WO2020263900A1 - Devices for delivering a flowable hydrophilic tissue dressing material - Google Patents

Devices for delivering a flowable hydrophilic tissue dressing material Download PDF

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Publication number
WO2020263900A1
WO2020263900A1 PCT/US2020/039253 US2020039253W WO2020263900A1 WO 2020263900 A1 WO2020263900 A1 WO 2020263900A1 US 2020039253 W US2020039253 W US 2020039253W WO 2020263900 A1 WO2020263900 A1 WO 2020263900A1
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WO
WIPO (PCT)
Prior art keywords
combination
dressing material
group
moiety
flowable
Prior art date
Application number
PCT/US2020/039253
Other languages
French (fr)
Inventor
Christopher Brian Locke
Timothy Mark Robinson
Original Assignee
Kci Licensing, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kci Licensing, Inc. filed Critical Kci Licensing, Inc.
Publication of WO2020263900A1 publication Critical patent/WO2020263900A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/01Non-adhesive bandages or dressings
    • A61F13/01008Non-adhesive bandages or dressings characterised by the material
    • A61F13/01017Non-adhesive bandages or dressings characterised by the material synthetic, e.g. polymer based
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/05Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F17/00First-aid kits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials

Definitions

  • the invention set forth in the appended claims relates generally to treatment of tissue, including without limitation to devices for delivering a flowable hydrophilic tissue dressing material to a tissue site, such as a wound, kits, and methods for treating a tissue site.
  • dressings A wide variety of materials and devices, generally characterized as“dressings,” are generally known in the art for use in treating an injury, defect, or other disruption of tissue. Such disruptions of tissue may be the result of trauma, surgery, or disease, and may affect skin or other tissues. In general, dressings may control bleeding, absorb exudate, ease pain, assist in debriding tissue, protect tissue from infection, or otherwise promote healing and protect tissue from further damage.
  • 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.
  • a device for delivering a flowable hydrophilic tissue dressing material to a tissue site is described. More generally, a device including the flowable hydrophilic tissue dressing material, which includes a reacted polymer present in a carrier is provided.
  • the reacted polymer may be, for example, polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly- modified polyurethane, or a combination thereof.
  • the carrier may be, for example, a low boiling point liquid, water, a compressed gas, or a combination thereof.
  • the hydrophilicly- modified polyurethane can include a hydrophilic moiety, for example, a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety, a nitrogen-containing moiety, or a combination thereof.
  • the flowable hydrophilic tissue dressing material can be capable of solidifying to form a foam when applied to a tissue site.
  • the foam may be a closed cell foam or an open cell foam having at least 60 pores per inch (PPI) when applied to a wound.
  • kits including a device for delivering a flowable hydrophilic tissue dressing material and a cover.
  • the device may include the flowable hydrophilic tissue dressing material, which includes a reacted polymer present in a carrier.
  • the reacted polymer may be, for example, polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly-modified polyurethane, or a combination thereof.
  • the carrier may be, for example, a low boiling point liquid, water, a compressed gas, or a combination thereof.
  • the hydrophilicly-modified polyurethane can include a hydrophilic moiety, for example, a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium, a nitrogen-containing moiety, or a combination thereof.
  • other example embodiments may include a method for treating a tissue site.
  • the method can include applying a flowable hydrophilic tissue dressing material from a device to a tissue site, and solidifying the flowable hydrophilic tissue dressing material to form a foam adjacent to the tissue site.
  • the flowable hydrophilic tissue dressing material includes a reacted polymer present in a carrier.
  • the reacted polymer may be, for example, polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly- modified polyurethane, or a combination thereof.
  • the carrier may be, for example, a low boiling point liquid, water, a compressed gas, or a combination thereof.
  • the hydrophilicly- modified polyurethane can include a hydrophilic moiety, for example, a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety, a nitrogen-containing moiety, or a combination thereof.
  • the foam may be a closed cell foam or an open cell foam having at least 60 pores per inch (PPI) when applied to a wound.
  • Figure 1A is a cross-sectional view, illustrating details that may be associated with some embodiments of a device having a single container.
  • Figure IB is a cross-sectional view, illustrating details that may be associated with some alternative embodiments of a device having a canister.
  • Figure 1C is a cross-sectional view, illustrating details that may be associated with some alternative embodiments of a device an ultraviolet light source.
  • a flowable hydrophilic tissue dressing material for treating a tissue site, for example, for closing and/or filling an opening on a tissue site, such as a wound
  • the term“flowable” refers to an ability of a substance to be transported by gravity or under pressure from a storage vessel to a tissue site.
  • a“flowable” substance include, but are not limited to a liquid, a gel, a slurry, a suspension, an aerosol, and any combination thereof.
  • the term“hydrophilic” refers to a substance or a moiety, which has an affinity for water.
  • tissue site broadly refers to a wound or a defect located on or within tissue, including but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments.
  • a wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example.
  • tissue site may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue.
  • the devices described herein can deliver a flowable hydrophilic tissue dressing material, which can readily conform to the size and shape of the tissue site.
  • the devices, methods and kits described herein can form hydrophilic tissue dressings in various configurations.
  • a device for delivering a flowable hydrophilic tissue dressing material may include the flowable dressing material comprising a reacted polymer present in a carrier.
  • Figure 1A illustrates details that may be associated with some embodiments of a device 100.
  • the device 100 contains the flowable hydrophilic dressing material in a single container 105.
  • suitable reacted polymer include, but are not limited to polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly-modified polyurethane, and combinations and copolymers thereof.
  • the hydrophilicly-modified polyurethane can include any suitable hydrophilic moieties, such as, but not limited to a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety (e.g ., sodium ion, potassium ion, sodium salt, potassium salt), a nitrogen-containing moiety (e.g., an amine, an amide, an imine) and combination thereof.
