WO2021014356A1

WO2021014356A1 - Foam compositions for wound treatment, systems of delivery, and methods of use

Info

Publication number: WO2021014356A1
Application number: PCT/IB2020/056852
Authority: WO
Inventors: Marisa Schmidt; Prathamesh Madhav KHARKAR; Sandra Osborne Garcia; Diwi ALLEN; Kathleen L. DERRICK; Kristine M. Kieswetter
Original assignee: Kci Licensing, Inc.
Priority date: 2019-07-23
Filing date: 2020-07-21
Publication date: 2021-01-28

Abstract

Foam compositions that may be delivered to complex wound architecture, systems for delivering such foam compositions, and methods of use are described. The foam composition includes about 0.1 wt.% to about 45 wt.% collagen with a weight average molecular weight of about 5,000 to about 100,000; about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC); a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant; about 50 wt.% to about 98 wt.% water; and a gas. In the foam composition, a weight ratio of collagen to ORC is about 90:10 to about 10:90 and the foam composition exhibits a foam capacity of about 20% to about 400%.

Description

P001596W001SEC

FOAM COMPOSITIONS FOR WOUND TREATMENT,

SYSTEMS OF DELIVERY, AND METHODS OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/877,587, filed on July 23, 2019, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The claimed subject matter relates generally therapy of a tissue site and, more particularly, but without limitation, to foam compositions, systems, and methods for facilitating wound healing.

BACKGROUND

[0003] A wide variety of materials and devices, generally characterized as“dressings,” are generally known in the art for use in treating an injury or other disruption of tissue. Such wounds may be the result of trauma, surgery, or disease, and may affect skin or other tissues. In general, dressings may control bleeding, absorb wound exudate, ease pain, assist in debriding the wound, protect wound tissue from infection, or otherwise promote healing and protect the wound from further damage.

[0004] Some dressings may protect tissue from, or even assist in the treatment of, infections associated with wounds. Infections can retard wound healing and, if untreated, can result in tissue loss, systemic infections, septic shock, and death. While the benefits of dressings are widely accepted, improvements to dressings may benefit healthcare providers and patients.

[0005] In particular, there is currently a need for products that conform to complex wound topographies upon application. Tunneling wounds are one example, where products available in sheet form cannot be readily delivered and/or tailored to the wound architecture.

SUMMARY

[0006] In an aspect, a foam composition is provided that includes about 0.1 wt.% to about 45 wt.% collagen with a weight average molecular weight of about 5,000 to about 100,000; about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC); a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant; about 50 wt.% to about 98 wt.% water; and a gas; wherein a weight ratio of collagen to ORC is about 90: 10 to about 10:90; and the foam composition exhibits a foam capacity of about 20% to about 400%. [0007] In a related aspect, a system for delivery of the foam composition to and/or within a wound is provided, where the system includes a mixture and a gas each disposed within an interior of a container, and a nozzle that includes an applicator tip in fluid communication with the interior of the container. In the system, at least the gas is pressurized to about 1.1 atmospheres (“atm”) to about 10 atm.

[0008] In a further related aspect, a method of treating a wound in a subject in need thereof is provided, where the method includes contacting the wound with a foam composition of any embodiment described herein and where the contacting comprises foaming a mixture to a foam capacity of about 20% to about 400%.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIGs. 1-8 provide block diagrams generally illustrating various non-limiting embodiments of a system for delivery of a foam composition to and/or within a wound according to the present technology, as further described herein.

[0010] It should be noted that the representative illustrations provided in the figures set forth herein is intended to illustrate the general features and/or characteristics of exemplary embodiments to aid in describing the present technology in full. The figures may not precisely reflect the

characteristics of any given embodiment, and are not necessarily intended to define or limit the scope of the claimed subject matter. Further, the present technology may or may not include or incorporate therewith any one or more features of characteristics set provided in any one or more figures.

DETAILED DESCRIPTION

[0011] The following terms are used throughout as defined below.

[0012] As used herein and in the appended claims, singular articles such as“a” and“an” and“the” and similar referents in the context of describing the elements (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g.,“such as”) provided herein, is intended merely to better illuminate the embodiments and does not pose a limitation on the scope of the claims unless otherwise stated. No language in the specification should be construed as indicating any non- claimed element as essential.

[0013] As used herein,“about” will be understood by persons of ordinary skill in the art and will vary to some extent depending upon the context in which it is used. If there are uses of the term which are not clear to persons of ordinary skill in the art, given the context in which it is used,“about” will mean up to plus or minus 10% of the particular term - for example,“about 10 wt.%” would be understood to mean“9 wt.% to 11 wt.%.” It is to be understood that when“about” precedes a term, the term is to be construed as disclosing“about” the term as well as the term without modification by “about” - for example,“about 10 wt.%” discloses“9 wt.% to 11 wt.%” as well as disclosing“10 wt.%.”

