U.S. patent application number 13/932428 was filed with the patent office on 2013-11-07 for method, apparatuses, and systems useful in conducting image guided interventions.
The applicant listed for this patent is Veran Medical Technologies, Inc.. Invention is credited to Jerome R. EDWARDS.
Application Number | 20130296690 13/932428 |
Document ID | / |
Family ID | 34138831 |
Filed Date | 2013-11-07 |
United States Patent
Application |
20130296690 |
Kind Code |
A1 |
EDWARDS; Jerome R. |
November 7, 2013 |
METHOD, APPARATUSES, AND SYSTEMS USEFUL IN CONDUCTING IMAGE GUIDED
INTERVENTIONS
Abstract
Methods, apparatuses, and systems relating to image guided
interventions on dynamic tissue. One embodiment is a method that
includes creating a dataset that includes images, one of the images
depicting a non-tissue internal reference marker, being linked to
non-tissue internal reference marker positional information, and
being at least 2-dimensional. Another embodiment is a method that
includes receiving a position of an instrument reference marker
coupled to an instrument; transforming the position into image
space using a position of a non-tissue internal reference marker
implanted in a patient; and superimposing a representation of the
instrument on an image in which the non-tissue internal reference
marker appears. Computer readable media that include machine
readable instructions for carrying out the steps of the disclosed
methods. Apparatuses, such as integrated circuits, configured to
carry out the steps of the disclosed methods. Systems that include
devices configured to carry out steps of the disclosed methods.
Inventors: |
EDWARDS; Jerome R.;
(Nashville, TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Veran Medical Technologies, Inc. |
St. Louis |
MO |
US |
|
|
Family ID: |
34138831 |
Appl. No.: |
13/932428 |
Filed: |
July 1, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12941555 |
Nov 8, 2010 |
8483801 |
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13932428 |
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12146738 |
Jun 26, 2008 |
7853307 |
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12941555 |
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10649600 |
Aug 26, 2003 |
7398116 |
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12146738 |
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60494268 |
Aug 11, 2003 |
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Current U.S.
Class: |
600/414 ;
600/424 |
Current CPC
Class: |
A61B 2576/00 20130101;
A61B 34/10 20160201; A61B 90/36 20160201; A61B 2034/2051 20160201;
A61B 6/12 20130101; A61B 2034/2072 20160201; A61B 34/20 20160201;
A61B 5/055 20130101; A61B 2090/3958 20160201; A61B 5/7289 20130101;
A61B 2017/00694 20130101; A61B 6/541 20130101; A61B 2090/3954
20160201 |
Class at
Publication: |
600/414 ;
600/424 |
International
Class: |
A61B 19/00 20060101
A61B019/00 |
Claims
1. A method comprising: creating a dataset that includes images,
one of the images (a) depicting a non-tissue internal reference
marker, (b) being linked to non-tissue internal reference marker
positional information, and (c) being at least 2-dimensional.
2. The method of claim 1, where the non-tissue internal reference
marker positional information comprises a dataset vector
3.-7. (canceled)
8. The method of claim 2, further comprising: loading a gated
dataset into memory, the gated data set including the images, one
of the images (a) depicting the non-tissue internal reference
marker, and (b) being linked to a sample of a first periodic human
characteristic signal.
9. The method of claim 8, where each image (a) depicts the
non-tissue internal reference marker, and (b) is linked to a sample
of a first periodic human characteristic signal.
10. The method of claim 8, further comprising: receiving a second
periodic human characteristic signal; and comparing a sample of the
second periodic human characteristic signal to the sample of the
first periodic human characteristic signal.
11. The method of claim 10, where the first and second periodic
human characteristic signals are electrocardiogram (ECG)
signals.
12. The method of claim 10, further comprising: recognizing a
sample of the second periodic human characteristic signal that
matches the sample of the first periodic human characteristic
signal; and receiving (a) a position of an external reference
marker and (b) a position of the non-tissue internal reference
marker.
13. The method of claim 12, further comprising: calculating the
dataset vector using (a) the position of the external reference
marker and (b) the position of the non-tissue internal reference
marker.
14.-23. (canceled)
24. A method comprising: receiving a position of an instrument
reference marker coupled to an instrument; transforming the
position into image space using a position of a non-tissue internal
reference marker implanted in a patient; and superimposing a
representation of the instrument on an image in which the
non-tissue internal reference marker appears.
25. The method of claim 24, where the image was taken using
fluoroscopy.
26. The method of claim 24, where the image was taken using
computed tomography (CT).
27. The method of claim 24, where the image was taken using
magnetic resonance imaging (MRI).
28. The method of claim 24, where the transforming includes
transforming the position into image space using a transformation
that is based, in part, on the position of the non-tissue internal
reference marker implanted in the patient.
29. The method of claim 28, further comprising: calculating the
transformation using image space coordinates of the internal
reference marker in the image.
30. The method of claim 29, further comprising: linking the
transformation to the image.
31. The method of claim 30, further comprising: loading the
transformation into memory.
32. The method of claim 24, further comprising: receiving an image
signal that includes the image.
33. The method of claim 32, further comprising: receiving a
position of the non-tissue internal reference marker in the
image.
34. The method of claim 33, further comprising: calculating a
vector using the position
35. The method of claim 34, further comprising: linking the vector
with the image.
36. The method of claim 35, where the transforming includes
transforming the position into image space using a transformation
that is based, in part, on the position of the non-tissue internal
reference marker implanted in the patient.
37. The method of claim 36, further comprising: linking the
transformation from tracking space to image space with the
image.
38. A computer readable medium comprising machine readable
instructions for carrying out the steps of claim 24.
