Medical electrode pads and separators

Abstract

The present invention provides a medical electrode pad with a structure that allows for suitable EOG sterilization of the medical electrode pad while the separator is attached to the conductive adhesive layer. [Solution] The medical electrode pad 100 is a flexible medical electrode pad comprising a flexible base material 10, an electrode 20 formed on the base material 10, a conductive adhesive layer 30 laminated on the electrode 20, and a separator 50 peelably attached on the conductive adhesive layer 30, wherein the separator 50 is a porous material having a plurality of openings 53 that penetrate through the front and back surfaces of the separator 50.

Description

Technical Field

[0001] The present invention relates to a medical electrode pad and a separator.

Background Art

[0002] Patent Document 1 describes an electrode pad (multipolar biological electrode in the same document) used by being attached to a living body. The electrode pad of Patent Document 1 has a base material (base material sheet in the same document), an electrode (electrode element part in the same document) formed on the base material, and a conductive adhesive layer (conductive adhesive layer in the same document) laminated on the electrode, and can be attached to a living body by the adhesive force of the conductive adhesive layer.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, although not described in Patent Document 1, electrode pads used by being attached to a living body generally originally include a separator that is detachably attached to the conductive adhesive layer. In that case, after peeling the separator from the conductive adhesive layer, the electrode pad is used by being attached to a living body.

[0005] Also, when the electrode pad is for medical use (when it is a medical electrode pad), sterilization treatment may be required during manufacturing. As methods of sterilization treatment, there are an autoclave using high-pressure steam, a physical method using radiation such as gamma rays or electron beams, and a chemical method using ethylene oxide gas (hereinafter, EOG). Among these, in the case of sterilization by high-pressure steam or radiation, it may affect the product function and appearance. In contrast, EOG sterilization using EOG can be performed under mild conditions, making it widely applicable to plastic products and electronic components, and thus suitable for medical electrode pads.

[0006] According to the inventors of this application, there is a need for performing EOG sterilization on medical electrode pads while the separator is attached to a conductive adhesive layer. However, even when EOG sterilization is performed on a medical electrode pad with a general separator attached to a conductive adhesive layer, it is difficult to penetrate the conductive adhesive layer with EOG, making it difficult to suitably sterilize the conductive adhesive layer with EOG.

[0007] The present invention has been made in view of the above problems, and provides a medical electrode pad and a separator with a structure that allows for suitable EOG sterilization treatment of the medical electrode pad while the separator is attached to a conductive adhesive layer. [Means for solving the problem]

[0008] According to the present invention, a flexible substrate and An electrode formed on the substrate, A conductive adhesive layer is laminated on the electrode, A separator is peelably attached to the conductive adhesive layer, A flexible medical electrode pad comprising, The aforementioned separator is a porous material having multiple openings that penetrate both the front and back surfaces of the separator, and a medical electrode pad is provided.

[0009] Furthermore, according to the present invention, a separator is used by being peelably attached to the conductive adhesive layer of a flexible medical electrode pad, which comprises a flexible substrate, an electrode formed on the substrate, and a conductive adhesive layer laminated on the electrode, A separator is provided, which is a porous material having multiple openings that penetrate both the front and back surfaces of the separator. [Effects of the Invention]

[0010] According to the present invention, it is possible to suitably perform EOG sterilization treatment on a medical electrode pad in a state where a separator is attached to a conductive adhesive layer.

Brief Description of the Drawings

[0011] [Figure 1] It is a schematic cross-sectional view of a medical electrode pad according to the first embodiment. [Figure 2] It is a schematic plan view of a medical electrode pad according to the first embodiment. [Figure 3] It is a schematic plan view of a separator according to the first embodiment. [Figure 4] It is a schematic back view of a separator according to the first embodiment. [Figure 5] It is a schematic cross-sectional view of a medical electrode pad according to Modification 1 of the first embodiment. [Figure 6] It is a schematic cross-sectional view of a medical electrode pad according to Modification 2 of the first embodiment. [Figure 7] It is a schematic plan view of a separator according to Modification 2 of the first embodiment. [Figure 8] It is a schematic cross-sectional view of a medical electrode pad according to the second embodiment. [Figure 9] It is a schematic plan view of a separator according to the second embodiment.

