U.S. patent application number 13/565118 was filed with the patent office on 2012-11-22 for neurologic monitoring system and method.
Invention is credited to Hyun Woo Bae, Timothy Taylor Davis.
Application Number | 20120296230 13/565118 |
Document ID | / |
Family ID | 43062773 |
Filed Date | 2012-11-22 |
United States Patent
Application |
20120296230 |
Kind Code |
A1 |
Davis; Timothy Taylor ; et
al. |
November 22, 2012 |
NEUROLOGIC MONITORING SYSTEM AND METHOD
Abstract
A method, system, and products that allow for accurate
localization, virtual depiction, and testing of nerve(s) or neural
structures that course through or around a proposed surgical site
are described. The method and system employs a variety of types of
neurodiagnostic tests that incorporate sensory, motor, and mixed
nerve conduction studies in an orthodromic and antidromic fashion
as well as utilizing triggered electromyography. This method,
system, and products allow for a much more specific and sensitive
method to assess the baseline function and continued integrity of
nerves and neural structures prior to, during, and after a surgical
procedure.
Inventors: |
Davis; Timothy Taylor;
(Santa Monica, CA) ; Bae; Hyun Woo; (Santa Monica,
CA) |
Family ID: |
43062773 |
Appl. No.: |
13/565118 |
Filed: |
August 2, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12775171 |
May 6, 2010 |
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13565118 |
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61286703 |
Dec 15, 2009 |
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61177181 |
May 11, 2009 |
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Current U.S.
Class: |
600/546 ;
600/554; 606/129 |
Current CPC
Class: |
A61B 5/04001 20130101;
A61B 5/0488 20130101 |
Class at
Publication: |
600/546 ;
606/129; 600/554 |
International
Class: |
A61B 5/05 20060101
A61B005/05; A61B 5/0488 20060101 A61B005/0488 |
Claims
1. A method for monitoring neural function of a target nerve with
the use of a neuromonitoring machine, the method comprising:
providing a stimulus to a proximal nerve and obtaining a response
at a distal nerve; providing a stimulus to a distal nerve and
obtaining a response at a proximal nerve, wherein the distal nerve
is distal to the target nerve and the proximal nerve is proximal to
the target nerve; and comparing the distal nerve response or the
proximal nerve response to a baseline response.
2. The method of claim 1, further comprising placing a proximal
electrode at or in proximity to the proximal nerve and placing a
distal electrode at or in proximity to the distal nerve.
3. The method of claim 2, further comprising receiving a response
with the proximal electrode and providing a stimulus with the
proximal electrode.
4. The method of claim 2, further comprising receiving a response
with the distal electrode and providing a stimulus with the distal
electrode.
5. The method of claim 1, wherein the baseline response is a
measurement of the target nerve function when the target nerve is
not under compression or traction.
6. The method of claim 1, wherein the proximal nerve is a L1, L2,
or L3 nerve root.
7. The method of claim 1, wherein the distal nerve is a nerve
corresponding to a dermatome, a myotome, or a femoral nerve.
8. The method of claim 1, further comprising obtaining one or more
of nerve conduction velocity, elapsed time between stimulus and
response, nerve latency time, or response amplitude.
9. The method of claim 1, further comprising diminishing traction
or compressive forces on the target nerve when the distal nerve
response or the proximal nerve response is not substantially the
same to the baseline response.
10. The method of claim 1, further comprising testing sensory
nerves orthodromically and antidromically.
11. The method of claim 1, further comprising testing sensory
nerves, motor nerves, or mixed neural structures having sensory and
motor nerves.
12. The method of claim 1, further comprising conducting
electromyography.
13. A system for monitoring neural function of a nerve, comprising:
a first electrode configured to be suitable for nerve stimulus
delivery and nerve response recordation; a first slave box
connected to the first electrode, the slave box further comprising
electrical stimulus circuitry and amplification circuitry to either
deliver a stimulus to the first electrode via the stimulus
circuitry or to receive a response from the first electrode via the
amplification circuitry; and a first switch having a first position
to connect the first electrode to the electrical stimulus circuitry
and disconnect the first electrode from the amplification circuitry
to allow delivery of a nerve stimulus at the first electrode, and a
second position to connect the first electrode to the amplification
circuitry and disconnect the first electrode from the electrical
stimulus circuitry to allow recording a nerve response at the first
electrode.
14. The system of claim 13, wherein the switch is a hard wired
switch or a software switch.
15. The system of claim 13, further comprising a neuromonitoring
machine that controls the connection of the first electrode to the
stimulus circuitry and to the amplification circuitry.
16. The system of claim 13, comprising a hard switch that controls
the connection of the first electrode to the stimulus circuitry and
the amplification circuitry.
17. The system of claim 13, further comprising a ground electrode
connected to the amplification circuitry.
18. The system of claim 13, wherein in the first switch position
the first electrode is connected to an anode in the stimulus
circuitry, and the switch in the second position connects the first
electrode to an active contact in the amplification circuitry.
19. The system of claim 13, wherein the amplification circuitry
comprises differential amplification circuitry.
20. The system of claim 13, wherein the system further comprises a
neuromonitoring machine configured to automatically connect the
first electrode to the electrical stimulus circuitry, and
automatically connect the first electrode to the amplification
circuitry.
21. The system of claim 20, further comprising a second electrode
configured to be suitable for nerve stimulus delivery and nerve
response recordation; a second slave box connected to the second
electrode, the second slave box further comprising second
electrical stimulus circuitry and second amplification circuitry to
either deliver a stimulus to the second electrode via the second
stimulus circuitry or to receive a response from the second
electrode via the second amplification circuitry; and a second
switch having a first position to connect the second electrode to
the second electrical stimulus circuitry and disconnect the second
electrode from the second amplification circuitry to allow delivery
of a nerve stimulus at the second electrode, and a second position
to connect the second electrode to the second amplification
circuitry and disconnect the second electrode from the second
electrical stimulus circuitry to allow recording a nerve response
at the second electrode, and the neuromonitoring machine is
configured to automatically connect the second electrode to the
amplification circuitry of the second slave box when the first
electrode is connected to the electrical stimulus circuitry of the
first slave box, and to automatically connect the second electrode
to the electrical stimulus circuitry of the second slave box when
the first electrode is connected to the amplification circuitry of
the first slave box.
22. The system of claim 13, further comprising an electrode with a
plurality of independent contacts at a distal tip of the electrode,
wherein the electrode is electrically coupled to the slave box, and
each of the contacts is provided at a different location of the
electrode.
23. The system of claim 21, further comprising a third electrode
connected to the first slave box and a fourth electrode connected
to the second slave box, wherein the first switch is in the first
position and connects the first and third electrodes to the
electrical stimulus circuitry of the first slave box, and the
second switch is in the second position and connects the second and
fourth electrodes to the amplification circuitry of the second
slave box.
24. The system of claim 21, further comprising a third electrode
connected to the first slave box and a fourth electrode connected
to the second slave box, wherein the first switch is in the second
position and connects the first and third electrodes to the
amplification circuitry of the first slave box, and the second
switch is in the first position and connects the second and fourth
electrodes to the electrical stimulus circuitry of the second slave
box.
25. The system of claim 13, further comprising a second electrode
connected to the slave box, wherein the switch being in the first
position connects the second electrode to the electrical stimulus
circuitry and disconnects the second electrode from the
amplification circuitry, and the switch being in the second
position connects the second electrode to the amplification
circuitry and disconnects the second electrode from the electrical
stimulus circuitry.
26. The system of claim 25, wherein the electrical stimulus
circuitry comprises a cathode and anode, and the switch being in
the first position connects the first electrode to the cathode and
the second electrode to the anode.
27. The system of claim 25, wherein the amplification circuitry
includes a reference contact and an active contact, and the switch
being in the second position connects the first electrode to the
reference contact and the second electrode to the active
contact.
28. The system of claim 13, further comprising a second electrode
configured to be suitable for nerve stimulus delivery and nerve
response recordation; a second slave box connected to the second
electrode, the second slave box further comprising second
electrical stimulus circuitry and second amplification circuitry to
either deliver a stimulus to the second electrode via the second
stimulus circuitry or to receive a response from the second
electrode via the second amplification circuitry; and a second
switch having a first position to connect the second electrode to
the second electrical stimulus circuitry and disconnect the second
electrode from the second amplification circuitry to allow delivery
of a nerve stimulus at the second electrode, and a second position
to connect the second electrode to the second amplification
circuitry and disconnect the second electrode from the second
electrical stimulus circuitry to allow recording a nerve response
at the second electrode.
29. The system of claim 28, further comprising a third electrode
connected to the first slave box and a fourth electrode connected
to the second slave box, wherein the first switch is in the first
position and connects the first and third electrodes to the
electrical stimulus circuitry of the first slave box, and the
second switch is in the second position and connects the second and
fourth electrodes to the amplification circuitry of the second
slave box.
30. The system of claim 28, further comprising a third electrode
connected to the first slave box and a fourth electrode connected
to the second slave box, wherein the first switch is in the second
position and connects the first and third electrodes to the
amplification circuitry of the first slave box, and the second
switch is in the first position and connects the second and fourth
electrodes to the electrical stimulus circuitry of the second slave
box.
31. A localization probe for detecting the location of a nerve,
comprising: a shaft having a distal end and a proximal end; and an
active tip on the distal end, wherein the active tip has an exposed
portion of an electroconductive material surrounded by insulation,
and the active tip is configured to rotate.
32. The probe of claim 31, wherein the active tip defines a
circumference having a portion of the circumference formed from the
electroconductive material and the remainder of the circumference
is formed from insulation.
33. The probe of claim 31, wherein the electroconductive material
extends the length of the probe and is connected to a stimulus
circuit.
34. A method for monitoring a nerve with the use of a
neuromonitoring machine, comprising: obtaining a baseline response
of a neural structure by stimulating a nerve at a proximal location
and receiving a response at a distal location and stimulating a
nerve at a distal location and receiving a response at a proximal
location, the baseline response being defined as a response when
the neural structure is not experiencing surgical trauma; locating
the neural structure by providing stimulation in a unidirectional
manner and receiving a response from a nerve that is proximal to
the stimulation location and distal to the stimulation location;
causing compression or tension in proximity to the localized neural
structure while stimulating a nerve at a proximal location and
receiving a response at a distal location and stimulating a nerve
at a distal location and receiving a response at a proximal
location; and comparing the nerve responses obtained when the
medical device is in proximity to the localized neural structure
with the baseline response.
35. A neuromonitoring electrode, comprising: an electroconductive
core material; an insulator material surrounding the core material;
a blunt distal end having exposed core material; and a proximal end
having exposed core material, wherein the neuromonitoring electrode
is flexible.
36. An arc introducer apparatus, comprising: a rotating axis; and a
radius arm connected to the rotating axis, the radius arm
configured to connect to an arc introducer needle; wherein the arc
introducer apparatus is configured to be inserted over a
guidewire.
37. The arc introducer apparatus of claim 36, further comprising an
arc introducer needle on the radius arm on an opposite side to the
rotating axis.
38. The arc introducer apparatus of claim 37, wherein the radius
arm is rigid and essentially linear and the arc introducer needle
is rigid and has a radius of curvature.
39. A method for placing a neuromonitoring electrode within a
tissue of a body, comprising: placing a guidewire within a body to
reach a deep tissue; inserting the radius introducer apparatus of
claim 37 over the guidewire to be approximately flush to a surface
of the body; adjusting a radius arm of the radius introducer
apparatus to a length approximately equal to the depth of the
guidewire inside the body; pivoting the radius arm with the arc
introducer needle to insert the arc introducer needle to reach a
neural structure to be monitored; and inserting a flexible
neuromonitoring electrode through the arc introducer needle, and
removing the arc introducer needle to place the electrode at or
close to the neural structure to be monitored.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/775,171, filed May 6, 2010, which claims
the benefit of U.S. Provisional Application No. 61/286,703, filed
Dec. 15, 2009, and the benefit of U.S. Provisional Application No.
