Bone void filler

• US 20060067971A1
• Filed: 09/27/2004
• Published: 03/30/2006
• Est. Priority Date: 09/27/2004
• Status: Abandoned Application

• Current Assignee: Brooks J. Story, Deborah M. Schachter, Tracy Martellotta
• Original Assignee: Brooks J. Story, Deborah M. Schachter, Tracy Martellotta
• Inventors: Story, Brooks J., Schachter, Deborah M., Martellotta, Tracy
• Application Number:
  US10/950,775
• Publication Number:
  US 20060067971A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 23/02 Local anaesthetics

Abstract

Novel biodegradable bone void filler compositions. The bone void filler compositions have a biodegradable material component, an osteoconductive component, and a therapeutic agent. The bone void filler optionally contains an osteoinductive component. Also disclosed is a method of using the bone void filler compositions to fill a bone void.

Claims

1. A bone void filler composition, comprising:

a biodegradable material component;

an osteoconductive component; and

,

a therapeutically effective amount of a therapeutic agent.

2. The composition of claim 1, wherein said biodegradable material component comprises a polymer selected from the group consisting of poly(glycolide), poly(lactide), poly(epsilon-caprolactone), poly(trimethylene carbonate), poly(para-dioxanone),and combinations thereof.

3. The composition of claim 1, wherein said biodegradable material component comprises a co-polymer selected from the group consisting of poly(lactide-co-glycolide), poly(epsilon-caprolactone-co-glycolide), poly(glycolide-co-trimethylene carbonate), and combinations thereof.

4. The composition of claim 1, wherein said biodegradable material component is selected from the group consisting of albumin, casein, waxes, starch, crosslinked starch, simple sugars, glucose, ficoll, polysucrose, polyvinyl alcohol, gelatine, modified celluloses, carboxymethylcellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl-ethyl cellulose, hydroxypropyl-methyl cellulose, sodium carboxymethyl cellulose, cellulose acetate, sodium alginate, hyaluronic acid, hyaluronic acid derivatives, polyvinyl pyrollidone, polymaleic anhydride esters, polyortho esters, polyethyleneimine, glycols, polyethylene glycol, methoxypolyethylene glycol, ethoxypolyethylene glycol, polyethylene oxide, poly(1,3 bis(p-carboxyphenoxy) propane-co-sebacic anhydride, N,N-diethylaminoacetate, block copolymers of polyoxyethylene and polyoxypropylene, and combinations thereof.

5. The composition of claim 4, wherein said biodegradable material component comprises a member selected from the group consisting of hydroxyethyl cellulose, hyaluronic acid, and hyaluronic acid derivatives

6. The composition of claim 1 wherein said osteoconductive component is selected from the group consisting of tricalcium phosphate, alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate, hydroxyapatite, a polymorph of calcium phosphate, and combinations thereof.

7. The composition of claim 6, wherein said osteoconductive component is beta-tricalcium phosphate.

8. The composition of claim 1, wherein said therapeutic agent is selected from the group consisting of pain medication, antiinfectives, analgesics, anti-inflammatory agents, immunosupressives, steroids, including corticosteroids, glycoproteins, lipoproteins, and combinations thereof.

9. The composition of claim 8, wherein said pain medication is selected from the group consisting of morphine, nonsteroidal anti-inflammatory drugs, oxycodone, morphine, fentanyl, hydrocodone, naproxyphene, codeine, acetaminophen with codeine, acetaminophen, benzocaine, lidocaine, procaine, bupivacaine, ropivacaine, mepivacaine, chloroprocaine, tetracaine, cocaine, etidocaine, prilocaine, procaine, clonidine, xylazine, medetomidine, dexmedetomidine, VR1 antagonists, and combinations thereof.

10. The composition of claim 8, wherein said pain medication is bupivacaine.

11. The composition of claim 1 further comprising an osteoinductive component.

12. The composition of claim 11 wherein said osteoinductive component is selected from the group consisting of cell attachment mediators, peptide-containing variations of the RGD integrin binding sequence known to affect cellular attachment, biologically active ligands, integrin binding sequence, ligands, bone morphogenic proteins, epidermal growth factor, IGF-I, IGF-II, TGF-β

I-III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, glycoprotein, lipoprotein, bFGF, TGF-β

superfamily factors, BMP-2, BMP-4, BMP-6, BMP-12, BMP-14, sonic hedgehog, GDF6, GDF8, PDGF, tenascin-C, fibronectin, thromboelastin, thrombin-derived peptides, and heparin-binding domains.

