U.S. patent application number 13/105734 was filed with the patent office on 2011-12-08 for surgical navigational and neuromonitoring instrument.
This patent application is currently assigned to Warsaw Orthopedic, Inc.. Invention is credited to W. Keith Adcox, John B. Clayton, David Mire, Eric Ryterski, Robert Teichman, Laurent Verard.
Application Number | 20110301593 13/105734 |
Document ID | / |
Family ID | 39705026 |
Filed Date | 2011-12-08 |
United States Patent
Application |
20110301593 |
Kind Code |
A1 |
Teichman; Robert ; et
al. |
December 8, 2011 |
SURGICAL NAVIGATIONAL AND NEUROMONITORING INSTRUMENT
Abstract
The invention relates to a surgical instrument capable of
applying an electrostimulation to a neural structure. The surgical
instrument also has a tracking system associated therewith to
provide navigational tracking during a surgical procedure.
Inventors: |
Teichman; Robert;
(Lafayette, CO) ; Verard; Laurent; (Superior,
CO) ; Ryterski; Eric; (Louisville, CO) ;
Adcox; W. Keith; (Memphis, TN) ; Clayton; John
B.; (Superior, CO) ; Mire; David; (Cordova,
TN) |
Assignee: |
Warsaw Orthopedic, Inc.
Warsaw
IN
|
Family ID: |
39705026 |
Appl. No.: |
13/105734 |
Filed: |
May 11, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11626917 |
Jan 25, 2007 |
7987001 |
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13105734 |
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Current U.S.
Class: |
606/41 ;
607/116 |
Current CPC
Class: |
A61B 17/1655 20130101;
A61B 2034/105 20160201; A61B 2034/107 20160201; A61B 34/25
20160201; A61B 2017/00734 20130101; A61B 2034/256 20160201; A61B
34/20 20160201; A61B 2090/365 20160201; A61B 17/1671 20130101; A61N
1/0551 20130101; A61B 17/02 20130101; A61B 2017/00026 20130101;
A61B 2017/00039 20130101; A61B 6/506 20130101; A61B 17/8875
20130101; A61B 90/36 20160201; A61B 2034/2051 20160201 |
Class at
Publication: |
606/41 ;
607/116 |
International
Class: |
A61B 18/18 20060101
A61B018/18; A61N 1/00 20060101 A61N001/00 |
Claims
1.-36. (canceled)
37. A surgical tool capable of applying electrostimulation
comprising: an instrument having a handle portion and a body member
extending from the handle portion, the body member having an
electrically conductive portion connected to an energy source and
capable of applying electrostimulation energy provided by the
energy source; and a tracking system associated with the instrument
and operative to provide information regarding a position of the
instrument on a display, the tracking system being configured to
detect neurological information based on electrostimulation energy
applied by the instrument and superimpose the neurological
information on the instrument position on the display.
38. The surgical tool of claim 37 wherein the handle portion
includes an electrical lead connectable to the energy source,
wherein the energy source is remote from the instrument.
39. The surgical tool of claim 37 wherein the energy source
includes a battery pack disposed within the handle portion.
40. The surgical tool of claim 37 wherein the body member includes
an electrically insulated outer surface area, and wherein the
electrically conductive portion extends from the handle portion and
internal to the insulated outer surface.
41. The surgical tool of claim 37 wherein the tracking system
includes a set of reflectors connected to the instrument and
operative to reflect energy that can be detected and analyzed by a
navigation system to determine a real-time position of the
instrument.
42. The surgical tool of claim 41 wherein the set of reflectors are
connected to an outer surface of the handle portion.
43. The surgical tool of claim 37 wherein the tracking system
includes a set of emitters connected to the instrument and
operative to provide detectable energy that can be analyzed by a
navigational system to determine a real-time position of the
instrument.
44. The surgical tool of claim 43 wherein the set of emitters are
powered by electrical energy provided to the instrument by the
energy source.
45. The surgical tool of claim 37 wherein the instrument is capable
of applying bi-polar electrostimulation.
46. The surgical tool of claim 37 wherein the instrument is a
surgical probe.
47. The surgical tool of claim 37 wherein the instrument is a
surgical tap.
48. The surgical tool of claim 37 wherein the instrument is a
screwdriver.
49. The surgical tool of claim 37 wherein the instrument is a
retractor.
50. The surgical tool of claim 37 wherein the instrument is capable
of applying uni-polar electrostimulation.
51. A surgical tool assembly comprising: an instrument having a
handle, an insulating sheath, and a conductive member connected to
the handle and internal to the insulating sheath, wherein a portion
of the conductive member projects distally from the insulating
sheath; an energy source operable with the instrument and designed
to provide electrical energy to the conductive member for
application of electrostimulation to a neural structure when the
neural structure is in contact with the portion of the conductive
member and electrical energy is provided to the conductive member;
and a tracking system associated with the instrument and operative
to provide information regarding a position of the instrument on a
display, the tracking system being configured to detect
neurological information based on the electrostimulation energy
applied by the instrument and superimpose the neurological
information on the instrument position information on the
display.
52. The surgical tool assembly of claim 51 wherein the energy
source is a battery.
53. The surgical tool assembly of claim 52 wherein the battery is
housed within the handle.
54. The surgical tool assembly of claim 51 wherein the insulating
sheath includes a non-conductive coating on the conductive
member.
55. The surgical tool assembly of claim 51 wherein the instrument
is one of a probe, a retractor, a screwdriver, and a tap.
56. The surgical tool assembly of claim 51 wherein the instrument
is capable of applying bipolar or unipolar electrostimulation to
the neural structure.
57. The surgical tool assembly of claim 51 wherein the tracking
system includes active, passive, or a combination of active and
passive tracking elements.
58. A neuromonitoring system capable of applying electrostimuation
energy to a neural structure, the system comprising: an instrument
comprising: a handle and a stylet extending from a distal end of
the handle; and a navigational sensor associated with at least one
of the handle and the stylet, the navigation sensor operative to
provide feedback regarding a position of the instrument, and a
tracking system associated with the instrument and operative to
provide information regarding a position of the instrument on a
display, the tracking system being configured to detect
neurological information based on the electrostimulation energy
applied by the instrument and superimpose the neurological
information on the instrument position information on the
display.
59. The neuromonitoring probe of claim 58 further comprising a
cannula of insulating material extending from the distal end of the
handle and wherein the stylet is disposed within a lumen of the
cannula.
60. The neuromonitoring probe of claim 59 wherein the navigational
sensor is secured to an outer surface of the cannula.
61. The neuromonitoring probe of claim 60 wherein the navigational
sensor is a reflector.
62. The neuromonitoring probe of claim 58 wherein the handle houses
an energy source that provides energy to the stylet for the
application of electrostimulation to a neural structure.
63. The neuromonitoring probe of claim 63 wherein the energy source
is a battery.
64. The neuromonitoring probe of claim 58 wherein the stylet
includes a pointed distal end capable of forming a hole in a
pedicle.
Description
BACKGROUND
[0001] Surgical procedures and, in particular, neuro-related
procedures are often assisted by a surgical navigational system to
assist a surgeon in translating and positioning a surgical tool or
probe. Conventional surgical navigational systems use reflectors
and/or markers to provide positional information of the surgical
tool relative to a preoperative rendering of a patient anatomy.
