Methods for push distraction and for provision of therapy to adjacent motion segments

• US 8,167,947 B2
• Filed: 06/23/2010
• Issued: 05/01/2012
• Est. Priority Date: 12/03/2002
• Status: Expired due to Term

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Ainsworth, Stephen D., Assell, Robert L., Cragg, Andrew H., Wessman, Bradley
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/821,286
• Publication Number:
  US 20110035005A1
• Time in Patent Office: 678 Days
• Field of Search: 623 1711- 1716, 606/279, 606/246, 606/86.A, 606/191, 606/256
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8645 Headless screws, e.g. ligament interference screws
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/0256 for the spine

Abstract

Disclosed are methods and apparatus for the provision of spinal therapy to two or more adjacent motion segments accessed through a trans-sacral approach. The spinal therapies include fusion and dynamic stabilization with and without a distraction of the most cephalad motion segment of the two or more adjacent motion segments provided therapy. The disclosure includes methods and apparatus to impart a push distraction to increase the distance between two adjacent vertebrae. Related concepts for the extraction of previously inserted devices and the delivery and removal of plugs for plugging the interior cavities of implantable devices are disclosed.

Claims

1. A method to axially distract a first intervertebral space between a first vertebral body and a second vertebral body, comprising the steps:

implanting a first assembly in the first vertebral body through an access channel;

implanting a second assembly in the second and more caudal vertebral body through the access channel; and

using a rotating portion of the second assembly to contact a proximal end of the first assembly to push on the first assembly without rotating the first assembly to axially distract the first intervertebral space between the first vertebral body engaged with the first assembly and the second vertebral body engaged with second assembly.

2. The method of claim 1 further comprising a preliminary step of creating the access channel for use in a trans-sacral approach by boring through an anterior face of the sacrum.

3. The method of claim 2 wherein the first assembly and the second assembly are each adapted for delivery through a single access channel created during surgery with an opening at a proximal end of the access channel that receives the first assembly and the second assembly.

4. The method of claim 1 wherein the portion of the second assembly fits within an engagement zone in the proximal end of the first assembly.

5. The method of claim 1 wherein the first assembly comprises a first set of male threads for engagement with a distal vertebral body and a second set of male threads with the same handedness for engagement with a less distal vertebral body.

6. The method of claim 1 wherein the first assembly comprises a distal tip of the first assembly for placement in an intervertebral space cephalad to the first assembly and the first assembly is used to insert material into the intervertebral space cephalad to the first assembly.

7. The method of claim 1 further comprising inserting of a distal end of a plug through a lumen in the second assembly into a cavity in the first assembly before a threaded portion on the exterior of the plug is engaged with a corresponding set of threads.

8. The method of claim 7 wherein the threaded portion on the exterior of the plug engages a set of female threads in a cavity in the first assembly.

9. The method of claim 7 wherein the threaded portion on the exterior of the plug engages a set of female threads in a cavity in a first plug previously inserted into the first assembly.

10. The method of claim 1 further comprising inserting a plug in the first assembly to limit movement of material delivered to an intervertebral space through the first assembly back into the first assembly.

11. The method of claim 1 wherein the rotating portion of the second assembly contacts a thrust bearing on the proximal end of the first assembly to impart an axial force through the thrust bearing.

12. The method of claim 1 wherein implanting the first assembly in the first vertebral body includes implanting at least a portion of the first assembly in a more cephalad intervertebral space adjacent to the first vertebral body and a distal end of the first assembly is expanded to fill at least a portion of the more cephalad intervertebral space.

13. The method of claim 1 wherein implanting the first assembly in the first vertebral body includes implanting a threaded fusion rod that engages the first vertebral body and an adjacent and more cephalad additional vertebral body such that the push from the second assembly axially distracts the first intervertebral space between first vertebral body engaged with the first assembly and the second vertebral body engaged with second assembly without altering a more cephalad intervertebral space between the first vertebral body and the additional vertebral body.

14. The method of claim 13 wherein implanting the first assembly causes axial distraction of the intervertebral space between the first vertebral body and the additional vertebral body through use of dissimilar thread pitches on the first assembly.

