Surgical implant having multiple layers of sintered porous coating and method

• US 5,104,410 A
• Filed: 10/22/1990
• Issued: 04/14/1992
• Est. Priority Date: 10/22/1990
• Status: Expired due to Term

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Intermedics Orthopedics, Inc.
• Inventors: Chowdhary, Prataprai R.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): GUALTIERI, GINA
• Application Number:
  US07/600,945
• Time in Patent Office: 540 Days
• Field of Search: 427/2, 427/405, 623/11, 623/16, 623/20, 623/22
• US Class Current: 623/11.11
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings

Abstract

A surgical prosthetic device for implant in a patient and method for making said device, the device comprising a composite structure having a solid metal substrate and a porous coating with multiple sintered layers. The porous coating has an external layer to accept bone ingrowth. An intermediate layer bonds the external porous layer to the substrate. The layers are applied in a process of multiple sintering, whereby each successive layer is individually sintered to the substrate or to the proceeding layer, as applicable. This process provides a porous area having increased strength of attachment between the substrate and the external porous layer. An acid etch solution promotes adhesion between the substrate and the intermediate layer thus increasing the consistency of the process. The initial sintering is held at elevated temperature for less time than the sintering of the external layer. At the end of each sintering step, the prosthesis is quick cooled using an inert gas, preferably helium.

Claims

1. A prosthetic implant comprising the combination of a metallic substrate and a porous metallic layer on at least a portion of said substrate, said porous metallic layer being of different composition from said metallic substrate, the porous layer being joined to said substrate through an intermediate, non- porous layer, said intermediate layer having substantially the same composition as the porous layer.

2. A prosthetic implant according to claim 1 wherein the substrate is comprised of cobaslt chrome alloy and wherein the porous layer and the intermediate layer are comprised of titanium.

3. A method of applying a porous coating to a selected portion of surface of a prosthetic implant substrate comprised of a first metallic substance, the method comprising the successive steps of:

cleaning at leas the selected portion of the surface of the substrate;

applying a slurry containing a powder comprised of a second metallic substance to said selected portion;

drying said slurry to leave at least said powder as a residue on said selected portion;

sintering said powder on said substrate to form an intermediate metallic layer;

applying a mixture comprised of a particulate and a filler material for forming pores, said particulate being comprised substantially of said second metallic substance, and

sintering said mixture on said intermediate layer.

4. The method according to claim 3 wherein the step of sintering said powder further comprises

placing said substrate in a sintering furnace;

evacuating air from said furnace;

elevating temperature in said furnace;

maintaining said temperature for a first predetermined length of time; and

cooling said substrate; and

wherein the step of sintering said mixture further comprises

re-placing said substrate in a sintering furnace;

re-evacuating air from said furnace;

re-elevating temperature in said furnace;

maintaining said temperature for a second predetermined length of time, said second period of time being longer than said first period of time; and

re-cooling said substrate.

5. The method according to claim 4 wherein the step of evacuating air from said furnace comprises creating a vacuum of from 10^-5 to 10^-6 torr, and wherein the step of elevating temperature in said furnace comprises elevating the temperature to about 1100°

C., and wherein said first length of time is about one hour.

6. The method according to claim 5 wherein the step of cooling said substrate comprises passing a stream of an inert gas over said substrate.

7. The method according to claim 6 wherein the step of cooling the substrate comprises cooling the substrate at a rate of about 50 to 100°

C./min. to about 35°

C.

8. The method according to claim 3 wherein the step of re-evacuating air from said furnace comprises creating a vacuum of from 10^-5 to 10^-6 torr, and wherein the step of re-elevating the temperature in said furnace comprises elevating the temperature to about 1030°

C., and wherein said second length of time is about two hours.

9. The method according to claim 8 wherein the step of cooling said substrate comprises passing a stream of an inert gas over said substrate.

10. The method according to claim 9 wherein the step of cooling the substrate comprises cooling the substrate at a rate of about 50°

to 100°

C./min. to about 35°

C.

11. The method according to claim 3 wherein the substrate comprises a cobalt-chrome alloy, and wherein the metallic powder and the metallic particulate comprise titanium.

12. The method according to claim 3 wherein the step of cleaning the selected portion of the surface comprises

etching the portion of the surface with acid;

and

grit blasting the portion of the surface.

13. The method according to claim 12 wherein the step of applying said metallic particulate further comprises

grit blasting the portion of the surface;

and

pressing the metallic particulate onto said portion of the surface with a pressure between 30,00 and 40,000 psi.

14. The method according to claim 13 wherein the step of sintering said metallic powder further comprises

placing said substrate in a sintering furnace;

evacuating air from said furnace;

elevating temperature in said furnace;

maintaining said temperature for a first predetermined length of time; and

cooling said substrate; and

wherein the step of sintering said mixture further comprises

re-placing said substrate in a sintering furnace;

re-evacuating air from said furnace;

re-elevating temperature in said furnace;

predetermined length of time, said second period of time being longer than said first period of time; and

re-cooling said substrate.

15. The method according to claim 14 wherein the step of evacuating air from said furnace comprises creating a vacuum of from 10^-5 to 10^-6 torr, and wherein the step of elevating temperature in said furnace comprises elevating the temperature to about 1100°

C., and wherein said first length of time is about one hour.

16. The method according to claim 15 wherein the step of cooling said substrate comprises passing a stream of an inert gas over said substrate.

17. The method according to claim 14 wherein the step of cooling the substrate comprises cooling the substrate at a rate of about 50°

to 100°

C./min. to about 35°

C.

18. The method according to claim 15 wherein the step of re-evacuating air from said furnace comprises creating a vacuum of from 10^-5 to 10^-6 torr, and wherein the step of re-elevating the temperature in said furnace comprises elevating the temperature to about 1030°

C., and wherein said second length of time is about two hours.

19. The method according to claim 16 wherein the step of cooling said substrate comprises passing a stream of an inert gas over said substrate.

20. The method according to claim 19 wherein the step of cooling the substrate comprises cooling the substrate at a rate of about 50°

to 100°

C./min. to about 35°

C.