Medical devices for generating heat and methods of treatment using the same

Abstract

To provide a method and a device for using and disposing an improved alkali metal patch in a treatment method including generation of heat in a treatment region selected for medical and / or cosmetic purposes.SOLUTION: The device includes an impermeable backing layer 12, and an adhesive layer 14 in contact with the backing layer 12. The device includes an alkali metal 16, selected from a single free alkali metal 16 and an alloy of alkali metals 16, in contact with at least a portion of the adhesive layer 14 and defining a treated area. The device includes a release liner 20 in contact with the adhesive layer 14 and the treated area.SELECTED DRAWING: Figure 1B

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 62 / 946,135, filed December 10, 2019, which is incorporated herein by reference in its entirety.

[0002] (Technical field) The technology described herein relates generally to methods and devices for using and disposing of alkali metal patches in therapeutic procedures involving the generation of heat in selected treatment areas for medical and / or cosmetic purposes. [Background technology]

[0003] Devices that rely on exothermic reactions as their own heat source are known to consumers, for example in the form of disposable hand and foot warmers. Such devices contain a reaction mixture that produces heat when water or oxygen is introduced into the reaction mixture.

[0004] Heat producing devices are used in medical situations such as ablation of tissue or cells for cauterization of a wound. Cauterization is a medical procedure used to stop blood flow and aid in sealing the surface of a wound. Various conventional devices for cauterization include electronic and laser cauterizers, which act to destroy tissue while rapidly assisting in clotting of severed blood vessels at the wound. Such cauterization devices do not rely on an exothermic chemical reaction as a heat source.

[0005] Heat can also be used to sterilize surfaces. For example, various devices and methods are used to sterilize surgical instruments (e.g., autoclaves) and other surfaces such as a patient's skin or a surgeon's hands, including non-heated devices such as sterile wipes, antibacterial solutions, and the like. Instrument sterilization techniques typically use heat for extended periods of time to help kill bacteria and other pathogens on the instruments. Sterilization techniques used on human skin or other surfaces rely on chemical interactions between the applied material and the pathogens themselves to kill the pathogens.

[0006] Medical systems such as bandages are traditionally used to alleviate bleeding by applying pressure to the wound and by assisting the blood's natural clotting process involving platelets and fibrin in the blood. Bandages are also used to help prevent additional bacteria and other harmful substances from entering an open wound. Bandages used to cover wounds typically include a sterile portion, such as a gauze pad or other sterile structure, that is either directly attached to the bandage or attached to the wound by the bandage.

[0007] It is desirable to have a device that includes a reactant capable of generating heat by exothermic reaction with a reactant at or on a treatment site, such as human skin or tissue, for use in a variety of applications, such as treating certain diseases corresponding to cardiac rupture, treating skin conditions, and sterilizing or disinfecting skin areas for treatment. Summary of the Invention

[0008] In a first embodiment, a device is provided comprising an impermeable backing layer and an adhesive layer in contact with the backing layer, an alkali metal selected from a single alkali metal and an alloy of alkali metals in direct or indirect contact with at least a portion of the adhesive layer, the alkali metal defining a treatment region, and a release liner in contact with the adhesive layer and the treatment region.

[0009] In a second aspect, a thermal delivery system is provided that includes a container that is substantially impermeable to water, oxygen, or both, and a device removably disposed in the container. The device in the thermal delivery system includes a backing layer, an adhesive layer in contact with the backing layer, and an alkali metal selected from a single alkali metal and an alloy of alkali metals. The alkali metal is in contact with the adhesive layer to define a treatment region. The device in the thermal delivery system also includes a removable release liner in contact with the adhesive layer.

[0010] In a third aspect, there is provided a kit comprising a thermal delivery system including a device removably disposed in a container substantially impermeable to water, oxygen, or both, the device comprising a backing layer, an adhesive layer, and an alkali metal selected from a single alkali metal and an alloy of alkali metals in contact with the adhesive layer, the alkali metal defining a treatment area. Such kits optionally comprise one or more wipes (optionally including a solvent or reagent). The kit also comprises means for disposing of the device.

[0011] In yet another aspect, a method for treating hyperhidrosis is provided that includes providing a device removably disposed in a container that is substantially impermeable to water, oxygen, or both. The device includes a backing layer, an adhesive layer, and an alkali metal selected from a single alkali metal and an alloy of alkali metals in contact with the adhesive layer, defining a treatment area. The device also includes a release liner in contact with the treatment area. The method includes removing or providing instructions for the release liner to be removed; and applying the device to skin or tissue of a human subject, whereby the treatment area is in contact with the skin or tissue at the treatment site, whereby moisture on or in the skin or tissue reacts with the alkali metal to generate heat (or an amount of heat) and reduce sweat production (or sweat production or sweat product) at the treatment site (or generate an amount of heat such that sweat production at such treatment site is reduced). [Brief description of the drawings]

[0012] [Figure 1A] FIG. 1A shows a plan view (FIG. 1A) of a device for contacting a treatment site on the human body for medical and / or cosmetic applications to generate heat at a desired treatment area, according to some embodiments.

[0013] [Figure 1B] FIG. 1B shows a cross-sectional view (FIG. 1B) of a device for contacting a treatment site on the human body for medical and / or cosmetic applications, according to some embodiments, to generate heat at a desired treatment area.

[0014] [Figure 1C]FIG. 1C shows a cross-sectional view (FIG. 1C) of a device for contacting a treatment site on the human body for medical and / or cosmetic applications, according to some embodiments, to generate heat at a desired treatment area.

[0015] [Figure 2A] FIG. 2A illustrates an exploded view of an embodiment of a device for generating heat, according to some embodiments, showing multiple layers of materials.

[0016] [Figure 2B] FIG. 2B illustrates an exploded view of an embodiment of a device for generating heat, according to some embodiments, showing multiple layers of materials.

[0017] [Diagram 3] FIG. 3 illustrates the human body and treatment sites to which a heat generating device may be applied, according to some embodiments.

[0018] [Figure 4] FIG. 4 illustrates a system comprising a heat generating device, according to some embodiments.

[0019] [Diagram 5] FIG. 5 illustrates a kit including a heat generating device for thermal medical or cosmetic treatment, according to some embodiments.

[0020] [Figure 6] FIG. 6 illustrates a kit for disposing of a heat generating device after use, according to some embodiments.

[0021] [Figure 7]FIG. 7 is a flow chart illustrating method steps for medical or cosmetic treatment using a heat generating device, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] The devices disclosed herein contain an alkali metal (e.g., an alloy of lithium, sodium, potassium, rubidium, cesium, francium, or combinations thereof) that provides an approach for the efficient treatment of certain skin conditions, such as hyperhidrosis or other medical or cosmetic (or "cosmetic") skin conditions. The reaction of the alkali metal with moisture at or on the skin or tissue at the treatment site generates a certain amount of heat for therapeutic or cosmetic applications.

[0023] The devices can also be used to substantially sterilize, disinfect, or render substantially sterile surfaces (human skin or tissue surfaces, or other surfaces such as surgical instruments, laboratory bench tops, petri dishes, etc.) Whether used in the controlled environment of a medical facility (e.g., hospital, clinic, doctor's office, etc.) or in a laboratory or home setting, an approach for safe and easy disposal of the devices is provided.

[0024] In the device, the alkali metal is present in an amount sufficient to generate heat, which occurs when the alkali metal comes into contact with water or another oxidizing agent. Typically, the alkali metal comes into contact with water or another oxidizing agent when it is applied to the surface to be treated, as described below. As used herein, "alkali metal" refers to a monovalent metal or alloy of such metals belonging to Group 1A of the periodic table, essentially or substantially in free form (or free from), or in its pure or neat form. Such alkali metals include potassium, sodium, lithium, rubidium, cesium, and francium. As can be understood, due to the reactivity of the free alkali metal, a portion of the free alkali metal reacts with oxygen to form an oxide. Thus, it is contemplated that references herein to free form alkali metal, pure form alkali metal, and the like may include a small portion of the free or pure alkali metal that is oxidized. Also, if an alkali metal undergoes an exothermic reaction in the presence of water, a reference to an "alkali metal" or a specific metal (e.g., potassium metal or sodium metal) includes its oxide, peroxide, superoxide, and hydroxide. A reference to an "alkali metal salt" is intended to mean compounds of alkali metals and other elements that are water-soluble and generally do not react exothermically with water, such as sodium chloride, potassium chloride, sodium carbonate, etc. An alkali metal alloy is intended to mean a combination of two or more pure or free alkali metals.

[0025] Upon reaction of the alkali metal with water, e.g., upon use of the device where the alkali metal comes into contact with moisture, sweat, or another water source, energy (e.g., heat) is generated due to the exothermic reaction of the water with the alkali metal. In some embodiments, moisture, sweat, or other water sources present in, on, or otherwise associated with the device are separate from the device itself for reaction with the alkali metal. The energy is transferred to a treatment surface, such as a human skin or body surface, to provide a clinical or cosmetic benefit. In some embodiments, the device (also referred to herein as a "patch") is configured for single-use and is disposable. In single-use, some of the alkali metal may remain unreacted, e.g., some of the alkali metal remains available to react with water. Therefore, in some embodiments, it is desirable to have a simple and safe method of reacting unused or unreacted portions of alkali metal to render them safe for disposal in a conventional manner (e.g., by mixing into a solution that can be flushed or placed in a trash container).

