U.S. patent application number 17/392897 was filed with the patent office on 2022-06-09 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.
The applicant listed for this patent is Lumendi Ltd.. Invention is credited to Anthony Assal, Audrey Bell, Phal kun Chan, Brian David Chouinard, John Frederick Cornhill, Matthew DeNardo, Christopher Dillon, Stephen Evans, Alan Fortunate, Gabriel Greeley, Jeffrey Milsom, Tuan Anh Nguyen, William Rebh, Timothy Robinson, Rahul Sathe, Sameer Sharma, Jeremy Van Hill, Ashley Whitney, Richard Yazbeck.
Application Number | 20220175221 17/392897 |
Document ID | / |
Family ID | |
Filed Date | 2022-06-09 |
United States Patent
Application |
20220175221 |
Kind Code |
A1 |
Cornhill; John Frederick ;
et al. |
June 9, 2022 |
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
Abstract
Apparatus comprising: a sleeve adapted to be slid over the
exterior of an endoscope; an aft balloon secured to the sleeve; an
inflation/deflation tube carried by the sleeve and in fluid
communication with the interior of the aft balloon; a pair of
hollow push tubes slidably mounted to the sleeve, the pair of
hollow push tubes being connected to one another at their distal
ends with a raised push tube bridge, the raised push tube bridge
being configured to nest an endoscope therein; and a fore balloon
secured to the distal ends of the pair of hollow push tubes, the
interior of the fore balloon being in fluid communication with the
interiors of the pair of hollow push tubes, wherein the fore
balloon is capable of assuming a deflated condition and an inflated
condition, and further wherein (i) when the fore balloon is in its
deflated condition, an axial opening extends therethrough, the
axial opening being sized to receive the endoscope therein, and
(ii) when the fore balloon is in its inflated condition, the axial
opening is closed down.
Inventors: |
Cornhill; John Frederick;
(New York, NY) ; Milsom; Jeffrey; (New York,
NY) ; Sharma; Sameer; (New York, NY) ; Nguyen;
Tuan Anh; (Woburn, MA) ; Dillon; Christopher;
(Underhill, VT) ; Greeley; Gabriel; (Somerville,
MA) ; Sathe; Rahul; (Needham, MA) ; DeNardo;
Matthew; (Melrose, MA) ; Whitney; Ashley;
(Boston, MA) ; Van Hill; Jeremy; (Somerville,
MA) ; Assal; Anthony; (Jamaica, NY) ; Evans;
Stephen; (Westford, MA) ; Robinson; Timothy;
(Sandown, NH) ; Fortunate; Alan; (Watertown,
MA) ; Bell; Audrey; (Alton, MA) ; Yazbeck;
Richard; (Norwell, MA) ; Chouinard; Brian David;
(Lynn, MA) ; Chan; Phal kun; (Brighton, MA)
; Rebh; William; (Shrewsbury, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lumendi Ltd. |
Buckinghamshire |
|
GB |
|
|
Appl. No.: |
17/392897 |
Filed: |
August 3, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16215843 |
Dec 11, 2018 |
11076743 |
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17392897 |
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15172385 |
Jun 3, 2016 |
10149601 |
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16215843 |
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14619845 |
Feb 11, 2015 |
9986893 |
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15172385 |
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14540355 |
Nov 13, 2014 |
9924853 |
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14619845 |
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12969059 |
Dec 15, 2010 |
8979884 |
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14540355 |
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61284215 |
Dec 15, 2009 |
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61938446 |
Feb 11, 2014 |
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62170476 |
Jun 3, 2015 |
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62170497 |
Jun 3, 2015 |
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62244008 |
Oct 20, 2015 |
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62244214 |
Oct 21, 2015 |
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62305773 |
Mar 9, 2016 |
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62305797 |
Mar 9, 2016 |
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62305804 |
Mar 9, 2016 |
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International
Class: |
A61B 1/00 20060101
A61B001/00; A61B 1/31 20060101 A61B001/31; A61M 25/10 20060101
A61M025/10 |
Claims
1.-40. (canceled)
41. Apparatus comprising: a sleeve adapted to be slid over an
exterior of an endoscope, the sleeve comprising a proximal end and
a distal end; a pair of push tubes slidably mounted to the sleeve,
the pair of push tubes each comprising a proximal end and a distal
end; a fore balloon secured to the distal ends of the pair of push
tubes, wherein the fore balloon is capable of assuming a deflated
condition and an inflated condition; and a push tube handle secured
to the proximal ends of the pair of push tubes for moving the pair
of push tubes relative to the sleeve.
42. Apparatus according to claim 41 further comprising a base
secured to the sleeve at the proximal end of the sleeve, wherein
the base is configured to support and guide the push tube handle as
the push tube handle moves the pair of push tubes relative to the
sleeve.
43. Apparatus according to claim 42 wherein the base comprises an
extension having a center slot and a pair of side slots, and
further wherein the extension comprises at least one fitting for
inflating/deflating the fore balloon.
44. Apparatus according to claim 43 wherein the push tube handle
comprises a C-shaped body having a center locking element and a
pair of finger grips mounted thereto such that the push tube handle
can be (i) locked in position relative to the extension by the
center locking element, whereby to lock the fore balloon in
position, and (ii) moved distally or proximally relative to the
extension, whereby to move the fore balloon distally or
proximally.
45. Apparatus according to claim 44 wherein the center locking
element comprises a screw shaft and a screw knob, and further
wherein the push tube handle is mounted within the extension of the
base so that the screw shaft is slidably received in the center
slot of the extension and so that the finger grips are slidably
received in the pair of side slots in the extension.
46. Apparatus according to claim 45 wherein the push tube handle is
locked to the extension by turning the screw knob until the screw
knob engages an outer surface of the extension.
47. Apparatus according to claim 45 wherein torsion can be applied
to the fore balloon by applying torsion to the finger grips.
48. Apparatus according to claim 41 further comprising an aft
balloon secured to the sleeve.
49. Apparatus according to claim 41 wherein the endoscope comprises
a proximal end and a distal end, wherein the proximal end of the
endoscope comprises a handle, and further wherein the sleeve is
sized 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.
50. Apparatus according to claim 41 further comprising an
inflation/deflation tube formed integral with the sleeve.
51. Apparatus according to claim 41 wherein the sleeve comprises a
pair of passageways for receiving the pair of push tubes.
52. Apparatus according to claim 51 wherein the pair of passageways
are formed integral with the sleeve.
53. Apparatus according to claim 51 wherein each of the pair of
passageways receives a support tube which receives a push tube.
54. Apparatus according to claim 41 wherein the sleeve comprises a
lumen for receiving an instrument.
55. Apparatus according to claim 54 wherein the lumen is formed
integral with the sleeve.
56. Apparatus according to claim 48 wherein the aft balloon
comprises a body having a proximal opening and a distal opening, a
distal extension extending distally from the body, a proximal
extension extending proximally from the body, and further wherein
the aft balloon is formed by everting the distal extension into an
interior of the body and into an interior of the proximal
extension.
57. Apparatus according to claim 48 wherein at least one of the
sleeve, the aft balloon, the pair of push tubes and the fore
balloon comprises a visualizable marker.
58. Apparatus according to claim 41 further comprising an inflation
mechanism for selectively inflating/deflating the fore balloon.
59. Apparatus according to claim 41 wherein the pair of push tubes
are connected to one another at their distal ends by a raised push
tube bridge, and further wherein the raised push tube bridge is
configured to nest an endoscope therein.
60. Apparatus according to claim 59 wherein the raised push tube
bridge is in the form of a ring.
Description
REFERENCE TO PENDING PRIOR PATENT APPLICATIONS
[0001] This patent application:
[0002] (1) is a continuation-in-part of pending prior U.S. patent
application Ser. No. 14/619,845, filed Feb. 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: [0003] (A) is a continuation-in-part of pending prior
U.S. patent application Ser. No. 14/540,355, filed Nov. 13, 2014 by
Cornell University and Jeffrey Milsom et al. for METHOD AND
APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR
FLATTENING 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 (Attorney's Docket No. CORN-17 CON), which patent
application: [0004] (i) is a continuation of prior U.S. patent
application Ser. No. 12/969,059, filed Dec. 15, 2010 by Jeffrey
Milsom et al. for METHOD AND APPARATUS FOR STABILIZING,
STRAIGHTENING, EXPANDING AND/OR FLATTENING 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 (Attorney's Docket No.
CORN-17), which patent application: [0005] (a) claims benefit of
prior U.S. Provisional Patent Application Ser. No. 61/284,215,
filed Dec. 15, 2009 by Jeffrey Milsom et al. for METHOD AND
APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR
FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO
PROVIDE INCREASED VISUALIZATION OF THE SIDE WALL OF THE BODY LUMEN
OR BODY CAVITY, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE
SAME (Attorney's Docket No. CORN-17 PROV); and [0006] (B) claims
benefit of prior U.S. Provisional Patent Application Ser. No.
61/938,446, filed Feb. 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 ACCESS TO THE
SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME
(Attorney's Docket No. CORN-34 PROV);
[0007] (2) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/170,476, filed Jun. 3, 2015 by Lumendi Ltd.
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. LUMENDI-1 PROV);
[0008] (3) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/170,497, filed Jun. 3, 2015 by Lumendi Ltd.
and Stephen Evans 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. LUMENDI-2 PROV);
[0009] (4) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/244,008, filed Oct. 20, 2015 by Lumendi
Ltd. and Alan Fortunate 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. LUMENDI-3 PROV);
[0010] (5) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/244,214, filed Oct. 21, 2015 by Lumendi
Ltd. and Audrey Bell 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. LUMENDI-4 PROV);
[0011] (6) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/305,773, filed Mar. 9, 2016 by Lumendi Ltd.
and Alan Fortunate 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, INCLUDING
VENTING OF BALLOONS THROUGH PACKAGING DESIGN (Attorney's Docket No.
LUMENDI-7 PROV);
[0012] (7) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/305,797, filed Mar. 9, 2016 by Lumendi Ltd.
and Brian David Chouinard 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,
INCLUDING IMPROVED AFT BALLOON THERMAL BONDING USING INSERT
MATERIAL (Attorney's Docket No. LUMENDI-9 PROV); and
[0013] (8) claims benefit of pending prior U.S. Provisional Patent
Application Ser. No. 62/305,804, filed Mar. 9, 2016 by Lumendi Ltd.
and Brian David Chouinard 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, INCLUDING IMPROVED FORE BALLOON CONSTRUCTION (Attorney's
Docket No. LUMENDI-10 PROV);
[0014] The twelve (12) above-identified patent applications are
hereby incorporated herein by reference.
FIELD OF THE INVENTION
[0015] 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
[0016] 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.
[0017] 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 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.
[0018] 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.
[0019] By way of example but not limitation, the intestine is an
elongated tubular organ having an inner lumen and is characterized
by frequent turns (i.e., the regional anatomic configuration of the
intestine), and comprises 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
endoscopes.
[0020] In addition to the foregoing, it has also been found that
some body lumens and/or body cavities can spasm and/or contract.
This spasming and/or contraction can occur spontaneously, but it is
particularly common when an endoscope or other instrument is
inserted into the body lumen and/or body 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
advancing and withdrawing the endoscope through the colon, the
endoscope may grip and/or otherwise gather the colon during
advancement and/or withdrawal and then suddenly slip and release
the colon. This gripping and then sudden release of the colon can
result in the endoscope moving quickly past significant lengths of
the colon, thereby making accurate examination of the colon
challenging.
[0021] 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 which may be initially hidden
from view or outside the field of view) for examination and/or
treatment during an endoscopic procedure.
[0022] 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, 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.
[0023] 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.).
[0024] 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 endoscopes.
[0025] 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 which may be initially hidden
from view or outside the field of view) and/or therapeutic
intervention.
