Microbe-resistant medical device, microbe-resistant polymeric coating and methods for producing same

• US 7,820,284 B2
• Filed: 12/03/2002
• Issued: 10/26/2010
• Est. Priority Date: 12/03/2001
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Terry, Richard N.
• Primary Examiner(s): Ahmed; Sheeba
• Application Number:
  US10/497,043
• Publication Number:
  US 20050064176A1
• Time in Patent Office: 2,884 Days
• Field of Search: None
• US Class Current: 428/323
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• 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: Y10T 428/25 Web or sheet containing structurally defined element or component and including a second component containing structurally defined particles
• CPC Class Codes: Y10T 428/31507 Of polycarbonate
• CPC Class Codes: Y10T 428/31551 Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane
• CPC Class Codes: Y10T 428/31678 Of metal
• CPC Class Codes: Y10T 428/31721 Of polyimide
• CPC Class Codes: Y10T 428/31725 Of polyamide
• CPC Class Codes: Y10T 428/31786 Of polyester [e.g., alkyd, etc.]
• CPC Class Codes: Y10T 428/31855 : Of addition polymer from unsaturated monomers

Abstract

Microbe-resistant medical devices and methods of making these medical devices are provided. A base coat is applied to at least a portion of a surface of the device. That base coat includes one or more types of antimicrobial particles that are held in the base coat. A polymeric over coat is applied over at least a portion of the base coat. The over coat may be an organic soluble polymer, a water soluble polymer, a hydrogel or any other polymer capable of being coated onto a medical device. The polymer of the over coat is dissolvable in a solvent that does not dissolve the polymeric base coat during application of the over coat. The over coat remains free of the antimicrobial particles by not dissolving the base coat during the over coating process.

Claims

1. A microbe-resistant medical device comprising:

a substrate;

a polymeric base coat applied to at least a portion of the substrate;

at least one type of antimicrobial particle dispersed throughout the base coat; and

a solid polymeric over coat positioned over at least a portion of the base coat;

wherein the polymeric over coat is dissolvable in a solvent that does not dissolve the polymeric base coat during application of the over coat, and wherein the polymeric over coat is substantially free of the antimicrobial.

2. The microbe-resistant medical device of claim 1, wherein the substrate comprises at least one material chosen from:

latex;

polystyrene;

polyester;

polyvinylchloride;

polyurethane;

ABS polymers;

polyamide;

polyimide;

polycarbonate;

polyacrylate;

polyethylene;

polypropylene;

synthetic rubber;

stainless steel;

ceramics;

aluminum oxide;

glass or silicone.

3. The microbe-resistant medical device of claim 1, wherein the polymeric base coat is chosen from:

polyurethane;

polyurea;

polyurethaneurea;

acrylic copolymers;

combinations thereof;

or block co-polymers derived therefrom.

4. The microbe-resistant medical device of claim 1, wherein the antimicrobial particles comprise silver-based compounds chosen from:

silver acetate;

silver benzoate;

silver chloride;

silver carbonate;

silver iodate;

silver iodide;

silver lactate;

silver laurate;

silver oxide;

silver palmitate;

silver protein;

silver sulfadiazine;

silver chloride/titanium dioxide complex;

silver zeolite;

or other silver salts and complexes.

5. The microbe-resistant medical device of claim 1, wherein the antimicrobial particles have an average particle size of up to about 100 microns.

6. The microbe-resistant medical device of claim 1, wherein the polymeric over coat comprises at least one material chosen from:

polyurethane;

polyurethaneurea;

polyvinylpyrrolidone;

polyethylene oxide;

polyacrylic acid;

hydroxyethylmethacrylate;

carboxymethyl cellulose;

polyvinyl alcohol;

polyacrylamide;

dextran;

polysaccharides;

starches;

guar, xanthan and other gums and thickeners;

collagen or gelatins.

7. The microbe-resistant medical device of claim 1, wherein the polymeric base coat is a polyurethane resin that is not soluble in alcohol and the polymeric over coat is an alcohol soluble polyvinylpyrrolidone.

8. The medical device of claim 1, comprising more than one base coat.

9. The medical device of claim 1, wherein the coating comprises at least a second polymeric over coat in addition to the solid polymeric over coat.

10. The medical device of claim 1, wherein the over coat comprises a hydrogel.

11. A microbe-resistant polymeric coating for a medical device, the coating comprising:

a polymeric base coat having antimicrobial particles dispersed throughout; and

a solid polymeric over coat that is substantially free of the antimicrobial and is positioned over at least a portion of the base coat.

