Assembled bone-tendon-bone grafts

• US 20060200235A1
• Filed: 03/04/2005
• Published: 09/07/2006
• Est. Priority Date: 03/04/2005
• Status: Active Grant

• Current Assignee: RTI Surgical Incorporated
• Original Assignee: Regeneration Technologies Incorporated (Surgalign Holdings, Inc.)
• Inventors: Bianchi, John R., Sanders, Ben R., Klein, Glenn C., Carr, Angela, Urbaniak, Dan, Kutsavage, Joe, Lewis, Wesley I.
• Granted Patent: US 7,776,089 B2
• Time in Patent Office: Days
• US Class Current: 623/13.140
• 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 2002/087 Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts

Abstract

The present invention has multiple aspects. In its simplest aspect, the present invention is directed to an intermediate bone block comprising a machined segment of cortical bone, cancellous bone or both, the intermediate having a face comprising one to ten compression surfaces and one to ten cavities, the compression surfaces suitable for compressing soft tissue, the cavities for receiving and holding overflow soft tissue. The cavities are preferably channels, and more preferably channels having an omega cross-sectional profile. Surprisingly, the cavities and channels, which reduced the compressed surface area between the intermediate bone block and the tendon, significantly improved tendon load at failure. In standardized tests, an intermediate bone block of this invention, when combined with high surface area bone blocks of the prior art bone blocks, unexpectedly increased their load at failure. The invention is also directed to bone block assemblies suitable for binding to a soft tissue to form an implantable graft, and to such implantable grafts. A particularly preferred graft is a bone-tendon-bone graft.

Claims

1. An assembled implant comprising at least one bone block assembly for securing soft tissue, and a segment of soft tissue of sufficient length to extend beyond said bone block assembly, said bone block assembly comprising two to ten components of cortical bone, cancellous bone, artificial bone or a combination thereof, wherein said soft tissue is sandwiched between at least two of said components, and said components being connected by one to ten biocompatible connectors, at least two of said components having opposing faces that contact opposing sides of said soft tissue, said opposing faces being a first opposing face and a second opposing face, said first opposing face comprising compression surfaces and one to ten cavities, said compression surfaces for compressing said soft tissue against the opposing face, and said cavities for receiving overflow soft tissue from said compression surfaces.

2. The assembled implant of claim 1, wherein said components comprise cortical bone, cancellous bone or both.

3. The assembled implant of claim 1, wherein said soft tissue comprises allograft tissue, autograft tissue, xenograft tissue, an engineered construct of natural or synthetic origin or a combination thereof.

4. The assembled implant of claim 3, wherein said soft tissue is selected from the group consisting of one to ten tendons, one to ten ligaments, an isolated segment or segments of pericardium, dermis, fascia, dura, skin, submucosal tissue, cartilage, or a combination thereof.

5. The assembled implant of claim 4, wherein said soft tissue is one to ten tendons.

6. The assembled implant of claim 5, wherein said one to ten tendons are treated with a crosslinking agent.

7. The assembled implant of claim 5, wherein two to ten tendons are used, said tendons being of different lengths.

8. The assembled implant of claim 5, wherein two to ten tendons are used, said tendons being of different cross-sectional area.

9. The assembled implant of claim 5, wherein two to ten tendons are used, said tendons being of different anatomical origins.

10. The assembled implant of claim 1, further comprising one to ten machined holes that traverse either said bone block assembly as a whole or a single component thereof.

11. The assembled implant of claim 1, further comprising a depression on at least one of said components that aids in surgical placement.

12. The assembled implant of claim 1, wherein said components have an outer surface that is shaped to aid in surgical placement.

13. The assembled implant of claim 12, wherein the outer surface has a shape selected from the group consisting of polygonal, cylindrical, threaded, bulleted, chamfered, angled, ridged, capsule shaped, tapered and a combination thereof.

14. The assembled implant of claim 12, wherein the outer surface contains spikes or indentations.

15. The assembled implant of claim 1, at least one of said components comprise one to five grooves on an outer surface to accommodate one or more interference screws.

16. The assembled implant of claim 15, wherein said grooves comprise threads or tapped threads.

17. The assembled implant of claim 15, further comprising two equally placed grooves on an outer surface to accommodate one or more interference screws.

18. The assembled implant of claim 1, further comprising a groove on an outer surface of said bone block assembly to accommodate said soft tissue.

19. The assembled implant of claim 1, wherein any of said components comprise an internal leading edge configuration that reduces tissue stresses during assembly and use.

20. The assembled implant of claim 1, wherein at least one of the opposing faces contains a lengthwise tapering profile.

21. The assembled implant of claim 1, wherein said first opposing face comprises compression surfaces and two to five cavities.

