Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 1 of 180 PageID #: 1886
`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 1 of 180 PagelD #: 1886
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`EXHIBIT 1
`EXHIBIT 1
`
`
`
`
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 2 of 180 PageID #: 1887
`I 1111111111111111 1111111111 11111 111111111111111 IIIII IIIII 111111111111111111
`USO 11065128B2
`
`c12) United States Patent
`Zappacosta et al.
`
`(IO) Patent No.: US 11,065,128 B2
`(45) Date of Patent:
`Jul. 20, 2021
`
`(54)
`
`INTERVERTEBRAL IMPLANTS AND
`RELATED METHODS OF USE
`
`(71) Applicant: GLOBUS MEDICAL, INC., Audubon,
`PA (US)
`
`(72)
`
`Inventors: Jason Zappacosta, Philadelphia, PA
`(US); Mark Fromhold, Phoenixville,
`PA (US); Jason Gray, East Greenville,
`PA (US); Michael Hunt, Austin, TX
`(US); Chris Saville, Morgantown, PA
`(US); Robert Rhoads, North Wales, PA
`(US); Michael Evangelist, Pottstown,
`PA (US); John Perkins, Pottstown, PA
`(US); Nick Padovani, Wynnewood, PA
`(US)
`
`(73)
`
`Assignee: Globus Medical, Inc., Audubon, PA
`(US)
`
`( *)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by O days.
`
`(21) Appl. No.: 15/962,174
`
`(22) Filed:
`
`Apr. 25, 2018
`
`(65)
`
`Prior Publication Data
`
`US 2018/0250142 Al
`
`Sep. 6, 2018
`
`Related U.S. Application Data
`
`(63)
`
`Continuation of application No. 14/476,439, filed on
`Sep. 3, 2014, now Pat. No. 9,980,824.
`
`(51)
`
`(52)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61F 2144
`A61F 2146
`A61F 2/30
`U.S. Cl.
`CPC .......... A61F 214455 (2013.01); A61F 214465
`(2013.01); A61F 214611 (2013.01); A61F
`2002/305 (2013.01); A61F 2002/3008
`
`(2013.01); A61F 2002/30179 (2013.01); A61F
`2002/30308 (2013.01); A61F 2002/30433
`(2013.01); A61F 2002/30593 (2013.01); A61F
`2002/30604 (2013.01); A61F 2002/30677
`(2013.01); A61F 2002/30787 (2013.01); A61F
`2002/30797 (2013.01);
`
`(Continued)
`(58) Field of Classification Search
`CPC ........ A61F 2/442; A61F 2/4455; A61F 2/446;
`A61F 2/4465; A61F 2/447; A61F
`2002/4475; A61F 2002/30179; A61F
`2002/30308
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2011/0230971 Al*
`
`2013/0150968 Al *
`
`9/2011 Donner ................. A61F 2/4455
`623/17.16
`A61B 17 /84
`623/17.16
`
`6/2013 Dinville .
`
`* cited by examiner
`
`Primary Examiner - Eduardo C Robert
`Assistant Examiner - Christina Negrelli-Rodriguez
`
`ABSTRACT
`(57)
`A method of implanting an intervertebral spacer may include
`positioning the intervertebral spacer within an intervertebral
`space defined by adjacent vertebral bodies. The interverte(cid:173)
`bral spacer may include a plurality of bores, and each of the
`plurality of bores may be configured to receive either a linear
`fastening element or a curvilinear fastening element. The
`method also may include selecting a first fastening element
`from a group including linear fastening elements and cur(cid:173)
`vilinear fastening elements, and inserting the first fastening
`element into a first bore of the plurality of bores such that the
`first fastening element is inserted into one of the adjacent
`vertebral bodies to secure the intervertebral spacer within
`the intervertebral space.
`
`20 Claims, 17 Drawing Sheets
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 3 of 180 PageID #: 1888
`
`US 11,065,128 B2
`Page 2
`
`(52) U.S. Cl.
`CPC ............... A61F 2002/30836 (2013.01); A61F
`2002/30841 (2013.01); A61F 2002/30845
`(2013.01); A61F 2002/30884 (2013.01); A61F
`2002/4627 (2013.01)
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 4 of 180 PageID #: 1889
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 1 of 17
`
`US 11,065,128 B2
`
`m
`00
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`~
`
`N
`.........
