WO2003092756A1 - Multi-layer synthetic dressing with cooling characteristics - Google Patents
Multi-layer synthetic dressing with cooling characteristics Download PDFInfo
- Publication number
- WO2003092756A1 WO2003092756A1 PCT/CA2003/000630 CA0300630W WO03092756A1 WO 2003092756 A1 WO2003092756 A1 WO 2003092756A1 CA 0300630 W CA0300630 W CA 0300630W WO 03092756 A1 WO03092756 A1 WO 03092756A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- dressing
- layer
- set forth
- mixture
- hydrophilic
- Prior art date
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- 239000004945 silicone rubber Substances 0.000 description 1
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- 230000000087 stabilizing effect Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/022—Adhesive bandages or dressings with fluid retention members having more than one layer with different fluid retention characteristics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
- A61F13/0289—Apparatus or processes for manufacturing adhesive dressings or bandages manufacturing of adhesive dressings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/425—Porous materials, e.g. foams or sponges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00089—Wound bandages
- A61F2013/00187—Wound bandages insulating; warmth or cold applying
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00089—Wound bandages
- A61F2013/00217—Wound bandages not adhering to the wound
- A61F2013/00229—Wound bandages not adhering to the wound with alginate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00655—Plasters adhesive
- A61F2013/00676—Plasters adhesive hydrogel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00727—Plasters means for wound humidity control
- A61F2013/00731—Plasters means for wound humidity control with absorbing pads
- A61F2013/0074—Plasters means for wound humidity control with absorbing pads containing foams
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00727—Plasters means for wound humidity control
- A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00902—Plasters containing means
- A61F2013/00927—Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
- A61F2013/00931—Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors chitin
Definitions
- the present invention relates to wound dressings with improved characteristics.
- This invention is directed to an absorbent, synthetic pad particularly suited for use as a dressing. More particularly, one embodiment of the present invention relates to a polyurethane-based dressing made up of at least two layers, the surface- contacting layer possessing particular cooling characteristics.
- the dressing comprises one layer of hydrophilic polyurethane foam, preferably HYPOL polyurethane, and at least one surface-contacting layer of hydrogel, preferably HYPOL hydrogel.
- the hydrophilic layer functions as a reservoir capable of absorbing excess exudates, while the hydrogel layer acts as a minimally adherent surface that maintains the wound bed adequately moist to promote optimal wound healing, and exerts a soothing, cooling effect.
- the latter hydrogel layer may require perforation for purposes of fluid passage to the adjoining layer.
- Wound care constitutes an important aspect of wound healing and can play an integral role in post-operative treatment. Wound care regimens have changed considerably over the last three decades, through a better understanding of the physiological mechanisms underlying wound healing. This knowledge has led to the development of many types of wound dressings, all claimed to be useful for healing wounds. While many commercially available wound dressings are stated to be low- adherent wound dressings, they have a tendency to dry. Unless these dressings are frequently changed, they become incorporated into the newly formed granulation tissue, thus causing undesirable damage to a healing wound site upon removal. The absorbency capacity of many known dressings is minimal, thus limiting their use primarily to wounds with low exudates.
- An ideal wound dressing should be highly absorbent to wound exudates, minimally adherent to the wound bed to reduce the risk of re-injury upon removal of the dressing and exert a soothing and/or cooling effect upon application to the wound, especially a burn wound.
- the wound dressing of the present invention was created to overcome the shortcomings of conventional wound dressings.
- a dressing with these characteristics may also be used for cosmetic, dental or therapeutic applications.
- Hydrogels are important wound care products with a unique ability to maintain the wound bed moist, and to cool the surface on which they are applied.
- a distinct disadvantage of commercially available hydrogel wound dressings is that they typically contain a high water content (>90%). This characteristic significantly restricts their absorbency capacity and a secondary dressing is usually required to absorb any excess wound exudate.
- polyurethane wound dressings are therefore important wound care products, especially since they can absorb moderate to high volumes of wound exudate.
- the patent literature is also replete with references to multi-layer polyurethane wound dressings (preferably made of HYPOL polyurethane) in which therapeutic substances may be incorporated.
- the layers of the multi-layered polyurethane dressing comprise a polyurethane layer and a hydrogel layer directly in contact with the skin or the wound, as disclosed in the wound dressing of the present invention.
- the multi-layer dressing according to the present invention has no adhesive layer on the contact face of the dressing, but has a minimally adherent HYPOL hydrogel or any other suitable hydrogel as the surface-contacting layer.
