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`EXHIBIT 16
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`
`TO THE DECLARATION OF BRIAN J. NISBET
`IN SUPPORT OF DEFENDANTS’ MOTION
`FOR SUMMARY JUDGMENT OR, IN THE
`ALTERNATIVE, SUMMARY ADJUDICATION
`
`
`
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`

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`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Pub1ication Date
`20 April 2006 (20.04.2006)
`
`(51) International Patent Classification:
`A61M 5131 (2006.01)
`
`PCT
`
`(21) International Application Number:
`PCT/US2005/036454
`
`(22) International Filing Date: 11 October 2005 (11.10.2005)
`
`(25) l<'iling Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/617,498
`60/720,710
`
`8 October 2004 (08.10.2004)
`26 September 2005 (26.09.2005)
`
`us
`us
`
`(71) Applicant (for all designated States except US): NUVA(cid:173)
`SIVE, INC. [US/US]; 4545 Towne Centre Court, San
`Diego, CA 92121 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): JvL\RTINELLI,
`Scot [lJS/lJS]; 15973 Crown Valley Rd, San Diego,
`CA 92064 (US). ARAMBULA, Jared [US/US]; 1803
`Burton Street, San Diego, CA 92111 (US). FINLEY, Eric
`[US/US]; 5663 West L-6 Ave, Lancaster, CA 93536 (US).
`MILES, Patrick fUS/USl; 5227 Greenwillow Lane, San
`Diego, CA 92130 (US).
`
`(74) Agent: SPANGLER, .Jonathan, D.; 4545 Towne Centre
`Court, San Diego, CA 92121 (US) .
`
`!!!!!!!!!!! -
`
`!!!!!!!!!!! -
`
`1111111111111111 IIIIII IIIII 11111111111111111111111111111111111 IIIII IIIII IIII IIIIIII IIII IIII IIII
`
`(10) International Publication Number
`WO 2006/042241 A2
`(81) Designated States (unless otherwise indicaled, for every
`kind of national proteclion available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, Fl,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KM, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, LY,
`MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, Nl, NO,
`NZ, OM, PG, PH, PL, PT, RO, Rll, SC, SD, SE, SG, SK,
`SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ,
`VC, VN, YU, ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicaled, for every
`kind of regional protection available): ARlPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG. ZM,
`ZW), JJurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, Fl,
`FR, GB, GR, HU, TE, IS, IT, LT, LU, LV, MC, NL, PL, PT,
`RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA,
`GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Declaration under Rule 4.17:
`of inventorship (Rule 4.17(ivj)
`
`Published:
`wilhout international search report and to be republished
`upon receipt of that report
`
`For two-letter codes and other abbreviations, refer to the "Guid(cid:173)
`ance Notes on Codes and Abbreviations" appearing at the begin(cid:173)
`ning of each regular iss11P of the PCT Gazette.
`
`........
`~
`M
`M - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
`~ (54) Title: SURGICAL ACCESS SYSTEM AND RELATED 1-IBTHODS
`.........
`\0
`Q
`(57) Abstract: A surgical access system including a tissue distraction assembly 40 and a tissue retraction assembly 10, both of
`0 which may be equipped with one or more electrodes 23 for use in detecting the existence of (and optionally the distance and/or
`M direction to) neural strnctures before, during, and after the establishment of an operative corridor 15 to a surgical target site. The
`O tissue retraction assembly 10 has a plurality of blades 12, 16, 18 which may be introduced while in a closed configuration, after
`> which point they may be opened to create an operation corridor 15 to the surgical target site, including pivoting at least one blade
`
`~ 12, 16, 18 to expand the operative corridor 15 adjacent to the operative site.
