Medical Implants And Methods Of Manufacture

Abstract

Anti-biofilm osseointegrating and/or tissue-integrating implantable biomaterial devices that optionally can elute therapeutic ions such as magnesium, silver, copper and/or zinc. In certain embodiments, the devices are engineered to produce structures suitable as implants having a relatively high surface population of zeolite. Methods of producing the devices are also disclosed.

What is claimed is: 
     
         1 . A medical implant comprising a thermoplastic polymer defining a main body region and a surface region, said surface region being configured to be exposed to bodily fluid or tissue of a host when said medical implant is implanted in said host, said surface region comprising zeolite in an amount greater than 12% by weight. 
     
     
         2 . The medical implant of  claim 1 , wherein said surface region contains a plurality of indentations containing said zeolite. 
     
     
         3 . The medical implant of  claim 1 , wherein said surface region comprises zeolite in an amount greater than 15% by weight. 
     
     
         4 . The medical implant of  claim 1 , wherein said surface region comprises zeolite in an amount greater than 20% by weight. 
     
     
         5 . The medical implant of  claim 1 , wherein said surface region comprises zeolite in an amount greater than 25% by weight. 
     
     
         6 . The medical implant of  claim 1 , wherein said surface region comprises zeolite in an amount greater than 30% by weight. 
     
     
         7 . The medical implant of  claim 1 , wherein said surface region comprises zeolite in an amount greater than 50% by weight. 
     
     
         8 . The medical implant of  claim 1 , wherein said main body region comprises zeolite in an amount of 12% by weight or less. 
     
     
         9 . The medical implant of  claim 1 , wherein said implant is configured as a member selected from the group consisting of an ACL screw. 
     
     
         10 . The medical implant of  claim 1 , wherein said implant is configured as a spinal implant, a knee implant, a hip stem, a skull flap, a dental implant or a trauma plate. 
     
     
         11 . The medical implant of  claim 1 , wherein said thermoplastic polymer comprises PEEK. 
     
     
         12 . The medical implant of  claim 1 , further comprising carbon fibers. 
     
     
         13 . The medical implant of  claim 1 , wherein said zeolite comprises one or more antimicrobial and/or therapeutic metal ions. 
     
     
         14 . The medical implant of  claim 13 , wherein said one or more metal ions is selected from the group consisting of silver, copper, zinc, magnesium and strontium. 
     
     
         15 . A method of making a medical implant having a main body region and an exposed surface region and comprising a polymer, the method comprising:
 a. heating the polymer to a molten state   b. contacting the polymer with a mixture of zeolite and indentation-forming agent with the application of force to form indentations in said exposed surface region and drive said mixture into the formed indentations of the exposed surface region;   c. cooling the polymer; an   d. washing the resulting composite.   
     
     
         16 . The method of  claim 15 , wherein said polymer is PEEK. 
     
     
         17 . A method of making a medical implant having a main body region and an exposed surface region and comprising a polymer, the method comprising:
 a. heating the polymer to a molten state;   b. contacting the polymer with an indentation-forming member and zeolite to form indentations in said exposed surface region and drive the zeolite into the indentations in the exposed surface region; and   c. cooling the resulting composite structure.   
     
     
         18 . The method of  claim 17 , wherein said polymer is PEEK. 
     
     
         19 . The method of  claim 17 , wherein said indentation-forming member comprises sandpaper. 
     
     
         20 . A method of making a medical implant having a main body region and an exposed surface region and comprising a polymer, the method comprising:
 a. injecting the polymer into the cavity of a mold at elevated temperature sufficient to melt the resin, the mold comprising a surface having a plurality of projections and a coating of zeolite;   b. causing the melted polymer to contact said projections and driving the zeolite into the resin;   c. removing the resulting article from the mold and cooling it.