US008361156B2
`
`(12) Ulllted States Patent
`Curran et a].
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,361,156 B2
`Jan. 29, 2013
`
`(54) SYSTEMS AND METHODS FOR SPINAL
`FUSION
`
`3,848,601 A * 11/1974 Ma et al. ................... .. 606/86 A
`3,867,728 A *
`2/1975 Stubstad et al.
`623/17.16
`
`(75) Inventors: Matthew Curran, Carlsbad, CA (US);
`MarkPeters011,Medf0rd, CA(US)
`
`(73) Assignee: NuVasive, Inc., San Diego, CA (US)
`
`( * ) Notice:
`
`
`Subject to any disclaimer, the term of this patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 13/441,092
`
`-
`_
`(22) Wed‘
`
`(65)
`
`Apr‘ 6’ 2012
`_
`_
`_
`Prior Publication Data
`
`US 2012/0209388 A1
`
`Aug. 16, 2012
`
`Related US. Application Data
`
`(63) Continuation of application No. 13/440,062, ?led on
`Apr. 5, 2012, HOW Pat. NO. 8,246,686, which is a
`continuation of application No. 13/079,645, ?led on
`Apr. 4, 2011, HOW Pat. NO. 8,187,334, which is a
`Continuation of application NO~ 11/093s409s ?led on
`Man 29> 2005’ HOW Pat' NO' 7’918>891~
`(60) Provisional application No. 60/ 557,536, ?led on Mar.
`29, 2004_
`
`(51) Int. Cl.
`
`5/1977 Levy . . . . . . . . . . . . . . . . . .
`
`. . . .. 607/51
`
`4,026,304 A *
`*
`
`i
`g?ijznlee et al' """"""" " 607/32
`4,454,374 A *
`6/1984 Pollack ...................... .. 174/683
`4,501,269 A *
`2/1985 Bagby ......................... .. 606/279
`4,545,374 A * l0/l985 Jacobson
`/
`4,646,738 A
`31987 Trott ........................... .. 606170
`
`"""""""""" "
`
`2 i 437813591 A “H988 Allen g
`
`4,834,757 A
`5/1989 Brantigan
`4,877,020 A 10/1989 Vich
`4,878,915 A 11/1989 Brantigan
`4,932,975 A
`6/1990 Main et al.
`4,950,296 A
`8/1990 McIntyre
`4,961,740 A 10/1990 Ray etal.
`4,962,766 A 10/1990 HerZon
`.
`(Continued)
`
`CA
`
`EP
`
`FOREIGN PATENT DOCUMENTS
`2015507
`V1999
`
`_ 5/1990
`369603
`(Con?rmed)
`
`OTHER PUBLICATIONS
`Alleyne et al., “Current and future approaches to lumbar disc surgery:
`A literature review,” Medscape Orthopedics & Sports Medicne, 1,
`EWWW'medSZaPe'ionvMedscape/onhospomMed/l997/V'0l ‘n1 1/
`mos3057], 1997 .
`
`d
`C t'
`( on “me )
`
`(200601)
`A61F 2/44
`(52) US. Cl. ...... .... ...... ... ................................. .. 623/1716
`(58) Field 0f~Class1?cat10n Search
`623/17.11*17.19
`See application ?le for complete search history.
`
`Primary Examiner * Ellen C Hammond
`Assistant Examiner i Stuart S Bray
`(74) Attorney) Agent] or Firm i Fish & Richardson PC
`
`(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
`
`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
`
`
`
` 1
`
`NUVASIVE 1066
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

`

`US 8,361,156 B2
`Page 2
`
`US. PATENT DOCUMENTS
`5,015,247
`5/ 1991 Michelson
`6/1991 Ray et al.
`5,026,373
`5,047,055
`9/1991 Bao et al.
`10/1991 Ray
`5,055,104
`5,062,845
`11/1991 Kuslich et al.
`12/1991 Steffee
`5,071,437
`5,092,572
`3/1992 Litwak et al.
`7/1992 Chopin
`5,133,717
`5,133,755
`7/1992 Brekke
`5,171,278
`12/1992 Pisharodi
`3/ 1993 Brantigan
`5,192,327
`5,217,497
`6/1993 Mehdian
`11/1993 Bagby
`5,263,953
`5,269,785
`12/1993 Bonutti
`2/ 1994 Raymond et al.
`5,284,153
`5,290,494
`3/1994 Coombes et al.
`5,300,076
`4/ 1994 Leriche
`5,304,210
`4/1994 Crook
`5,306,307
`4/1994 Senter et al.
`4/1994 Wagner et al.