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`A TEC _LLI F000849968
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`SURGICAL ACCESS SYSTEM AND RELATED lVIETHODS
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`CROSS-REFERENCES TO RELATED APPLICATIONS
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`The present international patent application claims the benefit of priority from commonly
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`5
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`owned and co-pending U.S. Provisional Patent Application Serial No. 60/617,498, entitled
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`"Surgical Access System and Related Methods," filed on October 8, 2004 and U.S. Provisional
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`Patent Application Serial No. 60/720,710, entitled "Surgical Access System and Related
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`Methods," filed on September 26, 2005, the entire contents of which are hereby expressly
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`incorporated by reference into this disclosure as if set forth fully herein. The present application
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`10
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`also incorporates by reference the following co-pending and co-assigned patent applications in
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`their entireties: PCT App. Ser. No. PCT/US02/22247, entitled "System and Methods for
`
`Determining Nerve Proximity, Direction, and Pathology During Surgery," filed on July 11, 2002;
`
`PCT App. Ser. No. PCT/US02/30617, entitled "System and Methods for Performing Surgical
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`Procedures and Assessments," filed on Sept. 25, 2002; PCT App. Ser. No. PCT/US02/35047,
`
`15
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`entitled "System and Methods for Performing Percutaneous Pedide Integrity Assessments," filed
`on October 30, 2002; and PCT App. Ser. Nb. PCT/US03/02056, entitled "System and Methods
`
`for Determining Nerve Direction to a Surgical Instrument," filed January 15, 2003 (collectively
`
`"Neuro Vision PCT Applications").
`
`20
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`BACKGROUND OF THE INVENTION
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`I. Field of the Invention
`
`The present invention relates generally to systems and methods for performing surgical
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`procedures and, more particularly, for accessing a surgical target site in order to perform surgical
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`25
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`procedures.
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`II. Discussion of the Prior Art
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`A noteworthy trend in the medical community is the move away from performing surgery
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`via traditional "open" techniques in favor of minimally invasive or minimal access techniques.
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`30 Open surgical techniques are generally undesirable in that they typically require large incisions
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`1
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`and high amounts of tissue displacement to gain access to the surgical target site, which produces
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`concomitantly high amounts of pain, lengthened hospitalization (increasing health care costs),
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`and high morbidity in the patient population. Less-invasive surgical techniques (including so(cid:173)
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`called "minimal access" and "minimally invasive" techniques) are gaining favor due to the fact
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`5
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`that they involve accessing the surgical target site via incisions of substantially smaller size with
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`greatly reduced tissue displacement requirements. This, in tum, reduces the pain, morbidity and
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`cost associated with such procedures. The access systems developed to date, however, fail in
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`various respects to meet all the needs of the surgeon population.
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`10
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`One drawback associated with prior art surgical access systems relates to the ease with
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`which the operative corridor can be created, as well as maintained over time, depending upon the
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`particular surgical target site. For example, when accessing surgical target sites located beneath
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`or behind musculature or other relatively strong tissue (such as, by way of example only, the
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`psoas muscle adjacent to the spine), it has been found that advancing an operative corridor-
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`15
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`establishing instrnment directly through such tissues can be challenging and/or lead to unwanted
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`or undesirable effects (such as stressing or tearing the tissues). While certain efforts have been
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`undertaken to reduce the trauma to tissue while creating an operative corridor, such as (by way of
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`example only) the sequential dilation system of US Pat No. 5,792,044 to Foley et al., these
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`attempts are nonetheless limited in their applicability based on the relatively narrow operative
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`20
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`corridor. More specifically, based on the generally cylindrical nature of the so-called "working
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`cannula," the degree to which instrnments can be manipulated and/or angled within the cannula
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`can be generally limited or restrictive, particularly if the surgical target site is a relatively deep
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`within the patient.
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`25
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`This highlights yet another drawback with the prior art surgical access systems, namely,
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`the challenges in establishing an operative corridor through or near tissue having major neural
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`strnctures which, if contacted or impinged, may result in neural impairment for the patient. Due
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`to the threat of contacting such neural structures, efforts thus far have largely restricted to
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`establishing operative corridors through tissue having little or substantially reduced neural
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`30
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`structures, which effectively limits the number of ways a given surgical target site can be
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`2
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`accessed. This can be seen, by way of example only, in the spinal arts, where the exiting nerve
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`roots and neural plexus structures in the psoas muscle have rendered a lateral or far lateral access
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`path (so-called trans-psoas approach) to the lumbar spine virtually impossible. Instead, spine
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`surgeons are largely restricted to accessing the spine from the posterior (to perform, among other
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`5
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`procedures, posterior lumbar interbody fusion (PLIF)) or from the anterior (to perform, among
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`other procedures, anterior lumbar interbody fusion (ALIF)).
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`Posterior-access procedures involve traversing a shorter distance within the patient to
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`establish the operative corridor, albeit at the price of oftentimes having to reduce or cut away part
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`10
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`of the posterior bony structures (e.g. lamina, facets, spinous process) in order to reach the target
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`site (which typically comprises the disc space). Anterior-access procedures are relatively simple
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`for surgeons in that they do not involve reducing or cutting away bony stmctures to reach the
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`surgical target site. However, they are nonetheless disadvantageous in that they require
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`traversing through a much greater distance within the patient to establish the operative corridor,
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`15
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`oftentimes requiring an additional surgeon to assist with moving the various internal organs out
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`of the way to create the operative corridor.
