Exhibit 2007 Page 1
`
`Globus Medical, Inc. v.
`Bonutti Skeletal Innovations LLC
`Case IPR2015-00417
`Bonutti Skeletal Innovations LLC - Ex. 2007
`
`

`
`U.S. PATENT DOCUMENTS
`Buettner-Janz
`7/1988
`9/1988
`Ray
`Harms
`4/1989
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`Brantigan
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`10/1989
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`11/1989
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`6/1990
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`
`Ramirez Jimenez
`Beer
`Bertagnoli
`Erickson
`Michelson
`Kuslich
`Kuslich
`Michelson
`Michelson
`Tornquist
`Shima
`Matsuzaki
`Errico
`Lahille
`Ray
`Bertagnoli
`Kuslich
`Ulrich
`Schonhoffer
`Chen
`
`4,759,766
`4,772,287
`4,820,305
`4,834,757
`4,863,476
`4,874,389
`4,877,020
`4,878,915
`4,880,343
`4,892,546
`4,927,421
`4,932,975
`4,936,848
`4,950,270
`4,961,740
`5,015,247
`5,015,255
`5,026,373
`5,055,104
`5,059,193
`5,062,845
`5,064,425
`5,071,437
`5,139,499
`5,147,402
`5,171,278
`5,192,237
`5,192,327
`5,195,541
`5,236,460
`5,258,031
`5,263,953
`5,290,312
`5,300,076
`5,306,310
`5,313,962
`5,330,535
`5,336,223
`5,354,302
`5,357,983
`5,360,430
`5,390,683
`5,395,317
`5,413,602
`5,423,816
`5,423,817
`5,425,772
`5,429,447
`5,431,658
`5,439,464
`5,443,514
`5,443,515
`5,445,639
`5,458,638
`5,458,641
`5,458,642
`5,480,442
`5,482,417
`5,484,437
`5,489,307
`5,489,308
`5,505,732
`5,522,899
`5,533,863
`5,534,029
`5,534,031
`5,549,608
`5,554,191
`5,562,736
`5,571,109
`5,571,189
`5,571,190
`5,571,192
`5,575,790
`
`D>>D>D>D>J>D>>D>>D>>D>D>D>>D>D>D>J>D>D>D>D>D>D>D>D>I>J>>D>>D>J>D>J>D>D>D>D>D>i>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>D>i>
`
`Kojimoto
`Leriche
`Siebels
`Obenchain
`Moser
`Rogers
`
`Metz-Smvenhagen
`Lin
`
`US 8,337,559 B2
`Page 2
`
`D>D>>D>>D>>>D>>3>>D>D>D>D>3>
`
`5,591,235
`5,653,763
`5,658,335
`5,658,336
`5,665,122
`5,693,100
`5,702,449
`5,702,453
`5,702,455
`5,720,746
`5,723,013
`5,776,197
`5,776,198
`5,782,432
`5,989,290
`6,015,436
`6,086,613
`6,176,881
`6,177,883
`6,190,413
`6,190,414
`6,193,756
`6,200,348
`6,524,341
`6,730,088
`6,752,832
`6,866,682
`2006/0100710
`2006/0293755
`2007/0191954
`
`1/1997
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`2/1998
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`7/1998
`7/1998
`7/1998
`11/1999
`1/2
`7/2
`1/2
`1/2
`2/2
`2/2
`2/2
`3/2
`2/2
`52
`6/2
`3/2
`5/2
`12/2
`8/2
`
`G\lO\O\U1-lk-l>b.)>—->->->—>—>—OO
`
`Kuslich
`Errico
`Allen
`Pisharodi
`Kambin
`Pisharodi
`Mckay
`Rabbe et al.
`Saggar
`Soubeiran
`Jeanson et al.
`Rabbe et al,
`Rabbe
`Renshaw
`Biedermann et al.
`Schonhoffer
`Camino et al.
`Schar et al.
`Jennetti
`Sutcliffe
`Young
`Studer
`Biedermann
`Lang
`Yeh
`Neurnann
`An et al.