SUMMARY OF THE INVENTION
[0026] 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 which may be initially hidden
from view or outside the field of view) for examination and/or
treatment during an endoscopic procedure.
[0027] 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.
[0028] 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
channels of those endoscopes, such as graspers, cutters or
dissectors, cauterizing tools, ultrasound probes, etc.).
[0029] 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.
[0030] 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 which may be
initially hidden from view or outside the field of view) and/or
therapeutic intervention.
[0031] In one preferred form of the present invention, there is
provided apparatus comprising: [0032] a sleeve adapted to be slid
over the exterior of an endoscope;
[0033] an aft balloon secured to the sleeve;
[0034] an inflation/deflation tube carried by the sleeve and in
fluid communication with the interior of the aft balloon;
[0035] a pair of hollow push tubes slidably mounted to the sleeve,
the pair of hollow push tubes being connected to one another at
their distal ends with a raised push tube bridge, the raised push
tube bridge being configured to nest an endo scope therein; and a
fore balloon secured to the distal ends of the pair of hollow push
tubes, the interior of the fore balloon being in fluid
communication with the interiors of the pair of hollow push tubes,
wherein the fore balloon is capable of assuming a deflated
condition and an inflated condition, and further wherein (i) when
the fore balloon is in its deflated condition, an axial opening
extends therethrough, the axial opening being sized to receive the
endoscope therein, and (ii) when the fore balloon is in its
inflated condition, the axial opening is closed down.
[0036] 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, the method comprising:
[0037] providing apparatus comprising: [0038] a sleeve adapted to
be slid over the exterior of an endoscope; [0039] an aft balloon
secured to the sleeve; [0040] an inflation/deflation tube carried
by the sleeve and in fluid communication with the interior of the
aft balloon; [0041] a pair of hollow push tubes slidably mounted to
the sleeve, the pair of hollow push tubes being connected to one
another at their distal ends with a raised push tube bridge, the
raised push tube bridge being configured to nest an endo scope
therein; and [0042] a fore balloon secured to the distal ends of
the pair of hollow push tubes, the interior of the fore balloon
being in fluid communication with the interiors of the pair of
hollow push tubes, wherein the fore balloon is capable of assuming
a deflated condition and an inflated condition, and further wherein
(i) when the fore balloon is in its deflated condition, an axial
opening extends therethrough, the axial opening being sized to
receive the endoscope therein, and (ii) when the fore balloon is in
its inflated condition, the axial opening is closed down;
[0043] positioning an endoscope in the sleeve so that the endoscope
nests in the push tube bridge;
[0044] positioning the apparatus in the body lumen and/or body
cavity;
[0045] inflating the aft balloon;
[0046] advancing the pair of push tubes distally;
[0047] inflating the fore balloon; and
[0048] performing the procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] 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 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:
[0050] 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 hollow push tubes slidably mounted to the sleeve, the pair of
hollow push tubes being connected to one another at their distal
ends with a raised push tube bridge, the raised push tube bridge
being configured to nest an endoscope therein, a fore balloon
mounted to the distal end of the hollow push tubes, and a push tube
handle mounted to the proximal ends of the hollow push tubes;
[0051] FIGS. 2-4 are schematic views showing various dispositions
of the fore balloon relative to the aft balloon;
[0052] FIG. 5 is a schematic view showing further details of the
distal end of the apparatus shown in FIG. 1;
[0053] FIG. 6 is a section view taken along line 6-6 of FIG. 5;
[0054] FIGS. 7 and 8 are schematic views showing a pair of hollow
push tubes, a raised push tube bridge, and the fore balloon;
[0055] FIGS. 9-11 are schematic views showing a pair of hollow push
tubes and a raised push tube bridge formed in accordance with the
present invention;
[0056] FIG. 12 is a schematic view showing another pair of hollow
push tubes and a raised push tube bridge formed in accordance with
the present invention;
[0057] FIG. 13 is a schematic view showing another pair of hollow
push tubes and a raised push tube bridge formed in accordance with
the present invention;
[0058] FIG. 14 is a schematic view showing another pair of hollow
push tubes and a raised push tube bridge formed in accordance with
the present invention;
[0059] FIGS. 15 and 16 are schematic views showing further details
of the fore balloon;
[0060] FIG. 17 is a schematic view showing the push tube
handle;
[0061] FIGS. 18 and 19 are schematic views showing construction
details of the fore balloon;
[0062] FIGS. 20-34 are schematic views showing another form of the
handle mechanism for the novel apparatus of the present
invention;
[0063] FIG. 35 is a schematic view showing one form of inflation
mechanism provided in accordance with the present invention;
[0064] FIG. 36 is a schematic view showing another form of
inflation mechanism provided in accordance with the present
invention;
[0065] FIGS. 37 and 38 are schematic views showing another form of
inflation mechanism provided in accordance with the present
invention;
[0066] FIGS. 39-58 are schematic views showing another form of
inflation mechanism provided in accordance with the present
invention;
[0067] FIG. 59 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;
[0068] FIG. 60 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;
[0069] FIGS. 61-82 are schematic views showing novel apparatus for
inflating and deflating balloons;
[0070] FIG. 83 is a schematic view showing the novel apparatus of
the present invention sealed within a novel package formed in
accordance with the present invention;
[0071] FIG. 84 is a schematic view showing details of a novel
inflation mechanism formed in accordance with the present
invention;
[0072] FIG. 85-88 are schematic views showing further details of
the novel package of FIG. 83 and further details of the novel
inflation mechanism of FIG. 84;
[0073] FIGS. 89-107 are schematic views showing preferred ways of
using the apparatus of FIG. 1;
[0074] FIG. 108 is a cross-sectional schematic view showing how
gaps are created between (i) the sleeve, (ii) the push rod lumens,
and (iii) the aft balloon inflation lumen of the apparatus of FIGS.
1-106;
[0075] FIG. 109 is a cross-sectional schematic view similar to FIG.
108, showing a plurality of novel extruded inserts filling the
aforementioned gaps between the sleeve, the push rod lumens and the
aft balloon inflation lumen, whereby to facilitate airtight bonding
of the aft balloon to the assembly;
[0076] FIGS. 110, 111 and 112 are schematic views showing novel
extruded inserts formed in accordance with the present
invention;
[0077] FIGS. 113 and 114 are schematic views showing the novel
extruded inserts of FIGS. 110, 111 and 112 disposed along the
sheath of the apparatus of FIGS. 1-106 so as to fill the gaps
between the sleeve, the push rod lumens and aft balloon inflation
lumen;
[0078] FIGS. 115-122 are schematic views showing an alternative
construction for the fore balloon;
[0079] FIG. 123 is a schematic view showing another alternative
construction for the fore balloon;
[0080] FIGS. 124 and 125 are schematic views showing an alternative
construction for the aft balloon;
[0081] FIG. 126 is a schematic view showing an alternative
construction for the hollow push tubes and push tube handle of the
present invention;
[0082] FIG. 127 is a schematic view showing another form of the
sleeve, wherein the sleeve comprises additional lumens for
receiving instruments;
[0083] FIGS. 128-131 are schematic views showing how instruments
may be advanced through the additional lumens of the sleeve;
and
[0084] FIG. 132 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.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0085] 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.
[0086] (As used herein, the term "endoscopic procedure" is intended
to mean 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.)
[0087] 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.
[0088] 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
channels of those endoscopes, such as graspers, cutters or
dissectors, cauterizing tools, ultrasound probes, etc.).
[0089] 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.
[0090] 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 which may be
initially hidden from view or outside the field of view) and/or
therapeutic intervention.
The Novel Apparatus
[0091] 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 and/or body cavity
so as to better present the side wall tissue (including
visualization of areas which may be initially hidden from view 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).
[0092] 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") 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 hollow push tubes 30 slidably mounted to sleeve
15 as will hereinafter be discussed, the pair of hollow push tubes
being connected to one another at their distal ends with a raised
push tube bridge 31, the raised push tube bridge 31 being
configured to nest an endoscope therein, and a distal (or "fore")
balloon 35 (the terms "distal" and "fore" will hereinafter be used
interchangeably) secured to the distal ends of hollow 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 hollow push tubes 30 relative to sleeve 15 (e.g., by
advancing the two hollow 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 other operator
or user).
[0093] The Sleeve 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 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 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.
[0094] 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.
[0095] 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
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.
[0096] 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.
The Aft Balloon
[0097] 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 the
exterior surface of sleeve 15 or, more preferably,
inflation/deflation tube 45 may be contained within a lumen 47
formed within sleeve 15.
[0098] 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 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 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 within the anatomy 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. 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.
[0099] 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.
[0100] In one preferred form of the invention, aft balloon 20 is
formed out of polyurethane.
The Base
[0101] 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 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.
The Pair of Hollow Push Tubes and the Push Tube Handle
[0102] The pair of hollow push tubes 30 are slidably mounted to
sleeve 15, whereby the distal ends of the hollow push tubes (and
the raised push tube bridge 31 connecting the distal ends of the
pair of hollow push tubes 30) can be extended and/or retracted
relative to sleeve 15 (e.g., by advancing or withdrawing the hollow
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, hollow 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 hollow push tubes 30 relative to support
tubes 50 (and hence minimize resistance to movement of hollow push
tubes 30 relative to sleeve 15). In this respect it should be
appreciated that minimizing resistance to the movement of hollow
push tubes 30 relative to support tubes 50 improves tactile
feedback to the user when hollow 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 hollow support tubes 50 is flexible yet has a degree
of column strength (whereas sleeve 15 alone is flexible but has
substantially no column strength). In the event that hollow push
tubes 30 are contained within lumens 52 formed in sleeve 15, and in
the event that support tubes 50 are not disposed between hollow
push tubes 30 and lumens 52, lumens 52 are preferably lubricated so
as to minimize friction between hollow push tubes 30 and lumens
52.
[0103] The distal ends of the pair of hollow push tubes 30 are
connected together with a raised push tube bridge 31 (FIG. 7).
Raised push tube bridge 31 provides a rounded structure at the
distal ends of hollow push tubes 30 which simultaneously serves to
(i) connect the distal ends of hollow push tubes 30 together, and
(ii) eliminate abrupt ends at the distal end of hollow push tubes
30 which could cause trauma to tissue, e.g., during distal
advancement of hollow push tubes 30. Raised push tube bridge 31 is
configured to nest an endoscope therein (FIG. 8).
[0104] In one preferred form of the invention, raised push tube
bridge 31 is also hollow. In this form of the invention, the hollow
raised push tube bridge 31 may be formed integral with hollow push
tubes 30, i.e., the hollow push tubes 30 and the hollow raised push
tube bridge 31 may form one continuous tube (FIGS. 9-11). Or, in
this form of the invention, the hollow raised push tube bridge 31
may be formed separately from hollow push tubes 30 and the hollow
raised push tube bridge 31 may be joined to hollow push tubes 30
during manufacturing (FIG. 12).
[0105] In one preferred form of the invention, raised push tube
bridge 31 may be substantially solid and is connected with hollow
push tubes 30 during manufacture.
[0106] If desired, raised push tube bridge 31 may be inclined
distally, e.g., in the manner shown in FIGS. 7-12.
[0107] Alternatively, if desired, raised push tube bridge 31 may be
set substantially perpendicular to the longitudinal axes of hollow
push tubes 30, e.g., in the manner shown in FIG. 13.
[0108] Furthermore, if desired, raised push tube bridge 31 may be
in the form of a ring, with endoscope 10 nesting within the
interior of the ring, e.g., in the manner shown in FIG. 14.
[0109] The proximal ends of hollow 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 hollow
push tubes 30 to move distally (at the same rate) relative to
sleeve 15 (whereby to move fore balloon 35 distally relative to aft
balloon 20) and pulling proximally on push tube handle 37 causes
the distal ends of hollow 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
hollow push tubes 30 distally or proximally at the same rate, the
distal ends of the hollow push tubes are maintained parallel to
each other. A clamp 53 (FIGS. 37 and 60) is provided at base 25 for
holding hollow push tubes 30 in a selected disposition relative to
base 25 (and hence in a selected disposition relative to sleeve
15).
