AU646400B2

AU646400B2 - Adhesive dressings

Info

Publication number: AU646400B2
Application number: AU60603/90A
Authority: AU
Inventors: Patrick Lewis Blott; David Alan Rawlings
Original assignee: Smith & Nephew; Smith and Nephew PLC
Current assignee: Smith and Nephew PLC
Priority date: 1989-08-03
Filing date: 1990-08-01
Publication date: 1994-02-24
Anticipated expiration: 2010-08-01
Also published as: JPH05501073A; WO1991001707A1; JP3025010B2; EP0484415A1; AU6060390A; ZA906086B; GB8917790D0; CA2058421A1; CA2058421C

Description

WO 91/01707 P(7-r/ B90/01194 r -I ADHESIVE DRESSINGS This invention relates to adhesive dressings and particularly to adhesive bandages as would be suitable for first-aid dressingz.

A prime requirement for first-aid dressings is that they should be highly conformable and pliable since they have to be used for the dressing of highly rounded surfaces such as fingers as well as for flexing surfaces such as knuckles.

Conventionally first-aid dressings are formed as a relatively bulky but small pad of an absorbent material such as gauze layers adhered to a larger backing sheet made of a woven fabric or filmic material. Usually the pad is covered by layers of coverstock intermediate the pad material on the wound to reduce adherence between the wound eschar and the fibres of the absorbent material.

The manufacturing of such dressings requires need to maintain accurate registry between the coverstock and the pad and the pad and backing layer during the production stage.

Known dressings may also suffer from the 2disadvantage, that because they are manufactured from highly porous materials, air-borne bacteria can enter the dressing and infect the wound. This problem may be further accentuated where the dressings are not water proof and water-borne bacteria and viruses can enter or leave the dressings.

We have now found that the problems associated with manufacture and bacterial contamination may be reduced by highly pliable and conformable dressing comprises a composite of coextensive layers.

According to the present invention there is provided a conformable wound dressing comprising an absorbent layer comprising polymeric foam, an adhesive layer over the edges of the body facing surface of said absorbent layer and a layer of a liquid impervious moisture vapour permeable material over the opposed surface of and substantially coestensive with said absorbent layer wherein a single region comprising at least 40% of the area of said body facing surface of said absorbent layer is free of the adhesive layer.

The dressings of the invention may be in the form of a composite comprising three layers, a top moisture vapour permeable layer, an intermediate absorbent layer and a bottom or wound facing adhesive layer.

3 In an alternative embodiment a fourth or intermediate layer, coextensive with the absorbent layer may be positioned intermediate the absorbent and adhesive layers. The fourth layer should be a discontinuous layer so as not to impair the performance of the absorbent layer.

The adhesive layer may be confined to edges of the absorbent layer or the intermediate discontinuous layer. Preferably the adhesive free layer is greater than 50%, more preferably at least 85% free.

Typically, a single adhesive free area would be located centrally on the body facing surface of the dressing and would constitute the wound contacting surface. The adhesive surrounding this wound contacting surface of the absorbent or intermediate would secure the dressing to the intact skin around the wound.

Normally, the layers of the dressing are attached in a contiguous manner so as to form a laminate.

IJ/bk/13192/2709 PCT/GB 90 0 1 1 12 n7 91 4 1 2 July 1991 Wound dressings of the invention can suitably have an moisture vapour transmission rate (MVTR) of at least 300 and preferably at least 500 grams/m 2 /24 hrs at 37.5 0 C at 100% to 10% relative humidity difference.

Typically the MVTR will be between 300 to 5000 and preferably 500 to 2000 grams/square metre/24 hours at 37.5 0 C at 100% to 10% relative humidity difference when in contact with water vapour but not liquid water. It has been found that such moisture vapour transmission rates will allow the wound under the dressing to heal under moist conditions without causing the skin surrounding the wound to macerate.

The moisture vapour transmission rate as determined in contact with water vapour but not liquid water and is determined as follows: Discs of the material under test are clamped over Payne Permeability Cups (flanged metal cups) using sealing rings and screw clamps. The exposed surface area of the test sample is 10cm 2 Each cup contains approximately 10ml of distilled water.

After weighing the cups are placed in a fan assisted electric oven which is maintained at 37±t1C.

The relative humidity within the oven is maintained at approximately 10% by placing 1Kg of anhydrous 3-8 mesh IU d CIco SUBSTITUTE SHEET WO 91/01707 PCT/GB90/01194 5 calcium chloride on the floor of the oven.

