WO2011058311A1

WO2011058311A1 - A component for a wound dressing

Info

Publication number: WO2011058311A1
Application number: PCT/GB2010/002071
Authority: WO
Inventors: Helen Shaw; David Pritchard; Bryony Jane Lee; Stephen M. Bishop
Original assignee: Convatec Technologies Inc.
Priority date: 2009-11-10
Filing date: 2010-11-10
Publication date: 2011-05-19
Also published as: EP2498829A1; US10543133B2; EP2498829B1; HRP20140749T1; ES2489165T3; DK2498829T3; PT2498829E; JP5767236B2; AU2010317789B2; JP2013509978A; US20200155379A1; PL2498829T3; CA2780238C; CA2780238A1; AU2010317789A1; GB0919659D0; MX2012005373A; NZ599879A; US20130197460A1

Abstract

An absorbent component for a wound dressing, the component comprising a wound contacting layer comprising gel forming fibres bound to a foam layer.

Description

A COMPONENT FOR A WOUND DRESSING

The present invention relates to a component for a wound dressing and in particular an absorbent component for a wound dressing, the component for use in direct contact with the wound. The present invention also relates to a wound dressing comprising the component as an absorbent component.

It is known to make wound dressings for use on exuding wounds. Such dressings manage the exudate produced by the wound in a variety of ways . For instance, some dressings, mainly those based on foam, manage exudate by absorbing the exudate and allowing the moisture taken up by the dressing to evaporate through the backing or top of the dressing. Such dressings are not designed to absorb and retain the exudate but to absorb and expel the exudate by moisture vapour transmission so that they maximise the level of exudate handled within the limitations of their design. A disadvantage of such dressings is that the lateral spread of the exudate across the dressing is not contained because of the nature of the open structure of the foam and this can cause normal skin surrounding the wound to become macerated as the whole of the dressing surface becomes saturated.

A further disadvantage of the open structure of the foam is that when the dressing is put under pressure, for example when compression is applied or when force is applied to the dressing due to the patient sitting, lying or rolling over, the exudate can be squeezed out of the porous, open foam structure and into contact with the wound and/or surrounding skin surfaces creating the potential for peri-wound maceration and, in the case of chronic wounds, further wound breakdown due to damage caused by certain components of chronic wound exudate. A further disadvantage of such dressings is that rapid loss of exudate by evaporation can cause the wound surface to become desiccated over time which impedes healing.

Other dressings, mainly those based on absorbents that gel, manage exudate by absorbing it and retaining it within the dressing. The moisture in the absorbent can still be lost by vapour transmission from the dressing, but less readily than with a foam absorbent because the exudate is retained and held within the gelled absorbent. As the absorbent is acting as a reservoir for exudate, it needs to have sufficient capacity to retain exudate throughout the wear time of the dressing. This affects the quantity of absorbent needed in the wound dressing which of course affects the thickness and conformability of the dressing overall. In addition, in general with gelling absorbents, particularly fibrous gelling absorbents, the relationship between the thickness of the gelling absorbent layer or its weight per unit area and its absorbency is not linear. This means that a careful balance needs to be struck between absorbency, conformability and moisture vapour transmission.

There is a need for an absorbent component for use in wound dressings which is capable of absorbing exudate at the rate at which it is produced by the wound, which also does not cause maceration to the wound and skin surrounding the wound, which gives a reasonable wear time before needing to be replaced and which is conformable.

We have now developed an absorbent component for a wound dressing which alleviates the above problems and there is provided by a first embodiment of the present invention an absorbent component for a wound dressing, the component comprising a wound contacting layer comprising gel forming fibres bound to a foam layer. We have found that absorbent components according to the invention may mitigate the problems associated with the management of exudate. This is achieved by the combined use of a wound contact layer which absorbs exudate by gelling so that lateral spread of the exudate is contained, with a foam layer which absorbs exudate but readily releases it through moisture vapour transmission.