- the surface-contacting HYPOL hydrogel layer has a high water content to promote cooling upon application to a surface of a host such as a vertebrate host and to reduce adhesion of the dressing to the wound surface.
- the layers of the subject dressing comprise HYPOL of different physical/chemical characteristics.
- the present invention provides a dressing, comprising an optional outer layer of either hydrogel or elastomeric material; a hydrophilic polymer foam layer; a surface-contacting layer comprised of hydrogel and an optional protective release sheet.
- the optional release sheet is divided into two separable, overlapping portions.
- the ready-to-use dressings are sealed in pouches that are preferably impermeable to water vapor and the packaged unit can be sterilized (e.g., by gamma -irradiation).
- the present invention comprises a dressing having at least two primary layers.
- the first primary layer is preferably composed of HYPOL polyurethane foam pre-polymer, or another similar hydrophilic polyurethane pre-polymer (hereinafter, hydrophilic polyurethane pre-polymers will be referred to generically as HYPOL), which serves as a fluid-retention reservoir.
- HYPOL hydrophilic polyurethane pre-polymers
- the second primary layer is a minimally adherent surface-contacting layer, and preferably composed of HYPOL hydrogel or any other suitable hydrogel.
- the surface- contacting hydrogel layer may require to be discontinuous or perforated to enhance fluid absorption.
- the first primary HYPOL fluid-reservoir foam layer can be sandwiched between two surface-contacting or "face" layers of HYPOL hydrogel (or any other suitable hydrogel), for use as a packing material in deep wounds or body cavities.
- Each of the layers of HYPOL (i.e., surface-contacting and HYPOL layers) in the dressing may have different physical/chemical characteristics. The formulation of the different HYPOL layers, which defines their physico- chemical characteristics, is determined by the functional role of each layer.
- the surface-contacting HYPOL hydrogel layer has a higher water content to promote cooling upon its being applied to a surface of a host such as a vertebrate host, and to reduce adhesion of the dressing to the wound surface.
- the hydrophilic foam layer has a physico-chemical composition, made up of HYPOL and possibly other blending agents, which promote the absorption of fluid and may potentially favor the release of entrapped therapeutic agents.
- a HYPOL layer that serves the primary function of removing and retaining wound exudate fluid requires a physico- chemical characteristic that promotes moisture take-up and retention.
- the initial moisture level of the hydrophilic HYPOL fluid-reservoir foam layer can be altered to affect the cooling capacity of the surface- contacting HYPOL hydrogel layer.
- a self-regulating, flow-sensitive polymeric or synthetic membrane is placed between the hydrophilic HYPOL layer and the hydrogel layer, with the intent that the membrane prevents passive moisture transfer from the hydrogel layer to the HYPOL layer, thereby prolonging the cooling properties of the hydrogel layer. The presence of a moderate to high flow of exudate triggers the physical modification of the membrane to facilitate moisture transfer to the fluid-retaining HYPOL foam layer.
- the use of HYPOL polyurethane pre-polymers enables the use of an existing known chemical process intrinsic to polyurethane polymers to cure the two layers together, thereby avoiding but not necessarily excluding in future developments the use of existing known processes (e.g., heat sealing, welding by radio frequency welding, ultrasonic welding, adhesives) to laminate such layers together. It is an object of this invention to provide a method for treating external wounds using a polyurethane foam dressing (preferably HYPOL polyurethane) comprised of at least two layers.
- Yet another object of the invention is to provide a method for treating external wounds, using a multi-layer polyurethane foam dressing (preferably HYPOL polyurethane) that has a minimally adherent surface-contacting layer that will provide immediate cooling to the surface to which it is applied, and has a fluid- retaining layer that will thereafter absorb excess exudates.
- a multi-layer polyurethane foam dressing preferably HYPOL polyurethane
- the safe time, over which a dressing of the present invention may remain in a body cavity or wound, will vary depending on the type of wound, the immediate condition of the site and the form of any other treatment which may be given to the wound.
- the dressing of the present invention is particularly useful as a wound dressing applied to external injuries such as abrasions, incisions, punctures, lacerations, ulcers, sores, burns and the like to aid in stopping bleeding, and in preventing and treating wound contaminations.
- the present invention relates to oral applications of the dressing of the present invention, for treatment of oral mucosal surfaces, including wounds.