61/177,181, filed May 11, 2009, the disclosures of which are all
expressly incorporated herein by reference.
BACKGROUND
[0002] Surgery, particularly minimally invasive surgery, often
requires the use of retractors. A retractor is a medical instrument
that, when inserted in an incision or opening in the body, is used
to separate tissue to permit better visualization and access to the
underlying target of the surgery. Retractors will oftentimes expand
an initial skin incision to more than twice the original size and
cause compression to the surrounding tissue (neural, vascular, and
other soft tissue structures) in the process. Minimally invasive
surgery offers the advantages of decreased trauma, less
post-operative pain, faster recovery, and a smaller surgical scar.
Yet, studies have shown that the learning curve for minimally
invasive surgical techniques can be steep for even an experienced
spine surgeon. This leaves the possibility of complications and
unnecessarily long surgeries during the learning phase prior to the
development of an efficient technique. A minimally invasive
procedure will normally require a specialized retractor. These
specialized retractors allow good visualization of the target
tissue but, due to the small incision, do not allow adequate
visualization of the surrounding structures. It is known that
excessive compression or traction on neural structures as a result
of using a retractor may result in damage and permanent loss of
nerve function, which translates into pain, numbness, and weakness
post-operatively.
[0003] In lateral access spine surgery, an incision is made in the
flank and dissection is performed through the retroperitoneal space
and then through the psoas muscle to allow access to the spinal
column. A retractor is advanced through this same tract and then
expanded in the psoas muscle, revealing the spinal column. The
psoas muscle is traversed by the lumbar plexus (the neural bundle
that supplies the leg), and anatomic and clinical studies have
shown that branches of the lumbar plexus are in potential jeopardy
during a transpsoas spinal approach. Patients undergoing lateral
access transpsoas spine surgery have been reported to have neural
deficits post-operatively thirty percent of the time. It is
therefore necessary to identify contact and subsequent compression
or damage of a nerve(s) as it occurs during placement and expansion
of the retractor and throughout the course of a lateral access
surgery in the spine. Current intraoperative neuromonitoring
systems allow for testing of neural structures using a medical
instrument that is used in performance of the surgery. U.S. Patent
Application Publication No. 2005/0182454 discloses, for example, a
surgical system for electrically stimulating nerves via one or more
stimulation electrodes at the distal end of surgical access
components while monitoring the EMG responses of the muscle groups
innervated by the nerves. This is accomplished via 8 pairs of EMG
electrodes placed on the skin over the major muscle groups on the
legs. U.S. Pat. No. 6,466,817 discloses a system for detecting
proximity to a nerve and status of a nerve by providing a stimulus
to a calibration electrode and a proximity electrode. The system
includes EMG electrodes to receive the response after a stimulus is
applied to the calibration or proximity electrode. The calibration
electrode is positioned near a nerve. The proximity electrode may
be coupled to any medical device including a cannula, needle,
catheter, ablation device, laser, etc.
[0004] The above types of tests often give non-specific
neurodiagnostic changes during a surgery, which can be open to
interpretation. A neural pathway will conduct electrical impulses
from one end to the other whether created internally by the patient
or created externally by a method of neuromonitoring. The signals
can further degrade over increased lengths of a given pathway and
as the signals cross a synapse (nerve-nerve interface).
[0005] In contrast to prior art methods, the disclosed method and
apparatus include testing shorter segments of a neural pathway and,
in contrast to providing stimulation from a medical
device/electrode at the surgical site, the disclosed method tests
specifically, across a site of suspected injury or surgical site,
such as proximal to distal and vice versa. A shorter neural segment
will give a more reproducible reliable response.
SUMMARY
[0006] This summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the Detailed Description. This summary is not intended to identify
key features of the claimed subject matter, nor is it intended to
be used as an aid in determining the scope of the claimed subject
matter.
[0007] The present invention includes a system, products, and
related methods for identifying the location and testing the
performance of neural structures prior to surgery and protecting
neural structures during surgical procedures by detecting changes
in performance of the neural structures as they develop. Monitoring
nerve and nerve root for functional integrity or detecting injury
during a surgical procedure is disclosed by means of measuring
neural function of a segment of nerve that spans from a location
proximal of the surgical site to distal of the surgical site that
is the potential site of injury. This is performed prior to surgery
in order to obtain a "baseline" of normal neural function and is
performed multiple times and in opposing directions during the
procedure in order to verify continued normal neural function or
deterioration of function across the surgical site.
[0008] Disclosed is a neurodiagnostic system, which includes a
control unit, internally placed probes/electrodes in the patient,
combination slave boxes capable of both sending a stimulus to a
probe/electrode as well as receiving a signal from a recording
probe(s)/electrode(s), and a localization probe designed to send a
stimulus in order to detect neural structures during insertion to a
potential surgical site. The control unit consists of hardware,
software, and firmware, which has the capability of delivering a
stimulus as well as receiving a signal from recording electrodes on
or in the patient, converting this analog signal into digital
format and then into waveforms. The control unit is also capable of
identifying the relationship of a stimulus applied and a waveform
produced. The control unit and software is capable of performing
analysis of the waveforms and calculating conduction velocities,
elapsed times between stimulus and responses, latencies,
amplitudes, conduction velocity, or area of compound action
potential, and any combination or calculation using these values.
Baseline waveforms are stored and compared to future testing of the
same neural structure in order to detect changes in neural function
during a surgical procedure. The waveforms that are produced are
projected on a display screen on the control unit as well as to a
screen that the surgeon performing the surgery can visualize. The
control unit display can also be visualized by a remote supervisor
via a digital communication cable, such as a CAT 5, Ethernet line,
or any other variant of communication cable connected to a network
of any kind that stores, communicates, or moves digital
information.
[0009] In another aspect, a probe/electrode and method of inserting
the probe are provided that allow access to a point of the nerve
that has not been previously accessible due to the deep course of
the nerve through bone, muscle, and soft tissue structures. The
probe allows testing to be performed at a location deep inside the
body and proximal or distal to a surgical site. This function
cannot be performed using a "conventional" electromyography needle
that is currently on the market. The current needles are limited in
length and are not designed to bend. They also have a hub at the
surface end that would be easily bumped during surgery and pierce
the nerve during surgery. The disclosed probe/electrode is long
enough to enable tip proximity to the nerve or neural structures in
any patient regardless of the body habitus (size, girth of the
patient) or depth of the nerve course. Once the probe is in place,
it can then be bent to become flush with the surface of the skin to
ensure that the probe will not penetrate any deeper than the
desired placement. With current electromyography needles, the
length of the proximal portion of the needle cannot be modified
from patient to patient. Therefore, in a slender patient, there may
be a portion of the needle that is still exposed outside of the
skin and if bumped during the surgical procedure would impale the
nerve or neural structure to which it was adjacent. The disclosed
probe has a blunt tip. The disclosed probe can be located deep in
the tissue using an introducer needle with the aid of imaging
technology, such as fluoroscopy, CAT scan, and ultrasonic means,
for example. In another embodiment, the probe is sharp, and the
connection to the electrode wire is of minimal diameter, and the
probe can still be bent to a flush level with the skin. In this
embodiment, there is no need for the introducer needle.
[0010] In a further embodiment, the system uses a combination slave
box. The combination slave box is connected to the control unit and
is manipulated by a technician via a manual switch in one
embodiment of the system or via a remote electronic switch at the
control unit in another embodiment of the system. This slave box
has the capability of sending a stimulus through a specific
probe(s)/electrode(s) during one form of testing and then switching
function in order to work as an amplifier receiving a signal from a
recording probe(s)/electrode(s). For example, the slave box enables
the same probe to be used for both sending a stimulus in one test,
and receiving a signal in another test with the same probe. This
advantageously avoids having to disconnect and reconnect probes for
different tests.
[0011] In one embodiment, the system requires the technician to
switch electrodes from the designated slave stimulus box to the
designated amplifier box, and vice versa, during testing in order
to perform the neurodiagnostic studies that volley signals from one
location to another. These studies will be elaborated upon in the
description section of this document.
[0012] In a further embodiment, a localization probe is disclosed
that permits the localization of a neural structure. The
localization probe may be used to localize the neural structure
while a tract is made in the tissue where the retractor will later
be placed. By using the localization probe to guide the surgeon
around and away from the neural structure, the creation of the
tract is accomplished with minimal injury to the neural structure.
Furthermore, the tract will be created to avoid the neural
structure so that when the retractor is used, the neural structure
will not be in proximity to the retractor. In one embodiment, the
localization probe is manually operated by the surgeon performing
the surgery. This probe may or may not have a stimulus intensity
dial that enables the surgeon to control the level of stimulus
intensity delivered. This probe is rotated as it is inserted and a
stimulus is sent in a unidirectional manner. The stimulus produces
a signal that is conducted through a segment of nerve(s) or neural
structure and delivered to recording probe(s)/electrode(s) at the
nerve roots, the femoral nerve, and the muscles. These signals are
routed through an amplifier slave box(es), carried to the control
unit, calculations are made by the control unit using the depth at
which the stimulus was delivered, the level of stimulus delivered,
the angle/direction of stimulus, the location of the recording
probe(s)/electrode(s), the intensity of the signal captured by the
recording probe(s)/electrode(s), the elapsed time between stimulus
and signal recording, and the known anatomy of the neural
structures. Using these calculations, a three dimensional virtual
image can be simulated and displayed with accuracy in regard to the
proximity, direction, and depth from the skin of the nerve(s) or
neural structure(s) that traverse through or around the surgical
site.
[0013] In a further embodiment, the localization probe is the same
as the aforementioned, but also has a motorized rotation that is
synchronized with a repetitive stimulation as well as with the
signals received by the recording electrodes.
[0014] In a further embodiment, the localization probe is the same
as the aforementioned, but also has an automated depth gauge that
is synchronized with the previous information and calculations.
[0015] In a further embodiment, an arc introducer apparatus is
disclosed. The arc introducer apparatus includes: a rotating axis;
a radius arm connected to the rotating axis, wherein the radius arm
is configured to connect to an arc introducer needle; and wherein
the arc introducer apparatus is configured to be inserted over a
guidewire. The arc introducer apparatus can further include an arc
introducer needle at one end of the radius arm.
[0016] In a further embodiment, a method for placing a
neuromonitoring electrode within a tissue of a body includes
placing a guidewire within a body to reach a deep tissue; inserting
the radius introducer apparatus disclosed above over the guidewire
to approximately be flush to a surface of the body; adjusting a
radius arm of the radius introducer apparatus to a length
approximately equal to the depth of the guidewire inside the body;
pivoting the radius arm with the arc introducer needle to insert
the arc introducer needle to reach a neural structure to be
monitored; and inserting a flexible neuromonitoring electrode
through the arc introducer needle, and removing the arc introducer
needle to place the electrode at or close to the neural structure
to be monitored.