39. A method comprising: receiving an image signal that includes
images, each image depicting a non-tissue internal reference
marker; receiving a position of the non-tissue internal reference
marker in one of the images (image I1); calculating a vector using
the position; linking the vector with an image I1; linking a
transformation from tracking space to image space with image I1;
receiving a current position of an instrument reference marker
coupled to an instrument; applying the transformation to the
current position of the instrument reference marker; and
superimposing a representation of the instrument on image I1.
40. A computer readable medium comprising machine readable
instructions for carrying out the steps of claim 39.
Description
CROSS-REFERENCE(S) TO RELATED APPLICATION(S)
[0001] This application claims priority to U.S. Provisional Patent
Application Ser. No. ______, filed Aug. 11, 2003 by Jerome R.
Edwards, entitled "METHODS, APPARATUSES, AND SYSTEMS USEFUL IN
CONDUCTING IMAGE GUIDED INTERVENTIONS," the entire contents of
which are expressly incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention is directed generally to computer
readable media, apparatuses, systems, and methods that concern
image guided medical procedures.
[0004] 2. Description of Related Art
[0005] Image guided surgery (IGS), also known as image guided
intervention (IGI), has become an established and proven technology
field that enhances a physician's understanding of the location of
his instruments within anatomy during therapy delivery. IGI has
grown to include 2-dimensional (2-D) and 3-dimensional (3-D)
applications. Virtual fluoroscopy as described in U.S. Pat. No.
6,470,207, Navigational Guidance via Computer Assisted Fluoroscopic
Imaging, Simon et al., which is expressly incorporated by
reference, discloses how to register the coordinate system of
anatomy in a live operating theatre to that of a 2-D fluoroscopic
image and then superimpose the real-time movements of instruments
on that image as icons. U.S. Pat. No. 6,490,467, Surgical
Navigation Systems Including Reference and Localization Frames,
Bucholz et al., which is also expressly incorporated by reference,
discloses how to register the coordinate system of anatomy in a
live operating theatre to that of a 3-D magnetic resonance imaging
(MRI) or computed tomography (CT) image volume and then superimpose
the real-time movements of instruments on that image volume as
icons. The techniques disclosed in these patents combined with
other state of the art technologies have worked well in procedures
involving static anatomy. Static anatomy is anatomy that does not
move or has very minimal movement with respect to heart beat and
respiration, such as the sinuses, long bones, brain, and individual
vertebral bodies of the spine. The use of image guidance is fast
approaching the standard of care in neurosurgical tumor resection,
spinal implant placement, ear-nose-and-throat (ENT) surgery, and
orthopedics.
[0006] However, IGI has not made significant inroads into medical
procedures involving dynamic anatomy. Dynamic anatomy is anatomy
that moves significantly with respect to heart beat and
respiration, such as the heart, lungs, kidneys, liver, and blood
vessels. IGI to date is limited mostly to use in static anatomy
medical procedures primarily due to its usage of static imaging
modalities such as single frame fluoroscopy, and single volume MRI
and CT.
[0007] Imaging modalities do exist to capture dynamic anatomy.
Modalities such as electrocardiogram (ECG)-gated MRI, ECG-gated CT
and cinematography (CINE) fluoroscopy (e.g., looped CINE
fluoroscopy) are readily available in hospitals worldwide. These
dynamic imaging modalities can capture anatomy over an entire
periodic cycle of movement by sampling the anatomy at several
instances during its characteristic movement and then creating a
set of image frames or volumes. The use of dynamic imaging
modalities in IGI will allow IGI to transcend the boundaries of
static anatomy and administer efficacy benefits to even more
medical procedures.
[0008] U.S. Pat. No. 6,473,635, A Method of and Device for
Determining the Position of A Medical Instrument, Rasche, which is
expressly incorporated by reference, proposes using the ECG
waveform emanating from a live patient in the operating theatre to
continuously select from a set of images that were gated to ECG
data. However, Rasche's proposal will not work when the patient
exhibits an irregular ECG pattern due to the medical therapies that
are being applied to him. Examples of induced ECG irregularity
would occur during pacemaker and implantable cardioverter
defibrillator lead placement and radiofrequency ablation of
myocytes to cure tachycardia.
SUMMARY OF THE INVENTION
[0009] One embodiment is a method that includes creating a dataset
that includes images, at least one of those images depicting a
non-tissue internal reference marker, being linked to non-tissue
internal reference marker positional information, and being at
least 2-dimensional.
[0010] Another embodiment is a method that includes receiving a
position of an instrument reference marker coupled to an
instrument; transforming the position into image space using a
position of a non-tissue internal reference marker implanted in a
patient; and superimposing a representation of the instrument on an
image in which the non-tissue internal reference marker
appears.
[0011] Other embodiments of the present methods are disclosed
below.
[0012] Other embodiments include computer readable media that
include machine readable instructions for carrying out the steps of
any of the present methods. Still other embodiments include
apparatuses, such as integrated circuits, configured to carry out
the steps of any of the present methods. Other embodiments include
systems that include devices configured to carry out steps of the
present methods.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The following drawings demonstrate aspects of some of the
present methods, apparatuses, and systems. They illustrate by way
of example and not limitation. Like reference numbers refer to
similar elements.
[0014] FIG. 1 shows the layout of a system that may be used to
carry out image guided interventions using certain of the present
methods that involve gated datasets.
[0015] FIG. 2 is a representation of one of the present gated
datasets stored in memory.
[0016] FIG. 3 illustrates one example of samples of a periodic
human characteristic signal (specifically, an ECG waveform)
associated, or gated, with images of dynamic anatomy.
[0017] FIG. 4 is a flowchart showing an embodiment of a state
through which the present software may run to perform certain
embodiments of the present methods.
