`Michelson
`
`USOO624177OB1
`(10) Patent No.:
`US 6,241,770 B1
`(45) Date of Patent:
`Jun. 5, 2001
`
`(54) INTERBODY SPINAL FUSION IMPLANT
`HAVING AN ANATOMICALLY CONFORMED
`TRALING END
`
`(76) Inventor: Gary K. Michelson, 438 Sherman
`Canal, Venice, CA (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(*) Notice:
`
`(21) Appl. No.: 09/263,266
`(22) Filed:
`Mar. 5, 1999
`(51) Int. Cl." .................................................... A61F 2/44
`(52) U.S. Cl. ........................................................... 623/17.11.
`(58) Field of Search ................................................. 623/17
`(56)
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`(Nov. 1985).
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`Repair-Clinical Evaluation of Bone Union and Graft Incor
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`(List continued on next page.)
`Primary Examiner-David H. Willse
`(74) Attorney, Agent, or Firm Martin & Ferraro, LLP
`(57)
`ABSTRACT
`An interbody Spinal fusion implant adapted for placement at
`least in part across an intervertebral Space formed acroSS a
`disc Space between two adjacent vertebral bodies and for
`penetrating engagement into each of those vertebral bodies,
`the implant having a trailing end adapted to sit upon and not
`protrude from the anterolateral peripheral rim of bone of the
`vertebral body.
`
`104 Claims, 9 Drawing Sheets
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
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`US 6,241,770 B1
`Page 2
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`* cited by examiner
`
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`U.S. Patent
`
`Jun. 5, 2001
`
`Sheet 1 of 9
`
`US 6,241,770 B1
`
`
`
`FIG. 3
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`U.S. Patent
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`Jun. 5, 2001
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`Sheet 2 of 9
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`US 6,241,770 B1
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`FIG. 4
`
`H
`
`FIG. 5
`PRIOR ART
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`g
`
`frie
`
`
`
`Ole OC
`
`
`
`
`
`XY
`FIG. 6A
`PRIOR ART 36OOOOK
`2 - QS
`
`
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`U.S. Patent
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`Jun. 5, 2001
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`Sheet 3 of 9
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`US 6,241,770 B1
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`F/G. 6B
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`10Of
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`Jun. 5, 2001
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`Sheet 4 of 9
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`US 6,241,770 B1
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`Jun. 5, 2001
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`Sheet 5 of 9
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`US 6,241,770 B1
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`FIG. 10
`
`
`
`
`
`LCY
`
`M
`
`
`
`FIG 11
`PRIOR ART
`
`
`
`(46%
`
`
`
`as as ess as ess
`
`
`
`W. YY YY YY YW YW YW YW YW Y
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`Sheet 6 of 9
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`US 6,241,770 B1
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`
`§§
`L-Q
`
`FIG.
`
`
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`2D 1
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`Jun. 5, 2001
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`Sheet 7 of 9
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`US 6,241,770 B1
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`
`
`
`
`S
`S
`
`s
`S
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`Jun. 5, 2001
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`Sheet 8 of 9
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`US 6,241,770 B1
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`
`
`
`
`S
`S
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`S.
`S
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`FIG. 15A
`
`
`
`800
`
`FIG. 15B
`MLA
`SOO
`
`F/G, 16A
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`FIG. 16B
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`US 6,241,770 B1
`
`1
`INTERBODY SPINAL FUSION MPLANT
`HAVING AN ANATOMICALLY CONFORMED
`TRALING END
`
`2
`FIG. 3 is a top plan view of a fifth lumbar level vertebral
`body V shown in relationship anteriorly with the iliac
`arteries and veins referred to by the designation “IA-V”. The
`location of these fragile blood vessels along the anterior
`aspects of the lumbar vertebrae makes it imperative that no
`hardware protrude dangerously therefrom where the vessels
`could be endangered.
`Implants for use in human spinal Surgery can be made of
`a variety of materials. Such as Surgical quality metals,
`ceramics, plastics and plastic composites, cortical bone and
`other materials Suitable for the intended purpose, and further
`may be absorbable and or bioactive as in being Osteogenic.
