Implantable bone graft

• US 20040193270A1
• Filed: 03/31/2003
• Published: 09/30/2004
• Est. Priority Date: 03/31/2003
• Status: Abandoned Application

• Current Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Original Assignee: Depuyacromed Incorporated
• Inventors: DiMauro, Thomas M., Serhan, Hassan
• Application Number:
  US10/405,062
• Publication Number:
  US 20040193270A1
• Time in Patent Office: Days
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• 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 2002/30599 stackable
• CPC Class Codes: A61F 2002/30879 Ribs
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/445 Intervertebral disc tissue harvest sites
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0082 parallelepipedal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2310/00203 containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00592 Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3834 : Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/3856 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/3895 : using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges

Abstract

An intervertebral fusion device, a method of making the intervertebral fusion device, and a method of using the intervertebral fusion device to promote fusion between two consecutive vertebrae in a patient is described. The intervertebral fusion device has an intervertebral fusion cage that has a load bearing wall, and a porous matrix adjacent to the load bearing wall. The load bearing wall of the fusion cage has a greater density than the internal porous matrix. The open pores of the porous matrix define an inner surface to which one or more agents that promote bone growth are attached.

Claims

1. An intervertebral fusion device, comprising:

a) an intervertebral fusion cage, comprising;

i) a load bearing wall; and

ii) a porous matrix mechanically attached to the load bearing wall, wherein the open pores of the porous matrix define an inner surface; and

b) one or more agents that promote bone growth attached to the inner surface, wherein the agent is about 5 times to about 30 times more concentrated than the concentration found in bone marrow aspirate or platelet rich plasma.

2. The device of claim 1, wherein one or more of the agents that promote bone growth are a progenitor cells.

3. The device of claim 2, wherein the progenitor cells are concentrated by passing a solution of platelet rich plasma or bone marrow aspirate suspension through the porous matrix one or more times.

4. The device of claim 2, wherein the progenitor cells are selected from the group consisting of mesenchymal stem cells, hematopoietic cells, embryonic stem cells and combinations thereof.

5. The device of claim 1, further comprising a growth factor.

6. The device of claim 5, wherein the growth factor is concentrated by passing a solution comprising a recombinant growth factor through the porous matrix one or more times.

7. The device of claim 5, wherein the growth factor is concentrated by passing a solution of platelet rich plasma or bone marrow aspirate suspension through the porous matrix one or more times.

8. The device of claim 5, wherein the growth factor is selected from the group consisting of bone morphogenic protein or a precursor thereof, isoforms of platelet derived growth factors, fibroblast growth factors, epithelial growth factors, isoforms of transforming growth factor Beta, insulin-like growth factors, and combinations thereof.

9. The device of claim 8, wherein the growth factor is bone morphogenic protein or a precursor thereof.

10. The device of claim 1, wherein the fusion cage comprises a ceramic.

11. The device of claim 10, wherein the ceramic is an oxide of alumina, zirconia or a combination thereof.

12. The device of claim 11, wherein the ceramic comprises hydroxyapatite, tricalcium phosphate, or a combination thereof.

13. The device of claim 1, wherein the fusion cage comprises a biopolymer.

14. The device of claim 13, wherein the biopolymer is selected from the group consisting of polylactic acid, polyglycolic acid, a copolymer of polylactic acid and polyglycolic acid, a polyarylethyl ketone, polygalactic acid, polycaprolactone, polyethylene oxide, polypropylene oxide, polysulfone, polyethylene, polypropylene, a polyaryletherketone, and combinations thereof.

15. The device of claim 14, wherein the fusion cage comprises a polyaryletherketone selected from the group consisting of polyetheretherketone, poly(arylether ketone ketone), polyetherketone, and combinations thereof.

16. The device of claim 15, wherein the fusion cage further comprises carbon fibers.

17. The device of claim 16, wherein the composition of the fusion cage is between about 40% and about 60% polyarylether ketone.

18. The device of claim 16, wherein the composition of the fusion cage is between about 1% and about 60% carbon fiber.

19. The device of claim 1, wherein the porous matrix is integrally bound to the load bearing wall.

20. The device of claim 1, wherein the porous matrix has a porous volume of between about 40% and about 80%.

21. The device of claim 1, wherein the porous matrix has an average pore diameter of between about 25 μ

m and about 1000 μ

m.

