`Gharib et a].
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,000,782 B2
`Aug. 16, 2011
`
`US008000782B2
`
`(54) SYSTEM AND METHODS FOR
`PERFORMING SURGICAL PROCEDURES
`AND ASSESSMENTS
`
`(75) Inventors: 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); Eric Finley, San
`gig? g?
`Sc“ Martmen" San
`g ’
`(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 128 days.
`
`21 A 1. N0.: 12/628 549
`(
`)
`pp
`’
`(22) Filed:
`Dec. 1, 2009
`
`(65)
`
`Prior Publication Data
`
`Mar' 25> 2010
`Us 2010/0076335 A1
`R l t d U s A l_
`t_ D t
`eae .
`. ppicaion aa
`
`(60) Division of application No. 12/426,792, ?led on Apr.
`20, 2009, Which is a continuation of application No.
`10/809’280’ ?led _On Mar; 251 2004’ new Pat‘ No‘
`7’522’953’ Whlch 1S a Commuanon of apphcanon NO‘
`PCT/US02/30617’ ?led on Sep' 25’ 2002'
`I t Cl
`1411623 /04
`A61B 5/05
`A 613 18/04
`A 61N 1/00
`
`51
`(
`)
`
`2006 01
`(2006'01)
`(2006'01)
`(2006'01)
`(
`'
`)
`620/526; 602/554; 60662665135141;
`600/554; 606/32, 53, 191; 607/2, 115*117
`See application ?le for complete search history.
`
`1e
`
`0
`
`ass1 ca 1011 earc ................ ..
`
`,
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`208,227 A
`9/1878 Dorr
`972,983 A 10/1910 Arthur
`1,328,624 A
`V1920 Graham
`2
`gamelrlori 1
`2’736’002 A
`e a '
`’
`’
`
`21956
`d
`C t.
`( on mue )
`FOREIGN PATENT DOCUMENTS
`299 08 259
`7/1999
`(Continued)
`
`DE
`
`OTHER PUBLICATIONS
`Anatomy of the Lumbar Spine in MED TM MicroEndoscopic
`Discectomy (1997 Ludann Grand Rapids MI), 14 pgs.
`
`(Continued)
`
`Primary Examiner * Max Hindenburg
`Asszslanl Exammer * Jonathan M Foreman
`(74) Attorney, Agent, or Firm * Jonathan Spangler; Rory
`Schermerhorn; Fish & Richardson P.C.
`
`ABSTRACT
`(57)
`The present invention involves systems and related methods
`for performing surgical procedures and assessments, includ
`ing the use of neurophysiology-based monitoring to: (a)
`determine nerve proximity and nerve direction to surgical
`instruments employed in accessing a surgical target site; (b)
`assess the pathology (health or status) ofa nerve or nerve root
`before, during, or after a surgical procedure; and/or (c) assess
`pedicle integrity before, during or after pedicle screW place
`ment, all in an automated, easy to use, and easy to interpret
`fashion S0 215 I0 provide a Surgeon-driven system,
`
`21 Claims, 31 Drawing Sheets
`
`
`
` 1
`
`NUVASIVE 1061
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`
`
`US. PATENT DOCUMENTS
`10/1957
`2,808,826
`Reiner et al.
`1/1968
`3,364,929
`Ide et al.
`Naylor
`5/1972
`3,664,329
`Colyer
`8/1972
`3,682,162
`McCarthy et al.
`1/1974
`3,785,368
`3,830,226
`8/1974
`Staub et al.
`3,957,036
`5/1976
`Normann
`4,099,519
`7/1978
`Warren
`4,164,214
`8/1979
`Stark et al.
`Lloyd et al.
`4,207,897
`6/1980
`4,224,949
`9/1980
`Scott et al.
`4,226,228
`10/1980
`Shin et al.
`4,235,242
`11/1980
`Howson et al.
`4,285,347
`8/1981
`Hess
`Severinghaus et al.
`4,291,705
`9/1981
`4,461,300
`Christensen
`7/1984
`4,515,168
`5/1985
`Chester et al.
`4,519,403
`Dickhudt
`5/1985
`4,545,374
`Jacobson
`10/1985
`4,561,445
`12/1985
`Berke et al.
