WO2021241308A1 - ウェアラブル装置及び検出方法 - Google Patents

ウェアラブル装置及び検出方法 Download PDF

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Publication number
WO2021241308A1
WO2021241308A1 PCT/JP2021/018663 JP2021018663W WO2021241308A1 WO 2021241308 A1 WO2021241308 A1 WO 2021241308A1 JP 2021018663 W JP2021018663 W JP 2021018663W WO 2021241308 A1 WO2021241308 A1 WO 2021241308A1
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WO
WIPO (PCT)
Prior art keywords
layer
wearable device
electrode
skin
conductive gel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2021/018663
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English (en)
French (fr)
Japanese (ja)
Inventor
克敏 沢田
昌泰 藤岡
俊 青木
翔アドナース 高橋
伸敏 小林
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JSR Corp
Original Assignee
JSR Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by JSR Corp filed Critical JSR Corp
Priority to CN202180038539.4A priority Critical patent/CN115666386A/zh
Priority to JP2022526908A priority patent/JP7730318B2/ja
Publication of WO2021241308A1 publication Critical patent/WO2021241308A1/ja
Priority to US18/058,783 priority patent/US20230086296A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/332—Portable devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/68335—Means for maintaining contact with the body using adhesives including release sheets or liners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02141—Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits

Definitions

  • the embodiment of the present invention relates to a wearable device and a detection method.
  • an object of the present invention is to provide a wearable device and a detection method capable of stably acquiring continuous biological information.
  • the present invention is a wearable device for acquiring biometric information of a subject, the detection unit for detecting the biometric information, and the first direction of the detection unit.
  • a first layer having a conductor that is electrically connected to the detection unit and has flexibility, and the first layer that is arranged in the first direction of the first layer.
  • It is a wearable device including a harder second layer and a third layer including an electronic component arranged in the first direction of the second layer and electrically connected to the conductor.
  • the present invention is a wearable device for acquiring biological information of a subject, and is a second layer having water absorption and being arranged in the first direction of the first layer and having waterproofness. And the conductive gel portion arranged in the first direction of the second layer and in contact with the skin of the subject, and the conductive gel portion arranged in the first direction of the conductive gel portion.
  • a third flexible portion having an electrode portion having an electrode electrically connected to the portion and a conductor arranged in the first direction of the electrode portion and electrically connected to the electrode portion.
  • a wearable device comprising a layer of the third layer and a fourth layer including electronic components arranged in the first direction of the third layer and electrically connected by the conductor.
  • the present invention is a detection method including detecting an abnormality of the subject based on the biological information acquired by using the wearable device.
  • the present invention it is possible to provide a wearable device and a detection method capable of stably acquiring continuous biological information.
  • FIG. 1 is a diagram showing an example of the structure of the wearable device 100 according to the embodiment.
  • FIG. 2 is a diagram showing an example of the structure of the flexible substrate 110 and the electronic component unit 120 according to the embodiment.
  • FIG. 3 is a diagram showing an example of wiring on the flexible substrate 110 and the rigid substrate 121 according to the embodiment.
  • FIG. 4 is a diagram showing an example of the structure of the adhesive portion 130 according to the embodiment.
  • FIG. 5 is a diagram for explaining a method of attaching the wearable device 100 according to the embodiment.
  • FIG. 6 is a diagram showing an example of the structure of the adhesive portion 130 according to the modified example.
  • the wearable device and the detection method according to the embodiment will be described with reference to the attached drawings.
  • the embodiments described below are not limited to the following description.
  • the embodiments described below can be combined with other embodiments or conventional techniques as long as the configurations do not conflict with each other.
  • the embodiment described below can include the configuration described in Japanese Patent No. 6539827.
  • the configuration shown below is not limited to the contents shown below.
  • the dimensions and angles of each part shown below can be appropriately changed as long as the functions of the wearable device are not impaired.
  • FIG. 1 is a diagram showing an example of the structure of the wearable device 100 according to the embodiment.
  • FIG. 1 illustrates a perspective view of the wearable device 100.
  • the wearable device 100 is a device (sensor device) that acquires biometric information of the subject.
  • the wearable device 100 is formed in a substantially rectangular shape (strip shape) and is used by being attached to the skin (skin) of a subject.
  • the target person is a person who is a target for acquiring biometric information, and corresponds to a person (wearer) who wears the wearable device 100.
  • the "substantially rectangular” is not only a rectangle having four corners (vertices) and whose opposite sides are parallel to each other, but also a shape in which the four corners are rounded, for example, as shown in FIG. , Includes a shape such that each side has a slight curvature.
  • the wearable device 100 detects an electrocardiographic signal as biometric information.
  • the wearable device 100 that acquires an electrocardiographic signal will be described, but the embodiment is not limited to this.
