Minimally invasive spine augmentation and stabilization system and method

• US 8,911,497 B2
• Filed: 04/06/2010
• Issued: 12/16/2014
• Est. Priority Date: 04/09/2009
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Chavatte, Kris, Weber, Markus
• Primary Examiner(s): Yang, Andrew
• Assistant Examiner(s): Chang, Olivia C
• Application Number:
  US12/755,256
• Publication Number:
  US 20100262242A1
• Time in Patent Office: 1,715 Days
• Field of Search: 606/246, 606/279, 606 92- 94, 606/105, 623 1711- 1713, 623/17.15, 623/17.16
• US Class Current: 623/17.12
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/3937 Visible markers

Abstract

A minimally invasive system and method for vertebral body augmentation includes an expandable containment device, a chassis including an interior cavity for at least partially enclosing the expandable containment device, a first guidewire, a working cannula, a second guidewire having at least a partially flexible distal end portion and a sleeve for introducing bone filler material through a cannulated passageway of the sleeve and into an interior cavity of the containment device. The containment device preferably includes a plurality of pores for directing the outflow of bone filler material anteriorly within the vertebral body. The containment device and chassis are left interior to the vertebral body subsequent to height restoration and augmentation of the vertebral body.

Claims

1. A system configured to augment a vertebral body, the system comprising:

an expandable containment device that defines an interior device cavity, and further defines a leading end with respect to a direction of insertion of the expandable containment device into the vertebral body, and a trailing end that is opposite the leading end and spaced from the leading end substantially along a first direction;

a chassis that defines an interior chassis cavity that is configured to at least partially receive the expandable containment device;

a cannula that defines a proximal cannula end, a distal cannula end opposite the proximal cannula end, and a cannula passageway that extends between the proximal cannula end and the distal cannula end;

a guidewire sized to be received in the cannula passageway and having distal guidewire end portion, wherein moving the distal guidewire end portion from inside the cannula to outside the cannula causes the distal guidewire end portion to change shape such that the distal guidewire end portion generally extends laterally across the vertebral body when the distal guidewire end portion is disposed inside the vertebral body; and

a sleeve that defines a sleeve passageway, the sleeve sized and configured to be inserted into the cannula passageway, the sleeve configured to be detachably coupled to the chassis such that filler material can be introduced through the sleeve passageway-and into the interior device cavity to expand the expandable containment device along a second direction that is substantially perpendicular to the first direction when the expandable containment device is at least partially disposed in the interior chassis cavity, thereby causing at least a portion of the expandable containment device to be outwardly disposed with respect to the chassis along the second direction.

2. The system of claim 1, further comprising a plunger, the plunger including at least a partially flexible distal end portion and a bore so that the plunger can be advanced over the guidewire.

3. The system of claim 1, wherein the chassis includes an anterior portion and a posterior portion opposite the anterior portion, the anterior portion defining a window that exposes a portion of the expandable containment device such that the expandable containment device expands toward an anterior portion of the vertebral body when filler material is introduced into the interior device cavity and the expandable containment device and the chassis are disposed inside the vertebral body.

4. The system of claim 1, wherein the chassis defines a leading end and a trailing end opposite the trailing end, and the leading end of the chassis includes a taper nose.

5. The system of claim 3, wherein the chassis has a curvature similar to a curvature of the distal guidewire end portion when the distal guidewire end portion is disposed outside the cannula.

6. The system of claim 1, wherein the expandable containment device includes a first end portion, a second end portion opposite the first end portion, and a middle portion that is disposed between the first and second end portions, the middle portion having a circumference smaller than a circumference of either end portion.

7. The system of claim 6, wherein at least a portion of the middle portion of the containment device includes a plurality of anteriorly disposed cement-directing pores.

8. The system of claim 1, wherein the guidewire comprises a shape memory material.

9. The system of claim 1, wherein the distal guidewire end portion has a first shape and a second shape that is different from the first shape, and moving the distal guidewire end portion from inside the cannula to outside the cannula causes the distal guidewire end portion to transition from the first shape to the second shape.

10. The system of claim 9, wherein the first shape is a substantially straight shape, the second shape is a curved shape, and, in the curved shape, the distal guidewire end portion defines a convex side that faces an anterior portion of the vertebral body when the distal guidewire end portion is disposed outside the cannula and inside the vertebral body.

11. The system of claim 10, wherein, in the curved configuration, the distal guidewire end portion defines a convex side that faces a posterior portion of the vertebral body when the distal guidewire end portion is disposed outside the cannula and inside the vertebral body.

12. The system of claim 1, wherein the chassis is configured to remain stationary relative to the expandable containment device while the expandable containment material is expanding due to the introduction of filler material in the interior device cavity.

