`US008361156B2
`
`c12) United States Patent
`Curran et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,361,156 B2
`Jan.29,2013
`
`(54) SYSTEMS AND METHODS FOR SPINAL
`FUSION
`
`(75)
`
`Inventors: Matthew Curran, Carlsbad, CA (US);
`Mark Peterson, Medford, CA (US)
`
`(73) Assignee: NuVasive, Inc., San Diego, CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 13/441,092
`
`(22) Filed:
`
`Apr. 6, 2012
`
`(65)
`
`Prior Publication Data
`
`US 2012/0209388 Al
`
`Aug. 16, 2012
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 13/440,062, filed on
`Apr. 5, 2012, now Pat. No. 8,246,686, which is a
`continuation of application No. 13/079,645, filed on
`Apr. 4, 2011, now Pat. No. 8,187,334, which is a
`continuation of application No. 11/093,409, filed on
`Mar. 29, 2005, now Pat. No. 7,918,891.
`
`(60) Provisional application No. 60/557,536, filed on Mar.
`29, 2004.
`
`(51)
`
`Int. Cl.
`A61F 2144
`(2006.01)
`(52) U.S. Cl. .................................................... 623/17.16
`( 58) Field of Classification Search . ... . 623/17 .11-17 .19
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`3,486,505 A *
`12/1969 Morrison ........................ 606190
`3,518,993 A *
`7/1970 Blake ............................ 606/142
`911971 Gilbert
`3,604,487 A
`3,745,995 A *
`7I1973 Kraus ............................... 60212
`
`3,848,601 A * 1111974
`606/86 A
`Maet al.
`3,867,728 A * 2/1975
`........... 623/17.16
`Stubstad et al.
`4,026,304 A * 5/1977
`Levy ............................... 607/51
`4,026,305 A * 5/1977
`Brownlee et al. ............... 607/32
`4,349,921 A
`9/1982
`Kuntz
`4,454,374 A * 6/1984
`174/68.3
`Pollack .
`4,501,269 A * 2/1985
`Bagby ........................... 606/279
`Jacobson
`4,545,374 A
`10/1985
`4,646,738 A * 3/1987
`Trott ............................. 606/170
`4,657,550 A * 4/1987
`Daher ........................ 623/17.11
`4,743,256 A * 5/1988
`Brantigan
`128/898
`1111988
`Allen
`4,781,591 A
`4,834,757 A
`5/1989
`Brantigan
`Vi ch
`4,877,020 A
`10/1989
`4,878,915 A
`Brantigan
`1111989
`Main et al.
`4,932,975 A
`6/1990
`Mcintyre
`4,950,296 A
`8/1990
`Ray et al.
`4,961,740 A
`10/1990
`Herzon
`4,962,766 A
`10/1990
`(Continued)
`
`CA
`EP
`
`FOREIGN PATENT DOCUMENTS
`2015507
`111999
`369603
`5/1990
`(Continued)
`
`OTHER PUBLICATIONS
`
`Alleyne et al., "Current and future approaches to lumbar disc surgery:
`A literature review," Medscape Orthopedics & Sports Medicne, 1,
`[ www.medscape.com/Medscape/OrthoSportsMed/ 1997 /v. 0l.n111 ...
`/mos3057], (1997).
`
`(Continued)
`
`Primary Examiner - Ellen C Hammond
`Assistant Examiner - Stuart S Bray
`(74) Attorney, Agent, or Firm - Fish & Richardson P.C.
`
`ABSTRACT
`(57)
`A system and method for spinal fusion comprising a spinal
`fusion implant of non-bone construction releasably coupled
`to an insertion instrument dimensioned to introduce the spinal
`fusion implant into any of a variety of spinal target sites.
`
`27 Claims, 20 Drawing Sheets
`
`4
`
`.j
`
`< ••
`... ····'
`
`"'.·
`
`}l
`//
`
`/
`
`4
`
`'<
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 1 of 30
`
`
`
`US 8,361,156 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`5,015,247 A
`5/1991 Michelson
`5,026,373 A
`6/1991 Ray et al.
`5,047,055 A
`9/1991 Bao et al.
`5,055,104 A
`10/1991 Ray
`5,062,845 A
`1111991 Kuslich et al.
`12/1991 Steffee
`5,071,437 A
`5,092,572 A
`3/1992 Litwak et al.
`5,133,717 A
`7/1992 Chopin
`5,133,755 A
`7/1992 Brekke
`12/1992 Pisharodi
`5,171,278 A
`5,192,327 A
`3/1993 Brantigan
`5,217,497 A
`6/1993 Mehdian
`1111993 Bagby
`5,263,953 A
`5,269,785 A
`12/1993 Bonutti
`5,284,153 A
`2/1994 Raymond et al.
