U.S. patent application number 15/598880 was filed with the patent office on 2017-09-14 for systems and methods for performing neurophysiologic monitoring during spine surgery.
The applicant listed for this patent is NuVasive, Inc.. Invention is credited to Eric Finley, James Gharib, James Coleman Lee.
Application Number | 20170258315 15/598880 |
Document ID | / |
Family ID | 58708441 |
Filed Date | 2017-09-14 |
United States Patent
Application |
20170258315 |
Kind Code |
A1 |
Gharib; James ; et
al. |
September 14, 2017 |
Systems and Methods for Performing Neurophysiologic Monitoring
During Spine Surgery
Abstract
A surgical access system comprising a tissue retraction assembly
equipped with two or more electrodes for use in monitoring the
status of nearby neural structures, including the localized depth
of neural structures relative to one or more components of the
tissue retraction assembly. Additional neurological testing may be
performed to monitor the health and status of the neural structures
during the portions of the surgical procedure in which the tissue
retraction assembly is used to maintain the operative corridor.
Inventors: |
Gharib; James; (San Diego,
CA) ; Finley; Eric; (Poway, CA) ; Lee; James
Coleman; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NuVasive, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
58708441 |
Appl. No.: |
15/598880 |
Filed: |
May 18, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13761039 |
Feb 6, 2013 |
9655505 |
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15598880 |
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61595625 |
Feb 6, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00039
20130101; A61B 17/02 20130101; A61B 5/04001 20130101; A61B
2017/00407 20130101; A61B 17/0293 20130101; A61B 90/30 20160201;
A61B 17/0206 20130101; A61B 2017/0262 20130101; A61B 1/32 20130101;
A61B 2017/0042 20130101; A61B 2017/00115 20130101; A61B 2017/00907
20130101 |
International
Class: |
A61B 1/32 20060101
A61B001/32 |
Claims
1. A system for creating and maintaining an operative corridor to a
spinal surgical target site, comprising: a retractor assembly
including a retractor body and a plurality of retractor blades
extending generally perpendicularly to the retractor body, the
retractor body being operable to separate the plurality of
retractor blades relative to each other to retract tissue away from
the interior of the retractor blades when the tissue retractor is
advanced to the surgical target site and the retractor blades are
separated to thereby form an operative corridor to the surgical
target site, wherein at least one of the plurality of blades is an
electrode blade configured to couple to an electrode member and an
electrode member removably couplable with said electrode blade, the
electrode member comprising a nonconductive material having a
conductive trace extending a length thereof between a proximal
exposed area and at least two distal exposed areas, the distal
exposed areas comprising electrode contacts configured to at least
one of transmit an electrical stimulation signal to tissue adjacent
the distal portion of the posterior blade and record an evoked
neurophysiologic response.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present invention is a continuation of, and is related
to, co-pending U.S. Non-Provisional patent application Ser. No.
13/761,039, filed Feb. 6, 2013, now U.S. Pat. No. 9,655,505 issued
May 23, 2017, which claims priority under 35 U.S.C. 119(e) from
U.S. Provisional Application Ser. No. 61/595,625 filed Feb. 6,
2012, the complete disclosure of which is hereby incorporated by
reference into this application as if set forth fully herein. The
present application incorporates by reference commonly owned and
co-pending International Patent Application No. PCT/US01/01489,
filed Aug. 8, 2011 and entitled "Surgical Access System and Related
Methods," and commonly owned U.S. Pat. No. 8,255,045, issued Aug.
28, 2012 and entitled "Neurophysiology Monitoring System," the
entire contents of each of which are hereby incorporated by
reference into this disclosure as if set forth fully herein.
FIELD
[0002] This disclosure relates to a surgical retraction system and
related instrumentation and methods for accessing a surgical target
site for the purpose of performing surgical procedures.
BACKGROUND
[0003] The spinal column is a highly complex system of bones and
connective tissues that provide support for the body and protect
the delicate spinal cord and nerves. The spinal column includes a
series of vertebral bodies stacked one atop the other, each
vertebral body including an inner or central portion of relatively
weak cancellous bone and an outer portion of relatively strong
cortical bone. Situated between each vertebral body is an
intervertebral disc that cushions and dampens compressive forces
exerted upon the spinal column. A vertebral canal containing the
spinal cord is located behind the vertebral bodies.
[0004] There are many types of spinal column disorders including
scoliosis (abnormal lateral curvature of the spine), excess
kyphosis (abnormal forward curvature of the spine), excess lordosis
(abnormal backward curvature of the spine), spondylothesis (forward
displacement of one vertebra over another), and other disorders
caused by abnormalities, disease or trauma, such as ruptured or
slipped discs, degenerative disc disease, fractured vertebra and
the like. Patients that suffer from such conditions usually
experience extreme and debilitating pain, as well as diminished
nerve function.
[0005] A noteworthy trend in the medical community is the move away
from performing surgery via traditional "open" techniques in favor
of minimally invasive or minimal access techniques. 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, lengthened hospitalization (increasing health
care costs), and high morbidity in the patient population.
Less-invasive surgical techniques (including so-called "minimal
access" and "minimally invasive" techniques are gaining favor due
to the fact that they involve accessing the surgical target site
via incisions of substantially smaller size with greatly reduced
tissue displacement requirements. This, in turn, reduces the pain,
morbidity, and cost associated with such procedures. One such
minimally invasive approach, a lateral trans-psoas approach to the
spine, developed by NuVasive.RTM., Inc., San Diego, Calif.
(XLIF.RTM.) has demonstrated great success in reducing patient
morbidity, shortening the duration of hospitalization, and speeding
recovery time if it is employed.
[0006] To create the lateral access corridor to the lumbar spine,
the patient is positioned on his or her side and a surgical access
system is advanced through an incision, into the retroperitoneal
space, and then through the psoas muscle until the target spinal
site (for example, a disc space between a pair of adjacent
vertebral bodies) is reached. The surgical access system may
include a sequential dilation assembly of increasing diameter and a
tissue retraction assembly. The sequential dilation assembly is
advanced to the target site first and the retractor assembly is
then advanced to the target site over the sequential dilation
system. Stimulating electrodes may be provided on the distal tip of
one or more of the different components of the surgical access
system. Nerve monitoring may be performed while advancing one or
more components of the dilation and retraction assemblies to the
target site to detect the presence of, and thereby avoid, nerves
lying in the trans-psoas path to the target site.
[0007] Once the retractor assembly has been docked at a target site
however, a nerve situated near any location along the length of a
retractor blade (for example, a center (posterior) blade) might
come into inadvertent contact with the blade which could cause the
nerve to become compressed over the course of the surgical
procedure. As such, information regarding the depth, proximity,
health, and status of nearby nerves during maintenance of a lateral
access corridor is desirable. Because an at-risk nerve may not be
in close proximity to the stimulating electrode on the distal tip
of the retractor blade, larger amounts of stimulation current could
be required to depolarize the nerve and elicit a response, though
it is generally preferable to conduct the monitoring with the least
intense stimulation necessary. Additionally, if a nerve is
compressed, the closer the stimulation signal is delivered to the
nerve the more precise information regarding the health and/or
status of the nerve is likely to be. Furthermore, information
regarding the depth of a nerve during maintenance of the lateral
access corridor is also desirable, because it provides specific
information as to the site of possible compression relative to the
blade.
SUMMARY
[0008] The present disclosure accomplishes this goal by providing a
novel access system and 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 corridor through (or near) any of a variety of tissues
having such neural structures which, if contacted or impinged, may
otherwise result in neural impairment for the patient. It is
expressly noted that, although described herein largely in terms of
use in spinal surgery, the access system of the present disclosure
is suitable for use in any number of additional surgical procedures
wherein tissue having significant neural structures must be passed
through (or near) in order to establish an operative corridor.
