Surgical instrumentation and method for treatment of a spinal structure

• US 20050182417A1
• Filed: 02/12/2004
• Published: 08/18/2005
• Est. Priority Date: 02/12/2004
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Pagano, Paul J.
• Granted Patent: US 7,641,664 B2
• Time in Patent Office: Days
• US Class Current: 606/92
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking

Abstract

Instrumentation and method for treatment of a spinal structure, comprising an elongate member including a deformable distal portion having an initial configuration for placement within the spinal structure and a deformed configuration wherein the distal portion is outwardly deformed to form a cavity in the spinal structure. The elongate member comprises a cannula member and an actuator member that is removably positioned within the cannula member and configured to transition the deformable distal portion from the initial configuration toward the deformed configuration. The actuator member is selectively removed from the cannula member to provide a passageway for delivery of a material into the cavity formed in the spinal structure.

Claims

1. Instrumentation for treatment of the spine, comprising:

an elongate member extending along a longitudinal axis and including a deformable distal portion having an initial configuration for placement within a spinal structure and a deformed configuration wherein said distal portion is outwardly deformed to form a cavity in the spinal structure, said elongate member comprising a cannula member and an actuator member, said actuator member being removably positioned within said cannula member and configured to transition said deformable distal portion from said initial configuration toward said deformed configuration, said actuator member being selectively removed from said cannula member to provide a passageway for delivery of a material into the cavity formed in the spinal structure.

2. The instrumentation of claim 1, wherein said deformed configuration of said deformable distal portion comprises at least one transverse projection.

3. The instrumentation of claim 2, wherein said at least one transverse projection is arranged along a single transverse axis such that outward deformation of said deformable distal portion is uniaxial along said transverse axis.

4. The instrumentation of claim 2, wherein said deformed configuration of said deformable distal portion comprises a single transverse projection such that outward deformation of said deformable distal portion is unidirectional.

5. The instrumentation of claim 1, wherein outward deformation of said deformable distal portion is selectively controlled to generate a controlled magnitude of force against the spinal structure.

6. The instrumentation of claim 1, wherein said cannula member defines a transverse opening communicating with said passageway, said actuator member including a deformable element disposed adjacent said transverse opening;

and

wherein said deformable configuration comprises an outward deformation of said deformable element to form a transverse projection extending through said transverse opening in said cannula member.

7. The instrumentation of claim 6, wherein said deformable element has a substantially flat configuration when in said initial configuration and an arcuate configuration when transitioned to said deformed configuration.

8. The instrumentation of claim 6, wherein said deformable element comprises a flexible strip of material to facilitate transitioning to said deformed configuration and formation of said transverse projection.

9. The instrumentation of claim 6, wherein said deformable element comprises a flat spring;

and

wherein axial compression of said flat spring results in transitioning to said deformed configuration and formation of said transverse projection.

10. The instrumentation of claim 6, wherein said outward deformation of said deformable element results from relative displacement between said actuator member and said cannula member.

11. The instrumentation of claim 10, further comprising an actuator mechanism coupled between said actuator member and said cannula member to regulate said relative displacement therebetween and to generate a controlled magnitude of force against the spinal structure.

12. The instrumentation of claim 10, further comprising a retaining element engaged between said actuator member and said cannula member to selectively prevent said relative displacement and transitioning of said deformable distal portion from said initial configuration toward said deformed configuration;

and

wherein disengagement of said retaining element from between said actuator member and said cannula member permits said relative linear displacement and transitioning of said deformable distal portion from said initial configuration toward said deformed configuration.

13. The instrumentation of claim 12, further comprising a handle attached to said cannula member and an actuator button attached to said actuator member, said retaining element positioned between said handle and said actuator button to selectively prevent transitioning of said deformable distal portion from said initial configuration toward said deformed configuration.

14. The instrumentation of claim 1, further comprising a retaining element adapted to selectively prevent transitioning of said deformable distal portion from said initial configuration toward said deformed configuration.

15. The instrumentation of claim 1, wherein a distal end of said elongate member comprises a pointed trocar tip to facilitate introduction of said deformable distal portion into the spinal structure.

