Multi-phase osteochondral implantable device
An osteochondral implantable device is provided, comprising an upper cap and at least one insert comprising a non-polymeric material in physical contact with the upper cap, said lower insert comprising at least one non-polymeric material, wherein the porosity of the upper cap is greater than the porosity of the insert and the Young's modulus of the upper cap is smaller than the Young's modulus of the insert.
1. An osteochondral implantable device comprising:
an upper cap comprising a synthetic biodegradable polymer; and
at least one insert in contact with the upper cap, said at least one insert comprising at least one non-polymeric material comprising a ceramic comprising between about 12% and about 50% hydroxyapatite and between about 50% and about 88% tri-calcium phosphate.
2. The osteochondral implantable device of claim 1 , wherein the synthetic biodegradable polymer comprises polylactic acid, polyglycolic acid, polylacticpolyglycolic acid, polyorthoesters, Polycapralactone, Polydiaxonone, Polyvynal Fumarate, or any combination thereof.
3. The osteochondral implantable device of claim 1 , wherein the upper cap comprises a co-polymer of lactic and glycolic acids.
4. The osteochondral implantable device of claim 1 , wherein the at least one insert further comprises bone.
5. The osteochondral implantable device of claim 4 , wherein the bone is an allograft bone.
6. The osteochondral implantable device of claim 1 , wherein the ceramic comprises calcium phosphate dibasic, calcium sulfate, calcium carbonate, or any combination thereof.
7. The osteochondral implantable device of claim 1 , wherein the ceramic comprises about 30% hydroxyapatite and about 70% tri-calcium phosphate.
8. The osteochondral implantable device of claim 1 , wherein the ceramic comprises about 15% hydroxyapatite and about 85% tri-calcium phosphate.
9. The osteochondral implantable device of claim 1 , wherein the upper cap comprises at least one collar portion to receive at least a portion of the at least one insert.
10. The osteochondral implantable device of claim 9 , wherein the at least one collar portion comprises at least one window.
11. The osteochondral implantable device of claim 10 , wherein the at least one insert comprises at least one protrusion such that the at least one protrusion of the at least one insert fits into the at least one window of the at least one collar portion when the osteochondral implantable device is assembled.
12. The osteochondral implantable device of claim 9 , wherein the at least one collar portion of the upper cap is shaped to secure the at least one insert.
13. The osteochondral implantable device of claim 12 , wherein the at least one collar portion of the upper cap is shaped to secure the at least one insert by a bayonet-type lock.
14. The osteochondral implantable device of claim 1 further comprising at least one bioactive agent.
15. The osteochondral implantable device of claim 14 wherein the at least one bioactive agent is selected from the group consisting of osteogenic agents, chondrogenic agents, antibiotics, anti-inflammatory agents, pain-reducing agents, anti-catabolic agent, anabolic agent, analgesic agent and any combination thereof.
16. The osteochondral implantable device of claim 14 wherein the at least one bioactive agent is included within the at least one upper cap.
17. The osteochondral implantable device of claim 14 wherein the at least one bioactive agent is included within the at least one insert.
18. The osteochondral implantable device of claim 14 wherein the at least one bioactive agent is BMP-2.
19. The osteochondral implantable device of claim 1 , wherein the upper cap has a predetermined shape.
20. The osteochondral implantable device of claim 1 further comprising a non-porous film covering at least a portion of the upper cap, wherein said at least the portion is exposed to synovial fluid when the osteochondral implantable device is placed into a tissue defect.
21. The osteochondral implantable device of claim 1 , wherein at least one of the upper cap and the at least one insert comprises at least one reservoir.
22. The osteochondral implantable device of claim 21 , wherein the at least one reservoir contains at least one bioactive agent.
23. The osteochondral implantable device of claim 22 , wherein the at least one bioactive agent is in a sustained-release form.
24. The osteochondral implantable device of claim 1 , with the proviso that the osteochondral implantable device does not include a fixation device which is embedded within the osteochondral implantable device and insertable into a tissue receptacle.
25. The osteochondral implantable device of claim 1 , wherein a porosity of the upper cap is greater than a porosity of the at least one insert, and a Young's modulus of the upper cap is smaller than a Young's modulus of the at least one insert.
26. The osteochondral implantable device of claim 1 , wherein the upper cap comprises a surfactant comprising metal soaps of fatty acids, alkyl aryl sulfonic acids, linear aklylbenzene sulfonates, alky sulfates, alcohol ethoxylates, alcohol ethoxy sulfates, alkylphenol ethoxylates, alpha olefin sulfonates, secondary alkane sulfonates, or alpha olefin sulfonates.
27. A kit comprising:
an upper cap comprising a synthetic biodegradable polymer; and
at least one insert comprising at least one non-polymeric material comprising a ceramic comprising between about 12% and about 50% hydroxyapatite and between about 50% and about 88% tri-calcium phosphate.
28. The kit of claim 27 further comprising a set of instructions.
29. The kit of claim 27 further comprising at least one bioactive agent.
30. The kit of claim 29 , wherein the at least one bioactive agent is BMP.
31. The kit of claim 27 , further comprising a bioadhesive capable of securing the upper cap and the at least one insert in a fixed attachment.
32. The kit of claim 27 , wherein a porosity of the upper cap is greater than a porosity of the at least one insert, and a Young's modulus of the upper cap is smaller than a Young's modulus of the at least one insert.
33. The osteochondral implantable device of claim 1 , wherein the upper cap comprises a non-toxic anionic surfactant, a cationic surfactant, an amphoretic surfactant, or a nonionic surfactant.
34. The osteochondral implantable device of claim 33 , wherein the non-toxic anionic surfactant, the cationic surfactant, the amphoretic surfactant, and the nonionic surfactant are compatible with the upper cap and/or the at least one insert.