JP2016515404A - Headset for treatment and evaluation of medical conditions - Google Patents

Abstract

A peripheral headset used in delivering electrical stimulation to the skin surface of the head. [Selection] Figure 2

Description

  The present invention relates to an apparatus and method for applying electrical stimulation to the head region, a headset having electrodes for performing treatment of a medical condition using non-invasive electrical stimulation, and to evaluate the medical condition The invention relates to adapted headsets, as well as electrode arrangements for use with such headsets.

  In accordance with some teachings of the present invention, a headset is provided that is used to deliver electrical stimulation to the skin surface of the user's head. The headset is (a) a peripheral headset body, the body having a monolithic frame adapted to follow the outer periphery of the user's head, and the body is adapted to be connected to a power source. The headset body has an elastic arrangement disposed on at least a portion of the outer periphery of the headset body, the elastic arrangement being adapted to extend along the outer circumference A 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, wherein the electrode base is at least An electrode base adapted to receive one electrode pad, wherein the headset body and the base are electrically stimulated surfaces of the pad when worn by a user Adapted to orient towards the skin surface, the elastic arrangement causes the electrode pad to make physical and electrical contact with the skin surface as the elastic arrangement biases the electrode base radially against the skin surface when worn The elastic arrangement and the electrode base are adapted such that the outer peripheral position of the electrode base relative to the frame is fixed in a unique position due to the variable extension of the elastic arrangement.

  According to another aspect of the invention, an electrode pad is provided. The electrode pad comprises: (a) a water-absorbing layer having a biocompatible conductive contact surface, the contact surface being adapted to be juxtaposed to the skin surface; and (b) a wide area attached to the water-absorbing layer. A conductive layer having a first surface, the conductive layer comprising a carbon foil or a carbon film, wherein the conductive layer conducts current from an extensive second surface distal to the first surface. A first surface forming a monolithic structure, a water absorbing layer and a conductive layer adapted to move through the conductive layer to the water absorbing layer.

  According to yet another aspect of the invention, an electrode base is provided. The electrode base is a housing including (a) a floor and a flexible outer peripheral member surrounding the floor, and has a flexible outer peripheral wall extending generally above the periphery of the floor, A housing terminating in the rim, the floor and the flexible outer member forming a cavity adapted to receive a conductive electrode pad; and (b) conductive disposed at least above or within the floor A material, wherein the conductive layer is adapted to be electrically associated with the electrical circuit by the conductor, and adapted to electrically communicate with the electrode pad in an operating mode when the pad is inserted; And a flexible outer wall that, when pressure applied to the electrode base is applied substantially perpendicular to the rim toward the user's skin surface, the rim is urged toward the skin surface to create a cavity and atmosphere or Outside Between the border has a conductive material which is adapted to be sealed substantially fluid sealed.

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。 In accordance with yet another aspect of the present invention, a biocompatible electrode is provided that is juxtaposed to a user's skin surface. The electrode is (a) a water-absorbing layer having a biocompatible contact surface, the contact surface being adapted to be juxtaposed to the skin surface, and (b) attached to the water-absorbing layer An electrode support, wherein the support comprises at least one conductive material or element, the conductive material or element being electrically connected to the water absorption layer in an operating mode when the water absorption layer is filled with water. And an electrode support portion connected to each other. The biocompatible contact surface has (i) a long part (D _L ) having a maximum length of 20 mm to 55 mm and (ii) a short part (D _N ) having a maximum length of 10 mm to 25 mm. And the first side of the periphery of the biocompatible contact surface has a generally concave profile having a concave surface defined by a first boundary point and a second boundary point located at opposite ends of the concave surface. Have

It is.
A is the area bounded by the line and the concave surface, 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 contour And a second point on the periphery on the opposite side of the concave contour, the line is aligned perpendicular to the contour at the first point, has a length H, and is 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.

  In accordance with yet another aspect of the present invention, a method is provided for mounting and placing a headset on a user's head substantially as described herein.

  According to still further features in the described preferred embodiments the outer peripheral headset body has a front portion adapted to lie around the front portion of the head and at least one electrode base is disposed on the front portion. A forward electrode base.

  According to still further features in the described preferred embodiments the forward portion is a forward mechanical element that is physically different from the outer headset body.

  According to still further features in the described preferred embodiments, the forward mechanical elements span up to 40%, up to 35%, up to 30% or up to 20% of the outer periphery of the outer peripheral headset body.

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

  According to still further features in the described preferred embodiments the outer peripheral headset body has a rear portion adapted to follow the circumference of the rear portion of the head, and at least one electrode base is disposed on the rear portion. And an electrode base is provided.

  According to still further features in the described preferred embodiments, the rear portion is a rear mechanical element that is physically different from the outer headset body.

  According to still further features in the described preferred embodiments the posterior machine element extends up to 40%, up to 35%, up to 30% or up to 20% of the outer periphery of the outer peripheral headset body. According to still further features in the described preferred embodiments the posterior machine element is 10% to 40%, 15% to 40%, 20% to 40%, 25% to 40% or 25 of the outer periphery of the outer peripheral headset body. It ranges from% to 35%.

  According to further features in the described preferred embodiments, the front and rear machine elements generally range from 45% to 75%, 50% to 75%, 55% to 75% or 55% to 70% of the outer periphery. .

  According to still further features in the described preferred embodiments the frame comprises at least a semi-rigid side component arranged bilaterally on the frame and forms a peripheral side of the headset body.

  According to further features in the described preferred embodiments, the side components are generally 15% to 50%, 20% to 50%, 25% to 50%, 30% to 50%, 35% of the outer periphery. % -50% or 30% -45%.

  According to still further features in the described preferred embodiments the side components each have elements arranged substantially perpendicular to the outer periphery and adapted to follow the back of the user's ear in a wearing mode .

  According to still further features in the described preferred embodiments, the outer peripheral stiffness of the side component exceeds the outer peripheral stiffness of the front and rear portions.

  According to further features in the described preferred embodiments, the perimeter elasticity of the front and rear portions exceeds the perimeter elasticity of the side components.

  According to still further features in the described preferred embodiments the frame comprises a positioning system for angular and longitudinal positioning of the headset body, the positioning system comprising at least one at least semi-rigid side component. Prepare. The side component forms a portion of the outer periphery and is generally perpendicular to the elongate element, a first elongate element adapted to lie above the user's ear to determine longitudinal positioning. And a second element adapted to follow the back of the ear to determine the angular positioning of the headset body.

  According to still further features in the described preferred embodiments the frame comprises at least a first symmetrical size adjustment mechanism adapted to fixedly adjust the outer periphery of the headset body.

  According to still further features in the described preferred embodiments the adjustment mechanism is rigid or at least semi-rigid.

  According to still further features in the described preferred embodiments the frame comprises a first symmetrical size adjusting mechanism and a second symmetrical size adjusting mechanism adapted to adjust the outer periphery of the headset body. . The first adjustment mechanism connects the side component to the front portion, and the second adjustment mechanism connects the side component to the rear portion.

  According to still further features in the described preferred embodiments the first adjustment mechanism and the second adjustment mechanism are capable of adjusting the outer periphery of the headset body while the outer peripheral position of the side component remains fixed. Is adapted to.

  According to still further features in the described preferred embodiments the frame is substantially inelastic along at least 30%, at least 40%, at least 50% or at least 60% of the perimeter length. Is adapted to.

