WO2021140466A1

WO2021140466A1 - Wound sealing film

Info

Publication number: WO2021140466A1
Application number: PCT/IB2021/050099
Authority: WO
Inventors: Timothy Mark Robinson; James Seddon; Justin Rice
Original assignee: Kci Licensing, Inc.
Priority date: 2020-01-07
Filing date: 2021-01-07
Publication date: 2021-07-15

Abstract

This disclosure describes a wound sealing film containing a first layer having a first surface and a second surface, said first layer contains a first polymer composition, a second layer having a first surface and a second surface, said second layer contains a polymeric gel, and a third layer having a first surface and a second surface, said third layer contains an adhesive, wherein the second layer is positioned between the first layer and the third layer, method of making and using the wound sealing film.

Description

WOUND SEALING FILM

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/958,119, filed on January 7, 2020, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] Aspects of the present disclosure relate generally to a compound film. In particular, the invention concerns a composite film containing a first polymer layer, a second gel layer and an third adhesive layer, system and method for forming the compound film and method of using the compound film for a dressing of a wound therapy system.

BACKGROUND

[0003] Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome. Treatment of wounds or other tissue with reduced pressure may be commonly referred to as "negative-pressure therapy," but is also known by other names, including "negative-pressure wound therapy," "reduced-pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative-pressure," for example. Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times. Efficient sealing between the wound covering and a patient skin is desirable for negative pressure therapy.

SUMMARY

[0004] This disclosure describes a medical drape with a lower leak rate and higher moisture vapor transmission rate of other commercially available low leak medical drapes. Non-limiting uses of the medical drape include sealing of a wound, securing another medical device, dressing, or drape, and/or in a pressure wound therapy treatment. In some aspects, the pressure wound therapy treatment can be negative pressure wound therapy treatment. In some aspects, the pressure wound therapy treatment can be positive pressure wound therapy treatment. Not to be bound by theory, it is believed that the placement of a gel layer between a polymeric film, such as a gas impermeable film, and an adhesive may decrease leaks in the seal of the drape by filling in gaps, wrinkles, or punctures in the sealing film. [0005] Certain embodiments are directed to a wound sealing film. The wound sealing film can include a first layer containing a first polymer, a second layer containing a polymeric gel and a third layer containing an adhesive. The second layer can be positioned between the first layer and the third layer. The first layer can have a first surface and a second surface. The second layer can have a first surface and a second surface. The third layer can have a first surface and a second surface. In some aspects, the second surface of the first layer can be in contact with the first surface of the second layer. In some aspects, the second surface of the second layer can be in contact with the first surface of the third layer. [0006] The second layer can contain a plurality of perforations through, or partially through, the second layer. The plurality of perforations can contain perforations of any suitable shape and size. In some aspects, the plurality of perforations can contain perforations of similar shape and/or size. In some aspects, the plurality of perforations can contain perforations of different shape and/or size. Non limiting perforation shapes include, circular, oval, elliptical, square, rounded square, rectangular, rounded rectangular, pentagonal, rounded pentagonal, hexagonal, rounded hexagonal, heptagonal, rounded heptagonal, octagonal, rounded octagonal, star shaped, rounded star shaped, rod shaped or an irregular shape. In some aspects, the plurality of perforations of the second layer can have an average cross- sectional length of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 mm, or any range thereof or length therein. In some instances, the average cross-sectional length is about 2 mm to about 50 mm, or about 5 mm to about 35 mm, or about 5 mm to about 20 mm, or about 5 mm to about 10 mm. In some aspects, the plurality of perforations of the second layer can contain adjacent perforations having centers separated by 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, or 120 mm, or any range thereof or length therein. In some instances, the average length of separation of the centers is 5 mm to 100 mm, or 10 mm to 70 mm, or 10 mm to 50 mm. In some aspects, the second layer forms ribs defining the perforations, and the ribs have an average cross-section length parallel to the first surface and/or second surface of the second layer of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 mm, or any range thereof or length therein. In some instances, the average cross-sectional length is between 1 to 6 mm. In some aspects, the plurality of perforations of the second layer can form a web like pattern. In some aspects, the plurality of perforations of the second layer can form a repetitive pattern. In some aspects, the plurality of perforations of the second layer forms 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 98, 99% or any range thereof or percent therein of the surface area of the second layer based on the length and width of the second layer. In some instances, the plurality of perforations of the second layer forms 25% to 98 % of the surface area of the second layer based on the length and width of the second layer. In some aspects, the surface area of the second layer can be the area of the first and/or second surface of the second layer.

[0007] In some aspects, the third layer can contain a plurality of perforations. In some aspects, at least a portion of the plurality of perforations of the third layer can align with at least a portion of the perforations of the second layer. In some instances, all of the plurality of perforations of the third layer align with the perforations of the second layer. [0008] The first polymer of the first layer can be polyurethane, polyethylene, cellulosics, polyamides, polyvinyl alcohol, polyvinyl pyrrolidone, acrylics, silicone elastomers, or any combination thereof. In some aspects, the first polymer can be polyurethane. In some aspects, the first layer can be 0.01, 0.02, 0.04, 0.06, 0.08, 0.1, 0.12, 0.14, 0.16, 0.18, 0.2 mm, or any range thereof or thickness therein thick. In some instances, the average thickness is 0.02 mm to 0.12 mm thick. In some aspects, the first layer can have a real weight of 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, or 120 grams per square meter (gsm) or any range thereof or weight therein. In some instances, the average areal weight is 30 to 100 (gsm).

[0009] In some aspects, the polymeric gel of the second layer contains a polyurethane gel, a hydrogel, a silicone gel, a hydrocolloid, a hydrocolloid rubber-based system, or any combination thereof. In some aspects, the polymeric gel can be tacky or a second adhesive. The polymeric gel can in some instances be a light switchable second adhesive, such as one that decreases in tackiness when exposed to light, such as ultraviolet light. In some aspects, the polymeric gel of the second layer contains styrene- isoprene-styrene terpolymer, polyisobutylenes, ethylene -vinyl acetates (EVA)s, ethylene propylene rubber (EPM), or ethylene propylene diene monomer rubber (EPDM). The polymeric gel of the second layer can contain thermoplastic elastomers such as poly(styrene-butadiene-styrene) SEBs. In some aspects, the polymeric gel of the second layer can contain a hydrocolloid. In some aspects, the hydrocolloid can include, a polymer, a first particle containing a water absorbing compound; and optionally a plasticizer. In some aspects, the first particle can be dispersed in a matrix of the polymer. In some aspects, the water absorbing compound can be carboxymethyl cellulose, starch, alginates, and/or superabsorbent such as those based on acrylics and acrylic-sulfonic acid polymers, and/or a salt thereof. In some aspects, the salt thereof can be a sodium, potassium, calcium and/or magnesium salt. In some aspects, the polymer can be a water sensitive polymer. In some particular aspects, the water sensitive polymer can contain starch, acrylic polymers, acrylic-sulphonic acid polymers such as 2- acrylamido-2-methylpropane sulfonic acid, pectin, carrageenan, gelatin, and/or alginate. In some aspect, the polymer can be a water non-sensitive polymer. In some particular aspects, the water non sensitive polymer can contain an isoprene polymer, polyisobutylene, ethylene-propylene copolymer, ethylene propylene diene monomer (EPDM) copolymer, a styrene-ethylene-butene-styrene (SEBS) block polymer, an isoprene isobutene copolymer, a styrene-isoprene-styrene copolymer such as styrene- isoprene-styrene terpolymers, or an ethylene vinyl acetate copolymer. A water sensitive polymer is a polymer that is chemically or physically changed when contacting water at standard pressure and 37 °C. A water non-sensitive polymer is a polymer that is not physically or chemically changed when contacting water at standard pressure and 37 °C. In some aspects, the plasticizer can be a paraffinic plasticizer, a naphthenic plasticizer, a petroleum jelly, an amorphous alpha olefin, a natural oil, or any combination thereof. In some aspects, the paraffinic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to 50 carbon atoms long. In some aspects, the paraffinic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to 50 carbon atoms long, the saturated hydrocarbon chains can contain areas that can crystalize (wax). In some aspects, the paraffinic plasticizer can be aromatic-free paraffinic white mineral oils. In some aspects, the paraffinic plasticizer can be paraffinic process oils. In some aspects, the paraffinic plasticizer can be paraffinic process oils manufactured via the solvent extraction process. In some aspects, the paraffinic plasticizer can be refined hydrotreated paraffinic process oils. In some aspects, the paraffinic plasticizer can be refined hydrotreated paraffinic process oils and are essentially colorless and sulfur free. In some aspects, the naphthenic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to 50 carbon atoms long and contain cyclic or ring structures. In some aspects, the amorphous alpha olefin can be atactic polypropylene. In some aspects the natural oil can be linseed oil, soybean oil, tall oil or any combination thereof. Paraffinic plasticizers that are useful in the current invention include but are not limited to paraffinic plasticizers commercially available under the brand name SHELL ONDINA OILS (15, 32, 46, 919, 941, X415, X420, X430, X432) and SHELL CATENEX OIL sold by SHELL. Naphthenic plasticizer that are useful in the current invention includes but are not limited to naphthenic plasticizers commercially available under the brand name SHELL EDELEX OIL sold by SHELL. [0010] In some aspects, the hydrocolloid can include the water sensitive polymer and the first particle. In some aspects, the hydrocolloid can include the water non-sensitive polymer, the first particle and the plasticizer. In some aspects, the hydrocolloid can include the water sensitive polymer, the non-sensitive polymer, the first particle and optionally a plasticizer. In some aspects, the second layer can have a water absorption rate of 0.1, 0.2, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 g/g, or any range thereof or rate therein. In some instances, the rate is 0.5 g/g to 5 g/g. The second layer can have a dry adhesive strength of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 N/25 cm or any range thereof or strength therein. In some instances, the strength is 5 N/25 cm to 15 N/25 cm. The second layer can have a density of 0.4, 0.6, 0.8, 0.1, 0.12, 0.14, 0.16, 0.18, 0.2 g/cc or any range thereof or density therein. In some instances, the density is 0.9 g/cc to 1.5 g/cc. In some aspects, the second layer can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2 mm, or any range thereof or thickness therein thick. In some instances, the average thickness is 0.1 mm to 1.2 mm thick. In some aspects, the second layer can have a hardness of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80 Shore 00 or any range thereof or hardness therein. In some instances, the average hardness is 10 to 50 Shore 00. In some aspects, the second layer can be a transparent layer.