[0110] Hollow push tubes 30 and raised push tube bridge 31 are
preferably formed out of a relatively flexible material which
provides good column strength, e.g., a thermoplastic polyethylene
resin such as Isoplast.TM. (available from The Lubrizol Corporation
of Wickliffe, Ohio), polyethylene, polypropylene, nylon, etc. It
should be appreciated that hollow push tubes 30 and raised push
tube bridge 31 can comprise a single material or a plurality of
materials, and that the stiffness of hollow push tubes 30 and
raised push tube bridge 31 can vary along their length. By way of
example but not limitation, the distal-most portion of hollow push
tubes 30 and raised push tube bridge 31 can be formed of the same
material as the remainder of the hollow push tubes but have a lower
modulus so as to be more flexible than the remainder of the hollow
push tubes, or the distal-most portion of hollow push tubes 30 and
raised push tube bridge 31 can comprise a different, more resilient
flexible material. By way of example but not limitation, the
distal-most portion of hollow push tubes 30 and raised push tube
bridge 31 can comprise Nitinol. By way of further example but not
limitation, the distal-most portion of hollow push tubes 30 and
raised push tube bridge 31 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
hollow push tubes 30 and raised push tube bridge 31 with distal
ends which are more flexible than the remainder of the hollow push
tubes, the hollow push tubes 30, raised push tube bridge 31 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.
[0111] In one preferred form of the invention, hollow push tubes 30
are configured to maintain a parallel disposition when they are in
an unbiased state, i.e., when no force is being applied to hollow
push tubes 30. This is true regardless of the state of inflation or
deflation of fore balloon 35. The provision of raised push tube
bridge 31 can help maintain the parallel disposition of hollow push
tubes 30.
[0112] The distal-most portion of hollow push tubes 30 can be
configured to bend inwardly or outwardly if desired e.g., via their
connection to raised push tube bridge 31. With such a
configuration, when the distal ends of hollow push tubes 30 are
held longitudinally stationary (e.g., by an inflated fore balloon,
as will hereinafter be discussed) and a sufficient
distally-directed force is applied to hollow push tubes 30, the
middle portions of hollow 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.
[0113] It should also be appreciated that by forming hollow 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 hollow push
tubes 30 from interfering with visualization of the patient's
anatomy and/or interfering with diagnostic or therapeutic tools
introduced into the space between the fore and aft balloons 35, 20.
By way of example but not limitation, if apparatus 5 is disposed in
the anatomy in such a way that a hollow push tube 30 blocks visual
or physical access to a target region of the anatomy, the flexible
hollow push tube(s) 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 hollow push tube(s) out of the
way, etc. By way of further example but not limitation, by
constructing hollow 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 hollow push tubes out of the
way and provides a unobstructed visual path to the tissue of
interest.
[0114] It should also be appreciated that, if desired, hollow 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 hollow 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.
[0115] Hollow push tubes 30 have their internal lumens (i) in fluid
communication with the interior of fore balloon 35 (FIGS. 1-5, 15
and 16), e.g., via a plurality of openings 32, and (ii) 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.
[0116] More particularly, in one preferred form of the present
invention, and looking now at FIG. 17, push tube handle 37
comprises a hollow interior 57. Hollow push tubes 30 are mounted to
push tube handle 37 so that hollow push tubes 30 will move in
conjunction with push tube handle 37, and so that the hollow
interiors of hollow 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 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,
hollow push tubes 30 are moved distally, and hence fore balloon 35
is moved distally; and when push tube handle 37 is moved
proximally, hollow push tubes 30 are moved proximally, and hence
fore balloon 35 is moved proximally. Furthermore, when positive
fluid pressure is applied to fitting 56 in base 25, positive fluid
pressure is applied to the internal lumens of hollow push tubes 30,
and hence to the interior of fore balloon 35 (i.e., via openings
32), 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 internal lumen of hollow push tubes 30,
and hence to the interior of fore balloon 35 (i.e., via openings
32), whereby to deflate fore balloon 35.
[0117] It should be appreciated that the provision of a pair of
hollow push tubes 30, connected together at their distal ends by a
raised push tube bridge 31, provides numerous advantages. By way of
example but not limitation, the provision of a pair of hollow push
tubes 30, connected together at their distal ends by a raised push
tube bridge 31, 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 a pair of
hollow push tubes 30, connected together at their distal ends by a
raised push tube bridge 31, provides equal outward forces against
the adjacent anatomy when the pair of hollow 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 a pair of hollow push tubes 30,
connected together at their distal ends by a raised push tube
bridge 31, ensures that fore balloon 35 remains centered on
endoscope 10, thereby facilitating un-docking of fore 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
a pair of hollow push tubes 30, connected together at their distal
ends by a raised push tube bridge 31, 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, the provision of a pair of hollow push tubes,
connected together at their distal ends by a raised push tube
bridge 31, provides a redundant air transfer system for inflating
or deflating fore balloon 35. And the provision of a pair of hollow
push tubes 30, connected together a their distal ends by a raised
push tube bridge 31, presents a rounded, blunt distal end for
hollow push tubes 30, thereby ensuring atraumatic advancement of
fore balloon 35 within the anatomy.
The Fore Balloon
[0118] Fore balloon 35 is secured to the distal ends of hollow push
tubes 30, with raised push tube bridge 31 being disposed within the
interior of fore balloon 35, whereby the spacing between aft
balloon 20 and fore balloon 35 can be adjusted by moving hollow
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.
[0119] Significantly, fore balloon 35 is configured so that (i)
when it is deflated (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. 15, 16 and 19) sufficient to
accommodate sleeve 15 and the shaft of endoscope 10 therein, with
raised push tube bridge 31 extending concentrically about axial
opening 63, 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
hollow push tubes 30 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 balloons will create
a sealed zone therebetween (sometimes hereinafter referred to as
"the therapeutic zone").
[0120] It will be appreciated that, when fore balloon 35 is
reconfigured from its deflated condition to its inflated condition,
fore balloon 35 expands radially inwardly (so as to close down
axial opening 63) as well as radially outwardly (so as to engage
the surrounding tissue). Note that hollow push tubes 30 and raised
push tube bridge 31 are disposed within fore balloon 35 in such a
way that their presence within the fore balloon does not physically
interfere with inflation or deflation of fore balloon 35.
[0121] 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).
[0122] To this end, and looking now at FIGS. 18 and 19, 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
a circular cross-section. Note that lobes 74 are disposed on
proximal extension 73 with a configuration which matches the
configuration of hollow push tubes 30 (i.e., where apparatus 5
comprises two hollow push tubes 30 diametrically opposed to one
another, proximal extension 73 will comprise two lobes 74
diametrically opposed to one another--for the purposes of the
present invention, proximal extension 73 and lobe(s) 74 may be
collectively referred to as having a "key-shaped" cross-section).
During assembly, proximal extension 73 is everted into the interior
of body 67, hollow push tubes 30 are seated in lobes 74 of proximal
extension 73, (with the interiors of hollow push tubes 30 being in
fluid communication with the interior of body 67 and with raised
push tube bridge 31 disposed within 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 hollow push tubes 30 being
secured to fore balloon 35 and communicating with the interior of
fore balloon 35, and with raised push tube bridge 31 being disposed
concentrically about axial opening 63. Significantly, axial opening
63 is sized to receive the distal end of endoscope 10 therein, and
raised push tube bridge 31 is sized to nest endoscope 10 in the
area beneath the raised push tube bridge 31. Also significantly,
the formation of fore 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
hollow push tubes 30, thereby providing a more robust balloon
construction. Among other things, providing multiple layers of
balloon material around hollow push tubes 30 adds cushioning to the
distal ends of hollow push tubes 30, thereby providing an even more
atraumatic distal tip to hollow push tubes 30 and further ensuring
that the distal tips of hollow push tubes 30 do not damage the
adjacent tissue.
[0123] In one preferred form of the invention, fore balloon 35 is
formed out of polyurethane.
[0124] 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 hollow push tubes 30 and raised push
tube bridge 31 (while still allowing hollow push tubes 30 to be in
fluid communication with the interior of fore balloon 35, i.e., via
openings 32), thereby providing an atraumatic tip for advancing
fore balloon 35 distally through a body lumen. Furthermore, hollow
push tubes 30, raised push tube bridge 31 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. 93).
[0125] If desired, one or both of aft balloon 20 and fore balloon
35 can be marked 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.
Alternative Construction for the Base and the Push Tube Handle
[0126] As noted above, and as shown in FIG. 1, apparatus 5
comprises a base 25 which is secured to sleeve 15 at the proximal
end of the sleeve and which carries fittings 46, 56 for
inflating/deflating aft balloon 20 and/or fore balloon 35,
respectively. Apparatus 5 also comprises a push tube handle 37
which has hollow push tubes 30 mounted thereto, with hollow push
tubes 30 physically supporting (and providing fluid communication
to) the interior of fore balloon 35. As also noted above, proximal
inflation/deflation tube 45 provides fluid communication between
fitting 46 of base 25 and the interior of aft balloon 20; and a
flexible tube 59 provides (with other elements) fluid communication
between fitting 56 of base 25 and the interior of hollow push tubes
30 (and hence the interior of fore balloon 35).
[0127] With the construction shown in FIG. 1, base 25 supports and
guides hollow push tubes 30 as they are advanced distally or
retracted proximally, but base 25 does not directly support and
guide push tube handle 37 as it is advanced distally or retracted
proximally.
[0128] To that end, if desired, and looking now at FIGS. 20-25,
apparatus 5 may comprise a similar but somewhat different base
(i.e., the base 25A) and a similar but somewhat different push tube
handle (i.e., the push tube handle 37A). Base 25A comprises an
extension 205 which has the aforementioned fittings 46, 56 mounted
thereto. Extension 205 comprises a center slot 210 and a pair of
side slots 215. Push tube handle 37A comprises a C-shaped body 220
having hollow push tubes 30 mounted thereto, and having a center
locking element 225 and a pair of finger grips 230 mounted thereto.
Locking element 225 preferably comprises a screw shaft 235 and a
screw knob 240, such that screw knob 240 can be advanced towards or
away from body 220 by turning the screw knob.
[0129] Push tube handle 37A is mounted within extension 205 of base
25A so that screw shaft 235 is slidably received in center slot 210
and so that finger grips 230 are slidably received in side slots
215, whereby to provide support and guidance to push tube handle
37A.
[0130] As a result of this construction, push tube handle 37A can
be moved distally or proximally by moving screw shaft 235 and
finger grips 230 distally or proximally, whereby to move fore
balloon 35 distally or proximally; and push tube handle 37A can be
locked in position relative to body 25A by turning screw knob 240
so that it securely engages the outer surface of extension 205,
whereby to lock fore balloon 35 in position relative to body 25A.
Note that torsion can be applied to fore balloon 35 by applying
torsion to finger grips 230, e.g., by moving one side wing 230
distally while pulling the other side wing 230 proximally.
[0131] FIGS. 26-30 show different configurations for screw knob
240.
[0132] If desired, lubricious washers 245 may be added to the
assembly to reduce friction (FIG. 31), or texture may be added to
surfaces (e.g., the underside of screw knob 240 as shown in FIG.
32) so as to increase friction. Furthermore, finger grips 230 may
be shaped differently than those illustrated in FIGS. 20-30, or
moved to a different portion of the assembly. See, for example,
FIG. 33, which shows finger grips 230 formed as part of a second
knob 250 which keys to the slider assembly.
[0133] It should also be appreciated that, if desired, push tube
handle 37A may comprise a generally C-shaped body having a
different configuration from the C-shaped body 220 shown in FIGS.
