# US 2010/0168798 A1 · Bioactive composites of polymer and glass and method for making same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0168798 A1 - Document ID: US20100168798A1 - Status: Published application - Kind: A1 - Application number: 12/577,835 - Filed: 2009-10-13 - Published: 2010-07-01 - Earliest claimed: 2008-12-30 - Inventors: Theodore D. Clineff; Marissa M. Darmoc; Matthew B. Havener; James P. Murphy; Zachary S. Szczerbinski - Web page: https://patentgrep.com/patent/US20100168798A1 ## CPC - A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46} - A61B 17/742: {having one or more longitudinal elements oriented along or parallel to the axis of the neck} - A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates} - A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)} - A61C 8/0012: {characterised by the material or composition, e.g. ceramics, surface layer, metal alloy (use of specific materials A61K6/00)} - A61C 8/0016: {polymeric material} - A61F 2/28: Bones - A61F 2/2803: {for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071)} - A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)} - A61F 2/30734: {Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect} - A61F 2/30771: {applied in original prostheses, e.g. holes or grooves} - A61F 2/32: for the hip - A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)} - A61F 2/446: {having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones} - A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine} - A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section} - A61F 2/4611: {of spinal prostheses} - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 31/128: {containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127} - B29C 48/022: {characterised by the choice of material} - B29C 48/288: {in solid form, e.g. powder or granules} - B29C 48/832: {Heating} - C08K 3/40: Glass - A61F 2002/2882: {Malar or zygomatic implants} - A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive} - A61F 2002/30131: {horseshoe- or crescent- or C-shaped or U-shaped} - A61F 2002/30593: {hollow} - A61F 2002/30738: {Sleeves} - A61F 2002/30787: {inclined obliquely with respect to each other} - A61F 2002/3082: {Grooves} - A61F 2002/30828: {parallel} - A61F 2002/3085: {with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface} - A61F 2002/30892: {parallel} - A61F 2002/448: {comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants} - A61F 2002/4622: {having the shape of a forceps or a clamp} - A61F 2002/4631: {the prosthesis being specially adapted for being cemented} - A61F 2002/4681: {by applying mechanical shocks, e.g. by hammering} - A61F 2210/0004: bioabsorbable - A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped - A61F 2310/00329: Glasses, e.g. bioglass - A61L 2430/02: for reconstruction of bones; weight-bearing implants - A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs - B29B 9/06: in the form of filamentary material, e.g. combined with extrusion - B29B 9/12: characterised by structure or composition - B29C 45/0001: {characterised by the choice of material} - B29K 2071/00: Use of polyethers {, e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof}, as moulding material - B29K 2105/126: {Whiskers, i.e. reinforcement in the form of monocrystals} - B29K 2105/16: Fillers - B29K 2509/08: Glass - B29K 2995/0056: Biocompatible, e.g. biopolymers or bioelastomers - B29L 2031/7532: {Artificial members, protheses} - C08G 2650/40: containing ketone groups, e.g. polyarylethylketones, PEEK or PEK - C08K 2201/005: Additives being defined by their particle size in general - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - C08K: Use of inorganic or non-macromolecular organic substances as compounding ingredients (paints, inks, varnishes, dyes, polishes, adhesives C09) - B29B: PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES - C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The bioactive composite of claim 1, wherein the biocompatible polymer is an polyaryletherketone polymer. ### Claim 3 (depends on 1) The bioactive composite of claim 1, wherein the biocompatible polymer is polyetheretherketone (PEEK). ### Claim 4 (depends on 1) The bioactive composite of claim 1, wherein the biocompatible polymer is low molecular weight biocompatible polymer. ### Claim 5 (depends on 4) The bioactive composite of claim 4, wherein the low molecular weight biocompatible polymer has a molecular weight from 70,000 to 100,000 Mn. ### Claim 6 (depends on 4) 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. ### Claim 7 (depends on 1) The bioactive composite of claim 1, wherein the biocompatible polymer