[0011] The adhesive of the third layer can be a high tack adhesive and/or light-switchable adhesive. In some instances, the adhesive is an acrylic adhesive. In some instances, the adhesive is a high tack acrylic adhesive. In some instances, the adhesive is a high tack acrylic lumina adhesive. In some aspects, the third layer can be 0.005, 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2 mm, or any range thereof or thickness therein thick. In some instances, the average thickness is 0.01 mm to 1 mm thick. In some aspects, the third layer can have an areal weight of 100 to 250 grams per square meter (gsm). In some aspects, the third layer can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m²/24 hours. In some aspects, the third layer can have a viscosity which produces 7 mm to 11 mm of cone penetration according to ISO 2137 (e.g., 70 mm/10 to 110 mm/ 10).

[0012] In some aspects, the wound sealing film can further include a first cover layer. The first cover layer can be removably attached to the first surface of the first layer. In some aspects, the first cover layer can be a light blocking layer. In some particular aspects, the adhesive of the third layer can be a light-switchable adhesive and the first cover layer can be a light blocking layer. In some aspects, the wound sealing film can further include a second cover layer. The second cover layer can be removably attached to the second surface of the third layer. In some aspects, the second cover layer can be a light blocking layer. In some particular aspects, the adhesive of the third layer can be a light-switchable adhesive and the second cover layer can be a light blocking layer.

[0013] The wound sealing film can be or can be included in a drape, a bandage, a wound closure device, a therapy system, an adhesive, and/or a negative-pressure therapy system. The second surface of the third layer can be configured to contact a skin of a subject during use of the wound sealing film to seal a wound of the subject. In some aspects, the second cover layer can be removed from the second surface of the third layer prior to contacting the second surface of the third layer with the skin of the subject.

[0014] In some aspects, the wound sealing film can have a moisture vapor transmission rate (MVTR) of 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1100, 1200, 1300, 1400, 1500, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 6500, 7000, 7500, 8000, 8500, 9000, 9500, 10000, 11000, 12000, 13000, 14000, 15000, 16000, 17000, 18000 g/m²/24 hours, or any range thereof or rate therein. In some instances, the average rate is 200 g/m²/24 hours to 15000 g/m²/24 hours or 300 g/m²/24 hours to 5000 g/m²/24 hours or 350 g/m²/24 hours to 1000 g/m²/24 hours. The wound sealing film can have a leak rate of below 5, 10, 15, 20, 25, 30, 35, 40, 45, 50 cc/min over 30 mins, or any range thereof or rate therein. In some instances, the average rate is 5 to 50 cc/min over 30 min, 10 to 40 cc/min over 30 min, 10 to 30 cc/min over 30 mins, or below 30 cc/min over 30 mins. [0015] Certain embodiments are directed to a method of producing a wound sealing film. The wound sealing film can be any of the wound sealing films disclosed herein. The method can include (i) providing a first layer having a first surface and a second surface, said first layer can contain a first polymer composition, (ii) coupling a second layer having a first surface and a second surface with the first layer, said second layer can contain a polymeric gel; and (iii) coupling a third layer having a first surface and a second surface with the second layer, said third layer can contain an adhesive. The steps (i), (ii) and (iii) can be performed in any order or at the same time. In some aspects, the first surface of the second layer contacts the second surface of the first layer. In some aspects, the first surface of the third layer contacts the second surface of the second layer. In some aspects, the coupling of the second layer with the first layer can include casting a polymer gel precursor on the second surface of the first layer and curing the polymer gel precursor. In some aspects, the coupling of the second layer with the first layer can include laminating the second layer on the second surface of the first layer. In some aspects, a preformed second layer can be laminated on the second surface of the first layer. In some aspects, the coupling of the third layer with the second layer can include casting the adhesive on the second surface of the second layer to form the third layer.

[0016] In some aspects, the method can include forming a plurality of perforations through the second layer. In some aspects, the plurality of the perforations of the second layer can be formed by punching, cutting, drilling, dissolving, and/or melting one or more perforations through the second layer. The perforations can be formed in the second layer by casting or forming the second layer on a mold or by printing or casting the second layer to form perforations.

[0017] In some aspects, the method can include forming a plurality of perforations through the third layer. In some aspects, the plurality of the perforations of the third layer can be formed by punching, cutting, drilling, dissolving, and/or melting one or more perforations through the third layer. In some aspects, at least a portion of the plurality of perforations of the third layer can align with at least a portion of the plurality of perforations of the second layer. In some aspects all of the plurality of perforations of the third layer align with the plurality of perforations of the second layer. The perforations can be formed in the third layer by casting or forming the third layer on a mold or by printing or casting the third layer to form perforations.

[0018] In some aspects, the plurality of perforations of the second layer and the plurality of perforations of the third layer can be formed separately. In some aspects, the plurality of perforations of the second layer and the plurality of perforations of the third layer can be formed simultaneously. In some aspects, the plurality of perforations of the second layer and the plurality of perforations of the third layer can be formed before coupling the second layer and the third layer. In some aspects, the plurality of perforations of the second layer and the plurality of perforations of the third layer can be formed after coupling the second layer and the third layer. In some aspects, the plurality of perforations of the second layer can be formed before coupling the second layer and the third layer. In some aspects, the plurality of perforations of the second layer can be formed after coupling the second layer and the third layer. In some aspects, the second layer and the third layer can be coupled and the plurality of perforations of the second layer and the plurality of perforations of the third layer can be formed by punching, cutting, drilling, dissolving, and/or melting one or more perforations through the second layer and then continuing the punching, cutting, drilling, dissolving, and/or melting process to form one or more perforations through the third layer. In some aspects, the second layer and the third layer can be coupled and the plurality of perforations of the second layer and the plurality of perforations of the third layer can be formed by punching, cutting, drilling, dissolving, and/or melting one or more perforations through the third layer and then continuing the punching, cutting, drilling, dissolving, and/or melting process to form one or more perforations through the second layer. [0019] Certain embodiments are directed to a method of treating a wound. The method can include sealing a wound site with a wound sealing fdm of the current invention and applying a pressure differential to a wound in the wound site through an aperture in the wound sealing fdm. In some aspects a manifold can be positioned over at least a portion of the wound prior to sealing the wound site. In some aspects a negative pressure can be applied to the wound. In some aspects a positive pressure can be applied to the wound.