`Fusion implants preferably have a structure designed to
`promote fusion of the adjacent vertebrae by allowing bone
`to grow through the implant from vertebral body to adjacent
`vertebral body to thereby fuse the adjacent vertebrae. This
`type of implant is intended to remain indefinitely within the
`patient’s spine or if made of bone or other resorbable
`material to eventually be replaced with the patient's bone.
`Michelson, Ray, Bagby, Kuslich, and others have taught
`the use of hollow, threaded perforated cylinders to be placed
`acroSS a disc Space between two adjacent vertebrae in the
`human Spine to encourage interbody Spinal fusion by the
`growth of bone from one vertebra adjacent a disc to the other
`Vertebra adjacent that disc through Such implants.
`Michelson, Zdeblick and others have also taught the use of
`Similar devices that either have truncations of their sides
`Such that they are not complete cylinders, and/or are tapered
`along their longitudinal axis much like a cylinder which has
`been split longitudinally and then wedged apart. All of these
`implants have in common opposed arcuate Surfaces for
`penetrably engaging into each of the vertebral bodies adja
`cent a disc space to be fused. Such implants now in common
`use throughout the Spine, may be used individually or
`inserted acroSS the disc Space in Side-by-side pairs, and may
`be insertable from a variety of directions.
`It is commonly held by Surgeons skilled in the art of spinal
`fusion that the ability to achieve Spinal fusion is inter alia
`directly related to the vascular Surface area of contact over
`which the fusion can occur, the quality and the quantity of
`the fusion mass (e.g. bone graft), and the Stability of the
`construct. However, the overall size of interbody spinal
`fusion implants is limited by the shape of the implants
`relative to the natural anatomy of the human spine. For
`example, Such implants cannot dangerously protrude from
`the Spine where they might cause injury to one or more of
`the proximate Vital Structures including the large blood
`vessels.
`With reference to FIG. 4, a top plan view of the endplate
`region of a vertebral body V is shown to illustrate the area
`Havailable to safely receive an implant(s) inserted from the
`anterior aspect (front) of the spine, with the blood vessels
`retracted.
`As can be seen in FIG. 5, a top plan view of the endplate
`region of a vertebral body V with the outlines of two
`differentially sized prior art implants A and B installed, one
`on each side of the midline of the vertebral body V, are
`shown. The implantation of Such prior art implants A and B
`is limited by their configuration and the vascular Structures
`present adjacent anteriorly to the implantation Space. For
`example, the great vessels GV present at the L level and
`above are shown in solid line in FIG. 5, and for the Ls and
`S levels, the iliac artery and vein IA-V are shown in dotted
`line. AS Shown in FIG. 5, prior art implant A represents an
`attempt by the Surgeon to optimize the length of the implant
`which is inhibited by a limiting corner LC. Implant A, the
`
`15
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`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates generally to interbody Spinal
`fusion implants that are Securely placed into the interverte
`bral Space created acroSS the Spinal disc between two
`adjacent vertebral bodies after the removal of damaged
`Spinal disc material and preferably at least Some vertebral
`bone from each of the adjacent vertebral bodies for the
`purpose of achieving interbody Spinal fusion, which fusion
`occurs preferably at least in part through the Spinal fusion
`implant itself. In particular, the present invention is directed
`to an improved, interbody Spinal fusion implant having
`opposed arcuate Surfaces for penetrably engaging each of
`the vertebral bodies adjacent a disc Space in the human Spine
`and having a trailing end configured to conform to the
`anatomic contour of the anterior and/or lateral aspects of the
`vertebral bodies, so as to not protrude beyond the curved
`contours thereof, and in one preferred embodiment of the
`present invention the above described implants are structur
`ally adapted to be rotated for proper insertion.
`2. Description of the Related Art
`Surgical interbody Spinal fusion generally refers to the
`methods for achieving a bridge of bone tissue in continuity
`between adjacent vertebral bodies and acroSS the disc Space
`to thereby substantially eliminate relative motion between
`the adjacent vertebral bodies. The term “disc space” refers to
`the Space between adjacent vertebrae normally occupied by
`a spinal disc.
