Patent Description:
Efficient sealing between the wound covering and a patient skin is desirable for negative pressure therapy. <CIT> discloses a negative pressure treatment system including a hybrid drape having a film layer, a layer of bonding adhesive, and a mesh. <CIT> discloses a negative pressure dressing having a drape, a manifold, and a wound contact layer with fenestrations.

The invention is defined by the independent claim. A selection of optional features of the invention is set out in the dependent claims.

Insofar as the term invention or embodiment is used in the following, or features are presented as being optional, this should be interpreted in such a way that the only protection sought is that of the invention claimed (with due regard to Article <NUM> EPC and the protocol thereto). References to "embodiment(s)" throughout the description which are not under the scope of the appended claims merely represent possible exemplary executions and are not part of the present invention.

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 nonidentical reference numbers.

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 burn, 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 burns, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, grafts, and fistulas, for example.

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.

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.

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.

The wound sealing film disclosed herein can provide many benefits, including lower leak rates, higher moisture vapor transmission rates, highly conformability, flow-able sealing that can seal creases and leaks, high bond strength, color changing to indicate when the wound sealing film has been exposed to electromagnetic energy that increases or decreases the tackiness of the wound sealing film, high moisture vapor transfer rate over the entire surface of the film, and a lower cost.

<FIG> illustrates a sectional view of a wound sealing film according to an example of the current invention. The wound sealing film <NUM>, can include a first layer <NUM>, a second layer <NUM> and third layer <NUM>. The first layer <NUM> can be any of the first layers or liquid barrier layers described herein. The second layer <NUM> can be any of the second layers or adhesive layers described herein. The third layer <NUM> can be any of the third layers or liquid retaining polymeric film layers described herein. The second layer <NUM> can be positioned between the first layer <NUM> and the third layer <NUM>. <FIG> illustrates a perspective view of the wound sealing film <NUM>. The first layer <NUM> can have a first surface <NUM> and second surface <NUM>. The second layer <NUM> can have a first surface <NUM> of the second surface <NUM>. The third layer <NUM> can have a first surface <NUM> and second surface <NUM>. The second surface <NUM> of first layer <NUM> can be in contact with the first surface <NUM> of the second layer <NUM>. The second surface <NUM> of second layer <NUM> can be in contact with the first surface <NUM> third layer <NUM>. In <FIG> the layers are shown separated for representation purpose.

<FIG> illustrates a sectional view of a wound sealing film according to an example of the current invention. The wound sealing film <NUM>, can include a first layer <NUM>, a second layer <NUM> and third layer <NUM>. The first layer <NUM> can be any of the first layers or liquid barrier layers described herein. The second layer <NUM> can be any of the second layers or adhesive layers described herein. The third layer <NUM> can be any of the third layers or liquid retaining polymeric film layers described herein. The second layer <NUM> can be positioned between the first layer <NUM> and the third layer <NUM>. <FIG> illustrates a perspective view of the wound sealing film <NUM>. The first layer <NUM> can have a first surface <NUM> and second surface <NUM>. The second layer <NUM> can have a first surface <NUM> and second surface <NUM>. The third layer <NUM> can have a first surface <NUM> and second surface <NUM>. The second surface <NUM> of first layer <NUM> can be in contact with the first surface <NUM> of the second layer <NUM>. The second surface <NUM> of second layer <NUM> can be in contact with the first surface <NUM> of the third layer <NUM>. The third layer <NUM> can have a plurality of perforations <NUM>. Perforations <NUM> of the third layer <NUM> can be of difference shape. <FIG> illustrate a top view of the third layer according to two examples of the current invention, the residual third layer is shown in black and the perforations of the third layer is shown in white.

<FIG> illustrates a sectional view of wound sealing film according to an example of the current invention. The wound sealing film <NUM>, can include a first layer <NUM>, and a combined layer <NUM>. The first layer <NUM> can be any of the first layers or liquid barrier layers described herein. The combined layer <NUM> can be any of the combined layers or polymeric gel adhesive layers described herein. <FIG> illustrates a perspective view of the wound sealing film <NUM>. The first layer <NUM> can have a first surface <NUM> and second surface <NUM>. The combined layer <NUM> can have a first surface <NUM> and second surface <NUM>. The second surface <NUM> of first layer <NUM> can be in contact with the first surface <NUM> of the combined layer <NUM>. In <FIG> the layers are shown separated for representation purpose.