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 5 of 180 PageID #: 1890
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 2 of 17
`
`US 11,065,128 B2
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 6 of 180 PageID #: 1891
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 3 of 17
`
`US 11,065,128 B2
`
`(0
`N
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 7 of 180 PageID #: 1892
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 4 of 17
`
`US 11,065,128 B2
`
`lsf)
`
`c:;
`Li:
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 8 of 180 PageID #: 1893
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 5 of 17
`
`US 11,065,128 B2
`
`(0
`N
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 9 of 180 PageID #: 1894
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 6 of 17
`
`US 11,065,128 B2
`
`N
`0)
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 10 of 180 PageID #: 1895
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 7 of 17
`
`US 11,065,128 B2
`
`___ .,,....
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`0 .,,....
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`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 11 of 180 PageID #: 1896
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 8 of 17
`
`US 11,065,128 B2
`
`116
`~ '
`'
`
`113
`
`113
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`148 118
`
`124
`
`148 FIG. 11
`
`128
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`120
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`117
`
`FIG. 12
`
`FIG. 13
`
`128
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`11a
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`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 12 of 180 PageID #: 1897
`
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`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 13 of 180 PageID #: 1898
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 10 of 17
`
`US 11,065,128 B2
`
`FIG. 20
`
`FIG. 21
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`302
`318
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`300
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`FIG. 22
`
`FIG. 23
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 14 of 180 PageID #: 1899
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 11 of 17
`
`US 11,065,128 B2
`
`208
`
`202
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`206
`
`210
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`216
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`224
`
`FIG. 24
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 15 of 180 PageID #: 1900
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 12 of 17
`
`US 11,065,128 B2
`
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`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 16 of 180 PageID #: 1901
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 13 of 17
`
`US 11,065,128 B2
`
`228
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`\
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`FIG. 26
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`400
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`228
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`FIG. 27
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`234~'-,.
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`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 17 of 180 PageID #: 1902
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 14 of 17
`
`US 11,065,128 B2
`
`A
`
`328
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`~
`304
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`FIG. 29
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`FIG. 30
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`FIG. 32
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`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 18 of 180 PageID #: 1903
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 15 of 17
`
`US 11,065,128 B2
`
`314
`
`316
`
`310
`
`FIG~ 33
`
`322
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`FIG. 34
`
`326
`
`326
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`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 19 of 180 PageID #: 1904
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 16 of 17
`
`US 11,065,128 B2
`
`323
`
`320
`FIG. 35
`
`308
`
`310
`
`316
`
`316
`
`312
`
`320
`
`316 FIG. 36
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 20 of 180 PageID #: 1905
`
`U.S. Patent
`
`Jul. 20, 2021
`
`Sheet 17 of 17
`
`US 11,065,128 B2
`
`400
`~
`
`423
`
`410
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`426
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`431
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`426
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`FIG. 39
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 21 of 180 PageID #: 1906
`
`US 11,065,128 B2
`
`1
`INTERVERTEBRALIMPLANTSAND
`RELATED METHODS OF USE
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`The present application is a continuation of U.S. patent
`application Ser. No. 14/476,439, filed Sep. 3, 2014, which is
`herein incorporated by reference in its entirety
`
`FIELD OF THE INVENTION
`
`Various examples of the present disclosure relate gener(cid:173)
`ally to vertebral implants and related systems and methods.
`More specifically, the present disclosure relates to vertebral
`anchors, spacers, devices, systems, and methods for repair(cid:173)
`ing and/or replacing intervertebral discs of a patient.
`
`BACKGROUND
`
`5
`
`20
`
`2
`FIGS. 1-8 illustrate various views of a vertebral spacer in
`accordance with a first exemplary embodiment of the pres(cid:173)
`ent disclosure.
`FIG. 9 is a perspective view of another exemplary
`intervertebral spacer in accordance with an example of the
`present disclosure.
`FIG. 10 is an insertion device in accordance with an
`example of the present disclosure.
`FIGS. 11-14 depict various end or cross-sectional views
`10 of the insertion device of FIG. 10.
`FIGS. 15-17 depict the insertion device of FIG. 10
`coupled with an intervertebral anchor in accordance with an
`example of the present disclosure.
`FIGS. 18-23 depict an exemplary tool and method of
`15 installing a vertebral anchor in accordance with an example
`of the present disclosure.
`FIG. 24 is a perspective view of another exemplary
`insertion device in accordance with an example of the
`present disclosure.