  • peroxide and/or hydrogen peroxide may be included with the reacted polymer in the carrier.
  • the reacted polymer may include polymer segments with a low glass transition temperature, for example, less than or equal to about 25°C.
  • the reacted polymer may be dissolved or dispersed in a suitable carrier, such as, but not limited to a low boiling point liquid, water, a compressed gas, and combinations thereof.
  • a suitable carrier such as, but not limited to a low boiling point liquid, water, a compressed gas, and combinations thereof.
  • the reacted polymer and carrier may be in the form of a dispersion, solution or emulsion.
  • a low boiling point liquid include, but are not limited to a fluorocarbon, a chlorofluorocarbon, a hydrofluorocarbon (e.g., tetrafluoropropene, Solkane®) a hydrochlorofluorocarbon, and combinations thereof.
  • a compressed gas include but are not limited to compressed carbon dioxide, compressed nitrogen, a compressed alkane (e.g., methane, ethane, propane, and the like), and combinations thereof.
  • a canister 160 may be in fluid communication with a single container 105 of a device 101.
  • the canister 160 can contain a propellant, as further described below, for further enabling delivery of a flowable hydrophilic tissue dressing material from the device 101.
  • the propellant may expand to force the flowable hydrophilic tissue dressing material out of the device 103, for example, through holes in a spray nozzle as an aerosol.
  • canister 160 can be present in any of the device embodiments described herein. Additionally, the canister 160 may be removable or irremovable.
  • an ultraviolet (UV) light source 165 may be included with the device 102, for example, for further solidifying a flowable hydrophilic tissue dressing material at a tissue site. While Figure 1C illustrates a UV light source 165 as integral to the single container 105, it is contemplated herein that the UV light source 165 may be removable from the single container 105 and/or may be separate from the single container 105. Although not shown, it is contemplated herein that UV light source 165 can be present in any of the device embodiments described herein.
  • a delivery tube 170 optionally may be present for delivering a flowable hydrophilic tissue dressing material from the devices 100, 101, 102.
  • a delivery means 185 may be in fluid communication with the delivery tube 170 for delivering the flowable dressing material to a tissue site.
  • suitable delivery means 185 include, but are not limited to a nozzle, such as a spray nozzle, or a manifold delivery tube.
  • the flowable dressing material may be transferred and/or mixed in a separate vessel (e.g ., measuring cup) from which it can be poured onto a tissue site.
  • a delivery tube 170 may be absent and any of the devices described herein may include a removable cap, so that a flowable hydrophilic tissue dressing material can be poured from the devices onto a tissue site.
  • a mixer 190 for mixing the flowable hydrophilic tissue dressing material may be include in the device, for example, as illustrated in Figure 1A in device 100.
  • a suitable mixer 190 include but are not limited to a ball (e.g., metal, glass, or plastic ball), a mechanical reciprocating plunger, magnetically coupled impeller or beads, for example, where an external magnetic source rotates the impellor or agitates the beads.
  • the mixer 190 can be present in any of the device embodiments described herein.
  • the flowable hydrophilic tissue dressing material is capable of solidifying to form a foam when applied to a tissue site.
  • the foam formed may be an open cell foam or a closed cell foam.
  • the open cell foam may have at least 60 pores per inch (PPI).
  • PPI pores per inch
  • the foam may have a higher molecular weight (M n ), for example, greater than or equal to about 100,000, greater than or equal to about 500,000 or about 1,000,000; or from about 100,000 to about 1,000,000, about 250,000 to about 1,000,000 or about 500,000 to about
  • the foam may have a moisture vapor transmission rate (MVRT) of about 250 g/m 2 /24 hours to about 1500 g/m 2 /24 hours, or about 500 g/m 2 /24 hours to about 1500 g/m 2 /24 hours, or about 1000 g/m 2 /24 hours to about 1500 g/m 2 /24 hours.
  • MVRT moisture vapor transmission rate
  • the devices described herein may be made of any suitable material, such as, but not limited to metal, plastic, or a combination thereof.
  • Suitable metals include, but are not limited to aluminum and coated steels.
  • Suitable plastics include, but are not limited to polycarbonates, polyesters, and polyolefins.
  • an interior of the devices described herein is sterile and the contents of the device may be sterile. Sterilization can be achieved by any known methods in the art, for example, via gamma sterilization or electron beam (e-beam) sterilization.
  • the devices described herein may include a window, for example, a plastic window, to permit transmission of the e- beam.
  • the devices described herein can include one or more additional agents for incorporation into a flowable hydrophilic tissue dressing material.
  • a cell opener can be included in the devices described herein to promote opening or rupturing of cell walls and to enhance an open cell structure as the polymer foam is produced.
  • suitable cell opener include, but are not limited to a silicone, a polyether siloxane, a mineral ( e.g ., clays, silicas, calcium carbonate and the like), and combinations thereof.
  • the devices described herein can further include a foaming agent, a propellant, or a combination thereof to assist with foam formation and delivery.
  • a foaming agent includes any suitable surfactants and blowing agents as known in the art for producing a flowable hydrophilic tissue dressing material, e.g., a polymer foam.
  • suitable foaming agents include, but are not limited to, a low boiling point liquid, water, a compressed gas, hydrocarbons (e.g. pentane, isopentane, cyclopentane), liquid carbon dioxide, and combinations thereof.
  • Examples of a low boiling point liquid include, but are not limited to a fluorocarbon, a chlorofluorocarbon, a hydrofluorocarbon (e.g., tetrafluoropropene, Solkane®) a hydrochlorofluorocarbon, and combinations thereof.
  • Examples of a compressed gas include but are not limited to compressed carbon dioxide, compressed nitrogen, a compressed alkane (e.g., methane, ethane, propane, and the like), and combinations thereof.
  • Examples of a suitable propellant include, but are not limited to low boiling point liquids as described herein. The propellant may be present within the devices described herein, for example, in the single container 105.
