WO2023022962A1

WO2023022962A1 - Skin patch having a controlled atmosphere

Info

Publication number: WO2023022962A1
Application number: PCT/US2022/040294
Authority: WO
Inventors: Todd Cartner
Original assignee: Gojo Industries, Inc.
Priority date: 2021-08-20
Filing date: 2022-08-15
Publication date: 2023-02-23

Abstract

A skin patch includes a housing having a hollow portion that defines a cavity and a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity. The housing and the membrane define the upper cavity. The skin patch also includes a material disposed in the upper cavity. The material may be a hygroscopic material, a moisture emitting material, or a medication material. The membrane and the skin of the user at least partially define the lower cavity, and the lower cavity can include an air gap.

Description

SKIN PATCH HAVING A CONTROLLED ATMOSPHERE

TECHNICAL FIELD

[0001] The present invention relates generally to a skin patch, and, more particularly, to a skin patch for use in testing the skin of a user.

BACKGROUND

[0002] Some prior art skin patches are patches designed to be removably attached to a user’s skin for testing purposes or as a drug delivery device. For example, skin patches have been used for predictive testing or diagnostic testing. Skin patches typically include a material (e.g., an absorbent material) that contacts the user’s skin.

[0003] One type of test is a Forearm Controlled Application Test (FCAT), which is a skin study where skin is measured and treated in a clinical lab over multiple days. In some instances, the skin study could last between 1 and 2 weeks. The participants in the study enter the lab for the study and then go home at the end of the day, which causes the participants to be subjected to various environments.

[0004] Another type of test is a “wash out” test, which is a clinical process that creates a desired skin condition prior to a clinical study regardless of the type of skin condition that is common to the local population where the study is completed. The desired skin condition is typically achieved by treating the skin in some manner (e.g., with harsh soap to dry out the skin) for a period of time (e.g., a week or more) prior to the study. The purpose of the “wash out” test is to create a skin condition that mimics the skin condition of a target demographic such that a product intended for the target demographic can be studied.

SUMMARY

[0005] An exemplary skin patch for attaching to skin of a user includes a housing having a hollow portion that defines a cavity, a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity. The housing and the membrane define an upper cavity. An environment altering material is located in the upper cavity. An adhesive is included for attaching the skin patch to the skin of the user. A lower cavity formed below the membrane, wherein the lower cavity includes an air gap between the membrane and the bottom of the housing.

[0006] Another exemplary skin patch for attaching to skin of a user includes a housing having a hollow portion that defines a cavity and a bottom portion. An environment altering material is disposed in the cavity. An air gap is located between the environment altering material and the bottom of the housing.

[0007] Another exemplary skin patch for attaching to skin of a user includes a membrane attached to the shell such that the cavity is separated into an upper cavity and a lower cavity, wherein the shell and the membrane define the upper cavity. A hygroscopic material is disposed in the upper cavity. An adhesive is included for attaching the skin patch to the skin of the user. An air gap is located the lower cavity below the membrane.

[0008] Another exemplary skin patch for attaching to skin of a user includes a silicone shell that defines a cavity, a membrane attached to the shell such that the cavity is separated into an upper cavity and a lower cavity, a moisture emitting material disposed in the upper cavity. An adhesive for attaching the skin patch to the skin of the user is included. The lower cavity includes an air gap below the membrane.

[0009] Another exemplary skin patch for attaching to skin of a user includes a silicone shell that defines a cavity and a membrane attached to the shell such that the cavity is separated into an upper cavity and a lower cavity. A medication material disposed in the upper cavity. The skin patch further includes an adhesive for attaching the skin patch to the skin of the user such that the membrane and the skin of the user, and the lower cavity includes an air gap below the membrane.

[0010] Another exemplary skin patch for attaching to skin of a user includes a housing having a hollow portion that defines a cavity, a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity. The lower cavity includes an air gap and a hygroscopic material disposed in the upper cavity.

[0011] Another exemplary skin patch for attaching to the skin of a user, includes a housing having a hollow portion that defines a cavity, a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity. The lower cavity includes an air gap and a moisture emitting material disposed in the upper cavity.

[0012] Another exemplary skin patch for attaching to skin of a user includes a housing having a hollow portion that defines a cavity, a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity. The lower cavity includes an air gap and a medication material disposed in the upper cavity.

[0013] Some skin patches include a housing having a hollow portion that defines a cavity and a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity. The housing and the membrane define the upper cavity. The skin patch also includes a material disposed in the upper cavity. The material may be a hygroscopic material, a moisture emitting material, or a medication material. The skin patch further includes an adhesive for attaching the skin patch to the skin of the user. A lower cavity is formed below the membrane and above the skin of the user, creating an air gap between the membrane and the skin.

[0014] Some skin patches include a housing having a hollow portion that defines a cavity. The skin patch also includes a material disposed in the cavity such that a gap exists between the material and the skin of a user when the skin patch is attached to the user. The material may be a hygroscopic material, a moisture emitting material, or a medication material.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is a schematic view of an exemplary embodiment of a skin patch;

[0016] FIG. 2 is cross-sectional view of another exemplary embodiment of a skin patch;

[0017] FIG. 3 is an exploded cross-sectional view of the skin patch of FIG. 2;

[0018] FIG. 4 is a cross-sectional view of another exemplary embodiment of a skin patch;

[0019] FIG. 5 is an exploded cross-sectional view of the skin patch of FIG. 4;

[0020] FIG. 6 is cross-sectional view of another exemplary embodiment of a skin patch;

[0021] FIG. 7 is an exploded cross-sectional view of the skin patch of FIG. 6; and [0022] FIG. 8 is a schematic view of another exemplary embodiment of a skin patch.