[0020] Certain embodiments are directed to a wound therapy system. The wound therapy system can include a wound sealing fdm of the current invention, a source of negative and/or positive pressure, and a fluid manifold. In some aspects, wound therapy system can further include, a portal capable of providing a fluid communication through the wound sealing fdm and between the source of negative and/or positive pressure and the fluid manifold.

[0021] Certain embodiments are directed to a kit comprising a wound sealing fdm of any one of the current invention and a fluid manifold. In some aspects, the kit can further include a portal capable of providing a fluid communication through the wound sealing fdm and between a source of negative and/or positive pressure and the fluid manifold.

[0022] As used herein, various terminology is used for the purpose of describing particular implementations only and is not intended to be limiting of implementations. For example, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not by itself indicate any priority or order of the element with respect to another element, but rather merely distinguishes the element from another element having a same name (but for use of the ordinal term). The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. Additionally, two items that are “coupled” may be unitary with each other. To illustrate, components may be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, communicational (e.g., wired or wireless), or chemical coupling (such as a chemical bond) in some contexts.

[0023] The average cross-sectional length of the plurality of perforations of the second layer refers to an average of lengths of the individual perforations along a surface (such as the first or the second surface) of the second layer.

[0024] The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. As used herein, the term “approximately” and “about” may be substituted with “within 10 percent of’ what is specified. Additionally, the term “substantially” and “about” may be substituted with “within [a percentage] of’ what is specified, where the percentage includes .1, 1, or 5 percent; or may be understood to mean with a design, manufacture, or measurement tolerance. The phrase “and/or” means and or. To illustrate, A, B, and/or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C. In other words, “and/or” operates as an inclusive or.

[0025] The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), and “include” (and any form of include, such as “includes” and “including”) are non-limiting and open ended and can include additional steps, material, etc. with its scope. As a result, an apparatus that “comprises,” “has,” or “includes” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, a method that “comprises,” “has,” or “includes” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.

[0026] Any aspect of any of the systems, methods, and article of manufacture can consist of or consist essentially of - rather than comprise/have/include - any of the described steps, elements, and/or features. Thus, in any of the claims, the term “consisting of’ or “consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb. Additionally, it will be understood that the term “wherein” may be used interchangeably with “where.”

[0027] Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.

[0028] Some details associated with the aspects of the present disclosure are described above, and others are described below. Other implementations, advantages, and features of the present disclosure will become apparent after review of the entire application, including the following sections: Brief Description of the Drawings, Detailed Description, and the Claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] A further understanding of the nature and advantages of the present disclosure may be realized by reference to the following drawings. The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers.

[0030] FIG. 1 is a sectional view (A) and a perspective view (B) of a wound sealing film according to an example of the current invention.

[0031] FIG. 2 is a sectional view (A) and a perspective view (B) of a wound sealing film according to an example of the current invention. [0032] FIG. 3 is a sectional view (A) and a perspective view (B) of a wound sealing fdm according to an example of the current invention.

[0033] FIG. 4 (A) is a top view of a second layer of a wound sealing fdm, according to an example of the current invention. (B) is a top view of a second layer of a wound sealing fdm, according to another example of the current invention.

[0034] FIG. 5 is the wound sealing fdm of FIG. 1 with a first cover layer and second cover layer. [0035] FIG. 6 (A) and (B) is a diagram of an example of a therapy system including a wound sealing fdm.

[0036] FIG. 7 illustrates time dependent leak rate for a wound sealing fdm according to an example of the current invention and comparison with two commercially available low leak drapes.

DETAILED DESCRIPTION

[0037] As used herein, the terms “tissue site” and “target tissue” as used herein can broadly refer to a wound (e.g., open or closed), a tissue disorder, and/or the like located on or within tissue, such as, for example, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, and/or the like. The terms “tissue site” and “target tissue” as used herein can also refer to a surrounding tissue area(s) and/or areas of tissue that are not necessarily wounded or exhibit a disorder, but include tissue that would benefit from tissue generation and/or tissue that may be harvested and transplanted to another tissue location. The terms “tissue site” and “target tissue” may also include incisions, such as a surgical incision. In some implementations, “target tissue” may correspond or refer to a wound, and “tissue site” may correspond or refer to a tissue area(s) surrounding and including the target tissue. Additionally, the term “wound” as used herein can refer to a chronic, subacute, acute, traumatic, and/or dehisced incision, laceration, puncture, avulsion, and/or the like, a partial-thickness and/or full thickness bum, an ulcer (e.g., diabetic, pressure, venous, and/or the like), flap, and/or graft. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, grafts, and fistulas, for example.

[0038] The term “positive-pressure” (or “hyperbaric”) as used herein generally refers to a pressure greater than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment (e.g., an internal volume). In most cases, this positive-pressure will be greater than the atmospheric pressure at which the patient is located. Alternatively, the positive-pressure may be greater than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in positive- pressure typically refer to an increase in absolute pressure, and decreases in positive-pressure typically refer to a decrease in absolute pressure. Additionally, the process of increasing pressure may be described illustratively herein as “applying”, “delivering,” “distributing,” “generating”, or “providing” positive-pressure, for example. [0039] The term “reduced-pressure” (and “negative-pressure” or “hypobaric”) as used herein generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment (e.g., an internal volume). In most cases, this reduced-pressure will be less than the atmospheric pressure at which the patient is located. Alternatively, the reduced-pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in reduced-pressure typically refer to a decrease in absolute pressure, and decreases in reduced-pressure typically refer to an increase in absolute pressure. Additionally, the process of reducing pressure may be described illustratively herein as “applying”, “delivering,” “distributing,” “generating”, or “providing” reduced-pressure, for example.

[0040] The term “fluid” may refer to liquid, gas, air, or a combination thereof. The term “fluid seal,” or “seal,” means a seal adequate to maintain a pressure differential (e.g., positive-pressure or reduced- pressure) at a desired site given the particular pressure source or subsystem involved. Similarly, it may be convenient to describe certain features in terms of fluid “inlet” or “outlet” in such a frame of reference. However, the fluid path may also be reversed in some applications, such as by substituting a reduced-pressure source (negative or hypobaric pressure source) for a positive-pressure source, and this descriptive convention should not be construed as a limiting convention.

[0041] FIG. 1A illustrates a sectional view of a wound sealing fdm according to an example of the current invention. The wound sealing fdm 100, can include a first layer 101, a second layer 102 and third layer 103. The first layer 101 can be any of the first layers or liquid barrier layers described herein. The second layer 102 can be any of the second layers or liquid retaining polymeric film layers described herein. The third layer 103 can be any of the third layers or adhesive layers described herein. The second layer 102 can be positioned between the first layer 101 and the third layer 103. FIG. IB illustrates a perspective view of the wound sealing film 100. The first layer 101 can have a first surface 104 and second surface 105. The second layer 102 can have a first surface 106 of the second surface 107. The third layer 103 can have a first surface 108 and second surface 109. The second surface 105 of first layer 101 can be in contact with the first surface 106 second layer 102. The second surface 107 of second layer 102 can be in contact with the first surface 108 third layer 103. In FIG. IB the layers are shown separated for representation purpose.

