JP2013192818A - Biological electrode having x ray transmissibility - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a biological electrode which can transmit X ray, is corrosion-resistant against the electrically conductive gel as constituent matter, and uses a low priced electrode element.SOLUTION: A biological electrode includes an electrically conductive gel, an electrode element placed on one side of the electrically conductive gel, and a cable for electrically connecting the biological electrode and external devices, wherein the electrode element is X-ray permeable and a thin film formed with an Al alloy which has corrosion-resistance against the electrically conductive gel.

Description

  The present invention relates to a biomedical (including medical) electrode having X-ray permeability. More specifically, the present invention relates to a biomedical electrode having X-ray permeability that can be used for a defibrillation electrode, a percutaneous pacing electrode, an electrocardiogram electrode, a counter electrode, and the like.

  Conventionally, electrode elements used for biomedical electrodes generally have a metal foil such as tin (Sn) or a button type such as stainless steel (SUS) (see, for example, Patent Document 1). In addition, in order to transmit X-rays, biological electrodes using a carbon film or a carbon resin as an electrode element have been proposed (see, for example, Patent Document 2).

Special Table No. 10-507651, page 8, last line to page 9, line 1 Paragraph “0017” of Japanese Patent Laid-Open No. 2008-86764

  However, in the case where X-rays do not pass through X-rays, such as Sn foils and SUS button-type electrode elements described in Patent Document 1, there is a problem that the electrodes attached to the body surface become shadows during X-ray examinations. is there. Therefore, there has been a problem that the electrodes attached to the body surface have to be attached while being shifted from the appropriate positions when performing the X-ray examination. Furthermore, there is a problem that it is necessary to peel off the electrode at the time of X-ray irradiation when the body is small like a child or a woman and the electrode cannot be displaced from the proper position or depending on the position of application. In addition, an electrode element using a metal such as Sn foil has problems such as corrosion (rusting) and discoloration of the conductive gel. In addition, the bioelectrode described in Patent Document 2 has a problem that the cost may not be met, for example, in the case of an electrode using a carbon film or a carbon resin as an element, it becomes expensive as a disposable electrode.

  It is also conceivable to use an aluminum (Al) foil as an electrode element in order to transmit X-rays. However, due to contact with a conductive gel that is one of the constituent members of a biological electrode, Since some Al foil corrodes, there exists a problem that it cannot be used practically. Therefore, to date, no biomedical electrode using an Al foil as an electrode element has been proposed, and no practical examples have been made.

  Therefore, the present invention provides a biomedical electrode using an electrode element that can transmit X-rays, is corrosive to a conductive gel that is a constituent member of a biomedical electrode, and is inexpensive. With the goal.

  The biomedical electrode of the present invention is characterized in that an Al alloy that transmits X-rays and has corrosion resistance to the conductive gel used in the biomedical electrode is used for the electrode element.

  According to the present invention, the electrode element is made of an Al alloy that transmits X-rays and has corrosion resistance with respect to the conductive gel used for the living body electrode. It becomes possible to make it an electrode for use.

As an embodiment of the biological electrode of the present invention, a disposable pad used for various defibrillators (for example, an external defibrillator, a semi-automatic defibrillator, an automatic external defibrillator (AED), etc.) It is the schematic expressed typically which decomposed | disassembled for every general structural member of the electrode. It is the schematic showing the state which mounted | wore the patient with the disposable pad electrode. FIG. 3A is a schematic view schematically showing a counter electrode used for one of the electric scalpels as one embodiment of the biomedical electrode of the present invention. 3B is a cross-sectional view taken along line AA in FIG. 3A.

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may be different from the actual ratios.

The biomedical electrode of the present invention includes a conductive gel layer having adhesiveness,
An electrode element disposed on one side of the conductive gel layer;
In order to electrically connect the electrode element and an external device, a biomedical electrode including a cable having one end connected to the electrode material,
The electrode element is a thin film formed using an Al alloy that transmits X-rays and has corrosion resistance to a conductive gel. By adopting such a configuration, it is possible to provide a biomedical electrode that is resistant to corrosion on a conductive gel and has an inexpensive X-ray permeability. Hereinafter, the biological electrode of the present invention will be described with reference to the drawings.

  FIG. 1 shows an embodiment of the biomedical electrode according to the present invention. Various defibrillators (for example, external defibrillators, semi-automatic defibrillators, automatic automatic external defibrillators (both AED and PAD) It is the schematic diagram which represented typically for every general structural member of the disposable pad electrode used for the said).

  As shown in FIG. 1, as a general component of the disposable pad electrode (also simply referred to as a pad electrode) 10, a label 11 and a rivet 12 are sequentially formed from the surface side (the side opposite to the surface attached to the front surface). , Ring washer 13a, base tape 14, electrode element (hereinafter also referred to as aluminum element) 15, ring washer 13b, cable 16, conductive gel 17, cover tape 18, and release sheet 19. Hereinafter, each component of the disposable pad electrode 10 and its function will be described.

(1) Label 11
The label 11 is provided in order to prevent the rivet 12 and the ring washer 13a from being exposed (= electricity flows when the exposed part touches a person, and an electric shock is caused), and covers the rivet 12 and the ring washer 13a. Then, it is bonded and fixed to the surface side of the base tape 14. The structure of the label 11 is usually an insulating sheet base material 11a having a circular shape that is slightly larger than the rivet 12 and the ring washer 13a, and the back surface of the sheet base material 11a (the surface to be attached to the front surface). And an adhesive layer 11b formed by applying and forming an adhesive.

  The label 11 is not particularly limited, and a conventionally known label may be used as it is.

Therefore, the material of the sheet base material 11a is not particularly limited, but may deteriorate within the warranty period of the product (disposable pad electrode 10 or AED using the electrode 10), or the release sheet 19 may be peeled off. When the pad electrode 10 is pasted on the body surface, it is desirable that it does not cause problems such as tearing. For example, insulating paper or various resins (for example, polyethylene (
PE), polyethylene terephthalate (PET), synthetic paper, etc.) can be used, and conventionally known ones can be used.

  Further, the thickness of the sheet base material 11a is also desirable since it does not get caught as it is thin if there is no problem such as tearing when the pad electrode 10 is applied to the body surface, and may be approximately in the range of 20 to 150 μm. That's fine. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  The material for the adhesive layer 11b is not particularly limited, and various conventionally known adhesives can be used. For example, natural rubber, acrylic and urethane adhesives and pressure-sensitive adhesives can be exemplified. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention. In particular, an acrylic pressure-sensitive adhesive having excellent adhesion to both insulating paper and resin (sheet base material 11a) and metal (rivet 12 and washer 13a) is preferable.

  The thickness of the adhesive layer 11b is sufficient if sufficient adhesive strength is obtained, and may be in a range of approximately 5 to 40 μm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  The shape (form) of the label 11 is not particularly limited, but a circular shape as shown in FIG. 1 is a commonly used shape. However, even shapes other than those exemplified above are adequately applicable as long as they do not impair the operational effects of the present invention.

  As the size of the label 11, it is usually sufficient that it is one size larger than the rivet 12 and the ring washer 13 a, and a circular shape having a diameter of about 3 (± 1) cm is generally used. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention.