  • the propellant may be present in a separate canister 160 in fluid communication with the devices described herein.
  • the propellant may also aid in mixing of the flowable hydrophilic tissue dressing material.
  • the devices described herein and/or the flowable hydrophilic tissue dressing material can further include a softener, such as water soluble particles, to encourage a certain degree of porosity at the tissue site interface, which upon contact with water present in the wound can soften and/or dissolve to leave pores or fissures in foam.
  • a softener such as water soluble particles
  • suitable water soluble particles include, but are not limited to a salt, a water soluble polymer, and combinations thereof.
  • a salt include, but are not limited to sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and combinations thereof.
  • water soluble polymers include, but are not limited to polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and combinations thereof.
  • the devices described herein and/or the flowable hydrophilic tissue dressing material can further include an antimicrobial agent.
  • suitable antimicrobial agents include, but are not limited to organic acids such as carboxylic acids, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and combinations thereof.
  • exemplary carboxylic acids include, but are not limited to ascorbic acid (e.g., (R)-3,4-dihydroxy-5-((S)- l,2-dihydroxyethyl)furan-2(5H)-one or Vitamin C), formic acid, gluconic acid, lactic acid, oxalic acid, tartaric acid, peroxy-pyruvic acid, and combinations thereof.
  • carboxylic acids include, but are not limited to citric acid and acetic acid (i.e., ethanoic acid).
  • the metal e.g., silver
  • the metal may be present in metallic form, in ionic form (e.g., a silver salt), or both.
  • the devices described herein and/or the flowable hydrophilic tissue dressing material can further include a polysaccharide, such as chitosan and/or an anionic polysaccharide.
  • the anionic polysaccharide may be substantially insoluble in water at pH 7. Additionally or alternatively, the anionic polysaccharide may have a molecular weight greater than about 20,000, more preferably greater than about 50,000.
  • the anionic polysaccharide may be in the form of a film, or fibers having a length greater than 1 mm.
  • Suitable anionic polysaccharides include, but are not limited to, polycarboxylates, alginates, hyaluronates, pectins, carrageenans, xanthan gums, sulfated dextrans, cellulose derivatives, such as carboxymethyl celluloses, and oxidized celluloses.
  • oxidized cellulose refers to any material produced by the oxidation of cellulose, for example with dinitrogen tetroxide. Such oxidation converts primary alcohol groups on the saccharide residues to carboxylic acid groups, forming uronic acid residues within the cellulose chain.
  • oxidized cellulose may be oxidized regenerated cellulose (ORC), which may be prepared by oxidation of a regenerated cellulose, such as rayon. It has been known that ORC has haemostatic properties. ORC has been available as a haemostatic fabric called SURGICEL ® (Johnson & Johnson Medical, Inc.) since 1950. This product may be produced by the oxidation of a knitted rayon material.
  • ORC oxidized regenerated cellulose
  • the devices described herein and/or the flowable hydrophilic tissue dressing material can further include one or more super absorbent polymers, for example in particle form.
  • suitable super absorbent polymers include, but are not limited to polyacrylic acid, a salt of polyacrylic acid (e.g ⁇ sodium polyacrylate (Luquasorb® 1160, Luquasorb® 1161; BASF)), polyacrylamide, cellulosic polymer, 2- acrylamido-2-methylpropanesulfonic acid (AMPS), polyethylene oxide (PEO), and a combination thereof.
  • the devices described herein and/or the flowable hydrophilic tissue dressing material can further include an alcohol, a colorant (e.g ., a pigment, a dye), a release agent (e.g., wax, fluorocarbon), and a combination thereof.
  • a colorant e.g ., a pigment, a dye
  • a release agent e.g., wax, fluorocarbon
  • an alcohol can be included as a further solvent and/or suspending agent along with the reacted polymer.
  • a suitable alcohol include, but are not limited to ethanol, isopropyl alcohol, and a combination thereof.
  • the devices described herein and/or the flowable hydrophilic tissue dressing material can further include a photoinitiator that is capable of undergoing photopolymerization or radiation curing, i.e., producing a free radical when exposed to radiation, e.g., UV light, which can react, for example, with the first reactant and/or the second reactant, to initiate polymer chain growth.
  • a photoinitiator that is capable of undergoing photopolymerization or radiation curing, i.e., producing a free radical when exposed to radiation, e.g., UV light, which can react, for example, with the first reactant and/or the second reactant, to initiate polymer chain growth.
  • Examples of a suitable photoinitiator include, but are not limited to, 2,2-dimethoxy-l,2,-diphenylethan-l-one, 1 -hydroxy- cyclohexyl-phenyl-ketone (IRGACURE® 184); l-[4-(2-hydroxyethoxy)-phenyl]-2-hydroxy- 2-methyl-l -propane- 1 -one (IRGACURE® 2959); and 2-benzyl-2-(dimethylamino)-l-[4- (4- morpholinyl) phenyl] -1-butanone (IRGACURE® 369).
  • Kits including the devices described herein are also provided.
  • the kits may further include a cover.
  • the cover may provide a bacterial barrier and protection from physical trauma.
  • the cover may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment.
  • the cover may be, for example, an elastomeric film or membrane.
  • the cover may have a high moisture-vapor transmission rate in some applications.
  • the MVTR may be at least 300 g/m 2 per twenty-four hours in some embodiments.
  • the cover may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid.
  • a polymer drape such as a polyurethane film
  • Such drapes typically have a thickness in the range of about 25 microns to about 50 microns.
  • the permeability generally should be low enough that a desired negative pressure may be maintained.
  • Methods for treating a tissue site with a device as described herein are also provided.
  • the method can include applying a flowable hydrophilic tissue dressing material from a device as described herein to a tissue site and solidifying the flowable hydrophilic tissue dressing material to form a foam as described herein, for example, a closed cell foam or an open cell foam having at least 60 pores per inch (PPI) adjacent to the tissue site.