[0018] FIG. 5 is a flowchart showing another embodiment of a state
through which the present software may run to perform certain
embodiments of the present methods.
[0019] FIG. 6 shows the layout of a system that may be used to
carry out image guided interventions using certain of the present
methods that do not involve gated datasets.
[0020] FIG. 7 illustrates one example of the link between reference
marker positional information and images of dynamic anatomy.
[0021] FIG. 8 is a flowchart showing another embodiment of a state
through which the present software may run to perform certain
embodiments of the present methods.
[0022] FIG. 9 is a representation of one of the present datasets
stored in memory.
[0023] FIG. 10 is a flowchart showing another embodiment of a state
through which the present software may run to perform certain
embodiments of the present methods.
[0024] FIG. 11 illustrates an embodiment of one of the present
non-tissue internal reference markers.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0025] The terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has" and "having"), "contain" (and any form of contain, such as
"contains" and "containing"), and "include" (and any form of
include, such as "includes" and "including") are open-ended linking
verbs. Thus, a method, an apparatus, or a system that "comprises,"
"has," "contains," or "includes" one or more items possesses at
least those one or more items, but is not limited to possessing
only those one or more items. For example, a method that comprises
receiving a position of an instrument reference marker coupled to
an instrument; transforming the position into image space using a
position of a non-tissue internal reference marker implanted in a
patient; and superimposing a representation of the instrument on an
image in which the non-tissue internal reference marker appears
possesses at least the receiving, transforming, and superimposing
steps, but is not limited to possessing only those steps.
Accordingly, the method also covers instances where the
transforming includes transforming the position into image space
using a transformation that is based, in part, on the position of
the non-tissue internal reference marker implanted in the patient,
and calculating the transformation using image space coordinates of
the internal reference marker in the image. The term "use" should
be interpreted the same way. Thus, a calculation that uses certain
items uses at least those items, but also covers the use of
additional items.
[0026] Individuals elements or steps of the present methods,
apparatuses, and systems are to be treated in the same manner.
Thus, a step that calls for creating a dataset that includes
images, one of the images (a) depicting a non-tissue internal
reference marker, (b) being linked to non-tissue internal reference
marker positional information, and (c) being at least 2-dimensional
covers the creation of at least such a dataset, but also covers the
creation of a dataset that includes images, where each image (a)
depicts the non tissue internal reference marker, and (b) is linked
to non-tissue internal reference marker positional information.
[0027] The terms "a" and "an" are defined as one or more than one.
The term "another" is defined as at least a second or more. The
term "coupled" encompasses both direct and indirect connections,
and is not limited to mechanical connections.
[0028] Those of skill in the art will appreciate that in the
detailed description below, certain well known components and
assembly techniques have been omitted so that the present methods,
apparatuses, and systems are not obscured in unnecessary
detail.
[0029] Broadly, embodiments of the present methods, apparatuses,
and systems enable the use of dynamic imaging modalities in 2-D and
3-D IGI. Specifically, the various embodiments of the present
embodiments of the present methods, apparatuses, and systems are
useful for allowing a particular image from a set of images
depicting dynamic anatomy to be selected, such that the selected
image is the most accurate representation of the instantaneous
position and orientation of the live anatomy in the operating
theatre. The locations of the present reference markers (in the
form of vectors, for example) may be synchronized to each image in
the set of images, and the positional information of the markers
allows a transformation to be calculated between the real world
coordinate space and the image space for the purpose of
superimposing the live position of one or more instruments onto the
selected image. Dynamic anatomy is anatomy that moves significantly
with respect to heart beat and/or respiration, such as the heart,
lungs, kidneys, liver, and blood vessels.
[0030] More specifically, embodiments of the present methods,
apparatuses, and systems are useful for the placing and tracking
one or more non-tissue internal reference markers within a gross
anatomic region of interest that moves periodically with heart beat
and respiration, synchronizing the location or locations of those
marker locations with images that best describe the specific
anatomy of interest in a particular orientation, selecting the
image that best describes the anatomy of interest at any given
moment in the operating or procedure room, and superimposing iconic
representation of one or more instruments on the most accurate
image selected after making the appropriate transformation from the
tracking space of the instrument to image space. A "non-tissue
internal reference marker" is a reference marker, which is
sometimes referred to in the art as a "fiducial," that is
positioned inside of a patient (e.g., any living being, human or
otherwise) and that is not made from the patient's tissue or other
living matter. Embodiments of the present methods, apparatuses, and
systems may be used in the delivery of various medical therapies
including, but not limited to, pacemaker lead placement, coronary
stent placement, cardiac radio frequency ablation, lung biopsy,
renal stent placement, transjugular intrahepatic porto-systemic
shunting, and percutaneous radio frequency ablation of renal
masses.
[0031] IGI has not made significant inroads into medical procedures
involving dynamic anatomy. IGI is suited to, and has been used
primarily in, static anatomy medical procedures due to its usage of
static imaging modalities such as single frame fluoroscopy, and
single volume MRI and CT. While Rasche (i.e., U.S. Pat. No.
6,473,635) discloses certain IGI with dynamic anatomy, his proposed
method depends on the patient's ECG data during the operation. That
is, Rasche's method involves collecting ECG data as the operation
is taking place and, based on a given phase of that ECG data,
displaying an image for viewing by the physician. Such an approach
will not work if the patient exhibits an irregular ECG pattern due
to the medical therapies that are being applied to him. Examples of
induced ECG irregularity would occur during pacemaker and
implantable cardioverter defibrillator lead placement and
radiofrequency ablation of myocytes to cure tachycardia. The
present methods, apparatuses, and systems do not rely on ECG data
that is taken as an operation takes place in order to select the
appropriate pre-operative image to display for the physician.