  According to still further features in the described preferred embodiments the headset body is adapted to cause the contact surface of the electrical device to be juxtaposed to the skin surface and the resilient arrangement configuration biases the electrical device radially to the skin surface. And the elastic arrangement is adapted to bring the contact surface of the electrical device into physical contact with the skin surface so that the outer peripheral position of the electric device is fixed in a unique position due to the variable extension of the elastic arrangement. Be adapted.

  According to still further features in the described preferred embodiments the electrical device comprises a sensor adapted to sense body parameters associated with the user's head.

  According to still further features in the described preferred embodiments the water absorbing layer of the electrode pad comprises at least one material selected from the group consisting of nonwoven fabric, felt or sponge.

According to still further features in the described preferred embodiments the conductive layer has a conductive layer on the second surface distal from the water absorbing layer that has a higher conductivity than the majority of the conductive layer. This highly conductive layer is typically a conductive paint and is preferably arranged in a mesh pattern.
According to still further features in the described preferred embodiments the water-absorbing layer and the conductive layer have a layer of conductive paint forming a monolithic structure.

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

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

  According to still further features in the described preferred embodiments a plurality of sealing fingers with a volume are disposed circumferentially on the electrode-based rim, the sealing fingers biasing the rim toward the skin surface And the plurality of sealing fingers are adapted to substantially seal between the volume and the volume external to the sealing fingers.

  According to still further features in the described preferred embodiments the rim comprises or consists essentially of a plurality of sealing fingers arranged in the outer circumferential direction and consists of a plurality of sealing fingers arranged in the outer circumferential direction. The fingers are generally perpendicular to the electrode base floor or the skin surface when pressure is applied, such that the plurality of sealing fingers substantially seal between the cavity and the volume outside the rim. Is adapted to.

  According to still further features in the described preferred embodiments the electrode arrangement ratio A / L 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. It is.

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

  According to still further features in the described preferred embodiments the electrode arrangement further comprises an electrode pad.

  According to still further features in the described preferred embodiments the inner surface of the flexible outer peripheral wall has a radial curvature and is radially between the inner surface of the rim and the radially innermost point 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 described preferred embodiments, the 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 still further features in the described preferred embodiments the outer surface of the flexible outer peripheral wall has a radial curvature, and the length of the outer surface curvature is at least 1 mm, at least 2 mm, at least 3 mm or at least 5 mm.

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

  According to still further features in the described preferred embodiments the electrode arrangement further comprises a pressure arrangement. The pressurization arrangement is mechanically associated with the electrode base and is adapted to deliver pressure to the electrode base substantially perpendicular to the rim.

  According to still further features in the described preferred embodiments the electrical device comprises a transmission arrangement adapted to transmit a signal from the sensor.

  According to still further features in the described preferred embodiments the electrode base housing comprises a flexible bellows-type member.

  According to still further features in the described preferred embodiments the electrode base housing comprises a liquid capture and storage arrangement.

  DETAILED DESCRIPTION OF THE INVENTION The present invention will be described herein with reference to the accompanying drawings, for illustrative purposes only. The details described herein with particular reference to the drawings are exemplary only, and are for purposes of illustration only and of exemplary embodiments of the invention. It is emphasized that it is presented in order to provide what is considered the most useful and understandable description of. In this regard, it is not intended that the structural details of the present invention be shown in more detail beyond the level necessary for a basic understanding of the present invention, but an embodiment that embodies several forms of the present invention. It is emphasized that the description shown with the drawings for the purpose of showing to a trader may actually be embodied. In the drawings, like reference numerals are used to denote like functions, but do not necessarily indicate the same element.

It is a perspective view of one embodiment of the headset of the present invention arranged on a user's head. It is a perspective view of one embodiment of the headset of the present invention arranged on a user's head. It is a perspective view of one embodiment of the headset of the present invention. It is a side view of the headset of the present invention arranged on the user's head. It is a side view of the headset of the present invention arranged on the user's head. It is a side view of a part of the headset of the present invention having a branched rear elastic member for improving the stability of the headset. It is a perspective view of the headset of the present invention which has a back elastic member which does not contain an electrode. 1 is a perspective view of an electrode base arrangement according to the present invention and an elastic member that accommodates the arrangement according to an embodiment of the present invention. FIG. 1 is a perspective view of an electrode base arrangement according to the present invention and an elastic member that accommodates the arrangement according to an embodiment of the present invention. FIG. FIG. 6 is a perspective view of an electrode base arrangement of the present invention, according to certain embodiments of the present invention. It is a perspective view which shows the elastic member shown to FIG. 7A with the cross section in the intermediate part. FIG. 7B is a cross-sectional view of the electrode base of FIG. 7 connected to the inside of the elastic member of FIG. 7A. It is a perspective view of the structure of this invention shown in FIG. Fig. 4 shows the adjustable electrode base arrangement of the present invention for adjusting the distance between adjacent electrode base housings and three different positioning of these electrode base housings. Fig. 4 shows the adjustable electrode base arrangement of the present invention for adjusting the distance between adjacent electrode base housings and three different positioning of these electrode base housings. Fig. 4 shows the adjustable electrode base arrangement of the present invention for adjusting the distance between adjacent electrode base housings and three different positioning of these electrode base housings. FIG. 12 is a perspective view of an elastic member that accommodates this adjustable electrode base arrangement shown in FIGS. Fig. 5 shows an adjustable electrode base housing arrangement and an elastic member housing this arrangement according to an embodiment of the present invention. Fig. 5 shows an adjustable electrode base housing arrangement and an elastic member housing this arrangement according to an embodiment of the present invention. It is sectional drawing of the electrode pad arrange | positioned on an electrode base. FIG. 16 is a perspective view of an electrode base (FIG. 15A) with and without a multilayer electrode pad according to the present invention (FIG. 15B). FIG. 16 is a perspective view of an electrode base (FIG. 15A) with and without a multilayer electrode pad according to the present invention (FIG. 15B). 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. 6 is a cross-sectional view of an electrode base assembly with a particular electrode pad structure connected to an electrode base housing therein, according to various embodiments of the present invention. FIG. 6 is a cross-sectional view of an electrode base assembly with a particular electrode pad structure connected to an electrode base housing therein, according to various embodiments of the present invention. FIG. 6 is a cross-sectional view of an electrode base assembly with a particular electrode pad structure connected to an electrode base housing therein, according to various embodiments of the present invention. FIG. 6 is a cross-sectional view of an electrode base assembly with a particular electrode pad structure connected to an electrode base housing therein, according to various embodiments of the present invention. FIG. 6 is a cross-sectional view of an electrode base assembly with a particular electrode pad structure connected to an electrode base housing therein, according to various embodiments of the present invention. It is sectional drawing of each electrode pad shown to FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. It is sectional drawing of each electrode pad shown to FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. It is sectional drawing of each electrode pad shown to FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. It is sectional drawing of each electrode pad shown to FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. It is sectional drawing of each electrode pad shown to FIG. 16A, FIG. 17A, FIG. 18A, FIG. 19A, and FIG. It is a perspective view of the electrode base housing to which the spring provided with an electrode pad was attached. It is the perspective view and sectional drawing of the electrode pad and bellows-type electrode base housing by embodiment of this invention. It is the perspective view and sectional drawing of the electrode pad and bellows-type electrode base housing by embodiment of this invention. 2A and 2B are a perspective view and a sectional view of an electrode pad and a crushable electrode base housing according to an embodiment of the present invention. 2A and 2B are a perspective view and a sectional view of an electrode pad and a crushable electrode base housing according to an embodiment of the present invention. It is a perspective view of the electrode base housing of this invention which has a periphery sealing rim. FIG. 23 is a cross-sectional view of the electrode base housing shown in FIG. 22, the housing having electrode pads disposed therein. FIG. 23 is a cross-sectional view of the electrode base housing and electrode pad shown in FIG. 22, with the electrode pad being biased against the skin surface. FIG. 3 is a cross-sectional view of an electrode base with wall geometry defined therein. 1 is a cross-sectional view of an electrode base housing of the present invention comprising an electrode pad, the electrode pad being biased against the skin surface. FIG. 25B is a cross-sectional view of the housing and pad arrangement of FIG. 25A in a relaxed mode, defining a wall geometry. 1 is a perspective view of an electrode base housing of the present invention comprising electrode pads, the housing comprising a plurality of closely arranged sealing fingers that surround the electrode pads in an outer circumferential direction. FIG. FIG. 25B is a cross-sectional view of the housing and pad arrangement configuration of FIG. 25C. FIG. 25B is a top view of the housing and pad arrangement of FIG. 25C. FIG. 6 is a cross section of the housing and pad arrangement of the present invention, wherein the housing wall curvature is adapted to capture excess fluid. It is a perspective sectional view of a headset of one embodiment of the present invention arranged on a user's head. It is an enlarged view of the electrode base housing urged | biased by the head. FIG. 3 is a perspective view of a flexible comb member disposed above an electrode base housing, according to an embodiment of the present invention. FIG. 27 is a rear perspective view of the mounting headset in which the flexible comb-shaped member of FIG. 26 protrudes above the outer peripheral band of the headset. FIG. 3 is a perspective front view of a worn headset according to an embodiment of the present invention, where the configuration of the headset and the fitting and placement of the anterior electrode are performed to stimulate specific nerve branches in the forehead region. FIG. 4 shows the dimensions of an electrode of the present invention configured to selectively stimulate nerve branches in the supraorbital region. FIG. 4 is a perspective rear view of a worn headset according to an embodiment of the present invention, where the configuration of the headset and the adaptation and placement of the posterior electrodes are performed to stimulate specific nerve branches in the occipital nerve region. FIG. 4 is a side perspective view of a symmetric member of a headset of the present invention, according to one embodiment of the present invention. It is a perspective view of the headset of the present invention with which it was equipped. It is a perspective front view of the headset of the present invention with a nasal bridge support member attached. 1 is a perspective view of a headset of the present invention worn with associated glasses. FIG. 1 is a perspective view of a headset of the present invention attached with an associated earphone. FIG. 1 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. FIG.

