US008192356B2
`
`(12) United States Patent
`Miles et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,192,356 B2
`*Jun. 5, 2012
`
`(54)
`
`(75)
`
`SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`Inventors: Patrick Miles, San Diego, CA (US);
`Scot Martinelli, San Diego, CA (US);
`Eric Finley, San Diego, CA (US);
`James Gharib, San Diego, CA (US);
`Allen Farquhar, San Diego, CA (US);
`Norbert Kaula, Arvada, CO (US);
`Jeffrey BleWett, San Diego, CA (US);
`Goretti Medeiros, legal representative,
`Plantsville, CT (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
`USC 154(b) by 370 days.
`This patent is subject to a terminal dis
`claimer.
`
`(21)
`
`(22)
`
`(65)
`
`(63)
`
`(60)
`
`(51)
`
`(52)
`
`Appl. N0.: 12/635,418
`
`Filed:
`
`Dec. 10, 2009
`
`Prior Publication Data
`
`US 2010/0094093 A1
`
`Apr. 15, 2010
`
`Related US. Application Data
`
`Continuation of application No. 12/428,081, ?led on
`Apr. 22, 2009, noW Pat. No. 7,935,051, Which is a
`continuation of application No. 10/608,362, ?led on
`Jun. 26, 2003, noW Pat. No. 7,582,058.
`
`Provisional application No. 60/392,214, ?led on Jun.
`26, 2002.
`
`Int. Cl.
`(2006.01)
`A61B 1/32
`US. Cl. ...................................... .. 600/202; 600/546
`
`(58) Field of Classi?cation Search ................ .. 600/221,
`600/215, 202, 210, 546, 223, 201, 214, 224,
`600/219; 607/131,130,129,117,119,43,
`607/2; 606/90, 324, 99, 129
`See application ?le for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`208,227 A
`9/1878 Dorr
`972,983 A 10/1910 Arthur
`1,328,624 A
`1/1920 Graham
`(Continued)
`
`DE
`
`FOREIGN PATENT DOCUMENTS
`299 08 259
`7/1999
`(Continued)
`OTHER PUBLICATIONS
`
`Bergey et a1, “Endoscopic Lateral Transpsoas Approach to the Lum
`bar Spine,” Spine, 2004, 29(15): 1681-1688.
`(Continued)
`Primary Examiner * Pedro Philogene
`(74) Attorney, Agent, or Firm * Fish & Richardson RC.
`(57)
`ABSTRACT
`A system for accessing a surgical target site and related meth
`ods, involving an initial distraction system for creating an
`initial distraction corridor, and an assembly capable of dis
`tracting from the initial distraction corridor to a secondary
`distraction corridor and thereafter sequentially receiving a
`plurality of retractor blades for retracting from the secondary
`distraction corridor to thereby create an operative corridor to
`the surgical target site, both of Which may be equipped With
`one or more electrodes for use in detecting the existence of
`(and optionally the distance and/or direction to) neural struc
`tures before, during, and after the establishment of an opera
`tive corridor to a surgical target site.
`37 Claims, 33 Drawing Sheets
`
`
`
` 1
`
`NUVASIVE 1070
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

