WO2020137492A1 - Warming treatment medical device - Google Patents

Warming treatment medical device Download PDF

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Publication number
WO2020137492A1
WO2020137492A1 PCT/JP2019/048102 JP2019048102W WO2020137492A1 WO 2020137492 A1 WO2020137492 A1 WO 2020137492A1 JP 2019048102 W JP2019048102 W JP 2019048102W WO 2020137492 A1 WO2020137492 A1 WO 2020137492A1
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WO
WIPO (PCT)
Prior art keywords
moisture
medical device
permeable sheet
sole
generating part
Prior art date
Application number
PCT/JP2019/048102
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French (fr)
Japanese (ja)
Inventor
孝太 中林
哲也 丸山
Original Assignee
小林製薬株式会社
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Application filed by 小林製薬株式会社 filed Critical 小林製薬株式会社
Priority to CN201980077876.7A priority Critical patent/CN113164279A/en
Publication of WO2020137492A1 publication Critical patent/WO2020137492A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F7/03—Compresses or poultices for effecting heating or cooling thermophore, i.e. self-heating, e.g. using a chemical reaction

Definitions

  • the present invention relates to a medical device for hyperthermia treatment that can impart a thermal effect to the whole body without using a power source.
  • the thermal effect is the effect of warming the body by giving energy from the heat source to the human body, which results in therapeutic effects such as promoting blood circulation, improving fatigue, improving muscle stiffness, and activating gastrointestinal function.
  • various medical devices for hyperthermia treatment for imparting a hyperthermic effect have been developed (for example, Patent Document 1).
  • thermotherapy has a drawback in that it is only possible to locally apply the heating effect to the body, and the effect of applying the heating effect to the entire body is poor.
  • An object of the present invention is to provide a medical device for hyperthermia treatment that can impart a thermal effect to the whole body without using a power source.
  • the present inventor has conducted diligent studies to solve the above-mentioned problems.
  • a heat-generating part containing reduced iron powder as an oxidizing metal is used, and the moisture permeability is 300 to 1200 g/m 2 ⁇ day.
  • the medical device for thermotherapy contained in a container including a sheet by disposing it in at least a part of the sole, a thermal effect is given to the entire body, and not only the sole, but also the hands, feet, It was found that blood circulation is promoted in the whole body such as the shoulder.
  • the present invention has been completed by further studies based on such findings.
  • Item 1 A medical device for hyperthermia which is used by being disposed on at least a part of the sole of the foot, A heat generating part that generates heat that is transferred to the sole of the foot, And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof, The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ⁇ day. Medical device for hyperthermia treatment.
  • Item 2. The medical device for hyperthermia treatment according to Item 1, wherein the exothermic part further contains an oxidation promoter and water.
  • Item 3. Item 3.
  • the medical device for thermotherapy according to Item 1 or 2 wherein the moisture-permeable sheet is a laminated sheet of a breathable resin layer having pores and a fiber base material.
  • Item 4. The medical device for thermotherapy according to any one of Items 1 to 3, wherein an adhesive layer is provided on one surface of the container.
  • Item 5. The medical device for hyperthermia treatment according to any one of Items 1 to 4, which is used for imparting a thermal effect to the entire body. Item 6.
  • the chemical body warmer A heat generating part that generates heat that is transferred to the sole of the foot, And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
  • the heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ⁇ day. Said use. Item 7.
  • thermotherapy method comprising the step of disposing a chemical warmer on at least a part of the sole of a person who requires hyperthermia,
  • the chemical body warmer A heat generating part that generates heat that is transferred to the sole of the foot,
  • the heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ⁇ day.
  • the medical device for hyperthermia of the present invention by applying to the sole of the foot, it is possible to promote blood circulation in the hands, feet, shoulders, etc., and it is possible to impart a heating effect to the whole body, and to cool the whole body. Improvement, swelling improvement, fatigue recovery, muscle pain relief, joint pain relief, immunity enhancement, muscle stiffness relief, etc. become possible. Further, the medical device for hyperthermia treatment of the present invention does not require an electric power source to impart the thermal effect, and therefore is excellent in convenience and versatility.
  • A is a schematic plan view of the moisture-permeable sheet and the moisture-impermeable sheet used in the test example.
  • B is the schematic which planarly viewed the medical device for thermotherapy manufactured in the test example.
  • FIG. 3A is a schematic view of the sticking sample used in the test example as seen from the side of the medical device for thermotherapy.
  • B is the schematic diagram which planarly viewed from the double-sided tape side the sticking sample used in the test example.
  • the medical device for thermotherapy of the present invention is a medical device for thermotherapy which is used by being disposed on at least a part of a sole, and a heat generating part for generating heat transferred to the sole, and the heat generating part. And a container containing a moisture permeable sheet on at least one surface thereof, the heat generating portion contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ⁇ day. It is characterized by being a chemical warmer.
  • the medical device for thermotherapy of the present invention will be described in detail.
  • the medical device for hyperthermia treatment of the present invention has a heat generating portion containing reduced iron powder in order to generate heat transferred to the sole.
  • reduced iron powder as an oxidizable metal that generates heat of oxidation by contact with oxygen, and by using a container having a specific moisture permeability described later, it is arranged on at least a part of the sole. When used, it becomes possible to give a thermal effect to the whole body.
  • the “heat-generating part” is a part that generates heat to be transmitted to the sole of the foot, and is composed of a heat-generating composition containing an oxidizable metal and other components that are optionally mixed.
  • ⁇ Reduced iron powder is powdered iron produced by reducing iron compounds such as iron oxide and iron salts with hydrogen.
  • the range of the particle size of the reduced iron powder used in the present invention is not particularly limited, but examples thereof include more than 10 ⁇ m and 800 ⁇ m or less. From the viewpoint of further improving the heating effect on the whole body, the particle size of the reduced iron powder is preferably more than 10 ⁇ m and 500 ⁇ m or less, and more preferably more than 10 ⁇ m and 300 ⁇ m or less. In the present invention, the range of the particle size of the reduced iron powder is a value determined according to the method specified in the Japanese Industrial Standard “JIS 8815-1994 General Rules for Sifting Test Method”.
  • the apparent density of the reduced iron powder used in the present invention is not particularly limited, but is, for example, 1.0 to 4.0 g/cm 2 , preferably 1.5 to 4.0 g/cm 2 , and more preferably 2.0 to 4.0 g/cm 2 can be mentioned.
  • the apparent density is a value determined according to the method specified in Japanese Industrial Standard “JIS Z 2504:2012 Metal powder-Apparent density measuring method”.
  • the content of the reduced iron powder in the heat generating part is, for example, 20 to 80% by weight, preferably 25 to 70% by weight, more preferably 30 to 60% by weight.
  • the heat generating part may contain an oxidation promoter for holding oxygen and for promoting oxygen supply to the reduced iron powder.
  • the type of the oxidation promoter is not particularly limited as long as it is capable of retaining oxygen and supplying oxygen to the reduced iron powder, but examples thereof include activated carbon, carbon black, acetylene black, bamboo charcoal, charcoal, coffee ground charcoal. , Carbon materials such as graphite, coal, coconut shell charcoal, calendar blue coal, peat and lignite. These oxidation promoters may be used alone or in combination of two or more.
  • activated carbon preferred are activated carbon, carbon black, bamboo charcoal, charcoal, coffee dust charcoal, and more preferably activated carbon.
  • the shape of the oxidation promoter is not particularly limited, but from the viewpoint of heat generation efficiency, it is preferably powdery, granular or fibrous, and more preferably powdery.
  • the content of the oxidation promoter in the heat generating part is not particularly limited, but is, for example, 1 to 30% by weight, preferably 3 to 25% by weight, more preferably 5 to 23% by weight. %.
  • the heat generating part contains water in order to accelerate the oxidation reaction of the reduced iron powder.
  • water any of distilled water, ion-exchanged water, pure water, ultrapure water, tap water, industrial water, etc. may be used.
  • the content of water in the heat-generating part is not particularly limited, but is, for example, 5 to 50% by weight, preferably 10 to 40% by weight, more preferably 15 to 35% by weight. ..
  • the heat generating part may contain a water retention agent in order to retain water and efficiently supply water to the oxidation reaction field.
  • the type of the water retention agent is not particularly limited, but for example, vermiculite (calculus), perlite, calcium silicate, magnesium silicate, kaolin, talc, smectite, mica, bentonite, calcium carbonate, silica gel, alumina, zeolite, dioxide.
  • Inorganic porous materials such as silicon and diatomaceous earth; organic substances such as pulp, wood powder (sawdust), cotton, starches, celluloses; polyacrylic acid resins, polysulfonic acid resins, maleic anhydride resins, polyacrylamide resins
  • water absorbent resins such as polyvinyl alcohol resins, polyethylene oxide resins, polyaspartic acid resins, polyglutamic acid resins, and polyalginic acid resins.
  • water retention agents preferably vermiculite, polyacrylic acid-based resin, wood powder, pulp; more preferably vermiculite, polyacrylic acid-based resin. Further, when an inorganic porous material is used as the water retention agent, it becomes possible to secure an air flow path in the exothermic composition.
  • the content of the water retention agent in the heat generating part is not particularly limited, but is, for example, 1 to 20% by weight, preferably 3 to 15% by weight, and further preferably Is 3 to 7% by weight.
  • the exothermic part may contain water-soluble salts in order to accelerate the oxidation reaction of the reduced iron powder.
  • the type of water-soluble salt is not particularly limited, but examples thereof include alkali metals (sodium, potassium, etc.), alkaline earth metals (calcium, magnesium, etc.), or heavy metals (iron, copper, aluminum, zinc, nickel, silver, Sulfates, hydrogen carbonates, chlorides or hydroxides of barium).
  • chlorides such as sodium chloride, potassium chloride, calcium chloride, magnesium chloride, iron chloride (first and second) are more preferable, from the viewpoints of conductivity, chemical stability, and the like, and further preferable.
  • Examples include sodium chloride.
  • These water-soluble salts may be used alone or in combination of two or more.
  • the content of the water-soluble salt in the heat-generating part is not particularly limited, but is, for example, 0.1 to 10% by weight, preferably 0.5 to 7% by weight, and more preferably 0.5 to 5% by weight.
  • additives such as a metal to be oxidized other than the reduced iron powder, a sequestering agent, a fragrance, a thickener, an excipient, a surfactant, a hydrogen generation inhibitor, etc. may be added. May be included.
  • the exothermic composition used as the exothermic part can be prepared by mixing the above-mentioned components in predetermined amounts.
  • the exothermic composition used as the exothermic part may be prepared in the presence of oxygen, but is preferably prepared under reduced pressure or in an inert gas atmosphere.
  • the amount of the heat-generating part accommodated in each container may be appropriately set within the range applicable to the sole, but is preferably 5 to 30 g, preferably Is 10 to 20 g, more preferably 12 to 18 g.
  • the medical device for hyperthermia treatment of the present invention has a container for housing the heat generating portion.
  • the container is a moisture permeable sheet having a moisture permeability of 300 to 1200 g/m 2 ⁇ day on at least one surface in order to supply oxygen and water vapor to the heat generating portion during use. have.
  • the moisture permeability of the moisture-permeable sheet used in the present invention may be 300 to 1200 g/m 2 ⁇ day. It is preferably 650 to 1200 g/m 2 ⁇ day, more preferably 680 to 1150 g/m 2 ⁇ day, and particularly preferably 700 to 1100 g/m 2 ⁇ day.
  • the water vapor transmission rate is measured under the conditions of a temperature of 40° C. and a humidity of 90% RH by the method specified in Japanese Industrial Standard “JIS Z0208-1975 Moisture vapor transmission test method (cup method) for moisture-proof packaging materials. It is a value.
  • the material of the moisture-permeable sheet is not particularly limited as long as it has the moisture permeability, but it is preferable that it is formed of at least a breathable resin layer (resin layer having pores) to improve the usability. From this point of view, a laminated sheet of a breathable resin layer and a fiber base material is more preferable. In the laminated sheet of the air-permeable resin layer and the fiber base material, the air-permeable resin layer and the fiber base material may be laminated in this order from the inside to the outside of the container.
  • the constituent resin of the gas permeable resin layer is not particularly limited, and examples thereof include polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polyacrylonitrile, ethylene-vinyl alcohol copolymer, polyamide, polyurethane, polystyrene, polyvinyl.
  • examples thereof include alcohol, polyvinyl chloride, polyvinylidene chloride, and polycarbonate.
  • polyethylene, polypropylene and ethylene vinyl acetate copolymer are preferable.
  • the breathable resin layer may be a resin film provided with pores for ensuring breathability.
  • the shape, size and number of the pores provided in the resin film may be appropriately set according to the moisture permeability to be provided in the container.
  • the thickness of the breathable resin layer may be appropriately set according to the layer structure of the moisture permeable sheet, and is, for example, 15 to 150 ⁇ m, preferably 30 to 100 ⁇ m, and more preferably 50 to 80 ⁇ m.
  • the fiber base material used for the moisture permeable sheet include non-woven fabric and woven fabric. From the viewpoint of usability, a non-woven fabric is preferable.
  • the material of the fiber base material 232 is not particularly limited, but for example, synthetic fibers such as polyethylene terephthalate, polybutylene terephthalate, nylon, polypropylene, polyethylene, vinylon, rayon, acrylic, acetate, polyvinyl chloride; cotton, hemp, silk. , Natural fibers such as paper; and mixed fibers thereof.
  • synthetic fibers such as polyethylene terephthalate, polybutylene terephthalate, nylon, polypropylene, polyethylene, vinylon, rayon, acrylic, acetate, polyvinyl chloride; cotton, hemp, silk.
  • Natural fibers such as paper; and mixed fibers thereof.
  • polyethylene terephthalate, nylon and polypropylene are preferable, and polyethylene terephthalate and nylon are more preferable, from the viewpoint of enhancing the feeling of use.
  • the basis weight of the fibrous base material may be appropriately set according to the layer structure of the moisture-permeable sheet and the like, but is, for example, 1 to 100 g/m 2 , preferably 5 to 70 g/m 2 , and more preferably 10 to 50 g/m 2 . m 2 may be mentioned.
  • the air-permeable resin layer and the fiber base material can be laminated by a known laminating method such as dry laminating, extrusion laminating or heat laminating.
  • the container used in the present invention may include the moisture-permeable sheet on at least one surface.
  • the container used in the present invention preferably has a shape having two surfaces, a surface arranged on the sole side and a surface arranged on the opposite side. In the case of having the shape, the entire surface may be formed of the moisture permeable sheet, and one surface is the moisture permeable sheet, and the other surface is a low moisture permeable sheet (hereinafter referred to as “non-moisture permeable sheet”). May be described).
  • the moisture permeability of the moisture-impermeable sheet for example 10g / m 2 ⁇ day or less, preferably 5g / m 2 ⁇ day or less, more preferably 2g / m 2 ⁇ day or less, more preferably 1g / m 2 ⁇ day Below, 0 g/m 2 ⁇ day is particularly preferable.
  • the material of the non-moisture permeable sheet is not particularly limited, but a resin sheet having no pores is preferable.
  • the constituent resin of the resin sheet constituting the non-moisture permeable sheet is not particularly limited, and examples thereof include polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polyacrylonitrile, ethylene-vinyl alcohol copolymer, polyamide, Examples thereof include polyurethane, polystyrene, polyvinyl alcohol, polyvinyl chloride, polyvinylidene chloride, and polycarbonate.
  • polyethylene, polypropylene and ethylene vinyl acetate copolymer are preferable.
  • the thickness of the resin sheet forming the non-moisture permeable sheet may be appropriately set according to the layer structure of the non-moisture permeable sheet, and is, for example, 115 to 250 ⁇ m, preferably 130 to 200 ⁇ m, more preferably 150 to 180 ⁇ m can be mentioned.
  • the non-moisture permeable sheet may have a fiber base material laminated on a resin sheet having no pores, if necessary.
  • the material and basis weight of the fiber base material used in the non-moisture permeable sheet are the same as those exemplified for the moisture permeable sheet.
  • one surface of the container is preferably provided with an adhesive layer so that it can be fixed to the sole of the foot when used.
  • an adhesive layer is provided on the surface of one moisture permeable sheet, and one surface is a moisture permeable sheet, and the other surface is When formed of a non-moisture permeable sheet, an adhesive layer may be provided on the surface of the non-moisture permeable sheet.
  • the adhesive layer may be provided on the entire one surface of the container, or may be partially provided on one surface of the container.
  • the adhesive layer can be formed using an adhesive.
  • the adhesive includes a polymer (adhesive polymer) that exhibits adhesiveness in the presence of an oil agent or other solvent, and the adhesive polymer is dispersed or dissolved in the oil agent or other solvent to exhibit adhesiveness.
  • the composition The type and composition of the adhesive polymer contained in the adhesive are known, and in the present invention, the adhesive used in the adhesive layer of the conventional disposable body warmer can be used. Specific examples of the type of adhesive include rubber-based adhesives, acrylic-based adhesives, silicone-based adhesives, urethane-based adhesives, and the like.
  • the coating amount of the adhesive layer is, for example, 5 to 40 g/m 2 , preferably 10 to 30 g/m 2 , and more preferably 15 to 25 g/m 2 .
  • a release layer capable of releasing may be provided on the outer surface of the adhesive layer.
  • the release layer it is possible to prevent the adhesive layer from being dried during storage and prevent the handling property from being deteriorated due to the adhesion of the adhesive layer.
  • the release layer examples include resin films such as polyethylene terephthalate, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and polypropylene; paper that has been subjected to a release property imparting treatment such as silicone processing. Further, even when the resin film is used as the release layer, the release property imparting process such as silicone process may be applied.
  • the container has a shape composed of two surfaces, a surface arranged on the sole side and a surface arranged on the opposite side, the two moisture-permeable sheets or the one moisture-permeable sheet and the one sheet It is formed by sticking one non-moisture permeable sheet around the area for accommodating the heat generating portion.
  • the method for laminating the two moisture-permeable sheets or the one moisture-permeable sheet and the one non-moisture permeable sheet is not particularly limited, but, for example, the moisture-permeable resin or the non-moisture permeable sheet may be attached to the heat-welding resin.
  • the ends may be heat-welded (heat-sealed) by using the heat-fusible resin, or the ends may be bonded by using an adhesive.
  • the shape of the container may be set so that it can be disposed on at least a part of the bottom of the foot, and may be appropriately set according to the part of the foot to be applied.
  • the shape in plan view extends from the linear end side in one direction.
  • a shape in which the other end side is circular is mentioned.
  • the surface of the container disposed on the side of the sole may be provided with a concave portion or a convex portion so as to follow the shape of the sole. ..
  • the area of the portion that accommodates the heat generating portion in the container is, for example, 20 to 180 cm 2 , preferably 30 to 70 cm 2 , and more preferably 35-60 cm 2 can be mentioned.
  • the medical device for hyperthermia treatment of the present invention is packaged in a packaging material having an oxygen barrier property and provided without contact with air. By disposing it on at least a part of the sole during use, the heat generating part comes into contact with the air and heat generation starts.
  • the medical device for hyperthermia treatment of the present invention is used by being disposed on at least a part of the sole.
  • the medical device for hyperthermia of the present invention can be locally applied to at least a part of the sole of the foot to impart a heating effect to the whole body such as hands, feet, and shoulders.
  • the medical device for hyperthermia of the present invention can impart a thermal effect to the whole body, it promotes blood circulation in the whole body, improves coldness, improves tiredness, improves muscle stiffness, and activates gastrointestinal function. It can be used for the purpose of immunostimulation.
  • the medical device for hyperthermia treatment of the present invention may be used by directly fixing it to the skin on the sole of the foot, or by fixing it to the sole of the foot while wearing socks. Further, the medical device for thermotherapy of the present invention can be used by fixing it to the insole of shoes or slippers and putting on the shoes or slippers.
  • the site of the plantar part to which the medical device for hyperthermia treatment of the present invention is applied is not particularly limited, and examples thereof include the back of the toes, the base of the back of the toes, the arch, the small flexor flexor portion, and the heel.
  • the medical device for hyperthermia treatment of the present invention may be designed so as to be arranged on at least a part of the sole of the foot, and for example, together with a part of the bottom of the foot, a front part of a toe or a foot It may be designed so as to be arranged also on at least a part of the instep.
  • the part of the sole of the foot where the medical device for thermotherapy of the present invention is arranged, preferably at least the base part of the back of the toes, more preferably the foot. At least a part of the back of the toes and the base of the back of the toes, and particularly preferably, the sole of the region from about 0 to 1 cm from the tip of the middle toe to about 9 to 20 cm toward the heel side.
  • the moisture-permeable sheets A to F having various moisture permeability shown in Table 1 were prepared .
  • the shape of each moisture permeable sheet is as shown in FIG.
  • the moisture permeability of each moisture permeable sheet is measured under the conditions of temperature 40° C. and humidity 90% RH by the method specified in Japanese Industrial Standard “JIS Z0208-1975 moisture proof packaging material moisture permeability test method (cup method)”.
  • a spunlace nonwoven fabric made of polyethylene terephthalate weight per unit area: 30 g/m 2
  • a polyethylene film thickness 60 ⁇ m
  • a non-moisture permeable sheet (thickness 159 ⁇ m) having a moisture permeability of 0 g/m 2 ⁇ day was prepared.
  • the shape of the moisture impermeable sheet is as shown in A of FIG.
  • a pressure-sensitive adhesive was applied to one surface of the non-moisture permeable sheet at a rate of 21 g/m 2, and then a release sheet was laminated.
  • the iron powder A was prepared by classifying iron powder (“MR2” (manufactured by Dowa Iron Powder Industry Co., Ltd.) with a mesh having an opening of 180 ⁇ m, and collecting the iron powder remaining on the mesh.
  • B was prepared by classifying iron powder (“MR2”, (manufactured by Dowa Iron Powder Industry Co., Ltd.) with a mesh having an opening of 45 ⁇ m, and collecting the iron powder that passed through the mesh.
  • Powder (“80AF”, (manufactured by Kobe Steel, Ltd.) was used.
  • iron powder D the iron powder (“80AF”, (manufactured by Kobe Steel, Ltd.) was classified by a mesh having an opening of 180 ⁇ m, and the mesh was used. It was prepared by recovering the iron powder remaining in No. 1. The apparent density was measured by the method specified in Japanese Industrial Standards "JIS Z 2504:2012 Metal powder-Apparent density measuring method".
  • An exothermic composition having the composition shown in Table 3 was prepared using each of the iron powders and used as a heating element.
  • the non-woven fabric side of the moisture permeable sheet and the pressure-sensitive adhesive layer laminated on the non-moisture permeable sheet were arranged such that they were on the outside, and the prepared heating element 13g was sandwiched between the moisture permeable sheet and the non-moisture permeable sheet. ..
  • the peripheral edge portion (width 0.5 cm) of both sheets is heat-welded so as to be as shown in FIG. 2B in a plan view, and a medical device for thermotherapy having a heating element housed in the housing portion. It was manufactured (the black line portion surrounding the periphery in B of FIG.
  • the peripheral portion which is heat-sealed is the peripheral portion which is heat-sealed).
  • the area of the part that accommodates the heat generating portion (the area of the part that accommodates the heat generating portion in plan view) is 57 cm 2 .
  • the medical device for hyperthermia treatment that was manufactured was quickly housed and sealed in a gas-impermeable sealed bag.
  • the combinations of the moisture-permeable sheet and the iron powder used in the heating element in the manufactured medical device for thermotherapy are as shown in Table 4.
  • the portion of the apex X shown in FIG. 3A is located 1 cm from the tip of the middle finger of the left sole from the heel, and the apex X is on the finger side and the end side Y is on the heel side.
  • the sample for sticking was stuck to the region of the base from the back of the toes through the tape, and the state was maintained for 60 minutes.
  • blood flow blood after attachment
  • the foot the ankle part of the right foot
  • the hand the back part of the right shoulder
  • the shoulder the back part of the right shoulder
  • Flow was measured with a Doppler blood flow meter.
  • the amount of change in blood flow after use was calculated by subtracting the value of blood flow before application from the value of blood flow after application.
  • the attachment site of the attachment sample was changed to the heel of the left sole, and blood flow was measured by the same method.
  • the apex X shown in FIG. 3A is arranged on the apex side of the heel and the end side Y is arranged on the toe side.
  • the attachment site of the attachment sample was changed to the left shoulder, and blood flow was measured by the same method.
  • the sticking sample is stuck to the left shoulder
  • the apex X shown in FIG. 3A is arranged on the neck side of the left shoulder and the end side Y is arranged on the left arm side.

