Note: Descriptions are shown in the official language in which they were submitted.
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METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF
A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED
VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE
SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE
SAME
Reference To Pending Prior Patent Applications
This patent application:
(i) is a continuation-in-part of pending prior U.S. Patent Application
Serial No. 14/619,845, filed 02/11/2015 by Cornell University and John
Frederick
Cornhill et al. for METHOD AND APPARATUS FOR MANIPULATING THE
SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE
INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED
ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS
RELATIVE TO THE SAME (Attorney's Docket No. CORN-34), which patent
application claims benefit of prior U.S. Provisional Patent Application Serial
No.
61/938,446, filed 02/11/2014 by Cornell University and John Frederick Cornhill
et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE
WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE
INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED
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ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS
RELATIVE TO THE SAME (Attorney's Docket No. CORN-34 PROV); and
(ii) claims benefit of pending prior U.S. Provisional Patent Application
Serial No. 62/446,167, filed 01/13/2017 by Cornell University and Jeffrey
Milsom et al. for BALLOON TISSUE RETRACTION USING HOOP AND
CLIP WITH VARIABLE LENGTH CAPABILITY, WITH SPECIMEN
RETRIEVAL POUCH IN BALLOON (Attorney's Docket No. CORN-43
PROV).
The three (3) above-identified patent applications are hereby incorporated
1 0 herein by reference.
Field Of The Invention
This invention relates to surgical methods and apparatus in general, and
more particularly to surgical methods and apparatus for manipulating the side
wall of a body lumen and/or body cavity so as to provide increased
visualization
of the same and/or increased access to the same, and/or for stabilizing
instruments
relative to the same.
Background Of The Invention
The human body comprises many different body lumens and body
cavities. By way of example but not limitation, the human body comprises body
lumens such as the gastrointestinal (GI) tract, blood vessels, lymphatic
vessels,
the urinary tract, fallopian tubes, bronchi, bile ducts, etc. By way of
further
example but not limitation, the human body comprises body cavities such as the
head, chest, abdomen, nasal sinuses, bladder, cavities within organs, etc.
In many cases it may be desirable to endoscopically examine and/or treat a
disease process or abnormality which is located within, or on the side wall
of, a
body lumen and/or body cavity. By way of example but not limitation, it may be
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desirable to examine the side wall of the gastrointestinal tract for lesions
and, if a
lesion is found, to biopsy, remove and/or otherwise treat the lesion.
The endoscopic examination and/or treatment of the side wall of a body
lumen and/or body cavity can be complicated by the anatomic configuration
(both
regional and local) of the side wall of the body lumen and/or body cavity,
and/or
by the consistency of the tissue making up the side wall of the body lumen
and/or
body cavity, and/or by the tethering of the side wall of the body lumen and/or
body cavity to other anatomical structures.
By way of example but not limitation, the intestine is an elongated tubular
1 0 organ having an inner lumen and is characterized by frequent turns
(i.e., the
regional anatomic configuration of the intestine) and a side wall
characterized by
numerous folds (i.e., the local anatomic configuration of the intestine), with
the
side wall tissue having a relatively soft, pliable consistency, and with the
colon in
particular being tethered to the abdomen and/or other abdominal structures via
soft tissue. It can be difficult to fully visualize the side wall of the
intestine,
and/or to treat a lesion formed on the side wall of the intestine, due to this
varying
side wall anatomic configuration (both regional and local), its relatively
soft,
pliable consistency, and its tethering to other anatomical structures via soft
tissue.
By way of example but not limitation, in the case of colonoscopies, it has
been
found that approximately 5-40% of patients have an anatomic configuration
(regional and/or local) of the side wall, and/or a tissue consistency, and/or
colon
tethering to other anatomical structures, which makes it difficult to fully
visualize
the anatomy (including pathologic conditions of that anatomy, such as polyps
or
tumors) using conventional endoscopes, and/or to fully access the anatomy
using
instruments introduced through conventional endo scopes.
In addition to the foregoing, it has also been found that some body lumens
and/or body cavities can spasm and/or contract spontaneously but especially
when
an endoscope or other instrument is inserted into the body lumen and/or body
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cavity. This spasming and/or contraction can cause the body lumen and/or body
cavity to constrict and/or otherwise move and/or change its configuration,
which
can further complicate and/or compromise endoscopic visualization of the
anatomy, and/or further complicate and/or compromise access to the anatomy
using instruments introduced through conventional, flexible endoscopes. In
addition, during examination of the colon, which is typically conducted while
both inserting and withdrawing the endoscope through the colon, the endoscope
may grip and/or otherwise gather the colon during insertion and withdrawal and
then suddenly slip and release the colon. This results in the endoscope moving
1 0 quickly past significant lengths of the colon, thereby making accurate
examination of the colon challenging.
It would, therefore, be highly advantageous to provide novel apparatus
capable of manipulating the side wall of a body lumen and/or body cavity so as
to
better present the side wall tissue (including visualization of areas
initially hidden
or outside the field of view) for examination and/or treatment during an
endoscopic procedure.
It would also be highly advantageous to provide novel apparatus capable
of steadying and/or stabilizing the distal tips and/or working ends of
instruments
(e.g., endoscopes, articulating and/or non-articulating devices such as
graspers,
2 0 cutters or dissectors, cauterizing tools, ultrasound probes, etc.)
inserted into a
body lumen and/or body cavity with respect to the side wall of the body lumen
and/or body cavity, whereby to facilitate the precision use of those
instruments.
Among other things, it would be highly advantageous to provide novel
apparatus capable of steadying and/or stabilizing the distal tips and/or
working
ends of endoscopes (and hence also steadying and/or stabilizing the distal
tips
and/or working ends of other instruments inserted through the working channels
of those endoscopes, such as graspers, cutters or dissectors, cauterizing
tools,
ultrasound probes, etc.).
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And it would be highly advantageous to provide novel apparatus capable
of steadying and/or stabilizing the distal tips and/or working ends of
instruments
(such as graspers, cutters or dissectors, cauterizing tools, ultrasound
probes, etc.)
advanced to the surgical site by means other than through the working channels
of
5 endoscopes.
It would also be highly advantageous to be able to straighten bends, "iron
out" inner luminal surface folds and create a substantially static or stable
side wall
of the body lumen and/or body cavity, whereby to enable more precise visual
examination (including visualization of areas initially hidden or outside the
field
1 0 of view) and/or therapeutic intervention.
Summary Of The Invention
The present invention comprises the provision and use of novel apparatus
for manipulating the side wall of a body lumen and/or body cavity so as to
better
present the side wall tissue (including visualization of areas initially
hidden or
outside the field of view) for examination and/or treatment during an
endoscopic
procedure.
The present invention also comprises the provision and use of novel
apparatus capable of steadying and/or stabilizing the distal tips and/or
working
2 0 ends of instruments (e.g., endoscopes, articulating and/or non-
articulating devices
such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes,
etc.)
inserted into a body lumen and/or body cavity with respect to the side wall of
the
body lumen and/or body cavity, whereby to facilitate the precision use of
those
instruments.
Among other things, the present invention comprises the provision and use
of novel apparatus capable of steadying and/or stabilizing the distal tips
and/or
working ends of endoscopes (and hence also steadying and/or stabilizing the
distal tips and/or working ends of other instruments inserted through the
working
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channels of those endoscopes, such as graspers, cutters or dissectors,
cauterizing
tools, ultrasound probes, etc.).
And the present invention comprises the provision and use of novel
apparatus capable of steadying and/or stabilizing the distal tips and/or
working
ends of instruments (such as graspers, cutters or dissectors, cauterizing
tools,
ultrasound probes, etc.) advanced to the surgical site by means other than
through
the working channels of endoscopes.
And the present invention comprises the provision and use of novel
apparatus capable of straightening bends, "ironing out" folds and creating a
1 0 substantially static or stable side wall of the body lumen and/or body
cavity which
enables more precise visual examination (including visualization of areas
initially
hidden or outside the field of view) and/or therapeutic intervention.
In one preferred form of the present invention, there is provided apparatus
comprising:
a sleeve adapted to be slid over the exterior of an endoscope;
a proximal balloon secured to said sleeve;
an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a push tube slidably mounted to said sleeve; and
2 0 a distal balloon secured to the distal end of said push tube, the
interior of
said distal balloon being in fluid communication with said push tube, wherein
said
distal balloon is capable of assuming a deflated condition and an inflated
condition, and further wherein when said distal balloon is in its deflated
condition,
an axial opening extends therethrough, said axial opening being sized to
receive
the endoscope therein, and when said distal balloon is in its inflated
condition,
said axial opening is closed down.
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In another preferred form of the present invention, there is provided a
method for performing a procedure in a body lumen and/or body cavity, said
method comprising:
providing apparatus comprising:
a sleeve adapted to be slid over the exterior of an endoscope;
a proximal balloon secured to said sleeve;
an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a push tube slidably mounted to said sleeve; and
1 0 a distal balloon secured to the distal end of said push
tube, the
interior of said distal balloon being in fluid communication with said push
tube,
wherein said distal balloon is capable of assuming a deflated condition and an
inflated condition, and further wherein when said distal balloon is in its
deflated
condition, an axial opening extends therethrough, said axial opening being
sized
to receive the endoscope therein, and when said distal balloon is in its
inflated
condition, said axial opening is closed down;
positioning said apparatus in the body lumen and/or body cavity;
inflating said proximal balloon;
advancing said push tube distally;
2 0 inflating said distal balloon; and
performing the procedure.
In another preferred form of the present invention, there is provided
apparatus comprising:
a sleeve adapted to be slid over the exterior of an endoscope, said sleeve
comprising a passageway formed integral with said sleeve and a lumen formed
integral with said sleeve for receiving an instrument;
a proximal balloon secured to said sleeve;
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an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a push tube slidably mounted in said passageway of said sleeve; and
a distal balloon secured to the distal end of said push tube, the interior of
said distal balloon being in fluid communication with said push tube.
In another preferred form of the present invention, there is provided a
method for performing a procedure in a body lumen and/or body cavity, said
method comprising:
providing apparatus comprising:
1 0 a sleeve adapted to be slid over the exterior of an
endoscope, said
sleeve comprising a passageway formed integral with said sleeve and a lumen
formed integral with said sleeve for receiving an instrument;
a proximal balloon secured to said sleeve;
an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a push tube slidably mounted in said passageway of said sleeve;
and
a distal balloon secured to the distal end of said push tube, the
interior of said distal balloon being in fluid communication with said push
tube;
positioning said apparatus in the body lumen and/or body cavity;
inflating said proximal balloon;
advancing said push tube distally;
inflating said distal balloon; and
performing the procedure.