`

`US. PATENT DOCUMENTS
`1548184 A
`8,1925 Cameron
`2,704,064 A
`6/1955 1312261161211.
`217361002 A
`2/1956 Oriel
`2,808,826 A 10/1957 R6111616161.
`81883125? A
`81882 ?le 8131'
`316821162 A
`8,1972
`3,785,368 A
`1/1974 M6(y:61111y6161
`3,830,226 A
`8/1974 $16111) 6161.
`3,957,036 A
`5/1976 N6111161111
`410991519 A
`7/1978 Warren
`38881857‘ A
`288% iiirykdeétaii
`4,224,949 A
`9/1980 s66116161.
`4,226,228 A 10/1980 5111116161.
`4,235,242 A 11/1980 H6w66116161.
`412851347 A
`8/1981 Hess
`4,291,705 A
`9/1981 s6v61111g1161166161.
`4,461,300 A
`7/1984 Christensen
`4,515,168 A
`5/1985 Chesteretal.
`4,519,403 A
`5/1985 Dickhudt
`4,545,374 A 10/1985 JaCObSOIl
`4,561,445 A 12/1985 B611<66161.
`4,562,832 A
`1/1986 W1161616161.
`.
`415731448 A
`3/1986 K111111111
`31238188; A
`88328 gglsletal'
`416111597 A
`9/l986 Kmltga
`4,633,889 A
`1/1987 T616116
`4658 835 A
`4/1987 POhIldOff
`1
`1
`.
`313238;; A
`gygtsm
`4,784,150 A 11/1988 V661111666161.
`418071642 A
`2/ 1989 Brown
`418921105 A
`V1990 Pm“
`31381882 A
`28338 guque
`419621766 A M1990 H2321}
`4,964,411 A 10/1990 16111166116161.
`5,052,373 A 10/1991 M1611616611
`510581602 A 10/1991 Brody.
`2831228 A
`8833; Belem
`511271403 A
`M992 Bfgwnlee
`
`5,007,902 A
`
`4/1991 W111
`
`US 8,192,356 B2
`Page2
`
`1
`
`1
`
`5,566,678 A 10/1996 Cadwell
`5,571,149 A 11/1996 L1666161.
`21252112; A 181888 8881“
`5,599,279 A
`2/1997 s1611116116161
`516301813 A
`5,1997 Kiemmkis '
`5,667,508 A
`9/1997 B11166 6161.
`5,671,752 A
`9/1997 s1116161by6161.
`516811265 A 10/1997 Maed??ta1'
`A
`18882 13311811“
`517281046 A
`M998 Ma t 1
`,
`,
`yere a.
`5,741,253 A
`4/1998 M1611616611
`5,759,159 A
`6/1998 M6616116Z
`21385188? A
`28882 ?anlllblln
`517751331 A
`M998 Ram “(Ant 1
`517761144 A
`M998 L @051 etal'
`5,779,642 A
`7/1998 N(1y1S1l1e611e61Z 3'
`517851658 A
`M998 Be‘iarong
`5’792’044 A
`8/1998 Foleyetal
`5’797’854 A
`8/1998 Hed ecock
`1
`1
`H998 B gm.
`A 18/1998 H03. 1 t 1
`H998 Ga ‘96 a1
`A @1998 Gqzfgrtllll
`,
`,
`11
`et a1.
`5,860,973 A
`1/1999 M1611616611
`5,862,314 A
`1/1999 16616161611
`5,872,314 A
`2/1999 (:11111611
`A
`88888 139x11
`1
`1
`“15 tepgale
`5,888,196 A
`3/1999 B61111111
`5,891,147 A
`4/1999 M661<6v11Z 6161.
`21388188; A
`38888 goley etal'
`010s et 31.
`,
`,
`5,928,158 A
`7/1999 A116116166
`5,935,131 A
`8/1999 B611111116161.
`5,938,688 A
`8/1999 $611111
`5,944,658 A
`8/1999 K61666161.
`218821823 A 38888 gi’tzanletal'
`8188813515 A 58888 112mm“
`oley et a1.
`,
`,
`6,024,696 A
`2/2000 116111116116161.
`6,027,456 A
`2/2000 P61616161.
`6,038,469 A
`3/2000 K611666116161.
`
`1
`
`1
`
`. “1311
`
`5,161,533 A 11/1992 P1666 6161. 511711279 A 12/1992 Mathews
`
`5,195,541 A
`3/1993 Ob€IlCh3iIl .................. .. 128/898
`5196015 A
`3/1993 N6111161611
`R’E34’390 E
`9/l993 Culver
`1
`“993 on
`21555512251; A 18/1994 Kle‘i?nski
`5,284,153 A
`2/1994 R6y111611616161.
`5,284,154 A
`2/1994 Raymondetal.
`5,295,994 A
`3/1994 B61111111
`5,299,563 A
`4/1994 s61611 .......................... .. 600/215
`5312417 A
`5/1994 Wilk
`5’313’956 A
`5/1994 Knutssonetal
`5,313,962 A
`5/1994 ObeIlCh?iIl
`7/1994 L6111111611
`5327 902 A
`.
`1
`1
`A
`8888: ?glfl‘llttrtrllan et 31
`5,342,384 A
`8/1994 $11g61b61<61
`A 18188;‘ guecvlan
`513951317 A
`3,1995 KJHI‘Zma
`5’450’845 A
`9/l995 AXl d
`514741057 A M1995 Maigaxfretal
`
`5375 067 A 12/1994 B61611111
`1
`1
`
`V1996
`5,480,440 A
`V1996 Ruff
`534823038 A
`1/1996 M1611616611
`5,484,437 A
`4/1996 1116666
`5,509,893 A
`5/1996 B61111111
`5,514,153 A
`7/1996 w116611
`5,540,235 A
`8/1996 R6166
`5,549,656 A
`5,560,372 A 10/1996 c61y
`
`38888 6/2000 N611161166116161
`
`81888133; A 6,074,343 A
`
`7,2000 Liuetal
`'
`610831154 A
`1.
`1
`1
`8/2000 Shmu1eW1tZ
`6,095,987 A
`8/2000 A16 6161.
`6,104,957 A
`8/2000 D11y661166161.
`6,104,960 A
`81581288 A 188888 gligctlzlelson
`6’l32’386 A 100000 Gozanietal
`611321387 A 10/2000 G . M11
`611351965 A 10,2000 Tom” 1
`1
`1
`umeretal'
`6,139,493 A 10/2000 Korosfztal. ................. .. 600/215
`81128188? A 185888 198m‘
`‘WY @1311
`1
`1
`6,161,047 A 12/2000 K111g6161.
`6,174,311 B1
`1/2001 B16116116161.
`81188188; 5%
`$88} grass
`31
`1
`1
`ester“ 1
`6,206,826 131
`3/2001 M61116w66161.
`6,217,509 B1
`4/2001 F616y 6161.
`6,224,549 B1
`5/2001 1316111161611
`6,259,945 B1
`7/2001 Epstelnetal.
`6,264,651 B1
`7/2001 U116161w66616161.
`
`6,273,905 B1
`6,292,701 B1
`6,306,100 B1
`6,308,712 B1
`6,312,392 B1
`6,325,764 B1
`6,334,068 B1
`6,348,058 B1
`
`8/2001 Streeter
`9/2001 Prass et a1.
`10/2001 Prass
`10/2001 Shaw
`11/2001 Herzon
`12/2001 (1111111116161.
`12/2001 H661<61
`2/2002 M611<61116161
`
`
`
` 2
`
`
`
`

