U.S. patent application number 13/405290 was filed with the patent office on 2012-06-21 for bodily sealants and methods and apparatus for image-guided delivery of same.
Invention is credited to Jerome R. Edwards, Troy L. Holsing, Christopher B. Lee, Torsten M. Lyon.
Application Number | 20120158047 13/405290 |
Document ID | / |
Family ID | 41267472 |
Filed Date | 2012-06-21 |
United States Patent
Application |
20120158047 |
Kind Code |
A1 |
Edwards; Jerome R. ; et
al. |
June 21, 2012 |
BODILY SEALANTS AND METHODS AND APPARATUS FOR IMAGE-GUIDED DELIVERY
OF SAME
Abstract
Generally, systems, methods, and apparatus related to the use of
a dynamic imaging modality in an image guided intervention are
disclosed herein. More specifically, the use of such modalities in
sealing a bodily opening, such as those that may be formed during
an invasive medical procedure are disclosed herein. In some
embodiments, a method includes viewing a representation of an
instrument within a body of a patient, adjusting a position of the
instrument based on the viewing such that a portion of the
instrument is at a location within the body of the patient, and
delivering a sealant via the instrument to the location within the
body of the patient. The sealant is configured to seal an opening
in the body part.
Inventors: |
Edwards; Jerome R.; (St.
Louis, MO) ; Lee; Christopher B.; (St. Louis, MO)
; Holsing; Troy L.; (Richmond Heights, MO) ; Lyon;
Torsten M.; (St. Louis, MO) |
Family ID: |
41267472 |
Appl. No.: |
13/405290 |
Filed: |
February 25, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12267200 |
Nov 7, 2008 |
8150495 |
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13405290 |
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12146738 |
Jun 26, 2008 |
7853307 |
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12267200 |
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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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60986035 |
Nov 7, 2007 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 34/10 20160201;
A61B 5/352 20210101; A61B 17/00491 20130101; A61B 90/36 20160201;
A61B 5/062 20130101; A61B 2090/3916 20160201; A61B 34/20 20160201;
A61B 2017/00703 20130101; A61B 5/7285 20130101; A61B 2090/3954
20160201; A61B 2034/2051 20160201; A61B 8/0833 20130101; A61B 6/12
20130101; A61B 6/541 20130101; A61B 2090/3958 20160201; A61B
2090/3983 20160201; A61B 2034/2072 20160201 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/03 20060101
A61B017/03 |
Claims
1-14. (canceled)
15. An apparatus, comprising: a first shaft defining a lumen and an
opening in communication with the lumen of the first shaft, at
least a portion of the first shaft disposable within a body of a
patient; and a second shaft defining a chamber and an opening in
communication with the chamber of the second shaft, the chamber of
the second shaft configured to receive a sealant, the second shaft
configured to be movably received within the lumen of the first
shaft, the second shaft having a first position in which the
opening of the second shaft is fluidically isolated from the
opening of the first shaft and a second position in which the
opening of the second shaft is in fluid communication with the
opening of the first shaft, the opening of the first shaft and the
opening of the second shaft defining a flow passageway for the
sealant when the second shaft is in its second position.
16. The apparatus of claim 15, wherein the flow passageway is
configured to permit movement of the sealant from the chamber of
the second shaft to a location exterior to the first shaft.
17. The apparatus of claim 15, wherein the second shaft defines a
lumen, the lumen configured to receive a medical instrument, the
medical instrument being at least one of a light source, a scope, a
biopsy tool, or a camera.
18. The apparatus of claim 15, wherein the second shaft defines a
lumen fluidically isolated from the chamber of the second shaft,
the lumen of the second shaft configured to receive a medical
instrument, the medical instrument being at least one of a light
source, a scope, a biopsy tool, or a camera.
19. The apparatus of claim 15, wherein at least one of the first
shaft or the second shaft includes a reference marker, the
reference marker viewable by an imaging device that is exterior the
body of the patient when the reference marker is disposed within
the body of the patient.
20. The apparatus of claim 15, wherein the second shaft is movable
with respect to the first shaft in at least one of a rotational
direction or a translational direction.
21. The apparatus of claim 15, wherein the first shaft includes a
coating disposed on an outer surface of at least a portion of the
first shaft, the coating configured to form a seal between the
portion of the first shaft and a portion of the body of the patient
in contact with the outer surface of the portion of the first
shaft.
22. The apparatus of claim 15, wherein the sealant includes at
least one of thrombin, fibrinogen, a cyanocrylate, collagen, a
cross-linker, an aldehyde, or a hydrogel.
23. The apparatus of claim 15, further comprising: a sensor coupled
to a distal end portion of at least one of the first shaft or the
second shaft, the sensor configured to sense a pressure within a
portion of the body of the patient in which the sensor is
disposed.
24-37. (canceled)
38. An apparatus comprising: an elongate member defining a lumen,
at least a portion of the elongate member configured to define an
opening within a bodily tissue; and a coating disposed on at least
a portion of an outer surface of the elongate member, the coating
configured to form a seal between the elongate member and the
bodily tissue when the elongate member is disposed within the
opening of the bodily tissue.
39. The apparatus of claim 38, wherein the coating includes at
least one of thrombin, fibrinogen, a cyanocrylate, collagen, a
cross-linker, an aldehyde, or a hydrogel.
40. The apparatus of claim 38, wherein the elongate member includes
a marker, the marker disposable within a body of a patient, the
marker viewable by an imaging device that is exterior to the body
of the patient when the marker is disposed within the body of the
patient.
41. The apparatus of claim 38, wherein the coating is configured to
change from a first physical state to a second physical state
different than the first physical state in response to contacting
at least one of the bodily tissue, a bodily fluid, or a second
coating.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and is a
continuation-in-part of U.S. patent application Ser. No.
12/146,738, filed on Jun. 26, 2008, entitled "Methods, Apparatuses,
and Systems Useful in Conducting Image Guided Interventions," which
claims priority to and is a continuation of U.S. Pat. No.
7,398,116, filed on Aug. 26, 2003, entitled, "Methods, Apparatuses,
and Systems Useful in Conducting Image Guided Interventions," which
claims priority to U.S. Provisional Patent Application Ser. No.
60/494,268, filed Aug. 11, 2003, entitled "Methods, Apparatuses,
and Systems Useful in Conducting Image Guided Interventions," the
entire contents of each are hereby incorporated by reference.
[0002] This application also claims priority to U.S. Provisional
Patent Application Ser. No. 60/986,035, filed Nov. 7, 2007,
entitled "Self-Sealing Body Access Apparatus," the entire contents
of which is hereby incorporated by reference.
BACKGROUND
[0003] Image guided surgery, also known as image guided
intervention (IGI), is used to enhance a physician's understanding
of the location of a medical instrument within a patient's body
during a medical procedure. Some known IGI applications include the
use of 2-dimensional (2-D) and 3-dimensional (3-D) imaging
modalities. The usefulness of known techniques, however, is limited
to procedures involving relatively static anatomy. In other words,
the usefulness of known techniques is generally limited to use with
respect to anatomy that exhibits no or minimal movement with
respect to cardiac and/or respiratory cycles.
[0004] Thus, known IGI techniques have limited application, if any,
in medical procedures involving dynamic anatomy (i.e., anatomy that
exhibits more than minimal movement with respect to cardiac and
respiratory cycles).
[0005] Moreover, known IGI systems fail to account for imaging data
that includes an irregular pattern exhibited by a patient, such as
an irregular pattern resulting from the application of a medical
therapy to the patient. For example, in certain instances, a
patient may have an irregular ECG waveform pattern as a result of
implantation of a pacemaker and/or a cardioverter defibrillator
lead. In another example, a patient may have an irregular ECG
waveform pattern as a result of radiofrequency ablation of myocytes
to cure tachycardia.
[0006] Known IGI systems can use an external reference probe to
calculate a transformation between a spatial coordinate system
(e.g., in the patient space) and an image coordinate system (e.g.,
in the image space as acquired by the imaging modality). In certain
instances, such known external probes can fail to produce a desired
transformation accuracy due to a moment arm escalation of error. In
other words, in certain circumstances, the accuracy of the
transformation of known IGI systems can be adversely affected by
the distance between the target anatomy and the external probe.
Although some IGI systems include a reference probe configured to
be inserted into the body, such known reference probes are
positioned on a proximal end portion of the instrument, and thus
fail to remedy the moment arm escalation of error.
[0007] Use of known instruments in a medical procedure can result
in the penetration, incising, puncturing, or otherwise accessing a
portion of the patient's anatomy. Such procedures, however, can
result in many harmful side effects. For example, in a procedure
involving access to the patient's lung, the lung may collapse
and/or pneumothorax may occur when the chest wall is punctured.
Furthermore, foreign substances may enter the patient's body and/or
a portion of the patient's anatomy through the site of entry.
[0008] Thus, a need exists for improved apparatus and methods for
sealing an opening (e.g., a site of entry) within a patient's body.
Moreover, a need exists for improved methods for using image guided
surgery to seal such an opening.
SUMMARY
[0009] Generally, systems, methods, and apparatus related to the
use of a dynamic imaging modality in an image guided intervention
are disclosed herein. More specifically, the use of such modalities
in sealing a bodily opening, such as those that may be formed
during an invasive medical procedure are disclosed herein. In some
embodiments, a method includes viewing a representation of an
instrument within a body of a patient, adjusting a position of the
instrument based on the viewing such that a portion of the
instrument is at a location within the body of the patient, and
delivering a sealant via the instrument to the location within the
body of the patient. The sealant is configured to seal an opening
in the body part.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a schematic illustration of a system according to
an embodiment, and a physician and a patient.
[0011] FIG. 2 is a schematic illustration of a dataset according to
an embodiment stored in a portion of the system of FIG. 1.
[0012] FIG. 3 is a schematic illustration of a sample of a periodic
human characteristic signal associated(e.g., gated), with a set of
images according to an embodiment.
[0013] FIG. 4 is a flow chart of a method according to an
embodiment.
[0014] FIG. 4A is a schematic illustration of a dataset according
to an embodiment stored in a portion of the system of FIG. 2.
[0015] FIG. 5 is a flow chart of a method according to an
embodiment.
[0016] FIG. 6 is a schematic illustration of a system according to
an embodiment, and a physician and a patient.
[0017] FIG. 7 is a set of images produced by the system of FIG.
6.
[0018] FIG. 8 is a flow chart of a method according to an
embodiment.
[0019] FIG. 9 is a flow chart of a method according to an
embodiment.
[0020] FIG. 10 is a front view of a portion of the system of FIG.
1.
[0021] FIG. 11 is a front view of an apparatus according to an
embodiment.
[0022] FIG. 12 is a top view of the apparatus of FIG. 11.
[0023] FIG. 13 is a cross-sectional view of the apparatus of FIG.
11 taken along line X.sub.1-X.sub.1 of FIG. 12.
[0024] FIG. 14 is a front view of an apparatus according to an
embodiment.
[0025] FIG. 15 is a cross-sectional view of the apparatus of FIG.
14.
[0026] FIG. 16 is a cross-sectional view of an apparatus according
to an embodiment.
[0027] FIGS. 17 and 18 are cross-sectional views of an apparatus
according to an embodiment in a first configuration and a second
configuration, respectively.
[0028] FIG. 19 is a perspective view of a portion of the apparatus
of FIGS. 17 and 18.
[0029] FIG. 20 is a cross-sectional view of the portion of the
apparatus illustrated in FIG. 19 taken along line X.sub.2-X.sub.2,
and a cross-section of a portion of a medical instrument.
[0030] FIG. 21 is a flow chart of a method according to an
embodiment.
DETAILED DESCRIPTION
[0031] Generally, apparatus and methods directed to enabling the
use of dynamic imaging modalities in a 2-dimensional (2-D),
3-dimensional (3-D), and/or 4-dimensional (4-D) image guided
intervention (IGI), and specifically to use of such modalities in
sealing a bodily opening, such as those that may be formed during
an invasive medical procedure, are described herein. Also disclosed
herein are apparatus and methods for sealing such a bodily opening
in the patient, and specifically to apparatus and methods for
sealing such an opening in a dynamic bodily tissue.
[0032] In some embodiments, for example, a system is configured for
use with respect to a target dynamic anatomy, or anatomy that
exhibits more than minimal movement with respect to a patient's
cardiac and/or respiratory cycle (e.g., with respect to the
patient's heartbeat and/or breathing). Examples of such target
anatomy include the heart, lungs, kidneys, liver, and/or blood
vessels. The system can be configured to synchronize positional
information associated with a location of at least one reference
marker disposed proximate to the body of the patient with at least
one image that represents the target anatomy of the patient when
the target anatomy is in a particular orientation and/or
configuration. In some embodiments, the system is configured to
select an image that represents the target anatomy at a specified
time (e.g., a time at which expiration of air from the lungs is
occurring). The system is configured to superimpose a
representation of a medical instrument on the image after making a
transformation of the instrument from a tracking space (e.g., an
area proximate to the patient's body, or a real coordinate space)
to an image space (e.g., a computer-assisted representation of the
image of the target anatomy).
