BONE GRAFT

• US 20130260466A1
• Filed: 05/07/2013
• Published: 10/03/2013
• Est. Priority Date: 11/23/2011
• Status: Active Grant

• Current Assignee: BONE Pharm LLC
• Original Assignee: Amendia, Inc. (Spinal Elements, Inc.)
• Inventors: Ganey, Timothy
• Granted Patent: US 9,211,360 B2
• Time in Patent Office: Days
• US Class Current: 435/402
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30838 Microstructures
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: C12N 2525/00 Culture process characterised by gravity, e.g. microgravity
• CPC Class Codes: C12N 5/0662 Stem cells
• CPC Class Codes: C12N 5/0663 Bone marrow mesenchymal stem cells (BM-MSC)
• CPC Class Codes: C12N 5/0664 Dental pulp stem cells, Dental follicle stem cells
• CPC Class Codes: C12N 5/0665 Blood-borne mesenchymal stem cells, e.g. from umbilical cord blood
• CPC Class Codes: C12N 5/0666 Mesenchymal stem cells from hair follicles
• CPC Class Codes: C12N 5/0667 Adipose-derived stem cells [ADSC]; Adipose stromal stem cells
• CPC Class Codes: C12N 5/0668 Mesenchymal stem cells from other natural sources
• CPC Class Codes: E05F 15/42 Detection using safety edges
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1041 : Subsequent to lamination
• CPC Class Codes: Y10T 156/1052 : with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 156/12 : Surface bonding means and/or assembly means with cutting, punching, piercing, severing or tearing

Abstract

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.

Claims

1. A method for producing a sheet material for bone grafts, comprising the steps of

providing a rectangular sheet of suitable biomaterial;

introducing a surface pattern into said suitable biomaterial; and

wherein said surface pattern is enhancing the osteo-conductivity of said biomaterial and is a 3-dimensional substantially continuous network having voids.

2. The method according to claim 1, wherein said sheet has a thickness of about 150 micron or more.

3. The method according to claim 1, wherein said biomaterial is collagen, in particular Type-I collagen.

4. The method according to claim 1, wherein said surface pattern is introduced by etching and/or embossing, and or microprinting the surface or surfaces of the biomaterial.

5. The method according to claim 4, wherein said embossing of the surface or surfaces of the biomaterial is performed by rolling the material in a suitable roller press.

6. The method according to claim 1, wherein said voids have a medium width of about 30-230 microns.

7. The method according to claim 1, further comprising the steps of drying said biomaterial and/or storing of said biomaterial, preferably storing under vacuum.

8. A method for producing a bone matrix scaffold, comprising the steps of

providing at least one sheet material the sheet material having a surface pattern that enhances osteo-conductivity and potentially supports inductivity, wherein the surface pattern is a 3-dimensional substantially continuous network having voids;

cross-linking said at least one sheet material using fibers; and

whereby a macrostructure is formed having a substantially continuous network and voids.

9. The method according to claim 8, wherein at least two sheets of material are cross-linked.

10. The method according to claim 8, wherein a laminate structure consisting of said at least two sheets of material is formed.

11. The method according to claim 8, wherein a semi-solid network, in particular a gel, is formed.

12. The method according to claim 8, wherein said fibers comprise at least one polymer and/or a mixture of polymers.

13. The method according to claim 12, wherein said at least one polymer is a copolymer having carboxylic acid groups and/or amine groups.

14. The method according to claim 12, wherein said at least one polymer is a conductive polymer selected from polypyrrole, polyaniline, polyacetylene, and polythiophene and mixtures thereof.

15. The method according to claim 8, wherein said fibers are collagen fibers.

16. The method according to claim 15, wherein said fibers represent non-aldehyde cross-linked Type I collagen.

17. The method according to claim 15, wherein said collagen is chemically cross-linked, in particular with nordihydroguaiaretic acid.

18. The method according to claim 8, wherein said voids are formed to define openings and the average diameter of said openings and the average diameter of a cross-section of said network is formed to have a ratio of from 2:

1 to 10;

1.

19. The method according to claim 18, wherein said ratio is from 2:

1 to 5;

1.

20. The method according to claim 8, wherein less than 10% of said voids of said macrostructure are formed to have a fractal dimension higher than 1.

21. The method according to claim 8, wherein the exterior surface of said scaffold is made porous.

22. The method according to claim 8, further comprising the step of incubating said macrostructure with cells for a predetermined period of time.

23. The method according to claim 22, 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.

24. The method according to claim 22, wherein the size of said macrostructure changes less than 50% when said cells are added to the matrix.

25. The method according to claim 22 further comprising removing said cells from said macrostructure.