Cortical and cancellous allograft spacer

• US 6,761,739 B2
• Filed: 11/25/2002
• Issued: 07/13/2004
• Est. Priority Date: 11/25/2002
• Status: Active Grant

• Current Assignee: Edison Corporate Center, Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: Shepard, Yolanda Denise
• Primary Examiner(s): Robert, Eduardo C.
• Assistant Examiner(s): Ramana, Anuradha
• Application Number:
  US10/302,895
• Publication Number:
  US 20040102850A1
• Time in Patent Office: 596 Days
• Field of Search: 623/16.11, 623/17.11, 623/17.15, 623/17.16, 623/23.51, 623/23.61, 623/23.75, 606/61
• US Class Current: 623/17.16
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• 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 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30275 tetrahedral, i.e. having a triangular basis
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30808 parallel
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0089 tetrahedral, i.e. having a triangular basis
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof

Abstract

A sterile composite bone graft for use in implants comprising an I beam cortical bone load bearing member upon which is mounted a trapezoidal shaped cancellous member. The allograft cancellous bone member defines tapered side walls, a flat proximal end wall and a flat distal end wall and a channel into the body leading from the front wall to the end wall. The I beam cortical member has a front section with a flat rear surface. A rectangular support bar extends from the flat rear surface to the flat rear wall of the rear section forming a connecting bar which fits into the channel cut into the cancellous member body. The I beam cortical member support bar and the channel of the cancellous member mate together to hold both component members in stable relationship. Pins may be mounted in both members on opposite sides of the members interface.

Claims

1. A sterile composite graft comprising:

a first cancellous bone component member and a second monolithic load bearing component member adapted to be mounted to said first cancellous bone component, said cancellous bone component member defining a front end surface and a rear end surface, an open channel cut into the interior of the cancellous bone component member from said front surface leading to said rear surface, said monolithic load bearing component member having a front portion with a flat rear surface, an integral cross bar member extending outward from said flat rear surface of said front portion to a planar inner surface of a rear portion, said cross bar member being configured to fit into said channel cut into said cancellous bone component member holding said first and second component members together in a mated relationship.

2. A sterile composite graft as claimed in claim 1 wherein said first member is constructed of allograft cancellous bone taken from a group of bones consisting of a cancellous patella, femoral head, long bone condyles and talus.

3. A sterile composite graft as claimed in claim 1 wherein said load bearing component member is cortical bone.

4. A sterile composite graft as claimed in claim 1 wherein said cancellous bone component member has trapezoidal configuration and said load bearing component member front portion has a cross section area which is greater than the cross section area of said load bearing component member rear portion.

5. A sterile composite graft as claimed in claim 1 wherein said cancellous bone component member is a block with a C shaped cross section.

6. A sterile composite graft as claimed in claim 1 wherein said load bearing component member is constructed of ceramic having a compression load over 1000 Newtons.

7. A sterile composite graft as claimed in claim 1 wherein said load bearing component member is constructed of bioabsorbable polymers capable of bearing a compression load over 1000 Newtons.

8. A sterile composite graft as claimed in claim 1 wherein said load bearing component member is constructed of cortical bone which is at least partially demineralized.

9. A sterile composite graft as claimed in claim 1 wherein said cancellous bone component member is constructed of allograft bone which is at least partially demineralized.

10. A sterile composite graft as claimed in claim 1 wherein said load bearing component member front portion and rear portion have top and bottom surfaces which are angled so that planes taken across the same will intersect and said cross bar extending from said front portion engaging said rear portion has a lesser height than said front portion and said rear portion.

11. A sterile composite graft as claimed in claim 1 wherein at least one of said graft component members includes an additive taken from a group of living cells and cell elements consisting of red blood cells, white blood cells, platelets, blood plasma, pluripotential cells, chondrocytes, bone marrow cells, mesenchymal stem cells, osteoblasts, osteoclasts and fibroblasts, epithelial cells and endothelial cells present as a concentration of 10⁵ and 10⁶ per cc of a carrier.

12. A sterile composite graft as claimed claim 1 wherein at least one of said graft components includes an additive taken from a group of growth factors consisting of transforming growth factor (TGF-beta), insulin-like growth factor (IGF-1);

platelet derived growth factor (PDGF), fibroblast growth factor (FGF) (numbers 1-23), osteopontin, vascular endothelial growth factor (VEGF), growth hormones such as somatotropin cellular attractants and attachment agents.