[0009] According to one broad aspect of the present disclosure, the
access system comprises a tissue distraction assembly 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. The tissue
distraction assembly (in conjunction with one or more elements of
the tissue retraction assembly) is capable of, as an initial step,
distracting a region of tissue between the skin of the patient and
the surgical target site. The tissue retraction assembly is capable
of, as a secondary step, being introduced into this distracted
region to thereby define and establish the operative corridor. Once
established, any of a variety of surgical instruments, devices, or
implants may be passed through and/or manipulated within the
operative corridor depending upon the given surgical procedure. The
electrode(s) are capable of, during both tissue distraction and
retraction, detecting the existence of (and optionally the distance
and/or direction to) neural structures such that the operative
corridor may be established through (or near) any of a variety of
tissues having such neural structures which, if contacted or
impinged, may otherwise result in neural impairment for the
patient. In this fashion, the access system of the present
disclosure may be used to traverse tissue that would ordinarily be
deemed unsafe or undesirable, thereby broadening the number of
manners in which a given surgical target site may be accessed.
[0010] The tissue distraction assembly may include any number of
components capable of performing the necessary distraction. By way
of example only, the tissue distraction assembly may include a
K-wire and one or more dilators (e.g., sequentially dilating
cannulae) for performing the necessary tissue distraction to
receive the remainder of the tissue retractor assembly thereafter.
One or more electrodes may be provided on one or more of the K-wire
and dilator(s) to detect the presence of (and optionally the
distance and/or direction to) neural structures during tissue
distraction.
[0011] The tissue retraction assembly may include any number of
components capable of performing the necessary retraction. By way
of example only, the tissue retraction assembly may include one or
more retractor blades extending from a handle assembly. The handle
assembly may be manipulated to open the retractor assembly; that
is, allowing the retractor blades to separate from one another
(simultaneously or sequentially) to create an operative corridor to
the surgical target site. In a preferred embodiment, this is
accomplished by maintaining a posterior retractor blade in a fixed
position relative to the surgical target site (so as to avoid
having it impinge upon any exiting nerve roots near the posterior
elements of the spine) while the additional retractor blades (i.e.
cephalad-most and caudal-most blades) are moved or otherwise
translated away from the posterior retractor blade (and each other)
so as to create the operative corridor in a fashion that doesn't
impinge upon the region of the exiting nerve roots. In one optional
aspect of the present disclosure, the cephalad-most and/or
caudal-most blades may pivot or rotate outward from a central axis
of insertion, such that the operative corridor may be further
expanded. In a further optional aspect of the present disclosure,
the retractor may include a locking element to maintain the blades
in an initial alignment during insertion, and a variable-stop
mechanism to allow the user to control the degree of expansion of
the operative corridor. A blade expander tool may be provided to
facilitate manual pivoting of the retractor blades.
[0012] The retractor blades may be optionally dimensioned to
receive and direct a locking shim element to augment the structural
stability of the retractor blades and thereby ensure the operative
corridor, once established, will not decrease or become more
restricted, such as may result if distal ends of the retractor
blades were permitted to "slide" or otherwise move in response to
the force exerted by the displaced tissue. In a preferred
embodiment, only the posterior retractor blade is equipped with
such a rigid shim element. In an optional aspect, this shim element
may be advanced into the disc space after the posterior retractor
blade is positioned, but before the retractor is opened into the
fully retracted position. The rigid shim element is preferably
oriented within the disc space such that is distracts the adjacent
vertebral bodies, which serves to restore disc height. It also
preferably advances a sufficient distance within the disc space
(preferably past the midline), which advantageously forms a
protective barrier that prevents the migration of tissue (such as
nerve roots) into the operative field and the inadvertent
advancement of instruments outside the operative field. In an
optional embodiment, the caudal-most and/or cephalad-most blades
may be fitted with any number of retractor extenders for extending
(laterally or length-wise) the blades, which advantageously forms a
protective barrier that prevents the migration of tissue (such as
muscle and soft tissue) into the operative field and the
inadvertent advancement of instruments outside the operative
field.
[0013] The retractor blades may optionally be equipped with a
mechanism for transporting or emitting light at or near the
surgical target site to aid the surgeon's ability to visualize the
surgical target site, instruments and/or implants during the given
surgical procedure. According to one embodiment, this mechanism may
comprise, but need not be limited to, coupling one or more light
sources to the retractor blades such that the terminal ends are
capable of emitting light at or near the surgical target site.
According to another embodiment, this mechanism may comprise, but
need not be limited to, constructing the retractor blades of
suitable material (such as clear polycarbonate) and configuration
such that light may be transmitted generally distally through the
walls of the retractor blade light to shine light at or near the
surgical target site. This may be performed by providing the
retractor blades having light-transmission characteristics (such as
with clear polycarbonate construction) and transmitting the light
almost entirely within the walls of the retractor blade (such as by
frosting or otherwise rendering opaque portions of the exterior
and/or interior) until it exits a portion along the interior (or
medially-facing) surface of the retractor blade to shine at or near
the surgical target site. The exit portion may be optimally
configured such that the light is directed towards the approximate
center of the surgical target site and may be provided along the
entire inner periphery of the retractor blade or one or more
portions therealong.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Many advantages of the present disclosure will be apparent
to those skilled in the art with a reading of this specification in
conjunction with the attached drawings, wherein like reference
numerals are applied to like elements and wherein:
[0015] FIG. 1 is a perspective view of one example of a tissue
retraction assembly forming part of a surgical access system
according to one embodiment of the present disclosure, shown in a
fully retracted or "open" position;
[0016] FIG. 2 is a perspective view of the tissue retraction
assembly of FIG. 1 shown in a fully closed position;
[0017] FIG. 3 is a perspective view of the tissue retraction
assembly of FIG. 1 shown in a partially open position according to
the present disclosure;
[0018] FIGS. 4-5 are front perspective and back perspective views,
respectively, of one example of a locking shim forming part of the
surgical access system of the present disclosure;
[0019] FIG. 6 is a top view of the locking shim of FIG. 4;
[0020] FIG. 7 is a side plan view of a tissue distraction assembly
(comprising a plurality of dilating cannulae over a K-wire) used to
distract tissue between the skin of the patient and the surgical
target site according to one embodiment of the present
disclosure;
[0021] FIGS. 8-9 are side and perspective views, respectively, of
an example of a disposable electrode forming part of the tissue
retraction system of FIG. 1 according to one embodiment of the
present disclosure;
[0022] FIGS. 10-11 are perspective views of an example of a
retractor blade forming part of the tissue retraction system of
FIG. 1 configured to releasably couple with the disposable
electrode of FIG. 9;
[0023] FIG. 12 is top perspective view of the retractor blade of
FIG. 10;
[0024] FIGS. 13-14 are perspective views of an assembly comprising
the disposable electrode of FIG. 8 coupled to the retractor blade
of FIG. 10;
[0025] FIGS. 15-16 are perspective views of the tissue retraction
assembly of FIG. 1 including the disposable electrode/blade
assembly of FIG. 13;
[0026] FIGS. 17-18 are perspective views of an example of an
insulated locking shim for use with the posterior blade forming
part of the tissue retraction system of FIG. 1 to prevent current
shunting from the posterior blade when neurophysiologic monitoring
is performed from the posterior blade;
[0027] FIGS. 19-20 are perspective views of an alternative example
of an electrode body with multiple electrode contacts at the distal
end removably coupled to a retractor blade, forming part of the
tissue retraction system of FIG. 1;
[0028] FIGS. 21-24 are perspective views of another alternative
example of an electrode body with a single electrode at the distal
end that is movable within, and removably couplable to, a retractor
blade, forming part of the tissue retraction system of FIG. 1;
[0029] FIG. 25 is a perspective view of an example of a retractor
blade having multiple electrode contacts at the distal end, forming
part of the tissue retraction system of FIG. 1;
[0030] FIG. 26 is a perspective view of an example of a posterior
shim element having multiple electrode contacts, the posterior shim
element couplable to a retractor blade forming part of the tissue
distraction system of FIG. 1;
[0031] FIG. 27 is a perspective view of the posterior shim element
of FIG. 26 coupled with a retractor blade forming part of the
tissue distraction system of FIG. 1;
[0032] FIGS. 28-29 are perspective views of one example of a
locking intradiscal shim having electrode contacts are the distal
end and coupled to a retractor blade forming part of the tissue
retraction system of FIG. 1;
[0033] FIG. 30 is a perspective view of an example of a nerve
monitoring system programmed to perform nerve monitoring before,
during and after the creation of an operative corridor to a
surgical target site using the surgical access system of FIG. 1 in
accordance with the present disclosure;
[0034] FIG. 31 is a block diagram of the nerve monitoring system
shown in FIG. 30; and
[0035] FIGS. 32-33 are examples of screen displays illustrating
exemplary features and information communicated to a user during
the use of the nerve monitoring system of FIG. 30.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0036] Illustrative embodiments of the disclosure are described
below. In the interest of clarity, not all features of an actual
implementation are described in this specification. It will of
course be appreciated that in the development of any such actual
embodiment, numerous implementation-specific decisions must be made
to achieve the developers' specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming, but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of this
disclosure. It is furthermore to be readily understood that,
although discussed below primarily within the context of spinal
surgery, the surgical access system of the present disclosure may
be employed in any number of anatomical settings to provide access
to any number of different surgical target sites throughout the
body. It is also expressly noted that, although shown and described
herein largely within the context of lateral surgery in the lumbar
spine, the access system of the present disclosure may be employed
in any number of other spine surgery access approaches, including
but not limited to posterior, postero-lateral, anterior, and
antero-lateral access, and may be employed in the lumbar, thoracic
and/or cervical spine, all without departing from the present
disclosure. The surgical access system disclosed herein boasts a
variety of inventive features and components that warrant patent
protection, both individually and in combination.