23, 25, 31 and 33. By way of example but not limitation, and
looking now at FIG. 34, C-shaped body 220 may comprise a pair of
downwardly extending legs 255 connected by a linkage 260.
The Inflation Mechanism
[0134] Inflation mechanism 40 provides a means to selectively
inflate aft balloon 20 and/or fore balloon 35.
[0135] In one preferred form of the present invention, and looking
now at FIGS. 1 and 35, 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 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 interiors of hollow push tubes 30 and out
of openings 32).
[0136] In another preferred form of the present invention, and
looking now at FIG. 36, 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.
[0137] 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 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.
[0138] Alternatively, and looking now at FIGS. 37 and 38, a syringe
160 may be 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 fore balloon 35 or aft balloon 20, and a valve 170
for selecting inflation or deflation of the connected-to
balloon.
[0139] 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 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.
[0140] 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.
[0141] In another preferred form of the present invention, and
looking now at FIGS. 39-58, inflation mechanism 40 comprises a hand
inflator 300 also formed in accordance with the present invention.
Hand inflator 300 generally comprises a housing 305 carrying a bulb
or "pump" 310, an aft balloon inflation line 315 (for connection to
fitting 46 of apparatus 5, see FIG. 1), a fore balloon inflation
line 320 (for connection to fitting 56 of apparatus 5, see FIG. 1),
and internal pneumatic apparatus 325 (FIG. 42) for directing air
between pump 310 and aft balloon inflation line 315 and fore
balloon inflation line 320 (and for venting air from aft balloon
inflation line 315 and fore balloon inflation line 320), all as
will hereinafter be discussed.
[0142] As seen in FIGS. 42 and 43, internal pneumatic apparatus 325
comprises a check valve 330, a check valve 335, a check valve 340,
a multi-way valve 345, a fore balloon indicator 350, an aft balloon
indicator 355, a check valve 360, a check valve 365, an "air in"
port 367 and an "air out" port 368. A selector knob 370 (FIGS. 39,
40 and 41) is attached to multi-way valve 345 so as to allow the
user to set multi-way valve 345 as desired, and openings 375, 380
(FIG. 40) are formed in housing 305 so as to expose fore balloon
indicator 350 and aft balloon indicator 355, respectively, to the
view of the user.
[0143] Looking now at FIGS. 44 through 47, internal pneumatic
apparatus 325 is configured so that (i) aft balloon 20 can be
selectively inflated by pump 310, (ii) aft balloon 20 can be
selectively deflated by pump 310, (iii) fore balloon 35 can be
selectively inflated by pump 310, and (iv) fore balloon 35 can be
selectively deflated by pump 310.
[0144] More particularly, when aft balloon 20 is to be inflated,
and looking now at FIG. 44, selector knob 370 is set so that
multi-way valve 345 creates a fluid line connecting "air in" port
367, check valve 340, check valve 335, pump 310, check valve 330,
aft balloon indicator 355, check valve 365, aft balloon inflation
line 315 and aft balloon 20, so that repeated compressions of pump
310 inflates aft balloon 20, with the pressure within aft balloon
20 being indicated by aft balloon indicator 355.
[0145] When aft balloon 20 is to be deflated, and looking now at
FIG. 45, selector knob 370 is set so that multi-way valve 345
creates a fluid line connecting aft balloon 20, aft balloon
inflation line 315, check valve 365, aft balloon indicator 355,
check valve 340, check valve 335, pump 310, check valve 330 and
"air out" port 368, so that repeated compressions of pump 310
deflates aft balloon 20, with the pressure within aft balloon 20
being indicated by aft balloon indicator 355.
[0146] When fore balloon 35 is to be inflated, and looking now at
FIG. 46, selector knob 370 is set so that multi-way valve 345
creates a fluid line connecting "air in" port 367, check valve 340,
check valve 335, pump 310, check valve 330, fore balloon indicator
350, check valve 360, fore balloon inflation line 320 and fore
balloon 35, so that repeated compressions of pump 310 inflates fore
balloon 35, with the pressure within fore balloon 35 being
indicated by fore balloon indicator 350.
[0147] When fore balloon 35 is to be deflated, and looking now at
FIG. 47, selector knob 370 is set so that multi-way valve 345
creates a fluid line connecting fore balloon 35, fore balloon
inflation line 320, check valve 360, fore balloon indicator 350,
check valve 340, check valve 335, pump 310, check valve 330 and
"air out" port 368, so that repeated compressions of pump 310
deflates fore balloon 35, with the pressure within fore balloon 35
being indicated by fore balloon indicator 350.
[0148] In one preferred form of the invention, and looking now at
FIGS. 48 and 13K, fore balloon indicator 350 and aft balloon
indicator 355 each comprise a piston 385. Piston 385 is created by
attaching two end caps 390, 395 together with a pliable extrusion
400. End cap 390 is securely mounted to housing 305 and is
pneumatically connected by a tube 405 to the system pressure which
is to be measured (i.e., to a balloon, either the fore balloon 35
or the aft balloon 20, depending on whether piston 385 is employed
in fore balloon indicator 350 or aft balloon indicator 355). End
cap 395 rides along tube 405 and abuts a spring 410 which engages a
wall 415 of housing 305. End cap 395 includes an alignment feature
420 which is slidably disposed in a guide (not shown) in housing
305, and a color pressure indicator 425 which is visible through
one or the other of the aforementioned openings 375, 380 (depending
on whether piston 385 is employed in fore balloon indicator 350 or
aft balloon indicator 355). End cap 395 acts as the pressure
indicator, inasmuch as the longitudinal position of second end cap
395 along tube 405 (relative to wall 415) is an indicator of system
pressure. In essence, the two end caps 390, 395 and extrusion 400
effectively constitute a piston (i.e., piston 385) which expands
and contracts as the system pressure changes, with system pressure
being reflected by the disposition of color pressure indicator 425
relative to one or the other of the aforementioned openings 375,
380.
[0149] When there is no pressure in the system (i.e., when the fore
balloon or the aft balloon is entirely deflated), the indicator
remains in the position shown in FIG. 50. In this position,
extrusion 400 is collapsed and folded upon itself. When pressure is
introduced into the system (and hence, into tube 405) and a balloon
(i.e., fore balloon 35 or aft balloon 20) begins to inflate, end
cap 395 begins to move relative to tube 405, compressing spring
410. The distance that end cap 395 moves depends on the pressure in
the system (i.e., the pressure within tube 405), the diameter of
the extrusion, and the bias force of the spring. FIG. 51 shows
piston 385 and extrusion 400 fully extended (i.e., indicating
maximum pressure within the system or, to put it another way,
complete inflation of either fore balloon 35 or aft balloon 20).
Ideally, the fully-extended position of color pressure indicator
425 relative to openings 375, 380 in housing 305 correlates to the
maximum allowable pressure of fore balloon 35 or aft balloon
20.
[0150] It should be appreciated that since the position of a color
pressure indicator 425 relative to an opening 375, 380 in housing
305 is reflective of the pressure within the system (i.e., the
pressure within either fore balloon 35 or aft balloon 20), in one
preferred form of the present invention, various colors (e.g.,
green, yellow and red) are used to correspond to various
predetermined pressures within the system.
[0151] Thus, the design shown in FIGS. 48-53 comprises a colored
indicator (i.e., color pressure indicator 425) attached to the
"dynamic" (i.e., moving) end cap 395 of piston 385. The color
scheme on each indicator alerts the user as to how "full" (i.e.,
how inflated) each of the balloons (i.e., fore balloon 35 or aft
balloon 20) is. However, it should also be appreciated that, if
desired, the indicator could comprise numeric pressure values
instead of colors. Alternatively, the pressure level could be
indicated by a strip of colors (or numbers) fixed to the housing
(i.e., adjacent openings 375, 380 in housing 305). In this form of
the invention, the end cap 395 comprises a pointer which extends
out of opening 375 or 380 and, as the piston expands (i.e., as
pliable extrusion 400 expands and end cap 395 moves toward wall 415
against the power of spring 410) and contracts (i.e., as pliable
extrusion 400 contracts and end cap 395 moves away from wall 415
under the power of spring 410), the pointer points to the
appropriate pressure indication mark on housing 305.
[0152] The design shown in FIGS. 48-53 illustrates the two end caps
390, 395 of piston 385 being separated by a tubular pliable
extrusion 400. However, it should also be appreciated that, if
desired, pliable extrusion 400 may be replaced by a balloon 430
(FIG. 54). Balloon 430 is preferably spherical (FIG. 54), although
it may also comprise other shapes if desired (see, for example,
FIG. 55, which shows a generally diamond-shaped balloon 430, and
FIG. 56 which shows a generally tubular balloon 430). Or, if
desired, balloon 430 may be used to push a flag upward, i.e.,
perpendicular to the axis of the balloon, instead of expanding a
piston along its axis. See FIGS. 57 and 58.
[0153] 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.
[0154] If desired, and looking now at FIG. 59, 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. 59, 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.
[0155] Alternatively, and/or additionally, one or more pressure
gauges 182 (FIG. 1 or FIG. 38) 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 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.
[0156] 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. 60, a flexible tube retraction system 185 may be provided
(e.g., within base 25) to take up slack in flexible tube 59 when
fore balloon 35 is extended.
Hand Inflator Incorporating a Novel Manifold
[0157] As discussed above, in one preferred form of the invention,
inflation mechanism 40 comprises a hand inflator 300 (FIGS. 39-58)
for selectively inflating/deflating a selected one of fore balloon
35 and aft balloon 20. Hand inflator 300 generally comprises a
manual pump (e.g., bulb 310) for providing an air pressure/suction
source, and a multi-way valve 345 for directing the flow of air
from/to bulb 310 to/from a selected one of fore balloon 35 and aft
balloon 20.
[0158] In one form of the present invention, and looking first at
FIGS. 61 and 62, multi-way valve 345 preferably takes the form of a
novel manifold 500 disposed within housing 305 of hand inflator
300. Manifold 500 generally comprises a bottom plate 505
fluidically connected to bulb 310, a rotatable middle plate 510,
and a top plate 515 fluidically connected to fore balloon 35, aft
balloon 20, fore balloon indicator 350 and aft balloon indicator
355. A shaft 520 passes through, and connects together, top plate
515, middle plate 510 and bottom plate 505, as will hereinafter be
discussed in further detail. Looking next at FIG. 63, bottom plate
505 generally comprises a body 525 having a cavity 530 formed
therein. Bottom plate 505 also comprises an inflation port 535
configured to be fluidically connected to an air pressure source
(e.g., bulb 310) and a deflation port 540 configured to be
fluidically connected to an air suction source (e.g., bulb 310).
Inflation port 535 and deflation port 540 are fluidically connected
to cavity 530, as will hereinafter be discussed in further
detail.
[0159] Cavity 530 of bottom plate 505 comprises (i) a central
opening 545 which passes through body 525 of bottom plate 505 for
rotatably receiving shaft 520 therein, and (ii) a plurality of
O-rings 550 which are disposed in cavity 530 and arranged
concentrically about central opening 545. O-rings 550 define two
ring-shaped zones which are disposed coaxially relative to one
another and which can be fluidically isolated from one another
(i.e., when middle plate 510 is mounted on top of bottom plate 505
and covers cavity 530, as will hereinafter be discussed). More
particularly, O-rings 550 define an inner deflation zone 555 and an
outer inflation zone 560 disposed coaxially about inner deflation
zone 555. Inner deflation zone 555 comprises an opening 565 which
is fluidically connected to deflation port 540, and outer inflation
zone 560 comprises an opening 570 which is fluidically connected to
inflation port 535. In one preferred form of the invention, bottom
plate 505 also comprises a check valve 575 fluidically connected to
deflation port 540 for allowing bulb 310 to "re-form" (i.e., draw
air through check valve 575) when it is not possible to draw air
from atmosphere through inner deflation zone 555 (it will be
appreciated that check valve 575 is functionally equivalent to the
check valve 340 shown in FIG. 65).
