WO2016143666A1 - 生体用電極具 - Google Patents
生体用電極具 Download PDFInfo
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- WO2016143666A1 WO2016143666A1 PCT/JP2016/056622 JP2016056622W WO2016143666A1 WO 2016143666 A1 WO2016143666 A1 WO 2016143666A1 JP 2016056622 W JP2016056622 W JP 2016056622W WO 2016143666 A1 WO2016143666 A1 WO 2016143666A1
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- electrode
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- nonwoven fabric
- living body
- layer
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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
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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
- A61B5/251—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
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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
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
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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
- A61B5/68—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
Definitions
- the present invention relates to a biological electrode device for obtaining a biological signal such as a vital sensor for obtaining an electrocardiogram or the like.
- Bioelectricity generated by a living body such as a human is induced by activities of the heart, brain, muscle, and the like, and a weak voltage generated by the induced bioelectricity is acquired by a biological electrode tool that is in close contact with the skin of the living body.
- the acquisition may be temporary such as an electrocardiogram at the time of a health check, or may be a long time for health management such as during surgery or health care, and the state of the heart or the like is diagnosed based on the acquired data.
- the biological electrode device generally has an electrode part that is attached to a living body to acquire a biological signal, and a lead part that leads the biological signal to the outside from the electrode part (Patent Document 1, below). 2).
- the bioelectrode device in which the front and back surfaces of the electrode part and the lead part are covered with a nonwoven fabric is manufactured by forming a plurality of bioelectrode part and lead part patterns on a film and punching out each of the bioelectrode part and the lead part.
- a nonwoven fabric is manufactured by forming a plurality of bioelectrode part and lead part patterns on a film and punching out each of the bioelectrode part and the lead part.
- the first problem is to eliminate the exposure of the conductive portion
- the second problem is to eliminate the influence of external noise
- the present invention is such that the non-woven fabric on the front and back surfaces of the electrode part and the lead part is joined around the entire circumference except for the part in contact with the living body and the lead-out end part to the outside. It is. With this configuration, the electrode of the electrode part and the thin film lead wire of the lead part are not exposed. For this reason, the exposed conductive portion does not touch the skin or the like and the detection signal becomes unstable and an error does not occur, and a living body such as a person does not feel uncomfortable.
- a shield layer is provided around the lead wire through an insulating layer on the entire peripheral surface of the lead portion to shield external noise. .
- the shield layer can also be provided on the electrode portion. In this case, it is a matter of course that the portion in contact with the living body is excluded.
- the electrode has an electrode part that is attached to a living body to acquire a biological signal, and a lead part that leads the biological signal to the outside from the electrode part.
- the entire area of the front and back surfaces of the electrode is covered with a non-woven fabric provided with an electrode opening on the side in contact with the living body and the non-woven fabric facing the non-woven fabric. It is covered with a nonwoven fabric, and the nonwoven fabric on the front and back surfaces of the electrode part and the lead part is joined via an adhesive layer at joints provided around the entire circumference except for the electrode opening part and the lead-out end part to the outside. Can be adopted.
- a shield layer covering the entire circumference of the lead wire through an insulating layer is provided over the entire length of the lead portion, and the nonwoven fabric is covered with the nonwoven fabric, and the nonwoven fabric is bonded at the joint portion. If it is made to join through a layer, the shield layer will also not be exposed from the nonwoven fabric of front and back, and the said 2nd subject can be achieved.
- the biological signal obtained at the electrode part can be sent to the measuring instrument side while suppressing external noise as much as possible, so the S / N is increased and no means for increasing the S / N is required. Thus, the cost of the entire apparatus can be reduced.
- the shield layer since the shield layer is not exposed, there is no discomfort caused by touching the living body.
- an adhesive resin is coated on the nonwoven fabric in contact with the living body, the lead portion can be brought into close contact with the living body.
- the thin film lead wire is a sheet (or film) -like substrate made of a metal foil such as Cu (copper), Au (gold), Ag (silver), Al (aluminum), Ni (nickel), or a vapor deposited film thereof. Can be formed and created.
- a conductive ink, a conductive paste, or a conductive adhesive in which a conductive polymer or a conductive filler is dispersed in a binder can be formed on a sheet-like substrate.