DESCRIPTION OF THE DRAWINGS
[0017] The foregoing aspects and many of the attendant advantages
of this invention will become more readily appreciated as the same
become better understood by reference to the following detailed
description, when taken in conjunction with the accompanying
drawings, wherein:
[0018] FIG. 1 is a flow diagram of one embodiment of a method for
monitoring nerve function during a surgical procedure;
[0019] FIG. 2 is a flow diagram of one embodiment of a method for
establishing a baseline function of nerves, including distal,
proximal, and across the site of the procedure;
[0020] FIG. 3 is a flow diagram of one embodiment of a method for
using a localization probe to determine the site for retractor
placement;
[0021] FIG. 4A is a flow diagram of one embodiment of a method for
monitoring nerve function during a surgical procedure;
[0022] FIG. 4B is a flow diagram of one embodiment of a method for
monitoring nerve function during a surgical procedure;
[0023] FIG. 5 is a flow diagram of one embodiment of a method for
locating an electrode within a region of the body;
[0024] FIG. 6 is a diagrammatical illustration of a system used to
monitor nerve function in accordance with one embodiment of the
invention;
[0025] FIG. 7 is an illustration of nerve location and electrode
placement to monitor nerve function in accordance with one
embodiment of the invention;
[0026] FIG. 8 is a diagrammatical illustration of a system for
localizing a nerve in accordance with one embodiment of the
invention;
[0027] FIG. 9 is an illustration showing the nerve location and
electrode placement for the procedure of localizing a nerve;
[0028] FIG. 10 is a diagrammatical illustration of an internal
electrode for use in monitoring nerve function;
[0029] FIG. 11 is a diagrammatical illustration of a rotating
electrode for sending a unidirectional signal;
[0030] FIG. 12 is a diagrammatical illustration of a cross section
of the electrode of FIG. 11 of the stimulator portion of a slave
box;
[0031] FIG. 13 is a diagrammatical schematic of a slave box with
switching capability between the differential amplifier circuit and
the stimulator circuit being switched to the stimulator
circuit;
[0032] FIG. 14 is a diagrammatical schematic of the slave box with
switching capability between the differential amplifier circuit and
the stimulator circuit being switched to the differential amplifier
circuit;
[0033] FIG. 15 is a diagrammatical schematic of two slave boxes
connected to a neuromonitoring machine and a patient for performing
a neurodiagnostic test from proximal to distal electrodes;
[0034] FIG. 16 is a diagrammatical schematic of two slave boxes
connected to a neuromonitoring machine and a patient for performing
a neurodiagnostic test from distal to proximal electrodes;
[0035] FIGS. 17A and 17B are diagrammatical illustrations of a
multipoint electrode and coupler; and
[0036] FIGS. 18A through 18H are diagrammatical illustrations of an
apparatus and steps for a method to introduce a nerve
probe/electrode to circumvent the posterior lateral fusion
mass.
DETAILED DESCRIPTION
[0037] Referring to FIG. 1, one embodiment for a method of
preparing for and monitoring nerve function during a surgical
procedure is illustrated. Although the description and the figures
may refer to a specific form of surgery, such as lateral access
spinal surgery, the methods disclosed herein can be used in other
types of surgery including, but not limited to, any minimally
invasive procedure or an open surgery involving the use of medical
instruments that in one way or another may apply traction or
compression forces on nerves. Furthermore, the methods disclosed
and claimed should not be construed as being limited to surgical
procedures, as the methods disclosed and claimed herein relate to
the monitoring of nerve function for other purposes. The methods
disclosed herein provide for greater sensitivity in monitoring the
nerve function during any surgical procedure, or otherwise, because
the aim of the methods is to provide monitoring of more than one
type of nerve fiber, including sensory and motor nerves and in more
than one conduction direction. The methods disclosed herein allow
for conducting monitoring of nerve function by testing the nerves
both in an orthodromic as well as antidromic manner. Finally, the
methods disclosed herein allow monitoring of nerve function by
stimulating nerves at locations that are proximal to the surgical
site and receiving the responses by nerves at locations distal to
the surgical site, and vice versa, thus effectively testing for
nerve signals across the surgical site in both directions.
[0038] Referring to FIG. 1, a method that includes preparing for
and conducting monitoring of nerve function is illustrated. Block
102 is for establishing a baseline function of the nerves to be
tested during the surgery. The method advantageously provides
greater sensitivity to loss of nerve function by testing various
types of nerve(s) fibers that are distal to the site of the
procedure, proximal to the site of the procedure, and course
across, through, or around the site of the procedure. The testing
also includes orthodromic and antidromic testing. Orthodromic as
used herein refers to testing an impulse propagating along an axon
in the normal direction. Antidromic is testing propagation opposite
to the ordinary direction that the nerve conducts. Block 102 is
described in greater detail in association with FIG. 2.
[0039] Once a baseline function of nerves is established, the
method moves to block 104. In block 104, a localization probe is
used to determine the site for placement of a retractor. Although a
retractor is disclosed herein as a medical instrument, the use of
which will be monitored for its affect on nerve function, the
methods and systems disclosed herein may be used to monitor other
medical instruments that can be employed in any number of different
surgical procedures, such as catheters, endoscopes, etc. Further,
step 104 may be optional if the surgical procedure does not call
for a retractor or similar instrument. When performed, the purpose
of block 104 is to determine the path for the placement of a
medical instrument, such as the retractor, to be used in the
surgical procedure. A localization probe, described in greater
detail below, is used to determine the location of any nerves to
avoid damaging these nerves when placing the retractor. Block 104
is described in greater detail in association with FIG. 3. After
completion of block 104, the method enters block 106. In block 106,
a surgical procedure can be performed. While nerve function
monitoring during surgery is one object disclosed herein, the nerve
conduction studies and the manner and order of conducting nerve
conduction studies may be used for purposes other than surgery. The
electrodes that are used in this block can be the same electrodes
that were used in block 102. Since the electrodes used in block 102
were used to establish a baseline function of nerves, in order to
determine whether the nerves undergo loss of function during
surgery, the same nerves can be tested during the surgical
procedure. The electrodes disclosed herein can have a dual purpose.
For example, one test may use an electrode for nerve stimulation.
The same electrode that is used for nerve stimulation in one test
can also be used to record the response of the nerve in a different
test, such as when testing calls for orthodromic and antidromic
testing, or when conducting proximal to distal locations, or vice
versa, regardless of whether the conduction is antidromic. Block
106 is described in greater detail in association with FIG. 4A.
[0040] Referring to FIG. 2 now, which corresponds to a more
detailed description of the block 102 of FIG. 1, a flow diagram for
establishing the nerve function baseline is illustrated. The
patient on whom the surgical procedure is to be performed is
positioned as in the actual surgery. Preferably, the patient will
be under general anesthesia. From the start block 200, the method
enters block 202. Block 202 is for placing the probes in tissues
within the patient. A probe, as used herein, is an electrical
conductor that may be used to both deliver an electrical signal
and/or receive an electrical signal. As such, the probe may also be
referred to as an electrode when performing in that capacity. A
suitable probe for this purpose is disclosed below. In one
embodiment, the probe locations for a lateral transpsoas approach
to the lumbar region of the spinal column are disclosed. However,
the nerves to be monitored for other surgical procedures will
become apparent to those skilled in the art from this disclosure. A
purpose of the methods disclosed herein are to locate probes at
locations that are proximal and distal to a surgical wound. In this
manner, the nerves that pass, course through, or are proximal to a
surgical wound and distal to a surgical wound can be monitored,
orthodromically and antidromically, and effectively across the
surgical wound. The disclosed method further provides for
monitoring various types of nerve fibers, such as sensory nerves
and motor nerves. The disclosed method advantageously provides
greater sensitivity to better inform the physician of potential
nerve damage.
[0041] One embodiment for monitoring nerve function for a lateral
transpsoas approach to the lumbar region of the spinal column
includes locating probes at one or any combination of nerve roots.
For the lateral transpsoas approach surgery, the L2, L3, and L4
nerves are considered to be proximal nerves. Proximal, as used
herein, refers to one of two positions that is the nearest to the
spinal cord or brain as compared to another or other positions.
Distal, as used herein, refers to a position that is further on the
nerve path as compared to the proximal position. The nerve root as
used herein is that portion of the nerve that exits the
neuroforamen. The probes can be placed close to the nerve root or
nerve and are placed with the aid of fluoroscopic localization as
described in greater detail below. For purposes of describing an
exemplary lateral transpsoas approach, the probes that are located
at one or a combination of the L2, L3, and L4 nerve roots are
proximal to the surgical site. A electrode/probe is also placed at
the femoral nerve that is distal to the surgical site. Finally,
electrodes/probes are placed at the L2, L3, and L4 myotomes and
dermatomes that are also distal to the surgical site. Myotomes and
dermatomes that correspond to the L2, L3, and L4 nerve roots are
apparent to those of skill in the art. Areas of the body
corresponding to the L2, L3, and L4 myotomes and dermatomes are
well known from the literature. While specific nerves are disclosed
herein as being monitored during lateral transpsoas spinal access
surgery, any nerves and nerve roots in the body could be accessed
using the disclosed probe. It is apparent that different surgical
locations would call for placement of probes at different
locations. Monitoring the nerve roots L2, L3, and L4 are merely
representative of a procedure that includes traversing the psoas
muscle. In other surgical procedures, other nerve roots may be
selected. In this particular description, the L2, L3, and L4 nerve
roots are chosen because they combine to form the femoral nerve in
proximity to the psoas muscle in the lumbar spine. Therefore, these
specific nerve roots and femoral nerve are consistently in jeopardy
during a direct lateral transpsoas surgical approach. Monitoring
sensory and motor nerves, proximal and distal, and across the
surgical site can be applied to any nerve roots or nerves
throughout the nervous system for providing greater sensitivity to
loss of nerve function.
[0042] A procedure of the insertion of probes into the tissues to
reach or be in proximity to monitor the various nerves will now be
described in more detail in association with FIG. 5. This procedure
can be used to introduce probes into nerves that course deep. The
method of introducing probes into tissues is similar to the
well-known Seldinger Technique. The Seldinger Technique is used for
insertion of catheters to various hollow organs or blood vessels.
However, to date, a Seldinger-like technique is not known for
insertion of electrode probes for conducting nerve monitoring.
Turning to FIG. 5, in block 502 a hollow introducer needle is
advanced in the tissue. The introducer needle is a well known
medical instrument. One embodiment of an introducer needle, for
example, may be variable gauge and variable length. From block 502,
the method enters block 504. In block 504, the method involves the
use of fluoroscopy to enable the physician to visualize and be able
to guide the introducer needle through the soft tissue to reach the
nerve of interest. Alternatively, CAT scan, ultrasonic, or other
suitable imaging technology may be used. From block 504, the method
enters block 506. In block 506, once the introducer needle has
reached the desired location, the physician advances the probe
within the introducer needle to reach the desired depth. From block
506, the method enters block 508. In block 508, the physician
removes the introducer needle to leave the electrode in place at
one of the nerve root sites mentioned above, or otherwise at any
other nerve. Alternatively, in another embodiment for inserting a
probe, a radius trajectory apparatus could be used. FIGS. 18A to
18H show an apparatus and steps used in an alternative method for
introducing a nerve probe/electrode. In one embodiment of FIGS. 18A
through 18H, a radius introducer apparatus, as described herein,
can be used to circumvent the posterior lateral fusion mass 1802.