[0042] FIG. 2A illustrates a sectional view of a wound sealing film according to an example of the current invention. The wound sealing film 200, can include a first layer 201, a second layer 202 and third layer 203. The first layer 201 can be any of the first layers or liquid barrier layers described herein. The second layer 202 can be any of the second layers or liquid retaining polymeric film layers described herein. The third layer 203 can be any of the third layers or adhesive layers described herein. The second layer 202 can be positioned between the first layer 201 and the third layer 203. FIG. 2B illustrates a perspective view of the wound sealing film 200. The first layer 201 can have a first surface 204 and second surface 205. The second layer 202 can have a first surface 206 and second surface 207. The third layer 203 can have a first surface 208 and second surface 209. The second surface 205 of first layer 201 can be in contact with the first surface 206 of the second layer 202. The second surface 207 of second layer 202 can be in contact with the first surface 208 of the third layer 203. The second layer 202 can have a plurality of perforations 210. The third layer 203 can have plurality of perforations 211. The plurality of perforations 210 of the second layer 202 can be aligned with the plurality of perforations 211 of the third layer 202. In FIG. 2B the layers are shown separated for representation purpose. [0043] FIG. 3A illustrates a sectional view of wound sealing film according to an example of the current invention. The wound sealing film 300, can include a first layer 301, a second layer 302 and third layer 303. The first layer 301 can be any of the first layers or liquid barrier layers described herein. The second layer 302 can be any of the second layers or liquid retaining polymeric film layers described herein. The third layer 303 can be any of the third layers or adhesive layers described herein. The second layer 302 can positioned between the first layer 301 and the third layer 303. FIG. 3B illustrates a perspective view of the wound sealing film 300. The first layer 301 can have a first surface 304 and second surface 305. The second layer 302 can have a first surface 306 and second surface 307. The third layer 303 can have a first surface 308 and second surface 309. The second surface 305 of first layer 301 can be in contact with the first surface 306 of the second layer 302. The second surface 307 of second layer 302 can be in contact with the first surface 308 third layer 303. The second layer 302 can have a plurality of perforations 310. In FIG. 3B the layers are shown separated for representation purpose. [0044] The plurality of perforations 210, 310 of the second layer 202, 302 can contain perforations of any suitable shape and size. In some aspects, the plurality of perforations 210, 310 of the second layer 202, 302 can contain perforations of similar shape and/or size. In some aspects, the plurality of perforations 210, 310 of the second layer 202, 302 can contain perforations of different shape and/or size (not shown). Non limiting perforation shape includes, circular, oval, elliptical, square, rounded square, rectangular, rounded rectangular, pentagonal, rounded pentagonal, hexagonal, rounded hexagonal, heptagonal, rounded heptagonal, octagonal, rounded octagonal, star shaped, rounded star shaped, rod shaped or an irregular shaped. In some aspects, the plurality of perforations 210, 310 of the second layer 202, 302 can have an average cross-sectional length 212, 312 of 2 mm to 50 mm or at least any one of, equal to any one of, or between any two of 2 mm, 4 mm, 5 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 35 mm, 36 mm, 38 mm, 40 mm, 42 mm, 44 mm, 46 mm, 48 mm and 50 mm. In some aspects, the second layer forms ribs defining the perforations, and the ribs have an average cross-section length 250, 350 parallel to the first surface and second surface of the second layer of 1 to 6 mm or at least any one of, equal to any one of, or between any two of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm and 6 mm. In some aspects, the plurality of perforations 210, 310 of the second layer 202, 302 can form a repetitive pattern. In some aspects, the plurality of perforations 210, 310 of the second layer 202, 302 forms 25% to 98 %, or at least any one of, equal to any one of, or between any two of 25 %, 30 %, 35 %, 40 %, 45 %, 50 %, 55 %, 60 %, 65 %, 70 %, 75 %, 80 %, 85 %, 90 %, 95 %, and 98 % of the surface area of the second layer 202, 302. The adjacent perforations of the plurality of the perforations 210, 310 of the second layer 202, 302 can have centers separated by 10 mm to 100 mm or at least any one of, equal to any one of, or between any two of 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, and 100 mm. The plurality of perforations 210 of the second layer 202 can be aligned with the plurality of perforations 211 of the third layer 203. FIG. 4A and B illustrates a top view of a second layer according to two examples of the current invention. In one example FIG. 4A, the perforations of the second layer is circular in shape. In another example FIG. 4B, the perforations of the second layer forms a pattern of ribs of the second layer.

[0045] The first layer 101, 201, 301 can contain a first polymer. The first polymer can be polyurethane, polyethylene, cellulosics, polyamides, polyvinyl alcohol, polyvinyl pyrrolidone, acrylics, silicone elastomers, or copolymers of these. In some aspects, the first polymer can be polyurethane and the first layer 101, 201, 301 can be formed from a polyurethane film. In some particular aspects, the first layer 101, 201, 301 can be formed from a breathable cast matt polyurethane film sold by Expopack Advanced Coatings of Wrexham, United Kingdom under the name INSPIRE 2301 or INSPIRE 2327. In some aspects, width or thickness 113, 213, 313 of the first layer 101, 201, 301 can be 0.02 mm to 0.12 mm or at least any one of, equal to any one of, or between any two of 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.11 mm and 0.12 mm. In some aspects, the first layer 101, 201, 301 can have areal weight 30 gsm to 100 gsm or at least any one of, equal to any one of, or between any two of 30 gsm, 40 gsm, 50 gsm, 60 gsm, 70 gsm, 80 gsm, 90 gsm, and 100 gsm. [0046] In some aspects, the second layer 102, 202, 302 can contain a polymeric gel. In some aspects, the polymeric gel can contain a polyurethane gel, a hydrogel, a silicone gel, a hydrocolloid, or a combination thereof. In some aspects, the hydrocolloid can include, a polymer, a first particle containing a water absorbing compound; and optionally a plasticizer. In some aspects, the first particle can be dispersed in a matrix of the polymer. In some aspects, the water absorbing compound can be carboxymethyl cellulose and/or a salt thereof. In some aspect, the polymer can contain a water sensitive polymer. In some particular aspects, the water sensitive polymer can contain pectin, carrageenan, gelatin, and/or alginate. In some aspect, the polymer can contain a water non-sensitive polymer. In some particular aspects, the water non-sensitive polymer can contain an isoprene polymer, a styrene-ethylene- butene-styrene (SEBS) block polymer, an isoprene isobutene copolymer, a styrene-isoprene-styrene copolymer, an ethylene vinyl acetate copolymer or any combination thereof. In some aspects, the plasticizer can be a paraffinic plasticizer, a naphthenic plasticizer, a petroleum jelly, an amorphous alpha olefin, a natural oil or any combination thereof. In some aspects, the paraffinic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to 50 carbon atoms long. In some aspects, the paraffinic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to 50 carbon atoms long, the saturated hydrocarbon chains can contain areas that can crystalize (wax). In some aspects, the paraffinic plasticizer can be aromatic-free paraffinic white mineral oils. In some aspects, the paraffinic plasticizer can be paraffinic process oils. In some aspects, the paraffinic plasticizer can be paraffinic process oils manufactured via the solvent extraction process. In some aspects, the paraffinic plasticizer can be refined hydrotreated paraffinic process oils. In some aspects, the paraffinic plasticizer can be refined hydrotreated paraffinic process oils and are essentially colorless and sulfur free. In some aspects, the naphthenic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to 50 carbon atoms long and contain cyclic or ring structure. In some aspects, the amorphous alpha olefin can be atactic polypropylene. In some aspects the natural oil can be linseed oil, soybean oil, tall oil or any combination thereof.

[0047] In some aspects, the second layer 102, 202, 302 can have a water absorption rate of 0.5 g/g to 5 g/g or at least any one of, equal to any one of, or between any two of 0.5 g/g, 1 g/g, 1.5 g/g, 2 g/g, 2.5 g/g, 3 g/g, 3.5 g/g, 4 g/g, 4.5 g/g, and 5 g/g. In some aspects, the second layer 102, 202, 302 can have a dry adhesive strength of 5 N/25 cm to 15 N/25 cm or at least any one of, equal to any one of, or between any two of 5 N/25 cm, 7 N/25 cm, 9 N/25 cm, 11 N/25 cm, 13 N/25 cm, 15 N/25 cm, 17 N/25 cm, 19 N/25 cm, 21 N/25 cm, 23 N/25 cm, and 25 N/25 cm. In some aspects, moist adhesive strength of the second layer 102, 202, 302 can be 15 % to 75 %, or at least any one of, equal to any one of, or between any two of 15 %, 20 %, 25 %, 30 %, 35 %, 40 %, 45 %, 50 %, 55 %, 60 %, 65 %, 70 %, and 75 % of the dry adhesive strength of the second layer 102, 202, 302. In some aspects, the second layer 102, 202, 302 can have a density of 0.9 g/cc to 1.5 g/cc or at least any one of, equal to any one of, or between any two of 0.9 g/cc, 1 g/cc, 1.1 g/cc, 1.2 g/cc, 1.3 g/cc, 1.4 g/cc, and 1.5 g/cc. In some aspects, width or thickness 114, 214, 314 of the second layer 102, 202, 302 can be 0.1 mm to 1.2 mm or at least any one of, equal to any one of, or between any two of 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm and 1.2 mm. In some aspects, the second layer 102, 202, 302 can have a hardness of 10 to 50 Shore 00, or at least any one of, equal to any one of, or between any two of 10 shore 00, 20 shore 00, 30 shore 00, 40 shore 00, and 50 shore 00. In some aspects, the second layer 102, 202, 302 can be a transparent layer.

