Antimicrobial compositions

• US 4,603,152 A
• Filed: 10/01/1984
• Issued: 07/29/1986
• Est. Priority Date: 11/05/1982
• Status: Expired due to Term

• Current Assignee: Allegiance Corporation (Cardinal Health, Inc.)
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Laurin, Dean, Stupar, James
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Moore, M. L.
• Application Number:
  US06/655,762
• Time in Patent Office: 666 Days
• Field of Search: 106/15.05, 106/16, 523/122, 604/265
• US Class Current: 604/265
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 25/10 Macromolecular compounds
• CPC Class Codes: A01N 59/16 Heavy metals; Compounds thereof
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• 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 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: C08K 3/015 Biocides macromolecular substances as carriers for biocide material A01N25/10
• CPC Class Codes: C08K 3/105 Compounds containing metals of Groups 1 to 3 or of Groups 11 to 13 of the Periodic Table
• CPC Class Codes: C08K 3/22 of metals
• CPC Class Codes: C08L 55/02 ABS [Acrylonitrile-Butadiene-Styrene] polymers

Abstract

Antimicrobial compositions finding particular utility for coating access systems, lead devices including shunts, cannulae, catheters, catheter adapters, wires and other solid or hollow tubular devices used for a variety of medical purposes is provided. The composition comprises a material selected from the group consisting of acrylonitrile-butadiene-styrene copolymers, polyvinyl chloride, mixtures thereof, polyesters, polyurethanes, styrene-block copolymers, natural and synthetic rubbers, polycarbonates, nylon and silicone rubber mixed with an oligodynamic material consisting essentially of compounds of physiological, antimicrobial metals.

Claims

1. An antimicrobial composition comprising:

30 to 85 percent by weight of a binder consisting essentially of a material selected from the group consisting of acrylonitrile-butadiene-styrene copolymers, polyvinyl chloride, mixtures thereof, polyesters polyurethanes, styrene-block copolymers, natural and synthetic rubbers, polycarbonates, nylon and silicone rubber; and

15 to 70 percent by weight of an antimicrobial agent selected from the group consisting of compounds of antimicrobial metals and mixtures thereof that are physiologically compatible with human tissue, said binder having a sufficiently low dielectric constant so as to allow said antimicrobial agent to form a chain-like structure to create an initial dose of antimicrobial action upon first use by allowing antimicrobial ions on a surface of said composition to dissolve, said chain-like structure providing a pathway in said binder to allow interior antimicrobial ions in said composition to come to said surface of said composition to provide subsequent doses of antimicrobial action.

2. The antimicrobial composition of claim 1 in which said mixtures of acrylonitrile-butadiene-styrene copolymers and polyvinyl chloride consist of 25 to 75 percent by weight of acrylonitrile-butadiene-styrene copolymers and 25 to 75 percent by weight of polyvinyl chloride.

3. The antimicrobial composition of claim 1 in which said antimicrobial agent is selected from the group consisting of oxides and salts of silver and gold.

4. The antimicrobial composition of claim 1 in which said antimicrobial agent is selected from the group consisting of silver compounds.

5. The antimicrobial composition of claim 4 in which said antimicrobial agent is silver oxide.

6. The antimicrobial composition of claim 5 wherein said zone of inhibition forms, in 24 hours, a solution of at least 10^-6 molar concentration of silver ion concentration in a stagnant film of urine in contact with said surface.

7. An antimicrobial composition for coating articles comprising:

30 to 85 percent by weight of a binder;

15 to 70 percent by weight of an antimicrobial agent selected from the group consisting essentially of silver compounds, silver oxides and mixtures thereof, said binder having a sufficiently low dielectric constant so as to allow said antimicrobial agent to form a chain-like structure to create an initial dose of antimicrobial action upon first use by allowing antimicrobial ions on a surface of said composition to dissolve, said chain-like structure providing a pathway in said binder to allow interior antimicrobial ions in said composition to come to said surface of said composition to provide subsequent doses of antimicrobial action.

8. The antimicrobial composition for coating articles of claim 7 wherein said binder consists essentially of acrylonitrile-butadiene-styrene copolymers.

9. The antimicrobial composition for coating articles of claim 7 wherein said binder consists essentially of a mixture of 35 to 65 percent by weight of acrylonitrile-butadiene-styrene copolymers and 35 to 65 percent by weight of polyvinyl chloride.

