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WO2017040091A1 - Products for sealing wounds using compressed materials and flexible absorbent binders - Google Patents

Products for sealing wounds using compressed materials and flexible absorbent binders Download PDF

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Publication number
WO2017040091A1
WO2017040091A1 PCT/US2016/048032 US2016048032W WO2017040091A1 WO 2017040091 A1 WO2017040091 A1 WO 2017040091A1 US 2016048032 W US2016048032 W US 2016048032W WO 2017040091 A1 WO2017040091 A1 WO 2017040091A1
Authority
WO
WIPO (PCT)
Prior art keywords
care device
wound care
compressed
binder
units
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2016/048032
Other languages
French (fr)
Inventor
Charles R. Tomsovic
John Gavin Macdonald
Andrew M. Long
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kimberly Clark Worldwide Inc
Kimberly Clark Corp
Original Assignee
Kimberly Clark Worldwide Inc
Kimberly Clark Corp
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 Kimberly Clark Worldwide Inc, Kimberly Clark Corp filed Critical Kimberly Clark Worldwide Inc
Publication of WO2017040091A1 publication Critical patent/WO2017040091A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/60Liquid-swellable gel-forming materials, e.g. super-absorbents
    • 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
    • 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

Definitions

  • This disclosure is directed to an appropriately-sized and -shaped wound care device that includes a combination of a flexible absorbent binder and various compressed substrates to which the binder is applied.
  • a multi-purpose absorbent crosslinkable binder coating that can be applied to a variety of articles to create an absorbent binder that is thin, durable, cost efficient, and non-obtrusive.
  • the present disclosure provides a wound care device including an elongated body having a proximal end and a distal end, wherein the body includes compressed material treated with a flexible absorbent binder.
  • the present disclosure also provides a wound care device including an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes one or more of a woven material, a nonwoven material, a foam material, and a film ; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements.
  • the present disclosure further provides a wound care device including an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes paper; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements, wherein the flexible absorbent binder includes a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate
  • Figure 1 is a perspective illustration of a wound care device of the present disclosure, where the wound care device includes multiple layers;
  • Figure 2 is a perspective illustration of the wound care device of Fig. 1 , where the multiple layers are replaced by compressed material;
  • Figure 3 is a perspective illustration of the wound care device of either Fig. 1 or Fig. 2, where the wound care device includes a sheath;
  • Figure 4 is a perspective illustration of the wound care device of Fig. 1 , Fig. 2, or Fig. 3, where the wound care device is configured to exhibit differential expansion from the distal end to the proximal end;
  • Figure 5 is a perspective illustration of a wound care device of the present disclosure, where the wound care device includes multiple zones;
  • Figures 6A-6F are photographic illustrations of an example of the wound care device of Fig. 1 ;
  • Figure 7 is a perspective view illustrating an assembly of compressed elements in an alternative aspect of the wound care device of Fig. 1 ;
  • Figure 8 is a perspective view illustrating an alternative aspect of the wound care device of Fig. 1 ;
  • Figure 9 is a perspective view illustrating an alternative aspect of the wound care device of Fig. 1 ;
  • Figures 10A-10D are photographic illustrations of another alternative aspect of the wound care device of Fig. 1 .
  • the present disclosure is directed to a combination of a crosslinkable flexible absorbent binder and various substrates to which the binder is applied.
  • the flexible absorbent binder includes a hydrophilic polymer having the capability of post-application, moisture-induced crosslinking.
  • the flexible absorbent binder can provide fluid retention properties in addition to adhesive properties. Additionally, the flexible absorbent binder is durable, relatively inexpensive to produce, and can be removed from surfaces and discarded after use.
  • a substrate is at least partially coated with the crosslinkable flexible absorbent binder, which forms an absorbent and lubricious hydrogel upon exposure to aqueous solutions.
  • the binder can release various additives, as described in greater detail below.
  • the flexible absorbent binder particularly in a fast-drying alcohol solution, provides a convenient means of applying absorbent capacity to a wide range of surfaces.
  • Application of the flexible absorbent binder, followed by evaporation of a carrier solvent within the binder results in formation of a binder capable of absorbing aqueous fluid or water vapor.
  • the binder can be applied to a substrate using any suitable application process, including knife over roll coating, or roll coating, either in a continuous coverage or a discontinuous or patterned coverage.
  • Printing applications or other suitable application techniques including gravure printing, screen, and jet printing, can be used.
  • the binder can also be applied to the substrate using a spray application.
  • Suitable substrates to which the binder can be applied include, but are not limited to, nonwoven, woven, and knitted fabrics; cellulosic paper and tissue sheets; plastic films, including polypropylene, low density polyethylene, high density polyethylene, linear low density polyethylene, and ultra-low density polyethylene; LYCRA stranded composites; elastomer net composites; various articles of clothing; non-porous surfaces; and foam material.
  • the flexible absorbent binder can be applied to a wound care device 10, as shown in Figs. 1 -5. More particularly, the binder can be applied to gauze, paper, or other woven or nonwoven material included in the wound care device 10, thereby providing absorbency and high integrity while preventing the material from adhering to any wounds.
  • the wound care device 10 can include a film and/or foam substrate to which the binder is applied, resulting in a high-absorbency wound care device 10 that does not adhere to wounds.
  • the flexible absorbent binder can act as a reservoir for releasable components that are to be delivered from the binder to a region outside of the binder or wound care device 10, such as, for example, a wound.
  • the binder can act to provide a controlled release of such compounds as wound healing agents, therapeutic agents, bioactive agents, antibiotics, bactericides, fungicides, drugs, growth factors, peptides, proteins, enzymes, emollients, antiseptics, anti-oxidants, wetting agents, and mixtures thereof.
  • Suitable wound healing agents can include, for example, chitosan, niacinamide ascorbate, or the chitosan niacinamide ascorbate salt.
  • the finished wound care device 10 can be generally cylindrical, although any suitable shape, size, and aspect ratio can be used.
  • the shape, size, and aspect ratio selected for the wound care device 10 depend primarily on the intended use of the wound care device 10.
  • the wound care device 10 has generally cylindrical body 40 and is intended to be used with bullet and puncture wounds. In another example, a flatter wound care device (not shown) might be used for lacerations.
  • the wound care device 10 is a simple, easy-to-employ wound treatment system for use by soldiers, medics, and first responders, among others. It is a rapid method for treating puncture-type wounds to stop bleeding and seal the hole.
  • the matrix absorbs wound exudate and swells to form a tight fit in the hole.
  • the basic concept of the wound care device 10 of the present disclosure is that a wound care device 10 having compressed absorbent material and a flexible absorbent binder is inserted into a wound.
  • the wound care device 10 by absorbing blood and other liquids and through its own release from compression, expands to fill the wound, thereby stopping or limiting blood flow from the wound.
  • the wound care device 10 can remain in place until removed by a medic or health care professional under the proper conditions.
  • the wound care device 10 illustrated in Fig. 1 includes multiple layers of
  • the wound care device 10 is essentially a stack of compressed disk elements 56.
  • a woven, nonwoven, or other material is treated with flexible absorbent binder.
  • the binder is allowed to dry; the material is then compressed into a disk element 56.
  • One or more disk elements 56 are stacked and held together using flexible absorbent binder, adhesive, or any other suitable attachment method.
  • Each disk element 56 in the wound care device 10 can be of a different material, different treatment type or quantity, and can include different additives described herein.
  • the wound care device 10 illustrated in Fig. 2 includes woven, nonwoven, or other material or materials compressed into a cylinder.
  • the wound care device 10 is essentially one or more woven, nonwoven, or other materials treated with flexible absorbent binder.
  • the binder is allowed to dry; the material is then compressed into a cylinder.
