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WO2003011352A1 - Materiau feuille a ouvertures, a base de composition d'hydrogel - Google Patents

Materiau feuille a ouvertures, a base de composition d'hydrogel Download PDF

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Publication number
WO2003011352A1
WO2003011352A1 PCT/GB2002/003406 GB0203406W WO03011352A1 WO 2003011352 A1 WO2003011352 A1 WO 2003011352A1 GB 0203406 W GB0203406 W GB 0203406W WO 03011352 A1 WO03011352 A1 WO 03011352A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheet
apertured
hydrogel
gels
apertured sheet
Prior art date
Application number
PCT/GB2002/003406
Other languages
English (en)
Inventor
Breda Mary Cullen
Andrew James Kirkwood
Original Assignee
Johson & Johson Medical Limited
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 Johson & Johson Medical Limited filed Critical Johson & Johson Medical Limited
Priority to EP02745682A priority Critical patent/EP1409030A1/fr
Priority to JP2003516582A priority patent/JP2004536670A/ja
Publication of WO2003011352A1 publication Critical patent/WO2003011352A1/fr

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Classifications

    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
    • B32B3/26—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
    • B32B3/266—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
    • 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
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/18—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by features of a layer of foamed material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • 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
    • A61F2013/00089—Wound bandages
    • A61F2013/00246—Wound bandages in a special way pervious to air or vapours
    • A61F2013/00251—Wound bandages in a special way pervious to air or vapours with macroscopic openings
    • 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
    • A61F2013/00365—Plasters use
    • A61F2013/00519—Plasters use for treating burn
    • 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
    • A61F2013/00855—Plasters pervious to air or vapours
    • A61F2013/00859—Plasters pervious to air or vapours with macroscopic openings
    • 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
    • A61F2013/00897—Plasters package for individual plaster
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/726—Permeability to liquids, absorption
    • B32B2307/7265—Non-permeable
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter

