WO2025114837A1

WO2025114837A1 - Article for securement to skin and method of use thereof

Info

Publication number: WO2025114837A1
Application number: PCT/IB2024/061723
Authority: WO
Inventors: Abhishek Srivastava; Audrey A. Sherman; Cory M. ARTHUR; Silvia G.B. Guttmann; Thomas R. Corrigan; Di XIE; Anne C. Gold
Original assignee: Solventum Intellectual Properties Co
Current assignee: Solventum Intellectual Properties Co
Priority date: 2023-11-30
Filing date: 2024-11-22
Publication date: 2025-06-05
Anticipated expiration: 2026-05-30

Abstract

An article for securement to a skin includes a sheet. In a planar undeformed shape, the sheet defines a plane, a longitudinal axis extending along a length of the sheet, and a transverse axis disposed in the plane and extending perpendicular to the longitudinal axis. The sheet includes a plurality of walls including a set of emergent walls. Each emergent wall includes at least one skin-penetrating feature tapering to a tip. Upon being stretched along the longitudinal axis, the sheet deforms from the planar undeformed shape to a non-planar deformed shape, such that each wall rotates outwardly from the plane about the transverse axis. In the non-planar deformed shape of the sheet, the at least one skin- penetrating feature of each emergent wall extends outwardly from the plane and is configured to at least partially penetrate the skin via the tip.

Description

ARTICLE FOR SECUREMENT TO SKIN AND METHOD OF USE THEREOF

Technical Field

The present disclosure relates generally to an article for securement to a skin of a user and a method of using the article.

Background

Articles that secure to a skin of a user (also referred to as wearable articles) may be used in modern clinical and biomedical applications. The applications encompass numerous physiological tests including, but not limited to, electrocardiography (ECG), electroencephalography (EEG), electrical impedance tomography (EIT), electromyography (EMG), and electro-oculography (EOG).

However, conventional articles may be uncomfortable and/or inconvenient for the user. For example, the conventional articles may necessitate preparation of the skin before use. Additionally, the conventional articles may necessitate use of electrolyte gels on the skin. Furthermore, the conventional articles may solely rely on adhesives for securement to the skin. Adhesives, by themselves, may be inadequate for securing the conventional articles to the skin for a desired period of time. Moreover, for some skin-types, adhesives may fail to secure the conventional articles to the skin. Adhesives may also pose a significant risk of medical adhesive skin related injuries (MARSI) to users.

Summary

In a first aspect, the present disclosure provides an article for securement to a skin of a user. The article includes a sheet having a planar undeformed shape. In the planar undeformed shape, the sheet defines a plane, a longitudinal axis extending along a length of the sheet, a transverse axis disposed in the plane and extending perpendicular to the longitudinal axis, and a thickness normal to the plane. In the planar undeformed shape, the sheet includes a first major surface and a second major surface opposite to the first major surface. The second major surface is spaced apart from the first major surface with respect to the thickness of the sheet. The second major surface is configured to face the skin of the user. In the planar undeformed shape, the sheet further includes a plurality of walls defining a plurality of slits spaced apart from each other. Each wall from the plurality of walls defines a corresponding slit from the plurality of slits. Each slit from the plurality of slits extends from the first major surface to the second major surface. In the plane of the sheet, each slit further extends at least partially along the transverse axis. The plurality of slits is arranged in a Kirigami pattern, such that the sheet is stretchable along the longitudinal axis. The plurality of walls includes a set of emergent walls defining a corresponding plurality of emergent slits from the plurality of slits. The set of emergent walls is at least a sub-set of the plurality of walls. Each emergent wall from the set of emergent walls includes at least one skin-penetrating feature tapering to a tip. Upon being stretched along the longitudinal axis, the sheet deforms from the planar undeformed shape to a non-planar deformed shape, such that each wall rotates outwardly from the plane about the transverse axis. In the non-planar deformed shape of the sheet, the at least one skin-penetrating feature of each emergent wall extends outwardly from the plane and is configured to at least partially penetrate the skin of the user via the tip.

In a second aspect, the present disclosure provides a method of using the article of the first aspect. The method includes stretching the sheet along the longitudinal axis, such that the at least one skin-penetrating feature of each emergent wall extends outwardly from the plane. The method further includes penetrating the skin of the user by the at least one skin-penetrating feature of each emergent wall, such that the article is secured to the skin.

The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

Brief Description of Drawings

Exemplary embodiments disclosed herein are more completely understood in consideration of the following detailed description in connection with the following figures. The figures are not necessarily drawn to scale. Like numbers used in the figures refer to like components. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labelled with the same number.

FIG. 1A is a schematic top view of an article according to an embodiment of the present disclosure;

FIG. IB is a detailed schematic top view of a portion of the article of FIG. 1 A according to an embodiment of the present disclosure;

FIG. 1C is a schematic cross-sectional view of a portion of the article taken along a line 1-1 of FIG. 1A according to an embodiment of the present disclosure;

FIGS. 2 is a schematic top perspective view of the article of FIG. 1A with a sheet thereof stretched according to an embodiment of the present disclosure;

FIG. 3 is a schematic cross-sectional view of a portion of an article according to another embodiment of the present disclosure;

FIG. 4A is a schematic top view of an article according to another embodiment of the present disclosure;

FIG. 4B is a detailed schematic top view of a portion of the article of FIG. 4A according to an embodiment of the present disclosure;

FIG. 5 is a schematic top view of an article according to another embodiment of the present disclosure;

FIG. 6 is a schematic bottom perspective view of the article of FIG. 5 with a sheet thereof stretched according to an embodiment of the present disclosure; FIG. 7 is a schematic side perspective view of the article of FIG. 6 according to an embodiment of the present disclosure;

FIG. 8 is a schematic side view of an article according to another embodiment of the present disclosure;

FIG 9A is a schematic side view of an article including an applicator according to an embodiment of the present disclosure;

FIG 9B is a schematic side view of the article of FIG. 9A with a sheet thereof stretched according to an embodiment of the present disclosure;

FIG 9C is a schematic side view of the article of FIG. 9A secured to a skin according to an embodiment of the present disclosure;

FIG. 10A is a schematic bottom view of an article according to another embodiment of the present disclosure;

FIG. 1 OB is a schematic bottom view of an article according to yet another embodiment of the present disclosure; and

FIG. 11 is a flowchart depicting various steps of a method of using the article according to an embodiment of the present disclosure.