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`The present invention is directed at eliminating, or at least minimizing the effects of, the
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`above-identified drawbacks in the prior art.
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`20
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`SUMMARY OF THE INVENTION
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`The present invention accomplishes this goal by providing a novel access system and
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`related methods which involve detecting the existence of (and optionally the distance and/or
`
`direction to) neural structures before, during, and after the establishment of an operative con-idor
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`25
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`through (or near) any of a variety of tissues having such neural structures which, if contacted or
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`impinged, may otherwise result in neural impairment for the patient. It is expressly noted that,
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`although described herein largely in terms of use in spinal surgery, the access system of the
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`present invention is suitable for use in any number of additional surgical procedures wherein
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`tissue having significant neural structures must be passed through (or near) in order to establish
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`30
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`an operative corridor. It is also expressly noted that, although shown and described herein
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`3
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`largely within the context of lateral surgery in the lumbar spine, the access system of the present
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`invention may be employed in any number of other spine surgery access approaches, including
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`but not limited to posterior, postero-lateral, anterior, and antero-lateral access, and may be
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`employed in the lumbar, thoracic and/or cervical spine, all without departing from the present
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`5
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`invention.
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`According to one broad aspect of the present invention, the access system comprises a
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`tissue distraction assembly and a tissue retraction assembly, both of which may be equipped with
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`one or more electrodes for use in detecting the existence of (and optionally the distance and/or
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`10
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`direction to) neural structures. The tissue distraction assembly (in conjunction with one or more
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`elements of the tissue retraction assembly) is capable of, as an initial step, distracting a region of
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`tissue between the skin of the patient and the surgical target site. The tissue retraction assembly
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`is capable of, as a secondary step, being introduced into this distracted region to thereby define
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`and establish the operative corridor. Once established, any of a variety of surgical instruments,
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`15
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`devices, or implants may be passed through and/or manipulated within the operative corridor
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`depending upon the given surgical procedure. The electrode(s) are capable of, during both tissue
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`distraction and retraction, detecting the existence of (and optionally the distance and/or direction
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`to) neural structures such that the operative corridor may be established through (or near) any of a
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`variety of tissues having such neural structures which, if contacted or i~pinged, may otherwise
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`20
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`result in neural impairment for the patient. In this fashion, the access system of the present
`
`invention may be used to traverse tissue that would ordinarily be deemed unsafe or undesirable,
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`thereby broadening the number of manners in which a given surgical target site may be accessed.
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`The tissue distraction assembly may include any number of components capable of
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`25
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`performing the necessary distraction. By way of example only, the tissue distraction assembly
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`may include a K-wire and one or more dilators (e.g., sequentially dilating cannulae) for
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`performing the necessary tissue distraction to receive the remainder of the tissue retractor
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`assembly thereafter. One or more electrodes may be provided on one or more of the K-wire and
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`dilator(s) to detect the presence of (and optionally the distance and/or direction to) neural
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`30
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`structures during tissue distraction.
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`4
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`A TEC _LLI F000849972
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`The tissue retraction assembly may include any number of components capable of
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`performing the necessary retraction. By way of example only, the tissue retraction assembly
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`may include one or more retractor blades extending from a handle assembly. The handle
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`5
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`assembly may be manipulated to open the retractor assembly; that is, allowing the retractor
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`blades to separate from one another (simultaneously or sequentially) to create an operative
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`corridor to the surgical target site. In a preferred embodiment, this is accomplished by
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`maintaining a posterior retractor blade in a fixed position relative to the surgical target site (so as
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`to avoid having it impinge upon any exiting nerve roots near the posterior elements of the spine)
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`10 while the additional retractor blades (i.e. cephalad-most and caudal-most blades) are moved or
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`otherwise translated away from the posterior retractor blade (and each other) so as to create the
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`operative corridor in a fashion that doesn't impinge upon the region of the exiting nerve roots. In
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`one optional aspect of the present invention, the cephalad-most and/or caudal-most blades may
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`pivot or rotate outward from a central axis of insertion, such that the operative corridor may be
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`15
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`further expanded. In a further optional aspect of the present invention, the retractor may include
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`a locking element to maintain the blades in an initial alignment during insertion, and a variable(cid:173)
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`stop mechanism to allow the user to control the degree of expansion of the operative corridor. A
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`blade expander tool may be provided to facilitate manual pivoting of the retractor blades.
