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`PAUL D. TRIPODI II
`State Bar No. 162380
`ptripodi@wsgr.com
`Wilson Sonsini Goodrich & Rosati P.C.
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`Telephone: 323-210-2900
`Fax: 866-974-7329
`
`NATALIE J. MORGAN
`State Bar No. 211143
`nmorgan@wsgr.com
`Wilson Sonsini Goodrich & Rosati P.C.
`12235 El Camino Real
`San Diego, CA 92130
`Telephone: 858-350-2300
`Fax: 858-350-2399
`
`WENDY L. DEVINE
`State Bar No. 246337
`wdevine@wsgr.com
`Wilson Sonsini Goodrich & Rosati P.C.
`One Market Plaza
`Spear Tower, Suite 3300
`San Francisco, California 94105-1126
`Telephone: 415-947-2000
`Fax: 415-947-2099
`
`Attorneys for Plaintiff NuVasive, Inc.
`
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`SAN DIEGO DIVISION
`
`
`NUVASIVE, INC., a Delaware
`corporation,
`
` Plaintiff,
`
`v.
`
`ALPHATEC HOLDINGS, INC., a
`Delaware corporation, and ALPHATEC
`SPINE, INC., a California corporation,
`
` Defendants.
`
`
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`
`
`CASE NO. 3:18-cv-0347-CAB-
`MDD
`DECLARATION OF JIM A.
`YOUSSEF, M.D. IN SUPPORT
`OF NUVASIVE’S MOTION
`FOR PRELIMINARY
`INJUNCTION
`
`Judge: Hon. Cathy Ann
`Bencivengo
`Courtroom: 4C
`Hearing Date: May 10, 2018
`
`JURY TRIAL DEMANDED
`
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`3:18-cv-00347-CAB-MDD
`
`NUVASIVE - EXHIBIT 2013
`Alphatec Holdings Inc. et al. v. NuVasive, Inc. - IPR2019-00362
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2845 Page 2 of 116
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`TABLE OF CONTENTS
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`Page
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`
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`B.
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`BACKGROUND ......................................................................................... 1
`I.
`EXPERT QUALIFICATIONS .................................................................... 1
`II.
`III. LEGAL STANDARDS PROVIDED BY COUNSEL .................................. 3
`IV. SUMMARY OF OPINIONS ....................................................................... 4
`V.
`BACKGROUND ......................................................................................... 5
` History of Spinal Fusion Procedures Prior to XLIF ............................ 5
`A.
`XLIF Solves the Problems Associated With Other Procedures ........ 14
`i.
`Access Tools .......................................................................... 16
`ii.
`Implant .................................................................................. 19
`iii. Neuromonitoring.................................................................... 20
`iv. NuVasive’s Patents ................................................................ 21
`VI. ALPHATEC’S PRODUCTS ..................................................................... 22
`VII. PERSON OF ORDINARY SKILL IN THE ART ...................................... 23
`VIII. CLAIM CONSTRUCTION ....................................................................... 24
`
`Lateral, Trans-Psoas Path ................................................................. 25
`A.
`One Another .................................................................................... 25
`
`Rigidly Coupled ............................................................................... 26
`C.
`Closed Position ................................................................................ 26
`D.
`Opened ............................................................................................ 27
`E.
`Groove ............................................................................................. 27
`IX. U.S. PATENT NO. 7,819,801 .................................................................... 28
`
`Claim 1 ............................................................................................ 29
`
`B.
`
`Pivoting First And Second Pivotable Arm Members Relative To
`
`F.
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`A.
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-i-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2846 Page 3 of 116
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`A system for accessing a surgical target site, comprising ....... 29
`targeted spinal site to create a distraction corridor; ................ 30
`first and second arm members; ............................................... 31
`
`a dilator system comprising a plurality of sequential
`dilators deliverable along a lateral, trans-psoas path to a
`
`a handle assembly including a first pivotable arm member,
`a second pivotable arm member that pivots relative to said
`first arm member in response to manual adjustment of a
`component of the handle assembly, and a translating
`member adapted to move longitudinally relative to said
`
`i.
`ii.
`iii.