Detailed Description

In the following description, reference is made to the accompanying figures that form a part thereof and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense.

In the following disclosure, the following definitions are adopted.

As used herein, “a,” “an,” “the,” “at least one,” and “one or more” are used interchangeably.

As used herein as a modifier to a property or attribute, the term “generally,” unless otherwise specifically defined, means that the property or attribute would be readily recognizable by a person of ordinary skill but without requiring absolute precision or a perfect match (e.g., within +/- 20 % for quantifiable properties).

The term “substantially,” unless otherwise specifically defined, means to a high degree of approximation (e.g., within +/- 10% for quantifiable properties) but again without requiring absolute precision or a perfect match.

As used herein, all numbers should be considered modified by the term “about.” The term “about,” unless otherwise specifically defined, means to a high degree of approximation (e.g., within +/- 5% for quantifiable properties) but again without requiring absolute precision or a perfect match.

As used herein, the terms “first” and “second” are used as identifiers. Therefore, such terms should not be construed as limiting of this disclosure. The terms “first” and “second” when used in conjunction with a feature or an element can be interchanged throughout the embodiments of this disclosure.

As used herein, “at least one of A and B” should be understood to mean “only A, only B, or both A and B.”

As used herein, the term “sheet” generally refers to a material with a very high ratio of length or width to thickness. A sheet has two major surfaces defined by a length and width.

As used herein, the term “layer” generally refers to a thickness of material within a sheet that has a relatively consistent chemical composition. Layers may be of any type of material including polymeric, cellulosic, metallic, or a blend thereof. A given layer may be combined or connected to other layers to form sheets. A layer may be either partially or fully continuous as compared to adjacent layers or the sheet. A given layer may be partially or fully coextensive with adjacent layers. A layer may contain sub -layers.

As used herein, the term “skin” is used to generally refer to skin of a person, an animal, or any other matter of biological origin. Skin includes three layers, namely, epidermis, dermis, and hypodermis. Stratum corneum is the outermost layer of the epidermis and consists of dead cells (corneocytes). Penetration of the stratum corneum by any external object, such as a needle, may not cause pain.

As used herein, the term “polymer” refers to both materials prepared from one monomer, such as, a homopolymer or to materials prepared from two or more monomers, such as, a copolymer, terpolymer, or the like.

As used herein, the term “electrically connected” refers to direct coupling between components and/or indirect coupling between components via one or more intervening electric components, such that an electric signal can be passed between the two components.

As used herein, the term “controller” refers to a processor device for executing commands or instructions. A controller may include both hardware and software components, and the term “controller” is intended to broadly encompass a combination of such components.

As used herein, the term “electrode” refers to an electrical conductor configured to contact a non-metallic surface including a skin of a user (e.g., a human or an animal) and measure electrical signals corresponding to one or more physiological parameters of the user.

As used herein, the term “electrically conductive” refers to a property of an element through which readily detectable current flows under the voltages typically applied to electrodes in biosensors. The term “electrically conductive material” refers to the material possessing such a property. Nonlimiting examples of electrically conductive materials include metallic conductors, conductive polymers, and semi-conductors with appreciable conductivity.

The present disclosure relates to an article for securement to a skin of a user. The article includes a sheet having a planar undeformed shape. In the planar undeformed shape, the sheet defines a plane, a longitudinal axis extending along a length of the sheet, a transverse axis disposed in the plane and extending perpendicular to the longitudinal axis, and a thickness normal to the plane. In the planar undeformed shape, the sheet includes a first major surface and a second major surface opposite to the first major surface. The second major surface is spaced apart from the first major surface with respect to the thickness of the sheet. The second major surface is configured to face the skin of the user. In the planar undeformed shape, the sheet further includes a plurality of walls defining a plurality of slits spaced apart from each other. Each wall from the plurality of walls defines a corresponding slit from the plurality of slits. Each slit from the plurality of slits extends from the first major surface to the second major surface. In the plane of the sheet, each slit further extends at least partially along the transverse axis. The plurality of slits is arranged in a Kirigami pattern, such that the sheet is stretchable along the longitudinal axis. The plurality of walls includes a set of emergent walls defining a corresponding plurality of emergent slits from the plurality of slits. The set of emergent walls is at least a sub-set of the plurality of walls. Each emergent wall from the set of emergent walls includes at least one skin-penetrating feature tapering to a tip. Upon being stretched along the longitudinal axis, the sheet deforms from the planar undeformed shape to a non-planar deformed shape, such that each wall rotates outwardly from the plane about the transverse axis. In the non-planar deformed shape of the sheet, the at least one skin-penetrating feature of each emergent wall extends outwardly from the plane and is configured to at least partially penetrate the skin of the user via the tip.

