JP3737871B2 - Limb lead electrode pad - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a limb lead electrode pad useful for electrocardiogram measurement, and more particularly to a limb lead electrode pad that can be used repeatedly by attaching it to an electrode plate of a clip-type limb pinching jig used for electrocardiogram measurement. is there.
[0002]
[Prior art]
The limb induction electrode pad is basically composed of a porous substrate and a conductive hydrogel layer provided on both sides thereof, and the conductive hydrogel layers on both sides are electrically connected to each other through the porous substrate. Has a structure. In use, the limb induction electrode plate is adhered to one conductive hydrogel layer, and the remaining conductive hydrogel layer is adhered to the skin of the living body to be examined. Various problems occur in the conventional limb induction electrode pads during repeated use, and proposals have been made to solve such problems.
[0003]
For example, if the conductive water-containing gel layers provided on both surfaces of the porous substrate have the same area and thus have the same adhesive strength, hold the electrode plate after inspection and hold the limb induction electrode pad. When trying to peel off from the skin of a subject to be examined, there is often a problem that the pad is taken on the skin surface. In order to solve this problem, Japanese Utility Model Publication No. 63-48245 discloses a window made of a non-adhesive material for adjusting the adhesive area on the conductive hydrogel layer on the side to be adhered to the skin of the subject. A technique for installing a frame is disclosed. By installing this window frame, the area of the conductive hydrogel layer becomes smaller than that of the back surface and the adhesive strength is reduced, and the boundary portion between the conductive hydrogel layer and the window frame functions as a peeling start part. Thus, the above problem is solved. However, in this technique, since the electrode plate is still in contact with the same layer only with the weak adhesive force of the conductive hydrogel layer, the electrode plate is poorly fixed, which often hinders inspection.
[0004]
In order to improve the contact force between the electrode plate and the conductive hydrogel layer, Japanese Patent Application Laid-Open No. 5-200007 discloses that the area of the porous substrate is slightly widened and an adhesive portion is provided only on the peripheral portion of one side. A technique for adhering the limb induction electrode plate with the adhesive strength of the conductive hydrogel layer and the adhesive strength of the adhesive portion is disclosed.
Although this technique solves the above-mentioned problem of electrode plate fixing, this technique requires that the porous substrate be larger than the conductive hydrogel layer in order to secure the adhesive part. Since the sizes of the substrate and the conductive hydrous gel layer are different from each other, there is a problem that it is not suitable for continuous mass production by punching and is necessarily expensive.
[0005]
[Problems to be solved by the invention]
Therefore, in view of the above, the present invention provides a limb induction electrode pad that is excellent in fixability of the limb induction electrode plate and suitable for mass production.
[0006]
[Means for Solving the Problems]
The summary of the means for solving the above-mentioned problems in the present invention is as follows.
(1) One side of the porous substrate has a pressure-sensitive adhesive portion disposed in a pattern over a substantially entire area of the one side and a conductive hydrogel layer provided on the remaining portion of the pattern, and is porous. A pad for extremity induction electrode, characterized in that it has a conductive hydrogel layer on the other surface of the substrate, and the conductive hydrogel layers on both surfaces are electrically connected to each other through the porous substrate.
(2) The limb induction electrode pad according to (1) above, wherein the conductive hydrogel layer on the other surface of the porous substrate is covered with a protective sheet having an opening window for skin contact.
(3) The limb induction electrode pad according to the above (2), wherein the area of the opening window is at least 2 cm ² .
(4) The limb induction electrode pad according to (2) or (3), wherein the protective sheet is a laminate of a plastic film and a hydrophilic nonwoven fabric.
(5) The limb induction electrode pad according to any one of (1) to (4), wherein both surfaces of the pad are covered with release paper.
(6) The limb induction electrode pad according to any one of (1) to (5) above, which has a bent portion.
(7) The limb induction electrode pad according to any one of (1) to (6), wherein the porous substrate is made of a mixture of hydrophilic fibers and hydrophobic fibers.
[0007]
[Action]
In the present invention, the pressure-sensitive adhesive portion is not provided only in the peripheral portion of the porous substrate as in the above-mentioned JP-A-5-200007, but is arranged in a pattern over substantially the entire area of one side of the porous substrate. Therefore, when manufacturing a pad of an embodiment of the present invention having a certain specific size, for example, first, it is continuously manufactured in the form of a wide and long sheet, and then continuously from any part of the long sheet to the desired specific size pad. Even if punching is performed, the pressure-sensitive adhesive portion is present substantially uniformly in any punching pad. Therefore, the limb induction electrode pad of the present invention is suitable for mass production and has an adhesive part, so that the fixation of the limb induction electrode plate is also excellent.