`FIG. 25 is a perspective view of an insertion device and
`an intervertebral spacer having a plurality of fasteners in
`accordance with an example of the present disclosure.
`FIGS. 26-28 depict another exemplary method of install(cid:173)
`ing a vertebral anchor in accordance with an example of the
`25 present disclosure.
`FIG. 29 is a side view of a vertebral anchor in accordance
`with an example of the present disclosure.
`FIG. 30 is an enlarged view of detail A in FIG. 29,
`illustrating a distal portion of the vertebral anchor of FIG.
`30 29.
`FIG. 31 is a top view of the vertebral anchor of FIG. 29.
`FIG. 32 is an enlarged view of detail B in FIG. 31,
`illustrating a distal portion of the vertebral anchor of FIG.
`31.
`FIG. 33 is a perspective view of the vertebral anchor of
`FIG. 29.
`FIG. 34 is an enlarged view of detail C in FIG. 33,
`illustrating a distal portion of the vertebral anchor of FIG.
`33.
`FIG. 35 is another perspective view of the vertebral
`anchor of FIG. 29.
`FIG. 36 is an end view of the vertebral anchor of FIG. 29.
`FIGS. 37-40 illustrate various views of another exemplary
`vertebral anchor in accordance with an example of the
`45 present disclosure.
`
`DETAILED DESCRIPTION
`
`A common procedure for handling pain associated with
`intervertebral discs that have become degenerated due to
`various factors such as trauma or aging is the use of
`intervertebral spacers to, e.g., fuse one or more adjacent
`vertebral bodies. Generally, to fuse adjacent vertebral bod(cid:173)
`ies, the native intervertebral disc is first partially or fully
`removed. An intervertebral spacer is then typically inserted
`between neighboring vertebral bodies to maintain normal
`disc spacing and restore spinal stability, thereby facilitating
`an intervertebral fusion.
`There are a number of known conventional intervertebral
`spacers and methodologies in the art for accomplishing the
`vertebral fusion. These include screw and rod arrangements,
`solid bone implants, and intervertebral spacers which
`include a cage or other implant mechanism that may be 35
`packed with bone and/or bone growth inducing substances.
`These devices may be implanted between adjacent vertebral
`bodies in order to fuse the vertebral bodies together, poten(cid:173)
`tially alleviating any associated pain.
`However, there are drawbacks associated with the known 40
`conventional vertebral spacers and methodologies. Some
`conventional vertebral spacers may not be optimally con(cid:173)
`figured for insertion into irregular or curved portions of the
`spine. For example, at the most caudal or most cephalad
`cervical disc spaces or caudal lumbar levels, conventional,
`angled instruments used to install conventional fasteners
`may interfere with the chin, chest, or other portion of a
`patient's anatomy, making insertion of conventional fasten(cid:173)
`ing members difficult.
`
`SUMMARY OF THE DISCLOSURE
`
`The present disclosure relates to examples of interverte(cid:173)
`bral spacers and related methods of use. A method of
`implanting an intervertebral spacer may include positioning 55
`the intervertebral spacer within an intervertebral space
`defined by adjacent vertebral bodies. The intervertebral
`spacer may include a plurality of bores, and each of the
`plurality of bores may be configured to receive either a linear
`fastening element or a curvilinear fastening element.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`The accompanying drawings, which are incorporated in
`and constitute a part of this specification, illustrate various
`exemplary embodiments and together with the description,
`serve to explain the principles of the disclosed examples.
`
`Reference will now be made in detail to embodiments of
`50 the present disclosure, 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. 1-8 illustrate the different views of an intervertebral
`spacer 10 according to the present disclosure. The interver(cid:173)
`tebral spacer 10 as shown in FIGS. 1-8 may be, e.g., a
`stand-alone anterior lumbar interbody spacer used to provide
`structural stability in skeletally mature individuals following
`discectomies. These intervertebral spacers may be available
`60 in various heights and geometric configurations to fit the
`anatomically needs of a wide variety of patients. Specifi(cid:173)
`cally, FIGS. 1-8 illustrate one embodiment of an interver(cid:173)
`tebral spacer 10. Intervertebral spacer 10 may be generally
`positioned in the intervertebral space between two adjacent
`65 vertebral bodies. As shown in the figures, intervertebral
`spacer 10 may include a spacer portion 12 and a plate
`portion 14. In one example, the spacer portion 12 may
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 22 of 180 PageID #: 1907
`
`US 11,065,128 B2
`
`3
`include a graft window 11 for the placement of, e.g., bone
`graft or bone-growth inducing material, to enhance fusion
`between two adjacent vertebral bodies.
