U.S. patent application number 11/734048 was filed with the patent office on 2007-09-06 for apparatus and method for performing a tissue resection procedure.
Invention is credited to Roy Sullivan.
Application Number | 20070208250 11/734048 |
Document ID | / |
Family ID | 38090243 |
Filed Date | 2007-09-06 |
United States Patent
Application |
20070208250 |
Kind Code |
A1 |
Sullivan; Roy |
September 6, 2007 |
Apparatus and Method for Performing a Tissue Resection
Procedure
Abstract
An apparatus and a method for performing a medical procedure is
disclosed. The apparatus includes a positioning system and a
resection device disposed within the positioning system. The
positioning system includes an imaging device, a video processor
coupled to the imaging device, a computer coupled to the video
processor, and a video display coupled to the computer. The method
includes the steps of creating an image of a lesion within a
patient's body on an imaging device. Data representative of the
lesion image is processed by a video processor. Tissue margins
around the lesion are defined by a processor based on the processed
data representative of the lesion image and a resection device is
operated during a resection procedure within the patient's body
based upon the defined tissue margins.
Inventors: |
Sullivan; Roy; (Millville,
MA) |
Correspondence
Address: |
FAY KAPLUN & MARCIN, LLP
15O BROADWAY, SUITE 702
NEW YORK
NY
10038
US
|
Family ID: |
38090243 |
Appl. No.: |
11/734048 |
Filed: |
April 11, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09603886 |
Jun 26, 2000 |
7228165 |
|
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11734048 |
Apr 11, 2007 |
|
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Current U.S.
Class: |
600/410 ;
600/300; 600/431; 600/436; 600/564; 700/90 |
Current CPC
Class: |
A61B 90/30 20160201;
A61B 10/04 20130101; A61B 17/072 20130101; A61B 2090/373 20160201;
A61B 2090/376 20160201; A61B 1/005 20130101; A61B 90/36 20160201;
A61B 17/07207 20130101; A61B 90/39 20160201; A61B 2017/00119
20130101; A61B 17/320783 20130101; A61B 5/064 20130101 |
Class at
Publication: |
600/410 ;
600/300; 600/431; 600/436; 600/564; 700/090 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Claims
1-17. (canceled)
18. A method for performing a medical procedure, comprising the
steps of: creating an image of a lesion within a patient's body on
an imaging device; processing data representative of the lesion
image by a video processor from said imaging device; defining
tissue margins around the lesion by a processor based on said
processed data representative of the lesion image; and operating a
resection device during a resection procedure within the patient's
body based upon said defined tissue margins.
19. The method of claim 18 wherein said step of creating an image
of a lesion within the patient's body on an imaging sensor includes
the steps of: applying a radiopaque die to the lesion; absorbing
the radiopaque die by the lesion; generating x-rays with a
fluoroscope; and radiating the lesion with the x-rays.
20. The method of claim 19 wherein said step of applying a
radiopaque die to the lesion includes the step of intravenously
administering the radiopaque die to the lesion;
21. The method of claim 19 wherein said step of applying a
radiopaque die to the lesion includes the step of topically
administering the radiopaque die to the lesion.
22. The method of claim 18 further comprising the step of
displaying said tissue margins on a video display.
23. The method of claim 18 wherein said step of operating the
resection device during the resection procedure within the
patient's body based upon said defined tissue margins includes the
step of disabling said resection device if said resection device is
positioned outside of said tissue margins.
24. The method of claim 18 wherein said step of operating the
resection device during the resection procedure within the
patient's body based upon said defined tissue margins includes the
step of generating an alarm signal if said resection device is
positioned outside of said tissue margins.
25. The method of claim 24 wherein said step of generating an alarm
signal if said resection device is positioned outside of said
tissue margins includes the step of sounding an audible alarm.
26. The method of claim 24 further comprising the step of disabling
said tissue margins on a video display and wherein said step of
generating an alarm signal if said resection device is positioned
outside of said tissue margins includes the step of displaying a
visual alarm on said visual display.
27. The method of claim 19 further comprising the step of
controlling said fluoroscope based on said processed data
representative of the lesion image.
28. The method of claim 27 wherein said step of controlling said
fluoroscope includes the step of altering an x-ray dosage applied
by said fluoroscope to improve an image quality of the lesion
image.