[0037] The present disclosure involves accessing a surgical target
site in a fashion less invasive than traditional "open" surgeries
and doing so in a manner that provides access in spite of the
neural structures required to be passed through (or near) in order
to establish an operative corridor to the surgical target site.
Generally speaking, the surgical access system of the present
disclosure accomplishes this by providing a tissue distraction
assembly 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.
[0038] These electrodes are preferably provided for use with a
nerve surveillance system such as, by way of example, the type
shown and described in the above referenced '045 patent. Generally
speaking, this nerve surveillance system is capable of detecting
the existence of (and optionally the distance and/or direction to)
neural structures during the distraction and retraction of tissue
by detecting the presence of nerves by applying a stimulation
signal to such instruments and monitoring the evoked EMG signals
from the myotomes associated with the nerves being passed by the
distraction and retraction systems of the present disclosure. In so
doing, the system as a whole (including the surgical access system
of the present disclosure) may be used to form an operative
corridor through (or near) any of a variety of tissues having such
neural structures, particularly those which, if contacted or
impinged, may otherwise result in neural impairment for the
patient. In this fashion, the access system of the present
disclosure may be used to traverse tissue that would ordinarily be
deemed unsafe or undesirable, thereby broadening the number of
manners in which a given surgical target site may be accessed.
[0039] Additionally, the neuromonitoring system may perform
neuromonitoring as the retractor assembly is used to maintain the
lateral access corridor as the target site is operated on. Such
monitoring may be used to localize the depth of the nearby nerves
relative to the length of a one or more blade and monitor the
health and status of the nerves in closest proximity to that blade
(or blades). As will be described in greater detail below, the
retraction assembly of the surgical access system may be configured
to: (1) localize the depth of nearby neural structures relative to
one or more of the blades; (2) optimize a stimulating and/or
recording location relative to one or more of the blades; (3)
perform evoked EMG monitoring on the nerve or nerves in closest
proximity to the blades; and (4) perform evoked sensory monitoring
on the nerves in closest proximity to the blades. Aspects of the
neuromonitoring systems used to facilitate performance of these
functions are also described in the following commonly owned patent
applications, collectively referred to as the "Neuromonitoring PCT
Applications," the entire contents of each of which are hereby
incorporated by reference as if set forth fully herein: U.S. Pat.
No. 8,068,912, entitled "System and Methods for Determining Nerve
Proximity, Direction, and Pathology During Surgery," filed on Jan.
9, 2004; U.S. Pat. No. 7,522,953, entitled "System and Methods for
Performing Surgical Procedures and Assessments," filed on Mar. 25,
2004; U.S. Pat. No. 7,905,840, entitled Surgical Access System and
Related Methods," filed Oct. 18, 2004; and U.S. Pat. No. 8,255,045,
entitled "Neurophysiologic Monitoring System," filed on Apr. 4,
2008,
[0040] The tissue distraction assembly of the present disclosure,
including a plurality of sequential dilators and a k-wire, is
employed to distract the tissues extending between the skin of the
patient and a given surgical target site (preferably along the
posterior region of the target intervertebral disc). Once
distracted, the resulting void or distracted region within the
patient is of sufficient size to accommodate a tissue retraction
assembly of the present disclosure. More specifically, the tissue
retraction assembly (comprising a plurality of retractor blades
extending from a handle assembly) may be advanced, with the blades
in a first generally closed position, over the exterior of the
outer dilator. At that point, the handle assembly may be operated
to move the retractor blades into a second, open or "retracted"
position to create an operative corridor to the surgical target
site.
[0041] According to one aspect of the disclosure, following (or
before) this retraction, a posterior shim element (which is
preferably slidably engaged with the posterior retractor blade) may
be advanced such that a distal shim extension is positioned within
the posterior region of the disc space. If done before retraction,
this helps ensure that the posterior retractor blade will not move
posteriorly during the retraction process, even though the other
retractor blades (e.g. cephalad-most and caudal-most) are able to
move and thereby create an operative corridor. Fixing the posterior
retractor blade in this fashion serves several important functions.
First, the distal end of the shim element serves to distract the
adjacent vertebral bodies, thereby restoring disc height. It also
rigidly couples the posterior retractor blade in fixed relation
relative to the vertebral bodies. The posterior shim element also
helps ensure that surgical instruments employed within the
operative corridor are incapable of being advanced outside the
operative corridor, preventing inadvertent contact with the exiting
nerve roots during the surgery. Once in the appropriate retracted
state, the cephalad-most and caudal-most retractor blades may be
locked in position and, thereafter, retractor extenders advanced
therealong to prevent the ingress or egress of instruments or
biological structures (e.g. nerves, vasculature, etc.) into or out
of the operative corridor. Optionally, the cephalad-most and/or
caudal-most retractor blades may be pivoted in an outward direction
to further expand the operative corridor. Once the operative
corridor is established, any of a variety of surgical instruments,
devices, or implants may be passed through and/or manipulated
within the operative corridor depending upon the given surgical
procedure.
[0042] FIGS. 1-3 illustrate a tissue retraction assembly 10 forming
part of a surgical access system according to the present
disclosure, including a plurality of retractor blades 12, 16, 18
extending from a handle assembly 20. By way of example only, the
handle assembly 20 is provided with a first retractor blade 12, a
second retractor blade 16, and a third retractor blade 18. FIG. 1
illustrates the tissue retraction assembly 10 in a fully retracted
or "open" configuration, with the retractor blades 12, 16, 18
positioned a distance from one another so as to form an operative
corridor 15 therebetween which extends to a surgical target site
(e.g. an annulus of an intervertebral disc). In an important aspect
of the present disclosure, the blades 16, 18 are capable of being
pivoted or rotated relative to the handle 20, as best appreciated
with combined reference to FIGS. 1 & 2. FIG. 2 shows the tissue
retraction assembly 10 in an initial "closed" configuration, with
the retractor blades 12, 16, 18 generally abutting one another.
