IP Library Granted Patent US 11,925,768
Granted Patent B2
US 11,925,768 · App. 16/054,017 · Granted Mar 12, 2024

Method for decolonizing mammalian skin

Inventor: Stephen T. Woody (Asheville, NC)
Assignee: AVADIM HEALTH IP, INC.
A61M25/0017A61L2/0088A61M2025/0019A61M2025/0056A61M2210/14A61M2210/16
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Quick Facts
Patent No.
US 11,925,768
App. No.
16/054,017
Granted
Mar 12, 2024
Kind
B2
Abstract

A method for insertion, maintenance, and removal of urethral catheters in mammals including humans includes steps for preventing or reducing the incidence of catheter associated urinary tract infections. In addition to sterile procedures currently practiced or as may be practiced in the future in connection with catheter use, the method includes the steps of applying an antiseptic, zwitterionic, and acidic skincare solution capable of preserving the stratum corneum to the perineum, meatus, and contiguous mucosa surrounding the insertion site before insertion, after insertion, periodically during the period of indwelling, in connection with any incidence of incontinence, and, optionally, before and after removal of the catheter. Application of the solution optionally is continued after catheter removal on a periodic basis until the threat of an infection associated with catheter use has passed, typically at least about five (5) to seven (7) days and up to thirty (30) days. The solution pH is desirably from about 4.4 to 5.5.

Claims (36)

1. A method for reducing the spread of infectious agents among mammals, including MRSA, VRE, and CRE, by topically bathing the mammal's skin tissue, the skin tissue comprising the stratum corneum outermost layer and having a barrier function, with a non-antibiotic, zwitterionic, mildly acidic, antiseptic solution to support the barrier function of the stratum corneum, the method comprising the steps of:

a. bathing a perineum of a mammal's skin with a topically applied antiseptic solution that is non-antibiotic and zwitterionic, has a pH of from about 4.0 to 6.5, does not require rinsing, and has properties of supporting the barrier function of the stratum corneum skin tissue; wherein the solution of subpart (a) is an aqueous composition comprising at least one surfactant, at least one anti-inflammatory agent, at least one non-foaming agent, at least one cell growth promoting agent, at least one fast acting antimicrobial agent, and at least one different ingredient selected from the group consisting of immune system enhancing agents, absorption facilitating agents, humectants and emollients, free radical scavenging agents, and healing promoting agents;

b. topically applying the solution to exterior portions of a catheter before insertion into the mammal;

c. inserting the catheter;

d. repeating step (a) every 4 to 12 hours to reduce the opportunity for infection; whereby the mammal is decolonized of infectious agents and the risk of transmission is reduced; and

e. wiping the perineum with the solution after removal of the catheter.

2. The method of claim 1 wherein the solution of subpart (a) comprises citrus-based antimicrobial stabilizers, zwitterionic surfactants with quaternary ammonium ions, and colloidal silver.

3. The method of claim 1 wherein the solution of subpart (a) has a pH of from about 4.4 to 5.5.

4. The method of claim 1 wherein step (a) is repeated about every 4 to 8 hours.

5. The method of claim 1 wherein step (a) is repeated about every 6 to 8 hours.

6. The method of claim 1 wherein step (a) is repeated after each incidence of incontinence or other contamination, whereby the mammal is decolonized of infectious agents and the risk of transmission is reduced.

7. The method of claim 1 wherein the skin tissue further comprises one or more of the meatus, mucosa, wounds, infected areas, and combinations thereof.

8. A method for reducing the spread of infectious agents, including MRSA, VRE, and CRE, by topically bathing the mammal's skin tissue, the skin tissue comprising the stratum corneum outermost layer and having a barrier function, with a non-antibiotic, zwitterionic, mildly acidic, antiseptic solution to support the barrier function of the stratum corneum, the method comprising the steps of:

a. bathing a perineum of a mammal's skin with a topically applied antiseptic solution that is non-antibiotic and zwitterionic, has a pH of from about 4.0 to 5.5, and has properties of supporting the barrier function of the stratum corneum skin tissue; wherein the solution of subpart (a) is an aqueous composition comprising at least one surfactant, at least one anti-inflammatory agent, at least one non-foaming agent, at least one cell growth promoting agent, at least one fast acting antimicrobial agent, and at least one different ingredient selected from the group consisting of immune system enhancing agents, absorption facilitating agents, humectants and emollients, free radical scavenging agents, and healing promoting agents;

b. topically applying the solution to exterior portions of a catheter before insertion into the mammal;

c. inserting the catheter;

d. repeating step (a) about every 4 to 8 hours to reduce the opportunity for infection;

e. repeating step (d) after each incidence of incontinence or other contamination; whereby the mammal is decolonized of infectious agents and the risk of transmission is reduced; and

f. wiping the perineum with the solution after removal of the catheter.

9. The method of claim 8 wherein the solution of subpart (a) comprises citrus-based antimicrobial stabilizers, zwitterionic surfactants with quaternary ammonium ions, and colloidal silver.