`

`US 8,192,356 B2
`Page 3
`
`2006/0224078 A1 10/2006 Hoey et al.
`2007/0016097 A1
`1/2007 Farquhar et al.
`2007/0198062 A1
`8/2007 Miles et al.
`2007/0293782 A1 12/2007 Marino
`2008/0058606 A1
`3/2008 Miles et al.
`2008/0064976 A1
`3/2008 Kelleher et al.
`2008/0064977 A1
`3/2008 Kelleher et al.
`2008/0065178 A1
`3/2008 Kelleher et al.
`2008/0071191 A1
`3/2008 Kelleher et al.
`2008/0097164 A1
`4/2008 Miles et al.
`2008/0300465 A1 12/2008 Feigenwinter et al.
`2009/0124860 A1
`5/2009 Miles et al.
`2009/0138050 A1
`5/2009 Ferree
`2009/0192403 A1
`7/2009 Gharib et al.
`2009/0204016 A1
`8/2009 Gharib et al.
`2010/0069783 A1
`3/2010 Miles et al.
`2010/0130827 A1
`5/2010 Pimenta et al.
`2010/0152603 A1
`6/2010 Miles et al.
`2010/0160738 A1
`6/2010 Miles et al.
`2010/0174148 A1
`7/2010 Miles et al.
`
`FOREIGN PATENT DOCUMENTS
`0 972 538
`H2000
`EP
`2 795 624
`H2001
`FR
`WO 00/38574
`'7/2000
`W0
`WO 00/66217
`11/2000
`W0
`WO 00/67645
`II/ZOOO
`W0
`WO 01/37728
`5/2001
`W0
`W0 02/054960
`7/2002
`W0
`W0 03/005887
`H2003
`W0
`W0 03/026482
`4/2003
`W0
`W0 03/037170
`5/2003
`W0
`W0 W0 Zoos/013805
`2/2005
`W0 W0 Zoos/030318
`4/2005
`W0 WO 2006/042241
`4/2006
`W0 WO 2006/066217
`6/2006
`
`OTHER PUBLICATIQNS
`
`3/2002 Gerber et al.
`6,360,750 B1
`7/2002 Foley et al.
`6,425,859 B1
`7/2002 Zhu et al.
`6,425,901 B1
`9/2002 Rioux et al.
`6,450,952 B1
`9/2002 Rittman, III et al.
`6,451,015 B1
`10/2002 Kaula et al.
`6,466,817 B1
`10/2002 Mollenauer et al.
`6,468,205 B1
`10/2002 Fowler, Jr.
`6,468,207 B1
`6,500,128 B2 12/2002 Marino
`6,520,907 B1
`2/2003 Foley et al.
`6,524,320 B2
`2/2003 DiPoto
`6,535,759 B1
`3/2003 Epstein et al.
`6,564,078 B1
`5/2003 Marino et al.
`6,579,244 B2
`6/2003 Goodwin
`6,620,157 B1
`9/2003 Dabney et al.
`6,645,194 B2 11/2003 Briscoe et al.
`6,679,833 B2
`1/2004 Smith et al.
`6,719,692 B2
`4/2004 Kleffner et al.
`6,760,616 B2
`7/2004 Hoey et al.
`6,770,074 B2
`8/2004 Michelson
`6,796,985 B2
`9/2004 Bolger et al.
`6,810,281 B2 10/2004 Brock et al.
`6,819,956 B2 ll/2004 DlLOl‘eIlZO
`6,847,849 B2
`l/2005 M31110 6t
`6,849,047 B2
`2/2005 GOOClWlIl
`6,855,105 B2
`2/2005 Jackson, 111 et al.
`6,871,099 B1
`3/2005 Whitehurst 6t
`6,902,569 B2
`6/2005 Farmer 61 al.
`6,926,728 B2
`8/2005 Zucherman et al.
`6,929,606 B2
`8/2005
`6,945,933 B2 *
`9/2005 Branch et al. ............... .. 600/210
`6,951,538 B2 10/2005 Ritland
`7,047,082 B1
`5/2006 SChI‘OIIl et al.
`7,050,848 B2
`5/2006 Hoey et al.
`7,079,883 B2
`7/2006 Marino 61 al.
`7,089,059 B1
`8/2006 Pless
`7,177,677 B2
`2/2007 Kaula et al.
`7,198,598 B2
`4/2007 Smith et al.
`7,207,949 B2
`4/2007 Miles et al.
`7,226,451 B2
`6/2007 ShluZas et al.
`7,261,688 B2
`8/2007 Smlth et al'
`gelleher et al'
`V2009 Lee et a1‘
`7,481,766 B2
`4/2009 Kaula et a1, ,,,,,,,,,,,,,,,,, ,, 600/546
`7,522,953 B2 *
`7/2009 Branch et al.
`7,556,601 B2
`9/2009 Miles 61 a1,
`7 , 582,0 58 B 1
`1/2010 Pond et al.
`7,643,884 B2
`. 600/219
`4/2010 Miles et al. .
`7,691,057 B2 *
`~ 600/224
`7,819,801 B2 * 10/2010 Miles et 31~ ~
`7,935,051 B2 *
`5/2011 Mlles et a1~ ~~~~~~~~~~~~~~~~~ ~~ 600/202
`2001/0039949 A1 11/2001 Loubser
`2001/0056280 A1 12/2001 Undqwood et a1‘
`2002/0007129 A1
`1/2002 Mar1no
`20020010392 Al
`V2002 Desai
`2002/0072686 A1
`6/2002 Hoey et a1‘
`2002/0077632 A1
`6/2002 Tsou
`2002/0123780 A1
`9/2002 Grill et a1.
`2002/0161415 A1 10/2002 Cohen et a1,
`2002/0193843 A1 12/2002 Hill et al.
`2003/0032966 A1
`2/2003 Foley et al.
`2003/0105503 A1
`6/2003 MafiIlO
`2003/0139648 A1
`7/2003 Foley et a1~
`
`,
`
`,
`
`eweyet al.
`
`. “
`
`.
`
`.
`
`.
`
`.
`
`.
`
`Dezawa et al., “Retroperitoneal Laparoscopic Lateral Approach to
`the Lumbar Spine: A New Approach, Technique, and Clinical Trial,”
`Journal ofSpinal Disorders, 2000, 13(2): 138-143.
`Gardock1, Tubular d1skec-tomym1n1m1Zes collateral damage:Alog1
`081 progresslon moves splne Surgery forward,” AAOS NOW, 2009, 5
`PageS~
`Hovorka et al., “Five years’ experience of retroperitoneal lumbar and
`thoracolumbar surgery,” Eur Spine J, 2000, 9(1): S30-S34.
`Kossman et al., “The use ofa retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior column of the tho
`racic and lumbar spine,” Eur SpineJ, 2001, 10: 396-402.
`Mayer, “A New Microsurgical Technique for Minimally Invasive
`Anterior Lumbar Interbody Fusion,” Spine, 1997, 22(6): 691-699.
`“
`,,
`.
`‘
`Mayer, The ALIF Concept, Eur SplneJ, 2000, 9(1). S35-S43.
`Mayer and Wlechert, M1crosurg1cal Anter1or Approaches to the
`Lumbar Spine for Interbody Fusion and Total Disc Replacement,”
`Neurosurgery, 2002, 51(2) 159-165
`McAfee et al., “Minimally Invasive Anterior Retroperitoneal
`Approach to the Lumbar Spine: Emphasis on the Lateral BAK,”
`Spine, 1998, 23(13): 1476-1484.
`Rao, et al. “Dynamic retraction of the psoas muscle to expose the
`lumbar spine using the retroperitoneal approach,” J Neurosurg
`
`2003/0225405 A1 12/2003 Welner
`2003/0236544 A1 12/2003 Lunsford et al.
`2004/0199084 A1 10/2004 Kelleher et al.
`
`2004/0225228 A1 11/2004 Ferree
`Zoos/0004593 A1
`1/2005 Simonson
`2005/0004623 A1
`1/2005 Miles et a1‘
`2005/0033380 A1
`2/2005 Tanner et al.
`2005/007557g A1
`4/2005 Gharib et a1‘
`2005/00g0320 A1
`4/2005 Lee @131,
`2005/0149035 A1
`7/2005 Pimenta @131,
`2005/0182454 A1
`8/2005 Gharib et a1,
`2005/0192575 A1
`9/2005 Pacheco
`2006/0025703 A1
`2/2006 Miles et al.
`2006/0052828 A1
`3/2006 Kim et al.
`2006/0069315 A1
`3/2006 Miles et al.
`
`Wol?a et al., “Retroperitoneal lateral lumbar interbody fusion with
`ft .
`thr d d fu .
`,, J N
`S .
`1 2002 96‘
`1 amum ea e
`31°“ cages’
`-
`eurosurg ( We )1
`r
`'
`
`50'55~
`_
`_
`_
`Mayer and Brock, “Percutaneous endoscop1c discectomy: surg1cal
`technique and preliminary results compared to microsurgical
`discectomyr” 1- Neurosurg, 1993, 78: 216-225
`Schaffer and Kambin, “Percutaneous Posterolateral Lumbar
`Discectomy and Decompression with a 6.9-Millimeter Cannula,”
`The Journal ofBone and Joint Surgery, 1991, 73A(6): 822-831.
`Friedman,
`“Percutaneous discectomy: An alternative
`chemonucleolysis,” Neurosurgery, 1983, 13(5): 542-547.
`Crock, H.V. MD., “Anterior Lumbar Interbody Fusion,” Clinical
`Orthopaedics and Related Research, Number One Hundred Sixty
`Five, 1982, pp. 157-163, 13 pages.
`
`to
`
`
`
` 3
`
`
`
`