Each of the following (2) inventions is a preferred embodiment of the invention of (1), and the operation and effect of each of the inventions will be fully understood in the following description.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
An example of the structure of the limb induction electrode pad of the present invention will be schematically described with reference to the drawings. In the limb induction electrode pad of the present invention, one surface is a surface in contact with the skin, and the other surface is a contact surface with the limb induction electrode plate as described above, and FIG. FIG. 2 is a top view of the electrode plate contact surface. FIG. 3 is a cross-sectional view taken along line II ′ in FIG.
[0009]
In the limb induction electrode pad P shown in FIGS. 1 to 3, 1 is a porous substrate, 2 is a conductive hydrogel layer provided on the skin contact surface side of the porous substrate 1 (hereinafter referred to as skin surface gel). 3 is a conductive hydrogel layer (hereinafter abbreviated as an electrode surface gel layer) provided on the limb induction electrode plate (not shown) side on the porous substrate 1, and 4 is a porous substrate. 1 is an adhesive portion arranged in a muscle pattern on the limb induction electrode plate side on 1. The electrode surface gel layer 3 is provided so as to fill the remaining portion of the pressure-sensitive adhesive portion 4 having a stripe pattern shape, and is electrically connected to the skin surface gel layer 2 through the porous substrate 1. . 5 is a protective sheet coated on the skin surface gel layer 2, the back surface of which is adhered to the skin surface gel layer 2, and has an opening window 51 through which the skin surface gel layer 2 is exposed. is doing. The skin surface gel layer 2 can adhere to the skin of the living body through the opening window 51.
[0010]
The limb induction electrode pad P includes a rectangular main body portion P1 having an opening window 51 in the center and trapezoidal bent portions P2 and P2 on both sides of the main body portion P1. The main body portion P1 and the bent portions P2 and P2 are integrated with each other. In FIG. The main body portion P1 may have various shapes other than a square shape. When using the limb induction electrode pad P, first, the electrode surface gel layer 3 of the main body portion P1 is adhered onto a predetermined surface of the limb induction electrode plate, and then each of the bent portions P2 and P2 is bent to form the limb induction electrode plate. It sticks on the opposite surface of the predetermined surface. In the limb induction electrode pad of the present invention, the bent portions P2 and P2 are not necessarily required, but the limb induction electrode plate can be attached to the limb induction electrode plate by bending and adhering to the opposite side of the predetermined surface of the limb induction electrode plate. There is an advantage that the measurement of the electrocardiogram becomes more reliable and the electrocardiogram is stabilized. If the size of the bent portions P2 and P2 is excessively large, there is a problem that gel adheres to the bed or the like when measuring the electrocardiogram. It is preferable to have a size that can achieve the object.
[0011]
Since each surface of the skin surface gel layer 2 and the electrode surface gel layer 3 has adhesiveness, if a release paper (not shown) is provided on each layer, the limb induction electrode pad of the present invention when not in use Is easy to handle, and is effective in maintaining the tackiness of each layer. When the protective sheet 5 is installed on the skin surface gel layer 2, the release paper is applied on the protective sheet 5.
[0012]
The porous substrate 1 can hold the limb induction electrode pad of the present invention in the form of a flexible pad, and electrically connects the skin surface gel layer 2 and the electrode surface gel layer 3 on each surface thereof. As long as it has porosity that can be maintained in a state, in other words, permeability of the water-containing gel, there are no particular restrictions on the constituent materials and the substrate structure. In addition, since the adhesive part 4 is arrange | positioned in the pattern form on the single side | surface of the porous base | substrate 1, it has the rough surface which the adhesive part 4 tends to adhere, for example, a part of adhesive part 4 can throw. Those are preferred.
The porous substrate 1 may be various kinds of flexible materials, such as organic polymer perforated sheets, sponge-like foams, fiber aggregates, etc., and in particular, the permeability of the hydrogel and the anchoring property of the adhesive. From the viewpoint of ensuring a good balance, it is made of a fabric base material such as a woven fabric, a nonwoven fabric, or a knitted fabric made of a mixture of hydrophilic fibers such as rayon, cellulose, vinylon, and cotton and hydrophobic fibers such as polyester, polypropylene, and nylon. Things are recommended. In that case, the weight ratio of the hydrophilic fiber to the hydrophobic fiber is usually 90 (hydrophilic fiber): 10 (hydrophobic fiber) to 10:90, preferably about 70:30 to 30:70, and has a basis weight. The amount is about 10 to 100 g / m ² , preferably about ²⁰ to 65 g / m ² .