[0160] Looking next at FIG. 64, middle plate 510 comprises a body
580 having a smooth bottom surface 585 for sealingly engaging
O-rings 550 disposed in cavity 530 of bottom plate 505 (whereby to
fluidically seal inner deflation zone 555 and outer inflation zone
560), and a smooth top surface 590 for sealingly engaging top plate
515, as will hereinafter be discussed in further detail. Body 580
of middle plate 510 comprises a central opening 595 which passes
through body 580 of middle plate 510 and is configured to engage
shaft 520 (e.g., central opening 595 may comprise a non-circular
cross-section which mates with a portion of shaft 520 having a
corresponding non-circular cross-section) such that rotation of
shaft 520 causes corresponding rotation of middle plate 510. Middle
plate 510 also comprises an inner hole 600 and an outer hole 605
which are disposed on a common radius and which pass through body
580 of middle plate 510. Inner hole 600 is disposed so as to be in
common orbit with, and fluidically connected to, inner deflation
zone 555 of bottom plate 505 when middle plate 510 is mounted over
bottom plate 505. Outer hole 605 is disposed so as to be in common
orbit with, and fluidically connected to, outer inflation zone 560
of bottom plate 505 when middle plate 510 is mounted over bottom
plate 505.
[0161] Looking next at FIGS. 65-67, top plate 515 comprises a body
610 having a bottom surface 615, a top surface 620 and a central
opening 625 passing through body 610 for rotatably receiving shaft
520. Top plate 515 also comprises an aft balloon connection port
630 for fluidically connecting aft balloon 20 to manifold 500, an
aft balloon indicator port 635 for fluidically connecting aft
balloon indicator 355 to manifold 500, an aft balloon channel 640
extending between aft balloon connection port 630 and aft balloon
indicator port 635, a fore balloon connection port 645 for
fluidically connecting fore balloon 35 to manifold 500, a fore
balloon indicator port 650 for fluidically connecting fore balloon
indicator 350 to manifold 500 and a fore balloon channel 655
extending between fore balloon connection port 645 and fore balloon
indicator port 650.
[0162] Bottom surface 615 of body 610 comprises an aft balloon
inflation port 660 and an aft balloon deflation port 665 which open
on bottom surface 615 and which are fluidically connected to aft
balloon channel 640. Bottom surface 615 of body 610 also comprises
a fore balloon inflation port 670 and a fore balloon deflation port
675 which open on bottom surface 615 and which are fluidically
connected to fore balloon channel 655. A plurality of O-rings 680
are disposed about ports 660, 665, 670, 675 for effecting sealing
engagement of ports 660, 665, 670, 675 with top surface 590 of
middle plate 510 as will hereinafter be discussed in further
detail. In one preferred form of the present invention, bottom
surface 615 of body 610 also comprises a balance O-ring 685 for
helping to maintain sealing engagement of O-rings 680 with top
surface 590 of middle plate 510, as will hereinafter be discussed
in further detail.
[0163] In one preferred form of the invention, top plate 515 also
comprises an aft balloon channel check valve 690 disposed in top
plate 515 (it will be appreciated that check valve 690 is
functionally equivalent to the check valve 365 shown in FIG. 65).
Aft balloon check valve 690 is in fluid communication with aft
balloon channel 640 and prevents over-inflation of aft balloon 20
by releasing air to atmosphere when the air pressure within aft
balloon channel 640 (which is the same as the air pressure within
aft balloon 20) exceeds a predetermined threshold. In one preferred
form of the invention, top plate 515 also comprises a fore balloon
channel check valve 695 disposed in top plate 515 (it will be
appreciated that check valve 695 is functionally equivalent to the
check valve 360 shown in FIG. 43). Fore balloon check channel valve
695 is in fluid communication with fore balloon channel 655 and
prevents over-inflation of fore balloon 35 by releasing air to
atmosphere when the air pressure within fore balloon channel 655
(which is the same as the air pressure within fore balloon 35)
exceeds a predetermined threshold.
Assembly of the Novel Manifold
[0164] Looking next at FIGS. 68 and 69, manifold 500 is assembled
such that middle plate 510 is rotatably disposed between bottom
plate 505 and top plate 515, with shaft 520 passing through central
opening 625 of top plate 515, through central opening 595 of middle
plate 510 and through central opening 545 of bottom plate 505. More
particularly, the distal end of shaft 520 comprises a distal
bearing 700 which is secured to shaft 520 by a retainer clip 705.
The proximal end of shaft 520 comprises a proximal bearing 710
which is secured to the proximal end of shaft 520, with a spring
715 being disposed between proximal bearing 710 and top surface 620
of top plate 515. A selector knob 720 is fixedly mounted to the
proximal end of shaft 520 such that rotation of selector knob 720
causes corresponding rotation of shaft 520 (and hence corresponding
rotation of middle plate 510). Shaft 520 is able to rotate freely
within central opening 625 of top plate 515 and central opening 545
of bottom plate 505, and to also rotate freely within proximal
bearing 710 and distal bearing 700. However, shaft 520 engages
central opening 595 of middle plate 510 such that rotation of shaft
520 causes corresponding rotation of middle plate 510, whereby to
permit a user to selectively rotate middle plate 510 (i.e., by
rotating selector knob 720, which, in turn, rotates middle plate
510).
[0165] It will be appreciated that when the various components are
assembled on shaft 520, bottom plate 505, middle plate 510 and top
plate 515 are "sandwiched" between distal bearing 700 and proximal
bearing 710 under compression provided by spring 715, whereby to
maintain constant contact (i) between bottom surface 585 of middle
plate 510 and O-rings 550 of bottom plate 505, (ii) between top
surface 590 of middle plate 510 and O-rings 680 of top plate 515
(i.e., between top surface 590 of middle plate 510 and aft balloon
inflation port 660, aft balloon deflation port 665, fore balloon
inflation port 670 and fore balloon deflation port 675), and (iii)
between top surface 590 of middle plate 510 and balance O-ring 685
of top plate 515.
[0166] As a result, an air-tight air pathway is maintained through
manifold 500 between a selected one of (i) inflation port 535 or
deflation port 540, and (ii) a selected one of fore balloon 35 or
aft balloon 20, such that bulb 310 may be used to selectively
inflate or deflate a selected one of fore balloon 35 or aft balloon
20, as will hereinafter be discussed in further detail.
[0167] More particularly, it will be appreciated that rotating
selector knob 720 causes shaft 520 to rotate, thereby causing
middle plate 510 to rotate. When this occurs, inner hole 600 and
outer hole 605 of middle plate 510 also rotate relative to bottom
plate 505 and top plate 515. Since inner hole 600 of middle plate
510 is aligned in common orbit with inner deflation zone 555 of
bottom plate 505, inner hole 600 is always aligned with inner
deflation zone 555, regardless of the rotational position of middle
plate 510 (and hence, inner hole 600 is always fluidically
connected to deflation port 540, i.e., vis-a-vis opening 565 in
inner deflation zone 555). Similarly, since outer hole 605 of
middle plate 510 is aligned in common orbit with outer inflation
zone 560 of bottom plate 505, outer hole 605 is always aligned with
outer inflation zone 560 (and hence, outer hole 605 is always
fluidically connected to inflation port 535 vis-a-vis opening 570
in outer inflation zone 560).
[0168] It will also be appreciated that when middle plate 510 is
rotated (i.e., by rotating selector knob 720), inner hole 600 of
middle plate 510 may be positioned so that it is (i) aligned with
aft balloon deflation port 665, or (ii) aligned with fore balloon
deflation port 675, or (iii) unaligned with a port 665, 675 (and
hence open to atmosphere). Similarly, outer hole 605 of middle
plate 510 may be positioned so that it is (i) aligned with aft
balloon inflation port 660, or (ii) aligned with fore balloon
inflation port 670, or (iii) unaligned with a port 660, 670 (and
hence open to atmosphere). In this respect it will be appreciated
that the provision of O-rings 680 and balance O-ring 685 creates a
small gap between bottom surface 615 of top plate 515 and top
surface 590 of middle plate 510, such that when either (or both) of
inner hole 600 and/or outer hole 605 of middle plate 510 are
unaligned with a port 665, 675, 660, 670, inner hole 600 and/or
outer hole 605 are connected with atmosphere.
[0169] As a result of this construction, it will be appreciated
that middle plate 510 can be selectively rotated so as to occupy
one of five states: (1) an aft balloon inflation state, wherein
outer hole 605 of middle plate 510 is aligned with aft balloon
inflation port 660 of top plate 515 and inner hole 600 of middle
plate 510 is open to atmosphere ("State 1"); (2) an aft balloon
deflation state wherein outer hole 605 of middle plate 510 is open
to atmosphere and inner hole 600 of middle plate 510 is aligned
with aft balloon deflation port 665 of top plate 515 ("State 2");
(3) a fore balloon inflation state wherein outer hole 605 of middle
plate 510 is aligned with fore balloon inflation port 670 of top
plate 515 and inner hole 600 of middle plate 510 is open to
atmosphere ("State 3"); (4) a fore balloon deflation state wherein
outer hole 605 of middle plate 510 is open to atmosphere and inner
hole 600 of middle plate 510 is aligned with fore balloon deflation
port 675 ("State 4"); or (5) an inactive state wherein neither
outer hole 605 nor inner hole 600 of middle plate 510 is aligned
with a port 660, 665, 670, 675 in top plate 515, i.e., wherein both
outer hole 605 and inner hole 600 are open to atmosphere and with
ports 660, 665, 670, 675 of top plate 515 being fluidically sealed
against top surface 590 of middle plate 510 ("State 5").
[0170] Thus it will be seen that the relative positions of aft
balloon inflation port 660, aft balloon deflation port 665, fore
balloon inflation port 670 and fore balloon deflation port 675
within bottom surface 615 of top plate 515 can be arranged such
that rotation of middle plate 510 causes selective switching
between the States 1, 2, 3, 4 and 5 discussed above.
[0171] By way of example but not limitation, in one preferred form
of the present invention, State 1 is effected when knob 720 is in
the "8 o'clock" position, State 2 is effected when knob 720 is in
the "4 o'clock" position, State 3 is effected when knob 720 is in
the "10 o'clock" position, and State 4 is effected when knob 720 is
in the "2 o'clock" position. In this form of the invention, State 5
is effected whenever knob 720 is rotated to a position intermediate
the aforementioned positions.
[0172] 1. Aft Balloon Inflation. Looking now at FIGS. 70-72, there
is shown the path that air travels through manifold 500 when middle
plate 510 is in State 1 discussed above for effecting aft balloon
inflation (i.e., when middle plate 510 is rotated such that outer
hole 605 of middle plate 510 is aligned with aft balloon inflation
port 660 of top plate 515 and inner hole 600 of middle plate 510 is
open to atmosphere). In State 1, when bulb 310 is squeezed and
released, free air from atmosphere is drawn into inner hole 600 of
middle plate 510, passes into inner deflation zone 555 of bottom
plate 505, through opening 565 in inner deflation zone 565, through
deflation port 540, into bulb 310 and then back out of bulb 310,
into inflation port 535, through opening 570, into outer inflation
zone 560, through outer hole 605 of middle plate 510, into aft
balloon inflation port 660, through aft balloon channel 640, out of
aft balloon connection port 630 and into aft balloon 20. It should
be appreciated that as this occurs, and looking now at FIG. 72, aft
balloon deflation port 665, fore balloon inflation port 670 and
fore balloon deflation port 675 are all fluidically sealed against
top surface 590 of middle plate 510 so that air cannot enter or
leave via ports 665, 670, 675, and hence, when manifold 500 is in
State 1, inflation of aft balloon 20 does not have any effect on
fore balloon 35.
