Heating implement for alleviation of stiffness

Abstract

The purpose of the present invention is to provide a novel means that makes it possible to more easily alleviate stiffness caused by rheumatoid arthritis or osteoarthritis. Another purpose of the present invention is to provide a skin heat retention method. Provided is a heat-generating implement for alleviation of stiffness caused by rheumatoid arthritis or osteoarthritis, said heat-generating implement comprising a heat-generating composition that generates heat upon contact with oxygen and an accommodation bag that accommodates the heat-generating composition, wherein at least part of the accommodation bag is constituted by an air-permeable packaging material, and the temperature of heat generation is not higher than 47°C. Also provided is a skin heat retention method comprising a step for setting a heat-generating implement onto part of the skin of a subject having stiffness caused by rheumatoid arthritis or osteoarthritis and warming said part of the skin to 37-42°C for not less than four hours.

Description

Heating device for relieving stiffness

[0001] The present invention relates to a heating device for relieving stiffness caused by rheumatoid arthritis or osteoarthritis and a method for keeping skin warm.

[0002] Stiffness is known to be one of the symptoms caused by rheumatoid arthritis and osteoarthritis. Stiffness is known to be observed in joints such as the hands, knees, and ankles, and stiffness in the hands is particularly common. For example, it has been reported that "morning stiffness," which is a feeling of difficulty moving the joints upon waking up, is a symptom that often appears in the early stages of rheumatoid arthritis (Non-Patent Document 1).

[0003] Known methods for relieving stiffness include taking Chinese herbal medicines and antirheumatic drugs. Another typical method for relieving stiffness in the fingers is to immerse the fingers in a paraffin bath heated to approximately 50°C. However, there is a problem in that the fingers cannot be used and movement is restricted while in the paraffin bath or while covered in paraffin. Furthermore, paraffin baths are generally performed at medical institutions, requiring the patient to visit the hospital. Furthermore, once stiffness occurs, it often takes between one hour and half a day for the stiffness to resolve, making it difficult to secure sufficient time for it to resolve. Morning stiffness, in particular, is difficult to secure between one hour and half a day after waking up, causing significant disruption to daily life.

[0004] Medical Note (medicalnote.jp), "What are the symptoms of rheumatoid arthritis? Be careful if you feel stiff joints in the morning," last updated 2015 / 07 / 22, https: / / medicalnote.jp / contents / 150702-000008-OEVUEQ

[0005] An object of the present disclosure is to provide a new means for more simply alleviating stiffness caused by rheumatoid arthritis or osteoarthritis, and a method for keeping skin warm.

[0006] The present inventors have manufactured a heating device in which an exothermic composition that generates heat upon contact with oxygen is housed in a storage bag, at least a portion of which is made of a breathable packaging material. Through extensive research, the present inventors have found that when subjects who suffer from morning stiffness wear the heating device before going to bed and the heating temperature of the heating device is set to 47°C or less, morning stiffness can be alleviated.

[0007] The inventors also discovered that by attaching the heating device to a part of the skin of a subject experiencing stiffness due to rheumatoid arthritis or osteoarthritis, the part of the skin can be heated and kept warm at a temperature of 37°C or higher and 42°C or lower for four hours or more.

[0008] The present invention was completed through further investigation based on this finding, and the present disclosure encompasses, for example, the following representative inventions. Item 1. A heating device for relieving stiffness caused by rheumatoid arthritis or osteoarthritis, comprising an exothermic composition that generates heat upon contact with oxygen and a storage bag containing the exothermic composition, at least a portion of the storage bag being made of a breathable packaging material, and the temperature at which the composition is heated is 47°C or lower. Item 2. The heating device for relieving stiffness according to Item 1, wherein the heating device maintains heat at 40°C or higher for 4 hours or longer, preferably 6 hours to 16 hours. Item 3. The heating device for relieving stiffness according to Item 1 or 2, wherein the average temperature during the time the heating device maintains heat at 40°C or higher is 42°C to 46°C. Item 4. The heating device for relieving stiffness according to any one of Items 1 to 3, wherein the stiffness is stiffness in the fingers. Item 5. Item 6. The heating device for relieving stiffness according to any one of Items 1 to 4, wherein the stiffness is morning stiffness. Item 7. The heating device for relieving stiffness according to any one of Items 1 to 5, which is intended to be worn before sleep on a part of the skin of a subject who experiences stiffness due to rheumatoid arthritis or osteoarthritis. Item 8. The heating device for relieving stiffness according to any one of Items 1 to 6, which is intended to be used on a subject under 60 years of age, preferably 18 to 60 years of age, who experiences stiffness due to rheumatoid arthritis or osteoarthritis. Item 9. The heating device for relieving stiffness according to any one of Items 1 to 7, wherein the storage bag comprises a breathable first packaging material and a second packaging material, the first packaging material and the second packaging material being joined around the periphery of the storage portion area so that the storage portion can contain the exothermic composition, and the exothermic composition is contained in the storage portion. Item 9. The heating device for relieving stiffness according to any one of Items 1 to 8, which is intended for use by a woman.Item 10. The heating tool for relieving stiffness according to any one of Items 1 to 9, wherein the first packaging material and the second packaging material include the following combinations: (1) a combination of a first packaging material having an air permeation flow rate of 10 ml / min to 18 ml / min and a second packaging material having an air permeation flow rate of 0 ml / min to 18 ml / min, (2) a combination of a first packaging material having an air permeation flow rate of 10 ml / min to 17 ml / min and a second packaging material having an air permeation flow rate of 5 ml / min to 17 ml / min, or (3) a combination of a first packaging material having an air permeation flow rate of 13 ml / min to 15 ml / min and a second packaging material having an air permeation flow rate of 10 ml / min to 16 ml / min. Item 11. Item 11. A heating tool set for relieving stiffness caused by rheumatoid arthritis or osteoarthritis, comprising the heating tool for relieving stiffness described in any one of Items 1 to 10 and a holder to be attached to a portion of the skin of a subject experiencing stiffness caused by rheumatoid arthritis or osteoarthritis, the holder having a holding part capable of holding the heating tool for relieving stiffness. Item 12. A method for keeping skin warm, comprising the step of attaching the heating tool to a portion of the skin of a subject experiencing stiffness caused by rheumatoid arthritis or osteoarthritis, and warming the portion of skin at a temperature of 37°C or higher and 42°C or lower for 4 hours or more (preferably 6 hours to 16 hours). Item 13. The method according to Item 12, wherein the stiffness is stiffness in the fingers. Item 14. The method according to Item 12 or 13, wherein the stiffness is morning stiffness. Item 15. The method according to any one of Items 12 to 14, wherein the heating tool is attached before sleep. Item 16. Item 17. The method according to any one of Items 12 to 15, wherein the subject is under 60 years old, preferably between 18 and 60 years old. Item 18. The method according to any one of Items 12 to 17, wherein the heating device is attached to at least a part of the hand. Item 19. The method according to any one of Items 12 to 17, wherein the subject is female.

[0009] According to the present disclosure, there is provided a heating device for relieving stiffness caused by rheumatoid arthritis or osteoarthritis, the heating device comprising an exothermic composition that generates heat upon contact with oxygen and a storage bag containing the exothermic composition, at least a portion of the storage bag being made of a breathable packaging material, and the heat generated temperature being 47° C. or less. According to the present disclosure, there is provided a method for keeping skin warm, comprising the steps of attaching a heating device to a portion of the skin of a subject experiencing stiffness caused by rheumatoid arthritis or osteoarthritis, and warming the portion of the skin to a temperature of 37° C. or higher and 42° C. or lower for four hours or more.

[0010] 1 shows an example of a heating tool of the present disclosure; 2 shows an example of a heating tool holder; 3 shows an example of a heating tool holder; 4 shows the relationship between the heating temperature and the duration of heating of the heating tool used in Test Example 1; 5 shows the skin temperature when the heating tool is worn; and 6 shows the results of recording the intensity of morning stiffness (MS score) and the duration of morning stiffness.

[0011] Hereinafter, the embodiments included in the present disclosure will be described in more detail. In the present disclosure, "comprises" also means "substantially consists of" or "consists of."

[0012] 1) Heat-generating device for relieving stiffness caused by rheumatoid arthritis or osteoarthritis The present disclosure provides a heat-generating device for relieving stiffness caused by rheumatoid arthritis or osteoarthritis. Specifically, the present disclosure provides a heat-generating device for relieving stiffness caused by rheumatoid arthritis or osteoarthritis, comprising an exothermic composition that generates heat upon contact with oxygen and a storage bag containing the exothermic composition, at least a portion of the storage bag being made of a breathable packaging material, and having a heat generation temperature of 47°C or less.