In another preferred form of the present invention, there is provided
apparatus comprising:
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a sleeve adapted to be slid over the exterior of an endoscope so as to
substantially cover the endoscope from a point adjacent to the distal end of
the
endoscope to a point adjacent to the handle of the endoscope;
a proximal balloon secured to said sleeve;
an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a push tube slidably mounted to said sleeve; and
a distal balloon secured to the distal end of said push tube, the interior of
said distal balloon being in fluid communication with said push tube.
1 0 In another preferred form of the present invention, there is
provided a
method for performing a procedure in a body lumen and/or body cavity, said
method comprising:
providing apparatus comprising:
a sleeve adapted to be slid over the exterior of an endoscope so as
to substantially cover the endoscope from a point adjacent to the distal end
of the
endoscope to a point adjacent to the handle of the endoscope;
a proximal balloon secured to said sleeve;
an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
2 0 a push tube slidably mounted to said sleeve; and
a distal balloon secured to the distal end of said push tube, the
interior of said distal balloon being in fluid communication with said push
tube;
positioning said apparatus in the body lumen and/or body cavity;
inflating said proximal balloon;
advancing said push tube distally;
inflating said distal balloon; and
performing the procedure.
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In another preferred form of the present invention, there is provided
apparatus comprising:
a sleeve adapted to be slid over the exterior of an endoscope;
a proximal balloon secured to said sleeve;
5 an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a pair of push tubes slidably mounted to said sleeve; and
a distal balloon secured to the distal ends of said pair of push tubes, the
interior of said distal balloon being in fluid communication with said pair of
push
10 tubes.
In another preferred form of the present invention, there is provided a
method for performing a procedure in a body lumen and/or body cavity, said
method comprising:
providing apparatus comprising:
a sleeve adapted to be slid over the exterior of an endoscope;
a proximal balloon secured to said sleeve;
an inflation/deflation tube carried by said sleeve and in fluid
communication with the interior of said proximal balloon;
a pair of push tubes slidably mounted to said sleeve; and
2 0 a distal balloon secured to the distal ends of said pair of
push tubes,
the interior of said distal balloon being in fluid communication with said
pair of
push tubes;
positioning said apparatus in the body lumen and/or body cavity;
inflating said proximal balloon;
advancing said pair of push tubes distally;
inflating said distal balloon; and
performing the procedure.
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In another preferred form of the present invention, there is provided an
endoscopic tissue retraction system comprising:
an element configured to be movably mounted to an endoscope; and
a connector configured to be secured to the element and to the tissue
which is to be retracted.
In another preferred form of the present invention, there is provided a
method for endoscopically retracting tissue, the method comprising:
positioning an endoscope and an element movably mounted to the
endoscope adjacent to tissue which is to be retracted;
1 0 securing a connector to the element and to the tissue which is to
be
retracted; and
urging the tissue away from the endoscope using the connector.
In another preferred form of the present invention, there is provided
apparatus for endoscopic tissue retrieval, the apparatus comprising:
a balloon configured to be movably mounted to an endoscope; and
an eyelet formed on the balloon.
In another preferred form of the present invention, there is provided a
method for endoscopically retracting tissue, the method comprising:
positioning an endoscope and an element movably mounted to the
2 0 endoscope adjacent to tissue which is to be retracted, wherein a
connector is
secured to the element;
securing the connector to the tissue which is to be retracted; and
urging the tissue away from the endoscope using the connector.
In another preferred form of the present invention, there is provided a
method for endoscopically retracting tissue, the method comprising:
positioning an endoscope and an element movably mounted to the
endoscope adjacent to tissue which is to be retracted;
securing the tissue which is to be retracted to the element; and
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urging the tissue away from the endoscope by moving the element.
In another preferred form of the present invention, there is provided
apparatus for endoscopic tissue retrieval, the apparatus comprising:
a balloon configured to be movably mounted to an endoscope, wherein the
balloon is capable of assuming a deflated condition and an inflated condition,
and
further wherein when the balloon is in its deflated condition, an axial
opening
extends therethrough, and when the balloon is in its inflated condition, the
axial
opening is closed down; and
a flap mounted in the axial opening of the balloon so as to form, in
conjunction with the surrounding portions of the balloon, a concave pouch for
receiving dissected tissue.
In another preferred form of the present invention, there is provided a
method for retrieving endoscopic tissue, the method comprising:
positioning a balloon assembly distal to the tissue which is to be retrieved,
the balloon assembly being movably mounted to an endoscope and the balloon
assembly comprising (i) a balloon capable of assuming a deflated condition and
an inflated condition, wherein when the balloon is in its deflated condition,
an
axial opening extends therethrough, and when the balloon is in its inflated
condition, the axial opening is closed down, and (ii) a flap mounted in the
axial
opening of the balloon so as to form, in conjunction with the surrounding
portions
of the balloon, a concave pouch for receiving the tissue which is to be
retrieved;
positioning the tissue which is to be retrieved into the concave pouch; and
withdrawing the balloon assembly proximally so as to retrieve the tissue
received within the concave pouch.
Brief Description Of The Drawings
These and other objects and features of the present invention will be more
fully disclosed or rendered obvious by the following detailed description of
the
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preferred embodiments of the invention, which is to be considered together
with
the accompanying drawings wherein like numbers refer to like parts and further
wherein:
Fig. 1 is a schematic view showing novel apparatus formed in accordance
with the present invention, wherein the novel apparatus comprises, among other
things, a sleeve for disposition over the end of an endoscope, an aft balloon
mounted to the sleeve, a pair of push tubes slidably mounted to the sleeve, a
fore
balloon mounted to the distal end of the push tubes, and a push tube handle
mounted to the proximal ends of the push tubes;
Figs. 2-4 are schematic views showing various dispositions of the fore
balloon relative to the aft balloon;
Fig. 5 is a schematic view showing further details of the distal end of the
apparatus shown in Fig. 1;
Fig. 6 is a section view taken along line 6-6 of Fig. 5;
Figs. 7 and 8 are schematic views showing further details of the fore
balloon;
Fig. 8A is a schematic view showing the push tube handle;
Figs. 9 and 10 are schematic views showing construction details of the
fore balloon;
Fig. 11 is a schematic view showing one form of inflation mechanism
provided in accordance with the present invention;
Fig. 11A is a schematic view showing another form of inflation
mechanism provided in accordance with the present invention;
Figs. 12 and 13 are schematic views showing another form of inflation
mechanism provided in accordance with the present invention;
Fig. 14 is a schematic view showing relief valves which may be used to
ensure that the pressure within the fore balloon and/or aft balloon does not
exceed
a predetermined level;
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Fig. 15 is a schematic view showing a retraction system which may be
used to take up slack in a flexible tube of the apparatus shown in Fig. 1;
Figs. 16-30 are schematic views showing preferred ways of using the
apparatus of Fig. 1;
Fig. 30A is a schematic view showing an alternative construction for the
push tubes and push tube handle of the present invention;
Fig. 31 is a schematic view showing another form of the sleeve, wherein
the sleeve comprises additional lumens for receiving instruments;
Figs. 32-35 are schematic views showing how instruments may be
advanced through the additional lumens of the sleeve;
Fig. 36 is a schematic view showing instrument guide tubes which may be
disposed in the additional lumens of the sleeve, wherein instruments may be
advanced through the instrument guide tubes;
Figs. 37-42 are schematic views showing an endoscopic tissue retraction
system formed in accordance with the present invention;
Figs. 43-45 are schematic views showing another endoscopic tissue
retraction system formed in accordance with the present invention;
Fig. 46 is a schematic view showing still another endoscopic tissue
retraction system formed in accordance with the present invention;
2 0 Fig. 47 is a schematic view showing yet another endoscopic tissue
retraction system formed in accordance with the present invention;
Fig. 48 is a schematic view showing another endoscopic tissue retraction
system formed in accordance with the present invention;
Fig. 49 is a schematic view showing still another endoscopic tissue
retraction system formed in accordance with the present invention;
Fig. 50 is a schematic view showing yet another endoscopic tissue
retraction system formed in accordance with the present invention;
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Figs. 51 and 52 are schematic views showing another endoscopic tissue
retraction system formed in accordance with the present invention;
Figs. 52A and 52B are schematic views showing still another endoscopic
tissue retraction system formed in accordance with the present invention; and
5 Figs. 53-60 are schematic views showing an endoscopic tissue
retrieval
system formed in accordance with the present invention.
Detailed Description Of The Preferred Embodiments
The present invention comprises the provision and use of novel apparatus
10 for manipulating the side wall of a body lumen and/or body cavity so as
to better
present the side wall tissue (including visualization of areas initially
hidden or
outside the field of view) for examination and/or treatment during an
endoscopic
procedure.
(As used herein, the term "endoscopic procedure" is intended to mean
15 substantially any minimally-invasive or limited access procedure,
diagnostic
and/or therapeutic and/or surgical, for accessing,
endoluminally or transluminally or otherwise, the interior of a body lumen
and/or
body cavity for the purposes of viewing, biopsying and/or treating tissue,
including removing a lesion and/or resecting tissue, etc.)
The present invention also comprises the provision and use of novel
apparatus capable of steadying and/or stabilizing the distal tips and/or
working
ends of instruments (e.g., endoscopes, articulating and/or non-articulating
devices
such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes,
etc.)
inserted into a body lumen and/or body cavity with respect to the side wall of
the
body lumen and/or body cavity, whereby to facilitate the precision use of
those
instruments.
Among other things, the present invention comprises the provision and use
of novel apparatus capable of steadying and/or stabilizing the distal tips
and/or
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working ends of endoscopes (and hence also steadying and/or stabilizing the
distal tips and/or working ends of other instruments inserted through the
working
channels of those endoscopes, such as graspers, cutters or dissectors,
cauterizing
tools, ultrasound probes, etc.).
And the present invention comprises the provision and use of novel
apparatus capable of steadying and/or stabilizing the distal tips and/or
working
ends of instruments (such as graspers, cutters or dissectors, cauterizing
tools,
ultrasound probes, etc.) advanced to the surgical site by means other than
through
the working channels of endoscopes.
And the present invention comprises the provision and use of novel
apparatus capable of straightening bends, "ironing out" folds and creating a
substantially static or stable side wall of the body lumen and/or body cavity
which
enables more precise visual examination (including visualization of areas
initially
hidden or outside the field of view) and/or therapeutic intervention.
The Novel Apparatus
In accordance with the present invention, and looking now at Fig. 1, there
is shown novel apparatus 5 which is capable of manipulating (e.g.,
stabilizing,
straightening, expanding and/or flattening, etc.) the side wall of a body
lumen
2 0 and/or body cavity so as to better present the side wall tissue
(including
visualization of areas initially hidden or outside the field of view) for
examination
and/or treatment during an endoscopic procedure using an endoscope 10 (e.g.,
an
articulating endoscope), and/or for stabilizing the distal end of endoscope 10
and/or the distal tips and/or working ends of other instruments (e.g.,
graspers,
cutters or dissectors, cauterizing tools, ultrasound probes, etc., not shown
in Fig.
1).