`Gutlin
`Lindner et al.
`Hansell et al.
`
`
`
`UUUUUUUUUUUUUUUUUUL41L41L41L11[41111141141141141141141141141141141141141
`
`ff}“U
`
`FOREIGN PATENT DOCUMENTS
`3023942
`1/1982
`3741487 A1
`6/1989
`4012622
`7/1991
`4012622 C1
`7/1991
`9107494 U
`10/1991
`395524
`1/1993
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`7/1993
`4315757 C1
`11/1994
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`9/1995
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`1/1996
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`3/1990
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`1/1982
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`7/1987
`5-15548
`1/1993
`WO 92/01428
`2/1992
`WO9201428
`2/1992
`WO 94/18913
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`WO9525486
`9/1995
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`6/1996
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`1/1997
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`12/1997
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`4/2000
`WO9846173 A1
`4/2000
`
`Exhibit 2007 Page 2
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`Exhibit 2007 Page 2
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`

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`U.S. Patent
`
`Dec. 25, 2012
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`Sheet 1 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 3
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`

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`U.S. Patent
`
`Dec. 25, 2012
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`Sheet 2 of 25
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`US 8,337,559 B2
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`/Marya
`
`62
`
`611/..
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`Exhibit 2007 Page 4
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`Exhibit 2007 Page 4
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`

`
`U.S. Patent
`
`Dec. 25, 2012
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`Sheet 3 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 5
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`Exhibit 2007 Page 5
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`

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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 4 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 6
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`Exhibit 2007 Page 6
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`

`
`U.S. Patent
`
`Dec. 25, 2012
`
`Sheet 5 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 7
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`Exhibit 2007 Page 7
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`

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`U.S. Patent
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`52f06LI.9ehS
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`US 8,337,559 B2
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`Exhibit 2007 Page 8
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`

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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 7 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 9
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`Exhibit 2007 Page 9
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`

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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 8 of 25
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`US 8,337,559 B2
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`190
`
`FIG. 19
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`Exhibit 2007 Page 10
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`Exhibit 2007 Page 10
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`

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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 9 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 11
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`Exhibit 2007 Page 11
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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 10 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 12
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`Exhibit 2007 Page 12
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`

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`Exhibit 2007 Page 13
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`

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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 12 of 25
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`US 8,337,559 B2
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`Exhibit 2007 Page 14
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`Exhibit 2007 Page 14
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`Exhibit 2007 Page 17
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`U.S. Patent
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`Dec. 25, 2012
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`U.S. Patent
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`U.S. Patent
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`US 8,337,559 B2
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`Exhibit 2007 Page 20
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`U.S. Patent
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`Dec. 25, 2012
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`52f091LI.8C.h__S
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`US 8,337,559 B2
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`Exhibit 2007 Page 21
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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 20 of 25
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`US 8,337,559 B2
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`Dec. 25, 2012
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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 23 of 25
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`US 8,337,559 B2
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`FIG. 43
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`Dec. 25, 2012
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`U.S. Patent
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`Dec. 25, 2012
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`Sheet 25 of 25
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`US 8,337,559 B2
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`500
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`@502
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`FIG. 46
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`Exhibit 2007 Page 27
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`US 8,337,559 B2
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`1
`EXPANDABLE VERTEBRAL PROSTHESIS
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`_
`
`The present application is a Continuation of U.S. applica-
`tion Ser. No. 1 1/464,625 filed onAug. 15,2006 now U.S. Pat
`No. 7,811,327 which was a Continuation-In-Part of co-pend-
`ing U.S. patent application Ser. No. 11/110,844, filedApr. 21,
`2005 now U.S. Pat. No. 7,674,296, the entire contents of
`which are incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`The present invention relates to a device to support the
`spine after removal of at least a part of a vertebra.
`
`BACKGROUND OF THE INVENTION
`
`When a vertebra is damaged or diseased, surgery may be
`used to replace the vertebra or a portion thereof with a pros-
`thetic device to restore spinal column support. For example,
`vertebral body replacement is commonly required in the
`treatment of vertebral fracture, tumor, or infection.