Surgical navigational systems, however, do not carry out
neuromonitoring functions to determine the integrity of a neural
structure or the proximity of the surgical tool to that neural
structure. On the other hand, neural integrity monitoring systems
are designed to use electrostimulation to identify nerve location
for predicting and preventing neurological injury. However, neural
integrity monitoring systems do not provide visual navigational
assistance. Therefore, there is a need for an integrated
neuromonitoring and surgical navigational system that is capable of
visually assisting a surgeon in navigating a surgical tool or probe
as well as being capable of neuromonitoring to evaluate surgical
tool proximity to a neural structure and/or the integrity of the
neural structure. There is a further need to have surgical
instruments that can apply electrostimulation and be tracked for
surgical navigation.
SUMMARY
[0002] In one aspect, this disclosure is directed to an apparatus
having a surgical tool capable of applying electrostimulation. The
surgical tool includes an instrument having a handle portion and a
body member extending from the handle portion. The body member has
an electrically conductive portion connected to an energy source
and is capable of applying electrostimulation energy provided by
the energy source. The surgical tool further has a tracking system
associated with the instrument and operative to provide information
regarding a position of the instrument.
[0003] In accordance with another aspect of the present disclosure,
a surgical tool assembly is disclosed. The surgical tool assembly
includes an instrument having a handle, an insulating sheath, and a
conductive member connected to the handle and internal to the
insulating sheath. A portion of the conductive member projects
distally from the insulating sheath. The surgical tool assembly
further has an energy source operable with the instrument and
designed to provide electrical energy to the conductive member for
application of electrostimulation to a neural structure when the
neural structure is in contact with the portion of the conductive
member and electrical energy is provided to the conductive member.
The surgical tool assembly further has a tracking system associated
with the instrument and operative to provide information regarding
a position of the instrument.
[0004] According to another aspect, the present disclosure is
directed to a surgical method that includes inserting a surgical
instrument through tissue to a vertebral structure and tracking a
position of the surgical instrument relative to the vertebral
structure on a user interface. The method further includes
delivering an electrical stimulus to the vertebral structure using
the surgical instrument and monitoring neurological response to the
electrical stimulus.
[0005] In accordance with a further aspect, the present disclosure
includes a neuromonitoring instrument capable of applying
electrostimuation to a neural structure. The instrument has a
handle and a stylet extending from a distal end of the handle. The
instrument further has a navigational sensor associated with at
least one of the handle and the stylet. The navigation sensor is
operative to provide feedback regarding a position of the
instrument.
[0006] These and other aspects, forms, objects, features, and
benefits of the present invention will become apparent from the
following detailed drawings and descriptions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a pictorial view of an integrated surgical
navigational and neuromonitoring system.
[0008] FIG. 2 is a pictorial view of a surgical suite incorporating
the integrated surgical navigational and neuromonitoring system of
FIG. 1.
[0009] FIG. 3 is a block diagram of the integrated surgical
navigational and neuromonitoring system of FIG. 1.
[0010] FIG. 4 is a front view of a GUI displayed by the integrated
surgical navigational and neuromonitoring system of FIGS. 1-3.
[0011] FIG. 5 is a front view of a portion of the GUT shown in FIG.
4.
[0012] FIG. 6 is a block diagram of a wireless instrument tracking
system for use with the integrated surgical navigational and
neuromonitoring system of FIGS. 1-3.
[0013] FIG. 7 is a side view of surgical probe according to one
aspect of the present disclosure.
[0014] FIG. 8 is a side view of a cordless retractor capable of
applying electrostimulation according to one aspect of the present
disclosure.
[0015] FIG. 9 is a side view of a corded retractor capable of
applying electrostimulation according to one aspect of the present
disclosure.
[0016] FIG. 10 is a side view of a cordless bone screwdriver
capable of applying electrostimulation according to one aspect of
the present disclosure.
[0017] FIG. 11 is a side view of a surgical tap capable of applying
electrostimulation according to another aspect of the present
disclosure.
[0018] FIG. 12 is a side view of a surgical probe according to
another aspect of the present disclosure.
[0019] FIG. 13 is a cross-sectional view of the surgical probe of
FIG. 12 taken along lines 13-13 thereof.
[0020] FIG. 14 is an end view of the surgical probe shown in FIGS.
12-13.
[0021] FIG. 15 is a flow chart setting forth the steps signaling
instrument proximity to an anatomical structure according to one
aspect of the present disclosure.
[0022] FIG. 16 is a flow chart setting forth the steps of accessing
and publishing technical resources according to an aspect of the
present disclosure.
[0023] FIG. 17 is a flow chart setting forth the steps of
determining neural structure integrity according to one aspect of
the invention.
[0024] FIG. 18 is a neuromonitoring probe according to another
aspect of the invention.
DETAILED DESCRIPTION
[0025] The present disclosure relates generally to the field of
neuro-related surgery, and more particularly to systems,
instruments, and methods for integrated surgical navigation and
neuromonitoring. For the purposes of promoting an understanding of
the principles of the invention, reference will now be made to
embodiments or examples illustrated in the drawings, and specific
language will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of the invention is
thereby intended. Any alteration and further modifications in the
described embodiments, and any further applications of the
principles of the invention as described herein are contemplated as
would normally occur to one skilled in the art to which the
disclosure relates.
[0026] With reference to FIG. 1, there is shown an apparatus for
the symbiotic display of surgical navigational and neuromonitoring
information to assist a physician in diagnosing and treating
various neuro-related conditions. In this regard, a number of
surgical procedures can benefit from the present disclosure, such
as discectomies, spondy reductions, disc replacements, joint
replacements, scoliosis-related procedures, and many others. The
integrated image-based surgical navigation and neuromonitoring
system 10 enables a surgeon to generate and display on monitor 12
the trajectory of instrument 14, which is preferably a surgical
instrument also capable of facilitating the acquisition of
neurological information, relative to a visualization of patient
anatomy. Data representing one or more pre-acquired images 16 is
fed to computer 18. Computer 18 tracks the position of instrument
14 in real-time utilizing detector 20. Computer 18 then registers
and displays the trajectory of instrument 14 with images 16 in
real-time. An icon representing the trajectory of instrument 14 is
superimposed on the pre-acquired images 16 and shown on monitor 12.
At the surgeon's command, the real-time trajectory of instrument 14
can be stored in computer 18. This command also creates a new
static icon representing the trajectory of the instrument on
display 12 at the time the surgeon's command was issued. The
surgeon has the option of issuing additional commands, each one
storing a real-time trajectory and creating a new static icon for
display by default. The surgeon can override this default and
choose to not display any static icon. The surgeon also has the
option to perform a number of geometric measurements using the
real-time and stored instrument trajectories.
[0027] In addition to displaying and storing a trajectory of
instrument 14 relative to patient anatomy, computer system 18 also
updates the visualization of patient anatomy shown on display 12
with indicators representative of neurological information acquired
from the patient. As will be described in greater detail below, the
neurological indicators can include color coding of certain
anatomical structures, textual or graphical annotations
superimposed on the pre-acquired images or visualization thereof,
or other identifying markers. Reference to a visualization of
patient anatomy herein may include a pre-acquired image, a
graphical representation derived from one or more pre-acquired
images, atlas information, or a combination thereof.
[0028] Referring to FIG. 2, a surgical suite 22 incorporating the
image-based surgical navigation and neuromonitoring system 10 is
shown. Pre-acquired images of patient 24 are collected when a
patient, lying on table 26, is placed within C-arm imaging device
28. The term "pre-acquired," as used herein, does not imply any
specified time sequence. Preferably, however, the images are taken
at some time prior to when surgical navigation is performed.
Usually, images are taken from two substantially orthogonal
directions, such as anterior-posterior (A-P) and lateral, of the
anatomy of interest. The imaging device 28 includes x-ray source 30
and x-ray receiving section 32. Receiving section 32 includes
target tracking markers 34. Operation of the C-arm imaging device
28 is controlled by a physician or other user by C-arm control
computer 36.
