U.S. patent application number 15/690180 was filed with the patent office on 2019-02-14 for electromyography system.
This patent application is currently assigned to NuVasive, Inc.. The applicant listed for this patent is NuVasive, Inc.. Invention is credited to Brian S. Kelleher, James F. Marino, Jeffrey H. Owen, Corbett W. Stone, Robin H. Vaughn.
Application Number | 20190046058 15/690180 |
Document ID | / |
Family ID | 22607298 |
Filed Date | 2019-02-14 |
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United States Patent
Application |
20190046058 |
Kind Code |
A1 |
Kelleher; Brian S. ; et
al. |
February 14, 2019 |
Electromyography System
Abstract
Systems and methods for performing a surgical procedures on the
spine are described, including a spinal access system. The spinal
access system may have a stimulation cannula with a stimulation
electrode at a distal end. The stimulation cannula is configured to
be advanced along an access path toward a patient's lumbar spine
while coupled to a nerve monitoring system configured to detect
nerves in the path of the stimulation cannula by stimulating the
stimulation electrode at the distal end of the stimulation cannula
and monitoring an electrical current level determined after a
neuro-muscular onset response is detected via one or more return
electrodes positioned on the patient's leg.
Inventors: |
Kelleher; Brian S.; (Ramona,
CA) ; Marino; James F.; (La Jolla, CA) ;
Stone; Corbett W.; (San Diego, CA) ; Vaughn; Robin
H.; (US) ; Owen; Jeffrey H.; (Monkton,
MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NuVasive, Inc. |
San Diego |
CA |
US |
|
|
Assignee: |
NuVasive, Inc.
San Diego
CA
|
Family ID: |
22607298 |
Appl. No.: |
15/690180 |
Filed: |
August 29, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14622585 |
Feb 13, 2015 |
9743853 |
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15690180 |
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13726110 |
Dec 22, 2012 |
8958869 |
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14622585 |
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13196784 |
Aug 2, 2011 |
8337410 |
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13726110 |
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11982238 |
Oct 31, 2007 |
7991463 |
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13196784 |
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10830189 |
Apr 21, 2004 |
7963927 |
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11982238 |
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09722070 |
Nov 24, 2000 |
7470236 |
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10830189 |
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60167416 |
Nov 24, 1999 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/4893 20130101;
A61B 5/04001 20130101; A61B 5/0492 20130101; A61B 17/00234
20130101; A61B 2017/00022 20130101; A61B 2017/00039 20130101; A61B
5/0488 20130101 |
International
Class: |
A61B 5/04 20060101
A61B005/04; A61B 17/00 20060101 A61B017/00; A61B 5/00 20060101
A61B005/00; A61B 5/0488 20060101 A61B005/0488 |
Claims
1. A spinal access system for performing a spinal surgical
procedure, the spinal access system comprising: a stimulation
cannula including a stimulation electrode at a distal end of the
stimulation cannula configured to be advanced along an access path
toward an operative site in the region of a patient's lumbar spine;
and a nerve monitoring system configured for performing nerve
detection of a spinal nerve when the stimulation cannula is
positioned in the access path toward the operative site in the
region of the lumbar spine by stimulating the stimulation electrode
at the distal end of the stimulation cannula and monitoring an
electrical current level determined after a neuro-muscular onset
response is detected via one or more return electrodes positioned
on the patient's leg.
2. The spinal access system of claim 1, wherein the nerve
monitoring system repeatedly performs nerve detection while current
intensity level of a stimulation pulse emitted by the stimulation
electrode is varied over time.
3. The spinal access system of claim 1, wherein the nerve
monitoring system repeatedly performs nerve detection while current
intensity level of a stimulation pulse emitted by the stimulation
electrode is varied incrementally.
4. The spinal access system of claim 1, wherein the nerve
monitoring system visually displays an intensity level of a
neuro-muscular response onset value for the spinal nerve.
5. The spinal access system of claim 1, wherein the nerve
monitoring system is configured to be operated by a surgeon to
provide nerve detection warnings to alert the surgeon operating the
nerve detection system that the spinal nerve is in close proximity
to the stimulation electrode.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 14/622,585, filed Feb. 12, 2015, now issued as
U.S. Pat. No. 9,743,853 (the contents being incorporated herein by
reference), which is a continuation of U.S. application Ser. No.
13/726,110, filed Dec. 12, 2012, now issued as U.S. Pat. No.
8,958,869 (the contents being incorporated herein by reference),
which is a continuation of U.S. application Ser. No. 13/196,784,
filed Aug. 2, 2011, now issued as U.S. Pat. No. 8,337,410 (the
contents being incorporated herein by reference), which is a
continuation of U.S. application Ser. No. 11/982,238, filed Oct.
31, 2007, now issued as U.S. Pat. No. 7,991,463 (the contents being
incorporated herein by reference), which is a continuation of U.S.
application Ser. No. 10/830,189, filed Apr. 21, 2004, now issued as
U.S. Pat. No. 7,963,927 (the contents being incorporated herein by
reference), which is a divisional of U.S. application Ser. No.
09/722,070, filed Nov. 24, 2000, now issued as U.S. Pat. No.
7,470,236 (the contents being incorporated herein by reference),
which claims priority from U.S. Provisional Application Ser. No.
60/167,416 filed Nov. 24, 1999 (the contents being incorporated
herein by reference).
TECHNICAL FIELD
[0002] The present invention relates to electromyography (EMG) and
to systems for detecting the presence of nerves during surgical
procedures.
BACKGROUND OF THE INVENTION
[0003] It is important to avoid unintentionally contacting a
patient's nerves when performing surgical procedures, especially
when using surgical tools and procedures that involve cutting or
boring through tissue. Moreover, it is especially important to
sense the presence of spinal nerves when performing spinal surgery,
since these nerves are responsible for the control of major body
functions. However, avoiding inadvertent contact with these nerves
is especially difficult due to the high nerve density in the region
of the spine and cauda equina.
[0004] The advent of minimally invasive surgery offers great
benefits to patients through reduced tissue disruption and trauma
during surgical procedures. Unfortunately, a downside of such
minimally invasive surgical procedures is that they tend to offer a
somewhat reduced visibility of the patient's tissues during the
surgery. Accordingly, the danger of inadvertently contacting and/or
severing a patient's nerves can be increased.
[0005] Systems exist that provide remote optical viewing of a
surgical site during minimally invasive surgical procedures.
However, such systems cannot be used when initially penetrating
into the tissue. Moreover, such optical viewing systems cannot
reliably be used to detect the location of small diameter
peripheral nerves.
[0006] Consequently, a need exists for a system that alerts an
operator that a particular surgical tool, which is being minimally
invasively inserted into a patient's body, is in close proximity to
a nerve. As such, the operator may then redirect the path of the
tool to avoid inadvertent contact with the nerve. It is especially
important that such a system alerts an operator that a nerve is
being approached as the surgical tool is advanced into the
patient's body prior to contact with the nerve, such that a safety
distance margin between the surgical tool and the nerve can be
maintained.