`4,562,832
`1/1986
`Wilder et al.
`4,573,448
`Kambin
`3/1986
`4,592,369
`6/1986
`Davis et al.
`4,595,018
`Rantala
`6/1986
`4,611,597
`9/1986
`Kraus
`4,616,660
`Johns
`10/1986
`4,633,889
`Talalla
`1/1987
`4,658,835
`Pohndorf
`4/1987
`4,744,371
`Harris
`5/1988
`Dykstra
`4,759,377
`7/1988
`4,784,150
`11/1988
`Voorhies et al.
`4,807,642
`2/1989
`Brown
`4,892,105
`1/1990
`Prass
`Luque
`4,913,134
`4/1990
`4,926,865
`5/1990
`Oman
`4,962,766
`10/1990
`HerZon
`4,964,411
`10/1990
`Johnson et al.
`5,007,902
`Witt
`4/1991
`Brody
`5,058,602
`10/1991
`5,081,990
`Deletis
`1/1992
`5,092,344
`3/1992
`Lee
`5,125,406
`6/1992
`Goldstone et al.
`5,127,403
`Brownlee
`7/1992
`5,161,533
`11/1992
`Prass et al.
`5,171,279
`Mathews
`12/1992
`5,195,541
`Obenchain
`3/1993
`5,196,015
`Neubardt
`3/1993
`RE34,390
`Culver
`9/1993
`5,255,691
`10/1993
`Otten
`Klepinski
`5,282,468
`2/1994
`Raymond et al.
`5,284,153
`2/1994
`Raymond et al.
`5,284,154
`2/1994
`5,295,994
`Bonutti
`3/1994
`5,299,563
`4/1994
`Seton
`5,312,417
`Wilk
`5/1994
`5,313,956
`5/1994
`Knutsson et al.
`5,313,962
`Obenchain
`5/1994
`5,327,902
`7/1994
`Lemmen
`5,331,975
`Bonutti
`7/1994
`5,333,618
`8/1994
`Lekhtman et al.
`Sugarbaker
`5,342,384
`8/1994
`5,375,067
`Berchin
`12/1994
`5,378,241
`Haindl
`1/1995
`5,383,876
`Nardella
`1/1995
`5,395,317
`Kambin
`3/1995
`Alexgaard
`5,450,845
`9/1995
`5,474,558
`Neubardt
`12/1995
`5,480,440
`Kambin
`1/1996
`5,482,038
`Ruff
`1/1996
`5,484,437
`Michelson
`1/1996
`5,509,893
`4/1996
`Pracas
`5,514,153
`Bonutti
`5/1996
`5,540,235
`Wilson
`7/1996
`5,549,656
`Reiss
`8/1996
`Cory
`5,560,372
`10/1996
`5,566,678
`Cadwell
`10/1996
`5,569,248
`Matthews
`10/1996
`5,571,149
`11/1996
`Liss et al.