Surprisingly we have found that the absorbent wound contacting layer appears to control the fluid handling properties of the foam. We believe that the presence of the gel forming wound contact layer limits the lateral spread of exudate in the foam and increases its exudate retention compared to the use of foam alone. In turn the moisture vapour transmission properties of the wound contacting layer may be improved.

The wound contacting layer is present to transport wound fluid away from the wound and absorb it while containing the lateral spread of exudate. The absorbent component preferably has an absorbency of at least lOg/g, preferably from 15g/g to 50g/g and most preferably an absorbency of from 20g/g to 50g/g. The wound contacting layer is fibrous and comprises gel-forming fibres. We have found that fibrous layers as opposed to polymeric layers have the advantage that they are especially able to gel block which resists the lateral spread of exudate. In addition exudate is absorbed rapidly and is retained under pressure.

The fibres suitable for use in the absorbent layer of the present invention include hydrophilic fibres, which upon the uptake of wound exudate become moist and slippery and gelatinous and thus reduce the tendency of the surrounding fibres to stick to the wound. The fibres can be of the type which retain their structural integrity on absorption of exudate or can be of the type which lose their fibrous form and become a structureless gel or a solution upon absorption of exudate.

The fibres are preferably chemically modified cellulose fibres and in particular spun sodium carboxymethylcellulose fibres or cellulose ethyl sulphonate fibres. The carboxymethylcellulose fibres are preferably as described in PCT WO/9312275 or GB93/01258. The fibres may also be pectin fibres, alginate fibres and particularly those as described in W094/17227 or EP433354 or EP476756 or composite fibres of alginate and polysaccharide such as those described in EP 0892863, chitosan fibres, hyaluronic acid fibres, or other polysaccharide fibres or fibres derived from gums . The cellulosic fibres preferably have a degree of substitution of at least 0.05 carboxymethyl groups per cellulose unit. Preferably the gel forming fibres for use in the present invention have an absorbency of either water or saline of at least 15g/g as measured by the free swell absorbency method, more preferably at least 25g/g or 50g/g. The degree of substitution of the carboxymethylated cellulose gel forming fibres is preferably at least 0.2 carboxymethyl groups per cellulose unit, more particularly between 0.3 and 0.5.

The gel forming fibres are preferably mixed to give a wound contacting layer comprising fibres of different absorbencies or properties. The wound contacting layer may comprise other fibres such as textile fibres which can be natural or synthetic, but are preferably cellulosic fibres for example viscose rayon, multi-limbed viscose, cotton or regenerated cellulose having a higher absorbency than most textile fibres. Textile fibres typically have an absorbency of less than lg/g when measured by the free swell absorbency test. The wound contacting layer can be made from a non woven, fibrous web formed by any of the following methods : needle punched, spunlaced, wet- laid, dry laid, meltblown or felted. The web can then be stitch bonded with strengthening fibres or yarns to provide additional strength to the layer such that it retains its structure when saturated with exudate. Additionally the stitchbonded structure may afford higher absorbency or a degree of extensibility to the dressing depending on the nature of the strengthening fibres and yarns used and their stitchbonding pattern. The wound contacting layer is preferably between 20 microns and 5mm thick, more preferably 2mm to 3mm thick and even more preferably from 1mm to 2mm thick.

The foam layer of the present invention is preferably a hydrophilic foam such as polyurethane and more preferably is a hydrophilic open celled foam such as those available from Polymer Health Technologies, Rynel or Filtrona and in particular Filtrona 30W . The foam typically has a thickness of 0.25mm to 5mm, preferably from 1mm to 4.0 mm and most preferably from 1.5mm to 3mm. The foam layer preferably has an absorbency of 10 to 20 g/g when measured by the free swell absorbency method (BS EN 13726-1 :2002)