Definitions

  • the present invention relates to apertured, water-swellable sheet materials and to wound dressings comprising such sheet materials.
  • EP-A-0123465 describes the use in surgical dressings of continuous polymer films formed from materials that have a higher moisture vapor permeability when the film is wet than when the film is dry.
  • EP-A-0875222 describes wound dressings comprising a non-swelling, water- impermeable apertured sheet having slits cut therein, wherein the apertured sheet is laminated to a water swellable foam layer. Absorption of wound fluid causes the foam layer to swell, and the resulting deformation opens the slits in the apertured sheet thereby increasing the liquid permeability of the apertured sheet.
  • EP-A-0122085 describes wound dressings having a apertured sheet of water swellable material laminated to a less water-swellable layer. Slits are cut in the apertured sheet. In use, differential swelling of the apertured sheet and the underlying layer causes the slits in the apertured sheet to open, thereby increasing the permeability of the apertured sheet to wound fluid.
  • US-A-5352508 describes an apertured substrate web coated with a hydrogel material for use in wound dressings.
  • the present invention provides a self-supporting apertured sheet consisting essentially of a water-swellable hydrogel composition, wherein the apertures make up less than 50% of the area of the sheet before swelling.
  • the apertures make up from about 0.1% to about 50% of the area of the sheet (preferably of the wound facing area of the sheet) before swelling, more typically from about 1 % to about 30% of the area of the sheet before swelling, preferably from about 10% to about 25%, and more preferably from about 10% to about 20%. of the area of the sheet before swelling.
  • the apertured hydrogel sheet enables a moist wound environment to be maintained for prolonged periods, over a wide range of wound exudation rates.
  • the exudation rate is high, the apertured sheet expands and the resulting increase in the size of the apertures increases their liquid permeablility.
  • the sheet is thereby able to wick away wound fluid to prevent excessive moisture in the wound without removal of the hydrogel or blocking of the apertures in the hydrogel.
  • the hydrogel sheet shrinks and the resulting drop in liquid permeability helps to retain wound fluid at the surface of the wound.
  • the hydrogel absorbs moisture vapor and functions as a humectant to preserve a moist wound contacting surface.
  • the area of the apertures is increased by at least about 25%, for example at least about 50% by swelling the sheet in water at 25°C for 60 minutes.
  • the sheet has from about 1 to about 30 apertures per square cm, for example from about 4 to about 15 apertures per square cm or from about 5 to about 10 apertures per square cm.
  • the apertures are uniformly distributed over the surface of the sheet, preferably in a regular pattern.
  • the apertures are preferably small, since this results in the greatest proportional increase in liquid permeability when the hydrogel sheet swells.
  • the mean area of each aperture may be from about 0.01 to about 10 mm 2 , preferably from about 0.1 to about 4 mm 2 , and more preferably from about 1 mm 2 to about 2 mm 2 .
  • the apertures may have any suitable shape, as long as the size of the apertures increases when the hydrogel swells so as to increase the liquid permeability.
  • the apertures before swelling have a ratio of maximum length to maximum width of from about 1 to about 10, preferably from about 1 to about 3, and more preferably from about 1 to about 1.5.
  • Suitable aperture shapes include round, oval or regular polygonal
  • the cross-section of the apertures may be constant (tubular) through the thickness of the hydrogel sheet.
  • the apertures may taper through the thickness of the sheet. This can result in apertures substantially in the form of truncated cones. Such apertures allow water to flow more readily in one direction through the sheet than in the opposite direction.
  • such apertures have a base opening dimension (the maximum opening dimension in the top of the apertured sheet) of from 0.1 mm to 3 mm, and an apical opening dimension (remote from the top of the apertured sheet) of from 0.05 to 2 mm. More preferably, the apertures have a base opening dimension as herein defined of from 0.5 mm to 2 mm, and an apical opening dimension of from 0.1 to 1.0 mm. Preferably, the apertures have an average angle of taper (measured from the perpendicular to the plane of the apertured sheet) of from 10 to 60 degrees.
  • the apertured hydrogel sheet is self-supporting. That is to say, the apertured sheet does not have any reinforcing or supporting sheet, web, net or member embedded therein or laminated thereto.
  • the apertured hydrogel sheet normally consists essentially of the hydrogel composition as hereinafter described.
  • the self-supporting nature of the sheet implies that the hydrogel composition has a minimum inherent strength.
  • the hydrogel composition (measured on a continuous strip (2.5 cm wide) of the hydrogel in accordance with ASTM 412) has a breaking force of 0.5- 10 N, more preferably 1-
