Polyaxial screw

• US 8,894,691 B2
• Filed: 05/03/2013
• Issued: 11/25/2014
• Est. Priority Date: 04/08/2004
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: Iott, Andrew, Lee, Andrew, Binder, Larry, Paul, David C.
• Primary Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US13/887,098
• Publication Number:
  US 20140058452A1
• Time in Patent Office: 571 Days
• Field of Search: 606/60, 606/70, 606/71, 606246-279, 606300-331
• US Class Current: 606/267
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7035 Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
• CPC Class Codes: A61B 17/7037 wherein pivoting is blocked when the rod is clamped

Abstract

The present invention generally is directed toward a spinal fixation system whereby a coupling element allows the physician to selectively lock or unlock either the connection between the coupling element and a fastener, such as to allow for repositioning of the coupling element, or the connection between the coupling element and an elongate rod. The locking or unlocking of these connections may be made independently and as desired by the physician.

Claims

1. A spinal stabilization system comprising:

a fastener member including a head and a shaft, wherein the shaft extends along a longitudinal axis from the head and at least a portion of the shaft includes a thread, wherein at least a portion of the head comprises a rounded surface and a recess formed through a top of the head capable of receiving a driving tool;

a coupling element for receiving the fastener, the coupling element comprising a lower portion and an upper portion, the lower portion including a clamp element having a lower clamp portion, wherein the lower clamp portion has an inner surface that clamps around at least a portion of an outer surface of the head, wherein the upper portion of the coupling element includes a first arm and a second arm opposing the first arm, wherein a first channel is formed between the first and second arms for passing a rod member therethrough, wherein the first arm includes a first exterior sidewall and the second arm includes a second exterior sidewall, wherein each of the first and second exterior sidewalk has a first axis that extends substantially in a direction from a top of the coupling element to a bottom of the coupling element, wherein an engagement channel is formed along a second axis substantially transverse to the first axis in each of the first and second exterior sidewalk, wherein the engagement channel comprises an upper boundary and a lower boundary, wherein the upper boundary of the engagement channel comprises a first planar portion, a second planar portion and a curved portion located between the first and second planar portions, the planar portions and the curved portion define a portion of the engagement channel within each of the first and second exterior sidewalls;

a rod member received in the first channel between the first and second arms, wherein the rod member is capable of being seated in the first channel, wherein the rod member includes a first end and a second end and a generally cylindrical body between the first end and the second end that is received in the first channel; and

a locking cap attachable to the coupling element, the locking cap comprising an upper surface and a lower surface that faces the rod member.

2. The spinal stabilization system of claim 1, wherein at least one of the first exterior sidewall of the first arm and the second exterior sidewall of the second arm further include a hole, wherein the hole is a blind hole such that the hole is formed through the at least one of the first and second exterior sidewalk of at least one of the first and second arms but does not extend into an inner surface of the at least one of the first and second arms.

3. The spinal stabilization system of claim 1, wherein the recessed channel is configured and dimensioned to receive a tool for reducing the rod member.

4. The spinal stabilization system of claim 1, wherein the curved portion of the upper boundary of the engagement channel comprises a semicircular portion that partially encloses a semicircular area within each of the first and second exterior sidewalls.

5. The spinal stabilization system of claim 1, wherein the lower boundary of the engagement channel has a first planar portion and a second planar portion.

6. The spinal stabilization system of claim 1, wherein at least a portion of the upper boundary of the engagement channel is at an angle relative to the second axis.

7. The spinal stabilization system of claim 1, wherein at least a portion of the lower boundary of the engagement channel is at an angle relative to the second axis.

8. The spinal stabilization system of claim 1, wherein at least one of the first exterior sidewall of the first arm and the second exterior sidewall of the second arm includes a recessed engagement area proximate the first channel for receiving a tool.

9. A spinal stabilization system comprising:

a fastener member including a head portion and a shaft portion, wherein the shaft portion extends from the head portion, wherein at least a portion of the head portion comprises a rounded surface;

a coupling element for receiving the fastener member, the coupling element comprising a lower portion and an upper portion, wherein the upper portion of the coupling element includes a first extension and a second extension opposing the first extension, wherein a channel is formed between a first inner surface of the first extension and a second inner surface of the second extension for passing a rod member therethrough, wherein the first extension includes a first end and a second end and a first exterior sidewall formed between the first end and the second end, wherein the second extension includes a third end and a fourth end and a second exterior sidewall formed between the third end and the fourth end, wherein the first exterior sidewall has a first axis that extends substantially in a direction from a top of the coupling element to a bottom of the coupling element, wherein an engagement channel is formed along a second axis substantially transverse to the first axis in the first exterior sidewall, wherein the engagement channel comprises a recessed channel having an upper boundary and a lower boundary, wherein a distance between the upper boundary and the lower boundary changes along a length of the channel such that (1) at a first point along the second axis that is closer to the first end than a second point along the second axis, the distance between the upper boundary and lower boundary is greater at the first point than the second point and (2) at a third point along the second axis that is farther from the first end than the second point along the second axis, the distance between the upper boundary and the lower boundary is greater than at the second point;

a rod member received in the channel between the first and second extensions, wherein the rod member includes a proximal end and a distal end and a cylindrical body between the proximal end and the distal end that is capable of being received in the channel; and

a locking cap attachable to the coupling element, the locking cap comprising an upper surface and a lower surface that faces the rod member.