`iv.
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`v.
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`vi.
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`a first retractor blade having a generally concave inner
`facing surface and being rigidly coupled to said first
`pivotable arm member prior to introduction toward the
`targeted spinal site, a second retractor blade having a
`generally concave inner-facing surface and being rigidly
`coupled to said second pivotable arm member prior to
`introduction toward the targeted spinal site, and a third
`retractor blade rigidly coupled to said translating member
`
`prior to introduction toward the targeted spinal site; .............. 33
`
`an intradiscal shim element that releasably mounts to the
`third retractor blade such that a maximum length of the
`intradiscal shim element extends generally parallel to a
`maximum length of the third retractor blade and a distal
`tip portion of the intradiscal shim element extends distally
`of the distal end of the third retractor blade, wherein the
`intradiscal shim element engages with a groove defined by
`the third retractor blade to penetrate into a spinal disc at
`the targeted spinal site when the intradiscal shim element
`
`is releasably mounted to the third retractor blade; and ........... 35
`
`said handle assembly being configured to simultaneously
`introduce said first, second and third retractor blades along
`the lateral, trans-psoas path toward the targeted spinal site
`in a closed position while the generally concave inner-
`facing surfaces of said first and second retractor blades
`engage with an outermost dilator of the dilator system and
`thereafter opened by pivoting said first and second
`pivotable arm members relative to one another to create an
`
`operative corridor to said surgical target site. ......................... 36
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-ii-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2847 Page 4 of 116
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`Claim 2: The system of claim 1, further comprising a K-wire
`configured to be advance along the lateral, trans-psoas path to
`the targeted spinal site and engage an annulus of said spinal disc,
`the K-wire further configured to extend entirely through a dilator
`of said dilator system from the annulus of the spinal disc to a
`
`Claim 6: The system of claim 1, wherein at least one of said
`plurality of sequential dilators is equipped with at least one
`
`Claim 15: The system of claim 1, wherein each of the plurality of
`sequential dilators includes a stimulation electrode at a distal
`
`position beyond a proximal most end of the dilator system. ............. 38
`stimulation electrode. ....................................................................... 38
`region. .............................................................................................. 39
`deliverable over the K-wire. ............................................................. 39
`concave inner-facing surface. ........................................................... 40
`groove of the third retractor blade. ................................................... 40
`said second arm member. ................................................................. 40
`toward the targeted spinal site. ......................................................... 41
`retractor blade is spaced apart from the second retractor blade. ........ 41
`
`Claim 16: The system of claim 15, further comprising a K-wire
`configured to be advanced to the targeted spinal site and to
`engage an annulus of said spinal disc at the targeted spinal site,
`wherein at least one of the plurality of sequential dilators are
`
`Claim 19: The system of claim 1, wherein the third retractor
`blade includes a generally concave inner-facing surface and the
`groove of the third retractor blade is formed along the generally
`
`Claim 20: The system of claim 19, wherein the intradiscal shim
`element includes at least one dovetail element to mate with the
`
`Claim 23: The system of claim 1, wherein said handle is
`configured to simultaneously move said first arm member and
`
`Claim 26: The system of claim 1, further comprising a shim
`insertion tool that releasably attaches to the intradiscal shim
`element during introduction of the intradiscal shim element
`
`Claim 28: The system of claim 1, wherein the handle assembly
`further includes a locking mechanism to selectively lock at least
`the first arm member in a retracted position such that the first
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-iii-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2848 Page 5 of 116
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`
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`K.
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`A.
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`Claim 29: The system of claim 1, wherein the first, second, and
`third retractor blades define an operative corridor to the targeted
`spinal site when moved to the opened position such that an
`implant is deliverable through the operative corridor to the
`
`A system for forming an operating corridor to a lumbar
`
`
`targeted spinal site. .......................................................................... 41
`X. U.S. PATENT NO. 8,355,780 .................................................................... 42
`Claim 21 .......................................................................................... 43
`
`i.
`spine, comprising: .................................................................. 43
`ii.