  • the thickness of the apertured sheet (by ASTM D374-79) is from about 0.2 to about 4 mm, more preferably from about 0.4 to about 2 mm.
  • the hydrogel layer has a dry basis weight of from about 10 to about 1000g/m 2 , more preferably from about 20 to about 200g/m 2 , and most preferably from about 40 to about 100g/m 2 .
  • water-swellable hydrogel composition refers to compositions that absorb water to form a gel with water under physiological conditions of temperature and pH. Such compositions comprise medically acceptable macromolecular materials that have the ability to swell and absorb wound fluid while maintaining a strong integral structure. Normally, the hydrogel composition is substantially insoluble in water under physiological conditions, whereby the hydrogel is not washed away by the wound fluid.
  • the hydrogel may comprise a biopolymer, i.e it may be formed from a polymer found in nature such as collagen, gelatin or alginate.
  • the hydrogel may be bioabsorbable. That is to say, it may undergo gradual resorption in vivo.
  • the apertured sheet according to the present invention absorbs at least about 10% w/w of water preferably at least about 25% w/w of water, more preferably at least about 50% w/w of water, and still more preferably at least about 100% w/w of water on immersion at 25°C for 60 minutes, based on the weight of the sheet before immersion.
  • Exemplary insoluble gels include certain cross-linked polyacrylate gels such as those described in EP-A-0676457, calcium alginate gels, cross-linked hyaluronate gels, gels of alginate derivatives such as propylene glycol alginate, and gels wherein the hydropolymer is formed from vinyl alcohols, vinyl esters, vinyl ethers and carboxy vinyl monomers, meth(acrylic) acid, acrylamide, N-vinyl pyrrolidone, acylamidopropane sulphonic acid, PLURONIC (Registered Trade Mark) (block polyethylene glycol, block polypropylene glycol) polystyrene-, maleic acid, NN- dimethylacrylamide diacetone acrylamide, acryloyl morpholine, and mixtures thereof.
  • Suitable hydrogels are also described in US-A-5352508.
  • the hydrogel composition comprises a macromolecular material selected from polyurethane gels, biopolymer gels, carboxymethyl cellulose gels, hydroxyethyl cellulose gels, hydroxy propyl methyl cellulose, polyacrylate and mixtures thereof.
  • Suitable biopolymer gels include alginates, pectins, gelatin gels, galactomannans such as guar and xanthan, chitosan, gelatin, hyaluronates and mixtures thereof. Some of these biopolymer materials also promote wound healing.
  • the gels are chemically or physically cross-linked, and the chemical cross-linking may be either covalent or ionic.
  • the apertured sheet may comprise at least 50% w/w based on the weight of the sheet before swelling of the gel-forming macromolecular materials, more preferably at least 75% w/w.
  • the hydrogel material may further comprise from about 5 to about 50% by weight, preferably from 15 to 40% by weight, on the same basis of one or more humectants such as glycerol.
  • the hydrogel material may further contain up to about 30% w/w, more preferably up to about 15% w/w on the same basis of water.
  • the hydrogel composition may further comprise up to about 10% w/w, preferably from 0.1% to 5% w/w of a medicament based on the weight of the composition before swelling.
  • Suitable medicaments include antiseptics such as silver sulfadiazine, chlorhexidine, triclosan or povidone iodine, analgesics, steroids, antibiotics, growth factors or mixtures thereof.
  • antiseptics such as silver sulfadiazine, chlorhexidine, triclosan or povidone iodine, analgesics, steroids, antibiotics, growth factors or mixtures thereof.
  • the apertured sheet according to the invention is substantially sterile.
  • the apertured sheet according to the present invention may in some embodiments be adhesive.
  • the hydrogel composition of the sheet itself is adhesive.
  • a medically acceptable pressure sensitive adhesive may be applied to a surface of the apertured sheet.
  • the hydrogel layer comprises a cross-linked polyacrylate hydrogel material, for example a material of the kind described in EP-A-0676457, WO00/07638, or WO00/45866, the entire contents of which are incorporated herein by reference.
  • the present invention further provides a wound dressing comprising an apertured sheet according to the present invention.
  • the wound dressing comprises an absorbent layer and/or a backing layer in addition to the apertured sheet, in which case the apertured sheet is preferably the wound-facing top sheet of the dressing.
  • the dressing further comprises a backing layer over the back face of the apertured sheet.
  • the backing layer preferably provides a barrier to passage of microorganisms through the dressing and further preferably blocks the escape of wound fluid from the dressing.
  • the backing layer may extend beyond at least one edge of the absorbent layer to provide an adhesive-coated margin adjacent to the said edge for adhering the dressing to a surface, such as to the skin of a patient adjacent to the wound being treated.
  • An adhesive-coated margin may extend around all sides of the absorbent layer, so that the dressing is a so-called island dressing. However, it is not necessary for there to be any adhesive-coated margin.
