Anti-microbial coating for medical devices

• US 5,681,575 A
• Filed: 05/07/1993
• Issued: 10/28/1997
• Est. Priority Date: 05/19/1992
• Status: Expired due to Term

• Current Assignee: NUCRYST Pharmaceuticals Corp. (The Westaim Corporation)
• Original Assignee: Westaim Technologies Inc.
• Inventors: Burrell, Robert Edward, Morris, Larry Roy
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US08/057,968
• Time in Patent Office: 1,635 Days
• Field of Search: 424/423
• US Class Current: 424/423
• CPC Class Codes: A01N 59/16 Heavy metals; Compounds thereof
• CPC Class Codes: A61B 2018/00119 with metal oxide nitride
• CPC Class Codes: A61L 17/145 Coating
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• 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: C23C 14/0036 Reactive sputtering
• CPC Class Codes: C23C 14/025 Metallic sublayers
• CPC Class Codes: C23C 14/06 characterised by the coating material C23C14/0021 , C23C14/04 take precedence
• CPC Class Codes: C23C 14/0688 Cermets, e.g. mixtures of metal and one or more of carbides, nitrides, oxides or borides
• CPC Class Codes: C23C 14/086 of zinc, germanium, cadmium, indium, tin, thallium or bismuth
• CPC Class Codes: C23C 14/14 Metallic material, boron or silicon
• CPC Class Codes: C23C 14/16 on metallic substrates or on substrates of boron or silicon
• CPC Class Codes: C23C 14/205 : by cathodic sputtering
• CPC Class Codes: C23C 14/225 : Oblique incidence of vaporised material on substrate
• CPC Class Codes: C23C 14/35 : by application of a magnetic field, e.g. magnetron sputtering C23C14/3457 takes precedence
• CPC Class Codes: C23C 14/588 : by mechanical treatment
• CPC Class Codes: H01H 2300/014 : Application surgical instrument
• CPC Class Codes: Y10S 977/781 : Possessing nonosized surface openings that extend partially into or completely through the host material
• CPC Class Codes: Y10S 977/89 : Deposition of materials, e.g. coating, cvd, or ald
• CPC Class Codes: Y10S 977/891 : Vapor phase deposition
• CPC Class Codes: Y10S 977/904 : for medical, immunological, body treatment, or diagnosis
• CPC Class Codes: Y10S 977/931 : Medical device coating

Abstract

Anti-microbial coatings and method of forming same on medical devices are provided. The coatings are formed by depositing a biocompatible metal by vapor deposition techniques to produce atomic disorder in the coating such that a sustained release of metal ions sufficient to produce an anti-microbial effect is achieved. Preferred deposition conditions to achieve atomic disorder include a lower than normal substrate temperature, and one or more of a higher than normal working gas pressure and a lower than normal angle of incidence of coating flux. Anti-microbial powders formed by mechanical working to produce atomic disorder are also provided. The invention extends to other metal coatings and powders similarly formed so as to provide enhanced solubility.

Claims

1. A medical device intended for use in contact with an alcohol or water based electrolyte having an anti-microbial coating on its surface, comprising:

a medical device formed of a substantially bioinert structural material; and

an anti-microbial coating formed on the surface of the medical device, said coating being formed from one or more anti-microbial metals and having sufficient atomic disorder such that the coating, in contact with an alcohol or water based electrolyte, releases ions, atoms, molecules or clusters of the anti-microbial metal into the alcohol or water based electrolyte at a concentration sufficient to provide a localized anti-microbial effect on a sustainable basis.

2. The medical device as set forth in claim 1, wherein the deposition is performed by a physical vapour deposition technique selected from vacuum evaporation, sputtering, magnetron sputtering or ion plating.

3. The medical device as set forth in claim 2, wherein the metal is selected from the group consisting of Ag, Au, Pt, Pd, Ir, Sn, Cu, Sb, Bi, and Zn or alloys or compounds containing one or more of said metals.

4. The medical device as set forth in claim 2, wherein the metal is Ag, Au or Pd or an alloy or compound containing one or more of these metals.

5. The medical device as claimed in claim 1, wherein the coating is a composite coating formed from the anti-microbial metal in a matrix containing atoms or molecules of a material different from the anti-microbial metal, the atoms or molecules of the different material creating atomic disorder in the matrix.

