Elastic wound dressings / skin closure materials and assemblies

Abstract

The elastic, flexible, and adaptable material 12 comprises a base material 16a, a top layer 16 having upper piles 16b and lower piles 16c extending from opposing surfaces of the base material, and an adhesive layer 18 operatively connected to the top layer, the adhesive layer comprising a silicone gel 18a. Devices such as wound dressings or wound closures, protective barriers, wound dressing covers, compression wraps, attachable anchor points, barriers, or insulators can be formed from the material. Such devices are capable of generating electrostatic charges that can promote wound healing.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the priority of U.S. Application No. 63 / 498141, filed on April 25, 2023, the content of which is incorporated herein by reference.

Background Art

[0002] This application relates to wound care, particularly to materials that can be applied directly to a wound and around the wound for use as a wound dressing or wound closure, materials that can be applied on a wound dressing for use as a wound dressing cover, or materials that complement existing technologies.

[0003] In U.S. Patent Publication No. 2023 / 0046036, which is incorporated herein by reference, a wound care dressing cover is disclosed that consists of a top fabric ply, a silicone gel layer under the top layer, and a release liner under the silicone gel layer. The silicone gel is adhered to the top fabric ply by a binder such as an acrylate adhesive that binds to the silicone gel, and the release liner is removably adhered to the silicone gel by the natural adhesive properties of the silicone gel. In a preferred embodiment, fibers extend from the underside of the top layer into the binder to further strengthen the attachment of the silicone layer to the top layer.

Summary of the Invention

Means for Solving the Problems

[0004] The wound dressing cover disclosed in the above application functions well. However, the inventors have found that the selection of specialized materials and the order of material assembly can be improved. In particular, a new material has been developed that can be used for the top ply of the assembly. In one embodiment, the new material has high elastic memory in all planar radial directions and has the ability of other materials (i.e., hook members and adhesives) to engage and / or adhere to the new material itself and can be used to cover a wound or wound dressing. In another embodiment, the new material can be used as a wound closure (e.g., to keep an incision closed) or as a combination of all three (i.e., as a wound covering, wound dressing, and wound closure).

[0005] Briefly, an elastic, flexible, and adaptable material comprising a top layer and an adhesive layer is disclosed. The top layer comprises a base material, an upper pile extending from the upper surface of the base material, and a lower pile extending from the lower surface of the base material, wherein the base material is flexible and stretchable. The adhesive layer comprises a silicone gel functionally (operatively: performing a given function) bonded to the lower pile by a binder, the binder being selected to bond to the silicone gel.

[0006] The material may include a reinforcing layer between the top layer and the silicone gel layer. The reinforcing layer is preferably formed from a polyurethane film or polyethylene film and is fixed to the top layer by a second binder. The binder of the adhesive layer bonds the silicone gel layer to the underside of the reinforcing layer. Preferably, the reinforcing layer has the same extent (identical width) as the top layer.

[0007] According to one embodiment of the material, the material may have a plurality of perforations or holes extending through at least the silicone gel and the reinforcing layer (if present). The perforations may have a diameter of about 0.5 mm to 3 mm, preferably about 1 mm to 2.8 mm, preferably about 2 mm, and the perforations may be spaced preferably about 3 to 8 mm apart, preferably about 5 mm apart. The perforations may be arranged in rows, and the rows may be spaced about 3 to 8 mm apart, preferably about 5 mm apart. The perforations in a row may be arranged in columns, or the perforations in one row may be offset from the perforations in adjacent rows.

[0008] According to one embodiment of the material, the upper pile and the lower pile each include loops or fibers extending from the upper and lower surfaces of the base material, respectively.

[0009] According to one embodiment of the material, the base material is composed of natural fibers or artificial / synthetic fibers such as nylon, spandex, Lycra, carbon fiber, oriented polytetrafluoroethylene (i.e., Gore-Tex®), polyurethane, polyethylene, and combinations thereof. If the base material is made from nylon or contains nylon, the nylon may include 50 / 17SD nylon and / or 20 / 1SD nylon. For example, the base material may have a composition of about 69% 50 / 17SD nylon and about 21% 20 / 1SD nylon, and about 10% 40 denier spandex, but is not limited thereto. Preferably, the upper pile and lower pile have the same composition as the base material.

[0010] According to one embodiment of the material, the adhesive layer may contain antimicrobial and / or antibacterial agents, which can be applied to the incision or wound and its surrounding area by application of a device formed from the material.

[0011] According to one embodiment of the material, the adhesive layer may include a series of dots, lines, or patterns that define areas having coatings of adhesive having equal or different coat weights and tackiness.

[0012] According to one embodiment of the material, when used, the material generates a triboelectric electrostatic charge and / or an electromagnetic field when applied. The electrostatic or electromagnetic field is generated by induction and is influenced by friction and conduction between the material and the wearer. In a device formed from the material, the silicone gel layer is neutral or nearly neutral in terms of electrostatic charge, and the top pile can be generated and accumulated in the device formed from the material and can transfer the thus generated electrostatic charge to the wound site. The pattern of the adhesive layer, in particular the pattern of the silicone gel, may influence the pattern of electrostatic charge flow to the wound site. The silicone gel is neutral (i.e., substantially charge-free) and, when applied to the top layer, acts as an insulator. When a device made from the material is applied to skin, the skin has its own charge / field, and the electrostatic charge of the device changes again when it comes into contact with the wearer. The charge attempts to balance but fluctuates continuously as the charges of the environment and the wearer change, generating the induction of the charge described above.

[0013] According to one embodiment of the material, the material may be part of an assembly that includes a removable liner that is removably bonded to an adhesive layer of the material.

[0014] According to one embodiment of the material, the material has elastic memory after being stretched, and when removed from a surface, the material substantially returns to its original shape, and the material can be applied to protective sheets such as removal liners.

[0015] According to one embodiment of the material, the material may include two or more layers on top of the adhesive layer.

[0016] According to one embodiment of the material, the material may be transparent to ultrasonic energy, thereby adapting the material for use in conjunction with ultrasonic technology.

[0017] According to one embodiment of the material, the silicone gel layer, binder layer, and top layer all move collinearly when the material is stretched.

[0018] According to one aspect of the material, the material, or a device formed from the material, may be formed by 3D printing.

[0019] Devices formed from the material are also disclosed. The device may be a wound covering or closure, a protective barrier, a wound dressing cover, a compression wrap, a wearable anchor point, a barrier, or an insulator.

[0020] According to one aspect of the device, the device may be worn for at least 1 day, preferably at least 3 days, preferably at least 1 week, or preferably at least 2 weeks.

[0021] According to one aspect of the device, the device can be stretched, extended, and applied between at least two points on a surface such as the patient's skin to apply a desired amount of tension / compression to the edges of the incision / wound and around the wound.

[0022] According to one aspect of the device, when the device is a wrap, the adhesive layer of the first part of the wrap engages with the upper pile of the second part of the wrap, and the wrap is connected to itself, whereby the wrap can be applied without the need for external connectors, snaps, etc.

[0023] According to one aspect of the device, the device is designed to be stretched and applied to the patient.

[0024] According to one aspect of the device, the device may include graduated markings that provide an indication of the amount of stretch of the material when the material of the device is stretched.

[0025] According to one aspect of the device, when worn, the static charge from the material of the device charges the surface of the stratum corneum (the outermost layer of the skin) under the device and the peripheral edge around the material of the device when positioned on the stratum corneum.