DETAILED DESCRIPTION

[0023] The Detailed Description describes exemplary embodiments of the invention and is not intended to limit the scope of the claims in any way. Indeed, the invention is broader than and unlimited by the exemplary embodiments, and the terms used in the claims have their full ordinary meaning. Features and components of one exemplary embodiment may be incorporated into the other exemplary embodiments. Inventions within the scope of this application may include additional features, or may have less features, than those shown in the exemplary embodiments.

[0024] Skin patches described herein may be configured to create a controlled environment such that skin testing can be conducted without environmental influences that may adversely affect the test results. For example, with regards to an FCAT study, skin patches described herein are configured to reduce or eliminate the influence of the outside environment (e.g., the outside environment that surrounds the participants when they leave the clinical lab at the end of the day) by maintaining an environment within the skin patch that corresponds to the environment of the lab, or other desired environment. With regards to the “wash out” test, skin patches described herein are configured to maintain a desired skin condition for a clinical study regardless of the environment in which the study is being performed.

[0025] Skin patches described herein include a housing having a hollow portion and a bottom portion. Some skin patches, the bottom portion is an attachment portion, in which the hollow portion defines a cavity that is separated into an upper cavity and a lower cavity by a membrane. A material used for creating the controlled environment and/or drug delivery is located in the upper cavity of the housing, and the membrane prevents the material from directly contacting the user’s skin. The housing may be non-breathable to create a controlled environment in the cavity. A non-breathable housing prevents the moisture in the exterior environment from affecting the material in the upper cavity, as well as maintains an air gap in the lower cavity that is not affected by the moisture in the exterior environment. In some embodiments, however, the housing may be partially breathable by being configured to allow moisture to leave the housing, but prevent moisture from entering the housing, or vice versa. The membrane may breathable and/or porous such that moisture or medication can move between the upper cavity and the lower cavity through the membrane. In some embodiments, the membrane provides a controlled release of medication from the upper cavity to the lower cavity. For a two cavity patch, the term upper refers to the cavity that is furthest away from the skin, when the patch is adhered to the skin. The term lower, refers to the cavity closest to the skin when the patch is adhered to the skin. The term upper cavity may be referred to as the outer cavity and the term lower cavity may be referred to as the inner cavity. In some embodiments, the membrane may be partially breathable and be configured to allow moisture to move from the lower cavity to the upper cavity, but also to prevent moisture from moving from the upper cavity to the lower cavity, or vice versa.

[0026] In various embodiments, moisture can be removed from the air gap of the lower cavity by placing a hygroscopic material in the upper cavity. Such a patch may be used to perform “dry out” test of the user’s skin. In some configurations, rather than drying out the skin, the hygroscopic material can be selected to maintain a desired moisture level in the air gap. In some embodiments, moisture can be emitted from a moisture emitting material located in the upper cavity to the air gap in the lower cavity. Such a configuration may be used to perform a “hydration” test of the skin, or be used to maintain a desired moisture level in the air gap. In some configurations, a medication emitting material in the upper cavity can be used to emit medication through the membrane and into the lower cavity. Such a configuration may be used to provide medication to a user, through a transdermal process.

[0027] FIG. 1 illustrates an exemplary embodiment of a skin patch 100 attached to the skin 101 of a user. The skin patch 100 includes a housing 102, a membrane 104, an environment altering material, such as, for example, a hygroscopic material 106, and an optional adhesive 108. The housing 102 includes an inner surface 110 that defines a cavity 112. In certain embodiments, the housing includes a hollow portion 122 and an attachment portion 124. Attachment portion is preferably located at a bottom of the housing. The hollow portion 122 defines the cavity 112, and the attachment portion 124 is configured to secure the skin patch 100 to the skin 101 of a user.

[0028] The hollow portion 122 of the housing may take any suitable shape, such as, for example, a rounded-dome shape, a polygonal dome shape, a spherical shape, a rectangular prism shape, or any other shape that is capable of defining the cavity 112. The attachment portion 124 may take any suitable form that is capable of securing the skin patch 100 to the user’s skin 101 such that the cavity 112 creates a controlled environment adjacent to the user’s skin. For example, in certain embodiments, the attachment portion 124 may be an annular projection that extends from the hollow portion 122, a rectangular projection that extends from the hollow portion, a flange that extends from the hollow portion 122, a bottom surface of the hollow portion 122, any skin contact member that is attached to the hollow portion or integral with the hollow portion, or any other type of member or surface that is capable of attaching the skin patch 100 to a user’s skin 101 to create a controlled environment. Optionally, the attachment portion 124 completely surrounds the hollow portion 122. Optionally, the attachment portion 124 partially surrounds the hollow portion 122.

[0029] The housing 102 may be non-breathable such that moisture cannot enter the cavity 112 from an exterior of the housing 102 or exit the cavity 112 to an exterior of the housing 102. In some embodiments, the housing 102 is permeable. In some embodiments, the housing 102 is one-way permeable. In some embodiments, the housing 102 may be configured to be one way permeable such that moisture can leave the housing 102, but cannot enter the housing 102, or vice versa. The housing 102 can be made of, for example, silicone, rubber, elastomeric materials, materials that include silicone, any suitable flexible material, or any other type of suitable material. The housing 102 may be a flexible material or a rigid material. In certain embodiments, the housing 102 may include a silicone shell that defines the cavity 112.

[0030] A membrane 104 can be attached to the housing 102 such that the cavity 112 is separated into an upper cavity 114 and an lower cavity 116. The membrane 104 may be attached to one or both of the interior surface 110 of the housing 102 and the attachment portion 124 of the housing 102. For example, the membrane 104 can be attached to the interior surface 110 of the housing 102 by an adhesive, a friction-fit connection, a snap-fit connection, or any other suitable type of fastener that separates the cavity 112 into an upper cavity 114 and a lower cavity 116. In another example, the membrane 104 can be attached to the attachment portion 124 of the housing 102 by an adhesive or any other suitable type of fastener that separates the cavity 112 into an upper cavity 114 and a lower cavity 116.