Modes for Carrying Out the Invention

[0012] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate. Note that each drawing is schematic, and the scales and numbers of each part (for example, the opening 53 and the surrounding structure) may not be consistent among the drawings.

[0013] 〔First Embodiment〕 First, the first embodiment will be described with reference to FIGS. 1 to 4. FIG. 1 corresponds to a cross section taken along line A-A of FIG. 2. As shown in FIGS. 1 and 2, the medical electrode pad 100 according to the present embodiment includes a flexible base material 10, an electrode 20 formed on the base material 10, a conductive adhesive layer 30 laminated on the electrode 20, and a separator 50 peelably attached to the conductive adhesive layer 30. The medical electrode pad 100 is a flexible medical electrode pad 100 having a porous material having a plurality of openings 53 penetrating through the front and back of the separator 50.

[0014] Further, the separator 50 according to the present embodiment is a separator 50 (FIGS. 3 and 4) used by being peelably attached to the conductive adhesive layer 30 of the flexible medical electrode pad 100 (FIGS. 1 and 2) including a flexible base material 10, an electrode 20 formed on the base material 10, and a conductive adhesive layer 30 laminated on the electrode 20. It is a porous material having a plurality of openings 53 penetrating through the front and back of the separator 50.

[0015] According to the present embodiment, the separator 50 is a porous material having a plurality of openings 53 penetrating through the front and back of the separator 50. Therefore, the separator 50 has good gas permeability. Therefore, when the EOG sterilization treatment is performed on the medical electrode pad 100 with the separator 50 attached to the conductive adhesive layer 30, the EOG can be satisfactorily supplied to the layer (conductive adhesive layer 30) directly below the separator 50 through the openings 53 of the separator 50. Therefore, the EOG sterilization of the conductive adhesive layer 30 can be suitably performed. That is, it is possible to suitably perform the EOG sterilization treatment on the medical electrode pad 100 with the separator 50 attached to the conductive adhesive layer 30. Further, since the separator 50 is a porous material having a plurality of openings 53, the contact area (contact area per unit area) between the conductive adhesive layer 30 and the separator 50 can be reduced. Therefore, it is possible to easily peel the separator 50 from the conductive adhesive layer 30 with a lighter force.

[0016] The following provides a more detailed explanation.

[0017] The base material 10 is an insulating and flexible film, and is made of a resin material such as PET (polyethylene terephthalate), PP (polypropylene), or PE (polyethylene). The thickness of the base material 10 is not particularly limited, but can be, for example, 5 μm or more and 50 μm or less.

[0018] The electrode 20 is formed on one surface of the substrate 10 (the top surface in Figure 1). The material of the electrode 20 is not particularly limited, but examples include aluminum, copper, or silver. The electrode 20 is a thin film with a thickness that does not hinder the flexibility of the medical electrode pad 100. The film thickness of the electrode 20 is not particularly limited, but can be, for example, 5 μm or more and 50 μm or less. The electrode 20 has an exposed portion that is exposed from the conductive adhesive layer 30 (not covered by the conductive adhesive layer 30). One end 40a of a lead 40, which is made of a conductive material, is joined to the exposed portion of the electrode 20 by a joining method such as crimping. This makes it possible to electrically connect the conductive adhesive layer 30 to external devices via the lead 40.

[0019] The conductive adhesive layer 30 is formed on one surface of the electrode 20 (the upper surface in Figure 1). The thickness of the conductive adhesive layer 30 is not particularly limited, but can be, for example, 5 μm or more and 1000 μm or less.

