Patent Application
20230088196
Aspects of the present disclosure relate generally to a compound film. In particular, the invention concerns a composite film containing a first polymer layer, second adhesive layer and a third gel layer, system and method for forming the compound film and method of using the compound film for a dressing of a wound therapy system. In some aspects, the second adhesive layer and the third gel layer can be combined to form a combined gel adhesive layer.
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.
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. The drape can form a highly conformable, flow-able sealing system that can seal creases and leaks. The drape can provide a high bond strength suitable for wound therapy, including negative pressure wound therapy with infusion. In some embodiments, the drape can be color changing to indicate when the adhesive and/or polymer gel has been exposed to electromagnetic energy that increases or decreases the tackiness of the adhesive and/or polymer gel. The drape can have a high moisture vapor transfer rate over the entire surface of the drape. Also, the drape can provide said benefits at a lower cost than other 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.
Certain embodiments are directed to a wound sealing film. In some aspects, the wound sealing film can include a first layer containing a first polymer, a second layer containing an adhesive and a third layer containing a polymeric gel. 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.
The third layer can contain a plurality of perforations through, or partially through, the third 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 third 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 third 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 third 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 third 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 third layer can form a web like pattern. In some aspects, the plurality of perforations of the third layer can form a repetitive pattern. In some aspects, the plurality of perforations of the third 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 third layer based on the length and width of the third layer. In some instances, the plurality of perforations of the third layer forms 25% to 98% of the surface area of the third layer based on the length and width of the third layer. In some aspects, the surface area of the third layer can be the area of the first and/or second surface of the third layer.
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 areal 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.
The adhesive of the second layer can be a high tack adhesive and/or light-switchable adhesive. The adhesive of the second layer can, in some instances, decreases or increases in tackiness when exposed to an electromagnetic energy, such as ultraviolet (UV) light. The bond strength to steel of the adhesive of the second layer can be 10, 11, 12, 13, 14, 15, 16, 17, 18 N/25 mm or any range thereof or strength therein, such as 10 to 18, 11 to 17, 12 to 16, or 14 to 16 N/25 mm. In some instances, this is the bond strength after or before the adhesive is exposed to the electromagnetic energy. The bond strength to steel of the adhesive of 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, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, 3, 3.2, 3.4, 3.6, 3.8, 4, 4.2, 4.4, 4.6, 4.8, 5 or any range thereof or strength therein, such as 0.1 to 5, 0.2 to 4, or 0.3 to 3 N/25 mm, after or before the adhesive is exposed to the electromagnetic energy. In some instances, exposure to UV light causes crosslinking of polymers in the adhesive of the second layer, which crosslinking decreases the tackiness of the adhesive. The adhesive of the second layer can, in some instances, change color when exposed to the electromagnetic energy. In some instances, the adhesive can change from fluorescing blue under UV light to fluorescing violet under UV light after being exposed to UV light for 10 seconds or less. In some instances, the adhesive is an acrylic adhesive. In some instances, the adhesive further contains a radical polymerizable pre-polymer and a photo-initiator. In some aspects, the second 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 second layer can have an areal weight of 30 to 100 grams per square meter (gsm), 40 to 90 gsm, 45 to 80 gsm, or 50 to 70 gsm. The areal weight of the second layer can be 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 gsm or any range thereof or weight therein. In some aspects, the second layer can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours. In some aspects, the second layer can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours, greater than 500 g/m2/24 hours, greater than 600 g/m2/24 hours, greater than 700 g/m2/24 hours, greater than 750 g/m2/24 hours, or at least 800 g/m2/24 hours. The moisture vapor transfer rate of the second layer can be 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1100, 1200, 1300, 1400, 1500, 2000 g/m2/24 hours or any range thereof or weight therein. In some aspects, the second 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).