  • the material is held in its compressed form using friction, flexible absorbent binder, adhesive, or any other suitable method.
  • the wound care device 10 can also be manufactured by compressing individual elements 56 and then assembling them into a cylinder.
  • the wound care device 10 illustrated in Fig. 3 includes the wound care device 10 of Fig. 1 or Fig. 2 wrapped in a sheath 60 of woven, nonwoven, or other material or materials.
  • the sheath 60 helps to maintain the shape of the wound care device 10 prior to use, and helps to contain the materials of the wound care device 10 during use.
  • the sheath 60 is held in place using friction, flexible absorbent binder, adhesive, or any other suitable method.
  • Fig. 4 illustrates the wound care device 10 of Fig. 1 , Fig. 2, or Fig. 3, where the wound care device 10 is configured to exhibit differential expansion from the distal end 44 to the proximal end 48.
  • the wound care device 10 expands at different rates along its longitudinal axis 52 to produce an expanded body 70, allowing for greater pressure at a wound entrance to help hold the wound care device 10 in place, and to allow the wound care device 10 to fill a wound that is not uniform in diameter.
  • This differential expansion can be accomplished by using more material toward the proximal end 48, requiring greater pressure to compress the material into a cylinder, thereby providing greater expansion force.
  • the differential expansion can also be accomplished by changing the material type along the longitudinal axis 52 where materials that expand more are placed toward the proximal end 48. Finally, the differential expansion can be accomplished by increasing the amount of flexible absorbent binder used from the distal end 44 to the proximal end 48.
  • Fig. 5 illustrates a wound care device 10 of the present disclosure, where the wound care device 10 includes multiple zones.
  • the wound care device 10 includes a distal zone 80, a central zone 84, and a proximal zone 88.
  • Each zone 80, 84, 88 can be of a different material, compression, treatment, additive, thickness, shape, aspect ratio as desired for an intended use.
  • the wound care device 10 of the present application provides immediate wound care for different traumatic battlefield or first response applications.
  • the wound care device 10 is highly portable and can be self-administered if needed. It can also provide customized wound treatment including specified additives for certain wounds, such as an additive to help treat chemical burns.
  • sealing a wound, while limiting blood loss, also protects the wound from debris and contaminants that might otherwise enter the wound.
  • the wound care device 10 can be an assembly of elements 56 that are compressed prior to being assembled, or the wound care device 10 can be an assembly of uncompressed or partially-compressed elements 56 that are assembled and then compressed.
  • the wound care device 10 can include multiple shapes, orientations, features, designs, etc. Non-limiting examples of these are illustrated in Figs. 7-10.
  • Fig. 7 illustrates two different aspects of an assembly of compressed elements 56.
  • individual elements 56 are compressed, in this case to elongate cylinders, and then the individual elements 56 are assembled to form a wound care device 10.
  • the assembly of individual elements 56 can be held together using flexible absorbent binder, adhesive, a sheath, or any other suitable method.
  • Fig. 8 illustrates an example of a wound care device 10 that can include multiple shapes, orientations, features, designs, etc.
  • a portion of the wound care device 10 includes ridges 92 that are generally parallel to the longitudinal axis 52 of the wound care device 10, whereas another portion includes rings 96 in a plane perpendicular to the longitudinal axis 52 of the wound care device 10.
  • Fig. 9 illustrates an example of a wound care device 10 that is an assembly of uncompressed or partially-compressed elements 56 that are assembled and then compressed.
  • the uncompressed elements 56 can, for example, have multiple planes and angles that can be useful, once expanded, in treating an irregularly-shaped wound.
  • Fig. 10 illustrates an example of a wound care device 10 that is compressed, and then partially split generally perpendicularly to the longitudinal axis 52.
  • One split will typically generate two lobes 98; while two splits will typically generate four lobes 98.
  • splits or notches also help the wound care device 10 in treating irregularly-shaped wounds.
  • the flexible absorbent binder is an oligomeric pre-superabsorbent and suitably includes about 15%-99.8% by mass of monoethylenically unsaturated polymer units, suitably about 25%-90% by mass, particularly about 30%-80% by mass, or about 50%-70% by mass.
  • Suitable monoethylenically unsaturated polymer units include without limitation monoethylenically unsaturated carboxylic acid units and salts thereof, monoethylenically unsaturated sulphonic acid units and salts thereof, and monoethylenically unsaturated phosphonic acid units and salts thereof.
  • Suitable monoethylenically unsaturated monomers that can be used to form the monoethylenically unsaturated polymer units include without limitation:
  • Carboxyl group-containing monomers including monoethylenically unsaturated mono- or poly-carboxylic acids, such as (meth)acrylic acid (meaning acrylic acid or methacrylic acid; similar notations are used hereinafter), maleic acid, fumaric acid, crotonic acid, sorbic acid, itaconic acid, and cinnamic acid;
  • alkali metal salts, ammonium salts, amine salts, etc. of monoethylenically unsaturated mono- or poly-carboxylic acids (such as sodium (meth)acrylate, trimethylamine
  • vinyl sulfonic acid such as vinylsulfonic acid, allyl sulfonic acid, vinyltoluenesulfonic acid, styrene sulfonic acid
  • (meth)acrylic sulfonic acids such as sulfopropyl (meth)acrylate, 2- hydroxy-3-(meth)acryloxy propyl sulfonic acid
  • Sulfonic acid salt group-containing monomers including alkali metal salts, ammonium salts, amine salts of sulfonic acid group containing monomers as mentioned above; and/or
  • Amide group-containing monomers including vinylformamide, (meth)acrylamide, N-alkyl (meth)acrylamides (such as N-methylacrylamide, N-hexylacrylamide), N,N-dialkyl (meth)acryl amides (such as ⁇ , ⁇ -dimethylacrylamide, N,N-di-n-propylacrylamide), N- hydroxyalkyl (meth)acrylamides [such as N-methylol (meth)acrylamide, N-hydroxyethyl (meth)acrylamide], ⁇ , ⁇ -dihydroxyalkyl (meth)acrylamides [such as N,N-dihydroxyethyl
  • (meth)acrylamide 3-acrylamidopropyl trimethyl ammonium chloride
  • vinyl lactams such as N-vinylpyrrolidone
  • the flexible absorbent binder also includes about 0.1 %-20% by mass of polyacrylate ester units, such as acrylate and/or methacrylate ester units, that include an alkoxysilane functionality.
  • the acrylate and/or methacrylate ester units are copolymerized with the monoethylenically unsaturated monomer units.
  • the flexible absorbent binder can include about 0.5%-15% by mass of the acrylate and/or methacrylate ester units, for instance about 1 .0%-10% by mass, for instance about 1 .5%-5.5% by mass.
  • the alkoxysilane functionality is a functional group or moiety that reacts with water to form a silanol group.
  • the term "monomer(s)" as used herein includes monomers, oligomers, polymers, mixtures of monomers, oligomers and/or polymers, and any other reactive chemical species which is capable of co-polymerization with monoethylenically unsaturated carboxylic, sulphonic or phosphoric acid or salts thereof.
  • Ethylenically unsaturated monomers containing a trialkoxy silane functional group are appropriate for this disclosure and are desired.
  • Suitable ethylenically unsaturated monomers include acrylates and methacrylates.
  • a particularly ethylenically unsaturated monomer containing a trialkoxy silane functional group is methacryloxypropyl trimethoxy silane, commercially available from Dow Corning, having offices in Midland, Mich., under the trade designation Z-6030 Silane.
  • Suitable ethylenically unsaturated monomers containing a trialkoxy silane functional group include, but are not limited to, methacryloxyethyl trimethoxy silane, methacryloxypropyl triethoxy silane, methacryloxypropyl tripropoxy silane, acryloxypropylm ethyl dimethoxy silane, 3- acryloxypropyl trimethoxy silane, 3-methacryloxypropylmethyl diethoxy silane, 3- methacryloxypropylmethyl dimethoxy silane, and 3-methacryloxypropyl tris(methoxyethoxy) silane.