[0013]
The skin surface gel layer 2 and the electrode surface gel layer 3 are in an electrically conductive state with each other, and are interposed between the limb induction electrode plate and the living body skin surface to electrically connect both. The function to maintain. In order to maintain an electrically conductive state, it is preferable that both the gel layers 2 and 3 have appropriate adhesiveness and thickness so as to be in good contact with both the limb induction electrode plate or the biological surface. The total thickness of the layer 2 and the layer 3 including the thickness of the porous substrate 1 is about 0.1 to 3.0 mm, preferably about 0.5 to 2.0 mm.
[0014]
The conductive hydrogels constituting the skin surface gel layer 2 and the electrode surface gel layer 3 may be of the same chemical type or different from each other, and have been conventionally known or used in the art. May be. Some preferred examples of the above-mentioned conductive hydrogel composition exhibiting moderate tackiness are as follows: Karaya gum, gelatin, polyacrylic acid or a salt thereof, acrylic polymer, polyacrylamide, polyvinyl alcohol, carboxymethylcellulose, polyurethane, etc. A water-containing composition comprising at least one water-soluble or water-dispersible polymer and at least one electrolyte such as sodium chloride, potassium chloride, or lithium chloride.
[0015]
The amount of water contained in the conductive hydrogel is usually about 5 to 50% by weight, preferably about 10 to 30% by weight. Further, in order to impart skin adhesion and water retention, it contains at least one kind of alcohols such as glycerin, polyethylene glycol and polypropylene glycol, particularly polyhydric alcohols, preferably 5 to 70% by weight, preferably about 20 to 50% by weight. It is desirable to make it. In order to increase the internal cohesive strength of these compositions, it is preferable to apply an appropriate crosslinking means. As a particularly preferred composition, glycerin, water, electrolyte, etc. are added to polyacrylic acid or polyacrylate in terms of quality stability, adhesion to the skin (adhesion), conductivity, shape retention, etc. And hydrous gels obtained by appropriate crosslinking means.
[0016]
The pressure-sensitive adhesive part 4 can be formed using various known pressure-sensitive adhesives that are excellent in adhesion to limb induction electrodes such as acrylic, rubber-based, silicon-based, and vinyl ether-based, and the thickness of the pattern is usually It is about 5-100 micrometers, Preferably it is about 10-50 micrometers. The pressure-sensitive adhesive part 4 is arranged in a pattern over substantially the entire area of one side of the porous substrate 1. The pattern shape is arbitrary as long as the pressure-sensitive adhesive portion 4 is scattered over a substantially entire region without being hardened on one side of the porous substrate 1 on the side of the limb induction electrode. In addition to the streak pattern shown in FIG. In addition, the ratio of the average total area of the patterned adhesive part 4 and the average total area of the electrode surface gel layer 3 on the surface on the limb induction electrode side of the porous substrate 1 is that of the patterned adhesive part 4 The electrode surface gel layer 3 usually has a thickness of about 0.5 to 9, preferably about 1 to 4.
[0017]
The protective sheet 5 shown in FIG. 1 and FIG. 3 is not necessarily essential in the present invention, but its presence can exhibit the following effects.
i) When the protective sheet 5 is not used, if the entire surface of the adhesive skin surface gel layer 2 is exposed, handling after removing the release paper is possible even if the release paper is applied to the surface. Although inconvenient, the presence of the protective sheet 5 facilitates handling even after the release paper is removed.
ii) Since the conductive hydrogel forming the skin surface gel layer 2 and the electrode surface gel layer 3 has insufficient mechanical strength, when the pad for extremity induction electrode of the present invention is used repeatedly, the layer 2 3 ends easily. However, when the protective sheet 5 is placed on the skin surface gel layer 2, the end portion of the skin surface gel layer 2 can be mechanically protected. Furthermore, since the limb induction electrode pad of the present invention is generally a thin sheet-like object, the mechanical protection effect of the protective sheet 5 extends to the electrode surface gel layer 3. Both end portions are protected, and the repeated usability of the limb induction electrode pad of the present invention is greatly improved.
iii) Since the protective sheet 5 has an opening window 51 through which the skin surface gel layer 2 is exposed, substantially the same effect as the technique disclosed in the Japanese Utility Model Publication No. 63-48245 described above, that is, the test object Peeling from the skin is much easier.