22. The assembled implant of claim 1, wherein said first opposing face is given a surface treatment to produce a textured surface.

23. The assembled implant of claim 1, wherein said one to ten cavities comprise one to ten channels.

24. The assembled implant of claim 23, wherein said channels comprise a cross-sectional profile selected from the group consisting of rectangular, square, semi-circular, semi-ovular, triangular, trapezoidal, sinusoidal, curvilinear, dovetail, omega and a combination thereof.

25. The assembled implant of claim 1, wherein said said second opposing face comprises a face that is textured.

26. The assembled implant of claim 25, wherein said textured face comprises striations.

27. The assembled implant of claim 1, wherein said one to ten cavities comprise one to ten channels;

and said second opposing face comprises striations.

28. The assembled implant of claim 27, wherein at least one of said channels comprises an omega profile.

29. The assembled implant of claim 1, wherein said implant is perfused or coated with an osteoinductive substance.

30. The assembled implant of claim 1, wherein said soft tissue is a of one to ten tendons having a first end and a second end.

31. The assembled implant of claim 30, wherein only said first end of said one to ten tendons has a bone block assembly associated therewith.

32. The assembled implant of claim 1, wherein said segment of soft tissue is sufficiently large so that excess tissue extends beyond the end or sides of said bone block assembly.

33. The assembled implant of claim 1, wherein at least one of said components have an outer surface that is partially demineralized.

34. The assembled implant of claim 1, wherein said implant is cleaned or perfused by treatment with a pressure cycling process.

35. The assembled implant of claim 1, wherein at least one of said components are themselves assembled from smaller portions of cortical bone, cancellous bone, artificial bone or a combination thereof.

36. An assembled implant comprising at least one bone block assembly for securing soft tissue, and a segment of soft tissue of sufficient length to extend beyond said bone block assembly, said bone block assembly comprising two to ten components of cortical bone, cancellous bone, artificial bone or a combination thereof, wherein said soft tissue is sandwiched between at least two of said components, and said components being connected by one to ten biocompatible connectors, at least two of said components having opposing faces for contacting opposing sides of said soft tissue, wherein at least one component has a face comprising one or more compression surfaces and one to ten cavities, said compression surfaces for compressing said soft tissue against the opposing face, and said cavities for receiving overflow soft tissue from said compression surfaces;

wherein said cavities comprise an undercut cross-sectional profile.

37. The assembled implant of claim 36, wherein said undercut cross-sectional profile comprises an omega profile.

38. A bone block assembly for securing soft tissue, said bone block assembly comprising two to ten components of cortical bone, cancellous bone, artificial bone or a combination thereof, wherein said soft tissue is sandwiched between at least two of said components, and said components being connected by one to ten biocompatible connectors, at least two of said components having opposing tissue engaging surfaces that contact opposing sides of said soft tissue, at least one of said tissue engaging surfaces comprising:

a face comprising compression surfaces and one to ten channels, said compression surfaces for compressing said soft tissue against the opposing face, and said one to ten channels for receiving overflow soft tissue from said compression surfaces.

39. The bone block assembly of claim 38, wherein said components comprise cortical bone, cancellous bone or both.

40. The bone block assembly of claim 38, further comprising one to ten machined holes that traverse either the bone block assembly as a whole or a single component thereof.

41. The bone block assembly of claim 38, further comprising a depression on at least one of said components that aids in surgical placement.

42. The bone block assembly of claim 38, wherein said components have an outer surface that is shaped to aid in surgical placement.

43. The bone block assembly of claim 42, wherein the outer surface has a shape selected from the group consisting of polygonal, cylindrical, threaded, bulleted, chamfered, angled, ridged, capsule shaped, tapered and a combination thereof.

44. The bone block assembly of claim 42, wherein the outer surface contains spikes or indentations.

45. The bone block assembly of claim 38, wherein at least one of said components comprise one to five grooves on an outer surface to accommodate one or more interference screws.

46. The bone block assembly of claim 45, wherein said grooves comprise threads or tapped threads.

47. The bone block assembly of claim 45, further comprising two equally placed grooves on an outer surface to accommodate one or more interference screws.

48. The bone block assembly of claim 38, further comprising a groove on an outer surface of said bone block assembly to accommodate said soft tissue.

49. The bone block assembly of claim 38, wherein any of said components comprise an internal leading edge configuration that reduces tissue stresses during assembly and use.

50. The bone block assembly of claim 38, wherein at least one of the opposing faces contain a lengthwise tapering profile.