- the conductive polymer polyacetylene, polypyrrole, polythiophene, polyaniline, or the like can be used.
- the conductive filler metal powder having conductivity such as Cu powder, Ag powder, Au powder, Al powder, and Ni powder can be used. Also, a conductive filler obtained by plating or coating a conductive material on the core material such as the metal powder or resin powder can be used. Carbon powder, conductive polymer powder, or the like can also be used as the conductive filler.
- the thickness and width of the thin film lead are arbitrary as long as they exhibit their functions. For example, the thickness is 1 to 100 ⁇ m and the width is 100 to 5000 ⁇ m.
- a material that can be thinly formed using a conductive material such as an ultrafine copper wire (high strength wire) having a diameter of 20 to 100 ⁇ m, a carbon nanotube, or a metal-plated resin fiber, or a material that can be thinly formed. Etc. can be applied as appropriate, and these are also included in the thin film lead wire.
- a conductive material such as an ultrafine copper wire (high strength wire) having a diameter of 20 to 100 ⁇ m, a carbon nanotube, or a metal-plated resin fiber, or a material that can be thinly formed. Etc. can be applied as appropriate, and these are also included in the thin film lead wire.
- any nonwoven fabric may be used as long as it is not imparted with electrical conductivity.
- polyester resin fibers are used.
- the thickness may be any thickness as long as it does not interfere with use, and is set to, for example, 50 to 3000 ⁇ m.
- the adhesive for joining the front and back nonwoven fabrics preferably has high adhesiveness to the intervening conductive material (electrode, lead wire), and more preferably has electrical insulation, waterproofness or both.
- PE polyethylene
- the shield layer can be formed by the same material and method as the thin film lead wire, and the thickness thereof is arbitrary as long as the shield effect can be obtained, but it is, for example, 0.1 to 1000 ⁇ m.
- the present invention is configured as described above, it can be used as a bioelectrode tool that has a good touch and high detection accuracy.
- FIGS. 1 to 4C An embodiment of a bioelectrode device according to the present invention is shown in FIGS. 1 to 4C, and this bioelectrode device A1 is affixed to a living body such as a human body and obtains a biosignal as in the prior art. And a lead part 20 for leading the biological signal from the electrode part 10 to the outside.
- the electrode portion 10 is covered with the nonwoven fabric 30 in the entire front and back surfaces except for the portion (electrode opening portion) in contact with the living body, and the lead portion 20 is also covered with the nonwoven fabric 30 in the entire front and back surfaces except for the lead-out end portion to the outside.
- the non-woven fabric 30 on the front and back surfaces of the electrode part 10 and the lead part 20 is joined around the entire circumference except for the part in contact with the living body and the lead-out end part to the outside.
- the electrode unit 10 is an electrode 11 in which an Ag paste layer 11 a and a silver chloride (AgCl) paste layer 11 b are sequentially provided on a nonwoven fabric 30.
- the lead portion 20 is a non-woven fabric 30 provided with a copper foil electric wire 21, and the copper foil electric wire (lead wire) 21 is, for example, on a wide polyethylene terephthalate (PET) film 21 a (for example, 12 ⁇ m thick).
- PET polyethylene terephthalate
- a copper foil 21b (for example, 6 ⁇ m thick) is pasted on and cut into a width of 1 mm (see FIG. 4A).
- the front and back nonwoven fabrics 30 (hereinafter, in FIGS.
- the lower side (back side) nonwoven fabric is 30a and the upper side (front side) nonwoven fabric is 30b).
- a PE-coated adhesive layer 31 (for example, 20 ⁇ m thick) is formed.
- the adhesive layer 31 ensures insulation and waterproofness. For this reason, even if sweat or various liquids adhere to the nonwoven fabric 30, there is no harm to the living body, and the influence on the detection accuracy is extremely small.
- the bioelectrode A1 having this structure is manufactured by sequentially providing an AgCl paste layer 11b and an Ag paste layer 11a of a predetermined size on a PET film 12, respectively.
- the copper foil electric wire 21 is placed with the PET film 21a facing the nonwoven fabric 30a on the nonwoven fabric 30a on which the adhesive layer 31 is formed, and the Ag paste layer 11a and the AgCl paste layer 11b are further formed thereon.
