`
`(75)
`
`Inventors: Luiz Pimenta, Sao Paulo (BR); Patrick
`Miles, San Diego, CA (US); Scot
`Martinelli, San Diego, CA (US); Eric
`Finley, San Diego, 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 154 days.
`This patent is subject to a terminal dis
`claimer.
`
`DE
`EP
`
`9/1878 Dorr
`208,227 A
`972,983 A 10/1910 Arthur
`1,328,624 A
`1/1920 Graham
`1,548,184 A
`8/1925 Cameron
`2,704,064 A
`6/1955 FiZZell et al.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`29908 259
`7/1999
`0 567 424
`10/1993
`(Continued)
`OTHER PUBLICATIONS
`
`(12) United States Patent
`Pimenta et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,591,432 B2
`*Nov. 26, 2013
`
`US008591432B2
`
`SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`(21)
`
`(22)
`
`(65)
`
`(63)
`
`(60)
`
`(51)
`
`(52)
`
`(58)
`
`Appl. N0.: 12/983,627
`
`Filed:
`
`Jan. 3, 2011
`
`Prior Publication Data
`
`US 2011/0098535 A1
`
`Apr. 28, 2011
`
`Related US. Application Data
`
`Continuation of application No. 12/635,869, ?led on
`Dec. 11, 2009, noW Pat. No. 8,303,515, and a
`continuation of application No. 10/967,668, ?led on
`Oct. 18, 2004, noW Pat. No. 7,905,840.
`
`Provisional application No. 60/512,594, ?led on Oct.
`17, 2003, provisional application No. 60/506,136,
`?led on Sep. 25, 2003.
`
`(2006.01)
`
`Int. Cl.
`A61B 5/05
`US. Cl.
`USPC ........................................................ .. 600/554
`Field of Classi?cation Search
`USPC ................... .. 600/554, 546; 606/41, 86 A, 79
`See application ?le for complete search history.
`
`“Electromyography System,” International Search report from Inter
`national Application No. PCT/US00/32329, Apr. 27, 2001, 9 pages.
`(Continued)
`
`Primary Examiner * Brian SZmal
`Assistant Examiner * Fangemonique Smith
`(74) Attorney, Agent, or Firm * Fish & Richardson RC.
`
`ABSTRACT
`(57)
`A surgical access system including a tissue distraction assem
`bly and a tissue retraction assembly, 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 structures before, during, and after the establishment
`of an operative corridor to a surgical target site. Some
`embodiments of the surgical access system may be particu
`larly suited for establishing an operative corridor to a surgical
`target site in the spine. Such an operative corridor may be
`established through the retroperitoneal space and the psoas
`muscle during a direct lateral, retroperitoneal approach to the
`spine.
`
