US008005535B2
`
`(12) Ulllted States Patent
`Gharib et a].
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,005,535 B2
`Aug. 23, 2011
`
`(54) SYSTEM AND METHODS FOR
`PERFORMING SURGICAL PROCEDURES
`AND ASSESSMENTS
`
`.
`(75) Inventors: James Gharib, San D1ego, CA (US);
`Allen Farquhar, San D1ego, CA (US);
`Norbert F. Kaula, Arvada, CO (US);
`Jeffrey J. BleWett, San Diego, CA (US);
`Goretti Medeiros, legal representative,
`Plantsville’ CT (Us); Eric Finley’
`PoWay, CA (US); Jamil Elbanna, San
`Diego, CA (US); Scot Martinelli,
`Mountain Top, PA (US)
`
`(56)
`
`References Cited
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`
`(Continued)
`
`65
`(
`)
`
`P bl' t' D t
`P '
`nor u lea Ion a a
`Us 2009/0192403 A1
`1111' 30’ 2009
`
`Primary Examiner * Max Hindenburg
`Assistant Examiner * Jonathan M Foreman
`
`Related U 5 Application Data
`
`(74) Attorney, Agent, or Firm * Fish & Richardson PC.
`
`(63) Continuation of application No. 10/ 809,280, ?led on
`Mar. 25, 2004, noW Pat. No. 7,522,953, Which is a
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`(51) Int_ CL
`(2006.01)
`A61B 5/04
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`-
`-
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`(58) Field of Classi?cation Search ................ .. 600/546,
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`623/17. 1 1
`See application ?le for complete search history.
`
`(57)
`
`ABSTRACT
`
`The present invention involves systems and related methods
`for performing surgical procedures and assessments, includ
`mg the. use of neurophyslology_based .mOImOnng to: .(a)
`determ1ne nerve prox1m1ty and nerve direction to surg1cal
`instruments employed in accessing a surgical target site; (b)
`assess the pathology (health or status) of a nerve or nerve root
`before, durin , or after a sur ical rocedure; and/or c assess
`8
`g
`P
`Pedicle integn'ty before, during Or after Pedicle Screw Place
`ment, all in an automated, eas to use, and eas to inte ret
`_
`_
`y
`_
`y
`rp
`fash1on so as to prov1de a surgeon-driven system.
`
`12 Claims, 31 Drawing Sheets
`
`
`
` 1
`
`NUVASIVE 1062
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

`

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` 4
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`
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`
`
` 5
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 1 0131
`
`US 8,005,535 B2
`
`10\
`
`Stimulating One or More Electrodes on
`a 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
`
`16\
`
`Communicating the Relationship
`Between the Surgical Accessory and
`the Nerve to the User
`
`FIG. 1
`
`
`
` 6
`
`
`
`

`

`US. Patent
`US. Patent
`
`Aug. 23, 2011
`Aug. 23, 2011
`
`Sheet 2 0f 31
`Sheet 2 0f 31
`
`US 8,005,535 B2
`US 8,005,535 B2
`
`27
`
`W
`
`27
`
`27
`
`29
`
`
`
`/22
`44
`
`42
`
`FIG. 2
`FIG. 2
`
`
`
` 7
`
`
`
`

