U.S. patent application number 13/013655 was filed with the patent office on 2011-05-19 for system and method for surgical instrument disablement via image-guided position feedback.
This patent application is currently assigned to Vanderbilt University. Invention is credited to J. Michael Fitzpatrick, Robert F. Labadie.
Application Number | 20110118597 13/013655 |
Document ID | / |
Family ID | 35056711 |
Filed Date | 2011-05-19 |
United States Patent
Application |
20110118597 |
Kind Code |
A1 |
Labadie; Robert F. ; et
al. |
May 19, 2011 |
SYSTEM AND METHOD FOR SURGICAL INSTRUMENT DISABLEMENT VIA
IMAGE-GUIDED POSITION FEEDBACK
Abstract
A system for selectively disabling a surgical instrument
operating in a surgical site of a region of interest of a living
subject. In one embodiment, the system includes means for
noninvasively placing a number of fiducial markers in an anatomic
space of the region of interest of the living subject, means for
pre-operatively measuring a location of each fiducial marker in the
anatomic space, an imaging acquisition device for pre-operatively
acquiring an image volume from the region of interest of the living
subject, a probe for intra-operatively monitoring a location of the
surgical instrument in the anatomic space, and a controller
configured to perform the steps of identifying a centroid of each
fiducial marker in the image volume, registering the identified
centroid of each fiducial marker in the image volume to the
measured location of the corresponding fiducial marker in the
anatomic space to determine a registration transformation, mapping
the monitored location of the surgical instrument in the anatomic
space onto a corresponding location in the image volume by an
inverse of the registration transformation, and generating a signal
to disable the surgical instrument when the mapped location of the
surgical instrument is substantially close to a boundary of the
surgical site of the region of interest in the image volume.
Inventors: |
Labadie; Robert F.;
(Nashville, TN) ; Fitzpatrick; J. Michael;
(Nashville, TN) |
Assignee: |
Vanderbilt University
Nashville
TN
|
Family ID: |
35056711 |
Appl. No.: |
13/013655 |
Filed: |
January 25, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11079898 |
Mar 14, 2005 |
7899512 |
|
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13013655 |
|
|
|
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60555377 |
Mar 22, 2004 |
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Current U.S.
Class: |
600/426 |
Current CPC
Class: |
A61B 2017/00123
20130101; A61B 2017/00022 20130101; A61B 34/10 20160201; A61B 90/16
20160201; A61B 2017/00057 20130101; A61B 2090/372 20160201; A61B
2017/00106 20130101; A61B 2090/3954 20160201; A61B 2034/2055
20160201; A61B 2034/2072 20160201; A61B 2090/08021 20160201; A61B
2090/364 20160201; A61B 2017/00035 20130101; A61B 2090/3983
20160201; A61B 2090/363 20160201; A61B 2090/502 20160201; A61B
2090/374 20160201; A61B 90/10 20160201; A61B 34/20 20160201; A61B
90/39 20160201; A61B 2034/2051 20160201; A61B 2017/00216 20130101;
A61B 17/24 20130101; A61B 90/06 20160201; A61B 2090/0801 20160201;
A61B 90/36 20160201 |
Class at
Publication: |
600/426 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Goverment Interests
STATEMENT OF FEDERALLY-SPONSORED RESEARCH
[0003] The present invention was made with Government support under
a contract R21 EB02886-02 awarded by National Institutes of Health.
The United States Government may have certain rights to this
invention pursuant to these grants.
Claims
1-19. (canceled)
20. A system for selectively disabling a surgical instrument
operating in a surgical site of a region of interest of a living
subject, wherein the surgical instrument has a distal end portion
and is operable by a surgeon during a surgery, comprising: (a) a
probe for intra-operatively monitoring a physiological condition of
the living subject in the region of interest during the surgery;
and (b) a controller operatively coupled with the surgical
instrument and the probe, respectively, and configured to perform
during the surgery the steps of: (i) determining a variation of the
physiological condition of the living subject from an initial state
of the living subject in the region of interest; and (ii)
generating a signal to disable the surgical instrument when the
variation of the physiological condition is greater then a
predetermined value, wherein the probe comprises at least one of a
needle electrode placed in the region of interest of the living
subject, a Doppler vascular probe, a temperature sensing device, an
oxygenation detector, and a tissue boundary detector.
21. The system of claim 20, further comprising at least one of a
display and an audio device for visually and/or audibly displaying
the intra-operatively monitored physiological condition of the
living subject in the region of interest, respectively.
22. (canceled)
23. The system of claim 20, wherein the physiological condition
comprises an electromyogram of electrical activities of muscles of
the region of interest of the living subject.
24. (canceled)
25. The system of claim 20, wherein the physiological condition
comprises a flow rate of blood vessels of the region of interest of
the living subject.
26. (canceled)
27. The system of claim 20, wherein the physiological condition
comprises a temperature of tissues of the region of interest of the
living subject.
28. (canceled)
29. The system of claim 20, wherein the physiological condition
comprises a venous oxygenation saturation and an arterial
oxygenation saturation of the region of interest of the living
subject.
30. (canceled)
31. The system of claim 20, wherein the tissue boundary detector
comprises at least one of an ultrasound sensing device, an infrared
radiation sensing device, an ultraviolet radiation sensing device,
a fluorescent radiation sensing device, and a video frame
device.
32. The system of claim 31, wherein the physiological condition
comprises a tissue type identification of tissues at the distal end
portion of the surgical instrument in the region of interest of the
living subject.
33. The system of claim 32, wherein the physiological condition
comprises a volume of suction from the region of interest of the
living subject.
34. A method for selectively disabling a surgical instrument
operating in a surgical site of a region of interest of a living
subject, wherein the surgical instrument has a distal end portion
and is operable by a surgeon during a surgery, comprising the steps
of: (a) intra-operatively monitoring a physiological condition of
the living subject in the region of interest during the surgery;
(b) determining a variation of the physiological condition of the
living subject from an initial state of the living subject in the
region of interest, during the surgery; and (c) generating a signal
to disable the surgical instrument when the variation of the
physiological condition is greater than a predetermined value,
wherein the physiological condition comprises at least one of an
electromyogram of electrical activities of muscles of the region of
interest of the living subject, a flow rate of blood vessels of the
region of interest of the living subject, a temperature of tissues
of the region of interest of the living subject, a venous
oxygenation saturation and an arterial oxygenation saturation of
the region of interest of the living subject, a tissue type
identification of tissues at the distal end portion of the surgical
instrument in the region of interest of the living subject, and a
volume of suction from the region of interest of the living
subject.
