JP3320306B2 - Method for manufacturing multipolar bioelectrode - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method of manufacturing a multi-polar bioelectrode to be applied to a skin surface of a living body to perform measurement or treatment when performing electrocardiogram measurement, electrical stimulation treatment, or the like. <br/>

[0002]

2. Description of the Related Art In order to measure electrocardiograms, myoelectrics, electroencephalograms, and the like,
Detects weak electric potential emitted from the human body. On the other hand, when performing electrical stimulation treatment or the like, an electric current is applied to an appropriate part of the human body.
In each case, conventionally, a plurality of electrodes have been pasted one by one at an appropriate position on a human body. However, it is difficult to affix the electrode at the correct position. Therefore, a fixing jig made of metal or resin for fixing a plurality of electrodes has been developed. The fixing jig is attached to a human body so that the electrodes can be stuck to accurate positions of the human body. However, such a jig as described above has a drawback that it is bulky and takes up space, so that it is difficult to store and store it, transport is inefficient, and the number of parts is large and the cost is high.

[0003]

Problems to be Solved by the Invention
Japanese Patent Application Laid-Open Publication No. H10-15064 discloses a living body in which three electrode layers and a connection layer for connecting each of the electrode layers to a connector such as an electrocardiogram are formed by printing or applying a conductive substance on a nonwoven base sheet. An electrode is disclosed. However, the biological electrode disclosed in Japanese Utility Model Laid-Open No. 4-42803 discloses
Since the base material is a non-woven fabric, the printed or applied conductive substance easily penetrates into the base material, and therefore, an insulating layer is also provided on the back surface of the base material. In addition, since the base material is a nonwoven fabric in which a conductive substance is easily diffused, it is difficult to accurately control the dimensions of the electrode layer and the connection layer. Therefore, a short circuit is prevented by interposing an insulating layer between each electrode layer and the connection layer. That is, since these layers are exposed on the surface, there is a risk of short-circuiting easily due to contact with a living body or water droplets unless a sufficient space is provided between the layers. Therefore, there is a problem that the number of steps is increased to form the insulating layer.

In Japanese Unexamined Utility Model Publication Nos. 63-158309 and 63-158310, a knitted fiber base material is used as a base material. Since an insulating layer needs to be provided, there is a problem that the number of steps for printing the insulating paint increases.
Japanese Patent Application Laid-Open No. 2-268740 describes a bioelectrode in which an electrode member is mounted in a cutout provided in a base material.
Since the electrode member and the lead portion connected thereto are formed separately, there is a problem that the number of steps increases.

[0005] Japanese Patent Application Laid-Open No. 5-70552 discloses that two electron conductive layers are separately provided on a non-conductive sheet such as a plastic sheet, and a conductive adhesive layer is formed on the surface of each electron conductive layer. An electrode provided with an agent is disclosed. In this electrode, a hole penetrating the non-conductive sheet from each of the electron conductive layers is provided, and a connector for electrically connecting to the outside is attached to the hole. A film such as an adhesive tape is interposed between the connector and the conductive adhesive to prevent the metal connector from corroding due to contact with the conductive adhesive. Therefore, there is a disadvantage that the structure is complicated and the cost is high.

An object of the present invention is to solve the above-mentioned technical problems and to provide a method of manufacturing a multipolar bioelectrode which has a small number of parts and can be manufactured easily and inexpensively.

[0007]

SUMMARY OF THE INVENTION The multipolar bioelectrode of the present invention
The non-conductive strip-shaped base sheet made of a resin film, a plurality of electrode element portions formed on the surface at both ends of the base sheet and separated from each other, A multi-polar bioelectrode comprising a terminal connected to an electrode element, and a conductive adhesive gel layer provided on each of the electrode elements.
(1) Both surfaces are easily peelable.
Forming a conductive adhesive gel sheet with the sheet adhered,
(2) The conductive ink is patterned by printing.
The above described electrode having a repetitive pattern continuous on both end sides on the base sheet.
(3) forming the pole element portion and the terminal portion integrally;
Make the conductive adhesive gel sheet the same width as the width of the electrode element part.
Protection of one side of the slit and sticky surface protection sheet
The sheet is peeled off and the surface of the electrode element section is
The conductive adhesive gel sheet is continuously attached
(4) The adhesive sheet obtained in (3) is
The method is characterized in that the conductive adhesive gel layer is formed for each electrode element portion by cutting at each lit width .