More particularly, apparatus 5 generally comprises a sleeve 15 adapted to
be slid over the exterior of the shaft of endoscope 10, a proximal (or "aft")
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balloon 20 (the terms "proximal" and "aft" will hereinafter be used
interchangeably) secured to sleeve 15 near the distal end of the sleeve, and a
base
25 secured to sleeve 15 at the proximal end of the sleeve. Apparatus 5 also
comprises a pair of push tubes 30 slidably mounted to sleeve 15 as will
hereinafter be discussed, and a distal (or "fore") balloon 35 (the terms
"distal" and
"fore" will hereinafter be used interchangeably) secured to the distal ends of
push
tubes 30, such that the spacing between aft balloon 20 and fore balloon 35 can
be
adjusted by the physician (or other operator or user) by moving push tubes 30
relative to sleeve 15 (e.g., by advancing the two push tubes simultaneously at
push tube handle 37, see below). See Figs. 1 and 2-4. Apparatus 5 also
comprises an associated inflation mechanism 40 (Fig. 1) for enabling selective
inflation/deflation of one or both of aft balloon 20 and fore balloon 35 by
the
physician or (or other operator or user).
Looking now at Figs. 1-6, sleeve 15 generally comprises an elongated,
thin-walled tube configured to be slid over the exterior of the shaft of endo
scope
10 (e.g., retrograde from the distal tip of the endoscope) so as to make a
close fit
therewith, with the sleeve being sized and constructed so that it will slide
easily
back over the endoscope during mounting thereon (preferably with the scope
"dry") but will have sufficient residual friction (when gripped by the hand of
the
2 0 physician or other operator or user) with the outer surface of the
endoscope such
that the sleeve will remain in place to allow torqueing (i.e., rotational
turning) and
pushing/pulling of the endoscope during use (e.g., within the colon of a
patient).
In one preferred form of the invention, sleeve 15 can move circumferentially
to
some extent about endoscope 10 (and when gripped securely by the hand of the
physician or other operator or user, can rotate in conjunction with the shaft
of the
endoscope); but sleeve 15 can only move nominally in an axial direction
relative
to endoscope 10. Sleeve 15 is sized so that when its distal end is
substantially
aligned with the distal end of endoscope 10, sleeve 15 (in conjunction with
base
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25) will substantially cover the shaft of the endoscope. In any case, sleeve
15 is
sized so that when it is mounted to endoscope 10 and endoscope 10 is inserted
into a patient, sleeve 15 extends out of the body of the patient. In one
preferred
form of the invention, apparatus 5 is provided according to the particular
endoscope with which it is intended to be used, with apparatus 5 being sized
so
that when base 25 is in engagement with the handle of the endoscope, the
distal
end of sleeve 15 will be appropriately positioned at the distal end of the
endoscope, i.e., substantially aligned with the distal end of the endoscope or
slightly proximal to the distal end of the endoscope.
1 0 If desired, the distal end of sleeve 15 may be provided with a
radially-
inwardly-extending stop (not shown) to positively engage the distal end
surface of
endoscope 10, whereby to prevent the distal end of sleeve 15 from moving
proximally beyond the distal end surface of endoscope 10. Such a radially-
inwardly-extending stop can also assist in preventing "torque slip" of sleeve
15
relative to endoscope 10 during torqueing (i.e., rotational turning) of the
endoscope while within the colon, and/or "thrust slip" of sleeve 15 relative
to
endoscope 10 during forward pushing of the endoscope while within the colon.
Sleeve 15 preferably has a smooth outer surface so as to be non-traumatic
to tissue, and is preferably made of a highly flexible material such that the
sleeve
will not inhibit bending of the endoscope during use. In one preferred form of
the
invention, sleeve 15 comprises polyurethane, polyethylene, poly(vinyl
chloride)
(PVC), polytetrafluoroethylene (PTFE), etc., and is preferably transparent (or
at
least translucent) so as to allow distance markings on endoscope 10 to be
visualized through sleeve 15. And in one preferred form of the invention,
sleeve
15 preferably has nominal hoop strength, so that the physician (or other
operator
or user) can grip endoscope 10 through sleeve 15, e.g., so as to torque the
scope.
If desired, sleeve 15 can include a lubricious coating (e.g., a liquid such as
perfluoropolyether synthetic oil, a powder, etc.) on some or all of its
interior
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and/or exterior surfaces, so as to facilitate disposition of the sleeve over
the
endoscope and/or movement of apparatus 5 through a body lumen and/or body
cavity. Alternatively, sleeve 15 may be formed of a material which is itself
lubricious, e.g., polytetrafluoroethylene (PTFE), etc. It should be
appreciated that
the inside surface of sleeve 15 may include features (e.g., ribs) to prevent
the
sleeve from rotating relative to the endoscope during use.
If desired, a vacuum may be "pulled" between sleeve 15 and endoscope
10, whereby to secure sleeve 15 to endoscope 10 and minimize the profile of
sleeve 15. By way of example but not limitation, a vacuum may be introduced at
the proximal end of sleeve 15 (i.e., at base 25) or a vacuum may be introduced
at
a point intermediate sleeve 15. By way of further example but not limitation,
it
should also be appreciated that removal of sleeve 15 from endoscope 10 (e.g.,
at
the conclusion of a procedure) may be facilitated by introducing a fluid
(e.g., air
or a liquid lubricant) into the space between sleeve 15 and endoscope 10,
e.g., at
the proximal end of sleeve 15 (i.e., at base 25) or intermediate sleeve 15.
Still looking now at Figs. 1-6, aft balloon 20 is secured to sleeve 15 just
proximal to the articulating joint of the endoscope near to, but spaced from,
the
distal end of the sleeve. Aft balloon 20 is disposed concentrically about
sleeve
15, and hence concentrically about an endoscope 10 disposed within sleeve 15.
Thus, aft balloon 20 has a generally toroidal shape. Aft balloon 20 may be
selectively inflated/deflated by means of a proximal inflation/deflation tube
45
which has its distal end in fluid communication with the interior of aft
balloon 20,
and which has its proximal end in fluid communication with a fitting 46
mounted
to base 25. Fitting 46 is configured for connection to the aforementioned
associated inflation mechanism 40. Fitting 46 is preferably a luer-activated
valve,
allowing inflation mechanism 40 to be disconnected from fitting 46 without
losing pressure in aft balloon 20. Inflation/deflation tube 45 may be secured
to
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the exterior surface of sleeve 15 or, more preferably, inflation/deflation
tube 45
may be contained within a lumen 47 formed within sleeve 15.
Preferably aft balloon 20 is disposed a short distance back from the distal
end of sleeve 15, i.e., by a distance which is approximately the same as the
length
5 of the articulating portion of a steerable endoscope 10, such that the
articulating
portion of the steerable endoscope will be disposed distal to aft balloon 20
when
the steerable endoscope is disposed in sleeve 15. This construction allows the
flexible portion of the steerable endoscope to be articulated even when aft
balloon
20 has been inflated in the anatomy so as to stabilize the adjacent non-
articulating
10 portion of the endoscope relative to the anatomy, as will hereinafter be
discussed
in further detail. Thus, when inflated, aft balloon 20 provides a secure
platform
for maintaining endoscope 10 in a stable position within a body lumen or body
cavity, with endoscope 10 centered within the body lumen or body cavity. As a
result, endoscope 10 can provide improved visualization of the anatomy.
15 Furthermore, inasmuch as endoscope 10 is securely maintained within the
body
lumen or body cavity by the inflated aft balloon 20, instruments advanced
through
the internal lumens (sometimes referred to as the "working channel" or
"working
channels") of endoscope 10 will also be provided with a secure platform for
supporting those instruments within the body lumen or body cavity.
2 0 When aft balloon 20 is appropriately inflated, the aft balloon can
atraumatically engage and form a sealing relationship with the side wall of a
body
lumen within which apparatus 5 is disposed.
In one preferred form of the invention, aft balloon 20 is formed out of
polyurethane.
Base 25 is secured to the proximal end of sleeve 15. Base 25 engages
endoscope 10 and helps secure the entire assembly (i.e., apparatus 5) to
endoscope 10. Base 25 preferably comprises a substantially rigid or semi-rigid
structure which may be gripped by the physician (or other operator or user)
and
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pulled proximally, whereby to allow the physician (or other operator or user)
to
pull sleeve 15 over the distal end of endoscope 10 and then proximally back
along
the length of endoscope 10, whereby to mount sleeve 15 to the outer surface of
the shaft of the endoscope. In one preferred form of the invention, base 25 is
pulled proximally along the endoscope until base 25 seats against the handle
of
the endoscope, thereby prohibiting further proximal movement of base 25 (and
hence thereby prohibiting further proximal movement of sleeve 15). In one
preferred form of the invention, base 25 makes a sealing engagement with
endoscope 10.
1 0 Push tubes 30 are slidably mounted to sleeve 15, whereby the
distal ends
of the push tubes can be extended and/or retracted relative to sleeve 15
(e.g., by
advancing or withdrawing the push tubes via push tube handle 37, see below),
and
hence extended and/or retracted relative to the distal end of endoscope 10
which
is disposed in sleeve 15. Preferably, push tubes 30 are slidably disposed in
support tubes 50 which are secured to the outer surface of sleeve 15 or, more
preferably, are contained within lumens 52 formed within sleeve 15. Support
tubes 50 are preferably formed out of a low friction material (e.g.,
polytetrafluoroethylene, also known as "PTFE") so as to minimize resistance to
movement of push tubes 30 relative to support tubes 50 (and hence minimize
2 0 resistance to movement of push tubes 30 relative to sleeve 15). In this
respect it
should be appreciated that minimizing resistance to the movement of push tube
30
relative to support tubes 50 improves tactile feedback to the user when push
tubes
30 are being used to manipulate fore balloon 35. In one form of the invention,
support tubes 50 are flexible (so as to permit endoscope 10, and particularly
the
articulating portion of steerable endoscope 10, to flex as needed during the
procedure); however, support tubes 50 also provide some column strength. Thus,
when support tubes 50 are mounted within lumens 52 formed in sleeve 15, the
assembly of sleeve 15 and support tubes 50 is flexible yet has a degree of
column
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strength (whereas sleeve 15 alone is flexible but has substantially no column
strength). In the event that push tubes 30 are contained within lumens 52
formed
in sleeve 15, and in the event that support tubes 50 are not disposed between
push
tubes 30 and lumens 52, lumens 52 are preferably lubricated so as to minimize
friction between push tubes 30 and lumens 52.
The proximal ends of push tubes 30 are connected to push tube handle 37.