6. The medical device as set forth in claim 5, wherein the different material is one or more of (a) reacted species of the anti-microbial metal or metal compound;

(b) absorbed or trapped atoms or molecules of oxygen, nitrogen, hydrogen, boron, sulphur and halogen; and

(c) an inert metal.

7. The medical device as set forth in claim 5, wherein the different material is one or more of (a) oxides, nitrides, hydrides, halides, borides, and carbides of an anti-microbial or an inert metal;

and (b) absorbed or trapped atoms or molecules containing oxygen, nitrogen, hydrogen, boron, sulphur and halogen.

8. The medical device as claimed in claim 5, wherein the different material is an oxide, nitride, boride, sulphide, halide, or hydride of an inert metal selected from the group consisting of Ta, Ti, Nb, V, Hf, Zn, Mo, Si, and Al.

9. The medical device as claimed in claim 5, wherein the coating comprises silver oxide, silver metal, and optionally absorbed or trapped atoms or molecules containing oxygen, nitrogen, hydrogen, boron, sulphur, and halogen.

10. The medical device as claimed in claim 5, wherein the coating comprises silver oxide, silver oxide and optionally absorbed or trapped atoms or molecules containing oxygen.

11. The medical device as claimed in claim 1, wherein the anti-microbial metal is silver or an alloy or compound containing silver.

12. The medical device as claimed in claim 1, wherein the coating is formed by vapour deposition under conditions which limit diffusion during deposition and which limit annealing or recrystallization following deposition.

13. The medical device as claimed in claim 12, wherein the coating is formed by physical vapour deposition.

14. The medical device as claimed in claim 13, wherein the material is a coating of one or more anti-microbial metals formed on the medical device by vacuum evaporation, sputtering, magnetron sputtering or ion plating.

15. The medical device as claimed in claim 14, wherein the deposition is performed under conditions such that a ratio of the temperature of the medical device to the melting point of the metal or metal compound being deposited is maintained at less than about 0.5.

16. The medical device as claimed in claim 15, wherein the ratio is maintained at less than about 0.3.

17. The medical device as claimed in claim 15, wherein the deposition is performed such that an angle of incidence of the coating flux on the medical device to be coated is less than about 75°

.

18. The medical device as claimed in claim 15, wherein the deposition is performed by arc evaporation at an ambient or working gas pressure of greater than about 0.01 mT.

19. The medical device as claimed in claim 15, wherein the deposition is performed by gas scattering evaporation at a working gas pressure of greater than about 20 mT.

20. The medical device as claimed in claim 15, wherein the deposition is performed by sputtering at a working gas pressure of greater than about 75 mT.

21. The medical device as claimed in claim 15, wherein the deposition is performed by magnetron sputtering at a working gas pressure of greater than about 10 mT.

22. The medical device as claimed in claim 15, wherein the deposition is performed by ion plating at a working gas pressure of greater than about 200 mT.

23. The medical device as set forth in claim 15, wherein the deposition is performed by magnetron sputtering at a working gas pressure of greater than about 30 mT.

24. A medical device intended for use in contact with an alcohol or water based electrolyte having an anti-microbial coating on its surface, comprising:

a medical device formed of a substantially bioinert structural material; and

an anti-microbial coating formed on the surface of the medical device, said coating being formed from one or more anti-microbial metals and having sufficient atomic disorder such that the coating, in contact with an alcohol or water based electrolyte, releases ions, atoms, molecules or clusters of the anti-microbial metal into the alcohol or water based electrolyte at a concentration sufficient to provide a localized anti-microbial effect on a sustainable basis, the atomic disorder providing irregularities in surface topography and inhomogeneities in structure on a nanometer scale and being caused by high concentrations of one or more of point defects in a crystal lattice, vacancies, and line defects comprising dislocations, interstitial atoms, amorphous regions, grain and sub grain boundaries, relative to a normal ordered, crystalline state for the anti-microbial metal.

25. The medical device as set forth in claim 24, wherein the atomic disorder is created in the coating under conditions which limit diffusion such that sufficient atomic disorder is retained in the coating to provide release of atoms, ions, molecules or clusters of the anti-microbial metal into the alcohol or water based electrolyte at an enhanced rate relative to its normal ordered crystalline state.