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`a dilator system to create a distraction corridor along a
`lateral, trans-psoas path to the lumbar spine, wherein said
`dilator system comprises at least two dilators of
`sequentially larger widths deliverable to a spinal disc
`along the lateral, trans-psoas path to the lumbar spine, a
`second dilator of said at least two dilators being slidably
`engageable with an exterior of a first of said at least two
`dilators, at least one of the first and second dilators
`including a stimulation electrode to deliver electrical
`stimulation for nerve monitoring when the stimulation
`electrode is positioned along the lateral, trans-psoas path
`
`to the lumbar spine;................................................................ 44
`path, the three-bladed retractor assembly including: .............. 45
`relative to arm members of the blade holder assembly, .......... 45
`
`a three-bladed retractor assembly slidable over the dilator
`system toward the spinal disc along the lateral, trans-psoas
`
`a blade holder assembly and first, second, and third
`retractor blades that extend generally perpendicularly
`
`iii.
`iv.
`v.
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`wherein the three-bladed retractor assembly is adjustable
`from a first position in which the first, second, and third
`retractor blades are adjacent to one another and slidable
`over the dilator system to a second position in which the
`second and third retractor blades are moved away from the
`first retractor blade to enlarge the distraction corridor and
`thereby form an operative corridor along the lateral, trans-
`
`psoas path to the lumbar spine, .............................................. 46
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-iv-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2849 Page 6 of 116
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`vi. wherein the first retractor blade is linearly movable
`assembly, ............................................................................... 47
`vii. wherein the second refractor blade is movable relative to
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`relative to the second and third retractor blades in response
`to rotation of a knob element on the blade holder
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`the first blade in response to pivoting movement of a first
`pivotable arm member of said arm members which is
`coupled to the second retractor blade, and wherein the
`third retractor blade is movable relative to the first blade in
`response to pivoting movement of a second pivotable arm
`member of said arm members which is coupled to the third
`
`adjusted to the second position to form the operative
`corridor along the lateral, trans-psoas path to the lumbar
`spine, the first retractor blade is a posterior-most retractor
`blade of the first, second, and third retractor blades and the
`operative corridor is dimensioned so as to pass an implant
`
`refractor blade; and ................................................................ 48
`viii. wherein when the three-bladed retractor assembly is
`through the operative corridor and into the lumbar spine. ...... 49
`refractor blade. ................................................................................. 50
`retractor blade relative to the second and third retractor blades. ....... 50
`
`Claim 22: The system of claim 21, wherein when the three-
`bladed retractor assembly is adjusted to the second position to
`form the operative corridor, the first retractor blade is the
`posterior-most retractor blade, the second blade is a cephalad-
`most retractor blade, and the third blade is a caudal-most
`
`Claim 24: The system of claim 21, wherein said arm members of
`the blade holder assembly further comprise a translating arm
`member coupled to the first retractor blade, wherein the rotation
`of the knob element of the blade holder assembly causes the
`translating arm member to linearly adjust a position of the first
`
`Claim 25: The system of clam 21, wherein the three-bladed
`retractor assembly includes an intradiscal shim element having a
`proximal portion removably engageable with the first retractor
`blade so that a distal portion of the shim element extends from a
`distal end of the first retractor blade and is configured to
`penetrate into the spinal disc, wherein the proximal portion of the
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-v-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2850 Page 7 of 116
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`shim element is slidably engageable with grooves defined along
`
`Claim 26: The system of claim 21, wherein the second and third
`retractor blades are configured to simultaneously move in
`response to movement of the first and second pivotable arm
`
`Claim 28: The system of claim 21, wherein when the three-
`bladed retractor assembly is in the first position, the first, second,
`and third retractor blades are in generally abutting relation with
`
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`E.
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`F.
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`A.
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`the first retractor blade. .................................................................... 51
`
`members. ......................................................................................... 51
`
`one another. ..................................................................................... 52
`XI. U.S. PATENT NO. 8,439,832 .................................................................... 52
`
`Claim 1 ............................................................................................ 53
`i.
`spine, comprising: .................................................................. 53
`ii.