However, the disclosed apparatus and method can be used to
circumvent other nerves. This apparatus and method is useful for
avoiding certain neural structures during probe placement by use of
a flexible probe. Avoiding certain neural structures is desirable
to reach a target nerve, which the probe is intended to monitor or
to provide a stimulus. FIG. 18A illustrates an introducer guidewire
1804 is placed from a direct posterior fluoroscopic approach to a
position, which is lateral to a posterior lateral fusion mass 1802
and inferior to the tip of the transverse process. The tip of the
guidewire 1804 is advanced in a lateral fluoroscopic view until the
tip is at the dorsal aspect of the neuroforamen. A radius
trajectory apparatus or radius introducer apparatus 1806 as
disclosed herein includes a radius arm 1808 that may be adjusted to
change the length. The radius arm 1808 is connected to a rotating
axis 1810 at one end of the radius arm 1808. The opposite end of
the radius arm 1808 is configured to hold an arc introducer needle
1812. The radius arm 1808 may be adjusted in length by telescoping
pieces or the connection to the rotating axis 1810, or the arc
introducer needle 1812 may be moved up or down on the radius arm to
change the length from the rotating axis 1810 to the arc introducer
needle 1812. An arc introducer needle 1812 is similar to an
introducer needle; however, the arc introducer needle 1812 is
shaped to provide a certain radius of curvature. This allows a
flexible probe to be placed from a direction other than a direct
linear approach. In one embodiment, the radius arm 1808 can be
rigid and essentially linear and the arc introducer needle 1812 is
rigid and has a radius of curvature. To attach the radius arm 1808
to the rotating axis 1810 or to the arc introducer needle 1812,
either the radius arm 1808, the rotating axis 1810 or the arc
introducer needle 1812 may have a clamping device. For example, the
end of the radius arm 1808 can be inserted within a socket or a
collar of the rotating axis 1810 composed of two halves, which can
then be tightened around the radius arm 1808 to hold the radius arm
through friction. To attach the arc introducer needle 1812 to the
radius arm 1808, the clamp may be on the end of the radius arm 1808
and the arc introducer needle 1812 slides within two halves of the
clamp, which is then tightened around the arc introducer needle
1812. The radius introducer apparatus 1806 is inserted over the
guidewire 1804 at the rotating axis 1810 until flush with the skin
as seen in FIG. 18B. The introducer guidewire 1804 has markings to
indicate depth. The depth marker at the skin is noted and the
radius arm 1808 is adjusted to the same length as also seen in FIG.
18B. FIGS. 18C and 18D illustrate the arc needle introducer 1812 is
then pivoted in an arc as dictated by the length of the radius arm
1808 and inserted in the body until the tip is at the end of the
guidewire 1804. In FIGS. 18E to 18H, the flexible probe/electrode
1814 is being introduced through the arc introducer needle 1812,
requiring that the stylet or needle 1812 be removed so that the
probe/electrode 1814 is placed through the arc introducer needle
1812 until the tip of the probe/electrode 1814 can be seen
protruding medial to the lateral border of the fusion mass 1802, as
seen in FIG. 18G. FIG. 18H shows the arc introducer needle 1812
being removed leaving the probe/electrode 1814 adjacent to the
nerve to be monitored/stimulated. This method is made possible with
the use of the probe disclosed herein, which is flexible and can be
inserted through a curved introducer needle 1812.
[0043] Once the introducer needle is removed, the probe can be
fixed to the patient, for example, with surgical tape and/or
bending the probe to allowing the probe to lie close to the skin of
the patient before taping to the skin. For that purpose, disclosed
herein is a bendable, flexible probe. Probes can be placed at L2,
L3, L4 nerve roots and the femoral nerve as disclosed above.
Procedures for the placement of probes and the types of probes used
at the myotomes and dermatomes are apparent to those of skill in
the art and will not be described herein for brevity.
[0044] Returning to FIG. 2, once the probes are located at the L2,
L3, and L4 nerve roots, the femoral nerve, and the selected
myotomes and dermatomes, the method enters from block 202 into one
or more blocks selected from 204, 206, 208, 210, 212, 214, and 216,
simultaneously, in series, or randomly. Blocks 204 through 216 are
representative of various nerve function monitoring schemes. It is
to be understood that other monitoring schemes can be used, the
ones described herein being merely exemplary. The disclosed method
uses a number of electrodiagnostic modalities that can be used
individually or in any combination in order simultaneously or
randomly to assess neurologic integrity across a segment of nerve
or nerves, prior to and during a surgical procedure. Furthermore,
this method describes the testing of sensory, motor, and mixed
fiber nerves in an orthodromic and antidromic fashion as well as
triggered electromyography as a means of evaluating nerve integrity
and performance. At least one nerve conduction study or EMG in a
direction from proximal to distal and one nerve conduction study
from distal to proximal are performed. The nerve function
monitoring schemes will now be described.
[0045] Block 204 provides a method of measuring and/or graphing an
orthodromic sensory nerve conduction study with a stimulus distal
at the femoral nerve, conducting to proximal at the nerve root
probe/electrode recording site. This step produces a "baseline"
performance for this anatomic section of the sensory nerve fibers
for the patient. This nerve conduction study is then repeated in
later steps, when during the actual surgery, a surgical retractor
is in use at a location between the stimulus site and the recording
site, in order to identify damage to the nerve fibers as
compression, traction, or vascular compromise occurs.
[0046] Block 206 provides a method of measuring and/or graphing a
mixed (sensory and motor) nerve conduction study with a stimulus
provided proximal at a nerve root probe, one probe at a time,
conducting to distal at the femoral nerve recording site. This step
produces a "baseline" performance for this anatomic section of the
sensory and motor nerve fibers for the patient. This will produce a
distinct unique waveform for each nerve root stimulated. These
nerve conduction studies are then repeated in later steps when,
during the actual surgery, a surgical retractor is in use at a
location between the stimulus site and the recording site in order
to identify damage to the nerve fibers as compression, traction, or
vascular compromise occurs.
[0047] Block 208 provides a method of measuring and/or graphing an
orthodromic sensory nerve conduction study with a stimulus distal
at the dermatome locations, conducting to proximal at the nerve
root probe recording site. This step produces a "baseline"
performance for this anatomic section of the sensory nerve fibers
for the patient. This nerve conduction study is then repeated in
later steps when, during the actual surgery, a surgical retractor
is in use at a location between the stimulus site and the recording
site in order to identify damage to the nerve fibers as
compression, traction, or vascular compromise occurs.
[0048] Block 210 provides a method of measuring and/or graphing an
antidromic sensory nerve conduction study with a stimulus provided
proximal at the nerve root probe/electrode, one probe at a time,
conducting to distal at the dermatome recording site. This step
produces a "baseline" performance for this anatomic section of the
sensory nerve fibers for the patient. This will produce a distinct
unique waveform for each nerve root stimulated. These nerve
conduction studies are then repeated in later steps, when, during
the actual surgery, a surgical retractor is in use at a location
between the stimulus site and the recording site in order to
identify damage to the nerve fibers as compression, traction, or
vascular compromise occurs.
[0049] Blocks 212-214 provide a method of measuring and/or graphing
a triggered electromyographic response to a stimulus provided
proximal at the nerve root probe, one probe at a time, conducting
to distal at the myotome recording site that corresponds to the
aforementioned nerve root, surface electrode, or needle electrode.
This step produces a "baseline" performance for this anatomic
section of the motor nerve fibers as well as the neuromuscular
junction for the patient. This will produce a distinct unique
waveform generated from the myotomes that correspond to each nerve
root stimulated. These triggered electromyographic studies are then
repeated in later steps when, during the actual surgery, a surgical
retractor is in use at a location between the stimulus site and the
recording site in order to identify damage to the nerve fibers as
compression, traction, or vascular compromise occurs. In a
situation where anesthetics negatively impact the neuromuscular
junction, electromyographic testing, such as the one described in
Blocks 212-216, may be unreliable. The disclosed method of testing
overcomes this drawback by performing a variety of tests on more
than one nerve.
[0050] Blocks 204-216 provide examples of electrodiagnostic testing
for a segment of nerve or nerves. In each instance, a circuit is
formed beginning with stimulus provided by a neuromonitoring
machine that is sent a stimulator/amplifier box (slave box). The
stimulator/amplifier box is connected to a stimulus probe, which
applies the stimulus to a segment of the patient's nerve tissue or
combination of nerve tissue and muscle tissue. The nerve reacts to
the stimulus which is recorded at a remote nerve with a recording
electrode. The signal received by the recording electrode is
amplified by an amplifier circuit in the stimulator/amplifier box,
processed by an analog to digital converter, and then sent back to
the neuromonitoring machine, which can process the digital
information into a waveform.
[0051] The electrical stimulus is generated at the neuromonitoring
machine, with the intensity being controlled, such as by a
technician under the instruction of a supervising physician. This
stimulus is applied to one location in the patient's body through a
stimulation probe, the electrical impulse that is generated is
transmitted along the nerve fibers by depolarization in a specific
direction towards a recording electrode, which receives the
electrical impulse. The electrical impulse is then carried to an
amplification circuit in the stimulator/amplifier box, which also
filters out other background electrical signals and noise, by using
a reference electrode. The remaining signal is then carried to the
neuromonitoring machine where it is processed through an analog to
digital converter to produce digital information that is converted
into a waveform. The stimulus may be generated once or numerous
times in order to generate a consistent reproducible waveform.
Nerve sensory studies can oftentimes require hundreds of
stimulations producing a single waveform for each stimulus. The
neuromonitoring computer then averages the responses in order to
produce a single waveform that is representative of those specific
nerve fibers.
[0052] In block 218, for each electrodiagnostic modality, the
stimulus intensity at which a consistent response at the recording
electrode is generated is measured and documented and saved in
memory, such as in the neuromonitoring machine. The waveform that
is subsequently formed is also documented in a graph form as well
as in terms of latency to onset or peak/trough and amplitude.
[0053] The information obtained by performing these
electrodiagnostic studies in blocks 204-216 prior to any invasive
surgical procedure produces a representative "baseline" neural
function for the patient. Such baseline information can be stored
in a memory of a neuromonitoring machine or other memory in one or
more computing devices for future comparison.
[0054] In block 220, a baseline waveform can be created from the
data for each testing scheme. The baseline waveform can be
established with the patient under anesthesia, in a relaxed
position (static state), with no limb manipulation (leg
flexion/extension etc.) or surgical instrumentation in place other
than for the probes. For each electrodiagnostic study performed, a
stimulus is initiated at the control unit that is then sent to a
stimulator/amplifier slave box, then through a probe/electrode to a
specific point of the nerve(s) or neural structure in the patient.
The signal is then carried along a section of the neural structure
to the location of a recording probe(s)/electrode(s). The signal is
then carried to a stimulator/amplifier slave box that also
incorporates a reference electrode to decrease background
electrical interference, "noise," and then the signal is carried
back to the control unit where it is converted from an analog
signal to a digital signal using an analog digital converter. The
digital information is then plotted in a waveform, and the
relationship between stimulus intensity and resultant waveform is
identified using time to signal strength response and intensity of
stimulus to size (amplitude) of signal response. A representative
neuromonitoring machine capable of being used in the disclosed
methods is the CASCADE system, provided by Cadwell Laboratories,
Inc., of Kennewick, Wash., USA.
[0055] The baseline waveform creation routine ends in block 222.
From block 222, the method returns to block 102 of FIG. 1 and
enters the subroutine of block 104, which is described in more
detail in association with FIG. 3.
[0056] Referring to FIG. 3, a flow diagram for localizing a nerve
in a muscle tissue is illustrated. As used herein, "localizing" is
intended to refer to a procedure for determining the location of
any neural structure in proximity to a surgical would, such that
once knowing its location, a medical instrument can be used safely
and in a manner that can avoid touching or being in close proximity
so as to avoid risk of injury to the nerve. For example, in lateral
spinal surgery, an incision for inserting a retractor is made in
the psoas muscle to gain access to a spinal column vertebra. In the
case of performing a transpsoas approach, it is desirable to locate
the lumbar plexus to allow for the safe introduction of a
retractor. Nerves that can be identified during the plexus
localization procedure include the genitofemoral nerve (L1, L2
roots) and lateral femoral cutaneous nerve (L2 L4), since these are
in jeopardy during the transpsoas approach. It is to be understood
that the localization of the lumbar plexus is specific to a
transpsoas procedure. However, the invention is not thereby
limited. In the case when a different surgical procedure is being
performed, it would be apparent to those skilled in the art the
nerve(s) or neural structures in proximity to the operative site
that would need to be localized.
