# Patent

## Title
Artificial disc replacements with natural kinematics

## Abstract

This invention improves upon prior art total disc replacements (TDRs) by more closely replicating the kinematics of a natural disc. The preferred embodiments feature two or more fixed centers of rotation (CORs) and an optional variable COR (VCOR) as the artificial disk replacement (ADR) translates from a fixed posterior COR that lies posterior to the COR of the TDR to facilitate normal disc motion. The use of two or more CORs allows more flexion and more extension than permitted by the facet joints and the artificial facet (AF). AF joint-like components may also be incorporated into the design to restrict excessive translation, rotation, and/or lateral bending.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of U.S. patent application Ser. No. 14/881,879, filed on Oct. 13, 2015, which is a continuation of U.S. patent application Ser. No. 14/308,201, filed on Jun. 18, 2014, now U.S. Pat. No. 9,168,146, which is a continuation of U.S. patent application Ser. No. 13/737,500, filed on Jan. 9, 2013, now U.S. Pat. No. 8,784,492, which is a continuation of U.S. patent application Ser. No. 10/512,515, filed on Jun. 3, 2005, now U.S. Pat. No. 8,366,772, which is a national phase entry under 35 U.S.C. § 371 of International Application No. PCT/US2003/012500 filed Apr. 23, 2003, published in English, which is a continuation of U.S. patent application Ser. No. 10/420,423 filed Apr. 22, 2003, now U.S. Pat. No. 6,706,068, which claims the benefit of the filing date of U.S. Provisional Patent Application Nos. 60,374,747 filed Apr. 23, 2002, 60/445,958 filed Feb. 7, 2003 and 60/449,642 filed Feb. 24, 2003, the disclosures of which are incorporated herein by reference.


BACKGROUND OF THE INVENTION
This invention relates generally to artificial disc replacements (ADRs) and, more particularly, to ADRs facilitating more natural kinematics.
Many spinal conditions, including degenerative disc disease, can be treated by spinal fusion or through artificial disc replacement (ADR). ADR has several advantages over spinal fusion. The most important advantage of ADR is the preservation of spinal motion. Spinal fusion eliminates motion across the fused segments of the spine. Consequently, the discs adjacent to the fused level are subjected to increased stress. The increased stress increases the changes of future surgery to treat the degeneration of the discs adjacent to the fusion. However, motion through an ADR also allows motion through the facet joints. Motion across arthritic facet joints could lead to pain following ADR. Some surgeons believe patients with degenerative disc and arthritis of the facet joints are not candidates for ADR.
Current ADR designs do not attempt to limit the pressure across the facet joints or facet joint motion. Indeed, prior art ADRs generally do not restrict motion. For example, some ADR designs place bags of hydrogel into the disc space which do not limit motion in any direction. In fact, ADRs of this kind may not, by themselves, provide sufficient distraction across the disc space. ADR designs with metal plates and polyethylene spacers may restrict translation but they do not limit the other motions mentioned above. The articular surface of the poly spacer is generally convex in all directions. Some ADR designs limit motion translation by attaching the ADR halves at a hinge.
One of the most important features of an artificial disc replacement (ADR) is its ability to replicate the kinematics of a natural disc. ADRs that replicate the kinematics of a normal disc are less likely to transfer additional forces above and below the replaced disc. In addition, ADRs with natural kinematics are less likely to stress the facet joints and the annulus fibrosus (AF) at the level of the disc replacement. Replicating the movements of the natural disc also decreases the risk of separation of the ADR from the vertebrae above and below the ADR.
The kinematics of ADRs are governed by the range of motion (ROM), the location of the center of rotation (COR) and the presence (or absence) of a variable center of rotation (VCOR). Generally ROM is limited by the facet joints and the AF. A natural disc has VCOR, that is, the COR varies as the spine bends forward (flexion) and backward (extension). Typically, the vertebra above a natural disc translates forward 1-2 mm as the spine is flexed.
Prior art total disc replacements (TDR), that is, ADRs with rigid plates that attach to the vertebrae, do not replicate the kinematics of the natural disc. Generally, the COR lies too anterior. Most prior art TDRs also rely on a single, fixed COR. As a result, many of the prior art TDRs have a limited ROM.
BRIEF SUMMARY OF THE INVENTION
This invention improves upon prior art TDRs by more closely replicating the kinematics of a natural disc. The preferred embodiments feature two or more fixed centers of rotation (CORs) and an optional variable COR (VCOR) as the ADR translates from a fixed posterior COR to a more anterior COR.
The multiple CORs permit a TDR with a posterior COR that lies posterior to the COR of the TDR to facilitate normal disc motion. The use of two or more CORs allow more flexion and more extension than permitted by the facet joints and the AF. Artificial facet join-like components may also be incorporated into the design to restrict excessive translation, rotation, and/or lateral bending.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sagittal cross section of a total disc replacement (TDR) according to the invention having three fixed centers of rotation (CORs);
FIG. 2 is a sagittal cross section of the TDR of FIG. 1 extended 5 degrees, more or less;
FIG. 3 is a sagittal cross section of the TDR of FIG. 1 showing various degrees of flexion;
FIG. 4 is a sagittal cross section of another embodiment of a TDR having an anterior COR and a posterior COR;
FIG. 5 is a sagittal cross section of the TDR of FIG. 4 in a flexed position.
FIGS. 6A and 6B are drawings that show the articulating surfaces of the TDR drawn in FIG. 4.
FIG. 7 is a sagittal cross section of another embodiment having an anterior and a posterior COR;
FIG. 8 is a sagittal cross section of the TDR of FIG. 7 in a more flexed position;
FIG. 9 is a view of the articulating surfaces of the TDR of FIG. 7;
FIG. 10 is an oblique view of the assembled TDR drawn in FIG. 7;
FIG. 11A is a view of the anterior side of a cervical embodiment of the TDR of FIG. 7;
FIG. 11B is a view of the lateral side of the TDR of FIG. 11A;
FIG. 11C is a view of the interior of the TDR drawn in FIG. 11A;
FIG. 12A is a sagittal cross section of yet a further embodiment of an artificial disc replacement according to the invention;
FIG. 12B is a sagittal cross section of the embodiment of the ADR of FIG. 12A;
FIG. 12C is a view of the side of the ADR of FIG. 12A;
FIG. 13A is a view of the side of the ADR of FIG. 12A including modular shims; and
FIG. 13B is an exploded view of the embodiment of the ADR shown in FIG. 13A.