[0013] Heating Temperature The heating temperature (maximum heating temperature) of the heating tool of the present disclosure is 47° C. or less. The heating temperature is preferably 46° C. or less, and more preferably 45° C. or less.

[0014] Although not limiting the present disclosure, the duration for which the heating tool of the present disclosure generates heat to 40°C or higher is preferably 6 hours or more, more preferably 8 hours or more, even more preferably 10 hours or more, and particularly preferably 12 hours or more. There is no upper limit to the duration, and it may be determined appropriately depending on the desired duration for which the heating tool with a heat generation temperature of 40°C or higher is worn on the skin (particularly joints such as hands, knees, and ankles). The duration for which the heating tool of the present disclosure generates heat to 40°C or higher is more preferably 6 hours or more and 16 hours or less, and particularly preferably 8 hours or more and 14 hours or less.

[0015] Although not limiting the present disclosure, the average temperature of the heating tool of the present disclosure while it heats up to 40° C. or higher is preferably 42° C. or higher and 46° C. or lower. The average temperature is more preferably 42.5° C. or higher and 45.5° C. or lower, and even more preferably 43° C. or higher and 45° C. or lower.

[0016] In this disclosure, the heat generation temperature and duration are determined in accordance with measurements based on JIS S4100:2007. Specifically, according to the procedure specified in JIS S4100:2007, a specified underlayment and a heating tool holder (using a heating tool holder instead of a covering material) are placed on the heating section, and the temperature is raised to 30°C and maintained within ±1°C. The heating tool (heat generation tool housed in an outer bag) is left in an atmosphere at the same ambient temperature for more than two hours, and then heated according to the usage method. The temperature is then measured according to the specified procedure (n=10). By following this procedure, the heating tool's heat generation temperature (maximum heat generation temperature), the duration of the heating tool's heat generation at 40°C or above, and the average temperature during the heat generation at 40°C or above are determined. Test Example 1, described below, uses values ​​determined according to this procedure. The heating tool holder is described in the same manner as the heating tool holder used in Test Example 1, described below.

[0017] Although the heating tool of the present disclosure is not limited to this, the time required to reach a heating temperature of 40°C (rise time) is, for example, within 12 minutes, more preferably within 7 minutes, from the time the heating tool is removed from the outer bag.

[0018] As described above, the heating tool of the present disclosure has a heat generation temperature of 47°C or less. The heating tool satisfies the heat generation temperature and includes an exothermic composition that generates heat upon contact with oxygen, and a storage bag containing the exothermic composition, at least a portion of which is made of a breathable packaging material. According to the heating tool of the present disclosure, by attaching the heating tool to a portion of the skin, stiffness caused by rheumatoid arthritis or osteoarthritis can be alleviated, as shown in the test examples described below. While not limiting the present disclosure, the following heating tool is provided as an example of the heating tool.

[0019] Storage Bag The storage bag is a storage bag that stores the exothermic composition, and at least a portion of the storage bag is breathable. The storage bag prevents leakage of the exothermic composition and is durable against heat generation at a heat generation temperature of 47°C or less. The storage bag is usually a flat bag, and the exothermic composition is stored in the internal space (storage section) of the storage bag. The shape of the storage bag is not limited, and may be any shape, including quadrangular (square, rectangular, etc.), triangular, circular, elliptical, semicircular, etc. An example of the storage bag is the bag shown in Figure 1.

[0020] In Fig. 1, the heating tool 11 includes an exothermic composition 12 and a breathable storage bag 13 that contains the exothermic composition 12. Fig. 1 shows an example in which the storage bag 13 includes a first packaging material 131 and a second packaging material 132, and the first packaging material 131 and the second packaging material 132 are joined at the periphery of the area of ​​the storage section 14 so that the exothermic composition 12 can be contained in the storage section 14. The first packaging material 131 is breathable. The second packaging material 132 may or may not be breathable.

[0021] First Packaging Material The first packaging material 131 is not limited as long as it is breathable, and examples thereof include breathable resin films, breathable woven fabrics, breathable nonwoven fabrics, etc. The resin films, woven fabrics, nonwoven fabrics, etc. may be used singly or in combination of two or more. The resin films, woven fabrics, nonwoven fabrics, etc. may be joined together as desired or may be layered to form a laminated structure. As an example, when the first packaging material 131 has a laminated structure, a resin film may be disposed on the inside of the storage bag 13 (the storage section 14 side), and a woven fabric or nonwoven fabric may be disposed on the outside of the storage bag 13. Alternatively, when the first packaging material 131 has a laminated structure, a woven fabric or nonwoven fabric may be disposed on the inside of the storage bag 13, and a resin film may be disposed on the outside of the storage section 13. When the first packaging material 131 has a laminated structure, the resin film, woven fabric, nonwoven fabric, etc. may be disposed in any order and in any number of layers.

[0022] The first packaging material 131 is not limited as long as it has the breathability required for the heating tool to generate heat at a heating temperature of 47°C or less upon contact with oxygen, as described above. While not limiting the present disclosure, the breathability of the first packaging material 131 capable of generating heat at a heating temperature of 47°C or less is preferably, for example, 18 ml / min or less. A more preferred example of the breathability is an air permeation flow rate of 17.5 ml / min or less, with even more preferred examples being 17 ml / min or less, 16.5 ml / min or less, and 16 ml / min or less. Furthermore, as long as the heating tool can generate heat at a heating temperature of 47°C or less, the lower limit of the air permeation flow rate is also not limited, and is preferably, for example, 10 ml / min or more, more preferably 11.5 ml / min or more, and even more preferably 12 ml / min or more, 12.5 ml / min or more, 13 ml / min or more. The air permeation flow rate is preferably 10 ml / min to 18 ml / min, more preferably 11 ml / min to 17 ml / min, and even more preferably 12 ml / min to 15 ml / min.

[0023] In the present disclosure, the air permeation flow rate of the first packaging material 131 is measured in accordance with JIS K7126-2:2006 "Plastics - Films and sheets - Gas permeability test method - Part 2: Isobaric method" (Annex A). Test piece: The first packaging material 131 is used. Test gas: Air (N ２ :O ２ = 8:2) Measurement conditions: 23±2°C, 50% RH

[0024] Although the present disclosure is not limited to the resin used in the breathable resin film, a preferred example is a thermoplastic resin film. Examples of thermoplastic resins include polyethylene, polypropylene, polyester, polyamide, polyurethane, polystyrene, polyvinyl alcohol, polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, polycarbonate, and ethylene-vinyl acetate copolymer. Preferred examples of resins include polyethylene, polypropylene, polyethylene terephthalate, and ethylene-vinyl acetate copolymer. One type of resin may be used alone, or two or more types may be used in combination.

[0025] The breathable resin film has pores at least partially formed to ensure breathability. The pores are large enough to allow oxygen (air) to pass through at least from the outside to the inside of the storage bag and prevent the exothermic composition 12 from leaking out of the storage bag, so there are no restrictions on the size, shape, number, or method of forming the pores. The resin film preferably has pores that satisfy the air permeation flow rate. Means for forming pores in a resin film are known, and conventional procedures may be followed. Examples of breathable resin films include perforated films and porous films. A porous film is a conventional, general term that refers to a porous film having a large number of pores, each of which is connected to another. The pores may be uniformly formed throughout the entire resin film, or may be densely formed in a portion of the film.

[0026] The thickness of the resin film is not limited as long as it can be used as a packaging material for the storage bag and has breathability. The thickness of the resin film is preferably 10 μm or more and 2000 μm or less, more preferably 10 μm or more and 1000 μm or less, and even more preferably 50 μm or more and 200 μm or less.

[0027] Examples of fiber materials for breathable woven or nonwoven fabrics include semi-synthetic or synthetic fibers such as nylon, vinylon, polyester, rayon, acrylic, polyethylene, polypropylene, acetate, polyvinyl chloride, polybutylene terephthalate, and ethylene-vinyl acetate copolymers; natural fibers such as cotton, hemp, silk, and paper; and any mixed fibers selected from semi-synthetic fibers, synthetic fibers, and natural fibers. From the viewpoint of usability, preferred examples of fiber materials include nylon, polyester, polypropylene, and ethylene-vinyl acetate copolymers, and more preferred examples are nylon, polyester, and ethylene-vinyl acetate copolymers. One type of fiber material may be used alone, or two or more types may be used in combination.

[0028] The woven fabric and nonwoven fabric are not limited as long as they can be used as a packaging material for the storage bag and have breathability, and the basis weight is preferably 10 g / m ２ 80g / m or more ２ The following are examples, and more preferably 20 g / m ２ 70g / m or more ２ The following is an example:

[0029] The thickness of the nonwoven fabric or woven fabric is not limited as long as it can be used as a packaging material for the storage bag and has breathability, and examples of the thickness include preferably 10 μm or more and 2000 μm or less, more preferably 10 μm or more and 1000 μm or less, and even more preferably 50 μm or more and 500 μm or less.