  • the flowable hydrophilic tissue dressing material may be mixed prior to application to a tissue site. Mixing can be achieved by a user, for example, by agitating the device. Additionally or alternatively, a mixer as described herein, e.g., mixer 190, can be present in the device to aid in mixing.
  • the flowable hydrophilic tissue dressing material may be poured, injected, or sprayed onto or into a tissue site.
  • the tissue site is an internal site and the flowable hydrophilic tissue dressing material may be delivered percutaneously.
  • Solidifying the flowable hydrophilic tissue dressing material can be achieved by any known means in the art, for example, via cooling, reacting, heating, curing, cross- linking, exposure to ultraviolet light, and combinations thereof.
  • the flowable hydrophilic tissue dressing material is allowed to react completely, e.g., foaming has stopped and the majority of heat is released, before applying the flowable hydrophilic tissue dressing material to a tissue site.
  • the flowable hydrophilic tissue dressing material is applied to a tissue site while still reacting, e.g., foaming. In such instances, the cooler temperature of the tissue site can slow and/or stop the foaming.
  • a device contains the flowable hydrophilic tissue dressing material, which includes the reacted polymer as described herein present in a carrier as described herein.
  • the devices, kits, and methods described herein may provide significant advantages.
  • the devices described herein can provide a tissue dressing material that can be readily applied to wounds of varying sizes without needing timely customization.
  • the hydrophilic nature of the tissue dressing material can allow for enhanced breathability, absorbency and/or wicking of the tissue dressing material applied to the tissue site.
  • the nature of the flowable hydrophilic tissue dressing material can also allow for better adhesion between the tissue dressing material and skin of a tissue site.
  • the devices for delivery of a flowable hydrophilic tissue dressing material can eliminate the need for additional traditional dressing material components, such as support and release layers.
  • the devices are portable and can be used in many environments and settings to produce tissue dressings in various configurations.

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Abstract

Devices for delivering a flowable hydrophilic tissue dressing material for treating a tissue site are described. The devices can also include a flowable hydrophilic tissue dressing material including a reacted polymer, for example, polyvinylpyrrolidone (PVP), present in a carrier, for example, water. Kits and methods including and/or using the devices are also described.

Description

DEVICES FOR DELIVERING A FLOWABLE HYDROPHILIC TISSUE DRESSING
MATERIAL
RELATED APPLICATION
[0001] The present application claims priority to U.S. Provisional Patent Application No. 62/866,354, entitled“DEVICES FOR DELIVERING A FLOWABLE HYDROPHILIC TISSUE DRESSING MATERIAL AND METHODS OF USE,” filed June 25, 2019, which is incorporated herein by reference for all purposes.
TECHNICAL FIELD
[0002] The invention set forth in the appended claims relates generally to treatment of tissue, including without limitation to devices for delivering a flowable hydrophilic tissue dressing material to a tissue site, such as a wound, kits, and methods for treating a tissue site.
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, defect, or other disruption of tissue. Such disruptions of tissue may be the result of trauma, surgery, or disease, and may affect skin or other tissues. In general, dressings may control bleeding, absorb exudate, ease pain, assist in debriding tissue, protect tissue from infection, or otherwise promote healing and protect tissue 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.
SUMMARY
[0005] New and useful devices, methods, and kits for treating a tissue site are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.
[0006] For example, in some embodiments, a device for delivering a flowable hydrophilic tissue dressing material to a tissue site is described. More generally, a device including the flowable hydrophilic tissue dressing material, which includes a reacted polymer present in a carrier is provided. The reacted polymer may be, for example, polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly- modified polyurethane, or a combination thereof. The carrier may be, for example, a low boiling point liquid, water, a compressed gas, or a combination thereof. The hydrophilicly- modified polyurethane can include a hydrophilic moiety, for example, a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety, a nitrogen-containing moiety, or a combination thereof.
[0007] The flowable hydrophilic tissue dressing material can be capable of solidifying to form a foam when applied to a tissue site. The foam may be a closed cell foam or an open cell foam having at least 60 pores per inch (PPI) when applied to a wound.
[0008] Alternatively, other example embodiments may include a kit including a device for delivering a flowable hydrophilic tissue dressing material and a cover. The device may include the flowable hydrophilic tissue dressing material, which includes a reacted polymer present in a carrier. The reacted polymer may be, for example, polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly-modified polyurethane, or a combination thereof. The carrier may be, for example, a low boiling point liquid, water, a compressed gas, or a combination thereof. The hydrophilicly-modified polyurethane can include a hydrophilic moiety, for example, a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium, a nitrogen-containing moiety, or a combination thereof.
[0009] Alternatively, other example embodiments may include a method for treating a tissue site. The method can include applying a flowable hydrophilic tissue dressing material from a device to a tissue site, and solidifying the flowable hydrophilic tissue dressing material to form a foam adjacent to the tissue site. The flowable hydrophilic tissue dressing material includes a reacted polymer present in a carrier. The reacted polymer may be, for example, polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly- modified polyurethane, or a combination thereof. The carrier may be, for example, a low boiling point liquid, water, a compressed gas, or a combination thereof. The hydrophilicly- modified polyurethane can include a hydrophilic moiety, for example, a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety, a nitrogen-containing moiety, or a combination thereof. The foam may be a closed cell foam or an open cell foam having at least 60 pores per inch (PPI) when applied to a wound.
[0010] Objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Figure 1A is a cross-sectional view, illustrating details that may be associated with some embodiments of a device having a single container.
[0012] Figure IB is a cross-sectional view, illustrating details that may be associated with some alternative embodiments of a device having a canister.
[0013] Figure 1C is a cross-sectional view, illustrating details that may be associated with some alternative embodiments of a device an ultraviolet light source.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0014] The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.