(2) Rivet 12 and ring washers 13a and 13b
A so-called fixing member including the rivet 12 and the ring washers 13 a and 13 b is provided to fix the cable 16, the aluminum element 15, and the base tape 14. Therefore, as shown in FIG. 1, the both ends are bonded to the end portions of the aluminum element 15 and the base tape 14 (the central portion near the short side of the aluminum element 15 and the base tape 14 as shown in FIG. 1). Through-holes 14a and 15a for inserting the rivets 12 are provided so that the positions of the two through-holes match (overlap). Similarly, a fastener 16b having a through hole 16c of the same size as the through holes 14a and 15a is provided at the tip of the cable 16 electrically connected to the aluminum element 15. With this configuration, the rivet 12 is inserted into the ring washer 13a, the base tape 14, the through holes 14a and 15a of the aluminum element 15, the washer 13b, and the through hole 16c of the fastener 16b at the end of the cable body 16a. It is fixed by tightening.

  As the rivet 12 and the ring washers 13a and 13b, conventionally known existing ones can be used as they are.

  Accordingly, the material of the rivet 12 and the ring washers 13a and 13b is not particularly limited as long as it is a material having electrical conductivity. For example, a metal such as stainless steel (SUS) or Al (including an alloy). Etc. can be used.

  The size of the rivet 12 and the size of the inner diameters (through holes) of the ring washers 13a and 13b (both sizes are substantially the same) may be in a range of approximately 2 to 5 mm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention. Similarly, the size of the outer diameter of the ring washers 13a and 13b may be in a range of approximately 10 to 20 mm, and the thickness of the ring washers 13a and 13b may be in a range of approximately 0.5 to 2 mm. However, even when these sizes and thicknesses are out of the above ranges, they are sufficiently applicable as long as they do not impair the effects of the present invention. The length of the rivet 12 may be appropriately determined based on the thickness of the cable 16 to be fixed, the aluminum element 15 and the base tape 14 within a range that does not impair the effects of the present invention.

(3) Base tape 14
The base tape 14 is provided to support (fix or reinforce strength) the aluminum element 15. That is, the thin-film aluminum element 15 is provided as a reinforcing material so that it is not easily broken and becomes a wrinkle or bent. Moreover, it can be said that it is provided in order to prevent the surface side of the aluminum element 15 (the side opposite to the attachment surface to the body surface) from being exposed (electric shock). Furthermore, it is slightly larger than the aluminum element 15 to form a pressure-sensitive adhesive layer on the back surface (the surface attached to the body surface) of the peripheral edge of the base tape 14 protruding from the bonded portion with the aluminum element 15; It can be said that it is provided to adhere to the skin (body surface) of humans and animals (mainly mammals such as pets and zoos).

  As a structure of the base tape 14, the insulating base tape main body 14b, which is usually slightly larger than the aluminum element 15 and the conductive gel 17, and the back surface of the base tape main body 14b (attachment to the body surface) Adhesive layer 14c formed on the surface side).

  The base tape main body 14b also has a function (role) as a reinforcing material so that the thin film aluminum element 15 is not easily broken and becomes a wrinkle or bent. Therefore, any material and thickness that can sufficiently exhibit such a function (role) as a reinforcing material may be used.

  The material of the base tape main body 14b is not particularly limited as long as it is insulative and can also function as a reinforcing material for the aluminum element 15, polyethylene (PE), polyethylene terephthalate (PET), Conventionally known materials such as polyurethane can be used. In particular, a material that is highly insulative and flexible, such as polyethylene foam, is a stretchable material having cushioning properties, and can sufficiently function as a reinforcing material for the aluminum element 15 is desirable. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention.

  The thickness of the base tape main body 14b is desirably thin enough to maintain the insulating property and not to be broken, wrinkled or bent, and may be in a range of about 0.5 to 2 μm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  As the material of the adhesive layer 14c, various conventionally known adhesives can be used. For example, natural rubber, acrylic adhesive, urethane adhesive and the like can be exemplified. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention. In particular, an acrylic pressure-sensitive adhesive that has sufficient adhesive force to the aluminum element 15 and the body surface (skin) and can be easily peeled off from the body surface (skin) after use is preferable.

  The thickness of the pressure-sensitive adhesive layer 14c may be in the range of about 5 to 40 μm as long as sufficient adhesive force to the body surface (skin) is obtained. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  The form (shape) of the base tape 14 is not particularly limited, but is generally a rectangular shape having four rounded corners as shown in FIG. However, even if it is other than the form illustrated above, it can be sufficiently applied as long as it does not impair the effects of the present invention.

  The size of the base tape 14 is usually only one size larger than that of the aluminum element 15 and the conductive gel 17, and has four corners having a size of approximately 13 (± 3) cm × 11 (± 3) cm. A rectangular shape rounded is used. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention.

(4) Electrode element 15
The electrode element (aluminum element) 15 is provided to provide an electrical bridge between the cable 16 and the conductive gel 17.

  The electrode element (aluminum element) 15 is formed using an Al alloy that transmits X-rays and has corrosion resistance with respect to the conductive gel 17. By adopting such a configuration, it is possible to obtain a biological electrode that is resistant to corrosion and inexpensive and has X-ray permeability.

(A) First Embodiment of Al Alloy Specifically, an Al alloy containing Mn is used as a first embodiment of an Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17. Specifically, the Al alloy having corrosion resistance with respect to the conductive gel 17 is an Al alloy containing Mn, and the Mn content is 0.1 to 6% by mass, preferably 1 to 4% by mass. It is a range. This is because by containing Mn in the above range in the Al alloy, it can transmit X-rays and impart high corrosion resistance to the conductive gel 17. More specifically, as a first embodiment of an Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17, Mn is contained, and the remainder is an Al alloy composed of Al and impurities, Content is 0.1-6 mass%, Preferably it is the range of 1-4 mass%, At least 1 sort (s) of Mg, Si, Cu, Fe, Zn is contained in the said impurity. More specifically, an Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17 contains Mn, and the balance is an Al alloy composed of Al and impurities, and the content of Mn is 0.1 to 6% by mass, more preferably 1 to 4% by mass, and the impurities include at least one of Mg, Si, Cu, Fe, and Zn, and the impurities Mg, Si, Cu, The contents of Fe and Zn are each 0.03% by mass or less, preferably 0.01% by mass or less, more preferably 0.001% by mass or less. By containing Mn in the above range in the Al alloy and limiting the impurities to the above elements and the content range, X-rays can be transmitted, and while maintaining high corrosion resistance with respect to the conductive gel 17, further forming is performed. This is because the property can be improved.

(B) Second Embodiment of Al Alloy Specifically, an Al alloy containing Mn and Mg is used as a second embodiment of an Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17. Specifically, the Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17 is an Al alloy containing Mn and Mg, and the contents of Mn and Mg are 0.1 to 0.1 respectively. It is 6 mass%, Preferably it is the range of 1-4 mass%. This is because by containing Mn and Mg in the above range in the Al alloy, X-rays can be transmitted and high corrosion resistance can be imparted to the conductive gel 17. More specifically, as a second embodiment of the Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17, it contains Mn and Mg, and the balance is an Al alloy composed of Al and impurities, The contents of Mn and Mg are each 0.1 to 6% by mass, preferably 1 to 4% by mass, and the impurities contain at least one of Si, Cu, Fe and Zn. More specifically, an Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17 contains Mn and Mg, and the balance is an Al alloy composed of Al and impurities, and the Mn and Mg The content of each is in the range of 0.1 to 6% by mass, more preferably 1 to 4% by mass, and the impurity contains at least one of Si, Cu, Fe, and Zn, and the impurities Si and Cu Fe, Zn content is 0.03% by mass or less, preferably 0.01% by mass or less, and more preferably 0.001% by mass or less. By containing Mn and Mg in the above range in the Al alloy and limiting the impurities to the above elements and the content range, X-rays are transmitted and while maintaining high corrosion resistance with respect to the conductive gel 17, This is because the moldability can be further improved.