- the present invention relates to treatment of internal tissues, including nasal, aural, rectal, peritoneal, or vaginal surfaces.
- the present invention relates to applying the dressing of the present invention to a wound.
- a dressing preferably comprised of HYPOL polyurethane
- a soft and flexible structure that is easy to handle and apply to a wound surface, without risking contamination of the dressing and/or wound site; is minimally adherent to reduce wound pain and to minimize or avoid re-injuring the wound site upon removal; and, provides a cooling effect upon application.
- Another object of the invention is to provide a method for making the non- medicated multi-layered polyurethane cooling dressing of the present invention.
- the present invention relates to a method of therapeutically or cosmetically treating the skin by application of the dressing of the present invention.
- Figure 1A is a perspective view of a first embodiment dressing in accordance with the present invention, having two polyurethane layers;
- Figure 1 B is a cross-sectional view of a portion of the Figure 1 A embodiment
- Figure 2A is a perspective view of a second embodiment dressing in accordance with the present invention, having three polyurethane layers;
- Figure 2B is a cross-sectional view of a portion of the Figure 2A embodiment
- Figure 3A is a perspective view of a third embodiment dressing in accordance with the present invention, having three polyurethane layers and an elastomeric attachment layer;
- Figure 3B is a cross-sectional view of a portion of the Figure 3A embodiment
- Figure 4 is a graphical representation comparing the cooling efficacy of the subject dressing applied on intact human skin to that of commercially available dressings
- Figure 5 is a graphical representation comparing the cooling efficacy of the subject dressing applied on rat burn wounds to that of commercially available dressings.
- a dressing 10 as a first embodiment of the present invention, has a layer 12 of polyurethane foam, preferably the aforementioned HYPOL.
- the layer 12 may constitute a reservoir for a selected drug or other therapeutic agent, represented by the elements 14 and 16.
- the layer 12 is adhered to a hydrogel polymer layer 17, which may contain at least one drug (not shown).
- the outer (lower) face of the layer 17 is protected by a two-piece cover- sheet 18, well known in the art, and having a pair of pull-tabs 19, to facilitate removal of the cover-sheet 18.
- the protective cover-sheet 18 is removed from the dressing 10, and the outer hydrogel layer 17 is applied to the injured surface.
- the cover-sheet 18 preserves the sterility of the subject invention, and sustains the hydration of the hydrogel layer 17.
- the dressing 10 may be secured in place by way of a secondary dressing such as a bandage, tubular dressing, etc. (not shown).
- the form of the dressing 10 may be of cylindrical shape, for use as a packing within a deep wound, or a body cavity, where a fastening means is not usually required.
- the first embodiment of the subject dressing may also be used as a minimally adherent containment device for spilled internal organs.
- a dressing 20, representative of a second embodiment of the present invention has a fluid-retaining layer 12 comprised of a hydrophilic polyurethane foam layer, being illustrated as having two drugs 14, 16 in dispersed relation therein; the layer 12 being cast, as disclosed herein, over a surface- contacting hydrogel polymer layer 17, which may contain at least one drug therein (not shown), and is protected by a cover sheet 18.
- a second hydrogel polymer layer 17, which also may contain at least one drug therein, is cast in adhering relation on top of the drug reservoir layer 12. This top layer 17 also may be protected by a cover-sheet 18 (not shown).
- the second embodiment multi-layered dressing 20 (after removal of both portions of the cover-sheet 18) may be used as a packing material for internal wounds, such as peritoneal wounds or nasal wounds, and thus does not require further means of attachment to the patient other than what is dictated by conventional surgical procedures.
- the bi- layer dressing 30 has a fluid-retaining layer 12 comprising a hydrophilic polyurethane foam layer being illustrated as having two drugs 14, 16 in dispersed relation therein.
- This layer 12 is cast as disclosed herein over a wound surface-contacting layer 17 comprised of a hydrogel polymer, the layer 17 also containing at least one drug (not shown).
- An adhesive outer elastomeric layer 34 extending beyond the edges of the layer 12 and providing a means of attachment to the patient, completes the dressing 30 as a bi-layer wound dressing.
- the two adhesive under-surfaces of the layer 34 and the hydrogel layer 17 are each protected by a respective cover-sheet 18.
- the third embodiment of a multi-layered drug delivery device 30 can be used as a band-aid for superficial wounds or as a compression bandage for hemorrhagic penetrating wounds.