[0015] The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.
I. Devices for Delivering a Flowable Hydrophilic Tissue Dressing Material
[0016] Devices for delivering a flowable hydrophilic tissue dressing material for treating a tissue site, for example, for closing and/or filling an opening on a tissue site, such as a wound, are described herein. As used herein, the term“flowable” refers to an ability of a substance to be transported by gravity or under pressure from a storage vessel to a tissue site. Examples of a“flowable” substance include, but are not limited to a liquid, a gel, a slurry, a suspension, an aerosol, and any combination thereof. As used herein, the term“hydrophilic” refers to a substance or a moiety, which has an affinity for water. That is, a hydrophilic substance or moiety tends to substantially attract water, is substantially soluble in water, and/or is substantially miscible with or wetted by water. As used herein, the term“tissue site” broadly refers to a wound or a defect located on or within tissue, including but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term“tissue site” may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. The devices described herein can deliver a flowable hydrophilic tissue dressing material, which can readily conform to the size and shape of the tissue site. Thus, the devices, methods and kits described herein can form hydrophilic tissue dressings in various configurations.
[0017] A device for delivering a flowable hydrophilic tissue dressing material may include the flowable dressing material comprising a reacted polymer present in a carrier. Figure 1A illustrates details that may be associated with some embodiments of a device 100. The device 100 contains the flowable hydrophilic dressing material in a single container 105. Examples of a suitable reacted polymer include, but are not limited to polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly-modified polyurethane, and combinations and copolymers thereof. The hydrophilicly-modified polyurethane can include any suitable hydrophilic moieties, such as, but not limited to a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety ( e.g ., sodium ion, potassium ion, sodium salt, potassium salt), a nitrogen-containing moiety (e.g., an amine, an amide, an imine) and combination thereof. In some embodiments, peroxide and/or hydrogen peroxide may be included with the reacted polymer in the carrier. Additionally or alternatively, the reacted polymer may include polymer segments with a low glass transition temperature, for example, less than or equal to about 25°C.
[0018] The reacted polymer may be dissolved or dispersed in a suitable carrier, such as, but not limited to a low boiling point liquid, water, a compressed gas, and combinations thereof. The reacted polymer and carrier may be in the form of a dispersion, solution or emulsion. Examples of a low boiling point liquid include, but are not limited to a fluorocarbon, a chlorofluorocarbon, a hydrofluorocarbon (e.g., tetrafluoropropene, Solkane®) a hydrochlorofluorocarbon, and combinations thereof. Examples of a compressed gas include but are not limited to compressed carbon dioxide, compressed nitrogen, a compressed alkane (e.g., methane, ethane, propane, and the like), and combinations thereof.
[0019] Optionally, as illustrated in Figure IB, a canister 160 may be in fluid communication with a single container 105 of a device 101. The canister 160 can contain a propellant, as further described below, for further enabling delivery of a flowable hydrophilic tissue dressing material from the device 101. For example, the propellant may expand to force the flowable hydrophilic tissue dressing material out of the device 103, for example, through holes in a spray nozzle as an aerosol. Although not shown, it is contemplated herein that canister 160 can be present in any of the device embodiments described herein. Additionally, the canister 160 may be removable or irremovable. Optionally, as illustrated in Figure 1C, an ultraviolet (UV) light source 165 may be included with the device 102, for example, for further solidifying a flowable hydrophilic tissue dressing material at a tissue site. While Figure 1C illustrates a UV light source 165 as integral to the single container 105, it is contemplated herein that the UV light source 165 may be removable from the single container 105 and/or may be separate from the single container 105. Although not shown, it is contemplated herein that UV light source 165 can be present in any of the device embodiments described herein.
[0020] As illustrated in Figures 1A-1C, a delivery tube 170 optionally may be present for delivering a flowable hydrophilic tissue dressing material from the devices 100, 101, 102. A delivery means 185 may be in fluid communication with the delivery tube 170 for delivering the flowable dressing material to a tissue site. Examples of suitable delivery means 185 include, but are not limited to a nozzle, such as a spray nozzle, or a manifold delivery tube. In some embodiments, the flowable dressing material may be transferred and/or mixed in a separate vessel ( e.g ., measuring cup) from which it can be poured onto a tissue site. It is also contemplated herein that a delivery tube 170 may be absent and any of the devices described herein may include a removable cap, so that a flowable hydrophilic tissue dressing material can be poured from the devices onto a tissue site. Optionally, a mixer 190 for mixing the flowable hydrophilic tissue dressing material may be include in the device, for example, as illustrated in Figure 1A in device 100. Examples of a suitable mixer 190 include but are not limited to a ball (e.g., metal, glass, or plastic ball), a mechanical reciprocating plunger, magnetically coupled impeller or beads, for example, where an external magnetic source rotates the impellor or agitates the beads. Although not shown, it is contemplated herein that the mixer 190 can be present in any of the device embodiments described herein.
[0021] The flowable hydrophilic tissue dressing material is capable of solidifying to form a foam when applied to a tissue site. The foam formed may be an open cell foam or a closed cell foam. The open cell foam may have at least 60 pores per inch (PPI). In any embodiment, the foam may have a higher molecular weight (Mn), for example, greater than or equal to about 100,000, greater than or equal to about 500,000 or about 1,000,000; or from about 100,000 to about 1,000,000, about 250,000 to about 1,000,000 or about 500,000 to about
1,000,000. Additionally or alternatively, the foam may have a moisture vapor transmission rate (MVRT) of about 250 g/m2/24 hours to about 1500 g/m2/24 hours, or about 500 g/m2/24 hours to about 1500 g/m2/24 hours, or about 1000 g/m2/24 hours to about 1500 g/m2/24 hours.