[0030] When the first packaging material 131 is a laminate having the above-described laminated structure, the laminate is not limited as long as it can be used as a packaging material for a storage bag and has breathability. Examples of lamination methods include lamination by thermal bonding, and lamination using any adhesive such as a hot melt adhesive, an acrylic adhesive, or a urethane adhesive. The laminated structure may be formed on the entire surface of the first packaging material 131, or on only a portion of it.

[0031] Second Packaging Material The second packaging material 132 may or may not be breathable. The second packaging material 132 may be the same packaging material as the first packaging material 131, or may be a different packaging material. Therefore, both the first packaging material 131 and the second packaging material 132 may be breathable. Alternatively, the first packaging material 131 may be breathable, and the second packaging material 132 may not be breathable.

[0032] Although this does not limit the present disclosure, for example, both the first packaging material 131 and the second packaging material 132 may be breathable resin films. For example, the first packaging material 131 may be a breathable resin film, and the second packaging material 132 may be a laminate of a breathable resin film and a breathable nonwoven fabric. For example, both the first packaging material 131 and the second packaging material 132 may be laminates. Even when the second packaging material 132 is a laminate having a laminate structure, the laminate structure may be formed over the entire surface of the second packaging material 132, or may be formed over only a portion of the second packaging material 132.

[0033] Although not limiting the present disclosure, for example, both the first packaging material 131 and the second packaging material 132 may be packaging materials with an air permeation flow rate of 18 ml / min or less. As a preferred example, both the first packaging material 131 and the second packaging material 132 may be packaging materials with an air permeation flow rate of 16 ml / min or less. Furthermore, although not limiting the present disclosure, for example, the first packaging material 131 may be a packaging material with an air permeation flow rate of 10 ml / min or more and 18 ml / min or less, and the second packaging material 132 may be a packaging material with an air permeation flow rate of 16 ml / min or less. The air permeation flow rate of the second packaging material 132 is also determined in the same manner as described above. The lower limit of the air permeation flow rate of the packaging material is 0 ml / min. An air permeation flow rate of 0 ml / min means that the packaging material is non-breathable. The air permeation flow rate of the second packaging material 132 can also be adjusted by appropriately changing the size and shape of the pores in the resin film, the basis weight and thickness of the woven fabric or nonwoven fabric, etc.

[0034] Therefore, the air permeation flow rate of the second packaging material 132 is 0 ml / min or more. The air permeation flow rate of the second packaging material 132 is preferably 0 ml / min or more and 18 ml / min or less, more preferably 0 ml / min or more and 17 ml / min or less, more preferably 5 ml / min or more and 16 ml / min or less, and even more preferably 10 ml / min or more and 15 ml / min or less.

[0035] Although not limiting the present disclosure, examples of combinations of the first packaging material 131 and the second packaging material 132 include: (1) a combination in which the first packaging material 131 is a packaging material with an air permeation flow rate of 10 ml / min or more and 18 ml / min or less, and the second packaging material 132 is a packaging material with an air permeation flow rate of 0 ml / min or more and 18 ml / min or less; (2) a combination in which the first packaging material 131 is a packaging material with an air permeation flow rate of 10 ml / min or more and 17 ml / min or less, and the second packaging material 132 is a packaging material with an air permeation flow rate of 5 ml / min or more and 17 ml / min or less; and (3) a combination in which the first packaging material 131 is a packaging material with an air permeation flow rate of 13 ml / min or more and 15 ml / min or less, and the second packaging material 132 is a packaging material with an air permeation flow rate of 10 ml / min or more and 16 ml / min or less.

[0036] Examples of the second packaging material 132 include a resin film, a woven fabric, a nonwoven fabric, and the like. The resin film, the woven fabric, the nonwoven fabric, and the like may be used alone or in combination of two or more types. In the second packaging material 132, the resin film, the woven fabric, the nonwoven fabric, and the like may be joined together as desired or may be laminated to form a laminated structure. When the second packaging material 132 has a laminated structure, similar to the first packaging material 131, the resin film, the woven fabric, the nonwoven fabric, and the like may be arranged in any order and in any number of layers.

[0037] The resin used in the resin film can be described in the same manner as for the first packaging material 131, except that it may or may not be breathable. The size, shape, number, method of forming the pores, and the presence or absence of pores are not limited to the pores that can be formed in the resin film, as long as they prevent leakage of the exothermic composition 12 outside the storage bag. When pores are formed in the resin film of the second packaging material 132, they may be formed uniformly throughout the entire resin film, or may be formed densely in a portion. The thickness of the resin film is also not limited as long as it can be used as a packaging material for the storage bag 13. Examples of thicknesses include preferably 10 μm to 2000 μm, more preferably 10 μm to 1000 μm, even more preferably 50 μm to 500 μm, and even more preferably 100 μm to 300 μm.

[0038] Although the present disclosure is not limited to the woven or nonwoven fiber material, it can be described in the same manner as the first packaging material 131, except that it may or may not have breathability. The basis weight of the woven or nonwoven fabric is also not limited as long as it can be used as a packaging material for the storage bag 13, and is preferably 300 g / m ２ 800g / m or more ２ The following are examples, and more preferably 400 g / m ２ 700g / m or more ２ The thickness of the nonwoven fabric or woven fabric is not limited as long as it can be used as a packaging material for the storage bag 13. Examples of thicknesses include preferably 10 μm or more and 2000 μm or less, more preferably 10 μm or more and 1000 μm or less, even more preferably 50 μm or more and 500 μm or less, and still more preferably 100 μm or more and 300 μm or less.

[0039] At least one of the first packaging material 131 and the second packaging material 132 may be provided with any other layer, such as a vapor deposition layer, a metal foil layer, a printed ink layer, an adhesive layer, or a sealant layer, by lamination or the like, as long as the heating temperature of the heating tool can be kept at 47°C or less. The other layer may be used alone or in combination. Furthermore, the other layer may be provided on a partial surface or the entire surface of at least one of the first packaging material 131 and the second packaging material 132. The means for providing the other layer on the packaging material may be any conventionally known means.

[0040] Although not limiting the present disclosure, examples of components constituting the vapor-deposited layer include metals such as aluminum, chromium, zinc, gold, silver, platinum, and nickel; inorganic oxides such as silicon dioxide, titanium oxide, aluminum oxide, zirconium oxide, and silica; inorganic fluorides such as magnesium fluoride; inorganic nitrides such as titanium nitride; and carbides such as titanium carbide. Vapor-deposited layers containing such components may be used alone or in combination. The thickness, size, shape, and the like of the vapor-deposited layer are not limited. The thickness of the vapor-deposited layer is preferably 1 nm or more to 1000 nm, and more preferably 5 nm or more to 100 nm. The vapor-deposited layer may be laminated, for example, on the inside of the containing bag (the side in contact with the exothermic composition), on the outside of the containing bag, or on both sides. Furthermore, the vapor-deposited layer may be disposed between at least one of the resin film, nonwoven fabric, and woven fabric layers constituting the packaging material. Vapor deposition may be performed based on a conventionally known vapor deposition method.

[0041] Although not limiting the present disclosure, examples of the metal foil layer include an aluminum foil layer and a stainless steel foil layer. The metal foil layer may be used alone or in combination. The thickness of the metal foil layer is preferably 10 nm to 1000 nm, and more preferably 20 nm to 500 nm. The metal foil layer may also be laminated on the inside, outside, or both sides of the storage bag.

[0042] The containment bag 13 contains the exothermic composition 12 in a containment section 14 formed by using a first packaging material and a second packaging material. The containment section 14 is formed by joining the first packaging material 131 and the second packaging material 132 at the periphery of the region of the containment section 14 so that the exothermic composition 12 can be contained in the containment section 14. Preferably, the exothermic composition 12 is contained in the containment section 14, which is a space inside the containment bag, located inside the peripheral joint formed by joining the peripheral edges of the first packaging material 131 and the second packaging material 132. There are no limitations on the joining method as long as the first packaging material 131 and the second packaging material 132 can be joined, and examples include heat sealing (thermal welding using a welding resin, etc.), and a method of laminating them using an adhesive.

[0043] In the present disclosure, the exothermic composition 12 is contained in the container bag 13 and generates heat upon contact with oxygen. The exothermic composition 12 contains an oxidizable metal powder, an oxidation promoter, and a moisture retaining agent.