`5,306,309
`5,322,505
`6/1994 Krause et al.
`5,334,205
`8/1994 Cain
`8/1994 Rogers
`5,336,223
`5,364,400
`11/1994 Rego, Jr. et al.
`5,395,372
`3/1995 Holt et al.
`5,397,363
`3/1995 Gelbard
`5,397,364
`3/1995 Kozak
`5,405,391
`4/ 1995 Henderson et al.
`5/1995 MetZ-Stavenhagen
`5,413,602
`6/1995 Brantigan
`5,425,772
`5,431,658
`7/ 1995 Moskovich
`5,443,514
`8/1995 Steffee
`5,443,515
`8/1995 Cohen et al.
`5,445,639
`8/1995 Kuslich et al.
`5,454,811
`10/1995 Huebner
`5,458,638
`10/1995 Kuslich et al.
`5,484,403
`1/1996 Yoakum et al.
`5,484,437
`1/1996 Michelson
`5,489,307
`2/1996 Kuslich et al.
`5,489,308
`2/1996 Kuslich et al.
`5,514,180
`5/1996 Heggeness et al.
`6/1996 Scopelianos
`5,522,879
`5,522,899
`6/ 1996 Michelson
`5,524,624
`6/1996 Tepper et al.
`6/1996 Ray
`5,527,312
`5,534,030
`7/ 1996 Navarro et al.
`5,540,688
`7/1996 Navas
`5,545,222
`8/1996 Bonutti
`5,562,736
`10/1996 Ray et al.
`5,565,005
`10/1996 Erickson et al.
`5,571,190
`11/1996 Ulrich et al.
`5,571,192
`11/1996 Schonhoffer
`5,593,409
`1/1997 Michelson
`3/ 1997 Tropiano
`5,607,424
`5,609,636
`3/1997 Kohrs et al.
`5,611,800
`3/1997 Davis et al.
`5,611,810
`3/1997 Arnold et al.
`5,632,747
`5/1997 Scarborough et al.
`5,645,596
`7/1997 Kim et al.
`5,645,598
`7/1997 Brosnahan et al.
`5,653,761
`8/1997 Pisharodi
`5,653,762
`8/1997 Pisharodi
`5,658,336
`8/1997 Pisharodi
`5,658,337
`8/1997 Kohrs et al.
`5,662,710
`9/1997 Bonutti
`5,665,122
`9/1997 Kambin
`5,669,909
`9/1997 Zdeblick et al.
`5,676,703
`10/1997 Gelbard
`5,683,394
`11/1997 Rinner
`5,683,400
`11/1997 McGuire
`5,683,464
`11/1997 Wagner et al.
`5,690,629
`11/1997 Asher et al.
`5,700,264
`12/1997 Zucherman et al.
`5,700,291
`12/1997 Kuslich et al.
`12/1997 Margulies
`5,700,292
`12/1997 McKay
`5,702,449
`5,702,451
`12/1997 Biedermann et al.
`5,702,453
`12/1997 Rabbe et al.
`
`5,702,454
`5,702,455
`5,703,451
`5,707,373
`5,711,957
`5,716,415
`5,720,748
`5,720,751
`5,728,159
`5,741,253
`5,741,261
`5,755,797
`5,766,252
`5,772,661
`5,775,331
`5,775,797
`5,779,642
`5,782,830
`5,782,919
`5,785,710
`5,797,909
`5,800,549
`5,800,550
`5,814,084
`5,851,208
`5,860,973
`5,865,845
`5,865,848
`5,885,299
`5,888,219
`5,888,224
`5,893,890
`5,904,719
`5,910,315
`5,942,698
`5,954,769
`5,968,098
`5,993,474
`6,003,426
`6,004,326
`6,008,433
`6,015,436
`6,033,405
`6,039,761
`6,042,582
`6,045,580
`6,048,342
`6,059,829
`6,063,088
`6,083,225
`6,096,080
`6,102,948
`6,120,503
`6,120,506
`6,132,472
`6,143,033
`6,159,211
`6,159,215
`6,193,756
`6,200,347
`6,224,607
`6,224,631
`6,241,769
`6,241,771
`6,251,140
`6,258,125
`6,277,149
`6,304,487
`6,319,257
`6,371,989
`6,383,221
`6,409,766
`6,425,772
`6,432,140
`6,440,142
`6,442,814
`6,447,547
`6,454,806
`6,468,311
`
`12/1997
`12/1997
`12/1997
`1/1998
`1/1998
`2/1998
`2/1998
`2/1998
`3/1998
`4/1998
`4/1998
`5/1998
`6/1998
`6/1998
`7/1998
`7/1998
`7/1998
`7/1998
`7/1998
`7/1998
`8/1998
`9/1998
`9/1998
`9/1998
`12/1998
`1/1999
`2/1999
`2/1999
`3/1999
`3/1999
`3/1999
`4/1999
`5/1999
`6/1999
`8/1999
`9/1999
`10/1999
`11/1999
`12/1999
`12/1999
`12/1999
`1/2000
`3/2000
`3/2000
`3/2000
`4/2000
`4/2000
`5/2000
`5/2000
`7/2000
`8/2000
`8/2000
`9/2000
`9/2000
`10/2000
`11/2000
`12/2000
`12/2000
`2/2001
`3/2001
`5/2001
`5/2001
`6/2001
`6/2001
`6/2001
`7/2001
`8/2001
`10/2001
`11/2001
`4/2002
`5/2002
`6/2002
`7/2002
`8/2002
`8/2002
`9/2002
`9/2002
`9/2002
`10/2002
`
`Baumgartner
`Saggar
`Yamamichi
`Sevrain et al.
