Percutaneous electrification patch

Abstract

To provide a percutaneous electrification patch capable of enhancing an improving operation of a target portion of a subject.SOLUTION: A percutaneous electrification patch 1 comprises: an electrode 10 having an anode electrode 11 and a cathode electrode 12; and conductive parts 20A and 20B disposed so as to contact with the electrode 10. In the percutaneous electrification patch 1, the anode electrode 11 and the cathode electrode 12 are brought into contact with a target portion of a subject via the conductive parts 20A and 20B to form an electric circuit which causes a feeble current to flow through the portion. The feeble current caused to flow a living body by the electric circuit is a direct current with a current density that is equal to or more than 0.5μA / cm2 and less than 500μA / cm2.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a transcutaneous energization patch.

Background Art

[0002] Patent Documents 1 to 3 disclose examples of various energization patches that can apply energization stimulation.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0004] Patent Document 1 discloses an energization patch that can pass an extremely small amount of current through a living body. In this energization patch, for example, it has been experimentally confirmed that an extremely small amount of current of 0.1 μA to 2 μA or 4 μA to 5 μA can be passed (see Paragraphs 0029 and 0030 of Patent Document 1, etc.). Also, according to a simulated test described later, the current density of the current flowing through this energization patch is, for example, less than 0.5 μA / cm 2 Furthermore. Although Patent Document 1 proposes using such an energization patch for treatment, the improvement effect when using this energization patch for treatment has not been verified, and the improvement effect is unknown. However, there is a desire to improve a target site in a living body (for example, relieve pain) using a small treatment device such as an energization patch, and it is desired to provide such an energization patch.

[0005] An object of the present invention is to provide a transcutaneous electrical patch capable of improving the ameliorating effect on a target site. **Means for Solving the Problems**

[0006] (1) One aspect of the present invention relates to a transcutaneous electrical patch. This transcutaneous electrical patch includes a plurality of electrodes having a positive electrode and a negative electrode, and a conductive layer disposed so as to contact the plurality of electrodes. In this transcutaneous electrical patch, an electric circuit for passing a weak current through the living body is formed by bringing the positive electrode and the negative electrode into contact with the living body through the conductive layer. The weak current flowing through the living body in this electric circuit is a direct current having a current density of 0.5 μA / cm 2 or more and less than 500 μA / cm 2 (2) In this transcutaneous electrical patch, an electric circuit for passing a weak current through the living body is formed by bringing the positive electrode and the negative electrode into contact with the living body through the conductive layer, and the weak current flowing through the living body in the electric circuit is a direct current having a current density of 0.5 μA / cm

[0007] or more and less than 500 μA / cm 2 or more and less than 500 μA / cm 2 (3) According to the findings of the present inventors, it has been found that by setting the weak current flowing through the living body to a direct current higher than an extremely small current (for example, 0.2 μA / cm 2 ), the ameliorating effect on the target site can be significantly improved. Therefore, according to this transcutaneous electrical patch, the ameliorating effect on the target site can be improved. Further, when the current density of the current flowing through the living body becomes 500 μA / cm 2 or more, the user may feel a stimulus. For this reason, in this transcutaneous electrical patch, an electric circuit is formed so that the current density of the current flowing through the living body is less than 500 μA / cm 2 or more. As a result, it becomes possible to use this transcutaneous electrical patch for a long period (for example, attach it to a predetermined site of the user), and the ameliorating effect on the target site can be further improved. 2 (4) In this transcutaneous electrical patch, an electric circuit is formed so that the current density of the current flowing through the living body is less than 500 μA / cm

[0008] (2) In the transcutaneous energization patch described in (1) above, when the electric circuit is connected to a 5 kΩ resistor, it is preferably configured to pass a direct current with a current density of 10 μA / cm 2 or more. In this case, the improvement effect on the target site can be more reliably enhanced.

[0009] (3) In the transcutaneous energization patch described in (1) or (2) above, when the electric circuit is connected to a 5 kΩ resistor, it is preferably configured to pass a direct current with a current density of 35 μA / cm 2 or more. In this case, the improvement effect on the target site can be further enhanced.

[0010] (4) In any one of the transcutaneous energization patches described in (1) to (3) above, when the electric circuit is connected to a 5 kΩ resistor, it is preferably configured to pass a direct current with a current density of 60 μA / cm 2 or more. In this case, the improvement effect on the target site can be further enhanced.

[0011] (5) In any one of the transcutaneous energization patches described in (1) to (4) above, when connected to a 1 kΩ resistor, it is preferably configured to pass a direct current with a current density of less than 500 μA / cm 2 . In this case, regardless of the skin condition, the user is not made to feel irritation, and this transcutaneous energization patch can be more reliably used for a long period, thereby making it possible to further enhance the improvement effect on the target site.

[0012] (6) In any one of the transcutaneous energization patches described in (1) to (5) above, when the electric circuit is connected to a 5 kΩ resistor, the current density of the weak current flowing at the latest 10 minutes after the connection is preferably configured to be 10 μA / cm 2 or more and 175 μA / cm 2 or less. In this case, by attaching the transcutaneous energization patch to the target site for a long time, it becomes possible to continuously improve the improvement effect on the target site.

[0013] (7) Any of the transcutaneous electrical patches of (1) to (6) above further includes a connection part that electrically connects a plurality of electrodes. The conductive layer is composed of a plurality of conductive parts corresponding to each of the positive electrode and the negative electrode. Each of the plurality of conductive parts has a sponge having bubbles and a buffer agent composed of an electrolyte. The solid of the buffer agent is exposed on the inner wall surface of the bubbles. It is preferable that at least one of the plurality of electrodes supports an enzyme that catalyzes a redox reaction. In this case, it is preferable that an electron transfer mediator is fixed to the electrode supporting the enzyme, and it is more preferable that the electron transfer mediator is a mediator of a quinone-based compound or a phenylenediamine-based compound. According to such a configuration, it is possible to more reliably realize making the weak current flowing through the living body within any of the above-described ranges, and to more reliably improve the improvement effect on the target site.

[0014] (8) In any of the transcutaneous electrical patches of (1) to (7) above, the area of each of the plurality of electrodes may be 80 cm 2 or less. In this case, the transcutaneous electrical patch can be miniaturized, and it can be easily realized to attach the transcutaneous electrical patch to the target site of the user for a long time. Thereby, the improvement effect on the target site can be further improved.

[0015] (9) As another aspect, the present invention relates to an operation method of a transcutaneous electrical patch. In this operation method, a weak current is passed through a living body using any of the transcutaneous electrical patches of (1) to (7) above. By such an operation, the improvement effect on the target site can be improved.

Effects of the Invention

[0016] According to the present invention, the improvement effect on the target site can be improved.