  • the backing layer is substantially liquid-impermeable.
  • the backing sheet is preferably semipermeable. That is to say, the backing sheet is preferably permeable to water vapour, but not permeable to liquid water or wound exudate.
  • the backing sheet is also microorganism-impermeable.
  • Suitable continuous conformable backing sheets will preferably have a moisture vapor transmission rate (MVTR) of the backing sheet alone of 300 to 5000 g/m 2 /24hrs, preferably 500 to 2000 g/m 2 /24hrs at 37.5 C at 100% to 10% relative humidity difference.
  • the backing sheet thickness is preferably in the range of 10 to 1000 micrometers, more preferably 100 to 500 micrometers.
  • the MVTR of the dressing according to the present invention as a whole is lower than that of the backing sheet alone, because the apertured sheet partially obstructs moisture transfer through the dressing.
  • the MVTR of the dressing (measured across the island portion of the dressing) is from 20% to 80% of the MVTR of the backing sheet alone, more preferably from 20% to 60% thereof, and most preferably about 40% thereof. It has been found that such moisture vapor transmission rates allow the wound under the dressing to heal under moist conditions without causing the skin surrounding the wound to macerate.
  • Suitable polymers for forming the backing sheet include polyurethanes and poly alkoxyalkyl acrylates and methacrylates such as those disclosed in GB-A- 1280631.
  • the backing sheet comprises a continuous layer of a high density blocked polyurethane foam that is predominantly closed-cell.
  • a suitable backing sheet material is the polyurethane film available under the Registered Trade Mark ESTANE 5714F.
  • the adhesive (where present) layer should be moisture vapor transmitting and/or patterned to allow passage of water vapor therethrough.
  • the adhesive layer is preferably a continuous moisture vapor transmitting, pressure-sensitive adhesive layer of the type conventionally used for island-type wound dressings, for example, a pressure sensitive adhesive based on acrylate ester copolymers, polyvinyl ethyl ether and polyurethane as described for example in GB-A-1280631.
  • the basis weight of the adhesive layer is preferably 20 to 250 g/m 2 , and more preferably 50 to 150 g/m 2 . Polyurethane-based pressure sensitive adhesives are preferred.
  • the adhesive layer extends outwardly from the absorbent layer and the envelope to form an adhesive-coated margin on the backing sheet around the adhesive layer as in a conventional island dressing.
  • the area of the optional absorbent layer is typically in the range of from 1cm 2 to 200cm 2 , more preferably from 4cm 2 to 100cm 2 .
  • the optional absorbent layer may be any of the layers conventionally used for absorbing wound fluids, serum or blood in the wound healing art, including gauzes, nonwoven fabrics, superabsorbents, hydrogels and mixtures thereof.
  • the absorbent layer comprises a layer of absorbent foam, such as an open celled hydrophilic polyurethane foam prepared in accordance with EP-A-
  • the absorbent layer may be a nonwoven fibrous web, for example a carded web of viscose staple fibers.
  • the basis weight of the absorbent layer may be in the range of 50-500g/m 2 , such as 100-400g/m 2 .
  • the uncompressed thickness of the absorbent layer may be in the range of from
  • the free (uncompressed) liquid absorbency measured for physiological saline may be in the range of 5 to 30 g/g at 25°
  • the wound dressing according to the present invention is sterile and packaged in a microorganism-impermeable container.
  • the present invention provides a method of manufacture of an apertured sheet, comprising the steps of: providing an apertured substrate sheet; coating an aqueous hydrogel precursor onto the apertured substrate; curing the aqueous hydrogel precursor on the substrate to form an apertured hydrogel layer on the substrate sheet; and separating the cross-linked hydrogel layer from the substrate sheet.
  • the substrate sheet is preferably a perforated thermoplastic film, such as a PTFE film or a polyolefin film or an ethylene vinyl acetate (EVA) film.
  • a perforated thermoplastic film such as a PTFE film or a polyolefin film or an ethylene vinyl acetate (EVA) film.
  • EVA ethylene vinyl acetate
  • vacuum perforated films such as the films with tapered apertures described in GB-A-1526778.
  • the substrate sheet may be a perforated metal or plastic plate, or mesh of metal or thermoplastic filaments.
  • the substrate sheet may be coated with a release coating, such as a silicone release coating, to assist peeling of the apertured sheet product from the substrate.
  • the hydrogel precursor is a pregel composition that forms an insoluble hydrogel upon cooling, polymerisation or cross-linking.
  • examples include aqueous sodium alginate, which can be gelled by calcium salts.
  • guar gum which can be gelled by borate salts.
  • the pregels are curable compositions that comprise one or more monomers and typically one or more crosslinking agents and/or polymerisation initiators.
