USOO8721723B2
`
`(12) Unlted States Patent
`Hansell et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,721,723 B2
`May 13, 2014
`
`(54) EXPANDABLE VERTEBRAL PROSTHESIS
`
`-
`-
`(75) Inventors: Noah-Hansel], K1ng~ofPru551a, PA (US);
`Marcm Nlemle¢,Br1dgePOrLPA (Us);
`William S Rhoda, Media, PA (US)
`
`.
`_
`.
`(73) A551gnee. Globus Medlcal, Inc., Audubon, PA
`(Us)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U-S-C-154(b)by1081days-
`
`(21) Appl. No.: 12/352,163
`
`(22) Filed:
`
`Jan. 12,2009
`
`(65)
`
`.
`.
`.
`Prlor Publlcatlon Data
`us 2010/0179655 A1
`Jul. 15,2010
`
`(51) Int. Cl.
`A61F 2/44
`(52) US. Cl.
`USPC ..................................................... .. 623/1715
`
`(200601)
`
`(58) Field of Classi?cation Search
`_
`USPC ................ .. 623/17.11*17.16, 403/43, 44, 46,
`_
`_
`403/199'1’ 606/90
`See aPPheatlon ?le for complete seareh hIStOI'Y-
`_
`References Clted
`
`(56)
`
`US. PATENT DOCUMENTS
`
`4/1894 Ball ............................ .. 174/185
`518,213 A *
`1/1952 Stukenborg et a1. .
`403/46
`2,580,482 A *
`2,694,586 A * 11/1954 Smith ............ ..
`403/46
`2,794,474 A *
`6/1957 Stukenborg ..
`.. 411/217
`2,843,408 A *
`7/1958 Stukenborg ................... .. 403/46
`3,486,505 A 12/1969 Gordon
`3,719,186 A
`3/1973 Merig, Jr.
`3,741,205 A
`6/1973 Markolf
`3,848,601 A 11/1974 Ma
`
`9/ 1975 Long
`3,905,047 A
`3,916,907 A 11/1975 Peterson
`4,156,296 A
`5/1979 J hn
`4,177,524 A 12/1979 érellson
`4,289,123 A
`9/1981 Dunn
`4,309,777 A
`1/1982 Patil
`4,401,112 A *
`8/1983 Rezaian ...................... .. 606/279
`4,484,570 A 11/1984 Sutter
`4,501,269 A
`2/1985 Bagby
`4,512,038 A
`4/1985 Alexander
`4,537,185 A
`8/1985 StednitZ
`4,545,374 A 10/1985 Jacobson
`2
`\Igu
`,
`,
`aPP
`4,573,448 A
`3/1986 Kambin
`4,599,086 A
`7/1986 Doty
`4,611,581 A
`9/1986 Steffee
`4,611,582 A
`9/1986 Duff
`4,636,217 A
`1/1937 OgiIVie
`4,645,503 A
`2/1987 Lin
`4,657,550 A
`4/1987 Daher
`4,677,972 A
`7/1987 Tomier
`4,696,290 A
`909‘” Steffee
`4,743,256 A
`5/1988 Brantlgan
`(Continued)
`Primary Examiner * Mary Hoffman
`
`(57)
`
`ABSTRACT
`
`-
`-
`-
`An ex
`pandable prosthetlc 1mp1ant deV1ce for engagement
`between vertebrae generally comprising an inner member,
`outer member, gear member and a locking assembly posi
`tioned coaxial With respect to each other such that the inner
`and outer members are moveable relative to each other along
`an axis is disclosed. The gear member is axially ?xed to the
`outer member and freely rotatable With respect to the outer
`member and the gear member threadedly engages a threaded
`portion of the inner member to translate the inner member
`along the axis. The implant is con?gured to engage the ver
`tebrae in a predetermined alignment and the gear member
`includes gear teeth exposed to the exterior and con?gured to
`be accessible by a tool member at a plurality of angular
`positions around the perimeter of the implant device.
