1
`
`NUVASIVE 2001
`Medtronic, Inc, v. NuVasive, Inc.
`IPR2013-00504
`
`

`

`US 7,905,840 B2
`
`Page2
`
`U.S. PATENT DOCUMENTS
`
`2,22,62,28 :
`4,235,242 A
`4285 347 A
`4,291,705 A
`j’g‘fi’igg :
`4’519’403 A
`4,545,374 A
`4,561,445 A
`4562 832 A
`4’573’448 A
`4’592’369 A
`4’595’018 A
`4’611’597 A
`4’633’889 A
`4’658’835 A
`4,744,371 A
`4’759’377 A
`4,784,150 A
`4807 642 A
`4’892’105 A
`4’913’134 A
`4’926’865 A
`4’962’766 A
`4,964,411 A
`5007902 A
`5’058’602 A
`5,081,990 A
`5092 344 A
`5,127,403 A
`5,161,533 A
`5171279 A
`5’195’541 A
`5’196’015 A
`113334390 E
`5255’691 A
`5’282’468 A
`5,284,153 A
`5284154 A
`5’299’563 A
`5’312’417 A
`5,313,956 A
`5327 902 A
`5,333,618 A
`5375 067 A
`5’383’876 A
`5’450’845 A
`5’474’558 A
`5’480’440 A
`5’482’038 A
`5,484,437 A
`5’509’893 A
`5’540’235 A
`5’549’656 A
`5’560’372 A
`5’566’678 A
`5’571’149 A
`5’579’781 A
`5’593’429 A
`5,599,279 A
`5 630 813 A
`5’667’508 A
`5,671,752 A
`5707 359 A
`5’711’307 A
`5,728,046 A
`5741253 A
`5,759,159 A
`5’772’661 A
`5,775,331 A
`5,776,144 A
`5,779,642 A
`5,785,658 A
`5,792,044 A
`5,797,854 A
`5,814,073 A
`5,830,151 A
`
`13,1338 Effie?:11'
`11/1980 Howson etal.
`8/1981 Hess
`9/1981 Severinghausetai.
`3,133”; gflrlsttensfnl
`5/1985 Diffihird: 3'
`10/1985 Jacobson
`12/1985 Berke etal.
`1/1986 W'ld
`1
`”986 K1 3“”
`6/1986 Dan} ”‘31
`6/1986 R3151“
`'
`9/1986 Kr ”“1
`“1987 “31:15
`4/1987 ngndlorf
`5/1988 Harris
`7/1988 Dykstm
`11/1988 Voorhiesetal.
`2/1989 B
`“1990 Frown
`4/1990 Lmss
`5/1990 quue
`10/1990 H2311
`10/1990 Johnson etal.
`4991 Wm
`10/1991 Brlody
`1/1992 Deletis
`3/1992 Lee
`7/1992 Brownlee
`11/1992 Prassetal.
`”/1992 Mth
`”993 01:1
`e‘fi’s.
`”993 N 63° 3““
`9/1993 C611 m t
`10/1993 03“”
`2/1994 Kleiflnski
`2/1994 Raymondetal.
`2/1994 Ra
`d t
`1
`4994 s WHO“
`8 3'
`5/1994 Via“
`5/1994 Knutsson etal.
`7/1994 Lemmen
`8/1994 Lekhtman etal.
`”/1994 B
`h.
`“1995 N“: 111‘
`9/1995 Afle ad
`”/1995 N efaadrt
`“1996 Kent?
`“1996 R“; ”1
`1/1996 M1, hl
`4/1996 P” “on
`7/1996 “films
`8/1996 R1.”
`10/1996 C3155
`10/1996 C33?”e11
`1
`11/1996 L'
`”/1996 C‘sslfta'
`“1997 R303?“
`2/1997 Slotman etal.
`5/1997 K.
`ah
`9/1997 Erlfitcugetzl
`9/1997 Sinderby etal.
`1/1998 B fal'
`.
`“1998 Sims“
`3/1998 Mayer etal.
`4/1998 Michelson
`6/1998 Masreliez
`6/1998 Michelson
`7/1998 Raymond etal.
`7/1998 Leysiefferetal.
`7/1998 Nightengale
`7/1998 Benaron et al.
`8/1998 Foley etal.
`8/1998 Hedgecock
`9/1998 Bonutti
`11/1998 Hadzic etal.