  • a monomer capable of copolymerization that can subsequently be reacted with a compound containing a trialkoxy silane functional group or a moiety that reacts with water to form a silanol group.
  • a monomer can contain, but is not limited to, an amine or an alcohol.
  • An amine group incorporated into the co-polymer can subsequently be reacted with, for example, but not limited to, (3- chloropropyl)trimethoxysilane.
  • An alcohol group incorporated into the copolymer can subsequently be reacted with, for example, but not limited to, tetramethoxysilane.
  • the flexible absorbent binder also includes about 0.1 %-75% by mass polyolefin glycol and/or polyolefin oxide units, suitably about 5%-75% by mass, particularly about 10%-60% by mass, particularly about 20%-50% by mass, particularly about 30%-40% by mass.
  • the polyolefin glycol or oxide can be a glycol or oxide of an olefin polymer having about 2-4 carbon atoms. Polyethylene glycol, polyethylene oxide, polypropylene glycol and polypropylene oxide are examples of suitable polymer units.
  • the polyolefin glycol and/or polyolefin oxide can include on average about 4 to 15,000 glycol and/or oxide units per molecule.
  • the weight average molecular weight of polyolefin glycol units can range from about 200 to 8000. When polyolefin oxide units are employed, they can have a weight average molecular weight of about 100,000 to about 600,000.
  • Polyolefin glycols and polyolefin oxides are commercially available, and are common.
  • a pre-formed polyolefin glycol and/or oxide can be dissolved or dispersed in a reaction vessel which includes an aqueous solvent or carrier, an organic solvent or carrier such as ethanol, or a miscible combination of aqueous and organic solvent or carrier.
  • the monomers used to form the monoethylenically unsaturated polymer units and the polyacrylate ester units are added to the solution and polymerized using a template polymerization process in which the polyolefin glycol or oxide serves as a template polymer.
  • the polar groups of the monomers for instance the acid groups of acrylic acid, are attracted to the polyolefin glycol and/or polyolefin oxide through hydrogen bonding.
  • radical polymerizing chains can become attached to the template polymer, resulting in grafting of polyolefin glycol and/or oxide to the copolymer being formed.
  • the resulting flexible absorbent binder includes the polyolefin glycol and/or oxide attached to, and/or blended with, the copolymer of the monoethylenically unsaturated polymer units and the acrylate or methacrylate ester units that include the alkoxysilane functionality.
  • the polymerization can be initiated using a variety of methods, including without limitation thermal energy, ultraviolet light, and redox chemical reactions.
  • a solution of the above ingredients can be added to an initiator solution at a temperature suitable for generating free radicals, for instance about 50 ° C to 90° C.
  • An initiator can be prepared by dissolving an initiator in an organic or aqueous solvent.
  • a suitable class of initiators are organic peroxides and azo compounds, with benzoyl peroxide and azobisisobutylnitrile (ABN) as examples.
  • Compounds containing 0-0 bonds; i.e., peroxides are commonly used as initiators for polymerization.
  • Such commonly used peroxide initiators include: alkyl, dialkyl, diaryl and arylalkyl peroxides such as cumyl peroxide, t-butyl peroxide, di-t-butyl peroxide, dicumyl peroxide, cumyl butyl peroxide, 1 ,1 -di-t-butyl peroxy-3,5,5-trimethylcyclohexane, 2,5-dimethyl-2,5-di(t-butylperoxy)hexane, 2,5-dimethyl-2,5-bis(t-butylperoxy)hexyne-3 and bis(a-t-butyl peroxyisopropylbenzene); acyl peroxides such as
  • peroxyesters such as t-butyl peroxypivalate, t-butyl peroctoate, t-butyl perbenzoate, 2,5- dimethylhexyl-2,5-di(perbenzoate) and t-butyl di(perphthalate); alkylsulfonyl peroxides; dialkyl peroxymonocarbonates; dialkyl peroxydicarbonates; diperoxyketals; ketone peroxides such as cyclohexanone peroxide and methyl ethyl ketone peroxide.
  • azo compounds such as 2,2'-azobisisobutyronitrile abbreviated as AIBN, 2,2'-azobis(2,4- dimethylpentanenitrile) and 1 ,1 '-azobis(cyclohexanecarbonitrile) can be used as the initiator.
  • AIBN 2,2'-azobisisobutyronitrile
  • 2,2'-azobis(2,4- dimethylpentanenitrile) and 1 ,1 '-azobis(cyclohexanecarbonitrile) can be used as the initiator.
  • the flexible absorbent binder is made by combining a first aqueous monomer solution including a reducing polymerization initiator with a second aqueous monomer solution including an oxidizing polymerization initiator, wherein the initiators react to form a binder coating.
  • the first aqueous monomer solution further includes a
  • the second aqueous monomer solution includes a monoethylenically unsaturated monomer.
  • One or both solutions can include the polyolefin glycol and/or polyolefin oxide template polymer.
  • the binder coating is formed in about 100 minutes or less, or 60 minutes or less, desirably in about 30 minutes or less, or about 15 minutes or less, or about 10 minutes or less.
  • the pH of the first and/or second aqueous monomer solution is adjusted to about
  • the pH of the first aqueous solution can be adjusted prior to the addition of the ethylenically unsaturated monomer. Desirably, the pH of the first aqueous monomer solution is adjusted prior to the addition of the reducing polymerization initiator.
  • the pH of the second aqueous solution can be adjusted prior to the addition of the oxidizing polymerization initiator.
  • the pH of the combined first and second aqueous monomer solutions can be adjusted to about 4.5 to 8, suitably about 5.5 to about 7.0. If desired, the pH can be increased after polymerization is complete, by addition of a suitable basic solution. The extent of neutralization can be used to adjust the properties of the binder.
  • Greater neutralization of the acid functional components generally provides for greater absorbent capacity, while adhesiveness is generally enhanced with more acid functionality.
  • the amounts of the polymerization ingredients added to the first and second aqueous solutions are selected so as to produce the flexible absorbent binder having the binder described above.
  • a surfactant can be added to the first and/or second aqueous monomer solution to disperse the ethylenically unsaturated monomer.
  • One surfactant suitable for use in the present disclosure is a dioctyl sodium sulfosuccinate available under the trademark AEROSOL OT from Cytec Industries, Inc. of Paterson, N.J.
  • the first aqueous monomer solution further includes a reducing polymerization initiator.
  • Suitable reducing polymerization initiators include, but are not limited to, ascorbic acid, alkali metal sulfites, alkali metal bisulfites, ammonium sulfite, ammonium bisulfite, alkali metal hydrogen sulfite, ferrous metal salts such as ferrous sulfates, sugars, aldehydes, primary and secondary alcohols, and combinations thereof.
  • the reducing polymerization initiator includes ascorbic acid.
  • the second aqueous monomer solution further includes an oxidizing polymerization initiator.
  • Suitable oxidizing initiators include, but are not limited to, hydrogen peroxide, alkali metal persulfates, ammonium persulfate, alkylhydroperoxides, peresters, diacryl peroxides, silver salts, and combinations thereof.
  • the oxidizing polymerization initiator includes hydrogen peroxide.
  • the reducing polymerization initiator reacts with the oxidizing polymerization initiator, e.g. a redox reaction, thereby initiating a polymerization reaction to form a binder coating including a monoethylenically unsaturated monomer and an ethylenically unsaturated monomer that has post-application, moisture-induced crosslinking capability.
  • the oxidizing polymerization initiator e.g. a redox reaction
  • Standard paper towels were cut into strips and compressed, but were left untreated as a control.