[0026] A tension assembly for use with a device is also disclosed. The tension assembly includes a tension member that is selectively adherable to the upper pile of the device. The tension member includes (1) an elongated, elastic, flexible elastic strip and (2) a pair of inextensible pads fixed to the bottom surface of opposite ends of the elastic strip. Each pad has a bottom surface from which hooks extend. The pads may be made of a medical grade hook material. The hooks of the pads are sized and shaped to engage and grip the upper pile of the material, thereby fixing the first end of the tension member to a selected anchor point on the material, stretching the tension member, and fixing the second end of the tension member to a second anchor point on the material spaced from the first anchor point by a distance greater than the length of the tension member before extension. By doing so, the tension member applies a desired amount of compressive force to the material and the surface beneath the material. When used, the tension member provides variable compression to the tissue beneath the skin to which the device is applied. Finally, the elongated strip of the tension member is elastic and has an elastic memory, whereby attachment of the tensioner to the device allows adjustable tension / compression in a selected area of the material.

Brief Description of the Drawings

[0027] [Figure 1A] It is a schematic perspective cross-sectional view of a preferred embodiment of a flexible material assembly. [Figure 1B] It is an enlarged fragmentary schematic cross-sectional view of the flexible material assembly taken at circle B in FIG. 1A, but with a reinforcing layer added. [Figure 1C] It is an enlarged schematic fragmentary cross-sectional view of the flexible material assembly taken at circle 1C in FIG. 1B, similar to FIG. 1B, but with the removal liner removed from the material. [Figure 1D] It is a micrograph of a cross-section of the material assembly of FIG. 1A. [Figure 1E] It is a schematic view of a material assembly with (FIG. 1F) and without (FIG. 1E) a reinforcing layer, showing the various layers / components of the material assembly. [Figure 1F]These are schematic diagrams of material assemblies with and without reinforcing layers (Figure 1F and Figure 1E), illustrating the various layers / components of the material assemblies. [Figure 2A] This is a schematic plan view of a device formed from a material assembly having a central portion surrounded by an adhesive-free edge, and multiple holes or pores in the adhesive layer and reinforcing layer. [Figure 2B] Figure 2A is a schematic cross-sectional view of the device. [Figure 3A] This is a schematic cross-sectional view of a strip of flexible material formed on a wrap, showing that the material adheres to itself. [Figure 3B] This is an enlarged view of Figure 2A, taken along circle 2B in Figure 2A. [Figure 3C] This is a micrograph taken at circle 2B in Figure 2A, showing the material adhering to itself. [Figure 4A] This is a plan view of a flexible tensile member for use with flexible materials. [Figure 4B] This is a side view of the tensile member.

[0028] The corresponding reference numerals are used throughout multiple figures in the drawing. [Modes for carrying out the invention]

[0029] The following detailed description illustrates the claimed invention without limitation, by illustrative means. This description clearly enables those skilled in the art to manufacture and use the claimed invention and describes several embodiments, adaptations, modifications, substitutions, and uses of the claimed invention, including those considered to be the best mode of currently practiced invention. Furthermore, it should be understood that the application of the claimed invention is not limited to the details of configuration and arrangement of components shown in the following description or in the drawings. Other embodiments of the claimed invention are possible and can be carried out or implemented in various ways. Also, it should be understood that the expressions and terms used herein are for illustrative purposes only and should not be considered limiting.

[0030] For example, flexible material assemblies 10 that can be used as wound dressings, wound dressing covers, or compression wraps are illustrated in Figures 1A-1C, 1E, and 1F. As described below, the material assembly 10 comprises a flexible material 12 having an adhesive underside and a removable liner 14 that is removably bonded to the underside of the material 12. The material 12 is preferably elastic and stretchable in all directions. Similar to the material shown and described in U.S. Publication No. 2023 / 0046036, the material 12 may be used to close a wound, or applied directly to the wound or around the wound, on or around the wound, or on a wound dressing. However, as described below, the materials disclosed herein have additional functionality. In particular, the materials may be used alone or as a complement to conventional closure methods.

[0031] The flexible material assembly 10 (Figures 1A and 1B) is a multilayer assembly comprising a flexible material 12 and a removable liner 14 detachably fixed to the underside of the flexible material 12. As described below, the flexible material 12 may be used to close a wound, or applied over and / or adjacent to a wound (i.e., over the periphery of the wound) or over a wound dressing (and thus may be used as a wound covering), or may be used to wrap, for example, a joint or a limb or part of the torso. The material 12 is flexible and elastic so that it can be stretched along at least one axis. Preferably, the flexible material 12 is elastically stretchable along multiple axes and is therefore elastically stretchable in any direction and tends to return to its natural state due to memory in the material when released from a stretched state.

[0032] The flexible material 12 comprises a top layer 16 (described in more detail below) and an adhesive layer 18 having viscoelastic properties. The top layer 16 may hereafter be referred to as the top ply or cover ply 16. A removal liner (or bottom ply) 14 is removably attached to the viscoelastic adhesive layer 18 to protect the adhesive layer until the flexible material 12 is deployed for use, for example, to cover a wound or wound dressing, or as a wound closure or wrap (including a compression wrap). Once the removal liner 14 is removed, the viscoelastic adhesive layer 18 is fixed, adapts as described below, and removably adheres the material 12 to a surface such as patient skin, allowing the material to be removed from the surface (e.g., skin). Because the top layer 16 and adhesive layer 18 are highly flexible and adaptable, their viscoelastic properties enhance the adhesion of the material to the skin.

[0033] In one embodiment of material 12, the top layer 16 comprises a base material 16a, which in a preferred embodiment is formed from a knitted material, a woven material, or a tricot material. The material forming the base material 16a may include artificial fibers, natural fibers, or a combination thereof. Preferably, the base material 16a is formed from a combination of fibers, at least a portion of which is an elastic fiber such as spandex (polyether-polyurea copolymer), for example, Lycra®. When formed from a combination of fibers, the elastic fibers may be combined, intertwined, or formed with natural fibers such as cotton fibers, or artificial fibers such as nylon or spandex, to form a yarn or thread from which the material for the top layer 16 is formed. The elastic fibers provide the stretchability and elasticity of the top layer 16 as described above. The base material may be, for example, about 5% to about 95% nylon and about 95% to about 5% spandex. In a preferred embodiment, the base material is about 90% nylon and about 10% spandex. Exemplary, the nylon may be SD nylon, and the spandex may be 40 denier spandex. Furthermore, the material may include different types of nylon, such as "50 / 17SD" nylon and "20 / 1SD" nylon. The two types of nylon may be combined in a ratio of about 4:1 "50 / 17SD" nylon:"20 / 1SD" nylon to about 1:4 "50 / 17SD" nylon:"20 / 1SD" nylon, preferably about 3.2:1 "50 / 17SD" nylon:"20 / 1SD" nylon. In a preferred embodiment, the material comprises about 69% "50 / 17SD" nylon, about 21% "20 / 1SD" nylon, and about 10% 40 denier spandex®. In this embodiment (i.e., including nylon), the material 12 may not be opaque, but may not be transparent enough to visualize a wound when the wound is covered by the material 12. Furthermore, in this embodiment, the base material 16a is composed of all inorganic materials, particularly materials that are generally inert and generally biocompatible. Fibers other than nylon and spandex may be used.For example, the stretchable (spandex) component of the flexible material may include silicone and / or natural rubber, and nylon may be replaced with polyethylene and / or polyurethane. The base material may be made from other types of natural fibers or artificial / industrial fibers (or a combination thereof). For example, other artificial / industrial fibers may include carbon fiber, oriented polytetrafluoroethylene (commonly known by the brand name Gore-Tex®), or other synthetic and / or conductive fibers. The top layer 16 may be made by weaving or knitting the fabric top layer as described above. If the top layer is made from an artificial material, the top layer may be formed by 3D printing.