  Described herein are devices and methods comprising a headset with one or more integrated electrodes for applying electrical stimulation to peripheral nerves, cranial nerves and brain regions. The headset of the present invention is a structure attached to the head and has various states (eg, migraine and tension headache, fibromyalgia, depression, post-traumatic stress syndrome, anxiety, obsessive-compulsive disorder) (OCD), functioning as a platform for applying electrical stimulation for the treatment of insomnia, epilepsy, attention deficit hyperactivity disorder (ADHD), Parkinson's disease, Alzheimer's disease, multiple sclerosis, and stroke) it 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.

  The contact between the stimulation electrode and the scalp of the stimulation electrode is a fundamental aspect in the function of the device of the present invention. Optimizing the conductivity between the electrode and the scalp is essential for the proper transfer of current to the target tissue, which is the basis for effective treatment. Inadequate conductivity can result in treatment failure, discomfort and even skin irritation due to high current density “hot spots”. In addition, when the current application to the head region is performed non-invasively, the present inventors can cause a number of problems regardless of the symptom that is the purpose of the current application (for example, hair) Up the target nerve and brain area, regardless of stimulation in the presence of the brain, high levels of hypersensitivity in the scalp and forehead, contact between the electrode and scalp and criticality of conductivity, changes in head size and shape We have also found that the exact placement of the stimulation electrodes.

  Some aspects of the invention relate to features for properly and reliably delivering current from an electrode to a target tissue and for effectively and comfortably treating and evaluating the head region.

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

  FIG. 2 is a perspective view of one 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 front 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 left-right symmetric member 50a by size adjusting mechanisms 32a and 32b configured to be disposed behind the ear. The front member 40 may be configured to be connected to the symmetrical member 50a by size adjusting mechanisms 42a and 42b configured to be disposed in front of the ear on both sides of the head.

  Adjustments to the various head sizes of the headset 10 can be made by symmetrical front adjustment mechanisms 32a, 32b and rearward symmetrical adjustment mechanisms 42a, 42b. When the elastic members 30 and 40 are pulled away from the middle symmetrical member 50a or pushed toward the middle symmetrical member 50a, the size / periphery of the headset 10 increases or decreases. According to certain embodiments, the intermediate symmetric member 50a may be configured to be flexible to self-align to various head shapes.

  The mechanism for adjusting the headset 10 to various head sizes may include only the left and right symmetrical front adjustment mechanisms 32a and 32b or the left and right symmetrical rear adjustment mechanisms 42a and 42b.

  In some embodiments, both the front adjustment mechanisms 32a, 32b and the rear adjustment mechanisms 42a, 42b can improve headset adjustment while maintaining a symmetrical arrangement of the headset on the head. Furthermore, this makes it possible to appropriately adjust the headset size while maintaining an appropriate arrangement of the symmetrical members 50a on the rear side of the corresponding ear.

  The posterior member 30 and the anterior member 40 may each be configured to include an electrode base (also referred to as an electrode system) 60, 70 that, when in an extended state, applies radial force to the electrode base housing 150 to move it to the scalp. And is adapted to ensure an electrical connection between the electrode pad 56a and the skin surface while minimizing undesirable pressure from the headset to the scalp.

  The intermediate left-right symmetric member 50a may be configured to include an electronic circuit 52b. The electronic circuit 52 b may be configured to be electrically connected to the battery 52 a and the electrode units 60 and 70 by the conductive wire 54.

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

  The stimulation circuit may be configured to generate a biphasic charge balance electrical pulse, a single phase electrical pulse and / or a direct current stimulus.

  According to still further features in the described preferred embodiments the stimulation circuit may be configured to generate electrical stimulation within an intensity range of 0-80 mA, 0-40 mA, 0-20 m or 0-15 mA.

  According to still further features in the described preferred embodiments the stimulation circuit generates a stimulation 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.

  According to still further features in the described preferred embodiments the stimulation circuit may be configured to generate stimulation pulses at a frequency of 1-500 Hz, 10-300 Hz, 10-250 Hz, 20-180 Hz or 30-180 Hz. .

  According to further features in the described preferred embodiments, the headset 10 may be configured to transfer current from an external stimulator to the headset electrode by connecting to external electronics and a stimulation circuit. The headset 10 may be configured to connect to at least one external electrode that may be located in various regions of the body. Headset 10 may be configured to connect to external electronics and a processor to move signals from over its substrate sensor to an external processor.