[0014] As will be understood by one skilled in the art, for any and all purposes, particularly in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etc. As will also be understood by one skilled in the art all language such as“up to,”“at least,”“greater than,”“less than,” and the like include the number recited and refer to ranges which can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 atoms refers to groups having 1, 2, or 3 atoms. Similarly, a group having 1-5 atoms refers to groups having 1, 2, 3, 4, or 5 atoms, and so forth.

[0015] The term“foam capacity” refers to the volume of a foam composition versus the volume of the mixture of components in the composition prior to generation of a foam (the“mixture”), e.g., through inclusion of a gas, as determined by the following formula: foam capacity = [(volume foam composition) -(volume mixture)]/[volume mixture] Eq. 1

[0016] The term“surfactant” is well understood by a person of ordinary skill in the art and includes compounds that lower the surface tension between two liquids, between a gas and a liquid, and/or between a liquid and a solid.

The Present Technology

[0017] The present technology provides foam compositions that may be delivered to complex wound architecture, systems for delivering such foam compositions, and methods of use. The present technology provide for quicker and easier-to-use delivery of compositions that facilitate wound healing and that are significantly more conformable and tailorable to complex wound architectures such as deep dermal wounds and diabetic wounds, unlike sheet dressing materials. The present technology allows for delivery of a foam composition that readily reaches the nooks and crannies of both simple wounds as well as, e.g., deep tunneling and/or irregularly contoured wounds.

[0018] Thus, in an aspect, a foam composition is provided that includes about 0.1 wt.% to about 45 wt.% collagen with a weight average molecular weight of about 5,000 to about 100,000; about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC); a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant; about 50 wt.% to about 98 wt.% water; and a gas; wherein a weight ratio of collagen to ORC is about 90: 10 to about 10:90; and the foam composition exhibits a foam capacity of about 20% to about 400%. The gas may include air, nitrogen, nitrous oxide, carbon dioxide, or a mixture of any two or more thereof. Water may be included at about 50 wt.%, about 52 wt.%, about 54 wt.%, about 56 wt.%, about 58 wt.%, about 60 wt.%, about 62 wt.%, about 64 wt.%, about 66 wt.%, about 68 wt.%, about 70 wt.%, about 72 wt.%, about 74 wt.%, about 76 wt.%, about 78 wt.%, about 80 wt.%, about 82 wt.%, about 84 wt.%, about 86 wt.%, about 88 wt.%, about 90 wt.%, about 91 wt.%, about 92 wt.%, about 93 wt.%, about 94 wt.%, about 95 wt.%, about 96 wt.%, about 97 wt.%, about 98 wt.%, or any range including and/or in between any two of these values. The foam composition of the present technology may provide a moist environment for a wound bed and assist with autolytic debridement.

[0019] The collagen of any embodiment herein may be a Type I collagen, a Type II collagen, a Type III collagen, may be obtained from any natural source, may be chemically-modified collagen (e.g., an atelocollagen obtained by removing the immunogenic telopeptides from natural collagen), or may be a combination of any two or more thereof. For example, the collagen may include collagen obtained from bovine corium that has been rendered largely free of non-collagenous components, for example, including fat, non-collagenous proteins, polysaccharides, and other carbohydrates, such as by procedures described in U.S. Pat. Nos. 4,614,794 and 4,320,201, each of which is incorporated herein by reference. The amount of collagen in the foam composition may be about 0.1 wt.%, about 0.2 wt.%, about 0.3 wt.%, about 0.4 wt.%, about 0.5 wt.%, about 0.6 wt.%, about 0.7 wt.%, about 0.8 wt.%, about 0.9 wt.%, about 1 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, about 6 wt.%, about 7 wt.%, about 8 wt.%, about 9 wt.%, about 10 wt.%, about 11 wt.%, about 12 wt.%, about 13 wt.%, about 14 wt.%, about 15 wt.%, about 16 wt.%, about 17 wt.%, about 18 wt.%, about 19 wt.%, about 20 wt.%, about 22 wt.%, about 24 wt.%, about 26 wt.%, about 28 wt.%, about 30 wt.%, about 32 wt.%, about 34 wt.%, about 36 wt.%, about 38 wt.%, about 40 wt.%, about 42 wt.%, about 44 wt.%, about 45 wt.%, or any range including and/or in between any two of these values. [0020] As described above, the collagen of any embodiment herein may include a weight-average molecular weight of about 5,000 to about 100,000; thus, the collagen may have a weight-average molecular weight of about 5,000, about 6,000, about 7,000, about 8,000, about 9,000, about 10,000, about 12,000, about 14,000, about 16,000, about 18,000, about 20,000, about 22,000, about 24,000, about 26,000, about 28,000, about 30,000, about 32,000, about 34,000, about 36,000, about 38,000, about 40,000, about 45,000, about 50,000, about 55,000, about 60,000, about 65,000, about 70,000, about 75,000, about 80,000, about 85,000, about 90,000, about 95,000, about 100,000, or any range including and/or in between any two of these values. As understood by one of ordinary skill in the art,“molecular weight” (also known as“relative molar mass”) is a dimensionless quantity but is converted to molar mass by multiplying by 1 gram/mole - for example, collagen with a weight- average molecular weight of 5,000 has a weight-average molar mass of 5,000 g/mol.