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`A system for forming an operating corridor to a lumbar
`
`a distraction assembly to create a tissue distraction
`corridor in a lateral, trans-psoas path to a lumbar spine,
`wherein said distraction assembly includes an elongate
`inner element and a plurality of dilators, the plurality of
`dilators being configured to sequentially advance along the
`lateral, trans-psoas path to the lumbar spine, the elongate
`inner element being positionable in a lumen of an initial
`dilator of the plurality of dilators, wherein at least one
`instrument from the group consisting of said elongate
`inner element and said dilators includes a stimulation
`electrode that outputs electrical stimulation for nerve
`monitoring when the at least one instrument is positioned
`
`in the psoas muscle; ............................................................... 54
`the three-bladed retractor assembly including: ....................... 55
`a blade-holder assembly, and ................................................. 55
`
`a three-bladed retractor tool slidable over an exterior of an
`outermost sequential dilator of the dilator system toward
`the targeted spinal disc along the lateral, trans-psoas path,
`
`a posterior-most retractor blade, a cephalad-most retractor
`blade, and a caudal-most retractor blade that extend from
`the blade-holder assembly, wherein the posterior-most,
`
`iii.
`iv.
`v.
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-vi-
`
`3:18-cv-00347-CAB-MDD
`
`

`

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`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-vii-
`
`3:18-cv-00347-CAB-MDD
`
`cephalad-most, and caudal-most retractor blades are
`slidably advanced over the exterior of the outermost
`sequential dilator while in a first position, wherein the
`blade-holder assembly is adjust able to move the posterior-
`most, cephalad-most, and caudal-most retractor blades to a
`second position in which the cephalad-most and caudal-
`most retractor blades are spaced apart from the posterior-
`
`the operative corridor along the lateral, trans-psoas path to
`the lumbar spine in which a space extending to the
`targeted spinal disc between the posterior-most, cephalad-
`most, and caudal-most refractor blades is dimensioned so
`as to pass an implant through the operative corridor along
`
`most retractor blade to define an operative corridor, .............. 56
`vi. wherein three-bladed retractor tool is configured to define
`the lateral, trans-psoas path to the lumbar spine. .................... 57
`generally stationary position relative to the targeted spinal disc. ...... 58
`member comprises a K-wire. ........................................................... 58
`and maintained generally parallel to one another. ............................ 58
`cephalad-most, and caudal-most refractor blades. ............................ 59
`toward the targeted spinal disc. ........................................................ 59
`
`Claim 2: The system of claim 1, wherein the blade-holder
`assembly is adjustable to move the cephalad-most and caudal-
`most retractor blades away from the posterior-most retractor
`blade while the posterior-most retractor blade remains in a
`
`Claim 4: The system of claim 1, wherein the elongate inner
`
`Claim 6: The system of claim 1, wherein when the three-bladed
`retractor tool defines the operative corridor, the posterior most,
`cephalad-most, and caudal-most retractor blades are spaced apart
`
`Claim 7: The system of claim 1, wherein when the three-bladed
`retractor tool is in the first position, each of the posterior most,
`cephalad-most, and caudal-most retractor blades at least partially
`abuts with edges of the other two of the posterior-most,
`
`Claim 8: The system of claim 1, wherein further comprising a
`light emitting device to direct light through the operative corridor
`
`Claim 9: The system of claim 1, further comprising a fourth
`retractor blade that couples with the blade-holder assembly only
`
`

`

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`after the blade-holder assembly moves the posterior most,
`cephalad-most, and caudal-most retractor blades to the second
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`A method for accessing a spinal disc of a lumbar spine of
`
`position. ........................................................................................... 60
`Claim 12 .......................................................................................... 61
`i.
`a patient, comprising: ............................................................. 61
`ii.
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`iii.
`iv.
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`v.
