Bone-tendon-bone assembly with cancellous allograft bone block

• US 6,730,124 B2
• Filed: 10/23/2002
• Issued: 05/04/2004
• Est. Priority Date: 03/08/2002
• Status: Active Grant

• Current Assignee: Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: Steiner, Anton J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US10/277,838
• Publication Number:
  US 20030171810A1
• Time in Patent Office: 559 Days
• Field of Search: 623/13.11, 623/13.12, 623/13-3-, 623/17.11, 623/17.16
• US Class Current: 623/13.14
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2002/0852 Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/087 Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• 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 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30228 Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30881 Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30891 Plurality of protrusions
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30894 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61L 2430/10 : for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 : Bones
• CPC Class Codes: A61L 27/3662 : Ligaments, tendons
• CPC Class Codes: A61L 27/3691 : characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3695 : characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61L 27/3804 : characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3847 : Bones
• CPC Class Codes: A61L 27/386 : Ligaments, tendons

Abstract

The invention is directed toward a cancellous bone block assembly with at least one tendon replacement member being extended between two shaped cancellous bone blocks. Each substantially cylindrically shaped cancellous bone block has a central through going bore, a flat exterior longitudinal surface and a channel longitudinally cut in the exterior of the bone block body opposite the flat longitudinal surface. The tendon replacement member is inserted through the central through going bore around the end of the block and looped back along the flat longitudinal side where it is tied to the back of the tendon loop. A channel cut in the exterior surface is adapted to receive an interference screw to keep the block anchored in a bone tunnel previously cut in the respective bone.

Claims

1. A sterile composite graft comprising:

first and second bone blocks, each bone block defining a central through going bore having a cross section which will allow a ligament replacement to be passed therethrough and at least one longitudinal channel cut substantially parallel to the axis of the central through going bore in the exterior surface of said bone block with the opposite side of the bone block defining a flat longitudinal surface, a ligament replacement mounted to said bone blocks, said ligament replacement extending through said central bore of said bone blocks and looped around said first and second bone blocks adjacent to said longitudinal flat surface.

2. A sterile composite graft as claimed in claim 1 wherein said ligament replacement comprises at least one tendon taken from a group of tendons consisting of a semitendinous tendon, a patellar tendon, gracilis tendon, quadriceps tendon, adductor magnus tendon, peroneus tendons, tibialis tendons and hallucis Achilles tendon.

3. A sterile composite graft as claimed in claim 1 wherein said first and second bone blocks define a central through going bore with a substantially oval cross section and further includes at least one suture hole drilled radially through each of said bone blocks spaced away from the longitudinal channel through to the central bore.

4. A sterile composite graft as claimed in claim 1 wherein said first and second bone blocks are constructed of allograft cancellous bone.

5. A sterile composite graft as claimed in claim 4 wherein said first and second bone block constructed of allograft cancellous bone are taken from a group of bones consisting of a cancellous patella, femoral head, long bone condyles and talus.

6. A sterile composite graft as claimed in claim 1 wherein said first and second bone blocks are constructed of xenograft cancellous bone.

7. A sterile composite graft as claimed in claim 1 wherein said first and second bone blocks are constructed of ceramic.

8. A sterile composite graft as claimed in claim 1 wherein said first and second bone blocks are constructed of bioabsorbable polymers.

9. A sterile composite graft as claimed in claim 1 wherein said ligament replacement comprises a semitendinosus tendon.

10. A sterile composite graft as claimed in claim 1 wherein said ligament replacement comprises a patellar tendon.

11. A sterile composite graft as claimed in claim 1 wherein said ligament replacement comprises a gracilis tendon.

12. A sterile composite graft as claimed in claim 1 wherein at least one bone block includes an additive selected from a group consisting of living cells, cell elements, chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, fibroblasts, epithelial cells and entothial cells, natural extracts, tissue transplants, and growth factors including transforming growth factor (TGF-beta), insulin growth factor (IGF-1), platelet derived growth factor (PDGF), fibroblast growth factor (FGF)(Numbers 1-23), vascular endothelial growth factor (VEGF), osteopontin;

growth hormone including somatotropin;

cellular attractants and attachment agents;

fibronectin;

immuno-suppressants;

permeation enhancers, e.g. fatty acid esters including laureate, myristate and stearate monoesters of polyethylene glycol, enamine derivatives, alpha-keto aldehydes.

