(12) Ulllted States Patent
`Curran et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,361,156 B2
`Jan. 29, 2013
`
`lJS00836ll56B2
`
`................... .. 606/86A
`3,848,601 A * 11/1974 Ma etal.
`3,867,728 A *
`2/1975 Stubstad et al.
`623/17.16
`4,026,304 A *
`5/1977 Levy . . . . . . . . . . . . . . . . . .
`. . . .. 607/51
`4,026,305 A *
`5/1977 B
`l
`t
`l.
`............. .. 607/32
`4,349,921 A
`9/1982 Kfiilvtvzn eee a
`4,454,374 A *
`5/1934 pouack ,,,,,,,,,,,,,,,,,,,,,, H 174/53,3
`4,501,269 A *
`2/1985 Bagby ......................... .. 606/279
`2 *
`¥;:<:tbS0I1
`606/170
`5
`5
`*
`"""""""""" W523/17.11
`4/1937
`4’657’550 A
`.
`2‘jZ§ij§S? 2 * 131333 §{i‘§fi‘g““ ““““““““““ “ 128/898
`4,834,757 A
`5/1989 Brantigan
`4,877,020 A
`10/1989 Vich
`:2
`113/Iféntigalll
`,
`,
`ain et a .
`2"32?’%38 2
`13/338 1455175?
`4,962,766 A
`10/1990 H
`. erzon
`(Continued)
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`CA
`EP
`
`2015507
`369603
`
`1/1999
`. 5/1990
`(Contlnued)
`
`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/OithoSpoitsMed/1997/v.01.n11/...
`/mos3057], (1997).
`
`d
`'
`C
`( Ommue )
`Primary Examiner — Ellen C Hammond
`Assistant Examiner _ Smart S Bray
`(74) Attorney] Agent] or Firm i Fish & Richardson PC.
`
`(57)
`
`ABSTRACT
`
`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
`
`(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
`USC. 15403) by 0 days
`
`(21) Appl. No.: 13/441,092
`<22)
`Fi1ed=
`Aw W12
`(65)
`Prior Publication Data
`US 2012/0209388 A1
`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, HOW Pat. No. 8,187,334, which is a
`Continuation of application N0~ 11/0935409: 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.
`(200601)
`A61F 2/44
`(52) U..S. Cl.
`...... .... ...... .................................... .. 623/17.16
`(58) Field of ‘Classification Search
`623/1.7.1 1—l7.19
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,486,505 A * 12/1969 Morrison ...................... .. 606/90
`3,518,993 A *
`7/1970 Blake .......................... .. 606/142
`3,604,487 A
`9/1971 Gilbert
`3,745,995 A *
`7/1973 Kraus ............................. .. 602/2
`
`
`
`MSD lll5
`
`

`
`U.S. PATENT DOCUMENTS
`5,015,247 A
`5/1991 Michelson
`550255373 A
`571991 R5Y515i~
`5,047,055 A
`91991 Baoeta.
`5,055,104 4
`10/1991 Ray
`5,062,845 A
`11/1991 Kuslich etal.
`550715437 A
`12/1991 5151155
`550925572 A
`3/ 1992 L11W51‘ 5151
`551335717 A
`7/ 1992 511515111
`551335755 A
`7/ 1992 13151115
`5,171,278 A
`12/1992 Pisharocli
`5,192,327 A
`3/1993 Brantigan
`552175497 A
`5/ 1993 M511511511
`552535953 A
`11/ 1993 135g15Y
`552595755 A
`12/ 1993 1351111111
`5,284,153 A
`2/1994 Raymondetal.
`5,290,494 A
`3/1994 Coombes etal.
`553005075 A
`471994 15115115
`5,304,210 A
`4/1994 Crook
`555065507 4
`4/1994 Senterem
`5,306,309 A
`4/1994 Wagneretal.
`5,322,505 A
`6/1994 Krauseetal.
`553345205 A
`5/ 1994 C5111
`553355223 A
`5/ 1994 R513515
`553545400 A
`11/ 1994 R5g5511~5151~
`5,395,372 A
`3/1995 Holtetal.