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`sequentially inserting a plurality of sequentially larger
`diameter dilators into said patient along a lateral, trans
`psoas path to create a distraction corridor along said
`lateral, trans-psoas path toward a targeted spinal disc,
`wherein an initial dilator of said plurality of sequentially
`larger diameter dilators is configured to receive an
`elongate inner element, wherein at least one of said
`elongate inner element and said sequential dilators
`
`comprises a stimulation electrode; ......................................... 61
`trans-psoas path; .................................................................... 62
`
`outputting electrical stimulation from said stimulation
`electrode of said at least one of said elongate inner element
`and said sequential dilators for nerve monitoring when
`said stimulation electrode is positioned in said lateral,
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`simultaneously advancing a posterior-most retractor blade,
`a cephalad-most retractor blade, and a caudal-most
`retractor blade of a three-bladed retractor tool along said
`lateral, trans-psoas path and over an exterior of an
`outermost dilator of said plurality of sequentially larger
`diameter dilators, said three-bladed refractor tool
`comprising a blade holder assembly and said posterior-
`most, cephalad-most, and caudal-most refractor blades
`
`attached to said blade holder assembly:.................................. 63
`
`removing said plurality of sequentially larger diameter
`dilators from said patient after said posterior-most,
`cephalad-most, and caudal-most retractor blades are
`advanced through the psoas muscle, wherein an operative
`corridor along the lateral, trans-psoas path to the targeted
`spinal disc is at least partially defined by said posterior-
`most, cephalad-most, and caudal-most retractor blades;
`
`and ......................................................................................... 63
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-viii-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2853 Page 10 of
` 116
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`vi. maintaining said operative corridor along said lateral,
`targeted spinal disc................................................................. 64
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`trans-psoas path using said three-bladed retractor tool
`while delivering a spinal implant to a disc space of the
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`I.
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`J.
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`Claim 13: The method of claim 12, further comprising adjusting
`said blade holder assembly so as to move said cephalad-most and
`caudal-most retractor blades away from said posterior most
`retractor blade to create said operative corridor along said lateral,
`trans-psoas path to said targeted spinal disc, wherein said
`operative corridor is dimensioned so as to pass a spinal implant
`through said operative corridor along said lateral, trans-psoas
`
`Claim 14: The method of claim 13, wherein said blade holder
`assembly is adjustable to move each of the cephalad-most and
`caudal-most retractor blades away from the posterior-most
`retractor blade while the posterior-most refractor blade remains
`in a generally stationary position relative to the targeted spinal
`
`Claim 16: The method of claim 12, further comprising activating
`a light emitting device to direct light through said operative
`corridor toward the targeted spinal disc, the light emitting device
`being coupled to one of the posterior-most, cephalad-most, and
`
`Claim 17: The method of claim 12, further comprising advancing
`said elongate inner member along said lateral, trans-psoas path
`
`of sequentially larger diameter dilators comprises a distal end on
`which a respective stimulation electrode is situated, said distal
`end being angled relative to a longitudinal axis of said dilator
`such that said stimulation electrode is angled relative to said
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`path to said targeted spinal disc. ....................................................... 64
`disc. ................................................................................................. 65
`caudal-most blades. .......................................................................... 65
`and into the disc space. .................................................................... 66
` Claim 19: The method of claim 12, wherein each of said plurality
`longitudinal axis............................................................................... 66
` Alphatec’s devices are designed to perform the claimed method ..... 67
`XII. U.S. PATENT NO. 9,833,227 .................................................................... 67
`Claim 1 ............................................................................................ 68
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`K.
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`L.
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`M.
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`N.
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`A.
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`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-ix-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2854 Page 11 of
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`i.
`ii.
`iii.
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`iv.
`v.
`vi.