`In recent years, several artificial materials and implants
`have been developed to replace the vertebral body, such as, for
`example, titanium cages, ceramic, ceramic/glass, plastic or
`PEEK, and carbon fiber spacers. Recently, various expand-
`able prosthetics or expandable cages have been developed
`and used for vertebral body replacement. The expandable
`prosthetic devices are generally adjustable to the size of the
`cavity created by a corpectomy procedure and typically are at
`least partially hollow to accommodate bo11e cement or bone
`fragments to facilitate fusion in vivo. Some expandable pros-
`thesis may be adjusted prior to insertion i11to the cavity, while
`others may be adjusted i11 situ. One advantage ofthe vertebral
`body replacement using an expandable prosthetic device that
`is adjustable in situ is that it is easy to place or insert because
`it pennits an optimal, tight fit and correction of the deformity
`by in vivo expansion of the device. Some other advantages
`offered by an expandable prosthetic device are that they can
`facilitate distraction across the resected vertebral defect for
`
`correction of the deformity, and allow immediate load bear-
`ing after corpectomy.
`Instrumentation and specialized tools for insertion of a
`vertebral implant is one important design parameter to con-
`sider when designing a vertebral prosthesis. Spinal surgery
`procedures can present several challenges because of the
`small clearances around the prosthetic when it
`is being
`inserted into position. Another important design consider-
`ation includes the ability of the device to acconnnodate vari-
`ous surgical approaches for insertion ofthe vertebral implant.
`
`SUMMARY OF THE INVENTION
`
`The present invention relates to an expandable prosthetic
`implant device for engagement between vertebrae generally
`comprising an inner member, outer member, and gear mem-
`ber positioned coaxial with respect to each other such that the
`inner and outer members are moveable relative to each other
`
`along an axis. The inner member has a hollow interior portion
`and a threaded external portion and includes a first end por-
`tion configured to engage a first vertebral body. The outer
`member has a hollow interior portion configured to receive
`the inner member and includes a second end portion config-
`ured to engage a second vertebral body. The gear member is
`axially fixed to the outer member and freely rotatable with
`
`2
`
`respect to the outer member and the gear member threadedly
`engages the threaded portion of the inner member.
`The implant is configured to engage the vertebrae such that
`first and second end portions are oriented i11 a predetermined
`alignment with respect to the first and second vertebral bod-
`ies. The gear member includes gear teeth extending around
`the perimeter of the gear member and the gear teeth are
`exposed to the exterior and configured to be accessible by a
`tool member at a plurality of angular positions around the
`perimeter.
`In one embodiment, the outer member includes a plurality
`oftool location holes for receiving a portion of a tool member
`therein to facilitate insertion, alignment and engagement of
`the tool member with the gear teeth. In another variation, the
`outer member includes a resiliently deformable portion for
`receiving the gear member thereon. In yet another embodi-
`ment, the inner member, outer member, and gear member
`may be made of a PEEK plastic material. In another embodi-
`ment, the device also 'ncludes a locking member for fixing the
`inner member with respect to the outer member.
`In one embodiment, the inner member is rotationally fixed
`with respect to the outer member. I11 one variation, the inner
`member includes a slot and a pi11 extends radially inward from
`the outer member to engage the slot to prevent rotational
`movement of the inner member with respect to the outer
`member.
`
`In another embodiment, the first end portion may comprise
`a first plate having a generally oblong shape when viewed
`perpendicular to the longitudinal axis, the first plate extend-
`ing a width distance along a long axis and a depth distance
`along a short axis, wherein the width distance is larger than
`the depth distance. Similarly, in another embodiment, the
`second end portion may comprise a second plate having a
`generally oblong shape when viewed perpendicular to the
`longitudinal axis, the secondplate extending a width distance
`along a long axis and a depth distance along a short axis,
`wherein the width distance is larger than the depth distance. In
`one variation, the first and second end plates include at least
`one bone engaging member extending longitudinally from
`the end plates. The bone engaging members may comprise
`metal spikes.