13. A sterile composite graft as claimed claim 1 wherein at least one of said graft component members includes an additive taken from a group consisting of antimicrobial effective against HIV and hepatitis;

antimicrobial and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin, gentamycin and silver salts.

14. A sterile composite graft as claimed in claim 1 including at least one pin mounted in both said cancellous bone component member and said load bearing component member.

15. A sterile composite graft as claimed in claim 1 wherein said component members define bores which are axially aligned when the component members are mated together.

16. A sterile composite graft as claimed in claim 15 wherein at least one of said bores is a blind bore.

17. A sterile composite graft comprising:

a cancellous bone component member and a monolithic load bearing component member matable with said cancellous component member, said cancellous bone component member defining a planar front surface and a planar rear surface with a channel extending between said planar front and rear surfaces into the interior of the cancellous bone component member, said monolithic load bearing component member having a modified I beam construction with a front portion, a cross bar secured to a rear surface of said front portion and a planar inner surface of a rear portion, said cross bar being configured to fit into said channel holding said component members together in a mated relationship.

18. A sterile composite graft as claimed in claim 17 wherein said component members define bores which are axially aligned when the component members are mated together.

19. A sterile composite graft as claimed in claim 18 wherein at least one of said bores is a blind bore.

20. A sterile composite graft as claimed in claim 18 wherein pins are mounted in said axially aligned bores, said pins extending across an intersection between said first cancellous bone component number and said second load bearing component member.

21. A sterile composite graft as claimed in claim 17 wherein said cancellous bone component member has a trapezoidal configuration.

22. A sterile composite graft as claimed in claim 21 wherein said cancellous bone component member has a “

C”

shaped cross section.

23. A sterile composite graft as claimed in claim 17 wherein said load bearing component member rear portion defines a curved outer proximal surface and a planar distal surface and said cross bar is integrally formed with said rear portion and extends away from said rear portion to engage said front portion, said front portion defining a planar proximal surface and a planar distal surface.

24. A sterile composite graft as claimed in claim 23 wherein said rear portion and said front portion have top and bottom planar surfaces, the planes of which form an angle.

25. A sterile composite graft as claimed in claim 24 wherein said angle ranges from 3°

to 5°

.

26. A sterile composite graft as claimed in claim 23 wherein said front portion has rounded edges leading to said distal planar surface.

27. A sterile composite graft as claimed in claim 17 wherein said rear portion and said front portion each form at least one planar surface forming a plane which is angled.

28. A sterile composite graft as claimed in claim 17 wherein said cross bar is rectangularly shaped.

29. A sterile composite graft as claimed in claim 17 wherein said load bearing component member is constructed of allograft cortical bone.

30. A sterile composite graft comprising:

a cancellous bone component member and a monolithic cortical bone component member having spaced front and rear portions which are connected by a support bar, said cancellous bone component member having a trapezoidal shape and a channel cut into the interior of the cancellous bone component member, said cortical bone component member front portion defining a flat rear wall surface which abuts said cancellous bone component member, an integral support bar extending from said flat surface of said front portion to a rear portion defining a flat inner surface which also abuts said cancellous bone component member, said integral support bar being configured to fit into said channel holding said cancellous and cortical bone component members together.

31. A sterile composite graft as claimed in claim 30 wherein at least one of said graft components include an additive taken from a group of living cells and cell elements consisting of red blood cells, white blood cells, platelets, blood plasma, pluripotential cells, chondrocytes, bone marrow cells, mesenchymal stem cells, osteoblasts, osteoclasts and fibroblasts, epithelial cells and endothelial cells present on a concentration of 10⁵ and 10⁶ per cc of a carrier.

32. A sterile composite graft as claimed in claim 30 wherein said component members define bores which are axially aligned when the component members are mated together.

33. A sterile composite graft as claimed in claim 32 wherein at least one of said bores is a blind bore.

34. A sterile composite graft as claimed in claim 30 wherein a pin is mounted in each of said axially aligned bores, said pin extending across an intersection between said first cancellous bone component number and said second load bearing component member.

35. A sterile composite graft as claimed in claim 30 wherein said bone block includes an additive taken from a group consisting of mesenchymal stem cells, natural extracts, tissue transplants, bioadhesives, transforming growth factor (TGF-beta), insulin-like growth factor (IGF-1), platelet derived growth factor fibroblast GF, osteopontin VEGF, blood elements.

36. A sterile composite graft as claimed in claim 30 wherein said cancellous bone component member has a C shaped cross section.