10. The method of claim 8 wherein the solution of subpart (a) has a pH of from about 4.4 to 5.5.

11. The method of claim 8 wherein the skin tissue further comprises one or more of the meatus, mucosa, wounds, infected areas, and combinations thereof.

12. A method for decolonizing a mammal of infectious agents by topically applying a non-antibiotic, zwitterionic, mildly acidic, antiseptic solution the mammal's skin, the skin comprising one or more of the stratum corneum, perineum, meatus, mucosa, wounds, infected areas, and combinations thereof, the method comprising the steps of:

(a) topically applying to a perineum of the mammal's skin an antiseptic solution that is non-antibiotic and zwitterionic, has a pH of from about 4.0 to 6.5, does not require rinsing, and has properties of supporting the barrier function of stratum corneum skin tissue; wherein the solution is an aqueous composition comprising at least one surfactant, at least one anti-inflammatory agent, at least one non-foaming agent, at least one cell growth promoting agent, at least one fast acting antimicrobial agent, and at least one different ingredient selected from the group consisting of immune system enhancing agents, absorption facilitating agents, humectants and emollients, free radical scavenging agents, and healing promoting agents; wherein the solution comprises citrus-based antimicrobial stabilizers, zwitterionic surfactants with quaternary ammonium ions, and colloidal silver and has a pH of from about 4.4 to 5.5;

(b) topically applying the solution to exterior portions of a catheter before insertion into the mammal;

(c) inserting the catheter;

(d) repeating step (a) every 4 to 12 hours to reduce the opportunity for infection; whereby the mammal is decolonized of infectious agents; and

(e). wiping the perineum with the solution after removal of the catheter.

13. The method of claim 12 wherein step (a) is repeated about every 4 to 8 hours to about every 6 to 8 hours and after each incidence of incontinence or other contamination, whereby the mammal is decolonized of infectious agents and the risk of transmission is reduced.

14. A method for reducing the spread of infectious agents, including MRSA, VRE, and CRE, by topically bathing the mammal's skin tissue, the skin tissue comprising the stratum corneum outermost layer and having a barrier function, the skin tissue for bathing further comprising one or more of the perineum, meatus, mucosa, wounds, infected areas, and combinations thereof, with a non-antibiotic, zwitterionic, mildly acidic, antiseptic solution to support the barrier function of the stratum corneum, the method comprising the steps of:

a. bathing a perineum of the mammal's skin with a topically applied antiseptic solution that is non-antibiotic and zwitterionic, has a pH of from about 4.0 to 5.5, and has properties of supporting the barrier function of the stratum corneum skin tissue; wherein the solution of subpart (a) is an aqueous composition comprising at least one surfactant, at least one anti-inflammatory agent, at least one non-foaming agent, at least one cell growth promoting agent, at least one fast acting antimicrobial agent, and at least one different ingredient selected from the group consisting of immune system enhancing agents, absorption facilitating agents, humectants and emollients, free radical scavenging agents, and healing promoting agents; wherein the solution comprises citrus-based antimicrobial stabilizers, zwitterionic surfactants with quaternary ammonium ions, and colloidal silver and has a pH of from about 4.4 to 5.5;

b. topically applying the solution to exterior portions of a catheter before insertion into the mammal;

c. inserting the catheter;

d. repeating step (a) about every 4 to 8 hours to reduce the opportunity for infection;

e. repeating step (d) after each incidence of incontinence or other contamination; whereby the mammal is decolonized of infectious agents and the risk of transmission is reduced; and

e. wiping the perineum with the solution after removal of the catheter.

Assignments (6)
BILL OF SALE Recorded Apr 21, 2023
From: AVADIM HEALTH, INC.
To: AVADIM HOLDINGS, INC.
Reel/Frame 063423/0818 →
PATENT SECURITY AGREEMENT Recorded Jun 2, 2021
From: AVADIM HEALTH IP, INC.; AVADIM HEALTH, INC.
To: HAYFIN SERVICES LLP, AS COLLATERAL AGENT
Reel/Frame 056461/0660 →
SECURITY INTEREST Recorded Mar 14, 2019
From: AVADIM HEALTH IP, INC.
To: HAYFIN SERVICES LLP, AS COLLATERAL AGENT
Reel/Frame 048598/0381 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2019
From: AVADIM HEALTH, INC.
To: AVADIM HEALTH IP, INC.
Reel/Frame 048391/0212 →
CHANGE OF NAME Recorded Jan 17, 2019
From: AVADIM TECHNOLOGIES, INC.
To: AVADIM HEALTH, INC.
Reel/Frame 048090/0699 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2018
From: WOODY, STEPHEN THOMAS
To: AVADIM TECHNOLOGIES, INC.
Reel/Frame 046550/0305 →
Continuity (4)
Continuation 14629320 · Feb 23, 2015
Provisional Application 62082019 · Nov 19, 2014
Provisional Application 61943287 · Feb 21, 2014
Related Publication 20180344972A1 · Dec 6, 2018