`5,397,363 A
`3/1995 Gelbarcl
`553975354 A
`3/ 1995 K5551‘
`5,405,391 A
`4/1995 Hendersonet al.
`5,413,602 A
`5/1995 Metz-Stavenhagen
`554255772 A
`5/ 1995 1315111113511
`554315555 A
`7/ 1995 M551‘5V1511
`554435514 A
`5/ 1995 5151155
`5,443,515 A
`8/1995 Cohenetal.
`554455539 A
`5/ 1995 K11511511 51515
`554545511 A
`10/ 1995 11115151151
`5,458,638 A
`10/1995 Kuslichetal.
`554545403 A
`1/1995 Y5515111151515
`554545437 A
`1/1995 M1511515511
`5,489,307 A
`2/1996 Kuslich etal.
`554595305 A
`2/ 1995 K1151151151515
`5,514,180 A
`5/1996 Heggeness et al.
`5,522,879 A
`6/1996 Scopelianos
`5,522,899 A
`6/1996 Michelson
`555245524 A
`5/ 1995 1515155151515
`555275312 A
`5/ 1995 R5Y
`555345030 A
`7/ 1995 N5V5115 5151
`555405555 A
`7/ 1995 N5V55
`555455222 A
`5/ 1995 1351111111
`555525735 A
`10/ 1995 R5Y 5151
`5,565,005 A
`10/1996 Erickson et al.
`5,571,190 A
`11/1996 Ulrichetal.
`5,571,192 A
`11/1996 Schonhoffer
`5,593,409 A
`1/1997 Michelson
`555075424 A
`3/ 1997 1151515115
`555095535 A
`3/ 1997 K511155151
`555115500 A
`3/ 1997 D5V1551515
`555115510 A
`3/1997 A111515151515
`555325747 A
`5/ 1997 55511551511g115151~
`555455595 A
`7/ 1997 K111151515
`5,645,598 A
`7/1997 Brosnahan et al.
`555535751 A
`5/ 1997 P1511515511
`555535752 A
`5/ 1997 P1511515511
`555555335 A
`5/ 1997 51511515511
`555555337 A
`5/1997 K511155151
`555525710 A
`9/ 1997 1351111111
`555555122 A
`9/ 1997 K511115111
`5,669,909 A
`9/1997 Zdeblicketal.
`555755703 A
`10/ 1997 5151155151
`559535394 A
`11/1997 Rmner
`5,683,400 A
`11/1997 McGuire
`5,683,464 A
`11/1997 Wagner et al.
`A
`Asher etals
`5,700,264 A
`12/1997 zucherrnan etal.
`5,700,291 A
`12/1997 Kuslich etal.
`5,700,292 A
`12/1997 Margulies
`5,702,449 A
`12/1997 McKay
`5,702,451 A
`12/1997 Biedermann etal.
`5,702,453 A
`12/1997 Rabbe etal.