13. The system of claim 1, wherein the guidewire is a second guidewire, the system further comprising a first guidewire that is configured to extend into the vertebral body, and the first guidewire is configured to be received in the cannula passageway as the cannula moves along the first guidewire until the distal cannula end is disposed adjacent the vertebral body.

14. The system of claim 1, wherein the first guidewire is removable from the cannula passageway and the second guidewire is subsequently insertable through the cannula passageway and into the vertebral body.

15. The system of claim 1, wherein the expandable containment device is coupled to the chassis so that the chassis and the expandable containment device can be introduced simultaneously into the vertebral body.

16. The system of claim 4, wherein the expandable containment device is configured to be coupled to the chassis so that the at least a portion of the expandable containment device is disposed between the leading and trailing ends of the chassis once the chassis is disposed inside the vertebral body.

21. The system of claim 16, wherein moving the chassis from inside the cannula to outside the cannula causes the chassis to bias into the second shape such that the chassis curves along the chassis axis.

17. A system configured to augment a vertebral body, the system comprising:

an expandable containment device that defines an interior device cavity;

a cannula that defines a proximal cannula end, a distal cannula end spaced from the proximal cannula end, and a cannula passageway that extends between the proximal cannula end and the distal cannula end;

a chassis that defines an interior chassis cavity that is configured to at least partially receive the expandable containment device, the chassis configured to be received in the cannula passageway, the chassis defining an insertion end and a trailing end opposite the leading end, the chassis extending along a chassis axis, the chassis having a first shape and a second shape that is different from the first shape, wherein moving the chassis from inside the cannula to outside the cannula causes the chassis to transition from the first shape to the second shape such that the chassis is curved along the chassis axis; and

a sleeve that defines a sleeve passageway, the sleeve sized to be received in the cannula passageway, the sleeve configured to be detachably coupled to the chassis such that filler material can be introduced through the sleeve passageway and into the interior device cavity to expand the expandable containment device when the expandable containment device is at least partially disposed in the interior chassis cavity.

18. The system of claim 17, wherein the first shape is a shape substantially similar to a shape of the cannula passageway, and the second shape is defined as when the chassis is curved along the chassis axis.

19. The system of claim 17, wherein the chassis comprises shape-memory material.

20. The system of claim 17, wherein the chassis includes an anterior portion, a posterior portion opposite the anterior portion, the posterior and anterior portions cooperate so as to at least partially define the interior chassis cavity, the anterior portion defines a window that leads to the interior chassis cavity, and the window exposes a portion of the expandable containment device such that introduction of filler material into the interior device cavity causes the portion of the expandable containment device to expand toward an anterior portion of the vertebral body when the chassis is disposed inside the vertebral body.

22. A system configured to augment a vertebral body, the system comprising:

an expandable containment device that defines an interior device cavity;

a cannula that defines a proximal cannula end, a distal cannula end spaced from the proximal cannula end along an insertion direction, and a cannula passageway that extends between the proximal cannula end and the distal cannula end;

a chassis that defines an interior chassis cavity that is configured to at least partially receive the expandable containment device, the chassis configured to be received in the cannula passageway, the chassis having a first shape and a second shape that is different from the first shape, wherein moving the chassis from inside the cannula to outside the cannula causes the chassis to transition from the first shape to the second shape such that the chassis curves so as to extend laterally with respect to the insertion direction; and

a sleeve that defines a sleeve passageway, the sleeve sized to be received in the cannula passageway, the sleeve configured to be detachably coupled to the chassis such that filler material can be introduced through the sleeve passageway and into the interior device cavity to expand the expandable containment device when the expandable containment device is at least partially disposed in the interior chassis cavity.

23. The system of claim 22, wherein moving the chassis from inside the cannula to outside the cannula causes the chassis to bias into the second shape.

24. The system of claim 22, further comprising a guidewire sized to be received in the cannula passageway and having distal guidewire end portion, wherein moving the distal guidewire end portion from inside the cannula to outside the cannula causes the distal guidewire end portion to change shape such that the distal guidewire end portion generally extends laterally with respect to the insertion direction when the distal guidewire end portion is disposed outside the cannula.

25. The system of claim 22, wherein the chassis includes an anterior portion, a posterior portion opposite the anterior portion, the posterior and anterior portions cooperate so as to at least partially define the interior chassis cavity, the anterior portion defines a window that leads to the interior chassis cavity, and the window exposes a portion of the expandable containment device such that introduction of filler material into the interior device cavity causes the portion of the expandable containment device to expand toward an anterior portion of the vertebral body when the chassis is disposed inside the vertebral body.

26. The system of claim 22, wherein the expandable containment device is coupled to the chassis so that the chassis and the expandable containment device can be introduced simultaneously into the vertebral body.

27. The system of claim 22, wherein the chassis comprises shape-memory material.