Wound dressing

Abstract

This invention relates to an integrated wound treatment product (100) having a skin substitute (102) in direct contact with a polymer contact layer (104). The polymer contact layer (104) has sufficient adhesiveness to eliminate the need for an adhesive between the polymer contact layer (104) and the skin substitute (102). The wound treatment product (100) is configured to allow the skin substitute (102) and the polymer contact layer (104) to be immersed together in a saline solution to hydrate the skin substitute (102) without compromising the adhesiveness or adhesion of the polymer contact layer (104).

Description

Technical Field

[0001] This invention generally relates to wound treatment products for stabilizing, protecting and / or repairing damaged tissues, and methods for manufacturing the same. Background Technology

[0002] The skin, the largest organ in the human body, acts as a protective barrier against physical damage (such as wounds) and foreign objects. A wound is defined as a continuous break in the skin. When the skin is damaged, microorganisms can contaminate and infect the wound. Wounds can be divided into two categories: acute wounds and chronic wounds. Acute wounds usually heal effectively, following the natural stages of hemostasis, inflammation, proliferation, and remodeling. Chronic wounds, however, do not follow these natural stages, remaining in an inflammatory state and often "stagnating" at some natural stage of wound healing. If left untreated, chronic wounds can worsen and even lead to fatal complications.

[0003] Wound care products and dressings should utilize the natural principles of wound healing. That is, wound care products should provide a moist environment to optimize healing. However, the warm, moist environment created by a wound (e.g., an ulcer) also provides an ideal environment for bacterial growth. Excessive exudate may indicate infection, while reduced exudate may indicate poor arterial circulation or that the infection is subsiding. Therefore, proper drainage of wound exudate is necessary to promote effective healing.

[0004] Existing wound dressings can be categorized in several ways based on their function in the wound, material type, and physical form. Foam dressings (e.g., Lyofoam™, Allevyn™, Tielle™) provide sufficient absorbency and insulation, but their strong adhesion can cause dermatitis. Low-adhesion dressings (e.g., Melolin™, Mepore™, and Mepitel™) are inexpensive and generally hypoallergenic; however, these dressings have limited absorbency and are only suitable for mild exudation and superficial wounds, not other types of wounds. Silver-containing dressings have broad-spectrum antibacterial properties, but there are controversial issues, such as limitations due to hypersensitivity reactions and increased manufacturing costs. Hydrogel excipients (e.g., Intrasite™, Nu-gel™, Aquaform™) have gel properties and contain starch polymers with a high water content. Hydrogel excipients are primarily used to provide moisture to dry, necrotic wounds; however, their absorbency is limited, they require tape fixation, and their unstable or easily altered porosity makes them unsuitable for continuously exudating wounds. Therefore, there is a need for an improved dressing that can: (1) provide sufficient adhesiveness to remain fixed to the wound site without causing dermatitis; (2) have low allergenicity; (3) be cost-effective; and (4) require no additional adhesives or tapes for fixation.

[0005] Another principle behind wound healing is the potential of dressings or treatment products to help control infection. The field of regenerative medicine focuses on promoting the growth and proliferation of host cells at the site of injury to achieve the growth and replacement of damaged tissue, thereby shortening healing time and providing a more durable solution. Currently, numerous human, animal, and synthetic materials have been described or used in medical procedures to repair, restore, or correct tissue defects.

[0006] For example, the Integra® skin regeneration template (“Integra template”) has two layers: a thin silicone outer layer and a thick inner matrix layer composed of pure bovine collagen and glycosaminoglycans (GAGs). Both collagen and GAGs are normal components of human skin. The collagen is extracted from bovine tendon collagen, and the glycosaminoglycans are extracted from shark cartilage. However, the Integra template has limitations; it is relatively expensive and requires a secondary surgery for skin grafting onto the new skin layer.

[0007] The Integra template requires processing multiple covering layers, including removing the first and second covering layers sequentially before immersing it in sterile saline solution, individually trimming the template to fit the wound, and individually securing the template in place using staples or sutures. This process delays template application to the wound and increases the risk of product misplacement. Furthermore, because the silicone layer is independently designed, there is a potential issue of applying it backwards, potentially missing the crucial step of directly applying the collagen template layer to the wound.

[0008] U.S. Patent Application US 2003 / 0059460, filed September 24, 2022, discloses a hybrid polymer material comprising synthetic and natural polymers that can regenerate biological tissues. This hybrid material comprises a cross-linked, naturally occurring polymer and a biodegradable, absorbable synthetic polymer. However, producing such a hybrid material requires a series of complex process steps. Furthermore, the resulting hybrid material may contain both synthetic and natural materials.

[0009] Furthermore, U.S. Patent 8,613,957, issued December 24, 2013 (which is incorporated herein by reference), describes an exemplary scaffold material for wound care and other tissue healing applications, comprising a decellularized extracellular matrix derived from fish skin. This decellularized fish skin product provides a complete scaffold to support the ingrowth of endothelial and epithelial cells. The decellularized fish skin scaffold material is also biocompatible and can therefore be integrated into the host. MariGen™ is a commercially available skin alternative made from lightly processed skin of wild-caught Atlantic cod from Iceland. Fish skin is structurally similar to human skin, having three basic layers: the epidermis, dermis, and subcutaneous tissue. It contains proteins, lipids, fatty acids, and other bioactive compounds homologous to human skin. MariGen™ can be used to address chronic wounds such as diabetic wounds, pressure ulcers, vascular ulcers, and leaking wounds typically treated in private clinics and wound care centers.

[0010] The inventors of this invention discovered problems with assembling acellular matrix similar to that used in MariGen™ with separate fixation or safety layers. Processing multiple components, such as the acellular matrix and fixation layer, separately increases the risk of unsanitary conditions and improper treatment. Therefore, a one-piece, sterile solution is needed to simplify the operation and processing of regenerative wound care.

[0011] In particular, there is a need for an integrated sterile wound care product that can: (1) protect the wound and skin substitutes; (2) expedite the application process to the wound; and (3) simplify manufacturing and inventory management. The wound care product described in this invention meets these needs and offers numerous advantages over the prior art. Summary of the Invention

[0012] This invention proposes an improved, integrated wound treatment product for supporting wound tissue regeneration. The wound treatment product comprises a skin substitute, an integrated, low-adhesion polymer contact layer, and a release liner. The polymer contact layer preferably comprises an elastomeric layer and a hydrophobic membrane. The release liner is disposed on and in direct contact with the elastomeric layers of the skin substitute and the polymer contact layer.

[0013] The skin substitute can be easily placed between the polymer contact layer and the release liner. The skin substitute is constructed to be immersed in a saline solution along with both the polymer contact layer and the release liner to achieve hydration. This capability simplifies the preparation of wound care products before application to the wound.

[0014] In one embodiment, the skin substitute is selected from the group consisting of cowhide, pigskin, biosynthetic skin, and fish skin. While research evidence suggests that fish skin grafts are a preferred embodiment, cowhide, pigskin, or biosynthetic skin can certainly also be used as effective skin substitutes according to the invention, and may be preferred embodiments of the skin substitutes conceived in the invention under certain conditions or considerations.