[0057] The method for localization of a nerve or neural structure
begins in block 300. From block 300, the method enters block 302.
Block 302 is to signify that the probes and/or electrodes at the
nerve roots L2, L3, and L4, the femoral nerve, myotomes, and
dermatomes are in place from the baseline waveform determination
procedure discussed above in connection with FIG. 2. From block
302, the method enters block 304. In block 304, a localization
probe is advanced in the psoas muscle. The localization probe is
able to provide a unidirectional stimulus signal. A unidirectional
signal is a signal that generally only travels in one direction,
such that the signal is not spread across more than several degrees
of a 360 degree arc. Accordingly, the localization probe can be
rotated such that the potential area to be stimulated includes all
360 degrees of rotation. For such purpose, a localization probe
that provides a unidirectional signal will be described in more
detail below. The probe can further be rotated through 360 degrees
to provide a signal in any direction. The probe is provided with a
means for determining the direction of the unidirectional signal by
reference to a constant reference point that allows the angle of
rotation to be known when a signal is produced. The probe also has
a depth gauge that is either manual or automated. The depth gauge
provides a depth measurement at the time of unidirectional signal
production. Thus, both the direction and the depth of the
unidirectional signal can be determined. The probe rotation can
also be under control of a neuromonitoring machine, described in
more detail below. Thus, when a signal is applied using the
localization probe, the depth and direction are known for any
stimulus signal. This provides the ability to be able to map neural
structures in three dimensions.
[0058] From block 304, the method can enter one or both blocks 306
and 308. Block 306 is used to measure and/or graph the nerve
function response, if any, at the nerve roots L2, L3, and L4 after
a stimulus is generated from the localization probe. Block 308 is
used to measure and/or graph the nerve function response, if any,
at the myotomes after a stimulus is generated from the localization
probe. The neuromonitoring machine used to record, measure, and
process the response signal can be the same as the neuromonitoring
machine disclosed in connection with FIG. 2.
[0059] From blocks 306 and 308, the method enters block 310. In
block 310, a determination is made as to whether any waveforms are
present from the responses recorded at the L2, L3, L4, and myotome
electrodes. If the determination is NO, the method enters block
314, signifying that the nerve is not in the direction of the
stimulus signal. If the determination is YES, a second
determination is made as to whether the waveforms that are present
are a low or a high level stimulation. Any waveform generally
indicates that the lumbar plexus nerve is in the direction of the
stimulus signal. Depending on whether a low or a high level
waveform is detected can indicate the proximity of the nerve to the
probe. Further, because various types of nerves are being tested,
some types of nerve fibers will be stimulated, while others are
not. All the waveforms with corresponding values for stimulus
intensity, amplitude, latency, depth and any difference from the
baseline waveform can be displayed on a terminal. The physician can
view the display that conveys a virtual image of the nerve(s) or
neural structures in relation to the localization probe as well as
the depth at which the nerve(s) or neural structures were
encountered. This allows a surgeon to decide whether to advance the
localization probe further or rotate the probe in order to find a
way through the psoas muscle without hitting the lumbar plexus
nerve. During this portion of the procedure, the surgeon is
performing sensory and motor nerve conduction studies and triggered
electromyograph responses.
[0060] The method disclosed in FIG. 3 is a tool to enable the
physician to navigate a path through the psoas muscle in which a
medical instrument, such as a retractor, will be inserted. The
method disclosed in FIG. 3 is useful to locate a nerve(s) or neural
structure such as the lumbar plexus so as not to damage any neural
tissue when the retractor is advanced and subsequently
expanded.
[0061] After completion of the subroutine of FIG. 3, the system is
ready to proceed to the surgical procedure. From block 104, the
method enters block 106 of FIG. 1. Block 106 is the subroutine
performed during a surgical procedure after the preparatory
subroutines of blocks 102 and 104 have been completed. Block 106 is
described in more detail in association with FIG. 4A.
[0062] Referring to FIG. 4A, a method is disclosed for conducting a
surgical procedure while monitoring nerve function. The surgical
method is one that involves the use of a medical instrument that
applies traction and/or compression, for example, that may result
in damage of the nerves. However, the invention is not thereby
limited, as the system disclosed herein can be used to monitor
nerves under conditions not requiring of surgery. In situations
when surgery is being performed, it is desirable to monitor such
functioning of nerves to understand when an injury may be occurring
and then perform a corrective action to avoid permanent injury to
the nerves in the area of the surgery. According to the disclosed
method, nerves that are proximal to the surgical site and distal to
the surgical site are monitored to effectively test across the
surgical site to provide a more sensitive method for determining
the onset of any loss of nerve function at or in proximity to the
surgical site, such as where a retractor may be placed. In addition
to testing effectively across the surgical site in a proximal to
distal and distal to proximal fashion, the method also employs
testing various types of nerve fibers as well as testing the nerves
in an orthodromic and antidromic manner. While FIG. 4A shows the
nerves being monitored include the L2, L3, and L4 nerve roots, the
method disclosed herein is not thereby limited. In FIG. 4B, for
example, a method is disclosed for conducting a surgical procedure
while monitoring nerve function that can include any one of the C1
to S5 nerve roots, all roots, trunks, divisions, cords, or branches
of the brachial and lumbosacral plexus, and genitofemoral, lateral
femoral cutaneous, femoral, and obturator nerves.
[0063] The method begins at block 400. From block 400, the method
enters block 402. Block 402 is to designate that the probes at the
nerve roots L2, L3, L4, the femoral nerve, the probes at the
myotomes, and the probes at the dermatomes are in place from the
subroutine described in association with FIG. 2. From block 402,
the method enters block 404. In block 404, a medical instrument,
such as a retractor, is either advanced, expanded, or held in place
in the incision that was made in the subroutine described in
association with FIG. 3, the localization procedure. The disclosed
method provides an indication to the physician whether, at any time
during the use of the retractor, the onset of the loss of nerve
function may be imminent. Nerve function may diminish when tissues
are placed under traction or compression. Furthermore, loss of
nerve function can also be time dependent. Accordingly, throughout
the surgical procedure, the disclosed method continuously tests the
various types of nerve fibers in different directions to provide
the physician with more sensitive information regarding the loss of
any nerve function. The sensory conduction study will typically
show failure of the nerves first. The mixed conduction study will
typically next show a failure of the nerves. The triggered EMG
studies will typically show loss of nerve function last.
[0064] The retractor can be placed in the incision that was made
earlier using the localization probe. As the physician advances
and/or expands the retractor, or even when the retractor is held in
place, stimulus signals are provided by a series of probes at
various nerve locations and measured at other various nerve
locations that are distal or proximal to the stimulus location. In
essence, the signals are made to traverse across the surgical wound
from the stimulation location to the response location. In this
manner, the nerve function during surgery can be compared to the
earlier baseline nerve function data collected when no surgical
wound was present. The blocks 406-418 describe representative
studies that may be performed to monitor the nerve function during
the surgical procedure. The nerve studies defined by these blocks
are the same ones that were earlier used to define the baseline
waveforms. In block 406, a stimulus is provided at the distal
femoral nerve and the response is measured and/or graphed at the
proximal nerve roots L2, L3, and L4. In block 408, a stimulus is
provided at the proximal nerve roots L2, L3, and L4, one at a time,
and the nerve function response is measured and/or graphed at the
distal femoral nerve. In block 410, a stimulus is provided at the
distal dermatomes, one at a time, and the nerve response is
measured and/or graphed at the proximal nerve roots L2, L3, and L4.
In block 412, a stimulus is provided, one at a time, at each of the
proximal nerve roots L2, L3, and L4 and the nerve function is
measured and/or graphed at the distal dermatomes. In block 414, a
stimulus is provided at the proximal nerve root L2 and the EMG
response is measured and/or graphed at the distal myotome. In block
416, a stimulus is provided at the proximal nerve root L3 and the
EMG response is measured and/or graphed at the distal myotome. In
block 418, a stimulus is provided at the proximal nerve root L4 and
the EMG response is measured and/or graphed at the distal myotome.
The timing of the stimulus, to what probe the stimulus is provided,
the voltage, amplitude, amperage, time delay, and duration of the
stimulus signal, as well as reading and comparing the response to
the baseline, can be under control of a neuromonitoring machine
that will be described in more detail below. For example, amplitude
and duration of the stimulus signal may increase in stepwise
increments.
[0065] Each time a stimulus is provided in one of blocks 406-418
and a nerve or EMG response is obtained, the response is compared
to the baseline waveform obtained from the method disclosed in FIG.
2. It is possible that a comparison of the nerve function response
waveform to the baseline waveform will show one of four
possibilities: (1) no change, (2) increased latency, (3) decreased
amplitude, or (4) complete loss of the waveform. If no change is
noticed, it means that the nerve is functioning properly, i.e., no
differently than the baseline. If any of the other conditions are
noticed, the system may provide a notification to the physician and
timestamps the graph. The degree of change recognized in the
various electrodiagnostic testing modes gives the surgeon an idea
of "real time" nerve performance and gives indication of early
nerve compromise. Examples of how a surgeon would utilize this
information are various and dependent on each surgeon. For example,
the following conditions may arise: (1) If the waveforms are
unchanged from baseline even after the retractor is in place and
expanded, then the surgeon can continue the procedure without
change; (2) If the sensory waveforms begin to reveal deterioration
once the retractor is placed and expanded, then the nerve(s) or
neural structures are already under a certain amount of
compression/traction and should be monitored closely for further
deterioration; (3) If further deterioration occurs, then the
retractor should be relaxed, reduced in size, and the procedure
should be paused until the nerve performance has returned to
baseline or within a reasonable limit from the baseline. Other
actions may be possible, and the ones mentioned above should not be
construed as the only possible actions to take. For example, the
stimulus strength may increase or decrease, or other actions may be
appropriate. Deterioration of the nerves will generally be realized
by increased latency, meaning the time following a stimulus to the
time a response is recorded increases, or by decreasing amplitude
of the response. The retractor can then be expanded again and the
surgery proceeds. It may be necessary to relax the retractor
numerous times during the surgical procedure in order to ensure
neural structure preservation. If the waveforms including sensory,
motor, mixed, and triggered electromyography exhibit immediate
deterioration to a point where there is no response to stimulus
once the retractor is placed, a drastic change in surgical approach
may be considered because the likelihood of significant neural
injury is imminent.
[0066] During retractor placement and expansion, variable degrees
of compression and traction will be placed on the various types of
nerves. The disclosed method selects to test different nerves that
can potentially show different rates of deterioration. The sensory
conduction studies are represented in blocks 406, 410, 412, the
mixed nerve conduction studies are represented in block 408, and
the triggered EMGs are represented in blocks 414, 416, 418. The
specific order (e.g., sensory>mixed>motor or
motor>mixed>sensory) in which nerve performance is negatively
affected by compression, traction, and/or vascular compromise can
vary.
[0067] By providing the physician with information concerning the
sensory, motor, and mixed nerves spanning across, around, or
through the surgical site from proximal to distal, or distal to
proximal, the physician will be able to assess whether any
potential damage is being done to the nerve(s) or nerve structures
and modify the surgical procedure, or approach as needed in order
to preserve neural integrity and function.
