Fixation devices

• US 5,968,047 A
• Filed: 07/06/1998
• Issued: 10/19/1999
• Est. Priority Date: 04/05/1996
• Status: Expired due to Term

• Current Assignee: Solana Surgical LLC (Stryker Corporation)
• Original Assignee: Thomas Mills Reed
• Inventors: Reed, Thomas Mills
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): WOO, JULIAN W
• Application Number:
  US09/110,507
• Time in Patent Office: 470 Days
• Field of Search: 606/69, 606/76, 606/77, 606/72, 606/73, 606/104
• US Class Current: 606/76
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: Y10S 606/909 Bone
• CPC Class Codes: Y10S 606/916 Tool for installing or removing orthopedic fastener

Abstract

Sterile bone fixation devices, such as bone screws, pins, anchors and plates, fabricated from bone tissue and the method of making such devices.

Claims

1. A fixation device formed in the shape of a screw, said fixation device made of human or animal cortical bone, said fixation device being grafted into a biologically active structure, said fixation device being interactive with said structure and forming a part of said structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) a head portion functionally adapted to provide rotational movement to said fixation device;

b) said head portion being fixedly attached to a longitudinal body portion, said head portion being cylindrical and having a slot, said slot being perpendicular to said longitudinal body portion and adapted to receive a rotational tool; and

c) said longitudinal body portion being at least partially threaded with a thread pitch of 0.5 to 3.0 mm, said longitudinal body portion having a threaded diameter ranging from 1 to 8 mm and a core diameter from 1 to 8 mm.

2. The fixation device of claim 1 wherein said slot being shaped in the form of a cruciform recess.

3. The fixation device of claim 1 wherein said slot being shaped to receive a Philip'"'"'s head rotational tool.

4. The fixation device of claim 1 wherein said fixation device is adapted to be inserted into human or animal bone tissue.

5. The fixation device of claim 1 wherein the end of said fixation device opposite said head portion is a point.

6. The fixation device of claim 1 wherein said fixation device having a plurality of perforations on said longitudinal body portion.

7. The fixation device of claim 6 wherein said perforations piercing the surface of said longitudinal body and not extending through said longitudinal body.

8. The fixation device of claim 1 wherein said head portion is larger in diameter than the threaded diameter of said longitudinal body portion.

9. The fixation device of claim 8 wherein said head portion of the screw is cylindrical and has at least two flat sides.

10. The fixation device of claim 8 wherein said head portion has a head diameter in the range of 1 to 12 mm.

11. The fixation device of claim 8 wherein said head portion has at least one aperture, wherein at least one of said apertures is perpendicular to the longitudinal body portion and is of a configuration sufficient to accommodate at least one suture.

12. The fixation device of claim 8 wherein said fixation device has at least one aperture through said head portion.

24. A method of making said fixation device of claim 1 comprising machining human or animal cortical bone tissue into the shape of a screw under conditions that do not allow the surface temperature of said bone tissue to exceed a temperature at which said bone tissue is burned or damaged and that allow said fixation device to be sterilized sufficiently to be acceptable to use in the fixation of living bone.

25. The method of claim 24 wherein said bone tissue is sterile prior to machining, the machining is carried out using a cooling lubricant, and said fixation device is sterilized after completion.

50. The fixation device of claim 1 wherein said fixation device has an aperture extending along the entire longitudinal axis, said aperture having a configuration sufficient to allow the insertion of a pin.

51. The fixation device of claim 1 wherein said fixation device has an aperture extending along the entire longitudinal axis, said aperture having a configuration sufficient to allow the insertion of a wire.

13. A fixation device formed in the shape of a screw, said fixation device being adapted to be grafted into a biologically active structure, said fixation device being interactive with said structure and forming a part of said structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) a head portion functionally adapted to provide rotational movement to said fixation device, said head portion being larger in diameter than the longitudinal body portion, said head portion diameter ranging from about 1 to 12 mm, and said head portion being cylindrical with at least two flat sides;

b) said head portion being fixedly attached to a longitudinal body portion; and

c) said longitudinal body portion including means being at least partially threaded, and said longitudinal body portion having a threaded diameter ranging from 1 to 8 mm.