  • the wearable device 100 may be a sensor device that acquires biological information other than electrocardiographic signals such as body temperature and blood pressure. Further, the wearable device 100 can acquire not only one type of biometric information but also a plurality of types of biometric information.
  • the wearable device 100 has a flexible substrate 110, an electronic component portion 120, and an adhesive portion 130.
  • the flexible substrate 110, the electronic component portion 120, and the adhesive portion 130 will be described in detail later.
  • FIG. 1 illustrates a case where the wearable device 100 has a substantially rectangular shape, but the embodiment is not limited to this.
  • the wearable device 100 can be formed into any shape such as a square, a circle, and an ellipse. Among these shapes, the wearable device 100 preferably has a substantially rectangular or elliptical shape, and a substantially rectangular or elliptical shape having an aspect ratio (ratio of the major axis to the minor axis) of 1.1 or more is particularly preferable.
  • the wearable device 100 having such a shape, since the distance between the electrodes can be widened in the same area, continuous biological information can be acquired more sensitively. Further, it is desirable that the end shape of the wearable device 100 is not angular. With such a shape, it does not easily come off from the subject's skin and does not cause discomfort.
  • the wearable device 100 when the wearable device 100 is attached to the skin of the target person, the direction away from the skin may be described as “upper”. “Upper” is an example of the first direction. In addition, the direction opposite to “upper” may be described as “lower”. “Bottom” is an example of the second direction.
  • FIG. 2 is a diagram showing an example of the structure of the flexible substrate 110 and the electronic component unit 120 according to the embodiment.
  • the upper part of FIG. 2 illustrates a top view of the flexible substrate 110 and the electronic component unit 120.
  • a front view of the flexible substrate 110 and the electronic component unit 120 is illustrated.
  • the lower part of FIG. 2 illustrates a bottom view of the flexible substrate 110 and the electronic component unit 120.
  • the flexible substrate 110 is a substrate that has flexibility so that it can flexibly follow the movement of the person who wears the wearable device 100, and a conductor is wired.
  • the flexible substrate 110 is, for example, an FPC (Flexible Printed Circuits) formed in a substantially rectangular shape.
  • the flexible substrate 110 can be formed by using any material such as a polyimide resin, a polyamide resin, a polyester resin, an epoxy resin, and an acrylic resin.
  • the flexible substrate 110 preferably has a thickness of 0.10 mm or more and less than 0.80 mm, and more preferably 0.15 mm or more and less than 0.60 mm.
  • the layer having the flexible substrate 110 is also referred to as a "flexible layer".
  • the flexible substrate 110 includes a conductor on the first surface (upper surface) for electrically connecting each electronic component mounted on the wearable device 100. Further, the flexible substrate 110 includes three electrodes 111, 112, 113 on the second surface (bottom surface) opposite to the first surface.
  • the electrodes 111 and 112 as the positive electrode and the negative electrode and the electrode 113 located between the positive electrode and the negative electrode as the reference electrode, it becomes possible to acquire biometric information more stably.
  • Electrodes 111, 112, 113 are electrodes for detecting an electrocardiogram (ECG) of a subject. Each of the electrodes 111, 112, 113 is electrically connected to a conductor wired on the upper surface of the flexible substrate 110 via a through hole (through hole).
  • the layer having the three electrodes 111, 112, 113 is also referred to as an “electrode layer”.
  • the electrode layer is an example of a "detection unit" that detects biological information.
  • FIG. 2 has described the case where there are three electrodes for detecting an electrocardiographic signal, the embodiment is not limited to this.
  • the number of electrodes for electrocardiographic signal detection can be set as needed.
  • the electronic component unit 120 includes various electronic components that are electrically connected to a conductor wired on the upper surface of the flexible substrate 110 and control processing in the wearable device 100.
  • the electronic component unit 120 controls power supply to each unit in the wearable device 100, amplification and collection of the electrocardiographic signal detected by the electrodes 111, 112, 113, and output of the collected electrocardiographic signal. ..
  • the layer having the electronic component portion 120 is also referred to as an "electronic component layer".
  • the electronic component portion 120 is laminated on the hard substrate 121.
  • the rigid substrate 121 is a substrate that is laminated on the flexible substrate 110 and supports the electronic component portion 120.
  • a hard substrate such as a paper phenol substrate, a paper epoxy substrate, a glass composite substrate, a glass epoxy substrate, or a glass polyimide substrate can be arbitrarily applied.
  • the hard substrates paper epoxy substrates, glass epoxy substrates, and glass polyimide substrates are preferable, and glass epoxy substrates are particularly preferable.
  • the hard substrate 121 preferably has a thickness of 0.30 mm or more and less than 3.0 mm, and more preferably 0.50 mm or more and less than 2.0 mm. With such a hard substrate, it becomes easy to support the electronic component portion 120, so that it becomes possible to acquire biometric information more stably.