[0033] In another example, a method according to an embodiment
includes selecting an image from a set of images depicting a target
dynamic anatomy such that the selected image is associated with a
current position and/or orientation of the target dynamic anatomy
in an operating theatre (e.g., a medical facility, a doctor's
office, or an operating room). The method can include synchronizing
a location of a reference marker that is proximate to the body of
the patient (in the form of a vector, for example) to each image in
the set of images. The method can also include calculating a
transformation between a tracking space and an image space using
the positional information of the marker in order to superimpose a
live (or current) position of a medical instrument onto a display
of the image.
[0034] In yet another example, a method of delivering a sealant
using a dynamic imaging modality includes viewing a representation
of an instrument disposed within a body of a patient. The
representation of the instrument is superimposed on an image from a
set of images associated with a cyclical movement of a body part.
The image is associated with a match dataset vector (MDV). The MDV
is a dataset vector associated with a current vector that is
calculated based on a current position of a first reference marker
and a current position of a second reference marker. The second
reference marker is depicted in at least one image from the set of
images. The method includes adjusting a position of the instrument
based on the viewing such that a portion of the instrument is at a
location within the body of the patient. The location can be, for
example, adjacent a surface of a body part (e.g., the heart, the
lung, etc.) The method includes delivering a sealant via the
instrument to the location within the body of the patient. The
sealant is configured to seal an opening in the body part.
[0035] In some embodiments, for example, an apparatus includes a
first shaft and a second shaft. The first shaft defines a lumen and
an opening in communication with the lumen of the first shaft. At
least a portion of the first shaft is disposable within a body of a
patient. The second shaft defines a chamber and an opening in
communication with the chamber of the second shaft. The chamber of
the second shaft is configured to receive a sealant. The second
shaft is configured to be movably received within the lumen of the
first shaft. The second shaft has a first position in which the
opening of the second shaft is fluidically isolated from the
opening of the first shaft and a second position in which the
opening of the second shaft is in fluid communication with the
opening of the first shaft. The opening of the first shaft and the
opening of the second shaft define a flow passageway for the
sealant when the second shaft is in its second position.
[0036] In some embodiments, an apparatus includes an elongate shaft
and a delivery mechanism. The elongate shaft has a proximal end
portion and a distal end portion. The elongate shaft defines a
lumen. At least a portion of the elongate shaft is disposable
within a body of a patient. The delivery mechanism is movably
coupled to the elongate shaft. The delivery mechanism is configured
to move a seal member configured to seal an opening within the body
of the patient between a collapsed configuration and an expanded
configuration. At least a portion of the seal member is disposed
within the lumen of the elongate shaft when the seal member is in
the collapsed configuration. The seal member is configured to be
disposed in the body of the patient apart from the elongate shaft
and the delivery mechanism.
[0037] In some embodiments, an apparatus includes an elongate
member that defines a lumen. At least a portion of the elongate
member is configured to define an opening within a bodily tissue. A
coating is disposed on at least a portion of an outer surface of
the elongate member. The coating is configured to form a seal
between the elongate member and the bodily tissue when the portion
of the elongate member is within the opening of the bodily
tissue.
[0038] In some embodiments, an apparatus includes a substrate and a
sealant. The substrate has a first surface and a second surface
different than the first surface. The substrate is couplable to a
dynamic bodily tissue within a bodily cavity of a patient. The
substrate is penetrable by a medical instrument. The sealant is
disposed on a portion of the substrate. The sealant is penetrable
by the medical instrument. The sealant is configured to
substantially prevent passage of a material through an opening in
the substrate formed by the medical instrument.
[0039] FIG. 1 is an illustration of a system 100 according to an
embodiment. The system 100 can be configured to perform
segmentation, correlation and registration between data obtained in
"image space" (position data taken pre-procedurally) and data
obtained in "tracking space" (position data obtained during a later
medical procedure), as described herein and as described in detail
in U.S. Patent Publication No. 2007/0060799, filed Apr. 25, 2006,
entitled, "Apparatus and Method for Automatic Image Guided Accuracy
Verification," (the "'799 Application") the entire contents of
which is hereby incorporated by reference.
[0040] The system 100 includes an imaging device 40, a processor
30, reference markers 18, 22, 24, a tracker 20, a converter 26, and
a monitor 32. The system 100 is configured to facilitate the
performance of an IGI by a physician 14 on a patient 10. The IGI
system 100 can be utilized for a variety of medical purposes,
including, but not limited to, pacemaker lead placement, coronary
stent placement, cardiac radiofrequency ablation, lung biopsy,
renal stent placement, transjugular intrahepatic porto-systemic
shunting, and/or percutaneous radio frequency ablation of renal
masses, among other procedures. Moreover, the IGI system 100 can be
used to deliver a seal member (e.g., a patch) and/or a sealant to a
body part during such procedures.
[0041] The imaging device 40 (also referred to herein as the
imaging modality or scanner) is coupled to the processor 30. In
some embodiments, for example, the imaging device 40 is
electronically coupled to the processor 30 via a network 50 (e.g.,
a hospital network). The network 50 may be any form of
interconnecting network including an intranet, such as a local or
wide area network, or an extranet, such as the World Wide Web or
the Internet. The network can be physically implemented on a
wireless or wired network, on leased or dedicated lines, including
a virtual private network (VPN).
[0042] The imaging device 40 is configured to take, acquire,
capture, and/or generate an image of at least a portion of the body
of the patient 10, such as a portion including a target anatomy.
The target anatomy can be an internal dynamic anatomy, such as the
heart, lung, blood vessel, or the like. In some embodiments, the
imaging device 40 is configured to take a series of images of the
target anatomy. For example, in some embodiments, the imaging
device 40 is configured to take a set of images of the same portion
of the target anatomy where each image from the set of images is
taken at a different time. In other words, the imaging device 40 is
configured to take a first image of the target anatomy from a first
perspective at a first time, and a second image of the target
anatomy from the first perspective at a second later time. In some
embodiments, the imaging device 40 is configured to concurrently
take a set of images of the target anatomy with each image being
taken from a perspective different than the perspective of the
other images being taken. In this manner, the series of images can
be used to generate a multi-dimensional representation of the
target anatomy.
[0043] The imaging device 40 can be configured to take, acquire,
capture, and/or generate the images pre-operatively,
post-operatively, and/or during the operation. In some procedures,
the images are taken pre-operatively to facilitate the performance
of the procedure using IGI. The imaging device 40 can be configured
to take an image of the body of the patient along more than one
plane. The imaging device 40 can be any suitable 2-D, 3-D, or 4-D
imaging modality. For example, in some embodiments, the imaging
device 40 can be configured as a single-head C-arm fluoroscope (not
shown) configured to take a virtual bi-plane image by rotating the
C-arm about at least two planes, which could be orthogonal planes
to generate two-dimensional images that can be converted to
three-dimensional volumetric images.
[0044] The images can be displayed as 2-D, 3-D, and/or 4-D
representations by the system 100, such as, for example, on a
graphical user interface (GUI) 31 of the processor 30 or other
portion of the system 100. In this manner, and as described in more
detail herein, by acquiring and/or displaying images in more than
one plane, an icon representing the location of a medical
instrument 16 within the body of the patient 10 can be superimposed
on at least one multi-dimensional image when the image is displayed
to the physician 14. For example, in some embodiments, a 4-D
surface rendering of the target anatomy can be achieved by
incorporating patient data or other data from an atlas or
anatomical model map, or from pre-operative image data captured by
the imaging device 40.
[0045] The imaging device 40 can be an imaging device configured
for any suitable imaging modality, such as isocentric fluoroscopy,
bi-plane fluoroscopy, cinematography (CINE) fluoroscopy ultrasound,
high frequency ultrasound (HIFU), intra-vascular ultrasound (IVUS),
computed tomography (CT), optical coherence tomography (OCT),
multi-slice computed tomography (MSCT), magnetic resonance imaging
(MRI), single photon emission computer tomography (SPECT), and/or
positron emission tomography (PET), or any combination thereof.
[0046] For example, MRI is generally performed pre-operatively
using a non-ionizing field. MRI can provide a desired quality of
tissue visualization in 3-D form and can provide anatomical and
functional information from the imaging. MRI data can be registered
and compensated for motion correction using a reference marker, as
described in more detail herein. PET is generally a pre-operative
imaging procedure that can expose the patient to some level of
radiation to provide a 3-D image. PET data can provide functional
information and also can be registered and compensated for motion
correction using a reference marker. CT is also generally a
pre-operative technique that exposes the patient to a limited level
of radiation. CT can be a very fast imaging procedure, at least as
compared to imaging procedures using a different type of imaging
device. A multi-slice CT system can provide a set of 3-D images
having a desired quality of resolution and anatomical information.
CT imaging data generally can be registered and compensated for
motion correction using a reference marker.
[0047] Fluoroscopy is generally an intra-operative imaging
procedure that can expose the patient to a certain amount of
radiation and that can provide 2-D and/or rotational 3-D images.
Fluoroscopic images generally provide a desired quality of
resolution and anatomical information. Fluoroscopic images can be
either manually or automatically registered and can also be
compensated for motion correction using a reference marker.
Ultrasound imaging is also generally an intra-operative procedure
which uses a non-ionizing field to provide either 2-D, 3-D, or 4-D
imaging, including anatomical and/or blood flow information.
Ultrasound imaging provides automatic registration and does not
need to account for any motion correction. Such imaging modalities
are also described in U.S. Patent Publication No. 2006/0025677,
filed Jul. 11, 2005, entitled, "Method and Apparatus for Surgical
Navigation," the entire contents of which is hereby incorporated by
reference.
[0048] In some embodiments, the imaging device 40 includes a hybrid
imaging modality. For example, the imaging device 40 can be a
hybrid of PET and CT. In another example, the imaging device 40 can
be a hybrid of SPECT and CT. The hybrid imaging modality can
provide functional image data superimposed onto anatomical data to
be used to navigate to and/or localize target anatomy within the
patient 10, as described in more detail herein.
[0049] In some embodiments, the imaging device 40 can be a gated
imaging device, such as, for example, an electrocardiogram-gated
(ECG-gated) magnetic resonance imaging (MRI) device and/or an
ECG-gated computed tomography (CT) device. As illustrated in FIG.
1, the monitor 32 (e.g., an ECG monitor) can be attached to the
patient 10 via a set of leads 34 and/or electrodes (not shown). The
monitor 32 and the imaging device 40 are each in electrical
communication with the processor 30. In this manner, the imaging
device 40 is gated based on information received by the processor
from the monitor 32, as described in detail herein. Some bodily
functions, e.g., respiration and circulation, can cause movement of
the target anatomy relative to the medical instrument 16, even when
the medical instrument 16 has not been moved by the physician
and/or relative to a static reference point external to the body of
the patient (e.g., a table 12). Therefore, the imaging device 40
can be configured to acquire the image(s) on a time-gated basis
triggered by a physiological (or physiologically-related) signal.
For example, the physiological signal can be an ECG signal acquired
via the leads 34 (or from a sensing electrode included on the
medical instrument 16 or from a separate reference probe). A
characteristic of this signal, such as an R-wave peak or P-wave
peak associated with ventricular or atrial depolarization,
respectively, may be used to trigger the gate image acquisition
with the imaging device 40.
[0050] Referring to FIGS. 2-3, in some embodiments, the imaging
device 40 is configured to take a set of images (e.g., images I1,
I2, I3 . . . In) of the target anatomy at distinct moments in time
during the anatomy's periodic movement. For example, in some
embodiments, each image of the set of images is taken in rapid
succession. In another example, each image of the set of images can
be taken at intervals over a specified time period. In this manner,
the set of images can include images of the target anatomy during
various stages of the anatomy's periodic movement, such as images
associated with a complete cycle of the anatomy's periodic
movement.
[0051] The imaging device 40 is configured to transmit (or
transfer) the set of images to the processor 30. Similarly stated,
the processor 30 is configured to received the images from the
imaging device 40. In some embodiments, such as when the images are
acquired pre-operatively, the processor 30 stores the received
images in a memory 44 of the processor 30 (see, e.g., FIG. 2). The
processor 30 is also configured to receive data via the converter
26. For example, the processor 30 can be configured to receive data
associated with a periodic human characteristic signal. The
periodic human characteristic signal can be, for example, a phase
or a waveform of an ECG signal received from the patient 10 by the
monitor 32 via the leads 34 coupled to the patient 10 and that is
transmitted to the processor 30. In some embodiments, the human
characteristic signal can be a signal associated with a heart beat,
as shown in FIG. 3.
[0052] The processor 30 is configured to associate at least one
image taken by the imaging device 40 with a sample of the periodic
human characteristic signal to generate a gated signal sample. In
this manner, a set of gated signal samples forms a gated dataset
42. In some embodiments, as illustrated in FIG. 3, each image of
the set of images (represented as images I1, I2, I3, I4 . . . In)
is associated with (or correlated to) a respective periodic human
characteristic signal sample (represented as signal samples S1, S2,
S3, S4 . . . Sn, respectively). In other words, the image I1
corresponds to the image that was taken at a moment of the
patient's 10 ECG cycle that is represented by the signal sample S1.
