EP1333788A1 - Pansements avec couche d'hydrogels - Google Patents

Pansements avec couche d'hydrogels

Info

Publication number
EP1333788A1
EP1333788A1 EP01980764A EP01980764A EP1333788A1 EP 1333788 A1 EP1333788 A1 EP 1333788A1 EP 01980764 A EP01980764 A EP 01980764A EP 01980764 A EP01980764 A EP 01980764A EP 1333788 A1 EP1333788 A1 EP 1333788A1
Authority
EP
European Patent Office
Prior art keywords
wound dressing
dressing according
wound
top sheet
layer
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.)
Withdrawn
Application number
EP01980764A
Other languages
German (de)
English (en)
Inventor
Deborah Addison
Derek Walter Silcock
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.)
Johnson and Johnson Medical Ltd
Original Assignee
Johnson and Johnson Medical Ltd
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 Johnson and Johnson Medical Ltd filed Critical Johnson and Johnson Medical Ltd
Publication of EP1333788A1 publication Critical patent/EP1333788A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0203—Adhesive plasters or dressings having a fluid handling member
    • 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
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/51—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the outer layers
    • A61F13/511—Topsheet, i.e. the permeable cover or layer facing the skin
    • A61F13/51121—Topsheet, i.e. the permeable cover or layer facing the skin characterised by the material
    • 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
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/51—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the outer layers
    • A61F13/511—Topsheet, i.e. the permeable cover or layer facing the skin
    • A61F13/512—Topsheet, i.e. the permeable cover or layer facing the skin characterised by its apertures, e.g. perforations
    • 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
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/51—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the outer layers
    • A61F13/511—Topsheet, i.e. the permeable cover or layer facing the skin
    • A61F13/513—Topsheet, i.e. the permeable cover or layer facing the skin characterised by its function or properties, e.g. stretchability, breathability, rewet, visual effect; having areas of different permeability
    • A61F13/51305—Topsheet, i.e. the permeable cover or layer facing the skin characterised by its function or properties, e.g. stretchability, breathability, rewet, visual effect; having areas of different permeability having areas of different permeability
    • 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
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/551—Packaging before or after use