(A) Al content The Al content (purity) measured according to the method described in JIS H2111 in the Al alloy that transmits X-rays and has corrosion resistance to the conductive gel 17 is the first implementation. In the form, it is sufficient if it is the balance excluding the contents of Mn and impurities, and it is approximately 94 to 99.9% by mass, but it is not necessarily within this range. Similarly, in the second embodiment, it is sufficient if it is the balance excluding the contents of Mn and Mg and impurities, and is approximately 94 to 99.9% by mass, but it is not necessarily within this range.

(B) Mn content Here, Mn transmits X-rays in any of the Al alloys of the first and second embodiments, without reducing the corrosion resistance of the Al alloy with respect to the conductive gel 17, It is an element that can improve elongation, that is, formability. If the Mn content is less than 0.1% by mass, the corrosion resistance of the Al alloy may be reduced with respect to the conductive gel 17. On the other hand, if the Mn content exceeds 6% by mass, the formability deteriorates, and it may be difficult to form an Al alloy thin film. Therefore, it is desirable that the Mn content is in the range of 0.1 to 6% by mass. In order to combine the corrosion resistance and formability (workability) of the Al alloy, it is more preferable that the Mn content is in the range of 1 to 4% by mass.

(C1) Mg content of the first embodiment Next, in the Al alloy of the first embodiment, when Mn is used as an active ingredient, the corrosion resistance of the Al alloy is unexpectedly reduced by containing a very small amount of Mg. It has been found that. Therefore, it is desirable that the Mg content is removed (reduced) to 0.05% by mass or less, preferably 0.01% by mass or less, more preferably 0.001% by mass or less. In addition, as a method for removing (reducing) the content of Mg as an impurity in an Al alloy to 0.05% by mass or less, for example, a high-purity Al metal by a high-grade three-layer electrolytic method may be used as appropriate. . The lower limit of the Mg content is not particularly limited, but is usually about 0.00001% by mass. This is because, in order to make the Mg content less than 0.00001 mass%, it is necessary to repeat the three-layer electrolysis method, and the manufacturing cost is remarkably increased.

(C2) Mg content of the second embodiment Next, in the Al alloy of the second embodiment, by adding a predetermined amount of Mg together with Mn, the strength and formability are improved without deteriorating the corrosion resistance of the Al alloy. It has been found that it can be an element that can be made to occur. If the Mg content is less than 0.1% by mass, the corrosion resistance of the Al alloy may be deteriorated with respect to the conductive gel 17. On the other hand, if the Mg content exceeds 6% by mass, the formability deteriorates, and it may be difficult to form an Al alloy thin film. Therefore, it is desirable that the Mg content is in the range of 0.1 to 6% by mass. By setting the Mg content in the range of 1 to 4% by mass, it is more desirable in that the corrosion resistance, strength, and formability (workability) of the Al alloy can be improved.

(D) Impurity Si content In any of the Al alloys of the first and second embodiments, when the impurity Si is present in the Al alloy, the corrosion resistance of the Al alloy is significantly reduced with respect to the conductive gel 17. In particular, it causes pitting corrosion. Therefore, it is desirable to remove (reduce) the Si content to 0.03% by mass or less, preferably 0.01% by mass or less, and more preferably 0.001% by mass. As for the Si content, the crystal grain size of the Al alloy decreases as the content in the Al alloy decreases. Thereby, the yield strength of the Al alloy, that is, the strength is increased, and the elongation of the Al alloy, that is, the formability can be improved. In order to exhibit these characteristics while maintaining the high corrosion resistance of the Al alloy with respect to the conductive gel 17, the Si content is reduced to 0.001% by mass or less, preferably 0.0005% by mass or less. It is desirable to do this. However, as a characteristic required for the pad electrode 10, strength is not particularly required, and a thin film having a predetermined thickness having corrosion resistance with respect to the conductive gel 17, electrical conductivity (conductivity), and X-ray permeability. Therefore, the characteristics required for the pad electrode 10 can be sufficiently expressed without necessarily reducing the Si content to 0.001% by mass or less. The lower limit of the Si content is not particularly limited, but is usually about 0.00001% by mass. This is because, in order to make the Si content less than 0.00001 mass%, it is necessary to repeat the three-layer electrolysis method, and the manufacturing cost is remarkably increased.

(E) Cu content of impurities In any of the Al alloys of the first and second embodiments, Cu reduces the corrosion resistance of the Al alloy even if it is present in a small amount in the Al alloy. Therefore, it is desirable to remove (reduce) the Cu content to 0.03% by mass or less, preferably 0.01% by mass or less, and more preferably 0.001% by mass. The lower limit of the Cu content is not particularly limited, but is usually about 0.00001% by mass. This is because, in order to make the Cu content less than 0.00001% by mass, it is necessary to repeat the fractional crystallization method, and the manufacturing cost is remarkably increased.

(F) Fe content of impurities In any of the Al alloys of the first and second embodiments, the Fe of impurities forms an intermetallic compound of Al—Fe—Mn together with Mn. The intermetallic compound of Al—Fe—Mn is represented by Al ₆ (Fe, Mn) or the like. Unlike the Al—Mn intermetallic compound Al ₆ Mn, the corrosion resistance of the Al alloy with respect to the conductive gel 17 is increased. It is extremely lowered and causes pitting corrosion and general corrosion. In view of the above, it is desirable to remove (reduce) the impurity Fe content to 0.05% by mass or less, preferably 0.01% by mass or less, more preferably 0.001% by mass or less. When the Fe content exceeds 0.05% by mass, the corrosion resistance is significantly reduced. In addition, as a method for removing (reducing) the content of impurities Fe to 0.05% by mass or less in an Al alloy, for example, a high-purity Al metal by a high-grade three-layer electrolytic method may be used as appropriate. . The lower limit of the content of impurity Fe is not particularly limited, but is usually about 0.00001% by mass. This is because, in order to make the Fe content less than 0.00001 mass%, it is necessary to repeat the three-layer electrolysis method, and the manufacturing cost is remarkably increased.

(G) Zn content of impurities In any of the Al alloys of the first and second embodiments, even if Zn is present in a small amount in the Al alloy, the corrosion resistance of the Al alloy is reduced with respect to the conductive gel 17. Let Therefore, it is desirable that the Zn content of impurities be removed (reduced) to 0.05% by mass or less, preferably 0.01% by mass or less, more preferably 0.001% by mass or less. In addition, as a method of removing (reducing) the content of Zn as an impurity in an Al alloy to 0.05% by mass or less, for example, a high-purity Al ingot by a high-grade three-layer electrolytic method may be used as appropriate. . The lower limit of the Zn content is not particularly limited, but is usually about 0.00001% by mass. This is because, in order to make the Zn content less than 0.00001 mass%, it is necessary to repeat the three-layer electrolysis method and the like, and the manufacturing cost is remarkably increased.

(H) Other elements contained in Al alloy In any of the Al alloys of the first and second embodiments, the Al alloy has the effects of the present invention, the corrosion resistance against the conductive gel 17, and the electrical conductivity (conductivity). And transition elements such as V (vanadium), Ti (titanium), Zr (zirconium), Cr (chromium), Ni (nickel), etc., as long as the content is within the range not affecting the X-ray permeability. , B (boron), Ga (gallium), Bi (bismuth) and the like may be included.