`Human vertebral bodies have a hard outer shell of com
`pact bone (Sometimes referred to as the cortex) and a
`35
`relatively Softer, inner mass of cancellous bone. Just below
`the cortex adjacent the disc is a region of bone referred to
`herein as the “subchondral Zone'. The outer shell of compact
`bone (the boney endplate) adjacent to the spinal disc and the
`underlying Subchondral Zone are together herein referred to
`as the boney “end plate region' and, for the purposes of this
`application, is hereby So defined to avoid ambiguity. A
`circumferential ring of dense bone extends around the
`perimeter of the endplate region and is the mature boney
`Successor of the "apophySeal growth ring”. This circumfer
`ential ring comprises of very dense bone and for the pur
`poses of this application will be referred to as the "apophy
`seal rim'. The spinal disc that normally resides between the
`adjacent vertebral bodies maintains the Spacing between
`those vertebral bodies and, in a healthy spine, allows for the
`normal relative motion between the vertebral bodies.
`Reference is made throughout this Background Section to
`the attached drawings in order to facilitate an understanding
`of the related art and problems associated therewith. In FIG.
`1, a cross-sectional top plan view of a vertebral body V in
`the lumbar spine is shown to illustrate the dense bone of the
`apophyseal rim AR present at the perimeter of the vertebral
`body V about the endplate region and an inner mass of
`cancellous bone CB. The structure of the vertebral body has
`been compared to a core of wet balsa wood encased in a
`laminate of white oak. From the top plan view in FIG. 1, it
`can be seen that the best Structural bone is peripherally
`disposed.
`FIG. 2 is a top plan view of a fourth level lumbar vertebral
`body V shown in relationship anteriorly with the aorta and
`vena cava (collectively referred to as the "great vessels'
`GV).
`
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`60
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`3
`longest prior art implant that can be inserted without inter
`fering with the great vessels GV adjacent the vertebral body
`V, leaves cross-hatched area X of a croSS Section the verte
`bral body at the endplate region wasted which would be a
`very useful Surface for contact for fusion and for Support of
`the implant by the vertebral body. Similarly, implant B is an
`attempt by the Surgeon to optimize the width of an implant
`which is also inhibited by a limiting corner LC". Implant B,
`the widest prior art implant that can be inserted without
`interfering with the great vessels GV adjacent the vertebral
`body V, leaves cross-hatched area Y of the cross section of
`the vertebral body adjacent the endplate region wasted
`which could otherwise be a very useful surface area for
`contact for fusion and for Support of the implant by the
`vertebral body. The presence of limiting corners LC and LC"
`on any Such implants precludes the Surgeon from Safely
`utilizing an implant having both the optimal width and
`length, that is the length of implant A and the width of
`implant B combined, as Such an implant would markedly
`protrude from the Spine and endanger the large blood
`vessels.
`FIG. 5 illustrates the maximum dimensions for the above
`discussed prior art implants A and B to be safely contained
`within the spine so that a corner LC or LC" of the trailing end
`(side wall to trailing end junction) or the most rearward
`extension of that Sidewall does not protrude outward beyond
`the rounded contour of the anterior (front) or the anterolat
`eral (front to side) aspect of the vertebral bodies. Prior art
`implant A maximizes length, but Sacrifices width and for the
`most part fails to Sit over the best Supportive bone periph
`erally of the apophyseal rim as previously shown in FIG. 1.
`Prior implant B maximizes width, but sacrifices length and
`again fails to sit over the best structural bone located
`peripherally in the apophyseal rim of the vertebral body,
`comprising of the cortex and dense Subchondral bone. Both
`prior art implants A and B fail to fill the area available with
`a loss of both vital Surface area over which fusion could
`occur and a loSS of the area available to bear the considerable
`loads present acroSS the Spine.
`Similarly, FIG. 6A shows the best prior art cross-sectional
`area fill for a pair of inserted threaded implants G as per the
`current prior art. Note the area Y anterior to the implants G,
`including the excellent Structural bone of the apophyseal rim
`AR, is left unused, and thus implants G fail to find the best
`vertebral Support. Since the wasted area Y anterior to the
`implants G is three dimensional, it also wastes a Volume that
`optimally could be utilized to hold a greater quantity of
`Osteogenic material. Finally, the implants of the prior art fail
`to achieve the optimal stability that could be obtained by
`utilizing the greater available Surface area of contact and
`improved length that an implant with the maximum width
`and length would have, and thereby the best lever arms to
`resist rocking and tilting, and increased contact area to carry
`further Surface protrusions for providing Stability by engag
`ing the vertebrae, Such as with the example shown of a
`helical thread.