The cups are removed after a predetermined period of time allowed to cool for 20 minutes and re-weighed.

The MVTR of the test material is calculated from the weight loss and expressed in units of grams of weight per square metre per 24 hours.

The adhesives employed in the present invention are suitably those which do not adhere to the moist surface of the healing wound. The adhesive on the wound facing surface of dressings of the invention then allows these dressings to be adhered to the skin around the wound site.

The adhesive may be applied as a coating on the absorbent layer or on a intermediate discontinuous layer. In another embodiment the adhesive may be formed in situ on the intermediate or absorbent surfaces, eg by the polymerisation of a non-adhesive monomeric precursor.

The adhesive may be a discontinuous layer or more preferably a continuous layer. A discontinuous layer, may be randomly distributed, for example as spots or as a layer of a porous adhesive. Alternatively, the adhesive may be a regularly patterned discontinuous WO 91/01707 PCr/GB90/01194 6 layer in the form of regularly arranged spots or lines or in a grid arrangement.

Where the adhesive is coated on to the discontinuous layer, the adhesive may be a continuous coating on the surfaces of the intermediate layer. The adhesive layer will itself be discontinuous, the discontinuities registering with the discontinuities in the intermediate layer.

The adhesive layer is not coextensive with the absorbent layer. It is desirable that adhesive be present at the edges of the dressing. The adhesive may be coloured differently from that of the absorbent layer or intermediate layer to provide a visual distinction as a guide for locating the non-adhesive wound contacting surface over the wound. The absorbent layer or intermediate layer will therefor be the direct wound-contacting layer; with a peripheral layer of adhesive for securing the dressing to intact tissue.

It is preferred that at least 10% of the wound facing surface of the absorbent or intermediate layer be covered with adhesive and that the adhesive be present at all the peripheral regions of the wound facing layer.

WO 91/01707 PCT/GB90/01194 7 Suitable adhesive layers for the wound facing layer of dressings of the invention have a thickness of at least 15 microns and may more aptly be from 15 to microns preferably from 25 to 50 microns. Suitable adhesives for the wound facing layer can be any of those pressure sensitive adhesives normally used for adhesive surgical or medical dressings. Preferred pressure sensitive adhesives comprises acrylate ester copolymers and polyvinyl ethyl ether adhesives, such as those disclosed in United Kingdom Patent Specification No. 2070631 and European Patent Specification Nos.

0099675 and 0194881.

The material employed for the discontinuous layer intermediate the adhesive and the foam absorbent layer may be a conformable, elastomeric film provided with apertures or .may be a plurality of conformable, elastomeric polymer strands laid down to a net of desired shape, size and configuration. In another embodiment the discontinuous layer may be formed from a non-woven material.

Aptly the discontinuous layer is formed from a polymeric film. The film may be perforated, apertured or cut to provided. Alternatively the film may be subjected to physical treatments to form a net.

WO 91/01707 PCT/GB90/01194 8 The conformable elastomeric discontinuous film or net allows wound exudate to pass to the absorbent foam layer but prevents the absorbent layer making direct contact with the wound surface.

Preferably, the discontinuous layer used in this invention is an integral net, that is a net with strands and junctions which have been formed integrally from a unitary film during manufacture.

Preferably vhe discontinuous layer is sufficiently conformable to allow the wound dressing to conform with the body contours and thereby maintain overall contact with the wound surface to ensure that exudate from the wound is absorbed.

It is also desirable that the discontinuous layer should be sufficiently elastically extensible to adjust to any dimensional changes in the absorbent layer which may occur, for example, by expansion on liquid uptake.

Suitable discontinuous layers will have elongation at break of 100% to 800% desirably 200% to 750% and preferably 300% to 700% when measured as a wide strip at a 30cm/minute strain rate at 20 0

C.

Normally the discontinuous layer of elastomer is WO 91/01707 PCT/GB90/01194 9 made of a pharmaceutically acceptable water insoluble elastomer.

Suitable elastomers for use in manufacturing the discontinuous layer include polyurethanes, polybutadiene and the like. Such elastomers may be present as block copolymers with other polymer constituents.

The preferred material for the nets are thermoplastic polyurethanes.

Polymer blends having a continuous phase of an elastomer and a discontinuous or discrete phaseof a polymer which is an incompatible with the elastomer may also be used for the discontinuous intermediate layer eg. net. Suitable polymer blends include blends of elastomers such as polyurethanes or ethylene-vinyl acetate copolymers as the continuous phase and incompatible polymers such as an olefine, for example polystyrene.

