Wound treatment products, kits, systems, and methods

Abstract

This invention provides a wound treatment product comprising a skin substitute, or a skin substitute connected to an absorbent core conforming to the shape of a wound bed. The wound treatment product is adapted to be applied to a wound surface such that the skin substitute contacts the wound bed, and the absorbent core conforms to the shape of the wound bed and fills the gaps in the wound bed.

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, a wound can become contaminated and infected by microorganisms. 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 ideally follow the natural principles of wound healing. That is, wound care products should ideally 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 proper healing.

[0004] Foam dressings (e.g., Lyofoam™, Allevyn™, Tielle™) provide sufficient absorbency and insulation, but their strong adhesion can cause dermatitis. A common problem in managing exudative wounds is maceration. Typically, the absorbent portion of a dressing is optimized for substantially vertical absorption, preventing the skin around the wound from contacting the exudate and thus avoiding maceration of this healthy but delicate skin. However, this characteristic limits the dressing's absorbency to the portion of the absorbent material directly above the wound. Protective ointments / skin conditioning creams (e.g., zinc oxide ointment) can be used on the surrounding skin to prevent maceration, but these creams often inhibit the dressing's stickiness and its ability to absorb exudate. Furthermore, gaps between the foam layer and the wound bed can lead to exudate buildup, promoting bacterial growth and increasing the risk of infection.

[0005] Biatain® Silicone Ag is a commercially available wound dressing that fills the gap between the wound bed and the dressing, reducing exudate buildup and creating an ideal environment for healing. Biatain® Silicone Ag has been shown to kill mature biofilms (Pseudomonas aeruginosa) and prevent biofilm formation. Silver (Ag) is a commonly used dressing in wound care due to its strong antibacterial activity. However, it can also hinder healing by exerting toxic effects on keratinocytes and fibroblasts. In addition to controversial effects (such as limitations in allergic reactions), the antibacterial silver nanoparticles in the dressing increase manufacturing costs.

[0006] 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.

[0007] U.S. Patent 8,613,957, issued December 24, 2013 (the entire contents of which are incorporated herein by reference), describes an exemplary scaffold material for wound care and / or 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 by the host. MariGen™ is a commercially available skin alternative made from lightly processed skin from wild-caught Atlantic cod sourced from Iceland. Fish skin is structurally similar to human skin, having three basic layers including the epidermis, dermis, and subcutaneous tissue, and 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.

[0008] The inventors of this invention have discovered that by integrating a bio-scaffold material with an absorbent core that conforms to the shape of the wound bed in a single unit, an improved wound care product can be provided that synergistically maintains moisture in the wound bed and promotes healing and tissue regeneration. Summary of the Invention

[0009] This invention proposes an improved, integrated wound care product for supporting wound tissue regeneration. The wound care product includes a bio-skin substitute integrally integrated with an absorbable core conforming to the shape of the wound bed.

[0010] The skin substitute is integrally bonded to or attached to the absorbent core. The integral bonding of the skin substitute to the absorbent core can include chemical bonding or the formation of discrete, segmented portions of the skin substitute within the absorbent core. The attachment of the skin substitute to the absorbent core can include adhesives, sutures, weaving, or the introduction of one or more layers with adhesive properties. This wound treatment product is suitable for application to a wound surface, such that the skin substitute contacts the wound bed, and the absorbent core fills the space in the wound bed.

[0011] The absorbent core includes a shape-compliant polymeric foam layer that conforms to the shape of the wound bed. The foam layer may include polyurethane or other compliant foam polymers that absorb wound exudate, conform to the shape of the wound bed, and reduce exudate buildup. In one embodiment, the absorbent core includes microcapillaries to facilitate vertical absorption of exudate. The term "vertical absorption" is defined as fluid absorption in a direction substantially perpendicular to the plane defined by the adjacent wound skin. The microcapillaries are preferably formed as channels including side pockets for containing absorbed fluid or retaining exudate. It is understood that, in the context of this invention, the terms "fluid," "moisture," and "exudate" are used interchangeably with respect to the wound and wound dressing. In one embodiment, microcapillaries are formed within an exudate-locking layer or receiving layer. In another embodiment, microcapillaries are formed in both the compliant foam layer and the receiving layer.

[0012] A backing layer can be provided in all embodiments of the dressing of the present invention. Preferably, the backing layer conforms to the body surface of an animal (including a human) and is waterproof but breathable. The backing layer, combined with the absorbent core, defines a storage layer or receiving layer between them when the dressing is in an swollen, water-containing state. The receiving layer helps to lock in absorbed exudate and prevent skin maceration. In embodiments where the backing layer does not allow liquid or exudate to pass through, the moisture in the absorbed exudate passes through the backing layer into the atmosphere in the form of vapor. In some embodiments, the backing layer includes an airtight material for use in conjunction with negative pressure wound therapy.

[0013] The wound treatment product includes a release liner for aseptic handling. The release liner protects the skin, the wound contact surface of the skin substitute, and any surrounding adhesive layers from contamination before application of the wound treatment product. In one embodiment, the release liner is transparent to allow visualization of the skin substitute. The release liner preferably includes at least one tear-off tab for easy separation from the skin substitute and silicone layer. The tear-off tab or slot is provided on the release liner to allow easy grasping and peeling from the wound treatment product before application. In one embodiment, the release liner includes a first layer and a second layer, wherein the second layer overlaps a portion of the first layer of the release liner. This portion of the first layer is thus positioned between the second layer and the decellularized dermal matrix.

[0014] In another preferred embodiment, a wound treatment product is provided, comprising: a skin substitute configured to be placed in contact with a wound; a contact membrane configured to contact the skin substitute and located between an absorbent core and the skin substitute; and a replaceable portion covering the contact membrane, the replaceable portion including an absorbent core configured to absorb wound exudate and a top membrane covering the absorbent core such that the absorbent core is disposed between the contact membrane and the top membrane, wherein the replaceable portion is separable from the contact membrane, thereby allowing the replaceable portion to be removed from the contact membrane without damaging or removing the skin substitute.

[0015] In one embodiment, the skin substitute is in direct contact with a polymeric contact layer comprising a mildly adhesive silicone. The wound treatment product is configured to be applied to a wound, allowing the skin substitute to contact the wound, with the polymeric contact layer disposed between the skin substitute and the absorbent core. The polymeric contact layer is integrally bonded to the absorbent core and removably attached to the skin substitute. In embodiments where the polymeric contact layer comprises or is composed of a silicone layer, the silicone layer advantageously contacts the skin graft material directly and is biocompatible with the skin. Furthermore, the polymeric contact layer prevents exudate from leaking out under pressure or being transported back to the wound bed. In one embodiment, the silicone layer provides a gentle adhesive bond to the skin substitute for proper fixation and painless separation after healing. The silicone layer has sufficient adhesiveness to eliminate the need for an adhesive between the silicone layer and the skin graft material. An exemplary polymeric contact layer is described in more detail in U.S. Provisional Application 63 / 541,661, entitled “Wound Dressing,” filed September 29, 2023, which is incorporated herein by reference in its entirety.

[0016] The polymer contact layer is adapted to facilitate easy detachment from the skin substitute after the skin graft material has been applied to the wound and after a period of time. In one embodiment, this period can be up to fourteen days, or a time window that allows cell ingrowth and tissue regeneration at the wound site. Preferably, the polymer contact layer has a predetermined porosity to allow wound exudate to flow through the thickness of the polymer contact layer to the absorbent core. The predetermined porosity defines the distribution of pores over the surface area of ​​the polymer contact layer. The pore distribution is configured to adequately guide wound exudate to the absorbent core while also allowing sufficient contact between the surface area of ​​the silicone layer and the skin substitute and / or the skin surrounding the wound to maintain gentle adhesion.

[0017] As described above, the wound treatment product may include discrete, segmented skin substitute portions formed within an absorbent core. By partially stamping some segments of the skin substitute into the absorbent core, the discrete skin substitute portions can be distributed on the wound contact surface of the wound treatment product. These discrete skin substitute portions are applied in a dry form, meaning that rehydration of the skin substitute is not required prior to use. In one embodiment, the discrete portions are formed as granules to allow for individual integration with the host at the wound site. These discrete portions may be in direct contact with the absorbent core or located on the wound contact surface of the polymer contact layer.

[0018] In one embodiment, the skin substitute includes 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 be used as effective skin substitutes according to the invention, and may be a preferred embodiment of the skin substitutes contemplated by the invention under certain conditions or considerations. In one embodiment, the skin substitute or skin graft material is acellular dermal matrix. Acellular dermal matrix is ​​a bioscaffold-type material, such as a fish skin product, constructed to be absorbed and grown inward by skin cells during wound healing. Acellular dermal matrix may include decellularized, freeze-dried fish skin. In one embodiment, the acellular dermal matrix includes lipids from the lipid layer of decellularized fish skin to enhance the natural healing process of human skin. In one embodiment, the skin substitute comprises an extracellular matrix article in a three-dimensional form, in granular, sheet-like, or mesh-like manner, to provide enhanced structural support and allow for improved tissue regeneration and inward cell growth. In scaffold form, the acellular dermal matrix is ​​preferably rehydrated before application; however, the scaffold can also be used in a dry form. Furthermore, the skin substitute may have an open-pore structure. This opening structure can define at least one slit extending through the thickness of the skin substitute. Providing an opening structure in the skin substitute allows for proper drainage of wound exudate during healing. The opening structure also offers greater flexibility in conforming to the surface of the wound bed.

[0019] Many other advantages and features of the invention will become more apparent from the following detailed description of the invention, the accompanying examples, the drawings, and the claims. Attached Figure Description

[0020] 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.

[0021] Figure 1 An exploded view of one embodiment of a wound treatment product is shown;

[0022] Figure 2 A cross-sectional view of one embodiment of a wound treatment product is shown;

[0023] Figure 3 A cross-sectional view of one embodiment of a wound treatment product applied to a wound surface is shown;

[0024] Figure 4 A perspective view of an exemplary skin substitute for a wound treatment product is shown;

[0025] Figure 5A A perspective view of an exemplary polymer contact layer of a wound care product is shown;

[0026] Figure 5B A perspective view of another exemplary polymer contact layer of a wound treatment product is shown;

[0027] Figure 6 A perspective view of an exemplary compliant foam layer of a wound treatment product is shown;

[0028] Figure 7 A perspective view of an exemplary receiving layer of a wound care product is shown;

[0029] Figure 8 An exemplary microcapillary is shown as an absorbent core for a wound care product;

[0030] Figure 9 A perspective view of an embodiment of a wound treatment product according to the present invention is shown;

[0031] Figure 10 A cross-sectional view of an embodiment of the wound treatment product according to the present invention is shown;

[0032] Figure 11 A schematic diagram of the negative pressure wound treatment product of the present invention is shown;

[0033] Figure 12A A cross-sectional view of one embodiment of a wound treatment product is shown;

[0034] Figure 12B A cross-sectional view of another embodiment of the wound treatment product is shown;

[0035] Figure 13A A schematic exploded cross-sectional view of one embodiment of a wound treatment product is shown;

[0036] Figure 13B A schematic exploded perspective view of one embodiment of a wound treatment product is shown;

[0037] Figure 14A A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product is shown;

[0038] Figure 14B A schematic cross-sectional view of the top membrane of one embodiment of a wound treatment product is shown;

[0039] Figure 15A , Figure 15B , Figure 15C , Figure 15D , Figure 15E and Figure 15F The flowchart illustrates the steps of using a wound treatment product according to a preferred embodiment;

[0040] Figure 16 A schematic cross-sectional view of one embodiment of a wound treatment product applied to a wound surface is shown;

[0041] Figure 17A , Figure 17B , Figure 17C , Figure 17D , Figure 17E and Figure 17F Plan views showing embodiments of wound care products of different sizes and shapes;

[0042] Figure 18A , Figure 18B , Figure 18C , Figure 18D , Figure 18E , Figure 18F and Figure 18G The flowchart illustrates the steps of using a wound treatment product according to a preferred embodiment;

[0043] Figure 19A A schematic exploded cross-sectional view of one embodiment of a wound treatment product is shown;

[0044] Figure 19B A schematic exploded perspective view of one embodiment of a wound treatment product is shown;

[0045] Figure 19C A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product is shown;

[0046] Figure 19D A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product applied to a wound bed is shown;

[0047] Figure 20A A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product is shown;

[0048] Figure 20B A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product applied to a wound bed is shown;

[0049] Figure 21 A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product is shown;

[0050] Figure 22 A schematic cross-sectional view of the contact membrane of one embodiment of a wound care product is shown.

[0051] The accompanying drawings are intended to illustrate exemplary implementations and are not drawn to scale. It should be understood that the invention is not limited to the arrangements and means shown in the drawings.

[0052] definition

[0053] 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.

[0054] The term "skin substitute" refers to a set of components or materials that can temporarily or permanently close a wound.

[0055] 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).

[0056] 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).

[0057] The term “treatment” should be understood according to its commonly used dictionary definition. That is, the term “treatment” broadly includes the provision of medical care components (i.e., bandages and dressings) and / or medicines 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 medicines used to protect something or impart specific properties to something.

[0058] 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.

[0059] Additionally, 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. Furthermore, any deep tissue damage caused by the aforementioned blast impacts may also be further included in the understanding of wound here. 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 those caused by diabetic foot ulcers, venous leg ulcers, surgical procedures, pressure ulcers, and other causes.

[0060] 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).

