Prosthetic device having a biocompatible carbon film thereon and a method of and apparatus for forming such device

• US 5,387,247 A
• Filed: 01/03/1990
• Issued: 02/07/1995
• Est. Priority Date: 10/25/1983
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica SpA (Snia SpA)
• Inventors: Arru, Pietro, Vallana, Franco
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Prebilic, Paul
• Application Number:
  US07/462,849
• Time in Patent Office: 1,861 Days
• Field of Search: 623/1, 623/2, 623/3, 623/11, 623/12, 623/66, 623/900, 427/2, 427/41, 427/38, 427/39, 204/192.11, 204/192.12, 7/391, 7/658
• US Class Current: 623/2.42
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2310/00574 Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
• CPC Class Codes: A61L 29/103 Carbon
• CPC Class Codes: C23C 14/0605 Carbon
• CPC Class Codes: C23C 14/205 by cathodic sputtering
• CPC Class Codes: C23C 14/355 using electrons, e.g. triode sputtering

Abstract

A prosthetic device which includes a biocompatible carbon film firmly adherent to a substrate. The carbon preferably is turbostratic and is preferably very thin, e.g., less than about one micron. The thin carbon biocompatible film is dense and 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 triode cathodic sputtered, essentially continuous, uniform coating of biocompatible turbostratic carbon having a density of at least 2.2 g/cm³ and a thickness of from about 0.2 to about 0.8 microns deposited directly on and firmly adherent to said substrate without degradation of said substrate.

3. A prosthetic device as defined in claim 1 wherein said substrate comprises a non-refractory metal.

4. A prosthetic device as defined in claim 3 wherein said non-refractory metal is selected from the group consisting of cobalt-chromium alloys, titanium and titanium alloys.

5. A prosthetic device as defined in claim 1 wherein said substrate comprises a polymeric material having a softening point of less than about 300°

C.

6. A prosthetic device as defined in claim 5 wherein said polymeric material is selected from the group consisting of polyester resins, polytetrafluoroethylene, silicone, polyacetyl resins, polyurethane and polyethylene.

7. A prosthetic device as defined in claim 1 wherein said device is able to repeatedly flex without separation of the carbon coating therefrom.

2. A prosthetic device comprising a substrate, and a triode cathodic sputtered, essentially continuous uniform thin coating of biocompatible turbostratic carbon having a density of at least 2.2 g/cm³ deposited directly on and firmly adherent to said substrate without degradation of said substrate.

8. A prosthetic device as defined in claim 2 wherein said substrate comprises a non-refractory metal.

9. A prosthetic device as defined in claim 8 wherein said non-refractory metal is selected from the group consisting of cobalt-chromium alloys, titanium and titanium alloys.

10. A prosthetic device as defined in claim 2 wherein said substrate comprises a polymeric material having a softening point of less than about 300°

C.

11. A prosthetic device as defined in claim 10 wherein said polymeric material is selected from the group consisting of polyester resins, polytetrafluoroethylene, silicone, polyacetyl resins, polyurethane and polyethylene.

12. A prosthetic device as defined in claim 2 wherein said device is able to repeatedly flex without separation of the carbon coating therefrom.

13. A prosthetic device selected from the group consisting of a cardiac valve, tubing and suture yarn, comprising a substrate, and a triode cathodic sputtered, essentially continuous uniform thin coating of biocompatible turbostratic carbon having a density of at least 2.2 g/cm³ deposited directly on and firmly adherent to said substrate without degradation of said substrate.