Antimicrobial medical articles containing a synergistic combination of anti-infective compounds and octoxyglycerin

• US 20040208908A1
• Filed: 04/16/2003
• Published: 10/21/2004
• Est. Priority Date: 04/16/2003
• Status: Abandoned Application

• 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., Gaonkar, Trupti
• Application Number:
  US10/414,902
• Publication Number:
  US 20040208908A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 33/38 Silver; Compounds thereof
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/46 Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
• CPC Class Codes: A61L 17/005 containing a biologically active substance, e.g. a medicament or a biocide
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• 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 27/54 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

Abstract

Medical articles impregnated with antimicrobial compositions containing synergistic combinations of octoxyglycerin and other anti-infective compounds are disclosed. Such medical articles may include urinary catheters, central venous catheters, tracheal catheters, arterial grafts, wound dressings, sutures, or any other medical articles derived from polymeric substrates such as biomedical polyurethane, biomedical polyvinylchloride (PVC), biomedical silicon, biodegradable polymers, polytetrafluoroethylene (PTFE), etc. or from natural products including natural rubber, silk or cotton fiber.

Claims

1. A polymeric medical article treated with a treatment solution comprising between between about 1.0 percent and about 20.0 percent of an anti-infective compound, and between about 1.0 percent and about 10.0 percent of octoxyglycerin.

2. The polymeric medical article of claim 1, wherein the anti-infective compound is selected from a group consisting of chlorhexidine free base, a chlorhexidine salt, triclosan, an antibiotic, a silver compound, a trivalent bismuth salt, and mixtures thereof.

23. The polymeric medical article of claim 1, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

24. The polymeric medical article of claim 23, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

3. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, and between about 1.0 percent and about 10.0 percent of octoxyglycerin.

25. The polymeric medical article of claim 3, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

26. The polymeric medical article of claim 25, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

4. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, between about 1.0 percent and about 10.0 percent of octoxyglycerin, and between about 0.1 percent and about 2.0 percent of a silver compound.

5. The polymeric medical article of claim 4, wherein the silver compound is selected from the group consisting of silver carbonate and silver sulfadiazine.

27. The polymeric medical article of claim 4, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

28. The polymeric medical article of claim 27, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

6. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, between about 1.0 percent and about 10.0 percent of octoxyglycerin, and between about 0.5 percent and about 2.0 percent of minocycline.

29. The polymeric medical article of claim 6, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

30. The polymeric medical article of claim 29, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

7. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, between about 1.0 percent and about 10.0 percent of octoxyglycerin, between about 0.5 percent and about 2.0 percent of minocycline, and between about 0.1 percent and about 2.0 percent of a silver compound.

8. The polymeric medical article of claim 7, wherein the silver compound is selected from the group consisting of silver carbonate and silver sulfadiazine.

31. The polymeric medical article of claim 7, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

32. The polymeric medical article of claim 31, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

9. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, between about 1.0 percent and about 10.0 percent of octoxyglycerin, and between about 0.5 percent and about 2.0 percent of a trivalent bismuth salt.

10. The polymeric medical article of claim 9, wherein the trivalent bismuth salt is bismuth nitrate.

33. The polymeric medical article of claim 9, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

34. The polymeric medical article of claim 33, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

11. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, between about 1.0 percent and about 10.0 percent of octoxyglycerin, between about 0.5 percent and about 2.0 percent of a trivalent bismuth salt, and between about 0.1 percent and about 2.0 percent of a silver compound.

12. The polymeric medical article of claim 11, wherein the trivalent bismuth salt is bismuth nitrate.

13. The polymeric medical article of claim 11, wherein the silver compound is selected from the group consisting of silver carbonate and silver sulfadiazine.