`The spacer portion 12 can be comprised of any material
`that is conducive to the enhancement of fusion between the
`two adjacent vertebral bodies. In one particular embodiment,
`the spacer portion 12 is made of PEEK material, which may
`be physiologically compatible. It should be noted that any
`other materials that are physiologically compatible also may
`be used. The spacer portion 12 may include tantalum pins
`that enable radiographic visualization, or other suitable
`radiographic markers. The spacer portion 12 further may
`include superior and inferior surfaces that are provided with
`a plurality of geometric configurations, such as, e.g., pro(cid:173)
`trusions 13 ( e.g., ribs, bumps, other textures, or the like). The
`superior and inferior surfaces of the spacer portion 12 may
`be bi-convex for greater contact with the vertebral endplates
`of the adjacent vertebral bodies. The protrusions 13 can be
`configured to be any size or shape for further anchoring the
`spacer portion 12 to each of the adjacent vertebral bodies.
`Protrusions 13 on the superior and inferior surfaces of each
`implant may grip the endplates of the adjacent vertebral
`bodies to aid in expulsion resistance.
`The plate portion 14 can also be comprised of any
`physiologically compatible material. In one example, the
`plate portion 14 of the intervertebral spacer 10 may be
`formed from titanium. The plate portion 14 may include at
`least one bore 26. In some embodiments, plate portion 14
`may include a plurality of bores 26, in such embodiments,
`one or more bores 26 may or may not include threads for
`receiving corresponding threads on a fastener. That is to say,
`in some examples, one or more of bores 26 may interact with
`features ( e.g., threads) configured to receive features ( e.g.,
`corresponding threads) of a fastening member ( e.g., a linear
`bone screw) to be disposed therethrough. Bores 26 may be
`substantially linear. Such a configuration allows bores 26 to
`receive both linear fastening members and curvilinear fas(cid:173)
`tening members. That is, a given bore 26 may be configured
`to receive either a linear fastening member (e.g., a screw) or
`a curvilinear fastening member (as discussed below in
`greater detail) at the discretion of an operator, surgeon,
`physician, or the like. In one embodiment, e.g., bores 26 may
`include one or more features, e.g., threads, that are config(cid:173)
`ured to engage with threads of a fastening member ( e.g., a
`linear fastening member or bone screw). Further, in some
`examples, a curvilinear fastening member disposed through
`a given bore 26 may be configured so as not to engage the
`threads of the given bore 26. Still further, each bore 26 may
`include locking features configured to engage with compli(cid:173)
`mentary features on a curvilinear fastening member to
`prevent the curvilinear fastening member from rotating
`when disposed through the bore 26. In one example, each
`bore 26 may be defined by a circumferential wall having a
`recess (not shown) disposed therein. The recess may be
`configured to receive a protrusion extending from the cur(cid:173)
`vilinear fastening member to prevent the curvilinear fasten(cid:173)
`ing member from rotating. In one example, three bores 26
`may be provided. In yet another example, two outer bores 26
`may surround a central bore 26. The two outer bores 26 may
`be angled to guide a fastening member ( e.g., a vertebral
`anchor 300 described with reference to FIGS. 29-36, or a
`bone screw) along a first trajectory 40 shown in FIG. 14
`( e.g., toward one of a superior or inferior surface of interver(cid:173)
`tebral spacer 10), while the central bore 26 may be angled
`to guide a fastening member along a second trajectory 42
`(e.g., toward the other of the superior and inferior surface of
`intervertebral spacer 10), and vice versa. In some examples,
`
`4
`all bores 26 may guide respective fasteners along the same
`trajectory. The bores 26 can accommodate a straight longi(cid:173)
`tudinal fastening member (e.g., a screw, pin, or the like)
`and/or a fastening member exhibiting a curvature (e.g.,
`5 vertebral anchor 300 shown in FIGS. 1-8). In some
`examples, a combination of vertebral anchors 300 and
`conventional screws may be used to install the same
`intervertebral spacer 10.