29. The method of claim 27 wherein said step of controlling said
fluoroscope includes the step of changing a physical position of
said fluoroscope to improve an image quality of the lesion
image.
30. The method of claim 18 wherein said step of creating an image
of a lesion within the patient's body on an imaging device is
performed by a magnetic resonance imager.
31. The method of claim 18 wherein said step of defining tissue
margins around the lesions includes the step of utilizing an
absolute measure of tissue.
32. The method of claim 18 wherein said step of defining tissue
margins around the lesions includes the step of utilizing a
percentage of a physical dimension of the lesion.
33. A system for imaging a tissue to be resectioned that has been
marked by a marker, comprising: an imager which remains outside a
body containing the tissue, the imager generating image data of a
selected region within the body including the tissue marked for
resection; an image processing unit analyzing the image data to
define a region of tissue that includes the tissue to be
resectioned and to locate the marker; and a control unit capable of
controlling a resection head to resect the region of tissue based
on the defined region of tissue and the location of the marker.
34. The system according to claim 33, wherein the imager includes a
fluoroscope and an x-ray imaging sensor.
35. The system according to claim 33, wherein the marker is
radiopaque.
36. The system according to claim 33, wherein the defined region of
tissue and the location of the marker are displayed on a video
display coupled with the control unit.
37. The system according to claim 33, wherein the control unit is
capable of disabling the resection head if the marker indicates
that the resection head is oriented outside the defined region of
tissue.
38. The system according to claim 33, further comprising an alarm
device, wherein the control unit transmits an alarm signal to the
alarm device when the marker indicates that the resection head is
oriented outside the defined region of tissue.
39. The system according to claim 38, wherein the alarm device
generates a visual alarm on the video display.
40. The system according to claim 33, wherein the imager is a
magnetic resonance imager.
41. The system according to claim 33, wherein the control unit
determines the defined region of tissue by an absolute measure of
tissue.
42. The system according to claim 33, wherein the control unit
determines the defined region of tissue by a percentage of a
physical dimension of a lesion.
43. A method for imaging a tissue to be resectioned that has been
marked by a marker, comprising: generating image data of a selected
region within the body including the tissue marked for resection;
analyzing the image data to define a region of tissue that includes
the tissue to be resectioned and to locate the marker; and
controlling a resection head to resect the region of tissue based
on the defined region of tissue and the location of the marker.
44. The method according to claim 43, further comprising displaying
the defined region of tissue and the location of the marker.
45. The method according to claim 43, further comprising disabling
the resection head if the marker indicates that the resection head
is oriented outside the defined region of tissue.
46. The method according to claim 43, further comprising
transmitting an alarm signal when the marker indicates that the
resection head is oriented outside the defined region of
tissue.
47. The method according to claim 43, wherein the defined region of
tissue is defined by an absolute measure of tissue.
48. The method according to claim 43, wherein the defined region of
tissue is defined by a percentage of a physical dimension of a
lesion.
49. A system for imaging a tissue to be resectioned that has been
marked by a marker,comprising: means for generating image data of a
selected region within the body including the tissue marked for
resection; means for analyzing the image data to define a region of
tissue that includes the tissue to be resectioned and to locate the
marker; and means for controlling a resection head to resect the
region of tissue based on the defined region of tissue and the
location of the marker.
50. A computer readable medium containing a set of instructions to
be executed by a processor to perform a method for imaging a tissue
to be resectioned that has been marked by a marker, the method
comprising: generating image data of a selected region within the
body including the tissue marked for resection; analyzing the image
data to define a region of tissue that includes the tissue to be
resectioned and to locate the marker; and controlling a resection
head to resect the region of tissue based on the defined region of
tissue and the location of the marker.
Description
PRIORITY CLAIM
[0001] This application is a Divisional application of U.S. patent
application Ser. No. 09/603,886 filed on Jun. 26, 2000 entitled
"Apparatus and Method for Performing a Tissue Resectioning
Procedure". The entire disclosure of this prior application is
considered as being part of the disclosure of the accompanying
application and hereby expressly incorporated by reference
herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to an apparatus and
method for performing a medical procedure. More specifically, the
invention provides for identifying target tissue margins and for
guiding a tissue resection device to the target tissue in a tissue
resection procedure.
[0004] 2. Description of the Related Art
[0005] An endoluminal procedure is a medical procedure that takes
place in one of the many tubes, or lumens, within the human body.
