Screws of cortical bone and method of manufacture thereof

• US 7,094,239 B1
• Filed: 05/05/2000
• Issued: 08/22/2006
• Est. Priority Date: 05/05/1999
• Status: Expired due to Fees

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Michelson, Gary K.
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/566,055
• Time in Patent Office: 2,300 Days
• Field of Search: 606/60, 606/61, 606/65, 606/69, 606/72, 606/73, 606/76, 606/77, 606/70
• US Class Current: 606/70
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/8033 having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
• CPC Class Codes: A61B 17/8038 the additional component being inserted in the screw head
• CPC Class Codes: A61B 17/8042 the additional component being a cover over the screw head
• CPC Class Codes: A61B 17/8057 the interlocking form comprising a thread
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/888 the driver bit acting on the central region of the screw head
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30797 internally-threaded
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: Y10S 606/909 : Bone
• CPC Class Codes: Y10T 29/49947 : by applying separate fastener

Abstract

A screw formed of cortical bone for use in the human body with an implant having a screw hole for receiving at least a portion of a screw therethrough, includes a shaft with a thread along at least a portion of its length. The thread has an outer diameter dimensioned to pass through the screw hole in the implant. The trailing end of the screw is configured to cooperatively engage at least a portion of the screw hole of the implant so as to prevent the screw from linear motion along the mid-longitudinal axis of the shaft in a direction opposite to the direction of insertion when the screw is threaded through the screw hole to attach the implant to a bone portion of the human body. The screw is formed substantially of cortical bone of a single cortical thickness.

Claims

1. An apparatus for locking bone screws formed of cortical bone for use in the human body to an implant having a screw hole for receiving at least a portion of a screw therethrough, said apparatus comprising:

at least one bone screw formed substantially of cortical bone of a single cortical thickness, said screw having a leading end, a trailing end opposite said leading end, and a shaft therebetween, said shaft having a mid-longitudinal axis and a length, a thread extending from said shaft along at least a portion of its length, said thread having an outer diameter dimensioned to pass through the screw hole in the implant, said screw having an enlarged portion proximate said trailing end with a dimension transverse to the mid-longitudinal axis of said shaft greater than said outer diameter of said thread, said enlarged portion configured to prevent said head from passing through the screw hole in the implant; and

a screw lock formed substantially of cortical bone configured to cooperatively engage at least a portion of the implant so as to prevent said screw from linear motion along the mid-longitudinal axis of said shaft in a direction opposite to the direction of insertion when said screw is inserted through the screw hole to attach the implant to a bone portion of the human body.

2. The apparatus of claim 1, wherein said lock is made of cortical bone of a single cortical thickness.

3. The apparatus of claim 1, wherein said lock includes a threaded perimeter.

4. The apparatus of claim 1, wherein said lock has a head and a threaded shaft adapted to screw into the implant.

5. The apparatus of claim 1, wherein said lock is configured to engage a driving instrument.

6. The apparatus of claim 1, wherein said lock includes a recess.

7. The apparatus of claim 6, wherein said recess is cruciate.

8. The apparatus of claim 6, wherein said recess is hex-shaped.

9. The apparatus of claim 1, wherein said lock includes an opening for allowing a portion of the a driving instrument to pass through said lock.

10. The apparatus of claim 1, wherein said lock includes a protrusion protruding therefrom.

11. The apparatus of claim 10, wherein said protrusion has a hex-shaped perimeter.

12. The apparatus of claim 1, wherein said lock is part of a screw head.

13. The apparatus of claim 1, in combination with an implant having at least one bone screw receiving hole and a screw lock receiving aperture associated with said bone screw receiving hole.

14. The apparatus of claim 13, wherein said bone screw receiving hole and said screw lock receiving aperture are coaxial and said screw lock cooperatively engages at least a portion of said screw lock receiving aperture to lock a bone screw to said implant.

15. The apparatus of claim 14, wherein said lock is threaded.

16. The apparatus of claim 1, wherein said implant is one of a plate, spinal fusion implant, and cortical bone dowel.

17. The apparatus of claim 1, wherein said enlarged portion forms a head.

18. The apparatus of claim 1, wherein said enlarged portion forms a lip.

19. The apparatus of claim 1, wherein said trailing end includes a second thread having a different thread pitch than said thread along said shaft.