Abstract

The purpose of the present invention is to provide a warming treatment medical device which is capable of imparting a warming effect to the whole body without using a power source.　This warming treatment medical device uses a heating part that contains a reducing iron powder as an oxidizable metal, the heating part being housed in a housing body that includes a moisture permeable sheet which has a moisture permeability of 300 to 1200 g/m2∙day. When the warming treatment medical device is used while being arranged at least at a portion of the soles of the feet, a warming effect is imparted to the whole body and blood circulation is promoted not only in the soles of the feet but also the entire body including the hands, legs, and shoulders.

Description

温熱治療用の医療機器Medical equipment for hyperthermia
　本発明は、電力源を使用せずに全身に温熱効果を付与できる温熱治療用の医療機器に関する。 The present invention relates to a medical device for hyperthermia treatment that can impart a thermal effect to the whole body without using a power source.
　温熱効果とは、人体に熱源によるエネルギーを与えて身体を温める効果であり、それにより血行の促進、疲労感の改善、筋肉のコリの改善、胃腸の働きの活発化等の治療効果がもたらされることが分かっている。従来、温熱効果を付与するための温熱治療用の医療機器が種々開発されている（例えば、特許文献１等）。 The thermal effect is the effect of warming the body by giving energy from the heat source to the human body, which results in therapeutic effects such as promoting blood circulation, improving fatigue, improving muscle stiffness, and activating gastrointestinal function. I know that. Conventionally, various medical devices for hyperthermia treatment for imparting a hyperthermic effect have been developed (for example, Patent Document 1).
　しかしながら、従来の温熱治療用の医療機器では、電力源を必要とされるものが多数であり、利便性や汎用性に欠けるという欠点がある。また、従来の温熱治療用の医療機器では、身体に対して局所的に温熱効果を付与できるに止まり、体全体に対して温熱効果を付与する効果が乏しいという欠点もある。 However, there are many conventional medical devices for hyperthermia that require a power source, and they lack the convenience and versatility. In addition, the conventional medical device for thermotherapy has a drawback in that it is only possible to locally apply the heating effect to the body, and the effect of applying the heating effect to the entire body is poor.
　近年、温熱効果を全身に及ぼすことにより、温熱による治療効果を向上させ、更には免疫賦活効果も向上させ得るという知見が見出されている。しかしながら、体全体に対して温熱効果を付与するには、入浴等の利便性に欠ける手段をとらざるをえないのが現状である。 In recent years, it has been found that by exerting a thermal effect on the whole body, the therapeutic effect by the heat can be improved and further the immune activating effect can be improved. However, in order to give a heating effect to the whole body, it is the current situation that it is inevitable to take a means such as bathing which is not convenient.
特開２００９－２６８６７号公報JP, 2009-26867, A
　本発明の目的は、電力源を使用せずに全身に温熱効果を付与できる温熱治療用の医療機器を提供することである。 An object of the present invention is to provide a medical device for hyperthermia treatment that can impart a thermal effect to the whole body without using a power source.
　本発明者は、前記課題を解決すべく鋭意検討を行ったところ、酸化性金属として還元鉄粉を含む発熱部を使用し、これを透湿度が３００～１２００ｇ／ｍ2・ｄａｙである透湿性シートを含む収容体に収容した温熱治療用の医療機器を足底部の少なくとも一部に配設して使用することにより、体全体に温熱効果が付与され、足底部のみならず、手、足、肩等の全身において血行が促進されることを見出した。本発明は、かかる知見に基づいて、更に検討を重ねることにより完成したものである。 The present inventor has conducted diligent studies to solve the above-mentioned problems. As a result, a heat-generating part containing reduced iron powder as an oxidizing metal is used, and the moisture permeability is 300 to 1200 g/m 2 ·day. By using the medical device for thermotherapy contained in a container including a sheet by disposing it in at least a part of the sole, a thermal effect is given to the entire body, and not only the sole, but also the hands, feet, It was found that blood circulation is promoted in the whole body such as the shoulder. The present invention has been completed by further studies based on such findings.
　即ち、本発明は、下記に掲げる態様の発明を提供する。
項１．　足底部の少なくとも一部に配設して使用される温熱治療用の医療機器であり、
　足底部に伝える熱を発生させる発熱部と、
　前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体と、を有し、
　前記発熱部が還元鉄粉を含み、且つ
　前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである、
温熱治療用の医療機器。
項２．　発熱部が、更に酸化促進剤及び水を含む、項１に記載の温熱治療用の医療機器。
項３．　前記透湿性シートが、細孔を有する通気性樹脂層と繊維基材との積層シートである、項１又は２に記載の温熱治療用の医療機器。
項４．　前記収容体の一方の面に粘着層が設けられている、項１～３のいずれかに記載の温熱治療用の医療機器。
項５．　体全体に対して温熱効果を付与するために使用される、項１～４のいずれかに記載の温熱治療用の医療機器。
項６．　足底部の少なくとも一部に配設して使用される温熱治療用の医療機器の製造のための、化学カイロの使用であって、
　前記化学カイロが、
　足底部に伝える熱を発生させる発熱部と、
　前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体と、を有し、
　前記発熱部が還元鉄粉を含み、且つ
　前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである、
前記使用。
項７．　温熱治療が必要とされる者の足底部の少なくとも一部に化学カイロを配設する工程を含む温熱治療方法であって、
　前記化学カイロが、
　足底部に伝える熱を発生させる発熱部と、
　前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体と、を有し、
　前記発熱部が還元鉄粉を含み、且つ
　前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである、
温熱治療方法。 That is, the present invention provides the inventions of the following modes.
Item 1. A medical device for hyperthermia which is used by being disposed on at least a part of the sole of the foot,
A heat generating part that generates heat that is transferred to the sole of the foot,
And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day.
Medical device for hyperthermia treatment.
Item 2. Item 2. The medical device for hyperthermia treatment according to Item 1, wherein the exothermic part further contains an oxidation promoter and water.
Item 3. Item 3. The medical device for thermotherapy according to Item 1 or 2, wherein the moisture-permeable sheet is a laminated sheet of a breathable resin layer having pores and a fiber base material.
Item 4. Item 4. The medical device for thermotherapy according to any one of Items 1 to 3, wherein an adhesive layer is provided on one surface of the container.
Item 5. Item 5. The medical device for hyperthermia treatment according to any one of Items 1 to 4, which is used for imparting a thermal effect to the entire body.
Item 6. Use of a chemical warmer for the manufacture of a medical device for hyperthermia, which is used by being disposed on at least a part of the sole,
The chemical body warmer
A heat generating part that generates heat that is transferred to the sole of the foot,
And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day.
Said use.
Item 7. A thermotherapy method comprising the step of disposing a chemical warmer on at least a part of the sole of a person who requires hyperthermia,
The chemical body warmer
A heat generating part that generates heat that is transferred to the sole of the foot,
And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day.
Heat treatment method.
　本発明の温熱治療用の医療機器によれば、足底部に適用することによって、手、足、肩等の血行の促進が可能になっており、体全体に温熱効果を付与でき、全身の冷え性改善、むくみ改善、疲労回復、筋肉の痛み緩和、関節痛の緩和、免疫向上、筋肉のコリほぐし等が可能になる。また、本発明の温熱治療用の医療機器は、温熱効果を付与するのに電力源を必要としないため、利便性や汎用性の点でも優れている。 According to the medical device for hyperthermia of the present invention, by applying to the sole of the foot, it is possible to promote blood circulation in the hands, feet, shoulders, etc., and it is possible to impart a heating effect to the whole body, and to cool the whole body. Improvement, swelling improvement, fatigue recovery, muscle pain relief, joint pain relief, immunity enhancement, muscle stiffness relief, etc. become possible. Further, the medical device for hyperthermia treatment of the present invention does not require an electric power source to impart the thermal effect, and therefore is excellent in convenience and versatility.
本発明で使用される収容体の一態様について平面視した概略図である。It is the schematic which planarly viewed about one aspect of the container used by this invention. Ａは、試験例で使用した透湿性シートと非透湿性シートを平面視した概略図である。Ｂは、試験例で製造した温熱治療用の医療機器を平面視した概略図である。A is a schematic plan view of the moisture-permeable sheet and the moisture-impermeable sheet used in the test example. B is the schematic which planarly viewed the medical device for thermotherapy manufactured in the test example. Ａは、試験例で使用した貼り付け用サンプルを温熱治療用の医療機器側から平面視した概略図である。Ｂは、試験例で使用した貼り付け用サンプルを両面テープ側から平面視した概略図である。FIG. 3A is a schematic view of the sticking sample used in the test example as seen from the side of the medical device for thermotherapy. B is the schematic diagram which planarly viewed from the double-sided tape side the sticking sample used in the test example.
　本発明の温熱治療用の医療機器は、足底部の少なくとも一部に配設して使用される温熱治療用の医療機器であって、足底部に伝える熱を発生させる発熱部と、前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体とを有し、前記発熱部が還元鉄粉を含み、且つ前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである化学カイロであるを特徴とする。以下、本発明の温熱治療用の医療機器について詳述する。 The medical device for thermotherapy of the present invention is a medical device for thermotherapy which is used by being disposed on at least a part of a sole, and a heat generating part for generating heat transferred to the sole, and the heat generating part. And a container containing a moisture permeable sheet on at least one surface thereof, the heat generating portion contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day. It is characterized by being a chemical warmer. Hereinafter, the medical device for thermotherapy of the present invention will be described in detail.
［発熱部］
　本発明の温熱治療用の医療機器では、足底部に伝える熱を発生させるために、還元鉄粉を含む発熱部を有する。酸素との接触によって酸化熱を発生させる被酸化性金属として還元鉄粉を選択し、且つ後述する特定の透湿性を有する収容体を使用することによって、足底部の少なくとも一部に配設して使用すると、全身に温熱効果を付与することが可能になる。 [Heating part]
The medical device for hyperthermia treatment of the present invention has a heat generating portion containing reduced iron powder in order to generate heat transferred to the sole. By selecting reduced iron powder as an oxidizable metal that generates heat of oxidation by contact with oxygen, and by using a container having a specific moisture permeability described later, it is arranged on at least a part of the sole. When used, it becomes possible to give a thermal effect to the whole body.