[0034] The top layer 16 further comprises upper piles 16b and lower piles 16c, each composed of fibers, napping (fuzz), or loops extending from the upper and lower surfaces of the base material 16a, respectively, defining the upper and lower napped or brushed surfaces 16b, 16c of the top layer 16. The upper and lower piles 16b, 16c may be formed by brushing or polishing the surface of the base material 16a. Thus, the upper and lower piles 16b, 16c have the same composition as the base material 16a. The upper and lower fibers / piles / napping 16b, 16c may be straight, curved, twisted, etc., depending on how they are formed. Furthermore, the piles 16b, 16c do not have to be uniformly formed. The lower piles 16c extending from the bottom of the base material 16a significantly increase the surface area of ​​the bottom of the top layer 16 compared to a "smooth" (i.e., unnapped) material. Fibers 16b and 16c have a density of approximately 6.44 oz / yd 2 ~7.12 oz / yd 2 It has a density of approximately 6.78 oz / yd² 2 It is formed in such a way.

[0035] The material forming the top layer is absorbent. In particular, the material can absorb fluids such as exudate, blood, etc., that may leak or seep out from a wound. The top layer 16 also enhances fluid absorption, whether brushed or not. The upper and lower piles 16b, 16c increase the absorbency of the top layer 16, and the upper and lower piles create areas that can capture fluids that may leak or seep out from a wound.

[0036] In a preferred embodiment, the top layer 16 may have the following qualities / characteristics (individually or in combination): The top layer 16 (or main substrate) defines a thin, breathable membrane that can be stretched and elongated. Stretching the top layer material imparts energy to the material. This energy provides compressive force to the patient's wound and surrounding area when the material is used as a wound dressing, wound covering, or wound closure. The substrate or membrane is a semi-occlusive material, and therefore protects the skin from moisture loss. This allows for an optimal healing environment in the epidermal layer beneath the device after the material is placed on the patient. The top layer 16 includes the base layer 16a and upper and lower fibers 16b, 16c, and is approximately 6.78 to approximately 7.12 oz. / yd, as determined according to ASTM D3776. 2 It may have a basis weight of (±5%). • The top layer 16 has an elongation rate determined by a stretch test performed with a CRE tester (Zwick) 3rd cycle ASTM D4964. ○Vertical elongation: approximately 47-67%, preferably approximately 57%, and ○Weft (or weft yarn direction) elongation: approximately 40-60%, preferably approximately 50%. • The top layer has elastic memory properties. Therefore, when released from a stretched or elongated position, it tends to return to its relaxed position. The upper pile 16b and / or lower pile 16c may be formed as a 3-barn up UBL (continuous loop). The top layer 16 is die-cuttable, printable, and has excellent conversion properties (i.e., easily formed for assembly with other plies). The top layer 16 may be sterilized by methods such as autoclaving, ethylene oxide (EtO, (CH2)2O), or electron beam radiation (using gas or photon exposure). • The top layer 16 is inactive and therefore resistant to bacterial growth. • The top layer 16 is permeable to gas and vapor. The top layer 16 is highly flexible and therefore conforms to the shape of the surface to which it is applied (i.e., the patient's skin). • The top layer 16 is preferably seamless. • Acrylate, acrylic, and / or other adhesives adhere to the top side of the brushed or polished surface of the top layer 16, enabling a bond between the nylon and the adhesive.

[0037] The adhesive layer 18 is fixed to the bottom surface of the top layer 16, particularly to the bottom pile 16c, as described above. The adhesive layer adheres to the skin but does not actively bond to it, and comprises at least an adhesive 18a that is gentle on the skin during prolonged wear and removal. Thus, the material 12 is removablely attached to the patient's skin, and damage to the skin during removal of the material 12 is minimized by the use of a silicone gel adhesive. The silicone gel is nearly normal in terms of electrostatic charge. The adhesive 18a is preferably a silicone gel or hydrogel adhesive, having viscoelastic and / or high co-adhesion properties. It is applied to the bottom surface of the material 16 at a rate of about 100-350 g / m². 2 Preferably about 250 g / m 2 (~7.3 oz / yd 2) may be applied with a heavy (high) coat weight thickness. Such adhesives typically consist of a very lightly crosslinked silicone elastomer having a polymer network swollen with a silicone fluid. The silicone gel 18a has elastic properties and is stretchable in any direction and is stretched together with the top layer 16. That is, as the silicone gel is stretched, the silicone gel layer becomes thinner. The thinning of the silicone gel layer is constant, and therefore the silicone gel layer thins uniformly rather than simply thinning in one area. The same is true for the top layer 16. Thus, the silicone gel layer is collinear with the top layer 16 and remains collinear with the top layer 16 even when the material 12 is stretched.

[0038] Because the top layer 16 and the adhesive layer 18 (including the gel silicone gel layer 18b) are highly flexible and adaptable, the viscoelastic properties of the silicone layer enhance the adhesion of the material to the skin.

[0039] If necessary, the adhesive (silicone gel) 18a may be coated with and / or contain, contain, or impregnated with an integrated agent (such as an antimicrobial agent, antibacterial agent, and / or antifungal agent).

[0040] The adhesive (silicone gel) layer 18a (Figure 1A) may be applied directly to the underside of the top layer 16. However, the adhesive layer 18 preferably includes a binder 18b, which helps to fix the adhesive 18a to the bottom surface of the top ply 16 (i.e., the lower pile 16c). The binder 18b may be, for example, an acrylic or acrylate adhesive that bonds to the adhesive 18a and fixes the adhesive 18a to the cover layer 16. The binder 18b is covered by the adhesive 18a so that the acrylate adhesive binder 18b does not come into contact with the patient's skin during use. The binder 18b (bonding to silicone) adheres to the lower pile 16c. In other words, the lower pile 16c is schematically shown by shading in Figure 1E and extends into the binder 18b as shown in the micrograph in Figure 1D.

[0041] Figure 1B shows a modified example of material 12, in which a reinforcing layer 19 is provided between the lower pile 16c and the adhesive layer 18. The reinforcing layer 19 may be bonded to the lower pile 16c by an adhesive 19a, such as an acrylate binder, applied to the upper side of the reinforcing layer 19. The reinforcing layer 19 is bonded to the silicone gel 18a of the adhesive layer 18 directly (or preferably) with an acrylate binder 18b on the bottom side of the reinforcing layer (as shown in Figures 1B and 1F). The acrylate binder 19a may be the same as the acrylate binder 18b. In this case, the reinforcing layer 19 is bonded to the lower pile 16c by the acrylate binder 19a and to the silicone gel 18a by the acrylate binder 18b. The reinforcing layer 19 preferably has at least the same extent as the adhesive layer 18, and more preferably the same extent as the top layer 16. The reinforcing layer 19 may be formed from a polyurethane film or a polyethylene film and may impart a slight rigidity to the material 12, thereby preventing the material from being "floppy" and making it easier to handle, especially when wearing gloves. The reinforcing agent imparts a slight rigidity to the material 12, but the reinforcing layer 19 is stretchable in all directions and preferably elastic, and the use of the reinforcing layer 19 does not reduce the stretchability or elasticity of the material 12, as described above.