`
`7 Claims, 31 Drawing Sheets
`
`510
`
`514
`
`512
`
`520
`
`518
`
`Exhibit 2008 Page 1
`
`Globus Medical, Inc. v.
`Bonutti Skeletal Innovations LLC
`Case IPR2015-00417
`Bonutti Skeletal Innovations LLC - Ex. 2008
`
`

`
`US 8,721,723 B2
`Page2
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`7/1988 Buettner-Janz
`4,759 766 A
`9/1988 Ray
`4,7723287 A
`4/1989 Harms
`4820 305 A
`5/1989 Brantigan
`43834757 A
`9/1989 Shepperd
`4,863,476 A
`9/1989 Monson
`4863 477 A
`43874389 A 10/1989 Downey
`4,877,020 A 10/1989 Vich
`4,878,915 A 11/1989 Brantigan
`4,880,343 A 11/1989 Matsumoto
`4,892,546 A
`1/1990 KOtZ
`4,903,690 A
`2/1990 Campbell
`4,911,718 A
`3/1990 Lee
`4,927,421 A
`5/1990 Goble
`4,932,975 A
`6/1990 Main
`4,936,848 A
`6/1990 Bagby
`4,945,127 A
`7/1990 Kagawa
`4,950,258 A
`8/1990 Kawai
`4,950,269 A
`8/1990 Gaines
`4950 270 A
`8/1990 Bowman
`439613740 A 10/1990 Ray
`5,012,247 A
`4/1991 Dillrnan
`5,015,247 A
`5/1991 Michelson
`5,015,255 A
`5/1991 Kuslich
`5,019,108 A
`5/1991 Benin
`5,026,373 A
`6/1991 Ray
`5,042,588 A
`8/1991 Herchenbach etal. ..... .. 172/439
`5,055,104 A 10/1991 Ray
`5,057,109 A 10/1991 Olerud
`5,059,193 A 10/1991 Kuslich
`5,062,845 A 11/1991 Kuslich
`5,062,850 A 11/1991 MacMillan
`5,064,425 A 11/1991 Branemark
`5,071,437 A 12/1991 Steffee
`5,108,395 A
`4/1992 Lanrain
`5,123,926 A
`6/1992 Pisharocli
`5,139,499 A
`8/1992 Small
`5,147,402 A
`9/1992 Bohler
`5,147,404 A
`9/1992 Downey
`5,171,278 A 12/1992 Pisharocli
`5,171,280 A 12/1992 Baumgartner
`5,189,110 A
`2/1993 Ikemam
`5,192,237 A
`3/1993 Pegoraro
`5,192,326 A
`3/1993 B30
`5,192,327 A
`3/1993 Brantigan
`5,195,541 A
`3/1993 Obenchain
`5,236,460 A
`8/1993 Barber
`5,258,031 A 11/1993 Salib
`5,263,953 A 11/1993 Bagby
`5,290,289 A
`3/1994 Sanders
`5,290,312 A
`3/1994 Kojimoto
`5,300,076 A
`4/1994 Leriche
`5,306,310 A
`4/1994 Siebels
`5,313,962 A
`5/1994 Obenchain
`5,330,535 A
`7/1994 Moser
`5,336,223 A
`8/1994 Rogers
`5,354,302 A 10/1994 KO
`5,357,983 A 10/1994 Mathews
`5,358,524 A 10/1994 Richelsoph .............. .. 623/23.47
`5360 430 A 11/1994 Lin
`53364397 A 11/1994 Hayes
`5,382,226 A
`1/1995 Graharn
`5,390,683 A
`2/1995 Pisharocli
`5,395,317 A
`3/1995 Kambin
`5,413,602 A
`5/1995 MetZ-Stavenhagen
`5,423,816 A
`6/1995 Lin
`5,423,817 A
`6/1995 Lin
`5,425,772 A
`6/1995 Brantigan
`5,429,447 A
`7/1995 Wood
`5,431,658 A
`7/1995 Moskovich
`5,439,464 A
`8/1995 Shapiro
`5,443,514 A
`8/1995 Steffee
`5,443,515 A
`8/1995 Cohen
`5,445,639 A
`8/1995 Kuslich
`5,458,638 A 10/1995 Kuslich
`
`5,458,641 A 10/1995 Ramirez Jimenez
`5,458,642 A 10/1995 Beer
`5,480,442 A
`1/1996 BeltagIIOli
`5,482,417 A
`1/1996 Erickson
`5,484,437 A
`1/1996 Michelson
`5,489,307 A
`2/1996 Kuslich
`5,489,308 A
`2/1996 Kuslich
`5,505,732 A
`4/1996 Michelson
`5,522,899 A
`6/1996 Michelson
`5,533,863 A
`7/1996 Tornquist
`5,534,028 A
`7/1996 Bao etal.