[0173] 2. Aft Balloon Deflation. Looking next at FIGS. 73 and 74,
there is shown the path that air travels through manifold 500 when
middle plate 510 is in State 2 discussed above for effecting aft
balloon deflation (i.e., when middle plate 510 is rotated such that
outer hole 605 of middle plate 510 is open to atmosphere and inner
hole 600 of middle plate 510 is aligned with aft balloon deflation
port 665). In State 2, when bulb 310 is squeezed and released, air
from aft balloon 20 is drawn into aft balloon connection port 630,
through aft balloon channel 640, out aft balloon deflation port
665, through inner hole 600 of middle plate 510, into inner
deflation zone 555, through opening 565, out deflation port 540,
into bulb 310, back out of bulb 310, into inflation port 535,
through opening 570 in outer inflation zone 560, into outer
inflation zone 560, through outer hole 605 of middle plate 510 and
out to atmosphere. It should be appreciated that as this occurs,
aft balloon inflation port 660, fore balloon inflation port 670 and
fore balloon deflation port 675 are all fluidically sealed against
top surface 620 of middle plate 510 so that air cannot enter or
leave via ports 660, 670, 675, and hence, when manifold 500 is in
State 2, deflation of aft balloon 20 does not have any effect on
fore balloon 35.
[0174] 3. Fore Balloon Inflation. Looking next at FIGS. 75 and 76,
there is shown the path that air travels through manifold 500 when
middle plate 510 is in State 3 discussed above for effecting fore
balloon inflation (i.e., when middle plate 510 is rotated such that
outer hole 605 of middle plate 510 is aligned with fore balloon
inflation port 670 of top plate 515 and inner hole 600 of middle
plate 510 is open to atmosphere). In State 3, when bulb 310 is
squeezed and released, free air from atmosphere is drawn into inner
hole 600 of middle plate 510, passes into inner deflation zone 555
of bottom plate 505, through opening 565 in inner deflation zone
565, through deflation port 540, into bulb 310 and then back out of
bulb 310, into inflation port 535, through opening 570, into outer
inflation zone 560, through outer hole 605 of middle plate 510,
into fore balloon inflation port 670, through fore balloon channel
655, out of fore balloon connection port 645 and into fore balloon
35. It should be appreciated that as this occurs, aft balloon
deflation port 665, aft balloon inflation port 660 and fore balloon
deflation port 675 are all fluidically sealed against top surface
590 of middle plate 510 so that air cannot enter or leave via ports
665, 660, 675, and hence, when manifold 500 is in State 3,
inflation of fore balloon 35 does not have any effect on aft
balloon 20.
[0175] 4. Fore Balloon Deflation. Looking next at FIGS. 77 and 78,
there is shown the path that air travels through manifold 500 when
middle plate 510 is in State 4 discussed above for effecting fore
balloon deflation (i.e., when middle plate 510 is rotated such that
outer hole 605 of middle plate 510 is open to atmosphere and inner
hole 600 of middle plate 510 is aligned with fore balloon deflation
port 675). In State 4, when bulb 310 is squeezed and released, air
from fore balloon 35 is drawn into fore balloon connection port
645, through fore balloon channel 655, through fore balloon
deflation port 675, through inner hole 600 of middle plate 510,
into inner deflation zone 555, through opening 565, through
deflation port 540, into bulb 310, back out of bulb 310 into
inflation port 535, through opening 570 in outer inflation zone
560, into outer inflation zone 560, and through outer hole 605 of
middle plate 510 and into atmosphere. It should be appreciated that
as this occurs, aft balloon inflation port 660, aft balloon
deflation port 665 and fore balloon inflation port 670 are all
fluidically sealed against top surface 590 of middle plate 510 so
that air cannot enter or leave ports 660, 665, 670, and hence, when
manifold 500 is in State 4, deflation of fore balloon 35 does not
have any effect on aft balloon 20.
[0176] 5. Fore Balloon And Aft Balloon Sealed Against
Inflation/Deflation. When middle plate 510 is disposed in State 5
discussed above (i.e., when middle plate 510 is rotated such that
inner hole 600 and outer hole 605 are both open to atmosphere), aft
balloon inflation port 660, aft balloon deflation port 665, fore
balloon inflation port 670 and fore balloon deflation port 675 are
all sealed against top surface 590 of middle plate 510. In State 5,
squeezing and releasing of bulb 310 has no effect on either fore
balloon 35 or aft balloon 20 (inasmuch as air is drawn into inner
hole 600 of middle plate 510, enters inner deflation zone 555,
passes through opening 565, passes out deflation port 540 and into
bulb 310, and is then passed from bulb 310, into inflation port
535, through opening 570 and into outer inflation zone 560, and
then out through outer hole 605 to atmosphere).
Alternative Novel Manifold
[0177] It should be appreciated that other manifolds may be
utilized in inflation mechanism 40 in place of the novel manifold
500 discussed above.
[0178] By way of example but not limitation, and looking now at
FIG. 79, there is shown another novel manifold 500A for selectively
inflating or deflating a selected one of aft balloon 20 and fore
balloon 35. Manifold 500A serves the same function as manifold 500
discussed above (i.e., manifold 500A selectively controls a
plurality of airway paths in order to permit a user to selectively
inflate or deflate a selected one of aft balloon 20 and fore
balloon 35 using a single user interface), however, manifold 500A
employs a somewhat different construction than manifold 500.
[0179] Looking now at FIG. 80, manifold 500A generally comprises a
rotatable control dial and a plurality of tubes (labelled 1-6 in
FIG. 80), with the control dial being configured to selectively
close-off one or more of the plurality of tubes and to selectively
open one or more of the plurality of tubes as the rotatable control
dial is rotated. More particularly, and still looking at FIG. 80,
there is shown a rotatable control dial 800 comprising a body 805.
Body 805 comprises a first groove 810 having a first cutout section
815 and a second cutout section 820, a second groove 825 having a
first cutout section 830 and a second cutout section 835, a third
groove 840 having a cutout section 845, a fourth groove 850 having
a cutout section 855, a fifth groove 860 having a cutout section
865 and a sixth groove 870 having a cutout section 875.
[0180] The plurality of tubes discussed above are fixed in place
relative to rotatable control dial 800 and each of the plurality of
tubes passes through one of first groove 810, second groove 825,
third groove 840, fourth groove 850, fifth groove 860 and sixth
groove 870. More particularly, a first tube 880 in fluid connection
with bulb 310 and atmosphere passes through first groove 810, a
second tube 885 in fluid connection with bulb 310 and atmosphere
passes through second groove 825, a third tube 890 in fluid
connection with aft balloon 20 and bulb 310 passes through third
groove 840, a fourth tube 895 in fluid connection with aft balloon
20 and bulb 310 passes through fourth groove 850, a fifth tube 900
in fluid connection with fore balloon 35 and bulb 310 passes
through fifth groove 860, and a sixth tube 905 in fluid connection
with fore balloon 35 and bulb 310 passes through sixth groove
870.
[0181] First groove 810, second groove 825, third groove 840,
fourth groove 850, fifth groove 860 and sixth groove 870 are sized
such that first tube 880, second tube 885, third tube 890, fourth
tube 895, fifth tube 900 and sixth tube 905 are "pinched off" such
that air cannot flow throw the tube whenever the tube is disposed
in a section of its respective groove 810, 825, 840, 860, 870 which
is not a cutout section. As a result, air can only flow through a
given tube 880, 885, 890, 895, 900, 905 when the tube is disposed
in a cutout section formed in the groove that the tube is disposed
in.
[0182] More particularly, first tube 880 only permits passage of
air through the tube when it is disposed in either cutout section
815 or cutout section 820 of first groove 810, second tube 885 only
permits passage of air through the tube when it is disposed in
either cutout section 830 or cutout section 835, third tube 890
only permits passage of air through the tube when it is disposed in
cutout section 845, etc. Since tubes 880, 885, 890, 895, 900 and
905 are fixed in location relative to control dial 800, when
control dial 800 is selectively rotated by a user, cutout sections
815, 820, 830, 835, 845, 855, 865 and 875 move relative to tubes
880, 885, 890, 895, 900 and 905. By controlling where the cutout
sections 815, 820, 830, 835, 845, 855, 865 and 875 are formed in
body 805 of control dial 800, it is possible to control which of
the tubes 880, 885, 890, 895, 900 and 905 will be "pinched off" and
which will reside in a cutout section 815, 820, 830, 835, 845, 855,
865 and 875 when control dial 800 is rotated to a given position.
Thus it is possible to control the flow of air to and from bulb
310, and to simultaneously control the flow of air to and from a
selected one of aft balloon 20 and fore balloon 35, by selectively
moving control dial 800 to a specific position. Further details
regarding the flow of air through manifold 500A are provided in
FIGS. 81 and 82.
Venting of Balloons Through Packaging Design
[0183] In one preferred form of the present invention, and looking
now at FIG. 83, novel apparatus 5 is sealed within a sterile
package 1000 until novel apparatus 5 is to be used. Package 1000 is
typically provided in the form of a bottom tray 1005 which is sized
to hold novel apparatus 5, and a cover 1010 for mating to, and
sealing off, bottom tray 1005. Fore balloon 35 and aft balloon 20
are in their deflated condition when novel apparatus 5 is sealed
within sterile package 1000.
[0184] While fore balloon 35 and aft balloon 20 are stored within
package 1000 in their deflated condition, it has been found that it
is sometimes possible for a small amount of residual air to remain
within fore balloon 35 and/or aft balloon 20 and/or the various
fluid pathways leading to fore balloon 35 and/or aft balloon 20
(e.g., hollow push tubes 30, push tube bridge 31, proximal
inflation/deflation tube 45, etc.). As a result, when novel
apparatus 5 (sealed within package 1000) is thereafter shipped to a
recipient via a means of transportation where package 1000 is
exposed to a substantial change in air pressure (e.g., when novel
apparatus 5 is shipped to a recipient via an airplane), the change
in air pressure can cause the residual air remaining within fore
balloon 35 and/or aft balloon 20 (and/or the various fluid pathways
leading to fore balloon 35 and/or aft balloon 20) to expand. Such
expansion while novel apparatus 5 is sealed within package 1000 can
cause damage to fore balloon 35, aft balloon 20 and/or other
components of novel apparatus 5.
[0185] One possible solution to the foregoing problem is to fully
evacuate all of the air from fore balloon 35, aft balloon 20 and
all of the pathways, leading to fore balloon 35 and aft balloon 20
before novel apparatus 5 is sealed within package 1000. However, it
has been found that it can be challenging to evacuate all of the
air from fore balloon 35, aft balloon 20 and the pathways leading
to fore balloon 35 and aft balloon 20. In addition, it has also
been found that it can be challenging to ensure that no air is
thereafter able to leak back into any of the evacuated components
of novel apparatus 5.
[0186] Another possible solution is to allow the air within the
interior of package 1000 to freely enter and exit the components of
novel apparatus 5, e.g., by leaving one or both of fittings 46, 56
open to airflow, etc. However, with such an "open valve"
configuration, the recipient (e.g., the surgeon) would need to be
diligent in closing any open valves prior to using novel apparatus
5. It is possible that a recipient may inadvertently leave a valve
open that should be closed prior to using novel apparatus 5,
thereby causing malfunction of novel apparatus 5.
[0187] Thus there is a need for a new and improved way to maintain
a free exchange of air between the interior of package 1000 and
fore balloon 35 and aft balloon 20, while automatically sealing off
that free exchange of air when the user removes novel apparatus 5
from package 1000.
[0188] To this end, and looking now at FIG. 84, a fore balloon
venting check valve 1015 and an aft balloon venting check valve
1015A are provided in hand inflator 300, with fore balloon venting
check valve 1015 being disposed in fore balloon inflation line 320
and with aft balloon venting check valve 1015A being disposed in
aft balloon inflation line 315. For clarity of illustration, only
fore balloon venting check valve 1015 is shown in FIGS. 85-88 and
discussed in detail hereinbelow, however, it should be appreciated
that aft balloon venting check valve 1015A is identical in
construction and function to fore balloon venting check valve 1015
(although aft balloon venting check valve 1015A is disposed in aft
balloon inflation line 315 rather than in fore balloon inflation
line 320).