[0048] The third layer 103, 203, 303 can contain an adhesive. In some aspects, the adhesive can be a high tack acrylic adhesive and/or light switchable adhesive. In some aspects, the high tack acrylic adhesive can be high tack acrylic lumina adhesive. In some aspects, width or thickness 113, 213, 313 of the third layer 103, 203, 303 can be 0.01 mm to 0.1 mm or at least any one of, equal to any one of, or between any two of 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, and 0.1 mm. In some aspect, the light-switchable adhesive can be a light-switchable adhesive as described in US provisional application 62858089 by Locke et ak, which is incorporated herein by reference.

[0049] In some aspects, the light switchable adhesive can comprise: one or more polymers; first photo initiators configured to cause the one or more polymers to cross-link responsive to receiving first light; and second photo initiators configured to cause the one or more polymers to cross-link responsive to receiving second light, the second photo initiators different from the first photo initiators. In some aspects, the light switchable adhesive has at least three phases, each phase corresponding to a particular peel strength, and wherein the light switchable adhesive is configured to transition between a first two phases of the three phases based on activation of the first photo initiators and to transition between a second two phases of the three phases based on activation of the second photo initiators. In some aspects, the light switchable adhesive has a second peel strength in the second phase that is greater than a first peel strength of the light switchable adhesive in the first phase, and wherein a third peel strength of the light switchable adhesive in the third phase is less than the second peel strength. In some aspects, the one or more polymers include can an acrylate polymer, urethane acrylate polymer, methyl acrylate polymer, silicone acrylate polymer, polyether, polyurethane, or any combination thereof. In some aspects, the one or more polymers include can an acrylate polymer. In some aspects, the first photo initiators have apeak absorbance between 750 nanometers (nm) to 860 nm. In some aspects, the second photo initiators have a peak absorbance between 200 nanometers (nm) to 400 nm. In some particular aspects, the first photo initiators can include H-Nu-IR 780, H-Nu-IR 815, or both. In some particular aspects, the second photo initiators can include Irgacure 819. In some aspects, the light switchable adhesive can have a peel strength of less than 7 N/25 mm on stainless steel at an angle of 180 degrees in a first phase. In some aspects, the light switchable adhesive can have a peel strength of greater 8 N/25 mm on stainless steel at an angle of 180 degrees in a second phase. Additionally, or alternatively, the light switchable adhesive can have a peel strength of less than 7 N/25 mm on stainless steel at an angle of 180 degrees in a third phase. In some of the foregoing embodiments of the present compositions, the light switchable adhesive has a second level of cross-linking in the second phase that is greater than a first level of cross-linking in the first phase, and wherein the light switchable adhesive has a third level of cross-linking in the third phase that is greater than the second level of cross-linking. [0050] The wound sealing film 100, 200, 300 can further contain a first cover layer and/or a second cover layer. The first cover layer can contact the first surface 104, 204, 304 of the first layer 101, 201, 301. The second cover layer can contact the second surface 109, 209, 309 of the third layer 103, 203, 303. FIG. 5 illustrates wound sealing film 100 with the first cover layer 120 and second cover layer 121

[0051] In some aspects, moisture vapor transmission rate (MVTR) of the wound sealing film can be 100, 200, 300 can be 300 g/m²/24 hours to 15000 g/m²/24 hours or at least any one of, equal to any one of, or between any two of 300 g/m²/24 hours, 500 g/m²/24 hours, 1000 g/m²/24 hours, 2000 g/m²/24 hours, 3000 g/m²/24 hours, 4000 g/m²/24 hours, 5000 g/m²/24 hours, 6000 g/m²/24 hours, 7000 g/m²/24 hours, 8000 g/m²/24 hours, 9000 g/m²/24 hours, 10000 g/m²/24 hours, 11000 g/m²/24 hours, 12000 g/m²/24 hours, 13000 g/m²/24 hours, 14000 g/m²/24 hours, and 15000 g/m²/24 hours. The wound sealing film 100, 200, 300 can also function as a barrier to liquids and microorganisms. [0052] The wound sealing film 100, 200, 300 may be configured to couple to a bandage, a wound closure device, a dressing, and/or a drape, to provide a seal to create an enclosed space (e.g., an interior volume) corresponding to a tissue site. For example, wound sealing film 100, 200, 300 may be configured to provide a fluid seal (i.e., provide a portion of fluid seal) between two components and/or two environments, such as between a sealed therapeutic environment and a local ambient environment. To illustrate, when coupled to a tissue site, wound sealing film 100, 200, 300 is configured to maintain a pressure differential at the tissue site and/or keep fluids from permeating through the wound sealing film 100, 200, 300, as described further with reference to FIG. 6.

[0053] FIG. 6A shows a perspective view of an illustrative system 600 (e.g., a therapy system) for providing wound therapy. System 600 can include a wound sealing film 100 (shown), 200 (not shown), 300 (not shown), a therapy device 610, a canister 612, a tube 614, and a dressing 616. As an illustrative example, system 600 includes a wound sealing film 100, 200, 300 as part of dressing 616.

[0054] System 600 is configured to provide therapy (e.g., oxygen therapy, positive-pressure therapy, negative-pressure therapy, or a combination thereof) at a tissue site 620 associated with a target area of a patient. For example, dressing 616 may be in fluid communication with tissue site 620 and may be in fluid communication with therapy device 610 via tube 614. In some implementations, system 600 may include one or more components commercially available through and/or from KCI USA, Inc. of San Antonio, Tex., U.S.A., and/or its subsidiary and related companies (collectively, “KCI”).

[0055] Therapy device 610 (e.g., a treatment apparatus) is configured to provide therapy to tissue site 620 via tube 614 and dressing 616. For example, therapy device 610 may include a pressure source (e.g., a negative-pressure source, such as a pump, or a positive-pressure source, such as a pressurized oxygen container, an oxygen concentrator, or an oxygen collector) configured to be actuatable (and/or actuated) to apply pressure differential relative to ambient conditions to dressing 616. As illustrative, non-limiting examples, positive-pressure applied to a tissue site may typically range between 5 millimeters mercury (mm Hg) (667 pascals (Pa)) and 30 mm Hg (4.00 kilo (k) Pa). Common therapeutic ranges are between 10 mm Hg (1.33 kPa) and 25 mm Hg (3.33 kPa). As illustrative, non-limiting examples, reduced-pressure applied to a tissue site may typically ranges between -5 millimeters mercury (mm Hg) (-667 pascals (Pa)) and -500 mm Hg (-66.7 kilo (k) Pa). Common therapeutic ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).

[0056] In some implementations, therapy device 610 may alternate between providing positive- pressure therapy and negative-pressure therapy to the dressing 616, may provide positive-pressure therapy to a first portion of the dressing 616 and negative-pressure therapy to a second portion of the dressing 616, may provide no positive or negative pressure, or a combination thereof. In some such implementations, the therapy device 610 can provide positive-pressure therapy and negative-pressure therapy to the dressing 616 at the same time (e.g., partially concurrently). [0057] As illustrated in FIG. 6A, therapy device 610 includes canister 612 to receive fluid from tissue site 620 or to provide fluid to tissue site 620. Although canister 612 is illustrated as being internal to and/or integrated with therapy device 610, in other implementations, canister 612 can be external to therapy device 610 (not shown).

