Device and process for producing fiber products and fiber products produced thereby
The present invention is directed to a fiber, preferably bone fiber, having a textured surface, which acts as an effective binding substrate for bone-forming cells and for the induction or promotion of new bone growth by bone-forming cells, which bind to the fiber. Methods of using the bone fibers to induce or promote new bone growth and bone material compositions comprising the bone fibers are also described. The invention further relates to a substrate cutter device and cutter, which are effective in producing substrate fibers, such as bone fibers.
1. A frozen allogeneic bone material composition stored in a sterile container for implantation in a human patient, comprising:
(a) human demineralized cortical bone,
(b) human non-demineralized bone comprising cortical bone, cancellous bone, or a combination thereof,
(c) osteocytes, and
(d) a biological fluid, wherein the biological fluid is a biological fluid selected from the group consisting of plasma, bone marrow, blood, a blood product and a combination thereof,
wherein the allogeneic bone material composition is frozen and stored in the sterile container.
2. The allogeneic bone material composition of claim 1 , wherein the composition further comprises pre-osteoblasts.
3. The allogeneic bone material composition of claim 1 , wherein the composition further comprises osteoblasts.
4. The allogeneic bone material composition of claim 1 , wherein the composition further comprises cells selected from the group consisting of stem cells, connective tissue progenitor cells, and combinations thereof.
5. The allogeneic bone material composition of claim 1 , wherein the composition further comprises stem cells.
6. The allogeneic bone material composition of claim 1 , wherein the osteocytes are suitable for forming an osteoid.
7. The allogeneic bone material composition of claim 1 , wherein the demineralized cortical bone is in the form of particles.
8. The allogeneic bone material composition of claim 1 , wherein the demineralized cortical bone is in the form of fibers.
9. The allogeneic bone material composition of claim 8 , wherein the bone fibers have a length and thickness, and wherein the fiber length is greater than 10 to 200 times the fiber thickness.
10. The allogeneic bone material composition of claim 8 , wherein the bone fibers have a length and thickness, and wherein the fiber length is greater than 40 to 100 times the fiber thickness.
11. The allogeneic bone material composition of claim 8 , wherein the bone fibers have a length, and wherein the average fiber length is from 1 mm to 100 mm.
12. The allogeneic bone material composition of claim 8 , wherein the bone fibers have a length, and wherein the average fiber length is from 20 mm to 30 mm.
13. The allogeneic bone material composition of claim 1 , wherein the demineralized cortical bone contains calcium at a level of from 0.1 wt % to 7.7 wt %.
14. The allogeneic bone material composition of claim 1 , wherein the demineralized cortical bone contains calcium at a level of from 1 wt % to 4 wt %.
15. The allogeneic bone material composition of claim 1 , wherein the non-demineralized bone comprises cortical bone.
16. The allogeneic bone material composition of claim 1 , the non-demineralized bone comprises cancellous bone.
17. The allogeneic bone material composition of claim 1 , the non-demineralized bone is in the form of chunks.
18. The allogeneic bone material composition of claim 1 , the non-demineralized bone is in the form of particles.
19. The allogeneic bone material composition of claim 1 , further comprising a bone growth agent.
20. The allogeneic bone material composition of claim 19 , wherein the bone growth agent is selected from the group consisting of bone morphogenic proteins, angiogenic factors, growth and differentiation factors, mitogenic factors, osteogenic factors, chondrogenic factors and combinations thereof.