[0044] Oxidizable Metal Powder The oxidizable metal powder is not limited as long as it is a metal powder that generates heat upon oxidation. Examples include iron powder, zinc powder, aluminum powder, magnesium powder, copper powder, etc., and preferably iron powder. Examples of iron powder include reduced iron powder, cast iron powder, atomized iron powder, electrolytic iron powder, etc. The shape of the oxidizable metal powder is also not limited. Examples include powders such as powders, granules, and fibers that are used in conventional disposable chemical warmers. The oxidizable metal powder may be used alone or in combination of two or more types. The content of the oxidizable metal powder is not limited. Examples of the oxidizable metal powder in the exothermic composition 12 include 20% by mass or more and 80% by mass or less, preferably 25% by mass or more and 70% by mass or less, and more preferably 30% by mass or more and 65% by mass or less.

[0045] Pro-oxidant The pro-oxidant is used to promote the supply of oxygen to the exothermic composition 12, particularly to the oxidizable metal powder, by absorbing oxygen. Examples of pro-oxidants include, but are not limited to, activated carbon, coal, charcoal, bamboo charcoal, graphite, carbon black, graphite, acetylene black, and coffee grounds charcoal. Preferred examples of pro-oxidants include activated carbon, carbon black, bamboo charcoal, charcoal, and coffee grounds charcoal. The shape of the pro-oxidant is also not limited, and examples include powders such as powders, granules, and fibers, which are commonly used in conventional disposable chemical warmers. One type of pro-oxidant may be used alone, or two or more types may be used in combination. The content of the pro-oxidant is not limited, but examples include 1% by mass to 30% by mass, preferably 3% by mass to 25% by mass, and more preferably 5% by mass to 23% by mass, of the exothermic composition 12.

[0046] Furthermore, although not limiting the present disclosure, the ratio of the oxidizable metal powder to the oxidation promoter can be, for example, 2 parts by mass or more and 60 parts by mass or less, preferably 5 parts by mass or more and 50 parts by mass or less, and more preferably 10 parts by mass or more and 40 parts by mass or less, of the oxidation promoter per 100 parts by mass of the oxidizable metal powder.

[0047] Water Retention Agent The water retention agent has the function of retaining water, and examples thereof include porous substances and water-absorbent resins. Examples of water retention agents include natural and synthetic inorganic substances such as vermiculite, perlite, calcium silicate, magnesium silicate, kaolin, talc, smectite, mica, bentonite, calcium carbonate, silica gel, alumina, zeolite, silicon dioxide, and diatomaceous earth, as well as natural and synthetic organic substances such as pulp, wood flour (sawdust), cotton, polyacrylate resins, polysulfonate resins, maleic anhydride resins, polyacrylamide resins, polyvinyl alcohol resins, polyethylene oxide resins, polyaspartate resins, polyglutamate resins, polyalginate resins, starches, and celluloses. Preferred examples of water retention agents include vermiculite, wood flour, pulp, and polyacrylate resins, and more preferably vermiculite and polyacrylate resins. The water retention agents may be used alone or in combination of two or more. The content of the water retention agent is not particularly limited, but is exemplified as 1% by mass or more and 20% by mass or less, preferably 3% by mass or more and 15% by mass or less, and more preferably 5% by mass or more and 10% by mass or less, in the exothermic composition 12. In particular, those having a porous structure such as vermiculite can function not only as a water retention agent but also as a passageway for oxygen (air).

[0048] In addition to the components described above, the exothermic composition 12 may contain, as necessary, other components that can be incorporated into the exothermic composition 12. Examples of such other components include water-soluble salts, water, hydrogen gas generation inhibitors (such as sodium thiosulfate), thickeners, excipients, surfactants, sequestering agents, and the useful components described below. The other components may be selected and used appropriately depending on the purpose, and may be used alone or in combination of two or more types, and the amounts added may also be selected appropriately.

[0049] As an example of other components, water-soluble salts can be described. Examples of water-soluble salts include chloride salts and sulfide salts of alkali metals such as sodium and potassium, chloride salts and sulfide salts of alkaline earth metals such as calcium and magnesium, and chloride salts and sulfide salts of metals such as iron, copper, aluminum, zinc, nickel, silver, and barium. Preferred examples of water-soluble salts include sodium chloride and potassium chloride. These water-soluble salts may be used alone or in combination of two or more. When the exothermic composition 12 contains water-soluble salts, the content of the water-soluble salts in the composition is, for example, 0.1% by mass to 10% by mass, preferably 0.5% by mass to 7% by mass, and more preferably 1% by mass to 5% by mass.

[0050] To explain water as an example of another component, examples of water include distilled water, tap water, ion-exchanged water, pure water, ultrapure water, industrial water, etc. When the exothermic composition 12 contains water, the amount of water in the exothermic composition 12 is, for example, 5% by mass or more and 50% by mass or less, preferably 10% by mass or more and 40% by mass or less, and more preferably 15% by mass or more and 35% by mass or less.

[0051] The exothermic composition 12 is prepared by mixing the above-mentioned ingredients. The exothermic composition 12 may be prepared in the presence of oxygen, or may be prepared under reduced pressure or an inert gas atmosphere. The exothermic composition 12 is preferably prepared under reduced pressure or an inert gas atmosphere. The exothermic composition 12 can be prepared according to a conventionally known procedure for producing exothermic compositions. This preparation results in an exothermic composition 12 that generates heat in the presence of oxygen (air).

[0052] The exothermic composition 12 is contained in the storage bag 13. The amount of exothermic composition 12 contained in the storage bag 13 is not limited as long as the effects of the present disclosure can be obtained, and may be determined appropriately depending on the size, shape, and degree of breathability (air permeability flow rate) of the storage bag 13. For example, ２ The amount of the exothermic composition 12 per unit area is about 0.01 g to 2 g, preferably about 0.05 g to 1.5 g, and more preferably about 0.1 g to 1 g.

[0053] The size, shape, etc. of the storage bag 13 may be determined appropriately depending on the area of ​​the skin where it is to be attached (applied). For example, the area of ​​the first packaging material 131 in the area forming the storage section 14 (inside the storage bag) may be 0.1 cm ２ More than 100cm ２ The following are examples: The area is more preferably 1 cm ２ More than 100cm ２ Below, 2cm ２ More than 50cm ２ Below, 3cm ２ More than 30cm ２ Below, 3cm ２ 20cm or more ２ Below, 3cm ２ Over 15cm ２ For example, in the case of the heating tool shown in the test example described later, the area of ​​the first packaging material 131 in the region forming the storage section 14 is preferably 3 cm ２ Over 9cm ２ Less than 4 cm, more preferably ２ Over 8cm ２ Examples include the following:

[0054] The heating tool of the present disclosure may have one storage section 14, or may have two or more storage sections 14. When it has two or more storage sections 14, typically, each storage section contains an exothermic composition 12. When the heating tool has two or more storage sections 14, the amount of exothermic composition 12 contained in each storage section may be the same or different. Furthermore, when the heating tool has two or more storage sections 13, the size, shape, packaging material forming the storage sections 14, etc. of each storage section may be the same or different.

[0055] Adhesive Layer In the heating tool of the present disclosure, the storage bag 13 may be provided with an adhesive layer. The adhesive layer is usually laminated on the outside of the storage bag 13. The adhesive layer is useful from the viewpoint of easily attaching the storage bag 13 to an object such as skin, clothing, or a heating tool holder. The adhesive layer may be provided on at least one of the first packaging material 131 and the second packaging material 132, as long as it does not interfere with the effects of the present disclosure. Furthermore, the adhesive layer may be provided on a partial surface or the entire surface of at least one of the first packaging material 131 and the second packaging material 132. The means for providing the adhesive layer to the packaging material may follow conventionally known means.

[0056] The adhesive layer typically contains an adhesive that allows the storage bag 13 to be attached to an object. Preferred examples of such adhesives include those that are harmless when applied directly to the skin and are used in conventional patches. Examples of such adhesives include rubber adhesives such as styrene-butadiene-styrene copolymer (SBS), styrene-isoprene-styrene copolymer (SIS), styrene-ethylene-butylene-styrene copolymer (SEBS), and styrene-ethylene-propylene-styrene copolymer (SEPS); acrylic adhesives such as methyl acrylate (MA), ethyl acrylate (EA), 2-ethylhexyl acrylate (HA), and butyl acrylate (BA); silicone adhesives such as addition-curing and peroxide-curing types; and urethane adhesives such as ether and ester types. The adhesives may be used alone or in combination. The amount of adhesive contained in the adhesive layer is not limited as long as the storage bag 13 can be attached to the skin or the like. For example, the content of the adhesive in the adhesive layer is 10% by mass or more and 99% by mass or less, more preferably 30% by mass or more and 98% by mass or less, and even more preferably 50% by mass or more and 97% by mass or less.