[0032] Further, Rasche requires the use of an external reference
probe in calculating "a simple co-ordinate transformation" between
actual spatial and image coordinate systems. An external reference
marker will never produce the transformation accuracy of an
internal reference marker positioned close to the anatomy of
interest--as used by the present methods, apparatuses, and
systems--due to a moment arm escalation of error.
[0033] 1. Use of a Gated Image Dataset
[0034] FIG. 1 shows one embodiment of a system (system 100) that
includes components that can be used to perform image guided
interventions using a gated imaging modality, such as ECG-gated
MRI, or ECG-gated CT. The figure depicts a patient 10 positioned on
an operating table 12 with a physician 14 performing a medical
procedure on him.
[0035] Specifically, FIG. 1 depicts physician 14 steering a medical
instrument 16 through the patient's internal anatomy in order to
deliver therapy. In this particular instance, instrument 16 is
depicted as a catheter entering the right atrium by way of the
inferior vena cava preceded by a femoral artery access point;
however, the present systems are not limited to catheter use
indications. The position of virtually any instrument may be
tracked as discussed below and a representation of it superimposed
on the proper image, consistent with the present methods,
apparatuses, and systems. An "instrument" is any device controlled
by physician 10 for the purpose of delivering therapy, and includes
needles, guidewires, stents, filters, occluders, retrieval devices,
and leads. Instrument 16 is fitted with one or more instrument
reference markers 18. A tracker 20 (which is sometimes referred to
in the art as a "tracking system") is configured to track the type
of reference marker or markers coupled to instrument 16. Tracker 20
can be any type of tracking system, including but not limited to an
electromagnetic tracking system. An example of a suitable
electromagnetic tracking system is the AURORA electromagnetic
tracking system, commercially available from Northern Digital Inc.
in Waterloo, Ontario Canada. If tracker 20 is an electromagnetic
tracking system, element 20 would represent an electromagnetic
field generator that emits a series of electromagnetic fields
designed to engulf patient 10, and reference marker or markers 18
coupled to medical instrument 16 could be coils that would receive
an induced voltage that could be monitored and translated into a
coordinate position of the marker(s).
[0036] An external reference marker 22 can be placed in a location
close to the region of the patient where the procedure is to be
performed, yet in a stable location that will not move (or that
will move a negligible amount) with the patient's heart beat and
respiration. If patient 10 is securely fixed to table 12 for the
procedure, external reference marker 22 (which may be described as
"static") can be affixed to table 12. If patient 10 is not
completely secured to table 12, external reference marker 22 can be
placed on region of the back of patient 10 exhibiting the least
amount of movement. Tracker 20 can be configured to track external
reference marker 22.
[0037] One or more non-tissue internal reference markers 24 can be
placed in the gross region where the image guided navigation will
be carried out. Non-tissue internal reference marker(s) 24 should
be placed in an anatomic location that exhibits movement that is
correlated with the movement of the anatomy intended for image
guided navigation. This location will be internal to the patient,
in the gross location of the anatomy of interest.
[0038] Medical instrument 16, instrument reference marker(s) 18,
external reference marker 22, and non-tissue internal reference
marker(s) 24 can be coupled to converter 26 of system 100.
Converter 26, one example of which may be referred to in the art as
a break-out box, can be configured to convert analog measurements
received from the reference markers and tracker 20 into digital
data understandable by image guidance computing platform 30, and
relay that data to image guidance computing platform 30 to which
converter 26 can be coupled. Image guidance computing platform 30
can take the form of a computer, and may include a monitor on which
a representation of one or more instruments used during the IGI can
be displayed over an image of the anatomy of interest.
[0039] System 100 also includes a periodic human characteristic
signal monitor, such as ECG monitor 32, which can be configured to
receive a periodic human characteristic signal. For example, ECG
monitor 32 can be configured to receive an ECG signal in the form
of the ECG data transmitted to it by ECG leads 34 coupled to
patient 10. The periodic human characteristic signal monitor (e.g.,
ECG monitor 32) can also be configured to relay a periodic human
characteristic signal (e.g., ECG data) to image guidance computing
platform 30, to which it can be coupled.
[0040] Prior to the start of the image guided intervention,
non-tissue internal reference marker(s) 24--but not necessarily
static external reference marker 22--should be placed in the gross
region of interest for the procedure. After placement of non-tissue
internal reference marker(s) 24, patient 10 is to be scanned with
an imaging device, such as gated scanner 40, and the resulting
gated image dataset transferred to image guidance computing
platform 30, to which the imaging device is coupled and which can
reside in the operating or procedure theatre. Examples of suitable
imaging devices, and more specifically suitable gated scanners,
include ECG-gated MRI scanners and ECG-gated CT scanners. A
hospital network 50 may be used to couple gated scanner 40 to image
guidance computing platform 30.
[0041] The imaging device (e.g., gated scanner 40) can be
configured to create a gated dataset that includes pre-operative
images, one or more of which (up to all) are taken using the
imaging device and are linked to a sample of a periodic human
characteristic signal (e.g., a sample, or a phase, of an ECG
signal). Once patient 10 is scanned using the imaging device and
the gated dataset is transferred to and received by image guidance
computing platform 30, patient 10 can be secured to operating table
12 and the equipment making up system 100 (e.g., tracker 20,
converter 26, image guidance computing platform 30, ECG monitor 32,
and gated scanner 40) set up as shown in FIG. 1. Information can
then flow among the system 100 components.
