Claims for Patent: 7,005,136

Summary for Patent: 7,005,136

Title:	Bone replacement materials utilizing bioabsorbable liquid polymers
Abstract:	The present invention is directed to bone replacement devices and compositions containing a synthetic, bioabsorbable, biocompatible liquid polymer that is the reaction product of a polybasic acid or derivative thereof, a polyol and a fatty acid, the liquid polymer having a melting point less than about 40.degree. C., as determined by differential scanning calorimetry.
Inventor(s):	Nathan; Aruna (Bridgewater, NJ), Melican; Mora C. (Bridgewater, NJ), Brown; Kelly R. (Hillsborough, NJ), Zimmerman; Mark C. (East Brunswick, NJ)
Assignee:	Ethicon, Inc. (Somerville, NJ)
Application Number:	10/112,554
Patent Claims:	1. A medical device, comprising: a bone replacement material, said bone replacement material comprising a synthetic, bioabsorbable, biocompatible liquid polymer comprising the reaction product of a polybasic acid or derivative thereof, a fatty acid, and a polyol, said liquid polymer comprising an aliphatic polyester backbone having fatty acid ester groups pending therefrom and said liquid polymer having a melting point less than about 40.degree. C., as determined by differential scanning calorimetry wherein said polybasic acid or derivative thereof is selected from the group consisting of succinic acid, succinic anhydride, malic acid, tartaric acid, citric acid, diglycolic acid, diglycolic anhydride, glutaric acid, glutaric anhydride, adipic acid, pimelic acid, suberic acid, sebacic acid, fumaric acid, maleic acid, maleic anhydride, mixed anhydrides, esters, activated esters, and acid halides. 2. The medical device of claim 1 wherein said liquid polymer comprises the reaction product of said polybasic acid or derivative thereof and a monoglyceride, said monoglyceride comprising the reaction product of said fatty acid and said polyol. 3. The medical device of claim 2 wherein said polybasic acid or derivative thereof is selected from the group consisting of succinic acid, succinic anhydride, malic acid, tartaric acid, citric acid, diglycolic acid, diglycolic anhydride, glutaric acid, glutaric anhydride, adipic acid, pimelic acid, suberic acid, sebacic acid, fumaric acid, maleic acid, maleic anhydride, mixed anhydrides, esters, activated esters and acid halides. 4. The medical device of claim 3 wherein said polybasic acid derivative is succinic anhydride. 5. The medical device of claim 3 wherein said polybasic acid is succinic acid. 6. The medical device of claim 1 wherein said liquid polymer comprises a liquid copolymer. 7. The medical device of claim 6 wherein said liquid copolymer comprises the reaction product of said fatty acid, said polyol, and at least two of said polybasic acids or derivatives thereof selected from the group consisting of succinic acid, succinic anhydride, malic acid, tartaric acid, citric acid, diglycolic acid and diglycolic anhydride. 8. The medical device of claim 6 wherein said liquid copolymer comprises the reaction product of said polybasic acid or derivative thereof, and at least two monoglycerides selected from the group consisting of monostearoyl glycerol, monopalmitoyl glycerol, monomyrisitoyl glycerol, monocaproyl glycerol, monodecanoyl glycerol, monolauroyl glycerol, monolinoleoyl glycerol and monooleoyl glycerol. 9. The medical device of claim 6 wherein said liquid copolymer comprises the reaction product of said polybasic acid or derivative thereof, a monoglyceride selected from the group consisting of monostearoyl glycerol, monopalmitoyl glycerol, monomyrisitoyl glycerol, monocaproyl glycerol, monodecanoyl glycerol, monolauroyl glycerol, monolinoleoyl glycerol and monooleoyl glycerol, and at least one additional polyol selected from the group consisting of ethylene glycol, 1,2-propylene glycol, 1,3-propanediol, bis-2-hydroxyethyl ether, 1,4-butanediol, 1,5-pentanediol, 1,6-hexanediol, 1,8-octanediol, 1,10-decanediol, 1,12-dodecanediol, other diols, linear poly(ethylene glycol), branched poly(ethylene glycol), linear poly(propylene glycol), branched poly(propylene glycol), linear poly(ethylene-co-propylene glycol)s and branched poly(ethylene-co-propylene glycol)s. 10. The medical device of claim 1 further comprising an inorganic filler. 11. The medical device of claim 11 wherein said inorganic filler is selected from the group consisting of alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate and hydroxyapatite. 12. The medical device of claim 10 wherein said inorganic filler comprises a polymorph of calcium phosphate. 13. The medical device of claim 10 wherein said inorganic filler is hydroxyapatite. 14. The medical device of claim 10 further comprising a therapeutically effective amount of a bioactive agent. 15. The medical device of claim 14 wherein said bioactive agent is a growth factor. 16. The medical device of claim 15 wherein said growth factor is selected from the group consisting of cell attachment mediators, biologically active ligands, integrin binding sequence, bone morphogenic proteins, epidermal growth factor, fibroblast growth factor, platelet-derived growth factor, IGF-I, IGF-II, TGF-.beta. I-III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, hyaluronic acid, glycoprotein, lipoprotein, bFGF, TGF.sub..beta.superfamily factors, BMP-2, BMP-4, BMP-6, BMP-12, sonic hedgehog, GDF5, GDF6, GDF8, PDGF, tenascin-C, fibronectin, thromboelastin, and thrombin-derived peptides. 