`
`US 8,000,782 B2
`Page 2
`
`5,579,781
`5,593,429
`5,599,279
`5,601,608
`5,630,813
`5,667,508
`5,671,752
`5,681,265
`5,707,359
`5,711,307
`5,728,046
`5,741,253
`5,759,159
`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
`5,817,071
`5,830,151
`5,851,191
`5,853,373
`5,860,973
`5,862,314
`5,872,314
`5,885,219
`5,888,196
`5,902,231
`5,928,139
`5,928,158
`5,935,131
`5,938,688
`5,944,658
`5,976,094
`5,976,146
`6,004,262
`6,004,312
`6,007,487
`6,011,985
`6,027,456
`6,038,469
`6,038,477
`6,050,992
`6,074,343
`6,095,987
`6,104,957
`6,104,960
`6,119,068
`6,120,503
`6,126,660
`6,128,576
`6,132,386
`6,132,387
`6,135,965
`6,139,493
`6,139,545
`6,146,335
`6,146,371
`6,152,871
`6,161,047
`6,174,311
`6,181,961
`6,196,969
`6,206,826
`6,217,509
`6,217,527
`6,221,049
`6,224,549
`6,231,546
`6,259,945
`6,266,558
`6,270,505
`6,273,905
`6,292,701
`6,306,100
`
`12/1996
`1/1997
`2/1997
`2/1997
`5/1997
`9/1997
`9/1997
`10/1997
`1/1998
`1/1998
`3/1998
`4/1998
`6/1998
`6/1998
`6/1998
`7/1998
`7/1998
`7/1998
`7/1998
`8/1998
`8/1998
`9/1998
`10/1998
`11/1998
`12/1998
`12/1998
`1/1999
`1/1999
`2/1999
`3/1999
`3/1999
`5/1999
`7/1999
`7/1999
`8/1999
`8/1999
`8/1999
`11/1999
`11/1999
`12/1999
`12/1999
`12/1999
`1/2000
`2/2000
`3/2000
`3/2000
`4/2000
`6/2000
`8/2000
`8/2000
`8/2000
`9/2000
`9/2000
`10/2000
`10/2000
`10/2000
`10/2000
`10/2000
`10/2000
`10/2000
`11/2000
`11/2000
`11/2000
`12/2000
`1/2001
`1/2001
`3/2001
`3/2001
`4/2001
`4/2001
`4/2001
`5/2001
`5/2001
`7/2001
`7/2001
`8/2001
`8/2001
`9/2001
`10/2001
`
`Cooke
`Ruff
`Slotman et al.
`Mouchawar
`Kieturakis
`Errico et al.
`Sinderby et al.
`Maeda et al.
`Bufalini
`Smits
`Mayer et al.
`Michelson
`MasrelieZ
`Kambin
`Michelson
`Raymond et al.
`Leysieffer et al.
`Nightengale
`Benaron
`Foley et al.
`Hedgecock
`Bonutti
`Dewindt et al.
`HadZic et al.
`GoZani
`Grif?th et al.
`Michelson
`Jeddeloh
`Clinton
`Nightengale
`Bonutti
`Foley et al.
`Koros et al.
`Aristides
`Bonutti et al.
`Schiff
`Koros et a1.
`GoZani et al.
`Ogawa et al.
`Putz et al.
`Finnerman
`Foley et al.
`Athan et al.
`Feler et al.
`Karlsson et al.
`Kayyali
`Nichols
`Nathanson et al.
`ShmulewitZ
`Alo et al.
`Duysens et al.
`Kannonji
`Michelson
`DietZ
`Nishimoto
`GoZani et al.
`GoZani et al.
`Turner et al.
`Koros et al.
`Utley
`GoZani
`DeWindt et al.
`Foley et al.
`King et al.
`Branch et al.
`Prass
`Bester et al.
`Mathews et al.
`Foley et al.
`Selmon et al.
`Selmon et al.
`Drongelen
`Milo et al.
`Epstein et al.
`GoZani et al.
`Yoshida et al.
`Streeter
`Prass et al.
`Prass
`
`
`
` 2
`
`
`
`
`
`6,312,392
`6,325,764
`6,334,068
`6,348,058
`6,393,325
`6,395,007
`6,425,859
`6,425,901
`6,447,484
`6,451,015
`6,466,817
`6,468,205
`6,468,207
`6,500,128
`6,507,755
`6,514,217
`6,520,907
`6,524,320
`6,535,759
`6,564,078
`6,579,244
`6,582,441
`6,585,638
`6,618,626
`6,620,157
`6,641,613
`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
`6,902,569
`6,916,330
`6,926,728
`6,929,606
`6,945,933
`7,008,431
`7,047,082
`7,050,848
`7,079,883
`7,089,059
`7,177,677
`7,198,598
`7,207,949
`7,226,451
`7,258,688
`7,276,055
`7,294,127
`7,310,546
`7,311,719
`7,470,236
`7,582,058
`2001/0039949
`2001/0056280