[0029] While a C-arm imaging device 28 is shown for the acquisition
of images from patient 24, it is understood that other imaging
devices may be used to acquire anatomical and/or functional images
of the patient. For example, images may be acquired using computed
tomography (CT), magnetic resonance (MR), positron emission
tomography (PET), ultrasound, and single photon emission computed
tomography (SPECT). An O-arm imaging system may also be used for
image acquisition. Further, it is contemplated that images may be
acquired preoperatively with one type of imaging modality remote
from the surgical suite 22 and acquired preoperatively or
intraoperatively at the surgical suite 22 with another type of
imaging modality. These multi-modality images can be registered
using known registration techniques.
[0030] Acquired images are transmitted to computer 36 where they
may be forwarded to surgical navigation computer 18. Computer 18
provides the ability to display the received images via monitor 12.
Other devices, for example, such as heads up displays, may also be
used to display the images.
[0031] Further referring to FIG. 2, system 10 generally performs
the real-time tracking of instrument 14, and may also track the
position of receiver section 32 and reference frame 38. Detector 20
senses the presence of tracking markers on each object to be
tracked. Detector 20 is coupled to computer 18 which is programmed
with software modules that analyze the signals transmitted by
detector 20 to determine the position of each object in detector
space. The manner in which the detector localizes the object is
known in the art.
[0032] In general, instrument 14 is tracked by the detector, which
is part of an optical tracking system (not shown) using attached
tracking markers 40, such as reflectors, in order for its
three-dimensional position to be determined in detector space.
Computer 18 is communicatively linked with the optical tracking
system and integrates this information with the pre-acquired images
of patient 24 to produce a display which assists surgeon 42 when
performing surgical procedures. An iconic representation of the
trajectory of instrument 14 is simultaneously overlaid on the
pre-acquired images of patient 24 and displayed on monitor 12. In
this manner, surgeon 42 is able to see the trajectory of the
instrument relative to the patient's anatomy in real-time.
[0033] Further referring to FIG. 2, the system according to the
invention preferably has the ability to save the dynamic real-time
trajectory of instrument 14. By issuing a command using foot-switch
44, for example, computer 18 receives a signal to store the
real-time trajectory of the instrument in the memory of computer
18. Alternately, the surgeon or other user may issue the command
using other input devices, such as a push-button on the instrument,
voice command, touchpad/touch screen input, and the like. This
"storage command" also instructs computer 18 to generate a new
static icon representing the saved trajectory of the instrument,
essentially "freezing" the icon at the point when the input was
received. The static icon, along with the icon representing the
real-time trajectory of the instrument, can be simultaneously
superimposed over the pre-acquired image. If multiple images are
being displayed, both static and real-time icons can be
superimposed on all of the displayed images. Other means of issuing
the storage command, such as, for example, through a GUI, may also
be used. The surgeon also has the option of storing multiple
instrument trajectories. Each time a desired storage command is
issued, the real-time trajectory of the instrument is stored and a
new static icon representing the stored trajectory is displayed on
the pre-acquired image, or if more than one image is being
displayed, on all the pre-acquired images.
[0034] The system according to the invention preferably has the
additional capability to measure angles between the real-time
trajectory and one or more of the stored trajectories, or between
stored trajectories, in a manner similar to that described in U.S.
Pat. No. 6,920,347, the disclosure of which is incorporated
herein.
[0035] In addition to tracking and storing instrument trajectory,
as will be described, neurological information can be acquired from
the patient and that information that can be represented in a
visible form that can be shown on display 12. For example, with the
aid of pre-acquired images and trajectory information, surgeon 42
may move the instrument 14 in a guided manner to an anatomical
region containing neural structures and using instrument 14 or
other neurologically stimulating device together with electrodes
(not shown) may then acquire neurological information from the
neural structures. The acquired neurological information is then
passed to computer 18 which registers the neurological information
with the neural structure from which the neurological information
was acquired. Based on the position of the instrument 14, computer
18 can determine the location of the neural structure that was
stimulated and then update the visualization of that neural
structure on display 12 to include markers or other indices
representative of the acquired neurological information. For
example, based on the location, orientation, and neurological
response, computer 18 can determine the class of the stimulated
neural structure and add an annotation to the visualization of the
neural structure on display 12. Alternately, the neural structure
may be assigned a designated color in the visualization on display
12 based on its class or other defining characteristics.
[0036] In addition to characterizing a stimulated neural structure,
computer 18, together with positional information of the neural
structure, may also predict the structure of the nerve and
graphically display that predicted structure to the surgeon on
display 12. In this regard, a portion of a nerve may be stimulated,
but the entire nerve structure predicted and graphically displayed.
Further, while the pre-acquired images and/or visualizations
thereof provide the surgeon with a general understanding of the
patient anatomy relative to the tracked instrument, the acquired
neurological information supplements that understanding with
greater precision with respect to neural structures. Thus, by
localizing the position of neural structures, the integrated system
enhances the surgeon's understanding of the anatomy for the
particular patient. To further assist the surgeon, through
localization of neural structures, viewable or audible indicators
may be automatically given by the computer 18 to the surgeon when
the instrument 14 is in proximity to a neural structure. Moreover,
the indicators may be tailored to coincide with the class,
position, or other characteristic of the neural structure.
[0037] Using voice recognition software and hardware, or other
input devices, surgeon 42 or other user may also add notes
regarding the neural structure from which a neurological response
was measured. Those notes may then be stored in memory of computer
18. In one embodiment, surgeon 42 wears a headphone 46 and
microphone 48 to facilitate hands-free note making during the
surgical procedure. As will be explained further below, computer 18
may also broadcast on-demand audio information to the surgeon via
an audio system connected to the headphone or other speakers.
[0038] Referring now to FIG. 3, a block diagram of the integrated
surgical navigational and neuromonitoring system 10 is shown.
Computer 18 includes a GUI system operating in conjunction with a
display screen of display monitor 12. The GUI system is implemented
in conjunction with operating system 46 running computer 18. The
GUI is implemented as part of the computer 18 to receive input data
and commands from a user interface 47 such as a keyboard, mouse,
lightwand, touchpad, touch screen, voice recognition module, foot
switch, joystick, and the like. For simplicity of the drawings and
explanation, many components of a conventional computer have not
been illustrated such as address buffers, memory buffers, and other
standard control circuits because these elements are well known in
the art and a detailed description thereof is not necessary for
understanding the present invention.
[0039] A computer program used to implement the various steps of
the present invention is generally located in memory unit 48, and
the processes of the present invention are carried out through the
use of a central processing unit (CPU) 50. The memory unit 48 is
representative of both read-only memory and random access memory.
The memory unit also contains a database 52 that stores data, for
example, image data and tables, including such information as
stored instrument positions, extension values, and geometric
transform parameters, used in conjunction with the present
invention. Database 52 can also be used to store data, such as
quantitative and qualitative assessments, of monitored neurological
structures. The memory unit further contains a technical data
database 53 that stores data pertaining to, for example, surgical
procedures, general anatomical structure information, videos,
publications, tutorials, presentations, anatomical illustrations,
surgical guides, and the like, that can be accessed by a surgeon or
other user preoperatively, intraoperatively, or postoperatively to
assist with diagnosis and treatment. Also contained in memory 48 is
a communication software module 60 that facilitates communication,
via modem 62, of the computer 18 to remote databases, e.g.,
technical data database 64.
[0040] It is understood that the single representations of an image
archival database and a technical data database is for
demonstrative purposes only, and it is assumed that there may be a
need for multiple databases in such a system. Additionally,
computer 18 may access the databases via a network (not shown).