`5,290,494 A
`3/1994 Coombes et al.
`5,300,076 A
`4/1994 Leriche
`5,304,210 A
`4/1994 Crook
`5,306,307 A
`4/1994 Senter et al.
`5,306,309 A
`4/1994 Wagner et al.
`5,322,505 A
`6/1994 Krause et al.
`5,334,205 A
`8/1994 Cain
`5,336,223 A
`8/1994 Rogers
`5,364,400 A
`1111994 Rego, Jr. et al.
`5,395,372 A
`3/1995 Holt et al.
`5,397,363 A
`3/1995 Gel bard
`5,397,364 A
`3/1995 Kozak
`5,405,391 A
`4/1995 Henderson et al.
`5,413,602 A
`5/1995 Metz-Stavenhagen
`5,425,772 A
`6/1995 Brantigan
`5,431,658 A
`7/1995 Moskovich
`8/1995 Steffee
`5,443,514 A
`5,443,515 A
`8/1995 Cohen et al.
`5,445,639 A
`8/1995 Kuslich et al.
`5,454,811 A
`10/1995 Huebner
`5,458,638 A
`10/1995 Kuslich et al.
`5,484,403 A
`111996 Yoakum et al.
`111996 Michelson
`5,484,437 A
`5,489,307 A
`2/1996 Kuslich et al.
`5,489,308 A
`2/1996 Kuslich et al.
`5,514,180 A
`5/1996 Heggeness et al.
`6/1996 Scopelianos
`5,522,879 A
`5,522,899 A
`6/1996 Michelson
`5,524,624 A
`6/1996 Tepper et al.
`5,527,312 A
`6/1996 Ray
`5,534,030 A
`7/1996 Navarro et al.
`5,540,688 A
`7/1996 Navas
`5,545,222 A
`8/1996 Bonutti
`5,562,736 A
`10/1996 Ray et al.
`5,565,005 A
`10/1996 Erickson et al.
`1111996 Ulrich et al.
`5,571,190 A
`1111996 Schonhoffer
`5,571,192 A
`111997 Michelson
`5,593,409 A
`5,607,424 A
`3/1997 Tropiano
`5,609,636 A
`3/1997 Kohrs et al.
`5,611,800 A
`3/1997 Davis et al.
`5,611,810 A
`3/1997 Arnold et al.
`5/1997 Scarborough et al.
`5,632,747 A
`5,645,596 A
`7/1997 Kim et al.
`5,645,598 A
`7/1997 Brosnahan et al.
`8/1997 Pisharodi
`5,653,761 A
`8/1997 Pisharodi
`5,653,762 A
`8/1997 Pisharodi
`5,658,336 A
`5,658,337 A
`8/1997 Kohrs et al.
`5,662,710 A
`9/1997 Bonutti
`5,665,122 A
`9/1997 Kamb in
`5,669,909 A
`9/1997 Zdeblick et al.
`5,676,703 A
`10/1997 Gel bard
`1111997 Rinner
`5,683,394 A
`5,683,400 A
`1111997 McGuire
`1111997 Wagner et al.
`5,683,464 A
`1111997 Asher et al.
`5,690,629 A
`5,700,264 A
`12/1997 Zucherman et al.
`5,700,291 A
`12/1997 Kuslich et al.
`5,700,292 A
`12/1997 Margulies
`5,702,449 A
`12/1997 McKay
`5,702,451 A
`12/1997 Biedermann et al.
`5,702,453 A
`12/1997 Rabbe et al.
`
`12/1997 Baumgartner
`5,702,454 A
`12/1997 Sag gar
`5,702,455 A
`12/1997 Yamamichi
`5,703,451 A
`111998 Sevrain et al.
`5,707,373 A
`111998 Patat et al.
`5,711,957 A
`2/1998 Steffee
`5,716,415 A
`2/1998 Kuslich et al.
`5,720,748 A
`2/1998 Jackson
`5,720,751 A
`3/1998 Stroever et al.
`5,728,159 A
`4/1998 Michelson
`5,741,253 A
`4/1998 Moskovitz et al.
`5,741,261 A
`5/1998 Baumgartner
`5,755,797 A
`6/1998 Henry et al.
`5,766,252 A
`6/1998 Michelson
`5,772,661 A
`7/1998 Raymond et al.