  As described above, in any of the Al alloys according to the first and second embodiments, the optimum amount of the above-described additive elements is added to the Al alloy (and the amount of impurities is further reduced), so that the Al alloy can be recycled. The crystal structure can be made ultrafine. Thereby, the corrosion resistance and formability of the Al alloy can be improved at the same time. That is, in the Al alloy of the first embodiment, the content of the additive element Mn is optimized. In the Al alloy of the second embodiment, the contents of the additive element Mn and Mg are optimized. By reducing the content of elements that greatly reduce the corrosion resistance to the conductive gel 17, the conductive gel is used for a predetermined period (product warranty period; for example, usually 24 months for a defibrillator). It is excellent in corrosion resistance that can prevent the progression of pitting corrosion and overall corrosion due to 17.

  The aluminum element 15 is a thin film having a thickness of 9 to 200 μm formed using an Al alloy having corrosion resistance, electrical conductivity (conductivity), and X-ray permeability with respect to the conductive gel 17. As the thin film having such a thickness, an Al alloy foil or button type thin film formed by a rolling method or the like can be used.

  The form (shape) of the aluminum element 15 is not particularly limited, but a rectangular shape having four rounded corners as shown in FIG. 1 is generally used. However, even if it is other than the form illustrated above, it can be sufficiently applied as long as it does not impair the effects of the present invention.

  The size of the aluminum element 15 is usually a size that is slightly smaller than the base tape 14 and the conductive gel 17, and has four corners with a size of approximately 10 (± 3) cm × 9 (± 3) cm. A rectangular shape rounded is used. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention.

  Although not shown in FIG. 1, a polyethylene terephthalate (PET) sheet is provided on the base tape 14 side as a backing material (reinforcing material) 15b of the aluminum element 15 in order to make the thin and easily broken aluminum element 15 difficult to break. It is desirable to use a laminated polyethylene or PE sheet. The backing material (reinforcing material) 15b is not particularly limited, and various types of conventionally known resin sheets can be used, and materials other than those exemplified above can be used. The present invention is sufficiently applicable as long as the effects are not impaired.

  As the thickness of the backing material (reinforcing material) 15b, it is sufficient that the aluminum element 15 which is thin and easily torn can be made difficult to break. From the viewpoint of reducing the weight of the pad electrode 10, it is preferable that the thickness is thin. It is.

  The backing material (reinforcing material) 15 b is also provided with an adhesive layer (not shown) on the adhesive surface with the aluminum element 15. The adhesive layer is not particularly limited, and various conventionally known adhesives can be used. For example, natural rubber, acrylic adhesive, urethane adhesive and the like can be exemplified. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention.

(5) Cable 16
FIG. 2 is a schematic diagram illustrating a state in which the pad electrode 10 is mounted on the patient.

  As shown in FIGS. 1 and 2, the cable 16 connects (electrically connects) the defibrillator body 20 and the pad electrode 10 (specifically, the aluminum element 15) attached to the patient 21. . As shown in FIG. 1, the cable 16 has a cable body (lead wire) 16a, and a fastener having a through hole 16c at one end portion of the cable body 16c electrically connected to the pad electrode 10. 16b is provided, and is fixed together with the aluminum element 15 and the base tape 14 by the rivet 12 and the ring washers 13a and 13b. Furthermore, as shown in FIG. 2, the other tip portion of the cable 16 is normally electrically connected to the defibrillator body 20 in the following two forms.

  That is, the other tip of the cable body 16a may be directly connected to (i) the defibrillator body or (ii) connected to the defibrillator body 20 as shown in FIG. A connector 23b that can be connected to a connector 23a provided at the tip of another cable (lead wire) 22 may be provided. For example, as an automatic external defibrillator (AED), in addition to being used in hospitals and ambulances outdoors, general users may use it as an operator in addition to doctors and paramedics. In view of the above, the form (i) integrated with the defibrillator body is desirable. Also, operators (mainly doctors and paramedics) in hospitals and ambulances like external defibrillators (including semi-automatic defibrillators and automatic external defibrillators (AEDs)) When used for many patients, the defibrillator main body is not changed, and only the disposable pad electrode (pad) 10 can be exchanged for each patient. Is desirable. In this case, the use of the disposable pad electrode 10 eliminates the need for the operator to hold the pad electrode 10 and is excellent in preventing hospital infections.

  The cable body 16c is not particularly limited, and a conventionally known cable body can be used. For example, a conventionally known one can be used such as a carbon wire, a tin-plated Cu wire, an Al wire or the like coated with an insulating material.

  The material of the fastener 16b may be a conductive material, and for example, brass, Al or the like can be used.

  Further, the connector 23b on the cable 16 side is particularly limited as long as it can be connected to the connector 23a provided at the end of another cable (lead wire) 22 connected to the defibrillator body 20. A conventionally well-known thing can be used instead of a thing.

(6) Conductive gel 17
The conductive gel 17 is provided to adhere to the skin of a human or animal and to be electrically connected. As the conductive gel 17, a gel that contains water and can flow electricity (has conductivity) is generally used. As the conductive gel 17, a self-adhesive conductive gel having skin compatibility is preferably used.

  Such a conductive gel 17 is not particularly limited, and various conventionally known self-adhesive conductive gels having various skin compatibility can be suitably used. For example, a combination of a crosslinked copolymer of an alkoxy polyethylene glycol mono (meth) acrylate with an unsaturated carboxylic acid such as acrylic acid, which may be partially neutralized, polyethylene glycol monoalkyl ether and water. It is found that the gel made of the above exhibits stable self-adhesiveness in a wide humidity range, and the following pressure-sensitive adhesive composition disclosed in JP-A-2002-356661 already proposed can be used. Specifically, the following general formula (1)

A compound represented by the formula (wherein R ₁ represents hydrogen or a methyl group, R ₂ represents a methyl group or an ethyl group, and n represents an integer of 2 to 12) or a mixture thereof, partially A cross-linked copolymer containing an unsaturated carboxylic acid monomer which may be neutralized, and a general formula (2)

Or a mixture thereof (wherein R ₃ represents a methyl or ethyl group, m represents an integer of 8 to 30) and a pressure-sensitive adhesive composition comprising a gel composed of water and an electrolyte. Conductive gel. As a compound of the said General formula (1), what is a mixture of n = 4 on the average is desirable. The unsaturated carboxylic acid is preferably acrylic acid. Further, in order to use as the conductive gel 17, in the above-mentioned adhesive composition, an alkali metal halide (alkali halide) such as lithium chloride, sodium chloride, potassium chloride or the like is used as an electrolyte in order to make the composition conductive. ) Is contained. In order to adjust the hygroscopicity, it is desirable to add a polyhydric alcohol such as glycerin or propylene glycol or a moisturizing component such as lactic acid, urea or hyaluronic acid in addition to the alkoxy polyethylene glycol. In addition, fragrances, colorants, medicinal ingredients and the like can be added. Moreover, as a manufacturing method of this adhesive composition,
(A) The following general formula (1)

A compound represented by the formula: wherein R ₁ represents hydrogen or a methyl group, R ₂ represents a methyl group or an ethyl group, and n represents an integer of 2 to 12, and (b) an unsaturated carboxylic acid Acid monomers,
(C) a polyfunctional unsaturated organic compound containing a plurality of radically polymerizable groups, and (d) an alkali compound. (E) General formula (2)