<FIG> illustrates a sectional view of a wound sealing film according to an example of the current invention. The wound sealing film <NUM>, can include a first layer <NUM>, and a combined layer <NUM>. The first layer <NUM> can be any of the first layers or liquid barrier layers described herein. The combined layer <NUM> can be any of the combined layers described herein. <FIG> illustrates a perspective view of the wound sealing film <NUM>. The first layer <NUM> can have a first surface <NUM> and second surface <NUM>. The combined layer <NUM> can have a first surface <NUM> and second surface <NUM>. The second surface <NUM> of first layer <NUM> can be in contact with the first surface <NUM> of the combined layer <NUM>. The combined layer <NUM> can have a plurality of perforations <NUM>. Perforations <NUM> of the combined layer <NUM> can be of difference shape and size. <FIG> and <FIG> illustrates a top view of the combined layer according to two examples of the current invention, the residual combined layer is shown in black and the perforations of the combined layer is shown in white.

The plurality of perforations <NUM> of the third layer <NUM> can contain perforations of any suitable shape and size. In some aspects, the plurality of perforations <NUM> of the third layer <NUM> can contain perforations of similar shape and/or size. In some aspects, the plurality of perforations <NUM> of the third layer <NUM> can contain perforations of different shape and/or size. 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 <NUM> of the third layer <NUM> can have an average cross-sectional length <NUM> of <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>. In some aspects, the third layer <NUM> forms ribs <NUM> 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 <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>. In some aspects, the plurality of perforations <NUM> of the third layer <NUM> can form a repetitive pattern. In some aspects, the plurality of perforations <NUM> of the third layer <NUM> forms <NUM>% to <NUM> %, or at least any one of, equal to any one of, or between any two of <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, and <NUM> % of the surface area of the third layer <NUM>. The adjacent perforations of the plurality of the perforations <NUM> of the third layer <NUM> can have centers separated by <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

The plurality of perforations <NUM> of the combined layer <NUM> can contain perforations of any suitable shape and size. In some aspects, the plurality of perforations <NUM> of the combined layer <NUM> can contain perforations of similar shape and/or size. In some aspects, the plurality of perforations <NUM> of the combined layer <NUM> can contain perforations of different shape and/or size. 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 <NUM> of the combined layer <NUM> can have an average cross-sectional length <NUM> of <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>. In some aspects, the combined layer <NUM> forms ribs <NUM> 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 <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>. In some aspects, the plurality of perforations <NUM> of the combined layer <NUM> can form a repetitive pattern. In some aspects, the plurality of perforations <NUM> of the combined layer <NUM> forms <NUM>% to <NUM> %, or at least any one of, equal to any one of, or between any two of <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, and <NUM> % of the surface area of the combined layer <NUM>. The adjacent perforations of the plurality of the perforations <NUM> of the combined layer <NUM> can have centers separated by <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

The first layer <NUM>, <NUM>, <NUM>, <NUM> can contain a first polymer, such as the polymers of any of the first layers discussed herein and above. 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 <NUM>, <NUM>, <NUM>, <NUM> can be formed from a polyurethane film. In some particular aspects, the first layer <NUM>, <NUM>, <NUM>, <NUM> can be formed from a breathable cast matt polyurethane film sold by Expopack Advanced Coatings of Wrexham, United Kingdom under the name INSPIRE <NUM> or INSPIRE <NUM>. In some aspects, width or thickness <NUM>, <NUM>, <NUM>, <NUM> of the first layer <NUM>, <NUM>, <NUM>, <NUM> can be <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>. In some aspects, the first layer <NUM>, <NUM>, <NUM>, <NUM> can have a real weight <NUM> gsm to <NUM> gsm or at least any one of, equal to any one of, or between any two of <NUM> gsm, <NUM> gsm, <NUM> gsm, <NUM> gsm, <NUM> gsm, <NUM> gsm, <NUM> gsm, and <NUM> gsm.

The second layer <NUM>, <NUM> can contain an adhesive. The adhesive can be any of the adhesives of the second layer disclosed herein and above. In some aspects, the adhesive can be a high tack acrylic adhesive and/or light switchable adhesive. In some aspects, width or thickness <NUM>, <NUM> of the second layer <NUM>, <NUM> can be <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some aspect, the light-switchable adhesive can be a light-switchable adhesive as described in <CIT>.