  The battery 52a can be recharged by plugging the charger into the charging port 770 located on the member 50a. The symmetrical member 50a may also be configured with user control and interface 750. In some embodiments, both symmetrical members may be configured with a user interface 750. In some embodiments, other portions of the headset 10 of the present invention (eg, the front member 40 or the back member 30) may be configured with a user interface 750.

  In some embodiments of the present invention, the elastic members 30, 40 of the headset 10 and the electrode pads 56a in the stretch mode while minimizing undesirable pressure from the headset to the scalp in areas that do not hold the electrodes. A radial force may be configured to move 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 positioned higher on the head while maintaining various characteristics (eg, precise placement, adjustment to various head sizes and electrode attachment). It may be constituted as follows. By positioning the headset 10 at a higher position on the head, other nerves and brain regions can be stimulated, and various sensors (eg, EEG sensors) are positioned at higher positions on the head. Will also be possible.

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

  FIG. 4 is a side view of headset 10 having additional semi-rigid and preferably elastic members 590. The member 590 is configured to be vertically connected to the symmetric member 56a, is disposed between the symmetric member 56a, and is adapted to surround the top of the head. Elastic member 590 allows stimulation and positioning of the electrodes and sensors at higher locations on the head.

  FIG. 5 is a side view of the headset 10 configured to include a bifurcated rear 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 wherein the back elastic member 30 does not hold an electrode and its primary function or sole function is to stabilize the headset 10 on the head.

  When necessary, the front elastic member 40 may be configured to include an electrode and the rear member 30 includes an electrode.

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

  Referring 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 member 30 of the headset is maintained with a low elastic modulus. Configured to help maintain a stable three-dimensional configuration. The elastic member 30 may be configured with at least one opening 82 on the inside (facing 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 the 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 of elasticity above the electrode base housing 150 compared to a higher modulus of elasticity in other regions. The member 30 that is parallel to the lower surface of the housing 150 due to a lower coefficient, for example, due to the configuration of the outer surface of the member 30 in a region parallel to the opening 82 that is thinner than other regions due to the opening 82. May be achieved in the region of Thus, when the headset 10 is worn, a local radial force is applied from the member 30 onto the electrode base housing 150 toward the scalp. In contrast, other areas of the elastic member 30 may be configured to have a higher modulus of elasticity, so that the diameter to the scalp in these areas is avoided so that extra pressure is avoided where unnecessary. Directional force is minimized. The region configured to have a higher modulus of elasticity can also help maintain a stable three-dimensional structure of the member 30 and the headset 10, thereby allowing easier mounting and accurate placement of 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. In order to enable connection to the electrode base 60, the elastic member 30 may be configured to include protrusions 96a, 96b. The electrode base 60 may be configured to include holes 98 a and 98 b in the flexible connection 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 into the holes 98a and 98b. The physical connection may comprise other mechanisms. For example, the flexible member 68 can be bonded to the flexible member 30 at the connection site 64.

  FIG. 9 is a cross-sectional view of the electrode base 60 connected to the inside of the elastic member 30. Since 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 headset is attached. Then, the member 30 can be extended and moved to the scalp by applying a radial force to the electrode base housing 150 and the electrode pad 56a (without restriction 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 illustrates a portion of the headset member 30 according to one embodiment. While the electrode system 60 (partially hidden) is integrated into the member 30, only the electrode base housing 150 and the electrode pad 56 a protrude through the openings 82 a and 82 b of the elastic member 30. Flexible connection band 84 and connection site 64 are indicated by dotted lines. The openings 82a, 82b extend beyond the middle edge of the electrode base housing 150 so that the expansion of the member 30 is not constrained by the lateral extension of the openings 82a, 82b when the member 30 is extended. Can extend.

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

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

  12 and 13 show a mechanism for adjusting the placement of the electrode base housing 150 according to further features of the described preferred embodiments.

  FIG. 12 is an internal view of the elastic member 30 according to an embodiment. A flexible connection band 84 is connected to the member 30 by protrusions 96a and 96b (both hidden) extending from the member 30, Snap into a hole in the flexible connection band 84. The mechanical connection of the flexible connection band 84 and the elastic member 30 can be made by other mechanisms (eg, other snap connectors or adhesives). According to one embodiment, the flexible connecting band 84 is in the range of 0.5-5 cm between each hole (more typically 0.5-3 cm, 0.5-2 cm or 0.5- Hole 98 at a distance in the 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 and 92b that are generated from the lower surface thereof. The protrusions 92a, 92b are configured to snap into any of the holes 98 in the flexible connection band 84. The placement of the electrode base housing 60 can be adjusted by snapping the protrusions 92a, 92b into the other hole 98 in the flexible connection band 84.

  FIG. 14 is a cross-sectional view of the electrode pad 56 a disposed in the electrode base 60. The electrode base 60 may be configured to be physically connected to the headset by an elongated flexible connection band 84 and may be electrically connected to the headset electrical circuit by a conductive wire 158. The electrode base 60 may be configured to include at least one electrode base housing 150 that includes a raised perimeter wall surrounding a “floor”, thereby being adapted to receive at least one conductive electrode pad 56a. Cavities 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 disposed partially above or within the electrode base housing 150 floor. The conductive layer is adapted to be electrically connected to an electrical circuit by a 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 steel 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. Such a conductive paint layer can improve the uniformity of the current distribution on the surface of the conductive layer 154, thereby improving the uniformity of the current distribution on the surface of the electrode pad 56a. . The conductive layer 154 is preferably flexible so as not to compromise the overall flexibility of the electrode base 60, thereby ensuring alignment with various head shapes. In certain embodiments, the conductive layer 154 can be limited to that region and can be configured to cover only a portion of the floor surface of the electrode base housing 150. In such a case, the conductive layer 154 may not be flexible and may be composed of various conductive materials known to those skilled in the art. The conductive layer 154 can be configured to be electrically connected to a conductor (cable or wire) 158 and thus can be electrically connected to a 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 include 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 before use. When connected to the housing 150, the electrode pad 56 a is configured to make electrical contact with the conductive layer 154. When the headset is worn, the pad 56a is biased toward the skin surface and can be in electrical contact with the skin surface (skin surface including the scalp) to transfer current to the skin surface.

  Electrode pad 56a and other electrodes associated with the headset receive (sense) current or other biological signals (eg, electroencephalogram (EEG)) from the skin surface and pass it through the headset circuit to the microprocessor. Or may be configured to transmit 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 end edge portion 156 that is thinner than the central region of the pad 56a. The edge 156 may be constructed 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 56 a can be physically reversibly connected to the housing 150 and electrically connected to the conductive layer 154.

  The electrode pad 56 a 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 with 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 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 composed of carbon foil. These two layers may be attached or directly attached. Various manufacturing processes are available (eg, thermal welding, RF welding, ultrasonic welding, gluing or stitching). In order to reduce the current density at the edge of the liquid absorbing 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 edge of layer 254 (which has a lower conductivity relative to layer 258) is reduced. The conductive layer 258 may further include a thin conductive layer 255 of conductive paint. This 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 the layer 258 and the conductive properties of the electrode base housing 150 so that the multilayer electrode pad 56a is electrically connected when attached to the electrode base housing 150. It may be configured to face the layer 154. The conductive printed layer 255 may be configured to have a higher conductivity than the layer 258, thereby reducing the current density at the edge of the layer 258 (excluding the layer 255) while maintaining the current on the layer 258. Dispersion is improved.