comprises 60-80% by weight of the composite composition. ### Claim 8 (depends on 1) The bioactive composite of claim 1, wherein the bioactive glass is 45S5 or Combeite. ### Claim 9 (depends on 1) The bioactive composite of claim 1, wherein the bioactive glass has a particle size range from 1 μm to 500 μm. ### Claim 10 (depends on 1) The bioactive composite of claim 1, wherein the bioactive glass has a particle size of less than 300 μm. ### Claim 11 (depends on 1) The bioactive composite of claim 1, wherein the bioactive glass has a particle size of less than 150 μm. ### Claim 12 (depends on 1) The bioactive composite of claim 1, wherein the bioactive glass comprises from 5% to 50% by weight of the composite composition. ### Claim 13 (depends on 1) The bioactive composite of claim 1, wherein the bioactive glass comprises from 20% to 40% by weight of the composite composition. ### Claim 14 (depends on 1) The bioactive composite of claim 1, wherein the biocompatible polymer is PEEK and the bioactive glass is Combeite. ### Claim 15 (depends on 1) The bioactive composite of claim 1, wherein the composite further comprises an agent. ### Claim 16 (depends on 15) 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. ### Claim 17 (depends on 15) The bioactive composite of claim 15, wherein the agent is a calcium phosphate, strontium or silver material. ### Claim 18 (depends on 15) The bioactive composite of claim 15, wherein the agent is a radiopacifying agent. ### Claim 19 (depends on 1) 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. ### Claim 20 (depends on 9) 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. ### Claim 21 (depends on 1) 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. ### Claim 22 (depends on 1) 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. ### Claim 23 (depends on 1) 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. ### Claim 24 (depends on 1) 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. ### Claim 25 (depends on 17) 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 ### Claim 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 Mn, 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. ### Claim 27 (depends on 1) A spinal implant comprising the bioactive composite of claim 1. ### Claim 28 (depends on 1) A spinal implant having an integrated screw hole comprising the bioactive composite of claim 1. ### Claim 29 (depends on 1) A joint implant comprising the bioactive composite of claim 1. ### Claim 30 (depends on 1) A dental implant comprising the bioactive composite of claim 1. ### Claim 31 (depends on 1) A screw comprising the bioactive composite of claim 1. ### Claim 32 (depends on 1) A cannulated screw comprising the bioactive composite of claim 1. ### Claim 33 (depends on 1) A self-tapping screw comprising the bioactive composite of claim 1. ### Claim 34 (depends on 1) A staple comprising the bioactive composite of claim 1. ### Claim 35 (depends on 1) A pellet comprising the bioactive composite of claim 1. ### Claim 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. ### Claim 37 (depends on 36) The method of claim 36, wherein the biocompatible polymer has a particle size of greater than 400 μm to 4,000 μm. ### Claim 38 (depends on 36) The method of claim 36, wherein the biocompatible polymer is an polyaryletherketone polymer. ### Claim 39 (depends on 36) The method of claim 36, wherein the biocompatible polymer is PEEK. ### Claim 40 (depends on 36) The method of claim 36, wherein the biocompatible polymer is low molecular weight biocompatible polymer. ### Claim 41 (depends on 36) The method of claim 36, wherein the low molecular weight biocompatible polymer has a molecular weight from 70,000 to 100,000 Mn. ### Claim 42 (depends on 36) 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. ### Claim 43 (depends on 36) The method of claim 36, wherein the biocompatible polymer comprises 60-80% by weight of the extrudable material. ### Claim 44 (depends on 36) The method of claim 36, wherein the bioactive glass is 45S5 or Combeite. ### Claim 45 (depends on 36) The method of claim 36, wherein the bioactive glass has a particle size range from 1 μm to 500 μm. ### Claim 46 (depends on 36) The method of claim 36, wherein the bioactive glass has a particle size of less than 300 μm. ### Claim 47 (depends on 36) The method of claim 36, wherein the bioactive glass has a particle size of less than 150 μm. ### Claim 48 (depends on 36) The method of claim 36, wherein the bioactive glass comprises from 5% to 50% by weight of the extrudable material. ### Claim 49 (depends on 36) The method of claim 36, wherein the bioactive glass comprises from 