FIG. 3 shows the tissue retraction assembly 10 in a "partially
open" configuration. Although shown and described below with regard
to the three-fixed-bladed configuration, it is to be readily
appreciated that the number of retractor blades may be increased or
decreased without departing from the scope of the present
disclosure. Moreover, although described and shown herein with
reference to a generally lateral approach to a spinal surgical
target site (with the first blade 12 being the "posterior" blade,
the second blade 16 being the "cephalad-most" blade, and the third
blade 18 being the "caudal-most" blade), it will be appreciated
that the tissue retraction assembly 10 of the present disclosure
may find use in any number of different surgical approaches,
including generally posterior, generally postero-lateral, generally
anterior and generally antero-lateral.
[0043] The handle assembly 20 may be coupled to any number of
mechanisms for rigidly registering the handle assembly 20 in fixed
relation to the operative site, such as through the use of an
articulating arm mounted to the operating table (not shown). The
handle assembly 20 includes first and second arm members 26, 28
hingedly coupled via coupling mechanism shown generally at 30. The
second retractor blade 16 is rigidly coupled (generally
perpendicularly) to the end of the first arm member 26. The third
retractor blade 18 is rigidly coupled (generally perpendicularly)
to the end of the second arm member 28. The first retractor blade
12 is rigidly coupled (generally perpendicularly to) a translating
member 17, which is coupled to the handle assembly 20 via a linkage
assembly shown generally at 14. The linkage assembly 14 includes a
roller member 34 having a pair of manual knob members 36 which,
when rotated via manual actuation by a user, causes teeth 35 on the
roller member 34 to engage within ratchet-like grooves 37 in the
translating member 17. Thus, manual operation of the knobs 36
causes the translating member 17 to move relative to the first and
second arm members 26, 28.
[0044] Through the use of handle extenders 31, 33, the arms 26, 28
may be simultaneously opened such that the second and third
retractor blades 16, 18 move away from one another. In this
fashion, the dimension and/or shape of the operative corridor 15
may be tailored depending upon the degree to which the translating
member 17 is manipulated relative to the arms 26, 28. That is, the
operative corridor 15 may be tailored to provide any number of
suitable cross-sectional shapes, including but not limited to a
generally circular cross-section, a generally ellipsoidal
cross-section, a generally triangular cross-section, and/or an oval
cross-section. Optional light emitting devices (not shown) may be
coupled to one or more of the retractor blades 12, 16, 18 to direct
light down the operative corridor 15.
[0045] The retractor blades 12, 16, 18 may be composed of any
material suitable for introduction into the human body, including
but not limited to aluminum, titanium, and/or clear polycarbonate,
that would ensure rigidity during tissue distraction. The retractor
blades 12, 16, 18 may be optionally coated with a carbon fiber
reinforced coating to increase strength and durability. The
retractor blades 12, 16, 18 may be optionally constructed from
partially or wholly radiolucent materials (e.g. aluminum, PEEK,
carbon-fiber, and titanium) to improve the visibility of the
surgeon during imaging (e.g. radiographic, MRI, CT, fluoroscope,
etc.). The retractor blades 12, 16, 18 may be provided in any
number of suitable lengths, depending upon the anatomical
environment and surgical approach, such as (for example) the range
from 20 mm to 150 mm. Based on this range of sizes, the tissue
retraction assembly 10 of the present disclosure is extremely
versatile and may be employed in any of a variety of desired
surgical approaches, including but not limited to lateral,
posterior, postero-lateral, anterior, and antero-lateral, by simply
selecting the desired size retractor blades 12, 16, 18 and
attaching them to the handle assembly 20 as will be described
herein.
[0046] The retractor blades 12, 16, 18 may be equipped with various
additional features or components. By way of example only, one or
more of the retractor blades 12, 16, 18 may be equipped with a
shim, such as a locking shim 56 as shown in FIGS. 4-6. In a
preferred embodiment, the intradiscal locking shim 56 is suitable
for engagement with the posterior blade 12. However, it should be
noted that any shim 56 may be used with any blade 12, 16, 18
without departing from the scope of the present disclosure. The
locking intradiscal shim 56 has a distal tapered region 58 which
may be advanced into the disc space for the purpose of distracting
the adjacent vertebral bodies (thereby restoring disc height)
and/or anchoring the blade 12 relative to the spine. The locking
intradiscal shim 56 also forms a protective barrier to prevent the
ingress or egress of instruments or biological structures (e.g.
nerves, vasculature, etc.) into or out of the operative corridor
15. The locking intradiscal shim 56 locks in position on the
retractor blade 12 to prevent the shim from dislodging and allowing
the retractor to move from the targeted location. To lock position
on the blade, the shim 56 has a flexible engagement tab 60 with a
ramped leading edge 62 that allows it to advance down indentations
63 on the inner surface of the retractor blade 12 (FIG. 11). The
trailing edge 64 of the engagement tab 60 is squared to prevent
disengagement (thus preventing unwanted backout of the shim) from
the indentation 63 without use of a removal tool (not shown). The
engagement tab 60 also includes a T-shaped removal lip 66
configured to engage a shim removal tool, an example of which is
shown and described in PCT App. No. PCT/US01/01489 (incorporated by
reference). The T-shaped lip 66 of the engagement tab 60 allows the
removal tool to lift the trailing edge 64 away from the retractor
blade 12 and remove the shim 56. The locking intradiscal shim 56
has a pair of elongated tab members 68 that are configured to
slideably engage elongated slot members 65 that run the length of
the inside surface of the retractor blade 12 (FIG. 11). The locking
intradiscal shim 56 includes a dimple or aperture 56 located near
the proximal end of the shim 56 configured for engagement with a
shim removal tool.
[0047] The locking intradiscal shim 56 may be made from any
material suitable for use in the human body, including but not
limited to biologically compatible plastic and/or metal, preferably
partially or wholly radiolucent in nature material (such as
aluminum, PEEK, carbon-fibers and titanium). The intradiscal shim
56 may also be coated with an insulative coating (e.g. a parylene
coating) to prevent current shunting or density changes from
electrodes situated at the distal end of the retractor blade 12.
The shim element 56 may be composed of a material that would
destruct when autoclaved (such as polymer containing a portion of
glass particles), which may be advantageous in preventing the
unauthorized re-use of the shim element 56 (which would be provided
to the user in a sterile state).
[0048] According to the present disclosure, the locking intradiscal
shim 56 may be provided with one or more electrodes (e.g. at or
near their distal regions) equipped for use with a neuromonitoring
system. Such a neuromonitoring system may be capable of detecting
the existence of (and optionally the distance and/or direction to)
neural structures during the retraction of tissue by detecting the
presence of nerves by applying a stimulation signal to the
electrodes and monitoring the evoked EMG signals from the myotomes
associated with the nerves in the vicinity of the tissue retraction
system 10 of the present disclosure. In so doing, the system as a
whole (including the tissue retraction system 10 of the present
disclosure) may be used to form an operative corridor through (or
near) any of a variety of tissues having such neural structures,
particularly those that, if contacted or impinged, may otherwise
result in neural impairment for the patient. In this fashion, the
access system of the present disclosure may be used to traverse
tissue that would ordinarily be deemed unsafe or undesirable,
thereby broadening the number of manners in which a given surgical
target site may be accessed.