[0026] In one embodiment, the alkali metal is potassium or sodium. In another embodiment, the alkali metal is a neat alkali metal, often also referred to as a free metal, such as potassium-free metal or sodium-free metal. In another embodiment, the alkali metal is potassium or sodium in the oxide form, such as sodium monoxide (Na 2 O) and sodium peroxide (Na 2 O 2 ) and sodium superoxide (NaO 2). Sodium metal is a soft metal that is highly reactive with oxygen and water. Due to its softness, sodium metal can be cut, broken, and shaped into various shapes. Potassium metal is similarly a soft metal that is more reactive with oxygen and water than sodium metal. In some embodiments, the alkali metal is in a solid or semi-solid state at room temperature (e.g., about 25°C).

[0027] In another embodiment, the alkali metal is an alloy, such as, for example, an alloy of sodium and potassium. Sodium metal and potassium metal can combine to form a sodium / potassium alloy (NaK) that is liquid at room temperature. NaK, which is liquid at room temperature, contains about 40% to about 90% potassium by weight. A eutectic of sodium and potassium occurs at about 77% potassium and about 23% sodium, at which point the liquid metal is less dense than water. Eutectic compositions may be used in various embodiments of the devices of the present disclosure, as well as any combination of sodium and potassium in a ratio that forms a stable alloy. Thus, the term "NaK" is used herein to refer to an alloy of sodium and potassium, and as such term is used herein to refer to any possible combination of sodium and potassium, not just a 50 / 50 atomic mixture, but also a eutectic composition. In some embodiments, the alloy of the alkali metal is solid or semi-solid at room temperature (e.g., about 25°C).

[0028] The reaction of an alkali metal compound (e.g., sodium Na, potassium K) with water (e.g., the “reactant” or “solubilizer”) can be represented by the following chemical equation: TIFF2025081691000002.tif15170

[0029] The reaction of Equation 1 (Na is taken as an example for illustrative purposes only) is a highly exothermic reaction. The methods and devices disclosed herein utilize the above heat-generating (e.g., energy) effect for therapeutic purposes in the desired treatment area of ​​the patient. Furthermore, after use of the devices or patches disclosed herein, in some embodiments, various solutions are provided to convert the alkali metal residues of the used devices or patches into other non-pyrophoric substances, such as metal hydroxides, metal alkoxides, or salts (e.g., alkali halides such as NaCl and the like).

[0030] 1A-1C show plan and cross-sectional views (FIGS. 1B-1C) of an embodiment of a device 10 for generating heat. Device 10 is in the form of a wearable patch having a backing layer 12, an adhesive layer 14 in contact with the backing layer, and an alkali metal 16. In one embodiment, the alkali metal is selected from an essentially or substantially pure single free metal, or an alloy of alkali metals (wherein each alkali metal in the alloy is a free alkali metal). In some embodiments, the alkali metal or alkali alloy is essentially or substantially pure or free alkali metal, where the free alkali metal is intended to be at least about 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97% or 98% by weight free alkali metal and the remainder alkali metal in oxidized or hydroxide form. The alkali metal is in contact with at least a portion of the adhesive layer and defines a treatment region 18. The treatment region 18 is shown in phantom in FIG. 1A, and in the plan view of FIG. 1A, the backing layer 12 would obscure the alkali metal 16 unless it were transparent. The patch in this embodiment comprises a release liner 20 in contact with the adhesive layer. In some embodiments, the alkali metal, adhesive layer, and backing layer form a substantially planar treatment device that is applied to a treatment surface, such as a body surface. Each layer of the treatment device (alkali metal, adhesive layer, backing layer) remains in contact with the other during application and use of the device. In some embodiments, the device is not a syringe or needle.

[0031] In some embodiments, the alkali metal 16 is selected from pure sodium and pure potassium. In some embodiments, the alkali metal may include an alloy of pure alkali metals (or free alkali metals) selected from sodium and potassium. In some embodiments, the alkali metal and alloy may be partially in the form of an oxide. For example, in some embodiments, oxidation of a small amount of the alkali metal may be unavoidable. In some embodiments, the alkali metal includes a population of particles embedded in a matrix, which may be adhesive matrix 14, as seen in FIG. 1B. In other embodiments, the alkali metal 16 is in direct contact with adhesive layer 14, as shown in FIG. 1C. In other embodiments, the alkali metal 16 and adhesive layer 14 are in indirect (non-direct) contact with one or more intervening layers disposed therebetween, not shown. In some embodiments, the alkali metal 16 is a continuous layer or film (or foil, as described below) having a first surface and a second surface. A support material is secured to one of the first and second surfaces, for example an adhesive laminate support material, placed directly on one side of the alkali metal layer, thereby forming a composite of the alkali metal layer and the adhesive laminate. A backing layer 12, which may itself be a laminate of adhesive and backing material (e.g., paper, fabric, nonwoven, foil, expanded foam, plastic film, polymer film), is secured to the composite to form the device.

[0032] In some embodiments, the layer of alkali metal is a foil, where the alkali metal is in the form of a metal sheet, hi some embodiments, the alkali metal 16 is a continuous layer of the desired shape. In certain embodiments, the alkali metal layer has a thickness of about 0.01-8 mm, 0.01-6 mm, 0.01-5 mm, 0.015-5 mm, 0.02-5 mm, 0.02-4.5 mm, 0.02-4 mm, 0.02-3.5 mm, 0.02-3 mm, 0.02-2.5 mm, 0.025-5 mm, 0.025-4.5 mm, 0.025-4 mm, 0.025-3.5 mm, 0.025-3 mm, 0.025-2.5 mm, 0.03-5 mm, 0.03-4.5 mm, 0.03-4 mm, 0.03-3.5 mm, 0.03-3 mm, or 0.03-2.5 mm. In other embodiments, the layer can have any desired thickness or any desired geometric shape (e.g., oval, diamond, parallelogram, salt, crescent, triangle, octagon, heptagon, rectangle, and the like). The patch can be shaped to resemble or mimic a target body part or portion thereof. Thus, in some embodiments, the patch is shaped as a part of a palm, finger, hand, underarm, sole, or the like. In other embodiments, the patch is comprised of a plurality of individual patch parts, each having an individual shape and configured to be arranged such that the parts resemble or mimic a desired shape. The desired shape can be a geometric shape such as those described above, or it can be the shape of a body part. The individually shaped parts or members can be the same or different shapes, provided that they collectively achieve the desired shape when arranged.

[0033] The shape or dimensions of the alkali metal layer define a treatment region that is intended to contact (or be in contact with) a skin, tissue or other surface to receive a thermal treatment, as described below. In some embodiments, the treatment region has a length and a width, or the treatment region has a diameter, and the back layer has a length (or a longer length) and width that are greater than the length and width of the treatment region, or the back layer has a diameter (or a longer diameter) that is greater than the diameter of the treatment region. Such embodiments are illustrated in various embodiments of the device shown in Figures 1A-1C, where the back layer 12 is sized to extend over the length 1 of the oval-shaped treatment region 18. 1 and width w 1 The backing layer has a length l and a width w that are greater than 10%, 15%, 20%, 25% or 30% greater than one or more dimensions of the backing layer (e.g., length, width and / or diameter of the treated area), e.g., 10%, 15%, 20%, 25% or 30% greater than one or more dimensions of the length, width and / or diameter of the treated area. In some embodiments, the device is a planar device. In some embodiments, the adhesive layer in contact with the alkali metal is a planar adhesive layer.

[0034] It will be appreciated that the dimensions of the treatment region can be selected and optimized for the treatment site on the body. For example, the treatment region may be (or be designed to be) in contact with the treatment site in the armpits (under the arms), chest, palms, soles, groin, or forehead. The treatment region of the device may have the same or different geometry as other layers of the device, or may have the same or different dimensions as other layers of the device. For example, where the treatment region has a geometry and the back layer has a geometry, the geometry of the treatment region may differ from the geometry of the back layer. For example, in some embodiments, the treatment region has an oval geometry and the back layer has a rectangular geometry. The treatment region has an area and the back layer has an area that overlaps with the treatment region but may not be the same as it. For example, in some embodiments, the area of ​​the treated region is at least 10% smaller than the area of ​​the backing layer.

[0035] The release liner of the device has a length and width that is the same as or greater than the length and width of the treated area, or a diameter that is the same as or greater than the diameter of the treated area. Referring to FIG. 2A, the device 22 is comprised of a back layer 24, an adhesive layer 26 in direct or indirect contact with the back layer 24, and an alkali metal 28 in contact with at least a portion of the adhesive layer. The area on the adhesive layer where the alkali metal is dispersed or extended defines the treated area 30, which in the embodiment of FIG. 2A is a circular area. The dimensions of the release liner 32 are adapted to have substantially the same dimensions as the adhesive layer 26. In this embodiment, the dimensions of the release liner 32 are adapted to have substantially the same dimensions as the back layer. The release liner 32 is adapted to have a length and width that is greater than the length and width of the back layer d. 2 Substantially the same dimension as d 1The release liner is removed by a user of the device to expose the treated area 30 and adhesive layer 26. The adhesive layer may be a peripheral adhesive around the treated area such that the treated area is defined, or it may be a continuous adhesive layer with alkali metal foil or alkali metal particles laminated or incorporated into a portion of the adhesive layer such that the treated area is defined. In the embodiment of FIG. 2B, the device 36 is comprised of a backing layer 38, an adhesive matrix 40, an alkali metal foil 42, and a release liner 44. The release liner 44 is a layer of length l 1 and width w 1 The back layer 38 has a length l of the release liner. 1 Length less than l 2 The back layer 38 has a width w of the release liner. 1 Practically the same width as w 2 In some embodiments, the release liner has a length and width greater than the length and width of the adhesive layer, or a diameter greater than the diameter of the adhesive layer. In some embodiments, the release liner and the backing layer have substantially the same length and width, or substantially the same diameter, in both cases greater than the length and width of the treated area, or greater than the diameter of the treated area. In some embodiments, the release liner may be in contact with (or on) the adhesive layer and may cover the treated area. Additionally, in some embodiments, the release liner may extend up to or beyond the boundary of the adhesive layer and may cover the treated area.