[0015] In one embodiment, the skin substitute or graft material is an acellular dermal matrix. An acellular dermal matrix is ​​a biological scaffold material, such as a fish skin product, constructed to be absorbed and grown into by skin cells during wound healing. The acellular dermal matrix may include decellularized, freeze-dried fish skin.

[0016] In one embodiment, the acellular dermal matrix comprises lipids derived from the lipid layer of decellularized fish skin to promote the natural healing process of human skin. In a preferred embodiment, the skin substitute comprises extracellular matrix articles in a three-dimensional form, in granular, sheet-like, or mesh-like manner, to enhance structural support and improve tissue regeneration and cell ingrowth.

[0017] Furthermore, in one embodiment, the skin substitute may have an opening structure. An opening structure can be defined as a slot extending through the thickness of the skin substitute. In one embodiment, the opening structure is formed in a spiral shape. Providing at least one opening structure to the skin substitute allows for proper drainage of exudate from the wound during the healing process. It should be understood that, in the context of the various embodiments and their methods of use, the terms "fluid," "moisture," and "exudate" are used interchangeably with respect to the wound and wound dressing.

[0018] The skin substitute is in direct contact with a removable protective polymer matrix (i.e., a polymer contact layer). In one embodiment, the protective polymer matrix comprises a hydrophobic film layer and an elastomer layer. The wound treatment product is configured to be applied to a wound such that the skin substitute is in contact with the wound, and the polymer contact layer covers the skin substitute, wherein the polymer contact layer provides additional wound coverage.

[0019] Advantageously, the elastomeric layer is in direct contact with the skin graft material to hold the skin substitute in place, while exhibiting low adhesiveness, allowing for easy separation of the elastomeric layer from the skin substitute after proper tissue regeneration and healing at the wound site. The elastomeric layer is biocompatible with the skin and provides a gentle adhesive bond for proper fixation to the skin and painless separation after healing. The elastomeric layer has sufficient adhesiveness to eliminate the need for an adhesive between the elastomeric layer and the skin graft material.

[0020] The polymer contact layer, comprising an elastomer layer and a hydrophobic membrane layer, is hydrophobic, allowing the wound treatment product to be soaked in a saline solution before application to the skin. Advantageously, the elastomer layer retains its low adhesiveness after soaking. The protective polymer matrix's elastomer layer is configured to facilitate easy detachment from the skin graft material after it has been applied to the wound and after a period of time (e.g., preferably a period allowing cell ingrowth and tissue regeneration at the wound site). In one embodiment, this period can be up to fourteen days, or a period or time window allowing cell ingrowth and tissue regeneration at the wound site.

[0021] In one embodiment, the polymer contact layer has a predetermined porosity to allow wound exudate to pass through its thickness. The predetermined porosity defines the distribution of pores over the surface area of ​​the polymer contact layer. The pore distribution is configured to adequately facilitate the conduction of wound exudate while allowing sufficient contact between the surface area of ​​the elastomer layer and the skin to maintain gentle adhesion.

[0022] In one embodiment, the release liner comprises a polyolefin film. The release liner is hydrophobic, allowing the wound treatment product to be soaked in a saline solution before application to the skin. The release liner can protect the surfaces of the elastomeric layer and the skin substitute that come into contact with the skin and wound, respectively, from contamination before application of the wound treatment product. The release liner allows for aseptic handling of the wound treatment product.

[0023] In one embodiment, the release liner is transparent to allow observation of the skin substitute and the integrally bonded polymer contact layer. The release liner preferably includes at least one tear tab to facilitate separation of the release liner from the skin substitute and elastomer layer. The tear tab or incision is provided on the release liner to allow easy grasping and peeling of the release liner from the wound treatment product before it is applied to the wound. In one embodiment, the release liner includes a first sheet and a second sheet, wherein the second sheet of the release liner overlaps a portion of the first sheet. This portion of the first sheet is thus positioned between the second sheet and the acellular dermal matrix.

[0024] In one embodiment, a wound treatment product is manufactured by integrally combining a skin substitute with a polymer contact layer. The method of manufacturing the wound treatment product includes: obtaining fish skin, decellularizing the fish skin, freeze-drying the decellularized fish skin, and cutting the freeze-dried fish skin to a predetermined size. The step of integrally combining the decellularized, freeze-dried fish skin with the polymer contact layer (e.g., a pre-fabricated hydrophobic membrane coated with silicone) includes placing the decellularized, freeze-dried fish skin between the polymer contact layer and a peelable release liner.

[0025] The manufacturing tool opens the release liner just enough to precisely place the skin substitute onto the elastomer layer and allows for easy reassembly of the release liner without loss of adhesion or product misalignment. Thus, the peelable release liner is in direct contact with the elastomer layer of the polymer contact layer, and the decellularized, freeze-dried fish skin is positioned between the peelable release liner and the elastomer layer.

[0026] In addition, the polymer contact layer acts as an additional wound covering to protect the dermal matrix of the fish, while the elastomeric layer serves as a low-adhesion contact layer for contact with the skin surrounding the wound. However, the acellular dermal matrix is ​​constructed to directly contact the low-adhesion elastomeric layer because the elastomeric layer has sufficient adhesiveness to hold the acellular dermal matrix in place before application to the patient's wound. During the removal of the polymer contact layer, the acellular dermal matrix can remain on or integrate into the wound and can be absorbed by the wound during the healing process.

[0027] The method may also include encapsulating the assembled, one-piece wound treatment product within a synthetic flash-evaporated high-density polyethylene fiber package. The method may also include sterilizing the wound treatment product. Therefore, the entire wound treatment product can be immersed in a sterile saline solution before being applied to the wound without losing its low adhesiveness. Thus, the one-piece wound treatment product can be processed aseptically. After immersion in the sterile saline solution, the release liner can be removed before applying the wound treatment product to the wound.

[0028] This wound management product offers a significant improvement in wettability compared to existing skin grafts and wound dressings. The hydrophobic properties of the polymer contact layer (including the release liner) allow for the immersion and hydration of the skin substitute without compromising the adhesiveness or tackiness of the elastomer layer. This wound management product saves practitioners time by eliminating the need for conventional fixation methods using traditional adhesives during skin grafting and allows users to hydrate the component before placing it on the wound without the need for additional fixation devices. Therefore, the disclosed all-in-one wound management product provides practitioners and patients with rapid and efficient wound care management.

[0029] Many other advantages and features of the invention will become more apparent from the following detailed description, the accompanying examples, the drawings, and the claims. Attached Figure Description

[0030] The various features, aspects, and advantages of the technology in this invention can be better understood by combining the following description, the appended claims, and the accompanying drawings. Those skilled in the art will understand that the features shown in the drawings are for illustrative purposes only and various changes (including different or additional features and their arrangements) can be made.

[0031] Figure 1 A perspective view of an embodiment of the wound treatment product of the present invention is shown.

[0032] Figure 2 A three-dimensional view of the skin graft material used in the disclosed wound care products is shown.

[0033] Figure 3 A three-dimensional view of the polymer contact layer used in the disclosed wound care product is shown.

[0034] Figure 4 A top view is shown of a skin graft material integrally bonded with a polymer contact layer in one embodiment of a wound care product.