　本発明において、「発熱部」とは、足底部に伝える熱を発生させる部位であり、被酸化性金属と必要に応じて配合される他の成分を含む発熱性組成物によって構成される。 In the present invention, the “heat-generating part” is a part that generates heat to be transmitted to the sole of the foot, and is composed of a heat-generating composition containing an oxidizable metal and other components that are optionally mixed.
　還元鉄粉とは、酸化鉄や鉄塩等の鉄化合物を水素等で還元して作製した粉末状の鉄である。 ≪Reduced iron powder is powdered iron produced by reducing iron compounds such as iron oxide and iron salts with hydrogen.
　本発明で使用される還元鉄粉の粒子径の範囲については、特に制限されないが、例えば、１０μｍ超８００μｍ以下が挙げられる。全身への温熱効果をより一層向上させるという観点から、還元鉄粉の粒子径として、好ましくは１０μｍ超５００μｍ以下、更に好ましくは１０μｍ超３００μｍ以下が挙げられる。本発明において、還元鉄粉の粒子径の範囲は、日本工業規格「ＪＩＳ　８８１５－１９９４　ふるい分け試験方法通則」に規定されている方法に従って求められる値である。 The range of the particle size of the reduced iron powder used in the present invention is not particularly limited, but examples thereof include more than 10 μm and 800 μm or less. From the viewpoint of further improving the heating effect on the whole body, the particle size of the reduced iron powder is preferably more than 10 μm and 500 μm or less, and more preferably more than 10 μm and 300 μm or less. In the present invention, the range of the particle size of the reduced iron powder is a value determined according to the method specified in the Japanese Industrial Standard “JIS 8815-1994 General Rules for Sifting Test Method”.
　本発明で使用される還元鉄粉の見掛密度については、特に制限されないが、例えば、１．０～４．０ｇ/ｃｍ2、好ましくは１．５～４．０ｇ/ｃｍ2、更に好ましくは２．０～４．０ｇ/ｃｍ2が挙げられる。本発明において、見掛密度は、日本工業規格「ＪＩＳ　Ｚ　２５０４：２０１２　金属粉－見掛密度測定方法」に規定されている方法に従って求められる値である。 The apparent density of the reduced iron powder used in the present invention is not particularly limited, but is, for example, 1.0 to 4.0 g/cm 2 , preferably 1.5 to 4.0 g/cm 2 , and more preferably 2.0 to 4.0 g/cm 2 can be mentioned. In the present invention, the apparent density is a value determined according to the method specified in Japanese Industrial Standard “JIS Z 2504:2012 Metal powder-Apparent density measuring method”.
　本発明において、発熱部における還元鉄粉の含有量としては、例えば、２０～８０重量％、好ましくは２５～７０重量％、更に好ましくは３０～６０重量％が挙げられる。 In the present invention, the content of the reduced iron powder in the heat generating part is, for example, 20 to 80% by weight, preferably 25 to 70% by weight, more preferably 30 to 60% by weight.
　また、本発明において、発熱部には、酸素の保持や、還元鉄粉への酸素供給の促進のために酸化促進剤が含まれていてもよい。酸化促進剤の種類については、酸素の保持及び還元鉄粉への酸素の供給が可能であることを限度として特に制限されないが、例えば、活性炭、カーボンブラック、アセチレンブラック、竹炭、木炭、コーヒーカス炭、黒鉛、石炭、椰子殻炭、暦青炭、泥炭、亜炭等の炭素材料が挙げられる。これらの酸化促進剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Further, in the present invention, the heat generating part may contain an oxidation promoter for holding oxygen and for promoting oxygen supply to the reduced iron powder. The type of the oxidation promoter is not particularly limited as long as it is capable of retaining oxygen and supplying oxygen to the reduced iron powder, but examples thereof include activated carbon, carbon black, acetylene black, bamboo charcoal, charcoal, coffee ground charcoal. , Carbon materials such as graphite, coal, coconut shell charcoal, calendar blue coal, peat and lignite. These oxidation promoters may be used alone or in combination of two or more.
　これらの酸化促進剤の中でも、好ましくは活性炭、カーボンブラック、竹炭、木炭、コーヒーカス炭、更に好ましくは活性炭が挙げられる。 Among these oxidation promoters, preferred are activated carbon, carbon black, bamboo charcoal, charcoal, coffee dust charcoal, and more preferably activated carbon.
　酸化促進剤の形状については、特に制限されないが、発熱効率の観点からは、好ましくは粉末状、粒状又は繊維状、更に好ましくは粉末状が挙げられる。 The shape of the oxidation promoter is not particularly limited, but from the viewpoint of heat generation efficiency, it is preferably powdery, granular or fibrous, and more preferably powdery.
　発熱部に酸化促進剤を含有させる場合、発熱部における酸化促進剤の含有量については、特に制限されないが、例えば、１～３０重量％、好ましく３～２５重量％、更に好ましくは５～２３重量％が挙げられる。 When the heat generating part contains an oxidation accelerator, the content of the oxidation promoter in the heat generating part is not particularly limited, but is, for example, 1 to 30% by weight, preferably 3 to 25% by weight, more preferably 5 to 23% by weight. %.
　また、発熱部には、還元鉄粉の酸化反応を促進させるために水が含まれていることが好ましい。水については、蒸留水、イオン交換水、純水、超純水、水道水、工業用水等のいずれを使用してもよい。 Also, it is preferable that the heat generating part contains water in order to accelerate the oxidation reaction of the reduced iron powder. As water, any of distilled water, ion-exchanged water, pure water, ultrapure water, tap water, industrial water, etc. may be used.
　発熱部に水を含有させる場合、発熱部における水の含有量については、特に制限されないが、例えば、５～５０重量％、好ましく１０～４０重量％、更に好ましくは１５～３５重量％が挙げられる。 When water is contained in the heat-generating part, the content of water in the heat-generating part is not particularly limited, but is, for example, 5 to 50% by weight, preferably 10 to 40% by weight, more preferably 15 to 35% by weight. ..
　また、発熱部には、水を保持させて酸化反応場に水を効率的に供給するために保水剤を含んでいてもよい。保水剤の種類については、特に制限されないが、例えば、バーミキュライト（蛭石）、パーライト、ケイ酸カルシウム、ケイ酸マグネシウム、カオリン、タルク、スメクタイト、マイカ、ベントナイト、炭酸カルシウム、シリカゲル、アルミナ、ゼオライト、二酸化珪素、珪藻土等の無機多孔質物質；パルプ、木粉（おがくず）、綿、デンプン類、セルロース類等の有機物；ポリアクリル酸系樹脂、ポリスルホン酸系樹脂、無水マレイン酸系樹脂、ポリアクリルアミド系樹脂、ポリビニルアルコール系樹脂、ポリエチレンオキシド系樹脂、ポリアスパラギン酸系樹脂、ポリグルタミン酸系樹脂、ポリアルギン酸系樹脂等の吸水性樹脂等が挙げられる。これらの保水剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Also, the heat generating part may contain a water retention agent in order to retain water and efficiently supply water to the oxidation reaction field. The type of the water retention agent is not particularly limited, but for example, vermiculite (calculus), perlite, calcium silicate, magnesium silicate, kaolin, talc, smectite, mica, bentonite, calcium carbonate, silica gel, alumina, zeolite, dioxide. Inorganic porous materials such as silicon and diatomaceous earth; organic substances such as pulp, wood powder (sawdust), cotton, starches, celluloses; polyacrylic acid resins, polysulfonic acid resins, maleic anhydride resins, polyacrylamide resins Examples thereof include water absorbent resins such as polyvinyl alcohol resins, polyethylene oxide resins, polyaspartic acid resins, polyglutamic acid resins, and polyalginic acid resins. These water retention agents may be used alone or in combination of two or more.
　これらの保水剤の中でも、好ましくはバーミキュライト、ポリアクリル酸系樹脂、木粉、パルプ；更に好ましくはバーミキュライト、ポリアクリル酸系樹脂が挙げられる。また、保水剤として無機多孔質物質を使用する場合には、発熱性組成物中で空気の流路を確保することも可能になる。 Among these water retention agents, preferably vermiculite, polyacrylic acid-based resin, wood powder, pulp; more preferably vermiculite, polyacrylic acid-based resin. Further, when an inorganic porous material is used as the water retention agent, it becomes possible to secure an air flow path in the exothermic composition.
　発熱部に保水剤を含有させる場合、発熱部における保水剤の含有量については、その含有量については、特に制限されないが、例えば、１～２０重量％、好ましくは３～１５重量％、更に好ましくは３～７重量％が挙げられる。 When a water retention agent is contained in the heat generating part, the content of the water retention agent in the heat generating part is not particularly limited, but is, for example, 1 to 20% by weight, preferably 3 to 15% by weight, and further preferably Is 3 to 7% by weight.
　また、発熱部には、還元鉄粉の酸化反応を促進させるために水溶性塩類を含んでいてもよい。水溶性塩類の種類については、特に制限されないが、例えば、アルカリ金属（ナトリウム、カリウム等）、アルカリ土類金属（カルシウム、マグネシウム等）、又は重金属（鉄、銅、アルミニウム、亜鉛、ニッケル、銀、バリウム等）の硫酸塩、炭酸水素塩、塩化物若しくは水酸化物等が挙げられる。これらの水溶性塩類の中でも、導電性、化学的安定性等の観点から、好ましくは塩化ナトリウム、塩化カリウム、塩化カルシウム、塩化マグネシウム、塩化鉄（第１、第２）等の塩化物、更に好ましくは塩化ナトリウムなどが挙げられる。これらの水溶性塩類は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 Also, the exothermic part may contain water-soluble salts in order to accelerate the oxidation reaction of the reduced iron powder. The type of water-soluble salt is not particularly limited, but examples thereof include alkali metals (sodium, potassium, etc.), alkaline earth metals (calcium, magnesium, etc.), or heavy metals (iron, copper, aluminum, zinc, nickel, silver, Sulfates, hydrogen carbonates, chlorides or hydroxides of barium). Among these water-soluble salts, chlorides such as sodium chloride, potassium chloride, calcium chloride, magnesium chloride, iron chloride (first and second) are more preferable, from the viewpoints of conductivity, chemical stability, and the like, and further preferable. Examples include sodium chloride. These water-soluble salts may be used alone or in combination of two or more.
　発熱部に水溶性塩類を含有させる場合、発熱部における水溶性塩類の含有量については、その含有量については、特に制限されないが、例えば、０．１～１０重量％、好ましくは０．５～７重量％、更に好ましくは０．５～５重量％が挙げられる。 When the heat-generating part contains a water-soluble salt, the content of the water-soluble salt in the heat-generating part is not particularly limited, but is, for example, 0.1 to 10% by weight, preferably 0.5 to 7% by weight, and more preferably 0.5 to 5% by weight.
　発熱部には、更に必要に応じて、還元鉄粉以外の被酸化金属、金属イオン封鎖剤、香料、増粘剤、賦形剤、界面活性剤、水素発生抑制剤等が他の添加剤が含まれていてもよい。 In the heat generating part, if necessary, other additives such as a metal to be oxidized other than the reduced iron powder, a sequestering agent, a fragrance, a thickener, an excipient, a surfactant, a hydrogen generation inhibitor, etc. may be added. May be included.
　発熱部として使用される発熱性組成物は、前述する成分を所定量混合することにより調製することができる。発熱部として使用される発熱性組成物の調製は、酸素存在下で行ってもよいが、減圧下又は不活性ガス雰囲気下で調製することが好ましい。 The exothermic composition used as the exothermic part can be prepared by mixing the above-mentioned components in predetermined amounts. The exothermic composition used as the exothermic part may be prepared in the presence of oxygen, but is preferably prepared under reduced pressure or in an inert gas atmosphere.
　本発明の温熱治療用の医療機器において、収容体１個当たりに収容される発熱部の量については、足底部に適用可能な範囲内で適宜設定すればよいが、例えば、５～３０ｇ、好ましくは１０～２０ｇ、更に好ましくは１２～１８ｇが挙げられる。 In the medical device for hyperthermia of the present invention, the amount of the heat-generating part accommodated in each container may be appropriately set within the range applicable to the sole, but is preferably 5 to 30 g, preferably Is 10 to 20 g, more preferably 12 to 18 g.