[0007] A variety of antiquated, existing electrical systems are
adapted to sense whether a surgical tool is positioned adjacent to
a patient's nerve. Such systems have proven to be particularly
advantageous in positioning a hypodermic needle adjacent to a nerve
such that the needle can be used to deliver anesthetic to the
region of the body adjacent the nerve. Such systems rely on
electrifying the needle itself such that as a nerve is approached,
the electrical potential of the needle will depolarize the nerve
causing the muscle fibers coupled to the nerve to contract and
relax, resulting in a visible muscular reaction, seen as a
"twitch".
[0008] A disadvantage of such systems is that they rely on a visual
indication, being seen as a "twitch" in the patient's body. During
precision minimally invasive surgery, uncontrollable patient
movement caused by patient twitching, is not at all desirable,
since such movement may itself be injurious. In addition, such
systems rely on the operator to visually detect the twitch.
Accordingly, such systems are quite limited, and are not
particularly well adapted for use in minimally invasive
surgery.
SUMMARY OF THE INVENTION
[0009] The present invention provides methods and apparatus for
informing an operator that a surgical tool or probe is approaching
a nerve. In preferred aspects, the surgical tool or probe may be
introduced into the patient in a minimally invasive cannulated
approach. In alternate aspects, the surgical tool or probe
comprises the minimally invasive cannula itself.
[0010] In a first aspect, the present invention provides a system
for detecting the presence of a nerve near a surgical tool or
probe, based upon the current intensity level of a stimulus pulse
applied to the surgical tool or probe. When a measurable
neuro-muscular (EMG) response is detected from a stimulus pulse
having a current intensity level at or below a pre-determined onset
level, the nerve is considered to be near the tool or probe and
thus, detected.
[0011] In an optional second aspect of the invention, the onset
level (i.e.: the stimulus current level at which a neuro-muscular
response is detected for a particular nerve) may be based on EMG
responses measured for a probe at a predetermined location relative
to the nerve. Specifically, onset levels may first be measured for
each of a plurality of spinal nerves, (yielding an initial
"baseline" set of neuro-muscular response onset threshold levels),
which are then used in the first (nerve detection) aspect of the
invention. Therefore, in accordance with this optional second
aspect of the invention, a system for determining relative
neuro-muscular onset values (i.e.: EMG response thresholds), for a
plurality of spinal nerves is also provided. Accordingly, the
pre-determined onset level may be compared to the current level
required to generate a measurable EMG response for a tool or probe
being advanced toward one or more nerves of interest.
[0012] In alternate aspects, however, the neuro-muscular onset
values that are used to accomplish the first (nerve detection)
aspect of the invention are not measured for each of the patient's
plurality of spinal nerves. Rather, pre-determined levels of
current intensity (below which neuro-muscular responses are
detected in accordance with the first aspect of the invention) can
instead be directly pre-set into the system. Such levels preferably
correspond to specific expected or desired onset threshold values,
which may have been determined beforehand by experimentation on
other patients.
[0013] In the aspect of the invention where initial "baseline"
neuro-muscular onset values are determined prior to nerve
detection, such onset values can optionally be used to calibrate
the present nerve-detection system (which in turn operates to
detect whether an minimally invasive surgical tool or probe is
positioned adjacent to a spinal nerve).
[0014] It is to be understood, therefore, that the present
invention is not limited to systems that first determine relative
neuro-muscular onset values, and then use these neuro-muscular
onset values to detect the presence of a nerve. Rather, the present
invention includes an optional system to first determine relative
neuro-muscular onset values and a system to detect the presence of
a nerve (using the neuro-muscular onset values which have been
previously determined). As such, the present invention encompasses
systems that also use fixed neuro-muscular onset values (which may
simply be input into the system hardware/software by the operator
prior to use) when performing electromyographic monitoring of
spinal nerves to detect the presence of a spinal nerve adjacent a
tool or probe.
[0015] In optional aspects, the preferred method of sensing for the
presence of a nerve may be continuously repeated as the
probe/surgical tool is physically advanced further into the patient
such that the operator is warned quickly when the probe/surgical
tool is closely approaching the nerve.
[0016] In the first (nerve sensing) aspect of the invention, the
present nerve-detection system comprises an electrode or electrodes
positioned on the distal end of the surgical tool or probe, with an
electromyographic system used to detect whether a spinal nerve is
positioned adjacent to the surgical tool or probe. A conclusion is
made that the surgical tool or probe is positioned adjacent to a
spinal nerve when a neuro-muscular (e.g.: EMG) response to a
stimulus pulse emitted by the electrode or electrodes on the
surgical tool or probe is detected (at a distant myotome location,
such as on the patient's legs) at or below certain neuro-muscular
response onset values (i.e.: pre-determined current intensity
levels) for each of the plurality of spinal nerves. The stimulus
pulse itself may be emitted from a single probe, but in an optional
aspect, the stimulus pulse may be emitted from separate left and
right probes with the signals being multiplexed. As stated above,
such pre-determined levels may be pre-input by the operator (or be
pre-set into the system's hardware or software) and may thus
optionally correspond to known or expected values. (For example,
values as measured by experimentation on other patients).
[0017] In accordance with the optional second (neuro-muscular
response onset value determination) aspect of the invention, the
neuro-muscular response onset values used in nerve detection may
instead be measured for the particular patient's various nerves, as
follows.
[0018] Prior to attempting to detect the presence of a nerve, an
EMG stimulus pulse is first used to depolarize a portion of the
patient's cauda equina. This stimulus pulse may be carried out with
a pulse passing between an epidural stimulating electrode and a
corresponding skin surface return electrode, or alternatively,
between a pair of electrodes disposed adjacent to the patient's
spine, or alternatively, or alternatively, by a non-invasive
magnetic stimulation means. It is to be understood that any
suitable means for stimulating (and depolarizing a portion of) the
patient's cauda equina can be used in this regard.
[0019] After the stimulus pulse depolarizes a portion of the
patient's cauda equina, neuro-muscular (i.e., EMG) responses to the
stimulus pulse are then detected at various myotome locations
corresponding to a plurality of spinal nerves, with the current
intensity level of the stimulus pulse at which each neuro-muscular
response is first detected being the neuro-muscular response "onset
values" for each of the plurality of spinal nerves.
[0020] It is to be understood that the term "onset" as used herein
is not limited to a condition in which all of the muscle fibers in
a bundle of muscle fibers associated with a particular nerve
exhibit a neuro-muscular response. Rather, an "onset" condition may
comprise any pre-defined majority of the muscle fibers associated
with a particular nerve exhibit a neuro-muscular response.
[0021] In an additional aspect of the invention, the relative
neuro-muscular response onset values can be repeatedly
re-determined (at automatic intervals or at intervals determined by
the operator) so as to account for any changes to the response
onset values caused by the surgical procedure itself. Accordingly,
a further advantage of the present invention is that it permits
automatic re-assessment of the nerve status, with the relative
neuro-muscular response onset values for each of the plurality of
spinal nerves being re-determined before, during and after the
surgical procedure, or repeatedly determined again and again during
the surgical procedure. This optional aspect is advantageous during
spinal surgery as the surgery itself may change the relative
neuro-muscular response onset values for each of the plurality of
nerves, such as would be caused by reducing the pressure on an
exiting spinal nerve positioned between two adjacent vertebrae.