[0031] In certain embodiments, the upper cavity 114 is defined by an inner surface 110 of the housing 102 and the membrane 104. The lower cavity 116 may be defined at least in part by the membrane 104 and the lower portion of housing 102. The skin 101 of a user (when the skin patch 100 is attached to a user) may further define the lower cavity 116. In some embodiments, the lower cavity 116 is defined by the housing 102, the membrane 104, and the bottom of the housing 102. The lower cavity 114 is an open area below the membrane 104 that includes an air gap 118.

[0032] The membrane 104 may be made of a breathable material or permeable material that allows moisture to travel between the upper cavity 114 and the lower cavity 116. In some embodiments, the membrane may be configured to allow moisture to travel from the lower cavity 116 to the upper cavity 114, but not allow moisture to travel from the upper cavity 116 to the lower cavity 114, or vice versa. The membrane 104 can be made of, for example, PTFE, ePTFE, HDPE, or any other type of suitable material. In certain embodiments, the membrane 104 can include a desiccant material. The membrane 104 may be a flexible material or a rigid material.

[0033] The upper cavity 114 is sized for housing the hygroscopic material 106. In certain embodiments, the upper cavity 114 can have a volume of between about 50 mm³ and about 75 cm³. The lower cavity 116 includes an air gap 118 between the skin 101 of a user (when the skin patch 100 is attached to a user) and the membrane 104. In certain embodiments, the lower cavity 116 forms an open area that can have a volume of between about 50 mm³ and about 25 cm³. In various embodiments, the volume of the upper cavity 114 can be substantially equal to the volume of the lower cavity 116. In other embodiments, a ratio of the volume of the upper cavity 114 to the volume of the lower cavity 116 can be greater than 1 to 1, such as greater than or equal to 2 to 1, such as greater than or equal to 3 to 1, such as greater than or equal to 4 to 1, such as greater than or equal to 5 to 1. The hygroscopic material 106 is positioned in the upper cavity 114 such that the hygroscopic material can absorb moisture from air gap 118 of the lower cavity 116 through the membrane 104. The hygroscopic material 106 can be, for example, desiccant, silica gel, or any other type of suitable material.

[0034] The optional adhesive 108 is configured to attach the skin patch 100 to a user such that the cavity 112 is sealed from the outside environment to create a controlled environment within the cavity 112. The adhesive 108 can be attached to one or both of the housing 102 or the membrane 104. The skin patch 100 may include an optional release paper (e.g., release paper 220 shown in FIGS. 2-3) that is removably attached to the skin patch 100 to protect the adhesive 108 prior to use of the skin patch. In embodiments that do not include the adhesive 108, a large piece of flexible tape or a bandage may be placed over the skin patch 100 and extend beyond the edges of the skin patch such that the extended pieces of the flexible tape or bandage can be used engage the user’s skin to attach the skin patch to the user.

[0035] The skin patch 100 is attached to the skin 101 of a user such that the air gap 118 is positioned in the lower cavity 116 adjacent to the skin 101 and the membrane 104. The membrane 104 prevents the hygroscopic material 106 from contacting the skin 101. The connection between the optional adhesive 108 and the skin 101 may create a controlled environment within the cavity 112, and the hygroscopic material 106 absorbs moisture from the lower cavity 116 through the breathable membrane 104.

[0036] The controlled environment within the cavity 112 allows the skin patch 100 to be used to test an area of skin under the skin patch 100 of a user without exterior environmental influences adversely affecting the test results. That is, the hygroscopic material 106 can be used during a “dry out” test of the skin, or to maintain a desired moisture level of the skin, and the controlled environment prevents weather conditions from affecting the hygroscopic material. In addition, the air gap 118 created by the positioning of the membrane 104 relative to the housing 102 provides a controlled environment from which the hygroscopic material 106 can absorb moisture to dry the air adjacent to the user’s skin 101. The amount of hygroscopic material 106 may be varied to obtain desired “dryness.” Desired dryness may be, for example, less than 50% humidity, such as less than 40% humidity, such as less than 30% humidity, such as less than 20% humidity; such as less than 10% humidity. The amount of hygroscopic material 106 required to achieve a desired humidity may depend on factors such as, for example, the size of the lower cavity 116, the effectiveness of the material 106, the type of material 106, the objective of the testing, as well as various other potential factors.

[0037] In some embodiments, the environment altering material, described as a hygroscopic material 106 above, is a moisture emitting material, rather than the hygroscopic material. In these embodiments, the moisture emitting material is configured to provide moisture to the air in cavity 116 such that the moist, humid air contacts the skin 101 of the user. The moisture emitting material (not shown) can be, for example, a humidity control packet (e.g., a packet made by Boveda, Inc.), a propylene glycol solution (e.g., a propylene glycol packet), or any other suitable type of moisture emitting material. [0038] In these embodiments, the controlled environment within the cavity 112 allows the skin patch 100 may be used to perform a “hydration” test on a user that is located in any location and with any weather conditions. That is, the moisture emitting material (not shown) can be used during a “hydration” test of the skin, or to maintain a desired moisture level of the skin, and the controlled environment prevents weather conditions from affecting the moisture emitting material. In addition, the air gap 118 created by the positioning of the membrane 104 relative to the housing 102 provides a controlled environment from which the moisture emitting material can emit moisture to the air adjacent to the user’s skin 101.

[0039] In some embodiments, the environment altering material, described as a hygroscopic material above, is a medication material (not shown) which may be used, either in combination with one of the hygroscopic material or the moisture emitting material or by itself. The medication material is configured to emit a medication through membrane 104 and the skin 101 of the user to provide medication to the user through a transdermal process. The medication material can be, for example, a gas-emitting material, such as, for example, any material capable of emitting nitrous oxide and other medicinal gases used for sedation or other medical purposes, any material capable of emitting inhalation antiasthmatics, any material capable of emitting prescription nasal sprays or similar products, or any other suitable gas-emitting material.