`In another variation, end portions have a thickness in the
`longitudinal direction and the thickness is variable in the
`anterior-posterior direction along the short axis. In one
`embodiment, the thickness varies gradually in the anterior-
`posterior direction such that the end portion defines a general
`wedge-shaped profile. In another embodiment, the end por-
`tion extends in the anterior-posterior direction from an ante-
`rior side to a posterior side and the first end portion has a first
`thickness at an anterior side and a second thickness at a
`
`posterior side, wherein the first thickness is greater than the
`second thickness. In yet another embodiment, the end portion
`includes a bone engaging surface and a plane tangent to the
`bone engaging surface intersects a plane normal to the longi-
`tudinal axis at a first angle. In one variation, the angle is
`between about -16 degrees and about 16 degrees.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention will be more readily understood with refer-
`ence to the embodiments thereof illustrated in the attached
`
`drawing figures, in which:
`FIG. 1 is a perspective view of a prosthetic device in accor-
`dance with an embodiment of the invention;
`FIG. 2 is an exploded view ofthe prosthetic device of FIG.
`
`1;
`
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`Exhibit 2007 Page 28
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`US 8,337,559 B2
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`3
`
`5
`
`FIG. 3 is a cross-sectional View of the prosthetic device of
`FIG. 1 taken along line 3-3 of FIG. 1;
`FIG. 4 is perspective View of an embodiment of an inner
`member of the prosthetic device of FIG. 1;
`FIG. 5 is perspective View of an embodiment of an outer
`member of the prosthetic device of FIG. 1;
`FIG. 6 is an end view of the prosthetic device of FIG. 1;
`FIG. 7 is an elevated side view ofone embodiment ofa gear
`member of the prosthetic device of FIG. 1;
`FIG. 8 is an end view of the gear member of FIG. 7;
`FIG. 9 is a cross-sectional view of the gear member of
`FIGS. 7 and 8 taken along line 9-9 of FIG. 8;
`FIG. 10 is a perspective of one embodiment of a tool
`according to the present invention;
`FIG. 11 is a perspective view of the tool of FIG. 10 shown is
`engaging an embodiment of an expandable prosthetic device
`according to the invention;
`FIG. 12 is a partial cross-sectional View ofthe combination
`of FIG. 11;
`FIG. 13 is a cross-sectional view ofanother embodiment of 20
`
`an outer member according to the invention;
`FIGS. 14-25 depict various alternate embodiments of
`expandable prosthetic devices according to the present inven-
`tion;
`FIG. 26 is a perspective view of one embodiment of 25
`another tool constructed according to the invention;
`FIG. 27 is a11 enlarged view of a portion of the tool of FIG.
`26;
`FIG. 28 is a perspective view of one embodiment of an
`assembly of the tool of FIG. 26 with one embodiment of an 30
`expandable prosthetic device according to the invention;
`FIG. 29 is an enlarged view of a portion ofthe assembly of
`FIG. 28;
`FIG. 30 is a perspective view of another embodiment of a
`tool according to the invention;
`FIG. 31 is a perspective View of another embodiment of a
`tool according to the invention;
`FIG. 32 is a perspective view of the tool of FIG. 31 shown
`adjacent a portion of a spine;
`FIG. 33 is a perspective view of another embodiment of an
`expandable prosthetic device according to the invention;
`FIG. 34 is a side View of another embodiment ofan expand-
`able prosthetic device according to the invention;
`FIG. 35 is a partial cross-sectional view ofanother embodi-
`ment of an expandable prosthetic device according to the
`invention;
`FIG. 36 is a partial perspective view of another embodi-
`ment of an expandable prosthetic device according to the
`invention;
`FIG. 37 is a partial side view of another embodiment of an
`expandaale prosthetic device according to the invention;
`FIG. 38 is a perspective view of another embodiment of an
`expandaale prosthetic device according to the invention;
`FIG. 39 is a cross-sectional view ofanother embodiment of
`
`an expar dable prosthetic device according to the invention;
`FIG. 40 is a cross-sectional view ofanother embodiment of
`
`55
`
`an expar dable prosthetic device according to the invention;
`FIGS. 41-44 are partial cross-sectional views of additional
`embodiments of endplate connection mechanisms
`for
`expandaale prosthetic devices according to the invention;
`FIG. 45 is a perspective view of another embodiment of an
`expandaale prosthetic device according to the invention; and
`FIG. 46 is a11 end view of and e11dplate of another embodi-
`ment of an expandable prosthetic device according to the
`invention.