35-40. (canceled)
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATION
[0001] This application claims the benefit, pursuant to 35 U.S.C.
.sctn.119(e), of provisional U.S. patent application Ser. No.
60/555,377, filed Mar. 22, 2004, entitled "SURGICAL INSTRUMENT
DISABLEMENT VIA IMAGE-GUIDED POSITION FEEDBACK," by Robert F.
Labadie, and J. Michael Fitzpatrick, which is incorporated herein
by reference in its entirety.
[0002] Some references, which may include patents, patent
applications and various publications, are cited and discussed in
the description of this invention. The citation and/or discussion
of such references is provided merely to clarify the description of
the present invention and is not an admission that any such
reference is "prior art" to the invention described herein. All
references cited and discussed in this specification are
incorporated herein by reference in their entireties and to the
same extent as if each reference was individually incorporated by
reference. In terms of notation, hereinafter, "[n]" represents the
nth reference cited in the reference list. For example, [7]
represents the 7th reference cited in the reference list, namely,
West J B, Fitzpatrick J M, Toms S, Maurer, Jr, and Maciunas R J.
Fiducial point placement and the accuracy of point-based,
rigid-body registration. Neurosurgery 48: 810-817, 2001.
FIELD OF THE INVENTION
[0004] The present invention generally relates to a
computer-assisted surgery and in particular to the utilization of a
feedback trigger during a surgery to selectively disable a surgical
instrument operating in a region of interest of a living
subject.
BACKGROUND OF THE INVENTION
[0005] Radiographic imaging is often imperative for the
pre-operative planning of surgical treatments for patients. Plain
X-rays, computed tomography (hereinafter "CT") images, and magnetic
resonance (hereinafter "MR") images facilitate surgical
navigations. Because on their usefulness, surgeons have sought
innovative ways to further incorporate radiographic imaging into
the surgical suite. For years, orthopedic and vascular surgeons
have relied upon intra-operative, real-time fluoroscopy, such as
plain X-rays, to assess surgical treatments. More recently,
real-time MR [1] and CT imaging surgical suites have been
constructed where intra-operative MR or CT image is continuously
updated displaying anatomic changes due to surgical treatment.
These systems have found limited use due to logistic difficulties
including the exorbitant cost of a dedicated CT or MR imaging
system in an operative suite and the physically confined
environment in which a surgeon operates.
[0006] A more feasible option has been the use of pre-operative CT
and/or MR images in an image-guided surgery (hereinafter "IGS")
where anatomic locations are continuously updated on the
per-operative CT and/or MR images as specified by a surgical probe.
The concept of the image-guided surgery dated back to the 1940's
[3]. However, widespread acceptance of the concept did not occur
until radiographic advances in the 1970's that made CT and MR
images routinely available. Image-guided surgical systems, which
are analogous to global-positioning systems (hereinafter "GPS"),
have since found widespread use in neurosurgery [4] and sinus
surgery [5]. In general, An IGS system includes a pre-operative
radiographic image (CT or MR image) that is acquired from a patient
and digitized and stored on a computer. Within the operating room
(hereinafter "OR"), the pre-operative radiographic image are
registered to the anesthetized patient by correlating landmarks
found on the pre-operative radiographic image with the landmarks on
the anesthetized patient. Typical landmarks used for registration
are anatomic points and/or fiducial markers attached to the skin or
implanted in bone of a patient. Registration creates a
transformation matrix that allows a direct mapping of the patient's
current anatomy to the corresponding pre-operative radiographic
image. Once registration has taken place, for example, using an
electronically visible probe, such as infrared optical system
and/or electromagnetic system, to detect a location of each
fiducial marker in the patient, i.e., the physical space, that is
registered to in a radiographic image space. The probe can be used
as a pointer to identify surgical anatomy on CT or MR images.
[0007] Crucial to limiting error in IGS systems is registration of
the pre-operative radiographic image to the surgical field of
interest in the anesthetized patient.
[0008] Registration landmarks, for example, anatomic landmarks
and/or fiducial markers, need to be immobile relative to the
anatomy and arranged such that they surround the surgical field of
interest. While multiple anatomic landmarks would initially appear
useful, soft tissue, for instance, skin and muscle, relaxes and
distorts under general anesthesia making boney landmarks necessary
for accurate registration. A solution has been to implant markers
into bone of a patient. This is routinely used in neurosurgery
where screws are placed into the cranium prior to pre-operative
radiographic imaging and these screws serve as landmarks for
registration. While accuracy with such systems is impressive [6,
7], it does involve the invasive placement of bone screws with
small, yet real, risk of infection and cosmetic deformity. Another
solution is to use skin markers or skin contours. Such systems have
shown decreased accuracy that is unacceptable in otologic
applications [8].
[0009] The most common ear disorders of human being that require
surgical treatments are chronic serous otitis media (hereinafter
"CSOM") and cholesteatoma. The CSOM is characterized by
inflammation of the mucous membrane lining the middle ear that does
not respond to medical therapy. The cholesteatoma contains
keratinizing squamous epithelium (skin) trapped within the middle
ear cavity and leads to chronic infection, hearing loss, facial
nerve paralysis, and vertigo. Both the CSOM and cholesteatoma are
usually treated by an otologic surgery, for example, through a
mastoidectomy, to remove diseased tissues from the temporal bone
encasing the ear using a surgical drill and/or knife. As a result,
adjacent structures surrounding the surgical site of the temporal
bone, such as the facial nerve, the inner ear, the floor of the
cranial vault, the internal jugular vein and the carotid artery,
are at great risk during the surgical treatment.
[0010] It has been shown that IGS systems can improve overall
standards of surgical treatments in both neurosurgery and sinus
surgery. Specifically, IGS systems have improved surgical accuracy
and reduce the risk of major complications in sinus surgery [9],
and decreased operative time for neurosurgical procedures thus
cutting costs [10]. In addition, patients treated with an IGS have
more complete resection of diseased tissues with less collateral
damage to healthy tissues [11] than that treated with a traditional
surgery. It is anticipated that such advantages of the IGS systems
would be also applicable to an otologic surgery. Epidemiologic and
economic data supports the usefulness of an IGS in otologic
procedures. However, applications have been limited by the need for
millimeter and sub-millimeter accuracies to prevent injury to
adjacent structures, such as the facial nerve and the inner ear.