  • Other paper towels were treated with flexible absorbent binder (FAB, 1 12% add-on), dried, and cut into strips. These strips were then folded and compressed (to 3K, 5K, 8K lbs.) in a circular compression mold to produce compressed disks.
  • FAB flexible absorbent binder
  • FIG. 6A two sample types were produced as illustrated in Fig. 6A: compressed, untreated paper strips (top row), and compressed, treated paper disks (numbered disks in bottom row).
  • 1 g of blood from calf liver was placed in small beakers (10ml) to mimic a traumatic puncture wound such as a bullet hole (see Fig. 6B). The strips and the disks were also placed in the small beakers (see Fig.
  • Figs. 6C control on left). After five minutes, the control compressed paper absorbed the blood but distorted to leave gaps (see Figs. 6D-6F).
  • the FAB/paper disk sample absorbed the blood, swelled, and plugged the hole (see Figs. 6D-6F).
  • Figs. 6E and 6F illustrate the level of sealing, showing the small beakers on their sides and inverted.
  • a wound care device in a first particular aspect, includes an elongated body having a proximal end and a distal end, wherein the body includes compressed material treated with a flexible absorbent binder.
  • a second particular aspect includes the first particular aspect, wherein the body is an assembly of compressed elements, and wherein at least one of the elements includes compressed material treated with a flexible absorbent binder.
  • a third particular aspect includes the first particular aspect and/or the second particular aspect, wherein the body includes an elongate portion and a ring portion.
  • a fourth particular aspect includes one or more of aspects 1 -3, wherein the body has a shape prior to compression, wherein the shape includes multiple planes and multiple angles.
  • a fifth particular aspect includes one or more of aspects 1 -4, wherein the
  • compressed material has a level of compression, and wherein the level of compression varies from the distal end to the proximal end.
  • a sixth particular aspect includes one or more of aspects 1 -5, wherein the body includes a first split in the distal end.
  • a seventh particular aspect includes one or more of aspects 1 -6, wherein the body includes a second split in the distal end.
  • An eighth particular aspect includes one or more of aspects 1 -7, wherein the body includes an additive having a concentration, and wherein the concentration of the additive varies from the distal end to the proximal end.
  • a ninth particular aspect includes one or more of aspects 1 -8, further comprising a sheath at least partially enveloping the body.
  • a tenth particular aspect includes one or more of aspects 1 -9, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film.
  • An eleventh particular aspect includes one or more of aspects 1 -10, wherein the body comprises a plurality of compressed absorbent elements.
  • a twelfth particular aspect includes one or more of aspects 1 -1 1 , wherein the flexible absorbent binder is an oligomeric pre-superabsorbent including a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate ester units; the copolymer establishes intimate contact with the substrate; the copolymer crosslinks after establishing intimate contact with the substrate; the copolymer assumes a final shape on the substrate to form the binder; and the binder absorbs water vapor at 22° C. and 50% relative humidity at a rate of at least 4 weight percent per hour, for at least two hours.
  • a thirteenth particular aspect includes one or more of aspects 1 -12, wherein the compressed material includes one or more of a woven material, a nonwoven material, a foam material, and a film.
  • a fourteenth particular aspect includes one or more of aspects 1 -13, wherein the body further comprises a wound healing agent.
  • a fifteenth particular aspect includes one or more of aspects 1 -14, wherein the body further comprises a distal zone and a proximal zone.
  • a sixteenth particular aspect includes one or more of aspects 1 -15, wherein the distal zone and the proximal zone differ in one or more of their material, chemical, physical, and additive properties.
  • a seventeenth particular aspect includes one or more of aspects 1 -16, wherein the compressed material includes paper.
  • wound care device includes an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes one or more of a woven material, a nonwoven material, a foam material, and a film ; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements.
  • a nineteenth particular aspect includes the eighteenth particular aspect, wherein the compressed absorbent elements differ in one or more of their material, chemical, physical, and additive properties.
  • wound care device includes an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes paper; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements, wherein the flexible absorbent binder includes a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate este

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Abstract

A wound care device includes an elongated body having a proximal end and a distal end, wherein the body includes compressed material treated with a flexible absorbent binder. In another aspect, a wound care device includes an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes one or more of a woven material, a nonwoven material, a foam material, and a film; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements.

Description

PRODUCTS FOR SEALING WOUNDS USING COMPRESSED MATERIALS AND
FLEXIBLE ABSORBENT BINDERS
BACKGROUND
Providing treatment by sealing a wound in the field, particularly a puncture wound such as a bullet hole or other traumatic injury, is a challenge. Blood loss in addition to the initial trauma from such a wound is a significant issue. Because of this, there is a need for an easy-to-use and effective wound care device that allows a medic, first responder, soldier, or layperson to both absorb blood and limit further loss of blood.
SUMMARY
This disclosure is directed to an appropriately-sized and -shaped wound care device that includes a combination of a flexible absorbent binder and various compressed substrates to which the binder is applied. A multi-purpose absorbent crosslinkable binder coating that can be applied to a variety of articles to create an absorbent binder that is thin, durable, cost efficient, and non-obtrusive. By combining a flexible absorbent binder (FAB) and compressed substrate materials, an expanding, sealing, absorbent wound care device can be made to treat wounds and limit blood loss.
The present disclosure provides a wound care device including an elongated body having a proximal end and a distal end, wherein the body includes compressed material treated with a flexible absorbent binder.
The present disclosure also provides a wound care device including an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes one or more of a woven material, a nonwoven material, a foam material, and a film ; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements.
The present disclosure further provides a wound care device including an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes paper; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements, wherein the flexible absorbent binder includes a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate ester units; the copolymer establishes intimate contact with the substrate; the copolymer crosslinks after establishing intimate contact with the substrate; the copolymer assumes a final shape on the substrate to form the binder; and the binder absorbs water vapor at 22° C and 50% relative humidity at a rate of at least 4 weight percent per hour, for at least two hours.
BRIEF DESCRIPTION OF THE DRAWINGS
The present disclosure will be more fully understood, and further features will become apparent, when reference is made to the following detailed description and the accompanying drawings. The drawings are merely representative and are not intended to limit the scope of the claims.
Figure 1 is a perspective illustration of a wound care device of the present disclosure, where the wound care device includes multiple layers;
Figure 2 is a perspective illustration of the wound care device of Fig. 1 , where the multiple layers are replaced by compressed material;
Figure 3 is a perspective illustration of the wound care device of either Fig. 1 or Fig. 2, where the wound care device includes a sheath;
Figure 4 is a perspective illustration of the wound care device of Fig. 1 , Fig. 2, or Fig. 3, where the wound care device is configured to exhibit differential expansion from the distal end to the proximal end;
Figure 5 is a perspective illustration of a wound care device of the present disclosure, where the wound care device includes multiple zones;
Figures 6A-6F are photographic illustrations of an example of the wound care device of Fig. 1 ;
Figure 7 is a perspective view illustrating an assembly of compressed elements in an alternative aspect of the wound care device of Fig. 1 ; Figure 8 is a perspective view illustrating an alternative aspect of the wound care device of Fig. 1 ;
Figure 9 is a perspective view illustrating an alternative aspect of the wound care device of Fig. 1 ; and
Figures 10A-10D are photographic illustrations of another alternative aspect of the wound care device of Fig. 1 .
Repeat use of reference characters in the present specification and drawings is intended to represent the same or analogous features or elements of the present disclosure. The drawings are representational and are not necessarily drawn to scale. Certain proportions thereof might be exaggerated, while others might be minimized.