[0021] As disclosed previously, the foam compositions of the present technology include about 0.1 wt.% to about 45 wt.% ORC. The amount of ORC in the foam composition may be about 0.1 wt.%, about 0.2 wt.%, about 0.3 wt.%, about 0.4 wt.%, about 0.5 wt.%, about 0.6 wt.%, about 0.7 wt.%, about 0.8 wt.%, about 0.9 wt.%, about 1 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, about 6 wt.%, about 7 wt.%, about 8 wt.%, about 9 wt.%, about 10 wt.%, about 11 wt.%, about 12 wt.%, about 13 wt.%, about 14 wt.%, about 15 wt.%, about 16 wt.%, about 17 wt.%, about 18 wt.%, about 19 wt.%, about 20 wt.%, about 22 wt.%, about 24 wt.%, about 26 wt.%, about 28 wt.%, about 30 wt.%, about 32 wt.%, about 34 wt.%, about 36 wt.%, about 38 wt.%, about 40 wt.%, about 42 wt.%, about 44 wt.%, about 45 wt.%, or any range including and/or in between any two of these values. In any embodiment herein, the ORC may have a weight-average molecular weight of about 50,000 to about 1,000,000; thus, the ORC may have a weight-average molecular weight of about 50,000, about 100,000, about 150,000, about 200,000, about 250,000, about 300,000, about 350,000, about 400,000, about 450,000, about 500,000, about 550,000, about 600,000, about 650,000, about 700,000, about 750,000, about 800,000, about 850,000, about 900,000, about 950,000, about 1,000,000, or any range including and/or in between any two of these values. Oxidized regenerated cellulose may be produced by the oxidation of cellulose, for example with dinitrogen tetroxide and/or as described in U.S. Pat. No. 3,122,479 (incorporated herein by reference). Not intending to be bound by theory, this process may convert primary alcohol groups on the saccharide residues of the celluolse to carboxylic acid groups, for example, forming uronic acid residues within the cellulose chain. The oxidation may not proceed with complete selectivity, and as a result hydroxyl groups on carbons 2 and 3 of the saccharide residue may be converted to the keto form. These ketone units may introduce an alkali labile link, which at pH 7 or higher initiates the decomposition of the polymer via formation of a lactone and sugar ring cleavage. As a result, oxidized regenerated cellulose is biodegradable and bioabsorbable under physiological conditions. ORC is available with a variety of degrees of oxidation and hence rates of degradation. The ORC may include particles, fibers, or both; in any embodiment herein, the ORC may be in the form of particles, such as fiber particles or powder particles. In embodiments that include ORC fibers, the ORC fibers may have a volume fraction such that at least 80% of the fibers have lengths in the range from about 5 pm to about 1000 pm, preferably from about 250 pm to about 450 pm.

[0022] In the foam composition, a weight ratio of collagen to ORC is about 90: 10 to about 10:90 and the foam composition exhibits a foam capacity of about 20% to about 400%. The foam capacity of any embodiment herein may be about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 110%, about 120%, about 130%, about 140%, about 150%, about 160%, about 170%, about 180%, about 190%, about 200%, about 220%, about 240%, about 260%, about 280%, about 300%, about 320%, about 340%, about 360%, about 380%, about 400%, or any range including and/or in between any two of these values. The weight ratio of collagen to ORC of any embodiment herein may be about 90: 10, about 80:20, about 70:30, about 60:40, about 59:41, about 58:42, about 57:43, about 56:44, about 55:45, about 54:46, about 53:47, about 52:48, about 51:49, about 50:50, about 49:51, about 48:52, about 47:53, about 46:54, about 45:55, about 44:56, about 43:57, about 42:58, about 41:59, about 40:60, about 30:70, about 20:80, about 10:90, or any range including and/or in between any two of these values.

[0023] The rheology modifier may include a polyol, a polyacrylate, xanthan gum, guar gum, locust bean gum, gelatin, agar, carrageenan, pectin, starch, a starch derivative, or a combination of any two or more thereof. Exemplary polyols include, but are not limited to, polyethylene glycol, propylene glycol, polyvinyl alcohol, glycerin, maltitol, erythritol, sorbitol, and mannitol, as well as combinations of any two or more thereof. The rheology modifier of any embodiment herein may include a gelling agent, such as alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, agar, carrageenan, locust bean gum, pectin, gelatin, or a combination of any two or more thereof. In addition to other advantages, gelling agents may also serve facilitate management of wound fluid.