The article of the present disclosure may be secured to the skin of the user via the at least one skin-penetrating feature in the non-planar deformed shape of the sheet. Specifically, in the non-planar deformed shape of the sheet, a plurality of skin -penetrating features corresponding to the set of emergent walls may be at least partially inserted into the skin of the user to secure the article to the skin. Advantageously, the plurality of skin-penetrating features may “bite” into the skin as a tension force along the longitudinal axis is removed from the sheet. This may further improve the securement of the article to the skin.

Due to securement via the plurality of skin-penetrating features, the article may be suitable in cases where use of adhesives for securement is not appropriate. For example, the article may be used when a longer securement time is desired than that offered by conventional articles that use adhesives for securement. Further, the article may be suitable for use for all skin types, whereas adhesives may be unsuitable for some skin types. Additionally, the article may omit a need to prepare the skin before use. The article may also prevent adhesive-related skin injuries to the user that may otherwise arise due to use of adhesives.

In some implementations, the at least one skin-penetrating feature may not penetrate the dermis of the skin. For example, the at least one skin-penetrating feature may only penetrate the stratum corneum and the viable epidermis of the skin. Consequently, the article may not cause pain to the user upon insertion of the at least one skin-penetrating feature into the skin and during use.

In some examples, in the non-planar deformed shape of the sheet, the plurality of walls defines a plurality of through channels. The plurality of through channels may provide air ventilation to the skin. The plurality of through channels may further facilitate removal of sweat from the skin. The plurality of through channels may therefore improve the physical health of the skin onto which the article is secured, especially when compared to adhesive securement of conventional articles.

In some examples, the at least one skin-penetrating feature may be electrically conductive. In such embodiments, the article may be utilized for sensing electric signals from the skin via the at least one skin-penetrating feature. In other words, the at least one skin-penetrating feature may function as an electrode. For example, the article may be used for applications encompassing numerous physiological tests including, but not limited to, electrocardiography (ECG), electroencephalography (EEG), electrical impedance tomography (EIT), electromyography (EMG), and electro-oculography (EOG). Additionally or alternatively, the article may further include an electrode for sensing electric signals from the skin.

Referring now to the Figures, FIG. 1A illustrates a schematic top view of an article 100 for securement to a skin of a user according to an embodiment of the present disclosure. FIG. IB illustrates a detailed schematic top view of a portion 50 of the article 100. FIG. 1C illustrates a schematic cross- sectional view of a portion of the article 100 taken along a line 1-1 of FIG. 1 A.

The article 100 defines mutually orthogonal x, y, and z-axes. The x and y-axes are in-plane axes of the article 100, while the z-axis is a transverse axis disposed along a thickness of the article 100. In other words, the x and y-axes are disposed along a plane (i.e., the x-y plane) of the article 100, and the z-axis is disposed perpendicular to the plane of the article 100.

The article 100 includes a sheet 110 having a planar undeformed shape 111. In the planar undeformed shape 111, the sheet 110 defines a plane 101, a longitudinal axis 102, and a transverse axis 104. The longitudinal axis 102 extends along a length of the sheet 110. The transverse axis 104 is disposed in the plane 101 and extends perpendicular to the longitudinal axis 102. In other words, the longitudinal axis 102 and the transverse axis 104 are mutually perpendicular. Furthermore, in the planar undeformed shape 111, the sheet 110 further defines a thickness 115 (shown in FIG. 1C) normal to the plane 101.

The plane 101 may correspond to the x-y plane of the article 100. The longitudinal axis 102 may extend along the x-axis of the article 100. The transverse axis 104 may extend along the y-axis of the article 100. The thickness 115 may be defined along the z-axis of the article 100.

In the planar undeformed shape 111, the sheet 110 includes a first major surface 112 and a second major surface 114 (shown in FIG. 1C) opposite to the first major surface 112. The second major surface 114 is spaced apart from the first major surface 112 with respect to the thickness 115 of the sheet 110. The second major surface 114 is configured to face the skin of the user.

In the planar undeformed shape 111, the sheet 110 further includes a plurality of walls 120 defining a plurality of slits 122 spaced apart from each other. Each wall 120 from the plurality of walls 120 defines a corresponding slit 122 from the plurality of slits 122. Each slit 122 from the plurality of slits 122 extends from the first major surface 112 to the second major surface 114 (shown in FIG. 1C) along the thickness 115 of the sheet 110. In other words, each slit 122 is a through-slit. In some embodiments, each slit 122 may extend normally to the plane 101. In the plane 101 of the sheet 110, each slit 122 further extends at least partially along the transverse axis 104.

The plurality of slits 122 is arranged in a Kirigami pattern, such that the sheet 110 is stretchable along the longitudinal axis 102. In other words, the plurality of slits 122 may be arranged in a way that allows the sheet 110 to stretch along the longitudinal axis 102. The term “Kirigami pattern” encompasses any arrangement or pattern of the plurality of slits 122 due to which each of the plurality of walls 120 rotates about the transverse axis 104 upon stretching of the sheet 110 along the longitudinal axis 102. Examples of the Kirigami pattern may include a hat pattern, a pine tree pattern, a chevron pattern with pointed spears, and the like.

The plurality of walls 120 includes a set of emergent walls 138 defining a corresponding plurality of emergent slits 136 from the plurality of slits 122. The set of emergent walls 138 is at least a sub-set of the plurality of walls 120. In other words, at least some of the plurality of walls 120 are the emergent walls 138.

Each emergent wall 138 from the set of emergent walls 138 includes at least one skinpenetrating feature 130 tapering to a tip 146. Thus, each wall 120 including the at least one skinpenetrating feature 130 may be referred to as the emergent wall 138. In some embodiments, the at least one skin-penetrating feature 130 may include a plurality of skin -penetrating features 130.