Brief Description of the Drawings

[0017]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

DETAILED DESCRIPTION OF THE INVENTION

[0018] Hereinafter, with reference to the drawings, the transcutaneous energization patch according to an embodiment of the present invention will be described in detail. In the description, the same reference numerals may be used for the same elements or elements having the same function, and redundant descriptions will be omitted.

[0019] FIG. 1 is an exploded perspective view of a transcutaneous energization patch according to an embodiment of the present invention. The transcutaneous energization patch 1 is a current patch using a bio-battery using an enzyme. As shown in FIG. 1, it includes an electrode body 10 (a plurality of electrodes), two conductive parts 20 (conductive layers, a plurality of conductive parts), an adhesive layer 30, a separator 40, and a surface film 50. When in use, the transcutaneous energization patch 1 is used by removing the separator 40 and attaching it to the skin (living body) of any part of the subject's (user's) body (for example, shoulder, arm, jaw) with the adhesive layer 30. Although details will be described later, by such attachment, in the transcutaneous energization patch 1, each electrode of the electrode body 10 contacts the subject's part through the conductive part 20, forming an electric circuit that flows a weak current. The weak current that this electric circuit flows through the relevant part of the subject and its adjacent area is, in this embodiment, for example, 0.5 μA / cm 2 or more and 500 μA / cm 2 less, and is a direct current having a current density, and is a current slightly stronger than an extremely weak current. However, in the transcutaneous energization patch 1, it is set to generate a current weaker than the current density of 500 μA / cm 2 which is a criterion for the subject to feel a stimulus. Note that the weak current that the transcutaneous energization patch 1 flows through the relevant part of the subject etc. may be 1 μA / cm 2 or more.

[0020] The electrode body 10 has an anode electrode 11 (negative electrode), a cathode electrode 12 (positive electrode), and a lead 13 (connection part). The lead 13 connects the anode electrode 11 and the cathode electrode 12. The anode electrode 11, the lead 13, and the cathode electrode 12 may be arranged in this order and formed as an integral member. The electrode body 10 has a thickness of, for example, about 0.1 mm to 2.0 mm. The size of the transcutaneous energization patch 1 is preferably, for example, a width of 1 cm to 10 cm and a length of 1 cm to 10 cm. The size (area) of the electrode body 10 in the transcutaneous energization patch 1 is smaller than the size of the entire transcutaneous energization patch 1, and the sizes (areas) of the anode electrode 11 and the cathode electrode 12 may be appropriately modified according to the part to be attached and the range where a weak current is to be flowed as a geometric surface area. For example, it is 80 cm 2 or less, and 50 cm 2The following is 40 cm 2 The following is 30 cm 2 The following is 20 cm 2 The following is 10 cm 2 The following is 1 cm 2 The following is 0.5 cm 2 The following is 0.1 cm 2 It can be the following. Such a small transcutaneous electrical patch 1 may be attached to a pain area, or a plurality of transcutaneous electrical patches 1 may be attached to the pain area. Also, the transcutaneous electrical patch 1 may have a configuration in which one electrode body 10 is arranged, or a configuration in which two or more electrode bodies 10 are arranged. Note that the shape of the transcutaneous electrical patch 1 may be any shape such as a polygon, pentagon, quadrilateral, triangle, circle, etc.

[0021] As materials for the anode electrode 11, cathode electrode 12, and lead 13, carbon materials such as carbon nanotubes, Ketjen black (registered trademark), glassy carbon (registered trademark), graphene, fullerene, carbon fiber, carbon fabric, carbon aerogel, etc.; conductive polymers such as polyaniline, polyacetylene, polypyrrole, poly(p-phenylene vinylene), polythiophene, poly(p-phenylene sulfide), etc.; semiconductors such as silicone, germanium, indium tin oxide (ITO), titanium oxide, copper oxide, silver oxide, etc.; metals such as gold, platinum, titanium, aluminum, tungsten, copper, silver, zinc, magnesium, iron, palladium, etc. can be mentioned. In particular, from the viewpoints of flexibility and electrochemical stability, carbon materials such as carbon fabric and carbon nanotubes are preferable as the material of the electrode body 10. In particular, when an enzyme is fixed to the electrode at a high density, a material in which carbon nanotubes are modified on carbon fabric is preferable as the material of the electrode body 10.

[0022] The anode electrode 11 may carry a catalyst that catalyzes the oxidation reaction. Examples of such catalysts include redox enzymes such as glucose oxidase, glucose dehydrogenase (GDH), D-fructose dehydrogenase (FDH), alcohol oxidase, alcohol dehydrogenase, lactate oxidase, and lactate dehydrogenase. In addition to enzymes, an electrode composed of one or more of magnesium, alloys containing magnesium, aluminum, alloys containing aluminum, calcium, iron, zinc, etc. may be used.

[0023] Also, as shown in FIG. 2, an electron transfer mediator 15 that promotes electron transfer between the electrode (anode electrode 11) and the enzyme 14 that functions as a catalyst is fixed to the anode electrode 11 in the bio-battery. In the anode electrode 11, electrons can be efficiently extracted from, for example, glucose as a fuel by the enzyme 14 and the electron transfer mediator 15 fixed to the electrode. As the electron transfer mediator 15 used here, various ones can be used. For example, phenazines, viologens, cytochromes (e.g., cytochrome b, cytochrome c), phenoxazines, phenothiazines, ferricyanides, such as potassium ferricyanide, ferredoxins, ferrocenes, osmium complexes, and their derivatives, etc. can be mentioned. Examples of the phenazine compound include mediators such as phenazine methosulfate (PMS), methoxy PMS, quinone-based compounds, and phenylenediamine-based compounds, but are not limited thereto. Preferred quinone-based compounds used as the mediator include 1,4-naphthoquinone, 1,2-naphthoquinone, and 2-methyl-1,4-naphthoquinone. Examples of the phenylenediamine-based compounds include N-isopropyl-N'-phenyl-p-phenylenediamine (IPPD), N,N'-diphenyl-p-phenylenediamine (DPPD), and N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD). By using such an electron transfer mediator, it becomes possible to increase the current of the electric circuit when the transcutaneous energization patch 1 is attached to a predetermined site of the subject within the above-described range.

[0024] The cathode electrode 12 is loaded with a catalyst that catalyzes a reduction reaction. Examples of such catalysts include enzymes such as bilirubin oxidase (BOD), laccase, Cu efflux oxidase (Cueo), and ascorbic acid oxidase; transition metal complexes such as iron (II) phthalocyanine; platinum, or at least one metal among titanium, nickel, stainless steel, iron, manganese, zinc, copper, molybdenum, or metal oxides composed of at least one metal among calcium, iron, manganese, zinc, copper, molybdenum, etc.

[0025] The conductive part 20 is a water absorbent arranged to be in surface contact with the anode electrode 11 and the cathode electrode 12. The conductive part 20 has a structure in which dry fuel or electrolyte is encapsulated inside a sponge. The conductive part 20A in contact with the anode electrode 11 contains fuel such as an organic substance that undergoes an oxidation reaction at the anode electrode 11. Examples of fuel include glucose, fructose, ascorbic acid (vitamin C), alcohol, lactic acid, etc. (see also Fig. 2).

