Spine distraction implant and method

• US 8,821,548 B2
• Filed: 04/27/2007
• Issued: 09/02/2014
• Est. Priority Date: 01/02/1997
• Status: Expired due to Fees

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Zucherman, James F., Hsu, Ken Y., Fallin, T. Wade, Klyce, Henry A.
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US11/790,905
• Publication Number:
  US 20070203495A1
• Time in Patent Office: 2,685 Days
• Field of Search: 606/61, 606/86.A, 606/99, 606/249, 606/279, 606246-248, 623 1711- 1716
• US Class Current: 606/249
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
• CPC Class Codes: A61B 17/7071 Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen
• CPC Class Codes: Y10S 606/91 Polymer

Abstract

A spine distraction implant alleviates pain associated with spinal stenosis and facet arthropathy by expanding the volume in the spine canal and/or neural foramen. The implant provides a spinal extension stop while allowing freedom of spinal flexion.

Claims

1. An apparatus, comprising:

a first end unit having a first saddle configured to receive a first spinous process from adjacent spinous processes and a threaded outer surface;

a second end unit having a second saddle configured to receive a second spinous process from the adjacent spinous processes and an unthreaded outer surface;

an interbody unit disposed between the first end unit and the second end unit, the interbody unit defining a distance between the first saddle and the second saddle and having a first longitudinal axis;

each saddle having a concave shape that has a lowest point and an opening, the openings facing in opposite directions and generally along a second axis defined by and extending through the lowest points of the two saddles;

the first longitudinal axis being substantially coaxial with the second axis;

the interbody unit comprising an inner surface defining a bore comprising a threaded portion and an unthreaded portion, the threaded outer surface engaging threads of the threaded portion and the unthreaded outer surface engaging the unthreaded portion;

the first saddle having only two upwardly extending fork members and the second saddle having only two downwardly extending fork members, wherein each of the fork members has a substantially dull tip;

wherein when the apparatus is disposed between the first and second spinous processes, each saddle extends through a sagittal plane defined by the first and second spinous processes;

wherein the first and second end units are separate and distinct from one another.

2. The apparatus of claim 1, wherein the first end unit, the second end unit and the interbody unit are collectively configured as a spine extension stop.

3. The apparatus of claim 1, wherein the interbody unit has a substantially circular cross-section.

4. The apparatus of claim 1, wherein the interbody unit is coupled to the first end unit and the second end unit such that the first saddle is rotatable with respect to the second saddle.

5. The apparatus of claim 1, wherein the interbody unit is configured to maintain a distraction of least 5 mm between the first spinous process and the second spinous process.

6. The apparatus of claim 1, wherein the distance between the first saddle and the second saddle is increased when the interbody unit is rotated with respect to the first end unit.

7. The apparatus of claim 1, wherein the interbody unit is configured to maintain a distraction of at least 22 mm between the first spinous process and the second spinous process.

8. The apparatus of claim 1, wherein the interbody unit defines a plurality of holes configured to define, at least in part, a flexibility of the interbody unit.

9. The apparatus of claim 1, wherein threads of the threaded outer surface engage the threads of the threaded portion as the first end unit is rotated relative to the interbody unit to change the distance between the first saddle and the second saddle.

30. The apparatus of claim 1, wherein the first end unit has a substantially circular cross-section.

31. The apparatus of claim 1, wherein the first end unit has a circular cross-section within a plane normal to the first longitudinal axis.

32. The apparatus of claim 1, wherein:

the first end unit, the second end unit, and the interbody unit are collectively configured to allow movement of the first spinous process relative to the second spinous process in a first direction substantially parallel to the first longitudinal axis; and

the first end unit, the second end unit, and the interbody unit are collectively configured to limit movement of the first spinous process relative to the second spinous process in a second direction substantially parallel to the first longitudinal axis, the second direction opposite the first direction.

33. The apparatus of claim 1, wherein the first end unit is engaged with the interbody unit such that the first end unit can be rotated generally about the first longitudinal axis of the interbody unit when the interbody unit is disposed between the first spinous process and the second spinous process, and such that the first end unit can be moved relative to the interbody unit generally along the first longitudinal axis of the interbody unit.

34. The apparatus of claim 1, wherein the two fork members of the first saddle are spaced apart from each other by a width, the two fork members disposed substantially symmetrically about the first longitudinal axis, the first saddle having a thickness along a third axis extending substantially normal to the first longitudinal axis, the thickness greater than the width.

42. The apparatus of claim 1 wherein the first end unit, the second end unit, and the interbody unit are collectively configured as a spine flexion non-inhibitor.

44. The apparatus of claim 1 wherein each of the first and second end units and the interbody unit has a cross-sectional profile in a plane normal to the first longitudinal axis, and wherein when the cross-sectional profiles are projected onto a common plane normal to the first longitudinal axis the profile of the interbody unit does not extend beyond the profile of at least one of the end units.