In the illustrated embodiment of FIG. 1A, each wall 120 is the emergent wall 138, such that each slit 122 is the emergent slit 136. In other words, in the illustrated embodiment of FIG. 1A, each wall 120 includes the at least one skin-penetrating feature 130. However, in some other embodiments, some of the plurality of walls 120 may not be the emergent walls 138.

Referring now to FIGS. 1 A and IB, in some embodiments, in the planar undeformed shape 111 of the sheet 110, each emergent slit 136 includes an H-shaped portion 150 and a pair of V-shaped portions 152.

The H-shaped portion 150 includes a main linear section 160 extending along the transverse axis 104. The H-shaped portion 150 further includes a pair of end linear sections 162 extending from opposing ends of the main linear section 160 along the longitudinal axis 102. The pair of V-shaped portions 152 extends from the main linear section 160 along the longitudinal axis 102, such that the emergent wall 138 includes a main linear edge 166 extending along the transverse axis 104 and at least partly defining the main linear section 160 of the H-shaped portion 150.

Further, the pair of V-shaped portions 152 extends from the main linear section 160 along the longitudinal axis 102, such that the at least one skin-penetrating feature 130 includes a pair of V-shaped skin-penetrating features 190. Each of the pair of V-shaped skin-penetrating features 190 at least partially defines a corresponding V-shaped portion 152 from the pair of V-shaped portions 152 of the emergent slit 136 and extends from the main linear edge 166 along the longitudinal axis 102. Each of the pair of V-shaped skin-penetrating features 190 tapers to the corresponding tip 146. In the illustrated embodiment of FIG. 1 A, each of the pair of V-shaped portions 152 is disposed proximal to a center of the main linear section 160.

As will be discussed in greater detail below with further reference to FIG. 2, the sheet 110 deforms upon being stretched along the longitudinal axis 102, such that each wall 120 rotates outwardly from the plane 101 about the transverse axis 104.

FIG. 2 illustrates a schematic top perspective view of a portion of the article 100 with the sheet 110 stretched along the longitudinal axis 102 (shown in FIG. 1A) according to an embodiment of the present disclosure.

Referring to FIGS. 1A and 2, upon being stretched along the longitudinal axis 102, the sheet 110 deforms from the planar undeformed shape 111 (shown in FIG. 1 A) to a non -planar deformed shape 113 (shown in FIG. 2), such that each wall 120 rotates outwardly from the plane 101 about the transverse axis 104. In other words, the sheet 110 may transition from the planar undeformed shape 111 to the non-planar deformed shape 113 upon being stretched along the longitudinal axis 102.

In the non-planar deformed shape 113 of the sheet 110, the at least one skin -penetrating feature 130 of each emergent wall 138 extends outwardly from the plane 101 and is configured to at least partially penetrate the skin of the user via the tip 146.

The article 100 may be secured to the skin of the user via the at least one skin -penetrating feature 130 in the non-planar deformed shape 113 of the sheet 110. Specifically, in the non-planar deformed shape 113 of the sheet 110, the plurality of skin -penetrating features 130 corresponding to the set of emergent walls 138 may be at least partially inserted into the skin of the user to secure the article 100 to the skin. Advantageously, the plurality of skin-penetrating features 130 may “bite” into the skin as a tension force along the longitudinal axis 102 is removed from the sheet 110. This may further improve the securement of the article 100 to the skin.

Due to securement via the plurality of skin -penetrating features 130, the article 100 may be suitable in cases where use of adhesives for securement is not appropriate. For example, the article 100 may be used when a longer securement time is desired than that offered by conventional articles that use adhesives for securement. Further, the article 100 may be suitable for use for all skin types, whereas adhesives may be unsuitable for some skin types. Additionally, the article 100 may omit a need to prepare the skin before use. The article 100 may also prevent adhesive-related skin injuries to the user that may otherwise arise due to use of adhesives.

In the planar undeformed shape 111, the at least one skin -penetrating feature 130 may have a length 144 of from 1 micron to 1000 microns along the longitudinal axis 102. In some embodiments, the length 144 of the at least one skin -penetrating feature 130 may be from 5 microns to 500 microns. Advantageously, the at least one skin -penetrating feature 130 having the length 144 of from 1 micron to 1000 microns may only penetrate the epidermis of the skin and not the dermis of the skin. For example, the at least one skin-penetrating feature 130 may only penetrate the stratum corneum and the viable epidermis of the skin. Consequently, the article 100 may not cause pain to the user upon insertion of the at least one skin-penetrating feature 130 into the skin and during use.

In some embodiments, in the non-planar deformed shape 113, the at least one skin-penetrating feature 130 may extend normally to the plane 101. In some other embodiments, in the non-planar deformed shape 113, the at least one skin -penetrating feature 130 may extend obliquely with respect to the plane 101.

In some embodiments, in the non-planar deformed shape 113, the plurality of walls 120 defines a plurality of through channels 148. The plurality of through channels 148 may provide air ventilation to the skin. The plurality of through channels 148 may further facilitate removal of sweat from the skin. The plurality of through channels 148 may therefore improve the physical health of the skin onto which the article 100 is secured, especially when compared to adhesive securement of conventional articles.

In some embodiments, the plurality of emergent slits 136 may be arranged in a plurality of columns 106 extending along the transverse axis 104 and spaced apart from each other relative to the longitudinal axis 102. In some embodiments, the emergent slits 136 disposed in each of the plurality of columns 106 are at least partially staggered with respect to the emergent slits 136 disposed in an adjacent column 106 from the plurality of columns 106 along the transverse axis 104. In such a staggered configuration, the at least one skin-penetrating feature 130 corresponding to the emergent slits 136 of adjacent columns 106 may also be staggered. This may advantageously improve securement of the article 100 to the skin of the user.