Similarly, the image I2 corresponds to the image that was taken at
a moment of the patient's 10 ECG cycle represented by the signal
sample S2, the image I3 corresponds to the image that was taken at
a moment of the patient's ECG cycle represented by the signal
sample S3, and so forth. As described in more detail herein, the
gated dataset 42 can be used during the medical procedure for
navigation and/or localization of the medical instrument 16 when
the medical instrument 16 is used on the patient's body. For the
sake of clarity of illustration, the designations of P, Q, R, S,
and T are included in FIG. 3 to identify depolarizations and
re-polarizations of the heart.
[0053] The processor 30 is also configured to receive data
associated with at least one reference marker 18, 22, 24 that is
transmitted to the processor 30. The data from the reference
markers 18, 22, 24 can be transmitted, for example, via at least
one of the tracker 20 and the converter 26. The data can include,
for example, positional information associated with at least one of
the reference markers (e.g., reference marker 18, 22, and/or
24).
[0054] The processor 30 includes a processor-readable medium
storing code representing instructions to cause the processor 30 to
perform a process. The processor 30 can be, for example, a
commercially available personal computer, or a less complex
computing or processing device that is dedicated to performing one
or more specific tasks. For example, the processor 30 can be a
terminal dedicated to providing an interactive GUI 31. The GUI 31
can be configured to display a multi-dimensional representation of
the target anatomy based on the set of images stored in the memory
44. The GUI can also be configured to display a representation (or
icon) 33 of a medical instrument, such as instrument 16,
superimposed on an image of the target anatomy.
[0055] The processor 30, according to one or more embodiments of
the invention, can be a commercially available microprocessor.
Alternatively, the processor 30 can be an application-specific
integrated circuit (ASIC) or a combination of ASICs, which are
designed to achieve one or more specific functions, or enable one
or more specific devices or applications. In yet another
embodiment, the processor 30 can be an analog or digital circuit,
or a combination of multiple circuits. In some embodiments, the
processor 30 includes code with instructions to generate at least a
portion of the gated dataset 42, such as generating at least one
dataset vector associated with at least one image of the set of
images taken by the imaging device 40. In some embodiments, the
software includes code with instructions to choose an image that
represents a current orientation of the live target anatomy
utilizing information in the dataset 42, as described in more
detail herein.
[0056] The processor 30 can include a memory 44 (schematically
illustrated in FIG. 2). The memory 44 can include one or more types
of memory. For example, the memory 44 can include a read only
memory (ROM) component and a random access memory (RAM) component.
The memory 44 can also include other types of memory that are
suitable for storing data in a form retrievable by the processor
30. For example, electronically programmable read only memory
(EPROM), erasable electronically programmable read only memory
(EEPROM), flash memory, as well as other suitable forms of memory
can be included within the memory component. The processor 30 can
also include a variety of other components, such as for example,
co-processors, graphic processors, etc., depending upon the desired
functionality of the code.
[0057] The processor 30 can store data in the memory 44 or retrieve
data previously stored in the memory 44. The components of the
processor 30 can communicate with devices external to the processor
30 by way of an input/output (I/O) component (not shown). According
to one or more embodiments of the invention, the I/O component can
include a variety of suitable communication interfaces. For
example, the I/O component can include, for example, wired
connections, such as standard serial ports, parallel ports,
universal serial bus (USB) ports, S-video ports, local area network
(LAN) ports, small computer system interface (SCSI) ports, and so
forth. Additionally, the I/O component can include, for example,
wireless connections, such as infrared ports, optical ports,
Bluetooth.RTM. wireless ports, wireless LAN ports, or the like.
[0058] The medical instrument 16 can be any suitable device used by
the physician 14 during the IGI. At least a portion of the medical
instrument 16 is configured to be disposed within the body of the
patient. The medical instrument 16 can be any suitable medical
device, including, but not limited to, a catheter, a needle, a
stylet, a probe, a suction tube, an implant, an insert, a capsule,
a sealant delivery device, a guidewire, a stent, a filter, an
occluder, a retrieval device, a camera, a scope, a biopsy tool, a
light source, and/or a lead. The medical instrument 16 can also be
an instrument according to an embodiment, as described in detail
herein. In some embodiments, for example, the medical instrument 16
is configured as a tubular member having a co-axial access path
through which a biopsy needle can be inserted into the patient's
body through the tubular member. For example, the tubular member
can be configured as a co-axial therapy delivery system such that
therapeutic agents can be delivered through the tubular member. In
another example, the medical instrument 16 can be a catheter
configured to be inserted into the right atrium of the patient's
heart by way of the inferior vena cava and/or a femoral artery
access point.
[0059] The tracker 20 is configured to detect (or track) the
positional information of at least one of the reference markers 18,
22, 24. The tracker 20 can be any suitable tracking system,
including, but not limited to, an electromagnetic tracking system.
An example of a suitable electromagnetic tracking system is the
AURORA.RTM. electromagnetic tracking system, commercially available
from Northern Digital Inc. in Waterloo, Ontario, Canada. In some
embodiments, the tracker 20 includes an electromagnetic field
generator configured to emit a series of electromagnetic fields,
which are designed to reach a portion of the body of the patient 10
at which at least one of the reference markers 18, 22, 24 is
disposed. The electromagnetic field can, for example, induce a
voltage in the at least one of the reference marker 18, 22, 24 that
can be monitored and translated into a coordinate position of the
at least one of the reference marker 18, 22, 24. In some
embodiments, the tracker 20 includes a localizer (not shown), such
as an optical, an acoustic, or another localizer depending upon the
system for which the localizer is chosen. In some embodiments, the
tracker 20 includes a transmitter coil array and/or a coil array
controller.
[0060] The reference marker 18, also referred to herein as an
instrument reference marker, is configured to be detected by the
tracker 20. The reference marker 18 is disposed on and/or coupled
to the medical instrument 16 in a known position. In this manner, a
position, orientation, and/or location of the reference marker 18
(also referred to herein at the position or the positional
information) as detected by the tracker 20 can be associated with a
position of the medical instrument 16 with respect to the body of
the patient 10. The positional information associated with the
location, orientation, and/or position of the reference marker 18,
and thus the medical instrument 16, can be identified by the
tracker 20 and transmitted to at least one of the converter 26 and
the processor 30. The reference marker 18 can be any suitable
marker configured to be detected by the tracker 20. In some
embodiments, for example, the reference marker 18 is or includes a
coil, or an electromagnetic coil specifically, configured to
receive an induced voltage, which voltage can be detected by the
tracker 20.
[0061] The reference marker 22, also referred to herein as an
external reference marker, is configured to be disposed at a
location that is proximate to the target anatomy and that exhibits
no or negligible movement with respect to the patient's heartbeat
and/or respiration. In other words, the reference marker 22 is
configured to be disposed at a static location. For example, in
some procedures, the reference marker 22 can be securely fixed to a
table 12 upon which the patient 10 is secured. In some procedures,
for example if the patient 10 is not secured to the table 12, the
reference marker 22 can be disposed on a portion of the patient's
10 static anatomy (e.g., a region of the patient's back). A
position, location, and or orientation of the reference marker 22
is configured to be tracked by the tracker 20, as described herein.
The reference marker 22 can be any suitable reference marker, such
as any of the types of reference markers described herein.
[0062] The reference marker 24 is configured to be disposed in the
region of the patient's body where the IGI will be performed.
Specifically, the reference marker 24 is configured to be disposed
at an anatomic location within the body of the patient 10 that
exhibits movement correlated to and/or associated with a movement
of the target anatomy (i.e., the anatomy intended for IGI). In some
embodiments, the reference marker 24 is configured to be disposed
at a location internal to the body of the patient. A position,
location, and/or orientation of the reference marker 24 is
configured to be detected by the tracker 20, as described herein.
In some embodiments, the reference marker 24 can be any suitable
reference marker, such as any of the types described herein. In
some embodiments, for example, the reference marker 24 is a
non-tissue internal reference marker, also referred to as a
"fiducial," that is positioned within the body of the patient 10
and that is not made from the patient's bodily tissue.
[0063] Referring again to FIG. 1, at least one of the medical
instrument 16, the reference markers 18, 22, 24, and/or the tracker
20 is couplable to the converter 26 of the system 100. The
converter 26 is configured to receive a measurement, e.g., an
analog measurement, from at least one of the reference markers 18,
22, 24 and/or the tracker 20. The converter 26 is configured to
convert the analog measurement into digital data that can be
received and/or processed by the processor 30, which is couplable
to the converter 26. The converter 26 is also configured to
transmit the digital data to the processor 30. The converter 26 can
be, for example, a break-out box. In some embodiments, the
converter 26 includes an isolator circuit, such as an isolator
circuit of the type that may be included in a transmission line or
a line carrying a signal or a voltage to another portion of system
100 (e.g., the processor 30). In some embodiments, the converter 26
is configured to electronically isolate at least the portion of the
medical instrument 16 that is in contact with the patient 10 should
an undesirable electrical surge or voltage occur. Although the
converter 26 is illustrated as a distinct portion of system 100, in
some embodiments, the converter is included in the processor 30,
the medical instrument 16, and/or another suitable portion of
system 100.
[0064] The monitor 32 is configured to be coupled to the body of
the patient 10 and to the processor 30. The monitor 32 is
configured to receive and/or monitor a periodic human
characteristic signal from the patient 10. The periodic human
characteristic signal can be, for example, a signal associated with
at least one of heart beat and/or respiration. An example of a
human characteristic signal is shown in FIG. 3. As illustrated in
FIG. 1, the monitor 32 can be an ECG monitor configured to receive
an ECG signal in the form of an ECG data transmitted to it by an
ECG lead 34 coupled to the patient 10. In some embodiments, the
monitor 32 is configured to transmit the periodic human
characteristic signal (e.g., the ECG data) to the processor 30.
[0065] In preparation for conducting the IGI procedure, the
reference marker 24 is placed in the gross anatomical region of
interest for the procedure. After placement of the reference marker
24, a series of images of at least a portion of the body of the
patient 10 is taken, produced, captured, and/or generated with the
imaging device 40. The gated dataset 42 generated by the imaging
device 40 is transferred to the processor 30. Optionally, at this
point in the procedure, the patient 10 can be secured to operating
table 12 and/or to portions of the system 100, including, for
example, the tracker 20, the converter 26, the processor 30, the
monitor 32, and/or the imaging device 40. The software of the
processor 30 can begin an operation sequence. In some embodiments,
the software first enters a Calibration State, as described
below.
[0066] FIG. 4 is a flow chart of a method 60 of performing the
Calibration State. Although the activities of method 60 can be
performed with any suitable system, for the sake of illustration,
the activities of method 60 are described herein with reference to
system 100 and FIGS. 1-3.
[0067] Referring to FIG. 4, the method 60 includes loading a gated
dataset into a memory, 62. For example, referring to the system
100, in some embodiments, the code and/or software includes
instructions to load the gated dataset 42 into the memory 44 of the
processor 30. The method 60 optionally includes generating the
gated dataset. The gated dataset can be generated by the imaging
device, monitor, and/or processor, as shown and described
above.
[0068] The method 60 also optionally includes looping through each
gated signal sample, 64, and sampling a live periodic human
characteristic signal, 66. For example, in some embodiments, the
method includes looping through each gated signal sample S1, S2, S3
. . . Sn while a live periodic human characteristic signal is
sampled and/or received from patient 10 via the monitor 32. The
signal can be, similar to the periodic human characteristic signal
used in generating the gated dataset 42 such as an ECG signal or
waveform. In other words, a live ECG waveform can be sampled with
respect to each gated signal sample used to construct the gated
dataset.
[0069] The method 60 includes comparing the live periodic human
characteristic signal sample to the gated dataset, 68. For example,
referring to FIGS. 1-3, in some embodiments, the method includes
comparing the live periodic human characteristic signal (e.g., the
ECG waveform) sample of the patient 10 to a gated signal sample Si
(e.g., sample S1, S2, or Sn) of the gated dataset 42. If the live
periodic human characteristic signal matches the gated signal
sample Si, the method continues, for example, to activity 70. If
the live periodic human characteristic signal sample does not match
the gated signal sample of the gated dataset 42, activities 64, 66
and 68 are repeated, for example, until a matching gated signal
sample is detected. As used herein, the live periodic human
characteristic signal is said to match the gated sample when the
periodic human characteristic signal previously acquired is
substantially equal to the live periodic human characteristic
signal. A match can be ascertained using a signal processing
technique that, in the case of an ECG waveform, examines historical
waveform amplitudes. A match can occur, for example, when certain
coordinates or other data associated with the samples to determine
if the live sample and the gated sample are sufficiently equivalent
for purposes of the IGI.
[0070] When the comparison of the live sample and the gated sample
meets a specified criteria, the method 60 includes receiving a
position of an external reference marker and a position of an
internal reference marker, 70. For example, referring to the system
100, in some embodiments, the tracker 20 is polled for the position
information after the live periodic human characteristic signal
sample is matched to the gated signal sample. In some embodiments,
the software queries the tracker 20 for the reference marker (e.g.,
reference marker 22, 24) positional information and the information
is received by the processor 30.