  • the electronic component portion 120 By being laminated on the hard substrate 121, the electronic component portion 120 is more durable against bending than when it is directly laminated on the flexible substrate 110 or when it is installed inside the flexible substrate 110. Sex improves. As a result, the wearable device 100 reduces the risk of damage such as the solder of the electronic component portion 120 being detached and broken due to bending, so that continuous biometric information can be stably acquired.
  • the hard substrate 121 is arranged at the end of the flexible substrate 110.
  • the number of wirings on the flexible substrate 110 is reduced to several wirings toward the electronic component portion 120 (hard substrate 121), so that the wirings can be simplified.
  • the wearable device 100 can reduce the risk of disconnection of the wiring, so that continuous biometric information can be stably acquired.
  • the hard substrate 121 is arranged at a position corresponding to the electrode 112 of the flexible substrate 110, and more preferably arranged at a position corresponding to the electrodes 112 and 113.
  • the electrodes 112 and the like become robust against bending.
  • the wearable device 100 reduces the risk of damage to the electrodes 112 and the like due to bending, so that continuous biological information can be stably acquired.
  • the area of the hard substrate 121 is preferably 5 to 50% with respect to the area of the flexible substrate 110, and more preferably 20 to 40% with respect to the area of the flexible substrate 110.
  • the area of the hard substrate 121 is the area of the surface of the rigid substrate 121 facing the flexible substrate 110.
  • the area of the flexible substrate 110 is the area of the surface of the flexible substrate 110 facing the hard substrate 121.
  • the content described in FIG. 2 is merely an example, and is not limited to the content shown in the illustration.
  • the electronic component portion 120 can be laminated on any member as long as it is a member that is harder (harder to bend) than the flexible substrate 110. That is, the electronic component unit 120 is laminated on the "isolation layer" for separating the flexible substrate 110 from the bending.
  • the isolation layer for example, a flexible substrate made of a material harder than the flexible substrate 110, a flexible substrate made of a material thicker than the flexible substrate 110, and the like can be arbitrarily applied.
  • the isolation layer is also referred to as a "support layer” that supports the electronic component unit 120.
  • each part described in FIG. 2 are not limited to the above-mentioned materials.
  • the materials of the flexible substrate 110, the electrodes 111, 112, 113, the electronic component portion 120, and the hard substrate 121 known materials can be arbitrarily applied as long as the functions of the above-mentioned parts are not impaired.
  • FIG. 3 is a diagram showing an example of wiring on the flexible substrate 110 and the rigid substrate 121 according to the embodiment.
  • the upper part of FIG. 3 illustrates the wiring in the top view of the hard substrate 121. In the middle of FIG. 3, the wiring in the top view of the flexible substrate 110 is illustrated.
  • the lower part of FIG. 3 illustrates the wiring in the front view of the flexible substrate 110 and the rigid substrate 121.
  • a plurality of lead wires 140 are arranged on the upper surface of the hard substrate 121.
  • the lead wire 140 electrically connects various electronic components included in the electronic component section 120. It should be noted that the wiring branched into three lines shown in the upper part of FIG. 3 is merely an example, and the embodiment is not limited to this.
  • the lead wire 140 on the hard substrate 121 is appropriately insulated and connected to the lead wire 140 on the flexible substrate 110.
  • Lead wires 140 for connecting the three electrodes 111, 112, 113 and the electronic component unit 120 are arranged on the upper surface of the flexible substrate 110, respectively. Further, through holes are formed at the positions 110A, 110B, and 110C of the flexible substrate 110, respectively.
  • the lead wire 140 is connected to the three electrodes 111, 112, 113 via through holes formed at each position.
  • the lead wires 140 extending from the electrodes 111, 112, and 113 are individually connected to the lead wires 140 on the hard substrate 121 in an insulated state.
  • FIG. 3 the content described in FIG. 3 is merely an example, and is not limited to the content shown in the figure.
  • the lead wires 140 arranged on the upper surface of each substrate are shown separately from each substrate, but this is intended to clearly indicate the lead wires 140, and both are actually shown. Are not separated.
  • the lead wires 140 on the hard substrate 121 are bundled at "one place" has been described, but the lead wires 140 may be bundled at several places and connected to the flexible substrate 110. However, in order to simplify the wiring, it is preferable that the number of bundled parts is small.
  • FIG. 4 is a diagram showing an example of the structure of the adhesive portion 130 according to the embodiment.
  • the upper part of FIG. 4 illustrates a front view of the adhesive portion 130.
  • the bottom view of the adhesive portion 130 is illustrated in the lower part of FIG.
  • the adhesive portion 130 is a member that is arranged on the bottom surface of the flexible substrate 110 and has an adhesive force for attaching the flexible substrate 110 and the electronic component portion 120 to the skin of the subject.
  • the adhesive portion 130 has five layers: a waterproof layer 131, a conductive gel layer 132, a waterproof layer 133, a water absorption layer 134, and a skin adhesive layer 135.
