Composition, apparatus, kit and method and uses thereof

Abstract

A curable composition for use in wound care comprising, apportioned between at least one Part A and at least one Part B: one or more alkenyl-group containing polymers (i) having at least one alkenyl group or moiety per molecule, one or more SiH-containing polymers (ii) having at least one Si—H unit per molecule; and a catalyst (iii) for curing by addition of alkenyl-containing polymer (i) to SiH-containing polymer (ii), Part A and Part B independently having viscosity at 23° C. in the range 5-300 Pa·s, preferably 10-100 Pa s, at a shearing rate of 10 s−1, and when combined in one Part having cure time at 23° C. in the range from 0.5 min to 25 min, wherein when dispensed into a location about a wound dressing, said wound dressing overlying a wound site and skin thereabout, said dispensing being so as to intimately contact and overlie an edge of said dressing and skin about said edge, the composition cures in contact with said edge and skin at 32° C. to an elastomer exhibiting zero or low tack at a time in the range from 0.5 to less than 30 minutes, apparatus for use with said composition comprising dispensing apparatus or wound dressing, a kit comprising the same, and methods of dispensing and curing the same and of using the same in sealing a wound dressing and in treating a wound site of a human in need thereof.

Description

[0001]Embodiments relate to a composition, an apparatus, a kit, methods using the same and uses thereof in the field of wound care, particularly in advanced wound management, more particularly in the application of topical negative pressure (TNP) therapy to a wound site. In particular, but not exclusively, certain embodiments relate to the management of negative pressure loss from a wound dressing intended for covering a wound site whilst TNP therapy is applied.BACKGROUND[0002]Many different types of wound dressing are known, for aiding in the healing process of a human or animal subject in need thereof. These different types of wound dressing include many different types of materials and layers, for example, gauze, pads' and / or foam pads with overlying drapes or multi-layer wound dressings. Advanced wound management dressings are known for the management or healing of complex wounds. Advanced wound management dressings are dressings which are tailored to include specific provision ...

AI Technical Summary

Benefits of technology

The patent describes a wound management kit that includes a negative pressure dressing and a sealant to be applied at a wound site in a fluid-tight manner. The kit can effectively apply the dressing without causing excessive discomfort to the patient, and a pump can be connected to maintain negative pressure at the wound site for an extended period without inefficient power use. The technical effect of this patent is that it offers an efficient and effective way to manage wounds while minimizing discomfort and optimizing the recovery process.

Problems solved by technology

Where hair was present at the application site, this was found to interfere with results and these results were discarded.

In the firstfew minutes the border area had to be continually smoothed down to encourage it to stickdown.As the Mepiseal cured adhesion of the border to the skin improved, however edge lift wasvisible and remained a problem, with significant lift occurring at the dressing corners.Removal of the Mepiseal under the PICO dressing was messy.A4It became apparent that the Mepiseal had not adhered particularly well to the dressingedge.

On removal of the drape the Mepiseal was found to preferentially adhere to the drape allowing clean removal from skin.2. Where Mepiseal was used underneath the border of a PICO dressing it was found that the initial keying of the dressing to the skin was hampered by the presence of the Mepiseal between the skin and the silicone wound contact layer.

Post cure the adhesion of the dressing border to the skin improved and a reduction in loss of negative pressure was recorded, however edge lift was visible and remained a problem.

Cohesive failure was observed as a marked break in the seal during wear.

At break, the silicone on the skin remained adhered and the silicone on the dressing remained adhered, however mechanical failure of silicone bridging these two surfaces was clearly visible.

Cohesive failure was observed as a marked break in the seal during wear.

At break, the silicone on the skin remained adhered and the silicone on the dressing remained adhered, however mechanical failure of silicone bridging these two surfaces was clearly visible.

TABLE 1DIntegrity of Seal and Comments / ObservationsMIComments / ObservationsD1iv-4)Application of the silicone bead improved the seal when compared to the Control,however, large air leaks were recorded by the pump (at 64-65 minutes and110-115 minutes) which required the dressing border to be smoothed down by hand torestore the seal between the skin and the dressing where the Mepiseal had failed.D3iv-5)The cure time of the silicone bead was considered too long for applications where& iv-2)it is on an outer surface.

The bead was smeared in two locations during cure withconcurrent transfer of the silicone onto the opposing contact surfaces.The soft tack of product following cure proved undesirable, the product adhered toclothes and other surfaces that it came into contact with.In one instance where the arm was rested on a hard surface and then moved thiscaused the dressing to lift from the skin along the length of one edge.

The tack ofthe cured Mepiseal therefore presents a potential failure mode when applied to thetop surface of a dressing.Following 2 hours wear, dressing edge lift was observed along one long edge.Along the proximal edge the silicone was seen to have been spread during cureand then suffered cohesive failure post cure at this point.

This was consideredadvantageous for ease of removal.A white colouration was observed on the skin under the product.

Application of the sealant to the skin before application of the dressing was found to be a cumbersome process.

The use of a template (or other method) to ensure accurate topographical application of the sealant coupled with the necessary careful positioning and application of the dressing does not afford an intuitive easy to use process for dressing applications.

Where the sealant can be transferred to other surfaces it reduces the ability of a dressing with a silicone wound contact layer to be applied and then re-positioned without loss of functionality.

In the examples above, whilst many of the variants applied under the wound contact layer reduced the leak rate, they negatively interfered with dressing retention by promoting edge lift.

In summary P2 was found not to be suitable as it readily suffered cohesive failure when applied to the edge of the dressing.

The relatively long cure time and inherent tack of P2 were also undesirable properties for this application.

P1 overcame the problem of cohesive failure but control of this low viscosity product at application was less than optimal for this application.

The material had suitably high viscosity to stop significant flow of the curing silicones during application, however, the cure time was far too long.

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