  • Preferred monomers are acrylate esters, such as 2-hydroxyethyl methacrylate, acrylamides such as N,N-dimethylacrylamide.
  • mixtures of salts or C1-C5 esters of 2- acrylamide-2-methylpropanesulfonic acid and salts or C1-C5 alkyl esters of acrylic acid (3-sulfopropyl) ester are also preferred.
  • Suitable cross linking agents are polyethylene glycol diacrylates.
  • Suitable initiators are conventional peroxide initiators.
  • Suitable pregel materials are the UV-curable polyacrylate pregels described for example in WO00/65143, the entire content of which is incorporated herein by reference.
  • the viscosity of the pregel is adjusted to provide the desired thickness of the pregel layer on the substrate.
  • the pregel can be coated onto the substrate surface for example by spraying or slot coating or extrusion or by means of a doctor blade. Apertures may be formed in the pregel coating, for example, by applying a gas pressure differential across the coated substrate to blow apertures in the coating. Methods of this general type are described, for example, in WO93/19709. Alternatively, an apertured hydrogel coating on an apertured substrate may be made by the method described in WO00/65143, the entire content of which is incorporated herein by reference.
  • the apertured hydrogel sheet is preferably separated from the substrate by peeling.
  • the present invention provides a method of treatment of a wound comprising the step of applying a dressing in accordance with the present invention to the surface of the wound with the apertured hydrogel sheet contacting the wound.
  • An apertured hydrogel sheet according to the invention is prepared as follows.
  • a substrate sheet consisting of a polyethylene film that has been perforated with about 10 perforations per cm 2 , each perforation having a substantially conical shape as hereinbefore described, a maximum hole diameter of about 1.0 mm, an open area of 16% of the total area of the front face, a thickness by weight of about 43 micrometers and an embossed thickness of about 0.5 mm.
  • Such perforated sheets are available from Tredegar Film Products, Richmond, Virginia under the Registered Trade Mark VISPORE.
  • the substrate sheet presents a smooth, perforated top surface. This surface is then coated with a layer of hydropolymer pregel 6 that is applied by spraying.
  • the pregel consists of bovine gelatin in water at about 25°C.
  • the concentration of the gelatin is adjusted in the range 5 to 20% w/w to provide the desired viscosity for a uniform, adherent layer of the desired thickness on the substrate. Suction is then applied to the back face of the substrate to vacuum perforate the pregel layer in register with the perforations in the substrate.
  • the gelatin is then cross-linked by treatment with glutaraldehyde or formaldehyde.
  • the cross-linked gelatin sheet is then dried at 40°C and then peeled from the substrate sheet.
  • the resulting hydrogel sheet has a dry basis weight of 100g/m 2 and consists of bovine gelatin cross-linked with glutaraldehyde or formaldehyde.
  • the sheet has about 10 perforations per cm 2 , each perforation having a maximum hole diameter in the range of about 0.8- 1.2 mm, resulting in an open area of about 5-10% of the total area of the apertured sheet.
  • the gelatin On soaking in water at 25°C for one hour the gelatin swells but does not dissolve, and it can be seen that the holes enlarge, thereby increasing the liquid permeability of the sheet.
  • the sheet can be packaged directly for use, or it can be made up into a multilayer wound dressing according to the invention. It can be sterilized by gamma irradiation.
  • the dressing is removed from the package, and the apertured hydrogel sheet is applied to the wound with the hydrogel in contact with the wound to provide a sterile and absorbent dressing.
  • the hydrogel sheet interacts in hitherto unexpected ways to provide a moist but not wet wound environment for a wide range of wounds over an extended period.
  • An apertured sheet formed from a polyvinyl pyrrolidone (PVP) gel according to the invention is prepared from the following pregel formulation PVP 20%
  • the thus-formed gel solution is then extruded through a slot die onto a substrate sheet of the same kind as in Example 1 moving at a speed of 5 m/minute, at a coating weight of 1000 g/m 2 . Suction is applied to perforate the pregel coating as described in Example 1.
  • the pregel is then cured by passing it through a heating oven at 60 degrees.
  • the resulting cured hydrogel layer is then dried at 40°C and peeled from the substrate.
  • a PTFE mold was prepared with conical projections spaced every 3mm. The projections were 3mm high, and were 2mm diameter at the base and 1mm diameter at the top of the cone.
  • the mold was filled with a polyacrylate monomer solution prepared as follows: 80mls of a solution made from 50% w/v 2- acrylamido-2-methylpropane sulfonic acid; 20mls of water; 5 mis of Potassium Chloride (5%w/v); 0.15ml of a solution prepared from 20 parts PEG400, and 6 parts of 1-hydroxycyclohexylphenylketone.
  • the monomer solution was polymerised by exposure to UV light, and the polymerised gel was peeled from the mould, to provide a self supporting perforated gel.