In some embodiments, the sheet 110 further includes a plurality of bridges 142. In the planar undeformed shape 111 of the sheet 110, each bridge 142 may have a rectangular shape extending along the longitudinal axis 102 and may join the respective H-shaped portions 150 of a pair of adjacent emergent slits 136 from the plurality of emergent slits 136. Specifically, each bridge 142 may join the respective H-shaped portions 150 of the pair of adjacent emergent slits 136 disposed in one column 106. In some cases, the plurality of bridges 142 may facilitate rotation of the plurality walls 120 upon stretching of the sheet 110 along the longitudinal axis 102.

In the illustrated embodiment of FIG. 2, in the non-planar deformed shape 113 of the sheet 110, the set of emergent walls 138 extends normally to the plane 101 (shown in FIG. 1A). Specifically, in the illustrated embodiment of FIG. 2, the set of emergent walls 138 is a set of folding walls 138, such that, in the non-planar deformed shape 113 of the sheet 110, the set of folding walls 138 extends normally to the plane 101. Further, in such embodiments, the at least one skin -penetrating feature 130 may also extend normally to the plane 101.

In some embodiments, the at least one skin -penetrating feature 130 is electrically conductive. In such embodiments, the article 100 may be utilized for sensing electric signals from the skin via the at least one skin-penetrating feature 130. In other words, the at least one skin -penetrating feature 130 may function as an electrode. For example, the article 100 may be used for applications encompassing numerous physiological tests including, but not limited to, electrocardiography (ECG), electroencephalography (EEG), electrical impedance tomography (EIT), electromyography (EMG), and electro-oculography (EOG). Additionally or alternatively, the article 100 may further include an electrode (not shown in FIGS. 1A-2) for sensing electric signals from the skin.

FIG. 3 illustrates a schematic cross-sectional view of a portion of an article 100’ according to another embodiment of the present disclosure. The article 100’ is substantially similar to the article 100 of FIG. 1A, with like elements designated by like reference characters. However, the article 100’ has a different configuration of each emergent slit 136 than that of the article 100. Further, the article 100’ includes one or more additional layers as compared to the article 100.

Specifically, in the illustrated embodiment of FIG. 3, in the planar undeformed shape 111, each of the plurality of emergent slits 136 tapers relative to a normal 101’ to the plane 101 from the first major surface 112 to the second major surface 114. That is, each emergent slit 136 may be tapered along the normal 101’. Each emergent slit 136 may define a first taper angle ai and a second taper angle a relative to the normal 101’. The first taper angle ai and the second taper angle Ofe may be the same or different. Each of the first taper angle ai and the second taper angle a2 may range from 1 degree to 89 degrees. In some examples, each of the first taper angle ai and the second taper angle Ofe may be from 15 degrees to 60 degrees, or more preferably from 1 degree to 45 degrees.

Furthermore, in the illustrated embodiment of FIG. 3, the article 100’ further includes an adhesive layer 117. The adhesive layer 117 is at least partially disposed on the second major surface 114 of the sheet 110. In some embodiments, the adhesive layer 117 may be discontinuous. The adhesive layer 117 may include any suitable medical adhesive. In some cases, the adhesive layer 117 may facilitate securement of the article 100’ to the skin of the user.

Referring to FIGS. 1A, and 3, in some embodiments, the sheet 110 may include a first end portion 119A and a second end portion 119B opposite to the first end portion 119A along the longitudinal axis 102. The first end portion 119A and the second end portion 119B may be free from the plurality of slits 122. The first end portion 119 A and the second end portion 119B are schematically depicted by dot hatching in FIG. 1 A for illustrative purposes. In some embodiments, the adhesive layer 117 may be disposed (preferably, in a discontinuous manner) on the second major surface 114 corresponding to the first end portion 119A and the second end portion 119B of the sheet 110. In one implementation, after adhering the first end portion 119A to the skin via the adhesive layer 117, the sheet 110 may be stretched to the non-planar deformed shape 113. Subsequently, in the non-planar deformed shape 113, the sheet 110 may be used to penetrate the skin via the at least one skin-penetrating feature 130. Then, the second end portion 119B may be adhered to the skin via the adhesive layer 117, such that the sheet 110 is retained in the in the non-planar deformed shape 113. The adhesive layer 117 may be additionally or alternatively disposed (preferably, in a discontinuous manner) on the second major surface 114 corresponding to other portions of the sheet 110. However, it may be noted that the adhesive layer 117 is optional. The adhesive layer 117 may be omitted from the article 100’. FIG. 4A illustrates a top schematic view of an article 200 according to another embodiment of the present disclosure. FIG. 4B illustrates a detailed top view of a portion 55 of the article 200. The article 200 is substantially similar to the article 100 of FIGS. 1A and IB, with like elements designated by like reference characters. However, the article 200 has a different configuration of the plurality of emergent slits 136 than that of the article 100.

Specifically, in the illustrated embodiment of FIG. 4A and 4B, the at least one skin-penetrating feature 130 includes a pair of V-shaped skin-penetrating features 195. Each of the pair of V-shaped skin-penetrating features 195 at least partially defines the corresponding V-shaped portion 152 from the pair of V-shaped portions 152 of the emergent slit 136.

Further, each of the pair of V-shaped portions 152 is disposed at a corresponding end of the main linear section 160. In other words, in the planar undeformed shape 111 of the sheet 110, one of the pair of V-shaped portions 152 may be disposed at one end of the main linear section 160 and the other of the pair of V-shaped portions 152 may be disposed at the other end of the main linear section 160. Consequently, in the illustrated embodiment of FIGS. 4A and 4B, each of the pair of V-shaped skin-penetrating features 195 is shaped as a right-angled triangle.

