# Patent

## Title
Hybrid intervertebral spinal fusion implant

## Abstract

An implant made of at least two different materials. The implant may include materials with varying radiolucency and mechanical properties. Such a hybrid implant may offer controlled radiographic visibility and optimized structural properties for implant placement, including placement for use in spinal arthrodesis.

## Background
CROSS REFERENCE
This application claims priority from U.S. Provisional Patent Application Ser. No. 60/720,555, filed on Sep. 26, 2005, entitled “Hybrid Intervertebral Spinal Fusion Implant.” The following applications also claim priority to the above referenced provisional application and are related to the present application. They are incorporated by reference herein:
U.S. Utility patent application Ser. No. 11/527,121, filed on Sep. 26, 2006 and entitled “Transforaminal Hybrid Implant;” and
U.S. Utility patent application Ser. No. 11/527,123, filed on Sep. 26, 2006 and entitled “Anterior Hybrid Implant.”


TECHNICAL FIELD
The present invention relates generally to the field of medical implants and methods, and more specifically to interbody spinal implants which may be adapted for placement into an implantation space created across the height of a disc space between two adjacent vertebral bodies for the purpose of correcting disease, dysfunction, or degeneration at that interspace, and any related methods. The spinal implants may be made of a plurality of implant materials which bear differing degrees of radiographic lucency. These materials may include bone and may or may not be resorbable. The implants of some embodiments are adapted such that radiographic visualization of operative placement and eventual bone healing can be observed.
BACKGROUND
Implants for placement in the intervertebral space between adjacent vertebral bodies in the spine come in a wide range of shapes and sizes. These implants are usually made entirely of one material, although the type of material can vary significantly between specific implants. Such implants for use in human spinal surgery include implants made entirely of metals, such as titanium or stainless steel, or synthetic radiolucent materials such as carbon-carbon composites or poly-ether-ether-ketone (PEEK). Implants may have a structure designed to promote fusion across adjacent vertebral bodies by allowing bone to grow through and around the implant. The operative placement of intervertebral implants is optimized by radiographic opacity. However, a relatively radiolucent implant material optimizes postoperative evaluation of bone growth and fusion across an intervertebral space. While these implants may contain marking beads or radio opaque markers they do not structurally benefit from radio opaque materials. In some configurations, metals, some of which are opaque on radiographs, provide greater strength and resistance to impaction during implantation. Metallic implants may offer reduced wall thickness of structural components and offer increased volume for bone graft and other agents within an implant.
As it is desirable to take advantage of benefits of radiolucent and radio-opaque materials in an implant, there exists a need for an improved implant made of different structural materials with different properties of radiographic appearance. For some implants, it is desirable to provide optimization of mechanical properties, while permitting generous bone filling and bone through-growth. These characteristics may be applied in some embodiments in combination with an ability to radiographically determine bone-implant interaction and bone growth into and around the implant.
SUMMARY
Embodiments of the invention may include an artificial interbody spinal fusion implant made of structural materials with varying radiolucency and mechanical characteristics. Implants may be provided for insertion at least in part into an implantation space formed across the height of a disc space between adjacent vertebral bodies of a human spine. The implant of some embodiments consists of at least two radiographically distinct imaging materials: a radiolucent portion, and a radio-opaque portion. The radio-opaque materials of some embodiments are arranged toward the vertebral endplates with minimal obstruction to radiographic visualization through the implant from anterior to posterior and/or from lateral directions. Embodiments of the implant may include upper and lower portions adapted to be placed within the intervertebral space to contact and support the adjacent vertebral bodies. Upper and lower portions of the implant may include at least one opening in communication with one another and adapted to hold bone growth promoting material and/or bone graft for permitting the growth of bone from vertebral body to vertebral body through the implant. Embodiments of the invention include an artificial interbody spinal implant containing at least two different materials for insertion at least in part into an implantation space formed across the height of a disc space between adjacent vertebral bodies of a spine. Implant embodiments may employ materials that bear a structural role in the design of the implant, and at least a portion of a leading end of the implant may have a reduced height to facilitate insertion of said implant between the two adjacent vertebral bodies. Implants may have a maximum length less than and approximating the posterior to anterior or right to left length of the vertebral bodies. Some embodiments also include a bone engaging surface formed on the exterior of at least the upper and lower portions for engaging the adjacent vertebral bodies, such as