Preferred thermoplastic polyurethanes are linear polyurethanes containing polyether or polyester groups.

Suitable linear polyester polyurethanes are disclosed in United States Patent Specification No. 2871218.

Suitable linear polyether polyurethanes are disclosed WO 91/01707 PCT/GB90/01194 10 in United States Patent Specification No. 2899411.

Favoured thermoplastic polyurethanes include Estanes from B.F. Goodrich Corp. Preferred solution casting grades are Estane 5714F1, 5702 and 5703. A preferred extrusion grade is Estane 580201.

Suitable polybutadienes are 1,2 polybutadienes.

Favoured 1,2 polybutadienes contain a major amount of syndiotactic 1,2 polybutadiene, have a crystallinity of to 30% and an average molecular weight in excess of 100,000. Preferred 1,2 polybutadienes are known as RB 810, RB820 and RB 830 made by Japan Synthetic Rubber Company.

The net of the discontinuous layer of the dressing can have any convenient form depending on the chosen arrangement of strand, junctions and aperture areas and also their shapes and relative size.

The number and size of the apertures in the net will be sufficient to allow the wound exudate to pass through the film to the absorbent layer. Most aptly the net is adapted so that the size of apertures in combination with the thickness of the film prevent the absorbent layer contacting the wound surface. The nets can have apertures with a dimension of at least 0.05mm.

Generally the aperture size can be upto 4mm. Suitable WO 91/01707 PCT/GB90/01194 11 nets have apertures with a dimension of from 0.05 to 4mm, more aptly from 0.05 to 2.5mm or 0.05 to 2.0, and preferably from 0.1 to 2.5mm. Thenet thickness may be greater than 0.01mm. Net thicknesses of upto 2.5mm may be aptly used. Thus a suitable net can have a thickness of 0.01 to 2.5mm, typically of 0.01 to 0.25mm and preferably of 0.05 to 0.5mm. Favoured nets of the invention have 4 to 40 apertures per cm v~ ch dimension of 0.05 to 2.5mm. The wound face of the net will have to 80% of its area void (the apertures), more suitably will have 25 to 75% of its area void and most suitably will have 35 to 65% of its area void.

The net of the wound dressing of the invention can have any convenient form depending on the chosen arrangement of strand, juncture and hole areas and also their shapes and relative size.

In one preferred form the net consists essentially of longitudinal and transverse strands intersecting at right angles to give a square grid hole pattern.

Suitable nets of this type aptly have 2 to strands per cm, desirably 4 to 40 strands per cm and preferably 2 to 24 strands per cm in both longitudinal and transverse directions.

WO 91/01707 PCT/GB90/01194 12 Variations on the square grid pattern can give other desirable forms of the integral net. Unequal density of strands in either the longitudinal or transverse directions will give rectangula'' hole areas.

Continuous parallel strands in one direction with a staggered arrangement of connecting strands in the other direction will give a "brick-work" pattern.

Other apt forms of the inegral polymer nets can have strands at an angle to the longitudinal or transverse direction (that is diagonal strands). Another preferred form of the integral polymer net can have a staggered arrangment of circular or approximately circular (for example hexagonal) arrangements of strands and hole areas. The integral polymer net can be in the form of a mixed pattern of two or more of the arrangements id desired.

The apertured film or net used in this invention aptly will have a weight of at least 10gsm and may have a weight of from 10gsm to 80gsm, preferably from to The adhesive layer or combination of adhesive and discontinuous layer is preferably distensible such that distortion of the dressing does not occur during dimensional changes in the absorbent layer which may WO 91/01707 PCT/GB90/01 94 13 occur, for example by expansion in liquid uptake or on body surtace movement eg. flexing or stretching over a knuckle or elbow.

The absorbent employed in the absorbent layer of the dressings of the present invention is a polymer foam. The foam is preferably a highly conformable hydrophilic foam, more preferably an open celled foam.

The conformable hydrophilic polymer open cell absorbent layer used in dressings of the invention is capable of absorbing wound exudate. It is desirable that the hydrophilic polymer form layer absorbs the wound exudate rapidly as this enhances the low adherency properties of the absorbent pad. Such rapid absorption prevents undesirable pooling of exudate beLween the .dressing and the wound.

The ability of open cell hydrophilic polymer foam layers to absorb and retain fluids depends to some extent on the size of the foam cells, the porosity of the foam and the thickness of the foam layer.