[0061] The term "polymer contact layer" refers to a polymer coating layer, which can be a single layer or multiple layers, and is generally impermeable to fluids, preferably impermeable to both fluids and bacteria. The polymer contact layer allows moisture to pass through. The polymer contact layer is porous, or has enough pores to allow wound exudate to pass through it.

[0062] The term "silicone layer" refers to a soft, medical-grade, silicone gel-like layer designed to act as a low-adhesion contact layer that comes into contact with the skin surrounding the wound.

[0063] The term "open structure" refers to a hole, slit, slot, pore, or opening that extends through the thickness of the layer.

[0064] 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.

[0065] 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. Detailed Implementation

[0066] Figure 1 and Figure 2 Both show schematic diagrams of the wound treatment product 100 according to the first embodiment. Figure 1 An exploded view of one embodiment of a wound treatment product is shown. Figure 2 A cross-sectional view of one embodiment of a wound treatment product is shown. Figure 1 and Figure 2In this embodiment, wound treatment product 100 is a wound dressing containing skin substitute 102 to support tissue regeneration in the wound. Like other wound treatment products described and shown herein, wound treatment product 100 is suitable for treating partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, traumatic wounds (e.g., abrasions, lacerations, partial-thickness burns, skin tears), and surgical wounds (e.g., donor / graft sites, post-Moose surgery wounds, post-laser surgery wounds, foot wounds, wound dehiscence).

[0067] Wound treatment product 100 includes a skin substitute 102 bonded to an absorbent core 104. The skin substitute 102 is attached to a polymer contact layer 114 disposed between the skin substitute 102 and the absorbent core 104. The absorbent core 104 may include: a conformable foam layer 106 for conforming to the shape of the wound bed of the wound to be treated; and a receiving layer 110 for absorbing and containing wound exudate. Wound treatment product 100 may also include a backing layer 108 to protect the wound bed 101 and the skin 103 surrounding the wound, and to protect the underlying layers of wound treatment product 100 from damage and contamination. Wound treatment product 100 also includes a release liner 112 for aseptic handling of the wound treatment product 100, the release liner 112 being configured to be removed before application to the wound site.

[0068] Figure 3 A cross-sectional view of a wound treatment product 100 applied to a wound bed 101 and the surrounding skin 103 is shown. When the wound treatment product 100 is applied to the wound, a skin substitute 102 is positioned in direct contact with the wound bed 101, allowing the skin substitute to conform to the shape of the wound to promote tissue regeneration and healing. In one embodiment, a polymer contact layer 114 located above the skin substitute 102 comprises a low-adhesion silicone layer that conforms to the shape of the wound bed 101. The polymer contact layer 114 facilitates the delivery of wound exudate through its pores (described below) and protects the skin substitute 102 and the surrounding skin 103. In one embodiment, the polymer contact layer 114 prevents absorbed wound exudate from flowing back into the wound bed 101. A conforming foam layer 106 serves to fill the gap between the wound treatment product 100 and the wound bed 101 to reduce exudate buildup and deliver exudate to the receiving layer. Figure 3 As shown, the receiving layer 110 expands to trap or lock the absorbed exudate beneath the backing layer 108. The individual layers of the wound treatment product 100 and their interlayer relationships will be described in more detail below.

[0069] Skin substitutes 102 can be broadly considered as a group of elements or materials capable of temporarily or permanently closing wounds, and preferably promoting skin growth. Skin substitutes 102 can be broadly classified into biological skin substitutes, synthetic skin substitutes, or hybrid skin substitutes comprising both biological and synthetic skin substitutes. Biological skin substitutes typically have a more complete extracellular matrix structure, while synthetic skin substitutes can be synthesized as needed and tailored for specific purposes. Biological and synthetic skin substitutes each have their advantages and disadvantages. Due to the presence of the basement membrane, biological skin substitutes can construct a more natural new dermis and have 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 a silicone component. Hybrid skin substitutes can be partially synthesized or formed by living cells and partially chemically synthesized.

[0070] 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, based on application number 17 / 703,650, which is incorporated herein by reference in its entirety.

[0071] Skin substitutes are commonly used to assist the wound healing process in cases of major wounds (e.g., large or deep wounds, or large or severe burns) or chronic wounds, aiming to facilitate a faster restoration of at least some of the aforementioned functions of healthy skin. Skin substitutes can be broadly considered as a group of components or materials capable of temporarily or permanently closing wounds. Skin substitutes are generally classified as biological skin substitutes, synthetic skin substitutes, or hybrid skin substitutes containing both biological and synthetic components.

[0072] 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 advantages and disadvantages. 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.

[0073] Whether using biological, synthetic, or hybrid skin substitutes, the goal of using skin substitutes is to achieve effective, timely, and scarless wound healing, and to restore the skin function as close as possible to its pre-wound state.

[0074] Examples of commercially available synthetic skin substitutes include Biobrane®, Dermagraft®, Integra®, Apligraf®, MatriDerm®, OrCel®, Hyalomatrix®, and Renoskin®.

[0075] US Patent Application US 2003 / 0059460 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.

[0076] Currently, the mainstream wound care products are so-called wet-to-dry wound dressings, which promote wound healing by maintaining an appropriate level of moisture at the wound site. These products typically accumulate wound exudate and require regular replacement.

[0077] Biological skin substitutes may include, but are not limited to, skin grafts, including autologous grafts, syngeneic grafts, allogeneic grafts, xenogeneic grafts (e.g., pig skin grafts), full-thickness cadaveric skin grafts, and amniotic tissue grafts.

[0078] In addition, a new class of biological skin graft products has emerged in recent years, designed to improve the wound microenvironment by providing a shelter for proliferating cells. Typically, these new products are made from biomaterials containing intact or recombinant collagen. Examples include brands such as Oasis, Mattristem, Integra, and Puracol. These products are often referred to by clinicians as matrix products. Matrix products are inserted into the wound to attract cells to grow inward. Subsequently, a secondary wet-dry wound dressing is applied on top of the wound dressing.

[0079] An example of a matrix product derived from intact decellularized fish skin is described in U.S. Patent 8,613,957 B2, granted on December 24, 2013, the entire contents of which are incorporated herein by reference. This decellularized fish skin product, as described in U.S. Patent 8,613,957, can be used as a scaffold material to support the inward growth of endothelial and / or epithelial cells. This decellularized fish skin scaffold material is biocompatible and therefore can be integrated into the host. Omega3 Wound is a commercially available skin substitute made from lightly processed wild Atlantic cod skin sourced from Iceland. The fish skin has a structure similar to human skin, possessing three basic layers comprising the epidermis, dermis, and subcutaneous tissue, and contains proteins, lipids, fatty acids, and other bioactive compounds homologous to human skin.

[0080] Examples of other biological skin substitutes include the example in U.S. Patent 6,541,023, which describes the use of porous collagen gel derived from fish skin as a tissue engineering scaffold. The process for preparing the collagen gel involves grinding the fish skin. Furthermore, Chinese Patent CN 1068703 describes a process for preparing fish skin for treating burn wounds, comprising separating the fish skin from the fish and placing it in a preservation solution containing iodine tincture, ethanol, borneol, zinc sulfadiazine, and hydrochloric acid, the amount of which is sufficient to establish a pH of 2.5-3. However, these products are more difficult to handle because the product in U.S. Patent 6,541,023 is in gel form, while the product in Chinese Patent CN 1068703 is stored in solution.

[0081] In addition, many extracellular matrix products used for medical purposes are derived from human skin (ALLODERM® regenerating tissue matrix (LifeCell)); fetal bovine dermis (PRIMATRIX™ dermal repair scaffold (TEI Biosciences)); and porcine bladder (MATRISTEM). TM extracellular matrix wound piece (Medline Industries); and porcine small intestinal submucosa (OASIS® wound matrix (Healthpoint)).

[0082] The group of skin substitutes that can be used as examples of skin substitutes according to the present invention is very large and diverse. The technical brief entitled “Skin Substitutes for the Treatment of Chronic Wounds” in the AHRQ Technical Evaluation Program (Project ID WNDT0818, published February 2, 2020, incorporated herein by reference in its entirety) lists 76 commercially available products in Table 2 on pages 9–13, with very few internal comparative studies. Each of these listed skin substitutes can serve as an embodiment of a skin substitute according to the present invention.

[0083] Figure 4 An exemplary skin substitute 102 according to the present invention is shown. In one embodiment, the skin substitute 102 is a complete decellularized fish skin product, such as the product described in U.S. Patent 8,613,957. This decellularized fish skin product serves as a scaffold material, providing a complete scaffold supporting the inward growth of endothelial and / or epithelial cells. Due to its porous scaffold design, the decellularized fish skin product enables 3D cell ingrowth. The decellularized 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] like Figure 2 As shown, the skin substitute 102 has an opening structure 125 to facilitate the drainage of wound exudate during healing. The opening structure 125 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. In one embodiment, the skin substitute 102 includes 1 to 10 linear opening structures 125, preferably 5 linear opening structures. The design of the opening structure can vary depending on the size of the skin substitute or the application of the wound treatment product 100.

[0088] In one embodiment, the skin substitute 102 is square or approximately square in shape, and its surface area A1 is between 2 square centimeters and 10 square centimeters. The surface area A1 of the skin substitute 102 can be less than 2 square centimeters or greater than 10 square centimeters; however, it is preferred that the surface area A1 of the skin substitute 102 is approximately equal to the size of the wound. The shape of the skin substitute can be various, including but not limited to square, circular, triangular, or any other symmetrical or asymmetrical and / or irregular shape, or a shape that substantially matches the shape of the wound. 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, granulated, pulverized, or otherwise processed into various sizes and shapes (square, rectangular, pentagonal, hexagonal, etc.). According to one or more embodiments, the extracellular matrix product of the skin substitute 102 can be in the form of particles, powder, flakes, or mesh formed from an extracellular matrix or a composite material containing the skin substitute material.

[0089] Figure 5A An exemplary polymer contact layer 114 according to the present invention is shown. In one embodiment, the polymer contact layer 114 includes a silicone layer adapted to contact the skin substitute 102, or optionally the skin substitute 102 and the skin 103 surrounding the wound. In one embodiment, the polymer contact layer 114 includes a silicone contact layer coated on a polyurethane membrane. This integrally overlapped silicone contact layer with a polyurethane membrane can hold the skin substitute 102 in place and helps protect the granulation wound and the skin substitute 102 after the absorbent core 104 or other covering layer has been applied thereon. In one embodiment, the polymer contact layer 114 serves as a non-adhesive or low-adhesive wound contact layer. The polymer contact layer 114 allows for painless removal from the skin. In a preferred embodiment, the polymer contact layer 114 does not adhere directly to the wound but exhibits low adhesion to the skin surrounding the wound. The polymer contact layer 114 is configured to remain in place (e.g., at the initial dressing position on the skin) for up to fourteen days. In one embodiment, the time period can be up to 14 days (product-approved lifespan), or up to the length of time that allows cell ingrowth and tissue regeneration at the wound site.

[0090] In one embodiment, the polymer contact layer 114 may include various levels of adhesion. The polymer contact layer 114 may include a central portion 120 with low adhesion strength of 0.015 to 0.85 N / cm (preferably 0.035-0.8 N / cm), wherein the edge portions 122 of the polymer contact layer 114 have greater adhesion strength. In another embodiment, the polymer contact layer 114 may include an edge portion 122 with low adhesion strength of 0.015 to 0.85 N / cm (preferably 0.035-0.8 N / cm), wherein the central portion 120 of the polymer contact layer 114 has greater adhesion strength.

[0091] In one embodiment, the polymer contact layer 114 includes a plurality of pores 124. The pores 124 are formed continuously and throughout the polymer contact layer 114. In one embodiment, the pores 124 are configured as circular pores to allow wound exudate to flow freely from the wound site through the polymer contact layer 114. In an exemplary embodiment, the diameter of the pores is between 0.5 mm and 5 mm, preferably between 1 mm and 4 mm.

[0092] The polymer contact layer 114 has a predetermined porosity to allow wound exudate to pass through its thickness. The predetermined porosity defines the distribution of pores 124 over the surface area A2 of the polymer contact layer 114. The distribution of pores 124 is configured to adequately facilitate the drainage of wound exudate while allowing sufficient contact between the surface area of ​​the silicone layer and the skin to maintain gentle adhesion. Preferably, the distribution of pores 124 over the surface area of ​​the polymer contact layer 114 has sufficient porosity without compromising the sheet-like properties of the skin substitute 102. Pores 124 are shown to be formed over the entire surface area A2 of the polymer contact layer 114. However, in another embodiment of the polymer contact layer 514 (e.g., Figure 5B As shown), the pores 524 are limited to one or more portions of the polymer contact layer 514 (e.g., the central portion 520 of the polymer contact layer 514), while no pores are provided on another portion of the polymer contact layer 514 (e.g., the edge portion that is required or configured to be disposed on the skin around the wound).

[0093] In one embodiment, such as Figure 5A and Figure 5B As shown, the polymer contact layers 114 and 514 are square and have a surface area A2 between 4 and 20 square centimeters. The surface area A2 can be less than 4 square centimeters or greater than 20 square centimeters. Preferably, the ratio of surface area A2 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. The ratio of surface area A2 to surface area A1 can vary depending on the application; however, it is preferred that surface area A2 be sufficiently larger than and fully cover surface area A1 so that the polymer contact layer 114 remains in place and in contact with the skin around the wound for the desired period of time.