According to the present invention, any acceptable network may be
employed whether public, open, dedicated, private, or so forth. The
communications links to the network may be of any acceptable type,
including conventional telephone lines, fiber optics, cable modem
links, digital subscriber lines, wireless data transfer systems, or
the like. In this regard, the computer 18 is provided with
communications interface hardware 62 and software 60 of generally
known design, permitting establishment of networks links and the
exchange of data with the databases.
[0041] CPU 50, in combination with the computer software comprising
operating system 46, tracking software module 54, calibration
software module 56, display software module 58, communication
module 60, and neuromonitoring software module 66 controls the
operations and processes of system 10. The processes implemented by
CPU 50 may be communicated as electrical signals along bus 68 to an
I/O interface 70 and a video interface 72. In addition to be
connected to user interface 47, the I/O interface is connected to a
printer 74, an image archive (remote or local) 76, and an audio
(speaker) system 78.
[0042] Tracking software module 54 performs the processes necessary
for tracking objects in an image guided system as described herein
and are known to those skilled in the art. Calibration software
module 56 computes the geometric transform which corrects for image
distortions and registers the images to the anatomical reference
frame 38, and thus the patient's anatomy.
[0043] Display software module 58 applies, and if desired, computes
the offsets between the guide tracking markers 40 and the
instrument 14 in order generate an icon representing the trajectory
of the instrument for superposition over the images. For
instruments with fixed lengths and angulations, these offsets can
be measured once and stored in database 52. The user would then
select from a list of instruments, the one being used in the
procedure so the proper offsets are applied by display software
module 58. For instruments with variable lengths and angulations,
the offsets could be measured manually and entered via keyboard 47,
or measured in conjunction a tracked pointer (not shown) or tracked
registration jig (not shown).
[0044] Pre-acquired image data stored locally in image database 52
or remotely in image archive 76 can be fed directly into computer
18 digitally through I/O interface 70, or may be supplied as video
data through video interface 72. In addition, items shown as stored
in memory can also be stored, at least partially, on a hard disk
(not shown) or other memory device, such as flash memory, if memory
resources are limited. Furthermore, while not explicitly shown,
image data may also be supplied over a network, through a mass
storage device such as a hard drive, optical disks, tape drives, or
any other type of data transfer and storage devices.
[0045] In addition to the modules and interfaces described above,
computer 18 includes a neuromonitoring interface 80 as well as an
instrument navigation interface 82. The neuromonitoring interface
80 receives electrical signals from electrodes 84 proximate patient
24. The electrical signals are detected by electrodes 84 in
response to electrostimulation applied to neural structures of the
patient by instrument 14 or other electrostimulating probe (not
shown). In this example, the electrodes are electromyography (EMG)
electrodes and record muscle response to nerve stimulation.
Alternately, other neuromonitoring techniques, such as, motor
evoked potentials (MEP) neuromonitoring and somatosensory evoked
potentials (SSEP) neuromonitoring, may be used. A stimulator
control 86 interfaces with instrument 14 and controls the
intensity, direction, and pattern of stimulation applied by
instrument 14. Inputs establishing desired stimulation
characteristics may be received by the surgeon or other user via
input interface 47 or on the instrument 14 itself.
[0046] As described above, the integrated system 10 also carries
out real-time tracking of instrument 14 (and patient 24) using
markers, reflectors, or other tracking devices. Alternately, the
instrument may include active devices such as signal emitters that
communicate with tracking equipment to determine a position or
orientation of the instrument. For example, the emitter may emit
infrared, RF, or other signals for tracking of the instrument. In
one example, instrument 14 includes markers 40 whose movements are
tracked by instrument tracker 88, which may include a camera or
other known tracking equipment. Similarly, the patient may include
markers or reflectors so that patient movement can be tracked. To
effectuate application of an electrical stimulus, instrument 14 is
also connected to a power supply 90. As will be shown, the
instrument 14 may be powered by a battery housed within the
instrument itself, a power supply housed within the computer
cabinet, or inductively. Thus, if active devices, such as emitter
or transmitters are used for tracking these devices can be
similarly powered.
[0047] The integrated surgical navigational and neuromonitoring
system is designed to assist a surgeon in navigating an instrument,
e.g., surgical tool, probe, or other instrument, through
visualization of the instrument relative to patient anatomy. As
described herein, using tracking tools and techniques, real-time
positional and orientation information regarding the instrument
relative to patient anatomy can be superimposed on an anatomical,
functional, or derived image of the patient. In addition to
assisting a surgeon with instrument tracking, the integrated system
10 also performs neuromonitoring to assess the position and
integrity of neural structures. In this regard, the surgeon can
move the instrument to a desired location, view the placement of
the instrument relative to patient anatomy on display 12, apply an
electrical stimulus to neural structures proximate the instrument,
and measure the response to that electrical stimulus. This neural
information gathered can then be added to the visualization of the
patient anatomy through graphic or textual annotations, color or
other coding of the neural structure, or other labeling techniques
to convey, in human discernable form, the neural information
gathered from the application of an electrical stimulus. The
integrated system also helps the surgeon in visualizing patient
anatomy, such as key nerve structures, and associating position or
integrity with the patient anatomy. As will be shown with respect
to FIGS. 4-5, a GUI is used to convey and facilitate interaction
with the surgical navigational and neuromonitoring information.
[0048] Referring now to FIG. 4, a GUI 92 designed to assist a
surgeon or other user in navigating a surgical tool, such as a
probe or a bone screwdriver, is shown. In the illustrated example,
the GUI 92 is bifurcated into an image portion 94 and a menu
portion 96. The image portion contains three image panes 98, 100,
102 that, in the illustrated example, contain a coronal, a
sagittal, and an axial image, respectively, of patient anatomy. The
image portion also contains a rendering pane 104. The menu portion
96 provides selectable links that, when selected by a surgeon,
enables interfacing with that displayed in the image panes 98, 100,
102 or with other data acquired from the patient.
[0049] The image panes provide an anatomical map or framework for a
surgeon to track an instrument, which can be representatively
displayed by pointer 106. The integrated system described herein
tracks movement of an instrument and provides a real-time
visualization of the position of the pointer superimposed on the
images contained in panes 98, 100, 102. It is noted that the
displayed images can be derived from one or more diagnostic images
acquired of the patient, an atlas model, or a combination thereof.
As the instrument is moved relative to the patient anatomy, the
images displayed in the image panes are automatically refreshed
such that an instantaneous position of the instrument, via pointer
106, provides positional information to the surgeon.
[0050] Moreover, as the integrated system supports both surgical
instrument navigation and neuromonitoring, the image panes and the
positional feedback provided by pointer 106 can assist the surgeon
in isolating a neural structure for neural monitoring. That is, a
general understanding of nerve location can be determined from the
images contained in the image panes 98, 100, 102. Through visual
inspection of the panes, the surgeon can then move the instrument
proximal a neural structure, apply an electrostimulation, and
measure the neurological response. That neurological response can
be used to assess the integrity of the neural structure in a manner
consistent with known neuromonitoring studies. Additionally, the
neurological information can also be used to localize more
precisely the position of the stimulated neural structure. For
example, the visualization of patient anatomy, e.g., the images
contained in panes 98, 100, 102, provides a general visual
understanding of anatomy position, orientation, and location. The
neurological response of a stimulated neural structure can then be
used to pinpoint the position and orientation of that neural
structure on the patient anatomy visualization using color-coding
or other indicia.
[0051] Moreover, based on the general location of a neural
structure and its localized position, assessment of the neural
structure can be enhanced. That is, the computer, using the
measured response of a neural structure and its positional
information, as indicated by the surgeon positioning the instrument
proximal the structure, can compare the measured response to data
contained in a database and determine if the measured response is
consistent with that expected given.