[0024] The surfactant may include one or more of an anionic surfactant, a cationic surfactant, a zwitterionic surfactant, and a non-ionic surfactant. For example, the surfactant may include sodium laureth sulfate (also known as sodium lauryl ether sulfate), sodium lauryl sulfate (also known as sodium dodecyl sulfate), ammonium lauryl sulfate, docusate (also known as dioctyl sulfosuccinate), or a combination of any two or more thereof. Anionic surfactants, cationic surfactants, and zwitterionic surfactants may be provided as pharmaceutically acceptable salts. Pharmaceutically acceptable salts are within the scope of the present technology and include acid or base addition salts which retain the desired activity and is not biologically undesirable (e.g., the salt is not unduly toxic, allergenic, or irritating, and is bioavailable). When the surfactant has a basic group, such as, for example, an amino group, pharmaceutically acceptable salts can be formed with inorganic acids (such as hydrochloric acid, hydroboric acid, nitric acid, sulfuric acid, and phosphoric acid), organic acids (e.g., alginate, formic acid, acetic acid, benzoic acid, gluconic acid, fumaric acid, oxalic acid, tartaric acid, lactic acid, maleic acid, citric acid, succinic acid, malic acid, methane sulfonic acid,

benzenesulfonic acid, naphthalene sulfonic acid, and /Molucncsulfonic acid) or acidic amino acids (such as aspartic acid and glutamic acid). When the surfactant has an acidic group, such as for example, a carboxylic acid group or a sulfonic acid group, it can form salts with metals, such as alkali and earth alkali metals (e.g., Na⁺, Li⁺, K⁺, Ca²⁺, Mg²⁺, Zn²⁺), ammonia or organic amines (e.g., dicyclohexylamine, trimethylamine, triethylamine, pyridine, picoline, ethanolamine, diethanolamine, triethanolamine) or basic amino acids (e.g., arginine, lysine and ornithine). Such salts can be prepared in situ during isolation and purification of the surfactant or by separately reacting the purified compound in its free base or free acid form with a suitable acid or base, respectively, and isolating the salt thus formed. For example, ducosate may be included as a sodium salt, a calcium salt, a potassium salt, or a combination of any two or more thereof for each surfactant.

[0025] As provided above, the total amount of rheology modifier(s) and surfactant(s) in the foam composition is about 0.001 wt.%, about 0.002 wt.%, about 0.003 wt.%, about 0.004 wt.%, about 0.005 wt.%, about 0.006 wt.%, about 0.007 wt.%, about 0.008 wt.%, about 0.009 wt.%, about 0.01 wt.%, about 0.02 wt.%, about 0.03 wt.%, about 0.04 wt.%, about 0.05 wt.%, about 0.06 wt.%, about 0.07 wt.%, about 0.08 wt.%, about 0.09 wt.%, about 0.1 wt.%, about 0.2 wt.%, about 0.3 wt.%, about 0.4 wt.%, about 0.5 wt.%, about 0.6 wt.%, about 0.7 wt.%, about 0.8 wt.%, about 0.9 wt.%, about 1 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, about 6 wt.%, about 7 wt.%, about 8 wt.%, about 9 wt.%, about 10 wt.%, about 11 wt.%, about 12 wt.%, about 13 wt.%, about 14 wt.%, about 15 wt.%, about 16 wt.%, about 17 wt.%, about 18 wt.%, about 19 wt.%, about 20 wt.%, about 22 wt.%, about 24 wt.%, about 26 wt.%, about 28 wt.%, about 30 wt.%, about 32 wt.%, about 34 wt.%, about 36 wt.%, about 38 wt.%, about 40 wt.%, about 42 wt.%, about 44 wt.%, about 46 wt.%, about 48 wt.%, about 50 wt.%, or any range including and/or in between any two of these values.

[0026] The foam composition of any embodiment herein may include about 0.001 wt.% to about 5 wt.% of an antimicrobial agent. Thus, the total amount of antimicrobial agent(s) in the foam composition may be about 0.001 wt.%, about 0.002 wt.%, about 0.003 wt.%, about 0.004 wt.%, about 0.005 wt.%, about 0.006 wt.%, about 0.007 wt.%, about 0.008 wt.%, about 0.009 wt.%, about 0.01 wt.%, about 0.02 wt.%, about 0.03 wt.%, about 0.04 wt.%, about 0.05 wt.%, about 0.06 wt.%, about 0.07 wt.%, about 0.08 wt.%, about 0.09 wt.%, about 0.1 wt.%, about 0.2 wt.%, about 0.3 wt.%, about 0.4 wt.%, about 0.5 wt.%, about 0.6 wt.%, about 0.7 wt.%, about 0.8 wt.%, about 0.9 wt.%, about 1 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, or any range including and/or in between any two of these values. The antimicrobial agent may include a penicillin, a streptomycin, ionic silver, chlorhexidine, a poly(hexamethylene biguanide) (PHMB), iodine, or a combination of any two or more thereof. Ionic silver may be provided in a variety of forms including as pharmaceutically acceptable salts, where representative examples include but are not limited to silver oxide, silver chromate, silver allantoinate, silver borate, silver glycerolate, silver nitrate, silver acetate, silver chloride, silver sulfate, silver lactate, silver bromide, silver iodide, silver carbonate, silver citrate, silver laurate, silver deoxycholate, silver salicylate, silver / aminobenzoate. silver p- aminosalicylate, or a combination of any two or more thereof. In addition, while initially