[0094] In applications where the absorbent core 104 needs to be removed from the skin substitute 102, silicone is the preferred material for the polymer contact layer 114, and is superior to alternative adhesives and polymers, because it avoids dermatitis and prevents microbial growth. Furthermore, silicone exhibits low thermal conductivity, low chemical reactivity, and low toxicity due to its biocompatibility. In one embodiment, the polymer contact layer 114 is preferably transparent to allow observation of the skin around the wound and the passage of exudate through the corresponding pores 124. In another embodiment, the polymer contact layer 114 is colored or skin-colored to provide an aesthetic appearance or a clear indication of the wound site.

[0095] Figure 6 and Figure 7Various aspects of the absorbent core 104 are shown. In a preferred embodiment, the absorbent core 104 comprises a hydrophilic synthetic polymer that conforms to the body surface and is adapted to absorb fluid. The absorbent core 104 is intended to rapidly absorb exudate, thereby enhancing its effectiveness as a wound dressing, particularly by enabling the fluid to be absorbed by a receiving layer containing absorbent material. In addition to absorption, an effective wicking mechanism is also desirable; that is, the absorbent core 104 should rapidly guide fluid from its proximal surface to more distant areas (i.e., the receiving layer containing discrete portions of absorbent material) for storage, these areas being farther from the proximal surface to reduce local saturation and increase the efficiency of the absorbent core 104.

[0096] The preferred absorbent core 104 is constructed as a flexible, open-cell foam with at least slight hydrophilicity. Suitable foams have an opening size of 30 to 700 micrometers, preferably 50 to 300 micrometers. This opening allows fluid and cellular debris to be transported into and present within the foam; preferably, the opening size in each region of the foam should be sufficient to encourage capillary action and facilitate fluid transport.

[0097] The absorbent core 104 can expand to about 135% of its size when saturated with fluid. The absorbent core 104 can expand to more than 100% of its initial size, up to 200% or more, when saturated with fluid. In a preferred embodiment, the absorbent core 104 can expand to about 110% to about 170% of its initial size. In a more preferred embodiment, the absorbent core can expand to about 125% to about 155% of its initial size. When combined with the finishing layer and backing layer of the present invention, the absorbent core 104 can expand to only about 110% of its dry size when filled with exudate.

[0098] According to one embodiment of the invention, the absorber core 104 may include an aperture size gradient along the thickness direction of the absorber core 104, such that the aperture size decreases in the direction toward the distal surface of the absorber core 104. Because the aperture size is larger at and near the proximal surface of the absorber core 104, the capillary force is stronger, thus allowing fluid near the proximal surface of the absorber core 104 to be drained and directed toward the microcapillary 126. Furthermore, the absorber core 104 may include an aperture size gradient toward the microcapillary 126, thereby providing localized regions within the absorber core 104 that increase capillary forces toward the microcapillary 126 to facilitate fluid flow thereto.

[0099] Figure 6An exemplary compliant foam layer 106 of absorbent core 104 is shown, which can be used according to the wound treatment product 100. In one embodiment, the surface area A3 of the compliant foam layer 106 is substantially equal to the surface area A1 of the skin substitute. The compliant foam layer 106 comprises a foam polymer with low resilience (i.e., memory foam capability), which can leave temporary indentations in the foam after compression to improve comfort. The compliant foam layer 106 can be made, for example, of polyurethane, cellulose, carboxybutadiene-styrene rubber, polyester foam, hydrophilic epoxy foam, or polyacrylate. In a preferred embodiment, the compliant foam layer 106 can be formed of hydrophilic polyurethane foam. Since the aforementioned foams are inherently hydrophilic, and further considering the use of microcapillaries and / or superabsorbent polymers, in a preferred embodiment, it is not necessary to treat the foam to make them more hydrophilic.

[0100] The compliant foam layer 106 is viscoelastic and has sufficient flexibility and thickness to conform to the shape of the wound bed after absorbing exudate. The compliant foam layer 106 allows the wound treatment product 100 to conform to wound beds with depths between 0 and 10 cm, or 0 and 5 cm, more preferably between 0 and 4 cm, or 0 and 2 cm, to match the shape of the wound and achieve a close fit, thereby adapting to and engaging with depressions in the wound. In a preferred embodiment, the compliant foam layer 106 can compliantly penetrate wound beds up to 2 cm deep.

[0101] Figure 7An exemplary receiving layer 110 of the absorbent core 104 is shown, which can be used according to the wound treatment product 100. In one embodiment, the receiving layer 110 is formed together with the compliant foam layer 106 as a monolayer containing the same material. In another embodiment, the compliant foam layer 106 and the receiving layer 110 may be separate from each other and independent. Alternatively, the absorbent core 104 may include a multilayer structure having more than two layers. For example, the absorbent core may be a multilayer structure comprising alternating compliant foam layers 106 and receiving layers 110. Alternatively, in one embodiment, the receiving layer 110 of the absorbent core 104 may include superabsorbent polymer particles, flakes, or powder that swell upon exposure to water and form a hydration gel (hydrogel) by absorbing a large amount of water. Superabsorbent materials are defined herein as materials capable of absorbing a large amount of liquid (i.e., more than 10 to 15 parts of their own weight in liquid). These superabsorbent materials are generally classified into three categories: starch graft copolymers, crosslinked carboxymethyl cellulose derivatives, and modified hydrophilic polyacrylates. Examples of such absorbent polymers include hydrolyzed starch-acrylonitrile graft copolymers, neutralized starch-acrylic acid graft copolymers, saponified acrylate-vinyl acetate copolymers, hydrolyzed acrylonitrile copolymers or acrylamide copolymers, modified crosslinked polyvinyl alcohol, neutralized self-crosslinked polyacrylic acid, crosslinked polyacrylates, carboxylated cellulose, and neutralized crosslinked isobutylene-maleic anhydride copolymers. Superabsorbent, particulate hydrophilic polymers are also described in detail in U.S. Patent US7,468,471, issued December 23, 2008, which is incorporated herein by reference. Preferably, the superabsorbent particles in the dressings used in this invention comprise crosslinked polyacrylic acid.

[0102] Superabsorbent particles are preferably in the form of granules or flakes to increase the effective surface area of ​​the hydrophilic colloid. The size of the superabsorbent particles when dry is typically in the range of 1 to 1000 micrometers. Preferably, the particle size range of the absorbent particles is between 100 and 900 micrometers. Particles that do not dissolve in the wound environment have an absorption capacity greater than 0.5 grams of water per gram of dry particles.

[0103] Figure 8 An exemplary configuration of the microcapillaries 126 used in the absorbent core 104 of the wound treatment product 100 is shown. Each microcapillary is preferably formed as a channel 128, which includes a side pocket 130 to contain aspirated fluid or retain exudate 132. Figure 8 As shown, the side capsule 130 expands after being filled with exudate 132. In one embodiment, the microcapillary 126 includes superabsorbent particles located within the side capsule 130 to enhance fluid absorption.

[0104] Figure 9An embodiment of a wound treatment product 200 according to the present invention is shown, comprising discrete, segmented skin substitute portions 202 mechanically integrally bonded to an absorbent core 204. In one embodiment, the skin substitute portions 202 are stamped within partially formed cavities 206 and / or channels 208 in the absorbent core 204. Because the skin substitute portions 202 are mechanically integrally bonded to the absorbent core 204, the wound treatment product 200 does not require a separate polymer contact layer. In one embodiment, the skin substitute portions 202 comprise a skin substitute layer (e.g., 102) and are adapted to engage with one or more cavities 206 or channels 208 of the absorbent core 204 in a Lego-like matting manner. In another embodiment, the discrete, segmented skin substitute portions 202 are granulated and configured to be laid into the wound bed prior to application of the absorbent core 204. Thus, with its compliant properties, the absorbent core 204 applies pressure to the granulated skin substitute portions 202 along the wound bed and prevents exudate buildup.

[0105] Figure 10 An embodiment of a wound treatment product 300 is shown, which includes another means for attaching a skin substitute 302 to an absorbent core 304. The wound treatment product 300 includes a suture 306 for bonding the skin substitute 302 to the absorbent core 304. In one embodiment, the suture 306 is a biodegradable synthetic polymer that is biocompatible with the human body. The degradation rate of the biodegradable suture 306 can be tailored to its application. After the suture 306 dissolves, the absorbent core 304 can be removed from the skin substitute 302, wherein the skin substitute preferably remains integrated with the wound site to promote tissue regeneration.

[0106] Figure 11 A negative pressure wound therapy (“NPWT”) application system 401, including the wound treatment product 400 of the present invention, is shown. Figure 11The wound treatment product 400 shown in conjunction with negative pressure wound therapy can be any wound treatment product as shown and described herein. The NPWT application system 401 continuously or intermittently applies subatmospheric pressure to the wound surface. The wound treatment product includes a skin substitute 402 and an absorbent core 404. The wound treatment product 400 is connected to a single-lumen or multi-lumen tube or catheter 410 operably connected to a pump assembly. The catheter 410 is integrally integrated with the closed wound treatment product 400 and connected to the absorbent core 404. The wound contact surface of the wound treatment product 400 (i.e., the skin substitute 402) is porous to allow for uniform pressure distribution across the entire wound surface. The dressing of the wound treatment product 400 is in direct contact with the wound, and the NPWT application system 401 includes a drainage tube attached to a vacuum device. The wound treatment product 400 includes a backing layer 408 formed of an airtight material. In a preferred embodiment, the backing layer 408 comprises polyurethane and extends approximately 2 cm beyond the wound edge to provide an airtight seal. In a preferred embodiment, the wound treatment product 400 includes discrete, incompressible support strips 406 to form a continuous tension network to refine the shape of the wound treatment product 400 and to distribute pressure evenly across the wound bed. The support strips 406, together with the absorbent core 404 and the negative pressure provided by the NPWT application system 401, synergistically promote the vertical absorption of exudate.

[0107] Figure 12A and Figure 12B A schematic wound treatment product 1200 according to another similar embodiment is shown. Figure 12A and Figure 12B In both embodiments, wound treatment product 1200 is a wound dressing comprising an intact skin substitute 1202 to support tissue regeneration in the wound. Figure 1 and Figure 2 Similar to the wound treatment products shown in the embodiments, wound treatment product 1200 is also suitable for treating the following wounds: partial and full skin wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, traumatic wounds (e.g., abrasions, lacerations, partial skin burns, skin tears), and surgical wounds (e.g., donor / graft sites, post-Moll's procedure wounds, post-laser procedure wounds, foot wounds, wound dehiscence).

[0108] Figure 12A and Figure 12BEach wound treatment product 1200 includes a skin substitute 1202 and an absorbent core 1204, with the skin substitute 1202 bonded to the absorbent core 1204. The skin substitute 1202 is attached to a polymer contact layer 1214 disposed between the skin substitute 1202 and the absorbent core 1204. The absorbent core 1204 includes an compliant foam layer 1206 and a receiving layer 1210 for absorbing and containing wound exudate. The wound treatment product 1200 also includes a backing layer 1208 to protect the wound bed and the skin surrounding the wound, and to protect the underlying layers from damage and contamination. The wound treatment product 1200 also includes a release liner 1212 for aseptic handling of the wound treatment product 1200 before application to the wound site.

[0109] exist Figure 12A and Figure 12B In one embodiment, the polymer contact layer 1214 and the skin substitute 1202 include a plurality of pores 1226 that penetrate and are aligned with each other in the polymer contact layer 1214 and the skin substitute 1202. The pores 1226 are formed continuously and through the polymer contact layer 1214 and the skin substitute 1202. All or part of the pores penetrating the polymer contact layer 1214 communicate with and are aligned with all or part of the pores in the skin substitute 1202. In one embodiment, the pores 1226 are configured as circular holes to allow wound exudate to flow freely from the wound site through the polymer contact layer 1214. In an exemplary embodiment, the diameter of the pores is between 0.5 mm and 5 mm, preferably between 1 mm and 4 mm.

[0110] Figure 12A and Figure 12B The embodiments contain similar materials and generally similar structures, but Figure 12A and Figure 12B The embodiments differ from each other in the relative dimensions or diameters of the layers in the skin substitute 1202, polymer contact layer 1214, and absorbent core 1204. In a preferred embodiment, such as Figure 12BAs shown, the width or diameter of the polymer contact layer 1214 is substantially the same as or close to that of the layers in the absorbent core 1204, including being similar to, the same as, or close to the width or diameter of the receiving layer 1210 and the compliant foam layer 1206. In a more preferred embodiment, the polymer contact layer 1214 is similar in size to the layers in the absorbent core 1204, but the polymer contact layer 1214 is only slightly larger than the layers in the absorbent core 1204 to prevent possible contact at the edge between the skin substitute 1202 and the absorbent core 1204 after it has been applied to the wound and the area size of the absorbent core 1204 has changed due to absorption. In another preferred embodiment, the area of ​​the compliant layer 1206 is slightly larger than that of the receiving layer 1210 of the absorbent core 1204. However, as shown in the embodiments, the relative widths and / or diameters of the different layers (e.g., receiving layer 1210 and compliant foam layer 1206) in the polymer contact layer 1214, skin substitute 1202, and absorbent core 1204 can vary relative to each other to achieve the desired functionality. The relative dimensions shown should be understood as non-limiting.