Therefore, a heretofore unaddressed need still exists in the art to
address the aforementioned deficiencies and inadequacies.
SUMMARY OF THE INVENTION
[0011] The present invention, in one aspect, relates to a system
for selectively disabling a surgical instrument operating in a
surgical site of a region of interest of a living subject, where
the surgical instrument has a distal end portion. The present
invention can be practiced with respect to several surgical
instruments and any combinations of them. As non-limiting examples,
the surgical instrument can be a drill, and the distal end portion
of the surgical instrument is the tip of the drill. The surgical
instrument can be a surgical scalpel, and the distal end portion of
the surgical instrument is the cutting portion of the surgical
scalpel. The surgical instrument can also be a suction device, and
the distal end portion of the surgical instrument is the sucking
portion of the suction device. The region of interest of the living
subject may correspond to an ear portion, a mouth portion, a head
portion, or other body portions of the living subject.
[0012] In one embodiment, the system includes means for
noninvasively placing a number, M, of fiducial markers in an
anatomic space of the region of interest of the living subject. The
placing means has a locking dental acrylic resin splint
(hereinafter "LADS") mountable to a maxilla of the living subject,
where the LADS includes a central portion with an extension at a
predetermined position, and two lateral portions attached to the
central portion. The placing means further has a fiducial frame
attachable to the LADS by the extension for receiving the number M
of fiducial markers. The fiducial frame comprises a frame
structure, a first panel and an opposite, second panel extending
upwardly from the frame structure, each of the first panel and the
second panel defining a number of holes for receiving a
corresponding number of fiducial markers. The fiducial frame is
configured such that when the number M of fiducial markers are
received therein, the centroid of each fiducial marker approximates
the surgical site of the ear portion of the living subject and
distance between at least one pair of two corresponding fiducial
markers is maximized so as to minimize a target registration
error.
[0013] The system further includes means for pre-operatively
measuring a location of each fiducial marker in the anatomic space
of the region of interest of the living subject, an imaging
acquisition device for pre-operatively acquiring an image volume
from the region of interest of the living subject, where the
pre-operatively acquired image volume includes the image of at
least two of M fiducial markers, and a probe operatively coupled
with the surgical instrument for intra-operatively monitoring a
location of the distal end portion of the surgical instrument in
the anatomic space of the region of interest of the living subject.
Moreover, the system includes a controller operatively coupled with
the measuring means, the imaging acquisition device, the probe, and
the surgical instrument, respectively. The controller is configured
to perform the steps of identifying a centroid of each fiducial
marker in the pre-operatively acquired image volume, registering
the identified centroid of each fiducial marker in the
pre-operatively acquired image volume to the pre-operatively
measured location of the corresponding fiducial marker in the
anatomic space so as to determine a registration transformation,
mapping the intra-operatively monitored location of the distal end
portion of the surgical instrument in the anatomic space onto a
corresponding location in the pre-operatively acquired image volume
by an inverse of the registration transformation, and generating a
signal to disable the surgical instrument when the mapped location
of the distal end portion of the surgical instrument is
substantially close to a boundary of the surgical site of the
region of interest in the pre-operatively acquired image volume.
Furthermore, the system includes a number, N, of surgical markers,
each placed in a surgically significant anatomic location serving
as a registration target.
[0014] Moreover, the system has an alarm device communicating with
the controller for generating an alarm when the mapped location of
the distal end portion of the surgical instrument is within a
predetermined distance to the boundary of the surgical site in the
region of interest in the pre-operatively acquired image volume.
Additionally, the system includes an interlock device operatively
associated with the surgical instrument and communicating with the
controller, where the interlock device disables the surgical
instrument when the mapped location of the distal end portion of
the surgical instrument is within a predetermined distance to the
boundary of the surgical site in the region of interest in the
pre-operatively acquired image volume.
[0015] In another aspect, the present invention relates to a method
for selectively disabling a surgical instrument operating in a
surgical site of a region of interest of a living subject, where
the surgical instrument has a distal end portion, the region of
interest of the living subject is surrounded with a plurality of
markers. The plurality of markers includes a number, M, of fiducial
markers determining an image registration and a number, N, of
surgical markers with each surgical marker placed in a surgically
significant anatomic location serving as a registration target. The
region of interest of the living subject corresponds to an ear
portion of the living subject.
[0016] In one embodiment, the method includes the step of
pre-operatively acquiring an image volume from the region of
interest of the living subject, where the pre-operatively acquired
image volume contains the image of at least two of M fiducial
markers. Furthermore, the method has the steps of identifying a
centroid of each fiducial marker from the pre-operatively acquired
image volume, pre-operatively measuring a location of each fiducial
marker in an anatomic space of the region of interest of the living
subject, registering the identified centroid of each fiducial
marker in the pre-operatively acquired image volume to the
pre-operatively measured location of the corresponding fiducial
marker in the anatomic space so as to determine a registration
transformation, intra-operatively monitoring a location of the
distal end portion of the surgical instrument in the anatomic space
of the region of interest of the living subject, and mapping the
intra-operatively monitored location of the distal end portion of
the surgical instrument in the anatomic space onto a corresponding
location in the pre-operatively acquired image volume by an inverse
of the registration transformation. Moreover, the method includes
the step of generating a signal to disable the surgical instrument
when the mapped location of the distal end portion of the surgical
instrument is substantially close to a boundary of the surgical
site of the region of interest of the living subject in the
pre-operatively acquired image volume.
[0017] In one embodiment, the method further has the step of
mounting an LADS with an attached fiducial frame onto a maxilla of
the living subject, where the fiducial frame is configured such
that when the number M of fiducial markers are received therein,
the centroid of each fiducial marker approximates the surgical site
of the ear portion of the living subject and distance between at
least one pair of two corresponding fiducial markers is maximized
so as to minimize a target registration error. Additionally, the
method has the step of generating an alarm when the mapped location
of the surgical instrument is within a predetermined distance to
the boundary of the surgical site in the pre-operatively acquired
image volume.