(Wherein R ₃ represents a methyl or ethyl group, m represents an integer of 8 to 30), and (f) water. The compound of the general formula (1) is maintained by maintaining the compound of the general formula (1) and the compound of the general formula (2) in the coexistence conditions of the alkali compound when preparing the raw material mixture to be cross-linked and copolymerized in the production method of the pressure-sensitive adhesive composition. What reduced the content of the impurity which is a polyfunctional compound contained in it, and reduced the influence by the impurity content on the performance of the adhesive which produces | generates is desirable. In addition to the above, water, a polymerization inhibitor, a polymerizable monomer (for example, a compound of the above general formulas (1) and (2)), a pH adjuster using an amino alcohol also serving as a conductive substance, and a crosslinking agent are mixed. An example is an adhesive conductive gel obtained by adding a polymerization initiator and performing a polymerization reaction to adjust the pH to 8 to 13. The reason for using aminoalcohol as the pH adjuster is, for example, if caustic soda is used as the pH adjuster, the conductive gel 17 is electrolyzed with sodium ions and subjected to hydrolysis, resulting in a pH in the vicinity of the aluminum element 15. This is because the amino alcohol does not undergo hydrolysis and thus does not cause a change in pH. The potential of the aluminum element 15 is more stable when the conductive gel 17 is alkaline than acidic. For this reason, it is desirable that the conductive gel 17 has a pH of 8 or higher and a pH of 13 or lower in consideration of the influence on the skin. Further, as the self-adhesive conductive gel 17 having skin compatibility, a commercially available one may be used. For example, RG-, commercially available from Kendall-LTP division of Tyco Healthcare Group LD, Mansfield, Massachusetts. 63B conductive hydrogels, conductive gels manufactured by the LecTec Corporation of minnetonka, Mim., Can also be used (gels disclosed in US Pat. No. 4,979,517). However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention.

  The method for attaching the conductive gel 17 to the base tape 14 and the aluminum element 15 is not particularly limited. For example, the aluminum element 15 after fixing the base tape 14, the aluminum element 15, and the cable 16. The conductive gel 17 (or a precursor composition thereof) may be applied and formed (or polymerized) on the base tape 14 (which may further include a part of the base tape 14). Alternatively, the conductive gel 17 formed on the releasable film is made of the aluminum element 15 after fixing the base tape 14, the aluminum element 15, and the cable 16 (further, a part of the base tape 14 may be included). ) It may be overlaid and pasted, and the release film may be peeled off. However, methods other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention.

  As for the thickness of the conductive gel 17, the adhesiveness to the body surface (skin) is sufficient, and the electrical conductivity is sufficient to allow the energization necessary for the body surface (skin) from the cable 16 and the aluminum element 15 through the conductive gel 17. As long as it is approximately 0.5 to 2 mm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  The shape (form) of the conductive gel 17 is not particularly limited, but a shape having a rectangular shape with four rounded corners as shown in FIG. 1 is generally used. However, as shown in FIG. 1, the conductive gel 17 has a rectangular shape that is slightly larger than the portion corresponding to the position of the fastener 16b so as not to directly contact the fastener 16b at the tip portion of the cable 16. The end portion on the short side is cut into a U-shaped (concave) shape. However, even shapes other than those exemplified above are adequately applicable as long as they do not impair the operational effects of the present invention.

  The size of the conductive gel 17 (the size of the rectangular portion with rounded corners) may be one size smaller than the base tape 14 and one size larger than the aluminum element 15. A size of about 11 (± 3) cm × 10 (± 3) cm is used. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention. The size of the shape of the conductive gel 17 in which the end portion on the short side of the rectangular shape is cut into a U-shape (concave) may be a size that is slightly larger than the fastener 16b, and is approximately 5 (± 1) The size may be about cm × 3 (± 1) cm. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention.

(7) Cover tape 18
The cover tape 18 is provided to prevent the aluminum element 15 and the cable 16 from directly touching human or animal skin (body surface). That is, most of the surface side of the aluminum element 15 (the side opposite to the surface attached to the surface) is covered with the conductive gel 17 and has a structure that does not directly touch human or animal skin (body surface). Has been. However, as shown in FIG. 1, the end portion on the short side of the rectangular shape of the conductive gel 17 has a shape cut out into a U-shaped (concave) shape, and is a conductor located in this portion. The fastener 16b at the tip of the aluminum element 15 and the cable 16 directly touches the skin (body surface) of a human or animal (a large current flows through the body surface through a small area of the conductor = the skin that contacts the conductor burns) It may cause burns). Therefore, a cover tape 18 is provided so that the conductive gel 17 covers (covers) the portion of the U-shaped (concave) cut out with an insulating material, and the insulating material can adhere to the body surface. Is.

  As the structure of the cover tape 18, an insulating cover tape base material 18a, which is one size larger than a portion where the conductive gel 17 is cut out in a U-shaped (concave) shape, and the cover tape base material 18a The adhesive layer 18b formed on the front surface (the adhesive surface side with the base tape main body 14b) and the adhesive layer 18b formed on the back surface (the adhesive surface side to the body surface) of the cover tape base material 18a It is.

  The cover tape base material 18a only needs to have an insulating function (role) that prevents the aluminum element 15 and the cable 16 that are conductors from directly touching the skin (body surface) of a person or an animal to receive an electric shock. Therefore, any material and thickness that can sufficiently exhibit such an insulating function (role) may be used.

  The material of the cover tape substrate 18a is not particularly limited as long as it can function as an insulating material, and conventionally known materials such as polyethylene (PE) and polyethylene terephthalate (PET) can be used. In particular, in order to allow the entire surface of the self-adhesive conductive gel 17 to be in close contact (adhesion) with the skin (body surface), as with the base tape main body 14b, insulation such as polyethylene foam is high. It is desirable to be made of a stretchable material having flexibility and cushioning properties. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention.

  The thickness of the cover tape substrate 18a is also such that it retains insulation, has flexibility (cushioning property), is stretchable, and can adhere to the entire surface of the skin (body surface). It is desirable that the thickness be in the range of 0.5 to 2 mm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  Although it does not restrict | limit especially as a material of the contact bonding layer 18b, Various conventionally well-known adhesives can be utilized, such as the adhesive agent similar to the contact bonding layer 11b being used. For example, natural rubber, acrylic adhesive, urethane adhesive and the like can be exemplified. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention. An acrylic pressure-sensitive adhesive that can firmly bond between the cover tape base material 18a and the base tape main body 14b (both between insulating resin materials, particularly between polyethylene foams) is preferable.

  The thickness of the adhesive layer 18b is sufficient as long as sufficient adhesive force can be exerted between the cover tape base material 18a and the base tape main body 14b (both between insulating resin materials, particularly between polyethylene foams), and is generally 0.5 to It may be in the range of 40 μm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  Although it does not restrict | limit especially as a material of the adhesion layer 18c, It is desirable to use the adhesive similar to the adhesion layer 14c, and conventionally well-known various adhesives can be utilized. For example, natural rubber, acrylic adhesive, urethane adhesive and the like can be exemplified. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention. An acrylic pressure-sensitive adhesive that has sufficient adhesion to the body surface (skin) and can be easily peeled off from the body surface (skin) after use is preferred. The adhesive 18b and the adhesive 18c are sufficiently stronger in adhesion to the base tape main body 14b by the adhesive 18b than the adhesive force to the body surface (skin) by the adhesive 18c. When peeling from (skin), it is necessary to select one that does not peel off the adhesive surface between the base tape main body 14b and the cover tape base 18a.