17. The medical device of claim 10 further comprising a biologically derived substance selected from the group consisting of demineralized bone, platelet rich plasma, bone marrow aspirate and bone fragments. 18. The medical device of claim 1 further comprising a therapeutically effective amount of a bioactive agent. 19. The medical device of claim 18 wherein said bioactive agent is a growth factor. 20. The medical device of claim 19 wherein said growth factor is selected from the group consisting of cell attachment mediators, biologically active ligands, integrin binding sequence, bone morphogenic proteins, epidermal growth factor, fibroblast growth factor, platelet-derived growth factor, IGF-I, IGF-II, TGF-.beta. I-III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, hyaluronic acid, glycoprotein, lipoprotein, bFGF, T6F.sub..beta.superfamily factors, BMP-2, BMP-4, BMP-6, BMP-12, sonic hedgehog, GDF5, GDF6, GDF8, PDGF, tenascin-C, fibronectin, tispoelastin, and thromlin-derived peptides. 21. The medical device of claim 1 wherein said liquid polymer further comprises terminal and pendant chemical moieties prepared by suitable endcapping reactions. 22. The medical device of claim 21 wherein said terminal and pendant chemical moieties are selected from the group consisting of ethers, esters, anhydrides, mixed anhydrides, sulfonates, and urethanes. 23. The medical device of claim 21 further comprising an inorganic filler. 24. The medical device of claim 23 wherein said inorganic filler is selected from the group consisting of alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate and hydroxyapatite. 25. The medical device of claim 23 wherein said inorganic filler comprises a polymorph of calcium phosphate. 26. The medical device of claim 23 wherein said inorganic filler is hydroxyapatite. 27. The medical device of claim 23 further comprising a therapeutically effective amount of a bioactive agent. 28. The medical device of claim 27 wherein said bioactive agent is a growth factor. 29. The medical device of claim 28 wherein said growth factor is selected from the group consisting of cell attachment mediators, biologically active ligands, integrin binding sequence, bone morphogenic proteins, epidermal growth factor, fibroblast growth factor, platelet-derived growth factor, IGF-I, IGF-II, TGF-.beta. I-III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, hyaluronic acid, glycoprotein and lipoprotein. 30. The medical device of claim 21 further comprising a biologically derived substance selected from the group consisting of demineralized bone, platelet rich plasma, bone marrow aspirate and bone fragments. 31. The medical device of claim 21 further comprising a therapeutically effective amount of a bioactive agent. 32. The medical device of claim 31 wherein said bioactive agent is a growth factor. 33. The medical device of claim 32 wherein said growth factor is selected from the group consisting of cell attachment mediators, biologically active ligands, integrin binding sequence, bone morphogenic proteins, epidermal growth factor, fibroblast growth factor, platelet-derived growth factor, IGF-I, IGF-II, TGF-.beta. I-III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, hyaluronic acid, glycoprotein and lipoprotein. 34. A bone replacement composition, comprising: a liquid polymer comprising the reaction product of a polybasic acid or derivative thereof, a fatty acid and a polyol, said liquid polymer comprising an aliphatic polyester backbone having fatty acid ester groups vending therefrom and said liquid polymer having a melting point less than about 40.degree. C., as determined by differential scanning calorimetry wherein said polybasic acid or derivative thereof is selected from the group consisting of succinic acid succinic anhydride, malic acid, tartaric acid, citric acid, diglycolic acid diglycolic anhydride, glutaric acid, glutaric anhydride, adipic acid, pimelic acid, suberic acid, sebacic acid, fumaric acid, maleic acid, maleic anhydride, mixed anhydrides, esters, activated esters, and acid halides. 35. The composition of claim 34 further comprising an inorganic filler. 36. The composition of claim 35 wherein said inorganic filler is selected from the group consisting of alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate, a polymorph of calcium phosphate and hydroxyapatite. 37. The composition of claim 34 further comprising a therapeutically effective amount of a bioactive agent. 38. The composition of claim 37 wherein said bioactive agent is a growth factor. 39. The composition of claim 38 wherein said growth factor is selected from the group consisting of cell attachment mediators, biologically active ligands, integrin binding sequence, bone morphogenic proteins, epidermal growth factor, fibroblast growth factor, platelet-derived growth factor, IGF-I, IGF-II, TGF-.beta. I.beta.III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, hyaluronic acid, glycoprotein, lipoprotein, bFGF, TGF.sub..beta.superfamily factors, BMP-2, BMP-4, BMP-6, BMP-12, sonic hedgehog, GDF5, GDF6, GDF8, PDGF, tenascin-C, fibronectin, thromboelastin, and thrombin-derived peptides. 40. The composition of claim 34 further comprising a biologically derived substance selected from the group consisting of demineralized bone, platelet rich plasma, bone marrow aspirate and bone fragments.

Details for Patent 7,005,136

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-03-29