`19 Claims, 50 Drawing Sheets
`
`
`
` 1
`
`NUVASIVE 1060
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2,736,002
`2,808,826
`3,364,929
`3,664,329
`3,682,162
`3,785,368
`3,830,226
`3,957,036
`4,099,519
`4,164,214
`4,207,897
`4,224,949
`4,226,228
`4,235,242
`4,285,347
`4,291,705
`4,461,300
`4,515,168
`4,519,403
`4,545,374
`4,561,445
`4,562,832
`4,573,448
`4,592,369
`4,595,018
`4,611,597
`4,616,635
`4,633,889
`4,658,835
`4,744,371
`4,759,377
`4,784,150
`4,807,642
`4,892,105
`4,913,134
`4,917,704
`4,926,865
`4,962,766
`4,964,411
`5,007,902
`5,015,247
`5,052,373
`5,058,602
`5,081,990
`5,092,344
`5,127,403
`5,161,533
`5,171,279
`5,192,327
`5,195,541
`5,196,015
`RE34,390
`5,255,691
`5,282,468
`5,284,153
`5,284,154
`5,295,994
`5,299,563
`5,312,417
`5,313,956
`5,313,962
`5,327,902
`5,331,975
`5,333,618
`5,342,384
`5,375,067
`5,375,594
`5,383,876
`5,395,317
`5,450,845
`5,472,426
`5,474,057
`5,474,558
`5,480,440
`5,482,038
`
`2/1956
`10/1957
`1/1968
`5/1972
`8/1972
`1/1974
`8/1974
`5/1976
`7/1978
`8/1979
`6/1980
`9/1980
`10/1980
`11/1980
`8/1981
`9/1981
`7/1984
`5/1985
`5/1985
`10/1985
`12/1985
`1/1986
`3/1986
`6/1986
`6/1986
`9/1986
`10/1986
`1/1987
`4/1987
`5/1988
`7/1988
`11/1988
`2/1989
`1/1990
`4/1990
`4/1990
`5/1990
`10/1990
`10/1990
`4/1991
`5/1991
`10/1991
`10/1991
`1/1992
`3/1992
`7/1992
`11/1992
`12/1992
`3/1993
`3/1993
`3/1993
`9/1993
`10/1993
`2/1994
`2/1994
`2/1994
`3/1994
`4/1994
`5/1994
`5/1994
`5/1994
`7/1994
`7/1994
`8/1994
`8/1994
`12/1994
`12/1994
`1/1995
`3/1995
`9/1995
`12/1995
`12/1995
`12/1995
`1/1996
`1/1996
`
`Oriel
`Reiner et al.
`Ide et al.
`Naylor
`Colyer
`McCarthy et al.
`Staub et al.
`Normann
`Warren
`Stark et al.
`Lloyd et al.
`Scott et al.
`Shin et al.
`Howson et al.
`Hess
`Severinghaus et al.
`Christensen
`Chester et al.
`Dickhudt
`Jacobson
`Berke et al.
`Wilder et al.
`Kambin
`Davis et al.
`Rantala
`Kraus
`Caspar et al.
`Talalla
`Pohndorf
`Harris
`Dykstra
`Voorhies et al.
`Brown
`Prass
`Luque
`Frey et al.
`Oman
`HerZon
`Johnson et al.
`Witt
`Michelson
`Michelson
`Brody
`Deletis
`Lee
`Brownlee
`Prass et al.
`Mathews
`Brantigan
`Obenchain
`Neubardt
`Culver
`Otten
`Klepinski
`Raymond et al.
`Raymond et al.
`Bonutti
`Seton
`Wilk
`Knutsson et al.
`Obenchain
`Lemmen
`Bonutti
`Lekhtman et al.
`Sugarbaker
`Berchin
`Cueva
`Nardella
`Kambin
`Axelgaard
`Bonati et al.
`Makower et al.
`Neubardt
`Kambin
`Ruff
`
`US 8,591,432 B2
`Page 2
`
`5,484,437
`5,509,893
`5,514,153
`5,540,235