[0035] Figure 5 The image shows a top view of the release liner used in the disclosed wound care products.

[0036] Figure 6 A cross-sectional view of an embodiment of the wound treatment product of the present invention is shown.

[0037] Figure 7 The image shows a cross-sectional view of a wound treatment product applied to a wound surface.

[0038] Figure 8 The image shows a cross-sectional view of the removal of the polymer contact layer at the wound site.

[0039] Figure 9 A perspective view of an embodiment of the wound treatment product of the present invention is shown.

[0040] Figure 10 A perspective view of an alternative embodiment of the wound treatment product of the present invention is shown.

[0041] Figure 11 A perspective view of an alternative embodiment of the wound treatment product of the present invention is shown.

[0042] Figure 12 Showing Figure 11 A three-dimensional view of the skin grafting material used in the embodiments.

[0043] Figure 13 Showing Figure 11 A top view of the grafting material used in the embodiments.

[0044] Figure 14 An exemplary manufacturing method of an embodiment of the wound treatment product of the present invention is shown.

[0045] Figure 15 An exemplary assembly method of an embodiment of the wound treatment product of the present invention is shown.

[0046] The accompanying drawings are intended to illustrate exemplary implementations and are not drawn to scale. It should be understood that the embodiments and their usage are not limited to the arrangements and means shown in the drawings.

[0047] definition

[0048] To further facilitate understanding of embodiments of the disclosed wound treatment products, the following terms are explained. In this document, the term "wound treatment product" refers to a multi-layered, integrated wound dressing. The term "wound dressing" refers to an interactive product (e.g., bandage, covering, compression material, protective layer) that can address wounds.

[0049] The term "skin substitute" refers to a group of elements or materials capable of temporarily or permanently closing a wound. In a preferred embodiment, the skin substitute may be a cell-free dermal matrix, such as a bioscaffold material.

[0050] The terms "cell-free," "decellularized," and "decellularized fish skin" as used herein refer to fish skin with a complex three-dimensional ECM interstitial structure remaining after a large number of cells and nucleic acid contents have been removed. In some embodiments, "decellularized fish skin" may include fish skin containing omega 3 polyunsaturated fatty acids (PUFAs) in addition to a complex three-dimensional ECM interstitial structure (without a large number of cells and nucleic acid contents).

[0051] As used herein, the term "extracellular matrix" or "ECM" refers to the noncellular tissue component present in fish skin that provides structural support for skin cells and performs various other important functions. The ECM described herein does not necessarily contain matrix material composed entirely of or reformed from extracted, purified, or isolated ECM components (such as collagen). However, in some embodiments, the ECM used as a skin substitute may contain matrix material composed entirely of or reformed from extracted, purified, or isolated ECM components (such as collagen).

[0052] The term “treatment” should be understood according to its commonly used dictionary definition. In a broad sense, “treatment” includes the provision of medical care components (i.e., bandages and dressings) and / or medications for a patient’s illness or injury. Those skilled in the art will understand that “treatment” can include the use of chemical, physical, or biological agents to protect something or impart specific properties to it. Therefore, “treatment” can refer to the medical care provided (i.e., in the form of a method or a series of prescribed actions) or to medications used to protect something or impart specific properties to something.

[0053] As used herein, the term "wound" is intended to refer broadly to tissue damage. Therefore, the term "wound" may include, for example, injuries that cause cuts, tears, and / or ruptures of the skin, such as lacerations, abrasions, cuts, punctures, avulsions, or other such injuries. Wounds can be of any size, shape, or magnitude. For example, a paper cut is a typical example of a relatively minor, small, straight cut, while a shockwave blast that causes a large laceration covering one or more body parts is a typical example of a more severe, relatively large wound. However, all of these examples fall within the scope of the term "wound" as used herein.

[0054] Furthermore, the term "wound" also includes damage to deep tissues, such as damage caused by traumatic injury. Therefore, the term "wound" is intended to encompass a combination of various types of wounds. For example, a traumatic amputation caused by an blast is often referred to as a wound, although it is a collection of many different lacerations, abrasions, avulsions, and puncture wounds. In addition, any deep tissue damage caused by the aforementioned blast can also be further included in the understanding of wound here.

[0055] The term "wound" is also intended to cover tissue damage caused by burns (e.g., thermal burns and / or chemical burns). Furthermore, the term "wound" is intended to cover injuries such as diabetic foot ulcers, venous leg ulcers, surgical injuries, pressure ulcers, and other causes.

[0056] The term "biocompatibility" refers to the fact that a material is essentially non-toxic in the in vivo environment in which it is intended to be used and is not substantially rejected by the patient's physiological system (i.e., non-antigenic).

[0057] The term "polymer contact layer" refers to a polymer coating that is impermeable to fluids and bacteria, but allows moisture to permeate through the coating.

[0058] The term "elastomeric layer" refers to a soft, medical-grade, gel-like layer designed to act as a low-adhesion contact layer in contact with the skin surrounding a wound. In a preferred embodiment, the elastomeric layer comprises silicone.

[0059] The term "open structure" refers to a hole, slit, slot, pore, or opening that extends through the thickness of the layer.

[0060] Unless otherwise stated, figures used in the specification and claims to represent quantities, components, distances, or other measurements should be understood to be modified, where appropriate, by the term “about” or its synonyms. When the terms “about,” “approximately,” “substantially,” or similar terms are used in conjunction with the stated quantities, values, or conditions, they can be understood to refer to a quantity, value, or condition that deviates from the stated quantity, value, or condition by less than 20%, less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01%. At least (and not at all, attempting to limit the application of the doctrine of equivalents within the scope of the claims), each numerical parameter should be interpreted according to the number of significant figures stated and using conventional rounding methods.

[0061] It should also be noted that, unless the context explicitly defines otherwise, the singular forms “a,” “an,” and “the” used in this specification and the appended claims do not exclude plural references. Therefore, for example, embodiments referring to a singular reference (e.g., “component”) may also include two or more such references.

[0062] Although the present invention has been described with reference to specific embodiments, it should be understood that these embodiments are merely for illustrating the principles and applications of the invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed wound dressings (i.e., wound dressings 100, 200, 300, 400) without departing from the scope of the invention. Therefore, it is intended that the principles and aspects of each embodiment be adaptable to each other where feasible. Detailed Implementation

[0063] Figure 1 A wound treatment product 100 according to the present invention is shown. In one exemplary embodiment, the wound treatment product 100 is a wound dressing comprising an intact skin substitute 102 for supporting tissue regeneration of the wound, and an integral, adhesive polymer contact layer 104 that helps protect the wound surface and hold the skin substitute 102 in place. The wound treatment product also includes a release liner 110. The wound treatment product 100 is suitable for treating the following types of wounds: partial-thickness and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, and traumatic wounds (e.g., abrasions, lacerations, partial burns, skin tears), as well as surgical wounds (e.g., donor / graft sites, post-Moll's procedure wounds, post-laser procedure wounds, foot wounds, wound dehiscence).

[0064] Wound Management Product 100 is suitable for use in the clinic. Its one-piece design allows for faster treatment and operation, saving users time. Wound Management Product 100 can be completely immersed in saline solution and requires no additional materials or devices for fixation at the wound site. Wound Management Product 100 provides an efficient and simplified option for wound care management. The unique layers and interlayer relationships of Wound Management Product 100 are described in detail below.