［収容体］
　本発明の温熱治療用の医療機器は、発熱部を収容するための収容体を有する。本発明の温熱治療用の医療機器において、収容体は、使用時に発熱部に酸素や水蒸気を供給するために、少なくとも一方の面に透湿度が３００～１２００ｇ／ｍ2・ｄａｙである透湿性シートを有している。このように特定の透湿度の透湿性シートを有する収容体と、還元鉄粉を含む発熱部とを併用することによって、足底部に適用しても、全身に対して温熱効果を付与することが可能になる。 [Container]
The medical device for hyperthermia treatment of the present invention has a container for housing the heat generating portion. In the medical device for thermotherapy of the present invention, the container is a moisture permeable sheet having a moisture permeability of 300 to 1200 g/m 2 ·day on at least one surface in order to supply oxygen and water vapor to the heat generating portion during use. have. Thus, by using the container having the moisture-permeable sheet having a specific moisture permeability and the heat-generating part containing the reduced iron powder together, it is possible to give a thermal effect to the whole body even when applied to the sole. It will be possible.
　本発明で使用される透湿性シートの透湿度については、３００～１２００ｇ／ｍ2・ｄａｙであればよいが、全身への温熱効果をより一層向上させるという観点から、当該透湿性シートの透湿度として、好ましくは６５０～１２００ｇ／ｍ2・ｄａｙ、更に好ましくは６８０～１１５０ｇ／ｍ2・ｄａｙ、特に好ましくは７００～１１００ｇ／ｍ2・ｄａｙが挙げられる。本発明において、透湿度は、日本工業規格「ＪＩＳ　Ｚ０２０８－１９７５　防湿包装材料の透湿度試験方法（カップ法）に規定されている方法で温度４０℃、湿度９０％ＲＨの条件下で測定される値である。 The moisture permeability of the moisture-permeable sheet used in the present invention may be 300 to 1200 g/m 2 ·day. It is preferably 650 to 1200 g/m 2 ·day, more preferably 680 to 1150 g/m 2 ·day, and particularly preferably 700 to 1100 g/m 2 ·day. In the present invention, the water vapor transmission rate is measured under the conditions of a temperature of 40° C. and a humidity of 90% RH by the method specified in Japanese Industrial Standard “JIS Z0208-1975 Moisture vapor transmission test method (cup method) for moisture-proof packaging materials. It is a value.
　透湿性シートの素材については、前記透湿度を具備できることを限度として特に制限されないが、少なくとも、通気性樹脂層（細孔を有する樹脂層）によって形成されていることが好ましく、使用感を向上させるという観点から、通気性樹脂層と繊維基材との積層シートであることが更に好ましい。通気性樹脂層と繊維基材との積層シートは、収容体の内部から外部に向けて、通気性樹脂層及び繊維基材がこの順で積層されていればよい。 The material of the moisture-permeable sheet is not particularly limited as long as it has the moisture permeability, but it is preferable that it is formed of at least a breathable resin layer (resin layer having pores) to improve the usability. From this point of view, a laminated sheet of a breathable resin layer and a fiber base material is more preferable. In the laminated sheet of the air-permeable resin layer and the fiber base material, the air-permeable resin layer and the fiber base material may be laminated in this order from the inside to the outside of the container.
　通気性樹脂層の構成樹脂については、特に制限されないが、例えば、ポリエチレン、ポリプロピレン、エチレン－酢酸ビニル共重合体、ポリエチレンテレフタレート、ポリアクリロニトリル、エチレン－ビニルアルコール共重合体、ポリアミド、ポリウレタン、ポリスチレン、ポリビニルアルコール、ポリ塩化ビニル、ポリ塩化ビニリデン、ポリカーボネート等が挙げられる。これらの樹脂の中でも、好ましくはポリエチレン、ポリプロピレン、エチレン酢酸ビニル共重合体が挙げられる。 The constituent resin of the gas permeable resin layer is not particularly limited, and examples thereof include polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polyacrylonitrile, ethylene-vinyl alcohol copolymer, polyamide, polyurethane, polystyrene, polyvinyl. Examples thereof include alcohol, polyvinyl chloride, polyvinylidene chloride, and polycarbonate. Among these resins, polyethylene, polypropylene and ethylene vinyl acetate copolymer are preferable.
　また、通気性樹脂層は、通気性を確保するための細孔が設けられている樹脂フィルムであればよい。樹脂フィルムに設けられる細孔の形状、大きさ及び数については、収容体に備えさせるべき透湿度に応じて適宜設定すればよい。 Also, the breathable resin layer may be a resin film provided with pores for ensuring breathability. The shape, size and number of the pores provided in the resin film may be appropriately set according to the moisture permeability to be provided in the container.
　通気性樹脂層の厚さについては、透湿性シートの層構成等に応じて適宜設定すればよいが、例えば、１５～１５０μｍ、好ましくは３０～１００μｍ、更に好ましくは５０～８０μｍが挙げられる。 The thickness of the breathable resin layer may be appropriately set according to the layer structure of the moisture permeable sheet, and is, for example, 15 to 150 μm, preferably 30 to 100 μm, and more preferably 50 to 80 μm.
　透湿性シートに使用される繊維基材としては、具体的には、不織布、織布が挙げられる。使用感等の観点から、好ましくは不織布が挙げられる。繊維基材２３２の素材については、特に制限されないが、例えば、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ナイロン、ポリプロピレン、ポリエチレン、ビニロン、レーヨン、アクリル、アセテート、ポリ塩化ビニル等の合成繊維；綿、麻、絹、紙等の天然繊維；これらの混合繊維等が挙げられる。これらの素材の中でも、使用感を高めるという観点から、好ましくはポリエチレンテレフタレート、ナイロン、ポリプロピレン、更に好ましくはポリエチレンテレフタレート、ナイロンが挙げられる。 Specific examples of the fiber base material used for the moisture permeable sheet include non-woven fabric and woven fabric. From the viewpoint of usability, a non-woven fabric is preferable. The material of the fiber base material 232 is not particularly limited, but for example, synthetic fibers such as polyethylene terephthalate, polybutylene terephthalate, nylon, polypropylene, polyethylene, vinylon, rayon, acrylic, acetate, polyvinyl chloride; cotton, hemp, silk. , Natural fibers such as paper; and mixed fibers thereof. Among these materials, polyethylene terephthalate, nylon and polypropylene are preferable, and polyethylene terephthalate and nylon are more preferable, from the viewpoint of enhancing the feeling of use.
　繊維基材の目付けについては、透湿性シートの層構成等に応じて適宜設定すればよいが、例えば、１～１００ｇ／ｍ2、好ましくは５～７０ｇ／ｍ2、更に好ましくは１０～５０ｇ／ｍ2が挙げられる。 The basis weight of the fibrous base material may be appropriately set according to the layer structure of the moisture-permeable sheet and the like, but is, for example, 1 to 100 g/m 2 , preferably 5 to 70 g/m 2 , and more preferably 10 to 50 g/m 2 . m 2 may be mentioned.
　通気性樹脂層と繊維基材の積層は、ドライラミネート、押出ラミネート、熱ラミネート等の公知のラミネート方法によって行うことができる。 The air-permeable resin layer and the fiber base material can be laminated by a known laminating method such as dry laminating, extrusion laminating or heat laminating.
　本発明で使用される収容体は、少なくとも一方の面に前記透湿性シートを含んでいればよい。本発明で使用される収容体は、足底部側に配される面と、それとは反対側に配される面の２つ面を有する形状であることが好ましいが、このように２つ面を有する形状にする場合、全面が前記透湿性シートで形成されていてもよく、また一方の面が前記透湿性シートで、他方の面が低透湿度のシート（以下、「非透湿性シート」と表記することがある）によって形成されていてもよい。 The container used in the present invention may include the moisture-permeable sheet on at least one surface. The container used in the present invention preferably has a shape having two surfaces, a surface arranged on the sole side and a surface arranged on the opposite side. In the case of having the shape, the entire surface may be formed of the moisture permeable sheet, and one surface is the moisture permeable sheet, and the other surface is a low moisture permeable sheet (hereinafter referred to as “non-moisture permeable sheet”). May be described).
　前記非透湿性シートの透湿度については、例えば１０ｇ／ｍ2・ｄａｙ以下、好ましくは５ｇ／ｍ2・ｄａｙ以下、より好ましくは２ｇ／ｍ2・ｄａｙ以下、更に好ましくは１ｇ／ｍ2・ｄａｙ以下、特に好ましくは０ｇ／ｍ2・ｄａｙが挙げられる。 Wherein the moisture permeability of the moisture-impermeable sheet, for example 10g / m 2 · day or less, preferably 5g / m 2 · day or less, more preferably 2g / m 2 · day or less, more preferably 1g / m 2 · day Below, 0 g/m 2 ·day is particularly preferable.
　非透湿性シートの素材については、特に制限されないが、好ましくは、細孔が設けられていない樹脂シートが挙げられる。非透湿性シートを構成する樹脂シートの構成樹脂については、特に制限されないが、例えば、ポリエチレン、ポリプロピレン、エチレン－酢酸ビニル共重合体、ポリエチレンテレフタレート、ポリアクリロニトリル、エチレン－ビニルアルコール共重合体、ポリアミド、ポリウレタン、ポリスチレン、ポリビニルアルコール、ポリ塩化ビニル、ポリ塩化ビニリデン、ポリカーボネート等が挙げられる。これらの樹脂の中でも、好ましくはポリエチレン、ポリプロピレン、エチレン酢酸ビニル共重合体が挙げられる。 The material of the non-moisture permeable sheet is not particularly limited, but a resin sheet having no pores is preferable. The constituent resin of the resin sheet constituting the non-moisture permeable sheet is not particularly limited, and examples thereof include polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polyacrylonitrile, ethylene-vinyl alcohol copolymer, polyamide, Examples thereof include polyurethane, polystyrene, polyvinyl alcohol, polyvinyl chloride, polyvinylidene chloride, and polycarbonate. Among these resins, polyethylene, polypropylene and ethylene vinyl acetate copolymer are preferable.
　非透湿性シートを構成する樹脂シートの厚さについては、非透湿性シートの層構成等に応じて適宜設定すればよいが、例えば、１１５～２５０μｍ、好ましくは１３０～２００μｍ、更に好ましくは１５０～１８０μｍが挙げられる。 The thickness of the resin sheet forming the non-moisture permeable sheet may be appropriately set according to the layer structure of the non-moisture permeable sheet, and is, for example, 115 to 250 μm, preferably 130 to 200 μm, more preferably 150 to 180 μm can be mentioned.
　また、非透湿性シートは、必要に応じて、細孔が設けられていない樹脂シートに繊維基材が積層されていてもよい。非透湿性シートにおいて使用される繊維基材の素材や目付等については、前記透湿質性シートで例示したものと同様である。 The non-moisture permeable sheet may have a fiber base material laminated on a resin sheet having no pores, if necessary. The material and basis weight of the fiber base material used in the non-moisture permeable sheet are the same as those exemplified for the moisture permeable sheet.
　また、収容体の一方の面には、使用時に足底部に固定できるように粘着層が設けられていることが好ましい。収容体において、両面とも前記透湿性シートで形成されている場合には、一方の透湿性シートの表面に粘着層が設けられていればよく、また一方の面が透湿性シート、他方の面が非透湿性シートで形成されている場合には、非透湿性シートの表面に粘着層が設けられていればよい。 Also, one surface of the container is preferably provided with an adhesive layer so that it can be fixed to the sole of the foot when used. In the container, in the case where both surfaces are formed of the moisture permeable sheet, it suffices if an adhesive layer is provided on the surface of one moisture permeable sheet, and one surface is a moisture permeable sheet, and the other surface is When formed of a non-moisture permeable sheet, an adhesive layer may be provided on the surface of the non-moisture permeable sheet.
　粘着層は、収容体の一方の面の全面に設けられていてもよいが、収容体の一方の面に部分的に設けられていてもよい。 The adhesive layer may be provided on the entire one surface of the container, or may be partially provided on one surface of the container.