- the electrode 11 composed of the Ag paste layer 11a and the AgCl paste layer 11b is interposed on the non-woven fabric 30a via the adhesive layer 31, as shown in FIGS. 4B and 4C. Transfer by thermal transfer method or the like.
- the Ag paste layer 11a is obtained by mixing an Ag filler in the adhesive resin.
- a non-woven fabric 30b provided with a hole (a part in contact with the living body: electrode opening) 13 having the size of the electrode 11 is placed on the lower non-woven fabric 30a with an adhesive layer 31 so that the electrode 11 is positioned in the hole 13.
- Thermal fusion thermal bonding
- the non-woven fabric 30 (30a, 30b) on the front and back surfaces of the electrode part 10 and the lead part 20 is excluding the part in contact with the living body (hole 13 part) and the lead-out end part (terminal part 14) to the outside.
- the periphery of the non-woven fabrics 30a and 30b set wider than the diameter of the circular electrode 11 or the width of the electric wire 21 is used as a joint, and the entire circumference is joined via the adhesive layer 31 of the joint (FIG. 2A, Thereby, the electrode 11 of the electrode part 10 and the electric wire 21 of the lead part 20 are not exposed by this. For this reason, except the part which contact
- the electrode unit 10 is attached to a required position of the human body via a conductive gel, and an inspection device (measuring instrument) such as an electrocardiograph is connected to the terminal unit 14. To obtain an electrocardiogram.
- FIGS. 6 and 7 show a biological electrode device A2 according to another embodiment.
- This biological electrode device A2 is produced by separately manufacturing the electrode portion 10 and the lead portion 20, and includes the electrode 11, the electric wire 21 and the like.
- the configuration is the same as in the above embodiment.
- the electrode part 10 and the lead part 20 are connected to the lead part 20 with the Ag paste before the upper nonwoven part 30 b of the electrode part 10 is joined to the lower nonwoven part 30 a. It puts on the drawer
- the electrode part 10 is affixed to a required position of the human body via a conductive gel, and an electrocardiograph or the like is connected to the terminal part 14 so that an electrocardiogram or the like is obtained. obtain.
- the bioelectrode tool A3 has an entire circumference excluding the holes 13 of the electrode part 10 and the entire length of the lead part 20.
- the shield layer 40 covering the electrode 11 and the electric wire 21 is provided over the entire area, and the entire area of the shield layer 40 is covered with the nonwoven fabrics 30a and 30b on the front and back surfaces. Since it is joined via 31, the side edges of the shield layer 40 are not exposed.
- the shield layer 40 is made of metal foil such as Cu, Au, Ag, Al, Ni or the like, or a vapor-deposited film thereof, like the above-described electric wire 21, by coating, foil sticking, or the like on the opposing surfaces of the nonwoven fabrics 30a, 30b.
- a conductive layer 41 is provided by a conductive ink, a conductive paste, a conductive adhesive, or the like in which a conductive resin or a conductive filler is dispersed in a binder, and both the conductive layers 41 are insulated by an insulating adhesive 31 such as PE. It is formed by bonding through the layer 42.
- the insulating layer 42 is provided at least in a range where the conductive layer 41, the electric wire 21 and the electrode 11 may come into contact with each other (as shown in FIG. 9A, the insulating layer 42 may not be on the entire area of the facing surfaces of the nonwoven fabrics 30a and 30b).
- the electrode portion 10 is attached to a required position of the living body via a conductive gel, and an electrocardiograph or the like is connected to the terminal portion 14 to perform an electrocardiogram or the like. obtain.
- an electrocardiograph or the like is connected to the terminal portion 14 to perform an electrocardiogram or the like.
- the lead wire (electric wire) 21 and the shield layer 40 can be formed by directly applying a conductive paste or the like to the nonwoven fabric 30.
- the bioelectrode tools A1 to A3 can be provided in which conductive gel is provided on the AgCl layer 11b. In this case, a film covering the conductive gel can be provided, and the film can be peeled off during use.