[0026] The water absorbent constituting the conductive part 20 contains a buffer as an electrolyte. The buffer is an electrolyte that becomes a buffer solution when made into an aqueous solution. Examples of buffers include salts such as weak acids and weak bases. The water absorbent may or may not contain an electrolyte other than the buffer, for example, a salt of a strong acid and a strong base. Examples of the electrolyte constituting the buffer include weak acids such as phosphoric acid, acetic acid, citric acid, tartaric acid, etc.; sodium salts, potassium salts, etc. of these weak acids; weak bases such as organic amines, and salts thereof, etc. The buffer may be composed of two or more electrolytes. When the water absorbent does not contain a buffer, the water to be absorbed may contain a buffer, or both the water absorbent and the water to be absorbed may contain a buffer.

[0027] After manufacturing the transcutaneous energization patch 1, the water-absorbing body of the conductive part 20 remains in a dry state until it is used. When using the transcutaneous energization patch 1, by supplying water to the transcutaneous energization patch 1, the water-absorbing body absorbs water, and an electrolytic solution containing an electrolyte is encapsulated inside the water-absorbing body. As a result, the anode electrode 11 and the cathode electrode 12 are electrically connected to the skin through the electrolytic solution, and an ion migration path including the anode electrode 11, the conductive part 20A, the skin, the conductive part 20B, and the cathode electrode 12 is formed. For example, cations such as hydrogen ions and sodium ions are transported from the anode electrode 11 toward the cathode electrode 12.

[0028] In the water-absorbing body of the conductive part 20, the buffering agent is encapsulated in a sponge having air bubbles. Examples of the sponge material include synthetic resins such as polyurethane and polyvinyl alcohol; natural polymers such as cellulose, and derivatives thereof. Fine continuous air bubbles are formed inside the sponge. Therefore, after absorbing an electrolytic solution composed of an aqueous solution of an electrolyte into the sponge and then drying it, the solute electrolyte in the sponge becomes dry. It is considered that at least a part of the electrolyte is exposed in a solid state on the inner wall surface of the air bubbles without being incorporated into the sponge material. The sponge can contain, in addition to the electrolyte, a fuel for a bio-battery, a drug that can act on a living body, and other additives.

[0029] The sponge of the conductive part 20 is excellent in water absorption due to capillary action, surface tension, hydrophilicity, etc. Therefore, by simply immersing a part such as the lower surface in water, it can quickly absorb water. Furthermore, solutes such as electrolytes dissolve in water in the internal space of the air bubbles of the sponge, and an electrolytic solution is prepared. Due to the water absorption power of the sponge, the electrolytic solution is uniformly mixed and spreads throughout the water-absorbing body, and the anode electrode 11 and the cathode electrode 12 can be connected to the skin with the electrolytic solution. The water-absorbing body configured using the sponge can move moisture even in a direction against gravity and in a complex shape such as a three-dimensional shape.

[0030] Examples of the sponge constituting the conductive part 20 include those having a pore diameter of, for example, 10 to 500 μm. Specific examples of the pore diameter include 10 μm, 20 μm, 25 μm, 30 μm, 50 μm, 80 μm, 100 μm, 150 μm, 200 μm, 300 μm, 500 μm, etc., or intermediate values, nearby values, etc. between these, but are not limited thereto. Examples of the porosity of the sponge include, for example, 60 to 95%. As the sponge, a polyurethane sponge is preferable, but a sponge having excellent performance such as water absorption can also be suitably used. As the sponge constituting the conductive part 20, for example, Sofras (trade name, manufactured by Aion Co., Ltd.) can be used. Note that the thickness of the sponge constituting the conductive part 20 is about 0.5 mm to 2 mm, but since it has a large number of pores, it is possible to adjust the thickness when incorporated into the transcutaneous energization patch 1.

[0031] In the transcutaneous energization patch 1 using a bio-battery, one or more enzyme electrodes can be used for the anode electrode 11 or the cathode electrode 12. When the water absorbent of the conductive part 20 absorbs water, the energization of the bio-battery is started, and the transcutaneous energization patch 1 is driven by the bio-battery. The water absorbent of the conductive part 20 enables the movement of substances such as ions and fuel between the anode electrode 11 and the cathode electrode 12 and the skin while holding the electrolytic solution like a tank.

[0032] The adhesive layer 30 is a member for attaching the transcutaneous energization patch 1 to the skin of any part of a subject. The adhesive layer 30 can be composed of, for example, a double-sided adhesive tape having insulation properties. Two openings 31 and 32 are provided in the adhesive layer 30, and the anode electrode 11 is housed in one opening 31, and the cathode electrode 12 is housed in the other opening 32. The lead 13 between the anode electrode 11 and the cathode electrode 12 is attached onto the portion 33 between the opening 31 and the opening 32. Thereby, the position of the electrode body 10 with respect to the adhesive layer 30 is fixed. Further, in the adhesive layer 30, the anode electrode 11 housed in the opening 31 comes into contact with the conductive portion 20A, and the cathode electrode 12 housed in the opening 32 comes into contact with the conductive portion 20B. At this time, the outer frame portions of the conductive portions 20A and 20B are also fixed to the adhesive layer 30. With such a configuration, ion insulation is achieved between the conductive portion 20A and the conductive portion 20B. Incidentally, the adhesive layer 30 has a thickness of, for example, about 0.1 mm to 0.5 mm.

[0033] The separator 40 is a member for achieving ion insulation between the conductive portion 20A and the conductive portion 20B together with the adhesive layer 30, and can be formed from, for example, a release paper coated with silicone or the like on the surface of a film or paper such as polyester or polyethylene terephthalate. Two openings 41 and 42 are provided in the separator 40, and the conductive portion 20A is housed in one opening 41, and the conductive portion 20B is housed in the other opening 42. Incidentally, the separator 40 has a thickness of, for example, about 0.05 mm to 0.1 mm.

[0034] The surface film 50 is a member for covering and protecting the electrode body 10 and the conductive portion 20, and can be formed from, for example, a polyvinyl chloride film. When oxygen is used as a catalyst, a window portion 51 is formed at a position corresponding to the cathode electrode 12 of the surface film 50 in order to supply an enzyme to the cathode electrode 12. In order to avoid exposure of the cathode electrode 12, the cathode electrode 12 may be protected using a material such as cotton that is permeable to oxygen in the window portion 51.

[0035] The transcutaneous energization patch 1 having such a configuration can be configured as a small and thin energization patch, and it can be easily realized to be attached to a predetermined part of a subject for a long time. In the transcutaneous energization patch 1, when it is attached to a predetermined part of a subject after being made to absorb water, the anode electrode 11 and the cathode electrode 12 come into contact with the living body via the conductive parts 20A and 20B, and an electric circuit that passes a weak current through the predetermined part (including the adjacent area) can be formed. In the transcutaneous energization patch 1, as the weak current that this electric circuit passes through the living body, when the resistance is 5 kΩ, the current density is 10 μA / cm 2 It is configured to be the above DC current.

