# US 10,945,854 B2 · Porous composite biomaterials and related methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,945,854 B2 - Document ID: US10945854B2 - Status: Granted - Kind: B2 - Application number: 14/078,614 - Filed: 2013-11-13 - Published: 2014-08-21 - Granted: 2021-03-16 - Earliest claimed: 2007-02-28 - Assignees: Happe Spine LLC - Applicants: Ryan K Roeder; Gabriel L Converse; Stephen M Smith - Inventors: Ryan K Roeder; Gabriel L Converse; Stephen M Smith - Web page: https://patentgrep.com/patent/US10945854B2 ## CPC - 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 2/28: Bones - A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine} - A61L 27/12: Phosphorus-containing materials, e.g. apatite - A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 27/26: Mixtures of macromolecular compounds - A61L 27/46: with phosphorus-containing inorganic fillers - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 27/56: Porous materials, {e.g. foams or sponges} - B29C 67/202: {comprising elimination of a solid or a liquid ingredient} - C08J 9/0066: {Use of inorganic compounding ingredients} - C08J 9/28: by elimination of a liquid phase from a macromolecular composition or article, e.g. drying of coagulum - C08J 9/36: After-treatment (C08J9/22 takes precedence) - A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping} - A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]} - A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material} - A61F 2002/30006: {differing in density or specific weight} - A61F 2002/30011: {differing in porosity} - A61F 2002/30032: {differing in absorbability or resorbability, i.e. in absorption or resorption time} - A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive} - A61F 2002/30065: {thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled} - A61F 2002/30225: {Flat cylinders, i.e. discs} - A61F 2002/30235: {tubular, e.g. sleeves} - A61F 2002/30622: {Implant for fusing a joint or bone material} - A61F 2002/30904: {serrated profile, i.e. saw-toothed} - A61F 2002/3092: {having an open-celled or open-pored structure} - A61F 2002/30957: {using a positive or a negative model, e.g. moulds} - A61F 2210/0004: bioabsorbable - A61F 2210/0071: thermoplastic - A61F 2230/0069: cylindrical - A61F 2250/0015: differing in density or specific weight - A61F 2250/0018: differing in elasticity, stiffness or compressibility - A61F 2250/0023: differing in porosity - A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts - 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) - 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) - 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) - C08J: WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H (working, e.g. shaping, of plastics B29) ## Abstract Synthetic composite materials for use, for example, as orthopedic implants are described herein. In one example, a composite material for use as a scaffold includes a thermoplastic polymer forming a porous matrix that has continuous porosity and a plurality of pores. The porosity and the size of the pores are selectively formed during synthesis of the composite material. The example composite material also includes a plurality of a anisometric calcium phosphate particles integrally formed, embedded in, or exposed on a surface of the porous matrix. The calcium phosphate particles provide one or more of reinforcement, bioactivity, or bioresorption. ## Claims ### Claim 1 A porous reinforced composite scaffold material, comprising: a polyaryletherketone polymer, and a plurality of anisometric reinforcement particles comprising calcium phosphate crystals distributed essentially uniformly throughout the polyaryletherketone polymer; wherein the reinforced composite scaffold material comprises a substantially continuously interconnected plurality of pores that are uniformly distributed throughout the polyaryletherketone polymer, each of the pores in the plurality of pores defined by voids interconnected by struts, and having a size within the range from about 10 to 500 μm, and wherein anisometric reinforcement particles are both embedded within the polyaryletherketone polymer and exposed on the struts within the pore voids, and wherein the anisometric reinforcement particles are present from about 1 to about 60%, by volume, in the polyaryletherketone polymer, and wherein the scaffold is formed by mixing particles of the polymer, reinforcement particles, and particles of a porogen within a fluid to obtain a substantially uniform mixture, removing the fluid, molding the particle mixture at a temperature from between 20 to 400 degrees C., and removing the porogen particles. ### Claim 2 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the porosity ranges between 1 to 95 percent by volume. ### Claim 3 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the anisometric reinforcement particles comprise one or more of hydroxyapatite, calcium-deficient hydroxyapatite, carbonated calcium hydroxyapatite, beta-tricalcium phosphate (beta-TCP), alpha-tricalcium phosphate (alpha-TCP), amorphous calcium phosphate (ACP), octacalcium phosphate (OCP), tetracalcium phosphate, biphasic calcium phosphate (BCP), anhydrous dicalcium phosphate (DCPA), dicalcium phosphate dihydrate (DCPD), anhydrous monocalcium phosphate (MCPA), monocalcium phosphate monohydrate (MCPM), and combinations thereof, and, wherein the polyaryletherketone polymer comprises one or more of polyetheretherketone (PEEK), polyetherketonekteone (PEKK), and polyetherketone (PEK). ### Claim 4 (depends on 3) A porous reinforced composite scaffold material as described in claim 3, wherein the anisometric reinforcement particles comprise hydroxyapatite whiskers, and wherein the scaffold comprises between 1 to 50 percent by volume of hydroxyapatite whiskers. ### Claim 5 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the anisometric reinforcement particles have a mean aspect ratio (length along c-axis/length along a-axis) of greater than 1 and less than 100. ### Claim 6 (depends on 5) The porous reinforced composite scaffold material according to claim 5, wherein the size of the anisometric reinforcement particles ranges between 20 nm and 2 mm. ### Claim 7 (depends on 5) The porous reinforced composite scaffold material according to claim 5, comprising one or more additives selected from growth factors, transcription factors, matrix metalloproteinases, peptides, proteins, bone cells, progenitor cells, blood plasma, bone marrow aspirate, and combinations thereof, and wherein the one or more additives coat the scaffold material, or are contained within some or all of the pore void space, or combinations of these. ### Claim 8 (depends on 7) The porous reinforced composite scaffold material according to claim 7, comprising a Bone Morphogenetic Protein (BMP). ### Claim 9 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the scaffold material is part of a synthetic bone graft, a bone ingrowth surface applied to an existing implant, or tissue scaffold. ### Claim 10 (depends on 5) The porous reinforced composite scaffold material according to claim 5, wherein the porosity is either variable or uniform from a center of the material to an exterior surface. ### Claim 11 (depends on 10) The porous reinforced composite scaffold material as described in according to claim 10, wherein the porosity is either functionally graded radially from a highly porous center to a relatively dense exterior surface or functionally graded radially from a relatively dense center to a highly porous exterior surface. ### Claim 12 (depends on 1) The porous reinforced composite scaffold material according to claim 1, further comprising one or a plurality of any one or combination of features selected from holes, notches, pins, radiographic markers, and gripping features. ### Claim 13 A porous reinforced composite scaffold material, comprising: a polyaryletherketone polymer and a plurality of anisometric reinforcement particles distributed essentially uniformly throughout the polyaryletherketone polymer, wherein the reinforced composite scaffold material comprises a substantially continuously interconnected plurality of pores that are uniformly distributed throughout the polyaryletherketone polymer, the pores defined by voids interconnected by struts; and wherein each of the pores in the plurality of pores has a size within the range from about 10 to 500 μm; and wherein at least a portion of the plurality of anisometric reinforcement particles are embedded in and extend from a strut surface into a pore void; and wherein the anisometric reinforcement particles are present from about 1 to about 60%, by volume, in the polyaryletherketone polymer, and wherein the scaffold is formed by mixing particles of the polymer, reinforcement, and a porogen within a fluid to obtain a substantially uniform mixture, removing the fluid, molding the particle mixture at a temperature from between 20 to 400 degrees C., and removing the porogen; and wherein the porous reinforced composite scaffold material has a compressive elastic modulus similar to that of trabecular bone. ### Claim 14 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the porogen particles that are mixed with the polymer particles and the reinforcement particles are either homogenous or heterogeneous in shape and are either homogeneous or heterogeneous in size, the porogen particle size within the range from about 10 to 500 μm. ### Claim 15 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein each of the pores in the plurality of pores has a void size and shape defined by the removed porogen particles. ### Claim 16 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the porogen particles are selected from the group consisting of NaCl, wax, polysaccharides, cellulose, and combinations thereof. ### Claim 17 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the porogen particles have been removed from the porous reinforced composite scaffold material by leaching. ### Claim 18 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the pore struts comprise a textured surface that is defined by the anisometric reinforcement particles that are both embedded within the polyaryletherketone polymer and exposed on the struts. ### Claim 19 (depends on 18) The porous reinforced composite scaffold material according to claim 18, wherein the textured surface of the pores comprises a plurality of anisometric reinforcement particles oriented on the surface of the polyaryletherketone polymer. ### Claim 20 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the textured surface of the pores comprises a plurality of anisometric reinforcement particles oriented on the surface of the polyaryletherketone polymer. ### Claim 21 (depends on 1) The porous reinforced composite scaffold material according to claim 1, wherein the porogen particles have been removed from the composite scaffold material by leaching.