[0042] The acrylate binder 18b (in the embodiment shown in Figure 1A) or 19a (in the embodiment shown in Figure 1B) is bonded not only to the smooth underside of the base material 16a but also to the surface of the lower pile 16c, thereby increasing the contact surface area between the acrylate binder 18b / 19a and the lower pile fibers 16c. In the material 12 of Figure 1A, the acrylate binder 18b bonds the silicone gel 18a to the lower pile 16c, and in the material 12 of Figure 1B, the acrylate binder 18b bonds the silicone gel 18a to the reinforcing layer 19, and the acrylate binder 19a bonds the reinforcing layer 19 to the lower pile 16c. The increased contact area generated by the engagement of the acrylate binder 18b / 19a and the lower pile 16c significantly reduces the possibility of the silicone gel adhesive 18a separating from the top ply 16. In fact, this characteristic of the material (as shown in Figures 1A and 1E) allowed it to withstand repeated washing without significant loss of function. That is, even after multiple washes, material 12 maintained its adhesion, tackiness, flexibility, and elastic memory, continuing to adhere well to the skin and function, for example, as a wound care device (i.e., as closure and / or covering).

[0043] In one embodiment, the adhesive layer 18 may substantially cover the entire underside of the top layer 16. This embodiment may include a reinforcing layer 19, or it may not be present. If a reinforcing layer is present, the adhesive layer 18 covers the entire underside of the reinforcing layer 19. In an alternative embodiment, the adhesive layer 18 may include a series of dots, lines, or patterns comprising areas having coatings with equal or different coat weights and tackiness. This embodiment provides areas without an adhesive layer. Variations in coat weight allow for variations in the accumulation of lateral friction and shear forces when the material is fitted, as described in U.S. Publication No. 2023 / 0046036. The thicker the coat weight of the adhesive layer, the more shear force is absorbed. Also, an adhesive layer with a thicker coat weight protects the patient from undesirable and potentially harmful vertical compression and shear forces. In another alternative example, the adhesive 18 may be applied to the underside of the top layer 16 or the reinforcing layer 19 (if present) to define one or more areas without the adhesive 18.

[0044] Although material 12 is shown and described as a single-ply top layer 16, material 12 may have two or more plies 16 on top of an adhesive layer 18 or a reinforcing layer 19. Additional plies or multiple plies may be formed from the same material as the base layer 16a, or from other materials. For example, the first layer on top of the adhesive layer (or reinforcing layer) may be made from the same material as the base layer 16. The second layer, and any subsequent layers, may be made from different polymer materials, natural fibers, or combinations thereof. Furthermore, the second, third, etc. layers may be woven, knitted, tricot, or 3D printed. Furthermore, these additional layers may be selected to enhance the performance, properties, and / or functionality of material 12. Preferably, at least the top layer has an upper pile 16b. If all layers have both an upper pile and a lower pile, the napping of adjacent layers engages to help hold the layers together. To ensure that the layers do not separate, an adhesive such as an acrylate binder is used between adjacent layers to bond to the fibers of the adjacent layers.

[0045] As shown in Figures 2A and 2B, the material 12 may have holes or perforations 26 through which at least an adhesive layer 18 (including silicone gel 18a), a reinforcing layer 19 (if provided), and binders 18b and 19a pass. If necessary, the holes may also pass through the top layer 16. As seen in Figure 2A, the holes / perforations may be formed in an array covering the entire device formed from the material 12. The holes may have a diameter of, for example, about 0.5 mm to 3 mm, preferably about 1 mm to 2.8 mm, preferably about 2 mm. The centers of the holes 26 are spaced about 3 to 8 mm, preferably about 5 mm apart. The holes 26 may be formed in an array where the holes in one row are offset from the holes in adjacent rows. Alternatively, the holes in all rows may be aligned to define the columns of the array. In alternative embodiments, the perforations may be provided in a desired pattern. When such holes or perforations are provided, the permeability of the material is significantly enhanced. Furthermore, the perforated material has a very high water permeability, allowing exudate, blood, and other fluids that may be released by the wound to easily pass through the adhesive layer 18 and the reinforcing layer 19 and be absorbed into the top layer 16 by capillary action. Thus, the perforated material helps to keep these fluids away from the wound, further promoting wound healing. Moreover, the inventors have found that devices made from the material with perforations are cooler to wear than similar devices without perforations. This advantage is thought to be due to the increased breathability caused by the perforations. This enhances the comfort provided by devices formed from the material.

[0046] The removal liner 14 is preferably made from a generally non-stretchable material, which may be transparent or opaque, and is held to the adhesive 18 by the natural adhesion of the silicone adhesive 18a. The adhesive strength of the silicone gel 18a is substantially less than that of the binder 18b, and therefore, when the removal liner 14 is removed from the silicone gel 18a, the silicone gel 18a is not peeled away from the top layer 16 (or reinforcing layer 19). The material for the removal liner 14 or coating is selected by design to have low adhesion to the silicone gel 18a. As can be seen, the removal liner 14 does not come into direct contact with the top layer 16 or reinforcing layer 19. Thus, the removal liner 14 is removablely bonded to the bottom of the material 12 by the silicone adhesive layer 18. The removal liner 14 may have, for example, a fluorosilicone coating applied to the side of the removal liner that comes into contact with the silicone gel 18a. This facilitates the removal of the removal liner 14 from the material 12. Furthermore, the removal liner may be slit or perforated and / or extend beyond the perimeter of the material 12 for ease of removal and for storing the device when not in use.

[0047] [Manufacturing and use of material assemblies] For the purpose of manufacturing a material assembly 10, a flexible material 12 (consisting of a cover / top layer 16, an adhesive layer 18, and an optional reinforcing layer 19) may be supplied as a sheet assembly or in roll form to be combined with a removal liner 14. The material 12 is more elastic than the removal liner 14. Therefore, the removal liner 14 substantially stabilizes the material 12 and enables the conversion process. The removal liner 14 may have the same extent as the material 16. In this case, the removal liner may have tabs to facilitate removal of the removal liner from the material 12. Alternatively, the removal liner may be perforated so that when the material 12 is stretched, the removal liner peels off and separates from the material 12. Alternatively, the removal liner 14 may extend beyond one or more edges of the material 12 to define a gripping area to facilitate removal of the removal liner from the material 12.

[0048] In manufacturing, a single multilayer sheet is formed by positioning a cover layer 16, an optional reinforcing layer 19, and an adhesive layer 18 on a removal liner 14, thereby removably bonding the removal liner 14 to the silicone gel 18a of the adhesive layer 18. The application of the removal liner 14 to the flexible material 12 can be achieved by any desired technique. The material assembly 10 may then be cut into the desired shape by a method such as die cutting, or formed into strips and then into rolls.