`
`US 8,361,156 B2
`Page2
`
`5,702,454 A
`557g§5:1,5i A
`5,707,373 A
`5
`5
`5,716,315:
`557205748 A
`5,720,751 A
`5,728,159 A
`5,741,253 A
`5,741,261 A
`557555797 A
`557665252 A
`5,772,661 A
`5,775,331 A
`5,775,797 A
`5-’779’642 A
`5-’782’830 A
`5,782,919 A
`5
`5
`5,797,909:
`5-’800’549 A
`5-’800’5-50 A
`5,814,084 A
`5,851,208 A
`5,860,973 A
`558655845 A
`55865848 A
`5,885,299 A
`’
`’
`A
`5,893,890 A
`5,904,719 A
`5,910,315 A
`59425698 A
`5,954,769 A
`5,968,098 A
`59935474 A
`6,003,426 A
`6,004,326 A
`650085433 A
`6,015,436 A
`6’033’405 A
`6’039’761 A
`65042582 A
`6,045,580 A
`6,048,342 A
`6,059,829 A
`6,063,088 A
`6,083,225 A
`6,096,080 A
`6’102’948 A
`65120503 A
`65120506 A
`651325472 A
`6,143,033 A
`6,159,211 A
`6,159,215 A
`6,193,756 B1
`6,200,347 B1
`6,224,607 B1
`6’224’631 B1
`6,241,769 B1
`6,241,771 B1
`6,251,140 B1
`6,258,125 B1
`6,277,149 B1
`6,304,487 131*
`653195257 B1
`6,371,989 B1
`6,383,221 B1
`5
`5
`554095755 131
`
`6,432,140 B1
`6,440,142 B1
`6,442,814 B1
`6,447,547 B1
`6,454,806 B1
`6,468,311 B2
`
`'
`
`,
`
`,
`
`'
`
`,
`
`,
`
`'
`
`,
`
`'
`
`,
`
`,
`
`,
`
`,
`
`,
`
`12/1997 Baumgartner
`37337 iifilggrmehi
`1/1998 Sevrain etal
`1/1333 1s,?§?§eZ”1'
`2/1998 Kusheh etel
`,
`2/1998 Jackson
`3/1998 Stroeveretal
`,
`4/1998 Michelson
`4/1998 Moskovitz etal
`5/1998 Beumgemler
`6/1998 Hemyet 31
`6/1998 Michelson,
`7/1998 Raymondetal
`7/1998 Henstra
`7/1998 Nightengale
`7/1998 Farris
`7/1998 Zdeblick etal
`.
`31333 $233533
`9/1998 B30 etal
`9/1998 Selfieh ,
`9/1998 Grivasetal
`12/1998 Trott
`1/1999 Michelson
`2/1999 Thelgefi
`2/1999 Baker
`3/1999 Winslow etal
`-
`37333
`etel
`4/1999 Pisharodi
`5/1999 Errico etal
`6/1999 Stevenson etal
`8/1999 Stevens
`9/1999 Rosenlicht
`10/1999 Winslow
`“/1999 Ouehi
`12/1999 Kobayashietal
`12/1999 Castro etal
`'
`12/1999 Stone
`1/2000 Schonhoffer
`3/2000 Winslow etal
`3/2000 Lietal
`'
`3/2000 Rey
`4/2000 Scarborough etal
`4/2000 zucherrnan etal
`5/2000 Schlapferetal
`5/2000 Winslow
`7/2000 Winslow etal
`8/2000 Nicholson etz11
`8/2000 Brosnahan HI,
`9/2000 Michelson’
`9/2000 Kehrset 31
`10/2000 Benum '
`11/2000 Paul et al
`12/2000 Borianieial
`12/2000 Urbahnseta,1
`,
`2/2001 Studeretal
`3/2001 Anderson e,ta1
`5/2001 Michelson
`5/2001 Kohrs
`6/2001 Nicholson etal
`6/2001 Gresseretal
`6/2001 Marino etal,
`7/2001 Paul etal
`,
`8/2001 Boyle etal
`10/2001 PaW1etkoe,ta1
`“/2001 Cmenen em‘ """ "
`4/2002 Chauvin etal,
`5/2002 s
`b
`,ta1
`551 5151113115
`5/2002 131511.
`B_ern1ereta1.
`8/2002 Lin
`8/2002 Ralph et 511.
`9/2002 Landlv etal.
`9/2002 Michelson
`9/2002 Cohen etal.
`10/2002 Boydetal.
`
`,
`
`5
`
`365/185 22
`'
`
`

`
`US 8,361,156 B2
`Page 3
`
`6,491,724 B1
`6,527,773 B1
`D472,634 S
`D473,650 S
`6,547,823 B2
`6,595,998 B2
`6,626,905 B1
`6,635,086 B2
`6,648,895 B2
`6,672,019 B1
`6,676,703 B2
`6,706,067 B2
`6,743,255 B2
`6,746,484 B1
`6,755,841 B2
`6,761,739 B2
`5,324,554 B2
`D503,801 S
`6,923,814 B1
`6,942,698 B1
`5,954,587 B1
`6979353 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 B1 *
`2002/0058950 A1
`2003/0105528 A1
`2003/0139812 A1
`2004/0153155 A1
`2005/0197702 A1
`2007/0191945 A1
`2008/0015701 A1 *
`2012/0078374 A1*
`
`12/2002 Ferree
`3/2003 Lin et a1.
