Prosthesis of polymeric material coated with biocompatible carbon

• US 5,370,684 A
• Filed: 08/18/1992
• Issued: 12/06/1994
• Est. Priority Date: 12/12/1986
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica SpA (Snia SpA)
• Inventors: Santi, Marco, Vallana, Franco, Arru, Pietro
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): PREBILIC, PAUL B
• Application Number:
  US07/931,431
• Time in Patent Office: 840 Days
• Field of Search: 623/1, 623/2, 623/3, 623/11, 623/66, 623/900, 427/2, 427/41, 427/38, 427/39, 204/192.11, 204/192.12
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2310/00574 Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
• CPC Class Codes: A61L 27/303 Carbon
• CPC Class Codes: C23C 14/0605 Carbon
• CPC Class Codes: C23C 14/355 using electrons, e.g. triode sputtering
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A prosthetic device which includes a turbostratic biocompatible carbon film firmly adherent to a substrate and having a density of at least 2.1 g/cm³. The carbon preferably is very thin, e.g. , less than about one micron. The thin carbon biocompatible film covers at least that portion of the substrate which will be in contact with body tissue and/or fluids to insure against physiological rejection and degradation of the prosthetic device. The carbon can be deposited on a variety of substrates, including low temperature substrates, in situ, without adversely affecting the mechanical properties of the substrate. The prosthetic device of the invention is formed by triode sputtering vacuum deposition at a relatively low temperature to achieve the desired results with respect to the deposited carbon and the substrate and with respect to the required adherence therebetween.

Claims

1. A prosthetic device, comprising a substrate, and a thin coating of a turbostratic biocompatible carbon having a density of at least 2.2 g/cm³ firmly adhered to said substrate, said coating deposited on said substrate by triode cathodic sputtering of carbon directly onto said substrate at a low temperature and a low pressure without degradation of said substrate.

2. The prosthetic device of claim 1 whenever said prosthetic device comprises an organic polymer.

3. The prosthetic device of claim 1 wherein said prosthetic device comprises now-refractory metal.

4. The prosthetic device of claim 1, wherein the density of the deposited carbon is between about 2.2 and 2.4 g/cm³.

5. The prosthetic device of claim 2, wherein the substrate is selected from the group consisting of polyester resins, polytetrafluoroethylene, silicone, polyacetal resins, polyurethanes or polyethylene.

6. The prosthetic device of claim 3, wherein said substrate is selected from the group consisting of cobalt-chromium alloys, titanium or titanium alloys.

7. The prosthetic device of claim 1, wherein said biocompatible carbon has a thickness of about 0.1 to 1.0 micron.

8. The prosthetic device of claim 1, wherein the device is tubing, wherein said substrate is an organic polymer, and wherein said biocompatible carbon coating is a dense, uniform film having a thickness of not more than about 1.0 micron.

9. The prosthetic device of claim 1 wherein said device is able to repeatedly flex without separation of the coating therefrom.

10. The prosthetic device of claim 2 wherein said organic polymer has a softening point of less than about 250°

C.

11. A prosthetic device comprising a substrate, and a thin coating of turbostratic biocompatible carbon having a density of at least 2.2 g/cm³ deposited directly on and firmly adherent to said substrate by triode cathodic sputtering of carbon onto said substrate without degradation of said substrate, wherein said substrate is selected from the group consisting of polyester resins, polytetrofluoroethylene, silicone, polyacetyl resins, polyurethanes and polyethylene.

12. The prosthetic device of claim 11 wherein said substrate is selected from the group consisting of cobalt-chromium alloys, titanium or titanium alloys.

13. A prosthetic device selected from the group consisting of a cardiac valve, tubing and suture yarn comprising a substrate and a thin coating of turbostratic biocompatible carbon having a density of at least 2.2 g/cm³ and a thickness of not more than about 1.0 micron deposited directly on and firmly adherent to said substrate by triode cathodic sputtering of carbon onto said substrate without degradation of said substrate.

14. A prosthetic device comprising a substrate and a thin coating of a turbostratic biocompatible carbon having a density of at least 2.2 g/cm³ firmly adhered to said substrate, said coating deposited on said substrate by triode cathodic sputtering of carbon directly onto said substrate at a temperature below the softening point of the substrate without degradation of said substrate.

15. A prosthetic device comprising a substrate and a thin coating of turbostratic biocompatible carbon having a density of at least 2.2 g/cm³ firmly adhered to said substrate, said coating deposit, by triode cathodic sputtering of carbon directly onto said substrate at a temperature below the softening point of said substrate without degration of said substrate, wherein said substrate is selected from the group consisting of polyester resins, polytetrafluoroethylenes, silicones, polyacetyl resins, polyurethanes and polyethylenes.

16. A prosthetic device selected from the group consisting of a cardiac valve, tubing and suture yarn comprising a substrate and a thin coating of turbostratic biocompatible carbon having a density of at least 2.2 g/gm³ and a thickness of not more than about 1.0 micron deposited directly on and firmly adherent to said substrate by triode cathodic sputtering of carbon onto said substrate at a temperature below the softening point of said substrate without degradation of said substrate, wherein said substrate is selected from the group consisting of polyester resins, polytetrafluoroethylenes, silicones, polyacetyl resins, polyurethanes and polyethylenes.

17. A prosthetic device comprising a substrate and a thin coating of a turbostratic biocompatible carbon having a density of 2.4 g/cm³ firmly adhered to said substrate, said coating deposited on said substrate by triode cathodic sputtering of carbon directly onto said substrate at a temperature below the softening point of the substrate without degradation of said substrate.

18. A prosthetic device comprising a substrate, and a thin coating of turbostratic biocompatible carbon having a density of 2.4 g/cm³ firmly adhered to said substrate, said coating deposited by triode cathodic sputtering of carbon directly onto said substrate at a temperature below the softening point of said substrate without degradation of said substrate wherein said substrate is selected from the group consisting of polyester resins, polytetrafluoroethylenes, silicones, polyacetyl resins, polyurethanes and polyethylenes.

19. A prosthetic device selected from the group consisting of a cardiac valve, tubing and suture yarn comprising a substrate and a thin coating of turbostratic biocompatible carbon having a density of 2.4 g/cm³ and a thickness of not more than about 1.0 micron deposited directly on and firmly adherent to said substrate by triode cathodic sputtering of carbon onto said substrate at a temperature below the softening point of said substrate without degradation of said substrate, wherein said substrate is selected from the group consisting of polyester resins, polytetrafluoroethylenes, silicones, polyacetyl resins, polyurethanes and polyethylenes.