16. The instrumentation of claim 1, wherein said material comprises a flowable material.

17. The instrumentation of claim 16, wherein said material comprises a settable material providing internal support to the cavity formed in the spinal structure.

18. The instrumentation of claim 17, wherein said material comprises bone cement.

19. The instrumentation of claim 16, wherein said elongate member includes a connector portion defining a passage in communication with said passageway in said cannula member, said connector portion adapted for coupling with a material delivery system to inject said flowable material through said passageway in said cannula member and into the cavity in the spinal structure.

20. The instrumentation of claim 19, wherein said connector portion comprises a lure-type fitting.

21. The instrumentation of claim 19, wherein said connector portion comprises a threaded fitting adapted for threading engagement with said material delivery system.

22. Instrumentation for treatment of the spine, comprising:

a cannula member extending along a longitudinal axis and including a distal portion, said cannula member defining an axial passage and a transverse opening positioned adjacent said distal portion and communicating with said axial passage; and

an actuator member removably positioned within said axial passage of said cannula member and including a deformable portion positioned adjacent said transverse opening, said deformable portion being transitionable between an initial configuration for placement within a spinal structure and a deformed configuration defining a transverse projection extending through said transverse opening in said cannula member to form a cavity in the spinal structure; and

wherein said actuator member is selectively removed from said cannula member to allow for delivery of a material through said axial passage and into the cavity formed in the spinal structure.

23. The instrumentation of claim 22, wherein outward deformation of said deformable portion is selectively controlled to generate a controlled magnitude of force against the spinal structure.

24. The instrumentation of claim 22, wherein said deformable portion has a substantially flat configuration when in said initial configuration and an arcuate configuration when transitioned to said deformed configuration.

25. The instrumentation of claim 22, wherein said deformable portion comprises a flexible strip of material to facilitate transitioning to said deformed configuration and formation of said transverse projection.

26. The instrumentation of claim 22, wherein said deformable element comprises a flat spring;

and

wherein axial compression of said flat spring results in transitioning to said deformed configuration and formation of said transverse projection.

27. The instrumentation of claim 22, wherein outward deformation of said deformable portion results from relative displacement between said actuator member and said cannula member.

28. The instrumentation of claim 27, further comprising an actuator mechanism coupled between said actuator member and said cannula member to regulate said relative displacement therebetween and generate a controlled magnitude of force against the spinal structure.

29. The instrumentation of claim 22, wherein a distal end of said cannula member comprises a pointed trocar tip to facilitate introduction into the spinal structure.

30. The instrumentation of claim 22, wherein said material comprises a flowable material.

31. The instrumentation of claim 30, wherein said material comprises a settable bone cement to provide internal support to the cavity formed in the spinal structure.

32. The instrumentation of claim 30, wherein said elongate member includes a connector portion defining a passage in communication with said axial passage in said cannula member, said connector portion adapted for coupling with a material delivery system to inject said flowable material through said axial passage and into the cavity in the spinal structure.

33. Instrumentation for treatment of the spine, comprising:

an elongate member extending along a longitudinal axis and including a deformable distal portion having an initial configuration for insertion into a spinal structure and a mechanically deformed configuration for forming a cavity within the spinal structure; and

means for mechanically deforming said distal portion from said initial configuration toward said mechanically deformed configuration to form the cavity in the spinal structure; and

means for delivering a material through said elongate member and into the cavity in the spinal structure.

34. The instrumentation of claim 33, further comprising means for selectively preventing transitioning of the deformable distal portion from the initial configuration toward the mechanically deformed configuration.

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

providing an instrument defining a cannula passage extending along a longitudinal axis and including a deformable distal portion having an insertion configuration and a deformed configuration;

positioning the distal portion of the instrument within a spinal structure while in the insertion configuration;

transitioning the distal portion of the instrument toward the deformed configuration and forming a cavity within the spinal structure; and

delivering a material through the cannula passage and into the cavity in the spinal structure.

36. The method of claim 35, wherein the transitioning of the distal portion of the instrument toward the deformed configuration is uniaxial along the transverse axis.

37. The method of claim 35, wherein the transitioning of the distal portion of the instrument toward the deformed configuration is unidirectional along the transverse axis.

38. The method of claim 35, wherein the transitioning comprises mechanically deforming the distal portion of the instrument to form at least one transverse projection for forming the cavity within the spinal structure.