- the living body side of the nonwoven fabric 30a of the lead portion 20 is coated with an adhesive resin such as urethane resin or acrylic resin, the lead portion 20 can be brought into close contact with the living body, and the biological electrode devices A1 to A3 can be used all day long. When it is worn for a long time, it is easy to handle.
- Electrode part 11 Electrode 11a Ag paste layer 11b AgCl paste layer 12 PET film 13
- Lead part 21 Lead wire (electric wire) 30
- Nonwoven Fabric 30a Nonwoven Fabric 30b on Lower (Back) Side Nonwoven Fabric 31 on Upper (Front) Side Adhesive Layer 40
- Shield Layer 41 Metal Layer 42 Forming Shield Layer Insulating Layer
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Abstract
Description
その生体電極具は、一般的に、生体に貼り付けられて生体信号を取得する電極部と、前記生体信号を前記電極部から外部に導出するリード部を有する構成である(下記特許文献1、2参照)。
このため、電極部及びリード部の打ち抜き端面には、導電電極や導電リード線が露出しており、この露出導電部分が皮膚等に触れると、検出信号が不安定になって誤差が生じるとともに、生体(人)に不快感を与える。
また、リード部は、1m以上にもなる場合があり、外部ノイズの影響を受ける恐れがある。外部ノイズの影響を受ければ、検出精度に誤差が生じる。
また、第2の課題を達成するため、この発明は、リード部の全周面にシールド層をリード線の周りに絶縁層を介して設けて、外部からのノイズを遮蔽することとしたのである。シールド層は電極部にも設けることができる。この場合、生体に接する部分は除くことは勿論である。
このシールド層によって、電極部で得られた生体信号を外部ノイズの混入を極力抑えて測定器側に送ることができるため、S/Nが上がり、そのS/Nの上昇のための手段も不要となり、装置全体のコストを下げることができる。また、シールド層も露出しないため、触れることによる不快感を生体に与えることもない。
さらに、生体に接する側の不織布に粘着性樹脂をコーティングすれば、リード部を生体に密着させることができる。
上記薄膜状リード線の厚みや幅は、機能を発揮する限りにおいて任意であり、例えば、厚みは1~100μm、幅は100~5000μmとする。また、例えば、径:20~100μmの極細銅線(高力線)や、カーボンナノチューブ、金属メッキをした樹脂繊維など、導電性材料を用いて薄く成形することができる材料や、細く成形できる材料などが適宜に適用することができ、それらも薄膜状リード線に含まれるものとする。
上記表裏の不織布を接合する接着材は、介在する導電材(電極、リード線)への接着性の高いものが好ましく、さらに、電気絶縁性、防水性又はその両者を有するものが好ましい。例えば、ポリエチレン(PE)を使用する。
シールド層は、上記薄膜状リード線と同様の材料及び方法で形成することができ、その厚みもシールド効果を得ることができる限りにおいて任意であるが、例えば、0.1~1000μmとする。
上記リード部20は、不織布30上に銅箔電線21を設けたものであり、その銅箔電線(リード線)21は、例えば、幅広のポリエチレンテレフタレート(PET)フィルム21a(例えば、12μm厚)上に銅箔21b(例えば、6μm厚)を貼付し、1mm幅に切断したものである(図4A参照)。
表裏の不織布30(以下、図4B、図4Cにおいて、下側(裏側)の不織布を30a、上側(表側)の不織布を30bとする。)は、その対向面に接着材としてのPEフィルム貼付やPEコーティングされた接着層31(例えば、20μm厚)が形成されている。この接着層31によって絶縁性と防水性が担保される。このため、汗や各種の液が不織布30に付着しても、生体に害はなく、また、検出精度に対する影響が極めて少ないものとなる。
このとき、不織布30(両不織布30a、30b)は、図1実線に示す形状に切断されたものであっても、鎖線で示す長尺状の両不織布30a、30bを接合した後、実線で示す形状に切り抜いた物であっても良い。何れにしても、電極部10とリード部20の表裏面の不織布30(30a、30b)は前記生体に接する部分(孔13部分)及び外部への導出端部分(端子部14)を除いて、円形電極11の径又は電線21の幅よりも広く設定された不織布30a、30bの周囲を接合部とし、その接合部の接着層31を介してその全周周囲が接合しており(図2A、図2B参照)、これにより、電極部10の電極11とリード部20の電線21は露出していない。このため、生体に接する部分を除いて、導電部分である電極11及び電線21が皮膚に触れることはない。
