Catheterization

• US 4,392,848 A
• Filed: 06/25/1979
• Issued: 07/12/1983
• Est. Priority Date: 06/25/1979
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Cooper, Eugene R., Stone, Roger L., Lucas, Donald S.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/051,477
• Time in Patent Office: 1,478 Days
• Field of Search: 128/213 A, 128/213 R, 128/214 R, 128/214.2, 128/214.4, 128/221, 128/348, 128/349, 128/260, 128/1 R, 128/130, 424/317, 424/177
• US Class Current: 604/500
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

At least part of an antimicrobial catheter for use in humans and lower animals comprises a permeable polymer. The polymer must be in contact with both the environment external to the catheter and with a liquid reservoir of antimicrobial agent flowing through the lumen of the catheter, said liquid reservoir comprising an aqueous solution containing at least a minimum lethal concentration of a straight-chain carboxylic acid or carboxylic acid salt having from 4 to 9 carbon atoms. In use, the antimicrobial agent diffuses from the liquid reservoir through the polymer and provides a zone of microbial inhibition around the external surface of the catheter. The invention thus prevents nosocomial infections resulting from the use of catheters by inhibiting microorganisms at and around the placement site of the catheter when the catheter is inserted into the body of a human or lower animal.

Claims

1. A method for catheterization with lowered risk of nosocomial infection by achieving microbial inhibition at and around the placement site of catheters and the like used in the bodies of humans and lower animals, comprising:

inserting into the body of a human or lower animal in need of such treatment a catheter, or the like, said catheter comprising;

a liquid reservoir of antimicrobial agent;

a delivery means for transporting liquid materials, said delivery means being in the form of a tube;

at least part of the portion of said tube which contacts the body comprising a carboxylic acid-permeable polymer, said polymer being in contact with both the environment external to said catheter and with said reservoir of antimicrobial agent flowing within the lumen of said catheter;

said reservoir of antimicrobial agent comprising an aqueous solution containing at least a minimum lethal concentration of a straight chain carboxylic acid or carboxylic acid salt having from 4 to 9 carbon atoms.

2. A method according to claim 1 wherein the solution passing through the catheter has a flow rate of from about 1 ml/hr to about 1000 ml/hr.

3. A method according to claim 1 wherein said polymer portion of said catheter has a thickness of from about 0.05 mm. to about 2.5 mm.

4. An article according to claim 1 wherein the carboxylic acid or carboxylic acid salt is present in solution in a concentration of from about 100 μ

M to about 1 M.

5. A method according to claim 4 wherein the carboxylic acid or carboxylic acid salt is selected from the group consisting of n-octanoic acid, n-hexanoic acid and their pharmaceutically-acceptable salts, and mixtures thereof.

6. A method according to claim 5 wherein the free hexanoic acid is present in solution in a concentration of at least 30 mM, or the free octanoic acid is present in solution in a concentration of at least 3.5 mM.

7. A method according to claim 4 wherein the solution has a pH of from about 3.5 to about 6.0.

8. An article of manufacture especially adapted for use as a catheter or the like, in the bodies of humans or lower animals, comprising:

an aqueous liquid reservoir of antimicrobial agent;

a tube for transporting liquid materials, at least a part of the portion of said tube which contacts the body comprising carboxylic acid-permeable polymer, said polymer being in contact with both the environment external to said catheter and with said aqueous liquid reservoir of antimicrobial agent flowing within the lumen of said catheter;

said reservoir of antimicrobial agent comprising an aqueous solution containing at least a minimum lethal concentration of a straight chain carboxylic acid or carboxylic acid salt having from 4 to 9 carbon atoms.

9. An article according to claim 8 wherein the carboxylic acid or carboxylic acid salt is present in solution in a concentration of from about 100 μ

M to about 1 M.

10. An article according to claim 9 wherein the solution of antimicrobial has a pH of from about 3.5 to about 6.0.

11. An article according to claim 9 wherein the carboxylic acid or carboxylic acid salt is selected from the group consisting of octanoic acid, hexanoic acid, and their pharmaceutically-acceptable salts, and mixtures thereof.

12. An article according to claim 10 wherein the free hexanoic acid is present in solution in a concentration of at least 30 mM, or the free octanoic acid is present in solution in a concentration of at least 3.5 mM.

13. An article according to claim 8 wherein the carboxylic acid-permeable polymer portion of the wall of the tube has a thickness of from about 0.05 mm. to about 2.5 mm.

14. An article according to claim 8 wherein the carboxylic acid-permeable polymer is a silicone elastomer.

15. An article according to claim 14 wherein the silicone elastomer is polydimethylsiloxane.

16. An article according to claim 8 wherein the carboxylic acid-permeable polymer is polyethylene.

17. An article according to claim 8 wherein the carboxylic acid-permeable polymer is silicone-urethane copolymer.

18. An article according to claim 8 wherein the carboxylic acid-permeable polymer is ethylene-propylene copolymer.

19. An article according to claim 8 wherein the carboxylic acid-permeable polymer is polyurethane.

20. An article according to claim 8 wherein the carboxylic acid-permeable polymer is polypropylene.