[0020] The conductive adhesive layer 30 includes, for example, a conductive organic polymer compound and an adhesive material. As the conductive organic polymer compound, at least one of polyanilines, polypyrroles, polythiophenes, and their derivatives can be used. Polyanilines, polypyrroles, and polythiophenes are conductive organic polymer compounds that have conductivity due to π-electron conjugation. Polyanilines are high molecular weight compounds in which the 2nd, 3rd, or Nth position of aniline is substituted with an alkyl group, alkoxy group, aryl group, sulfonic acid group, etc., having 1 to 18 carbon atoms. Examples include poly2-methylaniline, poly3-methylaniline, poly2-ethylaniline, poly3-ethylaniline, poly2-methoxyaniline, poly3-methoxyaniline, poly2-ethoxyaniline, poly3-ethoxyaniline, polyN-methylaniline, polyN-propylaniline, polyN-phenyl-1-naphthylaniline, poly8-anilino-1-naphthalenesulfonic acid, poly2-aminobenzenesulfonic acid, and poly7-anilino-4-hydroxy-2-naphthalenesulfonic acid.

[0021] Examples of polyaniline derivatives include polyanilines doped with or mixed with dopants. Examples of dopants include halide ions such as chloride ions, bromide ions, and iodide ions; perchlorate ions; tetrafluoroborate ions; hexafluorescens ions; sulfate ions; nitrate ions; thiocyanate ions; hexafluorisilicate ions; phosphate ions such as phosphate ions, phenylphosphate ions, and hexafluorescens ions; trifluoroacetate ions; alkylbenzenesulfonate ions such as tosylate ions, ethylbenzenesulfonate ions, and dodecylbenzenesulfonate ions; alkylsulfonate ions such as methylsulfonate ions and ethylsulfonate ions; or polymer ions such as polyacrylate ions, polyvinylsulfonate ions, polystyrenesulfonate ions (PSS), and poly(2-acrylamido-2-methylpropanesulfonic acid) ions. These may be used individually or in combination of two or more.

[0022] Polypyrroles are high molecular weight compounds in which the 1st, 3rd, or 4th position of pyrrole is substituted with an alkyl group or alkoxy group having 1 to 18 carbon atoms, and examples include poly-1-methylpyrrole, poly-3-methylpyrrole, poly-1-ethylpyrrole, poly-3-ethylpyrrole, poly-1-methoxypyrrole, 3-methoxypyrrole, poly-1-ethoxypyrrole, poly-3-ethoxypyrrole, etc. Examples of polypyrrole derivatives include those obtained by doping or mixing polypyrroles with dopants. The aforementioned dopants can be used.

[0023] Polythiophenes are high molecular weight compounds in which the 3rd or 4th position of a thiophene is substituted with an alkyl group or alkoxy group having 1 to 18 carbon atoms. Examples of high molecular weight compounds include poly3-methylthiophene, poly3-ethylthiophene, poly3-methoxythiophene, poly3-ethoxythiophene, and poly(3,4-ethylenedioxythiophene) (PEDOT). Examples of polythiophene derivatives include those obtained by doping or mixing polythiophenes with dopants. The dopants mentioned above can be used.

[0024] As a derivative of polythiophenes, a mixture of poly(3,4-ethylene oxide thiophene) (PEDOT) as a dopant and polystyrene sulfonate ions (PSS) (hereinafter referred to as "PEDOT:PSS") is preferred because it can achieve high conductivity, has a hydrophilic skeleton useful for retaining water molecules, and disperses easily in water.

[0025] As the adhesive material, a conductive adhesive composition containing a water-based emulsion adhesive is used. The water-based emulsion adhesive is not particularly limited as long as it has film-forming properties and adhesiveness, and examples include acrylic emulsion adhesives, vinyl acetate emulsion adhesives, and ethylene-vinyl acetate copolymer emulsion adhesives. According to the inventors' research, hydrogel-based adhesive layers, which are commonly used as conductive adhesive layers, tend to leave behind EOG after EOG sterilization. In contrast, the inventors' research has shown that a conductive adhesive layer containing a water-based emulsion adhesive and conductive resin particles suppresses EOG residue after EOG sterilization. For this reason, a preferred material for the conductive adhesive layer 30 is one containing a water-based emulsion adhesive and conductive resin particles.