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`A method for forming an operating corridor to a lumbar
`spine of a patient, the patient having an anterior aspect, a
`posterior aspect and two lateral aspects, the method
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`comprising ............................................................................. 68
`second diameter; .................................................................... 69
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`inserting a plurality of dilators into the patient at an
`insertion position on one of the two lateral aspects of the
`patient, the plurality of dilators comprising a first dilator
`having a first diameter and a second dilator having a
`second diameter, the first diameter being smaller than the
`
`advancing the plurality of dilators along a lateral, trans-
`psoas path to a lateral aspect of a target intervertebral disc
`of the lumbar spine, the lateral, trans-psoas path having a
`path axis that extends from the insertion position on the
`one of the two lateral aspects to the other of the two lateral
`aspects of the patient, to create a tissue distraction corridor
`along the lateral, trans-psoas path through a region of a
`psoas muscle containing nerves to the target intervertebral
`disc, the tissue distraction corridor negotiating past the
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`electrically stimulating, using a stimulation electrode
`along a distal region of a dilator of the plurality of dilators,
`the nerves of the psoas muscle for monitoring a nerve
`response, and advancing the dilator along the lateral, trans-
`psoas path, based on the monitoring, to avoid directly
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`nerves of the psoas muscle; .................................................... 70
`contacting the nerves of the psoas muscle; ............................. 71
`lateral, trans-psoas path; and .................................................. 71
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`moving a plurality of retractor blades along the lateral,
`trans-psoas path to form an operative corridor along the
`
`adjusting the plurality of retractor blades from a first
`configuration comprising the plurality of retractor blades
`in a first position to a second configuration comprising the
`plurality of retractor blades in a second position in which
`the plurality of retractor blades are spaced further apart
`from one another to form the operative corridor along the
`lateral, trans-psoas path, the operative corridor negotiating
`past the nerves of the psoas muscle without damaging the
`nerves and being dimensioned to pass an implant there
`
`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-x-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`target intervertebral disc of the lumbar spine. ........................ 72
`retractor blades comprises moving a posterior retractor blade. ......... 73
`retractor blades comprises moving an anterior retractor blade. ......... 74
`blade and a cephalad retractor blade................................................. 74
`region of each of the first dilator and the second dilator. .................. 75
`blades over at least one of the plurality of dilators. .......................... 75
`lumbar spine of a patient, the method comprising: ........................... 75
`i.
`than the second diameter; ....................................................... 76
`ii.
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`through along the lateral, trans-psoas path toward the
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`Claim 2: The method of claim 1, wherein moving the plurality of
`
`Claim 4: The method of claim 2, wherein moving the plurality of
`
`Claim 6: The method of claim 2, wherein moving the plurality of
`retractor blades further comprises moving a caudal retractor
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`Claim 13: The method of claim 1, wherein electrically
`stimulating the nerves comprises electrically stimulating the
`nerves using a respective stimulation electrode along a distal
`
`Claim 15: The method of claim 1, wherein moving the plurality
`of retractor blades comprises moving the plurality of retractor
`
`Claim 16: A method for forming an operating corridor to a
`
`inserting a plurality of dilators into the patient at an
`insertion position on one of two anatomically lateral
`aspects of the patient, the plurality of dilators comprising a
`first dilator having a first diameter and a second dilator
`having a second diameter, the first diameter being smaller
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`advancing the plurality of dilators along a lateral, trans-
`psoas path from the insertion position on the one of two
`anatomically lateral aspects of the patient to a lateral
`aspect of a target intervertebral disc of the lumbar spine,
`the trajectory of the lateral, trans-psoas path exiting the
`patient at the other of the two anatomically lateral aspects
`of the patient, to create a tissue distraction corridor to the
`target intervertebral disc along the lateral, trans-psoas
`path, the lateral, trans-psoas path extending through a
`region of a psoas muscle containing nerves and
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`negotiating past the nerves; .................................................... 76
`
`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2855 Page 12 of
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`DECLARATION OF JIM A. YOUSSEF,
`M.D.
`
`
`-xi-
`
`3:18-cv-00347-CAB-MDD
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 37-45 Filed 04/05/18 PageID.2856 Page 13 of
` 116
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`iii.
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`electrically stimulating, using a stimulation electrode
`along a distal region of the first dilator or the second
`dilator, the nerves of the psoas muscle for monitoring a
`nerve response and advancing the first dilator or the
`second dilator, based on the mnitoring, along the lateral,
`trans-psoas path to avoid impairment of the nerves of the
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`the plurality of dilators along the lateral, trans-psoas path
`to form an operative corridor along the lateral, trans-psoas
`path, the operative corridor being dimensioned to pass an
`implant therethrough along the lateral, trans-psoas path
`
`Claim 17: The method of claim 16, wherein moving the plurality
`
`Claim 19: The method of claim 17, wherein moving the plurality
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`Claim 22: The method of claim 17, wherein moving the plurality
`of retractor blades further comprises moving a caudal retractor
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