As a result of this construction, pushing distally on push tube handle 37
causes the
distal ends of push tubes 30 to move distally (at the same rate) relative to
sleeve
(whereby to move fore balloon 35 distally relative to aft balloon 20) and
10 pulling proximally on push tube handle 37 causes the distal ends of push
tubes 30
to retract proximally (at the same rate) relative to sleeve 15 (whereby to
move
fore balloon 35 proximally relative to aft balloon 20). Note that by moving
push
tubes 30 distally or proximally at the same rate, the distal ends of the push
tubes
are maintained parallel to each other. A clamp 53 (Figs. 12 and 15) is
provided at
15 base 25 for holding push tubes 30 in a selected disposition relative to
base 25 (and
hence in a selected disposition relative to sleeve 15).
Push tubes 30 are preferably formed out of a relatively flexible material
which provides good column strength, e.g., a thermoplastic polyethylene resin
such as IsoplastTm (available from The Lubrizol Corporation of Wickliffe,
Ohio),
polyethylene, polypropylene, nylon, etc. It should be appreciated that push
tubes
can comprise a single material or a plurality of materials, and that the
stiffness
of push tubes 30 can vary along their length. By way of example but not
limitation, the distal-most portion of push tubes 30 can be formed of the same
material as the remainder of the push tubes but have a lower modulus so as to
be
25 more flexible than the remainder of the push tubes, or the distal-most
portion of
push tubes 30 can comprise a different, more resilient flexible material. By
way
of example but not limitation, the distal-most portion of push tubes 30 can
comprise Nitinol. By way of further example but not limitation, the distal-
most
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portion of push tubes 30 can comprise a stainless steel coil covered with an
outer
jacket of polytetrafluoroethylene (PTFE), with the distal-most jacket/more-
proximal tubing together providing a sealed lumen for inflating/deflating fore
balloon 35. By forming push tubes 30 with distal ends which are more flexible
than the remainder of the push tubes, the push tubes 30 and fore balloon 35
can
together function as a lead (with a soft atraumatic tip) for apparatus 5 and
endoscope 10, as discussed further below.
In one preferred form of the invention, push tubes 30 are configured to
maintain a parallel disposition when they are in an unbiased state, i.e., when
no
1 0 force is being applied to push tubes 30. This is true regardless of the
state of
inflation or deflation of fore balloon 35.
The distal-most portion of push tubes 30 can be configured to bend
inwardly or outwardly if desired. With such a configuration, when the distal
tips
of push tubes 30 are maintained stationary (e.g., by an inflated fore balloon,
as
will hereinafter be discussed) and a sufficient distally-directed force is
applied to
push tubes 30, the middle portions of push tubes 30 (i.e., the portions
between the
inflated fore balloon 35 and sleeve 15) can bend or bow outwardly, whereby to
push outwardly on the side wall of the body lumen which apparatus 5 is
disposed
in, thereby providing a "tenting" effect on the side wall of the body lumen
and/or
body cavity in the space between aft balloon 20 and fore balloon 35. This
"tenting" effect can significantly enhance visibility and/or tissue stability
in the
area distal to endoscope 10, by pushing outwardly on the side wall of the body
lumen and/or body cavity in which apparatus 5 is disposed.
It should also be appreciated that by forming push tubes 30 out of a
flexible material, it is possible to manually adjust their position during use
(e.g.,
by using a separate tool, by torqueing the apparatus, etc.) so as to prevent
the push
tubes from interfering with visualization of the patient's anatomy and/or
interfering with diagnostic or therapeutic tools introduced into the space
between
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the fore and aft balloons. By way of example but not limitation, if apparatus
5 is
disposed in the anatomy in such a way that a push tube 30 blocks visual or
physical access to a target region of the anatomy, the flexible push tube 30
may be
moved out of the way by using a separate tool or instrument, or by rotating
the
apparatus with a torqueing motion so as to move the flexible push tube 30 out
of
the way, etc. By way of further example but not limitation, by constructing
push
tubes 30 so that they are circular and flexible and of a diameter
significantly
smaller than the round circumference of endoscope 10, the movement of the
round endoscope, when articulated, can simply push the push tubes out of the
way
1 0 and provides a unobstructed visual path to the tissue of interest.
It should also be appreciated that, if desired, push tubes 30 can be marked
with an indicator including distance markers (not shown in the figures), e.g.,
colored indicators or radiopaque indicators, so that a physician (or other
operator
or user) observing the surgical site via endoscope 10 or by radiological
guidance
(e.g., X-ray fluoroscopy) can ascertain the relative disposition of push tubes
30 at
the surgical site both longitudinally and/or circumferentially with respect to
the
side wall of the body lumen and/or other body cavity.
As will hereinafter be discussed in further detail, push tubes 30 are hollow,
and have their distal ends in fluid communication with the interior of fore
balloon
2 0 35 (Figs. 1-5, 7 and 8) and their internal lumens in fluid
communication with a
fitting 56 mounted to base 25. Fitting 56 is configured for connection to the
aforementioned associated inflation mechanism 40, in order that fore balloon
35
may be selectively inflated/deflated with air or other fluids (including
liquids).
Fitting 56 is preferably a luer-activated valve, allowing inflation mechanism
40 to
be disconnected from fitting 56 without losing pressure in fore balloon 35.
More particularly, in one preferred form of the present invention, and
looking now at Fig. 8A, push tube handle 37 comprises a hollow interior 57.
Push
tubes 30 are mounted to push tube handle 37 so that push tubes 30 will move in
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conjunction with push tube handle 37, and so that the hollow interiors of push
tubes 30 are in fluid communication with the hollow interior 57 of push tube
handle 37. Push tube handle 37 also comprises a fitting 58 which is in fluid
communication with hollow interior 57 of push tube handle 37. A flexible tube
5 59 connects fitting 58 with an internal chamber (not shown) in base 25,
with this
internal chamber in base 25 being in fluid communication with the
aforementioned fitting 56. As a result of this construction, when push tube
handle
37 is moved distally, fore balloon 35 is moved distally, and when push tube
handle 37 is moved proximally, fore balloon 35 is moved proximally.
1 0 Furthermore, when positive fluid pressure is applied to fitting 56 in
base 25,
positive fluid pressure is applied to the interior of fore balloon 35, whereby
to
inflate fore balloon 35, and when negative fluid pressure is applied to
fitting 56 in
base 25, negative fluid pressure is applied to the interior of fore balloon
35,
whereby to deflate fore balloon 35.
15 It should be appreciated that the provision of dual push tubes
provides
numerous advantages. By way of example but not limitation, the provision of
dual push tubes provides a symmetric force to fore balloon 35 when the fore
balloon is advanced distally into a body lumen, as will hereinafter be
discussed.
Furthermore, the provision of dual push tubes 30 provides equal outward forces
20 against the adjacent anatomy when the push tubes are employed to
straighten out
the anatomy in the area proximate the distal end of endoscope 10, thereby
enhancing visualization of, and/or access to, the anatomy, as will hereinafter
be
discussed. In addition, the provision of dual push tubes ensures that fore
balloon
remains centered on endoscope 10, thereby facilitating un-docking of fore
25 balloon 35 from endoscope 10 and re-docking of fore balloon 35 over
endoscope
10, as will hereinafter be discussed. In addition, the provision of dual push
tubes
30 helps ensure that fore balloon 35 is stable relative to the tip of the
endoscope,
minimizing rotational movement of the fore balloon when inflated. Furthermore,
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the provision of dual hollow push tubes provides a redundant air transfer
system
for inflating or deflating fore balloon 35.
Fore balloon 35 is secured to the distal ends of push tubes 30, whereby the
spacing between aft balloon 20 and fore balloon 35 can be adjusted by moving
push tubes 30 relative to sleeve 15, i.e., by moving push tube handle 37
relative to
sleeve 15. Furthermore, hollow push tubes 30 provide a conduit between the
interior of fore balloon 35 and fitting 56, whereby to permit selective
inflation/deflation of fore balloon 35 via fitting 56.
Significantly, fore balloon 35 is configured so that (i) when it is deflated
1 0 (or partially deflated) and it is in its "retracted" position relative
to sleeve 15 (Fig.
2), fore balloon 35 provides an axial opening 63 (Figs. 7, 8 and 10)
sufficient to
accommodate sleeve 15 and the shaft of endoscope 10 therein, whereby fore
balloon 35 can be "docked" over sleeve 15 and endoscope 10, and (ii) when fore
balloon 35 is in its "extended" position relative to sleeve 15 and is
appropriately
inflated (Fig. 4), axial opening 63 is closed down (and preferably completely
closed off). At the same time, when appropriately inflated, the fore balloon
can
atraumatically engage and form a sealing relationship with the side wall of a
body
lumen and/or body cavity within which apparatus 5 is disposed. Thus, when fore
balloon 35 is appropriately inflated, the fore balloon can effectively seal
the body
lumen and/or body cavity distal to fore balloon 35, by closing down axial
opening
63 and forming a sealing relationship with the side wall of the body lumen
and/or
body cavity within which apparatus 5 is disposed. In this way, when push tubes
are advanced distally so as to separate fore balloon 35 from aft balloon 20,
and
when fore balloon 35 and aft balloon 20 are appropriately inflated, the two
25 balloons will create a sealed zone therebetween (sometimes hereinafter
referred to
as "the therapeutic zone").
It will be appreciated that, when fore balloon 35 is reconfigured from its
deflated condition to its inflated condition, fore balloon 35 expands radially
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inwardly (so as to close down axial opening 63) as well as radially outwardly
(so
as to engage the surrounding tissue).
Thus it will be seen that fore balloon 35 has a "torus" shape when deflated
(to allow it to seat over the distal end of the endoscope) and a substantially
"solid"
shape when inflated (to allow it to close off a body lumen or body cavity).
To this end, and looking now at Figs. 9 and 10, fore balloon 35 is
preferably manufactured as a single construct comprising a body 67 having a
proximal opening 69 and a distal opening 71, a proximal extension 73 having a
"key-shaped" cross-section comprising lobes 74, and a distal extension 76
having
1 0 a circular cross-section. Note that lobes 74 are disposed on proximal
extension 73
with a configuration which matches the configuration of push tubes 30 (i.e.,
where apparatus 5 comprises two push tubes 30 diametrically opposed to one
another, proximal extension 73 will comprise two lobes 74 diametrically
opposed
to one another; where apparatus 5 comprises three push tubes 30 equally-
circumferentially-spaced about the perimeter of sleeve 15, proximal extension
73
will comprise three lobes 74 equally-circumferentially-spaced about the
perimeter
of proximal extension 73; where apparatus 5 comprises one push tube 30,
proximal extension 73 will comprise one lobe 74, etc. ¨ for the purposes of
the
present invention, proximal extension 73 and lobe(s) 74 may be collectively
2 0 referred to as having a "key-shaped" cross-section). During assembly,
push tubes
30 are seated in lobes 74 of proximal extension 73, proximal extension 73 is
everted into the interior of body 67 (with the interiors of hollow push tubes
30
being in fluid communication with the interior of body 67), and then distal
extension 76 is everted into the interior of proximal extension 73, whereby to
provide a fore balloon 35 having axial opening 63 extending therethrough, with
push tubes 30 being secured to fore balloon 35 and communicating with the
interior of fore balloon 35. Significantly, axial opening 63 is sized to
receive the
distal end of endoscope 10 therein. Also significantly, the formation of fore
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balloon 35 by the aforementioned process of everting proximal extension 73
into
the interior of body 67, and then everting distal extension 76 into the
interior of
proximal extension 73, provides multiple layers of balloon material around
push
tubes 30, thereby providing a more robust balloon construction. Among other
things, providing multiple layers of balloon material around push tubes 30
adds
cushioning to the distal ends of push tubes 30, thereby providing an even more
atraumatic distal tip to push tubes 30 and further ensuring that the distal
tips of
push tubes 30 do not damage the adjacent tissue.