Suitable open cell hydrophilic foams of dressings of the invention have a cell size of in excess of microns. Generally the foams will have cell sizes of less than 700 microns. Thus foams having a cell WO 91/01707 PCT/GB90/01194 14 weight of 30 microns to 700 microns may be aptly used.

Preferably the cell size of the foam will be from microns to 500 microns. Apt open cell hydrophilic foams of dressings of the invention have at least and aptly from 20% to 70%, preferably 30% to 60% of the total membrane area of the cells as membrane openings.

Such open cell foams permit transport of fluid and cellular debris into and within the foam.

Apt foams may be polyurethane, carboxylated butadiene styrene rubber, polyacrylate or the like foam. Such foams may be made of hydrophilic materials per se or may be treated to render them hydrophilic, for example with surfactants. It is much preferred to use foams which are made of polymer which is itself hydrophilic as it has been found the the exudate is less likely to coagulate rapidly.

The use of such foams of hydrophilic polymer in the absorbent pad of dressings of the invention can allow the wound to be maintained in a moist condition even when the exudate produced has been absorbed and removed from the wound surface.

Favoured hydrophilic polymer foams are hydrophilic polyurethane and especially those which are made of crosslinked hydrophilic polyurethane.

WO 91/01707 PCT/GB90/01194 15 Preferred foams can be made by reacting a hydrophilic isocyanate terminated polyether prepolymer with water.

Suitable hydrophilic polyurethane foams of this type include those known as Hypol foams. Hypol foams can be made from Hypol hydrophilic prepolymers marketed by W.R. Grace and Co.

The conforrable hydrophilic polyurethane foam can be made by mixing together an isocyanate terminated polyether having functionality of more than two with a surfactant and water and casting the mixture onto a surface. This surface advantageously may be the intermediate discontinuous layer.

Preferred isocyanate terminated polyethers include Hypol FHP 2000, 2001, 3000, 3001, 2002 and 2000HD marketed by W.R. Grace and Co. Hypols are described in a booklet published by W.R. Grace and Co.

"Hypol: foamable hydrophilic polymers laboratory procedures and foam formulations". Their preparation and use are disclosed in British Patent Specifications Nos. 1429711 and 1507232.

Suitable surfactants for forming conformable hydrophilic polymer foams include non-ionic surfactants. Favoured non-ionic surfactants are WO 91/01707 PCT/GB90/01194 16 oxypropylene-oxyethylene block copolymers known as Pluronic marketed by BASF Wyandotte. Preferred Pluronics include L65, F87, P38, P75 and L62. Another favoured non-ionic surfactant is a polyoxyethylene stearyl ether known as Brij 72 marketed by Honywell Atlas.

To prepare a suitable foam 100 parts by weight of Hypol FHP 2000, 2001, 3000, 3001, 2002 or 2000HD is mixed with 0.3 to 7 parts by weight of surfactant or mixtures of surfactans and 30 to 300 parts by weight of water and the foaming mixture cast onto a surface.

Typical foaming mixtures have a cream time of about secs., a rise time of about 250 secs. and a cure time of about 400 secs.

A preferred foam for use in the absorbent layer ot the dressings of the invention is disclosed in our United Kingdom Patent Specification No. 2188055 which inter alia there is described a hydrophilic polyurethane foam comprising residues derived from a polyalkylene glycol mono alkyl or mono alkaryl ether.

Such foams can be formed by reacting with water the reaction product of polyisocyanate which has a functionality of greater than 2 and polyalkylene glycol mono alkyl or alkaryl ether.

WO 91/01707 PCT/GB90/01194 17 Preferred polyalkylene glycol mono alkaryl ethers are those in which the alkylene group contains upto 4 carbon atoms. More preferably the alkylene group is ethylene.

Suitable polyalkylene glycol mono alkyl ethers for forming the reaction product are those in which the alkyl group contains 1 to 20 carbon atoms. Alkylene favoured ethers are those in which the alkyl group is a methyl group. Another class of preferred polyalkylene glycol mono alkyl ethers are those in which the alkyl group contains 10 to 18 carbon atoms, eg. lauryl or cetyl.

Suitable polyalkylene glycol mono alkaryl ethers include those in which the aryl moeity is phenyl.

Preferred ethers are those in which the alkyl moeity contains from 1 to 20 carbon atoms eg. octyl or nonyl.