`FIG. 11 shows the best fill obtained when a prior art
`implant C is inserted, from a lateral approach to the Spine
`(from a position anterior to the transverse processes of the
`vertebrae) referred to herein as the “translateral approach” or
`“translaterally across the transverse width W of vertebral
`body V. Some examples of implants inserted from the
`translateral approach are the implants disclosed in U.S. Pat.
`No. 5,860,973 to Michelson and preferably inserted with the
`method disclosed in U.S. Pat. No. 5,772,661 to Michelson.
`Implant C does not entirely occupy the croSS-Sectional area
`of the end plate region and leaves cross-hatched area Z of the
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`4
`vertebral body V unoccupied by the implant which area
`would be useful for contact for fusion and for support of the
`implant. The configuration of the trailing corner LC" of the
`prior art implant C prevents implant C from being sized
`larger and prevents the full utilization of the Surface area of
`contact of the vertebral body croSS-Sectional area resulting in
`a Sub-optimal fill of the disc Space with the implant, and little
`of the implant Sitting on the apophyseal rim.
`The configuration of prior art implants prevents the ulti
`lization of the apophyseal rim bone, located at the perimeter
`of the vertebral body to Support the implants at their trailing
`ends. The utilization of this dense bone would be ideal.
`Therefore, there is a need for an interbody Spinal fusion
`implant having opposed arcuate portions for penetrably
`engaging adjacent vertebral bodies, including implants
`requiring rotation for proper insertion into an intervertebral
`Space formed acroSS the disc Space between two adjacent
`vertebrae, that is capable of fitting within the external
`perimeter of the vertebral bodies between which the implant
`is to be inserted to maximize the Surface area of contact of
`the implant and vertebral bone without the danger of inter
`fering with the great vessels adjacent to the vertebrae into
`which the implant is to be implanted. There exists a further
`need for an implant that is adapted to utilize the dense
`cortical bone in the perimeter of the vertebral bodies in
`Supporting Such an implant installed in a disc Space.
`SUMMARY OF THE INVENTION
`The present invention relates to preformed, manufactured
`interbody Spinal fusion implants for placement between
`adjacent vertebral bodies of a human spine at least in part
`acroSS the disc Space between those adjacent vertebral
`bodies, without dangerously extending beyond the outer
`dimensions of the two adjacent vertebral bodies adjacent
`that disc Space, to maximize the area of contact of the
`implant with the vertebral bone. For example, the present
`invention specifically excludes bone grafts harvested from a
`patient and shaped by a Surgeon at the time of Surgery Such
`as those of cancellous or corticocancellous bone. The
`present invention can benefit implants requiring an element
`of rotation for proper insertion into the implantation Space,
`and more generally, any and all interbody Spinal fusion
`implants having opposed arcuate Surfaces Spaced apart to
`penetrably engage within the Substance of the opposed
`adjacent vertebral bodies, as opposed to merely contacting
`those vertebral bodies at their exposed boney end plates.
`In one embodiment of the present invention, an implant
`for insertion from the anterior approach of the Spine and for
`achieving better filling of the anterior to posterior depth of
`the disc Space between two adjacent vertebral bodies com
`prises opposed arcuate portions for penetrably engaging the
`bone of the adjacent vertebral bodies deep into the boney
`endplate, a leading end which is inserted first into the disc
`Space, and an opposite trailing end. The trailing end of this
`embodiment of the implant of the present invention is
`generally configured to conform to the natural anatomical
`curvature of the perimeter of the anterior aspect of vertebral
`bodies, such that when the implant is fully inserted and
`properly Seated within and across the disc space, the Surface
`area of the vertebral bone in contact with the implant is
`maximized Safely. Moreover, the implant of the present
`invention is able to Seat upon the dense compacted bone in
`the perimeter of the vertebral bodies for supporting the load
`through the implant when installed in the intervertebral
`Space.