Definitions

  • the present invention relates to wound dressings incorporating an absorbent structure and a hydrogel layer for the maintenance of a suitable moisture level at the surface of wounds.
  • the present invention provides a wound dressing comprising: a liquid- permeable top sheet having a wound facing surface and a back surface, said top sheet being adapted to block or restrict passage of liquid from the back surface to the wound facing surface; and a hydrogel layer on the wound facing surface of the top sheet.
  • the dressing further comprises a backing layer over the back face of the top sheet.
  • the backing layer supports the top sheet and an intermediate absorbent layer (where present) and preferably provides a barrier to passage of microorganisms through 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 top 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 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- 0541391 , the entire content of which is expressly incorporated herein by reference.
  • 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 0.5mm to 10mm, such as 1 mm to 4mm.
  • the free (uncompressed) liquid absorbency measured for physiological saline may be in the range of 5 to 30 g/g at 25°C.
  • the optional absorbent layer may additionally comprise one or more active therapeutic or antimicrobial agents.
  • Suitable therapeutic agents include growth factors, analgesics, local anaesthetics and steroids.
  • Suitable antimicrobial agents include antiseptics such as silver compounds (e.g. silver sulfadiazine) and chlorhexidine, and antibiotics.
  • the therapeutic or antimicrobial agents are usually added in an amount of from 0.01% to 5% by weight, based on the dry weight of the absorbent layer. Provision of the antimicrobial in the absorbent layer may be preferable for two reasons (1) Simple manufacturing route, and (2) Having the antimicrobial away from the wound would prevent unnecessary exposure to the antimicrobial when it may not be needed, e.g. drier wounds.
  • the top sheet of the wound dressing according to the invention is liquid permeable, but acts to block or restrict the flow of liquid from the back surface to the wound site. That is to say, the top sheet allows fluid to pass through the top sheet from the wound site, but blocks or restricts flow of the fluid back through the top sheet onto the wound (also known as wet-back).
  • Such non-wetting or top sheets may for example be made from porous non-woven fabrics comprising a layer of hydrophobic fibers, or having a hydrophobic finish applied to at least the outer surface thereof.
  • the top sheet has greater liquid permeability to the flow of liquid away from the wound facing surface than to the flow of liquid towards the wound facing surface.
  • the top sheet is formed from a substantially liquid-impermeable sheet material provided with tapered capillaries, each capillary having a base substantially in the plane of the wound facing surface of the top sheet and an apical opening remote from the wound facing surface of the top sheet and preferably in contact with an absorbent layer.
  • the conical capillaries provide rapid one-way wicking of fluid from the front of the top sheet, with minimal wetback. Top sheets of this type are described in GB-A-1526778.
  • the top sheet film may be formed from a thermoplastic film-forming polymer.
  • the polymer is conformable but not substantially elastomeric. Suitable polymers include, but are not limited to, polyethylene, polypropylene, polyester, polyamides such as nylons, fluoropolymers such as polyvinylidene fluoride (PVDF) or polytetrafluoroethylene (PTFE), and mixtures thereof.
  • the top sheet is preferably a polyolefin film.
  • the film has a thickness by weight (ASTM E252-84) of from 10 to 200 micrometers, more preferably from 25 to 100 micrometers.
  • the capillaries are substantially in the form of truncated cones.
  • the capillaries have a base opening dimension (the maximum opening dimension in the plane of the top sheet) of from 0.1 mm to 3 mm, and an apical opening dimension (remote from the plane of the top sheet) of from 0.05 to 2 mm. More preferably, the capillaries have a base opening dimension as herein defined of from 0.3 mm to 1 mm, and an apical opening dimension of from 0.1 to 0.5 mm.
  • a hydrogel layer to the top surface of such a top sheet enables a moist wound environment to be maintained for prolonged periods, over a wide range of wound exudation rates.
  • the top sheet continues to wick away wound fluid to prevent excessive moisture in the wound, but this does not result in removal of the hydrogel or blocking of the top sheet by the hydrogel.
  • the hydrogel absorbs moisture vapor from the absorbent layer and preserves a moist wound contacting surface.
  • the hydrogel does not give rise to substantially increased wet-back through the top sheet.
  • the hydrogel layer has a dry basis weight of from 10 to 200g/m 2 , more preferably from 10 to 100g/m 2 , and most preferably from 10 to 50g/m 2 .
  • hydrogel layer refers generally to layers that interact with the wound surface under physiological conditions to maintain an elevated moisture level at the wound surface.
  • the hydrogel layer forms a gel with water under physiological conditions of temperature and pH.
  • Such hydrogel layers can be formed by the inclusion of medically acceptable macromolecular materials that preferably have the ability to swell and absorb fluid while maintaining a strong integral structure.
  • the hydrogel material is substantially insoluble in water under physiological conditions, whereby the hydrogel is not washed away by the wound fluid.
  • the hydrogel may be a biopolymer, and/or it may be bioabsorbable. That is to say, it may undergo gradual resorption in vivo.
  • Exemplary insoluble gels include certain cross-linked polyacrylate gels, calcium alginate gels, cross-linked hyaluronate gels, wherein the hydrogel layer comprises a hydrogel material selected from gels 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.
  • PLURONIC Registered Trade Mark
  • the gel adheres strongly to the surface of the top sheet material to resist washing off by wound fluid.
  • the gel may be chemically bonded to the surface of the top sheet.
  • the hydrogel layer comprises a hydrogel material selected from polyurethane gels, biopolymer gels, carboxymethyl cellulose gels, hydroxyethyl cellulose gels, hydroxy propyl methyl cellulose, modified acrylamide and mixtures thereof.
  • Suitable biopolymer gels include alginates, pectins, galactomannans, chitosan, gelatin, hyaluronates and mixtures thereof. Some of these biopolymer materials also promote wound healing.
  • the gels are cross-linked, and the cross-linking may be either covalent or ionic.
  • the hydrogel material further comprises from 5 to 50% by weight on a dry weight basis of one or more humectants such as glycerol.
  • the hydrogel layer may additionally comprise one or more active therapeutic or antimicrobial agents.
  • Suitable therapeutic agents include growth factors, analgesics, local anaesthetics and steroids.
  • Suitable antimicrobial agents include antiseptics such as silver compounds (e.g. silver sulfadiazine) and chlorhexidine, and antibiotics.
  • the therapeutic or antimicrobial agents are usually added in an amount of from 0.01 % to 5% by weight, based on the dry weight of the hydrogel layer.
  • the hydrogel layer may be continuous or discontinuous, but in any case is preferably apertured in register with the capillaries in the top sheet so as not to obstruct passage of fluid into the capillaries even when the hydrogel is fully swelled. In other words, there is preferably substantially no hydrogel initially present in or covering the capillaries of the top sheet.
  • the hydrogel layer may be applied by spraying or, preferably, by a printing or transfer process.
  • the multilayer wound dressing according to the invention further comprises one or more protective cover sheets over the hydrogel layer and any exposed adhesive.
  • these may comprise one or more release-coated paper cover sheets.
  • the dressing is sterile and packaged in a microorganism-impermeable container.
  • Figure 1 shows a perspective view of the lower (wound contacting) surface of a wound dressing according to the invention.
  • Figure 2 shows a partial transverse cross section (not to scale) through the island region of the dressing of Figure 1.
  • the wound dressing is an island-type self-adhesive wound dressing comprising a backing layer 1 of microporous liquid-impermeable polyurethane foam, such as ESTANE 5714F (Registered Trade Mark).
  • the backing layer is permeable to water vapor, but impermeable to wound exudate and microorganisms.
  • the top sheet 4 extends over the absorbent layer 3 and is wrapped partially around the absorbent layer 3 and the edges 5 of the top sheet are adhered to the backing layer 1 behind the absorbent layer 3 by the adhesive 2. This can be seen more clearly in Figure 2.
  • the top sheet is a polyethylene film that has been perforated with about 90 perforations per cm 2 , each perforation having a substantially conical shape as hereinbefore described, a maximum hole diameter of about 0.5 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 top sheets are available from Tredegar Film Products, Richmond, Virginia under the Registered Trade Mark VISPORE.
  • the top sheet 4 presents a smooth, perforated top surface to the wound This surface is coated with a layer of hydrogel 6 applied by spraying that is apertured in register with the capillaries in the top sheet to allow passage of fluid into the capillaries even when the hydrogel is fully swelled.
  • the hydrogel 6 has a dry basis weight of 30g/m 2 and consists of bovine gelatin cross- linked with glutaraldehyde or formaldehyde.
  • the wound facing surface of the dressing shown in Figure 1 is protected by two silicone-coated release papers 8,9, packed in a microorganism-impermeable pouch, and sterilised using gamma radiation.
  • the dressing In use, the dressing is removed from the package, the release papers are removed, and the dressing is adhered to the skin around the wound with the top sheet and hydrogel in contact with the wound to provide a sterile and absorbent dressing.
  • the hydrogel and top sheet interact in hitherto unexpected ways to provide a moist but not wet wound environment for a wide range of wounds over an extended period.

