Antimicrobial silicone-based wound dressings

Inventors

Yang, LiuDiTizio, Valerio

Assignees

Covalon Technologies Ltd

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Publication Number

US-10500173-B2

Patent

Publication Date

2019-12-10

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

The invention relates to an antimicrobial silicone-based wound dressing in the form of a transparent and self-adhesive gel sheet cured from a liquid containing silicone. The cured gel sheet is formed of a crosslinked silicone elastomer with sufficient crosslinking between silicone polymer chains to provide a cohesively strong gel sheet, enabling application and subsequent removal from a wound site or surgical site on a patient while leaving substantially no residue. The gel sheet contains from 95 wt % to 98 wt % of the crosslinked silicone elastomer, with components evenly dispersed throughout.

Antimicrobial activity is provided by evenly dispersed solid particulates of chlorhexidine diacetate that is not soluble in the silicone-containing liquid, together with chlorhexidine digluconate and a silver agent. The total amount of chlorhexidine present in the cured gel sheet is from 2 wt % to 5 wt %, and the amount of the silver agent is from 0.025 wt % to 0.5 wt %. The silver agent is photo-stabilized with a compound containing a basic nitrogen atom to complex with the silver and a dye.

The dressing is documented as maintaining transparency, tackiness/elasticity, and antimicrobial activity over a treatment period, with gradual release kinetics for chlorhexidine and silver. The antimicrobial activity is stated over 7 days against MRSA, VRE, P. aeruginosa, C. albicans, and S. epidermidis. An optional moisture-permeable breathable backing and specific dressing formats are also described, including use as an IV catheter site dressing/device for infection-prevention purposes.

Claims Coverage

The patent includes two independent claims. The inventive features are focused on a transparent self-adhesive crosslinked silicone gel sheet with substantially no residue removal and specified chlorhexidine/silver antimicrobial components, including photo-stabilization, and, for the second independent claim, a moisture vapor permeable backing layer.

Transparent self-adhesive crosslinked silicone gel sheet with minimal residue removal

A transparent and self-adhesive gel sheet cured from a liquid containing silicone and formed for adhesion to a wound site or surgical site on a patient, wherein the cured gel sheet is formed of a crosslinked silicone elastomer having sufficient crosslinking between silicone polymer chains so that the gel sheet is cohesively strong thereby allowing for application and subsequent removal from the wound site or surgical site while leaving substantially no residue, the cured gel sheet having from 95 wt % to 98 wt % of the crosslinked silicone elastomer and having evenly dispersed antimicrobial components throughout.

Chlorhexidine diacetate particulates with chlorhexidine digluconate and photo-stabilized silver plus dye

The gel sheet further includes solid particulates of chlorhexidine diacetate that is not soluble in said liquid, together with chlorhexidine digluconate, and a silver agent, the silver agent photo-stabilized with a compound containing a basic nitrogen atom to complex with the silver and a dye, wherein the total amount of chlorhexidine present in the cured gel sheet is from 2 wt % to 5 wt %, and the amount of the silver agent present in the cured gel sheet is from 0.025 wt % to 0.5 wt %.

Moisture vapor permeable backing layer with non-adhesive underside

A non-adhesive, moisture vapor permeable backing layer layered on a bottom surface of the cured gel sheet, with the top surface of the cured gel sheet able to adhere to the skin of a subject without any additional adhesive.

Across the independent claims, the inventive coverage centers on a transparent, self-adhesive, cohesively strong crosslinked silicone gel sheet capable of substantially no residue removal, formulated with evenly dispersed chlorhexidine diacetate particulates, chlorhexidine digluconate, and a photo-stabilized silver agent complexed with a basic nitrogen compound and a dye, with specified chlorhexidine and silver wt% ranges; one claim additionally requires a non-adhesive moisture vapor permeable backing layer.

Stated Advantages

Application and subsequent removal from a wound site or surgical site while leaving substantially no residue.

Cohesively strong gel sheet enabling adherence as a transparent self-adhesive dressing.

Maintained transparency over the stated period, with gradual release kinetics for chlorhexidine and silver and antimicrobial activity over 7 days.

Documented Applications

Wound site or surgical site dressing on a patient.

IV catheter site dressings/device use as a protective dressing for infection-prevention purposes.

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