Bioactive composites of polymer and glass and method for making same

Abstract

The present invention generally relates to bioactive composites of polymer and glass and, more particularly, to bioactive implants. The present invention also relates to methods of manufacturing bioactive composites. The bioactive composite finds utility in a variety of load-bearing clinical applications including spine, orthopaedic and dental procedures.

1 . A bioactive composite comprising a biocompatible polymer and a bioactive glass, wherein the biocompatible polymer has a particle size range from greater than 400 μm to 4,000 μm prior to formation of said bioactive composite. 
     
     
         2 . The bioactive composite of  claim 1 , wherein the biocompatible polymer is an polyaryletherketone polymer. 
     
     
         3 . The bioactive composite of  claim 1 , wherein the biocompatible polymer is polyetheretherketone (PEEK). 
     
     
         4 . The bioactive composite of  claim 1 , wherein the biocompatible polymer is low molecular weight biocompatible polymer. 
     
     
         5 . The bioactive composite of  claim 4 , wherein the low molecular weight biocompatible polymer has a molecular weight from 70,000 to 100,000 M n . 
     
     
         6 . The bioactive composite of  claim 4 , wherein the low molecular weight biocompatible polymer has a melt flow rate from 18 g/10 minutes to 50 g/10 min. 
     
     
         7 . The bioactive composite of  claim 1 , wherein the biocompatible polymer comprises 60-80% by weight of the composite composition. 
     
     
         8 . The bioactive composite of  claim 1 , wherein the bioactive glass is 45S5 or Combeite. 
     
     
         9 . The bioactive composite of  claim 1 , wherein the bioactive glass has a particle size range from 1 μm to 500 μm. 
     
     
         10 . The bioactive composite of  claim 1 , wherein the bioactive glass has a particle size of less than 300 μm. 
     
     
         11 . The bioactive composite of  claim 1 , wherein the bioactive glass has a particle size of less than 150 μm. 
     
     
         12 . The bioactive composite of  claim 1 , wherein the bioactive glass comprises from 5% to 50% by weight of the composite composition. 
     
     
         13 . The bioactive composite of  claim 1 , wherein the bioactive glass comprises from 20% to 40% by weight of the composite composition. 
     
     
         14 . The bioactive composite of  claim 1 , wherein the biocompatible polymer is PEEK and the bioactive glass is Combeite. 
     
     
         15 . The bioactive composite of  claim 1 , wherein the composite further comprises an agent. 
     
     
         16 . The bioactive composite of  claim 15 , wherein the agent is at least one selected from the group consisting of a reinforcing fiber, carbon, a radiopaque material, barium glass, barium sulfate, barium-boroaluminosilicate (BBAS) glass, silica and an e-glass fiber. 
     
     
         17 . The bioactive composite of  claim 15 , wherein the agent is a calcium phosphate, strontium or silver material. 
     
     
         18 . The bioactive composite of  claim 15 , wherein the agent is a radiopacifying agent. 
     
     
         19 . The bioactive composite of  claim 1 , wherein the bioactive composite includes a surface area and wherein the bioactive glass comprises from 3% to 30% of the surface area of the composite. 
     
     
         20 . The bioactive composite of  claim 9 , wherein the bioactive composite has a volume and a surface area and wherein the bioactive glass has edges that form a perimeter for each glass particle, wherein a mean particle to particle distance measured between the edges of the bioactive glass throughout the volume and along the surface area of the bioactive composite is between about 80 μm and 180 μm. 
     
     
         21 . The bioactive composite of  claim 1 , wherein the composite has a compressive strength of at least 110 MPa and a compressive modulus of at least 3.5 GPa. 
     
     
         22 . The bioactive composite of  claim 1 , wherein the biocompatible polymer comprises from 50% to 85% by weight of the composite composition and the bioactive glass comprises from 15% to 50% by weight of the composite composition. 
     
     
         23 . The bioactive composite of  claim 1 , wherein the biocompatible polymer comprises from 65% to 80% by weight of the composite composition and the bioactive glass comprises from 20% to 35% by weight of the composite composition. 
     