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

  Referring now to FIGS. 16A and 16B, the electrode pad 56 a 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 connect to a “loop” (eg, Velcro®) fastening layer 256 disposed in a groove in the inner periphery of the elastic housing 150. It's okay. According to one embodiment, in order to releasably connect the electrode pad 56a to the electrode base housing 150, the user places the electrode pad 56a within the housing 150, thereby enabling the hook layer 252 and loop layer of the electrode pad 56a. 256 can be reversibly attached, which ensures contact between the conductive layer 154 and the liquid absorbent layer 254.

  Referring now to FIGS. 17A and 17B, the electrode pad 56a has three layers (ie, a liquid absorbing layer 254, preferably a flexible conductive layer 258 comprised of a flexible carbon layer, and A “hook” (eg, Velcro® fastening layer 252) connected to at least a portion of the lower peripheral 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, bonding or stitching). According to one embodiment, the electrode base housing 150 is configured to connect to a “loop” (eg, Velcro®) fastening layer 256 disposed in a groove in the inner periphery of the housing 150. Good. According to one embodiment, in order to releasably connect the electrode pad 56a to the electrode base housing 150, the user places the electrode pad 56a within the housing 150, thereby enabling the hook layer 252 and loop layer of the electrode pad 56a. 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 be configured to include a layer of conductive paint that may be printed on a lower surface that is preferably configured to face the conductive layer 154 of the electrode base housing 150. Since this conductive paint 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 reversibly to a corresponding “female” snap connector in the electrode base housing 150 that can be electrically connected to the headset electrical circuit. May be connected physically and mechanically.

  Referring now to FIGS. 18A and 18B, the electrode pad 56a has three layers (ie, a liquid absorbing layer 254, preferably a flexible conductive layer 258 comprised of a flexible carbon layer, and 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, to releasably connect the electrode pad 56a to the electrode base housing 150, the user places the electrode pad 56a in the housing 150, thereby allowing the adhesive hydrogel layer 302 and the conductive layer of the electrode pad 56a to be electrically conductive. The conductive layer 154 can be connected reversibly, and the physical and electrical connection between the electrode base housing 150 and the electrode pad 56a can be stably secured.

  Referring now to FIGS. 19A and 19B, the electrode pad 56a includes a liquid absorbing layer 254, a flexible conductive layer 258 (eg, comprised of a flexible carbon layer), and the conductivity of the housing 150. The double-sided adhesive layer 308 connected to at least a part of the lower peripheral edge of the electrode pad 56 a configured to face the layer 154 may be included. 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 56 a to the electrode base housing 150, the user places the electrode pad 56 a in the housing 150, thereby allowing the double-sided adhesive layer 308 of the electrode pad 56 a and the housing 150. Can be reversibly connected, whereby the physical and electrical connection between the electrode base housing 150 and the electrode pad 56a can be stably secured.

  Referring now 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 composed 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 56 a 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 reversibly contacts 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, current is passed from the conductive layer 154 to the conductive layer 258 and the liquid absorbing layer. 254 and then to the skin surface.

  FIG. 21 is a perspective view of the electrode base 60. According to particular features of the described preferred embodiments, 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 a “self-adjusting” capability for the electrode base housing 150, so that the force applied from the headset to the electrode base housing 150 and the head applied when the headset is mounted. The spring mechanism 320 is compressed or expanded in accordance with the drag force to be applied. In certain embodiments, the spring mechanism 320 may comprise an elastic mechanism or sponge instead of or in addition to a metal or plastic spring.

  21A and 21B are a perspective view and a sectional view, respectively, of an electrode pad 56a and a bellows-type electrode base housing 150 according to an embodiment of the present invention. The electrode base housing 150 may be configured to include a flexible bellows carrier 321 that may be physically connected to the lower portion of the electrode base housing 150 or configured to extend from the lower portion of the electrode base housing 150. . The flexible bellows carrier 321 may be configured to provide a “self-adjusting” capability for the electrode base housing 150, so that the force applied to the electrode base housing 150 from the headset when the headset is attached and The bellows carrier 321 is compressed or expanded in accordance with 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 fold 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 fold 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 a perspective view and a sectional view, respectively, 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. The conical flexible bellows carrier 321 may be configured to physically connect to or extend from the bottom of the electrode base housing 150. The bellows carrier 321 can be configured to provide a “self-adjusting” capability for the electrode base housing 150, so that the force applied to the electrode base housing 150 from the headset and the head when the headset is worn. The bellows carrier 321 can be compressed or expanded in accordance with the applied drag. The bellows carrier 321 may be configured to reversibly repeatedly collapse 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 greatly improve the alignment of the headset and the electrode pad 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 a peripheral sealing rim 360. When hair is stimulated when trying to stimulate various regions of the head non-invasively, a problem occurs because a high impedance layer is generated between the surface electrode and the skin due to the hair. Solid adhesive hydrogels are the most common conductive media used in electrostimulation electrodes. However, in the case of a hydrogel, the use of the hydrogel is not very suitable because it is difficult for the hydrogel to penetrate into the hair layer when hair is present. Other conductive media (eg, semi-liquid conductive gels) may not be convenient for the user because the hair and device must be cleaned / cleaned after each use session.

  In contrast, tap water is more suitable in terms of penetration because it can pass through the hair layer and has no residue. Furthermore, in contrast to conductive gels, tap water is widely available. We need to maintain a substantial water layer against the scalp during treatment, particularly during long-term treatment sessions, to ensure the necessary conductivity and substantially equal current distribution, I found it necessary to avoid. Avoidance of electrode dehydration may be necessary in areas without hair (eg, forehead). As such, electrode pads and arrangements of the present invention are typically free or substantially free of hydrogels.

  FIG. 23 is a cross-sectional view of the electrode base housing 150 with the electrode pads 56a inserted therein.

  FIG. 24 is a cross-sectional view of the electrode base housing 150 with the electrode pads 56a inserted, biased against the skin surface 362. FIG. The housing 150 causes the sealing rim 360 to be biased against the skin surface when pressure is applied perpendicular to the sealing rim 360 relative to the electrode base 60 (not shown) and to the user's skin surface 362. The cavity created between the sealing rim 360 and the user's skin surface 362 and the atmosphere or external environment is adapted to be substantially sealed.

  The sealing rim 360 can be constructed of a flexible material (eg, TPU or silicon) and has a sufficient elastic modulus to maintain a certain level of pressure against the scalp that provides the required sealing effect. May be configured. However, if the elastic modulus is too high, excessive pressure can be applied to the scalp. The sealing rim 360 may be sufficiently flexible so that it can self-align to various head shapes. The sealing rim 360 may be configured to have a high resistance coefficient to assist in stably placing the electrode in place with respect to the scalp. In addition, the sealing rim 360 may be configured to avoid dehydration of water contained in the wet pad and the sealed space, thus enabling a stimulation session to be performed effectively and over a long period of time. Become. If the stimulation electrode is placed in an area where sealing is not required, the sealing rim 360 may be configured to be removable from the electrode base.

  The headset may be configured to include sealing rims having various profiles to ensure proper sealing function at specific skin surfaces and locations. In order 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 should be configured so that it can be used on hairless areas (eg, forehead or other areas of the body) to avoid electrode pad dehydration. Can do.