[0068] FIG. 4B is similar to the method disclose in FIG. 4A;
however, the nerves to be monitored include any nerves selected
from one or more of the C1 to S5 nerve roots, all roots, trunks,
divisions, cords, or branches of the brachial and lumbosacral
plexus, genitofemeral, lateral femoral cutaneous, femoral and
obturator nerves. All other steps of FIG. 4B are similar to the
steps of FIG. 4A.
[0069] Next, the hardware used in conducting the above-mentioned
studies will be described.
[0070] FIG. 6 is a diagrammatical illustration of a system for
carrying out nerve conduction and EMG studies as described in
association with FIGS. 2, 4A, and 4B.
[0071] The system includes the neuromonitoring machine 602. The
function of the neuromonitoring machine 602 is, among others, for
controlling the stimulus to each of the respective probes in a
predetermined schedule. For instance, the voltage, amperage,
frequency, and duration or pulse width of each stimulus can be
controlled with the neuromonitoring machine 602. A suitable
neuromonitoring machine that can be configured according to the
disclosure herein is commercially available under the designation
CASCADE manufactured by Cadwell Laboratories, Inc.
[0072] The suitable neuromonitoring machine 602 includes hardware
and software capable of being programmed in accordance with the
disclosed methods herein to generate an electrical stimulus,
receive and process electrical signals generated by muscle or nerve
tissues, and display in graphical form the response and compare the
response signal to a baseline signal. Comparison can be by
displaying both the baseline and current waveform simultaneously in
real time, overlapping one another, or in different screens or
sections of a screen. Further comparisons can be performed by the
use of mathematical algorithms that can give an indication of the
"closeness" of one waveform to another. The neuromonitoring machine
602 includes software and controls. For example, controls may be
hard or soft controls, such as switches or dials. The controls
allow the technician or physician to make various adjustments to
the stimulus signal, and provide choices as to the probe or probes
to use for the stimulus signal. Further, the controls can allow the
technician or physician to customize a display window that shows
the waveforms of the response signals. Additionally, well-known
controls, such as brightness and contrast, can also be implemented
in the neuromonitoring machine. Further, the communication between
technician or physician and the neuromonitoring machine may be, by
way of a graphical user interface or GUI, capable of communicating
information. In addition, the neuromonitoring machine includes any
additional accessories, software drivers and modules, and
electrical components to connect to a stimulator/amplifier (slave
box) and/or the various nerve and EMG or myotome or dermatome
probes and electrodes. These additional components not specifically
mentioned herein are apparent to those of skill in the art. The
controls on the neuromonitoring machine will allow the technician
or physician to control the stimulus intensity, the duration of the
stimulus, and the frequency. The software of the neuromonitoring
machine may allow the technician or physician to program the
sequence and/or the stepwise increments of advancing any one of
these variables. Further, the software may allow the technician or
physician to adjust the sensitivity of the receiver probes to
eliminate any interference or background noise.
[0073] The following nerve conduction and EMG studies are
representative when performing lateral transpsoas surgery and
should not be limited solely to the studies identified below. Nerve
conduction studies 1 through 4 may be combined with
electromyography studies 5 through 7.
[0074] 1. An orthodromic sensory conduction study by applying a
stimulus at the distal femoral nerve and measuring a response at
proximal L2, L3, or L4 nerve roots. (Block 406.)
[0075] 2. A mixed nerve conduction study by applying a stimulus to
each one of the proximal nerve roots L2, L3, and L4, one at a time,
and measuring a response at the distal femoral nerve. (Block
408.)
[0076] 3. An orthodromic sensory conduction study by applying a
stimulus to a distal dermatome and measuring the response at the
corresponding proximal nerve root L2, L3, or L4. (Block 410.)
[0077] 4. An antidromic sensory conduction study to provide a
stimulus at a proximal nerve root L2, L3, and L4, one at a time,
and measuring the response at the corresponding distal dermatome.
(Block 412.)
[0078] 5. Triggered electromyography (EMG) by providing a stimulus
at the proximal L2 nerve root and measuring the response at the
corresponding distal myotome. (Block 414.)
[0079] 6. Triggered electromyography (EMG) by providing a stimulus
at the proximal L3 nerve root and measuring the response at the
corresponding distal myotome. (Block 416.)
[0080] 7. Triggered electromyography (EMG) by providing a stimulus
at the proximal L4 nerve root and measuring the response at the
corresponding distal myotome. (Block 418.)
[0081] Both sensory and motor nerves can be monitored. Sensory and
motor signals are generated and recorded in a similar manner, but
stimulation and recording parameters may differ. A sensory
conduction study may be performed with a series of stimulations,
and then the responses are averaged. Averaging is performed when a
generated signal is small in amplitude and other electrical
signals, interference, or "background noise" is likely to dominate
the recording. Averaging allows the elimination of this "background
noise." A sensory nerve conduction study may have a stimulus
intensity of 10-100 milliamps (mA), a duration of 0.02-0.07
milliseconds (ms), and a frequency of 3-6 Hz. A compound sensory
nerve action potential recording, which may or may not be averaged,
is usually recorded with a sensitivity setting of 10-100 microvolts
(.mu.V) amplitude, and 10-100 milliseconds (ms) timebase, and
latency is measured to the peak of the waveform.
[0082] A motor nerve conduction study may have a low-frequency
filter set at 30 Hz and a high-frequency filter set at 1 kHz
settings, a stimulus intensity of 1-100 mA, a duration of 0.02-0.05
milliseconds, and a frequency of 1-5 Hz. A compound motor action
potential response is usually recorded with a sensitivity setting
of 10-20 millivolt (mV) amplitude, and 25-50 millisecond (ms)
timebase, and latency is measured to the onset of the waveform.
[0083] Free run electromyography sensitivity is set at 50-500
microvolt (.mu.V), low-frequency filter (LFF) 20-30 Hz,
high-frequency filter 10 kilohertz (kHz) with a sweep speed of
10-200 millisecond (ms) per division.
[0084] Triggered electromyography settings may use a stimulus
intensity of 0.1-3 milliamps (mA), a frequency of 1-3 Hz, a pulse
width of 0.2 millisecond (ms) duration, a time base of 25-50
millisecond (ms), and a sensitivity set at 50-100 mV. All of the
stimulus and recording parameters are variable for each individual
case. The timebase will be dependent on the length of the segment
of nerve being tested. The longer the segment of nerve being
tested, the longer a timebase is required in which to capture the
nerve or muscle response. Parameters may change for different
patients and/or different procedures. The neuromonitoring machine
602 may also have an algorithm that decides which probes will
receive a stimulus, based on feedback from the physician or the
measured response.
[0085] The system includes one or more stimulator/amplifier boxes
("slave" boxes) that are connected to each probe where a stimulus
will be provided and from which each response will be received. The
system may include a plurality of such boxes to serve one or a
group of probes in proximity to each other, or a single box to
which all probes attach. As depicted in FIG. 6, the
stimulator/amplifier boxes include 604, 614, 628, and 630. The
stimulator/amplifier boxes include circuits to both provide a
stimulus to the probe(s) and amplification circuits to amplify any
signal detected by the probe(s) before sending to the
neuromonitoring machine 602. In this regard, a probe can function
to deliver a stimulus to a nerve in one study, and the same probe
can be used to receive a response in another study. Furthermore,
the stimulator/amplifier boxes may include a switch that allows the
switching of the probe function from stimulus provider to response
receiver. In one embodiment, the system includes probes 706, 708,
and 710 for each of the nerve roots L2, L3, and L4, probe 712 for
the femoral nerve, and probes 624 and 626 for the myotomes and
dermatomes, respectively, corresponding to the L2, L3, and L4 nerve
roots. The system includes additional electrodes connected to each
stimulator/amplifier box to function as reference, ground, or
cathode electrodes. Such additional electrode can function as a
cathode when a probe is providing a stimulus or as a reference when
a probe is providing a response. For example, the system includes a
reference electrode 702 connected to the stimulator/amplifier box
614 to allow probes at L2, L3, and L4 nerve roots to function as
receiver probes. The reference electrode is used to detect other
non-vital electrical signals that may be conducting through or
around the patient. These non-vital signals are carried to the
amplifier box by the reference electrode and subtracted from the
signal obtained via the recording probe(s)/electrode(s), which
leaves the vital signal information intact to be sent back to the
neuromonitoring machine 602 and converted into a waveform.
Electrode 702 may function as a cathode when nerve root probes 706,
708, and 710 are functioning as simulation probes (anodes). Other
reference/cathode electrodes include, for example, electrode 716
connected to stimulator/amplifier box 630 that is also connected to
dermatome probes 626, and electrode 713 connected to
stimulator/amplifier box 604 that is also connected to femoral
nerve probe 712. A ground electrode 700 is connected to each of the
simulator/amplifier boxes. For example, ground electrode 700 is
connected to the stimulator/amplifier box 614 to allow probes at
L2, L3, and L4 nerve roots to function as receiver probes. The
ground electrode 612 is ideally an infinite source or sink for
charge, which can absorb an unlimited amount of current without
changing its potential. The system may include an interface
616.
[0086] The interface 616 may include displays to enable a
technician to view the response, such as a waveform, from each
receiver probe. The interface 616 may also have soft or hard
controls to make remote adjustments to the neuromonitoring machine
602. The system may include a screen 618. The screen 618 may be
used for displaying the localization of the lumbar plexus during
the subroutine described in association with FIG. 3. The system may
include a remote interface and/or display 620. The remote interface
and/or display may provide the ability for remote control of the
neuromonitoring machine 602. The remote interface 620 may also
provide the capability to view the response waveforms. The
neuromonitoring machine 602 communicates to and from the interface
display 616, the screen 618, and the remote interface and display
620. Furthermore, the neuromonitoring machine 602 communicates to
and from the one or more stimulator/amplifier boxes 604, 614, 628,
and 630. As depicted in FIG. 6, the stimulator/amplifier box 604
communicates with the femoral nerve probe/electrode 712 or
combination of electrodes that are either on the skin, or inserted
deep to the skin over the femoral nerve. When functioning to
provide a stimulus, the probe is considered an anode. Also
connected to the stimulator/amplifier box 604 is a cathode
electrode 713. When acting as anodes to provide electrical
stimulation, a cathode electrode is placed in proximity to the
probes.
[0087] FIG. 7 is a diagrammatical illustration of the location of
the various nerves and probe placement that are disclosed for use
in the nerve conduction studies specifically for the lateral
transpsoas approach. Dermatome and myotome locations are not shown
as these locations are apparent to those of skill in the art. The
femoral nerve electrode 714 is positioned on or in the femoral
nerve 704. Similarly, probes are placed at or in proximity to the
nerve roots L2, L3, and L4, respectively, at locations 706, 708,
and 710. The location of probes L2, L3, and L4 are proximal in
relation to the surgical site of a lateral transpsoas approach,
while the probe location 714 for the femoral nerve is distal. The
placement of the probes at the femoral nerve and the L2, L3, and L4
nerve roots may use a probe as disclosed herein that is unlike
probes that are currently in use. Probes are placed utilizing the
procedure as disclosed above in connection with FIG. 5. Dermatome
electrodes, depicted collectively as 626 in FIG. 6 are not shown in
FIG. 7. However, the dermatome locations corresponding to the L1,
L2, and L3 nerve roots are apparent to one skilled in the art. The
EMG electrodes depicted collectively as 624 in FIG. 6 are not shown
in FIG. 7. The muscles of the myotome locations include the psoas,
vastus medialis, and rectus femoris. Electrodes suitable for
dermatomes and myotomes in EMG studies are apparent to those
skilled in the art.