As described above, since a plurality of electrode element portions are provided on one base sheet, each electrode element portion can be attached to a living body while maintaining a predetermined interval. Also,
Since the terminal portion connected to the electrode element portion is formed integrally with the electrode element portion and has a structure protruding from the conductive adhesive layer, the connection tool may be connected to this terminal portion.
For this reason, as described in Japanese Patent Application Laid-Open No. 5-70552, in order to prevent the metal fittings from being corroded due to the contact between the fittings and the conductive adhesive, the connection fittings and the conductive adhesive are mixed. There is no need to interpose a film such as an adhesive tape between them, so that the number of parts is reduced, the structure and manufacture are simpler, and the connection of the connecting tool is also easier. Further, since the conductive pressure-sensitive adhesive layer is formed for each electrode element portion, a short circuit via the conductive pressure-sensitive adhesive layer can be reliably prevented.

The electrode element portion and the terminal portion can be integrally formed by pattern printing of a conductive ink. In the present invention, a lead portion may be connected to the electrode element portion via a terminal portion, and the terminal portion and the lead portion may be formed integrally with the electrode element portion.
By thus integrally providing the lead portion, the connection between the biological electrode of the present invention and a measuring device such as an electrocardiogram is further facilitated.

The electrode element portion, the terminal portion, and the lead portion can be integrally formed by pattern printing in the same manner as described above, so that the number of components and the number of steps do not increase.

[0011]

DESCRIPTION OF THE PREFERRED EMBODIMENTS In the present invention, the non-conductive base sheet made of a resin film is not particularly limited, but the distance between a plurality of electrode element portions is fixed at the time of sticking to a human skin surface. It is preferable that the film has no elasticity and a relatively high waist strength so that the film can be kept at a high strength. As such a resin film, for example, a film having a thickness of 10 to 500 μm, such as polyethylene terephthalate (PET), polyvinyl chloride, polyethylene, or polypropylene, is preferably used. In particular, it is preferable to use a PET film having high waist strength and easy printing.

The electrode element portion, the terminal portion, and the lead portion provided as necessary are formed using a predetermined conductive material. Examples of such a conductive substance include silver, a mixture of silver-silver chloride, nickel, a metal such as molybdenum, or a conductive paste prepared by mixing carbon black, graphite, or the like alone or in combination of two or more. Can be Further, the electrode element portion, the terminal portion, and the lead portion can also be formed by laminating a metal foil such as silver.

As the conductive pressure-sensitive adhesive layer, any material can be used as long as it has conductivity and has little irritation to the skin and has an adhesive force, and is not particularly limited. Are, for example, polyacrylamide, sodium polyacrylate, polyacrylic acid derivatives such as polyacrylates, polyvinylpyrrolidone, poly-N-vinylamide derivatives such as poly-N-vinylacetamide,
A conductive adhesive gel containing polyurethane or the like as a matrix and containing water, an electrolyte salt or the like can be suitably used.

Next, an example of the biological electrode of the present invention will be described with reference to FIGS. As shown in these figures,
The base sheet 1 is formed in a strip shape, and electrode element portions 2 and 2 are formed at both ends thereof (see FIG. 2), and inward from the electrode element portions 2 and 2, that is, in directions facing each other. And terminal portions 3 and 3 are respectively extended. Further, conductive adhesive layers 4 and 4 are provided on the electrode elements 2 and 2. In the example shown in FIGS. 1 and 2, each conductive adhesive layer 4 covers the entire surface of the electrode element portion 2.

At the ends of the terminals 3, 3, connecting members 5, 5 (clips) for connecting the element portions 2, 2 to an external device are attached. The electrode element part 2, 2
Is set according to the application so that the distance d between them is constant in order to obtain an accurate measurement or a therapeutic effect.
The distance d is set to, for example, about 10 to 100 mm.

Each of the electrode element portions 2 and the terminal portions 3 are integrally formed by pattern printing. For the pattern printing, for example, screen printing or the like is preferably adopted, but it is not particularly limited. The electrode element portion 2 and the terminal portion 3 formed by printing have a thickness of 2 to 2 in a dry state after printing.
It is 30 μm, preferably 5 to 15 μm. The conductive pressure-sensitive adhesive layer 4 has a thickness of 0.1 to 2.5 mm, preferably 0.2 to 1.5 mm. The conductive pressure-sensitive adhesive layer 4 covers the entire surface of the electrode element portion 2 to enhance the adhesion between the electrode element portion 2 and the skin.