12. The microbe-resistant polymeric coating of claim 11, wherein the polymeric base coat is a polyurethane resin that will not dissolve in a solvent system containing more than 50% denatured ethanol.

13. The microbe-resistant polymeric coating of claim 12, wherein the antimicrobial particles are silver zeolite.

14. The microbe-resistant polymeric coating of claim 13, wherein the silver zeolite is present in the base coat at a concentration of about 40% of the combined dry weight of the polymeric base coat and the antimicrobial particles.

15. The microbe-resistant polymeric coating of claim 14, wherein the over coat is a polyurethane that is capable of dissolving in a solvent system containing 85% denatured ethanol.

16. The coating of claim 11, wherein the coating comprises more than one base coat.

17. The coating of claim 11, wherein the coating comprises at least a second polymeric over coat in addition to the solid polymeric over coat.

18. The coating of claim 11, wherein the over coat comprises a hydrogel.

19. A method of preparing a microbe-resistant medical device comprising:

providing a medical device having a surface;

dissolving a first polymer in a first solvent system to prepare a first polymer composition;

dispersing at least one type of antimicrobial particle in the first polymer composition to form a base coat composition;

applying the base coat composition to at least a portion of the surface to form a base coat;

dissolving a second polymer in a second solvent system to form a second polymer composition; and

applying the second polymer composition on to at least a portion of the base coat such that the base coat is not dissolved during application of the second polymer composition and forms a solid over coat substantially free of the antimicrobial.

20. The method of preparing a microbe-resistant medical device of claim 19, wherein the medical device is chosen from:

cannulae;

catheters;

condoms;

contact lenses;

endotracheal and gastroenteric feeding tubes as well as other tubes;

grafts;

guide wires;

implant devices;

IUDs;

medical gloves;

oxygenator and kidney membranes;

pacemaker leads;

peristaltic pump chambers;

shunts;

stents or sutures.

21. The method of preparing a microbe-resistant medical device of claim 20, wherein the medical device is a urinary catheter.

22. The method of preparing a microbe-resistant medical device of claim 19, wherein the base coat is applied by dip coating.

23. The method of preparing a microbe-resistant medical device of claim 19, wherein the base coat is applied by spray coating.

24. A medical device prepared by the method of claim 19.

25. A medical device prepared by the method of claim 20.

26. A medical device prepared by the method of claim 21.

27. The method of claim 19, further comprising applying a second base coat composition.

28. The method of claim 19, further comprising applying a second over coat composition.

31. The method of claim 19, wherein the over coat comprises a hydrogel.

29. A method of overcoating a microbe-resistant medical device, the method comprising:

providing a microbe-resistant medical device at least partially surrounded by a polymeric base coat having at least one type of antimicrobial particle dispersed throughout the base coat;

dissolving an over coat polymer in a solvent system that does not dissolve the base coat during application of the over coat polymer; and

applying the dissolved over coat polymer to at least a portion of the microbe-resistant medical device to form a solid over coat such that the base coat is not dissolved and the over coat is substantially free of the antimicrobial.

30. The method of claim 29, further comprising applying a second over coat composition.

32. The method of claim 29, further comprising applying a second base coat composition.

33. The method of overcoating a microbe-resistant medical device of claim 29, wherein the solvent system that does not dissolve the base coat comprises at least one solvent chosen from:

acetone;

acetonitrile;

aniline;

benzene;

butanol;

carbondisulfide;

carbontetrachloride;

chloroform;

cyclohexane;

dimethylacetamide;

dimethylsulfoxide;

dimethylformamide;

dioxane;

ethanol;

ethyl acetate;

ethylene glycol;

hexane;

isopropyl alcohol;

methanol;

methylene bromide;

methylene chloride;

methyl ethyl ketone;

nitroethane;

pyridine;

tetrahydrofuran;

tetralin;

toluene;

trichloroethylene;

or water.

34. The method of overcoating a microbe-resistant medical device of claim 32, wherein the over coat is applied by dip coating over the base coat.

35. The method of overcoating a microbe-resistant medical device of claim 32, wherein the over coat is applied by spray coating over the base coat.

36. A medical device prepared by the method of claim 32.

37. A urinary catheter prepared by the method of claim 29.

38. The method of claim 29, wherein the over coat comprises a hydrogel.