[0088] In the orthodromic sensory conduction study (block 406), the
distal femoral nerve probe 712, which is the anode to provide a
stimulus, corresponds to location 712 in FIG. 7, and the electrode
713 is being used as a cathode and corresponds to location 713 in
FIG. 7. Both probes connect to stimulator/amplifier box 604, shown
in FIG. 6. The stimulator/amplifier box 604 uses a stimulator
circuit, described in greater detail below, to send a stimulus
signal to the femoral nerve probe 712. The proximal receiver probes
for L2, L3, and L4 correspond to locations 706, 708, and 710 in
FIG. 7, which connect to stimulator/amplifier box 614. To measure
responses from receiver probes, a reference and ground electrode
are required. To that end, the electrode 702 corresponds to
location 702, and the electrode 700 corresponds to ground at
location 700. Both electrodes 702 and 700 are connected to
stimulator/amplifier box 614. The stimulator/amplifier box 614 uses
a differential amplifier circuit, described in greater detail
below, to determine the measured response from each of the nerve
root probes. The L2, L3, and L4 probes are located deep so that the
distal ends of the probe are in proximity to and/or touching the
L2, L3, and L4 nerve roots exiting the neuroforamen. The reference
electrode 702 is either on the skin or deep to the skin, and the
ground electrode 700 is located on the skin. Orthodromic sensory
conduction studies may result in waveforms capable of being shown
on the display 616. A representative display may show, for example,
various windows within one display. Orthodromic sensory conduction
studies may be depicted in one window of the display. Each window
showing waveforms may include tool bars or menus that allow the
user to select various features that affect the display. A second
window may display waveforms of free run electromyography, which
can give indications when a nerve is actively being manipulated.
Adjustments can be made to stimulus intensity, pulse width,
frequency, filters, stored versus current waveforms, timebase,
sensitivity, averaging. A third window may show user selectable
options for conducting the different studies, such that previously
performed studies or stored waveforms may be recalled and compared,
different testing montages can be recalled, and windows can be
manipulated and reduced in order for better visualization of the
waveforms.
[0089] A system for performing a mixed nerve conduction study
(block 408), for example, providing a stimulus to each one of the
nerve roots L2, L3, and L4 individually and measuring the response
at the femoral nerve, may use the same hardware as described above
in connection with FIG. 6 and, therefore, will not be described
again for brevity. However, in contrast to orthodromic sensory
conduction studies, the operation of mixed nerve conduction studies
requires providing a stimulus to each one of the nerve roots via
probes 706, 708, and 710 one at a time, followed by measuring the
response at the femoral nerve via the probe 712. Further, in this
study, the stimulator/amplifier box 604 uses the electrode 713 as a
reference electrode, and the stimulator/amplifier box 604 uses a
differential amplifier circuit to determine the response at the
femoral nerve electrode 712. The stimulator/amplifier box 614 uses
a stimulator circuit because the nerve root probes are providing a
stimulus. The electrode 702 now functions as the cathode electrode
to the L2, L3 and L4 probes acting as anodes. The graphical
displays on the interface 616 may instead display waveforms
produced by the mixed nerve conduction studies and would be labeled
accordingly. Similarly, controls and adjustments would be labeled
for the study that is presently being performed.
[0090] A system for carrying out orthodromic sensory conduction
studies (block 410), for example, from each one of the dermatomes,
one at a time, to the nerve roots may use the same hardware as
described in association with FIG. 6 and utilizes the dermatome
electrodes 626 as stimulator probes. Dermatome locations
corresponding to the L2, L3, and L4 nerve roots are well known to
those of skill in the art. For example, from "Atlas of Human
Anatomy," Frank H. Netter, M.D., Ciba-Geigy Corp., pub., plate 150,
1989. In this study, the stimulator/amplifier box 630 connected to
the dermatome electrodes 626 may have a plurality of connection
sites for each one of the dermatome probes. When operating as a
stimulator probe, the use of a cathode probe is required. To that
end, the stimulator/amplifier box 630 is also connected to
electrode 716, which in this study is a cathode electrode. FIG. 7
illustrates that the electrode 716 is placed at iliac crest or
other boney prominence of the pelvis. The nerve root probes 706,
708, and 710 function as receiver probes, and, therefore, the
electrode 702 functions as a reference electrode. The orthodromic
sensory study, dermatome to nerve root, tests the sensory fibers
from their terminal points at the skin to the nerve root. This
study has the potential to be the most sensitive study for
assessing early neural compression, traction, or vascular insult.
The graphical displays on the interface may instead display
waveforms produced by the orthodromic sensory conduction studies
and would be labeled accordingly. Similarly, controls and
adjustments would be labeled for the study that is presently being
performed.
[0091] A system for carrying out antidromic sensory conduction
studies (block 412), for example, providing a stimulus at a nerve
root and measuring the nerve response at the dermatomes may use the
same hardware as described in association with FIG. 6. However, in
contrast to the stimulus being provided at the dermatomes, the
stimulus is provided at the nerve roots L2, L3, and L4 one at a
time. This is considered antidromic because for sensory nerves,
such as dermatomes, the normal direction is to conduct from the
skin to the brain. This study tests in the opposite direction. The
stimulator/amplifier box 614 uses electrode 702 as a cathode
electrode when nerve root probes are anodes providing a stimulus.
The dermatome electrodes are active to receive a response, and
therefore, the electrode 716 functions as a reference electrode.
The graphical displays on the interface 616 may instead display
waveforms produced by the antidromic sensory conduction studies and
would be labeled accordingly. Similarly, controls and adjustments
would be labeled for the study that is presently being
performed.
[0092] A system for carrying out L2 nerve root triggered
electromyography (EMG) (block 414) may use the same hardware as
described in association with FIG. 6 and utilizes the EMG needle at
the myotome. Muscles, such as the Psoas, Quadriceps (which include
vastus medialis, vastus intermedias, vastus lateralis, rectus
femoris), and Adductor Group (which includes adductor brevis,
adductor magnus, adductor longus, gracilis, pectinus) corresponding
to the L2 nerve root, as well as any other muscles, may be used to
measure the response. The hardware provides a stimulus at the L2
nerve root, and the response is measured with the EMG needle. A
probe used as a reference can be located on a boney prominence
close to the EMG needle. The graphical displays on the interface
may instead display waveforms produced by electromyography and
would be labeled accordingly. Similarly, controls and adjustments
would be labeled for the study that is presently being
performed.
[0093] A system for carrying out L3 nerve root triggered
electromyography (EMG) (block 416) may use the same hardware as
described in association with FIG. 6 and utilizes the EMG needle at
the myotome Muscles, such as the Psoas, Quadriceps (which include
vastus medialis, vastus intermedias, vastus lateralis, rectus
femoris), and Adductor Group (which includes adductor brevis,
adductor magnus, adductor longus, gracilis, pectinus) corresponding
to the L3 nerve root, as well as any other muscles, may be used to
measure the response. The hardware provides a stimulus at the L3
nerve root, and the response is measured with the EMG needle. The
graphical displays on the interface may instead display waveforms
produced by electromyography and would be labeled accordingly.
Similarly, controls and adjustments would be labeled for the study
that is presently being performed.
[0094] A system for carrying out L4 nerve root triggered
electromyography (EMG) (block 418) may use the same hardware as
described in association with FIG. 6 and utilizes the EMG needle at
the myotome. Muscles, such as the Psoas, Quadriceps (which include
vastus medialis, vastus intermedias, vastus lateralis, rectus
femoris), and Adductor Group (which includes adductor brevis,
adductor magnus, adductor longus, gracilis, pectinus) corresponding
to the L4 nerve root, as well as any other muscles, may be used to
measure the response. The hardware provides a stimulus at the L4
nerve root, and the response is measured with the EMG needle. The
graphical displays on the interface may instead display waveforms
produced by electromyography and would be labeled accordingly.
Similarly, controls and adjustments would be labeled for the study
that is presently being performed.
[0095] As can now be fully understood, a feature of the
stimulator/amplifier boxes 604, 614, 628 and 630 is the capability
to function as both stimulator and amplifier, depending on whether
the study that is being performed is orthodromic or antidromic,
conducting proximal to distal, or conducting distal to proximal.
One electrode can function as both the reference and cathode
electrode depending on whether a second electrode at the nerve
location is being used to stimulate the nerve or to record a
response from the nerve. To that end also, the stimulator/amplifier
boxes 604, 614, 628 and 630 are provided with a stimulator circuit
and differential amplifier circuit with capability of switching
manually or automatically via control from the neuromonitoring
machine 602. This capability is described in more detail below.
[0096] FIG. 8 is a diagrammatical illustration of a system for
carrying out the lumbar plexus localization technique that is
described in association with FIG. 3. The system for this procedure
includes some of the hardware described in association with FIG. 6,
and, in addition, includes a localization probe 804 with a rotating
tip that is described further below in association with FIGS. 11
and 12. In the configuration depicted in FIG. 8, the probes 706,
708, and 710 of the L2, L3, and L4 nerve roots, the EMG needles
624, and the electrode 702 can all connect to a single
stimulator/amplifier box 810. The rotating localization probe 804
can connect to a stimulator/amplifier box 808. Simulator/amplifier
boxes 808 and 810 can connect to the neuromonitoring machine 602.
The stimulator/amplifier box 808 can send a stimulus signal to the
distal tip of the localization probe 804. An outer sheath of the
localization probe 804 can function as cathode, or, alternatively,
an electrode dedicated to this purpose can be provided. A
rotational angle sensor 806 keeps track of the distal tip position
to allow determination of the direction of the unidirectional
signal. The rotating probe 804 can provide a stimulus at a distal
tip in a unidirectional manner that is only a few degrees (out of a
total of 360) in width at the tip. When a unidirectional signal is
provided by the tip, and depending on the nerve structure that is
in the direction of the signal, the nerve can produce a response
that is measured by the probes located at the nerve roots L2, L3,
and L4, or the myotomes. The closer that the nerve structure is to
the rotating probe tip, the stronger the response will be. For
example, if the nerve is located on the opposite side of the probe
to the active section of the probe tip, the response may initially
be weak or unobtainable. The response would increase with every
rotational adjustment that brings the active tip of the probe
closer to the nerve. When the probe signal trajectory is directed
towards the nerve (i.e., the closest point the probe is in relation
to the nerve), the strongest response will be observed. As the
probe is then rotated away from the nerve, the response will
gradually diminish with each rotational adjustment. Rotation may
include rotating the entirety of the probe or only the active tip.
The localization probe 804 may include control means for allowing
the surgeon to adjust the stimulus intensity, pulse width, depth,
direction, and to rotate the probe manually or via a motorized
synchronized system that records and analyzes all the data
regarding stimulus and signal acquisition in order to generate a
three dimensional image of the neural structure in the surrounding
tissue. By keeping track of the probe rotation and depth of the
probe tip in relation to a reference point and distance from the
skin, the nerve or neural structure or structures that are to be
avoided can be mapped with greater accuracy as compared when no
reference point is used. These measurements can create a more
accurate virtual image where radiologic images and anatomic
measurements or markers are applied to the calculations of neural
structure localization. A display can produce an animated version
of the nerve, for example, showing in three dimension the location
of the rotating probe with respect to any nerve.