[0111] Similarly, the embodiments shown herein (including) Figure 1 and Figure 2 as well as Figure 12A and Figure 12BThe embodiments described herein should be understood as illustrative and not necessarily as showing the relative thicknesses of different layers of the wound care product. In a preferred embodiment, the thickness of the absorbent core 1204 may be set or determined based on the required functionality and absorbency properties of the wound care product. In one embodiment, the initial thickness of the absorbent core 1204 (before absorbing liquid) may be between 0.01 and 500 mm, between 0.1 and 100 mm, between 0.2 and 50 mm, between 0.3 and 30 mm, or between 0.4 and 20 mm. In a more preferred embodiment, the thickness of the absorbent core is between 1 and 10 mm. Furthermore, the thickness of the different layers in the absorbent core 1204 may vary. For example, the thickness of the compliant foam layer 1206 may be between 0.01 and 300 mm, between 0.1 and 100 mm, between 0.2 and 50 mm, between 0.3 and 30 mm, between 0.4 and 20 mm, or between 0.5 and 10 mm. In a preferred embodiment, the thickness of the compliant foam layer 1206 is between about 1 and 5 mm, and preferably between 1.5 and 4 mm, even more preferably between about 2 and 3 mm, and most preferably about 2.3 mm. The thickness of the receiving layer 1210 may also be between 0.01 and 300 mm, between 0.1 and 100 mm, between 0.2 and 50 mm, between 0.3 and 30 mm, between 0.4 and 20 mm, or between 0.5 and 10 mm. In a preferred embodiment, the thickness of the receiving layer 1210 is between about 1 and 5 mm, more preferably between 1.5 and 5 mm, more preferably between about 2 and 5 mm, more preferably between 2.5 and 4.5 mm, and most preferably about 3.5 mm. Figure 1 and Figure 2 The thickness of each layer in the absorber core 104 can be shared as Figure 12A and Figure 12B The similar ranges and values ​​provided by the embodiments.

[0112] The skin substitute 1202 has a first thickness T1. Generally, the first thickness can be between about 0.1 and 10 mm, preferably between about 0.1 and 4.0 mm (i.e., cross-sectional thickness), for example, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, or 3.5 mm thick. The thickness can be based on a variety of factors, including the type of skin substitute, and in the case of a fish skin substitute, the thickness is based on the species of fish used as the starting material, processing, freeze-drying, and / or rehydration, as described in more detail in U.S. Patent 8,613,957. In one embodiment, the skin substitute 1202 has multiple layers. In one embodiment, the thickness is uniformly consistent over the surface area A1 of the skin substitute 1202. In another embodiment, the first thickness may decrease at the edges defining the surface area A1 of the skin substitute 1202.

[0113] The polymer contact layer 1214 also has a certain thickness. The total thickness of the polymer contact layer 1214 (i.e., the thickness of all layers included in the contact layer 1204 if the contact layer is a multilayer structure or a multilayer film) is preferably greater than 0.2 mm. Generally, the thickness of the contact layer 1204 is between about 50 and 200 gsm, for example, 100, 110, 120, 130, 140, 150, 160, 170, 180, or 190 gsm. “GSM”, or grams per square meter, is a unit for measuring the thickness of materials such as paper and fabrics. The gsm thickness is based on the weight of the silicone gel used in the silicone layer of the contact layer and the surface area A2 of the silicone layer. In one embodiment, the second thickness of the contact layer is uniform across the surface area A2 of the contact layer 1214. In another embodiment, the second thickness of the contact layer 1214 decreases at the edges that define the surface area A2 of the silicone layer 106. In one embodiment, the second thickness T2 decreases at the central portion of the polymer contact layer 1214 to receive and partially accommodate the skin substitute 1202 within the recess. Generally, the thickness of the contact layer allows it to have sufficient flexibility and elasticity to conform to the recess of the wound bed along with the skin substitute. The contact layer preferably also exhibits stability and strong resistance to moisture and organic solvents.

[0114] The polymer contact layer 1214 and the skin substitute 1202 have a predetermined porosity to allow wound exudate to pass through the thickness of the polymer contact layer 1214. The predetermined porosity defines the distribution of pores 1226 over the surface area of ​​the polymer contact layer 1214 and the skin substitute 1202. The distribution of pores 1226 is configured to adequately facilitate the drainage of wound exudate while allowing sufficient contact between the surface area of ​​the silicone layer and the skin to maintain gentle adhesion. Preferably, the distribution of pores 1226 over the surface area of ​​the polymer contact layer 1214 and the skin substitute 1202 has sufficient porosity without compromising the sheet-like properties or integrity of the skin substitute 1202. The pores 1226 shown are formed over the entire surface area of ​​the polymer contact layer 1214 and the skin substitute 1202. However, in another embodiment of the polymer contact layer, the pores are limited to one or more portions of the polymer contact layer (e.g., the central portion), and no pores are provided in other portions of the polymer contact layer (e.g., edge portions that are required or configured to be arranged on the skin around the wound).

[0115] Figure 13A and Figure 13B Both show schematic diagrams of a wound treatment product 1300 according to another embodiment. Figure 13A and Figure 13B In one embodiment, wound treatment product 1300 is a wound dressing that includes a complete skin substitute 1302 for supporting tissue regeneration (particularly skin regeneration) in the wound.

[0116] Wound treatment product 1300 includes a skin substitute 1302 and an absorbent core 1304. The skin substitute 1302 is attached to a contact membrane 1314 disposed between the skin substitute 1302 and the absorbent core 1304. The absorbent core 1304 includes an compliant foam layer 1306 and an absorbent layer 1310 for absorbing and containing wound exudate. Wound treatment product 1300 includes a backing layer 1320, which, as a backing layer or top layer or top membrane, can be used to protect the underlying layers (1302, 1314, 1304) from damage and contamination, while also protecting the wound bed 1301 and the skin 1303 surrounding the wound. The backing layer 1320 is preferably a multilayer membrane, and in a preferred embodiment includes an outer layer 1322 covering an inner layer 1321. Wound treatment product 1300 also includes a release liner 1312 for aseptic handling of the wound treatment product 1300 before application to the wound site.

[0117] exist Figure 13A and Figure 13B In one embodiment, the surface area of ​​the skin substitute 1302 is smaller than that of the contact film 1314, allowing the contact film 1314 to extend beyond the edge of the skin substitute 1302. Figure 13A and Figure 13B In this embodiment, the absorbent core 1304 (including an absorbent layer 1310 disposed above the compliant foam layer 1306) is substantially similar in size to the surface area of ​​the contact membrane 1314. Preferably, the area of ​​the absorbent layer 1310 is slightly smaller than that of the compliant foam layer 1306 to prevent contact between the absorbent layer 1310 and the skin 1303 surrounding the wound. In this embodiment, the backing layer 1320 preferably comprises an outer layer 1322 and an inner layer 1321. Preferably, the peripheral edges of the outer layer 1322 and the inner layer 1321 are aligned such that the areas spanned by the outer layer 1322 and the inner layer 1321 are the same or substantially the same. Furthermore, the backing layer 1320 and the release liner 1312 span similar areas and are preferably aligned. The areas of both the backing layer 1320 and the release liner 1312 are larger than their internal layers (skin substitute 1302, contact film 1314, and absorbent core 1304), such that the inner surface of the release liner 1312 can contact the lower inner surface of the inner layer 1321 of the backing layer 1320.

[0118] like Figure 13A and Figure 13B As shown, the release liner 1312 preferably comprises two portions 1312-1 and 1312-2 that meet and contact each other (preferably, but not necessarily, at or near the center), wherein the first portion 1312-1 of the release liner 1312 may overlap with the second portion 1312-2, and the second portion 1312-2 may be folded outward to facilitate gripping by medical personnel when applying the wound treatment product 1300. Alternatively, the first portion 1312-1 may be a folded, shorter component, while the second portion 1312-2 may be a longer component that overlaps with the shorter first portion 1312-1 for ease of peeling. Both portions of the release liner 1312 may be made of a plastic material, a polymer material, or, for example, a thermoplastic. In a preferred embodiment, the release liner is made of low-density polyethylene (LDPE). Such LDPE preferably has a density range between 917 and 930 kg / m³. Preferably, the release liner 1312 is made of a material that is impact-resistant, flexible, moisture-resistant, and has good chemical resistance. In other embodiments, the release liner 1312 may also be made of or contain other polyethylene materials, such as high-density polyethylene (HDPE) and linear low-density polyethylene (LLPDE), polypropylene (PP), polyolefins, and / or polyethylene terephthalate (PET). According to another embodiment, the release liner 1312 may be made of or contain thin-layer polyvinyl chloride (PVC) and / or polyethylene terephthalate-co-1,4-cyclohexanediol (PETG). The release liner 1312 may be a single-layer structure or a multi-layer structure.

[0119] In a preferred embodiment, skin substitute 1302 is an extracellular scaffold / matrix product derived from intact decellularized fish skin, as described in U.S. Patent 8,613,957 B2, granted December 24, 2013, the entire contents of which are incorporated herein by reference. The decellularized fish skin product described in U.S. Patent 8,613,957 serves as a scaffold material, providing an intact scaffold supporting the inward growth of endothelial and / or epithelial cells. This decellularized fish skin scaffold material is biocompatible and therefore can be integrated by the host. Omega3 Wound is a commercially available skin substitute made from lightly processed wild Atlantic cod skin sourced from Iceland. The structure of this fish skin is similar to human skin, having three basic layers comprising the epidermis, dermis, and subcutaneous tissue, and containing proteins, lipids, fatty acids, and other bioactive compounds homologous to human skin. However, in Figure 13A and Figure 13B In some embodiments, the skin substitute 1302 is not limited to extracellular scaffold / matrix products derived from intact decellularized fish skin, and may include or consist of other various skin substitutes described above as alternatives.

[0120] Similar to Figure 4 The skin substitute shown Figure 13B The skin substitute 1302 shown may include openings 118 to facilitate drainage of wound exudate during healing. Openings 125 may be designed as grooves, holes, pores, or other openings to allow proper drainage from the wound contact surface 116 through the thickness T1 of the skin substitute 1302. Setting the openings 125 as grooves allows exudate to flow through the skin substitute 102 and increases the flexibility of the wound treatment product 1300, while reducing product waste and increasing the contact area between the skin substitute 102 and the wound site. In one embodiment, the skin substitute 102 includes 1 to 10 linear openings 125, preferably 5 linear openings. The design of the openings can vary depending on the size of the skin substitute or the application of the wound treatment product 100. Alternatively, as an alternative or additional step, the skin substitute 1302 may include small pores (e.g., circular pores) that also allow proper drainage of wound exudate through the thickness of the skin substitute 1302.

[0121] In a preferred embodiment, the contact film 1314 has a multilayer structure. For example... Figure 14AAs shown, the contact membrane 1314 may include, for example, a core layer 1314-1 disposed between a first outer layer 1314-2 at the top and a second outer layer 1314-3 at the bottom. In a preferred embodiment, the core layer 1314-1 is made of a plastic material, a polymer material, or, for example, a thermoplastic. In a preferred embodiment, the core layer 1314-1 of the contact membrane 1314 is made of polyethylene terephthalate (PET). Preferably, the material of the core layer 1314-1 of the contact membrane 1314 is impact-resistant, flexible, moisture-resistant, and has good chemical resistance. In other embodiments, the core layer 1314-1 of the contact membrane 1314 may be made of or contain other polyethylene materials, such as high-density polyethylene (HDPE) and linear low-density polyethylene (LLPDE), polypropylene (PP), and / or made of low-density polyethylene (LDPE). According to another embodiment, the core layer 1314-1 of the contact membrane 1314 may be made of or contain thin layers of polyvinyl chloride (PVC) and / or polyethylene terephthalate-co-1,4-cyclohexanediol (PETG). The core layer 1314-1 of the contact membrane 1314 itself may be a single-layer structure or a multi-layer structure.

[0122] like Figure 14A As shown, a silicone adhesive layer is preferably provided on the core layer 1314-1 of the contact film 1314 as a top layer 1314-2 and a bottom layer 1314-3. The silicone adhesive layers serving as the top layer 1314-2 and the bottom layer 1314-3 can be of the same type or can be different silicone adhesive materials. The upper surface 1314-4 of the top layer 1314-2 is configured to contact the bottom surface of the conformal foam layer 1306. The bottom surface 1314-5 of the bottom layer 1314-3 is configured to contact the top surface of the skin substitute 1302.

[0123] The skin substitute 1302 is in direct contact with the contact membrane 1314 at a silicone adhesive layer 1314-3, which is a slightly adhesive silicone material. Thus, the wound treatment product 1300 can be configured to be applied to a wound bed 1301 such that the skin substitute 1302 is in contact with the wound bed 1301, with the contact membrane 1314 positioned between the skin substitute 1302 and the absorbent core 1304. The contact membrane 1314 is integrally bonded to the absorbent core 1304 and removably attached to the skin substitute 1302. The underlying silicone adhesive layer 1314-3 advantageously contacts the skin substitute 1302 material directly and is biocompatible with the skin. Furthermore, the contact membrane preferably prevents exudate from flowing back from the absorbent core 1304 to the wound bed 1301 under pressure. In one embodiment, the silicone layer 1314-3 provides a gentle adhesive bond to the skin substitute 1302 for proper fixation and painless separation after healing. The silicone layer has sufficient adhesiveness to eliminate the need for an adhesive between the silicone layer and the skin graft material. An exemplary polymeric contact layer for use with a silicone adhesive layer of the underlying 1314-3 is described in more detail in U.S. Provisional Application 63 / 541,661 entitled “Wound Dressing,” filed September 29, 2023, which is incorporated herein by reference in its entirety.