`2002/0007129
`2002/0010392
`2002/0072686
`2002/0123780
`2002/0161415
`2002/0193843
`2003/0032966
`2003/0078618
`2003/0105503
`2003/0139648
`2003/0149341
`2003/0225405
`2004/0181231
`2004/0199084
`2004/0225228
`2005/0004593
`2005/0004623
`2005/0033380
`2005/0075578
`
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B2
`B1
`B1
`B1
`B2
`B1
`B1
`B2
`B1
`B1
`B2
`B1
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B1
`B2
`B2
`B1
`B2
`B2
`B2
`B2
`B1
`B2
`B2
`B2
`B2
`B1
`B1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`
`11/2001
`12/2001
`12/2001
`2/2002
`5/2002
`5/2002
`7/2002
`7/2002
`9/2002
`9/2002
`10/2002
`10/2002
`10/2002
`12/2002
`1/2003
`2/2003
`2/2003
`2/2003
`3/2003
`5/2003
`6/2003
`6/2003
`7/2003
`9/2003
`9/2003
`11/2003
`11/2003
`1/2004
`4/2004
`7/2004
`8/2004
`9/2004
`10/2004
`11/2004
`1/2005
`2/2005
`2/2005
`6/2005
`7/2005
`8/2005
`8/2005
`9/2005
`3/2006
`5/2006
`5/2006
`7/2006
`8/2006
`2/2007
`4/2007
`4/2007
`6/2007
`8/2007
`10/2007
`11/2007
`12/2007
`12/2007
`12/2008
`9/2009
`11/2001
`12/2001
`1/2002
`1/2002
`6/2002
`9/2002
`10/2002
`12/2002
`2/2003
`4/2003
`6/2003
`7/2003
`8/2003
`12/2003
`9/2004
`10/2004
`11/2004
`1/2005
`1/2005
`2/2005
`4/2005
`
`HerZon
`Grif?th et al.
`Hacker
`Melkent et al.
`Mann et al.
`Bhatnagar et al.
`Foley et al.
`Zhu et al.
`Briscoe et al.
`Rittman, III et al.
`Kaula et al.
`Mollenauer et al.
`Fowler, Jr.
`Marino
`Turner et al.
`Selmon et al.
`Foley et al.
`DiPoto
`Epstein et al.
`Marino et al.
`Goodwin
`He et al.
`Yamamoto
`West et al.
`Dabney et al.
`Sennett
`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.
`Parmer et al.
`Simonson
`Zucherman et al.
`Ritland
`Branch
`Simonson
`Schrom et al.
`Hoey et al.
`Marino et al.
`Pless
`Kaula et al.
`Smith et al.
`Miles et al.
`ShluZas et al.
`Shah et al.
`Dewindt et al.
`Leung et al.
`Prass
`Bonutti
`Kelleher et al.
`Miles et al.
`Loubser
`Underwood et al.
`Marino
`Desai
`Hoey et al.
`Grill et al.
`Cohen et al.
`Hill et al.
`Foley et al.
`Fey et al.
`Marino
`Foley et al.
`Clifton
`Weiner
`Emstad et al.
`Kelleher et al.
`Ferree
`Simonson
`Miles et al.
`Tanner et al.
`Gharib et al.
`
`US 8,000,782 B2
`Page 3
`
`4/2005 Simonson et al.
`2005/0080418 A1
`6/2005 Burloin
`2005/0119660 A1
`7/2005 Pimenta et al.
`2005/0149035 A1
`8/2005 Gharib et al.
`2005/0182454 A1
`9/2005 Pacheco
`2005/0192575 A1
`2005/0256582 A1 11/2005 Feree
`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
`2008/0015612 A1
`1/2008 Urmey
`2008/0039914 A1
`2/2008 Cory et al.
`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.
`
`EP
`EP
`FR
`FR
`JP
`JP
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`FOREIGN PATENT DOCUMENTS
`0 759 307
`2/1997
`0 972 538
`1/2000
`2 795 624
`1/2001
`2 796 846
`2/2001
`11-076430
`3/1999
`2001-170190
`6/2001
`00/38574
`7/2000
`00/62660
`10/2000
`00/66217
`11/2000
`00/67645
`11/2000
`01/03604
`1/2001
`01/37728
`5/2001
`02/054960
`7/2002
`03/005887
`1/2003
`03/026482
`4/2003
`03/037170
`5/2003
`2004/012809
`2/2004
`2005/013805
`2/2005
`2005/030318
`4/2005
`2006/042241
`4/2006
`2006/066217
`6/2006
`
`OTHER PUBLICATIONS
`
`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.