13. A sterile composite graft as claimed in claim 1 wherein at least one of said first and second bone blocks is constructed of allograft bone.

14. A sterile composite graft as claimed in claim 1 wherein at least one of said first and second bone blocks is constructed of allograft cancellous bone.

15. A sterile composite graft as claimed in claim 1 wherein at least one of said first and second bone blocks is constructed of ceramic.

16. A sterile composite graft as claimed in claim 1 wherein at least one of said first and second bone blocks is constructed of xenograft cancellous bone.

17. A sterile composite graft as claimed in claim 1 wherein at least one of said first and second bone blocks is constructed of bioabsorbable polymers.

18. A sterile composite graft as claimed in claim 1 wherein at least one bone block includes an additive selected from a group consisting of living cells, cell elements, growth factors, growth hormones, cellular attractants and attachment agents;

fibronectin;

immuno-suppressants, and permeation enhancers.

19. A sterile composite graft as claimed in claim 1 wherein said ligament replacement comprises a plurality of tendons.

20. A sterile bone-tendon-bone assembly comprising:

an allograft cancellous bone block defining an outer curved surface, a central through going bore with a substantially oval cross section and a channel cut in its outer exterior surface;

the exterior of said bone block opposite said channel being formed with a planar surface, a tendon replacement member comprising an allograft bone block and an integral tendon, said tendon extending through said central bore of said bone block and looped around said planar surface of said bone block and at least one suture hole cut transverse to the axis of said central bore and intersecting said central bore in said bone block.

21. A sterile bone-tendon-bone assembly comprising:

an allograft cancellous bone block defining an outer curved surface, a central through going bore with a substantially oval cross section and a channel cut in its outer exterior surface;

the exterior of said bone block opposite said channel being formed with a planar surface, a tendon replacement member comprising at least one tendon, said tendon extending through said central bore of said bone block and looped around said planar surface of said bone block, said tendon being secured to said bone block and at least one suture hole cut transverse to the axis of said central bore and leading to said central bore in said bone block.

22. A sterile composite graft as claimed in claim 21 wherein said tendon replacement member comprises at least one tendon selected from a group consisting of a semitendinous tendon, a patellar tendon, gracilis tendon, quadriceps tendon, adductor magnus tendon, peroneus tendons, tibialis tendons and hallucis Achilles tendon.

23. A sterile bone-tendon-bone assembly as claimed in claim 21 including a second bone member comprising another bone block, said another block defining a central through going bore with a substantially oval cross section and having a substantially similar configuration as the first bone block.

24. A sterile bone-tendon-bone assembly as claimed in claim 23 wherein said first and second bone block are constructed of allograft cancellous bone selected from a group consisting of a cancellous patella, femoral head, long bone condyles and talus.

25. A sterile bone-tendon-bone assembly as claimed in claim 23 wherein each bone block is constructed of xenograft cancellous bone.

26. A sterile bone-tendon-bone assembly as claimed in claim 21 wherein said tendon replacement member comprises a semitendinosus tendon.

27. A sterile bone-tendon-bone assembly as claimed in claim 21 wherein said tendon replacement member comprises a patellar tendon.

28. A sterile bone-tendon-bone assembly as claimed in claim 21 wherein said tendon replacement member comprises a gracilis tendon.

29. A sterile bone-tendon-bone assembly as claimed claim 21 wherein said bone block includes an additive selected from a group consisting of living cells, cell elements, chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, fibroblasts, epithelial cells and entothial cells, natural extracts, and tissue transplants.

30. A sterile bone-tendon-bone assembly claimed in claim 21 wherein said tendon replacement member comprises a plurality of tendons.

31. A sterile bone-tendon-bone assembly comprising:

first and second substantially cylindrical allograft cancellous bone blocks, each bone block defining a central through going bore, a channel cut in its outer surface and a planar surface cut on the opposite side of said bone block from said channel, a tendon replacement member extending between said first and second bone blocks through said central bore, and seated over said planar surface longitudinally alongside each of said first and second bone blocks and at least one suture hole cut transverse to said central bore away from said channel and communicating with said central bore in each of said bone blocks.