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`20
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`The retractor blades may be optionally dimensioned to receive and direct a rigid shim
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`element to augment the structural stability of the retractor blades and thereby ensure the operative
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`corridor, once established, will not decrease or become more restricted, such as may result if
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`distal ends of the retractor blades were permitted to "slide" or otherwise move in response to the
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`force exerted by the displaced tissue. In a preferred embodiment, only the posterior retractor
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`25
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`blade is equipped with such a rigid shim element. In an optional aspect, this shim element may
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`be advanced into the disc space after the posterior retractor blade is positioned, but before the
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`retractor is opened into the fully retracted position. The rigid shim element is preferably oriented
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`within the disc space such that is distracts the adjacent vertebral bodies, which serves to restore
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`disc height. It also preferably advances a sufficient distance within the disc space (preferably
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`30
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`past the midline), which advantageously forms a protective barrier that prevents the migration of
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`5
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`tissue (such as nerve roots) into the operative field and the inadvertent advancement of
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`instruments outside the operative field. In an optional embodiment, the caudal-most and/or
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`cephalad-most blades may be fitted with any number of retractor extenders for extending
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`(laterally or length-wise) the blades, which advantageously forms a protective barrier that
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`5
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`prevents the migration of tissue (such as muscle and soft tissue) into the operative field and the
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`inadvertent advancement of instruments outside the operative field .
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`The retractor blades may optionally be equipped with a mechanism for transporting or
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`emitting light at or near the surgical target site to aid the surgeon's ability to visualize the
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`10
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`surgical target site, instruments and/or implants during the given surgical procedure. According
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`to one embodiment, this mechanism may comprise, but need not be limited to, coupling one or
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`more light sources to the retractor blades such that the terminal ends are capable of emitting light
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`at or near the surgical target site. According to another embodiment, this mechanism may
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`comprise, but need not be limited to, constructing the retractor blades of suitable material (such
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`15
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`as clear polycarbonate) and configuration such that light may be transmitted generally distally
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`through the walls of the retractor blade light to shine light at or near the surgical target site. This
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`may be performed by providing the retractor blades having light-transmission characteristics
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`(such as with clear polycarbonate construction) and transmitting the light almost entirely within
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`the walls of the retractor blade (such as by frosting or otherwise rendering opaque portions of the
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`20
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`exterior and/or interior) until it exits a portion along the interior (or medially-facing) surface of
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`the retractor blade to shine at or near the surgical target site. The exit portion may be optimally
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`configured such that the light is directed towards the approximate center of the surgical target site
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`and may be provided along the entire inner periphery of the retractor blade or one or more
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`portions therealong.
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`25
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`30
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`Many advantages of the present invention will be apparent to those skilled in the art with
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`a reading of this specification in conjunction with the attached drawings, wherein like reference
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`numerals are applied to like elements and wherein:
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`A TEC _LLI F00084997 4
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`Figure 1 is a perspective view of a tissue retraction assembly forming part of a surgical
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`access system according to the present invention, shown in a fully retracted or "open" position;
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`Figs. 2-3 are top and perspective views, respectively, of the tissue retraction assembly of
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`5
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`Fig. 1 shown in a dosed position according to the present invention;
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`Figs. 4-5 are top and perspective views, respectively, of the tissue retraction assembly of
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`Fig. l in an open position;
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`10
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`Figs. 6-7 are perspective views illustrating the front and back of a wide retractor extender
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`for use with any one of the retractor blades according to the retractor of the present invention;
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`Figs. 8-9 are perspective views illustrating the front and back of a narrow retractor
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`extender for use with one of the retractor blades according to the retractor of the present
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`15
`
`invention;
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`Figs. 10-11 are perspective views illustrating the front and back of a shim element for use
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`with a posterior retractor blade of the retractor according to the retractor of the present invention;
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`20
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`Figs. 12-13 are perspective views of the front and back, respectively, of a shim element
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`according to one embodiment of the present invention;
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`Figs. 14-15 are perspective and top views, respectively, of a tissue retraction assembly of
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`according to one embodiment of the present invention, shown in an open position with a shim