[0065] Skin substitutes 102 can be broadly considered as a group of components or materials capable of temporarily or permanently closing wounds. Skin substitutes 102 can be broadly classified into biological skin substitutes, synthetic skin substitutes, or hybrid skin substitutes containing both biological and synthetic components. Biological skin substitutes typically possess a more complete extracellular matrix structure, while synthetic skin substitutes can be synthesized as needed and tailored for specific purposes. Both biological and synthetic skin substitutes have their own advantages and disadvantages.

[0066] Due to the presence of the basement membrane, biological skin substitutes can construct a more natural new dermis and exhibit excellent re-epithelialization properties. Synthetic skin substitutes can be chemically synthesized and offer greater control over the scaffold components. Synthetic skin substitutes include synthetic biological layers, such as those comprising a synthetic collagen matrix or a protein-based matrix, or a combination of collagen or protein-based components with silicone components. Hybrid skin substitutes can be partially synthesized or formed from living cells and partially chemically synthesized.

[0067] Whether biological, synthetic, or hybrid skin substitutes are used, the purpose of using skin substitutes is to achieve effective, timely, and scarless wound healing, and to restore the skin to its pre-wound function as much as possible. Examples of such skin substitutes are described in U.S. Patent Application US 2022 / 0313873, filed March 24, 2022, which is incorporated herein by reference in its entirety.

[0068] Figure 2An exemplary skin substitute 102 according to the present invention is shown. In one embodiment, the skin substitute 102 is a complete acellular fish skin product, such as the product described in U.S. Patent 8,613,957. The acellular fish skin product is a complete scaffold capable of supporting the ingrowth of endothelial cells and / or epithelial cells. Due to its porous scaffold design, the acellular fish skin product enables 3D cell ingrowth. The acellular fish skin product is biocompatible and can therefore be integrated by the host at the wound site. In one embodiment, the skin substitute 102 is made from lightly processed skin of wild-caught Atlantic cod from Iceland. Fish skin is structurally similar to human skin, both having three basic layers including the epidermis, dermis, and subcutaneous tissue, and containing proteins, lipids, fatty acids, and other bioactive compounds homologous to human skin.

[0069] The fish skin embodiment of skin substitute 102 is preferably treated with one or more decellularized solutions to remove cellular components (including antigenic components) from the fish skin with minimal or no damage to the mechanical and structural integrity and biological activity of the naturally occurring extracellular matrix. The term "extracellular matrix" or "ECM" refers to the noncellular tissue component in fish skin that provides structural support for skin cells and performs various other important functions. ECM products mentioned herein do not include matrix materials composed entirely of extracted, purified, or isolated ECM components (such as collagen) or reformulated from them. According to one or more embodiments, the ECM product may be granular, sheet-like, or mesh-like.

[0070] The terms "cell-free," "decellularized," and "decellularized fish skin" used in this article refer to fish skin with a complex three-dimensional ECM interstitial structure left after a large number of cells and nucleic acid contents have been removed. Decellularization disrupts cell membranes and releases cellular contents. Decellularization can involve one or more physical treatments, one or more chemical treatments, one or more enzymatic treatments, or any combination thereof. This material is cost-effective, can be converted into a usable resource, and retains key biological characteristics comparable to other animal-derived skin technologies.

[0071] In some embodiments, decellularization (and other optional processing steps) does not remove all naturally occurring lipids from the lipid layer of the fish skin. Therefore, the scaffold material can contain one or more lipids from the fish skin, particularly lipids from the lipid layer. The lipids in the scaffold material can, for example, include fatty acyl groups (i.e., fatty acids, their conjugates, and derivatives). In some embodiments, the fatty acids include omega-3 fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (which are abundant in fish oil). Omega-3 fatty acids can enhance tissue regeneration and enhance the fish skin's ability to act as a bacterial barrier. Embodiments of fish skin for skin substitute 102 also have the unique advantage of avoiding cultural and / or religious barriers to clinician and patient acceptance. Furthermore, embodiments of fish skin for skin substitute 102 are less allergenic, avoid the risk of disease transmission, and do not require multilayer transplantation. In one embodiment, skin substitute 102 may be selected from the group comprising cowhide, pigskin, biosynthetic skin, and fish skin.

[0072] Figure 2 The skin substitute 102 has an opening structure 112 to facilitate the drainage of wound exudate during the healing process. The opening structure 112 may be designed as a slot, pore, or other opening to allow proper drainage through the thickness T1 of the skin substitute 102. Setting the opening structure 112 as a slot allows wound exudate to flow through the skin substitute 102 and increases the flexibility of the dried wound treatment product 100, while also reducing product waste and increasing the contact area between the skin substitute 102 and the wound site.

[0073] In one embodiment, the skin substitute 102 includes 1 to 10 linear openings 112, preferably 5 linear openings. However, those skilled in the art will understand that the design of the openings can vary depending on the size of the skin substitute or the application of the wound treatment product 100. For example, the openings can also be curved or circular.

[0074] In one embodiment, the skin substitute 102 is disc-shaped and has a wound contact surface 114, the surface area A1 of which is between 2 square centimeters and 10 square centimeters. The surface area A1 of the skin substitute 102 can also be less than 2 square centimeters or greater than 10 square centimeters; however, preferably, the surface area A1 of the skin substitute 102 is approximately equal to the wound size. The size of the skin substitute 102 is not specifically limited and can be manufactured, supplied, or tailored to fit the size and shape of the wound to be treated. Furthermore, the skin substitute 102 can be constructed as a mesh-like decellularized fish skin, or it can be granulated, pulverized, or processed into various sizes and shapes (square, rectangle, pentagon, hexagon, etc.).

[0075] Figure 3An exemplary polymer contact layer 104 according to the present invention is shown. In one embodiment, the polymer contact layer 104 comprises a pre-formed hydrophobic membrane 108 coated with an elastomeric layer 106. The polymer contact layer 104 is a non-adhesive or low-adhesive wound contact layer. The polymer contact layer 104 can be painlessly removed from the skin. In a preferred embodiment, the polymer contact layer 104 makes direct, non-adhesive contact with the wound and exhibits low adhesion to the skin surrounding the wound. The polymer contact layer 104 is configured to remain in place (e.g., fixed in the same location as initially applied to the skin) for up to fourteen days. In one embodiment, this period can be up to fourteen days (the product-approved lifespan), or longer than the time allowed for cell ingrowth and tissue regeneration at the wound site.

[0076] In one embodiment, the polymer contact layer 104 includes a plurality of pores 118. The pores 118 extend through the hydrophobic membrane 108 and the elastomeric layer 106. In a preferred embodiment, the pores 118 extending through the hydrophobic membrane 108 correspond to or are aligned with the pores 118 extending through the elastomeric layer. Therefore, the pores 118 can continuously penetrate the polymer contact layer 104.

[0077] In one embodiment, the pores 118 are configured as circular holes to allow wound exudate to flow freely from the wound site through the polymer contact layer 104. In one embodiment, the diameter of the pores is between 0.5 mm and 5 mm, preferably between 1 mm and 4 mm.