32. A sterile bone-tendon-bone assembly as claimed in claim 31 wherein said tendon replacement member comprises at least one tendon taken from a group of tendons consisting of a semitendinous tendon, a patellar tendon, gracilis tendon, quadriceps tendon, adductor magnus tendon, peroneus tendons, tibialis tendons and hallucis Achilles tendon.

33. A sterile bone-tendon-bone assembly comprising:

first and second substantially cylindrical allograft cancellous bone blocks, each of said blocks defining a central bore and a longitudinally running channel formed on the exterior surface of said bone block running the length of the bone block;

a first tendon replacement strand extending between said first and second bone blocks through said central bore and positioned on the exterior surface of each of said first and second bone blocks opposite from said longitudinal channel; and

a second tendon replacement strand extending between said first and second bone blocks through said central bore and longitudinally along the exterior surface of each of said first and second bone blocks adjacent to at least a portion of said first tendon replacement strand.

34. The sterile bone-tendon-bone assembly of claim 33 wherein said bone blocks each have at least one suture hole extending radially through said bone block from said central bore spaced away from said substantially parallel channel with a suture extending through said at least one suture hole radially cut in each of said bone blocks leading into said central bore to attach said tendon replacement strands to said first and second bone blocks.

35. The sterile bone-tendon-bone assembly of claim 33 wherein said at least one of said tendon replacement strands is xenograft tissue.

36. The sterile bone-tendon-bone assembly of claim 33 wherein said at least one of said tendon replacement strands is allograft tissue.

37. A sterile bone-tendon-bone assembly of claim 33 wherein said tendon replacement strands comprise at least one tendon taken from a group of tendons consisting of a semitendinous tendon, a patellar tendon, gracilis tendon, quadriceps tendon, adductor magnus tendon, peroneus tendons, tibialis tendons and hallucis Achilles tendon.

38. A sterile bone-tendon-bone assembly as claimed in claim 33 wherein each bone block includes an additive selected from a group consisting of living cells, cell elements, chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, fibroblasts, epithelial cells and entothial cells, natural extracts, and tissue transplants.

39. A sterile bone-tendon-bone assembly as claimed in claim 33 wherein each bone block includes an additive selected from a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1), platelet derived growth factor (PDGF), fibroblast growth factor (FGF)(Numbers 1-23), platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), osteopontin, and growth hormones.

40. A sterile bone-tendon-bone assembly as claimed in claim 33 wherein said first and second bone blocks are taken from a group of bones consisting of a cancellous patella, femoral head, long bone condyles and talus.

41. A sterile bone-tendon-bone assembly as claimed in claim 33 wherein said bone block has a pull out force when mounted in a bone tunnel of a femur with an interference screw which is greater than 200 Newtons.

42. A sterile bone-tendon-bone assembly as claimed in claim 41 wherein said pull out force ranges from about 250 Newtons to about 500 Newtons.

43. A sterile reconstructed cruciate tendon assembly comprising:

first and second allograft substantially cylindrical bone blocks;

each bone block comprising a body of cancellous bone with a central through going bore, a channel cut in the outer surface of said substantially cylindrical body and a flat surface forming a cord cut into the outer surface of substantially cylindrical body opposite said channel, a tendon replacement strand extending between said first and second bone blocks is inserted through said central bore and attached longitudinally alongside each of said first and second bone blocks adjacent said flat surface with said first and second bone blocks each having at least one suture hole extending radially through said bone block from said central bore through to an outer surface and said bone blocks have an angled beveled end surface.

44. A sterile reconstructed cruciate tendon assembly as claimed in claim 43 wherein said tendon replacement strand comprises at least one tendon taken from a group of tendons consisting of a semitendinous tendon, a patellar tendon, gracilis tendon, quadriceps tendon, adductor magnus tendon, peroneus tendons, tibialis tendons and hallucis Achilles tendon.