[0040] Referring to FIGS. 2-3, another embodiment of a skin patch 200 (which is a more specific embodiment of the skin patch 100 shown in FIG. 1) includes a housing 202, a membrane 204, an environment altering material, such as, for example, a hygroscopic material 206, an optional adhesive 208, and an optional release paper 220. The housing 202 includes a hollow portion 222 and an attachment portion 224. The hollow portion 222 and the attachment portion 224 can take any suitable form, such as, for example, any form described in the present application. In certain embodiments, the housing 202 may include a shell that defines a cavity 212. The housing 202 can be made of, for example, silicone, rubber, elastomeric materials, materials that include silicone, any suitable flexible material, or any other type of suitable material.

[0041] In certain embodiments, an inner surface 310 of the hollow portion 222 of the housing 202 defines the cavity 212. The membrane 204 includes a barrier portion 226 and an attachment portion 228. The attachment portion 228 of the membrane 204 is attached to the attachment portion 224 of the housing 202 such that the barrier portion 226 of the membrane 204 is positioned within the hollow portion 222 of the housing 202 to separate the cavity 212 into an upper cavity 214 and a lower cavity 216. The attachment portion 228 can take any suitable form that is capable of attaching to at least one of the housing 202 and the user’s skin. In the illustrated embodiment, the attachment portion 228 is an annular projection that extends from the barrier portion 226. The attachment portion 228 can take any suitable form, however, such as any form described in the present application for the attachment portion of the housing. The housing 202 can be attached to the membrane 204 by any suitable means, such as, for example, an adhesive, a friction-fit connection, or any other suitable type of connection. In certain embodiments, such as the illustrated embodiment, the edge 230 of the housing 202 is aligned with the edge 232 of the membrane 204.

[0042] In some embodiments, the upper cavity 214 can have a volume of between about 50 mm³ and about 75 cm³. In some embodiments, the lower cavity 216 forms an open area that has a volume between about 50 mm³ and about 25 cm³. In various embodiments, the volume of the upper cavity 214 can be substantially equal to the volume of the lower cavity 216. In other embodiments, a ratio of the volume of the upper cavity 214 to the volume of the lower cavity 216 can be greater than 1 to 1, such as greater than or equal to 2 to 1, such as greater than or equal to 3 to 1, such as greater than or equal to 4 to 1, such as greater than or equal to 5 to 1.

[0043] The hygroscopic material 206 is disposed in the upper cavity 214 between the inner surface 310 of the hollow portion 222 of the housing 202 and the membrane 204. In certain embodiments, the housing 202 is made of a non-breathable material to prevent moisture from outside of the cavity 212 from being absorbed by the hygroscopic material 206. In other embodiments, however, the housing 202 may be configured to allow moisture to leave the housing 102, but not allow moisture to enter the housing from an exterior environment, or vice versa. The membrane 204 is made of a breathable material such that moisture from an air gap 218 of the lower cavity 214 can be absorbed by the hygroscopic material 206 through the membrane 204. The membrane 204 may allow moisture to move between both the upper cavity 214 and the lower cavity 216, or the membrane 204 may allow moisture to move from the lower cavity 214 to the upper cavity 216, but not allow moisture to move from the upper cavity 216 to the lower cavity. The hygroscopic material 206 is used to perform a “dry out” test on a user, or to maintain a desired moisture level of the user’s skin. [0044] In some embodiments, the environment altering material, described as a hygroscopic material 206 above, is replaced with a moisture emitting material (not shown), rather than the hygroscopic material 206. The moisture emitting material can be used to perform a “hydration” test on a user, or to maintain a desired moisture level of the user’s skin. The moisture emitting material can take any suitable form, such as, for example, the form of any moisture emitting material described in the present application. In some embodiments, the environment altering material, described as a hygroscopic material 206 above is replaced with a medication material, either in combination with one of the hygroscopic material or the moisture emitting material or by itself. The medication material is configured to emit a medication through the membrane 204 and the skin of a user to provide medication to the user through a transdermal process. The medication material can take any suitable form, such as, for example, the form of any medication material described in the present application.

[0045] The optional adhesive 208 is attached to a bottom surface of the attachment portion 228 of the membrane 204, and a release paper 220 is attached to the bottom surface of the membrane 204 to protect the adhesive 208 prior to use of the skin patch 200. The release paper 220 is removed prior to use of the skin patch 200. The optional release paper 220 may be aligned with the edges 230, 232, of the housing 202 and/or the membrane 204, or the release paper may extend past the edges 230, 232 of the housing 202 and/or the membrane 204. In embodiments that do not include the adhesive 208, a large piece of flexible tape or a bandage may be placed over the skin patch 200 and extend beyond the edges of the skin patch such that the extended pieces of the flexible tape or bandage can be used engage the user’s skin to attach the skin patch to the user.

[0046] Referring to FIGS. 4-5, another embodiment of a skin patch 400 (which is a more specific embodiment of the skin patch 100 shown in FIG. 1) includes a housing 402, a membrane 404, an environment altering material, such as, for example, a hygroscopic material 406, an optional adhesive 408, and an optional release paper 420. The housing 402 includes a hollow portion 422 and an attachment portion 424. The hollow portion 422 and the attachment portion 424 can take any suitable form, such as, for example, any form described in the present application. In certain embodiments, the housing 402 may include a shell that defines a cavity 412. The housing 402 can be made of, for example, silicone, rubber, elastomeric materials, materials that include silicone, any suitable flexible material, or any other type of suitable material. [0047] In certain embodiments, an inner surface 510 of the hollow portion 422 of the housing 402 defines the cavity 412. The membrane 404 includes a barrier portion 426 and an attachment portion 428. The attachment portion 428 of the membrane 404 is attached to the attachment portion 424 of the housing 402 such that the barrier portion 426 of the membrane 404 is positioned within the hollow portion 422 of the housing 402 to separate the cavity 412 into an upper cavity 414 and a lower cavity 416. The attachment portion 428 can take any suitable form that is capable of attaching to at least one of the housing 402 and the user’s skin. In the illustrated embodiment, the attachment portion 428 is an annular projection that extends from the barrio portion 226. The attachment portion 428 can take any suitable form, however, such as any form described in the present application for the attachment portion of the housing. The housing 402 can be attached to the membrane 404 by any suitable means, such as, for example, an adhesive, a friction-fit connection, or any other suitable type of connection. In certain embodiments, such as the illustrated embodiment, the edge 430 of the housing 402 extends past the edge 432 of the membrane 404.