`
`Throughout the drawing figures, it should be understood
`that like numerals refer to like features and structures.
`
`4
`DETAILED DESCRIPTION OF THE INVENTION
`
`Embodiments of the invention will now be described. The
`
`following de ailed description ofthe invention is not intended
`to be illustrative of all embodiments. In describing embodi-
`ments of the present
`invention, specific terminology is
`employed for the sake of clarity. However, the invention is not
`intended to be limited to the specific terminology so selected.
`It is to be understood that each specific element includes all
`technical equivalents that operate in a similar manner to
`accomplish a similar purpose.
`Referring to FIGS. 1-9, one embodiment of a11 expandable
`vertebral prosthetic device 10 is shown. Prosthesis 10 gener-
`ally comprises an inner member 12 which may be telescop-
`ingly received within an outer member 14. The prosthesis 10
`further comprises a gear member 16 generally configured to
`effect translation of inner member 12 with respect to outer
`member 14 and cause expansion ofprosthesis 10. Inner mem-
`ber 12, outer member 14, and gear member 16 are centered
`along a longitudinal axis 18 and define a hollow interior
`portion which may be filled with bone material, bone growth
`factors, bone morphogenic proteins, or other materials for
`encouraging bone growth, blood vessel growth or growth of
`other tissue through the many apertures in the device. In one
`embodiment, members 12, 14, a11d 16 are made of a polyether
`ether keto11e (PEEK) plastic material. Several known advan-
`tages of PEEK plastic material include that it is radiolucent
`and may 3e more easily sterilized than other plastics. In
`alternate e nbodiments, members 12, 14, and 1 6 may be n1ade
`of a biologically inert metal alloy or other suitable materials.
`Referring to FIGS. 1-4, inner member 12 l1as an endplate
`20 at a distal end 22 connected to a generally cylindrical body
`24 at a proximal end 26 a11d generally defines a hollow inte-
`rior portion extending axially therethrough. Body 24 of inner
`member 12 generally comprises a wall 27 with an inner
`surface 28 and an outer surface 30 and at least part of outer
`surface 30 includes external threads 32. Outer diameter 34 of
`
`body 24 is dimensioned to be cooperatively received within
`outer member 14.
`
`Outer member 14 l1as an endplate 40 at a proximal end 42
`connected to a generally cylindrical body 44 at a distal end 46
`and generally defines a hollow interior portion extending
`axially therethrough. Body 44 of outer member 14 generally
`comprises a wall 47 with a11 inner surface 48 and an outer
`surface 50. Inner diameter 52 of body 44 is dimensioned to
`cooperatively receive body 24 of inner member 12 within
`outer member 14. In this regard, im1er diameter 52 ofbody 44
`is greater than outer diameter 34 of body 24 of 1111161‘ member
`12. As shown in FIG. 1, outer member 14 may include one or
`more openings 53 to permit bone ingrowth. According to one
`embodiment, a lip 54 is formed around the exterior of the
`distal end 46 of body 44 and is configured to cooperatively fit
`with a portion of gear member 16. A plurality of relief spaces
`or slots 56 extending through wall 47 are angularly spaced
`around body 44 adjacent distal end 46 to facilitate a snapping
`engagement of lip 54 with gear member 16. In this regard,
`slots 56 allow distal end 46 to deform slightly and contract in
`the radial direction to accommodate gear member 16 to snap
`on to lip 54.
