MINIMALLY INVASIVE INTERBODY DEVICE AND METHOD

• US 20090112323A1
• Filed: 10/29/2007
• Published: 04/30/2009
• Est. Priority Date: 10/29/2007
• Status: Active Grant

• Current Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Spine, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Hestad, Hugh D., Hudgins, Robert Garryl, Maertens, John
• Granted Patent: US 8,043,381 B2
• Time in Patent Office: Days
• US Class Current: 623/17.120
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped

Abstract

The present invention relates to methods and devices for insertion between adjacent vertebrae in a spine following removing at least a portion of a nucleus from within a disc. In one embodiment, the device comprises a member having a flexible wall surrounding an internal volume and a coupler that is secured to the flexible wall. The member is adapted to expand when filled with a first filler material to form an interior cavity. The coupler has a first access point, a second access point, a first coupler side hole, and an optional second coupler side hole. The first and second access points are adapted to removably receive one or more fill tubes. The fill tubes cooperate with the first and optional second coupler side holes to direct the first filler material into the internal volume and a second filler material into the interior cavity.

Claims

1. An interbody device adapted for insertion between adjacent vertebrae in a spine, the device comprising:

a member having a flexible wall surrounding an internal volume, the member being adapted to expand when filled with a first filler material to form an interior cavity; and

a coupler secured to the flexible wall, the coupler having a first access point, a second access point, a first coupler side hole, and an optional second coupler side hole, wherein the first and second access points are adapted to removably receive one or more fill tubes that cooperate with the first and optional second coupler side holes to direct the first filler material into the internal volume and that cooperate to direct a second filler material into the interior cavity.

2. The device of claim 1 further including a keel projecting axially from the member, the keel being adapted to fill with the first filler material and cooperate with a channel machined in the adjacent vertebrae.

3. The device of claim 2 wherein the coupler further includes a third access point, and wherein the second access point opposes the third access point and the second and third access points are adapted to direct the second filler material into the interior cavity.

4. The device of claim 1 further including a plurality of endplate anchors attached to the flexible wall, the endplate anchors being adapted to engage an endplate of the adjacent vertebrae.

5. The device of claim 1 wherein the first filler material comprises a first elastomeric material and the second filler material comprises a second elastomeric material that is more elastic than the first elastomeric material.

6. The device of claim 1 wherein the coupler comprises a rigid material.

7. The device of claim 1 further including a dual lumen fill tube defining a first passage and a second passage, the dual lumen fill tube being adapted to removably cooperate with both the first access point and the second access point, such that when the dual lumen fill tube is inserted into the coupler, a member fill opening at a distal end of the dual lumen fill tube is in fluid communication with the internal volume via the first passage and the first and, optionally, second coupler side holes, and a cavity fill opening at the distal end is in fluid communication with the interior cavity via the second passage and the second access point.

8. The device of claim 1 wherein the first access point is coaxial with the second access point, the first coupler side hole opposes the optional second coupler side hole, and the first and optional second coupler side holes are oriented transverse to the first and second access point.

9. The device of claim 8 wherein the coupler further includes an annular flange comprising a diameter of the second access point that is less than a diameter of the first access point, the annular flange being adapted to prevent tube penetration into the interior cavity.

10. The device of claim 1, wherein a top and a bottom wall enclose the interior cavity.

11. An orthopedic system adapted for insertion between adjacent vertebrae in a spine, the system comprising:

a member having a flexible wall surrounding an internal volume, the member being adapted to expand when filled with a first filler material thereby forming an interior cavity;

a coupler secured to the flexible wall, the coupler having a first access point, a second access point, a first coupler side hole, and an optional second coupler side hole adapted to removably receive one or more fill tubes that cooperate with the first and optional second coupler side holes to direct the first filler material into the internal volume and that cooperate to direct a second filler material into the interior cavity;

a member fill tube defining a first passage and adapted for removable cooperation with the coupler via the first access point such that when the member fill tube is inserted into the coupler, an opening at a distal end of the member fill tube is in fluid communication with the internal volume via the first passage, the first coupler side hole, and the optional second coupler side hole; and

a cavity fill tube defining a second passage and adapted for removable cooperation with the coupler via the first access point and the second access point such that when the cavity fill tube is inserted into the coupler, an opening at a distal end of the cavity fill tube is in fluid communication with the interior cavity via the second passage and the second access point.

