Sterile nonstick compress

Details Sterile nonstick compress Sterile nonstick compress

1999-09-17

2001-08-07

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

C424S443000, C424S445000, C424S446000, C424S447000, C604S304000

Reexamination Certificate

active

06270792

ABSTRACT:

The present invention relates to a sterile nonstick compress intended to be applied directly in contact with a wound.
PRIOR ART
The advantages of a greasy interface put into direct contact with a wound so as to promote healing, while at the same time ensuring separation between said wound and an absorbent compress, have been known for a long time. One of the products frequently used for covering skin wounds is the “Lumière” tulle gras dressing sold by Solvay Pharma. However, this product, formed from a wide-mesh net made of viscose, coated with a grease based on vaseline and Peru balm, has drawbacks such as, for example, frequent adhesion to the wound or the loss of grease on the handling tools or on the wound after the dressing has been removed. There are also other products, sold or described in the literature, capable of fulfilling the same functions as the aforementioned tulle gras dressing. For example, the dressing with the brand name JELONET sold by Smith and Nephew is known, this being a paraffin-impregnated cotton gauze, the dressing with the brand name ADAPTIC (Johnson and Johnson) which is a viscose knit impregnated with an oil-in-water emulsion: these various products behave in a quite similar manner to the abovementioned “Lumière” tulle gras dressing. Also known is the product with the brand name MEPITEL, sold by Mölnlycke, corresponding to Patent EP 261,167, which is an extensible elastic net covered with a hydrophobic silicone gel capable of adhering to dry skin; however, this product remains little used because of the high cost of silicone gels and its strong adhesion. Among the documents published in a similar field, mention may be made of EP 497,607 which recommends the use of a hydrophilic adhesive resin on a net dressing, but, like the previous product, this has a strong adhesion to perilesional skin and may consequently result in painful removal of the dressing. EP 521,761 describes a healing dressing consisting of a continuous layer of a highly plasticized triblock elastomer having a saturated central block, which layer forms an occlusive, nonstick and highly hydrophobic dressing. In a similar field, mention may also be made of EP 567,704 which describes an antiseptic dressing formed from a hydrogel material impregnated into an absorbent layer which swells in the presence of moisture; in this case, it comprises a continuous layer which essentially seems intended for making a dressing on nonexuding and superinfected wounds. In a similar field of application, EP 420,841 describes a dressing, designed to release an active principle, formed from an adhesive strip to which corpuscles are bonded, these consisting of a hydrophobic matrix in which hydrophobic particles containing the active principle are dispersed. EP 752,840 claims a dressing formed from a thermoplastic polymer forming a hydrogel which is impregnated in a fibrous substrate. The polymer capable of forming a hydrogel is obtained by the copolymerization of hydrophobic groups and hydrophilic groups. The product obtained by the copolymerization is impregnated into the yarns of the substrate, which consists of a cotton gauze for example. The product obtained may be regarded as being a polymer having both a hydrophobic nature and a predominant hydrophilic nature, so that the hydrogel is highly absorbent. According to EP 617,938, a dressing is also known which is composed of an occlusive sheet and a discontinuous polymer layer containing a hydrocolloid, the desired aim being to obtain greater absorption and to prevent leaks.
However, these various products are not entirely satisfactory, either because of a high cost, or because of handling difficulties when putting the dressing in position or removing it, or else because the expected result—i.e. uniform and rapid healing of the wound—can only be achieved with very great difficulty.
As to the last point, which is certainly the most important, it is known that the healing of the wound can progress favorably only if the dressing does not adhere to the newly regenerated tissue and only if the exudates are removed, while still leaving the wound wet.
In use, it seems that the known dressings of the tulle gras type usually adhere strongly to the wound, which generally means that the dressing is painful to remove and considerably reduces the speed of healing because of the disturbance caused by the removal of the dressing. Moreover, it has been noticed that if the compress is too hydrophobic, the wound tends to dry out and that, if the compress is completely hydrophilic, the layer in contact with the wound swells, closes off any passages made in the contact layer and may cause maceration of the wound.
In the medical field, it therefore seems to be desirable to have a wound-contacting compress which is perfectly nonstick to regenerated tissue and which maintains optimum moisture conditions favorable to healing, whilst avoiding the risk of maceration.
SUBJECT OF THE INVENTION
The invention aims to provide a technical solution to the problem mentioned, by means of a sterile nonstick compress of the type comprising an open-mesh flexible fabric, said fabric comprising yarns which are coated with a cohesive and nonstick gel so as to leave the meshes essentially unobstructed, in which compress the gel is formed from a highly plasticized hydrophobic elastomeric matrix containing, in a small amount, a dispersion of hydrophilic particles of a hydrocolloid.
According to one of the preferred embodiments of the invention, the material forming the fabric is a synthetic fiber having long or continuous filaments and, more favorably, is a polyester yarn.
According to another preferred embodiment of the invention, the hydrophobic matrix is based on a high-molecular-weight triblock elastomer of the S-EB-S type.
According to yet another preferred embodiment of the invention, the elastomer is plasticized using a mixture of vaseline and paraffin oil in a proportion of at least 65% by weight of the gel.
According to another preferred embodiment of the invention, the hydrocolloid dispersed in the gel is a sodium salt of carboxymethylcellulose.
DETAILED DESCRIPTION
It has been noticed in fact that the addition of a small amount of hydrocolloid dispersed in a cohesive and elastic, hydrophobic elastomeric matrix gives the surface of the gel obtained a hydrophilic nature, this being combined with the hydrophobic nature of the matrix highly plasticized by an oil, but does not induce water absorbency. These hydrophobic and hydrophilic properties, comparable to an amphiphilic character of the surface of the gel which comes into direct contact with the wound, are translated into a result extremely favorable to the wound-healing process—an optimum degree of moisture maintained on the surface and the presence of grease insulating the structure of the dressing cause more rapid healing and the complete absence of adhesion of the compress to the wound.
The use of a cohesive and elastic gel, stable in a wet environment, allows the yarns of the fabric to be properly trapped, these yarns remaining perfectly isolated from the wound as long as the compress remains in place; there is therefore no risk at any time of establishing direct contact between yarn and regenerated tissue, something which could cause yarn to be introduced into the scar, with, as a consequence, painful destruction of the tissue when removing the dressing. The addition of a large amount of oily plasticizer allows the hydrophobic matrix to be given very pronounced elasticity and flexibility properties; thus, a very compliant compress is obtained which adapts well to the surface to be protected and which at no time deteriorates because of strong cohesion and elasticity of the matrix greater than the elasticity of the coated yarn. Moreover, the oily plasticizer, preferably obtained from a mixture of mineral oil and officinal vaseline, gives a greasy appearance and nonstick properties to the surface of the compress; this results in very limited direct contact between the elastomer and the wound, essentially all contact taking place vi

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