39. The method of claim 38, wherein the least one transverse projection is arranged along a single transverse axis such that the transitioning of the distal portion of the instrument toward the deformed configuration is axially controlled along the transverse axis.

40. The method of claim 38, wherein the deformed configuration of the distal portion of the instrument defines a single transverse projection such that the transitioning of the distal portion of the instrument toward the deformed configuration is directionally controlled along the transverse axis.

41. The method of claim 38, wherein the transitioning of the distal portion toward the deformed configuration comprises selectively controlling the deforming to generate a controlled magnitude of force against the spinal structure.

42. The method of claim 35, wherein the instrument comprises:

a cannula member defining the cannula passage and defining a transverse opening communicating with the cannula passage; and

an actuator member positioned within the cannula passage and including a deformable element disposed adjacent the transverse opening; and

wherein the transitioning comprises outwardly deforming the deformable element to form a transverse projection extending through the transverse opening in the cannula member.

43. The method of claim 42, wherein the outwardly deforming of the deformable element comprises outward buckling.

44. The method of claim 43, wherein the deformable element of the actuator member comprises a thin strip of material to facilitate the outward buckling.

45. The method of claim 43, wherein the outward buckling of the deformable element results from relative linear displacement between the actuator member and the cannula member.

46. The method of claim 35, wherein the instrument comprises a cannula member defining the cannula passage and an actuator member removably positioned within the cannula passage and configured to provide the transitioning of the distal portion of the instrument from the insertion configuration toward the deformed configuration;

and

wherein the method further comprises selectively removing the actuator member from the cannula member to allow for the delivering of the material through the cannula passage and into the cavity.

47. The method of claim 35, wherein the transitioning occurs in response to the imposition of a mechanically induced force.

48. The method of claim 47, wherein the instrument comprises a first member and a second member engaged with the first member;

and

wherein the transitioning 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 transverse projection.

49. The method of claim 48, wherein the relative displacement comprises relative linear displacement between the first member and the second member.

50. The method of claim 48, wherein the relative displacement between the first member and the second member is regulated to control the outward deformation of the at least a portion of the second member and to generate a controlled magnitude of force against the spinal structure.

51. The method of claim 35, wherein the instrument includes a retaining element for selectively preventing the transitioning of the distal portion of the instrument from the insertion configuration toward the deformed configuration.

52. The method of claim 51, further comprising disengaging the retaining element from the instrument subsequent to the positioning to allow for the transitioning of the distal portion of the instrument from the insertion configuration toward the deformed configuration.

53. The method of claim 35, wherein the positioning comprises inserting the distal portion of the instrument into a vertebral body;

and

wherein the transitioning of the distal portion of the instrument toward the deformed configuration results in compacting cancellous bone to form the cavity within the vertebral body.

54. The method of claim 35, wherein the positioning comprises inserting the distal portion of the instrument into a vertebral body;

and

wherein the transitioning of the distal portion of the instrument toward the deformed configuration results in at least partially reducing a compression fracture to form the cavity within the vertebral body.

55. The method of claim 35, wherein the positioning comprises inserting the distal portion of the instrument into an intervertebral disc space between adjacent vertebral bodies;

and

wherein the transitioning of the distal portion of the instrument toward the deformed configuration exerts a force onto the adjacent vertebral bodies to distract the intervertebral disc space.

56. The method of claim 35, wherein the instrument includes a trocar tip;

and

wherein the positioning comprises introducing the trocar tip into the spinal structure to facilitate insertion of the deformable distal portion of the instrument into the spinal structure.

57. The method of claim 56, wherein the positioning is accomplished by imparting an impaction force onto the instrument to facilitate insertion of the deformable distal portion into the spinal structure.

58. The method of claim 35, wherein the material comprises a flowable material.

59. The method of claim 58, wherein the instrument includes a connector portion defining a passageway in communication with the cannula passage;

and

wherein the delivering comprises coupling a material delivery system to the connector portion and injecting the material through the cannula passage and into the cavity in the spinal structure.

60. The method of claim 57, wherein the flowable material comprises a bone cement capable of setting to a hardened condition subsequent to the delivering.