Total Disc Replacement System and Related Methods

• US 20130289726A1
• Filed: 12/11/2012
• Published: 10/31/2013
• Est. Priority Date: 07/28/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Pimenta, Luiz, Cornwall, G. Bryan, Curran, Matthew, Martinelli, Scot, Spangler, Jonathan D.
• Granted Patent: US 8,870,960 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• 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

A total disc replacement (TDR) system for lateral insertion into the spine, involving a first anchor plate having a first surface for engaging a first vertebra and a second surface including a cutout region, a second anchor plate having a first surface for engaging a second vertebra and a second surface including a cutout region, at least one pair of intradiscal inserts, each insert having a first surface for engaging with said anchor plates and a second surface for engaging with an intradiscal element, and an intradiscal element including a first articular surface having a generally arcuate cross-section for articulating with said first intradiscal insert, and a second generally planar surface for interacting with a second intradiscal insert.

Claims

1. A method for replacing an intervertebral disc comprising the step of:

establishing an operative corridor to an intervertebral disc space via a lateral, trans-psoas surgical approach that leaves the Anterior Longitudinal Ligament (ALL) intact and includes monitoring nerves in the psoas muscle with a neurophysiology based monitoring system to avoid damaging said nerves;

preparing the intervertebral disc space for receipt of a disc replacement implant, the disc replacement implant including a first anchor plate with a first surface for contacting a first vertebra adjacent the disc space and a second interior surface having, an articulation recess integrally formed therein and offset posteriorly from a center point of the second interior surface, a second anchor plate having a third surface for contacting a second vertebra adjacent the disc space and a fourth interior surface, and an intradiscal element integrally joined with the fourth interior surface and offset posteriorly from a center point of the fourth surface, the intradiscal element configured to articulate with the articulation recess, 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 interbody 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 being greater than the implant width, and such that the implant extends from the apophyseal ring at a first lateral aspect of the intervertebral disc space to the apophyseal ring at a second lateral aspect of the intervertebral disc space when the implant is positioned in the intervertebral disc space;

simultaneously introducing the first anchor plate and second anchor plate through the lateral trans-psoas operative corridor into the intervertebral disc space such that the intradiscal element of the second anchor plate cooperates within the articulation recess of the first anchor plate to post-operatively allow motion between the first and second vertebrae.

2. The method according to claim 1, wherein the disc replacement implant is positioned within the intervertebral disc space with the first anchor plate and second anchor plate, centered along a longitudinal midline of the disc space, such that the intradiscal element is situated posterior to the longitudinal.

3. The method according to claim 2, wherein said first anchor plate includes at least one anti-migration feature aligned along the longitudinal midline of said first anchor plate and said second anchor plate includes at least one anti-migration feature aligned along the longitudinal midline of said second anchor plate.

4. The method according to claim 3, comprising the additional step of:

implanting a radiographic marker in at least one of an upper vertebra and a lower vertebra adjacent to said disc space and in line with said longitudinal midline of said disc space prior to inserting said disc replacement system into said disc space.

5. The method according to claim 3, comprising the additional steps of:

positioning said at least one anti-migration feature of said first anchor plate and said at least one anti-migration feature of said second anchor plate in line with said radiographic marker prior to and during insertion of said disc replacement system; and

using at least one of a medical imaging device and visual inspection to check the alignment of said at least one anti-migration feature of said first anchor plate and said at least one anti-migration feature of said second anchor plate with said radiographic marker at least one of during and after insertion.

6. The method according to claim 2, wherein said first anchor plate includes at least one anti-migration feature aligned along the lateral midline of said first anchor plate and said second anchor plate includes at least one anti-migration feature aligned along, the lateral midline of said second anchor plate.

7. The method according to claim 6, comprising the additional steps of:

positioning said at least one anti-migration feature of said first anchor plate and said at least one anti-migration feature of said second anchor plate in line with the spinous process of at least one of the adjacent vertebrae; and

using a medical imaging device to check the alignment of said at least one anti-migration feature with said spinous process at least one of during and after insertion.

8. The method according to claim 1, wherein said first anchor plate, second anchor plate, and said intradiscal element are formed of.

9. The method according to claim 1, wherein said first anchor plate, second anchor plate, and said intradiscal element are formed of the same material.

10. The method according to claim 8, wherein at least a portion of said first surface of said first anchor plate and at least a portion of said third surface of said second anchor plate is coated with zirconium oxide.

11. The method according to claim 1, wherein preparing said disc space comprises cutting the annulus of said intervertebral disc at a location contralateral to the operative corridor.

12. The method according to claim 1, comprising the additional step of:

implanting an interbody implant within an additional intervertebral disc space one of adjacent to and remote from said intervertebral disc space and one of before and after introducing said disc replacement implant in said intervertebral disc space.

13. The method according to claim 12, wherein said additional interbody implant is at least one of an anterior lumbar interbody fusion implant, a lateral total disc replacement, and a nucleus replacement implant.

14. The method according to claim 12, wherein said additional interbody implant is at least one of a fusion implant, a nucleus replacement, and a total disc replacement introduced via a trans-sacral surgical approach.

15. The method according to claim 1, comprising the additional step of:

introducing said disc replacement implant into said intervertebral disc space with an insertion instrument, said insertion instrument being configured to ensure said disc replacement system is inserted in the proper anterior-posterior orientation.

16. The method according to claim 1, wherein said each of said first anchor plate and second anchor plate have 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.

17. The method according to claim 16, wherein said implant width is between 18 mm and 22 mm and said implant length is at least 40 mm.

18. The method according to claim 15, wherein said insertion instrument includes indicia on a handle portion that ensures the disc replacement implant is inserted in the proper orientation.

19. The method according to claim 18, wherein said indicia is at least one orientation marker visible to a clinician during insertion.

20. The method according to claim 19, wherein said orientation marker is at least one of a button and an alpha-numeric symbol.

21. The method of claim 2, wherein at least one of said first anchor plate and said second anchor plate has an angled cross-section to force the adjacent vertebral bodies into lordosis when the total disc replacement is introduced into a lumbar spine.