20. The apparatus of claim 19, wherein the thread pitch of said second thread is similar to a metal screw pitch.

21. The apparatus of claim 19, wherein the thread pitch of said thread along said shaft is similar to a wood screw pitch.

22. The apparatus of claim 1, wherein the thread pitch of said thread along said shaft is similar to a metal screw pitch.

23. The apparatus of claim 1, wherein at least a portion of said trailing end is configured to cooperatively engage a driving instrument for insertion of said screw.

24. The apparatus of claim 23, wherein said trailing end includes the recess to cooperatively engage a driving instrument.

25. The apparatus of claim 24, wherein said recess is one of cruciate-shaped and hex-shaped.

26. The apparatus of claim 23, wherein said trailing end includes the protrusion to cooperatively engage a driving instrument.

27. The apparatus of claim 26, wherein said protrusion has a hex-shaped perimeter.

28. The apparatus of claim 1, wherein said thread is sharper proximate said leading end than proximate said trailing end.

29. The apparatus of claim 1, wherein said thread has a V-shaped cross section with an apex and a base adjacent to said shaft, said base being substantially wider than said apex.

30. The apparatus of claim 1, wherein said thread has a peak as measured from said shaft, the peak being greater proximate said leading end than said trailing end.

31. The apparatus of claim 1, wherein said shaft has a root diameter that increases in the direction from said leading end to said trailing end.

32. The apparatus of claim 1, wherein said leading end forms a tip and said tip is fluted.

33. The apparatus of claim 1, wherein said cortical bone is obtained from a human.

34. The apparatus of claim 1, wherein said cortical bone is obtained from a generally intramembraneously formed cortical bone.

35. The apparatus of claim 34, wherein said cortical bone is obtained from a human skull.

36. The apparatus of claim 1, wherein said cortical bone is obtained from a large tubular bone of a human.

37. The apparatus of claim 36, wherein said cortical bone is from the diaphyseal region of the tubular bone.

38. The apparatus of claim 36, wherein the tubular bone is a femur.

39. The apparatus of claim 1, wherein said screw comprises bone growth promoting material.

40. The apparatus of claim 39, wherein said bone growth promoting material is selected from one of bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone.

41. The apparatus of claim 1, wherein said screw is treated with a bone growth promoting substance.

42. The apparatus of claim 1, in combination with a bone growth promoting material.

43. The apparatus of claim 42, wherein said bone growth promoting material includes at least one of bone morphogenetic protein, mineralizing proteins, hydroxyapatite, and genetic material coding for the production of bone.

44. The apparatus of claim 1, in combination with a bone cutting device.

45. The combination of claim 44, wherein said bone cutting device includes at least one of a saw, water jet, and trephine.

46. The apparatus of claim 1, in combination with a chemical for sterilizing said bone screw.

47. The apparatus of claim 1, in combination with a biologically active chemical agent.

48. The combination of claim 47, wherein said biologically active chemical agent includes an antibiotic.

49. The apparatus of claim 1, in combination with at least one container configured to hold said bone screw.

50. An apparatus for locking bone screws formed of cortical bone for use in the human body to an implant having a screw hole for receiving at least a portion of a screw therethrough, said screw comprising:

at least one bone screw formed substantially of cortical bone of a single cortical thickness, said screw having a leading end, a trailing end opposite said leading end, and a shaft therebetween, said shaft having a mid-longitudinal axis and a length, a thread extending form said shaft along at least a portion of its length, said thread having an outer diameter dimensioned to pass through the screw hole in the implant, said screw having an enlarged portion proximate said trailing end with a dimension transverse to the mid-longitudinal axis of said shaft greater than said outer diameter of said thread, said enlarged portion configured to prevent said enlarged portion from passing through the screw hole in the implant; and

a screw lock formed substantially of cortical bone configured to cooperatively engage at least a portion of the implant so as to prevent said screw from linear motion along the mid-longitudinal axis of said shaft in a direction opposite to the direction of insertion when said screw is inserted through the screw hole to attach the implant to a bone portion of the human body, said lock having a bottom surface configured for cooperating with at least one of said screws.

51. The apparatus of claim 50, wherein said lock includes a threaded perimeter.

52. The apparatus of claim 50, wherein said lock has a head and a threaded shaft adapted to screw into the implant.

53. The apparatus of claim 50, wherein said lock includes an opening for allowing a portion of an instrument drive to pass through said lock.