[0057] The adhesive layer may further contain optional components such as useful ingredients (fragrances, vitamins, animal and plant extracts, anti-fatigue ingredients, anti-inflammatory ingredients, blood circulation promoting ingredients, relaxing ingredients, refreshing ingredients, repellent ingredients, sedative ingredients, moisturizing ingredients, whitening ingredients, anti-wrinkle ingredients, antibacterial ingredients, antioxidant ingredients, etc.), oils, preservatives, colorants, etc., depending on the purpose, as long as the effects of the present disclosure are not impaired. These optional components may be used alone or in combination, and the content of the optional components may also be determined appropriately.

[0058] Although not limiting to the present disclosure, examples of fragrances include fragrances composed of natural fragrances such as essential oils, either alone or in combination, fragrances composed of synthetic single fragrances, or blended fragrances composed of any combination of natural fragrances and synthetic fragrances. Fragrances may be used alone or in combination of two or more. For example, if the fragrance has an anti-fatigue effect, an anti-inflammatory effect, a blood circulation promoting effect, a relaxing effect, or the like, the fragrance can be used as a useful ingredient such as an anti-fatigue ingredient, an anti-inflammatory ingredient, a blood circulation promoting ingredient, or a relaxing ingredient. In order to more effectively exert the useful effects of the useful ingredients due to the heat generated in the heating tool, it is more preferable that the useful ingredient be a component that can volatilize at 47°C or below, the temperature at which the exothermic composition generates heat in the presence of oxygen (air). The useful ingredient may be liquid, solid, or the like.

[0059] The content of the active ingredient in the adhesive layer may also be appropriately set depending on the desired effect, etc. Although not limiting to the present disclosure, the content of the useful ingredient in the adhesive layer may be, for example, 0.00001% by mass or more and 85% by mass or less, preferably 0.0001% by mass or more and 10% by mass or less, and more preferably 0.0001% by mass or more and 5% by mass or less. The thickness, size, shape, etc. of the adhesive layer may also be appropriately determined depending on the purpose. The thickness of the adhesive layer may, for example, be 1 μm or more and less than 3000 μm, more preferably 10 μm or more and less than 300 μm.

[0060] When an adhesive layer is provided on the storage bag 13, a release sheet may be further attached to the surface of the adhesive layer to prevent the surface of the adhesive layer from drying out. Examples of the release sheet include a film of silicone-treated polyethylene terephthalate, polypropylene, etc., and a sheet of paper, etc. The release sheet is usually peeled off when the heating tool is used.

[0061] As described above, the heating tool of the present disclosure generates heat upon contact with oxygen (air), and is therefore generally provided and stored in an airtight, non-breathable outer bag that does not allow oxygen to pass through. The heating tool of the present disclosure is used by causing the exothermic composition 12 to generate heat upon contact with oxygen. In order to prevent the exothermic composition 12 from generating heat before use, the heating tool is housed in a non-breathable outer bag for the purpose of storing the heating tool without contacting oxygen. When using the heating tool of the present disclosure, the outer bag is opened and the heating tool is removed from the outer bag, and the exothermic composition 12 is brought into contact with oxygen to generate heat. There are no particular limitations on the outer bag, as long as it is a non-breathable bag that does not allow oxygen to pass through.

[0062] Usage, Applications, etc. By using the heating tool, i.e., a heating tool comprising an exothermic composition that generates heat upon contact with oxygen and a storage bag containing the exothermic composition, at least a portion of the storage bag being made of breathable packaging material, and which generates heat at a temperature of 47°C or less, stiffness caused by rheumatoid arthritis or osteoarthritis can be alleviated. Therefore, the heating tool is useful for alleviating stiffness caused by rheumatoid arthritis or osteoarthritis.

[0063] Stiffness caused by rheumatoid arthritis or osteoarthritis makes it difficult to move the body's joints, and it is known that stiffness is particularly felt in joints such as the hands, knees, ankles, and toes. Stiffness in the hands is particularly common. The heating tool of the present disclosure can be worn on a portion of the body's skin. While not limiting the present disclosure, the heating tool of the present disclosure is preferably used for the purpose of relieving hand stiffness. Furthermore, the heating tool of the present disclosure is more preferably used for the purpose of relieving stiffness in the wrist and fingers (difficulty in moving the wrist joints and finger joints). Therefore, the heating tool of the present disclosure is preferably worn on the hand as part of the skin, and more preferably worn on at least one of the wrist and fingers.

[0064] There is also no limit to the time the heating tool of the present disclosure is worn on the skin. Subjects experiencing stiffness due to rheumatoid arthritis or osteoarthritis may experience stiffness continuously throughout the day or intermittently. Stiffness often occurs after sleep, and "morning stiffness," a common early symptom of rheumatoid arthritis or osteoarthritis, is known as difficulty moving the joints upon waking. The heating tool of the present disclosure may be worn by a subject when they are feeling stiff, or when they are not feeling stiff. It is also preferable to wear the heating tool of the present disclosure on a portion of the skin before sleep.

[0065] Furthermore, once stiffness occurs, it often takes time for the stiffness to resolve. For example, morning stiffness often takes from one hour to half a day to resolve. For this reason, from the viewpoint of alleviating the occurrence of morning stiffness and from the viewpoint of not having to wake up to put it on, it is preferable to wear the heating tool of the present disclosure on a part of the skin before going to sleep. Although not limiting the present disclosure, an example of wearing the heating tool before going to sleep is between just before going to sleep and 30 minutes before going to sleep. According to the present disclosure, stiffness can be alleviated. Furthermore, according to the present disclosure, it is expected that stiffness can be prevented from occurring.

[0066] The wearing time of the heating tool of the present disclosure is not limited, and is typically 30 minutes or more, preferably 1 hour to 12 hours. Examples of the wearing time include preferably 2 hours to 12 hours, 3 hours to 11 hours, 4 hours to 10 hours, and 5 hours to 10 hours. Surprisingly, as can be seen from the test examples described below, the heating tool of the present disclosure significantly reduces the risk of low-temperature burns even when used while sleeping. Therefore, the heating tool of the present disclosure can be worn even while sleeping. The heating tool of the present disclosure can be worn for 3 hours or more, preferably 4 hours to 12 hours, or 8 hours to 12 hours.

[0067] The method of attaching the heating tool of the present disclosure is not limited as long as it can be attached to a portion of the subject's skin. The heating tool of the present disclosure may be attached directly or indirectly to the skin. When directly attached, the means is not limited, but from the perspective of easy attachment, a preferred example is to use a heating tool with an adhesive layer and attach the adhesive layer directly to the skin. When indirectly attached, the means is not limited, but from the perspective of easy attachment, a preferred example is to use a heating tool with an adhesive layer and attach the adhesive layer to clothing, bedding, etc., and a preferred example is to attach the heating tool to the skin via clothing, bedding, etc. Furthermore, although not limiting to the present disclosure, a preferred example is to attach the heating tool using a holder capable of holding the heating tool.

[0068] The holder capable of holding the heating tool is not limited as long as it can be attached to a part of the skin and has a holding part capable of holding the heating tool of the present disclosure. Examples of such holders include the holders shown in Figures 2 and 3.

[0069] Fig. 2 shows an example of a holder having a structure provided with a cylindrical main body portion through which the wrist can be inserted and a pocket portion (retaining portion) capable of accommodating the heating tool of the present disclosure. As shown in Fig. 2A, the main body portion has a fixing portion to which a hook-and-loop fastener is attached, and by adjusting the position of the fixing portion attached to the main body portion, the heating tool can be fixed to the wrist joint. Fig. 2B shows an example of the holder attached to the wrist.

[0070] FIG. 3 shows an example of a glove-shaped holder. FIG. 3 shows an example of a holder having a structure covering the wrist, back of the hand, and palm. In FIG. 3, a pocket portion (holding portion) into which a heating tool can be inserted may be provided in the region from the wrist to the back of the hand. In this case, the heating tool is inserted into the pocket for use. The pocket portion may be located on the inside (skin side) of the region from the wrist to the back of the hand, or on the outside of the region. As with typical gloves, the heating tool can be secured to the hand by inserting the hand into the holder. Also, in FIG. 3, the heating tool may be secured to the hand by inserting it between the region of the holder from the wrist to the back of the hand and the back of the hand. In this case, the region of the holder from the wrist to the back of the hand can be referred to as the holding portion. The heating tool may be attached to the holding portion by an adhesive layer provided on the heating tool.

[0071] While Fig. 3 shows an example of a holder that does not cover the fingertips, it may also be a holder that covers the entire tip of at least one finger. Furthermore, while the parts of the finger are usually referred to as the first joint, second joint, and third joint in order from the part closest to the fingertip, this holder may cover, for example, up to the third joint, or even up to the second joint, or even up to the first joint. Furthermore, Fig. 3 shows an example of a holder that has a heating tool holder on the dorsum of the hand, but it may also be a holder that has a heating tool holder on the palm side.