`As best seen in FIGS. 2-4, in one embodiment of a pros-
`thetic device 10, inner member 12 includes a plurality of
`longitudinal slots 36 extending radially through wall 27. Slots
`36 are angularly spaced around body 24 and extend longitu-
`dinally along wall 27. When inner member 12 is assembled
`within outer member 14, slots 36 are configured to engage at
`least one pin 38 protruding radially inward from the inner
`surface 48 of outer member 14 to prevent rotational move-
`
`Exhibit 2007 Page 29
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`Exhibit 2007 Page 29
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`US 8,337,559 B2
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`5
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`6
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`ment of inner member 12 with respect to outer member 14. In
`this regard, pin 38 may extend into one of slots 36 and may
`ride within one of the longitudinal slots 36 during expansion
`of the prosthetic device 10 to prevent rotation of inner mem-
`ber 12 with respect to outer member 14. In addition, pin 38
`may prevent inner member 12 from expanding or translating
`along axis 18 beyond a predetermined distance when pin 38
`bottoms out or contacts the proximal end 39 of the slot in
`which it is engaged.
`Referring to FIGS. 7-9, gear member 16 comprises a gen-
`erally hollow body 60 extending from a distal end 61 to a
`proximal end 63 with a helical thread 62 along at least part of
`an inner wall 64 and an array of gear teeth 66 along a portion
`of the exterior wall 68. Gear member 16 is generally config-
`ured to rotatably connect to distal end 46 of outer member 14
`and internal helical thread 62 is configured to engage external
`threads 32 of inner member 12 to cause translation of inner
`
`nember 12 with respect to outer member 14. In one embodi-
`nent, gear member 16 includes a cylindrical cutout feature 65
`extending arotmd the inner wall 64 to cooperatively receive
`lip 54 of outer member 14. In this regard, gear member 16
`nay rotate freely with respect to outer member 14 while being
`*etained fron1 longitudinal and lateral movement. In this
`regard, the aforementioned snap-on feature allows for the
`design and manufacture ofa relatively thin walled outer mem- 25
`361‘ 14 to facilitate the creation of a larger inner diameter of
`outer gear member 16 and inner member 12.As a result, more
`30116 growth stimulating material may be packed into the
`orosthetic device 10.Also, by creating a larger inner diameter
`of gear member 16 and inner member 12, a larger thread size
`for external thread 32 and intemal thread 62 may be utilized
`0 provide greater mechanical strength.
`Referring to FIG. 7, gear teeth 66 are positioned at an angle
`with respect to the proximal end 63 and extend around the
`entire periphery of a portion of exterior wall 68 to form a
`general frusto-conical gear teeth surface adjacent the proxi-
`mal end 63. The outer-most external diameter 67 of gear
`member 16 is sized to be the same as or slightly smaller than
`the smallest outer diameter of endplates 20, 40. In this regard,
`when prosthetic device 10 is viewed from the end in a plane
`perpendicularto longitudinal axis 18, as shown in FIG. 6, gear
`member 16 does not protrude radially outward from beyond
`the perimeter of endplates 20, 40. In one embodiment, the
`outer-most diameter of gear member 16 is substantially the
`same size as the smallest outer diameter of endplates 20, 40.
`As shown in FIG. 7, in one embodiment gear teeth 66 extend
`a width 69 in a generally radial direction and generally extend
`radially outward to the outer diameter of gear member 16. In
`this regard, teeth 66 may be designed to have a width 69 to
`accommodate the expected gear forces given the particular
`bevel gear ratio, types of material used, and desired overall
`inner diameter of prosthetic device 10. One skilled in the art
`will appreciate that the larger the outer diameter to which
`teeth 66 radially extend, the larger that teeth 66 may be
`designed while still maintaining the same gear ratio. In this
`regard, when teeth 66 are made larger, they generally have a
`better mechanical strength. Also, the ability to design larger,
`wider, and stronger teeth 66 is advantageous for embodiments
`wherein prosthesis 1 0 is made ofPEEK, other plastic, or other
`non-metallic materials that may have less mechanical
`strength than,
`for
`instance,
`titanium. Furthennore,
`as
`described in one embodiment, because the outer-most diam-
`eter of gear member 16 may be as large as the smallest outer
`diameter of endplates 20, 40, and teeth 66 extend radially to
`the outer-most diameter of gear member 16, a larger inner
`diameter of gear member 16 may be manufactured without
`compromising mechanical gear strength. As a result, a larger
`
`overall inner diameter ofprosthetic device 10 may be accom-
`modated which allows the packing of more bone material
`therein and facilitates bone fusion once prosthetic 10 is
`implanted.