　粘着層は、粘着剤を使用して形成できる。粘着剤とは、油剤やその他の溶媒等の存在下で粘着性を示すポリマー（粘着性ポリマー）を含み、当該粘着性ポリマーが油剤やその他の溶媒等に分散又は溶解されて、粘着性を呈している組成物である。粘着剤に含まれる粘着性ポリマーの種類や組成は、公知であり、本発明では、従来の使い捨てカイロの粘着層に使用されている粘着剤を使用することができる。粘着剤の種類としては、具体的には、ゴム系粘着剤、アクリル系粘着剤、シリコーン系粘着剤、ウレタン系粘着剤等が挙げられる。 The adhesive layer can be formed using an adhesive. The adhesive includes a polymer (adhesive polymer) that exhibits adhesiveness in the presence of an oil agent or other solvent, and the adhesive polymer is dispersed or dissolved in the oil agent or other solvent to exhibit adhesiveness. The composition. The type and composition of the adhesive polymer contained in the adhesive are known, and in the present invention, the adhesive used in the adhesive layer of the conventional disposable body warmer can be used. Specific examples of the type of adhesive include rubber-based adhesives, acrylic-based adhesives, silicone-based adhesives, urethane-based adhesives, and the like.
　粘着層の塗布量については、例えば、５～４０ｇ／ｍ2、好ましくは１０～３０ｇ／ｍ2、更に好ましくは１５～２５ｇ／ｍ2が挙げられる。 The coating amount of the adhesive layer is, for example, 5 to 40 g/m 2 , preferably 10 to 30 g/m 2 , and more preferably 15 to 25 g/m 2 .
　また、収容体の一方の面に粘着層を設ける場合には、粘着層の外側表面には、離型可能な離型層が設けられていてもよい。離型層が設けられている場合には、保存中の粘着層の乾燥防止、粘着層の粘着による取扱性の低下の防止等を図ることができる。 Further, when the adhesive layer is provided on one surface of the container, a release layer capable of releasing may be provided on the outer surface of the adhesive layer. When the release layer is provided, it is possible to prevent the adhesive layer from being dried during storage and prevent the handling property from being deteriorated due to the adhesion of the adhesive layer.
　離型層としては、ポリエチレンテレフタラート、ポリアクリロ二トリル、エチレン－ビニルアルコール共重合体、ポリプロピレン等の樹脂フィルム；シリコーン加工等の離型性付与加工を施した紙等が挙げられる。また、離型層として樹脂フィルムを使用する場合であっても、シリコーン加工等の離型性付与加工が施されていてもよい。 Examples of the release layer include resin films such as polyethylene terephthalate, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and polypropylene; paper that has been subjected to a release property imparting treatment such as silicone processing. Further, even when the resin film is used as the release layer, the release property imparting process such as silicone process may be applied.
　収容体は、足底部側に配される面と、それとは反対側に配される面の２つ面からなる形状である場合、前記透湿性シート２枚、又は前記透湿性シート１枚と前記非透湿性シート１枚を、発熱部を収容する領域の周囲を張り合わせることによって形成される。 When the container has a shape composed of two surfaces, a surface arranged on the sole side and a surface arranged on the opposite side, the two moisture-permeable sheets or the one moisture-permeable sheet and the one sheet It is formed by sticking one non-moisture permeable sheet around the area for accommodating the heat generating portion.
　前記透湿性シート２枚、又は前記透湿性シート１枚と前記非透湿性シート１枚を張り合わせる手法については、特に制限されないが、例えば、前記透湿性シート又は非透湿性シートに熱溶着性樹脂が使用されている場合は当該熱融着性樹脂を利用して端部を熱溶着（ヒートシール）させてもよく、また接着剤を使用して端部を張り合わせてもよい。 The method for laminating the two moisture-permeable sheets or the one moisture-permeable sheet and the one non-moisture permeable sheet is not particularly limited, but, for example, the moisture-permeable resin or the non-moisture permeable sheet may be attached to the heat-welding resin. When is used, the ends may be heat-welded (heat-sealed) by using the heat-fusible resin, or the ends may be bonded by using an adhesive.
　収容体の形状については、足底部の少なくとも一部に配設できるように設定されていればよく、適用する足底部の部位に応じて適宜設定すればよい。例えば、足の指の裏の一部から指の裏の付け根部分にわたって配設する場合であれば、図１に示すように、平面視形状が、直線状の端辺から一方の方向に伸びて他方の端辺が円形になっている形状が挙げられる。また、収容体の一形態として略扁平状が挙げられるが、収容体において足底部側に配される面は、足底部の形状に追従するように凹部や凸部等が設けられていてもよい。 The shape of the container may be set so that it can be disposed on at least a part of the bottom of the foot, and may be appropriately set according to the part of the foot to be applied. For example, in the case of arranging from a part of the back of the toes to the base of the back of the toes, as shown in FIG. 1, the shape in plan view extends from the linear end side in one direction. A shape in which the other end side is circular is mentioned. Moreover, although a substantially flat shape is mentioned as one form of the container, the surface of the container disposed on the side of the sole may be provided with a concave portion or a convex portion so as to follow the shape of the sole. ..
　収容体において前記発熱部を収容する部分の面積（平面視した場合に、発熱部が収容されている部分の面積）としては、例えば、２０～１８０ｃｍ2、好ましくは３０～７０ｃｍ2、更に好ましくは３５～６０ｃｍ2が挙げられる。 The area of the portion that accommodates the heat generating portion in the container (the area of the portion that accommodates the heat generating portion in plan view) is, for example, 20 to 180 cm 2 , preferably 30 to 70 cm 2 , and more preferably 35-60 cm 2 can be mentioned.
［包装形態］
　本発明の温熱治療用の医療機器は、酸素バリア性を有する包装材に包装され、空気と接触しない状態で提供される。使用時に足底部の少なくとも一部に配設することにより、発熱部が空気と接触し、発熱が開始する。 [Package presentation]
The medical device for hyperthermia treatment of the present invention is packaged in a packaging material having an oxygen barrier property and provided without contact with air. By disposing it on at least a part of the sole during use, the heat generating part comes into contact with the air and heat generation starts.
［使用方法］
　本発明の温熱治療用の医療機器は、足底部の少なくとも一部に配設して使用される。本発明の温熱治療用の医療機器は、足底部の少なくとも一部に対して局所的に適用することにより、手、足、肩等の全身に対して温熱効果を付与することができる。また、本発明の温熱治療用の医療機器は、全身に対して温熱効果を付与できるので、全身の血行促進、冷え性の改善、疲労感の改善、筋肉のコリの改善、胃腸の働きの活発化、免疫賦活化等の目的で使用できる。 [how to use]
The medical device for hyperthermia treatment of the present invention is used by being disposed on at least a part of the sole. The medical device for hyperthermia of the present invention can be locally applied to at least a part of the sole of the foot to impart a heating effect to the whole body such as hands, feet, and shoulders. Further, since the medical device for hyperthermia of the present invention can impart a thermal effect to the whole body, it promotes blood circulation in the whole body, improves coldness, improves tiredness, improves muscle stiffness, and activates gastrointestinal function. It can be used for the purpose of immunostimulation.
　本発明の温熱治療用の医療機器は、足底部に皮膚に直接固定して使用してもよく、また靴下をはいた状態で足底部に固定して使用してもよく。また、本発明の温熱治療用の医療機器は、靴やスリッパの中敷きに固定し、当該靴やスリッパを履くことによって使用することもできる。 The medical device for hyperthermia treatment of the present invention may be used by directly fixing it to the skin on the sole of the foot, or by fixing it to the sole of the foot while wearing socks. Further, the medical device for thermotherapy of the present invention can be used by fixing it to the insole of shoes or slippers and putting on the shoes or slippers.
　本発明の温熱治療用の医療機器が適用される足底部の部位については、特に制限されず、例えば、足指の裏、足指の裏の付け根、土踏まず、短小趾屈筋部分、踵等が挙げられる。また、本発明の温熱治療用の医療機器は、足底部の少なくとも一部に配設されるように設計されていればよく、例えば、足底部の一部と共に、足の指の表部分や足の甲の少なくとも一部にも配設されるように設計されていてもよい。全身への温熱効果をより一層向上させるという観点から、本発明の温熱治療用の医療機器が配設される足底部の部位として、好ましくは、少なくとも足指の裏の付け根部分、更に好ましくは足指の裏の少なくとも一部と足指の裏の付け根部分、特に好ましくは、足の中指の先端から０～１ｃｍ程度の部位から踵側に向かって９～２０ｃｍ程度までの領域の足底部が挙げられる。 The site of the plantar part to which the medical device for hyperthermia treatment of the present invention is applied is not particularly limited, and examples thereof include the back of the toes, the base of the back of the toes, the arch, the small flexor flexor portion, and the heel. To be Further, the medical device for hyperthermia treatment of the present invention may be designed so as to be arranged on at least a part of the sole of the foot, and for example, together with a part of the bottom of the foot, a front part of a toe or a foot It may be designed so as to be arranged also on at least a part of the instep. From the viewpoint of further improving the heating effect on the whole body, as the part of the sole of the foot where the medical device for thermotherapy of the present invention is arranged, preferably at least the base part of the back of the toes, more preferably the foot. At least a part of the back of the toes and the base of the back of the toes, and particularly preferably, the sole of the region from about 0 to 1 cm from the tip of the middle toe to about 9 to 20 cm toward the heel side. To be
　以下に、実施例等を挙げて、本発明を具体的に説明するが、本発明はこれらによって何ら限定されるものではない。 Hereinafter, the present invention will be specifically described with reference to Examples and the like, but the present invention is not limited thereto.
１．温熱治療用の医療機器の調製
　表１に示す各透湿度の透湿性シートＡ～Ｆを準備した。各透湿性シートの形状は、図２のＡに示す通りである。なお、各透湿性シートの透湿度は、日本工業規格「ＪＩＳ　Ｚ０２０８－１９７５　防湿包装材料の透湿度試験方法（カップ法）に規定されている方法で温度４０℃、湿度９０％ＲＨの条件下で測定した。なお、準備した透湿性シートＡ～Ｆは、いずれも、ポリエチレンテレフタレート製のスパンレース不織布（目付３０ｇ／ｍ2）と細孔が設けられたポリエチレンフィルム（厚み６０μｍ）がドライラミネートによって接着されている積層シートであり、透湿度は、ポリエチレンフィルムの細孔の大きさと数で制御されている。
Figure JPOXMLDOC01-appb-T000001
 1. Preparation of Medical Devices for Hyperthermia The moisture-permeable sheets A to F having various moisture permeability shown in Table 1 were prepared . The shape of each moisture permeable sheet is as shown in FIG. The moisture permeability of each moisture permeable sheet is measured under the conditions of temperature 40° C. and humidity 90% RH by the method specified in Japanese Industrial Standard “JIS Z0208-1975 moisture proof packaging material moisture permeability test method (cup method)”. In each of the prepared moisture-permeable sheets A to F, a spunlace nonwoven fabric made of polyethylene terephthalate (weight per unit area: 30 g/m 2 ) and a polyethylene film (thickness 60 μm) provided with pores were bonded by dry lamination. The moisture permeability is controlled by the size and number of pores of the polyethylene film.
Figure JPOXMLDOC01-appb-T000001
　また、透湿度が０ｇ／ｍ2・ｄａｙである非透湿性シート（厚み１５９μｍ）を準備した。非透湿性シートの形状は、図２のＡに示す通りである。当該非透湿性シートの一方面に、粘着剤を２１ｇ／ｍ2となるように塗布した後に、離型シートを積層させた。 Further, a non-moisture permeable sheet (thickness 159 μm) having a moisture permeability of 0 g/m 2 ·day was prepared. The shape of the moisture impermeable sheet is as shown in A of FIG. A pressure-sensitive adhesive was applied to one surface of the non-moisture permeable sheet at a rate of 21 g/m 2, and then a release sheet was laminated.