FIG. 5 illustrates a schematic top view of an article 300 according to another embodiment of the present disclosure. FIGS. 6 and 7 illustrate different schematic perspective views of portions of the article 300 with the sheet 110 stretched along the longitudinal axis 102 according to an embodiment of the present disclosure.

The article 300 is similar to the article 100 of FIG. 1A, with like elements designated by like reference characters. However, the article 300 has a different configuration of the plurality of slits 122 as compared to that of the article 100.

Referring to FIGS. 5-7, in some embodiments, in the planar undeformed shape 111 of the sheet 110, each emergent slit 136 is a V-shaped slit 210, such that each emergent wall 138 includes a V- shaped skin-penetrating feature 220 at least partially defining the corresponding V-shaped slit 210. The V-shaped skin-penetrating feature 220 forms the at least one skin -penetrating feature 130 and tapers to the corresponding tip 146.

Furthermore, in the planar undeformed shape 111 of the sheet 110, at least some of the plurality of slits 122 apart from the plurality of emergent slits 136 may be linear slits 222 extending along the transverse axis 104. The linear slits 222 may be arranged in a plurality of linear columns 205 spaced apart from each other along the longitudinal axis 102.

As shown in FIGS. 6 and 7, in the non-planar deformed shape 113 of the sheet 110, the V- shaped skin-penetrating feature 220 may extend outwardly from the plane 101 and may penetrate the skin of the user via the tip 146.

FIG. 8 illustrates a schematic cross-sectional view of a portion of an article 400 according to another embodiment of the present disclosure. The article 400 is substantially similar to the article 100 of FIG. 1A, with like elements designed by like reference characters. However, the article 400 has a different configuration of the sheet 110 than that of the article 100.

Specifically, in the illustrated embodiment of FIG. 8, the sheet 110 further includes a first layer 116 and a second layer 118 disposed adjacent to the first layer 116. In some embodiments, the second layer 118 may be directly adjacent to the first layer 116.

The first layer 116 at least partially defines the first major surface 112 of the sheet 110. Further, the first layer 116 includes a polymer. The polymer of the first layer 116 may include any suitable polymer, for example, cellulose acetate butyrate; cellulose acetate propionate; cellulose triacetate; poly (meth) acrylates such as polymethyl methacrylate; polyesters such as polyethylene terephthalate, and polyethylene naphthalate; copolymers or blends based on naphthalene dicarboxylic acids; polyether sulfones; polyurethanes; polycarbonates; polyvinyl chloride; syndiotactic polystyrene; cyclic olefin copolymers; and polyolefins including polyethylene and polypropylene such as cast and biaxially oriented polypropylene, and so forth.

Further, the second layer 118 at least partially defines the second major surface 114 of the sheet 110. The second layer 118 includes an electrically conductive material. The electrically conductive material of the second layer 118 may include any suitable electrically conductive material, for example, metals (e.g., silver, aluminum, copper), carbon, etc. The second layer 118 may at least partially form the at least one skin -penetrating feature 130 (shown in FIG. 1A).

The article 400 may further include a controller 450 electrically coupled to the second layer 118. The controller 450 may be configured to sense electric signals from the skin. In other words, the controller 450 may sense biosignals from the skin. The controller 450 may include any suitable electronic device, such as, for example, a microcontroller, an embedded computer, a field programmable gate array (FPGA), another suitable digital logic device, or a combination thereof. In some embodiments, the controller 450 may be disposed on the sheet 110. For example, the controller 450 may be disposed on the first major surface 112 of the sheet 110. In some other embodiments, the controller 450 may be spaced apart from the sheet 110.

FIG. 9A illustrates a schematic view of an article 500 according to another embodiment of the present disclosure. Elements of the article 500 that are similar to the article 100 of FIG. 1A are designated by like reference characters. FIG. 9B illustrates a schematic view of the article 500 with the sheet 110 in the non-planar deformed shape 113. FIG. 9C illustrates a schematic view of the article 500 secured to a skin 10 of a user.

Referring to FIG. 9A, the article 500 includes an applicator 501. The applicator 501 includes a body 510 disposed on the first major surface 112 of the sheet 110. The body 510 includes an upper surface 512 and a lower surface 514 opposite to the upper surface 512. The lower surface 514 faces the first major surface 112 of the sheet 110. The body 510 further includes a wall 515 extending between the upper surface 512 and the lower surface 514. The body 510 further includes a first connector 516 that is connected to the wall 515. The body 510 further includes a second connector 518 that is connected to the wall 515 opposite to the first connector 516.

The applicator 501 further includes a first lever 520 pivotally connected to the first connector 516. The first lever 520 includes an end 524 attached to the first major surface 112 of the sheet 110. The applicator 501 further includes a second lever 522 pivotally connected to the second connector 518. The second lever 522 includes an end 525 attached to the first major surface 112 of the sheet 110. The first lever 520 and the second lever 522 are opposite to each other and spaced apart by the body 510.

As shown in FIG. 9B, upon the first and second levers 520, 522 being pivotably moved relative to the body 510 such that the respective ends 524, 525 of the first lever 520 and the second lever 522 move away from each other, the sheet 110 stretches along the longitudinal axis 102 and the sheet 110 deforms from the planar undeformed shape 111 to the non-planar deformed shape 113.

As shown in FIG. 9C, the at least one skin-penetrating feature 130 is inserted into the skin 10 of the user to secure the article 500 to the skin 10. The skin 10 has an epidermis 11 and a dermis 12. The at least one skin-penetrating feature 130 may penetrate the epidermis 11 but not the dermis 12 of the skin 10. Advantageously, the plurality of skin-penetrating features 130 may “bite” into the skin 10 as a tension force along the longitudinal axis 102 is removed from the sheet 110.