`
`5,851,191 A
`5,853,373 A
`5,860,973 A
`5’862’314 A
`5,872,314 A
`2333333 2
`5,891,147 A
`5,902,231 A
`233333 2
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`5,935,131 A
`5,938,688 A
`5,944,658 A
`5,976,094 A
`6,004,262 A
`6,027,456 A
`6,038,469 A
`6’038’477 A
`6,050,992 A
`6’074’343 A
`6,104,957 A
`6,104,960 A
`6,120,503 A
`6,126,660 A
`6,132,386 A
`6’132’387 A
`6,135,965 A
`6,139,493 A
`6’146’335 A
`6,152,871 A
`232132: $1
`’
`’
`6,206,826 B1
`6,224,549 B1
`6,259,945 B1
`6,266,558 B1
`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
`6,425,859 B1
`6’425’901 B1
`6,451,015 B1
`6,466,817 B1
`6,468,205 B1
`6,468,207 B1
`6,500,128 B2
`6,524,320 B2
`6,535,759 B1
`6,564,078 B1
`6,579,244 B2
`6,620,157 B1
`6,719,692 B2
`6,760,616 B2
`6,796,985 B2
`6,810,281 B2
`6,819,956 B2
`6’847’849 B2
`6,849,047 B2
`6,855,105 B2
`6’902’569 B2
`6,926,728 B2
`6,929,606 B2
`6’945’933 B2
`7,047,082 B1
`7’050’848 BZ
`7,079,883 B2
`79895059 Bl
`7,177a677 32
`7,207,949 B2
`7,261,688 BZ
`7,582,058 B1
`2001/0039949 A1
`2001/0056280 A1
`2002/0007129 A1
`
`............. 606/79
`
`12/1998 Gozani
`12/1998 Griffith etal.
`1/1999 Michelson
`“1999 Jeddeth
`2/1999 C11nton
`3,3333 gig?“
`4/1999 Moskovitz etal.
`5/1999 Foleyetal.
`3,1333 Efsiisdes
`.
`8/1999 Bonuttletal.
`8/1999 Schiff
`8/1999 Korosetal.
`11/1999 Gozanietal.
`12/1999 Putzetal.
`2/2000 Feleretal.
`3/2000 Karlsson etal.
`”000 Kayyah
`4/2000 Nichols
`“000 Nathanson et 31'
`8/2000 A1o etal.
`8/2000 Duysensetal.
`9/2000 Michelson
`10/2000 Dietz
`10/2000 Gozanietai.
`10/2000 Gozametal'
`10/2000 Tumeretal.
`10/2000 Korosetai.
`“/2000 Gown
`11/2000 Foleyetal.
`13,388? Eng et 31'
`“155
`3/2001 Mathewsetal.
`5/2001 Drongelen
`7/2001 Epstein etal.
`7/2001 Gozanietal.
`8/2001 Streeter
`9/2001 Prassetal.
`10/2001 PM”
`10/2001 Shaw ............................ 128/869
`11/2001 Herzon
`12/2001 Griffithetal.
`”/2001 HaCker
`7/2002 Foleyetal.
`”002 21.1“ et 31'
`9/2002 R1ttman,IHetal.
`10/2002 Kaulaetal.
`10/2002 Mollenaueretal.
`10/2002 Fowler, Jr.
`12/2002 Marino
`2/2003 DiPoto
`3/2003 Epstein etal.
`5/2003 Marino etal.
`6/2003 Goodwin
`9/2003 Dabneyetal.
`4/2004 Kleffneretal.
`7/2004 Hoeyetal.
`9/2004 Bolgeretal.
`10/2004 Brocketal.
`11/2004 DiLorenzo
`“2005 Mam" 331'
`2/2005 Goodwm
`2/2005 Jackson, IIIetal.
`“005 Farmer et 31'
`8/2005 Zucherman etal.
`8/2005 Rjtland
`”005 Brmh
`5/2006 Schrometal.
`”006 Hoey et 31'
`7/2006 Marino etal.
`”006 P1855
`”007 Kéula etaL
`4/2007 M11_eseta1.
`8/2007 Smlth et al.
`9/2009 Miles et 31.
`11/2001 Loubser
`12/2001 Underwood etal.