[0071] The method 60 includes generating, calculating, and/or
constructing a dataset vector associated with the positional
information of the external reference marker and positional
information of the internal reference marker, 72. Such positional
information is also referred to herein as the tracking space
coordinates. Referring to the system 100, in some embodiments, the
code and/or software of the processor 30 can calculate a dataset
vector Vi using the positional information of the external
reference marker 22 and the internal reference marker 24. FIG. 4A
shows a schematic illustration of a dataset including the dataset
vector Vi. For example, each dataset vector can be characterized by
a magnitude and a direction generated using data associated with
the positional information of the external reference marker 22 and
data associated with the positional information of the internal
reference marker 24. Thus, the positional information of the
external reference marker 22 can be characterized as an origin and
the positional information of the internal reference marker 24 can
be characterized as an end-point for a dataset vector that begins
at the origin and ends at the end-point. In some embodiments,
multiple internal reference markers are disposed within the body of
the patient, thus multiple vectors may be generated.
[0072] The method 60 includes associating the dataset vector with
an image that corresponds to (or that is associated with) the gated
signal sample, 74. In some embodiments, a processor (e.g.,
processor 30) and/or a software program can store the dataset
vector in a look-up table with a pointer to an image Ii (e.g.,
Image I1, I2 . . . In) that corresponds to the gated signal sample
Si of gated dataset 42. For example, FIG. 4A shows a schematic
illustration of a look-up table including the image Ii. In other
words, the dataset vector is associated with a particular image Ii,
thus the image can be referred to as a mapped image.
[0073] Optionally, the method 60 includes repeating the looping 64,
the sampling 66, the matching 68, the receiving 70, the generating
72, and/or the associating 74 until each activity has been
performed for each gated signal sample, and thus resulting in a set
of dataset vectors stored in the look-up table. Each dataset vector
of the set of dataset vectors is associated with an image that
corresponds to the gated signal sample. Optionally, upon completion
of activities 64 through 74 for each gated signal sample, the
periodic human characteristic signal monitor 32 (e.g., ECG monitor)
can be turned off or otherwise decoupled (or disconnected) from the
system 100.
[0074] The method also includes performing a transformation
calculation. In this manner, the method 60 also includes, for each
dataset vector in the look-up table, examining each mapped image,
75. For example, each mapped image can be analyzed to identify data
associated with the positional information of at least one of the
external reference marker and the internal reference marker used to
create the dataset vector with which the mapped image is
associated.
[0075] The image space coordinate of the internal reference marker
in each image is determined, 76. The image space coordinates can
include, for example, voxel, volumetric pixel, and/or another
suitable coordinate. For example, referring to system 100, the
processor 30 can perform a segmentation procedure to identify the
actual position data associated with the reference markers 22, 24
within the image dataset. Segmentation is the process of
identifying reference points in the 3-D image dataset. The purpose
of the segmentation is to automatically locate potential
"landmarks" in the dataset that indicate a location where a
reference marker 22, 24 may be located. Segmentation can be
performed in a variety of different manners, as described in detail
in the `799 Application. In some embodiments, the image Ii
undergoes a thresh-holding segmentation during which the processor
30 determines (or finds) the image space coordinate of the internal
reference marker 24 in the image Ii. In another example, the
processor 30 can perform an automated segmentation procedure. For
example, an automatic segmentation process can include, intensity
filtering, connectivity analysis, and size and shape filtering to
identify candidate marker locations, or image space coordinates of
the marker candidates.
[0076] After the segmentation process is performed, an automatic
correlation process can be performed. Correlation as used here is
the process of matching and/or associating reference points between
the image space and the tracking space. Matching and/or associating
the reference points can aid in accurately computing the
registration between the data in the image space and the data in
the tracking space without user interaction. The correlation
process determines where each of the reference markers 22, 24 (or a
localization element coupled to each reference marker 22, 24) is
positioned in the images. The correlation process can be used in
the computation of a transformation between image space and
tracking space. The apparatuses and methods described herein enable
the correlation process to be automated with minimal user
intervention. Automatic correlation results in an association of
the location of the markers (e.g., reference markers 22, 24) in
image space and tracking space, as well as the corresponding
labeling/identification of each marker in each space.
[0077] After the correlation process, the processor 30 can perform
an automatic registration process. The process of registration
tracks temporal movement of the dynamic body part via the movement
of the reference markers 22, 24. When temporally valid, the
automatic registration process can compute the transformation
between the tracking space and the image space. Thus, as
illustrated in FIG. 4, the method 60 also includes calculating a
transformation between the tracking space and the image space using
the positional information of the external reference marker and the
internal reference marker, 78. For example, in some embodiments,
once the image space coordinate of the internal reference marker 24
is known, the positional information (e.g., the tracking space
positions) of the external reference marker 22 and the internal
reference marker(s) 24 received at activity 70 is used to calculate
a transformation Ti between the tracking space and the image space.
The transformation Ti can be calculated, for example, using a least
squares method.
[0078] The method 60 includes associating the transformation with
the image in question, 80. For example, the transformation Ti can
be associated (or linked) to the image Ii. As such, the look-up
table includes a dataset that includes the pre-operative images, at
least one of the images (and, in some embodiments, each image)
depicting the internal reference marker 24, being linked to a
dataset vector and a transformation, and being at least 2-D.
[0079] FIG. 5 is a flow chart of a method 90 of performing the
Navigation State. Although the activities of method 90 can be
performed with any suitable system, for the sake of illustration,
the activities of method 90 are described herein with reference to
system 100 and FIGS. 1-3.
[0080] In the Navigation State, the method 90 can include an
infinite loop of events, 92. The method includes receiving a
current position of an external reference marker and a current
position of an internal reference marker, 94. As used herein,
"current" does not necessarily imply that the position of the
external reference marker and the position of the internal
reference marker are sampled and/or received at the same time
(e.g., simultaneously and/or instantaneously), rather, the term
"current" is used to differentiate between the positions received
at this activity from the positions received at a previously
completed activity, for example. For example, the processor 30 can
obtain the position information as described above with respect to
method 60, which can be different than the positional information
received at activity 92.
[0081] Referring to FIG. 5, the method 90 includes constructing a
current vector, 96. For example, in some embodiments, the method
can include constructing a current vector using the current
positions of the external reference marker and the internal
reference marker received at activity 94. The method 90 includes
comparing the current vector to the dataset vectors, 98. For
example, in some embodiments, the software compares the current
vector to the dataset vectors (e.g., V1, V2 . . . Vn) to determine
the dataset vector associated with the current vector being
analyzed. The generation of the dataset vectors is described above
with reference to method 60 and FIG. 4A.
[0082] The method 90 also includes determining whether the current
vector matches the dataset vector, 101. If the current vector does
not match the dataset vector, the comparing of the current vector
to the dataset vectors and the determining of the matching is
repeated, e.g., until the current vector matches the dataset
vector. If the current vector does match the dataset vector, the
matching look-up table dataset vector (Vi) (or tracking space
coordinates) is defined as the match dataset vector (MDV).
[0083] The method 90 includes loading an image from the gated
dataset pointed to by (or associated with) the MDV, 102. Referring
to the system 100, for example, in some embodiments, the method
includes loading into the memory 44 of the processor 30 the image
from the gated dataset 42 that is associated with (or pointed to
by) the MDV.
[0084] Optionally, the method 90 includes loading the
transformation associated with the MDV and the correlated image,
104. For example, in some embodiments, the method includes loading
into the memory 44 of the processor 30 the transformation Ti
associated with the MDV Vi and the correlated image li.
[0085] The method 90 includes receiving the current position of the
instrument reference marker, 106. In some embodiments, referring to
the system 100, for example, the processor 30 can receive the
position of instrument reference marker 18 from the tracker 20
obtain (e.g., via the converter 26).
[0086] The method 90 also includes applying a transformation to the
position of the instrument reference marker, 108. The
transformation can be a transformation procedure as described above
with reference to method 60. In some embodiments, the position of
the instrument reference marker is transformed into image space.
For example, in some embodiments, the software of the processor 30
applies the transformation Ti to the position of the instrument
reference marker 18 to transform that position into image
space.
[0087] The method 90 includes superimposing a representation of the
instrument on the image, 110. For example, referring to FIG. 1, in
some embodiments, the software of the processor 30 superimposes
(e.g., renders, draws, or the like) a representation 33 (e.g., an
iconic representation) of the medical instrument 16 on the selected
image Ii displayed on the GUI 31 of processor 30.
[0088] Optionally, the activities of method 90, e.g., of the
Navigation State, can be repeated. Repeated performance of the
activities of method 90 can, for example, provide the physician 14
with a live representation of the medical instrument 16 with
respect to the live position and orientation of the target anatomy,
thus facilitating guidance of the medical instrument 16 to a
desired location within the body of the patient, e.g., to deliver
medical therapy and/or perform a medical procedure.
[0089] A system 200 according to an embodiment is illustrated in
FIG. 6. The system 200 is configured to be used in performing and
IGI using an imaging modality, such as CINE 2-D fluoroscopy, that
can be utilized within the operating theater during the medical
procedure. In this manner, the physician 14 need not gate the
periodic human characteristic signal to a pre-operative image, as
described above with reference to system 100.
[0090] The system 200 is similar in many respects to system 100,
except that the system 200 does not include association with the
network 50. The imaging device is illustrated in FIG. 6 as a
fluoroscope 215. The medical instrument 16, the reference markers
18, 22, 24, the converter 26, the monitor 32, and the processor 30,
are configured to be coupled and in communication as described
above. In some embodiments, the processor 30 includes software
instead of or in addition to the software described above. For
example, in some embodiments, the processor 30 includes software
that comprises code providing instructions to perform a Calibration
State 250 and/or a Navigation State 350 utilizing a fluoroscopy
imaging modality, as described in more detail herein.
[0091] The fluoroscope 215 is coupled to the processor 30. The
fluoroscope 215 includes a stand 210, a receiver unit 212 (e.g., a
fluoroscope radiation receiver unit), and a calibration jig 214.
The calibration jig 214 is couplable to the receiver unit 212. The
fluoroscope 215 is configured to take at least one image of the
target anatomy of the patient 10. For example, referring to FIG. 7,
the fluoroscope 215 can be configured to take a set of images I1,
I2 . . . In of the target anatomy.
[0092] The internal reference marker, placed within the body as
described above, is tracked by the tracker 20 as each image of the
set of images I1, I2 . . . In is taken, produced, and/or generated
with the fluoroscope 215. The placement of the internal reference
marker 24 is illustrated in FIG. 7 with respect to the heart, and
more specifically, with respect to various stages of the heart's
function (A1, A2 . . . An). The vector (V1, V2 . . . Vn), described
in more detail herein, can be determined based on the positions of
each of the external reference marker (not shown) and the internal
reference marker 24, as illustrated in FIG. 7 in terms of the X, Y,
and Z axis information. Once the image is taken, an image most
accurately depicting the target anatomy (e.g., the heart) at a
particular moment in time can be ascertained by viewing the
position of the internal reference marker 24 and selecting the
image that was taken when the internal reference marker 24 was last
in that particular location and orientation.
[0093] To begin the IGI, the patient 10 can be placed upon the
table 12. Optionally, an ECG monitor 32 can be connected to the
patient 10 for diagnostic purposes unrelated to performing image
guidance. The fluoroscope 215 is positioned to allow images to be
taken of patient 10. The physician 14 can select the appropriate
orientation of the patient 10, such as a orienting the patient to
obtain a Right Anterior Oblique (RAO) view. The physician 14 can
place the external reference marker 22, as described above, at a
location that exhibits no or minimal movement with respect to the
patient's 10 heartbeat and/or respiration.
[0094] FIG. 8 is a flow chart of a method 250 (e.g., a Calibration
State) according to an embodiment. Although the activities of
method 250 can be performed with any suitable system, for the sake
of illustration, the activities of method 250 are described herein
with reference to system 200. The method 250 includes receiving a
live video feed from the fluoroscope, 252. For example, in some
embodiments, the physician 14 can cause the fluoroscope 215 to
begin acquiring an image signal (e.g., a CINE fluoroscopy loop). As
the fluoroscope 215 begins to acquire the image signal, the live
video feed can be sent to, and received by, the processor 30.
[0095] The method 250 includes sampling an image from the live
video feed, 254. For example, in some embodiments, while the
fluoroscope 215 is acquiring the CINE loop the method can include
sampling the live video feed. In some embodiments, the sampling can
occur at a rate greater than 30 Hz so as capture a number of images
(e.g., image frames) that, when pieced together, appear to be a
real time image 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.
[0096] The method 250 includes storing an image in memory, 256. The
memory can be similar in many respects to memory 44, described
above. In some embodiments, the method includes producing an image
Ii, such as an image frame illustrated in FIG. 7, and storing that
image into the memory 44 of the processor 30.