This periodic re-determination of the onset values can be carried
out concurrently with the nerve sensing function.
[0022] Accordingly, an advantageous feature of the present
invention is that it can simultaneously indicate to an operator
both: (1) nerve detection (i.e.: whether the surgical tool/probe is
near a nerve); and (2) nerve status changes (i.e.: the change in
each nerve's neuro-muscular response onset values over time). The
surgeon is thus able to better interpret the accuracy of nerve
detection warnings by simultaneously viewing changes in the various
onset levels. For example, should the surgeon note that a
particular onset value (i.e.: the current level of a stimulus pulse
required to elicit an EMG response for a particular nerve) is
increasing, this would tend to show that this nerve pathway is
becoming less sensitive. Accordingly, a "low" warning may be
interpreted to more accurately correspond to a "medium" likelihood
of nerve contact; or a "medium" warning may be interpreted to more
accurately correspond to a "high" likelihood of nerve contact.
[0023] Optionally, such re-assessment of the nerve status can be
used to automatically re-calibrate the present nerve detection
system. This can be accomplished by continually updating the onset
values that are then used in the nerve detection function.
[0024] In preferred aspects, the neuro-muscular response onset
values for each of the plurality of spinal nerves are measured at
each of the spaced-apart myotome locations, and are visually
indicated to an operator (for example, by way of an LED scale).
Most preferably, the measuring of each of the various
neuro-muscular response onset values is repeatedly carried out with
the present and previously measured onset value levels being
simultaneously visually indicated to an operator such as by way of
the LED scale.
[0025] Accordingly, in one preferred aspect, for example, different
LED lights can be used to indicate whether the value of each of the
various neuro-muscular response onset values is remaining constant
over time, increasing or decreasing. An advantage of this optional
feature of the invention is that a surgeon operating the device can
be quickly alerted to the fact that a neuro-muscular response onset
value of one or more of the spinal nerves has changed. Should the
onset value decrease for a particular nerve, this may indicate that
the nerve was previously compressed or impaired, but become
uncompressed or no longer impaired.
[0026] In a particular preferred embodiment, example, a blue LED
can be emitted at a baseline value (i.e.: when the neuro-muscular
response onset value remains the same as previously measured); and
a yellow light can be emitted when the neuro-muscular response
onset value has increased from that previously measured; and a
green light being emitted when the neuro-muscular response onset
value has decreased from that previously measured.
[0027] In an alternate design, different colors of lights may be
simultaneously displayed to indicate currently measured onset
values for each of the plurality of spinal nerve myotome locations,
as compared to previously measured onset values. For example, the
present measured onset value levels for each of the plurality of
spinal nerve myotome locations can appear as yellow LED lights on
the LED scale, with the immediately previously measured onset value
levels simultaneously appearing as green LED lights on the LED
scale. This also allows the operator to compare presently measured
(i.e. just updated) neuro-muscular response onset values to the
previously measured neuro-muscular response onset values.
[0028] In preferred aspects, the present system also audibly alerts
the operator to the presence of a nerve. In addition, the volume or
frequency of the alarm may change as the probe/tool moves closer to
the nerve.
[0029] In a preferred aspect of the present invention, the
neuro-muscular onset values, (which may be detected both when
initially determining the relative neuro-muscular response onset
values in accordance with the second aspect of the invention, and
also when detecting a neuro-muscular onset response to the emitted
stimulus pulse from the probe/tool in accordance with the first
aspect of the invention), are detected by monitoring a plurality of
distally spaced-apart myotome locations which anatomically
correspond to each of the spinal nerves. Most preferably, these
myotome locations are selected to correspond to the associated
spinal nerves that are near the surgical site. Therefore, these
myotome locations preferably correspond with distally spaced-apart
on the patient's legs (when the operating site is in the lower
vertebral range), but may also include myotome locations on the
patient's arms (when the operating site is in the upper vertebral
range). It is to be understood, however, that the present system
therefore encompasses monitoring of any relevant myotome locations
that are innervated by nerves in the area of surgery. Therefore,
the present invention can be adapted for use in cervical, thoracic
or lumbar spine applications.
[0030] During both the optional initial determination of the
relative neuro-muscular response onset values for each of the
plurality of spinal nerves (i.e.: the second aspect of the
invention) and also during the detection of neuro-muscular onset
responses to the stimulus pulse from the surgical probe/tool (i.e.:
the first aspect of the invention), the emission of the stimulus
pulse is preferably of a varying current intensity. Most
preferably, the stimulus pulse is incrementally increased
step-by-step in a "staircase" fashion over time, at least until a
neuro-muscular response signal is detected. The stimulus pulse
itself may be delivered either between a midline epidural electrode
and a return electrode, or between two electrodes disposed adjacent
the patient's spine, or from an electrode disposed directly on the
probe/tool, or by other means.
[0031] An important advantage of the present system of increasing
the level of stimulus pulse to a level at which a response is first
detected is that it avoids overstimulating a nerve (which may cause
a patient to "twitch"), or cause other potential nerve damage.
[0032] In optional preferred aspects, the "steps" of the staircase
of increasing current intensity of the stimulus pulse are carried
out in rapid succession, most preferably within the refractory
period of the spinal nerves. An advantage of rapidly delivering the
stimulus pulses within the refractory period of the spinal nerves
is that, at most, only a single "twitch" will be exhibited by the
patient, as opposed to a muscular "twitching" response to each
level of the stimulation pulse as would be the case if the
increasing levels of stimulus pulse were instead delivered at
intervals of time greater than the refractory period of the
nerves.
[0033] In another optional preferred aspect, a second probe is
added to the present system, functioning as a "confirmation
electrode". In this optional aspect, an electrode or electroded
surface on the second probe is also used to detect the presence of
a nerve, (using the same system as was used for the first probe to
detect a nerve). Such a second "confirmation electrode" probe is
especially useful when the first probe is an electrified cannula
itself, and the second "confirmation electrode" probe is a separate
probe that can be advanced through the electrified cannula. For
example, as the operating (electrified) cannula is advanced into
the patient, this operating cannula itself functions as a nerve
detection probe. As such, the operating cannula can be advanced to
the operating site without causing any nerve damage. After this
cannula has been positioned at the surgical site, it may then be
used as the operating cannula through which various surgical tools
are then advanced. At this stage, its nerve-sensing feature may be
optionally disabled, should this feature interfere with other
surgical tools or procedures. Thereafter, (and at periodic
intervals, if desired) the second "confirmation electrode" probe
can be re-advanced through the operating cannula to confirm that a
nerve has not slipped into the operating space during the surgical
procedure. In the intervals of time during which this second
"confirmation electrode" probe is removed from the operating
cannula, access is permitted for other surgical tools and
procedures. The second "confirmation electrode" probe of the
present invention preferably comprises a probe having an electrode
on its distal end. This confirmation electrode may either be
mono-polar or bi-polar.
[0034] In an optional preferred aspect, the second "confirmation
electrode" probe may also be used as a "screw test" probe.