[0036] The device of FIG. 2B includes a release or lift tab 46 to allow for easy separation of the release liner from the device. In one embodiment, the tab 46 corresponds to a portion of the adhesive layer that is covered with a non-adhesive material. In another embodiment, the tab 46 is formed using a paper or material having opposing sides, such as an upper side 48 and a lower side 50, where one or both of the upper and lower sides are treated with a material that is non-adhesive or adhesive to the adhesive layer.

[0037] The backing layer of the devices described herein is generally formed from a material that is water impermeable, oxygen impermeable, or both water and oxygen impermeable. The backing layer may be transparent or colored. In some embodiments, the backing layer is stretchable to accommodate the wearable device on a desired portion of the body. In some embodiments, the stretchable backing layer is impermeable to water, oxygen, or both, and is a laminate of a woven or nonwoven fabric and an impermeable material, where the woven or nonwoven fabric can be at least about 2.5%, 3%, 3.5%, 4%, or 5% longer or wider in one or more directions. For example, in some embodiments, the backing layer is a transparent, adhesive coated polyolefin. The polyolefin can be polyethylene, polypropylene, polymethylpentene, polybutene, and olefin elastomers such as polyisobutylene, ethylene propylene rubber, and the like. The backing layer can comprise an adhesive, such as an acrylate adhesive. The backing layer has opposing sides and an adhesive layer is coated on one side of the backing layer.

[0038] The adhesive layer of the devices described herein is generally a pressure-sensitive adhesive. The pressure-sensitive adhesive layer may comprise a hydrophobic adhesive. The hydrophobic adhesive is formed from an acrylic acid monomer or an acrylate monomer. The acrylate monomer is selected from the group consisting of methyl acrylate, methyl methacrylate, ethyl acrylate, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, and 2-chloroethyl vinyl ether (or 2-chloroethyl vinyl ether). The hydrophobic adhesive is a polyacrylate.

[0039] The alkali metal is laminated to, incorporated into, embedded in, or in contact with the adhesive layer. In some embodiments, the alkali metal is located at or on the adhesive layer to contact the skin of a patient or subject for medical or cosmetic treatment. The alkali metal may be attached to the pressure-sensitive adhesive layer as a foil layer. The alkali metal may be dispersed in or on an adhesive matrix that is in contact with (or in contact with) the pressure-sensitive layer, or may be embedded in or incorporated on the adhesive matrix.

[0040] The release liners of the devices described herein are generally thermoplastic polyolefin or polyester materials having opposing sides, one of which is coated with a releaseable coating material. The polyolefin material can include polyethylene or polypropylene. In some embodiments, the polyester material is polyethylene terephthalate. In some embodiments, the release coating material comprises silicone.

[0041] As mentioned above, in some embodiments, the device or release liner may include a lift tab to aid in placement of the wearable patch on the desired body area. The lift tab may be formed by inserting a material between an edge portion of the adhesive layer and the release liner. In some embodiments, the lift tab material has opposing sides, where one of the opposing sides is coated with a material that is non-adherent to the adhesive layer. The lift tab material may also have opposing sides, where at least one of the opposing sides is coated with a material that is adhesive to the adhesive layer.

[0042] FIG. 3 illustrates a human body 60 and multiple treatment areas to which the devices described herein may be applied, according to some embodiments. The treatment areas may include arm pits 62, chest 64, and facial areas 66, such as the forehead and under-eye areas, cheeks, and chin (e.g., cosmetic applications). In some embodiments, the devices disclosed herein may be applied to extremities, such as arms 68, legs 70, hands 72, and feet 74. More generally, devices for medical or cosmetic treatment using heat, as disclosed herein, may be used on wounds, cuts, rashes, and other cutaneous lesions on any part of the body surface. The devices may also be applied to undamaged or unbroken skin or tissue, including mucosal tissue.

[0043] FIG. 4 shows a system 80 including a container 82 and a device 84 described herein for thermal medical or cosmetic treatment. The container is user-openable, such as through a sealed opening 86 along an edge or side of the container. The device 84 is removably disposed within the container. The container is preferably a protective container, which protects the device from contact with oxygen and / or water (moisture) due to the container being impermeable to water and / or oxygen. The sealed opening 86 is sealed such that it is impermeable to water and / or oxygen. In some embodiments, the removable seal includes a hermetic seal, such as a zip-lock. The device may be a wearable patch including a backing layer described herein, an adhesive layer, and an alkali metal selected from a single free alkali metal and an alloy of two or more free alkali metals. The system may also include instructions 88 for use, such as printed instructions 88 including handling instructions, guiding the user through application and disposal of the device. In some embodiments, the instructions 88 may include a printed bar code or quick response (QR) code that the user can scan with a smartphone to access a network source. The network source may include identification information for the device, handling instructions, disposal instructions, and / or other data of interest or relevance to the user, such as inventory data, health and material safety information, and how to use the device.

[0044] FIG. 5 shows a kit 90 consisting of a heat generating device 92 as described herein in a protective container 94 of FIG. 4. The impermeable container may have a removable or openable seal 96 to allow a user to access the device and, optionally, instructions for use 98. The kit may optionally include a wipe 100 and / or a solvent 102, which may be separate (as shown) or may be combined with one another (e.g., the solvent may be provided on or within the wipe). In some embodiments, the kit may be provided with a wipe and / or solvent for cleaning and / or treating a treatment site on a subject prior to the device being used in the kit to heat treat the subject. In some embodiments, the kit may be provided with a substantially dry wipe capable of absorbing waste or moisture from a treatment surface. The wipes may be, for example, disposable absorbent pads or substrates, woven, knitted or nonwoven cloth or fabrics, natural or synthetic fiber articles, and other articles that absorb water. In another embodiment, the wipes are included in the kit pre-moistened with a cleaning reagent or solvent. The pre-moistened wipes may be packaged in a pouch or liquid-tight packaging unit for opening by the user or health care provider. In some embodiments, the cleaning reagent or solvent does not foam or lather upon application to the treatment site. The solvent or reagent for treating or cleaning the treatment site may be any solvent or reagent suitable for application to the skin to remove, for example, dirt, debris, oil, cosmetics, and / or bacteria. In some embodiments, the pre-moistened wipes are substantially free of water.The wipe may be pre-moistened with a solvent or reagent, or the wipe may be pre-moistened with a solvent or reagent in a container, where such a solvent or reagent may be an alcohol, such as isopropyl alcohol or ethanol.

[0045] In another embodiment, the kit optionally comprises a cleanser and wipe for cleaning the treatment site on the subject after the thermal treatment in which the device in the kit was used. The cleanser and wipe may be present as separate elements in the kit, for example, a vial or bottle may be provided with the cleanser and a separate wipe (e.g., gauze, woven or non-woven fabric, or absorbent substrate). The cleanser and wipe may be combined to form a cleaning wipe, where the cleanser is provided on or within the wipe. The cleaning wipe may be packaged in a sealed, sealed, fluid-tight container that can be opened by the user to remove the cleaning wipe, and the cleaning wipe may be partially or fully saturated with the cleanser. In one embodiment, the kit comprises a wipe and a solvent (either as combined elements or as separate elements) for cleaning and / or treating a treatment site on a subject prior to thermal treatment when a device is used in the kit, and a second cleanser and wipe (either as combined elements or as separate elements) for cleaning a treatment site on a subject after thermal treatment when a device is used in the kit. In another embodiment, the kit comprises a single wipe and solvent (either as combined elements or as separate elements) suitable for cleaning and / or treating a treatment site on a subject both prior to and after thermal treatment when a device is used in the kit. In another aspect, the single wipe and solvent (either as a combined element or as a separate element) is suitable for cleaning and / or treating a treatment site on a subject / object either prior to or after thermal treatment using the device in the kit.

[0046] In some embodiments, the kit comprises a wipe and a solvent or reagent (whether as combined elements or as separate elements) that neutralizes reaction products (as described above) that arise during treatment with the device and are brought to the skin or mucosal surface during treatment. In particular, hydroxides may arise during use of the device and remain present at the treatment site. For example, the reaction products may be sodium or potassium hydroxide, and may be sodium or potassium hydroxide based on the alkali metal used in the device. The kits and methods described herein may comprise a solvent or reagent that removes, neutralizes and / or reduces the pH of the hydroxide reaction products. Examples of solvents or reagents include weak acids such as citric acid and acetic acid.