37. A sterile composite bone graft as claimed in claim 30 wherein said cancellous bone component member has side walls tapered at an angle ranging from about 100°

to about 110°

.

38. A sterile composite bone graft as claimed in claim 30 wherein said eortical bone component member has a curved end surface.

39. A sterile composite bone graft as claimed in claim 30 wherein said cortical bone component member has at least one inclined planar surface.

40. A sterile composite bone graft as claimed in claim 39 wherein said inclined planar surface is angled between a range of 3°

to 5°

.

41. A sterile composite bone graft as claimed in claim 30 wherein said support bar has a planar upper surface.

42. A sterile composite graft as claimed in claim 30 wherein said cancellous bone component member has an inclined planar top surface and an inclined planar bottom surface.

43. A sterile composite bone graft as claimed in claim 30 wherein said cortical bone component member has an inclined planar top and bottom surface.

44. A sterile composite bone graft for use in implants comprising:

a monolithic load bearing member constructed of allograft cortical bone having a front portion with a rear planar surface and a rear portion with an inner planar face interconnected by a support bar extending between said planar surfaces to connect said front and rear portions, an allograft cancellous member defining inwardly tapered side walls, a flat proximal end surface and a flat distal end surface and an open channel cut into said cancellous member extending from said proximal end surface to said distal end surface configured to receive said support bar, said monolithic load bearing member and cancellous member being mated together with said support bar being mounted in said cancellous member channel, said front portion and rear portion of said cortical bone member having a height which is at least equal to a height of said cancellous member when the same is mated to said cortical member with the rear portion of said load bearing member having a smaller cross sectional area than the front portion.

45. A sterile composite graft as claimed in claim 44 wherein said load bearing and cancellous members define bores which are axially aligned when the members are mated together, said cancellous member defining at least one blind bore and pin means mounted in said axially aligned bores, said pin means extending across an intersection between said cancellous bone member and said load bearing member.

46. A sterile composite bone graft as claimed in claim 44 wherein said side walls are tapered at an angle ranging from about 100°

to about 110°

.

47. A sterile composite bone graft as claimed in claim 44 wherein at least one of said members includes an additive taken from a group consisting of living cells, cell elements, red blood cells, white blood cells, platelets, blood plasma, pluripotential cells, chondrocytes, bone marrow cells, mesenchymal stem cells, osteoblasts, osteoclasts and fibroblasts, epithelial cells and endothelial cells present on a concentration of 10⁵ and 10⁶ per cc of a carrier.

48. A sterile composite graft as claimed in claim 44 wherein at least one of said members includes an additive consisting of natural extracts, tissue transplants, bioadhesives, transforming growth factor (TGF-beta), insulin-like growth factor (IGF-1), platelet derived growth factor, fibroblast GF, osteopontin VEGF, blood elements.

49. A sterile composite graft as claimed in claim 44 wherein said rear portion and said front portion of said loading bearing member have top and bottom planar surfaces, the planes of which form an angle.

50. A sterile composite graft as claimed in claim 44 wherein said side walls are tapered at an angle ranging from 3°

to 5°

.

51. A sterile composite graft as claimed in claim 44 wherein said rear portion and said front portion of said load bearing member form at least one planar surface forming a plane which is angled with respect to a longitudinal central axis drawn through said load bearing member.

52. A sterile composite graft comprising:

a cancellous bone component member and a monolithic cortical bone component member with an I-beam configuration, said cancellous bone component member having a trapezoidal shape and a channel cut into the interior of the cancellous bone component, said monolithic cortical bone component member defining a flat inner surface which abuts said cancellous bone component member, a connected support bar extending from said flat surface to a rear section defining a flat inner surface which also abuts said cancellous bone component member, said support bar being configured to fit into said channel holding said cancellous and cortical bone component members together.

53. A sterile composite bone graft for use in implants comprising:

a monolithic load bearing member with an I-beam configuration constructed of allograft cortical bone defining a front portion with a rear planar surface, a support bar extending from said rear planar surface to connect with a planar inner surface of a rear portion, an allograft cancellous member defining inwardly tapered side walls, a flat proximal end surface and a flat distal end surface and a channel cut into said cancellous member extending from said proximal end surface to said distal end surface, said load bearing member and cancellous member being mated together with said support bar being mounted in said cancellous member channel, said front portion and rear portion of said load bearing member having a height which is at least equal to a height of said cancellous member when the cancellous member is mated to said load bearing member.