10. The antimicrobial composition for coating articles of claim 9 wherein said zone of inhibition forms, in 24 hours, a solution of at least 10^-6 molar concentration of silver ion concentration in a stagnant film of urine in contact with said surface.

16. The silicone rubber foley catheter of claim 7 wherein said antimicrobial metal compound is of small particle size completely dissolved throughout the binder to provide and maintain a desired zone of inhibition in a stagnant film of urine in contact with said catheter for the longest possible period of time.

17. The silicone rubber foley catheter of claim 16 wherein said binder is 95% by weight alkoxy curing RTV rubber and said antimicrobial metal is 5% by weight silver sulfadiazine.

18. The silicone rubber foley catheter of claim 17 wherein said binder is 95-99% by weight alkoxy curing RTV rubber and said antimicrobial metal is 1-5% by weight of silver oxide, forming a smooth, adherent, strong antimicrobial coating capable of being stretched fifty (50) percent and further providing safe effective and long lasting zones of inhibition.

11. A catheter adapter for use in indwelling urethral catheterization including an antimicrobial coating thereon;

said antimicrobial coating comprising a binder and an antimicrobial metal compound;

said binder being from 30-99.85% by weight of the coating and selected from a group consisting essentially of acrylonitrile-butadiene-styrene copolymers, polyvinyl chloride, polyesters, polyurethanes of mixtures thereof;

said antimicrobial metal compound being 0.15-70% by weight o the coating selected from the group consisting of compounds of antimicrobial metals and mixtures thereof that are physiologically compatible with human tissue, said binder having a sufficiently low dielectric constant so as to allow said antimicrobial agent to form a chain-like structure to create an initial dose of antimicrobial action upon first use by allowing antimicrobial ions on a surface of said composition to dissolve, said chain-like structure providing a pathway in said binder to allow interior antimicrobial ions in said composition to come to said surface of said composition to provide subsequent doses of antimicrobial action.

12. The catheter adapter of claim 11 wherein said binder is of a high dielectric constant to provide discreetly dissolved particles on the surface to provide an initial high dose of antimicrobial metal compound.

13. The catheter adapter of claim 12 wherein said antimicrobial metal compound is of large particle size and is discreetly dissolved in the surface of the binder;

and, said antimicrobial composition is selected from the group consisting of oxides and salts of silver and gold.

14. The catheter adapter of claim 13 wherein said antimicrobial composition forms a zone of inhibition which prevents and kills bacteria growth thereabout.

15. A silicone rubber foley catheter for use in indwelling urethral catherterization including an antimicrobial coating thereon;

said antimicrobial coating thereon;

said antimicrobial coating comprising a binder and an antimicrobial metal compound;

said binder being from 30-99.85% by weight of the coating and selected from a group consisting essentially of alkoxy curing RTV rubber, acidtoxy cured RTV silicone rubber, rubber latexes, and mistures thereof;

said antimicrobial metal compound being 0.15-70 by weight of the coating selected from the group consisting of compounds of antimicrobial metals and mixtures thereof that are physiologically compatible with human tissue, said binder having a sufficiently low dielectric constant so as to allow said antimicrobial agent to form a chain-like structure to create an initial dose of antimicrobial action upon first use by allowing antimicrobial ions on a surface of said composition to dissolve, said chain-like structure providing a pathway in said binder to allow interior antimicrobial ions in said composition to come to said surface of said composition to provide subsequent doses of antimicrobial action.

19. A flexible polyvinyl chloride catheter for use in short term indwelling urethral catherterization including an antimicrobial coating thereon;

said antimicrobial coating comprising a binder and an antimicrobial metal compound;

said binder being from 30-99.85% by weight of the coating and being of a high dielectric constant; and

said antimicrobial metal compound being 0.15-70% by weight of the coating and being of small particle size and selected from the group consisting of compounds of antimicrobial metals and mistures thereof that are physiologically compatible with human tissue, said binder having a sufficiently low dielectric constant so as to allow said antimicrobial agent to form a chain-like structure to create an initial dose of antimicrobial action upon first use by allowing antimicrobial ions on a surface of said composition to dissolve, said chain-like structure providing a pathway in said binder to allow interior antimicrobial ions in said composition to come to said surface of said composition to provide subsequent doses of antimicrobial action.