Total disc replacement system and related methods

• US 9,168,149 B2
• Filed: 10/28/2014
• Issued: 10/27/2015
• Est. Priority Date: 07/28/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Navasive Incorporated
• Inventors: Curran, Matthew, Pimenta, Luiz, Martinelli, Scot, Cornwall, G. Bryan, Spangler, Jonathan D.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US14/525,440
• Publication Number:
  US 20150045896A1
• Time in Patent Office: 364 Days
• Field of Search: 606/246, 606/279, 623/17.11, 623/17.14, 623/17.15, 623/17.16
• US Class Current: 1/1
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30364 Rotation about the common longitudinal axis
• CPC Class Codes: A61F 2002/30369 Limited lateral translation of the protrusion within a larger recess
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30649 Ball-and-socket joints
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/443 having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/4622 having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4628 with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2

Abstract

Total disc replacement systems and related methods involving a lateral, trans-psoas surgical approach to the spine while performing at least one of continuous and intermittent intra-operative neural monitoring of the psoas muscle to avoid injury during introduction.

Claims

1. A total disc replacement implant positionable via a lateral trans-psoas surgical approach to the spine into a position within an intervertebral disc space between a first vertebra and a second vertebra comprising:

a first anchor plate, said first anchor plate having a first rectangular outer boundary, a first surface for engaging said first vertebra and a second interior surface opposite said first surface, said second interior surface having an integral semi-spherical articulation recess situated within the first outer boundary;

a second anchor plate, said second anchor plate having second rectangular outer boundary, a third surface for engaging said second vertebra, and a fourth interior surface opposite said third surface, the first anchor plate and second anchor plate together having an implant length defined by a distance along an X-axis, the X-axis being generally parallel to the coronal plane when the implant is positioned within the intervertebral space, an implant width defined by a distance along a Z-axis, the Z-axis being generally parallel to the sagittal plane when the implant is positioned in the intervertebral space, the implant length is at least 40 mm and the implant width being between 18 mma and 22 mm; and

an articulation element joined in a fixed relationship with said fourth interior surface, said articulation element having a semi-spherical articular surface dimensioned to articulate within said recess of said first anchor plate, said articulation element being situated within the second outer boundary.

2. The disc replacement implant of claim 1, wherein said first anchor plate may rotate freely relative to said second anchor plate about any axis in a XZ plane that intersects with a Y-axis.

3. The disc replacement implant of claim 1, wherein each of the first outer boundary and second outer boundary include a posterior side extending the entire implant length and parallel to said Z-axis and an anterior side extending the entire implant length and parallel to said Z-axis is positioned in the intervertebral disc space.

4. The disc replacement implant of claim 3, wherein the articulation recess and the articulation element are offset posteriorly such that they are closer to the posterior side of the first and second anchor plates than they are to the anterior side of the first and second anchor plates.

5. The disc replacement implant of claim 4, wherein at least one of the first anchor plate and second anchor plate includes at least one anti-migration feature situated to facilitate confirmation the proper intervertebral position of the posteriorly offset articulation recess and articulation element via radiographic imaging when said implant is positioned in the intervertebral disc space.

6. The disc replacement implant of claim 5, wherein each of said first anchor plate and said second anchor plate include at least one anti-migration feature aligned along a lateral midline of said anchor plate and at least two anti-migration features aligned along a longitudinal midline of said anchor plate.

7. The disc replacement of claim 4, further including an insertion instrument, the insertion instrument being configured to ensure said disc replacement implant is inserted in the proper anterior-posterior orientation.

8. The disc replacement of claim 7, wherein said insertion instrument includes indicia on a handle portion that ensures the disc replacement implant is inserted in the proper orientation.

9. The method according to claim 8, wherein said indicia is at least one orientation marker visible to a clinician during insertion.

10. The method according to claim 9, wherein said orientation marker is at least one of a button and an alpha-numeric symbol.

11. The disc replacement implant of claim 1, wherein at least one of said anchor plates has an angled cross-section to force the adjacent vertebral bodies into lordosis when the total disc replacement is introduced into a lumbar spine.

12. The disc replacement implant of claim 1, wherein the first anchor plate, second anchor plate, and articulation element are all formed of titanium.

13. The disc replacement implant of claim 12, wherein at least a portion of said first anchor plate first surface and at least a portion of said second anchor plate third surface is coated with zirconium oxide.

14. The disc replacement implant of claim 1, wherein the first anchor plate first surface is convex.

15. The disc replacement implant of claim 1, wherein the first anchor plate includes an aperture adjacent a first lateral end and an aperture adjacent a second lateral end, the apertures opening in said first surface and said second interior surface, and a wherein the second anchor plate includes an aperture adjacent a first lateral end and an aperture adjacent a second lateral end, the apertures opening in said third surface and said fourth interior surface.

16. The disc replacement implant of claim 15, wherein said first anchor plate includes at least one recess adjacent each of said first lateral end and said second lateral end for engaging an insertion instrument.