12. The system of claim 11 wherein the coupler includes an annular flange adapted to cooperate with the cavity fill tube such that when the cavity fill tube is inserted through the first access point, the distal end of the cavity fill tube abuts the annular flange.

13. The system of claim 11 wherein the coupler further includes a third access point, and wherein the second access point opposes the third access point and the second and third access points are adapted to direct the second filler material into the interior cavity.

14. The system of claim 11 further including a plurality of endplate anchors attached to the flexible wall, the endplate anchors being adapted to engage an endplate of the adjacent vertebrae.

15. The system of claim 14 wherein the first filler material comprises a first elastomeric material and the second filler material comprises a second elastomeric material that is more elastic than the first elastomeric material.

16. The system of claim 11 wherein the coupler comprises a rigid material.

17. A method of treating a spine following forming an incision in an annulus of a disc between adjacent vertebrae and removing at least a portion of a nucleus from within the disc to form a space surrounded by the annulus, the method comprising:

placing an interbody device within the disc space, the interbody device comprising;

a member having a flexible wall surrounding an internal volume, the member being adapted to expand when filled with a first filler material to form an interior cavity; and

a coupler secured to the flexible wall, the coupler having a first access point, a second access point, wherein the first and second access points are adapted to removably receive one or more fill tubes that cooperate with a first and an optional second coupler side holes to direct the first filler material into the internal volume and that cooperate to direct a second filler material into the interior cavity;

filling the internal volume with the first filler material, the first filler material comprising a first elastomeric material; and

filling the interior cavity with the second filler material, the second filler material comprising a second elastomeric material, wherein the second elastomeric material is more elastic than the first elastomeric material.

18. The method of claim 17 further comprising:

providing the first filler material through the first access point, the first coupler side hole, and the optional second coupler side hole into the internal volume, thereby expanding the member to form the interior cavity bordered by the member; and

providing the second filler material through both the first access point and the second access point into the interior cavity, wherein upon hardening of the second filler material, the adjacent vertebrae are substantially fused to one another.

19. The method of claim 17 wherein filling the internal volume includes providing a member fill tube in removable cooperation with the coupler, wherein the member fill tube cooperates with the first access point and a portion of the member fill tube substantially blocks the second access point such that while filling the member, the first filler material passes through the member fill tube, through the first access point, through one or both of the first and the optional second coupler side holes, and into the internal volume.

20. The method of claim 19 wherein filling the interior cavity includes withdrawing the member fill tube from the coupler and inserting a cavity fill tube into the coupler such that a portion of the cavity fill tube substantially blocks the first access point and the second access point, whereby providing the second filler material includes providing the second filler material through the cavity fill tube, through the first access point, through the second access point, and into the interior cavity.

21. The method of claim 20 wherein inserting the cavity fill tube into the coupler includes inserting the cavity fill tube until the cavity fill tube abuts an annular flange proximate the second access point.

22. The method of claim 17 further including forming a first channel in an endplate of an upper-adjacent vertebra and forming a second channel in an endplate of a lower-adjacent vertebra prior to placing the member, wherein the member has an upper keel and a lower keel that axially project from the member within the disc space, such that during filling the internal volume of the member, the upper keel expands into the first channel and the lower keel expands into the second channel.

23. The method of claim 17 wherein filling the internal volume of the member causes a plurality of endplate anchors to contact at least one endplate of the adjacent vertebrae.

24. The method of claim 17 wherein filling the internal volume and filling the interior cavity includes providing the first filler material and the second filler material, respectively, through a dual lumen fill tube comprising a first passage in fluid communication with the internal volume and a second passage in fluid communication with the interior cavity, whereby the first filler material passes through the first passage and into the internal volume, and the second filler material passes through the second passage and into the interior cavity.

25. The method of claim 17 further comprising:

providing a containment barrier for the second filler material.