[0036] Here, the electrical resistance in the living body to which the transcutaneous energization patch 1 is applied will be described. The electrical resistance of the living body can be divided into the resistance of the skin and the resistance inside the human body. The resistance of the skin changes depending on the wetness of the contact surface etc. (refer to Chapter 4 of the Electrical Installation Work Safety and Health Handbook, Japan Marine Electrical Equipment Association, Incorporated Association). If the skin is dry and hardened, the skin resistance is about 10 kΩ, but it decreases to 1 / 12 when sweating. Also, since the skin resistance when sweating is about 1 kΩ, the transcutaneous energization patch 1 according to the present embodiment, when connected to a resistance of 1 kΩ, has a DC current of 500 μA / cm 2 It is desirable to be configured such that the following DC current flows. Thereby, it is reduced that the subject feels a stimulus.

[0037] Fig. 3 shows the relationship between the current density (μA / cm 2 ) of the current flowing through the electric circuit formed by the transcutaneous energization patch 1 and the elapsed time (minutes). This current density is the current density when the electric circuit of the transcutaneous energization patch 1 is connected to a resistance of 10 kΩ. In the transcutaneous energization patch 1, although the current density is slightly higher immediately after the start, it settles into the range of the weak current described above as time passes. More specifically, the electric circuit formed by the transcutaneous energization patch 1 has a current density of 10 μA / cm 2 or more and 100 μA / cm 2It is configured to pass a direct current through a predetermined part of the subject. Preferably, when the transcutaneous energization patch 1 contacts the predetermined part of the subject with the electric circuit, at the time when a predetermined time (for example, at least 10 minutes) has elapsed, the weak current flowing through the predetermined part is 10 μA / cm 2 or more and 175 μA / cm 2 or less. More specifically, the electric circuit of the transcutaneous energization patch 1 is configured such that the current density of the weak current flowing at the time when at least 10 minutes have elapsed after being connected to a 5 kΩ resistor is 10 μA / cm 2 or more and 175 μA / cm 2 or less. More preferably, the transcutaneous energization patch 1 is configured such that the current density of the weak current flowing at the time when 5 hours or more have elapsed after the electric circuit connects the transcutaneous energization patch 1 to a 5 kΩ resistor is 10 μA / cm 2 or more and 175 μA / cm 2 or less. That is, the transcutaneous energization patch 1 of the present embodiment can be attached to a predetermined part of the subject for a long time to continuously provide a weak current within a predetermined range.

[0038] FIG. 4 shows an example of the current density of the transcutaneous energization patch 1. This is a graph of the current density of one sample of the actually manufactured transcutaneous energization patch 1. According to this transcutaneous energization patch, when connected to a 5 kΩ resistor, at the time when 10 minutes (600 seconds) have elapsed, the current density of the weak current flowing through the predetermined part is 10 μA / cm 2 ~30 μA / cm 2 and the weak current flowing through the predetermined part of the subject also has a current density of 10 μA / cm 2 ~30 μA / cm 2 and is configured to maintain the range. By changing and adjusting the type and amount of the catalyst and electron transfer mediator used in the transcutaneous energization patch 1, the direct current flowing through the electric circuit of the transcutaneous energization patch can be within the above-described range. However, when this electric circuit is connected to a 5 kΩ resistor, the current density is 35 μA / cm 2It may be configured to pass the above-described direct current, and the current density when connected to a 5 kΩ resistor is 60 μA / cm 2 It may be configured to pass the above-described direct current.

Example

[0039] Here, regarding the effect of using the transcutaneous electrical stimulation patch 1 capable of providing the above-described direct current range to a predetermined part of a subject, several experimental examples will be described with reference to FIGS. 5 to 9. Experimental examples 1 to 4 were as follows (1) to (4). (1) Evaluation of delayed muscle soreness using the transcutaneous electrical stimulation patch 1 (see FIG. 5). (2) Results of evaluating the exercise performance using the transcutaneous electrical stimulation patch 1 (see FIG. 6). (3) Results of evaluating the relief of shoulder stiffness using the transcutaneous electrical stimulation patch 1 (see FIG. 7). (4) Results of evaluating the relief of temporomandibular joint disorder using the transcutaneous electrical stimulation patch 1 (see FIGS. 8 and 9).

[0040] First, a large number of transcutaneous electrical stimulation patches 1 (first embodiment) used in Experimental examples (1) to (4) were produced. In the production of the first embodiment of the transcutaneous electrical stimulation patch 1, the following materials were prepared.

[0041] Electrode body 10: As the material, an electrode body 10 having the configuration shown in FIG. 1 was produced (prepared) using carbon fiber (manufactured by Toho Tenax Co., Ltd.) carrying multi-walled carbon nanotubes (manufactured by Baytube). The carbon nanotubes may be manufactured by Meijo Nano Carbon Co., Ltd. and are not particularly limited. Also, the carbon fiber may be manufactured by Toray Industries, Inc. and is not particularly limited. The thickness of the electrode body 10 was 0.3 mm. The areas of the anode electrode 11 and the cathode electrode 12 were each 0.8 cm 2It was. On the anode electrode 11, 4-isopropylaminodiphenylamine and glucose dehydrogenase were supported as a catalyst. On the cathode electrode 12, carbon fibers supporting multi-walled carbon nanotubes and polytetrafluoroethylene were used. As a catalyst, iron phthalocyanine (manufactured by Tokyo Chemical Industry Co., Ltd.) was supported. The lead 13 was made of carbon fiber. The anode electrode 11 and the cathode electrode 12 were joined to this lead 13 by thermal bonding.

[0042] Conductive part 20: 300 μL of 50 mM McIlvaine buffer (pH 5) and 200 mM glucose solution were added to a sponge made of polyurethane (Sofras (trade name), manufactured by Ion Co., Ltd.), and dried to prepare (produce) the conductive part 20. The thickness of the conductive part 20 was 1 mm.

[0043] Adhesive layer 30: As a double-sided tape for skin, a medical double-sided adhesive tape (manufactured by 3M Japan) was used to prepare the adhesive layer 30. The thickness of the adhesive layer 30 was 0.16 mm.

[0044] Separator 40: Using polyester as a material, the separator 40 having the configuration shown in FIG. 1 was produced. However, as the separator 40, single-sided polyethylene-coated paper, polypyropylene, or the like may be used.

[0045] Surface film 50: Using a polyvinyl chloride film as a material, the separator 40 having the configuration shown in FIG. 1 was produced.