[0022] In any embodiment, the devices described herein may be made of any suitable material, such as, but not limited to metal, plastic, or a combination thereof. Suitable metals include, but are not limited to aluminum and coated steels. Suitable plastics include, but are not limited to polycarbonates, polyesters, and polyolefins. In any embodiment, an interior of the devices described herein is sterile and the contents of the device may be sterile. Sterilization can be achieved by any known methods in the art, for example, via gamma sterilization or electron beam (e-beam) sterilization. In the case of e-beam sterilization, the devices described herein may include a window, for example, a plastic window, to permit transmission of the e- beam.
[0023] The devices described herein can include one or more additional agents for incorporation into a flowable hydrophilic tissue dressing material. In any embodiment, a cell opener can be included in the devices described herein to promote opening or rupturing of cell walls and to enhance an open cell structure as the polymer foam is produced. Examples of a suitable cell opener include, but are not limited to a silicone, a polyether siloxane, a mineral ( e.g ., clays, silicas, calcium carbonate and the like), and combinations thereof.
[0024] Additionally or alternatively, the devices described herein can further include a foaming agent, a propellant, or a combination thereof to assist with foam formation and delivery. As used herein, a foaming agent includes any suitable surfactants and blowing agents as known in the art for producing a flowable hydrophilic tissue dressing material, e.g., a polymer foam. Examples of suitable foaming agents include, but are not limited to, a low boiling point liquid, water, a compressed gas, hydrocarbons (e.g. pentane, isopentane, cyclopentane), liquid carbon dioxide, and combinations thereof. Examples of a low boiling point liquid include, but are not limited to a fluorocarbon, a chlorofluorocarbon, a hydrofluorocarbon (e.g., tetrafluoropropene, Solkane®) a hydrochlorofluorocarbon, and combinations thereof. Examples of a compressed gas include but are not limited to compressed carbon dioxide, compressed nitrogen, a compressed alkane (e.g., methane, ethane, propane, and the like), and combinations thereof. Examples of a suitable propellant include, but are not limited to low boiling point liquids as described herein. The propellant may be present within the devices described herein, for example, in the single container 105. Alternatively, with reference to Figure IB, the propellant may be present in a separate canister 160 in fluid communication with the devices described herein. In addition to aiding in delivery of a flowable hydrophilic tissue dressing material, the propellant may also aid in mixing of the flowable hydrophilic tissue dressing material.
[0025] Additionally or alternatively, the devices described herein and/or the flowable hydrophilic tissue dressing material can further include a softener, such as water soluble particles, to encourage a certain degree of porosity at the tissue site interface, which upon contact with water present in the wound can soften and/or dissolve to leave pores or fissures in foam. Examples of suitable water soluble particles include, but are not limited to a salt, a water soluble polymer, and combinations thereof. Examples of a salt include, but are not limited to sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and combinations thereof. Examples of water soluble polymers include, but are not limited to polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and combinations thereof.
[0026] Additionally or alternatively, the devices described herein and/or the flowable hydrophilic tissue dressing material can further include an antimicrobial agent. Examples of suitable antimicrobial agents include, but are not limited to organic acids such as carboxylic acids, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and combinations thereof. Exemplary carboxylic acids include, but are not limited to ascorbic acid (e.g., (R)-3,4-dihydroxy-5-((S)- l,2-dihydroxyethyl)furan-2(5H)-one or Vitamin C), formic acid, gluconic acid, lactic acid, oxalic acid, tartaric acid, peroxy-pyruvic acid, and combinations thereof. Examples of carboxylic acids include, but are not limited to citric acid and acetic acid (i.e., ethanoic acid). The metal (e.g., silver) may be present in metallic form, in ionic form (e.g., a silver salt), or both.
[0027] Additionally or alternatively, the devices described herein and/or the flowable hydrophilic tissue dressing material can further include a polysaccharide, such as chitosan and/or an anionic polysaccharide. The anionic polysaccharide may be substantially insoluble in water at pH 7. Additionally or alternatively, the anionic polysaccharide may have a molecular weight greater than about 20,000, more preferably greater than about 50,000. The anionic polysaccharide may be in the form of a film, or fibers having a length greater than 1 mm. Suitable anionic polysaccharides include, but are not limited to, polycarboxylates, alginates, hyaluronates, pectins, carrageenans, xanthan gums, sulfated dextrans, cellulose derivatives, such as carboxymethyl celluloses, and oxidized celluloses. The term“oxidized cellulose” refers to any material produced by the oxidation of cellulose, for example with dinitrogen tetroxide. Such oxidation converts primary alcohol groups on the saccharide residues to carboxylic acid groups, forming uronic acid residues within the cellulose chain. The oxidation generally does not proceed with complete selectivity, and as a result hydroxyl groups on carbons 2 and 3 are occasionally converted to the keto form. These keto units 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. In some embodiments, oxidized cellulose may be oxidized regenerated cellulose (ORC), which may be prepared by oxidation of a regenerated cellulose, such as rayon. It has been known that ORC has haemostatic properties. ORC has been available as a haemostatic fabric called SURGICEL® (Johnson & Johnson Medical, Inc.) since 1950. This product may be produced by the oxidation of a knitted rayon material.
[0028] Additionally or alternatively, the devices described herein and/or the flowable hydrophilic tissue dressing material can further include one or more super absorbent polymers, for example in particle form. Examples of suitable super absorbent polymers include, but are not limited to polyacrylic acid, a salt of polyacrylic acid (e.g^ sodium polyacrylate (Luquasorb® 1160, Luquasorb® 1161; BASF)), polyacrylamide, cellulosic polymer, 2- acrylamido-2-methylpropanesulfonic acid (AMPS), polyethylene oxide (PEO), and a combination thereof.
[0029] Additionally or alternatively, the devices described herein and/or the flowable hydrophilic tissue dressing material can further include an alcohol, a colorant ( e.g ., a pigment, a dye), a release agent (e.g., wax, fluorocarbon), and a combination thereof. For example, an alcohol can be included as a further solvent and/or suspending agent along with the reacted polymer. Examples of a suitable alcohol include, but are not limited to ethanol, isopropyl alcohol, and a combination thereof.