`Also, in the plate portion 14 of the intervertebral spacer
`10 10, a fastener back out prevention mechanism may be
`provided. The fastener back out prevention mechanism may
`include one or more screws 16, each having a head portion
`24 and a shank 22 having threads 22a. Shank 22 may be
`received by a bore 48 (shown in FIG. 8) that extends from
`15 a first side 44 of plate portion 14 toward a second side 46 of
`plate portion 14. Shank 22 also may be received by a nut 18
`having a threaded bore 18a (shown in FIG. 1). Nut 18 may
`have a substantially rectangular cross-section, or may have
`another suitable shape. Nut 18 may be secured within a
`20 recess 20 on second side 46 of plate portion 14. However, it
`is contemplated that screws 16 may be secured to plate
`portion 14 by any other suitable mechanism. Head portion
`24 may have a generally rectangular cross-section such that
`it may prevent a fastening member from backing out of
`25 bores 26 when disposed in certain configurations (e.g., a
`blocking configuration). For example, referring to FIG. 8,
`the head portion 24 of screw 16 may extend over, cover,
`and/or block at least a portion of the opening of one more of
`bores 26, preventing a fastening member ( e.g., a vertebral
`30 anchor 300 or a bone screw) extended through a bore 26
`from backing out of plate portion 14 and a vertebral body.
`It is also contemplated that in some examples, a single head
`portion 24 may extend at least partially over two adjacent
`bores 26 ( e.g., both an outer bore 26 and a central bore 26),
`35 thereby blocking the openings of more than one bore 26 at
`the same time while disposed in a blocking configuration.
`Head portion 24 can be moved from the blocking configu(cid:173)
`ration to a non-blocking configuration by rotating head
`portion by, e.g., 90 degrees or another suitable measure.
`40 While depicted as rectangular, it is contemplated that head
`portion 24 may be formed in other suitable elongate shapes,
`such as, e.g., cylindrical or the like. In the example of FIG.
`8, plate portion 14 may be configured to receive two screws
`16 in bores 48 (shown in FIG. 8). Each of the screws 16 may
`45 be configured to block fastening members disposed in an
`outer bore 26 and a central bore 26, such that each outer bore
`26 is blocked by a single screw 16, and the central bore 26
`is blocked by both screws 16.
`A coupling mechanism may connect the spacer portion 12
`50 and the plate portion 14 rigidly to each other, if desired. With
`reference to FIG. 2, the coupling mechanism may include
`one or more fastening members 34 that extend through
`corresponding recesses 36 disposed through spacer portion
`12 and recesses 38 disposed through at least a portion of
`55 plate portion 14. In one example, a fastening member 26
`may extend through the superior and inferior surfaces of
`spacer portion 12 (via a recess 36) and may be received by
`recess 38 of plate portion 14, thereby coupling spacer
`portion 12 and plate portion 14. It is contemplated that
`60 recess 38 and fastening member 26 may include compli(cid:173)
`mentary mating features (e.g., threads) to facilitate coupling
`of plate portion 14 to spacer portion 12. In the example
`shown in FIG. 2, plate portion 14 may be formed by three
`bore sections 28, 30, and 32. Bore sections 28, 30, and 32
`65 may either be integrally formed or detachable with spacer
`portion 12. In one example, bore section 28 may be integral
`with spacer portion 12 while bore sections 30 and 32 may be
`
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`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 23 of 180 PageID #: 1908
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`US 11,065,128 B2
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`5
`detachable with spacer portion 12 via fastening members 34
`and recesses 36 and 38. In one example, the detachable bore
`sections 30 and 32 may include the outer bores 26 that are
`configured to direct a vertebral anchor 300 or bone screw
`along the first exit trajectory 40, and the bore section 28 may
`include the central bore 26 configured to direct a vertebral
`anchor 300 or bone screw along the second exit trajectory
`42. Further, one or more of the bore sections 28, 30, and 32
`may include a portion configured to extend through a slot of
`or other opening in spacer portion 12. In such examples, the 10
`recesses 36, 38, or the like associated with the bore sections
`may align with recesses formed through spacer portion 12 to
`receive fastening members 34.
`Plate portion 14 also may include coupling features for
`coupling plate portion 14 to an anchor insertion device 100 15
`which will be described further with reference to FIGS.