[0042] At this point, a gated dataset created by gated scanner 40
resides on image guidance computing platform 30. FIG. 2 shows gated
dataset 42 residing in memory 44, which can reside in image
guidance computing platform 30. Gated dataset 42 is organized as a
set of images (I1, I2, I3, I4 . . . In) that are correlated with
periodic human characteristic signal samples (S1, S2, S3 . . . Sn).
In the embodiment shown, the periodic human characteristic signal
is taken to be an ECG signal, or waveform. FIG. 3 highlights the
relationship between the samples (S1 . . . Sn) and the images (I1 .
. . In) that were captured by gated scanner 40. Designations P, Q,
R, S, and T are designations well known in the art; they designate
depolarizations and re-polarizations of the heart. Gated scanner 40
essentially creates an image of the anatomy of interest at a
particular instant in time during the anatomy's periodic movement.
Image I1 corresponds to the image that was captured at the S1
moment of patient 10's ECG cycle. Similarly, I2 is correlated with
S2, and In with Sn.
[0043] After the gated scanning has occurred and the system 100
components are coupled to each other as shown in FIG. 1, software
running on image guidance computing platform 30 can begin its
operation sequence. The software first enters a Calibration State
as depicted in FIG. 4. The goal of the software during the
Calibration State is to construct a dataset (which, in at least one
embodiment, may be described as a look-up table) with dataset
vectors linked to the pre-operative images collected by the gating
scanner 40. In later states of operation, the look-up table will
allow the software to choose the image that best describes the
actual instantaneous orientation of the live anatomy. Each dataset
vector is a magnitude and direction constructed by examining the
location of static external reference marker 22 and non-tissue
internal reference marker(s) 24. In this regard, static external
reference marker 22 can act as an origin for a dataset vector that
begins at origin and ends at the internal reference marker(s) 24
location. (Multiple vectors may be used if there are multiple
non-tissue internal reference markers.)
[0044] FIG. 4 shows the flow of the Calibration State 60. At step
62, the software can load gated dataset 42 into memory 44 (as
depicted in FIG. 4). Next, the software can loop through each gated
signal sample (S1, S2 . . . Sn) while sampling the live periodic
human characteristic signal coming from patient 10 by way of the
periodic human characteristic signal monitor (e.g., ECG monitor
32). In the example shown in the figures, that signal is, like the
first periodic human characteristic signal used in constructing the
gated dataset, an ECG signal or waveform. Thus, element 64
represents each gated signal sample for which step 66--sampling of
the live ECG waveform--occurs. At step 68, the software compares
the sample from patient 10's live ECG waveform and compares it to
the gated signal sample in question (Si). When the software gets a
match (e.g., when the sample from the live ECG waveform matches
gated signal sample Si), it can, at step 70, poll tracker 20 to
obtain the positions of static external reference marker 22 and
non-tissue internal reference marker(s) 24 in order to, at step 72,
construct, or calculate, a dataset vector (Vi). A match can be
ascertained using signal processing techniques that, in the case of
the ECG waveform, examine historical waveform amplitudes. Once the
dataset vector is constructed, at step 74, the dataset vector can
be stored in the look-up table with a pointer to the image (Ii)
that corresponded with the gated signal sample (Si) of gated
dataset 42. That is, the dataset vector can be linked to, or
associated with, that particular image (Ii). After the software has
looped through all the gated signal samples (S1 . . . Sn) of gated
dataset 42, constructed a dataset vector (V1 . . . Vn) for each
sample, and linked that dataset vector with the appropriate image
(I1 . . . In), the software is ready to move on. At this time, the
periodic human characteristic signal monitor (e.g., ECG monitor 32)
may be turned off or otherwise removed from system 100--it is no
longer needed. In at least one embodiment, the dataset vectors
described above may comprise nothing more than the tracking space
coordinates of the external reference marker 22 and non-tissue
internal reference marker(s) 24; as a result, step 72 is not
needed, and the linking of the dataset vectors to the various
images of gated dataset 42 will comprise linking the tracking space
coordinates of the relevant reference markers to those images.
[0045] The final step of Calibration State 60 is a transformation
calculation step. The software will file through each dataset
vector in the look-up table, as noted by element 75, and examine
each mapped image. At step 76, the image space coordinates of
non-tissue internal reference marker(s) 24 in each image (Ii) will
be determined. For example, each image (Ii) can undergo a
thresh-holding segmentation that will allow the software to find
the image space coordinates of non-tissue internal reference
marker(s) 24 in that image. Once the image space coordinates (e.g.,
voxel, volumetric pixel, coordinates) of non-tissue internal
reference marker(s) 24 are known, the positions (e.g., the tracking
space positions) of the external reference marker 22 and the
non-tissue internal reference marker(s) 24 received at step 70 can
be used to calculate a transformation (using a least squares
method) between the tracking space and the image space. Step 78 is
the calculation of such a transformation (Ti), and step 80 is the
linking of the transformation (Ti) to the image (Ii) in question.
As a result of that linking, the look-up table will comprise a
dataset that includes pre-operative images, at least one the images
(and, moreover, each image) depicting non-tissue internal reference
marker(s) 24, being linked to a dataset vector and a
transformation, and being at least 2-dimensional.
[0046] After completion of Calibration State 60, the software moves
the system into Navigate State 90 as depicted in FIG. 5. In this
state, the software can enter an infinite loop of events, as
designated by element 92. The first step in the loop, step 94,
image guidance computing platform 30 can poll the tracker 20 via
converter 26 in order to obtain the current position of external
reference marker 22 and the current position of non-tissue internal
reference marker(s) 24. (It should be understood that "current" in
this context is not limiting, and does not mean "instantaneous" or
the like; instead, "current" is simply an adjective used to
differentiate between the positions received at this step in the
present methods from the positions received earlier, for example.)