The endoluminal procedures may take place in vascular,
gastrointestinal, or air exchange lumens, and may involve disease
diagnosis and/or treatment. Millions of endoluminal procedures are
performed each year in hospitals around the world.
[0006] A procedure that is often carried out endoluminally is the
removal of "suspect" or diseased tissue. The purpose of such tissue
removal, or resection, may be to provide tissue samples for
histological analysis or removal of diseased tissue as a treatment
means. Today, endoluminal resection of tissue is often done using
only the subjective judgment of the clinician to determine where
tissue should be removed. As disease tissue margins are sometimes
difficult to determine visually, tissue resection guided solely by
visual cues can be inaccurate and even dangerous. The danger arises
when resectioning cancerous tissues that are prone to metastasize.
In this case, a tissue resection that occurs without sufficient
buffer of healthy tissue risks leaving behind cancerous tissue
requiring repeated resectioning procedures, or worse, causing the
cancerous lesion to "seed", or metastasize, to other parts of the
body.
[0007] FIGS. 1 and 2 illustrate a prior art endoluminal device 100
that could be used in the harvesting of diseased tissue from within
a body lumen. The device is comprised of a flexible catheter body
110 with a proximal end 112 and distal end 114. At the proximal end
112 there is a suction adjust knob 120, a coupler 130, a vacuum
hose 140, head-actuating handle 150, and an electrical interconnect
160. The vacuum hose 140 makes connection from a vacuum pump 142,
through the coupler 130, to a central lumen 170 within the catheter
body 110 to draw a suction on tissue-harvesting chamber 190. The
electrical interconnect 160 is comprised of electrical leads 161
that pass from the external electronics 162, through the coupler
130 at the proximal end 112 of the catheter body 110 to a cavity
116 outside the central lumen 170 but within the catheter body 110.
Some of the electrical leads 161 supply electrical energy to a
light source 163 and a vision chip 164 situated at the distal end
114 of the catheter 110, while another group of the electrical
leads 161 bring electrical signals from the vision chip 164 to a
video processor and a display device 165. The head-actuating handle
connects to a cable (not shown) that travels the length of the
catheter body 110 within the central lumen 170 to control the
operation of the endoluminal device's head assembly 180.
[0008] FIG. 2 is a detailed view of the distal end 114 of the
device 100 of FIG. 1. At the distal end 114 of the catheter body
110 there is a head assembly 180, a tissue-harvesting chamber 190,
a cutting device 192, and the light source 163 and the vision chip
164. The tissue-harvesting chamber 190 is connected to the central
lumen 170 of the catheter body 110. The central lumen 170 is
connected to the external vacuum pump 142. The head assembly 180 is
movable with respect to the catheter body 110 and, thus, can be
extended or retracted using the cable that is attached to the
head-actuating handle 150 at the proximal end 112 of the device 100
and to the head assembly 180 at the distal end 114 of the device
100. The cutting device 192 is a sharpened blade that severs the
tissue 200 as the retracting head assembly 180 presses the tissue
200 against the cutting device 192 to remove the suspect tissue
area 210. Distal end 114 also includes staples 194 and anvil
surface 196 which are utilized to staple the site. The vision chip
164 is connected to the external video processor and display device
165 via the electrical leads 161 within the catheter body 110, but
outside of the central lumen 170.
[0009] FIG. 2 also illustrates the distal end 114 of the prior art
tissue-resectioning device 100 as it would appear having been
inserted into a body lumen. Extended into the body lumen, the
Endoscopist would guide the distal tip 114 of the device into close
proximity with the tissue 200 to be resected. By adjusting the
suction at the tip 114 with the suction adjust knob 120, the
clinician can then increase the suction at the tip 114 until the
tissue 200 is drawn into the tissue harvesting chamber 190 through
a distal opening 114A and into the tissue harvesting chamber 190.
Once the tissue is in position, the clinician can then retract the
head assembly 180 to perform the resection. The suspect tissue 210
is removed and the site is stapled with the staples contained in
the head assembly 180. With the tissue sample 210 enclosed within
the tissue-harvesting chamber 190, the device 100 can be removed
from the body lumen and the tissue sample 210 removed.