[0097] The method 250 includes receiving a position of a reference
marker, 258. The receiving the position of the reference marker can
be performed in a similar manner as described above with respect to
method 60. In some embodiments, for example, the method can include
receiving positional information associated with at least one of
the reference markers 22, 24 from the tracker 20.
[0098] The method 250 includes constructing a dataset vector using
the positional information of the reference markers, 260. For
example, in some embodiments, the method includes constructing
and/or calculating, a dataset vector Vi (e.g., dataset vector V1,
V2 . . . Vn) that defines the orientation of the reference markers
22, 24 during the time of acquisition of the image Ii.
[0099] The method 250 also includes recording the dataset vector
and the associated image in a dataset, 262. For example, as shown
in FIG. 4A, in some embodiments, the method includes recording the
dataset vector Vi and the associated image Ii in a dataset 300. The
dataset 300 can include, for example, a look-up table, as
illustrated in FIG. 9 and described below. The dataset 300 can
reside in the memory 44 of the processor 30. In some embodiments,
the dataset 300 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.
[0100] Referring to FIG. 8, the software can initiate a
transformation calculation process, e.g., for each image in a set
of images, 263, after the set of images have been collected and/or
stored. For example, the transformation can be implemented as
described above with respect to method 60. In another example, the
method 250 includes receiving a position of the calibration jig,
264. For example, referring to system 200, the code and/or software
of processor 30 includes code comprising instructions to receive
positional information associated with the position of the
calibration jig 214 for each image Ii. In some embodiments, the
software polls the tracker 20 for and receives from the tracker 20
the positional information of the calibration jig 214.
[0101] The method 250 includes calculating a transformation using
the calibration jig positional information and the database vector,
266. In some embodiments, the software calculates a transformation
Ti from a tracking space (e.g., the tracker field coordinate space)
to image space (e.g., the fluoroscope image space) using the
methods disclosed herein.
[0102] The method 250 also includes storing the transformation with
the image, 268. For example, in some embodiments, the
transformation Ti is stored in association with (e.g., linked to)
the image Ii in the look-up table associated with the database
vector Vi. In this manner, the transformation Ti is associated with
the image li. The activities of method 250 can be repeated, for
example, until the periodic cycle of movement of the target anatomy
is captured by the images taken.
[0103] FIG. 9 is a flow chart of a method 350 according to an
embodiment. The method 350 includes performing a Navigation State,
which can be initiated by the code and/or software of the processor
30. Although the activities of method 350 can be performed with any
suitable system, for the sake of illustration, the activities of
method 350 are described herein with reference to system 200. In
the Navigation State 350, the software can enter an infinite loop
of activities, 352.
[0104] The method 350 includes receiving a current position of at
least two reference markers, 354. The position information can be
received, for example, in a manner similar to the receiving 94
described above with respect to method 90. In some embodiments, the
processor 30 can receive positional information associated with the
at least two reference markers from the tracker 20 via the
converter 26. The processor can receive current position
information, for example, that is associated with the position of
each of the external reference marker 22 and the internal reference
marker 24.
[0105] Referring to FIG. 9, the method 350 includes generating (or
constructing) a current vector using the current positions, 356.
The generating 356 can be implemented in a similar manner as the
constructing 96 described above with respect to method 90. For
example, the processor can construct a current vector using the
received current positions of the external reference marker 22 and
the internal reference marker 24.
[0106] The method 350 includes comparing the current vector to the
dataset vectors, 358. The comparing 358 can be implemented in a
similar manner as the comparing 98 described above with respect to
method 90. For example, in some embodiments, the method includes
comparing the current vector to the dataset vectors (e.g., V1 . . .
Vn) to determine the dataset vector associated with the current
vector being analyzed. In some embodiments, the method includes
comparing the current positions of each of the external reference
marker 22 and the internal reference marker 24 to the tracking
space coordinates.
[0107] The method 350 includes determining as to whether the
current vector matches the dataset vector, 360. The determining 360
can be implemented in a similar manner as the determining 101
described above with respect to method 90. If the current vector
does not match the dataset vector, the comparing of the current
vector to the dataset vectors and the determining of the matching
is repeated, e.g., until the current vector matches the dataset
vector. If the current vector does match the dataset vector, the
matching look-up table dataset vector (Vi) (or tracking space
coordinates) is defined as the match dataset vector (MDV).
[0108] The method 350 also includes loading an image from the
dataset that is associated with the dataset vector, 362. The
loading 362 can be implemented in a similar manner as the loading
102 described above with respect to method 90. For example,
referring to system 200, in some embodiments, the method includes
loading into the memory 44 of the processor 30 the image Ii from
dataset 300 associated with (or pointed to by) the MDV (Vi).
[0109] Referring to FIG. 9, the method 350 optionally includes
loading a transformation linked to the image, 364. The loading 364
can be implemented in a similar manner as the loading 104 described
above with respect to method 90. For example, in some embodiments,
the method includes loading into the memory 44 of the processor 30
the transformation Ti associated with the MDV Vi and the correlated
image Ii.
[0110] The method 350 includes receiving the current position of
the instrument reference marker, 366. The receiving 366 can be
implemented in a similar manner as the receiving 106 described
above with respect to method 90. In some embodiments, for example,
the method includes receiving the position of instrument reference
marker 18 from the tracker 20.
[0111] The method 350 includes applying a transformation to the
position of an instrument reference marker, 368. The transformation
can be a transformation procedure as described above with reference
to method 60. In some embodiments, the position of the instrument
reference marker 18 is transformed into image space. For example,
in some embodiments, the code and/or software of the processor 30
applies the transformation Ti to the position of the instrument
reference marker 18 to transform the position of the instrument
reference marker 18 into image space.
[0112] The method 350 includes superimposing a representation of
the instrument on the image, 370. The superimposing 370 can be
implemented in a similar manner as the superimposing 110 described
above with respect to method 90. For example, referring to FIG. 6,
in some embodiments, the code and/or software of the processor 30
superimposes (e.g., renders, draws, produced, or the like) a
representation (e.g., an iconic representation) of the medical
instrument 16 on the selected image Ii displayed on the GUI 31 of
processor 30.
[0113] Optionally, the activities of method 350, e.g., of the
Navigation State, can be repeated. Repeated performance of the
activities of method 350 can provide the physician 14 with a
representation of the medical instrument 16 with respect to the
live position and orientation of the target anatomy, thus
facilitating guidance of the medical instrument 16 to a desired
location within the body of the patient, e.g., to deliver medical
therapy and/or perform a medical procedure.
[0114] Although the methods illustrated and described herein
include automatic registration of the images, in other embodiments,
the images can be registered with a different registration process.
For example, in other embodiments, the images can be registered
using point registration, surface registration, pathway
registration, auto-registration, or the like, or any combination
thereof.
[0115] Although the systems (e.g., systems 100, 200) and the
methods (e.g., methods 60, 90, 250, 350) have been illustrated and
described as including and with respect to a single internal
reference marker 24, in other embodiments, a system and/or a method
can include any suitable number of reference markers, e.g., two,
three, or more reference markers.
[0116] The reference marker 24 can be similar in many respects to
the reference marker 400 shown and described below with reference
to FIG. 10. The reference marker 400 includes a body portion 410, a
fixation member 414, and a channel portion 416. The body portion
410 defines a chamber 412. The chamber 412 is configured to receive
at least a portion of a medical device, such as a sensor 420. The
body portion 410 of the reference marker 400 is configured to be
opaque to the imaging device 40. In other words, the body portion
410 is configured to be visible (e.g., as a blank or white spot) on
an image of a portion of the body of the patient including the
reference marker 400 taken produced, and/or generated using and
imaging device (e.g., imaging device 40). For example, the body
portion 410 can be constructed of a material that is opaque to the
imaging device 40. In some embodiments, the body portion 410 is
constructed of platinum, titanium, or the like, or the like, or any
suitable combination thereof.
[0117] The fixation member 414 is coupled to the body portion 410.
The fixation member 414 is configured to facilitate retention of
the reference marker 400 within the body of the patient (not
shown). Similarly stated, the fixation member 414 is configured to
limit movement of the body portion 410 relative to the body of the
patient. As illustrated in FIG. 10, the fixation member 414 has a
pig-tail shape. In this manner, the fixation member 414 is
configured to be screwed into a portion of the patient's body
(e.g., in bone and/or cartilage) and/or unscrewed to release the
reference marker 400 from the patient's body, such as after
completion of the procedure. Although the fixation member 414 of
the reference marker 400 is illustrated and described herein as
having a pig-tail shape, in other embodiments, the fixation member
can have any suitable configuration for retaining the reference
marker within the body of the patient.
[0118] The channel portion 416 of the reference marker 400 is
coupled to the body portion 410. The channel portion 416 defines a
passageway 418 that is in fluid communication with the chamber 412
of the body portion 410. The channel portion 416 is configured to
receive at least a portion of a medical device, such as sensor 420.
The channel portion 416 can include, for example, a sheath or a
portion of a sheath. The channel portion 416 can be constructed of
any suitable material, including, for example, plastic.
[0119] The channel portion 416 can be of any suitable configuration
(e.g., length, circumference, etc.). In some embodiments, for
example, the channel portion 416 can have a length such that the
channel portion 416 is configured to extend from a location within
the body of the patient to a location exterior to the body of the
patient. In this manner, the sensor 420 (or other medical device)
can be inserted into the passageway 418 of the channel portion 416
outside of the body of the patient and delivered to the chamber 412
of the body portion 410 of the reference marker 400 after
implantation of the reference marker 400 within the body of the
patient. In some embodiments, the sensor 420 can be inserted into
the chamber 412 after images of the target anatomy have been taken
to generate the gated dataset 42. For the sake of clarity, as used
herein, references to the reference marker 400 should be construed
as references to those portions of the reference marker that are
disposed within the body of the patient during a given IGI.
[0120] The sensor 420 can include at least one connecting lead 422
configured to facilitate disposing the sensor 420 in the chamber
412. The sensor 420 and/or the connecting leads 422 can be secured
in place with respect to the chamber 412. In some embodiments, at
least one of the sensor 420 and the lead 422 can be constructed of
a ferrous material. In other embodiments, however, because the
sensor 420 and/or lead 422 can be inserted into the chamber 412 of
the body portion 410 of the reference marker 400 after generation
of the gated dataset 42 (and thus after imaging by the imaging
device 40), the sensor 420 and/or lead 422 need not be constructed
of a non-ferrous material.
[0121] In use, the chamber 412 is implanted within the body of the
patient, e.g., prior to imaging with the imaging device 40. At the
time of implantation, the chamber 412 of the reference marker 400
can be empty. After implantation, the reference marker 400 can be
imaged (or scanned) with the imaging device 40, such as when the
imaging device 40 is taking pre-operative images of the target
anatomy. Upon completion of the imaging, the sensor 420 (or other
medical device) is inserted through the passageway 418 until at
least a portion of the sensor 420 is disposed within the chamber
412 of the body portion 410 of the reference marker 400.
[0122] Each of the body portion 410 and the fixation member 414 can
be constructed of any suitable material configured to be disposed
within a body of a patient and/or configured to be used with an
imaging device (e.g., a gated scanner 40). In some embodiments, for
example, at least one of the body portion 410 and the fixation
member 414 is constructed of a non-ferrous material. In this
manner, the reference marker 400 is configured to comply with
safety requirements of certain imaging modalities, such as an MRI
device. In other words, the body portion 410 of the reference
marker 400 can be constructed of a material suitable for imaging
with the imaging device 40, while the sensor 420 can be constructed
of a material suitable for being detected by the tracker 20 (and
which may or may not be suitable for imaging with the imaging
device).
[0123] Although portions of the systems (e.g., systems 100, 200)
are illustrated and described herein as being distinct from other
portions of the system (e.g., system 100, 200), in some
embodiments, a portion of the system may be incorporated into
another portion of the system. For example, in some embodiments,
portions of the system (e.g., the tracker 20 and/or the processor
30 of systems 100, 200) can be incorporated into the imaging device
40. In this manner, an integrated imaging and tracking system can
be provided.
[0124] Although the imaging device 40 has been illustrated and
described as being and ECG-gated imaging device, in other
embodiments, the system can include an imaging device having a
different gated configuration. In other words, the system can be
gated with a different periodic human characteristic signal. For
example, in some embodiments, the gate triggering event (or the
period human characteristic signal) can be a
physiologically-related signal associated with the patient's 10
respiration or hemodynamics. For example, a sensor regarding
respiration may be used to trigger the acquisition of the images at
the same point in the respiration cycle. A sensor can be coupled to
the system 100, such as an external capnographic sensor that
monitors exhaled CO.sub.2 concentration and/or an airway pressure
sensor, that is configured to determine the end expiration point.
The respiration, both ventriculated and spontaneous, can cause an
undesirable elevation or reduction, respectively, in a baseline
pressure signal, which can be used to trigger acquisition of the
image(s). By measuring systolic and diastolic pressures at the end
expiration point, the coupling of respiration noise is
minimized.