[0072] As described above, the holder of the present disclosure that can hold the heating tool is not limited as long as it can hold the heating tool. For example, it may be provided with a pocket that can accommodate the heating tool, as shown in FIG. 2. Furthermore, when the heating tool is attached to the holder using the adhesive layer, the portion of the holder to which the heating tool is attached can be considered the holding portion. Furthermore, the heating tool may be attached to a portion of the skin by fixing the holder to the body, for example, by wrapping a stretchable holder around the skin, and then placing the heating tool of the present disclosure between the holder and the skin.

[0073] Examples of materials constituting the holder include natural fibers such as cotton, linen, silk, and paper; semi-synthetic or synthetic fibers such as rayon, acetate, nylon, vinylon, polyester, polyurethane, acrylic, polyethylene, polypropylene, polyvinyl chloride, and polybutylene terephthalate; and any blends of these fibers. Preferred examples of such materials include polyester and polyurethane. The thickness of the fabric constituting the holder is not limited. Furthermore, the holder may further include a fastening cord, fastening rubber, hook-and-loop fastener, hooks, buttons, zippers, double-sided tape, etc. for holding the heating device to the body, as needed. A commercially available holder may be used, or a known attachment such as the attachment for a heating / cooling device described in JP 2018-000389 A may be used as the holder.

[0074] The heating tool of the present disclosure is preferably attached to at least the skin of the hand, neck, knee, ankle, toe, etc., and more preferably to the joint. Furthermore, because stiffness caused by rheumatoid arthritis or osteoarthritis often occurs in the hands, the heating tool of the present disclosure is preferably attached to the hand (particularly parts of the hand such as the wrist, back of the hand, palm, and fingers). Therefore, the holder to which the heating tool of the present disclosure is attached is not limited as long as it can be attached to the target skin.

[0075] Therefore, the present disclosure can also be said to provide a heating tool set for relieving stiffness caused by rheumatoid arthritis or osteoarthritis, which includes the heating tool and a holder that is attached to a part of the skin of a subject who has stiffness caused by rheumatoid arthritis or osteoarthritis, and the holder has a holding portion that can hold the heating tool for relieving stiffness.

[0076] In such a set, the heating tool is typically contained in a non-breathable outer bag. The number of heating tools of the present disclosure included in the set is not limited. In addition to the heating tool and holder of the present disclosure, the set may also include instructions for use. The instructions for use may include a webpage URL or a readable code, and instructions for use may be accessible via the URL or readable code. These may be used alone or in combination of two or more.

[0077] The subject (subject) to which the heating tool of the present disclosure is applied may be a human or a non-human mammal, but is typically a human. The subject's age, sex, etc., are also not important, but in the case of humans, an example age is 18 years or older. In the case of humans, an age of 18 years or older and younger than 60 years is preferred, an age of 30 years or older and younger than 60 years is more preferred, and an age of 40 years or older and younger than 60 years is even more preferred. In addition, a preferred example of the subject to which the heating tool is applied is a woman.

[0078] The heating tool of the present disclosure comprises a heat-generating composition that generates heat upon contact with oxygen and a storage bag containing the heat-generating composition, at least a portion of which is made of breathable packaging material, and which generates heat at a temperature of 47°C or less, making it useful for relieving stiffness caused by rheumatoid arthritis or osteoarthritis.

[0079] As mentioned above, stiffness caused by rheumatoid arthritis or osteoarthritis often occurs, especially upon waking, and often in the hands. While paraffin baths and other treatments are known as a typical method for relieving hand stiffness, they have the problem of restricting movement and preventing the use of the fingers during the paraffin bath or while the fingers are covered in paraffin. Furthermore, paraffin baths are generally performed at medical institutions, requiring the patient to visit the facility. Furthermore, once stiffness occurs, it often takes from one hour to half a day for the stiffness to resolve, making it difficult to secure sufficient time for the stiffness to resolve. Morning stiffness, in particular, is difficult to secure from one hour to half a day after waking, causing significant disruption to daily life.

[0080] As shown in the test examples described below, using a heating tool with a heat generation temperature of 47°C or less was able to alleviate stiffness caused by rheumatoid arthritis or osteoarthritis. Furthermore, surprisingly, stiffness caused by rheumatoid arthritis or osteoarthritis was alleviated without causing low-temperature burns, even during sleep. Therefore, the heating tool of the present disclosure has the advantage of being easily usable even at home. In particular, the heating tool of the present disclosure has no limitations on the time of use, and can simply be worn while sleeping. Furthermore, the heating tool of the present disclosure can also alleviate morning stiffness upon waking up or stiff hands. Therefore, the heating tool of the present disclosure has the advantage of being extremely easy to use. Furthermore, the heating tool of the present disclosure has an extremely low risk of low-temperature burns even when used during sleep, making it excellent in terms of safety.

[0081] 2) Skin warming method The present disclosure encompasses a skin warming method that includes the steps of attaching a heating device to a portion of the skin of a subject experiencing stiffness due to rheumatoid arthritis or osteoarthritis, and warming the portion of skin to a temperature of 37°C or higher and 42°C or lower for four hours or more.

[0082] In this method, the subject suffering from stiffness due to rheumatoid arthritis or osteoarthritis is described as above, and the part of the skin to which the heating tool is attached is also described as above.

[0083] The method of the present disclosure requires that a portion of skin be warmed to a temperature of 37°C or higher and 42°C or lower for at least four hours. The heating tool is not limited as long as it can warm a portion of skin to a temperature of 37°C or higher and 42°C or lower for at least four hours, but a preferred example is the heating tool described in 1) above. That is, a preferred example is a heating tool that includes an exothermic composition that generates heat upon contact with oxygen and a storage bag containing the exothermic composition, at least a portion of the storage bag being made of a breathable packaging material, and the heating temperature is 47°C or lower. As mentioned above, the heating tool described in 1) above is usually stored in a non-breathable outer bag until use. Therefore, after removing the heating tool from the outer bag, the heating tool is attached to a portion of skin.

[0084] The method of attaching the heating tool is not limited as long as it can be attached to a part of the subject's skin, and is preferably the same as described above. The heating tool may be attached directly or indirectly to the skin, or may be attached using a holder that can hold the heating tool. Examples of such holders include the holders described above.

[0085] In the present disclosure, whether a portion of skin has been heated to a temperature between 37°C and 42°C for at least four hours is determined as follows: The temperature sensor of a thermometer is attached to a portion of skin with skin tape. Next, a heating tool is attached to the portion of skin so that the heating tool is in direct or indirect contact with the attached temperature sensor, and the skin temperature is recorded. The skin temperature is measured at one-minute intervals.

[0086] Although not limited to this, to explain in more detail using the example of an indirectly attached heating tool, the temperature is determined according to the procedure described in the test below. That is, the temperature sensor of a thermometer (product name: Ondotori TR71-nw, manufacturer: T&D Corporation) is attached to a part of the skin (the outside of the wrist (back of the hand)) with skin tape. Next, with the heating tool placed in the pocket (holding part) of the heating tool holder, the holder is attached to the wrist so that the heating tool touches the temperature sensor via the holder. Skin temperature is measured at 1-minute intervals.

[0087] As shown in the test examples described below, by using the heating tool described in 1) above, a part of the skin can be warmed to a temperature of 37°C or higher and 42°C or lower for 4 hours or more. When using a heating tool other than 1) above, the heating temperature of the heating tool can be appropriately adjusted as needed with reference to the test examples described below, and the heating tool can be selected appropriately. Preferably, the heating temperature, average temperature, duration, etc. of the heating tool are as described above.

[0088] The time for which the heating tool is attached to a part of the skin is not limited, and is typically 4 hours or more. Preferred examples of the attachment time include 4 to 12 hours, 4.5 to 12 hours, 5 to 11 hours, 6 to 10 hours, and 8 to 10 hours. The time can be determined appropriately depending on the time for which the skin is desired to be warmed to a temperature of 37°C to 42°C.

[0089] As mentioned above, stiffness caused by rheumatoid arthritis or osteoarthritis is known to be particularly observed in joints such as the hands, knees, and ankles. Stiffness is particularly common in the hands. Therefore, in order to effectively keep the stiff areas warm, the part of the skin to which the heating device is attached is preferably the skin of the hands, neck, knees, ankles, etc., and more preferably the joints. More preferably, the part of the skin is the hand (particularly parts of the hand such as the wrist, back of the hand, palm, and fingers).

[0090] In this method, as described above, the subject (subject) is not limited, but in the case of humans, the subject is 18 years of age or older. In addition, in the case of humans, the subject is preferably 18 years of age or older but younger than 60 years of age, more preferably 30 years of age or older but younger than 60 years of age, and even more preferably 40 years of age or older but younger than 60 years of age. In addition, the subject is more preferably a woman.

