Enhanced fatigue strength orthopaedic implant with porous coating and method of making same

Abstract

A method for producing an orthopaedic implant having enhanced fatigue strength. A forged implant substrate having an elongated stem is incorporated with a melting point lowering substance. Then, metal particles are sintered to the substrate, forming a porous layer on the substrate which enhances bone ingrowth or the mechanical interlock with bone cement. Advantageously, the sintering occurs at a lower temperature than if the substance were not incorporated into the substrate, which in turn results in an enhanced fatigue strength of the inventive implant. The fatigue strength of a forged or cast implant can also be improved by nitrogen diffusion hardening and/or thermally processing the implant after the porous coating is adhered by sintering. Further, the fatigue strength can be further improved by combining incorporating the melting point lowering substance with nitrogen diffusion hardening and/or aging treatment subsequent to sintering.

What is claimed is:  
     
         1 . A method for forming a porous layer on a forged orthopaedic implant, said method comprising the steps of: 
 (a) providing an orthopaedic implant substrate formed from a forged metal alloy and having a surface adapted to support a porous layer and providing a plurality of metallic particles;    (b) incorporating a substance into the forged substrate which reduces the melting point of the substrate;    (c) bringing the substrate surface and the metallic particles into contact with one another; and    (d) heating the metallic particles and the substrate to a temperature less than the reduced melting point, whereby the particles sinter and bond to the surface.    
     
     
         2 . The method of  claim 1 , further comprising incorporating the substance into the plurality of metallic particles.  
     
     
         3 . The method of  claim 1 , further comprising the following steps: 
 gas quenching the implant to at least room temperature after sintering;    heating the implant to an aging temperature range of about 800° F. to 2100° F.; and    aging the implant having the metallic particles bonded thereto within the aging temperature range for 1 to 100 hours.    
     
     
         4 . The method of  claim 3 , wherein the gas quenching step comprises cooling the implant to below −90° F.  
     
     
         5 . The method of  claim 4 , wherein the gas quenching step comprises cooling the implant to between −90° F. and −300° F.  
     
     
         6 . The method of  claim 1 , wherein the incorporation step comprises nitrogen diffusion hardening.  
     
     
         7 . The method of  claim 1 , wherein the incorporation step comprises ion implantation.  
     
     
         8 . The method of  claim 1 , wherein the incorporation step comprises solid state thermal diffusion.  
     
     
         9 . The method of  claim 1 , wherein the incorporation step comprises blasting.  
     
     
         10 . The method of  claim 1 , wherein the incorporation step comprises a thermal coating process.  
     
     
         1 . The method of  claim 1 , wherein the incorporation step is done in at least one of a carbon and nitrogen atmosphere.  
     
     
         12 . The method of  claim 1 , further comprising slow furnace cooling the substrate subsequent to sintering.  
     
     
         13 . The method of  claim 1 , further comprising nitrogen diffusion hardening of the implant subsequent to step (d), wherein the nitrogen diffusion hardening comprises exposing the implant to a nitrogen atmosphere at a process temperature within the range of 500° F. and 2400° F. for at least one-half hour.  
     
     
         14 . The method of  claim 13  further comprising subsequent to step (d) the steps of: 
 gas quenching the implant to at least room temperature after sintering;  
 heating the implant to an aging temperature range of about 800° F. to 2100° F.; and  
 aging the implant having the metallic particles bonded thereto within the aging temperature range for 1 to 100 hours.  
 
     
     
         15 . The method of  claim 13  further comprising subsequent to step (d) slowly cooling the implant to room temperature over a period of time greater than 0.5 hours.  
     
     
         16 . The method of  claim 1  wherein step (b) is done by nitrogen diffusion hardening the substrate and further comprising the step of a nitrogen diffusion hardening the implant subsequent to step (d).  
     
     
         17 . The method of  claim 1 , wherein the implant provided in step (a) is made of a cobalt-chromium-molybdenum alloy.  
     
     
         18 . The method of  claim 1 , wherein the substance incorporated in step (b) is selected from the group consisting essentially of carbon, silicon, nitrogen, niobium, columbium, tantalum, chromium carbides, chromium nitrides, chromium silicides, molybdenum silicides, chromium borides, silicon carbides, silicon nitrides, titanium carbides, titanium aluminides, titanium silicides, zirconium carbides and zirconium silicides.  
     