22. The device of claim 1, wherein the load bearing wall has an upper and lower bearing surfaces that have teeth.

23. The device of claim 1, wherein the fusion cage is tapered in the anterior to posterior direction to achieve lordosis.

24. The device of claim 1, wherein the fusion cage is tapered in the posterior to anterior direction to achieve kyphosis.

25. The device of claim 1, comprising more than one fusion cage stacked on top of each other.

26. An intervertebral fusion device, comprising:

a) an intervertebral fusion cage, comprising;

i) a load bearing wall; and

ii) a porous matrix mechanically attached to the load bearing wall, wherein the open pores of the porous matrix define an inner surface; and

b) one or more agents that promote bone growth attached to the inner surface, wherein at least one agent is a concentrated growth factor.

27. A method of fabricating an intervertebral fusion device, comprising the steps of:

a) providing an intervertebral fusion cage, comprising;

i) a load bearing wall; and

ii) a porous matrix mechanically attached to the load bearing wall, wherein the open pores of the porous matrix define an inner surface; and

b) passing a solution comprising one or more agents that promote bone growth through the porous matrix, thereby attaching the agent to the inner surface.

28. The method of claim 27, wherein the solution comprises progenitor cells.

29. The method of claim 28, wherein the progenitor cells are selected from the group consisting of mesenchymal stem cells, hematopoietc cells, embryonic stem cells, and combinations thereof.

30. The method of claim 28, wherein the solution is platelet rich plasma or bone marrow aspirate suspension.

31. The method of claim 27, wherein the solution comprises a growth factor.

32. The method of claim 31, wherein the growth factor is selected from the group consisting of bone morphogenic protein or a precursor thereof, isoforms of platelet derived growth factors, fibroblast growth factors, epithelial growth factors, isoforms of transforming growth factor Beta, insulin-like growth factors, and combinations thereof.

33. The method of claim 32, wherein the growth factor is bone morphogenic protein or a precursor thereof.

34. The method of claim 31, wherein the solution comprises a recombinant growth factor.

35. The method of claim 31, wherein the solution is platelet rich plasma or bone marrow aspirate suspension.

36. A intervertebral fusion device fabricated using the method of claim 27.

37. A method of promoting fusion of two consecutive vertebrae in a mammal, comprising the steps of:

a) providing an intervertebral fusion cage, comprising;

i) a load bearing wall; and

ii) a porous matrix mechanically attached to the load bearing wall, wherein the open pores of the porous matrix define an inner surface; and

b) passing a solution comprising one or more agents that promote bone growth through the porous matrix, thereby attaching the agent to the inner surface; and

c) inserting the fusion cage containing the agent into the intervertebral space between the two vertebrae.

38. The method of claim 37, wherein the solution comprises progenitor cells.

39. The method of claim 38, wherein the progenitor cells are selected from the group consisting of mesenchymal stem cells, hematopoietc cells, embryonic stem cells, and combinations thereof.

40. The method of claim 38, wherein the solution is platelet rich plasma or bone marrow aspirate suspension.

41. The method of claim 40, wherein the solution is an autologous solution.

42. The method of claim 41, wherein the solution is passed through the porous matrix during a surgical procedure to insert the fusion cage.

43. The method of claim 37, wherein the solution comprises a growth factor.

44. The method of claim 43, wherein the growth factor is selected from the group consisting of bone morphogenic protein or a precursor thereof, isoforms of platelet derived growth factors, fibroblast growth factors, epithelial growth factors, isoforms of transforming growth factor Beta, insulin-like growth factors, and combinations thereof.

45. The method of claim 44, wherein the growth factor is bone morphogenic protein or a precursor thereof.

46. The method of claim 43, wherein the solution comprises a recombinant growth factor.

47. The method of claim 44, wherein the solution is platelet rich plasma or bone marrow aspirate suspension.

48. The method of claim 47, wherein the solution is an autologous solution.

49. The method of claim 48, wherein the solution is passed through the porous matrix during a surgical procedure to insert the fusion cage.

50. The method of claim 37, wherein the fusion cage is inserted from the anterior side of the mammal.

51. The method of claim 37, wherein the fusion cage is inserted from the posterior side of the mammal.