[0125] Furthermore, any suitable imaging modality configured to be
gated to a periodic human characteristic signal may be used in
performance of the methods described herein, including, but not
limited to CT, MRI, CINE fluoroscopy, positron emission tomography
(PET), ultrasound, and functional MRI (fMRI).
[0126] In another example, although method 60 has been illustrated
and described as generating the dataset vector associated with the
position and/or location of the external reference marker and/or
the position and/or location of the internal reference marker, 72,
in some embodiments, the generated dataset vectors include only the
positional coordinates of the external reference marker and the
internal reference marker, thus the generating the dataset vector
need not be performed and the associating of the dataset vectors to
the various images of gated dataset includes associating the
positional (or tracking space) coordinates of the relevant
reference markers to those images. Similarly, although method 90
has been illustrated and described as comparing the current vector
to the dataset vectors, 98, in some embodiments, the current
positions of the external reference marker and the internal
reference marker are compared to the tracking space
coordinates.
[0127] The systems (e.g., system 100, system 200) and methods
(e.g., methods 60, 90, 250, 350) described herein can be used in
performing a variety of medical procedures using ICI. For example,
in some embodiments, a system (e.g., system 100, system 200) and/or
a method (e.g., methods 60, 90, 250, 350) described herein is used
to deliver a sealant to a body of a patient. In some embodiments,
for example, the medical instrument 16 is used in conjunction with
a navigation system (e.g., system 100, 200) according to an
embodiment to deliver the sealant to the body of the patient.
[0128] A medical instrument 500 configured to deliver a sealant to
a body of a patient according to an embodiment is illustrated in
FIG. 11. For example, the instrument 500 can be configured to
deliver at least one surgical sealant, including, but not limited
to a fibrin sealant, thrombin, fibrinogen, a cyanocrylate, collagen
(or a collagen-based compound), a cross-linker, an aldehyde, and/or
a hydrogel, or the like, or any combination thereof A suitable
sealant for a particular procedure can be selected, for example,
based on certain properties of the sealant. Such properties can
include, for example, the strength of the sealant; whether the
sealant is biodegradable; the degree, if any, to which the sealant
facilitates natural healing of a bodily wound; the sealant's
barrier against infection; and/or the ease of use of the
sealant.
[0129] For example, in some embodiments, the instrument 500 can
deliver a fibrin sealant, which can include thrombin and
fibrinogen, may have suitable properties for the procedure to be
performed, such as, for example, properties related to tissue
adhesion and/or hemostasis. The materials included in the fibrin
sealant can be of any suitable origin, e.g., human plasma, bovine,
or another suitable source. The fibrin sealant also can be
configured to promote healing of a bodily wound. In some
embodiments, and as described in more detail herein, fibrin sealant
can be delivered to a puncture site formed within the lung to seal
the lung. In some embodiments, the fibrin sealant can be delivered
to the body of the patient as a liquid. In other embodiments, in
other embodiments, the fibrin sealant can be delivered to the body
of the patient as a slurry, suspension, paste or the like.
[0130] In another example, the instrument 500 can deliver a sealant
including a cyanoacrylate, which can be configured to form a seal
within the body of the patient for a period of about seven to ten
days. The cyanocrylate sealant can be substantially water-proof
and/or water-resistant, have a high strength (e.g., a strength
greater than the fibrin sealant), and/or be non-bioresorbable. In
some embodiments, the cyanocrylate sealant is configured to stop
bleeding at the portion of the patient's body on which the sealant
is disposed. For example, the sealant can include a coagulant. In
some embodiments, the cyanocrylate sealant can be delivered to the
body of the patient via a substrate.
[0131] In yet other embodiments, the instrument 500 can deliver a
sealant including a collagen and/or a collagen-based compound. In
some embodiments, the collagen-based sealant is configured to
deliver fibrinogen to the body of the patient. The sealant can
include any suitable known collagen-based compound, including, but
not limited to FloSeal, commercially available from Sulzer Spine
Tech, Proceed, commercially available from Fusion Medical
Technologies, and Costasis, commercially available from Cohesion
Technologies.
[0132] In yet other embodiments, the instrument 500 can deliver a
sealant including an aldehyde, such as gluteraldehyde. In some
embodiments, the aldehyde sealant is configured to fill an opening
within the patient's body, such as a puncture site. In some
embodiments, the aldehyde sealant is configured to be delivered to
the body of the patient as a liquid. In some embodiments, the
aldehyde sealant is configured to be disposed on an outer surface
of a medical instrument, such as in a coating on an outer surface
of a biopsy needle. The sealant can include any suitable known
aldehyde, including, but not limited to a glutaraldehyde glue, such
as, for example, the glutaraldehyde glue marketed under the name
BioGlue.RTM..
[0133] In still other embodiments, the instrument 500 can deliver a
sealant including any suitable hydrogel. In some embodiments, the
hydrogel is constructed of and/or includes a polyethylene glycol
polymer, which has sealant properties that are configured to be
activated upon exposure to a light source. In some embodiments, the
sealant including the hydrogel can be configured to be
bioabsorbable. In some embodiments, the sealant including the
hydrogel is configured to be delivered to the body of the patient
as a liquid. In some embodiments, the sealant can be or include the
hydrogel marketed under the name Focal Seal-L, commercially
available from Gynzyme Bioscience.
[0134] The instrument 500 includes a first shaft 502, a second
shaft 512, a reference marker 524, and a sensor 526. The first
shaft 502 defines a lumen 504 and an opening 506 in communication
with the lumen 504 of the first shaft 502. At least a portion of
the first shaft 502 is disposable within the body of the
patient.
[0135] The second shaft 512 defines a lumen 516, a chamber 514, and
an opening 518 in communication with the chamber 514 of the second
shaft 512. The chamber 514 of the second shaft 512 is configured to
receive the sealant (not shown). In use, the sealant can be
disposed within the chamber 514 prior to disposing the first shaft
502 within the body of the patient. For example, in some
embodiments, the sealant can be conveyed into the chamber 514 via
the opening 518 before the first shaft 502 and/or the second shaft
512 are disposed within the body. In other embodiments, the sealant
is disposed in the chamber 514 while the first shaft 502 and/or the
second shaft 512 are disposed within the body of the patient, e.g.,
via an injection source.
[0136] The lumen 516 of the second shaft 512 is fluidically
isolated from the chamber 514 of the second shaft 512. The lumen
516 of the second shaft 512 is configured to receive a medical
instrument. For example, the lumen 516 of the second shaft 512 can
receive at least one of a light source, a scope, a biopsy tool, a
camera, or the like. In this manner, the second shaft 512 provides
access for the medical instrument to the body of the patient. For
example, in some embodiments, a light source can be received in
and/or passed through the lumen 516 of the second shaft such that
the light source is proximate to the sealant delivered to the body
of the patient.
[0137] The second shaft 512 is configured to be received within the
lumen 504 of the first shaft 502. In some embodiments, the second
shaft 512 is tightly engaged with the first shaft 502. In other
words, the second shaft 512 is not freely movable with respect to
the first shaft 502 in the absence of a force (e.g., a force
applied by the physician to move the second shaft 512). The second
shaft 512 has a first position, as shown in FIG. 13, in which the
opening 518 of the second shaft 512 is fluidically isolated from
the opening 506 of the first shaft 502. The second shaft 512 has a
second position (not shown in FIGS. 11-13) in which the opening 518
of the second shaft 512 is in fluid communication with the opening
506 of the first shaft 502. When the second shaft 512 is in the
second position, the opening 506 of the first shaft 502 and the
opening 518 of the second shaft 512 define a flow passageway for
the sealant. The flow passageway is configured to permit movement
of the sealant from the chamber 514 of the second shaft 512 to a
location exterior to the first shaft 502.
[0138] In some embodiments, the second shaft 512 is movable with
respect to the first shaft 502 in at least one rotational
direction, as indicated by arrow A.sub.1 in FIG. 13. For example,
the second shaft 512 can be configured to rotate in at least one of
a clockwise or a counter-clockwise direction. The second shaft 512
is moved from its first position to its second position by rotating
the second shaft 512 with respect to the first shaft 502. In use,
the second shaft 512 is moved to its second position to deliver the
sealant to the body of the patient. In other embodiments, the
second shaft 512 is movable with respect to the first shaft 502 in
at least one longitudinal direction.
[0139] The reference marker 524 is disposed on at least one of the
first shaft 502 or the second shaft 512. In the embodiment
illustrated in FIG. 11, the reference marker 524 is disposed on an
outer surface of the first shaft 502. The reference marker 524 is
configured to be viewed by an imaging device (not shown) that is
exterior to the body of the patient when the reference marker 524
is disposed within the body of the patient. For example, the
reference marker 524 can be configured to be viewed by any imaging
device (or modality) described herein, such as imaging device 40.
In some embodiments, the reference marker 524 is similar in many
respects to the instrument reference marker 18, described
herein.
[0140] The sensor 526 is coupled to a distal end portion 503 of the
first shaft 502. The sensor 526 is configured to sense a pressure
within a portion of the body of the patient at which the sensor 526
is disposed. The sensor 526 can be any suitable known pressure
sensor, such as, for example a piezo-electric pressure transducer.
In some embodiments, the sensor 526 is configured to sense a first
pressure at a first portion of the body of the patient and a second
pressure at a second portion of the body of the patient. Thus, the
sensor 526 can be characterized as being configured to detect a
spatial change in pressure within the body of the patient. In some
embodiments, the sensor 526 is configured to sense a first pressure
at a first time at an area within the body of the patient at which
the sensor is disposed and a second pressure at a second time
different than the first time at the area within the body of the
patient. Thus, the sensor 526 can be characterized as being
configured to detect a temporal change in pressure within the body
of the patient. In this manner, the sensor 526 can facilitate
delivery of the sealant because the sensor 526 can provide an
indication of a desired status of a target anatomy (e.g.,
exhalation of the lungs) and/or an indication of a desired location
of the instrument with respect to the target anatomy (e.g., when
the sensor of the instrument detects the second pressure indicating
the sensor of the instrument has moved from a position inside the
lung to a position proximate to the surface of the lung).
[0141] Although the instrument 500 is illustrated and described as
including a second shaft 512 defining a lumen 516, in other
embodiments, a third shaft is disposed within at least one of the
first shaft or the second shaft. In this manner, the second shaft
need not include the lumen as described herein. The third shaft can
be movable with respect to at least one of the first shaft and the
second shaft.
[0142] A medical instrument 550 configured to deliver a sealant to
a body of a patient according to an embodiment is illustrated in
FIGS. 14-15. The instrument 550 includes a first shaft 552, a
second shaft 560, and a plunger 566. The first shaft 552 defines a
lumen 554 and an opening 556 in communication with the lumen 554 of
the first shaft 552. The first shaft 552 defines a tapered distal
tip 553. The tapered distal tip 553 is configured to pierce,
puncture and/or displace bodily tissue. In this manner, the
instrument 550 is configured to penetrate a bodily tissue (e.g.,
the skin, the lung). Although the tapered distal tip 553 is shown
as being sharp, in other embodiments, the tapered distal tip 553
can include a slightly rounded tip.
[0143] The second shaft 560 defines a chamber 562 and an opening
564 in communication with the chamber 562. The chamber 562 is
configured to receive a sealant. The sealant can be any suitable
sealant described herein. At least a portion of the second shaft
560 is received within the lumen 554 of the first shaft 552. The
second shaft 560 is movable with respect to the first shaft 552 in
at least one rotational direction, as indicated by arrow A.sub.2 in
FIG. 15, and as described above with respect to instrument 500. The
second shaft 560 is configured to be rotated with respect to the
first shaft 552 to align the opening 564 of the second shaft 560
with the opening 556 of the first shaft 552. In this manner, the
aligned openings 556, 564 form a flow passageway through which the
sealant can move from the chamber 562 to an area external to the
first shaft 552.
[0144] At least a portion of the plunger 566 is disposed within the
chamber 562 of the second shaft 560. The plunger 566 is configured
to be translationally moved with respect to the second shaft 560.
The plunger 566 can be moved in a distal direction, for example,
such that a portion of the plunger 566 contacts the sealant
received in the chamber 562. In this manner, the plunger 566 is
configured to facilitate delivery of the sealant to the body of the
patient.
[0145] Although the second shafts described above (e.g., second
shaft 512, 560) have been illustrated and described as being
movable with respect to the first shafts described above (e.g.,
first shaft 502, 552) in at least one rotational direction, in
other embodiments, as illustrated in FIG. 16, a medical device 580
according to an embodiment includes a second shaft 590 that is
movable with respect to the first shaft 582 in at least a one
translational direction, as indicated by arrow A.sub.3. For
example, in some embodiments, the second shaft 590 is configured to
be translationally moved with respect to the first shaft in at
least one of a proximal direction or a distal direction. The second
shaft 590 is moved from a first position in which an opening 594
defined by the second shaft 590 is fluidically isolated from an
opening 586 defined by the first shaft 582 to a second position in
which the opening 594 of the second shaft 590 is in fluid
communication with the opening 586 of the first shaft 582 by
translating the second shaft 590 with respect to the first shaft
582. In some embodiments, the second shaft 590 can be moved from
its first position to its second position by translationally moving
a handle portion 596 coupled to the second shaft 590 (e.g., in at
least one of the distal or the proximal directions).