The polyalkylene glycol mono alkyl or alkaryl ether can suitably have an average molecular weight of 180 to 6000. Suitable ethers for forming reaction products used to prepare flexible foams of the invention have an average molecular weight of 180 to 1300 and preferably have an average molecular weight of 350 to 1000.

WO 91/01707 PCT/GB90/01194 18 Suitable ethers for forming reaction products usea to prepare stiff foams of the invention have an average molecular weith of 1500 to 6000 and preferably have an average weight of 3000 to 5000.

Apt ethers are polyethylene glycol mono lauryl ethers having an average molecular weight of approximately 1090 and 360 known as Brij 35 and Brij respectively available from Honeywell Atlas and polyetnylene glycol mono methyl ethers having an average molecular weight of approximately 500 and 5000 known as PEG monomethylether molecular weight 550 and 5000 respectively available from Aldrich Chemicals.

Suitable polyethylene glycol mono nonyl phenyl ethers are commercially available under the Trade names Antarox CO-320 and Antarox CO-990. Apt polyethylene glycol mono nonyl phenyl ethers, having an average molecular weight of approximately 440 and known as Antarox CO-520 and Co-990 respectively available from GAF (Great Britain) Co. Limited.

The polyethylene glycol mono alkyl or alkaryl ether used in the invention will normally contain water. It is preferred however, that the ether contains less than 1% by weight of water to limit the number of urea groups formed in the reaction with the WO 91/01707 PCT/GB90/01194 19 polyisocyanate.

The polyisocyanate used for forming the reaction product will have a functionality greater than 2 for example 2 to 5 and will preferably have a functionality of 2.2 to 3.5. Suitable polyisocyanates include aliphatic and aromatic polyisocyanates. Preferred polyisocyanates are aliphatic polyisocyanate.

Aliphatic polyisocyanates are usually liquid at ambient room temperature and therefore are convenient to use in a liquid reaction mixture. An apt aliphatic polyisocyanate for use in the invention is a biuret of 1,6 hexamethylene diisocyanate which has a functionality of 2.6 known as Desmodur N100 available from Bayer A.G.

Favoured aromatic polyisocyanates for forming the reaction product are polymeric methylene diisocyanates.

Polymeric methylene diisocyanates comprise a mixture of 4,4'-diphenyl methane diisocyanates and one or more of polymeric homologues. Apt polymeric methylene diisocyanates are known as suprasec VM 20, VM 50, DND and VM 90 available from ICI and have a functionality of 2.13, 2.49, 2.70 and 2.90 respectively.

The reaction product suitable for use in the invention can be a reaction product of one or more PCT/G8 90 0 1 1 9 12 07 91 20 1 2 July 1991 polyisocyanates and one or more polyalkylene glycol mono alkyl or aryl alkyl ethers, including mixed alkyl and alkaryl ethers. The reaction product may advantageously be formed using a chain extender.

Suitable chain extenders for use in forming the reaction product include ethane diol, 1.3 propane diol and 1.4 butane diol.

The conformable moisture vapour transmitting outer layer of dressings of the invention when present can be continuous or discontinuous.

A preferred moisture vapour transmitting outer layer is a continuous conformable film. The continuous moisture vapour transmitting conformable film outer layer of the wound dressing of the invention may be used to regulate the moisture loss from the wound area under the dressing and also to act as a barrier to bacteria so that bacteria on the outside surface of the dressing cannot penetrate to the wound area.

Suitable continuous conformable films will have a moisture vapour transmission rate of at least 300, favourably at least 500 and aptly 300 to 5000 grams preferably 500 to 2000 grams/square metre/24 hrs at 37.5 0 C at 100% to 10% relative humidity difference. It has been found that such moisture vapour transmission !i r:J;T!UTE SHEET WO 91/01707 PCT/GB90/01194 21 rate of the continuous film allow the wound under the dressinq to heal under moist conditions without causing the skin surrounding the wound to macerate.

Suitable moisture vapour transmitting continuous films can be made of polyurethane or copolymers of alkoxy alkyl acrylates or methacrylates such as those disclosed in British Patent No. 1280631. Apt polyurethanes and polyurethane films, particularly highly moisture vapour permeable polymers and foams are also disclosed in European Patent Specification No.

0091800.

The continuous moisture vapour transmitting film can be a conformable polyurethane incompatible polymer blend film containing voids. Suitable conformable polyurethane blend films are disclosed in United Kingdom Patent Application GB 2081721A. A preferred film is formed from a blend of polyurethane and high impact polystyrene.

