Triclosan-containing medical devices

• US 5,772,640 A
• Filed: 01/05/1996
• Issued: 06/30/1998
• Est. Priority Date: 01/05/1996
• Status: Expired due to Fees

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Modak, Shanta, Sampath, Lester
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/583,239
• Time in Patent Office: 907 Days
• Field of Search: 604/265, 604/264, 428/35.7, 428/36.9, 606/76, 424/422, 623/1
• US Class Current: 604/265
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/202 with halogen atoms, e.g. triclosan, povidone-iodine
• CPC Class Codes: A61L 2300/206 Biguanides, e.g. chlorohexidine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10T 428/1331 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]

Abstract

The present invention relates to polymeric medical articles contained the antiinfective agents chlorhexidine and triclosan. It is based, at least in part, on the discovery that the synergistic relationship between these compounds permits the use of relatively low levels of both agents, and on the discovery that effective antimicrobial activity may be achieved when these compounds are contained in either hydrophilic or hydrophobic polymers.

Claims

1. A hydrophilic polymeric medical article which has been impregnated, coated, or impregnated and coated with a treatment solution comprising (i) between about 1 and 10 percent of a hydrophilic polymer;

(ii) between 1 and 5 percent of an antiinfective agent selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, and a chlorhexidine derivative; and

(iii) between 0.5 and 5 percent of triclosan.

2. The medical article of claim 1 which is fabricated from a hydrophilic polymer selected from the group consisting of natural rubber latex and biomedical polyurethane.

3. The medical article of claim 1 wherein the hydrophilic polymer in the treatment solution is a biomedical polyurethane.

4. The medical article of claim 2 wherein the hydrophilic polymer in the treatment solution is a biomedical polyurethane.

5. A hydrophilic polymeric medical article which has been impregnated, coated, or impregnated and coated with a treatment solution comprising (i) between about 1 and 10 percent of a hydrophobic polymer (ii) between 1 and 5 percent of an antiinfective agent selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, and a chlorhexidine derivative;

and (iii) between 0.5 and 5 percent of triclosan.

6. The medical article of claim 5, further comprising silver sulfadiazine.

7. The medical article of claim 6 wherein the hydrophobic polymer is a biomedical silicone polymer.

8. The medical article of claim 6 wherein the hydrophobic polymer is a silicone-polyurethane copolymer.

9. The medical article of claim 5 which is a catheter.

10. The catheter of claim 9 which is an intravenous catheter.

11. The catheter of claim 10 which is fabricated from a biomedical polyurethane.

12. The catheter of claim 11 wherein the hydrophobic polymer in the solution is a biomedical silicone-polyurethane copolymer.

13. The medical article of claim 5 which is fabricated from a hydrophilic polymer selected from the group consisting of natural rubber latex and biomedical polyurethane.

14. The medical article of claim 13 wherein the hydrophobic polymer in the treatment solution is a biomedical silicone polymer.

15. The medical article of claim 13 wherein the hydrophobic polymer in the treatment solution is a silicone-polyurethane copolymer.

16. The medical article of claim 5 wherein the hydrophobic polymer in the treatment solution is a biomedical silicone polymer.

17. The medical article of claim 5 wherein the hydrophobic polymer in the treatment solution is a silicone-polyurethane copolymer.

18. A hydrophobic polymeric medical article which has been impregnated, coated, or impregnated and coated with a treatment solution comprising (i) between about 1 and 10 percent of a hydrophobic polymer (ii) between 1 and 5 percent of an antiinfective agent selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, and a chlorhexidine derivative;

and (iii) between 0.5 and 5 percent of triclosan.

19. The medical article of claim 18 which is fabricated from a hydrophobic polymer selected from the group consisting of polytetrafluoroethylene, Dacron, which is a polyethylene terephthalate polyvinylchloride, biomedical silicone polymer, and silicone polyurethane copolymer.

20. The medical article of claim 19 wherein the hydrophobic polymer in the treatment solution is a biomedical silicone polymer.

21. The medical article of claim 19 wherein the hydrophobic polymer in the treatment solution is a silicone-polyurethane copolymer.

22. The medical article of claim 18 wherein the hydrophobic polymer in the treatment solution is a biomedical silicone polymer.

23. The medical article of claim 18 wherein the hydrophobic polymer in the treatment solution is a silicone-polyurethane copolymer.

24. A method for rendering a silicone catheter antiinfective, comprising:

(1) placing the silicone catheter in an impregnating solution comprising (a) a solvent which causes the catheter to swell;

(b) between 1 and 5 percent of an antiinfective agent selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, and a chlorhexidine derivative;

(c) between 0.5 and 5 percent of triclosan; and

(d) between 1 and 10 percent of a biomedical polymer;

(2) soaking the catheter in the impregnating solution for a period of time sufficient to allow the catheter to swell;

(3) removing the catheter from the impregnating solution; and

(4) drying the catheter.

25. The method of claim 24, wherein the biomedical polymer is a biomedical silicone polymer.

26. The method of claim 24, further comprising the step of dipping the catheter, after drying according to step (4), into a second coating solution comprising a biomedical polymer.

27. The method according to claim 26, wherein the biomedical polymer in both the impregnating solution and the second coating solution is a biomedical silicone polymer.

28. A hydrophobic polymeric medical article which has been impregnated, coated, or impregnated and coated with a treatment solution comprising (i) between about 1 and 10 percent of a hydrophilic polymer;

(ii) between 1 and 5 percent of an antiinfective agent selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, and a chlorhexidine derivative; and

(iii) between 0.5 and 5 percent of triclosan.

29. The medical article of claim 28 which is fabricated from a hydrophobic polymer selected from the group consisting of polytetrafluoroethylene, Dacron, which is a polyethylene terephthalate polyvinylchloride, biomedical silicone polymer, and silicone polyurethane copolymer.

30. The medical article of claim 28 wherein the hydrophilic polymer is a biomedical polyurethane.