`1/2002 Marino
`
`.......... 600/201
`
` 2
`
`

`

`US 7,905,840 B2
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`Page 3
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`.............. 606/190
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`1/2002 Desai
`2002/0010392 A1
`2002/0072686 A1
`6/2002 Hoey et al.
`9/2002 Grill et a1.
`2002/0123780 A1
`10/2002 Cohen et a1.
`2002/0161415 A1
`12/2002 Hill et al.
`2002/0193843 A1
`2003/0032966 A1
`2/2003 Foley et a1.
`6/2003 Marino
`2003/0105503 A1
`8/2003 Clifton
`2003/0149341 A1
`12/2003 Weiner
`2003/0225405 A1
`2003/0236544 A1* 12/2003 Lunsford et a1.
`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 a1.
`2005/0033380 A1
`2/2005 Tanner et al.
`2005/0075578 A1
`4/2005 Gharib et al.
`2005/0149035 A1
`7/2005 Pimenta et al.
`2005/0182454 A1
`8/2005 Gharib et al.
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`2006/0025703 A1
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`2006/0052828 A1
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`3/2006 Miles et a1.
`2006/0224078 A1
`10/2006 Hoey et al.
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`3/2008 Kelleher et al.
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`
`EP
`FR
`WO
`W0
`WO
`WO
`W0
`W0
`W0
`WO
`WO
`W0
`WO
`W0
`
`FOREIGN PATENT DOCUMENTS
`0972538 A2
`1/2000
`2 795 624
`1/2001
`WO-0038574 A1
`7/2000
`WO 00/67645
`11/2000
`WO-0066217 A1
`11/2000
`WO-0137728 A1
`5/2001
`W0 02/054960
`7/2002
`W0 03/005887
`1/2003
`W0 03/026482
`4/2003
`WO-03037170 A3
`5/2003
`WO-2005013805 A3
`2/2005
`WO 2005/030318
`4/2005
`WO-2006042241 A2
`4/2006
`WO 2006/066217
`6/2006
`
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`METRX Delivered Order Form, 1999, 13 pages.
`Medtronic Sofamor Danek “METRXTM MicroDisectomy System,”
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`Medtronic Sofamor Danek “METRX System Surgical Technique,”
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`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.
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`Dec. 3, 1997, 464 pages.
`Foley and Smith, “Microendoscopic Discectomy,” Techniques in
`Neurosurgery, 1997, 3(4):301-307.
`VIedtronic Sofamor Danek “UnionTM / Union-LTM Anterior & Lateral
`Impacted Fusion Devices: Clear choice of stabilization,” Medtronic
`Sofamor Danek, 2000, 4 pages.
`\IuVasive VectorTM Cannulae, 1 page (prior to Sep. 25, 2003).
`\IuVasive TriadTM Tri-Columnar Spinal EndoArthrodesisTM via
`VIinimally Invasive Guidance, 1 page (prior to Sep. 25, 2003).
`\IuVasive TriadTM Cortical Bone Allograft, 1 page (prior to Sep. 25,
`2003).
`\IuVasive Vertebral Body Access System, 1 page (prior to Sep. 25,
`2003).
`VIarina, “New Technology for Guided Navigation with Real Time
`\Ierve Surveillance for Minimally Invasive Spine Discectomy &
`Arthrodesis,” Spineline, 2000, p. 39.
`\IuVasive “INS-1 Screw Test,” 2001, 10 pages.
`\IuVasive letter re 510k Neuro Vision JJB System, Oct. 16, 2001, 5
`pages.
`\IuVasive letter re 510k Guided Arthroscopy System, Oct. 5, 1999, 6
`pages.
`\IuVasive 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.
`\IuVasive letter re: 510(k) for Neurovision JJB System (Summary),
`Sep. 25, 2001, 28 pages.
`\IuVasive letter re: Special 510(k) Premarket Notification: Neurovi-
`sion JJB System (Device Description), Jul. 3, 2003, 18 pages.
`\IuVasive letter re: Special 510(k) Premarket Notification: Neurovi-
`sion JJB System (Device Description), Mar. 1, 2004, 16 pages.
`\IuVasive letter re: Special 510(k) Premarket Notification: Neurovi-
`sion JJB System (Device Description), May 26, 2005, 17 pages.
`\IuVasive letter re: 510(k) Premarket Notification: Neurovision JJB
`System (Device Description), Jun. 24, 2005, 16 pages.