  The thickness of the pressure-sensitive adhesive layer 18c is sufficient as long as sufficient adhesive force to the body surface (skin) is obtained, and may be in a range of approximately 0.5 to 40 μm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  The form (shape) of the cover tape 18 is not particularly limited, but as shown in FIG. 1, three corners that are slightly larger than the portion where the conductive gel 17 is cut out in a U-shaped (concave) shape. A saddle shape (triangle shape or rice ball shape) rounded is generally used. However, even if it is other than the form illustrated above, it can be sufficiently applied as long as it does not impair the effects of the present invention.

  The size of the cover tape 18 may be any size that is one size larger than the portion where the conductive gel 17 is cut out in a U-shaped (concave) shape, and generally has a base 8 (± 1) cm × high. A saddle shape having three rounded corners with a size of about 4 (± 1) cm is used. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention.

(8) Release sheet 19
The release sheet 19 is provided to protect the adhesive surface before use. On the adhesive surface before use, the self-adhesive conductive gel 17 (entire surface), the adhesive surface of the base tape 14 on the outer peripheral portion thereof, and the conductive gel 17 are cut into a U-shaped (concave) shape. The adhesive surface of the provided cover tape 18 (that is, the adhesive layer 14c, the self-adhesive conductive gel 17 and the adhesive layer 18c) is included.

  As a material of the release sheet 19, oxygen molecules and water molecules are hardly transmitted through the release sheet 19 so that the adhesive face can be prevented from being deteriorated during storage in order to protect the adhesive face before use. , Before use, as long as it has flexibility so that it can be closely adhered to the adhesive surface and can be easily peeled off immediately before use, various conventionally known release sheet materials should be used. Can do. For example, polyethylene (PE), polyethylene terephthalate (PET), paper, etc. can be illustrated. However, materials other than those exemplified above can be sufficiently applied as long as they do not impair the effects of the present invention.

  The thickness of the release sheet 19 is not particularly limited, but may be in a range of approximately 10 to 125 μm. However, even if it is outside the above range, it is sufficiently applicable as long as it is within a range that does not impair the effects of the present invention.

  The form (shape) of the release sheet 19 is not particularly limited, but as shown in FIG. 1, the self-adhesive conductive gel 17 (entire surface), and the adhesive surface of the base tape 14 on the outer periphery thereof. The adhesive surface (that is, the adhesive layer 14c, the self-adhesive conductive gel 17 and the back adhesive layer 18c) of the cover tape 18 provided at the portion where the conductive gel 17 is cut out in a U-shaped (concave) shape. In order to be able to cover, basically, it may be a rectangular shape in which the four corners of the same shape as the base tape 14 are rounded, but the portion 19a that protrudes from the base tape 14 is easily removed so that it can be easily removed. It is desirable to have. However, even if it is other than the form illustrated above, it can be sufficiently applied as long as it does not impair the effects of the present invention.

  The release sheet 19 may be basically the same size as the base tape 14, and the four corners with a size of about 13 (± 3) cm × 11 (± 3) cm are rounded. A rectangular shape is used. In addition, when it has the protrusion part 19a from the base-material tape 14 so that it can peel easily as a part of peeling sheet 19, the magnitude | size is a size of about 1 (+/- 1) cm x 3 (+/- 1) cm in general. If so, it is easy to grasp when peeling. However, even sizes other than those exemplified above are adequately applicable as long as they do not impair the effects of the present invention.

  The above is used for various defibrillators (for example, an external defibrillator, a semi-automatic defibrillator, an automatic external defibrillator (AED), etc.) as an embodiment of the biomedical electrode of the present invention. However, the biomedical electrode of the present invention is not limited to these, and various defibrillators (for example, defibrillation with a pacing function in addition to a defibrillation function) It can be used as a transdermal pacing electrode used for a motive device, etc .; an electrocardiogram electrode; a biological electrode having X-ray permeability that can be used for a counter electrode and the like. Among these, a defibrillation electrode, a percutaneous pacing electrode, and an electrocardiogram electrode can be used in common, and the above-mentioned defibrillation electrode (disposable pad electrode) can be used. Furthermore, the biological electrode of the present invention can be used as a multifunction electrode in which a defibrillation electrode, a percutaneous pacing electrode, and an electrocardiogram electrode are used as one electrode. In this case, it is necessary to use a conductive gel containing chloride ions (for example, lithium chloride, sodium chloride, potassium chloride, etc.). This is because percutaneous pacing cannot be performed if there is a passive film on the surface of the aluminum element. However, by containing chloride ions, the passive film can be destroyed, and transcutaneous pacing for 60 minutes or more is possible. Is something that can be done. On the other hand, when a conductive gel containing no chloride ions is used, pacing cannot be performed in about 5 minutes.

  A defibrillator used by a doctor in a hospital has various functions in addition to a defibrillation function, and is called a defibrillator with a pacing function, a manual defibrillator, or the like. As an electrode used for such a defibrillator, there are a defibrillation electrode (disposable pad electrode), a percutaneous pacing electrode, and an electrocardiogram electrode. Of these, the defibrillation electrode (disposable pad electrode) is as described above.

  The transcutaneous pacing electrode is used for the surface of the body, usually the left flank, until the pacemaker is prepared at the time of extreme bradycardia in a hospital or the like. It is affixed to the chest (usually the right chest for adult men and the center of the chest for children and women), and a current of about 100 mA is applied from there to use it to force the heart to contract.

  The above-mentioned electrocardiogram electrode is a defibrillator equipped with an electrocardiogram analysis function in a hospital, an ambulance or outdoors, and an electrocardiogram electrode (usually the same configuration as the disposable pad electrode 10) is placed on the left flank and chest of the patient. When the device is attached and the analysis button of the defibrillator is pressed, the electrocardiogram analysis device in the defibrillator analyzes the electrocardiogram. If the device determines that defibrillation is necessary, it notifies the operator by sound or voice. A doctor or paramedic) is used to defibrillate by depressing a shock button to energize.

  The said counter electrode plate is an electrode used for one side of an electric knife (electrosurgical device). Specifically, during surgical operation with an electric knife, it is mounted with a relatively wide contact area called a counter electrode (mainly on the back of the patient, such as the patient's flank or back). (Generally, the same configuration as the disposable pad electrode 10 may be used, provided that the external device is not a defibrillator but a high-frequency power source), and a metal electrode called a female tip electrode (active electrode, active electrode) As a pair, high-frequency current is passed through the living body. As a result, no heat is generated on the counter electrode side where the contact resistance is low and the current density is low, and on the other hand, heat is generated by Joule heat or arc discharge on the female tip electrode side having a certain degree of contact resistance and high current density. This heat instantly heats the cells, explodes and dissipates, and causes incision and coagulation. Thus, the counter electrode is another external defibrillation electrode; a percutaneous pacing electrode; an electrocardiogram in that it is attached to the body surface during surgery using an electric scalpel (electrosurgical device). It is the same as the electrode for the use. However, as described above, the size of the electrode is generally larger than that of the other electrodes for the counter electrode.