[0049] As mentioned above, a nerve monitoring system may be
provided for use with the tissue retraction assembly. According to
one example, the nerve monitoring component of the retractor system
is the posterior retractor blade 12, which may be made of a
conductive material (e.g. aluminum) and coated with a insulative
coating to direct stimulation from the nerve monitoring system to
the tissue adjacent the distal end. According to another example
embodiment, pictured in FIGS. 8-16, the neuromonitoring feature of
the tissue retraction assembly includes two main components: a
center (posterior) blade that forms part of a tissue retraction
assembly 10 and an electrode body 70. For example, the electrode
body 70 shown and described is slideably coupled to the posterior
blade 12. By way of further example, the electrode body 70 shown is
disposable. A clip cable 72 may be used to connect the electrode
body 70 to the neuromonitoring system. One potential advantage of
the electrode body 70 and accompanying posterior blade 12 is the
increased ability to attain consistent and repeatable
neuromonitoring functionality throughout the course of a single
surgery and from surgery to surgery (since there is no risk of
erosion of the insulative coating on the blade which can lead to
current shunting).
[0050] FIG. 7 illustrates an example of a tissue distraction system
40 according to one embodiment. The tissue distraction system 40
includes a K-wire 42 and initial dilator 44, as well as a secondary
dilation assembly 50. The secondary dilation assembly 50 includes
at least two nesting cannulae 52, 54.
[0051] FIGS. 8-16 illustrate an example of one embodiment of a
removably couplable disposable electrode 70 and retractor blade 12
for use with the tissue retraction assembly 10 according to the
present disclosure. The electrode 70 assists in the detection of
the depth of nerves relative to the length of the posterior blade
after the tissue retraction assembly is placed. The electrode 70
also assists in assessing the health and status of the nerves
closest to the posterior blade 12 after the tissue retractor 10 is
fully retracted in the open position and throughout the surgical
procedure. (Open position refers to the level of retraction
utilized to maintain the operative corridor to the spine during
surgery.) Using a disposable electrode 70 permits the retractor
blade 12 to be sterilized and reused endlessly without the
possibility of degradation to the electrode. This in turn ensures
that results from nerve monitoring using the electrode are
consistent and reduces potentially high costs of replacing the
entire blade structure if the electrode (or insulating regions
surrounding the electrode) degrade. Although FIG. 15 illustrates
the electrode 70 in use with only the posterior retractor blade 12,
the electrode 70 could be used with each of the retractor blades
12, 16, and/or 18 without departing from the scope of this
disclosure.
[0052] FIGS. 8-9 illustrate one example of an electrode 70 that
includes a molded plastic part with a conductive trace 74 deposited
generally along the length of the electrode 70. The conductive
trace 74 may include a discrete trace for each electrode contact 76
on the electrode body 70. Preferably, the electrode 70 is made out
of a generally stiff material that can also withstand bending
without breaking, such as, for example, PVC. The conductive trace
74 provides a conductive pathway for the delivery of current from a
current delivery source (such as a clip cable 72) to each electrode
as well as for the delivery of electrical activity from nerve
tissue at or near the surgical site to the neuromonitoring system.
There are at least two areas along the electrode body 70 where the
conductive trace 74 is exposed for enabling the delivery of current
to and from the electrode 70. The proximal end of the electrode 70
has a first exposed area 78 that may wrap around the circumference
of the proximal end of the electrode 70 to ensure a conductive path
between the electrode 70 and a current delivery device or a current
recording device (such as, for example, a clip cable 72). The first
exposed area 78 can act as a stimulation conduit and allow a
current delivery source to deliver an electric current to the
conductive trace 74 and as a recording conduit that transmits
changes in electrical current from the conductive trace 74 to the
control unit 172 of the neuromonitoring system. The distal end of
the electrode 70 has at least one electrode contact 76 (shown by
way of example as a triangular patch) within the conductive trace
74 that can act as a stimulation conduit and allow the emitting of
current to nearby tissue and as a recording conduit for recording
changes in electrical current from nearby tissue. Both functions of
the first exposed area 78 and distal electrode contact 76 will be
explained in greater detail below. Other than the exposed areas 76,
78, the remainder of the conductive trace 74 is insulated with a
dielectric coating to prevent current shunting. Any number of
conductive materials suitable for completing the current pathway,
such as, for example, silver, or copper may be used in the
conductive trace 74 without departing from the scope of this
disclosure.
[0053] The first exposed area 78 of the disposable electrode may
have a generally cylindrical shape for facilitating the connection
between the electrode and a neuromonitoring system. For example, as
shown in FIGS. 15-16, an electrical coupler is shown in the form of
a plunger-style clip cable 72. Although shown as cylindrical, the
connection site for a current delivery device or a current
recording device (such as the clip cable 72) may be any size and
shape necessary for making a quality electrical connection without
departing from the scope of the current disclosure. The remainder
of the body of the electrode 70 may be generally flat with minimal
thickness and a variety of features for engaging and securing the
electrode 70 to a retractor blade 12. For example, wings 80 may
extend from the sides of the electrode 70 for engaging positioning
features within the retractor blade 12, as will be discussed in
more detail below. Additionally, the distal end of the electrode 70
may have a ledge 82 for engaging a feature of the retractor blade
12 for further secure positioning of the electrode 70 relative to
the retractor blade 12, as will also be discussed in more detail
below. A single sized electrode 70 may be designed for use with a
variety of retractor blade 12 sizes and shapes (for example,
retractor blade lengths generally ranging from 20 to 180 mm), but
the electrodes may also be available in a variety of shapes and
sizes.
[0054] FIGS. 13-14 illustrate one example assembly of an electrode
70 releasably coupled to retractor blade 12. Preferably, at least
the posterior blade 12 is configured to enable the coupling of an
electrode body 70. During assembly of the electrode body 70 to the
retractor blade 12, the proximal end of the electrode 70 (more
specifically, adjacent the first exposed area 78 end of the
electrode 70) is inserted into generally the distal end of the
retractor blade 12. The wings 80 of the electrode 70 mate with and
are constrained by the dovetail grooves 84 which extend
longitudinally from the distal end to the proximal end of the
retractor blade 12. The dovetail grooves 84 provide an insertion
guide for the disposable electrode 70 as it is inserted and assists
in maintaining proper positioning of the electrode 70 while coupled
to the retractor blade 12. Additionally, the ledge 82 near the
distal end of the disposable electrode 70 may engage the cut-out 86
generally near the distal end of the retractor blade 12 to further
assist in securing the positioning of the electrode 70 relative to
the retractor blade 12. Therefore, the electrode 70 is adapted to
the retractor blade 12 so that the electrode contact 76 (shown by
way of example as triangular in FIGS. 9 and 13) is exposed
generally along the outer surface of the blade (best shown in FIG.
13). Furthermore, the proximal end of the electrode body 70
protrudes from a machined cavity 88 (best shown in FIG. 12) at the
proximal end of the retractor blade 12. Depending on the height of
the blade, the proximal end may be bent or folded so as not to
obstruct the surgical corridor.
[0055] FIG. 17 is illustrates a locking intradiscal shim 83
according to a second example embodiment. The locking intradiscal
shim 83 is similar to the shim 56 of FIGS. 4-6 such that a
description of all the like elements will not be repeated here. The
locking intradiscal shim 83 of FIG. 17 is preferably coated with an
insulative parylene coating to mitigate current shunting and
changes to current density at the distal tip of the disposable
electrode. Parylene is the trade name for a variety of chemical
vapor deposited poly (p-xylylene) polymers used as moisture
barriers and electrical insulators. Among such polymers, Parylene C
is highly desirable due to its combination of barrier properties
and manufacturing advantages. The locking intradiscal shim 83
includes a deflectable tab 85 with a lip member 87 that serves as a
locking feature. The shim 83 further includes a cut-out 89 that
receives an engagement tab of a removal tool.
[0056] Any combination of the features described herein may be
employed at any one time without departing from the scope of the
present disclosure. For example, FIG. 18 illustrates the locking
intradiscal shim 83 of FIG. 17 attached adjacent to the distal end
of the disposable electrode 70 that is removably coupled to the
posterior blade 12 described in relation to FIGS. 9-16 above. By
coupling these several features, each of which include parylene
coating to control shunting of electric current, better results can
be achieved.