`4/2003 Anderson
`4/2003 Anderson
`4/2003 Scarborough et al.
`7/2003 Johnson et a1.
`9/2003 Schmiel et a1.
`10/2003 Lin
`11/2003 Burkus et a1.
`1/2004 Wenz
`1/2004 Biscup
`3/2004 Shimp et al.
`6/2004 Ferree
`6/2004 Liu et a1.
`6/2004 Fraser et 31'
`7/2004 Shepard
`11/2004 Crozet
`4/2005 Jackson
`8/2005 Hildebrand et al.
`9/2005 Jackson
`11/2005 Bernard Gt €11~
`12/2005 Bresina
`1/2006 McGahan et a1.
`1/2006 Paul et a1.
`1/2006 Michelson
`3/2006 Hanson et al.
`10/2006 Miles et al.
`9/2011 Michelson
`............ .. 623/ 17. 16
`8/2012 Curran et al.
`5/2002 Winterbottom et al.
`6/2003 Shimp et al.
`7/2003 Garcia et al.
`8/2004 Chung et a1.
`9/2005 COPPGS Gt 31.
`8/2007 Y11 et 31~
`1/2008 Garcia et al.
`3/2012 Villiers et al.
`
`............. .. 623/17.16
`........... .. 623/17.16
`
`EP
`EP
`3
`EP
`Er,
`Er,
`EP
`Ep
`EP
`WO
`WO
`W0
`W0
`$8
`WO
`WO
`W0
`WO
`WO
`WO
`
`WO
`
`FOREIGN PATENT DOCUMENTS
`517030
`5/1992
`667127
`8;1995
`£2323
`‘£7332
`737448
`10/1996
`796593
`9/1997
`880938
`2/1998
`809974
`4/1998
`309975
`4/1993
`811356
`4/1998
`90/00037
`1/1990
`91/06261
`5/1991
`92/ 14423
`9/1992
`93/01771
`2/1993
`gjfigégg
`Z33:
`95701810
`1/1995
`95/08306
`3/1995
`
`96/17564
`96/41582
`97/20513
`
`97/33525
`
`3/1996
`12/1996
`6/1997
`
`9/1997
`
`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
`01/41681
`01/49333
`
`10/1997
`3/1998
`4/1998
`4/1998
`6/1998
`2/1999
`8/1999
`8/2000
`8/2000
`6/2001
`7/2001
`
`OTHER PUBLICATIONS
`.
`.
`.
`.
`.
`“
`.
`.
`Benini eta1., Undercutting decompression and posterior fusion V-Vltll
`translaminar facet screw fixation in degenerative lumbar spinal
`stenosis: Technique andresults,”Neuro—0rthopedics, 17/18, 159-172
`(1995).
`status of percutaneous
`Kambin et al., “History and current
`arthroscopic disc surgery,” Spine, 21(24S):57S-61S (1996).
`Stein et al., “Percutaneous facet joint fusion: Preliminary experi-
`ence,” Journal of Vascular and Interventional Radiology, 4:69-74
`(1993).
`--
`..
`-
`-
`-
`-
`-
`,
`Vatmvanij eltldal, fSfurgi1elz11l_treattm1e1:n_t of inte/rnal ClllSC dLi§sr_uptli(g1_. An
`ou come s
`y o
`our
`sion ec niques,
`ourna of pina
`isor—
`4*“ “(5)3375'38f (1998)
`_
`_
`Baulot
`et
`al.,
`Complementary. anterior
`spondylodesis by
`thoracoscopy. Techmcal note regarding an observatlon,” Lyon Surge
`90(5)r347-351 (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 Irrterbody Fusrorr,” C[,'m'ea[ Orthopaedics
`& Related Research, Marshau R. Urist, Edit0r_ir1_(;hief, J. 13. Lip.
`pincott Company (1982).
`Edeland, “Some additional suggestions for an interveitebral disc
`prosthesis,” Journal 0fBi0medical Engineering, 7:57-62 (1985).