[0046] After preparing the above-described materials, the electrode body 10, the conductive part 20, the adhesive layer 30, the separator 40, and the surface film 50 were assembled in the order and arrangement shown in FIG. 1 to produce a large number of first embodiments of the transcutaneous energization patch 1. The current density by the electric circuit of the patch according to the first embodiment was as shown in Table 1 below. The "current density" in Table 1 is the value about 10 minutes after adding the solution containing the substrate, and is a value that slightly decreases after 60 minutes.

[0047]

Table 1

[0048] In the first embodiment of the transcutaneous energization patch 1, when the electrical circuit of the patch is connected to a 10 kΩ resistor at the time when at least 10 minutes have elapsed after adding water to the transcutaneous energization patch, the current density of the weak current flowing is 10 μA / cm 2 ~30 μA / cm 2 That is, even when one hour or more has elapsed, the weak current flowing through a predetermined part of the subject is 10 μA / cm 2 or more. The patch was configured to maintain the above. Also, the open-circuit voltage by the transcutaneous energization patch was about 300 mV. Further, as shown in Table 1, for the patch of the first embodiment, the current density at 5 kΩ connection was 39 μA / cm 2 , and the current density at 1 kΩ connection was 108 μA / cm 2 It was confirmed that a direct current was flowing. That is, the current density of the first embodiment of the transcutaneous energization patch 1 used in the test was below 500 μA / cm 2 , and it was confirmed that there was no risk of skin irritation.

[0049] Also, a second embodiment of the transcutaneous energization patch 1 was produced. To produce the patch according to the second embodiment, first the following materials were prepared. In the anode electrode 11, 1,4-naphthoquinone (manufactured by Tokyo Chemical Industry Co., Ltd.) was used instead of 4-isopropylaminodiphenylamine used in the first embodiment. As the cathode electrode 12, a platinum mesh (manufactured by BAS) was used, and as the lead 13, a stainless steel wire was used. The anode electrode 11 and the cathode electrode 12 were fixed to this lead 13 with an instant adhesive. Otherwise, the assembly was performed in the same manner as in the first embodiment. Power generation was started by adding a 100 mM potassium phosphate buffer solution (pH 7) containing 200 mM glucose to the sponge of the conductive part 20. The current density by the electrical circuit of the patch according to the second embodiment was as shown in Table 2 below. The "current density" in Table 2 is the value about 10 minutes after adding the solution containing the substrate, and the value after 60 minutes has elapsed is slightly decreased.

[0050]

Table 2

[0051] In the second embodiment of the transcutaneous energization patch 1, similar to the first embodiment, after adding the substrate, at the latest when 10 minutes have elapsed, the current density of the weak current flowing when the electric circuit of the patch is connected to a 10 kΩ resistor is 20 μA / cm 2 ~45 μA / cm 2 That is, even when one hour or more has elapsed, the weak current flowing through a predetermined part of the subject is 20 μA / cm 2 or more. The patch was configured to maintain the above. Also, for the patch of the second embodiment, the current density when connected to 5 kΩ was 73 μA / cm 2 and the current density when connected to 1 kΩ was 193 μA / cm 2 It was confirmed that a direct current flowed. That is, the current density of the second embodiment of the transcutaneous energization patch 1 used in the test was less than 500 μA / cm 2 and it was confirmed that there was no risk of skin irritation.

[0052] Also, a third embodiment of the transcutaneous energization patch 1 was produced. To produce the patch according to the third embodiment, first the following materials were prepared. Carbon fibers carrying multi-walled carbon nanotubes were used for both the anode electrode 11 and the cathode electrode 12. This carbon fiber and an alkaline button battery (1.5 V, LR44, manufactured by Panasonic Corporation) were electrically connected. The anode electrode 11 and the cathode electrode 12 were connected with a stainless steel wire (corresponding to the lead 13). Otherwise, the assembly was carried out in the same manner as in the first embodiment of the transcutaneous energization patch 1. Power generation was started by adding 100 mM potassium phosphate buffer (pH 7) to the sponge of the conductive part 20. The current density by the electric circuit of the patch according to the third embodiment was as shown in Table 3 below. The "current density" in Table 3 is the value after about 10 minutes from connecting the electric circuit, and the value after 60 minutes has elapsed decreased slightly.

[0053]

Table 3

[0054] In the third embodiment of the transcutaneous energization patch 1, similar to the first embodiment, after adding the substrate, when the electric circuit of the patch was connected to a 10 kΩ resistor at the latest 10 minutes after the addition, the current density of the weak current flowing was 70 μA / cm 2 ~100 μA / cm 2 That is, even at the time point when one hour or more had elapsed, the weak current flowing through a predetermined part of the subject was 50 μA / cm 2 or more. The patch of the third embodiment was configured to maintain the above. Further, for the patch of the third embodiment, the current density when connected to 5 kΩ was 147 μA / cm 2 , and it was confirmed that a current of 411 μA / cm 2 flowed when connected to 1 kΩ. That is, the current density of the third embodiment of the transcutaneous energization patch 1 used in the test was below 500 μA / cm 2 , and it was confirmed that there was no risk of skin irritation.

[0055] [Experimental Example 1] In Experimental Example 1, delayed muscle soreness was evaluated using the transcutaneous energization patch 1 (first embodiment). Also, in the transcutaneous energization patch 1 (first embodiment), a negative control product that does not conduct electricity, excluding glucose dehydrogenase, iron phthalocyanine, etc. involved in the transfer of electrons, was also used in the test. In this test, while placing the elbow on the pedestal, a dumbbell (male: 7.5 kg, female: 5 kg) was gripped, and the movement of lifting the dumbbell at 1 round trip / 4 seconds and then returning it to the initial position was repeated continuously until the pace could no longer be maintained. The number of subjects was 13 (6 males and 7 females). After this dumbbell exercise was completed, the transcutaneous energization patch 1 or the negative control product prepared above was attached along the muscle fibers to the long head of the biceps brachii of the subject so that the current flowed, and the current density was 10 μA / cm 2 ~30 μA / cm 2A weak current within a certain range was continuously passed through a predetermined part of the subject. This test was conducted in a state where the subject did not know whether the transcutaneous electrical stimulation patch 1 or the negative control was attached. The provision of this weak current was carried out for 12 hours during the period from 1 day after exercise until 1 day passed, and further, it was carried out for 12 hours during the period from 1 day passed until 2 days passed. Bedtime was included in each 12-hour period. Also, after the above-described dumbbell exercise ended, after an interval of at least 2 weeks or more, the subject conducted the same dumbbell test again. The subjects who had the transcutaneous electrical stimulation patch 1 attached in the first dumbbell test attached the negative control and conducted the test in the same manner. On the other hand, the subjects who had the negative control attached in the first dumbbell test attached the transcutaneous electrical stimulation patch 1 and conducted the test in the same manner.