- the elastomeric adhesive outer layer 34 is selected from a group of materials including, but not limited to polyurethane, polyethylene, vinyl, polyvinylchloride, or other suitable material.
- the elastomeric outer layer 34 is water-vapour and gas- permeable; substantially liquid-impermeable to prevent leakage of wound exudates from the dressing; and is also microbe-impermeable.
- the perimeter portion of the elastomeric adhesive outer layer 34 is coated with a suitable medical-grade adhesive, and is preferably perforated to allow the skin of the patient to breathe.
- the outer layer 34 may be bonded to the foam layer 12 using conventional bonding methods (e.g., heat).
- This elastomeric adhesive outer layer 34 serves to secure the dressing to the patient and/or to apply adequate pressure to stop bleeding.
- the reactant mixture formulation of the HYPOL foam layer can be readily tailored to provide for application either as a 'band- aid' for superficial wounds (including scrapes, abrasions, donor sites), or as a compression bandage for hemorrhagic penetrating wounds.
- the third embodiment 30 does not require the use of a secondary dressing, but involves merely the removal of the cover sheet 18 prior to its application to the wound.
- the subject dressings can be manufactured to assume various shapes (cylindrical, oval, tubular, etc.) or flat sheets of various predetermined sizes.
- the dressings are prepared under aseptic conditions, packaged in aluminum foil laminated bags with a heat sealable film, and sterilized in the package. Favoured procedure is by gamma-sterilization.
- the dressing can be sterilized by ethylene oxide and heat sterilization.
- hydrophilic polymer foam means any foam that will absorb fluids such as water, blood, wound exudates (including blister fluid) and other body fluids (including peritoneal fluid).
- Appropriate hydrophilic foams include polyurethane; carboxylated butadiene- styrene rubber; polyacrylate; polyvinylic; polyester or cellulosic foams; polyurethane prepolymers derived from methylenediphenyl diisocyanate (MDI) or tolylene diisocyanate (TDI) prepolymers; or hydrophilic epoxy foams.
- Polyvinylic foams include polyvinyl acetal foams formed by the reaction of polyvinyl alcohol and an aldehyde.
- hydrophilic polyurethane foams are hydrophilic polyurethane foams, especially cross-linked polyurethane foams.
- HYPOL pre-polymer foams form a preferred group of foams within the general description of hydrophilic polymer foams.
- HYPOL foams can be made from HYPOL hydrophilic isocyanate terminated prepolymers marketed by DOW Chemicals Inc. Ideally, the hydrophilic foam will absorb at least four times its weight in fluids.
- Suitable foams may be prepared from hydrophilic materials per se or may be treated to render them hydrophilic (e.g., with surfactants, superabsorbent agents, etc.).
- the foam be highly hydrophilic per se, since the incorporation of chemicals (including surfactants, etc.) may alter the physical characteristics (e.g., absorption, porosity, pore size, etc.) of the foam material. It is also desirable that the hydrophilic polymer foam layer absorbs the wound exudate rapidly as this prevents undesirable maceration of the wound by the accumulation of exudates underneath the dressing.
- the hydrophilic foam used should also be conformable (i.e., soft and compressible, not stiff or rigid). That is, the hydrophilic foam, when placed in a body cavity, will conform readily to the contours of the wounds, whether the patient is resting or moving.
- the hydrophilic polyurethane foam may be comprised of a single type of polymer, although blends may be used to form the hydrophilic foam.
- polyurethane foam polymerized with polyether-polyamides; polyether polyurethane; polyvinyl alcohols; and mixtures thereof.
- the polyurethane hydrophilic foam may be cross-linked with chitin; collagen; fibrin; aliginate; glycosaminoglycan; polyvinyl-lactam such as polyvinylpyrrolidone, polyvinylbutirolactam, polyvinylcaprolactam and the like; cellulose derivatives; benzene-1 ,2,4-tricarboxylic acid; nit lotriacetic acid; citric acid; 4,4-methylenebis(o- chloroaniline); or mixtures thereof.
- Suitable polyols may be mixed with the polyurethane hydrophilic foam, and include, but are not restricted to, water soluble alcohols, including monols, diols and polyhydric alcohols. Examples of monols include ethyl alcohol and isopropyl alcohol.
- Suitable diols are propylene glycol, polyethylene glycol and polypropylene glycol.
- suitable polyhydric alcohols are glycerin, 1 ,2,4- butanetriol, trimethylolpropane, pentaerythritol and sorbitol.