When an electrocardiogram is measured using the biological electrodes shown in FIGS. 1 and 2, the lead wire of the electrocardiograph is connected to a connector 5 attached to the tip of each terminal 3. The connection tool 5 may be attached to the terminal portion 3 at the time of manufacturing the electrode, or may be attached at the time of measurement. The connection tool 5 is not particularly limited, but for example, a snap that can be easily attached and detached can be suitably used. The snap is made of a metal such as copper or brass or a metal obtained by plating the surface of the metal with nickel or the like, and has a head penetrating the base material sheet 1 and a back side (a surface on which the electrode element portion 2 and the terminal portion 3 are formed). , And a flange at the end thereof is locked to the terminal portion 3. At this time, in order to prevent the snap from coming off, the flange of the snap may be adhered to the surface of the terminal 3 with an adhesive or the like, or the flange may be fixed to the terminal 3 with an appropriate adhesive film. You may.

Next, a method of manufacturing a bioelectrode according to the present invention will be described. The conductive adhesive gel forming the conductive adhesive layer 4 is as follows.
It is used in the form of a sheet in which an easily peelable surface protection sheet (for example, a film made of polyester, polypropylene or the like) is pasted on both sides in advance. On the other hand, the base sheet 1 may be used in the form of a roll obtained by winding a long film, or may be used in a state of being cut into a predetermined size. In any case, as shown in FIG. 9, a paste of a conductive substance is printed (such as screen printing) on the surface of the base sheet 1 to form the electrode element portion 2 and the terminal portion 3 having a continuous and repeated pattern. I do. Then, the protective sheet on one side of the surface protective sheet adhered to both sides of the sheet of the conductive adhesive gel is peeled off, and the sheet-shaped conductive adhesive gel is removed from the base sheet 1.
It is stuck on the surface of the upper electrode element portion 2. At that time, since the conductive pressure-sensitive adhesive gel has tackiness, the conductive pressure-sensitive adhesive layer 4 can be easily formed on the electrode element portion 2 simply by pressing without using an adhesive or the like. In addition, the sheet of the conductive adhesive gel is slit into a width substantially equal to the width W of the electrode element portion 2 before sticking.

After the formation of the conductive pressure-sensitive adhesive layer 4, the bioelectrode of the present invention is obtained by cutting the base sheet 1 at regular intervals along a cutting line C shown by a dashed line in FIG. In the cutting along the cutting line C, if cutting is performed while leaving only the surface protection sheet on the surface of the conductive adhesive gel layer 4,
At the time of use, the strip-shaped electrodes may be sequentially peeled off from the surface protection sheet, so that the handleability is improved.

Also, instead of the printing pattern shown in FIG.
A print pattern as shown in FIG. 10 may be used. FIG.
In the print pattern 0, the electrode terminal portions 3 'and 3' are simpler than those shown in FIG. 9, so that printing is facilitated and the pattern becomes more suitable for mass production. There is. Others are the same as FIG.
The same reference numerals as in FIG.

Another example of the multipolar bioelectrode of the present invention is shown in FIGS. The bioelectrode shown in FIGS. 3 and 4 has terminal portions 31 and 31 formed outward from each other. In addition, the conductive adhesive layers 41, 41 are provided in the electrode element portions 21, 21.
Since it is formed with a wide area covering the entire surface from the surface to the base sheet 11, there is an advantage that the adhesiveness and adhesion to the skin are excellent.

The terminal portion 3 is connected to the electrode element portions 21 and 21.
Even when the first and 31 are provided outward, they can be manufactured in the same manner as the method shown in FIGS. The shape of the electrode element portion in the present invention is not particularly limited, and may be, for example, an electrode element portion 22 having the same width as the terminal portion 32 as shown in FIG. In this case, a portion covered with the conductive pressure-sensitive adhesive layer 42 becomes the electrode element portion 22.

FIG. 6 shows still another example of the present invention. The figure shows a six-pole type bioelectrode, and each electrode element portion 23
Are formed on a plurality of tongues 6, 6,... Protruding from the side of the ribbon-shaped base material sheet 13, respectively. A terminal portion 33 and a lead portion 7 are formed integrally with each electrode element portion 23, and the lead portion 7 extends from each electrode element portion 23 to one end 8 of the base material sheet 13 via the terminal portion 33. When a connector (not shown) is attached to this one end 8 and connected to a terminal of an electrocardiograph or the like, the handling of the multipolar bioelectrode is improved.