incorporated into the foam composition as a silver salt, at least a portion (if not substantially all) ionic silver may be complexed to the ORC in the foam composition.

[0027] The foam composition may include about 0.001 wt.% to about 5 wt.% of a wound healing promoter. Exemplary wound-healing promoters include, but are not limited to, an anti-inflammatory drug (e.g., acetaminophen), zinc, zinc oxide, an inorganic zinc salt (e.g., ZnCh), a zinc complex, vitamin E, vitamin C, a fibroblast growth factor, a platelet-derived growth factor (see, e.g., Gowda, Santosh, et al. "Topical application of recombinant platelet-derived growth factor increases the rate of healing and the level of proteins that regulate this response." International wound journal 12 5 (2015): 564-57), or a combination of any two or more thereof. The total amount of wound healing promoter(s) in the foam composition may be about 0.001 wt.%, about 0.002 wt.%, about 0.003 wt.%, about 0.004 wt.%, about 0.005 wt.%, about 0.006 wt.%, about 0.007 wt.%, about 0.008 wt.%, about 0.009 wt.%, about 0.01 wt.%, about 0.02 wt.%, about 0.03 wt.%, about 0.04 wt.%, about 0.05 wt.%, about 0.06 wt.%, about 0.07 wt.%, about 0.08 wt.%, about 0.09 wt.%, about 0.1 wt.%, about 0.2 wt.%, about 0.3 wt.%, about 0.4 wt.%, about 0.5 wt.%, about 0.6 wt.%, about 0.7 wt.%, about 0.8 wt.%, about 0.9 wt.%, about 1 wt.%, about 2 wt.%, about 3 wt.%, about 4 wt.%, about 5 wt.%, or any range including and/or in between any two of these values.

[0028] In any embodiment herein, it may be that the foam composition does not include a human- derived tissue. As well-understood by a person of ordinary skill in the art, a tissue includes cells as well as an associated extracellular matrix. In any embodiment herein, it may be the foam composition does not include an animal -derived tissue. The foam composition may optionally include a preservative, a stabilizing agent, a dyestuff, or a combination of any two or more thereof.

[0029] In a related aspect, a system is provided that advantageously provides for delivery of the foam composition to and/or within a wound. To aid in the present disclosure, FIGs. 1-8 provide block diagrams generally illustrating various non-limiting embodiments of a system of the present technology. The system includes a mixture 110 and a gas 120 each disposed within an interior of a container 100, and a nozzle 130 that includes an applicator tip 135 in fluid communication with the interior of the container. In the system, at least the gas 120 is pressurized to about 1.1 atmospheres (“atm”) to about 10 atm; in any embodiment herein, the mixture 110 may also be pressurized to about 1.1 atm to about 10 atm. Thus, the pressure in any embodiment herein may be about 1.1 atm, about 1.2 atm, about 1.3 atm, about 1.4 atm, about 1.5 atm, about 1.6 atm, about 1.7 atm, about 1.8 atm, about 1.9 atm, about 2.0 atm, about 2.2 atm, about 2.4 atm, about 2.6 atm, about 2.8 atm, about 3.0 atm, about 3.5 atm, about 4 atm, about 4.5 atm, about 5 atm, about 5.5 atm, about 6 atm, about 6.5 atm, about 7 atm, about 7.5 atm, about 8 atm, about 8.5 atm, about 9 atm, about 9.5 atm, about 10 atm, or any range including and/or in between any two of these values. The mixture 110 may be any embodiment described herein of the foam composition absent the foam capacity and optionally absent the gas of the foam composition. The gas 120 of the system may include air, nitrogen, nitrous oxide, carbon dioxide, or a mixture of any two or more thereof. The gas 120 may be contained in a first canister ( e.g ., canister 150 of FIGs. 2, 3, 4, and 7) within the interior of the container 100 or otherwise partitioned from the mixture 110 within the container 100 (e.g., FIGs. 5-6 via partition 160), where mixture 110 may or may not be contained in a second canister within the interior of the container 100 (e.g., canister 140 of FIGs. 3, 4, and 7); alternatively, the gas 120 and mixture 110 may be intermixed within the interior of the container 100 (e.g., FIG. 1). In any embodiment herein, the system may further include one or more gelling agents 170 which may be included in mixture 110 or which may be contained in a third canister within the interior of the container 100 (e.g. , canister 180 of FIG. 7). Suitable gelling agents are described previously in this disclosure. The first canister 150 (when present), the second canister 140 (when present), and the third canister 180 (when present), are each independently in fluid communication with the applicator tip 135 and the system configured to intermix, e.g., the one or more gelling agents, with the other contents of the container (e.g., intermix in the nozzle 130 as illustrated in FIGs. 4 and 6) upon use of the system to deliver the contents of the container.