In some aspects, the polymeric gel of the third layer can contain 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 or increases in tackiness when exposed to an electromagnetic energy, such as ultraviolet light. The bond strength to steel of the third layer can be 1, 2, 3, 4, 5, 6, or 7 N/25 mm or any range thereof or strength therein, such as 1 to 7, 2 to 6, 3 to 5, or 3 to 6 N/25 mm. In some instances, this is the bond strength after or before the third layer is exposed to the electromagnetic energy. The bond strength to steel of the third layer can be 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.12, 0.14, 0.16, 0.18, 0.2, 0.22, 0.24, 0.26, 0.28, 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, 0.44, 0.46, 0.48, 0.5 or any range thereof or strength therein, such as 0.01 to 0.5, 0.05 to 0.4, or 0.08 to 0.3 N/25 mm, after or before the adhesive is exposed to the electromagnetic energy. In some instances, the third layer has a bond strength that is less than the bond strength of the adhesive of the second layer. In some instances, the third layer has a bond strength that is less than the bond strength of the adhesive of the second layer after or before the third layer is exposed to the electromagnetic energy. In some instances, exposure to UV light causes crosslinking of polymers in the third layer, which crosslinking decreases the tackiness of the third layer. The third layer can, in some instances, change color when exposed to the electromagnetic energy. In some instances, the third layer can change from fluorescing blue under UV light to fluorescing violet under UV light after being exposed to UV light for 10 seconds or less. In some instances, the third layer contains a radical polymerizable pre-polymer and a photo-initiator. In some aspects, the polymeric gel of the third 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 third layer can contain thermoplastic elastomers such as poly(styrene-butadiene-styrene) SEBs. In some aspects, the polymeric gel of the third 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 a 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. 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 plasticizers that are useful in the current invention include but are not limited to naphthenic plasticizers commercially available under the brand name SHELL EDELEX OIL sold by SHELL.
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 water non-sensitive polymer, the first particle and optionally the plasticizer. In some aspects, the third 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 third 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 third 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 third layer can have an areal weight of 40 to 300 grams per square meter (gsm), 100 to 250 gsm, 100 to 200 gsm, 50 to 250 gsm, or 50 to 200 gsm. The areal weight of the third layer can be 40, 50, 60, 70, 80, 90, 100, 120, 140, 150, 160, 180, 190, 200, 210, 220, 240, 250, 260, 280, or 300 gsm or any range thereof or weight therein. 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 moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours, greater than 500 g/m2/24 hours, greater than 600 g/m2/24 hours, greater than 700 g/m2/24 hours, greater than 750 g/m2/24 hours, or at least 800 g/m2/24 hours. The moisture vapor transfer rate of the third layer can be 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1100, 1200, 1300, 1400, 1500, 2000 g/m2/24 hours or any range thereof or weight therein. In some aspects, the third 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, 1.4 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 third 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 as measured by ASTM D2240 using a shore durometer, or any range thereof or hardness therein. In some instances, the average hardness is 10 to 50 Shore 00 as measured by ASTM D2240 using a shore durometer. In some aspects, the third layer can be a transparent layer.
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 second layer and/or 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 second layer and/or the third layer can be a light-switchable adhesive and the second cover layer can be a light blocking layer.
In some aspects, the second layer and the third layer can form one single layer. The wound sealing film can include a first layer containing a first polymer, and a combined layer containing an adhesive, such as the adhesive of the second layer described above, and a polymeric gel, such as the polymeric gel of the third layer described above. The first layer can have a first surface and a second surface. The combined 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 combined layer. In some aspects, the combined layer can include a homogenous mixture of the polymeric gel and the adhesive.
The combined layer can contain a plurality of perforations through, or partially through, the combined layer, such as the perforations described above for the third 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 combined 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 combined 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 combined 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 combined 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 combined layer can form a web like pattern. In some aspects, the plurality of perforations of the combined layer can form a repetitive pattern. In some aspects, the plurality of perforations of the combined 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 combined layer based on the length and width of the combined layer. In some instances, the plurality of perforations of the combined layer forms 25% to 98% of the surface area of the combined layer based on the length and width of the combined layer. In some aspects, the surface area of the combined layer can be the area of the first and/or second surface of the combined layer.
