adjusting mechanism. The outer peripheral headset body comprises a side component and is adapted to adjust the outer circumference of the outer peripheral headset body with a first symmetrical size adjusting mechanism and a second symmetrical size adjusting mechanism. The first symmetrical size adjusting mechanism connects the side component to the front portion of the outer peripheral headset main body, and the second symmetrical size adjusting mechanism has the side configuration. The element is connected to the rear part of the outer peripheral headset body,
The anterior portion is adapted to engage around the anterior portion of the user's head, and the posterior portion is adapted to engage around the posterior portion of the head.
The first symmetrical size adjusting mechanism and the second symmetrical size adjusting mechanism can adjust the outer circumference of the outer peripheral headset body while the outer peripheral position of the side component is fixed. The headset according to claim 5 . The outer peripheral headset body is adapted so that the contact surface of the electrical device is juxtaposed on the skin surface, and at least one elastic member urges the electrical device to the skin surface in the radial direction. The contact surface of the electric device is adapted to be in physical contact with the skin surface, and the at least one elastic member can variably extend the at least one elastic member to obtain the outer peripheral position of the electrical device. The headset according to any one of claims 1 to 6 , which is adapted to be fixed in a unique position with respect to the frame . The headset of claim 7 , wherein the electrical device comprises a sensor adapted to sense a parameter associated with the user's head. The at least one electrode pad is
(A) A water absorbing layer having a biocompatible conductive contact surface, wherein the contact surface is a water absorbing layer adapted to be juxtaposed on the skin surface.
(B) A conductive layer having a wide first surface attached to the water absorption layer, wherein the conductive layer comprises at least one conductive material or element, and the conductive layer is the said. A conductive layer, adapted to transfer an electric current from a wide second surface distal to the first surface to the water absorption layer through the first surface.
The headset according to any one of claims 1 to 8 . The headset of claim 9 , wherein the water absorbing layer comprises at least one material selected from the group consisting of non-woven fabrics, felts or sponges. The headset according to claim 9 or 10 , wherein the conductive layer has a conductive paint layer arranged in a mesh pattern on the second surface. The headset according to any one of claims 9 to 11 , wherein the conductive layer contains a carbon foil. 12. The headset according to claim 12 , wherein the carbon foil has a resistance of 1 to 180 Ω / square or 30 to 100 Ω / square. The headset according to claim 11 , wherein the water absorbing layer and the conductive layer have the conductive coating layer forming an integral structure. The electrode base is
(A) A housing including a floor and a flexible outer peripheral member surrounding the floor, wherein the outer peripheral member forms an outer peripheral wall extending above the peripheral edge of the floor, and the outer peripheral wall is formed by the outer peripheral wall. With the housing, terminated at the outer rim, the floor and the flexible outer member form a cavity adapted to receive the conductive electrode pad.
(B) A conductive material located at least above or inside the floor, adapted to be electrically associated with an electrical circuit by a conductor, and when the pad is inserted, electrically with the electrode pad. Conductive material, which is adapted to communicate with
Equipped with
The rim and the flexible outer wall urge the rim to urge the skin surface when pressure is applied to the electrode base towards the user's skin surface approximately perpendicular to the rim. The cavity is adapted to be substantially fluid-sealed between the cavity and the ambient or external environment.
The headset according to any one of claims 1 to 14 .

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