10. The spinal stabilization system of claim 9, wherein at least one of the first, second, third and fourth ends includes a recessed engagement area proximate the first channel for receiving a tool.

11. The spinal stabilization system of claim 9, wherein at least one of the first and second extensions further include a hole, wherein the hole is a blind hole such that the hole is formed through the exterior sidewall of at least one of the first and second extensions but does not extend into an inner surface of the at least one of the first and second extensions.

12. The spinal stabilization system of claim 9, wherein at least a portion of the engagement channel in the first exterior sidewall comprises a curved portion.

13. The spinal stabilization system of claim 12, wherein the curved portion of the engagement channel comprises a semicircular portion that partially encloses a semicircular recessed area.

14. The spinal stabilization system of claim 12, wherein the curved portion of the recessed channel is configured and dimensioned to receive a tool for reducing the rod member.

15. A spinal stabilization system comprising:

a fastener member including a head and a shaft, wherein the shaft extends along a longitudinal axis from the head, wherein at least a portion of the shaft is threaded, wherein at least a portion of the head comprises a rounded surface;

a coupling element for receiving the fastener member, the coupling element comprising a lower portion and an upper portion, wherein the upper portion of the coupling element includes a first extension and a second extension opposing the first extension, wherein a channel is formed between a first inner surface of the first extension and a second inner surface of the second extension for passing a rod member therethrough, wherein the first and second extensions each include an exterior sidewall, wherein the exterior sidewall has a first axis that extends substantially in a direction from a top of the coupling element to a bottom of the coupling element, wherein an engagement channel is formed along a second axis substantially transverse to the first axis, wherein the engagement channel comprises a channel having an upper boundary and a lower boundary that is recessed within the exterior sidewall, wherein the upper boundary of the engagement channel comprises an arcuate portion that partially encloses a recessed area, wherein each of the first and second extensions further includes a hole formed along a third axis substantially transverse to the first axis, wherein the hole is a blind hole such that the hole is formed through the exterior sidewall of each of the first and second extensions but does not extend into the inner surfaces of the first and second extensions,

a rod member passed through the channel between the first and second extensions, wherein the rod member includes a first end and a second end and a cylindrical body between the first end and the second end that is capable of being received in the channel; and

a locking cap attachable to the coupling element, the locking cap comprising an upper surface and a lower surface that faces the rod member.

16. The spine stabilization system of claim 15, wherein at least a portion of the upper boundary of the engagement channel is cut at an angle relative to the second axis.

17. The spine stabilization system of claim 15, wherein at least a portion of the lower boundary is cut at an angle relative to the second axis.

18. The spine stabilization system of claim 15, wherein the arcuate portion of the recessed area provides an engagement area for a tool.

19. The spine stabilization system of claim 15, wherein the coupling element comprises a first downwardly tapering surface that extends between the lower boundary of the first extension and a bottom of the coupling element and a second downwardly tapering surface that extends between the lower boundary of the second extension and the bottom of the coupling element.

20. The spine stabilization system of claim 15, wherein at least one of the exterior sidewalls of the first arm and the second arm includes a recessed engagement area proximate the channel for receiving a tool.

21. The spine stabilization system of claim 15, wherein the upper boundary of the engagement channel comprises a first planar portion and a second planar portion, wherein the arcuate portion is positioned between the first and second planar portions.

22. A spinal stabilization system comprising:

a fastener member including a head, wherein the fastener member is configured to engage a bone member;

a coupling element for receiving the fastener member, the coupling element comprising a lower portion and an upper portion, wherein the upper portion of the coupling element includes a first extension and a second extension opposing the first extension, wherein a channel is formed between a first inner surface of the first extension and a second inner surface of the second extension for passing an elongate member therethrough, wherein the first and second extensions each include an exterior sidewall, wherein the exterior sidewall has a first axis that extends substantially in a direction from a top of the coupling element to a bottom of the coupling element, wherein an engagement channel is formed along a second axis substantially transverse to the first axis, wherein the engagement channel comprises a channel having an upper boundary and a lower boundary that is recessed within the exterior sidewall, wherein the upper boundary of the engagement channel comprises an arcuate portion that partially encloses a recessed area, wherein each of the first and second extensions further includes a hole formed along a third axis substantially transverse to the first axis, wherein the hole is a blind hole such that the hole is formed through the exterior sidewall of each of the first and second extensions but does not extend into the inner surfaces of the first and second extensions,

an elongate member passed through the channel between the first and second extensions, wherein the elongate member includes a first end and a second end and a body between the first end and the second end that is capable of being received in the channel; and

a locking cap attachable to the coupling element, the locking cap comprising an upper surface and a lower surface that faces the rod member.