`5,549,656
`5,560,372
`5,566,678
`5,569,290
`5,571,149
`5,579,781
`5,593,429
`5,599,279
`5,630,813
`5,667,508
`5,671,752
`5,681,265
`5,707,359
`5,711,307
`5,728,046
`5,741,253
`5,741,261
`5,759,159
`5,762,629
`5,772,661
`5,775,331
`5,776,144
`5,779,642
`5,785,658
`5,792,044
`5,797,854
`5,814,073
`5,830,151
`5,851,191
`5,853,373
`5,860,973
`5,862,314
`5,872,314
`5,885,210
`5,885,219
`5,888,196
`5,891,147
`5,902,231
`5,928,139
`5,928,158
`5,931,777
`5,935,131
`5,938,688
`5,944,658
`5,976,094
`6,004,262
`6,004,312
`6,007,487
`6,024,696
`6,027,456
`6,038,469
`6,038,477
`6,050,992
`6,074,343
`6,083,154
`6,095,987
`6,104,957
`6,104,960
`6,120,503
`6,126,660
`6,132,386
`6,132,387
`6,135,965
`6,139,493
`6,146,335
`6,152,871
`6,161,047
`6,174,311
`6,181,961
`6,196,969
`6,206,826
`6,217,509
`6,224,549
`6,259,945
`6,264,651
`
`1/1996
`4/1996
`5/1996
`7/1996
`8/1996
`10/1996
`10/1996
`10/1996
`11/1996
`12/1996
`1/1997
`2/1997
`5/1997
`9/1997
`9/1997
`10/1997
`1/1998
`1/1998
`3/1998
`4/1998
`4/1998
`6/1998
`6/1998
`6/1998
`7/1998
`7/1998
`7/1998
`7/1998
`8/1998
`8/1998
`9/1998
`11/1998
`12/1998
`12/1998
`1/1999
`1/1999
`2/1999
`3/1999
`3/1999
`3/1999
`4/1999
`5/1999
`7/1999
`7/1999
`8/1999
`8/1999
`8/1999
`8/1999
`11/1999
`12/1999
`12/1999
`12/1999
`2/2000
`2/2000
`3/2000
`3/2000
`4/2000
`6/2000
`7/2000
`8/2000
`8/2000
`8/2000
`9/2000
`10/2000
`10/2000
`10/2000
`10/2000
`10/2000
`11/2000
`11/2000
`12/2000
`1/2001
`1/2001
`3/2001
`3/2001
`4/2001
`5/2001
`7/2001
`7/2001
`
`Michelson
`Pracas
`Bonutti
`Wilson
`Reiss
`Cory
`Cadwell
`McAfee
`Liss et al.
`Cooke
`Ruff
`Slotman et al.
`Kieturakis
`Errico et al.
`Sinderby et al.
`Maeda et al.
`Bufalini
`Smits
`Mayer et al.
`Michelson
`MoskovitZ et al.
`MasrelieZ
`Kambin
`Michelson
`Raymond et al.
`Leysieffer et al.
`Nightengale
`Benaron
`Foley et al.
`Hedgecock
`Bonutti
`HadZic et al.
`GoZani
`Grif?th et al.
`Michelson
`Jeddeloh
`Clinton
`Cox
`Nightengale
`Bonutti
`MoskovitZ et al.
`Foley et al.
`Koros et al.
`Aristides
`Sava
`Bonutti et al.
`Schiff
`Koros et al.
`GoZani et al.
`Putz et al.
`Finneran
`Foley et al.
`Hoftman et al.
`Feler et al.
`Karlsson et al.
`Kayyali
`Nichols
`Nathanson et al.
`Liu et al.
`ShmulewitZ
`Alo et al.
`Duysens et al.
`Michelson
`DietZ
`GoZani et al.
`GoZani et al.
`Turner et al.
`Koros et al.
`GoZani
`Foley et al.
`King et al.
`Branch et al.
`Prass
`Bester et al.
`Mathews et al.
`Foley et al.
`Drongelen
`Epstein et al.
`Underwood et al.
