A polymer scaffold is provided comprising an extensively interconnected macroporous network. The polymer scaffold embodies macropores having a diameter in a range of 0.5-3.5 mm, and preferably in a range of about 1.0-2.0 mm. The polymer scaffold is prepared using a novel process which advantageously
A polymer scaffold is provided comprising an extensively interconnected macroporous network. The polymer scaffold embodies macropores having a diameter in a range of 0.5-3.5 mm, and preferably in a range of about 1.0-2.0 mm. The polymer scaffold is prepared using a novel process which advantageously combines the techniques of particulate leaching and phase inversion to render a process that provides amplified means by which to control the morphology of the resulting polymer scaffold. The polymer scaffold has utility in the area of tissue engineering, particularly as a scaffold for both in vitro and in vivo cell growth. The polymer scaffold may be produced using pure polymer or alternatively a composite material may be formed consisting of a macroporous polymer scaffold and osteoclast-resorbable calcium phosphate particles with a binding agent binding the calcium phosphate particles to the polymer scaffold.
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Therefore what is claimed is: 1. A composite material formed of a macroporous polymer scaffold and calcium phosphate particles, said macroporous polymer scaffold comprising essentially non-membraneous pore walls, said pore walls consisting of microporous polymer struts defining macropores which are
Therefore what is claimed is: 1. A composite material formed of a macroporous polymer scaffold and calcium phosphate particles, said macroporous polymer scaffold comprising essentially non-membraneous pore walls, said pore walls consisting of microporous polymer struts defining macropores which are interconnected by macroporous passageways, said microporous polymer struts containing calcium phosphate particles dispersed therethrough and a binding agent for binding said calcium phosphate particles to a polymer making up said macroporous polymer scaffold, microporous passageways extending through said microporous polymer struts so that macropores on either side of a given microporous polymer strut are in communication through said given microporous polymer strut, said macropores having a mean diameter in a range from about 0.5 to about 3.5 mm, and said macroporous polymer scaffold having a porosity of at least 50%. 2. A composite material as defined in claim 1 wherein said calcium phosphate particles are osteoclast-resorbable calcium phosphate particles. 3. A composite material as defined in claim 2 wherein said binding agent is selected from the group consisting of phosphoproteins, mucopolysaccarides, polyacrylamides, proteoglycans, polyacrylic acid, poly-L-glutamate and poly-L-aspartate, albumin, alginate salts, and physiologically acceptable organic compounds containing an active group selected from a group consisting of--COOH,--SO4H,--PO 4H2,--OH and--NH2. 4. A composite material as defined in claim 3 wherein said proteoglycan is a sialoprotein. 5. A composite material as defined in claim 3 wherein said phosphoprotein is casein. 6. A composite material as defined in claim 3 wherein said mucopolysaccaride is one of chondroitin sulphate, dermatan sulphate and heparan sulphate. 7. A composite material as defined in claim 3 wherein said physiologically acceptable organic compound is one of glycerophosphate and phosphorylated amino acids. 8. A composite material as defined in claim 3 wherein said macroporous passageways connecting macropores have a mean diameter in a range from about 200 μm to about 2 mm, and wherein said microporous passageways have a mean diameter less than about 200 μm. 9. A composite material as defined in claim 8 wherein said microporous polymer struts separating macropores have a thickness of less than 0.4 mm. 10. A composite material as defined in claim 3, which is biocompatible. 11. A composite material as defined in claim 3, which is biodegradable. 12. A composite material as defined in claim 7 wherein the polymer is poly(lactide-co-glycolide). 13. A composite material as defined in claim 12 wherein the polymer comprises poly(lactide-co-glycolide) in a ratio of 75% lactide and 25% glycolide. 14. A composite material as defined in claim 3 wherein said microporous polymer struts separating macropores have a thickness of less than 0.4 mm, and wherein said polymer scaffold is biocompatible and biodegradable, and has a porosity of at least 85%. 15. A composite material as defined in claim 3 wherein said alginate salts are sodium alginate. 