48. The apparatus of claim 1 wherein when the apparatus is disposed between the first and second spinous processes, the apparatus is symmetric about the sagittal plane.

52. The apparatus of claim 1 wherein an inner surface of the second end unit defines an unthreaded cavity having an end of the first end unit disposed therein.

53. The apparatus of claim 1 wherein a cross hole extends through opposite sides of the threaded portion.

10. An apparatus, comprising:

a first end unit having a first saddle configured to receive a first spinous process from adjacent spinous processes and an unthreaded outer surface, the saddle of the first end unit including a first fork member and a second fork member disposed apart from the first fork member, the first fork member and the second fork member disposed substantially symmetrically about a longitudinal axis of an interbody unit that is disposed between the first end unit and a second end unit;

the second end unit having a second saddle configured to receive a second spinous process from the adjacent spinous processes and a threaded outer surface, the saddle of the second end unit including a first fork member and a second fork member disposed apart from the first fork member of the second end unit, the first fork member of the second end unit and the second fork member of the second end unit disposed substantially symmetrically about the longitudinal axis of the interbody unit;

the first and second saddles having only two fork members, wherein each of the fork members has a substantially dull tip;

the interbody unit comprising an inner surface defining a bore comprising a threaded portion and an unthreaded portion, the threaded outer surface engaging threads of the threaded portion and the first end unit being slidably disposed in the unthreaded portion such that the first saddle is moveable relative to the second saddle, the interbody unit defining a distance between the first saddle and the second saddle;

wherein the first end unit is removably coupled relative to the second end unit.

11. The apparatus of claim 10, wherein the first end unit, the second end unit and the interbody unit are collectively configured as a spine flexion non-inhibitor.

12. The apparatus of claim 10, wherein the interbody unit has a substantially circular cross-section.

13. The apparatus of claim 10, wherein the interbody unit is coupled to the first end unit and the second end unit such that the first saddle is rotatable with respect to the second saddle.

14. The apparatus of claim 10, wherein the unthreaded outer surface engages the unthreaded portion of the bore.

15. The apparatus of claim 10, wherein the threaded outer surface engages the threads of the threaded portion as the second end unit is rotated relative to the interbody unit to change the distance between the first saddle and the second saddle.

35. The apparatus of claim 10, wherein:

the first end unit, the second end unit, and the interbody unit are collectively configured to allow movement of the first spinous process away from the second spinous process; and

the first end unit, the second end unit, and the interbody unit are collectively configured to limit movement of the first spinous process towards the second spinous process.

36. The apparatus of claim 10, wherein:

the interbody unit is coupled to the first end unit such that the second end unit can be rotated generally about the longitudinal axis of the interbody unit when the interbody unit is disposed between the first spinous process and the second spinous process, and such that the second end unit can be moved relative to the interbody unit generally along the longitudinal axis of the interbody unit.

37. The apparatus of claim 10, wherein the first and second fork members of the first end unit are spaced a width apart, and the saddle of the first end unit has a thickness along an axis substantially normal to the longitudinal axis that is greater than the width.

38. The apparatus of claim 10, wherein:

the saddle of the first end unit has a substantially circular cross-section having an outer diameter; and

the interbody unit has a substantially circular cross-section having an outer diameter,

the outer diameter of the first end unit being substantially equal to the outer diameter of the interbody unit.

43. The apparatus of claim 10 wherein the first end unit, the second end unit, and the interbody unit are collectively configured as a spine extension stop.

45. The apparatus of claim 10 wherein each of the first and second end units and the interbody unit has a cross-sectional profile in a plane normal to the longitudinal axis, and wherein when the cross-sectional profiles are projected onto a common parallel plane the profile of the interbody unit does not extend beyond the profile of at least one of the end units.

49. The apparatus of claim 10 wherein when the apparatus is disposed between the first and second spinous processes, the apparatus is symmetric about a sagittal plane defined by the first and second spinous processes.

16. An apparatus, comprising:

an implant configured to be disposed between adjacent spinous processes of a spinal column, the implant including;

a first forked end unit comprising an unthreaded outer surface and defining a first saddle configured to receive a first spinous process from the adjacent spinous processes;

a second forked end unit comprising a threaded outer surface and defining a second saddle configured to receive a second spinous process from the adjacent spinous processes;

an interbody unit disposed between the first forked end unit and the second forked end unit, the interbody unit defining a distance between a portion of the first saddle and a portion of the second saddle;

the first saddle defining an opening facing outwardly from the interbody unit in a first direction substantially parallel to a first longitudinal axis of the interbody unit, the second saddle defining an opening facing outwardly from the interbody unit in a second direction substantially parallel to the first longitudinal axis of the interbody unit, the second direction opposite the first direction;

the first saddle including a first fork member and a second fork member spaced a width apart from the first fork member, the first fork member and the second fork member disposed substantially symmetrically about the first longitudinal axis, the first saddle having a thickness along a second axis substantially normal to the first longitudinal axis, the thickness greater than the width;

the interbody unit comprising an inner surface defining a bore comprising a threaded portion and an unthreaded portion, the threaded outer surface engaging the threaded portion and the unthreaded outer surface being disposed in the unthreaded portion;

wherein the first and second forked ends are separate and distinct from one another;

the first saddle having only two fork members, wherein each of the fork members has a substantially dull tip.