[0047] In some embodiments, the kit comprises a disposal container 104 for disposing of the device after use. The disposal container 104 comprises a sealable compartment 106 sized to receive a used device, and a reagent compartment 108. The reagent compartment contains or is configured to receive and contain a reagent 110. The reagent 110 may be placed in a carrier or directly in the reagent compartment. In some embodiments, a wipe 100 and solvent 102 are provided in the kit for use in the disposal container, as described further below, where the wipe is a carrier for the solvent, which is a reagent. In such embodiments, the wipe soaked in the solvent can be placed by the user in the reagent compartment 108 of the disposal container. A wall 112 separates the sealable compartment 106 from the reagent compartment 108, and the wall 112 is preferably impermeable to the reagent. The wall may include a reagent permeable region 114, such as a porous membrane that allows the passage of reagents placed on a carrier (wipe) to allow the reagent to enter the sealable compartment once the used device is placed in place. In some embodiments, the reagent is a solvent that evaporates above room temperature, allowing the reagent molecules to permeate across the permeable region of the wall and into the sealable compartment. The reagent is selected to react with any unreacted alkali metal in the device, thereby reacting with and neutralizing the unreacted alkali metal and allowing safe disposal. In some embodiments, the sealable compartment is configured to prevent the gas (e.g., H) generated due to the reaction of the alkali metal with the reagent solvent. 2 , see Equation 1) from the sealable compartment.

[0048] The disposal container of the kit is further described with reference to FIG. 6. FIG. 6 shows a disposal kit 120 for disposing of used devices comprising unreacted alkali metal after use. The disposal kit may be configured as a single-use disposal unit (e.g., at least a portion of the kit is disposed of by the user after the used patch is neutralized). In some embodiments, the disposal kit may be configured to receive and neutralize multiple (or multiple) used devices before the disposal kit itself is discarded. In still other embodiments, the disposal kit may be configured to receive and neutralize multiple used devices that are to be removed from the disposal kit when, for example, an indicator means indicates that removal of the used patch from the disposal kit is safe to be performed. In such embodiments, the used and neutralized alkaline device may be removed from the disposal kit and safely discarded, thereby allowing the continued introduction of additional used devices.

[0049] The kit 120 comprises a disposal container 122 having walls defining a cavity 124 and an opening 126 configured to allow receipt of a device within the cavity. In some embodiments, the disposable container is substantially impermeable to water and / or air and has a closable or resealable opening 128. In some embodiments, the closable or resealable opening 128 includes a slide lock (e.g., a ziplock top) or a screw cap to enclose (or seal) the used device 103 in the disposal container. In some embodiments, the disposal container is at least partially formed (or manufactured) from a water-permeable material. In some embodiments, the disposal container may include a polyethylene or polypropylene vial or a polyolefin bag. Additionally, in some embodiments, the disposal container may include at least one wall (e.g., a front wall and a back wall), with the bottom wall attached to the front and back walls. In some embodiments, the disposal container further includes two side walls, each attached to the front and back walls and the bottom wall, with at least one such wall being flexible. In some embodiments, at least one of the walls is circular or curved, with the disposal container including an annular cavity. In some embodiments, at least one of the walls of the container may include metal, metal foil (e.g., stainless steel), polyolefin (e.g., polyethylene terephthalate), or metal-sputtered plastic film.

[0050] In some embodiments, the disposal container includes a reactant 132 that chemically reacts with the unused, unreacted alkali metal of the used device to neutralize the unused, unreacted alkali metal for safe disposal. The reactant may be a solvent that is miscible with water and dissolves the alkali metal. The solvent may include an alcohol or a glycol. In such a case, the alcohol may be an alcohol selected from ethanol, isopropanol, t-butanol, stearyl alcohol, and tris(trimethylsilyl)methanol, and the glycol may be, for example, propylene glycol. In some embodiments, the reactant may be a substantially anhydrous R-OH (-99%) solution (where R is an unspecified chemical group). For example, in some embodiments, the reactant may include ethanol, isopropanol, t-butanol, or a heavier, unconventional, sterically hindered alcohol that has a more predictable and slower reactivity. In some embodiments, the reactant may comprise a low viscosity or gel-like solution and is reacted with an alkali metal. In some embodiments, the water or aqueous solution is contained on or within a carrier such as a sponge, porous body, or absorbent polymeric substrate (or base). In some embodiments, the absorbent polymeric substrate (or base) may be a hydrogel comprising a crosslinked hydrophilic synthetic polymer.In some embodiments, the reactants may include triglycerides, or anhydrous foams, or when reacted with sodium or related metals or alloys in absolute ethanol, they form sodium alginate, sodium difluoride, sodium fluorosilicate, sodium metaborate, sodium paraperiodate, sodium stearate, sodium zirconium glycolate, and sodium perrhenate (NaReO). 4 ). Addition of sodium or other alkali metals will produce nonahydridorhenates. This is a well-behaved reaction that produces inactive salts. In some embodiments, the rhenium (Rh) compounds may be replaced with more affordable materials such as technetium (Tc) or manganese (Mn).

[0051] Additionally, in some embodiments, the kit may include a mechanism for receiving water from an external source. In some embodiments, the reactant is sodium alginate (NaCl), which when reacted with sodium 6 H 7 O 6 ), potassium difluoride (or potassium acid fluoride or potassium hydrogen fluoride) (KHF 2 ), sodium difluoride (NaHF 2 ), Sodium fluorosilicate (Na 2 SiF 6 ), sodium metaborate (NaBO 2 ), Sodium paraperiodate (Na 3H 2 IO 6 ), Sodium stearate (NaOOCC 17 H 35 ) and sodium zirconium glycolate (NaZrH 3 (H 2 COCOO) 3 ) with a counter ion resulting in a compound selected from

[0052] In some embodiments, the mechanism for receiving water from an external source is a water- or moisture-permeable polymeric membrane, shown as 134 in FIG. 6. In addition to water or water and salt solutions, solutions that can be used to limit the rate of the chemical reaction (Equation 1) include propylene glycol (PG), alcohol, and high molar NaOH (aqueous), such as 10 M NaOH, which react slowly with sodium in a controlled manner.

[0053] Additionally, in some embodiments, the reactants may include carbon dioxide, thereby forming an alkali metal carbonate. 2 may be in gaseous form. Alternatively, at least one compartment may be filled with a substance that releases carbon dioxide. Additionally, carbon tetrachloride and dichloromethane react violently with sodium and may be used to expend spent sodium.

[0054] In some embodiments, it may be beneficial to neutralize the products after the alkali metal reaction (see Equation 1). Highly basic alkali hydroxides (e.g., NaOH, see Equation 1) are caustic and can be dangerous to dispose of. Thus, in some embodiments, a buffer, acid, or similar compound may be included in the reaction solution to neutralize or control the reaction products (e.g., the right side of Equation 1).

[0055] One or more walls of the first cavity may include a membrane 134 (FIG. 6) that is selectively permeable to hydrogen. Such a semi-permeable membrane may be a polymer membrane, a porous membrane, a dense metal membrane, or an ion-conducting membrane. Examples of porous membranes include ceramic membranes, carbon membranes, and metal membranes. Examples of polymer membranes include aromatic polyimides, polysulfones, cellulose acetate, polyethylene, and tetrabromopolycarbonate. Examples of dense metal membranes include palladium membranes and palladium-based alloy membranes. The hydrogen-permeable membrane may be a hybrid membrane consisting of nanoparticles dispersed in a polymer matrix, such as those described in Pulyalina A. et al., Polymer (10(8)):828 (2018). Some embodiments allow hydrogen to escape while retaining water vapor or steam. In some embodiments, the alkaline patch may be partially or fully immersed in the reactant (e.g., PG solution). Some embodiments include environmental control within the container so that high humidity levels are provided. For the latter, a membrane or container that vents hydrogen at a higher rate relative to water vapor or steam may be desired.

[0056] In one embodiment, water vapor enters the first cavity of the pouch and proceeds to react with the alkali metal (see Equation 1). Hydrogen exits the pouch through a hydrogen permeable membrane or material. The alkali metal is oxidized and may leave a crust or layer of high molar hydroxide hydrate or alkali hydroxide (e.g., NaOH, see Equation 1) on the used patch, which is safely encapsulated in the first cavity. In another embodiment, the hydrogen permeable membrane has a hydrogen permeation rate or diffusion rate of at least about 10%, 20%, 25%, 30%, 35%, 40%, 50%, 60%, 75% or a higher rate of permeation or diffusion than the rate of water vapor or steam.

[0057] In some embodiments, at least the first cavity in the container may include a wall, at least a portion of which includes a hydrogen-permeable membrane or material (e.g., synthetic polymers, such as those described above, and the like). In some embodiments, the semi-permeable membrane may be permeable to water vapor or steam. The semi-permeable membrane may be disposed on the bottom wall of the container. Hydrogen released by the interaction of the reactant with the alkali metal may be freely vented from the container through the hydrogen-permeable membrane and may be released to the atmosphere. The sealed and enclosed container containing the used patch may be safely disposed of using prescribed procedures. In some embodiments, the container may include a water source or may include a mechanism for receiving water (e.g., the reactant on the left side of Equation 1) from an external water source. In some embodiments, the used patch exposes the alkali metal or its alloy to water or an aqueous solution in a manner that limits the availability of water for reaction with the alkali metal or its alloy, thereby avoiding explosion. In some embodiments, the reactant may include a membrane with a preselected diffusion gradient that allows water (liquid or gaseous form) to slowly permeate into the cavity containing the used patch. In some embodiments, the reactant includes an aqueous solution such as propylene glycol (PG)+water, salt+water, or alcohol+water. In some embodiments, the reactant may include a sponge that allows water to slowly permeate into the cavity at a limited rate to provide a controlled reaction.