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 areal 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.
The adhesive of the combined layer can be a high tack adhesive and/or light-switchable adhesive, such as one that increases or decreases in tackiness when exposed to electromagnetic energy, such as ultraviolet light. In some instances, the adhesive of the combined layer is any of the adhesives described above for the second layer adhesive. In some instances, exposure to UV light causes crosslinking of polymers in the adhesive, which crosslinking decreases the tackiness of the adhesive.
The adhesive can, in some instances, change color when exposed to the electromagnetic energy. In some instances, the adhesive can change from fluorescing blue under UV light to fluorescing violet under UV light after being exposed to UV light for 10 seconds or less. In some instances, the adhesive is an acrylic adhesive. In some instances, the adhesive further contains a radical polymerizable pre-polymer and a photo-initiator. In some aspects, the polymeric gel of the combined layer can be any of the polymeric gels described above for the third layer. In some aspects, the polymeric gel of the combined layer can contain 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 or increase in tackiness when exposed to ultraviolet energy, such as ultraviolet light. In some instances, exposure to UV light causes crosslinking of polymers in the polymeric gel, which crosslinking decreases the tackiness of the polymeric gel. The polymeric gel can, in some instances, change color when exposed to the electromagnetic energy. In some instances, the polymeric gel can change from fluorescing blue under UV light to fluorescing violet under UV light after being exposed to UV light for 10 seconds or less. In some instances, the polymeric gel contains a radical polymerizable pre-polymer and a photo-initiator. In some aspects, the polymeric gel of the combined 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 combined layer can contain thermoplastic elastomers such as poly(styrene-butadiene-styrene) SEBs. In some aspects, the polymeric gel of the combined 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. 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 a 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 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 water non-sensitive polymer, the first particle and optionally the plasticizer. In some aspects, the combined layer can have a water absorption rate of 0.01, 0.05, 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12 g/g or any range thereof or rate therein, such as 0.1 g/g to 10 g/g.
In some aspects, the combined 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, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3 mm, or any range thereof or thickness therein thick. In some instances, the average thickness is 0.1 mm to 2 mm thick. In some aspects, the combined layer can have a bond strength to steel of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 N/25 mm or any range thereof or strength therein, such as 1 to 20, 5 to 15, 7 to 15, 7 to 14, 9 to 14, 8 to 14, 8 to 12, or 8 to 10 N/25 mm. In some aspects, the combined layer can have a dry adhesive strength of 0.01, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 N/25 mm or any range thereof or strength therein, such as 1 to 20, 5 to 15, 7 to 15, 7 to 14, 9 to 14, 8 to 14, 8 to 12, or 8 to 10 N/25 mm. In some aspects, moist adhesive strength of the combined layer can be 15% to 100%, 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%, 75%, 80%, 85%, 90%, 95%, or 100% of the dry adhesive strength of the combined layer. In some instances, this is the bond strength after or before the combined layer is exposed to the electromagnetic energy. The bond strength to steel of the combined layer can be 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, 3, N/25 mm or any range thereof or strength therein, such as 0.01 to 3, 0.5 to 2.5, or 1 to 2 N/25 mm, after or before the combined layer is exposed to the electromagnetic energy. In some aspects, the combined layer can have a density of 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6 g/cc or any range thereof or rate therein, such as 0.9 g/cc to 1.5 g/cc. In some aspects, the combined layer can be have a thickness of 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 mm or any range thereof or thickness therein, such as 0.1 mm to 1.2 mm. In some aspects, the combined layer can have a hardness of 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 Shore 00 or any range thereof or hardness therein such as 10 to 50 Shore 00 as measured by ASTM D2240 using a shore durometer. In some aspects, the combined layer can have an areal weight of 50, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300 grams per square meter (gsm) or any range thereof or areal weight therein such as 100 to 1200 gsm. In some aspects, the combined layer can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours. In some aspects, the combined layer can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours, greater than 500 g/m2/24 hours, greater than 600 g/m2/24 hours, greater than 700 g/m2/24 hours, greater than 750 g/m2/24 hours, or at least 800 g/m2/24 hours. The moisture vapor transfer rate of the combined layer can be 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1100, 1200, 1300, 1400, 1500, 2000 g/m2/24 hours or any range thereof or weight therein. In some aspects, the combined layer can have a viscosity which produces cone penetration of 5, 6, 7, 8, 9, 10, 11, 12 mm or any range thereof or cone penetration therein such 7 mm to 11 mm of cone penetration according to ISO 2137 (e.g., 70 mm/10 to 110 mm/10). In some aspects, the combined layer can be a transparent layer.