[0048] In some embodiments, the upper cavity 414 can have a volume of between about 50 mm³ and about 75 cm³. In some embodiments, the lower cavity 416 forms an open area that has a volume between about 50 mm³ and about 25 cm³. In various embodiments, the volume of the upper cavity 414 can be substantially equal to the volume of the lower cavity 416. In other embodiments, a ratio of the volume of the upper cavity 414 to the volume of the lower cavity 416 can be greater than 1 to 1, such as greater than or equal to 2 to 1, such as greater than or equal to 3 to 1, such as greater than or equal to 4 to 1, such as greater than or equal to 5 to 1.

[0049] The hygroscopic material 406 is disposed in the upper cavity 414 between the inner surface 510 of the hollow portion 422 of the housing 402 and the membrane 404. The housing 402 is made of a non-breathable material to prevent moisture from outside of the cavity 412 from being absorbed by the hygroscopic material 406. The membrane 404 is made of a breathable material such that moisture from an air gap 418 of the lower cavity 414 can be absorbed by the hygroscopic material 406 through the membrane 404. The membrane 404 may allow moisture to move between both the upper cavity 414 and the lower cavity 416, or the membrane 204 may allow moisture to move from the lower cavity 414 to the upper cavity 416, but not allow moisture to move from the upper cavity 416 to the lower cavity. The hygroscopic material 406 is used to perform a “dry out” test on a user, or to maintain a desired moisture level of the user’s skin.

[0050] In some embodiments, the environment altering material, described as a hygroscopic material 406, is replaced with a moisture emitting material, rather than the hygroscopic material 406. The moisture emitting material can be used to perform a “hydration” test on a user, or to maintain a desired moisture level of the user’s skin. The moisture emitting material can take any suitable form, such as, for example, the form of any moisture emitting material described in the present application. In some embodiments, the environment altering material, described as a hygroscopic material 406 above, is replaced with a medication material, either in combination with one of the hygroscopic material or the moisture emitting material or by itself. The medication material is configured to emit a medication through the membrane4 and the skin of a user to provide medication to the user through a transdermal process. The medication material can take any suitable form, such as, for example, the form of any medication material described in the present application.

[0051] The optional adhesive 408 is attached to a bottom surface of the attachment portion 424 of the housing 402, and a release paper 420 is attached to the bottom surface of the housing 402 to protect the adhesive 408 prior to use of the skin patch 400. The release paper 420 is removed prior to use of the skin patch 400. The optional release paper 420 may be aligned with the edge 430 of the housing 402, or the release paper may extend past the edge 430 of the housing 402. In embodiments that do not include the adhesive 408, a large piece of flexible tape or bandage may be placed over the skin patch 400 and extend beyond the edges of the skin patch such that the extended pieces of the flexible tape or bandage can be used engage the user’ s skin to attach the skin patch to the user.

[0052] Referring to FIGS. 6-7, another embodiment of a skin patch 600 (which is a more specific embodiment of the skin patch 100 shown in FIG. 1) includes a housing 602, a membrane 604, an environment altering material, such as, for example, a hygroscopic material 606, an optional adhesive 608, and an optional release paper 620. The housing 602 includes a hollow portion 622 and an attachment portion 624. The hollow portion 622 and the attachment portion 624 can take any suitable form, such as, for example, any form described in the present application. In certain embodiments, the housing 602 may include a shell that defines a cavity 612. The housing 602 can be made of, for example, silicone, rubber, elastomeric materials, materials that include silicone, any suitable flexible material, or any other type of suitable material.

[0053] In certain embodiments, an inner surface 710 of the hollow portion 622 of the housing 602 defines a cavity 612. The membrane 604 is attached to the hollow portion 622 of the housing 602 such that the membrane 604 is positioned within the hollow portion 622 to separate the cavity 612 into an upper cavity 614 and a lower cavity 616. In some embodiments, the upper cavity 614 can have a volume of between about 50 mm³ and about 75 cm³. In some embodiments, the lower cavity 616 forms an open area that has a volume between about 50 mm³ and about 25 cm³. In various embodiments, the volume of the upper cavity 614 can be substantially equal to the volume of the lower cavity 616. In other embodiments, a ratio of the volume of the upper cavity 614 to the volume of the lower cavity 616 can be greater than 1 to 1, such as greater than or equal to 2 to 1, such as greater than or equal to 3 to 1, such as greater than or equal to 4 to 1, such as greater than or equal to 5 to 1.

[0054] The housing 602 can be attached to the membrane 604 by any suitable means, such as, for example, an adhesive, a friction-fit connection, or any other suitable type of connection. In the illustrated embodiment, the edge 632 of the membrane 604 is attached to the hollow portion 622 of the housing 602.

[0055] The hygroscopic material 606 is disposed in the upper cavity 614 between the inner surface 710 of the hollow portion 622 of the housing 602 and the membrane 604. The housing 602 is made of a non-breathable material to prevent moisture from outside of the cavity 612 from being absorbed by the hygroscopic material 606. The membrane 604 is made of a breathable material such that moisture from an air gap 618 of the lower cavity 614 can be absorbed by the hygroscopic material 606 through the membrane 604. The membrane 604 may allow moisture to move between both the upper cavity 614 and the lower cavity 616, or the membrane 604 may allow moisture to move from the lower cavity 614 to the upper cavity 616, but not allow moisture to move from the upper cavity 616 to the lower cavity. The hygroscopic material 606 is used to perform a “dry out” test on a user, or to maintain a desired moisture level of the user’s skin.

