Non-oxidizing polymeric medical implant

Abstract

A medical implant made of polymeric material having an increased oxidation resistance is formed by a method including the steps of placing a resin powder in a sealed container. A substantial portion of the oxygen is removed from the sealed contained by either a vacuum, an oxygen absorbent or by flushing with inert gas. The container is then repressurized with a gas such as nitrogen, argon, helium or neon so that long term storage may be possible. On use, the resin in transferred to a forming device which both melts and forms the resin in an oxygen reduced atmosphere to produce a polymeric raw material such as a rod or bar stock. The medical implant is then formed from this raw material annealed and sealed in an airtight package in an oxygen reduced atmosphere. The implant is then radiation sterilized and thereafter annealed in the package for a predetermined time and temperature sufficient to form cross-links between any free radicals in neighboring polymeric chains.

1 . An irradiated ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 and having a FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index which does not increase with oven aging at 80° C. for up to 11 days.  
     
     
         2 . The polyethylene as set forth in  claim 1  wherein the FTIR oxidation index of the polyethylene does not increase with oven aging in air at 80° C. for up to 23 days.  
     
     
         3 . The polyethylene as set forth in  claim 1  wherein the weight percent of the polyethylene having a molecular weight below 100,000 is less than 18.4%.  
     
     
         4 . An ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000, a solubility of less than 80.9% in trichlorobenzene and an oxidation index which does not increase during oven aging in air at 80° C. for up to 11 days.  
     
     
         5 . The polyethylene as set forth in  claim 4  wherein the level of free radicals is 1.0×10 17 /gram or less.  
     
     
         6 . The polyethylene as set forth in  claim 4  wherein the FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index does not increase with oven aging in air at 80° C. for up to 23 days.  
     
     
         7 . The polyethylene as set forth in  claim 4  wherein the weight percent of the polyethylene having a molecular weight below 100,000 is less than 18.4%.  
     
     
         8 . The polyethylene as set forth in  claim 4  wherein the weight percent of the polyethylene having a molecular weight below 100,000 is less than 18.4%  
     
     
         9 . An irradiated ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 and a solubility of less than 80.9% in 1,2,4-trichlorobenzene.  
     
     
         10 . The irradiated ultra-high molecular weight polyethylene as set forth in  claim 9  wherein the level of free radicals in the polyethylene is 1.0×10 17 /gram or less.  
     
     
         11 . The irradiated ultra-high molecular weight polyethylene as set forth in  claim 9  wherein the polyethylene has a FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index which does not increase with oven aging in air at 80° C. for up to 11 days.  
     
     
         12 . The irradiated ultra-high molecular weight polyethylene as set forth in  claim 9  wherein the polyethylene has an FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index which does not increase with oven aging in air at 80° C. for up to 23 days.  
     
     
         13 . An irradiated ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 wherein the level of free radicals is 1.0×10 17 /gram or less and an oxidation index which does not increase during oven aging in air at 80° C. for 11 days.  
     
     
         14 . An ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 irradiated and annealed at temperature greater than 25° C. for a sufficient time to have a solubility of less than 80.9% in trichlorobenzene and a non-increasing FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index during oven aging in air at 80° C. for up to 11 days.  
     
     
         15 . The polyethylene as set forth in  claim 14  wherein the FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index does not increase with oven aging in air at 80° C. for up to 23 days.  
     
     
         16 . An ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 irradiated and annealed at a temperature greater than 25° C. for a sufficient time to have a level of free radicals of 1.0×10 17 /gram or less and an oxidation index which does not increase during oven aging in air at 80° C. for 11 days.  
     
     
         17 . An ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 irradiated and annealed at a temperature greater than 25° C. for a sufficient time to have a non-increasing FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index of 0.01 during oven aging in air at 80° C. for 11 days.  
     
     
         18 . An ultra-high molecular weight polyethylene having a weight average molecular weight greater than 400,000 irradiated and annealed at a temperature greater than 25° C. for a sufficient time to have a non-increasing FTIR (Fourier Transform Infra-red Spectroscopy) oxidation index of 0.01 or less during oven aging in air at 80° C. for 11 days and a solubility of less than 80.9% in trichlorobenzene.  
     
     
         19 . The polyethylene as set forth in  claim 14  wherein the weight percent of the polyethylene having a molecular weight below 100,000 is less than 18.4%.