16. A process for synthesizing a composite material formed of a macroporous polymer scaffold and calcium phosphate particles, said macroporous polymer scaffold comprising essentially non-membraneous pore walls, said pore walls consisting of microporous polymer struts defining macropores which are interconnected by macroporous passageways, said microporous polymer struts containing calcium phosphate particles dispersed therethrough and a binding agent for binding said calcium phosphate particles to a polymer making up said macroporous polymer scaffold, microporous passageways extending through said microporous polymer struts so that macropores on either side of a given microporous polymer strut are in communication through said given microporous polymer strut, said macropores having a mean diameter in a range from about 0.5 to about 3.5 mm. and said macroporous polymer scaffold having a porosity of at least 50%, comprising the steps of: coating calcium phosphate particles with a binding agent, and drying the coated calcium phosphate particles; mixing the coated calcium phosphate particles with a liquid polymer to form a first mixture; mixing second particles with the first mixture to form a second mixture; submerging the second mixture in a non-solvent for the liquid polymer to precipitate said liquid polymer producing a solidified mixture; and submerging the solidified mixture into a solvent that dissolves the second particles for a time sufficient to dissolve the second particles to obtain said macroporous polymer scaffold with microporous polymer struts defining interconnected macropores and containing therein said calcium phosphate particles. 17. A process as defined in claim 16 wherein said calcium phosphate particles are osteoclast-resorbable calcium phosphate particles. 18. A process as defined in claim 17 wherein said binding agent is selected from the group consisting of phosphoproteins, mucopolysaccarides, polyacrylamides, proteoglycans, polyacrylic acid, poly-L-glutamate and poly-L-aspartate, albumin, alginate salts, and physiologically acceptable organic compounds containing an active group selected from a group consisting of--COOH,--SO4H,--PO 4H2,--OH ,--NH2. 19. A process as defined in claim 18 wherein said proteoglycan is a sialoprotein. 20. A process as defined in claim 18 wherein said phosphoprotein is casein. 21. A process as defined in claim 18 wherein said mucopolysaccaride is one of chondroitin sulphate, dermatan sulphate and heparan sulphate. 22. A process as defined in claim 17 wherein said osteoclast-resorbable calcium phosphate particles have a mean diameter in a range from about 0.05 to about 45 microns. 23. A process as defined in claim 17 wherein said liquid polymer is formed by dissolving a polymer in a polymer solvent. 24. A process as defined in claim 23 wherein said polymer solvent is dimethylsulfoxide. 25. A process as defined in claim 17 wherein second particles have a diameter in the range of about 0.5 mm to about 3.5 mm. 26. A process as defined in claim 25 wherein said second particles have a mean diameter in the range of about 1.0 mm to about 2.0 mm. 27. A process as defined in claim 17 wherein said second particles are selected from the group consisting of polysaccharides, organic salts, inorganic salts, proteins, lipids, and combinations thereof. 28. A process as defined in claim 27 wherein said polysaccharide is glucose. 29. A process as defined in claim 27 wherein said second particles are sugar particles. 30. A process as defined in claim 17 additionally comprising the step of modifying the surface of the polymer scaffold. 31. A process as defined in claim 17 wherein the surface of the polymer scaffold is modified using a treatment selected from the group consisting of acid treatment, base treatment, collagen deposition and calcium phosphate deposition. 32. A process as defined in claim 17 including stabilizing said second mixture prior to precipitating said liquid polymer. 33. A process as defined in claim 32 wherein said second mixture is stabilized by cooling it to a suitable temperature. 34. A process as defined in claim 17 wherein said liquid polymer is formed by heating a polymer to its melting point to liquify said polymer. 35. The process of claim 17 wherein said non-solvent for the polymer is selected from the group consisting of water, alcohol, 1-4 dioxane and aniline. 36. The process of claim 17 wherein said liquid polymer is derived from poly(lactide-co-glycolide). 37. A process as defined in claim 18 wherein said alginate salts are sodium alginate.
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