In one preferred form of the invention, fore balloon 35 is formed out of
polyurethane.
It should be appreciated that when fore balloon 35 is in its deflated
condition, the material of fore balloon 35 substantially encompasses the
distal
ends of push tubes 30 (while still allowing push tubes 30 to be in fluid
communication with the interior of fore balloon 35), thereby providing an
atraumatic tip for advancing fore balloon 35 distally through a body lumen.
Furthermore, push tubes 30 and the deflated fore balloon 35 can, together,
essentially function as a soft-tipped lead for apparatus 5 and endoscope 10,
as
discussed further below (Fig. 20).
If desired, one or both of aft balloon 20 and fore balloon 35 can be marked
2 0 with an indicator (e.g., a color indicator or a radiopaque indicator)
so that a
physician (or other operator or user) observing the surgical site via
endoscope 10
or radiological guidance (e.g., X-ray fluoroscopy) can ascertain the
disposition of
one or both of the balloons at the surgical site.
Inflation mechanism 40 provides a means to selectively inflate aft balloon
20 and/or fore balloon 35.
In one preferred form of the present invention, and looking now at Figs. 1
and 11, inflation mechanism 40 comprises a single-line syringe inserter 140
comprising a body 145 and a plunger 150. Preferably a spring 153 is provided
in
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body 145 to automatically return plunger 150 at the end of its stroke. Syringe
inserter 140 is connected to one or the other of fittings 46, 56 via a line
155.
Thus, with this construction, when single-line syringe inserter 140 is to be
used to
inflate aft balloon 20, syringe inserter 140 is connected to fitting 46 via
line 155
so that the output of single-line syringe inserter 140 is directed to aft
balloon 20
(i.e., via proximal inflation/deflation tube 45). Correspondingly, when single-
line
syringe inserter 140 is to be used to inflate fore balloon 35, syringe
inserter 140 is
connected to fitting 56 via line 155 so that the output of single-line syringe
inserter 140 is directed to fore balloon 35 (i.e., via flexible tube 59 and
the hollow
1 0 interiors of push tubes 30).
In another preferred form of the present invention, inflation mechanism 40
comprises an elastic bulb 156 having a first port 157 and a second port 158. A
one-way valve 159 (e.g., a check valve) is disposed in first port 157 so that
air can
only pass through first port 157 when traveling in an outward direction.
Another
one-way valve 159 (e.g., a check valve) is disposed in second port 158 so that
air
can only pass through second port 158 when traveling in an inward direction.
When elastic bulb 156 is compressed (e.g., by hand), air within the interior
of
elastic bulb 156 is forced out first port 157; and when elastic bulb 156 is
thereafter released, air is drawn back into the interior of elastic bulb 156
through
second port 158.
As a result of this construction, when elastic bulb 156 is to be used to
inflate aft balloon 20, first port 157 is connected to fitting 46 via line 155
so that
the positive pressure output of elastic bulb 156 is directed to aft balloon
20.
Elastic bulb 156 may thereafter be used to deflate aft balloon 20, i.e., by
connecting second port 158 to fitting 46 via line 155 so that the suction of
elastic
bulb 156 is directed to aft balloon 20. Correspondingly, when elastic bulb 156
is
to be used to inflate fore balloon 35, first port 157 is connected to fitting
56 via
line 155 so that the positive pressure output of elastic bulb 156 is directed
to fore
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balloon 35. Elastic bulb 156 may thereafter be used to deflate fore balloon
35,
i.e., by connecting second port 158 to fitting 56 via line 155 so that the
suction of
elastic bulb 156 is directed to fore balloon 35.
Alternatively, and looking now at Figs. 12 and 13, a syringe 160 may be
5 used to inflate aft balloon 20 and/or fore balloon 35. Inflation
mechanism 160
comprises a body 161 and a plunger 162. Preferably a spring (not shown) is
provided in body 161 to automatically return plunger 162 at the end of its
power
stroke. Syringe 160 is connected to fittings 46, 56 via a line 163. With this
construction, syringe 160 comprises a valve 165 for connecting syringe 160 to
10 fore balloon 35 or aft balloon 20, and a valve 170 for selecting
inflation or
deflation of the connected-to balloon.
Thus, with this construction, when syringe 160 is to be used to inflate aft
balloon 20, valve 165 (a two-position valve that connects valve 170 to either
the
fore balloon or the aft balloon) is set so that the syringe 160 is connected
through
15 fitting 46 to aft balloon 20, and valve 170 (a 2-way crossover valve
which allows
the one-way valves to be arranged to inflate in one configuration and deflate
in
the other configuration) is set so that syringe 160 is providing inflation
pressure.
Thereafter, when aft balloon 20 is to be deflated, valve 170 is set to its
deflate
position.
20 Correspondingly, when syringe 160 is to be used to inflate fore
balloon 35,
valve 165 is set so that syringe 160 is connected through fitting 56 to fore
balloon
35, and valve 170 is set so that syringe 160 is providing inflation pressure.
Thereafter, when fore balloon 35 is to be deflated, valve 170 is set to its
deflate
position.
25 In yet another form of the invention, inflation mechanism 40 may
comprise an automated source of fluid pressure (either positive or negative),
e.g.,
an electric pump.
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If desired, and looking now at Fig. 14, a relief valve 175 can be connected
to the inflation/deflation line which connects to fore balloon 35 so as to
ensure
that the pressure within fore balloon 35 does not exceed a predetermined
level.
Similarly, and still looking now at Fig. 14, a relief valve 180 can be
connected to
the inflation/deflation line which connects to aft balloon 20 so as to ensure
that
the pressure within aft balloon 20 does not exceed a predetermined level.
Alternatively, and/or additionally, one or more pressure gauges 182 (Fig. 1
or Fig. 13) may be incorporated into the fluid line connected to aft balloon
20,
and/or the fluid line connected to fore balloon 35, whereby to provide the
1 0 physician (or other operator or user) with information relating to the
pressure
inside aft balloon 20 and/or fore balloon 35 so as to avoid over inflation
and/or to
help the physician (or other operator or user) ascertain the inflation state
of a
balloon during a procedure.
Furthermore, it will be appreciated that as fore balloon 35 moves between
its "retracted" position (Fig. 2) and its "extended" position (Fig. 4), the
flexible
tube 59 connecting push tubes 30 to base 25 (and hence to fitting 56) may
gather
about base 25, potentially interfering with the physician's (or other
operator's or
user's) actions. Accordingly, if desired, and looking now at Fig. 15, a
flexible
tube retraction system 185 may be provided (e.g., within base 25) to take up
slack
2 0 in flexible tube 59 when fore balloon 35 is extended.
Preferred Method Of Using The Novel Apparatus
Apparatus 5 may be used to manipulate, (e.g., stabilize, straighten, expand
and/or flatten, etc.) the side wall of a body lumen and/or body cavity so as
to
better present the side wall tissue (including visualization of areas
initially hidden
or outside the field of view) for examination and/or treatment during an
endoscopic procedure using endoscope 10, and/or to stabilize the distal tips
and/or
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working ends of instruments (e.g., graspers, cutters or dissectors,
cauterizing
tools, ultrasound probes, etc.), e.g., advanced into the therapeutic zone.
More particularly, in use, sleeve 15 is first mounted to endoscope 10 (Fig.
1). This may be accomplished by pulling base 25 proximally over the distal end
of endoscope 10 and then pulling proximally along the length of endoscope 10
until the distal end of sleeve 15 is substantially aligned with the distal tip
of
endoscope 10. At this point, aft balloon 20 is deflated, fore balloon 35 is
deflated,
and fore balloon 35 is docked over the distal end of endoscope 10. Endoscope
10
and apparatus 5 are ready to be inserted as a unit into the patient.
Looking next at Fig. 16, endoscope 10 and apparatus 5 are inserted as a
unit into a body lumen and/or body cavity of the patient. By way of example
but
not limitation, endoscope 10 and apparatus 5 are inserted as a unit into the
gastrointestinal (GI) tract of the patient. Endoscope 10 and apparatus 5 are
advanced along the body lumen and/or body cavity to a desired location within
the patient (Figs. 17 and 18).
When apparatus 5 is to be used (e.g., to manipulate the side wall of the
gastrointestinal tract so as to provide increased visualization of the same
and/or
increase access to the same, and/or for stabilizing instruments relative to
the
same), aft balloon 20 is inflated so as to stabilize apparatus 5 (and hence
endoscope 10) within the body lumen and/or body cavity. See Fig. 19. This may
be done using the aforementioned associated inflation mechanism 40.
In this respect it will be appreciated that inasmuch as the articulating
portion of the endoscope resides distal to aft balloon 20, the endoscope will
be
able to articulate distal to aft balloon 20 so as to facilitate visualization
of the
anatomy even after aft balloon 20 is inflated. Significantly, such
visualization is
enhanced, inasmuch as aft balloon 20 stabilizes endoscope 10 within the
gastrointestinal tract and distends the colon and increases the colon to a
fixed
diameter directly adjacent to aft balloon 20.
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Next, push tubes 30 are advanced distally in the body lumen and/or body
cavity (i.e., so as to move fore balloon 35 further ahead of aft balloon 20)
by
pushing distally on push tube handle 37. Thus, push tubes 30, and hence fore
balloon 35, move distally relative to endoscope 10 (which is stabilized in
position
within the gastrointestinal tract by the inflated aft balloon 20). Note that
the
deflated fore balloon 35 covers the distal ends of push tubes 30 during such
distal
advancement of fore balloon 35, thereby ensuring atraumatic advancement of
fore
balloon 35. Note that atraumatic advancement of fore balloon 35 may be further
enhanced by forming the distal ends of push tubes 30 out of a more resilient
material.