15. The method of claim 13 further comprising the preliminary step of creating a trans-sacral axis channel with a caudal to cephalad sequence of vertebral body bores of decreasing cross sectional area for cross sections taken perpendicular to the longitudinal axis of the axis channel such that the vertebral body bores are sized relative to the major diameters of

a first set of threads located on a distal portion of the first assembly for engagement with the additional vertebral body,

a second set of threads on a proximal portion of the first assembly for engagement with the first vertebral body, and

a third set of threads on the second assembly for engagement with the second vertebral body;

allowing cephalad axial advancement of the first, second, and third set of threads of increasing major thread diameters through the axis channel without cross-threading.

16. The method of claim 13 further comprising the preliminary step of creating a trans-sacral axis channel with a caudal to cephalad sequence of vertebral body bores wherein the first vertebral body and the second vertebral body receive bores with the same cross sectional area for cross sections taken perpendicular to the longitudinal axis of the axis channel wherein the steps of:

implanting the first assembly in the first vertebral body; and

implanting the second assembly in the second and more caudal vertebral body are performed using a common driver and timed delivery in order to avoid cross threading.

17. The method of claim 13 wherein the additional vertebral body is a L4 vertebra, the first vertebral body is a L5 vertebra, and the second vertebral body is a sacrum.

18. The method of claim 13 wherein the additional vertebral body is a L3 vertebra, the first vertebral body is a L4 vertebra, and the second vertebral body is a L5 vertebra.

19. The method of claim 13 wherein the first assembly is used to fuse spinal therapy acts to fuse together a more cephalad motion segment comprising the additional vertebral body, the more cephalad intervertebral disc, and the first vertebral body and material is inserted into the more cephalad intervertebral space to promotes fusion, and the material travels through an interior of the first assembly.

20. The method of claim 19 further comprising fusing a first motion segment comprising the first vertebral body, the first intervertebral space, and the second vertebral body after distraction of the first motion segment including insertion of material into the first intervertebral space through the first assembly wherein the material inserted into the first intervertebral space promotes fusion.

21. The method of claim 13 wherein the first assembly is used in provision of dynamic stabilization of a more cephalad motion segment comprising the additional vertebral body, the more cephalad intervertebral disc, and the first vertebral body and material is inserted into the more cephalad intervertebral space to expand a flexible portion of the first assembly.

22. The method of claim 21 further comprising fusing a first motion segment comprising the first vertebral body, the first intervertebral space, and the second vertebral body after distraction of the first motion segment including insertion of material into the first intervertebral space through the first assembly wherein the material inserted into the first intervertebral space promotes fusion.

23. The method of claim 21 wherein the second assembly is used to in provisional of dynamic stabilization a first motion segment comprising the first vertebral body, the first intervertebral space, and the second vertebral body and material is inserted into the first intervertebral space to expand a flexible portion of the second assembly.

24. A method to selectively provide distraction to two different adjacent motion segments comprising:

providing a selected spinal therapy to a first motion segment through use of a first assembly engaged with at least a first vertebral body;

engaging a second assembly with a second vertebral body immediately caudal to the first vertebral body;

pushing a proximal end of the first assembly with a rotating portion of the second assembly to push the first assembly axially away from the second vertebral body without rotating the first assembly;

engaging a third assembly with a third vertebral body caudal to the second vertebral body; and

pushing a proximal end of the second assembly with a rotating portion of the third assembly to push the second assembly axially away from the third vertebral body without rotating the second assembly.

25. The method of claim 24 wherein the first vertebral body is the L4 vertebra, the second vertebral body is the L5 vertebra, and the third vertebral body is the sacrum.

26. The method of claim 24 wherein a selected distraction is provided to the first motion segment through use of a threaded rod engaged with both the first vertebral body and an adjacent and more cephalad vertebral body through use of dissimilar thread pitch on threaded sections of the threaded rod.

27. The method of claim 26 wherein more cephalad vertebral body is the L3 vertebra, the first vertebral body is the L4 vertebra, the second vertebral body is the L5 vertebra, and the third vertebral body is the sacrum.