[0010] Today, a tissue-resectioning procedure such as described
above would be guided by the clinician based upon whatever limited
visual information could be obtained through the vision chip 164 at
the distal end 114 of the catheter 110. Whereas histological
staining may be used to assist in tissue margin identification,
guiding the resection device 100 in the procedure in this manner is
still a very subjective process and prone to error. There is a high
probability that either too much or too little tissue will be
resected. Both of the outcomes are undesirable, and even
dangerous.
[0011] Therefore, it would be desirable to provide an improved
system and method for assisting a practitioner in accurately
identifying target tissue margins and guiding the practitioner to
the target tissue.
SUMMARY OF THE INVENTION
[0012] An apparatus and a method for performing a medical procedure
is provided. In an embodiment for an apparatus of the present
invention, the apparatus includes a positioning system and a
resection device disposed within the positioning system. The
positioning system includes an imaging device, a video processor
coupled to the imaging device, a computer coupled to the video
processor, and a video display coupled to the computer. In an
embodiment for a method of practicing the present invention, the
method includes the steps of creating an image of a lesion within a
patient's body on an imaging device. Data representative of the
lesion image is processed by a video processor. Tissue margins
around the lesion are defined by a processor based on the processed
data representative of the lesion image and a resection device is
operated during a resection procedure within the patient's body
based upon the defined tissue margins.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The various features of the invention will best be
appreciated by simultaneous reference to the description which
follows and the accompanying drawings, in which:
[0014] FIG. 1 illustrates a known endoluminal device;
[0015] FIG. 2 is a detailed view of the distal end of the device of
FIG. 1; and
[0016] FIG. 3 is an embodiment of a system for performing a medical
procedure in accordance with the principles of the present
invention.
DETAILED DESCRIPTION
[0017] FIG. 3 illustrates an embodiment of a system for performing
a medical procedure in accordance with the principles of the
present invention. As can be seen in FIG. 3, the system 30 includes
a positioning system 300 and a resection device 100. In the
illustrated embodiment, the positioning system 300 includes a
fluoroscope 310, an x-ray imaging sensor 320, video processing
electronics 330, a computer 340, a video display 350, and an alarm
360. As can be further seen in FIG. 3, the system 30 further
includes a resection device 100 that is positionable within the
positioning system 300. Resection device 100, as is well-known in
the art, can be utilized to remove an internal lesion 420 from a
tubular organ 410 within a body wall 400 of a patient and resect
the tissue of the tubular body organ 410 from which lesion 420 is
removed. As will be further explained later in this specification,
fluoroscope 310 generates x-rays that are detected by the x-ray
imaging sensor 320. The x-rays generated by fluoroscope 310 pass
through the patient and lesion 420 to be collected on x-ray imaging
sensor 320. A radiopaque die, having selectively been absorbed by
lesion 420, creates an image of the boundaries of lesion 420 on
x-ray imaging sensor 320. Image information from x-ray imaging
sensor 320 related to lesion 420 is communicated to video
processing electronics 330 where the video processing electronics
processes the image information from sensor 320 and provides
digitized image data to computer 340. Computer 340 utilizes the
digitized image data to identify a tissue margin 420A around lesion
420. The tissue margin 420A is provided to video display 350 where
the tissue margin can be displayed relative to lesion 420.
[0018] In addition to computer 340 receiving position image data
for lesion 420 from x-ray imaging sensor 320, computer 340 is also
able to receive position image data for resection device 100. Thus,
computer 340 is able to provide relative positioning data for
resection device 100, lesion 420, and the defined tissue margin
420A.
[0019] Through use of the present system 30, if, during the
resection procedure, the resection device, through operation by the
surgeon, is in danger of severing tissue outside of tissue margin
420A or is in danger of not removing a sufficient amount of tissue
surrounding lesion 420, as defined by tissue margin 420A, computer
340 is able to provide an alarm to alarm device 360 to alert the
physician that is performing the procedure of the particular
situation.
[0020] Thus, through utilization of system 30, the physician is
able to objectively determine the amount of tissue that is to be
removed when preforming the procedure. This provides advantages
over the currently known methods and apparatuses that are utilized
by surgeons who perform these procedures. As discussed previously,
today, a tissue-resectioning procedure is guided by the surgeon
based on whatever limited visual information is obtainable through
the vision system located at the distal end of the resection
catheter. Guiding the resection procedure in this manner is a very
subjective process and prone to error, with a danger of taking
either too much or too little tissue from around the lesion to be
removed.