When push tubes 30 have advanced fore balloon 35 to the desired position
distal to endoscope 10, fore balloon 35 is inflated (Fig. 20) so as to secure
fore
balloon 35 to the anatomy. Again, this may be done using the aforementioned
associated inflation mechanism 40. As fore balloon 35 is inflated, the
inflated
fore balloon 35, the inflated aft balloon 20, and push tubes 30 will all
complement
one another so as to stabilize, straighten, expand and/or flatten the side
wall of the
body lumen and/or body cavity so as to better present the side wall tissue
(including visualization of areas initially hidden or outside the field of
view) for
examination and/or treatment during an endoscopic procedure using endoscope
2 0 10. In this respect it will be appreciated that the inflated fore
balloon 35 and the
inflated aft balloon 20 will together expand and tension the side wall of the
body
lumen and/or body cavity, and push tubes 30 will tend to straighten the
anatomy
between the two inflated balloons when the fore balloon is extended distally
from
the aft balloon. In this respect it will also be appreciated that once aft
balloon 20
and fore balloon 35 have both been inflated, fore balloon 35 will create a
substantially full-diameter seal across the body lumen and/or body cavity
(because the inflated fore balloon closes down the axial opening 63 extending
through the fore balloon when the fore balloon is in its deflated state), and
aft
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balloon 20 will cooperate with sleeve 15 and endoscope 10 to create another
substantially full-diameter barrier across the body lumen and/or body cavity.
Thus, the inflated fore balloon 35 and the inflated aft balloon 20 will
together
define a substantially closed region along the body lumen and/or body cavity
(i.e.,
an isolated therapeutic zone which prevents the passage of fluid and/or other
liquids by virtue of the air-tight seals established by the inflated fore
balloon 35
and aft balloon 20). The side wall of the body lumen and/or body cavity will
be
tensioned by inflation of fore balloon 35 and aft balloon 20, whereby to
better
present the side wall of the body lumen and/or body cavity for viewing through
endoscope 10.
It should be appreciated that the expansion and tensioning of the side wall
of the body lumen and/or body cavity effected by the inflated fore balloon 35,
the
inflated aft balloon 20, and push tubes 30, can be further enhanced by
advancing
the fore balloon when it is inflated and gripping the side wall of the body
lumen
and/or body cavity, whereby to tension the side wall of the body lumen and/or
body cavity.
Significantly, inasmuch as the inflated fore balloon 35 and the inflated aft
balloon 20 together define a substantially closed region along the body lumen
and/or body cavity (i.e., an isolated therapeutic zone), this region can then
be
2 0 inflated (Fig. 21) with a fluid (e.g., air, CO2, etc.) so as to further
tension the side
wall of the body lumen and/or body cavity, whereby to better present the side
wall
of the body lumen and/or body cavity for viewing through endoscope 10 and
stabilize the side wall so as to facilitate more precise therapeutic
interventions.
If desired, fore balloon 35 can be retracted toward aft balloon 20 (i.e., by
pulling push tube handle 37 proximally), while remaining inflated (and hence
maintaining a grip on the side wall of the body lumen and/or body cavity), so
as
to move the visible mucosa and further improve visualization and access (see
Fig.
22), e.g., so as to position a particular target area on the side wall of the
body
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lumen and/or body cavity at a convenient angle relative to the endoscope and
endoscopic tools.
Alternatively, if desired, once aft balloon 35 has been inflated, push tubes
30 may be advanced distally a portion ¨ but only a portion - of their full
distal
5 stroke, then fore balloon 35 may be inflated so as to grip the side wall
of the body
lumen and/or body cavity, and then push tubes 30 may be further advanced
distally. This action will cause flexible push tubes 30 to bow outwardly (see
Figs.
22A-22D), contacting the side wall of the body lumen and/or body cavity and
pushing the side wall of the body lumen and/or body cavity outwardly, e.g., in
a
1 0 "tenting" fashion, whereby to further enhance visualization of the side
wall of the
body lumen and/or body cavity by endoscope 10.
If desired, instruments 190 (Fig. 23) may be advanced through working
channels of endoscope 10 so as to biopsy and/or treat pathologic conditions
(e.g.,
excise pathological anatomy). It will be appreciated that such instruments
will
15 extend through the distal end of the endoscope, which is effectively
stabilized
relative to the anatomy via aft balloon 20, so that the working ends of
instruments
190 will also be highly stabilized relative to the anatomy. This is a
significant
advantage over the prior art practice of advancing instruments out of the non-
stabilized end of an endo scope. Preferably instruments 190 include
articulating
2 0 instruments having a full range of motion, whereby to better access
target
anatomy.
Furthermore, if bleeding were to obscure a tissue site, or if bleeding were
to occur and the surgeon is unable to identify the source of the bleeding, the
isolated therapeutic zone permits rapid flushing of the anatomic segment in
which
25 the therapeutic zone lies (e.g., with a liquid such as saline) with
rapid subsequent
removal of the flushing liquid (see Figs. 24-26).
Also, if desired, fore balloon 35 can be directed with high precision to a
bleeding site, whereupon fore balloon 35 may be used (e.g., inflated) to apply
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local pressure to the bleeding site in order to enhance bleeding control (see
Fig.
27). This can be done under the visualization provided by endoscope 10.
If it is desired to reposition endoscope 10 within the anatomy with
minimal interference from apparatus 5, fore balloon 35 is returned to its
torus
configuration (i.e., partially deflated), the fore balloon is retracted
proximally and
"re-docked" on the distal end of endoscope 10, aft balloon 20 is deflated, and
then
endoscope 10 (with apparatus 5 carried thereon) is repositioned within the
anatomy. Note that where fore balloon 35 is to be re-docked on the distal end
of
endoscope 10, fore balloon 35 is preferably only partially deflated until fore
balloon 35 is re-docked on the distal end of the endoscope, since partial
inflation
of fore balloon 35 can leave fore balloon 35 with enough "body" to facilitate
the
re-docking process. Thereafter, fore balloon 35 may be fully deflated if
desired,
e.g., so as to positively grip the distal end of endoscope 10.
Alternatively, if desired, fore balloon 35 may be used as a drag brake to
control retrograde motion of the endoscope. More particularly, in this form of
the
invention, endoscope 10 and apparatus 5 are first advanced as a unit into the
body
lumen and/or body cavity until the tip of the endo scope is at the proper
location.
Next, aft balloon 20 is inflated, push tubes 30 are advanced distally, and
then fore
balloon 35 is inflated (Fig. 28). Visualization and, optionally, therapeutic
2 0 treatment may then be effected at that location. When the apparatus is
to be
moved retrograde, aft balloon 20 is deflated, fore balloon 35 is partially
deflated,
and then the endoscope is withdrawn proximally, dragging the semi-inflated
fore
balloon 35 along the body lumen and/or body cavity (Fig. 29), with fore
balloon
35 acting as something of a brake as the endoscope is pulled proximally,
thereby
enabling more controlled retrograde movement of the endoscope and hence better
visualization of the anatomy. If at some point it is desired, aft balloon 20
and fore
balloon 35 can be re-inflated, as shown in Fig. 30, with or without
introduction of
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a fluid into the "isolated therapeutic zone" established between the two
balloons,
so as to stabilize, straighten, expand and/or flatten the anatomy.
It is also possible to use aft balloon 20 as a brake when withdrawing the
endoscope (and hence apparatus 5) from the anatomy, either alone or in
combination with the aforementioned braking action from fore balloon 35.
At the conclusion of the procedure, endoscope 10 and apparatus 5 are
withdrawn from the anatomy. Preferably this is done by deflating (or partially
deflating) fore balloon 35, retracting push tubes 30 so that fore balloon 35
is "re-
docked" onto the distal end of endoscope 10, fully deflating fore balloon 35
so
1 0 that it grips the distal end of the endoscope, deflating aft balloon 20
(if it is not yet
deflated), and then withdrawing endoscope 10 and apparatus 5 as a unit from
the
anatomy.
It should be appreciated that apparatus 5 may also be used advantageously
in various ways other than those disclosed above. By way of example but not
limitation, when endoscope 10 (and apparatus 5) is to be advanced within the
colon, it may be desirable to first project fore balloon 35 distally under
visual
guidance of the endoscope so that fore balloon 35 leads the distal end of the
endoscope. As a result, when the endoscope is advanced distally, with fore
balloon 35 being deflated (or partially deflated), the fore balloon and
flexible push
2 0 tubes 30 may act as an atraumatic lead (guiding structure) for the
endoscope as
the endoscope advances through the colon. Significantly, inasmuch as the
distal
ends of push tubes 30 are preferably highly flexible, as the advancing fore
balloon
35 encounters the colon wall (e.g., at a turn of the colon), the flexible push
tubes
can deflect so that the fore balloon tracks the path of the colon, thereby
aiding
atraumatic advancement of the endoscope along the colon. It should also be
appreciated that apparatus 5 may also be used advantageously in other ways to
facilitate further examinations of the luminal surface otherwise difficult to
be
performed currently. Such an example is endoscopic ultrasound examination of
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the lumen which would be facilitated by the fluid-filled inflated fore balloon
and
ultrasound probe examination.
Additional Constructions
If desired, apparatus 5 may be constructed so that push tubes 30 may be
advanced or retracted independently of one another, as well as in conjunction
with
one another ¨ such independent advancement or retraction of push tubes 30 can
aid in steering the partially- or fully-deflated fore balloon 35 through the
body
lumen and/or body cavity, whereby to facilitate advancement or retraction of
endoscope 10 through the body lumen and/or body cavity, and/or such
independent advancement or retraction of push tubes 30 can facilitate applying
a
"turning force" to the anatomy with an inflated fore balloon 35, whereby to
better
present the anatomy for visualization and/or treatment.
By way of example but not limitation, in this form of the invention, and
looking now at Fig. 30A, push tubes 30 are each independently slidably mounted
to push tube handle 37 so that push tubes 30 can move independently of push
tube
handle 37 and each other. Stops 191 limit distal movement of push tubes 30
relative to push tube handle 37 so that a push tube cannot be moved completely
out of push tube handle 37. As a result of this construction, when fore
balloon 35
2 0 is to be moved distally, push tubes 30 are moved distally, either
together or
independently of one another. And when fore balloon 35 is to be moved
proximally, push tubes 30 are moved proximally, either together or
independently
of one another. At any point in a procedure, push tubes 30 can be moved
independently of one another so as to "turn" the fore balloon, e.g., such as
when
fore balloon 35 is inflated and engaging the anatomy, whereby to apply a
"turning
force" to the anatomy, or where fore balloon 35 is partially inflated and is
being
used as an atraumatic tip for the advancing assembly, whereby to help "steer"
the
assembly through the anatomy. Note that it may be desirable to provide a
limiting
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mechanism to limit the extent to which push rods 30 may be moved,
longitudinally, independently of one another, in order to prevent excessive
turning
of fore balloon 35, and/or push rod cross-over, and/or push rod entanglement,
and/or push rod misalignment, etc. Note also that push tubes 30 may be held in
a
particular disposition by mounting push tubes 30 in the aforementioned clamp
53
(Figs. 12 and 15).
It should also be appreciated that it is possible to modify the construction
of sleeve 15 so as to support instruments (or hollow instrument guide tubes)
external to endoscope 10. More particularly, looking again at Figs. 5 and 6,
it will
1 0 be seen that in the construction shown in Figs. 5 and 6, sleeve 15
comprises a
lumen 47 for receiving inflation/deflation tube 45 for inflating/deflating aft
balloon 20, and a pair of lumens 52 for receiving support tubes 50 which
receive
push tubes 30 for manipulating and inflating/deflating fore balloon 35.