`As seen in FIGS. 1 and 2, in one embodiment teeth 66 are
`substantially exposed to the exterior of prosthetic device 10.
`Because teeth 66 are exposed around the periphery, less mate-
`rial is needed to cover up the exposed teeth, which generally
`makes the prosthetic 1 0 lighter and easier to manufacture than
`prior art devices that require covering the gear teeth. In addi-
`tion, the gear member 16 is more easily visible by a surgeon
`and more readily accessible by a rotation tool than devices
`that hide or cover gear teeth. As discussed in more detail
`below, such a feature allows, inter alia, a tool to engage teeth
`66 at a multitude of angularpositions around the periphery of
`outer member 14 to provide a surgeon with various surgical
`options for insertion ofprosthetic device 10. Furthermore, the
`snap-on assembly feature of gear member 16 allows for the
`manufacture of thinner walled parts without sacrificing
`mechanical strength. As a result, prosthesis 10 is able to have
`a larger i11ternal diameter which allows n1ore space for bone-
`packing material.
`As shown in FIGS. 10-12, prosthesis 10 may be expanded
`by a tool 70 that includes a bevel gear 72 at its distal end. Tool
`70 extends along a tool axis 74 and in operation tool 70 is
`configured to engage prosthetic device 10 such that tool axis
`74 is generally perpendicular to longitudinal axis 18. Bevel
`gear 72 is configured to engage teeth 66 of gear member 16
`such that when bevel gear 72 is rotated about the axis of the
`tool, gear member 16 of prosthetic 10 is rotated about longi-
`tudinal axis 18 and inner member 12 translates along longi-
`tudinal axis 18 to expand prosthesis 10. In one embodiment,
`tool 70 may include a central shaft 76 having a threaded distal
`tip portion 78 that extends distally beyond bevel gear 72 to
`facilitate location and mounting oftool 70 with prosthetic 10.
`Threaded distal tip portion 78 may be configured to extend
`radially through a tool location hole 80 in outer member 14
`and threadedly engage a threaded hole 81 located on the inner
`surface 48 of wall 47 positioned diametrically opposite hole
`80 to fix the central shaft 76 of tool 70 to outer member 14.
`
`Once central shaft 76 is fixed to outer member 14, bevel gear
`72 may rotate with respect to central shaft 76 to effect rotation
`of gear member 16 and translation of inner member 12.
`Referring again to FIGS. 2 and 4, in one embodiment of
`prosthetic device 10 a plurality of mounting features or tool
`location holes 80, 82, 84 are provided along the outer surface
`50 of outer member 14. Tool location holes 80, 82, 84 may be
`spaced around outer surface 50 in a predetermined arrange-
`ment to allow insertion of prosthetic device 10 utilizing dif-
`ferent surgical approaches. For example, one skilled in the art
`will appreciate that holes 80, 82, 84 may be arranged to permit
`insertion through a lateral approach, anterolateral approach,
`or an anterior approach. As shown in FIG. 4, tool locatio11 hole
`80 is angularly located or positioned on wall 47 toward the
`front ofprosthetic 10 or toward the short end of end plates 20,
`40 to facilitate insertion of prosthetic device 10 into a patient
`via an anterior approach. Tool location hole 82 may be angu-
`larly located or positioned on wall 47 to be toward the side of
`prosthetic 10 or toward the long end of end plates 20, 40 to
`facilitate insertion of prosthetic device 10 into a patient via a
`lateral approach. In addition, a third tool location hole 84 may
`be angularly located or positioned to be between location
`holes 80 and 82 to facilitate insertion of prosthetic device 10
`through an anterolateral approach. As described previously,
`for each location hole 80, 82, 84, a corresponding threaded
`hole 81, 83, 85 may be formed on the inner surface 48 of wall
`
`Exhibit 2007 Page 30
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`US 8,337,559 B2
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`7
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`20
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`35
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`45
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`50
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`47 and positioned diametrically opposite the corresponding
`tool location hole to permit the threaded engagement of distal
`tip portion 78 of tool 70.