14. The fixation device of claim 13 wherein said head portion is adapted to receive a rotational tool.

15. The fixation device of claim 13 wherein said head portion has a slot, said slot being perpendicular to said longitudinal body portion and adapted to receive a rotational tool.

16. The fixation device of claim 13 wherein said fixation device is adapted to be inserted into human or animal bone tissue.

17. The fixation device of claim 13 wherein said fixation device is not biologically toxic.

18. The fixation device of claim 13 wherein said fixation device is non-metallic.

19. The fixation device of claim 13 wherein said fixation device is made from human or animal cortical bone tissue.

20. The fixation device of claim 13 wherein said fixation device having a plurality of perforations on said longitudinal body portion.

52. The fixation device of claim 13 wherein said fixation device has an aperture extending along the entire longitudinal axis, said aperture having a configuration sufficient to allow the insertion of a pin.

53. The fixation device of claim 13 wherein said fixation device has an aperture extending along the entire longitudinal axis, said aperture having a configuration sufficient to allow the insertion of a wire.

54. The fixation device of claim 13 wherein said head portion being cylindrical with only two flat sides.

55. The fixation device of claim 13 wherein said head portion being cylindrical with only three flat sides.

56. The fixation device of claim 13 wherein said head portion having at least one aperture extending through the width of said head portion.

57. The fixation device of claim 13 wherein said longitudinal body portion having at least one aperture perpendicular to said longitudinal body portion, said head portion having at least one aperture, wherein at least one of said apertures of said head portion is parallel to the longitudinal body portion and is of a configuration sufficient to accommodate at least one suture.

58. The fixation device of claim 20 wherein said perforations piercing the surface of said longitudinal body and not extending through said longitudinal body.

21. A kit comprising:

(1) a bone screw made from bone tissue, and (2) an adapter made of surgical steel having one end with a recess sized to mesh with the head of said screw and the other end having a screw head recess, sized to allow use of a driver to drive said bone screw.

22. A kit comprising:

(1) a bone screw made from bone tissue, and (2) an adapter made of surgical steel having one end with a recess sized to mesh with the head of said screw and the other end having a cruciform recess, sized to allow use of a Philip'"'"'s driver to drive said bone screw.

23. A bone fixation device formed in the shape of a screw with a head portion and a longitudinal body portion, said fixation device being made of human or animal cortical bone tissue, said fixation device being able to be grafted into a biologically active structure, said fixation devices becomes part of said structure and need not be removed, said fixation device comprising:

a) said head portion functionally adapted to provide rotational movement to said fixation device, said head portion being adapted to receive a rotational tool, said head portion being larger in diameter than the longitudinal body portion, said head diameter ranging from 2 to 10 mm, and said head portion being cylindrical with at least two flat sides;

b) said head portion being fixedly attached to said longitudinal body portion; and

c) said longitudinal body portion being at least partially threaded with a thread pitch of 0.5 to 3.0 mm, said longitudinal body portion having a threaded diameter ranging from 1 to 8 mm and a core diameter range from 1 to 8 mm, said longitudinal body portion having at least one aperture perpendicular to said longitudinal body portion with a configuration sufficient to accommodate at least one suture, said aperture being below said head portion and above the first thread.

59. The fixation device of claim 23 wherein said head portion being cylindrical with only two flat sides.

60. The fixation device of claim 23 wherein said head portion being cylindrical with only three flat sides.

61. The fixation device of claim 23 wherein said head portion has at least one aperture, wherein at least one of said apertures of said head portion is parallel to the longitudinal body portion and is of a configuration sufficient to accommodate at least one suture.