[0189] Looking now at FIGS. 85-88, fore balloon venting check valve
1015 and aft balloon venting check valve 1015A are disposed in the
bottom surface of housing 305 of hand inflator 300, such that they
are in fluid communication with fore balloon inflation line 320 and
aft balloon inflation line 315, respectively, and hence in fluid
communication with fore balloon 35 and aft balloon 20,
respectively. More particularly, fore balloon venting check valve
1015 comprises a lumen 1020 having a first end in fluid
communication with fore balloon inflation line 320 and a second end
having an opening 1025 formed in the outer surface of housing 305.
A ball (e.g., a rubber ball) 1030 is movably disposed within lumen
1020 and is biased against opening 1025 by a spring 1035. When ball
1030 is biased against opening 1025, air cannot pass through
opening 1025 and into (or out of) fore balloon inflation line 320,
i.e., fore balloon 35 is sealed off against the free passage of air
into (or out of) fore balloon 35.
[0190] Bottom tray 505 comprises an upwardly-extending finger 1040
which is sized and positioned such that finger 1040 is received
within opening 1025 of housing 305 when novel apparatus 5 (and,
more specifically, hand inflator 300) is disposed within bottom
tray 1005 of package 1000. Finger 1040 is sized such that when it
is received within opening 1025, a finger 1040 engages ball 1030
and drives ball 1030 against the power of spring 1035, whereby to
unseat ball 1030 from opening 1025. At the same time, a gap remains
between finger 1040 and the sides of opening 1025, whereby to allow
air to pass from the interior of package 1000 through fore balloon
venting check valve 1015, through fore balloon inflation line 320
and into fore balloon 35, and vice versa (FIG. 87).
[0191] Bottom tray 1005 comprises a similar finger 1040A for
forcing check valve 1015A open when hand inflator 300 is seated in
bottom tray 1005 of package 1000.
[0192] If desired, an upwardly-extending stop (not shown) may also
be provided on bottom tray 1005 of package 1000 for engaging the
bottom surface of housing 305 of hand inflator 300 when hand
inflator 300 is disposed within bottom tray 1005 of package 1000,
whereby to ensure that an air gap is maintained between the bottom
surface of hand inflator 300 and the bottom surface of bottom tray
1005, and hence ensure that air is free to flow through check
valves 1015, 1015A when hand inflator 300 is seated in bottom tray
1005 of package 1000.
[0193] As a result of this construction, when novel apparatus 5 is
disposed in bottom tray 1005, fingers 1040, 1040A open fore balloon
venting check valve 1015 and aft balloon venting check valve 1015A,
respectively, so that air is permitted to freely enter into, and
exit out of, fore balloon 35 and aft balloon 20 via fore balloon
venting check valve 1015 and aft balloon venting check valve 1015A,
respectively. This eliminates the aforementioned problems
associated with exposing package 1000 to substantial changes in air
pressure (e.g., during shipping) and prevents damage to apparatus 5
during shipping.
[0194] When apparatus 5 is to be used, cover 1010 is removed from
package 1000 and novel apparatus 5 is removed from bottom tray
1005. When this occurs, fingers 1040, 1040A are withdrawn from fore
balloon venting check valve 1015 and aft balloon venting check
valve 1015A, respectively, thereby allowing these check valves to
return to their "closed" positions.
[0195] Thus it will be seen that fore balloon venting check valve
1015 and aft balloon venting check valve 1015A act to protect novel
apparatus 5 from exposure to air pressure differentials during
shipping/storage and does so in a passive fashion that does not
require the recipient to close any valves.
Preferred Method of Using the Novel Apparatus
[0196] 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 which may be initially
hidden from view 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 working ends of
instruments (e.g., graspers, cutters or dissectors, cauterizing
tools, ultrasound probes, etc.), e.g., advanced into the
therapeutic zone.
[0197] 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, with endoscope 10 nesting in the area beneath raised
push tube bridge 31. Endoscope 10 and apparatus 5 are ready to be
inserted as a unit into the patient.
[0198] Looking next at FIG. 89, 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. 90 and 91).
[0199] 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.
92. This may be done using the aforementioned associated inflation
mechanism 40.
[0200] 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.
[0201] Next, hollow 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, hollow 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 raised push tube bridge 31 provides an
atraumatic tip for the distal ends of hollow push tubes 30, thereby
ensuring atraumatic advancement of fore balloon 35. Note that the
deflated fore balloon 35 covers the distal ends of hollow push
tubes 30 and raised push tube bridge 31 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 hollow push tubes 30 and raised push tube bridge 31 out of a
more resilient material.
[0202] When hollow push tubes 30 have advanced fore balloon 35 to
the desired position distal to endoscope 10, fore balloon 35 is
inflated (FIG. 93) 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 hollow
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 which may be initially hidden
from view or outside the field of view) for examination and/or
treatment during an endoscopic procedure using endoscope 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 hollow 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
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.
[0203] 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
hollow 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 further tension the side wall
of the body lumen and/or body cavity.
[0204] 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 inflated (FIG. 24) with
a fluid (e.g., air, CO.sub.2, 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. 95), e.g., so as to position a
particular target area on the side wall of the body lumen and/or
body cavity at a convenient angle relative to the endoscope and
endoscopic tools.
[0205] Alternatively, if desired, once aft balloon 35 has been
inflated, hollow push tubes 30 may be advanced distally a
portion--but only a portion--of their full distal 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 hollow push tubes 30 may be
further advanced distally. This action will cause flexible hollow
push tubes 30 to bow outwardly (see FIGS. 96-99), 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
"tenting" fashion, whereby to further enhance visualization of the
side wall of the body lumen and/or body cavity by endoscope 10.
[0206] If desired, instruments 190 (FIG. 100) 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 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
instruments having a full range of motion, whereby to better access
target anatomy.
[0207] 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 the therapeutic zone lies
(e.g., with a liquid such as saline) with rapid subsequent removal
of the flushing liquid (see FIGS. 101-103).
[0208] 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 local pressure to the bleeding site in
order to enhance bleeding control (see FIG. 104). This can be done
under the visualization provided by endoscope 10.
[0209] 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 (with endoscope 10 nesting in the area
beneath raised push tube bridge 31), 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.
[0210] 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, hollow push tubes 30
are advanced distally, and then fore balloon 35 is inflated (FIG.
105). Visualization and, optionally, therapeutic 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. 106), 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. 107, with or without introduction of a fluid into the
"isolated therapeutic zone" established between the two balloons,
so as to stabilize, straighten, expand and/or flatten the
anatomy.
[0211] 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.
[0212] 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
hollow push tubes 30 so that fore balloon 35 is "re-docked" onto
the distal end of endoscope 10 (with endoscope 10 nesting in the
area beneath raised push tube bridge 31), fully deflating fore
balloon 35 so 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.
[0213] 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 hollow push tubes 30 (and raised push
tube bridge 31) 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 hollow 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 hollow push tubes can deflect so that the fore balloon
tracks the path of the colon, thereby aiding atraumatic advancement
of the endo scope 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 the lumen which would be facilitated by
the fluid-filled inflated fore balloon and ultrasound probe
examination.
Improved Aft Balloon Thermal
Bonding Using Insert Material
[0214] Aft balloon 20 is bonded to sleeve 15 along at least the
distal edge of aft balloon 20 and the proximal edge of aft balloon
20 (i.e., the distal and proximal edges where aft balloon 20 meets
sleeve 15), such that an airtight seal is created between aft
balloon 20 and sleeve 15. Pushrod lumens 52 and aft balloon
inflation lumen 47 are disposed in contact with, and parallel to,
sleeve 15, with pushrod lumens 52 passing entirely through aft
balloon 20 (i.e., through both the proximal and distal edges of aft
balloon 20 where aft balloon 20 meets sleeve 15) and with aft
balloon inflation lumen 47 passing through the proximal edge of aft
balloon 20 and extending into the interior of aft balloon 20. As a
result, aft balloon 20 must be sealingly bonded to sleeve 15 about
a series of components (i.e., pushrod lumens 52 and aft balloon
inflation lumen 47) which collectively present a non-circular
cross-sectional profile at the bonding sites.
[0215] In practice, it has been found that it is challenging to
effect airtight thermal bonding of aft balloon 20 to sleeve 15,
inasmuch as the presence of pushrod lumens 52 and aft balloon
inflation lumen 47 create open wedges (or corners) which the
material of aft balloon 20 must fill in order to ensure airtight
bonding of aft balloon 20 to sleeve 15.
[0216] More particularly, and looking now at FIG. 108, gaps 1100
exist in the space between pushrod lumens 52 and sleeve 15, gap
1105 exists in the space between aft balloon inflation lumen 47 and
sleeve 15, and gaps 1110 exist in the space between a pushrod lumen
52 and aft balloon inflation lumen 47. The presence of gaps 1100,
1105 and 1110 at the proximal edge of aft balloon 20, and the
presence of gaps 1100 at the distal edge of aft balloon 20,
compromise the airtight sealing of aft balloon 20 to sleeve 15,
since it is difficult to make the material of aft balloon 20 adhere
to the irregular perimeter defined by pushrod lumens 52 and aft
balloon inflation lumen 47. Stated another way, it can be
challenging to make the material of aft balloon 20 enter into gaps
1100, 1105 and 1110.
[0217] Thus it would be desirable to provide a new and improved
means to fill gaps 1100, 1105 and 1110 so that aft balloon 20 can
be thermally bonded to sleeve 15 in an airtight sealing
engagement.
[0218] To that end, and looking now at FIGS. 109, 110, 111, 112,
113 and 114, there are provided novel extruded inserts 1115 which
have a cross-sectional profile matching the aforementioned gaps
1100. Extruded inserts 1115 are sized to fill gaps 1100 at the
location where the proximal edge of aft balloon 20 and the distal
edge of aft balloon 20 are bonded to sleeve 15 around pushrod
lumens 52. Extruded inserts 1110 are preferably flexible and may be
of any desired length (e.g., extruded inserts 1115 may extend along
substantially the entire length of sleeve 15, or extruded inserts
1115 may extend only along a portion of sleeve 15 where aft balloon
20 is bonded to sleeve 15, or a plurality of extruded inserts 1115
may extend along a plurality of interrupted sections of sleeve 15,
etc.). In one preferred form of the invention, extruded inserts
1115 extend from a location just distal to aft balloon 20 to a
location just proximal to aft balloon 20.
[0219] There is also provided a novel extruded insert 1120 having a
cross-sectional profile matching the aforementioned gap 1105.
Extruded insert 1120 is sized to fill gap 1105 at the location
where the proximal edge of aft balloon 20 and the distal edge of
aft balloon 20 are bonded to sleeve 15 around aft balloon inflation
lumen 47. Extruded insert 1120 is preferably flexible and may be of
any desired length (e.g., extruded inserts 1120 may extend along
substantially the entire length of sleeve 15, or extruded inserts
1120 may extend only along a portion of sleeve 15 where aft balloon
20 is bonded to sleeve 15, or a plurality of extruded inserts 1120
may extend along a plurality of interrupted sections of sleeve 15,
etc.). In one preferred form of the invention, extruded insert 1120
extends from a location at the distal end of aft balloon inflation
lumen 47 to a location just proximal to aft balloon 20.
[0220] There are also provided novel extruded inserts 1125 having a
cross-sectional profile matching the aforementioned gaps 1110.