`5,534,029 A
`7/1996 Shim
`5,534,031 A
`7/1996 Matsuzal?
`5,540,689 A
`7/1996 Sanders
`5,549,608 A
`8/1996 Errlco
`5,549,679 A
`8/1996 Kuslich
`5,554,191 A
`9/1996 Lahille
`5,562,736 A 10/1996 Ray
`5,569,176 A 10/1996 Graham
`5,571,109 A 11/1996 Beltagnoli
`5,571,189 A 11/1996 Kuslich
`5,571,192 A 11/1996 Schonhoffer
`5,575,790 A 11/1996 Chenet a1. .................... .. 606/60
`5,591,235 A
`1/1997 Kuslich
`5,603,713 A
`2/1997 Aust
`5,603,722 A
`2/1997 Phan _
`5,607,474 A
`3/1997 Athanaswu
`5,653,763 A
`8/1997 Errlco
`5,658,335 A
`8/1997 Allen
`5,658,336 A
`8/1997 Pisharodi
`5,665,122 A
`9/1997 Kambm
`5,674,286 A 10/1997 D’Aless10
`_
`5,674,295 A 10/1997 Ray
`5,676,699 A 10/1997 GOgOIGWSkl
`5,683,465 A 11/1997 Shlnn _
`5,693,100 A 12/1997 Plsharodl
`5,702,449 A 12/1997 McKay
`5,702,453 A 12/1997 Rabbe
`5,702,455 A 12/1997 Saggar
`5,713,841 A
`2/1998 Graham
`5,716,410 A
`2/1998 Wang
`5,716,416 A
`2/1998 L111
`_
`5,720,746 A
`2/1998 Soubelran
`5,723,013 A
`3/1998 1811118011
`5,749,916 A
`5/1998 Rlchelsoph
`5,765,957 A
`6/1998 Connell ........................ .. 403/46
`5,776,197 A
`7/1998 Rabbe
`5,776,198 A
`7/1998 Rabbe
`5,782,432 A
`7/1998 Renshaw
`5,800,433 A
`9/1998 B69281
`5,823,699 A 10/1998 Austln etal. ............. .. 403/109.1
`5,824,093 A 10/1998 Ray
`5,836,948 A 11/1998 Zucherman
`5,843,082 A 12/1998 Yuan
`5,860,977 A
`1/1999 Zu9herman
`5,861,035 A
`1/1999 Grlf?th
`5,863,297 A
`1/1999 Walter
`5,868,745 A
`2/1999 Alleyne
`5,868,746 A
`2/1999 Sewer
`5,876,404 A
`3/1999 Zucherman
`5,888,220 A
`3/1999 Felt
`5,888,224 A
`3/1999 Backers
`5,895,428 A
`4/1999 Betry
`5,899,904 A
`5/1999 Errlco
`5,899,905 A
`5/1999 Errico
`5,919,234 A
`7/1999 Lemperle
`5,954,744 A
`9/1999 Phan
`5,964,760 A 10/1999 R10helsoph
`5,976,186 A 11/1999 B99
`5,976,187 A 11/1999 Richelsoph
`5,980,522 A 11/1999 Koros
`5,980,572 A 11/1999 Kim
`5,984,967 A 11/1999 Zdeblick
`5,989,290 A 11/1999 Bieclerrnann etal. .... .. 623/17.11
`5,989,291 A 11/1999 Ralph
`6,015,436 A
`1/2000 Schonhoffer
`6,017,345 A
`1/2000 Richelsoph
`6,017,366 A
`1/2000 Berrnan
`6,019,793 A
`2/2000 Perren
`
`Exhibit 2008 Page 2
`
`

`
`US 8,721,723 B2
`Page3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2/2000 Vandewalle
`6,022,352 A
`2/2000 Schroeppel
`6,024,764 A
`3/2000 Yuan