`

`US 8,192,356 B2
`Page 4
`
`Larson and Maiman, “Surgery of the Lumbar Spine,” Thieme Medi
`cal Publishers, Inc., 1999, pp. 305-319.
`Medtronic XOMED Surgical Products, Inc., NIM-Response Nerve
`Integrity Monitor Intraoperative EMG Monitor User’s Guide, Revi
`sion B, 2000, 47 pages.
`“NuVasive’s spine surgery system cleared in the US,” Pharm &
`Medical Industry Week, Dec. 10, 2001, 1 page.
`Pimenta, “Initial Clinical Results of Direct Lateral, Minimally
`Invasive Access to the Lumbar Spine for Disc Nucleus Replacement
`Using a Novel Neurophysiological Monitoring System.” The 9th
`IMAST, May 2002, 1 page.
`Pimenta et al., “The Lateral Endoscopic Transpsoas Retroperitoneal
`Approach (Letra) for Implants in the Lumbar Spine,” World Spine
`lliSecond Interdisciplinary Congress on Spine Care, Aug. 2003, 2
`pages.
`Anatomy of the Lumbar Spine in MED TM MicroEndoscopic
`Discectomy (1997 Ludann Grand Rapids MI), 14 pgs.
`Dirksmeier et al., “Microendoscopic and Open Laminotomy and
`Discectomy in Lumbar Disc Disease” Seminars in Spine Surgery,
`1999, 11(2): 138-146.
`METRx Delivered Order Form, 1999, 13 pages.
`Medtronic Sofamor Danek “METRxTM MicroDisectomy System,”
`Medtronic Sofamor Danek USA, 2000, 21 pgs.
`Medtronic Sofamor Danek “METRx System Surgical Technique,”
`2004, 22 pages.
`“MetRx System MicroEndoscopic Discectomy: An Evolution in
`Minimally Invasive Spine Surgery,” Sofamor Danek, 1999, 6 pages.
`Smith and Foley “MetRx System MicroEndoscopic Discectomy:
`Surgical Technique” Medtronic Sofamor Danek, 2000, 24 pages.
`“Sofamor Danek MED Microendoscopic Discectomy System Bro
`chure” including Rapp “New endoscopic lumbar technique improves
`access preserves tissue” Reprinted with permission from: Orthope
`dics Today, 1998, 18(1): 2 pages.
`Japanese Patent Of?ce JP Patent Application No. 2006-528306
`Of?ce Action with English Translation, Jun. 10, 2009, 4 pages.
`Plaintiffs’ Preliminary Invalidity Contentions re US Patents
`7207949; 7470236 and 7582058, Sep. 18, 2009, 19 pages.
`Plaintiffs’ Preliminary Invalidity ContentionsiAppendices, Sep.
`18, 2009, 191 pages.
`Plaintiffs’ Supplemental Preliminary Invalidity Contentions re US
`Patents 7207949, 7470236, and 7582058, Sep. 29, 2009, 21 pages.
`Plaintiffs’ Supplemental Preliminary Invalidity ContentionsiAp
`pendices, Sep. 29, 2009, 294 pages.
`Axon 501(k) Noti?cation: Epoch 2000 Neurological Workstation,
`Dec. 3, 1997, 464 pages.
`Foley and Smith, “Microendoscopic Discectomy,” Techniques in
`Neurosurgery, 1997, 3(4):301-307.
`Medtronic Sofamor Danek “UNIONTM / Union-LTM Anterior & Lat
`eral Impacted Fusion Devices: Clear choice of stabilization,”
`Medtronic Sofamor Danek, 2000, 4 pages.
`NuVasive VectorTM Cannulae, 1 page (prior to Sep. 25, 2003).
`NuVasive TriadTM Tri-Columnar Spinal EndoArthrodesisTM via
`Minimally Invasive Guidance, 1 page (prior to Sep. 25, 2003).
`NuVasive TriadTM Cortical Bone Allograft, 1 page (prior to Sep. 25,
`2003).
`NuVasive Vertebral Body Access System, 1 page (prior to Sep. 25,
`2003).
`Marina, “New Technology for Guided Navigation with Real Time
`Nerve Surveillance for Minimally Invasive Spine Discectomy &
`Arthrodesis,” Spineline, 2000, p. 39.
`NuVasive “INSiI Screw Test,” 2001, 10 pages.
`NuVasive letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5
`pages.
`NuVasive letter re 510k Guided Arthroscopy System, Oct. 5, 1999, 6
`pages.
`NuVasive letter re 510k INS-1 Intraoperative Nerve Surveillance
`System, Nov. 13, 2000, 7 pages.
`“NuVasivcTM Rcccivcs Clcarancc to Market Two Key Elcm Mini
`mally Invasive Spine Surgery System,” Nov. 27, 2001, 20 pages.
`Schick et al., “Microendoscopic lumbar discectomy versus open
`surgery: an intraoperative EMG study,” Eur Spine], 2002, 11: 20-26.
`NuVasive letter re: 510(k) for Neurovision JJB System (Summary),
`Sep. 25, 2001, 28 pages.
`
`NuVasive letter re: Special 510(k) Premarket Noti?cation: Neurovi
`sion JJB System (Device Description), Jul. 3, 2003, 18 pages.
