(12) Ulllted States Patent
`Pimenta et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,905,840 B2
`Mar. 15, 2011
`
`US007905840B2
`
`(54) SURGICAL ACCESS SYSTEM AND RELATED
`
`_
`_
`_
`(75) Inventors: Lulz Plmenta, Sao Paulo (BR); Patrick
`Miles, San Diego, CA (US); Scot
`-
`-
`'
`.
`giaftmeslh’ SSH D12: CUASGJS)’ Em
`111 9y, an 1980,
`(
`)
`_
`_
`_
`(73) Ass1gnee: NuVaslve, Inc., San D1ego, CA (US)
`
`-
`
`2,808,826 A 10/ 1957 Reinef 6t a1~
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`(Continued)
`
`( * ) Notice:
`
`Subject' to any disclaimer,~ the term of this
`patent 1s extended or adjusted under 35
`U.S.C. 154(b) by 1803 days.
`
`DE
`
`FOREIGN PATENT DOCUMENTS
`
`7/1999
`299 08 259
`(Continued)
`
`(21) App1.No.: 10/967,668
`
`(22) Filed:
`
`Oct‘ 18’ 2004
`
`(65)
`
`Prior Publication Data
`
`US 2005/0149035 A1
`
`Jul. 7, 2005
`
`OTHER PUBLICATIONS
`Anatomy of the Lumbar Spine in MED TM MicroEndoscopic
`Discectomy (1997 Ludann Grand Rapids MI), 14 pgs.
`(Continued)
`
`t_ D t
`R l t dUs A l_
`e a e
`'
`' PP lea Ion a a
`(60) Provisional application No. 60/512,594, ?led on Oct.
`17, 2003-
`
`Primary ExamineriMax Hindenburg
`Assistant Examiner * Fangemonique Smith
`(74) Azwrney, Agenz, or Firm ilonathan Spangler; Rory
`Scherrnerhom; Fish & Richardson PC.
`
`(51) Int. Cl.
`A61B 5/05
`
`(200601)
`
`ABSTRACT
`(57)
`A surgical access system including a tissue distraction assem
`
`~ ~ ~ ~ ~ ~ ...- ~ ~ ~ ~ ~ ~ --. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ .
`
`(58) Field of Classi?cation Search ................ .. 600/545,
`_
`_
`600/546’ 547’ 554’ 210’ 221
`See apphcanon ?le for Complete Search hlstory-
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`a 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.
`
`30 Claims, 50 Drawing Sheets
`
`
`
` 1
`
`NUVASIVE 1059
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`
`

`

`US 7,905,840 B2
`Page2
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`
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` 2
`
`

`

`US 7,905,840 B2
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`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.
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`
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`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.
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`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.
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`Description, pp. 12-51 (prior to Sep. 25, 2003).
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`tive Nerve Surveillance System, Aug. 24, 2000, 81 pages.
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`
`
`
` 3
`
`

`

`US 7,905,840 B2
`Page 4
`
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`cal progression moves spine surgery forward,” AAOS Now, 2009, 5
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`thoracolumbar surgery,” Eur Spine J., 2000, 9(1): S30-S34.
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`minimal invasive reconstruction of the anterior column of the tho
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`Neurosurgery, 2002, 51(2): 159-165.
`McAfee et al., “Minimally Invasive Anterior Retroperitoneal
`Approach to the Lumbar Spine: Emphasis on the Lateral BAK,”
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`lumbar spine using the retroperitoneal approach,” J'. Neurosurg
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`titanium threaded fusion cages,” J'. Neurosurg (Spine 1), 2002, 96:
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`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 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,”
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`Rao, et al. “Dynamic retraction of the psoas muscle to expose the
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`

`

`US. Patent
`US. Patent
`
`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 1 0150
`Sheet 1 0150
`
`US 7,905,840 B2
`US 7,905,840 B2
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`
`
`FIG. 1
`FIG. 1
`
`
`
` 6
`
`

`

`US. Patent
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`Mar. 15,2011
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`Sheet 2 0f50
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`US 7,905,840 B2
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`FIG. 2
`
`
`
` 7
`
`

`

`US. Patent
`US. Patent
`
`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 3 0f 50
`Sheet 3 0f 50
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`US 7,905,840 B2
`US 7,905,840 B2
`
`
`
`FIG. 3
`FIG. 3
`
`
`
` 8
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`

`

`U.S. Patent
`US. Patent
`
`Mar. 15 2011
`Mar. 15, 2011
`
`Sheet4 of 50
`Sheet 4 0f 50
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`US 7,905,840 B2
`
`
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`FIG. 4
`FIG. 4
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` 9
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`

`

`US. Patent
`US. Patent
`
`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 5 0f 50
`Sheet 5 0f 50
`
`US 7,905,840 B2
`US 7,905,840 B2
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`
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`FIG. 5
`
`10
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`