45. A sterile reconstructed cruciate assembly as claimed claim 43 wherein each bone block includes an additive selected from a group consisting of living cells, cell elements, chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, fibroblasts, epithelial cells and entothial cells, natural extracts, and tissue transplants.

46. A sterile bone block for use in tendon implants comprising:

a cancellous bone block body with a curved outer surface having a central through going bore with an oval shared cross section, said bone block body defining a longitudinal channel cut in an exterior surface of said bone block body running the length of the body and a flat longitudinal surface cut in an exterior surface of said bone block opposite said longitudinal channel running the entire length of the body and at least one suture hole spaced away from said longitudinal channel formed radially from an exterior surface of said bone block body extending through to the central bore.

47. A sterile bone block as claimed in claim 46 wherein an inner face of an end of said bone block body is cut on a beveled angle to provide a flush alignment of the bone block upon placement in an implant site.

48. A sterile bone block as claimed in claim 46 wherein said bone block includes an additive selected from a group consisting of living cells, cell elements, chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, fibroblasts, epithelial cells and entothial cells, natural extracts, and tissue transplants.

49. A sterile bone block as claimed in claim 46 wherein said bone block includes an additive selected from a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1), platelet derived growth factor (PDGF), fibroblast growth factor (FGF)(Numbers 1-23), platelet derived growth factor (PDGF),vascular endothelial growth factor (VEGF), osteopontin;

and growth hormones.

50. A sterile bone block as claimed in claim 46 wherein said bone block is constructed of allograft bone which is partially demineralized.

51. A sterile bone block as claimed in claim 50 wherein said bone block is constructed of allograft cancellous bone selected from a group consisting of a cancellous patella, femoral head, long bone condyles and talus.

52. A sterile bone block as claimed in claim 46 wherein said bone block has a pull out force when mounted in a bone tunnel of a tibia with an interference screw which is greater than 200 Newtons.

53. A sterile bone block as claimed in claim 52 wherein said pull out force ranges from about 250 Newtons to about 500 Newtons.

54. A sterile composite graft comprising:

first and second allograft cancelleous bone blocks, each bone block defining a central through going bore having a cross section which will allow a ligament replacement to be passed therethrough and at least one longitudinal channel cut substantially parallel to the axis of the central through going bore in the exterior surface of said bone block, a ligament replacement mounted to said bone blocks, said ligament replacement extending through said central bore of said bone blocks and looped around said first and second bone blocks, said bone block when mounted in a bone tunnel with an interference screw having a pull out force which is greater than 200 Newtons.

55. A sterile composite graft as claimed in claim 54 wherein said ligament replacement comprises at least one tendon selected from a group consisting of a semitendinous tendon, a patellar tendon, gracilis tendon, quadriceps tendon, adductor magnus tendon, peroneus tendons, tibialis tendons and hallucis Achilles tendon.

56. A sterile composite graft as claimed in claim 54 wherein said first and second bone blocks define a central through going bore has a substantially oval cross section and further includes at least one suture hole drilled radially through each of said bone blocks spaced away from the longitudinal channel through to the central bore.

57. A sterile composite graft as claimed in claim 54 wherein said bone block includes an additive selected from a group consisting of living cells, cell elements, chondrocytes, red blood cells, white blood cells, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, osteoclasts, fibroblasts, epithelial cells and entothial cells, natural extracts, and tissue transplants.

58. A sterile composite graft as claimed in claim 54 wherein said bone block has a pull out force when mounted in a bone tunnel of a tibia with an interference screw which ranges from about 250 Newtons to about 500 Newtons.

59. A sterile composite graft as claimed in claim 54 wherein said bone block also includes a flat surface running the longitudinal length of the bone block positions opposite a longitudinal channel.

60. A sterile composite graft as claimed in claim 54 wherein said bone block includes an additive selected from a group consisting of transforming growth factor (TGF-beta), insulin growth factor (IGF-1), platelet derived growth factor (PDGF), fibroblast growth factor (FGF)(Numbers 1-23), platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), osteopontin;

and growth hormones.

61. A sterile composite graft as claimed in claim 60 wherein said growth hormones is somatotropin.