[0146] The first shaft 582 is configured to define an opening
within the bodily tissue of the patient. In some embodiments, as
illustrated in FIG. 16, the first shaft 582 includes a coating 588
disposed on at least a portion of the outer surface of the first
shaft 582. The coating 588 is configured to form a seal between the
portion of the first shaft 582 and a portion of the body B of the
patient in contact with the outer surface of the portion of the
first shaft 582 when the first shaft 582 defines and/or is disposed
within the opening of the bodily tissue.
[0147] In some embodiments, the seal is formed in response to the
coating 588 being exposed to a bodily fluid. In some embodiments,
the coating 588 includes the sealant. For example, the coating 588
can include at least one of thrombin, fibrinogen, a cyanocrylate,
collage, a cross-linker, an aldehyde, or a hydrogel, or the like,
or any combination of the foregoing.
[0148] At least one of the coating 588 or the sealant has a first
physical state prior to the coating 588 being exposed to the bodily
fluid (or contacting the body B) and a second physical state
different than the first physical state after the coating is
exposed to the bodily fluid. For example, in some embodiments, the
coating 588 can include a solid material disposed on an outer
surface of a portion of the first shaft 582 (e.g., a biopsy needle)
and can include the sealant in the form of a liquid and/or gel
within a matrix of the solid coating 588. The coating 588 can be
configured to change from the first solid physical state to a
second physical state, e.g., a liquid, in response to being exposed
to the bodily fluid. As the coating 588 is liquefied, the sealant
is released from the matrix, and thus delivered to the body part B
(e.g., skin, a lung, a heart). In another example, the coating 588
and the sealant are solidified on the outer surface of the medical
instrument 580 (e.g., a catheter). As the sealant is exposed to the
bodily fluid (e.g., blood, mucous, or the like) the sealant is
changed from its first physical state, e.g., solid, to its second
physical state, e.g., liquid, and the seal is formed between the
first shaft 582 and a portion of the body B of the patient in
contact with the outer surface of the portion of the first shaft
582. Although the coating 588 is shown as being disposed about
substantially all of the first shaft 582, in other embodiments, the
coating 588 can be disposed about only a portion of the first shaft
582.
[0149] While various embodiments have been described herein, it
should be understood that they have been presented by way of
example only, and not limitation. Where methods described herein
indicate certain events occurring in certain order, the ordering of
certain events may be modified. Additionally, certain of the events
may be performed concurrently in a parallel process when possible,
as well as performed sequentially as described above. Furthermore,
although methods are described above as including certain events,
any events disclosed with respect to one method may be performed in
a different method according to the invention. Thus, the breadth
and scope should not be limited by any of the above-described
embodiments. While the invention has been particularly shown and
described with reference to specific embodiments thereof, it will
be understood that various changes in form and details may be
made.
[0150] For example, although the at least one of the coating 588 or
the sealant is described herein as changing from the first physical
state to the second physical state in response to exposure to the
bodily fluid, in other embodiments, the coating and/or the sealant
can be configured to change physical states in response to a
different agent. For example, in some embodiments, at least one of
the coating or the sealant is configured to change from the first
physical state to the second physical state upon placing the
coating and/or the sealant in contact with the body B, and/or upon
placing the coating and/or sealant in contact with a second coating
that is disposed on another medical instrument or on the body of
the patient. In some embodiments, the change in physical state is
caused by a chemical reaction between a material included in at
least one of the coating 588 and the sealant and a bodily or other
fluid (e.g., saline) or another material. In yet other embodiments,
the change in physical state of the coating 588 can be caused by a
thermal reaction (e.g., heating of the outer surface of the first
shaft 582). For example, in some embodiments, the first shaft 582
can include a heater configured to allow a user to selectively
increase the temperature of the outer surface of the first shaft
582 to trigger the change in the physical state of the coating
588.
[0151] Although the delivery instruments (e.g., instruments 500,
550, 580) have been illustrated and described herein as including
at least two co-axial shafts, in other embodiments, a delivery
instrument can include non-coaxial shafts and/or any suitable
number of shafts. For example, in some embodiments, a delivery
instrument includes a first shaft defining a lumen and a second
shaft and third shaft, each disposable within the lumen of the
first shaft. The second shaft can define a chamber that contains a
sealant, and the third shaft can be configured to receive a medical
instrument (e.g., a scope). In another example, a delivery
instrument can include a first shaft having a longitudinal axis and
a second shaft configured to be at least partially disposed within
a lumen of the first shaft. The second shaft can have a
longitudinal axis that is non-coaxial with and/or nonparallel to
the longitudinal axis of the first shaft. For example, the
longitudinal axis of the second shaft can be parallel to the
longitudinal axis of the first shaft. In another example, the
longitudinal axis of the second shaft can be transverse to the
longitudinal axis of the first shaft. In another example, a
delivery instrument includes a first shaft and a second shaft
disposed adjacent the first shaft. Each of the first shaft and the
second shaft defines a lumen. The lumen of the first shaft and the
lumen of the second shaft are each configured to be in fluid
communication with a lumen of a third shaft. For example, a first
sealant material can be disposed in the lumen of the first shaft
and a second sealant material can be disposed in the lumen of the
second shaft. At the time of delivery of the sealant to the target
anatomy, at least a portion of the first sealant material is moved
to the lumen of the third shaft and at least a portion of the
second sealant material is moved to the lumen of the third shaft.
In this manner, the first sealant material and the second sealant
material can be combined prior to delivery of the sealant to the
target anatomy.
[0152] Although the second shaft 512 of instrument 500 is
illustrated and described as defining the lumen 516, in other
embodiments, the second shaft can define any suitable number of
lumens, e.g., two, three, or more. In other embodiments, the second
shaft 512 of the instrument 500 can be devoid of a lumen.
[0153] Although the lumen 516 of the second shaft 512 of instrument
500 is illustrated and described herein as being fluidically
isolated from the chamber 514 of the second shaft 512, in some
embodiments, the lumen of the second shaft is configured to be
placed in fluid communication with the chamber of the second
shaft.
[0154] Although the instrument 500 is illustrated and described
herein as including the reference marker 524 on at least one of its
first shaft 502 or its second shaft 512, in other embodiments, the
instrument includes any suitable number of reference markers on its
first shaft and/or its second shaft, e.g., two, three, or more
reference markers. In other embodiments, the instrument 500 need
not include any reference markers.
[0155] A medical instrument 600 configured to deliver a seal member
620 to a body of a patient according to an embodiment is
illustrated in FIGS. 17-18. The instrument 600 includes an elongate
shaft 602, a delivery mechanism 612, a reference marker 616, a
sensor 618, and a seal member 620. The elongate shaft 602 has a
proximal end portion 603 and a distal end portion 605 and defines a
lumen 606. At least a portion of the elongate shaft is disposable
within the body of the patient.
[0156] The delivery mechanism 612 is movable with respect to the
elongate shaft 602 and includes a protrusion 614. Additionally, the
protrusion 614 is movable with respect to the remainder of the
delivery mechanism 612. In some embodiments, the delivery mechanism
612 is movably coupled to the elongate shaft 602. In some
embodiments, the delivery mechanism 612 is a stylet, an expandable
wire mechanism, or the like. The delivery mechanism 612 is movable
between a first configuration (illustrated in FIG. 17) and a second
configuration (illustrated in FIG. 18). The protrusion 614 is
extended from the delivery mechanism 612 at a first angle when the
delivery mechanism 612 is in its first configuration. For example,
in some embodiments, the first angle can be an angle between zero
and 89 degrees (i.e., an acute angle) with respect to the remainder
of the delivery mechanism 612. In other embodiments, for example,
the first angle can be an angle 90 degrees or greater with respect
to the delivery mechanism. The protrusion 614 is extended from the
delivery mechanism 612 at a second angle greater than the first
angle when the delivery mechanism 612 is in its second
configuration. In some embodiments, the protrusion 614 of the
delivery mechanism 612 is biased towards being extended from the
delivery mechanism 612 at the second angle. Similarly stated, in
some embodiments, the protrusion 614 is biased in the second
configuration.
[0157] The delivery mechanism 612 is configured to move the seal
member 620 between a collapsed configuration (illustrated in FIG.
17) and an expanded configuration (illustrated in FIG. 18) when the
delivery mechanism 612 is moved from its first configuration to its
second configuration. In some embodiments, the movement of the
protrusion 614 from its first position to its second position, and
thus movement of the seal member 620 from its collapsed
configuration to its expanded configuration, is similar to the
operation of an umbrella.
[0158] The seal member is configured to seal an opening within the
body of the patient when the seal member 620 is in its expanded
configuration. At least a portion of the seal member 620 is
disposed within the lumen 606 of the elongate shaft 602 when the
seal member is in its collapsed configuration, as illustrated in
FIG. 17. In other words, at least a portion of the seal member 620
is deformable for delivery of the seal member 620 to the bodily
tissue.
[0159] As illustrated in FIGS. 19-20, the seal member 620 includes
a substrate 622 and a sealant 630 disposed on a portion of the
substrate 622. The substrate 622 couplable to a bodily tissue of
the patient. In some embodiments, for example, the substrate 622 is
couplable to a dynamic bodily tissue (e.g., the lung, the heart)
within a bodily cavity of a patient. In another example, the
substrate 622 is configured to be disposed on an interior surface
of an organ of the patient. For example, the substrate 622 can be
disposed on an interior surface of the lung of the patient.
[0160] The substrate 622 has a first surface 624 and a second
surface 626 different than the first surface 624. An adhesive 628
is disposed on the second surface 626 of the substrate 622. The
adhesive 628 is configured to couple the substrate adjacent to the
bodily tissue (e.g., the dynamic bodily tissue). At least a portion
of the substrate 622 is configured to be penetrated by a medical
instrument M (see e.g., FIG. 20). Said another way, the substrate
622 is configured to maintain its structural integrity and/or
retain its functional qualities (e.g., being coupled to the bodily
tissue B) when the medical instrument M is inserted through the
substrate 622.
[0161] As illustrated in FIG. 20, the sealant 630 is disposed in a
cavity 623 defined by the substrate 622 between the first surface
624 of the substrate 622 and the second surface 626 of the
substrate. In some embodiments, the sealant 630 is a liquid or a
gel sealant disposed in the cavity 623 of the substrate 622. The
sealant 630 can be any suitable known sealant of the types shown
and described herein.
[0162] The sealant 630 is configured to be penetrated by the
medical instrument M when the medical instrument M is inserted
through the substrate 622. The sealant 630 is configured to
substantially prevent passage of a material through an opening in
the substrate 622 formed by the medical instrument M. In other
words, the sealant 630 forms a seal about the portion of the
medical instrument M inserted through the sealant 630, e.g.,
between the medical instrument M and the substrate 622. In this
manner, the seal member 620 is configured to substantially prevent
the passage of an environmental contaminant through the opening
defined by the medical instrument and into the body of the patient.
Also in this manner, the seal member 620 is configured to
substantially prevent the passage of a bodily fluid from an area
inside the body of the patient through the opening defined by the
medical instrument.
[0163] Referring again to FIGS. 17-18, the delivery mechanism 612
includes the reference marker 616. The reference marker 616 is
configured to be viewed by an imaging device (e.g., imaging device
40, described herein) that is exterior to the body of the patient
when the reference marker 616 is disposed within the body of the
patient. The reference marker 616 can be, for example, any suitable
reference marker described herein.
[0164] The sensor 618 is coupled to the elongate shaft 602. At
least a portion of the sensor 618 is disposed on the distal end
portion 605 of the elongate shaft 602. The sensor 618 is configured
to detect a pressure at a location within the body of the patient
proximate to the distal end portion 605 of the elongate shaft 602
(and/or a portion of the delivery mechanism 612). The sensor 618
can be any suitable sensor, for example, a sensor according to an
embodiment (e.g., sensor 524) described herein.
[0165] In some embodiments, the medical instrument M (or another
medical instrument) can be received in the elongate shaft 602 of
the instrument 600. For example, in some embodiments, the medical
instrument M can be received in the lumen 606 of the elongate shaft
602 alongside the delivery mechanism 612. In another example, the
medical instrument M can be received in the lumen 606 of the
elongate shaft 602 prior to placement of the delivery mechanism 612
within the lumen 606 of the elongate shaft 602 and/or after removal
of the delivery mechanism 612 within the lumen 606 of the elongate
shaft 602. The medical instrument M can be any suitable medical
instrument described herein, including, but not limited to, a light
source, a scope, a biopsy tool, a camera, or the like. For example,
the instrument 600 can be used in conjunction with a scope to
facilitate placement and/or delivery of the sealant 630 to a target
anatomy.
[0166] Although the sealant 630 is illustrated and described as
being disposed within the cavity 623 of the substrate 622, in other
embodiments, the sealant can be disposed on a different portion of
the substrate. For example, in some embodiments, the sealant is
disposed on at least one of the first surface or the second surface
of the substrate.