`More Specifically, in the present invention, while the
`implant overall may be enlarged relative to the sizes possible
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`IPR2019-00362, Ex. 1053, p. 13 of 23
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`with prior implants, the limiting corner of the trailing end
`and Side wall at the trailing end has been removed. It has
`been the need in the past to keep this limiting corner of the
`implant from protruding beyond the perimeter of the disc
`Space that has prevented these same implants from being of
`the optimal size overall So as to maximize the area of contact
`and to Seat upon and be Supported by the peripheral rim of
`densely compacted bone.
`AS another example, for an implant to be inserted from the
`lateral aspect of the Spine, the implant of the present
`invention has opposed arcuate Surfaces for penetrably
`engaging each of the vertebral bodies adjacent the disc Space
`to be fused, a leading end which is inserted first into the disc
`Space, and an opposite trailing end. The trailing end is
`configured to conform to the curvature of the lateral aspect
`of the perimeter of the vertebral bodies adjacent the disc
`Space and without dangerously extending beyond the outer
`dimensions of the two vertebral bodies, such that when the
`implant is inserted in the disc Space, the Surface area of the
`vertebral bone in contact with the implant is maximized
`without interfering with any of the Vital Structures adjacent
`to those vertebral bodies.
`The Spinal implants of the present invention may also
`have at least one opening allowing for communication
`between the opposed upper and lower vertebrae engaging
`Surfaces to permit for bone growth in continuity through the
`implant from the adjacent vertebral bodies for fusion acroSS
`the disc Space of the adjacent vertebral bodies, and through
`the implant.
`For any of the embodiments of the present invention
`described herein, the implants may include protrusions or
`Surface roughenings for engaging the bone of the vertebral
`bodies adjacent to the implant. The material of the implant
`may be an artificial material Such as titanium or one of its
`implant quality alloys, cobalt chrome, tantalum, or any other
`metal appropriate for Surgical implantation and use as an
`interbody Spinal fusion implant, or ceramic, or composite
`including various plastics, carbon fiber composites, and can
`include materials which are at least in part bioresorbable.
`The materials of the implant also can include transplants of
`cortical bone or other naturally occurring materials Such as
`coral, and the implants may further comprise osteogenic
`materials. Such as bone morphogenetic proteins, or other
`chemical compounds, the purpose of which is to induce or
`otherwise encourage the formation of bone, or fusion,
`including genetic material coding for production of bone.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a top plan view of a horizontal cross-section
`through a boney endplate region of a vertebral body.
`FIGS. 2-3 are top plan views of the fourth and fifth level
`lumbar vertebral bodies in relationship to the blood vessels
`located anteriorly thereto.
`FIG. 4 is a top plan plan view of an endplate region of a
`vertebral body illustrating the area available to safely
`receive an implant(s) inserted from the anterior aspect of the
`Spine and the area of the annulus that typically remains from
`an implantation from an anterior approach.
`FIG. 5 is a top plan view of a lumbar vertebral body
`depicting the Safe area of insertion for variously propor
`tioned prior art implants for placement to either side of the
`midline.
`FIG. 6A is a top plan view of the endplate region of a
`vertebral body depicting the best fit for two threaded spinal
`implants of the prior art implanted on either side of the
`midline.
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`US 6,241,770 B1
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`FIG. 6B is a top plan view of the endplate region of the
`vertebral body shown in FIG. 6A illustrating the optimal
`proportions and shape of an embodiment of an implant in
`accordance with the present invention.
`FIG. 6C is a top plan view of the endplate region of the
`vertebral body shown in FIG. 6A and two threaded spinal
`fusion implants of the present invention depicting the opti
`mal proportions and shape for Such interbody fusion
`implants.
`FIG. 7A a top plan view of threaded spinal fusion implant
`of the present invention with a driver instrument for engag
`ing the trailing end of the implant.
`FIG. 7B is cross-sectional view along lines 7B-7B of
`FIG 7A.
`FIG. 7C is cross-sectional view of an alternative embodi
`ment.
