Bone graft

• US 9,211,360 B2
• Filed: 05/07/2013
• Issued: 12/15/2015
• Est. Priority Date: 11/23/2011
• Status: Active Grant

• Current Assignee: BONE Pharm LLC
• Original Assignee: Vivex Biomedical, Inc. (Vivex Biologic, Inc.)
• Inventors: Ganey, Timothy
• Primary Examiner(s): Gebreyesus, Kagnew H
• Assistant Examiner(s): Nguyen, Nghi
• Application Number:
  US13/888,640
• Publication Number:
  US 20130260466A1
• Time in Patent Office: 952 Days
• Field of Search: 623/23.55, 623/116.11, 623/23.72, 623/23.73, 623/23.74, 623/23.75, 623/23.76, 623/23.61
• US Class Current: 1/1
• 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

A method for producing a bone matrix scaffold has the steps of providing at least one sheet material and cross-linking the at least one sheet material using fibers. The sheet material has a surface pattern that enhances osteo-conductivity and potentially supports inductivity. The surface pattern is a 3-dimensional substantially continuous network having voids. The combination of the at least one sheet and fibers form a macrostructure having substantially continuous network and voids.

Claims

1. 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, the surface pattern mimics an under-modelled marine mammal having a greater trabecular thickness and spacing and a lower connectivity and trabecular number for equalized total volume compared to adult human bone morphology, the trabecular morphology exhibiting;

2. The method according to claim 1, wherein at least two sheets of material are cross-linked, each sheet having the surface pattern, wherein the surface pattern mimics whale bone morphology having the defined trabecular morphology.

3. The method according to claim 2, wherein a laminate structure consisting of said at least two sheets of material is formed.

4. The method according to claim 1, wherein a semi-solid network, a gel, is formed.

5. The method according to claim 1, wherein said fibers comprise at least one polymer and/or a mixture of polymers.

6. The method according to claim 5, wherein said at least one polymer is a copolymer having carboxylic acid groups and/or amine groups.

7. The method according to claim 5, wherein said at least one polymer is a conductive polymer selected from polypyrrole, polyaniline, polyacetylene, and polythiophene and mixtures thereof.

8. The method according to claim 1, wherein said fibers are collagen fibers.

9. The method according to claim 8, wherein said fibers represent non-aldehyde cross-linked Type I collagen.

10. The method according to claim 8, wherein said collagen is chemically cross-linked with nordihydroguaiaretic acid.

11. The method according to claim 1, 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.

12. The method according to claim 11, wherein said ratio is from 2:

1 to 5;

1.

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

14. The method according to claim 1, wherein the exterior surface of said scaffold is made porous.

15. The method according to claim 1, further comprising the step of incubating said macrostructure with cells for a predetermined period of time.

16. The method according to claim 15, wherein said cells are selected from the group of living cells and recombinant cells, chondrocytes, and growth factor producing cells.

17. The method according to claim 15, wherein the size of said macrostructure changes less than 50% when said cells are added to the matrix.

18. The method according to claim 15 further comprising removing said cells from said macrostructure.