[0021] In further describing the present invention, as described
previously, fluoroscope 310 is utilized to generate x-rays that are
directed through the patient's body and, thus, through lesion 420.
Whereas the present invention is described as utilizing an imaging
device which consists of a fluoroscope 310 and an x-ray imaging
sensor 320, any of a variety of different imaging devices may be
utilized in practicing the principles of the present invention. For
example, a magnetic resonance imaging device (MRI) could be
utilized in the present invention to provide an image of lesion 420
and resection device 100. Thus, the present invention is not
limited to utilizing a fluoroscope and x-ray energy in practicing
the present invention.
[0022] As described previously, lesion 420 absorbs a radiopaque die
which creates an image of the lesion on the x-ray imaging sensor
320 when lesion 420 is radiated by the x- rays emitted from
fluoroscope 310. The radiopaque die may be administered to lesion
420 through any of a variety of procedures and the present
invention is not limited to any particular procedure for
introducing the radiopaque die within lesion 420. For example, the
die could be administered either intravenously or topically to the
lesion site. Similarly, the operating end, or distal end, of
resection device 100 could also contain a radiopaque die on it.
This would also allow for the position of the resection device to
be detected by the x-ray imaging sensor 320 when radiated by
fluoroscope 310.
[0023] X-ray imaging sensor 320 detects the x-rays generated by
fluoroscope 310 and is thus able to create an image of lesion 420
and resection device 100. Image information detected by x-ray
imaging sensor 320 for both lesion 420 and resection device 100 is
provided to video processing electronics 330. Video processing
electronics 330 processes the image information received from
imaging sensor 320 and provides this processed, digitized image
data to computer 340.
[0024] Computer 340 may be any of a variety of processing devices
that are capable of processing electronic information, either in a
digital or analog format. For example, computer 340 could be a
personal computer. Computer 340 contains software that is able to
define a tissue margin 420A around lesion 420. As described
previously, tissue margin 420A defines a sufficient area of tissue
around lesion 420 such that if the surgeon removes lesion 420 and
the tissue surrounding lesion 420 defined by tissue margin 420A,
enough tissue is removed from around lesion 420 to help ensure that
all of the diseased tissue is removed from body organ 410.
Additionally, removal of the surrounding tissue defined by tissue
margin 420A also helps to ensure that too much healthy tissue is
not removed from body organ 410. Thus, computer 340 defines the
tissue margin that is to be removed from a tubular body organ when
removing a lesion from the tubular organ during a resection
procedure.
[0025] As described previously, computer 340 is provided with
digitized image data of lesion 420 within body organ 410 such that
computer 340 is able to determine the position, and thus the
boundaries, of lesion 420 within tubular body organ 410. By knowing
the position of lesion 420 within body organ 410, computer 340 is
able to define tissue margin 420A around lesion 420. Any number of
different methodologies may be utilized to define tissue margin
420A around lesion 420 and the present invention is not limited to
any particular methodology. All that is required is that an
objectively determined tissue margin is defined around the lesion
to be removed such that the surgeon performing the procedure is
able to perform the procedure while considering the defined tissue
margin.
[0026] An exemplary methodology for determining tissue margin 420A
around lesion 420 is to utilize a pre-selected absolute measure of
tissue. For example, computer 340 could define tissue margin 420A
such that the tissue margin consists of a one-inch boundary of
tissue extending from the outer boundaries of lesion 420.
Alternatively, computer 340 could define tissue margin 420A as
being a measure of tissue that is a pre-selected percentage of a
physical dimension of lesion 420. For example, if lesion 420 has a
thickness of one-inch, computer 340 could define the tissue margin
420A such that the margin extends 100% of the thickness of lesion
420 from the outer boundaries of lesion 420, which in this example
would result in a one-inch tissue margin. Thus, tissue margin 420A
would be defined to encompass a boundary of one-inch of tissue that
surrounded lesion 420.
[0027] Whereas two alternative methodologies for defining tissue
margin 420A are provided above, as stated previously, any number of
methodologies can be utilized for defining tissue margin 420A and
the present invention is not limited to any particular methodology.