17. The apparatus of claim 16, wherein the unthreaded outer surface engages the unthreaded portion of the bore such that the first forked end unit is slidably disposed in the unthreaded portion.

18. The apparatus of claim 16, wherein the implant is configured as a spine extension stop, and the implant is configured as a spine flexion non-inhibitor.

19. The apparatus of claim 16, wherein the interbody unit has a substantially circular cross-section.

20. The apparatus of claim 16, wherein the interbody unit is coupled to the first forked end unit and the second forked end unit such that the first saddle is rotatable with respect to the second saddle.

21. The apparatus of claim 16, wherein the implant is configured to distract the first spinous process and the second spinous process for at least 5 mm.

22. The apparatus of claim 16, wherein the distance between the portion of the first saddle and the portion of the second saddle is increased when the interbody unit is rotated with respect to the second forked end unit.

23. The apparatus of claim 16, wherein the threaded outer surface engages the threads of the threaded portion as the second end unit is rotated relative to the interbody unit to change the distance between the portion of the first saddle and the portion of the second saddle.

39. The apparatus of claim 16, wherein:

the first saddle has a circular cross-section within a plane normal to the first longitudinal axis of the interbody unit.

40. The apparatus of claim 16, wherein:

the first saddle has a substantially circular cross-section having an outer diameter; and

the interbody unit has a substantially circular cross-section having an outer diameter, the outer diameter of the first end unit being substantially equal to the outer diameter of the interbody unit.

46. The apparatus of claim 16 wherein the first forked end unit and the interbody unit each has a cross-sectional profile in a plane normal to the first longitudinal axis, and wherein when the cross-sectional profiles are projected onto a common parallel plane the profile of the interbody unit does not extend beyond the profile of the end unit.

50. The apparatus of claim 16 wherein when the apparatus is disposed between the first and second spinous processes, the apparatus is symmetric about a sagittal plane defined by the first and second spinous processes.

24. An apparatus, comprising:

a spacer having a first saddle configured to receive a first spinous process and having a second saddle configured to receive a second spinous process adjacent to the first spinous process, the first saddle comprising a threaded outer surface and the second saddle comprising an unthreaded outer surface,

the first saddle having a substantially circular cross-section having an outer diameter and defining a first center line,

the second saddle having a substantially circular cross-section having an outer diameter and defining a second center line,

the outer diameter of the first saddle substantially equal to the outer diameter of the second saddle, the second center line substantially coaxial with the first center line;

a central body disposed between the first saddle and the second saddle, the central body having a central longitudinal axis that extends through the first and second saddles;

wherein the central body comprises an inner surface defining a bore comprising a threaded portion and an unthreaded portion, the threaded outer surface engaging the threaded portion and the unthreaded outer surface engaging the unthreaded portion;

the first saddle having only two upwardly extending fork members and the second saddle having only two downwardly extending fork members, wherein each of the fork members has a substantially dull tip.

25. The apparatus of claim 24, wherein the first saddle and the second saddle are configured such that the first saddle can be rotated with respect to the second saddle.

26. The apparatus of claim 24, wherein the central body is disposed between the first saddle and the second saddle such that each of the saddles can be rotated with respect to the other saddle.

27. The apparatus of claim 24, wherein the spacer is configured as a spine flexion non-inhibitor.

28. The apparatus of claim 24, wherein the threaded outer surface engages threads of the threaded portion as the first saddle is rotated relative to the central to change the distance between the first saddle and the second saddle.

29. The apparatus of claim 24, wherein a distance between the first saddle and the second saddle is changed when the first saddle is rotated with respect to the second saddle.

41. The apparatus of claim 24, wherein the two fork members of the first saddle are spaced a width apart from each other, the two fork members of the first saddle being disposed substantially symmetrically about the first center line, the outer diameter of the first saddle being greater than the width.

47. The apparatus of claim 26 wherein the first saddle and central body each has a cross-sectional profile in a plane normal to the first and second center lines, and wherein when the cross-sectional profiles are projected onto a common parallel plane the profile of the central body unit does not extend beyond the profile of the first saddle.

51. The apparatus of claim 24 wherein when the apparatus is disposed between the first and second spinous processes, the apparatus is symmetric about a sagittal plane defined by the first and second spinous processes.