The software can then, at step 96, construct a current vector
(here, again, "current" is non-limiting) using the current
positions received at step 94. At step 98, the software can compare
the current vector to the dataset vectors (V1 . . . Vn) (or will
compare just the current positions to the tracking space
coordinates) in search of the dataset vector closest to the current
vector in question. Upon finding, at step 101, a match dataset
vector--defined as the dataset vector (Vi) (or tracking space
coordinates) most similar to the current vector (or current
positions, or coordinates)--the software can, at step 102, load
(e.g., into memory) the image (Ii) from gated dataset 42 pointed to
by the matching look-up table dataset vector (Vi). At step 104, the
software can also load (e.g., into memory) the transformation (Ti)
associated with the dataset vector (Vi) and the correlated image
(Ii). At step 106, the system can poll tracker 20 to obtain, via
converter 26, the position of instrument reference marker(s) 18.
The software can, at step 108, apply the transformation (Ti) to the
position of the instrument reference marker(s) 18 to transform that
position into image space. At step 110, the software can
superimpose (e.g., render, draw, etc.) a representation (e.g., an
iconic representation) of instrument 16 (or instruments, as the
case may be) on the selected image (Ii) to be displayed on a
monitor of image guidance computing platform 30.
[0047] The Navigation State 90 steps can be repeated continuously
and their performance will provide physician 14 with a live
representation of his instruments with respect to the instantaneous
position and orientation of the anatomy in question as he image
guides those instruments to their correct locations to deliver
medical therapy.
[0048] A basic embodiment of the present methods that may be
achieved using the system 100 software described above is a method
that includes creating a dataset that includes images, at least one
of the images: depicting a non-tissue internal reference marker,
being linked to non-tissue internal reference marker positional
information (such as a dataset vector), and being at least 2-D. In
another embodiment, and as described above, each image in the
dataset depicts a non-tissue internal reference marker (e.g.,
marker(s) 24), and is linked to non-tissue internal reference
marker positional information. The non-tissue internal reference
marker positional information may, for example, take the form of
positional coordinates or a dataset vector. The images may be 3-D
CT images or 3-D MRI images. Other embodiments of the present
methods include taking one or more additional steps from among
those steps described above. Thus, and by way of example, another
embodiment of the present methods includes loading a gated dataset
into memory that includes the images, at least one of the images
depicting the non-tissue internal reference marker and being linked
to a sample of a periodic human characteristic signal. In still
another embodiment, each image in the gated dataset depicts the
non-tissue internal reference marker and is linked to a sample of
the periodic human characteristic signal.
[0049] Another basic embodiment of the present methods that may be
achieved using the system 100 software described above is a method
that includes receiving a position of an instrument reference
marker coupled to an instrument (e.g., a medical instrument);
transforming the position into image space using a position of a
non-tissue internal reference marker implanted in a patient; and
superimposing a representation of the instrument on an image in
which the non-tissue internal reference marker appears. In another
embodiment, the transforming includes transforming the position
into image space using a transformation that is based, in part, on
the position of the non-tissue internal reference marker implanted
in the patient. And in yet another embodiment, the method also
includes calculating the transformation using image space
coordinates of the internal reference marker in the image. Other
embodiments of the present methods include taking one or more
additional steps from among those steps described above.
[0050] Periodic human characteristic signals other than ECG signals
may be used consistently with the steps described above. For
example, respiration or hemodynamic characteristics of patient 10
could just as easily be used as periodic human characteristic
signals. If such signals are used, appropriate periodic human
characteristic signal monitors should be used as well. Furthermore,
any imaging modality (not just CT or MRI) that can be gated to a
periodic human characteristic signal may be used consistently with
the steps described above, including positron emission tomography
(PET), ultrasound, and functional MRI (fMRI).
[0051] 2. Use of CINE Fluoroscopy
[0052] FIG. 6 depicts one embodiment of a system (system 200) that
includes components (many of which are the same, and are coupled in
the same fashion, as those in system 100) that can be used to
perform image guided interventions using CINE 2-D fluoroscopy as an
imaging modality. Gated scanner 40 and hospital network 50 in
system 100 are replaced with fluoroscope 215, which, as shown, can
include fluoroscope stand 210, fluoroscope receiver unit 212 (e.g.,
a fluoroscope radiation receiver unit), and fluoroscope calibration
jig 214. Fluoroscope 215 is coupled to image guidance computing
platform 30.
[0053] One advantage of using CINE fluoroscopy as an image guidance
modality is that it can be captured during the procedure in the
operating or procedure theatre. As a result, the physician may
dispense with the gating of a periodic human characteristic signal
to pre-operative images. Generally speaking, FIG. 7 captures what
will happen using CINE fluoroscopy; a non-tissue internal reference
marker(s) 24 will be placed as described above and tracked as each
image (I1, I2 . . . In) is captured using fluoroscope 215, and more
specifically fluoroscope receiver unit 212. The placement of such
internal reference markers is shown in FIG. 7 with respect to the
heart, and more specifically, with respect to various stages of the
heart's function (A1, A2 . . . An). Vectors (V1, V2 . . . Vn) that
are based on the positions of an external reference marker (not
shown) and non-tissue internal reference marker 24 (shown) are
depicted in FIG. 7 in terms of the X, Y, and Z axis information.
Those vectors will be discussed in more detail below. After the
image capture process is complete, the particular image most
accurately depicting the anatomy at a particular instant can be
ascertained by examining the position of the non-tissue internal
reference marker(s), and selecting the image that was captured when
the marker was last in that particular location and
orientation.
