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

• US 20050064176A1
• Filed: 12/03/2002
• Published: 03/24/2005
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Terry, Richard N.
• Granted Patent: US 7,820,284 B2
• Time in Patent Office: Days
• 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 within in the base coat; and

a 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 particles.

2. The microbe-resistant medical device of claim 1, wherein the substrate is a material selected from the group consisting of:

latex;

polystyrene;

polyester;

polyvinylchloride;

polyurethane;

ABS polymers;

polyamide;

polyimide;

polycarbonate;

polyacrylate;

polyethylene;

polypropylene;

synthetic rubber;

stainless steel;

ceramics;

aluminum oxide;

glass and silicone.

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

polyurethane;

polyurea;

polyurethaneurea;

acrylic copolymers;

combinations thereof; and

block co-polymers derived therefrom.

4. The microbe-resistant medical device of claim 1, wherein the antimicrobial particles are silver-based compounds selected from the group consisting of:

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; and

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 is selected from the group consisting of:

polyurethane;

polyurethaneurea;

polyvinylpyrrolidone;

polyethyene oxide;

polyacrylic acid;

hydroxyethylmethacrylate;

carboxymethyl cellulose;

polyvinyl alcohol;

polyacrylamide;

dextran;

polysaccharides;

starches;

guar, xanthan and other gums and thickeners;

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

a polymeric base coat having dispersed antimicrobial particles; and

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

9. The microbe-resistant polymeric coating of claim 8, wherein the polymeric base coat is a polyurethane resin that will not dissolve in a solvent system containing more than 50% denatured ethanol.

10. The microbe-resistant polymeric coating of claim 9, wherein the antimicrobial particles are silver zeolite.

11. The microbe-resistant polymeric coating of claim 10, 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.

12. The microbe-resistant polymeric coating of claim 11, wherein the over coat is a polyurethane that is capable of dissolving in a solvent system containing 85% denatured ethanol.

13. 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 solution;

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

applying the base coat solution 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 solution; and

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

14. The method of preparing a microbe-resistant medical device of claim 13, wherein the medical device is selected from the group consisting of:

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 and sutures.

15. The method of preparing a microbe-resistant medical device of claim 14, wherein the medical device is a urinary catheter.

16. The method of preparing a microbe-resistant medical device of claim 13, wherein the base coat is applied by dip coating.

17. The method of preparing a microbe-resistant medical device of claim 13, wherein the base coat is applied by spray coating.

18. 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 dispersed antimicrobial particle;

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

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

19. The method of overcoating a microbe-resistant medical device of claim 18, wherein the solvent system that does not dissolve the base coat is selected from the group consisting of:

acetone;

acetonitrile;

aniline;

benzene;

butanol;

carbondisulfide;

carbontetrachloride;

chloroform;

cyclohexane;

dimethylacetarnide;

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 and water.

20. The method of overcoating a microbe-resistant medical device of claim 18, wherein the over coat is applied by dip coating over the base coat.

21. The method of overcoating a microbe-resistant medical device of claim 18, wherein the over coat is applied by spray coating over the base coat.