[0057] FIGS. 19-20 illustrate an alternative example of a removably
couplable electrode body 90 and retractor blade 12 for use with the
tissue retraction assembly 10. The electrode body 90 is similar in
form to electrode body 70 described above with reference to FIGS.
8-16. The electrode body 90 of the present embodiment includes a
molded plastic part with a conductive trace 94 deposited generally
along the length of the electrode 90. The conductive trace 94
includes a discrete trace for each electrode contact 96 on the
electrode body 90. Preferably, the electrode 90 is made out of a
generally stiff material that can also withstand bending without
breaking, such as, for example, PVC. The conductive trace 94
provides a conductive pathway for the delivery of current from a
current delivery source to each electrode as well as for the
delivery of electrical activity from nerve tissue at or near the
surgical site to the neuromonitoring system. The proximal end of
the electrode 90 has a multi-contact pad 99 that mates with a
complimentary multi-contact coupler (not show) to provide a
conductive path between the electrode 90 and a current delivery
device or a current recording device (such as, for example, a clip
cable 72). The multi-contact pad 99 can act as a stimulation
conduit and allow a current delivery source to deliver an electric
current to each discrete trace of the conductive trace 94 and as a
recording conduit that transmits changes in electrical current from
each electrode region 96 along the associated discrete trace of the
conductive trace 94 to the control unit 172 of the neuromonitoring
system. The distal end of the electrode body 90 has multiple
electrode contacts 96 positioned along the length of the conductive
trace 94, each one associated with a discrete trace of the
conductive trace 94 that act as a stimulation conduits to allow the
emitting of current to nearby tissue and as recording conduits for
recording changes in electrical current from nearby tissue. FIG. 19
depicts six circular electrode contacts 96 in the conductive trace
94 spaced equidistantly along the length of the portion of the
electrode body 90 that engages within the retractor blade 12.
However, any number of electrode contacts 96 may be placed at any
interval along any length of the engaged portion of the electrode
body 90. The electrode body 90 is adapted to the retractor blade 12
so that the electrode contacts 96 are exposed generally along the
outer surface of the blade 12. Other than the exposed areas 96, 98,
the remainder of the conductive trace 94 is insulated with a
dielectric coating to prevent current shunting. Any number of
conductive materials suitable for completing the current pathway,
such as, for example, silver, or copper may be used in the
conductive trace 94 without departing from the scope of this
disclosure. All other features of the electrode body 90, including
but not limited to engagement with the retractor blade 12, are
identical in form and function to the features described in
relation to electrode body 70.
[0058] FIGS. 21-24 illustrate an example of another embodiment of
an electrode body 100 and retractor blade 12 for use with the
tissue retraction assembly. The electrode body 100 of this
embodiment shares many features as the electrode body 90 of FIGS.
19-20 such that common features will not be repeated. However, in
this embodiment, it is noted that there is only one electrode
contact 106 at the distal end of the conductive trace 104.
Furthermore, there is no ledge at the distal end for secured
positioning relative to the distal end of the retractor blade 12.
The dovetailed grooves 107 of the retractor blade 12 are preferably
sized and dimensioned so that the wings on the sides of the
electrode body 100 may slide smoothly along the length of the
retractor blade 12 via the dovetailed grooves 107. According to
some implementations, the electrode body 100 may be movable within
the retractor blade 12 such that an ideal positioning for the
electrode body 100 may be found at one of several locations along
the length of the retractor blade 12. Once this optimal position is
found, it may be kept in place by one or more securing features. By
way of example only, the proximal end may be bent or folded.
Alternatively, the proximal end may be locked into position using a
locking means (including but not limited to a cam lock, clamp,
ramp, push-button, and spring-loaded button). Also, there may be a
series of indentations along the inside of the dovetailed grooves
107 that correspond to protrusions on the wings such that the
electrode body advances through a series of discrete positions
within the dovetailed grooves 107 and stops at the desired
location. Also, the distal end of the retractor blade 12 may
include one or more advancement restriction features 109 that
prevent the electrode body 100 from extending past the distal tip
of the retractor blade 12. By way of example only, FIGS. 21-22
illustrate the electrode body 100 coupled with the retractor blade
12 in the proximal-most position (e.g. no advancement), and FIGS.
23-24 illustrate the electrode body 100 coupled with the retractor
blade 12 in the distal-most position (e.g. maximum
advancement).
[0059] FIG. 25 illustrates another exemplary embodiment. The
retractor blade 12 and electrode area of this embodiment shares
many features as the electrode body of FIGS. 19-20 such that common
features will not be repeated. However, in this embodiment, the
posterior face 110 of the posterior blade 12 includes a conductive
trace 112 extending longitudinally therealong. The conductive trace
112 provides a conductive pathway for the delivery of current from
a current delivery source to the retractor blade 12 itself as well
as for the delivery of electrical activity from nerve tissue at or
near the surgical site to the neuromonitoring device. The posterior
face 110 of the retractor blade 12 has at least one electrode
contact 114 within the conductive trace 110 and this at least one
electrode contact 114 can act as a stimulation conduit and allow a
current for the emitting or receiving of electric current from the
posterior face 110 of the retractor blade 12. Other than the
electrode contact(s) 114, the remainder of the conductive trace 110
is insulated with a dielectric coating to prevent current shunting.
Any number of conductive materials suitable for completing the
current pathway, such as, for example, silver, or copper may be
used in the conductive trace 110 without departing from the scope
of this disclosure. According to the implementation show in FIG.
25, there is provided one conductive trace 110 along the
longitudinal axis of the retractor blade 12 that includes 6
discrete traces, each one ending in one of six electrode contacts
114 that serve as stimulation conduits (for recording or
stimulating purposes as set forth above). At the proximal end of
the retractor blade the conductive trace 110 may end with a
multi-contact pad (not shown) that is mateable with a suitable
multi-contact coupler. Any number of suitable couplers would be
readily apparent to a person of skill in the art. For example, the
pad may be situated on a post that is received within a female
socket coupler. It is to be appreciated that while six electrode
contact regions are shown, the blade 12 could include more or less
than six electrodes regions.
[0060] FIGS. 26-27 illustrate another exemplary embodiment in which
the retractor blade 12 is further equipped with a posterior shim
element 120. The posterior shim element 120 may include a molded
plastic part with at least one conductive trace 122 disposed on its
posterior face 124. Preferably, the posterior shim element 120 is
made out of a generally stiff material that can also withstand
bending without breaking, such as, for example, PVC. The conductive
trace 122 provides a conductive pathway for the delivery of current
from a current delivery source (such as a clip cable 72 attached to
the shim itself, the retractor blade, and/or the disposable
electrode) to the posterior face 124 of the posterior shim element
120 as well as for the delivery of electrical activity from nerve
tissue at or near the surgical site to the neuromonitoring device.
The posterior face 124 of the posterior shim element 120 has at
least one electrode contact 126 within each conductive trace 122
and this at least one electrode contact 126 can act as a
stimulation conduit and allow a current for the emitting or
receiving of electric current from the posterior face 124 of the
posterior shim element 120. Other than the electrode contact(s)
126, the remainder of the conductive trace 122 is insulated with a
dielectric coating to prevent current shunting. Each conductive
trace will include a discrete trace for each electrode contact 126
associated with the trace. Any number of conductive materials
suitable for completing the current pathway, such as, for example,
silver, or copper may be used in the conductive trace without
departing from the scope of this disclosure. According to the
implementation show in FIGS. 26-27, the posterior shim element 120
includes two conductive trace elements 122, with one conductive
trace 122 positioned on either side of the longitudinal axis of the
retractor blade 12. To couple the shim to the stimulation source,
each trace may include, for example, a wire extension with
multi-contact pad that may extend out of the operating corridor
when the shim is positioned. Along each conductive trace 122, there
are four electrode contacts 126 that serve as stimulation conduits
(for recording or stimulating purposes as set forth above), and
thus each trace 122 includes four discrete traces. It is to be
appreciated that while four electrode contact regions are shown for
each trace 122, the more or less than for electrode contacts may be
included along each trace 122.