[0049] In an alternative example, the adhesive layer 18 (with its binder) may be positioned on the removal liner 14. An optional reinforcing layer 19 (with its binder) may be applied on top of the adhesive layer 18. At this point, holes / perforations 26 (if necessary) may be formed by perforating holes through the removal liner 14, the adhesive layer 18, and the optional reinforcing layer 16. Next, the cover layer 16 is applied on top of the adhesive layer 18 (or the reinforcing layer 19, if present). The different layers may be laminated on top of each other. This process may be carried out in a roller and conveyor system, and the resulting material assembly 10 is wound onto a collection roller.

[0050] Alternatively, the material assembly 10 may be 3D printed. In this last case, the 3D printer may print all of the silicone adhesive layer 18a, binder 18b, optional reinforcing layer 19, lower pile 16c, base material 16a, and upper pile 16b into a specially designed configuration that may be required for a particular wound. This is useful when a non-standard sized device is required, or when the required device has a configuration that is difficult to cut from a standard sized device. This also allows the implementer to design the shape of the device required for a particular application and 3D print the material 12, which includes the adhesive layer 18 (including the silicone gel and binder), the (optional) reinforcing layer 19 and associated binder 19a, and the upper layer 16 (including the lower pile 16c, base material 16a, and upper pile 16b). The material 12 may be printed on a piece of removal liner material, or the removal liner 14 may be 3D printed together with the material 12.

[0051] The flexible material 12 is highly adaptable and can therefore conform to most three-dimensional shapes of contoured surfaces. Its lightweight (13.3-15.3 oz / yd) 2Combined with high adaptability, devices formed from material 12 (such as wound dressings / closures) may be worn for extended periods (i.e., several days, a week, two weeks, or longer). The silicone gel 18a allows such devices to be removed and reapplied with minimal to no damage to the wound or wound site. Thus, devices formed from material 12 may be repositioned when necessary. Furthermore, devices formed from material 12 may be removed, cleaned, and then reapplied without loss of tackiness and function. To further ensure that devices formed from material 12 can be reapplied, the surface to which the device is applied (i.e., the patient's skin) should be dried and cleaned before reapplication of the device so as not to contain lotions, oils, creams, and powders that may affect the tackiness of the device. Alternatively, if material 12 is not to be reapplied immediately, material 12 may be returned to the removal liner 14, which then protects the adhesive layer 18 until material 12 is reapplied. To facilitate the reapplication or return of material 12 to the removal liner, the removal liner is preferably slightly larger than material 12 (having a larger periphery). This slightly larger removal liner also facilitates the separation of the removal liner from material 12. To assist in the removal of the removal liner and the positioning of the material, assembly 10 may be provided with tabs, as described in U.S. Patent No. 9,427,222, incorporated herein by reference.

[0052] The bonding surface of material 12 (i.e., silicone gel adhesive 18a) may be cleaned, for example, using a neutral detergent and water to restore or revive the original tackiness of the silicone gel adhesive. The device formed from the material has the ability to provide tension and controlled compression as a continuous and uniform compressive force.

[0053] Material 12 may be made in different colors or levels of opacity. In one example, the top ply 16 may be formed to be clear or transparent. It is noted here that the adhesive layer 18 itself is clear or transparent. The surface of this material may be treated to affect the protection of the skin from extreme temperatures and pH fluctuations. The top layer 16 of the material may be composed of or treated with a flame retardant or other coating. Furthermore, the components / compounds may be contained in the solution / resin in which material 16 is made and can react under certain conditions (such as changes in pH, temperature, etc.) to allow monitoring of wound healing. That is, for example, if the material changes color in response to a change in pH, it is an indicator of harmfulness and may indicate that some form of medication is needed at the wound site.

[0054] Furthermore, material 12 may generate an electrostatic charge on its surface. The degree of this electrostatic charge may vary during use. The structure of the top layer 16 provides the necessary elements to generate a triboelectric electrostatic charge that is generated and accumulated on the top layer 16 and transferred to the wearer. The electrostatic charge may be amplified by brushing, which forms the pile 16a. Furthermore, material 12 acts as an electron reservoir because the electrostatic charge accumulates on the top layer 16 of the material. The electrostatic charge of the top layer is thought to be constantly changing, and this change in electrostatic charge is thought to affect the change in skin pH through an ionization process. The relationship between electrostatic charge and the change in skin pH through ionization is directly proportional. This change in pH due to the change in electrostatic charge is thought to promote healing by increasing oxygenation at the wound site. Furthermore, the change in electrostatic charge may strengthen the immune system and increase intercellular pathway communication.

[0055] Material 12 may also be transparent to ultraviolet (UV) light or radiation, as well as sound wave energy. Therefore, devices made from material 12 do not need to be removed for UV radiation therapy / treatment or ultrasound examinations. In alternative examples, material 12 may be designed to filter out UV or other undesirable frequencies or wavelengths.

[0056] In other variations, the flexible material 12 is • Suitable for long-term wear (i.e., at least 3 days, at least 1 week, at least 2 weeks, or 1 month or more), • Reusable and multiconfigurable, The system may include sensors and indicators such as gas sensors, temperature sensors, pressure sensors, moisture sensors, sensors for detecting physiological data, or any combination thereof. Such sensors may be in the form of nanotechnology sensors, spectrophotometers, chemical, thermal, and / or electrical sensors. The upper and lower piles 16b and 16c of the top layer 16 offer many advantages when the top layer material is used alone or as part of an assembly, as shown in Figures 1A and 1B.

[0057] [Application of devices formed from materials] Before application, a device formed from the flexible material 12 (which is flat when placed on a flat surface) is stretched to bias the material. When the (stretched) flexible material 12 is applied directly over the wound, tension is applied to the material 12 due to its elasticity. Applying the (stretched) material 12 to the upper and lower portions of the wound simultaneously brings the edges closer together at the moment of release of the material, closing the wound and applying linear compression to the wound due to the elasticity of the material. Furthermore, applying the material to the upper portion of the incision creates an anchor. After fixing the material to (or adjacent to) the upper portion of the incision, stretching the material and applying it to the lower portion of the incision creates a second anchor point of the material, bringing the edges of the wound closer together upon release of the material, thereby resulting in linear closure of the incision.

[0058] In an alternative method of applying material 12 to a wound or incision, the material is first stretched so that tension is applied, and then applied simultaneously under tension to the lower and upper portions of the incision. This provides linear compression to the incision. Since the device formed from the material can be removed and reapplied, these applications allow for readjustment and alignment of the wound edge, achieve customized compression by manipulating the material, and achieve the desired closure.

[0059] In a further application, the device formed from the material may be applied statically (i.e., in a relaxed, unstretched state) to or over a wound. In this application, the device functions as a wound dressing, bandage cover, or wound closure. However, it does not apply force to the wound to actively close it.

[0060] When applied, the material stabilizes the wound and surrounding area, reducing undesirable tension and pressure on the wound and surrounding area, thereby improving blood flow to the wound and reducing pain, while enhancing wound exudation and oxygenation. If the material 12 is perforated as described above, the material allows for compression of the wound (when applied as a wrap) while the wound is exudating or bleeding. In this case, exudate from the wound may pass through the material and reach the surface of the material, where it may be removed and washed away.