[0097] FIG. 9 is an illustration of the probe placement for the
system described in association with FIG. 8. The rotating
localization probe 804 is placed in the psoas muscle for lateral
spinal access surgery. However, as mentioned above, the methods
disclosed herein are not limited to any one particular surgery, the
use of the psoas muscle for lateral spinal access surgery is merely
mentioned as one representative example to illustrate the concepts
disclosed. Similarly as with the nerve conduction studies and
electromyography, the waveforms produced by the lumbar plexus
localization study may also be displayed. A representative display
may show, for example, simultaneously the responses at the L2, L3,
and L4 nerve roots and triggered electromyography responses in the
myotomes following a stimulus from the rotating probe 804. The
waveforms detected at the femoral nerve may also be shown. The
window showing the waveforms may include tool bars or menus that
allow the user to select various features that affect the display.
Adjustments can be made through the display through soft buttons to
increase or decrease stimulus intensity, pulse width, frequency,
filters, stored versus current waveforms, timebase, sensitivity,
and averaging.
[0098] FIG. 10 is a diagrammatical illustration of a
probe/electrode 1000 that can be used to access a nerve or neural
structure that is deep to the skin in accordance with one
embodiment of the present invention. This probe/electrode 1000 may
be used for a variety of locations, including any of the spinal
nerve roots L2, L3, L4, and femoral nerve or other neural structure
mentioned herein. The nerve root probe/electrode 1000 includes
insulated monofilament or braided electroconductive material that
can be variable in caliber and length. The probe is made from a
medical grade monofilament 1002 or braided wire coated with an
electrical insulator 1004 with one or more exposed active points at
the internal (distal) end 1006 and at the external (proximal) end
1008. In one embodiment, the probe is a 27 gauge, 8 inch medical
grade monofilament wire (stainless steel) with insulation and 2 mm
exposed ends. For this particular embodiment, an 18 gauge, 3.5 inch
introducer needle can be used to place the probe 1000 at the
desired location. In one embodiment, each active point can function
independently as a stimulator or receiver site, or as an anode or
cathode. The probe is of adequate caliber and resistance to neural
structures with minimal degradation of signal. The probe is
flexible and pliable, which allows the external portion of the
probe to lie flush to the skin. The tip is blunt to avoid piercing
a nerve, nerve sheath, thecal sack, or vascular structures. A
coupler connects the external (proximal) end 1008 of the probe 1000
to a lead from an stimulator/amplifier box.
[0099] Referring to FIG. 11, a stimulator probe 804 used in the
localization subroutine of FIG. 3 is illustrated. The probe 804
includes an upper proximal body 1108. The body 1108 is connected to
an exterior insulator or sheath 1102 that runs substantially the
length of the probe except for terminating before the distal end.
In one embodiment, the sheath may be conductive to function as a
cathode. Interior to and juxtaposed next to the sheath 1102 is an
insulator material 1104. The second insulator 1104 is configured to
rotate within the sheath 1102. To that end, the insulator 1104 may
be connected to a rotating wheel 1110 at a top end thereof. The
wheel 1110 may be mechanically rotated or by hand. A magnetic
switch or series of switches can be provided on the wheel 1110 that
electrically convey the degrees of rotation of the wheel to a fixed
reference point. Within the interior of the insulator 1104, an
electroconductive material 1106 is provided that also rotates
together with the insulator 1104. As seen in the cross sectional
illustration of the tip in FIG. 12, the electroconductive material
1106 is not insulated on a side thereof at the distal (interior)
tip of the probe 804 to leave a small exposed surface 1114 of the
electroconductive material 1106 on one side only. In this manner,
the stimulus signal can be sent only from the exposed surface 1114.
This produces a unidirectional signal of several degrees of arc.
The localization probe 804 is connected to a stimulator/amplifier
box 808, and a stimulus is sent through the probe 804 as it is
being inserted. The position indicator of the wheel 1110 is to
indicate the direction in which the exposed electroconductive metal
surface 1114 is directed. The direction may be represented
graphically on a screen of the display 618 (FIG. 6). In one
embodiment, the sheath can include incremental measurements to
indicate the depth of the tip. Alternatively, depth can be measured
through the use of sensors positioned along the length of the probe
804. In one embodiment, the rotating wheel 1110 of the probe is
motorized, while in another embodiment, the rotation is manually
controlled by the surgeon. The motor is connected to the wheel 1110
of the probe 804 so that as the motor rotates, the tip rotates at
the same or different speed as the motor. The position can be
reported in degrees such as from 0.degree. to 360.degree.. This
information is synchronized and correlated with the electrical
signals received by the nerve probes. This is particularly useful
to allow mapping the location of a nerve.
[0100] FIGS. 13 through 16 schematically illustrate one embodiment
of a stimulator/amplifier (slave box) apparatus 1200 for use in the
methods disclosed herein. The slave box 1200 can be the slave boxes
shown in the FIGURES as any one of elements 604, 614, 628, 630,
808, 810, and 811.
[0101] FIG. 13 is a diagrammatical schematic of a slave box 1200
including both the stimulator circuit 1204 and differential
amplifier circuit 1202. The stimulator circuit 1204 has contacts
1206, 1208 for two probes, the anode and cathode, respectively.
However, additional contacts can be added to allow using multiple
probes. The stimulator circuit 1204 includes a circuit path
connecting the anode 1206 and cathode 1208, wherein the anode 1206
receives the electric stimulus signal from the neuromonitoring
machine described above.
[0102] The differential amplifier circuit 1202 includes contacts
for three probes, active 1210, reference 1212, and ground 1214
probes. However, additional contacts can be added to have multiple
active probes. More than one active probe can use the same ground
and reference probes. The differential amplifier circuit 1202
measures the received signal at the active probe 1210, and measures
the signal at the reference probe 1212, after signal conditioning
and amplification, a differential signal is calculated and sent to
the neuromonitoring machine. The differential signal is calculated
from subtracting the signal measured using the reference probe from
the signal measured using the active probe. A ground probe 1220 is
connectable to the differential amplifier circuit 1202 of the slave
box 1200. A first 1216 and a second 1218 probe are connectable to
the switch 1226 on a first contact side thereof. The first probe
1216 can be an anode (stimulator) or active (receiver) probe,
depending on switch 1226 position. The second probe 1218 can be a
cathode or reference probe depending on switch 1226 position. The
opposite contact side of the switch 1226 has a pair of contacts
1222, 1224 that are selectable to connect with either the anode
1206 and cathode 1208 contacts of the stimulator circuit 1204 or to
the active 1210 and reference 1212 contacts of the differential
amplifier circuit 1202. In a first switch position as shown in FIG.
13, the switch contact 1222 is making contact at the anode 1206 of
the stimulator circuit 1204. The second switch contact 1224 is
making contact with the cathode 1208 of the stimulator circuit
1204. In this mode, the electrode 1216 is the anode, and the
electrode 1218 is the cathode.
[0103] Referring to FIG. 14, the switch 1226 is shown in a second
position. The pair of contacts 1222, 1224 on the switch 1226 are
now aligned to the active 1210 and reference 1212 contacts of the
differential amplifier circuit 1202. In this mode, the first
electrode 1216 is the active probe, and the second electrode 1218
is the reference probe.
[0104] Referring to FIG. 15, a diagrammatical schematic of the
slave box is shown for a representative proximal to distal nerve
conduction study or triggered EMG study.
[0105] In this configuration, the neuromonitoring machine 602 is
connected to a first 1200A and second 1200B slave box. The first
slave box 1200A is connected to three or more electrodes 1220A,
1216A, and 1218A on the patient 800 at a proximal location in
relation to a surgical site. The second slave box 1200B is
connected to three or more electrodes 1220B, 1216B, and 1218B on
the patient 800 at a distal location in relation to a surgical
site. One electrode out of the three for each slave box 1200A,
1200B is a ground electrode, which in this case are represented by
electrodes 1220A and 1220B. The two electrodes that are not the
ground electrode function as a pair, such as the active and
reference or the anode and cathode, depending on the switch
position of the slave box. For example, in conducting proximal to
distal, the first proximal slave box 1200A has the switch 1226A set
to connect the anode contact of the stimulator circuit 1204A to a
first proximal electrode 1216A and the cathode contact of the
stimulator circuit 1204A to the second proximal electrode 1218A. In
this mode, the first electrode 1216A is stimulating the nerve at a
location proximal to the surgical site. In the second distal slave
box 1200B, the switch 1226B is shown so that the active contact of
the differential amplifier circuit 1202B is connected to the first
distal probe 1216B and the reference contact of the differential
amplifier circuit 1202B is connected to the second distal electrode
1218B. The neuromonitoring machine 602 can then send a stimulus at
the proximal anode electrode 1216A and receive the response at the
distal active electrode 1216B, thus allowing proximal to distal
nerve conduction or EMG studies. FIG. 16 is provided to illustrate
conducting distal to proximal nerve conduction studies using the
same hardware as shown in FIG. 15 by operating the switches 1226A,
1226B on the respective first and second slave boxes 1200A, 1200B
to a second position. The first distal electrode 1216B of the
distal slave box 1200B can then be connected to the anode contact
of the stimulator circuit 1204B, and the second distal electrode
1218B is connected to the cathode contact of the stimulator circuit
1204B. The first proximal electrode 1216A of the proximal slave box
1200A can then be connected to the active contact of the
differential amplifier circuit 1202A, and the second proximal
electrode 1218A is connected to the reference contact of the
differential amplifier circuit 1202A. As can be seen, a proximal
electrode can be used in proximal to distal nerve conduction or EMG
studies as a proximal stimulator electrode, and the same proximal
electrode can be used as an active receiver electrode in distal to
proximal nerve conduction studies. Similarly, a distal electrode
can be used in distal to proximal nerve conduction studies as a
distal stimulator electrode, and the same distal electrode can be
used as an active receiver electrode in proximal to distal nerve
conduction studies. This advantageously allows for testing to be
conducted from proximal to distal and from distal to proximal by
the operation of a switch and without disconnecting and
reconnecting the probes. Furthermore, the switches 1226A, 1226B can
be hard wired switches or soft switches. In a hard wired switch,
the physician or other surgical team member may physically move the
position of the switch. Alternatively, the switches 1226A, 1226B
can be "soft" switches and are controlled by software running on
the neuromonitoring machine 602. Since the neuromonitoring machine
602 can select the nerve conduction study or EMG to execute, the
neuromonitoring machine 602 can select the switch position as part
of executing the nerve conduction study or EMG.
[0106] FIG. 17 is a diagrammatical illustration of a flexible,
multiple point electrode 1300 and a corresponding coupling 1302. To
render an electrode 1300 with multiple active points, the
insulation can be stripped in a circumferential manner from several
locations proximal to the distal tip end of the electrode 1300
shown as the active locations 1304, 1306, 1308, and 1310. For
example, a multistrand conductor having four independently
insulated wires can allow for four active points. Insulation can be
stripped at the internal or distal tip to create the multiple
active points 1304, 1306, 1308, and 1310 at the distal tip.
Stripping the insulation from each independently insulated wire at
a different location exposes the conductive material from the wire
at a different point to serve as one of multiple active points of
the probe. Similarly, corresponding points 1312, 1314, 1316, and
1318 at the external or proximal tip are created that allows
connection to an stimulator/amplifier box via the coupling 1302. A
representative coupling 1302 is illustrated alongside the electrode
1300. A female coupling 1302 having four independent connection
sites 1320, 1322, 1324, and 1326 are each connected to a separate
wire and then combined into an insulated multistrand conductor 1328
leaving the coupling 1302. The insulated multistrand conductor can
be coupled to any stimulator/amplifier box. Each of the points of
the external tip of the multipoint electrode are insulated from
each other at both the external tip and the internal tip. For
example, the probe can include multiple insulated wires wherein
each insulated wire is stripped without stripping the other wires
at the same location.
[0107] While illustrative embodiments have been illustrated and
described, it will be appreciated that various changes can be made
therein without departing from the spirit and scope of the
invention.
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