Specifically, the electrode on the secondary "confirmation" probe
may be placed in contact with a pedicle screw, thereby electrifying
the pedicle screw. Should the present invention detect a nerve
adjacent such an electrified pedicle screw, this would indicate
that pedicle wall is cracked (since the electrical stimulus pulse
has passed out through the crack in the pedicle wall and stimulated
a nerve adjacent the pedicle).
[0035] An advantage of the present system is that it may provide
both nerve "detection" (i.e.: sensing for the presence of nerves as
the probe/tool is being advanced) and nerve "surveillance" (i.e.:
sensing for the presence of nerves when the probe/tool had been
positioned).
[0036] A further important advantage of the present invention is
that it simultaneously monitors neuro-muscular responses in a
plurality of different nerves. This is especially advantageous when
operating in the region of the spinal cord due to the high
concentration of different nerves in this region of the body.
Moreover, by simultaneously monitoring a plurality of different
nerves, the present system can be used to indicate when relative
nerve response onset values have changed among the various nerves.
This information can be especially important when the surgical
procedure being performed can alter the relative nerve response
onset value of one or more nerves with respect to one another.
[0037] A further advantage of the present system is that a weaker
current intensity can be applied at the nerve detecting electrodes
(on the probe) than at the stimulus (i.e.: nerve status)
electrodes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] FIG. 1 is an illustration of various components of the
present invention in operation.
[0039] FIG. 2 shows a current intensity staircase for an
electromyographic stimulation (nerve status) electrode.
[0040] FIG. 3 shows a current intensity staircase for an
electromyographic stimulation pulse for a nerve detection electrode
disposed on a probe.
[0041] FIG. 4 corresponds to FIG. 1, but also shows exemplary
"high", "medium" and "low" warning levels corresponding to
exemplary neuro-muscular response onset levels.
[0042] FIG. 5 shows a patient's spinal nerves, and corresponding
myotome monitoring locations.
[0043] FIG. 6 is an illustration of the waveform characteristics of
a stimulus pulse and a corresponding neuro-muscular (EMG) response
as detected at a myotome location.
[0044] FIG. 7 is a schematic diagram of a nerve detection
system.
[0045] FIG. 8A is an illustration of the front panel of one design
of the present nerve status and detection system.
[0046] FIG. 8B is an illustration of the front panel of another
design of the present nerve status and detection system.
[0047] FIG. 9A is an illustration of a cannula and a probe for use
with the nerve status and detection system.
[0048] FIG. 9B is an illustration the probe of FIG. 9A situated in
the cannula of FIG. 9A.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0049] The present invention sets forth systems for detecting when
a nerve is near or adjacent to an electrified surgical tool, probe,
cannula, or other surgical instrument. The present invention also
involves optional systems for simultaneously determining the
"status" (e.g.: sensitivity) of a plurality of nerves.
[0050] As will be explained, the present system involves applying a
signal with a current level to a probe near a nerve and determining
whether an electromyographic "EMG" (i.e.: neuro-muscular) response
for a muscle coupled to the nerve is present.
[0051] In preferred aspects, the present system applies a signal
with a known current level (mA) to a "probe" (which could be
midline probe, a cannula, a needle, etc.) Depending on the current
level, distance to the nerve, and health of the nerve, an EMG may
be detected in a muscle coupled to the nerve. In accordance with
preferred aspects, an EMG response is determined to have been
detected when the peak-to-peak response of the EMG signal is
greater than some level (mVolts). In other words, an EMG response
is determined to have been detected when the stimulus current level
generates an EMG having a peak-to-peak value greater than a
pre-determined level (for example, 60 mV or 80 mV in spinal nerve
applications.) Such stimulus current level at which an EMG response
is detected is termed the "onset" current level for the nerve.
[0052] In optional aspects, the present invention also sets forth
systems for determining these onset current values (i.e.:
determining the stimulus current level at which an EMG response is
detected with a maximum peak-to-peak value greater than a
predetermined level). Such onset values may be determined for a
plurality of nerves either in absolute terms, or in relation to one
another.
[0053] The first aspect of the present invention involves nerve
detection. In the optional second aspect of the invention, nerve
status information may be used to aid nerve detection. The nerve
status aspect determines the minimum current level of a signal
applied to a probe near a nerve needed to generate onset EMG
response for a muscle coupled to a nerve of interest. The present
invention may use this determined minimum current level when
determining whether a probe is near the same nerve.
[0054] In optional aspects, the present invention may involve
determining an initial set of "baseline" neuro-muscular response
onset values for a plurality of different spinal nerve pathways.
This optional second (nerve status) aspect of the present invention
is preferably carried out prior to the first (nerve detection)
aspect of the invention, with the initial set of "baseline"
neuro-muscular onset values then optionally being used in the nerve
detection function, as will be explained below. As the optional
second aspect of the invention is carried out prior to carrying out
the first aspect of the invention, it will be described first.
[0055] In the nerve status determination, the minimum current level
of a signal applied to a probe needed to generate an onset
neuro-muscular response (i.e.: EMG response) is first determined
for each of a plurality of nerves, as follows. Referring to FIG. 1,
a patient's vertebrae L1, L2, L3, L4, L5, and S1 are shown. In a
preferred aspect of the present invention, a portion of the
patient's cauda equina is stimulated (i.e. depolarized). This
depolarization of a portion of the patient's cauda equina may be
achieved by conducting a stimulus pulse having a known current
level between an epidural stimulating electrode 11 and a patient
return electrode 13. Electrodes 11 and 13 are referred to herein as
"status" electrodes, as they assist in determining the initial
status of the various nerve pathways). The epidural electrode is
placed in the epidural space of the spine. Alternatively, the
depolarization of a portion of the patient's cauda equina may be
achieved by conducting a stimulus pulse having a known current
level between a pair of status (baseline) electrodes 12 and 14,
which may be positioned adjacent the (thoracic/lumbar) T/L junction
(above vertebra L1), as shown. Status electrodes 12 and 14 may be
positioned in-line at the T/L junction, (as shown in FIG. 1).
Status electrodes 12 and 14 could also be positioned on opposite
lateral sides of the T/L junction.
[0056] In a preferred aspect, neuro-muscular (i.e., EMG), responses
to the stimulus pulse by muscles coupled to nerves near the
stimulating electrode are detected by electrodes positioned at each
of a plurality of myotome locations MR1, MR2, and MR3 on the
patient's right leg, and myotome locations ML1, ML2, and ML3 on the
patient's left leg. The sensing of neuro-muscular responses at
these locations may be performed with needle electrodes, or
electrodes placed on the surface of the patient's skin, as desired.
An EMG response at each location MR1 to MR6 is detected when the
maximum peak-to-peak height of the EMG response to the stimulus
pulse is greater than a predetermined mV value (called "onset").
Accordingly, the current level required to elicit an onset EMG
response is called the "onset" current level. As described below,
the current level of the stimulus pulse or signal applied to the
electrode 11 or electrodes 12, 14 may be incremented from a low
level until an onset EMG response is detected for one or more of
the myotome locations MR1 to ML3.
[0057] It is to be understood that myotome sensing may be carried
out at more than the three distal locations illustrated on each of
the patient's legs in FIG. 1. Generally, as greater numbers of
distal myotome locations are monitored, a greater number of spinal
nerves corresponding to each of these myotome locations can be
individually monitored, thereby enhancing the present system's
nerve detection ability over a larger section of the patient's
spinal column.
