Passivation methods for metallic medical implants

• US 5,211,663 A
• Filed: 06/24/1991
• Issued: 05/18/1993
• Est. Priority Date: 06/24/1991
• Status: Expired due to Fees

• Current Assignee: Smith & Nephew Richards Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Richards Incorporated (Smith & Nephew PLC)
• Inventors: Davidson, James A., Kovacs, Paul
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Nguyen, Dinh X.
• Application Number:
  US07/719,805
• Time in Patent Office: 694 Days
• Field of Search: 623/16, 623/11, 623/18, 427/2
• US Class Current: 623/23.6
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: C23C 22/05 using aqueous solutions
• CPC Class Codes: C25D 11/02 Anodisation

Abstract

Passivated implants and passivation methods that provide superior corrosion resistance and surface performance characteristics as compared to conventional nitric acid passivation are disclosed. The method uses either the spontaneous or galvanic passivation of metallic prosthetic implants in aqueous alkali salt solutions containing non-aggressive oxyanions to produce a thin and uniform passive coating on the metal implant, thereby rendering the implant more stable in the biological environment.

Claims

1. A metallic medical implant having a surface covered at least partially with a thin surface film selected from the group consisting of metal oxides and hydroxides wherein the film is produced by the process comprising:

a. immersing the metallic implant in a passivating solution, said solution comprising an aqueous solution of a water soluble metal salt containing an oxyanion in a concentration of from about 0.05 to about 0.25 equivalents per liter; and

b. maintaining the passivating solution containing the implant to a temperature of from about 20°

C. to about 50°

C. for a time sufficient to form a thin, uniform tightly adherent coating of less than about 20 nanometers thickness.

2. The implant according to claim 1 wherein the metallic implant is fabricated from a material selected from the group consisting of titanium, zirconium, hafnium, vanadium, niobium, tantalum and their alloys.

3. The implant according to claim 1 wherein the metal ion of the water soluble metal salt is selected from the group consisting of the alkali metal ions.

4. The implant according to claim 1 wherein the oxyanion is selected from the group consisting of the sulfate, phosphate, monohydrogen phosphate, di-hydrogen phosphate, and borate oxyanions.

5. The metallic implant of claim 1 wherein

a. the step of immersing comprises immersing in an about 0.15 equivalents per liter aqueous solution of sodium sulfate;

and

b. the step of maintaining the passivating solution containing the implant comprises maintaining the passivating slution to a temperature of about 37°

C. for about 24 hours.

6. The implant of claim 1 wherein the metallic implant is fabricated from a material selected from the group consisting of 316L stainless steel, cobalt-chrome-molybdenum steel and Ti--6Al--4V alloy.

7. The implant of claim 1 wherein the metallic implant is fabricated from a metal alloy selected from the stainless steels.

8. A metallic medical implant having a surface covered at least partially with a thin surface film selected from the group consisting of metal oxides and hydroxides wherein the thin film is produced by the process comprising:

a. mechanically coupling the implant to a cathode rod;

b. immersing the metallic implant mechanically coupled to a cathode rod in a passivating solution, the solution comprising an aqueous solution of a water soluble metal salt containing a non-aggressive oxyanion in a concentration of from about 0.05 equivalents per liter to about 0.25 equivalents per liter; and

c. maintaining the passivating solution containing the metallic implant and cathode rod at a temperature of from about 20°

C. to about 50°

C. for a time sufficient to form a passive uniform tightly adherent coating of up to about 20 nanometers thickness on the implant surface.

9. The implant according to claim 8 wherein the metallic implant is fabricated from a material selected from the group consisting of titanium, zirconium, hafnium, vanadium, niobium, tantalum and their alloys.

10. The implant according to claim 8 wherein the water soluble metal is selected from the group consisting of the alkali metals.

11. The implant according to claim 8 wherein the oxyanion is selected from the group consisting of the sulfate, phosphate, monohydrogen phosphate, di-hydrogen phosphate, and borate oxyanions.

12. The metallic implant according to claim 8 wherein

a. the step of immersing comprises immersing the mechanically coupled cathode rod and metallic implant in an about 0.15 equivalents per liter aqueous solution of sodium sulfate;

and

b. the step of maintaining the passivating solution comprises heating to a temperature of about 37°

C. for about 16 hours.

13. The implant of claim 8 wherein the metallic implant is fabricated from a material selected from the group consisting of 316L stainless steel, cobalt-chrome-molybdenum steel and Ti--6Al--4V alloy.

14. The implant of claim 8 wherein the metallic implant is fabricated from a metal alloy selected from the stainless steels.