DETAILED DESCRIPTION
My U.S. Provisional Patent Application Ser. No. 60/374,747, incorporated herein by reference, describes various improved artificial disc replacements (ADRs), including various embodiments that restrict spinal extension, rotation, translation, and/or lateral bending. In one disclosed configuration, rotation and translocation are limited by a “spoon-on-spoon” type of cooperation. Wedge or trapezoid-shaped ADRs are also presented to preserve lordosis. Fasteners may be used to fix the ADR to upper and lower vertebrae. An optional lip may additionally be provided to prevent the trapping of soft tissue during the movement from a flexion to neutral position.
The present invention extends such teachings through total disc replacements (TDRs) that more closely replicate the kinematics of a natural disc. The preferred embodiments feature two or more fixed centers of rotation (CORs) and an optional variable COR (VCOR) as the ADR translates from a fixed posterior COR to a more anterior COR. The multiple CORs permit a TDR with a posterior COR that lies posterior to the COR of the TDR to facilitate normal disc motion. The use of two or more CORs allow more flexion and more extension than permitted by the facet joints and the AF. Artificial facet joint-like components may also be incorporated into the design to restrict excessive translation, rotation, and/or lateral bending.
FIG. 1 is a sagittal cross section of a TDR 10 according to the invention having three fixed CORs 12, 14, and 16. Articulation occurs at the posterior COR 12 when the spine is in a neutral to extended position. FIG. 2 is a sagittal cross section of the TDR drawn in FIG. 1 with the ADR 10 extended 5 degrees, more or less. FIG. 3 is a sagittal cross section of the TDR drawn in FIG. 1 in various degrees of flexion. As illustrated in the figure, the COR migrates anteriorly from a more posterior COR to a more anterior COR as the TDR is flexed.
FIG. 4 is sagittal cross section of another embodiment TDR 110 of the invention having an anterior COR 112 and a posterior COR 114. In this case, the TDR 110 articulates at the posterior COR 114 with the TDR in neutral to extended position. FIG. 5 is a sagittal cross section of the TDR 110 drawn in FIG. 4 in a flexed position. Note that the superior TDR endplate 110a translates forward from the posterior COR to the anterior COR as the ADR 110 moves from a neutral or extended position to a flexed position. FIGS. 6A and 6B are a view of the articulating surfaces of the TDR 110 drawn in FIG. 4. The inferior TDR endplate 110b is shown in FIG. 6A, and the inferior surface of the superior TDR endplate 110a is shown in FIG. 6B.
FIG. 7 is a sagittal cross section of a further embodiment of the invention, including an anterior and a posterior COR 212 and 214, respectively. The design also includes novel artificial facet joint-like components that prevent excessive translation, rotation, or lateral bending. FIG. 8 is a sagittal cross section of the TDR 210 drawn in FIG. 7 in a more flexed position. The drawing illustrates a gap between the artificial facet joint-like portions of the device. FIG. 9 is a view of the articulating surfaces of the TDR 210 drawn in FIG. 7. The superior surface of the inferior TDR endplate 210b is drawn on the left. FIG. 10 is an oblique view of the assembled TDR 210 drawn in FIG. 7. This embodiment of the TDR 210 illustrates the use of a toroidal patch and two spherical patches to form the anterior articulating surface of the lower plate. The novel toroidal-spherical surface facilitates lateral bending.