`Kemp, “Anterior fusion of the spine for infective lesions in adults,”
`11/\'I0u\r/na-l 0fBone & Joint Surgery, 55B(_4)_:715-734 (1973).
`_
`u asive, 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 ofCalifornia on Jun. 14, 2010
`(and 23 appendices).
`CoRoentTM Marketing Brochure (9004001 A.0), NuVasive, Inc.,
`2004, 2 pages.
`CoRoentTM Marketing Brochure (9004001 C.0), NuVasive, Inc.,
`2005, 2 pages.
`CoRoentTM XL & XLR Marketing Brochure (9004225 A.0),
`NuVasive, Inc., 2005, 2 pages.
`CoRoent® XL & XLR Marketing Brochure (9004225 130),
`NuVasive, Inc., 2006, 2 pages.
`CoRoent® XL & XLR Marketing Brochure (9004225 C.0),
`NuVasive, II’lC.,
`2pages.
`I
`CoRoent® XL Marketing Brochure (9500039 A.0), NuVaszve, Inc.,
`2006, 8 pages.
`
`* cited by examiner
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 1 of 20
`
`US 8,361,156 B2
`
`FIG. 1
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 2 of 20
`
`US 8,361,156 B2
`
`: ‘—n-.-..n.-.-......-.~.n.--'
`i‘;
`
`M
`
`l§3°§.{§§«. {Z
`
`
`
`

`
`U S. Patent
`
`Jan. 29, 2013
`
`Sheet 3 of 20
`
`US 8,361,156 B2
`
`
`
`
`
`,,,,,,,::;........H.H.vHH.........5:.,,
`
`
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 4 of 20
`
`US 8,361,156 B2
`
`
`
`§%”§i{L¥.
`
`22$
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 5 of 20
`
`US 8,361,156 B2
`
` 2
`
`X
`
`‘.2’
`
`k./'
`
`./
`
`W“.
`5’
`x,‘
`.,\
`
`k: i.
`
`.1‘
`g
`
`S
`S
`:
`5
`E
`.
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 6 of 20
`
`US 8,361,156 B2
`
` é
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 7 of 20
`
`US 8,361,156 B2
`
`FIG. 7
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 8 of 20
`
`US 8,361,156 B2
`
`
`
`.4,
`
`g
`
`‘,-
`
`§3.¥.{§i. 3
`
`T
`
`%W&
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 9 of 20
`
`US 8,361,156 B2
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 10 of 20
`
`US 8,361,156 B2
`
`FIG. 10
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 11 of 20
`
`US 8,361,156 B2
`
`..............x...........“..\..
`
`......<v.
`
`-2»
`-1-.» ."§§;.‘”‘
`
`,-.~.
`WmH.“
`"-wgzv-.1.-,
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 12 of 20
`
`US 8,361,156 B2
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 13 of 20
`
`US 8,361,156 B2
`
`W
`
`.,....
`
`.\...K.\........................r.:.;...>...a?;.....x.u.“.“
`
`.....{.......w......
`
`.h......
`
`WM.
`
`
`
`xfuvlxx.
`
`
`
`....x...5.................................&..........
`
`
`
`
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 14 of 20
`
`US 8,361,156 B2
`
`~ ~ -.~.-.~.-.~.-.~.-.-.-.-,~.~.-.-.-.-.-.-.-.
`
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 15 of 20
`
`US 8,361,156 B2
`
`12
`
`15
`
`17
`
`21
`
`FIG. 15
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 16 of 20
`
`US 8,361,156 B2
`
`FIG.16
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 17 of 20
`
`US 8,361,156 B2
`
`jL§??§i{I§§-..
`
`'3 ‘Z?
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 18 of 20
`
`US 8,361,156 B2
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 19 of 20
`
`US 8,361,156 B2
`
`

`
`U.S. Patent
`
`Jan. 29, 2013
`
`Sheet 20 of 20
`
`US 8,361,156 B2
`
`

`
`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-
`tion of U.S. patent application Ser. No. 13/079,645 filed Apr.