[0054] To begin the image guided intervention, patient 10 will be
placed upon operating table 12 and an ECG monitor 32 will likely be
connected to patient 10 for diagnostic purposes unrelated to
performing image guidance. Fluoroscope 215 can be positioned to
allow images to be captured of patient 10 (likely in an orientation
that physician 14 is most comfortable with, such as a Right
Anterior Oblique (RAO) view). Physician 14 can place an external
reference marker 22 as discussed above (e.g., in the procedural
field on a location that does not move with respect to heartbeat
and respiration). One or more non-tissue internal reference
marker(s) 24 can be placed in the gross region of the anatomy
intended for image guidance. Fluoroscope calibration jig 214 can be
coupled to fluoroscope receiver unit 212. All connections between
fluoroscope 215, reference markers 22 and 24, converter 26, and
image guidance computing platform 30 can be fulfilled as depicted
in FIG. 6, and information can then flow among the system 200
components.
[0055] At this time, system 200 is ready to enter the Calibration
State 250 as depicted in FIG. 8. First, physician 14 can trigger
fluoroscope 215 to begin acquiring an image signal (e.g., a CINE
fluoroscopy loop). As fluoroscope 215 begins to acquire the image
signal, the live video feed can be sent to, and received by, image
guidance computing platform 30.
[0056] While fluoroscope 215 is acquiring the CINE loop, as noted
with element 252, the software can, as step 254 notes, sample the
live video feed. Sampling consistent with step 254 can occur at a
rate greater than 30 Hz so as capture enough images (e.g., image
frames) such that they will, when pieced together, appear to be
real time to the human eye. As computing power makes faster
sampling rates for more feasible, a sampling rate greater than 60
Hz can be implemented in accordance with Nyquist's Law.
[0057] The software can create an image (e.g., an image frame) (Ii)
as denoted in FIG. 7 and, at step 256, store that image into
memory. The software can also poll the tracker 20 and receive, at
step 258, positional information for (e.g., the positions of) the
reference markers (e.g., static external reference marker 22 and
non-tissue internal reference marker(s) 24). The system can then,
at step 260, construct, or calculate, a dataset vector (see V1 . .
. Vn in FIG. 7) defining the orientation of the reference markers
during the instantaneous acquisition of this particular image (Ii).
The software can, at step 262, record the dataset vector (Vi) (or
at least the positional information) and the associated image (Ii)
in a dataset (e.g., dataset 300, which can, in at least one
embodiment, take the form of a look-up table) as depicted in FIG.
9. Step 262 may also be described as creating a dataset that
includes at least one image that depicts a non-tissue internal
reference marker, is linked to positional information about the
non-tissue internal reference marker, and is at least 2-D. FIG. 9
shows dataset 300 residing in memory 44, which can reside in image
guidance computing platform 30. After a sufficient number of images
have been collected and stored, the software begin the
transformation calculation process. For example, for each image
(Ii), as noted by element 263, the software can, at step 264, poll
tracker 20 for, and can receive, the position of the fluoroscope
calibration jig 214. With this positional information, the software
can, at step 266, calculate a transformation (Ti) from tracking
space (e.g., the tracker field coordinate space) to image space
(e.g., the fluoroscope image space) using the methods disclosed in
U.S. Pat. No. 6,470,207. At step 268, the transformation (Ti) can
be stored in association with (e.g., linked to) the image (Ii) in
the look-up table associated with, or keyed by, database vector
(Vi). This step may also be described as associating the
transformation (Ti) with image (Ii). The software can repeat this
process until a complete set of images necessary to characterize
the anatomy over its entire periodic cycle of movement have been
captured and characterized.
[0058] After completion of Calibration State 250, the software
moves the system into Navigate State 350. In this state, the
software can enter an infinite loop of events, as designated by
element 352. In the first step in the loop, step 354, image
guidance computing platform 30 polls the tracker 20 via converter
26 in order to obtain the current position of external reference
marker 22 and the current position of non-tissue internal reference
marker(s) 24. (It should be understood that "current" in this
context is not limiting, and does not mean "instantaneous" or the
like; instead, "current" is simply an adjective used to
differentiate between the positions received at this step in the
present methods from the positions received earlier, for example.)
The software can then, at step 356, construct a current vector
(here, again, "current" is non-limiting) using the current
positions received at step 354. At step 358, the software can
compare the current vector to the dataset vectors (V1 . . . Vn) (or
will compare just the current positions to the tracking space
coordinates) in search of the dataset vector closest to the current
vector in question. Upon finding, at step 360, a match dataset
vector--defined as the dataset vector (Vi) (or tracking space
coordinates) most similar to the current vector (or current
positions, or coordinates)--the software can, at step 362, load
(e.g., into memory) the image (Ii) from dataset 300 pointed to by
the matching look-up table dataset vector (Vi). At step 364, the
software can also load (e.g., into memory) the transformation (Ti)
associated with the dataset vector (Vi) and the correlated image
(Ii). At step 366, the system can poll tracker 20 to obtain, via
converter 26, the position of instrument reference marker(s) 18.
The software can, at step 368, apply the transformation (Ti) to the
position of the instrument reference marker(s) 18 to transform that
position into image space. At step 370, the software can
superimpose (e.g., render, draw, etc.) a representation (e.g., an
iconic representation) of instrument 16 (or instruments, as the
case may be) on the selected image (Ii) to be displayed on a
monitor of image guidance computing platform 30.
[0059] The Navigation State 350 steps can be repeated continuously
and their performance will provide physician 14 with a live
representation of his instruments with respect to the instantaneous
position and orientation of the anatomy in question as he image
guides those instruments to their correct locations to deliver
medical therapy.