[0124] In a preferred embodiment, the silicone adhesive layer 1312-3 has sufficient adhesiveness to eliminate the need for an additional adhesive between the silicone layer 1312-3 and the skin substitute 1302. Preferably, according to one embodiment, the contact membrane comprising the silicone layer 1314-3 and the core layer 1314-1 is hydrophobic and impermeable to liquids, allowing the wound treatment product to be fully immersed in a saline solution before application to the skin. Advantageously, the silicone layer 1314-3 retains its low adhesiveness after immersion. After the skin graft material 1302 is applied to the wound, the silicone layer 1314-3 of the film layer 1314 is configured to be easily detachable from the skin substitute after a period of time. In one embodiment, this period can be up to 14 days, or it can be a time window that allows for inward cell growth and tissue regeneration at the wound site. During the removal of the contact membrane 1314, the decellularized dermal matrix of the skin substitute can remain on or integrally incorporated into the wound surface and can be absorbed by the wound during healing without being disturbed or damaged when the contact membrane 1314 is finally removed from the skin substitute 1302. For the silicone adhesive layer 1314-3, sufficient tackiness can be defined as an adhesive force between 0.015 and 0.85 N / cm, preferably between 0.035 and 0.8 N / cm.

[0125] Similarly, the top layer 1314-2 of the contact film 1314 is an adhesive layer, preferably a silicone adhesive layer, which provides sufficient adhesion to allow the contact film 1314 to be separated from the bottom surface of the compliant foam layer 1306, thereby allowing the absorbent core 1304 to be separated from the top layer 1314-2 of the contact film 1314 without allowing the bottom layer 1314-3 of the contact film 1314 to be separated from the skin substitute 1302. Therefore, after the absorbent core 1304 (especially the absorbent layer 1310 of the absorbent core 1304) is saturated or needs to be replaced, the layers above it (absorbent core 1304 and backing layer 1320) can be removed and replaced with a new set of upper layers (absorbent core 1304' and backing layer 1320'), which will be described below.

[0126] The contact membrane 1314 has a predetermined porosity to allow wound exudate to pass through the thickness of the contact membrane 114. The predetermined porosity defines the distribution of pores 1324 on the surface area A2 of the polymer contact layer 1314. The distribution of pores 1324 is configured to adequately facilitate the drainage of wound exudate while allowing sufficient contact between the surface area of ​​the silicone adhesive layer and the skin substitute to maintain gentle adhesion, and sufficient contact between the top silicone adhesive layer 1314-2 and the absorbent core 1304. Preferably, the distribution of pores 1324 on the surface area of ​​the polymer contact layer 1314 has sufficient porosity without impairing the sheet-like properties of the skin substitute 1302. The pores 1324 shown are formed over the entire surface area A2 of the polymer contact layer 114. However, similar to Figure 5B In the embodiment shown, the pores 1324 may be limited to one or more portions of the polymer contact layer (e.g., the central portion of the contact membrane 1314), with no pores provided in another portion of the polymer contact layer 1314 (e.g., the edge portions that are required or configured to be arranged above the skin around the wound).

[0127] The absorbent core 1304 includes a compliant foam layer 1306 and an absorbent layer 1310 for absorbing and containing wound exudate. In a preferred embodiment, the compliant foam layer 1306 is configured to absorb exudate from the wound and provide a three-dimensional foam structure conforming to the wound surface, and to effectively apply pressure to expel excess exudate from the wound surface, thereby allowing exudate to pass through the pores 1324 of the contact membrane 1304, similar to... Figure 3As shown in the embodiments. In a preferred embodiment, the absorbent layer 1310 is a superabsorbent layer, bonded to the top surface of the compliant foam layer 1306 using a permanent pressure-sensitive hot melt adhesive (PSA) or hot melt adhesive. The PSA hot melt adhesive may include a blend of synthetic rubber, acrylic, or silicone polymers with tackifiers and stabilizers to form a pressure-sensitive adhesive. Other forms of adhesives or glues may also be used to bond the absorbent layer 1310 to the compliant foam layer 1306. The absorbent layer 1310 can lock in exudate received from the wound. In a preferred embodiment, the surface area of ​​the absorbent layer 1310 is smaller than the surface area of ​​the compliant foam layer 1306 to ensure that its edges are sealed when the wound treatment product 1300 is assembled with the backing layer 1320, thereby preventing contact between the absorbent layer 1310 and the skin 1303 surrounding the wound.

[0128] In a preferred embodiment, the absorbent core 1304 preferably comprises a hydrophilic synthetic polymer that conforms to the body surface and is adapted to absorb fluids. It is contemplated that the absorbent core 1304 can rapidly absorb exudate, thereby enhancing its effectiveness in wound care products, particularly by drawing fluid into a receiving layer containing absorbent material. In addition to absorption, an effective wicking mechanism is desired; that is, the absorbent core 1304 should rapidly guide fluid from its proximal surface to more distant areas (i.e., the receiving layer containing discrete absorbent material portions) for storage, thereby reducing local saturation and increasing the efficiency of the absorbent core 1304.

[0129] The preferred absorbent core 1304 is constructed as a flexible, open-cell foam that is at least slightly hydrophilic. Suitable foams have an opening size of 30 to 700 micrometers, preferably 50 to 300 micrometers. This opening allows fluids and cellular debris to be transported into and present within the foam; preferably, the opening size in each region of the foam should be sufficient to encourage capillary action and facilitate fluid transport.

[0130] The absorbent core 1304 may expand to about 135% of its size when saturated with fluid. When bonded to and confined by the top layer of a wound treatment product, the absorbent core 104 may expand to only about 130%, 120%, or 110% of its dry size when saturated with exudate.

[0131] According to one embodiment of the invention, the absorber core 1304 may include an aperture size gradient along the thickness direction of the absorber core 1304, such that the aperture size decreases in the direction toward the distal surface of the absorber core 1304. Because the aperture size is larger at and near the proximal surface of the absorber core 1304, the capillary force is stronger, thus allowing fluid near the proximal surface of the absorber core 1304 to be drained and directed toward the microcapillaries. Furthermore, the absorber core 1304 may include an aperture size gradient toward the microcapillaries, thereby providing localized regions within the absorber core 1304 that increase capillary forces toward the microcapillaries to facilitate fluid flow thereto.

[0132] According to one embodiment, the compliant foam layer 1306 comprises a foam polymer with low resilience (i.e., memory foam capability), which can leave temporary indentations in the foam after compression to improve comfort. The compliant foam layer 1306 can be made, for example, of polyurethane, cellulose, carboxylated butadiene-styrene rubber, polyester foam, hydrophilic epoxy foam, or polyacrylate. In a preferred embodiment, the compliant foam layer 1306 can be formed from hydrophilic polyurethane foam. Because the aforementioned foams are inherently hydrophilic, and further considering the use of microcapillaries and / or superabsorbent polymers, in a preferred embodiment, it is not necessary to treat the foams to make them more hydrophilic.

[0133] In one embodiment, the compliant foam layer 1306 is viscoelastic and has sufficient flexibility and thickness to conform to the shape of the wound bed after absorbing exudate. The compliant foam layer 1306 allows the wound treatment product 1300 to conform to a wound bed with a depth between 0 and 4 cm to match the shape of the wound and achieve a close fit. In a preferred embodiment, the compliant foam layer 106 can conformally penetrate a wound bed with a depth of up to 2 cm.

[0134] In one embodiment, the receiving layer 110 is formed as a monomer layer together with the compliant foam layer 1306, and in some embodiments may contain the same material. In another embodiment, the compliant foam layer 106 and the receiving layer 110 may be separate from each other and independent. In one embodiment, the receiving layer 1310 of the absorbent core 1304 may include superabsorbent polymer particles, flakes, or powders that swell upon exposure to water and form a hydration gel (hydrogel) by absorbing a large amount of water. Superabsorbent materials are defined herein as materials capable of absorbing a large amount of liquid (i.e., more than 10 to 15 parts of their own weight). These superabsorbent materials are generally classified into three categories: starch graft copolymers, crosslinked carboxymethyl cellulose derivatives, and modified hydrophilic polyacrylates. Examples of such absorbent polymers are hydrolyzed starch-acrylonitrile graft copolymers, neutralized starch-acrylic acid graft copolymers, saponified acrylate-vinyl acetate copolymers, hydrolyzed acrylonitrile copolymers or acrylamide copolymers, modified crosslinked polyvinyl alcohol, neutralized self-crosslinked polyacrylic acid, crosslinked polyacrylates, carboxylated cellulose, and neutralized crosslinked isobutylene-maleic anhydride copolymers. Superabsorbent, particulate hydrophilic polymers are also described in detail in U.S. Patent 7,468,471, issued December 23, 2008, which is incorporated herein by reference. Preferably, the superabsorbent particles in the dressings used in the present invention comprise cross-linked polyacrylic acid.

[0135] Superabsorbent particles are preferably in the form of granules or flakes to increase the effective surface area of ​​the hydrophilic colloid. The size of the superabsorbent particles when dry is typically in the range of 1 to 1000 micrometers. Preferably, the particle size range of the absorbent particles is between 100 and 900 micrometers. Particles that do not dissolve in the wound environment have an absorption capacity greater than 0.5 grams of water per gram of dry particles.

[0136] like Figure 13A and Figure 13B as well as Figure 14BAs shown, the wound treatment product 1300 includes a backing layer 1320, which serves as a backing layer to protect the underlying layers (1302, 1314, 1304) from damage and contamination, while also protecting the wound bed 1301 and the skin 1303 surrounding the wound. The backing layer 1320 is preferably a multilayer film, and in a preferred embodiment, includes an outer layer 1322 covering an inner layer 1321. The inner layer 1321 defines an unoccupied internal space 1323 such that the backing layer 1320 has a recess in the space 1323. That is, the inner layer 1321 removes a central portion in the space 1323, retaining only the edge portion. Thus, the top surface of the absorbent layer 1310 can contact the inner bottom surface 1322-2 of the outer layer 1322 through the space 1323 defined by the inner layer 1321. The silicone adhesive can be applied to the bottom surface 1321-1 of the inner layer 1321, and when the wound treatment product 1300 is applied to the patient's wound, the adhesive combines with the skin (preferably the skin around the patient's wound).

[0137] In a preferred embodiment, the outer layer 1322 is a breathable membrane, preferably a breathable plastic membrane, more preferably a thermoplastic polyurethane (PU) membrane. In a preferred embodiment, the outer layer 1322 is adhered to the top surface of the inner layer 1321 at surface 1308-2 using an acrylic adhesive or other adhesive. In a preferred embodiment, the adhesion between the outer layer 1322 and the top surface of the inner layer 1321 at surface 1308-2, and the adhesion between the outer layer 1322 and the top surface of the absorbent layer 1310 at surface 1322-2, are sufficiently strong to ensure that the foam core 1304 (including the compliant foam layer 1306 and the absorbent layer 1310) can remain on the outer membrane 1322 of the backing layer 1320 when removed from the patient after treatment. In a preferred embodiment, the inner layer 1321 is also a breathable membrane, preferably a breathable plastic membrane, more preferably a thermoplastic polyurethane (PU) membrane, and preferably does not contact the absorbent layer 1310 of the compliant foam layer 1306. It should be noted that the outer layer 1322 and the inner layer 1321 may also comprise other breathable membrane materials. For example, these membranes may be made of or comprise combinations of membrane materials, such as breathable thermoplastic copolyesters (TPCs) (e.g., Arnitel®), breathable polyethylenes (e.g., Lumicene® M4040 and Supertough® 33ST22, or Sof-Flex™), or other films, not limited to plastic or polymer-based membranes, but also including other bio-based membranes, or other types of films that are permeable to water vapor but impermeable to liquids. In a preferred embodiment, the material of the outer layer 1322 is sufficiently elastic to stretch to accommodate the expansion of the absorbent core 1304 (particularly the absorbable receiving layer 1310).

[0138] Although schematically shown in the figures, the thickness of the backing layer 1320 can vary and should not be construed from the figures as necessarily having a specific thickness relative to other layers of the product. The thickness of the backing layer 1320 can be between 0.01 and 1000 μm, between 0.1 and 500 μm, between 0.2 and 200 μm, between 0.3 and 100 μm, between 5 and 90 μm, and between 10 and 80 μm. In a preferred embodiment, the thickness of the outer layer 1322 is between about 1 and 100 μm, preferably between 10 and 60 mm, more preferably between about 20 μm and 50 μm, and most preferably about 30 μm. In a preferred embodiment, the thickness of the inner layer 1321 with the acrylic adhesive is between about 1 and 100 μm, preferably between 10 and 60 mm, more preferably between about 20 μm and 50 μm, and most preferably about 45 μm.

[0139] Figure 15A , Figure 15B , Figure 15C , Figure 15D , Figure 15E and Figure 15F The procedure for using wound care product 1300 is shown. Figure 15A The present invention provides a wound treatment product 1300-1, which has the same characteristics as... Figure 13A and Figure 13B Similar features to wound treatment product 1300. Release liner 1312 remains intact for aseptic handling of wound treatment product 1300 before application to the wound site. Furthermore, the wound treatment product can be housed in a removable sterile packaging material. Figure 15A The term "wound care product" has been removed. This means that after assembly, the wound care product can be packaged in synthetic flash-evaporated high-density polyethylene fiber packaging (such as Tyvek) or other suitable packaging materials.

[0140] exist Figure 15B In this configuration, the release liner 1312 has been removed, and the wound treatment product 1300-2 has been applied to the wound surface, allowing the skin substitute 1302 to come into direct contact with the wound bed 1301. The contact surface 1321-1 of the inner layer 1321 of the backing layer 1320 contacts the skin around the wound 1301 of the subject, and as described above, a silicone adhesive can be applied to the contact surface 1321-1 to retain and adhere the wound treatment product to the patient's skin.