`FIG. 8 is a front elevational view of two adjacent vertebral
`bodies with the outline of another embodiment of the
`implant of the present invention inserted centrally from an
`anterior approach to the Spine.
`FIG. 9 is a top plan view of the endplate region of a
`vertebral body and implant along line 9-9 of FIG. 8.
`FIG. 10 is a top plan view of the endplate region of a
`vertebral body with the outlines of two implants in accor
`dance with another embodiment of the present invention
`implanted to either side of the midline.
`FIG. 11 is a top plan view of the endplate region of a
`vertebral body with a prior art implant implanted translat
`erally across the transverse width of the vertebral body from
`a lateral aspect of the Spine.
`FIG. 12A is a top plan view of the endplate region of the
`vertebral body of FIG. 11 with an implant of the present
`invention implanted translaterally acroSS the transverse
`width of the vertebral body from a lateral aspect of the spine.
`FIG. 12B is a top plan view of the endplate region of the
`vertebral body of FIG. 11 with an alternative embodiment of
`implants of the present invention implanted translaterally
`across the transverse width of the vertebral body from a
`lateral aspect of the Spine, with the gap between the implants
`exaggerated for visual effect.
`FIG. 12C is a trailing end view of a first of the implants
`shown in FIG. 12B.
`FIG. 12D is a leading end view of a second of the implants
`shown in FIG. 12B.
`FIG. 13A is a side elevational view of two adjacent
`vertebral bodies with two implants of another embodiment
`of the present invention implanted translaterally Side-by
`side across the transverse width of the vertebrae from a
`lateral aspect of the Spine.
`FIG. 1 3B is a top plan view of the endplate region of a
`vertebral body along lines 13B-13B of FIG. 13A.
`FIG. 14A is a side elevational view of two adjacent
`vertebral bodies with two implants of another embodiment
`of the present invention implanted translaterally across the
`transverse width of the vertebral from a lateral aspect of the
`Spine.
`FIG. 14B is a top plan view of the endplate region of a
`vertebral body along line 14B-4B of FIG. 14A.
`FIGS. 15A and 15B are top plan views of alternative
`embodiments of the implant of the present invention illus
`trated in outline form.
`FIG. 16A is a top view of an alternative embodiment of
`the implant of the present invention illustrated in outline
`form.
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`IPR2019-00362, Ex. 1053, p. 14 of 23
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`FIG. 16B is a side elevational view of the implants of
`FIGS. 15A, 15B, and 16A from long side “L”.
`DETAILED DESCRIPTION OF THE
`INVENTION
`FIG. 6B shows in outline form the optimal area available
`to be occupied by one fusion implant 100 to be inserted into
`the intervertebral Space in Side by Side pairs.
`With reference to FIGS. 6C, 7A, and 7B, a first embodi
`ment of the present invention comprising an interbody Spinal
`implant generally referred by the numeral 100, is shown
`inserted from the anterior aspect of a vertebral body V to
`each side of the midline M in the lumbar spine. In one
`embodiment of the present invention, implant 100 has a
`leading end 102 for insertion into the disc Space, an opposite
`trailing end 104 configured to generally conform to at least
`a portion of the natural anatomical curvature of the anterior
`aspect of the vertebral bodies adjacent the disc Space, and
`more narrowly to be foreshortened at that aspect of the
`implant trailing end, that would be most lateral within the
`disc space when implanted within the spine. Implant 100 has
`opposed arcuate portions 106 and 108 that are oriented
`toward and adapted to penetrably engage within the adjacent
`vertebral bodies when inserted across the intervertebral
`space. Opposed arcuate portions 106 and 108 have a dis
`tance therebetween defining an implant height greater than
`the height of the disc Space at implantation. Preferably, each
`of the opposed arcuate portions 106 and 108 have at least
`one opening 110 in communication with one another to
`permit for the growth of bone in continuity from the adjacent
`vertebral bodies and through implant 100, and as herein
`shown implant 100 may further be hollow or at least in part
`hollow. Implant 100 may also include surface roughening
`Such as thread 120 for penetrably engaging the boned of the
`adjacent vertebral bodies.
`As a result of its configuration, when implant 100 is
`inserted between two adjacent vertebral bodies, implant 100
`is contai