  • the waterproof layer 131 is a layer that is arranged on the bottom surface of the flexible substrate 110 (electrode layer) and has waterproof and insulating properties.
  • the waterproof layer 131 contains a material having excellent waterproof properties such as polyester resin, polyurethane resin, polyethylene resin, polypropylene resin, and nylon resin.
  • the waterproof layer 131 has holes for contacting the electrodes 111, 112, 113 with the conductive gels 132A, 132B, 132C described later.
  • the waterproof layer 131 has a circular hole having a diameter of 15 mm.
  • the conductive gel layer 132 is a layer that is arranged on the bottom surface of the waterproof layer 131, is in contact with the skin of the subject, and is electrically connected to each of the electrodes 111, 112, 113.
  • the conductive gel layer 132 has three conductive gels 132A, 132B, 132C.
  • the conductive gel layer 132 is an example of a "detection unit" that detects biological information.
  • Each conductive gel 132A, 132B, 132C is a hydrogel (hydrous gel) having conductivity.
  • each conductive gel 132A, 132B, 132C has a circular shape with a diameter of 17 mm.
  • the conductive gel 132A is arranged on the bottom surface of the electrode 111 and is electrically connected to the electrode 111.
  • the conductive gel 132B is arranged on the bottom surface of the electrode 112 and electrically connected to the electrode 112.
  • the conductive gel 132C is arranged on the bottom surface of the electrode 113 and is electrically connected to the electrode 113.
  • the conductive gel layer 132 nothing may be arranged or any member may be arranged in the region where the three conductive gels 132A, 132B, 132C do not exist. If nothing is arranged, the waterproof layer 131 and the waterproof layer 133 will be directly adhered to each other. Further, when arranging an arbitrary member, it is preferable to arrange a member having insulating property and waterproof property.
  • the waterproof layer 133 is arranged on the bottom surface of the conductive gel layer 132 and has waterproof and insulating properties.
  • the waterproof layer 133 includes a material having excellent waterproof properties such as polyester resin, polyurethane resin, and nylon resin.
  • the waterproof layer 133 has holes for contacting the conductive gels 132A, 132B, 132C with the skin of the subject. In the example of FIG. 4, the waterproof layer 133 has a circular hole having a diameter of 15 mm.
  • the bottom surface of the conductive gel layer 132 corresponds to the surface of the conductive gel layer 132 opposite to the surface adjacent to the electrode layer.
  • the water absorption layer 134 is a layer that is arranged on the bottom surface of the waterproof layer 133 and has water absorption.
  • the water absorption layer 134 includes a non-woven fabric.
  • the water absorption layer 134 is not limited to the non-woven fabric, and may be made of, for example, a fiber having water absorption.
  • a fiber it is preferable to use a polyester resin, a polyurethane resin, a polypropylene resin, a nylon resin or the like as a material, and it is particularly preferable to use a polyurethane resin or a polypropylene resin as a material.
  • the fiber is made of such a material, it has excellent breathability and elasticity, so that the effect of the water absorption layer 134 described later is easily exhibited. Further, the bottom surface of the waterproof layer 133 corresponds to the surface of the waterproof layer 133 opposite to the surface adjacent to the conductive gel layer 132.
  • the water absorption layer 134 has holes for contacting the conductive gels 132A, 132B, 132C with the skin of the subject.
  • the water absorption layer 134 has a circular hole having a diameter of 22 mm.
  • the water absorption layer 134 has an effect of absorbing sweat (moisture) generated on the skin of the subject and dissipating it to the outside of the wearable device 100. Therefore, the water absorption layer 134 prevents the hydrogel (conductive gel layer 132) from absorbing moisture and expanding, so that discomfort due to expansion can be reduced. In addition, the water absorption layer 134 prevents the hydrogel from expanding, thereby reducing the possibility of the hydrogel peeling from the adjacent layer. As a result, the wearable device 100 can reduce the possibility of being peeled off from the wearer's skin due to sweat, and can be continuously attached for up to about 2 weeks.
  • the wearable device 100 can reduce the influence on the human body (skin) such as cytotoxicity, sensitization (allergic reaction), and irritation.
  • skin such as cytotoxicity, sensitization (allergic reaction), and irritation.
  • the influence on the human body can be further reduced.
  • the holes in the water absorption layer 134 are larger than the holes in the waterproof layer 133. Therefore, since the end (edge) of the hole of the water absorption layer 134 and the conductive gels 132A, 132B, 132C are separated from each other, the water absorbed by the water absorption layer 134 passes through the end of the hole and the conductive gels 132A, 132B, respectively. , The possibility of being absorbed by 132C can be reduced.
  • the skin adhesive layer 135 is arranged on the bottom surface of the water absorption layer 134 and is a layer that can be adhered to the skin of the subject.
  • the skin adhesive layer 135 contains an acrylic adhesive or a hydrocolloid.