[0141] Figure 15CThe image shows the wound treatment product 1300-3 after a sufficiently long period of time, at which point the contact membrane 1304 has absorbed the wound exudate, and the compliant foam layer 1306 and absorbent layer 1310 have increased in size due to the absorption of the wound exudate.

[0142] After a certain period of time, the compliant foam layer 1306 and absorbent layer 1310 may become fully saturated, or to keep the wound treatment product 1300 clean and dry, the backing layer 1320 and the upper layer of the absorbent core 1304 can be removed, leaving the skin substitute 1302 and contact film 1304 on the wound bed 1301, as follows. Figure 15D As shown.

[0143] like Figure 15E As shown, a replaceable upper portion 1350 of a wound care product is provided, which includes an absorbent core 1304' (comprising an compliant foam layer 1306' and an absorbent layer 1310') and a backing layer 1320' (comprising an outer layer 1322' and an inner layer 1321'), similar to... Figure 13A and Figure 13B The corresponding absorbent core 1304, compliant foam layer 1306, absorbent layer 1310, backing layer 1320, outer layer 1322, and inner layer 1321 are shown. A release liner 1312' is also provided, which contacts the lower surface of the compliant foam layer 1306' and the contact surface of the inner layer 1321'.

[0144] like Figure 15F As shown, the release liner 1312' is removed, and the wound treatment product 1300-5 is updated by placing the replaced upper portion 1350 onto the remaining contact membrane 1304 and skin substitute 1302. Therefore, with the updated wound treatment product 1300-5 having a new absorbent core 1304', additional and greater exudate can be absorbed by the new absorbent core 1304', and the removed upper portion can be discarded.

[0145] Figure 16A cross-sectional view of a wound treatment product 1600 applied to a wound bed 1301 and the surrounding skin 1303 is shown. The skin substitute 1302 is in direct contact with the wound bed 1301, conforming to the shape of the wound to promote tissue regeneration and healing. In one embodiment, a contact membrane 1314 disposed on the skin substitute 1302 comprises a low-adhesion silicone adhesive layer that conforms to the shape of the wound bed 101 and contacts the skin substitute 1302. The contact membrane 1314 facilitates the drainage of wound exudate through pores (as described above) and protects the skin substitute 1302 and the surrounding skin 1303. In one embodiment, the contact membrane 1314 prevents absorbed wound exudate from flowing back to the wound bed 1301. A conforming foam layer 1306 serves to fill the gap between the wound treatment product 1300 and the wound bed 101 to reduce exudate buildup and drain exudate to the receiving layer. Figure 16 As shown in the schematic diagram, the absorbent layer 1310 expands to trap or lock the absorbed exudate below the backing layer 1320.

[0146] Figure 17A , Figure 17B , Figure 17C , Figure 17D , Figure 17E and Figure 17F Examples of preferred wound treatment products 1700 with different geometries, sizes and shapes are shown.

[0147] exist Figure 17A and Figure 17B In the images, wound treatment products 1700-A and 1700-B are shown to have a generally square shape, wherein the skin substitute 1702, the absorbent core 1704 and the top membrane 1720 each have a generally square shape and have increasing corresponding diameters dS, dF and dTF.

[0148] exist Figure 17C and Figure 17D In the examples, wound treatment products 1700-C and 1700-D are shown to have a generally square shape, wherein the absorbent core 1704 and the top membrane 1720 have a generally square shape, while the skin substitute 1702 has a circular shape. In these examples, the skin substitute 1702, the absorbent core 1704, and the top membrane 1720 have correspondingly increasing diameters dS, dF, and dTF.

[0149] Table 1 below lists Figure 17A – Figure 17D The example shown is a non-restrictive comparison of dimensions.

[0150] Table 1

[0151]

[0152] exist Figure 17E and Figure 17F The examples shown depict elongated wound treatment products, with wound treatment product 1700-E having a rectangular shape and wound treatment product 1700-F having a generally rectangular shape and an elliptical skin substitute. In wound treatment products 1700-E and 1700-F, the skin substitute 1702, the absorbent core 1704, and the top membrane 1720 all have increasing corresponding minor axis diameters dS1, dF1, and dTF1, and increasing corresponding major axis diameters dS2, dF2, and dTF2. Although not shown, in other embodiments, the wound treatment products may also have asymmetrical shapes.

[0153] Figure 18A , Figure 18B , Figure 18C , Figure 18D , Figure 18E , Figure 18F and Figure 18G Another process is shown illustrating the steps of using the wound treatment product 1800 according to a preferred embodiment. Figure 18A In the illustration, wound treatment product 1800 has been applied to the wound. Figure 18A The absorber core 1804 and the top layer 1820 are marked in the image.

[0154] exist Figure 18B In the middle, the absorbent core 1804 has absorbed a sufficient amount of exudate 1832.

[0155] exist Figure 18C , Figure 18D and Figure 18E In this process, the corners of the upper portion of the wound treatment product 1800 (including corner 1807 of the absorbent core 1804 and corner 1827 of the top layer 1820) have been gradually pulled up, thereby separating the upper portion, including the top layer 1820 and the absorbent core 1804, from the remaining contact membrane 1814 and skin substitute 1802 that are in contact with the wound. The contact surface 1821-1 of the inner layer 1821 of the top layer 1820 separates from the skin around the schematic wound, and the inner portion of the compliant foam layer 1806 separates from the top surface of the contact membrane 1814, exposing the remaining contact membrane 1814 and the skin substitute 1802 disposed beneath the remaining contact membrane 1804.

[0156] exist Figure 18F In this process, the upper portion, including the top layer 1820 and the absorbent core 1804, has been completely removed and discarded, leaving the remaining contact film 1804 exposed and the skin substitute 1802 arranged below the remaining contact film 1804.

[0157] Finally, Figure 18GIn this configuration, the upper portion 1850 of the wound treatment product for replacement is positioned above the remaining contact membrane 1804 and skin substitute 1802, similar to... Figure 15F The upper portion 1350 shown for replacement includes a new absorbent core 1804' and a new top layer 1820'. Particularly advantageously, this embodiment allows for replacement of the absorbent core of the wound care product without premature removal or replacement of the skin substitute in contact with the wound bed.

[0158] As described above, skin substitutes may be or may include decellularized dermal matrix typically in a dehydrated form. For example, in a preferred embodiment, the skin substitute or skin graft material is a decellularized dermal matrix comprising decellularized, freeze-dried fish skin. As a preferred and exemplary embodiment, the skin substitute may be a freeze-dried matrix product derived from whole decellularized fish skin, as described in U.S. Patent 8,613,957 B2, or even more preferably from lightly processed fish skin derived from Icelandic wild Atlantic cod. Because the skin substitute is in a dehydrated state, it preferably needs to be rehydrated before application. However, it should also be noted that the scaffold material used as a skin substitute does not necessarily need to be rehydrated. However, the inventors have found that in products where the skin substitute is bonded to an absorbent material (such as the absorbent core described herein), the rehydration of the dehydrated skin substitute material can sometimes be problematic.

[0159] To address this issue, this document proposes additional features and embodiments of wound treatment products or wound dressings that provide a hydration barrier between the skin substitute and the absorbent core, or between at least a portion of the skin substitute and the absorbent core. This hydration barrier can delay the flow of moisture, liquids, and / or vapors from the hydrated portion of the skin substitute to the absorbent core or at least a portion of the absorbent core. Preferably, the hydration barrier is a water-soluble, hydrolyzable, water-miscible, and / or water-sensitive barrier that does not immediately dissolve upon exposure to water but dissolves or decomposes over time upon continued exposure to water or other chemicals within the wound. While the aforementioned hydration barrier is water-soluble, hydration barriers of other components may also be used that can be decomposed, dissolved, removed, or altered upon exposure to chemicals within the wound environment during wound healing, but after the skin substitute bonded to the absorbent core has become hydrated. In another embodiment, the hydration barrier may be insoluble, but rather remains intact, partially intact, or substantially intact, configured to delay the flow of moisture, liquid, and / or vapor from the hydrated portion of the skin substitute to the absorbent core or at least a portion of the absorbent core. The hydration barrier may be a single-layer or multi-layer structure, such as a polymer monolayer or polymer multilayer structure. In another embodiment, the hydration barrier is a removable or modifiable single-layer or multi-layer structure or component, such as a micron or nanometer-scale valve array or porous structure, capable of delaying or preventing the flow of moisture, liquid, and / or vapor from the hydrated portion of the skin substitute to the absorbent core or at least a portion of the absorbent core. The hydration barrier may be configured to be removed or altered after the skin substitute has been hydrated, such that before and during hydration, the barrier layer delays or prevents the flow of moisture, liquid, and / or vapor from the hydrated portion of the skin substitute to the absorbent core or at least a portion of the absorbent core, while allowing moisture, liquid, and / or vapor to flow to the absorbent core after removal or alteration (e.g., manually removed by a practitioner).

[0160] Figure 19A , Figure 19B and Figure 19C Both illustrations show schematic diagrams of a wound treatment product 1900 according to another embodiment, which includes a non-limiting example of a hydration barrier. Figure 19A and Figure 19B In one embodiment, wound treatment product 1900 is a wound dressing that includes a complete skin substitute 1902 for supporting tissue regeneration (particularly skin regeneration) within the wound.

[0161] Wound management product 1900 includes a skin substitute 1902 and an absorbent core 1904. A hydration barrier 1950 is disposed between the skin substitute 1902 and the absorbent core 1904. The skin substitute 1902 is adhered to a contact layer or contact membrane 1914, which is also disposed between the skin substitute 1902 and the absorbent core 1904, allowing the hydration barrier 1950 to be disposed between the contact membrane 1914 and the absorbent core 1904. The absorbent core 1904 includes an compliant foam layer 1906 and an absorbent layer 1910 for absorbing and containing wound exudate. Wound management product 1900 includes a backing layer 1920, which, as a backing layer or top layer or top membrane, can be used to protect the underlying layers (1902, 1914, 1304) from damage and contamination, while also protecting the wound bed and the skin surrounding the wound. The backing layer 1920 is preferably a multilayer film, and in a preferred embodiment, includes an outer layer 1922 covering the inner layer 1921. The inner layer 1321 defines an unoccupied internal space 1923, such that the backing layer 1920 is provided with a recessed space 1923. That is, the inner layer 1921 removes a central portion at the space 1921, thus retaining only the edge portion. The wound treatment product 1900 also includes a release liner 1912 for aseptic handling of the wound treatment product 1900 before application to the wound site. The release liner 1912 preferably includes two portions 1912-1 and 1912-2 that meet and contact each other.

[0162] like Figure 19D As shown, the hydration barrier 1950 remains intact or substantially intact during the rehydration of the skin substitute 1902, such that after the release liner is removed and hydration is performed (e.g., by sprinkling, spraying, spitting, or other forms of hydration of the skin substitute), the water used to hydrate the skin substitute will not come into contact with the material of the absorbent core 1904, or due to the presence of the hydration barrier 1950, the water used to hydrate the skin substitute 1902 will at least not come into easy or substantial contact with the material of the absorbent core 1904. However, after the wound treatment product 1900' has been applied to the treated wound 1901, the hydration barrier 1950 can be removed or substantially removed by dissolving, breaking down, or otherwise, so that the absorbent core 1904' (especially the compliance layer 1906') can come into contact with the contact membrane 1914', and due to the adhesiveness provided by the contact membrane 1914' (especially due to the adhesiveness of the top surface of the top layer of the contact membrane 1914'), a lasting and effective contact can be maintained between the contact membrane 1914' and the compliance layer 1906' after the hydration barrier 1950 is dissolved.

[0163] like Figure 19DAs shown, the hydration barrier 1950 remains intact or substantially intact during the rehydration of the skin substitute 1902, such that after the release liner is removed and hydration is performed (e.g., by sprinkling, spraying, spitting, or other forms of hydration of the skin substitute), the water used to hydrate the skin substitute will not come into contact with the material of the absorbent core 1904, or due to the presence of the hydration barrier 1950, the water used to hydrate the skin substitute 1902 will at least not come into easy or substantial contact with the material of the absorbent core 1904. However, after the wound treatment product 1900' has been applied to the treated wound 1901, the hydration barrier 1950 can be removed or substantially removed by dissolving, breaking down, or otherwise, so that the absorbent core 1904' (especially the compliance layer 1906') can come into contact with the contact membrane 1914', and due to the adhesiveness provided by the contact membrane 1914' (especially due to the adhesiveness of the top surface of the top layer of the contact membrane 1914'), a lasting and effective contact can be maintained between the contact membrane 1914' and the compliance layer 1906' after the hydration barrier 1950 is dissolved.

[0164] Figure 20 shows a schematic diagram of a wound treatment product 2000 according to another embodiment. Figure 20A In one embodiment, wound treatment product 2000 is a wound dressing that includes a complete skin substitute 2002 for supporting tissue regeneration (particularly skin regeneration) within the wound.

[0165] Wound treatment product 2000 includes a skin substitute 2002 and an absorbent core 2004 bonded to the skin substitute. A contact layer or contact film 2014 is disposed between the skin substitute 2002 and the absorbent core 2004, such that the skin substitute 2002 and the absorbent core 2004 are in contact with opposite surfaces of the contact film 2014, respectively. The absorbent core 2004 includes an compliant foam layer 2006 and an absorbent layer 2010 for absorbing and containing wound exudate. Wound treatment product 2000 includes a backing layer 2020, which, as a backing layer or top layer or top membrane, can be used to protect the underlying layers (2002, 2014, 2004) from damage and contamination, while also protecting the wound bed and the skin surrounding the wound. The backing layer 2020 is preferably a multilayer film, and in a preferred embodiment, includes an outer layer 2022 covering an inner layer 2021. The inner layer 2021 defines an unoccupied internal space 2023, causing the backing layer 2020 to have a recess. That is, the inner layer 2021 removes the central portion at space 2021, thus retaining only the edge portion. The wound treatment product 2000 also includes a release liner 2012 for aseptic handling of the wound treatment product 2000 before application to the wound site. The release liner 2012 preferably comprises two portions 2012-1 and 2012-2 that meet and contact each other.