`5,775,331 A
`7/1998 Henstra
`5,775,797 A
`7/1998 Nightengale
`5,779,642 A
`7/1998 Farris
`5,782,830 A
`7/1998 Zdeblick et al.
`5,782,919 A
`7/1998 Michelson
`5,785,710 A
`8/1998 Michelson
`5,797,909 A
`9/1998 Bao et al.
`5,800,549 A
`9/1998 Sertich
`5,800,550 A
`9/1998 Grivas et al.
`5,814,084 A
`12/1998 Trott
`5,851,208 A
`111999 Michelson
`5,860,973 A
`2/1999 Thalgott
`5,865,845 A
`2/1999 Baker
`5,865,848 A
`3/1999 Winslow et al.
`5,885,299 A
`3/1999 Bonutti
`5,888,219 A
`3/1999 Beckers et al.
`5,888,224 A
`4/1999 Pisharodi
`5,893,890 A
`5/1999 Errico et al.
`5,904,719 A
`6/1999 Stevenson et al.
`5,910,315 A
`8/1999 Stevens
`5,942,698 A
`9/1999 Rosenlicht
`5,954,769 A
`10/1999 Winslow
`5,968,098 A
`1111999 Ouchi
`5,993,474 A
`12/1999 Kobayashi et al.
`6,003,426 A
`12/1999 Castro et al.
`6,004,326 A
`12/1999 Stone
`6,008,433 A
`1/2000 Schonhoffer
`6,015,436 A
`3/2000 Winslow et al.
`6,033,405 A
`3/2000 Li et al.
`6,039,761 A
`3/2000 Ray
`6,042,582 A
`412000 Scarborough et al.
`6,045,580 A
`412000 Zucherman et al.
`6,048,342 A
`512000 Schlapfer et al.
`6,059,829 A
`512000 Winslow
`6,063,088 A
`712000 Winslow et al.
`6,083,225 A
`8/2000 Nicholson et al.
`6,096,080 A
`6,102,948 A
`8/2000 Brosnahan, III
`912000 Michelson
`6,120,503 A
`912000 Kohrs et al.
`6,120,506 A
`10/2000 Bonutti
`6,132,472 A
`11/2000 Paul et al.
`6,143,033 A
`12/2000 Boriani et al.
`6,159,211 A
`12/2000 Urbahns et al.
`6,159,215 A
`2/2001 Studer et al.
`6,193,756 Bl
`3/2001 Anderson et al.
`6,200,347 Bl
`5/2001 Michelson
`6,224,607 Bl
`5/2001 Kohrs
`6,224,631 Bl
`6/2001 Nicholson et al.
`6,241,769 Bl
`6/2001 Gresser et al.
`6,241,771 Bl
`6/2001 Marino et al.
`6,251,140 Bl
`6,258,125 Bl
`7/2001 Paul et al.
`8/2001 Boyle et al.
`6,277,149 Bl
`6,304,487 Bl * 10/2001 Pawletko et al.
`1112001 Carignan et al.
`6,319,257 Bl
`6,371,989 Bl
`412002 Chauvin et al.
`6,383,221 Bl
`512002 Scarborough et al.
`6,409,766 Bl
`612002 Brett
`6,425,772 Bl
`712002 Bernier et al.
`6,432,140 Bl
`8/2002 Lin
`6,440,142 Bl
`8/2002 Ralph et al.
`6,442,814 Bl
`912002 Landry et al.
`6,447,547 Bl
`912002 Michelson
`6,454,806 Bl
`912002 Cohen et al.
`10/2002 Boyd et al.
`6,468,311 B2
`
`........ 365/185.22
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 2 of 30
`
`
`
`US 8,361,156 B2
`Page 3
`
`6,491,724 Bl
`6,527,773 Bl
`D472,634 S
`D473,650 S
`6,547,823 B2
`6,595,998 B2
`6,626,905 Bl
`6,635,086 B2
`6,648,895 B2
`6,672,019 Bl
`6,676,703 B2
`6,706,067 B2
`6,743,255 B2
`6,746,484 Bl
`6,755,841 B2
`6,761,739 B2
`6,824,564 B2
`D503,801 S
`6,923,814 Bl
`6,942,698 Bl
`6,964,687 Bl
`6,979,353 B2
`6,984,245 B2
`6,986,788 B2
`6,989,031 B2
`7,018,416 B2
`D530,423 S
`8,021,430 B2
`8,246,686 Bl *
`2002/0058950 Al
`2003/0105528 Al
`2003/0139812 Al
`200410153155 Al
`2005/0197702 Al
`2007/0191945 Al
`2008/0015701 Al *
`2012/0078374 Al*
`
`12/2002 Ferree
`3/2003 Lin et al.
