Surgical instrumentation and method for treatment of the spine

• US 6,676,665 B2
• Filed: 08/13/2001
• Issued: 01/13/2004
• Est. Priority Date: 08/11/2000
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Foley, Kevin T., Justis, Jeff R.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/928,949
• Publication Number:
  US 20020026197A1
• Time in Patent Office: 883 Days
• Field of Search: 606/53, 606/76, 606/78, 606/86, 606/105, 606/191, 606/198, 600/201, 600/210, 600/235
• US Class Current: 606/105
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity

Abstract

Instrumentation for treatment of the spine, including an elongate member having a deformable distal end portion at least partially formed of a flexible and preferably elastic material. The distal end portion has an initial configuration for placement adjacent a vertebral body and a deformed configuration defining at least one outwardly extending projection for displacement of at least a portion of the vertebral body. The elongate member preferably comprises a rod member, a sleeve member and an actuator mechanism for imparting relative linear displacement between the rod and sleeve members to effect outward deformation of the distal end portion of the sleeve member. In one embodiment, the instrumentation is used to compact cancellous bone to form a cavity within a vertebral body. In another embodiment, the instrumentation is used to reduce a compression fracture. In yet another embodiment, the instrumentation is used to distract a disc space between adjacent vertebral bodies.

Claims

1. Instrumentation for treatment of the spine, comprising:

an elongate member extending along a longitudinal axis and including a deformable distal end portion having an initial configuration for placement adjacent a spinal structure and a deformed configuration defining at least one transverse projection for transverse displacement of at least a portion of the spinal structure, each of said at least one transverse projection disposed along a single transverse axis such that said transverse displacement of the spinal structure is uniaxial.

2. The instrumentation of claim 1, wherein said transverse displacement of the spinal structure is directionally-controlled.

3. The instrumentation of claim 1, wherein said transverse displacement of the spinal structure is unidirectional.

4. The instrumentation of claim 1, wherein said deformed configuration defines a plurality of said transverse projections.

5. The instrumentation of claim 4, wherein said deformed configuration defines a pair of said transverse projections disposed generally opposite one another.

6. The instrumentation of claim 1, wherein said deformed configuration results from a mechanically induced force.

7. The instrumentation of claim 6, wherein said deformable distal end portion comprises a first member and a second member engaged with said first member;

and

wherein said second member is reformed from said initial configuration toward said deformed configuration by relative displacement between said first and second members.

8. The instrumentation of claim 7, wherein said relative displacement between said first member and said second member is relative linear displacement.

9. The instrumentation of claim 7, further comprising an actuator mechanism operably coupled to said first and second members to impart said relative displacement therebetween.

10. The instrumentation of claim 1, wherein said deformable distal end portion is at least partially formed of a relatively flexible material.

11. The instrumentation of claim 10, wherein said deformable distal end portion is at least partially formed of a relatively elastic material.

12. The instrumentation of claim 11, wherein said relatively elastic material is a shape-memory material.

13. The instrumentation of claim 11, wherein said deformable distal end portion is reformed from said initial configuration toward said deformed configuration in response to the imposition of stress, and is reformed toward said initial configuration upon removal of said stress.

14. The instrumentation of claim 1, wherein said transverse displacement comprises intrabody distraction of a vertebral body.

15. The instrumentation of claim 14, wherein said intrabody distraction comprises compaction of cancellous bone to form a cavity within the vertebral body.

16. The instrumentation of claim 14, wherein said intrabody distraction comprises at least partial reduction of a compression fracture in the vertebral body.

17. The instrumentation of claim 1, wherein said transverse displacement comprises interbody distraction of a vertebral body.

18. The instrumentation of claim 1, wherein said initial configuration is sized to pass through an access opening in the spinal structure having a diameter within a range of about 1 millimeter to about 5 millimeters;

and

wherein said deformed configuration is sized to transversely displace the spinal structure within a range of about 3 millimeters to about 15 millimeters.

19. Instrumentation for treatment of the spine, comprising:

a first member;

a second member having a distal end portion engaged with said first member, said distal end portion having an initial configuration for placement adjacent a spinal structure and an expanded configuration for displacement of at least a portion of the spinal structure; and

wherein relative displacement between said first and second members causes said distal end portion to reform from said initial configuration toward said expanded configuration, said expanded configuration defining at least one transverse projection, each of said at least one transverse projection disposed along a single transverse axis such that said displacement of the spinal structure is uniaxial.

20. The instrumentation of claim 19, further comprising an actuator mechanism coupled between said first and second members and being operable to impart said relative displacement therebetween.

21. The instrumentation of claim 20, wherein said actuator mechanism is operable to reform said distal end portion of said second member from said expanded configuration back toward said initial configuration.

22. The instrumentation of claim 20, wherein said actuator mechanism comprises:

a first portion coupled to said first member; and

a second portion coupled to said second member and engaged with said first portion; and

wherein relative rotation between said first and second portions imparts relative linear displacement between said first and second members to cause said distal end portion to reform from said initial configuration toward said expanded configuration.

23. The instrumentation of claim 22, wherein said first portion of said actuator mechanism comprises a T-handle.

24. The instrumentation of claim 19, wherein said distal end portion of said second member is at least partially formed of a relatively elastic material to facilitate reformation from said initial configuration to said expanded configuration and back toward said initial configuration.

25. The instrumentation of claim 19, wherein said at least one transverse projection comprises an outward deformation.

26. The instrumentation of claim 25, wherein said distal end portion of said second member includes a pair of said outward deformations positioned generally opposite one another when in said expanded configuration.