`NuVasive letter re: Special 510(k) Premarket Noti?cation: Neurovi
`sion JJB System (Device Description), Mar. 1, 2004, 16 pages.
`NuVasive letter re: Special 510(k) Premarket Noti?cation: Neurovi
`sion JJB System (Device Description), May 26, 2005, 17 pages.
`NuVasive letter re: 510(k) Premarket Noti?cation: Neurovision JJB
`System (Device Description), Jun. 24, 2005, 16 pages.
`NuVasive letter re: Special 510(k) Premarket Noti?cation: Neurovi
`sion JJB System (Device Description), Sep. 14, 2006, 17 pages.
`NuVasive 510(k) Premarket Noti?cation: Neurovision JJB System
`(Device Description), Aug. 20, 2007, 8 pages.
`NuVasive letter re: 510(k) Premarket Noti?cation: Guided Spinal
`Arthroscopy System (Device Description), Feb. 1, 1999, 40 pages.
`NuVasive 510(k) Premarket Noti?cation: Spinal System (Summary),
`Apr. 12,2004, 10 pages.
`NuVasive 510(k) Summary NIM Monitor, Sep. 4, 1998, 4 pages.
`NuVasive correspondence re 510(k) Premarket Noti?cation INS-1
`Intraoperative Nerve Surveillance System: Section IV Device
`Description, pp. 12-51 (prior to Sep. 25, 2003).
`NuVasive letter re 510(k) Premarket Noti?cation INS-1 Intraopera
`tive Nerve Surveillance System, Aug. 24, 2000, 81 pages.
`Isley et al., “Recent Advances in Intraoperative Neuromonitoring of
`Spinal Cord Function: Pedicle Screw Stimulation Techniques,”
`American Journal of Electroneurodagnostic Technology, Jun. 1997,
`37(2): 93-126.
`Mathews et al., “Laparoscopic Discectomy with Anterior Lumbar
`Interbody Fusion,” Spine, 1995, 20(16): 1797-1802.
`Rose et al., “Persistently Electri?ed Pedicle Stimulation Instruments
`in Spinal Instrumentation: Techniques and Protocol Development,”
`Spine, 1997, 22(3): 334-343.
`“Electromyography System,” International Search report from Inter
`national Application No. PCT/US00/32329, Apr. 27, 2001, 9 pages.
`“Nerve Proximity and Status Detection System and Method,” Inter
`national Search Report from International Application No. PCT/
`US01/18606, Oct. 18, 2001, 6 pages.
`“Relative Nerve Movement and Status Detection System and
`Method,” International Search Report from International Application
`No. PCT/US01/18579, Jan. 15, 2002, 6 pages.
`“System and Method for Determining Nerve Proximity Direction
`and Pathology During Surgery,” International Search Report from
`International Application No. PCT/US02/22247, Mar. 27, 2003, 4
`pages.
`“System and Methods for Determining Nerve Direction to a Surgical
`Instrument,” International Search Report from International Appli
`cation No. PCT/US03/02056, Aug. 12, 2003, 5 pages.
`“Systems and Methods for Performing Percutaneous Pedicle Integ
`rity Assessments,” International Search Report from International
`Application No. PCT/US02/35047, Aug. 11, 2003, 5 pages.
`“Systems and Methods for Performing Surgery Procedures and
`Assessments,” International Search Report from International Appli
`cation No. PCT/US02/30617, Jun. 5, 2003, 4 pages.
`Lenke et al., “Triggered Electromyographic Threshold for Accuracy
`of Pedicle Screw Placement,” Spine, 1995, 20(4): 1585-1591.
`“Brackmann II EMG System,” Medical Electronics, 1999, 4 pages.
`“Neurovision SE Nerve Locator/Monitor”, RLN Systems Inc.
`Operators Manual, 1999, 22 pages.
`“The Brackmann II EMG Monitoring System,” Medical Electronics
`Co. Operator’s Manual Version 1.1, 1995, 50 pages.
`“The Nicolet Viking IV,” Nicolet Biomedical Products, 1999, 6
`pages.
`Anderson et al., “Pedicle screws with high electrical resistance: a
`potential source of error with stimulus-evoked EMG,” Spine, Depart
`ment of Orthopaedic Surgery University of Virginia, Jul. 15, 2002,
`27(14): 1577-1581.
`Bosc ct al., “Ncurophysiologic Monitoring of Spinal Ncrvc Root
`Function During Instrumented Posterior Lumber Spine Surgery,”
`Spine, 2002, 27(13): 1444-1450.
`Calancie et al., “Stimulus-Evoked EMG Monitoring During
`Transpedicular Lumbosacral Spine Instrumentation” Spine, 1994,
`19(24): 2780-2786.
`
`
`
` 4
`
`
`
`