- Suitable catalysts may also be added to the polyurethane hydrophilic foam to produce desirable physical characteristics.
- Such catalysts include, but are not restricted to, dimethylethanolamine; diethylenetriamine; triethylenetetramine; tetraethylenepentamine; polyethyleeneimine; glycerol; trimethylolpropane; pentaerythritol; tolylene-2,4,6-triamine; ethylene diamine; amino-ethanol; trimethylenediamine; tetramethylenediamine; pentamethylene-diamine; hexamethylene-diamine; ethanolamine; diethanolamine; hydrazine; triethanolamine; n-methyl morpholine; n-ethyl morpholine; trimethylamine; triethylamine; tetramethyl butane diamine; triethylene diamine; dimethylaminoethanoi; benzyldimethylamine; dibutyl tim dilaureate; and stannous octoate.
- Useful additives may also be added to the polyurethane foam, and include, but are not limited to, organic and inorganic salts; alcohols; amines; acids; polymer latices; resin or wax dispersions; fillers; fibers; cellulosics; surfactants; pigments; dyes; enzymes; proteins; chelates; thickeners; stabilizers; and so forth.
- the foam layer may contain a number of other chemicals described in detail herein, to further improve its hydrophilic properties. Surfactants may be included in this layer.
- Suitable and preferred biocompatible surfactants forming conformable hydrophilic polymer foams include, but are not limited to, non-ionic surfactants, such as oxypropylene-oxyethylene block co-polymers known as PluronicsTM marketed by BASF Wyandotte, preferably Pluronic F68 sorbitan trioleate; polyoxyethylene sorbitoi oleate; polyoxyethylene sorbitan monolaureate; polyoxyethylene lauryl ether; polyoxyethylene stearyl ether; fluorochemical surfactants; and block copolymer condensates of ethylene oxide and propylene oxide with propylene glycol; methylcellulose; guar gum; pectin; karaya gum; agar; acacia powder; gelatin; and other hydrophilic polymers and combinations thereof.
- non-ionic surfactants such as oxypropylene-oxyethylene block co-polymers known as PluronicsTM marketed by BASF Wyandotte, preferably Pluronic F68
- the amount of surfactant should be up to 10% by weight of the foam reactant mixture.
- the selected surfactant should not react with the selected pre-polymer, or with any component of the reactant mixture as to impair foam formation or to adversely affect the desired characteristics of the foam composition, in use or while being stored.
- the foam reactant composition may include a hydrophilic agent that is incorporated into the foam mixture to absorb liquid (e.g. wound exudate, peritoneal fluid).
- the hydrophilic agent is preferably a highly absorbent polymer, commonly known as a superabsorbent polymer. Inclusion of such agent will increase the capacity of the wound dressing to retain at least twice its weight in fluid after compression.
- the amount and type of hydrophilic agent used in the wound dressing will be governed by the intended application of the invention.
- a hydrophilic agent with a high uptake is desirable for an ulcerating wound with large fluid exudate volume (e.g., a burn or a bleeding wound).
- a hydrophilic agent with a high uptake is desirable for an ulcerating wound with large fluid exudate volume.
- a laceration or abrasion it may be more suitable to use a less hydrophilic agent or to use an agent with a lower fluid uptake. Determination of the types and amounts of adjuvant, surfactant and hydrophilic agent used is well within the ability and knowledge of one skilled in the art, in light of the disclosure contained herein.
- the surface-contacting hydrogel layer is preferably made of HYPOL, but may be made of any of the known hydrogels heretofore employed for wound treatment and already known to those skilled in the art.
- the hydrogel may be comprised of, or cross-linked with, polyvinyl alcohol; polyvinylpirrolydone; polyvinyl-lactam; collagen; dextran; cellulose; hyaluronate; chitin; chitosan; agar; agarose; alginate; carrageenan; silicone; polyurethane; polyethylene oxide-based diamine; gelatin; glycerine; polyoxamides; polyesters; polyoxaesters; vinyl esters polymers; vinyl carboxylic acids and salts; polyacrylamide; dimethylacrylamine co-polymers; or compatible mixtures thereof.
- the surface-contacting hydrogel layer may also comprise cryogels or other gels produced without the use of cross-linking agents or other adjuvants.
- the surface-contacting hydrogel layer may further include hydrogel-forming agents.
