Method of producing a biocompatible prosthesis

• US 5,849,206 A
• Filed: 02/04/1997
• Issued: 12/15/1998
• Est. Priority Date: 08/15/1994
• Status: Expired due to Term

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Original Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Inventors: Amon, Michael, Bolz, Armin
• Primary Examiner(s): Breneman, R. Bruce
• Assistant Examiner(s): ALANKO, ANITA KAREN
• Application Number:
  US08/794,375
• Time in Patent Office: 679 Days
• Field of Search: 216/37, 216/63, 216/74, 438/1, 438/483, 427/530
• US Class Current: 216/63
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2310/00742 Coating made of silicon carbide
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 33/027 Other specific inorganic materials not covered by A61L33/022 or A61L33/025
• CPC Class Codes: C23C 16/0245 by etching with a plasma
• CPC Class Codes: C23C 16/0272 Deposition of sub-layers, e.g. to promote the adhesion of the main coating
• CPC Class Codes: C23C 16/325 Silicon carbide

Abstract

A method of producing a biocompatible prosthesis based on a substrate made essentially of metal or ceramic. The substrate is placed into a reactor chamber of a cathodic vapor deposition arrangement and the chamber is evacuated to a predetermined pressure. A predetermined, negative bias voltage is then applied to the substrate and the substrate is surface treated by adding an etching gas to the reactor chamber, at a predetermined, first flow rate and coupling in a high frequency power with a first, predetermined power density for ionic etching for a first, predetermined period of time. The surface treated substrate is separated from the negative bias voltage and a semiconductor cover layer is chemical vapor-phase deposited on the substrate by adding to the reactor chamber a multi-component mixture of process gases containing a semiconductor element in bound form at a second, predetermined flow rate and coupling-in of HF power with a predetermined, second power density, for a second, predetermined time period.

Claims

1. A method of producing a biocompatible prosthesis based on a prefabricated substrate comprised essentially of metal or ceramic, said method comprising:

placing the substrate into a reactor chamber of a cathodic vapor deposition arrangement and evacuating the chamber to a pressure;

surface treating the substrate by applying a negative bias voltage to the substrate, and adding an etching gas, at a first flow rate and coupling in a high frequency (HF) power, with a first power density, into the reactor chamber for ionic etching a surface of the substrate for a first period of time;

separating the surface-treated substrate from the negative bias voltage; and

chemical vapor-phase depositing a semiconductor cover layer on the surface of the substrate by adding a multi-component mixture of process gases containing a semiconductor element in bound form at a second flow rate and coupling-in of HF power, with a second power density, into the reactor chamber for a second time period.

2. The method according to claim 1, wherein following the surface treating step, said method further comprises:

depositing a thin bonding agent layer, which includes the semiconductor element, onto the surface treated substrate by steps including;

applying a second negative bias voltage to the surface-treated substrate;

supplying a process gas that contains the semiconductor material in bound form at a third flow rate into the reactor chamber; and

coupling into the reactor chamber an HF power with a third power density for a third period of time.

3. The method according to claim 2, wherein the process gas of said supplying step has a single component.

4. The method according to claim 3, wherein the single component process gas of said supplying step comprises SiH₄.

5. The method according to claim 2, wherein the bonding agent layer essentially comprises silicon (Si).

6. The method according to claim 2, wherein said supplying step includes supplying process gas comprising monosilane in hydrogen (SiH₄ :

H₂).

7. The method according to claim 2, including separating the substrate from the negative bias voltage without interruption of the coupling-in of the HF power in said coupling step to thus maintain plasma in the reactor chamber.

8. The method according to claim 2, wherein said step of depositing a thin bonding agent layer includes depositing the bonding agent layer to a thickness of a few nm.

9. The method according to claim 8, wherein said step of depositing a thin bonding agent layer includes depositing the bonding agent layer to a thickness of a about 3 to 5 nm.

10. The method according to claim 2, including forming the bonding agent layer and the semiconductor cover layer so as to blend at an increasing distance from the surface of the substrate and without a distinctive boundary layer by continuously changing a composition of the process gas over a period of time, with the semiconductor element component being removed.

11. The method according to claim 1, wherein the semiconductor element is silicon (Si), and the semiconductor cover layer includes silicon carbide (SiC).

12. The method as according to claim 1, wherein the semiconductor cover layer comprises an amorphous layer.

13. The method according to claim 1, wherein the multi-component mixture of process gases comprises at least monosilane (SiH₄) and methane (CH₄).

14. The method according to claim 1, wherein the etching gas is a single component etching gas.

15. The method according to claim 1, the etching gas in said step of adding an etching gas comprises an inert gas.

16. The method according to claim 15, wherein the inert gas comprises at least one of argon (Ar), Nitrogen (N) and carbon tetrachloride (CCl₄).

17. The method according to claim 1, wherein the substrate comprises one of high-grade steel, a titanium alloy, a tantalum alloy and platinum/iridium alloy.

18. The method according to claim 1, further comprising keeping the temperature of the prefabricated prosthesis substantially constant during the entire method.

19. The method according to claim 18, wherein the substantially constant temperature is 250°

C.

20. The method according to claim 18, wherein said heating step includes substantially inertia-free substrate heating during a transition to and execution of said chemical vapor-phase depositing step.

21. The method according to claim 1, wherein said chemical vapor-phase depositing step includes depositing the semiconductor cover layer to a few hundred nm.

22. The method according to claim 21, wherein said depositing step includes depositing the semiconductor layer to a thickness of about 400 nm.