51. The bone block assembly of claim 38, wherein said channels have an undercut cross-sectional profile.

52. The bone block assembly of claim 51, wherein the compression surfaces are given a surface treatment to produce a textured surface.

53. The bone block assembly of claim 51, wherein said undercut cross-sectional profile is an omega cross-sectional profile.

54. The bone block assembly of claim 38, wherein said channels comprise a cross-sectional profile selected from the group consisting of rectangular, square, semi-circular, semi-ovular, triangular, trapezoidal, sinusoidal, curvilinear, dovetail, omega and a combination thereof

55. The bone block assembly of claim 38, wherein one of said tissue engaging surfaces is textured.

56. The bone block assembly of claim 55, wherein said textured face comprises rows of ridges running across the intended direction of pull of the tendon.

57. The bone block assembly of claim 38, wherein one soft tissue engaging surface comprises compression surfaces and one to ten channels;

and the opposing soft tissue engaging surface comprises rows of ridges running substantially perpendicular to the long side of the bone block.

58. The bone block assembly of claim 57, wherein at least one of said channels comprises an omega cross sectional profile.

59. The bone block assembly of claim 38, wherein at least one of said components is perfused or coated with an osteoinductive substance.

60. The bone block assembly of claim 38, wherein at least one of said components has an outer surface that is partially demineralized.

61. The bone block assembly of claim 38, wherein at least one of said components is cleaned or perfused by treatment with an alternating pressure cycling process.

62. The bone block assembly of claim 38, wherein at least one of said components are themselves assembled from smaller portions of cortical bone, cancellous bone, artificial bone or a combination thereof.

63. A bone block assembly for securing soft tissue, said bone block assembly comprising two to ten components of cortical bone, cancellous bone, artificial bone or a combination thereof, wherein said soft tissue is sandwiched between at least two of said components, and said components being connected by one to ten biocompatible connectors, at least two of said components having opposing faces for contacting opposing sides of said soft tissue, wherein at least one component has a face comprising one or more compression surfaces and one to ten cavities, said compression surfaces for compressing said soft tissue against the opposing face, and said cavities for receiving overflow soft tissue from said compression surfaces;

wherein said cavities comprise an undercut cross-sectional profile.

64. The bone block assembly of claim 63, wherein said undercut cross-sectional profile comprises an omega profile.

65. An intermediate bone block comprising a machined segment of cortical bone, cancellous bone, artificial bone or a combination thereof, said intermediate having a soft tissue engaging surface comprising one to ten compression surfaces and one to ten cavities, said compression surfaces suitable for compressing soft tissue, said one to ten cavities comprising an omega cross-sectional profile.

66. The intermediate bone block of claim 65, wherein said one to ten cavities are laid out as one to ten channels across the tissue engaging surface.

67. The intermediate bone block of claim 66, wherein at least a portion of one of said channels is laid out the direction of the length of said intermediate bone block.

68. The intermediate bone block of claim 67, wherein the layout of one of said channels is linear.

69. The intermediate bone block of claim 67, wherein the layout of one of said channels is V-shaped.

70. The intermediate bone block of claim 67, wherein the layout of one of said channels is U-shaped.

71. An assembled implant comprising a first and second bone portion, and a segment of soft tissue of sufficient length to extend between said first and second bone portions, wherein

said first bone portion is attached to said segment of soft tissue by a naturally occurring attachment, and

said second bone portion is a bone block assembly for securing soft tissue comprising an upper component and a lower component of cortical bone, cancellous bone, artificial bone or a combination thereof, said upper component and said lower component sandwiching said soft tissue therebetween and being connected by one to ten biocompatible connectors.

72. The assembled implant of claim 71, wherein said first bone portion attached to said segment of soft tissue by a naturally occurring attachment is reinforced by a machined portion of bone that is connected thereto by one to ten biocompatible connectors.

73. An assembled implant comprising a first and second bone portion, and a segment of soft tissue of sufficient length to extend between said first and second bone portions, wherein

said first bone portion is attached to said segment of soft tissue by a naturally occurring attachment, and

said second bone portion is an intermediate bone block for securing soft tissue comprising cortical bone, cancellous bone, artificial bone or a combination thereof, said intermediate bone block having a face comprising compression surfaces and one to ten cavities, said compression surfaces for compressing said soft tissue, and said cavities for receiving overflow soft tissue from said compression surfaces;

wherein said cavities comprise an undercut cross-sectional profile.

74. The assembled implant of claim 73, wherein said first bone portion attached to said segment of soft tissue by a naturally occurring attachment is reinforced by a machined portion of bone that is connected thereto by one to ten biocompatible connectors.

75. The assembled implant of claim 73, wherein said undercut cross-sectional profile comprises an omega profile.