[0052] In addition to integrity assessment and positional
localization, the integration of the navigation and neuromonitoring
information enables the development of neural maps. That is,
through repeated movement of the instrument and neurological
monitoring, the combined information can be integrated to localize
neural structure position, classify those neural structures based
on position and/or response, and code through color or other
indicia, a neurological, anatomically driven map of the
patient.
[0053] It is noted that in the illustrated example, the tip of the
instrument is represented by pointer 106. However, it is
contemplated that tip, hind, or full instrument representations can
be used to assist with navigation. Also, while three images of the
same anatomy, but at different views are shown, other image display
approaches may be used.
[0054] Still referring to FIG. 4, one of the image panes 104 is
illustratively used for a three-dimensional rendering of a patient
anatomy, such as a neural structure bundle 108. The rendering can
be formed by registration of multi-angle images of the patient
anatomy, derived from atlas information, or a combination thereof.
In practice, the surgeon positions the instrument proximal a target
anatomical structure. The surgeon then, if desired, selects "3D
Rendering" tab 110 of menu 96. Upon such a selection, the computer
than determines the position of the pointer 106 and generates a 3D
rendering of the anatomical structure "pointed at" by the pointer.
In this way, the surgeon can select an anatomical feature and then
visually inspect that anatomical feature in a 3D rendering on the
GUI 92.
[0055] Further, as referenced above, the integrated system
maintains or has access to a technical library contained on one or
more databases. The surgeon can access that technical data through
selection of "Technical Data" tab 112. Upon such a selection, the
computer causes display of available resources (not shown) in menu
96. It is contemplated that another window may be displayed;
however, in a preferred implementation, a single GUI is used to
prevent superposition of screens and windows over the navigational
images. The technical resources may include links to internet web
pages, intranet web pages, articles, publications, presentations,
maps, tutorials, and the like. Moreover, in one preferred example,
the list of resources is tailored to the given position of the
instrument when the surgeon selects tab 112. Thus, it is
contemplated that access to the technical resource information can
be streamlined for efficient access during a surgical
procedure.
[0056] Menu 96 also includes a tracker sub-menu 114 and an
annotation sub-menu 116. The tracker sub-menu 114, in the
illustrated example, includes a "current" tab 118, a "past
trajectory" tab 120, and an "anticipated trajectory" tab 122 that
provide on-demand view options for displaying instrument navigation
information. User selection of tab 118 causes the current position
of the instrument to be displayed in the image panes. User
selection of tab 120 causes the traveled trajectory of the
instrument to be displayed. User selection of tab 122 causes the
anticipated trajectory, based on the current position of the head
of the instrument, to be displayed. It is contemplated that more
than a single tab can be active or selected at a time.
[0057] The annotations sub-menu 116 contains a "New" tab 124, a
"View" tab 126, and an "Edit" tab 128. Tabs 124, 126, 128
facilitate making, viewing, and editing annotations regarding a
surgical procedure and anatomical and neural observations. In this
regard, a surgeon can make a general annotation or record notes
regarding a specific surgical procedure or anatomical observation,
such as an observation regarding a neural structure, its position,
integrity, or neurological response. In one preferred example, the
computer automatically associates an annotation with the position
of the instrument when the annotation was made. Thus, annotations
can be made and associated with a neural or other structure during
the course of a surgical procedure. Moreover, by depressing the
"view" tab 126, the computer will cause a list of annotations to be
appear in pane 116. Alternately, or in addition thereto,
annotations made and associated with a neural structure will be
viewable by positioning the instrument proximal the neural
structure. Akin to a mouse-over technique, positioning the
instrument proximal an annotated neural structure will cause any
previous annotations to appear automatically if such a feature is
enabled.
[0058] It is understood that other tabs and selectors, both
general, such as a patient information tab 130, or specific, can be
incorporated into the menu pane 96. It is also understood that the
presentation and arrangement of the tabs in menu pane 96 is merely
one contemplated example.
[0059] Referring now to FIG. 5, image pane 102 is shown to further
illustrate instrument tracking. As described above, through user
selection of the appropriate input tab, the instantaneous position
of the instrument can be viewed relative to patient anatomy via
localization of pointer 106. Additionally, selection of the "past
trajectory" tab 120 on menu 96, FIG. 4, causes the past or traveled
trajectory of the instrument to be shown by dashed trajectory line
132. Similarly, the anticipated trajectory 134 can also be viewed
relative to the patient anatomy based on the instantaneous position
and orientation of the tip or leading portion of the
instrument.
[0060] Additionally, it is contemplated that trajectory paths can
be stored and that stored trajectories can be recalled and viewed
relative to the patient anatomy. In this regard, a current or
real-time instrument trajectory can be compared to past
trajectories. Moreover, it is recognized that not all instrument
movement is recorded. In this regard, the surgeon or other user can
turn instrument tracking on and off as desired. Also, although the
look-ahead technique described above projects the graphical
representation of the instrument into the image, there is no
requirement that the instrument's graphical representation be in
the space of the image to be projected into the image. In other
words, for example, the surgeon may be holding the instrument above
the patient and outside the space of the image, so that the
representation of the instrument does not appear in the images.
However, it may still be desirable to project ahead a fixed length
into the image to facilitate planning of the procedure.
[0061] In the illustrated example, a trajectory is represented by a
directional line. It is contemplated, however, that other
representations may be used. For example, a trajectory can be
automatically assigned a different color or unique numerical label.
Other types of directional indicators may also be used, and
different shapes, styles, sizes, and textures can be employed to
differentiate among the trajectories. The surgeon also has the
option of not showing the label for any trajectory if desired. The
surgeon also has the option of changing the default color or label
text for any trajectory through appropriate controls contained in
menu 96. In one example, past trajectories are assigned one color
whereas anticipated or look-ahead trajectories are assigned a
different color. Also, while on a single trajectory is illustrated
in FIG. 5, it is recognized that multiple instruments can be
tracked at a time and their trajectories tracked, predicted, and
displayed on the image.
[0062] As described with respect to FIGS. 1-5, the integrated
system 10 tracks the position of an instrument, such as a surgical
tool or probe, relative to patient anatomy using markers,
reflectors, and the like. In one aspect, the instrument is also
capable of applying an electrical stimulus to a neural structure so
that neurological information, such as nerve position and nerve
integrity, can be determined without requiring introduction of
another instrument to the patient anatomy. The instrument can be
tethered to a computer 18 via a stimulator control interface 86 and
a power supply 90, or, in an alternate embodiment, the instrument
can be wirelessly connected to the stimulator control interface 86
and be powered inductively or by a self-contained battery.
[0063] FIG. 6 illustrates operational circuitry for inductively
powering the instrument and for wirelessly determining positional
information of an instrument rather than using markers and
reflectors. The operational circuitry 136 includes a signal
generator 138 for generating an electromagnetic field. The signal
generator 138 preferably includes multiple coils (not shown). Each
coil of the signal generator 138 may be activated in succession to
induce a number of magnetic fields thereby inducing a corresponding
voltage signal in a sensing coil.
[0064] Signal generator 138 employs a distinct magnetic assembly so
that the voltages induced in a sensing coil 140 corresponding to a
transmitted time-dependent magnetic field produce sufficient
information to describe the location, i.e. position and
orientation, of the instrument. As used herein, a coil refers to an
electrically conductive, magnetically sensitive element that is
responsive to time-varying magnetic fields for generating induced
voltage signals as a function of, and representative of, the
applied time-varying magnetic field. The signals produced by the
signal generator 138 containing sufficient information to describe
the position of the instrument are referred to hereinafter as
reference signals.