[0018]
Therefore, the protective sheet 5 may be formed of various materials as long as the above-described effects can be obtained and the flexibility of the limb induction electrode pad of the present invention is not substantially impaired. Some examples of such forming materials include organic polymer films such as polyethylene, polypropylene, nylon, polyester, polyurethane and polyvinyl chloride, organic polymer fiber paper such as polyester, polypropylene, rayon and cellulose, nonwoven fabric, Examples thereof include fiber sheets such as woven fabric, and laminates such as a laminate of at least one of the above films and at least one of the fiber sheets.
[0019]
The thickness of the protective sheet 5 is usually about 10 to 200 μm, preferably about 20 to 150 μm. Among the various sheets described above, a laminate of an organic polymer film having a thickness of about 10 to 50 μm and a nonwoven fabric or paper having a basis weight of about 10 to 50 g / m ² is particularly preferable. It is preferable to use a hydrophilic fiber material such as rayon or cellulose and attach this surface to the surface of the skin surface gel layer 2.
The area of the opening window 51 provided in the protective sheet 5 is at least 2 cm ² , preferably about 3 to 10 cm ² .
[0020]
As described above, for the purpose of protecting each surface of the skin surface gel layer 2 and the electrode surface gel layer 3, it is preferable to provide release paper on both surfaces of the pad. The release paper may be a well-known one, for example, various plastic films, paper, or a laminate such as paper laminated with an olefin resin. Further, if necessary, one side or A material obtained by applying a silicone resin or a fluorine-containing resin on both sides can also be used.
[0021]
Next, an example of a method for producing the limb induction electrode pad of the present invention will be described. The formation of the skin surface gel layer 2, the electrode surface gel layer 3, and the pressure-sensitive adhesive part 4 may be arbitrary, but the pressure-sensitive adhesive is obtained when the conductive hydrous gel is attached to the surface of the porous substrate 1. Since the part 4 is not easily disposed and the adhesive strength to the porous substrate 1 is low and unstable, the adhesive part 4 is disposed on the porous substrate 1 first, and then the skin. It is preferable to form the surface gel layer 2 and the electrode surface gel layer 3. The pattern-like arrangement of the pressure-sensitive adhesive part 4 is carried out batchwise or continuously by printing by flat or rotary screen printing, application by a computer-operated application / drawing machine, or other known arrangement means. Can do.
[0022]
The skin surface gel layer 2 and the electrode surface gel layer 3 are formed by applying a solution for forming a conductive hydrogel on the porous substrate 1 by a known method such as a roll coater, reverse coater, gravure printer, doctor blade, bar coater or the like. Then, it is formed by crosslinking and gelation by means of heating, ultraviolet irradiation, electron beam irradiation or the like. In that case, the skin surface gel layer 2 and the electrode surface gel layer 3 may be formed separately from each other, or the gel forming solution is applied to only one surface of the porous substrate 1 for forming the skin surface gel layer 2. The electrode surface gel layer 3 may be formed by the solution that is applied and exuded by allowing the adhesive portion 4 on the opposite surface of the porous substrate 1 to permeate the remaining portion arranged in a pattern. Of course, conversely, in order to form the electrode surface gel layer 3, the skin surface gel layer 2 may be formed with the solution applied to only one surface of the porous substrate 1 and exuded on the opposite surface. Further, instead of directly applying the conductive hydrogel forming solution to the surface of the porous substrate 1, the solution is applied on the above-mentioned release paper, and the surface of the applied solution layer is used as the porous substrate 1 side. The skin surface gel layer 2 and the electrode surface gel layer 3 can also be formed by covering the release substrate on the porous substrate 1. After the skin surface gel layer 2, the electrode surface gel layer 3, and the adhesive portion 4 are formed, a protective sheet 5 having aperture windows 51 opened in advance at a constant pitch is pasted on the surface of the skin surface gel layer 2, and finally The limb lead electrode pad of the present invention can be obtained by punching into a desired product shape.
[0023]
【Example】
Hereinafter, the present invention will be described in more detail with reference to FIGS.
As the porous substrate 1, a non-woven fabric having a basis weight of 50 g / m ^{2 made} of a mixture of 70% rayon fiber and 30% polyester fiber was used. A pressure-sensitive adhesive part 4 is formed by applying an acrylic pressure-sensitive adhesive partially cross-linked with an isocyanate-based cross-linking agent on one side with a fountain coater and applying it in a stripe pattern with a thickness of 25 μm, a width of 2 mm, and a spacing of 4 mm. Then, a release paper laminated with an olefin resin was coated thereon.