[0030] Additionally or alternatively, the devices described herein and/or the flowable hydrophilic tissue dressing material can further include a photoinitiator that is capable of undergoing photopolymerization or radiation curing, i.e., producing a free radical when exposed to radiation, e.g., UV light, which can react, for example, with the first reactant and/or the second reactant, to initiate polymer chain growth. Examples of a suitable photoinitiator include, but are not limited to, 2,2-dimethoxy-l,2,-diphenylethan-l-one, 1 -hydroxy- cyclohexyl-phenyl-ketone (IRGACURE® 184); l-[4-(2-hydroxyethoxy)-phenyl]-2-hydroxy- 2-methyl-l -propane- 1 -one (IRGACURE® 2959); and 2-benzyl-2-(dimethylamino)-l-[4- (4- morpholinyl) phenyl] -1-butanone (IRGACURE® 369).
II. Kits for Delivering a Flowable hydrophilic tissue Dressing Material
[0031] Kits including the devices described herein are also provided. The kits may further include a cover. In some embodiments, the cover may provide a bacterial barrier and protection from physical trauma. The cover may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The cover may be, for example, an elastomeric film or membrane. The cover may have a high moisture-vapor transmission rate in some applications. For example, the MVTR may be at least 300 g/m2 per twenty-four hours in some embodiments. In some example embodiments, the cover may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. Such drapes typically have a thickness in the range of about 25 microns to about 50 microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained.
III. Methods for Treating a Tissue Site
[0032] Methods for treating a tissue site with a device as described herein are also provided. The method can include applying a flowable hydrophilic tissue dressing material from a device as described herein to a tissue site and solidifying the flowable hydrophilic tissue dressing material to form a foam as described herein, for example, a closed cell foam or an open cell foam having at least 60 pores per inch (PPI) adjacent to the tissue site. In any embodiment, the flowable hydrophilic tissue dressing material may be mixed prior to application to a tissue site. Mixing can be achieved by a user, for example, by agitating the device. Additionally or alternatively, a mixer as described herein, e.g., mixer 190, can be present in the device to aid in mixing. In any embodiment, the flowable hydrophilic tissue dressing material may be poured, injected, or sprayed onto or into a tissue site. In some embodiments, the tissue site is an internal site and the flowable hydrophilic tissue dressing material may be delivered percutaneously.
[0033] Solidifying the flowable hydrophilic tissue dressing material can be achieved by any known means in the art, for example, via cooling, reacting, heating, curing, cross- linking, exposure to ultraviolet light, and combinations thereof. In some embodiments, the flowable hydrophilic tissue dressing material is allowed to react completely, e.g., foaming has stopped and the majority of heat is released, before applying the flowable hydrophilic tissue dressing material to a tissue site. In other embodiments, the flowable hydrophilic tissue dressing material is applied to a tissue site while still reacting, e.g., foaming. In such instances, the cooler temperature of the tissue site can slow and/or stop the foaming.
[0034] In any embodiment, a device contains the flowable hydrophilic tissue dressing material, which includes the reacted polymer as described herein present in a carrier as described herein. [0035] The devices, kits, and methods described herein may provide significant advantages. For example, the devices described herein can provide a tissue dressing material that can be readily applied to wounds of varying sizes without needing timely customization. Advantageously, the hydrophilic nature of the tissue dressing material can allow for enhanced breathability, absorbency and/or wicking of the tissue dressing material applied to the tissue site. The nature of the flowable hydrophilic tissue dressing material can also allow for better adhesion between the tissue dressing material and skin of a tissue site. Additionally, the devices for delivery of a flowable hydrophilic tissue dressing material can eliminate the need for additional traditional dressing material components, such as support and release layers. Furthermore, the devices are portable and can be used in many environments and settings to produce tissue dressings in various configurations.
[0036] While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as“or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context. Components may be also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations the delivery tube 170, the delivery means 185, or both may be eliminated or separated from other components for manufacture or sale.
[0037] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.

Claims

CLAIMS What is claimed is:
1. A device for delivering a flowable hydrophilic tissue dressing material, wherein the
device comprises:
the flowable hydrophilic tissue dressing material comprising a reacted polymer present in a carrier,
wherein the reacted polymer is selected from the group consisting of
polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly-modified polyurethane, and a combination thereof, and
wherein the carrier is a low boiling point liquid, water, a compressed gas, or a combination thereof.
2. The device of claim 1, wherein the hydrophilicly-modified polyurethane comprises a hydrophilic moiety selected from the group consisting a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety, a nitrogen-containing moiety, and a combination thereof.
3. The device of claim 1 or claim 2, wherein the low boiling point liquid is a fluorocarbon, a chlorofluorocarbon, or a combination thereof.
4. The device of any one of the previous claims, wherein the compressed gas comprises carbon dioxide, nitrogen, an alkane, or a combination thereof.
5. The device of any one of the previous claims, further comprising one or more of:
(i) a cell opener;
(ii) water soluble particles;
(iii) an alcohol;
(iv) a propellant;
(v) an antimicrobial agent;
(vi) collagen;
(vii) oxidized regenerated cellulose (ORC);
(viii) chitosan; and
(ix) a super absorbent polymer.
6. The device of claim 5, wherein the cell opener is selected from the group consisting of a silicone, a polyether siloxane, a mineral, and a combination thereof.
7. The device of claim 5 or claim 6, wherein the water soluble particles comprises a salt, a water soluble polymer, or a combination thereof.
8. The device of claim 7, wherein the salt is selected from the group consisting of sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and a combination thereof.
9. The device of claim 7 or claim 8, wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and a
combination thereof.