`6036 693 A
`3/2000 Li
`6’039’761 A
`4/2000 Hochshuler
`6,045,579 A
`4/2000 Zucherman
`6’048’342 A
`5/2000 Znohernian
`6,068,630 A
`@2000 Wise et
`6’071’982 A
`60000 Zucherman
`63074390 A
`7/2000 Camino
`6086613 A
`7/2000 Zucherman
`6’090’112 A
`7/2000 Li
`630903996 A
`7/2000 McLeod
`6093 205 A
`8/2000 Kurz
`6,102,932 A
`8/2000 Lee
`6’102’933 A
`631263689 A 10/2000 Bratt
`6,127,597 A 10/2000 Beyar
`6,132,432 A 10/2000 Richelsoph
`6,132,465 A 10/2000 Ray
`6,136,031 A 10/2000 Middleton
`6,149,652 A 11/2000 Znohernian
`6,152,926 A 11/2000 Znohernian
`6,156,038 A 12/2000 Znohernian
`6,156,842 A 12/2000 Hoenig
`6,159,244 A 12/2000 Suddaby
`6,160,084 A 12/2000 Langer
`6,174,334 B1
`1/2001 Suddaby
`6,176,881 B1* 1/2001 Sohar etal. .............. .. 623/17.11
`6,177,883 B1
`1/2001 Jennetti
`6,179,873 B1
`1/2001 Zientek
`6,183,471 B1
`2/2001 Znohernian
`6,187,048 B1
`2/2001 Milner
`6,190,387 B1
`2/2001 Znohernian
`6,190,413 B1
`2/2001 Sutcliffe
`6,190,414 B1
`2/2001 Young
`6193720 Bl
`2/2001 Yuan
`6’193’756 B1
`2/2001 smder
`631933757 B1
`2/2001 Foley
`6,200,322 B1
`3/2001 Branch
`6,200,348 B1* 3/2001 Biedermann etal. .... .. 623/17.11
`6,206,883 B1
`3/2001 Tune
`6,206,923 B1
`3/2001 Boyd
`6,214,005 B1
`4/2001 Benzel
`6,217,579 B1
`4/2001 Koros
`6,221,075 B1
`4/2001 Torrnala
`6,235,030 B1
`5/2001 Znohernian
`6,238,397 B1
`5/2001 Znohernian
`6248131 B1
`6/2001 Felt
`632613289 B1
`7/2001 Levy
`6,264,695 B1
`7/2001 Stoy
`6,280,444 B1
`8/2001 Zucherman
`6,332,882 B1
`12/2001 Znohernian
`6,332,883 B1
`12/2001 Znohernian
`6,332,895 B1
`12/2001 Suddaby
`6,344,057 B1
`2/2002 Rabbe
`6,358,254 B1
`3/2002 Anderson
`6,368,351 B1
`4/2002 Glenn
`6,375,682 B1
`4/2002 Fleischmann
`6,379,355 B1
`4/2002 Znohernian
`6,395,031 B1
`5/2002 Foley
`6402 750 B1
`6/2002 Atkinson
`6’409’766 B1
`@2002 Brett
`6,419,676 B1
`7/2002 Znohernian
`634193677 B2
`7/2002 Zucherman
`6,425,919 B1
`7/2002 Lambrecht
`6,428,544 B1
`8/2002 Ralph
`6,436,102 Bl
`55/2002 Ralph
`6,436,140 B1
`8/2002 Liu
`6,436,143 B1
`8/2002 Ross
`6,443,989 B1
`9/2002 Jackson
`6,451,019 B1
`9/2002 Znohernian
`6,451,020 B1
`9/2002 Znohernian
`6,451,057 B1
`9/2002 Chen
`6,454,769 B2
`9/2002 Wagner
`6,454,806 B1
`9/2002 Cohen
`
`9/2002 Jackson
`6,454,807 B1
`10/2002 Ralph
`6,468,310 B1
`10/2002 R?lph