　また、別途、表２に示す各種鉄粉を準備した。なお、鉄粉Ａは、鉄粉（「ＭＲ２」、（同和鉄粉工業株式会社製）を目開き１８０μｍのメッシュによって分級し、当該メッシュに残った鉄粉を回収することにより調製した。鉄粉Ｂは、鉄粉（「ＭＲ２」、（同和鉄粉工業株式会社製）を目開き４５μｍのメッシュによって分級し、当該メッシュを通過した鉄粉を回収することにより調製した。鉄粉Ｃは、鉄粉（「８０ＡＦ」、（株式会社神戸製鋼所製）を使用した。鉄粉Ｄは、鉄粉（「８０ＡＦ」、（株式会社神戸製鋼所製）を目開き１８０μｍのメッシュによって分級し、当該メッシュに残った鉄粉を回収することにより調製した。なお、見掛密度は、日本工業規格「ＪＩＳ　Ｚ　２５０４：２０１２　金属粉－見掛密度測定方法」に規定されている方法によって測定した。
Figure JPOXMLDOC01-appb-T000002
 In addition, various iron powders shown in Table 2 were prepared separately. The iron powder A was prepared by classifying iron powder (“MR2” (manufactured by Dowa Iron Powder Industry Co., Ltd.) with a mesh having an opening of 180 μm, and collecting the iron powder remaining on the mesh. B was prepared by classifying iron powder (“MR2”, (manufactured by Dowa Iron Powder Industry Co., Ltd.) with a mesh having an opening of 45 μm, and collecting the iron powder that passed through the mesh. Powder (“80AF”, (manufactured by Kobe Steel, Ltd.) was used. As for iron powder D, the iron powder (“80AF”, (manufactured by Kobe Steel, Ltd.) was classified by a mesh having an opening of 180 μm, and the mesh was used. It was prepared by recovering the iron powder remaining in No. 1. The apparent density was measured by the method specified in Japanese Industrial Standards "JIS Z 2504:2012 Metal powder-Apparent density measuring method".
Figure JPOXMLDOC01-appb-T000002
　前記各鉄粉を使用して、表３に示す組成の発熱性組成物を調製し、発熱体として使用した。透湿性シートの不織布側と非透湿性シートに積層させた粘着層が、それぞれ外側になるように配して、調製した発熱体１３ｇを、前記透湿性シートと前記非透湿性シートで挟持させた。その状態で、平面視で図２のＢのようになるように両シートの周縁部（幅０．５ｃｍ）を熱溶着し、収容部に発熱体が収容されてなる温熱治療用の医療機器を製造した（図２のＢにおいて周囲を囲む黒線部が熱融着させた周縁部である）。なお、製造した温熱治療用の医療機器の収容体において、発熱部を収容する部分の面積（平面視した場合に、発熱部が収容されている部分の面積）は５７ｃｍ2である。 An exothermic composition having the composition shown in Table 3 was prepared using each of the iron powders and used as a heating element. The non-woven fabric side of the moisture permeable sheet and the pressure-sensitive adhesive layer laminated on the non-moisture permeable sheet were arranged such that they were on the outside, and the prepared heating element 13g was sandwiched between the moisture permeable sheet and the non-moisture permeable sheet. .. In that state, the peripheral edge portion (width 0.5 cm) of both sheets is heat-welded so as to be as shown in FIG. 2B in a plan view, and a medical device for thermotherapy having a heating element housed in the housing portion. It was manufactured (the black line portion surrounding the periphery in B of FIG. 2 is the peripheral portion which is heat-sealed). In the manufactured container for the medical device for thermotherapy, the area of the part that accommodates the heat generating portion (the area of the part that accommodates the heat generating portion in plan view) is 57 cm 2 .
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
　製造した温熱治療用の医療機器は、素早く、ガス非透過性の密封袋に収容して密封した。なお、製造した温熱治療用の医療機器において、透湿性シートと発熱体で使用した鉄粉の組み合わせは、表４に示す通りである。 The medical device for hyperthermia treatment that was manufactured was quickly housed and sealed in a gas-impermeable sealed bag. The combinations of the moisture-permeable sheet and the iron powder used in the heating element in the manufactured medical device for thermotherapy are as shown in Table 4.
２．全身に対する温熱効果の評価
（１）貼り付け用サンプルの調製
　市販の新品の靴下（構成素材：ポリエステル５３重量％、ナイロン４２重量％、及びポリウレタン５重量％）の足底部位を切り取って、長方形（縦１０ｃｍ、横８ｃｍ）の下布を得た。当該下地の一方の面に、前記で得られた温熱治療用の医療機器の粘着層側を張り合わせた。更に、当該下地の他方の面の両端に２本の両面テープを張り合わせて、貼り付け用サンプルを得た。図３のＡに、貼り付け用サンプルを温熱治療用の医療機器側から平面視した図を示し、図３のＢに、貼り付け用サンプルを両面テープ側から平面視した図を示す。 2. Evaluation of thermal effect on the whole body (1) Preparation of sample for attachment Commercially available new socks (constituting material: 53% by weight of polyester, 42% by weight of nylon, and 5% by weight of polyurethane) are cut out to form a rectangle ( A bottom cloth having a length of 10 cm and a width of 8 cm was obtained. The adhesive layer side of the medical device for hyperthermia obtained above was adhered to one surface of the base. Further, two double-sided tapes were attached to both ends of the other surface of the base to obtain a sample for sticking. FIG. 3A shows a plan view of the sticking sample as seen from the side of the medical device for thermotherapy, and FIG. 3B shows a plan view of the sticking sample as seen from the double-sided tape side.
（２）温熱効果の測定
　２９歳の男性１名を被験者として、以下の方法で血流量の測定を行った。先ず、測定室内を温度２０℃、湿度３０％ＲＨに設定し、温度及び湿度が安定するのを確認するため、約１時間部屋を放置した。次いで、靴下と海水パンツのみを着用している被験者を測定室に入室させ、靴下を脱いだ状態にして３０分間の馴化後、足（右足のくるぶし部分）、手（右手の甲部分）、及び肩（右肩の背面部分）の血流（貼付前の血流）をドップラー血流計(株式会社インテグラル製「ＰｅｒｉＳｃａｎ」)で測定した（貼付前の血流量）。次いで、図３のＡに示す頂点Ｘの部分が、左足裏の中指の先端から１ｃｍ踵よりの部分になるようにして、頂点Ｘが指側、端辺Ｙが踵側になるように、両面テープを介して、貼り付け用サンプルを足裏の指裏から付け根の領域に貼り合わせて、６０分間その状態を維持した。 (2) Measurement of thermal effect One 29-year-old man was used as a subject, and blood flow was measured by the following method. First, the temperature inside the measurement room was set to 20° C. and the humidity was set to 30% RH, and the room was left for about 1 hour in order to confirm that the temperature and humidity were stable. Next, a subject wearing only socks and seawater pants is allowed to enter the measurement room, the socks are taken off, and after acclimatizing for 30 minutes, the foot (the ankle part of the right foot), the hand (the back part of the right hand), and the shoulder The blood flow (the blood flow before attachment) of the (back part of the right shoulder) was measured with a Doppler blood flow meter (“PeriScan” manufactured by Integral Co., Ltd.) (blood flow before attachment). Then, the portion of the apex X shown in FIG. 3A is located 1 cm from the tip of the middle finger of the left sole from the heel, and the apex X is on the finger side and the end side Y is on the heel side. The sample for sticking was stuck to the region of the base from the back of the toes through the tape, and the state was maintained for 60 minutes.
　貼り付け用サンプルを足底部に貼り合わせてから６０分間経過した後に、足（右足のくるぶし部分）、手（右手の甲部分）、及び肩（右肩の背面部分）の血流（貼付後の血流）をドップラー血流計で測定した。貼付後の血流の値から貼付前の血流の値を差し引くことにより、使用後の血流の変化量を算出した。 After 60 minutes have passed since the sample for attachment was attached to the sole of the foot, blood flow (blood after attachment) of the foot (the ankle part of the right foot), the hand (the back part of the right shoulder), and the shoulder (the back part of the right shoulder). Flow) was measured with a Doppler blood flow meter. The amount of change in blood flow after use was calculated by subtracting the value of blood flow before application from the value of blood flow after application.
　また、同じ被験者で、貼り付け用サンプルの貼付部位を左足裏の踵に変更して、同様の方法で血流の測定を行った。なお、貼り付け用サンプルを左足裏の踵に貼り合わせる場合には、図３のＡに示す頂点Ｘが踵の頂点側、端辺Ｙが足指側に配されるにした。 Also, in the same subject, the attachment site of the attachment sample was changed to the heel of the left sole, and blood flow was measured by the same method. When the sticking sample is stuck to the heel of the left sole, the apex X shown in FIG. 3A is arranged on the apex side of the heel and the end side Y is arranged on the toe side.
　更に、同じ被験者で、貼り付け用サンプルの貼付部位を左肩に変更して、同様の方法で血流の測定を行った。なお、貼り付け用サンプルを左肩に貼り合わせる場合には、図３のＡに示す頂点Ｘが左肩の首側、端辺Ｙが左腕側に配されるにした。 Furthermore, in the same subject, the attachment site of the attachment sample was changed to the left shoulder, and blood flow was measured by the same method. When the sticking sample is stuck to the left shoulder, the apex X shown in FIG. 3A is arranged on the neck side of the left shoulder and the end side Y is arranged on the left arm side.
３．結果
　結果を表４に示す。還元鉄を含む発熱体と、透湿度が３００～１２００ｇ／ｍ2・ｄａｙである透湿性シートを使用した温熱治療用の医療機器では、足底部に適用すると、手、足、及び肩の全体の血流量の増加が認められ、全身に対して優れた温熱効果を付与できていた（実施例１～４）。とりわけ、透湿度が６５０～１２００ｇ／ｍ2・ｄａｙである透湿性シートを使用した温熱治療用の医療機器では、全身に及ぼす温熱効果が卓越していた(実施例１～３)。これに対して、未還元鉄を含む発熱体を使用した場合には、透湿性シートの透湿度にかかわらず、足底部に適用すると、手や足の血流量が増加していなかった（比較例１～５）。また、還元鉄を含む発熱体と、透湿度が３００～１２００ｇ／ｍ2・ｄａｙである透湿性シートを使用した温熱治療用の医療機器でも、肩に適用すると、手の血流量を増大させることはできず、全身に温熱効果を付与することはできなかった。 3. Results The results are shown in Table 4. When applied to the sole of a medical device for thermotherapy using a heating element containing reduced iron and a moisture-permeable sheet having a moisture permeability of 300 to 1200 g/m 2 ·day, it can be applied to the entire hands, feet, and shoulders. An increase in blood flow was observed, and an excellent thermal effect on the whole body could be imparted (Examples 1 to 4). In particular, in the medical device for thermotherapy using the moisture permeable sheet having a moisture vapor transmission rate of 650 to 1200 g/m 2 ·day, the thermal effect on the whole body was excellent (Examples 1 to 3). On the other hand, when a heating element containing unreduced iron was used, the blood flow in the hands and feet did not increase when applied to the sole of the foot, regardless of the moisture permeability of the moisture permeable sheet (Comparative Example 1-5). In addition, a medical device for hyperthermia treatment that uses a heating element containing reduced iron and a moisture-permeable sheet with a moisture permeability of 300 to 1200 g/m 2 ·day can increase blood flow in the hand when applied to the shoulder. It was not possible to give a heat effect to the whole body.
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
１　収容体
１１　収容体において発熱体を収容する収容部
１２　収容体において張り合わせ部分を構成する端部（シール部） DESCRIPTION OF SYMBOLS 1 Storage body 11 Storage part 12 which stores a heating element in a storage body 12 End part (sealing part) which comprises the bonding part in a storage body