`

`U.S. Patent
`
`Aug. 23, 2011
`
`Sheet 3 of 31
`
`US 8,005,535 B2
`
`O_>_m_
`m_om:_>_ E23;
`
`wm
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`vam
`
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`8:80
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` 8
`
`
`
`
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 4 0f 31
`
`US 8,005,535 B2
`
`Stim A
`Current
`
`ZOOHS
`
`/ lsT||\/|
`
`FIG. 4
`
`EMG A
`Voltage
`
`vmax
`
`FIG. 5
`
`>
`Time
`
`Time
`
`
`
` 9
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`uA
`Aug. 23, 2011
`g
`
`Sheet 5 0f 31
`5m«M
`M
`
`US 8,005,535 B2
`US 8,005,535 B2
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`
`
`
`
`wwcoqwmm9582259505-1.2m
`
`N._.xmemafimoz29:2.-Qz._.
`
`
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`m:_:E=m522mm2mg_._.-m:.
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`r
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`5.55.5
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`2%
`26
`
`$562
`$502
`
`10
`
`
`
`10
`
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 6 0f 31
`
`US 8,005,535 B2
`
`EMGV\g:tage A
`
`Saturation
`
`Vthresh
`(100W)
`
`Onset '
`
`Ithresh
`
`FIG. 7
`
`P
`
`Stimulation
`Current (mA)
`
`EMG A
`(W)
`
`\
`
`T2
`
`_a
`
`\ _______
`
`____
`
`____________ n _
`
`T1
`
`I Stimulation Artifact Rejection Window
`T1WIN
`
`FIG. 8
`
`
`
`11
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 7 0f 31
`
`US 8,005,535 B2
`
`FIG. 9
`
`FIG. 10
`
`
`
`12
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 8 0f 31
`
`US 8,005,535 B2
`
`TZ-VWin
`
`FIG. 11
`
`:Stimulus Pulse
`
`max
`
`ll
`
`1
`
`FIG. 12
`
`
`
`13
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 9 0f 31
`
`US 8,005,535 B2
`
`/T1 = 45 ms
`
`Count A
`
`30 _
`
`20 —
`
`10 —
`
`35
`
`40
`
`45
`
`50
`
`P
`urns)
`
`FIG. 13
`
`
`
`14
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 10 0f 31
`
`US 8,005,535 B2
`
`Vpp
`
`.m S
`
`.nsllmb Mm
`
`WW
`
`m 0 m mm
`0e
`nF C- ............. -
`
`.m
`A m n
`a A M 4 m 1 w m > F
`
`|
`4
`First Bracket
`
`G0
`ML E
`
`%d
`
`0U 0.0
`nn
`SB
`.w
`
`E
`
`er Re W mu
`ed Sn mw
`$5
`
`% Yw
`
`.a
`FIG. 14B
`
`Second Bracket
`
`EMG Response - No
`Lower Boundary
`
`EMG Response - Yes
`Upper Boundary
`
`This Step Repeated Until Bracket Size is S 0.2 mA
`
`FIG. 14C
`
`
`
`15
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 11 0131
`
`US 8,005,535 B2
`
`VPP
`
`I
`2
`
`I
`4
`
`Stimulation Threshold
`to be Found
`
`IS
`
`F Stimulation mA
`
`FIG. 14A
`
`|
`
`|
`
`|
`|
`I
`I
`|
`I
`i 12
`8
`0.1 mAlncrementsi
`Result
`
`|
`
`|
`
`I >
`16
`
`FIG. 14D
`
`|
`2
`
`|
`4
`
`|
`|
`8
`
`i
`
`|
`|
`$12
`
`| >
`16
`
`EMG Response - No
`Lower Boundary
`
`
`
`i *
`
`;
`E
`
`EMG Response - Yes
`Upper Boundary
`
`Switching Between Response and no Response
`
`FIG. 14E
`
`
`
`16
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`Aug. 23, 2011
`
`Sheet 12 0131
`M
`
`US 8,005,535 B2
`m
`w0,
`
`<E5:21.53
`
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`17
`
`
`
`17
`
`
`
`

`

`US. Patent
`US. Patent
`
`Aug. 23, 2011
`Aug. 23, 2011
`
`Sheet 13 0f 31
`Sheet 13 0f 31
`
`US 8,005,535 B2
`US 8,005,535 B2
`
`FIG.16
`
`ww
`
`18
`
`
`
`18
`
`
`
`

`

`US. Patent
`US. Patent
`
`Aug. 23, 2011
`Aug. 23, 2011
`
`Sheet 14 0f 31
`Sheet 14 0f 31
`
`US 8,005,535 B2
`US 8,005,535 B2
`
`D. .QE
`
`FIG.17
`
`19
`
`
`
`19
`
`
`
`

`

`US. Patent
`US. Patent
`
`Aug. 23, 2011
`Aug. 23, 2011
`
`Sheet 15 0f 31
`Sheet 15 0f 31
`
`US 8,005,535 B2
`US 8,005,535 B2
`
`FIG.18
`
`2, .QE
`
`20
`
`
`
`20
`
`
`
`

`

`U.S. Patent
`
`Au .23 2011
`
`Sheet 16 0131
`
`
`
`
`
`21
`
`
`
`

`

`U.S. Patent
`
`Aug. 23, 2011
`
`Sheet 17 of 31
`
`US 8,005,535 132
`
`wiiiaiai
`2::that:2.5A
`
`3.53:.
`
`cm.0."—
`
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`.3235».
`
`
`
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`
`
`
`22
`
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 18 0f 31
`
`US 8,005,535 B2
`
`A
`
`L“
`:3
`
`z2t
`
`o U U
`
`)
`E‘Ihl
`
`THRESHOLD
`
`DETECTION
`
`g Q
`
`SciaticNerve L331$2 m
`
`
`
`BicepsFemoris
`
`8‘]
`
`23
`
`2 :
`
`2>3 f
`
`l
`
`
`
`23
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 19 0131
`
`US 8,005,535 B2
`
`
`
`{Electrode 1} (R,y1)
`
`d1
`
`{Electrode 4} (-x1,R) d4
`
`d2 {Electrode 2} (x1,R)
`
`d3 {Electrode 3} (R,-y1)
`
`
`
`FIG. 22
`
`24
`
`
`
`24
`
`
`
`