`

`US 8,192,356 B2
`Page 5
`
`Clements et al., “Evoked and Spontaneous Electromyography to
`Evaluate Lumbosacral Pedicle Screw Placement,” Spine, 1996,
`21(5): 600-604.
`Danesh-Clough et al. ,“The Use of Evoked EMG in Detecting Mis
`placed Thoracolumbar Pedicle Screws,” Spine, Orthopaedic Depart
`ment Dunedin Hospital, Jun. 15, 2001, 26(12): 1313-1316.
`Darden et al., “A Comparison of Impedance and Electromyogram
`Measurements in Detecting the Presence of Pedicle Wall Break
`through,” Spine, Charlotte Spine Center North Carolina, Jan. 15,
`1998, 23(2): 256-262.
`Ebraheim et al., “Anatomic Relations Between the Lumbar Pedicle
`and the Adjacent Neural Structures,” Spine, Department of
`Orthopaedic Surgery Medical College of Ohio, Oct. 15, 1997,
`22(20): 2338-2341.
`Ford et al. “Electrical Characteristics of Peripheral Nerve Stimulators
`Implications for Nerve Localization,” Regional Anesthesia, 1984, 9:
`73-77.
`Glassman et al., “A Prospective Analysis of Intraoperative
`Electromyographic Monitoring of Pedicle Screw Placement With
`Computed Tomographic Scan Con?rmation,” Spine, 1995, 20(12):
`1375-1379.
`Greenblatt et al., “Needle Nerve Stimulator-Locator: Nerve Blocks
`with a New Instrument for Locating Nerves,” Anesthesia& Analge
`sia, 1962, 41(5): 599-602.
`Haig, “Point of view,” Spine, 2002, 27(24): 2819.
`Haig et al., “The Relation Among Spinal Geometry on MRI,
`Paraspinal Electromyographic Abnormalities, and Age in Persons
`Referred for Electrodiagnostic Testing of Low Back Symptoms,”
`Spine, Department of Physical Medicine and Rehabilitation Univer
`sity of Michigan, Sep. 1, 2002, 27(17): 1918-1925.
`Holland et al., “Higher Electrical Stimulus Intensities are Required to
`Activate Chronically Compressed Nerve Roots: Implications for
`Intraoperative Electromyographic Pedicle Screw Testing,” Spine,
`Department of Neurology, Johns Hopkins University School of
`Medicine, Jan. 15, 1998, 23(2): 224-227.
`Holland, “Intraoperative Electromyography During Thoracolumbar
`Spinal Surgery,” Spine, 1998, 23(17): 1915-1922.
`J ournee et al., “System for Intra-Operative Monitoring of the Cortical
`Integrity of the Pedicle During Pedicle Screw Placement in Low
`Back Surgery: Design and Clinical Results,” Sensory and
`Neuromuscular Diagnostic Instrumentation and Data Analysis I,
`18th Annual International Conference on Engineering in Medicine
`and Biology Society, Amsterdam, 1996, pp. 144-145.
`Maguire et al., “Evaluation of Intrapedicular Screw Position Using
`Intraoperative Evoked Electromyography,” Spine, 1995, 20(9): 1068
`1074.
`
`Martin et al. “Initiation of Erection and Semen Release by Rectal
`Probe Electrostimulation (RPE),” The Journal of Urology, The Wil
`liams& Wilkins Co., 1983, 129: 637-642.
`Minahan et al., “The Effect of Neuromuscular Blockade on Pedicle
`Screw Stimulation Thresholds” Spine, Department of Neurology,
`Johns Hopkins University School of Medicine, Oct. 1, 2000, 25(19):
`2526-2530.
`Pither et al., “The Use of Peripheral Nerve Stimulators for Regional
`Anesthesia: Review of Experimental Characteristics Technique and
`Clinical Applications,” RegionalAnesthesia, 1985, 10:49-58.
`Raj et al., “Infraclavicular Brachial Plexus BlockiA New
`Approach”Anesthesia andAnalgesia, 1973, (52)6: 897-904.
`Raj et al., “The Use of Peripheral Nerve Stimulators for Regional
`Anesthesia,” Clinical Issues in Regional Anesthesia, 1985, 1(4):1-6.
`Raj et al., “Use of the Nerve Stimulator for Peripheral Blocks,”
`RegionalAnesthesia, Apr-Jun. 1980, pp. 14-21.
`Raymond et al., “The Nerve Seeker: A System for Automated Nerve
`Localization,” RegionalAnesthesia, 1992, 17(3): 151-162.
`Sha?k, “Cavernous Nerve Simulation through an Extrapelvic
`Subpubic Approach: Role in Penile Erection,” Eur. Urol, 1994, 26:
`98-102.
`Toleikis et al., “The Usefulness of Electrical Stimulation for Assess
`ing Pedicle Screw Replacements,” Journal of Spinal Disorder, 2000,
`13(4): 283-289.
`Medtronic Sofamor Danek “UnionTM / Union-LTM Anterior & Lateral
`Impacted Fusion Devices: Surgical Technique” Medtronic Sofamor
`Danek, 2001, 20 pages.
`Defendant’s Disclosure of Asserted Claims and Preliminary
`Infringement Contentions Regarding USP 7207949; 7470236 and
`7582058, Aug. 31, 2009, 21 pages.
`Brau, “Chapter 22: Anterior Retroperitoneal Muscle-Sparing
`approach to L2-S1 of the Lumbar Spine,” Surgical Approaches to the
`Spine. Robert G. Watkins, MD. (ed) 2003. pp. 165-181.
`Kossmann et al., “Minimally Invasive Vertebral Replacement with
`Cages in Thoracic and Lumbar Spine,” European Journal of Trauma,
`2001,27: 292-300.
`Mayer H. M. (ed.) Minimally Invasive Spine Surgery.‘ A Surgical
`Manual. 2000. 51 pages.
`Pimenta et al., “Implante de protese de nucleo pulpost: analise
`inicial,” Journal Brasileiro de Neurocirurgia, 2001, 12(2): 93-96.
`Traynelis, “Spinal Arthroplasty,” Neurological Focus, 2002, 13(2):
`12 pages.
`Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999.
`43 pages.
`
`* cited by examiner
`
`
`
` 5
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 1 0f 33
`Sheet 1 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`
`
`
`
` 6
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 2 0f 33
`Sheet 2 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`
`
`FIG. 2
`FIG. 2
`
`
`
` 7
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 3 0f 33
`Sheet 3 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`
`
`
`
` 8
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 4 0f 33
`Sheet 4 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`12 1
`
`44
`( 204
`
`50
`
`202 52
`
`
`
`4;‘9
`
`206
`
`46
`p
`
`—_
`54
`
`
`
` 9
`
`
`
`