[0030] In a related aspect, a method is provided that includes foaming a mixture to a foam capacity of about 20% to about 400%; wherein the mixture may be any embodiment described herein of the foam composition absent the foam capacity (e.g. , optionally absent the gas of the foam composition, or including gas and pressurized to about 1.1 atm to about 10 atm prior to the foaming step (a“pressurized mixture”)). Such a method as described herein may also be referred to as a “method of generating.” The pressurized mixture may be pressurized to about 1.1 atm, about 1.2 atm, about 1.3 atm, about 1.4 atm, about 1.5 atm, about 1.6 atm, about 1.7 atm, about 1.8 atm, about 1.9 atm, about 2.0 atm, about 2.2 atm, about 2.4 atm, about 2.6 atm, about 2.8 atm, about 3.0 atm, about 3.5 atm, about 4 atm, about 4.5 atm, about 5 atm, about 5.5 atm, about 6 atm, about 6.5 atm, about 7 atm, about 7.5 atm, about 8 atm, about 8.5 atm, about 9 atm, about 9.5 atm, about 10 atm, or any range including and/or in between any two of these values. In either regard, the foaming step of the method may further include gas injection of the mixture and/or releasing the pressure from the pressurized mixture. [0031] The method of any embodiment herein may include performing the foaming step within a wound in a patient. The wound may be a tunneling wound, a dermal wound, a diabetic wound, or a combination of any two or more thereof.

[0032] In a related aspect, a method of treating a wound in a subject in need thereof is provided, where the method includes contacting the wound with a foam composition of any embodiment described herein and where the contacting comprises foaming a mixture to a foam capacity of about 20% to about 400%. As used herein, a“subject” or“patient” is a mammal, such as a cat, dog, rodent or primate. Typically the subject is a human, and, preferably, a human suffering from a wound. The term“subject” and“patient” can be used interchangeably. The foam composition may be any embodiment described herein of the foam composition; mixture may be any embodiment described herein of the foam composition; the mixture may be any embodiment described herein of the foam composition absent the foam capacity (e.g. , optionally absent the gas of the foam composition, or including gas and pressurized to about 1.1 atm to about 10 atm prior to the foaming step (a “pressurized mixture”)). The contacting may include injecting the foam composition or the mixture within the wound. The foaming may include gas injection of the foam composition or the mixture, and/or may include releasing the pressure from the pressurized mixture. In any embodiment herein of the method, the wound may be a tunneling wound, a dermal wound, a diabetic wound, or a combination of any two or more thereof.

[0033] In a further related aspect, a kit is provided for generating a foam composition of any embodiment described herein, where the kit includes about 0.1 wt.% to about 45 wt.% collagen with a weight average molecular weight of about 5,000 to about 100,000; about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC); a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant, where a weight ratio of collagen to ORC is about 90: 10 to about 10:90 (the“starting mixture”). The kit also includes instructions for generating a foam composition of any embodiment described herein. The instructions may include directions to mix at least about 50 wt.% to about 98 wt.% water with the starting mixture to generate a slurry prior to generating the foam composition. The instructions may include directions to include a gas in the slurry to produce the foam composition. The instructions of any embodiment of a kit of the present technology may provide for a method of generating of any embodiment described herein. The instructions of any embodiment of a kit of the present technology may provide for a method of treating a wound in a subject in need thereof of any embodiment described herein.

[0034] The examples herein are provided to illustrate advantages of the present technology and to further assist a person of ordinary skill in the art with preparing or using the compositions and systems of the present technology. The examples should in no way be construed as limiting the scope of the present technology, as defined by the appended claims. The examples can include or incorporate any of the variations, aspects, or embodiments of the present technology described above. The variations, aspects, or embodiments described above may also further each include or incorporate the variations of any or all other variations, aspects or embodiments of the present technology.

[0035] While certain embodiments have been illustrated and described, a person with ordinary skill in the art, after reading the foregoing specification, can effect changes, substitutions of equivalents and other types of alterations to the compositions, systems, and methods of the present technology. Each aspect and embodiment described above can also have included or incorporated therewith such variations or aspects as disclosed in regard to any or all of the other aspects and embodiments.