`

`U.S. Patent
`
`Aug. 23, 2011
`
`Sheet 20 of 31
`
`US 8,005,535 B2
`
`3—005
`
`mEoEm...
`
`MN.9."—
`
`25
`
`
`
`25
`
`
`
`

`

`U.S. Patent
`
`Aug. 23, 2011
`
`Sheet 21 0f 31
`
`US 8,005,535 B2
`
`magmas
`
`mtnmtmfi
`
`.VN.0.“—
`
`26
`
`
`
`26
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 22 0f 31
`
`US 8,005,535 B2
`
`u.
`
`(I
`
`ScrewTest
`
`200
`
`100@Stimulation
`
`
`
`ThresholdValues
`
`3 m W31.
`w-n‘llmmmld
`llull' JII‘ mum-I
`Tub-V um)
`
`23
`23
`>3
`:3
`Z'
`
`Relative
`
`Basenne
`
`FIG.25
`
`81
`
`27
`
`
`
`27
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 23 0f 31
`
`US 8,005,535 B2
`
`Relative
`
`ScrewTest
`
`200
`
`100@Stimulation
`
`‘
`
`
`
`ThresholdValues
`
`NUVASIVE
`
`Actual
`
`BaseHne
`
`28
`
`FIG.26
`
`
`
`BicepsFemoris
`
`
`
`28
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 24 0f 31
`
`US 8,005,535 B2
`
`Relative
`
`@Stimulation
`
`
`
`ThresholdValues
`
`ScrewTest
`
`NUVASIVE
`
`@
`
`Actual
`
`Basefine
`
`29
`
`FIG.27
`
`
`
`BicepsFemoris
`
`
`
`29
`
`
`
`

`

`US. Patent
`
`Aug. 23, 2011
`
`Sheet 25 0f 31
`
`US 8,005,535 B2
`
`EMG
`Vpp
`
`
`
`[- Saturation A
`
`
`
`
`/_”mun“...
`
`Saturation B
`
`,, ,. r“ <—(Threshold)
`
`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
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`30
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`

`

`U.S. Patent
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`Au .23 2011
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`Sheet 26 0f31
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`US 8,005,535 B2
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`31
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`US. Patent
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`Aug. 23, 2011
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`Sheet 27 0f 31
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`US 8,005,535 B2
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`FIG. 31
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`

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`US 8,005,535 132
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`U.S. Patent
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`Aug. 23, 2011
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`Sheet 29 of 31
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`US 8,005,535 B2
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`U.S. Patent
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`Aug. 23, 2011
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`Sheet 30 of 31
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`US. Patent
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`Aug. 23, 2011
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`Sheet 31 0f 31
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`US 8,005,535 B2
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`

`US 8,005,535 B2
`
`1
`SYSTEM AND METHODS FOR
`PERFORMING SURGICAL PROCEDURES
`AND ASSESSMENTS
`
`CROSS-REFERENCE TO RELATED
`
`APPLICATION(S)
`
`This application is a continuation of US. patent applica-
`tion Ser. No. 10/809,280 filed by Gharib et al. on Mar. 25,
`2004 (the contents being incorporated herein by reference),
`which is a continuation of PCT Patent Application Ser. No.
`PCT/USO2/30617 filed on Sep. 25, 2002 and published as
`WO 03/026482 (the contents being incorporated herein by
`reference), which claims priority to US. Patent Provisional
`Application Ser. No. 60/325,424 filed by Gharib et al. on Sep.
`25, 2001 (the contents being incorporated herein by refer-
`ence).
`
`BACKGROUND
`
`I. Field of the Invention
`
`The present invention relates to a system and methods
`generally aimed at surgery. More particularly, the present
`invention is directed at a system and related methods for
`performing surgical procedures and assessments involving
`the use of neurophysiology.
`II. Description of Related Art
`A variety of surgeries involve establishing a working chan-
`nel to gain access to a surgical target site. Ofte