[0061] [Material use and devices formed from materials] In one mode of use, the material assembly 10 may be molded and sized to form a device that can be used as a wound dressing, wound closure, or wound dressing cover, in a manner similar to the device disclosed in U.S. Publication No. 2023 / 0046036, which is incorporated herein by reference. In such a device, the material 12 may be formed in any desired peripheral shape, and the removal liner 14 has at least the same extent as the flexible material 12. That is, the peripheral edge of the material assembly 10 can define a circle, ellipse, rectangle, square, crescent, X-shape, or other desired (regular or irregular) shape, or combination of shapes. Furthermore, the material assembly may be cut to a desired size or dimension. When such a wound or dressing cover formed from the material assembly 10 is applied to a patient to help keep the wound closed (or prevent separation of the wound edge), the undesirable shear forces applied by the receding excess tissue around the wound are transferred to the wound dressing.

[0062] When the flexible material 12 is used as a wound dressing, wound covering, wound closure, or a combination thereof, the material assembly 10 may be provided as pads formed in individual sizes, such as rectangular or square (i.e., 1"x2", 2"x2", 2"x4", 4"x4", 4"x8", etc.), or circular, oval, or any other desired shape. The pads may be positioned, connected, and / or assembled to form anchor points. These anchor points allow individual panels of the material to be interconnected with each other, to another device, or to another anchor. This enables a methodology for covering wounds that are intended to be left open, such as delayed healing wounds or those intended for secondary healing.

[0063] An exemplary device 20 composed of material 12 is shown in Figures 2A and 2B. This device 20 comprises a pad or central area 22 formed from material 12 having perforations 26 extending through an adhesive layer 18 and a reinforcing layer 19. The pad 22 is then surrounded by a non-perforated edge or frame 24. In this device, there are several options regarding where adhesive may be applied to allow the device to adhere to the skin. For example, the central area may have an adhesive layer and the frame 24 may not contain adhesive. Alternatively, the central area 22 may not contain adhesive and the frame 24 may have an adhesive layer. Finally, adhesive layers may be provided on both the central area and the frame. In this device, the top layer 16 is covered with an absorbent material 28 such as gauze or cotton. Next, a film 30 made of, for example, polyethylene or polyurethane covers the gauze 28 and extends from the pad 22 to form an edge 24. The absorbent material 28 may be partially fixed to the top cover 16 by interaction between the top pile 16b and the absorbent material 28. The film 30 may have an adhesive such as silicone or acrylate, which may be positioned only on the absorbent material 28 (to facilitate adhesion of the film to the central pad 20), only on the edge area 24, or over the entire length of the film 30. Preferably, the edge area 24 is provided with adhesive. In use, the device 20 is bonded to a first anchor point on the patient on one side of the wound or incision (or first stretched and then bonded to the first anchor point), and then further stretched from that first anchor point in any desired direction to be bonded to a second anchor point on the patient on the other side of the wound or incision. Because the edge 24 completely encloses the central area 22, the device can be stretched along several different axes as needed. As can be understood, in the device 20 of Figures 2A and 2B, the absorbent material absorbs the fluid that passes through the pores 26 and penetrates the material 16.

[0064] In another example, the material assembly 10 may be molded and sized to form a drape as disclosed in U.S. Patent No. 1,0849,704, which is incorporated herein by reference. The stretch and elasticity of the material 12, which is made of a fabric that is usually nylon and has stretchable fibers such as Lycra®, and the adhesive layer 18 having a thick coat weight copolymer, absorb the shear force by accumulating undesirable shear forces in the gel (such as silicone gel 18a) and transferring the energy to the base material 16a. If the shear force accumulated in the gel exceeds the design limit, the device formed from the material 12 will release or peel off from the epidermis before damage occurs, limiting the shear force applied to the patient's skin.

[0065] In a further example, the material assembly 10 may be provided for use as a compression wrap 25. In this case, the roll of material assembly 12 may be provided having, for example, a width of 2" or 4" and a length of several feet (or more), and a piece or strip of material assembly 10 of the desired length can be cut from the roll. In this latter example, the roll of material assembly may also be used to provide a wound closure of the desired length. In this case, the roll may have a width of 1 / 2", 1", or 2" at any desired length. When provided as a roll, longer lengths of the flexible material 12 may be used as a compression wrap.

[0066] When used as a compression wrap 25, the flexible material 12 may be bonded or fixed to itself, as schematically shown in Figures 3A and 3B. Thus, for example, a desired length of material 12 can be cut from a roll and used on its own to compression wrap an appendage. In this case, the first portion or end E1 of the wrap 25 overlaps the second portion or end E2 of the wrap. The silicone gel 18a of the first portion E1 engages and connects with the upper pile 16b of the top layer where the strip of material 12 overlaps itself (i.e., portion E1 overlaps portion E2). The fibers of the upper pile 16b of the lower portion E2 extend into the silicone gel 18a of the first upper portion E1, holding the two portions of material 12 together and thus holding the wrap in place, for example, around an appendage. Figure 3C is a micrograph showing this connection or engagement between the upper section E1 and the lower section E2. As can be seen, the upper pile 16b of the lower section E2 extends into the lower surface of the silicone gel 18a of the upper section E1 of the material, or otherwise adheres to it.

[0067] When used as a compression wrap, the material 12 may be provided as a strip as described above and used, for example, to wrap a joint or limb, or by wrapping around a dressing on a limb or torso to hold the dressing over a wound. In this example, the material 12 can be used on its own to apply pressure to the wound or puncture wound, thereby applying compressive force to the wound or puncture wound without requiring additional fastening devices (i.e., hook and loop fasteners, pins, tape, string, etc.). When used in this manner (i.e., to wrap a limb, joint, or torso), the material 12 may be unwound, for example, to examine the wound and then wrapped again. That is, the silicone gel layer 18a of the first upper portion E1 can be separated from the upper fibers 16b of the second lower portion E2 without affecting the functionality of the silicone gel or the fibers of the upper pile 16b. Thus, the material may be reapplied after removal. Furthermore, the material assembly 10 may be repeatedly washed or sterilized.

[0068] In these cases, the device formed from material 12 may have the following characteristics. • Memory and elasticity, • Long-term wearability, The device may be a wound dressing / closure device applied to and / or around a surgical incision or wound, by crossing the incision or other wound type, i.e., a puncture wound. When used as a closure device, the device is typically stretched or extended perpendicular to the incision, thereby allowing it to supply pressure to the edges of the wound. The device may be a wound dressing or wound closure device containing antimicrobial and / or antibacterial chemicals in a silicone gel adhesive. The device may be a wound dressing / closure device that provides a continuous and uniform amount of compression over the entire length of the incision / wound, as described in U.S. Publication No. 2023 / 0046036 incorporated herein by reference. In particular, the elasticity of the top layer 16 is generally constant over the entire top layer 16. Therefore, unless there is substantial variation in the thickness of the adhesive layer 18, the retraction force of the device formed from material 12, and thus the compressive force applied to the wound by material 12, is substantially constant. The thickness (weight) of the adhesive layer may be modified (or even changed) to produce different results. The device may be a wound dressing or wound closure device that may remain in place for an extended period of time. The device may be a wound dressing device that can be removed, cleaned and / or sterilized and reused. The device, when applied, may be a wound dressing or wound closure device that generates tension in the device to apply pressure to the underlying tissue and bring the edges of the wound closer together, as described in U.S. Public Notice No. 2023 / 0046036 above. • The device is adaptable and can be adapted, fitted, and applied to any part or area of ​​human anatomy.