`As best seen in FIGS. 1, 2 and 4, a locking member 120
`may be provided to substantially restrict all relative move-
`ment between inner member 12 and outer member 14, when,
`for example, the desired expansion ofthe prosthetic device 10
`has been obtained. In one embodiment ofthe locking member
`120 according to the invention, a portion of locking member
`may protrude radially inward from the outer member 14 to
`engage the external surface 30 or thread 32 of inner member
`12 and lock or fix inner member 12 to outer member 14 by
`friction and/or deformation ofexternal threads 32. An internal
`
`locking screw 121 may be provided internal to locking mem-
`ber 120 to translate the locking member radially inward when
`the screw 121 is rotated. Screw 121 may be provided with a
`hexagonal head at its extenrally exposed end to facilitate
`engagement with an alien wrench or other tool to rotate screw
`121 and drive locking member 120 radially inward to lock
`inner member 12 in place. In one embodiment, a plurality of
`locking members 120, 122, 124 may be provided spaced
`around the periphery of outer member 14 such that a surgeon
`can easily extend the locking member when utilizing any one
`of the aforementioned tool location holes 80, 82, 84.
`Referring to FIGS. 1-9, one embodiment of end plates 20,
`40 is shown wherein each end plate has a generally oblong or
`elliptical shape when viewed from the end or perpendicular to
`the longitudinal axis 18. As shown in FIG. 6, each end plate
`20, 40 generally extends a width distance 90 (large outer
`diameter) along a long axis 92 in a medial-lateral direction
`and a length distance 94 (small outer diameter) along a short
`axis 96 i11 the anterior posterior direction, wherein width 90 is
`larger than the length 94. The oblong or elliptical shape ofend
`plates 20, 40 is designed to resemble or mimic the footprint of
`the vertebral body to which the end plates will engage. In this
`regard, end plates 20, 40 are configured to engage portions of
`the vertebrae in a predetermined orientation, namely with
`long axis 92 extending in a medial-lateral direction, to maxi-
`mize contact of the superior surface of the end plates 20, 40
`with bone.
`
`The dimensions of end plates 20, 40 can be varied to
`accommodate a patient’s anatomy. Typically, end plates 20,
`40 may have a width between about 14-32 mm (in the medial-
`lateral direction) and a length between about 12-25 mm (in
`the anterior-posterior direction).
`In some embodiments,
`implants 20, 40 have a wedge-shaped profile to accommodate
`the natural curvature of the spine. For example, as shown in
`FIG. 13, one embodiment of a wedge shape is shown wherein
`the end plate 130 has a gradual decrease in height from an
`anterior side 132 to a posterior side 134. In anatomical terms,
`the natural curvature of the lumbar spine is referred to as
`lordosis. When prosthetic device 10 is to be used i11 the
`lumbar region, the angle 136 formed by the wedge should be
`approximately between 4 degrees and 16 degrees so that the
`wedge shape is a lordotic shape which mimics the anatomy of
`the lumbar spine. In alternate embodiments, the wedge shape
`profile may result from a gradual increase in height from
`anterior side 132 to posterior side 134 to mimic the natural
`curvature i11 other regions ofthe spine. Thus, in other embodi-
`ments, angle 136 may be between about -4 degrees and -16
`degrees.
`As shown in FIGS. 1 and 2, a plurality ofmounting holes 98
`are spaced around the perimeter of each end plate 20, 40 for
`receiving insertable bone engaging members 100. In one
`embodiment, bone engaging members 100, comprise conical
`spikes 102 each having a cylindrical base portion 104 config-
`ured to fit within holes 98, for instance by press-fit. In alter-
`
`nate embodiments, d