`

`U.S. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 5 0f 33
`Sheet 5 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`
`
`10
`
`
`
`10
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 6 0f 33
`Sheet 6 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`
`
`
`
`11
`
`
`
`

`

`US. Patent
`
`Jun. 5 2012
`
`Sheet 7 0f33
`
`
`
`
`
`12
`
`
`
`

`

`US. Patent
`
`Jun. 5 2012
`
`Sheet 8 0f33
`
`FIG. 8
`
`
`
`13
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 9 0f 33
`Sheet 9 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`90,92
`
`1
`
`98
`
`104
`
`FIG. 9
`FIG. 9
`
`14
`
`
`
`14
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 10 0f 33
`Sheet 10 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`90,92
`
`1
`
`
`
`
`
`15
`
`
`
`

`

`US. Patent
`US. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 11 of 33
`Sheet 11 0f 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`36 I
`
`106
`
`108
`
`
`
`110
`
`212
`
`FIG. 1]
`
`
`
`16
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`Jun. 5, 2012
`Jun. 5, 2012
`
`Sheet 12 0133
`Sheet 12 of 33
`
`US 8,192,356 B2
`US 8,192,356 B2
`
`126
`127 V/
`
`140
`
`
`
`132
`
`FIG. 12
`FIG. 12
`
`17
`
`
`
`17
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 13 0f 33
`
`US 8,192,356 B2
`
`NW1
`
`21
`
`
`
`5/ _| |||||||||||||||| _ _
`
`_ m
`
`A M872 m
`
`$1 m n
`
`wmQoEQmm 28% “ Q5 T 535 “
`
`Q5 “
`
`m m
`
`_ _
`
`_ m
`
`_ m
`
`
`292525 “ QNT _ m
`
`magi Q1 _ m
`
`220E525 $0613 |v mmzmz “ $23228 E55 852 m |v
`
`
`
`
`_ _ _ Emil “
`
`
`
`18
`
`
`
`