one or more protrusions, ratchets, spikes, roughened surfaces or knurling. Embodiments of the implant may be combined with a bone growth or bone healing promoting material such as, but not limited to, bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone forming cell differentiating substance, bone morphogenetic protein, hydroxyapatite, and gene therapy material leading to the production of bone. Embodiments of the implant may also be combined with a therapeutic substance for the treatment of infection, tumor or other pathologic process. In some embodiments of the invention, one component material is relatively, or absolutely radiolucent. In some embodiments of the invention, one component material is radio-opaque. One component material of the implant may be at least in part resorbable. In some embodiments, at least a portion of an implant is treated to promote bone in-growth between the implant and adjacent vertebral bodies. Embodiments of the implant may be used in combination with at least one spinal fixation implant. Embodiments of the implant may include a hollow interior and at least one area for attachment or interaction with an insertion device for surgical placement or removal from the intervertebral space. Upper and lower surfaces of some embodiments of the implant may include a plurality of openings. Embodiments of the implant may be designed to be inserted adjacent to a second implant into a disc space between adjacent vertebral bodies, the second implant being of identical or differing shape. At least one opening may be between the leading and trailing ends of embodiments of the implant. Upper and lower portions or surfaces of embodiments of the implant may be at least in part generally parallel to one another or may be configured with an angular relationship to each other for allowing angulation of adjacent vertebral bodies relative to each other.
Another embodiment of the invention is an intervertebral implant for promoting fusion between adjacent vertebral bodies. The implant may include a first body made at least in part of a first material, the first body having an inferior laterally extending member, a support coupled to and extending superiorly away from the inferior laterally extending member, and a superior laterally extending member coupled to the support. The implant may also include a second body made at least in part of a second material, the second body configured to fit at least partially between the inferior laterally extending member and the superior laterally extending member.
Yet another embodiment of the invention is an intervertebral implant for promoting fusion between two adjacent vertebral bodies. The implant may include first and second radio-opaque plates for engaging with opposing endplates of the adjacent vertebral bodies, the first and second plates being constructed to form a space therebetween, and first and second radiolucent blocks placed between the first and second plates at opposite lateral sides of the space. An interior void may be formed in the space between the first and second plates, the interior void being partially enclosed on at least two sides by the first and second radiolucent blocks.
Still another embodiment of the invention is an intervertebral implant with a lateral dimension, an anterior to posterior dimension, and an inferior to superior vertical dimension, the implant for placement between adjacent vertebral bodies. The implant may include an inferior laterally extending member, a superior laterally extending member, and a substantially radiolucent body configured to fit at least partially between the inferior laterally extending member and the superior laterally extending member. Two or more supports coupled to and extending between the inferior laterally extending member and the superior laterally extending member may also be included, and a relative alignment among the two or more supports, as viewed radiographically from at least one of anterior, posterior, and lateral sides, indicates a rotational position of the implant about a vertical axis.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of two adjacent vertebral bodies in a lumbar spine with an implantation space formed across the height of the spinal disc space.
FIG. 2 is a top plan view of a vertebral body in a lumbar spine with an implantation space formed through a posterior approach.
FIG. 3 is a side perspective view of the implantation space of FIG. 2.
FIG. 4 is a perspective view of an implantation space formed through an anterior approach.
FIG. 5 is a top plan view of a vertebral body in the lumbar spine with an embodiment of an implant positioned in the implantation space of FIG. 2.
FIG. 6 is a side view of two adjacent vertebral bodies with the implant of FIG. 5 positioned in the implantation space of FIG. 2 through a posterior approach.
FIG. 7 is a side view of two adjacent vertebral bodies with an implant positioned in the implantation space of FIG. 2 through an anterior approach.
FIG. 8 is a top plan view of the implant of FIG. 5
FIG. 9 is a rear perspective view of the implant of FIG. 5.
FIG. 10 is a side view of the implant of FIG. 5.
FIG. 11 is a rear view of the implant of FIG. 5,
FIG. 12 is a rear perspective view of another embodiment of an implant for use in the implantation space of FIG. 2.
FIG. 13 is a rear view of the implant of FIG. 12.
FIG. 14 is a side view of the implant of FIG. 12.
FIG. 15 is a rear perspective view an embodiment of an implant suited for anterior placement into a cervical or lumbar intervertebral disc space.
FIG. 16 is a top plan view of the implant of FIG. 15.
FIG. 17 is a side view of the implant of FIG. 15.