[0056] Two days after the dumbbell exercise ended, each subject was asked to evaluate the state of delayed muscle soreness (a type of muscle pain). The evaluation criteria used the Japanese version of the Talag scale and were as follows (24 levels in 0.25 increments between 0 and 6). (Refer to Physical Therapy Science, 22(1), 125 - 131(2007)) 0: No pain. 1: Uncomfortable feeling 2: Slightly distinct pain 3: A bit more distinct pain 4: Distinct pain 5: Strong pain 6: Intolerable pain.

[0057] Figure 5 shows the results of the pain intensity 2 days later. As shown in Figure 5, it was confirmed that when using the transcutaneous electrical stimulation patch 1 (Example 1, with current), the pain intensity when performing the energization treatment 12 hours × 2 times after the dumbbell exercise was lower than the pain intensity when attaching the negative control (without current) and not performing the energization treatment. The p-value was calculated by the Wilcoxon signed-rank test, and it was also confirmed that p < 0.05. Thus, according to Experimental Example 1 using the patch of the first embodiment, the current density was 10 μA / cm 2 ~30 μA / cm 2It was confirmed that the pain in a predetermined site can be improved by passing a weak current within a certain range through the predetermined site.

[0058] [Experimental Example 2] In Experimental Example 2, the exercise performance using the transcutaneous energization patch 1 (First Embodiment) was evaluated. In this test, the same dumbbell exercise as in Experimental Example 1 was performed, and the number of times of the first dumbbell exercise was counted. The number of subjects was 13, the same as in Experimental Example 1. After this dumbbell exercise was completed, in the same manner as in Experimental Example 1, on the first day and the second day, for 12 hours each (12 hours × 2 times), the above-described transcutaneous energization patch 1 (First Embodiment) or a negative control was attached to the biceps brachii. Experimental Example 2 was carried out in a state where the subjects did not know whether the transcutaneous energization patch 1 or the negative control was attached. When the transcutaneous energization patch 1 was attached, a weak current in the range of 10 μA / cm 2 ~30 μA / cm 2 was continuously passed through a predetermined site of the subject. On the other hand, when the negative control was attached, it means that the process of passing a weak current in the range of 10 μA / cm 2 ~30 μA / cm 2 was not performed.

[0059] Three days after performing the first dumbbell exercise, each of the subjects was made to perform the same dumbbell exercise as the first time and continue until their arms could no longer be lifted, and the number of dumbbell repetitions in the second time was counted. Then, for each subject, the ratio of "the number of dumbbell repetitions in the second time / the number of dumbbell repetitions in the first time" was calculated as the exercise repetition ratio (%). Similar to Example 1, after leaving a gap of more than two weeks without applying a load to the biceps brachii, the same test was conducted again. At this time, a negative control was applied to the subjects who had the transcutaneous electrical patch 1 applied in the previous dumbbell test, and the test was conducted in the same manner. On the other hand, the transcutaneous electrical patch 1 (Example 1) was applied to the subjects who had the negative control applied in the previous dumbbell test, and the test was conducted in the same manner. Fig. 6 shows the exercise repetition ratios calculated in this way, divided into a first group (with electrical stimulation treatment) and a second group (without electrical stimulation treatment). As shown in Fig. 6, it was confirmed that the first group, which was subjected to electrical stimulation treatment for 12 hours × 2 times after the dumbbell exercise using the transcutaneous electrical patch 1 (Example 1), improved the number of times of lifting the dumbbell. It was also confirmed by the Wilcoxon signed-rank test that the p-value was p < 0.01. Thus, according to Experimental Example 2 using the patch of Example 1, it was confirmed that the exercise ability was improved by continuously applying a weak electric current in the range of 10 μA / cm 2 ~30 μA / cm 2 .

[0060] Next, using the patch of Example 2 instead of the patch of Example 1, the same test as Experimental Example 2 described above was conducted. However, the application time was 1 hour on the first day and 4 hours on the second day. The experiment was carried out on a 40-year-old male (one person). As a result, the exercise repetition ratio (%) when the negative control was applied was 46%. On the other hand, the exercise repetition ratio (%) when the patch of Example 2 was applied was 152%. Therefore, it was confirmed that the exercise ability was improved by continuously applying a weak electric current in the range of 20 μA / cm 2 ~45 μA / cm 2 .

[0061] Subsequently, using the patch of the third embodiment instead of the patch of the first embodiment, the same test as in Experimental Example 2 described above was conducted. However, the application time was 4 hours on the first day and 4 hours on the second day. The test was performed on a 30-year-old male (one person). As a result, the percentage of the number of movements when the negative control was applied was 88%. On the other hand, the percentage of the number of movements when the patch of the third embodiment was applied was 108%. Therefore, it was confirmed that the exercise ability was improved by continuously applying a weak current in the range of 70 μA / cm 2 ~100 μA / cm 2 . Also, when evaluating the pain after two days, the pain when the negative control was applied was "3" in the evaluation, while the pain evaluation when the patch of the third embodiment was applied was "0". That is, it was confirmed that there was an effect of reducing pain by flowing the above-described current.

[0062] [Experimental Example 3] In Experimental Example 3, the elimination of stiff shoulders using the transcutaneous electrical patch 1 was evaluated. In this test, the above-described transcutaneous electrical patch 1 (first embodiment) was attached to the painful part of the shoulders of the subjects in the first group (15 people) for 12 hours, and a weak current in the range of 10 μA / cm 2 ~30 μA / cm 2 was continuously passed through the predetermined part of the subjects. Then, the reduction of pain after a certain period of time (12 hours later, 24 hours later, 36 hours later, 60 hours later) was investigated. On the other hand, a negative control was attached to the painful part of the shoulders of the subjects in the second group (15 people), and the reduction of pain only by natural healing over time was investigated. The subjects were made not to know which patch was attached. The evaluation criteria were the same as in Experimental Example 1, and how much the pain changed from the pain before application was recorded. The test results are shown in FIG. 7. As shown in FIG. 7, in the first group where the transcutaneous electrical patch 1 (first embodiment) was used to perform the energization treatment on the painful part of the shoulder for 12 hours, it was confirmed that the pain was improved more than in the second group where no energization treatment was performed.

[0063] As a comparative example, the change in pain was similarly recorded using a general magnetic therapy device. The test was conducted on 12 subjects. The general magnetic therapy device was applied continuously for three days. As a result, the change in pain was -1 after 24 hours from the start of application of the magnetic therapy device, -0.9 after 36 hours, and -0.79 after 60 hours, showing an improving trend. However, the percutaneous electrical patch (First Embodiment) had a higher pain reduction effect. Note that the percutaneous electrical patch (First Embodiment) had a shorter application time and a higher reduction effect than the comparative example.