[0167] Although the adhesive 628 is illustrated and described as
being disposed on the second surface 626 of the substrate 622, in
other embodiments, the adhesive can be disposed on a different
portion of the substrate. For example, in some embodiments, the
adhesive is disposed on the first surface of the substrate. In
still other embodiments, the seal member includes no adhesive.
[0168] Although the instrument 600 is illustrated and described as
including a single elongate shaft 602, in some embodiments, an
instrument for delivering a seal member includes at least two
elongate shafts. For example, in some embodiments, the instrument
includes a first elongate shaft configured to pierce and/or
penetrate the bodily tissue. In some embodiments, the first
elongate shaft is configured to biopsy the bodily tissue. The
second elongate shaft is disposable within a lumen of the first
elongate shaft. The first elongate shaft can be at least partially
withdrawn from being disposed about the second elongate shaft. The
second elongate shaft can be configured to deliver the seal member,
e.g., as described herein with respect to instrument 600. In use,
the physician can at least partially withdraw the first elongate
shaft, e.g., until a distal end portion of the first elongate shaft
contacts a surface of the bodily tissue. The seal member is moved
to its expanded configuration and delivered to the bodily tissue
with the second elongate shaft.
[0169] Although the protrusion 614 of the delivery mechanism 612 is
illustrated and described herein as being movable with respect to
the delivery mechanism 612 between a first angle and a second
angle, in other embodiments, a delivery mechanism can include a
protrusion differently configured for moving the seal member from
the collapsed configuration to the expanded configuration. For
example, in some embodiments, the delivery mechanism includes a
spring protrusion. The spring protrusion is compressed by a shaft
of the instrument when the protrusion is disposed within the shaft
of the instrument. The spring protrusion is configured to move to a
non-compressed or expanded position when the spring protrusion is
no longer compressed by the shaft of the instrument. In this
manner, the spring protrusion is configured to move the seal member
to its expanded configuration when the spring protrusion is moved
to its non-compressed position.
[0170] Although the seal member 620 has been illustrated and
described herein as being delivered to a tissue within the body of
the patient and using the instrument 600, in other embodiments, the
seal member can be delivered to a surface of the body of the
patient (e.g., the skin) with any suitable instrument or without
the assistance of an instrument. For example, in some embodiments,
the seal member 620 can be disposed over an area of the patient's
skin through which the medical instrument M will be inserted. The
second surface 626 of the substrate 622 is placed against the skin
and can be configured to seal against the skin. For example, the
adhesive 678 can be configured to adhere to the skin. As the
medical instrument M is inserted through the seal member and into
the body of the patient, a seal is formed between the sealant 630
and the medical instrument. Thus, the seal member substantially
prevents air or other potentially harmful elements from entering
the patient's body at the entry site. In other embodiments, the
physician can make an incision through the seal member 620 and the
skin. In still other embodiments, the seal member 620 can be
pre-cut with an incision slot (not shown) so that the physician can
make an incision in the skin through the pre-cut slot.
[0171] Methods according to embodiments include delivering a
sealant to a bodily opening utilizing a medical instrument in
conjunction with a system and/or a method for IGI described herein.
For example, FIG. 21 is a flow chart of a method 450 according to
an embodiment. The method 450 includes viewing a representation of
an instrument within a body of a patient, 452. The instrument can
be any suitable medical instrument described herein (e.g.,
instruments 16, 500, 550, 600). The representation is superimposed
on an image of a set of images associated with a cyclical movement
of a body part (e.g., the targeted anatomy), for example as
described above with respect to method 250 and/or method 350. The
image is associated with a MDV. The MDV, as described in detail
above, is the dataset vector associated with a current vector that
is calculated based on a current position of a first reference
marker (e.g., internal reference marker 24) and a current position
of a second reference marker (e.g., external reference marker 22),
as described in more detail above. The second reference marker is
depicted in at least one image of the set of images. In some
embodiments, the viewing the representation of the instrument
includes detecting a representation of a third reference marker.
The third reference marker can be disposed on the instrument,
similar to the instrument reference marker 18, described above.
[0172] Optionally, the method 450 includes generating the set of
images. The set of images can be generated using any suitable
imaging modality described herein. For example, the set of images
can be generated using at least one of a 2-D, 3-D, or a 4-D imaging
modality (or imaging device). In some embodiments, for example, the
set of images is generated using at least one of fluoroscopy,
computed tomography, magnetic resonance imaging, positron emission
tomography, ultrasound, or optical coherence tomography.
[0173] The method 450 includes adjusting a position of the
instrument based on the viewing such that a portion of the
instrument is at a location within the body of the patient, 454.
For example, the adjusting can include moving the medical
instrument 16 from a first position to a second position different
than the first position. In some embodiments, the position of the
medical instrument 16 is adjusted such that the medical instrument
16 is at a location within the patient's 10 body that is proximate
to an opening formed in or by the target anatomy. In some
embodiments, for example, the opening can be a puncture or an
incision site formed in the target anatomy. The puncture or
incision site, for example, may have been formed by the physician
14 using the medical instrument 16 while performing a medical
procedure (e.g., a biopsy) in or proximate to the target anatomy.
In another example, the opening can be a natural bodily opening
formed by the body of the patient, such as due to genetics and/or
disease.
[0174] The method 450 includes delivering a sealant via the
instrument to the location within the body of the patient, 456. The
sealant is configured to seal an opening in the body part. For
example, the sealant can be configured to seal a puncture or
incision site or a natural body opening, described above. In some
embodiments, the sealant is configured to form a seal between a
portion of the instrument and the body part defining the opening,
as described above with respect to instrument 580. As described
above, the sealant can include any suitable material, including,
but not limited to thrombin, fibrinogen, a cyanocrylate, collagen,
a cross-linker, an aldehyde, or a hydrogel.
[0175] In some embodiments, the method 450 optionally includes
detecting a first pressure within a portion of the body of the
patient proximate to the instrument at a first time and detecting a
second pressure within a portion of the body of the patient
proximate to the instrument at a second time later than the first
time. The second pressure is at least a threshold value. The
delivering the sealant is performed when the second pressure is
detected. For example, referring to the use of instrument 500 in a
lung biopsy procedure, at least a portion of the instrument 500 can
be positioned within a lung of the patient. The first pressure can
be a pressure associated with the lung being filled with an amount
fluid (e.g., air, a bodily liquid). For example, the first pressure
can be a pressure within the lung associated with exhalation by the
patient. The second pressure can be a pressure associated with the
lung being filled with a different amount of fluid. For example,
the second pressure can be a pressure within the lung associated
with inhalation by the patient. Each of the first pressure and the
second pressure is detected by the sensor 526. In this manner, the
physician can deliver the sealant upon detecting the second
pressure, for example, when the patient's lung is inflated and/or
filled with the fluid to a specified amount.
[0176] In some embodiments, the method 450 optionally includes
detecting a first pressure within a portion of the body of the
patient proximate to the instrument at its first position and
detecting a second pressure within a portion of the body of the
patient proximate to the instrument at its second position
different than the first position. The second pressure is at least
a threshold value, and the delivering is performed when the second
pressure is detected. For example, in a lung biopsy procedure, the
first pressure can detected within a lung of the patient when the
instrument is disposed at a first position proximate to and/or
within the lung. The second pressure can be, for example, a
pressure at an area at the surface of the lung and/or exterior to
the lung proximate to the instrument at its second position. In
this manner, the spatial change in pressure from the first location
within the lung to the second location at the surface of and/or
exterior to the lung facilitates detection by the physician of
where the instrument is positioned with respect to the lung. In
other words, the physician can detect the first pressure
representing a pressure associated with the first location inside
of the lung. The physician can then move the instrument until the
physician detects the second pressure representing a pressure
associated with the second location outside of the lung. In this
manner, the physician can detect when the instrument is moved
outside of the lung (e.g., and is proximate to the lung surface) by
detecting the change in pressure, and thus can deliver the sealant
when the instrument is outside of the lung. Also in this manner,
because the physician can detect the change in pressure as it
occurs, the sealant can be delivered to the puncture site at which
the instrument entered the lung.
[0177] In some embodiments, the delivering includes releasing a
seal member from a delivery instrument and disposing the seal
member on or proximate to a body part having cyclical movement. For
example, in some embodiments, seal member 620 is moved to its
expanded configuration and is then released from instrument 600.
The seal member 620 can, for example, become disengaged from the
delivery mechanism 612 after the adhesive 626 of the seal member
620 contacts the bodily tissue B. In another example, the seal
member 620 is released from the delivery mechanism 612 when the
delivery mechanism is moved to its second configuration. The
protrusion 614, for example, can be configured to disengage the
seal member 620 from the delivery mechanism 612.
[0178] In some embodiments, the delivering includes disposing at
least a portion of the sealant on an interior surface of the body
part. For example, in some embodiments, the sealant can be disposed
on a surface of a substrate of a seal member (e.g., a patch). The
seal member, including the sealant, can be delivered to (or
disposed on) an interior surface of the lung, for example, using
instrument 600. In use, the seal member is moved from its collapsed
configuration (e.g., its first configuration) to its expanded
configuration (e.g., its second configuration) while the distal end
portion 605 of the instrument 600 is disposed within an interior
cavity of the lung. The instrument 600 is then withdrawn from the
lung of the patient. As the instrument 600 is withdrawn, the
expanded seal member engages the interior surface of the lung.
Because the seal member is expanded, it is not withdrawn with the
instrument 600, and thus remains in the lung.
[0179] In some embodiments, the delivering includes exposing a
coating disposed on an outer surface of a portion of the instrument
to a bodily fluid. For example, the exposing the coating 588 can
cause a physical stage change in the coating as described above
with respect to instrument 580. In some embodiments, the coating
588 is placed in contact with the body part having cyclical
movement (e.g., the target dynamic anatomy).
[0180] In some embodiments, the delivering includes moving a first
shaft of the instrument with respect to a second shaft of the
instrument to place an opening defined by the first shaft in fluid
communication with an opening defined by the second shaft. For
example, as described above with respect to instrument 500, the
first shaft 502 defines the opening 506 and the second shaft
defines the opening 518. The second shaft 512 can be rotated to
align the openings 506, 518. In this manner, the opening 506 of the
first shaft 502 is placed in fluid communication with the chamber
514 of the second shaft 512, and the sealant can be delivered.
[0181] In some embodiments, the delivering includes delivering a
seal member including the sealant via a working channel of an
instrument, for example, via the lumen 606 of the instrument 600.
In some embodiments, the delivering includes delivering a seal
member that is wrapped about a portion of the delivery instrument.
For example, in some embodiments, at least a portion of the seal
member is wrapped about a distal end portion of the delivery
instrument. To deliver the seal member, and thus a sealant disposed
on the seal member, the portion of the delivery instrument
including the seal member can be twisted and/or twirled to release
and/or expand the seal member. In some embodiments, the physician
maintains the position of the delivery instrument, and thus the
seal member, to allow an adhesive disposed on the seal member to
adhere to the bodily tissue. The delivery instrument can then be
withdrawn from the body of the patient, leaving the seal member
within the body of the patient.
[0182] In some embodiments, the delivering includes inserting a
seal member including the sealant and that is disposed about an
outer surface of an elongate shaft into, through, beyond, or
proximate to the target anatomy. The elongate shaft is withdrawn
from the anatomy and, because the seal member is loosely coupled to
the outer surface of the elongate shaft, the seal member is
released from the elongate shaft. In some embodiments, a portion of
the seal member is withdrawn with the elongate shaft such that the
seal member is disposed within and/or occludes the puncture
opening.
[0183] In some embodiments, the delivering includes delivering a
seal member including the sealant with an instrument having a
plurality of shafts. The seal member is coupled to the instrument
such that, upon a rotation (or twisting) and/or translation (or
pushing or pulling) of one shaft with respect to another shaft, a
flap portion of the seal member is expanded. In use, the instrument
is used to position the seal member proximate to the desired
location within the body of the patient. The physician then moves
the one shaft in at least one of a rotational or a translational
movement with respect to the second shaft until the flap portion of
the seal member is expanded (or exposed). The physician then
engages the bodily tissue with the expanded seal member to adhere
at least a portion of the seal member to the bodily tissue. As the
instrument is withdrawn from the body of the patient, the seal
member remains adhered to the bodily tissue. When the instrument is
fully withdrawn from the body of the patient, at least one flap one
the flap portion of the seal member overlap to seal the puncture
opening.
[0184] In some embodiments, the method 450 also includes applying
an activation agent to or proximate to the sealant. For example, in
some embodiments, the activation agent is an energy source. The
energy source can be, for example, a light source, a heat source,
or the like. Referring to instrument 500, the energy source can be
disposed within the lumen 516 of the second shaft 512 such that
energy from the energy source can reach (or access) the sealant
within the body of the patient. In some embodiments, the activation
agent is a chemical, a solution, a polymer, or the like configured
to initiate a phase change in the sealant, and thus activate the
sealant.
[0185] Although various embodiments have been described as having
particular features and/or combinations of components, other
embodiments are possible having a combination of any features
and/or components from any embodiment, as discussed above.
* * * * *