  FIG. 3A is a schematic view schematically showing a counter electrode used for one of the electric scalpels as one embodiment of the biomedical electrode of the present invention. 3B is a cross-sectional view taken along line AA in FIG. 3A. As shown in FIGS. 3A and 3B, the counter electrode 30 is configured such that a pair of symmetrical electrode elements (aluminum elements) 15 are provided on the base tape 14, and a part of each is based on the base electrode 14. It is formed so as to protrude from the material tape 14. A conductive gel 17 is formed on the electrode element (aluminum element) 15 (here, the conductive gel 17 is provided so as not to protrude from the electrode element (aluminum element) 15). Each of the electrode elements (aluminum elements) 15 protruding from the base tape 14 has a clip 16d provided at the tip of the cable 16 and is electrically connected. The other end of the cable 16 is electrically connected to a high-frequency power source (not shown, see FIG. 2), which is an external device, directly or via a connector. Here, the clip 16d only needs to be electrically conductive (conductor), and is not particularly limited. For example, SUS, Al, or the like can be used. Before use, it is desirable that a release sheet 19 (not shown) is provided on the conductive gel 17 for the purpose of preventing drying. Further, the electrode element (aluminum element) 15 in the portion protruding from the base tape 14 may be provided with a backing material (reinforcing material) 15b (not shown), or for the electrode in the protruding portion. Only the portion of the element (aluminum element) 15 may be thickened to have strength.

  The biomedical electrode of the present invention has the following characteristics.

  (1) It has the following advantages compared with the biomedical electrode which uses the existing tin for an electrode element.

(A) X-ray transmission type. Since conventional biomedical electrodes using tin do not transmit X-rays, when performing X-ray imaging of a catheter room or the like, it is necessary to perform X-ray imaging after removing the biological electrode attached to the patient once. there were. Therefore, during examinations (treatment, medical treatment, medical examination, diagnosis) such as X-ray CT in the catheter room, the patient's electrocardiogram monitor, ventricular fibrillation waveform monitor, SpO ₂ , ETCO ₂ etc. Could not be monitored. On the other hand, the living body electrode having X-ray transmission ability according to the present invention does not interfere with X-ray transmission even when the living body electrode is attached to the patient (the state of the heart can be monitored). X-ray imaging can be performed. During this period, the patient's electrocardiogram monitor, ventricular fibrillation waveform monitor, and SpO ₂ , ETCO _2, etc. can also be monitored. Furthermore, even when a pacemaker is implanted, a living body electrode having X-ray transmission ability is excellent in that it can be attached in advance and an operation can be performed while monitoring the state of the heart with X-rays.

    (B) It is not necessary to take measures against discoloration of the conductive gel by tin oxide. Therefore, an oxygen scavenger (for example, Ageless (registered trademark)) does not have to be included in order to prevent discoloration due to oxygen transmitted through the packing (packaging) material. In addition, the cable does not have to be sealed in order to prevent the cable from being affected by the tin oxide added to the conductive gel (oxygen flows into the covering material).

  (2) The following advantages are obtained as compared with a biomedical electrode using a sheet (carbon sheet) in which carbon fiber is kneaded into an existing resin.

    (A) The carbon element used for the electrode element has a problem of being expensive and costly. In the case of using the aluminum element 15 of the present invention, there is an advantage that it can be made extremely cheaper than the carbon element.

    (B) The carbon sheet alone does not produce performance as a biological electrode such as a defibrillator (= electric performance cannot be maintained for 24 months), so many silver silver chloride and manganese dioxide are applied, There was another problem of higher costs. In addition, there are very few conductive gels that can be used for carbon elements, and they are vulnerable to drying. After 24 months, which is the normal warranty period, there are plenty of cloud points (parts that have been dried). Silver silver chloride or manganese dioxide and the conductive gel reacted, or the conductive gel dissolved and deteriorated, so that the electrode performance could not be exhibited sufficiently. In the case of using the aluminum element 15 of the present invention, it is not necessary to apply silver silver chloride or manganese dioxide, and it can be made more inexpensive, and there are no restrictions on the conductive gel that can be used. Since it can be arbitrarily selected from among those that are resistant to drying, even after 24 months, which is the normal warranty period, there is no muddy point (the part that has been dried), and sufficient electrode performance There is an advantage that can be expressed.

  (3) The following advantages are obtained as compared with a biological electrode using an Al foil as an electrode element.

    (A) Since the Al foil as the electrode element corrodes due to contact with the conductive gel which is one of the constituent members of the biological electrode, there is a problem that it cannot be used practically. For example, when used as a transcutaneous pacing electrode, it is usually necessary to withstand a load of about 60 minutes. However, since gas is generated on the surface of the passive film, it does not have 5 minutes. On the other hand, when the aluminum element 15 of the present invention is used, the aluminum element which is an electrode element is not easily corroded by contact with the conductive gel, and the corrosion is not a cloud point even after 24 months, which is the storage period of the product. Is not recognized, and there is an advantage that no discoloration of the conductive gel is recognized. Furthermore, even when used as a transdermal pacing electrode, there is an advantage that it can withstand a load of 60 minutes or more.

Example 1
The following experiment was conducted using the disposable pad electrode 10 having the configuration shown in FIG.

  Here, as a component of the pad electrode 10, the label 11 has a circular shape with a diameter of 3 cm using a synthetic paper having a thickness of 110 μm for the sheet substrate 11 a and an acrylic adhesive having a thickness of 30 μm for the adhesive layer 11 b. A thing was used.

  The rivet 12 was caulked using SUS430 having a diameter of 3 mm.

  As the ring washers 13a and 13b, SUS304 having an inner diameter of 3.2 mm and an outer diameter of 11 mm was used.

  For the base tape 14, a polyethylene foam having a thickness of 1 mm was used for the base tape main body 14b, and an acrylic adhesive having a thickness of 30 μm was used for the adhesive layer 14c.

  The aluminum element 15 contains Mn, and the balance is an Al alloy composed of Al and impurities, and the impurities are Mg, Si, Cu, Fe, and Zn. The name Arnoble ZR-N)) was used.

  The cable 16 is a cable body 16c covered with a tin-plated Cu wire, brass is used for the fastener 16b having a through hole 16c at the tip portion, and the other tip portion is an external device (defibrillation). (Motor body) 20.

  For the cover tape 18, a 1 mm thick polyethylene foam was used for the cover tape substrate 18 a, a 30 μm thick acrylic adhesive was used for the surface adhesive layer 18 b, and a 30 μm thick acrylic adhesive was used for the back adhesive layer 18 b.

  For the release sheet 19, polyethylene terephthalate (PET) having a thickness of 75 μm was used.

  The assembly of the pad electrode 10 was performed by first bonding the base tape 14 and the aluminum element 15 with the positions of the through holes 14a and 15a overlapped using the above-described components. Next, ring washers 13a and 13b are attached to both sides of the through-holes 14a and 15a, and the fastener 16b of the cable 16 is inserted. (Casting) These were fixed. The label 11 was affixed so that the rivet 12 and the ring washer 13a were not exposed. Next, a self-adhesive conductive gel 17 was applied to the surface of the aluminum element 15 (including the base tape 14 on the outer peripheral portion of the aluminum element 15) so as to have a predetermined thickness. At this time, as shown in FIG. 1, the conductive gel 17 is applied to the fastener 16 so that the conductive gel 17 does not adhere to the fastener 16, and then the conductive gel 17 is applied. The cover tape 18 was affixed to. Finally, a release sheet 19 was attached to the surface of the conductive gel 17 (including the cover tape 18) to complete the assembly (production) of the pad electrode 10.

(Example 2)
As the aluminum element 15, instead of the Al alloy thin film of Example 1, Al alloy thin film containing Mn, the balance being Al alloy composed of Al and impurities, and the impurities being Mg, Si, Cu, Fe and Zn A pad electrode 10 was produced in the same manner as in Example 1 except that (aluminum foil manufactured by Toyo Aluminum Co., Ltd. (trade name Alnoble ZR-S)) was used.