[0065] The signal generator is also configured to induce a voltage
in the sensing coil 140 sufficient to power electronic components
of the instrument, such as a nerve stimulation unit 142 and a
transmitter 144. In the preferred embodiment, the signals
transmitted by the signal generator 138 for powering the device,
hereinafter referred to as powering signals, are frequency
multiplexed with the reference signals. The frequency ranges of the
reference signal and powering signal are modulated so as to occupy
mutually exclusive frequency intervals. This technique allows the
signals to be transmitted simultaneously over a common channel,
such as a wireless channel, while keeping the signals apart so that
they do not interfere with each other. The reference and positional
signals are preferably frequency modulated (FM); however, amplitude
modulation (AM) may also be used.
[0066] Alternatively, the powering signals may be transmitted by
separate signal generators, each at a differing frequencies. As
embodied herein, the portion for receiving a reference signal
further includes a sensing unit 146 and a power circuit 148.
Sensing unit 146 and power circuit 148 each may receive an induced
voltage signal due to a frequency multiplexed reference signal and
powering signal on sensing/powering coil 140. Sensing unit 146 and
power circuit 148 both may separate the voltage signals induced by
the multiplexed magnetic signals into positional and powering
signals.
[0067] The sensing unit 146 measures the induced voltage signal
portion corresponding to a reference signal as a positional signal
indicative of a current position of the instrument. The positional
signal is transmitted by transmitter 144. Similarly, power circuit
148 may retain the induced voltage signal portion corresponding to
a powering signal for producing power sufficient to power the
transmitter 144 and apply electrostimulation to a neural structure.
Power circuit 148 rectifies the induced voltage generated on the
coil 140 by the powering signals to produce DC power that is used
power the transmitter 144 and the nerve stimulation unit 142. Power
circuit 148 may store the DC power using a capacitor, small
battery, or other storage device for later use.
[0068] The integrated system 10 includes an electromagnetic control
unit 150 that regulates operation of the signal generator 138 and
includes a receiver (not shown) for receiving the positional
information transmitted wirelessly by the transmitter 144. In this
regard, the control unit 150 is adapted to receive magnetic field
mode positional signals and transmit those positional signals to
the CPU for processing to determine the position and/or orientation
of the instrument. The CPU preferably begins determining the
position of the instrument by first determining the angular
orientation of the sensing coil 140 and then using the orientation
of the coil 140 to determine the position of the instrument.
However, the present invention is not limited to any specific
method of determining the position of the instrument. While a
single sensing/powering coil 140 is shown, it is contemplated that
separate sensing and powering coils may be used.
[0069] As described herein, in one aspect of the disclosure, a
surgical instrument, such as a probe, a retractor, or a bone
screwdriver is also used to apply an electrical stimulus to a
neural structure. In addition to applying electrostimulation, the
surgical instruments can be equipped with appropriate circuitry and
controls to remotely control the neuromonitoring and navigational
system. FIGS. 7-14 and 18 illustrate various examples of integrated
surgical and electro stimulating tools.
[0070] FIG. 7 illustrates a surgical probe 152 that includes an
elongated and, preferably, textured handle 154 having a proximal
end 156 and a distal end 158. The surgical probe 152 is connectable
to the neuromonitoring interface 80, FIG. 3, by jacks 160 extending
from the handle proximal end 156. Handle includes a transversely
projecting actuator 162 proximate a tapered distal segment 164
terminating in handle distal end 158 which carries a distally
projecting stainless steel shaft 166. Shaft 166 is tapered and
preferably has a larger outside diameter proximate the handle
distal end 158, tapering to a smaller outside diameter proximate
the shaft distal end 168, with a distally projecting length from
handle distal end 158 to shaft distal end 168 encased in clear
plastic, thin-wall, shrinkable tubing. Extending from the handle
154 and electrically connected to conductors 170 is an anode 172
and a cathode 174. The anode and cathode 172, 174 extend slightly
past the shaft distal end 168 and are used to apply
electrostimulation to a neural structure.
[0071] The outer surface of the handle 154 also includes a
reflector/marker network 176 to facilitate tracking of the position
and orientation of the probe 152. The probe 152 is shown as having
three reflectors 176 that may be permanently or removably fixed to
the handle 154. As is known in conventional surgical instrument
tracking systems, the size, shape, and position of the reflectors
176 are known by the surgical navigational system, thus, when
captured by a camera, the position and orientation of the probe 152
can be readily ascertained. It is recognized that more than or less
than three reflectors may be used.
[0072] The actuator 162 enables the surgeon to selectively apply
electrostimulation to patient anatomy during a surgical procedure.
As such, the probe 152 can be used for surgical purposes without
the application of electrostimulation and, when desired by the
surgeon, used to illicit a neurological response from a neural
structure. In the embodiment illustrated in FIG. 7, the probe 152
is powered by a power supply (not shown) external to the probe 152
via the jacks 160.
[0073] In FIG. 8, a battery powered retractor according to another
embodiment of the invention is shown. Retractor 178 includes
elongated and, preferably, textured handle 180 having a proximal
end 182 and a distal end 184. Extending from the distal end 184 is
a tapered shaft 186 that terminates in a curved head 188 that
includes an anode tip 190 and a cathode tip 192, that are coplanar
with one another. The handle 180 provides an interior volume 194
sized and shaped to hold batteries 196 that supply power sufficient
to electrostimulate neural structures when desired by the surgeon.
In one embodiment, the batteries 196 are permanently sealed within
the interior volume 194 of the handle 180 so as to prevent contact
with body fluids and cleaning fluids. In another embodiment, not
illustrated herein, the batteries are removable and therefore
replaceable by threadingly removing a cap portion of the handle. It
is contemplated that rechargeable batteries may be used and that
the batteries may be recharged without removing them from the
handle.
[0074] The handle 180 also includes three reflectors 198 that
provide visual feedback to a camera (not shown) or other detection
device to determine the position and orientation of the retractor.
Similar to that described with respect to FIG. 7, the retractor 178
further includes an actuator 200 that enables a surgeon to
selectively turn the electrostimulation functionality of the
retractor 178 on so as to apply electrostimulation to a neural
structure.
[0075] FIG. 9 illustrates a corded retractor 202 according to the
present disclosure. In this example, the retractor 202 is powered
by a remote battery or other power supply through a conventional
jack connection using jacks 204. Like that described with respect
to FIG. 8, the handle 206 of the retractor 202 includes reflectors
208 to enable surgical navigational hardware and software to track
the position and orientation of the retractor 202. Retractor 202
also includes an actuator 210 to selectively apply
electrostimulation to a neural structure. Electrostimulation is
facilitated by an anode conductor 212 and a cathode conductor 214
extending past the shaft 216. The anode and cathode conductors 212,
214 extend along the entire length of the shaft 216 and connect to
a power supply via connection with jack connectors 217.
[0076] For both retractor examples it is contemplated that the
position and orientation of a retractor can be monitored and,
accordingly, the retractor can be opened and closed automatically
to prevent neuron-related damage by extended retraction.
[0077] In another example, as shown in FIG. 10, a bone screwdriver
218 is configured to provide electrostimulation in addition to
driving a bone screw. Screwdriver 218 includes a handle 220 with a
driving shaft 222 extending from a distal end thereof. The handle
220 is sized to accommodate batteries 224 to provide power for
electrostimulation. The handle 20 also includes reflectors 226
secured thereto in either a permanent or removable fashion. The
driving shaft 222 extends from the distal end 228 of the handle 220
to a driving head 230 sized and shaped to accommodate driving of
bone screw. Extending parallel to the driving shaft 222 are
sheathed anode and cathode electrodes 232, 234. The sheathed
electrodes 232, 234, when extended, extend beyond the driving head
230 of the driving shaft 222. The sheathed anode and cathode
electrodes 232, 234 are preferably retractable so as to not
interfere with the surgeon during driving of a bone screw.