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

  The outer surface of the flexible outer peripheral wall of the housing 150 has a radial curvature, and the length (B) of the curvature 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 biased against the skin surface 362. The housing 150 seals when the pressure is applied to the user's skin surface 362 in a direction perpendicular to the sealing rim 360 relative to the electrode base 60 (not shown). The cavity 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 silicon) and has a sufficient modulus of elasticity to maintain a certain level of pressure against the scalp that provides the required sealing effect. It may be constituted as follows. However, if the elastic modulus is too high, excessive pressure can be applied to the scalp.

  According to certain embodiments, the hardness level of the sealing rim 360 is 20-50 Shore A, more preferably 20-40 Shore A, and most preferably 30-40 Shore A.

  According to certain embodiments, the elastic modulus (E) (at 100% strain) of the sealing rim 360 is 0.4 MPa to 3 MPa, 0.5 MPa to 2 MPa, or 0.5 MPa to 1.2 MPa. is there.

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

  FIG. 25B is a cross-sectional view of the 25A housing 150, sealing rim 360, and pad 56a arrangement in the relaxed 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 sealing rim curvature height (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 electrode pads 56a. The housing includes a plurality of closely arranged sealing fingers 361 surrounding the electrode pad 56a in the outer circumferential direction. The housing 150 seals when the pressure is applied to the skin surface of the user perpendicular to the sealing finger 361 relative to the electrode base 60 (not shown), causing the sealing finger 361 to be urged against the skin surface. It may be adapted to at least partially seal or at least substantially seal the cavities created between the fingers 361 and the user's skin surface and the atmosphere or external environment.

  The sealing fingers 361 may be made of a flexible material (eg, TPU or silicon) and have a sufficient modulus of elasticity to maintain a certain level of pressure against the scalp that provides the required sealing effect. It may be configured to have.

  According to certain embodiments, the sealing “fingers” 361 are configured to self-align to various surface / skin profiles. The surface tension of the fluid prevents the fluid from flowing between the fingers 361, thereby holding the fluid around the pad 56a.

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

  FIG. 25E is a top view of the arrangement of FIG. 25C. The electrode base housing 150 including the sealing fingers 361 may be configured to include the following dimensions (see FIGS. 25D and 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 housing 150 and pad 56a arrangement of the present invention where the wall curvature 363 of the housing 150 captures and removes 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 biased toward the head, releasing some of its excess fluid into the cavity 366. Thereafter, the fluid contained in the cavity 366 may be absorbed again by the pad 56a and released to the skin surface.

  FIG. 25G is a schematic perspective cross-sectional view of an electrode base housing 150 according to an embodiment of the present invention disposed on the user's head 5 and being biased toward the head. FIG. 25H is an enlarged view of the electrode base housing 150 and the sealing rim 360 being biased toward the head 5.

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

  FIG. 27 is a perspective rear view of the mounting headset in which a flexible comb-shaped member 376 protrudes above the outer peripheral band of the headset 10. While the user wears the headset 10 on his / her head 372, the elongate member 378 is configured to protrude above the electrode in a region containing hair (eg, behind or on the side of the head). May be. The comb-shaped member 376 is configured so that the headset 10 can be easily attached while temporarily and reliably pushing the hair layer under the electrode so that the hair remaining between the electrode and the skin is minimized. It's okay. The flexible comb member 376 may be configured to function like a comb, while the user pushes the headset 10 with the electrode upwards and places it in an operating position on the head 372. The layer of 374 is separated from the scalp, thereby ensuring the necessary conductivity between the electrode and the skin.

  According to still further features in the described preferred embodiments the member 376 may be configured to be removable from the headset 10 so that the user can remove it himself when the user's hair is short. .

  The headset of the present invention is configured to stimulate various regions of the head with electrodes of various shapes and sizes. The headset may include an electrode configured to stimulate the forehead region.

  FIG. 28 is a perspective front view of the headset 10 attached. The headset is configured to stimulate specific nerve branches in the forehead region and the front electrodes 110a, 110b are adapted. These particular nerve branches include the superior pulley nerve 120a, 120b and the orbital nerve 122a, 122b, both of which are surface branches of the trigeminal nerve. The electrodes 122a, 122b may be configured to have a narrow, elongated profile to achieve the desired neural depolarization with minimal stimulation intensity and a sufficient level of perceptual comfort, and the eyebrows 112a and 112b It may be configured to be at least partially aligned with the contour. The electrodes 110a, 110b may be configured to have a minimum size and a specific shape so as to minimize discomfort that occurs when the pain nerve fibers placed on the periosteum of the skull are activated. The electrodes 110a, 110b may also be configured to ensure adequate 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 electrode and in particular its length, it is anticipated that a rotational arrangement of the headset 10 may occur when worn by the user. Therefore, these electrodes may preferably be configured to have a length sufficient to ensure the placement of at least a portion of the electrodes above the target nerve even during such a rotational deviation.

  FIG. 29 shows an embodiment of an electrode 110a that can be configured for stimulation of the supraorbital region. The electrode 110a may include a biocompatible conductive material. The biocompatible conductive material may be configured to face the skin surface and 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 with the following dimensions.
(I) A long part (D _L ) having a length of 20 mm to 55 mm, 25 mm to 50 mm, or 30 mm to 45 mm.
(Ii) A short portion (D _N ) 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, A / L is at least 0.5 mm.
A is an area delimited by the dotted line K and the concave surface.
L is the length of the line K (between the boundary points G and F), (L) is at least 10 mm, on the concave contour on the periphery of the electrode 110a on the side opposite the concave contour E Between the first point and the second point, and aligned perpendicular to the contour E at the first point, this line having a length H.
In the whole concave 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 two electrodes configured to stimulate the orbital region may be in the range of 5-45 mm, 8-35 mm, or 8-25 mm. Additional electrodes may be placed on the headset to stimulate other nerves (eg, zygomatic or auricular temporal nerve). The headset may also include an electrode configured to stimulate the occipital region.

  FIG. 30 shows that electrodes 146a, 146b are placed behind the headset 10 (opposite the occipital region) to stimulate nerves in the occipital region 140 (eg, the left large occipital nerve 142a and the right large occipital nerve 142b). 1 shows an embodiment configured in such a way. Additional electrodes may be placed in the headset and configured to stimulate other nerves in the head region (eg, left and right minor occipital nerves 143a, 143b).

  In order to stimulate the large occipital nerve branches 142a, 142b, these electrodes may be configured to be positioned above the nerve branches at approximately the height of the occipital ridge, where the large occipital nerve branches are It becomes the surface after penetrating the trapezius fascia. When the lower side of this anatomical region is stimulated, the superior cervical muscles can contract adversely, while when the higher region is stimulated, the scapula can contract adversely, and the nociceptive nerve fibers of the cranial periosteum May cause pain. This ensures that the electrodes are properly placed and properly sized to ensure effective stimulation with a high level of perceptual comfort and 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 20-50 mm in length and 8-40 mm in height, with the electrodes 146a, 146b having a distance from the occipital midline of 5-5. It may be placed at a location of 35 mm. More typically, the length of the electrodes 146a, 146b may be in the range of 25-45 mm, the height may be in the range of 10-25 mm, and the electrodes 146a, 146b are from the occipital midline. You may arrange | position in the place whose distance is 8-25 mm.