`\IuVasive letter re: Special 510(k) Premarket Notification: Neurovi-
`sion JJB System (Device Description), Sep. 14, 2006, 17 pages.
`\IuVasive 510(k) Premarket Notification: Neurovision JJB System
`(Device Description), Aug. 20, 2007, 8 pages.
`\IuVasive letter re: 510(k) Premarket Notification: Guided Spinal
`Arthroscopy System (Device Description), Feb. 1, 1999, 40 pages.
`\IuVasive 510(k) Premarket Notification: Spinal System (Summary),
`Apr. 12,2004, 10 pages.
`\IuVasive 510(k) Summary NIM Monitor, Sep. 4, 1998, 4 pages.
`\IuVasive correspondence re 510(k) Premarket Notification INS-1
`Intraoperative Nerve Surveillance System: Section IV Device
`Description, pp. 12-51 (prior to Sep. 25, 2003).
`\IuVasive letter re 510(k) Premarket Notification 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 ofElectroneurodagnostic 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 Electrified Pedicle Stimulation Instruments
`in Spinal Instrumentation: Techniques and Protocol Development,”
`Spine, 1997, 22(3): 334-343.
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`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.
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` 3
`
`

`

`US 7,905,840 B2
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`Page 4
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`Dezawa et al., “Retroperitoneal Laparoscopic Lateral Approach to
`the Lumbar Spine: A New Approach, Technique, and Clinical Trial,”
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`minimal invasive reconstruction of the anterior column of the tho-
`racic and lumbar spine,” Eur Spine J, 2001, 10: 396-402.
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`US. Patent
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`Mar. 15, 2011
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`Sheet 1 0150
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`FIG. 1
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`FIG. 2
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`US. Patent
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`FIG. 3
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` 8
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`U.S. Patent
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`Mar. 15 2011
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`Sheet4 of 50
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`FIG. 5
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`10
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`U.S. Patent
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`Mar. 15, 2011
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`FIG. 7
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`14
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`US. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`17
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`17
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`US 7,905,840 B2
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`US. Patent
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`Mar. 15, 2011
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`U.S. Patent
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`US. Patent
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`US. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`Mar. 15, 2011
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`U.S. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`US. Patent
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`US. Patent
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`Mar. 15, 2011
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`Sheet 37 0f 50
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`Mar. 15, 2011
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`US. Patent
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`US. Patent
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`Mar. 15, 2011
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`US 7,905,840 B2
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`US. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`Sheet 44 0f 50
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`US 7,905,840 B2
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`FIG.44
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`US. Patent
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`Mar. 15, 2011
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`Sheet 45 0f 50
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`US 7,905,840 B2
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`U.S. Patent
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`Mar. 15, 2011
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`US. Patent
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`Mar. 15, 2011
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`Sheet 47 0f 50
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`US. Patent
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`Mar. 15, 2011
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`53
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`US. Patent
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`Mar. 15, 2011
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`215
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`280
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`54
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`US. Patent
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`Mar. 15, 2011
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`FIG. 50
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`55
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`55
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`US 7,905,840 B2
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`1
`SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`The present application claims the benefit of priority from
`commonly owned and co-pending US. Provisional Patent
`Application Ser. No. 60/512,594 (filed on Oct. 17, 2003 by
`Curran et al.) entitled “System and Methods for Performing
`Lateral Lumbar Surgery,” the entire contents of which is
`hereby expressly incorporated by reference into this disclo-
`sure as if set forth fully herein. The present application also
`incorporates by reference the following co-pending and 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 Dur-
`ing Surgery,” filed on Jul. 1 1, 2002; PCT App. Ser. No. PCT/
`USO2/30617, entitled “System and Methods for Performing
`Surgical Procedures and Assessments,” filed on Sep. 25,
`2002; PCT App. Ser. No. PCT/U802/35047, entitled “System
`and Methods for Performing Percutaneous Pedicle Integrity
`Assessments,” filed on Oct. 30, 2002; and PCT App. Ser. No.
`PCT/U803/02056, entitled “System and Methods for Deter-
`mining Nerve Direction to a Surgical Instrument,” filed Jan.
`15, 2003 (collectively “NeuroVision PCT Applications”).