13. The composition of claim 1, wherein said biodegradable material component comprises a hydrophilic polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, hyaluronic acid, hyaluronic acid salts, alginates, polyvinylpyrrolidone, polyethylene oxide, polysccarrides, chitins, gelatin, polyacrylic acid, guar gum, and carob bean gum.

14. The composition of claim 1, wherein said biodegradable component comprises about 15 to about 75 weight percent.

15. A method of filling a bone void in a bone, comprising:

providing a bone void filler composition, said void filler comprising a biodegradable material component, an osteoconductive component, and a therapeutically effective amount of a therapeutic agent; and

,

placing said bone void filler into a bone void.

16. The method of claim 15, wherein said biodegradable material component comprises a polymer selected from the group consisting of poly(glycolide), poly(lactide), poly(epsilon-caprolactone), poly(trimethylene carbonate), poly(para-dioxanone),and combinations thereof.

17. The method of claim 15, wherein said biodegradable material component comprises a co-polymer selected from the group consisting of poly(lactide-co-glycolide), poly(epsilon-caprolactone-co-glycolide), poly(glycolide-co-trimethylene carbonate), and combinations thereof.

18. The method of claim 15, wherein said biodegradable material component is selected from the group consisting of albumin, casein, waxes, starch, crosslinked starch, simple sugars, glucose, ficoll, polysucrose, polyvinyl alcohol, gelatine, modified celluloses, carboxymethylcellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl-ethyl cellulose, hydroxypropyl-methyl cellulose, sodium carboxymethyl cellulose, cellulose acetate, sodium alginate, hyaluronic acid, hyaluronic acid derivatives, polyvinyl pyrollidone, polymaleic anhydride esters, polyortho esters, polyethyleneimine, glycols, polyethylene glycol, methoxypolyethylene glycol, ethoxypolyethylene glycol, polyethylene oxide, poly(1,3 bis(p-carboxyphenoxy) propane-co-sebacic anhydride, N,N-diethylaminoacetate, block copolymers of polyoxyethylene and polyoxypropylene, and combinations thereof.

19. The method of claim 18, wherein said biodegradable material component comprises a member selected from the group consisting of hydroxyethyl cellulose, hyaluronic acid, and hyaluronic acid derivatives.

20. The method of claim 15 wherein said osteoconductive component is selected from the group consisting of tricalcium phosphate, alpha-tricalcium phosphate, beta-tricalcium phosphate, calcium carbonate, barium carbonate, calcium sulfate, barium sulfate, hydroxyapatite, a polymorph of calcium phosphate, and combinations thereof.

21. The method of claim 20 wherein said osteoconductive component is beta-tricalcium phosphate.

22. The method of claim 15, wherein said therapeutic agent is selected from the group consisting of pain medication, antiinfectives, analgesics, anti-inflammatory agents, immunosupressives, steroids, including corticosteroids, glycoproteins, lipoproteins, and combinations thereof.

23. The method of claim 22, wherein said pain medication is selected from the group consisting of morphine, nonsteroidal anti-inflammatory drugs, oxycodone, morphine, fentanyl, hydrocodone, naproxyphene, codeine, acetaminophen with codeine, acetaminophen, benzocaine, lidocaine, procaine, bupivacaine, ropivacaine, mepivacaine, chloroprocaine, tetracaine, cocaine, etidocaine, prilocaine, procaine, clonidine, xylazine, medetomidine, dexmedetomidine, VR1 antagonists, and combinations thereof.

24. The method of claim 22, wherein said pain medication is bupivacaine.

25. The method of claim 15, wherein said bone void filler composition further comprises an osteoinductive component.

26. The method of claim 25, wherein said osteoinductive component is selected from the group consisting of cell attachment mediators, peptide-containing variations of the RGD integrin binding sequence known to affect cellular attachment, biologically active ligands, integrin binding sequence, ligands, bone morphogenic proteins, epidermal growth factor, IGF-I, IGF-II, TGF-β

I-III, growth differentiation factor, parathyroid hormone, vascular endothelial growth factor, glycoprotein, lipoprotein, bFGF, TGF-β

superfamily factors, BMP-2, BMP-4, BMP-6, BMP-12, BMP-14, sonic hedgehog, GDF6, GDF8, PDGF, tenascin-C, fibronectin, thromboelastin, thrombin-derived peptides, and heparin-binding domains.

27. The method of claim 15, wherein said biodegradable material component comprises a hydrophilic polymer selected from the group consisting of hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, hyaluronic acid, hyaluronic acid salts, alginates, polyvinylpyrrolidone, polyethylene oxide, polysccarrides, chitins, gelatin, polyacrylic acid, guar gum, and carob bean gum.

28. The method of claim 15, wherein said biodegradable component comprises about 15 to about 75 weight percent.