In some aspects, the wound sealing film with at least two layers 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 and/or the polymer gel of the combined 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 combined layer. In some aspects, the second cover layer can be a light blocking layer. In some particular aspects, the adhesive and/or the polymer gel of the combined layer can be a light-switchable adhesive and the second cover layer can be a light blocking layer.
In some instances, the wound sealing film with the second and third layer or with the combined layer can have a bond strength to steel of 7, 8, 9, 10, 11, 12, 13, 14, 15 N/25 mm or any range thereof or strength therein, such as 7 to 15, 7 to 14, 9 to 14, 8 to 14, 8 to 12, or 8 to 10 N/25 mm. In some instances, this is the bond strength after or before the second, third, or combined layer is exposed to the electromagnetic energy. The bond strength to steel of the wound sealing film can be 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, 3, or any range thereof or strength therein, such as 0.01 to 3, 0.5 to 2.5, or 1 to 2 N/25 mm, after or before the second, third, or combined layer is exposed to the electromagnetic energy. In some aspects, the wound sealing film can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours. In some aspects, the wound sealing film can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours, greater than 500 g/m2/24 hours, greater than 600 g/m2/24 hours, greater than 700 g/m2/24 hours, greater than 750 g/m2/24 hours, or at least 800 g/m2/24 hours. In some aspects, the wound sealing film can have a 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. In some embodiments, the drape has an MVTR of over 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, such as over 800 g/m2/24 hours over the entire drape, such as in the perforations and the non-perforated sections of the third layer and/or combined layer.
Certain embodiments are directed to a method of producing a wound sealing film. The wound sealing film can be any one of the wound sealing films disclosed herein. In some aspects, the method can include (i) providing the first layer having a first surface and a second surface, said first layer can contain a first polymer composition, (ii) coupling the second layer having a first surface and a second surface with the first layer, said second layer can contain an adhesive; and (iii) coupling the third layer having a first surface and a second surface with the second layer, said third layer can contain a polymeric gel. 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 the adhesive on the second surface of the first layer to form the second layer. In some aspects, the coupling of the third layer with the second layer can include casting a polymer gel precursor on the second surface of the second layer and curing the polymer gel precursor. In some aspects, the coupling of the third layer with the second layer can include casting a polymeric gel on the second surface of the second layer. In some aspects, the coupling of the third layer with the second layer can include laminating the third 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 method can include forming a plurality of perforations through or partially 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 and/or partially through the third layer. In some aspects, 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.
In some aspects, the wound sealing film can be prepared by a method including coupling the first layer having a first surface and a second surface, said first layer can contain a first polymer composition, with the combined layer having a first surface and a second surface, said combined layer can contain an adhesive and a polymeric gel. In some aspects, the first surface of the combined layer contacts the second surface of the first layer.
In some aspects, the coupling of the combined layer with the first layer can include casting the combined layer on the second surface of the first layer. In some aspects, the coupling of the combined layer with the first layer can include casting a combined layer precursor on the second surface of the first layer and curing the precursor. In some aspects, the coupling of the combined layer with the first layer can include laminating the combined layer on the second surface of the first layer. In some aspects, a preformed combined layer can be laminated on the second surface of the first layer.