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  • Biomedical Technology (AREA)
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Abstract

L'invention concerne un matériau feuille à ouvertures, autoporteur, constitué essentiellement d'une composition d'hydrogel pouvant être gonflée à l'eau. Les ouvertures représentent environ 50 % de l'ensemble de la feuille avant le gonflement. L'invention concerne également des pansements réalisés à partir de ce type de matériau feuille, et un procédé relatif à l'élaboration dudit matériau, selon les étapes suivantes: fourniture d'une feuille substrat à ouvertures; revêtement du substrat au moyen d'un précurseur à base d'hydrogel aqueux; durcissement du précurseur sur le substrat pour former une couche d'hydrogel à ouvertures sur ce substrat; et séparation de la couche par rapport au substrat.
PCT/GB2002/003406 2001-07-26 2002-07-25 Materiau feuille a ouvertures, a base de composition d'hydrogel WO2003011352A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP02745682A EP1409030A1 (fr) 2001-07-26 2002-07-25 Materiau feuille a ouvertures, a base de composition d'hydrogel
JP2003516582A JP2004536670A (ja) 2001-07-26 2002-07-25 一定のヒドロゲル組成物から成る孔あけ処理したシート材料

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GB0118250.0 2001-07-26
GB0118250A GB2377939B (en) 2001-07-26 2001-07-26 Apertured sheet materials

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WO2003011352A1 true WO2003011352A1 (fr) 2003-02-13