[0091] As mentioned above, subjects who experience stiffness due to rheumatoid arthritis or osteoarthritis may experience stiffness continuously throughout the day or intermittently. Also, "morning stiffness," which is difficulty in moving joints upon waking, is known. In this method, the heating device may be worn by the subject when the subject is experiencing stiffness, or when the subject is not experiencing stiffness. In the heat-retaining method of the present disclosure, it is preferable to wear the heating device before sleep. "Before sleep" is described above.

[0092] The method of the present disclosure involves keeping a portion of a subject's skin, which is stiff due to rheumatoid arthritis or osteoarthritis, warm at a temperature of 37°C or higher and 42°C or lower for at least four hours. Furthermore, as can be seen from the test examples described below, surprisingly, even when a heating device was worn while sleeping and a portion of the skin was heated at a temperature of 37°C or higher and 42°C or lower for at least four hours, the risk of low-temperature burns was reduced. Therefore, the skin warming method of the present disclosure is excellent not only in keeping the skin warm at a predetermined temperature, but also in that it is highly safe and less likely to cause low-temperature burns. Therefore, the skin warming method of the present disclosure can be easily performed at home.

[0093] Hereinafter, the embodiments of the present disclosure will be described more specifically with reference to examples, but the embodiments of the present disclosure are not limited to the following examples.

[0094] Test Example 1: Heating Tool 1. Manufacturing of Heating Tool A heating tool was manufactured according to the following procedure. <Heat-generating Composition> The components were mixed in the amounts shown below to prepare a total of 13.8 g of heat-generating composition: 55% by mass of iron powder (metallic iron content: 90% or more), 27.7% by mass of water, 10.4% by mass of activated carbon (particle size: <250 mesh), 1.9% by mass of vermiculite (particle size: <2.5 mm), 3.2% by mass of water-absorbent resin (water absorption capacity: 180 times or more), 1.7% by mass of water-soluble salts (sodium chloride), and 0.1% by mass of sodium thiosulfate.

[0095] <Storage bag> A breathable porous film (manufactured by Nitoms Corporation, product name Breathlon, thickness: 0.24 mm, laminated structure including resin film and nonwoven fabric) was used as the first packaging material. The air permeation flow rate of the first packaging material was 14.5 ml / min. A non-breathable film (thickness: 73 μm) having the laminated structure shown in Table 1 below was used as the second packaging material. The air permeation flow rate of the second packaging material was 0 ml / min. In this test example, both the first packaging material and the second packaging material were commercially available products, and the air permeation flow rates were the values ​​listed in the catalogs of each packaging material.

[0096]

[0097] In this test example, the air permeation flow rate of the first packaging material and the second packaging material was measured in accordance with JIS K7126-2:2006 "Plastics - Films and sheets - Gas permeability test method - Part 2: Isobaric method" (Appendix A). Test specimens: The first packaging material (breathable porous film) and the second packaging material (non-breathable film) were used. Test gas: Air (N ２ :O ２ = 8:2) Measurement conditions: 23°C, 50% RH

[0098] <Placement of exothermic composition in storage bag> 13.8 g of the obtained exothermic composition was sandwiched between a first packaging material and a second packaging material, and the peripheral edges of the first packaging material and the second packaging material (approximately 3.5 mm from the edge) were heat-sealed to produce a heating tool in which the exothermic composition was stored in a storage bag. The obtained heating tool was stored in an air-impermeable outer bag for the purpose of storing the heating tool without contacting oxygen.

[0099] 2. Evaluation of Heating Characteristics of Heating Tools The heating characteristics (temperature characteristics) of the manufactured heating tools were evaluated in accordance with Japanese Industrial Standard JIS S4100:2007. Specifically, according to the procedure prescribed in JIS S4100:2007, the heating part was covered with a specified underlayment and heating tool holder (in this test example, a heating tool holder was used instead of a covering material), and the temperature was raised to 30°C and maintained within ±1°C. The heating tool (heating tool housed in an outer bag) was left in an atmosphere at the same temperature as the ambient temperature for more than two hours, and then heated according to the usage instructions, and the temperature was measured according to the prescribed procedure (n=10).

[0100] The heating tool holder used in this test example has a cylindrical main body made of polyester and polyurethane, through which the wrist can be inserted, and a pocket (holding portion) for accommodating the heating tool. In this test example, a holder specifically designed for the commercially available product "Kirihai Maki Poka Wrist" was used. A schematic diagram of the holder is shown in Figure 2. As shown in Figure 2, the main body has a fixing portion equipped with a fastening means (hook-and-loop fastener), and the heating tool was fixed to the wrist by contacting the fixing means attached to the fixing portion with the main body. The color, specifications, and uses of the raw materials used in the holder are as shown in Table 2 below. For measuring heating temperature, the thermometer, underlayment, heating tool, and heating tool holder were stacked.

[0101]

[0102] 3. Results The measurement results are shown in Figure 4. Table 3 below shows the maximum heating time of the heating tool, the average temperature while the heating temperature exceeded 40°C, and the duration of heating above 40°C. As per JIS S4100:2007, measurements were taken from immediately after the start of heating until the temperature reached the maximum and dropped below 40°C. The average temperatures in the table were calculated using the following procedure, which conformed to the average temperature evaluation procedure described in the Tokyo Metropolitan Government's guidelines for quality labeling of disposable hand warmers. (a) The temperature characteristics test was conducted using 10 samples (heating tools) as described above. Measurements were taken every 15 minutes from the start of heating and reaching 40°C, passing the maximum temperature, until the temperature returned to 40°C. The maximum and minimum values ​​were excluded for each 15-minute interval. (However, if there were multiple maximum or minimum values, one of the multiple maximum or minimum values ​​was excluded.) After excluding these values, the sum of all remaining measurements (Tsam) was calculated and divided by the number of measurements (NT) to obtain the average temperature (Tav). (B) The test in (A) was carried out for 10 or more lots, and the average value (T-av) of the average temperatures (Tav) was calculated. (C) The average temperature was calculated by rounding off the average value (T-av) calculated in (B) to one decimal place.

[0103]

[0104] As shown in Table 3, the heating temperature of the heating tool (maximum temperature in the table) was 45.8°C, the average temperature during the period when it heated to 40°C or above (average temperature (average (n=10)) in the table) was 44.4°C, and the duration of heating to 40°C or above was 12.7 hours.

[0105] Test Example 2: Skin Warming 1. Test Procedure Just before the subjects (6 people) went to bed, one heating tool manufactured in Test Example 1 was removed from the non-breathable outer bag and placed in the pocket of the heating tool holder used in Test Example 1. The holder was then attached to the skin of the subject's wrist by wrapping it around the skin using a hook-and-loop fastener, and the skin temperature was measured while the subject was sleeping. Temperature measurements were performed as follows.

[0106] <Temperature Measurement Method> The temperature sensor of a thermometer (product name: Ondotori TR71-nw, manufacturer: T&D Corporation) was attached to the outside of the wrist (back of the hand) with skin tape. Next, the heating tool was placed in the pocket (holding portion) of the heating tool holder, and the holder was attached to the wrist so that the heating tool was resting on the temperature sensor via the holder. After attachment, skin temperature was recorded at 1-minute intervals. 2. Results The results are shown in Figure 5. As shown in Figure 5, skin temperature rose approximately 15 minutes after the start of use (attachment) of the heating tool, and the maximum measured skin temperature was 40.8°C for 6 hours. Furthermore, the measured temperature remained between 37°C and 42°C for approximately 6 hours after the start of use of the heating tool. Thus, it was demonstrated that the skin could be kept at a constant temperature. The measured temperature immediately after the start of use of the heating tool was low, below 35°C, but this is thought to be because the heating tool holder had just been attached and was not yet warm.

[0107] Furthermore, no low-temperature burns were observed in this test. It is said that not only temperature but also time is an important factor in low-temperature burns, and traditionally, warnings have been issued against using chemical warmers while sleeping. The results of Test Examples 1 and 2 demonstrated that low-temperature burns can be avoided even while sleeping by setting the maximum heating temperature of the heating tool to 47°C or less. Furthermore, it was found that by using a heating tool with a maximum heating temperature of 47°C or less, it is possible to maintain skin temperature between 37°C and 42°C for 12 hours or more while avoiding low-temperature burns.

[0108] To be safe, the inventors evaluated the risk of low-temperature burns using a conventionally known damage function. Specifically, in 1947, Henriques et al. used the skin of volunteers and pig skin to investigate how long and at what temperature the skin needed to be before it would become burned, and constructed the following damage function:

[0109]

[0110] In the formula, Ω is the damage function, t is the time of skin contact with the heat source (seconds), Tt is the temperature at the base of the epidermis (°C), and Ts is the temperature at the surface of the skin during contact with the heat source (°C). Burns are observed when Ω > 0.53.