[0018] In yet another aspect, the present invention relates to a
system for selectively disabling a surgical instrument operating in
a surgical site of a region of interest of a living subject, where
the surgical instrument has a distal end portion and is operable by
a surgeon during a surgery. In one embodiment, the system has an
eye-tracking device operatively coupled with the surgical
instrument for intra-operatively tracking the visual line of sight
of the surgeon and a location of the distal end portion of the
surgical instrument in the region of interest of the living
subject, respectively, and a controller operatively coupled with
the surgical instrument and the eye-tracking device, respectively.
The controller is configured to perform during the surgery the
steps of determining an angle between a visual path connecting a
predetermined point of the eye-tracking device and the distal end
portion of the surgical instrument in the region of interest of the
living subject and the line of sight of the surgeon, and generating
a signal to disable the surgical instrument when the angle is
larger than a predetermined angle. In one embodiment, the
eye-tracking device includes a head-hold device and has a
sensor.
[0019] The system, in one embodiment, has a display communicating
with the controller and the eye-tracking device for displaying the
tracked line of sight of the surgeon and the tracked location of
the distal end portion of the surgical instrument in the region of
interest of the living subject, respectively.
[0020] In a further aspect, the present invention relates to a
method for selectively disabling a surgical instrument operating in
a surgical site of a region of interest of a living subject, where
the surgical instrument has a distal end portion and is operable by
a surgeon during a surgery. In one embodiment, the method includes
the steps of intra-operatively tracking the visual line of sight of
the surgeon and a location of the distal end portion of the
surgical instrument in the region of interest of the living
subject, respectively, determining an angle between a visual path
connecting a predetermined point of the eye-tracking device and the
distal end portion of the surgical instrument in the region of
interest of the living subject and the line of sight of the
surgeon, and generating a signal to disable the surgical instrument
when the angle is larger than a predetermined angle.
[0021] In yet a further aspect, the present invention relates to a
system for selectively disabling a surgical instrument operating in
a surgical site of a region of interest of a living subject, where
the surgical instrument has a distal end portion and is operable by
a surgeon during a surgery. In one embodiment, the system has a
probe for intra-operatively monitoring an electrophysiological
condition of the living subject in the region of interest, and a
controller operatively coupled with the surgical instrument and the
probe, respectively. The controller is configured to perform during
the surgery the steps of determining a variation of the
electrophysiological condition of the living subject from an
initial state of the living subject in the region of interest, and
generating a signal to disable the surgical instrument when the
variation of the electrophysiological condition is greater then a
predetermined value.
[0022] The system further has at least one of a display and an
audio device for visually and/or audibly displaying the
intra-operatively monitored electrophysiological condition of the
living subject in the region of interest, respectively.
[0023] In one embodiment, the probe comprises at least one needle
electrode placed in the region of interest of the living subject,
and the electrophysiological condition comprises an electromyogram
of electrical activities of muscles of the region of interest of
the living subject. In another embodiment, the probe comprises a
Doppler vascular probe, and the electrophysiological condition
includes a flow rate of blood vessels of the region of interest of
the living subject. In an alternative embodiment, the probe has a
temperature-sensing device, and the electrophysiological condition
includes a temperature of tissues of the region of interest of the
living subject. In one embodiment, the probe has an oxygenation
detector, and the electrophysiological condition comprises a venous
oxygenation saturation and an arterial oxygenation saturation of
the region of interest of the living subject. In another
embodiment, the probe includes a tissue boundary detector, where
the tissue boundary detector comprises at least one of an
ultrasound sensing device, an infrared radiation sensing device, an
ultraviolet radiation sensing device, a fluorescent radiation
sensing device, and a video frame device. The electrophysiological
condition includes a tissue type identification of tissues at the
distal end portion of the surgical instrument in the region of
interest of the living subject. The electrophysiological condition
may also relate to a volume of suction from the region of interest
of the living subject.
[0024] In one aspect, the present invention relates to a method for
selectively disabling a surgical instrument operating in a surgical
site of a region of interest of a living subject, where the
surgical instrument has a distal end portion and is operable by a
surgeon during a surgery. In one embodiment, the method includes
the steps of intra-operatively monitoring the electrophysiological
condition of the living subject in the region of interest,
determining a variation of the electrophysiological condition of
the living subject from an initial state of the living subject in
the region of interest, and generating a signal to disable the
surgical instrument when the variation of the electrophysiological
condition is greater than a predetermined value.
[0025] These and other aspects of the present invention will become
apparent from the following description of the preferred embodiment
taken in conjunction with the following drawings, although
variations and modifications therein may be affected without
departing from the spirit and scope of the novel concepts of the
disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 shows a perspective view of a LADS according to one
embodiment of the present invention: (A) the LADS dismissed, and
(B) the LADS mounted to a maxilla of a human anatomy.
[0027] FIG. 2 shows a perspective view of a fiducial frame: (A) the
fiducial frame according to one embodiment of the present
invention, (B) the fiducial frame according to another embodiment,
and (C) the fiducial frame according to an alternative
embodiment.
[0028] FIG. 3 shows a perspective view of placing means including a
LADS and a fiducial frame mounted to a skull of a human anatomy
according to one embodiment of the present invention: (A) a side
perspective view, and (B) a front perspective view.
[0029] FIG. 4 shows a flowchart for selectively disabling a
surgical instrument operating in a surgical site of a region of
interest of a living subject according to one embodiment of the
present invention.
[0030] FIG. 5 shows schematically a system for selectively
disabling a surgical instrument operating in a surgical site of a
region of interest of a living subject according to one embodiment
of the present invention.
[0031] FIG. 6 shows schematically a block diagram for a system for
selectively disabling a surgical instrument operating in a surgical
target of a living subject according to one embodiment of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0032] The present invention is more particularly described in the
following examples that are intended as illustrative only since
numerous modifications and variations therein will be apparent to
those skilled in the art. Various embodiments of the invention are
now described in detail. Referring to the drawings, like numbers
indicate like parts throughout the views. As used in the
description herein and throughout the claims that follow, the
meaning of "a," "an," and "the" includes plural reference unless
the context clearly dictates otherwise. Also, as used in the
description herein and throughout the claims that follow, the
meaning of "in" includes "in" and "on" unless the context clearly
dictates otherwise.