`
`
`
` 2
`
`
`
`
`
`US 8,591,432 B2
`Page 3
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`6,266,558
`6,273,905
`6,292,701
`6,306,100
`6,308,712
`6,312,392
`6,325,764
`6,334,068
`6,348,058
`6,360,750
`6,371,968
`6,425,859
`6,425,901
`6,450,952
`6,451,015
`6,466,817
`6,468,205
`6,468,207
`6,500,128
`6,520,907
`6,524,320
`6,535,759
`6,564,078
`6,579,244
`6,620,157
`6,645,194
`6,679,833
`6,719,692
`6,760,616
`6,770,074
`6,796,985
`6,810,281
`6,819,956
`6,847,849
`6,849,047
`6,855,105
`6,869,398
`6,871,099
`6,902,569
`6,926,728
`6,929,606
`6,945,933
`6,951,538
`7,047,082
`7,050,848
`7,079,883
`7,089,059
`7,177,677
`7,198,598
`7,207,949
`7,226,451
`7,261,688
`7,470,236
`7,473,222
`7,481,766
`7,522,953
`7,556,601
`7,582,058
`7,643,884
`7,691,057
`7,717,959
`7,819,801
`7,935,051
`8,021,430
`8,251,997
`8,343,224
`2001/0039949
`2001/0056280
`2002/0007129
`2002/0010392
`2002/0072686
`2002/0077632
`2002/0123780
`2002/0161415
`2002/0193843
`
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B2
`B1
`B2
`B1
`B1
`B2
`B1
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B1
`B2
`B2
`B2
`B2
`B2
`B1
`B2
`B2
`B1
`B2
`B2
`B2
`B2
`B2
`B1
`B2
`B2
`B2
`B2
`B1
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`
`7/2001
`8/2001
`9/2001
`10/2001
`10/2001
`11/2001
`12/2001
`12/2001
`2/2002
`3/2002
`4/2002
`7/2002
`7/2002
`9/2002
`9/2002
`10/2002
`10/2002
`10/2002
`12/2002
`2/2003
`2/2003
`3/2003
`5/2003
`6/2003
`9/2003
`11/2003
`1/2004
`4/2004
`7/2004
`8/2004
`9/2004
`10/2004
`11/2004
`1/2005
`2/2005
`2/2005
`3/2005
`3/2005
`6/2005
`8/2005
`8/2005
`9/2005
`10/2005
`5/2006
`5/2006
`7/2006
`8/2006
`2/2007
`4/2007
`4/2007
`6/2007
`8/2007
`12/2008
`1/2009
`1/2009
`4/2009
`7/2009
`9/2009
`1/2010
`4/2010
`5/2010
`10/2010
`5/2011
`9/2011
`8/2012
`1/2013
`11/2001
`12/2001
`1/2002
`1/2002
`6/2002
`6/2002
`9/2002
`10/2002
`12/2002
`
`GoZani et al.
`Streeter
`Prass et al.
`Prass
`Shaw
`HerZon
`Grif?th et al.
`Hacker
`Melkent et al.
`Gerber et al.
`Kogasaka et al.
`Foley et al.
`Zhu et al.
`RiouX et al.
`Rittman, III et al.
`Kaula et al.
`Mollenauer et al.
`Fowler, Jr.
`Marino
`Foley et al.
`DiPoto
`Epstein et al.
`Marino et al.
`Goodwin
`Dabney et al.
`Briscoe et al.
`Smith et al.
`Kleffner et al.
`Hoey et al.
`Michelson
`Bolger et al.
`Brock et al.
`DiLorenZo
`Mamo et al.
`Goodwin
`Jackson, III et al.
`Obenchain et al.
`Whitehurst et al.
`Parmer et al.
`Zucherman et al.
`Ritland
`Branch
`Ritland
`Schrom et al.
`Hoey et al.
`Marino et al.
`Pless
`Kaula et al.
`Smith et al.
`Miles et al.
`ShluZas et al.
`Smith et al.
`Kelleher et al.
`Dewey et al.
`Lee et al.
`Kaula et al.
`Branch et al.
`Miles et al.
`Pond et al.
`Miles et al.
`William et al.
`Miles et al.
`Miles et al.
`Michelson
`Michelson
`Lynn et al.
`Loubser
`Underwood et al. ......... .. 606/41
`Marino
`Desai
`Hoey et al.
`Tsou
`Grill et al.
`Cohen et al.
`Hill et al.
`
`2/2003 Foley et al.
`2003/0032966 A1
`5/2003 Simonson
`2003/0083688 A1
`6/2003 Marino
`2003/0105503 A1
`7/2003 Foley et al.
`2003/0139648 A1
`8/2003 Clifton
`2003/0149341 A1
`2003/0225405 A1 12/2003 Weiner
`2003/0236544 A1 12/2003 Lunsford et al.
`2004/ 0199084 A1 10/2004 Kelleher et al.
`2004/0225228 A1 11/2004 Ferree
`2005/0004593 A1
`1/2005 Simonson
`2005/0004623 A1
`1/2005 Miles et al.