[0026] The separator 50 is laminated on one side (the top surface in Figure 1) of the conductive adhesive layer 30. In this embodiment, the separator 50 is an insulating and flexible film (sheet). In other words, the separator 50 is in sheet form. The separator 50 is made of a resin material such as PET, PP, or PE.

[0027] In this embodiment, the separator 50 has multiple openings 53 formed by drilling. The method of drilling is not particularly limited, and may be a drill, a laser cut, or other method. The number and shape of the openings 53 are not particularly limited. For example, the planar shape of the openings 53 may be circular, but they may also have other shapes. The inner diameter D of the opening 53 is not particularly limited, but can be, for example, 10 μm or more and 5000 μm or less, and preferably 50 μm or more and 200 μm or less. Furthermore, the distance P between the centers of adjacent openings 53 is not particularly limited, but for example, it can be 30 μm or more and 10,000 μm or less, preferably 50 μm or more and 1,000 μm or less, and also preferably 100 μm or more and 500 μm or less. The thickness dimension T of the separator 50 (the thickness dimension T of the part other than the raised portion 54 described later) is not particularly limited, but for example it can be 10 μm or more and 500 μm or less.

[0028] As shown in Figure 1, in this embodiment, the portion surrounding the opening 53 in the separator 50 is a raised portion 54 that is raised toward one side of the separator 50. Furthermore, in the separator 50, the portion located on the back side relative to the raised portion 54 is conversely a recess. Therefore, the contact area between the separator 50 and the conductive adhesive layer 30 is reduced, making it easier to peel the separator 50 from the conductive adhesive layer 30. In addition, during EOG sterilization, the EOG can be effectively distributed to the areas of the conductive adhesive layer 30 corresponding to the recesses of the separator 50.

[0029] In this embodiment, the raised portion 54 is raised toward the opposite side from the conductive adhesive layer 30. That is, the raised portion 54 is raised toward the upper surface 52 (upper side) of the lower surface 51 and upper surface 52 of the separator 50. As a result, on the lower surface 51 of the separator 50, the portion corresponding to the raised portion 54 becomes an inclined surface 54b (a recess), and is separated above the conductive adhesive layer 30. Furthermore, since a curved inclined surface 54b is formed on the lower surface 51, the peelability of the separator 50 from the conductive adhesive layer 30 is further improved.

[0030] In Figure 1, the end face 54a of the raised portion 54 is shown to be flat and horizontally arranged. However, the shape and arrangement of the end face 54a are not limited to this example; for example, it may be mortar-shaped (with an opening 53 in the center).

[0031] One method for forming the raised portion 54 on the separator 50 is to produce a separator 50 having a number of raised portions 54 by coating the resin material constituting the separator 50 onto a plate having a number of protrusions corresponding to the lower surface 51 and opening 53 of the separator 50. However, the method for forming the raised portion 54 is not limited to this example. For example, after forming a number of openings 53 in a flat sheet-like separator 50, the peripheral edges of the openings 53 may be locally suctioned with negative pressure to raise them and shape them into raised portions 54.

[0032] In this embodiment, the surface of the separator 50 is coated with a release coating (not shown). This further improves the release properties of the separator 50 from the conductive adhesive layer 30. Release coatings are, for example, coatings made of silicone resin or fluororesin (such as PTFE). The release coating is formed, for example, on both the lower surface 51 and the upper surface 52 of the separator 50. The end surface 54a may or may not have a release coating.

[0033] When using the medical electrode pad 100, the separator 50 is peeled off from the conductive adhesive layer 30, and then the medical electrode pad 100 is attached to the body by the adhesive force of the conductive adhesive layer 30.

[0034] <Modification 1 of the first embodiment> Next, a modified example 1 of the first embodiment of the medical electrode pad 100 will be described using Figure 5. The modified medical electrode pad 100 differs from the medical electrode pad 100 according to the first embodiment described above in the respects described below, and is otherwise configured in the same way as the medical electrode pad 100 according to the first embodiment described above.