35. The polymeric medical article of claim 11, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

36. The polymeric medical article of claim 35, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

14. A polymeric medical article treated with a treatment solution comprising between about 0.5 percent and about 5 percent of chlorhexidine, between about 0.05 percent and about 2.0 percent of triclosan, between about 1.0 percent and about 10.0 percent of octoxyglycerin, between about 0.5 percent and about 2.0 percent of minocycline, and between about 0.5 percent and about 2.0 percent of a trivalent bismuth salt.

15. The polymeric medical article of claim 14, wherein the trivalent bismuth salt is bismuth nitrate.

37. The polymeric medical article of claim 14, wherein the medical article is selected from the group consisting of a catheter, the port of a catheter, the hub of a catheter, an arterial graft, a wound dressing, a suture, a wound drainage tube, a soft tissue patch, a glove, a shunt, a stent, a guide wire, a prosthetic device.

38. The polymeric medical article of claim 37, wherein the catheter is selected from the group consisting of a urinary catheter, a vascular catheter, a single lumen central venous catheter, a multiple lumen central venous catheter, a peripherally inserted central venous catheter, an endotracheal catheter, an emergency infusion catheter, a percutaneous sheath introducer system, and a thermodilution catheter.

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

(a) placing the medical article in a treatment solution comprising a solvent selected from the group consisting of water, ethanol, methanol, tetrahydrofuran, and mixtures thereof, wherein the solvent contains between about 0 percent and about 10 percent of a medical polyurethane and about 1.0 percent and about 20 percent of an anti-infective compound and octoxyglycerin for a period of time sufficient to allow the medical article to become coated with the anti-infective compound;

(b) removing the medical article from the treatment solution; and

(c) drying the medical article.

17. The method of claim 16, wherein the anti-infective compound is selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, triclosan, an antibiotic, a silver compound, a trivalent bismuth salt, and mixtures thereof.

18. The method of claim 16, wherein octoxyglycerin is present in the treatment solution at a concentration between about 3 percent and about 7 percent.

19. The method of claim 16, wherein the medical article is dipped in the treatment solution for a period of time sufficient to allow the medical article to incorporate the anti-infective compound.

20. The method of claim 16 further comprising:

(a) placing the dried medical article of element (c) in a coating solution comprising a solvent selected from the group consisting of water, ethanol, methanol, tetrahydrofuran, and mixtures thereof, wherein the solvent contains between about 1.0 percent and about 10 percent of a medical polyurethane, between about 0 percent and about 20 percent of an anti-infective compound, and octoxyglycerin;

(b) removing the medical article from the coating solution; and

(c) drying the medical article.

21. The method of claim 20, wherein the anti-infective compound is selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, triclosan, an antibiotic, a silver compound, a trivalent bismuth salt, and mixtures thereof.

22. The method of claim 20, wherein octoxyglycerin is present in the coating solution at a concentration between about 0 percent and about 7 percent.

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

(a) placing the medical article in a treatment solution comprising a solvent selected from the group consisting of water, reagent alcohol, tetrahydrofuran, and mixtures thereof, wherein the solvent contains between about 0 percent and about 10 percent of a medical polyurethane and about 1.0 percent and about 20 percent of an anti-infective compound for a period of time sufficient to allow the medical article to become coated with the anti-infective compound;

(b) removing the medical article from the treatment solution; and

(c) drying the medical article;

(d) placing the dried medical article in a coating solution comprising a solvent selected from the group consisting of water, ethanol, methanol, tetrahydrofuran, and mixtures thereof, wherein the solvent contains between about 1.0 percent and about 10 percent of a medical polyurethane, between about 0 percent and about 20 percent of an anti-infective compound, and octoxyglycerin;

(e) removing the medical article from the coating solution; and

(f) drying the medical article.

40. The method of claim 39, wherein the anti-infective compound is selected from the group consisting of chlorhexidine free base, a chlorhexidine salt, triclosan, an antibiotic, a silver compound, a trivalent bismuth salt, and mixtures thereof.

41. The method of claim 40, wherein octoxyglycerin is present in the coating solution at a concentration between about 0 percent and about 7 percent.