Antimicrobial silicone-based wound dressings
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Publication Number
US-10933035-B2
Publication Date
2021-03-02
Expiration Date
Abstract
Antimicrobial silicone-based dressings, such as wound dressings, are disclosed. An example dressing comprises a transparent and self-adhesive gel sheet cured from a liquid containing silicone, the sheet having dispersed therein (i) particulates of a chlorhexidine compound that is not soluble in the liquid; and (ii) at least one other antimicrobial. Methods of making the silicone-based dressings and methods of use are also disclosed.
Core Innovation
A molded, cured self-adhesive silicone gel sheet is formed of a generally uniform material in which a crosslinked silicone elastomer provides the structural support and is sufficiently crosslinked between silicone polymer chains to provide cohesive strength for application and removal with minimal residue. The gel sheet composition includes from 95 wt % to 98 wt % of the crosslinked silicone elastomer, and the gel sheet has a top surface formed of and made adherent by the crosslinked silicone elastomer so the dressing adheres to the skin of a subject without any additional adhesive.
Solid particulates of chlorhexidine diacetate that are not soluble in the liquid from which the gel sheet is formed are evenly dispersed throughout the crosslinked silicone elastomer, at a concentration that does not disrupt crosslinking between silicone polymer chains. The total amount of chlorhexidine present in the material is from 2 wt % to 5 wt %, optionally including chlorhexidine digluconate together with a photostabilized silver agent.
A photostabilized silver agent is provided that is photo-stabilized with a compound containing a basic nitrogen atom to complex with silver and a dye. The dressing maintains transparency while inhibiting microbial growth in a wound for at least 7 days, while also enabling antimicrobial action through the combination of chlorhexidine and the photostabilized silver system.
Claims Coverage
The independent claims define a self-adhesive antimicrobial silicone gel-sheet dressing with four inventive features: a crosslinked silicone elastomer matrix, evenly dispersed non-soluble chlorhexidine particulates at a specified total chlorhexidine level, a photostabilized silver agent system, and transparency while inhibiting microbial growth in a wound for at least 7 days.
Molded cured self-adhesive silicone gel sheet with crosslinked silicone elastomer structural support
A dressing comprising a molded, cured self-adhesive silicone gel sheet formed of a generally uniform material, the gel sheet formed of from 95 wt % to 98 wt % of a crosslinked silicone elastomer, the silicone elastomer acting as the structural support of the dressing, and the gel sheet having a top surface formed of and made adherent by the crosslinked silicone elastomer to allow the dressing to adhere to the skin of a subject without any additional adhesive.
Evenly dispersed solid chlorhexidine diacetate particulates that do not disrupt crosslinking
The gel sheet having evenly dispersed throughout the crosslinked silicone elastomer solid particulates of chlorhexidine diacetate not soluble in a liquid from which the gel sheet is formed, at a concentration so as not to disrupt crosslinking between silicone polymer chains in the silicone elastomer, wherein the total amount of chlorhexidine present in the material is from 2 wt % to 5 wt %.
Photostabilized silver agent with basic nitrogen complexing compound and dye
The dressing comprising a photostablized silver agent, or chlorhexidine digluconate and a photostabilized silver agent, wherein the photo-stabilized silver agent is photo-stabilized with a compound containing a basic nitrogen atom to complex with silver and a dye.
Transparency while inhibiting microbial growth in a wound for at least 7 days
The dressing maintaining transparency while inhibiting microbial growth in a wound for at least 7 days.
Across the independent claims, the coverage centers on a molded cured self-adhesive silicone gel sheet where a sufficiently crosslinked silicone elastomer provides structural support and skin adhesion without added adhesive, while non-soluble chlorhexidine diacetate particulates are dispersed without disrupting crosslinking at a total chlorhexidine level of 2 wt % to 5 wt %. Antimicrobial scope further requires a photostabilized silver agent whose photo-stabilization is achieved using a basic-nitrogen complexing compound together with a dye, and the dressing maintains transparency while inhibiting microbial growth for at least 7 days.
Stated Advantages
Allows the dressing to adhere to skin of a subject without any additional adhesive.
Provides sufficient cohesive strength to allow application and removal while leaving minimal residue on the surface.
Maintains transparency for wound visualization while inhibiting microbial growth in a wound for at least 7 days.
Documented Applications
Wound dressing configured to inhibit microbial growth in a wound while maintaining transparency for at least 7 days.
I.V. dressing.
Wound barrier.
Strip.
First aid bandage.
Surgical drape.
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