The foam layer is bonded to the wound contacting layer preferably by a polymer based melt layer, by an adhesive, by flame lamination or by ultrasound. The foam layer may be directly bonded to the wound contact layer to make a laminate structure where the layers co-extend and are separated by the bonding line or the foam layer may form an island in the upper surface of the component surrounded by the wound contacting layer. By forming an island of foam in the upper surface of the absorbent component in this way, the tendency of the foam to laterally spread the exudate in the foam layer and rewet the wound contacting layer is physically limited. A textile layer may be positioned between the wound contact layer and the foam layer to limit distortion of the component that may occur when the foam layer expands on absorption of exudate. The textile layer is preferably made from absorbent fibres such as polyester, nylon, or cotton which may contain superabsorbent components such as cross linked sodium polyacrylate or may be made from a superabsorbent fibre such as polyacrylate. A one-way wicking layer may be positioned between the wound contact layer and the foam layer to assist in the prevention of exudate rewetting the wound contact layer outside the area of the wound by transfer down from the foam towards the wound. The one-way wicking layer has the property that it resists the passage of exudate in one direction. The one- way wicking layer may be Tredegar Premium embossed perforated film made from ethylene-methyl acrylate/ Ethylene vinyl acetate.

A further aspect of the invention relates to a wound dressing comprising the absorbent component. In any wound dressing configuration, the absorbent component contacts the wound so that the gel-forming fibres absorb and retain wound exudate and control the lateral spread of exudate adjacent the wound. Preferably the absorbent component forms an island in direct contact with the wound surrounded by a periphery of adhesive that adheres the dressing to the wound. The adhesive holds the absorbent component in direct contact with the wound and may seal the dressing to the skin surrounding the wound.

The adhesive is preferably a silicone adhesive and more preferably a pressure sensitive silicone adhesive such as Dow Corning MD7-4502 or M67-9900. The adhesive may also be a hydrocolloid, polyurethane, rubber based adhesive or acrylic adhesive. The dressing may also comprise a film layer forming the outer surface of the dressing. Preferably the film layer has an MVTR of at least 1500/m2/24hrs. The film layer is present to provide a bacterial and viral barrier, control moisture vapour transmission and provide a low coefficient of friction to the dressing.

The dressing may also comprise additional optional layers. Preferred embodiments of the invention will now be described by way of example with reference to the accompanying drawings in which:

Figure 1 is a cross sectional view of one embodiment of the wound dressing according to the invention;

Figure 2 is a cross sectional view of a further embodiment of the wound dressing according to the invention showing the foam as an island in the wound contacting layer; and Figure 3 is a cross sectional view of a further embodiment of the wound dressing according to the invention showing a one-way wicking layer separating the layers of the absorbent component.

Referring now to figure 1 of the drawings, the wound dressing comprises an absorbent component 2 comprising a wound contacting layer 4 bonded to a foam layer 6 by an adhesive 8. The component 2 is surrounded by an adhesive 10 so that the wound contacting layer 4 forms an island in the adhesive 10. The dressing has a thin film backing 12 bonded to the component 2 and adhesive 10 by an adhesive 14. Similarly figure 2 shows a wound dressing comprising an absorbent component 2 comprising a wound contacting layer 4 bonded to a foam layer 6 with an adhesive. The component 2 is surrounded by adhesive 10, so that the wound contacting layer forms an island in the adhesive 10. The dressing has a thin film backing 12 bonded to the component 2 and adhesive 10 by an adhesive 14. The foam layer 6 of the component 2 is surrounded by the wound contacting layer 4 so that the foam is an island in the upper surface of the component 2. Figure 2 shows the foam 6 surrounded by a periphery 16 of the wound contact layer 4.

Figure 3 shows a wound dressing comprising an absorbent component 2 comprising a wound contacting layer 2 bonded to a one-way wicking layer 18 which surrounds a foam layer 6. The foam layer 6 forms an island in the one-way wicking layer 18 to assist in the prevention of the foam rewetting the wound contact layer. The surface of the absorbent component 2 furthest from the wound has an island of foam 6 surrounded by a periphery 20 of the one-way wicking layer. The component 2 is surrounded by an adhesive 10 so that the wound contacting layer 4 forms an island in the adhesive 10.

Example 1

The thickness, absorbency, retension and lateral spread of the various layers of the wound dressing component were measured alone and in combination.