DETAILED DESCRIPTION
The following description is intended to be representative only and not limiting and many variations can be anticipated according to these teachings, which are included within the scope of this inventive teaching. Reference will now be made in detail to embodiments of this invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
FIGS. 1-3 show an implantation space 100 formed across the height of a spinal disc D between vertebral bodies V in the lumbar spine. In other embodiments, the vertebral bodies may be bodies of the cervical or thoracic spine as well. It is understood that numerous methods exist and that any method and instrumentation designed for the purpose may be applied to prepare the desired implantation space and perform disc and soft tissue removal in such a manner as to be adapted to receive the implants of the present invention. It is also understood that implantation space preparation commonly leaves residual disc material D prior to implant placement.
FIG. 3 shows the implantation space 100, which has been prepared by partial disc and soft tissue removal adjacent to the vertebral body V. The preparation in FIG. 3 is shown as a posterior lumbar surgical approach, and the opening O into the disc space from the posterior is shown. The opening O may also be an opening prepared for transforaminal or oblique surgical approaches. Residual portions P of the vertebral pedicles are also shown.
FIG. 4 shows the implantation space 100, which has been prepared by partial disc and soft tissue removal adjacent to the vertebral body V. The preparation in FIG. 4 is shown as an anterior surgical approach and the entrance E into the disc space from the anterior is shown. This representation can reflect a cervical, thoracic, or lumbar spinal intervertebral space preparation.
FIG. 5 shows a unilateral implant 200 seated in the implantation space 100 in accordance with an embodiment of the present invention. Bone graft material BG is shown anterior to the unilateral implant 200, as well as within a central void 210 of the unilateral implant 200.
FIG. 6 shows a unilateral implant 200 seated in the implantation space 100. Bone graft material BG is shown anterior to the unilateral implant 200 but posterior to remaining disc D, as well as within the central void 210 of the unilateral implant 200.
FIG. 7 shows an anterior implant 400 seated in the implantation space 100. Bone graft material BG is shown within a cavity 480 of the anterior implant 400.
FIG. 8 shows the unilateral implant 200 with an anterior aspect 202 and a posterior aspect 204. The central void 210 is shown. Traversing support structures 220, 220′ extend from anterior 202 to posterior 204 aspects of the implant. In the lateral aspects of the unilateral implant 200 radiolucent blocks 240, 240′ are shown, each with a central cavity 242, 242′.
FIG. 9 shows the unilateral implant 200 as described in FIG. 8. The view from a posterior perspective shows the central void 210, the radiolucent blocks 240, 240′ and posterior support columns 222, 222′ which extend from an inferior aspect 260 to a superior aspect 264 of the implant.
FIG. 10 shows the unilateral implant 200 as described in FIG. 8 from a lateral view. The radiolucent block 240 is shown positioned between the superior aspect 264 and the inferior aspect 260 of the implant. A posterior support column 222 and an anterior support column 223 between the superior aspect 264 and inferior aspect 260 are shown. In a lateral projection, anterior 202 and posterior 204 aspects to the implant are noted.
FIG. 11 shows a posterior view of the implant as described in FIGS. 8 and 9 without appearance of the radiolucent blocks 240, 240′, in order to show radiographic appearance. Only the posterior support columns 222, 222′ extending between the inferior aspect 260 and the superior aspect 264 of the implant are visualized radiographically due to the selected radio-opaque nature of the material implemented in this embodiment. Anterior support columns 223, 223′ are hidden behind posterior support columns 222, 222′ when the unilateral implant 200 is visualized radiographically directly from the posterior.
FIG. 12 shows another embodiment of the invention with a center-support implant 300 in rear perspective view. A central volume 310, and radiolucent lateral blocks 340, 340′, as well as anterior support structure 324, and posterior support structure 322 are noted.
FIG. 13 shows a posterior view of the implant as described in FIG. 12 without appearance of the radiolucent lateral blocks 340, 340′ in order to show radiographic appearance. Only the posterior support structure 322, which overlaps in this view the anterior support structure 324, seen in FIG. 12, is visualized radiographically between the inferior portion 360 and the superior portion 364 of the implant due to the selected radio-opaque nature of the material implemented in this embodiment.
FIG. 14 shows the center-support implant 300 as described in FIG. 12 from a lateral view. The radiolucent lateral block 340 is shown positioned between the superior portion 364 and the inferior portion 360 of the implant. In this lateral projection the anterior support structure 324 and posterior support structure 322 of the implant are noted.