[0058] In some embodiments, the reactant may include water or an aqueous solution incorporated into a sintered metal, a porous polymer, a porous plastic, or an absorbent polymeric substrate (e.g., a hydrogel comprising a crosslinked hydrophilic synthetic polymer). More specifically, the sintered metal forms a rate-limiting interface between the reactant solution and the alkali metal in the used patch. Furthermore, since the metal has a relatively large thermal mass, the sintered metal may limit the temperature of the reacting alkali metal below its melting point and below the autoignition temperature of hydrogen. The sintered metal, plastic material, or a combination thereof may provide a tortuous / complex path to limit the rate of water ingress into the cavity containing the used patch. In some embodiments, the reactants may include beads, films, or sheets, which may be comprised of hydrogels, absorbent polymers, superabsorbent polymers, polyvinyl alcohol (PVA), silicone, or any combination of suitable substrates that include water or aqueous solutions.

[0059] In some embodiments, the reactant may include a solution of propylene glycol (PG). Propylene glycol has the advantage that it is miscible with water. It is also flame retardant (or non-flammable) and safe to use. In some embodiments, the reactant may include a 100% PG solution for efficient dissolution of the patch, or a PG / H2O2 solution. 2The alkaline layer of the used patch may have other ratios (or ratios) of 0 to 100%. For embodiments in which the patch has an alkali metal foil sheet (e.g., metal or alloy about 0.0254 mm to 1.3 mm or about 0.1 mm to 0.3 mm), it may take about 30 minutes to 24 hours to completely dissolve the alkali when immersed in a 100% PG solution. The dissolution of the alkaline layer of the used patch is faster with increasing amounts of water in the aqueous PG solution (or aqueous PG solution). In some embodiments, it may be desirable to keep the water level in the aqueous PG solution below about 10%, thereby avoiding excessive heat generation and the formation of small metal beads due to melting of the alkali metal. If the alkali metal beads float to the surface of the solution, they will continue to react with the solution, air, and water vapor, and in some cases the resulting hydrogen may ignite.

[0060] In some embodiments, the concentration of the PG / water solution may be adjusted (e.g., "tuned") to obtain the desired reaction rate. For example, in some embodiments, the concentration of the PG / water solution may be adjusted / tuned so that the rate of hydrogen production is not faster than the rate at which hydrogen is released from the container. Hydrogen is a very small molecule and therefore difficult to contain. Standard containers, such as polyethylene bags with sliding seals (e.g., Ziploc®) or sealable flaps, may successfully contain the used patch and solvent and allow hydrogen to pass through (or a membrane or Tyvek bag may be used as described above). However, if the reaction proceeds too quickly, hydrogen may be formed at a rate that exceeds the rate at which it is released from the container. Thus, in some embodiments, careful selection of the PG to water ratio of the solution may slow hydrogen production to a rate that matches the rate at which hydrogen is released from the container.

[0061] In some embodiments, the reactants, or at least a portion of the disposal kit, may include a color changing material that indicates when the reaction with the alkali metal is complete. More specifically, the reactants, or a portion of the disposal kit, may include a material that physically changes in a perceptible manner to indicate when the reaction is complete. The physical change may be caused by heat, by the pH of the solution, or by the reaction products contained therein, or the like. The color change may indicate to the user when the reaction is complete and when it is safe to dispose of the disposal kit.

[0062] In some embodiments, the disposal kit may contain an excess of a solution having a high heat capacity (or large heat capacity) or the container may include at least a portion of a wall formed from a metal or other material having a high heat capacity.

[0063] In some embodiments, the disposal kit may include a label or leaflet (e.g., such a label or leaflet may be stamped on the outside of one wall, placed loosely inside the container, or attached via a string). The label or leaflet may include a set of instructions 136 for use. In some embodiments, the instructions may be printed directly on the container or may be provided (or printed) on a material that is placed on the adhesive portion of a used patch.

[0064] 7 is a flow chart illustrating steps of a method 150 for applying heat to tissue for a medical or cosmetic treatment, according to some embodiments. The method 150 can be performed using any one of the devices consistent with the present disclosure, such as a wearable patch. In some embodiments, the method 150 includes the use of systems and kits including a wearable device, a reservoir container, a disposal container, a solvent, and reagents, as disclosed herein. Additionally, in some embodiments, a method consistent with the present disclosure can include one or more steps, as disclosed herein, in any order, or can include such steps sequentially, simultaneously, repeatedly, or overlapping in time.

[0065] Step 152 includes providing a heat delivery system including the device removably disposed in a protective, impermeable container. The device may include a backing layer, an adhesive layer, and an alkali metal selected from an alkali metal and an alloy of alkali metals. The alkali metal defines a treatment region. In some embodiments, the heat delivery system includes a release liner in contact with the treatment region.

[0066] Step 154 ​​involves removing or providing instructions that the release liner be removed.

[0067] Step 156 includes applying or instructing the device to be applied to a treatment site on the subject's surface. For example, the treatment site can be the subject's skin or mucosal surface. Application of the device to the surface results in the treatment area having the surface to be treated coming into contact with the device. Moisture on or at the surface to be treated (e.g., skin, mucosal tissue) reacts with the alkali metal to generate heat associated with the treatment. In some embodiments, such treatment reduces or eliminates sweat production (or sweat products) from the subject's skin surface.

[0068] The method optionally includes step 158 of repeating steps 152, 154 or 156 one or more times at a time after the initial step of providing, removing and applying, in some embodiments including at a time after the initial step of 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks or 12 weeks.

[0069] In one embodiment, the method shown in FIG. 7 is for the treatment of hyperhidrosis (excessive sweating), where treatment with the device reduces or eliminates sweat production (or sweat products) from glands below the skin treatment site.

[0070] In some embodiments, the amount of heat generated upon application of the device to the treatment surface is controlled, proportional to, and / or limited by the amount of water at the contact point. In some embodiments, the exothermic reaction ceases when sufficient alkali metal (e.g., sodium-free metal, potassium-free metal, alloys of free alkali metals) is consumed, so that the amount of heat generated can be directly calculated and controlled by the amount of metal involved in the reaction. In some embodiments, the exothermic reaction ceases when the water at the treatment surface is consumed. The amount of heat generated can be controlled by the amount of alkali metal and / or the amount of water available to react with the alkali metal.

[0071] As used herein, a phrase such as "at least one of" preceding a list of items with the term "and" or "or" to distinguish between the items modifies the list as a whole, rather than modifying each member (e.g., each item) of the list. A phrase such as "at least one" does not necessarily require the selection of at least one item, but rather allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the terms "at least one of A, B, and C" or "at least one of A, B, or C" refer to A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0072] As used herein and in the claims, the terms "include," "have," and similar terms are intended to be inclusive in the same manner as the term "comprise" is interpreted when used as a transitional term in the claims. The term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "exemplary" should not necessarily be construed as preferred or advantageous over other aspects.

[0073] Singular elements are intended to mean "one or more" rather than "one and only one" unless specifically stated otherwise. All structural or functional equivalents to the various elements described in this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject technology. Furthermore, nothing disclosed herein is intended to be made publicly available, regardless of whether such disclosure is expressly set forth in the above description.

[0074] Although the specification contains many specific details, these should not be construed as limitations on the scope as defined by the claims, but rather as descriptions of certain particular implementations of the subject matter. Certain features described herein in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a certain combination and may be initially claimed as such, one or more features from a claimed combination may in some cases be removed from the combination, and the claimed combination may be directed to (or be directed to) a subcombination or a variation of the subcombination.

[0075] Although the subject matter of this specification has been described in terms of certain aspects, other aspects may be practiced and still fall within the scope of the appended claims. For example, operations are depicted in a particular order in the figures. However, this should not be construed as requiring such operations to be performed in the particular order or sequential order depicted to achieve desired results, or that all of the depicted operations must be performed. The actions recited in the claims may be performed in a different order and still achieve desired results. As an example, the processes depicted in the accompanying figures do not necessarily require the particular order or sequential order depicted to achieve desired results. In some situations and environments, it may be advantageous to process multiple tasks in parallel. Furthermore, the separation of various system elements in the above aspects should not be construed as requiring such separation in all aspects, and the program elements and systems described above may generally be integrated together into a single software product or packaged into multiple (or multiple) software products. Other variations are within the scope of the following claims.

[0076] In some subject matter, a method may be an operation, instruction, or function, and vice versa. In some subject matter, a claim may be amended to include some or all of a word (e.g., an instruction, operation, function, or element), one or more terms, one or more sentences, one or more phrases, one or more paragraphs, and / or one or more claims of one or more other claims.

[0077] The above description is intended to illustrate various aspects of the present technology. The examples (or embodiments) presented herein are not intended to limit the scope of the appended claims. The present invention has been fully described, and those skilled in the art will appreciate that many changes and modifications may be made thereto without departing from the concept or scope of the appended claims.

[0078] To illustrate the interchangeability and interchangeability of hardware and software, various illustrative blocks, modules, elements, methods, operations, instructions, algorithms, etc., have been described generally in terms of their functionality. Whether such functionality is implemented as hardware, software, or a combination of hardware and software depends on the particular application and design constraints imposed on the overall system. Skilled artisans may make or implement the described functionality in various ways for each particular application.