[0058] Therapy device 610 may also include one or more other components, such as a sensor, a processing unit (e.g., a processor), an alarm indicator, a memory, a database, software, a display device, a user interface, a regulator, and/or another component, that further facilitate positive-pressure therapy. Additionally, or alternatively, therapy device 610 may be configured to receive fluid, exudate, and or the like via dressing 616 and tube 614. Therapy device 610 may include one or connectors, such as a representative connector 638. Connector 638 is configured to be coupled to tube 614. Additionally, or alternatively, therapy device 610 may include one or more sensors, such a pressure sensor (e.g., a pressure transducer). The one or more sensors may be configured to enable therapy device 610 to monitor and/or sense a pressure associated with tube 614 and/or dressing 616.

[0059] Tube 614 includes one or more lumens (e.g., one or more through conduits), such as a single lumen conduit or multiple single-lumen conduits. Tube 614 (e.g., a least one of the one or more lumens) is configured to enable fluid communication between therapy device 610 and dressing 616. For example, fluid(s) and/or exudate can be communicated between therapy device 610 and dressing 616, and/or one or more pressure differentials (e.g., positive-pressure, negative pressure, or both) can be applied by therapy device 610 to dressing 616. As an illustrative, non-limiting illustration, tube 614 is configured to deliver at least pressurized oxygen from therapy device 610 to dressing 616 to establish positive-pressure. Communication of fluid(s) and application of a pressure differential can occur separately and/or concurrently.

[0060] In some implementations, tube 614 may include multiple lumens, such as a primary lumen (e.g., a positive-pressure/fluid lumen) for application of positive-pressure and/or communication of fluid, and one or more secondary lumens proximate to or around the primary lumen. The one or more secondary lumens (e.g., one or more ancillary/peripheral lumens) may be coupled to one or more sensors (of therapy device 610), coupled to one or more valves, as an illustrative, non-limiting example. Although tube 614 is described as a single tube, in other implementations, system 600 may include multiple tubes, such as multiple distinct tubes coupled to therapy device 610, dressing 616, or both.

[0061] As used herein, a “tube” broadly refers to a tube, pipe, hose, conduit, or other structure with one or more lumens adapted to convey fluid, exudate, and/or the like, between two ends. In some implementations, a tube may be an elongated, cylindrical structure with some flexibility; however, a tube is not limited to such a structure. Accordingly, tube may be understood to include a multiple geometries and rigidity. Tube 614 includes one or more lumens (e.g., one or more through conduits), such as a single lumen conduit or multiple single-lumen conduits. Tube 614 (e.g., a least one of the one or more lumens) is configured to enable fluid communication between therapy device 610 and dressing 616. For example, fluid(s) and/or exudate can be communicated between therapy device 610 and dressing 616, and/or one or more pressure differentials (e.g., positive-pressure, negative pressure, or both) can be applied by therapy device 610 to dressing 616. As an illustrative, non-limiting illustration, tube 614 is configured to deliver at least pressurized oxygen from therapy device 610 to dressing 616 to establish positive-pressure. Communication of fluid(s) and application of a pressure differential can occur separately and/or concurrently.

[0062] Dressing 616 includes a connector 630 (also referred to as a dressing connection pad or a pad), the wound sealing film 100 (or 200 or 300), and a manifold 634 (also referred to as a distribution manifold, fluid manifold or an insert). The wound sealing film 100 (or 200 or 300) may be coupled to connector 630. To illustrate, the wound sealing film 100 (or 200 or 300) may be coupled to connector 630 via an adhesive, a separate adhesive drape over at least a portion of connector 630 and at least a portion of the wound sealing film 100 (or 200 or 300), or a combination thereof, as illustrative, non limiting examples.

[0063] The wound sealing film 100 (or 200 or 300) may be configured to couple dressing 616 at tissue site 620 and/or to provide a seal to create an enclosed space (e.g., an interior volume) corresponding to tissue site 620. For example, wound sealing film 100 (or 200 or 300) may be configured to provide a fluid seal between two components and/or two environments, such as between a sealed therapeutic environment and a local ambient environment. To illustrate, when coupled to tissue site 620, wound sealing film 100 (or 200 or 300) is configured to maintain a pressure differential (provided by a positive-pressure source or a negative-pressure source) at tissue site 620. The wound sealing film 100 (or 200 or 300) may be configured to be coupled to tissue site 620 via the adhesive of the third layer 103, 203, 303.

[0064] Referring to FIG. 6B, when in use, the wound sealing film 100 (or 200 or 300) is configured to be positioned on and/or near tissue site 620, and may be secured at the tissue site 620. When in use, the third layer 103, 203, 303 of the wound sealing film 100 (or 200 or 300) is configured to contact tissue site 620.

[0065] Referring to FIG. 6A, manifold 634 is configured to be positioned on and/or near tissue site 620, and may be secured at the tissue site 620, such as secured by the wound sealing film 100 (or 200 or 300). The manifold 634 can be position over a wound. The term “manifold” as used herein generally refers to a substance or structure that may be provided to assist in applying a pressure differential (e.g., positive-pressure differential or negative-pressure differential) to, delivering fluids to, or removing fluids and/or exudate from a tissue site and/or target tissue. The manifold typically includes a plurality of flow channels or pathways that distribute fluids provided to and removed from the tissue site. In an illustrative implementation, the flow channels or pathways are interconnected to improve distribution of fluids provided to or removed from the tissue site. Manifold 634 may be a biocompatible material that may be capable of being placed in contact with the tissue site and distributing positive and/or negative-pressure to the tissue site. Manifold 634 may include, without limitation, devices that have structural elements arranged to form flow channels, such as foam, cellular foam, open-cell foam, porous tissue collections, liquids, gels, and/or a foam that includes, or cures to include, flow channels, as illustrative, non-limiting examples. Additionally, or alternatively, the manifold may include polyethylene, a polyolefin, a polyether, polyurethane, a co-polyester, a copolymer thereof, a combination thereof, or a blend thereof.

[0066] In some implementations, manifold 634 is porous and may be made from foam, gauze, felted mat, or other material suited to a particular biological application. In a particular implementation, manifold 634 may be a porous foam and may include a plurality of interconnected cells or pores that act as flow channels. The foam (e.g., foam material) may be either hydrophobic or hydrophilic. As an illustrative, non-limiting example, the porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, Tex. [0067] In some implementations, manifold 634 is also used to distribute fluids such as medications, antibacterials, growth factors, and other solutions to the tissue site. Other layers may be included in or on manifold 634, such as absorptive materials, wicking materials, hydrophobic materials, and hydrophilic materials. In an implementation in which the manifold 634 includes a hydrophilic material, manifold 634 may be configured to wick fluid away from tissue site 620 and to distribute positive- pressure to tissue site 620. The wicking properties of manifold 634 may draw fluid away from the tissue site 620 by capillary flow or other wicking mechanisms. An illustrative, non-limiting example of a hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex. Other hydrophilic foams may include those made from polyether and/or foams that have been treated or coated to provide hydrophilicity.

[0068] In some implementations, manifold 634 is constructed from bioresorbable materials that do not have to be removed from tissue site 620 following use of the system 600. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones. Manifold 634 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with manifold 634 to promote cell-growth. A scaffold may be a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials. Although a manifold 634 is illustrated in FIG. 6A, in other implementations, dressing 616 does not include manifold 634. In such implementations, wound sealing film 100 (or 200 or 300) of dressing 616 is coupled to connector 630.