`6,471,725 B1
`6,478,796 B2 11/2002 Znohernian
`6,482,234 B1
`11/2002 Weber
`6,482,235 B1
`11/2002 Lambrecht
`6,485,517 B1
`11/2002 Michelson
`6,488,682 B2 12/2002 Kikuchi
`6,488,683 B2 12/2002 Lieberman
`6,488,710 B2 12/2002 Besselink
`6,491,724 B1
`12/2002 Ferree
`6,500,178 B2 12/2002 Znohernian
`6,500,205 B1
`12/2002 Michelson
`6,508,839 B1
`1/2003 Lambrecht
`6,514,256 B2
`2/2003 Znohernian
`6,520,991 B2
`2/2003 Huene
`6,524,341 B2* 2/2003 Lang et a1. ............... .. 623/1715
`6,527,806 B2
`3/2003 Ralph
`6,551,319 B2
`4/2003 Lieberrnan
`6,551,320 B2
`4/2003 Lieberrnan
`6,558,390 B2
`5/2003 Cragg
`6,562,074 B2
`5/2003 Gerbec
`6,569,203 B1* 5/2003 Keller ...................... .. 623/2347
`6,582,467 B1
`6/2003 Teitelbaum
`6,607,559 B2
`8/2003 Ralph
`6,613,089 B1
`9/2003 Estes
`6,648,917 B2 11/2003 Gerbec
`6,652,584 B2 11/2003 Michelson
`6,660,038 B2 12/2003 Boyer
`6,666,891 B2 12/2003 Boehm
`6,699,246 B2
`3/2004 Zucherman
`6,699,247 B2
`3/2004 lecherman
`6,709,458 B2
`3/2004 Michelson
`6,712,852 B1
`3/2004 Chung
`6,716,216 B1
`4/2004 Boucher
`6,716,247 B2
`4/2004 Michelson
`6,719,796 B2
`4/2004 Cohen
`6,723,126 B1
`4/2004 Berry
`6,730,088 B2* 5/2004 Yeh ............................. .. 606/247
`6,730,126 B2
`5/2004 Boehm
`6,733,534 B2
`5/2004 Sherman
`6,740,119 B2
`5/2004 Ralph etal.
`6,743,255 B2
`6/2004 Ferree
`6,749,614 B2
`6/2004 Teltelbaum
`6,752,832 B2
`6/2004 Neumann
`6,758,861 B2
`7/2004 Ralph
`6,758,863 B2
`7/2004 Estes
`6,764,491 B2
`7/2004 Frey
`6,764,515 B2
`7/2004 Ralph
`6,773,460 B2
`8/2004 Jackson
`6,776,781 B1
`8/2004 Uwaydah
`6,866,682 B1* 3/2005 Anet a1. .................. .. 623/1715
`6,902,579 B2
`6/2005 Harrns
`6,953,477 B2 10/2005 Bérry
`6,972,019 B2 12/2005 Michelson
`7,077,864 B2
`7/2006 Byrd
`7,135,043 B2 11/2006 Nakahm
`7,384,431 B2* 6/2008 Berry ....................... .. 623/1715
`7,442,209 B2 10/2008 Michelson
`7,494,296 B2* 2/2009 Stahle ...................... .. 403/1095
`7,588,573 B2
`9/2009 Berry
`7,641,693 B2* 1/2010 Gutlln et al. ............. .. 623/1715
`7,674,296 B2
`3/2010 Rhoda
`7,691,147 B2
`4/2010 Gutlln
`7,708,779 B2* 5/2010 Edie et al. ................ .. 623/1715
`7,758,648 B2
`7/2010 Castleman
`7,776,091 B2
`8/2010 Mastrorio
`7,794,502 B2
`9/2010 Michelson
`7,811,327 B2 10/2010 Hansen