[0069] In another example, the napped (fuzzed) upper surface allows for the attachment of specific devices or instruments to the material near the surgical site. For example, devices such as tensioners may be used to secure instruments or devices for tubes / lines or ostomy devices to the upper pile 16b. Alternatively, a piece of material may be bonded to a part of the device, and the device may be held to the material by the interaction of the two pieces of material (similar to a hook-and-loop (Velcro®) connection). In the latter case, the upper pile of one part of the material is pressed against the upper pile of a second part of the material. The upper piles 16b of the two parts engage and hold each other, holding the two pieces of material together.

[0070] In some cases, it may be desirable to reinforce the forces generated by a wound dressing, closure device formed from material 12, or to secure a device (such as a catheter, tube, port, etc.) to the wound dressing, closure. In these cases, the device may be used with a tensioner 30 as schematically shown in Figures 4A and 4B. The tensioner 30 typically comprises a thin, elongated (longer than wide) flexible elastic member 32 having an upper and lower surface. Medical-grade hook pads 34 are fixed to each end of the elastic member 32. Medical-grade hooks are formed as hook members 34a on their bottom surface. These hook members are sized and shaped to engage with and hold the fibers of the upper pile 16b of the device formed from material 12. The hook pads 34 may be sewn or bonded to the elastic member 32, for example. Therefore, the adjustable tensioner 30 comprises three parts: a central flexible, stretchable, elastic portion 30a having memory, and a hook portion 30b at the opposite end of the central portion 30a.

[0071] The tensioner 30 is applied to a device formed from material 12 by engaging the hook member 34a with the upper pile 16b of material 12. When the hook member 34 is applied directly to the upper surface of material 12, the hook member 34a "grabs" the upper pile 16b, and the hook member locks with the upper pile 16b. As can be understood in the given example, any point on the upper pile 16b of material 12 can act as an anchor point for the hook pad 34 of the tensioner 30. The tensioner 30 applies a controlled amount of compression to a site by first securing one end of the tensioner to material 12, stretching the tensioner 30, and then securing the other end to material 12 at another position away from the first end of the tensioner. In this use, the tensioner 30 is preferably applied to a device formed from material 12 after the device has been applied to a patient. In this manner, the tensioner 30 may also be used to apply localized force to the surface of material 16. Alternatively, the tensioner may be used to secure a device such as a tube to the material 12. In this case, the tensioner 30 acts in the form of a bracket for securing the tube to the material 12. The tensioner 30 may be supplied in different widths, lengths, and forces. Furthermore, the elastic material of the tensioner is selected and adjusted to have the desired elasticity and elastic memory, so that the tensioner 30 can provide the desired effect on localized areas and surrounding areas.

[0072] In alternative use, two separate devices formed from material 12 may be bonded to the patient at separate locations (such as opposite the wound) to form anchor points for the tensioner 30. These anchor points are used to apply compression by utilizing the tensioner which engages with the upper pile of the material. That is, the tensioner 30 extends between the two discrete anchor points. Two anchors of varying sizes and shapes may be added to and / or around the wound and connected via tension members. This configuration firmly holds the tissue in a compressed state.

[0073] In another example, the material may be a device that can be used as a surgical stage / platform having an opening for the surgeon to manipulate. The surgical wound site is held open via a retractor fixed to a platform formed from the material 12. The platform is fixed to the patient and creates a seal. At the same time, the device also acts as a platform for fixing retractors and other equipment to facilitate the procedure, as described above. That is, the device formed from the material may function as a retractor and as a platform to which medical devices such as cannulas, catheters, IV ports, etc., are fixed.

[0074] [Benefits from using the device] The application of devices made from these materials creates a complete seal around the wound from moisture and protects all the tissues beneath from pH fluctuations.

[0075] Devices made from material 12 also allow for manipulation of the relationship between transepidermal water loss (TEWL) and the device's moisture vapor transmission rate (MVTR), thereby maintaining an appropriate amount of moisture beneath the device in the epidermis.

[0076] In another embodiment, the inventors have found that when a device formed from material 12 is applied to a patient, an exchange of electrons occurs, and a small static charge or a small electromagnetic field is induced to be generated around the stratum corneum (outer layer of the epidermis) at the wound site and the device. When the material is applied, the human body generates a low-intensity electromagnetic field, which can be measured, for example, by MEG (magnetoencephalography) and MCG (magnetocardiography) devices, or even a simple electrostatic meter. The charge or electromagnetic field varies slightly depending on where the measurement is taken on the body and the surrounding environmental conditions.

[0077] Silicone gel is neutral (i.e., virtually charge-free) and acts as an insulator when applied as a top layer. Therefore, any charge from the top layer must pass through the insulating silicone. Skin, as is known, has an electric charge, which can fluctuate. The static charge of a device made from the material changes when applied to the skin due to the fact that the charges try to balance each other. However, the charge from the skin and the charge from the device fluctuate continuously. This generates the aforementioned induction of charge. The charge is extremely small. Therefore, the device can be considered a triboelectric nano-generator when applied to the skin.

[0078] Devices made from or formed from the material may or may not utilize the electron transfer and storage properties of this material. If charged, the reinforcing layer 19 is typically negatively charged, and the silicone gel layer 18a is considered neutral or nearly neutral in terms of static charge. The static charge or electromagnetic field generated by the device when applied to a wound penetrates or passes through the adhesive layer 18 of the device, beneficially influencing wound healing. Several theories exist regarding what happens in a wound and how static charge or electromagnetic fields affect wound healing. Without being bound by a specific theory, theories include the possibility that charging or EMF may affect microorganisms, oxygenation of blood at the wound site, and / or promote granulation of the wound. These effects are also thought to then affect the pH at the wound site, particularly the pH of the wound and the surrounding stratum corneum. Furthermore, the static charge or magnetic field is considered to be substantially non-dissipating (or recharged as the device is applied). Enhanced healing has been observed regardless of the mechanism by which static charge or electromagnetic field enhances healing and how the charge / field is maintained. The inventors observed that when the edges of a wound are drawn together by a material, this electrostatic charge is generated, resulting in a change in pH at the wound site. It is believed that drawing the wound edges together better preserves the fibroblasts generated within the healing matrix, thus reducing the microbial load in the wound. This, in turn, affects the pH at the wound site, which in turn reduces the likelihood and severity of infection.

[0079] It is conceivable that static charge or electromagnetic field is generated in the upper pile 16b of the top layer 16. Here, it is important that material 16, more importantly, the upper pile 16b, is substantially formed from a component that generates static charge or electromagnetic field, such as nylon. Depending on the combination of materials selected to assemble the top ply, the result can be the generation of positive or negative charge in the material assembly. For example, brushing or polishing the fibers generates negative charge up to a saturation point or increases the amount of negative charge. Furthermore, it is also conceivable that material 12 being substantially formed from carbon fiber or polytetrafluoroethylene (i.e., Gore-Tex®) fiber would allow a device formed from material 12 to generate static charge or electromagnetic field. If the device is made from wool and silicone or other natural or artificial fibers, it is conceivable that this charge will be generated.

[0080] Since various modifications can be made to the above configuration without departing from the scope of the present invention, all matters included in the above description or shown in the accompanying drawings are intended to be interpreted as illustrative rather than restrictive. For example, the silicone layer 18a may be thinner, thicker, heavier, or lighter, and have higher or lower tackiness; the elongation may be increased or decreased; and the base material on which the cover layer 16 is made may incorporate other or different materials such as polyurethane or polyethylene.