`4/2003 Anderson
`4/2003 Anderson
`4/2003 Scarborough et al.
`7/2003 Johnson et al.
`9/2003 Schmiel et al.
`10/2003 Lin
`1112003 Burkus et al.
`112004 Wenz
`112004 Biscup
`3/2004 Shimp et al.
`6/2004 Ferree
`6/2004 Liu et al.
`6/2004 Fraser et al.
`7/2004 Shepard
`1112004 Crozet
`412005 Jackson
`8/2005 Hildebrand et al.
`912005 Jackson
`1112005 Bernard et al.
`12/2005 Bresina
`112006 McGahan et al.
`112006 Paul et al.
`112006 Michelson
`3/2006 Hanson et al.
`10/2006 Miles et al.
`912011 Michelson
`8/2012 Curran et al.
`512002 Winterbottom et al.
`6/2003 Shimp et al.
`7/2003 Garcia et al.
`8/2004 Chung et al.
`912005 Coppes et al.
`8/2007 Yu et al.
`112008 Garcia et al.
`3/2012 Villiers et al.
`
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`FOREIGN PATENT DOCUMENTS
`517030
`5/1992
`667127
`8/1995
`706876
`4/1996
`716840
`6/1996
`737448
`10/1996
`796593
`9/1997
`880938
`2/1998
`809974
`4/1998
`809975
`4/1998
`811356
`4/1998
`90/00037
`111990
`91106261
`5/1991
`92/14423
`9/1992
`93/01771
`2/1993
`94/04100
`3/1994
`94/10928
`5/1994
`95/01810
`111995
`95/08306
`3/1995
`96/08205
`3/1996
`96/17564
`3/1996
`96/41582
`12/1996
`97/20513
`6/1997
`97/33525
`9/1997
`
`623/17.16
`
`623/17.16
`623/17.16
`
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`97/37620
`98/09586
`98/14142
`98/17208
`98/25539
`99/08627
`99/38461
`00/45712
`00/45713
`01141681
`01149333
`
`10/1997
`3/1998
`4/1998
`4/1998
`6/1998
`2/1999
`8/1999
`8/2000
`8/2000
`6/2001
`712001
`
`OTHER PUBLICATIONS
`
`Benini et al., "Undercutting decompression and posterior fusion with
`translaminar facet screw fixation in degenerative lumbar spinal
`stenosis: Technique and results," Neuro-Orthopedics, 17I18, 159-172
`(1995).
`Kambin et al., "History and current status of percutaneous
`arthroscopic disc surgery," Spine, 21(24S): 57S-6 l S ( 1996).
`Stein et al., "Percutaneous facet joint fusion: Preliminary experi(cid:173)
`ence," Journal of Vascular and Interventional Radiology, 4:69-74
`(1993).
`Vamvanij et al., "Surgical treatment of internal disc disruption: An
`outcome study of four fusion techniques," Journal of Spinal Disor(cid:173)
`ders, 11(5):375-382 (1998).
`Baulot et al.,
`spondylodesis by
`"Complementary anterior
`thoracoscopy. Technical note regarding an observation," Lyon Surg.,
`90(5):347-351 (1994).
`Berry et al., "A morphometric study of human lumbar and selected
`thoracic vertebrae, study of selected vertebrae," Spine 12( 4):362-367
`(1996).
`Crock, "A Short Practice of Spinal Surgery," Second, revised edition,
`published by Springer-Verlag/Wein, New York (1993).
`Crock, "Anterior Lumbar Interbody Fusion," Clinical Orthopaedics
`& Related Research, Marshall R. Urist, Editor-in-Chief, J. B. Lip(cid:173)
`pincott Company (1982).
`Edeland, "Some additional suggestions for an intervertebral disc
`prosthesis," Journal of Biomedical Engineering, 7:57-62 (1985).
`Kemp, "Anterior fusion of the spine for infective lesions in adults,"
`Journal of Bone & Joint Surgery, 55B(4):715-734 (1973).
`NuVasive, Inc., Corrected Final Invalidity Contentions Regarding
`US 5,860,973, US 6,592,586 and US 6,945,933 filed in the United
`States District Court, Southern District of California on Jun. 14, 2010
`(and 23 appendices).
`CoRoent™ Marketing Brochure (9004001 A.O), NuVasive, Inc.,
`2004, 2 pages.
`CoRoent™ Marketing Brochure (9004001 C.O), NuVasive, Inc.,
`2005, 2 pages.