FIG. 15 illustrates an anterior implant 400. In some embodiments, the anterior implant 400 may be placed through an anterior surgical approach. However, the anterior implant 400 may also be placed by other surgical approaches such as, but not limited to, an anterior-oblique approach or a lateral approach. A large central strut 410 made of radiolucent material is shown traversing the implant. Upper rim 420 and lower rim 422 are attached to the central strut 410 and further supported and connected to one another through supportive structures 440, 442, 444, 446. Openings through the sides of the implant are noted 450, 452, 454, 456. These openings may permit for the growth of bone through and into anterior implant 400, though the invention is not so limited.
FIG. 16 shows a top plan view of the anterior implant 400 as described in FIG. 15. The large central strut 410 is noted. Two cavities 480,480′ within the anterior implant 400 are shown on either side of the strut 410. These cavities may permit for the growth of bone through and into anterior implant 400, though the invention is not so limited.
FIG. 17 shows a lateral view of the anterior implant 400 as described in FIGS. 15 and 16. Upper rim 420 and lower rim 422 are shown, as is the lateral view of the central strut 410. Given the radiolucent nature of the central strut 410, on radiographic visualization only the upper rim 420 and lower rim 422 as well as radio-opaque supportive structures 440,442 would be noted. The remaining two supportive structures 444,446 noted in FIG. 15 are obscured in a lateral view by the supportive structures 440,442. Further, angulation between the upper rim 420 and lower rim 422 may facilitate insertion of anterior implant 400 between the two adjacent vertebral bodies and permit control of sagittal plane intervertebral alignment.
While the implants are intended primarily for use in spinal fusion, it is appreciated that they may be modified or adapted to receive fusion promoting substances and/or materials within them such as, but not limited to cancellous bone, bone derived products, chemotherapeutic agents, antimicrobial agents, or others. In some embodiments, the implants consists of materials such as, but not limited to, titanium and its alloys, ASTM material, cobalt chrome, tantalum, ceramic, poly-ether-ether-ketone (PEEK), various plastics, plastic composites, carbon fiber composites, coral, and can include artificial materials which are at least in part bioresorbable. The radiographic appearance of the structural materials employed in the implants are intended to be of varying nature such that optimal visualization of implant placement, implant-bone interfaces and/or bone ingrowth and through-growth can be achieved.
While the descriptions reveal various relationships, parallel or not, of upper to lower surfaces of the implants, it should be noted that deliberate angulation between surfaces relative to each other is possible. Subsequently, when implanted into the spine, such implants permit position of the adjacent vertebral bodies in angular relationship to each other to restore the natural curvature of the spine, such as lordosis for example. It should also be noted that significant variations in shape of the implants are possible including but not limited to: kidney shaped, rounded, wedge shaped, cylindrical, trapezoidal, rectangular, oblong, and oval.
Outer surfaces may contain threading or particular unevenness for improved insertion or anchorage into surrounding tissues or bone. In any of the embodiments of the present invention, the implants may include, be made of, treated, coated, filled, used in combination with, or have a hollow space or opening for containing artificial or naturally occurring materials and/or substances suitable for implantation in the human spine. These materials, and/or substances, may include any source of osteogenesis, bone growth promoting materials, bone, bone derived substances or products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic proteins, hydroxyapatite, genes coding for the production of bone, and bone including, but not limited to, cortical bone, antibiotics, cancer treating substances, infection treating substances or other disease treating substances. The implant can include, at least in part materials that are bioabsorbable and/or resorbable in the body. The implants of the present invention can be formed of a porous material or can be formed of a material that intrinsically participates in the growth of bone between adjacent vertebral. At least a portion of the implant may be treated to promote bone ingrowth between the implant and the adjacent vertebral bodies.
The implant of the present invention may be used in combination with a spinal fixation device such as any device, regardless of material, that can be inserted into any portion of the spine, such as but not limited to interbody spinal implants, structural bone grafts, mesh, cages, spacers, staples, bone screws, plates, rods, tethers of synthetic material or wires, or other spinal fixation instrumentation. While the invention has been described with reference to particular embodiments, it will be appreciated by those of ordinary skill in the art that various modifications can be made to the invention itself without departing from the spirit and scope thereof. All changes and modifications that are within the spirit of the invention are hereby anticipated and claimed.