[0078] In one embodiment, the polymer contact layer 104 has a predetermined porosity to allow wound exudate to pass through the thickness of the polymer contact layer 104. The predetermined porosity defines the distribution of pores 118 over the surface area of ​​the polymer contact layer 104. The distribution of pores 118 is configured to adequately facilitate the drainage of wound exudate while allowing sufficient contact between the surface area of ​​the elastomer layer and the skin to maintain gentle adhesion.

[0079] The distribution or porosity of pores 118 on the surface area of ​​the elastomer layer 106 is between 5% and 40%, preferably between 10% and 35%. In a preferred embodiment, the pore distribution is less than 25%, for example, about 17%. Preferably, the distribution of pores 118 on the surface area of ​​the polymer contact layer 104 should have sufficient porosity without impairing the sheet-like properties of the skin substitute 102.

[0080] In one embodiment, the polymer contact layer 104 includes a central portion 120 on the elastomeric layer 106, configured to directly bond with the silicone contact surface 116 of the skin substitute 102. The peripheral portion of the polymer contact layer 104 outside the central portion 120 is defined as an edge portion 122, configured to directly bond with the skin surrounding the wound. The surface area A2 of the elastomeric layer 106 is substantially equal to the surface area A3 of the hydrophobic membrane 108.

[0081] In one embodiment, the polymer contact layer 104 is disc-shaped, wherein the surface areas A2 and A3 of the elastomeric layer 106 and the hydrophobic membrane 108 are between 4 square centimeters and 20 square centimeters. Surface areas A2 and A3 may also be less than 4 square centimeters or greater than 20 square centimeters. Preferably, the ratio of surface areas A2 and A3 to the surface area A1 of the skin substitute 102 is 2:1, 3:1, 3:2, 4:1, 4:3, 5:1, 5:2, 5:3, or 5:4. Those skilled in the art will understand that the ratio of surface areas A2 and A3 to surface area A1 can be varied depending on the application; however, surface area A2 should be sufficiently larger than and adequately cover surface area A1 to allow the polymer contact layer 104 to remain in place and in contact with the skin around the wound for the desired duration.

[0082] In one embodiment, the elastomeric layer 106 has low adhesion between 0.015 and 0.85 N / cm, preferably between 0.035 and 0.8 N / cm. The elastomeric layer 106 is a hydrophobic, water-impermeable layer that combines with the hydrophobic membrane 108 to form an integral polymer contact layer 104. This is advantageous for skin substitutes 102 that require hydration before use. Therefore, the wound treatment product 100 can be aseptically processed and rehydrated (or rehydrated) by immersion in a sterile saline solution before application to the wound without losing its low adhesion. The elastomeric layer 106 is superior to other adhesives and polymers because it prevents microbial growth and dermatitis.

[0083] Furthermore, the biocompatibility of the elastomer layer 106 is characterized by low thermal conductivity, low chemical reactivity, and low toxicity. In one embodiment, the elastomer layer 106 is preferably transparent to allow observation of the skin surrounding the wound and the passage of exudate through the corresponding pores 118. In another embodiment, the elastomer layer 106 may be colored or skin-colored to provide an aesthetically pleasing appearance or to provide a prominent indication of the wound site. In yet another embodiment, the elastomer layer 106 includes both transparent and colored or skin-colored portions to balance observation of the wound site with aesthetic appeal.

[0084] The hydrophobic membrane 108 is an elastic, water-impermeable barrier bonded to the elastomer layer 106. The hydrophobic membrane 108 enhances the performance of the elastomer layer 106 to improve durability and extend the service life or service period of the wound treatment product 100. The hydrophobic membrane 108 is permeable to gases and water vapor but impermeable to proteins and bacteria. The outer surface 123 of the hydrophobic membrane 108 (i.e., the side of the hydrophobic membrane 108 not bonded to the elastomer layer 106) serves as a protective layer for the polymer contact layer 104.

[0085] The hydrophobic membrane 108 can withstand mechanical abrasion, reduce infection rates, and maintain ideal wound moisture. In one embodiment, the hydrophobic membrane 108 is preferably transparent to allow observation of the skin around the wound and the passage of exudate through the corresponding pores 118. In another embodiment, the hydrophobic membrane 108 is colored or skin-colored to provide an aesthetically pleasing appearance or to provide a prominent indication of the wound site. In yet another embodiment, the hydrophobic membrane 108 includes both transparent and colored or skin-colored portions to balance observation of the wound site with aesthetic appeal.

[0086] The hydrophobic membrane 108 comprises a biocompatible polymer. Any polymeric material suitable for use as a dressing material can be used as a biocompatible polymer without limitation, and can be suitably selected by those skilled in the art. Biocompatible polymers may include, for example, one or more of the following: polyvinyl alcohol, polyurethane, polyethylene, polyethylene oxide, low-density polyethylene, polyacrylic acid, polyoxyethylene, polytetrafluoroethylene, polypropylene, polyethylene terephthalate, polyamide, polyacrylonitrile, polyester, polyvinyl chloride, polyvinylidene fluoride, polysiloxane (silicone rubber), polyglycolic acid, polylactic acid, polymethacrylic acid, polyacrylamide, polysaccharides, polyvinylpyrrolidone, organosilicon, alginate, sodium alginate, cellulose, pectin, chitosan, chitin, gelatin, collagen, fibroin, hyaluronic acid, natural rubber, synthetic rubber, or combinations thereof. In a preferred embodiment, the hydrophobic membrane 108 comprises polyurethane.

[0087] Figure 4 A wound treatment product 100 is shown, comprising a skin substitute 102 and a polymer contact layer 104. The skin substitute 102 is in direct contact with the elastomeric layer 106 of the polymer contact layer 104, wherein the boundary of the skin substitute 102 is surrounded by the boundary of the polymer contact layer 104. Specifically, the skin substitute 102 is disposed within the edge portion 122 of the polymer contact layer 104.

[0088] In one embodiment, the area of ​​the open structure 112 distributed on the surface area A1 of the skin substitute 102 is between 0% and 49% compared to the area of ​​the pores 118 distributed on the surface area A2 of the elastomeric layer 106. The pores 118 through the hydrophobic membrane 108 and the elastomeric layer 106 allow sterile salt solutions to pass through the thickness of the polymer contact layer 104 and wet the skin substitute 102 without compromising the low adhesiveness of the elastomeric layer 106.

[0089] Figure 5 An exemplary release liner 110 that can be used with the disclosed wound treatment product 100 is shown. The release liner 110 serves as a protective layer before application, disposed on and in direct contact with the elastomer layer 106 and the skin substitute 102, thereby protecting and shielding them from contamination before application to the wound. The release liner 110 may be made of a material and disposed on the wound treatment product 100 so that it can be easily removed, for example, by a medical professional, before applying the wound treatment product 100 to the wound. That is, the release liner 110 is non-adhesive to the skin substitute 102.

[0090] In one embodiment, the release liner 110 includes at least one tear tab to facilitate removal of the release liner 110 from the elastomer layer 106 and the skin substitute 102. In one embodiment, the surface area A4 of the release liner 110 is substantially equal to or slightly larger than the surface area of ​​the elastomer layer 106. This provides adequate protection and coverage for the skin substitute 102 and the elastomer layer 106.