     
         24 . The bioactive composite of  claim 1 , wherein the biocompatible polymer comprises from 70% to 80% by weight of the composite composition and the bioactive glass comprises from 20% to 30% by weight of the composite composition. 
     
     
         25 . The bioactive composite of  claim 17 , wherein the biocompatible polymer comprises 50-90% by weight of the composite composition, the bioactive glass comprises 5-50% by weight of the composite composition and the agent comprises 5-50% of the composite composition 
     
     
         26 . A bioactive composite, comprising a PEEK and Combeite, wherein the PEEK has a particle size range from greater than 400 μm to 4,000 μm prior to formation of said bioactive composite, wherein the PEEK has a molecular weight from 70,000 to 100,000 M n , wherein the PEEK comprises from 70% to 80% by weight of the composite composition, wherein the Combeite has a particle size range from 1 μm to 500 μm, and wherein the Combeite comprises from 20% to 30% by weight of the composite composition. 
     
     
         27 . A spinal implant comprising the bioactive composite of  claim 1 . 
     
     
         28 . A spinal implant having an integrated screw hole comprising the bioactive composite of  claim 1 . 
     
     
         29 . A joint implant comprising the bioactive composite of  claim 1 . 
     
     
         30 . A dental implant comprising the bioactive composite of  claim 1 . 
     
     
         31 . A screw comprising the bioactive composite of  claim 1 . 
     
     
         32 . A cannulated screw comprising the bioactive composite of  claim 1 . 
     
     
         33 . A self-tapping screw comprising the bioactive composite of  claim 1 . 
     
     
         34 . A staple comprising the bioactive composite of  claim 1 . 
     
     
         35 . A pellet comprising the bioactive composite of  claim 1 . 
     
     
         36 . A method of preparing a bioactive composite, the method comprising the steps of:
 a) adding in a solid state a biocompatible polymer and a bioactive glass to an extruder to form an extrudable material; and   b) applying energy to the extrudable material to at least the melting temperature of the biocompatible polymer to melt mix the biocompatible polymer and bioactive glass; and   c) extruding a bioactive composite.   
     
     
         37 . The method of  claim 36 , wherein the biocompatible polymer has a particle size of greater than 400 μm to 4,000 μm. 
     
     
         38 . The method of  claim 36 , wherein the biocompatible polymer is an polyaryletherketone polymer. 
     
     
         39 . The method of  claim 36 , wherein the biocompatible polymer is PEEK. 
     
     
         40 . The method of  claim 36 , wherein the biocompatible polymer is low molecular weight biocompatible polymer. 
     
     
         41 . The method of  claim 36 , wherein the low molecular weight biocompatible polymer has a molecular weight from 70,000 to 100,000 M n . 
     
     
         42 . The method of  claim 36 , wherein the low molecular weight biocompatible polymer has a melt flow rate from 18 g/10 min to 50 g/10 min. 
     
     
         43 . The method of  claim 36 , wherein the biocompatible polymer comprises 60-80% by weight of the extrudable material. 
     
     
         44 . The method of  claim 36 , wherein the bioactive glass is 45S5 or Combeite. 
     
     
         45 . The method of  claim 36 , wherein the bioactive glass has a particle size range from 1 μm to 500 μm. 
     
     
         46 . The method of  claim 36 , wherein the bioactive glass has a particle size of less than 300 μm. 
     
     
         47 . The method of  claim 36 , wherein the bioactive glass has a particle size of less than 150 μm. 
     
     
         48 . The method of  claim 36 , wherein the bioactive glass comprises from 5% to 50% by weight of the extrudable material. 
     
     
         49 . The method of  claim 36 , wherein the bioactive glass comprises from 20% to 40% by weight of the extrudable material. 
     
     
         50 . The method of  claim 36 , wherein the biocompatible polymer is PEEK and the bioactive glass is Combeite. 
     
     
         51 . The method of  claim 36 , wherein the composite further comprises an agent. 
     
     
         52 . The method of  claim 51 , wherein the agent is at least one selected from the group consisting of a reinforcing fiber, carbon, a radiopaque material, barium glass, barium sulfate, barium-boroaluminosilicate (BBAS) glass, silica and an e-glass fiber. 
     