[0058] It is also to be understood that the present invention can
be easily adapted to cervical or thoracic spinal applications (in
addition to the illustrated lumbar application of FIG. 1). In this
case an appropriate portion of the spinal column is depolarized and
myotome-sensing locations are selected according to the physiology
of the associated nerves for portion of the spinal column of
interest. In exemplary aspects, therefore, preferred
myotome-sensing locations may therefore include locations on the
patient's arms, anal sphincter, bladder, and other areas, depending
upon the vertebrae level where the spinal surgery is to be
performed.
[0059] In a preferred aspect, the current level of the stimulus
signal conducted between status electrodes 11 and 13 (or 12 and 14)
is incrementally increased in a staircase fashion as shown in the
current staircase of FIG. 2 from a low value until an onset EMG
response is detected at one or more myotome locations. In a
preferred embodiment, onset EMG response peak-to-peak value is
between 60 mV and 80 mV. (It is noted, however, that depending on
the location the stimulating electrode relative to the nerve
corresponding to a myotome and the nerve health/status, an onset
EMG response may not be detected as the current level is
incremented from the lowest level to the highest level shown in
FIG. 2.) In the illustrated exemplary aspect, the current level is
shown as increasing from 4 mA to 32 mA, in eight 4 mA increments
where the current level is incremented until an onset EMG response
is detected. The present invention is not limited to these values
and other current ranges (and other numbers "steps" in the
staircase) may also be used, as is desired.
[0060] At lower current levels, an onset neuro-muscular (i.e., EMG)
responses to the stimulus pulse may not be detected at each myotome
ML1 to MR3 location. However, as the current level of the stimulus
signal is incrementally increased (i.e.: moving up the staircase,
step-by-step), an onset neuro-muscular (i.e., EMG) response may
eventually be detected at each of the various myotome locations ML1
through MR3 for each of the six associated spinal nerves. As noted
whether an onset EMG response is detected for myotome depends on
the location of the electrode relative to the corresponding nerve
and the nerve status/health. For example, when a nerve is
compressed or impaired, the current level required to generate an
onset EMG response may be greater than the similar, non-compressed
nerve at a similar distance from the stimulating electrode.
Accordingly, he onset neuro-muscular response for each of the
various myotome ML1 to MR3 locations may be elicited at different
stimulus current levels due at least in part to the various
individual spinal nerves being compressed, impaired, etc., and also
due simply to differences in the individual nerve pathway
sensitivities.
[0061] For example, referring to the example illustrated in FIG. 1,
a stimulus signal having an initial current level is conducted
between electrodes 11 and 13 (or between electrodes 12 and 14). The
current level of the stimulus pulse is increased step-by-step
according to the intensity staircase shown in FIG. 2 until an onset
EMG response is detected at one or more selected myotomes. In
particular, a response to the increasing current level stimulus
pulse is detected at each of the various myotome locations ML1
through MR3. Because each of the spinal nerve paths corresponding
to the various myotome locations ML1 through MR3 may have different
sensitivities (as noted), different onset EMG responses may be
detected at the different onset current levels for different
myotome locations.
[0062] For example, Table 1 illustrates the current level required
to elicit an onset EMG response for myotome location. As seen in
Table 1, myotome location ML1 detected an onset EMG response to the
stimulus pulse for a current level of 4 mA. Similarly, myotome MR2
detected an onset neuro-muscular/EMG response to the stimulus pulse
for a current level of 24 mA, etc. Summarizing in tabular form:
TABLE-US-00001 TABLE 1 Stimulus Current Level at Which Onset EMG
Response is Detected: ML1 - 4 mA MR1 - 16 mA ML2 - 16 mA MR2 - 24
mA ML3 - 20 mA MR3 - 12 mA
[0063] The above detected stimulus current levels may then be
optionally scaled to correspond to stimulus staircase levels 1
through 8, with the maximum signal strength of 32 mA corresponding
to "8", as follows, and as illustrated for each of Myotome
locations ML1 to MR3, as shown in Table 2 based on the levels shown
in Table 1.
TABLE-US-00002 TABLE 2 Scaled Neuro-muscular Response Onset Values:
ML1 - 1 MR1 - 4 ML2 - 4 MR2 - 6 ML3 - 5 MR3 - 3
[0064] Accordingly, by depolarizing a portion of the patient's
cauda equina and by then measuring the current amplitude at which
an onset neuro-muscular (i.e., EMG) response to the depolarization
of the cauda equina is detected in each of a plurality of spinal
nerves, (i.e.: at each of the myotome locations corresponding to
each of the individual spinal nerves), a method for determining the
relative neuro-muscular response for each of the plurality of
spinal nerves is provided. As such, the relative sensitivities of
the various spinal nerve pathways with respect to one another can
initially be determined. This information may represent the
relative health or status of the nerves coupled to each myotome
location where the stimulating electrode is approximately the same
distance from each of the corresponding nerves. For example, the
nerve corresponding to myotome location MR2 required 24 mA to
elicit an onset EMG response in the corresponding muscle.
Accordingly, this nerve may be compressed or otherwise
physiologically inhibited.
[0065] These respective stimulus pulse current levels at which an
onset neuro-muscular response is detected for each of myotome
locations ML1 through MR3 are detected may then be electronically
stored (as an initial "baseline" set of onset EMG response current
levels). In a preferred aspect, these stored levels may then be
used to perform nerve detection for a probe at a location other
than the midline as will be explained. As noted, once an onset
neuro-muscular or EMG-response has been detected for each of the
myotome locations, it is not necessary to apply further increased
current level signals. As such, it may not be necessary for the
current level of the signal to reach the top of the current level
staircase (as shown in FIG. 2) (provided a response has been
detected at each of the myotome locations).
[0066] By either reaching the end of the increasing current
amplitude staircase, (or by simply proceeding as far up the
staircase as is necessary to detect a response at each myotome
location), the present system obtains and stores an initial
"baseline" set of current level onset values for each myotome
location. These onset values may be stored either as absolute
(i.e.: mA) or scaled (i.e.: 1 to 8) values. As noted these values
represent the baseline or initial nerve status for each nerve
corresponding to one of the myotome locations. This baseline onset
current level may be displayed as a fixed value on a bar graft of
LEDs such as shown in FIG. 8A or 8B. At a later point, the nerve
status of the nerves corresponding to the myotomes may be
determined again by applying a varying current level signal to the
midline electrodes. If a procedure is being performed on the
patient, the onset current level for one or more of the
corresponding nerves may change.