Extruded inserts 1125 are sized to fill gaps 1110 at the location
where the proximal edge of aft balloon 20 and the distal edge of
aft balloon 20 are bonded to sleeve 15 around aft balloon inflation
lumen 47 and a pushrod lumen 52. Extruded inserts 1125 are
preferably flexible and may be of any desired length (e.g.,
extruded inserts 1125 may extend along substantially the entire
length of sleeve 15, or extruded inserts 1125 may extend only along
a portion of sleeve 15 where aft balloon 20 is bonded to sleeve 15,
or a plurality of extruded inserts 1125 may extend along a
plurality of interrupted sections of sleeve 15, etc.). In one
preferred form of the invention, extruded insert 1125 extends from
a location at the distal end of aft balloon inflation lumen 47 to a
location just proximal to aft balloon 20.
[0221] Inserts 1115, 1120 and 1125 are preferably formed out of a
material which will thermally bond with the material(s) of (i)
sleeve 15, (ii) pushrod lumens 52, (iii) aft balloon inflation
lumen 47, and (iv) aft balloon 20, whereby to facilitate the
airtight bonding of aft balloon 20 to sleeve 15, pushrod lumen 52
and aft balloon inflation lumen 47.
[0222] It should be appreciated that where additional
components/lumens (e.g., working channels) are disposed coaxially
about sleeve 15, additional extruded inserts 1115, 1120, 1125, etc.
may be provided, and/or other extruded inserts of different sizes
and/or cross-sectional profiles may be provided, without departing
from the scope of the present invention.
Improved Fore Balloon Construction
[0223] With the "double eversion" fore balloon construction
discussed above, fore balloon 35 is formed as a hollow balloon body
67 having two extensions (i.e., proximal extension 73 and distal
extension 76) which are both everted inwardly (i.e., the proximal
extension is everted first, the distal extension is everted second)
into the interior of body 67 and thermally bonded together to form
fore balloon 35. With this approach, fore balloon 35 comprises a
torus, whereby to facilitate docking of fore balloon 35 over the
distal end of sleeve 15 (i.e., the distal end of endoscope 10) when
fore balloon 35 is in its deflated condition. At the same time,
fore balloon 35 can provide a full-diameter barrier across an
anatomical passageway when fore balloon 35 is in its inflated
condition.
[0224] However, it has been found that it can be challenging to
effect good thermal bonding between inwardly-everted proximal
extension 73 and inwardly-everted distal extension 76, inasmuch as
both proximal extension 73 and distal extension 76 are located
within the interior body 67 of fore balloon 35 during bonding, and
therefore can be difficult to access during component bonding.
[0225] One solution to this problem, and looking now at FIGS.
115-119, is the provision of an alternative fore balloon 35A. Fore
balloon 35A is manufactured as a single construct comprising a body
67A having a proximal opening 69A and a distal opening 71A, a
proximal extension 73A having a "key-shaped" cross-section
comprising lobes 74A, and a distal extension 76A having a circular
cross-section. Note that lobes 74A of proximal extension 73A have a
configuration that matches the configuration of hollow push tubes
30 (i.e., where apparatus 5 comprises two hollow push tubes 30
diametrically opposed to one another, proximal extension 73A
comprises two lobes 74A diametrically opposed to one another--for
the purposes of the present invention, proximal extension 73A and
lobe(s) 74A may be collectively referred to as having a
"key-shaped" cross-section). Proximal extension 73A is relatively
short and is preferably flared outwardly at its proximal end,
whereby to facilitate docking of fore balloon 35A over sleeve 15
and/or endoscope 10 as will hereinafter be discussed in greater
detail. Furthermore, proximal extension 73A preferably comprises a
proximally-extending tongue 77 for facilitating docking of fore
balloon 35A over the proximal end of sleeve 15 (and/or the proximal
end of endoscope 10).
[0226] Thus it will be appreciated that fore balloon 35A is formed
in a manner generally similar to the aforementioned fore balloon
35, except that proximal extension 73A of fore balloon 35A differs
from the aforementioned proximal extension 73 of fore balloon 73
(i.e., by being formed with a shorter length, a flared proximal end
and a tongue 77).
[0227] Fore balloon 35A is also assembled in a somewhat different
manner than the aforementioned fore balloon 35, as will hereinafter
be discussed in greater detail. More particularly, and looking now
at FIGS. 120-122, hollow push tubes 30 are seated in lobes 74A of
proximal extension 73A, with proximal extension 73A extending
proximally away from fore balloon 35A and with distal extension 76
extending distally away from fore balloon 35A. Hollow push tubes 30
are advanced distally into the interior of body 67A of fore balloon
35A such that the interiors of hollow push tubes 30 are in fluid
communication with the interior of body 67A and with raised push
tube bridge 31 disposed within the interior of body 67A. If
desired, an assembly mandrel M may be used during assembly in order
to provide support for the components during insertion of hollow
push tubes 30 into fore balloon 35A of fore balloon 35A (see FIG.
120).
[0228] Next, processing mandrel M is removed (if one is used), and
distal extension 76A is everted into the interior of body 67A of
fore balloon 35A and passed proximally through body 67A, and
through the interior of proximal extension 73A, until distal
extension 76A extends to the proximal opening of proximal extension
73A. As a result of this construction, proximal extension 76A
extends through body 67A, and both proximal extension 73A and
distal extension 76A extend proximally away from body 67A of fore
balloon 35A, and push tubes 30 are disposed between proximal
extension 73A and distal extension 76A proximal to body 67A of fore
balloon 35A. Thus, in this form of the invention, proximal
extension 73A is not everted into the interior of fore balloon 35A,
rather, proximal extension 73A remains extending proximally away
from fore balloon 35.
[0229] Proximal extension 73A and distal extension 76A are then
bonded together at their proximal ends, with push tubes 30 being
sealed therebetween, such that airtight thermal bonding is
effected.
[0230] As a result of the foregoing, fore balloon 35A has a
toroidal configuration, comprising a boy 67 having a center opening
formed by (i) proximal extension 73A/everted distal extension 76A
on the proximal side of body 67A, and (ii) everted distal extension
76A within the interior of body 67A.
[0231] Significantly, this form of the invention results in fore
balloon 35A having a toroidal shape which does not require thermal
bonding to be carried out within the interior of body 67A of fore
balloon 35A, thereby simplifying assembly. Furthermore, by forming
proximal extension 73A as a relatively short structure having an
outwardly flared proximal end, and by providing tongue 77 on the
proximal edge of proximal extension 73A, proximal extension 73A can
facilitate docking of fore balloon 35A over sleeve 15 and/or
endoscope 10.
[0232] If desired, and looking now at FIG. 123, novel extruded
inserts 1130 may be provided alongside hollow push tubes 30 so as
to facilitate bonding hollow push tubes 30 to proximal extension
73A and to the everted distal extension 76A.
[0233] Furthermore, if desired, additional material and/or
extrusions may be provided along either (or both of) proximal
extension 73A and distal extension 76A, and/or around the proximal
opening of proximal extension 73A, so as to provide increased
rigidity to those portions of fore balloon 35A.
Forming the Aft Balloon with an Everted Construction
[0234] If desired, aft balloon 20 may be formed with an everted
construction. More particularly, and looking now at FIGS. 124 and
125, there is shown an aft balloon 20A which generally comprises a
distal extension 1135 and a proximal extension 1140. During
construction, distal extension 1135 is everted back through the
center of aft balloon 20A so as to form a generally toroidal
balloon structure which is secured to sleeve 15. In this form of
the invention, a tube 1145 has its distal end 1150 disposed
exterior to the everted distal extension 1135, and interior to the
outside wall of aft balloon 20A, and its proximal end 1155
connected to the aforementioned proximal inflation/deflation tube
45, so that air (or another fluid) can be introduced into aft
balloon 20A and removed from aft balloon 20A.
Additional Constructions
[0235] If desired, apparatus 5 may be constructed so that hollow
push tubes 30 may be advanced or retracted, to a limited extent,
independently of one another, as well as in conjunction with one
another--such limited independent advancement or retraction of
hollow 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 hollow 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.
[0236] By way of example but not limitation, in this form of the
invention, and looking now at FIG. 126, hollow push tubes 30 are
each independently slidably mounted to push tube handle 37 so that
hollow push tubes 30 can move, to some extent, independently of
push tube handle 37 and each other. Stops 191 limit distal movement
of hollow push tubes 30 relative to push tube handle 37 so that a
hollow push tube cannot be moved completely out of push tube handle
37. As a result of this construction, when fore balloon 35 is to be
moved distally, hollow push tubes 30 are moved distally, either
together or, to the extent allowed by raised push tube bridge 31,
independently of one another. And when fore balloon 35 is to be
moved proximally, hollow push tubes 30 are moved proximally, either
together or independently of one another, to the extent allowed by
raised push tube bridge 31. At any point in a procedure, hollow
push tubes 30 can be moved, to the extent allowed by raised push
tube bridge 31, 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 raised
push tube bridge 31 at the distal ends of hollow push tubes 30
provides a limiting mechanism to limit the extent to which hollow
push tubes 30 may be moved, longitudinally, independently of one
another, in order to prevent excessive turning of fore balloon 35,
and/or hollow push tube cross-over, and/or hollow push tube
entanglement, and/or hollow push tube misalignment, etc. Note also
that hollow push tubes 30 may be held in a particular disposition
by mounting hollow push tubes 30 in the aforementioned clamp 53
(FIGS. 37 and 60).
[0237] 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 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.
[0238] More particularly, and looking now at FIG. 127, 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.
[0239] 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 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. 127, the lumen 47 for 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.
[0240] FIGS. 128-131 show various instruments 190 extending out of
lumens 195. Note that instruments 190 preferably comprise
articulating instruments, e.g., graspers 190A in FIGS. 128-131, a
cauterizing device 190B in FIGS. 128-129, scissors 190C in FIGS.
130 and 131, and a suction device 190D in FIGS. 128-131.
[0241] It should be appreciated that where sleeve 15 comprises its
central passageway for receiving endoscope 10, lumen 47 for
receiving inflation/deflation tube 45, lumens 52 for receiving
support tubes 50 which receive hollow push tubes 30, and/or lumens
195 for slidably receiving instruments 190 therein, sleeve 15 is
preferably formed by an extrusion process.
[0242] In one preferred form of the invention, lumen 47 for
receiving inflation/deflation tube 45, lumens 52 for receiving
support tubes 50 which receive hollow 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.
[0243] In another preferred form of the invention, lumen 47 for
receiving inflation/deflation tube 45, lumens 52 for receiving
support tubes 50 which receive hollow 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.
[0244] 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 hollow 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.
[0245] 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.
[0246] And such hollow instrument guide tubes may be of fixed
geometry or of bendable or articulating geometry. See, for example,
FIG. 132, 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 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.
[0247] In another form of the present invention, the toroidal
construction of fore balloon 35 may be replaced by a "conventional"
balloon construction, i.e., by a balloon having a substantially
uniform, full-diameter cross-section. In this form of the
invention, the deflated fore balloon is not "docked" over the
endoscope during insertion--instead, the deflated fore balloon
resides alongside the endoscope during insertion; and in this form
of the invention, the fore balloon is not "re-docked" back over the
endoscope during withdrawal--instead, the balloon resides distal to
the endoscope (or alongside the endoscope) during withdrawal. It
will be appreciated that, in this form of the invention, the raised
push tube bridge 31 can help retain the deflated fore balloon
alongside the endoscope.
Applications
[0248] 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 which may be
initially hidden from view 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 examination
(including visualization of areas which may be initially hidden
from view 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 which may be initially hidden from view or
outside the field of view) for examination and/or treatment during
an endoscopic procedure.
[0249] 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 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.
[0250] 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, 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
stabilizing the colon (including decreasing deformation of the
colon wall) so as to enable more precise visualization,
intervention and/or surgery.
[0251] 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 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.
[0252] And the present invention provides 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.
[0253] The novel apparatus of the present invention can be used in
substantially 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.
[0254] The present invention is believed to have widest
applications with respect 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 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
[0255] 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, deletions and
modifications may be made to the preferred embodiments discussed
above while remaining within the scope of the present
invention.
* * * * *