In some aspects, the third layer <NUM>, <NUM> can contain a polymeric gel. The polymer gel can be any of the polymeric gels of the third layer described herein and above. 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 <NUM> carbon atoms long. In some aspects, the paraffinic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to <NUM> 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 <NUM> 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. In some aspects, the third layer <NUM>, <NUM> can have a water absorption rate of <NUM>/g to <NUM>/g or at least any one of, equal to any one of, or between any two of <NUM>/g, <NUM>/g, <NUM>/g, <NUM>/g, <NUM>/g, <NUM>/g, <NUM>/g, <NUM>/g, <NUM>/g, and <NUM>/g. In some aspects, the third layer <NUM>, <NUM> can have a dry adhesive strength of <NUM> N/<NUM> to <NUM> N/<NUM> or at least any one of, equal to any one of, or between any two of <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, <NUM> N/<NUM>, and <NUM> N/<NUM>. In some aspects, moist adhesive strength of the third layer <NUM>, <NUM> can be <NUM> % to <NUM> %, or at least any one of, equal to any one of, or between any two of <NUM> %, <NUM> %, <NUM>%, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, or <NUM> % of the dry adhesive strength of the second layer <NUM>, <NUM>, <NUM>. In some aspects, the third layer <NUM>, <NUM> can have a density of <NUM>/cc to <NUM>/cc or at least any one of, equal to any one of, or between any two of <NUM>/cc, <NUM>/cc, <NUM>/cc, <NUM>/cc, <NUM>/cc, <NUM>/cc, and <NUM>/cc. In some aspects, width or thickness <NUM>, <NUM> of the third layer <NUM>, <NUM> can be <NUM> to <NUM> or at least any one of, equal to any one of, or between any two of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM>. In some aspects, the third layer <NUM>, <NUM> can have a hardness of <NUM> to <NUM> Shore <NUM>, or at least any one of, equal to any one of, or between any two of <NUM> shore <NUM>, <NUM> shore <NUM>, <NUM> shore <NUM>, <NUM> shore <NUM>, and <NUM> shore <NUM>, as measured by ASTM D2240 using a shore durometer. In some aspects, the third layer <NUM>, <NUM> can be a transparent layer.

The combined layer <NUM>, <NUM> can contain an adhesive and a polymeric gel. The adhesive and the polymeric gel can be any of the adhesives or polymeric gels disclosed in a combination layer herein or above. In some aspects, combined layer <NUM>, <NUM> can be a homogenous mixture of the adhesive and the polymeric gel. In some aspects, the adhesive can be a high tack acrylic adhesive and/or light switchable adhesive. In some aspect, the light-switchable adhesive can be a light-switchable adhesive as described in <CIT>. 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 <NUM> carbon atoms long. In some aspects, the paraffinic plasticizer can contain branched or non-branched saturated hydrocarbon chains, up to <NUM> 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 <NUM> 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.

In some aspects, the combined layer <NUM>, <NUM> can have a water absorption rate of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>/g or any range thereof or rate therein, such as <NUM>/g to <NUM>/g. In some aspects, the combined layer <NUM>, <NUM> can have a bond strength to steel of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> N/<NUM> or any range thereof or strength therein, such as <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, or <NUM> to <NUM> N/<NUM>. In some aspects, the combined layer <NUM>, <NUM> can have a dry adhesive strength of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> N/<NUM> or any range thereof or strength therein, such as <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, <NUM> to <NUM>, or <NUM> to <NUM> N/<NUM>. In some aspects, moist adhesive strength of the combined layer <NUM>, <NUM> can be <NUM> % to <NUM> %, or at least any one of, equal to any one of, or between any two of <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, <NUM> %, or <NUM> % of the dry adhesive strength of the combined layer <NUM>, <NUM>. In some aspects, the combined layer <NUM>, <NUM> can have a density of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>/cc or any range thereof or rate therein, such as <NUM>/cc to <NUM>/cc. In some aspects, width or thickness <NUM>, <NUM> of the combined layer <NUM>, <NUM> can be <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>, or any range thereof or thickness therein thick, such as <NUM> to <NUM> thick. In some aspects, the combined layer <NUM>, <NUM> can have a hardness of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> Shore <NUM> or any range thereof or hardness therein such as <NUM> to <NUM> Shore <NUM> as measured by ASTM D2240 using a shore durometer. In some aspects, the combined layer <NUM>, <NUM> can have an areal weight of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> grams per square meter (gsm) or any range thereof or areal weight therein such as <NUM> to <NUM> gsm. In some aspects, the combined layer <NUM>, <NUM> can have a moisture vapor transfer rate (MVTR) of greater than <NUM>/m<NUM>/<NUM> hours. In some aspects, the combined layer can have a moisture vapor transfer rate (MVTR) of greater than <NUM>/m<NUM>/<NUM> hours, greater than <NUM>/m<NUM>/<NUM> hours, greater than <NUM>/m<NUM>/<NUM> hours, greater than <NUM>/m<NUM>/<NUM> hours, greater than <NUM>/m<NUM>/<NUM> hours, or at least <NUM>/m<NUM>/<NUM> hours. The moisture vapor transfer rate of the combined layer can be <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>/m<NUM>/<NUM> hours or any range thereof or weight therein. In some aspects, the combined layer <NUM>, <NUM> can be a transparent layer.