An apt conformable moisture vapour transmitting outer layer comprises a microporous film. The conformable film microporous outer layer of the wound dressing of the invention may be used to regulate the moisture loss from the wound area under the dressing and also to act as a barrier to bacteria to delay or PCT/rl 90 0119 S2 27 91 S22 12 July 1991 prevent bacteria on the outside surface of the dresssing penetrating to the wound area.

Suitable conformable microporous films will have a moisture vapour transmission rate of at least 300 favourably at least 500 and aptly from 300 to 5000 grams, preferably 500 to 4000 grams/square metre/24 hrs at 37.5 0 C at 100% to 10% relative humidity difference.

Suitable conformable microporous films have pore diameter of less than 2 microns desirably less than 0.6 microns and preferably less 0.1 microns. Such microporous films should have pore diameter of greater than 0.01 microns.

Suitable conformable microporous films may have a thickness of greater than 25/. Apt films may have a thickness of less than 400p. Thus suitably the thickness of the film will be from 25 to 400 microns, preferably 50 to 300 microns. Generally, the conformable microporous film will be made of a polymer.

Suitable polymers include polether-polyamide copolymers such as those marketed under the name PEBAX (CATCOCHEM SA) containing a particulate filler, eg chalk, plasticised polyvinyl chloride, polyurethane elastomers and ethylene vinyl acetate copolymer )TITUTE S WO 91/01707 PCT/GB90/01194 23 elastomers.

A favoured conformable microporous film comprises a microporous plasticised polyvinyl chloride film having an average pore diameter of less than 2 microns, a thickness of 250 to 300 microns and a moisture vapour transmission rate of 3000 to 5000 g/m 2 /24 hours at 37.5 0 C at a relative humidity difference of 100% to relative humidity.

The conformable moisture transmitting outer layer of wound dressings of the invention may also comprise a moisture vapour transmitting adhesive layer to bond the outer layer to the layer of open cell foam. The adhesive layers can be continuous or discontinuous.

Suitable adhesive which are moisture vapour transmitting as a continuous layer include various acrylate ester copolymer and polyvinyl ether pressure sensitive adhesives for example as disclosed in British Patent No. 1280631. Favoured pressure sensitive adhesives comprise copolymers of an acrylate ester with acrylic acid for example as disclosed in United Kingdom Application GB 2070631.

The wound dressing of the invention can contain a topically effective medicament. Most suitably the WO 91/01707 PCT/GB90/01194 24 medicament is an antibacterial agent. Preferably the antibacterial agent is a broad spectrum antibacterial agent such as silver salt for example silver sulphadiazine, an acceptable iodine source such as povidone iodine (also called polyvinyl pyrrolidone iodine or chlorhexidine salts such as the gluconate, acetate, hydrochloride or the like salts or quaternary antibacterial agents such as bensalkonium chloride or the like.

The medicament can be located in the foam layer or in the adhesive coating.

The medicament is preferably located in the foam layer of the dressing.

Preferred amounts of suitable medicaments for incorporation into the foam layer of the dressing of the invention are disclosed in the aforementioned patent specifications.

The foam in the absorbent layer may also contain a supersorber. Suitable supersorbers are well known and can include starch and other cellulosic materials such as cross-linked methyl cellulose, as well as known materials containing acrylic unsaturation.

WO 91/01707 PCT/G,90/01194 25 The wound dressing of this invention may be in any convenient form of shape or size. In a preferred form the wound dressing is a pad of rectangular, oval or circular shape. In another preferred form the wound dressing can be an tlongate strip which may be used as a bandage or may be used to prepare smaller dressings.

The dressings may also be of irregular shape for use on flexing or bending surfaces such as knuckles, knees and elbows.

Although the dressings of the invention are suitable as first-aid dressings or bandages, they also have use, as medical or ward dressings.

The dressings of the present invention have a primary use in the field of first-aid and may employed in the home and workplace for the primary dressing of wounds and contusions which may cause minor bleeding such as cuts and abrasions, which do not produce large amounts of wound exudate.

The dressings may be supplied in a variety of shapes and sizes for the dressing of lesions ranging from small cuts, for example on the finger to large skin grazes on, for example, the elbow or knee. The dressings may be square, rectangular, round, oval or oblate in shape. The dressings may be of a specialised WO 91/01707 PCT/GB90/01194 26 shape, for example having a number, of fingers extending from a main or central wound contacting region for the dressing of wound on the knuckle. The central part of the dressing is placed over the wound on the knuckle and the fingers, which have adhesive on the body facing surface and the finger portion adhered to the adjacent fingers and back of the hand.