10. The device of any one of claims 5 to 9, wherein the antimicrobial agent is selected from the group consisting of a carboxylic acid, silver, gold, zinc, copper, polyhexamethylene biguanide (PHMB), iodine and a combination thereof.
11. The device of any one of claims 5 to 10, wherein super absorbent polymer is selected from the group consisting of polyacrylic acid, a salt of polyacrylic acid, polyacrylamide, cellulosic polymer, 2-acrylamido-2-methylpropanesulfonic acid (AMPS), polyethylene oxide (PEO), and a combination thereof
12. The device of any one of the previous claims, further comprising one or more of:
(i) a photoinitiator;
(ii) an ultraviolet light source for solidifying the flowable hydrophilic tissue dressing material;
(iii) a mixer for mixing the flowable hydrophilic tissue dressing material; and
(iv) a delivery tube for delivering the flowable hydrophilic tissue dressing material.
13. The device of any one of the previous claims, wherein the flowable hydrophilic tissue dressing material is capable of solidifying to form a foam when applied to a tissue site, wherein the foam is selected from the group consisting of a closed cell foam and an open cell foam having at least 60 pores per inch (PPI).
14. The device of claim 13, wherein the foam has a moisture vapor transmission rate of about 250 g/m2/24 hours to about 1500 g/m2/24 hours.
15. The device of claim 13 of claim 14, wherein the foam has a molecular weight of greater than or equal to about 100,000.
16. The device of any one of the previous claims, wherein an interior of the device is sterile and/or the device is formed from metal, plastic, or a combination thereof.
17. A kit comprising the device of any one of the previous claims and a cover.
18. A method for treating a tissue site, the method comprising:
applying a flowable hydrophilic tissue dressing material from a device to a tissue site, wherein the flowable hydrophilic tissue dressing material comprises a reacted polymer present in a carrier, wherein the reacted polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polyethylene oxide (PEO), hydrophilicly-modified polyurethane, and a combination thereof, and wherein the carrier is a low boiling point liquid, water, a compressed gas, or a combination thereof; and solidifying the flowable hydrophilic wound filler material to form a foam adjacent to the tissue site, wherein the foam is selected from the group consisting of a closed cell foam and an open cell foam having at least 60 pores per inch (PPI).
19. The method of claim 18, wherein the hydrophilicly-modified polyurethane comprises a hydrophilic moiety selected from the group consisting a hydroxyl moiety, a carboxyl moiety, an ester moiety, a quaternary ammonium ion moiety, a metal ion moiety, a nitrogen-containing moiety, and a combination thereof.
20. The method of claim 18 or 19, wherein the low boiling point liquid is a fluorocarbon, a chlorofluorocarbon, or a combination thereof.
21. The method of any one of claims 18 to 20, wherein the compressed gas comprises carbon dioxide, nitrogen, an alkane, or a combination thereof.
22. The method of any one of claims 18 to 21, wherein the device further comprising one or more of:
(i) a cell opener;
(ii) water soluble particles;
(iii) an alcohol;
(iv) a propellant;
(v) an antimicrobial agent;
(vi) collagen;
(vii) oxidized regenerated cellulose (ORC);
(viii) chitosan; and
(lxj a super absorbent polymer.
23. The method of claim 22, wherein the cell opener is selected from the group consisting of a silicone, a polyether siloxane, a mineral, and a combination thereof.
24. The method of clai m 22 or claim 23, wherein the water soluble particles comprises a salt, a water soluble polymer, or a combination thereof.
25. The method of claim 24, wherein the salt is selected from the group consisting of sodium chloride, magnesium chloride, calcium chloride, sodium carbonate, potassium carbonate, and a combination thereof.
26. The method of claim 24 or claim 25, wherein the water soluble polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), a polyvinyl alcohol, polycihylcnc oxide (PEO), carboxy modified polyurethane, hydroxy modified polyurethane, and a combination thereof.
27. The method of any one of claims 22 to 26, wherein the antimicrobial agent is selected from the group consisting of a carboxylic acid, silver, gold, zinc, copper,
polyhexamethylene biguanide (PIIMB), iodine and a combination thereof.
28. The method of any one of claims 22 to 27, wherein super absorbent polymer is selected from the group consisting of polyacrylic acid, a salt of polyacrylic acid, polyacrylamide, cellulosic polymer, 2-acrylamido-2-methylpropanesulfonic acid (AMPS), polyethylene oxide (PEO), and a combination thereof
29. The method of any one of claims 22 to 28, wherein the device further comprises one or more of:
(i) a photoinitiator;
(ii) an ultraviolet light source for solidifying the flowable hydrophilic tissue dressing material;
(iii) a mixer for mixing the flowable hydrophilic tissue dressing material; and
(iv) a delivery tube for delivering the flowable hydrophilic tissue dressing material.
30. The method of any one of claims 22 to 29, wherein the foam has a moisture vapor
transmission rate of about 250 g/m2/24 hours to about 1500 g/m2/24 hours.
31. The method of any one of claims 22 to 30, wherein the foam has a molecular weight of greater than or equal to about 100,000.
32. The method of any one of claims 22 to 31, wherein an interior of the device is sterile and/or the device is formed from metal, plastic, or a combination thereof.
PCT/US2020/039253 2019-06-25 2020-06-24 Devices for delivering a flowable hydrophilic tissue dressing material WO2020263900A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090092647A1 (en) * 2007-10-05 2009-04-09 Bayer Materialscience Ag Polyurethane foams for wound management
US20090157017A1 (en) * 2006-03-14 2009-06-18 Archel Ambrosio Bioresorbable foaming tissue dressing

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090157017A1 (en) * 2006-03-14 2009-06-18 Archel Ambrosio Bioresorbable foaming tissue dressing
US20090092647A1 (en) * 2007-10-05 2009-04-09 Bayer Materialscience Ag Polyurethane foams for wound management

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