- hydrogel-forming agents For example, vinyl-cross-linked polyethylene oxides; polyurethane ureas; polysiloxanes; mixtures of gellable polysaccharides such as carboxymethyl cellulose, carboxymethyl starch and hydroxypropyl cellulose; proteins; hydrophilic polymers; graft polymers of hydrolyzed starch; polyacrylonitrile; nonionic agents such as polyvinyl alcohol, and polyvinyl ethers; cationic agents such as polyvinyl pyridine, polyvinyl morpholinione; and combinations thereof.
- hydrogel-forming agents for example, vinyl-cross-linked polyethylene oxides; polyurethane ureas; polysiloxanes; mixtures of gellable polysaccharides such as carboxymethyl cellulose, carboxymethyl starch and hydroxypropyl cellulose; proteins; hydrophilic polymers; graft polymers of hydrolyzed starch; polyacrylon
- the surface-contacting hydrogel layer may further include a number of other chemicals as described herein, to further improve its cooling characteristics.
- other chemicals for example, polypropylene glycol; propylene glycol; polyethylene glycol; dipropylene glycol; and the like.
- pre-polymer in the reactant mixture used to prepare each of the layers will depend on a number of factors, including the proportion of other components in the reactant mixture. In all instances, there should be sufficient pre-polymer and water to form a polyurethane foam or hydrogel layer of suitable thickness. There should also be sufficient pre-polymer to provide integrity to each of the layer compositions, but not so much that the resulting compositions become unworkable.
- the reactant mixtures of each layer of the subject dressings may further include an adjuvant to extend the curing time of the foam or hydrogel reactant mixture, thereby allowing a thorough mixing of the mixtures prior to spreading them sequentially into layers of suitable thickness, for curing.
- the adjuvant selected is water soluble and biocompatible (i.e., does not exert harmful effects upon contacting the wound bed or skin). It is also preferable that the selected adjuvant be compatible with the pre-polymers selected as well as with the therapeutic agents or other additives incorporated into the reactant mixtures.
- Suitable adjuvants include water soluble alcohols, including monols, diols, and polyhydric alcohols.
- the reactant foam or hydrogel mixtures should contain less than 0.01% of alcohol by weight.
- a first method of manufacture of the subject dressing consists of the steps of mixing the appropriate reactants of the surface-contacting hydrogel layer together in an appropriate receptacle to form a standardized aerated mix. The mixture is then spread at room temperature onto a smooth support to which it is not adherent (e.g., a glass surface) to form a layer of pre-determined thickness. The spreading may be effected by means of a spreader bar that is drawn over the surface of the mix at a fixed distance above the support surface.
- the second layer i.e., the hydrophilic foam layer
- a third layer comprising HYPOL hydrogel would be immediately cast on top of the hydrophilic polymer foam layer.
- the mixture of the surface-contacting hydrogel layer is spread as described herein over a fully cured hydrophilic foam layer.
- a third layer comprising HYPOL hydrogel is cast on top of the hydrophilic foam layer already in adhering relation to another surface- contacting hydrogel layer.
- the pre-polymers selected are preferably capable of curing in the absence of catalysts, and at ambient temperature.
- the surface-contacting hydrogel layer may be perforated or sliced through its thickness in several sites to create channels to enhance absorption of exudates.
- the mixture of the surface-contacting hydrogel layer is sprayed over a fully cured hydrophilic foam layer to form a discontinuous hydrogel layer, thus enhancing absorption of exudates into the hydrophilic polyurethane foam layer.
- the surface-contacting hydrogel layer will generally although not necessarily have a thickness of up to 2.54 mm, and preferably in the range 0.76 to 1.27 mm.
- the hydrophilic polymer foam layer will generally, although not necessarily, have a thickness of up to 10 mm, and preferably in the range of 3 to 7 mm. It will be appreciated by those skilled in the art that the thickness of the layers will depend, however, on a variety of considerations, including the quantity of each additive to be incorporated in each of the layers, the level of absorbency or cooling required, and the like.
- This first example describes how experimental dressings of the present invention were prepared under laboratory conditions.
- the two layers that comprised the dressing were prepared separately.
- the hydrogel layer was first cast onto a glass plate and within approximately 2 minutes, the foam-based second mixture was poured over it.
- the resulting dressings consisted of a hydrogel layer with a thickness of about 0.25 mm (10 mils) and a foam layer with a thickness of about 3.2 mm (128 mil).