(Comparative Example 1)
A pad electrode 10 was produced in the same manner as in Example 1 except that instead of the aluminum element 15, an electrode element using a 75 μm thick tin foil was used and a conductive gel containing tin chloride was used.

(Comparative Example 2)
A pad electrode 10 was produced in the same manner as in Example 1 except that an electrode element in which silver silver chloride was applied to a carbon sheet having a thickness of 100 μm was used instead of the aluminum element 15.

(Comparative Example 3)
A pad electrode 10 was produced in the same manner as in Example 1 except that an Al foil (purity 99.5%) was used in place of the aluminum element 15.

<Test content>
(1) X-ray permeability test Using the pad electrode 10 produced in each Example and Comparative Example, X-ray imaging was performed in a catheter room, and X-ray permeability was confirmed.

  As a result of the above test, it was confirmed that the samples of Examples 1 to 3 transmitted X-rays except for a fixing member and a cable using a metal material. On the other hand, in Comparative Example 1, since tin was used for the electrode element, it was confirmed that X-rays were not transmitted (the electrode part was photographed in all white). Even in the samples of Comparative Examples 2 and 3, it was confirmed that X-rays were transmitted except for a fixing member and a cable using a metal material.

(2) High temperature test (acceleration life test)
The electrode element produced by holding the pad electrode 10 produced in each example and comparative example at a high temperature (50 ° C.) for 3 months (according to the state of being stored at room temperature for 24 months as the acceleration life) The state of was observed.

  As a result of the above test, no change was observed in the samples of Examples 1 to 3. On the other hand, in Comparative Example 1, tin was rusted (corroded), and gel discoloration was also observed. In Comparative Example 2, a few conductive gels that can be used for the carbon element were used, but the conductive gels were vulnerable to drying, and a large number of turbid points were observed after the high temperature test. Also in Comparative Example 3, after the high temperature test, many corrosions due to dissolution of the Al foil were observed.

(3) Performance Test of Defibrillation Electrode After the high temperature test of (2) above, it was confirmed whether or not it sufficiently functions as a defibrillation electrode using the pad electrode 10 produced in Examples and Comparative Examples.

  As a result of the above test, in the samples of Examples 1 to 3, it was confirmed that the pad electrode 10 was attached to the surface of the dummy doll and energized from the defibrillator, so that the pad electrode 10 was sufficiently satisfied. did it. Moreover, since no high concentration of salt was used for the conductive gel 17, no problem of cytotoxicity occurred. On the other hand, Comparative Examples 1 to 3 could not function sufficiently as a defibrillation electrode.

(Discussion)
In Comparative Example 2, the carbon element used for the electrode element has a problem of being expensive and costly. Furthermore, since carbon alone does not provide performance as a defibrillation electrode, it is more costly to apply silver-silver chloride. In addition, there are very few conductive gels that can be used for carbon elements, and they can be dried. It is weak, and after high temperature test (acceleration life test), it is full of turbidity (the part that has been dried), silver silver chloride or manganese dioxide reacts with conductive gel, or conductive gel dissolves, etc. As a result, the electrode performance was not fully exhibited.

  In Comparative Example 3, it was confirmed that the Al foil as the electrode element was corroded, so that it could not be used practically.

10 Disposable pad electrodes (disposable electrodes) that are one type of biological electrodes,
11 labels,
11a sheet base material,
11b adhesive layer,
12 rivets,
13a, 13b ring washers,
14 base tape,
14a through hole for rivets,
14b base tape body,
14c adhesive layer,
15 Electrode element (aluminum element),
15a through hole,
15b backing material (reinforcing material),
16 cables,
16a cable body,
16b fasteners,
16c through hole,
16d clip,
17 conductive gel,
18 Cover tape,
18a Cover tape base material,
18b adhesive layer,
18c adhesive layer 19 release sheet,
19a The protruding part,
20 Defibrillator body which is an external device,
21 patients,
22 Another cable connected to the defibrillator body,
23a Connector at the tip of the cable of the defibrillator body,
23b, connector at the tip of the disposable pad electrode cable,
30 Counter electrode.

Claims (12)

A conductive gel;
An electrode element;
In the biomedical electrode, including a cable for electrically connecting the biomedical electrode and an external device,
The electrode for a living body, wherein the electrode element is a thin film formed using an Al alloy that transmits X-rays and has corrosion resistance to a conductive gel.   The biomedical electrode according to claim 1, wherein the Al alloy is an Al alloy containing Mn.   The biomedical electrode according to claim 1 or 2, wherein the Al alloy is an Al alloy containing Mn, and the Mn content is in the range of 0.1 to 6% by mass. The Al alloy contains Mn and the balance is an Al alloy composed of Al and impurities, and the impurities include at least one of Mg, Si, Cu, Fe, and Zn,
The biological electrode according to any one of claims 1 to 3, wherein the Mn content is in the range of 0.1 to 6 mass%. The Al alloy contains Mn, and the balance is Al alloy composed of Al and impurities,
The Mn content is in the range of 0.1 to 6% by mass,
The impurity contains at least one of Mg, Si, Cu, Fe, Zn,
Content of Mg, Si, Cu, Fe, Zn in the said impurity is 0.03 mass% or less, respectively, The electrode for biological bodies of any one of Claims 1-4 characterized by the above-mentioned. The Al alloy contains Mn, and the balance is Al alloy composed of Al and impurities,
The Mn content is in the range of 0.1 to 6% by mass,
Mg, Si, Cu, Fe and Zn are included in the impurities,
The bioelectrode according to any one of claims 1 to 5, wherein the contents of Mg, Si, Cu, Fe, and Zn in the impurity are all 0.03% by mass or less.
The biomedical electrode according to claim 1, wherein the Al alloy is an Al alloy containing Mn.   The said Al alloy is Al alloy containing Mn and Mg, Comprising: Content of Mn and Mg is the range of 0.1-6 mass%, respectively, The any one of Claims 1-3 characterized by the above-mentioned. The biological electrode according to Item 1. The Al alloy contains Mn and Mg, the balance is an Al alloy composed of Al and impurities, and the impurities have at least one of Si, Cu, Fe, and Zn,
The bioelectrode according to any one of claims 1 to 3, wherein the contents of Mn and Mg are in the range of 0.1 to 6% by mass, respectively. The Al alloy contains Mn and Mg, and the balance is Al alloy composed of Al and impurities,
The contents of Mn and Mg are in the range of 0.1 to 6% by mass,
The impurity contains at least one of Si, Cu, Fe, Zn,
Content of Si, Cu, Fe, Zn in the said impurity is 0.03 mass% or less, respectively, The bioelectrode of any one of Claims 1-3, 7-8 characterized by the above-mentioned. . The Al alloy contains Mn and Mg, and the balance is Al alloy composed of Al and impurities,
The contents of Mn and Mg are in the range of 0.1 to 6% by mass,
Si, Cu, Fe and Zn are included in the impurities,
The bioelectrode according to any one of claims 1 to 5, wherein the contents of Si, Cu, Fe, and Zn in the impurities are all 0.03% by mass or less.   11. The biological electrode according to claim 1, wherein the electrode element is a thin film having a thickness of 9 to 200 μm formed using the Al alloy.   The biomedical electrode is a defibrillation electrode, a percutaneous pacing electrode, an electrocardiogram electrode, a multi-function electrode or a counter electrode having a defibrillation function, a percutaneous pacing function, and an electrocardiogram monitor function as one electrode. Item 12. The biological electrode according to any one of Items 1 to 11.