Computer 340 may utilize any methodology for defining a tissue
margin around a lesion based on the image data of the lesion
received from the video processing electronics. The surgeon
performing the procedure may selectively set the parameters for
defining the tissue margin, based upon considerations of the
particular procedure being performed, by inputting the parameters'
definitions into computer 340.
[0028] Once computer 340 has defined tissue margin 420A around
lesion 420, computer 340 provides this defined tissue margin 420A
to video display 350. Video display 350 displays the lesion 420,
the defined tissue margin 420A around the lesion, and the position
of resection device 100. Thus, video display 350 provides a visual
presentation that the surgeon can monitor while performing the
resection procedure and can utilize to operate the resection device
100 such that sufficient tissue defined by tissue margin 420A is
removed when removing lesion 420. Whereas video display 350 is
illustrated as being a separate element from computer 340, the
video display may be integrated into the computer and, thus,
separate structural elements are not required for these
components.
[0029] One methodology that the surgeon can utilize when practicing
the present invention is to visually observe the defined tissue
margin 420A around lesion 420 when operating resection device 100.
The surgeon is able to remove the proper amount of tissue from
tubular organ 410 by visually observing the lesion 420, the defined
tissue margin 420A, and the resection device 100 when performing
the resection procedure. By visually observing the position of the
resection device 100 relative to the lesion 420 and tissue margin
420A during the procedure, the surgeon can ensure that the proper
amount of tissue, as defined by tissue margin 420A, is removed from
the tubular organ.
[0030] Because computer 340 is also detecting the position of
resection device 100 as resection device 100 is performing the
procedure, if the resection device 100 is operated by the surgeon
such that the surgeon is either taking too much tissue or not
taking enough tissue, as defined by tissue margin 420A, computer
340 can provide an alarm to alert the surgeon of the error.
Computer 340 is coupled to alarm device 360 and may provide either
an audible alarm that will sound on alarm device 360 or could
provide a signal to alarm device 360 which would be visually
displayed on video display 350. Thus, as the surgeon is watching
the video presentation of the procedure on video display 350, if
the surgeon is operating resection device 100 such that it is not
removing tissue as defined by tissue margin 420A, an alarm can be
provided to alert the physician of this error.
[0031] Whereas the above embodiment describes a component for
generating an alarm, i.e., alarm device 360, that is a separate
component, it is not required that the alarm function be performed
by a component separate from either computer 340 or video display
350. The principles of the present invention may be practiced by
including the functionality of the alarm device in either computer
340 and/or video display 350. Thus, the alarm function can be
performed by a software module contained in any of the other
components of the present invention.
[0032] In continuing with the description of the methodologies of
the present invention, as described above, the surgeon performing
the procedure may visually monitor video display 350 to control his
or her operation of resection device 100. Alternatively, as is
illustrated in FIG. 3, computer 340 can also be directly coupled to
resection device 100. Thus, computer 340 can directly control
resection device 100. For example, rather than having to rely on
the surgeon visually monitoring the position of resection device
100 with respect to the defined tissue margin 420A on video display
350, if computer 340 detects an error in the physician's
positioning of resection device 100 outside of defined tissue
margin 420A, i.e., too much tissue is being removed, computer 340
could be programmed to disable resection device 100 in this
situation. Thus, if computer 340 determines that resection device
100 is being operated such that tissue outside of defined tissue
margin 420A is being removed, computer 340 can provide a signal to
resection device 100 to disable resection device 100. For example,
the resection device could be disabled such that its head assembly
could not be opened to receive tissue within it, and/or the cutting
blade could be retracted such that it could no longer cut tissue,
and/or the suction could be disabled, and/or head-actuating handle
150 could be disabled. These, or any of a variety of other
methodologies, could be utilized to disable resection device 100.
Thus, due to computer 340 disabling resection device 100 if the
resection device is mis-positioned, the physician is not physically
able to remove too much tissue from around lesion site 420. In
addition to disabling resection device 100 in this circumstance
where too much tissue is about to be removed, computer 340 could
also provide the visual and/or audible alarms as previously
described.
[0033] Whereas it was described above that computer 340 disables
resection device 100 if too much tissue was being removed, computer
340 could also disable resection device 100 if too little tissue
was also being removed.
[0034] As described above, in an embodiment of the present
invention, computer 340 is able to control the operation of
resection device 100 by monitoring the positions of the resection
device 100, the lesion 420, and the defined tissue margin 420A
around lesion 420.