[0069] Connector 630 can include a body 642 (e.g., a housing) and a base 644, and can be configured to be coupled to tube 614 via an interface 646 (e.g., a port). Base 644 can be configured to be coupled to dressing 616. For example, base 644 may be coupled, such as via an adhesive, and/or pressure to the wound sealing film 100 (or 200 or 300) and/or manifold 634. In some implementations, base 644 comprises a flange that is coupled to an end of body 642 and/or is integrally formed with body 642. Connector 630, such as body 642, base 644, interface 646, or a combination thereof, may be made of rigid material and/or a semi-rigid material. In a non-limiting example, connector 630 may be made from a plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, or polyether block amide copolymer. In some implementations, connector 630 is formed of a semi-rigid material that is configured to expand when under a force, such as positive-pressure greater than or equal to a particular amount of pressure. Additionally or alternatively, connector 630 may be formed of a semi-rigid material that is configured to collapse when under a force, such as reduced-pressure less than or equal to a threshold pressure. [0070] Body 642 includes one or more channels or one or more conduits that extend from and/or are coupled to interface 646. To illustrate, body 642 may include a primary channel configured to be coupled in fluid communication with a primary lumen of tube 614. The primary channel may be coupled to a cavity (e.g., atissue cavity partially defined by body 642) having an aperture open towards manifold 634 (and/or towards tissue site 620). For example, the primary channel may include a first opening associated with interface 646 and a second opening (distinct from the aperture of the cavity) associated with the cavity. Thus, the primary channel may define a through channel of body 642 to enable fluid communication between interface 646 and tissue site 620.

[0071] Body 642 includes a channel (e.g., a through channel) having a first aperture open opposite dressing 616 and a second aperture open towards dressing 616. For example, the first aperture is located on an outer surface side (e.g., an ambient environment surface) of connector 630 and the second aperture is located on an inner surface side (e.g., atissue facing side) of connector 630. Illustrative, non-limiting examples of commercially available connectors include a “V.A.C. T.R.A.C.® Pad,” or “Sensa T.R.A.C.® Pad” available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex.

[0072] In some implementations dressing 616 further includes a bandage and/or a wound closure device (not shown). For example, a bandage may be placed over a wound to protect the wound and a wound closure device may be placed proximate to a wound to provide a force to maintain tissue in fixed position to promote wound closure.

[0073] During operation of system 600, dressing 616 is coupled to tissue site 620 over a wound. Additionally, dressing 616 is coupled to device 610 via tube 614. In some implementations, prior to coupling the dressing 616 to the tissue site 620, a manifold 634 is coupled to tissue site 620 proximate to or over the wound. The dressing 616 with the wound sealing film 100 (or 200 or 300) is then coupled over the manifold 634 to seal the wound. In some aspects, an aperture 670 can be made in the wound sealing film 100 (or 200 or 300) over the manifold, where the aperture 670 that extends through wound sealing film 100 (or 200 or 300) enables a fluid communication between therapy device 610 and the wound in the tissue site through the manifold 634. In some aspects, the wound sealing fdm 100 (or 200 or 300) can have a preformed aperture 670, wherein the aperture is placed over a manifold 634 over a wound. In some aspects, a wound contact layer (not shown) is placed between the wound surface a the manifold.

[0074] A pressure differential, such as positive-pressure, can be generated and/or applied to dressing 616 (e.g., the interior volume of dressing 616) by a pressure source associated with device 610. When positive-pressure is generated and/or applied to dressing 616, fluid or medication from device 610, such as from canister 612, may be transported to the wound in the tissue site 620 through the dressing 616. Furthermore, in some implementations, reduced-pressure can be applied to the wound in the tissue site 620 through the dressing 616 by a reduced-pressure source associated with device 610. When reduced- pressure is applied, fluid, exudate, or other material from the wound in the tissue site 620 may be transported to canister 612 of device 610.

[0075] The above specification and examples provide a complete description of the structure and use of illustrative examples. Although certain aspects have been described above with a certain degree of particularity, or with reference to one or more individual examples, those skilled in the art could make numerous alterations to aspects of the present disclosure without departing from the scope of the present disclosure. As such, the various illustrative examples of the methods and systems are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and implementations other than the ones shown may include some or all of the features of the depicted examples. For example, elements may be omitted or combined as a unitary structure, connections may be substituted, or both. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and/or functions, and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one example or may relate to several examples. Accordingly, no single implementation described herein should be construed as limiting and implementations of the disclosure may be suitably combined without departing from the teachings of the disclosure.

[0076] The previous description of the disclosed implementations is provided to enable a person skilled in the art to make or use the disclosed implementations. Various modifications to these implementations will be readily apparent to those skilled in the art, and the principles defined herein may be applied to other implementations without departing from the scope of the disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope possible consistent with the principles and novel features as defined by the following claims. The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively. EXAMPLES

[0077] As part of the disclosure of the present invention, specific examples are included below. The examples are for illustrative purposes only and are not intended to limit the invention. Those of ordinary skill in the art will readily recognize parameters that can be changed or modified to yield essentially the same results.

Example 1

Leak testing with a wound sealing film according to an example of the current invention [0078] Method: A wound sealing film according to an example of the current invention was applied to a synthetic wound model and a vacuum applied to the model through the film which was connected to a TAC pad which in turn was attached to a vacuum generating device. The flow through the dressing was measured by connecting the vacuum tubing of the dressing to a flow meter, a Furness device. The airflow required to maintain the predetermined therapy pressure was measured and corresponds to the leak rate for the dressing. The wound sealing film used for the test contains a first layer containing a polyurethane, a second layer containing polyurethane gel and third layer containing high tack acrylic lumina adhesive. The results (FIG. 7) show a comparison with two commercially available low leak drapes. Commercial low leak drape 1 contains acrylic adhesive layer, and a commercial low leak drape 2 contains a silicone and acrylic hybrid layer.

[0079] Results: FIG. 7 shows the wound sealing film disclosed herein has a leak rate lower than the two commercially available low leak drapes. The wound sealing film disclosed herein showed a leak rate below 30 cc/min over 30 mins.

Example 2

MVTR testing with a wound sealing film according to an example of the current invention [0080] Method: MVTR testing was performed using the inverted cup technique as measured by ASTM E96. Cup surface area was 0.003167 m² . Unoccluded sample diameter was 63.5 mm. The wound sealing film used for the test contains a first layer containing a polyurethane, a second layer containing polyurethane gel and third layer containing high tack acrylic lumina adhesive.

[0081] Results: Table 1 shows weight change over time for duplicate tests of the wound sealing film disclosed herein.

TABLE 1: WEIGHT CHANGE OVER TIME

[0082] MVTR of the wound sealing film, calculated from the data presented in Table 1 was 385 g/m²/24 hours. This MVTR was higher than two other commercially available low leak wound sealing films tested (drape 1 and drape 2 of Example 1 at 321 and 336 g/m²/24 hours, respectively).

Claims

1. A wound sealing film comprising: a first layer having a first surface and a second surface, said first layer comprising a first polymer composition; a second layer having a first surface and a second surface, said second layer comprising a polymeric gel; and a third layer having a first surface and a second surface, said third layer comprising an adhesive, wherein the second layer is positioned between the first layer and the third layer.

2. The wound sealing film of claim 1, wherein the second surface of the first layer is in contact with the first surface of the second layer and/or the second surface of the second layer is in contact with the first surface of the third layer.

3. The wound sealing film of any one of claims 1 to 2, wherein the second layer comprises a plurality of perforations.

4. The wound sealing film of claim 3, wherein the plurality of perforations of the second layer have an average cross-sectional length about 2 mm to about 50 mm.

5. The wound sealing film of any one of claims 3 to 4, wherein the plurality of perforations of the second layer have an average cross-sectional length between about 5 mm and about 35 mm.

6. The wound sealing film of any one of claims 3 to 5, wherein the plurality of perforations of the second layer comprises adjacent perforations having centers separated by 5 mm to 100 mm.

7. The wound sealing film of any one of claims 3 to 6, wherein the plurality of perforations of the second layer comprises adjacent perforations having centers separated by 10 mm to 70 mm.

8. The wound sealing film of any one of claims 3 to 7, wherein the second layer forms ribs defining the perforations, and the ribs have an average cross-section length parallel to the first surface and second surface of the second layer of between 1 to 6 mm.

9. The wound sealing film of any one of claims 3 to 8, wherein the plurality of perforations of the second layer forms a repetitive pattern.

10. The wound sealing film of any one of claims 3 to 9, wherein the plurality of perforations of the second layer forms 25% to 98% of the surface area of the second layer.

11. The wound sealing film of any one of claims 1 to 10, wherein the third layer comprises a plurality of perforations.

12. The wound sealing film of claim 11, wherein at least a portion of the plurality of perforations of the third layer are aligned with at least a portion of the perforations of the second layer.