The dressings of the present invention will generally have a flat profile. However, it may be desirable for the central region, which will be placed over the wound, to be thicker than the margins. The thickness of the marginal regions may be reduced to ensure maximum conformability. The edges of the dressing may be chamfered or feathered. This reduces the possibility that the adhered dressing will 'catch' and be lifted.

Dressings of this configuration allow the hand to flex naturally and freely without the risk of the dressing becoming detached.

The overall dimension of dressings or adhesive bandages in accordance with the invention may be as small as Icm x Icm upto 10cm x 10cm. Alternatively the dressing may be supplied in roll form, with the adhesive preferably disposed along the major edges of WO 91/01707 PCT/GB90/01194 27 the roll and the central area between the adhesive coated margins free of adhesive.

The dressings of the present invention may also be employed as wound dressings for the dressing of wounds and lesions which do not produce large amounts of exudate. Such dressings have application as post-operative dressings for the covering of closed surgical incisions and for wounds treated in hospital casualty units, which require protection but are bleeding profusely or producing large amounts of exudate.

Such wound dressings tend to be of a larger size than those dressings used foi first-aid application in the home and workplace. Wound dressings may be required in sizes ranging from that of the larger first-aid dressing upto for example 50cm x It is desirable that the wound dressing of this invention is sterile. The wound dressing of the invention is advantageously provided in bacteria impervious pouches. Such packed forms can be prepared under aseptic conditions or alternatively sterilised after packing by a conventional procedure. A favoured sterialisation procedure is heat sterilisation, for example by steam. Other favoured procedures ire WO 91/01707 PCT/GB90/01194 28 ethylene oxide sterilisation or gamma irradiation.

In another aspect the present invention provides a process of making a wound dressing of the invention which comprises bringing together a layer of a liquid impervious moisture vapour permeable layer, an absorbent layer comprising polymeric foam and wound facing layer with adhesive on its wound facing surface.

The absorbent layer may be produced by foaming a suitable polymer into a mould to produce the desired shape by casting into a block and cutting the desired shape before combination with the other components or casting with the other components and then cutting.

Normally the bringing together of the layers will be a lamination process. Such lamination processes can also be used to form wound dressings with a conformable moisture vapour transmitting outer layer.

The adhesive can be coated onto the wound facing surface of the discontinuous layer before, during or after the layer has been laminated to the foam layer or directly onto the wound facing surface of the foam. In a preferred process the adhesive in a flowable state is cast into the recesses of a release coated surface having a pattern of discrete raised areas and WO 91/01707 PCT/G B90/01194 29 interconnected recessed areas and the net layer formed in a similar manner on the adhesive layer.

Preferred casting surfaces are embossed polymer sheets. Suitable embossed polymer sheets are disclosed in the aforementioned patent applications.

The adhesive surface of wound dressings of the invention will usually be provided with a release coated protector. The releasq coated protector can be the embossed sheet carrier used for forming the adhesive coated net layer. Other suitable release coated protectors include silicone coated release papers such as Steralease paper nos. 15 and 67 made by Sterling Coated Papers Limited.

The dressings of the invention may be readily manufactured by continuous production techniques. Thus a moisture vapour permeable film and a polymer net may be run in together throught the nip of two rollers or a single roller and a flat bed and a polyurethane foam injected into the nip between the film and net. The foam may be formed in situ at the point of injection by mixing a suitable isocyanate prepolymer as hereinbefore described with, for example, water. After curing of the foam is completed, the embossed composite may then be transfer coated with a suitable adhesive, pre-coated WO 91/01707 PCT/GB90/01194 30 on a releasable carrier sheet. Once the adhesive has been transferred and the carrier sheet removed protector papers for the adhesive may be run onto the adhesive surface, according to conventional techniques.

Finally the dressing may be stamped out by cutting through the composite and the individual dressings packaged.

If desired the dressings may be sterilised during or at the completion of the manufacturing and packaging process.

The present invention will be further described and illustrated by reference to the accompanying drawings in which Figures 1 to 5 and 6a are schemtic representations of sectional elevations of various embodiments of the dressing of the present invention.

Figures 6b and 6c are, respectively, plan views of the top side and underside of the dressing shown in Figure 6a.

A wound dressing 1 comprises a foam absorbent layer 2. An adhesive layer 4 may be coated directly onto the foam layer (Figures 2 and 3) or coated onto an intermediate discontinuous layer 5 such as a net, which in turn is bonded or laminated to the foam absorbent layer 2.