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DE102008031182A1 (de) 2008-07-03 2010-01-07 Paul Hartmann Ag Wundauflage mit Hydrogelmatrix
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WO2011082772A1 (fr) 2009-12-24 2011-07-14 Paul Hartmann Ag Matrice d'hydrogel à capacité d'absorption élevée pour liquides
WO2011095194A1 (fr) 2009-12-24 2011-08-11 Paul Hartmann Ag Matrice d'hydrogel ayant de meilleures propriétés adhésives
US8961544B2 (en) 2010-08-05 2015-02-24 Lifebond Ltd. Dry composition wound dressings and adhesives comprising gelatin and transglutaminase in a cross-linked matrix
US9017664B2 (en) 2006-12-15 2015-04-28 Lifebond Ltd. Gelatin-transglutaminase hemostatic dressings and sealants
US9044456B2 (en) 2008-06-18 2015-06-02 Lifebond Ltd. Cross-linked compositions
US9066991B2 (en) 2009-12-22 2015-06-30 Lifebond Ltd. Modification of enzymatic crosslinkers for controlling properties of crosslinked matrices
DE102017131013A1 (de) 2017-12-21 2019-06-27 Paul Hartmann Ag Verfahren zur Herstellung einer Wundauflage
DE102017131014A1 (de) 2017-12-21 2019-06-27 Paul Hartmann Ag Verfahren zur Bearbeitung eines Substrats
US10369058B2 (en) 2009-06-16 2019-08-06 3M Innovative Properties Company Conformable medical dressing with self supporting substrate
CN111617306A (zh) * 2020-05-07 2020-09-04 南方医科大学 一种离子导电水凝胶复合敷料及其制备方法
US11122846B2 (en) 2018-10-25 2021-09-21 Cornell University Breathable fabrics with smart pores
CN113905769A (zh) * 2019-04-11 2022-01-07 康沃特克科技公司 超多孔水凝胶、其制造方法和包含其的制品
US20220031910A1 (en) * 2018-10-26 2022-02-03 National Agriculture And Food Research Organization Hydrogel membrane and use thereof
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EP3741335B1 (fr) 2015-09-01 2023-05-24 KCI Licensing, Inc. Pansement présentant une force d'apposition accrue
EP3349807B1 (fr) 2015-09-17 2021-02-24 3M Innovative Properties Company Revêtement adhésif de silicone et d'acrylique hybride destiné à être utilisé dans le traitement de plaies
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US12409072B2 (en) 2019-12-05 2025-09-09 Kci Manufacturing Unlimited Company Multi-layer negative pressure incisional wound therapy dressing
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GB2396109B (en) * 2002-12-12 2006-04-19 Johnson & Johnson Medical Ltd Absorbent multilayer hydrogel wound dressings
WO2004052414A1 (fr) * 2002-12-12 2004-06-24 Johnson & Johnson Medical Limited Pansements hydrogel multicouches absorbants
US9655988B2 (en) 2006-12-15 2017-05-23 Lifebond Ltd Gelatin-transglutaminase hemostatic dressings and sealants
US9636433B2 (en) 2006-12-15 2017-05-02 Lifebond Ltd Gelatin-transglutaminase hemostatic dressings and sealants
US9017664B2 (en) 2006-12-15 2015-04-28 Lifebond Ltd. Gelatin-transglutaminase hemostatic dressings and sealants
WO2009019485A3 (fr) * 2007-08-06 2010-01-07 First Water Limited Pansement de blessure
GB2464080A (en) * 2007-08-06 2010-04-07 First Water Ltd A wound dressing
GB2464080B (en) * 2007-08-06 2011-09-28 First Water Ltd A wound dressing
US8409699B2 (en) 2007-08-20 2013-04-02 Reskin Medical Nv Breathing sheet material having an adhesive coating layer and manufacturing method therefor
EP2027838A1 (fr) * 2007-08-20 2009-02-25 Bio-Racer Matériau de feuille non hermétique doté d'une couche de revêtement adhésif et son procédé de fabrication
WO2009024570A3 (fr) * 2007-08-20 2009-04-09 Bio Racer Matériau en feuille respirant comportant une couche de revêtement adhésif et son procédé de fabrication
US9044456B2 (en) 2008-06-18 2015-06-02 Lifebond Ltd. Cross-linked compositions
US10130521B2 (en) 2008-07-03 2018-11-20 Paul Hartmann Ag Wound dressing
EP3115033A1 (fr) 2008-07-03 2017-01-11 Paul Hartmann AG Pansement et son procédé de fabrication
DE102008031182A1 (de) 2008-07-03 2010-01-07 Paul Hartmann Ag Wundauflage mit Hydrogelmatrix
DE102008031183A1 (de) 2008-07-03 2010-01-07 Paul Hartmann Ag Wundauflage
US10369058B2 (en) 2009-06-16 2019-08-06 3M Innovative Properties Company Conformable medical dressing with self supporting substrate
US10202585B2 (en) 2009-12-22 2019-02-12 Lifebond Ltd Modification of enzymatic crosslinkers for controlling properties of crosslinked matrices
US9066991B2 (en) 2009-12-22 2015-06-30 Lifebond Ltd. Modification of enzymatic crosslinkers for controlling properties of crosslinked matrices
WO2011082772A1 (fr) 2009-12-24 2011-07-14 Paul Hartmann Ag Matrice d'hydrogel à capacité d'absorption élevée pour liquides
US9579413B2 (en) 2009-12-24 2017-02-28 Paul Hartmann Ag Hydrogel matrix having improved adhesive properties
WO2011095194A1 (fr) 2009-12-24 2011-08-11 Paul Hartmann Ag Matrice d'hydrogel ayant de meilleures propriétés adhésives
US8961544B2 (en) 2010-08-05 2015-02-24 Lifebond Ltd. Dry composition wound dressings and adhesives comprising gelatin and transglutaminase in a cross-linked matrix
DE102017131013A1 (de) 2017-12-21 2019-06-27 Paul Hartmann Ag Verfahren zur Herstellung einer Wundauflage
DE102017131014A1 (de) 2017-12-21 2019-06-27 Paul Hartmann Ag Verfahren zur Bearbeitung eines Substrats
US11998654B2 (en) 2018-07-12 2024-06-04 Bard Shannon Limited Securing implants and medical devices
US11122846B2 (en) 2018-10-25 2021-09-21 Cornell University Breathable fabrics with smart pores
US20220031910A1 (en) * 2018-10-26 2022-02-03 National Agriculture And Food Research Organization Hydrogel membrane and use thereof
CN113905769A (zh) * 2019-04-11 2022-01-07 康沃特克科技公司 超多孔水凝胶、其制造方法和包含其的制品
CN111617306A (zh) * 2020-05-07 2020-09-04 南方医科大学 一种离子导电水凝胶复合敷料及其制备方法
CN111617306B (zh) * 2020-05-07 2021-06-15 南方医科大学 一种离子导电水凝胶复合敷料及其制备方法

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GB2377939B (en) 2005-04-20
JP2004536670A (ja) 2004-12-09
EP1409030A1 (fr) 2004-04-21
GB0118250D0 (en) 2001-09-19
GB2377939A (en) 2003-01-29
TW589337B (en) 2004-06-01

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