However,
if desired, sleeve 15 may include additional lumens for supporting instruments
(or
hollow instrument guide tubes) external to endoscope 10.
More particularly, and looking now at Fig. 31, there is shown an end view
of another form of sleeve 15 which includes a plurality of lumens 195 for
slidably
receiving instruments 190 therein. Note that, when inflated, aft balloon 20
provides a secure platform for maintaining endoscope 10 and sleeve 15 within a
body lumen or body cavity, with endoscope 10 and sleeve 15 centered within the
body lumen or body cavity. As a result, the distal ends of lumens 195 of
sleeve
15 will also be securely maintained within the body lumen or body cavity so as
to
provide a secure support for instruments advanced through lumens 195 of sleeve
15.
The proximal ends of lumens 195 may extend to, and through, base 25, in
which case instruments may be inserted into lumens 195 at base 25, or the
proximal ends of lumens 195 may terminate proximal to base 25 (but still
outside
the body of the patient), in which case instruments may be inserted into
lumens
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195 intermediate sleeve 15. By way of example but not limitation, where
endoscope 10 is 180 cm in length and instruments 190 are 60 cm in length, it
can
be advantageous to insert instruments 190 into lumens 195 at a point closer to
balloons 20, 35 (rather than at base 25). Note that in Fig. 31, the lumen 47
for
5 receiving inflation/deflation tube 45 and inflation/deflation tube 45
for
inflating/deflating aft balloon 20 are not visible, since the view is distal-
facing
and is taken at a location distal to where lumen 47 and inflation/deflation
tube 45
terminate on sleeve 15.
Figs. 32-35 show various instruments 190 extending out of lumens 195.
1 0 Note that instruments 190 preferably comprise articulating instruments,
e.g.,
graspers 190A in Figs 32-35, a cauterizing device 190B in Figs. 32-33,
scissors
190C in Figs. 34 and 35, and a suction device 190D in Figs. 32-35.
It should be appreciated that where sleeve 15 comprises its central
passageway for receiving endoscope 10, lumen 47 for receiving
inflation/deflation
15 tube 45, lumens 52 for receiving support tubes 50 which receive push
tubes 30,
and/or lumens 195 for slidably receiving instruments 190 therein, sleeve 15 is
preferably formed by an extrusion process.
In one preferred form of the invention, lumen 47 for receiving
inflation/deflation tube 45, lumens 52 for receiving support tubes 50 which
2 0 receive push tubes 30, and/or lumens 195 for slidably receiving
instruments 190
may have a fixed configuration (i.e., a fixed diameter), so that sleeve 15 has
a
fixed outer profile.
In another preferred form of the invention, lumen 47 for receiving
inflation/deflation tube 45, lumens 52 for receiving support tubes 50 which
25 receive push tubes 30, and/or lumens 195 for slidably receiving
instruments 190
may have an expandable configuration (i.e., they may have a minimal profile
when empty and expand diametrically as needed when filled), so that the
overall
profile of sleeve 15 is minimized.
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It should also be appreciated that where sleeve 15 comprises a plurality of
lumens 195 for slidably receiving instruments 190 therein, it can be desirable
to
provide greater structural integrity to the distal ends of lumens 195 so as to
provide improved support for the instruments 190 received within lumens 195.
To this end, a support ring may be provided at the distal end of sleeve 15,
wherein
the support ring provides openings for the passage of push tubes 30 and
openings
for the passage of instruments 190. Note that the openings in such a support
ring
for the passage of instruments 190 preferably make a close fit with the
instruments so as to provide excellent instrument support at the distal end of
sleeve 15.
Alternatively and/or additionally, lumens 195 may accommodate hollow
instrument guide tubes which themselves accommodate instruments therein. Such
hollow instrument guide tubes can provide greater structural integrity to the
distal
ends of lumens 195 so as to provide improved support for the instruments 190
received within lumens 195. And such hollow instrument guide tubes may be of
fixed geometry or of bendable or articulating geometry. See, for example, Fig.
36, which shows hollow instrument guide tubes 200 extending out of lumens 195
and receiving instruments 190 therein. Note that hollow instrument guide tubes
200 may be independently movable relative to one another (and independently
2 0 movable relative to sleeve 15). Note also that instruments 190
preferably make a
close fit with hollow instrument guide tubes 200 so as to provide excellent
instrument support at the distal end of sleeve 15.
It should also be appreciated that, if desired, the two push tubes 30 may be
replaced by a single push tube 30 or by more than two push tubes 30, e.g., by
three push tubes 30. It will be appreciated that, where a plurality of push
tubes 30
are provided, it will generally be desirable to equally-circumferentially-
space the
push tubes from one another, e.g., where two push tubes 30 are provided, it is
generally desirable that the two push tubes 30 be spaced 180 degrees apart,
where
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three push tubes 30 are provided, it is generally desirable that the push
tubes be
spaced 120 degrees apart, etc.
Tissue Retraction And Tissue Retrieval
Tissue Retraction
In some circumstances it may be necessary or desirable to dissect tissue
within a body lumen or body cavity. By way of example but not limitation,
Endoscopic Submucosal Dissection (ESD) is an endoscopic dissection
1 0 procedure for removing intestinal lesions in one piece, even if the
intestinal
lesions are quite large. With ESD, the lesions are dissected directly along
the
submucosal layer of the intestine using a cutting tool (e.g., an
electrocautery knife
equipped with an energy source) passed through the endoscope, resulting in
safer
en-bloc dissection of even large lesions.
A number of challenges exist with conventional ESD. First, this technique
involves pushing the endoscope tip into the tissue, using a clear plastic cap
placed
over the tip of the endoscope, which stretches the submucosal fibers and aids
in
tissue dissection. However, this technique partially obstructs the surgeon's
view.
Second, fluid, debris, and smoke typically accumulate within the clear plastic
cap
placed over the tip of the endoscope, further obscuring the surgeon's view.
In addition to the foregoing, ESD procedures are generally time-
consuming and frequently take several hours. The majority of this time is
frequently spent dissecting the lesion along the submucosal layer of the
intestine.
Similar problems can occur with other endoluminal tissue dissection
procedures.
An endoscopic tissue retraction system compatible with ESD procedures
and other endoluminal tissue dissection procedures would provide the surgeon
with better visualization of the surgical field and speed up the dissection
process.
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Tissue Retrieval
In addition to the foregoing, following dissection of a lesion from the
submucosal layer of the intestine, or following dissection of other tissue
during an
endoluminal tissue dissection procedure, the lesion (or other dissected
tissue) can
be difficult to retrieve due to the technical challenges of (i) locating the
dissected
lesion (or other dissected tissue) within the intestine, and (ii) grasping the
dissected tissue (or other dissected tissue) with a retrieval tool. In
addition,
dissected lesions (or other dissected tissue) which comprise early cancers may
1 0 contaminate (e.g., potentially seed with cancerous cells) disease-free
areas of the
intestine if they migrate within the intestine.
An endoscopic tissue retrieval system compatible with ESD procedures
and other endoluminal tissue dissection procedures would provide the surgeon
with better control and securement of the dissected lesion within the
intestine.
Endoscopic Tissue Retraction System
To this end, in one preferred form of the invention, and looking now at
Figs. 37-42, there is shown novel apparatus 5 being used in combination with
an
endoscopic tissue retraction system 300 to provide the surgeon with better
2 0 visualization of the surgical field and to speed up the dissection
process, e.g.,
during an ESD procedure. In this form of the invention, a connector 305 is
secured to (i) fore balloon 35 (or to a push tube 30) and (ii) a lesion 315.
This
may be done by clipping connector 305 to fore balloon 35 (or to a push tube
30)
with a surgical clip 320, and by clipping connector 305 to lesion 315 with
another
surgical clip 320. It will be appreciated that connector 305 and surgical
clips 320
may be delivered to the surgical site through a working channel of endoscope
10
(or through an instrument lumen 95 of apparatus 5). With connector 305 secured
to both fore balloon 35 (or to a push tube 30) and to lesion 315, fore balloon
35
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may be advanced distally so as to tension connector 305, whereby to urge
(i.e., to
apply a force to) lesion 315 in a distal direction. A cutting tool 325 may
then be
advanced out the distal end of endoscope 10 (or through an instrument lumen 95
of apparatus 5) and used to dissect lesion 315 along the submucosal layer 330
of
the intestine 335. It will be appreciated that after lesion 315 has been cut
free
from the submucosal layer of the intestine, lesion 315 will remain tethered to
fore
balloon 35 by means of connector 305 and surgical clips 320.
In one preferred form of the invention, connector 305 comprises a loop of
material (e.g., a loop made out of an extruded filament, a loop made out of a
1 0 braid, etc.). Alternatively, connector 305 may comprise a single strand
of
material (e.g., a single strand made out of an extruded filament, a single
strand
made out of a braid, etc.).
In one preferred form of the invention, connector 305 is formed out of an
elastomeric material (e.g., an elastomeric filament or an elastomeric braid,
etc.) so
that connector 305 automatically takes up any slack in connector 305 as lesion
315 is cut away from submucosal layer 330 of intestine 335. In another form of
the invention, connector 305 may be formed out of an inelastic flexible
material.
In still another form of the invention, connector 305 may be formed out of an
inelastic rigid material.
2 0 In one form of the invention, fore balloon 35 is advanced distally
so as to
tension connector 305, whereby to urge (i.e., to apply a force to) lesion 315
in a
distal direction. In an alternative form of the invention, and looking now at
Figs.
43-45, where connector 305 comprises an elastomeric material, connector 305
may be secured to one or the other of fore balloon 35 and lesion 315,
stretched,
secured to the other of fore balloon 35 and lesion 315, and then released,
whereby
to urge (i.e., to apply a force to) lesion 315 in a distal direction without
requiring
any movement of fore balloon 35 in a distal direction. Alternatively,
connector
305 may be stretched, secured (in its stretched condition) to fore balloon 35
and to
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lesion 315, and then released, whereby to urge (i.e., to apply a force to)
lesion 315
in a distal direction without requiring any movement of fore balloon 35 in a
distal
direction.
In another form of the invention, and looking now at Fig. 46, connector
5 305 may comprise a loop 340 having a variable length, e.g., loop 340 may
comprise a slipknot 345 having a tensioning end 350. In this form of the
invention, with connector 305 in a slack condition, connector 305 is clipped
to
fore balloon 35 (or to a push tube 30) with a surgical clip 320, and connector
305
is clipped to lesion 315 with another surgical clip 320. Then connector 305 is
10 tensioned (e.g., by pulling on tensioning end 350 of slipknot 345 using
a tool
advanced through a working channel of endoscope 10 or through an instrument
lumen 95 of apparatus 5), whereby to urge (i.e., to apply a force to) lesion
315 in
a distal direction. Then cutting tool 325 may be advanced out the distal end
of
endoscope 10 (or through an instrument lumen 95 of apparatus 5) and used to
15 dissect lesion 315 along submucosal layer 330 of intestine 335. Again,
it will be
appreciated that after lesion 315 has been dissected away from the submucosal
layer of the intestine, lesion 315 will remain tethered to fore balloon 35 by
means
of connector 305 and surgical clips 320.