[0091] In one embodiment, release liner 110 comprises a polyolefin film material. Polyolefins are preferred because they use less material and are recyclable, and are generally considered more environmentally friendly than other films. Other polymers suitable for release liner 110 include, but are not limited to: low-density polyethylene, polyvinyl alcohol, nylon, polyester, polystyrene, polymethylpentene, polyoxymethylene, copolymers thereof, and mixtures thereof. The material of release liner 110 is chosen such that it can be removed from the skin substitute 102 and the elastomer layer 106 without compromising the material properties of the wound treatment product 100.

[0092] When the skin substitute 102 and the elastomer layer 106 are immersed in a sterile saline solution, the release liner 110 remains in contact with the skin substitute 102 and the elastomer layer 106. Other suitable materials may also be used for the release liner 110, and the material of the release liner 110 should be selected so as not to reduce the adhesion of the elastomer layer 106 when the release liner 110 is removed from the wound treatment product 100. In one embodiment, the release liner 110 is biodegradable.

[0093] In one embodiment, the release liner 110 includes a first sheet 124 and a second sheet 126 that overlap each other to form a portion covering a surface area A4 of the release liner 110. An overlapping region 128 is formed by the portion where the second sheet 126 overlaps with the first sheet 124. The overlapping region 128 allows the user to easily grasp and peel the first sheet 124 and the second sheet 126 from the skin substitute 102 and the elastomer layer 106 before the wound treatment product 100 is applied to the wound. In one embodiment, the first sheet 124 is substantially the same size and shape as the second sheet 126. In another embodiment, the first sheet 124 is larger in size and shape than the second sheet 126, wherein the overlapping region 128 is located at a smaller arc segment or closer to the outer peripheral edge of the release liner 110 (depending on the shape).

[0094] In a preferred embodiment, regardless of the presence of overlapping regions 128, the total area coverage provided by the first sheet 124 and the second sheet 126 of the release liner 110 is greater than or equal to the surface area of ​​the elastomer layer 106, thereby providing adequate protection for the skin substitute 102 and the elastomer layer 106. In one embodiment, the release liner 110 is provided with cuts (e.g., non-overlapping regions) that divide the release liner 110 into the first sheet 124 and the second sheet 126, which can be removed by a user using aseptic techniques (i.e., forceps, tweezers, clips). Advantageously, the skin substitute 102 located between the polymer contact layer 104 and the release liner 110 is configured to be immersed in a saline solution along with the polymer contact layer 104 and the release liner 110 to hydrate the skin substitute 102.

[0095] Figure 6 A cross-sectional view of one embodiment of a wound treatment product 100 is shown. The skin substitute 102 has a first thickness T1. Generally, the first thickness is about 0.1 to 4.0 mm thick (i.e., in cross-section), for example, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, or 3.5 mm thick. The thickness can be selected based on a number of factors, including the species of fish used as raw material, processing, freeze-drying, and rehydration, as detailed in U.S. Patent 8,613,957. In one embodiment, the skin substitute 102 having the first thickness T1 may be multilayered. In one embodiment, the first thickness T1 is uniform across the entire surface area A1 of the skin substitute 102. In another embodiment, the first thickness may taper (decreasing) at the edges defining the surface area A1 of the skin substitute 102.

[0096] The polymer contact layer 104 also includes a second thickness T2 characterizing the basis weight thickness of the elastomeric layer 106, and a third thickness T3 characterizing the thickness of the hydrophobic film 108. The total thickness of the polymer contact layer 104 (e.g., the sum of the cross-sections of the second thickness T2 and the third thickness T3) is preferably greater than 0.2 mm. Generally, the second thickness T2 is between about 50 and 200 gsm, for example, 100, 110, 120, 130, 140, 150, 160, 170, 180, or 190 gsm thick. “GSM” (or grams per square meter) is a unit for measuring the thickness of materials such as paper and fabrics. The basis weight thickness T2 is based on the weight of the elastomeric (e.g., silicone) gel used in the elastomeric layer 106 and the surface area A2 of the elastomeric layer 106. In one embodiment, the second thickness T2 is uniform across the entire surface area A2 of the elastomeric layer 106. In another embodiment, the second thickness T2 decreases at the edge defining the surface area A2 of the elastomeric layer 106. In one embodiment, the second thickness T2 decreases at the central portion 120 of the polymer contact layer 104 to receive and partially accommodate the skin substitute 102 within a groove.

[0097] Generally, the third thickness T3 is between 25 and 100 µm, for example, 50, 60, 70, 80, or 90 µm thick. The third thickness T3 is chosen such that the hydrophobic membrane 108 has sufficient flexibility and elasticity to conform to the skin surrounding the wound site and exhibits stability and strong resistance to moisture and organic solvents. In one embodiment, the third thickness T3 is uniform across the entire surface area A2 of the elastomer layer 106. In another embodiment, the third thickness T3 decreases at the edges defining the surface area A3 of the hydrophobic membrane 108.

[0098] Release liner 110 includes a fourth thickness T4 characterizing the basis weight thickness of the protective layer before application. In embodiments where release liner 110 includes a first sheet 124 and a second sheet 126, the thickness of the cross-section of the first sheet 124 and the second sheet 126 is equal to the fourth thickness T4. Generally, the fourth thickness T4 is between about 50 and 100 gsm, for example, 55, 65, 75, 85, or 95 gsm. The basis weight thickness T4 is based on the weight of the material used for release liner 110 and the surface area A4 of release liner 110. In one embodiment, the fourth thickness T4 is uniform across the entire surface area A4 of release liner 110. In one embodiment, the fourth thickness T4 increases at an overlap region 128 where the thicknesses of the first sheet 124 and the second sheet 126 overlap.

[0099] Figure 7 and Figure 8 A cross-sectional view is shown of the wound treatment product 100 applied to and removed therefrom. (See attached image.) Figure 7 As shown, a skin substitute 102 is placed on the wound 101. The skin substitute 102 is aligned with the central portion 120 of the polymer contact layer 104 and substantially conforms to or covers the wound 101 to achieve good healing. The skin substitute 102 is in direct contact with the elastomer layer 106 and has low adhesion. The polymer contact layer 104 is positioned such that the edge portions 122 of the polymer contact layer 104 can gently adhere to the skin 103 surrounding the wound 101.

[0100] The polymer contact layer 104 serves as an additional wound covering layer to protect the skin substitute 102, and the elastomeric layer 106 serves as a low-adhesion contact layer that contacts the skin 103 surrounding the wound 101. The elastomeric layer 106 has sufficient adhesiveness to hold the skin substitute 102 in place (e.g., aligned with the central portion 120) before and during application of the wound treatment product 100. Sufficient adhesiveness is defined as an adhesive force between 0.015 and 0.85 N / cm, preferably between 0.035 and 0.8 N / cm.

[0101] Figure 8 The removal of the polymer contact layer 104 (including the elastomer layer 106 and the hydrophobic membrane 108) at wound 101 is shown. The edge portion 122 of the polymer contact layer 104 does not interfere with wound 101 and can be easily and painlessly removed from skin 103. During removal after healing has begun, the polymer contact layer 104 can be removed from skin 103 while the skin substitute 102 remains in contact with the healing wound 101.