[0033] The description will be made as to the embodiments of the
present invention in conjunction with the accompanying drawings
1-6. In accordance with the purposes of this invention, as embodied
and broadly described herein, this invention, in one aspect,
relates to a system for selectively disabling a surgical instrument
operating in a surgical site of a region of interest of a living
subject. The living subject can be a human patient or an animal. In
one embodiment, a human patient is employed to practice the current
invention, a region of interest of the patient corresponds to an
ear portion of the patient, and the surgical instrument having a
distal end portion and is operable by a surgeon during a
surgery.
[0034] Referring first to FIG. 6, a block diagram for a system 600
is schematically shown. In general, the system 600 can be utilized
by at least one surgical professional 610 for operating a surgery
on a surgical target, which may includes pre-operatively surgery
planning, intra-operatively surgery operation and post-operatively
surgery evaluation. The system 600 includes a surgical instrument
620 operable by the at least one surgical professional 610 for
operating the surgery with respect to the surgical target 630. The
system 600 further has a detector 640 communicatable with the at
least one surgical professional 610, the surgical instrument 620
and the surgical target 630, for intra-operatively detecting a
visual condition of the surgical professional 610, a location of
the surgical instrument 620, and an electrophysiological condition
of the surgical target 630, respectively. Moreover, the system 600
has a controller 650 communicating with the detector 640, and the
surgical instrument 620, respectively, for receiving data from the
detector 640, processing them therein and generating a signal to
disable the surgical instrument 620 when a predetermined condition
in the processed data is identified, as further described below.
The controller 650 is programmable by the surgical professional 610
or other authorized users such as surgical assistants. Furthermore,
the system 600 includes a display 660 communicatable with the
controller 650 for intra-operatively displaying the detected visual
condition of sight of the at least one surgical professional 610,
the location of the surgical instrument 620, and the
electrophysiological condition of the living subject in the
surgical target 630, respectively. The information on the display
660 is available to the at least one surgical professional 610 or
surgical assistants.
[0035] Specifically, the system, in one embodiment, includes means
for noninvasively placing a number, M, of fiducial markers in an
anatomic space of the ear portion of a patient. Referring in
general to FIGS. 1-3, and in particular to FIG. 1, the placing
means includes a LADS 100 (Peterman Dental Lab, Nashville, Tenn.)
that is mounted onto a maxilla 180 of the patient. The LADS 100 is
in the form of a dental bite-block that may be customizedly molded
for individual maxillary dental patterns. The LADS 100 has a
central portion 110 that imprints the lingual and occlusal surfaces
of the maxillary teeth with an extension 120 at a predetermined
position 130 and two lateral portions 140a and 140b that imprint
the buccal surfaces and are attached to the central portion 110,
respectively. The extension 120 has mounting means 125, which in
this embodiment has one or more mounting holes formed on the
extension 120. The central portion 110 and lateral portions 140a
and 140b are secured onto the maxilla 180 using one or more screws
150 that hold the lateral portions 140a and 140b securely with the
central portion 110 in cooperation with corresponding mounting
holes 125. The geometry of the teeth, being narrower at the
insertion into the gums, ensures a tight, reliable fit.
[0036] The placing means further includes a fiducial frame that is
attached to the LADS by the extension for receiving the number M of
fiducial markers. Referring now to FIG. 2A, in one embodiment, a
fiducial frame 200a includes a U-shaped frame structure 210 having
a first end portion 216a and a second end portion 216b, a first
panel 220a extending upwardly from the first end portion 216a of
the frame structure 210, and an opposite, second panel 220b
extending upwardly from the second end portion 216b of the frame
structure 210. Each of the first panel 220a and the second panel
220b has one or more holes formed therein for receiving
corresponding marker(s) 225. In one embodiment, commercially
available markers 225 (Acustar.RTM., Z-Kat, Inc., Hollywood, Fla.)
are received into the holes and mounted on the first panel 220a and
the second panel 220b of the fiducial frame 200a, respectively. The
fiducial frame 200a further has an engagement projection 215
located at a predetermined position in the frame structure 210 for
engaging the fiducial frame 200a to the LADS 100 through
corresponding mounting means 125.
[0037] Referring to FIG. 2B, a fiducial frame 200b is shown
according to another embodiment of the present invention. The
fiducial frame 200b has a frame structure 240. The frame structure
240 includes a first arm 244a, a second arm 244b, a shoulder 242
connecting the first arm 244a and the second arm 244b, a first
adjusting means 243a located in the junction of the shoulder 242
and the first arm 244a, and a second adjusting means 243b located
in the junction of the shoulder 242 and the second arm 243b. The
first arm 244a has an end portion 246a, and the second arm 244b has
an end portion 246b. The fiducial frame 200b further has a first
panel 250a and an opposite, second panels 250b respectively
extending upwardly from the end portions 246a and 246b of the first
arm 244a and the second arm 244b of the frame structure 240. Each
of the first panel 250a and the second panel 250b is structured to
receive several corresponding fiducial markers 255. The fiducial
frame 200b further has an engagement projection 245 located at a
predetermined position in the shoulder 242 of the frame structure
210 for engaging the fiducial frame 200b to the LADS 100 through
corresponding mounting means 125. In this embodiment, the size of
the fiducial frame 200b can be adjusted by the adjusting means 243a
and 243b to accommodate skulls of varying dimensions of a living
subject.
[0038] FIG. 2C shows a fiducial frame 200c according to an
alternative embodiment of the present invention. The fiducial frame
200c includes a frame structure 270 that has a shoulder 272, a
first arm 274a and a second arm 274b extending from the shoulder
272, respectively. The first arm 274a has an end portion 276a, and
the second arm 274b has an end portion 276b. The fiducial frame
200c further has a first panel 280a and an opposite, second panels
280b respectively extending upwardly from the end portions 276a and
276b of the first arm 274a and the second arm 274b of the frame
structure 270. Each of the first panel 280a and the second panel
280b is structured to receive several corresponding fiducial
markers 285. The fiducial frame 200c further has an engagement
projection 275 located at a predetermined position in the shoulder
272 of the frame structure 270 for engaging the fiducial frame 200c
to the LADS 100 through corresponding mounting means 125. The
fiducial frame 200c is featured at minimizing weight and optimizing
the number of fiducial markers necessary to achieve sub-millimeter
accuracy.