WO 91/01707 PCT/G B90/01 194 31 Overlying the adhesive 4 are a pair of protectors 6, 61 for the adhesive. Overlying the top surface of the absorbent layer 2 is a liquid impervious, water vapour permeable layer 3. In use the release protectors 6, 61 may be peeled away for the adhesive face 4 and the adhesive side of the dressing presented to the skin. The non-adhesive coated region 7 is presented directly to the wound or lesion.

The invention is now illustrated by the following Examples: Example 1 A composite was produced by casting a polyester-polyamide copolymer (Pebax) film, a hydrophilic polyurethane foam, and a polyurethane net.

The polyurethane net was prepared according to the method described in the Examples of European Patent No. 0059048 and then crushed to a thickness of The polyurethane foam was prepared by first producing a prepolymer according to Example 1 of United Kingdom Patent Specification No. 2188055 and then foaming the prepolymer in accordance with the procedure WO 91/01707 PCT/GB90/01194 32 of Example 7 of United Kingdom 2188055.

The casting was carried out according to the manner described in European Patent Specification No.

0059048.

An adhesive was prepared according to Example 1 of United Kingdom Patent Specification No. 2070631 and cast onto a release sheet at a coating weight of m 2 Once the adhesive had dried rectangular areas x 1cm were cut out and the adhesive transfer coated onto the foam surface.

Oblate shapes measuring 6cm x 2.5cm were cut out, with the adhesive free areas centrally disposed to give a first-aid bandage.

The adhesive surface was then covered with release papers and the product finally cut out of the composite sheet, through the embossed region, to produce a first-aid dressing.

Example 2 The procedure of Example 1 was repeated except that the adhesive was transfer coated directly onto the foam absorbent layer. Adhesive 'windows' measuring WO 91/01707 PCT/GB90/01194 33 x 12.5mm were kiss-cut from the coated transfer sheet.

Once the aahesive had been applied, the film-foam-adhesive laminate was embossed and cut to form an oblate first aid dressing measuring 63mm x 22mm. The edges of the dressing were embossed to provide a thin margin 1.5mm wide around the edge of the dressing. A representation of the dressing is shown in Figures 6a, 6b and 6c.

Claims

1. A conformable wound dressing comprising an absorbent layer comprising a polymeric foam, an adhesive layer over the edges of the body facing surface of said absorbent layer and a layer of a liquid impervous moisture vapour permeable material over the opposed surface of and substantially coextensive with said absorbent layer, wherein a single region comprising at least 40% of the area of said body facing surface of said absorbent layer is free of the adhesive layer.

2. A dressing according to claim 1 further comprising a discontinuous layer coextensive with the absorbent layer and intermediate the adhesive layer and the absorbent layer.

3. A dressing as claimed in any one of the preceding claims wherein the adhesive layer is a discontinuous layer.

4. A dressing as claimed in claim 2 or claim 3 wherein the adhesive laye: has discontinuities which 35 register with the discontinuities of the intermediate discontinuous layer.

A dressing as claimed in any one of claims 2 to 4 wherein the intermediate discontinuous layer is in the form of a net.

6. A dressing as claimed in claim 5 wherein the net is a polyurethane net.

7. A dressing as claimed in any ne of the preceding claims wherein the polymeric foam is made from a hydrophilic polymer.

8. A dressing as claimed in any one of the preceding claims wherein the polymeric foam is a polyurethane foam.

9. A dressing as claimed in any one of the preceding claims wherein the moisture vapour permeable layer has a moisture vapour permeability of at least 500g/m2/24hr at 37 0 C at 100% to 10% relative humidity difference.

A dressing as claimed in any one of the preceding claims having a moisture vapour permeability of at least 500g/m2/24hr at 37 0 C at 100% to 10% relative 36 humidity difference.

11. A dressing as claimed in any one of the preceding claims wherein the adhesive is coloured differently from that of the absorbent or intermediate layers.

12. A dressing as claimed in any one of the preceding claims wherein the absorbent layer contains a medicament.

13. A dressing as claimed in any one of claims 2 to 12 wherein the adhesive layer contains a medicament.

14. A conformable wound dressing substantially as hereinbefore described with reference to the accompanying drawings. Dated this 10th day of December, 1992. SMITH NEPHEW PLC By its Patent Attorneys: DAVIES COLLISON CAVE .I v,, /C:

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