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`25
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`and/or retractor extender installed on each retractor blade;
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`Figs. 16-17 are perspective views of an arm member comprising part of the tissue
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`retraction assembly of Fig. 1;
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`30
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`Fig. 18 is a top view of the arm member of Fig. 16;
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`Figs. 19-20 are perspective and top views, respectively, of the arm member of Fig. 16 in
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`which a pivot wrench is coupled with a distal pivot region of the arm member;
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`5
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`Fig. 21 is a perspective view of the arm member of Fig. 19 after the distal pivot region as
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`been pivoted and the locking mechanism has been engaged;
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`Figs. 22-23 are perspective and top views, respectively, of the arm member of Fig. 21 in
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`which the pivot wrench has been removed;
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`10
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`Fig. 24 is a perspective view of the tissue retraction assembly of Fig. 1 in conjunction
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`with a pair of pivot wrenches before the blades have been pivoted;
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`Fig. 25 is a perspective view of the tissue retraction assembly of Fig. 24 after pivoting of
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`15
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`the blades;
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`Fig. 26 is a perspective view of the tissue retraction assembly of Fig. 25, in which the
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`locking mechanisms have been activated;
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`20
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`Figs. 27-28 are perspective and top views, respectively, of the tissue retraction assembly
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`of Fig. 25, in which the cephalad-most and caudal-most blades have been pivoted and the locking
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`mechanisms have been engaged;
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`Figs. 29-30 are side views of a retractor blade expander tool according to one
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`25
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`embodiment of the present invention, shown in initial closed and secondary open positions,
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`respectively;
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`Fig. 31 is a perspective view of a retractor blade expander tool of Fig. 29 inserted into an
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`operative corridor formed by the tissue retraction assembly of Fig. 1 with the blades in a retracted
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`30
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`position;
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`A TEC _LLI F000849976
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`Figs. 32-33 are perspective views of the retractor blade expander tool of Fig. 31 in an
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`open position causing the cephalad-most and caudal-most retractor blades of the tissue retraction
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`assembly of Fig. 31 to pivot in an outward direction;
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`5
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`Figs. 34-35 are side and perspective views, respectively, of a shim inserter according to a
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`preferred embodiment of the present invention;
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`Figs. 36-37 are side and perspective views, respectively, the shim inserter of Fig. 34
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`10
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`coupled to a shim;
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`Figs. 38-39 are side and top views, respectively, of the shim inserter of Fig. 36 prior to
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`insertion of the shim;
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`15
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`Figs. 40-41 are perspective and top views, respectively, of a shim inserter according to
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`the present invention coupled to a shim in the initial phase of insertion, where the shim is
`
`entering the operative corridor at the skin level;
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`Figs. 42-43 are perspective and top views, respectively, of the shim inserter & shim of
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`20
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`FIG. 52, where the shim has been inserted beyond the skin level and fully into the operative
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`corridor;
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`Figs. 44-45 are top and perspective views, respectively, of a fully inse1ted shim, wherein
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`the shim inserter has been removed;
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`25
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`Fig. 46 is a side view illustrating the use of a tissue distraction assembly (comprising a
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`plurality of dilating cannulae over a K-wire) to distract tissue between the skin of the patient and
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`the surgical target site according to the present invention;
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`A TEC _LLI F000849977
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`Fig. 47 is a side view of a retractor assembly according to the present invention,
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`comprising a handle assembly having three (3) retractor blades extending there from (posterior,
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`cephalad-most, and caudal-most), shown in a first, closed position and disposed over the tissue
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`distraction assembly of Fig. 46:
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`Fig. 48 is a side view of a retractor assembly according to the present invention,
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`comprising a handle assembly having three (3) retractor blades extending there from (posterior,
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`cephalad-most, and caudal-most) with the tissue distraction assembly of Fig. 46 removed and
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`shim element introduced;
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`Fig. 49-50 are perspective and top views, respectively, of the retractor assembly in a
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`second, opened (i.e. retracted) position to thereby create an operative corridor to a surgical target
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`site according to the present invention;
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`Figs. 51-52 are perspective views of the retractor assembly of Fig. 50 with the retractor
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`arms in a pivoted position;
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`Fig. 53 is a perspective view of the retractor assembly in the second, opened (i.e.
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`retracted) position (with the secondary distraction assembly removed) and with one retractor
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`extender of Figs. 6-7 coupled to a retractor blade and another retractor being inserted onto a
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`second retractor blade according to the present invention.