     
         53 . The method of  claim 51 , wherein the agent is a calcium phosphate, strontium or silver material. 
     
     
         54 . The method of  claim 51 , wherein the agent is a radiopacifying agent. 
     
     
         55 . The method of  claim 36 , wherein the bioactive composite includes a surface area and wherein the bioactive glass comprises from 5% to 30% of the surface area of the composite. 
     
     
         56 . The method of  claim 36 , wherein the bioactive composite has a volume and a surface area and wherein the bioactive glass has edges that form a perimeter for each glass particle, wherein a mean particle to particle distance measured between the edges of the bioactive glass throughout the volume and along the surface area of the bioactive composite is between about 80 μm and 180 μm. 
     
     
         57 . The method of  claim 36 , wherein the composite has a compressive strength of at least 110 MPa and a compressive modulus of at least 3.5 GPa. 
     
     
         58 . The method of  claim 36 , wherein the biocompatible polymer comprises from 50% to 85% by weight of the extrudable material and the bioactive glass comprises from 15% to 50% by weight of the extrudable material. 
     
     
         59 . The method of  claim 36 , wherein the biocompatible polymer comprises from 65% to 80% by weight of the extrudable material and the bioactive glass comprises from 20% to 35% by weight of the extrudable material. 
     
     
         60 . The method of  claim 36 , wherein the biocompatible polymer comprises from 70% to 80% by weight of the extrudable material and the bioactive glass comprises from 20% to 30% by weight of the extrudable material. 
     
     
         61 . The method of  claim 36 , wherein the biocompatible polymer comprises 50-90% by weight of the composite, the bioactive glass comprises 5-50% by weight of the composite and the agent comprises 5-50% by weight of the composite. 
     
     
         62 . The method of  claim 36 , wherein the extrudable material further comprises a coupling agent. 
     
     
         63 . The method of  claim 36 , wherein the coupling agent is a silane. 
     
     
         64 . The method of  claim 36 , further comprising the step of molding the bioactive composite into a shaped form for implantation into a patient. 
     
     
         65 . The method of  claim 36 , further comprising the step of machining the shaped form to further expose the bioactive glass prior to implantation into the patient. 
     
     
         66 . The method of  claim 36 , wherein the extruder is a screw extruder. 
     
     
         67 . The method of  claim 36 , wherein the screw extruder is a single screw extruder. 
     
     
         68 . The method of  claim 36 , wherein the screw extruder is a twin screw extruder. 
     
     
         69 . The method of  claim 36 , wherein the screw extruder is a double hopper extruder. 
     
     
         70 . The method of  claim 36 , wherein the screw extruder is a triple hopper extruder. 
     
     
         71 . The method of  claim 36 , wherein the biocompatible polymer and the bioactive glass are added separately to the injection molder. 
     
     
         72 . The method of  claim 36 , wherein the energy is heat. 
     
     
         73 . The method of  claim 36 , wherein the method further comprises the step of injecting the melt mix into a mold to form a shaped bioactive composite. 
     
     
         74 . A method of preparing a bioactive composite, the method comprising the steps of:
 a) adding in a solid state PEEK and Combeite to a screw extruder to form an extrudable material; wherein the PEEK has a particle size range from greater than 400 μm to 4,000 μm, and wherein the PEEK has a molecular weight from 70,000 to 110,000 M n , and wherein the PEEK comprises from 70% to 85% by weight of the extrudable material, and wherein the Combeite has a particle size range from 1 μm to 500 μm, and wherein the Combeite comprises from 15% to 30% by weight of the extrudable material; and   b) applying heat to the extrudable material to at least the melting temperature of the PEEK to melt mix the PEEK and Combeite; and   c) extruding a bioactive composite.   
     
     
         75 . A bioactive composite made by the method of  claim 74 . 
     
     
         76 . A shaped bioactive composite made by the method of  claim 74 . 
     
     
         77 . A spinal implant made by the method of  claim 74 . 
     
     
         78 . A spinal implant having an integrated screw hole made by the method of  claim 74 . 
     
     
         79 . A joint implant made by the method of  claim 74 . 
     
     
         80 . A dental implant made by the method of  claim 74 . 
     