DETAILED DESCRIPTION
The present disclosure is directed to a combination of a crosslinkable flexible absorbent binder and various substrates to which the binder is applied. The flexible absorbent binder includes a hydrophilic polymer having the capability of post-application, moisture-induced crosslinking. The flexible absorbent binder can provide fluid retention properties in addition to adhesive properties. Additionally, the flexible absorbent binder is durable, relatively inexpensive to produce, and can be removed from surfaces and discarded after use.
In this disclosure, a substrate is at least partially coated with the crosslinkable flexible absorbent binder, which forms an absorbent and lubricious hydrogel upon exposure to aqueous solutions. Also, upon exposure to aqueous solutions, the binder can release various additives, as described in greater detail below. The flexible absorbent binder, particularly in a fast-drying alcohol solution, provides a convenient means of applying absorbent capacity to a wide range of surfaces. Application of the flexible absorbent binder, followed by evaporation of a carrier solvent within the binder, results in formation of a binder capable of absorbing aqueous fluid or water vapor. The binder can be applied to a substrate using any suitable application process, including knife over roll coating, or roll coating, either in a continuous coverage or a discontinuous or patterned coverage. Printing applications or other suitable application techniques, including gravure printing, screen, and jet printing, can be used. The binder can also be applied to the substrate using a spray application. Suitable substrates to which the binder can be applied include, but are not limited to, nonwoven, woven, and knitted fabrics; cellulosic paper and tissue sheets; plastic films, including polypropylene, low density polyethylene, high density polyethylene, linear low density polyethylene, and ultra-low density polyethylene; LYCRA stranded composites; elastomer net composites; various articles of clothing; non-porous surfaces; and foam material.
In the present disclosure, the flexible absorbent binder can be applied to a wound care device 10, as shown in Figs. 1 -5. More particularly, the binder can be applied to gauze, paper, or other woven or nonwoven material included in the wound care device 10, thereby providing absorbency and high integrity while preventing the material from adhering to any wounds. Alternatively, the wound care device 10 can include a film and/or foam substrate to which the binder is applied, resulting in a high-absorbency wound care device 10 that does not adhere to wounds.
Another feature of the flexible absorbent binder is that it can act as a reservoir for releasable components that are to be delivered from the binder to a region outside of the binder or wound care device 10, such as, for example, a wound. In this aspect, the binder can act to provide a controlled release of such compounds as wound healing agents, therapeutic agents, bioactive agents, antibiotics, bactericides, fungicides, drugs, growth factors, peptides, proteins, enzymes, emollients, antiseptics, anti-oxidants, wetting agents, and mixtures thereof. Suitable wound healing agents can include, for example, chitosan, niacinamide ascorbate, or the chitosan niacinamide ascorbate salt.
As shown in Figs. 1 -5 as examples, the finished wound care device 10 can be generally cylindrical, although any suitable shape, size, and aspect ratio can be used. The shape, size, and aspect ratio selected for the wound care device 10 depend primarily on the intended use of the wound care device 10. In the examples shown in Figs. 1 -5, the wound care device 10 has generally cylindrical body 40 and is intended to be used with bullet and puncture wounds. In another example, a flatter wound care device (not shown) might be used for lacerations.
The wound care device 10 is a simple, easy-to-employ wound treatment system for use by soldiers, medics, and first responders, among others. It is a rapid method for treating puncture-type wounds to stop bleeding and seal the hole. The matrix absorbs wound exudate and swells to form a tight fit in the hole. The basic concept of the wound care device 10 of the present disclosure is that a wound care device 10 having compressed absorbent material and a flexible absorbent binder is inserted into a wound. The wound care device 10, by absorbing blood and other liquids and through its own release from compression, expands to fill the wound, thereby stopping or limiting blood flow from the wound. The wound care device 10 can remain in place until removed by a medic or health care professional under the proper conditions. The wound care device 10 illustrated in Fig. 1 includes multiple layers of
compressed nonwoven material elements 56. In this particular example, the wound care device 10 is essentially a stack of compressed disk elements 56. For each disk element 56, a woven, nonwoven, or other material is treated with flexible absorbent binder. The binder is allowed to dry; the material is then compressed into a disk element 56. One or more disk elements 56 are stacked and held together using flexible absorbent binder, adhesive, or any other suitable attachment method. Each disk element 56 in the wound care device 10 can be of a different material, different treatment type or quantity, and can include different additives described herein.
The wound care device 10 illustrated in Fig. 2 includes woven, nonwoven, or other material or materials compressed into a cylinder. In this particular example, the wound care device 10 is essentially one or more woven, nonwoven, or other materials treated with flexible absorbent binder. The binder is allowed to dry; the material is then compressed into a cylinder. The material is held in its compressed form using friction, flexible absorbent binder, adhesive, or any other suitable method. The wound care device 10 can also be manufactured by compressing individual elements 56 and then assembling them into a cylinder.
The wound care device 10 illustrated in Fig. 3 includes the wound care device 10 of Fig. 1 or Fig. 2 wrapped in a sheath 60 of woven, nonwoven, or other material or materials. The sheath 60 helps to maintain the shape of the wound care device 10 prior to use, and helps to contain the materials of the wound care device 10 during use. The sheath 60 is held in place using friction, flexible absorbent binder, adhesive, or any other suitable method.
Fig. 4 illustrates the wound care device 10 of Fig. 1 , Fig. 2, or Fig. 3, where the wound care device 10 is configured to exhibit differential expansion from the distal end 44 to the proximal end 48. Although having a cylindrical body 40 in its pre-use state, the wound care device 10 expands at different rates along its longitudinal axis 52 to produce an expanded body 70, allowing for greater pressure at a wound entrance to help hold the wound care device 10 in place, and to allow the wound care device 10 to fill a wound that is not uniform in diameter. This differential expansion can be accomplished by using more material toward the proximal end 48, requiring greater pressure to compress the material into a cylinder, thereby providing greater expansion force. The differential expansion can also be accomplished by changing the material type along the longitudinal axis 52 where materials that expand more are placed toward the proximal end 48. Finally, the differential expansion can be accomplished by increasing the amount of flexible absorbent binder used from the distal end 44 to the proximal end 48.
Fig. 5 illustrates a wound care device 10 of the present disclosure, where the wound care device 10 includes multiple zones. In the illustrated example, the wound care device 10 includes a distal zone 80, a central zone 84, and a proximal zone 88. Each zone 80, 84, 88 can be of a different material, compression, treatment, additive, thickness, shape, aspect ratio as desired for an intended use.
The wound care device 10 of the present application provides immediate wound care for different traumatic battlefield or first response applications. The wound care device 10 is highly portable and can be self-administered if needed. It can also provide customized wound treatment including specified additives for certain wounds, such as an additive to help treat chemical burns. In addition, sealing a wound, while limiting blood loss, also protects the wound from debris and contaminants that might otherwise enter the wound.
In other aspects of the present application, the wound care device 10 can be an assembly of elements 56 that are compressed prior to being assembled, or the wound care device 10 can be an assembly of uncompressed or partially-compressed elements 56 that are assembled and then compressed. In still other aspects of the present application, the wound care device 10 can include multiple shapes, orientations, features, designs, etc. Non-limiting examples of these are illustrated in Figs. 7-10.
Fig. 7 illustrates two different aspects of an assembly of compressed elements 56.
In this aspect, individual elements 56 are compressed, in this case to elongate cylinders, and then the individual elements 56 are assembled to form a wound care device 10. The assembly of individual elements 56 can be held together using flexible absorbent binder, adhesive, a sheath, or any other suitable method.
Fig. 8 illustrates an example of a wound care device 10 that can include multiple shapes, orientations, features, designs, etc. In this case, a portion of the wound care device 10 includes ridges 92 that are generally parallel to the longitudinal axis 52 of the wound care device 10, whereas another portion includes rings 96 in a plane perpendicular to the longitudinal axis 52 of the wound care device 10.