[0036] The present technology is also not to be limited in terms of the particular aspects described herein, which are intended as single illustrations of individual aspects of the present technology.

Many modifications and variations of this present technology can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods within the scope of the present technology, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. It is to be understood that this present technology is not limited to particular methods, reagents, compounds, compositions, labeled compounds or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to be limiting. Thus, it is intended that the specification be considered as exemplary only with the breadth, scope and spirit of the present technology indicated only by the appended claims, definitions therein and any equivalents thereof.

[0037] The embodiments, illustratively described herein may suitably be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. Thus, for example, the terms“comprising,”“including,”“containing,” etc. shall be read expansively and without limitation. Additionally, the terms and expressions employed herein have been used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the claimed technology.

Additionally, the phrase“consisting essentially of’ will be understood to include those elements specifically recited and those additional elements that do not materially affect the basic and novel characteristics of the claimed technology. The phrase“consisting of’ excludes any element not specified. [0038] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group. Each of the narrower species and subgeneric groupings falling within the generic disclosure also form part of the invention. This includes the generic description of the invention with a proviso or negative limitation removing any subject matter from the genus, regardless of whether or not the excised material is specifically recited herein.

[0039] As will be understood by one skilled in the art, for any and all purposes, particularly in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etc. As will also be understood by one skilled in the art all language such as“up to,”“at least,”“greater than,”“less than,” and the like, include the number recited and refer to ranges which can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member.

[0040] All publications, patent applications, issued patents, and other documents (for example, journals, articles and/or textbooks) referred to in this specification are herein incorporated by reference as if each individual publication, patent application, issued patent, or other document was specifically and individually indicated to be incorporated by reference in its entirety. Definitions that are contained in text incorporated by reference are excluded to the extent that they contradict definitions in this disclosure.

[0041] Other embodiments are set forth in the following claims, along with the full scope of equivalents to which such claims are entitled.

Claims

What is claimed is:

1. A system for delivery of a foam composition, the system comprising

a mixture and a gas each disposed within an interior of a container; and

a nozzle comprising an applicator tip in fluid communication with the interior of the

container;

wherein at least the gas is pressurized to about 1.1 atm to about 10 atm; and

wherein the mixture comprises

about 0.1 wt.% to about 45 wt.% collagen with a weight average molecular weight of about 5,000 to about 100,000;

about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC);

a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant; and

about 50 wt.% to about 98 wt.% water;

wherein a weight ratio of collagen to ORC is about 90: 10 to about 10:90.

2. The system of Claim 1, wherein the gas is contained in a canister within the interior of the

container.

3. The system of Claim 1, wherein the gas and mixture are intermixed within the interior of the container.

4. The system of any one of Claims 1-3, wherein the weight ratio of collagen to ORC is about 60:40 to about 40:60.

5. The system of any one of Claims 1-4, wherein the rheology modifier comprises one or more of a polyol, a polyacrylate, xanthan gum, guar gum, locust bean gum, gelatin, agar, carrageenan, pectin, starch, and a starch derivative.

6. The system of any one of Claims 1-5, wherein the rheology modifier comprises a gelling agent.

7. The system of any one of Claims 1-6, wherein the rheology modifier comprises one or more

gelling agents selected from the group consisting of alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, agar, carrageenan, locust bean gum, pectin, and gelatin.

8. The system of any one of Claims 1-7, wherein the surfactant comprises one or more of an anionic surfactant, a cationic surfactant, a zwitterionic surfactant, and a non-ionic surfactant.

9. The system of any one of Claims 1-8, wherein the rheology modifier comprises one or more polyols selected from the group consisting of a polyethylene glycol, propylene glycol, polyvinyl alcohol, glycerin, maltitol, erythritol, sorbitol, and mannitol.

10. The system of any one of Claims 1-9, wherein the foam composition further comprises about

0.001 wt.% to about 5 wt.% of an antimicrobial agent.

11. The foam composition of any one of Claims 1-8, wherein the antimicrobial agent comprises one or more of ionic silver, chlorhexidine, and iodine.

12. The system of any one of Claims 1-10, wherein the foam composition further comprises about

0.001 wt.% to about 5 wt.% of a wound healing promoter.

13. The system of Claim 12, wherein the wound-healing promoter comprises one or more of zinc, zinc oxide, a zinc complex, vitamin E, and vitamin C.

14. The system of any one of Claims 1-13, wherein the foam composition does not comprise a

human-derived tissue.

15. The system of any one of Claims 1-14, wherein the foam composition does not comprise an animal-derived tissue.

16. The system of any one of Claims 1-15, wherein the foam composition exhibits a foam capacity of about 100% to about 400%.

17. The system of any one of Claims 1-16, wherein the gas comprises air, nitrogen, nitrous oxide, carbon dioxide, or a mixture of any two or more thereof.