[0166] like Figure 20A As shown, the contact membrane 2014 has pores 2024, which are configured to allow wound exudate to pass through the contact membrane 2014 for absorption by the absorbent core 2004, and have similar characteristics to other pores that pass through the contact layer or contact membrane described herein. Figure 20A In one embodiment, the pores 2024 are filled with a barrier material 2055, which is similar to Figures 19A to 19C In the embodiments, the material of the hydration barrier 1950 is completely, substantially, or at least adequately filled to prevent water from penetrating the pores 2024 and being absorbed by the absorbent core 2004. After rehydration of the wound treatment product 2000, the wound treatment product 2000' is placed on the wound 2001. Upon exposure to the wound environment, the material 2055 of the hydration barrier 2055 is dissolved, decomposed, or otherwise removed, or substantially removed, to allow exudate from the wound to pass through the pores 2024' and be absorbed by the absorbent core 2004', particularly through the compliance layer 2010' and by the receiving layer 2010' of the absorbent core 2004'.

[0167] In another embodiment, such as Figure 21 As shown, the wound treatment product includes a barrier layer 2150 disposed between a skin substitute 2102 and an absorbent core 2104. Specifically, the barrier layer 2150 is disposed between a contact membrane 2114 and an accommodative layer 2106 of the absorbent core 2104. Furthermore, a barrier material 2155, having a similar or different composition from the barrier layer 2150, may be disposed in the pores 2124 of the contact membrane 2114, but which is also soluble or otherwise removable upon exposure to wound exudate over time. The combination of the barrier layer 2150 and the barrier material 2155 prevents or substantially prevents the absorption of water during the rehydration of the skin substitute 2102. However, the material of the barrier layer 2150 and the solubility or sensitivity of the barrier material 2155 allow the wound exudate to ultimately be absorbed by the absorbent core 2104.

[0168] Figure 22 A schematic diagram of a wound treatment product 2200 according to another embodiment is shown. Figure 22 In one embodiment, wound treatment product 2200 is a wound dressing that includes an intact skin substitute 2202 for supporting tissue regeneration (particularly skin regeneration) within the wound.

[0169] Wound treatment product 2200 and Figures 19A to 19CThe difference in this embodiment is that a barrier layer 2250 is disposed between the skin substitute 2202 and the contact membrane 2214. That is, the wound treatment product 2200 includes a skin substitute 2202 and an absorbent core 2204. The hydration barrier 2250 is disposed between the skin substitute 2202 and the contact membrane 2214. The absorbent core 2204 includes an compliant foam layer 2206 and an absorbent layer 2210 for absorbing and containing wound exudate. The wound treatment product 2200 includes a backing layer 2220, which, as a backing layer or top layer or top membrane, can be used to protect the layers below (2202, 2214, 2204) from damage and contamination, while also protecting the wound bed and the skin surrounding the wound. The backing layer 2220 is preferably a multilayer membrane, and in a preferred embodiment, includes an outer layer 2222 covering an inner layer 2221. Similar to other embodiments, the wound treatment product 2200 also includes a release liner 2212 for aseptic handling of the wound treatment product 2200 before application to the wound site.

[0170] During the rehydration of the skin substitute 2202, the hydration barrier 2250 remains intact or substantially intact, so that after the release liner is removed and hydration is performed (e.g., by sprinkling, spraying, spitting, or other forms of hydration of the skin substitute), the water used to hydrate the skin substitute will not come into contact with the material of the absorbent core 2204, or the presence of the hydration barrier 2250 will prevent the water used to hydrate the skin substitute 2202 from easily or substantially coming into contact with the material of the absorbent core 2204. However, after the wound treatment product 2200 is applied to the treated wound, the hydration barrier 2250 can be dissolved, broken down, or otherwise removed, or substantially removed, so that the skin substitute 2202 can come into contact with the contact membrane 2214. And due to the adhesiveness provided by the contact membrane 2214 (especially due to the adhesiveness of the bottom surface of the bottom layer of the contact membrane 2214), after the hydration barrier 2250 is dissolved, the contact membrane 2214 can establish a lasting and effective contact with the skin substitute 2202, especially due to the force exerted by the compliance layer 2206.

[0171] During the rehydration of the skin substitute 2202, the hydration barrier 2250 remains intact or substantially intact, such that after the release liner is removed and hydration is performed (e.g., by sprinkling, spraying, spitting, or other forms of hydration of the skin substitute), the water used to hydrate the skin substitute will not come into contact with the material of the absorbent core 2204, or the presence of the hydration barrier 2250 will prevent the water used to hydrate the skin substitute 2202 from easily or substantially coming into contact with the material of the absorbent core 2204. However, after the wound treatment product 2200 is applied to the treated wound, the hydration barrier 2250 may be dissolved, broken down, or otherwise removed, or substantially removed, and exudate from the wound may pass through the pores in the contact membrane 2214 and be absorbed by the absorbent core 2204.

[0172] As described herein, the barrier layer and barrier material can be made of or composed of a variety of materials. In a preferred embodiment, the barrier material of the barrier layer or the barrier material within the pores of the contact membrane can be water-soluble, water-degradable, or water-sensitive. The barrier material of the barrier layer and the barrier material disposed within the pores of the contact membrane constitute a sacrificial moisture barrier, serving as a coating or “mask” between the foam layers of the absorbent core. The materials of the barrier layer and barrier material are biocompatible with the wound or harmless to wound healing. Such materials may include, but are not limited to: gelatin, fish gelatin, denatured collagen, biocompatible polymer materials, starch, collagen, water-soluble carrageenan, pectin, xanthan gum, guar gum, or other gums, or combinations thereof. The key to a hydration barrier material is that it is not dissolved in water very rapidly; it dissolves or otherwise decomposes or substantially decomposes during the hydration of the skin substitute, thereby allowing the water used to hydrate the skin substitute to come into contact or substantially contact with the absorbent core. The thickness, density, and extent of the barrier layer are affected by its durability, thereby controlling the residence time between hydration of the skin substitute and the arrival of water in the absorbent core foam. Alternatively, and preferably, the hydration barrier may be disposed only in the pores or openings of the polyurethane material of the contact layer, thereby allowing the silicone adhesive layer to contact the foam layer and the skin substitute separately, without altering the adhesion between the composite layers during hydration. In other embodiments, the hydration barrier may encapsulate a substantial portion of the product to further protect the absorbent core foam layer from moisture contact during the hydration of the skin substitute.

[0173] In addition, other materials may be considered, even if they are insoluble in water or sensitive to water, but which will be broken down, removed, or substantially decomposed when exposed to chemicals, solvents, or enzymes in the wound environment or wound exudate.

[0174] Those skilled in the art, upon seeing this invention, can make various alterations and / or modifications to the features of the invention described herein in the disclosed embodiments, and can make other applications to the principles described herein in the disclosed embodiments without departing from the spirit and scope of the invention as defined by the claims, and such applications are considered to be within the scope of the invention. Therefore, although several aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. While embodiments of the invention can be practiced using many methods and components similar to or equivalent to those described herein, only certain components and methods are described herein.

[0175] Composability of embodiments and features

[0176] This invention provides various examples, embodiments, and features for wound treatment products, kits, systems, and methods. Unless explicitly stated otherwise, or unless such examples, embodiments, and features are mutually exclusive, the various examples, embodiments, and features disclosed herein should be understood as being able to be combined with other examples, embodiments, or features described herein.

[0177] It should be understood that systems, apparatuses, products, kits, methods, and / or processes according to certain embodiments of the present invention may also include, incorporate, or contain the attributes and features (e.g., components, members, elements, parts, and / or portions) described in other embodiments disclosed and / or described herein. Therefore, various features of certain embodiments may be compatible with, combined with, included in, and / or incorporated into other embodiments of the invention. Consequently, the disclosure of certain features with respect to a particular embodiment of the invention should not be construed as limiting the application or inclusion of said features to that particular embodiment. Rather, it should be understood that other embodiments may also include said features, members, elements, parts, and / or portions without departing from the scope of the invention.

[0178] Furthermore, unless a feature is described as requiring another feature to be combined with it, any feature herein may be combined with any other feature of the same or different embodiments disclosed herein. Additionally, various well-known aspects of exemplary systems, methods, apparatuses, etc., are not described in detail herein to avoid obscuring aspects of the exemplary embodiments. However, such aspects are also included within the scope of this document.

[0179] It should be understood that an embodiment of the invention does not necessarily achieve all objectives or advantages. Those skilled in the art will understand that wound treatment products and methods of manufacturing thereof may achieve or optimize only one or a set of advantages taught herein, without necessarily achieving other objectives or advantages taught or implied herein.

[0180] Composability of embodiments and features

[0181] This invention provides various examples, embodiments, systems, products, and methods for wound treatment. In addition to the above disclosure, other embodiments and examples may also include the following groups and enumerated embodiments.

[0182] Group 1 – A wound treatment product, or in other words, a wound dressing, and corresponding kits and methods.

[0183] 1-1. A wound treatment product comprising: a skin substitute configured to contact a wound; a contact membrane configured to contact the skin substitute and situated between an absorbent core and the skin substitute; and a replaceable portion covering the contact membrane, the replaceable portion including an absorbent core configured to absorb wound exudate and a top membrane covering the absorbent core such that the absorbent core is situated between the contact membrane and the top membrane, wherein the replaceable portion is separable from the contact membrane, thereby allowing the replaceable portion to be removed from the contact membrane without damaging or removing the skin substitute.

[0184] 1-2. The wound care product according to any one or a combination of 1-1 above and / or 1-3 to 1-31 below, wherein the absorbent core includes a conforming foam layer for conforming to the shape of the wound bed.

[0185] 1-3. The wound treatment product according to any one or a combination of 1-1 to 1-2 above and / or 1-4 to 1-31 below, wherein the skin substitute comprises acellular dermal matrix containing acellular fish skin.

[0186] 1-4. The wound treatment product according to any one or a combination of 1-1 to 1-3 above and / or 1-5 to 1-31 below, wherein the skin substitute comprises decellularized fish skin.

[0187] 1-5. The wound treatment product according to any one or a combination of 1-1 to 1-4 above and / or 1-6 to 1-31 below, wherein the skin substitute comprises lipids from the lipid layer of decellularized fish skin.

[0188] 1-6. The wound treatment product according to any one or a combination of 1-1 to 1-5 above and / or 1-7 to 1-31 below, wherein the skin substitute comprises an extracellular matrix product in a three-dimensional form, in the form of granules, sheets or meshes.

[0189] 1-7. The wound treatment product according to any one or a combination of 1-1 to 1-6 above and / or 1-8 to 1-31 below, wherein the contact film is a multilayer film comprising a core layer, a first outer layer disposed on a first surface of the core layer and a second outer layer disposed on a second surface of the core layer, the first surface of the core layer being opposite to the second surface of the core layer, the first outer layer being in contact with and removably adhered to a skin substitute, and the second outer layer being in contact with an absorbent core.

[0190] 1-8. The wound treatment product according to any one or a combination of 1-1 to 1-7 above and / or 1-9 to 1-31 below, wherein the first outer layer is a silicone adhesive layer.

[0191] 1-9. The wound treatment product according to any one or a combination of 1-1 to 1-8 above and / or 1-10 to 1-31 below, wherein the second outer layer is another silicone adhesive layer.

[0192] 1-10. The wound treatment product according to any one or a combination of 1-1 to 1-9 above and / or 1-11 to 1-31 below, wherein the core layer of the contact membrane is made of polyethylene terephthalate (PET).

[0193] 1-11. The wound treatment product according to any one or a combination of 1-1 to 1-10 above and / or 1-12 to 1-31 below, wherein the absorbent core further comprises an absorbent layer.

[0194] 1-12. The wound treatment product according to any one or a combination of 1-1 to 1-11 above and / or 1-13 to 1-31 below, wherein the contact membrane has a predetermined porosity.

[0195] 1-13. The wound treatment product according to any one or a combination of 1-1 to 1-12 above and / or 1-14 to 1-31 below, wherein the predetermined porosity defines the pore distribution over the surface area of ​​the contact membrane.

[0196] 1-14. The wound treatment product according to any one or a combination of 1-1 to 1-13 above and / or 1-15 to 1-31 below, wherein the skin substitute has an open structure.

[0197] 1-15. The wound treatment product according to any one or a combination of 1-1 to 1-14 above and / or 1-16 to 1-31 below, wherein the absorbent layer comprises a superabsorbent polymer.

[0198] 1-16. The wound treatment product according to any one or a combination of 1-1 to 1-15 above and / or 1-17 to 1-31 below, wherein the absorbent core includes microcapillaries adapted to promote vertical absorption of wound exudate.

[0199] 1-17. The wound treatment product according to any one or a combination of 1-1 to 1-16 above and / or 1-18 to 1-31 below, wherein the top membrane comprises an outer layer and an inner layer, the outer layer covering the inner layer, wherein the inner layer defines a central space through which the inner surface of the outer layer can contact the absorbent core.

[0200] 1-18. The wound treatment product according to any one or a combination of 1-1 to 1-17 above and / or 1-19 to 1-31 below, wherein the contact surface of the inner layer is configured to contact the skin surrounding the wound bed.