13. The wound sealing film of any one of claims 1 to 12, wherein the first polymer is polyurethane, polyethylene, cellulosics, polyamides, polyvinyl alcohol, polyvinyl pyrrolidone, acrylics, silicone elastomers, or a copolymer thereof.

14. The wound sealing film of any one of claims 1 to 13, wherein the first layer is 0.02 mm to 0.12 mm thick.

15. The wound sealing film of any one of claims 1 to 14, wherein the first layer has an areal weight of 30 to 100 grams per square meter (gsm).

16. The wound sealing film of any one of claims 1 to 15, wherein the polymeric gel comprises a polyurethane gel, a hydrogel, a silicone gel, a hydrocolloid or any combination thereof.

17. The wound sealing film of claim 16, wherein the hydrocolloid comprises: a polymer; a first particle comprising a water absorbing compound; and optionally a plasticizer.

18. The wound sealing film of claim 17, wherein the first particle is dispersed in a matrix of the polymer.

19. The wound sealing film of any of one claims 17 or 18, wherein the water absorbing compound is carboxymethyl cellulose and/or a salt thereof.

20. The wound sealing film of any of one claims 17 to 19, wherein the polymer comprises a water sensitive polymer.

21. The wound sealing film of claim 20, wherein the water sensitive polymer comprises pectin, carrageenan, gelatin, and/or alginate.

22. The wound sealing film of any of one claims 17 to 21, wherein the polymer comprises a water non-sensitive polymer.

23. The wound sealing film of claim 22, wherein the water non-sensitive polymer comprises an isoprene polymer, a styrene-ethylene-butene-styrene (SEBS) block polymer, an isoprene isobutene copolymer, a styrene-isoprene-styrene copolymer, or an ethylene vinyl acetate copolymer.

24. The wound sealing film of any of one claims 17 to 23, wherein the plasticizer is a paraffinic plasticizer, a naphthenic plasticizer, a petroleum jelly, an amorphous alpha olefin, a natural oil, or any combination thereof.

25. The wound sealing film of any of one claims 1 to 24, wherein the second layer has a water absorption rate of 0.5 g/g to 5 g/g, dry adhesive strength of 5N/25 cm to 15N/25 cm, density of 0.9 g/cc to 1.5 g/cc or any combination thereof.

26. The wound sealing film of any one of claims 1 to 25, wherein the second layer is 0.1 mm to 1.2 mm thick.

27. The wound sealing film of any one of claims 1 to 26, wherein the second layer has a hardness of 10 to 50 Shore 00.

28. The wound sealing film of any one of claims 1 to 27, wherein the second layer is a transparent layer.

29. The wound sealing film of any one of claims 1 to 28, wherein the adhesive is a high tack acrylic adhesive and/or light-switchable adhesive.

30. The wound sealing film of any one of claims 1 to 29, wherein the third layer is 0.01 mm to 1 mm thick.

31. The wound sealing film of any one of claims 1 to 30, comprising a first cover layer removably attached to the first layer.

32. The wound sealing film of claim 31, wherein the first cover layer is a light blocking layer.

33. The wound sealing film of any one of claims 1 to 32, comprising a second cover surface removably attached to the third layer.

34. The wound sealing film of any of claims 1 to 33, wherein the wound sealing film is included in a drape, a bandage, a wound closure device, a therapy system adhesive, a negative-pressure therapy system, or a combination thereof.

35. The wound sealing film of any of claims 1 to 34, wherein the second surface of the third layer is configured to contact a skin of a subject during use of the wound sealing film to seal a wound of the subject.

36. The wound sealing film of any of claims 1 to 35, wherein the wound sealing film has a moisture vapor transmission rate (MVTR) 300 g/m²/24 hours to 15000 g/m²/24 hours.

37. A method of producing a wound sealing film, the method comprising: providing a first layer having a first surface and a second surface, said first layer comprising a first polymer composition; coupling a second layer with the first layer, said second layer comprising a polymeric gel; and coupling a third layer with the second layer, said third layer comprising an adhesive.

38. The method of claim 37, wherein the first surface of the second layer contacts the second surface of the first layer.

39. The method of any one of claims 37 or 38, wherein the first surface of the third layer contacts the second surface of the second layer.

40. The method of any one of claims 37 to 39, wherein the coupling of the second layer with the first layer comprises casting a polymer gel precursor on the second surface of the first layer and curing the polymer gel precursor.

41. The method of any one of claims 37 to 40, wherein the coupling of the second layer with the first layer comprises laminating a preformed second layer on the second surface of the first layer.

42. The method of any one of claims 37 to 41, wherein the coupling of the third layer with the second layer comprises casting the adhesive on the second surface of the second layer to form the third layer.

43. The method of any one of claims 37 to 42, comprising forming a plurality of perforations through the second layer.

44. The method of claim 43 , wherein the plurality of the perforations of the second layer are formed by punching, cutting, drilling, and/or melting one or more perforations through the second layer.

45. The method of any one of claims 43 or 44, wherein the plurality of perforations of the second layer have an average cross-sectional length between about 2 mm and about 50 mm.

46. The method of any one of claims 43 to 45, wherein the plurality perforations of the second layer have an average cross-sectional length between about 5 mm and about 35 mm.

47. The method of any one of claims 43 to 46, wherein the plurality of perforations of the second layer comprises adjacent perforations having centers separated by 5 mm to 100 mm.

48. The method of any one of claims 43 to 47, wherein the plurality of perforations of the second layer comprises adjacent perforations having centers separated by 10 mm to 70 mm.

49. The method of any one of claims 43 to 48, wherein the plurality of perforations of the second layer forms a repetitive pattern.

50. The method of any one of claims 43 to 49, wherein the second layer forms ribs defining the perforations, and the ribs have an average cross-section length parallel to the first surface and second surface of the second layer of between 1 to 6 mm.

51. The method of any one of claims 37 to 50, comprising forming a plurality of perforations through the third layer.

52. The method of claim 51, wherein at least a portion of the plurality of perforations of the third layer align with at least a portion of the plurality of perforations of the second layer.

53. The method of any one of claims 51 or 52, wherein the plurality of the perforations of the third layer are formed by punching, cutting, drilling, and/or melting one or more perforations through the third layer.

54. The method of any one of claims 37 to 53, wherein the wound sealing film is any one of the wound sealing films of claims 1 to 37.

55. A method of treating a wound, the method comprising : sealing a wound site with the wound sealing film of any one of claims 1 to 37, and applying a pressure differential to a wound in the wound site through an aperture through the wound sealing film.

56. The method of claim of 55, wherein a manifold is positioned over at least a portion of the wound prior to sealing the wound site.

57. The method of claim of any one of claim 55 or 56, wherein a negative pressure is applied to the wound.

58. A drape comprising: a liquid barrier layer comprising a polymeric film; a liquid retaining polymeric film layer in contact with the liquid barrier layer; and an adhesive layer in contact with the water retaining polymeric film layer.

59. The drape of claim 58, wherein the liquid retaining polymeric film layer comprises a hydrocolloid, a silicone, and/or a polyurethane.

60. The drape of any one of claims 58 or 59, wherein the liquid retaining polymeric film layer forms a plurality of apertures and is contact with at least 5 to 98 % of a major surface of the liquid barrier layer.

61. The drape of claim 60, wherein the liquid retaining polymeric film layer forms a web pattern or reticulated pattern.

62. The drape of any one of claims 58 to 61, wherein the adhesive layer comprises an acrylic adhesive and/or a light switchable adhesive.

63. A wound therapy system comprising: a drape or wound sealing film of any one of claims 1 to 36 or 58 to 62, a source of negative and/or positive pressure, and a fluid manifold.

64. The wound therapy system of claim 63, further comprising a portal capable of providing a fluid communication through the drape or wound sealing film and between the source of negative and/or positive pressure and the fluid manifold.

65. A kit comprising a drape or wound sealing film of any one of claims 1 to 36 or 58 to 62 and a fluid manifold.

66 The kit of claim 65, wherein the kit further comprises a portal capable of providing a fluid communication through the drape or wound sealing film and between a source of negative and/or positive pressure and the fluid manifold.