[0035] As is further illustrated in FIG. 3, computer 340 can also
be coupled to fluoroscope 310. Thus, based on the quality of the
image data received by computer 340 from video processing
electronics 330, computer 340 may control fluoroscope 310 in order
to receive a better quality of image data. Computer 340 can control
fluoroscope 310 in order to attempt to obtain better quality image
data by any of a variety of different methodologies. For example,
computer 340 could physically alter the positioning of fluoroscope
310 such that better quality image data is received or computer 340
could alter the x-ray dosage delivered by fluoroscope 310. Thus,
computer 340 is able to control fluoroscope 310 in order to provide
image data of a higher quality than that possibly originally
received from video processing electronics 330.
[0036] Thus, as described above, the apparatuses and methods of the
present invention can be utilized by a surgeon to guide the surgeon
in the resectioning procedure. With knowledge of the
objectively-defined tissue margins of the lesions, the system
monitors the position of the resectioning catheter relative to the
tissue margins and warns the surgeon, through either audible alarms
and/or visual queues on a video monitor, if either too much or too
little healthy tissue is being taken. In another embodiment of the
invention, as described above, the system is able to control the
resectioning catheter, preventing it from cutting unless proper
tissue margins are being maintained.
[0037] Whereas fluoroscopy has been previously known in assisting
surgeons to visualize a treatment site during orthopedic surgery,
it is not known to use such a system with a resection procedure.
The present invention is able to safely reduce the amount of
healthy tissue that is resected with the diseased tissue while it
increases the chances of resecting the entire lesion in a single
procedure so that repeat procedures are not necessary. This reduces
cost and discomfort to the patient as well as reducing the chances
for metastasis of cancerous tissue by reducing the amount of damage
to the lesion during its resection.
[0038] Whereas the previously described embodiments of the present
invention would possibly provide a two-dimensional image, it is
also possible within the present invention to add a secondary
imaging device, e.g., a second x-ray source, and combine the data
of the two x-ray sources to create 3-D imagery. U.S. Pat. Nos.
5,772,594 and 5,799,055 describe fluoroscopy in medical procedures
and are incorporated herein by reference.
[0039] The apparatuses and methods of the present invention can be
utilized with any of a variety of different resection devices and
the present invention is not limited to any particular resection
device in practicing the present invention, including the
embodiment described in FIGS. 1 and 2 with or without the vision
chip and light source. For example, a resection device as described
in U.S. Pat. No. 5,868,760, which is incorporated herein by
reference, may be utilized when practicing the present invention.
Additionally, the resection device described in U.S. patent
application Ser. No. 09/100,393 filed on Jun. 19, 1998, now issued
as U.S. Pat. No. 6,126,058, which is also incorporated herein by
reference, could also be utilized when practicing the present
invention. Again, any of a variety of known resection devices can
be utilized in the present invention.
[0040] More specifically, the present invention may be utilized
with a flexible endoscopic resection system including a flexible
endoscope slidably received through at least a portion of a
stapling mechanism comprising an anvil and a stapling head mounted
to the anvil so that the anvil and the stapling head are moveable
with respect to one another between a tissue receiving position and
a stapling position. A position adjusting mechanism is provided for
moving the anvil and the stapling head between the tissue receiving
and stapling positions and a staple firing mechanism sequentially
fires a plurality of staples from the stapling head across the gap
against the anvil and through any tissue received in the gap and a
knife cuts a portion of tissue received within the gap. A control
unit which remains outside the body is coupled to the stapling
mechanism for controlling operation of the position adjusting
mechanism and the staple firing mechanism. The endoscope is
inserted into a naturally-occurring body orifice to locate a
lesion, for example, in a tubular organ under visual observation
(usually while insufflating the organ). Once the lesion has been
located, a working head assembly including a stapling mechanism and
an anvil is slidably advanced along the endoscope into the tubular
organ until the working head assembly is in a desired position
adjacent to the lesion. Alternatively, the working head assembly
may be detachably coupled to a distal end of the endoscope, and the
entire arrangement may then be inserted into the body orifice under
visual observation.
[0041] The disclosed embodiments are illustrative of the various
ways in which the present invention may be practiced. Other
embodiments can be implemented by those skilled in the art without
departing from the spirit and scope of the present invention.
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