[0064] [Experimental Example 4] In Experimental Example 4, the pain relief degree of temporomandibular joint disorder using the percutaneous electrical patch 1 (First Embodiment) was evaluated. In this test, one subject (a woman in her 30s) diagnosed with temporomandibular joint disorder was asked to attach the above-mentioned percutaneous electrical patch 1 along the muscle fibers of the masseter muscle to the painful area of the temporomandibular joint at bedtime for 4 days, and a weak electric current in the range of 10 μA / cm 2 ~30 μA / cm 2 was continuously passed through the predetermined part of the subject. Then, every morning, the degree of pain improvement was evaluated using the Visual Analogue Scale (VAS) in the range of 0 (no pain) to 100 (the most intense pain). Regarding the degree of pain improvement, tenderness pain, pain during opening, pain during chewing, and the degree of interference with daily life were evaluated. Tenderness pain indicates the muscle pain when a 1 kg pressure is applied to the muscle part of the jaw, pain during opening indicates the pain of the jaw when opening the mouth, and pain during chewing indicates the pain of the jaw when chewing food. The degree of interference with daily life is a criterion for how much the pain of the jaw interferes with life, and was evaluated in the range of 0 (no interference) to 100 (the most severe interference).

[0065] Here, temporomandibular joint disorder will be described. Temporomandibular joint disorder is said to be the third most common dental disease after dental caries and periodontal disease. The number of patients showing some symptoms in the temporomandibular joint is estimated to be about 19 million in Japan. It is recommended that the first choice for the treatment of temporomandibular joint disorder be a conservative, reversible, and evidence-based treatment method (refer to the Guidelines for the Treatment of Temporomandibular Joint Disorder 2020, Japan Temporomandibular Joint Society, Incorporated Association). Among temporomandibular joint disorders, the basic treatment for the most common myalgia disorder (Type I) is based on physical therapy. This includes not only patients with only Type I but also those with concurrent temporomandibular joint pain disorder (Type II), temporomandibular joint disc disorder (Type III), and degenerative temporomandibular joint disorder (Type IV). Specifically, there are self-massage of the affected area, warm compress to warm the affected area, and pain relief therapy by electrical stimulation (transcutaneous electrical nerve stimulation). Transcutaneous electrical nerve stimulation is said to cause muscle contraction and relaxation by electrical stimulation and relieve muscle hypertonia. However, there are also cases where these physical therapies are not sufficient for treatment. There is also a systematic review that states that the effectiveness of treatment by transcutaneous electrical nerve stimulation could not be sufficiently demonstrated (T. List, S. Axelsson, Journal of Oral Rehabilitation (2010)). Therefore, there is a need for more effective physical therapies that can relieve pain.

[0066] Electrotherapeutic devices other than transcutaneous electrical nerve stimulation have only been applied to parts of the body below the neck, and their effectiveness in the treatment of temporomandibular joint disorder was unknown. In particular, there were no reported cases of the application of weak direct current to temporomandibular joint disorder, and it was not clear how much current should be passed for treatment.

[0067] Figure 8 is a table showing the degree of improvement of temporomandibular joint disorder in Experimental Example 4. As shown in Figure 8, by continuously attaching the transcutaneous energization patch 1 to the painful area of the jaw during sleep for 4 days and continuously passing a weak current within the above-mentioned range, it was confirmed that the pain of temporomandibular joint disorder, which is difficult to cure, can be significantly improved. In particular, on the 5th day, it was confirmed that there was a dramatic improvement.

[0068] Another test was conducted on one subject (a woman in her 60s) diagnosed with temporomandibular joint disorder as described above. This subject had concurrent type I, II, III, and IV temporomandibular joint disorders and underwent self-massage and transcutaneous electrical stimulation therapy, which are normal physical therapies, but the pain could not be relieved. Similarly to the above, transcutaneous energization patch 1 (Example 1) was applied during sleep. However, it was applied once a day for two weeks. As a result, as shown in Fig. 9, pain relief was observed from the 5th day of use for tenderness and from the 1st day of use for pain during opening. For pain during opening, pain relief continued even two weeks after use, and a higher effect than the existing treatment methods was observed. Also, transcutaneous energization patch 1 used in this test was 2 cm wide and 5 cm long. Depending on the subject, pain may occur over a wider area, and as the size of the patch, the width is 1 cm or more, preferably 3 cm or more, more preferably 4 cm or more. The length of the patch is 1 cm or more, preferably 3 cm or more, more preferably 4 cm or more, 5 cm or more, 6 cm or more. When considering the area of the current patch, in order to apply it to the pain area, it is 50 cm 2 Hereinafter, preferably 40 cm 2 Hereinafter, more preferably 30 cm 2 It was found that it is desirable to be the following. Also, 1 cm 2 Or more, preferably 5 cm 2 Or more of the patch is desirable, and multiple small patches can be applied and adjusted to an appropriate area.

[0069] In the above-described Experimental Examples 1 to 4 (First Embodiment), the weak current (current density) provided to the subject was in the range of 10 μA / cm 2 ~30 μA / cm 2 . On the other hand, when using a slightly higher weak current (20 to 45 μA / cm 2 ) for which an improvement effect on exercise performance was observed (Second Embodiment), it is considered that the cell damage recovery effect was higher. Therefore, also in the treatment of temporomandibular joint disorder, by passing a current with a current density of 20 to 45 A / cm 2 (when a 10 kΩ resistor is connected) using the patch of the Second Embodiment, an improvement effect similar to or higher than the above is expected.

[0070] In addition, the current density of the patch in the examples of Japanese Patent Application Laid-Open No. 2016-144634 was verified. FIG. 10 is a diagram showing the test method used for the verification. The verification results were as follows. There were the following three types of metal batteries in the prior art. 1) Titanium and silver 2) Titanium and copper 3) Titanium and zinc In this verification method, 10 mL of physiological saline (PBS) was infiltrated into a nonwoven fabric, and as shown in FIG. 10, two metal electrodes were placed on this nonwoven fabric to form an electric circuit that was electrically connected. This simulated the actual use (attachment to a living body). The current value of each such electric circuit was measured. The measurement results were as shown in Table 4 below. That is, the current density of the current flowing through the energized patch of the prior art was smaller than 0.5 μA / cm 2 Furthermore.

[0071]

Table 4

[0072] In addition, in the verification method in which the electrodes of titanium and zinc were immersed in physiological saline and electrically connected while stirring, when connected to a 1000 kΩ resistor, it was confirmed that a current of 700 mV and 0.7 μA / cm 2 flowed. For this reason, when flowing a current of 650 μA described in the examples of Japanese Patent Application Laid-Open No. 2016-144634, it was confirmed that an electrode area of 100 cm 2 or more was required, and it was a very large structure.