  • the skin adhesive layer 135 has holes for contacting the conductive gels 132A, 132B, 132C with the skin of the subject.
  • the waterproof layer 133 has a circular hole having a diameter of 22 mm.
  • the content described in FIG. 4 is merely an example, and is not limited to the content shown in the figure.
  • the shape and size of the conductive gel layer 132 are not limited to the contents shown in the drawings, and can be arbitrarily changed. According to the change in the shape and size of the conductive gel layer 132, the shape and size of the holes (or grooves) in the waterproof layer 131, the waterproof layer 133, the water absorption layer 134, and the skin adhesive layer 135 are also changed.
  • the holes (or grooves) in the waterproof layer 131, the waterproof layer 133, the water absorption layer 134, and the skin adhesive layer 135 are examples of openings.
  • the adhesive portion 130 may have an adhesive layer for adhering each layer in addition to the above five layers.
  • the adhesive layer can be formed of any adhesive such as a liquid or a sheet.
  • the adhesive layer can be omitted.
  • the adhesive layer can be omitted between the water-absorbing layer 134 and the skin-adhesive layer 135.
  • the waterproof layer 133 has an adhesive function with the water absorbing layer 134
  • the adhesive layer can be omitted between the waterproof layer 133 and the water absorbing layer 134.
  • each part described in FIG. 4 are not limited to the above-mentioned materials.
  • known materials can be arbitrarily applied as long as the functions of the above-mentioned parts are not impaired.
  • FIG. 5 is a diagram for explaining a method of attaching the wearable device 100 according to the embodiment.
  • the wearable device 100 is distributed in a state where the flexible substrate 110, the electronic component portion 120, and the adhesive portion 130 are integrated. That is, as shown in FIG. 5, the flexible substrate 110 and the electronic component portion 120 are previously adhered to the upper surface of the adhesive portion 130.
  • the upper surface of the adhesive portion 130 corresponds to the upper surface of the waterproof layer 131, and corresponds to the surface of the waterproof layer 131 opposite to the surface adjacent to the conductive gel layer 132.
  • the bottom surface of the wearable device 100 (that is, the bottom surface of the skin adhesive layer 135) is covered with a release paper.
  • the user of the wearable device 100 peels off the release paper to expose the bottom surface of the skin adhesive layer 135. Then, the user attaches the bottom surface of the skin adhesive layer 135 to an arbitrary position on the skin of the subject.
  • the bottom surface of the adhesive portion 130 corresponds to the bottom surface of the skin adhesive layer 135, and corresponds to the surface of the skin adhesive layer 135 opposite to the surface adjacent to the water absorption layer 134.
  • the user of the wearable device 100 corresponds to a medical worker such as a doctor, a target person, a person who supports the target person in terms of medical treatment or life, and the like.
  • the skin adhesive layer 135, the water absorbing layer 134, the waterproof layer 133, the conductive gel layer 132, the waterproof layer 131, and the electrode layers (electrodes 111, 112, 113) are arranged in this order from the side closest to the human body (skin). It is a layer structure having a flexible layer (flexible substrate 110), an isolation layer (hard substrate 121), and an electronic component layer (electronic component section 120). Then, the electrode portions (electrodes 111, 112, 113) of the wearable device 100 attached to an arbitrary position on the skin detect biological information from the human body via the conductive gel portion (132).
  • each part included in the wearable device 100 may be manufactured and distributed by an individual vendor.
  • each layer has the same thickness, but the thickness of each layer can be set arbitrarily.
  • the thickness of the skin adhesive layer 135, the water absorption layer 134, and the waterproof layer 133 is extremely thin as compared with the hole sizes (diameters) of the skin adhesive layer 135, the water absorption layer 134, and the waterproof layer 133, the wearable device.
  • the conductive gel layer 132 is easily in contact with the skin of the subject.
  • the layer having the three electrodes 111, 112, 113 is described as an “electrode layer”, but each electrode 111, 112, 113 is smaller than the flexible layer and the isolation layer, and is a point. Since it exists in a shape, it does not necessarily have to be called a "layer”.
  • the three electrodes 111, 112, 113 may be referred to as “electrode portions”.
  • the layer having the three conductive gels 132A, 132B, 132C is described as “conductive gel layer”, but each conductive gel 132A, 132B, 132C is compared with the flexible layer and the isolation layer. Since it is small and exists in dots, it does not necessarily have to be called a "layer".
  • the three conductive gels 132A, 132B, 132C may be referred to as "conductive gel portions”.
  • the wearable device 100 includes a detection unit (electrode layer and conductive gel layer 132), a flexible layer (flexible substrate 110), an isolation layer (hard substrate 121), and an electronic component layer (electronic component section 120). ) And.
  • the detection unit detects biological information.
  • the flexible layer has a conductor that is electrically connected to the detector.
  • the isolation layer is laminated on the flexible layer and is harder than the flexible layer.