Claims (7)

  1. 　足底部の少なくとも一部に配設して使用される温熱治療用の医療機器であり、
    　足底部に伝える熱を発生させる発熱部と、
    　前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体と、を有し、
    　前記発熱部が還元鉄粉を含み、且つ
    　前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである、
    温熱治療用の医療機器。     A medical device for thermotherapy, which is used by being disposed on at least a part of the sole,
    A heat generating part that generates heat that is transferred to the sole of the foot,
    And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
    The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day.
    Medical equipment for hyperthermia.
  2. 　発熱部が、更に酸化促進剤及び水を含む、請求項１に記載の温熱治療用の医療機器。 The medical device for hyperthermia treatment according to claim 1, wherein the heat-generating part further contains an oxidation promoter and water.
  3. 　前記透湿性シートが、細孔を有する通気性樹脂層と繊維基材との積層シートである、請求項１又は２に記載の温熱治療用の医療機器。 The medical device for thermotherapy according to claim 1 or 2, wherein the moisture permeable sheet is a laminated sheet of a breathable resin layer having pores and a fiber base material.
  4. 　前記収容体の一方の面に粘着層が設けられている、請求項１～３のいずれかに記載の温熱治療用の医療機器。 The medical device for thermotherapy according to any one of claims 1 to 3, wherein an adhesive layer is provided on one surface of the container.
  5. 　体全体に対して温熱効果を付与するために使用される、請求項１～４のいずれかに記載の温熱治療用の医療機器。 The medical device for thermotherapy according to any one of claims 1 to 4, which is used for imparting a thermal effect to the whole body.
  6. 　足底部の少なくとも一部に配設して使用される温熱治療用の医療機器の製造のための、化学カイロの使用であって、
    　前記化学カイロが、
    　足底部に伝える熱を発生させる発熱部と、
    　前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体と、を有し、
    　前記発熱部が還元鉄粉を含み、且つ
    　前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである、
    前記使用。     Use of a chemical warmer for the manufacture of a medical device for hyperthermia, which is used by being disposed on at least a part of the sole,
    The chemical body warmer
    A heat generating part that generates heat that is transferred to the sole of the foot,
    And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
    The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day.
    Said use.
  7. 　温熱治療が必要とされる者の足底部の少なくとも一部に化学カイロを配設する工程を含む温熱治療方法であって、
    　前記化学カイロが、
    　足底部に伝える熱を発生させる発熱部と、
    　前記発熱部を収容し、少なくとも一方の面に透湿性シートを含む収容体と、を有し、
    　前記発熱部が還元鉄粉を含み、且つ
    　前記透湿性シートの透湿度が３００～１２００ｇ／ｍ2・ｄａｙである、
    温熱治療方法。     A thermotherapy method comprising the step of disposing a chemical warmer on at least a part of the sole of a person who requires hyperthermia,
    The chemical body warmer
    A heat generating part that generates heat that is transferred to the sole of the foot,
    And a container containing the heat generating part and including a moisture-permeable sheet on at least one surface thereof,
    The heat generating part contains reduced iron powder, and the moisture permeability of the moisture permeable sheet is 300 to 1200 g/m 2 ·day.
    Heat treatment method.
PCT/JP2019/048102 2018-12-28 2019-12-09 Warming treatment medical device WO2020137492A1 (en)