`7,819,922 B2* 10/2010 Sweeney .................. .. 623/1716
`7,846,207 B2 12/2010 Lechmann
`7,862,616 B2
`1/2011 Leohrnann
`7,879,096 B2
`2/2011 Dickson etal. .......... .. 623/17.11
`7,909,870 B2* 3/2011 Kraus ...................... .. 623/17.11
`7,914,581 B2
`3/2011 Dickson
`7,972,363 B2
`7/2011 Moskowitz
`7,985,255 B2
`7/2011 Bray
`8,034,111 B2 10/2011 Hsu
`2002/0161441 A1* 10/2002 Lang etal. ............... .. 623/17.11
`
`Exhibit 2008 Page 3
`
`

`
`US 8,721,723 B2
`Page4
`
`(56)
`
`References Cited
`
`U_g_ PATENT DOCUMENTS
`
`2003/0045877 A1* 3/2003 Yeh “““““““““““““““““ H 606/61
`2003/0176925 A1* 9/2003 Paponneau n
`‘ 623/1716
`2004/0073314 A1* 4/2004 White 6161. ............. .. 623/17.15
`2005/0004572 A1* 1/2005 Biedermann 6161. ......... .. 606/61
`2006/0058877 A1
`3/2006 Gutlin
`2006/0100710 A1* 5/2006 Gutlin 6161. ............. .. 623/17.15
`2006/0200244 A1* 9/2006 Assaker
`. 623/17.15
`2006/0241762 A1* 10/2006 Kraus ...................... .. 623/17.11
`2006/0241770 A1 10/2006 Rhoda
`2006/0293755 A1 12/2006 Lindner
`2007/0191954 A1* 8/2007 Hansell et a1. ........... .. 623/17.15
`2007/0250171 A1 10/2007 Bonin
`2007/0255415 A1 11/2007 Edie
`2008/0015698 A1* 1/2008 Marino 6131. ........... .. 623/17.15
`2008/0027553 A1* 1/2008 Zucherman 6161. ..... .. 623/17.16
`2008/0183293 A1
`7/2008 Parry
`5333;353:333 31 13/5333 Egg
`
`2009/0112320 A1* 4/2009 Kraus
`. """"""""""" "
`4/2009 Refa‘
`2009/0112324 A1
`4/2009 Refai
`2009/0112325 A1
`2009/0138089 A1* 5/2009 Doubler et a1. .......... .. 623/1716
`
`623/1711
`'
`
`6/2009 Sommerich
`2009/0164017 A1
`7/2009 Tyber
`2009/0182430 A1
`7/2009 Wing
`2009/0192613 A1
`8/2009 Sledge
`2009/0210061 A1
`9/2009 MOSkOWitZ
`2009/0234455 A1
`2010/0094424 A1* 4/2010 Woodburn et 31. ....... .. 623/1716
`2010/0106251 A1* 4/2010 Kast ~~~~~~~~~~~~~~~~~~~~~~~~~ ~~ 623/1716
`2010/0145460 A1
`6/2010 McDonough
`2010/0179655 A1
`7/2010 Hansen
`2010/0249934 A1* 9/2010 Mélkent ~~~~~~~~~~~~~~~~~~~ ~~ 623/1716
`2010/0274357 A1 10/2010 Mlller
`2010/0280614 A1 11/2010 Cas?eman
`2010/0286787 A1 11/2010 VllllerS
`2010/0298942 A1 11/2010 Hansen
`2010/0324686 A1* 12/2010 Gemer ~~~~~~~~~~~~~~~~~~~~~ ~~ 623/1716
`2010/0324687 A1* 12/2010 Melkent etal. .
`623/1716
`2011/0015741 A1* 1/2011 Melkentetal. .