[0039] A fiducial frame is made of materials such that the fiducial
frame is considered as a rigid-body, i.e., no appreciable deformity
under normal use, and has a weight minimized so as to prevent
excess torques that may injure dentition. In one embodiment, spun
carbon fibers are used to construct the fiducial frame, which
minimize weight while maximizing rigidity of the fiducial
frame.
[0040] Referring to FIGS. 3A and 3B, a placing means 300 is secured
to a skull 390 of a human by mounting a LADS 350 onto the maxilla.
In this embodiment, a fiducial frame 310 shown in FIG. 2C is
attached to the LADS 350 by mounting means 355.
[0041] The fiducial frame 310 is configured such that when a number
of fiducial markers 325 are received in the first panel 320a and
the second panel 320b, respectively, the centroid of each fiducial
marker 325 approximates a predetermined surgical site 380 in the
ear portion 370 of the human and the distance between the
corresponding fiducial markers 325 positioned in each of the first
panel 320a and the second panel 320b is maximized so as to minimize
a TRE. Rigid fixation of fiducial markers to the first panel 320a
and the second panel 320b is advantageous because it avoids
drilling into the skull. In one embodiment, nine fiducial markers,
such as Acustar.RTM. of Z-Kat, Inc., are received in each of the
first panel 320a and the second panel 320b of the fiducial frame
310. The eighteen markers are served as fiducial markers for
registration.
[0042] Furthermore, the system includes an image acquisition device
(not shown), such as a CT imaging scanner or a MR imaging scanner,
for pre-operatively acquiring an image volume, i.e., a
three-dimensional (hereinafter "3D") radiographic image, which
contains the eighteen fiducial markers from the ear portion of the
patient. In one embodiment, the image volume, such a CT image, is
acquired using clinically applicable, temporal-bone algorithms with
scan thickness of about 0.5 mm. Moreover, the system includes means
for pre-operatively measuring a location of each fiducial marker in
the anatomic space of the ear potion of the patient. In one
embodiment, a commercially available infrared optical tracking
system (Polaris.RTM., Northern Digital Corp., Waterloo, Canada) is
employed to measure the location of each fiducial marker in the
anatomic space of the ear potion of the patient. Other tracking
systems can also be used to practice the current invention. The
system further includes a surgical probe operatively coupled with
the surgical instrument to detect a location of the distal end
portion of the surgical instrument in anatomic space of the ear
portion of the patient during the surgical treatment. In one
embodiment, the surgical probe comprises an infrared optical
tracking system, and the surgical instrument includes a high-speed
surgical drill fitted with infrared emitters that is visible to the
infrared optical tracking system.
[0043] Additionally, the system includes a controller operatively
coupled with the image acquisition device, the measuring means and
the surgical probe, respectively.
[0044] The controller in one embodiment includes a computer and is
configured to (i) identify a centroid of each fiducial marker in
the pre-operatively acquired 3D radiographic image, for example, a
CT image volume, (ii) register the identified centroid of each
fiducial marker in the pre-operatively acquired 3D radiographic
image to the pre-operatively measured location of the corresponding
fiducial marker in the anatomic space so as to determine a
registration transformation, (iii) map the intra-operatively
monitored location of the distal end portion of the surgical
instrument in the anatomic space onto a corresponding location in
the pre-operatively acquired 3D radiographic image by an inverse of
the registration transformation, and (iv) generate a signal to
disable the surgical instrument when the mapped location of the
distal end portion of the surgical instrument is substantially
close to a boundary of the surgical site of the region of interest
in the pre-operatively acquired 3D radiographic image.
[0045] In one embodiment, the system also includes an interlock
device operatively associated with the surgical instrument and
communicating with the controller. The interlock device in one
embodiment includes an articulated/robotic arm that is programmed
to control the surgical instrument to perform mastoidectomies based
on pre-operative CT scans which have contoured to indicate desired
surgical excavation, and disable the surgical instrument when the
mapped location of the distal end portion of the surgical
instrument is within a predetermined distance to the boundary of
the surgical site in the region of interest in the pre-operatively
acquired image volume. In one embodiment, the predetermined
distance to the boundary of the surgical site is about 0.5 mm.
[0046] The system further includes an audio alarm coupled with the
controller for generating an alarm when the mapped location of the
surgical instrument is within a predetermined distance to the
boundary of the surgical site in the acquired 3D radiographic image
and a video frame coupled with the controller for displaying the
precise anatomic location of the transgression as feedback to the
operator.
[0047] Additionally, the system in one embodiment has two markers
placed at surgically significant anatomic locations: the internal
auditory canal and stylomastoid foramen of the ear portion of the
patient, respectively. These two markers served as surgical targets
for the purpose of estimating target registration error. Other
anatomic landmarks which are stable and repeatably identifiable
both on CT imaging scans and within the OR can also serve as
surgical targets. They are any and/or all of the following: (i) the
spine of Henle--a small outcrop of bone in the lateral external
auditory canal, (ii) the lambda suture--a junction of three boney
plates visible on the surface on the skull behind the ear, (iii)
the capitulum of the stapes--the top portion of the third ear bone,
(iv) the cochleaform process--a small outcropping of bone into
which a tendon, the tensor tympani, attaches, (v) the pyramidal
process--another small outcropping of bone into which a tendon, the
stapedial, tendon attaches, (vi) the midpoint of the subiculum--a
boney ridge which separates the oval window and the round window,
and (vii) the neck of the malleus, a relatively constant position
of the first ear bone.
[0048] The registration between the anatomic space and the CT image
space is performed using various subsets of the fiducial markers.