A conductive pressure-sensitive adhesive layer 43 is provided on the entire surface of each tongue 6 including the electrode element section 23, and covers the electrode element section 23. The terminal portion and the lead portion in the present invention may be used in an exposed state, but may be covered with an insulating paint as needed. The bioelectrode shown in FIG. 7 has an insulating layer 9 provided on the surface of a terminal portion as shown in FIGS. The insulating layer 9 can be formed, for example, by coating a commercially available insulating ink or insulating paint. The insulating layer 9 may be formed on the entire surface of the base sheet 1 except for the conductive pressure-sensitive adhesive layer 4, or may be formed only on a portion that covers the terminal portion 3 and the lead portion 7.

Further, as shown in FIG. 8, after the insulating layer 9 is provided, an adhesive layer 10 may be provided on the surface of the insulating layer 9 to enhance the adhesion to the skin surface. The adhesive layer 10 may be an ordinary medical adhesive or a polymer gel adhesive with little skin irritation.

[0026]

As described above, according to the present invention, since a plurality of electrode element portions are provided on one base sheet, each electrode element portion is attached to a living body while maintaining a predetermined interval. Measurement or treatment can be performed accurately and easily. Further, since the terminal portion connected to the electrode element portion is formed integrally with the electrode element portion and has a structure protruding from the conductive adhesive layer, the connection tool may be connected to this terminal portion, Therefore, it is possible to reduce the number of other parts for connecting the connecting parts, so that the number of parts is small, the structure and the manufacturing are simpler, the manufacturing can be performed at low cost, and the connecting of the connecting parts can be easily performed. There is.

Further, since the electrode element portion and the terminal portion can be integrally formed by pattern-printing a conductive ink, manufacturing is facilitated. Furthermore, in the present invention, by providing a lead portion integrally with the electrode element portion via a terminal portion, the connection between the biological electrode of the present invention and a measuring device such as an electrocardiogram is further facilitated.

[Brief description of the drawings]

FIG. 1 is a partially cutaway plan view showing an embodiment of the present invention.

FIG. 2 is a sectional view taken along line XX shown in FIG.

FIG. 3 is a partially cutaway plan view showing another embodiment of the present invention.

FIG. 4 is a sectional view taken along line YY shown in FIG. 3;

FIG. 5 is a partially cutaway plan view showing a modification of the bioelectrode of FIG. 4;

FIG. 6 is a partially cutaway plan view showing an embodiment provided with a lead wire in the present invention.

FIG. 7 is a partially enlarged cross-sectional view showing an embodiment in which an insulating layer is provided on the biological electrode of FIG.

FIG. 8 is a partially enlarged cross-sectional view showing an embodiment in which an insulating layer and an adhesive layer are provided on the biological electrode of FIG.

FIG. 9 is a plan view showing an example of a printed pattern of a conductive material on a base sheet in the production of the bioelectrode of the present invention.

FIG. 10 is a plan view showing another example of a printed pattern of a conductive material on a base sheet in the production of the bioelectrode of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Base material sheet 2 Electrode element part 3 Terminal part 4 Conductive adhesive layer 5 Connector 7 Lead part

Continuation of the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61B 5/0408 A61B 5/0478 A61B 5/0492 A61N 1/04

Claims (3)

(57) [Claims] 1. A non-conductive strip-shaped base sheet made of a resin film, a plurality of electrode element portions formed on the surface at both end sides of the base sheet so as to be separated from each other; A multipolar bioelectrode comprising a connected terminal portion and a conductive adhesive gel layer provided on each of the electrode element portions.
When manufacturing, (1) easily peelable surface protection sheet on both sides
(2) forming a conductive adhesive gel sheet with adhesive
By pattern printing of conductive ink, the substrate
The electrode element having a repetitive pattern continuous on both end sides on the sheet
(3) forming the terminal portion and the terminal portion integrally;
Slip the adhesive gel sheet to the same width as the electrode element
Protective sheet on one side of the sticky surface protective sheet
Is peeled off and the slit is formed on the surface of the electrode element portion.
The conductive adhesive gel sheet is continuously attached.
(4) The adhesive sheet obtained in the above (3) is
Cutting at every width, and forming the conductive adhesive gel layer for each electrode element portion .
Construction method . 2. A method for manufacturing a multipolar bioelectrode according to claim 1, wherein a lead portion is connected to said electrode element portion via a terminal portion, and said terminal portion and said lead portion are formed integrally with said electrode electronic portion.
Law . 3. The electrode element section, the terminal section and the lead section.
Is formed integrally by pattern printing using conductive ink
The method for producing a multipolar bioelectrode according to claim 2 .