SHAPED LOAD-BEARING OSTEOIMPLANT AND METHODS OF MAKING SAME
A load-bearing osteoimplant which comprises a shaped, coherent aggregate of bone particles.
1 . A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,
wherein the binder is a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide, and
wherein the osteoimplant has a bulk density of greater than about 0.7 g/cm 3 and a wet compressive strength of at least about 3 MPa.
2 . The osteoimplant of claim 1 , wherein the binder is polylactide.
3 . The osteoimplant of claim 1 , wherein the binder is polyglycolide.
4 . The osteoimplant of claim 1 , wherein the binder is polylactide-co-glycolide.
5 . The osteoimplant of claim 1 , wherein the bone particles are selected from the group consisting of nondemineralized bone, substantially fully demineralized bone, partially demineralized bone, superficially demineralized bone, and combinations thereof.
6 . The osteoimplant of claim 5 , wherein the bone particles comprise demineralized bone particles.
7 . The osteoimplant of claim 5 , wherein the bone particle comprise nondemineralized bone particles.
8 . The osteoimplant of claim 5 , wherein the bone particles comprise a combination of demineralized bone particles and nondemineralized bone particles.
9 . The osteoimplant of claim 8 , wherein the weight ratio of demineralized bone particles to nondemineralized bone particles ranges from about 20:1 to about 1:20.
10 . The osteoimplant of claim 1 , wherein the bone particles are in the form of powders, chips, elongate particles, or combinations thereof.
11 . The osteoimplant of claim 1 , wherein the bone particles are allogenic bone particles.
12 . The osteoimplant of claim 1 , wherein the bone particles are autogenous bone particles.
13 . The osteoimplant of claim 1 , wherein the bone particles are xenogenic bone particles.
14 . The osteoimplant of claim 1 further comprising at least one additional component selected from the group consisting of binder, filler, coupling agent, plasticizer, wetting agent, surface active agent, biostatic/biocidal agent, bioactive substance, reinforcing material, reinforcing structure, and combinations thereof.
15 . The osteoimplant of claim 14 further comprises a coupling agent.
16 . The osteoimplant of claim 1 , wherein the osteoimplant is configured as a sheet, plate, dish, cone, pin, screw, tube, tooth, tooth root, bone, bone portion, wedge, wedge portion, cylinder, dowel, interveterbral implant, or suture anchor.
17 . The osteoimplant of claim 1 , wherein the osteoimplant is an interveterbral implant.
18 . The osteoimplant of claim 1 , wherein the osteoimplant is a spinal implant.
19 . The osteoimplant of claim 1 , wherein osteoimplant comprises about 5% to about 95% by weight bone particles.
20 . The osteoimplant of claim 1 , wherein osteoimplant comprises about 20% to about 95% by weight bone particles.
21 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength of at least about 15 MPa.
22 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength of at least about 20 MPa.
23 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength from about 15 MPa to about 130 MPa.
24 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength from about 12 MPa to about 200 MPa.
25 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength from about 17 MPa to about 200 MPa.
26 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength from about 20 MPa to about 200 MPa.
27 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength from about 31 MPa to about 200 MPa.
28 . The osteoimplant of claim 1 , wherein the osteoimplant has a wet compressive strength from about 56 MPa to about 200 MPa.
29 . The osteoimplant of claim 1 , wherein the osteoimplant has a bulk density of greater than about 1.0 g/cm 3 .
30 . A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,
wherein the binder is a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide; and
wherein the osteoimplant has a bulk density of greater than about 0.7 g/cm 3 .
31 . A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,
wherein the binder is a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide; and
wherein the osteoimplant has a wet compressive strength of at least about 3 MPa.
32 . A load-bearing osteoimplant comprising a shaped composition of bone particles and a binder,
wherein the binder is polylactide;
wherein the bone particles are mineralized bone particles, demineralized bone particles, or combinations thereof, and
wherein the osteoimplant has a bulk density of greater than about 0.7 g/cm 3 and a wet compressive strength of at least about 3 MPa.
33 . A method of preparing a load-bearing osteoimplant, the method comprising steps of:
combining bone particles and a polymer selected from the group consisting of polylactide, polyglycolide, and polylactide-co-glycolide; and
applying a compressive force of greater than about 50 psi to the composite to provide an osteoimplant having a bulk density greater than 0.7 g/cm 3 and a wet compressive strength of at least about 3 MPa.
34 . The method of claim 33 , wherein the step of combining comprises combining bone particles and a polymer in the presence of an solvent.
35 . The method of claim 34 , wherein the solvent is ethanol.
36 . The method of claim 33 , wherein the compressive force is greater than about 1,000 psi.
37 . The method of claim 33 , wherein the compressive force is greater than about 2,500 psi.
38 . The method of claim 33 , wherein the compressive force ranges from about 2,500 psi and about 60,000 psi.
39 . The method of claim 33 , wherein the compressive force ranges from about 2,500 psi and about 20,000 psi.
40 . The method of claim 33 , wherein the compressive force is applied for about 0.1 hours to about 180 hours.
41 . The method of claim 33 , wherein the compressive force is applied for about 4 hours to about 72 hours.
42 . The method of claim 33 , wherein the compressive force is applied at a temperature ranging from about 40° C. to about 70° C.
43 . The method of claim 33 , wherein the bone particles are selected from the group consisting of nondemineralized bone, substantially fully demineralized bone, partially demineralized bone, superficially demineralized bone, and combinations thereof.
44 . The method of claim 33 , wherein the bone particles comprise demineralized bone particles.
45 . The method of claim 33 , wherein the bone particle comprise nondemineralized bone particles.
46 . The method of claim 33 , wherein the bone particles comprise a combination of demineralized bone particles and nondemineralized bone particles.
47 . A method of repairing bone, the method comprising steps of:
implanting at a bone repair site a load-bearing osteoimplant of claim 1.