[0079] As used herein, a phrase such as "at least one of" preceding a list of items with the term "and" or "or" to distinguish between the items modifies the list as a whole, rather than modifying each member (e.g., each item) of the list. A phrase such as "at least one" does not necessarily require the selection of at least one item, but rather allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the terms "at least one of A, B, and C" or "at least one of A, B, or C" refer to A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0080] The term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "exemplary" is not necessarily to be construed as more preferred or advantageous than other aspects. Expressions such as an aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, an embodiment, the embodiment, another aspect, some aspects, one or more aspects, a configuration, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations thereof, and similar expressions and phrases are for convenience only and do not imply that the disclosure associated with such expressions and phrases is essential to the subject technology or that the disclosure applies to all configurations of the subject technology. The disclosure associated with such expressions and phrases may apply to all configurations or one or more configurations. The disclosure relating to such phrases may provide one or more examples. A phrase such as "summary" or "some summaries" may refer to one or more summaries, and vice versa, as well as other phrases described above.

[0081] Singular elements are intended to mean "one or more" rather than "one and only one" unless otherwise specifically stated. Masculine pronouns (e.g., "his") include feminine and neuter genders (e.g., "her and its") and vice versa. Terms such as "some" refer to one or more. Underlined and / or italicized titles and subheadings are used for convenience only and do not limit the subject art or are to be considered in connection with the interpretation of the subject art. Relative terms such as "first" and "second" may be used to distinguish one entity or action from another entity or action, but do not necessarily require or imply a physical relationship or order between such entities or actions. All structural or functional equivalents of the various elements described in this disclosure that are known or later become known to those of skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be made publicly available, regardless of whether such disclosure is expressly set forth in the description above. No claim element is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph (35 U.S.C.) unless the element is expressly recited using "means for" or defined in a method claim using "step for."

[0082] Although the present specification contains many specific details, these should not be construed as limitations on the scope defined by the claims, but rather as descriptions of certain particular implementations of the subject matter. Certain features described in the present specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple (or multiple) embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a certain combination and may be initially described as such, one or more features from a described combination may in some cases be removed from the combination, and a described combination may be (or may be directed to) a subcombination or a variation of the subcombination.

[0083] The title, background, brief description of the drawings, abstract, and drawings are incorporated in this disclosure and are provided as illustrative examples of the disclosure, not as limiting descriptions. It may be understood that such title, background, brief description of the drawings, abstract, and drawings are not used as limiting the scope and meaning of the claims. Furthermore, in the detailed description, the description may provide illustrative examples, and it may be understood that various features are grouped together in various implementations for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the described subject matter requires more features than are expressly recited in each claim. Rather, as conveyed by the claims, the subject matter of the invention exists in less than all features of a single disclosed configuration or operation. The subject matter of the claims is incorporated into the detailed description, although each claim is provided in its own right as separately described subject matter.