`4, 201 1, 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 ofthe 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
`
`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-
`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 PriorArt
`Currently there are nearly 500,000 spine lumbar and cer-
`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-
`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-
`nates neural impingement commonly associated with a dam-
`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
`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-
`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-
`form the bone-harvesting.
`Allograft bone grafts have been employed with increased
`regularity in an effort to overcome the drawbacks of autolo-
`gous bone grafts. Allograft bone grafts are harvested from
`cadaveric specimens, machined, and sterilized for implanta-
`tion. While allograft bone grafts eliminate the morbidity asso-
`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-
`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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`
`methods involving the use of a spinal fusion implant of non-
`bone construction. The non-bone construction of the spinal
`fusion implant of the present invention overcomes the draw-
`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-
`tions (e. g. poly-ether-ether-ketone (PEEK) and/or poly-ether-
`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-
`ing upon the particular surgical procedure or need. The spinal
`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-
`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-
`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
`length about 14 mm.
`The spinal fusion implant of the present invention may be
`provided with any number of additional features for promot-
`ing fusion, such as apertures extending between the upper and
`lower vertebral bodies which allow a boney bridge to form
`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-
`ing but not limited to bone morphogenic protein (BMP) and
`bio-resorbable polymers, including but not limited to any of a
`variety of poly (D,L-lactide-co-glycolide) based polymers.
`The spinal fusion implant of the present invention is prefer-
`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-
`tion features may include, but are not necessarily limited to,
`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-
`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-
`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-
`rials, including but not limited to a metal, ceramic, and/or
`polymer material, preferably having radiopaque characteris-
`tics. The spike elements may also take any of a variety of
`suitable shapes, including but not limited to a generally elon-
`gated element disposed within the implant such that the ends
`thereof extend generally perpendicularly from the upper and/
`or lower surfaces ofthe implant. The spike elements may each
`comprise a unitary element extending through upper and
`
`

`
`US 8,361,156 B2
`
`3
`lower surfaces or, alternatively, each spike element may com-
`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-
`vided having radiodense characteristics and the implant is
`manufactured from a radiolucent 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 ofthe implant during implan-
`tation and/or the placement of the implant after implantation.
`The spinal implant of the present invention may be intro-
`duced into a spinal target site through the use of any of a
`variety of suitable instruments having the capability to releas-
`ably engage the spinal implant. In a preferred embodiment,
`the insertion instrument permits quick, direct, accurate place-
`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
`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
`
`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-
`ence numerals are applied to like elements and wherein:
`FIG. 1 is a perspective view of a spinal fusion system ofthe
`present invention, including a lumbar fusion implant releas-
`ably coupled to an insertion instrument according to one
`embodiment of the present invention;
`FIG. 2 is a perspective view ofthe 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
`a variety of anti-migration features according to one embodi-
`ment of the present invention;
`FIG. 3 is a top view ofthe lumbar fusion implant ofFIG. 1,
`illustrating (among other things) the fusion apertures and the
`anti-migration features according to one embodiment of the
`present invention;
`FIG. 4 is a side view of the lumbar fusion implant of FIG.
`1, illustrating (among other things) the visualization aper-
`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
`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
`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-
`ment of the present invention;
`FIG. 8 is an enlarged perspective view of the distal region
`of the insertion instrument of FIG. 1 according to one
`embodiment of the present invention;
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`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-
`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 ofthe 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 ofthe cervical fusion implant of FIG.
`10, illustrating (among other things) the visualization aper-
`tures, the anti-migration features, and one of two receiving
`apertures provided in the proximal end for releasably engag-
`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
`ofthe present inventionjust 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-
`ment of the present invention;
`FIG. 17 is a perspective exploded view of the insertion
`instrument of FIG. 10, illustrating the component parts ofthe
`insertion instrument according to one embodiment of the
`present invention;
`FIGS. 18 and 19 are perspective and side views, respec-
`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-
`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-
`tively, illustrating the “enhanced visualization” feature of the
`present
`invention as employed within a cervical fusion
`implant according to one embodiment of the present inven-
`tion.
