Antimicrobial Medical Devices Containing Chlorhexidine Free Base And Salt

• US 20080075761A1
• Filed: 11/28/2007
• Published: 03/27/2008
• Est. Priority Date: 12/22/2000
• Status: Active Grant

• Current Assignee: Lester Sampath, Shanta Modak
• Original Assignee: Lester Sampath, Shanta Modak
• Inventors: Modak, Shanta, Sampath, Lester
• Granted Patent: US 8,383,143 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61L 15/44 Medicaments
• 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 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C09D 175/04 Polyurethanes

Abstract

The present disclosure invention relates to medical devices treated with a solution comprising one or more solvents and a combination of chlorhexidine free base and a water-soluble chlorhexidine salt in a weight/weight ratio of between about 1:1 to about 1:5, preferably about 1:1.

Claims

1. An antimicrobial medical article prepared by treating a polymeric medical article, for an effective period of time, with a solution consisting essentially of one or more solvents and a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt, wherein the weight/weight ratio of chlorhexidine free base and the water-soluble chlorhexidine salt in the solution is between 1:

1 to 1;

5.

2. The antimicrobial medical article of claim 1, wherein the ratio is 1:

1.

3. The antimicrobial medical article of claim 1, wherein the solvent is selected from the group consisting of water, alcohol, tetrahydrofuran, dimethylsulfoxide, dimethylformamide, N-methyl-2-pyrrolidone, and mixtures thereof.

4. The antimicrobial medical article of claim 3, wherein the solvent is a mixture of between 10 and 30 percent (volume/volume) tetrahydrofuran and 70 and 90 percent (volume/volume) ethanol.

5. The antimicrobial medical article of claim 7, wherein the solvent is a mixture of 20 percent (volume/volume) tetrahydrofuran and 80 percent (volume/volume) ethanol.

6. The antimicrobial medical article of claim 3, wherein the solvent is a mixture of between 75 and 95 percent (volume/volume) tetrahydrofuran and 5 and 25 percent (volume/volume) methanol.

7. The antimicrobial medical article of claim 6, wherein the solvent is a mixture of about 85 percent (volume/volume) tetrahydrofuran and 15 percent (volume/volume) methanol.

8. The antimicrobial medical article of claim 1, wherein the article is a hydrophilic polymeric medical article.

14. The antimicrobial medical article of claim 1, wherein the article is a hydrophobic polymeric medical article.

15. The antimicrobial medical article of claim 14, wherein the article is expanded polytetrafluoroethylene.

16. The antimicrobial medical article of claim 14, wherein the article is a polytetrafluoroethylene soft tissue patch.

9-13. -13. (canceled)

17. An antimicrobial medical article prepared by treating a polymeric medical article, for an effective period of time, with a solution consisting essentially of

(1) one or more solvents;

(2) a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt; and

(3) one or more of (i) an organic acid, at a concentration of between 0.1 and 5 percent;

(ii) an anti-inflammatory agent, at a concentration of between 0.1 and 5 percent;

or (iii) a hydrogel at a concentration of between 0.5 to 10 percent,

wherein the weight/weight ratio of chlorhexidine free base and the water-soluble chlorhexidine salt in the solution is between 1;

1 to 1;

5.

18. The antimicrobial medical article of claim 17, wherein the concentration of organic acid in the solution is between 0.1 and 2 percent.

19. The antimicrobial medical article of claim 17, wherein the concentration of anti-inflammatory agent is between 0.1 and 1 percent.

20. The antimicrobial medical article of claim 17, wherein the concentration of hydrogel in the solution is between 1 and 5 percent.

21. A method of preparing a medical article comprising the steps of:

(i) placing the medical article in a solution consisting essentially of (a) a solvent selected from the group consisting of water, reagent alcohol, tetrahydrofuran, dimethylsulfoxide, dimethylformamide, N-methyl-2-pyrrolidone, and mixtures thereof; and

(b) a mixture of chlorhexidine free base and a water-soluble chlorhexidine salt, wherein the weight/weight ratio of chlorhexidine free base and water-soluble chlorhexidine salt in the solution is between 1;

1 to 1;

5;

(ii) soaking the medical article in the solution for an effective period of time to allow the medical article to swell;

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

(iv) drying the medical article.

22. (canceled)