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`Figs. 54-55 are perspective views of a handle assembly forming part of the tissue
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`retraction assembly of Fig. 1 shown in an initial closed position;
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`Fig. 56 is a perspective view of the handle assembly of Fig. 54 shown in a secondary open
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`position;
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`A TEC _LLI F000849978
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`Fig. 57 is a perspective view of an exemplary nerve monitoring system capable of
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`perfonning nerve monitoring before, during and after the creating of an operative corridor to a
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`surgical target site using the surgical access system in accordance with the present invention;
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`Fig. 58 is a block diagram of the nerve monitoring system shown in Fig. 57; and
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`Figs. 59-60 are screen displays illustrating exemplary features and information
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`communicated to a user during the use of the nerve monitoring system of Fig. 57.
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`DESCRIPTION OF THE PREFERRED EMBODIMENT
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`Illustrative embodiments of the invention are described below. In the interest of clarity,
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`not all features of an actual implementation are described in this specification. It will of course
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`be appreciated that in the development of any such actual embodiment, numerous
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`implementation-specific decisions must be made to achieve the developers' specific goals, such
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`as compliance with system-related and business-related constraints, which will vary from one
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`implementation to another. Moreover, it will be appreciated that such a development effort
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`might be complex and time-consuming, but would nevertheless be a routine undertaking for
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`those of ordinary skill in the art having the benefit of this disclosure. It is furthermore to be
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`readily understood that, although discussed below primarily within the context of spinal surgery,
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`the surgical access system of the present invention may be employed in any number of
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`anatomical settings to provide access to any number of different surgical target sites throughout
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`the body. It is also expressly noted that, although shown and described herein largely within the
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`context of lateral surgery in the lumbar spine, the access system of the present invention may be
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`employed in any number of other spine surgery access approaches, including but not limited to
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`posterior, postero-lateral, anterior, and antero-lateral access, and may be employed in the lumbar,
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`thoracic and/or cervical spine, all without departing from the present invention. The surgical
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`access system disclosed herein boasts a variety of inventive features and components that wanant
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`patent protection, both individually and in combination.
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`The present invention involves accessing a surgical target site in a fashion less invasive
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`than traditional "open" surgeries and doing so in a manner that provides access in spite of the
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`neural structures required to be passed through (or near) in order to establish an operative
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`c01Tidor to the surgical target site. Generally speaking, the surgical access system of the present
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`invention accomplishes this by providing a tissue distraction assembly and a tissue retraction
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`assembly, both of which may be equipped with one or more electrodes for use in detecting the
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`existence of (and optionally the distance and/or direction to) neural structures.
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`These electrodes are preferably provided for use with a nerve surveillance system such as,
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`by way of example, the type shown and described in the above referenced NeuroVision PCT
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`Applications. GeneraJly speaking, this nerve surveillance system is capable of detecting the
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`existence of (and optionally the distance and/or direction to) neural structures during the
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`distraction and retraction of tissue by detecting the presence of nerves by applying a stimulation
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`signal to such instruments and monitoring the evoked EMG signals from the myotomes
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`associated with the nerves being passed by the distraction and retraction systems of the present
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`invention. In so doing, the system as a whole (including the surgical access system of the present
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`invention) may be used to form an operative corridor through (or near) any of a variety of tissues
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`having such neural structures, particularly those which, if contacted or impinged, may otherwise
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`result in neural impairment for the patient. In this fashion, the access system of the present
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`invention may be used to traverse tissue that would ordinarily be deemed unsafe or undesirable,
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`thereby broadening the number of manners in which a given surgical target site may be accessed.
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`The tissue distraction assembly of the present invention (comprising a K-wire, an initial
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`dilator, and a plurality of sequentially dilating cannulae) is employed to distract the tissues
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`extending between the skin of the patient and a given surgical target site (preferably along the
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`posterior region of the target intervertebral disc). Once distracted, the resulting void or distracted
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`region within the patient is of sufficient size to accommodate a tissue retraction assembly of the
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`present invention. More specifically, the tissue retraction assembly (comprising a plurality of
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`retractor blades extending from a handle assembly) may be advanced relative to the secondary
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`distraction assembly such that the retractor blades, in a first, closed position, are advanced over
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`the exterior of the secondary distraction assembly. At that point. the handle assembly may be
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`operated to move the retractor blades into a second, open or "retracted" position to create an
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`operative corridor to the surgical target site.
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`According to one aspect of the invention, following (or before) this retraction, a posterior
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`shim element (which is preferably slidably engaged with th