[0078] The sheathed electrodes 232, 234 are extended and retracted
manually by the surgeon using an eyelet 236. Preferably, the eyelet
is positioned in sufficient proximity to the handle 220 so that a
surgeon can extend and retract the electrodes 232, 234 while
holding the handle 220 and be able to depress the actuator 238 to
apply the electrical stimulation. Accordingly, the handle includes
a cavity (not shown) defined by appropriate stops to define the
range of translation of the electrodes.
[0079] FIG. 11 is an elevation view of a surgical tap according to
another aspect of the present disclosure. In this example, a
surgical tap 240 is constructed for pedicle hole preparation, but
is also capable of neurostimulation and providing navigational
information. In this regard, the surgical tap 240 includes a handle
242 with a conductive shaft 244 extending therefrom. An insulating
sheath 246 surrounds only a portion of the shaft so as to limit
electrostimulation to the conductive tip 248. The conductive tip
248 includes a series of threads 250 that engage the pedicle or
other bony structure during insertion of the tap. The threads 250
are formed such that a longitudinal recess or channel 252 is
defined along the length of the tip.
[0080] Handle 242 has an actuator switch 254 that allows a user to
selectively apply electrostimulation during insertion of the tip.
As such, electrostimulation can be applied while the surgical tap
is forming a pedicle screw pilot hole or probing of the pedicle.
Energy is applied to the conductive tip 248 via conductor 256,
which is connectable to an energy source of the neuromonitoring
system, FIG. 1. Alternatively, batteries can be disposed in the
handle and used to supply electrostimulating energy to the
conductive tip 248.
[0081] The handle 242 also has three reflectors 258 which provide
visual feedback to a camera (not shown) or other detection device
to determine the position and orientation of the tap. One skilled
in the art will recognize that other techniques may be used to
track the position of the tap, such as electronic position sensors
in the handle.
[0082] FIG. 12 shows a surgical probe 260 according to another
embodiment of the present disclosure. Similar to the examples
described above, probe 260 has a handle 262 with a series of
reflectors 264 coupled to or otherwise formed thereon. Extending
from the proximate end of the handle are jacks 266 for connecting
the probe 260 to the energy source of the neuromonitoring system,
FIG. 2. Extending from the distal end of the handle 262 is a
conductive shaft 268 partially shrouded by an insulating sheath
270. The unsheathed portion of the shaft 268 is a conductive tip
272 capable of probing the pedicle or other bony structure. The
handle also has an actuator 274 for selectively energizing the
conductive tip 272 for the application of electrostimulation during
probing.
[0083] FIG. 13 is a cross-sectional view of the conductive tip 272.
As shown, the conductive shaft 268 includes an anode conductive
portion 274 and a cathode conductive portion 276 separated from the
anode conductive portion 274 by an insulator 278. This is further
illustrated in FIG. 14. With this construction, electrostimulation
is applied between the anode conduction portion 276 and the
electrically isolated cathode conductive portion 274 for bipolar
electrostimulation.
[0084] The illustrative tools described above are designed to not
only perform a surgical function, but also apply electrostimulation
to a neural structure of the patient. As described herein, with the
aid image based navigation, a surgeon can move the instrument,
visualize that movement in real-time, and apply electrostimulation
(uni-polar and bi-polar) as desired at various instrument positions
without the need for a separate stimulation instrument. Further,
electrostimulation can also be applied to enhance navigation
through the application of a leading electrostimulation pattern. In
this regard, as the instrument is traversed through the patient
anatomy, electrostimulation is automatically applied ahead of the
tip of the instrument. As such, neurological information is
automatically acquired as the instrument is moved and the
visualization of patient anatomy automatically updated to
incorporate the neurological information. Moreover, the
neurological information can be used to localize, with better
specificity, the actual location and orientation of neural
structures. For example, electrostimulation with a broadcasting
scope can be applied as the instrument is moved. If a neurological
response is not measured, such a broad electrostimulation
continues. However, if a neurological response is measured, a
pinpointing electrostimulation can be repeatedly applied with
decreasing coverage to localize the position of the stimulated
neural structure.
[0085] Referring now to FIG. 15, in a further example, the leading
electrostimulation can also be used to signal to the surgeon that
the instrument is approaching a nerve or other neural structure.
The signal may be a visual identifier on the GUI or in the form of
an audible warning broadcast through the audio system described
herein. In this regard, the integrated system determines the
instantaneous position of the instrument at 280. The system then
compares the position of the instrument with information regarding
the anatomical makeup of the patient to determine the proximity of
the instrument to neural structures that may not be readably
visible on the anatomical visualization at 282. If the instrument
is not near a neural structure 282, 284, the process loops back to
step 280. If the instrument is at or near a previously identified
neural structure 282, 286, the neural structure is identified or
classified from an anatomical framework of the patient and/or the
neurological response of the structure. Once the neural structure
is identified 288, an appropriate signal is output 290 signaling
that the instrument is near a neural structure. It is contemplated
that the intensity and identification afforded the signal may be
based on the type of neural structure identified as being proximal
the instrument. For example, the volume and the pattern of an
audible alarm may vary depending upon the type of neural structure.
Further, in the example of audible proximity indicators, the volume
and/or pattern of audible alarm may change as the instrument moves
closer to or farther away from the neural structure. Thus, the
audible signals provide real-time feedback to the surgeon regarding
the position of the instrument relative to a neural structure.
After the appropriate signal is output, the process returns to
determining the position of the instrument at 280.
[0086] As described above, the integrated system is also capable of
performing measurements between trajectories or instrument
positions. Thus, for example, bone measurements can be done to
determine if sufficient bone has been removed for a particular
surgical procedure. For instance, the instrument can be tracked
across the profile of a portion of a bone to be removed. The
trajectory across the profile can then be stored as a trajectory.
Following one or more bone removal procedures, the instrument can
again be tracked across the bone now having a portion thereof
removed. The system can then compute the differences between those
trajectories and provide a quantitative value to the surgeon, via
the GUI, for example, to assist the surgeon in determining if
enough bone has been removed for the particular surgical
procedure.
[0087] Also, the characteristics of the electrostimulation can be
automatically adjusted based on the tracked instantaneous position
of the instrument. That is, the integrated system, through
real-time tracking of the instrument and a general understanding of
patient anatomy layout from images, atlas models, and the like, can
automatically set the intensity, scope, and type of
electrostimulation based on the anatomy proximal the instrument
when the surgeon directs application of electrostimulation. Rather
than automatically set the electrostimulation characteristics, the
system could similar display, on the GUI, the electrostimulation
values derived by the system for consideration by the surgeon. In
this regard, the surgeon could adopt, through appropriate inputs to
the GUI, the suggested characteristics or define values different
from those suggested by the system. Also, since an instrument could
be used for bone milling or removal and electrostimulation,
neurological responses could be measured during active milling or
bone removal.
[0088] While an integrated surgical navigational and
neuromonitoring system has been described, it is recognized that
stand-alone systems may be communicatively linked to one another in
a handshake fashion. Thus, through software modules, such as those
described herein, the neuromonitoring information provided by a
stand-alone neuromonitoring probe and system can be provided to a
stand-alone surgical navigational system for the integrated
visualization of navigational and neuromonitoring information.