[0056] In some embodiments, the environment altering material, described as a hygroscopic material 606 is a moisture emitting material, rather than the hygroscopic material 606. The moisture emitting material can be used to perform a “hydration” test on a user, or to maintain a desired moisture level of the user’s skin. The moisture emitting material can take any suitable form, such as, for example, the form of any moisture emitting material described in the present application. In some embodiments, the environment altering material, described as a hygroscopic material 606 is a medication material, either in combination with one of the hygroscopic material or the moisture emitting material or by itself. The medication material is configured to emit a medication through the membrane and the skin of a user to provide medication to the user through a transdermal process. The medication material can take any suitable form, such as, for example, the form of any medication material described in the present application.

[0057] The optional adhesive 608 is attached to a bottom surface of the attachment portion 624 of the housing 602, and a release paper 620 is attached to the bottom surface of the housing 602 to protect the adhesive 608 prior to use of the skin patch 600. The release paper 620 is removed prior to use of the skin patch 600. The optional release paper 620 may be aligned with the edge 630 of the housing 602, or the release paper may extend past the edge 630 of the housing 602. In embodiments that do not include the adhesive 608, a large piece of flexible tape or a bandage may be placed over the skin patch 600 and extend beyond the edges of the skin patch such that the extended pieces of the flexible tape or bandage can be used engage the user’ s skin to attach the skin patch to the user.

[0058] Referring to FIG. 8, another embodiment of a skin patch 800 includes a housing 802, an environment altering material, such as, for example, a hygroscopic material 806, an optional adhesive 808, and an optional release paper. The housing 802 may include a hollow portion 822 and an attachment portion 824. The hollow portion 822 and the attachment portion 824 can take any suitable form, such as, for example, any form described in the present application. In certain embodiments, the hollow portion 822 includes a shell that defines a cavity 812. In various embodiments, the cavity 812 can have a volume of between about 50 mm³ and about 75 cm³. The housing 802 can be made of, for example, silicone, rubber, elastomeric materials, materials that include silicone, any suitable flexible material, or any other type of suitable material.

[0059] The hygroscopic material 806 is disposed in the cavity 812 such that an air gap 818 exists between the skin 801 of a user (when the skin patch 800 is attached to the user) and the hygroscopic material 806. For example, in the illustrated embodiment, an adhesive 860 connects the hygroscopic material 806 to an inner surface 810 of the housing 802 such that the gap 818 is positioned between the skin 801 of the user and the hygroscopic material 806. The hygroscopic material 806 can, however, be attached to the inner surface 810 of the housing 802 by any other suitable means. The connection between the hygroscopic material 806 and the housing 802 prevents the hygroscopic material 106 from contacting the skin 101.

[0060] A controlled environment can be created within the cavity 812 that allows the skin patch 800 to be used to test the skin of a user without exterior environmental influences adversely affecting the test results. For example, in certain embodiments, the housing 802 is made of a non-breathable material to prevent moisture from outside of the cavity 812 from being absorbed by the hygroscopic material 806. The hygroscopic material 806 can be used during a “dry out” test of the skin, or to maintain a desired moisture level of the skin, and the controlled environment prevents weather conditions from affecting the hygroscopic material.

[0061] The air gap 818 created by the connection of the hygroscopic material 806 to the housing 802 can provide the controlled environment from which the hygroscopic material can absorb moisture to dry the air adjacent to the user’s skin 101. The amount of hygroscopic material 806 may be varied to obtain desired “dryness.” Desired dryness may be, for example, less than 50% humidity, such as less than 40% humidity, such as less than 30% humidity, such as less than 20% humidity; such as less than 10% humidity. The amount of hygroscopic material 806 required to achieve a desired humidity may depend on factors such as, for example, the size of the cavity 812, the effectiveness of the material 806, the type of material 806, the objective of the testing, as well as various other potential factors.

[0062] In some embodiments, the environment altering material, described as a hygroscopic material 806 above, is a moisture emitting material, rather than the hygroscopic material 806. The moisture emitting material can be used to perform a “hydration” test on a user, or to maintain a desired moisture level of the user’s skin. The moisture emitting material can take any suitable form, such as, for example, the form of any moisture emitting material described in the present application. In some embodiments, the environment altering material, described as a hygroscopic material 806 above, is a medication material, either in combination with one of the hygroscopic material or the moisture emitting material or by itself. The medication material is configured to emit a medication through the membrane and the skin of a user to provide medication to the user through a transdermal process. The medication material can take any suitable form, such as, for example, the form of any medication material described in the present application.

[0063] The optional adhesive 808 can be attached to a bottom surface of the attachment portion 824 of the housing 802, and a release paper (not shown) can be attached to the bottom surface of the housing 802 to protect the adhesive 808. The release paper is removed prior to use of the skin patch 800. In embodiments that do not include the adhesive 808, a large piece of flexible tape or bandage may be placed over the skin patch 800 and extend beyond the edges of the skin patch such that the extended pieces of the flexible tape or bandage can be used engage the user’ s skin to attach the skin patch to the user.

[0064] While various inventive aspects, concepts and features of the inventions may be described and illustrated herein as embodied in combination with exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein, all such combinations and sub-combinations are intended to be within the scope of the present inventions. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions— such as alternative materials, structures, configurations, methods, devices and components, alternatives as to form, fit and function, and so on— may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the present inventions even if such embodiments are not expressly disclosed herein.

[0065] Additionally, even though some features, concepts or aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure; however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated.

Claims

1. A skin patch for attaching to skin of a user, the skin patch comprising: a housing having a hollow portion that defines a cavity; a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity, an environment altering material disposed in the upper cavity; an adhesive for attaching the skin patch to the skin of the user; the lower cavity includes an air gap between the membrane and a lower end of the housing.

