IP Library Granted Patent US 12,447,188
Granted Patent B2
US 12,447,188 · App. 16/900,863 · Granted Oct 21, 2025

Compositions and methods for the antiseptic treatment of biofilms on mammalian tissue

Inventor: Stephen Thomas Woody (Asheville, NC)
Assignee: Avadim Holdings, Inc.
A61K36/886A61K9/0053A61K31/4166A61K47/02A61K47/10A61K47/12A61K47/183A61K47/186A61K47/22A61K47/24A61K47/26A61K47/34A61P31/02
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Quick Facts
Patent No.
US 12,447,188
App. No.
16/900,863
Granted
Oct 21, 2025
Kind
B2
Abstract

Compositions and methods for providing the hybrid benefit of treating biofilms on the surface of mammalian tissue, especially biofilms that occur in association with chronic wounds and burns, and simultaneously providing an antiseptic cleansing and maintenance of the stratum corneum of the tissue and other tissue surfaces, and an opportunity for the tissue to improve by engaging its own natural barrier and immunological defense properties. The compositions and methods prevent the re-establishment of biofilms by facilitating the reduction or eradication of the pathogen producing the biofilm before the biofilm can be established.

Claims (10)

1. A composition for treating the surface of inflamed chronically infected mammalian tissue, consisting of:

at least one ingredient selected from each of the following categories: an amphoteric surfactant category (a) ingredient having a wt % from about 2.0 to about 8.0 wt. %, a skin compatible anti-inflammatory category (b) ingredient having a wt % from about 6.0 to about 12.0 wt. %, and a skin compatible anti-foaming category (c) ingredient having a wt % from about 0.19 to about 0.27 wt. %;

at least one ingredient selected from each of the following categories: a cell growth promoting category (d) ingredient having a wt % from about 4.0 to about 10.0 wt. %, an immune system enhancing category (e) ingredient having a weight percentage from about 2.0 to about 5.0 wt. %, a fast acting skin compatible antimicrobial category (f) ingredient having a weight percentage from about 2.0 to about 10.0 wt. %, an absorption facilitation category (g) ingredient having a weight percentage from about 0.5 to about 5.0 wt. %, a humectant and emollient category (h) ingredient having a weight percentage from about 2.0 to about 11.0 wt. %, a free radical scavenging category (i) ingredient having a weight percentage from about 4.0 to about 8.0 wt. %, and a healing promoting category (j) ingredient having a weight percentage from about 2.0 to about 4.0 wt. %;

a biocompatible preservative category (k) ingredient of potassium sorbate having a weight percentage from about 0.01 to about 0.10 wt. %; and a plant based extract category (l) ingredient of olibanum (frankensense) having a weight percentage from about 0.009 wt. % to about 5.0 wt. %; with the balance of the composition being approximately 70 to 90 wt. % water;

wherein the composition has an acidic pH of from 4.0 to 5.0, is gamma irradiated at 4 kGY to 35 kGY to a sterility assurance level of 10 −2 to 10 −6 , and provides the hybrid benefits of: (1) treating microbials, (2) treating biofilms, (3) maintaining, nourishing and moisturizing, (4) maintaining the natural pH; (5) maintaining and promoting immunocompetency, and (6) protecting and preserving barrier function of the tissue's stratum corneum.

2. The composition of claim 1 wherein the category (a) ingredient is selected from the group consisting of cocamidopropyl betaine, cocamidopropyl hydroxysultaine, betaine alkyl glucosides, laurylglucosides, and combinations thereof; the category (b) ingredient is selected from the group consisting of aloe vera, allantoin, cocamidopropyl betaine, and mixtures thereof; the category (c) ingredient is selected from the group consisting of silicone-based antifoaming agents, dimethicone copolyol; the category (d) ingredient is selected from the group consisting of aloe vera, allantoin, beta glucan, a bioflavonoid, a polyphenolic compound, a grapefruit derived quaternary compound, and mixtures thereof; the category (e) ingredient is selected from the group consisting of aloe vera, beta glucan, colloidal silver, allantoin and mixtures thereof; the category (f) ingredient is selected from the group consisting of hepar sulphuris, camphor calcareum, xylitol, polyglyceryl-2-laurate, octenidine hydrochloride, Eucalyptus globulus , colloidal silver, a bioflavonoid, a polyphenolic compound, a grapefruit derived quaternary compound, grapefruit extract, and mixtures thereof; the category (g) ingredient is selected from the group consisting of beta glucan, aloe vera, colloidal silver, and mixtures thereof; the category (h) ingredient is selected from the group consisting of aloe vera, vitamin E, cocamidopropyl betaine, glycerin, fructooligosaccharides, decyl glucoside, diglycerin, Beta vulgaris root extract and mixtures thereof; the category (i) ingredient is selected from the group consisting of a bioflavonoid, a polyphenolic compound, a grapefruit derived quaternary compound, beta glucan, allantoin, vitamin E, Lactococcus ferment lysate, and mixtures thereof; the category (j) ingredient is selected from the group consisting of aloe vera, allantoin, beta glucan, and mixtures thereof.

3. The composition of claim 2 , wherein the composition does not contain grapefruit derived quaternary compounds.

4. The composition of claim 2 , wherein the composition does not contain a beta glucan.

5. The composition of claim 1 as a foam.

6. The composition of claim 1 as a spray.

Assignments (3)
BILL OF SALE Recorded Apr 21, 2023
From: AVADIM HEALTH, INC.
To: AVADIM HOLDINGS, INC.
Reel/Frame 063423/0818 →
CHANGE OF NAME Recorded Sep 16, 2022
From: AVADIM HEALTH, INC.
To: AVADIM HEALTH IP, INC.
Reel/Frame 061116/0906 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 9, 2022
From: WOODY, STEPHEN T.
To: AVADIM HEALTH, INC.
Reel/Frame 061049/0281 →
Continuity (2)
Provisional Application 62860727 · Jun 12, 2019
Related Publication 20210244785A1 · Aug 12, 2021
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