[0060] A basic embodiment of the present methods that may be
achieved using the system 200 software described above is a method
that includes creating a dataset that includes images, at least one
of the images: depicting a non-tissue internal reference marker,
being linked to non-tissue internal reference marker positional
information (such as a vector), and being at least 2-D. In another
embodiment, and as described above, each image in the dataset
depicts a non-tissue internal reference marker (e.g., marker(s)
24), and is linked to non-tissue internal reference marker
positional information. The non-tissue internal reference marker
positional information may, for example, take the form of
positional coordinates or a dataset vector. The images may be 2-D
fluoroscopy images (e.g., CINE fluoroscopy images). Other
embodiments of the present methods include taking one or more
additional steps from among those steps described above. Thus, and
by way of example, another embodiment of the present methods
includes calculating a dataset vector using a position of an
external reference marker and a position of a non-tissue internal
reference marker.
[0061] Another basic embodiment of the present methods that may be
achieved using the system 200 software described above is a method
that includes receiving a position of an instrument reference
marker coupled to an instrument (e.g., a medical instrument);
transforming the position into image space using a position of a
non-tissue internal reference marker implanted in a patient; and
superimposing a representation of the instrument on an image in
which the non-tissue internal reference marker appears. In another
embodiment, the transforming includes transforming the position
into image space using a transformation that is based, in part, on
the position of the non-tissue internal reference marker implanted
in the patient. And in yet another embodiment, the method also
includes calculating the transformation using image space
coordinates of the internal reference marker in the image. Other
embodiments of the present methods include taking one or more
additional steps from among those steps described above.
[0062] 3. Non-Tissue Internal Reference Marker
[0063] An example of a non-tissue internal reference marker
suitable for use as non-tissue internal reference marker 24 for use
with system 100 is shown in FIG. 11. In the case where the imaging
modality used for the purposes of image guided intervention is MRI,
the non-tissue internal reference marker(s) 24 placed into the
patient can be non-ferrous to meet safety requirements of the
imaging device (e.g., gated scanner 40). FIG. 11 depicts such an
apparatus. Apparatus 400 includes a non-ferrous body (i.e., a body
that is not made of any iron) 410 that defines a chamber 412. Body
410 can be made of a material that makes it opaque to the imaging
modality such that it shows up as a blank (white) spot on the
image. Such materials include platinum and titanium. A non-ferrous
tissue fixation member 414 is coupled (e.g., through attachment) to
body 410 at an end of body 410 to allow apparatus 400 to be
implanted in the gross region of interest for a procedure. Member
414, as shown, can have a pig-tail shape. As a result, member 414
can be unscrewed to release the apparatus after completion of the
procedure. Such pig-tail designs are common among temporary pacing
leads in the field of cardiac electrophysiology. The embodiment of
apparatus 400 shown in FIG. 11 also includes a segment 416 (such as
a sheath, or a portion of a sheath) coupled to body 410. Segment
416 includes a passageway 418 that is in communication with chamber
412. The segment can be plastic. Any portion of segment 418 that
extends outside of a patient is not considered to be a part of any
of the present non-tissue internal reference markers.
[0064] When apparatus 400--as a non-tissue internal reference
marker--is implanted prior to imaging, chamber 412 can remain
empty. The patient into which the apparatus is implanted can be
scanned with apparatus 400 implanted and segment 418 in place,
which can extend outside of the patient (e.g., outside of the
patient's skin). Upon successful completion of the scan, one or
more ferrous tracking sensors 420 that are configured for placement
in chamber 412 and their ferrous connecting leads 422 (e.g., wires)
can be introduced into chamber 412 via segment 416 and locked into
place. This apparatus, therefore, alleviates the need for the
tracking sensors to be non-ferrous.
[0065] As will be understood by those having skill in the art and
the benefit of this disclosure, the steps disclosed above, and the
techniques for carrying them out, may be implemented in any number
of various media or devices. While described above in terms of
software, it should be understood that the referenced software may
take the form of machine (e.g., computer) readable instructions on
computer readable media. The computer-readable, or machine-readable
media, may take many forms, including any data storage device that
can store data that can afterwards be read by a computer or a
computer system, including a disk, such as a floppy disk, a zip
disk, or the like; a server, read-only memory; random access
memory; CD-ROMs; a memory card; magnetic tape; optical data storage
devices, SMARTMEDIA.RTM. cards; flash memory; compact flash memory;
and the like. The computer readable medium can also be distributed
over network-coupled computer systems so that the computer readable
instructions are stored and executed in a distributed fashion. For
example, the computer readable medium may take the form of a
carrier wave such as, for example, signals on a wire (e.g., signals
downloaded from the Internet) or those that are transmitted
electromagnetically or through infra red means. Furthermore, when
the machine readable instructions in question have been loaded onto
a given machine, that machine can be described as configured to
take whatever actions are defined by the instructions.
[0066] In another embodiment, any of the present methods may be
embodied in an integrated circuit, such as application specific
integrated circuit (ASIC), or in a field programmable gate array
(FPGA). In another embodiment, any of the present methods may be
embodied by a combination of hardware and software; for instance,
certain instructions may be executed by a chip running appropriate
firmware. In another embodiment, any of the present methods may be
embodied by a kit, such as a software developer's kit. Such a kit
may include not only software, but also any corresponding hardware
to execute the software. For instance, a kit may include a computer
board along with drivers and software to be run by that board.
Those having skill in the art will recognize that the present
methods may be implemented by other means known in the art to
achieve an identical or similar result. All such means are
considered to be within the scope of the present methods and
systems that include devices configured to carry out the present
methods.
[0067] The claims are not to be interpreted as including
means-plus- or step-plus-function limitations, unless such a
limitation is explicitly recited in a given claim using the
phrase(s) "means for" or "step for," respectively.
* * * * *