`10-23. As shown in FIG. 8, plate portion 14 may include a
`channel (e.g., a snap-fit channel) 50 having an opening
`disposed in an outer surface of plate portion 14. The channel
`50 may be configured to receive an extension (e.g., a 20
`cantilever and/or snap-fitting extension) of anchor insertion
`device 100 to couple plate portion 14 to the insertion device
`100. In some examples, channel 50 may be disposed in bore
`section 30 of plate portion 14. With continuing reference to
`FIG. 8, channel 50 may have a generally ovular opening,
`although other suitable opening configurations such as, e.g.,
`circular, square, rectangular, star-shaped, or the like are also
`contemplated. Plate portion 14 also may include a bore 52
`(e.g., a threaded bore) having an opening that is also
`disposed through an outer surface of plate portion 14. In one
`example, bore 52 may be disposed through bore section 32
`of plate portion 14.
`In an exemplary method, a physician, surgeon, or other
`suitable operator may remove, among other things, the
`native intervertebral disc between two vertebral bodies. The
`operator then may select a given intervertebral spacer, e.g.,
`intervertebral spacer 10, to replace the removed native
`intervertebral disc. Based on the geometry of the surround(cid:173)
`ing vertebral bodies and/or anatomy, the operator may
`determine that linear fastening members (e.g., linear bone
`screws), curvilinear fastening members ( e.g., vertebral
`anchors 300 or 400), or a combination of linear fastening
`members and curvilinear fastening members, will provide
`optimal fit and securement of intervertebral spacer 10
`between the vertebral bodies. For example, the curvature of 45
`the spine at one or more of the vertebral bodies may
`substantially inhibit the use of the tools and driving mem(cid:173)
`bers used to install linear fastening members. In such
`examples, curvilinear fastening members may be selected to
`secure intervertebral spacer 10. The curvilinear fastening 50
`members may be installed through the same linear bore 26
`that may be configured to receive linear fastening members.
`Further, the curvilinear fastening members may be installed
`through the linear bore with a positioning member ( de(cid:173)
`scribed with reference to FIG. 10) utilizing a guide member 55
`that can be extended only along a linear track.
`In one example, one or more curvilinear fasteners may be
`used to secure intervertebral spacer 10 to one vertebral body
`defining an intervertebral space, while one or more linear
`fasteners may be used to secure intervertebral spacer 10 to 60
`the other vertebral body defining the intervertebral space.
`For example, curvilinear fasteners may be extended through
`outer bores 26 while a linear fastener is extended through
`central bore 26. Alternatively, linear fastening members may
`be extended through outer bores 26 while a curvilinear 65
`fastening member is extended through central bore 26. In yet
`another example, both linear and curvilinear fastening mem-
`
`6
`bers may be used to secure the same intervertebral spacer
`into a given vertebral body. That is, a curvilinear fastening
`member may be extended through one outer bore 26, while
`a linear fastening member is extended through the other
`5 outer bore 26.
`FIG. 9 depicts an intervertebral spacer 90 in accordance
`with an example of the present disclosure. In some
`examples, intervertebral spacer 90 may be substantially
`similar to intervertebral spacer 10, or may be another
`suitable intervertebral spacer. In the example shown in FIG.
`9, spacer 90 may be a generally rectangular spacer defining
`a cavity 91. Cavity 91 may be packed with bone graft or
`bone-growth inducing materials. Spacer 90 may include one
`or more of inferior surfaces, superior surfaces, biconvex
`surfaces, among others. In some examples, the surfaces of
`spacer 90 or any other bone contacting surface described in
`the present disclosure may include one or more of teeth,
`ridges, friction increasing elements, keels, or gripping or
`purchasing projections.
`Spacer 90 may include a plate portion 92 that may include
`one or more features described with reference to plate
`portion 14 of intervertebral spacer 10. In one example, one
`or more bores 93 may disposed through plate portion 92.