Each resulting transformation is applied to each surgical target
marker in the anatomic space. The disparity between the transformed
position and the measured position in the CT image space serves as
a measure of registration error. Geometric arrangement of fiducial
markers and their relation to target position affects error as
expected from previous theoretical predictions [12]. Specifically,
target registration errors are minimized with arrangement of the
fiducial markers surrounding the surgical site of interest such
that the centroid of the fiducial markers approximates the surgical
site of interest. Also, registration accuracy is improved with the
number of fiducial markers but with diminishing returns over a
critical number. This becomes important in high-resolution CT
scanning with the scannable volume is finite thus limiting the
feasible number of markers. In one embodiment, with all 18 fiducial
markers used for registration, that is each side of the ear portion
of the patent has 9 fiducial markers, which are received in a first
panel and a second panel of a fiducial frame, respectively, TRE for
the surgically significant anatomic locations including an internal
auditory canal and a stylomastoid foramen are TRE1=0.41 mm and
TRE2=0.90 mm, respectively. In another embodiment, surrounding the
side of interest, where a surgical site is located, of the ear
portion of the patent with 9 markers and balancing this with a
single, centrally placed marker on the contralateral side of the
ear portion of the patient produces similar results with TRE1=0.52
mm and TRE2=0.90 mm. However, for an inverse situation, that is,
surrounding the contralateral side of the surgical site of the ear
portion of the patient with 9 fiducial markers and balancing the
side of the surgical site of the ear portion of the patient with a
single marker, it produces worse results with TRE1=1.26 mm and
TRE2=1.80 mm for the internal auditory canal and stylomastoid
foramen targets, respectively. These are the largest registration
target errors occurred among 17 different configurations of 18
fiducial markers. TREs with a sub-millimeter accuracy (<1 mm)
are reproducibly achievable using 5 fiducial markers surrounding
the side of the surgical site of the ear portion of the patient and
a single, centrally located fiducial marker balancing on the
contralateral side of the ear potion of the patient for a critical
number of 6 total fiducial markers. This makes image guided
otologic surgery with submillimeter accuracy achievable with a
minimally invasive fiducial frame.
[0049] The present invention, in another aspect, relates to a
method for selectively disabling a surgical instrument operating in
a surgical site of a region of interest of a patient thereof
responsive to a position feedback of the surgical instrument that
has a distal end portion. For example, the surgical instrument can
be a surgical drill, a surgical scalpel and/or a suction device
operable by a surgeon during surgery such as an otologic surgery to
a human patient, and the region of interest of the patient
corresponds to an ear portion of the patient. Prior to the otologic
surgery, an Institutional Review Board (Vanderbilt University,
Nashville, Tenn.) approval for surgical procedures of the otologic
surgery for human patients is obtained and patient consent for the
otologic surgery is acquired. A patient-specified LADS is
constructed in a dental lab, for example, Peterman Dental Lab,
after maxillary impressions are taken from the patient. The
patient-specified LADS is then attached to a fiducial frame and
mounted onto the maxilla of the patient, where the fiducial frame
is configured such that when the number M of fiducial markers are
received therein, the centroid of each fiducial marker approximates
the surgical site of the ear portion of the patient and distance
between two corresponding fiducial markers is maximized so as to
minimize a target registration error. In one embodiment, each side
of the ear portion of the patient is surrounded with nine fiducial
markers. In addition, two surgical markers are placed in close
proximity to 2 anatomically important structures, such as an
internal auditory canal and a stylomastoid foramen of the ear
portion of the patient.
[0050] In one embodiment, the method, as shown in FIG. 4, includes
the following steps: at step 410, an image volume is acquired
pre-operatively from the ear portion of the patient, where the
pre-operatively acquired image volume contains the image of at
least two of M fiducial markers. In one embodiment, three
sequential CT imaging scans from the ear portion of the patient
wearing the LADS and fiducial frame are taken. Other numbers of
sequential CT imaging scans can also be taken. The fiducial frame
is removed from and reattached to the LADS between two CT imaging
scans. Multiple CT imaging scans are necessary in determining
fiducial registration error (hereinafter "FRE") of the image space,
which is employed to determine TRE. These FREs are averaged using
sum of squares to determine an average FRE. At step 420, a centroid
of each fiducial marker is identified from the pre-operatively
acquired image volume. In one embodiment, the image volumes (3D CT
images) are reconstructed from the CT imaging scans by utilizing a
high-performance computer. On these reconstructed image volumes,
voxels (i.e., a surgical site) that lie within the ear portion of
the patient are selected by the surgeon. In other words, a surgical
excavation, i.e., a mastoidectomy, is pre-operatively planned based
on the radiographic images.
[0051] After pre-operatively acquiring image volumes of the
patient, the LADS and the fiducial frame are removed and saved for
the patient. In the OR, after performing a general anesthesia, the
patient is re-fitted with his/her customized LADS and the fiducial
frame. A location of each fiducial marker in an anatomic space of
the ear portion of the patient is measured using an infrared
optical tracking system, such as Polaris.RTM., at step 430. The
identified centroid of each fiducial marker in the pre-operatively
acquired image volume is registered to the pre-operatively measured
location of the corresponding fiducial marker in the anatomic space
at step 440. The image registration determines a registration
transformation and is performed by a computer in conjunction with
the infrared optical tracking system and customized software. The
registration transformation, in one embodiment, includes a
rigid-body transformation. During the surgery, a location of the
distal end portion of the surgical instrument in the anatomic space
of the ear portion of the patient is monitored at step 450. In one
embodiment, a high-speed surgical drill fitted with IR emitters is
employed for the otologic surgery, and its tip location of the
surgical drill is monitored by the infrared optical tracking
system. At step 460, the intra-operatively monitored location of
the distal end portion of the surgical instrument in the anatomic
space is mapped onto a corresponding location in the
pre-operatively acquired image volume by an inverse of the
registration transformation. The mapping step in one embodiment is
performed with the computer. When the mapped location of the
surgical instrument is within a predetermined distance to the
boundary of the surgical site in the pre-operatively acquired image
volume, a controller, such as a computer coupled with the surgical
instrument, generates a signal to disable the surgical instrument
at step 470. In one embodiment, the predetermined distance is about
0.5 mm. Software codes and electric circuits for controlling the
surgical instrument in the present invention are custom-designed.
In the present invention, among other things, unique to the
otologic surgery is that the surgical instrument, a high-speed
surgical drill, can be quickly disabled to prevent collateral
damage to healthy tissues. The disablement includes simply turning
off the rotation of the bit using active braking when the surgical
instrument leaves the surgeon-identified surgical site.
[0052] According to one embodiment of the current invention,
anatomically significant landmarks, as described above, are
intra-operatively and post-operatively acquired, respectively, in a
blinded fashion, i.e., the surgeon points to a structure and an
assistant acquires its position and label it. These data points are
used to analyze the TRE of these anatomically significant
points.