[0089] As described herein, the integrated system is also capable
of providing on-demand access to technical resources to a surgeon.
Moreover, the integrated system is designed to provide a list of
on-demand resources based on instrument position, neural structure
position, or neural structure neuroresponse. As set forth in FIG.
16, the integrated system is designed to receive a user input 292
from the surgeon or other user requesting publication of a
technical resource. Responsive to that input, the integrated system
determines the instantaneous position of the instrument 294 when
the request is made. Based on the instrument position, anatomical
structures proximal the instrument are then determined 296. From
the position of the instrument, the identified proximal anatomy,
and, if applicable, the neurological response of a proximal neural
structure, the system accesses corresponding portions of a
technical resource database 298 to derive and display a list of
related technical resources available for publication to the
surgeon at 300. The list is preferably in the form of selectable
computer data links displayed on the GUI for surgeon selection and
may link to articles, publications, tutorials, maps, presentations,
video, instructions, and manuals, for example. In response to a
user selection on the GUI 302, the selected technical resource is
uploaded from the database and published to the surgeon or other
user at 304. It is contemplated that the integrated system may
upload the technical resource from a local or remote database.
[0090] Another process capable of being carried out by the
integrated system described herein is shown in FIG. 17. FIG. 17
sets forth the steps of a predictive process for providing feedback
to a surgeon or other is assessing neural integrity. The process
begins at step 306 with determining a position of the
electrostimulation instrument when an electrostimulation is
applied. The location of the stimulated neural structure is also
determined at 308. Based on the location of the neural structure,
the neural structure is identified 310. Identification of the
neural structure can be determined from comparing anatomical
information of the patient with previous neural maps, atlas models,
anatomical maps, and the like. Based on identification of the
neural structure, e.g., class, the neurological response of the
neural structure to the electrostimulation is predicted 312. The
predicted neurological response is then compared to the actual,
measured neurological response at 314. The results of that
comparison are then conveyed at 316 to the surgeon or other user
with the GUI to assist with determining the neural integrity of the
stimulated neural structure. Additionally, the visualization of the
stimulated and measured neural structure can be automatically
updated based on the comparison, e.g., color coded or annotated to
indicate that the neurological response was not in line with that
expected.
[0091] FIGS. 7-14 illustrate various examples of surgical
instruments in accordance with the present disclosure. FIG. 18
illustrates another surgical instrument according to the present
disclosure. Specifically, FIG. 18 illustrates a NIM probe 318 that
can be used to apply electrostimulation to a neural structure. The
NIM probe can also be used for forming a pilot hole in a pedicle
such that neuromonitoring can be performed during pilot hole
formation.
[0092] The illustrated NIM probe is similar in general construction
to that described in U.S. Patent Application Publication No.
2006/0173521, the disclosure of which is incorporated herein by
reference. The NIM probe 318 includes a needle assembly 320 and a
handle assembly 322. Needle assembly 320 can be electrically
connected to a nerve monitoring system 324 via lead 326. Lead 326
extends through handle assembly 322 and is electrically connected
to stylet 328. The stylet 328 is positioned internally of an
insulating cannula 330. In this regard, the stylet 328 distally
projects from the cannula 330. The distally projecting portion of
stylet 328 includes a tip portion 332 that can be used for piercing
skin, soft or hard tissues, pedicle pilot hole formation, and
applying an electro stimulus to a neural structure. The NIM probe
318 optionally includes a sheath 334 surrounding a portion of
cannula 330 and/or stylet 328. Preferably, cannula 330 and sheath
334 are formed of non-electrically conductive material. In this
regard, the unexposed portions of the stylet are electrically
isolated from tissues adjacent the NIM probe when the tip portion
332 is energized.
[0093] The NIM probe also includes navigational sensors 336
positioned at various points on the cannula, sheath, and handle
assembly 322. In one example, the sensors are passive devices,
e.g., reflectors. In another example, the sensors are active
devices, e.g., emitters or transmitters. In yet a further example,
a combination of passive and active devices is used. The active
devices may be powered by the energy supplied to the NIM probe from
the nerve monitoring system 324. Alternatively, the active devices
may be independently powered, such as with batteries. The sensors
336 communicate with a surgical navigation system, such as that
described herein, that determines a position and/or orientation of
the instrument in real-time. As described above, a user interface
can then be updated to include a visualization of the instrument
(or portions thereof, e.g., stylet tip) relative to patient anatomy
to assist a surgeon with instrument navigation, and patient
diagnosis.
[0094] While a probe, a retractor, a screwdriver, and a tap have
been shown and described, it is contemplated that other surgical
tools according to the present disclosure may be used to carry out
surgical functions as well as apply electrostimulation, such as
blunt dilators, awls, pedicle access needles, biopsy needles, drug
delivery needles, ball tip probes, inner body dilators, spinal disc
removal tools, inner body spacer tools, soft tissue retractors,
gloves, finger covers, tool guides, and others. Additionally, it is
contemplated that an implant, such as a pedicle screw, disc, or
nucleus replacement, when coupled to a conductive portion of a
surgical tool, may also be conductive and thus used to apply
electrostimulation during implantation of the implant. For example,
a bone screw may also be used to apply electrostimulation when
engaged with the driving and conductive end of a driver. Also,
while surgical instruments having reflectors for optically
determining instrument position and orientation have been
illustratively shown, the surgical instruments may include
circuitry such as that described with respect to FIG. 6 for
electromagnetically determining instrument position and orientation
and inductively powering the electro stimulation and transmitter
circuits. Furthermore, the surgical tools can be adapted to control
parameters of the surgical navigational and neuromonitoring
systems. It also contemplated that the surgical tools can
communicate with the navigational and neuromonitoring systems via a
wireless or wired connection. It is further contemplated that the
magnitude of electro stimulation can be pre-defined or
automatically determined based on the relative position and
orientation of the instrument. Thus, the electrostimulation
intensity and pattern can be automatically determined based on the
position of the instrument.
[0095] The surgical instruments described herein illustrate various
examples in which the present disclosure can be implemented. It is
recognized that other instruments other than those described can be
used. Further, preferably, the instruments are formed of
bio-compatible materials, such as stainless steel. It is recognized
however that other bio-compatible materials can be used. Also, it
is recognized that non-tip portions of an instrument may be used
for applying electrostimulation. For example, a dilator or
retractor blade may be constructed such that multiple electrodes
are defined along the length of the instrument. As such,
electrostimulation could be selectively applied along the length of
the instrument.
[0096] Although only a few exemplary embodiments have been
described in detail above, those skilled in the art will readily
appreciate that many modifications are possible in the exemplary
embodiments without materially departing from the novel teachings
and advantages of this disclosure. Accordingly, all such
modifications and alternative are intended to be included within
the scope of the invention as defined in the following claims.
Those skilled in the art should also realize that such
modifications and equivalent constructions or methods do not depart
from the spirit and scope of the present disclosure, and that they
may make various changes, substitutions, and alterations herein
without departing from the spirit and scope of the present
disclosure. It is understood that all spatial references, such as
"horizontal," "vertical," "top," "upper," "lower," "bottom,"
"left," "right," "cephalad," "caudal," "upper," and "lower," are
for illustrative purposes only and can be varied within the scope
of the disclosure. Further, the embodiments of the present
disclosure may be adapted to work singly or in combination over
multiple spinal levels and vertebral motion segments. Also, though
the embodiments have been described with respect to the spine and,
more particularly, to vertebral motion segments, the present
disclosure has similar application to other motion segments and
parts of the body. In the claims, means-plus-function clauses are
intended to cover the elements described herein as performing the
recited function and not only structural equivalents, but also
equivalent elements.
* * * * *