2. The skin patch according to claim 1, wherein the housing further comprises an attachment portion.

3. The skin patch according to claim 2, wherein the adhesive is attached to the attachment portion of the housing such that the adhesive is configured to attach the attachment portion to the skin of the user.

4. The skin patch according to claim 2, wherein the membrane portion comprises an attachment portion that is attached to the attachment portion of the housing.

5. The skin patch according to claim 4, wherein the adhesive is attached to the attachment portion of the membrane such that the adhesive is configured to attach the attachment portion of the membrane to the skin of the user.

6. The skin patch according to claim 4, wherein the adhesive is attached to the attachment portion of the housing such that the adhesive is configured to attach the attachment portion of the housing to the skin of the user.

7. The skin patch according to claim 1, wherein the lower cavity is further defined by the hollow portion of the housing.

8. The skin patch according to claim 1, wherein the environment altering material is a hygroscopic material.

9. The skin patch according to claim 8, wherein the hygroscopic material comprises desiccant.

10. The skin patch according to claim 8, wherein the hygroscopic material comprises silica gel.

11. The skin patch according to claim 1, wherein the environment altering material is a moisture emitting material.

12. The skin patch according to claim 11, wherein the moisture emitting material comprises a silica gel.

13. The skin patch according to claim 1, wherein the environment altering material comprises a medication material.

14. The skin patch according to claim 1, wherein the housing and the membrane are attached by an adhesive.

15. The skin patch according to claim 1, wherein the housing and the membrane are attached by friction fit connection.

16. The skin patch according to claim 1, further comprising a release paper for protecting the adhesive prior to use of the skin patch.

17. The skin patch according to claim 1, wherein the hollow portion of the housing is made from a non -breathable material.

18. The skin patch according to claim 17, wherein the non-breathable material comprises silicone.

19. The skin patch according to claim 1, wherein the membrane is made from a breathable material.

20. The skin patch according to claim 19, wherein the breathable material comprises silicone.

21. The skin patch according to claim 1, wherein the hollow portion of the housing comprises a rounded dome shape.

22. A skin patch for attaching to skin of a user, the skin patch comprising: a housing having a hollow portion that defines a cavity and a bottom portion; and an environment altering material disposed in the cavity; an air gap located between the environment altering material and the bottom portion of the housing.

23. The skin patch according to claim 22, wherein the environment altering material is a moisture emitting material.

24. The skin patch according to claim 23, wherein the moisture emitting material is attached to the housing by an adhesive.

25. The skin patch according to claim 22, further comprising an adhesive for attaching the skin patch to the skin of the user.

26. The skin patch according to claim 25, further comprising a release paper for protecting the adhesive prior to use of the skin patch.

27. The skin patch according to claim 22, wherein the hollow portion of the housing is made from a non -breathable material.

28. The skin patch according to claim 27, wherein the non-breathable material comprises silicone.

29. The skin patch according to claim 22, wherein the environment altering material comprises a moisture emitting material.

30. The skin patch according to claim 22, wherein the environment altering material comprises a medication emitting material.

31. A skin patch for attaching to skin of a user, the skin patch comprising: a silicone shell that defines a cavity; a membrane attached to the shell such that the cavity is separated into an upper cavity and a lower cavity; hygroscopic material disposed in the upper cavity; an adhesive for attaching the skin patch to the skin of the user; an air gap in the lower cavity below the membrane.

32. The skin patch according to claim 31, wherein the silicone shell further comprises an annular projection that extends from the cavity.

33. The skin patch according to claim 32, wherein the adhesive is attached to the annular projection of the shell such that the adhesive is configured to attach the annular projection to the skin of the user.

34. The skin patch according to claim 32, wherein the membrane portion comprises an annular projection that is attached to the annular projection of the shell.

35. The skin patch according to claim 34, wherein the adhesive is attached to the annular projection of the membrane such that the adhesive is configured to attach the annular portion of the membrane to the skin of the user.

36. The skin patch according to claim 34, wherein the adhesive is attached to the annular projection of the shell such that the adhesive is configured to attach the annular projection of the shell to the skin of the user.

37. The skin patch according to claim 31, wherein the lower cavity is further defined by the shell.

38. The skin patch according to claim 31, wherein the hygroscopic material comprises desiccant.

39. The skin patch according to claim 31, wherein the hygroscopic material comprises silica gel.

40. The skin patch according to claim 31, wherein the shell and the membrane are attached by an adhesive.

41. The skin patch according to claim 31, wherein the shell and the membrane are attached by friction fit connection.

42. The skin patch according to claim 31, further comprising a release paper for protecting the adhesive prior to use of the skin patch.

43. The skin patch according to claim 31, wherein the shell is non-breathable.

44. The skin patch according to claim 31, wherein the shell is configured to allow moisture to penetrate the shell from the cavity to an exterior of the shell, and wherein the shell is configured to prevent moisture from penetrating the shell from the exterior of the shell to the cavity.

45. The skin patch according to claim 31, wherein the membrane is made from a breathable material.

46. The skin patch according to claim 45, wherein the breathable material comprises at least one of PTFE, ePTFE, and HDPE.

47. The skin patch according to claim 31, wherein the membrane is configured to allow moisture to move from the lower cavity to the upper cavity, and wherein the membrane is configured to prevent moisture from moving from the upper cavity to the lower cavity.

48. A skin patch for attaching to skin of a user, the skin patch comprising: a silicone shell that defines a cavity; a membrane attached to the shell such that the cavity is separated into an upper cavity and a lower cavity; moisture emitting material disposed in the upper cavity; an adhesive for attaching the skin patch to the skin of the user; wherein the lower cavity includes an air gap below the membrane.

49. The skin patch according to claim 48, wherein the silicone shell further comprises an annular projection that extends from the cavity.