[0035] In this modified example, the separator 50 is the same as the separator 50 described in the first embodiment above, but inverted vertically (with the lower surface 51 and the upper surface 52 swapped). Therefore, the raised portion 54 is raised toward the conductive adhesive layer 30 side (downward side). In this case, depending on the properties (softness) of the conductive adhesive layer 30, the contact area between the conductive adhesive layer 30 and the separator 50 can be limited mainly to the end face 54a surrounding the opening 53. In other words, the contact between the separator 50 and the conductive adhesive layer 30 can be made to be close to line contact. Therefore, it can be expected that the peelability of the separator 50 from the conductive adhesive layer 30 will be further improved. Depending on the properties (softness) of the conductive adhesive layer 30, it is possible that the lower surface 51 other than the end face 54a may also be in contact with the conductive adhesive layer 30 in part or substantially entirely. However, since a release coating is applied to the surface of the separator 50, including the lower surface 51, the release properties of the separator 50 from the conductive adhesive layer 30 can be ensured.

[0036] <Modification 2 of the first embodiment> Next, a modified example of the first embodiment, a medical electrode pad 100, will be described using Figures 6 and 7. Figure 6 corresponds to a cross-section along line AA in Figure 7. The modified medical electrode pad 100 differs from the medical electrode pad 100 according to the first embodiment described above in the respects described below, and is otherwise configured in the same way as the medical electrode pad 100 according to the first embodiment described above. In this embodiment, the separator 50 does not have a raised portion 54, and the entire separator 50 is formed to be substantially flat. In this case as well, since the separator 50 has multiple openings 53, EOG sterilization can be performed effectively, and the separator 50 can be easily peeled off the conductive adhesive layer 30.

[0037] [Second Embodiment] Next, a second embodiment will be described using Figures 8 and 9. Figure 8 corresponds to a cross-section along line AA in Figure 9. The medical electrode pad 100 according to this embodiment differs from the medical electrode pad 100 according to the first embodiment described above in the respects described below, and is otherwise configured in the same way as the medical electrode pad 100 according to the first embodiment described above.

[0038] In the first embodiment and its modifications described above, an example was described in which a sheet-like separator 50 has multiple openings 53 formed by drilling holes. However, in this embodiment, the separator 50 is constructed by braiding wire 60 into a mesh. Therefore, it is possible to effectively reduce the contact area between the conductive adhesive layer 30 and the separator 50, and both the supply of EOG to the conductive adhesive layer 30 and the peeling of the separator 50 from the conductive adhesive layer 30 can be performed effectively.

[0039] The wire material 60 is constructed, for example, by braiding warp threads 61 and weft threads 62 together vertically and horizontally. In this embodiment, the grid pattern enclosed by adjacent pairs of warp threads 61 and adjacent pairs of weft threads 62 forms an opening 53. Figure 9 shows an example in which the wires 60 are braided in a square grid pattern, but the method of braiding the wires 60 is not particularly limited, and for example, it may be in a diagonal grid pattern. The material of the wire 60 is not particularly limited, but a preferred example is a chemical fiber made of resin material such as PET, PP, PE, or nylon. However, the material of the wire 60 may be other materials such as metal. In this embodiment as well, it is preferable that the surface of the separator 50 is coated with a release coating (not shown). The timing for applying the release coating can be, for example, after the wire 60 has been braided into a mesh. However, the release coating may also be applied to the wire 60 before it is braided into a mesh.

[0040] The diameter φ of the wire 60 is not particularly limited, but for example it can be 20 μm or more and 100 μm or less, preferably 30 μm or more and 80 μm or less, and preferably 50 μm or more. In this embodiment, the thickness dimension T of the separator 50 corresponds to the thickness dimension of the separator 50 at the intersection of the warp threads 61 and the weft threads 62.