`CoRoent™ XL & XLR Marketing Brochure (9004225 A.O),
`NuVasive, Inc., 2005, 2 pages.
`CoRoent® XL & XLR Marketing Brochure (9004225 B.O),
`NuVasive, Inc., 2006, 2 pages.
`CoRoent® XL & XLR Marketing Brochure (9004225 C.O),
`NuVasive, Inc., 2007, 2 pages.
`CoRoent® XL Marketing Brochure (9500039 A.O), NuVasive, Inc.,
`2006, 8 pages.
`* cited by examiner
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 3 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 1of20
`
`US 8,361,156 B2
`
`:FIG. 1
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 4 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 2of20
`
`US 8,361,156 B2
`
`... ,. ·~·.,····--· .. ~
`
`~'{l .,,.,,
`-..,..,,,,,....,
`
`.... ---·~ 0
`•. ,.~~~--.,.-:;., ..... ·'''·''
`
`y-~1
`~
`
`go)
`
`l
`
`/..
`
`<:::)
`
`{/,..,8
`.....
`---.. ....,
`
`:~
`
`\/
`\.···)·, .. :>.,,_.., .
`
`................
`
`H
`
`. /
`
`(
`.. l
`,~~--······"
`
`f
`~
`.... , ...... -.•..-.•'•'··
`
`FIG.2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 5 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 3of20
`
`US 8,361,156 B2
`
`::··
`
`FIG . ..3
`
`.Et
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 6 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 4of20
`
`US 8,361,156 B2
`
`)
`! !
`
`FIG. 4
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 7 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 5of20
`
`US 8,361,156 B2
`
`FIG. 5
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 8 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 6of20
`
`US 8,361,156 B2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 9 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 7of20
`
`US 8,361,156 B2
`
`FIG. 7
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 10 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 8of20
`
`US 8,361,156 B2
`
`·······.
`
`. .. : ......
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 11 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 9of20
`
`US 8,361,156 B2
`
`/7-y .... -,,.,.,.;...,.,,~~"--··
`f.-1 r
`i.u.,.
`
`.. ,., 8;
`
`·~c~.· ~ 1£\
`
`"-~ 38 ~~ .. J,·.~.·:·f.~~·····\ .. "··~,:·-----.J
`\ ~
`C"" .. ",.,.,.,,,;
`\., ...
`64
`
`("""':....,._,, .. ._, ... ~
`
`l
`
`\
`
`42
`
`--.. .. "~\-
`
`\
`
`.... <
`
`44
`
`·17:·~· (·~~ 9
`.I~ .I.
`.'1«
`,
`
`·.
`
`\.
`,:-·""",.)
`'>.
`lA
`
`\
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 12 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 10 of 20
`
`US 8,361,156 B2
`
`FIG. 10
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 13 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 11 of 20
`
`US 8,361,156 B2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 14 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 12 of 20
`
`US 8,361,156 B2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 15 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 13 of 20
`
`US 8,361,156 B2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 16 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 14 of 20
`
`US 8,361,156 B2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 17 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 15 of 20
`
`US 8,361,156 B2
`
`110
`
`FIG. 15
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 18 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 16 of 20
`
`US 8,361,156 B2
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 19 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 17 of 20
`
`US 8,361,156 B2
`
`41
`
`~
`\~.:-.......
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 20 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 18 of 20
`
`US 8,361,156 B2
`
`........ •··•·
`· ..... .
`
`4
`
`31.
`
`4
`/ /
`
`4
`
`"' ·'>·'<
`: ....... .
`-:.; ~
`
`.. .......... ..
`
`...... ··
`
`=:.. ........ .
`
`//
`
`3!
`
`4
`
`4
`
`4
`
`FIG. 19
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 21 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 19 of 20
`
`US 8,361,156 B2
`
`t;' ·1· i"""' 1. 'l
`J ... \ .. $v -~:J
`
`4
`
`4
`
`l
`
`....... .-···10
`~·: ....
`
`< /
`
`4
`
`1
`
`4
`
`31
`<
`/
`
`9
`I
`l
`! <
`
`4
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 22 of 30
`
`
`
`U.S. Patent
`
`Jan.29,2013
`
`Sheet 20 of 20
`
`US 8,361,156 B2
`
`31
`
`4
`
`}l
`/
`
`., '°l'
`1<~8ȣ. .......
`I I'·*':.: ·"*·"=
`
`~/[·(·:, . .,_ ·~
`1 . . . :$4- .... ,
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 23 of 30
`
`
`
`US 8,361,156 B2
`
`1
`SYSTEMS AND METHODS FOR SPINAL
`FUSION
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application is continuation of U.S. patent application
`Ser. No. 13/440,062 filed Apr. 5, 2012, which is a continua(cid:173)
`tion of U.S. patent application Ser. No. 13/079,645 filed Apr.