Fig. 9 illustrates an example of a wound care device 10 that is an assembly of uncompressed or partially-compressed elements 56 that are assembled and then compressed. The uncompressed elements 56 can, for example, have multiple planes and angles that can be useful, once expanded, in treating an irregularly-shaped wound. Fig. 10 illustrates an example of a wound care device 10 that is compressed, and then partially split generally perpendicularly to the longitudinal axis 52. One split will typically generate two lobes 98; while two splits will typically generate four lobes 98. Such splits or notches also help the wound care device 10 in treating irregularly-shaped wounds.
The flexible absorbent binder is an oligomeric pre-superabsorbent and suitably includes about 15%-99.8% by mass of monoethylenically unsaturated polymer units, suitably about 25%-90% by mass, particularly about 30%-80% by mass, or about 50%-70% by mass. Suitable monoethylenically unsaturated polymer units include without limitation monoethylenically unsaturated carboxylic acid units and salts thereof, monoethylenically unsaturated sulphonic acid units and salts thereof, and monoethylenically unsaturated phosphonic acid units and salts thereof. Suitable monoethylenically unsaturated monomers that can be used to form the monoethylenically unsaturated polymer units include without limitation:
a) Carboxyl group-containing monomers including monoethylenically unsaturated mono- or poly-carboxylic acids, such as (meth)acrylic acid (meaning acrylic acid or methacrylic acid; similar notations are used hereinafter), maleic acid, fumaric acid, crotonic acid, sorbic acid, itaconic acid, and cinnamic acid;
b) Carboxylic acid anhydride group-containing monomers, including
monoethylenically unsaturated polycarboxylic acid anhydrides (such as maleic anhydride); c) Carboxylic acid salt group-containing monomers including water-soluble salts
(alkali metal salts, ammonium salts, amine salts, etc.) of monoethylenically unsaturated mono- or poly-carboxylic acids (such as sodium (meth)acrylate, trimethylamine
(meth)acrylate, triethanolamine (meth)acrylate), sodium maleate, methylamine maleate; d) Sulfonic acid group-containing monomers, including aliphatic or aromatic vinyl sulfonic acids (such as vinylsulfonic acid, allyl sulfonic acid, vinyltoluenesulfonic acid, styrene sulfonic acid), (meth)acrylic sulfonic acids [such as sulfopropyl (meth)acrylate, 2- hydroxy-3-(meth)acryloxy propyl sulfonic acid];
e) Sulfonic acid salt group-containing monomers, including alkali metal salts, ammonium salts, amine salts of sulfonic acid group containing monomers as mentioned above; and/or
f) Amide group-containing monomers, including vinylformamide, (meth)acrylamide, N-alkyl (meth)acrylamides (such as N-methylacrylamide, N-hexylacrylamide), N,N-dialkyl (meth)acryl amides (such as Ν,Ν-dimethylacrylamide, N,N-di-n-propylacrylamide), N- hydroxyalkyl (meth)acrylamides [such as N-methylol (meth)acrylamide, N-hydroxyethyl (meth)acrylamide], Ν,Ν-dihydroxyalkyl (meth)acrylamides [such as N,N-dihydroxyethyl
(meth)acrylamide], 3-acrylamidopropyl trimethyl ammonium chloride, vinyl lactams (such as N-vinylpyrrolidone).
The flexible absorbent binder also includes about 0.1 %-20% by mass of polyacrylate ester units, such as acrylate and/or methacrylate ester units, that include an alkoxysilane functionality. The acrylate and/or methacrylate ester units are copolymerized with the monoethylenically unsaturated monomer units. In particular, the flexible absorbent binder can include about 0.5%-15% by mass of the acrylate and/or methacrylate ester units, for instance about 1 .0%-10% by mass, for instance about 1 .5%-5.5% by mass.
The alkoxysilane functionality is a functional group or moiety that reacts with water to form a silanol group.
The term "monomer(s)" as used herein includes monomers, oligomers, polymers, mixtures of monomers, oligomers and/or polymers, and any other reactive chemical species which is capable of co-polymerization with monoethylenically unsaturated carboxylic, sulphonic or phosphoric acid or salts thereof. Ethylenically unsaturated monomers containing a trialkoxy silane functional group are appropriate for this disclosure and are desired. Suitable ethylenically unsaturated monomers include acrylates and methacrylates. A particularly ethylenically unsaturated monomer containing a trialkoxy silane functional group is methacryloxypropyl trimethoxy silane, commercially available from Dow Corning, having offices in Midland, Mich., under the trade designation Z-6030 Silane. Other suitable ethylenically unsaturated monomers containing a trialkoxy silane functional group include, but are not limited to, methacryloxyethyl trimethoxy silane, methacryloxypropyl triethoxy silane, methacryloxypropyl tripropoxy silane, acryloxypropylm ethyl dimethoxy silane, 3- acryloxypropyl trimethoxy silane, 3-methacryloxypropylmethyl diethoxy silane, 3- methacryloxypropylmethyl dimethoxy silane, and 3-methacryloxypropyl tris(methoxyethoxy) silane. However, it is contemplated that a wide range of vinyl and acrylic monomers having trialkoxy silane functional groups or a moiety that reacts easily with water to form a silanol group, such as a chlorosilane or an acetoxysilane, provide the desired effects are effective monomers for copolymerization in accordance with the present disclosure.
In addition to monomers capable of co-polymerization that contain a trialkoxy silane functional group, it is also feasible to use a monomer capable of copolymerization that can subsequently be reacted with a compound containing a trialkoxy silane functional group or a moiety that reacts with water to form a silanol group. Such a monomer can contain, but is not limited to, an amine or an alcohol. An amine group incorporated into the co-polymer can subsequently be reacted with, for example, but not limited to, (3- chloropropyl)trimethoxysilane. An alcohol group incorporated into the copolymer can subsequently be reacted with, for example, but not limited to, tetramethoxysilane.
The flexible absorbent binder also includes about 0.1 %-75% by mass polyolefin glycol and/or polyolefin oxide units, suitably about 5%-75% by mass, particularly about 10%-60% by mass, particularly about 20%-50% by mass, particularly about 30%-40% by mass. The polyolefin glycol or oxide can be a glycol or oxide of an olefin polymer having about 2-4 carbon atoms. Polyethylene glycol, polyethylene oxide, polypropylene glycol and polypropylene oxide are examples of suitable polymer units. The polyolefin glycol and/or polyolefin oxide can include on average about 4 to 15,000 glycol and/or oxide units per molecule. The weight average molecular weight of polyolefin glycol units can range from about 200 to 8000. When polyolefin oxide units are employed, they can have a weight average molecular weight of about 100,000 to about 600,000.
Polyolefin glycols and polyolefin oxides are commercially available, and are common. To prepare the flexible absorbent binder of the disclosure, a pre-formed polyolefin glycol and/or oxide can be dissolved or dispersed in a reaction vessel which includes an aqueous solvent or carrier, an organic solvent or carrier such as ethanol, or a miscible combination of aqueous and organic solvent or carrier. The monomers used to form the monoethylenically unsaturated polymer units and the polyacrylate ester units are added to the solution and polymerized using a template polymerization process in which the polyolefin glycol or oxide serves as a template polymer. Before initiation, the polar groups of the monomers, for instance the acid groups of acrylic acid, are attracted to the polyolefin glycol and/or polyolefin oxide through hydrogen bonding. The steric alignment of the monomers, with the polyolefin glycol and/or oxide serving as backbone, aids in the polymerization and typically increases the chain length of the polymerizing unit. During the polymerization, radical polymerizing chains can become attached to the template polymer, resulting in grafting of polyolefin glycol and/or oxide to the copolymer being formed.