`
`
`
` 3
`
`
`
`
`
`US 8,000,782 B2
`Page 4
`
`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, 2000, 1 page.
`NuVasive TriadTM Tri-Columnar Spinal EndoArthrodesisTM via
`Minimally Invasive Guidance, 2000, 1 page.
`NuVasive TriadTM Cortical Bone Allograft, 2000, 1 page.
`NuVasive Vertebral Body Access System, 2000, 1 page.
`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.
`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 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.
`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 al ., “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 Spine J., 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 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
`Spine, 2006, 5: 468-470.
`Wol?a et al., “Retroperitoneal lateral lumbar interbody fusion with
`titanium threaded fusion cages,” J'. Neurosurg (Spine 1), 2002, 96:
`50-55.
`NuVasive letter re 510(k) Premarket Noti?cation INS-1 Intraopera
`tive Nerve Surveillance System, Aug. 24, 2000, 81 pages (Dupli
`cateiparts already listed).
`Larson, Sanford J. et al., “Surgery of the Lumbar Spine,” 1999, pp.
`305 -3 19.
`Medtronic Xomed Surgical Products, Inc. “NIM-Response Nerve
`Integrity Monitor Intraoperative EMG Monitor User’s Guide, Revi
`sion B,” 2000.
`“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.
`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.
`
`
`
` 4
`
`
`
`
`
`US 8,000,782 B2
`Page 5
`
`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.
`Moed et al., “Insertion of an iliosacral implant in an animal model,”
`Journal of Bone and Joint Surgery, Nov 1999, 81A(11): 1529-1537.
`“NIM-Response, so advanced. . .yet so simple,”XoMed, Inc., 1999,
`12 pages.
`Moed et al., “Intraoperative monitoring with stimulus-evoked
`electromyography during placement of iliosacral screws,” The Jour
`nal of Bone and Joint Surgery, Apr. 1998, 81A(4): 10 pages.
`“New data analyzer combines the functions of siX instruments in one
`unit” News Release, Nov. 11, 1987, 3 pages.
`“NuVasive’s spine surgery system cleared in the US,” Pharm &
`Medical Industry Week, Dec. 10, 2001, 1 page.
`“Risk Capital Funds,” Innovation, Mar. 6, 1990, 172: 3 pages.
`Pimenta, Luiz. “Initial Clinical Results of Direct Lateral, Minimally
`Invasive Access to the Lumbar Spine for Disc Nucleus Replacement
`Using a Novel Neurophysiologica Monitoring System.” The 9th
`IMAST: May 2002. 1 page.
`“The Lateral Endoscopic Transpsoas Retroperitoneal Approach
`(Letra) for Implants in the Lumbar Spine” Second Interdisciplinary
`Congress on Spine Care World Spine II: Aug. 2003. 2 pages.
`
`
`
` 5
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 1 0131
`
`US 8,000,782 B2
`
`10\
`
`Stimulating One or More Electrodes on
`21 Surgical Accessory
`
`Measuring the Responses of Nerves
`innervated Based on Said Stimulation
`of Previous Step
`
`Determining the Relationship Between
`the Surgical Accessory and the Nerve
`Based on Said Measured Response
`
`Communicating the Relationship
`Between the Surgical Accessory and
`the Nerve to the User
`
`FIG. 1
`
`
`
` 6
`
`
`
`
`
`US. Patent
`U.S. Patent
`
`Aug. 16, 2011
`Aug. 16, 2011
`
`Sheet 2 0131
`Sheet 2 of 31
`
`US 8,000,782 B2
`US 8,000,782 B2
`
`27
`
`27
`
`
`
`29
`
`HS. 2
`
`
`
` 7
`
`
`
`
`
`U.S. Patent
`
`a7,
`
`2
`
`Bm.99.»