  FIG. 31 is a side perspective view of a symmetric member 50a that is part of a headset of the present invention, according to one embodiment. According to particular features of the described preferred embodiments, the member 50a is configured to be rigid (preferably semi-rigid) and is adapted to be curved and aligned 408 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 such that a user without medical expertise can be placed on the head accurately and repeatably and intuitively. 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 stimulation on the periosteum of the skull or muscles (eg, frontal, temporal muscles, shoulders) Accurate electrode placement is particularly important because it can cause unwanted movement contractions of the upper or upper neck muscles.

  The symmetric rigid and preferably semi-rigid member 50a allows the user to place the headset 10 on his / her head 500 in a substantially accurate and repeatable manner. May be configured. When the curvilinear symmetrical members 50a are arranged behind and above both ears, the outer circumference (rotation) and longitudinal arrangement of the headset 10 are determined with respect to the head 500.

  Headset 10 may be configured to include a recess 410 at a forward portion thereof configured to align above nasal bridge 506 with the midline between the eyebrows. In order to ensure proper perimeter (rotation) and longitudinal placement of the headset 10 relative to the head 500 without the need for a mirror, the user places his / her thumb on the nose bridge 506 and his / her (same hand). One of the fingers) can be placed on the recess 410 to ensure the correct placement of the headset 10.

  The outline of the front 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 so that the user can control the front elastic member 40 of the headset 10. When aligned above the eyebrows, the rotation and longitudinal orientation of the headset is determined.

  In order to suit each particular user, the rotational position of the symmetrical semi-rigid member 50a relative to the headset 10 can be individually adjusted. Different sizes and shapes of semi-rigid members 50a can be selected to optimally adjust the placement direction of the headset 10. In order to adjust the front longitudinal direction arrangement direction of the headset, the front elastic member 40 having various outer shapes can be selected. The position of the recess 410 can be adjusted, or the headset 10 and its integrated electrode can be configured for asymmetric alignment as required.

  The rear elastic member 30 of the headset 10 may be configured to have a concave shape that may be aligned above the occipital protrusion and the nodal line, thereby allowing the longitudinal arrangement of the headset 10 (more specifically, The longitudinal elastic member) may be determined.

  FIG. 33 is a perspective front view of headset 10 with “nasal bridge” member 510. The “nasal bridge” member 510 may be configured to be disposed within the central region of the elastic member 40. The “nasal bridge” member 510 may be rigid or semi-rigid and may have two elongate sites adapted to be aligned on the top of the nose and on both sides of the nasal bridge. By positioning the “nasal bridge” member on the nose, the user can determine the rotation and longitudinal orientation 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 an individual user. The “nasal 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 glasses 520. The glasses 520 may be adapted to be connected to the front elastic member 40. In some embodiments, the glasses 520 are
Reversibly and repeatably removable from the headset 10,
-Including various lenses (for example, optical lenses for improving visual acuity, sunglasses, or non-optical transparent lenses)
Including dark lenses that can be used to block external light, for example to assist or relax in the event of migraine,
It may be constituted as follows.

  FIG. 35 is a perspective view of the headset 10 having earphones (for example, symmetrical earphones 522). In some embodiments, the symmetrical earphone 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 symmetric member 50a may be configured to allow the earphone 522 to be reversibly and repeatably removed from the symmetric member 50a.

  In some embodiments, the symmetric 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 drawing 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 together 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 when a user sends 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 audio instructions regarding the condition of the headset 10 can also be presented to the user.

  Headset 10 may be configured to communicate wirelessly with mobile phone 570. The cellular phone interface can be used to present various data wirelessly sent from the headset 10 (eg, visual and audio instructions about the status of the headset 10 and usage logs).

  Headset 10 may be configured to communicate wirelessly with laptop / PC 580. The cellular phone interface can be used to present various data wirelessly sent from the headset 10 (eg, visual and audio instructions about the status of the headset 10 and usage logs).

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 skilled in the art (for example, Bluetooth (registered trademark) communication).
As used herein and in the appended claims, the term “monolithic” means functioning structurally as a single, at least semi-rigid whole.

  As used herein and in the appended claims, “monolithically attachable” to a headset, headset frame, etc. means that the headset, headset frame, etc. is a single at least A semi-rigid structure that can be mounted as a whole.

  As used herein and in the appended claims, terms such as “mode of operation” for a headset or headset component refer to the appropriate rotational and longitudinal directions with electrical stimulation applied. Refers to a headset or headset component that is adapted to the user's head in the arrangement of

  As used herein and in the appended claims, the terms “wearing mode”, “wearing”, etc. for a headset or headset component are appropriate when electrical stimulation is applied. Refers to a headset or headset component that is adapted to the user's head in a rotational and longitudinal arrangement.

  As used herein and in the appended claims, the term “unitary” refers to a structure that functions as a single overall structure. This term may apply particularly to flexible structures (eg electrode pads).

  It will be understood that certain features of the invention described in the context of separate embodiments for clarity may be combined with a single embodiment. Conversely, various features of the invention described in the context of a single embodiment for simplicity may be used separately or in any additional combination. Similarly, the content of a claim that is dependent on one or more specific claims may generally be dependent on other unspecified claims, or does not include any specific obvious incompatibility between the two You may combine with the contents.

  While the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will occur. Accordingly, the present invention is intended to embrace all alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

Claims (34)

