IP Library Granted Patent US 10,046,137
Granted Patent B2
US 10,046,137 · App. 14/629,320 · Granted Aug 14, 2018

Method for maintenance of urethral catheters

Inventor: Stephen Thomas Woody (Asheville, NC)
Assignee: AVADIM TECHNOLOGIES, INC.
A61M25/0017A61L2/0088A61M2025/0019A61M2025/0056A61M2210/14A61M2210/16
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Quick Facts
Patent No.
US 10,046,137
App. No.
14/629,320
Granted
Aug 14, 2018
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 (21)

1. A method for reducing the incidence of catheter associated urinary tract infections (CAUTI's) of the type acquired as a result of the use of an indwelling urinary catheter and in which a urinary catheter is inserted into a mammalian urethra thereby to define a urethral insertion site, the site having an indwelling urinary catheter, the indwelling urinary catheter characterized by an inserted catheter portion and an exposed catheter portion, the urethral insertion site defined by stratum corneum skin tissue having a barrier function and comprising a meatus, a surrounding perineum, and contiguous mucosa between the meatus and perineum, the method comprising the steps of:

a. wiping the perineum, meatus, and contiguous mucosa surrounding a mammalian urethra for a urinary catheter insertion site with an antiseptic solution that is non-antibiotic and zwitterionic, has a pH of from about 4.4 to 5.5 and has properties of supporting the barrier function of stratum corneum skin tissue defining the insertion site;

b. wiping the catheter with a solution of subpart (a);

c. inserting the catheter wiped in accordance with step (b) into the urethra so as to define an indwelling catheter having an inserted catheter portion and an exposed catheter portion;

d. wiping the exposed catheter portion of the indwelling catheter along with the perineum, meatus, and contiguous mucosa surrounding the insertion site immediately after step (c) of inserting the catheter and in a downward direction with the solution of subpart (a);

e. wiping the exposed catheter portion and the perineum, meatus, and contiguous mucosa surrounding the insertion site periodically at least every 12 hours for an entire period of indwelling of the catheter with the solution of subpart (a);

f. determining when the catheter is to be removed;

g. wiping the perineum, meatus, and contiguous mucosa surrounding the insertion site with the solution of subpart (a) immediately prior to catheter removal;

h. removing the catheter following step (g); and

i. wiping the perineum, meatus, and contiguous mucosa surrounding the insertion site with the solution of subpart (a) immediately after catheter removal.

2. The method of claim 1 further comprising wiping the meatus with a povidone-iodine solution before inserting the catheter in accordance with step (c).

3. 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.

4. The method of claim 1 wherein the solution of subpart (a) has a pH of from about 4.7 to 5.5.

5. The method of claim 1 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.

6. The method of claim 1 in which the wiping step (e) is repeated about every 6 to 8 hours.

7. The method of claim 1 wherein the wiping step (e) is repeated about every 4 hours.

8. The method of claim 1 further comprising the step of, after removing the catheter wiping the perineum, meatus, and contiguous mucosa surrounding the insertion site with the solution of subpart (a) at an interval of about every 6 to 12 hours during a period of about 5 days to up to a month.

9. The method of claim 8 wherein the step of wiping the perineum, meatus, and contiguous mucosa surrounding the insertion site with the solution of subpart (a) after removing the catheter is repeated about every 6 to 12 hours for from about 5 to 7 days.

10. The method of claim 8 wherein steps (a) through (i) are performed in a health care setting and the method further comprises the step after step (i) of providing a kit for home care for wiping the perineum, meatus, and contiguous mucosa surrounding the insertion site with the solution of subpart (a) after removing the catheter.

11. The method of claim 1 further comprising repeating step (e) after an incidence of incontinence or other contamination.

12. The method of claim 1 wherein step (e) is repeated every 4 hours in the event of the occurrence of risk factors.

Assignments (8)
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 →
RELEASE OF SECURITY INTEREST Recorded Oct 5, 2018
From: MK INTERNATIONAL INVESTMENTS SUBSIDIARY 1, LLC, AS COLLATERAL AGENT
To: AVADIM HEALTH, INC. (F/K/A AVADIM TECHNOLOGIES, INC.)
Reel/Frame 047082/0797 →
SECURITY INTEREST Recorded Apr 11, 2018
From: AVADIM TECHNOLOGIES; RELION MANUFACTURING, INC.; QUALITY ASSURANCE ASSOCIATES, INC.; BIONOME PROPERTIES CORP.
To: MK INTERNATIONAL INVESTMENTS SUBSIDIARY 1, LLC
Reel/Frame 045510/0972 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 11, 2017
From: WOODY, STEPHEN THOMAS
To: AVADIM TECHNOLOGIES, INC.
Reel/Frame 042975/0896 →
Continuity (3)
Provisional Application 61943287 · Feb 21, 2014
Provisional Application 62082019 · Nov 19, 2014
Related Publication 20150343172A1 · Dec 3, 2015
Cited By (1)
US 12,447,188