Triclosan-containing medical devices

• US 6,706,024 B2
• Filed: 12/22/2000
• Issued: 03/16/2004
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• 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 M., Sampath, Lester A.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/746,658
• Publication Number:
  US 20010024661A1
• Time in Patent Office: 1,180 Days
• Field of Search: 604/264, 604/265, 428/35.7, 428/36.9, 606/76, 424/422, 623/1.1, 623/1.42, 623/1.43, 623/1.45
• 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 comprising the anti-infective 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 comprised in either hydrophilic or hydrophobic polymers. It is also based on the discovery that chlorhexidine free base and triclosan, used together, are incorporated into polymeric medical articles more efficiently. Medical articles prepared according to the invention offer the advantage of preventing or inhibiting infection while avoiding undesirably high release of anti-infective agent, for example into the bloodstream of a subject.

Claims

1. A polymeric medical article which has been impregnated with a treatment solution comprising between 1 and 5 percent of chlorhexidine, wherein the chlorhexidine consists essentially of a mixture of chlorhexidine free base and a chlorhexidine salt.

2. A method of preparing an infection resistant medical article comprising:

(i) placing the medical article in an impregnating solution comprising

(a) a solvent selected from the group consisting of water, reagent alcohol, tetrahydrofuran, and mixtures thereof, and

(b) a mixture of chlorhexidine free base and chlorhexidine salt in a weight/weight ratio of about 1;

1, wherein the total weight of chlorhexidine is between 1 and 10 percent of the weight of the impregnating solution;

(ii) soaking the medical article in the impregnating solution for a period of time sufficient to allow the medical article to swell and to incorporate the chlorhexidine;

(iii) removing the medical article from the impregnating solution; and

(iv) drying the medical article.

3. The method of claim 2, wherein the total weight percent of chlorhexidine in step (1) (b) is about 2-10.

4. A method of preparing an infection resistant medical article comprising:

(i) placing the medical article in an impregnating solution comprising

(a) a solvent selected from the group consisting of water, reagent alcohol, tetrahydrofuran, and mixtures thereof, and

(b) a mixture of chlorhexidine free base and chlorhexidine salt, wherein the total weight of chlorhexidine is between 1 and 10 percent of the weight of the impregnating solution;

(ii) soaking the medical article in the impregnating solution for a period of time sufficient to allow the medical article to swell and to incorporate the chlorhexidine;

(iii) removing the medical article from the impregnating solution; and

(iv) drying the medical article.