Total disc replacement system and related methods

• US 9,610,171 B2
• Filed: 10/27/2015
• Issued: 04/04/2017
• Est. Priority Date: 07/28/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive 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:
  US14/924,385
• Publication Number:
  US 20160113778A1
• Time in Patent Office: 525 Days
• Field of Search: 606246, 606279, 623 1711, 623 1714, 623 1715, 623 1716
• 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 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 by performing at least one of continuous and intermittent intra-operative neural monitoring to safely establish the operative corridor through a psoas muscle adjacent to the disc space;

implanting into the intervertebral disc space a lateral total disc replacement system;

wherein said disc replacement system comprises two anchor plates and at least one intradiscal element, said intradiscal element positioned within a posterior region of said disc space; and

closing said operative corridor.

2. The method according to claim 1, wherein the step of implanting includes positioning the intradiscal element within the posterior region of the disc space when the disc replacement system is centered along the longitudinal midline and lateral midline of the disc space.

3. The method according to claim 2, wherein at least one of said anchor plates include at least one anti-migration feature aligned along the longitudinal midline of said 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 at least one of said anchor plates 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 with said radiographic marker at least one of during and after insertion.

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

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

positioning said at least one anti-migration feature of said 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 anchor plates and said intradiscal element are formed of at least one of metal, ceramics, polymers, and a combination thereof.

9. The method according to claim 8, wherein said anchor plates and said intradiscal element are formed of the same material.

10. The method according to claim 9, wherein said anchor plates and said intradiscal element are formed of different materials.

11. The method according to 8, wherein said at least one of said anchor plates and said intradiscal element are coated with zirconium oxide.

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

preparing said disc space prior to inserting said disc replacement system into said space, said preparation step including cutting the annulus of said intervertebral disc at a location contra-lateral to an insertion channel formed in said disc space.

13. The method according to claim 10, comprising the additional steps of:

implanting an interbody implant within at least one of an adjacent disc space and a remote disc space from said disc space; and

implanting said interbody implant at least one of before and after inserting said disc replacement system into said disc space.

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

15. The method according to claim 13, wherein said 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.

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

engaging said disc replacement system to an insertion instrument to perform said insertion into the disc space.

17. The method according to claim 16, wherein said disc replacement system has a posterior side and an anterior side and wherein said intradiscal element is located in a posteriorly biased position.

18. A total disc replacement system comprising:

a first anchor plate, said first anchor plate having a first vertebra engaging surface and a second surface opposite said first surface, said second surface having a recess;

a second anchor plate, said second anchor plate having a first vertebra engaging surface, and a second surface opposite said first surface, said second surface having a post element; and

an intradiscal element;

said intradiscal element having an articular surface dimensioned to articulate within said recess of said first anchor plate and a generally planar surface opposite said articular surface, said planar surface including a central bore for mating with said post member of said second anchor plate, said disc replacement system configured for simultaneous lateral insertion into a disc space via a retroperitoneal, trans-psoas approach while performing at least one of continuous and intermittent intra-operative neural monitoring to safely establish an operative corridor through a psoas muscle adjacent to the disc space; and

wherein said intradiscal element is positioned within a posterior region of said disc space.