[0102] In embodiments using acellular dermal matrix (e.g., decellularized fish skin) as skin substitute 102, skin substitute 102 can support cell ingrowth 132 of endothelial cells and / or epithelial cells. As described above, the decellularized fish skin product enables 3D cell ingrowth 132 due to its porous scaffold design. In addition to the convenient drainage of wound exudate through pores 118, the polymer contact layer 104 provides stronger protective support and promotes healing to form regenerative tissue 130 at the wound 101.

[0103] In another embodiment, a wound management product 200 is provided to support wound healing in stoma applications, wherein an incision is made in the patient's skin to create a surgically formed opening (stomach). In such applications, it is advantageous to structurally reinforce the opening at the wound site and to support the inserted percutaneous device (e.g., a tracheostomy tube). It is understood that the wound management product 200 (such as...) Figure 9 (As shown) is an alternative embodiment of wound treatment product 100, wherein all aspects of wound treatment product 100 are applicable to wound treatment product 200. Figure 9A wound treatment product 200 of the present invention is shown, comprising a skin substitute 202 and a polymer contact layer 204. The polymer contact layer 204 includes an elastomeric layer 206 for direct contact with the skin around the wound or stoma site, and a hydrophobic membrane 208 for providing protection to the skin substitute 202 and serving as an additional wound covering layer.

[0104] The polymer contact layer 204 preferably includes pores 218 to facilitate proper drainage of wound exudate. The wound treatment product 200 includes openings 220 extending through the skin substitute 202 and each layer of the polymer contact layer 204. The openings 220 allow percutaneous device introduction into the stoma site while still allowing the skin substitute 202 around the wound site to promote healing.

[0105] In one embodiment, the skin substitute 202 includes one or more openings 212 to allow proper drainage of exudate from the wound during healing. In one embodiment, the wound treatment product 200 includes an incision 224 extending from the opening 220 to the outer edge of the polymer contact layer 204. The incision 224 allows the wound treatment product 200 to be flexibly positioned around an existing percutaneous device inserted at the stoma site.

[0106] Figure 10 An alternative embodiment is shown, combining wound treatment product 300 with a secondary dressing (e.g., a bandage). It is understood that... Figure 10 The wound treatment product 300 shown is an alternative embodiment of the wound treatment product 100, wherein various aspects of the wound treatment product 100 are applicable to the wound treatment product 300. The wound treatment product 300 includes a skin substitute 302 integrally bonded to a polymer contact layer 304. The polymer contact layer 304 preferably includes an elastomeric layer 306 in direct contact with the skin substitute 302, and a hydrophobic membrane 308 for protecting the skin substitute 302 and serving as an additional wound covering layer.

[0107] In one embodiment, the surface area A1 of the skin substitute 302 is equal to the surface areas A2 and A3 of the elastomeric layer 306 and the hydrophobic membrane 308. That is, the layers in the skin substitute 302 and the polymer contact layer 304 have the same shape and size. The polymer contact layer 304 advantageously supports the wound treatment product 300 in maintaining moisture at the wound site. In one embodiment, the skin substitute 302 includes an open-cell structure, and the polymer contact layer 304 includes pores to allow proper drainage of exudate from the wound during the healing process.

[0108] Figure 11 An embodiment of a wound treatment product 400 comprising a skin substitute 402, a polymer contact layer 404, and a release liner 410 is shown. It should be understood that, in conjunction with... Figure 11The described wound treatment product 400 is an alternative embodiment of wound treatment product 100, and all aspects of wound treatment product 100 can be applied to wound treatment product 400. For example... Figure 12 As shown, the skin substitute 402 includes a helical perforated structure 412 having a helical configuration extending through the thickness of the skin substitute 402. In one embodiment, the perforated structure 412 is perforated to allow guided separation of the skin substitute 402 in a helical pattern. The perforated structure 412 also facilitates the drainage of wound exudate during the healing process. The perforated structure 412 is configured as a helical slot, allowing wound exudate to flow through the skin substitute 402, thereby allowing for faster sizing and increasing the flexibility of the dried wound treatment product 400, while also reducing product waste and increasing the contact area between the skin substitute 402 and the wound site.

[0109] Figure 13 An exemplary helical configuration of the opening structure 412 of the skin substitute 402 is shown. The skin substitute 402 can be conveniently adjusted from a first size or diameter D1 to a second size or diameter D2 by unfolding and cutting (or tearing) it. The helical configuration of the opening structure 412 allows for stable and controlled trimming of the skin substitute 402 to accommodate various wound sizes. The opening structure 412 can be configured as an Archimedean spiral, a logarithmic spiral, a parabolic spiral, or a Dürer spiral.

[0110] In one embodiment, the skin substitute 402 may have a first diameter D1 of 30 mm, wherein the opening structure 412 has a 2 mm outer spiral segment to allow the skin substitute to be trimmed to a second diameter D2. The second diameter D2 may be a minimum diameter, such as 15 mm. The spiral configuration of the opening structure 412 may be marked to indicate to the user the approximate diameter and / or where the skin substitute is cut. Advantageously, the spiral opening structure 412 can reduce area loss and provide greater flexibility in the customization of the skin substitute 402.

[0111] Figure 14 An exemplary method of manufacturing embodiments of the disclosed wound treatment products 100, 200, 300, and 400 is shown. In an initial step S1, fresh fish skin is obtained. The fish used to obtain the skin is preferably wild-caught North Atlantic cod, as there is known no risk of viral transmission between North Atlantic cod and humans. Next, in step S2, the fish skin is decellularized, and in step S3, it is freeze-dried, using a method similar to that detailed in U.S. Patent 8,613,957 to form a skin substitute.

[0112] Subsequently, in step S4, the skin substitute is cut to a predetermined size. The predetermined size is set to correspond to a pair of polymer contact layers such that the pair of polymer contact layers can accommodate the corresponding fish skin substitute. The polymer contact layers are pre-cut and manufactured to include a hydrophobic membrane, an elastomer layer, and a release liner. Subsequently, in step S5, the skin substitute is processed and assembled between the release liner of the polymer contact layers and the elastomer layer. In a preferred embodiment, an assembly tool can partially peel the release liner from the elastomer layer. The assembly tool places the skin substitute in an acceptable position where it is in direct contact with the elastomer layer and the release liner. The assembly tool then covers the release liner, bringing the skin substitute tightly against the elastomer layer, thereby forming a one-piece wound treatment product.

[0113] After assembling the integrated wound care product, it can be packaged in step S6 within a package made of synthetic flash-evaporated high-density polyethylene fiber (e.g., Tyvek) or other suitable packaging material. The final step in manufacturing the wound care product includes sterilization in step S7 using an appropriate sterilization technique, such as sterilization with ethylene oxide (EtO) gas.

[0114] Figure 15 Exemplary assembly methods for embodiments of the disclosed wound treatment products 100, 200, 300, and 400 are shown. After removing a pre-cut polymer contact layer 104 from its previously manufactured packaging, the polymer contact layer 104, bonded to a release liner 110, is placed into an assembly tool 134. The assembly tool 134 includes a sliding clamp 136 for holding the polymer contact layer 104 during assembly. In a first assembly step S5-1, the assembly tool 134 is engaged with the release liner 110 by sliding the sliding clamp 136 onto the overlapping second sheet 126 of the release liner 110, thereby holding the polymer contact layer 104 in place.

