(12) United States Patent
`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
`
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`21956
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`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
`
`

`

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`
`
` 3
`
`
`
`

`

`US 8,000,782 B2
`Page 4
`
`Plaintiffs’ Supplemental Preliminary Invalidity Contentions-Appen
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`
`
` 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
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`
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`

`U.S. Patent
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`US. Patent
`
`Aug. 16, 2011
`
`Sheet 4 0131
`
`US 8,000,782 B2
`
`Stim
`Current *
`
`ZOOPS
`
`/ ISTIM
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`EMG
`Voltage
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`Time
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`FIG. 4
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`FIG. 5
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`

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`U.S. Patent
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`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)
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`T1WIN
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`FIG. 8
`
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`11
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`
`

`

`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
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`
`
`

`

`US. Patent
`
`Aug. 16, 2011
`
`Sheet 9 0131
`
`US 8,000,782 B2
`
`/T1 = 45 ms
`
`Count A
`
`30 _
`
`20 —
`
`10 —
`
`35
`
`40
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`45
`
`50
`
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`
`FIG. 13
`
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`14
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`

`

`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
`
`,
`
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`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
`
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`
`

`

`US. Patent
`
`Aug. 16, 2011
`
`Sheet 11 0131
`
`US 8,000,782 B2
`
`Vpp
`
`l
`2
`
`l
`4
`
`Stimulation Threshoid
`to be Found
`
`C
`
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`
`FIG. 14A
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`l
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`l
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`Upper Boundary
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`Switching Between Response and no Response
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`FIG. 14E
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`16
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`
`

`

`U.S. Patent
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`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
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`US. Patent
`US. Patent
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`Aug. 16, 2011
`Aug. 16, 2011
`
`Sheet 14 0131
`Sheet 14 0131
`
`US 8,000,782 B2
`US 8,000,782 B2
`
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`

`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
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`FIG. 18
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`20
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`U.S. Patent
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`Au .16 2011
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`Sheet 16 0131
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`21
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`U.S. Patent
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`Aug. 16, 2011
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`Sheet 17 of 31
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`US 8,000,782 B2
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`US. Patent
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`Aug. 16, 2011
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`Sheet 18 0131
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`US 8,000,782 B2
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`US. Patent
`
`Aug. 16, 2011
`
`Sheet 19 0131
`
`US 8,000,782 B2
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`U.S. Patent
`
`Aug. 16, 2011
`
`Sheet 20 of 31
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`US 8,000,782 B2
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`25
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`

`

`US. Patent
`
`Aug. 16, 2011
`
`Sheet 21 0131
`
`US 8,000,782 B2
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`US. Patent
`
`Aug. 16, 2011
`
`Sheet 22 0131
`
`US 8,000,782 B2
`
`EN
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`ScrewTest
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`US. Patent
`
`Aug. 16, 2011
`
`Sheet 23 0131
`
`US 8,000,782 B2
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`FIG.26
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`US. Patent
`
`Aug. 16, 2011
`
`Sheet 24 0131
`
`US 8,000,782 B2
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`Femoris
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`US. Patent
`
`Aug. 16, 2011
`
`Sheet 25 0131
`
`US 8,000,782 B2
`
`EMG
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`FIG. 28
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`30
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`

`U.S. Patent
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`Au .16 2011
`
`Sheet 26 0131
`
`US 8,000,782 B2
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`mN.0."—
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`31
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`

`US. Patent
`
`Aug. 16, 2011
`
`Sheet 27 0131
`
`US 8,000,782 B2
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`
`
`FIG. 31
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`32
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`

`U.S. Patent
`
`US 8,000,782 B2
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`US. Patent
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`Aug. 16, 2011
`
`Sheet 29 0131
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`US 8,000,782 B2
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`34
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`U.S. Patent
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`6
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