この実施形態の生体電極具A2も、従来と同様に、人体の所要位置に導電ジェルを介して電極部10を貼付し、端子部14に心電計などの検査器を接続して心電図等を得る。
シールド層40は、リード部20のみに設けることができる(電極部10には設けないものとすることができる)。
さらに、リード部20の不織布30aの生体側にウレタン樹脂、アクリル樹脂等の粘着性樹脂をコーティングすれば、リード部20を生体に密着させることができて、この生体電極具A1~A3を一日中等の長時間装着する場合に取り扱い性の良いものとなる。生体には、人体のみならず、犬や猫等の動物も含まれることは勿論である。
このように、今回開示された実施の形態はすべての点で例示であって制限的なものではないと考えられるべきである。この発明の範囲は、特許請求の範囲によって示され、特許請求の範囲と均等の意味および範囲内でのすべての変更が含まれることが意図される。
11 電極
11a Agペースト層
11b AgClペースト層
12 PETフィルム
13 生体に触れる部分の孔(生体に接する部分)
14 端子部(外部への導出部分)
20 リード部
21 リード線(電線)
30 不織布
30a 下(裏)側の不織布
30b 上(表)側の不織布
31 接着層
40 シールド層
41 シールド層をなす金属層
42 絶縁層
Claims (4)
- 生体に貼り付けられて生体信号を取得する電極部(10)と、前記生体信号を前記電極部(10)から外部に導出するリード部(20)を有し、
上記電極部(10)は、生体に接する側の電極開口部(13)を設けた不織布(30b)及びその不織布(30b)に対向する不織布(30a)により電極(11)の表裏面全域が被覆されており、上記リード部(20)も、外部への導出端部分(14)を除いて表裏面全域が不織布(30a、30b)で被覆されており、前記電極部(10)とリード部(20)の表裏面の不織布(30a、30b)は前記電極開口部(13)及び外部への導出端部分(14)を除いてその全周周囲に設けた接合部で接着層(31)を介して接合されていることを特徴とする生体用電極具。 - 上記接着層(31)が、電気絶縁性、防水性又はその両者を有するものであることを特徴とする請求項1に記載の生体用電極具。
- 上記リード部(20)の全長に亘ってそのリード線(21)全周を絶縁層(42)を介して被うシールド層(40)を設け、そのシールド層(40)の全域を上記不織布(30a、30b)が被って、その不織布(30a、30b)は上記接合部で接着層(31)を介して接合されていることを特徴とする請求項1又は2に記載の生体用電極具。
- 上記生体に接する側の不織布(30a)に粘着性樹脂をコーティングしたことを特徴とする請求項1乃至3の何れかに記載の生体用電極具。
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US15/557,002 US10835140B2 (en) | 2015-03-12 | 2016-03-03 | Biological electrode tool |
CN201680012887.3A CN107405097B (zh) | 2015-03-12 | 2016-03-03 | 生物体用电极装置 |
JP2017505282A JP6695321B2 (ja) | 2015-03-12 | 2016-03-03 | 生体用電極具 |
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JP2015049026 | 2015-03-12 | ||
JP2015-049026 | 2015-03-12 |
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JP (1) | JP6695321B2 (ja) |
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JP2016182755A (ja) * | 2015-03-26 | 2016-10-20 | 住江織物株式会社 | 布帛電極及びその製造方法 |
JP2017218690A (ja) * | 2016-06-07 | 2017-12-14 | 住江織物株式会社 | 布帛電極 |
CN112263255A (zh) * | 2020-09-28 | 2021-01-26 | 北京师范大学 | 一种基于导电聚合物转移的石墨烯皮肤电极及其制备方法 |
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CN107405097A (zh) | 2017-11-28 |
JP6695321B2 (ja) | 2020-05-20 |
US20180055399A1 (en) | 2018-03-01 |
US10835140B2 (en) | 2020-11-17 |
JPWO2016143666A1 (ja) | 2017-12-28 |
CN107405097B (zh) | 2021-02-02 |
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