54. The apparatus of claim 50, in combination with an implant having at least one bone screw receiving hole and a screw lock receiving aperture associated with said bone screw receiving hole.

55. The apparatus of claim 54, wherein said bone screw receiving hole and said screw lock receiving aperture are coaxial and said screw lock cooperatively engages at least a portion of said screw lock receiving aperture to lock a bone screw to said implant.

56. The apparatus of claim 50, wherein said implant is one of a plate, spinal fusion implant, and cortical bone dowel.

57. The apparatus of claim 50, in combination with a bone growth promoting material.

58. The apparatus of claim 57, wherein said bone growth promoting material includes at least one of bone morphogenetic protein, mineralizing proteins, hydroxyapatite, and genetic material coding for the production of bone.

59. The apparatus of claim 50, in combination with a chemical for sterilizing said bone screw.

60. An apparatus for locking bone screws formed of cortical bone for use in the human body to an implant having a screw hole for receiving at least a portion of a screw therethrough, said screw comprising:

at least one bone screw formed substantially of cortical bone of a single cortical thickness, said screw having a leading end, a trailing end opposite said leading end, and a shaft therebetween, said shaft having a mid-longitudinal axis and a length, a thread extending from said shaft alonge at least a portion of its lenght, said thred having an outer diameter dimensioned to pass through the screw hole in the implant, said screw having an enlarged portion proximate said trailing end with a dimension transverse to the mid-longitudinal axis of said shaft greater than said outer diameter of said thread, said enlarged portion configured to prevent said enlarged portion from passing through the screw hole in the implant; and

a screw lock formed substanitally of cortical bone configured to cooperatively engage at least a portion of the implant so as to prevent said screw from linear motion along the mid-longitudinal axis shaft in a direction opposite to the direction of insertion when said screw is inserted through the screw hole to attach the implant to a bone portion of the human body, said lock having at least one removed portion to permit insertion of at least one of said screws into a bone screw receiving hole when said lock is attached to the implant when said lock is in a first position, said lock being adapted to lock at least one of said screws to the implant when moved to a second position.

61. The apparatus of claim 60, wherein said lock includes a threaded perimeter.

62. The apparatus of claim 60, wherein said lock has a head and a threaded shaft adapted to screw into the implant.

63. The apparatus of claim 60, wherein said lock includes an opening for allowing a portion of an instrument driver to pass through said lock.

64. The apparatus of claim 60, in combination with an implant having at least one bone screw receiving hole and a screw lock receiving aperture associated with said bone screw receiving hole.

65. The apparatus of claim 64, wherein said bone screw receiving hole and said screw lock receiving aperture are coaxial and said screw lock cooperatively engages at least a portion of said screw lock receiving aperture to lock a bone screw to said implant.

66. The apparatus of claim 60, wherein said implant is one of a plate, spinal fusion implant, and cortical bone dowel.

67. The apparatus of claim 60, in combination with a bone growth promoting material.

68. The apparatus of claim 67, wherein said bone growth promoting material includes at least one of bone morphogenetic protein, mineralizing proteins, hydroxyapatite, and genetic material coding for the production of bone.

69. The apparatus of claim 60, in combination with a chemical for sterilizing said bone screw.

70. An apparatus for locking bone screws formed of cortical bone for use in the human body to an implant having a screw hole for receiving at least a portion of a screw therethrough, said screw comprising:

at least one bone screw formed substantially of cortical bone of a single cortical thickness, said screw having a leading end, a trailing end opposite said leading end, and a shaft therebetween, said shaft having a mid-longitudinal axis and a length, a thread extending from said shaft along at least a portion of its length, said thread having an outer diameter dimensioned to pass through the screw hole in the implant, said screw having an enlarged portion proximate said trailing end with a dimension transverse to the mid-longitudinal axis of said shaft greater than said outer diameter of said thread, and enlarged portion configured to prevent said enlarged portion form passing through the screw hole in the implant, at least a portion of said trailing end of said bone screw being expandable; and

a screw lock formed substantially of cortical bone configured to cooperatively engage at least a portion of the implant so as to prevent said screw from linear motion along the mid-longitudinal axis of said shaft in a direction opposite to the direction of insertion when said screw is inserted through the screw hole to attach the implant to a bone portion of the human body.