[0061] According to another embodiment shown in FIGS. 28-29, the
posterior shim element may be a locking intradiscal shim 130
removably couplable to the retractor blade 12. The locking
intradiscal shim 130 of the current embodiment is substantially
similar in structure to the locking intradiscal shim 56 described
above with reference to FIGS. 4-6 such that common features need
not be repeated. The locking intradiscal shim 130 may include a
molded plastic part with a conductive trace 132 deposited on its
posterior face 134. Preferably, the posterior shim element 130 is
made out of a generally stiff material that can also withstand
bending without breaking, such as, for example, PVC. The conductive
trace 132 provides a conductive pathway for the delivery of current
from a current delivery source (such as a clip cable 72 attached to
the shim itself, the retractor blade, and/or the disposable
electrode) to the posterior face 134 of the locking intradiscal
shim 130 as well as for the delivery of electrical activity from
nerve tissue at or near the surgical site to the neuromonitoring
device. The posterior face 134 of the locking distal shim 130 has
at least one electrode contact 136 within the conductive trace 134
and this at least one electrode contact 136 can act as a
stimulation current and allow a current for the emitting or
receiving of electric current from the posterior face 134 of the
locking intradiscal shim 130. The conductive trace 134 includes a
discrete trace for each of the at least one electrodes. Other than
the electrode contact(s) 136, the remainder of the conductive trace
132 is insulated with a dielectric coating to prevent current
shunting. Any number of conductive materials suitable for
completing the current pathway, such as, for example, silver, or
copper may be used in the conductive trace 132 without departing
from the scope of this disclosure. According to the implementation
show in FIG. 28, four electrode contacts 136 are shown and are
generally disposed linearly along the length of the locking
intradiscal shim 130. These electrode contacts 136 can serve as a
stimulation conduit (acting as either a stimulation site or a
recording site as set forth above). However, it is to be
appreciated that any number of electrode contacts 136 may be
provided in any number of configurations.
[0062] For the sake of illustration purposes only, the shim 120 of
FIG. 26-27 is coupled to a retractor blade 12 whereas the shim 130
of FIGS. 28-29 coupled to a retractor blade-electrode body
assembly. It is to be appreciated that the shims of the current
disclosure may be used with either configuration.
[0063] As mentioned above, any number of distraction components
and/or retraction components (including but not limited to those
described herein) may be equipped to detect the presence of (and
optionally the distance and/or direction to) neural structures
during tissue distraction and/or retraction. This is accomplished
by employing the following steps: (1) one or more stimulation
electrodes are provided on the various distraction and/or
retraction components; (2) a stimulation source (e.g. voltage or
current) is coupled to the stimulation electrodes; (3) a
stimulation signal is emitted from the stimulation electrodes as
the various components are advanced towards or maintained at or
near the surgical target site; and (4) the patient is monitored to
determine if the stimulation signal causes muscles associated with
nerves or neural structures within the tissue to innervate. If the
nerves innervate, this may indicate that neural structures may be
in close proximity to the distraction and/or retraction
components.
[0064] FIGS. 30-31 illustrate, by way of example only, a monitoring
system 170 suitable for use with the surgical access system 10 of
the present disclosure. The monitoring system 170 includes a
control unit 172, a patient module 174, and an EMG harness 176 and
return electrode 178 coupled to the patient module 174, and a cable
182 for establishing electrical communication between the patient
module 174 and any number of surgical accessories 196, including
the surgical access system of the present disclosure (retractor
assembly 10 of FIG. 1 and distraction assemblies 40, 50 of FIG. 7,
including K-wire 42, initial dilator 44 and sequentially dilating
cannulae 52, 54). The surgical accessories 196 may further include,
but are not necessarily limited to, devices for performing pedicle
screw tests (such as a screw test probe 198), neural pathology
monitoring devices (such as a nerve root retractor 200), coupling
devices for electronically coupling surgical instruments to the
system 170 (such as electric coupling devices 202, 204 and
stimulator driver 206), and pilot hole forming components (such as
a tap member 208, pedicle access probe 210, or other similar
device). More specifically, this electrical communication can be
achieved by providing, by way of example only, a hand-held
stimulation driver 206 capable of selectively providing a
stimulation signal (due to the operation of manually operated
buttons on the hand-held stimulation controller 206) to one or more
connectors (e.g., coupling devices 202, 204). The coupling devices
202, 204 are suitable to establish electrical communication between
the hand-held stimulation controller 206 and (by way of example
only) the stimulation electrodes on the K-wire 42, the dilators 44,
52, 54, the retractor blades 12, 16, 18, and/or the shim element 56
(collectively "surgical access instruments").
[0065] In order to use the monitoring system 170, then, these
surgical access instruments must be connected to at least one of
coupling devices 202, 204 (or similar couplers including
multi-contact regions, not shown), at which point the user may
selectively initiate a stimulation signal (preferably, a current
signal) from the control unit 172 to a particular surgical access
instruments. Stimulating the electrode(s) on these surgical access
instruments before, during, and/or after establishing operative
corridor will cause nerves that come into close or relative
proximity to the surgical access instruments to depolarize,
producing a response in a myotome associated with the innervated
nerve.
[0066] The control unit 172 includes a touch screen display 190 and
a base 192, which collectively contain the essential processing
capabilities (software and/or hardware) for controlling the
monitoring system 170. The control unit 172 may include an audio
unit 168 that emits sounds according to a location of a surgical
element with respect to a nerve. The patient module 174 is
connected to the control unit 172 via a data cable 194, which
establishes the electrical connections and communications (digital
and/or analog) between the control unit 172 and patient module 174.
The main functions of the control unit 172 include receiving user
commands via the touch screen display 190, activating stimulation
electrodes on the surgical access instruments, processing signal
data according to defined algorithms, displaying received
parameters and processed data, and monitoring system status and
report fault conditions. The touch screen display 190 is preferably
equipped with a graphical user interface (GUI) capable of
communicating information to the user and receiving instructions
from the user. The display 190 and/or base 192 may contain patient
module interface circuitry (hardware and/or software) that commands
the stimulation sources, receives digitized signals and other
information from the patient module 174, processes the EMG
responses to extract characteristic information for each muscle
group, and displays the processed data to the operator via the
display 190.
[0067] In one embodiment, the monitoring system 170 is capable of
determining nerve direction relative to one or more of the K-wire
42, the dilators 44, 52, 54, the retractor blades 12, 16, 18,
and/or the shim element 56 before, during and/or following the
creation of an operative corridor to a surgical target site.
Monitoring system 170 accomplishes this by having the control unit
172 and patient module 174 cooperate to send electrical stimulation
signals to one or more of the stimulation electrodes provided on
these instruments. Depending upon the location of the surgical
access system 10 within a patient (and more particularly, to any
neural structures), the stimulation signals may cause nerves
adjacent to or in the general proximity of the surgical access
system 10 to depolarize. This causes muscle groups to innervate and
generate EMG responses, which can be sensed via the EMG harness
176. The nerve direction feature of the system 170 is based on
assessing the evoked response of the various muscle myotomes
monitored by the system 170 via the EMG harness 176.
[0068] By monitoring the myotomes associated with the nerves (via
the EMG harness 176 and recording electrode 177) and assessing the
resulting EMG responses (via the control unit 172), the surgical
access system 10 is capable of detecting the presence of (and
optionally the distant and/or direction to) such nerves. This
provides the ability to actively negotiate around or past such
nerves to safely and reproducibly form the operative corridor to a
particular surgical target site, as well as monitor to ensure that
no neural structures migrate into contact with the surgical access
system 10 after the operative corridor has been established. In
spinal surgery, for example, this is particularly advantageous in
that the surgical access system 10 may be particularly suited for
establishing an operative corridor to an intervertebral target site
in a postero-lateral, trans-psoas fashion so as to avoid the bony
posterior elements of the spinal column.