[0084] The claims are not intended to be limited to the subject matter described herein, but are intended to encompass all subject matter that is legally equivalent and that is consistent with the full scope of the claim terms. However, the claims are not intended to, and should not be construed to, include subject matter that does not comply with applicable patent law requirements. The disclosure of this specification may include the following aspects. (Aspect 1) A device, comprising: Impermeable back layer; an adhesive layer in contact with the backing layer; an alkali metal selected from a single alkali metal and an alloy of multiple alkali metals, the alkali metal being in contact with at least a portion of the adhesive layer and defining a treatment area; and Release liner in contact with adhesive layer and treated area A device comprising: (Aspect 2) 1. A heat delivery system comprising: an impermeable protective container; and Device removably disposed in an impermeable protective container and The device is a thermal delivery system comprising a backing layer, an adhesive layer, an alkali metal selected from a single alkali metal and an alloy of multiple alkali metals in contact with the adhesive layer and defining a treatment region, and a removable release liner in contact with the adhesive layer. (Aspect 3) A kit comprising: a heat delivery system comprising a device removably disposed in a water-impermeable protective container; Optionally, a wipe; and Means for disposing of the device and The kit, wherein the device comprises a backing layer, an adhesive layer, and an alkali metal selected from a single alkali metal and an alloy of multiple alkali metals, in contact with the adhesive layer and defining a treatment area. (Aspect 4) 1. A method for treating hyperhidrosis, comprising: providing a thermal delivery system comprising a device removably disposed in an impermeable protective container, the device comprising a backing layer, an adhesive layer, an alkali metal selected from an alkali metal and an alloy of alkali metals in contact with the adhesive layer and defining a treatment area, and a release liner in contact with the treatment area; Remove or provide instructions for removal of release liners; and Applying or instructing the device to the subject's skin, whereby the treatment area is brought into contact with the skin at the treatment site. Consisting of A method in which moisture on or at the skin reacts with an alkali metal to generate heat and reduce sweat production at the treatment site. (Aspect 5) The device, system, kit, or method of any one of embodiments 1 to 4, wherein the treatment area has a length and width or a diameter, and the backing layer has a length and width that are greater than the length and width of the treatment area, or has a diameter that is greater than the diameter of the treatment area. (Aspect 6) A device, system, kit or method according to any of aspects 1 to 5, wherein the release liner has a length and width greater than the length and width of the treatment area, or has a diameter greater than the diameter of the treatment area. (Aspect 7) The device, system, kit, or method of any one of aspects 1 to 6, wherein the release liner has a length and width greater than the length and width of the backing layer, or has a diameter greater than the diameter of the backing layer. (Aspect 8) The device, system, kit, or method of any of aspects 1-7, wherein the release liner has a length and width greater than the length and width of the adhesive layer, or has a diameter greater than the diameter of the adhesive layer. (Aspect 9) The device, system, kit or method of any of aspects 1-5, wherein the release liner and backing layer have substantially the same length and width or substantially the same diameter, and in both cases, the release liner and backing layer are larger than the length and width of the treatment area or larger than the diameter of the treatment area. (Aspect 10) 10. The device, system, kit, or method of any one of embodiments 1 to 9, wherein the release liner (i) is in contact with the adhesive layer and (ii) covers the treatment area. (Aspect 11) 11. The device, system, kit or method of any of the preceding aspects, wherein the release liner extends to or beyond the boundary of the adhesive layer and covers the treatment area. (Aspect 12) 12. The device, system, kit, or method of any one of embodiments 1-11, wherein the lift tab is formed by inserting material between an edge portion of the adhesive layer and the release liner. (Aspect 13) 13. The device, system, kit or method of embodiment 12, wherein the lift tab material has opposing sides, one of the opposing sides being coated with a material that is non-adherent to the adhesive layer. (Aspect 14) 14. The device, system, kit or method of embodiment 12 or 13, wherein the lift tab material has opposing sides, one of the opposing sides being coated with a material that is adhesive to the adhesive layer. (Aspect 15) 15. The device, system, kit or method according to any one of embodiments 1 to 14, wherein the back layer is transparent. (Aspect 16) 16. The device, system, kit or method of any one of embodiments 1-15, wherein the backing layer is a clear adhesive coated polyolefin. (Aspect 17) 17. The device, system, kit or method of embodiment 16, wherein the polyolefin of the backing layer is polyethylene and the adhesive is an acrylate adhesive. (Aspect 18) 17. The device, system, kit or method of embodiment 16 or 16, wherein the adhesive is a pressure sensitive adhesive. (Aspect 19) 19. The device, system, kit or method of any one of embodiments 1-18, wherein the release liner is a thermoplastic polyolefin or polyester material having opposing sides, one of the opposing sides being coated with a release coating material. (Aspect 20) 20. The device, system, kit or method of embodiment 19, wherein the polyolefin material is polyethylene or polypropylene. (Aspect 21) 20. The device, system, kit or method of embodiment 19, wherein the polyester material is polyethylene terephthalate. (Aspect 22) 22. The device, system, kit or method of any one of embodiments 19 to 21, wherein the release coating material comprises silicone. (Aspect 23) 23. The device, system, kit or method according to any of the preceding embodiments, wherein the alkali metal is selected from pure sodium and pure potassium. (Aspect 24) 24. The device, system, kit or method of any one of embodiments 1 to 23, wherein the alkali metal is an alloy of pure alkali metals selected from sodium and potassium. (Aspect 25) 25. The device, system, kit or method according to any of embodiments 1-24, wherein the alkali metals and alloys are not salts or oxides. (Aspect 26) 26. The device, system, kit, or method of any one of embodiments 1-25, wherein the alkali metal is a continuous layer. (Aspect 27) 26. The device, system, kit or method of any one of embodiments 1 to 25, wherein the alkali metal is a particle population. (Aspect 28) 28. The device, system, kit, or method of any one of embodiments 1-27, wherein the backing layer has opposing sides, one side of the backing layer is coated with an adhesive layer, and the adhesive layer is a pressure-sensitive adhesive layer. (Aspect 29) 29. The device, system, kit or method of embodiment 28, wherein the pressure sensitive adhesive layer is comprised of a hydrophobic adhesive. (Aspect 30) 30. The device, system, kit or method of embodiment 29, wherein the hydrophobic adhesive is formed from an acrylic acid monomer or an acrylate monomer. (Aspect 31) 31. The device, system, kit or method of embodiment 30, wherein the acrylate monomer is selected from the group consisting of methyl acrylate, methyl methacrylate, ethyl acrylate, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, and 2-chloroethyl vinyl ether. (Aspect 32) 32. The device, system, kit, or method of any one of embodiments 29 to 31, wherein the hydrophobic adhesive is a polyacrylate. (Aspect 33) 33. The device, system, kit, or method of any one of embodiments 28 to 32, wherein the alkali metal is attached to the pressure sensitive adhesive layer. (Aspect 34) 33. The device, system, kit, or method of any one of aspects 28 to 32, wherein the alkali metal is provided in an adhesive matrix in contact with the pressure-sensitive layer or embedded in the adhesive matrix. (Aspect 35) 35. The device, system, kit, or method of any one of embodiments 1-34, wherein the treated area has a geometric shape and the backing layer has a geometric shape, the geometric shape of the treated area being different from the geometric shape of the backing layer. (Aspect 36) 36. The device, system, kit or method according to any one of embodiments 1 to 35, wherein the treatment area has an ovoid shape and the back layer has a rectangular shape. (Aspect 37) 37. The device, system, kit, or method of any one of embodiments 1-36, wherein the treated region has an area and the backing layer has an area, the area of ​​the treated region being at least 10% smaller than the area of ​​the backing layer. (Aspect 38) A kit according to any one of aspects 3 and 5 to 37, wherein the means for disposing of the device is a disposal container having a cavity configured to receive the device and an opening configured to receive the device within the cavity, the opening being a closable opening or capable of being sealed; Disposal containers are (i) A solvent that dissolves alkali metals; (ii) Means for the discharge of hydrogen or a hydrogen scavenger; and (iii) A mechanism for receiving water from the water source or from an external source. The kit comprises one or more of: (Aspect 39) The kit of embodiment 38, wherein the solvent is miscible with water. (Aspect 40) The kit of embodiment 38 or 39, wherein the means for disposing of the device is a disposal container that receives the device, the container having elements that allow controllably exposing the alkali metal to a reactant for the alkali metal or a solubilizing agent for the alkali metal. (Aspect 41) The kit of embodiment 40, wherein the alkali metal reactant or solubilizing agent is a solvent selected from an alcohol and a glycol. (Aspect 42) 42. The kit of embodiment 41, wherein the alcohol is selected from ethanol, isopropanol, t-butanol, stearyl alcohol, and tris(trimethylsilyl)methanol. (Aspect 43) 43. The kit of claim 41 or 42, wherein the glycol is propylene glycol. (Aspect 44) 44. The kit according to any one of embodiments 3 and 5 to 43, wherein the kit comprises a substantially dry wipe. (Aspect 45) A kit according to any one of embodiments 3 and 5-44, further comprising a solvent or reagent for application to the treatment site before or after treatment with the thermal delivery system. (Aspect 46) The kit of embodiment 45, wherein the solvent or reagent is separate from the wipes in a container. (Aspect 47) The kit of embodiment 45, wherein the solvent or reagent is present on or in the wipe such that a pre-moistened wipe is provided. (Aspect 48) 48. The kit according to any one of embodiments 44 to 47, further comprising a second wipe. (Aspect 49) The kit of embodiment 48, further comprising a second solvent or a second reagent for application to the treated surface after treatment with the thermal delivery system. (Aspect 50) 50. The kit of embodiment 49, wherein the second solvent or second reagent is separate from the second wipe in a container. (Aspect 51) The kit according to embodiment 49, wherein the second solvent or second reagent is present on or in the second wipe, such that a pre-moistened second wipe is provided. (Aspect 52) 52. The kit according to any one of aspects 49 to 51, wherein the second solvent or the second reagent is a weak acid. (Aspect 53) 53. The kit of embodiment 52, wherein the weak acid is citric acid or acetic acid. (Aspect 54) The method of any of aspects 4-37, wherein applying or instructing for said application temporarily, non-permanently reduces sweat production at the treatment site for a period of at least about two weeks. (Aspect 55) 55. The method of embodiment 54, further comprising repeating at least one of said providing, said removing, and said applying. (Aspect 56) 56. The method of embodiment 55, wherein said repeating is performed monthly, every other month, or every three months. (Aspect 57) 57. The device, system, kit, or method of any one of the preceding embodiments, wherein the pure alkali or alloy is in the form of a foil having a thickness of about 0.0254 to 2.54 mm (0.001 inch to 0.10 inch). (Aspect 58) 58. The device, system, kit, or method of any one of embodiments 1 to 57, wherein the release liner is impermeable to oxygen, liquid water, and / or water vapor. (Aspect 59) 1. A method for treating a skin or mucosa treated surface, comprising: Identifying a treatment surface skin or treatment surface mucosa in a subject that requires treatment; providing a thermal delivery system comprising a device removably disposed in an impermeable protective container, the device comprising a backing layer, an adhesive layer, an alkali metal selected from an alkali metal and an alloy of alkali metals in contact with the adhesive layer and defining a treatment area, and a release liner in contact with the treatment area; Remove or provide instructions for removal of release liners; Optionally, subjecting the treated surface to wiping with a first wipe or providing instructions for wiping; applying or directing the device to the surface to be treated such that the treatment area contacts the surface to be treated and moisture on or at the surface to be treated reacts with the alkali metal to produce the amount of heat required for treatment; and Optionally, after applying or providing instructions for said application, wiping the treated surface with a second wipe; The method comprising: (Aspect 60) 1. A method for treating a skin or mucosal treated surface, comprising: Providing a kit as described herein Optionally, wiping or providing instructions for wiping the skin or mucous membrane treated surface with a first wipe provided in the kit; applying or instructing to apply the device to the surface to be treated such that the treatment area of ​​the device contacts the surface to be treated and moisture on or at the surface to be treated reacts with the alkali metal to generate the amount of heat required for treatment; and Optionally, after applying or providing instructions for said application, wiping the treated surface with or providing instructions for wiping with a second wipe provided in the kit. The method comprising: (Aspect 61) The method of embodiment 59 or 60, wherein the first wipe and the second wipe, if both are present, are the same as each other. (Aspect 62) The method of embodiment 59 or 60, wherein the first wipe and the second wipe, if both are present, are different from each other. (Aspect 63) 63. The method of any of embodiments 59-62, wherein the second wipe is moistened with or comprises a reagent or solvent. (Aspect 64) 64. The method of any one of embodiments 59-63, wherein the first wipe is substantially dry. (Aspect 65) A method according to any of embodiments 59 to 64, wherein the solvent or reagent is provided in the kit or is provided on the first wipe. (Aspect 66) 66. The method of embodiment 65, wherein the solvent or reagent for the first wipe is substantially non-aqueous. (Aspect 67) 67. The method of any of embodiments 59-66, wherein the solvent or reagent is provided in the kit or on the second wipe. (Aspect 68) 68. The method of embodiment 67, wherein the solvent or reagent is a weak acid. (Aspect 69) The method of embodiment 68, wherein the weak acid is citric acid or acetic acid.

Claims

1. A device, comprising: an impermeable back layer; an adhesive layer in contact with the backing layer; an alkali metal selected from a single alkali metal and an alloy of multiple alkali metals, the alkali metal being in contact with at least a portion of the adhesive layer and defining a treatment area; and A release liner in contact with the adhesive layer and the treated area. A device comprising:

2. 1. A heat delivery system comprising: an impermeable protective container; and Device removably disposed in an impermeable protective container and A thermal delivery system, the device comprising a backing layer, an adhesive layer, an alkali metal selected from a single alkali metal and an alloy of multiple alkali metals, in contact with the adhesive layer and defining a treatment area, and a removable release liner in contact with the adhesive layer.

3. A kit comprising: a heat delivery system comprising a device removably disposed in a water-impermeable protective container; Optional wipes; and Means for disposing of the device and The kit, wherein the device comprises a backing layer, an adhesive layer, and an alkali metal selected from a single alkali metal and an alloy of multiple alkali metals, in contact with the adhesive layer and defining a treatment area.

4. 1. A method for treating hyperhidrosis, comprising: providing a thermal delivery system comprising a device removably disposed in an impermeable protective container, the device comprising a backing layer, an adhesive layer, an alkali metal selected from an alkali metal and an alloy of alkali metals in contact with the adhesive layer and defining a treatment area, and a release liner in contact with the treatment area; Remove or provide instructions for removal of the release liner; and Applying or instructing the device to the subject's skin, whereby the treatment area is brought into contact with the skin at the treatment site. Consisting of A method in which moisture on or at the skin reacts with an alkali metal to generate heat and reduce sweat production at the treatment site.

5. The device, system, kit or method of any one of claims 1 to 4, wherein the treatment area has a length and width or a diameter, and the backing layer has a length and width greater than the length and width of the treatment area, or has a diameter greater than the diameter of the treatment area.

6. The device, system, kit or method of any of claims 1 to 5, wherein the release liner has a length and width greater than the length and width of the treatment area, or has a diameter greater than the diameter of the treatment area.

7. The device, system, kit or method of any of claims 1 to 6, wherein the release liner has a length and width greater than the length and width of the backing layer, or has a diameter greater than the diameter of the backing layer.

8. The device, system, kit or method of any of claims 1 to 7, wherein the release liner has a length and width greater than the length and width of the adhesive layer, or has a diameter greater than the diameter of the adhesive layer.