`
`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-
`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-
`ment effort might be complex and time-consuming, but
`would nevertheless be a routine undertaking for those of
`
`

`
`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 fusion between adjacent lum-
`bar vertebrae, including an exemplary spinal fusion implant
`10 and an exemplary insertion instrument 20 provided in
`accordance with the present invention. The spinal fusion
`implant 10 may be comprised of any suitable non-bone com-
`position having suitable radiolucent characteristics, includ-
`ing but not limited to polymer compositions (e. g. poly-ether-
`ether-ketone
`(PEEK)
`and/or
`poly-ether-ketone-ketone
`(PEKK)) or any combination of PEEK and PEKK. The spinal
`fusion implant 10 of the present invention may be dimen-
`sioned, by way of example only, having a width ranging
`between 9 and 18 mm, a height ranging between 8 and 16 mm,
`and a length ranging between 25 and 45 mm.
`As will be described in detail below, the insertion instru-
`ment 20 is configured to releasably maintain the exemplary
`spinal fusion implant 10 in the proper orientation during
`insertion into a lumbar disc space and thereafter release to
`deposit the implant 10. The exemplary spinal fusion implant
`10, having been deposited in the disc space, facilitates spinal
`fusion over time by maintaining a restored disc height as
`natural bone growth occurs through and/or past the implant
`10, resulting in the formation of a boney bridge extending
`between the adjacent vertebral bodies. The implant 10 is
`particularly suited for introduction into the disc space via a
`lateral (trans-psoas) approach to the spine, but may be intro-
`duced in any of a variety of approaches, such as posterior,
`anterior, antero -lateral, and postero-lateral, without departing
`from the scope of the present invention (depending upon the
`sizing of the implant 10).
`The spinal fusion implant 10 of the present invention may
`be provided with any number of additional features for pro-
`moting fusion, such as apertures 2 extending between the
`upper and lower vertebral bodies which allow a boney bridge
`to form through the spinal fusion implant 10. According to a
`still further aspect ofthe present invention, this fusion may be
`facilitated or augmented by introducing or positioning vari-
`ous osteoinductive materials within the apertures 2 and/or
`adjacent to the spinal fusion implant 10. Such osteoinductive
`materials may be introduced before, during, or after the inser-
`tion of the exemplary spinal fusion implant 10, and may
`include (but are not necessarily limited to) autologous bone
`harvested from the patient receiving the spinal fusion implant
`10, bone allograft, bone xenograft, any number of non-bone
`implants (e.g. ceramic, metallic, polymer), bone morpho-
`genic protein, and bio-resorbable compositions, including but
`not limited to any of a variety of poly (D,L-lactide-co-gly-
`colide) based polymers.
`The spinal fusion implant 10 of the present invention is
`preferably equipped with one or more visualization apertures
`4 situated along the lateral sides, which aid in visualization at
`the time of implantation and at subsequent clinical evalua-
`tions. More specifically, based on the generally radiolucent
`nature ofthe implant 10, the visualization apertures 4 provide
`the ability to visualize the interior of the implant 10 during
`X-ray and/or other suitable imaging techniques which are
`undertaken from the side (or “lateral”) perspective of the
`implant 10. If fusion has taken place, the visualization aper-
`tures 4 will provide a method for the surgeon to make follow
`up assessments as to the degree of fusion without any visual
`interference from the spinal fusion implant 10. Further, the
`visualization apertures 4 will provide an avenue for cellular
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6
`migration to the exterior ofthe spinal fusion implant 10. Thus
`the spinal fusion implant 10 will serve as additional scaffold-
`ing for bone fusion on the exterior ofthe spinal fusion implant
`10.
`
`FIGS. 2-5 depict various embodiments of the exemplary
`spinal fusion implant 10. Some common attributes are shared
`among the various embodiments. More specifically, each spi-
`nal fusion implant 10 has a top surface 31, a bottom surface
`33, lateral sides 14, a proximal side 22, and a distal side 16. In
`one embodiment, the top and bottom surfaces 31, 33 are
`generally parallel. It can be appreciated by one skilled in the
`art that al