Abstract

L'invention porte sur un pansement contenant : une couche supérieure perméable aux liquides présentant une surface venant en contact avec la plaie et une surface arrière, ladite couche supérieure étant conçue de manière à bloquer ou restreindre le passage d'un liquide de la surface arrière vers la surface de contact avec la plaie ; et une couche d'hydrogel insoluble, placée sur la surface venant en contact avec la plaie de la couche supérieure.
EP01980764A 2000-11-13 2001-11-12 Pansements avec couche d'hydrogels Withdrawn EP1333788A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB0027674.1A GB0027674D0 (en) 2000-11-13 2000-11-13 Hydrogel wound dressings
GB0027674 2000-11-13
PCT/GB2001/004983 WO2002038097A1 (fr) 2000-11-13 2001-11-12 Pansements avec couche d'hydrogels

Publications (1)

Publication Number Publication Date
EP1333788A1 true EP1333788A1 (fr) 2003-08-13

Family

ID=9903069

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01980764A Withdrawn EP1333788A1 (fr) 2000-11-13 2001-11-12 Pansements avec couche d'hydrogels

Country Status (6)

Country Link
EP (1) EP1333788A1 (fr)
JP (1) JP2004520096A (fr)
AU (1) AU2002212552A1 (fr)
GB (1) GB0027674D0 (fr)
TW (1) TW590763B (fr)
WO (1) WO2002038097A1 (fr)

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GB2382775B (en) 2001-12-06 2005-05-25 Johnson & Johnson Medical Ltd Controlled release therapeutic wound dressings
GB2393655B (en) 2002-09-27 2005-08-24 Johnson & Johnson Medical Ltd Wound treatment device
GB2396109B (en) * 2002-12-12 2006-04-19 Johnson & Johnson Medical Ltd Absorbent multilayer hydrogel wound dressings
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EP2338528B1 (fr) 2009-12-24 2013-05-29 Paul Hartmann AG Matrice d'hydrogel dotée d'une capacité d'absorption élevée pour des liquides
EP2338529B1 (fr) 2009-12-24 2013-05-29 Paul Hartmann AG Matrice d'hydrogel dotée de propriétés d'adhésion améliorées
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DE102017131014A1 (de) 2017-12-21 2019-06-27 Paul Hartmann Ag Verfahren zur Bearbeitung eines Substrats
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Also Published As

Publication number Publication date
WO2002038097A1 (fr) 2002-05-16
TW590763B (en) 2004-06-11
AU2002212552A1 (en) 2002-05-21
GB0027674D0 (en) 2000-12-27
JP2004520096A (ja) 2004-07-08

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