18. A foam composition comprising

about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC);

a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant;

about 50 wt.% to about 98 wt.% water; and

a gas;

wherein

a weight ratio of collagen to ORC is about 90: 10 to about 10:90; and the foam composition exhibits a foam capacity of about 20% to about 400%.

19. The foam composition of Claim 18, wherein the weight ratio of collagen to ORC is about 60:40 to about 40:60.

20. The foam composition of Claim 18 or Claim 19, wherein the rheology modifier comprises one or more of a polyol, a polyacrylate, xanthan gum, guar gum, locust bean gum, gelatin, agar, carrageenan, pectin, starch, and a starch derivative.

21. The foam composition of any one of Claims 18-20, wherein the rheology modifier comprises a gelling agent.

22. The foam composition of any one of Claims 18-21, wherein the rheology modifier comprises one or more gelling agents selected from the group consisting of alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, agar, carrageenan, locust bean gum, pectin, and gelatin.

23. The foam composition of any one of Claims 18-22, wherein the surfactant comprises one or more of an anionic surfactant, a cationic surfactant, a zwitterionic surfactant, and a non-ionic surfactant.

24. The foam composition of any one of Claims 18-23, wherein the rheology modifier comprises one or more polyols selected from the group consisting of a polyethylene glycol, propylene glycol, polyvinyl alcohol, glycerin, maltitol, erythritol, sorbitol, and mannitol.

25. The foam composition of any one of Claims 18-24, wherein the foam composition further

comprises about 0.001 wt.% to about 5 wt.% of an antimicrobial agent.

26. The foam composition of any one of Claims 18-25, wherein the antimicrobial agent comprises one or more of ionic silver, chlorhexidine, and iodine.

27. The foam composition of any one of Claims 18-26, wherein the foam composition further

comprises about 0.001 wt.% to about 5 wt.% of a wound healing promoter.

28. The foam composition of Claim 27, wherein the wound-healing promoter comprises one or more of zinc, zinc oxide, a zinc complex, vitamin E, and vitamin C.

29. The foam composition of any one of Claims 18-28, wherein the foam composition does not comprise a human-derived tissue.

30. The foam composition of any one of Claims 18-29, wherein the foam composition does not comprise an animal -derived tissue.

31. The foam composition of any one of Claims 18-30, wherein the foam composition exhibits a foam capacity of about 100% to about 400%.

32. The foam composition of any one of Claims 18-31, wherein the gas comprises air, nitrogen, nitrous oxide, carbon dioxide, or a mixture of any two or more thereof.

33. A method comprising foaming a mixture to a foam capacity of about 20% to about 400% to

generate the foam composition of any one of Claims 18-31; wherein the mixture comprises about 0.1 wt.% to about 45 wt.% collagen with a weight average molecular weight of about 5,000 to about 100,000;

about 0.1 wt.% to about 45 wt.% oxidized regenerated cellulose (ORC); a total amount of about 0.001 wt.% to about 50 wt.% of one or more of a rheology modifier and a surfactant; and

about 50 wt.% to about 98 wt.% water;

wherein a weight ratio of collagen to ORC is about 90: 10 to about 10:90.

34. The method of Claim 33, wherein the foaming comprises gas injection of the mixture.

35. The method of Claim 33 or Claim 34, wherein the mixture comprises gas and is pressurized to about 1.1 atm to about 10 atm prior to the foaming step.

36. The method of Claim 35, wherein the foaming comprises releasing the pressure from the mixture.

37. The method of any one of Claims 33-36, wherein the method comprises performing the foaming step within a wound in a patient.

38. The method of Claim 37, wherein the wound is a tunneling wound, a dermal wound, a diabetic wound, or a combination of any two or more thereof.

39. A method of treating a wound in a subject in need thereof, the method comprising contacting the wound with the foam composition of any one of Claims 18-31; wherein

the contacting comprises foaming a mixture to a foam capacity of about 20% to about 400%; and

the mixture comprises

about 50 wt.% to about 98 wt.% water; wherein a weight ratio of collagen to ORC is about 90: 10 to about 10:90.

40. The method of Claim 39, wherein the contacting comprises injecting the mixture within the

wound.

41. The method of Claim 39 and Claim 40, wherein the contacting comprises foaming the mixture to a foam capacity of about 100% to about 400%.

42. The method of any one of Claims 39-41, wherein the foaming comprises gas injection of the mixture.

43. The method of any one of Claims 39-42, wherein the mixture comprises gas and is pressurized to about 1.1 atm to about 10 atm prior to the foaming step.

44. The method of Claim 43, wherein the foaming comprises releasing the pressure from the mixture.

45. The method of any one of Claims 39-44, wherein the wound is a tunneling wound, a dermal wound, a diabetic wound, or a combination of any two or more thereof.