[0069] FIGS. 32-33 are exemplary screen displays (to be shown on
the display 190) illustrating one embodiment of the nerve direction
feature of the monitoring system shown and described with reference
to FIG. 30-31. These screen displays are intended to communicate a
variety of information to the surgeon in an easy-to-interpret
fashion. This information may include, but is not necessarily
limited to, a display of the function 230 (in this case
"DIRECTION"), a graphical representation of a patient 231, the
myotome levels being monitored 232, the nerve or group associated
with a displayed myotome 233, the name of the instrument being used
234 (in this case, a dilator 52, 54), the size of the instrument
being used 235, the stimulation threshold current 236, a graphical
representation of the instrument being used 237 (in this case, a
cross-sectional view of a dilator 52, 54) to provide a reference
point from which to illustrate relative direction of the instrument
to the nerve, the stimulation current being applied to the
stimulation electrodes 238, instructions for the user 239 (in this
case, "ADVANCE" and/or "HOLD"), and an arrow 240 indicating the
direction from the instrument to a nerve. This information may be
communicated in any number of suitable fashions, including but not
limited to the use of visual indicia (such as alpha-numeric
characters, light-emitting elements, and/or graphics) and audio
communications (such as a speaker element). Although shown with
specific reference to a dilating cannula (such as at 234), it is to
be readily appreciated that the present disclosure is deemed to
include providing similar information on the display 190 during the
use of any or all of the various instruments forming the surgical
access system 10 of the present disclosure, including the
distraction assembly 40 (i.e. the K-wire 42 and dilators 44, 52,
54) and/or the retractor blades 12, 16, 18 and/or the shim element
56.
[0070] According to another broad aspect of the present disclosure,
the method for monitoring the status of a nerve relative to a
retractor blade 12 include the steps of: (a) localizing the depth
of a nerve relative to one or more components of a tissue
retraction system 10 and (b) performing one or both of stimulating
and recording evoked neurophysiologic responses from that
location.
[0071] The step of localizing the depth of a nerve is preferably
carried out prior to retraction of tissue within the lateral access
corridor. In embodiments with multiple electrodes on the electrode
body, retractor blade, posterior shim element, or locking
intradiscal shim, nerve depth can be localized by first determining
the stimulation threshold intensity required to elicit a
significant neuromuscular response at each electrode point.
Stimulation current may be directed to one electrode and increased
until a significant neuromuscular response is elicited. This step
is then repeated for each electrode point. Determinations of
stimulation thresholds may be made using a linear or non-linear
hunting algorithm such as, for example, the threshold hunting
algorithm or algorithms described in the above-referenced '045
patent (incorporated by reference). The electrode point that
elicits the neuromuscular response with the lowest stimulation
threshold intensity is the one that the closest nerve is nearest to
(which indicates the depth and proximity of the nerve relative to
the retractor blade). Software resident on the neuromonitoring
system records the electrode which is determined to be closest to
the nerve for subsequent monitoring of that nerve.
[0072] In embodiments with one distal electrode that is movable
along at least a portion of the length of the retractor blade,
nerve depth can be localized by first determining the stimulation
threshold intensity required to elicit a significant neuromuscular
response from the electrode at one or more locations along the
length of the blade. Stimulation current may be emitted through the
electrode and increased until a significant neuromuscular response
is elicited. This step is then repeated at one or more additional
locations. Determinations of stimulation thresholds may be made
using a linear or non-linear hunting algorithm (as described in the
above-referenced '045 patent). Dynamically monitoring these
thresholds allows these steps to be performed seamlessly with
continual threshold updating as the electrode is moved up or down
along the retractor blade, making it simple for the user to hone in
on the appropriate location while watching the threshold changes on
the neuromonitoring display. The electrode position location that
elicits the neuromuscular response with the lowest stimulation
threshold intensity is the location that the closest nerve is
nearest to (indicating the depth and proximity of the nerve
relative to the retractor blade). Once the electrode is located in
the selected position, the electrode may be fixed in position for
subsequent monitoring of the nerve.
[0073] In some implementations, determinations of the stimulation
threshold intensities may be achieved by bipolar stimulation. By
way of example only, in embodiments with multiple electrode
locations, one exposed contact would act as the first pole and an
adjacent exposed contact would act the second pole. Also by way of
example only, in embodiments with one distal stimulation electrode,
a secondary electrode may be provided (for example, spaced 1 cm
apart from the stimulation electrode (not shown)) to act as the
cathode. Bipolar stimulation results in more localized current flow
which may decrease the amount of depolarization of nearby
musculature (for example, the psoas muscle). Thus, bipolar
stimulation may be advantageous to further minimize the amount of
patient movement during stimulation.
[0074] Once information relating to the depth of the nearby nerve
is ascertained, additional neurophysiologic testing may be
performed to monitor the health and status of that nerve throughout
the portions of the surgical procedure in which the retractor is
used to maintain the lateral access corridor. Utilizing the minimum
threshold technique over multiple locations not only localizes the
depth of the nerve, but also indicates proximity (i.e. the position
along the retractor that the nerve is closest to). Therefore, the
location that requires the lowest threshold intensity to elicit a
significant neuromuscular response may also be the ideal
stimulation site and recording site for neurophysiologic testing of
the nerve closest to the retractor blade. By way of example only,
the location (either the specific electrode or electrode position)
on the retractor blade or shim requiring the lowest threshold
stimulation intensity to elicit a significant neuromuscular site
may serve as an ideal stimulation site from subsequent evoked EMG
testing of that nerve during the surgical procedure. Evoked EMG
testing may be performed at multiple time points throughout the
surgical procedure and any changes to the threshold intensity
required to elicit a significant neuromuscular response may be
indicative as to changes to the health and/or status of the nerve
over time (for example, compression of the nerve). Also, this
location (either specific electrode or electrode position) on the
retractor blade or shim may also serve as an ideal recording site
for subsequent evoked compound muscle action potential (CMAP)
and/or sensory nerve action potential (CNAP) testing of that nerve
during the surgical procedure. CMAPs and CNAPs may be evoked at
multiple time points throughout the surgical procedure and any
changes to the threshold intensity required to elicit a significant
response, any changes in amplitude of the response, and/or any
changes in latency of the response may be indicative as to changes
of the health and/or status of the nerve over time (for example,
compression of the nerve). The neuromonitoring system may quickly
and accurately determine this data and convey the useful
information in a simple and easily comprehensible manner for
interpretation by a surgeon, neurophysiologist, or other medical
personnel. It is contemplated that the control unit of the
neuromonitoring system may automatically ascertain this information
and/or communicate any of numerical, graphic, audio, and visual
feedback corresponding to one or more of these findings. Armed with
this useful information, the surgeon may detect a problem or
potential problem early and then act to avoid and/or mitigate the
problem.
[0075] As evident from the above discussion and drawings, the
present disclosure accomplishes the goal of gaining access a
surgical target site in a fashion less invasive than traditional
"open" surgeries and, moreover, does so in a manner that provides
the ability to access such a surgical target site regardless of the
neural structures required to be passed through (or near) in order
to establish an operative corridor to the surgical target site. The
present disclosure furthermore provides the ability to perform
neural monitoring in the tissue or regions adjacent the surgical
target site during any procedures performed after the operative
corridor has been established.
[0076] While the disclosure is susceptible to various modifications
and alternative forms, specific embodiments thereof have been shown
by way of example in the drawings and are herein described in
detail. It should be understood, however, that the description
herein of specific embodiments is not intended to limit the
disclosure to the particular forms disclosed, but on the contrary,
the disclosure is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the disclosure
as defined herein. For example, any of the features of a particular
example described herein may be used with any other example
described herein without departing from the scope of the present
disclosure.
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