Claims

1. An elastic, flexible, and adaptable material 12, The structure comprises a top layer 16, the top layer comprising a base material 16a, an upper pile 16b extending from the upper surface of the base material, and a lower pile 16c extending from the lower surface of the base material, the base material having flexibility and elasticity. A material comprising an adhesive layer 18 containing a silicone gel 18a, wherein the silicone gel is functionally bonded to the lower pile 16c by binders 18b, 19a, and the binders are selected to be binders that bond to the silicone gel.

2. The material according to claim 1, further comprising a reinforcing layer 19 between the top layer 16 and the silicone gel layer 18a, wherein the reinforcing layer is preferably formed from a polyurethane film or a polyethylene film, the reinforcing layer 19 is fixed to the top layer 16 by a second binder 19a, the binder 18b of the adhesive layer 18 bonds the silicone gel layer 18a to the lower surface of the reinforcing layer 19, and the top layer and the silicone gel layer are on the same line when stretched.

3. The material according to claim 2, wherein the reinforcing layer has the same extent as the top layer.

4. The material according to any one of claims 1 to 3, wherein the material includes a plurality of perforations extending through at least the silicone gel and the reinforcing layer (if present).

5. The material according to claim 4, wherein the perforations have a diameter of about 0.5 mm to 3 mm, preferably about 1 mm to 2.8 mm, preferably about 2 mm, the perforations are preferably spaced about 3 to 8 mm apart, preferably about 5 mm apart, and the perforations can provide ventilation to a device formed from the material and / or provide capillary action that allows fluid to pass through at least the silicone gel and the reinforcing layer (if present).

6. The material according to claim 4 or 5, wherein the perforations are arranged in rows, and the rows are spaced about 3 to 8 mm apart, preferably about 5 mm apart.

7. The material according to claim 6, wherein the perforations in the row are arranged in a column, or the perforations in one row are offset relative to the perforations in an adjacent row.

8. The elastic flexible material according to any one of claims 1 to 7, wherein the upper pile 16b includes loops or fibers extending from the upper surface of the base material 16a, and the lower pile 16c includes loops or fibers extending from the lower surface of the base material.

9. The elastic flexible material according to any one of claims 1 to 8, wherein the base material is composed of natural fibers or artificial / synthetic fibers such as nylon, spandex, Lycra, carbon fibers, stretched polytetrafluoroethylene (i.e., Gore-Tex®), polyurethane, polyethylene, and combinations thereof.

10. The elastic flexible material according to claim 9, wherein the base material comprises nylon, preferably comprising 50 / 17 SD nylon and 20 / 1 SD nylon, and preferably the base material has a composition of about 69% 50 / 17 SD nylon and about 21% 20 / 1 SD nylon, but is not limited thereto.

11. The elastic and flexible material according to any one of claims 1 to 10, wherein the upper pile and lower pile 16b, 16c have the same composition as the base material 16a.

12. The elastic flexible material according to any one of claims 1 to 11, wherein the adhesive layer 18 may contain an antibacterial agent and / or an antimicrobial agent, and the agent can be applied to the incision or wound and its periphery by application of a device formed from the material.

13. The material according to any one of claims 1 to 12, wherein the adhesive layer 18 includes a series of dots, lines, or patterns that define areas having an adhesive coating having equal or different coat weights and tackiness.

14. The material according to any one of claims 1 to 13, wherein the material 12 is adapted to generate a triboelectric charge on the top layer 16 during use of a device formed from the material, which can then be accumulated and transferred to the wound site.

15. The material according to claim 14, wherein the silicone gel 18a is neutral or nearly neutral in terms of static charge, and the static charge must pass around the silicone gel of the adhesive layer in order to reach and affect the wound.

16. The material according to claim 14 or 15, wherein a device formed from the material 12 acts as a triboelectric nanogenerator when applied to the skin.

17. The elastic flexible material according to any one of claims 1 to 16, wherein the flexible material 12 is part of an assembly 10, and the assembly includes a removable liner 14 that is removably bonded to the adhesive layer 18 of the material 12.

18. The elastic flexible material according to any one of claims 1 to 17, wherein the material has elastic memory after stretching, and when removed from a surface, the material substantially returns to its original shape, and the material can be applied to a protective sheet such as a removal liner.

19. The elastic and flexible material according to any one of claims 1 to 18, wherein the material comprises two or more layers on the adhesive layer.

20. The material according to any one of claims 1 to 19, wherein the material is transparent to ultrasonic energy and is adapted for use in conjunction with ultrasonic technology.

21. The elastic flexible material according to any one of claims 1 to 20, wherein the silicone gel layer 18a, the binder layers 18b, 19a, and the top layer 16 all move collinearly when the material is stretched.

22. The material according to any one of claims 1 to 21, wherein the material is formed by 3D printing.

23. A device formed from a material according to any one of claims 1 to 22, wherein the device is a wound dressing or wound closure, a protective barrier, a wound dressing cover, a compression wrap, a wearable anchor point, a barrier, or an insulator.

24. The device according to claim 23, wherein the device can be worn for at least one day, preferably at least one week, or preferably at least two weeks.

25. The device according to any one of claims 23 to 24, wherein the device can be stretched, extended, and applied between at least two points on a surface such as the patient's skin to apply a desired amount of tension / compression to the edges of the incision / wound and around the wound.

26. The device according to any one of claims 23 to 24, wherein the device is a wrap, the adhesive layer of a first portion of the wrap engages with the upper pile of a second portion of the wrap, and the wrap is connected to itself, so that the wrap can be applied without requiring an external connector, snap, or the like.

27. A device formed from a material according to any one of claims 1 to 21, wherein the device is designed to be stretched and applied to a patient.

28. The device according to any one of claims 26 to 27, wherein the device includes stepped markings that provide an indicator of the amount of stretching of the material when the material 12 of the device is stretched.

29. The device according to any one of claims 21 to 28, wherein the device is formed by 3D printing.

30. The device according to any one of claims 23 to 29 and claim 14, wherein when worn, the electrostatic charge from the material 12 of the device 20 charges the surface of the skin beneath and around the material of the device when it is positioned on the wearer's skin.

31. A tension assembly for use with a device according to any one of claims 20 to 25, wherein the tension assembly 30 comprises a tension member that can be selectively adhered to the upper pile of the device, the tension member being (1) A long, slender, elastic and flexible elastic strip 32, (2) comprising a pair of pads 34 fixed to the bottom surface of the opposite end of the elastic strip, each pad having a bottom surface from which a hook 34a extends, the pads preferably being non-stretchable and preferably formed from a medical-grade hook material, The hook 34a is sized and shaped to engage with and grip the upper pile 16b, thereby fixing the first end of the tension member to a selected anchor point in the material 12, stretching the tension member, and fixing the second end of the tension member to a second anchor point on the material located at a distance greater than the length of the tension member before stretching, thereby applying a desired amount of compressive force to the material 12 and the surface beneath the material 12 in a tension assembly.

32. The tension assembly according to claim 31, wherein the tension member provides variable compression to the tissue beneath the skin to which the device is applied.

33. The tensile assembly according to any one of claims 31 to 32, wherein the elongated strip 32 is elastic and has elastic memory, thereby allowing the attachment of the tensioner to the device to enable adjustable tension / compression on a selected area of ​​the material.

Images