FIG. 10A shows a schematic bottom view of an article 600 according to another embodiment of the present disclosure. The article 600 is similar to the article 500 of FIG. 9A, with like elements designated by like reference characters. However, the article 600 has a different configuration of the sheet 110 than that of the article 500.

Specifically, in the illustrated embodiment of FIG. 10A, the sheet 110 further includes a plurality of sheets 610 spaced apart from each other, such that the lower surface 514 of the body 510 includes a sheet-free zone 620. The article 600 further includes an electrode 630 disposed on the sheet- free zone 620 of the lower surface 514 of the body 510. The article 600 may further include a controller (e.g., the controller 450 of FIG. 8) electrically coupled to the electrode 630. The controller may be configured to sense electric signals from the skin.

FIG. 10B shows a schematic bottom view of an article 700 according to another embodiment of the present disclosure. The article 700 is similar to the article 500 of FIG. 9A, with like elements designated by like reference characters. However, the article 700 has a different configuration of the sheet 110 than that of the article 500.

Specifically, in the illustrated embodiment of FIG. 10B, the sheet 110 further includes an aperture 710 extending from the first major surface 112 (see FIG. 9A) to the second major surface 114 (see FIG. 9 A) of the sheet 110, such that the lower surface 514 of the body 510 includes a sheet-free zone 720. In other words, the aperture 710 is a through aperture. The article 700 further includes an electrode 730 disposed on the sheet-free zone 720 of the lower surface 514 of the body 510. The article 700 may further include a controller (e.g., the controller 450 of FIG. 8) electrically coupled to the electrode 730. The controller may be configured to sense electric signals from the skin. FIG. 11 illustrates a flowchart depicting various steps of a method 800 for using the article of the present disclosure. Specifically, the method 800 is for using the article 100 of FIGS. 1A-1C, the article 100’ of FIG. 3, the article 200 of FIGS. 4A and 4B, the article 300 of FIGS. 5-7, the article 400 of FIG. 8, the article 500 of FIGS. 9A-9C, the article 600 if FIG. 10A, and the article 700 of FIG. 10B.

At step 810, the method 800 includes stretching the sheet along the longitudinal axis, such that the at least one skin-penetrating feature of each emergent wall extends outwardly from the plane. Referring to FIGS. 1A and 2, for example, the method 800 may include stretching the sheet 110 along the longitudinal axis 102, such that the at least one skin-penetrating feature 130 of each emergent wall 138 extends outwardly from the plane 101.

In some embodiments, the sheet 110 may be stretched along the longitudinal axis 102 by hand or by an applicator (e.g., the applicator 501 of FIG. 9A).

At step 820, the method 800 further includes penetrating the skin of the user by the at least one skin-penetrating feature of each emergent wall, such that the article is secured to the skin. Referring to FIG. 1A and 9C, for example, the method 800 may include penetrating the skin 10 of the user by the at least one skin -penetrating feature 130 of each emergent wall 138, such that the article 500 is secured to the skin 10.

In some embodiments, the method 800 further includes sensing electric signals from the skin via the at least one skin -penetrating feature 130. Referring to FIG. 9C, for example, the method 800 may include sensing electric signals from the skin 10 via the at least one skin-penetrating feature 130. In some embodiments, the method 800 further includes sensing electric signals from the skin via an electrode (e.g., the electrode 630 of FIG. 10A and the electrode 730 of FIG. 10B). A controller (e.g., the controller 450 of FIG. 8) may be used to sense electrical signals from the skin.

Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.

Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations can be substituted for the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this disclosure be limited only by the claims and the equivalents thereof.

Claims

CLAIMS What is claimed is:

1. An article for securement to a skin of a user, the article comprising: a sheet having a planar undeformed shape, wherein, in the planar undeformed shape, the sheet defines a plane, a longitudinal axis extending along a length of the sheet, a transverse axis disposed in the plane and extending perpendicular to the longitudinal axis, and a thickness normal to the plane, wherein, in the planar undeformed shape, the sheet comprises: a first major surface; a second major surface opposite to the first major surface and spaced apart from the first major surface with respect to the thickness of the sheet, wherein the second major surface is configured to face the skin of the user; and a plurality of walls defining a plurality of slits spaced apart from each other, wherein each wall from the plurality of walls defines a corresponding slit from the plurality of slits, wherein each slit from the plurality of slits extends from the first major surface to the second major surface, wherein, in the plane of the sheet, each slit further extends at least partially along the transverse axis, wherein the plurality of slits is arranged in a Kirigami pattern, such that the sheet is stretchable along the longitudinal axis, wherein the plurality of walls comprises a set of emergent walls defining a corresponding plurality of emergent slits from the plurality of slits, wherein the set of emergent walls is at least a sub-set of the plurality of walls, and wherein each emergent wall from the set of emergent walls comprises at least one skin-penetrating feature tapering to a tip; wherein, upon being stretched along the longitudinal axis, the sheet deforms from the planar undeformed shape to a non-planar deformed shape, such that each wall rotates outwardly from the plane about the transverse axis, and wherein, in the non-planar deformed shape of the sheet, the at least one skin-penetrating feature of each emergent wall extends outwardly from the plane and is configured to at least partially penetrate the skin of the user via the tip.

2. The article of claim 1, wherein, in the planar undeformed shape of the sheet, each emergent slit is a V-shaped slit, such that each emergent wall comprises a V-shaped skin-penetrating feature at least partially defining a corresponding V-shaped slit, and wherein the V-shaped skin-penetrating feature forms the at least one skin-penetrating feature and tapers to the corresponding tip.