[0111] When the damage function of the six subjects in Test Example 2 was calculated using the above formula, the values ​​shown in Table 4 below were obtained. As shown in Table 4, the Ω of each subject was below 0.53. Furthermore, while protein denaturation begins at 42°C, in Test Example 2, the skin temperature did not exceed 42°C during the six hours after the start of use. From these theoretical viewpoints, it was considered that there was little possibility of burns.

[0112]

[0113] The heating device used in this test example was a so-called chemical hand warmer, and it was found that it could keep the skin temperature between 37°C and 42°C while avoiding low-temperature burns even while sleeping.

[0114] Test Example 31. Test Procedure Subjects (15 individuals) with morning finger stiffness due to rheumatoid arthritis were recruited. Starting from the first day of the test (Day 1) until Day 13, each night, the subjects slept without using a heating device and rated the intensity of morning finger stiffness upon waking using an integer value ranging from 0 to 10 (MS score). The subjects also recorded in a diary the duration of morning finger stiffness upon waking and their grip strength (left and right) upon waking. Grip strength was measured immediately after waking using a commercially available grip strength meter. From Day 15 to Day 27, each night, a heating device was attached to the dorsal surface of the wrist (wrist joint, hereinafter referred to as the wrist) during sleep to keep the fingers warm. Upon waking, the heating device was removed, and the intensity of morning finger stiffness was similarly evaluated. The duration and grip strength were also recorded in the diary.

[0115] The heating tool was attached to the wrist by placing the heating tool used in Test Example 1 in the pocket of the holder and wrapping the holder around the skin of the wrist as shown in Figure 2 just before going to bed. The MS score was evaluated on a scale from "0: no stiffness" to "10: most severe stiffness." This evaluation is a conventionally known method for evaluating stiffness.

[0116] Based on the morning stiffness intensity results, the change in mean MS score during the heating device wearing period compared to the heating device non-wearing period was evaluated overall, gender, and age. The duration of morning stiffness and grip strength were also evaluated overall, gender, and age. Furthermore, rheumatoid arthritis disease activity was assessed by physical examination and joint ultrasound at the start (day 1) and end (day 28) of the study. Disease activity was assessed by calculating the DAS28-CRP (Disease Activity Score 28-CRP) from the number of swollen joints (28 joints), the number of tender joints (28 joints), the patient's global assessment (VAS), and CRP (mg / dL) according to commonly used indices and calculation procedures in this field. In addition, the Clinical Disease Activity Index (CDAI) was calculated from the sum of the number of swollen joints (28 joints), the number of tender joints (28 joints), the patient's overall assessment (VAS) (cm), and the physician's overall assessment (VAS) (cm).

[0117] 2. Results Figure 6 shows the results of recording the intensity of morning stiffness (MS score) and duration of morning stiffness. As shown in Figure 6, the average MS scores for all subjects during the period without and with a heating device were 4.47 and 3.83, respectively. A paired t-test showed that the MS scores during the period with a heating device were significantly lower than the MS scores during the period without a heating device. In addition, the duration of stiffness after waking was also lower during the period with a heating device compared to the period without a heating device. Furthermore, no adverse events such as burns were observed due to wearing a heating device while sleeping.

[0118] Table 5 shows the results of evaluation of the intensity of stiffness mentioned above, focusing on the overall population, gender, and age.

[0119]

[0120] As shown in Table 5, the intensity of stiffness was reduced when the heating device was worn compared to when it was not worn. In addition, the group under 60 years old showed a greater reduction in the intensity of stiffness compared to the group over 60 years old. In this test example, age is counted according to the age system.

[0121] Table 6 shows the results of evaluation of the duration of stiffness mentioned above, focusing on the overall population, gender, and age.

[0122]

[0123] As shown in Table 6, the duration of stiffness was shorter when the heating device was worn compared to when it was not worn. In addition, the duration of stiffness was even shorter in the group under 60 years old compared to the group over 60 years old.

[0124] The results of the grip strength measurements taken immediately after waking up are shown in Table 7 (right hand) and Table 8 (left hand).

[0125]

[0126] As shown in Tables 7 and 8, on average, grip strength improved when wearing a heating tool compared to when not wearing one. Furthermore, grip strength improved more in women than in men when wearing a heating tool. Furthermore, grip strength improved in the group under 60 years old, while grip strength remained unchanged (right hand) or decreased (left hand) in the group over 60 years old. This shows that wearing a heating tool improves grip strength overall, and that grip strength can be further improved in women and the group under 60 years old in particular.

[0127] The results and evaluation criteria of the rheumatoid arthritis disease activity assessment (DAS28-CRP) are shown in Tables 9 and 10, respectively. The results of the rheumatoid arthritis disease activity assessment (CDAI) are shown in Tables 11 and 12.

[0128]

[0129]

[0130]

[0131]

[0132] As shown in Tables 9 to 12, DAS28-CRP and CDAI improved after wearing the heating device compared to the period when the heating device was not worn.

[0133] The results of joint echocardiography (joint ultrasound) are shown in Tables 13 and 14. These are the sum of the Gray Scale (Table 13) and Power Doppler Scale (Table 14) scores for a total of 22 joints, including 10 finger joints and wrist joints on both sides, at the start and end of the study.

[0134]

[0135]

[0136] Overall, the Gray Scale and Power Doppler values ​​were lower after wearing the heating tool than before. Also, by gender, the Gray Scale and Power Doppler values ​​were lower in women than in men. Also, the Gray Scale and Power Doppler values ​​were lower in the under-60s group than in the over-60s group.

[0137] These results demonstrate that the use of the heating tool can alleviate stiffness caused by rheumatoid arthritis. Since stiffness caused by rheumatoid arthritis could be alleviated, it can also be understood that stiffness caused by osteoarthritis can be alleviated. Furthermore, no skin symptoms such as dermatitis due to heating with the heating tool were observed during this test. This demonstrates that the heating tool can be worn and used even while sleeping. In particular, few useful means have been known to effectively alleviate morning stiffness or stiff fingers. The above results demonstrate that warming the wrist with a heating tool can significantly improve stiffness in the fingers. Furthermore, it was found that wearing a heating tool while sleeping can significantly improve morning stiffness.

Claims

1. A heating implement for alleviation of stiffness caused by rheumatoid arthritis or osteoarthritis, comprising an exothermic composition that generates heat upon contact with oxygen, and a storage bag that stores the exothermic composition, the storage bag being at least partially made of a breathable packaging material, andthe exothermic temperature being 47°C or lower.

2. The heating implement for alleviation of stiffness according to claim 1, wherein the duration of heat generation to 40°C or higher by the heating implement is 6 hours or more.

3. The heating implement for alleviation of stiffness according to claim 1, wherein the average temperature during heat generation to 40°C or higher by the heating implement is 42°C or higher and 46°C or lower.

4. The heating implement for alleviation of stiffness according to any one of claims 1 to 3, wherein the stiffness is finger stiffness.

5. The heating implement for alleviation of stiffness according to any one of claims 1 to 3, wherein the stiffness is morning stiffness.

6. The heating implement for alleviation of stiffness according to any one of claims 1 to 3, for use in attachment,before sleep, to a portion of the skin of a subject whoexperiences stiffness caused by rheumatoid arthritis or osteoarthritis .

7. The heating implement for alleviation of stiffness according to any one of claims 1 to 3, for use in a subject under 60 years of age who experiences stiffness caused by rheumatoid arthritis or osteoarthritis.

8. A heating implement set for alleviation of stiffness caused by rheumatoid arthritis or osteoarthritis, comprising the heating implement for alleviation of stiffness according to any one of claims 1 to 3, and a holder to be attached to a portion of the skin of a subject who experiences stiffness caused by rheumatoid arthritis or osteoarthritis, the holder having a holding part that can hold the heating implement for alleviation of stiffness.

9. A skin-warming method comprising attaching a heating implement to a portion of the skin of a subject who experiences stiffness caused by rheumatoid arthritis or osteoarthritis to warm the portion of the skin at 37°C or higher and 42°C or lower for 4 hours or more.

10. The method according to claim 9, wherein the stiffness is finger stiffness.

11. The method according to claim 9, wherein the stiffness is morning stiffness.

12. The method according to any one of claims 9 to 11, wherein the heating implement is attached before sleep.

13. 5 The method according to any one of claims 9 to 11,wherein the subject is under 60 years of age.

14. The method according to any one of claims 9 to 11, 10 wherein the heating implement is attached to at least a portion of a hand.

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