[0201] 1-19. The wound treatment product according to any one or a combination of 1-1 to 1-18 above and / or 1-20 to 1-31 below, wherein the outer layer of the top membrane adheres to the absorbent layer of the absorbent core.

[0202] 1-20. The wound treatment product according to any one or a combination of 1-1 to 1-19 above and / or 1-21 to 1-31 below, wherein a silicone adhesive is provided on the contact surface of the inner layer of the top membrane.

[0203] 1-21. The wound treatment product according to any one or a combination of 1-1 to 1-20 above and / or 1-22 to 1-31 below, wherein a silicone adhesive is provided on the contact surface of the inner layer of the top membrane, the silicone adhesive being configured to removably adhere the inner layer to the skin surrounding the wound bed.

[0204] 1-22. The wound treatment product according to any one or a combination of 1-1 to 1-21 above and / or 1-23 to 1-31 below, wherein the top membrane is impermeable to liquids but permeable to vapors.

[0205] 1-23. The wound treatment product according to any one or a combination of 1-1 to 1-22 above and / or 1-24 to 1-31 below, wherein the top membrane is airtight and adapted to form a seal around the wound bed.

[0206] 1-24. The wound treatment product according to claim 1 further includes a barrier layer disposed between the skin substitute and the absorbable core.

[0207] 1-25. The wound treatment product according to any one or a combination of 24 above and / or 26-31 below, wherein the barrier layer is disposed between the contact membrane and the absorbent core.

[0208] 1-26. The wound treatment product according to any one of 1-24 to 1-25 above or 1-27 to 1-31 below, wherein the barrier layer is disposed between the contact membrane and the skin substitute.

[0209] 1-27. The wound treatment product according to any one of 1-24 to 1-26 above or 1-28 to 1-31 below, wherein the barrier layer comprises a barrier material disposed within pores penetrating the contact membrane.

[0210] 1-28. The wound treatment product according to any one of 1-24 to 1-27 above or 1-29 to 1-31 below, wherein the barrier layer comprises a water-soluble, water-degradable, water-miscible, and / or water-sensitive material.

[0211] 1-29. The wound treatment product according to any one of 1-24 to 1-28 above or 1-30 to 1-31 below, wherein the barrier layer comprises gelatin.

[0212] 1-30. The wound treatment product according to 1-24, wherein the barrier layer comprises a material that is readily decomposed upon exposure to wound exudate or the wound environment.

[0213] 1-31. The wound treatment product according to 30, wherein the barrier layer comprises a material that is insoluble in water.

[0214] 1-32. A negative pressure wound therapy device comprising a wound treatment product according to any one of or a combination of 1-1 to 1-31 above.

[0215] 1-33. A pre-packaged kit comprising a wound treatment product according to any one of 1-1 to 1-31 above, or a combination thereof, wherein the wound treatment product is disposed within sterile packaging material.

[0216] 1-34. A method of treating a wound by applying a wound treatment product according to any one of 1-1 to 1-31 or a combination thereof to a wound bed.

[0217] 1-35. The method of treating a wound according to 1-34 above further includes removing a replaceable portion of the wound treatment product after a period of time, the replaceable portion including an absorbent core and a top membrane, and leaving the remaining portion intact on the wound bed, the remaining portion including a contact membrane and a skin substitute.

[0218] 1-36. The method according to 35 above further includes providing a second replaceable portion on the remaining portion, the second replaceable portion including a second absorbent core configured to further absorb wound exudate and a second top membrane covering the second absorbent core, such that the second absorbent core is disposed between the contact membrane and the second top membrane.

[0219] Group 2 – Another wound care product, or in other words, a wound dressing, and corresponding kits and methods.

[0220] 2-1. A wound treatment product comprising: a skin substitute; an absorbent core bonded to the skin substitute; wherein the absorbent core includes a conforming foam layer for conforming to the shape of a wound bed.

[0221] 2-2. The wound treatment product according to any one or a combination of 2-1 above and / or 2-3 to 2-22 below, wherein the skin substitute comprises acellular dermal matrix containing acellular fish skin.

[0222] 2-3. The wound treatment product according to any one or a combination of 2-1 to 2-2 above and / or 2-4 to 2-22 below, wherein the skin substitute comprises decellularized fish skin.

[0223] 2-4. The wound treatment product according to any one or a combination of 2-1 to 2-3 above and / or 2-5 to 2-22 below, wherein the skin substitute comprises lipids from the lipid layer of decellularized fish skin.

[0224] 2-5. The wound treatment product according to any one or a combination of 2-1 to 2-4 above and / or 2-6 to 2-22 below, wherein the skin substitute comprises an extracellular matrix product in a three-dimensional form, in the form of particles, sheets or meshes.

[0225] 2-6. The wound care product according to any one or a combination of 2-1 to 2-5 above and / or 2-7 to 2-22 below further includes a polymer contact layer, wherein the polymer contact layer is integrally bonded to the absorbent core and removably adhered to the skin substitute.

[0226] 2-7. The wound treatment product according to any one or a combination of 2-1 to 2-6 above and / or 2-8 to 2-22 below, wherein the absorbent core further comprises a receiving layer.

[0227] 2-8. The wound treatment product according to any one or a combination of 2-1 to 2-7 above and / or 2-9 to 2-22 below, wherein the polymer contact layer has a predetermined porosity.

[0228] 2-9. The wound treatment product according to any one or a combination of 2-1 to 2-8 above and / or 2-10 to 2-22 below, wherein the predetermined porosity defines the pore distribution over the surface area of ​​the polymer contact layer.

[0229] 2-10. The wound treatment product according to any one or a combination of 2-1 to 2-9 above and / or 2-11 to 2-22 below, wherein the receiving layer comprises a superabsorbent polymer.

[0230] 2-11. The wound treatment product according to any one or a combination of 2-1 to 2-10 above and / or 2-12 to 2-22 below, wherein the absorbent core includes microcapillaries adapted to promote vertical absorption of wound exudate.

[0231] 2-12. The wound treatment product according to any one or a combination of 2-1 to 2-11 above and / or 2-13 to 2-22 below, wherein each microcapsule includes a vertical channel and a lateral capsule.

[0232] 2-13. The wound care product according to any one or a combination of 2-1 to 2-12 above and / or 2-14 to 2-22 below, wherein the absorbent core includes at least one cavity for receiving at least one skin substitute portion to mechanically attach the skin substitute to the absorbent core.

[0233] 2-14. The wound care product according to any one or a combination of 2-1 to 2-13 above and / or 2-15 to 2-22 below, further comprising sutures for mechanically attaching a skin substitute to an absorbable core.

[0234] 2-15. The wound care product according to any one or a combination of 2-1 to 2-14 above and / or 2-16 to 2-22 below, wherein the suture is biodegradable and adapted to dissolve after a period of time to allow skin substitutes to separate from the absorbent core.

[0235] 2-16. The wound treatment product according to 2-1 further includes a barrier layer disposed between the skin substitute and the absorbable core.

[0236] 2-17. The wound treatment product according to any one or a combination of 2-16 above and / or 2-18 to 2-22 below, wherein the barrier layer is disposed between the contact membrane and the absorbent core.

[0237] 2-18. The wound treatment product according to any one or a combination of 2-16 to 2-17 above and / or 2-19 to 2-22 below, wherein the barrier layer is disposed between the contact membrane and the skin substitute.

[0238] 2-19. The wound treatment product according to any one or a combination of 2-16 to 2-18 above and / or 2-20 to 2-22 below, wherein the barrier layer comprises a barrier material disposed within pores penetrating the contact membrane.

[0239] 2-20. The wound treatment product according to any one or a combination of 2-16 to 2-19 above and / or 2-21 to 2-22 below, wherein the barrier layer comprises a water-soluble, water-degradable, water-miscible, and / or water-sensitive material.

[0240] 2-21. The wound treatment product according to any one or a combination of 2-16 to 2-20 and / or 2-22 above, wherein the barrier layer comprises gelatin.

[0241] 2-22. The wound treatment product according to 2-21, wherein the barrier layer comprises a material that is easily decomposed when exposed to wound exudate or the wound environment.

[0242] 2-23. A negative pressure wound therapy device comprising a wound treatment product according to any one of or a combination of 2-1 to 2-22 above.

[0243] 2-24. The wound treatment product according to any one of 2-1 to 2-22 above, or a combination thereof, wherein the wound treatment product includes a backing layer.

[0244] 2-25. The wound treatment product according to any one of or a combination of 2-1 to 2-22 above, wherein the backing layer is impermeable to liquids but permeable to vapors.

[0245] 2-26. The wound treatment product according to any one of or a combination of 2-1 to 2-22 above, wherein the backing layer is airtight and adapted to form a seal around the wound bed.

[0246] 2-27. A pre-packaged kit comprising a wound treatment product according to any one of 2-1 to 2-22 above, or a combination thereof, wherein the wound treatment product is disposed within sterile packaging material.

[0247] 2-28. A method of treating a wound by applying a wound treatment product according to any one of 2-1 to 2-22 or a combination thereof to a wound bed.

[0248] Those skilled in the art will understand that some of the various disclosed features are interchangeable. In addition to the variations described herein, those skilled in the art can mix and match other known equivalents of the various features to construct wound treatment products and methods of manufacturing thereof based on the principles of this invention.

[0249] While this invention describes certain exemplary embodiments and examples of wound care products, those skilled in the art will understand that the invention can be extended from the specifically disclosed embodiments of wound care products to other alternative embodiments and / or uses of the invention, as well as obvious modifications and equivalents. The invention should not be limited to the embodiments disclosed above and can be extended to other applications that may employ the features described herein. It should be understood that the embodiments described above are illustrative in nature and can be modified by those skilled in the art. Therefore, the invention should not be considered limited to the embodiments disclosed herein, but should be defined only by the appended claims.

Claims

1. A wound treatment product, comprising: Skin substitutes; An absorbent core, to which the skin substitute is bonded; The absorbent core includes a conformable foam layer to conform to the shape of the wound bed.

2. The wound treatment product according to claim 1, characterized in that, The skin substitute includes decellularized fish skin.

3. The wound treatment product according to claim 1 or 2, characterized in that, The skin substitutes include extracellular matrix products in three-dimensional forms, such as granules, sheets, or meshes.

4. The wound treatment product according to any one of claims 1 to 3, characterized in that, It also includes a polymer contact layer, wherein the polymer contact layer is integrally bonded to the absorbent core and removably adhered to the skin substitute.

5. The wound treatment product according to any one of claims 1 to 4, characterized in that, The absorber core also includes a receiver layer.

6. The wound treatment product according to claim 4 or 5, characterized in that, The polymer contact layer has a predetermined porosity.

7. The wound treatment product according to claim 6, characterized in that, The predetermined porosity defines the pore distribution over the surface area of ​​the polymer contact layer.

8. The wound treatment product according to claim 5, characterized in that, The receiving layer comprises a superabsorbent polymer.

9. The wound treatment product according to claim 8, characterized in that, The absorbent core includes microcapillaries adapted to facilitate vertical absorption of wound exudate.

10. The wound treatment product according to any one of claims 1 to 9, characterized in that, The wound treatment product includes a backing layer configured such that the absorbent core is located between the contact membrane and the backing layer, wherein the backing layer is impermeable to liquids but permeable to vapors, and wherein the backing layer is adapted to form a seal around the wound bed.

11. The wound treatment product according to any one of claims 1 to 10, characterized in that, The wound treatment product includes a hydration barrier located between the skin substitute and the absorbent core, or between the skin substitute and at least a portion of the absorbent core, wherein the hydration barrier delays the flow of moisture, liquid, or vapor from the hydrated portion of the skin substitute to the absorbent core or the at least a portion of the absorbent core.

12. A negative pressure wound therapy device, comprising the wound treatment product according to any one of claims 1 to 11.

13. A pre-packaged kit comprising a wound treatment product according to any one of claims 1 to 11, wherein the wound treatment product is disposed within sterile packaging material.

14. A wound treatment method, the method comprising: Provide a wound treatment product according to any one of claims 1 to 11, and Apply the wound treatment product to the wound bed.

15. A wound treatment product, comprising: Skin substitutes, designed to be placed in contact with the wound surface; A contact membrane, configured to contact the skin substitute and located between the absorbent core and the skin substitute; as well as A replaceable portion covering the contact membrane, the replaceable portion including an absorbent core configured to absorb wound exudate, and a top membrane covering the absorbent core, such that the absorbent core is disposed between the contact membrane and the top membrane; The replaceable portion is separable from the contact membrane, thereby allowing the replaceable portion to be removed from the contact membrane without damaging or removing the skin substitute.

16. The wound treatment product according to claim 15, characterized in that, The absorbent core includes a conformable foam layer to conform to the shape of the wound bed.

17. The wound treatment product according to claim 15, characterized in that, The skin substitute comprises a decellularized dermal matrix containing decellularized fish skin.

18. The wound treatment product according to claim 15, characterized in that, The skin substitutes include extracellular matrix products in three-dimensional forms, such as granules, sheets, or meshes.

19. The wound treatment product according to claim 15, characterized in that, The contact film is a multilayer film comprising a core layer, a first outer layer disposed on a first surface of the core layer, and a second outer layer disposed on a second surface of the core layer, wherein the first surface of the core layer is opposite to the second surface of the core layer, the first outer layer is in contact with the skin substitute and is removably adhered to it, and the second outer layer is in contact with the absorbent core.

20. The wound treatment product according to claim 18, characterized in that, The first outer layer is a silicone adhesive layer.

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