[0073] As described above, according to the transcutaneous energization patch 1 according to the present embodiment, an electric circuit for flowing a weak current through a subject's site is formed by bringing the anode electrode 11 and the cathode electrode 12 into contact with the site via the conductive parts 20A and 20B, and the weak current flowing through this electric circuit to the living body is 0.5 μA / cm 2 or more and 500 μA / cm 2is a direct current less than this value. According to the findings of the present inventors, as described above, the weak electric current flowing through the living body is a current density slightly higher than an extremely small current (0.2 μA / cm 2 or less), which is a direct current having a current density of 0.5 μA / cm 2 or more. It has been found that by setting the direct current to this value, the improvement effect on the target site can be significantly improved. Therefore, according to this transcutaneous energization patch 1, the improvement effect on the target site can be improved. Further, when the current density of the current flowing through the living body becomes 500 μA / cm 2 or more, the user may feel a stimulus. For this reason, in this transcutaneous energization patch 1, an electric circuit is formed such that the current density of the current flowing through the living body is less than 500 μA / cm 2 This makes it possible to use the transcutaneous energization patch 1 for a long period of time (attach it to a predetermined site of the user), and further improve the improvement effect on the target site.

[0074] In addition, in the transcutaneous energization patch 1 according to the present embodiment, the formed electric circuit is configured to pass a direct current having a current density of 10 μA / cm 2 or more when connected to a 5 kΩ resistor. Thereby, the improvement effect on the target site can be more reliably improved. Note that this electric circuit may be configured to pass a direct current having a current density of 35 μA / cm 2 or more when connected to a 5 kΩ resistor, or may be configured to pass a direct current having a current density of 60 μA / cm 2 or more.

[0075] In addition, in the transcutaneous energization patch 1 according to the present embodiment, when connected to a 1 kΩ resistor, it is configured to pass a direct current having a current density of less than 500 μA / cm 2 This prevents the user from feeling a stimulus regardless of the state of the skin, allowing this transcutaneous energization patch to be used more reliably for a long time, thereby further improving the improvement effect on the target site.

[0076] Also, in the transcutaneous energization patch 1 according to the present embodiment, in the electrical circuit formed, when at least 10 minutes have elapsed after being connected to a 5 kΩ resistor, the current density of the weak current flowing is 10 μA / cm 2 or more and 175 μA / cm 2 or less. Thereby, by attaching the transcutaneous energization patch 1 to the target site for a long period of time, it becomes possible to continuously improve the improvement effect on the target site.

[0077] Also, in the transcutaneous energization patch 1 according to the present embodiment, the conductive part 20 is composed of conductive parts 20A and 20B corresponding to the anode electrode 11 and the cathode electrode 12 respectively. Each of the conductive parts 20A and 20B has a sponge having bubbles and a buffer agent made of an electrolyte, and the solid of the buffer agent is exposed on the inner wall surface of the bubbles. Further, at least one of the anode electrode 11 and the cathode electrode 12 carries an enzyme that catalyzes a redox reaction. Furthermore, an electron transfer mediator 15 is fixed to the electrode carrying the enzyme (for example, the anode electrode 11), and the electron transfer mediator 15 is a mediator of a quinone-based compound or a phenylenediamine-based compound. According to such a configuration, it is possible to more surely make the weak current flowing through the living body fall within any of the above-described ranges, and more surely improve the improvement effect on the target site.

[0078] Also, in the transcutaneous energization patch 1 according to the present embodiment, the area of each of the anode electrode 11 and the cathode electrode 12 may be 80 cm 2 or less. In this case, the transcutaneous energization patch 1 can be miniaturized, and it can be easily realized to attach the transcutaneous energization patch 1 to the target site of the user for a long period of time. Thereby, the improvement effect on the target site can be further improved.

[0079] As described above, the transcutaneous energization patch 1 according to the present embodiment has been explained. However, the present invention is not limited to the above embodiment, and various modifications can be applied. For example, in the above embodiment, the case of using a bio-battery has been exemplified. However, as long as an electric circuit that passes a weak current through a part of a subject who is a living body is formed, and the weak current passed through the part of the subject by this electric circuit is 0.5 μA / cm 2 A direct current having the above current density may be used with a patch having another configuration. For example, an energization patch having a configuration using a button battery shown in the third embodiment described above may be used, or a thin-film battery may be used instead of the button battery. However, in order to attach the transcutaneous energization patch to the part of the subject over a long period of time, it is preferable that the transcutaneous energization patch is small and thin.

Explanation of reference numerals

[0080] 1... Transcutaneous energization patch, 10... Electrode body (a plurality of electrodes), 11... Anode electrode (negative electrode), 12... Cathode electrode (positive electrode), 13... Lead (connection part), 14... Enzyme, 15... Electron transfer mediator, 20, 20A, 20B... Conductive part (conductive layer, a plurality of conductive parts).

Claims

1. A plurality of electrodes having a positive electrode and a negative electrode, A conductive layer disposed so as to contact the plurality of electrodes, A transcutaneous energization patch comprising: In the transcutaneous energization patch, an electric circuit is formed that passes a weak current through the living body by bringing the positive electrode and the negative electrode into contact with the living body through the conductive layer, and the weak current passed through the living body by the electric circuit is 0.5 μA / cm ２ or more and 500 μA / cm ２ The transcutaneous energization patch is a direct current having a current density of less than that.

2. When connected to a 5 kΩ resistor, the electric circuit is configured to pass a direct current with a current density of 10 μA / cm ２ or more. The transcutaneous energization patch according to claim 1.

3. When connected to a 5 kΩ resistor, the electric circuit is configured to pass a direct current with a current density of 35 μA / cm ２ or more. The transcutaneous energization patch according to claim 1.

4. When connected to a 5 kΩ resistor, the electric circuit is configured to pass a direct current with a current density of 60 μA / cm ２ or more. The transcutaneous energization patch according to claim 1.

5. When connected to a 1 kΩ resistor, the electric circuit is configured to pass a direct current with a current density of less than 500 μA / cm ２ ​ The transcutaneous energization patch according to claim 1.

6. The electric circuit is configured such that the current density of the weak current flowing at the latest 10 minutes after being connected to a 5 kΩ resistor is 10 μA / cm ２ or more and 175 μA / cm ２ or less. The transcutaneous energization patch according to claim 1.

7. Further comprising a connection part for electrically connecting the plurality of electrodes, The conductive layer is composed of a plurality of conductive parts corresponding to each of the positive electrode and the negative electrode, and each of the plurality of conductive parts has a sponge having bubbles and a buffer agent composed of an electrolyte, and the solid of the buffer agent is exposed on the inner wall surface of the bubbles, At least one of the plurality of electrodes supports an enzyme that catalyzes a redox reaction, The transcutaneous energization patch according to any one of claims 1 to 6.

8. An electron transfer mediator is immobilized on the electrode supporting the enzyme, The transcutaneous energization patch according to claim 7.

9. The electron transfer mediator is a mediator of a quinone-based compound or a phenylenediamine-based compound, The transcutaneous energization patch according to claim 8.

10. The area of each of the plurality of electrodes is 80 cm ２ as follows: The transcutaneous energization patch according to claim 1.

11. An operation method of passing a weak current through the living body using the transcutaneous energization patch according to claim 1.

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