`Patat et al.
`Steffee
`Kuslich et al.
`Jackson
`Stroever et al.
`Michelson
`MoskovitZ et al.
`Baumgartner
`Henry et al.
`Michelson
`Raymond et al.
`Henstra
`Nightengale
`Farris
`Zdeblick et al.
`Michelson
`Michelson
`Bao et al.
`Sertich
`Grivas et al.
`Trott
`Michelson
`Thalgott
`Baker
`Winslow et al.
`Bonutti
`Beckers et al.
`Pisharodi
`Errico et al.
`Stevenson et al.
`Stevens
`Rosenlicht
`Winslow
`Ouchi
`Kobayashi et al.
`Castro et al.
`Stone
`Schonhoffer
`Winslow et al.
`Li et al.
`Ray
`Scarborough et al.
`Zucherman et al.
`Schlapfer et al.
`Winslow
`Winslow et al.
`Nicholson et al.
`Brosnahan, III
`Michelson
`Kohrs et al.
`Bonutti
`Paul et al.
`Boriani et al.
`Urbahns et al.
`Studer et al.
`Anderson et al.
`Michelson
`Kohrs
`Nicholson et al.
`Gresser et al.
`Marino et al.
`Paul et al.
`Boyle et al.
`Pawletko et al. ...... .. 365/185.22
`Carignan et al.
`Chauvin et al.
`Scarborough et al.
`Brett
`Bernier et al.
`Lin
`Ralph et al.
`Landry et al.
`Michelson
`Cohen et al.
`Boyd et al.
`
`
`
` 2
`
`
`
`

`

`US 8,361,156 B2
`Page 3
`
`12/2002 Ferree
`6,491,724 B1
`3/2003 Lin et al.
`6,527,773 B1
`4/2003 Anderson
`D472,634 S
`4/2003 Anderson
`D473,650 S
`4/2003 Scarborough et al.
`6,547,823 B2
`7/2003 Johnson et al.
`6,595,998 B2
`9/2003 Schmiel et al.
`6,626,905 B1
`6,635,086 B2 10/2003 Lin
`6,648,895 B2 11/2003 Burkus et al.
`6,672,019 B1
`1/2004 Wenz
`6,676,703 B2
`1/2004 Biscup
`6,706,067 B2
`3/2004 Shimp et al.
`6,743,255 B2
`6/2004 Ferree
`11538:? al‘
`7/2004 Shepard
`6,761,739 B2
`6,824,564 B2 11/2004 Crozet
`D503,801 S
`4/2005 Jackson
`6,923,814 B1
`8/ 2005 Hildebrand et al.
`6,942,698 B1
`9/2005 Jackson
`6,964,687 B1
`11/2005 Bernard et a1~
`6979353 B2 12/2005 Breslna
`6,984,245 B2
`1/2006 McGahan et al.
`6’986’788 B2
`V2006 Pa?“ et a1‘
`6,989,031 B2
`1/2006 Michelson
`7,018,416 B2
`300% Hanson et a1‘
`D530,423 s
`10/2006 Miles et al.
`8 021 430 B2
`9 Q0 1 l Michelson
`832463686 B1 *
`8/2012 Curran et a1‘ ,,,,,,,,,, H 623/1716
`2002/0058950 A1
`5/2002 Winterbottom et al.
`2003/ 0105528 A1
`6/ 2003 Shimp et al.
`2003/ 01398 12 A1
`7/ 2003 Garcia et al.
`2004/0153155 A1
`8/2004 Chung et al.