`US. Patent
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`Mar. 15, 2011
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`Sheet 6 0f 50
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`US 7,905,840 B2
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`
`
`FIG. 6
`
`
`
`11
`
`

`

`U.S. Patent
`US. Patent
`
`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 7 0f 50
`Sheet 7 of 50
`
`US 7,905,840 B2
`US 7,905,840 B2
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`
`
`FIG. 7
`FIG. 7
`
`
`
`12
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`

`

`US. Patent
`US. Patent
`
`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 8 0f 50
`Sheet 8 0f 50
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`US 7,905,840 B2
`US 7,905,840 B2
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`
`
`FIG. 8
`FIG. 8
`
`13
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`13
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`

`

`US. Patent
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`Mar. 15, 2011
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`Sheet 9 0f 50
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`US 7,905,840 B2
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`46
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`

`US. Patent
`US. Patent
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`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 10 0f 50
`Sheet 10 0f 50
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`US 7,905,840 B2
`US 7,905,840 B2
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`15
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`15
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`

`

`US. Patent
`US. Patent
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`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 11 0150
`Sheet 11 0150
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`US 7,905,840 B2
`US 7,905,840 B2
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`

`US. Patent
`US. Patent
`
`Mar. 15, 2011
`Mar. 15, 2011
`
`Sheet 12 0150
`Sheet 12 0150
`
`US 7,905,840 B2
`US 7,905,840 B2
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`39
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`

`US. Patent
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`Mar. 15, 2011
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`Sheet 13 0f 50
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`US 7,905,840 B2
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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 15 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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`Sheet 16 of 50
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`US. Patent
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`Mar. 15, 2011
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`Sheet 17 0150
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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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`Sheet 18 0f 50
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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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`Sheet 19 0150
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`US 7,905,840 B2
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`120
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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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`Sheet 21 0150
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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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`Sheet 22 of 50
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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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`Sheet 23 0f 50
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`US 7,905,840 B2
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`OON
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`28
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`

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`US. Patent
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`Mar. 15, 2011
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`Sheet 24 0f 50
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`US 7,905,840 B2
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`FIG. 24
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`29
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`Mar. 15, 2011
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`Sheet 25 0f 50
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`US 7,905,840 B2
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`30
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`U.S. Patent
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`Mar. 15, 2011
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`Sheet 27 0f 50
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`US 7,905,840 B2
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`FIG. 27
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`
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`US. Patent
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`Mar. 15, 2011
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`Sheet 28 0f 50
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`US 7,905,840 B2
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`200
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`33
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`Mar. 15, 2011
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`Sheet 29 0f 50
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`US 7,905,840 B2
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`206
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`Sheet 30 0f 50
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`220
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`Sheet 31 0f 50
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`US 7,905,840 B2
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`275
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`Sheet 32 0f 50
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`US 7,905,840 B2
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`214
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`220
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`Mar. 15, 2011
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`Sheet 33 0f 50
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`US 7,905,840 B2
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`FIG.33
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`38
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`Mar. 15, 2011
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`39
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`39
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`US. Patent
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`Mar. 15, 2011
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`Sheet 35 0f 50
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`US 7,905,840 B2
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`Mar. 15, 2011
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`Sheet 36 0f 50
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`US 7,905,840 B2
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`41
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`41
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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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`US 7,905,840 B2
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`US. Patent
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`Mar. 15, 2011
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`Sheet 38 0f 50
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`US 7,905,840 B2
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`43
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`Mar. 15, 2011
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`US 7,905,840 B2
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`41
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`220
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`Mar. 15, 2011
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`Sheet 40 0f 50
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`US 7,905,840 B2
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`FIG.40
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`45
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`US. Patent
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`Mar. 15, 2011
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`Sheet 41 0f 50
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`US 7,905,840 B2
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`206
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`220
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`46
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`US. Patent
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`Mar. 15, 2011
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`Sheet 42 0f 50
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`US 7,905,840 B2
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`

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`US 7,905,840 B2
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`FIG.43
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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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`49
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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
`
`Rdar.15,2011
`
`Sheet460f50
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`US 7,905,840 132
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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 7,905,840 B2
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`215
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`52
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`
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`52
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`Mar. 15, 2011
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`53
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`53
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`US. Patent
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`Mar. 15, 2011
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`Sheet 49 0f 50
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`215
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`280
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`206
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`282
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`54
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`
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`54
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`

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`US. Patent
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`Mar. 15, 2011
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`Sheet 50 0f 50
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`US 7,905,840 B2
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`
`
`FIG. 50
`
`55
`
`
`
`55
`
`

`

`US 7,905,840 B2
`
`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 undesir