## Claims

1. An intervertebral implant for promoting fusion between adjacent vertebral bodies comprising:
a first body made at least in part of a first material, the first body comprising:
an inferior laterally extending member having a first anterior aspect and a first posterior aspect separated at least in part by a central void and joined together at least by respective end members,
a pair of vertical supports coupled to and extending superiorly away from the inferior laterally extending member and the central void being defined between the pair of vertical supports, and
a superior laterally extending member having a second anterior aspect and a second posterior aspect separated at least in part by the central void and joined together by respective second side members, wherein the superior laterally extending member is coupled to the pair of vertical supports;
a first horizontal support extending from the first anterior aspect to the first posterior aspect of the inferior laterally extending member, a second horizontal support extending from the first anterior aspect to the first posterior aspect of the inferior laterally extending member, a third horizontal support extending from the second anterior aspect to the second posterior aspect of the superior laterally extending member, a fourth horizontal support extending from the second anterior aspect to the second posterior aspect of the superior laterally extending member, wherein the first and third horizontal supports are aligned with a first vertical support of the pair of vertical supports and the second and fourth horizontal supports are aligned with a second vertical support of the pair of vertical supports, wherein the pair of vertical supports define an anterior access opening and a posterior access opening to the central void, the first and second horizontal supports define an inferior access opening to the central void, and the third and fourth horizontal supports define an superior access opening to the central void; and

a second body made at least in part of a second material that is substantially radiolucent, the second body configured to fit in the central void at least partially between the inferior laterally extending member and the superior laterally extending member and at least partially between the pair of supports, wherein the pair of supports are aligned with one another so that one of the supports is obscured by the other of the supports when viewed radiographically from at least one of anterior, posterior, and lateral sides, to indicate a rotational position of the implant about a vertical axis.

2. The intervertebral implant of claim 1 wherein the first material is a biocompatible metal.

3. The intervertebral implant of claim 1 wherein the first material is titanium.

4. The intervertebral implant of claim 1 wherein the first material is radiographically detectable.

5. The intervertebral implant of claim 1 wherein the first material is radio-opaque.

6. The intervertebral implant of claim 1 wherein the inferior laterally extending member is a plate configured at least in part to contact an inferior vertebral body.

7. The intervertebral implant of claim 1 wherein the inferior laterally extending member includes one or more of protrusions, ratchets, spikes, roughened surfaces, and knurling directed toward an inferior vertebral body.

8. The intervertebral implant of claim 1 wherein the pair of supports each comprises a column that provides structural support between the inferior laterally extending member and the superior laterally extending member.

9. The intervertebral implant of claim 1 wherein the superior laterally extending member is a plate configured at least in part to contact a superior vertebral body.

10. The intervertebral implant of claim 1 wherein the superior laterally extending member includes one or more of protrusions, ratchets, spikes, roughened surfaces, and knurling directed toward a superior vertebral body.

11. The intervertebral implant of claim 1 wherein the second material is a biocompatible polymer.

12. The intervertebral implant of claim 1 wherein the second material is PEEK.

13. The intervertebral implant of claim 1 wherein the second material is radiographically detectable.

14. The intervertebral implant of claim 1 wherein the second material is radiolucent.

15. The intervertebral implant of claim 1 wherein the second material is less radiographically detectable than the first material.

16. The intervertebral implant of claim 1 further comprising a bone growth promoting substance between the inferior laterally extending member and the superior laterally extending member.