[0041] For example, the diameter of the wire 60 is larger than the spacing between adjacent wires 60 (i.e., the mesh opening OP). In this case, the radius of curvature of the wire 60 is large, which prevents the wire 60 from becoming embedded in the conductive adhesive layer 30, and allows the wire 60 to make contact with the conductive adhesive layer 30 in a state close to line contact. Therefore, the separator 50 can be easily peeled off from the conductive adhesive layer 30, and the EOG can also be effectively applied to the conductive adhesive layer 30 on the underside of the wire 60 for sterilization. However, the present invention is not limited to this example, and the inner diameter D and the mesh opening OP may be set to the same dimensions, or the mesh opening OP may be larger than the inner diameter D. When the mesh opening OP is larger than the inner diameter D, the flow of EOG through the mesh opening OP becomes easier, so the supply of EOG to the conductive adhesive layer 30 becomes smoother.

[0042] Although embodiments and variations have been described above with reference to the drawings, these are merely examples of the present invention, and various other configurations can also be adopted.

[0043] This embodiment encompasses the following technical concepts. (1) A flexible base material and An electrode formed on the substrate, A conductive adhesive layer is laminated on the electrode, A separator is peelably attached to the conductive adhesive layer, A flexible medical electrode pad comprising, The separator is a porous material having multiple openings that penetrate both the front and back surfaces of the separator, and is used as a medical electrode pad. (2) The medical electrode pad according to (1), wherein the surface of the separator is coated with a release coating. (3) The separator is formed in a sheet shape, The portion surrounding the opening is a raised portion that is raised toward one side of the separator, as described in (1) or (2) above. (4) The medical electrode pad according to (3), wherein the raised portion is raised toward the opposite side from the conductive adhesive layer. (5) The medical electrode pad according to (3), wherein the raised portion is raised toward the conductive adhesive layer side. (6) The separator is formed by braiding wires into a mesh shape, as described in (1) or (2). (7) A medical electrode pad according to (6), wherein the diameter of the wire is greater than the distance between adjacent wires. (8) A separator used by being peelably attached to the conductive adhesive layer of a flexible medical electrode pad, which comprises a flexible substrate, an electrode formed on the substrate, and a conductive adhesive layer laminated on the electrode, A separator that is a porous material having multiple openings that penetrate through both the front and back surfaces. [Explanation of Symbols]

[0044] 10 Base material 20 electrodes 30 Conductive adhesive layer 40 Lead 40a One end 50 Separators 51 Bottom side 52 Top side 53 Opening 54 Ridge 54a End face 54b Slope 60 wire rod 61 Warp threads 62 weft threads D Inner diameter P center distance T Thickness Dimension φ wire diameter Opening eyes 100 Medical Electrode Pads

Claims

1. A flexible base material, An electrode formed on the substrate, A conductive adhesive layer is laminated on the electrode, A separator is peelably attached to the conductive adhesive layer, A flexible medical electrode pad comprising, The separator is a porous material having multiple openings that penetrate both the front and back surfaces of the separator, and is used as a medical electrode pad.

2. The medical electrode pad according to claim 1, wherein the surface of the separator is coated with a release coating.

3. The separator is formed in a sheet shape, The medical electrode pad according to claim 1 or 2, wherein the portion surrounding the opening is a raised portion that is raised toward one side of the separator.

4. The medical electrode pad according to claim 3, wherein the raised portion is raised toward the opposite side from the conductive adhesive layer.

5. The medical electrode pad according to claim 3, wherein the raised portion is raised toward the conductive adhesive layer side.

6. The medical electrode pad according to claim 1 or 2, wherein the separator is constructed by braiding wires into a mesh.

7. The medical electrode pad according to claim 6, wherein the diameter of the wire is greater than the distance between adjacent wires.

8. A separator used by being peelably attached to the conductive adhesive layer of a flexible medical electrode pad, which comprises a flexible base material, an electrode formed on the base material, and a conductive adhesive layer laminated on the electrode, A separator that is a porous material having multiple openings that penetrate through both the front and back surfaces.

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