`4, 2011, which is continuation of U.S. patent application Ser.
`No. 11/093,409 filed Mar. 29, 2005 (now U.S. Pat. No. 7,918,
`891 ), which claims the benefit of the filing date under 35 USC
`119( e) of United States Provisional Application entitled
`"Systems and Methods for Spinal Fusion," Ser. No. 60/557,
`536 filed Mar. 29, 2004, the entire contents of these prior
`applications are incorporated herein by reference.
`
`BACKGROUND OF THE INVENTION
`
`2
`methods involving the use of a spinal fusion implant of non(cid:173)
`bone construction. The non-bone construction of the spinal
`fusion implant of the present invention overcomes the draw(cid:173)
`backs of the prior art in that it is not supply limited (as with
`allograft) and does not require harvesting bone from the
`patient (as with autograft). The spinal fusion implant of the
`present invention may be comprised of any suitable non-bone
`composition, including but not limited to polymer composi(cid:173)
`tions (e.g. poly-ether-ether-ketone (PEEK) and/orpoly-ether-
`10 ketone-ketone (PEKK)), ceramic, metal or any combination
`of these materials.
`The spinal fusion implant of the present invention may be
`provided in any number of suitable shapes and sizes depend(cid:173)
`ing upon the particular surgical procedure or need. The spinal
`15 fusion implant of the present invention may be dimensioned
`for use in the cervical and/or lumbar spine without departing
`from the scope of the present invention. For lumbar fusion,
`the spinal fusion implant of the present invention may be
`dimensioned, by way of example only, having a width rang-
`20 ing between 9 and 18 mm, a height ranging between 8 and 16
`mm, and a length ranging between 25 and 45 mm. For cervi(cid:173)
`cal fusion, the spinal fusion implant of the present invention
`may be dimensioned, by way of example only, having a width
`about 11 mm, a height ranging between 5 and 12 mm, and a
`25 length about 14 mm.
`The spinal fusion implant of the present invention may be
`provided with any number of additional features for promot(cid:173)
`ing fusion, such as apertures extending between the upper and
`lower vertebral bodies which allow a boney bridge to form
`30 through the spinal fusion implant of the present invention.
`Such fusion-promoting apertures may be dimensioned to
`receive any number of suitable osteoinductive agents, includ(cid:173)
`ing but not limited to bone morphogenic protein (BMP) and
`bio-resorbable polymers, including but not limited to any of a
`35 variety of poly (D,L-lactide-co-glycolide) based polymers.
`The spinal fusion implant of the present invention is prefer(cid:173)
`ably equipped with one or more lateral openings which aid it
`provides in visualization at the time of implantation and at
`subsequent clinical evaluations.
`The spinal fusion implant of the present invention may be
`provided with any number of suitable anti-migration features
`to prevent spinal fusion implant from migrating or moving
`from the disc space after implantation. Suitable anti-migra(cid:173)
`tion features may include, but are not necessarily limited to,
`45 angled teeth formed along the upper and/or lower surfaces of
`the spinal fusion implant and/or spike elements disposed
`partially within and partially outside the upper and/or lower
`surfaces of the spinal fusion implant. Such anti-migration
`features provide the additional benefit of increasing the over-
`50 all surface area between the spinal fusion implant of the
`present invention and the adjacent vertebrae, which promotes
`overall bone fusion rates.
`The spinal fusion implant of the present invention may be
`provided with any number of features for enhancing the visu-
`55 alization of the implant during and/or after implantation into
`a spinal target site. According to one aspect of the present
`invention, such visualization enhancement features may take
`the form of the spike elements used for anti-migration, which
`may be manufactured from any of a variety of suitable mate-
`60 rials, including but not limited to a metal, ceramic, and/or
`polymer material, preferably having radiopaque characteris(cid:173)
`tics. The spike elements may also take any of a variety of
`suitable shapes, including but not limited to a generally elon(cid:173)
`gated element disposed within the implant such that the ends
`65 thereof extend generally perpendicularly from the upper and/
`or lower surfaces of the implant. The spike elements may each
`comprise a unitary element extending through upper and
`
`I. Field of the Invention
`The present invention relates generally to spinal surgery
`and, more particularly, to a system and method for spinal
`fusion comprising a spinal fusion implant of non-bone con(cid:173)
`struction releasably coupled to an insertion instrument
`dimensioned to introduce the spinal fusion implant into any of
`a variety of spinal target sites.