`
`
`
` ow“E3gangW“cacao...Emmmmmm€84m2,commmmezm”6M1Mggnaw:HNu..Abewmmoofimfiommmmou<m«wuwmfidmH”mumhamm
`
` 0“ii-----§-§§------3.0~M0,ommw8._s1wmUywCGEEOOGENHmma:9m.........mmmficbuwmw
`62m@395”m1Hw3~fw0w3“
`
`
`
`vm
`
`
`
`.vmfimdemdmva
`
`lllllllllllllllllllllllllllll
`
`
`
` 8
`
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 4 0131
`
`US 8,000,782 B2
`
`Stim
`Current *
`
`ZOOPS
`
`/ ISTIM
`
`EMG
`Voltage
`
`>
`Time
`
`>
`Time
`
`FIG. 4
`
`FIG. 5
`
`
`
` 9
`
`
`
`
`
`U.S. Patent
`
`uA
`
`0.8
`
`05m.
`
`US 8,000,782 B2
`
`
`
`
`
`wwcoammmmEBozz«$2st-1.2m
`
`
`
`m:_:E=w$2.5m9oEP-mm...Exmmm025822we:-n.2h
`
`
`
`29m:bfimw-Em
`
`mm...
`
`m.9“.
`
`mNozm
`
`m02m
`
`F02w
`
`N0.2m.
`
`m0.2m
`
`
`
`mmasezmm,035on$2.5m..\
`
`co=m_:E=w
`
`ogw
`
`%Fogm
`
`woamz
`
`10
`
`
`
`10
`
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 6 0131
`
`US 8,000,782 B2
`
`Emsvizltage A
`
`Saturation
`
`Onset 5
`'
`“mesh
`
`FIG. 7
`
`I»
`Stimulation
`Current (mA)
`
`Vthresh
`(100pV)
`
`EMS A
`(W)
`
`
`
`\ \" """"""
`
`T2
`
`""
`
`""""""""""" "
`
`>
`
`5
`
`:
`
`Vpp
`
`Time
`
`T1
`
`'
`
`I Stimulation Artifact Rejection Window
`T1WIN
`
`FIG. 8
`
`
`
`11
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 7 0131
`
`US 8,000,782 B2
`
`FIG. 9
`
`FIG. 10
`
`
`
`12
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 8 0f 31
`
`US 8,000,782 B2
`
`A
`
`..‘L
`
`T2-Vwin
`
`FIG. 11
`
`:Stimulus Pulse
`
`max
`
`FIG. 12
`
`
`
`13
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 9 0131
`
`US 8,000,782 B2
`
`/T1 = 45 ms
`
`Count A
`
`30 _
`
`20 —
`
`10 —
`
`35
`
`40
`
`45
`
`50
`
`D»
`t(ms)
`
`FIG. 13
`
`
`
`14
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 10 0131
`
`US 8,000,782 B2
`
`Vpp
`
`Stimulation Threshold
`to be Found
`
`L v
`
`> Stimulation mA
`
`FIG. 14A
`
`|
`|
`4
`8
`First Bracket T
`
`,
`
`’
`
`1'6
`T
`
`EMG Response - No
`Lower Boundary
`
`EMG Response - Yes
`Upper Boundary
`
`FIG. 14B
`
`4
`8
`Second Bracket I
`
`g 12
`I
`
`16
`
`EMG Response - No i EMG Response - Yes
`Lower Boundary
`Upper Boundary
`
`p I Y
`J
`This Step Repeated Until Bracket Size is S 0.2 mA
`
`I
`
`FIG. 14C
`
`
`
`15
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 11 0131
`
`US 8,000,782 B2
`
`Vpp
`
`l
`2
`
`l
`4
`
`Stimulation Threshoid
`to be Found
`
`C
`
`> Stimulation mA
`
`FIG. 14A
`
`l
`
`l
`
`I
`
`:
`1 I
`5 12
`8
`0.1 mA Increments?
`
`I
`
`Result
`
`D’
`
`I
`16
`
`FIG. 140
`
`I
`2
`
`l
`4
`
`i
`8
`
`EMG Response - No
`Lower Boundary
`
`f
`l
`i
`'
`
`'
`
`i
`
`:
`!12
`I
`-
`
`'
`
`| p
`16
`
`EMG Response - Yes
`Upper Boundary
`
`Switching Between Response and no Response
`
`FIG. 14E
`
`
`
`16
`
`
`
`
`
`U.S. Patent
`
`mS
`
`m
`
`00,
`
`2B2
`
`<E:ozflsEBm
`
`+|||Ol©l|
`
`£25.59;:
`
`N65.20F.9520
`
`uEr.nExofim£5602m
`
`
`
`070m2..9”.