23. The spinal stabilization system of claim 22, wherein the fastener member comprises a screw.

24. The spinal stabilization system of claim 23, wherein the screw is capable of polyaxial movement with respect to the coupling element.

25. The spinal stabilization system of claim 23, further comprising at least one hook member accompanied by the fastener member.

26. The spinal stabilization system of claim 22, wherein the fastener member comprises a hook member.

27. The spinal stabilization system of claim 22, wherein the elongate member comprises a flexible member.

28. The spinal stabilization system of claim 27, wherein the flexible member assists in non-rigid immobilization of at least a portion of a spine.

29. The spinal stabilization system of claim 22, further comprising at least one of a positioning device, minimally invasive system tool, holding apparatus or aligning device for engaging with the engagement channel.

30. The spine stabilization system of claim 22, wherein at least one of the exterior sidewalls of the first arm and the second arm includes a recessed engagement area proximate the channel for receiving a tool.

31. The spine stabilization system of claim 30, wherein the recessed engagement area is on a first face of each of the first and second extensions and the engagement channel is on a second face of each of the first and second extensions.

32. A spinal stabilization system comprising:

a fastener member including ahead, wherein the fastener member is configured to engage a bone member;

a coupling element for receiving the fastener member, the coupling element comprising a lower portion and an upper portion, the lower portion including a clamp element that engages the head of the fastener member, wherein the fastener is capable of polyaxial movement relative to the coupling element until a downward force is applied to the clamp element, wherein the upper portion of the coupling element includes a first extension and a second extension opposing the first extension, wherein a channel is formed between a first inner surface of the first extension and a second inner surface of the second extension for passing an elongate member therethrough, wherein the first and second extensions each include a first exterior surface and a second exterior surface, wherein the first exterior surface has a first axis that extends substantially in a direction from a top of the coupling element to a bottom of the coupling element, wherein an engagement channel is formed along a second axis substantially transverse to the first axis, wherein the engagement channel comprises a channel having an upper boundary and a lower boundary that is recessed within the first exterior surface, wherein the upper boundary of the engagement channel comprises an arcuate portion that partially encloses a recessed area within the first exterior surface, wherein the second exterior surface includes a recessed engagement area;

an elongate member passed through the channel between the first and second extensions, wherein the elongate member includes a first end and a second end and a body between the first end and the second end that is capable of being received in the channel; and

a locking cap attachable to the coupling element, the locking cap comprising an upper surface and a lower surface that faces the rod member.

33. The spinal stabilization system of claim 32, wherein the fastener member comprises a screw.

34. The spinal stabilization system of claim 32, wherein the fastener member comprises a laminar hook.

35. The spinal stabilization system of claim 32, wherein the recessed engagement area is independent from the engagement channel.

36. The spinal stabilization system of claim 32, wherein the elongate member comprises a flexible member.

37. The spinal stabilization system of claim 32, further comprising a hole formed along a third axis substantially transverse to the first axis, wherein the hole is a blind hole such that the hole is formed through the first exterior surface of each of the first and second extensions but does not extend into the inner surfaces of the first and second extensions.

38. A spinal stabilization system comprising:

a fastener member including a head portion and a shaft portion, wherein the shaft portion extends from the head portion, wherein at least a portion of the head portion comprises a rounded surface;

a coupling element for receiving the fastener member, the coupling element comprising a lower portion and an upper portion, wherein the upper portion of the coupling element includes a first extension and a second extension opposing the first extension, wherein a channel is formed between a first inner surface of the first extension and a second inner surface of the second extension for passing a rod member therethrough, wherein the first extension includes a first end and a second end and a first exterior sidewall formed between the first end and the second end, wherein the second extension includes a third end and a fourth end and a second exterior sidewall formed between the third end and the fourth end, wherein the first exterior sidewall has a first axis that extends substantially in a direction from a top of the coupling element to a bottom of the coupling element, wherein an engagement channel is formed along a second axis substantially transverse to the first axis in the first exterior sidewall, wherein the engagement channel comprises a recessed channel having an upper boundary and a lower boundary, wherein a distance between the upper boundary and the lower boundary changes along a length of the channel such that at a first point along the second axis that is closer to the first end than a second point along the second axis, the distance between the upper boundary and lower boundary is greater at the first point than the second point;

a rod member received in the channel between the first and second extensions, wherein the rod member includes a proximal end and a distal end and a cylindrical body between the proximal end and the distal end that is capable of being received in the channel; and

a locking cap attachable to the coupling element, the locking cap comprising an upper surface and a lower surface that faces the rod member.

39. The spinal stabilization system of claim 38, wherein the first extension further comprises a recessed engagement area independent from the engagement channel.

40. The spinal stabilization system of claim 38, wherein the first extension further comprises a hole formed along a third axis substantially transverse to the first axis, wherein the hole is a blind hole such that the hole is formed through the first exterior sidewall of the first extension but does not extend into the inner surface of the first extension.

41. The spinal stabilization system of claim 38, further comprising at least one of a positioning device, minimally invasive system tool, holding apparatus or aligning device for engaging with the engagement channel.