`2005/0197702 A1
`9/2005 COPPGS et 81.
`2007/0191945 A1
`55/2007 Yu et 31~
`Zoos/0015701 A1 *
`1/ 2008 G_ar_Cia et a1~ ~~~~~~~~~~~~~ ~~ 623/1716
`2012/0078374 A1* 3/2012 Vllllers et a1~ ~~~~~~~~~~~ ~~ 623/1716
`
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`W0
`WO
`W0
`WO
`WO
`$8
`WO
`WO
`WO
`WO
`WO
`WO
`
`FOREIGN PATENT DOCUMENTS
`517030
`5/1992
`667127
`8/1995
`706876
`4/1996
`716840
`6/1996
`737448
`“V1996
`796593
`9/l997
`880938
`2/l998
`809974
`4/1998
`809975
`4/199g
`811356
`4/1998
`90/ 00037
`1/ 1990
`91/06261
`5/1991
`92/ 14423
`9/1992
`93/01771
`2/1993
`94/0410‘)
`“994
`
`95/08306
`
`3/l995
`
`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 et al., “Undercutting decompression and posterior fusion vvith
`translaminar facet screw ?xation in degenerative lumbar spinal
`stenosis: Technique andresults,”Neuro-Orthopedics, 17/18, 159-172
`(1995).
`Kambin et al., “History and current status of percutaneous
`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)‘
`Vamvanij et al., “Surgical treatment of internal disc disruption: An
`d ff
`fu .
`t h .
`,, J
`1 fs . ID. _
`outcome stu y 0 our sion ec niques, ourna 0 plna lsor
`d6”, “(3375-382 (1998)
`Baulot et al., “Complementary anterior spondylodesis by
`thoracoscopy. Technical note regarding an observation,” Lyon Surg.,
`90(5)r347-35l (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
`pincott Company (1982).
`Edeland, “Some additional suggestions for an intervertebral disc
`prosthesis,” Journal ofBiomedical Engineering, 7:57-62 (1985).
`Kemp, “Anterior fusion of the spine for infective lesions in adults,”
`Journal ofBone & Joint Surgery, 55B(4):715-734 (1973).
`N V -
`I
`C
`td F- 31 I
`al-d- C
`-
`R d
`u asive, nc.,
`orrec e
`in
`nv i ity ontentions egar Iing
`US 5,860,973, US 6,592,586 and US 6,945,933 ?led in the United
`States District Court, Southern District ofCalifornia on Jun. 14, 2010
`(and 23 aP99995998)
`CoRoentTM Marketing Brochure (9004001 A.0), NuVasive, [nc.,
`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 B.0),
`NuVasive, Inc., 2006, 2 pages.
`CoRoent® XL & XLR Marketing Brochure (9004225 C.0),
`NuVaslve, Inc.,
`2-pages.
`I
`CoRoent® XL Marketing Brochure (9500039 A.0), NuVaslve, Inc.,
`2006, 8 Pages
`
`* cited by examiner
`
`
`
` 3
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jan. 29, 2013
`Jan. 29, 2013
`
`Sheet 1 0f 20
`Sheet 1 of 20
`
`US 8,361,156 B2
`US 8,361,156 B2
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`
`
`FIG. 1
`FIG. 1
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`
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`

`

`US. Patent
`US. Patent
`
`Jan. 29, 2013
`Jan. 29, 2013
`
`Sheet 2 0f 20
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`US 8,361,156 B2
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`Jan.29,2013
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`Jan. 29, 2013
`Jan. 29, 2013
`
`Sheet 4 0f 20
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`US 8,361,156 B2
`US 8,361,156 B2
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`US. Patent
`US. Patent
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`Jan. 29, 2013
`Jan. 29, 2013
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`US 8,361,156 B2
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`Jan. 29, 2013
`Jan. 29, 2013
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`Sheet 7 of 20
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`US 8,361,156 B2
`US 8,361,156 B2
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`US. Patent
`US. Patent
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`Jan. 29, 2013
`Jan. 29, 2013
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`US 8,361,156 B2
`
`1
`SYSTEMS AND METHODS FOR SPINAL
`FUSION
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This application is continuation of US. patent application
`Ser. No. 13/440,062 filed Apr. 5, 2012, which is a continua-
`tion of US. patent application Ser. No. 13/079,645 filed Apr.
`4, 201 1, which is continuation of US. patent application Ser.
`No. 11/093,409 filed Mar. 29, 2005 (now US. 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
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`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 honey 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
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`US 8,361,156 B2
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`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;
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`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
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`US 8,361,156 B2
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`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 int