62. The fixation device of claim 23 wherein said longitudinal body portion having a plurality of perforations.

63. The fixation device of claim 62 wherein said perforations piercing the surface of said longitudinal body and not extending through said longitudinal body.

26. A fixation device formed in the shape of a screw, said fixation device made of human or animal cortical bone, said fixation device being grafted into a biologically active structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) two end portions, at least one of said end portions being adapted to provide rotational movement to said fixation device;

b) said end portions being fixedly attached to a longitudinal body portion;

c) one of said end portions formed in the shape of a cylindrical screw head and having an indentation, said indentation being perpendicular to said longitudinal body portion, said indentation being shaped to receive a rotational tool; and

d) said longitudinal body portion being at least partially threaded with a thread pitch of 0.5 to 3.0, said longitudinal body portion having a thread diameter ranging from 1 to 8 mm and a core diameter range from 1 to 8 mm.

27. The fixation device of claim 26 wherein said fixation device has an aperture extending along the entire longitudinal axis, said aperture having a configuration sufficient to allow the insertion of a pin.

28. The fixation device of claim 26 wherein said fixation device has an aperture extending along the entire longitudinal axis, said aperture having a configuration sufficient to allow the insertion of a wire.

29. The fixation device of claim 26 wherein said indentation being shaped to receive a Philip'"'"'s head rotational tool.

30. The fixation device of claim 26 wherein said indentation being shaped in the form of a cruciform recess.

31. The fixation device of claim 26 wherein said fixation device has a length of 1 to 10 cm.

32. The fixation device of claim 26 wherein said fixation device having a plurality of perforations on said longitudinal body portion.

64. The fixation device of claim 26 wherein said longitudinal body portion having at least one aperture perpendicular to said longitudinal body portion, said head portion having at least one aperture, wherein at least one of said apertures of said head portion is parallel to the longitudinal body portion and is of a configuration sufficient to accommodate at least one suture.

65. The fixation device of claim 32 wherein said perforations piercing the surface of said longitudinal body and not extending through said longitudinal body.

33. A fixation device formed in the shape of a screw, said fixation device being adapted to be grafted into a biologically active structure, said fixation device being interactive with said structure and forming a part of said structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) two end portions, at least one of said end portions being able to receive a rotational tool to provide rotational movement to said fixation device;

b) said end portions being fixedly attached to a longitudinal body portion; and

c) said longitudinal body portion, wherein said longitudinal body portion has an aperture extending along the entirety of said longitudinal body portion, said aperture having a configuration sufficient to allow the insertion of a pin, said longitudinal body portion having threads extending from a region above one of said end portions to a region below other said end portion.

34. A fixation device formed in the shape of a screw, said fixation device being made of human or animal cortical bone tissue, said fixation device being able to be grafted into a biologically active structure, said fixation device becoming a part of said structure and need not be removed from said biologically active structure, said fixation device comprising:

a) two end portions, at least one of said end portions being able to receive a rotational tool to provide rotational movement to said fixation device, at least one of said ends being cylindrical and having only two flat sides;

b) said end portions being fixedly attached to a longitudinal body portion; and

c) said longitudinal body portion which has an aperture extending along the entirety of said longitudinal body portion, said aperture having a configuration sufficient to allow the insertion of a pin, said longitudinal body portion having threads extending from a region about one of said ends to a region below other said end, wherein the thread diameter is about 3.0 mm, the thread pitch is about 1.25, and the core diameter is about 1.9 mm.

35. A method of making said fixation device of claim 34 comprising machining human or animal cortical bone tissue into the shape of a screw under conditions that do not allow the surface temperature at which bone tissue is burned or damaged and that allow said fixation device to be sterilized sufficiently to be acceptable to use in the fixation of living bone.

36. The method of claim 35 wherein said bone tissue is sterile prior to machining, the machining is carried out using a cooling lubricant, and said fixation device is sterilized after completion.

