The present invention relates to a novel bone graft and methods for producing said graft. Said bone graft can be used for surgical, plastic and/or cosmetic bone replacement for a patient in need thereof. The bone graft is made of a scaffold or matrix of sheet material having a 3-dimensional pattern of a continuous network of voids and/or indentations for enhancing new bone growth.
1. A sheet material for a bone matrix scaffold, comprising a surface pattern that is enhancing osteo-conductivity, wherein the surface pattern is a 3-dimensional continuous network having voids or indentations, the surface pattern mimicking under-modeled cancellous bone of a marine or sea mammal; and wherein the bone pattern exhibits the following characteristics;
BIOPSY
BV/TV
BS/BV
TbTh
TbSp
TbN
Ost#
Cross
17.71
14.98
135.16
631.70
1.33
230/mm 2
Long
24.64
8.67
231.05
710.09
1.06
150/mm 2 .
2. The sheet material according to claim 1 , wherein the sheet has a thickness of 150 microns to 2 mm.
3. The sheet material according to claim 1 , wherein the sheet consists essentially of collagen.
4. The sheet material according to claim 1 , wherein the voids have an average width in the range of 30 to 150 microns.
5. The sheet material according to claim 1 , wherein said material is essentially biodegradable, bioerodable and/or bioresorbable, and/or bioinstructive.
6. The bone matrix scaffold according to claim 1 , wherein the sheet material forms a macrostructure having a substantially continuous network and voids.
7. The bone matrix scaffold according to claim 6 , further comprising at least one or more additional sheets of material having the surface pattern mimicking under-modeled cancellous bone of a marine or sea mammal; and wherein the bone pattern exhibits the following characteristics;
BIOPSY
BV/TV
BS/BV
TbTh
TbSp
TbN
Ost#
Cross
17.71
14.98
135.16
631.70
1.33
230/mm 2
Long
24.64
8.67
231.05
710.09
1.06
150/mm 2 .
8. The bone matrix scaffold according to claim 7 , comprising a laminate structure consisting of the at least one or more additional sheets of material and the sheet forming the macrostructure.
9. The bone matrix scaffold according to claim 6 , wherein said network is semi-solid, in particular forming a gel.
10. The bone matrix scaffold according to claim 6 , furthermore comprising crosslink-structures.
11. The bone matrix scaffold according to claim 10 , wherein said crosslink-structures comprise at least one polymer and/or a mixture of polymers.
12. The bone matrix scaffold according to claim 11 , wherein said at least one polymer is a copolymer having carboxylic acid groups and/or amine groups.
13. The bone matrix scaffold according to claim 11 , wherein said at least one polymer is a conductive polymer selected from polypyrrole, polyaniline, polyacetylene, and/or polythiophene.
14. The bone matrix scaffold according to claim 11 , wherein said crosslink-structures comprise collagen fibers.
15. The bone matrix scaffold according to claim 14 , wherein said crosslink-structures comprise non-aldehyde cross-linked type I collagen.
16. The bone matrix scaffold according to claim 14 , wherein said crosslink-structures form spokes and/or mimic cell microfilaments.
17. The bone matrix scaffold according to claim 14 , wherein said collagen is chemically cross-linked with nordihydroguaiaretic acid to confer stability.
18. The bone matrix scaffold according to claim 6 having a surface area of at least 1 m 2 /g.
19. The bone matrix scaffold according to claim 6 , wherein the voids of said sheet forming the macrostructure are continuous.
20. The bone matrix scaffold according to claim 8 , wherein at least 10% of said voids of said sheet forming the macrostructure and said voids of said one or more additional sheets of material are connected.
21. The bone matrix scaffold according to claim 6 , wherein said voids of said sheet forming said macrostructure and said voids of said additional sheets of material are not connected.
22. The bone matrix scaffold according to claim 6 , wherein said voids at the surface of said macrostructure define openings and the average diameter of said openings measured at the surface and the average diameter of the voids measured in a cross-section of the network of the macrostructure have a ratio of from 2:1 to 10:1.
23. The bone matrix scaffold according to claim 22 , wherein the ratio is from 2:1 to 5:1.
24. The bone matrix scaffold according to claim 6 , wherein the network of a cubic portion of said matrix has dimensions of 0.5 cm on all sides and voids defining openings with an average diameter of 50-800 μm, and at least 10% of the voids are connected.
25. The bone matrix scaffold according to claim 24 , wherein at least 20% of the voids are connected.
26. The bone matrix scaffold according to claim 6 , wherein a cross section of said network has a maximum and minimum diameter, with a ratio of the maximum and minimum diameter of from 1:1 to 10:1.
27. The bone matrix scaffold according to claim 6 , wherein the exterior surface of said scaffold is porous.
28. The bone matrix scaffold according to claim 27 , having a porosity of at least 20%.
29. The bone matrix scaffold according to claim 6 , wherein said bone matrix scaffold is essentially biodegradable, bioerodable and/or bioresorbable.
30. The bone matrix scaffold according to claim 6 , wherein the bone matrix scaffold is essentially permeable to body fluids and/or cells.
31. The bone matrix scaffold according to claim 6 , further comprising cells and/or proteins.
32. The bone matrix scaffold according to claim 31 , wherein said cells are selected from the group of living cells and recombinant cells, chondrocytes, growth factor producing cells, such as TGF-producing cells, and osteoblasts, and the proteins are selected from proteins that inhibit or enhance vascularization, enhance or retard innervation, attune or suppress inflammation accuate or impede cell proliferation.
33. The bone matrix scaffold according to claim 31 , wherein the size of said matrix scaffold changes less than 50% when said cells are added to the matrix.
34. The bone matrix scaffold according to claim 6 having a compressive modulus of at least 0.4 MPa at 4% strain.
35. The bone matrix scaffold according to claim 6 having a density of less than 0.150 g/cm 3 .