`
`
`
`0,28m8go:”202
`
`8
`
`amomS.Udo.mu_>>
`.ame.
`<EfiowadM4awmyflow.$9.095
`.mci____mates—.22
`
`AllJlllll-filJljnfloonmm2:flmxomLmw_£mEN.8530:_F6::chm,m:wvNma
`
`mczoxufimA.mzcogoaxm
`
`
`
`
`
`:25me
`
`17
`
`
`
`17
`
`
`
`
`
`US. Patent
`US. Patent
`
`Aug. 16, 2011
`Aug. 16, 2011
`
`Sheet 13 0131
`Sheet 13 0131
`
`US 8,000,782 B2
`US 8,000,782 B2
`
`F36.16
`
`m
`w
`
`18
`
`
`
`18
`
`
`
`
`
`US. Patent
`US. Patent
`
`Aug. 16, 2011
`Aug. 16, 2011
`
`Sheet 14 0131
`Sheet 14 0131
`
`US 8,000,782 B2
`US 8,000,782 B2
`
`.2, .0E
`
`FIG.17
`
`19
`
`
`
`19
`
`
`
`
`
`US. Patent
`US. Patent
`
`Aug. 16, 2011
`Aug. 16, 2011
`
`Sheet 15 0131
`Sheet 15 0131
`
`US 8,000,782 B2
`US 8,000,782 B2
`
`FIG.18
`
`FIG. 18
`
`20
`
`
`
`20
`
`
`
`
`
`U.S. Patent
`
`Au .16 2011
`
`Sheet 16 0131
`
`
`
`
`
`21
`
`
`
`
`
`U.S. Patent
`
`Aug. 16, 2011
`
`Sheet 17 of 31
`
`US 8,000,782 B2
`
`AN.0."—
`
`
`I1llxlllll,Q{I'll11%
`
`zofiommfigm._359:02Eon—eat
`
`
`
`
`Lflmhwufla‘“Emma—t.
`
`0901mmmE
`
`22
`
`
`
`22
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 18 0131
`
`US 8,000,782 B2
`
`1
`
`la
`
`:
`
`
`
`lDilatingCannu
`
`(a W.
`10.0mm! .
`“I‘M-MD.”-
`Hmvmuu‘l/I \
`
`mA
`
`THRESHOLD 10
`
`23
`
`DETECTION
`
`FIG.21
`
`.‘L’L
`N
`2L.
`gm
`Eq-
`oa
`mm
`.‘E
`233
`m
`
`ua
`%.
`
`o 2 l
`
`
`
`23
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 19 0131
`
`US 8,000,782 B2
`
`{Eiectrode1}(R,y1)
`
`<31
`
`{Eiectrode 4} (-x1,R) d4
`
`
`
`
`
`
`
`d2 {Eiectrode 2} (101R)
`
`' d3 {Eiectrode 3}(R,-y1)
`
`HG. 22
`
`24
`
`
`
`24
`
`
`
`
`
`U.S. Patent
`
`Aug. 16, 2011
`
`Sheet 20 of 31
`
`US 8,000,782 B2
`
`mic—:9...—mtoufi
`
`MN.9".
`
`25
`
`
`
`25
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 21 0131
`
`US 8,000,782 B2
`
`
`
`.1:
`F-l
`
`m HI”
`NUVASIVE/uM
`
`.
`
`IIII‘MWD 1-.