In some aspects, the light switchable adhesive, including an adhesive polymeric gel, 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 can be 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 can be 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 can be an acrylate polymer or polyurethane polymer. In some aspects, the first photo initiators have a peak absorbance between <NUM> nanometers (nm) to <NUM>. In some aspects, the second photo initiators have a peak absorbance between <NUM> nanometers (nm) to <NUM>. In some particular aspects, the first photo initiators can include H-Nu-IR <NUM>, H-Nu-IR <NUM>, or both. In some particular aspects, the second photo initiators can include Irgacure <NUM>. In some aspects, the light switchable adhesive can have a peel strength of less than <NUM> N/<NUM> on stainless steel at an angle of <NUM> degrees in a first phase. In some aspects, the light switchable adhesive can have a peel strength of greater <NUM> N/<NUM> on stainless steel at an angle of <NUM> degrees in a second phase. Additionally, or alternatively, the light switchable adhesive can have a peel strength of less than <NUM> N/<NUM> on stainless steel at an angle of <NUM> 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.

The wound sealing film <NUM>, <NUM>, <NUM>, <NUM> can further contain a first cover layer and/or a second cover layer. The first cover layer can contact the first surface <NUM>, <NUM>, <NUM>, <NUM> of the first layer <NUM>, <NUM>, <NUM>, <NUM>. The second cover layer can contact the second surface <NUM>, <NUM> of the third layer <NUM>, <NUM> or the second surface <NUM>, <NUM> of the combined layer <NUM>, <NUM>. <FIG> illustrates wound sealing film <NUM> (A) with the first cover layer <NUM> and second cover layer <NUM>, and wound sealing film <NUM> (B) with the first cover layer <NUM> and second cover layer <NUM>.

In some aspects, moisture vapor transmission rate (MVTR) of the wound sealing film <NUM>, <NUM>, <NUM>, <NUM> can be <NUM>/m<NUM>/<NUM> hours to <NUM>/m<NUM>/<NUM> hours or at least any one of, equal to any one of, or between any two of <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, <NUM>/m<NUM>/<NUM> hours, and <NUM>/m<NUM>/<NUM> hours. The wound sealing film <NUM>, <NUM>, <NUM>, <NUM> can also function as a barrier to liquids and microorganisms.

The wound sealing film <NUM>, <NUM>, <NUM>, <NUM> 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 <NUM>, <NUM>, <NUM>, <NUM> 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 <NUM>, <NUM>, <NUM>, <NUM> is configured to maintain a pressure differential at the tissue site and/or keep fluids from permeating through the wound sealing film <NUM>, <NUM>, <NUM>, <NUM> as described further with reference to <FIG>.

<FIG> shows a perspective view of an illustrative system <NUM> (e.g., a therapy system) for providing wound therapy. System <NUM> can include a wound sealing film <NUM> (shown), <NUM> (not shown), <NUM> (not shown), <NUM> (not shown), a therapy device <NUM>, a canister <NUM>, a tube <NUM>, and a dressing <NUM>. As an illustrative example, system <NUM> includes a wound sealing film <NUM>, <NUM>, <NUM>, <NUM> as part of dressing <NUM>.