  • the electronic component layer includes electronic components that are laminated on the isolation layer and electrically connected to the conductor. According to this, the wearable device 100 can stably acquire continuous biometric information.
  • the wearable device 100 since the wearable device 100 has an isolation layer for isolating the electronic component layer from the deflection of the flexible layer, the risk of damage to the electronic component layer due to the deflection is reduced, so that continuous biometric information can be stably acquired. It becomes possible.
  • the wearable device 100 includes a detection unit, a first layer, a second layer, and a third layer.
  • the detection unit detects biological information.
  • the first layer is arranged in the first direction of the detector, has a conductor electrically connected to the detector, and is flexible.
  • the second layer is arranged in the first direction of the first layer and is harder than the first layer.
  • the third layer contains electronic components that are arranged in the first direction of the second layer and are electrically connected to the conductor.
  • the wearable device 100 includes a fourth layer and a fifth layer.
  • the fourth layer is arranged in a second direction opposite to the first direction of the detection unit and is waterproof.
  • the fifth layer is arranged in the second direction of the fourth layer and has water absorption.
  • the wearable device 100 includes a conductive gel layer 132, an electrode layer (electrodes 111, 112, 113), an electronic component layer (electronic component section 120), a flexible layer (flexible substrate 110), and a waterproof layer 133. It is provided with a water absorption layer 134.
  • the conductive gel layer 132 is in contact with the skin of the subject.
  • the electrode layer has an electrode that is electrically connected to the conductive gel layer 132.
  • the electronic component layer includes electronic components.
  • the flexible layer has a conductor in which an electrode layer is arranged on a first surface, an electronic component layer is arranged on a second surface opposite to the first surface, and the electrode layer and the electronic component layer are electrically connected.
  • the waterproof layer 133 is arranged on the surface of the conductive gel layer 132 opposite to the surface adjacent to the electrode layer.
  • the water absorption layer 134 is arranged on the surface of the waterproof layer 133 opposite to the surface adjacent to the conductive gel layer 132. According to this, the wearable device 100 can stably acquire continuous biometric information. For example, since the wearable device 100 has a water absorption layer 134 that absorbs sweat and dissipates it to the outside of the wearable device 100, the hydrogel (conductive gel layer 132) absorbs moisture, expands, and peels off from the adjacent layer. Reduce the possibility. As a result, the wearable device 100 can stably acquire continuous biometric information.
  • the wearable device 100 includes a first layer, a second layer, a conductive gel portion, an electrode portion, a third layer, and a fourth layer.
  • the first layer has water absorption.
  • the second layer is arranged in the first direction of the first layer and is waterproof.
  • the conductive gel portion is arranged in the first direction of the second layer and can come into contact with the skin of the subject.
  • the electrode portion is arranged in the first direction of the conductive gel portion and is electrically connected to the conductive gel portion.
  • the third layer is arranged in the first direction of the electrode portion, has a conductor electrically connected to the electrode portion, and has flexibility.
  • the fourth layer contains electronic components that are arranged in the first direction of the third layer and are electrically connected by conductors. It should be noted that the above description of "1st" to "4th” is used to distinguish each layer, and does not mean an order or the like.
  • FIG. 6 is a diagram showing an example of the structure of the adhesive portion 130 according to the modified example.
  • the upper part of FIG. 4 illustrates a front view of the adhesive portion 130.
  • the bottom view of the adhesive portion 130 is illustrated in the lower part of FIG.
  • the hole of the water absorption layer 134 has a diameter of 15 mm and is the same size as the hole of the waterproof layer 133.
  • the end (edge) of the hole of the water absorption layer 134 and the conductive gels 132A, 132B, 132C are close to each other, the water absorbed by the water absorption layer 134 passes through the end of the hole and the conductive gels 132A, 132B, respectively. , 132C may be absorbed.
  • the waterproof layer 133 has a thickness of 30 ⁇ m or more and less than 150 ⁇ m, and more preferably 75 ⁇ m or more and less than 120 ⁇ m.
  • the ends (edges) of the holes of the water absorption layer 134 and the conductive gels 132A, 132B, 132C are separated from each other, so that they are absorbed by the water absorption layer 134. It is possible to reduce the possibility that the water is absorbed by the conductive gels 132A, 132B, 132C through the end of the hole.
  • the wearable device 100 can easily follow the movement of the wearer, so that it becomes possible to acquire biometric information more stably.
  • the hole of the skin adhesive layer 135 has a diameter of 15 mm, which is the same size as the hole of the waterproof layer 133 and the hole of the water absorption layer 134.
  • the holes can be formed after the waterproof layer 133, the water absorption layer 134, and the skin adhesive layer 135 are superimposed, so that the manufacturing process can be simplified.
  • the present embodiment can be provided as a detection method including detecting an abnormality (heart disease such as atrial fibrillation) of a subject based on biological information acquired by using the wearable device 100.