`II. Discussion of the Prior Art
`Currently there are nearly 500,000 spine lumbar and cer(cid:173)
`vical fusion procedures performed each year in the United
`States. Such procedures are commonly performed to correct
`problems, such as chronic back or neck pain, which result
`from degenerated intervertebral discs or trauma. Generally,
`spinal fusion procedures involve removing some or all of the
`diseased or damaged disc, and inserting one or more inter(cid:173)
`vertebral implants into the resulting disc space. Introducing
`the intervertebral implant serves to restore the height between
`adjacent vertebrae ("disc height"), which reduces ifnot elimi(cid:173)
`nates neural impingement commonly associated with a dam(cid:173)
`aged or diseased disc.
`Autologous bone grafts are widely used intervertebral
`implant for lumbar fusion. Autologous bone grafts are
`obtained by harvesting a section ofbone from the iliac crest of 40
`the patient and thereafter implanting the article of autologous
`bone graft to effect fusion. While generally effective, the use
`of autologous bone grafts suffers certain drawbacks. A pri(cid:173)
`mary drawback is the morbidity associated with harvesting
`the autologous graft from the patient's iliac crest. Another
`related drawback is the added surgical time required to per(cid:173)
`form the bone-harvesting.
`Allograft bone grafts have been employed with increased
`regularity in an effort to overcome the drawbacks of autolo(cid:173)
`gous bone grafts. Allograft bone grafts are harvested from
`cadaveric specimens, machined, and sterilized for implanta(cid:173)
`tion. While allograft bone grafts eliminate the morbidity asso(cid:173)
`ciated with iliac crest bone harvesting, as well as decrease the
`overall surgical time, they still suffer certain drawbacks. A
`primary drawback is supply constraint, in that the tissue
`banks that process and produce allograft bone implants find it
`difficult to forecast allograft given the inherent challenges in
`forecasting the receipt of cadavers. Another related drawback
`is that it is difficult to manufacture the allograft with consis(cid:173)
`tent shape and strength characteristics given the variation
`from cadaver to cadaver.
`The present invention is directed at overcoming, or at least
`improving upon, the disadvantages of the prior art.
`
`SUMMARY OF THE INVENTION
`
`The present invention overcomes the drawbacks of the
`prior art by providing a spinal fusion system and related
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 24 of 30
`
`
`
`US 8,361,156 B2
`
`3
`lower surfaces or, alternatively, each spike element may com(cid:173)
`prise a shorter element which only extends through a single
`surface (that is, does not extend through the entire height of
`the implant). In any event, when the spike elements are pro(cid:173)
`vided having radiodense characteristics and the implant is
`manufactured from a radio lucent material (such as, by way of
`example only, PEEK and/or PEKK), the spike elements will
`be readily observable under X-ray or fluoroscopy such that a
`surgeon may track the progress of the implant during implan(cid:173)
`tation and/or the placement of the implant after implantation. 10
`The spinal implant of the present invention may be intro(cid:173)
`duced into a spinal target site through the use of any of a
`variety of suitable instruments having the capability to releas(cid:173)
`ably engage the spinal implant. In a preferred embodiment, 15
`the insertion instrument permits quick, direct, accurate place(cid:173)
`ment of the spinal implant of the present invention into the
`intervertebral space. According to one embodiment, the
`insertion instrument includes a threaded engagement element
`dimensioned to threadably engage into a receiving aperture 20
`formed in the spinal fusion implant of the present invention.
`According to another embodiment, the insertion instrument
`includes an elongate fork member and a generally tubular
`lock member.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`4
`FIG. 9 is a perspective exploded view of the insertion
`instrument of FIG. 1, illustrating the component parts of the
`insertion instrument according to one embodiment of the
`present invention;
`FIG. 10 is a perspective view of a spinal fusion system of
`the present invention, including a cervical fusion implant
`releasably coupled to a cervical insertion instrument accord(cid:173)
`ing to one embodiment of the present invention;
`FIG. 11 is a perspective view of the proximal side of the
`cervical fusion implant of FIG. 10, illustrating (among other
`things) fusion apertures extending between top and bottom
`surfaces, a plurality of visualization apertures extending
`through the lateral walls, a plurality of receiving apertures,
`and a variety of anti-migration features according to one
`embodiment of the present invention;
`FIG. 12 is a perspective view of the distal side cervical
`fusion implant of FIG. 10, illustrating (among other things)
`the visualization apertures and anti-migration features;
`FIG.13 is a top view of the cervical fusion implant of FIG.