50. The skin patch according to claim 49, wherein the adhesive is attached to the annular projection of the shell such that the adhesive is configured to attach the annular projection to the skin of the user.

51. The skin patch according to claim 49, wherein the membrane portion comprises an annular projection that is attached to the annular projection of the shell.

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52. The skin patch according to claim 51, wherein the adhesive is attached to the annular projection of the membrane such that the adhesive is configured to attach the annular portion of the membrane to the skin of the user.

53. The skin patch according to claim 51, wherein the adhesive is attached to the annular projection of the shell such that the adhesive is configured to attach the annular projection of the shell to the skin of the user.

54. The skin patch according to claim 48, wherein the lower cavity is further defined by the shell.

55. The skin patch according to claim 48, wherein the moisture emitting material comprises silica gel.

56. The skin patch according to claim 48, wherein the shell and the membrane are attached by an adhesive.

57. The skin patch according to claim 48, wherein the shell and the membrane are attached by friction fit connection.

58. The skin patch according to claim 48, further comprising a release paper for protecting the adhesive prior to use of the skin patch.

59. The skin patch according to claim 48, wherein the shell is non-breathable.

60. The skin patch according to claim 48, wherein the shell is configured to allow moisture to penetrate the shell from the cavity to an exterior of the shell, and wherein the shell is configured to prevent moisture from penetrating the shell from the exterior of the shell to the cavity.

61. The skin patch according to claim 48, wherein the membrane is made from a breathable material.

62. The skin patch according to claim 61, wherein the breathable material comprises at least one of PTFE, ePTFE, and HDPE.

63. The skin patch according to claim 48, wherein the membrane is configured to allow moisture to move from the upper cavity to the lower cavity, and wherein the membrane is configured to prevent moisture from moving from the lower cavity to the upper cavity.

64. A skin patch for attaching to skin of a user, the skin patch comprising: a silicone shell that defines a cavity; a membrane attached to the shell such that the cavity is separated into an upper cavity and a lower cavity; medication material disposed in the upper cavity; and

23 an adhesive for attaching the skin patch to the skin of the user such that the membrane and the skin of the user; wherein the lower cavity includes an air gap.

65. The skin patch according to claim 64, wherein the silicone shell further comprises an annular projection that extends from the cavity.

66. The skin patch according to claim 65, wherein the adhesive is attached to the annular projection of the shell such that the adhesive is configured to attach the annular projection to the skin of the user.

67. The skin patch according to claim 65, wherein the membrane portion comprises an annular projection that is attached to the annular projection of the shell.

68. The skin patch according to claim 67, wherein the adhesive is attached to the annular projection of the membrane such that the adhesive is configured to attach the annular portion of the membrane to the skin of the user.

69. The skin patch according to claim 67, wherein the adhesive is attached to the annular projection of the shell such that the adhesive is configured to attach the annular projection of the shell to the skin of the user.

70. The skin patch according to claim 64, wherein the lower cavity is further defined by the shell.

71. The skin patch according to claim 64, wherein the medication material comprises material capable of emitting nitrous oxide.

72. The skin patch according to claim 64, wherein the shell and the membrane are attached by an adhesive.

73. The skin patch according to claim 64, wherein the shell and the membrane are attached by friction fit connection.

74. The skin patch according to claim 64, further comprising a release paper for protecting the adhesive prior to use of the skin patch.

75. The skin patch according to claim 64, wherein the shell is non-breathable.

76. The skin patch according to claim 64, wherein the shell is configured to allow moisture to penetrate the shell from an exterior of the shell to the cavity, and wherein the shell is configured to prevent moisture from penetrating the shell from the cavity to the exterior of the shell.

77. The skin patch according to claim 64, wherein the membrane is made from a breathable material.

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78. The skin patch according to claim 77, wherein the breathable material comprises at least one of PTFE, ePTFE, and HDPE.

79. The skin patch according to claim 64, wherein the membrane is configured to allow moisture to move from the upper cavity to the lower cavity, and wherein the membrane is configured to prevent moisture from moving from the lower cavity to the upper cavity.

80. A skin patch for attaching to skin of a user, the skin patch comprising: a housing having a hollow portion that defines a cavity; a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity; wherein the lower cavity includes an air gap; and hygroscopic material disposed in the upper cavity.

81. The skin patch according to claim 80, further comprising an adhesive for attaching the skin patch to the skin of the user.

82. A skin patch for attaching to the skin of a user, the skin patch comprising: a housing having a hollow portion that defines a cavity; a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity; and wherein the lower cavity includes an air gap; and moisture emitting material disposed in the upper cavity.

83. The skin patch according to claim 82, further comprising an adhesive for attaching the skin patch to the skin of the user.

84. A skin patch for attaching to skin of a user, the skin patch comprising: a housing having a hollow portion that defines a cavity; a membrane attached to the housing such that the cavity is separated into an upper cavity and a lower cavity; and wherein the lower cavity includes an air gap; and medication material disposed in the upper cavity.

85. The skin patch according to claim 84, further comprising an adhesive for attaching the skin patch to the skin of the user.

86. A skin patch for attaching to skin of a user, the skin patch comprising: a housing having a hollow portion that defines a cavity; and hygroscopic material disposed in the cavity such that a gap exists between the hygroscopic material and the skin of the user;

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87. The skin patch according to claim 86, wherein the hygroscopic material is attached to the housing by an adhesive.

88. The skin patch according to claim 86, further comprising an adhesive for attaching the skin patch to the skin of the user.

89. The skin patch according to claim 88, further comprising a release paper for protecting the adhesive prior to use of the skin patch.

90. The skin patch according to claim 86, wherein the hygroscopic material comprises desiccant.

91. The skin patch according to claim 86, wherein the hygroscopic material comprises silica gel.

92. The skin patch according to claim 86, wherein the hollow portion of the housing is made from a non -breathable material.

93. The skin patch according to claim 92, wherein the non-breathable material comprises silicone.

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