  • the detection method detects an abnormality of the subject based on biometric information for 72 hours or more.
  • a detection time can detect an abnormality of the subject with higher accuracy if it is a long time, and is preferably based on a detection time of 120 hours or more, more preferably 168 hours or more. Therefore, it is preferable to detect the abnormality of the subject.
  • a known method can be arbitrarily applied.
  • the device configurations to be changed are four items: layer configuration, isolation layer area, isolation layer material, and isolation layer position.
  • the layer structure is the layer structure described in the above-described embodiment. That is, the layer configurations shown in Table 1 are, in order from the side closer to the human body (skin), the skin adhesive layer 135, the water absorption layer 134, the waterproof layer 133, the conductive gel layer 132, the waterproof layer 131, and the electrode layers (electrodes 111, 112, 113), shows whether or not each layer has a flexible layer (flexible substrate 110), an isolation layer (hard substrate 121), and an electronic component layer (electronic component section 120).
  • the “ ⁇ ” mark indicates that the layer is possessed
  • the “-” mark indicates that the layer is not possessed.
  • each layer As a detailed structure (material) of each layer, a layer containing an acrylic adhesive and a hydrocolloid was used as the skin adhesive layer 135, and a non-woven fabric made of polyurethane resin was used as the water absorption layer 134, and the waterproof layer 133 and the waterproof layer 131 were formed. Used a layer made of polyester resin, and a substrate made of polyimide resin having a thickness of 0.18 mm was used for the flexible substrate 110. Further, in the electrode layer, as in FIGS. 2 and 5, electrodes 111 and 112 are arranged at both ends in the longitudinal direction of the wearable device, and the electrode 113 is placed between the two electrodes at a position close to the electrode 112. Placed.
  • the electrode 111 and the electrode 112 were used as a positive electrode and a negative electrode, and the electrode 113 was used as a reference electrode.
  • the material of the isolation layer is described later in "Separation layer material" in Table 1, and each has a thickness of 0.8 mm.
  • the isolated layer area indicates the ratio [%] of the isolated layer area to the flexible layer area.
  • the "-" mark indicates that there is no corresponding data (there is no isolation layer).
  • the isolation layer material indicates the material of the isolation layer.
  • one of glass epoxy, paper phenol, and glass polyimide was selected as the isolation layer material.
  • the "-" mark indicates that there is no corresponding data (there is no isolation layer).
  • the isolation layer position indicates the position of the isolation layer in the flexible layer.
  • the isolation layer position was selected at the end or the center.
  • the end portion is one of both ends in the longitudinal direction of the wearable device, and is a position corresponding to the electrode 111 or the electrode 112.
  • the center is between the electrode 111 and the electrode 112, and is a position not corresponding to the electrode 113.
  • the "-" mark indicates that there is no corresponding data (there is no isolation layer).
  • the wearable device of the first embodiment has a skin adhesive layer 135, a water absorption layer 134, a waterproof layer 133, a conductive gel layer 132, a waterproof layer 131, an electrode layer, a flexible layer, an isolation layer, and an electronic component layer. It has 9 layers of. Further, in the wearable device of the first embodiment, the isolation layer area is "35%”, the isolation layer material is "glass epoxy”, and the isolation layer position is "end”.
  • the wearable device of Example 2 has an isolated layer area of "15%". Further, the layer structure, the isolation layer material, and the isolation layer position of the wearable device of the second embodiment are the same as the layer composition, the isolation layer material, and the isolation layer position of the first embodiment.
  • the wearable device of Example 3 has an isolated layer area of "45%". Further, the layer structure, the isolation layer material, and the isolation layer position of the wearable device of the third embodiment are the same as the layer composition, the isolation layer material, and the isolation layer position of the first embodiment.
  • the material of the isolation layer is "paper phenol".
  • the layer structure, the isolated layer area, and the isolated layer position of the wearable device of the fourth embodiment are the same as the layer structure, the isolated layer area, and the isolated layer position of the first embodiment.
  • the isolation layer material is "glass polyimide”. Further, the layer structure, the isolated layer area, and the isolated layer position of the wearable device of the fifth embodiment are the same as the layer structure, the isolated layer area, and the isolated layer position of the first embodiment.
  • the isolation layer position is "center”. Further, the layer structure, the isolated layer area, and the isolated layer material of the wearable device of the sixth embodiment are the same as the layer structure, the isolated layer area, and the isolated layer material of the first embodiment.
  • the wearable device of the seventh embodiment does not have a water absorbing layer 134 in the layer structure, and has a skin adhesive layer 135, a waterproof layer 133, a conductive gel layer 132, a waterproof layer 131, an electrode layer, a flexible layer, an isolation layer, and an electronic component layer. Has 8 layers of. Further, the isolated layer area, the isolated layer material, and the isolated layer position of the wearable device of the seventh embodiment are the same as the isolated layer area, the isolated layer material, and the isolated layer position of the first embodiment.