[0115] The top side of the overlapping second sheet 126 of the release liner 110 is located on one side of the assembly tool 134 containing the sliding clamp 136. Next, in the second assembly step S5-2, the overlapping second sheet 126 of the release liner 110 is pulled back until the receiving skin substitute 102 side of the polymer contact layer 104 is exposed. In this step, the release liner 110 is pressed against the sliding clamp 136. In the third assembly step S5-3, the polymer contact layer 104 is held in place by the sliding clamp 136. Simultaneously, the skin substitute 102 is inserted to engage with the elastomeric layer 106 of the polymer contact layer 104.

[0116] Preferably, the skin substitute 102 is attached to the elastomeric layer 106 using the centering element 138 of the assembly tool 134. In one embodiment, the centering element 138 is a circular element corresponding to the center of the wound treatment product 100. Sufficient pressure is applied to attach the skin substitute 102 to the elastomeric layer 106 so that the elastomeric layer 106 adheres to the skin substitute 102 without damaging the skin substitute 102. Subsequently, the sliding clamp 136 can be removed from the polymer contact layer 104 to detach the wound treatment product 100.

[0117] During step S5-4, another first sheet 124 of the release liner 110 is then removed from the polymer contact layer 104 so that the remaining portion of the skin substitute 102 can bond to the elastomer layer 106. Preferably, the elastomer layer 106 is not under tension (e.g., stretched) when the skin substitute 102 is placed on it. The first sheet 124 and the second sheet 126 of the release liner 110 are then rearranged back to their original overlapping positions, with the second sheet 126 overlapping the first sheet 124. In step S5-5, sufficient force is applied around the edge portion 122 of the polymer contact layer 104 to strengthen the adhesive bond between the release liner 110 and the elastomer layer 106. The assembled wound treatment product 100 can then be placed back onto the assembly tool 134 to confirm in step S5-6 that the skin substitute 102 is correctly positioned. The centering element 138 of the assembly tool 134 is used to confirm whether the wound treatment product 100 is qualified.

[0118] It is understood that the above embodiments of the present invention can take various shapes, sizes and constructions without departing from the scope of the present invention.

[0119] It is understood that the above embodiments are illustrative in nature and can be modified by those skilled in the art. Therefore, the present invention should not be considered as limited to the embodiments disclosed herein, but should be defined only by the appended claims.

Claims

1. A wound dressing (100), comprising: Skin substitute (102); A polymer contact layer (104), the polymer contact layer comprising an elastomer layer (106) bonded to a hydrophobic membrane (108); and Release liner (110) is disposed on and in contact with the skin substitute (102) and the polymer contact layer (104); The skin substitute (102) is located between the polymer contact layer (104) and the release liner (110); The skin substitute (102) is configured to be immersed in a salt solution together with the polymer contact layer (104) and the release liner (110) for hydration.

2. The wound dressing (100) according to claim 1, characterized in that, The skin substitute (102) is acellular dermal matrix, including acellular fish skin.

3. The wound dressing (100) according to claim 2, characterized in that, The skin substitute (102) comprises lipids from the lipid layer of the decellularized fish skin.

4. The wound dressing (100) according to claim 1, characterized in that, The skin substitute (102) comprises an extracellular matrix product in a three-dimensional form, in the form of granules, sheets or mesh.

5. The wound dressing (100) according to claim 1, characterized in that, The skin substitute (102) is in direct contact with the elastomeric layer (106) of the polymer contact layer (104).

6. The wound dressing (100) according to claim 1, characterized in that, The skin substitute (102) includes at least one open structure (112) extending through the thickness of the skin substitute.

7. The wound dressing (100) according to claim 6, characterized in that, The perforation structure (112, 412) is formed in a spiral shape.

8. The wound dressing (100) according to claim 1, characterized in that, The elastomeric layer (106) has sufficient adhesiveness to eliminate the need for an adhesive between the elastomeric layer (106) and the skin substitute (102).

9. The wound dressing (100) according to claim 1, characterized in that, The elastomeric layer (106) comprises silicone material, and the hydrophobic membrane (108) comprises polyurethane material.

10. The wound dressing (100) according to claim 1, characterized in that, The polymer contact layer (104) has distributed pores (118) that define a predetermined porosity over the surface area of ​​the polymer contact layer (104).

11. The wound dressing (100) according to claim 1, characterized in that, The distribution area of ​​the pores (118) is less than 25% of the surface area of ​​the polymer contact layer.

12. An integrated wound care product (100), comprising: A skin substitute (102) in direct contact with a polymer contact layer (104), the polymer contact layer (104) comprising a hydrophobic membrane (108) and an elastomer layer (106) in direct contact with the skin substitute (102); The elastomeric layer (106) has sufficient adhesiveness to eliminate the need for an adhesive between the elastomeric layer (106) and the skin substitute (102); The integrated wound treatment product (100) is configured to be applied to a wound (101) so that the skin substitute (102) comes into contact with the wound (101), and the polymer contact layer (104) covers the skin substitute (102) and also adheres to the skin (103) surrounding the wound (101). Wherein, after the skin substitute (102) is applied to the wound (101), and after a period of time has been allowed for cell ingrowth and tissue regeneration at the wound (101) where the skin substitute (102) is provided, the polymer contact layer (104) is configured to be separable from the skin substitute (102).

13. The wound treatment product (100) according to claim 12, characterized in that, The polymer contact layer (104) has a predetermined porosity to allow wound exudate to pass through.

14. The wound treatment product (100) according to claim 12, characterized in that, The skin substitute (102) is provided with an open structure.

15. The wound treatment product (100) according to claim 12, characterized in that, The skin substitute (102) is selected from the group consisting of cowhide, pigskin, biosynthetic skin and fish skin.

16. The wound treatment product (100) according to claim 12, characterized in that, The skin substitute (102) is acellular dermal matrix, including acellular extracellular matrix derived from fish skin.

17. The wound treatment product (100) according to claim 12, characterized in that, The integrated wound treatment product (100) includes a release liner (110) in contact with the skin substitute (102), the skin substitute (102) being disposed between the release liner (110) and the polymer contact layer (104).

18. A method for manufacturing an integrated wound care product (100), the method comprising: Obtain skin substitutes (102); The skin substitute (102) is cut to a predetermined size; as well as The skin substitute (102) is integrated with the polymer contact layer (104); The polymer contact layer (104) includes a hydrophobic film (108) coated with an elastomer layer (106). A release liner (110) is provided on the elastomeric layer (1066) of the polymer contact layer (104). The skin substitute (102) is located between the release liner (110) and the elastomer layer (106).

19. The method according to claim 18, characterized in that, The skin substitute (102) is fish skin, and the method further includes the following steps after obtaining the skin substitute (102): Decellularize the fish skin; and The decellularized fish skin was freeze-dried.

20. The method according to claim 19, characterized in that, It also includes sterilizing the integrated wound treatment product (100) using ethylene oxide gas.

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