A headset used in the delivery of electrical stimulation to the skin surface of a user's head, the headset comprising:
(A) an outer peripheral headset body, the main body having a monolithic frame adapted to follow the outer circumference of the head of the user, the main body adapted to be connected to a power source; The headset body includes an elastic arrangement disposed on at least a portion of an outer periphery of the headset body, the elastic arrangement configured to extend along the outer periphery. An adapted outer headset body,
(B) at least one electrode base mechanically and at least semi-rigidly connected to the headset body and electrically associated with the electrical circuit, the electrode base comprising at least one electrode pad; An electrode base adapted to receive; and
With
The headset body and the base are adapted to direct the electrical stimulation surface of the pad to the skin surface when worn by the user;
The elastic arrangement is adapted such that the elastic arrangement biases the electrode base to the skin surface in a radial direction during the wearing so that the electrode pad is in physical and electrical contact with the skin surface;
The elastic arrangement and the electrode base are adapted to fix an outer peripheral position of the electrode base relative to the frame in a natural position for variable extension of the elastic arrangement;
headset.   The outer peripheral headset body has a front portion adapted to be around the front portion of the head, and at least one of the at least one electrode base is a front electrode disposed on the front portion. The headset of claim 1 which is a base.   The headset according to claim 2, wherein the front part is a front mechanical element physically different from the outer peripheral headset body.   The headset of claim 3, wherein the front mechanical element extends up to a maximum of 40%, a maximum of 35%, a maximum of 30%, or a maximum of 20% of the outer periphery of the outer peripheral headset body.   The forward mechanical element ranges from 10% to 40%, 15% to 40%, 20% to 40%, 25% to 40%, or 25% to 35% of the outer periphery of the outer peripheral headset body. The headset described in.   The outer peripheral headset body has a rear portion adapted to follow a periphery of a rear portion of the head, and at least one of the at least one electrode base is a rear electrode disposed on the rear portion. The headset according to any one of claims 1 to 5, which is a base.   The headset according to claim 6, wherein the rear portion is a rear machine element physically different from the outer peripheral headset body.   8. The headset of claim 7, wherein the headset spans up to 40%, up to 35%, up to 30% or up to 20% of the outer periphery of the outer headset body.   8. The posterior machine element ranges from 10% to 40%, 15% to 40%, 20% to 40%, 25% to 40% or 25% to 35% of the outer periphery of the outer peripheral headset body. The headset described in.   10. The front and rear mechanical elements generally span 45% to 75%, 50% to 75%, 55% to 75%, or 55% to 70% of the outer periphery. headset.   11. The frame according to any one of claims 1 to 10, wherein the frame includes at least a semi-rigid side component disposed on the frame in a bilaterally symmetrical manner, and forms a side portion of an outer periphery of the headset body. Headset.   The side components generally range from 15% to 50%, 20% to 50%, 25% to 50%, 30% to 50%, 35% to 50% or 30% to 45% of the outer periphery. The headset according to claim 8 or claim 9.   13. The side component according to claim 11 or 12, wherein each of the side components comprises an element that is disposed substantially perpendicular to the outer periphery and is adapted to follow the back of the user's ear in a wearing mode. Headset.   The headset according to any one of claims 11 to 13, wherein an outer periphery rigidity of the side component exceeds an outer periphery rigidity of the front part and the rear part.   The headset according to any one of claims 11 to 14, wherein the outer peripheral elasticity of the front part and the rear part exceeds the outer peripheral elasticity of the side component. The frame comprises a positioning system for angular and longitudinal positioning of the headset body, the positioning system comprising at least one at least semi-rigid side component, the side component comprising:
(I) a first elongate element that forms a portion of the outer periphery and is adapted to be along above the user's ear to determine the longitudinal positioning;
(Ii) a second element positioned substantially perpendicular to the elongate element and adapted to follow the back of the ear to determine the angular positioning of the headset body;
Having
The headset according to any one of claims 1 to 15.   17. The headset according to any one of the preceding claims, wherein the frame comprises at least a first symmetrical size adjustment mechanism adapted to fixedly adjust the outer periphery of the headset body. .   18. A headset according to claim 17, wherein the adjustment mechanism is rigid or at least semi-rigid.   The frame includes a first symmetric size adjustment mechanism and a second symmetric size adjustment mechanism adapted to adjust the outer periphery of the headset body, the first adjustment mechanism comprising: 19. A headset according to claim 17 or claim 18, wherein a side component is connected to the front portion and the second adjustment mechanism connects the side component to the rear portion.   20. The first adjustment mechanism and the second adjustment mechanism are adapted to adjust the outer periphery of the headset body while the outer peripheral position of the side component is fixed. The listed headset.   The frame is adapted such that the frame is substantially inelastic along at least 30%, at least 40%, at least 50%, or at least 60% of the length of the outer periphery. Item 21. The headset according to any one of items 20.   The headset body is adapted to juxtapose a contact surface of an electrical device to the skin surface, and the elastic arrangement is configured to radially bias the electrical device toward the skin surface to contact the electrical device contact surface. Is adapted to be in physical contact with the skin surface, and the elastic arrangement is adapted such that the outer peripheral position of the electrical device is fixed in a unique position due to variable stretching of the elastic arrangement. The headset according to any one of claims 1 to 21.   23. The headset of claim 22, wherein the electrical device comprises a sensor adapted to sense body parameters associated with the user's head. And further comprising at least one electrode pad,
(A) a water-absorbing layer having a biocompatible contact surface, wherein the contact surface is adapted to be juxtaposed to the skin surface;
(B) An electrode support attached to the water absorption layer, the support comprising at least one conductive material or element, wherein the conductive material or element is filled with water in the water absorption layer An electrode support that is electrically connected to the water-absorbing layer when
With
The biocompatible contact surface is:
(I) a long portion (D _L ) having a maximum length of 20 mm to 55 mm;
(Ii) having a short part (D _N ) having a maximum length of 10 mm to 25 mm,
The first side of the periphery of the biocompatible contact surface has a generally concave outer shape having a concave surface defined by a first boundary point and a second boundary point disposed at opposite ends of the concave surface. Have

And
A is a region delimited by the line and the concave surface;
L is the length of the line between the boundary points;
The length (L) is at least 10 mm;
A line is disposed between a first point on the concave contour and a second point on the periphery on the opposite side of the concave contour, with respect to the contour at the first point. Vertically aligned, having a length H,
In the whole of the concave outer shape,

And
H _max is the maximum value of H in the whole,
H _min is the minimum value of H in the whole.
The headset according to any one of claims 1 to 23. The at least one electrode pad comprises:
(A) a water-absorbing layer having a biocompatible conductive contact surface, wherein the contact surface is adapted to be juxtaposed to the skin surface;
(B) a conductive layer having a wide range of first surfaces attached to the water absorbing layer, the conductive layer comprising at least one conductive material or element, the conductive layer comprising: Current is transferred from the extensive second surface distal to the first surface to the water absorbing layer through the first surface, the water absorbing layer, and the conductive layer forming a monolithic structure. A conductive layer that is adapted; and
The headset according to any one of claims 1 to 24, comprising:   26. A headset according to claim 25, wherein the water absorbing layer comprises at least one material selected from the group consisting of nonwoven fabric, felt or sponge.   27. A headset according to claim 25 or claim 26, wherein the conductive layer has a conductive paint layer on the second surface, preferably arranged in a mesh pattern.   28. A headset according to any one of claims 25 to 27, wherein the conductive layer comprises a carbon foil.   29. The headset according to claim 28, wherein the conductive carbon film or carbon foil has a resistance of 1 to 180 [Omega] / □ or 30 to 100 [Omega] / □.   30. A headset according to any one of claims 28 or 29, wherein the conductive carbon film or carbon foil has a thickness in the range of 30-1500 microns or 50-200 microns.   The headset according to any one of claims 27 to 30, wherein the water absorption layer and the conductive layer have the conductive paint layer forming an integral structure. The electrode base is
(A) A housing having a floor and a flexible outer peripheral member surrounding the floor, and having a flexible outer peripheral wall extending generally above the periphery of the floor, the wall being an outer peripheral rim The housing and the floor and the flexible outer member form a cavity adapted to receive a conductive electrode pad;
(B) A conductive material disposed at least above or within the floor, wherein the conductive layer is adapted to be electrically associated with an electrical circuit by a conductor and the pad is inserted A conductive material adapted to be in electrical communication with the electrode pad;
Having
The rim and the flexible outer wall bias the rim toward the skin surface when pressure is applied to the electrode base toward the skin surface of the user substantially perpendicular to the rim. An electrically conductive material adapted to be substantially fluid sealed between the cavity and the atmosphere or external environment,
32. The headset according to any one of claims 1 to 31.   In the rim of the electrode base, a plurality of sealing fingers having a volume are arranged in an outer circumferential direction, and the sealing fingers are arranged when the rim is urged toward the skin surface. 35. The headset of claim 32, wherein the headset is adapted to substantially seal between the volume and a volume external to the sealing finger.   The rim comprises or consists essentially of a plurality of sealing fingers arranged in the outer circumferential direction, wherein the sealing fingers are arranged when the pressure is applied. 35. The headset of claim 32, wherein the sealing fingers are adapted to substantially seal between the cavity and an external volume of the rim.

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