[0067] When the onset current level increases for a nerve this may
indicate that a nerve has been impacted by the procedure. The
increased onset current level may also be displayed on the bar
graft for the respective myotome (FIG. 8A/8B). In one embodiment,
the baseline onset current level is shown as a particular color LED
in the bar graph for each myotome location and the increased onset
current level value is shown as a different color LED on the bar
graph. When the onset current level decreases for a nerve this may
indicate that a nerve has been aided by the procedure. The
decreased onset current level may also be displayed on the bar
graft for the respective myotome. In a preferred embodiment, the
decreased onset current level value is shown as a third color LED
on the bar graph. When the onset current level remains constant,
only the first color for the baseline onset current level is shown
on the bar graph. In one embodiment, a blue LED is depicted for the
baseline onset current level, an orange LED is depicted for an
increased (over the baseline) onset current level, and a green LED
is depicted for a decreased onset current level. In one embodiment
when the maximum current level in the staircase does not elicit an
onset EMG response for a myotome, the baseline LED may be set to
flash to indicate this condition. Accordingly, a clinician may
periodically request nerve status (midline stimulation) readings to
determine what impact, positive, negative, or neutral, a procedure
has had on a patient. The clinician can make this assessment by
viewing the bar graphs on the display shown in FIG. 8 for each of
the myotome locations.
[0068] The above determined initial set baseline neuro-muscular
response onset current levels for each nerve pathway (myotome
location) may then be used in the first (i.e.: nerve sensing)
aspect of the present invention, in which a system is provided for
detecting the presence of a spinal nerve adjacent to the distal end
of a single probe 20, or either of probes 20 or 22. (It is to be
understood, however, that the forgoing nerve status system (which
may experimentally determine neuro-muscular response onset values)
is an optional aspect of the present nerve detection system. As
such, it is not necessary to determine such relative or absolute
neuro-muscular response baseline onset current levels as set forth
above prior to nerve detection. Rather, generally expected or
previously known current onset levels may instead be used instead.
Such generally expected or previously known current onset levels
may have been determined by experiments performed previously on
other patients.
[0069] In accordance with the first aspect of the present
invention, nerve detection (performed as the surgical tool or probe
is advancing toward the operative site), or nerve surveillance
(performed in an ongoing fashion when the surgical tool or probe is
stationary has already reached the operative site) may be carried
out, as follows.
[0070] The first (nerve detection/surveillance) aspect of the
invention will now be set forth.
[0071] Returning to FIG. 1, a system is provided to determine
whether a nerve is positioned closely adjacent to either of two
probes 20 and 22. In accordance with the present invention, probes
20 and 22 can be any manner of surgical tool, including
(electrified) cannulae through which other surgical tools are
introduced into the patient. In one aspect of the invention only
one probe (e.g.: probe 20) is used. In another aspect, as
illustrated, two probes (e.g.: 20 and 22) are used. Keeping within
the scope of the present invention, more than two probes may also
be used. In one preferred aspect, probe 20 is an electrified
cannula and probe 22 is a "confirmation electrode" which can be
inserted through cannula/probe 20, as will be explained. Probes 20
and 22 may have electrified distal ends, with electrodes 21 and 23
positioned thereon, respectively, which is shown schematically in
FIGS. 9A and 9B. (In the case of probe 20 being a cannula,
electrode 21 may be positioned on an electrified distal end of the
cannula, or alternatively, the entire surface of the electrified
cannula may function as the electrode).
[0072] Nerve detection is accomplished as follows. A stimulus pulse
is passed between electrode 21 (disposed on the distal end of a
probe 20) and patient return electrode 30. In instances where a
second probe (22) is also used, a stimulus pulse is passed between
electrode 23 (disposed on the distal end of a probe 22) and patient
return electrode 30. In one aspect, electrodes 21 or 23 operate as
cathodes and patient return electrode 30 is an anode. In this case,
probes 20 and 22 are monopolar. Preferably, when simultaneously
using two probes (20 and 22) the stimulus pulse emitted by each of
electrodes 21 and 23 is multiplexed, so as to distinguish between
their signals.
[0073] It should be understood that electrodes 21 and 23 could be
replaced by any combination of multiple electrodes, operating
either in monopolar or bipolar mode. In the case where a single
probe has multiple electrodes (replacing a single electrode such as
electrode 21) probe 20 could instead be bi-polar with patient
return electrode 30 no longer being required.
[0074] Subsequent to the emission of a stimulus pulse from either
of electrodes 21 or 23, each of myotome locations ML1 through MR3
are monitored to determine if they exhibit an EMG response.
[0075] In a preferred aspect, as shown in FIG. 3, the intensity of
the stimulus pulse passing between electrodes 21 and 30 or between
22 and 30 is preferably varied over time. Most preferably, the
current intensity level of the stimulus pulse is incrementally
increased step-by-step in a "staircase" fashion. As can be seen,
the current may be increased in ten 0.5 mA steps from 0.5 mA to 5.0
mA. This stimulus pulse is preferably increased one step at a time
until a neuro-muscular (i.e., EMG) response to the stimulus pulse
is detected in each of myotome locations ML1 through MR3.
[0076] For myotome locations that exhibit an EMG response as a
result of the stimulus pulse, the present invention then records
the lowest amplitude of current required to elicit such a response.
Subsequently, this stimulus level is interpreted so as to produce
an appropriate warning indication to the user that the surgical
tool/probe is in close proximity to the nerve.
[0077] For example, in a simplified preferred aspect, the staircase
of stimulus pulses may comprise only three levels, (rather than the
8 levels which are illustrated in FIG. 3). If an EMG response is
recorded at a particular myotome location for only the highest
level of stimulation (i.e.: the third step on a 3-step staircase),
then the system could indicate a "low" alarm condition (since it
took a relatively high level of stimulation to produce an EMG
response, it is therefore unlikely that the tool/probe distal
tip(s) are in close proximity to a nerve). If an EMG response is
instead first recorded when the middle level of stimulation (i.e.:
the second step on the 3-step staircase) is reached, then the
system could indicate a "medium" alarm condition. Similarly, if an
EMG response is recorded when the lowest level of stimulation
(i.e.: the first step on the 3-step staircase) is reached, then it
is likely that the probe tips(s) are positioned very close to a
nerve, and the system, could indicate a "high" alarm condition.
[0078] As can be appreciated, an important advantage of increasing
the stimulus current intensity in a "staircase" function,
increasing from lower to higher levels of current intensity is that
a "high" alarm condition would be reached prior to a "low" alarm
condition being reached, providing an early warning to the surgeon.
Moreover, as soon as a "high" alarm condition is reached, the
present invention need not continue through to the end (third step)
of the staircase function. In preferred aspects, when the current
level of the applied signal to the probe (20 or 22) elicits an EMG
response greater than the pre-determined onset EMG response, the
current level is not increased.
[0079] In the above-described simplified (only three levels of
stimulation) illustration of the invention, it was assumed that all
nerves respond similarly to similar levels of stimulation, and the
proximity (nerve detection) warning was based upon this assumption.
Specifically, in the above-described simplified (three levels of
stimulation) illustration, there was an assumed one-to-one (i.e.
linear) mapping of the EMG onset value data onto the response data
when determining what level of proximity warning indication should
be elicited, if any. However, in the case of actual spinal nerve
roots, there is not only a natural variability in response onset
value threshold, but there is often a substantial variation in
neuro-muscular response onset values between the nerve pathways
caused as a result of certain disease states, such as nerve root
compression resulting from a herniated intervertebral disc.
[0080] Accordingly, in a preferred aspect of the present invention,
the initial "baseline" neuro-muscular EMG response onset value data
set which characterizes the relative EMG onset values of the
various nerve roots of interest, (as described above), is used to
guide the interpretation of EMG response data and any subsequent
proximity warning indication, as follows.