`2005/0033380 A1
`2/2005 Tanner et al.
`2005/0075578 A1
`4/2005 Gharib et al.
`2005/0080320 A1
`4/2005 Lee et al.
`2005/0149035 A1
`7/2005 Pimenta et al.
`2005/0182454 A1
`8/2005 Gharib et al.
`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.
`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
`EP
`2 795 624
`FR
`94/ 28824
`W0
`WO 00/38574
`W0
`WO 00/66217
`W0
`WO 00/67645
`W0
`WO 01/37728
`W0
`WO 02/54960
`W0
`W0 03/005887
`W0
`W0 03/026482
`W0
`WO 03/37170
`W0
`W0 WO 2005/013805
`W0 WO 2005/030318
`W0 WO 2006/042241
`WO
`2006/066217
`
`1/2000
`1/2001
`12/1994
`7/2000
`11/2000
`11/2000
`5/2001
`7/2002
`1/2003
`4/2003
`5/2003
`2/2005
`4/2005
`4/2006
`6/2006
`
`OTHER PUBLICATIONS
`
`“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.
`
`
`
` 3
`
`
`
`
`
`US 8,591,432 B2
`Page 4
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`“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.
`Bose et al., “Neurophysiologic Monitoring of Spinal Nerve 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.
`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 a1. “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 Medicane 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, John Hopkins University School of Medi
`cine, 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
`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.
`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 Contentions-Appendices, 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 Contentions-Appen
`dices, 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 &
`Lateral 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 “INS-1 Screw Test,” 2001, 10 pages.
`NuVasive letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5
`pages.
`
`
`
` 4
`
`
`
`
`
`US 8,591,432 B2
`Page 5
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`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.
`“NuVasiveTM Receives Clearance to Market Two Key Elem 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 SpineJ, 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.
`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.
`Bergey et al., “Endoscopic Lateral Transpsoas Approach to the Lum
`bar Spine,” Spine, 2004, 29(15): 1681-1688.
`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.
`Gardocki, “Tubular diskectomy minimizes collateral damage: A logi
`cal progression moves spine surgery forward,” AAOS Now, 2009, 5
`pages.
`Hovorka et a1 ., “Five years’ experience of retroperitoneal lumbar and
`thoracolumbar surgery,” Eur Spine J, 2000, 9(1): S30-S34.
`Kossman et al., “The use of a 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 Spine J, 2000, 9(1): S35-S43.
`Mayer and Wiechert, “Microsurgical Anterior Approaches to the
`Lumbar Spine for Interbody Fusion and Total Disc Replacemen ,”
`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.
`
`to
`
`Rao, et al. “Dynamic retraction of the psoas muscle to expose the
`lumbar spine using the retroperitoneal approach,” J Neurosurg
`Spine, 2006, 5: 468-470.
`Wol?a et al., “Retroperitoneal lateral lumbar interbody fusion with
`titanium threaded fusion cages,” J Neurosurg (Spine I), 2002, 96:
`50-55.
`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.
`Request for Inter Partes Reexamination in re US. Patent 7,905,840,
`dated Feb. 8, 2012, 204 pages.
`Traynelis, “Spinal Arthroplasty,” Neurological Focus, 2002, 13(2):
`12 pages.
`Zdeblick, Thomas A. (ed.). Anterior Approaches to the Spine. 1999.
`43 pages.
`Amended Complaint for Nu Vasive, Inc. v. Globus Medical, Inc. , Case
`No. 1:10-cv-0849 (D. Del., Oct. 5, 2010), 28 pages.
`Mayer and Brock, “Percutaneous endoscopic discectomy: surgical
`technique and preliminary results compared to microsurgical
`discectomy,” J 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, No. One Hundred Sixty Five,
`1982, pp. 157-163, 13 pages.
`Larson and Maiman, “Surgery of the Lumbar Spine,” Thieme Medi
`cal Publishers, Inc., 1999, pp. 305-319.