17. An intervertebral implant for promoting fusion between two adjacent vertebral bodies comprising:
first and second opposing radio-opaque plates, the first plate having a lower surface configured for engaging a first endplates of the adjacent vertebral bodies and the second plate having an upper surface configured for engaging a second endplate of the adjacent vertebral bodies, the first and second plates each including an anterior aspect and a posterior aspect separated by a first opening, a first support structure extending vertically between the anterior aspects of the first and second plates adjacent a first lateral side of the first and second plates, a second support structure extending vertically between the anterior aspects of the first and second plates adjacent a second lateral side of the first and second plates, a third support structure extending vertically between the posterior aspects of the first and second plates adjacent the first lateral side of the first and second plates, a fourth support structure extending vertically between the posterior aspects of the first and second plates adjacent the second lateral side of the first and second plates, the first and second plates and the first and third support structures being constructed to form a first space therebetween, the first and second plates and the second and fourth support structures being constructed to form a second space therebetween, the anterior and posterior aspects of each respective plate being connected together at each opposing end of the first and second plates and defining a cavity between the ends of the first and second plates and respective surfaces of the first, second, third, and fourth support structures;
first and second radiolucent blocks placed in the respective cavities between the first and second plates at opposite ones of the first and second lateral sides of the first and second plates;
wherein an interior void is formed in the first and second spaces between the first and second plates and the first, second, third and fourth support structures, the first and second spaces being partially enclosed on at least two sides by the first and second radiolucent blocks and the interior void opening through the first and second plates between the first and second support structures to form a front opening and a rear opening into the interior void, and the interior void opening through the anterior and posterior aspects of the first and second plates between the first and second radiolucent blocks to form a lower opening and an upper opening into the interior void.

18. The intervertebral implant of claim 17 wherein the first and second radio-opaque plates are at least in part made from titanium.

19. The intervertebral implant of claim 17 wherein the first and second radiolucent blocks are at least in part made from PEEK.

20. The intervertebral implant of claim 17 wherein at least one of the first and second radiolucent blocks includes a hole through the radiolucent block, wherein the holes are in alignment with each cavity in the first and second plates.

21. The intervertebral implant of claim 20 further comprising a bone growth promoting substance in one or both of the holes through the radiolucent blocks.

22. The intervertebral implant of claim 17 wherein the interior void extends between the adjacent vertebral bodies when the implant is implanted.

23. The intervertebral implant of claim 17 further comprising a bone growth promoting substance in the interior void.

24. An intervertebral implant with a lateral dimension, an anterior to posterior dimension, and an inferior to superior vertical dimension, the implant for placement between adjacent vertebral bodies comprising:
an inferior laterally extending member having a first central opening defined by a first anterior aspect and a first posterior aspect oriented around a first outer perimeter of the inferior laterally extending member, a first end opening defined by a first horizontal support structure extending from the first anterior aspect to the first posterior aspect and a first rounded end of the inferior laterally extending member, a second end opening defined by a second horizontal support structure extending from the first anterior aspect to the first posterior aspect and a second opposite rounded end of the interior laterally extending member;
a superior laterally extending member having a second central opening defined by a second anterior aspect and a second posterior aspect oriented around a second outer perimeter of the superior laterally extending member, a third end opening defined by a third horizontal support structure extending from the second anterior aspect to the second posterior aspect and a third rounded end of the superior laterally extending member, a fourth end opening defined by a fourth horizontal support structure extending from the second anterior aspect to the second posterior aspect and a fourth opposite rounded end of the superior laterally extending member;
a substantially radiolucent body configured to fit at least partially between the inferior laterally extending member and the superior laterally extending member; and
two or more vertical supports coupled to and extending between the inferior laterally extending member and the superior laterally extending member in alignment with the first, second, third, and fourth horizontal support structures respectively, the two or more vertical supports including a central cavity extending therebetween and the substantially radiolucent body is configured to fit at least partially between the two or more supports, wherein the two or more vertical supports define a front opening and a rear opening in alignment with the first and second central openings in the inferior and superior laterally extending members;
wherein a relative alignment among the two or more supports, as viewed radiographically from at least one of anterior, posterior, and lateral sides, indicates a rotational position of the implant about a vertical axis.