- Process parameters e.g., reaction temperatures, mixing speeds and mixing times
- the hydrogel layer was prepared as follows. Water was added to a mixture consisting of the pre-polymers Hypol 2060G and Hypol G50 (72% + 0.4 w/w) at a
- the aqueous dispersion was mixed at 800 + 100 rpm for 30 seconds.
- the solution was poured onto a glass plate (30 cm x 30 cm) between two borders (10 cm apart).
- the borders were made of a ultra high molecular weight polyethylene (UHMWPE) tape (10 mils thick) with an acrylic adhesive backing.
- UHMWPE ultra high molecular weight polyethylene
- the aqueous mixture was then spread between the borders using a glass plate covered with a 3 mils thick silicone adhesive polytetrafluoroethylene (PTFE) tape.
- the solution was spread in one direction followed by a second spreading pass in the opposite direction.
- the hydrogel layer was allowed to set for 2 minutes prior to pouring the foam layer over it.
- the hydrogel layer needed to have almost set-up prior to pouring the second, foam-based solution over it; otherwise a non-set hydrogel could be displaced by the second solution, and a non-uniform hydrogel layer would result.
- the foam layer was prepared during the casting of the hydrogel layer. Chilled water was added to pre-weighed Hypol 2002 pre-polymer at a ratio of approximately 1 .5:1 , and the solution was mixed at 3000 ⁇ 200 rpm for 30 seconds. After mixing, the solution was poured over the hydrogel layer between two silicone rubber borders (3.2 mm thick) placed on top of the UHMWPE tape borders used in casting the hydrogel layer. The foam solution was spread slowly in one direction followed by a second spreader pass in the opposite direction.
- EXAMPLE 2 -TEST STUDY (Reference Fig. 4) The objective of this study was to compare the effectiveness of various non- medicated dressings in cooling intact human skin.
- the skin over the triceps of both arms of eight subjects was cleansed using alcohol swabs.
- Two small thermistors were taped 5 cm apart on the skin of each arm, the probes being positioned approximately 10 cm from the tip of the shoulder.
- the four experimental groups of dressings tested were: a non-medicated dressing of the present invention as well as three commercially available wound-care products comprising: a hydrogel sheet, a polyurethane foam dressing, and an amorphous gel dressing.
- T S kin markedly dropped (3.0°C) within 10 min of applying the amorphous gel
- T Sk i n under the dressing of the present invention dropped by 1.0°C.
- the greater cooling effect of the gel dressing was short-lived, T S i n after 30 min being comparable to that observed for the dressing of the present invention.
- T s kin remained constant (29.2°C) under the dressing of the present invention for most of the 6-hour study, it increased steadily under the amorphous gel, reaching a plateau of 30°C after 90 min.
- the objective of this study was to compare the effectiveness of various non- medicated dressings in cooling a burn wound. Rats were anesthetized, and a 30% full-thickness scald wound was made on their dorsum. Three small thermistors were taped 1.5 cm apart on the dorsal skin, the first probe being positioned approximately 2 cm from the nape of the neck.
- the three experimental groups of dressings tested were: a non-medicated dressing of the present invention as well as two commercially available wound-care products comprising: a hydrogel sheet and a polyurethane foam dressing. A control group of animals was included to measure the temperature of the skin when no dressing was applied other than the securing wrap.
- the foam layer of the wound dressing of the present invention was wetted prior to its application to the burn wound with a volume of warm saline corresponding to 50% of the dressing's maximal absorption capacity, to provide an estimate of the cooling efficacy of a 'wet dressing' under a simulated a condition of moderate to high level of wound exudates.
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Abstract
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AU2003221580A AU2003221580A1 (en) | 2002-04-30 | 2003-04-30 | Multi-layer synthetic dressing with cooling characteristics |
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US37622902P | 2002-04-30 | 2002-04-30 | |
US60/376,229 | 2002-04-30 |
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WO2003092756A1 true WO2003092756A1 (en) | 2003-11-13 |
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WO2006100561A1 (en) * | 2005-03-22 | 2006-09-28 | Emilio Bottini | Multi-ply technical composite which is breathable and moisturising, releases active constituents and promotes their absorption, and can be used as a medical aid or to make clothing or structures that come into direct contact with healthy or diseased skin |
WO2007113453A1 (en) * | 2006-04-03 | 2007-10-11 | First Water Limited | Absorbent hydrogel composites |
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