`10, illustrating (among other things) the fusion apertures and
`anti-migration features according to one embodiment of the
`present invention;
`FIG.14 is a side view of the cervical fusion implant of FIG.
`10, illustrating (among other things) the visualization aper-
`25 tures, the anti-migration features, and one of two receiving
`apertures provided in the proximal end for releasably engag(cid:173)
`ing the cervical insertion instrument of FIG. 10 according to
`one embodiment of the present invention;
`FIG. 15 is a perspective view of the cervical fusion implant
`30 of the present invention just prior to attachment to the cervical
`insertion device according to one embodiment of the present
`invention;
`FIG.16 is a perspective view of the insertion instrument of
`FIG. 10 in a fully assembled form according to one embodi(cid:173)
`ment of the present invention;
`FIG. 17 is a perspective exploded view of the insertion
`instrument of FIG. 10, illustrating the component parts of the
`insertion instrument according to one embodiment of the
`present invention;
`FIGS. 18 and 19 are perspective and side views, respec(cid:173)
`tively, illustrating the "enhanced visualization" feature of the
`present invention as employed within a lumbar fusion implant
`according to one embodiment of the present invention;
`FIGS. 20 and 21 are perspective and side views, respec(cid:173)
`tively, illustrating the "enhanced visualization" feature of the
`present invention as employed within a lumbar fusion implant
`according to one embodiment of the present invention; and
`FIGS. 22 and 23 are perspective and side views, respec(cid:173)
`tively, illustrating the "enhanced visualization" feature of the
`50 present invention as employed within a cervical fusion
`implant according to one embodiment of the present inven(cid:173)
`tion.
`
`35
`
`Many advantages of the present invention will be apparent
`to those skilled in the art with a reading ofthis specification in
`conjunction with the attached drawings, wherein like refer(cid:173)
`ence numerals are applied to like elements and wherein:
`FIG. 1 is a perspective view of a spinal fusion system of the
`present invention, including a lumbar fusion implant releas(cid:173)
`ably coupled to an insertion instrument according to one
`embodiment of the present invention;
`FIG. 2 is a perspective view of the lumbar fusion implant of
`FIG. 1, illustrating (among other things) fusion apertures
`extending between top and bottom surfaces, a plurality of
`visualization apertures extending through the side walls, and 40
`a variety of anti-migration features according to one embodi(cid:173)
`ment of the present invention;
`FIG. 3 is a top view of the lumbar fusion implant of FIG. 1,
`illustrating (among other things) the fusion apertures and the
`anti-migration features according to one embodiment of the 45
`present invention;
`FIG. 4 is a side view of the lumbar fusion implant of FIG.
`1, illustrating (among other things) the visualization aper(cid:173)
`tures, the anti-migration feature, and a receiving aperture for
`releasably engaging the insertion instrument of FIG. 1
`according to one embodiment of the present invention;
`FIG. 5 is an end view of the lumbar fusion implant of FIG.
`1, illustrating (among other things) the receiving aperture
`formed in the proximal end, the anti-migration features, and
`the visualization apertures according to one embodiment of 55
`the present invention;
`FIG. 6 is an enlarged side view of the lumbar fusion
`implant of FIG. 1 releasably coupled to the distal end of the
`insertion instrument of FIG. 1 according to one embodiment 60
`of the present invention;
`FIG. 7 is a perspective view of the insertion instrument of
`FIG. 1 in a fully assembled form according to one embodi(cid:173)
`ment of the present invention;
`FIG. 8 is an enlarged perspective view of the distal region 65
`of the insertion instrument of FIG. 1 according to one
`embodiment of the present invention;
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Illustrative embodiments of the invention are described
`below. In the interest of clarity, not all features of an actual
`implementation are described in this specification. It will of
`course be appreciated that in the development of any such
`actual embodiment, numerous implementation-specific deci(cid:173)
`sions must be made to achieve the developers' specific goals,
`such as compliance with system-related and business-related
`constraints, which will vary from one implementation to
`another. Moreover, it will be appreciated that such a develop(cid:173)
`ment effort might be complex and time-consuming, but
`would nevertheless be a routine undertaking for those of
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1001, p. 25 of 30
`
`
`
`US 8,361,156 B2
`
`5
`ordinary skill in the art having the benefit of this disclosure.
`The system to facilitate bone fusion and related methods
`disclosed herein boasts a variety of inventive features and
`components that warrant patent protection, both individually
`and in combination.
`FIG. 1 illustrates, by way of example only, a spinal fusion
`system 5 for performing spinal