[0053] In addition, three endpoints of the surgery including (i)
number of surgical transgressions beyond the safe surgical field,
(ii) volume of tissues removed, and (iii) time of the surgery, are
measured. Endpoint (i) is corresponding to an index of safety of
the surgery and measured during the otologic surgery. Endpoint (ii)
is assessed by obtaining post-surgical CT imaging scans to
determine what percentage of the original planned excavation
occurred. And endpoint (iii) corresponds to the operating time of
the surgery from the start to the end of the surgery. Endpoints (i)
and (iii) are corresponding to indices of efficiency of the
surgery. Statistically appropriate comparisons are made after
determining the distribution of the indices of efficiency of the
surgery. Analysis of the endpoint data is performed with
SigmaStat.RTM. Statistical Software (SPSS Science, Inc., Chicago,
Ill.).
[0054] Referring now to FIG. 5, a system 500 has a surgical
instrument 520 operating in a surgical site 530 of a region of
interest of a patient. The surgical instrument 520 has a distal end
portion 522 and is operable by a surgeon 510 during a surgery. The
surgical instrument 520 may be a commercially available surgical
drill, a surgical scalpel, a suction device such as a surgical pump
or tube, or other surgical instruments and any combination of them.
The system 500 further has an eye-tracking device 540 for
intra-operatively tracking the visual line of sight 570 of the
surgeon 510 and a location of the distal end portion 522 of the
surgical instrument 520 in the region of interest of the patient,
respectively. In one embodiment, the eye-tracking device 540
includes a head-hold device, such as EyeLink.RTM. II, (SR Research,
Ltd., Osgoode, Canada). Other eye-tracking devices can also be
employed to practice the current invention. The system 500 also
includes a controller 550 that is operatively coupled with the
surgical instrument 520 and the eye-tracking device 540,
respectively. The controller 550, such as a computer, is configured
to perform during the surgery the step of processing the
intra-operatively tracked visual line of sight 570 of the surgeon
510 and the location of the distal end portion 522 of the surgical
instrument 520 in the region of interest of the patient to
determine an angle, .alpha., between a visual path 580 connecting a
predetermined point 542 of the eye-tracking device 540 and the
distal end portion 522 of the surgical instrument 520 in the region
of interest of the patient and the line of sight 570 of the surgeon
510. The controller 550 is further configured to perform the step
of generating a signal to disable the surgical instrument 520 when
the angle a is larger than a predetermined angle as a threshold. In
one embodiment, the controller 550 is associated with a
computer.
[0055] In one embodiment, the system 500 has a display 560
communicatable with the controller 550 and the eye-tracking device
540 for displaying the tracked line of sight 570 of the surgeon 510
and the tracked location of the distal end portion 522 of the
surgical instrument 520 in the region of interest of the patient,
respectively.
[0056] The present invention, in one aspect, relates to a system
for selectively disabling a surgical instrument operating in a
surgical site of a region of interest of a patient, where the
surgical instrument has a distal end portion and is operable by a
surgeon during a surgery. In one embodiment, the system has a probe
adapted for intra-operatively monitoring an electrophysiological
condition of the patient in the region of interest, and a
controller that is operatively coupled with the surgical instrument
and the probe, respectively. The controller is further configured
to perform during the surgery the steps of processing the
intra-operatively monitored electrophysiological condition of the
patient in the region of interest to identify a variation of the
electrophysiological condition from an initial state of the patient
in the region of interest, and generating a signal to disable the
surgical instrument when the variation of the electrophysiological
condition of the patient in the region of interest is greater than
a predetermined value. The controller is associated with a
computer.
[0057] In one embodiment, the probe has at least one needle
electrode placed in the region of interest of the patent adapted
for intra-operatively recording an electromyogram of electrical
activities of muscles of the region of interest of the patient.
When a myogenic potential is recorded by the at least one needle
electrode, the controller will generate a signal to disable the
surgical instrument.
[0058] The probe in another embodiment has a Doppler vascular probe
adapted for intra-operatively monitoring a flow rate of blood
vessels of the region of interest of the patient. When a variation
of the flow rate of blood vessels of the region of interest of the
patient is greater than a predetermined value, the controller will
generate a signal to disable the surgical instrument.
[0059] In yet another embodiment, the probe has a
temperature-sensing device adapted for intra-operatively measuring
a temperature of tissues of the region of interest of the patient.
When a variation of the tissue temperature of the region of
interest of the patient is greater than a predetermined value, the
controller will generate a signal to disable the surgical
instrument.
[0060] In an alternative embodiment, the probe has an oxygenation
detector adapted for intra-operatively detecting a venous
oxygenation saturation and an arterial oxygenation saturation of
the region of interest of the patient intra-operatively monitored
by the oxygenation detector. When an alteration of the venous
oxygenation saturation versus the arterial oxygenation saturation
of the region of interest of the patient is identified, the
controller will generate a signal to disable the surgical
instrument.
[0061] The probe, in one embodiment, has a tissue boundary
detector, where the tissue boundary detector includes at least one
of an ultrasound sensing device, an infrared radiation sensing
device, an ultraviolet radiation sensing device, a fluorescent
radiation sensing device, and a video frame device. The tissue
boundary detector is adapted for intra-operatively identifying a
tissue type of tissues at the distal end portion of the surgical
instrument in the region of interest of the patient. When the
tissue type of tissues at the distal end portion of the surgical
instrument is changed, the controller will generate a signal to
disable the surgical instrument.
[0062] The present invention, among other things, discloses a
system and method for selectively disabling a surgical instrument
operating in a surgical site of a region of interest of a living
subject, in response to a position feedback of the surgical
instrument, an electrophysiological condition of the living subject
in a region of interest, and a visual condition of sight of a
surgeon who operates a surgery, respectively.
[0063] The foregoing description of the exemplary embodiments of
the invention has been presented only for the purposes of
illustration and description and is not intended to be exhaustive
or to limit the invention to the precise forms disclosed. Many
modifications and variations are possible in light of the above
teaching.
[0064] The embodiments were chosen and described in order to
explain the principles of the invention and their practical
application so as to enable others skilled in the art to utilize
the invention and various embodiments and with various
modifications as are suited to the particular use contemplated.
Alternative embodiments will become apparent to those skilled in
the art to which the present invention pertains without departing
from its spirit and scope. Accordingly, the scope of the present
invention is defined by the appended claims rather than the
foregoing description and the exemplary embodiments described
therein.
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