System <NUM> is configured to provide therapy (e.g., oxygen therapy, positive-pressure therapy, negative-pressure therapy, or a combination thereof) at a tissue site <NUM> associated with a target area of a patient. For example, dressing <NUM> may be in fluid communication with tissue site <NUM> and may be in fluid communication with therapy device <NUM> via tube <NUM>. In some implementations, system <NUM> may include one or more components commercially available through and/or from KCI USA, Inc. of San Antonio, Tex. , and/or its subsidiary and related companies (collectively, "KCI").

Therapy device <NUM> (e.g., a treatment apparatus) is configured to provide therapy to tissue site <NUM> via tube <NUM> and dressing <NUM>. For example, therapy device <NUM> 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 <NUM>. As illustrative, non-limiting examples, positive-pressure applied to a tissue site may typically range between <NUM> millimeters mercury (mm Hg) (<NUM> pascals (Pa)) and <NUM> Hg (<NUM> kilo (k) Pa). Common therapeutic ranges are between <NUM> Hg (<NUM> kPa) and <NUM> Hg (<NUM> kPa). As illustrative, non-limiting examples, reduced-pressure applied to a tissue site may typically ranges between -<NUM> millimeters mercury (mm Hg) (-<NUM> pascals (Pa)) and -<NUM> Hg (-<NUM> kilo (k) Pa). Common therapeutic ranges are between -<NUM> Hg (-<NUM> kPa) and -<NUM> Hg (-<NUM> kPa).

In some implementations, therapy device <NUM> may alternate between providing positive-pressure therapy and negative-pressure therapy to the dressing <NUM>, may provide positive-pressure therapy to a first portion of the dressing <NUM> and negative-pressure therapy to a second portion of the dressing <NUM>, may provide no positive or negative pressure, or a combination thereof. In some such implementations, the therapy device <NUM> can provide positive-pressure therapy and negative-pressure therapy to the dressing <NUM> at the same time (e.g., partially concurrently).

As illustrated in <FIG>, therapy device <NUM> includes canister <NUM> to receive fluid from tissue site <NUM> or to provide fluid to tissue site <NUM>. Although canister <NUM> is illustrated as being internal to and/or integrated with therapy device <NUM>, in other implementations, canister <NUM> can be external to therapy device <NUM> (not shown).

Therapy device <NUM> 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 <NUM> may be configured to receive fluid, exudate, and or the like via dressing <NUM> and tube <NUM>. Therapy device <NUM> may include one or connectors, such as a representative connector <NUM>. Connector <NUM> is configured to be coupled to tube <NUM>. Additionally, or alternatively, therapy device <NUM> 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 <NUM> to monitor and/or sense a pressure associated with tube <NUM> and/or dressing <NUM>.

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

In some implementations, tube <NUM> 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 <NUM>), coupled to one or more valves, as an illustrative, non-limiting example. Although tube <NUM> is described as a single tube, in other implementations, system <NUM> may include multiple tubes, such as multiple distinct tubes coupled to therapy device <NUM>, dressing <NUM>, or both.

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

Dressing <NUM> includes a connector <NUM> (also referred to as a dressing connection pad or a pad), the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>), and a manifold <NUM> (also referred to as a distribution manifold or an insert or fluid manifold). The wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) may be coupled to connector <NUM>. To illustrate, the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) may be coupled to connector <NUM> via an adhesive, a separate adhesive drape over at least a portion of connector <NUM> and at least a portion of the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>), or a pressure sensitive adhesive, or a combination thereof, as illustrative, non-limiting examples.

The wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) may be configured to couple dressing <NUM> at tissue site <NUM> and/or to provide a seal to create an enclosed space (e.g., an interior volume) corresponding to tissue site <NUM>. For example, wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) 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 <NUM>, wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) is configured to maintain a pressure differential (provided by a positive-pressure source or a negative-pressure source) at tissue site <NUM>. The wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) may be configured to be coupled to tissue site <NUM> via the adhesive of the third layer <NUM>, <NUM> or combined layer <NUM>, <NUM>.

Referring to <FIG>, when in use, the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) is configured to be positioned on and/or near tissue site <NUM>, and may be secured at the tissue site <NUM>. When in use, the third layer <NUM>, <NUM> or combined layer <NUM>, <NUM> of the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) is configured to contact tissue site <NUM>.

