Solvent based processing technologies for making tissue/polymer composites

• US 20060216321A1
• Filed: 03/24/2005
• Published: 09/28/2006
• Est. Priority Date: 03/24/2005
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Gross, Jeff, Loy, Brian, Kinnane, Matt, Hobot, Chris, Schley, Jim, Haddock, Sean, Lyu, Suping
• Application Number:
  US11/088,957
• Publication Number:
  US 20060216321A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: 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]
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30205 conical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/427 of other specific inorganic materials not covered by A61L27/422 or A61L27/425
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges

Abstract

An improved osteoimplant device and method for producing it. Bone particles are mixed with a polymer and a solvent. The mixture is formed into the shape of an osteoimplant and substantially all of the solvent is removed. The osteoimplant may be osteoinductive, osteoconductive, and load-bearing.

Claims

1. A method for producing an osteoimplant device comprising:

mixing bone material, a solvent, and a polymer that is substantially soluble in the solvent;

forming the mixture into the shape of an osteoimplant; and

removing substantially all of the solvent from the osteoimplant.

2. The method of claim 1, wherein the bone material is selected from the group consisting of autogenic, allogenic, and xenogenic source bone, and combinations and mixtures thereof.

3. The method of claim 1, wherein the bone material is selected from the group consisting of bone powder;

bone granules;

bone chips;

bone shards;

bone flakes;

products of ground, pulverized, and chipped bone; and

combinations and mixtures thereof.

4. The method of claim 1, wherein the bone material comprises nondemineralized source bone, fully demineralized source bone, partially demineralized source bone, and combinations and mixtures thereof.

5. The method of claim 1, wherein the solvent is selected from the group consisting of alcohols, ketones, ethers, esters, chloride solvents, fluoride solvents, aliphatic hydrocarbons, aromatic hydrocarbons, supercritical liquids, and combinations and mixtures thereof.

6. The method of claim 5, wherein the solvent is tetrahydrofuran.

7. The method of claim 1, wherein the polymer is a natural, synthetic, or semi-synthetic polymer.

8. The method of claim 1, wherein the polymer is substantially bioresorbable.

9. The method of claim 7, wherein the natural polymer is selected from the group consisting of fibrin glue, fibrinogen, thrombin, mussel adhesive protein, silk, elastin, collagen, casein, gelatin, albumin, keratin, chitin or chitosan, natural or modified polysaccharides, starches, and combinations and mixtures thereof.

10. The method of claim 7, wherein the synthetic polymer is selected from the group consisting of epoxy-based compounds, polyacrylates, polymethacrylates, fluoropolymers, silicone polymers, polyurethanes, polyesters, polyethers, polyolefins, vinyl polymers, polysulfones, polyacetals, polyimides, polyamides, polycarbonates, bisphenol-A based poly(phosphoesters), polyphenylenesulfides, polyamideimides, polyaryletherketones, polyarylethernitriles, aromatic polyhydroxy-ethers, polyphenyleneoxides, amino acid-derived polycarbonates, amino acid-derived polyarylates, polyarylates derived from dicarboxylic acids and amino acid-derived diphenols, anionic polymers derived from L-tyrosine, polyarylate random block copolymers, and combinations and mixtures thereof.

11. The method of claim 7, wherein the semi-synthetic polymer is selected from the group consisting of genetically-engineered protein polymers, ethyl cellulose, methyl cellulose, carboxy methyl cellulose, hydroxy ethyl cellulose, sodium carboxymethylcellulose, hydroxy propyl cellulose, cellulose esters, and combinations and mixtures thereof.

12. The method of claim 8, wherein the bioresorbable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, polyglycolates, polydioxanone, polycaprolactone, polycarbonates, polyorthoesters, polyamino acids, polyanhydrides, polyhydroxybutyrate, polyhydroxyvalyrate, poly(propylene glycol-co-fumaric acid), polyhydroxyalkanoates, polyphosphazenes, poly(alkylcyanoacrylates), polyarylates, amino acid-based polymers, cellulose, celluose derivatives, and combinations and mixtures thereof.

13. The method of claim 1, wherein substantially all of the solvent is removed from the osteoimplant by freeze drying.

14. The method of claim 1, wherein substantially all of the solvent is removed from the osteoimplant by placing the implant under vacuum.

15. The method of claim 1, wherein substantially all of the solvent is removed from the osteoimplant by heating the implant.

16. The method of claim 1, wherein substantially all of the solvent is removed from the osteoimplant by drying the osteoimplant in circulating air at room temperature.

17. The method of claim 1, further comprising adding a biological agent or additive to the osteoimplant.

18. The method of claim 17, wherein the biological agent or additive is selected from the group consisting of antibiotics, growth factors, fibrin, bone morphogenetic factors, bone growth agents, chemotherapeutics, pain killers, bisphosphonates, strontium salt, fluoride salt, magnesium salt, sodium salt, and combinations and mixtures thereof.

19. The method of claim 1, further comprising adding a reinforcing component to the osteoimplant.

20. The method of claim 19, wherein the reinforcing component is selected from the group consisting of fibers, fibrous webs, woven textiles, nonwoven textiles, mesh, and combinations and mixtures thereof.

21. The method of claim 1, wherein mixing additionally comprises mixing a porosity generation agent.

22. The method of claim 21, wherein the porosity generation agent is selected from the group consisting of sodium chloride, potassium chloride, other inorganic salts, glucose, sugars, other small molecular weight organic compounds, and combinations and mixtures thereof.

23. The method of claim 1, wherein the bone material is treated with a surface treatment agent.

24. The method of claim 23, wherein the surface treatment agent chemically or physically binds to the bone material and polymer.