  • the wearable device of Comparative Example 1 does not have the water absorption layer 134 and the isolation layer in the layer structure, and has a skin adhesive layer 135, a waterproof layer 133, a conductive gel layer 132, a waterproof layer 131, an electrode layer, a flexible layer, and an electronic component layer. It has 7 layers of. Further, since the wearable device of Comparative Example 1 does not have the isolation layer, there is no corresponding data of the isolation layer area, the isolation layer material, and the isolation layer position.
  • the wearable device of Comparative Example 2 does not have the water absorption layer 134, the waterproof layer 133, and the isolation layer in the layer structure, and has a skin adhesive layer 135, a conductive gel layer 132, a waterproof layer 131, an electrode layer, a flexible layer, and an electronic component. It has 6 layers. Further, since the wearable device of Comparative Example 2 does not have the isolation layer, there is no corresponding data of the isolation layer area, the isolation layer material, and the isolation layer position.
  • the evaluation of the wearable device according to each example and the comparative example will be described.
  • the evaluation of the wearable device according to each Example and Comparative Example was performed for five items of bending test 1, bending test 2, data accuracy, waterproofness, and discomfort.
  • Bending test 1 is a test in which each wearable device is bent and stretched 100 times using a test device for bending test.
  • this test device is a device capable of automatically repeating bending and stretching of a plate-shaped test object.
  • the test apparatus includes two plate members having variable relative angles as pedestals, and by fixing both ends of the test object to the two plate members, the test object is bent and stretched.
  • both ends 15 mm of the wearable device were fixed to the pedestal with tape, and bending and stretching with a bending radius of 17 mm and a bending angle of 180 ° were repeated.
  • each wearable device was used to evaluate the damage situation. The damage status was evaluated on a three-point scale of "A", "B", and "C". "A” indicates that it can be used as before the test, that is, no damage is observed.
  • “B” indicates that the wearable device was operated, but some loss was found in the acquired data.
  • “C” indicates that the wearable device has stopped working.
  • the bending test 2 is a test in which the bending and stretching of each wearable device is performed 1000 times using the test device used in the bending test 1. After 1000 bends and stretches, each wearable device was used to evaluate the damage situation. Since the evaluation criteria for the damage condition are the same as those in the bending test 1, the description thereof will be omitted.
  • the accuracy of the data (electrocardiographic signal) acquired by using each wearable device for 7 days was evaluated based on the data loss and the low noise.
  • Data accuracy was evaluated on a three-point scale of "A", "B", and "C". "A” indicates that no data loss or noise is observed. "B” indicates that a part of the data was damaged or noisy. “C” indicates that the wearable device was damaged and data for 7 days could not be obtained.
  • the waterproof property was evaluated based on the expansion rate of the conductive gel layer 132 after each wearable device was left for 7 days in an environment of a temperature of 30 degrees and a humidity of 95%.
  • the coefficient of expansion was evaluated on a two-point scale of "A" and "B". "A” indicates that the coefficient of expansion is less than 20%. “B” indicates that the expansion coefficient is 20% or more.
  • Discomfort is an evaluation of the discomfort of the wearer when each wearable device is worn for 7 days. Discomfort was evaluated on a three-point scale of "A", "B", and “C". "A” indicates that he did not feel particularly uncomfortable. “B” indicates that some itchiness was felt. “C” indicates that the patient felt a strong itch. Itching that occurred in the evaluation of discomfort was generally observed 72 hours after wearing. In addition, strong itchiness was observed approximately 120 hours after wearing.
  • the evaluation result of "A" was obtained in 5 items of bending test 1, bending test 2, data accuracy, waterproofness, and discomfort.
  • the wearable device of Example 1 gave the best results as compared with the wearable devices of other examples and comparative examples.
  • the evaluation result of "B” was obtained in terms of data accuracy and discomfort. From this result, it was suggested that by making the isolation layer harder than a certain level (glass polyimide), the shape of the wearable device can easily follow the movement of the body and can prevent peeling.
  • the evaluation result of "B" was obtained in the bending test 2, the data accuracy, and the discomfort.
  • the isolation layer when the isolation layer is in the central portion, the flexible layer bends at both ends of the isolation layer, so that there are two bending points as compared with the case where the isolation layer is at the end (one bending point). Increase to. From this result, it was suggested that the risk of disconnection can be reduced by reducing the bending point. In addition, it was suggested that by reducing the bending point, it becomes easier to follow the movement of the body and it is possible to prevent peeling.
  • Wearable device 110 Flexible board 111, 112, 113 Electrode 120 Electronic component part 121 Hard board 130 Adhesive part 131, 133 Waterproof layer 132 Conductive gel layer 134 Water absorption layer 135 Skin adhesive layer 140 Lead wire

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