27. The instrumentation of claim 19, wherein said distal end portion of said second member comprises at least one flexible strip of material, said flexible strip of material buckling outwardly in response to said relative displacement between said first and second members to form said at least one transverse projection.

28. The instrumentation of claim 27, wherein outward buckling of said flexible strip of material occurs in a predetermined direction.

29. The instrumentation of claim 27, wherein said distal end portion of said second member comprises a pair of said flexible strips of material disposed generally opposite one another, said flexible strips of material buckling outwardly in response to said relative displacement between said first and second members to form a pair of said at least one transverse projections disposed generally opposite one another.

30. The instrumentation of claim 27, wherein said flexible strip of material has a predetermined shape to provide controlled outward buckling.

31. The instrumentation of claim 19, wherein said distal end portion of said second member defines a plurality of slots, said slots facilitating outward buckling of said distal end portion in response to said relative displacement between said first and second members.

32. The instrumentation of claim 31, wherein each of said plurality of slots has a predetermined shape to provide controlled outward buckling.

33. The instrumentation of claim 19, wherein said distal end portion of said second member comprises a plurality of elements flexibly interconnected in series to form a reformable structure, said reformable structure being collapsible to define said initial configuration and expandable to define said expanded configuration.

34. The instrumentation of claim 33, wherein said plurality of elements are elastically interconnected.

35. The instrumentation of claim 33, wherein said distal end portion has a substantially rectangular-shaped profile when in said initial configuration and a substantially triangular-shaped profile when in said expanded configuration.

36. The instrumentation of claim 33, wherein said plurality of elements are disposed in a substantially uniform orientation when in said initial configuration, and wherein at least some of said plurality of elements are disposed in a non-uniform orientation when in said expanded configuration.

37. The instrumentation of claim 33, wherein said plurality of elements are integrally formed to define a single-piece reformable structure.

38. The instrumentation of claim 33, wherein said second member includes a sleeve portion, said plurality of elements being coupled to said sleeve portion;

and

wherein said second member is displaceable through said sleeve portion and engages at least one of said plurality of elements to transition said plurality of elements between said initial configuration and said expanded configuration.

39. The instrumentation of claim 33, wherein an adjacent pair of said plurality of elements cooperates to define a laterally extending protrusion when in said expanded configuration.

40. The instrumentation of claim 19, wherein reformation between said initial configuration and said expanded configuration is directionally-controlled.

41. Instrumentation for treatment of the spine, comprising:

a first member;

a second member having a distal end portion engaged with said first member, said distal end portion having an initial configuration for placement adjacent a spinal structure and an expanded configuration for displacement of at least a portion of the spinal structure; and

wherein relative displacement between said first and second members causes said distal end portion to reform from said initial configuration toward said expanded configuration; and

wherein said distal end portion of said second member comprises at least one flexible strip of material, said flexible strip of material buckling outwardly in response to said relative displacement between said first and second members to form said expanded configuration, said flexible strip of material having a predetermined shape to provide controlled outward buckling, said predetermined shape including a series of arcuate portions.

42. Instrumentation for treatment of the spine, comprising:

a first member;

a second member having a distal end portion engaged with said first member, said distal end portion having an initial configuration for placement adjacent a spinal structure and an expanded configuration for displacement of at least a portion of the spinal structure; and

wherein relative displacement between said first and second members causes said distal end portion to reform from said initial configuration toward said expanded configuration; and

wherein said distal end portion of said second member defines a plurality of slots, said slots facilitating outward buckling of said distal end portion in response to said relative displacement between said first and second members, each of said plurality of slots has a predetermined shape to provide controlled outward buckling, said predetermined shape being at least partially comprised of an hour-glass shape.

43. Instrumentation for treatment of the spine, comprising:

a member including a deformable distal end portion having an initial configuration for positioning adjacent a spinal structure and a deformed configuration for displacing the spinal structure; and

means for mechanically deforming said distal end portion from said initial configuration toward said deformed configuration to displace at least a portion of the spinal structure in at least one predetermined direction.

44. A method for treatment of the spine, comprising:

providing an instrument including a distal end portion, the distal end portion having an insertion configuration and a deformed configuration;

positioning the distal end portion adjacent a spinal structure while in the insertion configuration; and

deforming the distal end portion toward the deformed configuration to displace at least a portion of the spinal structure, wherein the deforming is directionally controlled.

45. The method of claim 44, further comprising:

deforming the distal end portion back toward the insertion configuration; and

removing the distal end portion from the spinal structure.

46. The method of claim 44, wherein the deforming occurs in response to the imposition of a mechanically induced force.

49. The method of claim 44, wherein the positioning comprises inserting the distal end portion through an outer wall of a vertebral body;

and wherein displacement of the at least a portion of the spinal structure comprises compacting bone to a cavity within the vertebral body.

50. The method of claim 44, further comprising:

inserting a cannula having a working channel through the skin and tissue of a patient;

positioning a distal end of the cannula adjacent the vertebral body; and

inserting the distal end portion of the instrument through the working channel to access the vertebral body.

51. The method of claim 50, further comprising:

inserting a viewing element into the working channel of the cannula to provide visualization of the vertebral body.

47. A method for treatment of the spine, comprising:

providing an instrument including a distal end portion, the distal end portion having an insertion configuration and a deformed configuration and comprising a first member and a second member engaged with the first member; and

positioning the distal end portion adjacent a spinal structure while in the insertion configuration; and

deforming the distal end portion toward the deformed configuration to displace at least a portion of the spinal structure, wherein the deforming occurs in response to relative displacement between the first member and the second member to outwardly deform at least a portion of the second member to form at least one laterally extending projection.

48. The method of claim 47, wherein the relative displacement comprises linear displacement of the first member relative to the second member.