20% to 40% by weight of the extrudable material. ### Claim 50 (depends on 36) The method of claim 36, wherein the biocompatible polymer is PEEK and the bioactive glass is Combeite. ### Claim 51 (depends on 36) The method of claim 36, wherein the composite further comprises an agent. ### Claim 52 (depends on 51) 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. ### Claim 53 (depends on 51) The method of claim 51, wherein the agent is a calcium phosphate, strontium or silver material. ### Claim 54 (depends on 51) The method of claim 51, wherein the agent is a radiopacifying agent. ### Claim 55 (depends on 36) 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. ### Claim 56 (depends on 36) 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. ### Claim 57 (depends on 36) 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. ### Claim 58 (depends on 36) 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. ### Claim 59 (depends on 36) 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. ### Claim 60 (depends on 36) 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. ### Claim 61 (depends on 36) 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. ### Claim 62 (depends on 36) The method of claim 36, wherein the extrudable material further comprises a coupling agent. ### Claim 63 (depends on 36) The method of claim 36, wherein the coupling agent is a silane. ### Claim 64 (depends on 36) The method of claim 36, further comprising the step of molding the bioactive composite into a shaped form for implantation into a patient. ### Claim 65 (depends on 36) 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. ### Claim 66 (depends on 36) The method of claim 36, wherein the extruder is a screw extruder. ### Claim 67 (depends on 36) The method of claim 36, wherein the screw extruder is a single screw extruder. ### Claim 68 (depends on 36) The method of claim 36, wherein the screw extruder is a twin screw extruder. ### Claim 69 (depends on 36) The method of claim 36, wherein the screw extruder is a double hopper extruder. ### Claim 70 (depends on 36) The method of claim 36, wherein the screw extruder is a triple hopper extruder. ### Claim 71 (depends on 36) The method of claim 36, wherein the biocompatible polymer and the bioactive glass are added separately to the injection molder. ### Claim 72 (depends on 36) The method of claim 36, wherein the energy is heat. ### Claim 73 (depends on 36) 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. ### Claim 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 Mn, 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. ### Claim 75 (depends on 74) A bioactive composite made by the method of claim 74. ### Claim 76 (depends on 74) A shaped bioactive composite made by the method of claim 74. ### Claim 77 (depends on 74) A spinal implant made by the method of claim 74. ### Claim 78 (depends on 74) A spinal implant having an integrated screw hole made by the method of claim 74. ### Claim 79 (depends on 74) A joint implant made by the method of claim 74. ### Claim 80 (depends on 74) A dental implant made by the method of claim 74. ### Claim 81 (depends on 74) A screw made by the method of claim 74. ### Claim 82 (depends on 74) A cannulated screw made by the method of claim 74. ### Claim 83 (depends on 74) A self-tapping screw made by the method of claim 74. ### Claim 84 (depends on 74) A staple made by the method of claim 74. ### Claim 85 (depends on 74) A pellet made by the method of claim 74. ### Claim 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. ### Claim 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 ### Claim 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. ### Claim 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. ### Claim 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. ### Claim 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. ### Claim 92 (depends on 91) The injection moldable composition of claim 91 wherein the composite pellet has a size range from about 400 μm to about 4000 μm. ### Claim 93 (depends on 91) The injection moldable composition of claim 91 wherein the composite pellet has a size range from about 1000 μm to about 4000 μm. ### Claim 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. ### Claim 95 (depends on 94) The method of claim 94 wherein the PEEK has a molecular weight from 70,000 to 110,000 Mn, and wherein the PEEK comprises from 50% to 90% by weight of the extrudable material. ### Claim 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. ### Claim 97 (depends on 96) The method of claim 96 wherein the Combeite comprises from 20% to 30% by weight of the composite implant.