In some aspects, the method can include forming a plurality of perforations through or partially through the combined layer. In some aspects, the plurality of the perforations of the combined layer can be formed by punching, cutting, drilling, dissolving, and/or melting one or more perforations through and/or partially through the combined layer. In some aspects, the perforations can be formed in the combined layer by casting or forming the combined layer on a mold or by printing or casting the third layer to form perforations.
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. In some aspects, 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. In some aspects, the second surface of the combined 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 combined layer prior to contacting the second surface of the combined layer with the skin of the subject.
Certain embodiments are directed to a method of treating a wound. The method can include sealing a wound site with a wound sealing film of the current invention and applying a pressure differential to a wound in the wound site through an aperture in the wound sealing film. 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.
Certain embodiments are directed to a wound therapy system. The wound therapy system can include a wound sealing film 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 film and between the source of negative and/or positive pressure and the fluid manifold.
Certain embodiments are directed to a kit comprising a wound sealing film 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 film and between a source of negative and/or positive pressure and the fluid manifold.
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.
The average cross-sectional length of the plurality of perforations of a layer refers to an average of lengths of the individual perforations along a surface (such as the first or the second surface) of the layer.
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 0.1, 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.
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.
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.”
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.
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.
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.
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.
The plurality of perforations 210 of the third layer 203 can contain perforations of any suitable shape and size. In some aspects, the plurality of perforations 210 of the third layer 203 can contain perforations of similar shape and/or size. In some aspects, the plurality of perforations 210 of the third layer 203 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 210 of the third layer 203 can have an average cross-sectional length 212 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 third layer 203 forms ribs 250 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 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 of the third layer 203 can form a repetitive pattern. In some aspects, the plurality of perforations 210 of the third layer 203 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 third layer 203. The adjacent perforations of the plurality of the perforations 210 of the third layer 203 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 427 of the combined layer 423 can contain perforations of any suitable shape and size. In some aspects, the plurality of perforations 427 of the combined layer 423 can contain perforations of similar shape and/or size. In some aspects, the plurality of perforations 427 of the combined layer 423 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 427 of the combined layer 423 can have an average cross-sectional length 428 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 combined layer 403 forms ribs 429 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 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 427 of the combined layer 423 can form a repetitive pattern. In some aspects, the plurality of perforations 427 of the combined layer 423 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 combined layer 423. The adjacent perforations of the plurality of the perforations 427 of the combined layer 423 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 first layer 101, 201, 301, 401 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 101, 201, 301, 401 can be formed from a polyurethane film. In some particular aspects, the first layer 101, 201, 301, 401 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, 413 of the first layer 101, 201, 301, 401 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, 401 can have a real 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.
The second layer 102, 202 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 114, 214 of the second layer 102, 202 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. In some aspect, the light-switchable adhesive can be a light-switchable adhesive as described in U.S. Provisional Application 62/858,089 by Locke et al., which is incorporated herein by reference.
In some aspects, the third layer 103, 203 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 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. In some aspects, the third layer 103, 203 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 third layer 103, 203 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 third layer 103, 203 can be 15% to 100%, 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%, 75%, 80%, 85%, 90%, 95%, or 100% of the dry adhesive strength of the second layer 102, 202, 302. In some aspects, the third layer 103, 203 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 115, 215 of the third layer 103, 203 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 third layer 103, 203 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, as measured by ASTM D2240 using a shore durometer. In some aspects, the third layer 103, 203 can be a transparent layer.
The combined layer 323, 423 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 323, 423 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 U.S. provisional application 62/858,089 by Locke et al., which is incorporated herein by reference. 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.