`623/17.11
`2011/0035009 A1* 2/2011 Sweeney ~~~~~~~~~~~~~~~~~~ ~~ 623/1711
`2011/0087328 A1
`4/2011 chkson
`58158123233 2‘}
`3/581} vth-?ab 1
`201170196493 Al
`8/2011 Emma
`
`1e en CC
`
`2011/0218631 A1* 9/2011 Woodburnetal. ....... .. 623/17.16
`2011/0251691 A1 10/2011 McLaughlin
`2011/0251692 A1 10/2011 McLaughlin
`
`* cited by examiner
`
`Exhibit 2008 Page 4
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 1 0131
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 5
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 2 0f 31
`
`US 8,721,723 B2
`
`2 G I F
`
`Exhibit 2008 Page 6
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 3 0f 31
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 7
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 4 0f 31
`
`US 8,721,723 B2
`
`60
`
`16
`J 61
`
`Exhibit 2008 Page 8
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 5 0f 31
`
`US 8,721,723 B2
`
`70
`
`Exhibit 2008 Page 9
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 6 0f 31
`
`US 8,721,723 B2
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`Exhibit 2008 Page 10
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`

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`US. Patent
`
`May 13, 2014
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`Sheet 7 0f 31
`
`US 8,721,723 B2
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`136
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`FIG. 13
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`132
`
`Exhibit 2008 Page 11
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 8 0f 31
`
`US 8,721,723 B2
`
`FIG.18
`
`Exhibit 2008 Page 12
`
`

`
`US. Patent
`
`May 13, 2014
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`Sheet 9 0f 31
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`US 8,721,723 B2
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`Exhibit 2008 Page 13
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`

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`US. Patent
`
`May 13, 2014
`
`Sheet 10 0f 31
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`US 8,721,723 B2
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`Exhibit 2008 Page 14
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`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 11 0131
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 15
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`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 12 or 31
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 16
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 13 0f 31
`
`US 8,721,723 B2
`
`FIG_ 28
`
`0
`
`Exhibit 2008 Page 17
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 14 0131
`
`US 8,721,723 B2
`
`FIG. 30
`
`300]
`
`Exhibit 2008 Page 18
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 15 0f 31
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 19
`
`

`
`US. Patent
`
`May 13, 2014
`
`Sheet 16 0131
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 20
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 17 of 31
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 21
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 18 of 31
`
`US 8,721,723 B2
`
`342
`
`360
`
`364
`
`382
`
`I7I(3;.341
`
`Exhibit 2008 Page 22
`
`Exhibit 2008 Page 22
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 19 of 31
`
`US 8,721,723 B2
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`404
`
`FIG. 35
`
`Exhibit 2008 Page 23
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`Exhibit 2008 Page 23
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 20 of 31
`
`US 8,721,723 B2
`
`
`410 Ilv//1';/IIII/1|
`
`‘U’
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`FIG. 36
`
`
`
`Exhibit 2008 Page 24
`
`Exhibit 2008 Page 24
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 21 of 31
`
`US 8,721,723 B2
`
`Exhibit 2008 Page 25
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`Exhibit 2008 Page 25
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`

`
`U.S. Patent
`
`May 13, 2014
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`Sheet 22 of 31
`
`US 8,721,723 B2
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`Exhibit 2008 Page 26
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`Exhibit 2008 Page 26
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 23 of 31
`
`US 8,721,723 B2
`
`344
`
`FIG. 41
`
`FIG. 43
`
`Fggg
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`
`342
`
`FIG. 42
`
`Exhibit 2008 Page 27
`
`Exhibit 2008 Page 27
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 24 of 31
`
`US 8,721,723 B2
`
`496
`
`492
`
`I:
`
`49
`
`492/D
`
`FIG. 45
`
`Exhibit 2008 Page 28
`
`Exhibit 2008 Page 28
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 25 of 31
`
`US 8,721,723 B2
`
`500
`
`504
`
`502
`
` 502
`
`FIG. 46
`
`Exhibit 2008 Page 29
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`Exhibit 2008 Page 29
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 26 of 31
`
`US 8,721,723 B2
`
`N_‘m
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`Exhibit 2008 Page 30