9. The device, system, kit or method of any of claims 1 to 5, wherein the release liner and backing layer have substantially the same length and width or substantially the same diameter, and in both cases the release liner and backing layer are larger than the length and width of the treatment area or larger than the diameter of the treatment area.

10. The device, system, kit or method of any of claims 1 to 9, wherein the release liner (i) is in contact with the adhesive layer and (ii) covers the treatment area.

11. The device, system, kit or method of any of claims 1 to 10, wherein the release liner extends up to or beyond the boundary of the adhesive layer and covers the treated area.

12. The device, system, kit or method of any preceding claim, wherein the lift tab is formed by inserting material between an edge portion of the adhesive layer and the release liner.

13. 13. The device, system, kit or method of claim 12, wherein the lift tab material has opposing sides, one of the opposing sides being coated with a material that exhibits non-adherence to the adhesive layer.

14. 14. The device, system, kit or method of claim 12 or 13, wherein the lift tab material has opposing sides, one of the opposing sides being coated with a material that is adhesive to the adhesive layer.

15. The device, system, kit or method according to any one of claims 1 to 14, wherein the back layer is transparent.

16. The device, system, kit or method of any preceding claim, wherein the backing layer is a clear adhesive coated polyolefin.

17. 17. The device, system, kit or method of claim 16, wherein the polyolefin of the backing layer is a polyethylene and the adhesive is an acrylate adhesive.

18. 17. The device, system, kit or method of claim 16 or 16, wherein the adhesive is a pressure sensitive adhesive.

19. 19. The device, system, kit or method of any of claims 1 to 18, wherein the release liner is a thermoplastic polyolefin or polyester material having opposing sides, one of the opposing sides being coated with a release coating material.

20. 20. The device, system, kit or method of claim 19, wherein the polyolefin material is polyethylene or polypropylene.

21. 20. The device, system, kit or method of claim 19, wherein the polyester material is polyethylene terephthalate.

22. The device, system, kit or method of any of claims 19 to 21, wherein the release coating material comprises silicone.

23. 23. The device, system, kit or method of any preceding claim, wherein the alkali metal is selected from pure sodium and pure potassium.

24. 24. The device, system, kit or method of any preceding claim, wherein the alkali metal is an alloy of pure alkali metals selected from sodium and potassium.

25. The device, system, kit or method of any preceding claim, wherein the alkali metals and alloys are not salts or oxides.

26. The device, system, kit or method of any preceding claim, wherein the alkali metal is a continuous layer.

27. The device, system, kit or method of any preceding claim, wherein the alkali metal is in a particle population.

28. 28. The device, system, kit or method of any of claims 1 to 27, wherein the backing layer has opposing sides, one side of the backing layer is coated with an adhesive layer, the adhesive layer being a pressure sensitive adhesive layer.

29. 30. The device, system, kit or method of claim 28, wherein the pressure sensitive adhesive layer is comprised of a hydrophobic adhesive.

30. 30. The device, system, kit or method of claim 29, wherein the hydrophobic adhesive is formed from an acrylic acid monomer or an acrylate monomer.

31. 31. The device, system, kit or method of claim 30, wherein the acrylate monomer is selected from the group consisting of methyl acrylate, methyl methacrylate, ethyl acrylate, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, and 2-chloroethyl vinyl ether.

32. The device, system, kit or method of any one of claims 29 to 31, wherein the hydrophobic adhesive is a polyacrylate.

33. The device, system, kit or method of any of claims 28 to 32, wherein the alkali metal is attached to the pressure sensitive adhesive layer.

34. The device, system, kit or method of any of claims 28 to 32, wherein the alkali metal is provided in or embedded in an adhesive matrix in contact with the pressure sensitive layer.

35. 35. The device, system, kit or method of any of claims 1 to 34, wherein the treated areas have a geometric shape and the backing layer has a geometric shape, the geometry of the treated areas being different from the geometry of the backing layer.

36. The device, system, kit or method of any of claims 1 to 35, wherein the treatment area has an ovoid shape and the backing layer has a rectangular shape.

37. 37. The device, system, kit or method of any preceding claim, wherein the treated region has an area and the backing layer has an area, the area of ​​the treated region being at least 10% smaller than the area of ​​the backing layer.

38. A kit according to any one of claims 3 and 5 to 37, wherein the means for disposing of the device is a disposal container having a cavity configured to receive the device and an opening configured to receive the device in the cavity, the opening being a closable opening or capable of being sealed; Disposal containers are (i) a solvent that dissolves the alkali metal; (ii) a means for the discharge of hydrogen or a hydrogen scavenger; and (iii) A mechanism for receiving water from the water source or an external water source. The kit comprises one or more of:

39. 39. The kit of claim 38, wherein the solvent is miscible with water.

40. 40. The kit of claim 38 or 39, wherein the means for disposing of the device is a disposal container that receives the device, the container having elements that allow controllably exposing the alkali metal to a reactant for the alkali metal or a solubilizer for the alkali metal.

41. 41. The kit of claim 40, wherein the alkali metal reactant or solubilizing agent is a solvent selected from an alcohol and a glycol.

42. 42. The kit of claim 41, wherein the alcohol is selected from ethanol, isopropanol, t-butanol, stearyl alcohol, and tris(trimethylsilyl)methanol.

43. 43. The kit of claim 41 or 42, wherein the glycol is propylene glycol.

44. The kit of any one of claims 3 and 5 to 43, wherein the kit comprises a substantially dry wipe.

45. The kit of any of claims 3 and 5-44, wherein the kit further comprises a solvent or reagent for application to the treatment site before or after treatment with the thermal delivery system.

46. 46. ​​The kit of claim 45, wherein the solvent or reagent is separate from the wipes in a container.

47. 46. ​​The kit of claim 45, wherein the solvent or reagent is present on or in the wipe such that a pre-moistened wipe is provided.

48. The kit of any one of claims 44 to 47, wherein the kit comprises a second wipe.

49. 49. The kit of claim 48, further comprising a second solvent or a second reagent for application to the treated surface after treatment with the thermal delivery system.

50. 50. The kit of claim 49, wherein the second solvent or second reagent is separate from the second wipe in a container.

51. 50. The kit of claim 49, wherein the second solvent or second reagent is present on or in the second wipe such that a pre-moistened second wipe is provided.

52. 52. The kit of any one of claims 49 to 51, wherein the second solvent or the second reagent is a weak acid.

53. 53. The kit of claim 52, wherein the weak acid is citric acid or acetic acid.

54. 38. The method of any of claims 4-37, wherein applying or instructing for said application temporarily, non-permanently reduces sweat production at the treatment site for a period of at least about two weeks.

55. 55. The method of claim 54, further comprising repeating at least one of said providing, said removing, and said applying.

56. 56. The method of claim 55, wherein said repeating occurs monthly, every other month, or every three months.

57. 57. The device, system, kit or method of any preceding claim, wherein the pure alkali or alloy is in the form of a foil having a thickness of about 0.0254-2.54 mm (0.001 inch to 0.10 inch).

58. 58. The device, system, kit or method of any preceding claim, wherein the release liner is impermeable to oxygen, liquid water and / or water vapor.

59. 1. A method for treating a skin or mucosal treated surface, comprising: Identifying a treatment surface skin or treatment surface mucosa in a subject that requires treatment; providing a thermal delivery system comprising a device removably disposed in an impermeable protective container, the device comprising a backing layer, an adhesive layer, an alkali metal selected from an alkali metal and an alloy of alkali metals in contact with the adhesive layer and defining a treatment area, and a release liner in contact with the treatment area; Remove or provide instructions for removal of release liners; Optionally, subjecting the treated surface to wiping with a first wipe or providing instructions for wiping; applying or instructing the device to the surface to be treated such that the treatment area contacts the surface to be treated and moisture on or at the surface to be treated reacts with the alkali metal to generate the amount of heat required for treatment; and Optionally, after applying or providing instructions for said application, wiping the treated surface with a second wipe; The method comprising:

60. 1. A method for treating a skin or mucosal treated surface, comprising: Providing a kit as described herein Optionally, wiping or providing instructions for wiping the skin or mucous membrane treated surface with a first wipe provided in the kit; applying or instructing to apply the device to the surface to be treated such that the treatment area of ​​the device contacts the surface to be treated and moisture on or at the surface to be treated reacts with the alkali metal to generate the amount of heat required for treatment; and Optionally, after applying or providing instructions for said application, wiping the treated surface with or providing instructions for wiping with a second wipe provided in the kit. The method comprising:

61. 61. The method of claim 59 or 60, wherein the first wipe and the second wipe, if both are present, are the same as each other.

62. 61. The method of claim 59 or 60, wherein the first wipe and the second wipe, if both are present, are different from each other.

63. A method according to any of claims 59 to 62, wherein the second wipe is moistened with or comprises a reagent or solvent.

64. The method of any of claims 59 to 63, wherein the first wipe is substantially dry.

65. The method of any of claims 59 to 64, wherein the solvent or reagent is provided in the kit or is provided on the first wipe.

66. 66. The method of claim 65, wherein the solvent or reagent for the first wipe is substantially non-aqueous.

67. The method of any of claims 59 to 66, wherein the solvent or reagent is provided in the kit or on the second wipe.

68. 68. The method of claim 67, wherein the solvent or reagent is a weak acid.

69. 69. The method of claim 68, wherein the weak acid is citric acid or acetic acid.

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