A conductive hydrogel solution is prepared by mixing an epoxy-based crosslinking agent with a composition comprising 20 parts by weight of sodium polyacrylate, 40 parts by weight of glycerin, 40 parts by weight of water, and 0.5 parts by weight of sodium chloride. The adhesive substrate 4 is coated with a knife coater on the surface opposite to the surface on which the pressure-sensitive adhesive portion 4 is formed, and leached also on the remaining portion of the pressure-sensitive adhesive portion 4 on the other surface side. The electrode surface gel layer 3 was formed simultaneously. At that time, the adhesive part 4 formed in a streak pattern on the porous substrate 1 functions as a spacer, and the hydrous gel exudes to the remaining part of the adhesive part 4 so as to adhere to the limb induction electrode plate. The adhesive part 4 and the smooth electrode surface gel layer 3 which do not impair the property were formed.
Next, a 15 μm-thick protective sheet 5 comprising a laminate of a polyethylene film and a rayon nonwoven fabric having a basis weight of 20 g / m ² and having a 22 mm × 24 mm square opening window 51 is used with the nonwoven fabric side as the skin surface gel layer 2 side. It was bonded to the surface of the layer, and a release paper made of a polyester film was placed thereon.
Thus, as shown in FIGS. 1 to 3, a limb induction electrode pad P composed of the main body portion P <b> 1 and the bent portions P <b> 2 and P <b> 2 in which the opening window 51 is located at the center was formed. The bent portions P2 and P2 have a shape and a size that do not protrude from the limb induction electrode plate at all.
When the limb induction electrode pad P produced above is affixed to a clip-type limb pinching jig electrode plate, the skin surface gel layer 2 and the electrode surface gel layer 3 are in a conductive state via the porous substrate 1. Therefore, the electrical signal from the living body can be stably taken out, and the adhesive part 4 and the electrode surface gel layer 3 can be securely adhered to the limb induction electrode plate, and can be repeatedly attached and detached to the human wrist. Sufficient fixation to the electrode was obtained.
Furthermore, the skin surface gel layer 2 was protected by the protective sheet 5 except for the portion exposed from the opening window 51 in contact with the skin, and the pad itself could be prevented from being damaged even after repeated use.
[0024]
【The invention's effect】
As described above, the limb induction electrode pad of the present invention improves adhesion and fixation to the limb induction electrode plate by combining the hydrated gel layer and the adhesive part, and stably extracts electrical signals from the living body. Further, by combining a protective sheet having an opening window, the pad is not easily broken even after repeated use and has sufficient durability. Moreover, since the adhesive part exists in a pattern, the limb induction electrode pad of the present invention can be mass-produced by punching.
[Brief description of the drawings]
FIG. 1 is a top view of a skin contact surface according to an embodiment of the present invention.
FIG. 2 is a top view of an electrode contact surface according to an embodiment of the present invention.
FIG. 3 is a cross-sectional view taken along the line II ′ in FIG.
[Explanation of symbols]
P limb induction electrode pad P1 limb induction electrode pad body part P2 limb induction electrode pad bent part 1 porous substrate 2 conductive hydrous gel layer 3 provided on the skin contact surface side provided on the limb induction electrode plate side Conductive hydrous gel layer 4 Adhesive part 5 arranged in a streak pattern Protective sheet 51 Open window

Claims (6)

One side of a porous substrate made of a mixture of hydrophilic fibers and hydrophobic fibers has a pressure-sensitive adhesive portion disposed in a pattern over substantially the entire area of the one side and conductive water content provided in the remaining portion of the pattern. A conductive hydrogel layer on the other surface of the porous substrate, and the conductive hydrogel layers on both sides are electrically connected to each other through the porous substrate. Pad for limb induction electrode.   The limb induction electrode pad according to claim 1, wherein the conductive hydrogel layer on the other surface of the porous substrate is covered with a protective sheet having an opening window for skin contact. The limb induction electrode pad according to claim ² , wherein an area of the opening window is at least 2 cm ² .   The limb induction electrode pad according to claim 2 or 3, wherein the protective sheet comprises a laminate of a plastic film and a hydrophilic nonwoven fabric.   The limb induction electrode pad according to any one of claims 1 to 4, wherein both surfaces of the pad are covered with release paper.   The limb induction electrode pad according to any one of claims 1 to 5, which has a bent portion.

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