3. The article of claim 2, wherein, in the planar undeformed shape of the sheet, at least some of the plurality of slits apart from the plurality of emergent slits are linear slits extending along the transverse axis.

4. The article of claim 1 , wherein, in the planar undeformed shape of the sheet, each emergent slit comprises: an H-shaped portion comprising a main linear section extending along the transverse axis and a pair of end linear sections extending from opposing ends of the main linear section along the longitudinal axis; and a pair of V-shaped portions extending from the main linear section along the longitudinal axis, such that: the emergent wall comprises a main linear edge extending along the transverse axis and at least partly defining the main linear section of the H-shaped portion; and the at least one skin-penetrating feature comprises a pair of V-shaped skinpenetrating features, wherein each of the pair of V-shaped skin -penetrating features at least partially defines a corresponding V-shaped portion from the pair of V-shaped portions of the emergent slit and extends from the main linear edge along the longitudinal axis, and wherein each of the pair of V-shaped skin-penetrating features tapers to the corresponding tip.

5. The article of claim 4, wherein the sheet further comprises a plurality bridges, wherein, in the planar undeformed shape of the sheet, each bridge has a rectangular shape extending along the longitudinal axis and joins the respective H-shaped portions of a pair of adjacent emergent slits from the plurality of emergent slits.

6. The article of claim 4, wherein each of the pair of V-shaped portions is disposed proximal to a center of the main linear section.

7. The article of claim 4, wherein each of the pair of V-shaped portions is disposed at a corresponding end of the main linear section.

8. The article of claim 1, wherein the set of emergent walls is a set of folding walls, such that, in the non-planar deformed shape of the sheet, each of the set of folding walls extends normally to the plane.

9. The article of claim 1, wherein the sheet further comprises: a first layer comprising a polymer and at least partially defining the first major surface of the sheet; and a second layer disposed adjacent to the first layer and comprising an electrically conductive material, the second layer at least partially defining the second major surface of the sheet, wherein the second layer at least partially forms the at least one skin-penetrating feature.

10. The article of claim 9, further comprising a controller electrically coupled to the second layer, wherein the controller is configured to sense electric signals from the skin.

11. The article of claim 1, further comprising an applicator, the applicator comprising: a body disposed on the first major surface of the sheet, the body comprising: an upper surface; a lower surface opposite to the upper surface, wherein the lower surface faces the first major surface of the sheet; a wall extending between the upper surface and the lower surface; a first connector that is connected to the wall; and a second connector that is connected to the wall opposite to the first connector; a first lever pivotally connected to the first connector, wherein the first lever comprises an end attached to the first major surface of the sheet; and a second lever pivotally connected to the second connector, wherein the second lever comprises an end attached to the first major surface of the sheet; wherein, upon the first and second levers being pivotably moved relative to the body such that the respective ends of the first lever and the second lever move away from each other, the sheet stretches along the longitudinal axis and the sheet deforms from the planar undeformed shape to the non-planar deformed shape.

12. The article of claim 11, wherein the sheet further comprises a plurality of sheets spaced apart from each other, such that the lower surface of the body comprises a sheet -free zone, and wherein the article further comprises an electrode disposed on the sheet-free zone of the lower surface of the body.

13. The article of claim 12, further comprising a controller electrically coupled to the electrode, wherein the controller is configured to sense electric signals from the skin.

14. The article of claim 11, wherein the sheet comprises an aperture extending from the first major surface to the second major surface of the sheet, such that the lower surface of the body comprises a sheet-free zone, and wherein the article further comprises an electrode disposed on the sheet-free zone of the lower surface of the body.

15. The article of claim 14, further comprising a controller electrically coupled to the electrode, wherein the controller is configured to sense electric signals from the skin.

16. The article of claim 1, wherein the at least one skin -penetrating feature comprises a plurality of skin-penetrating features.

17. The article of claim 1, wherein the plurality of emergent slits is arranged in a plurality of columns extending along the transverse axis and spaced apart from each other relative to the longitudinal axis.

18. The article of claim 17, wherein the emergent slits disposed in each of the plurality of columns are at least partially staggered with respect to the emergent slits disposed in an adjacent column from the plurality of columns along the transverse axis.

19. The article of claim 1, wherein, in the non-planar deformed shape, the at least one skinpenetrating feature extends normally to the plane.

20. The article of claim 1, wherein, in the non-planar deformed shape, the at least one skinpenetrating feature extends obliquely with respect to the plane.

21. The article of claim 1, wherein the at least one skin -penetrating feature is electrically conductive.

22. The article of claim 1, further comprising an adhesive layer at least partially disposed on the second major surface of the sheet.

23. The article of claim 1, wherein, in the planar undeformed shape, each of the plurality of emergent slits tapers relative to a normal to the plane from the first major surface to the second major surface.

24. The article of claim 1 , wherein, in the planar undeformed shape, the at least one skin-penetrating feature has a length of from 1 micron to 1000 microns along the longitudinal axis.

25. The article of claim 24, wherein the length is from 5 microns to 500 microns.

26. The article of claim 1, wherein, in the non-planar deformed shape, the plurality of walls defines a plurality of through channels.

27. A method of using the article of claim 1, the method comprising: stretching the sheet along the longitudinal axis, such that the at least one skin-penetrating feature of each emergent wall extends outwardly from the plane; and penetrating the skin of the user by the at least one skin-penetrating feature of each emergent wall, such that the article is secured to the skin.

28. The method of claim 27, wherein the sheet is stretched along the longitudinal axis by hand or by an applicator.

29. The method of claim 27, further comprising sensing electric signals from the skin via the at least one skin-penetrating feature.