`Medtronic XOMED Surgical Products, Inc., NIMiResponse 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
`IIiSecond Interdisciplinary Congress on Spine Care, Aug. 2003, 2
`pages.
`Kossman et al., “The use of a retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior column of the tho
`racic and lumbar spine,” Eur Spine J, 2001, 10: 396-402.
`Kossman et al., “The use of a retractor system (SynFrame) for open,
`minimal invasive reconstruction of the anterior col. Of the thoracic
`and lumbar spine,” Eur Spine J, 2001, 10: 396-402.
`de Peretti et al., “New possibilities in L2 -L5 lumbar arthrodesis using
`a lateral retroperitoneal approach assisted by laparoscopy: prelimi
`nary results,” Eur Spine J, 1996, 5: 210-216.
`Litwin et al., “Hand-assisted laparoscopic surgery (HALS) with the
`handport system,” Annals of Surgery, 2000, 231(5): 715-723.
`Acland’s Video Atlas of Human Anatomy, Section 3.1.7:
`Paravertebral Muscles. Available online: http://aclandanatomy.com/
`abstract/4010463. Accessed Jul. 11, 2012.
`MedlinePlus, a Service of the US National Library of Medicine and
`National Institutes of Health. Available online: http://www.nlm.nih.
`gov/medlineplus/. Accessed Jul. 11, 2012.
`Pimenta et al., “Endoscopic Approach to the Cervical Spine,” 7’h
`World Congress of Endoscopic Surgery, Singapore. Lomanto et al.
`eds., 2000. 9 pages.
`Principles of Spinal Surgery, Vol. 2. MeneZes et al. eds., 1996. 11
`pages.
`
`
`
` 5
`
`
`
`
`
`US 8,591,432 B2
`Page 6
`
`(56)
`
`References Cited
`
`OTHER PUBLICATIONS
`
`“Chapter 7: Lumbar and thoracolumbar approaches for body or
`interbody lesions,” Manual of Spinal Surgery. Jenkins et al eds.,
`1981.10 pages.
`INS-1 Intraoperative Nerve Surveillance System, 2000, 81 pages.
`Principles and Practice ofSpine Surgery. Vaccaro et al. eds., 2003, 14
`pages.
`Master Cases Spine Surgery. Vaccarro et al. eds., 2001. 12 pages.
`Globus Medical, Inc., Globus ’s Supplemental Invalidity Contentions
`for US. Patent No. 7,905,840 (Nov. 29, 2012), 60 pages.
`
`Deposition of LuiZ Pimenta, M.D., NuVasive Inc. v. Globus Medical,
`Inc., at pp. 78-89, 122-133, and 138-141 and Exhibit 8 (May 9, 2012),
`21 pages.
`Baulot et al., Adjuvant Anterior Spinal Fusion Via Thorascopy, Lyon
`Chirurgical, 1994, 90(5): 347-351 including English Translation and
`Certi?cate of Translation.
`Leu et al., “Percutaneous Fusion of the Lumbar Spine,” Spine, 1992,
`6(3): 593-604.
`Rosenthal et al., “Removal of a Protruded Thoracic Disc Using
`Microsurgical Endoscopy,” Spine, 1994, 19(9): 1087-1091.