`

`U.S. Patent
`
`Jun. 5, 2012
`
`Sheet 14 of 33
`
`US 8,192,356 B2
`
`2:mm“
`
`
`
`..\aapmmxa<522<owzpfiaof;'93a2
`
`VLE
`31vE3@mm:2_mobja
`
`
`
`0")
`
`
`
`
`
`
`
`
`
`
`
`FNMV
`
`
`
`
`
`
`
`
`
`2:
`
`N:
`
`.UNK/m2
`
`
`
`mo_mm_._.z<m_._<_m__._.
`
`
`
`m>mwz._<m_zomm_n_
`
`o.
`
`
`
`o._o_._wm_m__._._.NE
`
`ENE
`
`19
`
`
`
`19
`
`
`
`
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 15 0f 33
`
`US 8,192,356 B2
`
`Q.
`
`EOIwmEIP
`
`E
`
`:1 Mai
`
`3/5‘ w m m
`
`m 53225 94:55 0 mm m z o % m
`
`
`
`20: MQZ<>Q< mm: 25955 F . F
`N R __ _ __ \ m_>_w<>Dz
`
`
`
`§\v 226 N N
`
`5 q W» q
`
`l . . d \v Q
`
`mm“
`
`k
`E“
`
`
`
`20
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 16 of 33
`
`US 8,192,356 B2
`
`
`
`FIG. 16
`
`21
`
`
`
`21
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 17 of 33
`
`US 8,192,356 B2
`
`
`
`22
`
`
`
`22
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 18 of 33
`
`US 8,192,356 B2
`
`
`
`
`
`23
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 19 of 33
`
`US 8,192,356 B2
`
`
`
`304
`
`FIG. 19
`
`24
`
`
`
`24
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 20 of 33
`
`US 8,192,356 B2
`
`
`
`304
`
`FIG. 20
`
`25
`
`
`
`25
`
`
`
`

`

`U.S. Patent
`
`US 8,192,356 B2
`
`
`
`FIG. 2]
`
`
`
`26
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 22 of 33
`
`US 8,192,356 B2
`
`
`
`27
`
`
`
`27
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 23 of 33
`
`US 8,192,356 B2
`
`
`
`28
`
`
`
`28
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 24 of 33
`
`US 8,192,356 B2
`
`
`
`29
`
`
`
`29
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 25 of 33
`
`US 8,192,356 B2
`
`
`
`304
`
`FIG. 25
`
`30
`
`
`
`30
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 26 of 33
`
`US 8,192,356 B2
`
`
`
`304
`
`FIG. 26
`
`31
`
`
`
`31
`
`
`
`

`

`U.S. Patent
`
`Jun. 5, 2012
`
`Sheet 27
`
`of 33
`
`US 8,192,356 B2
`
`
`
`FIG. 27
`
`
`
`32
`
`
`
`

`

`U.S. Patent
`
`Jun. 5, 2012
`
`Sheet 28 of 33
`
`US 8,192,356 B2
`
`
`
`FIG. 28
`
`33
`
`
`
`33
`
`
`
`

`

`U.S. Patent
`
`Jun. 5, 2012
`
`Sheet 29 of 33
`
`US 8,192,356 B2
`
`
`
`FIG. 29
`
`34
`
`
`
`34
`
`
`
`

`

`U.S. Patent
`
`Jun. 5, 2012
`
`Sheet 30 of 33
`
`US 8,192,356 B2
`
`
`
`
`
`
`
`35
`
`
`
`35
`
`
`
`

`

`US. Patent
`
`Jun. 5 2012
`
`Sheet 31 0f33
`
`
`
`
`
`36
`
`
`
`

`

`
`
`
`
`37
`
`
`
`

`

`US. Patent
`
`Jun. 5, 2012
`
`Sheet 33 of 33
`
`US 8,192,356 B2
`
`
`
`38
`
`
`
`38
`
`
`
`

`

`US 8,192,356 B2
`
`1
`SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`CROSS-REFERENCES TO RELATED
`APPLICATIONS
`
`This application is a continuation of US. patent Ser. No.
`12/428,081 filed onApr. 22, 2009, which is a continuation of
`US. patent application Ser. No. 10/608,362 filed on Jun. 26,
`2003 (now US. Pat. No. 7,582,058), which claims priority to
`US. Provisional Patent Application Ser. No. 60/392,214 filed
`Jun. 26, 2002 (the contents being incorporated herein by
`reference). The present application also incorporates by ref-
`erence the following co-assigned patent applications in their
`entireties: PCT App. Ser. No. PCT/USO2/22247, entitled
`“System and Methods for Determining Nerve Proximity,
`Direction, and Pathology During Surgery,” filed on Jul. 11,
`2002 (published as W003/005887); PCT App. Ser. No. PCT/
`USO2/30617, entitled “System and Methods for Performing
`Surgical Procedures andAssessments,” filed on Sep. 25, 2002
`(published as WO 03/026482); PCT App. Ser. No. PCT/
`USO2/35047, entitled “System and Methods for Performing
`Percutaneous Pedicle Integrity Assessments,” filed on Oct.
`30, 2002 (published as WO/03037170); and PCT App. Ser.
`No. PCT/USO3/02056, entitled “System and Methods for
`Determining Nerve Direction to a Surgical Instrument,” filed
`Jan. 15, 2003 (published as WO/2004064634).
`
`BACKGROUND
`
`I. Field
`
`The present invention relates generally to systems and
`methods for performing surgical procedures and, more par-
`ticularly, for accessing a surgical target site in order to per-
`form surgical procedures.
`II. Description of Related Art
`A noteworthy trend in the medical community is the move
`away from performing surgery via traditional “open” tech-
`niques in favor of minimally invasive or minimal access tech-
`niques. Open surgical techniques are generally undesirable in
`that they typically require large incisions and high amounts of
`tissue displacement to gain access to the surgical target site,
`which produces concomitantly high amounts of pain, length-
`ened hospitalization (increasing health care costs), and high
`morbidity in the patient population. Less-invasive surgical
`techniques (including so-called “minimal access” and “mini-
`mally invasive” techniques) are gaining favor due to the fact
`that they involve accessing the surgical target site via inci-
`sions of subs