25. The method of claim 1, wherein forming the mixture into the shape of an osteoimplant comprises a procedure selected from the group consisting of press-molding, injection molding, extrusion, rolling, solvent-casting, gel-casting, cast-molding, vacuum-forming, sintering, melt-forming, blow-molding, leach molding, leavening, and combinations thereof.

26. An osteoimplant device produced by the method of claim 1.

27. The device of claim 26, wherein the osteoimplant is in the form of one or more selected from the group consisting of a sheet, plate, dish, cone, pin, screw, tube, tooth, tooth root, bone, bone portion, wedge, wedge portion, cylinder, dowel, intervertebral implant, suture anchor, and combinations thereof.

28. The device of claim 26, wherein the bone material is selected from the group consisting of autogenic, allogenic, and xenogenic source bone, and combinations and mixtures thereof.

29. The device of claim 26, wherein the bone material is selected from the group consisting of bone powder;

bone granules;

bone chips;

bone shards;

bone flakes;

products of ground, pulverized, and chipped bone; and

combinations and mixtures thereof.

30. The device of claim 26, wherein the bone material comprises nondemineralized source bone, fully demineralized source bone, partially demineralized source bone, and combinations and mixtures thereof.

31. The device of claim 26, wherein the solvent is selected from the group consisting of alcohols, ketones, ethers, esters, chloride solvents, fluoride solvents, aliphatic hydrocarbons, aromatic hydrocarbons, supercritical liquids, and combinations and mixtures thereof.

32. The device of claim 31, wherein the solvent is tetrahydrofuran.

33. The device of claim 26, wherein the polymer is a natural, synthetic, or semi-synthetic polymer.

34. The device of claim 26, wherein the polymer is substantially bioresorbable.

35. The device of claim 33, wherein the natural polymer is selected from the group consisting of fibrin glue, fibrinogen, thrombin, mussel adhesive protein, silk, elastin, collagen, casein, gelatin, albumin, keratin, chitin or chitosan, natural or modified polysaccharides, starches, and combinations and mixtures thereof.

36. The device of claim 33, wherein the synthetic polymer is selected from the group consisting of epoxy-based compounds, polyacrylates, polymethacrylates, fluoropolymers, silicone polymers, polyurethanes, polyesters, polyethers, polyolefins, vinyl polymers, polysulfones, polyacetals, polyimides, polyamides, polycarbonates, bisphenol-A based poly(phosphoesters), polyphenylenesulfides, polyamideimides, polyaryletherketones, polyarylethernitriles, aromatic polyhydroxy-ethers, polyphenyleneoxides, amino acid-derived polycarbonates, amino acid-derived polyarylates, polyarylates derived from dicarboxylic acids and amino acid-derived diphenols, anionic polymers derived from L-tyrosine, polyarylate random block copolymers, and combinations and mixtures thereof.

37. The device of claim 33, wherein the semi-synthetic polymer is selected from the group consisting of genetically-engineered protein polymers, ethyl cellulose, methyl cellulose, carboxy methyl cellulose, hydroxy ethyl cellulose, sodium carboxymethylcellulose, hydroxy propyl cellulose, cellulose esters, and combinations and mixtures thereof.

38. The device of claim 34, wherein the bioresorbable polymer is selected from the group consisting of polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, polyglycolates, polydioxanone, polycaprolactone, polycarbonates, polyorthoesters, polyamino acids, polyanhydrides, polyhydroxybutyrate, polyhydroxyvalyrate, poly(propylene glycol-co-fumaric acid), polyhydroxyalkanoates, polyphosphazenes, poly(alkylcyanoacrylates), polyarylates, amino acid-based polymers, cellulose, celluose derivatives, and combinations and mixtures thereof.

39. The device of claim 26, wherein substantially all of the solvent is removed from the osteoimplant by freeze drying.

40. The device of claim 26, wherein substantially all of the solvent is removed from the osteoimplant by placing the implant under vacuum.

41. The device of claim 26, wherein substantially all of the solvent is removed from the osteoimplant by heating the implant.

42. The device of claim 26, wherein substantially all of the solvent is removed from the osteoimplant by drying the osteoimplant in circulating air at room temperature.

43. The device of claim 26, further comprising adding a biological agent or additive to the osteoimplant.

44. The device of claim 43, wherein the biological agent or additive is selected from the group consisting of antibiotics, growth factors, fibrin, bone morphogenetic factors, bone growth agents, chemotherapeutics, pain killers, bisphosphonates, strontium salt, fluoride salt, magnesium salt, sodium salt, and combinations and mixtures thereof.

45. The device of claim 26, further comprising adding a reinforcing component to the osteoimplant.

46. The device of claim 45, wherein the reinforcing component is selected from the group consisting of fibers, fibrous webs, woven textiles, nonwoven textiles, mesh, and combinations and mixtures thereof.

47. The device of claim 26, wherein mixing additionally comprises mixing a porosity generation agent.

48. The device of claim 47, wherein the porosity generation agent is selected from the group consisting of sodium chloride, potassium chloride, other inorganic salts, glucose, sugars, other small molecular weight organic compounds, and combinations and mixtures thereof.

49. The device of claim 26, wherein the bone material is treated with a surface treatment agent.

50. The device of claim 49, wherein the surface treatment agent chemically or physically binds to the bone material and polymer.

51. The device of claim 26, wherein forming the mixture into the shape of an osteoimplant comprises a procedure selected from the group consisting of press-molding, injection molding, extrusion, rolling, solvent-casting, gel-casting, cast-molding, vacuum-forming, sintering, melt-forming, blow-molding, leach molding, leavening, and combinations thereof.