In some aspects, the combined layer 323, 423 can have a water absorption rate of 0.05, 0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12 g/g or any range thereof or rate therein, such as 0.1 g/g to 10 g/g. In some aspects, the combined layer 323, 423 can have a bond strength to steel of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 N/25 mm or any range thereof or strength therein, such as 1 to 20, 5 to 15, 7 to 15, 7 to 14, 9 to 14, 8 to 14, 8 to 12, or 8 to 10 N/25 mm. In some aspects, the combined layer 323, 423 can have a dry adhesive strength of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 N/25 mm or any range thereof or strength therein, such as 1 to 20, 5 to 15, 7 to 15, 7 to 14, 9 to 14, 8 to 14, 8 to 12, or 8 to 10 N/25 mm. In some aspects, moist adhesive strength of the combined layer 323, 423 can be 15% to 100%, 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%, 75%, 80%, 85%, 90%, 95%, or 100% of the dry adhesive strength of the combined layer 323, 423. In some aspects, the combined layer 323, 423 can have a density of 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6 g/cc or any range thereof or rate therein, such as 0.9 g/cc to 1.5 g/cc. In some aspects, width or thickness 326, 426 of the combined layer 323, 423 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, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3 mm, or any range thereof or thickness therein thick, such as 0.1 mm to 2 mm thick. In some aspects, the combined layer 323, 423 can have a hardness of 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 Shore 00 or any range thereof or hardness therein such as 10 to 50 Shore 00 as measured by ASTM D2240 using a shore durometer. In some aspects, the combined layer 323, 423 can have an areal weight of 50, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300 grams per square meter (gsm) or any range thereof or areal weight therein such as 100 to 1200 gsm. In some aspects, the combined layer 323, 423 can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours. In some aspects, the combined layer can have a moisture vapor transfer rate (MVTR) of greater than 250 g/m2/24 hours, greater than 500 g/m2/24 hours, greater than 600 g/m2/24 hours, greater than 700 g/m2/24 hours, greater than 750 g/m2/24 hours, or at least 800 g/m2/24 hours. The moisture vapor transfer rate of the combined layer can be 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1100, 1200, 1300, 1400, 1500, 2000 g/m2/24 hours or any range thereof or weight therein. In some aspects, the combined layer 323, 423 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 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.
The wound sealing film 100, 200, 300, 400 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, 404 of the first layer 101, 201, 301, 401. The second cover layer can contact the second surface 109, 209 of the third layer 103, 203 or the second surface 325, 425 of the combined layer 323, 423.
In some aspects, moisture vapor transmission rate (MVTR) of the wound sealing film 100, 200, 300, 400 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, 400 can also function as a barrier to liquids and microorganisms.
The wound sealing film 100, 200, 300, 400 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, 400 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, 400 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, 400 as described further with reference to
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”).
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).
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).
As illustrated in
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.
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.
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.
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.
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 or 400), and a manifold 634 (also referred to as a distribution manifold or an insert or fluid manifold). The wound sealing film 100 (or 200 or 300 or 400) may be coupled to connector 630. To illustrate, the wound sealing film 100 (or 200 or 300 or 400) 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 400), or a pressure sensitive adhesive, or a combination thereof, as illustrative, non-limiting examples.
The wound sealing film 100 (or 200 or 300 or 400) 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 or 400) 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 or 400) 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 or 400) may be configured to be coupled to tissue site 620 via the adhesive of the third layer 103, 203 or combined layer 323, 423.
Referring to
Referring to
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.
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.
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
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 or 400) 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.
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., a tissue 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.
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., a tissue 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.
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.
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 or 400) 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 or 400) over the manifold, where the aperture 670 that extends through wound sealing film 100 (or 200 or 300 or 400) 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 film 100 (or 200 or 300 or 400) 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.
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.
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.
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.
This application claims the benefit of priority to U.S. Provisional Application No. 62/933,688, filed on Nov. 11, 2019, which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/060619 | 11/11/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62933688 | Nov 2019 | US |