However, this graft polymerization need not occur. The resulting flexible absorbent binder includes the polyolefin glycol and/or oxide attached to, and/or blended with, the copolymer of the monoethylenically unsaturated polymer units and the acrylate or methacrylate ester units that include the alkoxysilane functionality.
The polymerization can be initiated using a variety of methods, including without limitation thermal energy, ultraviolet light, and redox chemical reactions. A solution of the above ingredients can be added to an initiator solution at a temperature suitable for generating free radicals, for instance about 50 ° C to 90° C. An initiator can be prepared by dissolving an initiator in an organic or aqueous solvent. A suitable class of initiators are organic peroxides and azo compounds, with benzoyl peroxide and azobisisobutylnitrile (ABN) as examples.
Compounds containing an O-O, S-S, or N==N bond can be used as thermal initiators. Compounds containing 0-0 bonds; i.e., peroxides, are commonly used as initiators for polymerization. Such commonly used peroxide initiators include: alkyl, dialkyl, diaryl and arylalkyl peroxides such as cumyl peroxide, t-butyl peroxide, di-t-butyl peroxide, dicumyl peroxide, cumyl butyl peroxide, 1 ,1 -di-t-butyl peroxy-3,5,5-trimethylcyclohexane, 2,5-dimethyl-2,5-di(t-butylperoxy)hexane, 2,5-dimethyl-2,5-bis(t-butylperoxy)hexyne-3 and bis(a-t-butyl peroxyisopropylbenzene); acyl peroxides such as acetyl peroxides and benzoyl peroxides; hydroperoxides such as cumyl hydroperoxide, t-butyl hydroperoxide, p-methane hydroperoxide, pinane hydroperoxide and cumene hydroperoxide; peresters or
peroxyesters such as t-butyl peroxypivalate, t-butyl peroctoate, t-butyl perbenzoate, 2,5- dimethylhexyl-2,5-di(perbenzoate) and t-butyl di(perphthalate); alkylsulfonyl peroxides; dialkyl peroxymonocarbonates; dialkyl peroxydicarbonates; diperoxyketals; ketone peroxides such as cyclohexanone peroxide and methyl ethyl ketone peroxide. Additionally, azo compounds such as 2,2'-azobisisobutyronitrile abbreviated as AIBN, 2,2'-azobis(2,4- dimethylpentanenitrile) and 1 ,1 '-azobis(cyclohexanecarbonitrile) can be used as the initiator.
In one aspect, the flexible absorbent binder is made by combining a first aqueous monomer solution including a reducing polymerization initiator with a second aqueous monomer solution including an oxidizing polymerization initiator, wherein the initiators react to form a binder coating. The first aqueous monomer solution further includes a
monoethylenically unsaturated monomer and an ethylenically unsaturated monomer that contains an alkoxysilane functionality. The second aqueous monomer solution includes a monoethylenically unsaturated monomer. One or both solutions can include the polyolefin glycol and/or polyolefin oxide template polymer. Suitably, the binder coating is formed in about 100 minutes or less, or 60 minutes or less, desirably in about 30 minutes or less, or about 15 minutes or less, or about 10 minutes or less.
The pH of the first and/or second aqueous monomer solution is adjusted to about
4.5 to 8, suitably about 5.5 to about 7.0. The pH of the first aqueous solution can be adjusted prior to the addition of the ethylenically unsaturated monomer. Desirably, the pH of the first aqueous monomer solution is adjusted prior to the addition of the reducing polymerization initiator. The pH of the second aqueous solution can be adjusted prior to the addition of the oxidizing polymerization initiator. Alternatively, the pH of the combined first and second aqueous monomer solutions can be adjusted to about 4.5 to 8, suitably about 5.5 to about 7.0. If desired, the pH can be increased after polymerization is complete, by addition of a suitable basic solution. The extent of neutralization can be used to adjust the properties of the binder. Greater neutralization of the acid functional components generally provides for greater absorbent capacity, while adhesiveness is generally enhanced with more acid functionality. The amounts of the polymerization ingredients added to the first and second aqueous solutions are selected so as to produce the flexible absorbent binder having the binder described above.
In one aspect, a surfactant can be added to the first and/or second aqueous monomer solution to disperse the ethylenically unsaturated monomer. One surfactant suitable for use in the present disclosure is a dioctyl sodium sulfosuccinate available under the trademark AEROSOL OT from Cytec Industries, Inc. of Paterson, N.J.
The first aqueous monomer solution further includes a reducing polymerization initiator. Suitable reducing polymerization initiators include, but are not limited to, ascorbic acid, alkali metal sulfites, alkali metal bisulfites, ammonium sulfite, ammonium bisulfite, alkali metal hydrogen sulfite, ferrous metal salts such as ferrous sulfates, sugars, aldehydes, primary and secondary alcohols, and combinations thereof. In one aspect, the reducing polymerization initiator includes ascorbic acid.
The second aqueous monomer solution further includes an oxidizing polymerization initiator. Suitable oxidizing initiators include, but are not limited to, hydrogen peroxide, alkali metal persulfates, ammonium persulfate, alkylhydroperoxides, peresters, diacryl peroxides, silver salts, and combinations thereof. In one aspect, the oxidizing polymerization initiator includes hydrogen peroxide.
Generally, when the first aqueous monomer solution is combined with the second aqueous monomer solution the reducing polymerization initiator reacts with the oxidizing polymerization initiator, e.g. a redox reaction, thereby initiating a polymerization reaction to form a binder coating including a monoethylenically unsaturated monomer and an ethylenically unsaturated monomer that has post-application, moisture-induced crosslinking capability.
EXAMPLE
Standard paper towels were cut into strips and compressed, but were left untreated as a control. Other paper towels were treated with flexible absorbent binder (FAB, 1 12% add-on), dried, and cut into strips. These strips were then folded and compressed (to 3K, 5K, 8K lbs.) in a circular compression mold to produce compressed disks. Thus, two sample types were produced as illustrated in Fig. 6A: compressed, untreated paper strips (top row), and compressed, treated paper disks (numbered disks in bottom row). 1 g of blood (from calf liver) was placed in small beakers (10ml) to mimic a traumatic puncture wound such as a bullet hole (see Fig. 6B). The strips and the disks were also placed in the small beakers (see Fig. 6C, control on left). After five minutes, the control compressed paper absorbed the blood but distorted to leave gaps (see Figs. 6D-6F). The FAB/paper disk sample absorbed the blood, swelled, and plugged the hole (see Figs. 6D-6F). Figs. 6E and 6F illustrate the level of sealing, showing the small beakers on their sides and inverted.
In a first particular aspect, a wound care device includes an elongated body having a proximal end and a distal end, wherein the body includes compressed material treated with a flexible absorbent binder.
A second particular aspect includes the first particular aspect, wherein the body is an assembly of compressed elements, and wherein at least one of the elements includes compressed material treated with a flexible absorbent binder.
A third particular aspect includes the first particular aspect and/or the second particular aspect, wherein the body includes an elongate portion and a ring portion.
A fourth particular aspect includes one or more of aspects 1 -3, wherein the body has a shape prior to compression, wherein the shape includes multiple planes and multiple angles.
A fifth particular aspect includes one or more of aspects 1 -4, wherein the
compressed material has a level of compression, and wherein the level of compression varies from the distal end to the proximal end.
A sixth particular aspect includes one or more of aspects 1 -5, wherein the body includes a first split in the distal end.
A seventh particular aspect includes one or more of aspects 1 -6, wherein the body includes a second split in the distal end.
An eighth particular aspect includes one or more of aspects 1 -7, wherein the body includes an additive having a concentration, and wherein the concentration of the additive varies from the distal end to the proximal end.
A ninth particular aspect includes one or more of aspects 1 -8, further comprising a sheath at least partially enveloping the body.