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`Exhibit 2008 Page 30
`
`
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 27 of 31
`
`US 8,721,723 B2
`
`522
`
`FIG.48
`
`Exhibit 2008 Page 31
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 28 of 31
`
`US 8,721,723 B2
`
`512
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`518
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`Exhibit 2008 Page 32
`
`Exhibit 2008 Page 32
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 29 of 31
`
`US 8,721,723 B2
`
`522
`
`524
`
`ONL
`
`0
`
`FIG.50
`
`Exhibit 2008 Page 33
`
`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 30 of 31
`
`US 8,721,723 B2
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`528
`
`FIG.51
`
`Exhibit 2008 Page 34
`
`Exhibit 2008 Page 34
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`

`
`U.S. Patent
`
`May 13, 2014
`
`Sheet 31 of 31
`
`US 8,721,723 B2
`
`Nmm
`
`mm.0E
`
`Em
`
`omm
`
`Em
`
`Exhibit 2008 Page 35
`
`

`
`US 8,721,723 B2
`
`2
`
`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 includes 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. In one variation, the inner
`member includes a slot and a pin 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 second plate 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 of the prosthetic device of FIG.
`
`1;
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`1
`EXPANDABLE VERTEBRAL PROSTHESIS
`
`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 bone cement or bone
`fragments to facilitate fusion in vivo. Some expandable pros-
`thesis may be adjusted prior to insertion into the cavity, while
`others may be adjusted in 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 permits 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 accommodate 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
`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 in 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.
`
`60
`
`65
`
`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 ofthe prosthetic device of FIG. 1;
`FIG. 7 is an elevated side view of one embodiment ofa gear
`member of the prosthetic device of FIG. 1;
`FIG. 8 is an end view ofthe gear member of FIG. 7;
`Exhibit 2008 Page 36
`
`Exhibit 2008 Page 36
`
`

`
`US 8,721,723 B2
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`3
`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
`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
`
`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
`another tool constructed according to the invention;
`FIG. 27 is an enlarged view ofa portion ofthe 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
`expandable prosthetic device according to the invention;
`FIG. 29 is an enlarged view of a portion of the 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
`expandable prosthetic device according to the invention;
`FIG. 38 is a perspective view of another embodiment of an
`expandable prosthetic device according to the invention;
`FIG. 39 is a cross-sectional view ofanother embodiment of
`
`an expandable prosthetic device according to the invention;
`FIG. 40 is a cross-sectional view ofanother embodiment of
`
`an expandable prosthetic device according to the invention;
`FIGS. 41-44 are partial cross-sectional views of additional
`embodiments of endplate connection mechanisms
`for
`expandable prosthetic devices according to the invention;
`FIG. 45 is a perspective view of another embodiment of an
`expandable prosthetic device according to the invention; and
`FIG. 46 is an end view of and endplate of another embodi-
`ment of an expandable prosthetic device according to the
`invention.
`
`FIGS. 47-52 illustrate the locking assemblies according to
`the present invention.
`Throughout the drawing figures, it should be understood
`that like numerals refer to like features and structures.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`Embodiments of the invention will now be described. The
`
`4
`
`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 an 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, and 16 are made of a polyether
`ether ketone (PEEK) plastic material. Several known advan-
`tages of PEEK plastic material include that it is radiolucent
`and may be more easily sterilized than other plastics. In
`alternate embodiments, members 12, 14, and 16 may be made
`of a biologically inert metal alloy or other suitable materials.
`Referring to FIGS. 1-4, inner member 12 has an endplate
`20 at a distal end 22 connected to a generally cylindrical body
`24 at a proximal end 26 and 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.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Outer member 14 has 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 an 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, inner diameter 52 ofbody 44
`is greater than outer diameter 34 of body 24 of inner 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-
`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
`following detailed description ofthe invention is not intended
`of the prosthetic device 10 to prevent rotation of inner mem-
`to be