Materials used

20gsm Vilmed (44262)

lOOgsm Hydrofiber^® Aquacel^®™ ex ConvaTec

210gsm Hydrofiber^® Aquacel^®™ ex ConvaTec

Polymer Health Technology (PHT) Foam (RM0056/10)

Polymer Health Technology (PHT) Foam (RM0057/10) Wound Dressing Component

Four prototypes were constructed. Prototype construction began by bonding the relevant Hydrofiber^® and foam together using one layer of 20gsm Vilmed and the Prestex PFC 320 set at 200 °C and a motor speed of 1. The completed sheets were then cut to shape using a cutter and Wallace Cutting Press. The various combinations of materials are detailed below. Table 1 : Com onent details

Hydrofibre^® is a gel forming fibre sold in the product Aquacel^® ex ConvaTec. Testing

Absorbency was measured as per BS EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of Absorbency, Section 3.2.2 to 3.2.5.

Following on from the absorbency test, the wet sample was removed from the balance and placed flat on to a perforated stainless steel plate and immediately covered by a weight equivalent to 40mmHg (for a 5cm x 5cm sample, weight 1358g). The weight was left in place for 1 minute before being removed and the sample re weighed.

For determining the % Lateral Spread, the material to be tested was placed on a flat surface and a rigid tube with internal diameter of 29mm was placed on the centre and held in place. 20mls of horse serum was injected into the tube and left for 60 seconds. After 60 seconds had elapsed, any non-absorbed fluid was removed from the material surface with a syringe before removing the vial. A ruler was placed below the dressing and a photograph taken with a digital camera. The area of lateral fluid spread was measured by analyses of photograph in an Image Analyses software package. The percentage lateral spread was calculated as follows:

[(Lateral spread area/vial area) X 100] - 100 Results

Table 2: Fluid absorbed/retained by dressing

Results quoted are the mean of n = 3 It can be seen from the results that doubling the weight of the Hydrofiber or the thickness of foam does not increase the fluid absorbing properties of the materials by a factor of 2. Therefore increasing the thickness of either of these

materials does not provide an optimum solution to increasing the absorbency of the dressing as conformability is compromised. Combining the technologies gives a synergy between absorbency and retention. It can also be seen that the PHT foams' ability to retain fluid is less than that of Hydrofiber. Table 3 Lateral Spread

Results quoted are the mean of n = 3 .

These results show that the wound contact layer controls lateral spread to a greater degree than does foam. Combining the wound contact layer and foam significantly reduces lateral wicking compared to foam alone.

Claims

1) An absorbent component for a wound dressing, the component comprising a wound contacting layer comprising gel forming fibres bound to a foam layer.

2) An absorbent component for a wound dressing as claimed in claim 1 , wherein the absorbent component is in sheet form. 3) An absorbent component for a wound dressing as claimed in claim 1 or claim 2, wherein the wound contacting layer comprises a layer of woven or non- woven or knitted gel forming fibres .

4) An absorbent component for a wound dressing as claimed in any preceding claim, wherein the foam layer is an open cell foam.

5) An absorbent component for a wound dressing as claimed in any preceding claim, wherein the foam layer is a hydrophilic foam. 6) An absorbent component for a wound dressing as claimed in any preceding claim, wherein the foam layer is bound directly to the wound contact layer by an adhesive, polymer based melt layer, by flame lamination or by ultrasound. 7) An absorbent component for a wound dressing as claimed in claims 1 to 4 wherein a textile layer is provided between the wound contact layer and the foam layer.

8) An absorbent component for a wound dressing as claimed in claims 1 to 4 wherein a one-way wicking layer is provided between the wound contact layer and the foam layer. 9) A wound dressing comprising the component of any preceding claim.

10) A wound dressing as claimed in claim 9 wherein the component forms an island in direct contact with the wound surrounded by periphery of adhesive that adheres the dressing to the wound.

11) A wound dressing as claimed in claim 9 or claim 10 wherein the adhesive is a silicone adhesive.

12) A wound dressing as claimed in claims 9 to 11 wherein the dressing is covered by a film layer on the surface of the dressing furthest from the wound.