Referring to <FIG>, manifold <NUM> is configured to be positioned on and/or near tissue site <NUM>, and may be secured at the tissue site <NUM>, such as secured by the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>). The manifold <NUM> 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 <NUM> 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 <NUM> 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.

In some implementations, manifold <NUM> 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 <NUM> 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.

In some implementations, manifold <NUM> 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 <NUM>, such as absorptive materials, wicking materials, hydrophobic materials, and hydrophilic materials. In an implementation in which the manifold <NUM> includes a hydrophilic material, manifold <NUM> may be configured to wick fluid away from tissue site <NUM> and to distribute positive-pressure to tissue site <NUM>. The wicking properties of manifold <NUM> may draw fluid away from the tissue site <NUM> 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. 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.

In some implementations, manifold <NUM> is constructed from bioresorbable materials that do not have to be removed from tissue site <NUM> following use of the system <NUM>. 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 <NUM> may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with manifold <NUM> 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 <NUM> is illustrated in <FIG>, in other implementations, dressing <NUM> does not include manifold <NUM>. In such implementations, wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) of dressing <NUM> is coupled to connector <NUM>.

Connector <NUM> can include a body <NUM> (e.g., a housing) and a base <NUM>, and can be configured to be coupled to tube <NUM> via an interface <NUM> (e.g., a port). Base <NUM> can be configured to be coupled to dressing <NUM>. For example, base <NUM> may be coupled, such as via an adhesive, and/or pressure to the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) and/or manifold <NUM>. In some implementations, base <NUM> comprises a flange that is coupled to an end of body <NUM> and/or is integrally formed with body <NUM>. Connector <NUM>, such as body <NUM>, base <NUM>, interface <NUM>, or a combination thereof, may be made of rigid material and/or a semi-rigid material. In a non-limiting example, connector <NUM> 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 <NUM> 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 <NUM> 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.

Body <NUM> includes one or more channels or one or more conduits that extend from and/or are coupled to interface <NUM>. To illustrate, body <NUM> may include a primary channel configured to be coupled in fluid communication with a primary lumen of tube <NUM>. The primary channel may be coupled to a cavity (e.g., a tissue cavity partially defined by body <NUM>) having an aperture open towards manifold <NUM> (and/or towards tissue site <NUM>). For example, the primary channel may include a first opening associated with interface <NUM> 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 <NUM> to enable fluid communication between interface <NUM> and tissue site <NUM>.

Body <NUM> includes a channel (e.g., a through channel) having a first aperture open opposite dressing <NUM> and a second aperture open towards dressing <NUM>. For example, the first aperture is located on an outer surface side (e.g., an ambient environment surface) of connector <NUM> and the second aperture is located on an inner surface side (e.g., a tissue facing side) of connector <NUM>. Illustrative, non-limiting examples of commercially available connectors include a "V. ® Pad," or "Sensa T. ® Pad" available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex.

In some implementations. dressing <NUM> 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.

During operation of system <NUM>, dressing <NUM> is coupled to tissue site <NUM> over a wound. Additionally, dressing <NUM> is coupled to device <NUM> via tube <NUM>. In some implementations, prior to coupling the dressing <NUM> to the tissue site <NUM>, a manifold <NUM> is coupled to tissue site <NUM> proximate to or over the wound. The dressing <NUM> with the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) is then coupled over the manifold <NUM> to seal the wound. In some aspects, an aperture <NUM> can be made in the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) over the manifold, where the aperture <NUM> that extends through wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) enables a fluid communication between therapy device <NUM> and the wound in the tissue site through the manifold <NUM>. In some aspects, the wound sealing film <NUM> (or <NUM> or <NUM> or <NUM>) can have a preformed aperture <NUM>, wherein the aperture is placed over a manifold <NUM> over a wound. In some aspects, a wound contact layer (not shown) is placed between the wound surface a the manifold.

Claim 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 an adhesive; and
a third layer having a first surface and a second surface, said third layer comprising a polymeric gel,
wherein the second layer is positioned between the first layer and the third layer,
the third layer comprising a plurality of perforations defined by ribs having an average cross-section length parallel to the first surface and the second surface of the third layer of between <NUM> to <NUM>.