[0081] Referring back to FIG. 1 and Table 1, the stimulation
staircase transmitted between electrodes 11 and 13 (or 12 and 14)
resulted in measures neuro-muscular (i.e.: EMG) response onset
values of 4, 16, 20, 16, 24 and 12 mA at myotome locations ML1,
ML2, ML3, MR1, MR2 and MR3, respectively. As can be seen, twice the
intensity of current was required to produce a neuro-muscular
response at MR2 as was required to produce a neuro-muscular
response at MR3 (since "24" mA is twice as big as "12" mA). Thus,
the nerve pathway to MR3 is more "sensitive" than to MR2 (since MR3
is able to exhibit a neuro-muscular response at 1/2 of the current
intensity required to exhibit a neuro-muscular response at MR2).
Consequently, during nerve detection, when electrode 21 or 23
(positioned on the distal end of tool/probe 20 or 22) is positioned
adjacent the nerve root affiliated with MR3, twice the current
stimulation intensity was required to produce an EMG response. In
contrast, when electrode 21 or 23 (on the distal end of tool/probe
20 or 22) was positioned adjacent to the nerve root affiliated with
MR2, the same level of stimulation that produced a response at MR3
would not produce a response at MR2.
[0082] In accordance with preferred aspects of the present
invention, the sensitivities of the various spinal nerve pathways
(to their associated myotomes) are incorporated into the nerve
detection function of the invention by incorporating the various
neuro-muscular response onset values, as follows.
[0083] A decision is made that either of electrodes 21 or 23 are
positioned adjacent to a spinal nerve when a neuro-muscular
response is detected at a particular myotome location at a current
intensity level that is less than, (or optionally equal to), the
previously measured or input EMG response onset value for the
particular spinal nerve corresponding to that myotome. For example,
referring to myotome location ML1, the previously determined
neuro-muscular response onset level was 4 mA, as shown in Table 1.
Should a neuro-muscular response to the stimulus pulse be detected
at a current intensity level at or below 4 mA, this would signal
the operator that the respective probe electrode 21 (or 23)
emitting the stimulus pulse is in close proximity to the spinal
nerve.
[0084] Similarly, the neuro-muscular response onset value for
myotome location ML2 was determined to be 16 mA, as shown in Table
1. Accordingly, should a neuro-muscular response be detected at a
current intensity level of less than or equal to 16 mA, this would
indicate that respective probe electrode 21 (or 23) emitting the
stimulus pulse is in close proximity to the spinal nerve.
[0085] In addition, as illustrated in FIG. 4, "high", "medium" and
"low" warning levels may preferably be mapped onto each stimulation
staircase level for each myotome location. For example, the
neuro-muscular onset level for ML1 was 4 mA, corresponding to the
first level of the 8-level status electrode current staircase of
FIG. 2. Thus, the first (4 mA) step on the staircase is assigned a
"high" warning level. Level two (8 mA) is assigned a "medium"
warning level and level three (12 mA) is assigned a "low" warning
level. Thus, if an EMG response is recorded at ML1 at the first
stimulation level, (4 mA), a "high" proximity warning is given. If
a response is detected at the second level (8 mA), then a "medium"
proximity warning is given. If a response is detected at the third
level (12 mA), then a "low" proximity warning is given. If
responses are detected only above the third level, or if no
responses are detected, than no warning indication is given.
[0086] Similarly, for ML2, with a onset value of 16 mA, (i.e.: the
fourth level in the status electrode current staircase sequence),
the "high", "medium" and "low" warning levels are assigned starting
at the fourth step on the status electrode current staircase, with
the fourth step being "high", the fifth level being "medium" and
the sixth level being "low", respectively, as shown. Accordingly,
if an EMG response is detected for ML2 at (or above) the first,
second, third, or fourth surveillance levels, (i.e.: 4, 18, 12 or
16 mA), then a "high" warning indication will be given. For a
response initially detected at the fifth level (i.e.: 20 mA), then
a "medium" warning indication is given. If a response is not
detected until the sixth level (i.e.: 24 mA), then a "low" warning
indication is given. If responses are detected only above the sixth
level, or not at all, then no indication is given. Preferably, each
of myotome locations ML1 through MR3 are monitored at conditions
indicating "high", "medium" and "low" likelihood of a nerve being
disposed adjacent the surgical tool/probe.
[0087] As can be seen in FIG. 4, ten levels are shown for each of
the myotome locations, whereas the illustrated status electrode
current staircase has only eight levels. These optional levels "9"
and "10" are useful as follows. Should scaled level 8 be the
minimum onset level at which a neuro-muscular response is detected,
levels "9" and "10" can be used to indicate "medium" and "low"
warning levels, respectively.
[0088] As explained above, the various neuro-muscular response
current onset levels used in detection of spinal nerves may either
have been either determined in accordance with the second aspect of
the present invention, or may simply correspond to a set of known
or expected values input by the user, or pre-set into the system's
hardware/software. In either case, an advantage of the present
system is that different neuro-muscular response onset value levels
may be used when simultaneously sensing for different nerves. An
advantage of this is that the present invention is able to
compensate for different sensitivities among the various spinal
nerves.
[0089] As can be seen comparing the current intensities of stimulus
electrodes 11 and 13 (or 12 and 14) as shown in FIG. 2 (i.e.: up to
32 mA) to the current intensities of probe electrodes 21 and 23 as
shown in FIG. 3 (i.e.: up to 5.0 mA), the current intensities
emitted by probe electrodes 21 and 23 are less than that of
electrodes 12 and 14. This feature of the present invention is very
advantageous in that electrodes 21 and 23 are positioned much
closer to the spinal nerves. As such, electrodes 21 and 23 do not
depolarize a large portion of the cauda equina, as do electrodes 12
and 14. In addition, the placement of electrode 11 in the epidural
space ensures that the electrode is at a relatively known distance
from the spinal nerves.
[0090] In an optional preferred aspect of the invention, if a
neuro-muscular response (greater than the onset EMG response) is
detected for all six myotome sensing locations ML1 through MR3
before all of the steps on the staircase is completed, the
remaining steps need not be executed.
[0091] Moreover, if it has been determined that a maximal level of
stimulation is required to elicit an EMG response at a particular
myotome sensing location, then only the top three stimulation
levels need to be monitored during the neuro-muscular response
detection sequence. In this case, the top three monitored levels
will correspond to "high", "medium", and "low" probabilities of the
surgical tool/probe being disposed adjacent the a nerve. In another
optional aspect, if any of the myotome locations do not respond to
the maximum stimulation level (i.e.: top step on the staircase),
they are assigned the maximum scale value (i.e.: a "low" warning
indication).
[0092] Preferably, each of the spinal nerves monitored at myotome
locations ML1 through MR3 will correspond to nerves exiting from
successive vertebrae along the spine. For example, as shown in FIG.