71. The apparatus of claim 70, wherein said lock includes a threaded perimeter.

72. The apparatus of claim 70, wherein said lock has a head and a threaded shaft adapted to screw into the implant.

73. The apparatus of claim 70, wherein said lock includes an opening for allowing a portion of an instrument driver to pass through said lock.

74. The apparatus of claim 70, in combination with an implant having at least one bone screw receiving hole and a screw lock receiving aperture associated with said bone screw receiving hole.

75. The apparatus of claim 74, wherein said bone screw receiving hole and said screw lock receiving aperture are coaxial and said screw lock cooperatively engages at least a portion of said screw lock receiving aperture to lock a bone screw to said implant.

76. The appartus of claim 70, wherein said implant is one of a plate, spinal fusion implant, and cortical bone dowel.

77. The apparatus of claim 70, in combination with a bone growth promoting material.

78. The appartus of claim 77, wherein said bone growth promoting material includes at least one of bone morphogenetic protein, mineralizing proteins, hydroxyapatite, and genetic material coding for the production of bone.

79. The apparatus of claim 70, in combination with a chemical for sterilizing said bone screw.

80. The apparatus of claim 70, wherein at least a portion of said trailing end is divided into at least two members with an opening therebetween.

81. The apparatus of claim 80, further comprising an insert configured to fit into said opening of said trailing end and to move said at least two members apart when inserted into said opening.

82. The apparatus of claim 81, wherein said insert is configured to be inserted by linear advancement into said opening.

83. The apparatus of claim 82, wherein said insert has a cruciate shape and said opening has a corresponding cruciate shape.

84. The apparatus of claim 81, wherein said insert is configured to be inserted by rotational movement into said opening.

85. The apparatus of claim 84, wherein said insert is threaded.

86. An appartus for locking bone screws formed of cortical bone for use in the human body to an implant having a screw for receiving at least a portion of a screw therethrough, said screw comprising:

at least one bone screw formed substantially of cortical bone of a single cortical thickness, said screw having a leading end, a trailing end opposite said leading end, and a shaft therebetween, said shaft having a mid-longitudinal axis and a length, a thread extending from said shaft along at least a portion of its length, said thread having an outer diameter dimensioned to pass through the screw hole in the implant said screw having an enlarged portion proximate said trailing end with a dimension transverse to the mid-longitudinal axis of said shaft greater than said outer diameter of said thread, said enlarged portion configured to prevent said enlarged portion from passing through the screw hole in the implant;

a screw lock formed substantially of cortical bone configured to cooperatively engage at least a portion of the implant so as to prevent said screw from linear motion along the mid-longitudinal axis of said shaft in a direction opposite to the direction of insertion when said screw is inserted through the screw hole to attach the implant to a bone portion of the human body; and

a bioreasorbable material other than cortical bone.

87. The apparatus of claim 86, wherein said lock includes a threaded perimeter.

88. The apparatus of claim 86, wherein said lock has a head and a threaded shaft adapted to screw into the implant.

89. The apparatus of claim 86, wherein said lock includes an opening for allowing a portion of an instrument driver to pass through said lock.

90. The apparatus of claim 86, in combination with an implant having at least one bone screw receiving hole and a screw lock receiving aperture associated with said bone screw receiving hole.

91. The apparatus of claim 90, wherein said bone screw receiving hole and said screw lock receiving aperture are coaxial and said screw lock cooperatively engages at least a portion of said screw lock receiving aperture to lock a bone screw to said implant.

92. The apparatus of claim 86, wherein said implant is one of a plate, spinal fusion implant, and cortical boe dowel.

93. The apparatus of claim 86, in combination with a bone growth promoting material.

94. The apparatus of claim 93, wherein said bone growth promoting material includes at least one of bone morphogenetic protein, mineralizing proteins, hydrozyapatite, and genetic material coding for the production of bone.

95. The apparatus of claim 86, in combination with a chemical for sterilizing said bone screw.

96. The apparatus of claim 86, wherein said material includes bioresorbable plastics.

97. The apparatus of claim 96, wherein said material includes at least one of glycolide polymers, lactide, capralactone, trimethylene carbonate, and dioxanone.