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CN201980077876.7A CN113164279A (en) 2018-12-28 2019-12-09 Medical device for thermotherapy

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JP2018248612A JP7343975B2 (en) 2018-12-28 2018-12-28 Medical equipment for thermal therapy
JP2018-248612 2018-12-28

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WO1995017864A1 (en) * 1993-12-28 1995-07-06 Kiribai Chemical Co., Ltd. Throwaway body warmer for footwear
JPH09276317A (en) * 1996-04-11 1997-10-28 Genchi Kenkyusho:Kk Heating element for foot warmer and method for producing the same
JP2004512141A (en) * 2000-10-30 2004-04-22 エスケー　ケミカルズ　カンパニー　リミテッド Sheet-shaped heating element and method of manufacturing the same
WO2006006658A1 (en) * 2004-07-14 2006-01-19 Mycoal Products Corporation Heating element for foot warming and process for producing the same

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JP3344686B2 (en) * 1995-07-08 2002-11-11 株式会社元知研究所 Ink-like or cream-like heat-generating composition, heating element using the same, and method for producing this heating element
JP4789585B2 (en) * 2004-12-13 2011-10-12 花王株式会社 Physiological function improvement tool
JP5828615B2 (en) * 2009-09-28 2015-12-09 小林製薬株式会社 Heating tool
JP5202699B2 (en) * 2011-07-12 2013-06-05 小林製薬株式会社 Thermal therapy device
CN108289754B (en) * 2015-09-11 2021-09-07 小林制药株式会社 Heating appliance
JP2017170114A (en) * 2016-03-18 2017-09-28 花王株式会社 Hyperthermia tool
WO2017191681A1 (en) * 2016-05-02 2017-11-09 小林製薬株式会社 Heat generator

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Publication number Priority date Publication date Assignee Title
JPH0675437U (en) * 1993-04-12 1994-10-25 マイコール株式会社 Disposable body warmers used in footwear
WO1995017864A1 (en) * 1993-12-28 1995-07-06 Kiribai Chemical Co., Ltd. Throwaway body warmer for footwear
JPH09276317A (en) * 1996-04-11 1997-10-28 Genchi Kenkyusho:Kk Heating element for foot warmer and method for producing the same
JP2004512141A (en) * 2000-10-30 2004-04-22 エスケー　ケミカルズ　カンパニー　リミテッド Sheet-shaped heating element and method of manufacturing the same
WO2006006658A1 (en) * 2004-07-14 2006-01-19 Mycoal Products Corporation Heating element for foot warming and process for producing the same

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TW202031216A (en) 2020-09-01
CN113164279A (en) 2021-07-23
JP7343975B2 (en) 2023-09-13
JP2020108423A (en) 2020-07-16

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