5, a main spinal nerve 50 will continuously branch out downwardly
along the spinal column with spinal nerve 51 exiting between
vertebrae L2 and L3 while nerve 52 passes downwardly. Spinal nerve
53 exits between vertebrae L3 and L4 while spinal nerve 54 passes
downwardly to L4. Lastly, spinal nerve 55 will exit between
vertebrae L4 and L5 while spinal nerve 56 passes downwardly. As can
be seen, neuro-muscular (i.e., EMG) response measurements taken at
myotome location MR1 will correspond to EMG signals in spinal nerve
51, response measurements taken at myotome location MR2 correspond
to EMG signals in spinal nerve 53, and response measurements taken
at myotome location MR3 correspond to EMG signals in spinal nerve
55.
[0093] In accordance with the present invention, the detection of a
neuro-muscular (EMG) response, whether in accordance with the first
(i.e.: nerve detection), or second (i.e.: establishing initial
"baseline" neuro-muscular response onset values) aspect of the
invention, may be accomplished as follows.
[0094] Referring to FIG. 6, an illustration of the waveform
characteristics of a stimulus pulse and a corresponding
neuro-muscular (EMG) response as detected at a myotome location is
shown. An "EMG sampling window" 200 may be defined at a fixed
internal of time after the stimulus pulse 202 is emitted. The
boundaries of window 200 may be determined by the earliest and
latest times that an EMG response may occur relative to stimulus
pulse 202. In the case of stimulation near the lumbar spine, these
times are, for example, about 10 milliseconds and 50 milliseconds,
respectively.
[0095] During EMG sampling window 101, the EMG signal may
optionally be amplified and filtered in accordance with guidelines
known to those skilled in the art. The signal may then be rectified
and passed through a threshold detector to produce a train of
pulses representing the number of "humps" of certain amplitudes
contained in the EMG waveform. A re-settable counting circuit may
then count the number of humps and a comparator may determine
whether the number of pulses is within an acceptable range. By way
of example only, the number of acceptable pulses for EMG responses
elicited by stimulation in the lumbar spine region may range from
about two to about five. If only one pulse is counted, then it is
unlikely that a true EMG response has occurred, since true EMG
waveforms are typically biphasic (having at least one positive
curved pulse response and one negative curved pulse response)
resulting in at least two pulses. This pulse-counting scheme helps
to discriminate between true EMG waveforms and noise, since noise
signals are typically either sporadic and monophasic (and therefore
produce only one pulse) or repetitive (producing a high number of
pulses during the EMG sampling window).
[0096] In a further optional refinement, a separate noise-sampling
window may be established to remove noise present in the EMG
responses to increase the ability of the system to discriminate
between true EMG responses and false responses caused by noise. The
boundaries of noise sampling window are chosen such that there is
no significant change of a true EMG signal occurring during the
window. For example, it may be deemed acceptable that one curved
pulse of an EMG response may be comprised primarily of noise, but
if more than one curved pulse of an EMG response is primarily
comprised of noise, an alarm would be triggered indicating that
excess noise is present on that particular channel.
[0097] In preferred aspects of the present invention, both the
optional second aspect of determining the neuro-muscular response
onset values for each of the plurality of spinal nerves and the
first aspect of sensing to detect if a nerve is positioned adjacent
to a surgical tool/probe are repeated over time. Preferably, the
sensing of whether a nerve is positioned adjacent to a surgical
tool/probe is continuously repeated in very short intervals of
time, such that the operator can be warned in real time as the
surgical tool/probe is advanced toward the nerve. The present
system of determining the neuro-muscular response onset values for
each of the plurality of spinal nerves is also preferably repeated,
and may be repeated automatically, or under operator control.
[0098] Typically, the above two aspects of the present invention
will not be carried out simultaneously. Rather, when the
neuro-muscular response onset values are being determined (using
electrodes 11 and 13 or 12 and 14), the operation of probe
electrodes 21 and 23 will be suspended. Conversely, when sensing to
determine whether a nerve is positioned adjacent either of probes
20 or 22, the operation of stimulation electrodes 11 and 13 or 12
and 14 will be suspended. A standard reference electrode 32 may be
used for grounding the recording electrodes at the myotomes.
[0099] FIG. 6 depicts a particular exemplary embodiment of the
present invention. Other embodiments are also possible, and are
encompassed by the present invention. Pulse generator 100 creates
pulse trains of an appropriate frequency and duration when
instructed to do so by controller 118. By way of example, the pulse
frequency may be between 1 pulse-per-second and 10
pulses-per-second, and the pulse duration may be between 20 .mu.sec
and 300 .mu.sec. Pulse generator 100 may be implemented using an
integrated circuit (IC), such as an ICL75556 (Intensity) or
generated by a software module. Amplitude modulator 102 produces a
pulse of appropriate amplitude as instructed by controller 118, and
may comprise a digital-to-analog converter such as a DAC08
(National Semiconductor). The output of amplitude modulator 102
drives output stage 103, which puts out a pulse of the desired
amplitude. Output stage 103 may comprise a transformer coupled,
constant-current output circuit. The output of output stage 103 is
directed through output multiplexer 106 by controller 118 to the
appropriate electrodes, either to status (baseline) electrodes 11
and 13, or to a combination of screw test probe 109, probe
electrode 21, 23 and patient return electrode 13. Impedance monitor
104 senses the voltage and current characteristics of the output
pulses and controller 118 elicits an error indication on error
display 127 if the impedance falls above or below certain pre-set
limits. Input keys 116 may be present on a front panel of a control
unit of the present invention, as depicted in FIG. 8, to allow the
user to shift between modes of operation.
[0100] EMG inputs 128 to 138 comprise the six pairs of electrodes
used to detect EMG activity at six different myotome locations. It
will be appreciated that the number of channels may vary depending
upon the number of nerve roots and affiliated myotomes that need to
be monitored. A reference electrode 140 may also be attached to the
patient at a location roughly central to the groupings of EMG
electrodes 128 to 138 to serve as a ground reference for the EMG
input signals. Electrodes 128 to 140 may either be of the
needle-type or of the gelled foam type, or of any type appropriate
for detecting low-level physiological signals. EMG input stage 142
may contain input protection circuit comprising, for example, gas
discharge elements (to suppress high voltage transients) and/or
clamping diodes. Such clamping diodes are preferably of the
low-leakage types, such as SST-pads (Siliconix). The signal is then
passed through amplifier/filter 144, which may amplify the signal
differentially using an instrumentation amplifier such as an AD620
(Analog Devices). The overall gain may be on the order of about
10,000:1 to about 1,000,000:1, and the low and high filter bands
may be in the range of about 1-100 Hz and 500 to 5,000 Hz,
respectively. Such filtering may be accomplished digitally, in
software, or with discrete components using techniques well known
to those skilled in the art. The amplified and filtered signal then
passes through rectifier 141, which may be either a software
rectifier or a hardware rectifier. The output of rectifier 146 goes
to threshold detector 147 which may be implemented either in
electronic hardware or in software. The output of threshold
detector 147 then goes to counter 148 which may also be implemented
by either software or hardware.
[0101] Controller 118 may be a microcomputer or microcontroller, or
it may be a programmable gate array, or other hardware logic
device. Display elements 120 to 127 may be of any appropriate type,
either individually implemented (such as with multicolor LEDs) or
as an integrated display (such as an LCD).
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