(12) Ulllted States Patent
`Miles et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 8,016,767 B2
`*Sep. 13, 2011
`
`US008016767B2
`
`(54) SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`(56)
`
`(75) Inventors: Patrick Miles, San Diego, CA (US);
`Scot Martinelli, Mountain Top, PA
`(Us); Eric Finley, Lancaster, CA(US)
`
`(73) Assignee: NuVasive, Inc., San Diego, CA (US)
`
`~
`
`~
`
`~
`
`'
`
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`_
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`
`Primary Examiner * Mark W Bockelman
`(74) Attorney, Agent, or Firm * Fish & Richardson PC.
`
`(57)
`
`ABSTRACT
`
`A surgical access system including a tissue distraction assem
`bly and a tissue retraction assembly, both of Which may be
`equipped With one Or more electrodes for use in detecting the
`existence of (and optionally the distance and/ or direction to)
`neural Structures before, (Wing, and after the establishment
`ofan operative corridor to a surgical target site.
`
`20 Claims, 22 Drawing Sheets
`
`39
`
` 1
`
`NUVASIVE 1063
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

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`Medtronic Sofamor Danek USA, 2000, 21 pgs.
`Medtronic Sofamor Danek “METRx System Surgical Technique,”
`2004, 22 pages.
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`Surgical Technique” Medtronic Sofamor Danek, 2000, 24 pages.
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`Lateral Impacted Fusion Devices: Clear choice of stabilization”
`Medtronic Sofamor Danek, 2000, 4 pages.
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`NuVasive TriadTM Tri-Columnar Spinal EndoArthrodesisTM via
`Minimally Invasive Guidance, 1 page (prior to Sep. 25, 2003).
`NuVasive TriadTM Cortical Bone Allograft, 1 page (prior to Sep. 25,
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`Arthrodesis,” Spineline, 2000, p. 39.
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`NuVasive letter re 510k Guided Arthroscopy System, dated Oct. 5,
`1999, 6 pages.
`NuVasive letter re 510k INS-1 Intraoperative Nerve Surveillance
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`NuVasive letter re: 510(k) for Neurovision JJB System (Summary),
`Sep. 25, 2001, 28 pages.
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`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.
`
` 4
`
`
`
`

`
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`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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`NuVasive letter re 510(k) Premarket Noti?cation INS-1 Intraopera
`tive Nerve Surveillance System, Aug. 24, 2000, 81 pages.
`Isley et al., “Recent Advances in Intraoperative Neuromonitoring of
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`Sofamor Danek, 2001, 20 pages.
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`Infringement Contentions Regarding USP 7207949; 7470236 and
`7582058, Aug. 31, 2009, 21 pages.
`The 9th IMAST: “Initial Clinical Results of Direct Lateral, Mini
`mally Invasive Access to the Lumbar Spine for Disc Nucleus
`Replacement Using a Novel Neurophysiologic Monitoring System”
`May 2002, 1 page.
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`“The Lateral Endoscopic Trasnpsoas Retroperitoneal Approach
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`“NuVasive’s spine surgery system cleared in the US,” Pharm &
`Medical Industry Week, Dec. 10, 2001, 1 page.
`
` 5
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`

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`US. Patent
`U.S. Patent
`
`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 1 0122
`Sheet 1 of 22
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`US 8,016,767 B2
`US 8,016,767 B2
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`FIG. 1
`FIG. 1
`
` 6
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`
`US. Patent
`
`Sep. 13, 2011
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`Sheet 2 0122
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`US 8,016,767 B2
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`FIG. 2
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` 7
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`

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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 3 0122
`Sheet 3 of 22
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`US 8,016,767 B2
`US 8,016,767 B2
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`37
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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Se .13 2011
`
`Sheet 4 0122
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`US 8,016,767 B2
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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Sep. 13, 2011
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`Sheet 5 0122
`Sheet 5 of 22
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`US 8,016,767 B2
`US 8,016,767 B2
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`US. Patent
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`Sep. 13, 2011
`
`Sheet 6 6f 22
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`US 8,016,767 B2
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`US. Patent
`U.S. Patent
`
`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 8 0122
`Sheet 8 of 22
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`US 8,016,767 B2
`US 8,016,767 B2
`
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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 9 0122
`Sheet 9 of 22
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`US 8,016,767 B2
`US 8,016,767 B2
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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 10 0122
`Sheet 10 of 22
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`US 8,016,767 B2
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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 11 0122
`Sheet 11 of 22
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`US 8,016,767 B2
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`US. Patent
`U.S. Patent
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`Sep. 13, 2011
`Sep. 13, 2011
`
`Sheet 12 0122
`Sheet 12 of 22
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`US 8,016,767 B2
`US 8,016,767 B2
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`US. Patent
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`Sep. 13, 2011
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`Sep. 13, 2011
`Sep. 13, 2011
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`US 8,016,767 B2
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`Sep. 13, 2011
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`US 8,016,767 B2
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`Sep. 13, 2011
`
`Sheet 22 of 22
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`US 8,016,767 B2
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`DETECTIONDIRECTION
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`US 8,016,767 B2
`
`1
`SURGICAL ACCESS SYSTEM AND RELATED
`METHODS
`
`CROSS-REFERENCES TO RELATED
`APPLICATIONS
`
`The present application is a continuation of commonly
`owned U.S. patent application Ser. No. 11/137,169, filed on
`May 25, 2005 (now U.S. Pat. No. 7,207,949), which is a
`continuation of PCT application Ser. No. PCT/US04/31768,
`filed Sep. 27, 2004, which claims the benefit of priority from
`commonly owned U.S. Provisional Patent Application Ser.
`No. 60/506,136, filed Sep. 25, 2003, the entire contents of
`which are hereby expressly incorporated by reference into
`this disclosure as if set forth fully herein. The present appli-
`cation also incorporates by reference the following co-pend-
`ing and co-assigned patent applications in their entireties:
`PCT App. Ser. No. PCT/US02/22247, entitled “System and
`Methods for Determining Nerve Proximity, Direction, and
`Pathology During Surgery,” filed on Jul. 11, 2002; PCT App.
`Ser. No. PCT/US02/30617, entitled “System and Methods for
`Performing Surgical Procedures and Assessments,” filed on
`Sep. 25, 2002; PCT App. Ser. No. PCT/US02/35047, entitled
`“System and Methods for Performing Percutaneous Pedicle
`Integrity Assessments,” filed on Oct. 30, 2002; and PCT App.
`Ser. No. PCT/US03/02056, entitled “System and Methods for
`Determining Nerve Direction to a Surgical Instrument,” filed
`Jan. 15, 2003 (collectively “NeuroVision PCT Applica-
`tions”).
`
`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
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`
`operative corridor, such as (by way of example only) the
`sequential dilation system ofU.S. Pat. No. 5,792,044 to Foley
`et al., these attempts are nonetheless limited in their applica-
`bility based on the relatively narrow operative corridor. More
`specifically, based on the generally cylindrical nature of the
`so-called “working carmula,” 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 U.S. 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 m