`
`* cited by examiner
`
`
`
` 6
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 1 0f50
`
`US 8,591,432 B2
`
`FIG. 1
`
`
`
` 7
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 2 0f50
`
`US 8,591,432 B2
`
`FIG. 2
`
`
`
` 8
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 3 0f50
`
`US 8,591,432 B2
`
`FIG. 3
`
`
`
` 9
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 4 0f50
`
`US 8,591,432 B2
`
`
`
`10
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 5 0f50
`
`US 8,591,432 B2
`
`FIG. 5
`
`
`
`11
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 6 0f50
`
`US 8,591,432 B2
`
`
`
`12
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 7 0f50
`
`US 8,591,432 B2
`
`FIG. 7
`
`
`
`13
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 8 0f50
`
`US 8,591,432 B2
`
`FIG. 8
`
`
`
`14
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 9 0f50
`
`US 8,591,432 B2
`
`FIG. 9
`
`
`
`15
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 10 0f50
`
`US 8,591,432 B2
`
`
`
`16
`
`
`
`
`
`US. Patent
`US. Patent
`
`Nov. 26, 2013
`Nov. 26, 2013
`
`Sheet 11 0150
`Sheet 11 0150
`
`US 8,591,432 B2
`US 8,591,432 B2
`
`
`
`FIG.11
`: .UE
`
`a
`00
`V
`
`48b
`
`42
`
`17
`
`
`
`17
`
`
`
`
`
`US. Patent
`US. Patent
`
`Nov. 26, 2013
`Nov. 26, 2013
`
`Sheet 12 0150
`Sheet 12 0150
`
`US 8,591,432 B2
`US 8,591,432 B2
`
`FIG.12
`
`Nm
`
`NH .OE
`
`18
`
`
`
`18
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 13 0f50
`
`US 8,591,432 B2
`
`42
`
`52
`
`N“ 54
`
`26
`
`o‘fLgluYnl
`
`HI0
`
`I
`
`I
`
`l
`
`20
`
`42
`
`FIG. 13
`
`
`
`19
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 14 0f50
`
`US 8,591,432 B2
`
`FIG. 14
`
`
`
`20
`
`
`
`
`
`U.S. Patent
`
`NOV. 26, 2013
`
`Sheet 15 of 50
`
`US 8,591,432 B2
`
`/-10
`
`
`
`21
`
`
`
`21
`
`
`
`
`
`U.S. Patent
`
`NOV. 26, 2013
`
`Sheet 16 of 50
`
`US 8,591,432 B2
`
`Uh...
`AI...IIa:
`."i':H...I-_.5SEE—gig...EC.
`
`
`
`mI
`
`22
`
`
`
`22
`
`
`
`
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 17 of 50
`
`US 8,591,432 B2
`
`
`
`FIG. 17
`
`23
`
`
`
`23
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 18 of 50
`
`US 8,591,432 B2
`
`
`
`FIG. 18
`
`24
`
`
`
`24
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 19 of 50
`
`US 8,591,432 B2
`
`
`
`25
`
`
`
`25
`
`
`
`
`
`U.S. Patent
`
`NOV. 26, 2013
`
`Sheet 20 of 50
`
`US 8,591,432 B2
`
`
`
`I.l::::5:
`
`mmmUo<
`
`$3.NmH
`
`
`
`
`
`mMOHUmZZOUSaga
`
`ZOEQADEHM
`
`mQOZ<
`
`ONT/
`
`cm.05
`
`26
`
`
`
`26
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 21 0150
`
`US 8,591,432 B2
`
`FIG.21
`
`X.»180
`
`DlRECTlON
`
`DETECTION
`
`
`
`TIBIALISANTERIOR
`
`
`
`PERONEALNERVE
`
`183
`
`181
`
`27
`
`l E
`
`QNuVasive
`
`HOLD
`
`ADVANCE
`
`m(
`
`/2
`:3
`
`
`
`DILATOR/CANNULA
`
`E9
`
`4 84
`
`:
`:1
`c:
`
`
`
`27
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 22 of 50
`
`US 8,591,432 B2
`
`E
`
`
`
`FIG.22
`
`
`
`DIRECTION
`
`DETECTION
`
`X.»—180
`
`183
`
`m g
`
`é
`5‘5
`§§
`
`330
`mm
`
`181
`
`28
`
`C)NuVasive
`
`
`
`28
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 23 of 50
`
`US 8,591,432 B2
`
`
`
`
`
`
`
`FIG.23
`
`29
`
`
`
`29
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 24 of 50
`
`US 8,591,432 B2
`
`
`
`FIG. 24
`
`30
`
`
`
`30
`
`
`
`
`
`US. Patent
`
`Nov. 26, 2013
`
`Sheet 25 of 50
`
`US 8,591,432 B2
`
`
`
`FI