     
         19 . A method for increasing fatigue strength of an implant having a porous layer thereon, said method comprising the steps of: 
 (a) providing an implant substrate formed from a metal alloy and having a surface adapted to support a porous layer and providing a plurality of metallic particles;    (b) bringing the substrate surface and the metallic particles into contact with one another;    (c) heating the metallic particles and the implant substrate to a temperature sufficient to sinter the particles to the surface, whereby the particles bond to the surface and form a porous layer;    (d) then gas quenching the implant with particles bonded thereto down to at least room temperature;    (e) then heating the substrate to an aging temperature range of about 800° F. to 2100° F.; and    (f) aging the implant having the metallic particles bonded thereto within the aging temperature range for 1 to 100 hours.    
     
     
         20 . The method of  claim 19 , wherein the gas quenching step comprises cooling the implant to below −90° F.  
     
     
         21 . The method of  claim 20 , wherein the gas quenching step comprises cooling the implant to between −90° F. and −300° F.  
     
     
         22 . A method for increasing fatigue strength of an implant having a porous layer thereon, said method comprising the steps of: 
 (a) providing an implant substrate formed from a metal alloy and having a surface adapted to support a porous layer and providing a plurality of metallic particles;    (b) bringing the substrate surface and the metallic particles into contact with one another;    (c) heating the metallic particles and the implant substrate to a temperature sufficient to sinter the particles to the surface, whereby the particles bond to the surface and form a porous layer;    (d) slowly cooling the implant to room temperature over a period of time greater than 0.5 hours.    
     
     
         23 . A method of increasing the fatigue strength of a forged implant, comprising: 
 (a) providing a forged orthopaedic implant substrate; and    (b) exposing the substrate to a nitrogen enriched atmosphere at a process temperature within the range of 500° F. to 2400° F. for a process time duration sufficient to achieve increased fatigue strength.    
     
     
         24 . The method of  claim 23 , wherein the substrate provided in step (a) comprises forged cobalt-chromium-molybdenum alloy.  
     
     
         25 . The method of  claim 23 , further comprising sintering a porous layer to the implant substrate prior to step (a).  
     
     
         26 . The method of  claim 25  further comprising the following steps subsequent to Step (b): 
 gas quenching the implant to at least room temperature;  
 heating the implant to an aging temperature range of about 800° F. to 2100° F.; and  
 aging the implant having the metallic particles bonded thereto within the aging temperature range for 1 to 100 hours.  
 
     
     
         27 . An orthopaedic implant made in accordance with the method of  claim 1 .  
     
     
         28 . An orthopaedic implant made in accordance with the method of  claim 19 .  
     
     
         29 . An orthopaedic implant made in accordance with the method of  claim 23 .  
     
     
         30 . An orthopaedic implant comprising a body having an outer surface, the outer surface including a melting point lowering additive incorporated into it, and particles diffusion bonded to the outer surface.  
     
     
         31 . An orthopaedic implant comprising a body having an outer surface and particles sintered to the outer surface, the implant having nitrogen diffused into it.  
     
     
         32 . An orthopaedic implant comprising a body with an outer surface, the body comprising cobalt-chromium-molybdenum alloy, and particles comprising cobalt-chromium-molybdenum alloy sintered onto the outer surface, the fatigue strength of the implant being greater than or equal to 60 ksi.  
     
     
         33 . The implant of  claim 32  wherein the outer surface includes a melting point lowering additive incorporated into it.  
     
     
         34 . The implant of  claim 33  further wherein the implant comprising the body and bonded particles has nitrogen diffused into it.  
     
     
         35 . The implant of  claim 34  further wherein the implant is gas quenched to room temperature or lower and aged at a temperature ranging from 800° F. to 2100° F.  
     
     
         36 . The implant of  claim 32  wherein the implant comprising the body and bonded particles has nitrogen diffused into it.  
     
     
         37 . The implant of  claim 32  wherein the implant is gas quenched to room temperature or lower and aged at a temperature ranging from 800° F. to 2100° F.