     
         81 . A screw made by the method of  claim 74 . 
     
     
         82 . A cannulated screw made by the method of  claim 74 . 
     
     
         83 . A self-tapping screw made by the method of  claim 74 . 
     
     
         84 . A staple made by the method of  claim 74 . 
     
     
         85 . A pellet made by the method of  claim 74 . 
     
     
         86 . A method for fusing two adjacent vertebral bodies of the spine comprising the steps of:
 a) surgically exposing two vertebral bodies;   b) removing disc material between the two vertebral bodies; and   c) inserting a spinal implant between the two vertebral bodies in the disc space so that a top surface of the implant contacts a first of the two vertebral bodies and a bottom surface of the implant contacts a second of the two vertebral bodies, wherein the spinal implant comprises a biocompatible polymer and a bioactive glass.   
     
     
         87 . A method for repairing a defect in bone comprising the step of administering to the bone an implant comprising a biocompatible polymer and a bioactive glass, wherein the biocompatible polymer has a particle size range from greater than about 400 um to 4000 um prior to formation of said implant 
     
     
         88 . A method for repairing a damaged bone or tooth comprising placing in the bone or jaw an implant comprising a biocompatible polymer and a bioactive glass, wherein the biocompatible polymer has a particle size range from greater than about 400 um to 4000 um prior to formation of said implant. 
     
     
         89 . A method of inserting a dental implant into a bone structure, comprising the steps of:
 a) dissecting a tissue layer overlying the bone structure to provide a flap of tissue and expose a portion of the bone structure;   b) forming a cavity in the exposed portion of the bone structure;   inserting a shaped implant into the cavity, wherein the shaped implant is comprised of a biocompatible polymer and a bioactive glass, wherein the biocompatible polymer has a particle size range from greater than about 400 um to 4000 um prior to formation of said dental implant.   
     
     
         90 . A method for replacing a diseased or dysfunctional hip joint comprising the steps of: resecting a femoral head to expose a femoral intramedullary canal; and inserting a bioactive hip stem into the intramedullary canal for fixation thereto, wherein the hip stem is comprised of a biocompatible polymer and a bioactive glass, wherein the biocompatible polymer has a particle size range from greater than about 400 um to 4000 um prior to formation of said bioactive hip stern. 
     
     
         91 . An injection moldable composition comprising a bioactive composite pellet, wherein the pellet is comprised of a polymer and bioactive glass, the polymer comprising from 50% to 85% by weight of the composition and the bioactive glass comprising from 15% to 50% by weight of the composition. 
     
     
         92 . The injection moldable composition of  claim 91  wherein the composite pellet has a size range from about 400 μm to about 4000 μm. 
     
     
         93 . The injection moldable composition of  claim 91  wherein the composite pellet has a size range from about 1000 μm to about 4000 μm. 
     
     
         94 . A method of enhancing bone bonding properties of PEEK comprising the steps of:
 a) adding in a solid state PEEK and Combeite to a screw extruder to form an extrudable material; wherein the Combeite has a particle size range from 1 μm to 300 μm, and wherein the Combeite comprises from 10% to 50% by weight of the extrudable material; and   b) applying heat to the extrudable material to at least the melting temperature of the PEEK to melt mix the PEEK and Combeite; and   c) extruding a bioactive composite.   
     
     
         95 . The method of  claim 94  wherein the PEEK has a molecular weight from 70,000 to 110,000 M n , and wherein the PEEK comprises from 50% to 90% by weight of the extrudable material. 
     
     
         96 . A method that facilitates the mechanical interlock of a bioactive composite implant to bone comprising the steps of:
 a) implanting in host bone of an animal a composite implant comprised of PEEK and Combeite bioactive glass particles having a particle size range from 1 μm to 300 μm, wherein at least 50% of the Combeite bioactive glass particles have a particle size from about 50 μm to 300 μm; and   b) allowing the implant to remain adjacent the host bone a period of time sufficient to enable the bioactive glass particles to react with the host bone, thereby facilitating the mechanical interlock of the bioactive composite to the bone.   
     
     
         97 . The method of  claim 96  wherein the Combeite comprises from 20% to 30% by weight of the composite implant.