A tenth particular aspect includes one or more of aspects 1 -9, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film.
An eleventh particular aspect includes one or more of aspects 1 -10, wherein the body comprises a plurality of compressed absorbent elements.
A twelfth particular aspect includes one or more of aspects 1 -1 1 , wherein the flexible absorbent binder is an oligomeric pre-superabsorbent including a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate ester units; the copolymer establishes intimate contact with the substrate; the copolymer crosslinks after establishing intimate contact with the substrate; the copolymer assumes a final shape on the substrate to form the binder; and the binder absorbs water vapor at 22° C. and 50% relative humidity at a rate of at least 4 weight percent per hour, for at least two hours.
A thirteenth particular aspect includes one or more of aspects 1 -12, wherein the compressed material includes one or more of a woven material, a nonwoven material, a foam material, and a film.
A fourteenth particular aspect includes one or more of aspects 1 -13, wherein the body further comprises a wound healing agent.
A fifteenth particular aspect includes one or more of aspects 1 -14, wherein the body further comprises a distal zone and a proximal zone.
A sixteenth particular aspect includes one or more of aspects 1 -15, wherein the distal zone and the proximal zone differ in one or more of their material, chemical, physical, and additive properties.
A seventeenth particular aspect includes one or more of aspects 1 -16, wherein the compressed material includes paper.
In an eighteenth particular aspect, wound care device includes an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes one or more of a woven material, a nonwoven material, a foam material, and a film ; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements.
A nineteenth particular aspect includes the eighteenth particular aspect, wherein the compressed absorbent elements differ in one or more of their material, chemical, physical, and additive properties.
In a twentieth particular aspect, wound care device includes an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes paper; a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and a flexible absorbent binder treatment on at least one of the compressed absorbent elements, wherein the flexible absorbent binder includes a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate ester units; the copolymer establishes intimate contact with the substrate; the copolymer crosslinks after establishing intimate contact with the substrate; the copolymer assumes a final shape on the substrate to form the binder; and the binder absorbs water vapor at 22° C. and 50% relative humidity at a rate of at least 4 weight percent per hour, for at least two hours.
While the disclosure has been described in detail with respect to the specific aspects thereof, it will be appreciated that those skilled in the art, upon attaining an understanding of the foregoing, can readily conceive of alterations to, variations of, and equivalents to these aspects. Accordingly, the scope of the present disclosure should be assessed as that of the appended claims and any equivalents thereto.

Claims

WHAT IS CLAIMED IS:
1 . A wound care device comprising:
an elongated body having a proximal end and a distal end, wherein the body includes compressed material treated with a flexible absorbent binder.
2. The wound care device of claim 1 , wherein the body is an assembly of compressed elements, and wherein at least one of the elements includes compressed material treated with a flexible absorbent binder.
3. The wound care device of claim 1 , wherein the body includes an elongate portion and a ring portion.
4. The wound care device of claim 1 , wherein the body has a shape prior to compression, wherein the shape includes multiple planes and multiple angles.
5. The wound care device of claim 1 , wherein the compressed material has a level of compression, and wherein the level of compression varies from the distal end to the proximal end.
6. The wound care device of claim 1 , wherein the body includes a first split in the distal end.
7. The wound care device of claim 6, wherein the body includes a second split in the distal end.
8. The wound care device of claim 1 , wherein the body includes an additive having a concentration, and wherein the concentration of the additive varies from the distal end to the proximal end.
9. The wound care device of claim 1 , further comprising a sheath at least partially enveloping the body.
10. The wound care device of claim 9, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film.
1 1 . The wound care device of claim 1 , wherein the body comprises a plurality of compressed absorbent elements.
12. The wound care device of claim 1 , wherein the flexible absorbent binder is an oligomeric pre-superabsorbent including a reaction product of about 15%-99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate ester units; the copolymer establishes intimate contact with the substrate; the copolymer crosslinks after establishing intimate contact with the substrate; the copolymer assumes a final shape on the substrate to form the binder; and the binder absorbs water vapor at 22 ° C. and 50% relative humidity at a rate of at least 4 weight percent per hour, for at least two hours.
13. The wound care device of claim 1 , wherein the compressed material includes one or more of a woven material, a nonwoven material, a foam material, and a film.
14. The wound care device of claim 1 , wherein the body further comprises a wound healing agent.
15. The wound care device of claim 1 , wherein the body further comprises a distal zone and a proximal zone.
16. The wound care device of claim 15, wherein the distal zone and the proximal zone differ in one or more of their material, chemical, physical, and additive properties.
17. The wound care device of claim 1 , wherein the compressed material includes paper.
18. A wound care device comprising:
an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes one or more of a woven material, a nonwoven material, a foam material, and a film ;
a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and
a flexible absorbent binder treatment on at least one of the compressed absorbent elements.
19. The wound care device of claim 18, wherein the compressed absorbent elements differ in one or more of their material, chemical, physical, and additive properties.
20. A wound care device comprising:
an elongated body having a proximal end and a distal end, wherein the body comprises a plurality of compressed absorbent elements, wherein each compressed absorbent element includes paper;
a sheath at least partially enveloping the body, wherein the sheath includes one or more of a woven material, a nonwoven material, a foam material, and a film; and
a flexible absorbent binder treatment on at least one of the compressed absorbent elements, wherein the flexible absorbent binder includes a reaction product of about 15%- 99.8% by mass of monoethylenically unsaturated units; about 0.1 %-20% by mass polyacrylate ester units that include an alkoxysilane functionality; and about 0.1 %-75% by mass polymer units selected from polyolefin glycol units, polyolefin oxide units, or combinations thereof; wherein the reaction product includes a copolymer of at least the monoethylenically unsaturated units and the polyacrylate ester units; the copolymer establishes intimate contact with the substrate; the copolymer crosslinks after establishing intimate contact with the substrate; the copolymer assumes a final shape on the substrate to form the binder; and the binder absorbs water vapor at 22 ° C. and 50% relative humidity at a rate of at least 4 weight percent per hour, for at least two hours.
PCT/US2016/048032 2015-08-31 2016-08-22 Products for sealing wounds using compressed materials and flexible absorbent binders Ceased WO2017040091A1 (en)

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US201562212102P 2015-08-31 2015-08-31
US62/212,102 2015-08-31
US201562247822P 2015-10-29 2015-10-29
US62/247,822 2015-10-29

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5578317A (en) * 1995-03-31 1996-11-26 Mulder; Gerit D. Wound filler and method of manufacture
US6191341B1 (en) * 1998-04-21 2001-02-20 Ronald D. Shippert Medical absorbent pack substantially free of unwanted adhesion properties
US7115321B2 (en) * 2002-07-26 2006-10-03 Kimberly-Clark Worldwide, Inc. Absorbent binder coating
US20060247592A1 (en) * 2005-04-29 2006-11-02 Schmidt-Forst Alexander Dual mode absorbent tampon
WO2011077145A1 (en) * 2009-12-21 2011-06-30 Smith & Nephew Plc Hemostatic device for administration to a wound cavity

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5578317A (en) * 1995-03-31 1996-11-26 Mulder; Gerit D. Wound filler and method of manufacture
US6191341B1 (en) * 1998-04-21 2001-02-20 Ronald D. Shippert Medical absorbent pack substantially free of unwanted adhesion properties
US7115321B2 (en) * 2002-07-26 2006-10-03 Kimberly-Clark Worldwide, Inc. Absorbent binder coating
US20060247592A1 (en) * 2005-04-29 2006-11-02 Schmidt-Forst Alexander Dual mode absorbent tampon
WO2011077145A1 (en) * 2009-12-21 2011-06-30 Smith & Nephew Plc Hemostatic device for administration to a wound cavity

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