FIG. 11A is a view of the anterior side of a cervical embodiment of the TDR 210 drawn in FIG. 7. Screws can be inserted through the holes in the TDR 210 to attach the TDR 210 to the vertebrae. A reversible locking mechanism can be used to prevent the screws from backing out of the vertebrae. FIG. 11B is a view of the lateral side of the TDR 210 drawn in FIG. 11A. FIG. 11C is a view of the anterior of the TDR 210 drawn in FIG. 11A. The superior surface of the inferior component of the TDR is drawn on the left.
FIG. 12A is a sagittal cross section of another embodiment TDR 310 wherein, in contrast to the embodiment of FIG. 7, the articulating surfaces of the anterior and/or the posterior CORs are not congruent. The use of non-congruent articulating surfaces uncouples translation from rotation. ADRs with non-congruent joint surfaces allow greater spinal flexion and extension without corresponding subluxation of the vertebrae. The spherical projections from the upper and lower ADR endplates 310a and 310b can cooperate to prevent the upper ADR endplate 310a from translating posteriorly over the inferior ADR endplate 310b. The drawing illustrates the different radius of curvature of the components forming the joint in the posterior aspect of the ADR.
FIG. 12B is a sagittal cross section of the embodiment of the ADR 310 drawn in FIG. 12A in a flexed position. The drawing illustrates the different radius of curvature of the components forming the joint in the anterior aspect of the ADR 310. FIG. 12C is a view of the side of the ADR 310 drawn in FIG. 12A. Artificial facet joint-like components, similar to those drawn in FIG. 7, prevent excessive forward translation of the upper ADR endplate relative to the lower ADR endplate. The artificial fact joint-like components can also limit axial rotation and lateral bending.
FIG. 13A is a view of the side of the ADR 310 drawn in FIG. 12A, with modular shims. Modular shims can be used to increase lordosis, or wedge shape, of the ADR 310. The modular shims can be attached to the top of the superior ADR endplate 310a and/or the bottom of the inferior ADR endplate 310b. The shims could fasten to the keels of the ADR 310. Alternatively the shims could attach to another part of the ADR endplates 310a and 310b. Lastly, the shims could simply lay on the ADR endplates 310a and 310b. The shim inventory would include shims with different thickness and different angles. FIG. 13B is an exploded view of the embodiment of the ADR drawn in 13A.
Although surfaces depicted herein are shown as being ‘congruent,’ this is not necessary according to the invention. For example, a concave surface may have a radius of curvature that is larger than the radius of curvature of an articulating convex surface such that the two surfaces are not in direct or intimate contact at all times. Both symmetrical and asymmetrical joints may also be used. A portion of the back of the posterior joint may be removed to move the posterior COR further posterior and to increase the surface area of the posterior joint by increasing the radius of the surface. The articulating surface may be formed by a toroidal region and a spherical region, in this and other embodiments non-spherical surfaces may also be used to permit translation, rotation or other movements between more controlled articulations. TDRs according to the invention may be used in the cervical, thoracic, or lumbar spine.
ADR/TDRs according to the invention may also be composed of various materials. For example, the components may be constructed of a metal such as chrome cobalt or a ceramic such as aluminum oxide. The novel TDR can also be made of a metal or ceramic coated with a harder or softer second material. That is, one or both of the components may be a metal coated with a ceramic, or a metal or ceramic coated with a diamond-like material or other hardened surface. Alternatively, one or both of the components may be coated with a polymeric (i.e., polyethylene) surface or liner.