66. The fixation device of claim 34 wherein said head portion being cylindrical with three flat sides.

37. A fixation device in the shape of a pin, said fixation device made of human or animal cortical bone, said fixation device being adapted to be grafted into a biologically active structure, said fixation device being interactive with said structure and forming a part of said structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) two end portions being fixedly attached to a longitudinal body portion;

b) said longitudinal body portion including a means for fixedly retaining at least a portion of said longitudinal body portion in said biologically active structure; and

c) said longitudinal body portion is elliptical.

38. A fixation device in the shape of a pin, said fixation device made of human or animal cortical bone, said fixation device being adapted to be grafted into a biologically active structure, said fixation device being interactive with said structure and forming a part of said structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) two end portions being fixedly attached to a longitudinal body portion;

b) said longitudinal body portion including a means for fixedly retaining at least a portion of said longitudinal body portion in said biologically active structure; and

c) said longitudinal body portion having a plurality of barbs extending from a region above one of said end portions to a region below other said end portion.

39. A fixation device in the form of an screw adapted to be grafted into a biologically active structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device comprising:

a) a head portion functionally adapted to provide rotational movement to said fixation device, said head portion having at least one aperture extending through the width of said head portion;

b) said head portion being fixedly attached to a longitudinal body portion; and

c) said longitudinal body portion being at least partially threaded.

40. The fixation device of claim 39 wherein said head portion is adapted to receive a rotational tool.

41. The fixation device of claim 39 wherein said head portion has at least two flat sides.

42. The fixation device of claim 39 wherein said fixation device is made of human or animal cortical bone tissue.

43. The fixation device of claim 39 wherein said fixation device is inserted into human or animal bone tissue.

44. The fixation device of claim 39 wherein said fixation device is not biologically toxic.

45. The fixation device of claim 39 wherein said fixation device is non-metallic.

46. The fixation device of claim 39 wherein said fixation device having a plurality of perforations on said longitudinal body portion.

67. The fixation device of claim 39 wherein said head portion being cylindrical with only two flat sides.

68. The fixation device of claim 39 wherein said head portion being cylindrical with only three flat sides.

69. The fixation device of claim 46 wherein said perforations piercing the surface of said longitudinal body and not extending through said longitudinal body.

47. A fixation device adapted to be grafted into a biologically active structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device made of human or animal cortical bone, said fixation device comprising:

a) a plate having a series of holes; and

b) said plate is in the shape of an oblique-L.

48. A fixation device adapted to be grafted into a biologically active structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device made of human or animal cortical bone, said fixation device comprising:

a) a plate having a series of holes; and

b) said plate is in the shape of a small-T.

49. A fixation device adapted to be grafted into a biologically active structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device made of human or animal cortical bone, said fixation device comprising:

a) a plate having a series of holes; and

b) said plate is in the shape of a clover leaf.

70. A fixation device adapted to be grafted into a biologically active structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device made of human or animal cortical bone, said fixation device comprising:

a) a plate having a series of holes; and

b) said human or animal cortical bone is mineralized.

71. A method of making a fixation device in the shape of a pin, said fixation device made of human or animal cortical bone tissue, said fixation device being adapted to be grafted into a biologically active structure, said fixation device being interactive with said structure and forming a part of said structure, said fixation device being compatible with the functional characteristics of said structure, said fixation device having two end portions being fixedly attached to a longitudinal body portion, said longitudinal body portion including a means for fixedly retaining at least a portion of said longitudinal body portion in said biologically active structure, the method comprising:

a) sterilizing said human or animal cortical bone tissue;

b) machining said human or animal cortical bone tissue into the shape of a pin with a cooling lubricant under conditions that do not allow the surface temperature at which bone tissue is burned or damaged and that allow said fixation device to be sterilized sufficiently to be acceptable to use in the fixation of living bone;

c) sterilizing the fixation device after said machining.