`
`BACKGROUND OF THE INVENTION
`
`I. Field of the Invention
`
`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. Discussion of the PriorArt
`
`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 substantially smaller size with greatly reduced tissue
`displacement requirements. This, in turn, reduces the pain,
`morbidity and cost associated with such procedures. The
`access systems developed to date, however, fail in various
`respects to meet all the needs of the surgeon population.
`One drawback associated with prior art surgical access
`systems relates to the ease with which the operative corridor
`can be created, as well as maintained over time, depending
`upon the particular surgical target site. For example, when
`accessing surgical target sites located beneath or behind mus-
`culature or other relatively strong tissue (such as, by way of
`example only, the psoas muscle adjacent to the spine), it has
`been found that advancing an operative corridor-establishing
`instrument directly through such tissues can be challenging
`and/or lead to unwanted or undesirable effects (such as stress-
`ing or tearing the tissues). While certain efforts have been
`undertaken to reduce the trauma to tissue while creating an
`operative corridor, such as (by way of example only) the
`sequential dilation system ofUS. Pat. No. 5,792,044 to Foley
`et al., these attempts are nonetheless limited in their applica-
`
`2
`
`bility based on the relatively narrow operative corridor. More
`specifically, based on the generally cylindrical nature of the
`so-called “working cannula,” the degree to which instruments
`can be manipulated and/or angled within the cannula can be
`generally limited or restrictive, particularly if the surgical
`target site is a relatively deep within the patient.
`Efforts have been undertaken to overcome this drawback,
`such as shown in US. Pat. No. 6,524,320 to DiPoto, wherein
`an expandable portion is provided at the distal end of a can-
`nula for creating a region of increased cross-sectional area
`adjacent to the surgical target site. While this system may
`provide for improved instrument manipulation relative to
`sequential dilation access systems (at least at deep sites
`within the patient), it is nonetheless flawed in that the deploy-
`ment of the expandable portion may inadvertently compress
`or impinge upon sensitive tissues adjacent to the surgical
`target site. For example, in anatomical regions having neural
`and/or vasculature structures, such a blind expansion may
`cause the expandable portion to impinge upon these sensitive
`tissues and cause neural and/or vasculature compromise,
`damage and/or pain for the patient.
`This highlights yet another drawback with the prior art
`surgical access systems, namely, the challenges in establish-
`ing an operative corridor through or near tissue having major
`neural structures which, if contacted or impinged, may result
`in neural impairment for the patient. Due to the threat of
`contacting such neural structures, efforts thus far have largely
`restricted to establishing operative corridors through tissue
`having little or substantially reduced neural structures, which
`effectively limits the number of ways a given surgical target
`site can be accessed. This can be seen, by way of example
`only, in the spinal arts, where the exiting nerve roots and
`neural plexus structures in the psoas muscle have rendered a
`lateral or far lateral access path (so-called trans-psoas
`approach) to the lumbar spine virtually impossible. Instead,
`spine surgeons are largely restricted to accessing the spine
`from the posterior (to perform, among other procedures, pos-
`terior lumbar interbody fusion (PLIF)) or from the anterior (to
`perform, among other procedures, anterior lumbar interbody
`fusion (ALIF)).
`Posterior-access procedures involve traversing a shorter
`distance within the patient to establish the operative corridor,
`albeit at the price of oftentimes having to reduce or cut away
`part of the posterior bony structures (i.e.
`lamina, facets,
`spinous process) in order to reach the target site (which typi-
`cally comprises the disc space). Anterior-access procedures
`are relatively simple for surgeons in that they do not involve
`reducing or cutting away bony structures to reach the surgical
`target site. However, they are nonetheless disadvantageous in
`that they require traversing through a much greater distance
`within the patient to establish the operative corridor, often-
`times requiring an additional surgeon to assist with moving
`the various internal organs out of the way to create the opera-
`tive corridor.
`
`The present invention is directed at eliminating, or at least
`minimizing the effects of, the above-identified drawbacks in
`the prior art.
`
`SUMMARY OF THE INVENTION
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`The present invention accomplishes this goal by providing
`a novel access system and related methods which involve
`detecting the existence of (and optionally the distance and/or
`direction to) neural structures before, during, and after the
`establishment of an operative corridor through (or near) any
`of a variety of tissues having such neural structures which, if
`contacted or impinged, may otherwise result in neural impair-
`56
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`
`56
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`

`US 7,905,840 B2
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`3
`ment for the patient. It is expressly noted that, although
`described h