## Claims

1. A method of implanting an artificial disc replacement (ADR) comprising:
inserting first and second components into an intervertebral disc space defined by vertebral bodies of first and second vertebrae so that vertebral-body contact surfaces of the first and second components contact respective vertebral bodies of the first and second vertebrae, the first and second components each having articular surfaces disposed opposite their respective vertebral-body contact surfaces; and
rotating the first and second components relative to each other about first and second centers of rotation, at least one of the first and second centers of rotation being positioned external to the intervertebral disc space.

2. The method of claim 1, wherein the first component is translatable relative to the second component.

3. The method of claim 1, wherein the first center of rotation is aligned with an anterior portion of the ADR, and the second center of rotation is aligned with a posterior portion of the ADR.

4. The method of claim 1, wherein the inserting step includes inserting a keel extending from one of the first and second components into an opening in the respective vertebral body.

5. The method of claim 1, wherein rotating the first and second components includes allowing the first and second components to rotate under natural forces applied by a spinal column that is comprised of the first and second vertebrae.

6. The method of claim 1, wherein rotating the first and second components includes contacting the articular surface of the first component with the articular surface of the second component.

7. The method of claim 1, wherein the articular surfaces of the first and second components each include a concave surface.

8. The method of claim 1, wherein, after the inserting step, the first component is positioned superior to the second component, the first center of rotation is positioned superior to the vertebral contact surface of the first component, and the second center of rotation is positioned inferior to the vertebral contact surface of the second component.

9. A method of implanting an artificial disc replacement (ADR) comprising:
inserting a first component into an intervertebral disc space so that a vertebral-body contact surface thereof contacts a vertebral body of a first vertebra and so that a keel extending from the vertebral-body contact surface extends into an opening within the vertebral body of the first vertebra;
inserting a second component into an intervertebral disc space so that a vertebral-body contact surface thereof contacts a vertebral body of a second vertebra and so that a keel extending from the vertebral-body contact surface of the second component extends into an opening within the vertebral body of the second vertebra; and
allowing the first and second components to rotate relative to each other about first and second centers of rotation, the first and second centers of rotation being at least partially defined by articular surfaces of the first and second components, and the first center of rotation being positioned external to the disc space.

10. The method of claim 9, wherein the articular surfaces of the first and second components each include a concave surface.

11. The method of claim 9, wherein after the inserting step, the first component is positioned superior to the second component and the first center of rotation is positioned superior to the vertebral contact surface of the first component.

12. The method of claim 9, wherein the first and second components are allowed to rotate under natural forces applied to the components via the first and second vertebrae.

13. The method of claim 9, wherein the vertebral-body contact surface of the first component is angled relative to the vertebral-body contact surface of the second component by a degree sufficient to correspond to a natural lordosis between the vertebral bodies.

14. A method of implanting an artificial disc replacement (ADR) comprising:
inserting superior and inferior components into an intervertebral disc space defined by vertebral bodies of superior and inferior vertebrae so that vertebral-body contact surfaces of the superior and inferior components contact respective vertebral bodies of the superior and inferior vertebrae; and
rotating the first and second components relative to each other about a plurality of centers of rotation which are at least partially defined by articular surfaces of the superior and inferior components, and wherein at least one of the centers of rotation is either positioned above the vertebral-body contact surface of the superior component or below the vertebral-body contact surface of the inferior component.

15. The method of claim 14, wherein the articular surfaces of the superior and inferior components each include a concave surface.

16. The method of claim 14, wherein the superior and inferior components are allowed to rotate under natural forces applied to the components via the first and second vertebrae.

17. The method of claim 14, wherein the vertebral-body contact surface of the superior component is angled relative to the vertebral-body contact surface of the inferior component by a degree sufficient to correspond to a natural lordosis between the vertebral bodies.

18. The method of claim 14, wherein rotating the first and second components includes engaging the articular surface of the first component with the articular surface of the second component.