`Though FIG. 9 depicts two bores 93, those of ordinary skill
`25 in the art will recognize that any suitable number of bores
`may be provided. Bores 93 may include one or more features
`described with reference to bores 26 of intervertebral spacer
`10. The two bores 93 may be angled to guide a fastening
`member (e.g., a vertebral anchor 300 or a bone screw) along
`30 differing trajectories. For example, one bore 93 may be
`angled to urge a fastening member along a first trajectory
`( e.g., toward one of a superior or inferior surface of interver(cid:173)
`tebral spacer 90), while the other bore 93 may be angled to
`urge a fastening member along a second trajectory (e.g.,
`35 toward the other of the superior and inferior surface of
`intervertebral spacer 90). The bores 93 can accommodate a
`straight longitudinal fastening member (e.g., a screw, pin, or
`the like) and/or a fastening member exhibiting a curvature
`(e.g., vertebral anchor 300 or 400). In some examples, a
`40 combination of vertebral anchors 300 or 400 and conven-
`tional screws may be used to install the same intervertebral
`spacer 90 as shown in FIG. 25. A circumferential wall
`defining bores 93 may further include one or more recesses
`94 disposed therein. The one or more recesses 94 may be
`configured to receive one or more protrusions 460 disposed
`on a head portion 406 of a vertebral anchor 400 ( described
`with reference to FIGS. 37-40). Thus, in some examples,
`recesses 94 may be partially-spherical to receive protrusions
`460. However, it is contemplated that recesses 94 may be
`formed in any suitable shape configured to receive protru(cid:173)
`sions 460. Plate portion 92 also may include a bore 95
`having an opening that is disposed through an outer surface
`of plate portion 92. The bore 95 may include one or more
`features, e.g., threads or other features to engage with an
`insertion device 200 described with further detail below.
`Intervertebral spacer 90 also may include one or more
`features configured to prevent fastening members from
`backing out of bores 93, such as, e.g., screws 16 described
`with reference to FIGS. 1-8.
`Intervertebral spacer 90 may be inserted into an interver(cid:173)
`tebral space between two vertebral bodies in a substantially
`similar manner as intervertebral spacers 10. In one example,
`one or more curvilinear fasteners may be used to secure
`intervertebral spacer 90 to one vertebral body defining an
`intervertebral space, while one or more linear fasteners may
`be used to secure intervertebral spacer 90 to the other
`vertebral body defining
`the intervertebral space. For
`
`

`

`Case 1:21-cv-01445-JPM Document 80-1 Filed 11/10/22 Page 24 of 180 PageID #: 1909
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`US 11,065,128 B2
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`7
`example, a curvilinear fastener may be extended through one
`bore 93 while a linear fastener is extended through the other
`bore 93.
`An insertion device 100 is shown in FIG. 10, which may
`be used to position vertebral anchors 300 through a plate 5
`portion of an intervertebral spacer (e.g., plate portion 14 of
`intervertebral spacer 10) and through a vertebral body.
`Insertion device 100 may extend from a trailing end 102
`toward a leading end 104. A trailing housing 106 may be
`disposed at trailing end 102 and may define one or more 10
`elongate chamiels 108. In the embodiment shown, three
`elongate channels 108 are shown, although any other suit(cid:173)
`able number of elongate channels 108 may be disposed
`through trailing housing 106. Each of elongate chamiels 108
`may receive a guide member 110 therethrough. Guide mem- 15
`ber 110 may include a head portion 112 and an elongate
`portion 114 that extends away from the head portion 112. In
`some examples, head portion 112 may include one or more
`flattened and reinforced surfaces configured to receive the
`force of a striking member (e.g., a hannner or the like). 20
`Elongate portion 114 may be extended through one or more
`elongate channels 108 toward leading end 104. The distal or
`leading end of elongate portion 114 may include a stepped
`portion 132 (shown in FIG. 18). Stepped portion 132 may be
`separated from the remainder of elongate portion 114 by a 25
`vertical wall 130. In some examples, stepped portion 132
`may include a smaller cross-sectional dimension ( e.g., thick(cid:173)
`ness or width) as compared to a remainder of elongate
`portion 114.
`A connecting housing 115 may extend from trailing 30
`housing 106 toward an anchor housing 116 disposed at
`leading end 104. In some examples, connecting housing 115
`may be an alignment shaft configured to align elongate
`channels 108 with a corresponding number of anchor chan(cid:173)
`nels 118 (see FIG. 11) disposed in anchor housing 116. In the 35
`embodiment shown in FIG. 10, connecting housing 115 may
`extend from only one of elongate channels 108 to couple
`trailing housing 106 to anchor housing 116. However, those
`of ordinary skill in the art will appreciate that a shaft 116
`may extend from more than one elongate channel 108 40
`toward anchor housing 116. Guide member 110 may extend
`through an elongate chamiel 108, through connecting hous(cid:173)
`ing 115, and into an anchor chamiel 118, where it may come
`into contact with a vertebral anchor 300 just before inserting
`the vertebral anchor 300 through a vertebral body, as 45
`described further with reference to FIGS. 18-23. In some
`examples, connecting housing 115 may merely align certain