In another form of the invention, connector 305 may comprise a loop 340
20 having a variable length, but with slipknot 345 and tensioning end 350
being
replaced by a length adjustment clip 355 and one or more tensioning ends 360.
See Fig. 47. In this form of the invention, loop 340 is tensioned by pulling
on the
one or more tensioning ends 360 using a tool advanced through a working
channel of endoscope 10 (or through an instrument lumen 95 of apparatus 5).
25 In some cases, and looking now at Fig. 48, it can be advantageous
to
provide connector 305 with a substantially rigid ring 365 at its proximal
(i.e.,
lesion-side) end. By way of example but not limitation, where connector 305 is
in
the form of a loop, the loop of connector 305 may pass through the center of
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substantially rigid ring 365. Substantially rigid ring 365 can facilitate
securing
connector 305 to lesion 315, e.g., by making it easier to clip connector 305
to
lesion 315 using a surgical clip 320.
In some cases it can be desirable to use multiple connectors 305 to connect
lesion 315 to fore balloon 35. This can allow lesion 315 to be tensioned
distally
with multiple direction vectors and with multiple attachment points, which can
assist in dissection of lesion 315 from submucosal layer 330 of intestine 335.
See
Fig. 49.
Alternatively, and looking now at Fig. 50, where connector 305 is in the
1 0 form of a loop, multiple substantially rigid rings 365 may be mounted
to a single
connector 305 and the multiple substantially rigid rings 365 may be secured to
different locations on lesion 315, whereby to allow lesion 315 to be tensioned
distally with multiple direction vectors and with multiple attachment points.
Or
where connector 305 is in the form of a loop, different segments of the loop
may
be secured to different locations on lesion 315 using a plurality of surgical
clips
320, whereby to allow lesion 315 to be tensioned distally with multiple
direction
vectors and with multiple attachment points.
In one form of the invention, connectors 305 are attached to fore balloon
35 (or to a push tube 30) in situ using surgical clips 320. However, if
desired,
2 0 connectors 305 may be pre-attached to fore balloon 35 (or to one or
more of push
tubes 30) at the time of manufacture (or at some other time prior to insertion
of
fore balloon 35 into the body). By way of example but not limitation, and
looking
now at Figs. 51 and 52, connectors 305 may be pre-attached to fore balloon 35
using eyelets or grommet-lined eyelets 370.
It should also be appreciated that in some circumstances it may be possible
to secure fore balloon 35 (or one of push tubes 30) directly to lesion 315
without
using a connector 305. By way of example but not limitation, one or more
surgical clips 320 may be used to secure fore balloon 35 (or one of push tubes
30)
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directly to lesion 315. See, for example, Fig. 52A which shows a surgical clip
320 securing fore balloon 35 directly to lesion 315 without using a connector
305.
See also, for example, Fig. 52B which shows a surgical clip 320 securing a
push
tube 30 directly to lesion 315 without using a connector 305.
Once lesion 315 has been dissected from submucosal layer 330 of
intestine 335 (or other tissue has been dissected from its site within a body
lumen), the dissected tissue must generally be removed from the body of the
patient. Inasmuch as the dissected tissue is secured to fore balloon 35 (or to
a
push rod 30) by means of one or more connectors 305 and/or surgical clips 320,
the dissected tissue can be removed from the body by simply removing novel
apparatus 5 from the body of the patient, which will withdraw the dissected
tissue
from the body of the patient as fore balloon 35 is withdrawn from the body of
the
patient. However, this approach runs the risk of the dissected tissue tearing
free
from fore balloon 35 (or a push tube 30), e.g., by failure of the surgical
clip
mounted to the dissected tissue, or by failure of the surgical clip mounted to
the
fore balloon (or to a push tube), etc. Furthermore, this approach essentially
drags
the exposed dissected tissue along the length of the intestine (or other body
lumen) as novel apparatus 5 is withdrawn from the body of the patient. This
can
present risks to the patient, e.g., where the dissected tissue comprises early
2 0 cancers which may contaminate (e.g., potentially seed with cancerous
cells)
disease-free areas of the intestine (or other body lumen).
Endoscopic Tissue Retrieval
To this end, and looking now at Figs. 53-60, fore balloon 35 may include a
flap 375 disposed within the central bore 380 of fore balloon 35. Flap 375 is
constructed so that (i) when fore balloon 35 is docked over endoscope 10, flap
375 is captured between endoscope 10 and fore balloon 35; (ii) when fore
balloon
is undocked from endoscope 10, and then projected distally away from
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endoscope 10, and then fully inflated, flap 375 is captured within the closed-
down
central bore 380 of fore balloon 35 (Figs. 53 and 54); and (iii) when fore
balloon
35 is projected distally away from endoscope 10, and then partially deflated,
so
that central bore 380 of fore balloon 35 is re-opened, exposing flap 375
(Figs. 55
and 56), flap 375 may be "pulled down" across central bore 380 of fore balloon
35 (e.g., with a tool advanced through endoscope 10 or an instrument lumen 95
of
apparatus 5) so as to form, in conjunction with the surrounding portions of
fore
balloon 35 defining central bore 380, a concave pouch 385 within central bore
380 of fore balloon 35 (Figs. 57 and 58). This concave pouch 385 is configured
1 0 to receive dissected tissue (Figs. 59 and 60).
Thus, in this form of the invention, after dissection of lesion 315 from
submucosal layer 330 of intestine 335 (or after dissection of other tissue
from its
site within a body lumen), the dissected tissue is manipulated into concave
pouch
385 (e.g., using tools advanced through working channels of endoscope 10 or
through instrument lumens 95 of apparatus 5) and then the dissected tissue can
be
easily and safely removed from the body by simply removing novel apparatus 5
from the body of the patient, which will withdraw the dissected tissue from
the
body of the patient as fore balloon 35 is withdrawn from the body of the
patient.
Note that this may be done while the dissected tissue is still connected to
fore
2 0 balloon 35 (or to a push tube 30) via connector(s) 305 and/or surgical
clip(s) 320.
Note also that this approach effectively eliminates the risk of the dissected
tissue
tearing free from fore balloon 35 (or a push tube 30), e.g., by failure of the
surgical clip mounted to the dissected tissue, or by failure of the surgical
clip
mounted to the fore balloon (or to a push tube), etc., and reduces the risk of
early
cancer lesions contaminating (e.g., potentially seeding with cancerous cells)
disease-free areas of the intestine (or other body lumen) since the dissected
tissue
is shielded within concave pouch 385 as the dissected tissue is withdrawn from
the body of the patient.
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Applications
Thus it will be seen that the present invention comprises the provision and
use of novel apparatus for manipulating the side wall of a body lumen and/or
body cavity so as to better present the side wall tissue (including
visualization of
areas initially hidden or outside the field of view) for examination and/or
treatment during an endoscopic procedure, e.g., to straighten bends, "iron
out"
inner luminal surface folds and create a substantially static or stable side
wall of
the body lumen and/or body cavity which enables more precise visual
1 0 examination (including visualization of areas initially hidden or
outside the field
of view) and/or therapeutic intervention. By way of example but not
limitation,
the novel apparatus can be used to stabilize, straighten, expand and/or
flatten
bends and/or curves and/or folds in the side wall of the intestine so as to
better
present the side wall tissue (including visualization of areas initially
hidden or
outside the field of view) for examination and/or treatment during an
endoscopic
procedure.
The present invention also comprises the provision and use of novel
apparatus capable of steadying and/or stabilizing the distal tips and/or
working
ends of instruments (e.g., endoscopes, articulating and/or non-articulating
devices
2 0 such as graspers, cutters or dissectors, cauterizing tools, ultrasound
probes, etc.)
inserted into a body lumen and/or body cavity during an endoscopic procedure
with respect to the side wall of the body lumen and/or body cavity, whereby to
facilitate the precision use of those instruments.
By way of example but not limitation, the present apparatus can provide a
stable platform (i.e., a stable endoscope, stable therapeutic tools and a
stable colon
wall, all stable with respect to one another) for the performance of numerous
minimally-invasive procedures within a body lumen and/or body cavity,
including
the stabilization of an endoscope and/or other surgical instruments (e.g.,
graspers,
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cutters or dissectors, cauterizing tools, ultrasound probes, etc.) within the
body
lumen and/or body cavity, e.g., during a lesion biopsy and/or lesion removal
procedure, an organ resection procedure, endoscopic submucosal dissection
(ESD), endoscopic mucosal resection (EMR), etc., while at the same time
5 stabilizing the colon (including decreasing deformation of the colon
wall) so as to
enable more precise visualization, intervention and/or surgery.
Significantly, the present invention provides novel apparatus capable of
steadying and/or stabilizing the distal tips and/or working ends of endoscopes
(and hence also steadying and/or stabilizing the distal tips and/or working
ends of
10 other instruments inserted through the working channels of those
endoscopes,
such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes,
etc.)
with respect to the side wall of the body lumen and/or body cavity, and
stabilizing
the side wall of the body lumen and/or body cavity relative to these
instruments.
And the present invention provides novel apparatus capable of steadying
15 and/or stabilizing the distal tips and/or working ends of instruments
(such as
graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.)
advanced
to the surgical site by means other than through the working channels of
endoscopes.
The novel apparatus of the present invention can be used in substantially
2 0 any endoscopic procedure to facilitate the alignment and presentation
of tissue
during an endoscopic procedure and/or to stabilize the working end of an
endoscope (and/or other instruments advanced through the endoscope) relative
to
tissue or to assist in the advancement of the endoscope during such a
procedure.
The present invention is believed to have widest applications with respect
25 to the gastrointestinal (GI) tract (e.g., large and small intestines,
esophagus,
stomach, etc.), which is generally characterized by frequent turns and which
has a
side wall characterized by numerous folds and disease processes located on and
between these folds. However, the methods and apparatus of the present
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invention may also be used inside other body lumens (e.g., blood vessels,
lymphatic vessels, the urinary tract, fallopian tubes, bronchi, bile ducts,
etc.)
and/or inside other body cavities (e.g., the head, chest, abdomen, nasal
sinuses,
bladder, cavities within organs, etc.).
Modifications
While the present invention has been described in terms of certain
exemplary preferred embodiments, it will be readily understood and appreciated
by those skilled in the art that it is not so limited, and that many
additions,
1 0 deletions and modifications may be made to the preferred embodiments
discussed
above while remaining within the scope of the present invention.