`Tu.- «‘-(IQ9511‘
`
`FIG.24
`
`
`
`VastusMedialis
`
`'
`
`81
`
`26
`
`ScrewTest
`
`200
`
`100@Stimulation
`
`ma
`
`: E:
`
`u> Eo
`
`.1:
`
`m E
`
`
`
`26
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 22 0131
`
`US 8,000,782 B2
`
`EN
`
`ScrewTest
`
`200
`
`100
`
`U@Stimulation
`
`NUVASIVE
`
`w E
`
`.s:
`|—-
`
`FIG.25
`
`Actual
`
`Baseline
`
`27
`
`Relative
`
`ma
`
`:
`.2w
`
`> EO
`
`.c:
`
`
`
`27
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 23 0131
`
`US 8,000,782 B2
`
`FIG.26
`
`{N
`
`ScrewTest
`
`200
`
`100@Stimulation
`
`Relative
`
`I//
`f/
`It
`f “ifMung“ 1‘
`ruIII
`
`
`
`NUVASIVE
`
`Actual
`
`Baseline
`
`28
`
`.2L
`
`o 5u
`
`.mn
`
`.
`m
`.2
`In
`
`
`
`28
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 24 0131
`
`US 8,000,782 B2
`
`Femoris
`
`RelatiVe
`
`Actual
`
`mA
`
`Baseline 2
`
`> EOJ
`
`:
`U)
`0I-
`.C
`I-
`
`SCréwTest“
`
`100@Stimulation
`
`in
`O
`.2‘5
`
`III
`il‘lil‘nl 'Il air-g
`Mink-VII?“ "
`' ‘*!i0:\\;»—..—.\
`\mt“‘
`”fin.
`
`29
`
`FIG.27
`
`Biceps
`
`
`
`29
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 25 0131
`
`US 8,000,782 B2
`
`EMG
`Vpp
`
`
`
`/' Saturation A
`
`
`
`
`, — r ’ <——— (Threshold)
`
`/- Saturation B
`’—-__
`
`To A:
`Healthy Nerve
`4) Low Threshold
`5) Steep Slope
`6) High Saturation
`
`To B:
`Pathologic Nerve:
`1) Higher Threshold
`2) Lower Slope
`3) Lower Saturation
`
`Stimulation
`mA
`
`FIG. 28
`
`30
`
`
`
`30
`
`
`
`
`
`U.S. Patent
`
`Au .16 2011
`
`Sheet 26 0131
`
`US 8,000,782 B2
`
`mN.0."—
`
`
`
`31
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 27 0131
`
`US 8,000,782 B2
`
`
`
`FIG. 31
`
`32
`
`
`
`32
`
`
`
`
`
`U.S. Patent
`
`US 8,000,782 B2
`
`1gs/mwsm.H,mm?om?2059.35
`M30.6];\13%:m\mImmmrrmagw
`myJuzo:<m:h<m4AHod<EImmmE.4
`fig
`
`2.5.2.5.
`
`
`
`3-5.5.momma.
`
`
`
`20.55.552955.5”.02.
`
`
`
`353:.mamas
`
`NM.9“—
`
`
`
`>OOJOIF¢Em>¢mz
`
`555:5...»®
`llrllaizprmw®
`
`um/
`
`zO_._.<m5H<w
`
`33
`
`
`
`33
`
`
`
`
`
`
`US. Patent
`
`Aug. 16, 2011
`
`Sheet 29 0131
`
`US 8,000,782 B2
`
`34
`
`
`
`3NERVEPATHOLOGY
`
`200
`
`OO‘
`
`—
`
`C
`.2 1a
`
`L“
`3 ,
`.§“
`
`1
`
`W @
`
`a 1'
`1/
`l/
`m r. I f'
`i'mlllMllIMI“ 1‘
`ll‘ill'lll‘ ll 'l-y—u
`
`
`
`NUVASIVE
`
`m
`
`FIG.33
`
`SATURATION MaxVpp (W)
`
`RETRACTION
`
`
`
`VastusMedialis
`
`
`
`34
`
`
`
`
`
`U.S. Patent
`
`6
`
`m
`
`US 8,000,782 B2
`
`mImmmzr
`
`5.5.
`
`2E.
`
`aa>m92m03\‘92m2,20fi<m3<m
`xszOfiEDEm
`o:wmmrr
`myZO_._.<m3h<m4Ammogw4Iwmmxr4
`Eg{g
`
`v”.0."—
`
`m0..._.m0n_
`
`
`
`9:3th932%—
`
`35