System and kit for delivering collagen bioglass composite bone grafting materials for regenerating hard tissues
Methods for producing a composite bone graft material that can regenerate bony defects in the body are provided. Also, methods, kits and delivery systems for a minimally invasive delivery of a composition for regenerating bone at or near the site of a bony defect that include, the composition for regenerating bone comprising collagen and bioactive glass are provided.
1. A kit for a minimally invasive delivery of a composition for regenerating bone at or near the site of a bony defect, the kit comprising:
i. at least one tube comprising the composition for regenerating bone comprising about 2-60% collagen and about 40-98% bioactive glass, wherein the composition is free from calcium phosphate, and wherein the tube is capped or sealed when not in use;
ii. a dispensing gun;
iii. an adapter;
iv. a plunger; and
v. optionally, a dispensing tip.
2. The kit of claim 1 , wherein the components of the kit are snap fit into a tray and a retainer is placed to maintain position of the components in the tray.
3. The kit of claim 2 , wherein the tray holds up to four tubes comprising the composition.
4. The kit of claim 1 , further comprising a syringe.
5. The kit of claim 1 , further comprising a “Y” connector, tube connector, or an aspiration needle, or a combination thereof.
6. The kit of claim 1 , wherein the bioactive glass has a porosity of up to 90%.
7. The kit of claim 1 , wherein the bioactive glass has pores ranging from about 1 to about 5100 microns.
8. The kit of claim 1 , wherein the bioactive glass has average pore size of <50 microns.
9. The kit of claim 1 , wherein the bioactive glass has average pore size of 100 microns plus or minus 50 microns.
10. The kit of claim 1 , wherein the bioactive glass has average pore size of 200 microns plus or minus 50 microns.
11. The kit of claim 1 , wherein the bioactive glass has average pore size of 300 microns plus or minus 50 microns.
12. The kit of claim 1 , wherein the bioactive glass has average pore size of 400 microns plus or minus 50 microns.
13. The kit of claim 1 , wherein the bioactive glass has average pore size of 500 microns plus or minus 50 microns.
14. The kit of claim 1 , wherein the bioactive glass has average pore size of 600 microns plus or minus 50 microns.
15. The kit of claim 1 , wherein the bioactive glass has average pore size of 700 microns plus or minus 50 microns.
16. The kit of claim 1 , wherein the composition comprises about 3-60% collagen and about 40-97% bioactive glass.
17. The kit of claim 1 , wherein the composition comprises about 3-50% collagen and about 50-90% bioactive glass.
18. The kit of claim 1 , wherein the composition further comprises an extracellular matrix molecule selected from the group consisting of integrins, fibronectin, vitronectin, osteopontin, bone sialoprotein thrombospondin, and fibrinogen, or a homo or copolymer of glycolides, acrylates, lactic acids, and caprolactone, and a combination thereof.
19. The kit of claim 1 , wherein the composition is un-crosslinked.
20. The kit of claim 1 , wherein the composition is crosslinked.
21. The kit of claim 1 , wherein the composition is freeze-dried.
22. The kit of claim 1 , wherein the bioactive glass have been pre-reacted in water, saline or a buffer.
23. The kit of claim 1 , wherein the bioactive glass is not pre-reacted with a buffer.
24. The kit of claim 1 , wherein the bioactive glass comprises 55-65% 1000-2000 um bioactive glass, 10-20% 90-710 um bioactive glass, and 10-20% 32-125 um bioactive glass.
25. The kit of claim 1 , wherein the bioactive glass comprises 60% 1000-2000 um bioactive glass, 12.5% 90-710 um bioactive glass, and 12.5% 32-125 um bioactive glass.
26. The kit of claim 24 , wherein the 1000-2000 um bioactive glass is porous.
27. The kit of claim 1 , wherein the composition is in a form of a collagen bioactive glass composite.
28. The kit of claim 27 , wherein the collagen bioactive glass composite is lyophilized.
29. The kit of claim 27 , wherein the collagen and bioactive glass composite is lyophilized and crosslinked.
30. The kit of claim 1 , wherein the composition is in a form of a mixture of:
collagen in a granular, particulate, sphere or bead form, or a combination thereof, and
bioactive glass in a granular, particulate, sphere or bead form, or a combination thereof.
31. The kit of claim 1 , wherein the composition is in a granular, particulate, sphere or bead form, or a combination thereof, and comprises collagen and bioactive glass.
32. The kit of claim 1 , wherein the composition further comprises at least one therapeutic agent, a signaling protein, glycosaminoglycan, or a combination thereof.
33. The kit of claim 1 , wherein the bioactive glass is in a granular form, particulate form, matt form, fiber form, hemostatic sponge form, foam form, paste or putty form, or sphere or bead form, or a combination thereof.
34. The kit of claim 1 , wherein the composition is pre-treated with water, saline, blood, bone marrow, a combination thereof, or other biocompatible substance to form a paste.
35. The kit of claim 1 , wherein the bioactive glass comprises silicate based glasses.
36. The kit of claim 1 , wherein the bioactive glass comprises borate based glasses.
37. A method for repairing or regenerating a bony defect comprising
dispensing the composition for regenerating bone comprising about 2-60% collagen and about 40-98% bioactive glass at or near the site of the bony defect using the components of the kit of claim 1 .
38. The method of claim 37 , wherein the composition is moldable upon mixing with saline, blood, bone marrow, or other biocompatible fluid.
39. The method of claim 37 , wherein the composition is pre-treated with water, saline, blood, bone marrow, a combination thereof, or other biocompatible substance to form a paste.
40. The method of claim 37 , wherein the composition is in a form of a collagen bioactive glass composite.
41. The method of claim 40 , wherein the collagen bioactive glass composite is lyophilized.
42. The method of claim 40 , wherein the collagen and bioactive glass composite is lyophilized and crosslinked.
43. The method of claim 37 , wherein the composition is in a form of a mixture of:
collagen in a granular, particulate, sphere or bead form, or a combination thereof, and
bioactive glass in a granular, particulate, sphere or bead form, or a combination thereof.
44. The method of claim 37 , wherein the composition is in a granular, particulate, sphere or bead form, or a combination thereof, and comprises collagen and bioactive glass.